Does Pharma 'Highjack' FDA Public Comment on Cancer Drugs?

ksusan · February 2016

Requires a free Medscape membership.

About one-third of "public" speakers at US Food and Drug Administration (FDA) advisory committee meetings on yet-to-be-approved cancer drugs in recent years had financial ties to the pharmaceutical industry, according to new research.

In other words, public testimony, which is mostly from patients and the staff of nonprofits, and can be emotionally compelling, is regularly supported by private interests.

"The industry has hijacked that microphone; they're using it as their second presentation at advisory committee meetings," senior study author Vinay Prasad, MD, MPH, from the Oregon Health Sciences University in Portland, said in a press statement about the findings, which were published online February 1 as a research letter in JAMA Internal Medicine....

Public comment at ODAC was overwhelmingly in favor of the drugs under discussion, the study indicates: 95 of the 103 (92%) speakers supported marketing approval; only six (5.8%) speakers did not (two were neutral).

This occurred even though ODAC meetings are typically reserved for drugs "where the risk–benefit [ratio] is even more questionable than usual," Dr Prasad explained.

Notably, 31 (30%) of the public speakers reported financial ties to the drug maker, including financial support for travel to the FDA meeting or broader organizational support.

Fallleaves · February 2016

I'm only surprised the number is so low. It totally seems like the game is rigged.

Jackbirdie · February 2016

very sad, but not surprised. The FDA. Corruptible and corrupt. IMO.

BarredOwl · February 2016

Thanks for posting the link and partial content of the MedScape article. Those interested may wish to read the MedScape article in its entirety. I found this bit interesting:

"Thomas Stossel, MD, from Harvard Medical School in Boston . . . asserted that public comment is not hoodwinking the FDA.

The public testimony, in contrast, is overt advocacy, and the FDA knows it," Dr. Stossel told Medscape Medical News."

If I understand it correctly, published transcripts of the ODAC meetings were examined to determine if the speakers disclosed whether they have ties to, and/or financial support from, "organizations relevant to the drug or the cancer" type (the latter is broad). How often was there a failure to disclose such information (in whole or in part)? The authors report:

"Two individuals disclosed organizational affiliations but not financial associations, and subsequent searches of online information showed that the specified organizations received financial support from the sponsor before the meeting."

For all I know, this could have been an innocent error on the part of two speakers, who may have been unaware of third party support provided to the organization (with whom they did disclose a relationship). From this examination of published transcripts of the meetings, it appears that the ODAC committee members are made aware of such ties in the large majority of cases examined. They are scientists by training and they understand the concept of bias.

Here is a link to the first page of the original report, which is worth a read:

http://archinte.jamanetwork.com/article.aspx?artic...

Here is a link to an accompanying editor's note, indicating the scope of the problem observed appears to be small, but that improvements in the process would be beneficial:

http://archinte.jamanetwork.com/article.aspx?artic...

BarredOwl

leggo · February 2016

All whilst sporting their "complimentary" Rolex watches.

cp418 · February 2016

http://www.prnewswire.com/news-releases/breast-can...

Breast Cancer Market in APAC Region Hit $1.9 Billion in 2014 and Will Reach $3.4 Billion by 2021, says GBI Research

Does Pharma 'Highjack' FDA Public Comment on Cancer Drugs?

Comments

Breast Cancer Market in APAC Region Hit $1.9 Billion in 2014 and Will Reach $3.4 Billion by 2021, says GBI Research

Categories