News in brief - May 3, 2004

Final data from WHI's estrogen-only arm published - Are politics stalling OTC status for emergency contraceptives? - Smallpox trial halted - Gentle injection method tested

Final data from WHI's estrogen-only arm published

Estrogen-only hormone therapy for postmenopausal women does not affect coronary heart disease but increases the risk of stroke by 39% while decreasing the risk of hip fracture by 39%, according to a study published in the April 7 Journal of the American Medical Association.

Therapy was also associated with an increased risk of breast cancer, although this was not statistically significant, but no increased risk of pulmonary embolism or colorectal cancer was detected. Total cardiovascular disease was increased by 12% and all fractures were decreased by 30%.

"These findings confirm that estrogen-alone therapy should not be used to prevent chronic disease," said Barbara Alving, MD, Women's Health Initiative director and acting director of the National Heart, Lung and Blood Institute.

The National Institutes of Health announced in March that the estrogen-only arm of the WHI was being suspended because of an unacceptable risk of stroke. The combination estrogen-progestin arm was stopped in July 2002.

Are politics stalling OTC status for emergency contraceptives?

Politics are interfering with the impending switch of emergency contraception to over-the-counter status, and this may damage the Food and Drug Administration's reputation, according to an editorial last month in the New England Journal of Medicine. It was authored by the journal's editor and two members of the Food and Drug Administration advisory committee that backed the switch in December 2003.

The committee recommendation elicited joy from those who support the switch but chagrin from those opposed. The agency was expected to announce its final decision in February but instead announced a 90-day delay. An FDA spokeswoman said the postponement of the decision was due to receipt of additional information about adolescent use that needed to be considered.

"The FDA's final decision will be supported by sound science and in full compliance with the applicable laws and regulations, while taking into consideration the recommendations of these advisory committees," said Christine S. Parker, public affairs specialist at the agency.

Advocates are also worried that the drug may also only be available over the counter with restrictions such as age limits or putting it in view of the pharmacist. These measures were rejected by the advisory panel.

Smallpox trial halted

Enrollment in a phase III trial of a smallpox vaccine was suspended in early April when its manufacturer found that three cases of heart inflammation had developed in some volunteers in an earlier trial.

The manufacturer, Acambis, had already sold about 200 million doses of vaccine to the United States for use against a possible terrorist attack. No decision has been made on what to do with those doses and Acambis said it was reviewing the situation along with the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention.

The three cases of myopericarditis developed among 1,132 volunteers who received Dryvax, the traditional vaccine used against smallpox, as well as an updated version, ACAM2000, which was developed by Acambis.

As a precaution, the company halted a second phase III trial of 1,752 volunteers although no cases of the heart inflammation were discovered.

Findings from a U.S. smallpox vaccination program for civilians and the military also found a causal association between myopericarditis and vaccination, Acambis noted in a release.

Gentle injection method tested

A new, painless method of delivering drugs through the skin was described in BMC Medicine, which is published by BioMed Central, an independent online publishing house that offers open access to peer-reviewed medical research.

Using a technique called microscission, researchers used a stream of gas to bombard small areas of the skin with tiny crystals of inert aluminum oxide. The sharp particles remove the rough surface-layer of the skin and create tiny holes in the underlying layers of the skin. The crystals and loosened skin were taken away with the gas flow. The whole process took less than 20 seconds, said the researchers.

Volunteers said the technique felt like a gentle stream of air, much less painful than being pricked by a needle.

The Harvard-MIT Division of Health Sciences and Technology researchers tested the technique by attempting to anesthetize the skin through the microconduits. After using microscission to create four conduits in a small area, pads soaked with lidocaine were applied. Within two minutes the patch of skin was anaesthetized.