Consumers, Conflict of Interest, and the FDA
Guest Contributor Kim Witczak, WoodyMatters.com
Most people have no idea how political the FDA drug approval system can be. I know I didn't before my husband's unexpected death over 13 years ago from an undisclosed drug side effect of antidepressants. Since then, I have been working on FDA and other pharmaceutical drug safety related issues.
Earlier this year I was appointed to serve as Consumer Representative on the FDA Psychopharmacologic Drugs Advisory Committee. This is an honor and something that I do not take lightly as there are real life consequences to the topics being discussed at these advisory meetings.
Last month, the FDA convened a special joint meeting with the Psychopharmacologic Drugs Advisory Committee and Drug Safety Risk Management Advisory Committees to consider Pfizer's request to remove the black box warning from the smoking cessation drug, Chantix. There have been numerous warnings on Chantix starting in 2008, a year after it had come to market. The current black box warning includes a link to serious neuropsychiatric symptoms including depression, violence/aggression, psychosis, and suicidal thoughts. This was the second time Pfizer has tried to get the boxed warning removed. On October 16, 2014 they were unsuccessful and the 2014 Advisory Committee voted to keep the black box warning on the drug and wait for the results of a large safety study that was underway.
Unfortunately, I was NOT allowed to serve at this particular advisory meeting on Chantix. Five days before I was supposed to fly out to Washington, DC, I received an email from the FDA stating that I was disqualified from participating due to CR 502 - Federal Conflicts of Interest ruling. They determined me to have a bias because of a lawsuit against Pfizer for an unrelated drug that resolved over 10 1/2 years ago. I was the only member recused from participating on the committee.
Much to the FDA and Pfizer's surprise, I still flew out to Washington, DC on my own dime to speak for 3 1/2 minutes during the open public comments portion of the meeting. After all, I had devoted enormous amount of time reviewing the briefing materials in preparation for this meeting and wanted to make sure my voice was heard. It was too big of a potential safety issue for consumers and their physicians not to show up.
Well, unfortunately the meeting didn't go as I had hoped. Despite numerous issues with the Pfizer-sponsored large safety study, the advisory committee voted to REMOVE the black box warning. This is an UNPRECEDENTED move as very few black box warnings have ever been removed. Time will tell if the FDA will actually follow the recommendation of the advisory committee. Regardless, this is new territory for drug safety and will impact ALL of us.
This experience raised two major concerns for me:
1) The larger impact of drug companies being able to get black box warnings reversed. What will be the unintended consequence to the public? Will people believe the drug is now safe? How will Pfizer and the media, intentionally spin this? Neither the FDA nor the Advisory Committee heard from the 2,700+ victims who were silenced by Pfizer in their settlements by lawsuits brought on before these black box warnings were added. Were the 17,000+ real world serious adverse events reported to the FDA through its Medwatch system even considered? Or the Citizen Petition filed by Consumer Reports, Public Citizen, the National Physicians Alliance, and the National Center for Health Research? In my mind, ALL data must be carefully considered and weighed when a black box warning is removed.
2) The influence of industry on the FDA advisory committees. Intellectual or appearance bias is a relatively new form of conflict of interest that FDA uses selectively. Who is deciding who has an intellectual bias? Again, it wasn't until Pfizer brought my lawsuit from over 10 years ago to the attention of the FDA. The FDA was already aware of my previous statements on Chantix in 2014 and said it wasn't an issue.
This is not the first time the "intellectual bias" has been used to have an advisory committee member removed from the committee. In 2011, the FDA tried to remove Public Citizen's Sid Wolfe from serving as the Consumer Representative member of the FDA's Drug Safety and Risk Management Advisory Committee reviewing the controversial birth control YAZ. The FDA's rationale for removing him was due to Public Citizen's recommendation in one of their newsletters warning of the drug being considered by the committee. Eventually after much discussion, Sid was allowed to participate in the deliberations of the meeting, however, was NOT allowed to vote.
Advisory members possessing information and views on matters being discussed is not a conflict of interest. Most experts including consumer and patient representatives are likely to have developed views on a variety of subjects based on their professional experience, including their own research and review of the scientific data. The fact that they have information and reached conclusions should not be a disqualifying factor.
Excluding advisory committee members because they have differing views on scientific matters threatens the very role of FDA advisory committees. First, it robs the FDA of advice from the very experts most qualified to give it - those who have actual knowledge and research experience concerning the subject being discussed by the advisory committee. Second, it may discourage qualified people from participating out of concern that their expertise may become controversial. And lastly, it encourages politicization as those with vested interests may try to exclude consumer, patient, and scientist experts whose views are inconvenient to them.
If intellectual conflict of interest means being informed and subsequently having opinions on a drug, many more members of FDA advisory committees, even without a financial conflict of interest, would have to be excluded because they know too much. At the end of the day, we all lose as a result of this.
I will continue to represent the real world voice and perspective on the national level. However, I have come to realize that the real change is not going to happen within the system. It's going to come from you and I waking up and saying enough.