Pfizer gets transparent on Phase IV trials
the status of its US post-marketing (Phase IV) drug studies
accessible to the public.
The pharma giant launched last week a website that provides study descriptions and status of post-marketing commitments (PMCs) current due dates, total listed PMCs, and general information about the PMC process. It is now available at www.pfizer.com/pmc and the information available online will be updated on a weekly basis, the company said. "The new Pfizer site expands the information available, presented with user-friendly search functions, a glossary of terms, and frequently asked questions about PMCs," the company said in a statement. Anybody looking for more information on the company's trials results can view the company's Phase IV for prescription drugs by product names, approval date and study status, among other criteria. As part of the Food and Drug Administration (FDA) regulatory approval process for new drugs, pharma firms may be required to conduct additional clinical trials and testing to support the safety and effectiveness of their new medicines. These studies are referred to as post-marketing commitments. However, 65 per cent of the Phase IV safety studies that pharma companies agree to conduct as a condition of approval of a new drug are not being completed, or are still "pending", according to an FDA report released last year. This is worrying because many drug-safety researchers believe that appropriately conducted post-marketing studies of Vioxx (rofecoxib) would have revealed its cardiovascular toxicity in some people "well before the end of its five-year run," Dr Jerry Avorn, wrote in an article in the April 26 issue of the New England Journal of Medicine. The $2.5bn (€1.8bn) a year drug was pulled from the market in 2004, five years after its approval, because its long-term use was eventually linked to an increased risk of heart attack and stroke. The FDA has since been making efforts to try and clear the mounting backlog of these studies and improve the situation. Last year the regulator commissioned a consultancy firm to recommend ways of boosting the completion rate of these studies and the outcome of the investigation is expected in the next few weeks. Meanwhile, the clinical trials industry has also been scrutinised of late over the issue of trial data transparency and access to information on planned, ongoing and both positive and negative results of completed trials. Along with GlaxoSmithKline (GSK), Pfizer is leading by example in trying to improve the transparency of clinical trials by listing details of their own trials on their company websites. The FDA first posted database of all the industry's post-marketing commitments on its public website in 2003.
