Déjà vu all over again
Posted by Henry Bauer on 2013/11/21
Many voices have been raised in many places for many years, about the many things that are badly wrong with drug-based medical practices.
Dozens of books by well informed individuals have exposed the nefarious actions of drug companies, the lack of appropriate regulations and oversight, the damaging prevalence of conflicts of interest, the inadequacy of clinical trials, the failure to monitor drug safety and efficacy following approval and marketing, the disastrously inappropriate use of biomarkers as purported surrogates for clinical condition and prognosis . . .
Yet nothing changes. Or rather, things keep getting worse because nothing changes, and they will continue to get worse unless drastic, revolutionary actions are somehow brought about. More dangerous drugs will be prescribed to more people, harming them physically and mentally at increasingly exorbitant financial cost.
There is no good evidence that statins are of any benefit, specifically that they stave off cardiovascular disease or stroke — as acknowledged in peer-reviewed articles and the Institute of Medicine 2010 report, Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease.
On the other hand, there is ample evidence that statins have very nasty “side” effects: mental confusion, loss of memory, weakening of muscles.
Nevertheless, august authorities continue to revise their “guidelines” and “recommendations” to increase the numbers of people being prescribed these harmful, benefit-lacking substances. The latest initiative would double the number of Americans buying statins:
“The number of Americans taking cholesterol-lowering statin drugs is set to double under new guidelines unveiled Tuesday by the American College of Cardiology and the American Heart Assn.
The goal of prescribing statins to as many as 70 million people is to reduce the incidence of heart attacks and strokes in the United States, not merely to get patient’s LDL cholesterol – the ‘bad’ kind that’s most closely linked to disease risk – into an ideal range, experts said.”
But the peer-reviewed literature does not support the notion that statins “reduce the incidence of heart attacks and strokes” .
These revised guidelines do benefit the drug companies, as Marcia Angell pointed out in the New York Times:
“The Bottom Line? Often the Drug Companies’
[A]s is often the case with specialty societies, the groups behind these new proposals, the American College of Cardiology and the American Heart Association, are heavily dependent on financial support by drug companies to support their meetings. Moreover, members of their guideline committees often work as paid consultants or speakers for companies whose sales will be affected by the guidelines. About half the members of the committee that wrote the cholesterol guidelines had financial ties to the makers of statins . . . .
Conflicts of interest are not just a matter of form; they do matter.
Another problem: Instead of targeting cholesterol levels, the new cardiac guidelines target all risk factors that together would predict at least a 7.5 percent chance of a heart attack or stroke in 10 years – including age, smoking and high blood pressure. Thus, you might be subject to statin treatment even if your ‘bad’ cholesterol is quite low.
But why take a drug designed to lower cholesterol if that’s not your problem? That seems nonsensical, unless there is very good evidence that statins have other, relevant effects. And that gets to the heart of the matter.
Far-reaching guidelines should be based on strong scientific evidence from randomized controlled clinical trials. Without it, all we have is the opinion of a group that, even though expert, has a financial conflict of interest.
The only sure benefit of doubling the market for statins is to the bottom line of the drug companies” [emphases added].
In this modern, “scientific” age, one believes any and all official pronouncements on matters of science and medicine at one’s peril; see Dogmatism in Science and Medicine as well as the many books about what’s wrong with present-day medicine.
The solution has to be systemic: the whole system of drug research and approval and monitoring and marketing and prescribing has to be drastically altered, because what’s wrong is systemic, it is not the fault of any identifiable individuals or groups.
Angell was quite right to point to conflicts of interest as a source of damage. But conflicts of interest are widely misunderstood: it’s generally assumed that conflicts of interest are harmful only if individual subject to them behave unethically by not resisting temptation. That’s a mistaken view (read the excellent discussion by Andrew Stark, Conflict of Interest in American Public Life, Harvard University Press, 2000).
Conflicts of interest exert a statistically significant effect even if no one deliberately does anything unethical. I’ve used before the example of doctors who have financial interests in clinical labs prescribing more lab tests than doctors who don’t have such financial interests. But it is perfectly possible that the belief in the value of lab tests came first, and the financial investment later, so that the financial conflict of interest is not responsible for increased prescribing of tests. Nevertheless, the conflict of interest shows that a bias exists toward more testing.
As to consultantships, research grants, and support for “medical education” by drug companies: The overriding effect is that there are congenial interactions among researchers, physicians, and drug-company personnel. Congenial interactions conduce to a sort of team feeling. Researchers and physicians come to regard drug-company personnel as nice people who are doing their jobs honestly and properly. That researchers and physicians with conflicts of interest associated with drug companies vote to approve drugs more often than people without those conflicts of interest merely reflects attitudes no more reprehensible than feeling like an integral part of an enterprise, being loyal to one’s group, “my country right or wrong” — attitudes that may be based on mistaken interpretations but that are in no way reprehensible, whereas it would be reprehensible to do for personal gain things understood to be bad.
Within drug companies, specialization of roles also means that bad things happen even though no individuals do bad things deliberately. Managers naturally ask researchers to work on projects that are likely to bring the largest sales. Those conducting clinical trials believe reasonably enough that researchers have good reason to think their product is likely to be beneficial. Marketing staff rely on the expertise of the scientific personnel and can be enthusiastic about selling the drugs. So bias pervades the system, always in the favor of drugs and against looking with determined skepticism into actual efficacy and safety. The result is that over the last two or three decades, “blockbuster” drugs have increasingly turned out to be harmful rather than beneficial: see a list in Wikipedia and pp. 238-42 in Dogmatism in Science and Medicine.
The evils of modern drug-based medical practice can only be undone by a thoroughgoing overhaul of the whole system, including — for a start — banning direct-to-consumer advertising of prescription drugs and the restricting of “accelerated approval” to what it was originally designed for, genuine life-threatening emergencies.