Although there are more than 500 cases of mostly minor side effects involving a vaccine that could prevent cervical cancer in girls and women, U.S. health officials say there's no need for additional warning labels on the vaccine, the Associated Press reported Thursday.
The report preceded a meeting in Atlanta Thursday, at which experts were to present side-effects data on the vaccine, Gardasil, to the U.S. Centers for Disease Control and Prevention.
Many of the side-effect reports involve fainting, but fainting is a common side effect among teens who get any vaccination, experts told the wire service. "There is absolutely no reason to think that there is anything in this vaccine, as opposed to another vaccine, that's going to make people more likely to faint," CDC immunization safety official Dr. John Iskander told the AP.
Gardasil is Merck & Co.'s three-dose vaccine approved for females ages nine to 26. It protects against strains of the human papilloma virus (HPV) that have been shown to cause cancer of the cervix.
On Wednesday, a Virginia-based group called the National Vaccine Information Center issued a statement describing side effects of the vaccine. The statement also argued that not enough research had been done on the vaccine to prove that it was safe.
The AP said it had obtained data showing 542 reports of adverse side effects of the vaccine, ranging from fainting and injection site swelling, to fever and nausea. There also have been three reports of Guillian-Barre syndrome, a debilitating condition that has been associated with other vaccines, the wire service said.
Earlier this week, Merck said it would end a campaign to persuade states to require the vaccine for adolescent girls attending public school, the AP said.
More Americans Treated for Meth, Narcotic Abuse
While treatment admissions are falling for abuse of cocaine and heroin, admissions are rising for Americans being treated for abuse of methamphetamine and narcotic painkillers, the U.S. government said Thursday.
People treated for prescription narcotic abuse rose 9 percent to more than 64,000 between 2004 and 2005, the Substance Abuse and Mental Health Services Administration (SAMHSA) said in a statement. And between 1995 and 2005, the number of admissions for drugs including codeine, hydrocodone, morphine, oxycodone, and similar medications soared more than 300 percent, the agency said.
Use of methamphetamine, a home-made stimulant produced from ingredients in over-the-counter cold medicines, rose 12 percent to more than 169,000 between 2004 and 2005, SAMHSA said. But that number was relatively small compared with other illicit drugs, the agency added.
In 2005, there were 256,491 substance abuse treatment admissions for cocaine use and 254,345 admissions for heroin, representing slight declines from the prior year. Treatment for marijuana abuse also fell slightly over the span, the agency said.
Medical Marijuana Advocates Sue U.S. Government
U.S. advocates for legalizing use of marijuana for medicinal purposes have sued the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), charging both have issued "false and misleading statements" about the drug's medical benefits.
A non-profit group called Americans for Safe Access, based in Oakland, Calif., challenged the government agencies' contention that marijuana "has no currently accepted medical use in treatment in the United States," The New York Times reported Thursday.
The group's attorney, Joseph Elford, cited a recent study by the Clinical Research Center at San Francisco General Hospital, which found that smoking marijuana relieved pain and eased other symptoms of HIV, the virus that causes AIDS. That study was sanctioned by the FDA, Elford told the newspaper.
An HHS spokeswoman refused comment, saying the agency didn't issue statements on pending litigation. But she did say that the government stood by its statement of April 2006, in which it said "there is currently sound evidence that smoked marijuana is harmful."
European Union Not Ready for Flu Pandemic: Report
The European Union is ill-prepared for the long-feared human flu pandemic that could arise from the current outbreak of H5N1 bird flu, the European Center for Disease Control said in a report released Thursday.
The EU is at least two years away from being able to respond effectively to a massive human flu outbreak, according to a Bloomberg news service report of the agency's findings.
The current strain of H5N1 emerged in Asia in 2003. World health officials fear the deadly virus, which has led to the deaths and slaughter of millions of birds and has killed at least 167 people, could mutate into a pandemic form that's easily passed between humans.
"It's a question of 'when', not 'if" a [human] pandemic will occur," ECDC Director Zsuzsanna Jakab said in the report. The analysis urged governments to be better prepared in non-health related sectors such as electric utilities, which must devise plans to deal with significant staff absenteeism, Bloomberg reported.
Diabetes Drug Linked to Fractures in Females
The U.S. Food and Drug Administration issued a safety alert Wednesday on drug maker GlaxoSmithKline warning doctors that long-term use of its diabetes drug Avandia (rosiglitazone) has been linked to an increased incidence of fractures in females.
The company outlined the results of a safety review of a large-scale study involving 4,360 patients with recently diagnosed type 2 diabetes mellitus. The review found that female Avandia users experienced more fractures of the upper arm, hand, or foot than did female patients who received the two other medications in the study, metformin and glyburide. The incidence of fractures in male users was similar in all three drugs.
The company is advising doctors to consider the risk of fractures when prescribing Avandia to female patients.
And, according to MarketWatch, a spokesman for Glaxo said the company was in talks with European Union regulators about sending a similar letter to European doctors.
U.S. Stillbirths Decline, Racial Disparities Persist: Study
Stillbirths in the United States declined significantly between 1990 and 2003, but the fetal mortality rate for non-Hispanic black women was more than double that of non-Hispanic white women, a new report released Wednesday by the U.S. Centers for Disease Control and Prevention(CDC) shows.
The study, "Fetal and Perinatal Mortality, United States: 2003," looked at fetal deaths among all racial and ethnic groups occurring at 20 weeks of gestation or more. The fetal mortality rate for non-Hispanic black women was 11.56 per 1,000, compared to 4.94 per 1,000 for non-Hispanic white women. "While we can see that progress has been made in preventing fetal mortality, it is also clear that substantial disparities remain along race and ethnic lines, " said the study's lead author, Marian MacDorman, senior social scientist in the Division of Vital Statistics at the CDC's National Center for Health Statistics.
Among other findings in the report:
The number of fetal deaths per 1,000 live births declined an average of 1.4 percent a year from 1990-2003.
The decline since 1990 occurred among pregnancies 28 weeks of gestation and longer, while the fetal death rate for pregnancies 20-27 weeks of gestation has changed little since 1990.
American Indian women had a fetal death rate of 6.09 per 1,000 live births -- 24 percent higher than that for non-Hispanic white women. For Hispanic women, the rate was slightly higher than that for non-Hispanic white women (5.46 per 1,000), and the rate for Asian or Pacific Islander women was similar to that of non-Hispanic white women (4.98 per 1,000).