Health Highlights: Sept. 9, 2009

Here are some of the latest health and medical news developments, compiled by editors of HealthDay:

Poor Trial Results a Setback for First Stem Cell Drug

Prochymal, an experimental drug which its makers had hoped would be the first mass-produced medication derived from stem cells, has failed two late-stage clinical trials, the New York Times reported Wednesday.

The drug is derived from mesenchymal stem cells found in the bone marrow of young adults and cultured in the lab. It was hoped that Prochymal might help ease graft-versus-host disease, a dangerous condition that can occur in patients after organ transplants.

But in one trial, patients who took Prochymal along with steroids had a 45 percent response rate, little different from the 46 percent response rate for those who took a steroid and a placebo. And in a second trial, conducted in patients who were not benefiting from steroid therapy, 35 percent of those receiving Prochymal showed a reduction in their graft-versus-host disease, compared to 30 percent of those on placebo -- not a statistically significant difference.

The drug's maker, Columbia, Md.-based Osiris Therapeutics, said that the second did show a statistically meaningful benefit for a subset of patients with graft-vs-host disease targeting the liver or gastrointestinal system. However, the Times noted that the U.S. Food and Drug Administration typically does not approve drugs that benefit only a subset of patients.

The failure of the drug to impress in these two trials suggests there's still much researchers don't understand about stem cells. "Understanding [these cells] well enough to translate to the clinic -- that's the hurdle we're at," Dr. Darwin Prockop, director of the Institute for Regenerative Medicine at Texas A&M Health Science Center, told the Times.

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HHS' Sebelius Counsels Kids with Asthma on Coming Swine Flu Season

The U.S. Secretary of Health and Human Services delivered a special message to students with asthma on Tuesday about how to stay healthy and avoid missing school as the H1N1 swine flu season approaches.

Kathleen Sebelius visited 7th graders at Thurgood Marshall Elementary School in Philadelphia. The school is a partner in the Merck Childhood Asthma Network (MCAN), which helps children better control their asthma.

Children with asthma are at high risk for complications from seasonal flu, as well as the H1N1 swine flu virus. "Nothing is more important than keeping our children healthy, in school and ready to learn as we start the new school year," Dr. Floyd Malveaux, executive director of MCAN and former dean of the College of Medicine at Howard University, said in an MCAN news release.

Addressing students and their parents, Sebelius emphasized the value of education and the need to develop healthy habits to stay well.

"Staying healthy can be a challenge for students with asthma -- a factor that is even further complicated with the possibility of being exposed to the H1N1 virus, which can increase the severity of asthma symptoms, leading to possible hospitalizations," Malveaux said.

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CDC Chief Says His Kids Will Get Swine Flu Vaccine

Parents who may be concerned about getting their children vaccinated with the swine flu vaccine shouldn't be.

That's the word from the head of the U.S. Centers for Disease Control and Prevention, Dr. Thomas Frieden, who said his kids are going to get the vaccine when it becomes available, sometime next month. The agency chief said the vaccine is being made in the same way that the seasonal flu vaccine is made each year -- except that it's a new strain, the Associated Press reported.

Frieden also said that now that schools and colleges are back in session, health officials are seeing a fair amount of the flu already. He made his remarks Sunday during an interview on CNN's "State of the Union."

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Glaxo Cervical Cancer Vaccine Up for Approval

A panel of experts for the U.S. Food and Drug Administration could recommend approval next week of a cervical cancer vaccine from GlaxoSmithKline, the Associated Press reported Friday.

Called Cervarix, the vaccine blocked the human papilloma virus (HPV), which is responsible for most cases of cervical cancer, nearly 93 percent of the time, the FDA said in documents filed online.

Cervarix already is permitted in close to 100 other countries. The FDA delayed a decision on its use in the United States in 2007, saying it needed additional information, the AP said.

Side effects from the vaccine, such as soreness near the injection site, were mild, the data showed.

When an expert panel convenes on Wednesday, the FDA will ask if Cervarix should be approved for women and girls ages 10 to 25. The FDA usually follows the experts' advice.

In related news, the FDA says Gardasil, the Merck vaccine used to prevent cervical cancer in women, also blocks the viruses responsible for genital warts in men.

Gardasil prevented genital warts in patients 90 percent of the time, the FDA said in documents presented online, the AP reported. The vaccine apparently blocks two strains of HPV that cause genital growths on males.

Merck is seeking FDA approval of Gardasil for boys and men ages 16 to 26, and a panel of advisers will consider the request next week.

Gardasil was approved for women in 2006.

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Posted: September 2009


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