Last week the Supreme Court ruled that medical device-makers are protected from personal injury lawsuits so long as their products have passed the most stringent FDA approval process. The principle that the Justices cited in their decision was “preemption”—the idea that the FDA stamp of approval is final, binding, and supersedes any problems or malfunctions that may subsequently occur.  This means, more or less, that if your pacemaker blows up the device-maker can shrug and say “sorry buddy, the FDA gave it the okay; you’re on your own.”

As harsh as this may sound, there is an argument to be made for preemption. The principle was pretty clearly written into a 1976 medical device law and the pro-business contingent has a point when it says that without some degree of preemption, competition is nigh impossible (it’s tough to navigate 50 different state codes, and the companies that can are the big, established ones).

But regardless of the principles behind the Court’s decision, the practical dimensions of the ruling leave much to be desired. Preemption only has teeth if the FDA does—but the agency is all gums.

For years, the FDA has been in a state of steady decline. According to a former FDA chief counsel, the agency’s staff has shrunk 14 percent over the last 14 years. Experts say the FDA needs a 15 percent boost in funding per year for the next five years in order to be effective, and a November report revealed that the FDA barely has any computers or personnel infrastructure.

In short, the FDA is a mess, and the entropy hasn’t spared medical device regulation. To help fill its empty coffers, since 2002 the FDA has had a system in place that allows device-makers to pay fees in order to expedite product inspections. It is estimated that between 2007 and 2012, the FDA will collect $287 million in fees from medical device companies—just over a fifth of the total cost to the FDA to review new devices.

Continue reading →

Today the Wall Street Journal ran an editorial urging the FDA to approve Avastin, a drug used to help treat colorectal cancer, for breast cancer. It’s an angry—and ultimately, wrong-headed—piece.

In December, an FDA advisory committee voted against allowing Avastin for breast cancer treatment; the FDA is expected to make a final decision this weekend that either affirms or rejects the committee’s recommendations. The Journal supports a rejection the committee (and approving the drug) because “in clinical trials, Avastin demonstrated the longest reported ‘progression-free survival’ for patients with advanced breast cancer.” In other words, patients “live longer before their disease spreads or worsens” when they take the drug. So, says the WSJ, the FDA has a moral obligation to approve Avastin, because it “translates into an improvement in quality of life by delaying the onset of symptoms.”

But in reality the situation isn’t nearly this simple—and for all its good intentions, the Wall Street Journal trips over its own logic.

Clinical trials show that Avastin plus paclitaxel (the scientific name for the brand drug Taxol) helped to keep cancer from growing for five months longer than in patients on paclitaxel alone—this much is true. But there’s more: as an American Cancer Society summary of the original December decision notes, “overall survival was not significantly better [for those who took Avastin] and women who received Avastin had more serious side effects compared to those who got paclitaxel alone.”

The Journal is quick to note that “not significantly better” refers to the fact that women on Avastin “lived slightly longer, a median of 26.5 months compared with 24.8 with Taxol alone.” That means that, even though cancer was slowed for five months, the average lifespan of an Avastin-taker was ultimately only lived two-months longer than it was for those who didn’t take the drug. The newspaper is angry that the FDA trivializes this time be deeming it a statistically insignificant extension. But there are other things to consider besides time—like side-effects.

Continue reading →

Government gets a bad rap in American politics. Not all of it is undeserved, mind you, but one thing that isn’t deserved is the accusation that the public sector is unable to innovate. In fact, for some of the innovations that matter the most—like electronic medical records—the public sector might just be our best bet for progress.

Consider the example brought up by Jack E. Lohman, a Health Beat reader who comments on Wisconsin politics. Responding to one of my posts, Lohman offered information about VistA, the Veteran Administration’s electronic health records system. Lohman notes that VistA works by “instantaneously search[ing] for patients around the country with similar diseases and lists the physicians’ treatments and successes, grouped by the most common treatments.” In other words, it aggregates and cross-compares data to see which treatments have worked for which kinds of patients.

This information is then matched up with “a one-time, lengthy health questionnaire that would be turned over to the physician for evaluation.” Translation: patients are surveyed to see where they fit in the VistA database so that doctors can better assess their situation. (This might sound familiar: it’s similar to Germany’s system of “diagnosis-related grouping,” which I mentioned in a post last month).

VistA is a great tool—and, I would argue, one that exemplifies the benefits of getting the public sector involved in health care IT.

Continue reading →

After the stock market bubble burst, the New York Times asked: “Where were the analysts? Why didn’t they warn us?”

To be perfectly honest, this was a somewhat disingenuous question. As experienced financial journalists understood all too well, the analysts plugging the high-flying issues of the 1990s were employed by Wall Street firms raking in billions as investors bet their nest eggs on one hot stock after another. It really wasn’t in their employers’ interest for analysts to tell us that their products were wildly over-priced.  When a small investor wades into the financial world, there are two words he needs to keep in mind: “caveat emptor.”

But physicians, I firmly believe, are different from the folks employed by Merrill Lynch. (I don’t mean to knock people who work at ML. I am simply saying that they have a very different job description.)  When consulting with your doctor, you should not have to be wary. You are not a customer; you are a patient. And your physician is a professional who has pledged to put your interests ahead of his or her own.

This brings me to the question I ask in my headline: during the many years of the Cholesterol Con—where were the doctors?  When everyone from the makers of Mazola Corn Oil to the Popes of Cardiology assured us that virtually anyone could ward off heart disease by lowering their cholesterol, why didn’t  more of our doctors raise an eyebrow and warn us : “Actually, that’s not what the research shows” ?

No doubt, you’ve heard about the recent Business Week cover story, “Do Cholesterol Drugs Do Any Good?", which blew the lid off the theory that “statins”– drugs like Lipitor, Crestor, Mevacor, Zocor and Pravachol — can cut the odds that you will die of a heart attack by slowing the production of cholesterol in your  body and increasing the liver’s ability to remove L.D.L., or “bad cholesterol,” from your blood.   

It’s true that these drugs can help some people—but not nearly as many as we have been told. Moreover, and this is the kicker, we don’t have any clear evidence that they work by lowering cholesterol.

Although medical research suggests that statins can definitely benefit one group—men under 70 who already have had a heart attack–researchers are no longer convinced that the drugs stave off a second attack by lowering the patient’s cholesterol. The drugs do lower cholesterol, but that is not what helps the patient.

Continue reading →

In December I wrote about a government effort to block  the use of checklists in ICU’s.

Yesterday, I received an e-mail from Robert M. Wachter, MD, Professor and Chief of the Division of Hospital Medicine UCSF Medical Center, headlined: "a happy ending to the checklist story (thanks for your help)

Wachter sent this link to a story on his website which explains that "The Office for Human Research Protections (OHRP) – part of the U.S. Department of Health and Human Services – has concluded that Michigan hospitals can continue implementing a checklist to reduce the rate of catheter-related infections in intensive care unit settings (ICUs) without falling under regulations governing human subjects research."

Wachter commented "I must admit, I didn’t hold out high hopes that a ragtag band of committed clinicians and other quality improvers could change federal policy. But we’ve done just that. If the Feds are capable of rectifying this mistake, who knows what might be next!

Indeed.

Over at American Prospect, Ezra Klein offers a sharp, well-reasoned critique of our for-profit insurance system.

First, he points out that when insurers offer us many choices – catastrophic plans, high-deductible plans, consumer-driven plans with high co-pays –what they are really doing is “turning their attention to making deals with the most profitable among us, and avoiding deals, or finding ways to break contracts, with the least profitable. They are very innovative in their attempts to do this. But there’s nothing good about those attempts. Competition among drug dealers does not aid the neighborhood, and currently, competition among insurers does not aid the ill.”

In fact, Ezra stresses: “It is actually counterproductive for insurers to compete on giving us the best care. It’s not simply that they’re not doing it, but given the structure of the marketplace, they shouldn’t do it. Imagine insurer X creates the best damn diabetes protocols in the country. And they begin advertising this fact. What happens on Day Two? Well, they’re flooded with individuals suffering from diabetes, or individuals who fear they will one day be suffering from diabetes. These people, in the current system, are a bad deal. Not only is it near impossible to insure them at a profit, but pooling their costs (which is what insurers do, after all) raises premiums for all the insurer’s other customers . . .”

This explains why insurers so rarely compete on quality. Most often, they compete on price. And watch out when they do that. This is a market where you get what you pay for, and a less expensive policy is likely to be filled with holes that will open, like trap doors, when you become sick.

Is there any way that we could force private sector insurers to add value to our health care system?

Klein offers Tyler Cowen’s prescription for how, “in a more perfect world,” insurers might compete to offer better service, not just cheaper coverage.  But they would have to be tightly regulated.

Check out Klein’s full post here. It will also link you to Cowen’s argument.

On this blog, we have often debated these questions: “Why is U.S. healthcare so expensive? Why is it that states like Massachusetts and California just can’t seem to find a way to provide high quality, affordable medical care for all of their citizens?”

In the past, I have suggested that the answer can be found in the work done by Dr. Jack Wennberg and his colleagues at the Dartmouth Medical School. The story that I have posted below provides the narrative behind that assertion, tracing how, over a period of thirty years, Wennberg and his team uncovered the incredible, incontrovertible waste in our health care system.

Wennberg’s work reveals that roughly one out of three of our health care dollars is squandered on unnecessary tests, ineffective, unproven, sometimes unwanted procedures and over-priced bleeding-edge drugs and devices that are no better than the less expensive products that they have replaced.

Only a Luddite would fail to appreciate the wonders of 21st century medical technology. And Wennberg is no Luddite. He is quick to acknowledge that the most expensive, aggressive care that U.S. doctors and hospitals provide is often the most effective care.

But not always. This is what is less obvious. It would seem that by spending so much more than other countries, we would be buying the best care on earth. But the evidence shows that, often, we are not. And therein lies the conflict at the heart of our money-driven health-care system: while more health care equals more profits, it does not necessarily lead to better health.

The story below, which I wrote for the winter issue of Dartmouth Medicine, will, I think, give readers a much clearer understanding of the importance of the Dartmouth research. It begins in the early 1970s, when Wennberg realized that if his home were located just 100 yards farther north, his children would be in a school district where 70 percent of all children received tonsillectomies. Instead, they lived in a school district where there was only a 20 percent chance that they would undergo the operation.

Continue reading →

As some readers may have noted, a recent post of mine discussing some of my concerns about virtual medicine has been met with some hostility—mostly (but not in all cases) reasoned, intelligent hostility– but dislike nonetheless. That’s fine, but here’s the issue: what’s being framed as a litany of inaccuracies is really just a difference of opinion.

First thing’s first: there is one hard fact on which I misspoke. Companies that facilitate online doctor-patient conversations like Medem, Inc. and RelayHealth have been around for close to a decade. I erroneously referred to them as new. For that, I apologize.

But here’s the thing: my post wasn’t about these companies, and even less about their age. I was writing about some concerns I have over virtual consultation—primarily, how much of the hubbub over virtual medicine will really translate into addressing what I feel are our most pressing health priorities.

Some people took offense. A comment from Matthew Holt, editor of The Health Care Blog, suggested I was “slagging off technologies that have some slight promise”—a sentiment he repeated on the front page of his blog. This is an overstatement. In my post, I made perfectly clear that I understand the excitement about online consultation and would most even likely use it myself. My reservations come from the Internet-as-messiah mindset.

One concern is with access—web medicine seems like another innovation that will benefit the “haves “more than the “have-nots” in part because poor Americans have less access to the Internet. Matthew counters my worries about the digital divide by saying that Internet penetration might be uneven in homes, but it is very high in schools, libraries, and workplaces. This is true, and it’s this sort of broader definition of Internet access that informs statistics celebrating America’s near-universal web presence.

Continue reading →

One of the most common justifications for consumer-driven medicine is reduced health care costs. The reasoning here is two-fold:

1. Since they’re high-deductible and low premium, consumer-driven health plans require more out-of-pocket spending. Consumers are more cost-conscious when they have to actively shell out for purchases. As a result, they will user fewer health care services—and thus overall health care costs will fall.
2. If consumers are in the driver’s seat, competition in an open market will drive prices down. For-profit providers will want to offer the best deal to get the most business. Consumers will also have better information thanks to the commoditization of medicine, which will translate medical jargon into universally comprehensible knowledge. Smarter consumers translate into less over-payment for services.

This is standard-issue free market orthodoxy at its finest. Unfortunately, this isn’t the whole story. In fact, there’s an even stronger argument to be made that consumer-driven health plans could lead to higher health care costs.

The Wrong Patients Forgo the Wrong Care

Research by the RAND Corporation’s health insurance experiment shows that when you shift costs to the consumer, patients forego both wasteful and effective care. And this is particularly true of the patients who cost us most in the long run—those suffering from chronic diseases.

A 2007 paper from the National Bureau of Economic Research looked at retired California public employees on Medicare, and its findings contradict some of the basic assumption of the consumerist movement.

The study’s authors–from Harvard, MIT, and the University of Oregon– found that chronically patients who are asked to shoulder more of their health care costs deferred, neglected, or opted-out of doctor’s visits and drugs when the price got too high. This short-term cost reduction led to long-term catastrophe, as their hospitalization rates were significantly higher than other patients suffering from chronic diseases. Immediate savings ultimately led to a greater—and otherwise preventable—use of more expensive care. Oops.

This makes a certain amount of sense. Chronic diseases are not always in-your-face. They often simply simmer. But if the disease isn’t managed, ultimately it explodes. Until that happens, it’s easy to ignore the problem, especially in a context of consumerism that places an emphasis on convenience above all else.

Continue reading →

The Center for Public Integrity, a public interest investigative journalism organization, has obtained copies of a Centers for Disease Control and Prevention (CDC) study of environmental and health data in eight Great Lakes states that was scheduled for publication in July 2007. The report, which pointed to elevated rates of lung, colon, and breast cancer; low birth weight; and infant mortality in several of the geographical areas of concern has not yet been made public.

A few days before the report was slated to be released, it was pulled. Meanwhile, at precisely the same time, its lead author, Christopher De Rosa, has been removed from the position he held since 1992.  The Center for Public Integrity is asking why.

The study, “Public Health Implications of Hazardous Substances in Twenty-Six U.S. Great Lakes Areas of Concern” was developed by the CDC’s Agency for Toxic Substances and Disease Registry (ATSDR) at the request of the International Joint Commission, an independent U.S-Canadian organization that monitors and advises both governments on the use and quality of boundary waters.

The CDC report brings together two sets of data: environmental data on known "areas of concern" — including superfund sites and hazardous waste dumps — and separate health data collected by county or, in some cases, smaller geographical regions.

The study does not try to prove cause and effect. Instead, it outlines areas for further study and data collection on the link between pollution and health.

"Let’s say we have a superfund site and we also find elevated risk of leukemia in the county — is that related? We don’t know, but people living in the area can logically argue that we ought to find out," Dr. Peter Orris, a professor at the University of Illinois School of Public Health and one of the peer reviewers of the study told Oneworld.net.

Since 2004, dozens of experts have reviewed various drafts of the study, including senior scientists at the CDC, Environmental Protection Agency, and other federal agencies, as well as scientists from universities and state governments, according to consumeraffairs.com. Orris is just one of the several experts who reviewed the study and who, along with the International Joint Committee in a December letter to the CDC, have called for the report’s publication.

Continue reading →