Yves here. This post conveys disturbing, if not entirely surprising, information.
If you recall our last cross post from Roy Poses of Health Care Renewal, it was about how a drug with dubious clinical trial data (way too many sites, way too many dropouts) and a very small natural customer base was nevertheless being touted as as the next blockbuster heart disease drug. Drugs marketed well beyond their proper targets have produced disasters like Vioxx.
Here, we learn how a successful initiative in the UK to obtain more registration and publication of clinical trial data has had its US launch utterly ignored, not simply the mainstream media but also the logical suspects in the medical trade press and scholarly journals. If that does not tell you how much the coverage of drugs is controlled by Big Pharma, nothing else does.
So what do we call this successful effort to put important information in a reporting black hole? In the past, I’ve applied the term “agnotology,” which Wikipedia defines as “study of culturally induced ignorance or doubt, particularly the publication of inaccurate or misleading scientific data.” Here what we have is what amounts to the suppression of information, analogous to what happens when Google or Facebook pretends that certain topics or sites don’t exist. For most practical purposes, they actually do cease to exist. Poses uses the term “anechoic effect,” which is presumably taken from anechoic chambers, which are designed to prevent the reflection of sound or other types of signals.
By Roy Poses, MD, Clinical Associate Professor of Medicine at Brown University, and the President of FIRM – the Foundation for Integrity and Responsibility in Medicine. Cross posted from the Health Care Renewal website
Every now and then, someone tries to persuade me how much more open discussion of various kinds of recent unpleasantness in health care has become in the US. I admit there has been more media attention to certain issues, but unfortunately must maintain that the issues most likely to be make those who profit the most from our current health care system uncomfortable remains anechoic. Now I have my latest example
AllTrials is a UK based organization that advocates for registration and public reporting of all clinical trials. AllTrials explains the reasons for this simply:
Clinical trials are the best way we have of testing whether a medicine is safe and effective. They can involve thousands of people, patients and healthy volunteers, and take years to complete.
Results from around half of all clinical trials remain hidden
Trials with negative results are twice as likely to remain unreported as those with positive results. This means that people who make decisions about medicines don’t have full information about the benefit and risks of treatments we use every day. Read our 8 page briefing note on missing trials here.
Thousands of clinical trials have never been publicly registered
There is no complete list of all clinical trials, so we don’t even know that some trials have taken place, never mind what was found in them.
The contributions of hundreds of thousands of patients are unused and unusable
Patients volunteer for clinical trials because they expect that what was found in the trial will be of use to doctors who make decisions about treatments and to researchers who are studying the condition. Trial participants have told us that the culture of secrecy around clinical trial reporting is a betrayal of their trust. Read their words here.
AllTrials has garnered considerable support in the UK.
On Health Care Renewal, we have been discussing the problem of suppressed clinical research for a long time, and have made similar arguments. Up to now, I have chosen not to post a lot about AllTrials because as a UK based movement, it was getting considerable press coverage in the UK, and garnering considerable support there. I did not think the movement needed what meager help a Health Care Renewal post would provide.
The Anechoic AllTrials USA Launch
But now, AllTrials has come to America. And it perhaps should not be a surprise that its advent on this side of the pond generated essentially no notice, particularly, no notice in the US mainstream media or in US scholarly health care and medical journals.
The announcement of the AllTrials US initiative appeared on the organization’s website, and on the Biomed Central blog.. A press release appeared on the PRNewswire. The American Academy of Family Practice (AAFP) announced its participation on its website. The move received support from a post on the PLoS Public Health Perspectives blog, and perhaps surprisingly, from the UK based Financial Times.
Otherwise, at least according to my web searching efforts, there has been silence. I found nothing in major media outlets, nothing in medical journals, and even nothing on the websites of the few US professional societies other than the AAFP that are listed as AllTrials USA supporters (that is, the American College of Obstetricians and Gynecologists, American College of Physicians and the American College of Chest Physicians).
The Anechoic Effect Continues
We have frequently discussed the anechoic effect, the phenomenon that information or discussion that could challenge or discomfit the powers that be in the US health care often generates no echoes. In effect, suppression of clinical research in itself is an example of the anechoic effect.
Why might even discussion that allows that clinical research might be suppressed invoke the cone of silence?
Looking at AllTrials literature may not be too helpful in providing an answer to this question. The AllTrials organization is adept at discussing the reasons that clinical trials should not be suppressed, but has been very diplomatic about why they actually are suppressed.
On the other hand, its seems logical that when clinical trials are sponsored by organizations, such as pharmaceutical, biotechnology and device companies, to assess their own products, company management might get strong incentives to ensure that such research ends up making their products look good. Sponsored research could be manipulated (in terms of the formal hypotheses it tests, its design, implmentation, and analysis) to increase the likelihood that the results would favor the sponsor. When all else fails, the sponsor could suppress research that fails to make its products look good. There is at least suggestive evidence that this occurs. For example, see the now classic study by Turner et al that showed that clinical research sponsored by pharmaceutical companies to assess their own antidepressants were much more likely to be published if the results favored their own products.
So I suspect that the management of many health care organizations, particularly but not exclusively pharmaceutical, biotechnology, and device companies may not be very comfortable discussing the problem of suppressed research, or with measures designed to uncover such research. Further, as we have discussed frequently, such companies have financial arrangements with individual health care professionals, health care academics, academic health care organizations, and a variety of other organizations such as medical societies and patient-advocacy groups. These arrangements can constitute individual and institutional conflicts of interest. It is not impossible that such financial relationships might influence such individuals and groups to want to avoid the topic of research suppression.
Yet it is striking that the important AllTrials USA initiative, an offshoot of an organization that has certainly got some attention in another English speaking country, has generated NO media or medical/ health care journal coverage in the US so far.
We cannot expect any real improvement in the dysfunctional US health care system while it still appears to be taboo to discuss many of its most dysfunctional aspects. True health care reform requires open and honest discussion of these issues, that is, we need real free speech and a real free press in health care.
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