Featured Research

from universities, journals, and other organizations

Taking The Wraps Off Drug Safety Data From Clinical Trials

Date:
March 20, 2007
Source:
Harvard School Of Public Health
Summary:
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.

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.

Related Articles


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 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.

Reference: “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.


Story Source:

The above story is based on materials provided by Harvard School Of Public Health. Note: Materials may be edited for content and length.


Cite This Page:

Harvard School Of Public Health. "Taking The Wraps Off Drug Safety Data From Clinical Trials." ScienceDaily. ScienceDaily, 20 March 2007. <www.sciencedaily.com/releases/2007/03/070320082329.htm>.
Harvard School Of Public Health. (2007, March 20). Taking The Wraps Off Drug Safety Data From Clinical Trials. ScienceDaily. Retrieved December 19, 2014 from www.sciencedaily.com/releases/2007/03/070320082329.htm
Harvard School Of Public Health. "Taking The Wraps Off Drug Safety Data From Clinical Trials." ScienceDaily. www.sciencedaily.com/releases/2007/03/070320082329.htm (accessed December 19, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Friday, December 19, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

The Best Tips to Curb Holiday Carbs

The Best Tips to Curb Holiday Carbs

Buzz60 (Dec. 19, 2014) It's hard to resist those delicious but fattening carbs we all crave during the winter months, but there are some ways to stay satisfied without consuming the extra calories. Vanessa Freeman (@VanessaFreeTV) has the details. Video provided by Buzz60
Powered by NewsLook.com
Sierra Leone Bikers Spread the Message to Fight Ebola

Sierra Leone Bikers Spread the Message to Fight Ebola

AFP (Dec. 19, 2014) More than 100 motorcyclists hit the road to spread awareness messages about Ebola. Nearly 7,000 people have now died from the virus, almost all of them in west Africa, according to the World Health Organization. Video provided by AFP
Powered by NewsLook.com
Researchers Test Colombian Village With High Alzheimer's Rates

Researchers Test Colombian Village With High Alzheimer's Rates

AFP (Dec. 19, 2014) In Yarumal, a village in N. Colombia, Alzheimer's has ravaged a disproportionately large number of families. A genetic "curse" that may pave the way for research on how to treat the disease that claims a new victim every four seconds. Duration: 02:42 Video provided by AFP
Powered by NewsLook.com
Double-Amputee Becomes First To Move Two Prosthetic Arms With His Mind

Double-Amputee Becomes First To Move Two Prosthetic Arms With His Mind

Buzz60 (Dec. 19, 2014) A double-amputee makes history by becoming the first person to wear and operate two prosthetic arms using only his mind. Jen Markham has the story. Video provided by Buzz60
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins