AllTrials
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 benefits 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.
ADDENDUM (21 August, 2015) - This post was republished on the Naked Capitalism blog.
4 comments:
To be fair, maybe it isn't really that newsworthy. Don't get me wrong: AllTrials is a great campaign and I agree that trial data should be made available. But, I've always understood that their campaign transcends borders. It has to, given the multinational nature of drug developers. Is it good that they are growing their US presence. Absolutely. Does it move the story along? Not much.
Anonymous of 11 August, 2015, 11:12 AM,
Well, many news releases by pharmaceutical and biotechnology companies get turned into at least small news stories. IMHO, this seems at least as newsworthy as many of those.
I think it's newsworthy, especially if you add in the part about the fact that large financial firms are now getting on board, too. But sometimes news coverage depends on timeliness and whether (US-based) reporters were given a heads-up so they could do a story on the day of the launch. Then once there's one media story, others try to cover it to keep up with the competition. But if they get wind of it a few days after the launch and no one else has covered it, they might figure it's a non-story.
We pitched op-eds on different aspects of the campaign by different authors ahead of release to a wide range of media outlets. All of them were rejected. We were told they weren't argumentative enough or "not right for us." In part, the European investor news of 3.8 trillion dollars of funds from the previous week generated an enormous amount of attention, including the Economist, so launching a week later in the US was probably seen as not being sufficiently different. In part, there is a massive amount of competition for op-ed placement; in part, reporting news of the launch of a campaign will induce editorial fretting over "PR" and there not being a news peg. The reality is that between the FT and the Economist, the campaign got some of the best news coverage ever—in fact, full throated endorsement from two leading journals. But that also tells you why many journalists will not cover it: too much of an elite issue. Either way, the campaign is just getting started.
Trevor Butterworth, Director, Sense About Science USA
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