McCain's Plan

What was most notable about presumptive Republican nominee John McCain's health care plan unveiled Tuesday was the campaign's unrealistic assessment of its impact on people with life-threatening conditions like cancer, the millions of Americans with chronic disease like diabetics, or preventive care. Instead of promising to expand insurance, as the Democrats are offering, McCain fully embraced the individual private insurance model cooked up by conservative think tanks overly enamored of free market medicine, which no place on earth other than the U.S. takes seriously.

Like President Bush's proposal which the Democratic Congress dismissed out-of-hand, the McCain plan would end the federal subsidy to employers for providing health insurance and give it as a tax credit to individuals ($2,500) and families ($5,000). This is about half what a family plan costs today, leaving the average family of four needing to pay around $400 a month for coverage comparable to what they now have.

You don't have to be a rocket scientist to see that in today's economy, many relatively healthy families who are currently uninsured will choose to underinsure, buying plans without first dollar coverage (whoops, there goes preventive care), with high deductibles and co-pays for routine care (huge extra bills for people with chronic disease), and that limit coverage for expensive cancer drugs (the so-called Tier 4 drugs) and put a cap on total coverage.

The plans authors claimed many employers would continue to provide insurance to retain their best employees. Don't they believe their own free market rhetoric? By removing the tax break, they would create a powerful incentive for even the most well-heeled companies to cap their health care expenses by offering flat payments in addition to the government credit. Over time, as health care costs continued to rise, more and more Americans through their individual choices would find themselves in the chronically underinsured pool.

McCain's answer to the uninsured and underinsured that his plan would leave behind is a new health care welfare system. Er, I mean a safety net. The campaign would create a federal-state program (capped, he reserved his strongest language for his refusal to create an unfunded mandate) that paid for uncompensated care delivered at hospitals. According to the New York Times, McCain's top domestic policy adviser, Douglas Holtz-Eakin, estimated the federal share would be about $7 billion and $10 billion.

I doubt that estimate would fly at the Congressional Budget Office that Holtz-Eakin used to run. With 47 million uninsured, with millions of people already underinsured because of the inadequacies in their employer-provided plans, and with millions more choosing to become underinsured because of the inadequacy of the tax credits offered in McCain's plan, can he really think the federal portion of the safety net will amount to just one-half of one percent of our annual health care bill?

If they actually capped it at $10 billion, that wouldn't be a safety net. That would be Swiss cheese in a sandwich without bread, lettuce or meat.

Merck Effort to Enter Supplement Biz Suffers Setback

Niacin or Vitamin B, commonly available as an over-the-counter supplement, works fairly well to lower bad cholesterol and raise good cholesterol with one major problem -- it causes severe flushing in many people. Merck thought combining it with an anti-flushing prescription drug, laropiprant, would solve that problem, and open a new vein in the anti-cholesterol gold mine for the faltering drug giant. It hoped to generate $2 billion from the drug, called Cordaptive.

The FDA's "not approvable" letter for Cordaptive, issued Monday, struck a blow to those hopes. Merck didn't say what the FDA's concerns were with Cordaptive, but they may center on laropiprant, the long-term effects of which have not been studied. "We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of (Cordaptive)," Peter Kim, who runs Merck's research labs, said in a press release.

In October 2006, Merck launched a clinical trial in patients with inherited high cholesterol to study Cordaptive's effect on plaque buildup in the arteries. But the company suspended the trial after the unimpressive results of the Vytorin trial (ENHANCE, which also measured plaque) were announced.

Now Merck is studying Cordaptive in a trial called THRIVE, which plans to measure actual outcomes. However, that trial has been criticized on the grounds that it compares Cordaptive to placebo, not niacin (both arms get a generic statin). So clinicians will not be able to know the long-term effects of laropiprant.

That may explain why the FDA questioned this drug. Laropiprant binds to a receptor that some animal studies suggest may have neuroprotective effects, raising the need to evaluate its safety. -- PM

Nothing But Nets

No, this isn't a column about the imminent elimination of my hometown Wizards from the NBA playoffs.

I was remiss last week by not commenting on World Malaria Day. More than a million people around the world die each year from the mosquito-borne scourge, most of them children. International health agencies and foundations are mobilizing resources to combat the disease. As regular readers know, I have written about anti-malarials, especially the artemisinin-based drugs derived from traditional Chinese medicine. But they are just one leg of the three-pronged strategy that can be used to eradicate the disease in an area. The other two are indoor residual spraying (where the quality of housing allows it) and widespread use of bednets.

There are controversies involved in the deployment of bednets in Africa, where malaria prevalence is most pronounced. Should the nets be distributed free, or sold through "social marketing" so that people will value them and help stimulate the local economy? The New York Times this morning didn't address the distribution question, but did note that there is a global shortage of bednets that could be addressed through greater charitable efforts.

Want to help out? I donated $25 last Friday to the Nothing But Nets campaign, jointly sponsored by the NBA and the UN Foundation. Why don't you join me. You can make your own donation by CLICKING HERE.

More Evidence of Our Collapsing Health Care System

If you didn't see the story in yesterday's Wall Street Journal on hospitals demanding upfront payments for cancer treatment, it is must reading. It documents what can happen when individuals have to buy their own insurance and get seriously ill after purchasing "limited insurance" policies.

Is the FDA Getting Tough on Surrogate Markers?

Allow me to introduce readers to PM, who will be guest blogging in this space from time to time. PM follows developments at the FDA closely.

Last week's surprise decision from the Food and Drug Administration that it will require a new cholesterol-lowering drug from ISIS Pharmaceuticals and Genzyme to actually reduce mortality from coronary artery disease may signal a subtle but significant shift in agency policy when approving new drugs that affect surrogate markers.

Cardiovascular (CV) surrogate markers are risk factors like high blood pressure, elevated blood sugar, low HDL cholesterol levels, and elevated LDL cholesterol levels that are associated with increased risk of heart attacks and strokes. In approving new drugs designed to prevent and treat CV disease, the FDA has often relied on improvements in the "surrogate endpoints," not the outcomes patients really care about -- reduced risk of heart attacks, strokes, heart failure and death. 
 
That approach has been unevenly applied over the years. Last month in The Journal of the American Medical Association, Bruce Psaty and Thomas Lumley noted the contrasting paths followed by the FDA with respect to two lipid-altering drugs, ezetimibe (Zetia and a component of Vytorin) and torcetrapib.  In the case of torcetrapib, a drug that raised "good" cholesterol (HDL) and lowered bad cholesterol (LDL), the sponsor carried out the ILLUMINATE trial, in which 15,057 patients with high CV risk were randomized to receive torcetrapib plus atorvastatin (Lipitor) or atorvastatin alone.  Although patients who received torcetrapib had higher HDL and lower LDL than patients who did not, the trial was stopped early because of an increase in the risk of CV events and total mortality in the torcetrapib group.  Pfizer subsequently halted the development of torcetrapib.
 
By contrast, ezetimibe was approved in October 2002 on the basis of its ability to reduce levels of LDL alone.  Clinical trials evaluating ezetimibe's impact on the risk of CV events were slow to start. Indeed, the ENHANCE trial, which evaluated the effect of ezetimibe on atherosclerosis, was not completed until 2006 -- four years after approval -- and the results were not reported until January of thsi year. Guess what? No effect on atherosclerosis was shown.

A large trial, IMPROVE-IT, to evaluate the effect of ezetimibe on CV events will not be completed until at least 2012.  If ezetimibe is ultimately shown to have no benefit for the prevention of CV events, thousands of patients will have been treated with an ineffective drug when more effective drugs were available.
 
Which brings us to this weekend's surprise announcement. Mipomersen, an LDL-lowering drug, is being developed by Isis Pharmaceuticals in partnership with Genzyme Corp.  While the sponsors announced Friday that the FDA was permitting reduction of LDL to be used as a surrogate endpoint for accelerated approval of mipomersen for patients with genetically-inherited high cholesterol (known as homozygous familial hypercholesterolemia or hoFH), the agency will require the companies to conduct a very large clinical trial with real clinical endpoints (heart attacks, strokes, death) if they want to expand its use to the broader population with high cholesterol levels.

It is unclear whether this represents a new FDA approach to approval of lipid-altering drugs when they are first-in-class, or whether the FDA has special concerns with mipomersen. The FDA has asked the companies to include data from two ongoing preclinical studies for carcinogenicity when it submits its filing in 2010, a year later than expected. Whatever the FDA's reason, it's the right approach to take. --PM

Industry Gifts Ban Urged, Speaker Fees "Discouraged"

A task force representing the nation’s 125 medical colleges has recommended a ban on gifts and free meals for students and faculty and stricter regulations of industry visits on campus. But the Association of American Medical Colleges, whose executive council will consider the proposal in mid-June, stopped short of calling for prohibiting faculty members from consulting or speaking on behalf of drug and device companies, or for eliminating industry’s role in financing continuing medical education (CME).

“Clear and well-though-out guidelines will optimize the benefits inherent in the relationship between academic medicine and industry and minimize the risks,” the report said.

The 30-member task force was chaired by Roy Vagelos, former chairman of Merck, and included the CEOs of Pfizer, Medtronic, Amgen and Eli Lilly. The latter two dissented from the report’s recommendations “strongly discouraging” participation in speakers’ bureaus. The report closely followed a proposal made two years ago by Columbia University’s Institute on Medicine as a Profession with one exception. That report called for academic physicians to abandon participation in industry speakers’ bureaus, which it called “an extension of manufacturers’ marketing apparatus.”

Besides banning gifts, the guidelines called for centralized management of free drug samples or, where that is not possible, some alternative that does “not carry the risks to professionalism with which current practices are associated.” Drug and device salesperson visits with individual physicians should be restricted to non-patient areas and by appointment or invitation only.

On speaking and consulting, the report suggested “to the extent that academic medical centers choose to allow participation of their faculty and staff in industry-sponsored, FDA-regulated programs, they should develop standards that define appropriate and acceptable involvement,” which was defined as full transparency and payment “at fair market value.”

Rather than eliminating industry’s role in financing CME, which now accounts for more than half of the $2 billion industry, the AAMC task force recommended that the money be deposited in a centralized fund. It also recommended establishing school-level audit committees to monitor CME activities to ensure they follow conflict-of-interest guidelines established by the Accreditation Council for Continuing Medical Education. At an Institute of Medicine hearing in March, the Center for Science in the Public Interest urged organized medicine to encourage physicians to eliminate the middleman and pay directly for their own continuing education since patients and consumers already paid indirectly for CME through higher drug and device prices.

The version of this story originally appeared in Integrity in Science Watch, a publication of the Center for Science in the Public Interest.

Housing -- Good or Bad Investment for the Little Guy?

With housing prices falling sharply in some areas of the country and stagnant on most others, many people are beginning to wonder if that traditional symbol of achieving the American dream -- home ownership -- is a wise investment. The Washington Post business section on this gray and gloomy Sunday in the nation's capital weighs in with a front page story from which casual readers will draw that incorrect conclusion. It is based on an incorrect assumption: that stocks have provided higher returns than housing over the long-term.

The story is accompanied by a chart from the National Association of Realtors comparing investments of $48,700 in either the median home or a Standard & Poor's 500 index fund in 1978. According to the chart, over the next 30 years that home would have appreciated 347 percent to $218,000. The basket of stocks, on the other hand, would grown a stunning 1,438 percent to $749,000.

That's an average annual return of 5.3 percent for the house, barely ahead of inflation, compared to nearly 10 percent for stocks, according to the chart. Slam dunk for stocks, right?

Alas, the author and the Post editors left out the critical factor in evaluating any investment: how much capital is actually invested to earn those returns. A typical homeowner in 1978 (and we're rapidly returning to those days of typicality as the financial finagling in home mortgage markets gets swept away) put 20 percent down on a home and took out a mortgage for the rest. So for that $48,700 house, the actual amount invested was $9,740; with closing costs, it can be rounded to a neat $10,000.

Let's forget for a moment that this homeowner over the years also got a substantial subsidy from the federal government for the interest paid on his mortgage. Let's also forget about the taxes paid on the dividends and capital gains earned from the stocks. (These factors are mentioned near the end of the story, just like the debt-to-equity issue, but neither are factored into the front-page chart calculation).

If we only look at the return of the house compared to the initial investment, we get a percentage increase of 1,690 percent. That's 200 percent more than the return from stocks.

It's testimony to the power of leverage, and homeownership remains one of the few areas in life where average people get to exert its almost magical powers. (You can buy stocks on margin, too, but few individual investors do since most invest through mutual funds.)

Of course, leverage has an equally powerful effect on the downside. When home prices plunge, equity in a home can quickly be wiped out. That's what happened to families that bought overpriced homes at the peak of the bubble with highly leveraged or no-equity loans.

But that's a relatively small sliver of the market. For most people, homeownership remains their number one source of household savings, and will remain so for the foreseeable future. It's almost shocking that a major American newspaper could so fundamentally misrepresent these basic realities of household finance.

Krugman's Confusion

Paul Krugman of the New York Times is one of my favorite columnists. And even though I voted for Barack Obama in the Maryland primary, I respect his pro-Hillary Clinton drumbeat of criticism aimed at Illinois' junior senator because I believed, until recent weeks, that spirited intellectual competition would sharpen both candidates for the bruising struggle ahead. I want the Democrats to win back the White House in the fall, a must in my view if we're going to get this country back on track. In the end, I'm a Yellow Dog Democrat. I'll gladly vote for either of them over John McCain, who promises us endless war in the Middle East and, on domestic issues, is a transparently duplicitous character getting a free pass from an infatuated national media.

As was apparent from the earliest days of this campaign, Clinton's greatest strength is among working class voters, educated women and older Democratic voters -- all for obvious reasons. The first constituency is crucial, since the others will go Democratic no matter who gets the nomination. The last time workers got a raise in this country was in the late 1990s. We're heading back into tough economic times. I don't think there's a dime's worth of difference between the two candidates on how they'd manage the economy, but trusting someone clearly associated with the last successful Democratic administration seems like a perfectly reasonable response to me.

But in today's column, Krugman attacks Obama for running ads stressing Clinton's support for making purchasing health insurance mandatory, and then suggests Obama's supporters have to be asking themselves "what is this campaign about?"

I don't want to rehash the wonkish debate over mandates. I know a lot about health care. I don't think they're necessary to get to near universal coverage. I think they're a trap politically. And they could be a trap as a system if they're not structured the right away, which is being proved right now in Massachusetts. Why should either Democratic candidate sign on in advance to this particular aspect of health insurance reform? It's precisely what a wonkish candidate who thinks they have all the answers would propose.

But that said, to suggest that there is no rationale for the Obama candidacy, as Krugman did this morning, begs a single word response: Iraq. Not once did he mention that word in his column. Not once did he mention foreign affairs. He only says that the Democrats need to position themselves as the party of prosperity in the fall, and that Clinton is the best candidate to do that.

What he ignores is going to be the main text of this year's fall campaign: What is America's approach going to be moving forward in its relations with the rest of the world? What face are we going to show a world where resources are increasingly constrained yet expectations are rising in its once-poor and still-poor precincts? Over the next couple of weeks, as these two excellent candidates engage in the final rounds of this long campaign, the debate should turn to who is best suited to turning the page on the failed policies of the recent past.

In November, Americans deserve a clear choice on how this country is going to handle Iraq, terrorism, oil, clean energy, and our relations with the developing world. Then, if they choose McCain, at least we will have walked eyes wide open into a future where there are even greater failures and more deaths and squandered treasure to come.

But Isn't That Socialized Medicine?

It was one of those storied occasions impossible to pass up. The President of the United States gathered leaders from both political parties on the White House lawn to honor a true medical genius, Dr. Michael E. DeBakey, the surgeon who was one of the first to conduct coronary bypass surgery. DeBakey, the child of Lebanese immigrants who turns 100 this year, did most of his pioneering work at Baylor in Texas, giving President Bush a few laugh lines at his home state's expense.

But then it was DeBakey's turn. From his wheelchair, he offered these words to the Congresspersons in attendance as they contemplate tackling health care reform:

I want to make a suggestion to the Congress about health care. I know that you have been working on this for many, many years. In fact I was one of President Kennedy's strongest supporters when he came out with Medicare when the medical profession was strongly against. I thought it was a great idea. I still think it's a great idea. Unfortunately, it's practical effect has not been that great. So I know you have sought a better health care plan for the needy. And unfortunately it has been elusive. But there is a model you should look at that I'm thoroughly familiar with because when I was in the military, I was assigned by the Surgeon General to the committee that (Gen. Omar) Bradley and (Rear Admiral Jean Hodgkin) Hawley worked on in fixing up the Veterans Administration. We made many suggestions that resulted in a superb medical service. I've been familiar with the medical services of the Veterans Administration since then. In fact, I developed their research program. I assure you that you can't find a better model. For one thing, its quality of care is superior. And for another, it provides that care at half the cost of other agencies both in and out of government. So you see how efficient it is. So there must be something about what they are doing that we could use to expand our program in health care for the needy.

I wonder what the president thought as DeBakey uttered those words. I wonder if Congress was listening.

Riskless Business

There's still a part of me that's a business reporter, so I couldn't help but notice the profit reports pouring in from drug and device firms in recent days. If I were to write a headline on a round-up story, it would be: "Drug, Device Makers Shrug Off Recession."

Wyeth earned $1.2 billion in the first quarter, virtually the same as a year ago. Glaxo profits were down 14 percent, but that was almost entirely due to a falloff in Avandia sales. Bristol-Myers Squibb saw profits surge 51 percent on a 20 percent increase in sales over a year ago. Boston Scientific beat expectations. AstraZeneca profits were down all of 3.7 percent.

Developing and marketing drugs is a risky business, consumers are constantly told. It takes a billion dollars to bring a new drug to market. Only one in 10,000 molecules make it from the lab to the bedside. That's why they have to charge so much for their products.

But as Stan Finkelstein and Peter Temin write in their new book, "Reasonable Rx," "investing at the drug company level is a good, solid and basically riskless (their emphasis) proposition."

No matter how many times industry analysts warn that a patent expiration is going to make this or that company vanish, it hasn't happened -- at least in the last quarter century. . . A large part of that stability comes from the fact that the industry has figured out how to price its products so companies stay financially healthy."

And, unlike Europe and Japan, there's no one in government to stand in the way. Medicare is prohibited from negotiating lower drug prices, while insurance company co-pays shift more and more of the burden onto consumers, effectively taking them out of the game of negotiating lower drug prices.

Decades ago, investment advisers counseled their clients to shift into consumer non-durable manufacturers like Procter & Gamble to weather a recession. People will always need soap and toothpaste. I suspect these days the word on the Street is to buy drug stocks if you want consistent earnings. Come hell or high water, people will continue taking their meds because there's at least one thing in life that is more precious than cleanliness, and that's health.

McCain on Job Training

So this morning I'm listening to NPR and hear a single soundbite from Sen. John McCain amid all the back-and-forth on the Pennsylvania outcome. It was compelling. He wouldn't promise to bring back the steel mills in Pennsylvania, just like he wouldn't promise to bring back the textile mills in South Carolina (I'm paraphrasing here because I didn't have a pen available to write down the exact quote). But he'd make sure that every displaced worker had access to education and training for the jobs of the future, not the jobs of the past.

So honest. So forward-looking. So, dare we say it, compassionate.

Here's John McCain's record on job training:

* In 2002, McCain voted to kill an amendment requiring the Labor Department to establish a pilot program providing low-interest loans to workers in job training or job assistance programs that would enable displaced workers to continue making their mortgage payments.

* In 2007, McCain said "he would reallocate money spent on existing retraining programs to help pay for his proposal" to create a wage insurance system for laid-off workers, according to the Detroit Free Press.

* In March of this year, McCain skipped a vote on a worker training program, which would specifically "improve the training of manufacturing workers." McCain instead attended a $1,000-a-plate fundraiser in Philadelphia.

In 2000, a Republican candidate running for president told the American people he was a "compassionate conservative" while offering private assurances to religious bigots and economic royalists that he was really one of them. Once in office, it was his private assurances, not his public utterances, that really mattered.

Alas, with the help of the press, it looks like it's going to be "fool me once, fool me every time" from the misnamed "straight talk express." It took me five minutes on the Internet to get the counterfactual from the AFL-CIO and Democratic National Campaign Committee websites (admittedly biased sources, but they referenced the specific votes in Congress). And, anyway, isn't it journalists' jobs to get the other side of fact-based questions, and not rely on campaign-style he said/she said?

Glaxo, the Supplement Maker

GlaxoSmithKline announced late yesterday afternoon that it will acquire Sirtris Pharmaceuticals, the Massachusetts start-up company developing an analog of resveratrol, the chemical in red wine thought to promote longevity by postponing degenerative diseases. To prove this to the Food and Drug Administration's satisfaction, clinical trials involving thousands of people, perhaps even tens of thousands of people, stretching over many years, will have to take place.

Of course, the FDA could abandon its traditional standard and allow Glaxo to market a resveratrol analog as a pricey prescription drug based on lesser studies, which would make it the equivalent of dietary supplement. Since supplements do not have to meet the FDA's scientific standards of efficacy, there are already numerous resveratrol pills on the market. Check out this comment on the Wall Street Journal's Health blog:

According to Wikipedia, Consumer Lab, an independent dietary supplement and over the counter products evaluation organization, published a report on 13 November 2007 on the popular resveratrol supplements. The organization reported that there exists a wide range in quality, dose, and price among the 13 resveratrol products evaluated. The actual amount of resveratrol contained in the different brands range from 2.2mg for Revatrol, which claimed to have 400mg of “Red Wine Grape Complex”, to 500mg for Biotivia.com Transmax, which is consistent with the amount claimed on the product’s label. Prices per 100mg of resveratrol ranged from less than $.30 for products made by Biotivia.com, jarrow, and country life, to a high of $45.27 for the Revatrol brand. None of the products tested were found to have significant levels of heavy metals or other contaminants.

So why would anyone buy this drug? The Glaxo "drug" will be chemically manipulated to be much more potent and more easily absorbed than the natural substance. Is that worth $100 or more a month, the typical price of prescription drugs?

Drug companies are already well down the road to selling drugs that influence biomarkers of disease. LDL cholesterol isn't a disease, but lowering its high concentration in people already at risk of coronary artery disease lowers the incidence of heart attacks and strokes in that population. High blood pressure isn't a disease, but numerous studies have shown that reducing blood pressure correlates with fewer heart attacks and strokes.

Now they're moving into substances that, in their natural form, are good for you. Frankly, I'd rather have a daily glass of red wine. And for $100 a month, I can probably afford better wine than I'm drinking now.

As Longevity Declines in Poor Areas

States Raid Tobacco Settlement Money

Life expectancy is dropping in rural parts of the U.S., a harbinger of what may lie ahead for the rest of the country, according to researchers who published the study in today's issue of PLoS Medicine.

The authors looked at county level data for two broad spans of time: the two decades after the election of John F. Kennedy; and the two decades after the election of Ronald Reagan. Here's what they found (the green areas indicate counties adding life expectancy compared to the national average with dark green being the largest increases; the light orange indicate areas whose life expectancy stayed the same -- which was below the national average, which increased as a whole; and the dark orange indicate areas where life expectancy was falling):

The authors blamed high rates of smoking, rising obesity rates and associated diseases (cancer, chronic obstructive pulmonary disease, Type II diabetes). They also noted that the last two decades of the 20th century marked a period of stagnant wages and rising income inequality, with the hardest hit areas being those left behind what has generally been considered a period of rising prosperity.

The lead author, Christopher Murray, an epidemiologist at the University of Washington, suggested the alarming data called for targeted public health campaigns to combat the physiological causes of declining longevity: smoking, obesity and sedentary lifestyles.

Which brings me to a less reported news item from yesterday: the American Legacy Foundation, which is the national organization that gets money from the 1998 tobacco settlement to run anti-smoking campaigns, will be in court later this week in an effort to stop Ohio from raiding its tobacco settlement trust fund to help balance the state budget. The southern tier of Ohio counties are among those whose life expectancy were either stagnant or declining as its economic fortunes declined.

Most cash-strapped states have already funneled their tobacco settlement money into the general revenue coffers. Only 11 states established trust funds to ensure the money was used for public health. Now Ohio is seeking to become the first to undermine those trusts.

Gov. Ted Strickland (D), who is sometimes mentioned as a potential vice presidential candidate for either potential Democratic nominee, says he needs the money for an economic development program, which, like most such state efforts, is designed to lure business to the state with special incentives. But as Michael Roizen, a nationally known wellness expert at the Cleveland Clinic told an audience at Case Western Reserve University last week, "If you want to do something to help, you write the damn governor and tell him he gets more jobs by keeping the money there and cutting down medical costs so we can afford to have jobs in the state."

So here's what it has come to in the good old U.S.A.: a declining state (sort of like Pennsylvania, where primary voters will be voting today), desperate to attract jobs, takes money away from citizens who are trying to reverse the effects of having no jobs in the first place.

Of course, if the anti-smoking campaign were taking place in Iraq, there'd be plenty of taxpayer money available to do both. On the other hand, when it comes to declining longevity, the Iraqis have a lot more to worry about than their sky-high smoking rates.

JAMA May Penalize Authors Who Hide Corporate Ties

Last week, the Journal of the American Medical Association ran two studies that showed the medical publishing industry has been played like a fiddle by the drug industry. The first revealed that Merck had employed ghost-writers on dozens of published Vioxx studies. A second alleged that a company-funded review of studies involving Alzheimer's and dementia patients had manipulated data to hide the drug’s dangers.

In an accompanying editorial, the editors of JAMA called for steeper penalties on authors who fail to disclose conflicts of interest, hide or manipulate data, or claim to have done work actually done by others. The proposed penalties ranged from requiring public letters of apology to a ban on publishing in the journal.

“When integrity in medical science or practice is impugned or threatened—such as by the influence of industry—patients, clinicians, and researchers are all at risk for harm, and public trust in research is jeopardized,” editor-in-chief Catherine DeAngelis and deputy editor Phil Fontanarosa wrote.

That editorial marks a hardening of attitudes by some journal editors toward repeated failures by scientists to reveal their financial ties to industry. In August 2006, DeAngelis rejected a ban on authors who failed to disclose conflicts of interest, claiming authors would simply seek out other journals. “It cleans our house by messing others,” she wrote then. The shift came just a few weeks after JAMA published corrections involving radiologists who failed to disclose their lung cancer screening study had been funded by the tobacco industry.

Notably absent so far from the debate is the New England Journal of Medicine, which got caught in another scandal last week (it also had not disclosed the tobacco-lung cancer screening connection). This one, revealed in the Wall Street Journal, involved an author of an article claiming tanning improved vitamin D uptake who failed to disclose his ties to the tanning industry trade group.

Portions of this item first appeared in Integrity in Science Watch, a publication of the Center for Science in the Public Interest.

Journalists Slam ABC Debate Tactics

The following open letter was posted on The Nation's website this afternoon. I'm a signatory to the letter:

We, the undersigned, deplore the conduct of ABC's George Stephanopoulos and Charles Gibson at the Democratic Presidential debate on April 16. The debate was a revolting descent into tabloid journalism and a gross disservice to Americans concerned about the great issues facing the nation and the world. This is not the first Democratic or Republican presidential debate to emphasize gotcha questions over real discussion. However, it is, so far, the worst.

For 53 minutes, we heard no question about public policy from either moderator. ABC seemed less interested in provoking serious discussion than in trying to generate cheap shot sound-bites for later rebroadcast. The questions asked by Mr. Stephanopoulos and Mr. Gibson were a disgrace, and the subsequent attempts to justify them by claiming that they reflect citizens' interest are an insult to the intelligence of those citizens and ABC's viewers. Many thousands of those viewers have already written to ABC to express their outrage.

The moderators' occasional later forays into substance were nearly as bad. Mr. Gibson's claim that the government can raise revenues by cutting capital gains tax is grossly at odds with what taxation experts believe. Both candidates tried, repeatedly, to bring debate back to the real problems faced by ordinary Americans. Neither moderator allowed them to do this.

We're at a crucial moment in our country's history, facing war, a terrorism threat, recession, and a range of big domestic challenges. Large majorities of our fellow Americans tell pollsters they're deeply worried about the country's direction. In such a context, journalists moderating a debate--who are, after all, entrusted with free public airwaves--have a particular responsibility to push and engage the candidates in serious debate about these matters. Tough, probing questions on these issues clearly serve the public interest. Demands that candidates make pledges about a future no one can predict or excessive emphasis on tangential "character" issues do not. This applies to candidates of both parties.

Neither Mr. Gibson nor Mr. Stephanopoulos lived up to these responsibilities. In the words of Tom Shales of the Washington Post, Mr. Gibson and Mr. Stephanopoulos turned in "shoddy, despicable performances." As Greg Mitchell of Editor and Publisher describes it, the debate was a "travesty." We hope that the public uproar over ABC's miserable showing will encourage a return to serious journalism in debates between the Democratic and Republican nominees this fall. Anything less would be a betrayal of the basic responsibilities that journalists owe to their public.

Spencer Ackerman, The Washington Independent
Eric Alterman, City University of New York
Dean Baker, The American Prospect Online
Steven Benen, The Carpetbagger Report
Julie Bergman Sender, Balcony Films
Ari Berman, The Nation
Brian Beutler, The Media Consortium
Michael Berube, Crooked Timber, the University of Pennsylvania
Joel Bleifuss, In These Times
Sam Boyd, The American Prospect
Lakshmi Chaudry, In These Times
Joe Conason, Journalist and Author
Brad DeLong, Brad DeLong's Semi-Daily Journal and UC Berkeley
Kevin Drum, The Washington Monthly
Henry Farrell, Crooked Timber, George Washington University
James Galbraith, University of Texas at Austin
Todd Gitlin, Columbia University, TPM Cafe
Merrill Goozner (formerly Chicago Tribune)
Ilan Goldenberg, The National Security Network
Robert Greenwald, Brave New Films
Christopher Hayes, The Nation
Don Hazen, Alternet
Michael Kazin, Georgetown University
Ed Kilgore, The Democratic Strategist
Richard Kim, The Nation
Ezra Klein, The American Prospect
Mark Kleiman, UCLA/The Reality Based Community
Scott McLemee, Inside Higher Ed
Ari Melber, The Nation
Rick Perlstein, Campaign for America's Future
Katha Pollitt, The Nation
David Roberts, Grist
Thomas Schaller, Columnist, The Baltimore Sun
Mark Schmitt, The New America Foundation
Adele Stan, The Media Consortium
Jonathan Stein, Mother Jones Magazine
Mark Thoma, The Economist's View
Michael Tomasky, The Guardian
Cenk Uygur, The Young Turks
Tracy Van Slyke, The Media Consortium
Kai Wright, The Root

Patients Protest Promiscuous Promotion of Off-Label Prescribing

A coalition of consumer groups later today will send a scathing letter to the Food and Drug Administration protesting a proposal to give manufacturers a blank check to promote the off-label use of drugs and devices. The letter, signed by Consumers Union, the Center for Science in the Public Interest, the Government Accountability Project and a half dozen other patient and consumer groups, charges the lenient guidelines will undermine the FDA's authority to regulate off-label marketing and lower incentives for firms to conduct rigorous clinical trials or seek agency approval for the uses to which the drugs are being put.

The guidelines mark a "180-degree reversal of prior practice (by) eliminating Food and Drug Administration review of articles that manufacturers plan to distribute to physicians. As a weak and dangerous alternative, the draft guidance proposes a de minimus self-regulating standard," the letter asserts.

Under the proposal, the only requirements on articles distributed to physicians in their offices by drug industry salesmen is that they come from peer-reviewed journals that have a conflict-of-interest disclosure policy and that they be "well-controlled," which is not defined in the draft guidance. The guidelines would not protect against distribution of ghost-written articles, such as the dozens of studies funded and written by Merck scientists that later appeared in journals under academic physicians' names. Nor would they protect against the mass distribution of so-called seeding studies, which, while peer-reviewed, often are of limited size and do not have statistical significance.

The guidance does not require that the distributed studies reflect the traditional and scientifically valid gold standard of medical research—randomized controlled clinical trials. Despite the best interests of medical research and patient safety, an increasing number of studies that appear in peer-reviewed literature are small in size, without a randomized control arm, or contain an inappropriate control arm (placebo instead of an approved use for that indication). Far too many studies are of limited or even insignificant statistical validity. Indeed, the proliferation of such studies in journals has become so prevalent that one former medical journal editor, Richard Smith of the British Medical Journal, branded medical journals “an extension of the marketing arms of pharmaceutical companies.”

The proposed guidance's conflict-of-interest rule is totally inadequate, the letter noted.

Journal conflict of interest policies are routinely violated by researchers and disclosure offers no protection against ghost-writing by industry paid consultants. Merck had dozens of ghostwritten articles drafted for its infamous pain-reliever Vioxx, according to a recent Journal of the American Medical Association article. Furthermore, what constitutes the weight of credible evidence is itself a contested terrain, with industry underwriting the creation of many evidence reviews and clinical practice guidelines.

"The proposed guidance would allow industry salespersons to distribute literature that industry has largely created under controls that industry has largely underwritten," the letter noted. "The FDA proposed guidance would be in effect a de facto deregulation of the nation’s medical information distribution system that would endanger patient safety."

One in five prescriptions in the U.S. (21 percent) are for uses not approved by the FDA. The majority of these unapproved uses (73 percent) lack any evidence or rigorous studies to support the safety and efficacy for that use, according to the letter.

Historically, the FDA not only reviewed literature distributed by manufacturers to physicians that described off-label use, but limited manufacturers to distributing articles for uses where the companies were at least seeking regulatory approval by running randomized controlled clinical trials -- the gold standard of medical research. The proposed guidance would sharply reduce incentives for manufacturers to complete such trials.

"When manufacturers can market drugs and devices with journal articles, they have an incentive to set up trials with endpoints designed to make their products look good, not meet regulatory standards," the letter stated. "Compared to the FDA approval process, the publication process makes it easier for pharmaceutical and medical device companies to hide information about the shortcomings or risks of their products. Companies will take advantage of the opportunity to delay publication of results they don’t like, as illustrated, for example, by the failure of companies to timely release risk and effectiveness information about Vytorin, Avandia, and Vioxx."

Individuals can issue their own protests before the Monday deadline by going to Regulations.gov and putting the docket number FDA-2008-D-0053 in the search field under the "Comment or Submission" tab. That will take you to “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices,” where you can hit the "submit a comment" button.

The Wall Street Journal ran a story this morning detailing drug companies' push for the proposal. The reporter did not seek a response from any consumer or patient group.

New Health Wonk Review

Want a single place to read about the latest and best of the health care blogosphere? Maggie Mahar of the Health Beat Blog has her excellent take in the latest edition of the Health Wonk Review. Check it out!

Last Night's Debate

I nominate ABC News debate moderators Charles Gibson and George Stephanopoulos for the worst performance by political journalists in a starring role in modern American political history. After 45 minutes of last night's debate, the questions from the alleged journalists had covered bitterness, Rev. Wright, bitterness again, Rev. Wright again, dodging bullets in Kosovo (I guess that passed for equal opportunity bullshit), and then, to top it all off, a question about Sen. Obama's relationship with Bill Ayers, who was a member of a radical fringe group 40 years ago. Then Stephanopoulos, a former Democratic Party apparatchik in the first Clinton administration, bated both candidates to publicly take the "no new taxes" pledge, one year before the Bush administration's massive tax break for the rich (enacted on the eve of war) is about to expire.

Only after the third or fourth commercial break and nearly an hour into the show did the first question come about one of the top three issues on the minds of American voters: Iraq. The economy was passed over quickly to move onto gun control. And unless I missed it while taking a bathroom break, the issue of health care never came up.

I logged onto the ABC News website after the debate and wrote a quick note in their feedback form. I politely informed them that I will never, ever watch ABC News again. Shameful.

FDA Set to Approve Ghost-Writing

All the major newspapers that circulate in the nation's capital (the New York Times, the Wall Street Journal, and the Washington Post) carried stories this morning about a new study in the Journal of the American Medical Association that showed about half of articles that appeared in the medical literature touting Vioxx had been ghost-written by employees or contractors working for Merck, the drug's manufacturer.

What none of those stories or the study mentioned was the regulatory context in which this study (and an accompanying one alleging Merck manipulated the data in one of those studies to hide the mortality risk among Alzheimer's patients who used the drug) appears. The Food and Drug Administration wants to give drug manufacturers like Merck a blank check to distribute to physicians nearly any article advocating off-label use of drugs that appears in the medical literature.

The only substantive criteria in the proposed guidance is that the article be peer-reviewed and reflect "well-controlled" clinical studies. It would abandon the FDA's prior practice of pre-reviewing articles advocating the off-label use of drugs before they could be distributed by industry salesmen. Under this proposal, virtually all of Merck's ghost-written studies could have been distributed. As it was, the company bought nearly a million copies of the seminal study that led to the approval of Vioxx that had appeared in the New England Journal of Medicine.

The draft guidance has already drawn fire from Rep. Henry Waxman (D-CA), and I commented on it in this post, "FDA Proposes Lack-of-Evidence-Based Medicine Policy" when it first came out. Perhaps the best thing that readers of this blog can do at this point is to write to the FDA protesting these proposed guidelines, which you can do by going to the Regulations.gov website, putting in the docket number -- FDA-2008-D-0053 -- and hitting the "submit a comment" button.

Despite a New England Journal of Medicine commentary opposing the guidance last week, there were only 33 comments as of this morning, many of them from industry groups that support liberalizing the reprint policy. A patient and consumer coalition in which I take part plans to file comments before the deadline, which is next Monday. I hope to post those comments in this space later in the week.

You can read the study on ghost-writing here; and the re-analysis of the Merck Alzheimer trial here.

This issues raised by Drs. Bruce Psaty and Richard Kronmal in the Alzheimer's trial are especially disturbing since the company, which ran the trial, did not set up a data safety monitoring committee. Company officials and lawyers quoted in the stories said it wouldn't have made a difference. But Psaty, one of the nation's leading independent biostatisticians, said, "This was a huge safety signal. If this had been made public in a timely fashion, many fewer patients would have used Vioxx, and fewer might have been harmed by it."

The authors conclusions, which go far beyond the ghost-writing issue, are worth pondering:

For sponsors that conduct their own studies or use contract research organizations to conduct studies, it is not clear how transparency in the reporting of results can be achieved if a sponsor chooses to represent its products in the best possible light. The commercialization of clinical trials has neither improved the quality of the science nor enhanced the protection of human research participants.

The findings from this case study suggest that additional protections for human research participants, including new approaches for the conduct, oversight, and reporting of industry-sponsored trials, are necessary. A clinical trials system in which sponsors fund the trials that are conducted by independent investigators would provide additional protections.

Frontline Special: "Sick Around the World"

I had the pleasure of getting to know T.R. Reid of the Washington Post when we were both stationed in Tokyo. Tomorrow night, he presents the first of his series "Sick Around the World" on PBS' Frontline. Check out this trailer, and you'll be sure to watch:

High Biotech Drug Prices = A Failed Industrial Policy

Insurance companies are charging many patients thousands of dollars a month in co-pays for very expensive drugs, the New York Times reported this morning. A quick glance of the list of drugs that the insurance industry funneled onto this so-called "Tier 4" co-pay list are recombinant proteins, products of the nation's biotech industry.

About half of the one dozen drugs highlighted in the graphic accompanying the article are made by Amgen and Genzyme, two of the nation's leading biotech companies. But rather than re-exploring the failures of these biotech industry giants, let's look at Copaxone for multiple sclerosis, which was the drug featured in the lead anecdote in the story and is made by Teva Pharmaceuticals, an Israeli company whose original claim to fame was as a maker of low-cost generics.

From the FDA Orange Book, we learn that the Food and Drug Administration approved this drug in 1996. From the nation's public registry of clinical trials, we learn that the primary approval trial for Copaxone (copolymer 1, a combination of four recombinant proteins) involved about 250 patients with relapsing MS, half of whom were randomized to placebo.

This trial, according to the government, was conducted at the University of Maryland on a National Institutes of Health grant with information provided by the Office of Rare Diseases at the Food and Drug Administration. In other words, taxpayers like you and me paid for the seminal research that brought this drug to market.

According to this website produced by a Brit with MS, we learn that Copaxone reduced the rate of relapses among patients taking the drug by about 29 percent. Subsequent trials, funded by Teva, showed that it was slightly superior or equal to the other drugs for the condition that are on the market (Betaseron by Bayer and Avonex by Biogen, both of which are recombinant forms of interferon). Most of these trials involved just a few hundred patients, and often did not have the statistical power to prove anything in these head-to-head comparisons.

Teva continues to fund research. Again, a quick glance at Clinicaltrials.gov suggests most of these trials compare Copaxone to other drugs for the condition. There are also a few companies seeking to get approval for their own brands of interferon to fight MS, undoubtedly attracted by the high prices set on Copaxone. The government is also still involved. The National Institute of Neurological Diseases and Stroke (NINDS) has financed Dr. Fred Lublin of Mt. Sinai Medical School to test 1,000 patients randomized to either Copaxone, Avonex or placebo. Unfortunately, that trial, which began in 2005, won't be completed until 2012, just two years before Copaxone goes off patent.

Now let's follow the money. A drug company brings a new drug to market based on government-funded research. It charges a huge price for the drug, but since its the insurance companies money, it's everyone's money, which means it's no one's money. So no one complains -- for a while. What does Teva do with the huge cash flow that comes from selling this very expensive drug to a small population of MS sufferers? It funds clinical trials to show it's drug is superior to other in the field, which it shows, sort of. But the trials are never really good enough to prove superiority, just good enough to establish market dominance, which was probably the real goal of the trials. So the government has to sort things out, but it gets back into the game very late and very slowly. The insurance industry, fed up with paying extraordinarily high prices, starts putting the financial onus on patients.

The only justification for the high prices slapped on this government-funded discovery is that it would generate research into new drugs and significant therapeutic insights. Consumers, who paid the tab through their insurance premiums, got neither for their investment. And the government, which could have used that money and much less of it to get started earlier in funding definitive trials, now must come with another huge infusion of cash (a 1,000-person trial will cost at least $10 million) to sort out the mess.

In 1991, when then Secretary of Health and Human Services Louis Sullivan was hauled before Congress to explain why it was paying so much money through the Medicare program for Amgen's Epogen, which is used in dialysis patients, he testified that it was to show Wall Street that this new exciting industry -- biotechnology -- would generate generous returns if it came up with innovative products. Isn't it time to call a halt to this failed industrial policy, especially when it comes to drugs brought to market with taxpayer support? Surely the patients like those now paying 25 percent of the cost these drugs in Tier 4 co-payments deserve better.

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How Not to Run a Comparative Effectiveness Agency

A version of this article first appeared on the Guardian (UK) website.

We live in an age where the answer to many questions is available with the click of a mouse. But when it comes to health care, asking what works best gets a sick person text messages from the Tower of Babel.

If you’re in your 60s and have a slow-growing prostate tumor, should you cut it out, take a drug, stick in a radiating seed, or just watch and wait? Ask a surgeon, a urologist, a radiologist and general practitioner that question, and you might get four very different answers.

As a result, patient care – and cost – varies wildly across the U.S., usually with little difference in outcome and often driven by what local hospitals offer and what physician specialties predominate in an area. Professional medical societies, patient advocacy groups and government agencies publish competing and often conflicting policies to guide clinical practice, while money from companies with a stake in their decisions permeates the entire system, including, all too often, the guidelines offered by the U.S. government.

To cut through the cacophony of competing advice, health care reformers in the U.S. are pushing for a comparative effectiveness agency to provide physicians, patients and insurers with authoritative analyses of what works best in medicine. Much of the oomph behind the push for comparative effectiveness (CE) research is coming from the companies that pay the bills.

And with estimates of waste in the health care system approaching 30 percent (that’s $600 billion annually), who can blame them? It seems like a relatively painless way to convince doctors that they ought to abandon less effective therapeutic approaches that needlessly drive up costs. “Look, here’s what you’ve been doing and its outcomes are not as good as this other (drug, device, procedure, test) that they’re using over here; why don’t you switch to what works best?” an authoritative agency could say. “And if what works best costs less, everyone will be better off.”

Well, not exactly everyone. If your income depends on peddling pricey products and procedures – and that includes many specialist physicians and most drug, biotech, and medical device manufacturers – discovering that an “innovative” new product is no better and maybe even worse than something that is already out there is not in your financial self interest.

Opposition from those groups has usually been enough to kill serious consideration of a CE Agency in the U.S., especially one comparable to the National Institute for Clinical Excellence, which conducts comparative analyses (including cost-benefit analyses) for Great Britain. While NICE has no real power to enforce its findings, it has become the de facto gatekeeper of care standards for the cash-strapped British National Health Service, which must live within government constrained budgets.

But the era where special interests succeed in thwarting the creation of CE agency here appears to be ending. Both Democratic Party candidates have made it a centerpiece of their health care reform strategies. Here's why. Covering all or most of the uninsured without cost controls will add anywhere from $50 billion to $100 billion a year in new health care spending. Under their plans, employers who don’t provide coverage would be subjected to new payroll taxes to cover the uninsured. Unless other costs are controlled, those new taxes would be prohibitively high.

Incorporating CE analyses into coverage decisions would the best way to offset some of those costs, with the savings distributed to everyone who buys insurance. A Commonwealth Fund study released in December estimated the health care system could save $358 billion over ten years by using CE analyses – anywhere from one-third to two-thirds the cost of covering the uninsured.

The movement gained a powerful ally in January when the slow-to-move but prestigious Institute of Medicine issued its own report, “Knowing What Works in Health Care: A Roadmap for the Nation.” It called for a “single entity” to produce “credible, unbiased information about what is known and not known about clinical effectiveness.”

A CE program, the report said, should develop a common standard for evaluating evidence and writing guidelines, and set priorities for conducting its own systematic reviews based on improving health and eliminating “undesirable variation.” It should also consider economic factors, including the cost of treatment.

Unfortunately, when it came to insulating the proposed agency from commercial pressure, the IOM report came up short. The priorities of the CE program should be developed by a committee “chosen to minimize committee bias due to conflicts of interest.” In a separate section on developing clinical practice guidelines, the report called on panels to “include a balance of competing interests and diverse stakeholders, publish conflict of interest disclosures, and prohibit voting by members with material conflicts.”

This is a prescription for paralysis for which disclosure is no cure. If commercial interests have any voice in the design of the studies, the committees' deliberations, or their decisions, it will doom the agency to either issuing innocuous guidelines or risk losing its credibility when affected parties charge bias influenced stronger recommendations.

Powerful forces are already mobilizing to make certain any comparative effective agency established by Congress remains a toothless tiger. When Sen. Max Baucus (D-MT) introduced legislation in March, Pharmaceutical Research and Manufacturers of America vice president Ken Johnson
said the agency should be “structured to promote better patient health and timely patient access to needed therapies, and avoid denying or delaying patients’ access to beneficial care, as what often occurs in Europe and Australia.” The Advanced Medical Technology Association, which represents device makers, insists that “governance of any public-private entity should include representation of all stakeholders.”

This theme was echoed in a recent article in the Journal of the American Medical Association, which likened a potential CE Agency to a Federal Reserve Board for medicine. Its authors – two prominent health care economists and National Institutes of Health bioethicist Ezekiel Emanuel, who also happens to be the brother of a powerful Congressman – also called for putting “stakeholders” on the board and having input into its studies.

This builds what economists call agency capture (when a regulated industry has undue influence over the agency set up to regulate it) into the very structure of the organization. No banks sit on the Fed’s board. And its studies are conducted by researchers who are scrupulously clean of financial ties to the banks they regulate.

It’s one thing to give stakeholders a chance to advice the process – just as they have input through comment and testimony into any regulatory proceeding. But to allow industry representatives to sit on the board, and ask clinicians with conflicts of interest to conduct its studies, would undermine the new agency’s credibility at the start – and doom it to being just another babbling voice in the health care wilderness.

It's Volume, Stupid

The new Dartmouth Atlas of Health features a careful mapping of differences in treatment of elderly Medicare patients with chronic disease in the last two years of life. Why do such patients in Los Angles who wind up UCLA's Cedar-Sinai Hospital cost more than twice as much as patients in Minnesota who wind up at the Mayo Clinic? As I noted in this space a few weeks ago, it's not just prices (and in some cases, it's not prices at all), it's the quantity of services consumed, which, according to the Atlas, is largely driven by the quantity of hospital beds, physicians and other "inputs" available. In health care, it would seem, supply creates its own demand.

Sadly, there was zero attention given to this insightful report in this morning's national press. The best comment I've seen so far came from Rob Cunningham on Health Affairs blog. (That journal is where much of Atlas architect Jack Wennberg's work has appeared over the years). Cunningham pulls from the report the lesson that beefing up primary care is not a magic bullet for holding down costs.

“Simply increasing the number of primary care physicians alone will not improve coordination. Spending on ambulatory visits, many of them to primary care physicians, is positively correlated with (hospital) inpatient days and inpatient physician visits,” Cunningham quotes the authors. “There are no tradeoffs.” Yet the study strongly endorsed the movement toward giving primary care physicians "medical home" responsibilities for coordinating chronic disease care. Cunningham concludes: "Perhaps the next step is to understand how primary care works in low-spending areas."

Anyone seriously interested in health care reform ought to read this year's Atlas, entitled "Tracking the Care of Patients With Severe Chronic Illness." That's what I intend to do over the next few days. That task should be made easier by the fact that Shannon Brownlee of the New America Foundation provided editorial assistance to its authors. She drew heavily from Wennberg and his colleagues' work in her new book, "Overtreated," available from fine bookstores everywhere.

(A personal note: I will be largely offline for the next week due to a death in the family.)

Reform Woes

The New York Times this morning carries the second story in three days cataloguing difficulties in reforming the U.S. health care system. Today's story reports on an experimental Medicare program that involved private firms running call centers staffed by nurses to encourage elderly patients with chronic disease to stick to their treatment regimens. Unless there is a dramatic change over the next few months, the programs will end up costing Medicare as much as they save, with the possibility that they will even cost more than they save.

What's the companies' solution? Like most private firms involved in managing health care, their solution is to cherry pick the patient population they'd like to serve. According to George B. Bennett, the chief executive of Health Dialog:

He wants Medicare to give the companies more flexibility to manage patients in ways they say have already been proven to work among the employees they cover in commercial plans. Such measures, he said, include giving the insurer a bigger role in selecting the patients, with an eye toward identifying the ones most likely to be helped.

Other experts quoted in the story suggested these call centers are inadequate to the task. They recommend adopting the "medical home" strategy, where primary care physicians are reimbursed directly so they can hire staff to follow-up with their patients and coordinate their care.

It also would help alleviate the primary care shortage, which was chronicled in Saturday's Times in a story that looked at Massachusetts and its experiment with universal coverage (that is still far from universal). Hundreds of thousands of newly insured persons are scrambling to find primary care physicians, with many having difficulty. Others report long waits to get their first visit to receive treatments for chronic conditions that have gone unaddressed due to lack of insurance.

One statement in that story struck me as quite off the mark. "Whether there is a national shortage of primary care providers is a matter of considerable debate," the story claimed. "Some researchers contend the United States has too many doctors, driving overutilization of the system."

That mischaracterizes the critique. The U.S. doesn't have too many doctors, it has too many specialists -- about 70 percent of the total. In Europe, the ratio is almost exactly reversed -- 70 percent primary care and 30 percent specialists.

Physician payment policy is at the heart of this mismatch. In the U.S., insurers, whether Medicare or the private sector, pays for each individual service provided. Physician pay scales, set by a committee of the American Medical Association, give the highest rewards to specialties like intervention cardiology, radiology and surgeons, and the lowest rewards to primary care docs. Put the two together and you get a powerful economic incentive for young doctors to enter specialty practice and eschew primary care.

A medical home plan that gave primary care docs extra pay for coordinating individual care for patients with chronic diseases (which account for about 70 percent of all health care costs) would begin to redress that imbalance. But, like companies running call centers, it probably wouldn't generate major savings for the system, at least not in the short run.

To squeeze out short-run savings to cover the uninsured, government programs need to develop a strategy to eliminate some of the wasteful use of drugs, procedures and tests that now permeate the system. There's a growing consensus to set up a comparative effectiveness agency in the U.S. to combat that waste. But even this long overdue reform can run off the tracks if it isn't done the right way, an issue I'll address later this week.

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Those Profitable Non-Profit Hospitals

Facts from an eye-opening page one story in the Wall Street Journal this morning on the "surpluses" being generated by "non-profit" hospitals (to look up the IRS 990 forms filed by the non-profit hospital in your area, visit http://www.guidestar.org/):

* No fewer than 25 nonprofit hospitals or hospital systems now earn more than $250 million a year. 77 percent of nonprofit hospitals are in the black compared to 61 percent of for-profit hospitals.

* Ascension Health, a Catholic nonprofit system that runs 65 hospitals, mostly in the Midwest and Northeast, reported net income of $1.2 billion in its fiscal year ended June 30, 2007, and cash and investments of $7.4 billion. That's more cash than Walt Disney Co. has.

* In 2006, Northwestern Memorial on Chicago's Gold Coast spent $20.8 million on charity care -- less than 2 percent of its revenues. By comparison, the hospitals run by Cook County, where Northwestern Memorial is located, spent 14 percent of revenues on charity car

* At John H. Stroger Jr. Hospital -- formerly known as Cook County Hospital -- 56 percent of patients don't have any insurance when they are admitted. At Northwestern Memorial, the percentage of uninsured patients is less than 5 percent.

* Northwestern Memorial CEO Gary Mecklenberg earned $16.4 million in 2006.

Not His Day

From an article in today's Wall Street Journal on the fate of Newsweek, where over 100 editors and journalists (20 percent of staff) just took buyouts:

At a recent speech at Columbia University, (Newsweek editor Jon) Meacham delivered a blistering response after he asked who reads Newsweek and none of the 100-odd students in attendance raised their hands.

"It's an incredible frustration that I've got some of the most decent, hard-working, honest, passionate, straight-shooting, non-ideological people who just want to tell the damn truth, and how to get this past this image that we're just middlebrow, you know, a magazine that your grandparents get, or something, that's the challenge," Mr. Meacham said. "And I just don't know how to do it, so if you've got any ideas, tell me."

NEJM Confirms Tobacco Industry Funded Study

The New England Journal of Medicine in this morning's edition printed a correction from Drs. Claudia Henschke and David Yankelevitz of Weill-Cornell Medical School that admitted the tobacco giant Liggett & Myers funded their study claiming routine CT scans for smokers can cure 80 percent of lung cancer cases. The original article appeared in NEJM in October 2006 without that information.

In an accompanying editorial, the editors ask authors to reveal who funded their research (the industry funding in this case had been laundered through a non-profit beguilingly named the Foundation for Lung Cancer: Early Detection, Prevention and Treatment.

"As medical journal editors, we believe that it is important that the ultimate source of funding be made clear to the Journal's readers. Second, it is appropriate to ask whether a study on clinical outcomes in lung cancer should be directly underwritten in part by the tobacco industry. Given the enormous burden of smoking-related illness and the ongoing sale of cigarettes and other forms of tobacco, one might question the advisability of research entities accepting funding from tobacco companies except through the American Legacy Foundation, which distributes funds received through the Master Settlement Agreement with U.S. tobacco companies.

"We believe that it is important for our readers and the entire biomedical community to be aware of this situation. Our goal is that readers be fully informed about funding sources. It is the responsibility of authors to disclose fully and appropriately the sources of funding of their studies. We expect that authors will be particularly attentive to transparency in reporting if a funding entity has a vested interest in the outcome. The public's trust in biomedical research depends on it."

Unfortunately, the editors made no mention of another correction from the same article that was also printed in the NEJM this morning. The correction stated that the Henschke-Yankelevitz article should have disclosed their patent on a technique for reading films from CT lung scans, which is held by their university and generates royalties from General Electric.

A few weeks ago, the editors told the Center for Science in the Public Interest and the Cancer Letter that the patent wasn't "relevant" to the original research article and therefore needn't be disclosed. Are they now saying that a patent must be generating royalties before it becomes relevant? Isn't it possible that a scientist holding a patent might want to get something published in the literature that would make some company interested in licensing that patent? Isn't that a conflict of interest that should be disclosed? The editorial's conspicuous silence on this point is disturbing.

Health Wonk Review -- April 3, 2008

The latest survey of the "best of the web" on health care commentary has been posted on The Health Care Blog. Check it out, as well as the site, where industry consultant Matthew Holt and Brian Klepper provide insightful commentary on health care industry trends.

Physicians for 'National Insurance' -- Survey

The most interesting aspect of the new physician survey published in today's Annals of Internal Medicine is the trend. It shows broad support (59 percent) for a national health insurance plan where five years ago, only slightly less than half of physicians surveyed backed national health insurance. Fully 28 percent strongly support a single plan, while 31 percent generally support it. Outright opposition shrank from 40 percent to 32 percent.

Who were those opponents? Specialty surgeons, anesthesiologists and radiologists -- the highest paid physicians in the nation -- were the only sub-groups where a majority of respondents opposed national health insurance. Psychiatrists, pediatricians and emergency room docs were the strongest supporters, with shrinks clocking in at a whopping 85 percent support rate.

Overall opposition fell to 25 percent when physicians were asked if they supported incremental reform, such as both Democratic Party candidates are proposing. Curiously, support fell, too, to 55 percent.

Take away? There may not be much political upside to eliminating single-payer from the dialogue, at least as far as most physicians are concerned. (Does "national health insurance" translate into "single-payer" in most physicians' minds? I'm curious what the numbers would be if they used that term instead). Anyway, those that are against reform -- the well-paid specialists who tend to dominate the debate -- are just as opposed to incrementalism as they are to a single national plan.

Never forget that groups like the American Medical Association opposed Medicare and the first employer-provided health insurance plans, too. Like the child of a difficult pregnancy, the best organized docs -- these days, those are the high-paid specialists -- have always been pulled crying and kicking into the future.

Celebrex Increases Heart Attack Risk, Too

With all the attention at yesterday's American College of Cardiology meeting in Chicago focused on the Merck/Schering-Plough Vytorin fiasco (Sen. Charles Grassley, R-IA, yesterday demanded more documents on the companies' withholding data), reporters largely ignored another damning study on Pfizer's Celebrex.

A pooled analysis of clinical trials of the last Cox-2 inhibitor on the market showed that patients already at risk of heart disease who take high doses of Celebrex tripled their risk of potentially lethal heart attacks and strokes. Even at the more common dose of 200 milligrams twice a day for chronic arthritis pain, the risk nearly doubled, from 6.9 events among 1,000 patients not taking the drug over the course of a year to 10.8 events for every 1,000 patients taking the drug for a year.

The statistical meta-analysis, conducted on a National Cancer Institute grant by researchers led by Scott D. Solomon of the Harvard Medical School, suffered from the trials it had to work with: all the trials used a placebo as the comparison and used fairly high doses of Celebrex. Had it used a drug like naproxen (sold over-the-counter as Aleve or Naprocyn) as the comparator, the results might have been similar to the Vioxx-naproxen trial that doomed that drug. And the high doses used in the pooled trials allowed Pfizer to dismiss the new analysis as not typical because it exceeds the labeled use, which already carries a black box warning about the heart attack risk at high doses.

But are people prescribed this painkiller heeding the warnings on the label? According to Pfizer's latest Securities and Exchange Commission filings, sales of its anti-arthritis medications rose to $2.9 billion in 2007 from $2.7 the previous year and $2.4 billion in 2005, the first year after the black box warning got slapped on the drug. How could sales of this drug be rising? Between April and July of last year, the company launched a massive direct-to-consumer advertising campaign to "clarify misperceptions among arthritis sufferers." It was so successful, they reprised the campaign starting in November.

On the American Heart Association website, where the trial got major billing, past AHA president Ray Gibbons suggested physicians pay close attention to their patients' underlying cardiovascular risk when considering using the drug. "Patients at the highest risk should be the most cautious," he said.

Yes, but when serious arthritis or back pain hits, or an aging Baby Boomer is about to go out and play 18 holes of golf, they're likely to grab a couple of those 200-milligram pills; and they'll take a few more when they get home. And if they do that repeatedly and they're already at risk of a coronary (overweight? diabetic? got a family history?), this latest analysis suggests they've unwittingly put themselves at much greater risk.