Side Effects

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A More Transparent Future

Why the latest move by the European Medicines Agency is worth cheering

It’s not often we can put “Big Pharma” and “greater transparency” in the same sentence. Last week, however, delivered some rare good news about the release of medicine data that has patient groups cheering. “From the beginning of next year,” Andrew Jack reports in the Financial Times, the European Medicines Agency—the European equivalent of the FDA—“will release all information about clinical studies submitted to it by organisations seeking authorisation for new treatments.”

The article in question, “Healthcare: Big Pharma, Big Data” (behind a subscription), argues that this development “stands to revolutionise the pharmaceutical industry in the months ahead.” For one thing, it lowers the risk that drug companies can hide, skew, or play down negative data. It means, in short, we’re likely to get a far-more balanced and comprehensive picture of pharmaceuticals and their side effects.

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Readers of this blog may recall earlier focus on the alarming amount of fabricated and cherry-picked data that was flooding medical journals, with drug companies widely reported to have turned to ghostwriting agencies to plant evidence about poorly performing products. In my book on the history and promotion of social anxiety disorder, I documented how one drug company withheld from doctors, authorities, and the public critical information about its spotty antidepressant. In "Lies, Damned Lies, and Medical Science," a hard-hitting exposé in the Atlantic Monthly, David H. Freedman stressed in 2010: "Much of what medical researchers conclude in their studies is misleading, exaggerated, or flat-out wrong.” “So why,” he went on, “are doctors still drawing upon misinformation in their everyday practice?"

Concerned and frustrated by comparable amounts of cherry-picking by European drug companies, Peter Gøtzsche and his University of Copenhagen colleague Anders Jørgensen got the ball rolling by writing the EMA “requesting details of clinical trials on which the agency based its decision to approve the weight-loss drugs Rimonabant and Orlistat.”

“They worried,” notes Jack in the Financial Times, “that the drug companies could be concealing the full results of their tests. By potentially exaggerating benefits and playing down side effects, they feared the risk both of harming patients and imposing unnecessary costs on the healthcare system. They sought full details of the protocols describing the trials, the results and the supportive underlying raw data of tests on each patient trying out the medicines.”

Drawing on extensive research and interviews, Jack’s article is well worth reading in full. He notes the “trepidation” U.S. drug companies are now feeling about the EMA’s decision to release its data—trepidation that has stretched to include two U.S. companies, AbbVie and InterMune, “suing the EMA in the EU’s general court in an attempt to prevent it releasing their drug trial data.” The concern is clearly that the EMA's decision doesn’t just put Europe ahead of the U.S. regarding openness, but that it will lead to similar or greater public and legal pressure for data Stateside.

Jack’s article quotes some voicing reasonable concern that the data could potentially be misused or misinterpreted, and that the degree of openness publicly expected of the drug companies might also have knock-on effects for certain medical trials, including for retaining patient anonymity. But with mechanisms available to address such concerns, it’s hard not to see the EMA’s move as anything but a massive gain for patients, health professionals, and everyone rightfully expecting reliable data about the medicines they use.

“In the long term,” Gøtzsche is quoted in the FT as saying, “the more we share the data, the more efficiently the drug companies will be able to develop new drugs, which will benefit everybody. We must leave the dark ages of secrecy that we have suffered for too long.”

christopherlane.org

Christopher Lane, Ph.D., teaches literature and intellectual history at Northwestern University and is the author of Shyness: How Normal Behavior Became a Sickness. more...

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