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Pharmaceutical Companies Plan to Initiate Data Sharing with Independent Researchers

The New York Times reports that two major pharmaceutical organizations have developed guidelines to release manufacturer data on drugs to independent researchers. The Pharmaceutical Research and Manufacturers of America (PhRMA) and its complement, the European Federation of Pharmaceutical Industries and Associations encompass around 80 percent of global drug research.

Industry leaders have shown strong opposition to such disclosure in the past. In February 2013, PhRMA stated that releasing detailed clinical data would encourage distrust of regulatory agencies. For this reason, the recent pledge is seen by some as an effort to preempt more invasive data transparency requirements in the future.

Nonetheless, the recent announcement indicates progression in the industry, making independent research available to patients and doctors. Yale cardiologist, Dr. Harlan M. Krumholz, who has been calling for more transparency, said that “if these companies truly fulfill these promises, then they will have made an important contribution to science and the common good.” Rather than relying on manufacturer information, independent researchers will now be able to provide information on the associated risks and benefits of certain drugs.

The president and CEO of PhRMA encourages the recently approved plan as an alternative to the one proposed by the European Medicines Agency, which would make trial data public upon drug approval. The two trade groups have ardently discouraged this, claiming it would jeopardize patient privacy and allow competitors to gain an unfair advantage. Instead, their proposal will establish panels to consider requests from approved researchers for data release. The researchers would also be required to submit plans for the use of the data.

Although researchers doubt the independence of these panels, the PhRMA CEO confirms that “putting this out is what we think is a responsible way to meet the researchers’ needs.”