Health Highlights: Feb. 9, 2011
Congresswoman Gabrielle Giffords Now Speaking Agencies Probe Possible H1N1 Flu Vaccine/Narcolepsy Link FDA Questions Companies on Follow-Up Drug Studies Shingles Vaccine Shortage May Continue Until Spring
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Congresswoman Gabrielle Giffords Now Speaking
Less than a month after she was shot in the head in an assassination attempt, Rep. Gabrielle Giffords of Arizona started speaking again by asking for toast.
The simple request represents another significant advance for the 40-year-old Democratic congresswoman, the New York Daily News reported.
The fact that Giffords has started speaking is proof that she is displaying "encouraging signs everyday," her astronaut husband Mark Kelly wrote in his wife's Facebook page. Kelly is back at work at NASA and will command the April 19 launch of the space shuttle Endeavour.
"It is hard to believe that only one month has passed since Gabrielle was shot," Kelly wrote. "The doctors say she is recovering at lightning speed considering her injury but they aren't kidding when they say this is a marathon process."
He also noted that Giffords is eating three meals a day "even though it's hospital food," the Daily News reported.
Health Agencies Probe Possible H1N1 Flu Vaccine/Narcolepsy Link
A possible link between swine flu vaccine and the sleep disorder narcolepsy is being investigated by the World Health Organization and the European Medicines Agency.
Narcolepsy causes extreme fatigue and patients with the disorder often fall asleep without warning, even in the middle of an activity, according to Agence France-Presse.
The WHO said Tuesday that 12 countries have reported suspected cases of narcolepsy associated with the swine flu vaccine Pandemrix, which is made by GlaxoSmithKline and was used in 47 countries during the 2009-10 swine flu pandemic.
Children who received the vaccine were nine times more likely to develop narcolepsy than those who were not given the vaccine, according to a Finnish study that was reviewed last week by the WHO Global Advisory Committee on Vaccine Safety, AFP reported.
"The committee agrees that further investigation is warranted concerning narcolepsy and vaccination against influenza (H1N1) 2009 with Pandemrix and other pandemic H1N1 vaccines," the WHO said. "An increased risk of narcolepsy has not been observed in association with the use of any vaccines whether against influenza or other diseases in the past."
FDA Questions Companies on Follow-Up Drug Studies
Drug companies that failed to complete promised follow-up studies in exchange for accelerated approval of six cancer drugs were questioned Tuesday at a public meeting held by the U.S. Food and Drug Administration.
The companies -- which include Amgen Inc., GlaxoSmithKline PLC, and Eli Lilly & Co. -- said they faced a number of challenges in conducting the studies, including difficulty enrolling patients in clinical trials for already-approved drugs, the Wall Street Journal reported.
"These confirmatory trials are as important -- if not more important -- than the initial trials leading to the accelerated approval," noted Richard Pazdur, head of the FDA's cancer division.
While the FDA can levy fines of millions of dollars or revoke approval of drugs if promised follow-up studies aren't completed, agency officials did not make such threats at the meeting.
Pazdur suggested that companies should not apply for the accelerated drug approval process if they aren't confident they can complete the required follow-up studies on time, the Wall Street Journal reported.
Shingles Vaccine Shortage May Continue Until Spring
The vaccine to prevent shingles may be in short supply in the United States until April, according to the company that makes the vaccine.
Merck spokeswoman Pamela Eisele told USA Today that both the shingles vaccine Zostavax and the chickenpox vaccine Varivax are made with varicella, the virus that causes both diseases.
There is a limited supply of varicella and Merck must "prioritize" which vaccine to make. The chickenpox vaccine gets priority, Eisele said.
In early January, the U.S. Centers for Disease Control and Prevention recommended that most Americans over 60 get the one-time shingles vaccine, USA Today reported.