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Showing posts with label Wyeth. Show all posts
Showing posts with label Wyeth. Show all posts

Thursday, March 5, 2009

An incentive to do the wrong thing: A Phenergan injection lawsuit

Diana Levine is a guitarist, age 63, living in Vermont. She went to a clinic, complaining of pain from migraine headaches. A doctor there chose to inject her with Phenergan, an anti-nausea drug made by Wyeth Pharmaceuticals. Though the drug label permitted the drug's intravenous injection, it stated that "extreme care" was needed to avoid hitting an artery, because "likely" complications included "gangrene requiring amputation."

Unfortunately Diana immediately developed gangrene, and the musician's right forearm had to be amputated. She sued Wyeth, and won. The U.S. Supreme Court upheld the decision in a ruling today, by a vote of 6 to 3.

Diana’s case is especially significant because the Supreme Court's ruling enhances the rights of injured patients to hold drug makers responsible.

This case also implicates our payment system. Doctors are paid well for administering injections, and are not paid for prescribing oral drugs, for example, that usually offer available alternatives. The reimbursement system provided an incentive to do the wrong thing, and Diana is suffering for it.

Advice: Consider a lawsuit if a medication error causes you significant injury.

Read a story about a migraine sufferer.

Thanks to Jess Bravin; and Joan Biskupic and Julie Appleby for the source articles in today's Wall St. Journal and USA Today, respectively.

Friday, January 18, 2008

The Animal House of drug research units: Human subjects – guinea pigs

On Sept. 11, 2001, James Rockwell was camped out in a clinical-research unit on the 11th floor of a Philadelphia hospital, where he had enrolled as a subject in a high-paying drug study. As a rule, studies that involved invasive medical procedures are more lucrative – the more uncomfortable, the better the pay – and in this study, subjects had a fiber-optic tube inserted in their mouths and down their esophaguses so that researchers cold examine their gastrointestinal tracts.

James had enrolled in many previous studies at corporate sites at places like Wyeth and GlaxoSmithKline. But the atmosphere there felt professional, bureaucratic, and cold. This unit was in a university hospital, not a corporate lab, and the staff had a casual attitude toward regulations and procedures. "The Animal House of research units" is what James calls it. "I'm standing in the hallway juggling," he says. "I'm up at 5:00 in the morning watching movies." Although study guidelines called for stringent dietary restrictions, the subjects got so hungry that one of them picked the lock on the food closet. "We got giant boxes of cookies and ran into the lounge and put them in the couch," James says. "This one guy was putting them in the ceiling tiles." James has little confidence in the data that the study produced. "The most integral part of the study was the diet restriction," he says, "and we were just gorging ourselves at 2 am on Cheez Doodles."

On the morning of Sept. 11, nearly a month into the five-week study, the subjects gathered around a TV and watched the news of the terrorist attack through a drug-induced haze. "We were all high on Versed after getting endoscopies," James says. He and the other subjects began to wonder if they should go home. But a mass departure would have ruined the study. "The doctors were, like, 'No, no!'" James recalls. "No one's going home, everything’s fine!" James stayed until the end of the study and was paid $7,500. He used the money to make a down payment on a house.

Over the years, James has enrolled in more than 20 studies for money. Today, fees as high as he received aren't unusual. Some people enroll in one drug study after another. For them, "guinea pigging" has become a job.

Browse for similar stories in our index at the very bottom of this page, or read another human guinea pig story.

Thanks to Carl Elliott for the source story In the Jan. 7 issue of the New Yorker.