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Home » Blogs » BioWorld MedTech Perspectives » Thanksgiving: There’s more than one kind of turkey

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Thanksgiving: There’s more than one kind of turkey

Nov. 27, 2013
By Mark McCarty

RoastedTurkey‘Tis the season to be thankful and slice into a roasted turkey with family and friends. In the spirit of the occasion, here are a few things I’m thankful for, and a few turkeys I think we could all do without.

Thankful for:

Some of the retooling of the device review process at FDA’s device center. These changes were long overdue, but we should acknowledge the agency’s budget was pretty flat for large parts of the first decade of this still-young century. It’s not easy to overhaul something on a flat budget, especially when it’s flat even before accounting for inflation.

Not thankful for:

A personnel review system that failed to filter the malcontents who were working at the Office of Device Evaluation (cough*RobertSmithMD*cough) until relatively recently. There were evidently a number of “activists” who believed they knew better than everyone else and started firing off letters to Congress and the White House in an effort to stir up trouble.

On the other hand, I’m thankful that these pea-brains are either gone or have decided to do something about their obviously delusional thinking. Here’s hoping they vet their new hires a bit more exhaustively.

Thankful for:

The three troublemakers who brought us thehealthsherpa.com. They proved that websites designed to handle complex healthcare transactions can function if one avoids larding the project down with layers of bureaucratic groupthink and endless consultations to ensure that each of the dozens upon dozens of “experts” is nodding approvingly and saying harrumph in unison (as Mel Brooks said in Blazing Saddles, “I didn’t get a harrumph out of that guy!).

They also proved you don’t have to shamelessly fleece the taxpayer in the process.

Not thankful for:

Healthcare.gov. Half a billion dollars is not your average boondoggle. It’s a boondoggle of epic proportions and will go down in history as a verification of all the suspicions many Americans rightly hold regarding the U.S. federal government’s “competence” and ethics. After all, this is the same administration that obtained the phone records of the parents of a journalist (yes, the parents of a journalist) in one of the most brazen and cynical moves by an American law enforcement agency since J. Edgar Hoover ran the FBI.

Thankful for:

Companies like St. Jude Medical, which has gone out of its way to cooperate with doctors and FDA on the problems associated with the Riata EP leads. The doctors I’ve talked to have said almost in unison that St. Jude was a model of corporate citizenship. Hats off to the leadership there.

Not thankful for:

The idiots in charge of Poly Implant Prothèse, the firm that used industrial-grade silicone in breast implants. The authorities in the various jurisdictions affected by this scandal have different views of how toxic the silicone they used may or may not be, but the PIP scandal became the rallying cry for those who want to put Europe on the same footing as the U.S. where stringent device reviews are concerned. Thus device lag is likely to affect more than just American patients, now.

Happy Thanksgiving to all, and safe travels.

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