Headlines: April 28, 2010
by Meg Larkin
In legal news, a federal judge in Minnesota has rejected the plea agreement that was reached between device-maker Guidant and the federal government. Guidant was facing two misdemeanor charges after it was found that the company failed to disclose a defect in its defibrillators, which led to the deaths of at least six people. Judge Donovan W. Frank said in his opinion that the plea arrangement was not in the best interests of justice because, it does not “adequately address Guidant’s history and the criminal conduct at issue.” Many patients and physicians had urged Judge Frank to reject the deal, because Guidant executives should be federally charged, but Judge Frank pointed out that charging decisions are to be made by the prosecutor’s office. Judge Frank suggested that Guidant should have been put on probation because of the nature of its conduct, and that Guidant also might be encouraged to participate in charitable activities.
In other legal news, AstraZeneca has settled a $520 million case over the marketing of its antipsychotic drug Seroquel. Attorney General Eric Holder announced that the drug maker will sign a corporate integrity agreement in addition to paying the fine. AstraZeneca was accused of illegally marketing the drug for off-label use in children and the elderly. It was also alleged that the drug maker “buried” studies that linked Seroquel to higher rates of diabetes. Last year, Seroquel was the fifth best selling drug in the United States.
In research news, a Genentech drug has been found to prevent vision loss in diabetics. Lucentis was found to improve the vision of patients suffering from diabetic macular edema better than laser therapy alone. Lucentis is already on the market, but it is currently only approved to treat age-related macular degeneration. According to the New York Times, “Nearly half the people whose eyes were treated with Lucentis, often in combination with standard laser therapy, had an improvement in vision of at least two lines on an eye chart after one year. That compared with only about 30 percent of those receiving laser therapy alone. And fewer people treated with Lucentis experienced a big loss of vision. “ Genentech faced some criticism for choosing to run the trial using Lucentis instead of its cancer drug Avastin, which is cheaper and also currently used off-label to treat eye problems.
Finally, a British study has found that a simple test could dramatically reduce colon cancer deaths. The “flexi-scope” test uses a pen-sized tube to find and remove polyps in the lower colon, is far less invasive than a colonoscopy, and needs to be performed only once. The flexi-scope test was found to reduce patient’s risk of getting colon cancer by one third, and reduced the risk of dying from the disease by 43%. The results of the study were published in the Lancet.
Meg Larkin is a second year law student at Boston University. Please feel free to email her with any questions, comments, suggestions, or concerns.
Meg will be off on Friday, but the blog will return as usual on Monday.
