FDA Admits Failing To Inspect China Supplier

Today's leap year surprise is the prominent front page article in The New York Times proclaiming "A Blood Thinner Might Be Linked To More Deaths." The article is a surprise because the FDA has been underfunded and undercommitted with respect to inspections of drug manufacturers and suppliers outside the United States for years, and the Times just got around to noticing it.

Several years ago I (and several others) met for breakfast with the then Director of the FDA who told us pointedly that the FDA was incapable of inspecting pharmaceutical manufacturing facilities outside the United States because there was no political will to do so (as demonstrated by failure of several administrations to propose such inspections)and Congress neither demanded nor budgeted the FDA to conduct such inspections. The FDA had difficulty in obtaining funding for its mandates in the United States and was incapable of taking on a sophisticated international role.

Folks, there aren't earmarks for FDA international pharmaceutical quality, safety and effectiveness inspections. Without money, staff, training and commitment, the FDA is incapable of safeguarding our pharmaceutical supply. The next time your Congressperson offers to build a new road for your community, why not ask for a safe traceable medication supply policed by a well-funded and competent FDA instead?

Who Owns Your Health Information?

You may have noticed recent articles concerning Microsoft's and Google's interests in data banking health information. Each of these companies (and many others) must deal with this issue: who will own the health data contained in their data banks? Microsoft, Google, and most of the other commercial interests are not health care providers or partners of health care providers, and will not be subject to existing federal and many state health care privacy restrictions. So whom do you, the reader, believe will own your electronic data? What controls would you expect to be placed on the profits to be obtained from exploiting the ownership of your data (and should you share in those profits)? And what limits should be placed on the use of your data?

More About Your Health Privacy

California has adopted legislation (AB 1298 - signed 10/14/2007) which provides that when a person's name plus medical information or health insurance information in unencrypted computerized form are acquired, or believed to be acquired, by an unauthorized person, individual notification of the breach, regardless of whether the social security numbers are involved, is required.

The "Privacy Legislative Update" (www.dhcs.ca.gov/Pages/LegislativeUpdate.aspx) indicates that the intent is to prevent the growing crime of medical identity theft and to protect confidential medical information by encouraging encryptation. Whenever there is a breach of computerized unencrypted data containing a person's name, California's Department of Health Care Services must determine whether data that has become lost or stolen or transmitted to an unauthorized party would trigger a security breach notification. Such information now includes two new categories: (i) health insurance information - defined as health insurance policy or subscriber numbers, any information in an individual's application and claims history, including any appeals records; and (ii) medical information - including any information regarding an individual's medical history, mental or physical condition, or medical treatment or diagnosis by a health care professional.

If you are not in California or a state which provides similar protection, you might wish to contact your state legislators to learn "why not?"

Your Partners in Health

When you left your doctor's office, after your last visit, you probably believed that the relationship and communication between you and your doctor was personal, private and confidential. Sorry. Although federal (and state) law provides for privacy, those items that the doctor discussed and wrote notes about in the medical chart paper or computer) are not only available to the doctor's staff and office associates involved in your care, but potentially to insurers and their personnel, payers, claims managers, case managers, peer reviewers, agencies such as Medicare and Medicaid, licensing authorities, and by virtue of subpoena, to attorneys, other officers of the court, and perhaps to members of a jury, as well as to certain police and investigative officials. When your doctor or health provider gives you a notice of HIPAA compliance, read it and then, when you get home, go to the government site http://www.hhs.gov/ocr/hipaa/ to have a better understanding of the privacy to which you are entitled.

Does Kansas Lead The Way?

See http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=50534 which discusses: "States Look To Increase Number of Insured Young Adults by Allowing Them To Stay on Their Parents' Health Coverage Longer". A Supreme Court ruling may be needed to settle the issue of whether states can force employers who provide health insurance under ERISA to provide this extended coverage.

Dealing With Medically Underserved Areas

Medical education is already heavily subsidized (tuition does not cover the educational institutions' costs). Some young physicians choose their career paths primarily based on their assessments of how quickly their earnings will pay off their debts. There could be an alternative: provide financial incentives to medical students, interns, residents and fellow to choose the specialties which America needs, where the needs exist, and commit to providing them with free educations if they serve in designated medically underserved areas for a defined period following completion of their training. If the young physician's career objective is to be a Beverly Hills cosmetic plastic surgeon, he or she should receive no subsidy or income guarantee; if he or she will contract to practice plastic surgery in an inner city hospital for seven years, provide a generous subsidy which makes the medical training free and provide a reasonable and adequate income so that the physician can support his or her family. The decisions on need and location cannot be left to the medical profession alone, nor to hospitals, because the medical profession and health institutions will game the system for their advantage.

On January 8, 2008, the New York Times captioned a major article: "Health Spending Exceeded Record $2 Trillion in 2006". It observed that health care spending nearly doubled in the last decade, amounting to an average of $7,000 a person. The Times reported that health spending accounts for 16% of "the total amount of good (sic) and services". Paradoxically, health spending by businesses showed the slowest rate of increase since 1997 - 5.7% in 2006, which could be accounted for by employers shuffling off payments for private health insurance (i.e., prescription benefits) to Medicare which provided a new drug benefit. So where were the significant increases? Predictably retail spending on prescription drugs increased by 8.7% to $216.7 billion (related to the Medicare Part D program). But administrative costs "increased more than twice as fast" while spending on hospitals, doctors and nursing homes deaccelerated.

Health care is very big business (and a major employer) in the United States and before anyone tries to make a dramatic change in the structure or payment system of health care by political fiat, we all have to understand that a hiccup in health care will have a major economic impact on the country. That "hiccup" may cause "dislocations" which is an economist's way of describing bankruptcies, job loss and business disruption.

One consideration is that health care costs can be viewed on a global scale. Another is that those who can't afford to buy insurance and pay health care bills are often not the poorest, who receive help from Medicare and Medicaid, but those in the lower middle class and those who operate marginally profitable businesses. Why don't we tie these concepts together by recognizing that when we purchase goods and services from countries which do not invest in health care for their citizens (or when we allow our businesses to 'offshore' production to those countries), and insist that our citizens and employers provide insurance and pay health care costs for Americans, we are creating two problems. We are importing low cost goods and services and losing American jobs through unfair competition and we are subsiding foreign governments and businesses which refuse to provide a real system of health care for their own people because then they would have to compete on an equal playing field with American business and labor.

Why don't we consider constructing a health care cost index of per capita spending for the countries we trade with. Those countries that are significantly lower in the index than we are, should pay an import "health" premium (a tax on each imported item from that country) to be used to offset the cost of health care for Americans. That levels the playing field and reduces the unfair competitive advantage that some countries now enjoy. And when those countries spend more on their own citizens' health, they can benefit from a higher relative index and a lower health care "tax". We can provide an incentive to improve global health, give American businesses the opportunity to compete fairly, provide health care to the 47 million uninsured in America, and perhaps create some jobs at the same time.

Food or Health Care?

While our health care system could be more efficient, less expensive, and more cost-effective, health care will always be costly. The political proposal which requires everyone to pay for insurance, or work for an employer who will provide insurance, suggests that the proponent is living on a different planet. Not all people and not all businesses can afford to buy insurance.

One of my most significant experiences in medical school was to be sent to a spotlessly clean home in Brooklyn, New York where I spoke with two employed uninsured parents (each worked for small marginal businesses) who lived with their children. Because they were employed and had some earnings, they could not qualify for "welfare" and subsidized health care. As a result, they had to choose whether to eat or pay for medical services and medicine for their epileptic child. The parents were willing to forego food.

A number of years later, I sat in the basement of a restaurant in Chicago with co-members of the board of the National Health Lawyers Association. These were among the most sophisticated attorneys in the United States and individually dealt almost exclusively with health care issues. We talked about their personal fears about health care for their families. Without exception, each was worried about the cost and availability of health care for his or her young adult children. Each was worried that if his or her adult uninsured child became seriously ill, the parent would become the payer and the family savings would be exhausted.

The need for health care and health care security cuts across professional lines, gender, education, ethnicity, religion, economic status and any other category. Our country can implement a high quality health care system for all if the will is there.

Do You Receive Adequate Quality Health Care?

If you are a young man or woman, and see your doctor infrequently because you know you are in good health, the insurers want you. The young healthy nonuser of health care is what keeps insurers and HMOs not just solvent, but profitable. So there you are, making money for your health care insurer or HMO, going to see your doctor every few years - probably for a bad cold. When you see your doctor, what is the quality of the care you get? Do you know how to assess quality, other than by the time you have to wait to see the doctor and the age of the magazines in the waiting room?

Does anyone check your skin for melanoma? Does anyone check your neck for a thyroid nodule? Does the doctor (or other health care professional) check a young man's testicles for a mass? Does the doctor check the woman's breasts or instruct her on self examination? How about checking lymph nodes? Does the doctor listen to your heart and lungs through three or four layers of fabric because there isn't enough time (or professional interest) to have you take off your garments. Is the doctor (or other health care professional) sufficiently skilled in physical examination to be able to recognize an abnormality or is his or her professional continuing education dictated by the programs which insurers and pharmaceutical companies offer? Or does the doctor or other health care professional ignore the role of history and physical examination and believe that the only way to find disease is by lots of lab tests?

If no one looks, no one finds treatable pathology. If no one finds treatable pathology, the patient will probably change jobs, move to another insurer, and the first insurer or HMO will not be burdened with the costs of diagnosis and treatment. As the insured, you have fulfilled your duty of providing profit for the insurer or HMO and allowed the health care provider to see his or her allotted number of patients.

You may know a lot about football or baseball. In both sports there are rules and umpires. What are the rules governing the care you should be receiving and who is enforcing the rules? If you don't know the rules, you may be the loser.

Who Is Kidding Whom?

In the mid 1980s, I suggested that in twenty years we would have six major health care systems in the United States, in addition to government systems. We are pretty close to that number now, and the insurance/HMO/health care industry has opted to consolidate which makes their operations virtually indistinguishable in principle from Medicare. There is one major difference: with the exception of Medicare and the Permanente health care system, the others soak up a lot of dollars that should be used to purchase health care and divert those dollars to administrative overhead. One research study demonstrated that about twenty five percent of the premium dollar wasn't buying physician services, hospital services, ancillary services, preventive health services or the other items we recognize as health care - the twenty five percent of the premium dollar was buying clerks and offices and administrative salaries and generous payments to top executives, while business and the individual purchaser of insurance products were struggling to manage their own health care costs. If Medicare and Permanente can provide the range of health services that their beneficiaries/members need for near 3 percent of the health care dollar, and since the insurers and their subsidiaries have become large impersonal, inefficient, unfriendly and difficult to deal with, why don't we exercise some common sense and move to a single or near-single payer system - so that we can use health care dollars for health care and maybe even have some money left over to provide for the 47 million uninsured in America?

America and A La Carte Care

America's vast resources cannot provide unlimited health care under its current system. But America can afford and provide efficient, scientifically sound, compassionate and high quality health care which meets the needs of most of its citizens. Efficient, science-based, health care requires (at least): (i) elected officials who refuse to bend to political and financial pressures from the electorate, industry, entrepreneurs, insurers, the press, and other self-interested parties; (ii) an independent, adequately budgeted and funded federal agency which is shielded from political pressures, and given authority to approve or disapprove (on the basis of conflict of interest-free scientific consensus) public health measures, medical treatments and procedures for payment by payers; (iii) a conflict of interest-free medical profession which genuinely advocates for its patients, provides highly competent care which not only cures, but more importantly prevents disease, and abandons infighting with respect to "turf," financial reward, markers of competence and competition; (iv) a health care industry (including pharmaceutical manufacturers) which, instead of focusing on high management salaries and returns on investment, profits/surplus, prestige and control focuses on excellence and appropriateness of care and products/services and is then provided with sufficient financial support to preserve its capital base and generate reasonable profits; and (v) a public which accepts science as the basis for medical decision-making and payment and demands health care consistent with scientific medicine.

I am not optomistic that we will soon see such a system. There are too many interests lined-up at the health-care trough who now buy their way to the front of the line.

We've Squandered Our Resources for Health Care

If America believes that the November, 2008 national election will solve its health care system woes, it is delusional. Our current Republican administration is a bankruptcy government which won't leave enough assets in the treasury to pay for important domestic programs, and certainly not enough to support a national efficient and high quality health care system. Not only has our Republican government demonstrated that it is bankrupt morally, constitutionally, politically and financially, it has cynically squandered our resources in a manner it would condemn if it had been done by our citizenry. When politicians retire from federal office they enjoy first class health care benefits. If their illnesses require extensive care, they have the resources of the Federal government to provide for them through insurance. If the average citizen becomes ill and exhausts his personal insurance benefits and bank account, and then purchases health care using a credit card, and then becomes bankrupt, he or she will not be discharged from that credit card debt because credit card companies got the Republican Congress and Administration to bar discharge. The politician receives the care needed; the needy citizen and the citizen's family become financially broken by the health care system's costs and irresponsible Congresspeople and their financial institution supporters. Don't pin your family's health care hopes on election year promises: the promises can't be fulfilled.

Sage Advice

Years ago, a respected professor with a name similar to mine, told his house staff to ask the question "why is this bast... lying" when listening to academic presentations. Whether you are listening to (or reading a newspaper or magazine) to a drug company representative, an insurance company spokesperson, an academic, a politician or any person who pretends to have "the answer" which will fix our troubled health care system, keep the professor's question in mind. Be skeptical. A health care system which employes millions of persons, consumes about 16% of the gross domestic product, and spins off substantial profits to a variety of institutions and companies which have tight financially rewarding political connections, is not susceptible to a quick fix. To find out why they lie, follow the money.