Health Highlights: April 3, 2009
CDC Finds Rocket Fuel Chemical in U.S. Baby Formula FDA Panel Splits on New Diabetes Drug Childhood Cancer Survivors Face Learning Problems: Study
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
CDC Finds Rocket Fuel Chemical in U.S. Baby Formula
A rocket fuel chemical called perchlorate was found in samples of powdered baby formula tested by U.S. Centers for Disease Control and Prevention scientists, but it's not clear how much of a health threat it poses to infants.
The largest amounts of perchlorate were found in baby formula derived from cow's milk, said the researchers, who wouldn't disclose the brands of formula they analyzed, the Associated Press reported.
Scientists have said significant amounts of perchlorate can affect the function of the thyroid, which helps set the body's metabolism. Fetal and infant brain development can be affected by thyroid problems.
But the level of risk posed by the trace amounts of perchlorate in baby formula is difficult to assess, the AP reported. Formula sold in the United States must contain iodine, which counteracts perchlorate's effects. Other factors that influence risk include the infant's size and how much formula they consume.
Potential health risks weren't examined in the CDC study, which was published last month. The Environmental Working Group issued a press release Thursday to draw public attention to the study.
FDA Panel Splits on New Diabetes Drug
A U.S. Food and Drug Administration advisory panel has found that an experimental diabetes drug from Novo Nordisk does not appear to carry heart risks, but panel members were split on whether to recommend approval for the injectable medication because of its possible link to thyroid tumors.
The Danish drug maker has asked the FDA to approve liraglutide for millions of patients with type 2 diabetes. The drug has been shown to lower blood sugar levels while reducing weight, making it unique among diabetes medications.
According to the Associated Press, the panelists voted 6 to 6 on whether the drug should be approved, because research has shown it caused cancerous thyroid tumors in rats and mice. The panel voted 8 to 5 that liraglutide did not appear to hasten heart attack and other problems seen with similar drugs in recent years.
The FDA is not required to follow its advisory panels' advice, though it usually does.
Denmark-based Novo Nordisk is one of more than a dozen companies developing new therapies to compete in the $5.1 billion U.S. diabetes drug market, the wire service reported.
FDA scientists stressed that most drug studies are discontinued after showing findings similar to the rat and mice studies conducted with liraglutide.
"It is very rare for a drug that has caused tumors in two species, in both genders at clinically relevant exposures, to be approved," said FDA drug reviewer Karen Mahoney. Novo Nordisk argued that while their drug spurs tumor growth in rodent cells, there is no comparable reaction in humans. But that reasoning failed to convince a majority of panelists.
"I just don't think we have enough data to be reasonably confident of safety in humans for long-term use," said Dr. Peter Savage, of the U.S. National Institutes of Health.
Liraglutide is among the first to go before the FDA's panel of diabetes experts since the agency issued new safety guidelines for diabetes treatments last year. The more cautious stance followed a 2007 controversy surrounding figures suggesting GlaxoSmithKline's blockbuster pill Avandia increased the risk of heart attack.
Because Novo Nordisk conducted its tests before the FDA issued the new guidelines, it primarily studied the drug in otherwise healthy diabetes patients in their 50s, excluding patients with elevated heart risks, the wire service reported. The FDA now requires companies to study high-risk patients, including the elderly, to give a more complete picture of the drug's side effects.
If approved, Novo Nordisk plans to the market the drug under the name Victoza. A decision is expected in the coming weeks, according to the AP.
Childhood Cancer Survivors Face Learning Problems: Study
Many children who survive cancer experience learning problems and poor educational achievement, according to a Canadian study.
It included almost 800 people who had a primary diagnosis of cancer at age 15 or younger and had survived for more than five years after the diagnosis. Compared to their peers, young cancer survivors needed more special education services, were more likely to repeat a grade level, and achieved lower levels of education, United Press International reported.
The study was published in the journal Cancer.
"These are very significant findings," Barbara Kaminsky, chief executive officer of the Canadian Cancer Society of British Columbia and Yukon, said in a news release, UPI reported. "It is not good enough to just improve survival rates for these children. We need to ensure that as many childhood cancer patients as possible become more than survivors -- rather we hope to have post-cancer thrivers."
Kaminsky said many childhood cancer survivors experience "adverse late effects" -- problems that may be related to the disease or to the aggressive treatments they've endured.