Pfizer’s Prempro Brings Attention to Pharmaceutical Reporting Issue

Pfizer, Inc. is under fire for a hormone-replacement drug produced by Wyerth, a company which it acquired earlier this year for $68 billion.

According to Daily Finance, a jury awarded a Philadelphia woman $3.75 million in compensatory damages and an undisclosed sum of punitive damages, finding a link between Pempro, a hormone drug taken for menopause treatment, and her breast cancer. The jury also found that Wyeth hid evidence of Pempro’s potential cancer risk. The woman took Pempro for five years before being diagnosed with breast cancer in 2002. Daily Finance stated that there are 9,000 more lawsuits pending across the U.S., with about 1,500 in Philadelphia alone.


Stories such as this raises concerns for South Floridians and other consumers around the country. Can we trust that pharmaceutical companies will do business responsibly and ethically with the care and safety of its customers in mind without negligently putting a defective and potentially harmful product on the market? Booster Shots, from the Los Angeles Times’ Health Section, reported on French researches who conducted a study on 133 clinical trials which were published throughout 2006 in major medical journals. Besides finding that 55 percent of the studies were funded by for-profit companies, about 11% of the studies did not report on the adverse effects of their trials.

The researchers also found that some of the reporting was distorted. For example, 36 of the studies did not distinguish between severe and mild side effects. Sixteen studies only included the most severe side effects, while 17 reported only common side effects and another 63 did not report on withdrawals of volunteers from the studies. So while the Consolidated Standards of Reporting Trials was amended back in 2001 to emphasize the importance of reporting all adverse effects and events, the French researchers concluded that from their study, more needs to be done to rectify these inadequesies. Booster Shots noted an editorial accompanying the study by Dr. John Ioannidis of the University of Ioannina School of Medicine in Greece, who saw the under-reporting by the companies as their intent on “silencing the evidence” of the potential harm.

Another concern is the fact that so many of us rely on medicine provided by these companies. Pfizer is the world’s largest research-based pharmaceutical company, according to its website. It was recently tangled in controversy, ordered to pay a $2.3 billion fine for illegally marketing the painkiller Bextera, which is no longer on the market. Furthermore, Daily Finance said that over 6 million women have taken hormone-replacement drugs to treat menopause symptoms.

We hope that more studies similar to that of the French researchers are conducted, in an unbiased and fair manner, to make the public and the medical community aware of issues such as inadequacies in reporting, so that pharmaceutical companies are reminded of their ultimate responsibility to their consumers.