A tax cut in exchange for patient safety

Recently, a few distinguished United States Senators who vocally supported the Affordable Care Act, as a measure of their party loyalty and political courage, seem to be compromising. They are supporting the repeal of the 2.3 percent Medical Device Tax, which helps fund the ACA. The cost of such a compromise to the ACA could be close to $30 billion in a decade.

by Hooman Noorchashm, MD, PhD, and Amy J. Reed, MD, PhD

Published Jan. 13, 2015, 3:37 p.m. ET

Compromise is an important component of working within a complex political landscape that is constantly changing.

This proposed medical device tax repeal is one heck of a compromise. What makes this compromise a window into the political souls of those supporting it, is that it's coming from United States Senators whose states have major economic interests tied to medical device manufacturers – MA, PA, MN, MI, etc.

This proposed compromise should trouble all citizens concerned about the well being of patients in America. Specifically because it rewards an industry that already has the economic benefit of having almost no effective federal patient safety mandates regulating it - and, as a result, has demonstrably harmed many patients.

Let us explain. The majority of medical devices in the United States are cleared for marketing by a legislative amendment to the 1976 Food, Drug and Cosmetics Act, known as 510(k). What was originally intended to be a loophole for pre-existing devices to remain in the marketplace has become the dominant mechanism for medical device approval in the United States. Since devices approved through the 510(k) legislation do not require any safety testing, this means the majority of 'new' devices coming onto the market have not been demonstrated to be safe for use in patients. To make matters worse, 510(k) doesn't even give the Food and Drug Administration a mechanism for surveillance of such devices, in case a device causes horrific outcomes in unsuspecting patients.

So, 510(k) is a great deal for industry: no extra development costs for safety testing, no inconveniences of outcome surveillance by the feds, and a convincing FDA clearance label that gives patients and doctors the illusion that they are safe and good to go. Even better would be a 2.3 percent tax cut supported by no other than the politicians who are self-proclaimed champions for those in harm's way. Everyone wins. Right? Wrong.

The losers in this are the ones left out of the above equations: the patients. The patients are the ones who become, unknowingly, the experimental subjects of medical devices cleared via 510(k). They are the ones left in harm's way, by the FDA, by the medical device industry, and by their congressional representative, without any real recourse.

Leaving an industry with little to no safety standards or federal patient safety accountability is abominable. But giving the device industry an added tax cut to boot? This truly would be an irresponsible act of governance. Coming from congressional representatives who claim to be protecting the lives and rights of minority subsets of people in harms way from corporate irresponsibility - now that might be called hypocrisy.

When patients are harmed, lives and livelihoods are destroyed. Isn't it the responsibility of the government to first protect individual citizens from harm? Shouldn't this supersede political ambitions, industrial interests and state economics?

Perhaps the distinguished United States senators from PA, MA, MI and MN ought to be reminded that their primary responsibility is to protect American lives. As it stands, they seem poised to compromise for the sake of appeasing their states' industries. Repeal of the medical device tax, without first ensuring that this industry is safe, would be a violation of their self-proclaimed principles and of the public's trust.

Compromise is a good thing in government, unless you are talking about patient safety.

Hooman Noorchashm and Amy Reed, husband-and-wife physicians, have campaigned to ban electric morcellators since December 2013, soon after Reed's unsuspected uterine cancer was spread by the device during a routine hysterectomy.