FDA Reform Is in the Air

The Food and Drug Administation, responding to the scathing Institute of Medicine report issued last September, launched a preemptive strike on drug safety yesterday to forestall legislative changes. You can read the details in news accounts here, here and here, or look at the FDA's own documents here.

It's a start, was the generous consensus. "Small potatoes," said Consumers Union, a view generally in line with my own. When I asked the head of the Center for Drug Evaluation and Research whether the agency would force companies to conduct post-marketing safety trials (most of those requests, issued at the time of approval, are ignored by the companies), Steve Galson replied that it would be up to Congress to give the agency that authority. Yes, but that begs the question, Dr. Galson. Do you want that authority? Will the Bush administration you serve ask for it in the budget request released next week? And, if it is given, will you use it?

The agency was also dodgy in its response to the issue of prohibiting scientists and physicians with conflicts of interest from serving on its advisory committees, which play a powerful role in determining if marginally effective or mildly dangerous drugs (because of side effects) get to market. These are the risk-reward trade-off decisions that the agency is often called upon to make, the ones that are as much about human judgment as they are about science. They often turn to outside advisers for help in that process through a committee structure that has received withering criticism from consumer groups and some physicians as being overly biased toward approving new drugs. Getting rid of conflicted advisers -- even though their votes have been shown to not be all that different from advisers without conflicts of interest -- would open slots for creating more balanced panels.

Randy Lutter, who manages policy for the agency, did say that the agency planned to put more epidemiologists on these committees, which presumably would give them additional insights into how drugs affect large populations once on the market. But he refused to give a definitive answer to how they'll handle the conflict-of-interest issue. We'll have to await a guidance document, which will be released later this year.

Meanwhile, Sens. Chris Dodd (D-CT) and Charles Grassley (R-IA) told the New York Times that they plan to reintroduce their legislation calling for a legislative overhaul of the agency. Which brings me to the final curious comment in that story. Scott Gottlieb, who recently left his political appointment at the FDA to return to the conservative American Enterprise Institute, said that the real battle this year will be over FDA intrusion into the practice of medicine. “I think we need to give the agency the resources it needs to get information about drug risks quickly,” he said. “But we don’t need the government telling doctors and patients what to do.”

I can think of two reforms that would constitute such an intrusion. One would be a requirement that all new drugs coming before the agency get tested against existing therapies as part of their initial regulatory approval process. This would provide physicians with important information for determining if the new drug was any better, or worse, than what's already out there. This might be a blow to the marketing departments of major pharmaceutical firms, but a solid advance for evidence-based medicine.

The other reform would be further restrictions on physicians' ability to prescribe drugs for other than their FDA-approved use, so-called off-label prescribing. Many of the worse abuses of the drug marketers have come from their illegal promotion of off-label use of drugs.

If these are the issues Gottlieb referred to, I say, bring it on. These would be very valuable discussions to have in Capitol Hill hearings later this year, say around reauthorization of the Prescription Drug User Fee Act, which provides over half the funds for the FDA's new drug approval activities and expires next October.

The Unspeakable Remedy to the Health Insurance Mess

A colleague just sent me a link to an online ABC News commentary by Nortin Hadler of the University of North Carolina. Because it reflects his long medical experience (and echoes so many of the themes I've elucidated here in recent weeks), I am posting it in its entirety:

None of us needs to be told. The health care delivery system in America is indefensible. About $2 trillion fuels the system, some 16 percent of our national productivity. If we were all covered, that's more than $6,500 per person.

Despite such a fortune, about 40 percent of us can't afford the care we are told we need, either because we are inadequately insured or out-of-pocket payments would bankrupt us.

Medical bills broke the back of more than 40 percent of us who have declared bankruptcy. Even those who feel adequately insured are bedeviled by difficulties in getting care; those inadequately insured are tormented by them.

Despite outcries, this sorry state continues to deteriorate. Why?

Clearly, the cause is not a lack of money. Every other resource-advantaged country indemnifies its entire population with less than half of what we spend, with better national health statistics to show for it.

The problem must reside in the way the money is spent.

Is the "Best" Medicine the Most Effective Medicine?

The guiding principle of all health care reform in America is the belief that American medicine is the "best" in the world.

Reform would tackle misdistribution and the inconsistencies in the quality of care. Once these are overcome, all of us will be afforded the "best" to prevent us from getting sick, and the best to heal us when prevention fails.

The savings that would result from a decrease in the national burden of illness would be enough to provide for adequate distribution of care.

It follows that the goal of health care reform is to make certain that American medicine is performed expertly so as to provide optimal quality of care.

Serving this agenda are national committees to establish the criteria for expert care for particular diseases, national committees to collect the data on how particular states, hospitals or practice groups approach these standards, and national committees to see if it matters.

Much of this effort has taken heart disease as the target because of the volume of cases, the costliness of treating these diseases, and the consensus as to the best care. Many a program has been implemented to move practice up to these standards.

The quality movement is enjoying its day in the sun. Legislators and potentates in the hospital and health insurance industries are beating the drum. Few are questioning the basic premise of the quality movement.

Does it matter to the patient if practice meets these consensus standards? There is a crying need for such heresy.

A recent analysis of the Medicare experience (JAMA, Dec. 13, 2006) should muffle the drumbeat. The degree to which practice met the accepted standards for Medicare patients admitted for heart disease did not predict who lived and who died.

Even for the poster child of the quality movement, heart disease, something is amiss.

Focusing on Quality Alone Could Compromise Care

Why wouldn't performing up to these standards of care for heart disease, to "high performance," be advantageous to the patient?

Maybe the Medicare analysis could not detect the shortcomings in the way doctors and hospitals meet standards of care.

More likely, though, is that the standards of care are far less important than the committees that formulated them pronounce.

If what we do to you doesn't work, or doesn't work much, than it doesn't matter how well we do it. It also doesn't matter how cheaply these services are provided; if it doesn't work it's worthless at any price.

The quality movement is putting the cart before the horse. The "horse" is efficacy.

The quality movement overcame great odds to gain its current influence. Physicians and surgeons, like other professionals, are not reflexively disposed to "outsiders" questioning their competence. Even peer review is a prickly process.

I applaud the quality movement and admire many of its leaders. However, quality is not the goal. It is the process. Efficacy first, then quality, promotes effectiveness.

There is an "effectiveness movement," bloodied and bent but unbowed. It can muster far more illustrative science than the quality movement.

But the forces that thwart the demand for effectiveness are powerful, wealthy and predictable.

Most of the high-ticket items (procedures and pharmaceuticals) are minimally effective, or ineffective. Many of these are considered standards of care. Many are cash cows touted by vested interests.

Effectiveness Key to Performance
From my perspective as a clinician who has cared for patients and taught students for more than three decades, if I have to treat more than 20 patients to do something really meaningful for one, the treatment is marginal; I do not prescribe or advocate it and would have no problem if it was not covered by health insurance.

If this seems extreme, consider the fact that many new and expensive treatments available today do not meet the threshold of meaningful results for even one out of 50 patients.

Furthermore, designing trials to test whether new or old treatments meet this one in 20 level of effectiveness is not difficult, expensive or time consuming. We would no longer be marketed to prescribe and consume minimally effective treatments, or treatments that offered no important improvement over the tried and true.

If we have effectiveness at the base of our health care insurance system, adding cost-effectiveness and quality would be rational and straight forward. We could well afford such a rational health care delivery system, with most of the $2 trillion to spare. We would be more "high performance" than any other country.

And our unsung, well trained and caring physicians, nurses and allied health professionals could get back to serving patients instead of the health care delivery system.

NKF Cloaks Conflicts on Eve of Crucial Meeting

The non-profit National Kidney Foundation is refusing to release the final roster of the expert panel that meets in Dallas on Saturday to re-evaluate its anemia guidelines for people suffering from chronic kidney disease. Recent studies show that raising red blood cell counts to meet targets established in the 2006 NKF guidelines increases strokes and heart attacks for people on dialysis, and hastens the onset of dialysis for people with chronic kidney disease. Eleven of the 16 members of the committee behind those guidelines, which were underwritten by Amgen Inc., had ties to firms that sell drugs to alleviate anemia, which are Amgen, Roche and Johnson & Johnson. The government's Medicare program currently spends over $2 billion a year for these drugs.

The current roster on the NKF website lists 12 of 18 members with ties to those three firms. A spokesman for the group refused to answer questions about possible changes to the committee in the wake of recent criticism in The Lancet attacking both the guidelines and conflicts of interest in the NKF guideline-writing process. "We've decided to keep the membership anonymous," said Bryan VanSteenbergen, a spokesman for NKF.

In an article in the current issue of the Clinical Journal of the American Society of Nephrology, Daniel W. Coyne of Washington University School of Medicine in St. Louis blasted the committee's decision last year to ignore his own unpublished data showing excess mortality even though he offered the data from his industry-funded study to the committee. "In whose interest was it not to delay release of the guidelines until the results of these studies were available," he asked. In a written response, five physicians from the committee, four with ties to the drug makers, said reviewing only published studies "served as a safeguard against bias."

Coyne also attacked Medicare reimbursement policy, which rewards dialysis clinics for increased use of the drugs, and called on NKF to prohibit or "greatly limit" physicians with conflicts of interest from serving on its guideline-writing panels. "There are many physicians in academia with few or no ties to industry who are well trained to evaluate evidence from clinical trials and capable of writing guidelines," he told Integrity in Science Watch. "By not restricting corporate conflicts of interest among guideline panel members, the NKF has sometimes chosen physicians clearly favored by their sponsoring corporations, and effectively encourages those companies to attempt to influence all panel members." In the written response to his article, the NKF committee members said prohibiting physicians with conflicts from sitting on the panel "although attractive in theory, is unrealistic." They called instead for greater transparency.

Reprinted from today's Integrity in Science Watch.

Shaping the Health Care Debate

Ezra Klein of The American Prospect posted an interesting commentary on health care reform, and invited responses from a number of analysts (including me). Here's what I sent in:

We’re entering a period, like 1988-94, when everyone is for health care reform. The debate will center on what shape it should take.

I believe progressives should articulate a set of overarching goals, and evaluate any plan or incremental reform in light of those goals. Of course, compromise is inevitable. But it’s much more likely to lean in a progressive direction if there is a strong movement articulating core principles that are much broader than “universal health insurance.” Indeed, many universal health insurance plans have unintended consequences that will make our overall health care system worse and the payment system less fair, even if they succeed in eliminating the problem of the uninsured. I am especially concerned about individual mandate plans, whatever their shape, because they ultimately rely on some version of “consumer-driven” health care to hold down costs. This is a prescription for exacerbating the nation’s public health crisis, which already has us spending 40 percent more than any other advanced industrial nation yet delivering results that rank us 22nd out of 30 countries in the OECD.

Here’s my laundry list of goals, an attempt to redefine what is meant by Access, Affordability and Quality, which has been the mantra of health care activists for generations:

Access: We should demand access to health care for everyone when they get sick. That means universal coverage. But we should also demand that the universal insurer(s) support preventive care and launch public health campaigns around income inequality, stress, smoking, obesity, the food supply, environmental toxics, and the built environment—the factors that contribute to America’s ill-health. If you are among the healthy 50 percent of the population that accounts for just 3 percent of health care costs, you should be especially interested in delivering preventive care and public health campaigns to the 5 percent of the population that accounts for 49 percent of health care costs before they get sick. This is the only way to improve the overall health of the American people while effectively controlling costs.

Affordability: We should demand that the payment system be fair, i.e., it should be at a price that all people can afford, whether that comes from out-of-pocket payments, through taxes, or through the insurance system. And we should demand that the payment system be progressive. Those that can afford to pay more should, and those that can’t afford anything shouldn’t have to pay, with the rest of us strung out somewhere in between. Finally, we should demand that the health care system stop draining the rest of the economy, i.e., health care can’t continue growing at two to three times the rate of inflation without squeezing out other economic activities.

Quality: We have to redesign the health care delivery system so that it provides high quality care that is the best that medical science has to offer. That means grappling with issues like health information technologies, medical error, evidence-based medicine, and eliminating the perverse incentives of fee-for-service medicine. What it doesn’t mean is offering everyone Cadillac care since many modern technologies are the health care equivalent of 1959 Caddies: low mileage behemoths with ridiculous tail fins that aren’t necessary to get you where you want to go, which is better health.

Using this set of guiding principles, let’s evaluate recent developments, specifically, the Bush proposal to end the inequitable tax exclusion of employer-based plans. As Robert Reich points out in his single cheer for this proposal, it is the first step on the road to ending employer-based plans entirely, which everyone seems to be for these days, including Ezra Klein in his post. Yet Reich also calls for single-payer, which Ezra Klein says is unlikely to happen.

Has anyone thought through the implications of canceling the $700 billion or so paid out by private firms for their employees’ health insurance? The unfair tax implication of employer-based plans is reversed on the expenditure side. A company that provides a $10,000 insurance plan for a workers’ family is giving a 25 percent raise to the $40,000-a-year worker, but a 10 percent raise for a $100,000 a year worker. When they are in a common risk pool, each employee is treated the same. But if employers instead started giving cash grants to employees, how likely would it be that they give equal amounts to all rather than distribute it the way they do retirement 401-k contributions, which is based on salary?

So let’s say we’re only be for ending employer-based plans if we tax employers to replace the $700 billion they pay for their workers and families’ coverage. No cash grants to drive individual insurance plans allowed. How would we do it? Payroll taxes? Income taxes? And if we did that with employee matches, how would the incidence (who pays) of the new system compare to the current incidence of employer plan and individual co-pays? I find it curious that some people think moving to single-payer can’t be achieved because it would be too disruptive or would engender too much opposition. Is this any more disruptive than ending employer-based plans? Insurance companies take about $200 billion a year off the top of the $1 trillion in health care expenditures they manage (these are back of the envelope numbers). Ending employer-based plans requires raising $700 billion additional revenue.

Make no mistake, when the public finally starts paying attention to health care reform, they’ll be pretty smart about the details. Who pays will matter. Last week, I briefly attended the annual Families USA conference in Washington where I heard liberal economist Uwe Reinhardt, who is a very insightful and caring man (he also happens to sit on the boards of a hospital chain, an insurance company and a medical device maker). He called for taxing the upper third of income earners in this country to raise an extra $100 billion to pay for insuring the uninsured. That’s half a year’s expenditure in Iraq, he said to thunderous applause from the mostly progressive grass roots health care activists in attendance. But as the applause died down, I asked myself this question: Is that any more politically saleable than eliminating the insurance industry from the equation, which would provide more than enough money to get the job done?

Progressives need not worry about calling for single-payer because it’s “not a terribly likely outcome,” to use Ezra Klein’s phrase. Nor should they spend a lot of time trimming our sails (as long as proposals remain “scalable”) in the name of political expediency. My position is that we should build a strong movement for single-payer that is simultaneously fighting for quality health care and the overall health of the American people. In those debates, we’ll be taking on the drug, device and durable equipment makers, the diagnostic testing industry, hospitals and organized medicine, as well as the tobacco industry, environmental polluters, the food industry and other drivers of the dis-ease in American society. If we can’t get up the gumption to take on the insurance industry, how will we ever generate the political will to take on the real drivers of skyrocketing health care costs?

Connecticut Breaks Up Hospital "Secret Society"

When it comes to conflicts of interest, this blog focuses most of its attention on scientists. But they're not the only ones feeding at the trough. It turns out that some of the nation's leading hospital executives had formed a for-profit consulting group to advise hospital suppliers on how to get more sales from . . . you guessed it! . . . the institutions they ran.

It looks like their pocket-lining at the health care system's expense is coming to an end. Today's post on the Health Care Renewal blog highlights the Connecticut attorney general's fine and settlement agreement with the group that should bust up this "anticompetitive, secret society."

Speaking of conflicts of interest, I was stunned to learn today that Uwe Reinhardt, who downplayed health care cost control at this week's Families USA conference, serves on the boards of several firms that may not be all that interested in hearing a cost-control message. They are: Boston Scientific, Triad Hospitals, and Amerigroup. None of this information was disclosed in his last major article in Health Affairs, entitled "The Pricing Of U.S. Hospital Services: Chaos Behind A Veil Of Secrecy."

Now, it could easily be argued that an economist who serves on the board of directors of a hospital system like Triad hasn't being swayed by that affiliation when he writes a hard-hitting article attacking hospitals opaque pricing systems and how they "would have to be changed to accommodate the increasingly popular concept of 'consumer-directed health care.'" But isn't that something readers ought to decide, especially when two high-ranking Triad officials are thanked in the acknowledgements for their "constructive criticism" of the manuscript?

The Health Affairs author guidelines call for writers to tell the editors about their conflicts, and the editors "may" print it. I think that popular and prestigious journal should amend its guidelines to say "will" print it, because in this case, they definitely "should" have.

Prevention -- the Cure for High Health Care Costs

In case you missed it, David Leonhardt in yesterday's New York Times, had an important article highlighting the role that prevention must play in any health care reform. Let me highlight just two paragraphs:

It's important to note that the economic gains from preventive care are sometimes exaggerated. Sadly, the cheapest patients are often the ones who receive no care whatsoever, because many die before they reach their medically expensive golden years.

But the political case - the moral case - for prevention is unassailable. And to the extent that drugs and lifestyle changes replace surgery, rather than merely supplement it, preventive care can help pay for itself."

He should have placed lifestyle changes ahead of drugs, but otherwise, the point is spot on. That's why we need comparative cost-effectiveness studies to determine what health care interventions we should support. If we reimbursed physicians (or public health nurses) for prevention so we were paying them to get people to stop smoking and helping them to eat right and exercise insteady of paying high-priced surgeons to slice chests open, how much would it save? That's the kind of study the National Heart Lung and Blood Institute ought to be funding.

The Barack and Uwe Show

Presidential hopeful Barack Obama, the Senator from the great state of Illinois, made headlines today when he told the annual Families USA health care conference that we will have universal health insurance by the end of the first term of the next president. No clues as to his plan, though, which he promised "in a couple of months."

More interesting to me were the comments of Princeton University's Uwe Reinhardt, the doyen of health care economists, who followed Obama to the platform. The good professor kept the crowd of several hundred activists thoroughly entertained as he walked them through the absurdities of the Bush proposal, the inequities of the current insurance system, and the misplaced incentives of current health care tax policies.

For years, Reinhardt has been a leading voice for reining in the out-of-control health care costs by demanding accountability from providers of drugs, devices and diagnostic tests. He's also been a vociferous critic of the high prices in the U.S. system. In my book, I gladly credited him with coming up with the proposal, one of my key recommendations, that the government conduct comparative clinical trials so that it could scientifically justify decisions to eliminate pricey me-too drugs from government formularies (should it ever have the political will to establish them).

But I was struck this morning by how he seems to have thrown in the towel on cost-control. He's obviously still aware of the overpricing and overutilization imposed by providers. "What we call expenditures, they call revenues," he said. Yet he called for spending $100 billion a year to cover the uninsured, "half of what we spend a year in Iraq." The line drew thunderous applause from the crowd.

I also was surprised by his sanguine attitude toward the implications of throwing in the towel, which are that health care costs will double over the next decade (from $2 trillion to $4 trillion, making it 20 percent of GDP compared to 16 percent today). He compared that to the slower but still steady growth of the overall economy, which will grow from $12 trillion to $20 trillion over the same period. So while health care costs would grow by $2 trillion, the rest of the economy, though growing slower in relative terms, would still grow by $6 trillion. "I don't lose sleep over young people paying for Medicare," he said. "They can still pay for Medicare and have their Ferraris."

His preferred method for raising the money needed to pay for the uninsured: "Tax the upper third to pay for it."

Last week, Families USA, the preeminent lobby in Washington for uninsured poor families, joined forces with the insurance industry, the hospital association and other business groups to call for universal health insurance without spelling out a specific plan. Reinhardt applauded this new coalition. It's clear that there is an inside-the-Beltway consensus emerging that "we can get this done as long as we don't step on anyone's toes" and long-time fighters for health care reform like Reinhardt have joined in the chorus singing kumbaya.

So, all it will take to get universal health insurance is to keep Harry and Louise off the air by pouring a little more taxpayers' money into providers' coffers (and keep the insurers in the game). Sounds like the Medicare drug bill to me.

NEJM Weighs in on Guidelines

Robert Steinbrook, national correspondent for the New England Journal of Medicine, writes a "Guidance on Guidelines" that echoes the NIH protest last week that led to cancellation of the neonatal herpes meeting (for more on that story, click here). He concludes:

Clinical practice guidelines would serve patients and physicians best if they were prepared with the necessary financial and methodologic support to ensure their quality; the guidelines would inspire the most confidence if independent experts developed them without funding from industry or others with self-interest in the outcome. One approach would be to expand the NIH Consensus Development Program so that it could take on more subjects. Or Congress might require that the AHRQ once again support guideline development. Alternatively, the United States could create its own version of NICE, or a new agency to oversee and publish comparisons of the clinical effectiveness of different treatments and interventions. To succeed, however, any entity would need independence and financial security: when powerful interests take issue with guidelines, challenges will be inevitable.

Some Experts Dissect the Bush Plan

The Chicago Tribune's Judith Graham culled some interesting expert commentary that echoes my analysis:

Paul Fronstin, director of health research at the Employee Benefit Research Institute, envisions a series of serious consequences. More employers would stop offering health insurance and younger and healthier workers would opt out of company plans if they could get better deals elsewhere.

"This would be the end of employer-based health insurance as we know it," Fronstin said.

Robert Reischauer, president of the Urban Institute, worries that the president's plan would push more people into the individual insurance market, which is notorious for being expensive and excluding people with pre-existing medical conditions. "It's a jungle, and that's on a good day," he said.

Sherry Glied, chairwoman of the health policy department at Columbia University's Mailman School of Public Health, predicts that the president's proposal would have a "minimal" impact on the number of people without insurance. The vast majority of the uninsured pay minimal or no taxes, making a deduction of little value to them, she said.

What's Really in the Bush Plan?

After listening to the president last night and reading the press accounts this morning, it would appear that the first leaks of his health care proposal on Sunday were inaccurately described. Bush, according to this morning's New York Times, is proposing a standard $15,000 deduction ($7,500 for individuals) for health insurance, which means, I presume, he would make ALL health benefits taxable as income (to give a standard deduction and still leave plans under $15,000 untaxed would bankrupt the Treasury). So, if your employer-provided plan cost more than $15,000, you'd pay additional income taxes. If it cost less, you'd pay less (how much less would depend on the difference between your plan's cost and $15,000, multiplied by your marginal tax rate).

This changes nothing for the working poor who are uninsured. They are still being offered a tiny tax break compared to the cost of even a catastrophic insurance plan (one reader suggested to me that this is closer to $5,500 rather on average rather than the $8,000 I estimated Sunday). Okay, even if that's true on average, that's still three times more than the amount offered in the tax break. And it would do nothing for those folks who go to the emergency room on Saturday night with a sick kid for routine care. They'll still be socked with huge bills.

There's no doubt that making people aware of how much their employers are spending on their health care will sensitize people to health care costs. But it seems to me that it will still create all the perverse incentives that I outlined on Sunday if employers give their workers an opt-out option (take the cash and buy your own insurance). This will encourage the well-off, well-insured to switch to catastrophic plans, bank the rest in tax-deferred accounts and eviscerate the risk pool.

Which brings me to Steve Pearlstein's column in today's Washington Post, which he'll be on line to discuss live this morning at 11 a.m. I will skate over his ad hominem attacks on Sens. Ted Kennedy and Harry Reid and Reps. Pete Stark and Charlie Rangel, all of whom immediately called the president's proposal DOA (dead on arrival). "Labor dinosaurs" propagating "half-truths, unsupported assumptions and outright lies," he wrote.

What are those lies? It will do nothing for working families. It will increase the number of uninsured. And it will encourage everyone to buy less insurance than they need.

Even Pearlstein says it will at best encourage "a few million" to buy insurance from the 47 million who don't have it. What does he base that number on? And would that number, whatever it is, be larger than the number who would join the ranks of the uninsured when their employers drop coverage because of skyrocketing rates due to healthy people leaving the risk pool?

I think there is absolutely no doubt that this would lead to a shift toward catastrophic insurance plans. That's great if your healthy. But if you are among the 5 percent of the population that accounts for 49 percent of all health care costs (or are on the road to inclusion in that category because you smoke, are obese, eat poorly, fail to exercise, are under stress, have untreated hypertension, etc. etc.), those plans will cause you to stint on routine and preventive care and just make the overall burdens on the health care system worse. Economists who prattle on about "consumer-driven" medicine reducing unneeded health care costs -- and Pearlstein appears to have drank their Kool-Aid -- remain blissfully ignorant about the real drivers of rising health care costs in this country.

Mark Stanton of the Agency for Healthcare Research and Quality did an excellent paper last year on the distribution of health care costs. Anyone with the bully pulpit on health care reform (like a columnist for a major newspaper) ought to read it before engaging in ad hominem attacks on legislators who have been thinking about health insurance reform for decades. I'm not saying Pete Stark and Ted Kennedy are right about everything, but I believe an accurate understanding of the implications of the Bush plan lay behind their rhetoric.

Pearlstein called them on the carpet for demonizing the president and grandstanding, and asks, "Haven't we had enough of this?" Memo to Pearlstein: Look in the mirror and learn a few things about the health care system before you go running for your computer.

Pay or Play Under Attack

Pay-or-play health insurance schemes -- like Gov. Arnold Schwarzenegger's in California -- come under attack in the lead editorial in the Wall Street Journal this morning. Under pay or play, a company must either provide health insurance or pay into a state (or national) fund that can be used to provide the uninsured with health insurance.

The Journal points to the recent appeals court decision striking down Maryland's "Wal-Mart" law, which required companies over a certain size to provide health insurance. The ruling said the state legislature had ignored Erisa, the federal law that establishes national standards for corporate health and benefit plans, which are, the editorial emphasizes, supposed to be voluntary.

Like the Fortune 500 executive who wrote to GoozNews Sunday after my quick analysis of the Bush tax incentive plan, which will be unveiled tonight, there will be a lot of push back by the employer community against pay-or-play plans such as the Massachusetts-California plans and the recent offering from the Economic Policy Institute. Pay-or-play does nothing to relieve companies that provide insurance from its high and increasing cost, while forcing those who don't to either buy that insurance or pay a tax. All stick, no carrot.

One way to get around this is to relieve employers of their obligation entirely -- by moving to a single-payer system financed by a broadbased tax. That will create winners and losers among corporations (those who provide plans more expensive than the national plan), and make at least some of those winners proponents of reform.

The Bush Health Care Plan

In his State of the Union address later this week, President Bush will unveil a new health insurance tax break for individuals and families who purchase their own plans. He would simultaneously begin taxing the value of any employer-provided family plans that exceeded $15,000 a year ($7,500 for individuals).

The plan, pitched as taxing the well-off to provide help for the uninsured, is actually a carefully constructed scheme to further undermine the employer-based group insurance system. It provides a powerful tax incentive to encourage the well-off and healthy to abandon their employers' plans in favor of the Health Savings Accounts/individually-purchased catastrophic insurance plans favored by free market enthusiasts.

While the specific details remain to be seen, both today's New York Times and Washington Post said the plan's core element would provide a $15,000 automatic tax deduction to any families ($7,500 for individuals) who purchase their own health insurance. The plan would "pay" for this tax break by taxing as income any insurance plan offered by employers that exceeded those amounts.

Let's look at how this proposal might affect two different two-income families: one where both husband and wife earn $25,000 a year at lousy employers who don't provide health insurance; and the other earning a combined family income of $150,000 a year with a good health insurance plan that costs their employer under $15,000 a year. (With the average family plan now costing around $11,500, not many plans will fall into the taxable category; it will be interesting to see how the Congressional Budget Office calculates the tax revenue implications of the Bush proposal).

That moderate-income family without insurance will now get a $15,000 tax deduction if, and only if, they buy insurance. And don't forget, this is a deduction, not a credit. So, at their marginal tax rate of 15 percent, the tax break is worth $2,250. If they go into the marketplace and buy that "average" plan, their actual cost will be $9,250 or about $800 a month. Very few hard-working, moderate-income families without health insurance will find that incentive very attractive. If they buy a catastrophic plan, which provides hospital insurance only, it might cost only $8,000 a year. Even after the tax break, that's still nearly $500 a month. How many families bringing home $3,600 a month after all other federal, state and local taxes will opt for that?

Now, let's look at the $150,000 couple. Their employer plan, which costs their employer $11,500 a year for their family, is okay, but they're pretty tired from being shuttled between HMOs every year. Moreover, their employer this year began a new program: they can get a cash grant of $10,000 to buy their own insurance and/or put in a health savings account for routine medical expenses.

Over a cappuccino one night, the couple sits down and does the math. If they took $8,000 and bought a catastrophic insurance plan that covered any emergency hospitalization or life-threatening illness, they could put the other $2,000 in their tax-deferred health savings account to pay for routine medical bills. Given the fact that they're healthy (knock on wood) and the kids' care is routine, that's more than enough to pay the bills.

On the tax side, their total income from their employer goes up by $8,000 (the other $2,000 in the HSA is tax-deductible, don't forget). But that is more than offset by the $15,000 tax break, leaving a $7,000 tax deduction. At their tax bracket of 28 percent (as with the home mortgage deduction, health care deductions are worth more to those who earn more), that puts an extra $1,960 in their pocket at tax time.

You don't have to be a rocket scientist to figure out that this proposal provides a powerful incentive for healthy, well-off families to abandon their employer plans if their employer gives them that option. And employers will increasingly want to do that since it will save them money: the cash grants will always be less than the cost of insurance. Indeed, as more and more well-off, healthier families opt for the grants, only the sickest and most costly employees will remain in the insurance pool. This will drive the cost of regular insurance higher and further erode employers' willingness to continue paying for it.

It's hard not to conclude that this plan was carefully designed to put another nail in the coffin of the employer-based health insurance system, and build upper-middle-class support for individual families purchasing their own plans and care. It has nothing to do with insuring the uninsured, since the benefits are far less than what is needed to effectively move them into the insurance pool.

Looking for an Honest Broker in Health

Many physicians and hospitals in the U.S. ignore the best scientific evidence when treating patients, which helps explain why we have worse health care outcomes than other advanced industrialized nations despite spending far more. Any proposal for universal health care that wants to improve quality must include powerful incentives for moving the health care delivery system toward adopting evidence-based medicine.

It's not only key to better health care, it's the key to making health care affordable. The marketing muscle of medical suppliers like the drug and device companies encourages physicians to follow the most expensive medical practices, which often turn out to be worse for health than cheaper alternatives. Therefore, if insurers, whether Medicare or the private market, paid doctors to perform up to scientific standards (it's called pay for performance), not only would the health care system's performance improve, it would be less costly.

The key, of course, is coming up with evidence that identifies the most effective forms of prevention and medicine. Someone -- the National Institutes of Health is the most logical candidate in the U.S. -- must conduct systematic studies that compare competing modes of prevention and treatment to determine which are the most effective interventions. Just as importantly in the cost-constrained years ahead as the Baby Boom ages, someone is going to have to figure out the most cost-effective interventions. These comparative studies, distilled into evidence-based clinical practice guidelines, will be the building blocks of any new universal health care insurance system if it is going to provide quality care to everyone at a price that the rest of the economy can afford.

But where does this evidence come from? The gold standard for evidence-based medicine is derived from randomly-controlled clinical trials. When there are few trials to go by or they cannot be randomly controlled (many implanted devices or othe surgical procedures fall into this category), the evidence comes from observational studies. In a few cases, like for extremely rare diseases, the evidence comes from consensus statements issued by docs who have tons of experience in the field.

This collective wisdom is synthesized into clinical practice guidelines, which are issued by government agencies, medical professional societies and even patient advocacy organizations. These groups call together panels of physicians (sometimes they include patient representatives) to review the evidence, and distill from them a set of best practices that physicians should follow. The assumption is that by widely publicizing these guidelines (the Agency for Healthcare Research and Quality has even created a website that collects them and makes them readily accessible to physicians, patients and payers) and providing incentives for their adoption like paying doctors to adhere to them, the quality of health care in the U.S. will improve.

But for many health care observers, the questions immediately raised by efforts to move toward evidence-based medicine are: 1) How valid is the evidence and who paid for the research (we know that research sponsored by industry usually favors the sponsor's products); and 2) who evaluated that evidence.

Those were the concerns that lay behind this week's protest against a relatively minor meeting at the National Institutes of Allergy and Infectious Diseases that had been called to write clinical practice guidelines for the diagnosis and treatment herpes in pregnant women who are at risk of passing the infection to their newborn. Four of five presenters at the February meeting had financial ties to GlaxoSmithKline or a Glaxo-funded "patient advocacy" group. Glaxo makes a drug, Valtrex or valacyclovir, that suppresses herpes outbreaks. Shortly after receiving the protest letter, NIH cancelled the meeting.

While potentially devastating to the baby, neonatal transmission is a relatively rare phenomenon -- under two thousand cases a year. If a pregnant woman has herpes (and about one in five do), then careful monitoring to ensure there is no outbreak at the time of delivery can avoid the problem. If there is an outbreak, the usual treatment is delivery by cesarean section. While avoiding C-sections is desirable, the number of women getting this procedure at birth is already nearly 30 percent of the 4 million births each year. Does it really make sense to expose newborns to heavy doses of antiviral medications whose long-term health effects are unknown in the name or preventing a few thousand more C-sections?

But, as a Wall Street Journal story documented last month, Glaxo has launched a nationwide "education" campaign to convince doctors to test all pregnant women for herpes, since, once confronted by this "problem," many doctors would probably prescribe drugs to suppress an outbreak. The education program has been accompanied by a large-scale direct-to-consumer advertising campaign for the drug. Once the speakers for the NIAID's neonatal herpes guideline-writing conference in February were announced -- four or five had ties to Glaxo -- it quickly became apparent that Glaxo's marketing campaign had infiltrated that process, too.

The physicians signing the protest letter were a fairly high-powered group. They included Richard Horton, editor of the Lancet, which ran an article last fall critical of the herpes screening in pregnancy; two former editors of the New England Journal of Medicine, Marcia Angell and Jerome Kassirer; and 41 other physicians and scientists, including the head of the U.S. Cochrane Collaboration, which is an international consortium that writes clinical practice guidelines free from industry influence. As their letter pointed out, virtually every clinical practice guideline that comes out of NIH these days -- the examples cited in the letter included guidelines for hypertension, cholesterol management and pediatric AIDS -- has a majority if not a preponderance of physicians with ties to industry.

The letter also pointed to recent examples highlighted in the medical literature (Amgen's Epogen for anemia and Eli Lilly's Xigris for sepsis) where clinical practice guidelines written by physicians with ties to the drugs' manufacturers had actually increased mortality because the drugs touted in the guidelines were being used inappropriately. "Why should either practicing physicians or patients have faith in guidelines written by researcher-physicians with ties to providers whose financial well-being is driven by the content of those recommendations?" the letter asked.

The coalition asked NIH to adopt a simple agency-wide rule: Any institute or center at NIH that writes or funds a group to write a clinical practice guideline should require that the writing committee exclusively be composed of members without conflicts of interest. And those committees should seek out the full range of evidence on a subject before sitting down to write."

The stakes here are much broader than the best treatment for preventing transmission of neonatal herpes. NIH, the letter writers said, "must serve as an honest broker in the development of medical evidence that will inform clinical practice."

An NIH spokesman late Friday afternoon said the agency was still evaluating the broader demands contained in the letter, demands that have significant implications for the future of the movements for evidence-based medicine and pay-for-performance. But a high-ranking NIH official earlier in the day provided a hopeful sign that the agency may respond positively to the criticism.

If you haven't guessed already, I wrote the letter behind this campaign and, in my role as director of the Integrity in Science project at the Center for Science in the Public Interest, organized the physician-consumer coalition that sent it to NIH. After hearing late Thursday night that NIAID had canceled the herpes meeting, I decided to celebrate by taking the morning off to attend a symposium sponsored by the journal Health Affairs on "Heart Disease Prevention and Treatment."

Much of the discussion revolved around the cost-effectiveness of treatments, which isn't surprising since the journal focuses on health economics. David Cutler of Harvard argued that virtually every intervention is cost-effective and he looked forward to lots more coming out of the drug and device industries. As counterpoint, Thomas Gaziano, also of Harvard, pointed to the latest cholesterol guidelines, a product of the National Heart Lung and Blood Institute at NIH where 8 of 9 physicians had ties to statin manufacturers. Their proposals, if widely adopted, would result in spending $2 million on statin drugs for every quality-adjusted life year (QALY) improvement, which is far above the generally accepted standard that says anything over $50,000 (or $100,000 in some formulations) is not cost-effective.

That provided me with a perfect opening to jump up and ask Elizabeth Nabel, the director of NHLBI, who was also on the panel, why the medical economics literature lacked comparative effectiveness studies comparing various drugs for a single conditions or drugs versus other health care interventions, or, for that matter comparative cost-effectiveness studies. I also asked if NHLBI would be willing to fund such studies. She replied: "We see ourselves as clearly being the honest broker to provide the data to support evidence-based medicine."

Though she wasn't one of the recipients of the letter, I thought her choice of words was instructive. Sometimes building an honest broker must be done one brick at a time.

NIH Cancels Neonatal Herpes Meeting

I received a phone call tonight from one of physicians who signed the letter protesting the National Institutes of Health neonatal herpes conference because of flagrant conflicts of interest among the presenters. Apparently, the top brass at NIH has canceled the meeting. If this turns out to be accurate, the question becomes: What will the agency's policy be for future clinical practice guideline writing committees? Will they require that all such committees be free of ties to companies with a stake in the outcome?

NIH Blasted for Conflicts of Interest

The Center for Science in the Public Interest knit together a coalition of more than 40 top physicians and over a dozen consumers groups to protest an upcoming meeting at the National Institutes of Health on how to prevent mother-child transmission of herpes. Four of five presenters at the Feb. 20 meeting have financial ties GlaxoSmithKline, which makes the anti-herpes drug Valtrex. The protesters are calling for NIH to forbid scientists with such blatant conflicts of interest from sitting on committees that write clinical practice guidelines. When such guidelines come from NIH, they're generally given a lot of weight by the medical profession.

Signers of the protest letter included Richard Horton, editor of the Lancet, and former New England Journal of Medicine editors Marcia Angell and Jerome Kassirer. A number of women's health organizations also signed onto the letter. You can read the press release and the letter here.

AHRQ Blasts Off-Label Use of Anti-Psychotics

The Agency for Health Research and Quality issued a press release yesterday saying there is no evidence to support many off-label uses of atypical antipsychotics.

No Consensus Without the Supply Side

A kind relative gave me the Far Side desk calendar as a present this holiday season. This morning's cartoon shows a number of people crowded into an elevator along with a lion. We see the lion's rear through the door, which is about to close on the lion's tail. His owner is petting him softly. Caption: "Don't be alarmed, folks -- he's competely harmless unless something startles him."

Perfect cartoon for the headline in this morning's Washington Post announcing "a new consensus on universal health care." The column by Steven Pearlstein reported on the press conference held yesterday by the heads of the Business Roundtable, the AARP and the Service Employees International Union, the nation's largest union of health care workers. "Now is the time" for universal health care, says Andy Stern, president of SEIU.

According to the Wall Street Journal report on the press conference, this new coalition didn't lay out a specific plan. I'm sure the insurance industry-led coalition that includes advocates for low-income families like Families USA will be more specific when they lay out their plan either later this week or next week.

However, Pearlstein did offer his own vision of what a Business Roundtable/AARP/SEIU plan might look like, and it looks a lot like the Schwartzenegger plan in California. Given the prominent top-of-the-fold coverage given the column, I think I know where the inside-the-Beltway consensus is going. "All of the major interest groups would have to make important concessions," Pearlstein wrote.

But he, like Schwartzenegger, seem either unaware or politically naive about the hidden controls and levers that special interests wield over the health care system. Just one example: Pearlstein says doctors would have to agree to have their compensation tied to how well they conform to treatment protocols established by medical specialties. But he doesn't address who wrote those protocols, and how many of them reflect not the best health care but the financial interests of companies or physicians providing products or services for that condition.

It was a classic newspaper picture, the perfect photo op: business, labor and seniors together. All of them want universal health care. Think of them as the nice people in the elevator. Then, picture the lion and think of the insurance industry, the drug, device and durable equipment suppliers, the hospitals, and organized medicine.

Bad Timing

Pfizer plans to announce more cutbacks next week, including flat-lining the company's R&D division, the Wall Street Journal reports this morning.

Pfizer's big failure on a new cholesterol-lowering drug; only 17 new drugs for the entire industry last year; large cuts among drug reps; stock prices down, profits flat: hardly the picture of an industry at the top of its game. Makes a tougher target for drug industry critics on Capitol Hill, where safety legislation and reauthorization of the Prescription Drug User Fee Act top the agenda.

MLK on Health

"Of all the forms of inequality, injustice in health care is the most shocking and inhumane."

--Martin Luther King Jr.

Unattributed quote, according to Wikipedia

Posted by gooznews at 10:57 PM