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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 09-13-2006

Stanford Bans Taking Freebies From Drug Companies
Los Angeles Times, 9-13-06

Editor's Notes:

Pharmaceutical and medical device companies have been widely criticized for exerting an untoward influence on medical practice by "detailing" doctors and promoting newer and pricier products over the old reliables. Critics have called for the elimination of "commercialism" from the practice of medicine.

It seems at least one prominent academic medical center has been persuaded. In response to a highly influential article in the Journal of the American Medical Association, Stanford's medical center has agreed to take the unprecedented step of banning all "freebies" from companies—including pens, magnets, and other gifts.

Critics of pharmaceutical marketing practices applauded the move, saying any gift can create a sense of loyalty or obligation, whether or not a physician realizes it.

"It's about time that this happened," said Alan Cassels, coauthor of "Selling Sickness: How the World's Biggest Pharmaceutical Companies Are Turning Us All Into Patients."

"If they're being wined and dined at lavish dinners, how can they be objective or how can they get a balanced picture of the benefits or harms related to drugs?"

Industry officials objected to the move, saying it would interfere with the relationship between pharmaceutical representatives and doctors. For instance, the policy would prohibit company-catered educational sessions and keep representatives from meeting with doctors unless they have appointments.

"Restricting the ability of sales representatives to give healthcare professionals valuable drug usage and safety information—which is designed to benefit patients—would be a serious mistake," said Scott Lassman, a lawyer for Pharmaceutical Research and Manufacturers of America, an industry trade group. "The fact is America's pharmaceutical research companies naturally have the most comprehensive information about the medicines they research and develop."

The change comes as physicians—especially at academic medical centers such as Stanford—have come under increased scrutiny for possible conflicts of interest as they accept handouts from pharmaceutical companies ranging from tchotchkes to paid trips. …

"The academic medical center is a place medicine looks for leadership. It's looked for moral medical guidance," said Arthur Caplan, director of the Center for Bioethics at Penn. "They are just places…where you try to keep the commercial aspect absent."

There is wide agreement that direct financial conflicts of interest should be routinely disclosed and there remains a serious debate on how to best structure incentives for improved patient care. But Stanford's policy seems to be about protecting the moral authority of doctors rather than advancing patient care.

Before market incentives are decried, let alone prohibited, we ought to have a real debate—with real evidence—about their role in health care.

It is instructive to consider how patient care in the least commercialized sectors of U.S. health care measures up to standards.

Unlike the other sectors of the American economy that are endowed with information technology and consumer choice, health care is basically a black box—one where even poor performers can flourish indefinitely.

Doctors fresh out of med school, for instance, tend to provide better care than their older compatriots who may lack up-to-date medical information. And studies show that American patients receive recommended care only about 50% of the time—for reasons that have nothing to do with drug companies' marketing budgets.

Doctors, no less than the rest of us, tend to be creatures of habit. Companies disrupt those habits by marketing new products and new treatments; they drive patients to doctors' offices with their own opinions about how their illnesses should be treated, challenging a doctor's ingrained authority. This, understandably, ruffles a lot of medical feathers.

By challenging received authority, the oft-decried commercialization of medicine spurs the dissemination of new technologies, allowing for the possibility of improved clinical practice. David Cutler has observed that direct to consumer advertising for SSRI drugs during the 1990s helped revolutionize the treatment of depression:

"We have all seen the ads for antidepressant medications—formerly sad people beaming with happiness. Many people approach doctors because of the ads, and doctors are more receptive to patients with the condition as a result of pharmaceutical companies efforts…This behavior [direct to consumer advertising] is repulsive to many analysts and I understand why…But the lesson that many draw—that the government should prohibit advertising and detailing—is not the right one. We need to remember the good side of this behavior—pharmaceutical company outreach gets depressed people into the doctor's office and on medication." Your Money or Your Life, Oxford University Press, 2004

Hindering timely access to the newest medical information only slows innovation and prolongs suffering.

This is not to say that companies don't sometimes over-reach, or that marketing is always done ethically. But throwing the baby out with the bathwater, as Stanford is doing, is not the solution.

It is possible, perhaps, that practitioners in the medical community remain leery of market incentives because they challenge physicians status as the sole gatekeepers of medical information.

Marketing efforts by pharmaceutical and medical device companies expose their products and performance to criticism—and this is exactly as it should be. Doctors can sort through medical studies to reach their own conclusions and consumers can use intermediaries from Consumer Reports and Web MD to do the same. When all is said and done, patients and doctors benefit far more from the heated competition of profit-driven medical research than from the isolation of an insular ivory tower.

[permanent link]

Study Finds Higher Risk of Heart Attack with Vioxx
The New York Times, 9-13-06

Editor's Notes:

This article provides yet more grist for the litigation mill, recounting new studies in a recent issue of the Journal of the American Medical Association detailing the relative risks of Vioxx compared to other widely used painkillers:

Vioxx, which is no longer on the market, may have posed heart risks that a similar drug, Celebrex, and other painkillers do not, according to two papers published yesterday by The Journal of the American Medical Association.

In one paper, three researchers at Harvard examined 114 clinical trials of Vioxx and other drugs and found that Vioxx was linked to substantially higher rates of increased blood pressure than was Celebrex, a similar painkiller, which is still sold.

In the other paper, two Australian researchers found that Vioxx appeared more dangerous than Celebrex or several older painkillers in observational studies, which examine the safety and effectiveness of drugs in real-world settings after they are approved.

These conclusions were hardly surprising. Merck, which makes Vioxx, stopped selling the drug in 2004 after a clinical trial showed that it sharply increased the risk of heart attacks and strokes.

But the papers provide new grist for the debate over whether all painkillers raise heart risks, or whether Vioxx is uniquely dangerous.

This article reminds us that pre-market clinical trials are often too small to detect safety signals that may only emerge when a drug is used by a large population. Some observers have used this logic to advocate for longer and larger pre-market trials to rule out rare side effects.

A better approach would be to encourage companies to conduct postmarket surveillance studies in return for protection from punitive damages suits, and in connection with an administrative compensation system modeled on the Vaccine Injury Compensation Program.

After all, we don't want fewer new medicines—we just want to use the ones we have with greater safety and effectiveness.

[permanent link]

Government Sets Higher Medicare Rates and New Surcharge
The New York Times, 9-13-06

Editor's Notes:

CMS Administrator Mark McClellan has helped navigate Medicare through turbulent waters, including the adoption of the Medicare Part D drug benefit. But one of the least noticed changes to Medicare under his watch may turn out to be the greatest harbinger of things to come: means-testing for Medicare recipients.

The basic Medicare premium will rise next year to $93.50 a month, an increase of $5, the Bush administration announced Tuesday. It said more affluent beneficiaries would have to pay a new surcharge, from $12.50 to $68.60 a month, depending on their incomes. The surcharge applies to 1.5 million people with annual incomes exceeding $80,000 for individuals or $160,000 for married couples filing joint tax returns. …

The premium in question is for Part B of Medicare, a voluntary program that covers doctors' services, diagnostic tests and outpatient hospital care for 40 million people who are 65 and older or disabled. It shot up 50 percent from 2003 to 2006.

Dr. McClellan said the surcharge would have "a very positive impact, making Medicare more sustainable in the long term." Some Medicare experts say the higher premiums will prompt some wealthy people to drop out of Medicare, leaving the program to serve poorer, sicker people. Dr. McClellan dismissed those concerns, saying Medicare would still be a bargain for high-income people. …

In announcing the new premiums, the administration appeared to send a mixed message. On the one hand, Dr. McClellan said, "Medicare beneficiaries are experiencing cost increases that are modest in comparison with recent health care cost trends." On the other hand, he said, spending in the traditional fee-for-service Medicare program is "out of control."

The Times, however is wrong: Dr. McClellan isn't offering a mixed message. Medicare is very heavily subsidized for all of its recipients, and recent cost increases are modest. But the program is consuming an enormous and ever-growing share of federal revenues—in fact, Medicare reform poses a much more serious long-term fiscal challenge than Social Security. Means-testing the program—that is, having higher income seniors pay more for their coverage—will help the program remain sustainable over the long term.

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