Another gene therapy trial halted by FDA
The latest in a string of gene therapy trials halted by the U.S. Food and Drug Admin istration (FDA) involves a heart disease study.
The FDA announced the action in early March but declined to release details on why it halted the trials involving several hospitals across the country. The order comes on the heels of President Clinton’s order to review gene therapy guidelines based on reports that researchers failed to fully explain to patients the risks involved.
The trials, sponsored by Durham, NC-based Vascular Genetics, centered on growing new blood vessels around blocked leg and heart arteries in patients who could not undergo traditional treatments and procedures.
The studies involved nearly 100 patients at six hospitals. Most patients already had completed the trial, however, when the FDA halted the study.
Genetic information to remain private
President Clinton signed an executive order in February prohibiting the federal government from using genetic test results in hiring, firing, or promoting employees.
The order is similar to pending legislation sponsored by Sens. Tom Daschle (D-SD) and Edward Kennedy (D-MA). The bill would prohibit private-sector employers from refusing to hire people at potential risk for health problems. The bill also would prevent insurers from refusing to issue coverage to people at risk of developing conditions. President Clinton’s order affects nearly 2 million federal civilian employees. The order restricts federal agencies from collecting or using genetic information, including family medical histories.
Exceptions would be granted for workplace safety studies and workers who give written consent as part of a health care program that monitors their health.
Advance directives available on-line
A new service from the U.S. Living Will Registry in Westfield, NJ, allows hospitals to obtain advance directives from an on-line database. Patients first must register their advance directive, living will, or health care proxy with the free service.
Hospitals nationwide can access a 24-hour automated fax system to retrieve the information. Only hospitals will have access to the information, according to Joseph Barmakian, MD, founder of the service.
For additional information, visit the U.S. Living Will Registry on the World Wide Web: http://www.uslivingwillregistry.com. Telephone: (800) 548-9455.
Unusual scenario for Maryland’s suicide law
Maryland’s state attorney’s office used the state’s new assisted suicide law for the first time, but not in the manner it was intended.
A 16-year-old boy, charged as a juvenile, became the first person arrested in Maryland under the state’s physician-assisted suicide law, which took effect last October. The boy allegedly gave a gun to his girlfriend that month so she could kill herself. The boy was supposed to kill himself as well, authorities say, but changed his mind and left. He was arrested in February.
Law used, but not as intended
The author of the legislation, Maryland state Sen. Norman R. Stone, Jr., told the Washington Post in January 2000 that using the law in this instance was not out of question because the law is so broad. While Stone wrote the law with the goal of preventing the elderly and people with serious medical conditions from ending their lives, he said, he is not opposed to it being used in this case.
Maryland is one of 38 states to outlaw assisted suicide. Maryland’s law makes the practice and attempt of assisted suicide a felony punishable with a $10,000 fine and up to a year in prison.