FDA is out of step

09/01/2007

Sometimes epiphanies just jump out at me. For example, here’s one that just came to me recently. Why is the FDA continually sending out those public reports about various food and drug manufacturing companies that have failed this or that safety or quality inspection? Clearly, the agency is not giving adequate consideration to the inevitable big-picture consequences of such actions. I mean, has the FDA considered the potential liability that they are exposing these companies to from nefarious trial lawyers, or even the lack of faith and confidence that such reports will undoubtedly engender within the public at large when they hear about the health risks posed by these outed companies and the products they provide?

This is just not the way things are done these days, and I don’t understand why the FDA doesn’t take a few pointers from many of the state legislatures and boards of health across the country, where, far from going around willy-nilly handing out information to the public about the rate of hospital-acquired infections at individual hospitals, the state boards are quite responsibly keeping this information to themselves. What possible purpose can it serve to release this kind of disconcerting data to people trying to make an intelligent decision about where to take their loved ones for medical treatment? Isn’t it far better that they simply announce that while yes, thousands of people are dying from HAIs each year in their states, steps are also being taken to address the problem? There’s no reason to go singling out any particular hospital for criticism just because patients are dying there at a rate three to four times that of the institution down the street. After all, isn’t it enough that everyone is working on the problem to some extent?

Take Massachusetts, for example, where the state public health commissioner acknowledges that although his agency certainly has the authority to mandate the reporting of infection rates, his preference is for hospitals to provide it voluntarily. Quite sagely he observes that “we don’t want to overburden the hospitals with a heavy-handed regulatory requirement.” Well said, especially since, according to a state report released this month, Massachusetts hospitals are already overburdened to the tune of up to $473 million in medical costs annually from infections acquired in the state’s health-care facilities. What possible good can come from reporting the state’s share of the 90,000 patients who die annually in the U.S. from HAIs, or at which particular institutions they mostly died? This is the same good thinking guiding New York State’s Department of Health, which-while dutifully reporting the individual HAI data it collects-will not be identifying the hospitals it relates to.

California is even more responsible in its approach to reporting. Instead of boring the public with tedious infection rate data, this forward-thinking state will only be reporting the rate at which prevention practices are being implemented. Now that’s sensible, and painless.

The fact is that a great number of states have come up with all manner of clever ways to address the public’s concern about HAIs, which don’t include public reporting by facility. Isn’t it time for the FDA to follow their lead and stop with all the finger pointing? I mean, what we don’t know can’t hurt us. Right?

John Haystead,
Editor-in-Chief