News in brief - Nov. 7, 2005

Study raises alarm about potential new diabetes drug's safety - Polio cases found in Minnesota in unvaccinated Amish children - Cancer patients keep mum about alternative therapies

Study raises alarm about potential new diabetes drug's safety

A diabetes drug being considered by the Food and Drug Administration increases death and major cardiovascular events and should not be approved by the agency, according to a study published online Oct. 20 by the Journal of the American Medical Association.

Cleveland Clinic Foundation researchers reviewed the documents considered by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee that recommended muraglitazar (Pargluva) for approval at its September meeting. The agency since has issued an approvable letter for the drug and requested additional data related to cardiovascular safety.

"We are eager to begin discussions with the FDA to address more fully the cardiovascular safety profile of the compound and to determine what additional information may be necessary," said Tony Plohoros, Bristol-Myers Squibb corporate spokesman.

The study suggested that the drug could more than double the risk of death, heart attack and stroke, and researchers are particularly concerned that most of these events occurred after patients had been on the drug for a relatively short period of time.

"Muraglitazar should not be used or approved to treat patients with diabetes until an appropriate dedicated trial to assess cardiovascular outcomes is performed," the authors wrote.

Polio cases found in Minnesota in unvaccinated Amish children

Four unvaccinated children in central Minnesota tested positive for the polio virus, according to the Oct. 14 Morbidity and Mortality Weekly Report and statements issued by the Minnesota Dept. of Health over the past month.

The children are all members of the Amish community in the central part of the state and were infected with a vaccine-derived form of the virus. None were sickened by it, but this is the first documented incident of transmission of this variant of the virus since the United States stopped using the oral polio vaccine in 2000. Public health officials who genetically sequenced the virus suspect that it was brought in by a person from a country that still uses this vaccine and has been circulating in the community for about two years.

About 93% of the state's children are fully vaccinated, although rates are low among the Amish. Public health officials are offering the inactivated version of the vaccine to health care workers who may have been exposed, as well as to the members of this community.

The last wild poliovirus outbreak in the United States occurred in 1979 in several religious communities, including the Amish, that shunned vaccination.

Cancer patients keep mum about alternative therapies

Nearly half of all patients being treated for cancer also are using complementary and alternative treatments, but few tell their physicians, according to a study presented at the American Society for Therapeutic Radiology and Oncology meeting in Denver last month.

Researchers at the University of Pennsylvania in Philadelphia surveyed nearly 500 cancer patients about their use of vitamin supplements, massage and other alternative strategies. About 48% were using these or other modalities, although those who were being treated with chemotherapy were far more likely than those being treated with radiation to take this route. Only 36% consulted their physician about these therapies.

"This study shows the significant lack of communication between patients and their doctors about the use of complementary and alternative medicines," said Neha Vapiwala, MD, lead author and a radiation oncologist at the university.