International Pharma Associations Lay Principles For Publishing Trial Data, Regardless Of Outcome

HONG KONG - Multinational pharmaceutical companies may start submitting for publication the results of more clinical trials, whether they are successful or not, as part of a new set of principles endorsed by industry associations around the world.

The voluntary move is part of the Joint Industry Position on the Publication of Clinical Trial Results in the Scientific Literature, approved June 10 by the International Federation of Pharmaceutical Manufacturers and Associations and three leading associations in Europe, Japan and the U.S.

The principles call on member companies and associations to commit to, at a minimum, submitting results of Phase III trials to peer reviewed journals even if the trial failed. The submissions should be made within 18 months at the latest but preferably within a year of a product being approved or a trial discontinued.

In a joint release, the IFPMA, the European Federation of Pharmaceutical Industries and Associations, the Japan Pharmaceutical Manufacturers Association and the Pharmaceutical Research and Manufacturers of America said "there are important public health benefits associated with making clinical trial results widely available."

In recent years the organizations have signed on to a number of joint positions regarding clinical trial disclosure (Also see "IFPMA Clinical Trials Disclosure Code Covers All Studies Of Life-Threatening Conditions" - Scrip, 11 Nov, 2009.).

Concerns over how much information pharmaceutical companies should disclose are long standing. Issues include the speed of the disclosures and the accuracy of the information companies make public - whether companies massage the data they publicly release to make the results more palatable.

During the last few years, the industry has been accused of hiding some information, said IFPMA spokesman Guy Willis. Several companies have already moved to publish results from all clinical data. What the joint principles do, said Willis, is "to a certain extent codify something that is already happening."

The issue skyrocketed to prominence in 2004, when Merck pulled its arthritis blockbuster Vioxx from the market after studies found increased risk of heart problems - including heart attacks and strokes - associated with the drug. U.S. FDA first approved the drug in 1999 and by the time it was pulled from the market some 84 million people around the world had used it.

What caused widespread concern, however, was the emergence of internal documents that suggested Merck scientists had had concerns of the side-effects of Vioxx for several years but that information was not widely disseminated.

In 2007, Merck spent $4.85 billion settling some 27,000 Vioxx lawsuits in the U.S.

In March, in a decision on the first such lawsuit outside the U.S., a judge in Australia found the drug "doubled the risk of heart attack" and said "it was not reasonably fit for the purpose of being used for the relief of arthritic pain."

A study published in 2008 by the online journal PLoS Medicine confirmed that pharmaceutical companies work hard to put a favorable tone in the clinical trial data they release.

The study - done by the University of California, San Francisco - compared data filed with FDA in 2001 and 2002 against clinical trials that had been published. The study found that one-quarter of the trials were never published. Trials with positive results were much more likely to see the light of day than those that fail.

FDA has been deciding whether it should respond to studies published in journals while those studies are a component of pending NDAs. A task force is in place to look at the issue, including the possibility of changing regulations and laws (Also see "FDA Ponders Whether To Publicly Discuss Pending NDAs And INDs; Should Agency Reply To Studies Published In Journals?" - Pink Sheet, 30 Nov, 2009.).

In the UK, IFPMA runs an online clinical trials portal that includes information about ongoing clinical trials. In the U.S., all trials are registered with the National Institutes of Health, which runs the Web site clinicaltrials.gov, which includes summaries of trial results.

The associations that signed off on the principles represent dozens of national and international research-based pharmaceutical companies. The principles should address some of the disclosure concerns through minimum requirements for submission.

However, noted Willis, while pharma companies may submit trial information for publication, it is up to the journals to publish or not.

"Submission is one thing, publication is another. [The principles] put the ball on the court of the publishers," said Willis.

- Alfred Romann ([email protected])