Value for Money

The New England Journal of Medicine article that got the widest pickup today in the MSM (main stream media) was Harvard University professor David Cutler's study suggesting the U.S. health care system, despite its skyrocketing costs, provided a reasonable return on investment over the past 40 years.

For those who may not have seen the news reports, the study pointed out that life expectancy has risen from about 70 to about 78 over that period. He attributed half the increase to improved medical technologies, and half to other factors (improved diet, less smoking, etc). Then, looking at the amount we spend on health care, he suggested that the cost of health care for each additional year of life fell well below $100,000. That, he concluded, makes our off-the-charts health care spending a decent buy.

No quarrels with the data. But how about all those other industrialized countries around the world that have increased their life expectancies by an equal or greater amount (most, by the way, are greater)? What would he say about their state-run health care systems, which generally cost about half to 60 percent of what the U.S. spends?

As Jack Benny used to say: What a bahgin!

Celebrex Strikes Out

There’s some disturbing news for Pfizer in the latest edition of the New England Journal of Medicine. Two company-funded clinical trials that tested Celebrex’s ability to prevent the recurrence of colon polyps showed the drug doubled the risk of heart attacks and stroke compared to people who took aspirin for the same purpose.

While that’s not as bad as Vioxx, which quadrupled the heart attack risk compared to people taking another pain pill (naproxen in that case), it’s still a pretty strong signal that this drug has no place in most persons' medicine chests.

The trials accomplished what they set out to do: they lowered the chance that people who have had colon polyps removed after routine colonoscopies would have a recurrence of the growths, which are often benign. But the ultimate benefits – which is colon cancer prevention – were relatively minor: if a thousand persons took the drug for three years, 1.5 persons on Celebrex would get cancer compared to 3.1 persons who took no drug at all. But a thousand persons taking low-dose aspirin would get almost exactly the same benefit – just 1.9 would get colon cancer.

But what would happen on the “cardiovascular events” side of the ledger for these thousand-person groups? The thousand-person group taking no drug at all would suffer 17.7 heart attacks and strokes, according to the data in the trials. The Celebrex group, meanwhile, would suffer 28.8 events and the low-dose aspirin group would experience only 12.1 events. One obvious conclusion from this trial is that low-dose aspirin is still one of the most effective tools we have for reducing one’s risk of cardiovascular disease, and we now know it is also somewhat effective at reducing the recurrence of colon polyps.

In an accompanying editorial to the studies (from which the above numbers were drawn), University of Washington professors Bruce Psaty and John Potter concluded that “celecoxib (Celebrex) has no role as a chemopreventive agent either in patients with nonfamilial colonic adenomas or in the general population.”

I suspect some cardiologists may take an even harder line, perhaps even calling for Celebrex’ removal from the market. Let’s hope we hear what they have to say in the morning papers.

Single-Payer Plan Advances in California

The Left Coast let out a roar yesterday that managed to escape the attention of the national media.

The Democratic-controlled California Assembly passed a single-payer health care bill by a 45-33 margin. The “Health Care for All Californians Act” would scrap corporate-sponsored insurance plans, Medicare and Medi-
Cal (the state’s Medicaid program) and cover everyone under a single plan. Insurance companies could sell policies to individuals and/or firms if they wanted coverage over-and-above the statewide plan.

The bill had already passed the Senate last May, also in a party-line vote. The core financing of the plan rests on an expanded payroll tax. Employers who provide health care insurance would be relieved of nearly $50 billion in annual premiums for workers and their retirees. All employers would instead pay an expanded 8.17 payroll tax, which would raise about $56 billion, according to a Lewin Group analysis of the bill conducted last year.

Individuals would be relieved of all deductibles and co-payments under the program, which would provide coverage for medically appropriate hospital inpatient and outpatient care, emergency room visits, physicians services (including preventive care), prescription drugs, lab tests, mental and substance abuse treatment, eyeglasses and dental services, and home health and adult daycare for the aged and infirm. In exchange, workers would pay a 3.78 percent payroll tax (on top of their current Social Security and Medicare payroll deductions).

In its analysis, the Lewin Group estimated that the total health care spending would actually decline by about 4 percent despite providing more extensive services for the nearly 5 million Californians without health insurance. “An increase in health services utilization . . . would be more than offset by savings due to administrative simplifications and bulk purchasing of prescription drugs and medical equipment,” the report said.

The Politics of Plan B

Let me see if I have this right.

President Bush at his Tuesday press conference says he will allow adults to purchase morning-after contraception pills over-the-counter.

On Wednesday, acting Food and Drug Administration director Andrew von Eschenbach releases a memo to staff (leaked to the Washington Post) outlining the agency's reasoning for limiting access to those over 18.

The FDA then announces today that its three-year review of Barr Pharmaceuticals' application is finally over and approves limited over-the-counter access (no gas stations or convenient stores, no one under 18) to Plan B. In an unusual move, the top official of the Center for Drug Evaluation and Research, Steven Galson, signs the order.

Do they expect us to believe this decision was based on science, after going to the White House to ask permission to make this decision? Do they do that for other drug applications, or just the ones that offend the religious right?

The American Taliban may be fulminating because the FDA allowed this form of birth control. But that's not the real story here. The long saga behind Plan B shows how FDA's independence and reputation as a science-based agency has been thoroughly undermined by this administration. That's not just bad news for sexually active teenagers. That's bad news for every American.

The Debate Heats Up: The Case for Single-Payer

Allow me this morning to steer you in the direction of two writers who don’t need any help from me – Malcolm Gladwell of the New Yorker and Katrina Vanden Heuvel of The Nation. Both in their latest writings laid out the argument for universal health insurance through a single-payer plan, Gladwell in the most recent issue of that magazine, and vanden Heuvel on her blog. I especially call your attention to her analysis of the flaws in the recently-enacted Massachusetts plan, which mandates that individuals buy insurance. She also highlights the vote in the California legislature this week on a state-wide single-payer plan, an exciting development. States have always been the laboratories of democracy, and if we're going to get true health reform in the U.S., some major states are going to have to take the lead. And a "tipping point" of my hat to Gladwell for resuscitating the legacy of Walter Reuther, truly a man ahead of his time on this, as on many issues.

Why Today's JAMA Editorial Doesn't Go Far Enough

The Journal of the American Medical Association has been making news lately, and not always for its publication of pathbreaking medical studies. After learning from readers about several incidents of failures by authors to disclose conflicts of interest, editor-in-chief Catherine DeAngelis tightened the journals disclosure rules and asked deans at the offending researchers’ institutions – including the famed Mayo Clinic College of Medicine – to beef up their ethics training.

Conflict-of-interest disclosure isn’t the only area where the editors at JAMA have felt compelled to tighten their oversight of researchers who work for for-profit firms. The editors also now require industry-funded studies to hire an independent outside data analyst to give its peer reviewers an extra layer of comfort with the presentation of information contained in articles submitted for publication.

In today’s issue of JAMA, Dr. DeAngelis offered a sober editorial summing up and defending her responses to the past year’s events (it was published online while I was on vacation). The “The Influence of Money on Medical Science,” contains some fascinating new revelations. Without naming names, she reported that some companies are insisting that their academic researchers avoid submitting studies to JAMA because of the rules requiring independent data analysis. One set of authors even withdrew their study and submitted it to another (unnamed) journal, which promptly published it and won “much media coverage” for its contents.

I’d like to know what study that was and where it appeared. Did those media reports reveal that it had been withdrawn from JAMA because its authors did not want to submit its data to independent analysis? Alas, she did not say.

DeAngelis also revealed that the dean of the Harvard Medical School, Joseph B. Martin, has informed her that he will send the 8,000 faculty members at that prestigious institution copies of JAMA’s new disclosure rules, as well as those from the New England Journal of Medicine. The three incidents of failures to disclose conflicts of interest to JAMA that made national headlines this year all involved HMS faculty.

But the editorial stopped short of breaking new ground. She once again rejected advice I offered two years ago, when a study I conducted for the Center for Science in the Public Interest pointed out that JAMA, like the three other journals studied, had a small but persistent pattern of authors failing to disclose their financial ties to firms with a stake in the outcome of the studies being published. That study recommended that journal editors ban authors from publishing for at least three years when such incidents are brought to their attention, as they often are, by readers. Here’s her latest response:

Leveling sanctions against an author who fails to disclose financial interests by banning publication of his or her articles for some time period would only encourage that author to send his or her articles to another journal; it cleans our house by messing others. So what about all editors, or at least a group, such as the International Committee of Medical Journal Editors, agreeing to share the information and jointly to ban the offending authors? Those who suggest this approach have not considered the risk of an antitrust suit.

This antitrust argument repeats comments she made to a reporter a few weeks ago. It's a red herring. I wrote a letter to the Times, which they chose not to publish. Here’s the argument.

If full disclosure of potential conflicts of interest is crucial to “ensuring that physicians and patients can properly interpret and more important trust, what they read” in journals, then isn’t failure to disclose conflicts of interest a form of scientific fraud? And don’t editors have a right to collectively protect themselves against fraud?

She says that getting academic deans to “intervene” with mandatory ethics training is a more effective method of sensitizing industry-paid researchers to their ethical responsibilities than sanctions that might violate some lawyer’s notion of antitrust law. If newspaper editors had the same attitude, then Jayson Blair would still be working – after his mandatory ethics training, of course.

Water, Water Everywhere . . .

I witnessed one aspect of the global water crisis two weeks ago during a stroll through the central market in Mae Sot, a small trading town on the Thailand-Myanmar border. To my surprise, peasant farmers were selling stacks of yellow corn, a quintessential new world crop. Their stands were right next to stalls carrying frogs, turtles and snakes. My 13-year-old daughter couldn’t understand how people could eat their pets. I couldn’t understand the corn.

A few hours later, as we drove past the rice fields south of the town heading toward a scheduled rendezvous at a malaria clinic on the Moei River, I got my answer. Over one rise, the paddies gave way to rolling hills of corn. Their golden tassles atop ten-foot stalks indicated the ears were nearly ready for harvest.

My physician guide, Francois Nosten of the Shoklo Malaria Research Unit, explained that growing water shortages in the region were forcing farmers away from their traditional rice crop, which is about as thirsty a staple as exists on earth. The problem in switching to the less water-intensive corn, he said, was that it made the farmers dependent on U.S. multinationals for their seeds since the hybrids sold in Asia, as in the U.S., are sterile. “It’s a form of dependency,” he said, “and not everyone appreciates that.”

It wasn’t my only run-in with the water issue during my trip. While in China, reports in the controlled press from Chungqing, a city of 31 million souls, were scary enough to make me begin hoarding the potable water that had been provided in my hotel room (you’d have to be out of your mind to drink what came out of the tap). Southwestern China had gone 70 straight days without rain – even as the southeast coast was being flooded by a monsoon. According to the press accounts, fields were in ruins, wells were running dry and thousands of people were being forced to flee their homes in search of water.

Naturally, this experience sensitized me to a new report out today (my first day back) from the International Water Management Institute, which is based in Colombo, Sri Lanka. The report saw many disturbing trends in the outlook for global water supplies over the next 50 years, but also held out hope for a world that will increase in population by 33 percent over that period.

The great pressure on global water supplies will come from agriculture, which consumes nearly 80 percent of all water. It takes anywhere from 400 to 5,000 liters of water to produce one kilo (2.2 pounds) of grain. But it takes 10,000 liters to produce a kilo of meat. With global wealth rising, each one of us is using more and more water, primarily through the food we eat. The average person’s caloric intake increased from 2,250 kcal per day in 1961 to 2,800 kcal in 2000 (South Asia and Sub-Saharan Africa are exceptions to this broad improvement). The prospect is that billions more people will be entering this meat-eating class in the next half century.

To cope, agricultural productivity will have to continue to rise dramatically. Output per acre doubled in the past four decades. The good news is that agriculture accomplished this goal without a commensurate increase in water consumption. Can agricultural and water productivity continue its rapid ascent?

The report was not sanguine. Many river basins around the world are overcommitted and, in some cases, no longer reach the sea. Water tables in China, India and Mexico are declining sharply in their most populated areas and are in danger of becoming exhausted. Water quality is being degraded by soil erosion, pollution, salinization, nutrient depletion and the intrusion of seawater, the report said.

Meanwhile, irrigation in developing countries is expanding rapidly. That increases agricultural production, alleviates poverty and facilitates industrialization by freeing up agricultural labor. But it simultaneously increases environmental degradation. Industrialization, itself a water-intensive process, puts additional strains on water supplies.

And all of this will take place in the context of global climate change where temperatures are rising and precipitation falling. Agriculture near the equator, where countries are usually poor, will be the first affected, the report points out.

The report offered no real solutions beyond “better governance.” What more could they say? Declining water resources, like global warming, is one of those mega-issues of the 21st century. It will shape human history. Governments and people will deal with it because they have to, and probably not a moment sooner. But as Asian rice farmers growing corn show, entire cultures can be transformed - and damn fast, too - when they are hammered by larger-than-life events.

On Vacation

When I told people I was going to Bangkok and Tokyo in August, they said I must be crazy. But as I prepare to leave the Washington, DC area, the local temperature is hovering somewhere north of 100 degrees fahrenheit. Can it possibly be any hotter than this? See you in late August.

Satisfied Seniors and the Fall Campaign

The Kaiser Family Foundation's latest public opinion poll shows four in five seniors satisfied with the new Medicare drug benefit. This was totally predictable, and bad news for Democrats who were banking that widespread dissatisfaction with the plan would become an Achilles heel for Republicans in the fall elections.

As I pointed out last spring, most seniors without previous drug coverage and in relatively decent health probably take at most one or two prescription drugs for the chronic conditions of aging like elevated blood pressure or high cholesterol or mild arthritic pain. That can really add up after a while . . . to $300 a month or more. What did the Medicare drug benefit do for them? The government, in exchange for a $30 monthly premium, now picks up about two-thirds of that cost. What's there to complain about?

For those seniors taking lots of drugs who make payments of $1,000 a month or more, the new benefit provided real benefits, too. Yes, it will be a terrible disappointment to begin making payments again when you reach the so-called "donut hole" in the coverage, but, hey, how much were you paying before? And after two or three months without coverage, you will be back on the government nickel. Again, how many people will become angry because their new benefit didn't go far enough?

The sad reality is that the design of the benefit (no negotiations between the government and the drug companies; no discounts for volume; no strict formularies to get rid of the pricier drugs that have perfectly suitable generic substitutes) means that the government is turning over to the drug companies more than enough money to eliminate the donut hole entirely.

This is your classic Washington ripoff. Everybody gets a little something out of the program except the taxpayer who foots the bill.

So now we can simply add the Medicare drug benefit to the overall health care gouging that goes on in America, where the percent of GDP devoted to medicine last year soared above 16 percent and is headed higher.

I will spend as little time as possible contemplating that fact while on my sojourn in Asia. The wars in the Middle East may pause (they never end); the Republican Party's November prospects may revive; hell, the Washington Nationals may get hot and finish in the first division.

But skyrocketing health care costs? Some things never change.

No Drug Ads in Medical Journals?

If a medical journal refuses to take advertising from drug companies, it that an unconstitutional limit on freedom of speech? Pharmaceutical Research and Manufacturers Association (PhRMA) chief Billy Tauzin, the former Congressman, went so far as to complain of "human rights abuses" when George University professor Adrienne Fugh-Berman suggested (in an article in PLoS Medicine) that medical journals adopt such policies.

After receiving a lot of flack (including being charged with hypocrisy since at least one drug company official sits on its board), the open-source journal fired back in a hard-hitting editorial, which you can read here.

The core of their response concludes:

This is nonsense. Drug advertising is often misleading, and it can potentially distort clinical practice. The need to prevent another Vioxx tragedy, in which the “drug marketing got well ahead of the science, ” requires us all to think carefully about the net effect upon society of drug adverts. Public health must always come before industry's unfettered “rights.”

Marketers Challenge State Patient Privacy Law

Did you know that your physician's prescribing patterns are an open book to the nation's drug companies? If most people knew, how do you think they'd feel?

New Hampshire earlier this year became the first state in the nation to prohibit drug marketers from gaining access to information about how doctors prescribe drugs. The law, backed by AARP, most public health officials and privacy rights activists, was designed to stop data mining companies from compiling that information and selling it to drug companies, who pass it along to their door-to-door salesmen (known as detailers in the trade).

Now, two of those companies, IMS Health and Verispan, have asked a federal court to declare the law an unconstitutional abridgment of freedom of speech. The lawsuit also claims restricting access to that data will impede research. According to the online news site, FDA Webview (subscription required), the law allows the release of aggregate prescriber data and does not prohibit information from being used for care management, clinical trials, and education.

IMS Health and Verispan earn their livings by selling data to the drug industry's marketing arms. But when someone passes a law to protect patient privacy, they pull out the research card. I've yet to see a clinical trial report that breaks down data by the sites where that data was collected, much less by the physicians who participated in the trial. Who are they trying to kid with this lawsuit?