FDA's advisers on opioids booted for ties to industry, AP learns

fda

Having been buffeted by controversy over its approval of addictive opioid drugs, the FDA is calling on a panel of experts to help it sort through the thorny issue. But even before the new panel met, it has been tinged by controversy itself, dismissing four advisers because of perceived ties to drugmakers.

The panel, selected by the National Academies of Sciences, Engineering and Medicine, held its first meeting this week in Washington, DC. But one day prior, the panel let some advisers know their nominations had been withdrawn, the Associated Press reports. A spokesperson for the academy confirmed to the news service that four advisers were eliminated from the panel but wouldn’t say why. At least two of the four had been called out by Sen. Ron Wyden (D-OR), a vocal critic of pharma’s influence over panels that make recommendations.

One of those is Dr. Gregory Terman, a board member for the American Pain Society, which the AP says has received at least $132,000 in contributions over 18 years from drugmakers that sell painkillers, including Purdue Pharma, Pfizer and Teva.

Infographic

[Infographic] Machine Learning, Statistics and Optimizing Outcomes

In our infographic, we outline the potential of fusing machine learning and statistics algorithms together to more efficiently analyze clinical trial data output and ultimately revolutionize clinical research.

The other was Mary Lynn McPherson, currently a professor at the University of Maryland School of Pharmacy, who does work in hospice and end-of-life care. She has been the recipient of residencies and grants for which the industry has contributed at least $300,000, the news service said.

Terman told the AP he learned the day before that he would not be included on the panel. “I responded that I’m very proud of my relationship with the American Pain Society,” Terman said. “We’re the only professional society in the world that thinks of pain science as priority No. 1.”

As for McPherson, a university spokesperson said that any implication that her work had been influenced by the industry was “deeply misguided.”

The FDA for several years has been in the midst of the national controversy for having approved new addictive painkillers even as opioid abuse and overdose deaths have reached what have been referred to as epidemic numbers.

New FDA Director Robert Califf earlier this year outlined an 8-point plan for the FDA that he said would "focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief." One of his pledges was to turn to outside experts for guidance on how to balance those needs.  

Other federal agencies also are wrestling with the issue. The Centers for Disease Control and Prevention (CDC) this year released voluntary guidelines aimed at primary care physicians, physician assistants and nurse practitioners who write the majority of opioid prescriptions. They recommend that for short-term pain, clinicians first try alternatives such as nonsteroidal anti-inflammatory drugs and if they prescribe opioids, to start with the minimum dose for just three days. The guidelines don't apply for patients getting pain drugs for cancer or who are receiving end-of-life care.

The National Institutes of Health also is looking to outside experts for advice. Sen. Wyden last week asked the NIH director for info on how its experts are vetted, the AP said.

- read the AP story

Related Articles: 
FDA's Califf calls for 'sweeping re-examination' of policies in effort to fight opioid abuse 
CDC guidelines call for drastic cuts in opioid painkiller use

Read more on

Suggested Articles

Think you’re busy? Take a look at Pfizer’s commercial team for oncology, which is currently juggling eight launches. And that’s just in the U.S.

Opioid lawsuits from cities, counties and states have left legal experts confused about next steps, and a "negotiating class" proposal isn't…

For years, Roche’s blockbuster oncology troika dominated sales stateside and abroad. For Herceptin and Avastin, those landmark years could be over.