More on Rudy's Manhattan Institute Buddies

The New York Times covered the controversy in this morning's newspaper. The big laugh line is the Manhattan Institute's Gratzer accusing the Commonwealth Fund of having an ideological bias for trying to correct his ideologically-driven misuse of their statistics.

Bottom line: Great Britain's five-year cancer survival rate is 74 percent, not much below the U.S. survival rate of 82 percent. And, of course, the U.S. incidence rate is far higher because of all the PSA screening that we do, which leads to more people getting diagnosed and more people getting treatment of cancers that would never have harmed them. That artificially inflates the five-year survival rate and may account for most of the difference.

Rudy's Wingnut Cancer Stats

The Commonwealth Fund issued this press alert tonight. It's worth reading in its entirety since it reveals the lengths to which conservatives will go to trash single-payer health care systems; shows how cancer outcomes are not much different between the U.S. and Great Britain; and unmasks the miserable state of prostate care in the U.S. (FYI: The City Journal is a publication of the libertarian Manhattan Institute):

The Summer 2007 issue of City Journal included an article authored by David Gratzer, M.D., that says the U.S. prostate cancer survival rate is 81.2 percent and the U.K. survival rate is 44.3 percent. According to abcnews.com, Gratzer has cited a seven-year-old Commonwealth Fund report as his source for the statistics. In fact, the five-year survival data cited in the City Journal article do not come from The Commonwealth Fund report, and cannot be calculated from that report. What the report, Multinational Comparisons of Health Systems Data, 2000 by Gerard F. Anderson and Peter S. Hussey of Johns Hopkins University, includes are data on prostate cancer incidence and mortality rates in the two countries.

Specifically, The Commonwealth Fund report features a chart showing that, in 1997, the incidence of prostate cancer in the U.S. was 136 per 100,000 males and the mortality rate (death rate) was 26 per 100,000 males. By comparison, in the U.K. the prostate cancer incidence was 49 per 100,000 and the death rate was 28 deaths per 100,000. (The prostate cancer incidence rate--which is the number of men diagnosed with the disease in a given year--in the U.S. is thought to be higher because prostate cancer screening is much more common in this country.) Five-year survival rates cannot be calculated from incidence and mortality rates, as any good epidemiologist knows.

The incorrect survival statistics in the City Journal article have since been used in speeches and a radio ad by former New York City Mayor Rudy Giuliani. The Commonwealth Fund believes it is important that all presidential candidates have accurate and reliable information.

Abbott Sued Again, This Time by Rx Chains

My eye is always attracted to stories about Abbott Labs and its anti-AIDS drug Norvir, whose development I documented in my book. The company's development program for AIDS drugs began life with a government grant, and to this day, the government retains "certain rights," never exercised, to the Norvir patent.

Yesterday, the Wall Street Journal reports, four drug store chains and a wholesaler sued Abbott for arbitrarily inflating the price of Norvir fourfold as part of its strategy to monopolize the protease inhibitor market (protease inhibitors are one of the three drugs used in many antiretroviral therapy combinations). AIDS activists and the Service Employees International Union had previously sued the company on the same grounds.

If we had a government (and a Justice Department) that cared about consumer protection, it would join in these suits by invoking the government's right to ensure that the drug is made available on reasonable terms.

Cuomo Settles with Insurers

The Journal also reports this morning that New York Attorney General Andrew Cuomo has reached an agreement with the big health insurers over doctor rankings. The settlement demands that ranking systems be transparent and based on true quality standards, not costs. The story also says that the settlement will set up a national system for establishing quality ratings, which could be used by people who are doctor shopping. The investigation began in August.

Loophole in New FDA Law: Reporting Failed Trials

Barry Meier of the New York Times has an eye-opening article this morning pointing out a major flaw in the recently passed Food and Drug Administration reform law. Clinical trials that are halted because their products will not meet the FDA's safety and efficacy standards probably won't have their results registered in the government's clinical trials database because the results are never compiled. The story cites a failed silicone breast implant trial by Inamed as one example. The trial's existence and protocols presumably were registered at ClinicalTrials.gov because the company usually wants a successful trial published in a medical journal, and most of the good ones conform to the International Committee of Medical Journal Editors guidelines that require registration of clinical trials before the first patient gets enrolled if the results are to be published.

But negative results? That's the blackhole in every field of science. And, as today's story points out, this black hole in the medical information system has very real and negative consequences for public health.

Open Access Bill Advances despite Publisher Protests

Free public access to all published articles produced from National Institutes of Health-funded research moved one step closer to reality last week. The bill, pushed by a coalition of more than 200 academic libraries, the U.S. Chamber of Commerce, and many academic societies, was included in the Labor-Health and Human Services appropriations bill that overwhelmingly passed the Senate. The House has already passed a similar measure. President Bush has threatened to veto the bill for other reasons.

Heather Joseph, executive director of the Scholarly Publishing and Academic Resources Coalition of the Association of Research Libraries, hailed the Senate vote, which would vastly expand the content in NIH’s free library at PubMedCentral. "This policy sets the stage for researchers, patients, and the general public to benefit in new and important ways from our collective investment in critical biomedical research," she said. The provision was opposed by the Association of American Publishers, which includes leading scientific publishers like Elsevier, Wiley, and the American Chemical Society, which claim their ability to support independent peer review of new studies depends on exclusive copyrights.

The publishers' campaign triggered an anonymous email campaign by an ACS insider that accused the chemical society's leaders of opposing the provision because their high salaries and bonuses are tied to publishing profits, The Scientist reported. Several top officials at ACS, which generates about a half a billion dollars a year in revenues from its 36 journals, earn over $750,000 a year, according to its latest Internal Revenue Service filings. The anonymous emailer's allegations drew an angry open letter from ACS chairwoman Judith L. Benham, who wrote that "the ACS's position on open access has been developed carefully over many years, in consultation with scientists and publishing experts from a wide range of scientific disciplines and interests."

ACS belongs to the Association of American Publishers, which earlier this year hired Dezenhall Resources, best known for defending Enron executives and opposing public interest groups, to launch a campaign opposing the open access legislation. In August, AAP launched a new website called Prism (Partnership for Research Integrity in Science and Medicine) that echoed the claim that open access would undermine peer review. That sparked James D. Jordan, president of Columbia University Press, to resign from AAP. Stephen Bourne, chief executive officer of Cambridge University Press told The Chronicle of Higher Education that "Prism's message is oversimplistic and ill-judged, with the unwelcome consequence of creating tension between the publishing community and the proponents of open access."

The preceding appeared first in Integrity in Science Watch, a publication of the Center for Science in the Public Interest.

Correction

An addendum to my story on Ruth Nussenzweig: Her husband Victor is alive and well and was sitting with her at Friday's session at Sanaria. I've corrected the story, and my apologies!

The Dr. Ruth of Malaria Research

She’s the Dr. Ruth of malaria research. She’s short, has meticulously coifed gray hair, and speaks with a thick accent. But she’s no parvenu of mosquito mating habits.

Ruth Nussenzweig, trained in Brazil, long at New York University, published her first paper on the microbiology of parasites in 1954. She and her husband Victor outlined the path to an X-ray attenuated antimalaria vaccine in Nature in 1967. In the 1970s, she helped discover the parasite’s cloaking protein, which GlaxoSmithKline is using to make a malaria vaccine now in clinical trials.

And as she stepped away from the podium Friday at the launch of the Sanaria, Inc. manufacturing facility in Rockville, Md., the 20 staffers who will make an X-ray attenuated vaccine that could go into human clinical trials as soon as next year, along with the 200 public health officials, scientists and dignitaries who’d come to cheer them on, gave her a standing ovation, not so much for anything she’s done lately, but for having carried the torch through the long, dark night when there was no money in the field of malaria vaccine research.

That’s no longer the case, thanks to the generosity of the Bill and Melinda Gates Foundation. John McNeil, director of research at the Foundation-supported PATH Malaria Vaccine Initiative, told the crowd that not only are there two vaccines in or heading for clinical trials, but his group is funding researchers who have at least three more promising candidates in their labs.

Financial largesse can be a mixed blessing, of course, and the malariologists of the world can be excused if they are feeling a bit of pressure. At a forum held earlier this month in Seattle, the computer mogul-turned-philanthropist told his grant recipients that malaria’s eradication – a goal not articulated in global health circles since the 1970s – was back on the agenda. “I’m optimistic that we can make this disease history,” he said.

A vaccine isn’t needed to make major inroads against the disease, which strikes an estimated half billion people a year and kills one to two million, mostly children in sub-Saharan Africa. Mass distribution of insecticide-treated bednets, selective use of indoor spraying, and widespread deployment of artemisinin-combination therapy – the most effective new drug to come along in half a century – could go a long way towards eliminating the disease in countries where public health systems are effective at deploying these strategies.

But eradicate the disease where grinding poverty, corrupt governments and endless civil strife are endemic? That’s where the PATH-MVI research program, based on the pioneering work of Ruth Nussenzweig, is seen as crucial. “How do we contain disease in low-infrastructure settings,” asked Kent Campbell, a senior epidemiologist with the group. “Vaccines.”

Leave it to the one African on the podium to warn about the limits of technology in conquering this age-old scourge. “How many infectious diseases have we eradicated,” asked Adel Mahmoud, an Egyptian-born infectious disease researcher who served as president of Merck’s vaccine unit from 1999 to 2005 and is now a professor at Princeton University. The answer to his rhetorical question is one – smallpox – and researchers have repeatedly shown that only its limited scale in the general population made it an ideal target for isolation and elimination. “We have been warned not to use that as a model,” he said.

Given the technical difficulties of producing a successful vaccine of any type, the odds against developing a vaccine that provides immunity against a complex and adaptable organism that is old as mankind itself are huge. And even if the researchers succeed, the roadblocks to getting it massively deployed are enormous.

But the richest man in the world has thrown down the gauntlet, and backed it with his money. Eradication of malaria is back on the global public health agenda after a two-generation absence. Ruth Nussenzweig, her head barely able to reach the microphone, said only that she was “happy to be able to play a small part.”

Gerberding and Her Censors

The Associated Press yesterday reported that the administration's censors inside the Office of Management and Budget changed testimony given by Julie Gerberding, the head of the Centers for Disease Control in Atlanta, on the impact of global warming on health. Today's New York Times and Washington Post report that she's okay with that.

"I said everything I needed to say," she said.

Democrats in Congress and public interest groups like Physicians for Social Responsibility are attacking the White House for its political interference with science. But that charge is growing stale. We know where the Bush administration stands on the role of science in policymaking. It's opposed to using it if it stands in the way of the special interests it chooses to represent.

The more interesting question in this flap is where does Julie Gerberding stand? Doesn't there come a point where public officials, especially those charged with protecting public health, have a larger responsibility than protecting their own careers? The issue is not whether the nuances of how global warming may impact public health were sufficiently aired in a single hearing on Capitol Hill.

The more important long-term issue worth raising, especially as we contemplate the post-Bush years, is what rules should govern the relationship between high government officials and the politicians at whose pleasure they serve. Of course presidents get to appoint their cabinet members and hundreds of other high-ranking officials across the government. But once they get in those positions, their first loyalty should be to what is in the best interests of the American people. When a White House -- any White House -- steps in to manipulate the performance of that job for political reasons, you're on the slippery slope to the next Katrina and "you're doing a heckuva job, Brownie."

The political police had no business editing the remarks of the nation's highest-ranking public health official. Even before it became publicly known, she should have resigned her post in protest. This incident tells us more about Julie Gerberding than it does about the Bush administration, whose views on science and global warming are well known.

IOM To Take On Conflicts of Interest

Conflicts of interest in medicine are ubiquitous, the editor of the Journal of the American Medical Association famously wrote a few years ago. The medical profession has two choices for dealing with this fact. It can either accept it and search for ways to manage conflicts of interest so it doesn't harm patients, influence research or debase medical education. Or it can seek to reduce its influence.

The prestigious Institute of Medicine, an arm of the National Academy of Sciences, has opted for a management strategy. Next month, one of its study committees will kick off an effort to develop model guidelines for managing conflicts of interest in medicine. The charge to the committee states that the guidelines should not stand in the way of academic collaboration with industry. They also state that the guidelines should reflect a consensus of the panel.

The tentative appointments to the 15-member panel include three members granted conflict-of-interest waivers because of their ongoing ties to drug and medical device companies, and at least one other with recent ties to industry that were neither waived nor revealed on the IOM website. One of the panelists is a recently retired scientist from Pfizer.

Prominent researchers in the field who were not appointed to the panel by the IOM included Jerome Kassirer, former editor of the New England Journal of Medicine and author of "On the Take," Sheldon Krimsky of Tufts University, Lisa Bero of the University of California at San Francisco, or Eric Campbell of Massachusetts General Hospital, who just last week published a study documenting that 60 percent of academic department leaders at med schools have ties to industry.

Four scientists with ties to industry including a former industry employee are on the panel. All the prominent critics and informed researchers are excluded. The charge is to reach a consensus that doesn't jeopardize industry-academic collaboration. Sound fair and balanced to you?

If you're interested in commenting on the makeup of this panel, you can visit the IOM website and file comments here.

The $800 Million Pill Revisited

Sociologist Donald Light of Princeton University has just published a major critique of a year-old Congressional Budget Office study that endorsed the drug industry argument that it costs nearly a billion dollars to develop a new drug.

The review, which can be found on this website, analyzes drug company tax returns to show that R&D costs are well below the common $1 billion claim. Arguing that the drug industry-funded study by the Tufts Center for Drug Development, which CBO relies on, uses a biased sample comprised of only the most costly drugs, Light suggests the median cost for new drug development is closer to $300 million.

Why? Half of the larger sum is estimated profits that would have been made had the research not been done. But since R&D is an expense fully deducted every year, a third of those profits would have been eaten up by the tax man. “Companies cannot have it both ways,” Light writes. “They can’t say that research is a long-term investment to justify high prices and then treat them as just another business expense.”

So now we have a sociologist and a journalist (me) pointing this out. When will the business school and accounting professors chime in? When I wrote my book, every business school prof I spoke with admitted that the Tufts number, which is repeated ad nauseum in the health care economics literature and the press, was bogus.

Light also challenges the widely cited industry claim that lower profits will result in less research. “No other research-based industry makes this argument. When they find their profits declining, they redouble their R&D efforts.”

As I put it in my book: until I covered the drug industry, every CEO I ever interviewed or listened to insisted that his company was preparing for the future by investing heavily in R&D. If it didn't, the company would wither and die. Only the drug industry says if it doesn't get high prices, it will refuse to invest in R&D.

The drug industry argument is the intellectual equivalent of the little boy who says: "If I don't get my way, I'll hold my breath until I die." Oh grow up already.

To be fair, the industry isn't relying on this argument as much as it used to. It now justifies high prices as "value" pricing, claiming that $3 a pill for an aspirin-equivalent is justified by its medical value. Light takes on this argument, too, in his paper by pointing out that most new drugs are no better than what's already on the market.

There's not much new in Light's critique. But it's nice to see the academic literature being seeded with alternatives to the drug industry-funded conventional wisdom.

CMS Counsel Almost Upset Eye Trial

The Wall Street Journal's Health Care blog over the weekend carried a letter from Sen. Herb Kohl (D-WI) to the Center for Medicare and Medicaid Services. The chair of the Senate Committee on Aging wants to know how much the agency spends on Lucentis and Avastin, both of which can be used for treating advanced macular degeneration (AMD) in seniors. The former cost $2,000 a shot. The latter cost $40 a shot. Kohl also wants to know what steps CMS is taking to lower its costs.

The agency, which is the primary insurer for the aged, has a big stake in showing the cheaper drug works just as well (it should, it's basically the same thing). What Kohl will be told is that CMS is helping to finance a comparative effectiveness trial testing whether the cheaper treatment works just as well. You can get lots of background on CMS' role in financing the trial of these two drugs in GoozNews posts here, here, here, here, here, and here.

Bottom line is that CMS last July agreed to pay for the more expensive drug as part of its new clinical trials payment policy, which says it will pay for "routine" care for seniors who participate in clinical trials. Genentech, which manufacturers both drugs, had refused to supply the drug to the trial's organizers, who are being funded in part by the National Eye Institute. Daniel Martin of Emory University in Atlanta is the principal investigator.

However, not everyone inside CMS was pleased. Martin made a presentation at an NIH conference a few months ago (it was on the web for a while, but I can't find it now) that revealed a glitch in the effort. The office of the general counsel at CMS intervened in a way that made it more difficult to get the trial up and running. The administration lawyers interpreted the new policy to mean Medicare was not allowed to provide ADVANCED payment for the drugs.

That meant the patients in the expensive Lucentis arm of the trial will not be blinded (an unfortunate double entendre) as to what treatment they are getting because they would be paying the usual co-pay for Lucentis, which could amount to hundreds of dollars per treatment. Seniors in the Avastin arm would only be paying $5 or $10 for their Avastin co-payment.

After reading this on the web, I emailed Martin to see if this was going to postpone the trial or make its results less relevant. Here's what he wrote back:

The Revised Medicare Clinical Trial Policy that became effective July 9 contains explicit language that allows Medicare to pay for Lucentis in this trial. That was the only thing that we absolutely needed. The demonstration project that I referred to (advanced payment) would have allowed for full masking of the drug. However, that is not essential and in fact really not necessary at all for the most important study questions. We were willing to work on that while we were waiting for the July 9 Policy change. But now that we are past that date, we are no longer willing to wait. We will have masked visual acuity assessment and masking of the treating physician at the local level. It will work well. It is a shame that our demonstration project was not approved by HHS. . . We hope to complete enrollment by the end of 2008. We hope to report first year results in the first half of 2010.

So the Bush administration succeeded in delaying the trial's start-up, but was unable to to deep-six it altogether.

Apocolypse Now?

President Bush last week says he wants to prevent Iran from "having the knowledge necessary to make a nuclear weapon."

Over the weekend, Our Kurdish allies in the northern part of Iraq harbor a terrorist group that stages a cross-border raid that kills 17 soldiers of our NATO ally, Turkey.

In Baghdad's Sadr City, U.S. warplanes bomb an Shiite neighborhood as soldiers kill 49 "fighters" as military planners bunkered in the Green Zone hatch a full-scale offensive against Shiite militias.

Meanwhile, the Taliban/al Qaeda -- the real terrorist threat in the Middle East -- shows its muscle by killing 130 on the streets of Karachi as Benazir Bhutto, a close ally of the U.S., returns from political exile.

This is American foreign policy in action: ignoring the real threat in the hilly hinterland of Afghanistan/Pakistan while launching a hot war of Us against All in Iraq. In today's Washington Post, Newsweek columnist Fareed Zakaria -- a centrist if ever there was one -- says "the American discussion about Iran has lost all connection to reality" before launching into a discussion of the wisdom being offered by Norman Podhoretz, who has declared that Iranian president Mahmoud Ahmadinejad is "like Hitler" and is seeking to impose a "new order dominated by Iran and ruled by the religio-political culture of Islamo-fascism" on the Middle East.

And what order is the Bush administration, whose ear Podhoretz has, trying to impose? A democracy that sends warplanes against schools and neighborhoods, Kurdish terrorists against allies, and our own soldiers into an endless quagmire against Shiite militias?

It seems to me that we're on the brink of a much wider war in Iraq. Is there no one in Congress that can rein in this out-of-control presidency?

Big Pharma P.R. Man Bashes Comparative Effectiveness

The New York Times op-ed page rarely carries columns by paid, professional advocates of a progressive stripe. Many of its regular columnists are liberal, of course, and left-of-center academics, think tankers and authors often grace its pages with their opinions. But when was the last time you saw an argument advanced in the Times by someone from the Sierra Club, Public Citzen or the labor movement? My quick check of the Times archives suggests it was 2004 in a joint op-ed by Carl Pope of the Sierra Club and Ron Gettelfinger of the UAW.

If you're a paid advocate, your opinions almost never make the editors cut. And frankly, even though I am someone who in my current incarnation is penalized by that bias, I know why it exists and respect it. The journalistic ideal posits that an opinion writer tackle a subject with an open mind, marshall the facts, and arrive at a conclusion through the prism of his or her own intellect and experience. In that charmed circle, where I lived for many years, paid advocates are simply suspect.

That's why I was rather surprised yesterday to read an op-ed attacking government-underwritten comparative effective research that was written by a professional public relations executive. His clients include some of the world's largest pharmaceutical houses, which have a direct stake in opposing such a research center. Not only that, the paper did not reveal the primary source of the writer's income, but rather allowed him to hide behind an "astroturf" (fake grass roots) non-profit called the Center for Medicine in the Public Interest, which (at least he admitted this much) takes money from the drug industry.

The author, by the way, was Peter Pitts. He is a vice president at Manning Selvage & Lee. And you can read a list of the firms' clients here.

I suspect it's been a long time since a professional p.r. man was able to slip an undisclosed op-ed into the Times. I congratulate Mr. Pitts on his coup. Edward L. Bernays would have been proud.

I suppose my job now is to refute Mr. Pitts' argument. Frankly, I thought it was better put by Scott Gottlieb of the American Enterprise Institute in the Wall Street Journal in late August, where, I should add, his relationship to the pharmaceutical industry was straightforwardly described.

So, instead of doing a line-by-line refutation of the tired argument that knowing how well various medical therapies work in comparison to each other will somehow choke off pharmaceutical innovation, I will simply reprint what I wrote to the editors of the Journal, which printed my letter.

I was surprised by the anti-capitalist undercurrent of Scott Gottlieb's attack on comparative effectiveness clinical trials ("The War on (Expensive) Drugs," Aug. 30). When I took Economics 101, it was axiomatic that efficient markets required consumers to pursue their own economic interests - like choosing less expensive drugs if they provide the same or better therapeutic benefits as more expensive options.

"Unfortunately, today's pharmaceutical marketplace operates inefficiently because it doesn't provide consumers or prescribing physicians the information needed for medically or economically rational decisionmaking. The comparative effective trials authorized in the children's health insurance bill would help eliminate this information gap. . . "

I will not be writing a similar letter to the Times. Instead, I will spend the next few weeks scanning its corrections column to see if the editors offer a proper identification for Peter Pitts.

For more on this issue, visit yesterday's post on Health Care Renewal by Dr. Roy Poses of Brown University. He has links there to some of his posts where he lays out the counter-arguments quite well.

Others who want a the mainstream discussion about why we need and how we should organize a solid U.S. version of a comparative effectiveness institute can read this article by Gail Wilensky in Health Affairs and this article by the National Institute of Health's Ezekiel Emanuel and colleagues in the Journal of the American Medical Association (sadly, subscription required to read both). While I have some minor quibbles about organizational issues addressed in both articles, it's worth looking at them because it shows the bipartisan recognition of the need for comparative effectiveness research. Wilensky ran the Center for Medicare and Medicaid Services (then known as the Health Care Finance Administration) in the Bush I administration, while Emanuel is Democratic Party heavyweight Rahm Emanuel's brother. And whlie I shouldn't make presumptions about his party affiliation based on his brother, I've had lunch with EE and can confirm based on that conversation and following his articles over the years that those two apples didn't land very far apart after falling from the same tree.

Malaria Vaccine Advances

There is good news for children in the developing world this morning as The Lancet reports on an early safety trial for a malaria vaccine. An estimated one to two million children die a year from malaria because their relatively weak immune systems cannot fight off the high fevers caused by the mosquito-borne parasite.

The trial was limited -- just 214 kids. It was designed to test safety, and passed. But the study also showed a moderate reduction in malaria infections among the innoculated group.

The company manufacturing the vaccine -- GlaxoSmithKline -- is planning a third stage clinical trial to show efficacy. The New York Times report says the company plans to spend up to $600 million in developing the vaccine, just $100 million of which is coming from the Bill and Melinda Gates Foundation. The company told the Times that should the third stage trial prove successful, it will make the vaccine available at a price that health agencies in the developing world can afford.

So how will the company earn back its investment? Glaxo isn't a charitable organization after all. One little-noticed provision in the recently passed Food and Drug Administration reform bill offers one form of reimbursement. Inserted by Sen. Sam Brownback (R-KA), it states that companies that develop a breakthrough drug or vaccine for a disease that affects mostly poor countries will get a voucher for one expedited review at the FDA of any other drug of its choosing. These are known as "priority" reviews.

So if a company has a me-too drug for, say, cholesterol reduction that has the potential of garnering $3 billion a year in sales, the review at the FDA will have to be completed within six months instead of the regular 12 or 18 months that it takes the agency to complete a "standard" review. That will give the company anywhere from six to 12 months of additional marketing exclusivity for this drug while it is still on patent. That translates into an additional $1.5 to $3 billion in sales.

No one objected to this provision as it sailed through Congress along with the rest of the FDA legislation. It's like the controversy surrounding spraying huts with DDT. Who wants to be sticking their finger in the air and whispering, "hey, isn't there a better way to do this" when you know all you'll get for your efforts is the right wing noise machine (yes, that machine is active on global health issues, too) accusing you of standing in the way of poor kids getting vaccinated or protected from malaria.

So, in the spirit of strapping a bullseye on my back this morning, allow me to stick my finger in the air and whisper, "there is a better way to do this." It's called the prize system.

The economic logic of the Brownback incentive scheme is to get patients in the developed world to pay for breakthroughs for diseases of the developing world. It does this by creating a perverse, new incentive for drug companies to continue developing me-too drugs. Doesn't it make more sense to create an incentive that only encourages the good and not the not-so-worthy? Moreover, doesn't it make sense to have everyone pay for this breakthrough on malaria, not just people who suffer from whatever condition the me-too drug is aimed at?

A prize system would eliminate the perverse incentive while preserving the good one. How would it work? All pharmaceutical industry sales all across the globe could be taxed one percent (this would raise about $5 billion a year on the roughly $500 billion in sales) to go into an innovation prize fund that would be awarded to companies that develop significant new drugs and vaccines, whether they are for the developed world or the developing world. Then the technology could be turned over to generic manufacturers, who could provide it at cost to the world's health care systems, whether publicly or privately operated.

I'm told Sen. Bernie Sanders (I-VT) is preparing legislation creating such a prize system. I've written about this concept before in the context of stem cell research.

There's no quarreling with the assertion that this Glaxo effort to develop a much-needed malaria vaccine -- an effort, by the way, that has bedeviled scientists for decades because of the complexity of the parasite -- ought to receive a multi-billion-dollar reward if it succeeds. However, the best way for paying that reward ought to be an open question.

Dr. Congress Makes a House Call

As I mentioned yesterday, the Food and Drug Administration wrote a strong letter to Capitol Hill last week backing the Center for Medicare and Medicaid Services' restrictions on the use of erythropoietin-stimulating drugs like Aranesp and Procrit during cancer chemotherapy. The FDA black box warning, the letter pointed out, called on oncologists to use the lowest possible dose for avoiding blood transfusions since higher doses of the drugs to boost energy -- which, of course, results in higher sales for their makers, Amgen and J&J -- leads to more deaths and faster tumor growth in cancer patients.

Despite this evidence, Congress is considering a resolution to overturn the CMS payment decision, which went into effect late last month. It has at least 26 co-sponsors already and the drug companies' lobbyists are out in force trying to get it passed. So is the American Society of Clinical Oncologists, whose members profit from greater sales of the drugs.

Yesterday, a coalition of consumer groups including the Center for Medical Consumers, the Center for Science in the Public Interest, Consumers Union,
National Research Center for Women & Families, National Women’s Health Network, the TMJ Association and U.S. PIRG wrote every member of Congress asking them to vote no on H.J. Res. 54, which would overturn the CMS decision. I thought it worth reprinting here because of the principles at stake, which are outlined in the letter:

October 16, 2007

Dear Member:

We urge Congress not to interfere in the efforts of the Centers for Medicare & Medicaid Services and the Food and Drug Administration to use the best available science to determine the proper dosing of erythropoietin stimulating agents (ESAs). The safe and proper dosage of this drug in very vulnerable cancer patients is an extremely technical issue. Congress should leave these life-and-death medical decisions to the professional, objective physician-scientists at our nation’s health agencies.

H.J. Res. 54 or similar proposals in the Senate are a direct violation of this principle. The FDA has issued a “black box” label warning against excessive use of ESAs. There is significant evidence that the overuse of ESAs can actually speed tumor growth and early death in cancer patients. After more than a year of study, CMS issued a national coverage decision (NCD) in July that took this latest evidence into account. Congress should not substitute its own judgment for that of CMS and the FDA on these issues.

While it is true that the American Society of Clinical Oncologists, which represents the nation’s cancer physicians, protested the CMS decision, we cannot help but note that companies and physicians make enormous windfall profits from the sale and use of ESAs. Now they are trying to convince Congress that Medicare is denying a needed medical service.

This is not the proper venue for their objections. In late September, CMS invited ASCO to submit evidence to support the agency reopening its coverage decision. It is altogether fitting and proper that physicians in community practice and physicians at CMS who determine payment policy adjudicate their differences in this manner, rather than through Congressional intervention.

We also must note that some provider groups opposed previous reductions in the windfall profits that came from the reimbursement system of various cancer drugs. They said it would radically reduce treatment options and hurt patients. Those statements have been proven untrue. Self-serving arguments about the negative consequences of a proposed payment policy is no substitute for objective, scientific evidence.

Congress should set broad policy objectives and standards for Medicare, but Congressional interference regarding coverage policies for specific medical products would set a terrible precedent. It would encourage companies making medical products as well as medical specialty organizations to constantly ask Members of Congress to override scientific evidence and spend taxpayer dollars needlessly on products whose sale would benefit those companies or specialties more than they benefit patients. In some cases, such overrides could promote the use of medical products in ways that are potentially dangerous to patients because they are unsafe or ineffective.

Health care costs are the leading domestic consumer issue. Congressional interference on individual reimbursement decisions at CMS will just feed those health inflation fires while possibly causing harm to patients.

Please reject H.J. Res. 54.

Sincerely,

FDA Backs CMS on ESAs

A lot of initials, I know, but Rep. Pete Stark (D-CA) and Henry Waxman (D-CA) just released a letter from the Food and Drug Administration that firmly endorses the Center for Medicare and Medicaid Services' restrictions on the use of Aranesp (Amgen) and Procrit (J&J) in cancer chemotherapy patients. The two companies have financed a massive lobbying blitz to role back CMS' July coverage decision, which limited use of the drugs because they have been shown to spur tumor growth and increase mortality.

The lobbying blitz is paying off on Capitol Hill. A House joint resolution sponsored by Rep. Anna Eshoo (D-CA), whose district includes Amgen's headquarters, that would rescind the July decision has garnered at least 26 co-sponsors. It has also won backing from the American Society of Clinical Oncologists, which had claimed that the FDA label and CMS policy were at odds.

Who put Congress in charge of medical decision making? If ASCO has a complaint about CMS payment policy, it should provide evidence to the physicians at that agency who made the decision (which, we have confirmed today, is in line with the FDA label).

O'Neill's Bad Bargain

Former Treasury Secretary Paul O'Neill is a decent man. As documented in Ron Suskind's book, "The Price of Loyalty," his intellectual honesty forced him to quit the Bush administration two years into its first term over its economic mendacity. It was a harbinger of the national security mendacity to come.

He's back this morning with an op-ed in the New York Times outlining his grand bargain on health care. In brief, it's the Republican plan. Everyone should have to buy catastrophic health insurance, with individuals on their own for basic care. Help on that basic care should only go to the poor. His one nod in a liberal direction is his preference for a national pool for the catastrophic plans.

This is a prescription for reducing the U.S.'s already inadequate levels of preventive care. Forcing people to absorb first dollar coverage will do nothing to encourage people on the road to chronic disease (smokers and the obese, for instance) to change their behavior. It would do nothing to screen the population to find the 20 million Americans with untreated hypertension so they could be given generic drugs and counseling. Ditto for people with high blood sugar on the road to diabetes. And the nation's cancer screening rates will remain low.

The catastrophic insurance model assumes the major health care fear facing most Americans is the threat of unreimbursed hospitalization for accidents or major, unforeseen illnesses. Wrong. About three-quarters of all health care spending goes for the treatment of chronic disease. Wherever one puts the cut-off point for the catastrophic plans, it assures that millions of people with heart disease, diabetes, Parkinson's, and a host of degenerative disorders will be spending that level each and every year before their "insurance" kicks in. Chronic disease is not a one-off event.

Unfortunately, there is a superficial appeal to plans like the one outlined by O'Neill. If you are healthy, wealthy and unconcerned about the overall state of America's health, it could save you a lot of money.

Pfizer and Sermo

Pfizer announced today that it signed a major deal with Sermo.com, the online physicians networking site that allows docs to share experiences. To one expert (ah-hem, me), this is a "coup for Pfizer," who just discovered another way to deliver to its sales rap to physicians. To hear more, listen to this Marketplace report.

Workplace Cancers Underreported

"The Secret History of the War on Cancer" by Devra Davis, just published by Basic Books, isn't getting the attention it should. Perhaps a new study by UK researchers reported by the BBC will help focus needed attention on one of its central claims: that the environment is a major contributor to cancer causation and any effective strategy for reducing incidence of the disease must focus attention on the workplace and community toxics that can lay hidden time bombs in peoples' bodies.

The new study claims that the British government’s 26-year-old figures on occupational cancer grossly underestimate both the numbers of workers exposed to cancer risks and the number who develop work-related cancers.
The existing figure, which estimates 6,000 work-related cancer deaths annually in the UK, are based on an influential 1981 study by Richard Doll and Richard Peto, commissioned by the now defunct U.S. Office of Technology Assessment.

That study, later published in the Journal of the National Cancer Institute, has been cited in over 441 scientific articles to debunk claims that environmental causes are significant contributors to cancer. Critiques of the Doll and Peto study point to the authors’ sole reliance on epidemiologic studies of workers in large industries and their failure to consider exposures in smaller workplaces, as well as the limitation of their analysis to deaths in those under age 65.

Last year a group of European researchers revealed that Doll had financial relationships with a number of industries that manufacture cancer-causing chemicals, including Monsanto, the Chemical Manufacturer’s Association, and Dow Chemical.

The new study, led by Andrew Watterson of Stirling University in Scotland, estimates that UK work-related cancer deaths are between 12,000 and 24,000 every year. Watterson and one co-author, it should be pointed out, have consulted with law firms representing workers involved in occupational cancer lawsuits.

Inequality and the Coming Downturn

Economic events this week merit my switching gears this morning and putting my economics reporter hat back on . . .

Retail sales are falling, but the stock market remains ebullient. A weakening dollar reduces the trade deficit, while the projected federal budget deficit shrinks to less than $100 billion. Unemployment is at a six-year low, but income inequality is approaching levels not seen since the eve of the Great Depression.

Indeed, while income has increased smartly for the top 1 percent of the population, the bottom 50 percent has actually seen its real income decline slightly in this decade, according to the latest figures from the Internal Revenue Service reported in both today's New York Times and Wall Street Journal. The Times analysis suggests that 95 percent of folks saw their incomes decline between 2000 and 2005, but only the Bush administration's paltry tax breaks for those in the middle brackets (most of its benefits went to the very rich) kept far more people from losing ground.

Every one of these signs points to a business cycle peak. Stocks are always highest, unemployment lowest and budget deficits smallest just before the fall. Maldistribution of income and higher import prices fed by the weak dollars helps explain declining retail sales (the concommitant uptick in exports for the shrunken manufacturing sector no longer offsets the decline, if it ever did). The mortgage crisis is also eroding demand.

Income is the lifeblood of an economy. When too much goes to the head, it has a stroke.

Meanwhile, the Republican candidates at their debate this week blindly dismissed the struggles of the lower and lower middle classes. So did the president with his veto of S-CHIP, and the right-wing echo chamber with its assault on a 12-year-old child from a struggling middle class family that dared to take advantage of the government program.

The next economic downturn will reveal all these factions for what they are: cranks on the fringe. I just completed reading "The Big Con" by The New Republic writer Jonathan Chait. He dissects how the media's failure to take ideas and policies seriously allowed supply-side economics, which offered the panacea of tax cuts in every season, to achieve political legitimacy. We're about to learn again how wrong those people are, at great pain and cost to the bottom half of the American population.

Costs, Not Just Uninsured, Worry Republicans

A story in this morning's Wall Street Journal pointed me in the direction of something interesting polling data released in August by the Kaiser Family Foundation. Health care, as was reported widely, was the second most important issue to most Americans after the war in Iraq, with 27 percent of the public thinking it the most important issue needing to be addressed by the government.

But if you break that down, the poll showed that concern had very different emphases depending on political affiliation. Democrats thought covering the uninsured and making health insurance universal was more important than controlling costs by a three-to-one margin. But Republicans who thought controlling costs was more important slightly outnumbered their colleagues who worried more about covering the uninsured. The independents came out somewhere in between.

This helps explain why the Republicans are ignoring the plight of the uninsured in their debates. But that won't last once they're past the primaries. Nearly twice as many people overall are more worried about the uninsured than costs, including a slight majority of the independents. The candidate who scores on this issue in the general election will have to address both issues.

The most startling fact from the poll was the widely differing response to the threat of terrorism. Just three percent of Democrats thought it the most important issue, compared to 22 percent of Republicans, for whom it was the second most important issue after Iraq. This lack of Democratic concern made it rank fifth overall in the poll with just 11 percent of the electorate citing it as their most important concern, trailing behind, in order, Iraq (42 percent), health care (27 percent), economic issues (16 percent), and immigration (13 percent).

Common Sense on Personalized Medicine, Stress

Two thought-provoking commentaries appeared today in the Journal of the American Medical Association, one questioning the long-term significance of genomic information in personalizing health care, and the other stressing the role that stress plays in causing disease.

University of Washington researchers Wylie Burke and Bruce Psaty suggest that minor genetic differences between people account for very few cases of common diseases. The most famous example, the BRAC1 and BRAC2 mutations that are associated with just 15 percent of breast cancer cases, is far more prevalent than most genetic markers. Most are associated with just a few percentage points of a disease. The authors conclude:

Given the uncertainties of risk prediction and the small effect size of most genetic risk factors for common diseases, predictive genetic testing is likely to play only a modest role in the prevention of these diseases, with relatively little medical care improved by knowledge of a patient's genetic profile.

They conclude their essay with a plea for doctors to return to the real personalized medicine -- the indispensable one-on-one care that provides psychic relief along with professional care.

Sheldon Cohen of Carnegie Mellon University and colleagues, meanwhile, find that major life events like natural disasters, economic downsizing and bereavement increase the likelihood of depression, cardiovascular disease, progression to AIDS for HIV-positive people, and cancer. They call for clinical trials showing that reducing these stressors reduce disease.

While it is welcome that an article in JAMA aimed at the nation's physicians recognizes the role that social conditions play in promoting disease, anyone who has paid attention to the studies knows that income inequality and class status are negatively correlated with health and longevity. But do we really need more clinical trials to prove that interventions work, or do we need social programs that reduce the stress that promotes disease?

What people in New Orleans needed was a FEMA that worked, not another clinical trial showing that people who lose their homes and get no help get sick and die at much faster rates than those for whom care is provided.

Fighting Malaria -- Free Distribution of Bednets Best

A few months ago, a study appeared in PLOS Medicine showing that free distribution of bednets to prevent malaria in poor countries worked better than charging a small fee. The idea behind the latter program, sometimes called social marketing, is that poor people will place a greater value on and make greater use of the bednets if they have to pay something for them.

Responding to the study, the World Health Organization in mid-August officially endorsed free distribution of bednets to all poor people in malaria-endemic countries, a change from the prior policy which only gave them out free to children under five. The policy put the WHO at odds with the Bush administration, whose malaria initiative had focused on social marketing of nets.

Today's New York Times covered the growing success of the movement toward free bednet distribution, based on reporting by a Kenya-based stringer. The story included a quote from Sen. Tom Coburn, the Oklahoma Republican with close ties to the parts of the evangelical Christian movement that has made combating malaria part of its missionary work. He called free distribution "a great move" by the WHO. "We knew social marketing doesn't work."

The story, curiously, did not report if policy is shifting at the President's malaria intiative in response to the study and WHO directive. Here's a situation where the administration's free-market ideology is at odds with the position of its Christian fundamentalist base. It will be interesting to see if Christ and science win out over mammon.

Meanwhile, the Washington Post plays catchup with the Los Angeles Times in reporting on the DDT-breast cancer link, which also has implications for malaria control now that the pesticide is making a comeback. You can find a link to the original story here.

Big Tobacco and Lung Cancer Screening

The National Institutes of Health is in the midst of a $200 million trial to determine if routine CT scans of smokers' and former smokers' chests can identify lung cancer in its earliest stages and save lives through early intervention. The Wall Street Journal reports this morning (subscription required) that two of the researchers involved in the study recently served as paid experts for tobacco companies in civil suits brought by patients who want the tobacco industry to pay for the screenings.

The issue was raised by the Washington-based Lung Cancer Alliance, which supports screening. This patient advocacy group, the story notes, has received $100,000 from General Electric, which would profit from a massive expansion in cancer CT scans.

The House Energy and Commerce Committee has launched an investigation into the conflicts of interest, and whether the researchers who designed the NIH study tilted its design in ways that would discourage mass screening. There are about 90 million smokers and ex-smokers in the U.S.

Like all cancer screening tests, lung cancer screening would inevitably turn up thousands -- perhaps millions -- of suspicious-looking abnormalities. Biopsies would get done. Surgeons would operate. Drugs would get taken. Costs would skyrocket. The cancer rate, obviously, would rise, since more cancers would be found earlier. And the survival rate -- defined as persons living at least five years with the disease -- would probably improve.

But would it have done anything for overall lung cancer mortality? Perhaps not. There is no evidence that earlier intervention for this disease saves lives, and living longer with the knowledge that you're going to die from lung cancer -- even if it goes over the arbitrary five-year time frame -- isn't much of a benefit.

The two researchers with ties to Big Tobacco are University of California Los Angeles radiologist Denise Aberle, who testified in a 2003 case in Louisiana on behalf of American Tobacco Co., and Dartmouth College radiologist William Black, who testified in a New York case for Philip Morris. Aberle, one of the national leaders of the NIH trial, said UCLA got the money from her testimony and Black subsequently ended his relationship with tobacco companies.

NIH defended using scientists with previous ties to the tobacco industry:

In a written response to the Lung Cancer Alliance, the NCI said the expert witness work was appropriate. "Service as an expert witness, presenting independent analyses based on published medical literature, is a commonly accepted activity for physicians, researchers, and other experts and in the instance of the specific circumstances described did not violate the required disclosure guidelines of the organizations involved," NCI director John Niederhuber wrote.

Moreover,

In an interview, an NCI spokesman said the institute has no way of knowing whether any other investigators in the 30-center study have financial ties to tobacco or scanning companies because it does not examine such potential conflicts.

So there you have it. Rival industrial interests are funding researchers and patient advocacy groups who square off over the utility of a wildly expensive technology of questionable benefit, and NIH turns a blind eye to how conflicts of interest might undermine its much-needed objective study of the issue. This is a classic example of everything that ails the health care technology assessment field, made more graphic by the presence of the tobacco industry, everybody's favorite whipping boy and for good reason.

The steps forward are clear. Congress should create a new institute to test new technologies and compare them to existing technologies, a move that has been endorsed by leaders from both political parties. The new agency must scrupulously avoid all conflicts of interest, with industrial interests kept as far as possible away from the decisions of what to study, how to design the trials, and how to interpret the results. And, the researchers who conduct the studies must follow a simple rule: You can't have had any financial conflict of interest within the past five years to participate in such a study.

Meanwhile, NIH must end its laissez-faire attitude toward monitoring the conflicts of interest of the extramural researchers based at the nation's universities, who absorb 80 percent of its annual $30 billion budget. Universities have proven that they're aren't up to the task of monitoring their professors. Indeed, the commercialization imperative that now dominates thinking at most major universities (they earn revenue from licensing the patents that come from NIH-funded research) has created a structural conflict of interest that has blinded them to improprieties like what just took place at UCLA in the CT study.

NIH catalogues every extramural research grant in a database that is open and available to the public (it's called the CRISP database for those who want to google it). One of the fields in that database should include a complete disclosure by the grantee of all industry affiliations and financial conflicts of interests over the past five years. That will make it much harder to hide the kind of conflicts of interest that now cloud this $200 million cancer screening trial.

The results of the trial are due in 2009. Should it show that screening is not worth the candle, the trial will undoubtedly be seen as fatally flawed by patient advocates, who have their own conflicts of interest.

NIH insists the trial is well-designed. But when it comes to conflicts of interest, appearances matter. The expenditure of $200 million in taxpayer money should have resulted in a definitive answer. Now all we'll get is endless bickering over the meaning of the results by self-interested parties whose first line of attack will be the financial ties of the researchers or advocates on the other side.

NIH has once again been caught with its pants down on the conflict-of-interest issue. It should move quickly to change its rules. Besides disclosure, it should not allow researchers to participate in the major technology assessment trials that the agency funds if those researchers have relevant conflicts of interest.

And the agency should set up an independent committee to review whether all investigator-driven trials funded by the federal government should have similar restrictions. The argument against this radical step is that it will divide the world of research into two camps: those who take money from industry and those who don't. Maybe that isn't such a bad idea.

Microsoft Jumps on the Health IT Bandwagon

Microsoft launched a public relations offensive today as part of the unveiling of its new online health records service, HealthVault. Bill Gates, never one to shy away from a business opportunity, offered the conventional wisdom on the Wall Street Journal's editorial page:

By giving us comprehensive access to our personal medical information, digital technology can make us all agents for change, capable of pushing for the one thing that we all really care about: a medical system that focuses on our lifelong health and prioritizes prevention as much as it does treatment.

But as he pointed out earlier in the piece, "Already, nearly all procedures, test results and prescriptions are recorded in digital form -- that's how health-care providers transmit information to health insurers so they can be paid for their work. But patients never see this data, and doctors are unable to share it." Ditto for Medicare, the biggest insurer of them.

So, then, isn't it a simple task to insist that these electronic medical records be made available upon request to patients and other physicians (with patient approval)? Isn't it a simple task to pass a law that requires all physicians, hospitals and clinics transition to patient-available electronic medical records with portability if they wish to continue collecting fees from Medicare, Medicaid and other government programs, which account for nearly half of all direct health care expenditures?

There would be a front end cost to the transition, of course. But in a country that spends over $6,000 per capita on health, is it unreasonable to budget, say, $100 a record for switching to electronic records? In a country with 300 million people, that's $30 billion. Spread it over five years and the cost is barely noticeable, and significantly below what health insurance companies make in profit every year.

There are interoperability and data reporting standards that have to be resolved. But instead of having every potential vendor reinvent its own wheel, a logical way to proceed would be to universalize the system created by the Veterans Administration, which blazed the trail in electronic recordkeeping.

Strict privacy policies with powerful sanctions for violators must be enacted and enforced. Extra help for making the transition may have to be offered to solo practitioners or health services offered in poor areas. But the surest way to get to universal electronic medical records is to pass a law requiring it. If the nation waits for competing marketplace forces to solve this problem, it will lag behind standards that are already in place in Europe for another generation.

The Shifting Politics of Health Care

The landscape of medicine is shifting rapidly as efforts to reform the health care system gather steam. Long-time political alliance and positions are in flux as major players prepare for a change in administrations.

Two straws in today's wind. First, the president's veto yesterday of the State Children's Health Insurance Program expansion drew strong condemnation from the American Hospital Association (hospitals) and the American Medical Association (doctors), but not America's Health Insurance Plans (insurance companies) or the Pharmaceutical Research and Manufacturers Association (drug companies), which did not issue press releases. In AHIP's case, it had praised the Senate bill when it passed last August, but it was noticeably quiet yesterday.

Why? No doubt the insurance and drug companies are bracing for more Democratic legislative assaults on the health care front in the waning days of the Bush administration, and they are banking on the veto pen to bail them out of any incremental changes that would jeopardize their short-term bottom lines. Better to fight for their corporate needs in the context of a major health insurance overhaul, where they can quietly craft provisions with friendly legislators that protect their long-term interests.

But wiser heads in those sectors know change is coming. I was intrigued this morning by comments made by Eli Lilly CEO Sidney Taurel at the Cleveland Clinic earlier this week (reported by FDA Webview, subscription required). He called on government and industry to collaborate on a health information technology system "to provide more rapid and useful insights on drug effectiveness and improve drug safety."

A well-functioning health IT system could not only frame hypotheses for post-marketing Phase 4 research studies but also be the practical equivalent of massive real-world trials. Such a system, he said, would collect detailed data from day-to-day medical practices and feed insights quickly, seamlessly, and at a lower cost to doctors, regulators, and drug manufacturers. . . “Such reform will allow us to speed up the recognition of safety signals and understand the true efficacy of new medicines more quickly,” he said.

But, as can be seen from the Medicare registry of implantable cardioverter-defibrillators (see yesterday's GoozNews post), such data will also give patients and their insurers a tool for studying how well those drugs and devices are performing in the real world. One of the great promises of universal electronic recordkeeping is that it will enable researchers to study how much benefit new technologies actually provide the general population that visits physician offices, clinics and hospitals, where economic incentives often trump medical science.

As we've seen time and time again, real world prescribers do not behave like the prescribers who participated in the limited clinical trials that led to a drug or device's approval. Their patients are usually younger or older, sicker or healthier, or women and minorities who are underrepresented in clinical trials. The efficacy seen in a clinical trial often disappears in the world of actual medical practice. Those interventions all too often are, in short, waste.

Universal registries enabled by a comprehensive health information technology system could become a powerful tool for rolling back the hundreds of billions of dollars of waste that is dragging down our health care system and making health insurance -- whether provided by the government or private companies -- unafffordable.

Shocking News on ICDs

One of the great shames of the U.S. health care system is that women and minorities routinely receive less care than white men. This is especially true for women and blacks suffering from heart disease. They're much less likely to be offered complicated procedures like stents, bypass surgery and implanted defibrillators.

Guess what? They may be the lucky ones, at least when it comes to implantable cardioverter-defibrillators (ICDs), for which Vice President Dick Cheney is probably the most famous patient.

A new study in the Journal of the American Medical Association shows that black men were only 73 percent as likely as white men with a comparable level of disease to get ICDs; white women were only 62 percent as likely, and black women were only 56 percent as likely to get the devices implanted.

The study used the first data in from the registry required by the Center for Medicare and Medicaid Services (CMS) when it expanded the use of ICDs, much to the chagrin of some of the advisers on the panel that evaluated the technology two years ago (see this GoozNews). The billion dollar question at the time (the devices cost about $40,000 per operation) was whether Medicare beneficiaries would have the same benefit as the patients who were enrolled in the original clinical trials, who were younger and (other than the fact they had heart disease) healthier.

This new study also looked at outcomes and, according to an accompanying editorial by Rita Redberg, a cardiologist at the University of California at San Francisco who served on the CMS advisory panel, the results "are troubling, but not for the expected reasons."

After controlling for comorbidities, the authors found that Medicare beneficiaries who received ICD implants for primary prevention had no benefit in terms of reduced all-cause mortality. In other words, the bad news may not be for women and minorities, but for white men who are undergoing a procedure that, for primary prevention, has not been shown to extend lives.

So much for the world of evidence. Now let's turn to news from the evidence-free zone, i.e., where medicine actually gets practiced. All last year, sales of ICDs were depressed because of safety concerns surrounding product recalls by Guidant, which is owned by Boston Scientific. But they're rebounding smartly, according to the financial press.

Medtronic, whose ICDs are its largest product line, said sales rose 8 percent from a year ago in the second quarter, according to its most recent report. St. Paul-based St. Jude Medical, the third largest maker, said that its sales of ICDs spiked 18 percent to $327 million in the second quarter. And Boston Scientific? Its ICD sales were down, but only slightly to $377 million from $383 million.

Do the math. About $1 billion a quarter in sales for the three makers. That's $4 billion a year just for the devices (this doesn't include the hospital and physicians payments, don't forget). Most of it probably comes from Medicare.

Let's give Dr. Redberg the last word:

Thus, the multibillion-dollar question is: Are too few ICDs for primary prevention being implanted in women (and minorities) or are to many ICDs being implanted in (white) men? The important clinical and policy question may be not why women and black Medicare beneficiaries are less likely to get an ICD, but which Medicare beneficiaries will benefit from ICD at all?

Fatter, More Smokers = Higher Costs

Americans are fatter and smoke more than Europeans, and the health care system more aggressively screens and treats for disease, especially cancer. Those two factors working in tandem add $150 billion a year to the nation's health care tab and are one reason why health care costs are so much higher here than in the rest of the world, a new study on the Health Affairs website claims.

Lead authored by Emory University public health specialist Ken Thorpe, who is emerging as a lead Health and Human Services secretary candidate for the next Democratic administration, the study takes aim at the conventional wisdom that high prices, high technology and high utilization rates are the main reasons for higher health care costs here.

Chronic disease risk factors such as obesity and smoking rates are higher in the United States than in the ten European countries we examined. According to the self-reported data in 2004, 33.1 percent of U.S. adults age fifty and older were obese, compared with 17.1 percent in ten European countries . . . Obesity prevalence among the European countries ranged from a low of 6.6 percent in France to a high of 23.3 percent in Spain. Cigarette consumption, like obesity, is associated with increased risk of a number of the conditions we examined. According to the (data), 53 percent of Americans age fifty and older had smoked or were current smokers, compared with only 43 percent in the European countries. These results are consistent with historical comparisons of U.S.-European smoking patterns.

As a result, the prevalence of heart disease, hypertension, high cholesterol and diabetes were much higher in the U.S. and cancer rates were shockingly twice the level of the European countries considered (12.2 percent versus 5.4 percent). In part, the authors speculate, that is due to more aggressive care of mild or asymptomatic disease. "Are Americans really more likely to develop malignant tumors, or are they just screened more intensely than Europeans are? Comparisons of breast cancer screening rates and five-year cancer survival rates suggest the latter," they write.

Still, that doesn't account for all of the higher cancer rates here, which, like diabetes and heart disease, are closely associated with obesity rates. Higher U.S. prevalence of obesity-related disease "suggests that measures to design to prevent these conditions could yield lower spending in the U.S."

The Failure of FDA Reform

The Guardian (UK) just posted my analysis of the Food and Drug Administration reform bill that President Bush signed into law last week. You can read it on the Comment Is Free section of their website.

DDT-Breast Cancer Link Found

A study suggesting that there is no link between DDT use and rising breast cancer rates on Long Island got a lot of attention a few years ago from conservative groups pushed for increased DDT use to kill mosquitos to curb malaria in the developing world. Now this story based on this study suggests that California women exposed to DDT in their prime childbearing years may have four times the breast cancer risk of unexposed women. This controversy isn't going away anytime soon. As a precautionary measure, global health authorities should encourage the use of alternatives wherever possible.

Class and Health

Maggie Mahar at the Century Foundation, who writes the Health Beat blog, posted this last week after an important article by Dr. Steven Schroeder on the relationship between class and health appeared in the New England Journal of Medicine. I thought it worth reposting:

When compared to other developed countries, the U.S. ranks near the bottom on most standard measures of health. Many people assume that this is because the U.S. is more ethnically heterogeneous than the nations at the top of the rankings, such as Japan, Switzerland, and Iceland. But while it is true that within the U.S. there are enormous disparities by race and ethnic group, even when comparisons are limited to white Americans our performance is “dismal” observes Dr. Steven Schroeder in a lecture published in the New England Journal of Medicine yesterday.

Why? It’s not the lack of universal access to healthcare" says Schroeder, though that’s important. And it’s not just that we don’t exercise enough and eat too much—though that is a major cause. But there is one factor undermining the nation’s health that we just don’t like to talk about in polite society: Class. When it comes to health, class matters.

Schroeder, who is the Distinguished Professor of Health and Health Care at the University of California San Francisco (UCSF) underlines how poorly even white Americans stack up when compared to the citizens of other countries by pointing to maternal mortality as one measure of health. When you look at “all races” you find that in the U.S. 9.9 out of 100,000 women die during childbirth. Focus solely on white women, and the number is still high—7.2 deaths out of 100,000 –especially when compared to Switzerland where only 1.4 women out of 100,000 die while giving birth.

Statistics on infant mortality reveal the same pattern: among “all races” 6.8 American children who were born alive die during infancy; limit the analysis to “whites only” and 5.7 infants die—compared to just 2.7 out of 1,000 in Iceland. .) When researchers compare maternal mortality and infant mortality in white America to rates of death in the 29 other OECD countries, white America ranks close to the bottom third in both categories.

Turn to life expectancy, and you find that white women in the U.S. can expect to live 80.5 years, only slightly longer than American women of all races (who average 80.1 years). Both groups lag far behind Japanese women (who, on average, clock 85.3 years). The gap between “all American men” (who live an average of 74.8 years) and white men in the U.S. (75.3 years) is wider—but not as wide as the gap between white men in the U.S. and men in Iceland (who live an average of 79.7 years).

“How can this be?” asks Schroeder. After all, as everyone knows, the U.S. spends far more on health care than any other nation in the world.

The answer is a stunner: the path “to better health does not generally depend on better health care,” says Schroeder. “Health is influenced by factors in five domains — genetics, social circumstances, environmental exposures, behavioral patterns, and health care. When it comes to reducing early deaths, medical care has a relatively minor role. Even if the entire U.S. population had access to excellent medical care — which it does not — only a small fraction of premature deaths could be prevented.” [my emphasis]

Schroeder goes on to emphasize the importance of behavior, and talks about smoking and obesity—problems that we have discussed on this blog. Then he turns to the causes of poor health that we tend to ignore: “the nonbehavioral determinants of health.

Here Schroeder points to an overwhelming amount of research (see here, here, and here) which confirms that people living on the lower rungs of the socioeconomic ladder die earlier and suffer from more disabilities than those who are wealthier, better educated, have a better job and live in a better residential neighborhood (the four components that researchers use to define “class”) Moreover, he notes, “the pattern holds true in a stepwise fashion from the bottom of the ladder to the top.”

But isn’t the difference really a function of individual behavior? After all, everyone knows that poorer, less well-educated people are more likely to smoke and eat junk food. Schroeder acknowledges that this is true: “people in lower classes are more likely to have unhealthy behaviors, in part because of inadequate local food choices and recreational opportunities.” In poorer neighborhoods, fresh and organic foods are usually unavailable or exorbitantly expensive; public recreation is often nonexistent, and exercising outdoors can be dangerous.

“Yet, Schroeder points out, even when behavior is held constant, people in lower classes are less healthy and die earlier than others. [my emphasis]. For example, a 1996 study published in the American Journal of Public Health which focuses on white American men –and takes smoking and other risk factors into account-- reveals that men earning less than $10,000 were 1.5 times as likely to die prematurely as were those earning $34,000 or more.

In the U.K., a similar study of British civil servants showed that when smoking and other risk factors were controlled for, those in the lowest employment category were still more than twice as likely to die prematurely of cardiovascular disease as were those in the highest category.

Why? Schroeder points to a combination of “material deprivation” and “psychosocial stress.” Being poor generates terrible anxiety, not just about money, but about safety, your family’s safety, and the fact that catastrophe—in the form of losing your job and losing your home—is always just around the corner.

Within the world of medicine, while some attention has been given to racial disparities in health and health care, the importance of class, and “the wide differences in health between the haves and the have-nots are largely ignored,” Schroeder observes in a 2004 NEJM article that he co-authored with Stephen L. Isaacs J.D. Clearly, he stresses addressing racism should be a priority: “to bring about a fair and just society, every effort should be made to eliminate prejudice and discrimination.” And often, he admits, it is hard to “disentangle” race and poverty. But he argues “concentrating mainly on race as a way of eliminating these problems of premature death, illness and disability among the poor downplays the importance of socioeconomic status on health.”

“The focus on reducing racial inequality is understandable since this disparity, the result of a long history of racism and discrimination, is patently unfair,” Schroeder continues. “Because of the nation's history and heritage, Americans are acutely conscious of race. In contrast, class disparities draw little attention, perhaps because they are seen as an inevitable consequence of market forces or the fact that life is unfair. As a nation, we are uncomfortable with the concept of class. Americans like to believe that they live in a society with such potential for upward mobility that every citizen's socioeconomic status is fluid. The concept of class smacks of Marxism and economic warfare.” [my emphasis]

Here let me add, as an aside, that I have asked a physician who is an expert on racial discrimination and health care to send me a post for this blog. I hope to publish her comment soon.

But today, I’m focusing on the socio-economic factors which influence the health of Americans of all races because in some areas class trumps race. For example, while African-Americans have higher rates of death from heart attack than do whites at all levels of income--and the poorest Americans, whatever their race, have substantially higher rates of heart attack than those who are better off --the difference in the rates of premature death from heart attack between poorer and richer people is far greater than the difference in the rates of premature death between blacks and whites.

But how does class explain why the U.S.lags so far behind other developed countries when we look at markers like maternal mortality and life expectancy? After all, the U.S. is not the only country where class matters. Here, Schroeder points to an uncomfortable fact: “nations differ greatly in their degree of social inequality.” [my emphasis] And in the U.S., in recent decades, the gap between the haves and the have nots has widened, to a point that we have become a divided nation.

Wages at the top of the ladder have spiraled while wages in the lower rungs have flattened or even fallen. Meanwhile tax policies have favor the rich, particularly in the 1980s, under President Reagan, and in recent years, under the current administration. Even in the late 1990s, during President Clinton’s last term, the wealth of a prosperous economy did not trickle down: between 1997 and 2001 the top 10 percent of U.S. earners received 49 percent of the growth in real wages and salaries; and the top 1 percent reaped 24 percent of the total while the bottom half of workers received less than 13 percent.

Granted, inequality was growing in most of the rest of the world over the same span, “but the United States led among the richer nations; and unlike most others that offset market inequality though government intervention, the United States has not done so,” observes William K. Tabb, author of Economic Governance in the Age of Globalization.

This may say something about our priorities as a nation. “One reason the United States does poorly in international health comparisons may be that we value entrepreneurialism over egalitarianism,” Schroeder notes. “Our willingness to tolerate large gaps in income, total wealth, educational quality, and housing has unintended health consequences. Until we are willing to confront this reality, our performance on measures of health will suffer.”

Yet, he suggests, we could do better, first by recognizing how social policies involving education, taxation, transportation and housing have important health consequences and by analyzing the impact of these policies on health.

Moreover, when it comes to health policy, he observes, we need to focus on the social and environmental factors which affect the health of the less fortunate people in our society.. Instead, in a nation where health care has become big business, we pour the bulk of our health care dollars into “the development of new medical technologies and support for basic biomedical research. We already lead the world in the per capita use of most diagnostic and therapeutic medical technologies,” Schroeders notes, “and we have recently doubled the budget for the National Institutes of Health. But these popular achievements are unlikely to improve our relative performance on health [when compared to other countries.] “

Perhaps our health care policy reflects our values. “It is arguable that the status quo is an accurate expression of the national political will,” says Schroeder “a relentless search for better health among the middle and upper classes. [my emphasis]. This pursuit is also evident in how we consistently outspend all other countries in the use of alternative medicines and cosmetic surgeries and in how frequently health "cures" and "scares" are featured in the popular media. The result is that only when the middle class feels threatened by external menaces (e.g., secondhand tobacco smoke, bioterrorism, and airplane exposure to multidrug-resistant tuberculosis) will it embrace public health measures. In contrast, our investment in improving population health — whether judged on the basis of support for research, insurance coverage, or government-sponsored public health activities — is anemic.”

And yet, and yet . . . Schroeder sees reason for “cautious optimism.” Although we trail behind other countries, we are healthier than we once were. We have reduced smoking ratse, homicide rates and motor-vehicle accidents. Vaccines and cardiovascular drugs have improved medical care. But progress in other areas will require “political action,” Schroeder declares, “starting with relentless measurement of and focus on actual health status and the actions that could improve it. Inaction means acceptance of
America's poor health status.”

If we got serious about improving public health we could improve productivity, boost the economy, rein in health care spending and “most important, improve people’s lives” Schroeder argues. Here, he calls on physicians and other healthcare professionals to become “champions” for public health. In the end though, it is not only health professionals, Schroeder suggests, but all Americans who should see improving the health of the nation as a matter of patriotism. “Americans take great pride in asserting that we are number one in terms of wealth, number of Nobel Prizes, and military strength. Why don't we try to become number one in health? “