The Center for Devices and Radiological Health may historically be the most interesting of all FDA’s branches, but the goings-on at CDRH since 2009, the year Jeff Shuren took the helm, have been nothing short of eye-popping. When one looks at the number of lawsuits and withdrawn guidances, it’s difficult to avoid the urge to characterize the past three years in terms of clichés, such as “a bull in a china shop.”
Perhaps the poster child for all this was the Menaflex 510(k), which we have discussed before. FDA’s rescission of this application was the most political move at FDA in decades as demonstrated by the agency’s explanation that the device, a collagen scaffold, was more effective at drawing in the patient’s own tissues than the clinical data indicated. So it’s too effective? That fails to address the fact that the device passed not one, but two advisory committee tests, not to mention that the device sent off no safety signals. There was also no indication the sponsor engaged in malfeasance or absent-mindedness in its filing, either, and the only two conditions under which a 510(k) can legally be rescinded are safety issues and inexhaustive application data … unless you’re Jeff Shuren, that is.
One of the really peculiar things about the Menaflex case was the number of media outlets calling on FDA to apologize for having cleared the Menaflex, which just shows a lot of people in my line of work have no idea what they’re talking about (stranger yet was that nobody in the media who criticized the device’s clearance had any problem with the towering hypocrisy displayed by New Jersey’s Rep. Frank Pallone, who first intervened on behalf of the application, then bashed FDA for having cleared it).
Regarding the 510(k) changes guidance, we note that CDRH held that it was still in force even after passage of the user fee bill in a Senate committee that shot the guidance down. That speaks of a kind of hubris that has a lot to do with the bureaucratic gridlock in Washington, but again, the media have no problem with it and the American public has no idea that device lag is a real thing and costs real lives.
Another one bites the dust: the Prevor case
The latest piece in this puzzle is the case of Prevor v. FDA, which dealt with a guidance that forced a lot of device applications to the Center for Drug Evaluation and Research. The thinking is that Shuren was behind the guidance, but it was signed by all the centers involved, so it wasn’t Shuren alone.
Let’s not forget the FDA commissioner in all this. Margaret Hamburg, MD, floated the idea of unilaterally disclosing confidential information from failed drug applications at a 2011 meeting of the Food and Drug Law Institute. So much for the notion of private property. This is a proposition that statist regimes such as Vladimir Putin’s Russia would have adored, but let’s hope that matters in the U.S. are not that far gone yet. If you think investor flight is bad now, just wait ‘til absurd notions like that start to gain traction in Washington.
The aggregate picture is not a pleasant one unless you’re a fan of command economies, and that’s a point to be taken up with firms that spend increasing amounts of time at the taxpayer-financed trough, or the highly selective device innovation program at CDRH. The word here is be careful what you wish for, because you can only eat at the trough or get a special break so many times before others begin trying to dictate everything you do, and you find yourself with progressively less wiggle room.
There’s a new world order coming yet more plainly into view at CDRH, and maybe even at FDA in general, but it’s still true that you might have to break a few things before you can make something new. That’s when a bull in a china shop is a very handy thing, indeed.
[caption id="attachment_1884" align="alignleft" width="225"] A man walks with the Kickstart Kinetic Orthosis from Cadence Biomedical.[/caption]
I have been reporting medical technology news for close to six years and one thing that has consistently amazed me during that time has been the fact that simplicity often beats bells and whistles.
The most recent example of this is the newly launched Kickstart Kinetic Orthosis from Cadence Biomedical (Seattle), a wearable device designed to help people with weakened muscles or disabilities regain mobility and independence. Amazingly, this new device was inspired by the anatomy of horses.
It turns out a researcher from the Cleveland Clinic who studied horse anatomy came up with the idea of adding a “really long spring” to help people with limited mobility walk better. Cadence licensed the technology from the Clinic and developed it from there. CEO Brian Glaster explained that horses have “really short muscles, but really long tendons.” Tendons have elastic properties that allow them to act as a natural spring in the body. Those long tendons are what make horses such efficient walkers and runners.
Kickstart is an incredibly simple device that is worn over clothing and doesn’t involve any batteries, motors, or noise. I can’t wait to see what the company comes up with for above-knee amputees.
Sometimes we can avoid irritation in our work lives, sometimes not. Sept. 20 was a day when some pretty annoying themes crept back into my workday via coverage of a session dealing with the NIH budget. Regular readers of the MDD Perspectives blog know this is something of a pet peeve of mine, but when one considers the laggardly budget at FDA, the NIH budget discussion is nothing short of mind-numblingly over the top. To wit:
During a Sept. 20 press briefing at the National Press Club, Rep. Ed Markey said the prospect of 8-10% cuts to the NIH budget could prove cataclysmic in terms of the American pre-eminence in life science research, and then went a step farther, claiming that the answer to the NIH sequestration question "will determine whether we will add to the Endangered Species Act the American scientist."
Adding to the spooky-Kabuki atmosphere was the claim by Mary Woolley, President of Research!America that if sequestration goes into effect, entire industries, including biotech, would "die here" and/or go overseas. One might expect such catastrophizing from an organization that embeds an exclamation point in its name, but still, it's just plain nuts.
I'll grant you that anyone who lives and works in the metro DC area ought to be somewhat inoculated against that kind of hyperbole, but the veracity of such claims is at least the negative-integer counterpart to the audacity of said claims. They're both clearly wrong and each of them is making up in nerve what it lacks in verifiability. Eyebrows should have fairly climbed over adjacent hairlines at such utterances, but few did.
The thing that strikes me as odd, too, is that the propaganda value of such statements is pretty close to zilch for all but the fully indoctrinated. Even the mother of an asthmatic child in Topeka, Kansas, doesn't believe such claims for a moment. So why put your credibility on the line with that kind of rhetoric?
There was an audible gasp in the room (I’m not kidding) when I asked one of the panelists about the evidence in support of the notion that the return on investment for each additional dollar spent at NIH is particularly substantial. Enter the heretic, eh? How ironic that someone who was a wallflower as a kid would ask a perfectly reasonable question and be received as an apostate working on behalf of El Diablo himself.
But that's the kind of reaction one gets when dealing with holders of votive candles murmuring at the altar of any one of several modern opiates of the healthcare masses. It's a pretty good measure of groupthink – not to mention of the complete and utter lack of skepticism – where NIH support is concerned, but it's pretty meager stuff if entertainment is your objective.
This is a theater I really should try to avoid in the future.
There’s a lot of consternation and maybe even a little constipation of late about the U.S. federal budget, and rightly so. If the White House and Congress can’t come to some resolution about budget sequestration, the FDA budget could tighten enough that user fees would disappear, which would cripple the agency. Complicating matters further is the series of tax issues – a convergence dubbed the fiscal cliff – that ripen at the end of this year, giving everyone inside the Beltway more to worry about.
This is all difficult enough without an election, so it’s easy to be pessimistic. And it’s tough to tell whether this is a game of chicken between Republicans and Democrats, or a case of lemmings of all stripes headed over a cliff.
So, how worried should we be?
As matters stand, the House of Representatives has passed a continuing resolution to fund government operations for the first six months of fiscal 2013 at roughly current levels. So far, so good, especially since the user fee calendar aligns with the federal fiscal year. All that waits now is a Senate vote, which President Obama can be safely presumed to sign.
The situation at FDA is a really outstanding reason to give the cooler heads in Washington more time at the mike. After all, there’s nothing like the specter of counterfeit drugs and devices flooding American medicine cabinets and hospitals to give a legislator a queasy stomach. There isn’t a whole lot of clarity on the question of whether sequestration would affect device user fees, as Mark Leahey, President/CEO of the Medical Device Manufacturers Association told me last week. And a lot of people would argue FDA is about as useful as a screen door in a submarine should the sequester damage or eliminate all the various user fees at FDA.
As for the tax issues that make up the fiscal cliff, I suspect the outcome will help the economy at least a little no matter which way it goes. Assuming business is still on the sidelines over unpredictability, even a tax increase would bolster some additional investment if only because everyone would then know what they’re working with. Incidentally, whoever is sitting in the Oval Office after inauguration day will get some credit for an economic boost, regardless of whether they helped (or hindered) the process.
So I think our elected officials will muddle through the budget and the fiscal cliff. Easy to say, I know, but believe it or not, all those cynical you-know-whats in Washington really do care. Besides, who wants to go down in history as the clown posse who ran the world’s largest economy into the ground?
Beyond that, anyone who needs votes to keep their job has to remember that this big a deal won’t be forgotten if they botch it, and in that event it won’t be a case of lemmings running over the cliff come election day 2014. It’ll be a case of chickens being heaved over the cliff by an angry mob. If nothing else gets Washington’s attention, that will.
There isn’t much that stays behind closed doors these days, and the case of Jim Mazzo, the outgoing CEO of Advanced Medical Optics, might be nothing more than a case of camaraderie-loosened lips … or something more toxic.
To recap, Mazzo, has been charged by the SEC with insider trading violations thanks to trades made by several former professional baseball players. The thread of the story seems to be that Mazzo told Doug DeCinces in 2008 of the then-impending move by Abbott to acquire AMO. It appears DeCinces then relayed the scoop to a couple of other former major league baseball players, who along with DeCinces bought shares in AMO ahead of the acquisition and walked away with a considerable payday for their very meager efforts.
One of the reports said that Mazzo and DeCinces met for dinner Oct. 22, 2008, and that Mazzo e-mailed DeCinces the following day “and suggested they talk.” The obvious question is, what did they talk about?
That is the question one assumes will be answered by the SEC investigation, but it’s tough to draw any conclusions just yet. One explanation is that Mazzo talked about his job regularly with DeCinces. They were neighbors, after all. Did Mazzo trust DeCinces not to say or do something stupid? Another explanation is that Mazzo knew DeCinces would use the information, but didn’t expect DeCinces to blab to his cronies.
Frankly, I find it tough to believe Mazzo would be dumb enough to run his boca if he thought DeCinces was going to do anything. After all, Wall Street got a warning shot when Martha Stewart did time in connection with shares of ImClone in 2004, just four years earlier. Did anyone in the Western hemisphere not get the flyer?
My guess is Mazzo will be hit with a fine even in the most innocuous of circumstances. Mazzo may then want to hit DeCinces with a left hook, assuming Mazzo thought he was just talking to a friend about a day on the job. Should the SEC divulge the contents of the e-mail, we may find it said something incredibly incriminating, or something such as “we really need to talk Doug. I’m getting some very strange phone calls!” If Mazzo settles out of court, we’ll never know. Ditto if the SEC drops the charges, but that would tell us pretty much everything we need to know, anyway, a statement that might apply to an out-of-court settlement as well.
I know I sound like an apologist for corporate America to some people, but I just have a hard time believing Mazzo is dumb enough to knowingly leak information he figured someone would act on. Mazzo’s reputation will be sullied in any event, though, which just goes to show that loose lips can still sink all kinds of ships.
Sooner or later, we’ll all know someone who has lost his or her life to heart disease, and today, Sept. 10, 2012, is the 20th anniversary of my father’s passing. George Edward McCarty had undergone a triple bypass several years earlier, but restenosis of the coronary arteries and an otherwise failing heart would be his undoing.
The world of medical technology has changed enormously since Dad died, so much so that what we now take for granted might have seemed miraculous in 1992. Would Dad have lived another 20 years had his predicament arisen 20 years later in medical history? It’s tough to say.
You know, it really is too bad Dad isn’t here to grouse about these things, but don’t worry. I’m happy to take care of that for him. That’s what a loving son does, right?
Stents become standard of care
One of the more pivotal advances in the field of interventional cardiology is the balloon-expandable stent, which first won an FDA approval for coronary arteries in 1994. The inception of the drug-eluting stent in 2003 deserves a mention partly because of late thrombosis. Restenosis was a big problem for some patients with bare-metal stents, though, and the DES has gone a long way to address this problem.
Dad’s first surgery was a bypass, but clearly restenosis was an enormous problem for him. Some sort of anti-proliferative might not have extended his life, but it might have done wonders for the way he lived.
I have no idea whether Dad gave his doctors a hard time, but I’m going to go out on a limb and say a little less restenosis would have given him fewer excuses to give a self-regarding MD a ration of you-know-what (as his son, I’m allowed to say Dad was good at giving people a hard time. Believe me, wherever he is, he knows it’s true).
Is the bioresorbable stent finally about to find its way into the cath lab? Maybe. How might Dad have reacted to the claim that a dissolving stent can prop open an artery that’s capable of sustaining a dozen atmospheres of pressure from an angioplasty balloon?
My guess is he’d say, “I was born in Ohio, but I’m from Missouri where this kind of thing is concerned.” Dad wasn’t always in the best health, but he possessed a healthy skepticism, and that’s putting it mildly.
TAVR finally comes ashore in the U.S.
The subhead “comes ashore in the U.S.” may sound funny, but the Sapien aortic valve for catheter delivery (a.k.a., TAVR) has been available in Europe for nearly half a decade. Edwards managed an FDA approval for the Sapien only in late 2011, and Medtronic is working to snag a PMA for its CoreValve.
I have no idea what kind of shape my dad’s aortic valve was in when he died, but I’m pretty sure he had at least some congestive heart failure, and his aortic valve could not have been in very good shape.
Incidentally, I won’t bother to explain what I think Dad would say about device lag, but I guarantee you one thing: It wouldn’t be pretty. Even I don’t want to know, and I still miss him!
There are so many more developments in the world of interventional cardiology (not to mention electrophysiology), and there are so many conversations I would love to have had with Dad, but the message here is simple. Hats off to dads and devices.
Some people think devices are overused, and one or two crackpot feminists have argued dads are superfluous. Don’t know about you, but I wouldn’t care to live in a world that lacked either of them.
The world of cardiology still holds a spot front and center in the realm of medical technology, so it only seems fitting to celebrate the birth of Michael Ellis DeBakey, MD, whose birth on Sept. 7, 1908 was followed by his passing very nearly 100 years later to the day, July 11, 2008.
In the ten decades between those two dates, the physician was published more than a thousand times in medical journals and in bound books. DeBakey’s name would become synonymous with pioneering efforts in circulatory system surgery, but the man who was born Michael Dabaghi in Lake Charles, Louisiana, would come out with his first innovation at the relatively tender age of 23, when according to the Baylor College of Medicine website, DeBakey invented the roller pump, which would collect dust for 20 years before the world realized the role it could play in the heart-lung machine.
DeBakey is also credited with having performed the first carotid artery endarterectomy, which took place in 1953, although the first endarterectomy of any kind had been performed on a femoral artery seven years earlier by Joao Cid dos Santos, MD, whose debut of the procedure is said to have taken place at the University of Lisbon.
What else you ask? DeBakey is credited with having pioneered the use of Dacron grafts, is said to have performed the first patch-graft angioplasty, and was one of the first surgeons to invite film crews into the OR to record a surgical procedure. Those who enjoy the live-action procedures routinely seen at gatherings such as TCT have DeBakey, among others, to thank for the availability of such video access.
Ironically, DeBakey suffered an aortic dissection in 2005, an event that nearly claimed his life. When he died three years later, DeBakey had unfortunately been preceded in death by his first wife and two sons, although his second wife and five other children would survive him.
Among the institutions that would also survive DeBakey’s passing is the Foundation for Biomedical Research, which supports the ethical use of animals in medical testing. Another institution of sorts, the left ventricular bypass pump, was also a product of DeBakey’s med-tech family tree.
Only occasionally is humankind blessed with the gifts of a truly rare talent – dare I say genius? – such as DeBakey’s, but his reputation is also based on longevity. DeBakey’s career spanned the latter years of the Great Depression, a world war, the fall of the Iron Curtain, dozens of congresses and a dozen U.S. presidents. DeBakey is said to have practiced medicine up to the time of his death, a standard of dedication to his craft that eclipses even his brilliance in cardiology.
Jeff Shuren, MD, has brought a lot of changes to FDA’s Center for Devices and Radiological Health, but there are those who think Shuren has not gone far enough while others think he’s gone too far. None of this would matter so much but for the potential for a GOP take-over of the White House.
It’s no secret that Shuren’s administration of CDRH has not lacked for controversy, but what some might not realize is the enormous pressure Shuren is under.
So what you say?
There are several members of Congress who are quite critical of CDRH, but maybe none more so than Sen. Richard Burr (R-North Carolina), who blasted Shuren for the latter’s criticism of industry over device application review times in a House hearing early in 2011. Burr was also less than enamored of some features of the device user fee agreement and he promised to keep up the scrutiny. Shuren also had to walk back a European patient/guinea pig remark made early in 2011 as well, a faux pas that could not have helped his image inside the Beltway given the hackles it raised on the other side of the Atlantic.
Another factor, one which many are keenly aware of, is the e-mail monitoring program undertaken by CDHR to deal with reviewers who had released confidential application documents to the White House and members of Congress. The news has not won CDRH any fans on Capitol Hill, including Republican members of both the House and the Senate. Sen. Chuck Grassley (R-Iowa) and Rep. Darrell Issa (R-California) have been nosing around into the matter, and a GOP take-over of the Senate would not render a body that looks favorably upon Shuren.
One of the sources of pressure may be the recent arrest of Bill Maisel, MD, who came on board at CDRH as the device branch’s director for science in 2010. Maisel had appeared several times on Capitol Hill to testify regarding medical device safety. He testified at a House hearing in 2009 on the subject of legislation that would have put an end to the pre-emption of state regulatory mechanisms for PMA medical devices, but perhaps worse yet is that critics of the CDRH e-mail monitoring program are alleging that Maisel had a hand in the program. Double oops.
If the GOP candidate for the Oval Office, Mitt Romney, is unaware of all this just yet, he’d probably find out about it shortly after taking office, assuming he wins in November.
Finally, the GOP platform includes a call to “reform the FDA so we can ensure that the U.S. remains the world leader in medical innovation.” The statement does not explicitly call out Shuren, but it hardly comes across as a ringing endorsement of recent goings-on at CDRH.
Still not convinced? Some will remember Tom Scully, formerly the administrator at the Centers for Medicare & Medicaid Services. Scully oversaw a lot of reforms at CMS and was himself embroiled in a number of controversies. His job at CMS lasted two years and he lost his job under the same administration that brought him into the job. Shuren is facing a different administration with an entirely different outlook on the role of government.
So the question remains: Is Jeff Shuren’s job on the line come Election Day 2012?