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What if we had an election and counted only half the ballots? When you’re burying research you’re also likely burying patients

Alan Cassels is a pharmaceutical policy researcher at the University of Victoria. He’s also one of our reviewers and a regular contributor to the blog.


Uncounted votes get attention. Why not unpublished drug trials?

Uncounted votes get attention. Why not unpublished drug trials?

As a group that aims to monitor and hopefully improve health news reporting, we sometimes notice what doesn’t make the news. Clearly the sexiest, most headline-generating and most tweetable topics come from reports of studies of “breakthrough” drugs and other “game-changing” therapies. Reporters love to feed these stories into the beast and the bigger the headlines the bigger the payoff in eyeballs and clicks. Throw in a celebrity or two—even one who is obviously flogging product for a drug company—and you’ve got a recipe for an avalanche of media attention.

Occasionally, however, there are the REALLY BIG stories that utterly fail to see the light of day. Consider the issue of the suppression of research, where as many as half the clinical trials on pharmaceuticals and other treatments have been buried from public view. How about the $374 billion we spend on drugs every year? It’s likely a large portion of it is being spent in blissful ignorance. People and organizations dedicated to uncovering and correcting this suppression agenda have come together under the AllTrials campaign which started in the UK a few years ago. The US arm was just launched at the end of July. Roy Poses, who penned a blog post in Healthcare Renewal, noticed the deafening media silence in the US around the campaign which calls for “every clinical trial, past, present, and future, to be registered and the results from it reported.”

Admittedly not a sexy topic and void of celebrity starpower, but the one thing the issue of research suppression has going for it, is that the issue is very well documented, including this study in the Lancet. The paper examines at least ten high-profile examples of suppressed research, the implications of which are mind-numbing: quite likely there are hundreds of thousands of patients affected and billions of dollars likely wasted around the world because we allow this kind of research fraud to continue.

This is a huge–and newsworthy–issue. Consider that when you’re facing off at your doctor’s office and the suggested treatment is a range of prescription possibilities, neither your doctor nor you could possibly have a full accounting of a drug’s risks and benefits. Because drug research and production is ultimately a commercial enterprise, a trial that shows a drug doesn’t work is less likely to be published (actually twice as likely to remain hidden than one reporting a positive result). If our doctors are only getting half the story, it’s likely their patients—and that means everyone of the pharmaceutical-consuming public—are likely misled about the possible adverse effects or side effects of their treatments.

So why would such a story not create any media attention? Poses suggests that this is such a colossal issue it likely challenges and rattles the power structures in US healthcare, so no one wants to talk about it. I agree, but there are other considerations: how research gets generated, reported and acted upon involves hundreds of decisions which are structural, scientific, political and, well, complicated. These issues are hard to summarize in a soundbite and without a Kardashian or an Angelina Jolie to pack a media-loving punch they slide to the bottom of the priority list.

I wonder if such reporting would improve if we had better analogies? Maybe the best way to express the gravity of what is happening is by comparing it to something that does have our interest: elections.

For example, what if we held an election and only reported the outcomes of half the ballots? asks Dr. Steve Woloshin, a physician at the Geisel School of Medicine at Dartmouth which is one of the co-founders of the US AllTrials campaign.

He further asks: “Imagine if the winner of the election was the one who decided which half of the voting was reported? That would be crazy, but that’s what the situation is when trials are not reported.”

Woloshin’s institution was one of 50 organizations, representing about half a million patients, doctors, and researchers in the United States, who helped launch the US AllTrials campaign. Aiming to “fix medicine and science,” the folks at AllTrials are asking for what seems a very simple and reasonable request: that if you are a drug company and going to go to the trouble of carrying out a clinical trial then you should register and report the full results. I can’t imagine people who volunteer for clinical trials would agree to participate if they knew their experience with a drug may never see the light of day because the manufacturer didn’t want people to know the drug causes peoples’ noses to fall off.

There’s an even more grave issue than hidden clinical trials – which received a little more media attention, in such places as the New York Times, Forbes, and the Los Angeles Times. It concerns the 21st Century Cures Act, and some have suggested that it’s going to radically rewrite the rules on the requirements for evidence to get drugs and devices approved. Trudy Lieberman’s recent post about the Act suggests something even more ominous: that we might as well do away with the need for clinical trials altogether!

What do we need to do to ensure that these BIG stories get the press they deserve? That’s a difficult question to answer, but perhaps Roy Poses has a place to start when he said: “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.”

It’s certainly not taboo to discuss rigged or fraudulent elections, so why can’t we discuss this majorly dysfunctional aspect of modern drug research?

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Comments (4)

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Adam Jacobs

August 19, 2015 at 9:43 am

“Consider the issue of the suppression of research, where as many as half the clinical trials on pharmaceuticals and other treatments have been buried from public view.”

That would be terrible if it were true. But happily, it isn’t. It may have been true in the past, and it’s certainly true that researchers in the 1980s were less likely to publish all their results than researchers are today. But the problems of incomplete publication have been quite well known for at least a decade now, and recent studies show that the vast majority of clinical trial data get to see the light of day.

Here’s a recent study that shows > 90% of trials sponsored by the pharmaceutical industry were published:

http://informahealthcare.com/doi/abs/10.1185/03007995.2015.1047749

    Alan Cassels

    August 19, 2015 at 11:23 am

    The Alltrials campaign’s best available review of the evidence from 2010 says that between 50% and 98% of trials are publishing results. Perhaps better than it was, but why would we accept only the ‘vast majority’ of clinical trial data seeing the light of day? As the campaign asks: “What could possibly make even 1% secrecy forgivable?”

      Adam Jacobs

      August 19, 2015 at 11:48 am

      Very true. Anything less than 100% disclosure is not good enough.
      BTW, that “best available review of the evidence from 2010” was published in 2010. Most of the evidence it reviews is from much earlier. The idea that only half of trials are published in recent years is, I’m afraid, not remotely evidence based.

John Tucker

August 21, 2015 at 2:38 pm

The problem with this type of analysis is that it is commonly assumed that a trial is a trial is a trial. In actuality, a disproportionate fraction of unpublished trials are small, early stage trials of approved drugs for which much larger phase 3 trials have been performed and published, or trials of drugs that have never been approved by any national regulatory authority or marketed in any country. For example, a widely cited BMJ survey of “large” trials (http://www.ncbi.nlm.nih.gov/pubmed/24169943) found that only 68% of industry trials had been published within 5 years. The article grandiously concludes that industry is “hiding data”, but an examination of the list of unpublished trials in the supplementary material shows that over 75% are trials of drugs that have never been approved or marketed. A 2015 paper concluded that 90% of registered clinical trials of EMA APPROVED drugs from 2012 were published within 12 months of approval. http://www.ncbi.nlm.nih.gov/pubmed/25942525