Wednesday, May 28, 2008

Bisphenols, Endocrine Mimicry and Public Health

A number of years ago, when I was Chief of Staff and board member of a large hospital, hardly a month passed without my being approached by a representative of one of the vendors for intravenous solutions packaged in plastic bags. If you watch any of the television ER type programs, you have seen those bags (presumably made of different materials) prominently displayed dispensing television "life-saving" solutions and drugs.

The reason the representatives were on my doorstep is that I opposed the use of their plastic containers in the hospital. My understanding of the literature was that there was reason for serious concern about the plasticizers in these containers. I couldn't accede to their entreaties to be "reasonable." I did not want kids and sick adults exposed to materials which, the literature suggested, carried a long-term risk of harm.

On May 5, 2008, the Congressional Research Service published a report "Bisphenol A (BPA) in Plastics and Possible Human Health Effects (Order Code RS22869). The report summary notes "Some animal experiments have found that fetal and infant development may be harmed by small amounts of BPA, amounts to which many people may be exposed, but scientists disagree about the value of the animal studies for predicting harmful effects on people. . . . Legislation proposed in April 2008, S. 2928, would prohibit use of BPA in some products intended for use by children.

BPA is used in the manufacturing of hard plastics (polycarbonate) and epoxy resins used in food can linings. BPA is capable of migrating from the plastic into the foods or liquid with which it is in contact. BPA can mimick and otherwise interfere "with the action of estrogen, an important regular of reproduction and development." At levels to which many of us are exposed, in mice BPA may interfere with the development of the nervous system and prostate and mammary tissue.

Estrogen mimicry is a potentially major biologic hazard. Estrogens are involved in many developmental and other biologic functions, some of which are not obvious (i.e., provide receptors for certain bacteria). If investigation determines that BPAs are involved in urogenital, neurologic, endocrine, infectious or development abnormalities in humans, the result will be exposure of manufacturers of some consumer products to extraordinary liability. Plaintiffs' attorneys, who (with some justification) point to their roles in safeguarding public health, may extend their reach, prompted by professional obligations to pursue judgments for clients who have demonstrated significant levels of BPA in their bodies and the types of disorders that endocrine mimcry can product.

September 16, 2008 update link: "FDA defends plastic linked with health risks By RICARDO ALONSO-ZALDIVAR and LINDSEY TANNER Associated Press Writers.

Wednesday, May 21, 2008

Physicians Who Have AIDS

I am sometimes asked to recommend a physician. In my experience, physicians tend to recommend physicians who are in their peer group (similar age, training, medical school attended, residency or fellowship), and these recommendations are not always well-informed, current or appropriate. Sometimes they are downright dangerous.

My primary criterion for making a recommendation is whether the physician has good medical judgment. "Good hands" for a surgeon, an encyclopedic knowledge of disease for an internist, or good bedside manners for a family practitioner just don't make much of an impression on me. I have seen surgeons with good hands and technical ability operate inappropriately because of poor judgment. I have seen internists who could recite chapter and verse from the textbook who just didn't have the judgment to make important medical decisions, and I have seen good bedside manner cover up mistakes in judgmentwhich resulted in patient injury.

A physician's judgment may be difficult for a lay person or even a colleague to assess. Not only may it be affected by human frailties such as family problems, financial problems, lack of sleep, overwork and momentary distraction, it may be affected by disease. Physicians, with significant illnesses, including (but not limited to) Alzheimer's disease may become subtly demented so that even their working associates are not alerted to their dimished professional capacity. As I described in my chapter, "The HIV-Infected Health Care Worker" in West/The American Health Lawyers Association's) Health Law Practice Guide," there is increasing evidence that physicians who are infected with the HIV virus are at risk of having brain function impairment. They may have impaired neuropsychologic scores before treatment and after treatment with drugs which did not have maximum effectiveness. An excellent update on this subject can be found in Letendre,McCutchan et al. "Neurologic Complications of HIV Disease and Their Treatment" in Topics in HIV Medicine 16:15-22, 2008, a publication of the Intenational AIDS Society-USA.

Physicians and other health care workers have generally enjoyed confidentiality about their HIV status, primarily because there is no current significant evidence that they risk transmitting the disease to patients. Their practices may be restricted, with respect to certain invasive surgeries, but in general they practice without hindrance. It is time apply principles of public health to HIV-infected physicians and, because HIV-infected physicians may develop subtle dementia during the course of their disease, require routine periodic neuropsychologic testing. If significant impairment is found, practice should be restricted.

And it may be time to revisit the issue of notice to patients, since a physician who has significant neuropsychologic damage is not what the patient generally bargains for as a health care provider.

Sunday, May 18, 2008

See the Kaiser Foundation site for additional, though earlier, information concerning U.S. funding of the FDA for international inspections, heparin contamination and other relevant information: http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=51907 dated May 2, 2008.

Saturday, May 17, 2008

Are You Taking The Drugs You Think You Are?

Reasonably sophisticated patients don't order drugs from unknown vendors on the internet. Cautionary tales of counterfeit or adulterated drugs abound, and if one has a serious medical condition, that cheap internet drug may cause trouble, perhaps even death.

But what about the drugs you get from your local or mail order pharmacy? Aren't those drugs certain to be the genuine branded product or a generic bioequivalent?

If you attended law school, the police academy, are a regular viewer of one of the CSI series programs, or if you work for the United States Postal Service handling "Registered Mail" you have probably heard about the "chain of evidence" or "chain of custody." You know that for the chain to be valid, there must be specific contemporaneous written documentation of custody and transfer of custody at each and every step during which it is handled. You might make the assumption that there is a similar chain of evidence for the drugs delivered to you by your pharmacy (local or mail order) in accordance with your doctors' prescriptions. Sorry, this isn't CSI, law school, the Post Office, or a courtroom. If you want to see a puzzled, annoyed, look on your pharmacist's face, ask if he or she knows (and how he or she knows) where and by whom the drug sold to you was produced, whether there is documentation of each step and party in the distribution process, that the drugs you received were actually delivered and received by intermediate parties in the very same sealed containers as they were delivered in, and whether the pharmacist can guarantee that the drug that the pharmacy delivers to you is the genuine branded product or a bioequivalent generic. Unfortunately, our prescription drugs have been commoditized, and the handlers anonymized, so that our faith in the products we receive may be unfounded.

If enough people asked the questions I described, perhaps the distribution process would become transparent instead of opaque. Perhaps instances of expensive counterfeit drugs would be less common. Perhaps some of the drugs we take would help us, rather than hurt us. If you can't a responsible and responsive answer to the questions, contact your Congressperson.

My personal experience was that the FDA was totally unresponsive, even when there was a serious basis to believe that I had been provided with an inactive counterfeit drug. And by the way, the local branch of the chain pharmacy hadn't a clue to what was going on and had no interest in helping me find out when I returned the suspect drug to them.

Thursday, May 15, 2008

Who Sets The Standard of Medical Practice?

Commercial support of continuing medical education ("CME") is a widespread practice. Sometimes the sponsor links its name to the program or presenter. Sometimes, a calculated distance is maintained between the sponsor and the program by use of intermediaries or donation to a program "fund." In each case, the unspoken part is the commercial sponsor’s message, “we define the standard of care,” delivered by paid advocates through continuing medical education (CME).

"Sponsored education" is not restricted to physicians and other health care providers. The United States is unusual in that it permits direct advertising of pharmaceuticals (technically known as "dangerous drugs") to consumers. Like CME, consumer advertising implicitly dismisses physicians, who do not prescribe its product, as substandard and suggests that the consumer “find a better doctor.” Some CME speakers talk about the “efficiency” of prescribing the drug they are touting that day, but their real message (often couched as biased interpretations of flawed research) is that failure to prescribe or use the commercial supporter’s branded product means that the physician does not meet generally accepted standards of care and is inferior.

Defensive medicine is not limited to ordering unnecessary X-rays, tests and procedures. The subtle message of commercially sponsored CME, “meet the standard of care by prescribing our products,” keys into physicians’ fears of malpractice lawsuits, adverse peer review, and action by state medical boards. The results are defensive, unnecessary, costly and sometimes dangerous prescriptions and orders. The subtle message adds to our health care deficit.

Patients, the public, and our professions are paying a dear price for that free meal, lecture, slide show and hour of CME credit. Patients are taught to depend on pharmaceutical company advertising and to distrust their physicians and other health care providers. I believe it is time to terminate the destructive franchise we have given to commercial supporters of CME and direct consumer pharmaceutical advertising.

Wednesday, May 14, 2008

FDA Seeks Funding for Inspecting Foreign Products

The New York Times caption at page A13, May 14, 2008, provocatively reads "F.D.A. Chief Writes Congress for Money." The F.D.A. request may provide insight into Congress' willingness to solve serious American health system problems.

Contaminated human food, drugs (most recently heparin), and other related health products (including pet food) from foreign sources have become a major threat to Americans' health. The article notes that the request for $275 million went to Senator Arlen Spector, who had previously written to FDA Commissioner von Eschenbach asking how much money the F.D.A required to protect the public health, and outlined a spending plan which included opening new foreign offices, increasing inspections and constructing new databases to follow drug hazards.

Perhaps Congress will obtain a verifying Congressional Budget Office estimate of the actual amount the F.D.A. needs to do its job (meeting the agenda which Congress has set for it) since, even with von Eschenbach's apparent assertion of independence from Administration budget priorities, it is not clear how much of an infusion is necessary on an ongoing basis. Perhaps, too, Congress will appropriately fund the F.D.A. on a regular basis rather than provide it with legislative mandates which cannot be carried out because of inadequate and politically cynical Congressional funding.

The resolution of this issue will affect the health safety of Americans. Once the spotlight of the 2008 national election has been turned-off, we should keep on eye on our Representatives' and Senators' votes and monitor the new Administration spendable funding for the F.D.A.. In an environment of financial crisis, Congress and political leadership, like old dogs, may prefer their old tricks.

Sunday, May 11, 2008

Clinical Competence or Electronic Medical Records?

It may seem unfair to ask: "do you favor clinical competence over electronic medical records"? But today, the United States doesn't have enough dollars to pay for health care for its entire population. Use of billions of dollars of scarce resources to pay for electronic medical records systems will divert money from training competent clinicians in evidence-based medicine and may have a detrimental effect on health care.

Pysician, nurse, and nurse practitioner training programs stress the mantra: show us the evidence for the diagnosis you make and the treatment you prescribe. Unfortunately, health systems administrators, insurers, politicians and others who control the flow of health care dollars are not required to show solid evidence supporting their rush to electronic medical records. The information technology industry claims superiority for its products. Politicians, bureaucrats and administrators wax enthusiastic about their chance to spend billions of dollars on technology which does not yet demonstrate patient health outcome superiority as compared to traditional paper records and systems. The issue isn't whether a computer generates a pretty report for a mid-level administrator; it is whether the patient lives or dies or suffers severe medically unnecessary complications or pain.

Citing two studies of handheld electronic medical record systems, a 2006 Canadian abstract did not find conclusive evidence of a net benefit from the use of the handheld medical record system. It did report an increase in the number of wrong or redundant diagnoses (http://www.biomedcentral.com/1472-6947/6/26/abstract downloaded 5/11/2008).

Crosson and others reported the effects of electronic medical records on diabetes care in an NIH funded study (http://www.annfammed.org/cgi/content/full/5/3/209 downloaded 5.11.2008). Statistical analyses demonstrated no evidence of an improvement in ultimate outcome. Surprisingly ". . . . patients with diabetes in practices that did not have an EMR were significantly more likely to have received care that met the guidelines for processes of care, treatment, and intermediate outcomes".

There is literature claiming that electronic medical records systems show a good return on investment (http://www.medicalnewstoday.com/articles/76786.php downloaded 5/11/2008). Where are comparable studies demonstrating that the money spent for such expensive systems show a net benefit to patient outcomes. Where is the answer to the mantra: show us the evidence?

Wednesday, May 7, 2008

Res Ipsa Loquitor (for all you tort lawyers)

Institutional conflict of interest among physicians who treat Lyme disease, about Lyme disease and its treatment? After looking at Hilary Waldman's article in the Hartford Courant (5/2/08),“Agreement is reached on Lyme disease, http://.courant.com/news/health/hc-ctlyme0502.artmay02,0,5245299.story, take a look at the agreement between the State of Connecticut and the Infectious Diseases Society of America at
http://www.ct.gov/ag/lib/ag/health/idsaagreement.pdf.

It's enough to make you sick!

Sunday, May 4, 2008

Olympics, China, Hand Foot & Mouth Disease

With the beginning of the Olympic games in China, days away, the outbreak of hand, foot and mouth disease ("HFMD") in that country, with associated childrens' deaths, is a cause for some concern. If visitors from the United States are exposed to the virus and bring it back to the US with them, there is a risk of an epidemic which may further test our already stressed health system.

Hand, foot and mouth disease, a highly infectious and easily spread viral disease, is causing death among Chinese children and is beginning to spread among children in Vietnam and Singapore, as well http://www.breitbart.com/article.php?id=2008-05-04_D90ETD5G1&show_article=1&cat=breaking. HFMD may be caused by either a coxackie virus A16 or EV71. EV71 may also cause viral meningitis and, rarely, more serious diseases, such as encephalitis, or a poliomyelitis-like paralysis. EV71 encephalitis may be fatal. Cases of fatal encephalitis occurred during outbreaks of HFMD in Malaysia in 1997 and in Taiwan in 1998.EV71 encephalitis may be fatal. http://www.cdc.gov/ncidod/eid/vol9no1/02-0112.htm

According to the CDC, hand, foot, and mouth disease (HFMD) is a common illness of infants and children which is characterized by fever, sores in the mouth, and a rash with blisters. It begins with a mild fever, poor appetite, malaise ("feeling sick"), and frequently a sore throat. Then, one or 2 days after the fever begins, painful sores develop in the mouth which begin as small red spots that blister and then often become ulcers. They are usually located on the tongue, gums, and inside of the cheeks. The skin rash develops over 1 to 2 days with flat or raised red spots, some with blisters. The rash does not itch, and it is usually located on the palms of the hands and soles of the feet. It may also appear on the buttocks. A person with HFMD may have only the rash or the mouth ulcers. http://www.cdc.gov/ncidod/dvrd/revb/enterovirus/hfhf.htm

According to the CDC, HFMD is moderately contagious. Infection is spread from person to person by direct contact with nose and throat discharges, saliva, fluid from blisters, or the stool of infected persons. A person is most contagious during the first week of the illness. HFMD is not transmitted to or from pets or other animals.

No specific treatment is available for this or other enterovirus infections. Symptomatic treatment is given to provide relief from fever, aches, or pain from the mouth ulcers.

Thursday, May 1, 2008

Genetic Information Nondiscrimination Act Passed

This afternoon, May 1, 2008, the House of Representatives approved the Senate-passed version of the Genetic Information Nondiscrimination Act (GINA) (H.R. 493) by a vote of 414 to 1. The President is expected to sign the Act.

The American Society of Hematology, which advocated for the Act, noted in its release May 1, 2008:"GINA will prohibit health insurers from using individuals' genetic information to deny coverage or determine rates or premiums. In addition, the bill would bar employers from using individuals' genetic information when making hiring, firing, job placement, or promotion decisions."


For coverage of the Senate passed genetic antidiscrimination act, see:
Chicago Tribune April 25, 2008 article by Judith Graham, Tribune Reporter:
http://www.chicagotribune.com/features/lifestyle/health/chi-genetic-discrimination_25apr25,1,4203765.story

Also see Kaiser's: http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=51751

To read the text (110 pages): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_bills&docid=f:h493eas.txt.pdf