Model urges drug transparency

A Yale physician is fighting for greater transparency in drug development.

Harlan Krumholz ’80 , professor of cardiology at the Yale School of Medicine, furthered implementation of his medical model promoting transparency in the drug industry when he convinced the company Medtronic to adopt the program in August. Krumholz said his model encourages pharmaceutical companies to release all data from their clinical trials, in order to provide the medical community with the information necessary to evaluate drugs more accurately. Medical experts interviewed said widespread implementation of Krumholz’s program would enable physicians to choose the most effective medication with more confidence.

“Not all the evidence is in the public domain [and] it’s hard to make good decisions when you don’t have access to information,” Kruhmholz said. “To improve healthcare, we need to improve quality of information by increasing transparency.”

Pharmaceutical companies often release information selectively, he said, which results in biased data that can mislead the physicians who prescribe the drugs. He added that companies may choose not to release all of their information for various reasons. For instance, he said, they may believe parts of the results are not important, or they fear full disclosure will jeopardize sales.

Krumholz said he hopes to combat this problem by engaging in a dialogue with pharmaceutical companies to show them that releasing all of their data is actually an effective business strategy, as the best-selling drugs are those backed by the most scientific evidence.

This is not an easy task, Krumholz said, and many people he has spoken with expressed doubts that he will be able to persuade companies to be completely open with the public. But in early August, Krumholz persuaded the pharmaceutical company Medtronic to adopt his model.

Krumholz said he has been advocating for transparency in the pharmaceutical industry since the beginning of his career. In 2008, he publicly criticized the company Merck in the Journal of American Medicine for declining to release reliable information about their clinical trials of Vioxx, a drug for heart problems. As a result of Krumholz’s pressure, Merck was eventually forced to take Vioxx off the market.

The new influx of information resulting from Krumholz’ model will mean more debates within the medical community, he said, but the benefits will outweigh the costs.

“People are making decisions, so no data should be hidden from view,” he said. “Maybe all the data out there doesn’t change anything, but releasing information is the best way to know.”

Members of the health care community interviewed agreed that Krumholz’s system is necessary and, when implemented, efficient. Mary Warner, a physician and associate dean of the School of Medicine, said Krumholz’s proposal is feasible and all data from clinical trials should be available to the public after the drug in question is approved by the FDA.

“The proposal should be viewed as an opportunity to conduct a ‘peer review’ of the claims made by pharmaceutical companies,” Warner said. “Additional scrutiny of pharmaceutical clinical trial data furthers scientific inquiry and may improve safety considerations for our patients.”

Howard Forman, a physician and professor at the School of Public Health, said the project’s focus on transparency is critical because the current system seriously disadvantages both physicians and patients. Full disclosure policies ensure that the scientists evaluating the medications are unbiased by financial incentives, he said.

Krumholz is meeting with the CEOs of major pharmaceutical companies in Washington D.C. in December to discuss the benefits of transparency in their industry.

Comments

  • yalengineer

    *As a result of Krumholz’s pressure, Merck was eventually forced to take Vioxx off the market.*

    What?!? There are so many things wrong with that statement. Also Medtronic is not a pharmaceutical company.

    The issue at hand is not limited to drug companies. Even academics don’t publish all of their data from clinical trials, especially if they fail. The problem isn’t the unwillingness to disclose the data but rather, the general view in science that not everything (especially failures) should get published. Change the mentality of the publishing industry and everything else shall follow.