Health Highlights: May 17, 2006
Five More Bird Flu Deaths in Indonesia FDA Documents Reveal Concerns About HPV Vaccine Stress During Pregnancy May Benefit Babies Debate Rises Over RU-486 Abortion Pill Company Failed to Give FDA Prompt Notice About Eye Infections
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
Five More Bird Flu Deaths in Indonesia
Five more people in Indonesia have died from bird flu and there are conflicting reports about the possibility of human-to-human transmission of the disease, BBC News reported.
Four of the five victims were from the same family and one Indonesian agriculture official said the possibility of human-to-human transmission of the H5N1 virus in those cases could still not be ruled out.
However, a health ministry spokesman said the disease spread to the victims from poultry or other animals and there is no proof of human-to-human transmission.
The four family members lived in northern Sumatra and up to eight members of the family could be involved. Tests are being conducted to determine if the sick relatives of the dead people are infected with H5N1, BBC News reported.
The fifth death occurred in East Java.
The deaths bring to 30 the number of people in Indonesia who have been killed by bird flu so far this year, the most deaths of any country this year. Since 2003, bird flu has killed 115 worldwide and devastated poultry stocks. So far, all human infections are believed to have been due to direct contact with sick poultry.
FDA Documents Reveal Concerns About HPV Vaccine
Gardasil, a vaccine designed to block infection by four types of human papilloma virus (HPV) that cause most cervical cancers and genital warts, may actually increase the risk of disease in some patients, according to U.S. Food and Drug Administration documents released Wednesday.
The briefing documents were released in advance of a meeting Thursday at which an outside panel of experts will discuss whether to recommend approving the use of Gardasil. The FDA's decision is expected by June 8, the Associated Press reported.
The agency documents reveal that an FDA review of studies of the vaccine suggest it is safe and effective, but the agency did identify two important concerns.
The first concern is that Gardasil may result in an increased number of cases of a cancer precursor among patients who are already infected by one of the four targeted HPV types when they're given the vaccine; and whose immune systems haven't eliminated the virus from their bodies, the AP reported.
Secondly, any advantage provided by the vaccine in protecting against the four targeted HPV types could be offset by infection by the numerous other HPV types that aren't affected by the vaccine.
The briefing documents also requested that the expert panel examine five cases in which women who received the vaccine around the time of conception gave birth to children with birth defects.
HPV is the most common sexually transmitted disease among females ages 9 to 26. About 80 percent of young women are infected with HPV five years after they become sexually active. In most women, the immune system clears the virus. But, if HPV remains in the body, there's an 800-fold increased risk of cervical cancer or precancerous lesions.
Each year, cervical cancer kills about 3,500 women in the United States.
Tests found that Gardasil, made by Merck & Co., is nearly 100 percent effective against HPV and works for at least five years, the AP reported. Up to two-thirds of cervical cancers could be prevented if the vaccine were widely used, experts estimate. However, that reduction would not be seen for many years, because cervical cancer can take two decades to develop.
Gardasil requires three shots over six months at an estimated total cost of $300 to $500, the AP reported.
Stress During Pregnancy May Benefit Babies
Pregnant women don't need to worry about being worried -- a bit of stress may actually be good for their child, suggests a study by researchers at Johns Hopkins Bloomberg School of Public Health in Baltimore.
The study of 137 women with normal, low-risk pregnancies concluded that those who reported moderate stress between the 24th and 32nd weeks of pregnancy had children who were more advanced at age 2 than other children, BBC News reported.
The researchers said they expected to find that stress during pregnancy would be associated with bad behavior and temperamental dysfunction when the women's children were 2 years old. Instead, they found the reverse was true.
There may be two possible explanations. Pregnant women experiencing stress may produce higher levels of the stress hormone cortisol, which "could be enhancing the development of organs before birth," said study author and developmental psychologist Janet DiPietro.
She also said the women who have higher stress levels are those who challenge themselves and challenge their babies after birth, which prompts faster development.
The study appears in the journal Child Development.
Debate Rises Over RU-486 Abortion Pill
Opponents of the RU-486 (Mifeprex) abortion drug contend it's dangerous to women and want the U.S. Food and Drug Administration to take the drug off the market.
Those leading the campaign against the drug point to the deaths in recent years of four to eight young women who took the drug, particularly four deaths from the bacterium Clostridium sordelli, the Washington Post reported.
As part of the debate over RU-486, the U.S. House Government Reform subcommittee on Criminal Justice is scheduled to hold a meeting Wednesday into the supposed dangers of the drug.
"Considering the evidence we have of deaths and serious side effects, the maker of this drug should have taken it off the market long ago," Michelle Gress, counsel to the subcommittee and spokeswoman for subcommittee chairman Rep. Mark Edward Souder, R-Ind., told the Post.
However, experts at the FDA and the federal Centers for Disease Control and Prevention have linked the clostridium bacterium to the deaths of more than a dozen women after childbirth or miscarriage. This makes it unclear whether there is a direct association between RU-486 and Clostridium sordelli.
"We think it's premature to say there is a direct relationship between (RU-486) and these (four) clostridium deaths. The situation is far more complicated than we originally imagined, and far more broad than anything limited to this drug," Sandra Kweder, deputy director of the FDA's Office of New Drugs, told the Post.
Company Failed to Give FDA Prompt Notice About Eye Infections
U.S. eye-care products maker Bausch & Lomb did not promptly notify the federal Food and Drug Administration about 35 cases of dangerous fungal eye infections among people in Singapore who used the company's ReNu with MoistureLoc contact lens solution.
The company's failure to notify the FDA about the Singapore infections within 30 days was one of 20 potential violations noted by the FDA after inspecting the Bausch & Lomb factory in Greenville, S.C., the Associated Press reported.
The Greenville plant made ReNu with MoistureLoc for sale in the United States and several Asian countries. The contact lens solution was removed from markets worldwide Monday. It's been linked to potentially blinding Fusarium keratitis infections in Asia and the United States.
The FDA also noted that Bausch & Lomb failed to notify the agency in writing that the company had removed ReNu with MoistureLoc from the Singapore and Hong Kong markets in February.