Author Archives

John Irvine

Hacking Your Heart

Jun 23, 2011• 7

By ALEX EPSTEIN

implanted pacemaker xray

If they can hack your home computer, your mobile phone, apps, your store, your social networks, your bank account, your gaming system, your medical records, your school records, the government and its records, and pretty much anything anyone sets their mind to – isn’t it is only a matter of time until someone finds a way to hack your heart?

Not through a musical hook or melody that you can’t shake. Or a well timed smile by someone your soul connects with. Or a box of chocolates. Or a poem. People have been penetrating the human heart with those Luddite-ish tools since the beginning of civilization.

I was thinking more about that electronic device your doctor might have implanted into your chest to keep your heart beating. Or the little box stuck in your gut to help you and your pancreas regulate your diabetes. Or the mini-computer surgically inserted to keep your neurological systems on track.

Hacking the medical miracles put inside people to let them live longer with more normal lives.

While to my limited knowledge nobody has reported a single case and the likelihood is extremely low, it is a real enough concern that the New England Journal of Medicine published a paper about the need to improve security last year.

Twice Told Tale

Jun 23, 2011• 3

By PAUL LEVY

Back in 2008, Charlie Baker, then CEO of Harvard Pilgrim Health Care, and I, then head of a hospital, claimed that the market power displayed by the dominant provider system in the state and supported by the state’s largest insurer resulted in a large disparity in health care payments. We argued that this disparity contributed to unnecessarily high health care costs in the state. We both did this publicly, willing to put our assertions to the test. The quotes in response to this in a Boston Globe story were notable, but they did little to undercut our premises.

About a year later, the Attorney General of the Commonwealth published an investigation of this situation, which had the effect of validating our assertions.

Then, the largest insurer in the state said that the solution to the problem was to move towards a capitated, or global, payment regime. This would control the cost trend.

Again, knowledgeable observers, like the Inspector General, raised concerns. What if the global payment regime also created disparities and locked in higher rates? He noted, “[M]oving to an ACO global payment system, if not done properly, also has the potential to inflate health care costs dramatically.”

I pointed out that, while a global payment plan might have certain theoretical advantages, without a transparent exposition of its effects, how could we know if it had been successful?Continue reading…

FDA Should Add a Comparative Effectiveness Arm to Final Trials

Jun 17, 2011• 33

By MERRILL GOOZNER

The Food and Drug Administration’s Prescription Drug User Fee Act is up for reauthorization next year, and so is the consumer and drug industry face-off over the contentious issue of comparative effectiveness research (CER). Consumers, patients and some physicians are demanding that CER be required of all new drugs coming to market when there are already FDA-approved therapies for the same condition. They say it will give payers and patients immediate feedback on the relative worth of the latest drugs, which are always more pricey than what preceded them, especially if the older drugs are coming off patent.

Industry opposes including CER arms in final efficacy trials. The companies claim it will place additional costs on the already expensive new drug development process; provide inadequate information for actually divining the relative worth of two competing therapies; and dissuade companies from investing in follow-on drug research, which can turn up drugs that are significantly better than older drugs.

The American Enterprise Institute’s Scott Gottlieb, who served in the FDA during the Bush administration, this week offered a lengthy brief in support of the industry position. Unfortunately, he sets up a straw man in order to knock down what could be a very effective tool for lowering the cost of medicine. It behooves industry leaders to ignore his advice, and to ignore the bleating of their marketing departments’ incessant demand for follow-on drugs.

Is TV Killing Us?

Jun 16, 2011

By MERRILL GOOZNER

The latest Journal of the American Medical Association has a meta-analysis of the limited number (8) of studies that looked at peoples’ television habits and their relationship to incidence of diabetes, heart disease and early death. According to Anders Grøntved of the University of Southern Denmark and Frank B. Hu of Harvard Medical School, two hours of television viewing per day resulted in a 20 percent increase in type 2 diabetes, a 15 percent increase in heart disease, and a 13 percent increase in all-cause mortality. All the findings were statistically significant. In absolute terms, for every 100,000 people who viewed TV for at least two hours a day, there were an additional 176 cases of type 2 diabetes, 38 cases of fatal cardiovascular disease, and 104 deaths of any type.

Is this really a smoking gun? Correlation is not causation. What else do we know about people who watch at least two hours of TV a day? Are they depressed? Are they bored? Is their sedentary lifestyle a product of some underlying condition, which may actually be the proximate cause of the diseased state?

As the authors note in their discussion:

Although the included studies attempted to control for various known risk factors, the possibility of residual or unmeasured confounding cannot be ruled out. . . Although all of the included studies excluded participants with chronic disease at baseline, it is still possible that reverse causality may contribute to some of the associations reported herein if participants with subclinical stages of disease become more sedentary.

Karen Goozner, a certified school counselor, recently surveyed the literature that associated violent childhood behavior with watching violence on TV. The literature suggested it was a co-factor, not a causative factor. she said. In other words, families with a history of violence – who believed physicial violence was an appropriate response to social or child-rearing problems and role-modeled that behavior for their children — tended to also watch violent television for entertainment. Did the TV do it? Or was it mom or dad?

Television can be blamed for many things. Bad writing. Bad acting. But let’s not blame the escape valve for the pressures of modern life and worklife that has driven western Europeans (3.5 hours a day average); Australians (4 hours a day average) and Americans (5 hours a day average) to seek refuge in the depressing, all-night escape of drinking in front of the tube.

Another Legal Round – With a Major Misstep?

Jun 16, 2011• 10

By ROGER COLLIER

The appellate court hearing in Atlanta a week ago on the Affordable Care Act’s constitutionality, one of a series along the inevitable road to the Supreme Court, showed that the opposing legal arguments are beginning to be firmly established—with each seeming to confuse the purchase of health insurance with the purchase of health care.

The Atlanta panel of three judges, with both Republican and Democratic appointees, heard arguments for and against the earlier ruling by Judge Roger Vinson in Pensacola that the individual mandate was unconstitutional and so central to the ACA that the entire act should be invalidated, and specifically that while the Commerce Clause of the Constitution gave the government authority to regulate interstate commerce, it did not allow Congress to penalize people for the “inactivity” of declining to buy a commercial product.

Former Bush administration Solicitor General Paul Clement, arguing in support of the Vinson decision, agreed that while it could be permissible for Congress to require insurance or other payment by those being treated in an emergency room, because they would already be in the “stream of commerce,” it was a very different matter to require them to pay prospectively for future care.

Obama-ney Care

Jun 15, 2011• 3

By SENATOR DAVID DURENBERGER

Tim Pawlenty used a recent appearance on Fox News Sunday to show a tougher demeanor and to prove he will not make health care cost containment and access a priority. As Governor of Massachusetts Mitt Romney worked with the Democratic legislature and the health care industry to expand access to all residents of the state and to commit to cost containing behavior change. The coverage reforms came right out of conservative health policy playbooks at Wharton (in the 1980s) and the Heritage Foundation (in the 1990s) and the cost containment was to be accomplished by voluntary action of Massachusetts health systems and health plans. On which they have since foundered, leaving Romney to take the heat.

When President Obama made his commitment to reform of national coverage, access, insurance, payment, and delivery system policy, national Republicans refused to cooperate. The legislative policy approach he advocated came mostly from a bipartisan Senate Finance Committee report from 2008. Elements of it came from the bipartisan approach Romney took in Massachusetts. Congressional Republicans unanimously refused to participate in the process. Today every elected Republican has committed to repealing Obamacare (and now Obama-ney care).

What changed? The definition of Republican. The election power of Sarah Palin, Michele Bachmann, Jim DeMint and the Rupert Murdoch/WSJ/Fox version of facts to bring out the “just vote No on government and on Obama” in a substantial enough minority of Americans turned the trick. While Pawlenty and Bachmann represent a state which has been committed to universal coverage and healthcare cost containment for decades, neither has done much to make it a reality in our state. Assuming “repeal and replace” implies state action is preferable to national, they’ve nothing to show for their efforts so far.

Senator David Durenberger, Minnesota, served in the US Senate from 1978 – 1995.

The Stunning Shift Toward Employed Physicians

Jun 14, 2011• 85

By DAVID E. WILLIAMS

I’m amazed at just how quickly physician employment has swung from small independent practices to hospital-based employment. I’ve heard about it anecdotally from medical societies and malpractice carriers who are seeing their constituents shift, and have certainly observed the shift from individual physicians, but I’m still surprised how fast it’s occurring. A new report from recruiter Merritt Hawkins tells the clearest story I’ve seen:

In the last 12 months, 56% of physician search assignments have been for hospital jobs, whereas 5 years ago it was just 23%
Just 2% of assignments were for independent, solo practice docs compared with 17% 5 years ago

Doctors are becoming more like regular wage earners, albeit high paid ones. There are some strong drivers of this trend including the need to support health information technology, comply with regulations and deal with health plans. There’s also a desire on the part of a younger, increasingly female physician workforce to have a better balance between work and home life. If anything the forces pulling physicians into hospital employment will strengthen in the near term with the arrival of Accountable Care Organizations and other forms of deep integration.

Yet when a pendulum swings it tends to swing too far. Especially considering how quickly things have moved, I do expect that there will be some backlash to the rush into employment. It’s really not all that much fun having a boss, especially when that boss is a big, bureaucratic hospital with other things on its priority list besides MD satisfaction and career development. Patients may not like it so much either. I know I’d rather see a physician who’s not too tightly tied to a hospital.

So what will the reversal look like? I don’t think it’s going to be doctors rushing to put up their own shingles or buy practices of retiring docs like in the old days. Instead I expect to see a new breed of physician employers who recognize what’s needed to make docs happy, treat patients well, manage compliance, and still make money. One example is so-called direct primary care practices such as Qliance. Time will tell what other forms develop.

It’s THCB’s Health Wonk Review

Jun 9, 2011• 1

By Matthew Holt

It’s Thursday morning. Fresh off the digital presses. It’s finally here. THCB (after a long absence) is back hosting Health Wonk Review….

Health IT Dept

We start close to home with huge news for THCB’s sister organization Health 2.0. (FD-Matthew Holt THCB’s Founder is also Co-Chairman at Health 2.0). And the news is that the world has gone crazy for Challenges, and that HHS and ONC (they of the billions for EMRs) are joining in, and funding a huge series of challenges for tech innovation in health care. Over at Health 2.0 News Matthew and Health 2.0 CEO Indu Subaiya explain Heath 2.0’s role in Investing In Innovation or i2.

And if that wasn’t enough, the entire health data wonk world is descending physically or virtually on Rockville, MD this morning for the Data-Palooza inspired by HHS’ CTO Todd Park. If you don’t know about Todd you should read this great profile by Simon Owens in The Atlantic. But THCB published Todd’s piece about the Data-Palooza (or more formally the Health Data Initiative Forum) a fraction ahead of the HHS blog, so we’re linking to it here. It includes information about what, who and how you can see it live–and if you care about health and tech and data, how can you miss it?

Of course, i2 and HDI is not all that’s been announced in tech this week. Inspired by Steve Jobs’ iCloud keynote this week in San Francisco, Dr. Jaan Sidorov at the Disease Management Care Blog ponders the healthcare potential of Apple’s ballyhooed mobile operating system.

Despite the boom over the past few years in new technologies and services targeting healthcare, many new services are not doing as well as the experts have predicted. (Note LOTS more HWR below the jump)

An Obama-Gingrich-Ryan Ticket on Health Policy Reform

Jun 3, 2011• 2

By SENATOR DAVID DURENBERGER

Newt Gingrich has to be one of the most interesting figures in recent political history. His soul lives at the intersection of public policy, politics and history. Because he has been on so many sides of history and policy, political insiders greet his entry into the presidential primary campaign as “Harold Stassen-ish.” I am among them, having entered the Senate the same time Newt entered the House 30-plus years ago. I don’t know Republican House Budget Committee chair Paul Ryan, but I admire his leadership talent and regret his decision not to run for the Senate from Wisconsin. It would raise the level of health policy discourse substantially in that “august body.”

Barack Obama is undoubtedly making presidential history. Given the many policy challenges he has had to take on since January 20, 2009, plus the one he chose to take on – health policy reform, aka PPACA, there’s no question he is in a unique place in history today. But, it is the Republicans – the “Party of No” on Obamacare – that are carrying the day on bringing health policy in line with health reform on the ground in the U.S. today. Obama’s PPACA sets historic national policy goals. Ryan and Gingrich articulate the policy means to the ends of the new law.

Public health insurance programs like Medicare and Medicaid should begin now to reward success in meeting access, quality, and value goals where they exist in communities and systems across the country. On their way to converting to private insurance and “premium support” subsidies when, and only if, genuine competition comes to the insurance marketplace. Along with the information consumers of insurance and healthcare need to make value judgments to purchase.

Obama could encourage this now because he has the new law on his side. He has a budget/debt ceiling impasse which could make it possible. Unfortunately, he doesn’t know it; and it appears those in his administration charged with implementing PPACA, haven’t figured out how to do it. Bogging down in waivers and new rules and regulations which set the new law up for “socialistic” ridicule, and the president for a messy political campaign which will not, as Gingrich suggests, “lead to a national discourse” on the future of health care policy and politics.Continue reading…

What Dr. Oz Learned From His Cancer Scare

Jun 3, 2011• 16

By DAVIS LIU, MD

Dr. Mehmet Oz recently had a piece in Time titled “What I Learned from My Cancer Scare” in which he became the more humbled Mr. Mehmet Oz. As noted previously here, Dr. Oz last summer had a colonoscopy at age 50 and much to everyone’s surprise had a precancerous colon polyp. He was advised to follow-up again for a repeat test in 3 months.

As the Time magazine piece noted, he didn’t return for 9 months despite repeated reminders from his doctor.

From this experience, he essentially stumbled upon what has been challenging American medicine and primary care. How do we enable patients to do the right thing and get the screening tests done and treatments necessary to avoid premature death and maintain a high quality of life? As a highly trained professional, Dr. Oz knows the risks and benefits of not doing a preventive screening test. As a doctor, he knows all of the secret protocols and codespeak we use when calling patients or asking them to see us in the office for important matters. As a doctor, he also understood the importance of a repeat colonoscopy to ensure no more colon growths.

Yet he didn’t return for 9 months. Why?

None of us want to deal with our mortality. Having a screening test means there is a possibility that the test may be abnormal and now we must confront it face to face. Skipping the test means to be blissfully ignorant, even if it is the wrong thing to do.

Also, as Dr. Oz noted, many individuals, particularly those who are otherwise healthy with no family history, feel that many of these tests or interventions don’t apply to them. Trust me, I know. As a practicing primary care doctor, do you know how hard it is to convince someone to get screened for colon cancer? Get vaccinated for pertussis, influenza, or pneumonia?