Policy Prescription for Those Having More Than One

The British Medical Journal (subscription required) this morning has an interesting study evaluating alcohol control measures. It's accompanied by an editorial from Thomas Babor of the University of Connecticut, who points out that higher liquor taxes, shorter liquor store hours, and targeted counseling programs can sharply reduce alcoholism and episodic alcohol abuse, which is the advanced industrial world's most serious drug problem.

The spate of teenage auto-cides in my area associated with underage binge drinking has frightened the hell out of this father of a teenager. I hope the presidential candidates at some point get around to talking about our misplaced war on drugs, and tackle the most serious substance abuse problem in our society.

Heparin: Who's in Charge Here?

The American owner of the Chinese factory that produced the tainted blood thinner heparin cites trade secrets in refusing to tell the New York Times where it got the pig intestines used in making the drug. A reporter visiting the villages that are part of the supply chain reveals a dense network of small workshops, "unregulated and often unsanitary."

The Wall Street Journal reports the Chinese government believes that "checks of pharmaceutical ingredients made in China are ultimately the responsibility of countries that buy them."

Yesterday, Janet Woodcock, deputy director of the Food and Drug Administration, told Rep. Rosa DeLauro (D-CN) on Capitol Hill that the agency doesn't have enough inspectors to monitor all the foreign drugs and drug component chemicals entering the U.S.

Enough said.

Hacker: Mandate Not Mandatory for Health Care Reform

One of the pleasures of traveling on the West Coast is that you get to read the Los Angeles Times in its natural setting. Like all papers, it is reeling from staff cutbacks, but it remains one of the nation's best. This morning, it ran an op-ed by Yale University political economist Jacob Hacker, who worked with the Economic Policy Institute to issue their own health care reform proposal. He has also advised both leading Democratic Party candidates.

In the op-ed, Hacker admonishes Senators Hillary Clinton and Barack Obama to avoid getting bogged down over the mandate issue, which is easily attacked and helped sink the California reform plan. Even though the economist in him is attracted to the idea and he included it in the EPI-Hacker plan, he rightfully describes mandates as non-essential to achieving far-reaching health care reform.

I'm going to be returning to the economics of health care in a few days after I've had a chance to digest a commissioned analysis of the economics of the EPI-Hacker plan by the Lewin Group. I have some real questions. For starters, they claim they can achieve universal coverage at a cost of about $50 billion. But that estimate relies on about an equal level of cutbacks in physician and hospital reimbursements. While realistic in the abstract, is it realistic politically when Congress routinely avoids cutting back physician payments that have already been mandated in law?

There was also a new report out yesterday from the Center for Medicare and Medicaid Services that I need to look over. This morning's press accounts focused on how Medicare and Medicaid may bankrupt the economy by driving health care costs to 20 percent of GDP by 2017. And the Health Affairs blog fed the anti-government program spin with posts from Sen. Jim Cooper (D-TN) and Sen. Paul Ryan (R-WI) fretting about how it will bankrupt the government in the former case and how government spending distorts the marketplace in the latter.

This focus on government spending ignores one crucial fact that blows both blame-game arguments away: Private health care costs (insurance premiums plus individual co-pays and deductibles) are growing just as fast if not faster than government-provided health care. And while this latest projection from CMS sees private sector health care spending growing at a slower rate than government spending at the end of the ten-year period, there's nothing in the numbers yet. Clearly, people who get their health care via employer-provided insurance (and not Medicare, Medicaid or other government programs) are experiencing rapid health cost inflation, too. Why didn't the press accounts and the Health Affairs blogger-Senators point out that private sector spending on health is bankrupting the rest of the economy? Why the double standard?

These one-sided views of possibly one-sided (again, I haven't read it yet) reports obscure the hydra-headed nature of the health care cost inflation problem. And it facilitates the false claim by people who have other agendas that government "control" of health care is somehow the problem.

On Avastin: A Reply

Dr. Paul Bellman, in a response today on this website, seconded my proposal that the government require practicing physicians to register patient outcomes when they use marginally effective drugs like Avastin. I thought the issues he raised were important enough to merit top billing on this site. Also, if you visit the comments to the original article, you'll find out from Art Levin of the Center for Medical Consumers that pediatric cancer physicians through their network have been doing this for years, and have made remarkable progress in fighting many forms of childhood cancer as a result. Thanks, Paul and Art, for writing:

By Dr. Paul Bellman

Use the real clinical experience of real doctors taking care of real patients using a new drug like Avastin to learn how to better treat patients for a difficult to treat disease like metastatic breast cancer? The idea seems quaint and well intentioned but unscientific these days.

The notion that "observational data is not the same as data from a well controlled clinical trial" has been effectively used by drug companies like Genentech and regulatory agencies like the FDA to remove the clinical experience and potential expertise of practicing doctors from the equation of both drug approval and standards of care.

I would argue that the the data from well controlled clinical trials reflects the intent of the trial design and yields results that reflect that intent. Well controlled clinical trials do not intrinsically advance knowledge such as how to best treat difficult to treat patients where many potential factors can impact on clinical outcomes.

The idea that randomized clinical trials are intrinsically better than an observational data base as a way of advancing clinical knowledge needs to be critically examined. What is needed is a strategic approach in which clinical experience and well designed clinical trials feed each other.

I totally agree with the idea to create a treatment registry to track clinical outcomes for patients with difficult to treat diseases. This would bring the doctor and patient back into the knowledge acquisition process ... something very threatening to the narrow interests of drug companies like Genentech and their sponsored physician experts/Key Opinion Leaders who shape clinical practice and clinical research.

Its ironic that the best support for approving Avastin rests on the hope that some doctors will figure out a way to use it in clinical practice that gives better results than the randomized clinical trial.

Something is very "rotten in the state of Denmark" when billions of dollars can be extracted from our beleagured health care system now that the FDA has approved Avastin on ther basis of the results of the randomized clinical trial that showed it delayed progression of breast cancer but didn't extend life.

There needs to be a mechanism requiring drug companies to support and pay for the kind pof treatment registries that would help doctors learn how to best use their drugs to treat their patients. The often Pharma-supported patient centered consumer groups need to start to demand this.

Rx Cos. and the Medical Journals

With the FDA considering a proposal to give drug company salespersons the right to distribute journal articles touting the off-label use of prescription drugs, I was motivated this week to reread this small masterpiece by Richard Smith, the former editor of the British Medical Journal. It's title: "Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies."

But don't take the word of a former medical editor. Industry has long seen their approach to science as an extension of their marketing apparatus, and the latest confirmation of that comes from a new survey done by an industry consulting firm. According to Best Practices LLC, most of the country’s leading pharmaceutical companies see publishing clinical trials results as a marketing tool as well as a method of disseminating scientific information.

The report, “Scientific Publications Strategy: Managing Reputation, Clinical Trial Results, and Commercial Relevance,” surveyed scientific directors at 14 leading pharmaceutical companies including GlaxoSmithKline, Pfizer, Bristol-Myers Squibb, Abbott Laboratories, Amgen, Merck, Genentech and Eli Lilly. Eight of the firms included regional or national marketing managers on teams planning their publications strategy. “Scientific publications are an essential tool for both clinical and commercial purposes, as they are intended to influence the target audience by raising both awareness of the disease and awareness of a company’s product,” the report stated.

Portions of this story first appeared in Integrity in Science Watch, published online by the Center for Science in the Public Interest.

Health Wonk Review - Feb. 21, 2008

Let’s start this week by paying homage to Jack Wennberg of Dartmouth Medical School, whose pioneering research has taught health wonks everywhere that more care doesn’t necessarily mean better care. Maggie Mahar at the Health Beat Blog draws attention to his work in a post entitled "Blueprint for Healthcare Reform." She also reprints a long article tracing his career, which is must reading for anyone not familiar with its arc.

Ezra Klein over at The American Prospect website asks Why Insurers Suck, and Five Way to Make Them Better. “It is actually counterproductive for insurers to compete on giving us the best care,” he writes. “It's not simply that they're not doing it, but given the structure of the marketplace, they shouldn't do it.”

For a different political slant, check out Beltway Insider Bob Laszewski’s Health Care Policy and Marketplace Review. He asks this week if Mom, Dad the Kids and Medicare – Would an Obama Presidency Energize Young Adults to Demand Entitlement Reform? . . . . Cutting it down the middle, Joe Paduda over at Managed Care Matters finds some small differences in the Clinton and Obama health care plans that matter. . . . And if you’re in the mood for a knock on consumer driven healthcare, check out David E. William’s post at the Health Business blog where he asks if consumers can really make use of the proliferating amount of data on the web about provider cost and quality.

The daisy chain in pharmaceutical manufacturing exposed via the Baxter International heparin scandal got Health Care Renewal up in arms. “Perhaps the self-appointed geniuses who manage our health care organizations need to re-think their clever business strategies of out-sourcing production to cut costs.”

Rob Cunningham on the hydra-headed Health Affairs blog rounds up the state of play on Health IT (last place in the high-tech division).

Meanwhile, a long list of heavyweights tackles the “sustainable growth rate” physician reimbursement system, which is scheduled for a 10 percent cutback come July and will occupy mucho time on the Congressional calendar as physicians and their professional societies work overtime to make sure that doesn’t happen. Paul Ginsburg, president of the Center for Studying Health System Change, suggests a more accurate relative value scale and better effectiveness research free from political interference (among his other spot-on recommendations).

The Urban Institute’s Robert Berenson (whom I had the pleasure of meeting recently and, IMHO, deserves a louder voice in the health care reform debate) offers an excellent explanation of who’s winning and who’s losing in the current system, and then concludes “payment for generalist physicians needs to increase. Payment for niche specialists can safely be reduced, perhaps with a redesigned expenditure target approach.” Amen to that.

Other offerings in the series include Mina Matin, Thomas Bodenheimer, and Kevin Grumbach on strengthening primary care and Jay Crosson of the Permanente Federation on a payment alternative. Gail Wilensky, senior fellow at Project Hope, will conclude the series, but that’s not up yet.

The Highlight Health Blog takes on the PLoS Medicine study showing that most prevention measures don’t save money for the health care system by pointing out that living healthy isn’t cost saving, but it is a cost effective way of living a longer, more productive life. But Jason Shafrin at the Healthcare Economist read that PLoS study and had a different view, while the Medical Humanities blog by Daniel Goldberg reminds us that the endless debate over health insurance reform forgets that "health and illness are primarily caused by social and economic conditions. It is these root factors that are left virtually unaddressed by acute care."

Meanwhile, Lisa Emrich at Brass and Ivory warns Big Pharma to keep its mitts off her medical records. . . .Lynch Ryan at Workers’ Comp Insider analyzes a proposed ADA Restoration Act to redress Supreme Court decisions that have undercut the definition of who’s disabled in the American Disabilities Act.

The health insurance issue is generating a lot of heat in the states, and you can get a peak at the debate in Georgia from the Insure Blog where Bob Vineyard has details on new legislative efforts to make health insurers justify their rates and a strong opinion on why they're doomed to fail. . . . The Colorado Health Insurance Insider describes how tough it is for women who’ve had infertility treatments to get or remain insured. . . .

On the incentives front, David Harlow’s HealthBlawg sounds off on payers not paying for hospital acquired infections; while the Physician Entrepreneur has some good things to say about corporate and insurance programs that offer bonuses to physicians who “raise the bar” on offering preventive care and better disease management. . . . Meanwhile, Vince Kuraitis at e-CareManagement assures us that the death of Medicare Health Support project, aimed at better chronic disease management, has not been greatly exaggerated.

And finally, Robert Jarvik of artificial heart fame drew lots of heat on the front page of the New York Times and in the blogosphere for promoting Lipitor under false pretenses. Health Care Renewal got some major media play from this post.

On Avastin, Why Not Register Results?

The Food and Drug Administration is considering expanding Avastin's labeling to include breast cancer. The outcome could have major policy implications for future cancer drug approval decisions, since the data submitted by Genentech in support of this anti-angiogenesis drug only shows an increase in time to tumor progression, not an overall survival benefit. The Wall Street Journal's Marilyn Chase this morning provides a good overview of the issues, including their financial implications for insurers, patients and Genentech.

A couple of things stand out. First, the drug's proponents claim that keeping the tumor in check by itself improves quality of life. Yet the side effects of adding Avastin to the traditional chemotherapy regime seem quite nasty. What's the evidence that quality of life was improved by increasing patients' time to tumor progression with this drug?

Moreover, if the data in these short-term trials don't show increased survival, then it is incumbent on the FDA to find out no matter how it decides the immediate issue of expanding the label. Thousands of women are already receiving this drug off-label. That would probably become near universal if it approves the drug for metastatic breast cancer, which kills 45,000 annually.

Traditionally, the FDA has asked companies to conduct post-approval clinical trials to resolve outstanding questions about the benefits and/or risks of a new drug. More often than not, the companies never complete them. In this case, Genentech apparently has one already underway, with data due in a few years.

But the agency could add on another approach. Why not require all physicians who use the drug, whether on or off-label, to keep careful (electronic) records of their patients' performance on the drug, and send that data to the FDA for analysis by the agency's drug evaluation and drug safety units? That data should also be open to outside investigators. (Think of what this would do to promote electronic medical record keeping, but that's another story.)

Observational data is not the same as data from a well-controlled, randomized clinical trial. But it seems to me that researchers would have a valuable new tool for evaluating drugs if the health care system began collecting solid epidemiological data from the real world use of drugs. Such studies would offer patients and their physicians another important source of information when deciding what is the best individual choice when it comes to imperfect drugs like Genentech's Avastin.

The Horrors! Dems Propose Spending to End Dependence on Foreign Oil

The fiscal conservatism frequently trumpeted by the mainstream media mixes incurious stupidity with gross hypocrisy.

The anger that led to this diatribe began Thursday while listening to NPR and hearing its correspondent describe Sen. Barack Obama's "green jobs" program as costing "$150 billion -- that billion with a B."

Then came Washington Post columnist David Ignatius this morning with a column fretting that Obama had "called for a $150 billion program to develop 'green collar' jobs and new energy sources. Meanwhile, to fix all the highways and bridges of our automotive society, he proposed a National Infrastructure Reinvestment Bank that would spend $60 billion over 10 years. Obama," sniffed Ignatius, "should be pressed on whether these big programs are affordable for an economy that appears to be in a tailspin."

Forget for a moment that there are only two time-tested ways to manage an economy in recession: either lower interest rates to encourage investment (monetary policy) or stimulate demand directly through government spending (fiscal policy). Ben Bernanke's Fed is belatedly doing the former. Is Ignatius suggesting a return to fiscal probity as the antidote to hard times? That was Herbert Hoover's position, and even FDR's in the run-up to the 1932 election, but it has been generally conceded in the intervening years that those views were outmoded. President Bush and Congress just agreed on giving cash grants to consumers to help pull the economy out of its tailspin. As Richard Nixon put it in the early 1970s, "we're all Keynesians now."

But let's put these particular proposals -- green jobs and infrastructure (which are really two sides of the same coin if the infrastructure program is properly designed) -- in perspective. These are ten-year programs, so their annual cost would be $21 billion combined. Let's compare that to what President Bush is spending in Iraq. For readers edification over the next nine months (until election day), I have added the National Priorities Project's "Cost of the War in Iraq" clock to my website. Within a few weeks, the total will surpass $500 billion or about $100 billion per year.

May I suggest to media pundits and reporters that the next time they are motivated to complain about the high cost of Democratic programs to end our reliance on foreign oil or repair our deteriorated infrastructure (remember that Minnesota bridge across the Mississippi that fell down?), the proper comparison is the war, and that a mere 20 percent reduction in the cost of the war will "pay" for it without any increase in taxes.

But, hey, I'm a fiscal conservative, too. I think we should raise money to pay for war or infrastructure investments (and I think a green jobs program properly structured should be considered one: investment in solar cell, windmill, hydroelectric and geothermal electricity production through tax credits and grants will reduce electricity costs over the long run).

As with any investment whose payback comes over a long period of time (like owning a home), the proper way to pay for these programs is debt. A $210 billion program over 10 years will cost about $2 billion a year in bond payments in the first year rising gradually to $20 billion a year by year 10 and then continuing for the next 20 years before gradually declining.

How might we pay for this? Here's a suggestion. The federal gasoline tax, now at 18.4 cents a gallon (state taxes vary but the combined tax rate on average is 45.9 cents a gallon) raised $39.4 billion last year for the highway trust fund. Without canceling a single bridge to nowhere, a two-cent increase in the federal gas tax would raise over $4 billion a year -- more than enough to pay for both programs plus give a $20 annual rebate to low- and moderate-income households that might be unduly burdened by this new tax (20 gallons per week times two cents times 50 weeks a year equals $20). In a market where the $3-per-gallon gasoline price fluctuates by a dime or more each week, how fiscally irresponsible is a two-cent federal add-on?

Or, we could peer a little harder at that $3 price. Earlier this month, ExxonMobil reported that it earned over $40 billion in 2007, shattering all previous oil industry records. Profits for the entire industry last year soared over $100 billion. During the late 1970s energy "crisis," the government slapped a windfall profits tax on industry that in today's dollars raised a peak of $23 billion in 1981. A windfall profits tax of comparable size (about 20 percent of profits) would raise enough money to fund both programs.

The windfall profits tax was phased out by President Reagan in 1987, and the course to our current predicament -- foreign oil dependence, endless wars in the Middle East, and collapsing infrastructure -- was set. Yet the presidential candidates who would propose faint half-measures to deal with these realities (like Obama's 10-year, $210 billion program aimed at energy independence and infrastructure repair) are scorned by the pundits for their fiscal irresponsibility.

Who's really the irresponsible one here?

You Must Visit the Journal of Irreproducible Results

Given the absurdity of the Food and Drug Administration's proposed new policy that would allow the distribution of peer-reviewed journal articles by drug industry salespersons, a senior physician at a major American medical institution was motivated to pass along this tongue-in-cheek solicitation, ostensibly from the Journal of Irreproducible Results, which is a real, live science humor magazine. You can visit that magazine's website (and subscribe if you're so inclined) by clicking on the link above:

Dear author,

We invite you to submit a review article advocating unapproved uses for any pharmaceutical agent. For major products, we can sell several hundred thousand reprints to the pharmaceutical company and we would be pleased to share our profits with you. Please consider our invitation.

The Editors

FDA Proposes Lack-of-Evidence-Based Medicine Policy

The Food and Drug Administration today proposed giving drug industry detailers the right to hand physicians reprints of journal articles touting the off-label use of prescription drugs. The proposed guidance was immediately blasted by Rep. Henry Waxman (D-CA), chairman of the House Oversight and Reform Committee, who called it "terrible for the public health. It caters to the industry’s desire to market their products without adequate testing or review."

Last December, Waxman's staff uncovered minutes of a meeting between top FDA officials and Dan Troy (who was general counsel at FDA during President Bush's first term) and other drug industry lobbyists. The industry spokesmen "expressed concerns about Federal prosecutors pursuing distributors of (joumal reprints) for criminal misconduct," according to the minutes. "There is confusion about the rules, possibly an FDA guidance could clarify the rules."

Waxman demanded the agency hold off on issuing its guidance until Congress passed a law protecting physicians and the public from a new burst of off-labeling marketing that would surely result from liberalization of the rules. His efforts were backed by state attorneys general fighting to hold down costs in their Medicaid programs and trial lawyers suing drug companies over illegal marketing schemes (the use of journal reprints promoting off-label use was a major element in the Neurontin case).

So what was in today's proposed guidance? It pretty much gives industry everything it was looking for. It would allow drug salespersons to drop off article reprints as long as they came from a peer-reviewed journal that had a conflict-of-interest disclosure policy. Articles from industry-funded supplements would not be allowed.

The policy also said the reprint couldn't be marked up in any way to highlight specific points, and must include a copy of the approved FDA label for the drug or device. It also couldn't be accompanied by other promotional literature for the approved uses.

Note what isn't in the policy: It doesn't say that the studies of unapproved uses must be from randomized controlled clinical trials, which is the gold standard of medical research. All the proposed guidance says is that the studies should be "adequate and well-controlled clinical investigations that are considered scientifically sound by experts with scientific training."

This is an open door for the drug industry to conduct more so-called seeding trials that encourage off-label uses. Because of their small size and lack of a control group, these trials are almost always of limited value in judging the true benefit of the drug in that off-label use.

Unfortunately, there are lots of second-tier journals in every medical specialty that publish dozens of such trials every year. And they will be happier than ever to take them since, should this guidance get adopted, they are likely to see reprint requests from drug companies soar.

Moreover, in exchange for the right to distribute literature on off-label uses, the company won't even have to pledge to submit an application to the FDA seeking approval for that off-label use. Not now, not three years from now, not ever.

As the nation grapples with how to pay for skyrocketing health care costs and policy wonks grapple with how to get more physicians to follow evidence-based medical practices, the Bush administration's FDA (the guidance was written by Randall Lutter, who was at the American Enterprise Institute before taking over the agency's policy shop) has proposed opening the floodgates to wider promotion and use of unproven drugs.

There's a name for that kind of policy: Lack-of-Evidence-Based Medicine.

Ill Omen on Heart Disease

A little-reported study that appeared in this week's Archives of Internal Medicine revealed a disturbing trend: heart disease among pre-retirement adults may be on the rise again after declining for more than 20 years through the late 1990s.

The study was based on a review of autopsies of 425 16- to 64-year-olds in the county surrounding the Mayo Clinic in Rochester, Minn. All had died of unnatural causes (murder, suicide, accidents) between 1981 to 2004. The reviewers found that over the entire period 8.2 percent of the victims had serious coronary blockages, and 83 percent had some evidence of heart disease.

But when looked at over time, the autopsies revealed that heart disease declined fairly steadily through 1995, but then began an upward tick -- coincident with the rise in obesity and diabetes in the area. It should also be pointed out that the rise was coincident with the introduction and widespread use of medications to reduce serum cholesterol, a risk factor for building up plaque in arteries.

The disturbing implication of a rise in the rate of heart disease is that the heart disease death rate, which has declined fairly steadily for decades, will soon follow. "The reversal in trends in young adults could precede that in older individuals in the future," University of Illinois demographers Jay Olshansky and Victoria Persky wrote in an accompanying editorial.

A recent study estimated that the decline in heart disease death rates in the last quarter of the 20th century should be equally attributed to better treatment and reduction in risk factors like smoking, obesity and diabetes. If it begins rising again, it won't be because treatment has gotten worse. That fact has clear implications for where attention should be paid over the next decade on the prevention-treatment spectrum of intervention opportunities.

Why Is NEJM Bad-Mouthing Prevention?

The lead Perspective in today's New England Journal of Medicine takes aim at candidates (all but John McCain among those who remain in the race) who place prevention near the top of their health care priorities list. Some prevention strategies do save lives at no or low cost, they write, but "sweeping statements about the cost-saving potential of prevention are overreaching." Further, "broad generalizations made by many presidential candidates can be misleading" because "the vast majority (of prevention interventions) reviewed in the health economics literature do not."

The article, lead authored by Joshua T. Cohen from the Tufts University Center for the Evaluation of Value and Risk in Health, concludes that "careful analysis of the costs and benefits of specific interventions, rather than broad generalizations, is critical." Finally, the authors state that careful analysis should also be applied to treatments as well as prevention to "encourage the appropriate delivery of efficient interventions."

What's the data to support this skeptical view about the potential for prevention? They analyzed 599 articles in the health care economics literature that looked at various health care and prevention interventions for their cost-effectiveness, with the standard measure being the cost to save one quality-adjusted life year or QALY. Those articles analyzed 1,500 interventions, of which just 279 involved prevention strategies like smoking cessation or prophylactic aspirin use to prevent heart attacks.

The authors then stratefied them within each group for their cost-saving potential, and compared the two groups. So about 19 percent of the prevention strategies saved money right off the bat, compared to 18 percent of the treatment strategies. Another 48 percent of prevention strategies saved lives for less than $50,000 per QALY compared to 50 percent of treatment strategies.

Is this really six of one, half dozen of the other, which is the essence of their conclusion?

An analyst who used their perspective and looked at the raw numbers a different way could have drawn this conclusion:

Among health promotion strategies analyzed in the economics literature, there are four times as many medical treatments being offered patients today that are not cost effective (using a commonly accepted benchmark of $50,000 per QALY as a cutoff point for cost-effectiveness) as there are prevention strategies that are not cost effective. Indeed, over 80 percent of treatment interventions cost more than they save, just as over 80 percent of prevention interventions cost more than they save.

Why didn't they make that the emphasis of their article?

Moreover, their stratification tells us nothing about what is currently being deployed by the health care system. Only that tells the public and health care analysts what potential each strategy has to save lives and at what cost.

For example: only 40 percent of men over 40 and women over 50 at risk of a heart attack regularly take aspirin as a prevention strategy. Getting that up to 90 percent would save 45,000 lives annually at no cost to the health care system, according to the Partnership for Prevention, a business-backed health care reform coalition.

On the other hand, cholesterol screening for men over 35 and women over 45 to reduce heart attack risk is already at 80 percent of the population. The nation is currently spending about $20 billion a year on drugs to reduce cholesterol that translates into a cost to the health care system of somewhere between $15,000 and $50,000 for every QALY saved.

Both are below the $50,000 benchmark. But which has the greater potential for the least cost?

Moreover, I would like to know what were the interventions in each group that fell above the $50,000 per QALY benchmark. How many are being widely deployed? The study would have been truly enlightening if they had added this third variable to the analysis: how many patients are being offered each treatment strategy, whether prevention or treatment. Then, we could have analyzed the overall cost-effectiveness of our health care system as it currently exists and come up with some rough estimates for the true potential of prevention.

I can't know if it affected his thinking, but Dr. Cohen through his prior work at the Harvard Center for Risk Analysis has conducted research for numerous industrial groups, including housing (lead in children), telecom (cell phones and driving) and food (mercury and fish). The Tufts Center where he works has received unrestricted educational grants from numerous drug companies.

Whatever accounts for his "perspective" on these issues, the fact is that another analyst using the very numbers contained in the studies under review could have drawn a very different conclusion, one that wouldn't have started by raising questions about the candidates who are providing a wonderful service to the American people by reminding them that prevention -- both at the personal and health care system level -- should be near the top of the list of priorities when it comes to thinking about the nation's health.

Institutional Conflicts of Interest

Nearly a decade ago, an 18-year-old student named Jesse Gelsinger died in a gene therapy experiment at the University of Pennsylvania. It was run by a physician-professor who had invented the technology; started a company to develop it with the university's financial support; and used the company's cash to finance the clinical trial, which was conducted at the university. The disclosure forms signed by the patient and his family did not adequately reveal the risks involved.

In the wake of that ethical fiasco, the U.S. Department of Health and Human Services issued guidance to academic medical centers to adopt policies governing the so-called institutional conflicts of interest that exist when universities have a proprietary interest in a technology under development in its labs and clinics. But a new survey published in the Journal of the American Medical Association today found that by 2006, just 38 percent of the nation's academic medical centers had adopted such policies (30 of the 86 institutions that responded; there are about 125 medical schools in the U.S.). Another 29 are working on them.

Even more disturbing was the limited scope of the policies that were put in place. Most of the policies had strict guidelines for top officials at the universities. They had to reveal institutional conflicts of interest. But to whom? The study's authors noted:

The 2004 U.S. Department of Health and Human Services guidance urges institutions to establish policies for conflict of interest committees to provide information, recommendations, and findings to Institutional Review Boards [or IRBs, which are required by law to oversee clinical trials to ensure they adhere to ethical standards]. Substantial gaps exist in informing institutional IRBs of potential institutional conflicts of interest in research projects under review, other than of those of its own members. This is a disturbing finding, may be contrary to federal guidance, and calls for prompt institutional attention.

Note the implicit assumption in the study's finding. It's okay for IRBs to be staffed by physicians or administrators with conflicts of interest.

This raises an important question. Does disclosure of conflicts of interest to members of an IRB -- whether they exist within the institution, the management of the institution, or within the IRB itself -- ensure that the trial under review adheres to the highest ethical standards? Isn't it possible that those conflicts will influence the review? And doesn't the mere presence on the IRB of someone with a stake in the outcome of that trial create the appearance that the conflict of interest may have influenced a decision?

Appearances matter. What if something goes wrong in the trial, like what happened in the Gelsinger case. Won't someone point to the presence of an IRB member with a conflict of interest and suggest that it was due to lax oversight? Would an IRB or its institution want to see that allegation spread across the front page of its local newspaper?

In my view, when it comes to IRBs, anyone with a conflict of interest that relates to a particular trial under review should recuse themselves from overseeing and making any decisions about the ethical validity of that trial. Surely universities can find people without conflicts of interest to sit on these IRBs, which are a crucial firewall for protecting the safety of participants.

Meanwhile, an accompanying editorial by David Rothman of Columbia University's Center on Medicine as a Profession ignored the weaknesses in the policies being adopted by the minority of institutions that have adopted them. Instead, he raised the specter of mandatory federal regulation if the slow-moving universities don't get off the dime and enact policies of their own.

"Will government regulation step in to fill the vacuum? Current federal and state interests in industry-academy relationships provide reason to believe so. Congressional hearings are addressing the implications of industry support for continuing medical education, gifts to clinicians, the sale of physician-prescribing data, and pharmaceutical company efforts to intimidate researchers critical of their products. Currently eight states and the District of Columbia have laws or resolutions affecting marketing of pharmaceuticals. Thus, it may not require another Gelsinger-type incident to bring about significant regulation and legislation."

It's not clear that Congress will pursue the issue. Just a few weeks ago, the HHS inspector general issued a report lambasting the National Institutes of Health for failing to oversee or even collect data on the conflict of interest policies that grant-receiving institutions are supposed to enact for investigators that get the NIH grants. The agency responded by rejecting the IG's suggestion that NIH collect conflict-of-interest disclosures from universities. It would appear you can lead the government agency to water, but you can't make it drink.

There is a solution, of course. Forget about "guidance." Congress could step in and pass a law that prohibits investigators or university officials with conflicts of interest from sitting on IRBs and requires NIH to collect conflict-of-interest disclosure data from grant recipients and post it on its grants database (it's known as the CRISP database). To enforce the law, NIH could cut off all federal grants to that institution if those policies aren't adopted by a date specified in the legislation.

That would get medical schools' attention, and provide institutions, IRBs, investigators, journal editors and the public with a useful tool for managing conflicts of interest.

Wellness Programs Face Backlash

In an effort to hold down health care insurance costs, many employers are establishing so-called wellness programs, designed to encourage employees to quit smoking, lose weight, keep blood pressure under control and take other preventive measures that should improve their overall health.

There's two ways to go about it, of course. One is to penalize employees by raising their health insurance co-payments if they persist in unhealthy behaviors or don't meet wellness goals. The other is to give them bonuses for achieving targets in the form of reduced co-payments or paycheck bonuses.

My former employer, The Chicago Tribune, ran an interesting story over the weekend about the backlash against one program that penalized workers. It's worth reading for insights into this fast-growing trend in corporate America.

It's also interesting to note that the company featured in the story, a health insurance company, was able to diffuse the opposition and gain much better results from its workers when they adopted the bonus approach to rewarding people who met health care goals.

Gov't. Scientists Whistling in the Dark

Top officials at the Centers for Disease Control are blocking publication of a 400-page, peer-reviewed report documenting toxic hot spots in the eight-state Great Lakes region after demoting the scientist who led the study, the Center for Public Integrity reported last week. The House Science and Technology committee is investigating.

In a letter sent last week to CDC director Julie Gerberding, Rep. Bart Gordon (D-TN) questioned the seven-month delay in issuing the report, and asked for details on “disturbing allegations about interference with the work of government scientists” at the CDC’s Agency for Toxic Substances and Disease Registry (ATSDR). The report, which warns that more than nine million people may face elevated health risks from exposure to dioxin, PCBs, pesticides, lead, mercury, or six other hazardous pollutants, was slated for release last July.

The study’s chief author was Christopher De Rosa, the director of ATSDR’s division of toxicology and environmental medicine and, according to the story, “a highly respected scientist with a strong international reputation from his 15 years in charge of the division.” Howard Frumkin, the chief of ATSDR, told him the Great Lakes study was “well below expectations” and removed him from his position. De Rosa is seeking reinstatement to his former position, claiming that Frumkin illegally retaliated against him. CDC officials refused to talk to the Center for Public Integrity.

In another case involving whistleblowers, the Food and Drug Administration is being asked to document all meetings between its staff and companies regulated by the agency. Sen. Charles Grassley (R-IA) called for the change last week in the wake of an investigation that found the agency blindly accepted conflict of interest charges leveled by a private company against one of its scientists. The Center for Veterinary Medicine removed adverse events coordinator Victoria Hampshire from her position in January 2005 after top officials at a Wyeth Pharmaceutical subsidiary lodged the complaint. At the time, Hampshire was preparing to go before an advisory committee where she planned to oppose reintroduction of the company’s ProHeart 6 canine heartworm drug, which triggered severe allergic reactions in some dogs.

At a private meeting two months prior to her reassignment, company officials gave then acting FDA Commissioner Lester Crawford and chief counsel Dan Troy numerous slides from a private investigator’s report that accused Hampshire of running a website that sold a competitor’s product. Grassley’s investigation found those allegations to be false. Moreover, the FDA’s Office of Internal Affairs used those documents, which Grassley called “rife with error” and easily refuted, to seek a criminal investigation of Hampshire. “Industry representatives ought to have a good working relationship with FDA,” he said, “but under no conditions should the scientific process be compromised by industry pressure.”

Meanwhile, whistleblower protection advocates are hoping the House and Senate will quickly reconcile and approve legislation that would protect scientists like De Rosa and Hampshire. Besides beefing up legal rights that have been largely eviscerated by the U.S. Court of Appeals for the Federal Circuit (it has rejected 179 of 180 whistleblower complaints), the House version would prevent federal agencies from retaliating against scientists who reveal when their superiors distort or suppress government science. The Bush administration has lobbied against both versions of the bill and threatened a veto.

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

An American Health Care Story

A friend wrote this week with this unhappy news:

On Sunday night, my former foster child Josh was beaten up with a baseball bat (after being held up at gunpoint and telling the marauders he had no money) on his way home from a SuperBowl party, and refused admission to the first hospital his sister tried to take him to. He was finally taken to John C.
Lincoln Hospital, which has a Level 1 Trauma Center.

The injury was severe, although he will live. Every bone in his face was broken, his nose was smashed, his teeth were shattered, and his eye sockets all but destroyed. He will need a least three re-constructive surgeries. Never mind the psychological consequences on a kid that already has lost both his parents and, as he aged out of the system, his foster parents.

And, of course, he is uninsured. He is 20, and thought he was immortal. He was also working on and off, sometimes at jobs that provided insurance, sometimes not. So he never registered for ACCCHS, Arizona's version of Medicaid.

So he was thrown out of the hospital on Thursday, because the reconstructive surgeon can't get to his case until Monday, and the hospital won't keep him. He's enrolled in ACCCHS now, because of course the hospital enrolled him immediately so they could get reimbursed for his care. But ACCCHS won't allow him to stay in. So he goes "home" to sleep on the floor of the apartment his pregnant sister shares with another single mom with two kids.

Then comes Super Tuesday, with all the candidates ranting about the need for universal healthcare. But none of them saying it should be paid for by anyone but the insured or the employer. This is an interesting conundrum to me. Let's just say health care was the most important issue for me, which it is. Who should I vote for? Barack, who says there shouldn't be a mandate to buy it? Hillary, who says it should be mandated but doesn't tell us how a kid like Josh will pay for it? The Republicans, who want a "free market" solution?

Folks, as far as I can see, nothing would cover Josh, who works part time and intermittently while trying to go to school, or his sister Amanda, who keeps on losing jobs because of her skills deficiencies, or his brother Jerry, who is working for a company that does not offer health insurance and can't get on ACCCHS because he's a former felon. Or the 47 million who "reject" health insurance that is offered to them because they can't buy it and also buy gas.

Health insurance is not like automobile insurance. You can mandate automobile insurance, and if people can't afford it, they can take the bus. You can't just "mandate' health insurance. Either health care is a right that society provides, or it is not. It's interesting how the system now works. As the system stands, drug addicts, diabetics who don't comply with their regimens, and smokers who give themselves COPD can get care, as long as they either can afford to pay for insurance (pay for their sins by buying insurance and shifting the cost of their care to the rest of us) or are dirt poor. In fact, the poorer they are, the better the care. And the worse people take care of themselves, the better the care they get. You can get a heart transplant more easily than you can get a colonoscopy.

It's the working poor, the people trying to lift themselves out of poverty, who don't get care. And trust me, one day that will include someone from your family.

Another New Health Wonk Review

The latest Health Wonk Review has been posted on David E. Williams' Health Business Blog. Check it out!

Medicine and Information

Some health care reformers and most presidential candidates put electronic medical records high on their list of needed improvements for the U.S. health care system. Last year, when I switched primary care physicians, I had to pay $35 to get the assistants in my old doctor's office to make photocopies of my records in the manila folder, which I then hand-carried to my new doctor's office, where they were placed in a new manila folder. Moving to electronic recordkeeping would certainly make the process easier and my records more easily accessible.

But there's an old saying from the early days of the computer era when mainframes dominated the landscape that may be applicable here. Garbage in, garbage out, programmers used to say about the data poured into their hulking machines, and that may be worth contemplating as we move toward electronic medical record keeping.

Two new reports highlight the information deficit in our medical system that electronic medical recordkeeping may give us a tool to address, but doesn't in and of itself resolve. The Institute of Medicine last month called for a new national organization to conduct systematic reviews of medical evidence and write objective clinical practice guidelines (CPGs) for use by the nation's medical practitioners. "Knowing What Works in Healthcare: A Roadmap for the Nation" said a centralized authority for writing guidelines was necessary because:

With thousands of new clinical studies published every year, the amount of medical data has become so vast that it is essentially unmanageable for providers, patients, health plans, and others. Most people, including many health professionals, lack the scientific training necessary to evaluate and interpret such clinical findings by themselves. Moreover, research has shown that when evidence reviews are financed by manufacturers or vendors — as a significant proportion are — they are more likely to show effectiveness, which leads some to question whether, or to what extent, the cumulative body of evidence for any given health care product or service is biased.

But when this new agency sets out to gather the available evidence to write its CPGs, what will it find? The problem of generating real-time information from our clinical trial system was one issue addressed by the business-backed Committee for Economic Development in its new report, "Harnessing Openness to Transform American Health Care." Its perspective on the clinical trial information system, which ultimately is what clinical practice guideline writers must depend upon, is worth noting:

Most important for improved healthcare research is to make the trial results and the data underlying trials more accessible more quickly in a form that is searchable and computable using common standards. In addition, applicants for FDA approval should be required to submit all studies they have conducted on the intervention with any safety-related results being made publicly available. . . The Council joins a long list of groups recommending far more comparative testing of drugs to supplement clinical trials that simply compare an intervention’s effects with those of a placebo.

In theory, the recently enacted Food and Drug Administration reform law dealt with the first part of this problem. All clinical trials beyond the earliest safety trials are now going to be registered, and their results publicly posted. But will they be in a form that is easy accessible to desktop researchers across the country, indeed, across the globe? And when will the FDA publish its standards to bring clinical trialists, whether working in the public or private sector, into compliance with the new law's public posting requirements? I haven't seen any proposed regulations from the agency. Hopefully, it will get off the dime and publish them soon.

Super Tuesday

The stark message from yesterday's vote is how little has changed among the U.S. electorate despite seven years of feckless Bush rule that brought us an endless war, a looming recession, and managerial incompetence. A few observations:

Arizona Republican John McCain has become the frontrunner for the Republican nomination by winning primaries in states that almost always go Democratic. But how different is his emerging triumph from the outset of George W. Bush's own ascent to the presidency in 2000? He, too, posed as a moderate -- remember compassionate conservatism? -- to gain mainstream voters' support.

On the Democratic side, the Clinton-Obama split reflects the divisions in the party that have been there since 1972. The young, the antiwar, and the university-town ghettoes support the insurgent candidate, while the traditional base of the party -- the blue, pink and gray collar workers that haven't defected to the Republicans over cultural issues, the baby boomer soccer moms (now morphed by the miracle of time into empty-nesters and grandmoms), and minorities -- go for the consensus candidate of the party machine. The vote is only close because one element of the traditional coalition, African-Americans, is voting along ethnic lines. They, like the insurgent wing of the party, will like Hillary well enough if and when she wins the nomination.

Clinton did well in traditional Democratic bastions -- Massachusetts, New York, New Jersey, California. Obama won Illinois, but that was a favorite son vote. Meanwhile, Obama did well in states that in recent years have leaned Republican, many of which held caucuses yesterday, not voting primaries. That's testimony to the organizational energy he's brought to the campaign. But I fear he would lose those states in a landslide against almost any Republican candidate.

So now that Super Tuesday has come and gone, where are we? Michael Gerson, a former Bush speechwriter turned Washington Post columnist, in this morning's paper warned McCain that he couldn't remain "uncurious" about domestic politics. If the wobbly U.S. economy nosedives and pocketbook issues take center stage, any Republican will have a hard time winning.

But if the slowdown is mild and the economy rights itself by mid-year, as some economists predict, then the election will become a referendum on the war, no matter who becomes the Democratic candidate. Do we want to move rapidly toward a green economy and ending the war, or do we want to be an empire that endlessly engages in low-level conflicts in the Middle East to protect our oil-based way of life?

It's rare in politics when the choices are so stark. Do we want Democracy and a focus on domestic issues? Or do we John McCain's 100 Years War? For me, the choice is easy. But don't underestimate the power of nationalism and jingoism. The whole country wanted the Vietnam War to end by election day 1968. But the "emerging Republican majority" narrowly voted for Nixon and "peace with honor." That's McCain's slogan, too, even if he doesn't use precisely those words. And in Clinton, he would face the one candidate capable of resuscitating that doddering Republican coalition for one last hurrah.

DDT and Malaria -- Again

The conservative campaign to make DDT a centerpiece of malaria control efforts in Africa continues unabated, and today the Alternet news service ran an insightful if long-winded article that provides a decent overview of the issues. Journalist Kim Larsen early on points out that DDT even when used only for indoor residual spraying is no magic bullet, largely because mosquitoes develop resistance. Allow me to quote her at length:

Today's most ardent proponents of DDT suggest that the sole obstacle to routing malaria half a century ago was the onset of the environmental movement. Mosquito resistance to DDT and the crippling logistics of effective spraying campaigns are overlooked in favor of the much juicier target of Rachel Carson and her green descendants. Carson's 1962 book, Silent Spring, was indeed a watershed. Invoking DDT as Exhibit A and sounding her alarms in graceful, elegiac prose, Carson awakened readers to the idea that pesticides might have a downside.

The use of DDT was banned in the United States in 1972. But while the chemical is no longer manufactured here, other organochlorine compounds are, and many are or are likely to be subject to scrutiny by regulators. This may be what really concerns DDT's more aggressive advocates in the private sector. In a chapter of a book on "message crafting," economist Roger Bate, a fellow at the Competitive Enterprise Institute, warns, "DDT may be today's target, but it's not going to be long before chemicals that the industry cares about are added to the POPs Convention and other chemicals regulations."

DDT proponents are generally reluctant to acknowledge the complicating and protean factor of mosquito resistance. Entomologist May Berenbaum finds this galling. An expert on insecticide metabolism, Berenbaum is director of the entomology department at the University of Illinois at Urbana-Champaign. "Read the entomological literature of the 1950s," she said in a telephone interview. "Way before Silent Spring, scientists were already trying to understand resistance. That's what insecticide toxicology was all about back then. Resistance to DDT was first detected in Italy, in houseflies, in 1947!"

Environmentalists' objections to DDT, Berenbaum said, were just one piece of an intricate puzzle. In a 2005 Washington Post article that discussed mosquito resistance to DDT, she warned: "Overselling a chemical's capacity to solve a problem can do irretrievable harm not only by raising false hopes but by delaying the use of more effective long-term methods."

After Berenbaum published the article, she said, she was barraged by e-mails demanding that she support her claims. "To get them off my back, I finally culled a list of peer-reviewed articles documenting resistance to DDT and other pesticides in pockets all over Africa. This is not my life's work. I spent 10 minutes--10 minutes--and I found 15 articles. What would I have found if I'd spent an hour?"

She concludes:

DDT will continue to play some role as a front-line weapon in the malaria wars. But it is also a distraction. DDT won't pave a watercourse or feed a child or provide a job, and at the end of the day, malaria is a development issue.

Krugman on Mandates

I'm offline except for brief moments over the next two days, but I couldn't help but note Paul Krugman's off-base comments in today's New York Times. Here's an interesting response from economist Dean Baker at the Center for Economic and Policy Research, writing on the American Prospect website:

It’s not often that I take issue with Paul Krugman’s economics (at least not recently), but he does misrepresent the issues in going after Obama on health insurance mandates.

The simple story is that any effort to establish national health insurance will require some anti-free loader mechanism to prevent gaming. The logic is straightforward. Everyone agrees that we want to get rid of the current practice under which insurers are allowed to charge fees based on people’s health. Under this system, people with serious illnesses either must pay exorbitant fees or are unable to get insurance altogether. (Insurance companies lose money if they insure people with high bills.)

Under a reformed system, we will require a standard fee under which everyone pays the same rate regardless of their health history. However, this creates a situation in which it doesn’t make sense for healthy people to pay for insurance. Why not just deal with minor health related costs out of pocket? You can wait until you get sick and then buy into the system and pay the standard rate.

That works for healthy people, but it would destroy the system because the only people buying insurance would be those with relatively high bills. This means that insurance would be very expensive, which of course encourages more people to play the “wait till I’m sick strategy.” The end result is that the system collapses, because only the very sick would ever find it worthwhile to buy insurance.

One way around this problem is to mandate that everyone buy insurance. Senator Clinton has proposed a mandate as an explicit part of her plan. Senator Obama has attacked Clinton for this mandate (sometimes unfairly). By contrast, he has suggested that we can get near universal enrollment through other mechanisms. Specifically, he has suggested that we can have a system of default enrollment, whereby people are signed up for a plan at their workplace.

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

A system of default enrollment will ensure that people do not remain uninsured due to inertia. A system of late enrollment penalties will ensure that people don’t try to game the system.

Is the Obama mix as good at reaching universal or near universal insurance as the Clinton mandate? The reality is we don’t know. It will depend on many factors, most importantly the sanctions that are imposed under both systems (i.e. the penalty for not getting insurance with the mandate, and the late enrollment penalty in the Obama system). Krugman is wrong to say that a mandate is necessary. We can get to the same place with Obama’s approach; it really depends on the details.

Unfair and Unbalanced Wonkery on Mandates

After California Gov. Arnold Schwarzenegger's health insurance plan went down in flames earlier this week, I made it a point to listen in to the Kaiser Family Foundation online forum yesterday discussing the role of individual mandates in guaranteeing health insurance for all. The failing Massachusetts plan has a mandate, as did the California plan. It was the number one reason why liberal legislators in the nation's most liberal state turned thumbs down on the proposal, claiming it would penalize low- and moderate-income Californians by putting a gun to their heads to buy insurance plans they couldn't afford.

Mandates were also a central issue in last night's Democratic Party debate, with Sen. Hillary Clinton backing them and Sen. Barack Obama opposed. It was one of the few points of contention in an otherwise cordial faceoff.

For the record: I'm opposed to mandates for two reasons. First and foremost, they're bad politics. Americans don't like to be told to do anything. They especially don't like unfunded mandates.

That leads to point two. Without sufficient taxes on businesses that don't provide insurance to their employees and/or significant savings from health care cost control (not likely given the opposition of insurance companies, drug companies, hospitals, doctors, and other providers in the system), mandates will result in inadequate plans for the uninsured -- catastrophic plans that still leave the newly insured at the emergency room door for basic care and without preventive services. Higher taxes are a prescription for political failure. Lousy plans maintain the status quo in public health. Some choice.

Clinton's plan does have one element in it that might make her mandate palatable. She would create a public sector default plan for the uninsured if they can't find adequate insurance in the private marketplace. But the new national plan with a mandate would face the same conundrum as California: if you keep pay-or-play provision low to forestall opposition from small businesses, you have to supplement the new government plan with general funds, just as Medicare is now subsidized with general funds. That's the only way to keep the co-pay for individuals mandated to buy insurance affordable while still providing decent insurance. And for the lower middle-income families who are too rich to qualify for subsidies but too poor to afford unsubsidized insurance, that's crucial.

This new plan wouldn't be "Medicare for all," sometimes known as single-payer. But it would establish the government as the default insurer and one option for the uninsured who cannot afford the new plans being offered individuals in the private market.

Let's be clear about what it is not: It is not socialized medicine, where the government provides health care. The government doesn't provide health care for the nation's 43 million Medicare beneficiaries. Most of them choose their own doctors, who remain in private practice, and go to private or public hospitals. The Center for Medicare and Medicaid Services, which runs Medicare, negotiates some prices for these services (alas, not drugs) and sets reimbursement schedules for providers, but it remains a distinctly private sector affair. The government pays, and our mixed system of private and public health care providers supplies.

I lay this out at some length because the Republicans this fall are likely to attack the Democratic plan as "socialized medicine." They want to give individuals tax breaks and send them on their own into the dysfunctional individual insurance market, where high-cost or high-deductible plans routinely discriminate against those with pre-existing conditions. But rhetorically, they will be offering "individual choice" versus what they will call "socialized medicine." If the Democrats' eventual nominee includes a mandate and/or the government default option in their plan, it will be pointed to as evidence that he or she backs "socialized medicine."

In an America that does not understand the complexities of the health care system and will not be given the information needed to vote intelligibly on the issues, that's a debate that the Republicans can easily win, especially if it supplemented with a mass advertising campaign by the drug and insurance industries, which have the most to lose under the Democrats' proposals. It appeals to some of the most deeply ingrained aspects of the American character -- rugged individualism, choice and low taxes. That it's bad for your health is the can that gets kicked down the road.

That's why it's so important that the independent arbiters of the health care debate be very careful to correct inaccuracies when the media or health care wonks label the government default option or single-payer health insurance -- which isn't even on the table -- "socialized medicine." Yet in yesterday's Kaiser Family Foundation forum, two policy wonks -- Michael Gordon of the libertarian Cato Institute and Len Nichols of the centrist New America Foundation -- both referred to single-payer health care as a system that, to use Nichols' words, "turns physicians, clinicians into employees of the government."

I don't expect better from Gordon. But this was so fundamentally wrong that it is hard to believe that Nichols, who is one of the leading architects of the individual mandate movement, didn't know he was telling a lie. Perhaps he was upset that his handiwork in California had been shot down. Whatever.

The sad part is that the moderator of the discussion, Larry Levitt, did nothing to correct that lie. That's too bad. As the mandates contained in the Massachusetts and California plans collapse, the movement for universal coverage will need a full and frank discussion about other alternatives. The good folks at KFF can start the process by inviting the full range of opinions onto their panels, and only include those who accurately describe the options.