Mesh Medical Device News Desk, November 6, 2018 ~ Expert Panels often decide to approve drugs and devices, but how objective are the panelists and do conflicts make a difference?
A report in Science Magazine (here) has peeled back to revelations of the conflict of interests that exist among experts who advise the U.S. Food and Drug Administration (FDA).
The FDA convenes Advisory Committees made up of outside experts with experience in a particular field. Occasionally there is even a patient representative among the panel. Together they look at drug and device reviews, clinical trial data, safety and efficacy issues. They then vote on whether to recommend the drug/device approval.
The FDA generally follows the recommendation of its committee members.
Part of being a panelist means that conflicts of interest must be revealed. Does the medical expert have any research support, consulting contracts or any other payments from a drug or device company? What is not covered is if the committee member may received a financial incentive either after the drug/device is approved or after they are named to the panel, according to the Science investigation.
Using disclosures in Centers for Medicare & Medicaid Services from 2013 to 2016 posted in Open Payments Website, Science found 40 of 107 physician advisers received more than $10,000 in earnings or research support from the very companies whose drugs they voted to approve. Twenty-six received more than $100,000. Seven received more than $1 million. The FDA never disclosed many of the top committee members received funding from drug companies in years prior to serving.
The top 17 earning advisers received support either in personal payments or research funding paid by the drug companies amounting to $26 million.
Compare this to the European Medicine Agency. It prohibits the appointment of advisory committee members who have had any financial relationship with pharmaceutical companies three years prior to being on a panel.
Follow the Money generally rings true. Scientists on the panel have a lot to gain from being on a panel. One hematologist-oncologist, Dr. Vinay Prasad, tells Science. “It’s in their best interest to play nice with these companies.”
Studies looking at conflicted relationships between drug makers and the doctors who prescribe those drugs found doctors who are paid by the pharmaceutical companies are more likely to prescribe those drugs. See University of North Carolina, Yale University, the George Washington University and Harvard Medical School.
Carl Elliott, a medical ethicist at the University of Minnesota says, “Even in the best of circumstances, disclosure is a remarkably weak way of controlling conflicts of interest. A better way would simply be for the FDA to say, ‘We are not taking anybody with any kind of conflict on an advisory committee,’.”
On transvaginal mesh – The FDA convened an expert panel in September 2011 (here), after many complications reports were coming in concerning the use of surgical meshes in women to treat SUI (stress urinary incontinence) and POP (Pelvic organ prolapse).
It concluded POP mesh was a problem but slings were not.
It took until 2016 for the FDA to reclassify POP mesh as high risk or Class III and even then, the agency gave manufacturers the benefit by allowing 30 months for the devices to remain on the shelves and presumably used. Mesh News Desk has learned at least two panelists had conflicted relationships with industry.
Whether you think a financial conflict with a drug/device maker makes a difference to your care, you can research these relationships.
The Physician Payments Sunshine Act of 2010 requires manufacturers of drugs/devices to report payments to doctors and teaching hospitals. You can check that out on Open Payments and look up your doc on the Search Tools.
For example, Dr Andrew Brill, who was on the pelvic mesh panel, was scheduled to be on the 2014 Morcellator Advisory Panel but stepped down due to a conflict of interest with Johnson & Johnson. The San Francisco gynecologist received nearly $100,000 in consulting fees in 2013. The general cutoff that defines a conflict of interest is $50,000 under FDA guidelines.
Other panelists on the morcellator panel were also found to have conflicts, though not as large as Dr. Brill.
ProPublica, Investigative Journalism in the public interest, also has a database of payments to physicians. Dollars for Docs is user-friendly, easy to read and is based on data required under the Physician Payment Sunshine Act.
For example, look up Pelvic Organ Prolapse (here) and see the top docs who received money from Boston Scientific in 2016 – $3.4 million with Dr. Dennis Miller the top recipient at $1.16 million.
Boston Scientific, for example, made payments totaling $3.48 million to ten doctors and 10 teaching hospitals related to pelvic organ prolapse here.
Doctors on the receiving end include Dennis Miller from Milwaukee, WI, Roger Goldberg of Evanston, Illinois, Peter Rosenblatt of Cambridge MA. not only for vaginal mesh but for testing of other things like a Premarin cream drug and a sacral nerve stimulation device, consulting and licensing fees for devices co developed with the company.
Florida Hospital was the top recipient at $262 million.
Dr. Miller has a long history with Boston Science.
He claims to have helped Boston Scientific invent the Pinnacle Pelvic Mesh kit. See the background story here.
Miller says he brought the idea of using the Polyform mesh (a sheet of Marlex) and combing it with the Capio, a small hooked device with better access deep into the pelvis to more effectively affix the prolapsing organs. Using the Capio, one could avoid passing trocars or long needles through the pelvic space in a blind procedure.
Dr. Miller’s payments shown total more than $206- thousand from Boston Scientific as recently as December of last year here .
Overall, he has made nearly $6 million in royalty and licensing fees from Boston Scientific. See federal data here.
Pinnacle, a pelvic mesh used to shore up a pelvic floor and organs, was found to be defective in this country and was recalled here. However, label changes to Boston Scientific pelvic mesh devices (here) shows it is still being used overseas by Boston Scientific International.
As recently as February 2018, Germany’s research institute BfArM, sent out an Urgent Field Safety Notice on the Pinnacle Anterior Pelvic Floor Repair Kit and Pinnacle LITE Posterior with Capio device.
While choosing a doctor is an important step in your health care, you may want to know how objective his or her attitude is toward drugs and devices. ###
MND, Doctor Sunshine- What You May Want to Know About Your Doctor’s Conflicts of Interest July 4, 2016 (here)
MND, FDA: Expert Panelist on Morcellators Out Due to Conflict of Interest, July 31, 2014 (here)
Science Magazine, Hidden conflicts? Pharma payments to FDA advisers after drug approvals spark ethical concerns, July 5, 2018 (here)
2011 FDA Meeting Materials Obstetrics and Gynecology Devices Panel (here)
ProPublica’s – Dollars for Docs