Our Health System

2012-01-17T16:03:00.000-08:00

THE SPIRIT SUSTAINING HEALTH CARE REFORM

As my television showed a drove of national political candidates belittling each other, proclaiming their consultant-generated views on what Americans want and "need," calling for changes in national governance, and voicing harsh criticism (coupled with parroting of their contributors' demands for destruction of President Obama's championed Affordable Care Act), I thought of a different era in which a successful American political leadership understood that all individuals are people, created in a holy image, not subservient chattels whose major purpose in life is to make their owners rich.

Reflect on these words (italics - below) from a humble, brave, ethical, heroic American. Take a moment and consider the difference between the spirit conveyed in these words and that which come to us from the recent presidential primary debates, uttered in a small mean way. The American president understood and transmitted the true meaning of freedom and died defending it, as did Rev. King whose memory Americans celebrated yesterday.

Read on and click on the link----

"And upon this act, sincerely believed to be an act of justice, warranted by the Constitution, upon military necessity, I invoke the considerate judgment of mankind, and the gracious favor of Almighty God."

[The Emancipation Proclamation

January 1, 1863

A Transcription
By the President of the United States of America:
A Proclamation.
Whereas, on the twenty-second day of September, in the year of our Lord one thousand eight hundred and sixty-two, a proclamation was issued by the President of the United States, containing, among other things, the following, to wit:

"That on the first day of January, in the year of our Lord one thousand eight hundred....]

2012-01-13T14:09:00.000-08:00

HOW DO LIONS CHOOSE DINNER?

If you have watched television nature programs, you may have seen videos of lions attacking relatively easy game: animals which are very young, very old, sick or separated from the pack. Defenseless against the predatory lion, the young, old, sick and socially isolated are easy prey.

In my experience negotiating health care contracts- and studying the practices of health insurers - I observed similar corporate behaviors. Individual underwriting of pregnant women, in states such as Texas, resulted in their inability to obtain maternity coverage at a point when they needed it the most. Newborns with congenital diseases, which might cost millions of dollars in health care services, led to cost-shifting. Underwriting made those with significant (and sometimes insignificant) health histories unable to obtain insurance or to afford the insurance offered to them (one insurer representative claimed that the company represented had very few HMO members who were over the age of 24). And those, seeking individual health insurance policies, were offered coverage which only the very rich could afford.

Take a look at the article from Kaiser Health News, "Health Law's Individual Mandate, Essential Benefits Draw Headlines." You may find that my metaphor - of predation - is not far off base. The difference is that the insurers, their lobbyists and those in our government, whom their political contributions support, tread our nearby streets, state capitol hallways, and Congressional venues not far off jungles.

2012-01-02T16:01:00.000-08:00

MEDICALLY NONCOMPLIANT: ANYONE YOU KNOW?

Medconditions.net supplies a definition of noncompliance: "Patient or client refusal of or resistance to medical, psychological, or psychiatric treatment. (APA, Thesaurus of Psychological Index Terms, 8th ed.)"

Any experienced physician will tell you that noncompliant patients present serious problems. It is difficult to tell whether a recommendation or prescription is helping the patient because the physician doesn't really know whether the patient is following the recommendation or has filled (or is taking the prescription or treatment in a manner consistent the doctor's instructions). Is the patient's heart function deteriorating because the medicine is not working or is the patient not taking the medicine? Is the patient getting sicker because of the medicine or in spite of it? Is the patient's back pain worsening because there is increasing structural damage to the spine or back muscles or because the patient is not performing the exercise program that, if he or she had gone to the physical therapist, would normally have improved the discomfort?

Ten questions:
1. Are you a patient who doesn't follow the doctor's advice because you have good reasons not to trust the doctor's competence?
2. When the doctor gives you a prescription, do you go to the internet to research the drug or program before filling it?
3. When the doctor gives you a prescription for a generic drug, do you insist that the pharmacist provide the branded version because your insurance will pay for it and the branded drug is better?
4. Do you ask the pharmacist (or has the pharmacist been found) to give you less than the amount of the drug prescribed (i.e., fewer pills) to save money?
5. Do you cut non-scored pills into two or more pieces so that, by taking half a pill daily they will last longer,to save money?
6. Do you take the prescription drug every day as prescribed, or do you skip days?
7. Do you borrow pills from friends, or give some of your supply to friends who are running short?
8. Do you store your pills in the bathroom medicine cabinet (warm, well-lighted and moist) or in a cool dark place which may be a little out of your way?
9. Do you ask the pharmacist for pill bottle caps which are not child resistant because you keep the bottle in your purse or nightstand (including when you visit grandchildren) and find it a nuisance to open the child resistant bottles?
10. Do you put all your pills for the next week in one bottle (such as an old unlabeled medicine container) and take them out as needed?

Note: some of the links which follow are to opinions which may conflict with mine, which also follow.

Comment: 1. If you don't trust the doctor's competence, find another doctor quickly. 2. If you research the drug on the internet (at a reputable site which provides verifiable authoritative evidence for its opinions and information) you may qualify as a patient who pays attention, not a non-compliant patient. 3. The doctor's generic prescription is equivalent in effectiveness and you are wasting money and driving up the nation's health bill. 4. The pharmacist should fill the prescription as written or call the doctor to verify that the doctor agrees with your request. 5. Not only are non-scored pills not suitable for breaking or cutting (the active ingredients may not be distributed evenly throughout the pill and you may get more or less drug than you expect) but your total dose may not be correct. See link above for a conflicting opinion. 6. Skipping days needs to be discussed honestly with your doctor because you are not getting the treatment program the doctor expects. 7, Giving or taking pills may harm yourself or someone near and dear to you because the pills may be out of date, another strength, or perhaps inactive pills bought on the internet. 8. Some medicines seriously degrade in warm moist well-lighted environments and may actually damage you (i.e., your kidneys). 9. Kids experiment by taking grandparents' pills and get sick. Get child resistant caps and always use them. Don't be responsible for the illness or death of a child. 10. The unlabeled or incorrectly labeled bottle full of pills is the bane of emergency department doctors: they have to figure out what the pills are, whether you have taken them, and how they were prescribed. Keep pills in clearly marked original containers.

HAPPY SAFE HEALTHY NEW YEAR.

WH0 CAN I TRUST???

2011-12-25T21:00:00.000-08:00

My mailbox reaches the flood stage each day, overflowing as waves of medical information from sources which I know to be reliable (i.e., The New England Journal of Medicine, the Medical Letter and a few others), and sources which have suddenly popped up and pass for authentic reliable information and advice (often with names including the words"institute" or "association") appear.

My problem is that most of what I receive comes from sources which do not disclose whether they represent vendors of drugs and equipment or are truly independent. How can I trust information which comes from cloudy sources which may be forwarding advertisers' hype? Why are providers of medical information not required to fully disclose conflicts of interest to the people who write the prescriptions and orders for the products they are promoting?

Even more confusing are academic sources. How do I know whether a report from a well-known investigator or institution is truthful, is part of an effort to attract more and better paying patients, or part of a plan to attract more grant money to support a training or research program?

It would not be improper for patients to ask physicians for their evidence supporting medical diagnoses and physician recommendations for testing and treatment and then to further ask the physicians for hard information about the reliability of the source of that information. The patient may get some strange looks and responses to such questions, but the physician being questioned will be more careful with, and respectful of, the person who asks. And as a patient - that's what you deserve.

A CONSULTATION WELL DONE

2011-12-14T21:15:00.000-08:00

When I was in active clinical medical practice, some times I ran late. Patients could find themselves in the examining room a quarter or half hour after their scheduled appointment had passed. I would explain that when an emergency arose, I had to deal with it and interrupt my normal appointment flow. And then I explained that I would do the same for them if the need arose - and kept my word.

So, when my Cutaneous Oncology consultant ran late today for my scheduled appointment, it was not an issue. I kept in mind the reason I was in his office, mentally highlighted his credentials and skill set - and was rewarded by an excellent consultation experience. The remainder of this blog will deal with my definition of an excellent Oncology (Melanoma) consultation.

1. Timeliness. My consultation was scheduled in a timely manner, neither too quickly (which would have denied the consultant the opportunity to communicate with other doctors involved in my care or review my records) nor too late (after critical time periods for care had passed). Adequate time was reserved and the consultant extended our session to cover important subjects.

2. History. The consultant was well-prepared through his discussion of my "case" with other professionals involved in my care and his review of my electronic medical record. But he went through many targeted questions, eliciting additional information relevant to my melanoma, my general health, and specific conditions which would need to be considered before treatment recommendations could be made.

3. Physical Examination. A medical assistant recorded routine vital signs, but the consultant performed a targeted thorough physical examination. An experienced competent physician, could cover all of the relevant physical diagnosis issues in five minutes or less. He did.

4. Discussion of Findings/Formulation of Evidence-BasedTreatment Plan. In a careful, thorough, humane and frank manner, and without leaving out important considerations, the consultant reviewed pertinent findings in my medical records, history, and physical examination. He then discussed relevant data from scientific studies of melanoma from his own vantage as a hands-on treating physician, as well as an academic expert on the disease. Going further, he discussed the strengths and weaknesses of the available scientific data, current professional biases among oncologists, the economics of treatment, and his conclusions concerning the application of all of the data he collected, and evidence-backed scientific data to formulate a prognosis and treatment plan. Throughout this process, he distinguished his professional opinions based on personal experience from positions favored by the weight of reliable data. All of this discussion was carried-out in understandable language, though reference to some of the currently available pharmaceuticals and intricacies of acquired resistance to treatment by melanoma and the biology of the immune response of one's body to melanoma may have been difficult for my wife, who accompanied me.

5. Planning for The Next Step. I left the consultation with a clear understanding of the next steps to be taken by the consultant and his plans for further communications with my other physicians and me.

Some of the information I gained today was serious and disturbing. But there was a sense of completeness, professionalism and competence that made the consultative experience worthwhile. After all, adults need to discuss major health issues seriously and make serious informed decisions.

I left the consultant's office to attend a biomedical ethics committee meeting elsewhere, reassured by the high quality of the care I had just received.

"SMART" CANCER OUTWITS PHARMACEUTICAL/MEDICAL RX

2011-12-06T21:33:00.000-08:00

The most effective treatment for professional arrogance among health care providers is years of experience. New doctors imagine themselves to be like knights of old, battling and defeating life-threatening disease if they attack with sufficient resources and vigor. Older doctors understand that a more appropriate description may be that they are more akin to medical anthropologists, watching patients' disease processes reveal themselves, and defy medical and pharmaceutical attacks.

A very recent report from the National Institutes of Health.indicates that Dr. David Solit, and his colleagues, of Memorial Sloan-Kettering CancerCenters has "...discovered a new way that melanoma cells may become resistant to treatment with vemurafenib (Zelboraf), a targeted therapy that has produced dramatic, if transitory, results for some patients with advanced disease." Solit discovered that resistant melanoma cancer cells "...produce a shortened version of the mutant BRAF protein that vemurafenib targets. The shortened protein—which is missing its middle section—is active even in the drug's presence, the researchers reported online November 23 in Nature."

The report indicates that there is some hope that vemurafenib, when combined with another drug (s) may overcome the resistance which has caused treatment response to be transitory. When one considers that a 1 cm. tumor mass may contain 10 to the ninth cancer cells, and there is a significant likelihood that there will be other treatment-resistant mutations among those cells, it becomes evident that therapeutic enthusiasm has to be tempered by hard cold statistics. In an environment in which a single mutation may confer a significant competitive advantage to the mutation-carrier cell and its progeny, one should be cautious about provoking curative expectations.

I hope that oncologists share the statistical likelihood of mutation vs. cure with patients when offering courses of difficult, expensive, time and resource-consuming treatment. Isn't that what "informed consent" is really about?

THE DRILL

2011-12-03T22:18:00.000-08:00

Professionally, I am accustomed to using the shorthand term RoRx for radiation treatment, so that's what I will use in this posting. Of course, in the days when I used "RoRx" I was the doctor and now I am the patient. Very very different roles.

I started my treatment on November 30, the first of 25 scheduled. The third day, of my therapy experience in RoRxland was memorable. Again, I was impressed by the professionalism and competence of the physician and radiation therapist community with whom I came in contact. This was not childs' play and I was treated as an informed adult - after the staff had done its work to inform me of what was going to happen and what I could reasonably expect.

In the treatment room there are two major features, the Varian Linac (linear accelerator) and the treatment table. I had been fitted for an immobilizing treatment mask several days earlier and that mask noisily clipped to the table on which I was lying on my back, locking me in place. The difficult chore was obeying the instruction to not attempt to help the staff who were meticulous in moving me into the exactly right position. Finally, when I was lined up to their satisfaction, the Linac was turned on with buzzing and flashing lights. The table wiggled and jiggled as it positioned me to receive the radiation in precisely measured doses.

A few minutes into the RoRx treatment, lights began to flash and a loud penetrating horn signalled a fire drill. You may be able to imagine my thoughts as I considered the possibility of a fire, or natural disaster, in the midst of an RoRx session, with me firmly affixed to the table(sort of like a pinned butterfly in a collection) The drill must have ended successfully because I received reassuring advice from the technicians, no fire fighters came rushing in to rescue me, and I have no visible indications of any untoward damage. It was "just a fire drill."

Fifteen minutes after the Linac started, I was finished. No immediate pain or discomfort. No impediment to walking out of the room or - later, driving my car. The problems with treatment will come after a number of doses and I left with prescriptions and medication to deal with the complications of RoRx at the time when intervention will be needed. In the meantime I will see a nutritionist in several days to work out our anticipated response to difficulty in taking nourishment.

Treatment is no picnic, but there is real comfort in my belief that the people who run the asylum are competent doctors and therapists and not the patients pictured in a different type of medical facility, like the one featured in "One Flew Over The Cuckoo's nest" - but that is another story!

TOO MANY CARDS TO SHUFFLE

2011-11-23T14:36:00.000-08:00

I have never been a collector of other people's business cards nor have I been anxious to pass out my own. But suddenly, I have a stack of business cards from people I barely know, but who will play an important part in my life and treatment. I have glued them into my blue "RoRX" binder.

As I said earlier, I have an environmental disease, malignant melanoma, probably associated with lots of unprotected sun exposure when young and when sunburn and tanning were promoted as culturally appropriate, In those days, the "healthy look" included a significant tan, but if one's ancestry included a fair skin, that look presaged trouble years later as strange spots became cancerous and spread.

So now I am surrounded by people whose business cards not only reflect "MD" and "RN" status, but FACR, RTT, Research Coordinator, PH.D, and BSN appellations as well as the initials of the various professional groups and associations to which they belong. As a person who practiced hematology (involving malignant oncology) I note that medical care no longer reflects a solitary physician-controlled activity, it reflects a team approach involving people who work with - but not necessarily for - the doctor in charge.

Years ago, I received a published research paper from a university medical school professor whose patient I had informed about the nature of the procedure to which that academic had convinced him to participate (I asked the patient to ask the professor about the benefit that he - the patient - would receive from participating in an invasive and potentially dangerous procedure) bearing the inscription "to Henry Kaplan, MD, without whose help this paper would have been published ___ years earlier" I consider it a welcome change to see the inclusion of individuals in care who believe - and act on the principle - that he and she are responsible for providing highly competent care to an informed patient even though even though the individual's business card does not say "MD" or "RN".

I'll figure out all of their names somewhere down the line. I'm sure that I haven't finished accumulating their printed business cards. Pictures on those cards would be a nice addition.

Yesterday, I spent 3 hours at the nearby university hospital which will be providing me with radiation oncology services, met at least 8 non-physician people previously unknown to me and left the facility with the feeling that I had been well cared-for by well trained highly competent professionals who took satisfaction from the work they were doing.

Medical knowledge has improved. And so has medical care.

A WISH BEFORE SURGERY

2011-11-08T20:01:00.000-08:00

My surgeon called yesterday to tell me that he had accomplished every reasonable goal we had talked about, for the surgery performed 9 days' earlier. It is comforting to know that perhaps those prayers and wishes I had before the surgery were answered.

My prayers and wishes were probably a little different what my readers might imagine. So let me share them with you - to give you the advantage of my years of medical practice, sometimes in the operating room when things did not go well during a procedure.

I wished my surgeon a really good night's sleep. I wished him a terrific relationship with his spouse and a home (including parental) life free of tension and difficulty. I wished him enjoyment of his surgical practice and a good professional relationship with patients, with his surgical team, with the nurses and staff people caring for me, and the hospital administration of the institution where he performs surgery (so that he has the environment, equipment, staffing and supplies appropriate for the day's work). I wished him the ability to focus specifically on the issues at hand when he performed surgery on me, to the exclusion of any possible distractions, even momentary ones. I wished him freedom from the oppression of economic burdens, good transportation between his home and the hospital, and a bright sunny invigorating morning which he could enjoy in good health. And I wished him knowledge competence and judgment appropriate for the procedure at hand.

If all of these prayers and wishes were granted, I - the patient - would do just fine.

And I guess that's what happened.

THE "RIGHT" APPROACH - BUT NO GUARANTEES

2011-11-03T15:46:00.000-07:00

The recommendations for surgery were interesting, but I had treated a sufficient number of patients with this aggressive form of skin cancer, and chose to discuss a preliminary option with my physicians. As described a recent blog post, the purpose in having a medical test is to get information which will substantively affect patient care decision-making. And the PET scan ordered by my physician, which showed no activity outside the known location of metastatic melanoma, allowed me to accept my physicians' advice to have surgery.

Did this PET scan offer me a guarantee? No - because no test is 100% accurate or complete (particularly when looking for a few malignant cells outside the known focus of 10,000,000,000 which a cubic centimeter of tumor may contain). But having the test was rational, appropriate and medically indicated. I had the surgery six days ago.

Pathology pending. Further treatment plans pending. More to come.

A QUESTION TO ASK YOUR DOCTOR

2011-10-24T21:17:00.000-07:00

Imagine that you are in your doctor's office and the doctor proposes to send you for an expensive high technology test. or even a series of blood or urine tests at the laboratory. What questions should you ask, and of those questions, where should you start?

The first question that I suggest you ask is: "doctor, how will the results of this test affect the recommendations you will make or treatment you will offer?" If the doctor can't answer that question, the test should not be done. Your high technology test, or blood specimen, should be critical to the physician's decision-making process and the outcome of the test should be an important treatment issue. Technology tests often involve radiation or other potentially toxic exposures and there are small, but real risks associated even with what seem to be"simple" blood tests, not the least of which is an erroneous result which results in more and riskier testing.

If your physicians seems to be offended by your question, find another doctor. You have a right to know the answer before you expose yourself to the expense, inconvenience and risk of what may be an unnecessary testing procedure.

CDC Melanoma Information

2011-10-19T13:25:00.000-07:00

CDC press release worth reading: CDC melanoma information.
For more information (be patient, the connection is slow), click here.

It's My Lump

2011-10-16T19:44:00.000-07:00

If you have read my recent blog about lumps, you may recall that I described a series of steps frequently followed by physicians (and other medical health care providers) to determine the cause of a patient's lump.
That blog wasn't just an academic discussion: for me it predicted what would soon be my reality.

Because of my years of medical experience caring for patients with malignancies, I had a disquieting impression that I had found a facial lymph node lump containing metastatic malignant melanoma which had spread from the lesion near my brow which had been removed several months earlier. My physicians went through the same steps as I described in my recent blog, including the biopsy and soon confirmed my impression.

The work-up is still in progress. When it has been completed, the next step will be sitting down with my physician and (individually) with the expert consultants who are, or will be, involved in my care to determine whether therapy which is likely to help is available. I have had the good fortune to have good people who have offered various means of help and access to help. But the simple fact remains that I have an aggressive metastatic malignant disease.

I will share some of my experience navigating Our Health System as I travel the melanoma pathway. But for now, my advice to readers is - use appropriate sunscreens and garments that prevent sunburn, avoid tanning beds, and locate a competent dermatologist in your area. If you, or someone who knows you, finds a mole that has changed, see a physician promptly.

HIV and DEMENTIA

2011-10-07T15:50:00.000-07:00

A few months ago, I sent my update of my Chapter concerning the HIV-infected health care worker off to the American Health Lawyers Association who, in turn provided it to Reuters, the publisher of the encyclopedic legal text, Health Law Update. Again, I emphasized the problem of dementia associated with HIV infection and the possible subtle effects of dementia on the judgment of health care providers infected with the virus. I suggested that those with HIV who work in health care be evaluated periodically for evidence of neuro-psychological impairment to protect patients, the infected providers and the institutions in which they provide care.

Today (10/07/2011), Medline Plus (HealthDay) , from the National Institutes of Health and the U.S. National Library of Medicine issued a report by Robert Preidt describing medical research at the University of North Carolina concerning identification of ".... two genetically distinct types of HIV in the cerebrospinal fluid (CSF) of patients with HIV-associated dementia... may help explain why the risk of developing neurological difficulties increases as AIDS patients live longer, and may also help predict which patients are at greatest risk for the problem, according to the U.S. scientists."

This is an important scientific advance which may lead to improved diagnosis and treatment of those who are HIV-infected and, if they are health care providers, to safeguarding the people to whom they render medical care and services.

Fiscal Year 2012 HHS OIG Work Plan

2011-10-05T13:16:00.000-07:00

The Federal Inspector General for Health and Human Services performs the vital function of preventing (when it is feasible) and finding (when it has occurred) health care fraud and abuse. The OIG is involved in bringing order and justice to the system. Because health care comprises about 17% of our gross domestic product, the potential financial reward for fraud is enormous and the opportunity for individuals and organized criminal groups to steal from the citizens of the United States is substantial.

The OIG's Green Book "sets forth various projects to be addressed during the fiscal year by the Office of Audit Services, Office of Evaluation and Inspections, Office of Investigations, and Office of Counsel to the Inspector General."

If you are health care provider, health care attorney, administrator, financial advisor or involved in payment for health care services, the Green Book is an important read. And if you plan to make your living by defrauding our government, taxpayers, those who pay health care bills, the Green Book sends a clear warning: our government goes after cheaters.

Federal Over & Under Payment for Health Care-How Much & For What?

2011-10-04T09:57:00.000-07:00

The Affordable Care Act has brought us significant new information about federal over and under payments to providers, including physicians, hospitals and durable medical equipment providers. The report has been marked as "confidential" but has been released and is available on the internet from the government site. Whether you are an auditor, provider, patient, taxpayer, or a lawyer who represents providers who have been charged with overbilling the government this report on our government's audit program is worth a read. Click here.

Melon Colic

2011-10-01T13:53:00.000-07:00

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm60e0930a1.htm?s_cid=mm60e0930a1_e&source=govdelivery

All you want to know about one of the current outbreaks of listeriosis. And more.

10/3/2011 And more.

What Does A Lump Mean?

2011-09-27T14:00:00.000-07:00

Physicians find lumps all of the time. Most of them are benign and transient (of course the pregnancy "lump" is transient but may not be so benign). So how does a doctor know which lump merits concern and investigation?

The basic tools are straight-forward. A simple history, which addresses a variety of issues including some of the following, may lead to the correct clinical impression: Have you ever had cancer or any unusual growth on your skin or elsewhere? What surgery have you had? How is your appetite? Have you lost weight recently? Have you had sweats at night or experienced fevers which have no obvious explanation? Have you been exposed to toxic environments or materials in your work or personal activities?

And then, the doctor takes the time to perform a competent examination, examining the lump, skin, lymph node areas, thyroid, abdominal organs, breasts, testicles and other areas which may harbor malignancy and which are accessible to palpation or examination.

Only then, does the doctor consider the differential diagnosis and possible laboratory and radiologic tests which may help to establish a diagnosis and differentiate a benign from a more serious condition. And then, after a discussion with the patient, the doctor orders the standard tests - and specialty focused tests such as fine needle sampling (biopsy) of the tissue in question.

Then the doctor and the patient (and those the patient wants to be involved) discuss the findings, the diagnosis and the treatment options and plan.

Medicine is not television drama. The physician - who has been carefully trained to understand and require each step that I have outlined - collects all necessary information to form an evidence-based diagnosis. Scientific evidence trumps intuition and conjecture.

But What If He's Irrational Because He's Sick?

2011-09-15T10:58:00.000-07:00

Perhaps you have seen the video of the outspoken candidate for US President who raised the issue of someone who has made the decision not to buy health insurance and then, at age 30, becomes sick and will die without medical care. And perhaps you heard his audience response? See Krugman link.

People make economic decisions which affect health care for a variety of reasons, including their inability to pay for what they need. But one of the reasons that people make "bad" decisions is their own health. Cancer may be associated with severe depression which makes a person incapable of making a rational decision on every day things, such as purchasing health insurance. Brain trauma, brain tumors, brain infections, diabetes, Alzheimer's disease and other dementias, metabolic disorders such as Wilson's disease - all may be associated with inappropriate decision making.

The solution - in America - is not to throw these people (or their family members, including their children) onto the junk pile for easy disposal. It is finding the compassion and common sense to treat them humanely and appropriately. It is surprising for someone from a medical family to miss this obvious point. What else is he missing - and is there some medical reason for his missing it?

The Unspoken: A Level Playing Field

2011-09-08T14:58:00.000-07:00

The formation of the United States, and eradication of the nation-like borders that once presented economic and trade barriers between the colonies and later the states, provided that level playing field which led to the development of flexible movement of people, goods and services. Import taxes across state lines were forbidden and relative uniformity of business opportunity became a strong factor favoring competition and economic growth.

But with employer mandated health care insurance for employees becoming optional in many states, and states manipulating health insurance content, some states provided lower costs to certain employers. The playing field became tilted in favor of the states which chose employers' benefits as more important than health care access and availability to working women, men and their children. Competition was for the bottom of the health care barrel.

Health care reform threatens to once more provide access to health care and availability to all Americans through a uniform system. It will level the playing field for all employers, families and individuals. Too bad no one speaks about the anti-competitive advantage that some of the opponents of health care reform seek for their local political bases and contributors. We all know what flows downstream.

Cost Shifting Without Conscience

2011-09-03T20:47:00.000-07:00

When the chief executive of the United States, who professes to be the architect of landmark health care reform, without significant expression of remorse, abandons his support for clean air because it would be detrimental to industry in this time of worldwide financial stress, we see a unique cost shift. Manufacturers may save the few dollars they spend on ceasing to pollute the air that seniors, infants, children and working people breathe , but no one speaks about the costs that are shifted to our citizens, costs associated with ill health and suffering. Unclean air is costly. It makes people sick, filling our emergency rooms, doctors' offices and hospital beds, raising our health care costs.** Sick workers are less productive, raising the cost of production and making American labor less productive and less of a challenger in the world marketplace. Dirty, ozone-rich air destroys buildings and our infrastructure (in addition to lungs) but these costs are omitted from the President's count of national cost and benefit.

The pennies that each manufacturer saves is negligible compared to the health care costs, human suffering, sickness, lost days from work, decreased productivity and infrastructure destruction that filthy ozone-rich air creates.

It makes one wonder what the President of the United States really stands for? Is he really concerned about the health and well being of the men, women and children who are citizens of this country, or is his focus an ill-advised cost shift that might buy him some short-term political advantage? Is this cost-shift from industry -to just plain folks- a matter of politics without regard to conscience?

New link added 9/6/2011
**New link added 9/7/2011

Deadly "Herbal" Health Supplements - Don't Buy, Give or Take Them

2011-08-28T15:39:00.000-07:00

Today's New York Times had a well written article by Natasha Singer about the dangers of imported supplements Americans take for a variety of reasons (a common one seems to be weight reduction) and the risks that these supplements may be deadly, rather than helpful.

Hematologists see patients with very abnormal blood counts (at life-threatening levels) who steadfastly deny taking any medicines and then, after careful questioning by the doctor, admit that they buy and take Chinese origin "herbal" health supplements for their aches, pains, joint problems, excess weight and other non-life threatening conditions. Several years ago I attended a San Francisco hematologists' meeting at which the problem of an "epidemic" of life-threatening aplastic anemia was discussed. A meticulous investigation at the University of California disclosed that medicines sold as "herbal" contained an antiinflammatory agent, butazolidine, which wiped out patients'' bone marrow's blood production. Butazolidine was one of many pharmacologically active ingredients in all purpose pills bought at local shops, not pharmacies.

Read The Times article. Don't take miracle drugs, for which the only miracle is that you survive their serious side effects. Speak to your doctor, nurse or pharmacist for good solid medicine based on science, not the need to make a quick profit on the powerful drugs on the shelf in the back room. And tell your physician about every medicine you take, whether the medicine is by prescription, over the counter, from a health food store, or from the back room shelf of a local shop.

Added 8/31/2011: Read this FDA warning letter to an Asian manufacturer and learn about the seriousness and the magnitude of problems relating to offshore drug manufacture.

A Good Morning

2011-08-25T22:26:00.000-07:00

This morning, as I prepared for a visit to my doctor, I thought about a patient whom I had not seen in many years. He had presented with a complex problem, involving an incorrect diagnosis, given by reputable physicians at a reputable medical center, and treatment proposal, and my job was to establish the correct diagnosis, tell him that he did not need chemotherapy, tell him that the most appropriate treatment at that time was surgical, and help him get on with what turned out to be a long, well-lived life. Early on, I had presented his "case" at an academic conference at a nearby University Medical Center. My last thought about him this morning was that our experience had taught me that no physician should be arrogant about establishing a patient's diagnosis, particularly if in the process meant correcting another physician's diagnosis. After all, the second doctor is always smarter because he has the work of the preceding doctor to look back on and a time interval between that doctor's evaluation and the time the patient presents for further advice, to clarify the situation.

On my arrival at my doctor's office, the nurse brought me to his examining room. She asked me questions appropriate to my visit and that told me that, as his daughter, she had accompanied the patient described above to my office on several visits. She described her father's opinion concerning the way I practiced. She told me about her father's death, a number of years after my retirement from active practice. I did not remember her trips to the office with her father, and told her that, though I did remember significant elements of what he had related to me. I mentioned that I had thought about her father this morning and demurred when she asked me why I had thought about him, questions I later answered.

This time, I was the patient. She and the doctor in the office were the health care professionals. It was a good morning.

An Unrecognized Danger For Patients and Physicians

2011-08-23T13:52:00.000-07:00

Physicians: reading the linked article on Borderline Personality Disorder may save your career.

During my professional work as a health care attorney, representing physicians about whom there had been complaints to the state Medical Board (and occasionally, to the police) I observed a disturbing pattern.A number of the complaints about physicians' behavior came from patients who clinically seemed to have "Borderline Personality Disorder." These were generally new patients to the affected physicians who noticed nothing unusual in their interactions with the patients who subsequently complained, but the results were serious and had serious professional, legal and financial consequences. Physicians and other health care professionals should read this National Institute of Mental Health information guide.

This information may save your professional career and help you to better care for people with borderline personalities.

"Mission Accomplished" and New York Streets' Shell Games

2011-08-18T11:38:00.000-07:00

If you grew up in New York City, or have wandered its streets as a visitor, you have seen people in front of small tables on which there are shells, one of which covers an object (small, like a pea). The object is to get the mark to wager that he can guess which shell covers the pea as the con man moves the shells around, delivers rapid fire patter, and uses distraction and a partner to separate the mark from his money. The keys to this fraud are rapid movement, distraction, and the appearance of simplicity. The shell game is a con which separates people from their money because they don't understand what is going on in front of them.

I wonder whether the well-publicized announcement that our Iraq mission had been accomplished was part of a shell game in which the American people were distracted from the real purpose of their government's executive, advisers and political party while the significant plan was to separate our citizens from $3 billion (and many lives) that the Iraq "mission" has cost, making social and health programs unaffordable and unavailable. We are now told that we cannot afford schools for kids, health care for seniors, medical care for our poor, or even a clean safe environment because our country has been plunged into near bankruptcy by our social programs. Was the real plan to be accomplished on the aircraft carrier during the mission accomplished show a carefully staged charade to deplete our financial resources so that the wealthiest country in the world could not afford social justice programs? Are our pockets now empty - and our ability to provide health care for the poor, sick and elderly wasted - because of a sophisticated con carried out by a politician who appears to have vanished from the national stage and seems to be forgotten (or hidden?) by his political party?

Whose Fox Will Guard the Generic Drug Hen House?

2011-08-13T22:36:00.000-07:00

In large type, The New York Times made a page 1 announcement of a "Deal in Place For Inspecting Foreign Drugs." The article details that generics producers would pay yearly fees of $299 million to finance inspection of non-U.S. based manufacturing plants every 2 years.

This announcement gives me no comfort. The major pharmaceutical company payers control too much of the offshore inspection budget of the FDA and that power of control raises too high a risk of corruption of the system. If Congress approved a fee structure with dollars flowing into the U.S. general fund, rather than being earmarked specifically for FDA offshore inspections, and reasonable appropriations were made by Congress to support the FDA offshore inspection program, there would be a healthy separation between the payers and the FDA/Inspectors. As the proposal now stands, it sounds as if the pharmaceutical industry has strengthened its stranglehold on the FDA, offshore inspections, control of generics, and perhaps on Congressional campaign budgets and solicitations. Keep your eye on that hen house and remember that the foxes are only interested in taking care of themselves.

Considering Robotic Prostate Surgery - Read This Before Seeing the Doctor

2011-08-12T13:56:00.000-07:00

Are business considerations, rather than expertise and patient care considerations, driving robotic surgery. Read this NIH article (National Cancer Institute) before agreeing to where the prostate surgery is to be done, who will be your surgeon and the type of prostate surgery. And good luck!

A Good Question

2011-08-08T20:20:00.000-07:00

A reader asks: "What of Congressional/presidential action that would prevent minor [or major] generic drug price increases." I have waited a few days before responding because I think this serious question deserves thought, rather than a glib answer.

Some of my readers may have read Ezekiel J. Emanuel's "Opinion"article in the Sunday Review section of August 7, 2011's New York Times which touches on some of the issues related to a shortage of generic drugs effective against some cancers. If you haven't read it, you should for it illustrates some of the complexities in this troubling area. [Some of my readers may recall my discussion of the Thursday lunch discussions at which oncologists described their difficulties in obtaining chemotherapy drugs to give their patients, which they ascribed to their purchasing drugs which patients were unable to pay them for, inability to get authorization from some insurers to pay for the drugs (or insurer authorization presenting expensive time-consuming bureaucratic hurdles to authorization), or difficulties accessing the drugs or being paid for their time, energy and staff whose burned up financial resources in the process.] Several of my oncologist colleagues, who were superb physicians, have retired from their practices because (as they expressed it) of dissatisfaction with their ability to properly treat patients under the existing health care practice conditions and because they were operating their practices at a financial loss.)

I have discussed some of the issues concerning the scarcity of generics, and their rising prices (inadequately offset for Medicare Part D patients by price increases for generics which offset any savings the government may have garnered for them when they reach the doughnut hole (i.e., 7%). Congress and the President have the capacity to use governmental tools to answer significant questions and take action based on their findings: 1) has there been significant consolidation among generic drug producers (including those offshore) which reduces competition in the industry to the detriment of patients? 2) have large pharmaceutical companies acquired generic drug producers, or entered into joint operating agreements with them, which effectively reduces competition to the detriment of patients? 3) is the federal trade commission carrying out its intended function of promoting competition, or has it been sidelined to protect drug manufacturers from competition? 4) is the legal strategy of certain large pharmaceutical companies inhibiting the appearance of generic versions of their "branded" drugs when they go "off-patent"? 5) is the generic drug approval process inhibiting adequate public access to generics in reasonable quantities and at appropriate prices? 6) does the public have adequate information about the sources (country of origin, capability of the manufacturer, and quality of drug) of generics currently being sold in the United States and is that information based on appropriate investigation of those companies by an FDA which is adequately funded by Congress to carry out those functions? 7) Is the Orphan Drug Law being subverted through the introduction of a drug as a treatment for a rare serious disease and then the application of that drug to other treatments at a protected artificially high price? 8) is there financial transparency throughout the entire drug pharmaceutical production and distribution process or are there numerous unknown intermediaries who jack up the price of drugs without tendering services of commensurate value? 8) is our patent law artificially creating shortages of life saving generic drugs? 9) is the rebate, discount and kickback system applied by pharmaceutical insurers, the government and other actors in this field destructive of consumer protection? 10) and finally, does anyone with political power and authority really give a damn?

Judge For Yourself

2011-08-03T11:06:00.000-07:00

I have reproduced the entire minutes of this FDA meeting for your review. My questions include: what was the real subject of discussion? What was accomplished. Were our citizens' interests represented? What will be the next substantive step? Did Americans get their moneys' worth from this meeting? If you have a sense of disquiet, don't complain to me: direct your comments (with a complete copy or link to this blog) , laudatory or otherwise, to your Congress people.

Medical Devices

Minutes From Negotiation Meeting on MDUFA III Reauthorization: July 15, 2011

FDA - Industry MDUFA III Reauthorization Meeting
July 15, 2011, 10:20 - 2:10 pm
FDA White Oak Building 1, Silver Spring, MD
Room 4101-4105

Purpose

To discuss MDUFA III reauthorization.

Participants

FDA
Malcolm Bertoni	Office of the Commissioner (OC)
Ashley Boam	Center for Devices and Radiological Health (CDRH)
Nathan Brown	Office of Chief Counsel (OCC)
Kate Cook	Center for Biologics Evaluation and Research (CBER)
Natalia Comella	CDRH
Christy Foreman	CDRH
William Hubbard	FDA Consultant
Elizabeth Hillebrenner	CDRH
Toby Lowe	CDRH
Thinh Nguyen	OC
Tracy Phillips	CDRH
Don St. Pierre	CDRH
Ruth Watson	Office of Legislation (OL)
Nicole Wolanski	CDRH
Barbara Zimmerman	CDRH
Industry
Hans Beinke	Siemens (representing MITA)
David Fisher	Medical Imaging Technology Alliance (MITA)
John Ford	Abbott Laboratories (representing AdvaMed)
Elisabeth George	Phillips (representing MITA)
Donald Horton	Laboratory Corporation of America Holdings (representing ACLA)
Tamima Itani	Boston Scientific (representing MDMA)
Mark Leahey	Medical Device Manufacturers Association (MDMA)
Joseph Levitt	Hogan Lovells US LLP (representing AdvaMed)
David Mongillo	American Clinical Labs Association (ACLA)
Jim Ruger	Quest Diagnostics (representing ACLA)
Patricia Shrader	Medtronic (representing AdvaMed)
Janet Trunzo	Advanced Medical Technology Association (AdvaMed)

Meeting Start Time: 10:20 am
To provide context for FDA’s proposed approach to mitigate program uncertainties and advance negotiations, FDA started by summarizing the status of where MDUFA reauthorization discussions stand. From January through April, FDA provided more data and analysis on program performance than ever before. While FDA and Industry did not always agree on the interpretation of these data, the parties engaged in a robust exchange of viewpoints that furthered FDA’s understanding of program performance and Industry’s concerns. Based on these discussions, FDA developed a comprehensive proposal package, which FDA presented in April. In May, FDA presented an initial estimate of resources needed to support the proposal package. Although Industry stated that they do not support the initial estimate, FDA noted that the proposal package was carefully designed to address the concerns identified during the program analysis and voiced by Industry. It represented FDA’s good faith estimate of what is needed to address the needs of an under-resourced program to improve transparency, consistency, and predictability, and to achieve the public health outcomes on which all agree. FDA also noted that the proposal package was intended to address core program needs without any “frills,” and was prepared by FDA without having the benefit of seeing Industry’s detailed proposals. FDA believed that on May 4 th Industry had agreed to present at the next meeting its detailed proposals for a 5-year program based on the topics Industry had presented on May 4th. On June 1 st, Industry proposed a different approach, which FDA indicated on June 17th that it could not accept. FDA expressed appreciation for Industry’s June 27 th presentation, which FDA believed reflected forward movement. FDA stated that its proposed approach for today’s meeting was intended to build on that forward movement. FDA indicated its concern, however, that Industry had introduced a new condition to be met before presentation of Industry’s remaining proposals, which it had not originally indicated was a condition for introducing its proposals: agreement on the uncertainty mitigation plan. FDA stated this conditionality could further delay progress on substantive negotiations. FDA explained that timing is critical as, unlike previous MDUFA (re)authorizations, the MDUFA III process includes a sequence of statutory reauthorization process requirements. FDA described this tight timeline to Industry dating back to September 2010, and the FDA remains committed to meeting the statutory timeline despite missed milestones.
FDA responded to Industry’s June 27 th proposal for mitigating uncertainties. FDA indicated that uncertainties will always exist in the oversight of innovative technologies; nobody can predict the exact nature, scope, quality, or volume of submissions over a future five-year period. In the June 17 th meeting, FDA provided a detailed assessment of those initiatives identified by Industry as sources of uncertainty, indicating that they are not expected to have a significant impact on workload or performance in MDUFA III. FDA, in turn, faces substantial uncertainties regarding budget appropriations and legislative uncertainties. FDA suggested that the best way for all parties to manage uncertainty is to accelerate progress on substantive issues in these negotiations.
FDA’s proposed plan for mitigating uncertainties therefore begins with advancing negotiations to reach an understanding of what both parties want the program to look like in MDUFA III, such that the impact of uncertainties can be evaluated in that context. To this end, FDA recommended discussing proposals based on current assumptions and discussing potential impact on workload of initiatives as they are released. FDA asked Industry to present their complete set of detailed proposals on July 26 th so that FDA and Industry can move forward on substantive negotiations, with the goal of reaching an agreement, based on best available information and current assumptions, by the end of August. This timeline would allow FDA to seek expedited Administration clearance prior to publishing draft recommendations in the Federal Register (FR) in October, in order to meet the statutory requirements for public input before delivering final recommendations to Congress by January 15, 2012. FDA is targeting a public meeting in early November during the public comment period. Industry asked what the Agency believed would happen if it transmitted the recommendations to Congress after the statutory deadline. FDA indicated that it is committed to meeting the January 15, 2012 deadline, and that key members of Congress have specifically emphasized this deadline with the Commissioner.
FDA noted that the draft recommendations can be appropriately characterized in the FR notice to accurately reflect contingencies regarding the assumptions underlying any draft agreement. FDA clarified that negotiation meetings may continue after the draft recommendations are published, to the extent necessary to address any potential workload or performance impacts that could arise as more information becomes available during the Fall and FDA resolves several key pending initiatives identified by Industry in their June 27 th presentation. FDA would follow the statutory process currently in place for MDUFA negotiations, including publication of meeting minutes, and concurrent monthly meetings with patient and consumer advocacy groups to obtain ongoing input. If there is a need to revisit any draft recommendations based on workload or performance impacts of newly released initiatives, or in response to public comments or other changes in assumptions (including FDA’s budget authority appropriations), then negotiation meetings would continue. At such meetings, both parties would come prepared with their analysis of a given initiative’s implications for workload and performance. FDA noted that issues unrelated to workload and performance, such as policy, would not be discussed within the MDUFA negotiations but rather, through public comment and meetings directly with Center staff.
FDA reiterated that the Agency does not expect any of the areas of uncertainty identified by Industry to have a significant impact on workload or performance during MDUFA III. Industry asked FDA to define “significant.” FDA clarified that no significant impact refers to impact within the normal level of submission variance or fluctuations experienced from year to year, and they therefore fall within FDA’s ability to manage. Industry also asked what percentage increase in submissions would constitute a “significant” impact. FDA indicated that it is not referring to any fixed percentage change in submissions, and that the size and complexity of submissions would also factor into impact. Industry indicated the need to consider all potential changes, such as those stemming from the 510(k) modifications guidance, 510(k) paradigm guidance, and IOM report together. FDA noted that these documents discuss high-level principles that frame how the program is applied and do not address data requirements. Industry suggested that the 510(k) paradigm guidance could result in an increased number of pages per submission if clinical data are required in more situations. FDA explained that this document simply outlines current practices in more detail. For example, the Agency has historically required clinical data to support a new indication (but not intended use, as that would be NSE). Industry also inquired about the timing and substance of the LDT guidance documents. FDA noted that the Agency had provided information that was available about LDTs on June 27 th, and that this topic could be discussed further prior to reaching a final agreement, once there is more information or the LDT policy is announced. While FDA believes that all initiatives raised to date collectively are not likely to have a substantial impact on workload or performance in MDUFA III, FDA offered to meet with Industry to discuss their concerns with workload or performance after the initiatives in question are released. FDA offered some potential meeting dates in the Fall to hold if further negotiations are needed after the release of draft recommendations.
FDA also noted that the level of budget authority (BA) appropriations for fiscal year 2012 represents a substantial uncertainty for FDA, and could trigger the need for an additional negotiation meeting as it could affect FDA’s ability to meet performance goals at the end of MDUFA II and adversely affect the baseline for MDUFA III going forward. Industry questioned why the FY 2012 appropriations should impact resources available during MDUFA III. FDA responded that the FY 2012 budget will serve as the starting point for the budget at the beginning of MDUFA III, and any significant reductions could affect FDA’s ability to meet goals. Industry questioned whether the proposed House bill with a 12% cut to CDRH would hit the appropriations trigger reauthorized in MDUFA II for the Devices and Radiological Health program line of the FDA budget. FDA indicated it would not; the trigger would only be reached at a 27% cut. Industry indicated that, based on concerns of missing triggers in MDUFMA I, the language in MDUFA II was specifically written to allow minor variation so that the Agency could continue to collect fees under those circumstances and Industry supported that. FDA noted that the appropriations triggers no longer provide their intended level of protection for the program because of increases to BA appropriations in recent years. . FDA also noted the concerns expressed by many outside observers that the Agency has been chronically underfunded. FDA noted that the Government Accountability Office (GAO) criticized the Agency for not doing a better job of identifying the resources needed to address our full set of statutory and regulatory responsibilities. In response to that criticism, the Agency commissioned a study by Booz Allen Hamilton to develop an evidence-based estimate of the resources needed to accomplish all of our medical product oversight responsibilities, which was completed last year. Results showed that all medical product areas, including CDRH, are significantly under-resourced. Industry responded that any chronic under-funding of FDA is a matter for the Administration and Congressional appropriators to address.
FDA provided a formal response to Industry’s June 27 th presentation on proposed enhancements and the use of working groups. FDA agreed with Industry that working groups may be helpful and noted that the Agency initially proposed such groups in April. Based on the current timing, FDA suggested that the purpose of these groups should be to accelerate the process by allowing technical experts on various topics to work in parallel between negotiation meetings. FDA agreed that not all proposal areas may need working groups, and proposed that the structure of the working groups be decided only after Industry has presented its remaining detailed proposals so that an efficient and coherent work plan can be developed taking into account the full scope of discussions. FDA proposed that the negotiators provide a charge to each working group and that each group report back during negotiation meetings.
FDA also agreed to further discuss all proposed enhancements from Industry’s June 27 th presentation: pre-Submission meetings, Refuse to Accept (RTA) procedures for 510(k)s, Refuse to File (RTF) procedures for PMAs, and an independent analysis of review process management. FDA noted, however, that further discussion should take place in the context of a complete set of proposals. Given that many topics are inter-related and resources are limited, FDA suggested that an efficient and coherent approach would mean deferring initiation of work on these proposal areas until the full scope of negotiations has been identified after Industry presents the remainder of their detailed proposals.
FDA proposed a specific path forward and associated timeline. FDA first suggested that a financial working group begin work as soon as possible. Once all proposals are on the table, FDA suggested that both parties agree on the structure and charge for each working group by August 2 nd and that all groups begin work as soon as possible thereafter. FDA noted that some topics may be addressed collectively by a single working group. The working groups should accelerate the process towards a draft agreement which can be cleared by HHS and OMB in time to be published in October.
Industry provided an initial response to FDA’s presentation. Industry stated that the information provided by FDA was encouraging, particularly the Agency’s willingness to meet quickly after issuance of IOM report, 510k modifications guidance, and other important relevant milestones to discuss workload impact. Therefore, Industry will put forward a substantive proposal to cover performance goals, both qualitative and quantitative, on July 26 th. Industry also plans to prepare financial estimates relating to the proposals it shares on July 26th, but it would not be able to provide its financial estimates until after the financial working group is initiated. Industry therefore agreed with FDA that a financial working group meeting should take place soon. Industry indicated their need to discuss FDA’s proposed plan for mitigating uncertainties with their members and ratifiers prior to formally responding; however, Industry stated their agreement on the need to move forward in good faith and come to agreement on a package.
The concept of working groups was discussed further and both parties agreed to establish a financial working group as soon as possible. This group will discuss the MDUFA II spend plan and estimated cost per FTE for MDUFA III.

Next Meeting

The next meeting will take place July 26, 2011.
Meeting End Time: 2:10 pm

Page Last Updated: 08/02/2011
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Wow: Medicare Part D Saves US Money

2011-07-27T10:41:00.000-07:00

Experienced physicians know that patients who don't fill their prescriptions or don't take their medicines as prescribed (often because they can't afford them), are the ones who show up sick in the office or hospital for expensive emergency care and may go on to expensive extended nursing home stays. Now, that clinical experience is confirmed: Study Finds Savings From Medicare's Drug Plan Extend Beyond Cost of Meds.

Your actions can make a difference (see the recent reader's inquiry/comment to my blog about generic prices). Read the NIH report and send a copy of it to your Congressperson's office: urge your Congressperson to champion action which preserves access to Part D medicines through Medicare. Otherwise, as the prices of branded and generic Part D drugs rise, making those medicines unaffordable, America's Medicare health costs will rise.

Every politician counts heads: the number of voters who communicate with Congresspeople will affect the outcome.

The message is clear: Part D medicines save the United States money. Even more important, they keep seniors out of emergency rooms, hospitals and nursing homes, preserving their independence and quality of life.

Added July 27, 2011, 7:52 pm. Information on how the Federal Government and the pharmaceutical companies carry out their mutual functions. Click here.

Medicare and Retirees - Watch Out for Rising Generic Prices

2011-07-25T12:46:00.000-07:00

I have noticed an increase of $1.00 to about $10.00 in the cost of generics I use. Perhaps you have had similar experiences, wonder why and ask yourselves how this will affect your financial security.

The pharmaceutical business is just another free enterprise business which places profits at the top of its accomplishment list when it reports to shareholders and seeks financial support from bankers and investment sources. Brand name drug manufacturers may have subsidiaries which produce generics, and as their patent franchises (i.e., Lipitor and Plavix) expire, you can expect those subsidiaries (or competing generic companies) to be producing generic versions of the branded drugs and to reflect their free-enterprise priorities in doing so. The insurance business, another free-enterprise (subject to some regulation) operation, generates profits by contracting to pay less for the drugs sold to you then your premiums reflect. The difference between their revenues (premiums, copays, rebates, etc.) and their costs (less rebates, etc.) for the drugs they cover pays the big bucks to their executives and more modest returns to individual shareholders.

When the price of a generic increases by a dollar, you, the purchaser, must have $100 in your bank account (at current interest rates) to generate the interest to cover your extra dollar in cost. If you fill 30 generic prescriptions a year you must have thousands of dollars in your bank account to have your interest cover your extra costs. The "minor" increase in generic prices will soon eat away your savings and assets because with the current rate of generic price acceleration that I have seen, you will have to be well-off to generate the return on investment sufficient to pay for the inflation in your drug charges. Obama's health reform plan may control the long-term doughnut whole growth that we have seen in the last two years but seniors and retirees need to pay attention to a political environment where formidable anti-health care reform pressures are being exerted by the party in opposition.

The "minor" increase in generic costs will have a major effect on Medicare-covered Americans and retirees. Make your insurance plan, including Medicare Part D, choice carefully. Shop carefully. And let your Congress people know that you understand what is going on and you expect them to respond to constituent's needs, and not let "minor" generic price increases bankrupt this voting population.

The Debt Ceiling, The Civil War and Health Care

2011-07-24T16:59:00.000-07:00

When the Tea Party, the Republicans, the Democrats and our nation's leaders take political positions based on their articulated fundamental principles, they demonstrate that they have learned nothing from American history.

Our Civil War, fought on the basis of deeply held non-negotiable principles, scarred our country and its families, leaving the South with a deep sense of tragedy from which it has never fully recovered. Fundamental beliefs cannot be negotiated and cannot be compromised. Individuals and parties, unable to walk away from their articulated fundamental beliefs, cannot move the political process forward.

Today, we have a debt ceiling impasse based, not on common sense and the need to solve our problem, but on "fundamental beliefs" which are not to be compromised - which, for the Democrats, means an attachment to social policies which ameliorate perceived societal wrongs and needs (including changes to our health care system) - and for Republicans, become tightly glued to beliefs about the unfairness of taxation, redistribution of America's resources, and "private" enterprise.

I hope that politicians make the political process work. Failure to move compromise forward will have serious national consequences, at a time when many American families are already touched by a national sense of tragedy.

ALMOST PERFECT

2011-07-20T22:05:00.000-07:00

I accompanied a person to the doctor, today, and was impressed with what I saw. First, the staff and the doctor had hard copies of the records, x-rays, reports and materials (from other doctors) he needed. Second, he took a history relevant to the patient's complaint and even prompted for information he thought the patient might have and with a little effort, could produce. Then the doctor actually physically examined the patient. He was comfortable with his examining technique and quality and, as a physician, I felt assured that he was demonstrating not only his interest in the patient, but own competence and integrity. And then he spent a few minutes talking to the patient, reviewing scans and x-rays with the patient, and demonstrating why and how he came to a medical diagnosis, the meaning of that diagnosis, the prognosis and treatment. The visit was everything that a visit should have been.

Unfortunately, if you are a new Medicare patient, this doctor will not be able to see you. He has closed his practice to new Medicare patients.

What Does The Budget Impasse Predict For Health Care?

2011-07-13T20:15:00.000-07:00

Prior to the early 1980's, health insurance was a side business of insurance companies. It is what they had to provide to big employers in order to get their other insurance business which was highly profitable. Then came inflation and things changed. As interest rates climbed and the health insurance business became profitable, among other reasons, because it allowed the insurers to profit from the "float," the insurers suddenly realized that they had hit an inflation gold mine.

One evening, at a dinner, Justice Arthur Goldberg (who told me that he served on the board of a prominent nation-wide health system) asked me what I thought of President Carter. He really wasn't waiting for my answer - and proceeded to tell me that he thought that Carter was lacking in capacity because he allowed interest rates to climb to more than 22% and that was destructive to our country.

I recall one group of physicians who - in the high interest early 1980s found itself paying more than 14% interest rates on loans it needed to continue its practice - and were only available - you guessed it, from insurers!

The danger of the impasse in the budget process, and the Republican refusal to raise the US debt limit, is that the uncertainty surrounding the outcome will force interest rates to rise, again rewarding insurers who manipulate their floats, slow down payment to hospitals, physicians and other providers, and reduce access by patients to what may be desperately needed life-saving services.

So, when the national debt ceiling adjustment is blocked by one party, is one consideration of that party the benefit which will accrue to the insurers who fill its campaign coffers? Is it the strategic ability of that party to further damage our health system. Or is it, as it should be, the well being of the United States of America and its citizens?

The July Turnover Issue

2011-07-12T11:59:00.000-07:00

I was fortunate to have my medical training at a time when the diagnosis of cardiac disease was dramatically improved by x-ray (angiographic) and laboratory techniques (cardiac catheterization) and to have been exposed to superb clinicians, including Maimonides Hospital's (Brooklyn) extraordinary clinician, Dr. William Dressler, the cardiology staff, led by Drs. Harrison and Hancock, at Stanford Medical Center (Palo Alto) and Stanford's cardiac surgery team, led by Norman Shumway, M.D. So, when I needed a cardiac diagnostic procedure and surgery I was faced with making a choice: a community cardiologist or a University Medical Center cardiologist. And then decide between a reputable community cardiac surgeon and team or surgery at the nearby University.

It was early July. Having served as a clinical faculty member myself at Stanford, Chief of Staff of a large local hospital and a member of a large hospital system board of trustees, I had enough experience and information to make the decision. I balanced the choice of a community hospital staffed by physicians and nurses who did complicated procedures well every day and the choice of going to a university medical center where I would be facing experienced faculty and a new crop of interns, residents and fellows. I stayed local and have never regretted that decision.

For information that might affect your decision in similar circumstances, see the Medline article and its related article which provides even more information. Be sure to discuss this issue with your trusted personal physician as you make your decision.

Complaint Day

2011-07-08T15:43:00.000-07:00

Years ago, when the San Jose, California area had GM and Ford automobile assembly plants, I would see patients who told me that they hated their auto assembly jobs. They said that they hated the work and the systems in which they were working. They hated having to spend their lives installing the right front tire on every vehicle that came down the assembly line. They hated their dehumanization (my interpretation, not their word), inability to make decisions and bring about change. They hated the imposed industrial metrics which governed their work and lives.

Now, I receive complaints about medical care from a variety of people throughout the country. Their themes reflect their perceptions that the people who provide their medical care have issues similar to the auto workers I described. I interpreted their experiences differently from the way they interpreted them. The common theme for them was failure to receive care, interest, attention and proper treatment. My interpretation focuses on two issues, business arrangements and professionalism which I believe underlie many of these complaints.

When a physician sends a patient off without taking an adequate history, without performing an appropriate physical examination, and without offering an evidence-based diagnosis and treatment plan, that physician is unprofessional and has not fulfilled his or her responsibility to the profession, to the people who have established a governmental licensing authority providing a franchise for that doctor to provide professional care, but most of all, to the patient who, with a mixture of anxiety and trust, has come to that physician for professional intelligence, wisdom, insight and understanding. Patients are defenseless against the professional's "brush off," lack of concern, lack of skill and lack of interest or distractedness. Unfortunately, for those physicians - and most of all for their patients - what should be an intellectually challenging and engaging work has become a 9-5 job.

Factors shaping the health care profession which affect providers, patients and payers, include the "businessification" of medical care. What was once a single-practitioner or small group practice, marked by strong identification with the quantity and quality of care provided to patients and pride in shared practice skills, now will often be a large multi-location multi-specialty group, operated or controlled by non-physicians, with standards for practice essentially set by highly-paid non-medical administrators and business personnel enforce those standards through highly paid and carefully placed (and controlled) medical administrators (i.e., directors and department chairpersons) . The financial bottom line offsets the real quality of care (not the advertised quality of care). The choice of ancillary staff, productivity per doctor, cost per square foot of space, equipment, range of services, and scheduling have been removed from physicians' decision-making. Marketing-oriented questionnaires substitute as measurements of quality. Return on investment, rather than life-changing high-quality of care, is the measure of effectiveness and efficiency. Your health care has moved into the industrial metrics and control era. It's not the government's fault. It's our fault.

Quality of care can be measured, but why should anyone bother? If an insurer has a new group of patients every year, why invest in care which may initially cost more, but save their competitors money when, in later years, they inherit the patients on the basis of their "low" insurance premium bid. If the physician's pay and recognition depends more on the amount of revenue generated than the actual quality of care he or she has provided to non-high-profile patients, the physicians become ground down, their professionalism suffers and they have neither time nor interest in dealing with your complex medical issues in a 10 minute time slot.

We know what happened to GM and Ford and previous GM and to the sad owners of their industrial-metric produced cars. What is going to happen to you and your family under the industrial approach to health care?

Harold and the Band

2011-07-05T13:40:00.000-07:00

Years ago, when I performed "pre-hire" physical exams at 7:30 Monday mornings, musicians were easy to spot. At one point during the exam I would hold a mechanical (tic toc) watch near patients' ears and ask what they ("they" were mostly men) heard.. Then I would rub my fingers together near their ears and repeat the question. If they didn't hear anything, my next questions were (1) are you a musician?and (2) did you have a gig this weekend? Invariably the answer was "yes" to both. Musicians were easy to spot because they were hearing impaired as a result of their work.

My friend, Harold, was not a musician. He was a caterer, and like many in that occupation, he provided fine food and competent service at bar mitzvahs, weddings and other large events where music was part of the entertainment. But unlike most caterers, Harold had something special in his pocket, something which was unusual. He carried a pair of wire snips.

When the music, became painfully loud, Harold would speak to the band leader and ask that the volume be reduced. The band leader usually complied - for a while. But because the band leader and the musicians were all hearing impaired and didn't appreciate what the party goers were hearing, soon the volume would rise again and Harold would wince. Once again, he told me, he would leave the serving tables and slowly walk to the band leader and ask that the sound volume be reduced. Once again, there was fleeting compliance. The third time, Harold made no request. He took out his wire snips, cut the musicians' amplifier wiring and walk away to a suddenly quiet banquet hall. The next time that Harold and that band leader were hired for another event, Harold never had to take the snips out of his pocket.

How many events have my readers attended which were marked by painfully loud music? I recently attended one at which there was a large glass container of soft earplugs (thoughtfully provided by the hosts) which were effective at protecting against the loud music played by the DJ, but also made it impossible to hold a conversation. How many of the young DJs, musicians, and their audiences, have impaired hearing as a result of irrationally loud music. How many of these people will require $5000 hearing aids later in life because no adult will take action, as Harold did?

Hearing loss is an isolating expensive handicap. Some of it can be prevented. Do we care enough about our young people to take action to protect them?

Radical, Revolutionary, and American

2011-07-01T19:57:00.000-07:00

America is a country in which the rights and welfare and health of all of its citizens have been paramount since its founding. We have significant responsibilities for ourselves, and to/for each other, and the attitude that some persons are not worthy of respect and health care is un-American, even when that attitude is manifested by a person elected or appointed to a federal office. Read on -

We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain inalienable rights, that among these are life, liberty and the pursuit of happiness.
......Declaration of Independence

We, the people of the United States, in order to form a more perfect union, establish justice, insure domestic tranquility, provide for the common defense, promote the general welfare, and secure the blessings of liberty to ourselves and our posterity, do ordain and establish a Constitution for the United States of America.
.....United States Constitution

In the future days which we seek to make secure, we look forward to a world founded upon four essential human freedoms: freedom of speech and expression, everywhere in the world; freedom of every person to worship God in his own way, everywhere in the world; freedom from want which will secure to every nation a healthy peacetime life for its inhabitants, everywhere in the world; freedom from fear, which means a world-wide reduction of armaments to such a point and in such a thorough fashion that no nation will be in a position to commit an act of physical agression against any neighbor, anywhere in the world.
.....Franklin Delano Roosevelt

Does High Fructose Corn Syrup Make You Socially Unacceptable?

2011-06-30T19:58:00.000-07:00

Thirty years ago, few people knew about lactase enzyme deficiency. Some knew that they developed diarrhea and gastrointestinal complaints if they drank milk or ate dairy products, but few knew that the normal state for humans is to be unable to digest lactose (milk sugar), and that a genetic mutation has allowed some people to drink milk without any lactose-related problems.

Just as some individuals may not be able to digest milk sugar because they lack a specific digestive enzyme, a few may have a rare condition, hereditary fructose intolerance, which leaves them unable to digest fructose, the sugar found in many fruits and in foods containing high fructose corn syrup as a sweetener. This relatively rare condition is serious and can lead to severe metabolic complications. A different, less serious, medical condition is fructose malabsorption "...in which the cells of the intestine cannot absorb fructose normally, leading to bloating, diarrhea or constipation, flatulence, and stomach pain. Fructose malabsorption is thought to affect approximately 40 percent of individuals in the Western hemisphere."

If you don't feel well when you consume those high-fructose drinks or snacks, it may not be your imagination. You might have a rare condition, hereditary fructose intolerance, or just be one of the 40% of our population who malabsorb fructose. The treatment is straight-forward: avoid high fructose foods.

If you are interested, see the National Institutes of Health publication, The Genetics Home Reference on hereditary fructose intolerance. You might learn that those pains in your belly, that gas that embarasses you, and your other strange abdominal complaints are related to that ubiquitous high fructose corn syrup sweetener, passed off as nutritionally benign, which might be causing you difficulty.

Read the food label. If you know that the ingredient listed doesn't agree with you, don't buy or eat the product. You will feel better and be more socially acceptable!

More About Cognition and Alzheimer's & Diet

2011-06-24T22:17:00.000-07:00

Two articles of interest.

Fran Lowry, writing in Medscape Medical News, reports Erin McGlade, Ph.D.'s findings that women (40-60 years old) taking 250 mg. a day of citicoline, a nutritional substance experienced better cognition and possibly mitigation of the decline in thinking that we consider an age-associated finding. Dr. McGlade is associated with the University. of Utah Brain Institute in Salt Lake City.

In another Medscape Medical News report, writer Megan Brooks reported on findings by Suzanne Craft, Ph.D. of the Veterans Affairs Puget Sound Health Care System, Seattle, WA. These findings point to a possible protective effect of the Mediterranean diet, not only on the cardiovascular system, but also on some biologic markers for Alzheimer's Disease.

There is increasing evidence for the important role of diet in brain and cardiovascular function. My readers might want to Google "Mediterranean Diet" and then use that information to guide their food intake. Preventing disease through a good-tasting healthy diet is more efficient and less expensive than dealing with vials of pills from your pharmacy plan. And, there's no copay or (literally) doughnut hole.

Will This Test For Early Alzheimers Explain Why Americans Have Forgotten?

2011-06-23T14:36:00.000-07:00

If you are thinking - what does he mean, "Americans Have Forgotten" -go back a few years, to a previous presidential administration driven by an ideology justifying the exhaustion of America's financial resources so there would be no money left for social programs. That administration wasted America's financial resources (in two ways, [1] through endless budgetary deficits created by reckless spending - i.e. - a several trillion dollar war in Iraq - coupled with reduction of taxes for the wealthy and [2] through deregulation of their political contribution supporting financial services industry leading to America's economic collapse and today's severe continuing recession). Now, its representatives who control the House of Representatives smugly claim that the other party is fiscally irresponsible as the party's President struggles out of the swamp we inherited from them.

If business is unhappy with the cost of social services including those mandated by the Affordable Care Act, it should look at what the party which professes to be its best friend did. Business has collapsed, employment has collapsed, the home building industry has collapsed and America is in a mess. Gee, wasn't that the exact consequence planned by the overseers of the ideology of destruction of our economy to complete their ideologic triumph? Or did you forget that?

If you want to know why you forgot what that party and its ideology have done to you and your families, to our health care system, and to America, you might go ahead and get the Alzheimer's test described in the article, or even better, you might be more thoughtful about casting your vote in the next election. That party is counting on you to forget again.

Think Of It This Way ....

2011-06-16T21:18:00.000-07:00

When I arrived at the lab, in this large new clinic building decorated with spectacular art work, it was 6:35 AM. Many of the chairs were filled and those that were empty were soon occupied by people waiting to be called for their tests. Six or seven people lined-up at the intermittently-staffed lab reception desk.

You might not recognize this as cost-shifting, but in my opinion, it is. Clinic management has decided that it is more efficient, in terms of their needs, to keep 18 people waiting for more than a half-hour each, rather than bring in phlebotomists to draw blood and instruct patients on how tests are to be performed. Those patients, waiting for their blood to be drawn and specimens to be taken, were not at work, were not earning wages, and had just used expensive cars and expensive gasoline so that they could sit and wait and wait and wait.

When government and insurance companies calculate the costs of care, rarely are patient transportation costs and lost opportunity costs (not being at work earning a living) added to the equation. Those dollars come out of the patients' pockets, not the government or insurers pockets. The cost has been shifted and no-one seems to notice or care.

So think of this as a cost shift and as an uncounted tax that each of us pays.

Cancer Anyone?

2011-06-13T20:51:00.000-07:00

I remember Frank, quite well. He was the cadaver that I and three other medical students dissected in our first year anatomy class. Frank reeked of formaldehyde, and I remember my allergic reaction to his fumes which required me to take an antihistamine so I could finish my daily assignments and take my tests. In those days, the most effective antihistamines were sedating, and it was a wonder that I ever passed any of the anatomy exams.

It turns out that my allergic reaction to Frank's preservative was the least of the problems. Formaldehyde is now listed as a potent carcinogen. To read more about formaldehyde and other carcinogens - which may have been or may be in your environment, read the 12th Report on Carcinogens. It will provide plenty for you to think about.

Do You Get What You Pay For?

2011-06-06T23:14:00.000-07:00

When I first practiced medicine, a visit with my internal medicine partners, was scheduled to last 20 minutes. During that $9 visit, our standard of care called for taking the patient's history, performing a significant physical examination - including looking at the skin, checking for enlarged lymph nodes, examining the heart, lungs, abdomen and breasts, performing a brief neurologic examination, and preparing a chart note which listed significant items and findings. Because there was continuity of care, with patients not changing insurers and doctors every year, we knew our patients well and recognized important changes in their histories or physical examinations. We noticed unusual moles and lumps and masses and though we did not have electronic records, computers, or the extraordinary array of lab tests now available, we had the standards, skill, time and interest to establish early life-saving diagnoses leading to curative treatment for many.

When patients visit their "primary care providers" now, there is neither time nor interest nor a standard of care supporting the performance of anything other than a "focused" examination. The patient is asked what the major reason for the visit is, and anything else is likely to receive not even cursory attention. Ask yourself - when did your doctor (or non-physician health care provider) last ask you whether you had noted any changes in a mole and actually had you remove sufficient clothing so that a skin examination could be done?

The June 6, 2011 New York Times front page features an article titled "Two New Drugs Show Promise In Slowing Advanced Melanoma" which describes two new drugs [also reported in the June 2, 2011 New England Journal of Medicine (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00019682)) which offer a short window of response to advanced melanoma skin cancer. The article is well written. But my readers, need to understand that if the melanoma had been found at an early stage in a routine office visit by a health care provider with sufficient professional standards, skill, time and interest to actually look at the patient sitting there on the examining table, that melanoma might have been diagnosed at an early curable stage when it would never require drastic new treatments with significant side effects which offer only short-term respite at enormous patient and societal cost.

So the next time you go to your doctor for a "focused" visit, ask that the doctor (or other provider) to spend enough time to actually look at your skin. Maybe this simple request will save your life.

The adherence to professional standards, professional skill, interest and willingness of my doctor during a recent visit, to look for, find and recommend treatment for my melanoma - hopefully - will save mine.

A Very Sick Nurse

2011-06-03T16:41:00.000-07:00

She was the sickest patient, who survived, that I can recall. A nurse in her 30s, barely able to move and to tell me about her medical condition that winter day. The thermometer that I placed under her tongue reported 108 degrees (in the "heatstroke" range), which is as high as those thermometers read. The physical exam showed nothing diagnostic except for neck stiffness. She looked as if she was going to die. I did a spinal tap (lumbar puncture) which suggested a viral infection of the nervous system. The diagnosis was confirmed by laboratory testing. A week later, after intensive supportive care, this nurse left the hospital, and a few weeks later she was back to work, recovered.

This was the picture of measles, a disease which killed a significant portion of the Native American population in the 1700 and 1800s. A diseases which vaccination now prevents - if mature adult judgment recognizes that parents are responsible for protecting their children from measles by having them vaccinated. It is irresponsible to withhold measles vaccination from a child who has no contraindications to vaccination. Bluntly: parents who love their kids protect them from serious infectious diseases by vaccinating them.

Read about measles and other diseases for which vaccination saves lives, prevents misery and saves health care dollars.. And make sure that your kids, and their friends and friends' friends, are vaccinated.*

My blogging has been intermittent because of personal health issues. I hope to get back to my schedule of two to three times a week. Stay well!

*Link added July 3, 2011

Kids Drown

2011-05-24T22:38:00.000-07:00

One of my former partners, an extraordinarily competent internist, saved a drowned child's life by resuscitating him in the hospital emergency room. Another doctor, in the same city, lost his adolescent twin sons when they drowned in the backyard family swimming pool.

Kids drown. And when they do, it means that an opportunity to save their lives through the exercise of simple adult responsibility, was not taken. Don't let it happen to you or a member of your family or friends's kids or even a neighborhood child who has obtained access to your pool You are the responsible adult and you must act responsibly.

No children, including adolescents, should be in a pool without adult supervision.Children do not have adult judgment and they do dumb dangerous childish things: they need adult supervision.

At a party, where adults and children are swimming, the host or hostess should clearly and unequivocally and repeatedly explain that it is each parent's' responsibility to watch his or her own child and be responsible for the safety of that child. It isn't the host's responsibility, It isn't the responsibility of other parents to watch your child or of you to watch their children swimming. It isn't the responsibility of a young adolescent acting as a lifeguard. If you can't be bothered to watch your own child in the pool, get the child out of the water and to a place where he or she will be safe. And then make sure that he or she stays out of the water, regardless of the taunts of invitations of other kids.

Pay attention. Have a cell phone available, but don't use it to text or chat, or respond to calls, because you will be distracted and unlikely to be paying attention to your child. Know the address of the house or place where the kids are swimming because in an emergency, that information may save a few precious seconds. Alcohol-containing drinks will probably interfere with your ability to respond to an emergency: save the drinking for another time and place.

Adults should enforce routine safety around swimming pools, stopping potentially dangerous horseplay or behaviors which may result in injury. Don't apologize to the kids (or their parents) who complain about restrictions on dangerous behavior: explain that you are serious about the safety rules you are enforcing.

Read the material in the links above because that information may save a child's life, save you from a lifetime of anguish, and save you from financial ruin.

Take the risk of drowning in a family pool seriously. Be a responsible and caring adult.

Social Media: Preparedness 101: Zombie Apocalypse

2011-05-19T14:59:00.000-07:00

Are you zombie ready? Check out this CDC disaster preparedness article and, as it says, be safe rather than sorry. And be sure that your friends and family are prepared, too, otherwise your failure to share may leave them as zombie bait.

Food Safety: Safer Food Saves Lives, Suffering and Health Care Costs

2011-05-13T13:04:00.000-07:00

Savings under Health Reform involve more than making health care more available, affordable/ accessible, and competent. One way to save money is to protect Americans from everyday hazards that make them sick - including our food.

We are sickened by our food. The CDC estimates that foodborne diseases "...cause approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States each year. Known pathogens account for an estimated 14 million illnesses, 60,000 hospitalizations, and 1,800 deaths." While unsafe manufacturers and food handling processors profit from their carelessness, Americans of all ages suffer and die. The public shoulders the considerable cost shift from dangerous operators in the food industry to America's families..

The Obama administration has begun the process of safeguarding our families by modernizing our food safety laws, taking steps to implement hazard analysis and risk-based preventive controls, establish safety and performance standards, provide for safe transportation of our food, provide for safe importing of food from abroad, update government's ability to recall suspect food products, and taking other overdue major steps.

Protecting our families by protecting and safeguarding our food supply makes good sense. Protecting outr health care budget by protecting and safeguarding our food supply makes good sense, too Let's be sure that our Congressmen and Congresswomen don't through up roadblocks to this important change.

Scientific American: Motion Suppresses Some Of Our Brain Function

2011-05-12T11:13:00.000-07:00

Ever wonder why your friends/family/colleagues don't notice changes? See the Scientific American blog for insight.

Diabetes: Beware of Your Glucose Meter Control Solution

2011-05-10T14:45:00.000-07:00

Today, I received a call from a reputable medical supply distributor's quality assurance person in response to a letter I sent complaining that their brand of control solution for a nationally distributed brand of glucose meters and test strips gave lower values than the name brand manufacturer's control solution. While this might seem like a minimal technical issue, it has practical implications for patients who work hard (and shed blood in the process) to maintain "diabetes control" - by keeping their blood sugar within specific ranges. Too high, and kidney, visual and neurologic problems may develop; too low and the patients may suffer strokes or pass out. When patients and their physicians cannot easily tell whether glucose meters are accurate, or how inaccurate they are, trouble follows.

The conversation led me to conclude that the company was not communicating well with its customers and lettering them know up front, clearly and unequivocally that there was a problem with its control solution. Someone in the company had made the decision to obfuscate and should take public responsibility. Meanwhile, patients, physicians, Medicare (as a payer) and the FDA should ask: what is going on here? Diabetes is a common, potentially fatal and incapacitating disease which costs patients, insurers and the federal and state governments billions of dollars each year. Let's get the diabetes glucose monitor control solution issue resolved.

Presidential Election: How Will The Health Care Uninsured Vote?

2011-05-09T12:04:00.000-07:00

In my last blog, I provided a link to information about the number of US persons who have no health insurance. The statistics show that almost 50 million Americans do not have health insurance. My question - which is not answered in my brief Google searches - is "how will the health care uninsured vote?"

If anyone has evidence-based insight into this issue, please speak up.

NO HEALTH INSURANCE? - YOU ARE NOT ALONE.

2011-05-06T13:49:00.000-07:00

HOW MANY AMERICANS DON'T HAVE HEALTH INSURANCE?
Read this and check the link to find out!

Health Insurance Coverage: Early Release of Estimates From the National Health Interview Survey, January–September 2010

Highlights
From January through September 2010, 49.5 million persons of all ages (16.3%) were uninsured at the time of interview, 60.8 million (20.0%) had been uninsured for at least part of the year prior to interview, and 36.1 million (11.9%) had been uninsured for more than a year at the time of interview.
From January through September 2010, the percentage of children under age 18 years who were uninsured at the time of interview was 8.2%.
Private coverage decreased among near poor adults aged 18–64 years, from 52.6% in 1997 to 34.6% in the first 9 months of 2010. The uninsured rate (43.9%) is higher than the private coverage rate (34.6%) for this population.
From January through September 2010, 59.1% of unemployed adults aged 18–64 years and 23.5% of employed adults in this age group had been uninsured for at least part of the past year. Also, 36.4% of unemployed adults aged 18–64 and 15.0% of employed adults in this age group had been uninsured for more than a year.
During the first 9 months of 2010, 24.9% of persons under age 65 years with private health insurance at the time of interview were enrolled in a high deductible health plan (HDHP), including 7.4% who were enrolled in a consumer-directed health plan (CDHP). Almost 50% of persons with a private plan obtained by means other than through employment were enrolled in a HDHP. An estimated 20.0% of persons with private health insurance were in a family with a flexible spending account (FSA) for medical expenses.

Voluntary Coumadin Recall

2011-05-03T22:40:00.000-07:00

http://www.fda.gov/Safety/Recalls/ucm253523.htm :
Bristol-Myers Squibb Initiates a Nationwide Voluntary Recall of Coumadin® (Warfarin Sodium) Crystalline 5 mg Tablets, Lot Number 9H49374A

When I clinically practiced as an hematologist, I dealt with a variety of anticoagulants, both as an initiator of treatment and as a consultant called when things went wrong. I have seen anticoagulants, such as warfarin (trade name - "Coumadin") and heparin (and its derivatives) save lives, and I have seen them cause severe bleeding (and other) complications including death. In practice, I constantly kept in mind the 2% case-fatality rate associated with warfarin and the particular risk that was seen in frail elderly women for whom it was prescribed.

The indications for warfarin treatment usually involved the formation of blood clots in the venous system and the risk that a clot would dislodge, travel to the lungs as a pulmonary embolism, and cause death or severe lung damage. At Stanford, I trained with hematologist Professor Edward Hershgold, who taught us great respect for warfarin, expounding on accumulated clinical research with this drug, and drilling us on its ability to induce anticoagulation slowly (over 7-10 days), sometimes when laboratory tests suggested that it had more quickly achieved its intended effect.

In my consultant practice, I saw the dark side of warfarin when physicians who used warfarin infrequently did not carefully and fully educate their patients on the proper use of warfarin, dietary management, the risks of drug interactions with medications commonly prescribed by physicians, and the requirement for frequent laboratory testing of the"prothrombin time" and "INR" in following the appropriateness of the anticoagulation level achieved. In our health law practice, we saw physicians charged with being inconsistent in testing their patients for anticoagulation and then properly communicating with their patients about the results of their tests and prescribing instructions, sometimes with serious adverse consequences which endangered their medical licenses.

With all of those considerations in mind, I highlight a voluntary Coumadin recall of one lot of Coumadin by its manufacturer Bristol-Myers Squibb as as a precautionary measure based on the company’s testing of tablets from a returned bottle. A single tablet was found to be higher in potency than expected.

If any of my readers take Coumadin or have friends or family taking Coumadin, I suggest that they refer to the link to the FDA release and follow the recommendations in that FDA release. For those who require anticoagulation, the dose (generic or brand name) must be just right, not too high or too low.

FOR IMMEDIATE RELEASE - May 2, 2011 - Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin® (warfarin sodium) Crystalline 5 mg tablets. Bottles of 1,000 tablets are distributed to pharmacies for further dispensing to patients in prescription quantities. The lot number affected in the U.S. is 9H49374A with an expiry date of September 30, 2012. The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle. A single tablet was found to be higher in potency than expected.

Coumadin is prescribed to treat or prevent blood clots. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke and if there is too much active ingredient, there is an increased risk of bleeding.

Patients who may have 5 mg tablets should not interrupt their therapy but should seek advice from their pharmacist to see if they have tablets originating from the affected lot and if so, should consult their physician for appropriate medical advice.

Bristol-Myers Squibb is committed to ensuring patient safety and is working to resolve this issue quickly and appropriately. The company has notified the U.S. Food and Drug Administration (FDA), and will issue recall communications to all physicians and other customers involved.

Any adverse reactions may be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov.

Health care professionals and customers may call the following for assistance if they have further questions about the recall:

For information related to this recall:
Stericycle, Inc.
1-866-918-8739

HHS SAYS: TASTES GOOD AND IS GOOD FOR YOU!

2011-04-19T17:18:00.000-07:00

WOW - good news for all except chocolate Easter bunnies.

Eric Ding, a Harvard School of Public Health epidemiologist, reports that Flavonoids are antioxidants, commonly found in fruits and vegetables. A systematic review and pooling of randomized trials found that consumption of cocoa rich in flavonoids (i.e., dark chocolate) may improve risk factors for heart disease and diabetes.

The release states that “Higher cocoa flavonoid consumption reduced systolic blood pressure, reduced LDL cholesterol, the bad cholesterol, increased HDL cholesterol, the good cholesterol.”

The 72 Cent Dollar

2011-04-15T16:17:00.000-07:00

Suppose someone on the street corner made you a proposition. He would give you 72 cents for every dollar in your pocket. What would you think? What would you say? What would you do?

So when Mr Ryan offers to privatize Medicare, which means that between 25 and 30 cents of each dollar would be used by the insurers for administrative overhead (which includes millions in executive salaries) what do you think. What do you say. What are you going to do?

When I last checked, Medicare's administrative overhead was about 3 cents on a dollar. That sounds like a much better deal for you than privatization. But it just isn't as good a deal for political campaign funds- which may be why the proposal has been floated. Make your thoughts known to the people who act as if the rest of us are stupid.

ACCOUNTABLE CARE ORGANIZATIONS (ACOs)

2011-04-08T11:45:00.000-07:00

THIS REQUIRES YOUR ATTENTION and COMMENT

The DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid
Services, has published its proposed rule (19528 Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Proposed Rules) which would implement section 3022 of the Affordable Care Act which contains provisions relating to Medicare payments to providers of services and suppliers participating in Accountable Care Organizations (ACOs). Under these provisions, providers of services and suppliers can continue to receive traditional Medicare fee-for-service payments under Parts A and B, and be eligible for additional payments based on meeting specified quality and savings requirements.

This long complex document (127 pages) will have a profound effect on quality, access to, and the cost of health care for all Americans. If the only commentators are hospital systems, physician groups, trade organizations, financial interests, lawyers and others whose economic interests will be served through having their input adopted, your family's and community's interests will not be well served.

Read it. Discuss it. Submit comments. Be heard. Or don't complain when your family's health care needs are subverted by other interests which focus on cost, profit and system control.

Playing Both Ends Against The Middle

2011-04-06T22:10:00.000-07:00

America's older population seem to present a problem for one political party. After all, our older citizens no longer work to produce taxes which Congress can spend on pork or the military-industrial complex. Seniors vote. Seniors occupy housing which real estate interests might prefer to sell or rent to younger, employed and more affluent working people. The elderly soak up Social Security and Medicare and Medicaid dollars as they live longer and demand the care and help (for which they long paid taxes) promised to them by a series of presidents dating back to FDR. The elderly are experienced and smart enough to doubt the nonsense that politicians shovel their way and clearly express their disbelief. And some seniors, reaching the ancient age of 50+ refuse to get out of the way so that employers can plug fresh faced 29 year olds into their jobs using their "fresh blood" to reduce employment health insurance and other costs, raising corporate profits so that executives get the bonuses that might otherwise be paid to older shareholders in the form of dividends. As that political party looks at the subsidies that the elderly require it points a finger and shouts - "you are bankrupting us!"

And the very young are a a problem, too. They have to be fed, clothed, housed and educated before they can join the military in Iraq (or some other country involved in America's wars) or unsuccessfully seek employment in an economy which has been butchered by the financial services and other industries. Some of the young actually have a continuing need for health care, requiring the federal government and states to ante-up for subsidized payments through Medicaid. The political party that points to the financial burden of the elderly, unflinchingly demand that the health care needs of the young and their families should not be America's responsibility, it should be the sole burden of the young and their families. If their families are unable to shoulder that burden because they are "not worthy" they should not be able to discharge their debts in federal bankruptcy.

But the middle - where corporate America and other major political party donors reside - there are no problems at all that a further tax cut cannot ameliorate. In the middle, inventive financial interests are exercised to produce virtual markets which sell products that no-one understands, sees, or can explain. Jobs are shipped overseas to nations that provide little or no health benefits to their workers. That same political party that objects to subsidizing the cost of health care and social support for the young and the elderly have no problem at all in providing its big-business financial supporters with large tax subsidies which cost-shifts health and social expenses from the most able to pay to those who do not have the resources to pay.

Playing both ends against the middle is an old game. Is our public smart enough to realize that no person or family is immune to the ravages of these tactics? If they "do it" to older Americans, some day all who are now young will suffer. If they do it to young Americans and their families, the young and their families will suffer and their elderly parents will deplete their savings to help them. And if corporations continue to be highly subsidized though America's tax code, we will all suffer and our health system will disintegrate. Except for those wealthy enough to be able to take care of themselves and support the political party which deems them "worthy".

Agag

2011-03-27T21:27:00.000-07:00

Agag and the Amelekites are not common household subjects of discussion, but there is a lesson to be learned from their biblical history. Agag was the title of Amalek king(s) and his people, the Amelekites picked off, robbed and murdered the elderly, infirm, and weak stragglers among the Israelites. For their ruthlessness, cruelty and haughtiness, the Amelekites - in turn - were later slaughtered.by the Israelites.

The lesson taught with respect to the Amelekites has application to our health system. As insurers, health systems and providers abandon their responsibility to care for the elderly, infirm, weak and those who cannot defend themselves, they may provoke society to punish them (and those who accept their support in order to fund their election campaigns) for their ruthlessness, greed, cynicism, arrogance and cruelty.

Have we created our medical schools, licensed our practitioners, created non-profit health systems, provided franchises for insurance companies, and subsidized all of these institutions so that an injured person who is brought to a hospital emergency department writhing in pain may be told by the physician consultant called by the ER that he will not render care to this unfortunate person because he doesn't accept that person's insurance? Is Agag still walking among us and setting the standards for our health system?

Sorry,But

2011-03-25T21:30:00.000-07:00

A serious family medical event has taken priority over the blog "Our Health System."

Should Teachers Get War Zone Pay?

2011-03-16T11:55:00.000-07:00

I will start with a warning: a number of years ago, a family member was a teacher in a New York "fortress" primary school. Watching that family member's experience (I have taught at the university and post-graduate level and in my experience, that does not involve comparable stress exposure), I concluded that some classrooms expose teachers to extraordinarily and unreasonably high levels of stress.

In a recent blog, I described the findings by a Nobel award-winning scientist, that telomere length is a critical factor in cellular health (particularly among women) and that stress is a common factor believed to shorten telomere length. Is someone willing to study telomere length among teachers in high stress level classrooms, demonstrate whether the telomeres are statistically significantly shortened (compared to a control group), and if they are, propose a fair compensation system for teachers' classroom battlefield physical damage? Does anyone really want to know the answer to those questions and then have to deal with the consequences?

60 Minutes - Softball Questions About Counterfeit Drugs

2011-03-13T23:13:00.000-07:00

If you listened to the 3/13/2011 CBS' 60 Minutes' interview with the FDA Commission about counterfeit drugs, you didn't hear the difficult question, the real question, as to the difficulty that the FDA has with pharmaceutical product manufacturing and counterfeiting abroad. Had the question been asked, perhaps the FDA Commissioner would have acknowledged that the FDA is not given sufficient money through the Congressional budgeting process to supply the systems and hire the people to take frequent hard looks abroad for shoddy pharmaceutical manufacturing processes and counterfeiters. Those who provide our Representatives and Senators with campaign funds do not want a strong FDA regulatory process, notwithstanding that FDA regulation is a matter of life preservation for many Americans. They would rather provide election financing, pay the small fines, hire the law firms to defend themselves and let the counterfeiters skim off some of their profits. They are unconcerned with Americans' welfare; they are concerned with corporate profits and executive bonuses.

60 Minutes: why aren't you addressing the significant issues?

Health Care in America: What Would Jonathan Swift Have Done?

2011-03-09T11:38:00.000-08:00

After observing Washington, D.C. and state capital railings and political warfare against reforming American health care, I turned to Jonathan Swift for perspective. My readers might find his insights disturbing, familiar, and insightful. Remember, though, Gulliver's Travels and his other works (available free) are were not written for young children.

YOUR SPOUSE HAS CARDIAC ARREST - WHAT THEN?

2011-02-28T18:12:00.000-08:00

At a meeting a few days ago, I brought along the January 27, 2011 New England Journal of Medicine article by Gust H. Bardy, M.D. "A Critic's Assessment of Our Approach to Cardiac Arrest." Since NEJM is copyright protected, I gave the original article serially to several health care professionals.

Bardy observed that success with home automated external defibrillators wasn't as good as the experience when they are used in public places and posits that the sudden collapse of a spouse may be associated with a delay in the ability of the survivor to call for help, which accounts for the disparity.

On reading the article, one of the doctors asked "why doesn't the home AED automatically call 911 and provide an alert and address when it is removed from its holder?"

If there is an AED expert among my readers, please answer the doctor's question (I will publish the answers) so that we may improve the likelihood of recovery from home cardiac arrest. Are there cost, technical, bureaucratic or other barriers to this solution?

Another Privacy Rights Violation Results In a Large Financial Settlement

2011-02-24T20:08:00.000-08:00

Once again, the Office of Civil Rights has gone after health care privacy violations, though this time, a well known institution, Mass General and its physicians were the target. Here is the entire notice provided to me by OCR.

Massachusetts General Hospital settles potential HIPAA violations

February 24, 2011

The General Hospital Corporation and Massachusetts General Physicians Organization, Inc. (Mass General) has agreed to pay the U.S. government $1,000,000 to settle potential violations of the HIPAA Privacy Rule.

Mass General, one of the nation’s oldest and largest hospitals, signed a Resolution Agreement with HHS that requires it to develop and implement a comprehensive set of policies and procedures to safeguard the privacy of its patients. The settlement follows an extensive investigation by OCR.

“We hope the health care industry will take a close look at this agreement and recognize that OCR is serious about HIPAA enforcement. It is a covered entity’s responsibility to protect its patients’ health information,” said OCR Director Georgina Verdugo.

The incident giving rise to the agreement involved the loss of protected health information (PHI) of 192 patients of Mass General’s Infectious Disease Associates outpatient practice, including patients with HIV/AIDS. OCR opened its investigation of Mass General after a complaint was filed by a patient whose PHI was lost on March 9, 2009. OCR’s investigation indicated that Mass General failed to implement reasonable, appropriate safeguards to protect the privacy of PHI when removed from Mass General’s premises and impermissibly disclosed PHI potentially violating provisions of the HIPAA Privacy Rule.

This impermissible disclosure involved the loss of documents consisting of a patient schedule containing names and medical record numbers for a group of 192 patients, and billing encounter forms containing the name, date of birth, medical record number, health insurer and policy number, diagnosis and name of providers for 66 of those patients. These documents were lost on March 9, 2009, when a Mass General employee, while commuting to work, left the documents on the subway train. The documents were never recovered.

“To avoid enforcement penalties, covered entities must ensure they are always in compliance with the HIPAA Privacy and Security Rules,” said Verdugo. “A robust compliance program includes employee training, vigilant implementation of policies and procedures, regular internal audits, and a prompt action plan to respond to incidents.”

If you believe that a person or organization covered by the Privacy and Security Rules has violated your health information privacy rights or otherwise violated the Privacy or Security Rules, you may file a complaint with OCR at http://www.hhs.gov/ocr/privacy/hipaa/complaints/index.html.

Read the HHS Press Release Read the Resolution Agreement and CAP

Additional information about OCR’s enforcement activities can be found at www.hhs.gov/ocr.

What Is The Cost of Violating Patient Right To Records Rule ?

2011-02-23T10:23:00.000-08:00

I have received this notice, posted by the federal Office of Civil Rights, and reproduced it in its entirety. See link:

Click for the Washington Post article on this situation.

HHS Imposes a $4.3 Million Civil Money Penalty for Violations of the HIPAA Privacy Rule

February 22, 2011

OCR has issued a Notice of Final Determination finding that Cignet Health of Prince George’s County, Md., (Cignet) violated the Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). HHS has imposed a civil money penalty (CMP) of $4.3 million for the violations, representing the first CMP issued by the Department for a covered entity’s violations of the HIPAA Privacy Rule. The CMP is based on the violation categories and increased penalty amounts authorized by Section 13410(d) of the Health Information Technology for Economic and Clinical Health (HITECH) Act.

“Ensuring that Americans’ health information privacy is protected is vital to our health care system and a priority of this Administration. The U.S. Department of Health and Human Services is serious about enforcing individual rights guaranteed by the HIPAA Privacy Rule,” said HHS Secretary Kathleen Sebelius.

In a Notice of Proposed Determination issued Oct. 20, 2010, OCR found that Cignet violated 41 patients’ rights by denying them access to their medical records when requested between September 2008 and October 2009. These patients individually filed complaints with OCR, initiating investigations of each complaint. The HIPAA Privacy Rule requires that a covered entity provide a patient with a copy of their medical records within 30 (and no later than 60) days of the patient’s request. The CMP for these violations is $1.3 million.

During the investigations, Cignet refused to respond to OCR’s demands to produce the records. Additionally, Cignet failed to cooperate with OCR’s investigations of the complaints and produce the records in response to OCR’s subpoena. OCR filed a petition to enforce its subpoena in United States District Court and obtained a default judgment against Cignet on March 30, 2010. On April 7, 2010, Cignet produced the medical records to OCR, but otherwise made no efforts to resolve the complaints through informal means.

OCR also found that Cignet failed to cooperate with OCR’s investigations on a continuing daily basis from March 17, 2009, to April 7, 2010, and that the failure to cooperate was due to Cignet’s willful neglect to comply with the Privacy Rule. Covered entities are required under law to cooperate with the Department’s investigations. The CMP for these violations is $3 million.

“Covered entities and business associates must uphold their responsibility to provide patients with access to their medical records, and adhere closely to all of HIPAA’s requirements,” said OCR Director Georgina Verdugo. “The U.S. Department of Health and Human Services will continue to investigate and take action against those organizations that knowingly disregard their obligations under these rules.”

A copy of the Notice of Final Determination and Notice of Proposed Determination may be found at http://www.hhs.gov/ocr/privacy/hipaa/news/cignetnews.html.

The Perfect Storm?

2011-02-21T21:06:00.000-08:00

As a person who practiced hematology, I learned to ask a few questions early in my career and early in my physician-patient relationships: what kind of work do you do now and what kind of work have you done? Where do you live now and where did you live before moving to your current location? Do you have any occasion to handle toxic materials at work or in your personal life. Do you live down-wind from a refinery? When you were in the armed services, did you come into contact with toxic materials, including radiation and chemical warfare or biologic materials? Tell me about your hobbies, and specifically whether you are exposed to wood dust or fine shavings?. Tell me about your use of alcoholic beverages, drugs and other substances. Tell me about your smoking history.

While all of this may be interesting to my readers, few probably think that it is relevant to them, but environmental toxic exposures play a major role in causing disease. You may keep your weight under control, be careful about taking saturated fats, never pick up a salt shaker and exercise regularly, but if you are exposed to toxic substances in your environment, in your food and in your home, you may develop leukemia, cancers (bladder, lung, skin, testicles and others), black lung disease, serious infections, emphysema, brain disorders, and a host of other disabling, fatal and expensive-to-treat diseases. And if we allow our children to have those exposures, they are also at risk.

All of which, at a time when the country is working desperately to control its health care costs, makes me wonder why any political party would seek to weaken our environmental laws. Does it make sense to try to roll-back health reform and simultaneously roll back the environmental protections which America - with much effort - has invoked to protect its children, men and women? Has this become a country in which we cannot trust one another to take reasonable care of our children, workers and vulnerable citizens? Is the tension between financial interest and the well-being of our citizens always to be resolved in favor of financial interests?

Be Generous To Your Supporters and Evil To Your Enemies

2011-02-10T23:21:00.000-08:00

The practical rules of politics haven't changed since the days of Plato. As we watch the revolution in Egypt, we understand that those rules are as alive today as ever. The problem for our Congresspeople, with respect to health care, is to determine who are their supporters and who are their enemies.

If you want to know who financially supports your Congressperson, call that person's office and ask. Or search online. In either case, you will only find part of the answer since direct financial payments to Congresspersons' campaign funds, amounting to a few million dollars here or there for strategic Congress operators, is only part of the story. The other part - much more difficult to calculate - comes from individuals and groups who provide funding which gives them extraordinary access to your elected officials. Those Congressional votes aren't bought, but access is, and with access comes only one side of the argument about health care reform.

The tougher part is figuring out "who is your Congressperson's enemy"? Is it the kids who, if health reform were to be repealed, would lose their health insurance, lose their access to medical care, lose their medical care and treatments and get sick enough to die or become permanently injured. Is it the people who should be paying for their own health insurance, but prefer to use resources which other people pay for in the form of taxes and exaggerated medical costs - and go through life cost-shifting? Is it the well-paid health insurance executives? Is it the pregnant women who can't get health insurance? Is it the laid-off workers whose employers have cut-off their access to health insurance benefits? Is it the Medicaid patients whose states have run out of money to treat their leukemias, cancers, heart disease, diabetes?

So who are the politicians' supporters who play the music that certain segments of Congress dance to, and who are the politicians' enemies who "deserve" to be dealt evil? Who shall live and prosper and who shall be denied health insurance and die? Who deserves just treatment and who does not? What are the ethical rules governing political votes on health care reform?

When Johnny Comes Marching Home Again - Then What? The intersection of Science and Public Policy

2011-02-06T22:45:00.000-08:00

President Obama's promise to draw down forces in Iraq is in the process of being fulfilled. But only some of America's soldiers, marines, sailors and air force men and women make it home. Others are reassigned, this time to Afghanistan, about which a more opaque vision of troop withdrawal is dangled before us. Our all-volunteer forces continue their exposure to extraordinary stressors which severely try even the most even-tempered, fit and well-balanced men and women.

And then we see stories about, and pictures of, troops on duty, surrounded by their enemies who are sworn to (and do) kill and maim them, suddenly brought to the United States again. And other stories, about their family problems, suicides, drug use, problems with the law, post traumatic stress disorder and our government's promise - once again - to take care of our wounded warriors "better this time" without convincing evidence that the promise will be kept. In the 20th and 21st centuries we have seen budgetary constraints, long-term disability costs, the military need to return its troops to duty rather than acknowledge their need for withdrawal from combat, and an unwillingness to face the truth about the effects of wartime stresses on the men and women who serve America determine our policy about caring for returning military.

As described in my last blog, there is a new scientific tool which might help our government distinguish the men and women who are most at risk of damage from the stress of wartime service, and who are damaged by their experiences. My question is: will our military carefully study and then appropriately utilize existing and developing telomere research as one (of several) screening tools before and after sending people into combat to determine who is at risk and who has been injured by service?

There is a very real risk: that sending people to war in Iraq, Afghanistan and other far-flung posts, will invariably lead to serious stress-related damage to their chromosomes and be associated with destruction of their families, suicides, drug use, problems with the law and post traumatic stress disorder. Who would be willing to volunteer for military duty then? What family would approve of that service? What citizenry would then vote in favor of a war in far-off places?

Does It All Come Down To This? You Are Stuck With Your Genes, But Can Do Something About Telomere Length

2011-02-03T14:28:00.000-08:00

Last night's "Gerald and Sally DeNardo Lectureship" at Santa Clara University featured the University of California at San Francisco's Elizabeth Blackburn, Ph.D., 2009 Nobel Prize winner in the Physiology of Medicine. Speaking about telomeres, of which you, the reader have billions (2 per chromosome, 23 pairs of chromosomes per cell and more than 100,000,000,000 cells in your body), Professor Blackburn likened the full-length telomere to the intact tip of a ribbon shoelace, a structure which prevents unraveling and destruction.

Blackburn's research has disclosed that certain unicellular organisms, when undisturbed, have built-in systems for preserving the length of each telomere through multiple cell divisions but that laboratory interference with that length-preservation results in shortened cell life (loss of immortality). Going further, she and other scientists have discovered cellular mechanisms for preserving the length of the telomeres and scientific means for interfering with those cellular mechanisms.

People are not unicellular organisms living in Walden Pond, but Blackburn's discoveries have also demonstrated that peoples' lifetime events which result in shortened telomeres lead to the ability to predict life-shortening diseases including cardiovascular disease and diabetes. The events are not genetic, as much as environmental and the good news is that some of them are under society's and our individual control. The bad news is that our population has not had convincing serious long-term commitment to doing things which stabilize or lengthen telomeres, improve our resistance to diseases, lengthen lives and reduce the cost of health care.

Blackburn cited adverse childhood events, chronic stress (including adult post traumatic stress disorder, pessimism and, in men, hostility) as factors which she can associate with telomere-shortening and a corresponding poor survival prognosis. Stabilization and perhaps lengthening of telomeres is associated with increasing education, exercise and stress reduction.

So turn off the television, get off your rear end, take a pleasant walk, find sensible methods to relieve your stresses and stabilize (and lengthen?) your telomeres. It is likely that these simple acts will help you to live better and longer! You can also stop blaming your parents for the "bad" genes they gave you since most of your health problems may stem from your own habits and environment.

Who Will Fill The Ethical Void?

2011-01-31T21:29:00.000-08:00

We have heard the substantially different demands articulated by spokespersons from each major national political party concerning health reform, and today we heard that two federal courts have said that the Patient Protection and Affordable Care Act of 2010 is constitutional and two have declared it unconstitutional, moving the ACA in the direction of America's highest court which will be asked to offer a raised or lowered thumb.

In my earlier blogs, I asked the Democratic administration for a simple explanation of its ethical basis for moving ahead with health care reform. Neither I, nor - more importantly - the American electorate, received an answer. So now, it's the Republican party's turn: what is the ethical foundation for the Republican party's opposition to health care reform?

I can't figure out whether what is at stake is pragmatic politics, a sophisticated view of the health care needs of America's men, women and children, a greater respect for material wealth than human values, or exactly what each political party's ethical standards are. Where we are going? What are the points on the ethical compass we are being told to follow?

Will someone from the Republican party fill the void left by the Democrats? What are the ethical considerations of the Republican party in formulating its opposition to health care reform?

Dementia-Impaired Physicians

2011-01-25T14:32:00.000-08:00

Today I received confirmation that my chapter dealing with HIV-infected health care workers, in Thompson-Reuters' Health Law Guide (a near- encyclopedic publication for attorneys), has been forwarded to the publisher. In that chapter, I describe the low risk of blood borne HIV infection transmission from health professional to patient, or from patient to health professional, but the unquantified risk of judgment deficiencies in AIDS-dementia affected health care professionals in practice. The term "unquantified" indicates that I have not been able to determine the number of professionals who have the condition, the measurable effect of that deficiency on that population's judgment, or its consequences for patients.

Today's New York Times features a thoughtful article about aging physicians with dementia, a troubling subject which deserves attention (not just for physicians, but for those in other professions, as well). These demented physicians may go unnoticed and unreported by their colleagues and noticed, but not necessarily dealt-with by family members and others who are emotionally and economically related to them.

My only significant point of disagreement with the Times article is that periodic neuropsychological testing should be more frequently used by credentialing bodies to evaluate physicians' and other health (and non-health) professionals ability to practice safely. Use of testing would protect not only patients, but the professionals whose judgments and learning capacities are impaired, and thus prevent calamities and tragedies for both groups.

As one who has had the experience of a quiet conversation with a professional, telling him(or her) that the time has come to retire to protect patients and himself from deterioration in his judgment and skills, and then been thanked by the practitioner and (separately) his family for doing so, I know that it can be done.

If A Little X-Ray Is Good For You, Is More Better?

2011-01-18T19:50:00.000-08:00

A recent airport visit and and article on an online medical service, prompted me to recall a superb lecture at an American Society of Hematology Annual Meeting several years ago and the nagging question with which I left the hall. The subject was the biologic effect of radiation and the speaker scientist guided his audience through the intricacies of cellular responses to radiation, making the point that cellular repair systems spring into action within 10 seconds of exposure and may remain activated. And then he said something disconcerting, to the effect that he had been impressed with the interest of certain officials involved in the American defense system, in upping the exposure of Americans to radiation with the expectation that this exposure would augment their bodies' "resistance" to further radiation. The idea struck me as bizarre, since I and generations of physicians had been taught that there is no safe dose of radiation, and that with each increase in exposure, the frequency of mutations (with increased risk of cancer) increases. But then at the airport was this machine, supposedly in the interest of preventing terrorism, radiating a portion of the population . . . Oh really?

Added April 6, 2011: Drugs for treatment of radiation exposure.

HHS - Psychotherapy Notes and Testing Data Study Announcement

2011-01-12T19:55:00.000-08:00

NOTE: FOLLOW All of the instructions below to register

HHS to Host Webinar as Part of Psychotherapy Notes and Testing Data Study under the HITECH Act

January 12, 2011

The Substance Abuse and Mental Health Services Administration (SAMHSA) is conducting a Confidentiality and Privacy Issues Related to Psychological Testing Data study, in close cooperation with the Office for Civil Rights (OCR) pursuant to section 13424 of the Health Information Technology for Economic and Clinical Health (HITECH) Act, a component of the American Recovery and Reinvestment Act (ARRA) (P.L. 111-5). This study is addressing whether the HIPAA Privacy Rule’s special protections relating to the use and disclosure of psychotherapy notes should also be applied to “test data that is related to direct responses, scores, items, forms, protocols, manuals or other materials that are part of a mental health evaluation.”

As part of this study, SAMHSA is hosting an interactive webinar on January 18, 2011, 12:00pm – 2:00pm (EST), to bring together professionals in the areas of mental health and privacy protection, summarize what its project team has learned to date, and provide participants with opportunities to ask questions and submit comments.

Pre-registration is requested and can be accomplished at the following website: https://www.mymeetings.com/emeet/rsvp/index.jsp?customHeader=mymeetings&Conference_ID=2416788&passcode=8217181. Upon registering, you will receive a confirmation email with instructions on how to login and join the webinar via internet and telephone.

If you have any questions about the webinar or the Confidentiality and Privacy Issues Related to Psychological Testing Data project, please contact David Bercham at 301-251-0300, x215, or through email at David.Bercham@AMSAQ.com.

US Income, Poverty and Health: FindThe Facts Yourself

2011-01-09T10:47:00.000-08:00

If you prefer facts to rhetoric:

The world's industrial development, wealth and health: where do we stand? A brief informative video illustrates changes over the last 200 years.
http://www.youtube.com/watch?v=jbkSRLYSojo

http://www.cdc.gov/nchs/

http://www.nih.gov/

http://www.macfound.org/atf/cf/{B0386CE3-8B29-4162-8098-E466FB856794}/HCD_NET_Status_Health.pdf

http://www.census.gov/prod/2006pubs/p60-231.pdf

For more, Google "US income poverty and health". Read, think and then communicate with your Congressperson who needs input from constituents rather than more campaign support from lobbyists.

What Do Hearing Aids, Diaphragms, Condoms & Diabetes Glucose Meters Have in Common?

2010-12-21T10:53:00.000-08:00

Quick answer: none of them work when left, unused, in a bedroom drawer.

My focus today is on diabetes and my point is: get a reliable meter (your insurer may have specific models available for you) and test frequently enough (3-4 times a day every day) so that you become the super expert on your diabetes. How does your body react to your medicine? When does your medicine "kick-in"? What are your high and low periods for glucose? When your glucose is high - how do you feel? When your glucose is low, how do you feel? What foods raise your glucose level and how soon after eating them does your glucose rise? When does it drop again? Modern meters give reads which can be recorded in a logbook, or, using computer software for a suitable meter, downloaded, printed and in deliverable form so that your doctor can review your daily records each month and you and your doctor can discuss the findings while your doctor also checks your retina for diabetic changes, your feet for diabetic problems, the parts of your body between your head and your feet, and some appropriate laboratory testing, and then gives you advice on management.

With this information you have a much better understanding of your diabetes, its treatment, and how you can control your sugars!

TV commercials, ads in newspapers and magazines and brochures tout the benefits of new free give-away glucose meters for diabetics from companies which didn't exist a year ago. I chose my meter with my physician and confirmed the wisdom of my purchase by looking - not at my TV set or throwaway ad - but in Consumers' Union (Consumer Reports) which rated a variety of meters in terms of cost and accuracy a year or two ago. The initial cost of a meter is only a small part of its actual cost: glucose test strips, lancets and other simple materials used in testing all are expensive which makes insurance coverage highly beneficial. Some meters are more accurate and reliable than others. The best lancets (which are not significantly more expensive) have very fine needles which are essentially painless. Some meters use strips which require a large blood drop which can be difficult when your fingers are cold, or your hands are stiff, arthritic and have impaired feeling sensation.

A practical example: if at 11:30 AM your glucose is high, is it because your medicine hasn't acted yet, because you ate late, because you ate too much for breakfast, or because you skipped your morning walk? If you've been testing regularly you might know that instead of taking more medicine, you should take a 30 minute walk and then retest to probably find that your glucose came down because the medicine had more time to work and you burned off glucose with your moderate exercise. Wow - doesn't it feel good to be in control?

How Much Is Your Relationship With Your Doctor Worth?

2010-12-12T20:14:00.000-08:00

An over-65 year old friend and I had an interesting conversation. He was being asked to pay almost $2000 a year for himself and the same amount for his wife to remain patients of a physician who was reducing his practice to 600 patients. The only patients who would remain in the practice were to be those paying the access ("access" is my term, not the physician's) fee.

I wondered about this arrangement, which has the name of a major American household product company associated with it. But the first issue, was the most difficult. In economic terms, how does a patient (who is not an expert on the competence, quantity or quality of care a particular physician generally provides, but may have strong emotional ties to the physician) calculate the value of his or her relationship with a particular physician?

I had lots of questions. How does the physician's proposal match up with licensing obligations and his role as a Medicare provider or a provider under the Affordable Care Act ("Health Reform")? How does the proposed relationship coordinate with the various HMOs, PPOs and other insurance arrangements of my friend, which describe themselves as paying for a limited group and range of services and have their own set of "access" requirements? How do the arrangements mesh with the physician's need to take time off from call, sleep, go on vacations, and attend medical education meetings? Assuming that the physician has "on-call" coverage arrangements with other physicians, will those physicians honor the "special relationship" that the up-front cash access payment to the doctor is said to provide? Will consultants to whom the patient may be referred be limited to physicians who engage in similar financial arrangements? Will the patient receive money back if he or she develops a condition requiring intensive care from a different physician, such as an oncologist (cancer), hematologist (benign and malignant blood disorders), nephrologist (kidney disease) or other specialist? What will happen if the physician decides to reduce practice size even further? What will happen if the physician decides to retire? Is the physician moving into "borderline" issues in which the physician is at an unfair advantage, and the patient at a serious disadvantage, in the economic arrangement? Does the "access" fee create a conflict of interest?

In these days of "full disclosure," does the arrangement require special disclosure of information to the patient which might affect the patient's decision: information relating to the quality and quantity of continuing medical education, physician health (including medications taken and substance abuse) or social problems, deficiency notices from medical organizations, hospital medical staffs, governmental bodies, or personal debt which might impact on his practice? After all, the patient is being asked to pay for access not for actual health care, and perhaps "truth in advertising" concepts should apply.

Is the proposed arrangement beneficial to my friend? I don't know. But he has a lot to discuss with his wife and their doctor. After all, we're not just talking about which dishwashing detergent to buy here.

Our Nation's Employment Hot Spot

2010-12-07T16:27:00.000-08:00

Before anyone becomes wildly enthusiastic about changing the projected path of America's Health Care in the next session of Congress check the Bureau of Labor Statistics databases which clearly demonstrate that health care is the employment bright spot in our economy. Make health care unaffordable or unachievable, put healthcare workers out of jobs, and we will worsen our depression and economic outlook.

To pique your interest, here is the health care employment summary chart comparing health care employment in 2010 with 2000. If you want to see more (suggested - follow straightforward instructions at the BLS site), click here.

Employment, Hours, and Earnings from the Current Employment Statistics survey (National)

Series Id:     CEU6562000101
Not Seasonally Adjusted
Super Sector: Education and health services
Industry:      Health care
NAICS Code:    621,2,3
Data Type:     ALL EMPLOYEES, THOUSANDS

Download: Year    Jan    Feb    Mar    Apr    May    Jun    Jul    Aug    Sep    Oct    Nov    Dec    Annual
2000    10739.7    10751.2    10776.4    10782.0    10804.3    10868.7    10892.0    10902.9    10894.7    10925.9    10962.2    10993.7    10857.8
2010    13618.5    13622.4    13671.5    13694.2    13715.1    13768.7    13809.9    13826.9    13804.2    13859.5(P)    13900.5(P)

P : preliminary

Bottom Line: Further tampering with health care may be damaging to America's healthy economy.

Dear Doctor

2010-11-30T11:10:00.000-08:00

Dear Doctor
Am I correct?
That you are less interested in my health problem
Than before?
Is it me or is it you?
Your 10:05 AM Patient.

Dear 10:05 AM Patient
My 9:55 AM patient was much
more medically engaging than you.
My scheduler controls my day
Not me, not you.

Chocolates, Brownies, Fudge and Emotional Depression

2010-11-19T22:16:00.000-08:00

The Christmas season is a time when doctors' offices are deluged with chocolates, brownies, fudge and lots of other goodies which staff and professionals enjoy, though with some guilt.

But there is another side to the holiday season which is more troubling then extra calories and saturated fat. It is the distress of many women we would see with serious holiday depressions because they were exhausting themselves physically, spiritually and financially, trying to make the holidays "perfect" for their families and other loved ones. To the women who read this blog - I wish you well and hope that you will do what you can reasonably do and recognize that perfection is not a human characteristic. To the men who read this blog and pay attention to what their spouses are going through, I suggest you make it a point to notice what is going on around you, support your loved ones and help set family holidays goals which will leave everyone refreshed, rather than exhausted physically, spiritually and financially.

Truly happy holidays depend on the strength and joy of family relationships. What ever holiday is yours, I wish you and yours holiday happiness.

Texas Health Insurance Maternity Benefit Unavailability - Response to Comment

2010-11-15T21:20:00.000-08:00

I don't know whether the commenter is correct that passage of the Affordable Care Act was responsible for strategic actions taken by Texas health insurers to raise rates or make unavailable maternity benefits (2 sides of the same coin). Was the decision by insurers to raise their rates for individuals seeking maternity benefits as part of their insurance package solely due to health care reform or was it a response to actuarial experience (increases in the range of 10-15% have not been unusual in the health insurance business in many states, even before health reform), to the extraordinarily high costs of Texas health care (as documented in 2010 journal articles and federal government discussions), was it a business strategy to mobilize public opinion against health reform, or was it a non-publicized highly selective business or political strategy?

I don't know. Do any of my readers have other insights?

Silence - Not A Winning Strategy

2010-11-05T14:06:00.000-07:00

Last week I spoke to lawyers, retired judges and others at a local bar association meeting about the "Patient Protection and Affordable Care Act" (the "ACA"). As I spoke about the availability of high risk insurance coverage, the Elder Justice Act, parents' health insurance for children up to age 26, Long-Term Care insurance, the support for young families (including college students), and the ultimate effect that supporting and encouraging young families to have children by removing financial and health insurance barriers through providing health insurance and other benefits, it was clear that my audience was hearing this material for the first time. WHY?

It wasn't their fault. Congress passed and President Obama signed a comprehensive health care reform act and the only thing the public heard were a few words from the administration about its benefits and a lot of words from the right about its high costs. The administration spent a lot of time demonizing insurers, provider groups and our existing system but failed to support champions out in the field explaining to groups of citizens why the ACA was specifically in their interests.

In visiting with my Texas family this past week, I heard that a member who has a vital interest in maternity coverage, could not find an insurer who would provide it at a reasonable affordable cost. Thus, her entire concept of health reform is that it has resulted in escalating costs and insurance unavailability. She was right in her observation that her interest in health insurance with maternity benefits is important for her and her family and for our country. So it's time for the Administration to address her issue and at the same time champion provisions of the ACA which are good for American businesses and individuals.

Health care is not a game of golf- 18 holes and a visit to the clubhouse for lunch and drinks. American lives and security are at stake. Mr. Obama, treat health care as a continuing important subject. Commit the resources to champion the benefits that each American will - at some point in his or her life - experience in the ACA.

Otherwise, Americans will face the bleak prospect of unaffordable health care while the lobbyists celebrate victory at their clubhouses.

Kids, You Won't Have to Worry About Mom and Me ...unless

2010-10-24T17:16:00.000-07:00

. . . . "They" (insert suitable descriptive political party, faction or candidate name) repeal The Affordable Care Act and -

*We are old, sick and unable to take care of ourselves (eating, toileting, grooming, dressing, bathing and transferring) and the State decides to send us (or one of us) to a miserable nursing home bed in another county instead of providing us (or one of us) with inexpensive home and community based attendant services and support to rehabilitate us and get us (or one of us) going again.

* The State says that I have no right to be independent.

* One of us gets very sick and "They" have done away with our protection, as recipients of home and community services, of protection against spousal impoverishment.

*"They decide that, in spite of the Olmstead Supreme Court Caser ruling, neither Mom nor I have a right to choose long term services in the community, rather than in an institutional setting.

*"They" wipe out the "Elder Justice Act" which protects Mom and me against physical or psychological harm,elder abuse, neglect and exploitation, improves Long Term Care facilities and gives you the information to know - as our kids - whether those taking care of us are trained, doing their jobs competently and honestly, or are crooks stealing our property and your meager inheritances.

So don't worry - unless . . . .

You, Your Family, the US Preventive Task Force Recommendations and Health Reform (ACA)

2010-10-22T18:36:00.000-07:00

If you have time on your hands and have chosen to study the Patient Protection and Affordable Care Act, you have seen many references to the US Preventive Task Force Recommendations. The ACA references Grade A and B recommendations and tells you that you will qualify, often without charge at all, to receive care specified in those A and B recommendations and implies that that your physicians and insurers had better be familiar with those recommendations because they are binding on them.

I have been around long enough to know that some patients are more knowledgeable about health issues on the internet than their physicians and other providers, so here is the link to the task force preventive services recommendations with my personal recommendation (I am your blogger, not your doctor) that you read through them and - when you have questions about how the recommendations apply to you, your spouse or partner, your kids or parents or grandchildren, you ask your doc (or other provider or even insurer) those questions. You may get some blank stares. You may even face some obvious discomfort or annoyance. But do it anyway, if for no other reason, than your doctor (or other provider) needs to know about them and needs to know that you and other patients and their families know about them. That's how we change behavior and impose new and BETTER societal standards of medical care. So let's do it.

Response To Comments About Health Care Costs

2010-10-19T13:05:00.000-07:00

The Congressional Budget Office projected a $196 billion dollar savings over 10 years. Almost $13 billion from hospitals, about $14 billion from SNFs, about $22 billion from Medicare Part B cuts (durable medical equipment, labs, ASC, Dialysis and other services), and almost $40 billion from home health. Medicare Part D premiums will rise as much as 9% over 10 years, primarily as a result of donut hole closure steps.

Here are some links to interesting reading about the economics of US health care costs. I don't pretend that I have personally read every one:
http://www.gao.gov/htext/d04793sp.htmlhttp://www.gao.gov/docsearch/featured/healthcare_spending.html
http://www.gao.gov/docsearch/app_processform.php

If the Republicans Repeal Health Reform -- Then What?

2010-10-17T14:22:00.000-07:00

As I have reported, and one of my sons mentioned to me in this morning's phone call, I have plowed my way through 906 single-spaced pages of the Patient Protection and Affordable Care Act ("ACA") which President Obama signed last March. I have read numerous blogs (including those of the Director of the Congressional Budget Office which, being written for Congress people and their staffs, are written clearly) some of which demonstrate complete unfamiliarity with the actual text and meaning of the ACA. I am convinced that many public statements about the ACA reflect uninformed for personal-profit political positions more than hard time-consuming actual work to understand and think about the act.

A disclaimer - I have my biases. As a physician specialist, I took care of very sick people, never turned anyone away because of insurance status or lack of it, and have no respect for those that do. I have a large family which has seen more than "its share" of sickness and disease and death and my family has been significantly impacted by our severe recession. I have been the Chief of Staff of a large mid-city hospital, now closed and abandoned, and have seen what economists call "dislocation" and the rest of us call bankruptcy in health care. I have seen excellence and incompetency in health care and the systems which deliver it. I was a member of Stanford University's clinical faculty, providing one morning a week of unpaid time for thirteen years, taking care of veterans with blood diseases at the Palo Alto VA hospital and teaching medical students, residents and hematology fellows. As a member of a powerful well-financed state hospital industry board, I have seen political and economic jousting within and outside the hospital industry. When I practiced health law, among others, I represented a large medical group and was heavily involved in the analysis and negotiating of managed care contracts as well as contracts among physicians and their practice entities.

Bottom line - if health reform is repealed we will be worse off. The good outweighs the rest.

The ACA will provide access to insurance for Americans who have lost employment and their families' health insurance and don't have enough money to buy Cobra extended coverage. The ACA outlaws insurance company abuses and will provide health insurance and care to our kids and grandchildren. The ACA will provide incentives to employers to sign their workers up for insurance, insurance which cannot be rescinded or be subjected to unreasonable annual coverage limits or lifetime limits. The ACA will expand Medicare coverage for Part D beneficiaries although there will be a modest increase in premiums over the next ten years and it will even help seniors to stay out of nursing homes, or if in nursing homes, have better quality of care (Also see the Elder Justice Act within the ACA at pages 664 and following) The ACA will improve access to care in rural and underserved areas and the care of the poor. It will train doctors, nurses and others in the health professions without burying them and their families in debt. It incorporates an "Elder Justice Act" which may safeguard seniors against some of the terrible things that I saw happen to my older patients. It has strengthened protections against fraud and abuse. And, it encourages advances in medical inventions, products and care which moves us into a new generation of health services.

The projections are that it will save about $14 billion dollars each year for the next 10 years and thus control the rise of premiums and out-of-pocket expenses that each of us experiences each year. And interestingly, it will make it possible - through support of America's families and children - to grow our workforce so that in coming there will be young working people able to fill the jobs that America offers and help America's businesses.

My study indicates that health reform is good for families, good for working-people and those who would work if they could find work, good for America's supply of doctors, nurses and health care workers, good long term for large and small business and less costly than the alternative - no health care reform.

Doctors Groups Fail Because They Don't Understand Risk

2010-10-14T23:34:00.000-07:00

The October 7, 2010 New England Journal of Medicine has two interesting articles, one by Harold S. Luft, Ph.D. titled "Becoming Accountable - Opportunities and Obstacles for ACOs" and the other "The Effects of the Affordable Care Act on Workers' Heath Insurance Coverage" by Christine Eibner, Ph.D. and others. Like the Affordable Care Act, neither of the articles discusses an issue which my experience tells me has played a major role in the failure of a number of physicians' practices to survive managed care and other forms of contracted health care relationships.

Insurance companies understand risk: they hire skilled actuaries to analyze underwriting risk and to tell them about it and how to shuffle it off to others. The Federal Government understands risk, and as one plows through the 900+ pages of the Affordable Care Act, there are many references to the requirement that highly sophisticated actuarial studies be done to guide future policies and actions But individual doctors don't have the financial means to hire actuaries (or attorneys) to tell them about the risks that they blithely assume, and even if they did, their fracturing into relatively small business entities makes the per-doctor cost of securing actuarial advice prohibitive. And then there are antitrust issues when groups of physicians combine resources to strengthen their ability to negotiate with employers, government and insurers. So insurers, government and business shift risk to physicians who bite off more than they can chew - and choke.

The current proposals for health reform is not going to solve that problem. As physicians learn that the emphasis on "efficiency" and driving down the cost of services leaves their bank accounts empty, I expect them to resort to their experience-tested means of generating income: see more patients, do more procedures, order more tests and ramp up the billing. In this era of "evidence-based care," ironically it is the physicians who lack evidence about the business risks they are asked to undertake by insurers, government and businesses.

Acountable care organizations will not survive in that environment.

The Prism of Ethics: Quiet Plans to Change MEDIGAP Insurance

2010-10-11T21:11:00.000-07:00

I remember Dan Rostenkowski's expressions of disbelief, when he joined our meeting of the executive committee of the National Health Lawyers Association in Chicago about 20 years ago. A couple of days earlier, he had been physically attacked with canes and umbrellas by little old men and women whom had represented in Congress for years. Their concern that legislation he supported would raise their costs of prescription drugs made them furious. Twenty+ years later, other Chicago based political figures have chosen not to learn from Rostenkowski's experiences

The following vaguely-written section of the Affordable Care Act buried at page 342, seems to predict significant MediGap change (you will have to refer to your own MediGap insurance brochures to determine how it might affect you). I have underlined the words which I consider most problematic.The approach appears to be double-barreled: (1) reduce Medicare beneficiaries access by raising the cost of plans which might give their purchasers more extensive (or appropriate for their needs?) physician Part B services and (2) directly or indirectly create barriers to physicians' services to reduce high users (i.e., the sick elderly) access. Since my experience is that older Americans choose their MediGap insurance very carefully and pay the increasing premiums out of hard-earned dwindling financial reserves, I am concerned about the implications of this section for seniors.

SEC. 3210. DEVELOPMENT OF NEW STANDARDS FOR CERTAIN MEDIGAP PLANS.
(a) IN GENERAL.—Section 1882 of the Social Security Act (42 U.S.C. 1395ss) is amended by adding at the end the following new subsection:
‘‘(y) DEVELOPMENT OF NEW STANDARDS FOR CERTAIN MEDICARE SUPPLEMENTAL POLICIES.—
‘‘(1) IN GENERAL.—The Secretary shall request the National Association of Insurance Commissioners to review and revise the standards for benefit packages described in paragraph (2) under subsection (p)(1), to otherwise update standards to include requirements for nominal cost sharing to encourage the use of appropriate physicians’ services under part B. Such revisions shall be based on evidence published in peer-reviewed journals or current examples used by integrated delivery systems and made consistent with the rules applicable under subsection (p)(1)(E) with the reference to the ‘1991 NAIC Model Regulation’ deemed a reference to the NAIC Model Regulation as published in the Federal Register on December 4, 1998,
and as subsequently updated by the National Association of Insurance Commissioners to reflect previous changes in law and the reference to ‘date of enactment of this subsection’ deemed a reference to the date of enactment of the Patient Protection and Affordable Care Act. To the extent practicable, such revision shall provide for the implementation of revised standards for benefit packages as of January 1, 2015.
‘‘(2) BENEFIT PACKAGES DESCRIBED.—The benefit packages described in this paragraph are benefit packages classified as ‘C’ and ‘F’.’’.
(b) CONFORMING AMENDMENT.—Section 1882(o)(1) of the Social Security Act (42 U.S.C. 1395ss(o)(1)) is amended by striking ‘‘, and (w)’’ and inserting ‘‘(w), and (y)’’.

The Prism of Ethics: Was This Change to Medicare Part of the Plan?

2010-10-08T14:20:00.000-07:00

In preparation for a talk about Health Care Reform that I am scheduled to give to the West Valley Bar
Association, later this month, I have been going through the Patient Protection and Affordable CareAct [the "ACA"] page by page, line by line and word by word.

At page 271 of the AFA, PART III is entitled "Encouraging Development of New Patient Care Models" which seems benign enough. But as I moved along to page 277, I came upon Section 3022 "MEDICARE SHARED SAVINGS PROGRAM" which describes "Accountable Care Organizations" (ACOs), groups of providersd who may "work together to manage and coordinate care for Medicare fee-for-service beneficiaries through an accountable care organization." Sounds benign enough. But then I read on.

At page 279 there was this language: "(c) ASSIGNMENT OF MEDICARE FEE-FOR-SERVICE BENEFICIARIES TO ACOs.-The Secretary shall determine an appropriate method to assign Medicare fee-for-service beneficiaries to an ACO based on their utilization of primary care services provided under this title by an ACO professional described in subsection (h)(1)(A). (Underlining supplied) Just a moment - I thought that under fee-for-service Medicare, patients chose their own doctors, but this section appears to take away that choice in the interest of a Medicare Savings Program study. And then, I found this section at page 280:

"(g") LIMITATIONS ON REVIEW.-There shall be no administrative or judicial review under section 1869, section 1878 or otherwise of -
"(1) the specification of criteria under subsection (a)(1)(B);
"(2) the assessment of the quality of care furnished by an ACO and the establishment of performance standards under subsection (b)(3);
"(3) the assignment of Medicare fee-for-service beneficiaries to an ACO under subsection (c) (underlined supplied) . . . . .

So, some Medicare fee-for-service beneficiaries may be plucked out of their chosen physicians' offices and reassigned to an "ACO" with no right of appeal? Is my reading correct?

Gee, did President Obama, or the people pushing this "reform" bill through Congress mention that to the people potentially affected?

Interesting New HIV/AIDS Potential Treatment Report

2010-09-29T11:32:00.000-07:00

In the early 1980s, as a physician and volunteer professional chair of a local Red Cross Blood Services advisory committee, and later as the Chair of Northern California Red Cross Blood Service's Board (and subsequently, for the Western United States), I had the chance to experience the impact of HIV on patients, my community and on national blood transfusion programs. As a practicing clinical hematologist, I sat through many meetings about HIV and AIDS, most of which highlighted highly pessimistic views about preventive measures such as education, pharmacologic measures and vaccines. As a healthcare attorney, and author of a chapter concerning HIV-infected health care workers in the Health Law Guide, I was able to sound a more optomistic note as effective treatments evolved, allowing HIV infected people to experience dramatically improved qualities of life and survivals. But no approach suggested cure.

In an AIDS RESEARCH AND THERAPY abstract from a recently published report from Israel, Aviad Levin and others, at The Hebrew University of Jerusalem, state:

"A correlation between increase in the integration of Human Immunodeficiency virus-1 (HIV-1) cDNA and cell death was previously established. Here we show that combination of peptides that stimulate integration together with the protease inhibitor Ro 31-8959 caused apoptotic cell death of HIV infected cells with total extermination of the virus. This combination did not have any effect on non-infected cells. Thus it appears that cell death is promoted only in the infected cells. It is our view that the results described in this work suggest a novel approach to specifically promote death of HIV-1 infected cells and thus may eventually be developed into a new and general anti-viral therapy."

The report does not promise cure, but does describe a serious advance in the potential for treatment of HIV infection. It is worth reading.

"Shifting the Health Cost Burden"

2010-09-28T15:59:00.000-07:00

On 9/3/2010 The New York Times editorial page discussed shifting the health cost burden. The editorial noted that 2010 health care premiums went up a "modest" 3% for family plans but that workers' shares soared by 14% and expressed what I interpret as "unhappiness"about the cost shift from employers to workers in the form of increased workers' contributions, reduced benefits, increasing deductibles and increasing copayments.

Employers don't take these actions in a vacuum. Insurers structure their plans and premiums to encourage employers to remain with them by manipulating benefits, deductibles and copayments to remain competitive. Struggling employers, including those who "shop," have few real choices, as health insurance underwriting restricts insurance company willingness to accept high risk business, particularly business which involves demonstrably sick or older employees. Paradoxically, the longer an employer stays with an insurer, the greater the risk that long-term employees and employees loyal to the employer because of personal or family illness insurability issues, drive up health insurance risk and the premiums. Perhaps health reform will change this picture, but perhaps not.

The Times said nothing about reducible costs of health care, such as (1) eliminating large duplicative professional, business and government bureaucracies which officiously pass paper (and digital data) back and forth and spend endless hours in defining policies and procedures intended to trace, identify, categorize and restrict reduce health services utilization while increasing administrative overhead (2) reducing technology barriers, such as requiring physicians to be data entry clerks for office visits rather than use their time and skills evaluating, diagnosing and treating their patients, (3) finding ways to increase and maintain the skills and efficiency of all categories of health care professionals free of contributions from pharmaceutical companies and other vendors, (4) providing appropriate subsidies, expertise and legal authority to government and professional entities (including the FDA, Department of Agriculture among others) active in the public health arena, (4) eliminating subsidies which make our citizens fat, physically inactive and ignorant of how to recognize and deal with their own health needs, and (5) admitting that health care reform focuses on access to and financing of health care and not the extent and quality of appropriate and necessary health services.

It's easy to complain about the cost shift burden. But focusing on the reasons for excessive health care costs will step on many vested interest toes. Will true reform even drive down some of the high-flying health invested mutual funds?

What About My Child Who Was Cured of Cancer?

2010-09-23T21:17:00.000-07:00

For several days, radio and televisions broadcasts have said it: beginning September 23, 2010, under the Affordable Care Act applying to grandfathered group health plans, health insurance enrollees who are younger than 19 years of age cannot be excluded from benefits or denied coverage because a condition was present before the date coverage became effective (or denied).

The hype sounds good, but what if your 19-26 year old child was treated for heart disease, lung disease, cancer, leukemia, Hodgkin Disease, Wilson's Disease or any other serious condition and the insurance company says "no" to someone age 19-26 with a pre-existing condition under the grandfathered plan? (A grandfathered plan was one existing on March 23, 2010 and a new plan is one established after that date.) While minors must be covered, not until 2014 will the pre-existing prohibition for adult children be eliminated.

Sophisticated advisers stress the importance of keeping a close eye on employers' grandfathered plans. When new insurance is written or major revisions to existing plans take place, "grandfathered" plans may become new plans and work under a whole new set of more consumer- protective rules. Pay attention.

Health Reform: Upset WIth Democrats, Afraid of Republicans

2010-09-16T22:29:00.000-07:00

My take, based on conversations with professionals and just plain people, is public apprehension about the impact of the 2010 health reform package. On the one hand, people complain about the threat of federalization of health care and on the other, they demand that their Medicare program not be affected by health reform. While there is recognition of the need to clean up the the old inefficient expensive system which provided economic rationing of care, there is a sense that the political parties are at odds, and that any gains made since passage of health reform in March, 2010 will be undone by Republicans should they gain control of Congress. The uncertainty created by Democratic passage of reform is threatened by the fear that - if the Republicans can control health care - it will be the bad old days again and people will sit in movie theaters (or in front of their big home TVscreens) booing insurance companies, HMOs and any theatrical reference to institutions that control of health care.

The Democrats haven't exactly made it easy for the public to understand what is happening and what will happen under health reform. A recent posting of a letter from Kathleen Sebelius calling on Health Insurers to Stop Misinformation and Unjustified Rate Increases, said

"Any premium increases will be moderated by out-of-pocket savings resulting from the law. These savings include a reduction in the "hidden tax" on insured Americans that subsidizes care for the uninsured. By making sure insurance covers people who are most at risk, there will be less uncompensated care, and, as a result, the amount of cost shifting to those who have coverage today will be reduced by up to $1 billion in 2013. By making sure that high-risk individuals have insurance and emphasizing health care that prevents illnesses from becoming serious, long-term health problems, the law will also reduce the cost of avoidable hospitalizations. Prioritizing prevention without cost sharing could also result in significant savings: from lowering people's out-of-pocket spending to lowering costs due to conditions like obesity, and to increasing worker productivity - today, increased sickness and lack of coverage security reduce economic output by $260 billion per year."

Walk into any hospital Emergency Department and you may observe terribly sick and injured people who, because they are not insured American citizens, may still run up substantial costs which will be shifted to the insured population making the Secretary's claim of dubious validity. We need the facts to substantiate claims of savings as an offset to the doubts proclaimed by the political and corporate opponents of health reform.

Otherwise we will have more upset which will outweigh fear.

Who Will Judge Your Health Care Coverage?

2010-09-09T23:45:00.000-07:00

Two articles in today'[s New York Times referenced health care costs on the reform bill. Stating that the reform bill focused on health care access, rather than cost-control. Jonathan Bush opined that health reform will be cost-expansionary. But Andrea Sisko, the main author of a government report predicted modest effects on the growth of health care cost to accompany a marked increase in access as more than 30 million people gain insurance coverage, although the article citing her report notes that growth in health care spending will increase from its 17.3 percent of the gross domestic product to 19.6 percent in 9 years.

Will our government be forced - by economic realities - to make new changes to health care coverage, limiting benefits for conditions now covered, imposing age barriers to obtaining palliative or even curative therapies, or barring individuals from health care coverage for conditions which they developed as a result of damage which they self-imposed, such as the use of drugs, high risk sexual behavior, abuse of alcohol, and perhaps even consuming types and quantities of foods known to increase the risk of diabetes, heart disease, hypertension, obesity related joint disease and other conditions? Will government move towards pragmatic limits which will reduce scientific research, impose restrictions which favor the young and healthy, and make individuals primarily responsible for the consequences of lifestyle decisions which end-up costing society money?

Who will judge and who will be judged? Who will live and who will die?

Who by Fire?

Highly Sensitive Information

2010-09-07T20:02:00.000-07:00

When I practiced internal medicine, asking a patient to go through psychological testing usually meant that the patient would never return to my office. The issue was too sensitive for many reasons, including the possibility that someone related to the patient socially or through a business connection (i.e., a spouse, employer or insurance company) would gain access to that information with serious consequences for the patient.

The sensitivity of psychological records remains an issue under federal privacy laws. Following, is a notice I received today (9/7/2010) which may be of interest to my readers:

Before You Drink That 6-Pack . . . .

2010-09-04T20:53:00.000-07:00

As I walked into my local supermarket to buy some flowers for the weekend, I saw the 6-packs of beer leaving the store, tightly clutched in customers' hands. It made me wonder:
1. Do you believe that drinking the Labor Day weekend 6-pack will make your "crowd" like you?
2. Do you believe that drinking the Labor Day weekend 6-pack will make you more sexually attractive?
3. Do you believe that drinking the Labor Day weekend 6-pack and driving does not increase your risk of an auto accident, a DUI citation, large hospital bills resulting from that auto accident, loss of auto insurance, lawyers' bills, and grief?
4. Do you believe that drinking the Labor Day weekend 6-pack will bring you joy?
5. Do you believe that drinking the Labor Day weekend 6-pack will absolve you of responsibility for an unwanted pregnancy?
6. Do you think that drinking the Labor Day weekend 6-pack and others, doesn't increase your risk of alcoholic liver disease, esophageal cancer, mouth and throat cancer (especially if you smoke) and gastrointestinal bleeding?
7. Do you think that the only friends worth having are the ones that will consume their own Labor Day weekend 6-packs followed by lots more?
8. Do you think that drinking 6-packs has an effect on your weight?
9. Do you think that drinking 6-packs has an effect on your school or job performance?
10. Do you really believe what the brewery ads imply, that the only way to have fame, fortune, friends, sex and happiness is to find it in the bottles they sell?

Ask any doctor or nurse who works in an emergency room what he or she thinks based on real life experience.

Don't Rush To The Newest Drug

2010-09-02T22:35:00.000-07:00

In its September/October 2010 edition of the American Society of Hematology's The Hematologist, Pete Lollar, M.D. reviews a report by Dutton, Wayman and Wei describing previously unknown actions by the anticoagulant warfarin (proprietary name - Coumadin) used to combat abnormal venous and in-heart clotting which can produce strokes and pulmonary emboli with catastrophic results. Warfarin is also used as rat poison.

The report notably reports that vitamin K-dependent proteins involved in clotting involve vitamin K epoxide reductase ("VKOR") which is inhibited by warfarin. Humans are not the only life form which uses takes advantage of VKOR, since some bacteria including the one causing tuberculosis partially share VKOR activity.

There is a great deal of interest in new drugs which are being proposed to replace warfarin, a product which has been available since 1948 and, in addition to preventing strokes and pulmonary emboli, may be responsible for serious bleeding, particularly in women above age 80. We are only beginning to understand the subtleties of the biologic action of warfarin. When presented with the newcomer anticoagulants, how long will it take for us to understand how they work, and how many patients will experience serious unanticipated consequences of their adoption which we do not fully understand? Serious unanticipated consequences which rival the monitoring, cost savings and bleeding episodes now experienced with warfarin.

REPUBLICATION

2010-08-21T14:28:00.000-07:00

We have a serious epidemic of a very serious disease, pertussis (whooping cough) and a substantial number of parents who have chosen not to provide their children with pertussis vaccination, I am republishing this post first written in January 2010.

If your child has friends who have not been vaccinated, consider finding other friends for your kid. If your child has not been vaccinated, be prepared to lose friends.

REPUBLICATION

In a recent study reported to physicians by Medscape (the original article appeared in the January issue of the Archives of Pediatrics & Adolescent Medicine), approximately 5% of the children who were studied did not have varicella vaccination because of parental refusal. The study found that the children whose parents refused to have their children immunized were at "high risk" of varicella infection compared to children who were vaccinated.

Today, a parent's refusal to vaccinate with a medically proved effective and safe vaccine has no societal consequences for the parent other than the guilt which he or she may shoulder from severe complications of varicella infection in his or her child. Other parents, and their children who become infected as a consequence of each refuser's decision (such as children with immune disorders or leukemia who cannot be vaccinated) unfairly bear all of the financial and personal liability flowing from the original refuser's decision, a decision in which they did not participate.

A straightforward marketplace approach to the parents' vaccination decision making could be relatively simple. After being provided with relevant information, a parent who denies his or her child the protection of vaccination (or does not present the child for vaccination) becomes liable for all economic and "pain and suffering" consequences of all downstream infections which can be traced back to that child by public health authorities. Guaranteed freedom of choice, the refuser could insure against such liability, or could post a bond which he or she purchases.

Adoption of this approach would reduce the cost of health care because it would prevent the refusing parent from shifting the cost of the decision to payers and other parents. The refusing parent could reduce his or her exposure to liability through insurance, bringing the opportunity for new business to insurers. Attorneys actuaries, public health officials could be engaged in the "fight against preventable disease". It's a "win-win".

Who Speaks For The Others?

2010-08-19T18:04:00.000-07:00

Large and small hospitals may not advertise the fact that they have biomedical ethics committees, but they do. If a patient's family asks "can Dad's case be reviewed by a biomedical ethics committee?" the answer may be "yes, but, we don't think that's necessary" or it may affirm the availability, willingness to meet and consider Dad's case, and the experience and expertise of the committee in formulating recommendations. Or sometimes, review of Dad's case is suggested by a hospital staff person or physician, familiar with Dad's case who also understands the issues Dad's medical and social condition present and seeks help.

This blog isn't about Dad, the subject of biomedical ethics committee attention. This blog is about the focus of the committee on Dad which excludes consideration of the impact of its decision and recommendations on other individuals and communities which the institution serves.(biomedical ethics committee opinions are commonly in the form of recommendations to the doctors, staff and family, and those recommendations reflect consideration of Dad's medical and social issues, discussion with the family, review of hospital and medical staff policies and procedures, consideration of standards of care and sometimes consideration of applicable law). The review is targeted on Dad and his immediate survivors.

A simple example: the committee recommends that Dad, who is terminal, receive full resuscitation efforts because that is what Dad's family says they want and their customs demand. Dad dies. One minute after the team begins Dad's resuscitation, a young patient suddenly and unexpectedly experiences cardiac arrest which would respond to competent resuscitation if the resuscitation team weren't occupied with Dad's fruitless resuscitation. Dad is declared dead, the young patient receives less than optimal resuscitation and survives in a vegetative state. The decision about Dad directly impaired the care another patient received, but the biomedical ethics committee focused only on Dad. No one represented the interests of the potential "others" at the biomedical ethics conference table. When a family aggressively demands services which cannot alter the outcome of care, they may not appreciate or care about the effect of the satisfaction of that demand on the hospital's ability to provide appropriate care to other patients. But this sensitive issue is not often raised in committee deliberations and discussions.

When antibiotics are provided with knowledge that they will not affect the patient's outcome, the appearance of antibiotic resistant bacteria become a threat to all of the patients and communities that the hospital serves. The national cumulative effect of antibiotic resistant bacteria means widespread unnecessary suffering from infections which will not respond to "standard" antibiotics, a huge expenditure for tests and treatments, and preventable mortality. When, with biomedical ethics committee recommendation, an intensive care unit breathing tube is inserted with no expectation that the comatose patient will awaken or ever be weaned, that bed, those staff people, that equipment and the opportunity to care for someone who is highly likely to recover, may be irretrievable.

My suggestion is straightforward. In each biomedical ethics committee case review, one person be appointed to speak for the interests of the "others" - the patients whose lives and care may be impacted by the recommendations for a decision to be made about "Dad." Committee recommendations may not change, but the process will be more honest and inclusive..

Health Care Costs Requires A Long View, Not A Two Minute Sunday Morning "Talking Point" Presentation Invoking the National Deficit As An Excuse

2010-08-12T22:45:00.000-07:00

You probably know the answer to the questions which follow, but Representatives and Senators, who claim to operate for the good of the nation and its people go on television on Sunday mornings and ignore the obvious answers because they are not beholden to you, they are beholden to their funding corporate interests.
1. In the long run, does our country save money by providing access to all children for vaccination for serious childhood diseases? If yes, why don't we do it?
2. In the long run, does access to health care, yield healthier adults whose life time health care expenses are lower? If yes, why don't we provide that access now?
3. In the long run, does providing competent, accessible and affordable obstetrical care for all women reduce the likelihood of injury during obstetrical delivery? If yes, why don't we provide that care now?
4. Does pollution-free clean air reduce the frequency of death and expensive emergency hospitalizations for children and adults? If yes, why are we battling about environmental protection and clean air?
5. Does providing supervised physical activity for kids, instead of sitting them on sofas at home watching TV, help children to be more physically fit and to reduce the long-term costs of their care? If so, why are our kids parked in front of television sets?
6. Does enforcing employment safety rules reduce the frequency and cost of injury born ultimately by the public? If yes, why don't we enforce them?
7. Does the provision of appropriate prescribed medications which the elderly can afford make it more likely that they will take the medicines prescribed by their physicians? If yes, why don't we provide them?
8. Does the provision of appropriately inspected and approved food reduce the number of annual deaths from food poisoning? If yes, why are we experiencing food-borne outbreaks of disease and death?
9. If we have a test for Alzheimers disease, does that mean we can cure the disease? If we have no genuinely effective drugs for Alzheimers Disease, why don't the news reports say so?
10. Is it OK to have "a little diabetes"? If it isn't, what is our national policy to prevent diabetes?
11. Is it better to have a patient with cancer seen earlier or later by competent health care providers? Ask any doctor or nurse.
12.Is there any sensible reason why the federal government negotiates pharmaceutical prices for the Veterans' Administration beneficiaries but not for those who pay for Medicare Part D? So why doesn't it?
13. And finally, other than fancy words, what is our Administration, Congress, our Legislatures and Governors doing today to make Americans healthier?

Failure to provide competent accessible ethically appropriate care at all life stages inflates our long-term health care costs, seriously increases our budget deficit and harms our quality of life. Why are our President, Senators, Congresspeople, state Governors and legislators not talking about the real issues now?