Should drugmakers disclose all patient-level data and complete study reports from clinical trials? This has been an extremely controversial question for the past few years, but the topic has become unusually heated in recent weeks, thanks to a feisty medical journal, a provocative physician-cum-journalist and a belligerent trade group that represents the pharmaceutical industry.

Moreover, the issue has taken an unusual, if not bizarre twist after one of the largest drugmakers, GlaxoSmithKline, issued a statement in support of full disclosure just one day after the Pharmaceutical Research & Manufacturers of America (PhRMA) blasted the entire notion and slammed an online petition calling for drugmakers to open their vaults.

Debates over disclosing clinical trial data are not new, of course, but safety scandals over the past few years — notably, the Vioxx painkiller withdrawn by Merck and the Avandia diabetes pill marketed by Glaxo, both of which were linked to heart attacks and strokes — have galvanized a wide range of academics, physicians and patient advocates who want drugmakers to release the information.

The ensuing concerns over transparency and credibility last year prompted nearly two dozen medical journal editors and pharma executives to convene a roundtable to combat complaints about ghostwriting, the extent to which researchers are given full access to clinical trial data and perceptions that industry-sponsored research can be tainted, among other things.

The effort yielded 10 specific recommendations, including the release of all trial results, favorable or unfavorable, on a timely basis. However, the Medical Publishing Insights and Practices is a voluntary initiative. And the call for disclosing patient-level data and case study reports has, nonetheless, gained traction as a result of ongoing clashes between researchers and drugmakers.

One clash, in particular, has sparked outrage and frustration. In this case, there has been concern over the effectiveness of the Tamiflu influenza treatment sold by Roche.

An initial assessment by the Cochrane Collaboration found the medicine defended against the flu and other deadly conditions linked to the disease. But in a follow-up effort, the research group reversed itself and determined Tamiflu may not prevent complications from the flu in healthy adults and found no clear evidence for preventing lower respiratory tract infections. The researchers expressed concern that the EMA, which approved Tamiflu in Europe, only saw some trial results and the FDA is believed not to have reviewed the largest trial of Tamiflu when the medicine was being considered for approval.

Despite reassurances from Roche, the researchers were not provided all of the promised study data and complained publicly that they were stymied in their efforts to fully assess up-to-date efficacy information. More recent attempts to obtain data prompted a response from the drugmaker that critics described as stonewalling.

Last November, however, Roche offered to establish a multi-party advisory board to review all Tamiflu data. The board would consist of experts from academia and private institutions, who would then agree on which analyses were useful in assessing the appropriate role that Tamiflu should have in aiding public health. But so far, the Cochrane Collaboration researchers who questioned Tamiflu effectiveness and claim they were rebuffed in their efforts to obtain trial data have not relented.

In response to this unusually public battle, the British Medical Journal (BMJ) this year upped the ante by instituting a new policy in which the journal will no longer publish studies unless “the relevant anonymised patient level data available (is made available) on reasonable request.” And along with several advocacy groups, BMJ also launched an online petition called AllTrials that demands releasing all clinical trial data.

The cry was also taken up by Ben Goldcare, a physician and widely read newspaper columnist in the UK, who recently published a book called Bad Pharma, which, as the title suggests, takes the pharma industry to task for a number of controversies, including a reluctance to release trial data.

To what extent the petition will change corporate policy is unclear. As of mid-February, some 30,000 signatures were collected, but other than the weight of public opinion, even a few million signatures is not binding. Just the same, an online petition does allow advocates to find a way to keep the argument alive.

While all this was playing out, GSK vowed to forge a more cooperative path. In response to a $3 billion settlement that was reached last summer with the U.S. government for a series of infractions, the drugmaker agreed to take some unprecedented steps to address the issue of clinical trial disclosure.

Why? Between 2001 and 2007, GSK failed to include certain safety data about Avandia in reports to the FDA. The missing information included data from post-marketing studies, as well as data about two studies undertaken in response to European regulatory concerns about cardiovascular safety. GSK agreed to plead guilty to failing to report data to the FDA and to pay a $242.6 million criminal fine.

Last fall, GSK announced a new effort in a purported attempt to make amends. The plan is to publish case study reports for all of its medicines once they have been approved or discontinued from development and the results have been published. GSK will also publish reports for all approved medicines dating back to its formation, but confidential patient information will be removed, which means this piece of the process will likely take years.

In addition, GSK is creating an independent panel of experts that will review requests from outsider researchers who want to examine trial data. The approved requests will then be placed on a secure website. The names of the panel members have not yet been disclosed, although the drugmaker recently indicated an announcement will be made “in the near future”.

Thus, the stage was set for a clash. In early February, not long after BMJ instituted its new policy and helped to launch the AllTrials online petition, PhRMA lambasted both the journal and Dr. Goldacre in a harshly worded statement.

The trade group declared, “The demands by Dr. Goldacre and the British Medical Journal to release patient-level clinical trial data are irresponsible with potentially harmful consequences for future medicine development. The recommendations would jeopardize patient privacy and could serve as a deterrent to individuals considering participation in trials. It would also encourage second-guessing of the regulatory approval process, which would be disastrous for patients.”

Interestingly, there was no mention of GSK. Of course, since the drugmaker is a member of PhRMA, this was not surprising. Just the same, the divergent positions represent a rare public schism. The Association of British Pharmaceutical Industry is similarly opposed to releasing such information, but by contrast has been much more restrained in tone and substance.

To outsiders, the pharma industry may appear to be monolithic, but rivals often take differing views on topics. Generally, though, such strong differences are not so visibly public. The contrast was made all the more stark when GSK released its own statement just one day after PhRMA lobbed its attack and reiterated its commitment to releasing not only a slew of clinical trial data but, significantly, also backing the AllTrials campaign.

“All those involved in the conduct and publication of clinical research, whether healthcare companies like Glaxo, academia or research organizations, have a role to play in ensuring that the data they generate are made publicly available to help bring patient benefit,” said Patrick Vallance, who heads pharmaceutical R&D at GSK.

So what happens next? Clearly, many drugmakers remain reluctant to release certain data, but they maintain this position at their own peril. There have been too many safety scandals in recent years and, when coupled with spats over pricing and patent rights, the pharma industry has lost considerable good will and trust.

In fact, only 34% of 600 patient groups say that multinational drugmakers had an ‘excellent’ or ‘good’ reputation last year, according to Patient View, a research firm that conducted the survey. This compares with 42% in the 2011 survey of 500 patient groups. In general, 40% of the 600 patient groups believe industry reputation declined. One issue that contributed to the findings: a perceived lack of transparency, especially in reporting disappointing trial results.

Drugmakers can only expect additional pressure to release more information and would be wise to listen closely to the reasons for doing so. To appear recalcitrant will, in the end, be self-defeating. The GSK proposal may not prove to be a panacea, but if other drugmakers were to take the same step, they may be able to diffuse some of the criticism. But the sort of statement that was issued by PhRMA, even if there are legitimate concerns, does nothing to alleviate suspicion and mistrust.

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Ed Silverman is a prize-winning journalist who has covered the pharmaceutical industry for The Star-Ledger of New Jersey, one of the nation’s largest daily newspapers, for more than 12 years. Prior to joining The Star-Ledger, Ed spent six years at New York Newsday and previously worked at Investor’s Business Daily. Ed blogs about the drug industry at Pharmalot, at www.pharmalot.com. He can be reached at ed.silverman@comcast.net.