Milwaukee Journal Sentinel
October 25, 2013
An international push to get drug companies to share patient-level data from their clinical trials got another shot in the arm Monday with the publishing of two papers in the New England Journal of Medicine.
For years, pharmaceutical industry reformers have said drug companies should be required to release individual patient dataŚwith protections to preserve privacyŚas means to ensure more transparency about the true safety and effectiveness of treatments.
From the pain drug Vioxx to the diabetes drug Avandia to the spine product Infuse, they point to a growing number of controversies in which concealed clinical trial data prevented the true safety of products from becoming known until years after they got onto the market.
A 2010 investigation by the Journal Sentinel raised similar questions about a clinical trial involving the heart drug Multaq. Authors of a paper about the research, including a University of Wisconsin doctor, allowed their names to be put on the paper without getting access to all the data.
At the same time, reformers say up to half of all clinical trials are not published. Monday, two online perspectives in the New England Journal of Medicine added to the chorus of calls for more information-sharing as medicine enters the new world of "big data."
"The question is not whether but how these data should be broadly shared," wrote a group of U.S. academics, consulting company officials and a representative of the Pharmaceutical Research and Manufacturers of America.
They laid out four different models for releasing data, ranging from a widely open approach to one in which the trial sponsor reviews requests for data and makes decisions that can be appealed. They listed numerous potential benefits to the public, the scientific community, regulators and even drug company sponsors of clinical trials.
Those include increasing surveillance of drug safety and effectiveness, improving public confidence of treatments and the drug industry, and prompting of more secondary research that may answer new scientific questions.
They said privacy risks to patients and proprietary concerns of drug companies must be "thoughtfully addressed" in the new datasharing system of the future, but those concerns should not block progress.
"A managed-release environment that allows sharing of patient-level data while ensuring patient privacy would create a level playing field for all stakeholders," wrote four officials from the European Medicines Agency in London in a second paper.
They acknowledged drug company concerns that disclosure of trade secrets and proprietary information would allow competitors to "free ride" off of their innovation.
However, they said release of patient-level clinical trial data actually will benefit the drug industry by increasing efficiency of drug development and reducing the duplication of efforts.
As a researcher who has looked into Food and Drug Administration approval of medical devices, Rita Redberg has made Freedom of Information Act requests of the agency only to get back highly redacted records saying the data was proprietary information.
The agency added that its response was part of its "transparency initiative," she said.
"It's a joke," said Redberg, a professor of medicine at the University of California, San Francisco and editor of JAMA Internal Medicine/i>. Redberg was not involved in the two New England Journal of Medicine papers. She said devices often are approved based on shortterm clinical trials with a provision that companies do longer term trials after they get on the market. Yet the FDA won't release the complete data from those studies, she said.
"It's very hard to know as a clinician what's going on," she said. "It's hard for me to take good care of patients if I don't know the risks and benefits of various therapies." Beyond that, requiring the release of patient-level data will advance science because it will help drug companies avoid repeating the mistakes of others. It also will improve the quality of papers appearing in medical journals, she said.
One of the reasons people agree to be in clinical trials is to benefit society, said Harlan Krumholz, a professor of medicine at Yale School of Medicine and leading advocate for the sharing of clinical trial data.
"People participate to try to help the next person," he said. "It is only natural that we should reward their faith in us. You've made an investment in research. Why not try to get the most out of it?" Krumholz was not involved in the two New England Journal of Medicine papers.
He did oversee two independent research groups that analyzed clinical trial data, including patient information, involving Medtronic's Infuse spine surgery product. Medtronic funded the independent analyses after concerns were raised about papers written by company-financed authors who failed to properly warn of complications.
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