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Daniel Kraft, MD on the Future of Medicine at TEDMED

Medicine today is “very much siloed,” observes Daniel Kraft, MD in a TEDMED presentation. Typically, a hospital has separate departments for oncology, ophthalmology, hematology, urology, neurology, and so forth. This departmentalized structure inhibits dissemination of information across disciplines. In addition, medicine is somewhat insulated from the rapid clip of technological change seen in the consumer space.

But medicine is undergoing a revolution. As new technologies that are coming out, we have the ability to redefine medicine, Kraft says, not just to make it more cross-disciplinary, but to make it more reliant on science. “[Now] we don’t really practice evidence-based medicine. We practice reimbursement-based medicine,” he says. 

Here's a video of Kraft explaining his vision of the medical feature at TEDMED 2011:

Brian Buntz

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Row Over Review Times Could Lead to Congressional Interference

FDA has missed a key deadline to submit reauthorization of user fees, due to continuing debates between industry and the agency, according to Bloomberg. If they miss the new Feburary 15 deadline, Congress, particularly those up for reelection, will be asking why. 

And its not the first time reauthorization has been delayed. Senators Thomas Harkin (D-IA), and Michael Enzi (R-WY), asked  FDA in July to submit a reauthorization plan by Dec. 31 so that the panel would have adequate time to review the plan.

Timing is sensitive because current negotiations are the first to occur during an election year, when Congress typically leaves Washington by the end of July.

Fred Upton is the chair of the House Committee on Energy and Commerce, and he is up for reelection this year. You can bet the committee will be watching the negotiations carefully. Upton is a top recipient of campaign donations from pharmaceuticals/ health products companies and medical device companies.

Upton and other Congressional leaders could take over the negotiations if FDA and industry can't get their act together. But even if they do agree on user fees, will it really help industry? Check out an editorial I wrote last year, explaining why MDUFMA III won't really solve review problems.

The Growing Reduction of FDA

To those who feel the increased presence of FDA investigators responding to commissioner Margaret Hamburg’s purported new emphasis on enforcement, and to those frustrated by slower 510(k) processing and more reviewer questions, that headline may seem hard to take seriously.
FDABut hidden beneath the increasingly dense opacity of the internal relationship between FDA and its parent Department of Health and Human Services (HHS), there has been a rarely seen reduction of the subordinate agency’s traditional autonomy and freedom to decide. 
No doubt a significant catalyst for this has been the ongoing controversy over the 510(k) program at CDRH, including most recently high-profile allegations of managerial incompetence and the Institute of Medicine recommendation that it be scrapped. The trend, however, long predates that report and has been so slow and incremental as to be unnoticeable outside of FDA. 

Examples of FDA's Internal Emasculation

The public got a startling glimpse of the agency’s internal emasculation in December when HHS secretary Kathleen Sebelius overrode FDA’s science-based decision to approve the “morning after” emergency contraceptive pill, Plan B One Step. Contrary to unbelievable public disavowals by President Obama, this was not Sebelius’ unguided independent decision. With a court-ordered deadline less than 24 hours away, she announced it immediately after traveling with Obama to and from Kansas aboard Air Force One. 
As George Neumayer in the American Spectator, among others, quickly observed, Sebelius has a long record of supporting FDA science. Her liberal attitude to abortion and contraception, not her unqualified, professed dissatisfaction with FDA science, ruled this decision. As Neumayer wrote, the politics was an Obama re-election strategy to remove an issue from the Republicans’ agenda. 
There is a lot more to this rare public glimpse of HHS dominance over FDA than has been revealed in this one episode.
FDA careerists have been chafing for many years under HHS’ steadily increasing and politically directed intrusions into their policy and decision-making. All of this is concealed from public view by internal institutional secrecy. The agency’s much-vaunted “transparency initiative” was never allowed to extend to such hidden management practices and political initiatives.
As one FDA commenter on my Web site complained, HHS has directed the reorganization of the FDA Office of Regulatory Affairs, taken senior executive service positions from FDA and assigned them elsewhere in its sprawling empire, restricted “necessary” FDA travel and restricted FDA actions against individual companies.
If true, this suggests a depth of HHS interference in internal FDA affairs that is unprecedented and shielded from public view. In bygone years, when such opacity could be readily broken by anonymous “deep throats” (think Watergate) and available news reporters, HHS never meddled in FDA’s arcane business. It also never publicly overruled a scientific FDA decision.

In any of the above alleged situations — HHS reorganizing the FDA Commissioner’s Office, or taking SES positions from the agency, or restricting FDA actions against companies, etc. — some enterprising news reporter on the scene would have heard about it from a credible, angry but nervous FDA source. The proverbial s— would have hit the fan. The fact that such never happened is highly suggestive of an HHS practice, long ago, of not meddling. 

A Formerly Hands Off Policy

As former secretary Joseph A. Califano was reputed to have told two FDA commissioners: “I don’t want to know what you are doing — just don’t let me get any nasty surprises in the Washington Post over breakfast!” This hands-off policy, intuitively and intelligently observed, served both sides well, and lasted through successive administrations until Bill Clinton ordered the approval of the abortion pill, RU-486, as he was leaving office, thereby setting a precedent for what happened on Plan B in both the Bush and Obama administrations. Institutional power grabbed is seldom later relinquished. 

As others have publicly observed since Sebelius’s precedent-setting power grab, FDA science ought not to be the stuff of politics. True, the FD&C Act speaks almost exclusively of “the secretary” as the repository of FDA’s authority to deliver scientific judgments. That is no excuse for upturning decades of commonsense delegation of real-world authority from the politicians to the scientist-regulators.

A Dangerous Precedent

And, as Reproductive Health Technologies president and CEO Kirsten Moore observed: “When we end up looking back on this ill-conceived decision, the worst consequence of all might well be that Secretary Sebelius established a dangerous precedent extending well beyond the future of Plan B One-Step or the next presidential election. When Sebelius overruled the reasoned and researched medical and scientific analysis, she cleared the path for future Department of Health and Human Services secretaries to do the same.” 
The implicit message to regulated industry in this situation—not invisible to FDA managers as well—is that when you don’t get what you want from FDA in any given regulatory disagreement, you’ll probably find receptive ears in the HHS secretary’s office where FDA’s actual authority resides.

Roaming bands of free-range reporters have been expelled from FDA’s hallways, presumptively for anti-terrorism security reasons.

In the short term, this may be a comforting and reinforcing backdrop for industry in its negotiations over product reviews and enforcement disputes. However, there is the obvious longer-term risk that the market value of FDA clearance and approval could be degraded in the broader scientific, medical and regulatory environment if HHS political domination of FDA decisions becomes, rightly or wrongly, the perceived norm.  
Roaming bands of free-range reporters have been expelled from FDA’s hallways, presumptively for anti-terrorism security reasons. As a result, rumors of hidden power grabs by HHS meddlers no longer may be confidentially heard and publicly pursued, and equally, the fear that they might be heard and publicly pursued is no longer a deterrent to their initiation. 
Although some would abhor greater FDA independence from political direction and redirection, relocating it outside of HHS and giving it a Federal Reserve-like independence from politics, as proposed by Harvard professor Daniel Carpenter in a New York Times op-ed, would seem a prudent solution to the creeping politicization that has tarnished its “gold standard” in recent times. And this might provide an opportunity to develop necessary, full transparency and accountability that could be a model for the rest of government.
Meanwhile, the growth of politicization across all federal agencies is recognized by some observers as a symptom of authoritarianism. It is defined in Wikipedia as “characterized by highly concentrated, and centralized power maintained by political repression and the exclusion of potential challengers. It uses political parties and mass organizations to mobilize people around the goals of the regime.” More details applicable to modern-day American governance abound on the Web.  

What Would Happen if Obama’s Healthcare Reform Were Repealed?

The Patient Protection and Affordable Care Act (ACA) has an unclear future. The Act’s insurance mandate provision remains controversial and it is possible that the Supreme Court will find it unconstitutional. If a GOP candidate is elected to the White House, the ACA legislation could face further challenges. It will be difficult, however, for legislation to be repealed altogether unless, Republicans win 60 additional Senate seats. Still, House Budget Committee Chairman Paul Ryan (R-WI) remains confident that the ACA will be repealed and he predicts that will happen in 2013.

clipboardBut even if that prediction comes true, it wouldn’t matter all that much in the long run. Healthcare reform, of some flavor or another, is coming and medical cost cutting is practically guaranteed. And to address that issue, there will need to be new strategies to find less expensive ways of treating patients that are the most expensive to treat. As an article in The Atlantic points out, 5% of Americans make up approximately 50% of U.S. healthcare spending.

And, for instance, electronic health records (EHRs), which Obama has strongly supported for its cost cutting potential, are expected to become more prevalent no matter what happens with the ACA. The majority of hospitals that lack EHRs plan to get them in the near term. And while EHRs have their detractors, many believe they could prove useful in improving patient care and reducing costs—at least in the long run. 

The cost savings made possible by the ACA are, perhaps, more debatable. Medicare actuary Richard Foster estimated last year that the legislation would triple the growth rate of net insurance costs. Meanwhile, the Congressional Budget Office predicted that repealing ACA would cost $210 billion between 2012 and 2021.

Everyone seems to agree that the main problem with U.S. healthcare, all along, has been directly related to costs—and the fact that healthcare is unaffordable to many in this country.

In its mission to improve healthcare in this country, however, the ACA calls for a number of new taxes and other funding sources. In essence, more than targeting cost cutting per se, it looks to reshuffle healthcare-related costs—reducing costs for some and raising them for others. To name but some of ACA's funding sources, the ACA legislation would boost the Medicare tax for the rich, will impose the much-discussed 2.3% device excise tax, create a sales tax on indoor tanning, a new tax for the so-called "Cadillac insurance policies," and create an annual fee on insurance providers. College students also would contribute by paying for interest on their student loans.

Saving Cash through Decentralization

5% of Americans make up approximately 50% of U.S. healthcare spending.

As Harvard business professor Clay Christensen points out, healthcare could be made more affordable through decentralization. And as the digital revolution continues, and telehealth begins to make good on its promises, this is bound to happen. As a result, patients will continue to become more empowered. Doctors can tap the power of technology to deal with a greater number of patients. And, with technological breakthroughs, physicians can be increasingly precise in the care they deliver. In addition, as consumers become more involved in their own healthcare, there is a lot of potential for change outside the healthcare delivery system. As Leslie Saxon has pointed out before, many people check their e-mail compusively. What if they were able to use technology to frequently monitor their vital signs and stress levels?

In terms of the broad trends, we've already seen decentralization at work in the computing industry. Decades ago, computers were rare—they were mainframes that required serious funding to afford. You had to be a specialist to use them. Now, practically everyone carries an impressive amount of computing power (that is relatively easy to use) with them in the form of a smart phone. And computing technology, while it isn't cheap, is always getting less expensive and more powerful. Now, computing power isn't centralized at all; it's pervaded practically every facet of our lives.

It's about time we harnessed the power of computing to help cut costs in healthcare, which, in many respects, is resistant to change. So what will this decentralization mean for an average patient? While he or she isn't ever going to be able to perform laparoscopic surgery with a cell phone, you could in the not too distant future, perhaps use a smart phone to diagnose an array of diseases and to help monitor a disease they already have. 

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Surgical Robots Based on Open-Source Platform Will Accelerate Robotics Research

Based on an open-source model, UCSC and the University of Washington are sending Raven II robots to several universities in order to accelerate research on surgical robots.

Researchers at UC Santa Cruz (UCSC) and the University of Washington (Seattle) have built seven surgical robots--dubbed Raven II--for their own use and for use by five other medical research laboratories, including Harvard University (Cambridge MA), Johns Hopkins University (Baltimore), University of Nebraska (Lincoln), UC Berkeley, and UCLA. The unique thing about these systems is that they are based on an open-source model in order to accelerate the field of robotic research. It is advantageous for the separate laboratories to work on a common platform because it will make it easier for researchers to share software, replicate experiments, and further collaboration.

Most research on surgical robotics in the United States has focused on developing new software for various commercially available robotic systems, according to Jacob Rosen, associate professor of computer engineering in the Baskin School of Engineering at UCSC and principal investigator on the project. "Academic researchers have had limited access to these proprietary systems. We are changing that by providing high-quality hardware developed within academia. Each lab will start with an identical, fully operational system, but they can change the hardware and software and share new developments and algorithms, while retaining intellectual property rights for their own innovations," Rosen adds.

Raven II includes two robotic arms, a camera for viewing the operational field, and a surgeon-interface system for operating the robot remotely. The system is capable of supporting research on advanced robotic surgery techniques, including online telesurgery.

Breast Implant Scandal Draws Cries for Stricter EU Regulation

Breast Implant Scandal Draws Cries for Stricter EU Regulation

Breast implant maker Poly Implants Prothèse (PIP) is continuing to make headlines in recent weeks after it was divulged that its implants, which are on the market in 65 countries, are more likely to rupture than comparable products. Roughly 300,000 women worldwide have received the implants from the manufacturer, which, because they are made of an industrial-grade silicone and not the medical-grade variety, are more prone to tear.  

This image of PIP's abandoned facility is from Flickr user Marcovdz. 

The development brings to mind CDRH director Jeffrey Shuren’s controversial comment last year that European patients were treated as “guinea pigs” for untested medical devices. That comment led to something of an outcry in defensive of the safety of the European regulatory system. 

But Shuren now might be thinking to himself "see, I told you so" to support the agency's recent track record of conservatism. Recently, Reuters pointed out that FDA warned PIP about the safety of the implants over a decade ago. The breast implant scandal has also triggered a number of editorials in prominent publications arguing for stricter EU regulation.

As a report on BBC explained, Lancet warned in a recent editorial by Richard Horton, MD that there may be a number of medical devices that are subject to fairly lax regulation, citing hip replacements, heart valve replacements, and implantable defibrillators. The issue of lax regulatory control in Europe “affects the entire device industry,” Horton said in the interview.

A piece in the Guardian explains that “many of those who opted for PIP implants, often on very limited incomes, presumably took that decision in the belief that the industry, much of which gives itself a pseudo-medical camouflage, is staffed by highly trained surgeons and GPs and is properly regulated and trustworthy.” It then goes on to state that “Thanks to the greed of Monsieur Jean-Claude Mas, PIP's founder, who now faces criminal charges around the world, today we know better.”  (An excerpt from a warning letter addressed to Mas can be found below the next paragraph.)

That’s quite a leap in logic—to cherry pick among one of the worst medical device scandals in recent history and claim that it reflects the behavior of the entire industry. Still, there is something of a negativity bias at work here, leading may people to remember scandals such as this one, ignoring the fact that medical technology, in the broad sense, has helped to improve the quality and duration of millions of people’s lives.

FDA sent Poly Implants Protheses a warning letter regarding the implants over a decade ago.  

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What Procedure Will John Edwards Undergo?

News came out that John Edwards has a serious heart condition, and needs to have surgery next month. According to The Washington Post, Federal Judge Catherine Eagles said Edwards " had “three episodes” and indicated his condition could be life-threatening if left untreated."

The condition has caused the judge to delay Edwards' trial for six counts of felony and misdemeanors. He is accused of concealing nearly $1 million from wealthy donors and using it to help hide his pregnant mistress during his 2008 White House run. This is the second time the trial has been delayed.

The court records state that Edwards must provide a written medical update by February 28.

So here is the breakdown for diagnosticians, based on what the newspapers say: 

  • Three episodes.
  • Advised not to drive or travel.
  • Taking medication.
  • Surgical procedure in one month.

So what procedure does he need and what devices would it entail. Cast your vote in the comments section and check back for updates.

photo credit: AP

—Heather Thompson

Report: Longer 510(k) Clearance Times a Result of a More Rigorous FDA

The average time it takes to obtain 510(k) clearance for a medical device has risen steadily in recent years, possibly as a result of FDA becoming more rigorous in its reviews, according to a report by Emergo Group. The firm, which provides QA/QC and regulatory consulting services to medical device companies, analyzed five years of FDA 510(k) data earlier this month and gave MD+DI an exclusive first look at its findings.

The average number of days from submission to clearance increased every year from 2006 to 2010, rising 40% to 135 days, over the five-year period. In 2006, two-thirds of 510(k) submissions received clearance within 90 days. By 2010, just 42% were cleared in three months or less.

Longer wait times, the report suggests, could be the result of the agency looking closer at submitted data and asking more questions during the review process.

“FDA is coming back with more questions during the submission process, and there is an increasing tendency to require more clinical data,” says Chris Schorre, vice president of global marketing at Emergo Group. “Those are not necessarily bad things. They slow down the process, but they do result in more rigorous submissions.”

Schorre says he’s optimistic the trend of increasing wait times for clearance will not continue. Industry has complained that if the process does not become more predictable, firms will increasingly seek initial clearance for products in Europe and other overseas markets. Over the past year FDA has also publicly acknowledged the problem.

“We’re hopeful that FDA will find ways to address it, whether by fixing its staffing issues or simplifying [the 510(k) process],” Schorre says.

In the meantime, FDA’s third party review program could be an option for companies—especially smaller ones—trying to get their devices to market quicker. The report found that, over the five-year span, clearance times took on average less than half as long when obtained through a third party review as opposed to an internal FDA review. In 2010, clearance times averaged 138 days for internal FDA reviews and 73 days for third party reviews.

Yet, fewer than 10% of devices go through the third party review process. Schorre suggests that could be due to three factors: lack of awareness of the program, especially on the part of foreign submitters; the fact that the process is not suited for complex or high-risk products; and its relatively high cost compared with internal FDA reviews.

“You pay for it, but for some companies, getting to market 70 days earlier is big deal,” Schorre says.

The report also showed that the number of 510(k) clearances has decreased in recent years. There were 3,327 products cleared by the process in 2006 but less than 3,000 in 2010, with the data reflecting two straight years of decline from 2008 to 2010. 

Analyzing clearance time by device type found that pathology, immunology, obstetrics and gynecology, toxicology, and hematology devices took the longest to clear, at an average of more than 160 days. Radiology products, by comparison, breezed through the process in an average of 72 days.

Other findings include:

  • Orthopedic, cardiovascular, general and plastic surgery, and radiology devices account for half of all products submitted for 510(k) clearance by FDA.
  • Almost three-quarters of 510(k) submitters opt for the traditional route, as opposed to a special or abbreviated submission.

The entire report, titled “An Analysis of FDA 510(k) Data from 2006 through 2010,” is available from Emergo Group.

Jamie Hartford

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Medical Device User Fee Act Reauthorization Hearing Scheduled

The Energy and Commerce health subcommittee has scheduled a hearing on the reauthorization of the Medical Device User Fee Act on February 15, reports Healthwatch, a healthcare blog maintained by the Hill. CDRH director Jeffrey Shuren will testify at the hearing. The user fee is set to expire on September 30.

Back in May 2011, MD+DI Editor in Chief Heather Thompson wrote about the merits and limitations that MDUFMA has brought to the medical device regulatory scheme. This might be a good time to (re)read her piece and find out why MDUFMA III won't really solve FDA's review problems.