Boston, MA -- For years, pharmaceutical companies have sought to restrict public access to drug safety data collected in clinical trials on the basis that it is proprietary information, arguing that competitors could use that information in the development of their own products. However, a number of recent cases of drugs found to have dangerous side effects after coming to market, such as the anti-inflammatory drug rofecoxib (Vioxx), have raised concerns about safety data being treated as confidential. A new analysis by researchers at the Harvard School of Public Health (HSPH) and Brigham and Women's Hospital (BWH) of laws and regulations governing public disclosure of clinical trial data submitted to the Food and Drug Administration (FDA) suggests changes should be made to the way the FDA implements its policy regarding the confidentiality of those data. Allowing greater access to safety data would enable researchers to independently evaluate risks, resulting in more timely risk detection. The review and commentary appears in the March/April 2007 issue of Health Affairs.

"The Vioxx case and other drug safety cases have demonstrated the value of making these data available to researchers," said co-author Aaron Kesselheim, M.D., Department of Pharmacoepidemiology at BWH and an attorney.

Currently, pharmaceutical manufacturers submit clinical trial data, which establish the safety and efficacy of their products, to the FDA as part of the drug application process. However, after the agency approves a New Drug Application (NDA), it does not release a full report of the safety and efficacy data. Rather, it releases a summary of the clinical data section of the NDA (called the Summary Basis of Approval), and FDA regulations allow the drug manufacturer to draft the Summary. The process reflects an understanding by the FDA that safety and efficacy information should be protected, so that competing manufacturers can't use those data to develop generic alternatives or competing drugs.

Consumer groups have brought lawsuits against the FDA under the Freedom of Information Act to obtain safety data; these have had mixed results. Lawsuits are not an ideal vehicle for consumer groups and researchers to gain access to data, given that litigation is expensive and cases can take years to move through the legal system.

The commentary authors, Dr. Kesselheim and Michelle Mello, an associate professor of health policy and law at the HSPH, believe that making drug safety data public rarely presents a risk to a pharmaceutical company's confidential research and development efforts. "The legal question is whether the information will give other drug companies an unfair competitive advantage," said Mello. "But it is strange to argue that evidence that a drug is harmful will enable others to develop similar drugs." The authors suggest that current FDA policies can and should be changed in ways that allow the scientific community access to safety data before and after an NDA is approved. They offer a number of recommendations, including:

* Placing a heavier burden of proof on companies to show competitive harm if data are released.

* Replacing the current Summary Basis of Approval with a more comprehensive public document that includes all safety data.

* Getting Congress to pass legislation requiring public disclosure of safety data if the FDA fails to take action.

"Safety data from drug clinical trials have important ramifications for public health," said Kesselheim. "The government should do as much as it can to ensure full disclosure of the information."

Aaron Kesselheim's work is supported by a National Research Service Award to Brigham and Women's Hospital. Michelle Mello's work is supported by the Greenwall Faculty Scholars Program.

"Confidentiality Laws and Secrecy In Medical Research: Improving Public Access to Data On Drug Safety," Aaron S. Kesselheim, Michelle M. Mello, Health Affairs, Volume 26, Number 2.