PHARMACY

FDA announces names of Risk Communication Advisory Committee members

BY Drew Buono

WASHINGTON The Food and Drug Administration has selected the 15 members that will make up the voting committee for its Risk Communication Advisory Committee, which will help the agency strengthen how it communicated products risks and other information to the public.

The members of the committee an their areas of expertise are:

  • Baruch Fischhoff, chair—risk perception and communication, decision analysis
  • Christine M. Bruhn—food safety communication, risk perception
  • David P. Moxley—social work, risk/behavior communication
  • Jacob DeLaRosa—surgical devices, risk communication to patients
  • Linda Neuhauser—health literacy, health communications in state government
  • AnnaMaria DeSalva—public relations, risk/crisis communication, trust building
  • John E. Paling—risk communication, broadcast media, risk perception
  • Michael Goldstein—behavioral medicine, risk and health communication
  • Ellen M. Peters—numeracy, risk perception, decision analysis
  • Prerna Mona Khanna—medical broadcast journalism, disaster support
  • Betsy Lynn Sleath—pharmacy, sociology, health literacy, health communication
  • Madeline Y. Lawson—advocacy, minority health
  • William K. Vaughn—consumer advocacy, policy
  • Musa Mayer—patient advocacy, counseling, journalism
  • Marielos L. Vega—health communication

Although the Institute of Medicine, which recommended the formation of the committee in 2006, recommended that the committee focus on medical product safety information, the FDA has expanded its role to cover communication about all agency-regulated products, including food, deputy commissioner for policy Randall Lutter said.

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Scientists in Oklahoma are hopeful about Alzheimer’s vaccine

BY Allison Cerra

OKLAHOMA CITY Oklahoma City scientists have developed a vaccine that could restrain or even thwart Alzheimer’s Disease, according to The Oklahoman online.

The vaccine, designed to fight dementia in the brain via the human immune system, could reach human clinical trials in three to four years, according to officials at the Oklahoma Medical Research Foundation.

“These results are extremely exciting,” said Jordan Tang, OMRF researcher who led the laboratory study that resulted in the vaccine. “They certainly show that this vaccination approach warrants additional investigation as a therapy for Alzheimer’s disease.”

The illness, a fatal, memory-robbing disease, affects several million Americans, including 70,000 Oklahomans. November is National Alzheimer’s Disease Awareness Month.

Results of OMRF’s vaccine research appeared in the Oct. 21 edition of The Journal of the Federation of American Societies for Experimental Biology. “This is the first time this type of Alzheimer’s vaccine has been produced anywhere. Other types of vaccines have been tried, but have failed,” OMRF spokesman Adam Cohen said.

Tang had pointed out that while the vaccine should be an addition to developments to cure the disease, rather than a substitution, the vaccine is still in its critical stages.

Back 2002, the pharmaceutical company Elan halted trials of a different vaccine after 15 patients suffered swelling of the central nervous system. OMRF president, Dr. Stephen Prescott, said he’s hopeful Tang’s work will avoid the pitfalls that weighed down Elan’s vaccine. “This vaccination stimulates the immune system more gently than previous Alzheimer’s vaccines, so we are optimistic about its prospects going forward,” he said.

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Avastin study on pancreatic cancer effects mixed results

BY Allison Cerra

ZURICH , Switzerland A new late-stage study of Roche Holding’s Avastin, and its effectiveness to slow down or avert pancreatic cancer in patients, had mixed results, the company said Tuesday.

The Swiss drugmaker said that although the addition of its drug to a Tarceva-chemotherapy combination failed to prolong the lives of patients with advanced pancreatic cancer, certain subjects did have some benefits when using Avastin.

Roche said that the study, which included 607 patients, showed that adding Avastin prolonged the time patients lived without their cancer worsening, as well as adding safety benefits.

An earlier trial, the company said, utilizing the same experiment, concluded that the addition of Avastin had shown no benefit in the treatment of pancreatic cancer.

Roche, which sponsored the study known as AVITA, plans to further analyze the data to determine the extent of the benefit of adding Avastin to the Tarceva-chemotherapy combination. The new details that surfaced from the study will not be published, the drugmaker said.

Pancreatic cancer, deemed the most difficult form of cancer to treat, is frequently resistant to chemotherapy and radiotherapy, and tends to spread quickly to other parts of the body. It leads to the shortest life expectancy of any major tumor.

Avastin, which hinders the growth of tumors by restraining their blood supply, was jointly developed with Genentech, a U.S. biotechnology company (majority-owned by Roche), and is seen as one of Roche’s most important drugs.

Financial experts believe Avastin will eventually become Roche’s best-selling drug, according to Dow Jones, since the drug is expected to be approved to treat several types of cancers.

Avastin was first approved in the U.S. in 2004 for the treatment of advanced colorectal cancer, and was approved for the treatment of lung cancer one year later. It is currently awaiting sanction for use in breast cancer. In Europe, it won approval for the treatment of advanced breast cancer and lung cancer earlier this year.

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