Back in the 1970s, when I sat on the FDA Consumer Consortium, an eclectic advocacy group comprised of organizations concerned with the health and wellbeing of various constituencies, I quickly learned that the FDA approval process needed watching. That was never truer than now.
Recently, as reported by the New York Times, the Food and Drug Administration went public with the fact that it couldn’t guarantee the long-term safety and efficacy — FDA’s twin mission — of a particular medical device, vaginal mesh products, that have been on the market for decades. Women were not surprised. Many of them remembered what Thalidomide and DES had done to them or their mothers, and many had experienced the failures and problems associated with breast implants.
Despite well-documented breast implant problems, an implant linked to a rare cancer is still being sold in the U.S., even though it’s banned in many other countries, because the FDA says there isn’t enough data to justify banning them. The vaginal mesh products in question, which support pelvic organs, have long been tied to life-altering injuries, according to the Times report. Eighty deaths were reported as of last year as a result of mesh complications, and over the past decade several companies have paid out $8 billion to resolve over 100,000 patient claims. Here’s what’s really shocking: Most of these medical devices were approved with almost no clinical data to support their safety.
As the Times story noted, “When trouble arises, devise makers equivocate, regulators dither, and patients seeking redress are forced into lengthy, expensive court battles.” That means that faulty or dangerous products can be on the market for years.
Vaginal mesh products were finally removed from the market in April, but the FDA has said it will not ban the breast implant linked to cancer and other forms of “breast-implant illness” because FDA regulators claim there is insufficient evidence of harm to justify pulling the product.
It’s not only women who are affected by poor FDA oversight or sheer negligence. Metal hips, implantable defibrillators, and artificial heart valves have also proven disastrous in some instances. “There have also been staples that misfired, temperature control machines that spray bacteria into open chest cavities, and robotic surgeons that slap, burn and main patients,” according to the Times story.
In every one of these cases, dubious regulatory approvals, poor post-market surveillance, and inadequate responses from regulators have caused irreversible, and avoidable, harm.
According to the International Consortium of Investigative Journalists, nearly two million injuries and over 80,000 deaths have been linked to faulty medical devices, many approved with little or no clinical testing. The FDA has continued to promised “transformative” changes to medical device regulation, but it’s ideas for improved regulation have yet to be realized, while regulation of the device approval process has generally accelerated. The head of the FDA office responsible for device regulation, Dr. Jeffrey Shuren, a former venture capitalist, is fine with that. He’s on record saying the benefits of getting innovative products to the marketplace quickly is worth the increased risks.
The FDA’s history hardly encourages hope that its regulation and oversight will improve any time soon. Its numerous scandals include a 2016 insider trading prosecution and a 2009 politicized medical device approval. A 2013 ProPublica investigation found the agency had overlooked fraudulent research and allowed potentially unsafe drugs to remain on the market.
How can such corruption be explained? First, follow the money. According to a 2018 report in Science Magazine, 40 physician advisors out of 107 who voted on FDA committees received more than $10,000 in post hoc earnings or research support from drug manufacturers whose products were approved by panels on which the physicians served. Almost half of the 40 physicians who were rewarded for their vote got more than $100,000, and six received more than $1 million.
As a blogger on http://globalnaticorruptionblog.com noted in 2017, “Corruption blooms where transparency and accountability are lacking.”
Because of that, “Instead of a regulator and a regulated industry, we now have a partnership,” Dr. Michael Carome, director of the health research group at Public Citizen, told ProPublica last year. “That relationship has tilted the FDA away from a public health perspective to an industry friendly perspective.”
So what can be done about a growing list of FDA disasters? Most advocates agree approval standards must be tightened so that loopholes can be closed, most importantly those that allow medical devices to hit the market in the absence of human testing. Post-market surveillance also needs to be fixed. It’s unbelievable that medical devices can be on the market before enough rigorous testing has occurred by manufacturers who argue that further testing of products occurs once they are being used. Finally, the revolving door that allows manufacturers and Big Pharma folks, who fund much of FDA’s mission, to work for the industry, then for the FDA, and back with industry again must be disallowed.
No patient should have to worry about medical devices, procedures or drugs being dangerously flawed or life-threatening. For those who have died when they are, the least the FDA can do is to correct course on their behalf, quickly and completely.