FDA drug safety decision may have been influenced by big pharma

The Project on Government Oversight (POGO) reports that big pharmaceutical companies may be having an undue influence over the Federal Drug Administration (FDA), raising doubts over the agency's drug safety determinations.

On December 8, 2011, an FDA panel of medical experts held a vote on the relative safety of two best-selling contraceptive pills manufactured by Bayer. Asked whether a panelist's ties to Bayer had "affected her judgment in any way regarding her vote," a spokesman replied "no comment."

Two other panelists had prior ties to Bayer but claimed that their vote was unbiased.

Under consideration were two contraceptives named Yaz and Yasmin containing the synthetic hormone drospirenone. The panel concluded that the risks of taking the contraceptives did not outweigh their benefits in a 15 to 11 vote.

The FDA panel did not take into account, however, an internal Bayer document revealed in litigation against the company showing that one of the contraceptives had a rate of serious "adverse events" that was "10 fold higher than other contraceptives."

Overall, POGO found that four out of twenty-six voting panelists had prior relationships with Bayer or a generic company that markets a generic equivalent of the Bayer contraceptives. All four voted in favor of Bayer contraceptives.

The four panelists disclosed their links but the FDA did not object to their participation on the panel. Based on the panel's deliberations, POGO concluded that there was "no indication that fellow panelists were ever aware of these links as the group spent hours deciding how to deal with the well-documented risks associated with Yaz, Yasmin, and related drugs."

Legal, social, and ethical issues raised by whole genome sequencing

Using whole genome sequencing (WGS), scientists are able to describe an individual's entire genome on a molecular level.  In 1-4 years, it is expected that WGS will cost as little as $1,000, an impressive advancement given that it cost $100 million to complete the sequencing of the first human genome in 2000.

In last fall's briefing of the ABA Biotechnology Law Committee, Gary Merchant and Rachel Lindor of the Sandra Day O'Connor College of Law, discuss the legal, social, and ethical issues that WGS implicates.

The authors believe that WGS will soon bring about a genomic revolution that will have a significant impact on how we treat human disease.

The issues they identify are the following:

- whether the patents currently covering 4000 human genes will impede WGS (for an argument that this is unlikely, see this post);
- the difficulty of obtaining informed consent from research participants because of the complexity of genetic information and the potential scope of findings;
- whether findings incidental to the original purpose of a WGS should be revealed to the patient;
- how to maintain the confidentiality of the genetic information revealed and protect the patient's privacy;
- whether WGS should be conducted in non-CLIA certified labs;
- whether the FDA should pass regulations permitting only physicians to request WGS;
- liability issues in product liability and toxic tort cases and in cases against physicians;
- social and ethical issues related to predicting an individual's predispositions and predilections.