Mesh Medical Device News Desk, May 6, 2016 ~ Conflicts amid experts and secret CVs is the focus of a Public Citizen lawsuit filed against the Food and Drug Administration over its “unlawful” redacting of panel experts CVs.
On September 8 and 9th in a large meeting room in the Holiday Inn in Gaithersburg, Maryland,
The US. Food and Drug Administration (FDA) regularly calls on 50 panels of different experts who help determine the future of medical devices and drugs. At this meeting, 18 panel members, chosen for their expertise, would try to address the many complications being reported about pelvic mesh to determine if it should be reclassified or recalled.
While the agency is not required to follow the conclusion of its experts, it usually does.
At the conclusion of two days, the members generally agreed that mesh for pelvic organ prolapse (POP), a larger polypropylene mesh, should be considered high risk or class III. It took the agency nearly five years to implement the reclassification of POP mesh, which is still underway.
Experts agreed pelvic mesh for stress urinary incontinence (SUI) would remain classified as a moderate risk and today is still referred to as the “Gold Standard.”
Anyone panel member who had a financial or personal interest with any product or industry involved was required to exclude themselves from that discussion.
For this particular panel gathering of the Obstetrics and Gynecology Devices Panel, no conflict of interest waivers were issued and no one stepped down.
Public Citizen Sues FDA
Now two attorneys at the consumer advocacy group, Public Citizen say the FDA is not revealing all it can about panel members and their potential conflict of interest with manufacturers.
In a Freedom of Information Act (FOIA) lawsuit filed April 27, Public Citizen cites numerous redactions of curriculum vitae (CVs) of panelists, something it calls “unlawful.”
Public Citizen filed the action after trying unsuccessfully to obtain the full background on the panelists. The FDA was using personnel to routinely redact portions of their resumes.
The complaint filed in the US District Court for the District of Columbia, asks the CVs be made electronically available and asks the agency to post unredacted copies of the curricula vitae of advisory committee members on its website.
“Defendants have no legal basis for refusing to produce these records in full,” says the Complaint.
Dr. Michael Carome and Rachel Clattenburg, both attorneys for Public Citizen, said confidential information is not appearing on the resumes and they want to know why.
Clattenburg tells Mesh News Desk that an agency with limited resources should not be spending time involved in questionable redacting activities.
The FDA responded to Public Citizen its practice is to categorically redact certain information from CVs including on non-government funded grants, pending clinical trials and publications, dates degrees were conferred, medical board and professional associations, names of graduate students they supervise, military service and information related to hobbies and outside activities.
The information redacted “does not fall within any FOIA exemption,” says the FDA.
Public Citizen and the public needs to make that determination with information to “assess the backgrounds and potential biases of advisory committee members,” says the Complaint.
Clattenburg, told Stat, “The redactions are unjustified and show that the FDA has wasted considerable time going through (resumes) to black out information. We worry that the FDA’s treatment of advisory committee member (resumes) is an indication that the agency favors secrecy over disclosure.”
Background on Conflicts
What you don’t see may be relevant.
In August 2008, the FDA revised its guidance for the advisory committee members on conflict of interest and eligible participation in FDA advisory committees. The guidance is not legally enforceable and relies on the word should rather than must.
In July 2014, San Francisco gynecologist, Dr. Andrew Brill was due to appear on the FDA’s panel reviewing the disturbing reports coming in about the power morcellator and its ability to spread undiagnosed aggressive uterine cancers.
See a Wall Street Journal, July 11, 2014, report here.
Dr. Brill stepped down on the eve of that July panel gathering after the FDA reviewed his conflict with Johnson & Johnson, maker of the medical device he was set to review.
Dr. Bill had reportedly received almost $213,000 from J&J’s Ethicon unit for consulting activities. Ethicon is the maker of one version of the power morcellator.
According to an FDA spokesperson talking to the WSJ, Brill had stepped down citing fees from J&J that were “just above the threshold established for panel members to participate in one of our meetings.”
The FDA streamlined its guidance regarding conflict of interest in 2008 limited the combined value any payments to $50,000. Brill had collected nearly double that.
Transvaginal mesh litigation has revealed that mesh manufacturers hire doctors as “preceptors” to teach others about the use of pelvic mesh. Additionally, “key opinion leaders,” as they are called, are brought in to innovate and promote products, to consult with industry and to speak and travel at the behest of mesh makers.
Despite the conflict that appeared in 2014, Dr Brill did appear as a nonvoting member on the Obstetrics and Gynecology Devices Panel gathered in Gaithersburg in September 2011 to determine the future of POP and SUI transvaginal mesh.
What was Redacted?
On May 19, 2014 Public Citizen filed a Freedom of Information Act request to obtain unredacted copies of curricula vitae of FDA advisory committee members and asked they be put on the FDA’s website.
Public Citizen found of 150 resumes posted on the FDA site, 138 had redactions or 92 percent. The Center for Devices and Radiological Health committee of 128 resumes 126 had redactions or more than 98 percent. The CDRH oversees medical devices such as hernia and pelvic mesh.
While a FOIA is supposed to be fulfilled in 20 working days, the Public Citizen request went unfulfilled for more than 480 working days.
Public Citizen’s advocacy has resulted in 23 FDA-regulated drugs being pulled from the market. In August 2011, it was the first organization to call for a ban on surgical pelvic mesh citing the serious, life-altering complications. #