Health Highlights: May 8, 2004
Critics Hit FDA Action on Morning-After Pill NYC Sues OxyContin Manufacturer Cruise Ship Passengers Stricken by Norovirus Near-Retirees Who Lose Job Twice as Likely to Suffer Stroke Latest Angioplasty Warning: Radiation Burns FDA to Examine Effects of Furan Found in Food
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
Critics Hit FDA Action on Morning-After Pill
The U.S. Food and Drug Administration has added a new hurdle before allowing a controversial emergency contraceptive to be sold on a nonprescription basis, but denied allegations the move was politically motivated, HealthDay reported.
The pill in question is levonorgestrel, better known as Plan B or the "morning after" pill. On Thursday, the FDA informed the pill's maker that it can't be sold over the counter until more studies are done.
Critics said the latest action of the FDA, which ignores the advice of two expert advisory committees and the agency's own staff, was a triumph of politics over science. The American College of Obstetricians and Gynecologists went so far as to call it "morally repugnant," a "tragedy for American women, and a dark stain" on the agency's reputation.
The move ostensibly arose from concern that young teenagers would not be able to use the product safely. "We based our action primarily on the lack of data concerning use of this product among adolescents younger than 16," Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research (CDER), said at a press conference Friday. "The sponsors didn't contain any data on those under 14 and limited data on those 14 to 16."
NYC Sues OxyContin Manufacturer
New York City is suing the manufacturer of OxyContin, charging the company cost it millions of dollars in Medicaid payments by blocking a generic version of the popular painkiller.
The lawsuit, filed Friday in federal court against Stamford, Conn.-based Purdue Pharma, alleges the city would have saved money on a less expensive, generic alternative. New York pays 25 percent of elderly and poor residents' Medicaid costs, the Associated Press reported.
The lawsuit seeks damages equaling three times the amount the city lost by not using a generic brand. City officials said it cost $5.5 million to provide OxyContin to residents in 2002 and they are still calculating losses from using the brand name rather than a generic product.
A federal court ruling in January found that Purdue Pharma deliberately misled the U.S. Patent Office when it sought to protect its patents for the popular painkiller. The ruling would lead the way for the manufacture of generic brands, but Purdue Pharma has appealed.
Officials with the company could not be reached for comment Saturday.
Cruise Ship Passengers Stricken by Norovirus
A cruise ship returned to Sydney, Australia, Saturday with 140 of its passengers apparently stricken by a stomach virus.
P&O, which operates the Pacific Sky cruiseliner, said it would consider refunds or credits for future cruises on a case-by-case basis following the outbreak of norovirus during the 11-day trip. But it also appeared to blame the passengers themselves for the outbreak.
"Some passengers, when they're on holiday, are not as vigilant as we would like in terms of personal hygiene," P&O Cruises spokesman Gavin Smith said according to an Associated Press report.
It was not immediately clear how many passengers were on board or if the cruise was cut short. The Pacific Sky, which can carry 1,550 passengers, was scrubbed down Saturday before it set off on a new cruise.
Noroviruses -- which includes Norwalk and Norwalk-like viruses -- are spread through food and water and through close contact with infected people. They can cause diarrhea, stomach pain and vomiting for 24 to 48 hours. Thousands of cruise passengers have fallen ill with the disease in recent years.
Near-Retirees Who Lose Job Twice as Likely to Suffer Stroke
People nearest to retirement who get laid off or fired have double the stroke risk of colleagues who have kept their jobs, a new study says.
The research team, led by Yale University epidemiologist William Gallo, was able to make the association between losing one's job and having a stroke. Interestingly, however, the same risk was not found for having a heart attack under the same circumstances.
According to a news release from the Yale School of Medicine, the basis of the study was six years of data from a national Health and Retirement Survey, which identified 457 workers who were either laid off or left jobless because of a plant shutdown. These individuals were compared to a group of 3,763 older persons who were still employed. All of the participants were born between 1931 and 1941.
Why stroke risk increases while heart attack risk does not requires further study, Gallo said. "With longer follow-up, we will be able to more definitively assess the relationship between unemployment and stroke," he added.
Latest Angioplasty Warning: Radiation Burns
The latest alert about angioplasty has nothing to do with clogged arteries.
According to the Associated Press, X-rays used during angioplasty can cause severe skin burns, and one of the primary reasons is because cardiologists haven't received sufficient training on minimizing radiation exposure.
Experts from the U.N. International Atomic Energy Agency explained the problem during a two-day meeting in Vienna, and while experts said the radiation risk was evident, the advantages of angioplasty still far outweighed the possible danger.
Angioplasty is a procedure that opens clogged arteries without performing major surgery. A catheter attached to a balloon is threaded through the blood vessels to open a blocked artery by squeezing the plaque against the walls. Physicians often use fluoroscopy, a technique that provides live X-ray images, to guide the catheter insertion.
According to the wire service, because radiation used in fluoroscopy is much stronger than normal X-rays, a small number of patients suffer skin damage. Some could later develop cancer because of the exposure, said one expert, and that's why further training is necessary.
FDA to Examine Effects of Furan Found in Food
Furan is a naturally occurring substance found in pine trees and other plants. Its derivative is also manufactured as a pesticide.
The U.S. Food and Drug Administration said it was going to assess the possible carcinogenic possibilities of food that may contain very low levels of furan.
While not naming specific foods, the FDA said: "Some animal data suggests that high levels of furan exposure might have a carcinogenic effect in humans, but its true effects in humans - especially at such very low levels -- are not known.
"A new method developed by FDA scientists has revealed that very low levels of furan are found in a wider range of foods than previously suspected. FDA scientists discovered that furan forms in a variety of foods that undergo heat treatment, including certain canned and jarred foods. FDA tested a variety of foods and the results ranged from non-detectable levels in some foods to approximately 100 parts per billion in other foods."
The agency hasn't yet determined how long the testing will take. After an advisory committee meeting, the FDA will decide on a number of possible next steps, including, its statement said, "an expanded food survey, studies to address how furan forms in foods, potential strategies to reduce furan levels, and toxicology studies to address mechanisms of toxicity and dose response."