Merendeel medicijnen werkt niet en net die worden het hardst gepromoot*
Uit twee studies blijkt dat veel farmaceutische bedrijven meer met geld en marketing bezig zijn dan met het produceren van
medicijnen die doen waarvoor ze bedoeld zijn. Uit de eerste studie blijkt dat medicijnen die slechts voor een beperkte groep mensen werkzaam en veilig zouden kunnen zijn op grote schaal gepromoot worden bij de artsen om te bewerkstellen dat een grote groep mensen, veel groter dan noodzakelijk zou zijn, overgaat tot het innemen van die medicijnen. Hierbij worden veel mensen blootgesteld aan potentieel gevaarlijke medicijnen met alle mogelijke bijwerkingen. Uit de tweede studie stelt professor Light van de University of Medicine and Dentistry of New Jersey dat
bijna 85% van alle nieuwe medicijnen nauwelijks of geen werking hebben. In de marketing van deze medicijnen worden de voordelen flink aangedikt terwijl bijwerkingen achterwege gelaten worden. Aan marketingkosten van nieuwe medicijnen wordt tegenwoordig al twee tot drie keer meer uitgegeven dan aan researchkosten. Bij de aanvraag tot goedkeuring van een nieuw medicijn worden veel niet gewenste onderzoeken weggelaten en wordt met de andere onderzoeken vaak niet de goede werking onderbouwd en kunnen vragen gesteld worden bij ernstige bijwerking die mogelijk kunnen zijn.
Inverse Benefits Due to Drug Marketing Undermine Patient Safety and Public Health, Study Finds
Drugs that pharmaceutical companies market most aggressively to physicians and patients tend to offer less benefit and more harm to most patients -- a phenomenon described as the "inverse benefit law" in a paper from the University of Texas Medical Branch at Galveston.
Published in the American Journal of Public Health, the article explores recent withdrawals of blockbuster drugs due to safety concerns and finds a clear pattern of physician-focused marketing tactics that ultimately exposed patients to a worsening benefit-to-harm ratio. Potential patient safety and public health implications include unnecessary exposure to adverse side effects, high medical costs and competition for scarce resources.
"This is not a random occurrence, but rather a repeating, planned scenario in which drugs, discovered with good science for a specific set of patients, are marketed to a larger population as necessary, beneficial and safer than other alternatives," said co-author Dr. Howard Brody, a professor and director of the Institute for the Medical Humanities at UTMB Health. "Marketers are just doing their jobs. However, the reality is that for most new drugs, safety and efficacy are scientifically proven for only a small subset of patients. It's time for physicians to take a stand and not prescribe them so readily."
The inverse benefit law, coined by the authors and inspired by Hart's inverse care law (1), is manifested in marketing techniques commonly deployed to extend a drug's use beyond the proper evidence base. Brody and co-author Donald W. Light, a professor at the University of Medicine and Dentistry of New Jersey, identify these strategies and illustrate the "law" with recent examples:
· Guidelines that reduce diagnostic thresholds and rely on surrogate endpoints -- as seen in the steady lowering of blood glucose levels at which diabetes should be diagnosed to support glitazone drugs. Or relying on statins to lower cholesterol versus having a proven impact on the hard endpoint of decreasing heart disease incidence.
· Exaggerated safety and efficacy claims -- as many as 140,000 cases of serious coronary disease in the U.S. might have been caused by rofecoxib, a COX-2 inhibitor, that was broadly marketed as safer and more effective than standard nonsteroidal anti-inflammatory drugs.
· "Disease mongering" -- Osteopenia, once considered a non-disease state in patients who had not lost enough bone density to be diagnosed with osteoporosis, has now turned into a disease itself, in hopes of convincing physicians and patients that biphosphonate drug treatment will prevent their "disease" from progressing.
· Encouraging unapproved uses -- three of five prescriptions for antipsychotics are for off-label use, even though 75 percent of those prescriptions lack evidence of benefits but expose patients to harm. Recent examples include gabapentin and olanzapine.
"While we looked only at marketing directed toward physicians, direct-to-consumer advertising plays a critical role in driving demand for a drug by patients who fall outside the group that might truly need it, and pressuring physicians to prescribe it more readily," said Brody. "European countries are now debating whether to join the U.S. and New Zealand in allowing DTC advertising and we hope that our work could help inform that discussion."
Brody and Light recommend a series of remedial actions, including: restrict writing usage guidelines to groups free of commercial conflicts of interest; independently fund and design trials focused on safety and efficacy; and create a neutral agency (e.g., a branch of the National Institutes for Health) to conduct drug trials, including comparative effectiveness research to improve evidence-based prescribing.
The authors point to recent efforts such as the National Physicians Alliance's Unbranded Doctor Campaign and The Physician Payment Sunshine Act as positive steps toward a safe marketplace where physicians and patients access valuable, effective drugs.
"There is an unintended, but direct conflict between pharmaceutical marketing and public health," said Brody. "Physicians should approach commercial marketing by pharmaceutical companies with a critical eye. Future reform polices should look to reduce, minimize and limit these practices. Patients can also play an important role by being more skeptical of drug ads … and remember, the most important directive in them is to 'talk to your doctor'."
(1) Hart JT. The Inverse care law. Lancet. 1971;1 (7696); 405-412.
85% of Big Pharma's new drugs are "lemons" and pose health risks to users
For years, natural health proponents have been sounding the alarm about the dangers of new drugs being pushed on consumers. But is that a one-sided, inaccurate view? Not at all. In fact, new research now shows the problems with Big Pharma's hugely hyped medications are far worse than most people have even dreamed. Independent reviewers found that about 85 percent of new drugs offer few if any new benefits -- but they carry the risk of causing serious harm to users.
According to Donald Light, Ph.D., a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey who authored the study, the pharmaceutical industry is a "market for lemons" and Big Pharma spends a fortune to sell those lemons to the public.
"Sometimes drug companies hide or downplay information about serious side effects of new drugs and overstate the drugs' benefits," Dr. Light, who presented his findings in Atlanta at the 105th Annual Meeting of the American Sociological Association, said in a press statement. "Then, they spend two to three times more on marketing than on research to persuade doctors to prescribe these new drugs. Doctors may get misleading information and then misinform patients about the risks of a new drug. It's really a two-tier market for lemons."
Dr. Light's paper, Pharmaceuticals: A Two-Tier Market for Producing 'Lemons' and Serious Harm, is an institutional analysis of the pharmaceutical industry and how it works. He based his conclusions on a wide range of data from independent sources and studies, including the Canadian Patented Medicine Prices Review Board, the Food and Drug Administration, and Prescrire International (a French language journal which publishes extensive research on pharmacology, toxicology and pharmaceutics ). Much of research for the study was conducted for a forthcoming book Dr. Light edited, The Risk of Prescription Drugs, which is slated for publication this fall by Columbia University
Press.
In both his paper and his book, Dr. Light emphasizes what he dubs the "Risk Proliferation Syndrome", which refers to the way Big Pharma has grossly maximized the number of people exposed to new drugs with relatively low effectiveness but a heightened risk of adverse and often severe side effects. The pharmaceutical giants have accomplished this by failing to put each new medication on the market using a controlled, limited launch which would allow evidence to be gathered about the drug's effects, positive and negative. Instead, Big Pharma builds hugely hyped drug launches based on clinical trials that were designed in the first place to minimize evidence of harm and are published in the medical literature to only emphasize a drug's advantages.
Pharmaceutical companies spend millions of dollars on massive campaigns to sell a new prescription med, recruiting leading doctors to use the drug for conditions other than those for which it is approved, Dr. Light revealed. By promoting such off-label or unapproved uses, Big Pharma goes after even more sales and physicians inadvertently become what Dr. Light calls "double agents" -- they work to push sales of the new drug while they are supposed to be stewards of their
patients' well-being.
And what happens when patients complain that the drug is making them sicker and/or producing side effects? Studies show their doctors usually just discount or dismiss these complaints, Dr. Light said.
According to the new study, the big drug companies are successful in getting away with selling their "lemon" drugs because of three main reasons: Big Pharma is in charge of testing their own new drugs; the pharmaceutical companies have invested millions in building "firewalls" of legal protection to hide information about a drug's dangers or lack of effectiveness; and the bar for drug efficacy is set fairly low to make it easier for Big Pharma to get a new drug approved.
Dr. Light pointed out that despite the extensive requirements for testing the efficacy and safety of each new medication, drug companies use a strategy of "swamping the regulator" with large numbers of incomplete, partial, and substandard clinical trials. For instance, in one study of 111 final applications for approval, 42% lacked adequately randomized trials, 40% had flawed testing of dosages, 39% lacked evidence of clinical efficacy, and 49% raised concerns about serious adverse side effects.
"The result is that drugs get approved without anyone being able to know how effective they really are or how much serious harm they will cause," he said. "The companies control the making of scientific knowledge and then control which findings will go to the FDA or be published." (Februari 2011)
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