FDA policies may be responsible for over 80,000 deaths caused by inadequately or completely untested medical devices.
There are over 32 million Americans with implanted devices in their bodies-- about ten percent of Americans. That's mind-boggling. But more so is the fact, reported by an article in the Washington Post, The FDA is still letting doctors implant untested devices into our bodies. The ICIJ--International Consortium of Investigative Journalists--reports that "FDA data reveals more than 80,000 deaths and 1.7 million injuries possibly linked to medical devices in the past decade." And hundreds of thousands of patients with implants have had to deal with device recalls, often requiring removal of a device.
While the FDA is claiming to be planning to make "transformative" changes in their regulations, the reality is that there are huge loopholes that, for decades, have allowed manufacturers to evade real clinical trial testing. The problem is, the FDA identifies the device manufacturers as its customer base. That reflects the pathological neoliberal capitalism over a people-supporting-commons nature of politics today. The WaPo article advocates for the re-opening of the Office of Technology Assessment, which, the Post observes, "the House of Representatives killed in 1995, during a fit of anti-regulation insanity inspired by Newt Gingrich's Contract With America."
The problem is, in recent decades, presidents have appointed FDA heads who are loaded with conflicts of interest, coming from the industries they are supposed to regulate. The WaPo argues that the head of the FDA should be a civil servant, not a political appointee. Of course that takes away power from the president who appoints and the congress that authorizes. So the FDA problem is really a symptom of power-grabbing gone wild. And what legislator running for office would campaign on wanting to give away power? It's a conundrum.
The ICIJ article reports that it's even worse in other countries, where they "place their trust in U.S. and European authorities." That mirrors my experience. Twenty-five years ago I met, in Moscow, with the head of the Russian counterpart to the the USA's National Institute of Health. Shortly after, I received a call from someone at the FDA, asking me to advocate to him for adoption of the FDA's policies on drugs and devices. The FDA was actively evangelizing its policies to the rest of the world. I saw it as an extension of the marketing arm of Big Pharma and the device manufacturers.
The idea of anti-regulation and deregulation is a core value of conservatism. The policy, which is, in my mind, a core reason tens of thousands of people are dying because of inadequately tested medical devices, is a part of the malignant form of predatory, psychopathic capitalism that both political parties in the USA have allowed to become dominant.
It is certainly possible for the existence of a regulation-embracing capitalism couched in the wisdom of bio-mimicry and an understanding of how nature sustainably functions. This is a bottom-up, connection-conscious way of seeing the bigger picture, which includes the effects of products on people's health. It is insane that the FDA has failed to identify the U.S. health consumer as its customer. And it is outrageous that congress and decades of recent presidents have enabled, even encouraged, this to happen. Worse, it is clear that deregulation of protections is happening in virtually every federal agency with mandates to protect the public, workers and the environment.
Adding insult to injury, we have this added reason to be concerned. The FDA has been hit by Trump's refusal to approve government funding. This is the message the Trump administration has authorized, that's on the FDA website:
FDA Lapse in Funding
In the absence of either an FY 2019 appropriation or a Continuing Resolution for FDA, beginning on December 22, 2018 and continuing until the date of enactment of an FY 2019 appropriation or Continuing Resolution ("lapse period"), agency operations continue to the extent permitted by law, such as activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fee funds. Read more