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.
Comments enabled at the request of the author
I learned a lot from this book
“Corporate Crime in the Pharmaceutical Industry – April, 1984
by John Braithwaite ”
“First published in 1984, this book examines corporate crime in the pharmaceutical industry. Based on extensive research, including interviews with 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala, the book is a major study of white-collar crime. Written in the 1980s, it covers topics such as international bribery and corruption, fraud in the testing of drugs and criminal negligence in the unsafe manufacturing of drugs. The author considers the implications of his findings for a range of strategies to control corporate crime, nationally and internationally.”
can’t find any reviews. but it’s very informative.
A more recent (2013) book on the topic that I haven’t yet read but plan to soon — it’s well reviewed on Amazon:
Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare by Peter C. Gotzsche
I think this post exemplifies a peculiar pathology of academics and doctors: to think that if you just stand up, to point out something simple that should be done to fix a problem, then everyone will listen and act.
The first prominent public call for trial registration in an academic paper was in 1986. The first prominent quantitative data on publication bias in clinical trials was 1980. Since then there have been dozens of cohort studies documenting this problem. Writing academic papers to document a problem is a necessary but not sufficient criterion for fixing it.
The reality is that the AllTrials.net campaign took a long period of highly energetic campaigning, both behind the scenes and in public, to deliver the support and progress we have seen in the UK and Europe. I think this letter sets out the tedious, onerous, slow legwork fairly well:
“The real day to day business of the AllTrials campaign is a grind. It is admin. It is bottomless. This is how change happens: endlessly setting up meetings and seminars around Europe and the States, hours on conference calls and webinars, days pouring over impenetrable policy positions and dull consultation documents, constant coordination with teams in the States and UK, and collaborators around the world, dreary travel for staff to spend 2 hours face to face persuading and befriending, unending phone calls, and more. As someone who sits on his arse writing academic papers – like the people I criticised in the previous paragraph – I am humbled to see AllTrials staff do real work. Their work, paid for by you, is the kind of stuff that cannot be done as a hobby. It has moved the campaign onto another level, and made this issue unignorable.”
We will see how the campaign goes in the US. I am optimistic, and I think we can gather positive support, and work, but that will depend on people who are reading this blog. Standing up once to point out the problem will definitely not be enough!
Anybody who wants to get in touch and help, we are not going away:
It would also be interesting to learn whether reported results from a trial are consistent with the original data.
In other areas it has occurred that an abstract or summary was written even before the research was done or results compiled.
As long as the patent system grants such massive rewards for exclusive drugs that are widespread, the entire system will be incentivized to deliver drugs to market whatever the means.
I am hopelessly naive here, but I would hope that physicians would be wary of prescribing medications without demonstrated efficacy. I appreciate that Roy Poses is writing blog posts like this so that doctors have encouragement to be more skeptical about what they are prescribing.
It’s becoming increasingly difficult for doctors to avoid falling into the prescription trap due I suspect to a combination of factors which include: Pharma collusion with insurance companies, suffocatingly pervasive atmosphere of soft bribes, and total lack of objective information.
I should add, the acceptance of medicine for profit, health business rather than health care, as a desirable ideology.
Excellent article. It’s good to know about AllTrials and the now ever more familiar suppression of media coverage. Of particular note is the suppression even in scientific journals. Scientific American fits the description; its relative silence on global warming comes to mind as does its silence on corruption of scientific inquiry (grants) as well as using PR buffoons such as David Pogue to pimp apologies for spying on citizens or other misuse of technology.
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.
Sadly, the list of all important topics that have the exact same requirements (open and honest discussion) and that are also being muffled into astounding silence is a long one. Scientific research is coming to stand for methodological inquiries into profit potential.
I love reading studies, cause I’m a dork. I’ve had medical professionals openly mock me for questioning or even pointing back to the studies. Multiple times, publicly and privately. Once for pointing out a common antacid caused cancer in almost all the rats after a year (95%, seriously.)
It’s part of the medical culture to not worry about these things and cash your cheque, and lash out at those that are seriously concerned about the future of the industry, and possibly Western medicine in general. We’re being melodramatic. lol
Seriously, we don’t require long term studies except in animals, companies regularly publish to prove their product then tell you to ignore half the results because it wasn’t a complete study, we no longer do a cost/benefit analysis before bringing drugs to market, and we now consider 40% a real success rate when that used to be cited as placebo or country medicine success rate. This is quackery, not medicine, and it WILL result in a collapse of trust.
Doctors, like everyone, are also susceptible to the ideology that profit is everything including the almighty measure of one’s intrinsic worth. And once that frame of mind takes over, it’s easy to accept the profit centric orientation of big Pharma as well as the general corporatization of medicine as a good thing.
Doctors who get with the plan tend to succeed handsomely and those who don’t tend to have a nasty uphill battle that just gets harder and this constant pressure ultimately means the familiar race to the bottom as in other domains.
Doctors, more than everyone, are also susceptible to the ideology that money is everything.
What do we believe Doctor’s have to learn while running up debts or $250,000 to $500,000?
Patient Care or Money, is everything?
Expanding the frame of reference a bit, there is a deep bias which is then compounded by the institutional layers. We tend to focus on the success stories, whether of successful individuals (7 Habits…), or companies, or 95% confidence intervals in the hard sciences. This undercuts the understanding of the unique conditions associated with those successes, when more understanding may be gained by looking at the common factors of the non-successes.
Given this bias surrounding our perception of success, while the 95% is usually taken as given without retesting, with a shotgun approach also producing random positives which can still be leveraged, and then on top of all that is active suppression by corporate executors, oh and regulatory capture… This effort is both necessary and doomed. I’ll suggest the soft spot is those subjects of the clinical trials who did not receive good effect. If their motivation is not only themselves but the advance of knowledge, it may only take a few going public with their lack of positive outcome to cascade of broader acknowledgement of the full breadth of the trials.
Publication of all trials and all data relating to trials is something that every man woman and child should agitate for. Every single news report about a study tends to obscure the truth and embrace press releases as scientific documents.
When people can, with only a little bit of extra reading, learn what the drug they or a relative are prescribed really does, we’ll perhaps enter a more reasonable world.
This is one of those things that we should spread around, to the best of our ability.
It’s sadly amusing to visit a middle age doctor and watch his or her resentment at your expectancy that they take your health more seriously than their profit. They can remember a time when a patient’s health above all was assumed throughout the medical community and you can almost trace the guilt on their studiously impassive face as they prescribe drugs you don’t need and skip mention of (expensive to insurance company) tests you do.
The degree our “free press” is now controlled by corporate/moneyed interest is truly stunning. I have followed the other side of this manipulation where tech corporate interests paid public and media relation firms to sell the false narrative of a “skilled labor shortage” — while half of the STEM graduates cannot find technical work, hundreds of thousands of professionals remain unemployed, and two of every three new IT job goes to a foreign guest worker. The techniques they deploy have been both scary and fascinating. While blocked, the tools and techniques deployed at the behest of these moneyed interests should be written as case study in propaganda and manipulation.
I have yet to separate whether they single out Washington DC for tighter controls/extra messaging or if lobbying and bribery make the difference. However, it is clear the echo chamber around DC is tightly controlled and nearly soundproof.
I’m glad this is getting some attention from blogs, if not from the big media organizations in this country.
One of the reasons why AllTrials might not have resonated in the USA is because we already have a clinical trial registry. It is “clinicaltrials.gov”.
Not to invalidate other criticism of drug trials. Just saying.
Sadly the FDA does not enforce use of clinicaltrials.gov
That’s one reason why I describe this legislation as a “fake fix” in my book on trials transparency and other problems (Bad Pharma).
Fake fixes give false reassurance and help people write blog comments like LAS above.
Regulatory capture again, eh? This is an old story, and one of several reasons I have Bad Pharma on my shelf is to get some validation on things that were major influences on my life’s path.
Memories of when I read a series of Science articles to my classes back about 1970 telling about the growing hexachlorophene concerns, the logical and increasingly alarming progression of studies generated, the evidence of brain damage in monkeys, and the cosmetic company exec who demanded and got a next-day appointment with the head of the FDA to demand that the Deputy Head be fired for calling for a warning label on a vaginal spray deodorant whose residue on mucous membranes was over 95% hexachlorophene once the solvent evaporated. And the bacteria of interest didn’t happen to be vulnerable to hexachlorophene. But it was a magic marketing word back then. Younger folks may not have seen this, but there was a time when hexachlorophene was a heavily advertised antibacterial ingredient in everything from mouthwash to chewing gum to shampoo. In every laboratory, people washed their hands with pHisohex. Me too.
But I wouldn’t have been a teacher if not for my exposure to a major pharma research department as my first job out of UCLA. The dominance of profit over every other motivation was palpable even to my young self. The company heroes were the salesmen, groups of whom won trips to Hawaii for their successes and were featured on page one of every issue (or so I remember it) of the company newsletter. Priorities were also clear from the relative status of the research lab senior chemists, 20-year veterans with the company some of them, and one of their cohort who went into management. And the VP who was on his way out, but was too high up the ladder to just be fired, so he got assigned to the nothingville of being VP i/c of research.
So even though I enjoyed the chemistry, it was back to school for me. And I’m glad I had the chance to do some good as a teacher. But I also remember the Science stories about the FDA guy in charge of approving vaccines, who was reprimanded when his tests showed that the swine flu vaccine that year was only about half as effective as claimed. He was instructed to stop devising tests, because his job was just to approve or disapprove a vaccine based on the paperwork submitted by the company. He finally got fired for trying to do the job that most of us citizens would have thought was why we paid our taxes to hire people like him.
So this latest campaign, 40-50 years after those times, is not likely to be any swift victory. I hope you’re dug in for the long haul and I wish you much success. To my mind, there are few causes more noble or important than awakening the public.
On the subject of Pharma one difference between the UK & the US is that commercial (i.e. consumer) advertising of medicines is heavily restricted by both UK & EU law. In effect direct to consumer advertising of prescription-only products is banned as are adverts for non-licensed medicines of any sort. Averts for non-prescription, but licensed medicines are heavily restricted in what that may say and how they may say it. A quick Google got me this reference:
So none of those sweet little movies of some 90 year old popping a Viagra then heading off to the bedroom …