NEW BRUNSWICK, NJ—Disclosures on the website of Johnson & Johnson’s (J&J) Ethicon subsidiary reveal that Dr. Andrew I. Brill, a San Francisco gynecologist specializing in minimally invasive gynecologic surgery, and his company AIB Consulting, received a total of $155,000 in payments from the global big-pharma giant since 2010.
As we reported, Ethicon is the largest manufacturer of a controversial tool used to perform uterine surgery known as a laparoscopic power morcellator.
News broke last month that Brill had removed himself, at the last minute, from the 16-member expert Food and Drug Administration (FDA) safety panel before two days of hearings on morcellators were scheduled to begin.
"During the course of the agency's review and in consultation with Dr. Andrew Brill, it was determined that the financial information he disclosed was just above the threshold established for panel members to participate in one of our meetings," an FDA spokeswoman told the Wall Street Journal's Jennifer Levitz.
Brill was considered a "special government employee" subject to the Ethics in Government Act. The spokesperson said the "threshold" in question was whether or not an employee (or their immediate family member) received in excess of $50,000.
In April, the FDA recommended that doctors stop using power morcellators during uterine surgery because it concluded that the risk of spreading cancer was higher -- 1 in 350, rather than 1 in 10,000 to 1 in 500, as previously thought.
The procedure that the FDA warned doctors to stop using was performed on tens of thousands of American women each year until J&J announced that it would suspend sales and marketing of its morcellators by the end of April. J&J did not recall the devices until the beginning of August.
What is Brill’s connection to J&J? The company told Levitz that “Dr. Brill has done professional education consulting in the firm's women's health and energy businesses and that he is a recognized leader in the field.”
In September 2011, Brill was a member of another advisory panel where the outcome of the review held great importance to J&J.
That year he was a non-voting member of the FDA Medical Devices Advisory Committee/Obstetrics and Gynecology Medical Devices Panel reviewing another J&J product. That product, a pelvic mesh implant, has ultimately resulted in tens of thousands of lawsuits against J&J.
Brill, or his consulting company, have collected consulting fees every year since 2010, according to J&J’s Ethicon website, but the figures listed for 2010 are incomplete.
“Payment reporting began in 4th Quarter 2010. The 2010 report only reflects payments made in 4th Quarter 2010,” states the J&J website.
In 2011 Brill's company, AIB Consulting, received nearly $37,500 according to J&J’s website, on top of $13,000 in the final quarter of 2010.
In 2012, AIB Consulting received just $11,000, but the payments ballooned to a total of $93,500 in 2013, bypassing the company and going directly to Brill himself.
It is not yet clear whether Brill or his company has received any payments this year.
"I'm afraid the FDA relies too heavily on industry to take its marching orders," said Jane Akre, a journalist who has been organizing survivors of pelvic mesh implants for more than five years.
"We know for a fact that industry has private sit down consultations with the FDA concerning upcoming expert panels. That is what happened in advance of the pelvic mesh panel," Akre told New Brunswick Today.
“We do not know what if anything Dr. Brill had taken by 2011 where he attended a September expert panel convened by the FDA on pelvic mesh. By 2014 it was enough to have him excluded from a morcellator panel.”
J&J was not required to disclose payments to physicians or consultants until the Physician Payment Sunshine Act, which requires all manufacturers of drugs, devices, and biological and medical supplies covered by federal health care programs to disclose all financial relationships with physicians and teaching hospitals.
That law was signed by President Barack Obama on March 23, 2010, and enacted along with the Affordable Care Act (ACA).
A new Centers for Medicare and Medicaid Services (CMS) website is expected to launched later this year to provide the public with greater transparency.
The law requires most drug and device companies to report detailed information to CMS about payments and gifts given to U.S. doctors.
The website will list all payments to physicians from drug and medical device companies via an open payments verification system as required by the Sunshine Act provision of the ACA.