Health Highlights: Jan. 9, 2009
FDA Delays Decision on Gardasil Approval for Older Women Consumers Union Urges Expanded Testing of Infant Formula Racial, Ethnic Disparities Persist in Spina Bifida Births Salmonella Cases Still a Mystery Large Lab Admits Problems With Vitamin D Tests
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
FDA Delays Decision on Gardasil Approval for Older Women
The U.S. Food and Drug Administration has asked drug maker Merck & Co. for more information before it decides whether to expand approval for Gardasil, a human papillomavirus vaccine, Merck said Friday.
Gardasil is currently approved for females ages 9 to 26. Merck has asked the FDA to widen approval for its use in women aged 27 to 45, the Associated Press reported. The drug is designed to guard against HPV, which is responsible for most cases of cervical cancer.
The FDA wants additional data from an ongoing 48-month study of Gardasil, the wire service said. The agency's action does not affect currently approved uses, nor Merck's application to approve the drug for use in males ages 9 to 26.
The vaccine costs about $360 for the three required doses, and some experts have said it's not cost-effective for older women, the Dow Jones news service reported. A Harvard study funded by the U.S. government, published last year, found the vaccine was cost-effective for girls, but not for females in their 20s, the AP said.
Consumers Union Urges Expanded Testing of Infant Formula
Consumers Union urged the U.S. Food and Drug Administration on Friday to expand testing of infant formula for melamine and related compounds, and to recall all contaminated products.
The request came after the FDA published two new reports of contamination on its Web site over the holidays, doubling the number cases previously reported last November. The FDA deemed melamine levels in the new cases extremely minute and safe for babies. Traces of the industrial chemical melamine and a byproduct, cyanuric acid, have now been found in four of 89 containers of infant formula made in the United States, the Associated Press reported.
The two new cases involved containers of Mead Johnson's Enfamil LIPIL with Iron that had traces of cyanuric acid, a weak acid used as a chlorine stabilizer in swimming pools. Previous tests had found traces of melamine in a can of milk-based liquid Nestle Good Start Supreme Infant Formula with Iron. A third major formula maker, Abbott Laboratories, whose brands include Similac, told the AP in November that in-house tests had detected traces of melamine in its formula, but far below levels the FDA found in the other formulas.
Consumers Union called the FDA risk assessment from November 2008 "flawed," saying it ignored important scientific data. The FDA now says that up to one part per million of melamine in formula is safe. Levels in the new cases were well below that standard, but an agency risk assessment issued as recently as October 2008 had said that no amount of melamine in formula could be considered safe.
Melamine-tainted formula has sickened tens of thousands of children in China, killing at least six. The melamine was apparently added to milk powder by manufacturers to make their watered-down formulas appear more nutritious. The FDA has said that domestic supplies are safe, however, because U.S. formula makers do not obtain ingredients for their products from China.
Abbott Laboratories, Nestle and Mead Johnson make more than 90 percent of the infant formula produced in the United States, the AP said.
Racial, Ethnic Disparities Persist in Spina Bifida Births
Public health efforts to decrease the number of babies born with spina bifida should target women at higher risk, including those who are obese, of Hispanic ethnicity, or who carry certain genetic risk factors, according to a new review by the U.S. Centers for Disease Control and Prevention (CDC).
Spina bifida, a developmental birth defect of the neural tube, called an NTD-affected pregnancy, results in an infant's having an incompletely formed spinal cord. In January 1998, the U.S. Food and Drug Administration mandated adding folic acid to all enriched cereal grain products to reduce the risk. Prior to conception, women are now urged to take 400 micrograms of daily folic acid supplementation.
The new data showed no additional decrease in spina bifida among infants born to non-Hispanic white and Hispanic mothers since mandatory folic acid fortification was implemented, but a 20 percent decrease was registered among infants born to non-Hispanic black mothers, according to the CDC review, which looked at statistics from 1999 to 2005. The findings were published in the Jan. 9 issue of the CDC's Morbidity and Mortality Weekly Report.
"Future public health efforts to reduce the prevalence of spina bifida should focus on subgroups of women with known risk factors for an NTD-affected pregnancy, such as obesity, Hispanic ethnicity, and certain genetic factors. Additional study of genetic and environmental risk and protective factors is warranted," the CDC review said. "Future decreases in the prevalence of spina bifida might be attenuated as the percentage of NTDs preventable by consuming folic acid continues to diminish," the report added.
An estimated 50 percent to 70 percent of neural tube disorders can be prevented through daily consumption of 400 micrograms of folic acid, the study said.
Salmonella Cases Still a Mystery
Georgia, Ohio and Minnesota are among the 42 states now affected by the salmonella bacterium that has continued to sicken hundreds of Americans during the past three months with a reported 388 cases, the Associated Press said Thursday.
Georgia officials said they've identified five people who became ill from mid-October to mid-December. No one died, but at least one person was hospitalized. In Ohio, 51 people in 20 counties, where at least a dozen were hospitalized, had the same type of salmonella about the same time as the Georgia cases, health officials said.
A Minnesota health official said Thursday the state has had 30 cases, while in California, 51 cases had been reported as of last week, AP said.
USA Today also reported that officials from the U.S. Centers for Disease Control and Prevention (CDC) have become concerned enough about the latest incidences to form a task force to find the cause. The CDC is leading the investigation but has not yet released the full list of states or determined which foods may have caused the illnesses.
This can be a daunting task. For example, more than 1,400 people in the United States suffered from salmonella poisoning in 2008 before the source was found -- peppers imported from Mexico. And another 401 cases in 41 states were reported in November, caused by the bacterium in microwaveable pot pies.
Infectious disease specialists don't yet know the source of the current illnesses, if there is indeed a single source.
The CDC says salmonella symptoms include nausea, diarrhea, stomach cramps and fever, and it usually is spread by fecal matter coming in contact with food people eat, whether animal or vegetable.
Large Lab Admits Problems With Vitamin D Tests
Quest Diagnostics, the largest provider of medical laboratory tests in the United States, says it has fixed a problem that led to higher vitamin D readings for about 7 percent of patients from 2007 to 2008, the Associated Press reported Wednesday.
The Madison, N.J., lab said it noticed an "upward trend" in the vitamin D levels being registered on some of its tests during the summer, then offered free tests for patients whose results were called into question, according to Gary Samuels, the company's vice president for communications. Blood tests to check vitamin D levels are on the rise, because research has shown a possible link between too little "sunshine vitamin" and a higher risk for cancer and heart disease.
Quest's chief medical official, Dr. Wael Salameh, told AP that he doubted patients would have suffered any harm. People with serious vitamin D deficiency, he said, often exhibit physical symptoms such as fractures that doctors would have noticed. "A good doctor would question the test," Salameh added. "For the few vulnerable patients, other indicators would have flagged the situation to their physician."
Quest said the cause of the problem proved to be how some of the company's testing chemicals were mixed. But the company is using a new testing technology, AP reported, which critics say tends to produce higher vitamin D readings.