First let’s examine the obvious. The chatter about demonstrations of efficacy as a requirement for a CE mark has been going on for some time, and the flap over breast implants made by Poly Implant Prosthèse has generated quite a bit of support for tighter scrutiny of devices in Europe. The problems with metal-on-metal hip implants and electrophysiology leads have pushed this agenda, too.

One should bear in mind that elected officials have large patella tendons where such things are concerned, especially when the mainstream media coverage prompts calls from constituents. That has been true in the U.S. for decades and one suspects it is becoming more the case in Europe as well.

European Parliament getting nervous

Don’t believe me? Take a look at the recent vote by a committee of the European Parliament asking the European Commission to perform a more drastic recast of the Medical Device Directives than might have been planned. The Parliament’s April 26 statement includes the request that the Commission impose a system featuring “more stringent checks and product traceability” as well as “a pre-market authorization system” more robust than that in place now.

The statement also notes that the PIP predicament “has shown a malfunctioning at European and national levels, notably a lack of cooperation . . . and a lack of traceability of raw material used for medical devices.” The statement asserts further that the widely reported problems with metal-on-metal hip implants has demonstrated “a failure of the current system of certification of compliance . . . as well as of the controls of the notified bodies and their surveillance by national competent authorities.”

One might also bear in mind the lack of reaction to something said by FDA’s Bram Zuckerman, MD, at CRT 2012. He claimed FDA drives most of the literature on cardiovascular devices, explaining that trials for devices “usually are done frankly because there is an FDA” demanding those trials. He also remarked, “I have a hard time finding CE-mark trials in publications of the first order.” Nobody dissented, and there were quite a few people in the room who were in a position to argue if they disagreed.

Gravitas is great; gravity is better

My working hypothesis on this is ably reflected by the notion of a binary star. If you picture FDA’s and the EU’s regulatory paradigms as two stars orbiting each other – one heavier and more stationary, the other lighter and anything but dominant – it’s difficult to avoid the conclusion that FDA is the more massive of the two, with the obvious implications. Prefer a more complex model that incorporates non-EU initiatives? Perhaps you’d find a depiction of a solar system more to your liking, but I’d point out that the most massive object is always at the center.

Of course the details matter, but let’s not be confused about the overall direction. FDA still outweighs everyone else, and will almost always have its way in a close call. If anyone is going to move anyone else out of their spot in the firmament, it’s not the European Commission, Health Canada, China’s State Food and Drug Administration or anyone else. It’s FDA.

When she tried to order her diabetic supplies, including insulin, a representative of the hospital told her she couldn’t possibly be diabetic because they didn’t have any record of her diabetes. I have experienced similar frustrations with the same military hospital because of my own unusual medical history.

It all comes down to the fact that military families move A LOT. When we move, we change doctors. Not only do we move, but our military doctors get transferred around a lot as well, so we end up seeing a dozen different doctors within a span of six months – no exaggeration. On top of that, we may have a chronic condition that requires us to see one or more specialists outside the military healthcare system. The result is inconsistent and very fragmented healthcare.

Fortunately, Humana Military Healthcare Services has recognized this problem and is trying to create a solution – in the form of a website for Tricare Prime beneficiaries (such as myself) to help manage our chronic care health information, even when we see a civilian doctor. When I learned about this website idea I nearly jumped up and did a jig.

While I don’t expect the MyActiveHealth website to end all of my military healthcare frustrations, I do think this is a huge step in the right direction. The idea is for the website to offer a secure way to store our health information and medical history so that we (hopefully) won’t have to deal with anyone telling us we don’t have a chronic disease simply because it’s not in their records.

The pandemonium was classic. Many marched up to management and demanded salary adjustments, using this poor naïve writer’s pay as a “negotiating” ground.

I wonder if something similar to this scenario will play out when the Physican Payment Sunshine Act will go into effect. I realize that med-tech said that it doesn’t mind the transparency, but are companies considering the kind of backlash this will have from paid consultants, who now have a sense of what their competitors are getting paid?

I really didn’t start thinking about this point until after I had a conversation with Michaeline Daboul president/CEO MMIS, a company that designs systems that enable organizations to manage and exchange data, earlier this month.

“When all this information gets published in a public online database and everybody from pro-publica to individuals start combing through this data, companies are going to have big PR nightmares,” Daboul said in an April 15th interview with Medical Device Daily. “They’re going to have customers who’re going to be upset with them. You’re going to have situations where you have customers that say, you didn’t tell me you were going to tell the world that you bring us lunch every week.”

While it might seem a bit simplistic, these kinds of issues can create a rift between med-tech firms and their clients, Daboul pointed out.

And I agree, whole-heartedly. It’s going to be interesting when this hits the fan. But I wonder, med-tech, are you truly ready for total transparency?

Not so much about how proven prevaricator Petrino finally lied his way into the ranks of the unemployed, although I did enjoy reading statements such as this classic from SI.com writer Michael Rosenberg: “The . . . university is shocked to discover that its lying-weasel football coach is a lying weasel.”

Rather, the extensive coverage of the circumstances of Petrino’s self-inflicted fall from grace led me to revisit a question that touches on truth-telling in the medical arena. It got me thinking about the reports I had seen a few weeks back on studies indicating that a considerable number of physicians regularly lie to their patients, apparently with few qualms about doing so.

Clearly the misadventures of Petrino serve as quite the metaphor for the inadvisability of being less than truthful. In the coach’s case, that left him with a well-documented reputation as someone not to be trusted, even though he had led the Arkansas program to considerable recent success.

So I went back and dug out some of the reports on the docs-lying-to-patients study originally reported on back in February. That study of U.S. physicians indicated that many among them lie to their patients and/or withhold information about medical mistakes, while also failing to disclose their financial relationships with medical companies.

The findings were reported in the February issue of the journal Health Affairs, and Dr. Lisa Iezzoni, professor of medicine at Harvard Medical School (Boston) and director of the Mongan Institute for Health Policy at Massachusetts General Hospital (Boston), who was the lead author of the article, said the results don’t bode well for healthcare that should be focused first on the needs of patients.

“It really is important for patients to have complete information about their prognoses if they’re going to make informed decisions,” Iezzoni said.

While the thought that there are some physicians who see little wrong with not being truthful with their patients or their caregivers as to the extent of their conditions is unsettling, I’m bothered even more by the cavalier attitude so many seem to have toward disclosure of financial relationships with drug and device companies. That type of thinking is downright disturbing, and should raise some interesting conflicts with new, highly specific disclosure laws due to take effect next year in the form of the Physician Payment Sunshine Act. For those docs who don’t get it, that’s “Sunshine,” as in shining light upon.

Another national survey released about the same time as the Mass General study found that nearly all orthopedic surgeons admitted practicing “defensive” medicine – the ordering of unnecessary tests, procedures and referrals – to avoid future liability. In the study, that was presented during the February annual meeting of the American Academy of Orthopaedic Surgeons (Rosemont, Illinois), some 96% of the more than 1,200 orthopedic surgeons who responded admitted ordering tests, procedures or hospital admissions primarily to avoid possible malpractice lawsuits.

The study shows that physicians “are clearly concerned about malpractice issues and they’re adjusting their practice procedures based on that fear,” said study lead author Manish Sethi, MD, co-director of the Vanderbilt Orthopaedic Institute Center for Health Policy (Nashville, Tennessee). Douglas Lundy, MD, chairman of the AAOS Medical Liability Committee, added that defensive medicine not only drives up the cost of patient care, but also “limits patient access to specialty care, neither of which is in the interest of our patients.”

So on the one hand we have physicians being less than truthful with their patients and on the other those in some specialty areas who simply opt not to provide care to higher-risk patients.

What’s a body to do? Well, I truly don’t have an answer for the “sorry, no care” crowd, but as for the lying weasels – oops, that was for Coach Petrino – my suggestion as a patient advocate, which is based on my own experience as a patient, is to emphasize to the docs with whom you have ongoing relationships that you’re interested in hearing the truth.

That should especially apply to your medical condition, but let him or her know that it also means you don’t want to be prescribed a drug or a procedure whose basis for use is the physician’s relationship with a company.

I liked a comment I read on this subject, uttered by Eric Campbell, PhD, research director at the aforementioned Mongen Institute and another co-author of the study: “I think patients need to be empowered to have very frank discussions with their doctors about the levels of truthfulness they expect from physicians and their healthcare team. It’s not unreasonable to begin a discussion with your doctor and say, ‘Look, I want you to be as honest as you possibly can. If an error occurred on my case, I would like to know about it.’”

Yes indeed.

(Jim Stommen, retired executive editor of Medical Device Daily, is a freelance writer focusing on healthcare issues.)

To wit: Dealing with FDA’s public affairs staff is typically not a bad experience unless they have to consult with others at the agency on fairly detailed matters. For instance, I’d written last year about a Federal Register notice addressing pre-emption of state law with regard to the physician labeling rule for drugs. The notice mentioned devices at several points as well as Riegel v. Medtronic, and I thought to myself, “in the absence of a physician labeling rule for devices, could this declaration affect liability for devices?” After all, FDA went way out of its way to discuss devices in the notice.

Several weeks and a number of e-mails later, all I had to show for my troubles was a promise from some unnamed individual that this did not affect device pre-emption via physician labels. It was clear that someone at FDA expected to handle the query by regurgitating the contents of the FR notice, and the agency’s public affairs staff got stuck with the dirty work of middleman. It was a lot of effort for nothing.

Warning letter faux pas

Recently, I called a diagnostics manufacturer about a December 2011 warning letter FDA had posted April 17, and the company told me that was the second appearance of the letter on the recent warning letters page, appearing there for the first time in January. When I contacted FDA, the first explanation was: “Apparently, it’s part of our web process. Letters are posted according to date on the letter as well as the posting date.” The e-mail also said there was “no compliance or other reason” for the reposted warning.

My response was: “The company states it had been posted at the beginning of the year and was reposted on the 17th.”

FDA’s response: “Yes. I think that’s correct. It’s part of the web process – not sure what the reason is but there is nothing more to it.”

Now I’ll acknowledge that I didn’t say “posted at the recent warning letters page at the beginning of the year,” but I’m pretty sure that’s how it was interpreted. After all, when does a warning letter show up in the archive without hitting the recent warning letters page first? Never. That’s how often. Trust me, I’ve been writing about warning letters for all but three years since 1999. I know the drill.

I questioned it further. The explanation I got was as follows:

The Warning Letter was posted on April 17 (Recently Posted List), and due to the letter being issued in 2011, it shows in two locations.

1. The Recently Posted List

2. 2011 listing of warning letters

On the next posting date (April 24) the warning letter will only show in the 2011 listing of warning letters.

The reason I find the agency’s responses unconvincing is that FDA’s practice has never been to post warning letters to the recent warning letters page more than once under any circumstances, and I’m pretty sure those letters never appear in the archive and the recent letters page simultaneously. If I’m wrong, FDA needs to say so.

A knowing deviation from standard practice or a boo-boo?

The company told me the first explanation they got from FDA staff was that the letter had been accidentally deleted from the archive and consequently had to be reposted to the recent warning letters page. That sounds a lot more plausible than any explanation I received from FDA. The CEO of this company also said they received a lot of calls from customers in January about the warning letter, and I find it hard to believe they got a lot of customer calls about the warning letter at that point in time if it had been posted only in the archive. That idea just does not pass the sniff test.

The best explanation I can come up with is that an overworked FDA employee screwed up and was playing CYA. This episode demonstrates why FDA needs a bigger budget, and I’ll say it again: Bully to the Alliance for a Stronger FDA, but Congress will do next to nothing – or worse – about significant increases in appropriations until they hear from voters. Any other understanding of that dynamic is dead wrong, and any efforts to meaningfully boost FDA’s appropriations that do not incorporate that understanding are doomed. Period.

“Take it back!”

“No, I won’t take it back, you stop bothering me!”

“I said . . . take it back!”

No, I didn’t hear this exchange at the playground in my neighborhood. Nor did this occur at the customer service counter of my local department store. But rather, this is the tone of a med-tech spat taking place in the “virtual” sandbox that has been taking place this week; one which has caught the attention of industry observers.

St. Jude Medical (St. Paul, Minnesota) is miffed about a recent paper published in the journal Heart Rhythm written by Robert Hauser, MD, and colleagues out of Minneapolis heart institute. The matter at hand involves study results from an analysis that assessed the number of death reports associated with St. Jude Medical Riata and Riata ST defibrillation leads compared with Medtronic (Minneapolis) Quattro Secure leads. This assessment was based on a search of the FDA Manufacturers and User Facility Device Experience (MAUDE) database.

On April 6, St. Jude issued a press release alleging numerous mistakes and oversights in the article, titled, “Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads” published online in Heart Rhythm linking the company’s Riata and Riata ST leads to 20 or more deaths. The company publicly asked the journal, which is published by the Heart Rhythm Society, to retract the article.

St. Jude went on the offensive and continued its assault on the Hauser article by posting a link to findings from the MAUDE database. The company contended that Hauser had grossly undercounted the number of deaths tied to Medtronic’s Quattro Secure lead, thereby making its own Riata leads appear far worse by comparison.

Medtronic, for its part, is saying its own review of an FDA database supports the controversial findings of the study tying St. Jude’s recalled Riata defibrillator leads with deaths from internal short circuits.

In the latest twist to the story, Douglas Zipes, the editor of Heart Rhythm, said the journal will not retract a controversial paper that has raised new safety concerns about St. Jude’s embattled Riata leads.

Zipes defended the publication’s process of expert review. “I understand industry’s pain, but I will not abrogate the rules and regulations that have served us so well,” Zipes said in the New York Times, referring to the peer review process. He said that Hauser had agreed to make some changes to his article before its print publication involving what he called “inflection” but added that “the bulk of the manuscript stays as is.”

No doubt this is concerning for St. Jude, given that these leads were once widely sold. The company removed the leads from market in late 2010 due to wires within the cables working their way through the insulation surrounding them. This would cause electrical problems, including shocks at inappropriate times. Then, a year later, the FDA issued a Class I recall on the leads, which caused some in the investment community to express concern on potential market share in 2012. St. Jude has since issued newer upgraded versions of the leads, which it claims are not affected by the same problem.

So . . . which side of the fence (or corner of the sandbox) do you fall on? St. Jude isn’t denying the deaths took place, it claims that the methodology was wrong and somewhat biased by Hauser. Speaking of whom, Hauser gave Medical Device Daily a “no comment” when reached Monday, and has only released a brief statement on cardiobrief.org claiming the authors “stand by the conclusion of our study.”

It’s not been a good April for St. Jude. Just last week, the company said it was having problems with its QuickSite and QuickFlex left ventricular leads used to connect cardiac resynchronization therapy (CRT) devices to the heart. The company reported that it has sent an advisory letter to doctors about visual observations of externalized conductors on the silicone end of the QuickSite and QuickFlex leads, however there have been no reports of patient injury or loss of therapy due to externalized conductors in these leads, the company noted.

As of Thursday night, April 12, there were no new developments in the saga, But, as always, we will keep readers updated as this drama continues and in and out of the sandbox.

So in the spirit of Prometheus and Epimetheus, the sibling Greek deities whose names translate respectively as forethought and afterthought, let’s examine the prospects for patents in this strange new world.

First, let’s ask Epimetheus about the Supreme Court decision in KSR v. Teleflex. The Court ruled in 2007 that any invention that would have occurred to a person “having ordinary skill in the art” is not patentable. Remember also that the doom-speak commenced immediately. For instance, law professor John Thomas of Georgetown University described the decision as “earth-shaking” during a session at the 2008 annual convention by the Advanced Medical Technology Association (AdvaMed), and Thomas was not alone in that assessment.

A lot has been written about the impact of KSR, but one thing strikes me as more telling than anything else. Had Thomas’s forecast proved out, one might have expected the backlog of patents at the Patent and Trademark Office to have ebbed noticeably as a result, but that didn’t happen. So how big a deal was it really?

This is not to imply that a Promethean view of Prometheus yields no cause for concern, but let’s not forget that Congress oversees PTO, not the nine black robes. Should patent chief David Kappos – who worked at IBM and hence has a profound appreciation for the economic importance of patents – decide he’s not interested in marching precisely to the letter of Justice Breyer’s dictum, what can the Supreme Court do? Not much. PTO is perfectly capable of subtly subverting and watering down the Court’s decision.

As for Myriad, there is nothing to prevent CAFC from registering essentially the same decision it offered previously, which was a 2-1 vote largely in support of Myriad’s patents for two breast cancer genes. If I’m not mistaken, CAFC more or less ignored the Supremes in Parker v. Flook, which has been widely cited as an important piece of the patent law landscape. So it’s not as if CAFC would be plowing virgin soil if it decided to ignore the implicit guidance for Myriad said to be found in Prometheus.

There is the possibility of a noticeable curtailment of patents due to Prometheus despite PTO’s leverage, but I’m pretty sure CAFC is not going to do something to annihilate life-science patents, partly because they may be unconvinced that the Supreme Court gets it about patents in the first place. I’d also point out that the judges at CAFC are less inclined than the denizens of the Supreme Court to indulge in airy abstraction and are much less cavalier about the centrality of patents to the economy and to the biotech century.

Obviously its easy for a member of the trade press to write breezily of such matters, and members of the patent bar would probably prefer that people like me leave such matters to people like them. Still, my advice is: Carry an umbrella if you must, but there’s no need to bolt for the nearest bomb shelter. The end of life science patents is not at hand.

When the news broke, Medical Device Daily, as well as other media outlets, picked up the story, and rightly so. Outside of regulatory issues with the FDA, the Medical Device Tax is the biggest concern that keeps device makers up at night.

Right now device makers are struggling to find a way they can pass the cost on. It’s going to be tricky – especially since many hospitals have more spending constraints and are being very conservative and cost conscious with their budgets.

The device makers have to look toward another approach and that’s going to be layoffs. Stryker did this late last year, pretty boldly when it said that it was cutting about 5% of its workforce or about 1,000 jobs. And most recently Hill Rom said that it would lay off about 3% of its workforce because of the med-device tax.

Analysts expect more of this sort of thing to happen which is why a lot of device makers have asked lawmakers to repeal the tax.

The only thing that’s different now, is that device makers no longer have to speak in the abstract about what could be harmful effects of the tax. Thanks to Medtronic’s announcement – those who oppose the tax now have a powerful tool to use in the argument against the measure.

You know the one I’m talking about: “If you’re happy and you know it, then your face will surely show it.”

It may not come as any great surprise that smiles aren’t adorning the faces of too many doctors these days, what with Medicare payment cuts, the looming impact of healthcare reform, skyrocketing malpractice premiums and other lesser complaints and concerns.

But all that notwithstanding, it was just short of astounding to read the results of a recent survey of more than 5,000 physicians by The Doctors Company, a Napa, California-based cooperative that is the nation’s largest medical malpractice insurer.

In response to questions probing the future of healthcare in America, nine out of 10 respondents indicated an unwillingness to recommend healthcare as a profession. I repeat: fully 90% of those respondents who are currently earning a living in the healthcare field said they would not recommend that field to someone looking to start a career.

Yikes! I mean, Mike Rowe of Dirty Jobs fame surely would come up with a better stick-with-it percentage than that, even if he were polling sewage workers or trash collectors.

And we’re not talking just “wouldn’t recommend it.” The physician respondents actually said they would “actively discourage friends and family members from pursuing careers in medicine.”

Perhaps not surprisingly given the level of hopelessness expressed, the Doctors Company survey also saw 43% of respondents – more than four of every 10 – say that they are contemplating retiring within the next five years.

Yikes again.

With some 32 million newly insured patients scheduled to enter the U.S. healthcare system by 2016 under various provisions of what goes by the shorthand tag of Obamacare, an already shorthanded cadre of healthcare professionals is anticipating even more strain on a stressed-out system.

The Doctors Company said the added insureds will increase the number of patients treated per physician, in turn exacerbated by an anticipated shortage of primary care physicians and nurses, “making it nearly impossible to maintain or improve the quality of patient outcomes.” And in the new world of healthcare coverage, patient outcomes are the coin of the realm.

“Sixty-five percent of respondents believe the current legislative initiatives designed to reduce healthcare expenses are insufficient to effectively address the underlying causes of costly defensive medicine,” the Doctors Company said. “Furthermore, the physicians surveyed expressed concern that the increase in patient volume will reduce the attention they are able to give to each patient, with 60% of respondents indicating that the pressures to increase patient volume will negatively impact the level of care they can provide. Fifty-one percent of respondents feel their ability to grow and maintain patient relationships will be adversely affected.”

In all, 60% of the respondents said healthcare reform will have a negative impact on patient care; 20% said the impact would be positive. As for the bottom line, 78% said Obamacare will negatively affect their earnings.

Richard Anderson, MD, chairman/CEO of The Doctors Company, said the response to the survey was “stunning.” While he noted that “we recognized that changes in healthcare delivery were impacting all facets of our members’ practice, the vehement, negative reactions are of real concern.”

He added that in reviewing the complete survey results, “the overarching sentiment is that current legislation will likely have a negative impact on the practice of medicine and will not address the scourge of defensive medicine in America.”

Expressing similar worries was Donald Palmisano, MD, a former president of the American Medical Association and a member of The Doctors Company board of governors. “The physician sentiments expressed in the Future of Health Care Survey are deeply concerning and disheartening,” he said.

Given the shortage of healthcare professionals, Palmisano said, “We are perilously close to a true crisis as newly insured Americans enter the healthcare system and our population continues to age. Unfortunately, we may be facing a shift from a ‘calling,’ which has been the hallmark for generations among physicians, that could threaten the next generation of healthcare professionals.”

Ironically, this negative reflection on healthcare as an occupation comes at a time when, according to the Association of American Medical Colleges, the number of applicants to medical schools is at an all-time high and numerous new medical schools are in various stages of development.

Maybe the survey just arrived on a particularly bad day.

(Jim Stommen, retired executive editor of Medical Device Daily, is a freelance writer focusing on healthcare issues.)

Perhaps the most credible criticism came from Tom Fogarty, a legendary entrepreneur in the medical device field. In a story written by Senior Staff Writer Amanda Pedersen, Fogarty asserted that “it’s reached a point in the field of medicine that we in the U.S. are no longer the leaders in medical technology.”

He noted that U.S. physicians go overseas to learn from physicians in other countries who have more experience with the latest technologies because they’ve had earlier access. “That is an upsetting situation, not just for our economy, but for our patients. It’s horrible.”

A story about a panel at the Southeastern Medical Device Association (Norcross, Georgia) annual meeting written by Staff Writer Omar Ford, noted that more companies are going to Europe and overseas to launch their products.

“One of the things we look for is predictability,” Robert Crutchfield, a partner at Harbert Venture Partners, said during the panel at SEMDA. “I think that’s one of the challenges with the U.S. market today. From my perspective, we don’t mind complexity as long as there is some predictability around the complexity, so you can jump through the hoops. So I think that Europe still has sort of a predictable process.”

Another panel member noted that thanks to the cultural change at FDA investing in medical device technology in the U.S. does not hold the appeal it did in the past.  “We think there are a lot of positive things about the medical device space primarily to bio-tech or pharma,” panelist Robert Morff partner with Hatteras Venture Partners, said. He noted that while it is still easier to get a product though clinical trials in the U.S., That’s “less true than it was a number of years ago and one of the issues in particular was that the medical device approval pathways are getting longer and they’re requiring more clinical studies.”

Several issues have helped to create this perfect storm for the U.S. med-tech industry. There is a great uncertainty in the FDA process and very little clarity on current healthcare reform efforts. Additionally, the industry will have to deal with the 2.5% Medical Device excise tax which is scheduled to begin in January 2013.

So what should be done to get the U.S. back on the right track to reclaiming its leadership position in medical technology? Fogarty said it will have to start with a cultural change on all sides – industry, FDA, CMS, and physicians.

“I think it’s reached a point that regulators and industry have become severe and fierce combatants,” he said. “We have to understand that we should be not competitive, but compatible. We must respect one another and once you establish that, then I think we can move forward.”

What do you think, is a lot of this talk just doom and gloom on the part of industry, or is there real trouble brewing for the medical technology industry in the U.S.?