Tag Archives: heparin

Barlett & Steele uncover chaos, peril of global drug industry

In Vanity Fair, Donald Barlett and James Steele have devoted more than 6,000 words to chronicling the gaping holes in the global pharmaceutical industry, particularly as pertains to the globalization of clinical trials. Even if you’re familiar with many of the specific incidents covered, their cumulative effect, driven home with forceful and authoritative prose, is brutal. Each paragraph holds another tale of trials gone wrong, children killed and bad results that somehow never came to the attention of American regulators.

globePhoto by amyvdh via Flickr

It used to be that clinical trials were done mostly by academic researchers in universities and teaching hospitals, a system that, however imperfect, generally entailed certain minimum standards. The free market has changed all that. Today it is mainly independent contractors who recruit potential patients both in the U.S. and—increasingly—overseas.

They devise the rules for the clinical trials, conduct the trials themselves, prepare reports on the results, ghostwrite technical articles for medical journals, and create promotional campaigns. The people doing the work on the front lines are not independent scientists. They are wage-earning technicians who are paid to gather a certain number of human beings; sometimes sequester and feed them; administer certain chemical inputs; and collect samples of urine and blood at regular intervals. The work looks like agribusiness, not research.

After neatly setting up each pin with demonstrations of how international the pharmaceutical industry has become, then proceed to knock them all down with examples of industry impunity and FDA weakness.

The F.D.A., the federal agency charged with oversight of the food and drugs that Americans consume, is rife with conflicts of interest. Doctors who insist the drug you take is perfectly safe may be collecting hundreds of thousands of dollars from the company selling the drug. … Quite often, the F.D.A. never bothers to check for interlocking financial interests. In one study, the agency failed to document the financial interests of applicants in 31 percent of applications for new-drug approval. Even when the agency or the company knew of a potential conflict of interest, neither acted to guard against bias in the test results.


WikiLeaks cables: Pfizer used dirty tricks to avoid clinical trial payout in Nigeria

Quaid reaches settlement with hospital over errors

If you attended Health Journalism 2008 in March, you likely heard actor Dennis Quaid give an emotional talk about the medication error that nearly killed his newborn twins.

Dennis Quaid speaks to attendees at Health Journalism 2008 in Arlington, Va., in March. Photo: Carrie Devorah

Dennis Quaid speaks to attendees at AHCJ's annual conference, Health Journalism 2008 in Arlington, Va., in March. Photo: Carrie Devorah

During the talk, Quaid said he was considering a suit against Cedars-Sinai Medical Center, where the twins had received a dose of the blood thinner heparin that was 1,000 times what they should have gotten.

The Los Angeles Times reports today that Quaid and his wife, Kimberly, have reached a $750,000 settlement with the hospital. The Times says that “Cedars-Sinai Medical Center was not sued, though the hospital was described in a court filing as a ‘potential defendant.'”

The couple still has a suit pending against Baxter Healthcare Corp., which made the heparin. The Quaids started the Quaid Foundation in hopes of raising the standard of patient care and reducing errors in hospitals.

Reminder: Health Journalism 2009 will be in Seattle, April 16-19.