Health Highlights: Aug. 9, 2003
California to Ban Flame-Retardant Chemicals FDA Cracks Down on Ads for Cholesterol Drug S. Africa to Offer HIV Drug Plan 2003 Could be Worst Year Yet for West Nile Unpublished Paxil Studies Prompt Teenage Suicide Concern
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
California to Ban Flame-Retardant Chemicals
California will become the first state in the nation to ban two forms of flame-retardant chemicals known to accumulate in the blood of mothers and nursing babies.
The legislation was headed for signing by Gov. Gray Davis, but the ban doesn't take effect until Jan. 1, 2008, the Associated Press reports. Manufacturers have said they need the time to find alternatives to the chemicals, known as PBDEs and commonly used to coat furniture, electronics, plastic and foam products.
Studies show North American women have the highest levels of the chemicals in the world, nearing levels shown to damage memory, behavior and learning in laboratory mice.
California researchers found Bay Area women have three to 10 times greater amounts of the chemical in their breast tissue than either European or Japanese women, the AP reports. Indiana University researchers found levels in Indiana and California women and infants 20 times higher than in Sweden and Norway.
The chemicals remain in the environment for years and build up in the body over a lifetime, similar to PCBs and DDT, which was banned decades ago in the United States.
FDA Cracks Down on Cholesterol Drug Ads
The government has ordered the maker of the popular anti-cholesterol drug Pravachol to air corrections after overstating the drug's benefits in ads to both consumers and doctors.
The Food and Drug Administration order is considered an unusually tough move that signals more scrutiny of how truthful drug companies are about their products.
FDA Commissioner Mark McClellan highlighted the order to Pravachol maker Bristol-Myers Squibb Co. in a speech Friday that was designed to put the industry on notice that the agency is getting tougher with lawbreakers, the Associated Press.
For Pravachol, one of the top-selling anti-cholesterol medicines, the FDA complained that ads in major newspapers and magazines give consumers the impression that the drug is the lone treatment for preventing strokes. It's not, and it only reduces the risk of strokes in people who already have heart disease, the FDA said.
Also on Friday, the FDA ordered another company, Gilead Sciences, to stop downplaying the risks of its anti-HIV drug Viread at AIDS meetings -- and to stop its salesmen from calling Viread a "miracle drug.'' The letter marked the FDA's second warning about the drug's promotion.
S. Africa to Offer HIV Drug Plan
The South African government has dropped its long-standing resistance to providing drugs to combat the AIDS virus, and is preparing a drug plan to offer to infected people through its public health system by Oct. 1.
The decision came after the South African cabinet held a special meeting Friday to assess the financial costs of a national anti-HIV drug plan and to explore options for treating those with the infection, The New York Times reports.
South Africa has the largest number of HIV-infected people in the world, about 5 million, or more than 11 percent of its 43.8 million population, according to the United Nations AIDS program. The infection rate among its 23.7 million people aged 15 to 49 is even higher: about 20 percent of them are infected. So far, the epidemic has left 660,000 South African children as orphans.
The government said that because not every infected person needed anti-HIV drugs, known as antiretrovirals, its program would provide them initially to people with more advanced cases of AIDS. The program is also expected to provide prevention programs aimed at the tens of millions of people who are not infected.
The policy change comes in the same week that South Africa held its first AIDS conference, and just a month after President Bush pressed President Thabo Mbeki during his visit to Africa to come up with a plan that included both a drug regimen and prevention efforts.
2003 Shapes Up as Worst Year Yet for West Nile
The number of West Nile virus infections in the United States has tripled since last week. That means more people could be stricken with the disease this year than ever before, federal officials warn.
A total of 16 states have now reported a total of 153 human cases of infection. Colorado has been hit hardest, with 72 cases. Texas follows with 19 and Louisiana with 15, HealthDay reports.
Federal health officials have officially confirmed four deaths, but these reports typically lag those of state health departments. Colorado officials have reported four deaths, for instance.
At this time last year, there were 112 cases of West Nile in four states, with Louisiana leading the pack. Colorado had no cases.
"We are starting the epidemic with more cases and more areas affected, and if the same pattern holds true, we may be seeing an even greater number of affected people," Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention, said at a news briefing Thursday.
Unpublished Paxil Studies Prompt Concern Over Teenage Suicide
Prescribing anti-depressants to teenagers may have the opposite effect in some cases, and this revelation has caused scientists to re-examine how drugs like Paxil, Zoloft and Prozac are used.
The New York Times reports that "unpublished studies about Paxil show that it carries a substantial risk of prompting teenagers and children to consider suicide."
This was first revealed in a British study last year, which led the U.S. Food and Drug Administration to consider re-examining the use of these drugs by teens, the Times reports.
U.S. regulators are recommending that no person under age 18 be given an anti-depressant. The recommendation is based on a finding that placebos seemed to be just as effective as the anti-depressants -- also known as selective serotonin reuptake inhibitors (SSRIs) -- in treating depression in young people. Experts say that the suicide risk is highest in the first few weeks teenage patients are on the drug.
Where are the unpublished reports? According to the Times: "GlaxoSmithKline (which makes Paxil), for instance, has acknowledged that just one of its nine studies of Paxil in children and adolescents has been published, a study that made only passing mention of suicide and concluded that the drug was effective against depression. According to the F.D.A., the combined results of all nine trials show that the drug is not effective against depression in patients under 18."
However, everyone involved in taking another look at SSRIs acknowledges their value in fighting depression in adults.