Most people who read this blog understand how drug companies use their reps to try to influence the kinds of medications that physicians prescribe. The question is: do they really have an effect on how most doctors practice medicine? 

Below, an insider’s look at how drug reps operate from the Carlat Psychiatry Blog. A former Eli Lilly rep may sum it all up when he says: “Gift giving is the key. You are programmed as a human to reciprocate . . . As a matter of fact, the smaller the gift, the greater the sense of obligation.”

Thursday, March 27, 2008 : A Drug Rep Tells All

Shahram Ahari, former Eli Lilly drug rep, recently spoke to the Tufts Progressive Medical Students Organization. It was a fascinating talk, because Ahari told us about how he and his colleagues used every trick of salesmanship in the book to increase prescriptions of Prozac and Zyprexa and therefore to maximize their bonuses.

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It is time, I think, to face the realpolitik of health care reform. That means asking a question few reformers dare to discuss:  How will we win the Congressional votes needed to pass serious health care reform?

The American Prospect’s Ezra Klein put this question on the table at the “Take Back America” conference last week.  A pragmatic progressive (in the best sense), Klein pulled no punches:  “There are so many people in this town [D.C.] who do such smart policy thinking,” he observed. But “what we don’t give enough thought to is the politics of reform. This is a political problem. Until we have the votes in the Senate, we can’t get anything done.”

Without the votes, Klein told reformers, “you don’t have a plan; you have a position.”

Some assume that, if we elect a progressive president, he will “put the votes together” to achieve reform. But the fact is that even an optimistic, charismatic JFK wasn’t able to persuade Congress to unite behind healthcare for the elderly in the early 1960s—a time when seniors were the poorest group in America. It was only after Kennedy was assassinated that a wily LBJ (who had grown up in Congress and knew where all of the bodies were buried on the Hill) was able to leverage a martyred president’s last wishes to help pass Medicare in 1965. The fact that LBJ had won by a landslide sealed the deal.

This time around, nailing the votes that would secure something like “Medicare for Everyone Who Wants It” will be much tougher. As I noted in my first post in this series, “Obstacles to Health Care Reform,” the lobbyists representing the for-profit health care industry enjoy enormous power. The money at stake in the health care industry has grown exponentially since 1965. And thanks to generous campaign contributions, the industry’s lobbyists wield great influence, even among liberal politicians.

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Finally, the National Association of Government Employees (SEIU) has responded to the story I posted last week reporting that its affiliate, the International Association of EMTS and Paramedics (IAEP/SEIU), has been sending out letters to doctors, endorsing Pfizer’s blockbuster drug Lipitor.

Lipitor, like other statins, has been getting some bad publicity of late (see “The Cholesterol Con”) and apparently someone decided Lipitor needed a boost.

Today, I learned that someone who signed himself “anonymous” had replied to my post on Health Care Renewal, where Dr. Roy Poses, the blog’s editor, had cross-posted my SEIU piece. Here’s the response:

SEIU Does Not Endorse Lipitor or Any Other Product (Full disclosure—I work for SEIU.) If Ms. Mahar had bothered to contact us, she would have learned that as a matter of policy, SEIU does not endorse products. Official Statement from SEIU: Recently, a letter appearing to endorse a well-known pharmaceutical was circulated by the International Association of EMTS and Paramedics, an affiliate of the National Association of Government Employees (IAEP/SEIU).SEIU does not endorse products. The letter was generated by a Local Union staff member unfamiliar with SEIU’s policy against any product endorsement. Upon learning of the letter, the Local disavowed a relationship with the product in keeping with the union’s policy.

The 1.9 million member Service Employees International
Union is united by the belief in the dignity and worth of workers and
the services they provide and dedicated to improving the lives of
workers and their families and creating a more just and humane society.
SEIU members are winning better wages, health care, and more secure
jobs for our communities, while uniting their strength with their
counterparts around the world to help ensure that workers, not just
corporations and CEOs, benefit from today’s global economy.

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Reforming U.S. healthcare will be difficult,  in part because our current system is riddled with conflict of interest. Virtually any health care reformer will tell you that if we are going to have a high quality, sustainable health care system, we will need an independent health care agency that oversees quality by making sure that decision are based on the best medical science available. “Independent” means that this agency must somehow be insulated from both special interests and politics.

If this sounds Utopian, it isn’t. In my first post, I suggested that we might find a model for just such an agency in the U.K.’s National Institute for Health and Clinical Excellence (NICE). To be sure, we would not want to emulate NICE in all respects. Operating on a very tight budget, NICE puts a major emphasis on the cost-effectiveness of the treatments it approves. In the U.S., we could  vastly improve the quality of our care—and save billions—if we just looked at the “comparative-effectiveness” of services and products, without worrying about how many additional years of life $100,000 would buy.

What is remarkable about NICE is its independence. And this is what we should take as a pattern for what is possible.  Founded in 1999, the institute operates with almost no interference from either private sector lobbyists or government.

Sitting at the very center of the U.K.’s health care system, NICE is charged with watching over the quality of care in the U.K. by drawing up “best practice guidelines” for physicians, while also reviewing new and existing medicines, technologies and treatments. The National Health Service of England is legally obliged to provide funding for drugs and procedures recommended by NICE’s independent technology appraisal board. So implicitly, NICE also is deciding what the national health system will cover.

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Today, AlterNet published a provocative story by Mark Weisbrot , co-director and co-founder of the Center for Economic and Policy Research, about the emerging battle between Big Pharma and the developing world.

Some large pharmaceutical companies are “up in arms,” Weisbrot notes, because “developing countries are importing less expensive generic versions of drugs for which these companies hold a patent monopoly.”

But “the procedure is perfectly legal, even under the World Trade Organization’s pro-pharmaceutical-monopoly rules. The only question is whether these huge corporations –who used their political muscle in Washington to prevent our government from lowering the price of Medicare prescription drugs—will intimidate governments that are trying to provide essential medicines to their citizens.”

Weisbrot points to Thailand as “the latest target of this bullying last winter when it issued ‘compulsory licenses’ for three drugs. Two were anti-AIDS drugs (efavirenz and lopinavir/ritonavir) and the third is used to treat patients with cardio-vascular disease (clopidogrel). A compulsory license allows for the production or import of a generic version of a patented drug, without the permission of the patent holder. It is completely legal, and in fact the United States has used compulsory licenses many times.

“But the U.S. government has sided with the big pharmaceutical companies and put Thailand on a special ‘Priority Watch List,’ which could potentially lead to trade sanctions against Thailand. Actual sanctions are unlikely, but Washington and its pharmaceutical allies have made a serious threat. Now that pressure is reportedly being used to block similar licenses for three cancer drugs”

Below, I’ve reprinted the rest of Weisbrot’s story. He makes a powerful argument that countries like Thailand are trying to do what is right for their citizens.

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After 10 hours on the job, a truck driver must pull off the road. After 16 hours, an airline pilot can no longer legally fly a plane. But after 24 hours or more on the job, with perhaps an hour nap somewhere along the line, a first-year medical resident can perform a surgical procedure, write a prescription, or insert a chest tube.

This introduction to a 2004 article in Focus Online, the newsletter from Harvard Medical, Dental, and Public Health Schools, says it all: we expect doctors to be superhuman.

When you stop and think about it, the expectation that medical residents, especially first-year interns, can, or should, perform incredibly complex procedures with minimal sleep is crazy. Medical researches agree—which is why hospital shifts of doctors-in-training have come under much scrutiny in recent years.

In 2003, the Accreditation Council for Graduate Medical Education (ACGME) created standards to restructure residents’ hours in order to combat fatigue, and the dangerous mistakes that accompany exhaustion. The council’s reforms limited residents’ hours to:

• No more than 80 hours a week
• No more than 6 work days a week, averaged over 4 weeks
• No more than 24 continuous hours of duty, except for another 6 hours of education or transfer of care In-house call no more often than every third night
• No less than 10 hours of rest between duty periods

These changes were meant to benefit not only residents, but also patients: an exhausted doctor is a careless doctor. But for all of the Council’s good intentions, studies show that the ACGME reforms don’t go far enough—residents need more of a break if they are to maximize their effectiveness and ensure the safety of their patients.

How do we know?  Last year, two studies from Kevin G. Volpp, MD, PhD, from the Center for Health Equity Research and Promotion, VA Hospital in Philadelphia, Pennsylvania looked at whether the first four years of the ACGME guidelines had resulted in a meaningful decline in patient mortality—in other words, if the guidelines had saved lines by keeping doctors alert and rested.

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Imagine a society that lets its automakers oversee crash tests on new models, allowing the industry to report results, as it sees fit, to government and consumers. Sometimes, an automaker might not reveal the outcome of a test that turned out badly, deciding that the dummies in the vehicle had been too short—no wonder their chests were crushed!

In other cases, a company might postpone reporting on crash test results for a year or two, hoping that later trials would turn out better. In these cases dozens of trials might be required in order to achieve the desired outcome. The car maker would, of course, pass the additional costs along, in the form of higher sticker prices.

In this society, crash tests are not run and paid for by an independent entity like our National Highway Traffic Safety Administration (funded by taxpayers) or the Insurance Institute for Highway Safety (funded by insurers). Instead, the auto industry itself finances and controls the trials. Automakers also provide most of the funding for the government agency that rules on car safety. Finally, under this system, head-to-head comparisons of cars in a similar weight class are frowned upon. Such trials would create winners and losers—and who wants to be a loser? Instead, each company tests its own cars, and when outcomes finally are published, they tend to be excellent.

Probably you already have guessed where I’m heading.  The system I’ve sketched comes pretty close to describing how we try to assure the safety of the prescription drugs and medical devices sold in the U.S. We may be the only country in the developed world that allows the companies that manufacture and peddle medical drugs and devices to control what we know about them.  The industry also provides much of the funding for the Food & Drug Administration, the agency responsible for weighing the risks and benefits of these products. No wonder the FDA doesn’t require manufacturers to test their products against similar, less expensive products already on the market. Instead, the FDA asks only that the sponsor to test its new entry against a placebo—demonstrating that it is “better than nothing.”

In the U.S., medical research is rife with conflicts of interest. As Merrill Goozner recently testified before the Institute of Medicine (IOM) panel on “Conflict of Interest in Medical Research, Education, and Practice,” the  share of our clinical research funded by industry has doubled over the past 30 years, and now accounts for well over 60 percent of all clinical trials. As a result, Goozner testified, the medical literature is riddled with:

• reports of negative research results being suppressed
• delays in publication 
• failure to report serious adverse events in clinical trials
• the slanting of systematic reviews of medical evidence
• and a systematic bias in research results that favors the outcomes desired by study sponsors.

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Be sure to take a look at the latest edition of Health Wonk Review (HWR) on Joe Paduda’s excellent blog, “Managed Care Matters” (http://www.joepaduda.com/archives/001157.html)

HWR offers a round-up of some of the most insightful health blogs posts of the past two weeks including a post explaining the source of the opposition to universal coverage in San Francisco by Anthony Wright, and a Health Affairs analysis of the  crash and burn of the health reform initiative in California, and Tom Lynch’s four-part post on why the U.S. health care system is nowhere near the best in the world.

Joe himself offers a provocative “modest solution to the ever-growing problem of ever-increasing pharma costs by establishing a cap on national drug costs, allowing the market to figure out the best way to meet that cap, and if the market fails, requiring the Feds negotiate for price and allowing any and all payers access to that negotiated pricing.”

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A couple of weeks ago Dr.  Alicia Fernandez, an associate professor of clinical medicine at UC San Francisco, received a very unusual letter from The International Association of EMTS and Paramedics, an affiliate of The National Association of Government Employees (IAEP/SEIU).

The letter began by noting that Fernandez is part of the union’s approved physician network, and then launched into what can only be described as a shameless sales pitch for Lipitor, Pfizer’s blockbuster cholesterol-lowering drug.

First, the alarming statistics presented in the letter:

• 1 in 3 adults has some form of CVD (cardio-vascular disease)
• About every 26 seconds, an American will suffer a coronary event
• Stroke is a leading cause of serious, long-term disability in the United States
• Every 45 seconds, someone will suffer a stroke. 

Then, the endorsement: “Lipitor is available to our members through their prescription plan. IAEP leadership stands behind LIPITOR as the lipid-lowering agent of choice when it is prescribed by a physician. [my emphasis]  This confidence in LIPITOR is based on its proven efficacy and is supported by its vast clinical experience of more than 15 years…"

The letter went on, at length, to praise Lipitor’s benefits and to downplay the drug’s risks. In clinical trials, the letter states, “the most common adverse events were constipation, flatulence, dyspepsia and abdominal pain.” But while other risks may not be as “common” they are certainly worth mentioning. They include memory loss which can look like Alzheimer’s and severe muscle pain.

A few days ago, Fernandez received a second, identical letter.  Never before in her professional experience had she received a drug ad from a union.

“I’ve never seen anything like this. I’ve never seen Labor endorse a
drug product,” she told me. “This is incredible.” Unfortunately,
Fernandez adds, this is not the
first time that she has seen a drug company use a progressive
organization to promote its product.

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Of the oft-cited “frivolous lawsuits” supposedly decimating our nation, medical malpractice suits are probably public enemy number one—the bogeyman of our medical system that drives the nation’s health care price tag ever higher (or so we’re told).

In reality, medical malpractice settlements and awards account for less than one-half of a percent of our total health care bill—a relatively miniscule amount. Of course a half percent of 2 trillion is still a lot of money, which means that if tort reforms—changes to the legal code that make it more difficult and less rewarding for plaintiffs to sue doctors—were as vital as their proponents claim, we’d end up with some significant savings. But as it turns out, tort reform barely makes a dent on either the frequency of successful malpractice suits or the amount of money our system pays out to them.

A Health Affairs study from last year compared state laws to see if tort reforms have a strong effect on four “outcome variables”: the average amount of a paid malpractice claim, the total number of such claims, the average dollars per practicing physician of a paid claim, and the number of paid claims per practicing physician. Together, these variables comprise what we’re really thinking when we talk about personal injury law suits: how often people win their lawsuits, how much they get, and how these numbers compare to the number of doctors in a given region (in this case, a state).

The study’s authors, who hail from the University of Tennessee, the University of Oklahoma, and the Kaiser Foundation, found that “strong tort law provisions can explain at most only one-fourth of the variation among states in the average payment on a medical malpractice claim.” That means three-quarters of the differences in payment amounts across the states has nothing to do with tort reform!

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