A modern-day wolf in sheep’s clothing: FDA’s Center for Devices and Radiological Health (CDRH)

by Hooman Noorchashm, MD, PhD

Published Feb. 4, 2015, 10:13 a.m. ET

The Food and Drug Administration's (FDA) stated mission as a federal agency in the United States is: "protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation."

Since its founding, like many American institutions, FDA has earned a place of prominence and leadership among the governments of the world. An FDA approved product is hailed, world-wide, as safe, effective and life-saving. For the food, drug and medical device industries, an FDA brand of approval is a guaranteed ticket to effective marketing and good profits.

So, the FDA's mission is critical to public health and safety. Specifically because the industries it regulates market products that come in direct interface with the people's physical lives and health. Harmful or faulty products stand a very good chance of harming or killing unsuspecting consumers and patients. Therefore, unlike any other federal agency, the FDA's mission, ethics and actions must be closely monitored by the press and the public and its representatives – far more so than it currently is.

In recent years, the FDA's mission has been severely compromised and its actions masked from the public eye. Nowhere is this corruption in purpose more evident than in the FDA's Center for Devices and Radiological Health (CDRH). The CDRH is the center within the agency that is responsible for authorizing medical devices for marketing and use in patients in the United States.

The very serious problem at the CDRH is that its leadership is primarily committed to the concept of getting "life-saving" devices to market "efficiently" – That is, boosting the medical device industry's capacity to market and sell its presumably "life-saving" products to the American healthcare system and to trusting patients.

Patient Safety is, at best, a side-note for the CDRH. Our history has demonstrated that when safety becomes a side-note for industry, people's lives are destroyed and many die unacceptable deaths.

Of course, the CDRH leadership would verbally dispute this accusation and attempt a rhetorical defense. But functionally, when one studies the inner workings of this center and its leadership at the FDA, a basic truth is immediately apparent: The CDRH authorizes a wide majority of medical devices in the United States without any safety testing requirement and without any robust mechanism for surveillance of adverse outcomes. These are verifiable facts.

So when a FDA authorized device enters the healthcare marketplace in the United States, the American consumer and patient has no assurance of safety or even efficacy. This is a severe public health and safety failure in our federal government, caused by our own public health agency. And as a result many American lives have been compromised and many have died unnecessarily and avoidably. The specific legal mechanism used by the CDRH to clear medical devices for marketing is known as the 510(k) amendment. It is the dominant legal tool used by CDRH, and supported by its leadership, to unleash medical devices into the American market place.

One wonders why the FDA leadership and congress have allowed such a disturbing and far-reaching breach in its mission to take hold. The answer is, unfortunately, a systemic one. Our government agencies and congressional leadership, including the FDA and the United States senate's Health, Education, Labor and Pensions Committee (HELP), are now dominantly infiltrated by industry advocates and lobbyists, whose corporate interests over-ride the very voice that the United States Federal government was originally designed to protect – the people. The main purpose of our federal government now seems to be stimulating industry, boosting the economy and "innovating". The protection of the lives, rights and property of the individual American citizens in harms way appears no longer the purpose – or at best is invoked as a political campaign slogan or marketing cliche.

It therefore stands as a self-evident truth today that the FDA, whose mission is to shepherd and protect the public's health in the United States, is no longer true its original dictum. The FDA, and particularly its CDRH, is now primarily committed to "efficiently introducing 'life-saving' devices to the healthcare marketplace". And, this new mission is not a public health mission, it is an industry health and marketing mission.

I thought that a widely recognized verse from the Gospel fits what is happening to our nation and its federal agencies quite appropriately: "Beware of false prophets, which come to you in sheep's clothing, but inwardly they are ravening wolves".

When a federal public health agency's leadership and our congressional leaders are more committed to efficient marketing and economics than to people's very lives and safety, we are in trouble. Because "wolves in sheep's clothing" are charged with protecting a republic created "for the people, of the people and by the people". Not for industry, of industry and by industry. The free-market and industry entrepreneurship must be preserved in America, but our federal government was created to foremost protect the individual American's life, rights and property – not corporations' and industry's.

I ask you, the reader, who must preserve and protect the public's well-being in America? And how?

Public health and the robustness of our healthcare insurance infrastructure rest at the core of our republic's survival. On the issue of public health, the individual American citizen, you the reader, cannot sit silent, trusting and complacent and permit industry and its advocates to highjack our congress and federal agencies.

The FDA's Center for Devices and Radiological Health has been exposed as a "wolf in sheep's clothing". I ask, "Where is the voice of the American people standing in defense of the lives threatened? Where are the shepherds in American federal government?"

Hooman Noorchashm has campaigned to ban electric morcellators since December 2013, soon after his wife's unsuspected uterine cancer was spread by the device during a routine hysterectomy.