There is an Irish aphorism which states: "Anything that keeps a politician humble is healthy for democracy." The same might be said of bureaucrats. What sometimes strikes me as odd is that you can easily find coverage of the miscues of corporate America, but few media outlets are as punctilious about reporting on government's ill-intended moves.
Here, then, are five reasons to mistrust government at least as much as device makers.
Five: The Thompson Memo
In 2003, this memo directed federal prosecutors to offer leniency to a corporate defendant if the defendant was willing to waive attorney-client privilege and/or willing to withdraw financial support from the legal defense of any executives charged individually.
Can someone tell me how this was not blackmail? L'etat, c'est moi saith the government lawyer. Thankfully, Thompson's successor yanked this totalitarian-inspired power-grab three years later.
Four: HHS pummels and muzzles insurers
The Department of Health and Human Services announced in a Sept. 9, 2010, statement that private insurers should “stop using scare tactics and misinformation to falsely blame premium increases" on last year's healthcare reform bill. Secretary of Health and Human Services Kathleen Sebelius also reminded health plans that the states had “new resources under the Affordable Care Act to crack down on unjustified premium increases.”
Meanwhile, HHS went on a spending spree with promotions backing the Affordable Care Act. The message here was “freedom of speech is for government only.” Such heights of hypocrisy are rarely seen even in Washington, and this was a breathtaking example of the maxim that nothing exceeds like excess.
Three: FDA rescinds Menaflex after two panels say 'aye'
FDA cleared the Menaflex 510(k) by ReGen Biologics (Hackensack, New Jersey) after the device won over an advisory committee, then rescinded the clearance after a second advisory committee drew the same conclusion. The agency's explanation was that the device did a better job of encouraging the patient's body to fill in behind the excised cartilage than the company's application suggested. That's not a terribly convincing explanation.
FDA has to recognize that assembling the second advisory panel only to ignore its recommendation suggests the agency hoped the advisory committee would handle the dirty laundry. If you dislike the congressional meddling in this case (this is far from the first time such a thing has happened, by the way), you still have to address an outstanding safety record in routine European usage and in U.S. clinical trials, not to mention the fact that this device met an unmet need.
Now the Menaflex meets an unmet need everywhere but in the U.S. In the minds of many, the explanation is that the new regime at FDA was settling a score, and nothing has happened in the interim to dissuade anyone of that view.
Two: Federal prosecutors' ginned-up case against Lauren Stevens
The case against Lauren Stevens, an attorney with GlaxoSmithKline (London), ended in a gigantic embarrassment for the U.S. Department of Justice. A local federal prosecutor, Rod Rosenstein, evidently deigned not to sign onto because, according to a June 20 article at Law.com, Rosenstein “didn’t think there was enough evidence to support the charges.” Sue Reisinger writes also that the jurist handling the case, Judge Roger Titus, said “the defendant in this case should never have been prosecuted." Once again, a government official goes overboard, but was this a firing offense?
Apparently not because a web search of the names of the two attorneys identified as the avenging angels of DoJ, Patrick Jasperse and Sarah Bloom, come up with nothing indicating the department has given them their walking papers.
Try keeping your job in the private sector with that kind of performance.
One: Obama administration recruits snitches
The Obama administration's blog for August 4, 2009, complains “there is a lot of disinformation about health insurance reform out there,” much of which “travel[s] just below the surface via chain emails or through casual conversation.”
Then the White House asks citizens, “if you get an email or see something on the web about health insurance reform that seems fishy, send it to firstname.lastname@example.org.”
Ignoring for the moment that this clearly includes personal email communications, I'll ask a question: Why mention “casual conversations” at all if you're not trying to prompt people to tell the government about the contents of casual conversations?
The message here is that if you think the private sector is riddled with pernicious, ill-gotten behavior, just consider what our government has been up to for the past decade. So much for the humility of our elected and appointed government officials.