Pharma & Biotech Trends - Compromise on Drug Data: T-R-A-N-S-P-A-R-E-N-C-Y is necessary

by John Sterling

In a recent trip to a European biotech conference I brought along a copy of Scientific American that was published last December. Among the articles that caught my eye was one entitled “Is Drug Research Trustworthy,” written by one Charles Seife. It provided the most recent look at an ongoing issue impacting the life sciences, i.e., the need for scientists to disclose who is funding their work.

Why? Because it’s in everyone’s interest to highlight any potential conflict of interest. For if pharma firms are spending big bucks supporting the research of independent scientists who, as the Sciam article noted, “are doing work that bears, directly or indirectly, on the drugs these firms are making and marketing,” and the scientists do not disclose this financial support, how are we to be truly comfortable with anything these researchers publish in a scientific journal? And what are we to make of a company’s product claims as a result of these alliances?

The Sciam article contained two very telling sentences:

“Researchers think that what these companies are after are their brains, but they’re really after their brand", says Marcia Angell, former editor in chief of the New England Journal of Medicine. "To buy a distinguished, senior academic researcher, the kind of person who speaks at meetings, who writes textbooks, who writes journal articles—that’s worth 100,000 salespeople".

I am not going so far as to say let’s ban all such financial support, but I do believe it makes a heck of a lot of sense to let everyone know what’s on the table. One step in the right direction was taken by the NIH several years ago. That institution mandates that NIH grantees disclose all financial agreements over $5,000 to their home organizations. But even here, according to Sciam, neither at the NIH nor at other scientific institutions are there regular “watchdogs” on the lookout for conflict-of-interest violations. So, it seems to me that transparency on who is doing what with whom and who is paying whom for what is the way to go.

And just when I got back from the European conference a story by Katie Thomas appeared in the NY Times: “Breaking the Seal on Drug Research.” Here again the topic of transparency was in the forefront, but this time the focus of the article was on strongly “encouraging” pharma companies to make public the data garnered in clinical trials for their products. The impetus behind these actions can be found in the severe side effects that were reported after some patients began taking Vioxx (heart attacks) and Paxil (increased risk of suicide among teenagers). Drug reform activists say that if more clinical trial information had been released earlier a number of these drug-related problems might have been spotted and serious adverse events avoided.

Sometimes the punishment for not reporting clinical trial safety data at all or doing so improperly can be harsh. In 2012, Glaxo paid $3 billion in fines after the U.S. Justice Department cited the firm for not reporting safety data on its Avandia diabetes drug (side effect was an elevated heart attack risk) and for publishing incomplete information on the previously mentioned Paxil.

The European Medicines Agency recently reported that next year it will make clinical trial data public whenever the organization approves a new drug. Roche and Glaxo are behind the EMEA on this. But the Pharmaceutical Researchers and Manufacturers of America trade group and other drug companies are not on board with this decision. They cite fear over the release of intellectual property information and other commercially protected data.

With people’s lives and well-being at stake, and with billions of pharmaceutical company dollars invested in drug research, there has to be room for some type of compromise, i.e., all involved parties need to come together to figure out a system where clinical trial data can be released earlier than usual with appropriate safeguards developed to protect valuable company information related to drug R&D and commercialization efforts. And, I contend, every effort should be made that as much transparency as possible be built into such systems.

Fuente: GEN