FDA Priority Vouchers: Less Than Impressive

Some facts to chew on: The prescription drug industry is projected to reach $842 billion in global sales in 2010. Over the last ten years, 80 percent of the drugs that have entered the U.S. market are “me too” drugs that are no more effective than those we already use. Meanwhile, across the ocean, Sub-Saharan Africa accounts for 60 percent of the world’s 250-500 million malaria cases every year and 75 percent of the global population that goes blind from the infectious eye disease trachoma.  Both diseases can be treated through various drugs and antibiotics which pharmaceutical companies have the capacity to manufacture.

The billion-dollar question: how can we get drug companies to focus more of their formidable resources on producing drugs to combat these tropical diseases? The Food and Drug Administration (FDA) thinks it has the answer: a “priority voucher” program which grants drug companies accelerated approval for products targeted at wealthy countries as a reward for developing drugs that address tropical diseases. The program, established through a 2007 Congressional amendment to FDA legislation, essentially offers drug makers a deal: prove that you have, say, a new anti-malarial drug, and get your next blockbuster antidepressant fast-tracked for FDA approval. At first glance, this may seem like a sly bargaining chip to help the Third World; but in reality, the priority voucher program leaves much to be desired.

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Baucus Unveils Plan For Reform Over Three Years Part 2

While some argue that we must have health care reform “Now,” others (including HealthBeat) have argued that “doing it right” will take time.

In the white paper released today Senate Finance Committee chairman  Max Baucus seems to take both sides of the argument. On the one hand: “Congressional leaders and the public must be realistic about the timeframe in which the fiscal success of reform is measured. “

On the other hand:  “If we fail to act  we will double our current national expenditure on health care from $2 trillion to $4 trillion, continue to witness the plight of tens of millions of our citizens without health insurance cost shifting to those who do, continue to tolerate poor quality . . .  We must choose to invest now."

Is this simply political double-talk of the “Look Before You Leap”/“He Who Hesitates Is Lost” variety?

Not at all. Baucus’ multi-part plan would unroll over time “hopefully . . . in about three years.” (You can hear him offer this time-frame in his press conference on C-Span).  Over this period, he would create a Health Insurance Exchange that would insure that “affordable, high quality and meaningful health insurance options are available to all Americans.” The insurance offered through the exchange “would need to meet certain requirements established by a new Independent Health Coverage Council,” Baucus explains.

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Max Baucus’ White Paper on Reform: Courage, Honesty, Facts…It Will Take “At Least Three Years” (Part I)

Today, Senate Finance Chairman Max Baucus issued a “Call to Action” for Health Care Reform. And it is shockingly honest.

The bombshell in the plan is that it would require every American to purchase health insurance. There would be sliding subsidies for everyone under four times the Federal poverty level ($70,400 for a family of 3), but there would be no exemptions.

The individual mandate is necessary because Baucus is barring insurers from charging higher premiums or denying coverage outright to people with pre-existing conditions. (Today, in the vast majority of states, insurers can shun the sick–or charge them whatever it chooses).

As HealthBeat has explained here, if you insist that insurers must cover everyone, old or young, sick or healthy, at the same price, you must have the individual mandate. Otherwise, many young, healthy people would wait until they became sick to join a pool—safe in the knowledge that an insurer could not charge them more—and expect people who had been paying premiums into that program for years to now pick up their medical bills. If that happened, ultimately only the sick and the elderly would buy insurance—and prices would levitate to a point that virtually no one could afford it. 

What Baucus doesn’t mention is that community ratings are likely to hike premiums in many states because suddenly, the very sick will be included in the insurance pool. As Time magazine reported in 1994: In 1993, [when] New York State tried community ratings, “thirty- year-old males watched their premiums soar 170%, according to the Council for Affordable Health Insurance, while men aged 60 enjoyed a 45% cut. The rate hike for 30-year-old women was 82%, and women twice their age saw rates slashed by a quarter.”

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Advice for the “Seemingly Healthy”: Know Your Chances (Part I)

Here we go again.   If you haven’t yet heard the news from the American Heart Association meeting that was held in New Orleans yesterday, here is Bloomberg’s report on a medical breakthrough that, some say, will “change the way we practice medicine.”

Bloomberg, Nov. 9: “AstraZeneca Plc’s Crestor [a cholesterol-lowering medication] slashed the risk of heart attack, stroke and death by nearly half in people with normal or low cholesterol in a study, potentially opening a way to save the lives of thousands of seemingly healthy people.”

I like that last phrase: “seemingly healthy people.”  As we all know, there are no truly healthy people. Even if you think you might be healthy—you’re worried. You know there is probably something wrong with you.

Here, I can’t help but think of “The Last Well Person.” This was the title of an “Occasional Note” that Tennessee physician Clifton Meader wrote for The New England Journal of Medicine in 1994. His fiction was set in the not-too-distant future, and focuses on a 53-year-old professor of freshman algebra at a small college somewhere in the Midwest. He is…you guessed it, the very last healthy American.  Using advanced medical screening, physicians have found something wrong with everyone else. 

Now medical science is catching up with Meader’s science fiction.  It’s beginning to look as if all of should be taking Crestor, or some other cholesterol-lowering drug (a.k.a. a statin) even if we don’t have high cholesterol.

The trial of Crestor  reported at the AHA conference yesterday, showed the effect of the drug on patients who did not suffer from high levels of “bad” cholesterol—but did show high levels of a protein called CRP.  It turns out that CRP is a marker for inflammation. It is tied to heart risk even in “well” people with no additional symptoms. At the moment, Crestor is approved by U.S. regulators only to lower bad cholesterol. Now, it appears that it also reduces inflammation, and other statins may have the same effect.

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The Dangers of Do-It-Yourself DNA Testing

Recently, Time magazine listed the retail DNA test as its best invention of 2008 (thanks to Kevin M.D. for the tip). The best?  Maybe one of the most worrisome.

Time specifically highlights the do-it-yourself DNA testing kit from 23andMe, a California-based corporation named after the 23 pairs of chromosomes in each human cell.  The company sells $399 DNA kits that consist of a test tube in which you spit and send to the company’s lab. There, over the next 4-6 weeks, researchers extract DNA from your saliva and map your genome, putting the results online. You can access the results through the web and navigate a guide to your genes that estimates “[genetic] predisposition for more than 90 traits and conditions ranging from baldness to blindness.” 

Admittedly, this sounds pretty cool. As Time gushes, “in the past, only élite researchers had access to their genetic fingerprints, but now personal genotyping is available to anyone who orders the service online…” But look closer at the commoditization of DNA testing and the novelty wears off pretty quickly.

By pinpointing specific genes associated with certain diseases, a 23andMe gene read-out can inform a user of his or her susceptibility to those conditions. It turns out this is a lot less useful than it might seem. For example, Time reports that one test showed that the husband of 23andMe’s founder has a rare mutation that gives him an estimated 20 percent to 80 percent chance of getting Parkinson’s disease. The couple’s child, due later this year, has a 50 percent chance of inheriting this mutation, and thus his dad’s risk of Parkinson’s.

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The Bipartisan Merits of a Public Competitor

Long-term, Health Beat still expects that President-elect Barack Obama will reform healthcare. Originally (before the economic melt-down) he said that he hoped to roll out reform by the end of his first four years in office. Now, as Maggie indicated yesterday, he seems to be signaling that full-scale reform will have to wait until his second term. But there are steps that he can take to begin paving the way for reform in 2009.

For one, he needs to give Americans a chance to understand why a public sector health care plan, open to all Americas under 65 years of age, would be a good idea.  This plan would serve as a voluntary alternative to private insurance. People who didn’t want to enroll in the public plan could stick with their private insurer or move to one contracted with the National Health Insurance Exchange—the new government organization which, in addition to managing the public plan, would help to connect people with plans that adhere to certain government-specified regulations.

This so-called “public competitor” model, in which the government (a) introduces a new health care plan to compete with private insurers, and (b) tightens regulations on the health insurance market, has made its share of enemies on both the Left and the Right. Staunch single-payer advocates bristle at a reform package that still includes a role for private insurers, while conservatives view an expansion of the government’s role in health care as evidence of “socialism.”

Given the orthodoxies at work on both sides here—More government! Less government!—these complaints aren’t surprising. But both camps should understand that the National Health Insurance Exchange (NHIE) is a means of giving both single-payers and free-marketeers a health care system close to their cherished principles—without making health care reform an unnecessarily daunting and divisive endeavor.

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How Can You Help President Barack Obama?

On HealthBeat I have talked about social solidarity as the key to meaningful healthcare reform.

Last night, President-elect Obama sounded that theme repeatedly throughout his victory speech, reminding his audience that he had been elected “by young and old, rich and poor, Democrat and Republican, black, white, Hispanic, Asian, Native American, gay, straight, disabled and not disabled—Americans who sent a message to the world that we have never been just a collection of individuals…”

In the recent past, some progressives have warned that liberals made a mistake when they reached out to minorities, new immigrants, and gays, “ignoring” the mainstream middle class.  But in fact, “mainstream” America is no longer one recognizable culture. It is fast becoming a “magnificent mosaic,” the phrase Mario Cuomo used when he ran to become mayor of New York City in 1977. 

Barack Obama won, not because he managed to win over the white middle-class, or the white working class, but because he managed to put together a coalition from so many groups—including white voters.  Many thanks to Ezra Klein for breaking down the vote: 31.82 percent of voters who chose Obama were white, just as 31.57 percent of the voters who stood for John Kerry in 2004 were white.  But Obama won. What was the difference?

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The Truth about Spiraling Health Care Prices in the U.S., Part II

What is the biggest threat to the U.S. economy?

According to Congressional Budget Office Director Peter Orszag, it is not credit famine, the long-term price of energy, competition from China, the loss of jobs overseas, or even a surfeit of Chrysler SUVs.

It is, Orszag declared in October, “the nation’s looming fiscal gap — which is driven primarily by rising health care costs.”  Healthcare inflation cannot be ignored, Orszag added, because “If we fail to put the nation on a sounder fiscal course. . . we will ultimately reach a point where investors [will] lose confidence and no longer be as willing to purchase Treasury debt at anything but exorbitant interest rates.”

Today, investors outside the U.S. hold $2.74 trillion of Treasuries, or 52 percent of the $5.22 trillion in debt that the U.S. has issued. But now foreign buying of our Treasuries is falling. And, as Orszag has explained elsewhere, if we have to pay “exorbitant interest rates” to persuade foreign investors to  continue buying  our Treasuries, “over time, foreign investors would claim larger and larger shares of the nation’s output and fewer resources would be available for domestic consumption.”  Put simply, our standard of living would fall.

Why does Orszag single out soaring health care costs as the driving force behind our fiscal woes? Because healthcare spending accounts for over 16 percent of GDP, and it continues to grow faster than other sectors, outpacing both growth in GDP and workers’ wages. At $2.3 trillion a year and counting, our national health care bill is rising so fast that it threatens to crowd out other priorities—like spending on education, the environment, and infrastructure repair. Some in the health care industry point out that spending on medicine creates jobs, but as the cost of care levitates, we spend less in other sectors, and jobs in those areas disappear.

Moreover, unlike spending to repair bridges, strengthen schools, or protect the environment, Orszag suggests that the “excess” growth in health care spending is not adding to the wealth—or the health—of the nation. “The gains from higher spending are not clear” the Congressional Budget Office noted recently. “Substantial evidence exists that more expensive care does not always mean higher-quality care.”

Some observers took Orszag’s statement about the importance of health care spending as a signal that he was calling for universal coverage. He was not—not without simultaneously contain costs.

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Check Out Health Wonk Review

Be sure to check out the most recent Health Wonk Review, highlighting the best health care

posts of the past two weeks.  David Harlow, of the Health Care Law Blog is the host, and he has done a superb job of rounding up some very interesting posts, including:

Daniel Goldberg’ piece on Medical Humanities Blog explaining the McKeown thesis.  In brief, “McKeown suggests that medicine isn’t necessarily all it’s cracked up to be — 17th-to 20th-century improvements in population health measures likely had more to do with social and economic changes (e.g., improvements in the standard of living) than with public health and medicine (e.g., drugs and shiny objects).”

Joanne Kenen’s interview with, Geisinger CEO Glenn Steele on New Health Dialogue . Geisinger has been

making the “medical home” concept work, and other hospitals and policy experts are trying to figure out how to adapt the model.

Annie, blogging at Home of the Brave, “wondering why nurses and nursing aren’t a bigger part of the discussion on health care reform, given their work in the front lines.”

Louise, of Colorado Health Insurance Insider, who agrees with HealthBeat that advanced medical technology is helping to drive healthcare costs through the roof, but takes issue with my statement that Medicare should be using its clout to negotiate for lower prices. Louise points out that Medicare “has negotiated rates that are far lower than private health insurance reimbursement amounts on many treatments—including dialysis.”  Fair enough—but I’d still like to see Medicare doing what other governments do when it comes to negotiating for discounts with drug-makers, as well as device-makers.

Roy Poses, who castigates Ascension Health for its cut and run maneuver in Detroit at Health Care Renewal, (Ascension closed an inner city hospital while building a new suburban facility).

There are just a few highlights. For the full review, see http://healthblawg.typepad.com/healthblawg/2008/10/health-wonk-review-samhain-edition.html

Paging Dr. Mario

Over at The Health Care Blog, Douglas Goldstein wrote a post earlier this month on “health eGames,” a category of video games “that deliver measurable health benefits” to patients who play them. iConecto, a developer of such games, recently reported that there are already over 300  health eGames available—and that the size of this market over the next year will be $7 billion+. Consumers definitely seem open to the idea of healthy gaming: Wii Fit, Nintendo’s fitness video game, is poised to become the best selling title of the year, having already sold 8.7 million units.

This got me thinking: what about video games for doctors?

Kevin M.D. began to answer my question on Tuesday when he posted this YouTube clip on his blog:

This video simulates emergency room situations; surgeons can use it to train themselves in particular operations. This is a pretty cool idea: test the skills of a surgeon, but in a context where his slip-ups won’t cost lives.

What’s more surprising is that even conventional video games can play a role in training surgeons. In January, the BBC reported that a British hospital asked “eight trainee surgeons to spend an hour playing [non-medical video games] before performing ‘virtual reality’ surgery” through the program in the YouTube clip above. The hospital found that “game players scored nearly 50% higher on tool control and overall performance than other trainees.” The game that was most effective at improving their skills was Marble Mania, in which the player rolls a marble through a maze and obstacle course.

This isn’t all that weird when you consider how the technical skills you need for most video games—spatial awareness, fast reflexes, dexterity, and precision—are also vital to successful surgery. If a video game can help a surgeon brush up on these skills, it doesn’t matter whether it’s about a marble or a monkey.

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