Scanning for Dollars

The front page of the New York Times this morning has a don't miss article on the financial incentives behind using CT scans to look for heart disease. Medicare's decided in March to begin paying for the test despite no evidence that it saves lives (see this GoozNews post). The lobbying campaign by a newly created physicians guild that invests in CT scanning clinics is discussed in the last few paragraphs of the story. That campaign was aided by "entrepreneurial guidelines" touting the procedure, discussed in this GoozNews post.

Here are the two key quotes from the story:

"It's incumbent on the community to dispense with the need for evidence-based medicine."

--Dr. Harvey Hecht, Manhattan cardiologist and CT scan advocate

"There are a lot of technologies, services and treatments that have not been unequivocally shown to improve health outcomes in a definitive manner."

--Dr. Barry Straube, chief medical officer, Medicare

Alas, the article does not clearly describe the option that Straube and the Center for Medicare and Medicaid Services rejected in agreeing to pay for the scans. During Mark McClellan's tenure at the agency, he instituted a "coverage with evidence development" program. That in-between option would require physicians using heart CT scans to send in results and monitor their patients over time, sending that follow-up data into the agency, too. This would create a database that could be analyzed to see if CT scans for heart disease and subsequent follow-up care actually reduced the incidence of heart disease mortality.

"We didn't need to be talking about registries and the research," said Daniel S. Berman, president of Society of Cardiovascular Computed Tomography, a society of 4,700 physicians whose sole purpose is to promote CT angiograms, according to the article.

We don't need no stinkin' evidence. We don't need no stinkin' registries. We don't need no stinkin' research.

New leadership at CMS in the next administration at a minimum must insist on creating electronic registries for every new technology that it pays for where there is not yet clear cut evidence that it works. It also should set firm deadlines for manufacturers to submit well-controlled clinical trials offering definitive proof -- or the payments authorized under the coverage-with-evidence-development policy should be revoked.

Book Reviews by Goozner

Readers with access to either Nature or New Scientist magazine may be interested in these reviews that I wrote. One was of a new book by Stan Finkelstein and Peter Temin called Reasonable Rx, where the physician-economist team called for a breakup of the pharmaceutical industry into separate manufacturing and R&D parts. And the other was of David Michaels' Doubt Is Their Product and Thomas McGarity and Wendy Wagner's Bending Science, which skewer corporate campaigns to undermine sound science.

Here's the lead to the latter review:

REAL science depends on the dispassionate search for truth, said sociologist Robert K. Merton a half-century ago. To claim the mantle of scientist, a researcher must be divorced from preconceived bias or monetary gain, and the work should be subjected to the rigorous scrutiny of a community of peers. At the height of the cold war, Merton's coda provided a ringing defence of Enlightenment values.

But by the time Merton articulated those ideals, the tobacco industry had already set in motion a pseudoscientific strategy that threatened to undermine them. Big Tobacco's advance guard created a non-profit institute, hired scientists and commissioned papers with a single purpose in mind: to cast doubt on what would soon become a flood of evidence proving that smoking kills.

It worked. Public campaigns to combat smoking were delayed for decades; regulation was forestalled. . .

Rx Industry Marketing in the News

A couple of major stories yesterday took aim at the drug industry's direct-to-physician marketing. BusinessWeek reveals how several doctors "routinely" failed to tell their patients about payments they took from Pfizer while prescribing Chantix, the company's smoking cessation drug. CBS News uses the death of a pre-teen girl who'd been prescribed Zoloft for minor anxiety to highlight the parents' anger that they had never been told their doctor was taking payments from the manufacturer, also Pfizer.

Both stories touted Sen. Charles Grassley's Physician Payments Sunshine Act, which would require that any payment to physicians greater than $500 be reported on a publicly available database. I'm all for it, but ask yourself this: next time you're at your doctor and he/she prescribes a drug, are you going to go online to look up whether they took money from the manufacturer (first you may have to look up the name of the manufacturer, since that is usually not clearly marked on the prescription or the label) before filling that prescription? And if they did, will you not fill it?

The estimated cost of direct-to-physician marketing has now reached $57 billion annually, according to the story (this is taken from a recent estimate that appeared in PLoS Medicine). It's not just direct payments, it's advertising, journal reprints, free samples, trade show exhibits, a sales force (about 90,000 reps at its peak) that alone must cost $10 billion a year in salaries.

Transparency is good. But wouldn't a total ban on such payments and tighter restrictions on the rest be better?

Rejuvenating Public Sector Science

The following is reprinted from Common Dreams.org:

by Kirsten Stade

Budding young scientists are taught that the nation's
scientific enterprise reflects an unblinkered search
for truth, conducted by dispassionate researchers
divorced from preconceived bias or monetary gain. Alas,
in the real world, far too many scientists have hired
themselves out to the highest bidders - corporate
interests that use their science-for-hire papers to
cast doubt on the facts that our planet is warming,
smoking kills, and toxic chemicals can cause birth
defects.

In recent years, these ongoing campaigns to stop
regulations that would reduce carbon emissions, clean
up our food, air and water, or control tobacco have
been joined by a war on government-funded science
itself, targeted against scientists who work to promote
public health and a cleaner environment. Budgets have
been slashed. Good scientists have been turned into
whistleblowers because their global warming reports
have been quashed, their clean air analyses ignored and
their species protection plans shelved.

In the health care arena, where skyrocketing costs are
the primary reason 50 million Americans do not have
insurance, drug and medical device companies have
staged a money-driven friendly takeover of the practice
of medicine. Physician-researchers on industry's
payroll publish papers touting the latest pills or
technologies based on flimsy or no evidence, and then
write a clinical practice guideline suggesting the new,
pricier technology ought to be used. Then some of these
very same researchers hide their conflicts of interest
when publishing in the medical literature, all to
further their and their sponsors' bottom lines.

Fortunately, the tide is beginning to turn on this
corporate-driven war on science. Laws have been
proposed that would protect government scientists who
blow the whistle. Congressional investigations have
exposed administration efforts to silence scientists
and uncovered hidden drug industry payments - such as
those to the psychiatrists who were responsible for
promoting anti-psychotic-drug use in thousands of kids.
Laws have been proposed to eliminate conflicts of
interest on federal advisory committees.

This progressive counteroffensive in the war on science
will be highlighted at the fourth national Integrity in
Science conference on July 11 in Washington, sponsored
by the Center for Science in the Public Interest. This
year's theme, 'Rejuvenating Public Sector Science,'
will illuminate a path out of the current morass. Only
by bolstering the resources available to government
agencies charged with protecting public health and the
environment and affirming their authority to do their
jobs can industry's efforts to undermine sound science
be defeated.

The conference will feature award-winning climate
scientist James Hansen, who heads the NASA Goddard
Institute for Space Studies and who was the first to
focus global attention on the growing urgency of the
climate crisis when he testified before a Senate
Committee in 1988. Hansen is recognized as one of the
world's foremost authorities on the need for immediate
action to avert climate disaster, and can attest to the
powerful forces that have fought to keep his message
from reaching the public.

In addition to Hansen's talk, other panel sessions will
focus on insulating alternative energy research from
industry attacks, protecting scientist whistleblowers
from retribution, enforcing rigorous conflict of
interest disclosure policies by scientific journals,
and restoring scientific integrity to government
agencies entrusted with conservation of wildlife and
natural resources. Congressman Brad Miller, Chairman of
the Subcommittee on Investigations and Oversight of the
House Committee on Science and Technology will speak on
'Preserving Scientific Integrity: The Role of
Congressional Oversight.'

The conference begins at 9:00 am on July 11, 2008 at
the Ronald Reagan International Center in Washington,
DC. Register and see the full agenda at http://cspinet.org/integrity/conflictedscience_conf.html.

Science and the rationality it brings to government
decisionmaking has a crucial role to play in solving
the climate, energy and health care crises. CSPI's
Rejuvenating Public Sector Science conference will be
of interest to anyone interested in helping to put
these issues squarely on the agenda of the next
administration.

Kirsten Stade manages the Integrity in Science Project
at the Center for Science in the Public Interest.

Health Wonk Review

The new Health Wonk Review is up at Disease Management Care blog. Check it out!

When Late Is No Better Than Never

The special interest feast that is Medicare legislation gets its day in the media sun today after the House overwhelming passed a bill whose primary aim is to keep physician payments level instead of forcing them to absorb scheduled cuts. The bill also eliminated a proposed competitive bidding program for medical durable equipment that could have saved the agency billions of dollars annually.

That giveaway drew condemnation from the New York Times' editorial page and economics columnist David Leonhardt. Alas, where was the paper of record when some good folks up on Capitol Hill were trying to role back this rip-off of the senior citizen health care program?

The Hill broke the story in early May; I blogged about it here. A little attention from the MSM (mainstream media) over the last month-and-a-half would have helped. The Washington Post, the Wall Street Journal, and USA Today, my other morning reads, failed to even mention the story, while local papers like the Cleveland Plain Dealer rushed in to report the "success" of local companies who overcharge the system.

Major news outlets need to rethink their roles in an era when news has become an ubiquitous commodity and the Internet has made immediacy the coin of the realm. Editorials and columns are here today, gone tomorrow, and are largely irrelevant when they come after the fact. The media's ability to conduct extended investigations are fast disappearing (when was the last time you saw a five-part series in a daily paper?).

The only way for newspapers (or news websites and blogs that employ full-time journalists) to be relevant in the Internet era is to take up causes. Bring back crusading journalism! If there is an obvious injustice out there, especially one involving special interests ripping off the public purse, the way to counter their power is to hammer away day after day at the issue. What good does it do to let us know the day after the vote that Congress sanctioned another giveaway? And if you're a local paper, take on those special interests, even if they're from your home district. A few local jobs are not worth the larger costs to society.

Hoist on His Own Petard

Every once in a while, something appears in the press that make me laugh out loud because of its mistakes and contradictions. Today's column by Scott Gottlieb in the Wall Street Journal achieved that dubious distinction.

The column's core claim was that Congress in its annual reauthorization for Medicare is trying to turn medical decision making over to the "bureaucrats" at the Center for Medicare and Medicaid Services by cutting excess payments to Medicare Advantage plans, the insurance industry's answer to senior citizen health care. Congress launched the Medicare Advantage experiment in 2003 by giving its sellers a 13 percent increase over the costs of traditional Medicare.

And as a result, Gottlieb tells us, Medicare has just "20 doctors and 40 total clinicians (including nurses)" making coverage decisions, while private insurers "employ thousands of doctors, nurses and pharmacists, many experts in new technologies."

I thought to myself: What a miracle! Medicare with significantly less overhead has created a system whose overall costs rise at about the same rate (and sometimes slower) than private insurance, while it consistently maintains higher satisfaction rates in surveys of its users.

Thanks Scott! You just made THE central argument that favors making Medicare the default plan for covering the uninsured.

Then we're told that a recent Price Waterhouse Coopers survey showed that private plans spend four times more than Medicare on "consumer services, provider support, and marketing." Medicare would need to hire 4,500 clinicians to keep pace with the effort private insurers pour into "answering the telephone to adjudicate individual issues."

Isn't it possible that all those people calling private plans are asking why they were turned down for coverage? Or are they wondering if something will be covered? And since Medicare doesn't have such people, doesn't that suggest that Medicare doesn't generate the same level of complaints and queries? My mom, who passed away in April at age 86 (Gottlieb used a friend's dad as his sole anecdote, so I feel comfortable getting personal here), went through six years of declining health and was under constant physician supervision. Over that entire time period, the only coverage questions our family had involved the private drug plan she used.

Again, thanks Scott! Chalk up another argument for Medicare for All.

Next he complains that Medicare doesn't have a single oncologist on staff, yet its rules include 165 "restrictions" on the use of cancer drugs and diagnostic tests. As my teenage daughter would say, "hellooooo."

Did this blog not just cover the fact that Medicare has radically expanded its authorization for use of cancer drugs by putting off-label decision making in the hands of compendia writers in the private sector, many of whom are on the payrolls of the companies that make the drugs? Aren't cancer drugs the fastest rising component of Medicare spending, slated to nearly double by 2015? When I talk to oncologists (and I frequently do), what I hear about is the rapidly rising cost of drug co-pays for their patients, not about restrictions on the marginally useful products coming out of industry's labs.

The column concludes by returning to its original agenda: Congress is moving to cut the Medicare Advantage plans' 13 percent bump over traditional care, which proponents claim goes to pay for extra "benefits." As Scott so amply demonstrated earlier in the column, those aren't benefits, those are insurance industry costs.

Medicare (Dis)Advantage is proving day by day that it cannot compete with Medicare on costs, on service, or on customer satisfaction. The solution is easy. Level the playing field, Dr. Congress, and let the marketplace decide. And thanks Scott for giving them all the ammunition they need to argue their case.

Testing Drugs on Vulnerable Vets

Last week, ABC News and the Washington Times reported that hundreds of veterans with post-traumatic stress disorder (PTSD) have been enrolled in Department of Veterans Affairs (VA) studies testing smoking cessation drugs, with 143 of these veterans taking Chantix, a drug that has been linked to severe psychiatric symptoms (see posts here, here, and here. The veterans are paid $30 a month for participating.

According to the ABC News/Washington Times report, the VA became aware in November that Chantix had been linked to psychiatric side effects, but waited over three months to notify the veterans of the potential danger. Late last week, the VA disclosed that 26 Serious Adverse Events (SAEs) had occurred during the Chantix study, including 10 of a psychiatric nature.

The ABC News/Washington Times story describes the case of James Elliott, a decorated Army sharpshooter with PTSD who started taking Chantix in November and soon started experiencing hallucinations and suicidal thoughts, unaware that Chantix might be causing them. In February, Elliott was tasered by police who were called to his home after he became confused and psychotic. "Lab rat, guinea pig, disposable hero," said Elliott in describing how he felt he was treated by the VA.

Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said the VA's behavior violated basic protections for humans in medical experiments. "When you're taking advantage of a very vulnerable population, people who have served the country, and the agency that's responsible for their welfare isn't putting their welfare first, that's a pretty serious breach of ethics," he said.

Caplan, who reviewed the consent and notification forms for the study at the request of the Washington Times and ABC News, said the VA deserved an "F" and that it has an obligation to end the study, given the vulnerability of veterans with PTSD and the known side effects of Chantix. "Continuing it doesn't make any ethical sense," he said.

Late last week, the VA announced that the study would continue but that it would send a letter to all 32,000 veterans who are taking Chantix, warning them of possible side effects, including suicidal thoughts and behavior. "Our first responsibility is to our veterans," said Veteran Affairs Secretary James Peake, who said he has asked VA doctors to review "the communications process" involving all VA studies using veterans who are suffering from PTSD.

-- PM

In Praise of Homeownership

In the wake of the sub-prime mortgage meltdown, it has become fashionable to remind people that homeownership isn't for everyone. Last Friday, I listened to a report on NPR from Wheaton, MD, which is only a few miles up the road from my home, where a hard-working Hispanic woman was being thrown out of her house bought for just under $400,000 near the top of the bubble. The details were both depressing and anger-inducing: the unscrupulous mortgage lender had qualified this single mom for a teaser-rate loan by including the money she would earn from renting out her basement to itinerant laborers.

But what really got to me about the story was the few comments from her teenage son. He worked hard around the house, planting flowers, and keeping the exterior in good repair. Like his mom, he also wanted a part of the American dream.

I see it every time I drive through Wheaton (to get to my daughter's high school, the golf course, or the local shopping mall). The tiny bungalows that are owned are easy to spot. So are the rentals because paint is peeling and their lawns unmowed. Pride of ownership matters, especially in the older, inner-ring suburbs that make up the bulk of housing for America's lower middle-class.

It also caused me to think back to my own first experience in home ownership. It was the mid-1970s, I was working as a printer at the afternoon newspaper in Cincinnati, had one child with another on the way. My wife and I were both trying to finish college while working and raising a family. With the help of a government-financed mortgage and the home mortgage deduction (without which the interest rate made me unqualified for the loan), we took a run-down inner-city home that had been converted into a three-flat in the 1950s and restored it to its original purpose.

We were part of the first wave of gentrification in America's cities. And whatever one thinks about the displacement that accompanied that phenomenon, returning young families were a boon for cities. The phenomenon would not have been possible without federal programs that support home ownership.

Every time I return to Cincinnati to visit my son (I was last there in May to receive a Distinguished Alumni Award from the University of Cincinnati), I make a point to drive through the old neighborhood. It's still well-painted, with its tiny postage-stamp front laws well-kept. And best of all, there were still a clutch of small kids, black and white, playing on its streets.

Home ownership is not an "obsession," as Paul Krugman describes it in his column today in the New York Times. It is the bedrock on which community stability is built in America. Homeownership makes neighbors come together to maintain local schools, local streets, improve the local business district and highlight incidents of crime to make sure things aren't getting out of control.

Has it exacerbated sprawl by subsidizing new home construction far from cities? Absolutely. But there are better tools to deal with that issue. Zoning restrictions, agricultural land protection, and removing road-building subsidies directly tackle that problem. Removing home ownership subsidies is a blunt instrument for dealing with sprawl.

It is frequently argued that the home mortgage deduction is unfair. The higher the cost of one's house and mortgage and the higher one's tax bracket, the larger the subsidy. Again, if equity is the goal, then these problems can be fixed by either capping the value or indexing its level based on income, not removing it entirely.

As I drive around my neighborhood, which is near two mass transit stops and is in an older inner ring suburb outside Washington, I see dozens of townhomes being built on land that had been deemed unsuitable for building when the first wave of home-building swept through this area in the two decades after World War II. This is the classic in-fill housing, precisely the kind of construction that will be needed in the next several decades as America, and the rest of the world, deals with the global warming crisis.

Congress should crack down on unscrupulous lenders, of course. It should rebuild systems for protecting novice homeowners when they enter the home mortgage market for the first time. They could even tinker with the home mortgage deduction to make it more fair.

But home ownership is still the best way for young families to build personal and community equity in our society. The recent excesses of the market shouldn't blind us to that enduring reality.

BMJ Takes on Key Opinion Leaders

This morning's British Medical Journal slams the drug industry's practice of hiring "key opinion leaders" among academic physicians, whose job is to promote sales of individual products with company-dictated presentations to practicing physicians. Australian journalist Ray Moynihan includes a revelatory interview with an 18-year veteran drug representative, who candidly admits "if that speaker didn’t make the impact the company was looking for, then you wouldn’t invite them back."

To read the interview, and see a video clip, click here.

Taxing Cigarettes Reduces Heart Disease

(HBNS) -- If more states introduce tobacco control programs for their residents who are regular smokers, the number of U.S. deaths due to coronary heart disease might drop, finds a new study that looks at an ongoing Massachusetts initiative.

A connection exists between coronary heart disease and cigarette smoking, and the new study determines how a reduction in smoking affected the number of related deaths in Massachusetts between 1993 and 2003. The state introduced its Massachusetts Tobacco Control Program (MTCP) in 1992, which received funding through a special cigarette tax, and the researchers say they expected to find it helped control the rate of smoking.

“California was the first state to have a statewide program like the MTCP and they witnessed substantial declines,” said lead author Zubair Kabir, who at the time of the study was a research fellow at the Harvard School of Public Health. “So it was not surprising that Massachusetts, the second state, would see such declines as well, which reflect the impact of a comprehensive, integrated and — at the time — well-funded program.”

The study appears in the August issue of the American Journal of Public Health.

Kabir and his colleagues examined data from daily smokers ages 25 to 84. They found that between 1993 and 2003, coronary heart disease mortality declined 31 percent — from 199 deaths to 137 deaths per 100,000 persons each year. Smoking prevalence declined from 20.5 percent to 14.5 percent

Based on these results, the researchers calculated that 425 fewer coronary heart disease deaths were attributable to decreased smoking during the 10-year period. They concluded that expanding comprehensive tobacco control programs, such as MTCP, to other states could avoid more tobacco-related disease deaths.

Audrey Ferguson, health promotions manager at the American Lung Association of Indiana, agreed with the authors’ conclusion.

“The American Lung Association strongly supports comprehensive statewide tobacco control efforts, including increased tobacco taxes and smoke-free workplace legislation,” she said. “We recognize that tobacco use does not affect just the lungs or the heart of the tobacco user. Everyone would see health benefits from a comprehensive tobacco control plan.”

The MTCP was not immune to roadblocks, however. According to Kabir, budget cuts stalled state funding for the program in 2002, but it is now active again.

Nevertheless, he added that, “Although funding has risen somewhat since 2002, now around $12 million per year, it is nowhere near the levels seen at the height of the program in the late 90s.”

Feel Good Column of the Day

The revival of the musical South Pacific had a big night at the Tonys, and Harold Meyerson, executive editor of The American Prospect and columnist for the Washington Post, had a wonderful column this morning putting both the original version, which ran for five years on Broadway in the late 1940s and early 50s, and its current incarnation in their proper political contexts. In short, its racial themes had much to say about a soon-to-change America then, and (hopefully), our soon-to-change America now. Read and enjoy.

Just one thought before you do, though. Broadway was at the heart of American culture in the early 1950s. Let's hope that the current South Pacific revival isn't an Off-Off-Broadway production, relevant only to those who find their way to the theater house.

Industry-Funded Think Tank Organizing for Preemption

A correspondent from Harvard warns that deregulatory zealots affiliated with the conservative American Enterprise Institute are circulating an unidentified amicus brief in the Supreme Court case of Wyeth v. Levine, which will be heard next fall and could result in federal drug regulations preempting state product liability laws. If the court rules in favor of Wyeth, it would remove the public's right to file suit in state courts whenever the Food and Drug Administration fails to protect consumers from unsafe drugs, such as happened in the Vioxx, Trasylol, Paxil and all too many other cases.

According to the brief's abstract:

Fundamental principles of economics and numerous studies of FDA drug regulation reveal that FDA in fact errs on the side of overregulation of prescription drugs. Product liability litigation focused solely on one side of the prescription drug public health equation leads to further distortions of the drug approval and labeling process and exacerbates FDA's inherent overly cautious approach. Preemption of state tort law where it conflicts with FDA requirements will minimize these distortions and thereby maximize public health.

The brief's authors are seeking additional signatories from the academic community. The lead author is John Calfee, who isn't identified on the brief, but is a drug industry-funded scholar at AEI. Another author is Robert W. Hahn, who is only identified as associated with the Reg-Markets Center. That group is also affiliated with AEI (it used to be a joint project with Brookings, but the mildly liberal wing of the consortium dropped out). The Center is largely funded by conservative think tanks and major corporations, including several major pharmaceutical firms.

Are any consumer groups writing and circulating briefs? If so, send me a link and I'll be glad to invite any academics who read this blog to get in touch about signing on.

Overutilization

"The United States spends substantially more per person on health care than any other country, and yet U.S. health outcomes are the same as or worse than those in other countries." So begins a commentary by Ezekiel J. Emanuel, a bioethicist at the National Institutes of Health, and Victor R. Fuchs, the well-regarded health care economist at Stanford University, which appears today in the Journal of the American Medical Association.

Welcome to the fray, gentlemen.

I don't need to go over the various statistics and health outcome anomalies covered in their essay, most of which have appeared at one time or another on this blog, in recent books like Shannon Brownlee's "Overtreated" and Nortin M. Hadler's "Worried Sick," or in the most recent reports of the Congressional Budget Office, which I reported on here and here. Bottom line: about 30 percent of health care expenditures are a waste, medically unnecessary, and, for all intents and purposes, a make-work program for physicians, drug companies, device companies, hospitals and everyone else on the health care 16-percent-of-GDP-and-rising gravy train.

So let's cut to the chase and go to their discussion about solutions. "Changing Americans' affinity for new technology is somewhere between difficult, impossible, and undesirable," they write shortly after agreeing that much of what is new isn't really better than the old.

How about changing physician training and practice so they are less dependent on commercial forces, less likely to generate high-priced specialists, and short-change primary care? Calls for changing physician education are "usually ignored," the soberly write. "Rapid reforms of medical education and training, even when widely acknowledged as essential, are uncommon."

Okay. How about curbing aggressive marketing to physicians by drug companies and other providers? "Such changes alone are unlikely to have a large effect on overutilization." Malpractice reform? "Reform would affect only some defensive practices."

So what is the most effective reform in their eyes? "More value-based co-payments, modeled on current tiered pharmaceutical benefits, that link the amount patients pay to effectiveness and cost of alternatives. . . this is not an all-or-nothing rationing scheme, but rather an ethical way to have patients experience costs but not at the expense of important outcomes."

Ah, I see. The market will save us through higher co-pays. I am dubious. When I go to the doctor, I rely on my learned intermediary to tell me what is necessary. Must I, Patient, now become I, Health Care Consumer, when I am sick and vulnerable? Must I conduct an internet search of the latest articles on PubMed and the U.S. Preventive Services Task Force database before determining if I should shell out an extra $30 for that test or drug? Or, should I simply reject these offered treatments because my insurance company decided they deserved a higher co-pay?

But more significantly, why am I, Patient, being asked to make these decisions at all? How many years of medical school do I have under my belt? Isn't that my doctor's job? Why don't they recommend the creation of a reimbursement scheme for the learned intermediaries who order up every diagnostic test, drug, and procedure which will encourage the doctors to use the most effective and cost-effective care? If we can have a three-tier co-pay scheme for patients, why not a three-tier reimbursement for doctors and hospitals? Market signals would work just as well for producers as for consumers, would they not?

Can't go there yet, say Emanuel and Fuchs. "Many more experiments are needed" before payers can implement pay-for-performance, bundled payments, partial capitation, value-based payment or "other payment methods to promote prudent use of resources."

Curiously, Emanuel and Fuchs make no mention of creating a comparative effectiveness agency to let patients and physicians alike know what works best. They simply presume that somebody -- the insurance companies that they admit waste $50 billion a year in excessive administrative costs, or the Center for Medicare and Medicaid Services, which is routinely defanged by Congress or special interests, who successfully lobby to get their new technologies paid for -- will be able to set appropriately tiered co-payments that will send consumers the market signals and hold down costs.

It is now a generally accepted fact that 30 percent of all health care expenditures are wasted. This statistic is hammered home year after year by the Dartmouth Atlas of Health, which compares outcomes in low-spending areas of the country to outcomes in high-spending areas and finds they are usually about the same. The implication of their work is that it is going to take a radical overhaul of the way medicine is practiced -- by physicians, by hospitals, by suppliers -- if the nation is ever going to put a brake on its ever-rising health care costs.

Emanuel and Fuchs understand the problem. Indeed, their essay this morning reflects what is rapidly becoming the conventional wisdom, which is summed up in their headline: "The Perfect Storm of Overutilization." Alas, like all too many diagnosticians of the rising health care costs crisis, they shy away from the radical prescriptions it will take to cure the disease.

What Took So Long?

The Food and Drug Administration on Monday slapped stronger warnings on anti-psychotic medications because they raise the risk of death in the nursing home-bound, slightly demented patients for whom they are often prescribed off label. In this fine blog post, my former colleague at the Chicago Tribune, Judy Graham, asks, "What took so long?"

Glaxo's Delay on Restless Legs Drug

GlaxoSmithKline is complaining that the Food and Drug Administration delayed in approving its once-a-day version of its Parkinson's disease drug, Requip (ropinirole). The drug, which mimics dopamine in the brain, has primarily been promoted as a treatment for restless legs, a disease invented by the company's marketing department.

According to this morning's Wall Street Journal, company executives told an investors conference that the FDA failed to give the drug priority status, which resulted in the drug coming to market after its patent on the thrice-daily version expired. The FDA is giving short shrift to drugs that are not innovative, the story suggested.

Let's explore this one a bit further. A once-a-day version of a drug that substitutes for a thrice-daily version isn't hard to make (it usually involves a minor modification of the original molecule that makes it harder to metabolize without detracting from its effectiveness). And, while it won't win anyone the Nobel Prize, a longer-lasting version does offer some benefit to patients in terms of convenience and increased compliance (patients are more likely to remember to take their pill every morning than every morning, noon and night).

So do companies rush to bring this level of "breakthrough" to market? No they don't. Whether it is for a phony disease like restless legs or a significant use like Parkinson's, they keep the long-lasting version in the wings until the patent expires on the original drug. In fact, they try to time their passage through the FDA so that it arrives in the marketplace just a few months before the old patent expires. This marketing-driven strategy seeks to wean physicians (and their patients) off the soon-to-expire patented drug by getting them to prescribe the newer version (using increased compliance as the selling point).

How long does it take to get regulatory approval for the newer version (including the necessarily clinical trials)? Hard to say, but obviously a lot shorter than the 10 to 12 years that it takes to get the original molecule approved. Five years is not an unreasonable estimate (only 12 to 18 months of which is after the completed application and data are submitted to the FDA for non-priority drugs).

A quick check with the Orange Book (the FDA's listings of medicines and their approval and patent expiration dates) shows that the original Requip was approved in 1997. Its key patents expired last year and in May of this year.

Glaxo knew the minute the drug came on the market that it could develop a version that only needed to be taken once a day. But did it rush into the lab to develop this innovation? Or did it slow its development program so that it could be marketed in time to replace the old drug when the patents expired? The evidence clearly suggests the latter.

So who is really to blame for the "delay" in getting Requip XL (the name given to once-a-day ropinirole) to market? Is it the FDA, or a corporate strategy that would sacrifice patient convenience and compliance in the name of bolstering the bottom line?

Evidence-Based Medicine in Russia

My last morning in Moscow, I had breakfast with a senior faculty member of the Russian Academy of Medical Sciences. Vasiliy Vlassov wants to bring evidence-based medicine to a land still enamored of the "salt cure" for lung diseases. Talk about an uphill struggle! The Scientific American website earlier today posted my story about our conversation.

NCCN to Reveal Oncologists' Financial Ties

The National Comprehensive Cancer Network late last week announced that beginning in July it would reveal the financial ties to drug companies of oncologists who write its clinical practice guidelines. The change came in response to a Center for Science in the Public Interest campaign to force NCCN to open the books.

“Historically, the NCCN has disclosed the names of companies with whom there are relationships,” said Dr. William McGivney, CEO of the NCCN said in a press release. “We now will apply that to individuals so that the public may better use the scientific, evaluative information that we provide.”

Last Friday, the Center for Medicare and Medicaid Services gave oncologists the okay to begin using the NCCN compendium, which is drawn from its guidelines, to justify payment for the off-label use of anti-cancer drugs.

While the change in NCCN's disclosure policy is a victory for transparency, it doesn't change the underlying reality that many of the drug uses listed in the compendium do not have much evidence to back their inclusion. Cancer clinical trials often show that drugs like Avastin slow the amount of time before tumors begin growing again, but just as often there is no significant reduction in the time to death. Yet these trials are routinely used to justify that particular use in the NCCN and other compendia.

For the war on cancer to progress, the public needs better information about the outcomes from the use of these drugs in very sick and dying patients. CMS should consider requiring physicians to electronically report the outcomes of their chemotherapy regimens, especially when they involve the off-label use of drugs.

Independent epidemiologists and biostatisticians (perhaps working at a comparative effectiveness agency?) would then have a powerful database for analyzing the outcomes from the use of these drugs. While such analyses will not have the same predictive power as controlled clinical trials, it would give researchers and practicing oncologists valuable insights into what really works and what doesn't when it comes to treating the more than 100 forms of the dread disease. Patients' health, and the nation's fiscal health, deserves nothing less.

Expert Warned FDA about Chantix

Yesterday ABCnews.com reported that John Spangler, director of Tobacco Intervention Programs at the Wake Forest University School of Medicine, warned the FDA and Pfizer a year ago of safety concerns with Chantix (varenicline). His warning foreshadowed last month's report from the Institute for Safe Medication Practices (ISMP) showing a high level of adverse events associated with the drug.

In a May 2007 letter to the editor responding to a Pfizer-funded safety study on use of Chantix over a 12-month period, Spangler raised questions about the high rate of adverse events in the Chantix-treated patients, 25 percent of whom dropped out of the study due to an adverse event, as compared with 10 percent of the placebo group. Moreover, 6 percent of the patients on Chantix experienced an adverse event that was considered serious. The investigators give little detail about these events, except to note that many were "cardiovascular conditions known to be comorbid with cigarette smoking." Only 2.4 percent of the patients who were on placebo experienced a serious adverse event.

"In this situation in particular, we're talking serious adverse events -- cardiovascular events," Spangler is quoted by ABCnews. "If you're putting someone on a drug that causes cardiac effects -- especially if they're already at higher risk of such effects -- you're doing them harm. You then have to do a risk-benefit study to see if the harm is greater than the benefit."

In his letter, Dr. Spangler notes the small number of participants (251 Chantix, 126 placebo) in the trial and states that "[u]ntil further safety data are available, these [safety] concerns should be made broadly public and require a long-term randomized controlled clinical trial adequately powered to determine actual safety."

As noted in the ISMP report, there were also some cardiovascular events during the preapproval trials of Chantix. The FDA safety reviewer noted that "[t]he serious adverse event data suggest that varenicline may possibly increase the risk of cardiac events, both ischemic and arrhythmic, particularly over longer treatment periods," although the reviewer, Howard Josefberg, M.D., noted that this finding was "far from definitive."

The experience with Chantix points out the need for the FDA to pay close attention to safety signals and, when appropriate, to require drug companies to conduct large clinical trials that can provide more definitive data on safety. In the meantime, smokers should be informed of the potential risks associated with Chantix.

-- PM

Health Wonk Review

The latest Health Wonk Review is up on the Health Affairs Blog. Check it out!

Life Expectancy Data Ignores Int'l Comparison

Life expectancy in the U.S. continued its slow but steady upward crawl, reaching an average of 78.1 years in 2006, according to this morning's Washington Post report on the latest data from the Census Bureau. The average woman in 2006 could expect to live to 80.7, the average men to 75.4. Infant mortality was down, the gap between men and women was down, and the gap between racial groups was down, suggesting the recently reported pockets of declining longevity in Appalachia due to rising obesity rates are precisely that, pockets. All good news.

Unfortunately, neither the government press release nor the mainstream reporter put this latest data in an international comparative context. How do we rank compared to other nations?

Not hard to find out, thanks to the Internet. According to the Organization of Economic Cooperation and Development, the U.S. ranked 24th out of 33 nations ranked by that organization. U.S. life expectancy of 77.8 in 2005 (it rose 0.3 years in 2006) trailed the OECD average by a full year and global leader Japan by a half decade.

At least we're not Russia, where life expectancy remains mired at about 65 years, trailing every other nation in the global survey. Others behind the U.S.? Turkey, Brazil, Hungary, China, Poland, the Slovak and Czech Republics, and Mexico. When it comes to the average person's health in the U.S., our descent into second world status is complete.

It would be nice if reporters pointed that out whenever the government offers rosy statistics on how well we're doing.

Health Care Still Sliding as Issue with Voters

The headline on the new Wall Street Journal/NBC News poll shows Sen. Barack Obama with a slight lead over Sen. John McCain. His troubles with white male voters continue to drag down what ought to be an overwhelming lead given the economic conditions in the country.

Most notable to me was the decision to devote just one paragraph in the story (its last) to issues. It read this way:

Concerns about the Iraq war and the economy dwarf all other issues, including terrorism, illegal immigration, the mortgage mess, the environment and global warming.

Where's health care? So I went to the actual poll data and found this ranking of the issues (respondents were asked to name which two issues they considered most important in this year's election):

The economy .................................. 47

Iraq................................................ 30

Energy ........................................... 28

Health care...................................... 23

Immigration ................................... 18

Family values issues ........................ 14

The environment............................... 9

Trade ............................................... 7

A year ago, health care was widely seen as the primary domestic concern of the American people. Now, the nation's faltering economy and soaring energy bills have pushed it off center stage.

Single-Payer in Taiwan

Congressional Quarterly carries a long article extolling Taiwan's single-payer health care system, which was only adopted in 1995 with the help of U.S. academics. Worth reading.

Adverse Events Reports Soar

The number of individuals who report negative side effects from taking prescription drugs has soared in the past decade, and now almost equals the number of adverse events turned in by physicians and pharmacists, according to newly released statistics from the Food and Drug Administration.

In 2003, the year before the Vioxx scandal broke, there were just under 50,000 such reports from consumers, about what it had been for the previous four years. But by 2007 that number had more than tripled to 174,206 adverse event reports. Over the same period, reports from providers rose 42 percent to 202,686 reports.

It is well-known that the FDA's adverse events monitoring system misses most unwanted and dangerous side effects because it relies on self-reporting by physicians and consumers/patients. That's why Congress last year voted more money to beef up the nation's post-market surveillance system. The FDA is currently hiring new biostatisticians to conduct epidemiological analyses of insurers' databases of patient outcomes like the one done by David Graham that proved just how dangerous Vioxx was.

But even when those new employees are in place, adverse events reporting by individuals, physicians and pharmacists will remain an important part of the system. Such reports alert regulators to the possibility that something may be wrong with a drug that was never noticed or was too rare to be picked up in the original clinical trials that led to the drug's approval. They are the clues that tell the biostatisticians where to look.

What these data clearly show is just how important consumer awareness is in generating those reports. The Vioxx headlines are fading. To help keep consumers vigilant, the FDA should move rapidly to put a prominent warning label on every drug container and package. It should state that the drug may cause unwanted and as yet unidentified side effects, and it should provide a 24-hour 800 number to call should such events occur. A similar warning should be contained on every direct-to-consumer print and broadcast ad.

Such labels cost manufacturers nothing. But they will generate additional anecdotal evidence that could help regulators identify the hidden dangers in some prescription drugs.

CMS Endorses Hiding Conflicts of Interest from Public

Last Friday, the Center for Medicare and Medicaid Services adopted a policy that makes a mockery of the concept of conflict of interest disclosure and will only serve to further obscure how the pharmaceutical industry is skewing the practice of medicine.

Last Friday, CMS announced it will begin allowing oncologists to refer to the National Comprehensive Cancer Network's guidelines and drug-use compendium when they seek reimbursement for the off-label use of anti-cancer drugs. The Center for Science in the Public Interest, in a belated public comment, had protested inclusion of the NCCN compendium because it does not disclose the individual conflicts of interest of physicians who write its guidelines.

To see the full CMS decision, you can go here. The relevant paragraph on the conflict of interest issue reads:

It incorporates a process for public identification and notification of potential conflicts of interest of the compendia's parent and sibling organizations, reviewers, and committee members, with an established procedure to manage recognized conflicts. The policy . . . (has) public disclosure the listing of all potential conflicts of interest and full disclosure of every organization that has provided funding to NCCN on their website. Member dues pay staff and operating costs, while industry grants pay distribution costs.

In fact, the compendium does not publicly disclose potential conflicts of interest as such disclosures are routinely made in the medical and scientific literature. Therefore, what CMS has posted on its website is a deliberate obfuscation.

As I pointed out here, the NCCN compendium does not list the conflicts of interest of individuals on its publicly available guidelines. It only lists all the companies that gave money or research grants to ANY of the physicians who served on the committee. The individual ties between specific companies and specific physicians are not revealed. This is the same strategy used by the American Society of Clinical Oncologists, which represents the nation's 20,000 oncologists, to hide conflicts of interest during its annual meeting, which just concluded in Chicago.

This policy turns disclosure on its head and renders it meaningless. It deliberately hides from the public, patients and practicing physicians the individual financial ties that oncology's thought leaders have to pharmaceutical firms. Congress should investigate whether it wants the decision to spend Medicare tax dollars driven by such a transparently non-transparent process.

Boosting Health Care in Siberia

It's amazing to realize one can fly three time zones east of Moscow and still be only half way across Russia. That's where I found myself this week on assignment for Scientific American. My destination was Tomsk Oblast, a state as large as Texas with only a million people. Tomsk is three-quarters swamp, chock full of oil and gas, and suffering from the Russian scourges of rampant alcoholism, unemployment and a tuberculosis epidemic.

While reporting the tuberculosis story, I discovered an interesting health care program put in place by the Putin administration. I couldn't help but think that it could be used by any country interested in delivering low-cost health care services to under-served communities. You can read about it in this story on the Scientific American website.

It's All About the Oil

Russia's Resurgence Rests on a Shaky Foundation

MOSCOW -- My second post from Russa is now up on the Scientific American website. I've been reading long-time Russia scholar Marshall Goldman's new book, Petrostate, on my travels here, and it provoked these thoughts as I wandered Moscow's streets during the long twilight hours.

Pfizer's Study Raises Issues with Chantix

Last Thursday I discussed the recent Institute for Safe Medication Practices report showing a high level of serious adverse events associated with Chantix (varenicline). Since then I became aware of a Pfizer-funded study comparing the safety and effectiveness of Chantix and nicotine replacement therapy in the form of a patch.

The study, published online in Thorax in early February, was a 52-week randomized trial in which participants received either Chantix for 12 weeks or a nicotine patch for 10 weeks. Participants (376 in the Chantix group and 370 on the patch) received counseling at every telephone and clinic visit. Persons with a history of depression or other psychological disorder and a host of medical conditions were excluded.

The self-reported "continuous abstinence rate" (CAR), confirmed by measuring exhaled carbon monoxide, for the last 4 weeks of treatment was 55.9 percent for Chantix (weeks 9-12) and 43.2 percent for NRT (weeks 8-11). CAR through week 52 was 26 percent for Chantix and 20 percent for NRT, with the difference just missing statistical significance. Since all participants in the trial received intensive counseling to help them stop smoking, these percentages are higher than what can expected in the real world.

Adverse events were experienced by 84.8 percent of the Chantix group and 70.3 percent of the NRT group with severe adverse events were experienced by 9.8 percent of the Chantix group and 7.3 percent of the NRT group. Two patients in the Chantix group experienced serious depression or suicidal ideation.

This study was too small and excluded too many categories of patients to give a full picture of Chantix's side effect profile. Some general observations seem warranted, however.

1. Patients in the Chantix group experienced significantly more side effects, including serious side effects.

2. At the end of 12 months, the advantage in effectiveness for Chantix was relatively minor.

-- PM

Blogging from Russia for Scientific American

Hello from Tomsk, Russia on the western edge of Siberia! On my way here on assignment for the Scientific American website, I stopped off in Moscow and visited with one of the non-government organizations (NGOs) that have popped up in this country in recent years to help the estimated one million Russians living with HIV. I wanted to get their perspective on the issue of major pharmaceutical companies increasingly moving their clinical trials to countries like this one.

My first blog post on my visit is available on the Scientific American website. I hope you check it out.