The Origins of the Cholesterol Con, Part II

Last week, I wrote about the “cholesterol con,” the widespread belief that “bad Cholesterol” ( LDL cholesterol) is a major factor driving heart disease, and that cholesterol-lowering drugs like Lipitor and Crestor can protect us against fatal heart attacks. These drugs, which are called “statins,” are the most widely-prescribed pills in the history of human medicine. In 2007 world-wide sales totaled $33 billion. They are particularly popular in the U.S., where 18 million Americans take them.

We thought we knew how they worked. But last month, when Merck/Schering Plough finally released the dismal results of a clinical trial of Zetia, a cholesterol-lowering drug prescribed to about 1 million people, the medical world was stunned. Dr. Steven E. Nissen, chairman of cardiology at the Cleveland Clinic called the findings “shocking.”  It turns out that while Zetia does lower cholesterol levels, the study failed to show any measurable medical benefit.

This announcement caused both doctors and the mainstream media to take a second look at the received wisdom that “bad cholesterol” plays a major role in causing cardiac disease. A Business Week cover story asked the forbidden question, “Do Cholesterol Drugs Do Any Good?" 

The answer, says Dr. Jon Abramson, a clinical instructor at Harvard Medical School, and the author of  Overdosed America, is that “statins show a clear benefit for one group—people under 65 who have already had a heart attack or who have diabetes. But,” says Abramson,  “there are no studies to show that these drugs will protect  older patients  over 65—or younger patients who are not already suffering from diabetes or established heart disease –from  having a fatal heart attack. Nevertheless, 8 or 9 million patients who fall into this category continue to take the drugs, which means that they are exposed to the risks that come with taking statins –which can include severe muscle pain, memory loss, and sexual dysfunction.”

Finally—and here is the stunner—it turns out we don’t have any clear evidence that statins help the first group by lowering cholesterol levels.  It’s true that they do lower cholesterol, but many researchers are no longer convinced that this is what helps patients avoid a second heart attack. It now seems likely that they work by reducing inflammation. In other words, these very expensive drugs seem to do the same thing that aspirin does.  (Are they more effective than the humble aspirin? We’ll need head-to-head studies to find out.)

Update on FDA Stories: Business as Usual

In my last two posts, I touched on some pretty significant FDA-related developments—and even though they’re barely a week old, a lot has happened since my commentary. Here’s a look at where things stand now. It’s not pretty.

The FDA, Avastin, and Wall Street

In a post last week, I urged the FDA not to approve Avastin for use with breast cancer patients, because (1) the science shows it’s not effective enough to warrant approval and (2) giving it the okay would set a precedent for approving mediocre drugs..

Naturally, the FDA approved Avastin at the end of last week.

In a comment quoted by MarketWatch, analysts called the FDA’s decision “a welcome outcome” because "investors and companies have expressed growing concern that the FDA's hurdle for approving drugs is a moving target and that a survival benefit is a necessity.”

But wait—just last week the Wall Street Journal noted that FDA “evaluation methods have remained largely unchanged over the last half-century.” In fact, the Journal cited this long-term consistency as emblematic of the agency’s “bureaucratic culture”—and yet here are the analysts, claiming that the problem is inconsistency.

Of course, the logic behind approval is a secondary concern to investors—what really matters is the financial consequences of an FDA decision. In this case the green light from the FDA sent Genentech shares shooting up by almost 10 percent in a single day. Predictably, financial analysts see big things in the company’s future: the investment bank Cowen & Co. forecasets  a peak potential sales estimate of $1.5 billion in 2012 and RBC Capital Markets analysts have upped their 2008 and 2009 sales forecasts by $17 million and $30 million respectively (the drug’s 2007 sales already clocked in at a whopping $2.7 billion).

As the Army Approaches a Breaking Point

Since 9/11, one Army division has spent more time in Iraq than any other group of soldiers: the 10th Mountain Division, based at Fort Drum, New York.

Over the past 6 years and and six months, their 2nd Brigade Combat Team (BCT) has been the most deployed brigade in the army. As of this month, the brigade had completed its fourth tour of Iraq. All in all, the soldiers of BCT have spent 40 months in Iraq.

At what cost?  According to a February 13 report issued by the Veterans for America Wounded Warrior Outreach Program, it is not just their bodies that have been maimed and, in some cases, destroyed. Many of these soldiers are suffering from severe mental health problems that have led to suicide attempts as well as spousal abuse and  alcoholism.

Meanwhile, the soldiers of the 2nd BCT have been given too little time off in between deployments:
In one case they had only six months to mentally “re-set”  following an eight-month tour in Afghanistan–-before beginning a 12- month tour in Iraq.

Then, in April 2007, Secretary of Defense Robert Gates decided to extend Army tours in Iraq from 12 to 15 months—shortly after the BCT had passed what it assumed was its halfway mark in Iraq.

As the VFA report points out:  “Mental health experts have explained that ‘shifting the goalposts’ on a soldier’s deployment period greatly contributes to an increase in mental health problems.”

The Supreme Court’s Medical Device Decision Misses the Point

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.

The Wall Street Journal Is Wrong on Avastin

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.

A Lesson in Health Care Innovation...from the Government?

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.

The Cholesterol Con--Where Were the Doctors? Part I

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.

Final Update On "Checklist"

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.

Can Insurers Add Value?

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.

A Blueprint for Healthcare Reform

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.

In Defense of "The Downsides"

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.

Will Consumer-Driven Medicine Really Cut Health Care Costs?

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.

Government Suppresses Public Health Report

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.

How Much Do We Really Know About Canadian Healthcare?

A reader sent me this provocative piece on Canadian healthcare, written by someone who knows care on both sides of the border. It comes from the Campaign for America’s Future website. And it is, as advertised, a “myth-buster.” I look forward to Part II.

Mythbusting Canadian Health Care Part I                
By Sara Robinson                
February 4th, 2008

2008 is shaping up to be the election year that we finally get to have the Great American Healthcare Debate again. Harry and Louise are back with a vengeance. Conservatives are rumbling around the talk show circuit bellowing about the socialist threat to the (literal) American body politic. And, as usual, Canada is once again getting dragged into the fracas, shoved around by both sides as either an exemplar or a warning -- and, along the way, getting coated with the obfuscating dust of so many willful misconceptions that the actual facts about How Canada Does It are completely lost in the melee.

I'm both a health-care-card-carrying Canadian resident and an uninsured American citizen who regularly sees doctors on both sides of the border. As such, I'm in a unique position to address the pros and cons of both systems first-hand. [my emphasis –mm] If we're going to have this conversation, it would be great if we could start out (for once) with actual facts, instead of ideological posturing, wishful thinking, hearsay, and random guessing about how things get done up here.

To that end, here's the first of a two-part series aimed at busting the common myths Americans routinely tell each other about Canadian health care. When the right-wing hysterics drag out these hoary old bogeymen, this time, we need to be armed and ready to blast them into straw. Because, mostly, straw is all they're made of.

1. Canada's health care system is "socialized medicine."

False. In socialized medical systems, the doctors work directly for the state. In Canada (and many other countries with universal care), doctors run their own private practices, just like they do in the US. The only difference is that every doctor deals with one insurer, instead of 150. And that insurer is the provincial government, which is accountable to the legislature and the voters if the quality of coverage is allowed to slide.

The proper term for this is "single-payer insurance." In talking to Americans about it, the better phrase is "Medicare for all."

2. Doctors are hurt financially by single-payer health care.

True and False. Doctors in Canada do make less than their US counterparts. But they also have lower overhead, and usually much better working conditions. A few reasons for this:

First, as noted, they don't have to charge higher fees to cover the salary of a full-time staffer to deal with over a hundred different insurers, all of whom are bent on denying care whenever possible. In fact, most Canadian doctors get by quite nicely with just one assistant, who cheerfully handles the phones, mail, scheduling, patient reception, stocking, filing, and billing all by herself in the course of a standard workday.

Hispanic Women: Americanized Diets and Premature Births

The newest issue of the medical journal Obstetrics and Gynecology contains a compelling study by R. Jeanne Ruiz of the University of Texas and colleagues. The team looked at 468 low-income pregnant Hispanic women to see how much levels of acculturation (measured by proficiency in English) affected premature birth. What they found is not what you might expect: those mothers who are better assimilated are more than four times as likely to give birth to a premature baby.

That’s right: Women who were born outside the U.S., had not completed high school, were not proficient in English, and had lived in the U.S. for fewer than 10 years were more likely to have higher levels of progesterone. (Researchers have found that a form of the hormone progesterone can reduce the rate of premature births).

This is pretty counter-intuitive—poor and poorly assimilated women with low levels of education are in one important respect healthier than their more Americanized peers. What gives?

While the article is primarily concerned with pointing the distinction rather than trying to explain it, the general message is clear: there’s something different about the way unassimilated low-income Hispanic women live their lives. The obvious distinction is diet and nutrition. I think it’s fair to say that the more someone is tied to his or her culture of origin, the more likely he or she is to consume that culture’s traditional diet. 

Hispanics are a broad group, so it’s tough to pinpoint exactly what “less American” Hispanics eat that “more American” Latinos don’t. On the whole, however, the Hispanic diet is much heavier in grains, beans, and fresh fruits and vegetables than the typical American meal. And studies have actually shown that Spanish-speaking Hispanics stick closer to this diet than their English-speaking peers who are more like pick up American eating habits.

Guess who eats healthier?

In 2000, the Department of Agriculture studied diet and nutrition among Hispanics in the U.S. Rating diet quality on a “healthy diet index” drawn from government nutrition recommendations and the food pyramid, the authors found that less assimilated Spanish-speaking adults and children scored higher than their English-speaking counterparts (see table below). In other words, less acculturated Latinos eat better—mostly because they consume less fat and more fiber in their diets.

Early Stage Prostate Cancer: "No Evidence That Treatment Is Better Than No Treatment"

Today, the New York Times reported on a “troubling new report from the Agency for Healthcare Research and Quality (AHRQ), which analyzed hundreds of studies in an effort to advise men about the best treatments for prostate cancer. The report compared the effectiveness and risks of eight prostate cancer treatments, ranging from prostate removal to radioactive implants to no treatment at all. None of the studies provided definitive answers. Surprisingly, no treatment emerged as superior to doing nothing at all. [my emphasis]

“When it comes to prostate cancer, we have much to learn about which treatments work best,” said agency director Carolyn M. Clancy. “Patients should be informed about the benefits and harms of treatment options.”

The Times went on to quote the agency saying “Considerable over-detection and over-treatment may exist.” 

I have written about this issue here  and here; Niko has written about it here.

I am not going to repeat what we have said in the past. But let me emphasize that the AHRQ looked at practically every treatment now being used:

“The agency review is based on analysis of 592 published articles of various treatment strategies. The studies looked at treatments that use rapid freezing and thawing (cryotherapy); minimally invasive surgery (laparoscopic or robotic-assisted radical prostatectomy); testicle removal or hormone therapy (androgen deprivation therapy); and high-intensity ultrasound or radiation therapy. The study also evaluated research on ‘watchful waiting,'’ which means monitoring the cancer and initiating treatment only if it appears the disease is progressing.”

The agency goes on to warn that “all active treatments cause health problems, primarily urinary incontinence, bowel problems and erectile dysfunction.”

Finally, the Times points out that while “one study has shown that men who choose surgery over watchful waiting are less likely to die or have their cancer spread, another study found  no difference in survival between surgery and watchful waiting.” Moreover—and this is important—“few patients in the study had cancer detected through P.S.A. tests. As a result, it’s not clear if the results are applicable to the majority of men diagnosed with the disease.”

David Brooks, Clinton, Obama – And, Wait A Minute, Whose HealthCare Plan is More “Coercive”?

The worst thing that a journalist can do is to present opinion as fact—especially when talking about something important. To do it on Super Tuesday is particularly irresponsible.

Yet that is exactly what conservative columnist David Brooks has done in today’s New York Times.

Responding to what Paul Krugman wrote yesterday (see my post below, “But There Is A Difference Between Obama and Clinton on Healthcare”), Brooks attacks Hillary Clinton for insisting that if we want universal healthcare, we are going to have to ask everyone to get into the pool. Rich and poor, young and old, healthy and sick—everyone will need to contribute to the national healthcare fund by signing up for insurance. Otherwise, we won’t be able to afford the subsidies that low-income and working class families will need to enroll in the plan.  Hillary’s mandate is much like the mandate that we all contribute to Social Security or Medicare.

As Brooks sees it, the issue “is over whether to use government to coerce people into getting coverage. The Clintonites argue that without coercion, there will be free-riders on the system.”

In other words, the Clintonites are concerned that young, healthy people who earn too much to qualify for subsidies may not sign up—especially since, under healthcare reform, they will know that once they do get sick, insurers will be required to cover them and will not be allowed to charge them more than they charge everyone else. Thus, while older, sicker people pay into the pool, younger healthier people will get a “free ride”—until they need insurance.   

“They’ve got a point,” Brooks admits briefly, referring to Clinton’s position.  It’s really rather hard to argue with common sense. “But,” he adds, “there are serious health care economists on both sides of the issue.”

Who exactly does he have in mind?  Brooks doesn’t say.

The Downsides of Virtual Medicine

I love the Internet. I love convenience, and technology. The creation of new inequalities at a time of profound disparities in health care, however, isn’t my cup of tea. So I have mixed feelings about the fact that online medical consultations are gaining steam.

On the one hand, the pluses are obvious. As I’ve written in a previous post, Tom Delbanco from Harvard Medical School estimates that 50 percent of visits to the physician are unnecessary and could probably be dealt with online. Yet a measly eight percent of doctors use e-mail to communicate with patients, let alone set up their webcam to talk shop. That seems foolish.

But, Doubting Thomas that I am, I see some problems with the rise of Internet consultation. Ultimately it seems like another case of wrong-headed priorities. Once again, too much attention is paid to dispensable improvements that don't address fundamental problems with our health care system. Enough with the bells and whistles already. 

Traditionally, the biggest obstacle to online consultation was the fact that insurance companies didn’t reimburse doctors for web-based work. But recently Aetna and Cigna, two of the nation’s biggest insurers, have agreed to reimburse doctors for online visits. Other big dogs in the insurance world are likely to follow suit soon.

With these changes, the anatomy of the web-doc industry is beginning to come into focus. For online consultation to be reimbursed by insurers, paperwork needs to be filled; for doctors to have a booming Internet practice, they need a strong online presence. To help with both of these matters, new companies have entered the fray, with cookie-cutter names like RelayHealth and Medem (“medicine” + “modem”; genius!).

The L.A. Times describes how these companies work:

To begin using these online services, patients visit a doctor's website or go directly to one of the Internet companies that handle such services…Doctors are typically encouraged to respond to patients within a day; they receive an e-mail reminder if they haven't, with a phone call on the second day. Prices can vary from $25 to $125, which patients pay with a credit card at the end of the session.

Super Tuesday, the Candidates and Healthcare Reform

Today, I talked to Bob Blendon, who is a professor of health policy and political analysis at Harvard’s Kennedy School of Government, about Super Tuesday’s multi-state primary contests and what they might mean for healthcare reform.

Blendon agrees with the consensus on the Democratic race. Hillary Clinton and Barack Obama are running nose to nose, but Blendon points out, if you take a closer look at the polls, you find an unusual contradiction.  Not only are the voters split between the candidates; there are very split, within themselves.

“When you ask about the issues, Clinton wins on almost every point, including healthcare,” Blendon reports.  But when you ask about character, likability, leadership, ability to inspire—Obama is the clear favorite.

“Usually, people can’t live with that much incongruence,” Blendon adds. “Once they decide who they like, then they decide that person is the best on the issues. Normally, people don’t like incongruence within themselves.”

But There Is a Difference between Obama and Clinton on Healthcare

In the post above I quote Harvard professor of health policy and political analysis at Harvard’s Kennedy School of Government Bob Blendon as saying that voters perceive little difference between Obama and Clinton on healthcare reform. And I think he’s right. But that’s because most voters haven’t honed in on the fine points of their plans.

Those who have scrutinized the plans, and understand the economics of healthcare reform, see important differences—differences that could be deal-breakers.

In today’s New York Times, Princeton economist Paul Krugman argues that because Obama’s plan does not require everyone to sign up for insurance, it would be more expensive—and thus less likely to pass Congress. Without a mandate, Obama’s plan “would face the problem of healthy people who decide to take their chances or don’t sign up until they develop medical problems, thereby raising premiums for everyone else,” Krugman points out. He acknowledges that “Mr. Obama, contradicting his earlier assertions that affordability is the only bar to coverage, is now talking about penalizing those who delay signing up — but it’s not clear how this would work.”

Writing on The American Prospect today, economist Dean Baker from the Center for Economic and Policy Research responds to Krugman, saying that he knows how penalties would work:

“Obama has suggested that we can have a system of default enrollment, whereby people are signed up for a plan at their workplace.

“People would then have the option to say that they do not want insurance, so they are not being forced to buy it. However, they will then face a late enrollment penalty if they try to play the ‘healthy person’ game. When they do opt to join the system, at some future point, they will have to pay 50 percent more for their insurance, or some comparable penalty for trying to game the system. “

What Baker doesn’t say is what we will do with families who cannot afford to pay such stiff penalties when they finally decide they need insurance. Would we subsidize the penalties?

A New Look for HealthBeat—With Bigger Type

Health Beat Blog is getting a new look. Some of you have asked for larger type, so we’ve re-designed the blog to make it more readable, while including a few extra features-- including a link to our “Most Read Posts.”

We’re rolling out the new design on Monday, February 4. If something isn’t displaying property, please be sure to refresh your browser. In Internet Explorer, this is the button with green arrows to the right of the address bar (F5) and in Firefox, this is the blue arrow button to the left of the address bar (Ctrl+R).

Fudging the Stats: Drug Companies and the “Number Needed to Treat”

Earlier this month, I wrote briefly on how the relationship between high cholesterol and heart disease is growing murkier than has been traditionally assumed. Today, by way of Gary Schwitzer’s Health News Blog, I came across a recent BusinessWeek article by John Carey that cracks this story wide open—in part by addressing an incredibly important, but often misunderstood and misused—statistic: the “number needed to treat.”

The succinctly titled piece, “Do Cholesterol Drugs Do Any Good?,” notes that “Americans are bombarded with the message from doctors, companies, and the media that high levels of bad cholesterol are the ticket to an early grave and must be brought down. According to these ubiquitous messages, statins [cholesterol-lowering drugs like Lipitor] “are the most potent weapons in that struggle.” Carey notes that Lipitor advertisements claim that the drug “reduces the risk of heart attack by 36 percent…in patients with multiple risk factors for heart disease." Sounds pretty effective, right?

Hold the phone—there’s more to that number than meets the eye. Carey notes that the 36 percent is accompanied by an asterisk stating that “in a large clinical study, 3 percent [or three out of every hundred] of patients taking a sugar pill or placebo had a heart attack compared to 2 percent [or two out of every hundred] of patients taking Lipitor."

Now, Pfizer’s number isn’t an outright lie. Pfizer, Lipitor’s manufacturer, says its potion reduces risk by  36 percent because the difference between two patients getting a heart attack on Lipitor and three patients getting a heart attack on placebos is one patient—or about a third the number of heart attacks that would have happened without Lipitor.

How Do We Fund National Health Reform?

Do we know enough about measuring the quality of healthcare to pick out the best doctors?

When I asked Don Berwick that question last week, he spread his hands: “You’re looking at the cream of crap. The system is so broken,” he explained, “that even the high performers are far away from optimal performance.  Most measures of quality are simply measuring the system that the doctor is trapped in, not the doctor himself.”

Who is Don Berwick, and why is he saying such terrible things about our healthcare system?

Dr. Donald Berwick, President and Chief Executive Officer of the Institute for Healthcare Improvement (IHI), is widely recognized as one of the world’s most respected experts on healthcare quality. In 2005, Modern Healthcare, a leading industry publication, named Berwick the third most powerful person in American medicine.  In contrast to others on Modern Healthcare’s list, Berwick “is not powerful because of the position he holds,” noted Boston surgeon and author Atul Gawande. (Former Secretary of Health and Human Services Tommy Thompson ranked no. 1 on the list while Thomas Scully, the head of Medicare and Medicaid Services, captured the second spot).  “Berwick is powerful,” Gawande explained, “because of how he thinks.”

When Berwick thinks about the U.S. healthcare system, the word he uses is “bloated.” There’s a myth that American healthcare is the best in the world,” he noted at a Families USA conference last week. “It’s not,” he said bluntly. “It’s not even close.”

“It’s thought to be the best because we have the most healthcare,” Berwick told his audience. But in fact, although we spend twice as much as the average developed country providing more care than any other nation in the world “40 percent of the care that Americans actually need is not received.” Why?

“Cost is the barrier.”

“Here is a question I often ask my students,” added Berwick, who is a Professor of Pediatrics at Harvard. “When you meet a new patient, what is the one test that you could do that would tell you how long that patient is likely to live?

Typically, students answer: “Ask them if they smoke,” or “Test their blood sugar.”

“No,” says Berwick, “Just look at the color of their skin.”