Health Highlights: March 10, 2005

FDA Adds Black Box Warning for 2 Eczema Drugs Judge Dismisses Agent Orange Lawsuit Pope to Return to Vatican for Holy Week California Study Links 2nd-Hand Smoke to Breast Cancer Experts Suggest Euthanasia for Severely Disabled Newborns FDA's Own Data Shows Crestor Danger, Group Says

Here are some of the latest health and medical news developments, compiled by editors of HealthDay:

FDA Adds Black Box Warning for 2 Eczema Drugs

Due to a potential cancer risk, doctors should prescribe the two eczema drugs Elidel (pimecromium) and Protopic (tacrolimus) to patients only as directed and only after other eczema treatments have failed, according to a U.S. Food and Drug Administration Public Health Advisory issued Thursday.

The FDA also said it was adding a black box warning to the health professional labels on the two products and is developing a medication guide for patients.

The advisory follows recommendations made by the FDA's Pediatric Advisory Committee during its mid-February meeting. At that meeting, the committee reviewed research that showed that the risk of cancer in three different species of animals increased along with increases in the doses of the two eczema drugs.

The research material also included some reports of cancers in children and adults treated with Elidel and Protopic, the FDA said.

The companies that make the two eczema drugs have agreed to conduct research to determine if the drugs do pose a risk of cancer in humans and, if so, to what extent.

Elidel and Protopic are applied to the skin and control eczema by suppressing the immune system. Protopic received FDA approval in 2000 and Elidel was approved in 2001.

-----

Judge Dismisses Agent Orange Lawsuit

A U.S. federal judge dismissed Thursday a lawsuit charging U.S. chemical companies that made Agent Orange with war crimes against Vietnamese civilians.

The lawsuit was launched on behalf of about four million civilians and alleged that Agent Orange, used by the U.S. military during the Vietnam War, caused birth defects, miscarriages and cancer among the civilians. The lawsuit charged that the defoliant, which contains the toxic chemical dioxin, was a poison forbidden by international rules of war, the Associated Press reported.

Lawyers for more than a dozen chemical companies, including Dow Chemical and Monsanto, countered that they shouldn't be punished because they followed what they regarded as legal orders from the U.S. government.

The chemical companies' lawyers also said that, under international law, corporations are generally exempted from criminal and civil liability for alleged war crimes, the AP reported.

In his 233-page ruling, U.S. District Judge Jack B. Weinstein, of Brooklyn, N.Y., wrote: "There is no basis for any of the claims of plaintiffs under the domestic law of any nation or state or under any form of international law."

-----

Pope to Return to Vatican for Holy Week

Vatican officials said Thursday that the Pope will leave the hospital and return to the Vatican by the start of Holy Week on March 20.

Doctors advised the Pope to temporarily delay his departure from the hospital, but that was not an indication of any new complications, CTV News reported.

"The Holy Father, following the advice of his doctors, will extend his stay in the Gemelli Polyclinic by a few more days, in order to complete his convalescence which is progressing regularly," Papal spokesman Joaquin Navarro-Valls told reporters.

The Pope will likely appear again at his hospital window on Sunday, but it hasn't been determined if he'll speak, Navarro-Valls said. The Vatican also confirmed that the Pope will give his traditional blessing on Easter Sunday, CTV News reported.

Two weeks ago, the Pope was re-hospitalized to treat his second breathing crisis in a month. On Feb. 24, he had surgery to insert a breathing tube into his windpipe.

-----

California Study Links 2nd-Hand Smoke to Breast Cancer

A new California government study finds a link between second-hand cigarette smoke and breast cancer, a conclusion so controversial that even some anti-smoking advocates are disputing it, the Los Angeles Times reported Thursday.

The state Environmental Protection Agency said it based its findings on a review of recent health studies. Other recent government analyses of the same data have shied away from drawing a definitive connection between the two, the newspaper said.

"We're going against the prevailing idea that there is no effect of tobacco smoke exposure on breast cancer," said the report's lead author, Melanie Marty, of the EPA's Office of Environmental Health Hazard Assessment.

Those findings, however, were challenged by a top scientist with the American Cancer Society. "There still are substantial uncertainties about the studies on second-hand smoke and breast cancer," Dr. Michael Thun, chief of epidemiological research for the ACS, told the newspaper.

The report was issued as the state Air Resources Board debates whether to impose additional restrictions on public smoking.

-----

Experts Suggest Euthanasia for Severely Disabled Newborns

Two Dutch doctors have published guidelines under which babies born to a certain life of extreme physical suffering should have their lives ended by physicians, The New York Times reported Thursday.

Eduard Verhagen and Pieter Sauer of the University Medical Center in Groningen, are "convinced that life-ending measures can be acceptable in these cases under very strict conditions," they wrote in Thursday's New England Journal of Medicine. They said they composed their essay to address "blood-chilling accounts and misunderstandings."

Under the so-called Groningen protocol, conditions for ending a newborn's life at hands of a physician team would include full and informed consent of the parents, agreement by a team of medical experts, and a subsequent review of each case by "an outside legal body" to make sure the decision was justified and that all procedures were followed properly, the newspaper said.

Doctors often abort fetuses when extreme medical conditions like Tay-Sachs disease are diagnosed before birth, the two physicians say. Their protocol would establish formal procedures by which this could be done in the open, they say, as "we find it unacceptable that it is happening in silence," Dr. Verhagen told the newspaper.

A spokesman for Not Dead Yet, a U.S.-based group that views euthanasia as serious threat to people with disabilities, condemned the Groningen protocol as "singling out infants based on somebody else's assessment of their quality of life," the Times said.

-----

FDA's Own Data Shows Crestor Danger, Group Says

The consumer group that sparked a recent effort to ban the anti-cholesterol drug Crestor says the drug's ability to cause serious muscle damage in users is supported by the U.S. Food and Drug Administration's own adverse event reporting system.

In a new letter to FDA chief Lester Crawford, Public Citizen Thursday blasted the FDA's recent findings that Crestor posed no more of a risk of serious muscle damage (rhabdomyolysis) that other cholesterol fighters called statins. The group said its recent analysis of the AstraZeneca drug showed an adverse incident rate of 13.1 reports per million prescriptions -- "6.2 times higher than the rate all of the other statins combined," the letter said.

"Even compared to the rate of the statin having the second-highest rate of reports (Zocor/simvastatin), Crestor is 2.8 times higher," the letter continued.

Earlier this month, the FDA rebuffed calls to remove Crestor from the market.

Consumer News