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The story has been out for a while about transcatheter aortic valve replacement (TAVR), so maybe it's time to project into the future. Before we head there, however, we should revisit the past.
The pivotal event in this story is the drug-eluting stent, a device that gave birth to what FDA's Bram Zuckerman, MD, described as the DES trauma. The DES story is twofold; rapid physician adoption and late-stent thrombosis (LST).
FDA saw the rate of adoption as an unruly and harmful stampede because of LST, but thrombosis was not the prime driver of the development of DES. Restenosis was. As of 2008, the rate of thrombosis in DES at 24 months roughly matched the rate in bare-metal stents, although first-generation DES units held it off until after a year whereas thrombosis in BMS units almost always took place within 12 months. Still, the episode sparked a lot of anxiety at FDA about other devices.
This leads us to the Sapien aortic valve made by Edwards Lifesciences, which snared an FDA approval in 2011 roughly four years after its approval in Europe and which the Centers for Medicare & Medicaid Services is still deciding how to cover. The central feature here is that both agencies are considering a very strict deployment which not only stipulates the involvement of at least half a dozen physicians, but also limits the use of the device to 100 or so centers in the U.S. By the way, this is the perfect way to virtually outlaw off-label use.
In the meantime, Edwards is working the U.S. pivotal trial for the slimmer Sapien XT, which already bears a CE mark. Ironically, Edwards no longer sells the original in Europe, but the most conspicuous aspect of the Sapien's FDA approval is how dependent it was on three medical specialty societies whose involvement gave FDA the framework for the restrictions the agency placed on the device. Regardless of whether one sees it as a quid pro quo, the conditions FDA imposed on the device's use guaranteed doctors that lots and lots of them would be able to grab some of the jingle that will accompany the device's roll-out in the U.S. market.
Whether that works for CMS's attempts to rein in costs remains to be seen, but the trade-off appears to be that CMS will pay more doctors per valve in exchange for fewer valves. I'm pretty sure this agency knows what it's in for and is confident it won't be in the red when all is said and done.
There may be several messages here, but what this says to device makers with a first-of-a-kind interventional cardiology device – perhaps a first-of-a-kind implantable device of any sort – is “get in bed with the medical specialty societies because you will not get to market otherwise.” Physicians already have control over the CPT codes used by CMS to determine Medicare coverage, and they now have much more sway over FDA's regulatory approval beyond their traditional role as advisory committee members.
It's tough to avoid the conclusion that doctors are relieving both agencies of a lot of difficult political work and are taking home a nice chunk of change for their troubles. In any event, doctors are more deeply entrenched than ever as another set of gatekeepers and now constitute a third regulatory entity device makers must engage “early and often,” as they say at FDA, in order to get to market. And that's what TAVR says about FDA and CMS.
I've attended more FDA advisory committee hearings than most and believe I have a decent grasp of how those hearings should go. It's true I'm no expert, but recent hearings for medical devices have gone in a direction that strikes me as odd.
For instance, at the Jan. 11 meeting of the gastroenterology/urology devices committee, FDA's Herb Lerner, MD, addressed post-market study requirements for an application filed by Torax Medical of St. Paul, Minnesota. Among the items of discussion that day were quality-of-life scores for gastroesophageal reflux and measures of esophageal pH.
Lerner said: “This is a very interesting question in that it would sort of lead to a discussion of what if another device came down the pike, would this be enough for the next device to come in? Would this be enough for us to go ahead with a trial?” You can find the transcript here.
Even if regulations do not forbid such things, the ethic at advisory panels has always been that the panel is to consider that specific application with no regard for things that may “come down the pike.” Lerner told me afterward his query was strictly “exploratory,” but it seemed as though he was asking the panel members to make a decision based largely on future applications. Am I reading too much into it?
Another example occurred at the advisory hearing dealing with the regulatory status of cranial electrotherapy stimulator (CES) units. As I wrote in the Feb. 14 edition of Medical Device Daily, the Feb. 10 hearing “was conspicuous for two events.” At the conclusion of the hearing, a member of the audience approached the podium after the vote and criticized the panel's decision, but FDA staff instructed the audio team to kill the microphone before Les Hamilton of Silver Spring, Maryland, made his views known.
FDA seemed less concerned when panelist Murray Stein, MD, of the University of California San Diego (San Diego) left the room to call someone he knows the National Intrepid Center of Excellence (NICoE) at the Walter Reed Army Hospital to rebut a claim that NICoE uses CES systems.
Stein claimed his contact said the center has never used CES systems, but his statement was contradicted by several in the audience who were not allowed to respond, including Stephen Xenakis, MD, a retired U.S. Army brigadier general. Xenakis told me in an interview, “I know it's used at NICoE because I've talked to them about setting up projects” associated with such devices. I also contacted NICoE and public affairs officer Joshua Stueve confirmed the device is indeed in use there.
My impression in this case is that FDA allowed Stein to do something a sponsor could never get away with and provided the panel with information that is just plain wrong, but I get it if nobody cares what I think. I have no skin in this game and I'm no expert.
Just out of curiosity, though, does anyone see a problem?
We already know that a picture is worth a thousand words, but did you know it might also be worth a thousand calories? A new smartphone application is being developed at Purdue University (West Lafayette, Indiana) to help the health and diet conscious track their caloric intake by taking a picture of their food.
This caught my attention for two reasons: One, I’m sort of turning into a health-app junkie. I am currently tracking every bite of food, every visit to the bathroom, every headache, my sleep patterns, and my menstrual cycle. Oh yeah, and I check on my heart rate once in a while too – all with my beloved iPhone. Secondly, there are already dozens of fitness and calorie tracking apps but none, to my knowledge, that can identify the type of food, amount of food, and nutritional value with simply a picture of it. That’s what this one promises to do.
As someone with significant dietary restrictions, I can certainly see how an app like this would come in handy for anyone with food-related health challenges, like diabetes.
Purdue’s app is being developed as an interdisciplinary project. They have a professor of electrical and computer engineering in charge of the imaging software development that is supposed to automatically identify the foods in the images. They also have a professor in the Department of Agriculture and Biological Engineering in charge of the food density part of the application in order for the app to be able to determine the nutritional value.
So will it work? I don’t know, but I’ll keep an eye out for it to become available and will let you know.
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There are many definitions for the word “crazy,” and here's another. Crazy is when you want to get out of Medicare and save the government and the taxpayer money, but the government won't let you.
Recent reports indicate that a group of five senior citizens, including former Texas Republican congressman Dick Armey, are okay with their Social Security benefits, but that the law is forcing them to enroll in Medicare Part A if they want to stay on Social Security.
The case made it to the Court of Appeals for the District of Columbia, and maybe the fact that the case was in DC should have tipped everyone off. After all, DC is the jurisdiction that passed a law stating that the city's rats could not be killed, but had to be trucked 25 miles away from the city and released on the unsuspecting citizens of Virginia and Maryland.
In any event, Judges Brett Kavanaugh and Douglas Ginsburg are said to have told the five seniors, “we're sorry. We get it, but the law doesn't.”
Between Medicare and Social Security, Medicare is expected to cost much more in the years to come, but instead of allowing retirees to take just Social Security and leave the Medicare money on the table, everyone has to take both or neither.
One might assume there is no mass exodus from Medicare among impending retirees, but what sane person would take Medicare over private insurance? Let's assume one of every 10 Baby Boomers can stay on their private insurance for the rest of their lives. If you assume there are 78 million Boomers, that's 7.8 million who might forswear Medicare.
According to the Kaiser Family Foundation, the average Medical cost per beneficiary is more than $8,300, and Kaiser also suggests that Part A accounted for 41% of Medicare spending in 2007. That would come to roughly $3,300 per year. Multiply that average cost by 7.8 million and you get how much in savings by dropping this requirement?
About $25.6 billion per year, that's how much. But even if only 5% of Boomers could carry private insurance until death do part them from this world, that's more than $12 billion a year. If you assume those Boomers will last about 20 years after retirement, hardly a stretch of the imagination according to CDC, we're talking $120 billion at least, maybe $250 billion.
Whichever number you choose, that's a lot of money. It might not be enough to fix the Medicare financing mess, but there is no one adjustment that will. But hey, let's not mess with success, shall we? Government rules are what got us here, so why not roll with it?
Oh yeah, another definition of crazy? Doing the same thing over and over again and expecting a different outcome. Now that's just crazy.
It’s doubtful that Britney Spears’ 12-year-old hit single, Oops! . . . I did it again, entered into Roche’s mind when the firm disclosed a hostile takeover bid to acquire Illumina late last month for $44.50 a share in cash, or about $5.7 billion. Okay, maybe doubtful isn’t the right word. Maybe I should say that there was no chance in the world that Roche even considered this song when describing its takeover bid.
But to those who have followed Roche closely throughout the past few years, the song seems to fit Roche’s attempts to acquire the DNA sequencing company perfectly. The comparison gets remarkably easier when one remembers that back in 2009, Roche acquired U.S. cancer drug maker Genentech using a similar strategy.
Roche ended up acquiring Genentech for about $46 billion in cash – or about $95 a share to acquire the remaining 44% of the company that it did not already own. This move ended a hostile takeover bid that stretched out for months.
Prior to the acquisition, a special committee of the board of directors of Genentech urged the company's shareholders to take no action at that time with respect to the hostile tender offer commenced by Roche to acquire all of the company's outstanding shares not owned by Roche at a price of $86.50 in cash per share, which was $2.50 less per share than what Roche originally offered to buy the company for previously.
So far in the Illumina deal – Roche isn’t having an easy go of it. Illumina's board has adopted a "poison pill" defense strategy against the hostile takeover bid, saying it would trigger a rights agreement if any party bought 15% of its stock.
In addition to the poison pill, Illumina also has a so-called staggered election for its board of directors, which makes it difficult for an outside party to gain control of the board in one year.
Roche may be facing a drawn-out battle after Illumina reported the rights plan, which typically allows a shareholder other than the bidder to buy more shares at a discount, often with the aim of forcing a higher offer or deterring a bid because of the higher cost of acquiring the extra shares.
If anything can be learned from the Genentech deal, it’s that Roche is willing to go the distance. And why shouldn’t the firm do this? If this acquisition comes through then Roche could have a bigger slice of the ever growing personalized medicine pie. Also, it’s not like we haven’t seen the company go a few rounds to complete an acquisition before.
Long and drawn out – been there. Ready to dole out a few billion dollars to complete the acquisition – done that.
It probably won’t be that much longer before Spears’ pop classic is echoing loudly throughout the halls of Roche – well, figuratively speaking that is.
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Fans of pro football may think the matter of whether Peyton Manning will ever play in the NFL again is taking forever to come to a conclusion, but they might want to examine the FDA whistleblower issue as a benchmark for drawn-out drama.
As has been reported in Medical Device Daily, former FDA employees, including Robert C. Smith, MD, and Julian Nicholas, MD, were among the authors of letters to Congress and the Obama administration over alleged suppression of dissent over medical device approvals. Those letters came out in 2008 and 2009, and the story of a new lawsuit by some of the authors of those letters against FDA is all over the Internet. The lawsuit alleges that FDA's practice of monitoring e-mail communication on agency computers violated the privacy rights of the senders.
Smith is quoted in the Washington Post piece as saying (apparently in outrage): “Who would have thought they would have the nerve to be monitoring my communications to Congress?” He is said to have inquired further: “How dare they?”
Well, it seems FDA dares. The reader will pardon me for editorializing, but if your employer tells you up front that your computer activity may be monitored, you probably ought not use those computers to send out things that could get you in trouble.
As the saying goes, “duh.”
So what gives with the kindly Dr. Smith & Co.? Tough to say, but Smith had filed a whistleblower lawsuit against Yale New Haven Hospital (YNHH; New Haven, Connecticut) and several other hospitals that was dismissed in 2006. A few items in that decision are of special interest in this discussion, including that “the United States declined to intervene in the action.”
The decision states that Smith's allegation that the hospital's use of an autosign program disallows billing for the technical component of a radiological study ignores the separation of the technical and professional components of Medicare billing practices. The decision notes that the relator's (Smith's) argument would disqualify YNHH from being paid for services it had rendered “if the physician's request or intended use of the study, deemed before the fact to be medically necessary, was found after the fact to be medically unreasonable and/or unnecessary.”
Other passages include that the relator “has failed to establish … subject matter jurisdiction over his claims” and “has not demonstrated that he is an original source of the facts on which his claims are based.”
Also in the text are the passages, “the allegations … are fraught with assumptions and conclusions which do not suffice to establish the essential facts” of a whistleblower claim, “and are devoid of the facts necessary to support such a claim.”
The decision also says that what the relator “alleges to be his observations are not shown to be within his personal experience,” and that his claims do not reflect “first-hand knowledge” or “direct, independent knowledge.”
As they say in the movies, capisce?
As my wife will tell you, I'm sort of inclined to crack wise at a lot of fuss and bother and can be heard asking from time to time, “what's so mellow about melodrama?” So maybe I'm the wrong person to blog about all this. But still, the only question I have about this latest Smith-based dust-up is …
What's Peyton Manning going to do?