Newer Anti-Cholesterol Drugs Strike Out

The final version of the study that sank Vytorin and Zetia appeared in the New England Journal of Medicine over the weekend after its presentation at the American College of Cardiology conference in Chicago. (You can see a summary of the study here.) The take away lesson for consumers? When new classes of medicine come on the market to treat something for which there is already something available, stick with the older medication as long as it works, especially if it is a generic. That the two drugs generated over $5 billion a year in sales for Merck and Schering-Plough is testimony to the power of marketing, and the poverty of medical and regulatory science.

For a dispassionate review of the issues, or if you still have questions about whether you should be taking these drugs, I suggest you read this analysis by Dr. Harlan Krumholz, which was published yesterday on the Journal Watch website.

Analyzing Hillary Care II From a SP Perspective

I'm a regular reader of Don McCanne's daily postings from Physicians for a National Health Program, the nation's premier advocate for single-payer health insurance. Today, Don analyzes the health insurance thoughts of Sen. Hillary Clinton that appeared a recent New York Times interview (to get on his mailing list, send an email to: quote-of-the-day@mccanne.org):

Q: Let's talk for a minute about the formulation of your plan. I'm interested in how seriously you considered proposing a single payer system and at what point in that discussion did you decide to propose an individual mandate?

MRS. CLINTON: You know, I have thought about this, as you might guess, for 15 years and I never seriously considered a single payer system. Obviously, I listened to arguments about its advantages and disadvantages, and many people who I have a great deal of respect for certainly think that it is the only way to go. But I said, as you quoted me, that we had to do what would appeal to and actually coincide with what the body politic will and political coalition building was. So I think if you look at most public opinion surveys, even from groups of people who you would think would be pretty positive towards single payer, Americans have a very skeptical attitude. They don't really know that Medicare is a single payer system. They don't really think about that. They think about these foreign countries that they hear all these stories about, whether they're true or not, which they're often not. And so talking about single payer really is a
conversation ender for most Americans, because then they become very nervous about socialized medicine and all the rest of this. So I never really seriously considered it.

Q: Last question. You talked earlier in the interview about how your plan maintains the private insurance system. But in October, at the forum of the Kaiser Family Foundation, you were asked whether your plan to make government insurance, a Medicare-type plan, available to all was a backdoor route to a single payer system, and you said, "What are we afraid of? Let's see where the competition leads us." So is it okay with you if the market ultimately dictates that the U.S. system sort of morphs into a single-payer system? And if so, doesn't that arm the Republicans with exactly what you were talking about, this claim that it's socialized medicine?

MRS. CLINTON: No, because I think what we would be offering would be a Medicare-like system, which is something people are familiar with, and you know whether we would call it Medicare 2.0 or whatever we would call it. And we'd see whether people want that or not. And where it morphs to, I think this whole system will morph. I mean, look at where Medicare started and where it is today. In large measure, some of the problems we have are because of the way it evolved. But I think from my perspective, having this Medicare-like alternative really does answer the desires of people. And there's a significant minority who want quote a single-payer system. It at least gives them the feeling it's not for profit, they're not paying somebody a billion dollars for raising their premiums 200 percent and all the rest of the problems that we face with the for-profit system. You get the costs of overhead and administration down as much as possible. I believe in choice. Let Americans choose and what better way to determine that than letting the market have some competition and you know see where it does lead to.

Q: And if the choice is a single-payer system, that's fine by you?

MRS. CLINTON: You know, I think that would be highly unlikely. I think that, you know, there's too many bells and whistles that Americans want that would not be available in kind of a bare-bones Medicare-like system but I think it's important to have that competition.

Comment: Competition between a bare-bones Medicare-like plan versus private
bells-and-whistles insurance? What kind of framing is that!?

In her proposal, is she really advocating for a public Medicare-like option that provides only bare-bones coverage? That's certainly not the model that single payer advocates propose.

Is she suggesting that the private insurance industry will be able to provide us with an insurance product that includes all of the bells and whistles at a premium that is affordable? If such a plan were to be offered it would have a very small market limited to only the wealthiest of us. Insurers typically shun small markets.

It's not like she doesn't understand the numbers. Let's look at what else she said in this interview:

****

MRS. CLINTON: The average family policy cost in America today is $12,000. That is, you know, considerably, you know, that's like 25 percent of the median income in the country, right? So people are paying a lot of money. Now, employers defray a lot of that cost but it comes out of wages so you've got this unfortunate situation where we've had flat wages, declining incomes, rising health care costs, so even though your share of that $12,000 family policy might be say 50 percent, or whatever it would be, you're doubly paying for it because you're also paying for it in lost wages.

Q: You've also said you would cap premiums. But you haven't said where you would cap them.

MRS. CLINTON: You know, I think we could do it somewhere between five and 10 percent of income.

****

Or maybe she doesn't understand the numbers. If she does, she has implied that most of the premium will have to be paid through the tax system.

If we're going to use the tax system anyway, then why waste resources on our fragmented, multi-payer system that falls far short on most of our goals for reform? That would be a terrible misuse of public funds.

What health care financing system would be a better use of public funds? A single payer national health program is specifically designed to provide comprehensive health care for absolutely everyone at a cost that is affordable for each individual, and with an efficiency that would be much more appropriate for a publicly-funded program. That's where we need to go.

Barackonomics

Sen. Barack Obama gave a major speech on Thursday that placed blame for the current economic slowdown squarely on deregulation of the financial sector. The speech drew a negative reaction from New York Times columnist Paul Krugman, who called his policy prescriptions "cautious and relatively orthodox." No matter that the differences between Obama and Sen. Hillary Clinton are almost undetectable to the unaided eye. They've both endorsed the Dodd-Frank bill in Congress that would begin re-regulating the banking sector and lend a helping hand to troubled homeowners facing foreclosure.

More significantly, they would both go farther than Sen. John McCain, the Republican's presumptive nominee, or the Bush administration, which on Monday will unveil its own plan for increased oversight of the investment banking firms that brought us the mortgage crisis. As the Times story that will appear Saturday reports:

While the (Bush) plan could expose Wall Street investment banks and hedge funds to greater scrutiny, it carefully avoids a call for tighter regulation. The plan would not rein in practices that have been implicated in the housing and mortgage meltdown, like packaging risky subprime loans into securities carrying the highest ratings.

For some interesting take's on the Obama's Cooper Union speech, check out American Prospect and Boston Globe columnist Robert Kuttner, who likened him to FDR in his ability to turn a crisis into a "teachable moment":

He connected all the dots -- between the complete dismantling of financial regulation, the declining economic opportunity and security for ordinary people, the current financial meltdown, and the political influence of Wall Street as the driver of these changes. Astounding! I wish I had written the speech. It is this kind of leadership and truth-telling that is the predicate for the shift in public opinion required to produce legislative change. A radical, appropriately nuanced, and deeply public-minded description of what has occurred, the speech was Roosevelt quality: the president as teacher-in-chief. Those who felt that Obama was capable of real growth that will transcend the campaign's early and somewhat feeble domestic policy proposals should feel vindicated.

Economic Policy Institute economist Jared Bernstein has an excellent overview of the details of Obama's proposal and the other candidates' plans here.

SEIU Disavows Lipitor Promotion

The Service International Employees Union issued the following statement in response to the Health Beat Blog article, which was reprinted on this website.

Recently, a letter appearing to endorse a well-known pharmaceutical was circulated by the International Association of EMTS and Paramedics, an affiliate of the National Association of Government Employees (IAEP/SEIU).

SEIU does not endorse products. The letter was generated by a Local Union staff member unfamiliar with SEIU's policy against any product endorsement. Upon learning of the letter, the Local disavowed a relationship with the product in keeping with the union's policy.

Glad to hear it.

Big Tobacco Behind Lung Cancer Screening Study

The New York Times reports this morning that the tobacco giant Liggett & Myers contributed $3.6 million to a controversial screening study that suggested using routine CT scans to detect lung cancer early could substantially reduce lung cancer deaths in the U.S. The Cancer Letter recently revealed that when the study first appeared in the New England Journal of Medicine in 2006, the study authors, Claudia Henschke and David Yankelevitz of Weill-Cornell Medical College in New York, failed to disclose they had licensed scan-reading patents to General Electric, which would earn them a bundle if millions of smokers began getting annual CT scans. Now, it turns out that the study was also supported by a non-profit called the Foundation for Lung Cancer: Early Detection, Prevention and Treatment, whose board includes Henschke and top officials at Weill-Cornell Medical School. The Vector Group, which is the corporate parent of Liggett & Myers, announced in 2000 that it was giving several million dollars to the foundation.

“You have to ask yourself the question, ‘Why did the tobacco company want to support her research?’ ” Jerome Kassirer, author of "On The Take" told the Times. “They want to show that lung cancer is not so bad as everybody thinks because screening can save people; and that’s outrageous.”

Near the end of the story, Times reporter Gardiner Harris interviewed Murray Kopelow, chief executive of the Accreditation Council for Continuing Medical Education (ACCME), who revealed that numerous doctors and institutions are setting up foundations to accept money from companies without having to disclose its source.

Physicians who read the original article in NEJM could obtain continuing medical education (CME) credit by answering a few questions online. The ACCME accredits CME providers like NEJM. ACCME rules state that all presenters must disclose financial conflicts of interest during a CME activity. It can revoke accreditation for failing to follow the rules. The NEJM, in a written response to the Cancer Letter and the Center for Science in the Public Interest, which filed an official complaint with ACCME, is claiming that Henschke's and Yankelevitz' patents on how to read CT scans to detect lung cancer were not relevant to the study that appeared in the journal in 2006. The Journal of the American Medical Association, in a corrected conflict-of-interest disclosure on another Henschke article posted earlier this week on the JAMA website, recognized that the patent was relevant.

I wonder if the NEJM editors will now say the same thing about the non-disclosure disclosure in the study that showed it had been supported by the Foundation for Lung Cancer: Early Detection, Prevention and Treatment, but gave no indication as to who stood behind that big tobacco front group.

The Social Determinants of Ill-Health

This morning, let's consider the case of Fay Derricote, an obese, 44-year-old former government contract worker confined to a wheelchair with multiple sclerosis. For the first time in her life, she has good health insurance -- provided by Medicare because she is disabled.

That's precisely what her former employer, the food service firm that ran a government cafeteria in the nation's capital, didn't provide her while she was working, according to this morning's Wall Street Journal. "How Government Adds To Ranks of Uninsured: Many Outsourced Federal Jobs Don't Offer Health Insurance," the headline read.

Sadly, the story's focus on a federal subcontractor contributes to the unenlightened anti-government bias that muddies public debate in this country. How is government outsourcing of jobs to contract firms that fail to provide health insurance any different than the Fortune 500 firms that do the same thing? The 47 million uninsured Americans -- most of whom work for a living -- aren't all employed by government subcontractors. The reporter could just as easily have made the same point using the janitorial services that clean the privately-owned office buildings that house Washington's thousands of private sector lobbyists.

Still, every element of Derricote's case sheds light on the health insurance debate. Unlike most private sector subcontractors, the law requires government subcontractors to make a payment in lieu of insurance so workers can buy their own policies. In her case, that would have come to an extra $3.16 an hour on top of the $7 an hour she earned as a cashier. But a loophole in the law exempts employers in industries that don't typically provide insurance.

Now she has wonderful insurance, courtesy of the very same government that didn't require her employer to insure her. Had she been treated two years earlier, according to her doctor, he might have been able to slow the progression of her disease and gotten her back in the workforce.

It's outrageous, of course, that her lack of insurance delayed care and contributed to the growing disparities in health that, according to this new chart book from the Commonwealth Fund, have worsened in recent years. If we're going to have an employer-based system of providing health insurance in the U.S., doesn't it make sense to require all jobs either provide that benefit or pay into a government fund that becomes the default insurer (the Democratic approach)?

The idea of putting money in people's paycheck so they can buy insurance as individuals or families (the Republican approach) makes no sense for low-income people like Derricote. As the story pointed out, when employers use that approach, most low-wage workers use the money to pay rent, buy food or meet other day-to-day necessities. What would you do if you earned $14,500 a year?

But the story, and the debate over health insurance that marks the two sides in the presidential campaign, did not address the most significant element in her story. What were the social factors that led this relatively young woman to balloon to 289 pounds before a doctor at her place of employment -- the Department of Health and Human Services! -- warned her to go on a diet before she got really sick. His mere warning led her to lose 55 pounds, but it was too late.

Would adequate health insurance have prevented her weight gain? Would the policy have paid for counseling? Would insurance have relieved the stress and time pressures in a life lived earning $7 an hour that contributes to poor dietary habits? Would it have made a dinner that included unsubsidized fish and broccoli less expensive than a trip to McDonald's, where the costs of the red meat, bread, and sugar are kept artificially low through farm subsidy programs? Would it have made her a more informed consumer by putting calorie counts on the menu choices at restaurants or the cafeteria where she worked, where she presumably ate at least one meal a day? Would it have required her employer to give her time during the day to visit the gym, or money to pay for a membership?

Insurance is an important starting point for the national discussion about health. Access to health care is crucial. But unless the nation simultaneously grapples with what are the underlying causes of ill-health in this society, it will never get health care costs under control.

The who and why of the modern day plagues of obesity, high blood pressure, smoking and alcoholism are the undiscussed elephants in the room. These disease precursors are the primary causes of heart disease, diabetes, and most cancers, and their prevalence is closely correlated with inequality, poverty, race, and stress. The chronic diseases that result from these conditions only affect about 30 percent of the population, but they lead to 70 percent of all health care expenditures in the U.S.

The presidential candidates, and everyone running for Congress this year should watch "Unnatural Causes," which kicks off on Thursday this week on most PBS stations. There's still hope that the national discussion about health insurance can be expanded to include the more important discussion about the social determinants of ill-health, the primary reason why our nation lags behind most other industrialized nations in overall life expectancy.

"Unnatural Causes" on PBS -- Must See Television

Your local PBS station starting Thursday night and running for the next four weeks will air one of the most significant documentaries on health-related issues to come along in a long time. It's called "Unnatural Causes," and was produced by California Newsreel. Here's the blurb from their website:

UNNATURAL CAUSES sounds the alarm about the extent of our alarming socio-economic and racial inequities in health—and searches for their root causes. But those causes are not what we might expect. While we pour more and more money into drugs, dietary supplements and new medical technologies, UNNATURAL CAUSES crisscrosses the country investigating the findings that are shaking up conventional understanding of what really makes us healthy—or sick.

This is a story that implicates us all. We’re spending $2 trillion a year and rising on health care, more than twice per person than the average industrialized nation. Yet American life expectancy ranks 29th in the world, behind Jordan. Infant mortality? Cypress, Slovenia and Malta do better. One third of Americans are obese. Chronic illness now costs American businesses more than $1 trillion a year in lost productivity.

It turns out there’s much more to our health than bad habits, health care or unlucky genes. The social conditions in which we are born, live and work profoundly affect our well-being and longevity.

The four-hour series will be broadcast by PBS beginning March 27, 2008. It has been conceived as part of an ambitious communications and public engagement campaign conducted with leading public health, policy and community-based organizations. The campaign aims to use the series and companion materials to help reframe the national debate over health. It will suggest a new and hopeful approach to tackling health inequities, one that links our individual aspirations for better health not only to medical interventions but to social and economic justice.

It's The Prices and Volume, Stupid

Nearly five years ago, an article in Health Affairs by a group of leading economists sought to explain the wild disparity in health care spending between the U.S. and the rest of the industrialized world. The U.S. has fewer doctors, hospital beds, and nurses per person than other advanced industrial nations, and Americans see their physicians less often.

So what accounted for the fact that the U.S. spends 60 percent more than any other nation on health while obtaining outcomes -- lower life expectancy and higher infant mortality rates, for instance -- that put it in the second tier of the 30 nations in the OECD? The article's conclusion was encapsulated by its title: "It's The Prices Stupid: Why the United States Is So Different From Other Countries."

Yale political scientist Jacob Hacker drew liberally from that paper in his opinion piece in the Washington Post Sunday calling for a sharply expanded government role in providing health insurance. His plan, sponsored by the Economic Policy Institute, sets up a new government insurance program to cover all the uninsured, all Medicaid patients and a hefty slice of those who now get private insurance from their employers since many would opt for the newly expanded public system to escape escalating costs.

His new plan, he claims, will be able to "cover everyone without driving up costs." How?

By getting a better deal on service prices, drugs and by lowering administrative overhead. Earlier in the piece, he quoted a study that claims the major government program already in existence -- Medicare -- has grown at a slower pace than private health care since 1980. Expanding the government's role could do the same for the rest of the health care system and even save $50 billion a year, he asserted. Although Hacker was careful to distinguish between government-provided health insurance (like Medicare) and socialized medicine, where the government actually owns health care facilities, he goes with the flow (a recent poll revealed the power of Republican talking points: a majority of Americans now think Medicare is socialized medicine) and concluded "maybe socialized medicine doesn't sound so bad after all."

Elements of Hacker/Economic Policy Institute plan have been included in both leading Democratic Party candidates' health care proposals. But would it really be able to reap $50 billion a year in savings, which was projected by The Lewin Group in its analysis of the plan? The recent experience of Medicare isn't promising.

While Medicare cost growth has been slower than private insurers if you measure it from 1980, in more recent years the government program has been experiencing either the same or slightly higher growth. Why? The original "It's The Prices Stupid" paper pointed out that lower costs in Europe had been achieved through the "monopsony (single buyer) power allocated by these systems to the payer side," which "reduces the prices paid to providers for health care, thereby transferring wealth from these providers to the rest of society."

But if your public plan is part of a mixed system where provider groups like organized physicians, hospitals, drug companies, device companies and durable equipment suppliers can collude and can exercise considerable political clout to avoid price controls, it's hard to imagine achieving the same kind of purchasing power efficiencies here. Look at what is happening in drugs, where numerous best-selling drugs are coming off patent and industry's pipeline of new blockbusters has largely come up empty. This should have been an ideal scenario for lowering overall drug spending.

Yet Medicare hasn't been able to capitalize. The law that created the senior citizen drug benefit specifically forbade Medicare from negotiating lower prices. And in the wake of that decision, Big Pharma has been able to offset its losses to generics by raising prices on its remaining blockbusters. A recent survey by the AARP showed that the prices of the top brand drugs rose 7.4 percent last year. Bottom line: despite the shift to generics, overall drug spending held steady, according to a separate survey by IMS Health.

Meanwhile, the biotech industry has provided the playbook for the next generation of price-gouging, which is taking place in the emerging "personalized medicine" markets for cancer and rare disease therapeutics: never allow generics on the market. The Biotechnology Industry Organization has tied up Congress by arguing that any generic biologic is really a distinct molecule and must, therefore, go through virtually all the same safety and efficacy testing as the original molecule. If Congress goes along (if it ever even gets around to passing a bill), the follow-on biologic will have to be priced like a me-too drug. Consumers may see a 10 percent reduction in price, but not the 40 or 50 percent reduction typical of true generics.

Think what such a law would mean for the 5,000 or so Gaucher's disease patients on Genzyme's Cerezyme, whose travails in trying to hold down their $300,000-per-year costs were documented last week by Andrew Pollack of the New York Times. As a Times editorial on Sunday pointed out, that price tag is "hard to take, given that the federal government did much of the scientific work that led to development of the drug and provided contract money that got the company started." (For that whole story, see chapter two of "The $800 Million Pill" by yours truly).

The same thing is going on for the newer anti-cancer drugs, many of which are biologics. The Wall Street Journal last week had an interesting story on the steps insurers are taking to rein in sky-high costs of these new drugs, many of which are only marginally effective (like most anti-cancer drugs). Still, their makers aren't shy about charging $10,000 a month or more in the name of making up for their high research and development costs. It's an argument that Congress buys time after time, aided by hefty campaign contributions, which, as we commented on earlier this month, are now flowing as easily to the Democrats as they did to Republicans when they controlled both chambers.

It's one thing to editorialize, as the Times did Sunday, that "it would be wise to foster generic competition for biological drugs and allow government programs to negotiate for lower prices on drugs with no competitors." It's quite another, given the current political make-up in Washington, to actually achieve it.

But if a Democrat committed to health care reform actually took the White House this fall and enacted something like the Hacker plan, would this expanded government insurance program be able to bargain its way to lower prices? Exercising monopsony power to hold down costs will require redefining what constitutes quality care in the U.S., and that will require changing the way medicine is practiced, much of which is organized around enhancing physician income. Drugs, which account for about 15 percent of total health care spending, are just the tip of the iceberg.

Last fall, the Congressional Research Service published a sobering comparison of U.S. health care spending patterns to the other 29 nations in the Organization for Economic Cooperation and Development (OECD). Did you know that our physicians order 587 coronary artery bypass graft surgeries per 100,000 population compared to an OECD average of 352? (The next highest country after the U.S. was Germany with 357, barely above the average.) Did you know that we have 32 CT scanning machines and 27 MRI machines per one million population compared to an OECD average of 18.8 and 8.8, respectively?

More procedures and more tests equals more fees in our fee-for-service system. Average physician income in the U.S. (after adjusting for differences in the wealth of the underlying economy) was $50,000 a year greater than the OECD average for specialists in 2004 and $30,000 a year higher for general practitioners. Even if you adjust once more for the higher debt that American medical students must take on to get their education (the CRS estimated that at $7,000 to $18,000 a year in debt service depending on whether the physicians take ten or 30 years to pay off their loans), physicians here still earn a hefty premium over their European or Japanese colleagues.

The point is that coming up with $50 billion a year in savings, as estimated by the Lewin Group, isn't just about negotiating a better deal with the drug companies. It's about reining in needless procedures (hospitals as well as the doctors would take the hit there) and reducing the number of questionable tests (durable equipment suppliers would take the hit there), both of which reduce the volume of physician services and, hence, their income.

It's time to amend the title of that long ago Health Affairs article. It's the prices and volume, stupid.

Health Wonk Review -- the latest

Read the best of the health care blogosphere, this week on Joe Paduda's Managed Care Matters.

Ben Bernanke and Moral Hazard

In case you hadn't noticed, Congress stlil hasn't passed legislation that would stem the tide of home foreclosures sweeping through some low- and moderate-income neighborhoods. What's holding them up? It's the moral hazard question. If taxpayers bail out homeowners who were tricked into taking out teaser-rate loans and now face foreclosure, it may also inadvertently bail out speculators who bought homes hoping to flip them in ever-rising markets, not to mention the people who can't afford the homes they bought under any circumstances.

But what if you're Bear Stearns and the Federal Reserve Board rushes in to avert panic? Here's an entertaining column by Los Angeles Times columnist Joel Stein that puts that bailout in its proper perspective:

nobody besides the Fed is panicking. People are bummed because their houses are worth less, but people were bummed because their tech stocks were worth less, their alpacas were worth less and their Ugg boots were worth less. But your average American isn't freaking out. A CNN poll this week showed that people's main economic fear is inflation -- which is what you get when you print a lot of money, like the Fed is essentially doing by giving so much away. It makes money fun to borrow and not worth saving, which is how the trouble started in the first place. Plus, it makes the dollar fall, allowing Canadians to make fun of us.

Now there's a fate worse than death: inflation and Canadians laughing at us. Sounds like Bernanke's prescription for the overall economy is to make it more like the health care economy. Heaven help us.

Who's Behind Obama Passport Info Leak?

The Dirt Diggers Digest blog by former reporter Phil Mattera has some interesting speculation. Hint: the owner of the outside contractor that does substantial security work for the State Department has made significant campaign contributions to Sen. Joe Lieberman (D-CN), who is recent days has been traveling with Republican presidential candidate John McCain.

McCain's Religion Problem

Rev. Rod Parsley of the World Harvest (mega-)Church in Columbus preaches before 5,200 Pentecostal parishioners and a large weekly television audience. A week before the hotly contested Ohio primary, he endorsed John McCain over Mike Huckabee, the favorite with most of his parishioners. Parsley called McCain the "true conservative" in the race.

According to a new article by David Corn of Mother Jones magazine, Parsley has called 9/11 a wake-up call to all Christians to wage "war" against the "false religion" of Islam with the aim of destroying it.

McCain appeared at a campaign rally in Cincinnati with Parsley a week before the primary. Corn doesn't report what was said at the rally, but here is an excerpt from Parsley's 2005 book, "Silent No More":

"I cannot tell you how important it is that we understand the true nature of Islam, that we see it for what it really is. In fact, I will tell you this: I do not believe our country can truly fulfill its divine purpose until we understand our historical conflict with Islam. I know that this statement sounds extreme, but I do not shrink from its implications. The fact is that America was founded, in part, with the intention of seeing this false religion destroyed, and I believe September 11, 2001, was a generational call to arms that we can no longer ignore.

Will McCain denounce Parsley and what he stands for? I use as my text this morning a column by Charles Krauthammer, headlined in the Washington Post: "The Speech: A Brilliant Fraud." Referring to Sen. Barack Obama's comparison of his grandmother's private fears about black men while walking the streets to Rev. Jeremiah Wright's angry denunciations of white America from the pulpit, Krauthammer asks, "Does he not see the moral difference between the occasional private expression of the prejudices of one's time and the use of a public stage to spread racial lies and race hatred?" He called Obama's speech and his failure to leave his church "an elegantly crafted, brilliantly sophistic justification of that scandalous dereliction."

When will McCain, who asks us to endlessly stay the course in Iraq and threatens to "bomb, bomb, bomb, bombomba Iran," offer America a detailed explication of his views on Islam so that we can watch them on YouTube (I'll certainly reproduce it here). And, if he doesn't, or asks Americans to understand the anger about 9/11 that informs the wild ravings of a so-called man of God like Parsley, how long will it take before Krauthammer and his ilk call it a scandalous dereliction of duty?

Pfizer, SEIU and the "Cholesterol Con"

I heard about this a few days ago, but couldn't pursue it because I was tied up. So I'm reprinting the Health Beat Blog's story, by Maggie Mahar of the Century Foundation:

A couple of weeks ago Dr. Alicia Fernandez, an associate professor of clinical medicine at UC San Francisco, received a very unusual letter from The International Association of EMTS and Paramedics, an affiliate of The National Association of Government Employees (IAEP/SEIU).

The letter began by noting that Fernandez is part of the union’s approved physician network, and then launched into what can only be described as a shameless sales pitch for Lipitor, Pfizer’s blockbuster cholesterol-lowering drug.

First, the alarming statistics presented in the letter:

1 in 3 adults has some form of CVC (cardio-vascular disease)
About every 26 seconds, an American will suffer a coronary event
Stroke is a leading cause of serious, long-term disability in the United States
Every 45 seconds, someone will suffer a stroke.
Then, the endorsement: “Lipitor is available to our members through their prescription plan. IAEP leadership stands behind LIPITOR as the lipid-lowering agent of choice when it is prescribed by a physician. [my emphasis] This confidence in LIPITOR is based on its proven efficacy and is supported by its vast clinical experience of more than 15 years…"

The letter went on, at length, to praise Lipitor’s benefits and to downplay the drug’s risks. In clinical trials, the letter states, “the most common adverse events were constipation, flatulence, dyspepsia and abdominal pain.” But while other risks may not be as “common” they are certainly worth mentioning. They include memory loss which can look like Alzheimer’s and severe muscle pain.

A few days ago, Fernandez received a second, identical letter. Never before in her professional experience had she received a drug ad from a union.

“I’ve never seen anything like this. I’ve never seen Labor endorse a drug product,” she told me. “This is incredible.” Unfortunately, Fernandez adds, this is not the first time that she has seen a drug company use a progressive organization to promote its product.

In this case, the Lipitor letter is signed by “Matthew Levy,” the director of IAEP. “But this is clearly a joint production between the drug company and the union,” Fernandez notes. “Much of the letter is written in medical language—looks like it is written by Pfizer folks. And at the bottom of the second page of the letter there is a Pfizer copyright: ‘2007 Pfizer Inc. All rights reserved. Filed in USA/December 2007.’ Yet it is written on the IAEP/SEIU letterhead.”

Why would Pfizer need the union’s help in peddling its drug? Lipitor, after all, is the best-selling drug in the world, with sales of almost $13 billion in 2006.

But recently, Lipitor has been attracting some decidedly negative publicity.

As regular HealthBeat readers know, in January Business Week published a cover story that asked “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.

As I wrote at the time, the medical evidence shows that while these drugs can help some people they have been widely overprescribed. “Medical research suggests that only about 40 percent to 50 percent of the 18 million Americans taking statins are likely to benefit,” says Dr. John Abramson, a clinical instructor at Harvard and author of Overdosed America. “The other 8 or 9 million are exposed to the risks that come with taking statins--which can include severe muscle pain, memory loss, sexual dysfunction -- and one study shows increased risk of cancer in the elderly-- but there are no studies to show that the drugs will protect these patients against fatal heart attacks.”

Studies show that stains can help one group, says Abramson: “People under 65 who have already had a heart attack or have diabetes. But even in these very high risk people, about 22 have to be treated for 5 years for one to benefit.”

Congress also has been a casting a cold eye on Lipitor, charging that TV ads which feature Robert Jarvik, inventor of the artificial heart, banging the drum for Lipitor, “emotionally manipulate viewers, and underemphasize the potential side effects of the drug.

This may explain why Pfizer reached out to IAEP for help. But it doesn’t explain why IAEP's national director, Matthew Levy, agreed to put his name to the letter. A half dozen phone calls to IAEP, leaving messages for Levy, IAEP President David Holway, IAEP’s legal department and IAEP’s national communication’s director, Stephanie Zaiser, yielded only a response from Zaiser.

According to Zaiser, IAEP’s national president, Holway, had not known that Levy was sending out such a letter, and that IAEP has since made a policy that the organization does not endorse specific drugs. When I pointed out that letters were sent out as recently as a few days ago—and asked when the new policy was put in place-- she said she didn’t know. When I asked if IAEP had any financial relationship with Pfizer, or had ever taken a contribution from Pfizer, she said she didn’t know. When I asked whether Levy’s signing of such a letter, stating that the “union leadership” backed Lipitor-- without the knowledge of the rest of the union leadership-- had had any repercussions for Levy, she said she didn’t know. When I asked if she could go back and ask Holway those questions, she said “no.” When I asked for Holway’s phone number (which I subsequently found) she said she didn’t have it. When Holway’s assistant contacted him on his cell phone and told him that I was on the line, he said that the communications director had already answered my questions.

I concluded that IAEP really doesn’t want to talk about the Lipitor letter.

What is particularly disturbing, says Dr. Fernandez, is that this is not the first time she has seen a drug maker use a progressive organization for cover. Fernandez, who specializes in disparities in the medical care that people of different races receive, then told me a story about BiDil, a heart failure drug approved by the Food and Drug Administration for the treatment of African-American patients. In this case, the manufacturer persuaded the New England branch of the NAACP to back the drug.

“BiDil is not designed to target heart failure in African Americans. It is not even a new medication; actually it’s a combination of two older, generic medications that have long been approved for use among all patients with heart failure, regardless of race,” Fernandez explained. “NitroMed, the maker of BiDil, initially sought patent protection for this ‘new’ combo pill to market to all patients with heart failure. The FDA denied that request. “

“NitroMed then opted for the next-best strategy,” says Fernandez, “applying for patent protection for treating African-American patients with heart failure. The company argued its case both on the basis of science (the drug's efficacy had clearly been demonstrated in a study that included only African-American heart failure patients) and on the basis of combating racial disparities in health. The FDA agreed to approve the pill, but rather than issuing a broad-based approval (as it routinely does with studies that include only white patients), the agency made the unfortunate, and controversial, choice of limiting the drug's approval to the treatment of heart failure in African Americans.”

In 2007, Fernandez wrote an article about BiDil for the Annals of Internal Medicine. The FDA published a rebuttal. Meanwhile Medicare refused the cover BiDIL and The NAACP's New England branch accused the agency of racism. Sadly, “the venerable civil rights organization has fallen for the same marketing ploy that the FDA did in approving BiDil in the first place, and that could set a dangerous precedent in the struggle to end racial disparities in health,” Fernandez observes. She also notes that the Wall Street Journal reported that NitroMed had made a whopping $1.5 million grant donation to the NAACP.

Fernandez then wrote an Op-ed piece for the San Francisco Chronicle, describing how “NitroMed's strategy has paid off. Its combo pill now has patent protection, allowing the company to increase the price of the ‘new’ medication far above the cost of its two generic components. (BiDil costs about $3,000 a year more than its generic components). What's worse, though, is that the FDA's approval created the misperception of a race-specific drug effect and paved the way for more race-based marketing of pharmaceutical products.

“Marketing to particular groups is a lucrative strategy for many products, from soft drinks to cars,” she continued. “Harnessing the political rhetoric of the moment is not new. Virginia Slims successfully used the rhetoric of feminism to sell cigarettes with the iconic ‘You've come a long way, baby’ ad campaign, while ignoring the harmful effects of tobacco.

“That's what the FDA's approval has done for BiDil. Claiming a race-specific effect not only helped NitroMed gain patent protection, it defined a market niche. The use of civil rights rhetoric for BiDil masks the NitroMed's real goal: selling an expensive ‘new’ pill made from two cheap old ones.

“The issue here is not whether health plans should choose or be forced to cover BiDil, or how much profit NitroMed makes,” Fernandez added. “The issue is that the argument over coverage of BiDil deflects attention from the real issues involved in health disparities.”

“If we want to get at the root causes of disparities in heart disease, we need to look at a number of factors, such as under-use of common, standard therapies in African Americans, as well as inadequate preventive care. We need to pay attention to the complex social problems --most notably poverty and inequality-- that interact with human biology to produce poor health. And finally, we must recognize that eliminating health disparities also requires access to high-quality, affordable health care for all Americans--the important issue that Congress is rightly debating.

“The struggle to end racial disparities in health is too important to allow Congress, the FDA and civil rights organizations, such as the NAACP, to be sidetracked by marketing ploys under the guise of civil rights issues.”

Today, Fernandez added, “I’ve never been on the opposite side of the NAACP. I’ve been a big admirer of the SEIU, an extremely progressive organization. But now these drug companies are going to the good guys for cover.”

This brings me back to my question: Why did IAEP, a division of SEIU, decide to endorse Lipitor at this particular point in time? I’m still hoping that the union will get back to me with an answer to this important question.

Break Up the Rx Industry?

A new book by two Massachusetts Institute of Technology professors is calling for the break-up of the drug industry into separate research and marketing/manufacturing arms to promote both innovation and lower prices. Stan Finkelstein, a physician, and Peter Temin, an economist who has studied the drug industry for decades, in their newly published "Reasonable Rx: Solving the Drug Price Crisis," propose:

. . . dividing drug companies into drug discovery/development firms and drug marketing/distribution firms, just as electric utility firms were separated into generation and distribution companies in the 1990s.

Following the utility model, Finkelstein and Temin propose establishing an independent, public, non-profit Drug Development Corporation (DDC), which would act as an intermediary between the two new industry segments -- just as the electric grid acts as an intermediary between energy generators and distributors.

The DDC also would serve as a mechanism for prioritizing drugs for development, noted Finkelstein.

"It is a two-level program in which scientists and other experts would recommend to decision-makers which kinds of drugs to fund the most. This would insulate development decisions from the political winds," he said.

Finkelstein and Temin's plan would also insulate drug development from the blockbuster mentality, which drives companies to invest in discovering a billion-dollar drug to offset their costs.

An example of the blockbuster mentality is developing a new drug for hypertension, one that varies only slightly from those already on the market, but that can bring in huge profits if aggressively marketed.

The Pediatric Exclusivity Gambit

A little over a decade ago Congress gave drug manufacturers six months extra patent protection if they tested their drugs in children. Kids aren't little adults. Their bodies metabolize drugs differently so dosing isn't necessarily a straight line extrapolation based on weight or body size. And what works in mature bodies doesn't necessarily work in bodies that are still growing or with still developing immune systems. Testing drugs for safety and efficacy is kids in sorely needed.

But there are some obvious flaws in the incentive provided by Congress. Many if not most drugs used in children -- I'm thinking here about antibiotics and anti-cancer drugs -- are generic so the carrot of patent extension is irrelevant. And on the other side of the equation, some of the manufacturers who conduct the kid trials are more interested in getting another few billion in sales out of their blockbuster drugs, which usually don't have much use in youngsters anyway (Nexium, an acid reflux disease drug, and Celebrex, a minor painkiller, are typical of this genre).

The Food and Drug Administration has to issue a written request for the study, but manufacturers can amend the request and they often do. Not surprisingly, the results that come back are less than optimal. Of the 140 drugs granted additional patent life in the first ten years of the law, only 25 resulted in new or changed dosing labels and only 35 came up with new or enhanced safety data, and there may have been overlap between those two groups. Clearly, the protocols in the many of the trials being submitted by the manufacturers were inadequate for generating meaningful data.

To be fair, there's huge problems with conducting clinical trials in kids. What parent would give informed consent for their sick kid to participate in a clinical trial where the kid might get a placebo?

So at a meeting of the FDA's Pharmaceutical Science and Clinical Pharmacology committee (full disclosure: I'm a member), the FDA presented a model for using data from adult trials to design better kid trials. The hypothetical example given was for a blood pressure control medication. The committee gave its unanimous approval for the FDA to use such models in negotiating better trial protocols with the manufacturers when they seek additional exclusivity for their patented drugs.

I agreed that such modeling was better than nothing. But as the meeting wound down, I couldn't stop myself from complaining to the FDA about the mismatch between the rewards for manufacturers and the paucity of data generated by the trials. Why not ask companies to conduct two-arm comparative trials, I asked. One arm would be their on-patent drug and the other could be a generic. It would solve the kids-on-placebo problem. It could generate dosing and efficacy information for two drugs for the price of one. And, if properly designed, it might even let physicians know which of the two drugs was more effective in children.

Was there anything in the law that prevented the FDA from requesting such a trial from the manufacturers, I asked. No, the FDA staffers in attendance said.

Given the amount of health care dollars being poured into drug companies through this additional exclusivity, it seems like the least we can ask for. And if companies come in half way through the pediatric trials and ask for an amendment to their protocols, as has frequently happened in the past, the FDA should remember that they can say no to that, too.

Obama' speech

I spent the day in a Food and Drug Administration advisory committee meeting, and thought when I got home tonight that I would use my late night blogging time to comment on one of the issues discussed there today. But a friend sent me the YouTube video of Barack Obama's speech delivered in Pennsylvania earlier today. I found his call to the American people to "move beyond some of our old racial wounds" to work together solve our pressing problems truly inspiring. I think you will too.

The Shame of CME -- Part II

A few weeks ago, the Journal of the American Medical Association carried an excellent overview of industry influence in continuing medical education, which I wrote about here.

This past weekend's edition of The Cancer Letter (subscription required) carried the latest scandal to hit the field. Last year, that muckraking publication revealed that a prominent lung cancer researcher, in an article that appeared in the prestigious New England Journal of Medicine, had failed to disclose a number of granted and pending patents, including one licensed to General Electric, that involved interpreting CT scans in lung cancer patients. The article, which received widespread coverage in the mainstream media, claimed that using CT scans could dramatically increase the number of people who survive a diagnosis of the disease. I wrote about the specious claims in that article here.

Sound like the patent was relevant to the subject being discussed in the article? Well, last month, after receiving a complaint from a public interst group and an inquiry from The Cancer Letter, the NEJM editors deemed the patents “not relevant” and refused to print a correction.

Now, a follow-up investigation by the publication has uncovered numerous instances when Weill Medical College researcher Claudia Henschke failed to disclose the patents in a series of continuing medical education (CME) seminars, including one held by the Radiological Society of North America (RSNA) a month after the article appeared in October 2006. The NEJM article could also be read for CME credit.

The Accreditation Council for Continuing Medical Education in 2005 adopted strict rules for disclosing granted and pending patents held by any presenter at a CME activity. As Murray Kopelow, the chief executive of ACCME, told The Cancer Letter, "royalties by themselves establish the financial relationship of the person with a commercial interest and create the potential for conflict of interest. Therefore, the relationship is relevant in CME.”

The Center for Science in the Public Interest later this week will ask the ACCME to order all the CME providers where Henschke failed to disclose to send proper disclosures to anyone who participated in those activities. Meanwhlie, Sen. Charles Grassley (R-IA) says he plans to launch a Congressional inquiry into physician patenting activity. “It’s becoming clear that patents and royal payments to doctors deserve a lot more scrutiny from Congress, the FDA, professional journals and other watchdogs,” Grassley said.

Curbing Conflicts of Interest in Medicine

In my role as director of the Integrity in Science project at the Center for Science in the Public Interest, I gave testimony yesterday before an Institute of Medicine committee considering how best to manage conflicts of interest in medicine. Here's my initial presentation:

Conflicts of interest in medicine are widespread, have negative consequences and are poorly regulated. The time has come for the profession to set a higher standard.

There isn’t a corner of modern medicine unaffected by conflicts of interest. Two-thirds of medical research is industry-funded; a third of institutional review board members have ties to industry; drug and device firms’ salespersons shower practitioners with gifts; half of physicians’ continuing medical education is financed by medical suppliers; industry-funded clinicians dominate many clinical practice guideline-writing committees; and doctors with conflicts of interest make up one-fifth to a quarter of government advisory panels.

The medical literature has documented numerous negative consequences associated with this extensive industry involvement with the medical profession. They include suppression of negative research results; delays in publication; failure to report serious adverse events in clinical trials; the slanting of systematic reviews of medical evidence; and a systematic bias in research results that favors the outcome desired by study sponsors.

In a time of rising concern about escalating health care costs, financial conflicts of interest have become a major driver of waste and underperformance within the U.S. health care system. They help create an environment where physicians over-prescribe useful drugs; engage in or fall prey to “disease mongering”; discourage use of cheap generic medicines; over-utilize diagnostic and imaging tests; and engage in self-referrals for procedures and operations. Clinical practice guidelines underwritten by industry have led in some cases to the propagation of unsound advice for practitioners.

And what is the larger purpose of all this industry-medical profession interaction? Beyond sales, the rationale most often given, and the one embedded in the charge to this committee, is that it fosters innovation. Yet innovation in medicine – at least as measured by the number of new drugs and biologics approved by the FDA – has fallen fairly steadily over the past decade, a time marked by a growing financial interaction between these two ostensibly independent spheres.

One hypothesis this committee might consider is that excessive financial entanglements between physician-researchers and the private sector is actually harming innovation by channeling scarce scientific resources into medically insignificant research endeavors; inhibiting scientific collaboration; fostering a culture of secrecy; and creating an anti-commons effect through the extensive early-stage patenting of basic science insights and research tools.

Given this background, the questions before this panel are crucial to the future of the profession and the health of the American people. Even if one grants that intellectual collaboration with industry is an important activity worth preserving because it fosters innovation, the question remains what principles should govern those arrangements. Jerome Kassirer, in his concluding chapter in “On the Take,” laid out a set of first principles, which I think are sound:

• Financial considerations must never compromise patient care or the safety of human subjects in medical research;
• Physicians’ medical information must be free of bias generated by financial entanglements;
• The profession should work to ensure that commercial influence does not make the cost of care prohibitive; and
• Physicians should aspire to eliminate financial conflicts of interest.

Given the importance of private enterprise in the U.S. innovation system, individual companies will inevitably generate medical evidence through financial support of some basic, much applied, and most clinical science. These companies inevitably use outside researchers, scientists and educators to supplement their internal efforts. Since this interaction is inevitable, it is crucial that industrial support in whatever form be fully disclosed in the academic literature, in regulatory filings, during continuing medical education activities, to physicians and to their patients. These disclosures must be uniform, universal and accessible to the public.

To meet this standard, publishers should adopt a uniform code of conflict of interest disclosure rules and adopt penalties for failure to comply. And the federal government should require private companies register all payments to researchers, physicians, and other health care personnel on a government-run, publicly available database. The National Library of Medicine’s PubMed and the National Institutes of Health should explore adopting rules that will facilitate proper disclosure within abstracted articles and by the government’s extramural grantees.

But generating new technologies and clinical evidence, their approval by regulatory agencies and their reporting in the medical literature, are only the first steps in the process of diffusing new technology and elevating the practice of medicine. And it is here – diffusion – that a line in the sand should be drawn.

The system for:
• Evaluating medical evidence (beyond peer review, where disclosure rules should apply);
• Reviewing the body of evidence in a field;
• Deriving best practices from systematic reviews;
• Writing clinical practice guidelines;
• Conducting and evaluating comparative research; and
• Evaluating evidence for regulatory purposes;
must be entirely free from conflicts of interest.

Continuing medical education must be weaned from its dependence on industry support. It is entirely reasonable to expect physicians to pay for their own continuing medical education at a level sufficient to adequately reimburse the institutions and individuals who specialize in and prepare those activities.

Similarly, the practice of industry sales personnel offering physicians an endless shower of free gifts, meals and other gratuities whose ultimate purpose is fostering sales of specific products must come to an end. Professional codes of conduct should be amended to prohibit these ubiquitous practices.

The bottom line is that the relationship between physicians, whether as evaluators of medical evidence or practitioners in the field, with any firm with a financial stake in the outcome of the evaluation or individual medical decisions, should be the same as the relationship between financial and political journalists and the companies and politicians they cover. Journalists are strictly prohibited from any engagement, financial or otherwise, with the subjects they cover. In the regulatory arena, advice and decisions must be offered by medical scientists whose relationship to regulated firms are the same as officials at the Federal Reserve Board are to regulated banks and financial institutions. Again, none are allowed.

Why should medicine be held to a lower standard than either of these professions? Where there is total financial independence, there can be no questions about objectivity.

EPO Cancer Use Curbed, Not Eliminated

Amgen and J&J dodged a bullet today when the Oncology Drugs Advisory Committee voted 13 to 1 to allow continued but reduced use of red blood cell boosting drugs (EPO) for cancer patients undergoing chemotherapy.

But, the panel voted 9 to 5 against using Aranesp and Procrit in breast and head and neck cancers, where clinical trials have indicated cancer patients face higher risk of seeing their cancers progress if they use the energy-stimulating drugs.

It also voted 11 to 2 against using EPO in cancer patients who are likely to be cured. With 60 percent of cancer patients now living five years beyond diagnosis, that would seem to rule out the lion's share of patients undergoing chemotherapy.

The New York Times also reported that the companies proposed that "the label would say that anemia treatment should not start until a patient’s hemoglobin — the oxygen-carrying component of red blood cells — drop to 10 grams per deciliter of blood. Now physicians often start when hemoglobin drops below 11."

I'm surprised that the companies proposed this. Is it possible that there is more evidence coming that these drugs are causing harm to some cancer patients?

The ball is now in the FDA's court. Let's see if the agency follows through and puts "don't start EPO therapy until patients hit 10 g/dL" on the label. Yesterday, the FDA and the companies sent out a letter warning physicians not to let their patients go over 12 g/dL. Given the recommendation on the lower boundary, perhaps that should be lowered to 11 g/dL.

If they do take such action, it will be the ultimate irony. When the FDA approved EPO for the first time in the late 1980s, the agency set the target for EPO therapy at a hemoglobin level of 10 to 11 g/dL. Sometimes your first instincts are the right ones.

What Will ODAC Do?

The Oncology Drugs Advisory Committee of the Food and Drug Administration is meeting in suburban Washington today to offer its take on whether erythropoietin-stimulating drugs like Amgen's Aranesp and Epogen and Johnson & Johnson's Procrit pose an unacceptable risk to cancer patients. The FDA and the firms sent this change in its warning label to doctors yesterday:

WARNINGS: . . . the results of two additional studies (show) increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of ≥ 12 g/dL.

That level -- 12 g/dL or a hematocrit of 36 -- is well above a safe target level for eliminating the need for blood transfusion in cancer chemotherapy patients. That is about 10 g/dL. For years, both companies have spent lavishly on direct-to-consumer advertising claiming that taking these drugs will keep up your strength during chemotherapy.

Yet those claims are not supported by strong evidence. Indeed, an FDA reviewer at a previous ODAC meeting dismissed these studies as unanalyzable because their instruments -- patient surveys -- were of such low quality.

At the end of the day, it will be interesting to see if the ODAC chooses to elevate patient safety over poorly documented claims that patients feel better with higher red blood cell counts. And if they do, it will be even more interesting to see if the FDA bites the bullet and orders a more restrictive label.

CMS Okays Heart Scan Payments

I suspect there will be a lot more of these decisions over the next nine months as Bush administration appointees hoping to line up their next jobs grant top-of-the-wish-list favors to special interests.

The New York Times website reported Wednesday that the Center for Medicare and Medicaid Services has reversed a proposed policy to cut off paying for heart scans, which can cost $600 or more. The preliminary decision announced last December found no clinical evidence that heart scans identify heart disease any better than other non-invasive procedures, like a stress test. According to the paper:

Medicare’s initial proposal, which would have ended payment for the scans unless the patients were enrolled in studies to determine the technology’s effectiveness, had met with fierce resistance from the doctors who perform these scans and the companies that make the equipment. They strongly defended the use of these scans as an important alternative to traditional angiography.

Alternative to angiography? Patients who were previously sent directly to the cath lab (where the sneak a camera-led catheter through your leg into the blood vessels around the heart to look for blockages) will now get an expensive CT scan before being sent to the cath lab.

Meanwhile, patients who are borderline for catheterization will get the scans, and many of them will also be sent to the cath lab for the invasive procedure. Will the increased identification of these minor blockages and their stenting through catheterization save lives? No one knows. Will it send in many people for catheterization who really didn't need it? Absolutely, since there is always a some proportion of false positives with any imaging test. Yet:

“We found that the evidence is not black and white either way,” said Dr. Barry Straube, the chief medical officer for Medicare. Given the overwhelming criticism of the preliminary decision, the agency decided that it did not have enough reason to override the local carriers’ decision to cover the tests as medically necessary. “Before we make a significant change in policy, we need more evidence,” Dr. Straube said.

Lobbying by docs and equipment makers. Pay first, evidence later. It's the American way.

Big Pharma's Health Care Reform Playbook

The drug industry gets a disproportionate share of attention when it comes to the high cost of medicine. Drugs and biologics, whether prescribed by physicians or administered in clinics and hospitals, account for just 10 to 12 percent of health care expenditures, significantly less than, say, the 15 to 20 percent administrative overhead associated with allowing private firms to sell health insurance (as compared to the 3 to 5 percent overhead associated with the nation's largest single-payer organization, Medicare).

Still, Congress' ability to curb the explosive rise in drug costs is a bellwether of the political prospects for health care reform. Along with eliminating unnecessary payments to insurance firms (like the 12 percent bump they get for selling Medicare Advantage plans), curbing Big Pharma's voracious appetite for selling overpriced and often unnecessary drugs is the low-hanging fruit of cost control.

An article in today's Washington Post reveals just how hard that is going to be. According to the Center for Responsive Politics, Big Pharma lobbying expenditures have tilted sharply in the two years since the Democrats took control of Congress. Democrats, who only received a third of industry lobbying money in 2006, now get fully half, more than at any time since at least 1988.

And it appears to be working. The prospects for legislation allowing Medicare to negotiate with drug companies for lower prices now that we have a prescription drug benefit for seniors? Dead in the water. The Canadian import bill (another major Democratic Party initiative)? Stopped.

And who are the lobbyists newly hired by Big Pharma? Former top aides for House Speaker Nancy Pelosi (D-CA), Senate Finance Committee chair Max Baucus (D-MT), House Ways and Means Committee chairman Charles Rangel (D-NY), and Senate Health Education Labor and Pension Committee chair Ted Kennedy (D-MA).

The Pharmaceutical Research and Manufacturers Association, the industry's main lobbying group, is leaving nothing to chance. It's signed on to lobby in support of issues not germane to the drug industry in the hope that it will curb their new allies' appetites for going after Big Pharma. So PhRMA, headed by former Congressman Billy Tauzin, is now working with AARP on universal health care, the American Lung Association on clean air and the Partnership for a Drug-Free America to curb the use of illegal drugs.

Don't think that the insurance industry, organized medicine, the hospitals, the device manufacturers and all other providers to the health care system aren't paying close attention to the Big Pharma playbook. Universal health care that costs the taxpayers a bundle (or increases everyone else's fees) is one thing. But tying effective cost control to health care reform is quite another.

If the drug industry succeeds in deep-sixing drug pricing reform issues in this Congress, it bodes ill for other, more far-reaching cost control measure in the next -- measures that are crucial to successful health care reform.

An Essay on Medical Waste from Today's NYTimes

Every once in a while, an essay comes along that summarizes in a few hundred words my own thinking on health care as it has evolved over the past few years. Today's New York Times contained such an essay. I reprint it here in full because I think it is must-reading for anyone (and here I include the presidential candidates) seriously grappling with how to hold health care costs in check:

Many Doctors, Many Tests, No Rhyme or Reason

By SANDEEP JAUHAR, M.D.

I recently took care of a 50-year-old man who had been admitted to the hospital short of breath. During his monthlong stay he was seen by a hematologist, an endocrinologist, a kidney specialist, a podiatrist, two cardiologists, a cardiac electrophysiologist, an infectious-diseases specialist, a pulmonologist, an ear-nose-throat specialist, a urologist, a gastroenterologist, a neurologist, a nutritionist, a general surgeon, a thoracic surgeon and a pain specialist.

He underwent 12 procedures, including cardiac catheterization, a pacemaker implant and a bone-marrow biopsy (to work-up chronic anemia).

Despite this wearying schedule, he maintained an upbeat manner, walking the corridors daily with assistance to chat with nurses and physician assistants. When he was discharged, follow-up visits were scheduled for him with seven specialists.

This man’s case, in which expert consultations sprouted with little rhyme, reason or coordination, reinforced a lesson I have learned many times since entering practice: In our health care system, where doctors are paid piecework for their services, if you have a slew of physicians and a willing patient, almost any sort of terrible excess can occur.

Though accurate data is lacking, the overuse of services in health care probably cost hundreds of billions of dollars last year, out of the more than $2 trillion that Americans spent on health.

Are we getting our money’s worth? Not according to the usual measures of public health. The United States ranks 45th in life expectancy, behind Bosnia and Jordan; near last, compared with other developed countries, in infant mortality; and in last place, according to the Commonwealth Fund, a health-care research group, among major industrialized countries in health-care quality, access and efficiency.

And in the United States, regions that spend the most on health care appear to have higher mortality rates than regions that spend the least, perhaps because of increased hospitalization rates that result in more life-threatening errors and infections. It has been estimated that if the entire country spent the same as the lowest spending regions, the Medicare program alone could save about $40 billion a year.

Overutilization is driven by many factors — “defensive” medicine by doctors trying to avoid lawsuits; patients’ demands; a pervading belief among doctors and patients that newer, more expensive technology is better.

The most important factor, however, may be the perverse financial incentives of our current system.

Doctors are usually reimbursed for whatever they bill. As reimbursement rates have declined in recent years, most doctors have adapted by increasing the quantity of services. If you cut the amount of air you take in per breath, the only way to maintain ventilation is to breathe faster.

Overconsultation and overtesting have now become facts of the medical profession. The culture in practice is to grab patients and generate volume. “Medicine has become like everything else,” a doctor told me recently. “Everything moves because of money.”

Consider medical imaging. According to a federal commission, from 1999 to 2004 the growth in the volume of imaging services per Medicare patient far outstripped the growth of all other physician services. In 2004, the cost of imaging services was close to $100 billion, or an average of roughly $350 per person in the United States.

Not long ago, I visited a friend — a cardiologist in his late 30s — at his office on Long Island to ask him about imaging in private practices.

“When I started in practice, I wanted to do the right thing,” he told me matter-of-factly. “A young woman would come in with palpitations. I’d tell her she was fine. But then I realized that she’d just go down the street to another physician and he’d order all the tests anyway: echocardiogram, stress test, Holter monitor — stuff she didn’t really need. Then she’d go around and tell her friends what a great doctor — a thorough doctor — the other cardiologist was.

“I tried to practice ethical medicine, but it didn’t help. It didn’t pay, both from a financial and a reputation standpoint.”

His nuclear imaging camera was in an adjoining “procedure” room. He broke down the monthly costs for me: camera lease, $4,500; treadmill lease, $400; office space, $1,000; technician fee, $1,800; nurse fee, $1,000; and miscellaneous expenses of $200.

“Now say I get on average $850 per nuclear stress test,” he said. “Then I have to do at least 10 stress tests a month just to cover the costs, no profit going into my pocket.”

“So,” I said, “there’s pressure on you to do more than 10 stress tests a month, whether your patients need it or not.”

He shrugged and said, “That is what I have to do to break even.”

Last year, Congress approved steep reductions in Medicare payments for certain imaging services. Deeper cuts will almost certainly be forthcoming. This is good; unnecessary imaging is almost certainly taking place, leading to false-positive results, unnecessary invasive procedures, more complications and so on.

But the problem in medicine today is much larger than imaging. Doctors are doing too much testing and too many procedures, often for the sake of business. And patients, unfortunately, are paying the price.

“The hospital is a great place to be when you are sick,” a hospital executive told me recently. “But I don’t want my mother in here five minutes longer than she needs to be.”

Dr. Sandeep Jauhar is a cardiologist on Long Island and the author of the new memoir “Intern: A Doctor’s Initiation.”

Woodcock to Run CDER, Again

The Food and Drug Administration announced yesterday that deputy commissioner Janet Woodcock will return to her former post as head of the Center for Drug Evaluation and Research.

The Wall Street Journal noted this morning that she will be in charge of recruiting new staff to implement the recently enacted law beefing up the agency's post-market safety surveillance system. Let's hope her heart is in the task. She has been the primary architect within the agency of the Critical Path Initiative, whose mandate -- helping industry emerge from its innovation drought -- was institutionalized in the newly created Reagan-Udall Institute.

Will this new non-profit, chaired by former FDA commissioner Mark McClellan, get off the ground? Rep. Rosa DeLauro, D-CN, is holding up funding after raising questions about industry domination of its board and mission.

One of Woodcock's first tasks will be to reassure Congress that Reagan-Udall isn't just a think tank for implementing industry's wish list for speeding new drugs to market. She could do that by releasing her suggestions for the new non-profit's research priorities. Don't forget that the mission of Reagan-Udall is not just coming up with new tools for speeding new drugs to market, but developing better tools for evaluating the safety of new drugs once they're on the market.

Another Public Health Disaster Caused by Deregulation

Last week, an endoscopy mill in Las Vegas was shuttered by local authorities after learning the clinic's nurses routinely violated basic cleanliness standards by reusing needles and sedative vials. At least six patients who received treatment at the facility came down with acute hepatitis C. Another 40,000 will need testing for hepatitis B, C and HIV infections.

The Las Vegas Sun reported Sunday that the Centers for Disease Control and the Centers for Medicare and Medicaid Services later this week will send in teams of investigators to review all 50 ambulatory surgical centers in the state, where gambling has taken on a whole new meaning.

I first heard about this story last week on a late night radio news broadcast. Local attorneys representing the infected patients alleged that the nurses who were reusing the needles and vials had been trying to save money. Were they instructed to do so by the physicians who owned and operated the facility? Hopefully, the federal investigators will make that a central thrust of their investigation.

If the recent heparin scandal revealed the total breakdown of the Food and Drug Administration's ability to regulate the drug manufacturing process, this latest collapse of basic public health protection reveals a similar collapse of standards at CMS (most of the patients at the clinic were on Medicare). The agency relied on state authorities to police sanitary conditions at CMS-approved facilities in the state, and, as the weekend story pointed out, Nevada has just 25 inspectors to cover its 1,100 medical facilities, including 50 outpatient surgery clinics.

Moreover, there are plans to lop off ten of those to avoid raising fees on the clinic operators. Meanwhile, the lawyer in charge of the state's health department said its job wasn't to penalize facilities, it was merely to license them. It took an order by the city of Las Vegas to shut the clinic down.

Colon-cancer screening and other outpatient procedures have become the biggest money-makers in medicine, with physicians who prescribe these tests often owning the facilities where they take place. They are required by law to tell patients about this conflict of interest, and the patients must sign a release form stating that they have been so informed.

But disclosure doesn't eliminate the profit-driven, cost-cutting culture inside these procedure mills, where specialists now make some of the highest salaries in medicine. In 2004, for instance, gastroenterologists on average nationwide made $369,000 a year compared to just $156,000 for family practice physicians. Other high-paid procedure-driven specialists include invasive cardiologists ($428,000); orthopedic surgeons ($397,000); and radiologists ($407,000).

Federal investigators may be able to temporarily clean up the mess in Nevada. But do they have the manpower to launch similar investigations in all states where they've subcontracted out their oversight responsibilities? And how many of those states' health departments have the same cozy relationship with its physician-run facilities as the one in Nevada?

This public health fiasco isn't about one clinic in Nevada. It reveals the risks we all take by unleashing fee-for-service medicine in a money-driven, deregulated environment.

When Registering Trials Is No Help

The science journals jumped all over the "hidden data from clinical trials" issue this week with editorials or commentaries in the British Medical Journal, Nature, and Science. The trigger was a meta-analysis published in PLoS Medicine suggesting antidepressants in most cases are not much better than placebo.

The authors had to use the Freedom of Information Act to get results of trials they needed to conclude the analysis, and even then were denied crucial studies. The subheads said it all: "Highlights the ongoing problem of how study results may be distorted by failure to make data fully available"; and "Highlights the need for data to be transparent -- and for a mandatory database of all clinical trials."

Congress just passed a law requiring mandatory registration of all clinical trials and the posting of results. But it falls far short of what is necessary. It is not going to solve problems caused by the fact that industry still funds 70 percent of all trials. They get to decide what gets studied and how it gets studied because they foot the bill.

As Science pointed out is its inimitably circumspect way, the new law raises "further issues" that "require examination."

For instance, does the new law protect against a clinical trial not having an appropriate comparator drug instead of just placebo or an inappropriate comparator drug (like a low-dose of a less effective medicine that will no doubt make your newer drug look powerful, indeed)? No, it doesn't.

Does the new law protect against data fraud, like what happened in the Ketek case? No it doesn't.

Does it protect against insufficient informed consent for patients, especially in Phase I clinical trials? No it doesn't. Remember what happened in Great Britain when they tried a brand new biologic for the first time in humans in eight patients simultaneously and wound up killing one and almost killing the rest? Moreover, by not requiring registration of those Phase I safety trials and publishing results, the new law does nothing to warn other companies off dangerous classes of drugs, or unproductive pathways for their increasingly unproductive research-and-development labs.

But the reality is that the anger being expressed now about failure to disclose data in clinical trials should largely become a thing of the past if, and this is the big if, the Food and Drug Administration writes good rules and properly polices the new law. Let's hope that the medical journals and their news sections follow implementation of the new law as closely as they are following the old stories that resulted from the lack of proper registration and posting of results.

Health Wonk Review -- March 6, 2008

The latest Health Wonk Review is posted at Workers Comp Insider. Check it out!

The Shame of CME

Nearly every state in the nation requires physicians take a certain number of continuing medical education courses every year to maintain their licenses. In highly a complex and rapidly changing field like medicine where licensed practitioners are often called on to make life and death decisions, government has an obligation to ensure that the people who make those calls are up to date on the best practices in medicine.

But who supports continuing medical education (CME)? The field, a self-regulated collage of medical schools, medical journals, professional societies and for-profit CME providers, some of which double as drug and device industry communications firms, now gets more than half its $2.4 billion in revenue from industry. And that financial support has turned what was supposed to be a consumer safeguard into a thinly disguised extension of industry marketing practices.

As Robert Steinbrook cautiously pointed out in today's Journal of the American Medical Association (I say cautiously because of the use of the word "may" below):

* Physicians who are invited to speak at industry-supported CME events or to organize them may have extensive financial relationships with companies, and pharmaceutical companies may have paid them to give other presentations;

* There may be overlap between the material presented at promotional events such as dinner lectures and satellite symposia and CME courses;

* Industry sponsorship also may lead to overemphasis on medicines, medical devices, and diagnostic tests, thereby biasing "the overall curriculum of topics," regardless of their importance to improving care.

* Medical education and communication companies may organize and manage meetings, develop written educational materials, provide public relations services, or prepare advertising and marketing campaigns, among other activities; and

* (There may be) financial associations between industry and other CME providers; independence may be difficult.

There's no "may" here. As a Senate investigation, court suits and numerous journalistic investigations have shown, CME is widely used by industry to boost the off-label use of its products even though there are specific rules prohibiting such quid-pro-quo promotion when industry provides financial support for CME classes or other activities.

Neither the federal nor state governments regulate CME. Rather, the educational providers are certified by the non-profit Accreditation Council on Continuing Medical Education (ACCME), which is based in Chicago and whose board is made up of associations representing physicians, hospitals, and a number of medical specialty societies.

In recent years, the ACCME has tightened its rules requiring teachers to disclose conflicts of interest during CME activities and set a 2009 deadline for companies that do marketing work for drug and device companies to spin off their educational units. But these are mere fig leaves on the corruption inherent in industry's takeover of the activity. Over the past decade, industry funding for CME has quadrupled, a period when the profit margins for CME providers went from 5.5 percent to 31 percent.

Steinbrook, a Dartmouth educator affiliated with Veterans Affairs hospital White River Junction, Vermont, began his list of suggested reforms to curb this "very troubling" situation with this suggestion: CME providers could stop taking money from industry, period. "Although eliminating support from pharmaceutical and medical device companies would involve more change than the alternatives, this approach will likely allow the medical profession to control its own continuing education," he writes.

It's the only reform that matters. The public has every reason to expect that a profession whose median income for its lowest-paid specialties is well into six figures pay for its own continuing education and not rely on the backdoor baksheesh of industry support. And to the extent this would be a burden on physicians, Medicare, Medicaid and private insurers can raise their reimbursement rates to pay for it. After all, medical consumers are already paying for this activity through higher prices to the drug and device companies that make the "grants." Why not do so directly and end industry's intermediary role?

If the ACCME can't see its way clear to enact such a rule, then perhaps the time has come for states to act. All it will take is a few large states passing laws disallowing CME credits from industry-supported education activities to put an end to it. Industry's takeover of this crucial component of keeping physicians up to date on the latest in medicine has got to stop because it undermines the notion that evidence and not marketing is driving the care that patients receive.

The Muslim Smear

Last week, Nation columnist Naomi Klein wrote a convincing column calling on Barack Obama to go on the offensive against the internet-spread hate campaign accusing him of being a Muslim. "Use the attacks to begin the very process of global repair that is the most seductive promise of his campaign," she recommended. "He can state clearly that while a liaison with a pharmaceutical lobbyist may be worthy of scandalized exposure, being a Muslim is not."

While she posted her column last Friday, I didn't read it until I got my copy of the magazine in the mail this evening. I had to laugh. Last night, I watched 60 Minutes. It was like he'd read it, too. Here's what Obama told correspondent Steve Croft after he showed a clip of a focus group that included a distressed, laid off paper mill worker who was leaning toward Obama but expressed fears about the "fact" that Obama was a Muslim and didn't know the national anthem (to his credit, Croft immediately told the fellow it was a lie).

These emails are not just offensive to me, somebody who is a devout Christian and has been going to the same church for the last 20 years, but it's also offensive to Muslims because it plays in, obviously, to a certain fear-mongering."

When Clinton was asked about the Muslim lie and the photo of Obama in Somali dress that her campaign had to deny distributing, she at first said she had "no reason to believe it's true." She then expressed empathy for her opponent, having been the target of so many smear campaigns herself.

If Obama wins the two big primaries tomorrow and he and McCain become the presumptive nominees, it will be interesting to see how the Republicans handle the Muslim issue. Will they denounce the rumor-mongerers? Or will they cave in to the Rovian dark side with non-denial denials like having no reason to believe it's true?

Last night, Obama showed that he has nothing to fear from the Muslim card. To the extent it gets played, he showed that he can turn it to his own -- and the nation's -- advantage.

Always Blame Govt. Spending First

A new study on projected health care costs from the Center for Medicare and Medicaid Services actuaries triggered headlines last week: fast-rising expenditures for Medicare and Medicaid will drive health care to nearly 20 percent of the economy by 2017, forcing massive tax increases or bankrupting the government.

The dutiful notetaker Robert Pear of the New York Times repeated that theme this morning in his "analysis" of the two competing Democrat's health care plans. "While Senators Hillary Rodham Clinton and Barack Obama fight over who has the better health plan for the uninsured, they say little about a more immediate challenge that will confront the next administration, whether Democratic or Republican: how to tame the soaring costs of Medicare and Medicaid," is how he led the piece.

Why this fixation on rising government costs for health? Private sector health care costs (insurance premiums plus out-of-pocket costs for consumers) will rise nearly as fast: 82 percent over the next ten years. The only reason public sector programs are projected to rise faster (100 percent over the next decade) is because of the senior citizen drug benefit enacted for Medicare in 2003. Give Medicare the same right to negotiate prices that private insurers have and the difference largely disappears.

To be fair, the news analysis eventually gets around to mentioning that "spending on Medicare and Medicaid tends to increase in tandem with health spending generally." The author even quotes comptroller David M. Walker to that effect. "To rein in the costs of Medicare and Medicaid, (Walker) said, it will be necessary to slow the growth of health costs generally."

When is that going to be the lead, instead of buried in the bottom half of stories that mislead readers into thinking that government health care programs have a problem that is somehow distinct from our out-of-control health care system as a whole?

(Side note: There's good reason to question some of the assumptions in the CMS report that contributed to the slightly slower rise in private sector spending. The actuaries projected individual payments like co-pays and deductibles to rise just 72 percent over the period and "other payments," which refers to private philanthropic support for health care programs, to grow by just 67 percent -- both significantly slower than government spending. That might happen if we get universal coverage. But without serious health care reform, individuals and foundations, it seems to me, are likely to be making relatively higher outlays for health care compared to government and employers, not lower as assumed in this report.)