Health Highlights: March 15, 2004

Consumer Group Sues FDA Over Antidepressant Feds to Start Counting Carbs Many Blood Pressure Patients Unaware of Health Risks: Survey Baldness Remedy May Lie in Stem Cells Americans Go Abroad for Banned Fertility Procedure Obesity Drug May Inhibit Prostate Cancer

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

Consumer Group Sues FDA Over Antidepressant

The consumer advocacy group Public Citizen sued the U.S. Food and Drug Administration on Monday for failing to act on a Public Citizen petition, filed more than a year ago, that sought a ban of the antidepressant drug nefazodone.

The suit, filed in the U.S. District Court for the District of Columbia, asks the court to find the FDA's delay illegal and to require the agency to act.

Nefazodone, sold by Bristol-Myers Squibb under the brand name Serzone, can lead to liver failure, even death, the consumer group says. The FDA's slow decision process continues to put patients at risk of death or serious injury, according to the lawsuit.

Public Citizen sought a ban on nefazodone in March 2003, citing 21 cases of liver failure and 11 deaths between 1994, when the drug was first marketed, and the spring of 2002. An additional petition, submitted to the FDA in October 2003, included an analysis of the agency's Adverse Event Reports Database. That analysis showed that from April 1, 2002, through May 12, 2003, there were 33 additional reports of liver failure -- including nine deaths -- for a total of 54 patients with liver failure, including 20 deaths.

Nefazodone has already been taken off the market in Canada and Europe and is scheduled to be removed from the market in Australia and New Zealand in May, Public Citizen says. Since January 2002, a "black box" warning has been included in its U.S. packing insert, warning of life-threatening liver damage and recommending that physicians advise patients to be aware of signs of liver problems, the lawsuit says.


Feds to Start Counting Carbs

Stroll down any supermarket these days and you'll find low-carb orange juice, cereals, even low-carb ice cream. It's all part of the food industry's response to America's love affair with the Atkins diet and its assorted cousins.

But the problem, according to the Associated Press, is that many food manufacturers count carbohydrates in different ways. Some foods really do contain a reduced number of carbs, while others may possess just one gram less per serving than normal.

To help consumers make sense of it all, the U.S. Food and Drug Administration says it's preparing guidelines that will spell out just how many carbohydrates a food can contain so it can be labeled low- or reduced-carb, the news agency says.

It's an effort to "demystify the current confusion about carbohydrates," says FDA Deputy Commissioner Lester Crawford, who notes that a substantial number of products will probably have to change their labels as a result, the AP says.

The guidelines are expected some time this summer.


Many Blood Pressure Patients Unaware of Health Risks: Survey

Many patients with high blood pressure have a false sense of security about their health, says a survey of 800 people released Monday by the Massachusetts-based Rippe Lifestyle Institute.

According to the survey:

  • 76 percent of respondents with a blood pressure of 160/100 millimeters of mercury (mm Hg) said their doctors had not warned them their blood pressure was well above an acceptable level.
  • All study participants were on medication, 75 percent checked their pressure outside the doctor's office, but 47 percent still had high blood pressure.

A person with blood pressure of 160/100 mm Hg or above has four times the risk of heart attack or stroke than someone with a blood pressure of less than 120/80 mm Hg, according to new federal guidelines.

"People in this study don't understand that blood pressure is much more than just a number -- it is a measure of a person's risk of heart attack and stroke," says Dr. James M. Rippe, founder and director of the institute and associate professor of medicine at Tufts University School of Medicine. "We need to do more than tell people to take their medication and check their blood pressure. We have to teach them what their blood pressure means and how to lower it successfully."


Baldness Remedy May Lie in Stem Cells

Scientists have figured out how to use stem cells to make bald mice grow hair, which they say could ultimately lead to a similar treatment for people.

University of Pennsylvania researchers, reporting in the April issue of the journal Nature Biotechnology, say they used so-called "blank-slate" stem cells. This type of stem cell differs from embryonic cells -- harvested from live human embryos that are destroyed in the process -- that have sparked a political debate in the United States.

In this experiment, by contrast, "blank-slate" stem cells were taken from the hair follicles of other adult mice and implanted into the bald mice, the Associated Press reports. The study appears to confirm what scientists had suspected for years -- that the "blank-slate" stem cells give most people a full head of hair for life, the wire service says.

About $1 billion a year is spent in the United States combating baldness, the AP reports. But even with their latest research, a cure for people may still be several years away, the scientists caution.


Americans Go Abroad for Banned Fertility Procedure

An experimental fertility procedure in which part of one woman's egg is implanted into another is banned in the United States, forcing infertile couples who want to try the treatment to travel overseas, CNN reports.

Cytoplasmic transfer involves taking the cytoplasm -- a jelly-like substance that holds a cell's contents -- from a healthy donor egg and implanting it into an infertile woman's egg. The donor portion gives the egg the properties it needs to survive, but doesn't determine any physical traits, CNN reports.

Some doctors expressed concern that three pieces of human DNA in one embryo could cause birth defects, leading to a U.S. government ban of the procedure in 2001. While many U.S. fertility experts say the ramifications of the treatment remain a mystery, others say openly that they've tried it in countries where it's still legal.

The network cites fertility specialist Dr. Michael Fakih, who says he's delivered seven healthy babies from the procedure. The report didn't specify how many times Fakih had attempted the treatment.

CNN cited a couple who wanted a second child after previously conceiving a healthy baby by the treatment in the United States before the ban. The couple reportedly spent $10,000 to try again, this time at Fakih's clinic in Lebanon. The second attempt proved unsuccessful.


Obesity Drug May Inhibit Prostate Cancer

The anti-obesity drug Xenical (orlistat) appears to inhibit the growth of cancerous prostate tumors, according to researchers at the Burnham Institute in La Jolla, Calif.

Prostate cancer cells appear to be spurred by fatty acid synthase, an enzyme that converts dietary carbohydrates to fat, the scientists say. Xenical inhibits production of fatty acid synthase, and also appears to inhibit tumor growth in lab mice. Additional experiments found that the drug had no detectable effects on normal prostate cells and no apparent side effects, according to a media statement provided by the nonprofit institute.

Preliminary research indicates the drug may have a similar role in preventing cancers of the breast and colon.

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