ALTERNATIVE DOCTOR, LLC
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ALTERNATIVE DOCTOR, LLC
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OP ED PIECE Drugs In America By Lloyd A. May MD
I walk into my medical office already a few minutes late, and walk in the back door. Usually, the first person I see is a nurse, or other employee. I turn the corner, and see standing there a pharmaceutical representative. On an average day, at least six separate pharmaceutical representatives barrage the doctors at our clinic with sales presentations on the latest drugs for depression, dyslipidemia, hypertension, and erectile dysfunction. They usually bring samples of these latest expensive drugs, invitations to dinner meetings at the best restaurants, conferences, and gifts. As soon as a drug goes “generic”-that is, cheaper for the patient- no more samples, no more drug representatives, no one marketing. I was starkly reminded of this fact last week, when the Pravachol representative, who had crammed my office full of Pravachol samples for years, didn’t mention it, as he marketed Plavix instead. I asked why-and he whispered back- “it’s generic now.” The kiss of death for a drug company-to lose a cash cow. The pharmaceutical industry is part of the medical industrial complex, consisting of physicians, hospitals, insurance companies, and pharmaceutical companies. Physicians are an indispensable cog in the machine which transforms the research and development of pharmaceuticals to prescriptions for patients. Pharmaceuticals, together with technology, have transformed healthcare since adoption of the scientific method by physicians in the early 1900’s. However, the pursuit of profit is now threatening the foundation of rational healthcare. The pharmaceutical industry spends an average of $40,000 per year per physician on direct physician marketing. Rather than objectively evaluating the best and most cost-effective therapy for each individual patient, many physicians reach for the “free” sample, which is not really free. Patients are initiated on therapy using the latest most expensive medicine-which may not even be the best-or the safest for them. A recent report showed that many required post-marketing safety studies are not being performed by the pharmaceutical industry. I have practiced medicine for over twenty years, and the list of drugs which were marketed as safe miracles, and later withdrawn, has multiplied. The recent example is Vioxx, which was extensively marketed to physicians and consumers alike, with a clear explanation of its known dangers. This was shown to me personally years ago, when I took a free antibiotic sample one Friday afternoon for a sinus infection. I took the pills for three days, returned to the office Monday, and received a telegram advising me it had been withdrawn from the market for hepatotoxicity. That left me with a personal distrust of the marketing hype all drugs come with, and the fact that any drug can be toxic. That is not to say that pharmaceuticals have not changed healthcare dramatically since the 1930’s. Drugs for infectious diseases, cardiovascular health, and vaccinations are truly life saving pharmaceuticals. However, it may be fitting to remember the FDA was only established after public outcry, over the deaths of 130 persons using a new drug in the 1930’s. Even today, regulation seems to be reactive, rather than proactive, such as the recent FDA surveillance program established post-Vioxx in 2005-the Drug Safety Oversight Board. And the public is to blame as well. As M.N.G. Duke mentioned in 1979, “the love-hate relationship which exists between the public and its drugs-substances which are hailed one moment as the solution to every problem, and castigated the next as the cause of every ill.” But even more unsettling is the fact that some drugs are approved, marketed, and prescribed, even if limited scientific evidence exists for their efficacy. For example, no twentieth century study of standardized antidepressant medication meets category A criteria for the treatment of bipolar depression! (Category A evidence is double blind placebo-controlled trials with adequate samples) That means that none of the fourteen or so of the commonly used medications for bipolar depression have proof of efficacy. Another example of the triumph of marketing over science is the phenomenal growth is the so-called SSRI’s. “Selective Serotonin Reuptake Inhibitor” is actually a marketing term, not a scientific explanation of what happens. But there is a problem with the serotonin hypothesis. “Not a single peer reviewed article supports claims of serotonin deficiency in any mental disorder,” scientists write in the December 2005 PloMedicine. And even more disturbing is the article by Dr Kirsch in the American Psychology Association review (2002). He reviewed efficacy data submitted to the FDA for approval of the six most widely prescribed antidepressants, Prozac, Paxil, Zoloft, Effexor, Serzone, and Celexa. He showed that if drug and placebo effects are additive, the pharmacologic effects of these antidepressants is clinically negligible! One recent morning, the counter in my back office was full of samples of Lipitor (a medication to lower cholesterol) and Triglide (a medication to lower triglycerides). Next to these samples were two dozen Krispy Kreme doughnuts. That display gave a snapshot of what is misaligned in medicine today. It is easy to see why Lipitor is the first 10 billion dollar sales drug, while our obesity epidemic rages unchecked. In conclusion, I have several suggestions: Patients need to ask questions of their physician: What is my diagnosis? What does the clinical evidence show is best therapy for my diagnosis? Are there any alternative treatments that are safe and effective? The drug you are prescribing-what are the side effects and risks? Are you prescribing the most cost-effective drug, or simply the last drug marketed to you? Physicians should adopt tough ethical standard dealing with pharmaceutical companies, such as that used at Kaiser Permanente; essentially, no free gifts, no drug samples. Physicians need to focus on delivering high quality error-free health care. Estimates of up to 100,000 persons die per year from medication errors alone. Physicians need to become as meticulous in safety as airline pilots. But physicians are paid to test, and to prescribe, not necessarily to be error free, so the error rate in diagnosis is high. Use of Category A evidence for all medical care is recommended when available. For a good review, see www.clinicalevidence.org Society needs to balance the private and public interest. Medicine now is only run as a business, but perhaps this is not the best model. In ancient China, physicians were not paid unless the patient improved. New not for profit initiatives need to be pursued, sponsoring drug development and distribution without the need for extensive and expensive marketing efforts. Finally, pharmaceutical companies should divert more of their marketing dollars to improving access to their drugs, and balance their need for profit with the requirement of being responsible citizens. Dr Lloyd A May Board Certified Internal Medicine, and Geriatrics May be reached at |
