Some of the biggest scandals in the pharmaceutical industry (think Vioxx and Avandia) have been about drug safety, and how much of the clinical trial data on prescription drugs—especially the negative stuff—is kept hidden.
Not surprisingly, some scientists, physicians, regulators, and patients have joined forces to push for all clinical-trial results, positive or negative, to be openly published. The big drugmakers could choose to join with them to dig deep and truly scrutinize all clinical trial data, not just the studies they want to publicize. It’s an opportunity to right their wrongs and rebuild the trust they’ve broken. Instead, embarrassingly, they have chosen to push back.
The industry, under pressure from its critics, has gone to work on drafting new rules around clinical trial openness. But instead of truly embracing the idea, they’ve come up with alternative guidelines that sound good, but are weak enough to allow them to keep on hiding clinical trial data whenever they see fit. And they’ve tried to scare patient groups with warnings about privacy.
Last week, The Guardian reported on a pharma industry memo that described a plan to enlist patient advocacy groups to fight against transparency in clinical trial data. The gist is that companies are trying to scare patients into thinking greater openness will lead to wide-scale misinterpretation of data, and false health scares.
This story of behind-the-scenes lobbying came to light just a few weeks after the European Medicines Agency, the key drug regulatory office in the European Union, published a long-awaited draft report for public consideration on its proposal for greater openness of clinical trial data. The proposal would allow independent scientists to conduct much more thorough reviews of the safety and effectiveness of drugs. As noted in the introduction to the report, there’s a strong scientific argument in favor of greater openness. “It will enable the wider scientific community to make use of detailed and high-quality clinical trial data to develop new knowledge in the interest of public health.”
Around the same time, industry trade groups came out with their own voluntary guidelines on clinical trial openness. The guidelines from the Pharmaceutical Research and Manufacturers of America (PHRMA), and the European Federation of Pharmaceutical Industries and Associations (EFPIA) are supposed to set a minimum bar for disclosure, which member companies can go beyond if they like. The guidelines, which you can read here, are scheduled to go into effect on Jan. 1.
So the industry says it’s all for greater transparency, and then runs a lobbying campaign to fight the transparency movement. That takes a lot of cynicism.
“There’s a transgression of trust here,” says Stephen Friend, a former Merck senior vice president and now the leader of a biological data-sharing nonprofit called Sage Bionetworks. “This is the opposite of what we thought Pharma was trying to do, which is build trust and try to be more open.”
Industry trade groups have long argued that companies need to keep most of their data proprietary for competitive reasons. They say companies would never invest the considerable time and money it takes to develop new drugs if someone could easily come along and copy the innovative work while a product is patent-protected. There is truth to that, and clearly some care needs to be taken with data releases to protect intellectual property rights. Nobody wants a system that discourages investment in R&D of new therapies.
But if you look at the industry’s proposed transparency guidelines, they are pitiful. There is no hard commitment in there to publish summary results of failed studies, or to release the patient-level data that is the basis for trial results.
Instead, the industry is proposing that it will set up its own scientific review boards to consider data requests from “qualified scientific and medical researchers” and to evaluate the “legitimacy of the research question,” according to the guidelines.
What does that mean? Will pharma companies release data only to people they perceive as friendly scientists, or those sponsored by its research grants? Or will companies fully comply with requests from independent scientific critics like Steve Nissen of the Cleveland Clinic or Tom Jefferson, a Cochrane Collaboration researcher who has battled with Roche over access to clinical trial data on the flu drug oseltamivir (Tamiflu)? Will the people on pharma’s scientific review boards consider their research questions legitimate?
The industry proposal also calls for providing “synopses” of clinical study reports (CSRs). That doesn’t go far enough, and it also allows pharma to gloss over or downplay unpleasant facts when it writes up said synopses.
It’s important that summary results of failed clinical trials are published in scientific literature. Nobody likes to fail, and it’s embarrassing for companies, but fellow scientists can’t learn from the failures if they remain hidden. In an industry with so much failure, learning from these cases would reduce R&D waste. And sharing the data is consistent with the best practices of science, which relies on rigorous independent validation of results to reach conclusions of truth.
Here’s how far the industry was willing to go on that score:
“All company-sponsored clinical trials should be considered for publication in the scientific literature irrespective of whether the results of the sponsors’ clinical trials are positive or negative.”
“Should be considered?” That sounds like nothing but lip service. Pharma should be making an unequivocal commitment to publish the summary results of all company-sponsored trials.
There are just too many restrictions, conditions, and half-hearted gauzy sentiments in these guidelines for them to be considered a step in the right direction.
It’s true that the guidelines only set a minimum bar for disclosure, and companies (GlaxoSmithKline, for one, has been a leader on this count) may choose to be more progressive with their disclosure policies. But that’s not going far enough. The industry should be working hard on finding ways to effectively anonymize clinical data to protect patient privacy, and then dump both patient-level and summary-level data into open databases in an automated fashion. By setting up their scientific committees, and deciding who is a “qualified” scientific applicant, pharma is acting like the fox watching the henhouse. That won’t rebuild the credibility they’ve lost, or inspire anyone’s trust.
The pharma industry, like many others, fears change. It needs to get over its fears, and start thinking more creatively. Is it possible that with greater openness, and sharing data among thousands of scientists in industry and academia, companies might gain new insights to help them break out of their R&D funk? Might it shorten drug development timelines, and steer money toward projects with a greater chance to succeed?
If you read the public statements of the industry, it looks like they aren’t even seriously considering that notion. A quote on the European pharma industry group’s website says:
“Through collaboration, we must find better ways to share data and new ways of working together. We must find a balance between when it is appropriate to share data and when it is not. After all, we will not be able to continue our work of bringing benefits to patients unless we are also able to derive suitable commercial return from our ideas.”–Neil Weir, Senior Vice of President of Discovery at UCB Pharma and member of EFPIA’s Research Directors Group.
Let me translate. First half: “The critics might be onto something.” Second half: “We have to keep doing business as usual.”
Things are changing. The Internet era demands openness. Individual patients, aware of the explosion of data coming from genomic research tools, are increasingly demanding access to their personal health data to make better choices about treatment and wellness. Companies in other industries are realizing the benefits of openness, and they’re gravitating to decision-making based analyzing open sets of “Big Data.” If the pharma industry wises up, it will not have to be dragged into the era of openness kicking and screaming. It will grab this opportunity to both fix its faulty R&D model and rebuild public trust.
It’s a moment in time that shouldn’t be wasted.
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