Some question doctor's drug ethics

Some U.S. health ethicists are calling into question a Boston doctor's offer to include patients infected by hepatitis C by a hospital worker in a drug trial. Prosecutors allege a former hospital technician, 33-year-old David Kwiatkowski, stole syringes of the anesthetic fentanyl from the cardiac catheterization lab, injected himself, and then returned the tainted needles, which were reused on patients. Some 30 patients in New Hampshire were infected with hepatitis C, which over time could attack the liver and can ultimately lead to death, but some treatments are available. In the past, hepatitis C was treated by giving weekly injections with interferon, which cures fewer than half of patients with the most common form of the virus and can produce flu-like side effects. But last year, the U.S. government approved two new drugs, Vertex Pharmaceuticals' telaprevir and Merck & Co.'s boceprevir, which taken in combination with interferon increased cure rates to roughly 80 percent and 65 percent, respectively. Dr. Raymond T. Chung of Harvard Medical School and Massachusetts General Hospital, who is involved in a hepatitis C drug trial, spoke before about two-thirds of the patients infected in New Hampshire at a "Hepatitis C Patient Information Night" organized by an attorney to learn about new treatments and the possibility of a medical malpractice lawsuit, The Boston Globe reported. Chung said his promise of the drugs and his desire to make them available to patients who could benefit most conformed to ethical standards for clinical trials. However, five ethicists and researchers reviewed Chung's comments at the Globe's request and said they appeared to violate ethical standards requiring researchers to convey a balanced message about the drug trial's risks, benefits and side effects. "It's inappropriate, and I would argue unethical, to approach people about a research study that hasn't been approved and to say the potential benefits outweigh the risks," Dr. Michael Grodin, a bioethicist at Boston University's public health school, told the Globe.