Health Highlights: April 23, 2002
FDA Approves Burn Scar Repair Product Panel to Urge FDA to Reintroduce Bowel Drug Feds' Policies Make Vision Vitamin's Message Fuzzy Traffic Deaths at Historic Lows, DOT Says WHO Adds AIDS Drugs to List of Essential Medications Dental Lab Workers Prone to Toxic Metal Poisoning
Here are some of the latest health and medical news developments, compiled by editors of The HealthDay Service:
FDA Approves Burn Scar Repair Product
A product designed to help in the healing of scars in severe burn cases received approval from the Food and Drug Administration today, reports the Associated Press.
The product, called the Integra Regeneration Template, consists of two layers of membrane with a synthetic tissue on the outside and a cross-linked layer of collagen fibers on the inside.
On scars, damaged tissue is removed and is replaced with the template, which facilitates in the re-growth of blood vessels and other cells into a new layer of skin.
The template would typically stay on for about two or three weeks, after which time the layer is removed and is replaced with a graft of the patient's skin.
The product is made by Integra LifeSciences Corp., of Plainsboro, N.J.
FDA Urged to Reintroduce Bowel Drug
Government advisers heeded patients' pleas today that a drug for irritable bowel syndrome should be cleared for sale again -- but with stringent restrictions to try to mitigate side effects that have hospitalized more than 160 people and killed seven.
If the Food and Drug Administration heeds the panel's advice, Lotronex will be tough to get -- prescribed only by doctors who have undergone special training to use it and given only to the sickest patients, who must register in a national database that monitors how well they fare, according to the Associated Press.
To patients who called the drug a miracle therapy, that's enough. ``A life without Lotronex is a miserable existence,'' said a tearful Diana Hoyt of Atlanta, who described swallowing four anti-diarrheal pills and donning a diaper just to spend a few minutes asking the FDA for the only pill that ever made her feel well.
Two attorneys for people injured by the once-popular drug, which was pulled off the market in November 2000, argued before the panel that it's too risky to sell again. One played a video of a Florida woman left mostly paralyzed and unable to breathe on her own after a burst colon attributed to Lotronex caused a brain-damaging infection.
Feds' Policies Make Vision Vitamin's Message Fuzzy
The ambitious claims of the effectiveness of a so-called "eye vitamin" made by vision care company Bausch & Lomb are anything but clear and blur the lines of Food and Drug Administration marketing policies, reports the Washington Post.
The supplement, called PreserVision, is a mix of vitamins such as zinc, beta carotene and other vitamins. The combination has indeed been found in studies to significantly reduce permanent vision loss for some people with age-related macular degeneration.
But the research did not find that the mix prevented the progression of macular degeneration for patients in the beginning stages of the disease, nor was it shown to be helpful in preventing cataracts, another age-related eye disease, say experts.
In fact, experts say, no food or dietary supplement has ever been shown to improve vision.
But since the product is indeed a dietary supplement and not a drug, Bausch & Lomb is prevented from clarifying what the product can specifically treat, because products that claim to work as treatment for any specific disease are considered drugs and must receive FDA approval.
Since the marketing claims cannot be made clear, experts worry that people with early stages of macular degeneration, as well as younger people simply looking to prevent their eyes from failing with age, may be convinced to use the product when such usage is not advised, says the Post.
Traffic Deaths at Historic Lows, DOT Says
Traffic deaths fell to all-time lows in 2001, including deaths of children ages 15 and under, the federal Department of Transportation says.
Still, 41,730 people died in highway crashes last year, compared to 41,821 in 2000. Three million people were injured in accidents in 2001, down from 3.2 million a year earlier. The department stresses that 60 percent of those killed in crashes last year were not wearing seat belts.
The number of deaths among children under five dropped 5.4 percent to 668 in 2001 from 706 in 2000. Traffic fatalities for children ages five to 15 dropped 5.5 percent to 1,990 from 2,105 in 2000.
Additional findings from the DOT's report:
- Motorcycle deaths rose for the fourth straight year to 3,067 in 2001, the highest number of motorcycle fatalities since 1990.
- The percentage of alcohol-related deaths in 2001 remained unchanged at 40 percent, accounting for 16,652 deaths.
- Deaths involving large truck crashes dropped to 5,192 in 2001 from 5,211 in 2000.
- Drivers ages 16 to 20 were involved in 7,547 fatal crashes in 2001, compared to 7,607 in 2000.
WHO Adds AIDS Drugs to List of Essential Medications
The World Health Organization has added 10 state-of-the-art antiviral drugs to its 316-item list of essential medications for nations around the world, the Washington Post reports.
The list is aimed at non-European, non-North American nations, which account for a whopping 38.4 million of the world's 40 million AIDS cases. It includes the so-called "triple cocktail" of AIDS drugs, which has dramatically extended the lives of AIDS patients in developed nations.
But because the drugs are now included on the WHO's list doesn't mean that they'll actually get to those who need them, the Post says. The triple cocktail usually costs more than $8,000 annually in the United States, but can be obtained for less than $1,000 in poorer nations. That's still far beyond what many Third World nations can afford.
Of the 28 million people infected with the AIDS virus in sub-Saharan Africa, fewer than 1 percent are on the triple therapy, the newspaper says.
Dental Lab Workers Prone to Toxic Metal Poisoning
Dental lab workers who work on crowns, bridges or dental frames are prone to inhaling dust laden with the toxic metal beryllium, the Occupational Safety and Health Administration says.
Today's OSHA warning is prompted by the diagnosis of chronic beryllium disease in an unnamed dental lab technician, reports the Associated Press. The lung disease -- including symptoms of dry cough, shortness of breath, fatigue, weight loss and fever -- is debilitating and often fatal. It can show up months or years after exposure.
OSHA's current regulations -- which the agency says it's now reviewing -- specify that workers can't be exposed to more than 2 micrograms of beryllium per cubic meter of air. Not all metals used in dental work contain beryllium, and lab workers should ask about the contents of the alloys they are using, OSHA says.