Safety and Risks: March 2007 Archives

BOSTON, MA -- March 6, 2007 -- 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 and Brigham and Women's Hospital of laws and regulations governing public disclosure of clinical trial data submitted to the 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 current issue of Health Affairs.

"Although the current pharmacovigilance system is good and safe, there are now more countries in the EU, and therefore there is a need for an improved system," Ton Van Lierop, a Commission spokesperson told In-PharmaTechnologist.com.

The move comes hot on the heels of a consultation conducted by the Commission last year which found that that the current system is "contradictory, confusing, unclear and complex."

The feedback from the consultation suggested that there are complex reporting rules implemented differently by different EU member States, a lack of robust safety studies and complex decision-making at EU-level.

Abuse of prescription drugs is about to exceed the use of illicit street narcotics worldwide, and the shift has spawned a lethal new trade in counterfeit painkillers, sedatives and other medicines potent enough to kill, a global watchdog warned Wednesday.

Prescription drug abuse already has outstripped traditional illegal drugs such as heroin, cocaine and Ecstasy in parts of Europe, Africa and South Asia, the U.N.-affiliated International Narcotics Control Board said in its annual report for 2006.

In the United States alone, the abuse of painkillers, stimulants, tranquilizers and other prescription medications has gone beyond "practically all illicit drugs with the exception of cannabis," with users increasingly turning to them first, the Vienna-based group said.