[caption id="attachment_3681" align="alignleft" width="251"]Ridin' herd ain't what it used to be.[/caption]
The life sciences have fostered an environment that can get pretty crazy, but let's face it: That's one of the things we like about the life sciences. Below are two stories that rival the tallest tales told of the Old West, but these two stories happen to be true stories.
Hamburg; clinical trials for Ebola
The latest outbreak of Ebola has generated a few rhetorical whoppers by elected and appointed officials. One of the weirder among them is a remark by FDA Commissioner Margaret Hamburg, who said in a recent blog at FDA Voice that the agency “strongly” supports clinical trials for Ebola vaccines and treatments.
Color me chicken, pardner, but there is no way in the world I'm going to consent to be randomized in a trial for a vaccine or a treatment for a cold-blooded killer.
However, the idea of a non-randomized trial for Ebola doesn’t make much more sense than a saddle without stirrups, either. For starters, the current outbreak will be well past done by the time any trial has a chance to make it out of the barn. Then you have to ask yourself whether the next outbreak will present a virus with the same surface proteins and other characteristics as the current outbreak. If the answer is no, any diagnostic, treatment or vaccine currently in development mightn’t lasso the critter.
Care to sink your hard-earned coin into that kind of ranch? I wouldn’t.
Cook Medical’s warning letter
Cook Medical is a big wheel in the device business, and certainly has the pockets for a top-notch compliance staff. But as we have seen in the past, even big companies with deep pockets sometimes don’t ride their herds very well.
The September 16 warning letter to Cook addressed the plant that manufactures catheters and other devices, stating that the company had identified more than 700,000 non-conforming livestock "across all device families" over a stretch of about two years. Among the problems were labels that seemed to fall apart, and a process that did not do a particularly good job of bonding catheter tips to the catheters.
There was one recall of the company's devices that took place during the period in question, the Zilver PTX stent for the peripheral vasculature. The company said in its May 2013 statement that the rate of catheter tip separation was 0.043%, which to the greenhorn sounds like a good rate.
Still, Cooke had to trash more than half a million devices due to the non-conformities, which can't have been cheap.
However innocuous these problems might have been, device makers have to understand something about Sheriff Jeff Shuren. He and the rest of the agency have no breathing room (from the media or from Congress) when it comes to problematic medical devices. If a device maker has a problem that seems a minor problem, the real question might be "would this be a problem for Johnny Law?"
If the answer is “yes” – even if it’s just a problem of optics where the townfolk are concerned – then it's a problem for the device maker, too. If you’re in the device industry, you simply cannot let wild horses run loose in your corral. Your ranch is regulated. Tightly. And please, no excuses. It’s not as if you didn’t get the flyer.
Physicians and surgeons are going to flock to Google Glass. That's my bold prediction and I'm sticking to it.
I mean come on, just look at the impact the i-Pad has had on healthcare facilities across the country - sorry world. Now one of the main reasons Google Glass is going to make a strong impact, is because of it gives surgeons access to patient information and apps, at the benefit of freeing up the physician's hands.
It's a common sense selling point, that I missed when I demo-ed the technology about a year ago. But what brought this fact into focus was a recent interview I did with Cara Liebert, a general surgery resident and surgical education fellow at the Goodman Surgical Simulation Center at Stanford Hospital. Liebert was also part of a study that used Google Glass to monitor patients' vital signs.
During the interview, Liebert mentioned that "for a surgeon it means that [Google Glass] can be used when you're scrubbed in a sterile procedure and your heads are occupied during the operation." A light bulb went off, it was a genuine aha moment. And it brought me back to concerns about properly sterilizing an i-Pad or an electronic tablet when in the operating room. Google Glass could have the potential to substantially cut down or reduce the rate of possible infection.
Pretty soon, in probably the next five years or so, nearly every physician is going to be wearing this stylish eye wear.
[caption id="attachment_3647" align="alignleft" width="177"]Different uniform, but he carries a stick, too[/caption]
There is certainly no shortage of stories (or controversy) in the world of med tech, and here are a couple of stories that kept a lot of people glued to their computer screens (more or less) recently.
FDA watches the Watchman
FDA has heard a third affirmative vote from an advisory committee on the question of the Watchman left atrial appendage closure device, although the vote in favor of the device was close for the second consecutive time. It’s an interesting predicament for the agency because members of the Office of Device Evaluation are clearly uncomfortable with the Watchman, but it’s becoming increasingly difficult for the agency to dismiss the views of physicians.
However unsettling FDA’s misgivings might be, it does not have to go it alone. It has a safety net called the Centers for Medicare & Medicaid Services, which along with FDA provided a case study for inter-agency coordination with their handling of the transcatheter aortic valve (a.k.a., TAVR).
We note, however, that CMS had to cough up more for the Edwards Sapien device within a year of rendering its coverage decision because some perfectly qualified centers couldn’t use the device without losing money. We might reasonably expect the same kind of loopy governmental behavior for the Watchman, which has been available in Europe for how long?
In any event, Boston Scientific won’t have the market to itself for long. St. Jude Medical is working on the second iteration of the Amplatzer device, and these are not the only companies working on this kind of technology. FDA won’t have to watch the Watchman for long.
Industry watches the device classification rule
It’s not often a regulatory writer remembers a med tech draft guidance or proposed rule with a lot of clarity (FDA turns out so many of them). But who can forget the announcement in the March 25 Federal Register for device classification procedures?
There’s a ton in there, and my write-up in the March 26 edition of Medical Device Daily didn’t come close to covering it all. One of the more obvious examples of saber rattling was FDA’s observation that some stakeholders think clinical trials are great special controls for class II devices. I said in my write-up that FDA “has 90 days to take on the near-certain rebellion the rule seems destined to provoke.”
Did I go out on a limb with that observation? Maybe, but the agency extended the comment period to Sept. 22, and there hasn’t been much noise about it in the nearly four weeks that have since passed. The draft rule discusses matters such as a class III device designation based on “heightened potential risk,” which strikes this scribbler as highly elastic language. And that’s far from an exhaustive reading of the document.
It seems unlikely that this proposed rule will just die off gracefully, but it will be trimmed back by quite a bit. A good example of FDA’s regulatory ambitions and the attendant resistance is the guidance for distinguishing between device recalls and improvements. I won’t go into details, but it’s tough to avoid the conclusion that FDA now sees draft guidances and proposed rules as opening gambits in a negotiation.
[caption id="attachment_3616" align="alignleft" width="320"]Max headroom at McCormick Place[/caption]
The annual meeting of the Advanced Medical Technology Association, or AdvaMed, doesn’t include a lot of mind-blowing news, but there are often developments worthy of note.
Following are a trio of stories addressing what was (not) said, and a few things to watch for over the next year or so.
Physician payment sunburn?
As reported by Medical Device Daily executive editor Holland Johnson in the Oct. 8 edition of MDD, Covidien’s chief medical officer Michael Tarnoff had a few interesting observations about sustainability. Tarnoff said docs are accustomed to getting what they want, but that the push by payers for more evidence will cut into those wish lists.
On the other hand, the doc payment database mandated by the Physician Payment Sunshine Act has Tarnoff concerned that physicians will kiss device development goodbye. Not a good move, said Tarnoff, because device developers will be “flying blind without healthcare professional input.”
Are Tarnoff’s fears well founded? I guess we’ll see, but AdvaMed did argue a week or so back that CMS was not including all the data supplied by industry and that hence the doc payment sunshine database lacked context. Now we get to wait and see how long it takes for the New York Times to report something outrageous, only to discover later it was much ado about nothing.
Tax inversion introversion
Covidien again appears in this week’s blog, with CEO Joe Almeida appearing at the Oct. 6 AdvaMed presser. The session was replete with the usual stuff about the device tax along with an article about private payers making greater use of financial metrics.
Almeida understandably ducked a question about tax inversion. He’d have to be a prize fool to wade into that one, given how much noise there’s been about inversion and Medtronic’s in-the-works acquisition of Almeida’s employer.
AdvaMed chieftan Steve Ubl did say that the association welcomes the inversion debate to the extent that it shines a light on the corporate tax reform impasse. Looming in the not-too-distant future is the prospect that a slight GOP Senate majority in the 114th Congress might lead to the use of budget reconciliation rules for passage of tax reform.
The 15% non-solution
One really good way to screw up a device clinical trial is to under-enroll, an increasingly conspicuous problem these days at advisory committee hearings. One of the sessions at AdvaMed 2014 tackled the clinical trial problem in the U.S., and Chip Hance of Ireland’s Creganna-Tactx Medical said 15% of trial sites enroll zero patients in the typical clinical trial.
I hate to confess ignorance, but that was news to me. Nearly one in seven? Which administrator at these sites is signing up their doctors for a trial when they’re not going to participate?
Roxanna Mehran of the Cardiovascular Research Foundation said one feature of this dilemma is that study coordinators may be tempted to find reasons not to enroll subjects “because that’s less work for them.” If that’s the case, it suggests that about 10% of the clinical trial sites in the U.S. could disappear and nobody in the device business would be the wiser.
[caption id="attachment_3585" align="alignleft" width="320"]When it comes to accountability at FDA for the Menaflex imbroglio...[/caption]
As is widely known by now, FDA lost the second round of the legal struggle over the Menaflex 510(k), but the decision at the Court of Appeals for the District of Columbia sends the application back to FDA, where the device awaits an uncertain fate. Will FDA appeal to a higher court? I doubt it.
The Menaflex story is one of the more convoluted med tech stories of the recent past. The first sponsor of the product, the now-shuttered ReGen Biologics, initially filed it as a PMA, but switched to a 510(k) after similar devices were cleared for other parts of the human anatomy.
Staff at the Office of Device Evaluation chipped in to the melodrama by declaring the device not substantially equivalent on the first pass, which everyone at ODE knows is a no-no. On the other hand, ReGen’s management was not the easiest to get along with by some accounts.
Pressure to clear, pressure to rescind?
Then of course there’s the involvement by the New Jersey congressional delegation, with which the latest court decision evinces no discomfort at all. And let’s not be outraged by that. It wasn’t the first time and most certainly will not be the last, and there’s a reason the private sector can complain to Congress about FDA. It’s their right to complain to Congress, so please, no sniveling over that one.
The Centers for Medicare & Medicaid Services already decreed it would not pay for the Menaflex, which immediately removed a huge chunk of the potential market for use in knee osteoarthritis. That wouldn’t stop private payers from covering the device, although they would have a tough time doing so given that efficacy data for the collagen scaffold were iffy. So why not just let the market decide?
One of the problems with the optics for FDA is that the Menaflex was one of the devices targeted by the FDA whistleblowers in letters to Congress and the White House in 2008 and 2009, which casts the Menaflex as the easy target for proving that FDA does its job. Another “optical” issue is that both advisory committees recommended FDA allow the device on the market, in part because of an impending wave of knee replacements as the Baby Boom ages. If memory serves, ReGen had priced the Menaflex at about $2,000, which is a lot cheaper than a knee revision surgery.
Congress provides an out
I wrote three years ago that FDA may find itself on the losing end of this debate, but all that changes with the Food and Drug Administration Safety and Innovation Act, which gives FDA greater leeway in up-classifying medical devices. Prior to FDASIA, the statute did not give the agency the right to just summarily rescind the clearance because to do so amounted to an up-classification, which required rulemaking.
Here in the post-FDASIA world, however, FDA can use its administrative leverage to say “class III” and that will pretty much be that. Still, the agency was part of the reason this turned into such a nightmare to begin with, and it has yet to acknowledge the primacy of its role in this mess. Instead of standing up and saying “we needlessly put a company out of business,” FDA continues to insist that it acted properly in rescinding the clearance. FDA’s continued gamesmanship is ironic because it always postures itself as the morally upright guardian of the public health. It turns out FDAers are just as political as anyone else in Washington.
There’s one conclusion that is difficult to avoid in all this and it’s that FDA’s handling of the Menaflex was nothing but a cheap piece of regulatory railroading on the agency’s part. The public deserves better.