GSK Opens Up Patient Clinical Trial Data for Review

GSK Opens Up Patient Clinical Trial Data for Review

October 12th, 2012 // 3:06 pm @

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In what may usher in a new era of transparency in the pharmaceutical industry, GlaxoSmithKline will make available patient-level data from its clinical trials to independent researchers, which means other scientists will have an opportunity to study the material and develop their own findings about safety and effectiveness. This also includes data for discontinued drugs.

“This initiative is a step towards the ultimate aim of the clinical research community developing a broader system where researchers will be able to access data from clinical trials conducted by different sponsors. GSK hopes the experience gained through this initiative will be of value in developing and catalysing this wider approach,” the drugmaker says in a statement.

The move comes after years of controversy over the extent to which drugmakers disclose clinical trial data. The pharmaceutical industry has long been criticized for failing to fully make underlying patient-level data available to others who seek to verify results. Drugmakers have insisted the data is proprietary, but critics have said the reluctance to disclose such information can be a red herring for hiding unflattering results that may limit sales.

The debate has factored into numerous scandals in which drugmakers have been accused of withholding important information about side effects. Glaxo, in particular, has been cited for such behavior with its Avandia drug, which figured prominently in a $3 billion settlement the drugmaker recently reached with the US Department of Justice for a number of infractions.

The feds claimed that, between 2001 and 2007, Glaxo failed to include certain safety data about Avandia in reports to the FDA. The missing info included data from post-marketing studies, as well as data about two studies undertaken in response to European regulatory concerns about cardiovascular safety. Glaxo agreed to plead guilty to failing to report data to the FDA and to pay a $242.6 million criminal fine (back story with the Avandia settlement agreement).

The implication from the announcement today suggests that Glaxo is attempting to turn learn from its mistakes. Right now, Glaxo posts summary data about each trial and shares the results on an accessible web site, which includes nearly 4,500 trial results. This came about after former New York State Attorney General Eliot Spitzer sued the drugmaker for not disclosing trial data that linked its Paxil antidepressant to suicidal ideation in children (back story).

That was followed by the Avandia scandal, which was triggered when the New England Journal of Medicine published a meta-analysis by Steve Nissen, who heads the cardiology department at the Cleveland Clinic. The ensuing flap led to the disclosure that Glaxo had provided concerning data about the drug and its link to heart problems to the FDA, but not on its own website, which made it impossible for other researchers to explore the issue.

Consequently, Glaxo has spent the past several years trying to live down the stain on its reputation. And so, going forward, the drugmaker is also committing to “seek publication of the results of all of its clinical trials that evaluate its medicines – regardless of what the results say – to peer-reviewed scientific journals.”

Nonetheless, the effort at transparency is being met with mixed results. Given the years-long battle to peel back the curtain on such data, some experts are hopeful the move will yield real results and prompt other drugmakers to make the same move. Although they are taking what can only be called and a wait-and-see approach to how this plays out.

“If they make good on this promise to openly share individual patient-level data with anyone who has a valid scientific question and provide the associated protocols and background information that is essential to make use of the data, then this is truly a day that may change all assumptions about what possible for a company to do,” Harlan Krumholz, a professor at the Yale Medical School and a board member of the Patient-Centered Outcomes Research Institute, writes us.

“GSK is saying that it is part of their business model to share data – advocates for open science have relentlessly made the point that sharing is in the company’s best interest – but here is the fifth-largest pharmaceutical company in the world voicing agreement and taking action. We will soon see if they are true to the spirit of sharing data. But the hope is that this move will spark change for all companies as they seek the same advantage that GSK has seized.

“Let’s see if policies to withhold data begin to fall and if the companies truly seek to make them a common good for society. Independent analyses of these data can provide many answers about the balance of risks and benefits for their products – particularly given that I expect that many studies have never been published and others only selectively published” (Krumholz recently wrote an op-ed about the topic, which you can read here).

Others, however, are not so sanguine and point to the language contained in the Glaxo statement. For instance, the drugmaker says that, “to ensure that this information will be used for valid scientific endeavour, researchers will submit requests which will be reviewed for scientific merit by an independent panel of experts and, where approved, access will be granted via a secure web site.”

One expert says this sort of gatekeeping role may yet add a barrier to complete access to data and lead to the same sort of problems that have occurred in the past. “This doesn’t sound like transparency to me,” Carl Elliott, a professor at the Center for Bioethics at the University of Minnesota, writes us. “It sounds like a PR tactic. If I suspect that researchers on a GSK-funded trial have rigged the design or cooked the data, is this ‘independent panel of experts’ going to give me access?”

This remains to be seen. Glaxo has not yet implemented the move, but the plan was announced this morning by Glaxo ceo Andrew Witty at a meeting with the Wellcome Trust, where he is also discussing details about opening up the Glaxo library of compounds for attacking malaria and tuberculosis. The drugmaker described this step as the first time that has taken such a step.

Will other drugmakers follow? This also remains unclear, but the pharmaceutical industry would do itself a favor by recognizing that such steps – even if imperfect and cause lingering skepticism about real improvements – are long overdue. For an industry that beats a loud drum about wanting to heal patients, the missteps over clinical trial data have done nothing but leave the public with a jaundiced view of its real mission.


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