We all know power struggles are part of life, but not all struggles for leverage are created equal. Following are three stories that tell us something about leverage and its many uses.
Interagency conflict over Intermacs?
The Centers for Medicare & Medicaid Services recently announced it would no longer require hospitals to forward data from their patients with ventricular assist devices to the Intermacs registry. Depending on whom one asks, that’s a plus for hospitals, but the flip side of that particular coin is that another registry will have to take it’s place.
The problem with CMS seeming to pull the plug on Intermacs is that the National Institutes of Health also has a stake in the registry, and there’s not much indication NIH is also ready to pull the plug. NIH still publishes annual updates to the contents of the registry, such as this report published earlier this year in the Journal of Heart and Lung Transplantation.
Note also that the name Intermacs is an acronym for Interagency Registry for Mechanically Assisted Circulatory Support. Clearly there’s a big potential for a turf war here, especially given that most cardiologists think there’s still a need for a registry for ventricular assist devices.
Demurring on da Vinci
Intuitive Surgical has a raft of lawsuits on its hands over the use of the company’s surgical robot, the da Vinci, but a recent FDA report did not seem terribly incriminating of the device’s design or manufacture.
FDA announced Nov. 8 that it was “aware of an increase in the number of medical device reports” associated with computer-assisted surgical systems, stating that the majority of the reports the agency received “were of device malfunctions,” including “component breakage, mechanical problems and image/display issues.”
On the other hand, FDA also said that much of the up-tick in reports of injuries and deaths associated with the device may be due to “increased publicity resulting from product recalls, media coverage, and litigation.” The agency went as far as to say that adverse event reports “can contain incomplete, inaccurate, duplicative, and unverified information,” and that the mere filing of a report “does not necessarily indicate a faulty or defective medical device.”
Somehow one doubts seriously whether the trial bar will be even slightly put off by the news. One also wonders when some brave surgeon will admit he or she screwed up, and that it wasn’t the device’s fault at all.
Ah, doctors and lawyers. Amazing.
Aghast over Avandia
And finally, we note that FDA has withdrawn its restrictions on Avandia. FDA stated in its Nov. 25 announcement that the data from the Record trial “showed no elevated risk of heart attack or death in patients being treated with Avandia when compared to standard-of-care diabetes drugs.” FDA stated further that the data “do not confirm” the reports of a greater risk of heart attacks as described by Steve Nissen and Kathy Wolski in their study appearing in NEJM in 2007.
This is actually two tales. One tale is that of a medical stampede, not toward a drug or device, but away from a drug or device. Ironically, the molecular entity behind Avandia went off patent last year, so the news comes just in time for generics makers to cash in.
The second tale is that despite the fact that Nissen was clearly mistaken, he went full bore with a conspiracy theory argument in the Wall Street Journal earlier this year when FDA announced it would hold an advisory committee hearing on the drug. A conspiracy of common sense, one supposes, is no less a conspiracy.
The number 23 is an interesting number. It’s a prime number, and is the number of pairs of chromosomes in human DNA, but it may also become a number FDA won’t soon forget.
FDA recently issued a warning letter to 23andMe, ordering the company to stop offering its gene testing service pending further evaluations of the tests. Then a petition popped up at the website for the White House to require FDA to back off. The petitioners argue the agency “grossly overstates the risks” associated with the test, adding that consumers understand those risks.
I won’t pretend to know what specifically FDA objects to regarding validation of 23andMe’s tests, so I can’t say whether the agency is overreacting. Still, it’s not first time FDA has been accused of overreach, and won’t be the last.
One of FDA’s biggest PR problems has nothing to do with the agency’s past. The biggest problem might be all the things the federal government has done over the past couple of years that have provoked the American public. One of these is the shutdown showdown between the GOP-led House and the Obama administration, but perhaps more damaging is the NSA surveillance disclosures.
But let’s not forget the spying on journalists by the Department of Justice, the very selective review of conservative 501(c)(3) organizations by the IRS, and the Obama administration’s interpretation and re-interpretation of events in Benghazi. The coup de grace is President Obama’s promise that “you can keep your insurance” despite clear indications he knew better.
All this has fed an appetite for libertarianism like nothing any of us has ever seen, which might not be a bad thing. For instance, libertarian candidates are making a run at the city council for the District of Columbia of all places, and a range of publications are taking notice of a surge in voter identification with libertarian political viewpoints.
All this comes at a time when the usual foreign policy and security challenges are surfacing with regularity, including that mainland China is itching for a fight over the South China Sea. Those in government who feel they know better than the rest of us what’s good for us are not only guilty of supreme hubris, they’re also eroding confidence in government at a time when our security and foreign policy challenges still demand our government’s undistracted attention.
Otherwise, people will die needlessly again.
I recently had an online conversation with a relative who said most Americans are too stupid to know what they need and that hence the balance of power between the public and private sectors must shift toward the public sector to ensure our well-being. That’s precisely the paternalistic attitude behind government overreach. If the citizens who work in government don’t get over their you’re-stupid-I’m-smart approach to their jobs, they are going to destroy what little faith we as a people have left in government, as a recent poll demonstrated.
These self-appointed geniuses have the same DNA as everyone else and hence are prone to the same kinds of delusional thinking that plagues the rest of us. It’s just that these technocrats are in a position to bully the rest of us while hiding behind a wall of anonymity. And that’s the very thing that makes acronyms like NSA, IRS and FDA quite dangerous in the wrong hands.
And thus we have two times 23 more reasons we should be very careful about FDA, and indeed of all of government. I wonder if 23andMe can test for a gene for towering arrogance.