Well, God forbid people in my line of work should run out of things to be outraged about, but the saga of the FDA whistleblowers has boiled over again.
As readers of MDD Perspectives know, one of the members of FDA’s staff involved in all this blowing of whistles had a bad reputation before he arrived at FDA. Robert Smith, MD, made a name for himself suing hospitals for alleged overbilling of Medicare, and more recently crying to Congress and the White House that he wasn’t getting his way with his demand for PMAs for software and hardware used in medical imaging procedures.
The problem with Smith is that he doesn’t understand mammography, or so said Etta Pisano, PhD, of the University of North Carolina, who told me two years ago that she had talked to Smith about mammography. Pisano ought to know. She engineered the DMIST study that clarified that full-field digital mammography was sufficiently well understood that it could be governed with special controls rather than requiring a PMA for new units.
Just to remind you, Smith’s lawsuit against Yale New Haven Hospital over alleged fraudulent billing was dumped not just for lack of standing, but also because he couldn’t prove anything. The reason he couldn’t prove anything was that he didn’t know anything. The reason he didn’t know anything … well, I’ll let you fill in that blank.
FDA’s concerns about leaks: disclosure of confidential information
One of the concerns FDA had about Smith et al was that this business of sending device applications to Capitol Hill might result in disclosure of confidential commercial information. That’s exactly what happened as reported in the New York Times, which states that the documents were posted online “by mistake” by the company that was conducting the surveillance for FDA.
Sure, by mistake. If you believe that, you’re probably one of those people who still leaves a mug of hot chocolate on the hearth when you go to bed on Dec. 24 despite that there is nobody under the age of 25 in your home.
But here’s how the Grey Lady handled the story. FDA had “an enemies list of sorts,” but do the authors of the NYT piece ever cite an instance in which these oh-so dangerous medical devices actually hurt someone?
No, of course not, because it never happened, so it doesn’t fit in with their narrative, which goes something like this: If it’s government against industry, industry’s the bad guy. If it’s the individual (read; rabble-rouser) against government, government’s the bad guy.
Not to be outdone, Charles Ornstein and his fellow scribblers at the Association of Health Care Journalists describe the monitoring of communications between FDA and the press as “Orwellian.” Leave it to people in my line of work to raise the specter of “Orwellian” government. Please. If you think the U.S. government is Orwellian, just try and get access to government officials anyplace in Europe.
Don’t get me wrong, I have problems with the way things are run at FDA’s device branch. Just ask CDRH director Jeff Shuren. Shuren knows me by sight if not by name, and I guarantee you he remembers when Sen. Richard Burr reminded him during a Senate hearing about my article quoting Shuren as saying the slow-downs in 510(k) review times were “all on industry.”
But this time Shuren got it right. Smith and his band of troublemakers needed to be brought into line or dismissed. And please, is it not high time to take the whistles away from the children so we can all move on to things that actually matter?