FDA Advisory Panel's Anti-Bias Policy Creates Bias: Is "Fahrenheit 451" Todays Reality?

Recently, the National Academies of Sciences, Engineering, and Medicine removed two very respected scholars, Mary Lynn McPherson, PharmD, and Gregory Terman, MD, PhDalong with other doctorsfrom the FDA medical advisory panel. The National Academies of Sciences, Engineering, and Medicine will not officially disclose their reasons for removing Dr. McPherson and the other highly qualified doctors from the panel. However, Sen. Ron Wyden (D-Ore.) likely was involved. The ousting apparently was motivated by a letter that he sent to the panel. In it, the senator pointed out that Dr. McPherson received grants and funding for medical residents worth at least $300,000.

According to a Baltimore Sun article, Dr. McPherson, who teaches at the University of Maryland School of Pharmacy, and specializes in hospice and end-of-life care, received funds from Purdue Pharma in Dr. McPhersons name to provide students with education and training. Supposedly, that created a conflict of interest. However, it is common practice for industry to give unrestricted, specified grants to universities and professional societies for research and to promote education.

Furthermore, Dr. McPherson did not personally receive any of the funds, according to Natalie D. Eddington, PhD, dean of the University of Maryland School of Pharmacy. In the Baltimore Sun article, Dr. Eddington says, Her expertise as a world-renowned educator and practitioner would have been invaluable in formulating new strategies for dealing with the opioid addiction crisis facing the United States.

Apparently, Dr. Terman was removed from the panel because he is president of the American Pain Society. The American Pain Societynot Dr. Terman personallyhas received funds from industry.

According to the National Academies website , some funding for the organization itself comes from industry. Apparently, there is a double standard employed when evaluating its own organization and those who participate on an FDA advisory panel.

Association Doesnt Necessarily Mean Bias

In my opinion, removing Drs. McPherson and Terman from an FDA advisory panel is unhelpful. It is part of an ongoing effort to, in effect, punish and silence anyone who is associated with an opioid pharmaceutical company. Some people assume that such associations must create bias and cause conflicts of interest. Certainly, such associations do not create any more bias than does the act of intentionally dampening the voices of different perspectives and rejecting the contributions of esteemed researchers.

The National Academies removal of dedicated physicians and researchers from an FDA medical advisory panel limits freedom of professional expression. If this were an isolated incident, that would be worrying enough. But it appears to be part of a trend.

Many individuals (or organizations) who advocate for people in pain are being discredited or silenced. This is causing incalculable harm to people in pain, and the implications are very disturbing.

There is real danger associated with Sen. Wydens attempt to purge members who have any connection with industry. Its more than a serious threat to our patients. It is even threatening the democratic process because it limits participation (and the ability to provide input) in a regulatory group to those people who think in a certain way.

Eliminating people who have any association with pharma is, in essence, stacking the deck. It creates a special interest group thats empowered to influence policy. The unfortunate irony is that this attempt to limit bias actually is creating bias.