CMS Scales Back EPO Decision

The Center for Medicare and Medicaid Services yesterday released its final decision on the use of anti-anemia drugs in cancer patients. Bottom line: It will scale back use of the drugs, collectively known as EPO, somewhat. Pressure from Capitol Hill and the medical community (the agency received more than 2,600 comments, many of them organized by Amgen and J&J, which make the drugs) got the agency to withdraw some of the limitations that had been proposed last May. Recent studies have shown that overusing EPO may actually make cancers grow faster.

While a stock analyst told the New York Times that CMS "blinked," even he had to admit that the new policy would result in a “significant reduction” in use of the drugs.

The most significant changes: EPO can only be used for the anemia associated with chemotherapy, not the anemia associated with cancer itself; and the onset of therapy should only begin when red blood cell counts fall below 30 percent of blood volume. While that's above the 27 percent level initially set in May, it's still well below the level at which many doctors began infusing EPO in recent years. Both companies gave out hefty financially rewards to physicians who used more of the drugs, known as Aranesp and Procrit.

Brits Jump Into Avastin-Lucentis Controversy

The Guardian in the UK reports this morning that its National Health Service will also sponsor a clinical trial comparing Avastin to Lucentis for macular degeneration. Medicare recently changes its rules so that it can financially support a similar National Institutes of Health trial in the U.S. (see this GoozNews).

The movement toward governments sponsoring comparative effectiveness research to lower costs is gathering steam.

On the High Price of Cancer Drugs

Today's New York Times has a good story on the unevenness of cancer care around the country, and how insurers play a major role in what type of care cancer patients get. I recently received an email query from a journalist doing an article about cancer drugs and their rising pricetags. My response, reprinted here, sheds light on some of the issues not covered in the Times' front page story, but relevant to discussions about unevenness in care:

Cancer remains the great conundrum of modern medicine.

Despite more than a half century of intensive research and development by both the public and private sectors, we have yet to make major advances against most of the more than 100 forms of the disease. Average life expectancy (measured as cancer patients who survive for at least five years after diagnosis) has gone from about half of all patients three decades ago to about 60 percent today.

Scientists have made incredible strides against some forms of the disease: several forms of leukemia, testicular cancer, some forms of breast cancer. Screening has helped millions of people identify others early on -- cervical cancer and colon cancer, for instance -- which is when they are most treatable. But for many other solid tumor cancers -- of the lung, pancreas or liver, for instance -- detection is only the point at which one learns one has an incurable disease.

I once heard the traditional weapons used in cancer therapy described as knives, flamethrowers and poison. Or, to use the medical terminology, surgery, radiation and chemotherapy. Many patients get all three. And the success of those weapons is measured by extending the life expectancy of the person diagnosed with cancer. For a percentage of patients (how big depends on the form of cancer and how early it is detected), it can even be a cure. But for most, success is measured by postponing the inevitable. Cancer therapies are approved today that extend life by a few months. Few quarrel with that standard when new drugs come before the Food and Drug Administration. After all, one day it may be you having your life extended.

But when patients are told about these new drugs, the tradeoffs remain deeply troubling. Patients and doctors are very aware of the quality of life of people undergoing extensive chemotherapy after surgery and radiation. And when it is not successful in terms of a cure but has succeeded in slowing the cancer's progression, the end stage is still marked by extensive pain and physical deterioration. Pain management is a major issue in end-of-life cancer patient care. So, in practical terms, if a patient is told that taking Drug A after surgery and radiation may give you a chance of living 15-18 months instead of 4-12 months (hypothetical example), that person must weigh whether they want to put up with a year of multiple chemo treatments with their side effects (nausea, hair falling out, etc.) versus the extra time.

Most choose the extra time since there is always the hope that they be among the lucky ones for whom treatment succeeds. But for most, that hope is only that. In the majority of cancers not caught early in their development, mutant cells have broken away from the solid tumor and have landed somewhere else to relaunch the cancer in another organ.

The latest generation of cancer drugs -- targeted therapies -- is a product of the last quarter century's heavy public sector investment in biomolecular research, and holds out hope of changing the cancer treatment paradigm. After President Nixon launched the war on cancer in 1971, the U.S. began investing heavily in understanding cell interactions at the molecular level. From Harold Varmus' discovery of the first oncogene (the particular genes that go wrong when cancers strike) to the human genome project, we now have a much better understanding of how cells work and what goes wrong when cancer strikes. The result is that there are many targets on cells that new drugs can aim to inhibit.

Sometimes a new drug aimed at these targets works, and because they are targeted inhibitors, not cell killers, they are much less toxic than chemotherapy. But, sadly, it turns out that most of the new targeted therapies are no more effective than traditional chemo drugs. Fast-growing cancer cells are mutating all the time, and the laws of population genetics means those that survive in the new environment (the presence of the drug) will be those that are resistant to the drug. Over time, that becomes the dominant strain of the cancer. The result? Many of the new targeted therapies only slow the rate of cancer growth by a few months (Iressa, for lung cancer, was the classic case).

Another new class of targeted drugs are the anti-angiogenesis drugs like Avastin. These inhibit the formation of new blood vessels to feed the cancer. It's a great idea, first propounded by Judah Folkman. But cancers are fast-growing beasts and it appears to overwhelm the anti-angiogensis effect after a while. Avastin has proved to be much more effective at curbing macular degeneration (explosion of blood vessels in aging eyes) than in arresting cancer.

Now we finally get to the economics of all this, which are, to say the least, daunting given the prices the drug companies are setting on these new targeted therapies. Say before the arrival of a new targeted therapy you have a cancer where the median survival time is 24 months. That means you will probably live somewhere between six months and five years (hypothetical) after taking traditional chemo drugs in the wake of surgery and/or radiation. A few patients will even be cured, say 20 percent, the definition being that they survived five years.

Now a new targeted therapy comes along aimed at this cancer. It turns out that the drug raises the median survival time to 27 months even though the general shape of the bell curve and survival rate stay the same. In other words, more patients are living longer, but the underlying dynamics of the disease really hasn't changed. This is definitely FDA approvable. And the company, with FDA license in hand, decides this is worth $10,000 a month.

Let's do a cost-benefit analysis of this drug. If we look at all patients taking this drug as a group, we find that their life expectancy has been extended by three months on average. Given that the average person in the group will be taking the drug for over two years, that amounts to nearly a quarter million dollars in extra medical expenses per patient. That means patients' insurers are paying $1 million per additional year of life.

Most European health care systems balk at that level of expense. But in America, Medicare cannot use cost-effectiveness analysis to limit drug use. They are bound by a "reasonable and necessary" standard. If it extends life, that's reasonable and necessary, period.

Which approach is correct? I ask myself: what if it were me? Confronted with a likely death sentence, knowing everything that I know and have seen about cancer therapeutics, I have no idea how I would respond if my doctor told me tomorrow that I had a virulent form of the disease. Because I a fairly well informed consumer, my instinct is to say I would study the literature on all the potential approaches and reject those that seem like their benefits don't add enough to justify the pain (side effects) and cost.

That's easy to say when I'm in perfect health. But maybe I'd have a completely different attitude when given the hope that taking this expensive drug would potentially give me at least another three months (and maybe more) to visit with my grandkids.

Which brings me to my real bottom line when it comes to the new, targeted therapeutics for cancer. Isn't the real issue that $10,000 per month pricetag? Isn't what we really need is a better way to develop drugs so that they are affordable?

Drug Cos.: Disclose Charitable Gifts

An international coalition has called on the drug industry to begin public posting of its gifts to non-profit and charitable organizations. It's an effort to expose companies that use these groups as front organizations for promoting their wares and/or supporting their policy initiatives. The letter, organized by Essential Action, noted:

Public health organizations have also repeatedly confronted industry-allied think tanks and advocacy groups that advance industry-favored policies -- for example, in op-ed pieces -- without disclosing their industry ties.

The letter was sent to the heads of 15 major drug companies and the two major pharmaceutical industry associations. Eli Lilly began posting its charitable donations and educational grants earlier year. Another company that posts its grants to non-profits is ExxonMobil, which for years has been a major financial supporter of global warming skeptics.

Geron: Where's the Stem Cell Beef?

The blog on the Wired Magazine website had a great post earlier this week on Geron's failure to take any of its vaunted stem cell therapies into clinical trials. Geron, you'll recall, funded University of Wisconsin researcher's James Thomson's seminal work on isolating embryonic stem cells, and licensed its most promising uses. That patent, held by the Wisconsin Alumni Research Foundation (WARF), was recently challenged by the Patent and Trademark Office, a challenge backed by several consumer groups. The Wired blog post provides ample evidence as to why it would be a good thing if WARF and Geron lose their battle to hold onto exclusive rights to embryonic stem cells' most promising uses.

Newspaper Industry Death Watch

As some of my readers know, I spent a quarter century in the news business (more if you include the time I spent throwing newspapers up on lawns as a kid). I started at age 19 in the composing room (when newspapers still had them) and had the privilege of working among some of the best in the profession while serving as a foreign and Washington-based correspondent. I care deeply about newspapers, and still read three or four every day.

So I couldn't help but notice the bad news on the business page today. Profits at the New York Times Co. and the Tribune Co. were down again. The Times is planning to triple its cost-cutting in the next two years, the report said. At the Tribune, according to the Wall Street Journal, publishing revenue dropped 9% to $920 million. Ad revenue fell 11%. Online revenue rose 17% to $66 million. Circulation revenue fell 6%."

Allow me to deconstruct those numbers a bit. The decline in ALL revenue was greater than ALL internet revenue combined. In other words, for every $8 decline in print revenue, the company picked up $1 in internet revenue.

We're at the peak of a business cycle (with many recessionary winds blowing, but that is another story). Advertising has always been a coincident indicator, in other words, it rises and falls in tandem with the overall economy. Advertising dollars are migrating away from print to the internet, broadcasting and other sources like direct mail. Companies like Google and Yahoo are rolling in cash.

But they hire very few journalists (if any). And those they do hire have very few standards. I had lunch yesterday with a former reporter trying to raise a little money to catch on at a univeresity (apparently the people who get teaching jobs now are the ones who can raise their own salaries, and pay a 50 percent kickback to the university).

She had done a bit of freelancing for a mainstream newspaper and an internet outlet. The former paid about 40 cents a word; the latter paid about 10 cents a word. I can remember earlier in this decade (when I was doing much more freelancing than I am now) that I could get $2 a word from some outlets, and $1 from unprofitable (usually non-profit political mags) ones. It appears that internet economy is collapsing payscales, too.

Which brings me to my final complaint of the morning. I get something called the Alternet in my in-box every day. It is a bunch of stories from a progressive point of view, many of them from well known names like Amy Goodman or Barbara Ehrenreich. But it also has a lot of young journalistic talent who are getting their initial training in the field by publishing on this site. All well and good.

But today's banner headline involved a shriek about how hedge-fund short-selling could lead to a great crash like 1929. With today's stock market acting kind of wobbly, and, as I mentioned earlier, a lot of signs that the economy may be heading south soon, I was intrigued. So I read it. The reporter quoted a few investors who had been burned by short-sellers (they operate their own websites, which disclosed that fact even though the reporter did not). He never called the Securities and Exchange Commission to get its comments on the systemic risk posed by hedge fund activities. He never called the Federal Reserve, which closely monitors and regulates capital markets for systemic risk threats, about its analysis of the situation. In short, no real reporting.

It is often said that our democracy cannot survive without a free press. But when the only information the new economy's free press provides is ill- or uninformed opinion, what kind of democracy will we have?

Provenge -- Again

So much has been written about the experimental prostate cancer drug Provenge that I have hesitated until now from getting into the morass. It's a fascinating tale that involves conflicts of interests, Wall Street insider trading, serious questions about the drug's efficacy, and Washington lobbying. Note what I didn't put on that list: the science behind the drug.

Rather than add my own two cents, let me point you to a few places where you can read about it. First, though, let me give my bottom line: two influential oncologists raised legitimate questions about whether the limited clinical trials completed so far warranted fast approval for the drug. But because at least one of them was involved in running a late stage clinical trial for a rival therapeutic approach for prostate cancer, frustrated investors and some groups in the prostate cancer patient advocacy community raised howls of protest on internet bulletin boards and on Capitol Hill. There have even been anonymous death threats hurled at the two physicians, according to published reports.

But let's place the blame where it ought to be in this scientific fiasco. The FDA had no business appointing scientists testing a rival drug for another firm onto an advisory committee evaluating Provenge. Oncology is a field where the agency could easily find other clinicians willing to analyze these data who did not have conflicts of interest.

It doesn't matter if these scientists were right (and, based on my quick reading of the data, they had a good case). Eliminating conflicts of interest isn't about keeping industry shills off these committees. It's about making sure the process of evaluating new drugs and devices is FAIR. The FDA should eliminate these conflicts of interest so that everyone involved -- patients, doctors, companies, scientists, investors and the public -- believes the process has been fair and evenhanded, and the end result dictated by the science.

Unfortunately, at this hour, the conference committee considering FDA reform legislation is leaning against strict limits on conflicts of interest on FDA advisory committees. It appears that no matter many times the current system fails, Congress just can't get up the gumption to "just say no" to industry influence over this regulatory agency.

The earliest accounts of the Provenge saga appeared in The Cancer Letter, which is subscription only. Dr. Roy Poses on Health Care Renewal in June provided a good rundown on the press coverage. Today, Maggie Mahar offered her long take on the situation on the Century Foundation website. A shorter version ran on the Health Care blog. The latter is worth looking at since you can get a flavor for the Provenge proponent arguments by reading the comments that have poured in.

Escaping Taxes

From today's papers:

Tax Break Used by Drug Makers Failed to Add Jobs

Blackstone, Sugar Daddies, and a Sweet Deal

Half of Big Firms Fail to Pay Taxes

Reconsidering Corporate Tax Breaks

What do the first three stories have in common? They're all about how big companies and wealthy individuals escape paying taxes by shifting income -- from the U.S. to abroad; from one state to another; or into capital gains, which is taxed at a lower rate.

Yet in listening to the Democratic candidates debate last night, when the subject of taxes came up, most of the candidates emphasized repealing the Bush tax breaks -- not changing the laws passed with bipartisan support at both the national and state level that allow corporations and wealthy individuals to make income disappear entirely.

The last headline is a story about a new study from the Treasury Department suggesting repealing some tax breaks -- like the research and development tax credit -- would allow all companies to have lower rates. A few candidates last night made this point, and to their credit, said it was average individuals, not corporations, that should get the lower rates by repealing the Bush tax breaks, which were aimed at high-income individuals.

But I'm still waiting for a Democratic candidate to talk about taxing corporations fairly by eliminating loopholes that allow them to move income to lower tax countries or states. That has to be one of the largest grand larcenies in the tax code.

AMA, AARP in Lobbying Link-Up

Here's an interesting development. The American Association of Retired Persons and the American Medical Association have joined hands to support a House bill to expand the states' Children's Health Insurance Plan (S-CHIP). The strange bedfellows coalition was reported this morning by Robert Pear in the New York Times.

The article is clear on what the AMA gets out of the deal. The House bill, which covers more kids and even some uninsured adults who were not covered in legislation that cleared a Senate committee last week, also increases physician payments. Under current law, Medicare payments to doctors are scheduled to decline slightly next year.

But what's in it for the AARP? To its credit, the AARP has been willing to wield its lobbying clout on behalf of seniors' grandkids, not just seniors themselves. Enlisting the AMA in the cause is a real feather in its cap.

Moreover, the bill would raise some additional funds by cutting Medicare's excess payments to insurance companies that sell group plans (HMOs) to seniors. They're known as Medicare Advantage plans. The 2003 law that created the prescription drug benefit encouraged these plans by offering higher-than-average payments for every senior who enrolled. The goal of the architects of this approach is to undermine Medicare. They accomplish that by siphoning off its healthier beneficiaries into private insurance plans that are subsidized for taking on these lesser risks (for a good overview of the subject, see Saul Friedman's column in Saturday's Newsday). The insurance industry's pathetic defense of these scams is that it is offering greater benefits to these healthier seniors. Again, it's a coup for the AARP, which actually helps market some of these Medicare Advantage plans, to get the AMA on board in cutting Medicare advantage payments to insurance companies while defending the public program.

But don't look for the kumbaya moment to last long. Two weeks ago, William Novelli, chief executive officer of AARP, outlined his priorities for health insurance reform at a Center for American Progress briefing. One of Novelli's preferred approaches for "getting Medicare right" would increase the use of physician assistants and nurse practitioners to hold down health care costs. Such a move is adamantly opposed by organized medicine. Indeed, the AMA has made that provision its prime reason for opposing Gov. Ed Rendell's health insurance reform plan in Pennsylvania.

Meanwhile, President Bush is threatening to veto any expansion of S-CHIP, whether the Senate or House versions. For this extremist president, undermining any and all public programs far outweighs the needs of children.

Most Important Drug-Safety Legislation in a Century?

The New England Journal of Medicine in an editorial this morning calls the Food and Drug Administration bill now moving through Congress "the most important drug-safety legislation in a century." More important than the 1938 law that ushered in the safety requirement? More important than the 1962 law that required drugs be effective?

The editorial's list of the essential ingredients that must be included in a successful reform bill also did not justify the hyperbole:

While it called for mandatory public registration of clinical trials, it did not call for mandatory public posting of their results.

While it called for stiff penalties for false advertising, it did not call for a ban on direct-to-consumer ads, which are deeply resented by most members of the medical profession not to mention a significant contributor to the distortion of medical priorities in this country.

The editorial makes no mention of tougher standards for approving and monitoring medical devices. Remember the brouhaha over drug-coated stents? Millions of Americans with heart disease had them inserted, but sales are now collapsing because outcomes are worse than patients who received the bare-metal variety. Yet the provisions on devices in this bill are so weak that the industry's trade association has admitted they "dodged a bullet" and offered warm support for the bill.

And, finally, the editorial did not mention ending or even limiting conflicts of interest on FDA advisory committees, which is contained in the House version of the bill.

While the editorial refers favorably to last year's Institute of Medicine report, it ignores one of the central messages of that report: that the FDA's culture has become warped in favor of industry because of its reliance on industry user fees, in place since passage of the 1992 Prescription Drug User Fee Act. The agency is now primarily oriented toward approving new drugs, not protecting the public from unsafe or ineffective drugs.

Instead of altering those incentives, this bill increases the agency's reliance on user fees. More will go to safety compliance, for sure. But a truly significant FDA reform bill would have cut the ties between the user fees and agency performance goals, which all involve speeding new drugs to market. Or, it would have eliminated user fees entirely and appropriated taxpayer resources to fund this critical agency. Can't the government find another half billion dollars a year? Heck, that's what we spend in Iraq in two days.

The greatest reform in a century? This editorial sends a clear message to Capitol Hill on the eve of its conference committee that as far as the medical profession is concerned, milquetoast reforms are enough.

Summers on Health Care

Former Secretary of the Treasury Robert Rubin's Hamilton Project, housed at the Brookings Institution, held a forum at the National Press Club yesterday on health care reform. A first panel laid out four approaches, from expanding Medicare to include the uninsured to individual mandates tied to eliminating the tax deductibility of health insurance, which disproportionately helps upper income Americans in the same way the mortgage interest deduction does. (The more you earn, the higher your tax bracket, the more the value of a tax deduction.)

However, it was another erstwhile Treasury Secretary, sitting on the second panel with a CEO, a union leader and a former Bush administration official, who made the best comment of the morning. "When only 20 percent of Americans with hypertension get proper treatment," Lawrence Summers said, "framing the question as insuring the uninsured just isn't asking the right question."

The question for the panel was whether the next administration should pursue incremental reforms or a wholesale redrawing of the health care system. Summers, his self-deprecating wit enhanced by having been ousted from the presidency of Harvard, prefaced his remarks by saying "I'm not usually plagued by doubt, but I don't know where I come down."

He likened the current system to a board game where every player draws cards that send them to various places on the board where special interests game the system while patients and payers get arbitrary and variable outcomes and costs. He then said it will grow worse in the next few years because of personalized medicine, which will only allow insurers to predict with more certainty who will get sick in the future. In other words, adverse selection, where profit-maximizing insurers shrink their risk pool by eliminating those with pre-existing conditions, will grow.

Yet he concluded by saying it was hard to imagine comprehensive reform, such as a single-payer plan or even expanding Medicare, without some catastrophic event that deeply affected the 85 percent of the public that already has insurance. Like what? A major flu epidemic or a major economic downturn where business gets serious about health care's impact on its competitiveness, he suggested.

When the CEO of General Mills, Steven Sanger, suggested Congress could start by repealing the tax break for health insurance and redistribute the revenue to help low-income people buy individual health insurance, it was Summers who trenchantly destroyed the arguments behind the Bush administration proposal.
It would double the adverse selection by forcing millions of Americans into the dysfunctional individual health insurance market, he said, while encouraging healthier people to buy low-cost catastrophic plans that would further erode the pooling of risk that is essential to any successful health insurance system.

A decade ago, just before he became Treasury Secretary, I wrote a profile of Summers for Boston Magazine. I dutifully catalogued all the incidents that had earned him a reputation for being intellectually and personally arrogant. But the comment I recall most from our interview was his response to my question about his ambitions, and what motivated him to always want to be the best, whether on the tennis court, in a classroom, or in politics. "It's not ambition," he said. "I'm motivated by new challenges."

He's just a lowly Harvard professor now. His recent setbacks appear to have washed away most of the arrogance. Yesterday, he was witty, gracious and attentive to others' concerns -- skills one learns when wending one's way through the rat's nest of politics in academia and Washington, where special interests inevitably prevail.

It's easy to imagine him taking on some challenge for the next Democratic president. He's not a health care economist. But given the obvious attention he's given to the subject lately, perhaps he's auditioning for the role that Hillary Clinton played in the Democratic Party's last attempt to reform the health care system. Based on what I heard yesterday, he'd be a good man for the job.

FDA's Avandia Committee Riddled with Conflicted Docs

Bloomberg News yesterday ran a long story on the six conflict-of-interest waivers granted to members of the upcoming Food and Drug Administration advisory committee that will consider the cardiovascular risks associated with Avandia, GlaxoSmithKline's diabetest drug that was in the news yesterday when an Agency for Health Care Research and Quality study showed that generic metformin was better than pricier drugs like Avandia and Actos for lowering blood sugar levels. It's not just a cost question. Avandia's most prominent side effect is water retention and weight gain, which can lead to all kinds of complications for diabetics.

The blogosphere that covers the pharmaceutical industry jumped on the story, which prominently featured a quote from me (modesty prohibited me from blogging on it myself). So, if you want to read more, you can at Pharmagossip and Health Care Renewal.

Hospital Exec Touts Asthma Device, Silent on Hospital’s Role

Paul Levy, the chief executive officer of Harvard University-affiliated Beth Israel Deaconess Medical Center in Boston, last week used his popular blog to tout a new device for treating severe asthma that he found "fascinating." It should stir up interest in the device since Levy's blog, called Running a Hospital, is ranked 13th among the world's top blogs in health and medicine, according to EDrugSearch.com.

Levy called the invasive procedure, which involves using a catheter-controlled device to deliver heat to reduce internal muscle swelling in blocked air passageways, a "huge development in the treatment of this very pervasive disease. . . If it works as presented," he said, "this would be one of those medical developments that actually offers a reduction in the cost of health care."

The device is still in clinical trials so data to support Levy’s statements isn’t available. The blog item also hid Beth Israel Deaconess’ role in the procedure's development. A link took Levy’s readers to the website of the device's manufacturer, Asthmatx of Mountain View, CA, which is sponsoring the clinical trial. The Asthmatx website contained a page listing the 32 clinical trial sites on five continents, including arch-rival Brigham and Women's Hospital in Boston. Neither Levy's blog nor the Asthmatx website revealed that Beth Israel Deaconess was also one of those sites, having announced its role a year ago in a press release. The hospital is also listed as a trial site in the government's clinical trials registry. Levy also failed to mention that his hospital has had a consulting contract with Asthmatx or its predecessor company at least since 2001, according to documents filed last year with the Securities and Exchange Commission.

Most medical journals have long required that physicians conducting clinical trials for the private sector reveal those conflicts of interest when publishing studies. Newspapers and electronic journalists in recent years have followed suit when reporting on medical advances. But the blogosphere operates without rules, even when the blogger runs one of the nation's leading teaching hospitals.

Why Not Farm/Factory of Origin Labeling?

China's decision to limit imports of some U.S. meat products has triggered fears that consumer safety concerns will become the new focus of trade disputes (see this morning's Wall Street Journal). That's the good news. If tit-for-tat retaliation increases cleanliness and inspections in both nation's food production facilities, everyone gains.

But a broad brush ban on a class of consumables -- such as all U.S. poultry products or all Chinese-made toothpaste -- is a blunt weapon. It's unfair to producers who follow the rules and maintain first class factories. That's why country-of-origin labeling for food products, touted last week in editorials, is no solution. That may appeal to consumers' prejudices, but it hardly gives them actionable information. That Chinese toothpaste was bad, so all Chinese toothpaste is bad?

A better solution is farm- or factory-of-origin labeling (which, of course, would include country-of-origin labeling). This will give public health officials and inspectors instantaneous feedback about the source of a problem once it has been identified, and will enable them to shut down that source without the collateral damage of economically harming other producers who follow the rules and make safe products.

If free traders are really worried that consumer safety concerns may be used as a new weapon in the never-ending international trade wars, the solution is raising the regulatory bar, not lowering it.

Is Waiting on Line Good for Your Health?

Waiting on line for medical services is the horror-filled future conjured up by opponents of a single-payer health insurance system. Look at Canada. Look at Great Britain, the opponents warn.

But what if those lines actually improve health care outcomes? What if they are one reason why citizens of those countries live longer lives than their American counterparts?

Those thoughts come to mind after reading a commentary on cost-effectiveness analysis in the latest Journal of the American Medical Association (subscription required). Cost-effectiveness analysis is an economists' tool for judging the value of a good or service in markets where pricing signals are inoperative (health care, underwritten by third party payers who stand between the providers and consumers, is a classic case). Written by two Canadian physician/economists, the commentary points point out how most efforts to rationalize health care expenditures via cost-benefit analysis are fatally flawed because they use use that tool in isolation from other considerations.

Most cost-effectiveness analyses rely on a measure called the quality-adjusted life year. A QALY for a given therapy is determined by placing a value on a medical therapy’s clinically-proven outcomes that has been adjusted for how much surveyed patients think it is worth in terms of living longer, reduced pain, greater mobility and other quality variables. Those quality-adjusted outcomes, measured in increased years of life per patient treated, are then divided into the cost of treating a patient. It yields a QALY ratio for that particular therapeutic approach.

In the U.S., paying organizations like insurance companies use QALY ratios to determine whether they’ll pay for a new technology (Medicare by law is prohibited from using this tool; it uses a “reasonable and necessary” standard when making coverage decisions). But, in most cases, insurers use an arbitrary benchmark such as “we’ll pay for anything under $20,000 per QALY.” That’s not true cost-effectiveness analysis, Allan Detsky and Andreas Laupacis of the University of Toronto argue.

Using cost-effectiveness ratios in this way may lead to inappropriate decisions, because funding may not be provided for therapies that have more economically attractive ratios but have not been considered when the decision maker looks at 1 program in isolation. Simply adding all programs with known ratios below a threshold will inevitably lead to a never-ending increase in the health care budget, because very few new therapies are cost-saving or cost-neutral. In addition, one speculation is that the identification of an arbitrary economically attractive or "cost-effective" ratio may have the effect of encouraging drug companies to charge a price that achieves that ratio, even if they could make a profit at a lower price.

True cost-effectiveness analysis, they argue, compares the cost benefit of a therapeutic approach to other approaches for the same medical problem. Or, a centralized payer on a fixed budget (a government agency or an insurance company that wants to hold rates steady while continuing to make a profit) uses the information to maximize the health care gains for a certain level of expenditures. Using $1 million to give 50 seniors artificial hips may help those 50 people get around better, but that’s less effective than using the money to administer 200,000 seniors flu shots, which would probably save more than that number of lives.

In countries on fixed budgets like Canada and Great Britain, medical payment authorities are forced to make such comparisons and ration care accordingly. The result is that their physicians are more likely to deliver care that most people really need while skimping on expensive and marginally effective treatments. Yes, people wait on line for those latter treatments, but they can take comfort in the fact that it is the price for ensuring that their fellow citizens get needed care on a timely basis.

The way the QALY tool is used in the U.S., on the other hand, incentivizes providers to increase the use of marginally effective services whose prices have been inflated to the arbitrary payment threshold. Meanwhile, less costly but highly effective treatments get ignored. In practical terms, we get a lot more orthopedic surgeons making a half million bucks a year replacing a couple of hips a day, while there’s a shortage of primary care docs willing to make the rounds of nursing homes immunizing seniors.

From a public health standpoint, that's not cost-effective medicine. And it may be one reason why on average we live shorter lives in the U.S. than those line-sitting Canadians and Brits.

CMS Will Pay for Comparative Trials

At least, that's the way I read this coverage decision memo, published yesterday by the Center for Medicare and Medicaid Services. CMS officials didn't return a phone call or email seeking comment.

The immediate winner should be an NIH-funded trial comparing two biotech drugs, both made by Genentech, that are used for macular degeneration in seniors: Lucentis and Avastin. The former costs $1,000 a shot; the latter $40 a shot, even though they do the same thing. For more background on why the could wind up saving taxpayers hundreds of millions, see the GoozNews posts here and here.

Rendell's Health Care Plan

Among the presidential candidates, Gov. Bill Richardson of New Mexico is one of the few that has so far categorically ruled out tax increases as part of his path to universal health care insurance. His plan: cut costs and use the savings to get everyone into the system.

State officials have a pretty good sense of what it takes to get something done in a capital. The lobbying forces that weigh in at the state level are the same ones that weigh in at the national level. Learning how to confront, manipulate and compromise with those forces is central to the job description of a president who is going to get things done.

One of the major choices voters have next year is whether they want an "outsider" from one of the nation's statehouses -- don't forget that four of the last five presidents were former governors -- or a Washington insider who is inevitably compromised by long-standing ties to major lobbying organizations in the nation's capital. If you choose the former, then Richardson becomes a logical choice. Given his international experience (he's negotiated with many of the belligerants on earth), energy expertise and the fact that he's Hispanic (the other "first ever [blank] elected president!] in this race), it's rather surprising that the nation's press hasn't given his dark horse candidacy more attention.

That said, his approach to health care is the tough road. Kevin Sack's excellent article in today's New York Times on Gov. Ed Rendell's efforts to enact universal health care in Pennsylvania shows why. An experienced local (former mayor of Philadelphia) and state politician, he is trying to get everyone covered by asking all the special interests in the system -- the insurance companies, the doctors, the hospitals, the small businesses who don't provide coverage for their employees -- to give up a little economic ground. Not surprisingly, he's run into a buzzsaw of opposition. Here's the relevant paragraphs:

Hospitals are lobbying against his proposals to regulate expenditures for new construction and equipment and to cut off reimbursement payments when patient stays are extended because of medical mistakes and preventable infections. Doctors do not like his proposal to give more responsibility to physicians’ assistants and nurse midwives.

Small-business owners are protesting his call for a “fair share assessment” — a 3 percent payroll tax on employers who do not offer insurance, with the proceeds dedicated to covering the uninsured. And insurers are working to defeat proposals that would prohibit consideration of preexisting medical conditions in rate-setting and require that at least 85 percent of premiums be spent on health care costs as opposed to administrative overhead.

In the wake of actions by Massachusetts and California to enact universal health care plans, Rendell thought his proposal would be a slam dunk. He now gives it no better than a 50-50 chance of success. The denouement of this struggle bears watching. More than the other large states that have passed deeply flawed universal health care plans, it has brought the major lobbying forces into play because it curbs some of their power -- something any successful plan will have to do.

If Rendell wins, it will raise the stakes in the health care debate that will dominate next year's presidential race. And it will improve the chances of the governors in both party's races who argue that they're the ones that know how to get things done in a capital.

FDA Issues Three Waivers for Back Device Panel

If anyone needed additional reasons for backing the conflict-of-interest limitation in the Food and Drug Administration reform bill that will be voted on in the House later this week, the latest advisory committee roster published on the FDA website provides plenty of fodder. The agency gave a conflict of interest pass to three physicians who will be serving on the Orthopedic and Rehabilitation Devices Advisory Panel that meets July 17. The panel will consider Medtronic’s application to approve a prosthetic spinal disc for the reduction of back pain in older adults.

The physicians voting on the device will include the University of Alabama’s John Kirkpatrick, who owns stock in Zimmer Corporation and Johnson and Johnson, two leading Medtronic competitors. According to FDA documents, Kirkpatrick’s holdings are each valued between $15,000 and $25,000. Panelist Stuart Goodman of Stanford University authored a study funded by Stryker, which manufactures a bone growth supplement. He also has recently received between $10,000 and $50,000 in consulting fees from Medtronic competitors, according to the FDA. Finally, Edward Hanley owns Medtronic stock valued between $25,000 and $50,000.

More significantly, Hanley's employer, the Carolinas Medical Center, was involved in testing the Medtronic prosthetic disc that will be before the advisory committee, according to the FDA. In other words, his employer's other employees tested the device that he will be judging.

Hmmm, let's think about that last one for a minute. His employer and his colleagues say yes. Will he have the courage to say no? And if the evidence is overwhelming and he says yes, why should we, the public, believe him? The FDA has put the poor man in an impossible situation. They ought to do him a favor and throw him off the committee. And the House should pass the one waiver-per-committee limit, and push hard for including it in the final bill when its conferees sit down with their Senate colleagues later this summer.

Did CMS Overreach on EPO?

This hasn’t been a good year for Amgen or Johnson & Johnson, which make various forms of EPO, the biotech wonder drug that raises red blood cell counts (as every dope-taking Tour de France bicyclist knows). Clinical trials have shown that they can increase the risk of heart attacks and strokes in dialysis patients, whose failing kidneys don’t produce enough natural erythropoietin; and, they hasten death for some cancer patients with solid tumors when the drugs are excessively used to alleviate chemotherapy-related anemia.

The Food and Drug Administration in May determined that the “dear doctor” letters sent out by the companies in January didn’t go far enough. It slapped a black box warning on the drugs, which are sold under the Aranesp, Epogen and Procrit labels. The agency also convened an oncologic drugs advisory committee meeting where one attending physician, after reviewing the evidence, expressed concern that the drugs might be “Miracle-Gro for cancer.”

In mid-May, the Center for Medicare and Medicaid Services (CMS), which foots the tab for most EPO use (dialysis is paid for by Medicare and most cancer patients are over 65), decided to scale back its payments when the drugs are used for cancer. While the policy was announced shortly after the FDA advisory committee meeting, it had been in the works for nearly a year and was accompanied by an exhaustive review of the medical literature, notable for its lack of completed trials. Still, the evidence suggested:

Emerging data suggest that ESA use may be associated with increased morbidity and mortality in a variety of patient populations despite the alleviation of anemia. Although the features and exact mechanisms of the increased mortality require better delineation, both thrombo-embolic-vascular disease and tumor progression appear to be involved.

It didn’t take long for the EPO empire to strike back.

This week, Senators Kent Conrad (D-SD) and Thad Cochran (R-MS) circulated a letter on Capitol Hill for other senators to sign. It clearly echoed talking points written by Amgen and J&J lobbyists in urging CMS to “carefully consider the public health consequences of this proposed coverage decision.” The letter warned that the CMS proposal will raise demand for transfusions from the nation’s limited blood supply and negatively affect the quality of life of the nation’s cancer patients.

The emerging data that these drugs when used off-label were probably killing people didn’t get mentioned in the letter. Indeed, the fact that EPO use in cancer patients is largely off-label and may be “inappropriate” doesn’t appear until the fifth paragraph of the senators’ 7-paragraph letter, and even then it is raised as part of these senators’ admonition to CMS’s leaders that the agency’s safety concerns should not be used to limit patients’ access to “appropriate care.”

The senators are not alone. Similar letters have been sent to CMS by the American Society of Clinical Oncologists and the Community Oncology Alliance, whose members earn large profits from infusing patients with EPO in their offices, a system that a New York Times editorial appropriately labeled a kickback scheme. Company discounts are based on how much EPO doctors use (see this GoozNews, which commented on an early May New York Times story documenting the system).

The details of the CMS decision are complex, but reduced to their essence, the agency fears raising red blood cell counts too soon, too quickly and to near normal levels does more harm than good. When the new rule goes into effect, CMS will not reimburse physicians for EPO use in cancer patients with solid tumors unless their hemoglobin level falls below 9 grams per deciliter of blood (a hematocrit of 27). It will also limit treatment to 12 weeks per year and eliminate EPO use for certain conditions, including vitamin deficiency, radiation-induced anemia and when patients have uncontrolled hypertension.

The agency also wants to eliminate its use in myelodysplasia, a form of leukemia. That suggestion drew heated protests from the patient community that suffers from the disease and the doctors who treat them. There is evidence in the literature that they benefit from EPO use because of their need for frequent transfusions. Not surprisingly, the senators and oncology groups emphasized that condition in their letters.

The CMS draft decision memo probably needs some adjustments. Perhaps myelodysplasia should be taken off the list. Perhaps the cap on weeks of treatment should be related to the number of times a person gets chemo during the year, since that varies from cancer to cancer.

But the last thing CMS needs is pressure from Capitol Hill to roll back the larger intent of the proposed payment policy. What the agency needs instead is legislative support for its efforts to help doctors obey the initial injunction of all medical practice – “First, do no harm.”

The evidence is rapidly mounting that the hypermarketing of these drugs by Amgen and J&J, aided and abetted by CMS payment policy, encouraged oncologists to disobey that cardinal rule. It needs to end now, and the best way to do that is by cutting off the mother's milk of medical misfeasance: payments for inappropriate use.

Brazil Gets a Better Deal

When I was visiting Brazil in early May, that country was enmeshed in touchy negotiations with Abbott Labs over the price of one of its more important AIDS drugs -- Kaletra. Brazil was threatening to issue a compulsory license that would enable it to begin generic manufacturing unless Abbott lowered the price. The Wall Street Journal went into high dudgeon mode, railing against countries that rip off the intellectual property of U.S.-based multinational drug companies. Given the uproar, I went out of my way to visit with a local economist/politician, who said the threatened compulsory license was nothing more than a negotiating tactic on the part of the Lula da Silva administration.

Today's news confirms his view: Reuters is reporting that Abbott Labs has agreed to lower the price of Kaletra by nearly 30 percent for Brazil. If it works for Brazil, why not Medicare, which was specifically forbidden by the 2003 Medicare Modernization Act from negotiating lower drug prices on behalf of U.S. seniors -- and the taxpayers.

Why Not Safe Food?

The New York Times today editorializes in favor of country of origin food labeling, which has been defeated during the Bush years by industry lobbyists. With an increasing share of U.S. food coming from abroad and safety scares multiplying, labels informing consumers where those shrimp, steaks and veggies that they'll be throwing on the grill this afternoon seems like a no brainer.

Yet I wonder. What am I as a consumer supposed to do with this information? Tell me if the fish is farm-raised or wild caught. Tell me if the vegetables are grown organically or through heavy use of herbicides and pesticides. But do I really care where food comes from as long as it is safe?

This is another case where the power of industry has forced consumer advocates to seek a weak half-measure. Disclosure through labeling has been substituted for the real solution to the food safety problem, which is more Agriculture Department and Food and Drug Administration inspectors.

We need more cops on the beat to police our entire food supply, whether domestically produced or imported. Country of origin labeling does nothing more than allow consumers to substitute their own prejudices for meaningful enforcement. That's no protection at all.

WARF Stem Cell Patent Under Fire

The Wisconsin Alumni Research Foundation financial claims on rival stem cell researchers took another hit earlier this week when some of the nation's leading stem cell scientists filed petitions supporting the Patent and Trademark Office's decision to rescind James Thomson's seminal patent on embryonic stem cells. The California-based Foundation for Taxpayer and Consumer Rights and Public Patent Foundation organized the scientists to file comments supporting the PTO's action.

For background on the scientific significance of breaking down the patent barriers in the emerging stem cell field, see my article in PLoS Medicine here.

The most interesting brief came from Douglas Melton of Harvard University, one of the nation's leading stem cell scientists. He wrote:

I very much believe that Dr. Thomson deserves the scientific and public recognition he has received. However, he deserves that recognition because he undertook the arduous and timely task of getting fresh and high quality human embryos to use as starting material in his work, and sufficient funding for such research, not because he did anything that was inventive. It was access to those resources, which were, and to this day still are, very difficult to obtain, that enabled Dr. Thomson to achieve his accomplishment. His perseverance and commitment deserve recognition and accolades. But I believe that had any other stem cell scientist been given the same starting material and financial support, they could have made the same accomplishment, because the science required to isolate and maintain human embryonic stem cells was obvious.

As every patent attorney knows, a new invention must meet the test of being "not obvious." Melton points out in his comment that anyone with adequate funding could have used readily available technologies to isolate embryonic stem cells. It was only Thomson's access to funding from Geron Corp. that allowed him to claim the mantle of being first. But being first isn't what defines an invention. That requires doing something no one else has ever thought of. The WARF patent, Melton said, fails that test.

EPA Shorts Public on Disclosure

What is an acceptable level for clean air, clean water or toxic cleanups, which are required by the nation's environmental laws? To make those determinations, the Environmental Protection Agency must first determine what level of pollution harms public health, and then make a policy decision as to what level of protection is technically feasible. In theory, the cost of protection isn't supposed to enter into the equation, although as a practical matter it always does.

Weighing the science is key as researchers learn new facts about the relationship between various pollutants and disease. With the nation's children in the grip of a growing asthma epidemic, it should come as no surprise that researchers are finding new evidence that air pollution is a major culprit.

Last week, the EPA announced the candidates for a new outside advisory panel to help the agency sift through this evolving scientific landscape. This subcommittee of the Clean Air Scientific Advisory Committee will make recommendations as to what level of particulate matter -- fine particles of soot -- is acceptable. The EPA has a fairly open process for setting up its advisory committees. It first invites the public to submit nominations. It then publishes a "short list" of candidates and invites public comment on their credentials. And, finally, it publishes its final roster before it gets down to work.

Sounds fair, right? But what good is a transparent process if the information the EPA discloses to the public about the nominees falls short of full disclosure? How can the public, which includes the interested community of fellow scientists, environmental activists and affected industries, comment intelligently on a list of candidates that does not include key elements of their biographies?

For instance, the EPA's short list for the particulate matter panel contained 55 experts, most with sterling biographies outlining long lists of published studies for various government agencies and non-profit institutes. Take Robert Phalen, the University of California at Irvine Professor of Community and Environmental Medicine, for instance. He's conducted research in the field for over 30 years, we're assured. He's received grants from various government agencies and foundations.

What we're not told is that he has also written a book questioning the link between particulate air pollution and adverse health effects and arguing that tighter air pollution standards are premature. His short bio also ignores the fact, disclosed in that book, that he received research funding from the Southern California Edison Company and the Electric Power Research Institute (EPRI), the research arm of the utility industry.

Another example: the short biographical sketch about Peter Valberg mentions that he is an employee of Gradient Corporation, a private consulting firm. But it doesn't disclose that his clients include Carbon Black Manufacturers and an undisclosed mining company, and that he has penned critiques of EPA findings on health risks of air pollution for the Engine Manufacturers Association.

These are flagrant conflicts of interests that, by law, should exclude them from participating on this advisory panel. No doubt environmental groups will criticize these and many other scientists on the short list during the public comment period. But without publishing the full bios of its proposed candidates, the EPA has denied the public what it needs to make informed comment. In this case, partial disclosure is worse than no disclosure at all.

The Contrived Search for a Middle Way

I must be getting lazy. It's Monday morning, and I'm still thinking about the Sunday papers. Or maybe it is the contrived nature of what my hometown paper (I live in Washington, DC, the new Rome, according to all the book reviews) considers news.

Yesterday's Washington Post all but endorses a third party "independent" bid for the presidency. Between a less than insightful polling story on the many faces of self-identified independent voters and a David Broder column outlining the political space a potential independent candidate could occupy, the paper clearly identifies with what is rapidly emerging as the inside the Beltway consensus: all the announced candidates are pygmies.

What's needed now, these grand poobahs of conventional wisdom assure us, is a candidate who can occupy political real estate that is more precious than a vacant lot on Massachusetts Avenue's embassy row -- the above-it-all center. Too bad Michael Bloomberg and Arnold Schwarzenegger, who recently graced the cover of Time Magazine, are, respectively, a short, Jewish media mogul from ultra-liberal New York and a naturalized citizen from the Left Coast.

They are the archetypes for what is likely to be a major distraction in next year's presidential campaign: the problem-solving man of the middle whose primary appeal is to self-satisfied middle class voters for whom a pox on both your houses is always the preferred non-ideological stance. Never mind that such a candidate stands no chance of getting elected, or, if a freak accident happened and they actually got into the White House, of solving any of the serious problems facing this country (number one in foreign affairs: disengaging from Iraq; number one in domestic affairs: universal health care).

The real purpose of such a candidacy is to deny the winning Democratic candidate a mandate, which is as of this writing the most likely denouement of the gross failures of the Bush administration, the worst in modern American history.

In that regard, my best reading over the weekend was former American Prospect editor Michael Tomasky's review of two new books on Hillary Clinton: Carl Bernstein's "A Woman in Charge" and Jeff Gerth and Don Van Natta Jr.'s "Her Way." He's no fan of Clinton. Tomasky has written his own critique of her campaign for the Senate.

But he puts these latest journalistic rehashes, now flying off bookshelves across the country, in their proper context, which also applies to the misconceived search for an independent candidate who could only subtract from the emerging national consensus that a Bush repudiation is in order for 2008. He writes:

(These authors) want to relive the controversies of the Clinton White House. After an unprovoked war built on lies, the deaths of tens and possibly hundreds of thousands of Iraqi civilians, illegal domestic spying, government-sanctioned torture, the indefinite incarceration of suspects, a scandal surrounding efforts by the nation's highest-ranking law enforcement officer to install prosecutors willing to undertake blatantly political prosecutions, and astonishing tales of congressional corruption, is it not at least demeaning and superfluous to be presented with one-thousand-plus pages revisiting such questions as how many hours of billable work Hillary Clinton actually performed for Madison Guaranty? It might not be, if we learned useful new information, about both the Clinton presidency and Hillary's more recent record in the Senate. But "Woman in Charge" and "Her Way" — the former sometimes by intent, the latter almost always inadvertently — tell us less about Mrs. Clinton than they do about the political and journalistic cultures that allowed hysteria about the Clintons to thrive.

Or drumbeats for independent candidates to sound.