Representatives of the world’s biggest pharmaceutical companies pledged on Wednesday to release detailed data about their drugs to outside researchers, a move that was applauded by some but also seen as an effort to head off more extensive disclosure requirements that are under review in Europe.
The announcement, made jointly by the two major pharmaceutical trade groups in the United States and Europe, signals a shift for the industry, which in the past has resisted calls to systematically share its data. The proposal was unanimously approved by member companies and is to take effect on Jan. 1. It would apply to all new drugs and all new uses for existing drugs, whether approved in the United States or the European Union.
“Quite frankly, we recognize that there are a lot of skeptics, but this is the right thing to do and the right time to do it,” said John J. Castellani, chief executive of the Pharmaceutical Research and Manufacturers of America, also known as PhRMA, which developed the guidelines with its overseas counterpart, the European Federation of Pharmaceutical Industries and Associations. Members of the two groups collectively represent about 80 percent of the world’s pharmaceutical research, Mr. Castellani said.
“What they are doing would have been thought to be inconceivable even a short time ago,” said Dr. Harlan M. Krumholz, a cardiologist at Yale who recently oversaw an outside review of a treatment by the device maker Medtronic. “If these companies truly fulfill these promises, then they will have made an important contribution to science and the common good.” But he said their efforts would need to be monitored.
Proponents say doctors and patients need independent information — not just that provided by manufacturers — about the risks and benefits of drugs.
But as recently as February, PhRMA issued a statement criticizing proponents of data sharing, saying that releasing what’s known as “patient-level” clinical data would be irresponsible and encourage second-guessing of regulatory agencies, “which would be disastrous for patients.” Both industry groups have opposed a plan by the European Medicines Agency, which oversees approvals in Europe, to make trial data public whenever a drug is approved. A similar effort to require such data disclosure is under way in the European Parliament. On Monday, the British newspaper The Guardian reported on a leaked e-mail that detailed plans by the two trade groups to enlist the help of patient groups to try to kill the efforts in Europe.
Mr. Castellani said the plan released Wednesday should be seen as an alternative to the proposals being considered in Europe, which would have fewer restrictions on the data. Drug makers have raised concerns that patient privacy could be compromised if the data were not properly redacted, and that competitors could mine the documents to gain an advantage. Under the industry plan, companies would set up outside panels to consider requests from “qualified” researchers for a range of data and dossiers that drug companies keep on their drugs. They would also have to provide plans for how they planned to use the data.
Some researchers questioned whether the companies’ review boards would be truly independent, and bristled at what they described as restrictive requirements. But Mr. Castellani said such provisions were necessary. “Putting this out is what we think is a responsible way to meet the researchers’ needs,” he said.
Article source: http://www.nytimes.com/2013/07/25/business/drug-companies-promise-more-data-transparency.html?partner=rss&emc=rss
