PHARMACY

Congressmen ask committee to explore FDA’s Provenge decision as ethics accusations arise

BY Drew Buono

WASHINGTON The House Energy and Commerce Committee is being asked by several members of Congress to investigate why the Food and Drug Administration did not approve Dendreon’s prostate cancer vaccine Provenge.

Earlier this year, the FDA requested more efficacy data for Provenge despite a positive vote from its Cellular, Tissues and Gene Therapies Advisory Committee. The committee voted 13–4 that Provenge was effective and 17–0 that it was safe. However, some cancer experts sent written requests to the agency asking that Provenge not be approved.

According to Reps. Mike Michaud, D-Maine, Dan Burton, R-Ind., and Tim Ryan, D-Ohio, conflicts of interest on an advisory committee could have contributed to the agency’s decision, “There are reasons to believe that serious ethics rules were violated by two FDA advisory panel members in their decision and that these violations played a role in the subsequent FDA decision to not approve Provenge at this time,” a letter from the lawmakers said.

In the letter sent to committee chairman John Dingell, D-Mich., the three congressmen said that prostate cancer activists have raised questions about two academic medical oncologists, Maha Hussain and Howard Scher, who voted against Provenge on an FDA panel in March.

Scher is a lead investigator for a competing cancer drug made by Novacea. The FDA should not be appointing scientists who are testing a rival drug for another company to an advisory committee, Michaud said, adding that the FDA can and should eliminate conflicts of interest in its advisory committee members to restore public confidence in the agency.

Hussain is an oncologist in the department of internal medicine at the University of Michigan. In an emailed statement, a spokeswoman from the University of Michigan Comprehensive Cancer Center said that Hussain completed the FDA’s paperwork disclosing potential conflicts of interest and a review by the school’s conflict of interest board found that Hussain complied with its policies.

In a statement published on his congressional Web site, Michaud said he believes the “FDA should not be appointing scientists leading the testing of a rival drug for another firm onto an advisory committee evaluating Provenge.”

He added that the committee “must examine conflict-of-interest issues with some medical advisors who are chosen to review drug therapies” at the FDA and that “a full disclosure is necessary in order to restore confidence in the FDA.”

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New Jersey adds flu vaccine to list of childhood innoculations

BY Adam Kraemer

PHILADELPHIA The state of New Jersey announced that, starting in September 2008, children entering day care or preschool will be required to have had flu vaccinations, despite some parents’ fears that the trace amounts of mercury in the vaccines could trigger autism.

The flu vaccine is an addition to the list of communicable diseases for which children in the state already are required to have before they can enter such social settings as day care or preschool, both situations in which contagious diseases are easily spread. “This is a public-health policy that is aimed at protecting children and the community at large,” Eddy Bresnitz, state epidemiologist and a deputy health commissioner, told the Philadelphia Inquirer.

Some parents, however, have expressed concern and even written letters to the Public Health Council in opposition to the change, mainly over safety concerns. While no scientific studies have found a link between thimerosal—a mercury-containing preservative once used in vaccines—and the triggering of autism in young children, some vaccines still contain trace amounts of the chemical and it’s enough to alarm parents.

“It is our feeling that parents have the right to make medical decisions for their families,” Sue Collins, a parent and leader of the New Jersey Alliance for Informed Choice in Vaccination, told the paper. “I don’t want trace amounts of mercury in my body or my children’s bodies under any circumstances. We know it is a dangerous toxin and yet we keep injecting it into our kids.”

“Thimerosol-free preparations are available, and the trace amounts in some preparations are truly tiny, tiny, tiny, tiny, tiny, tiny, tiny amounts,” said Craig Newschaffer, chair of the department of epidemiology and biostatistics at the Drexel University School of Public Health.

The new rules follow recommendations of the American Academy of Pediatrics and the U.S. Centers for Disease Control and Prevention.

New Jersey does allow exemptions based on medical and religious grounds, but not for “philosophical” reasons. “Flu is turning out to be a stealth killer,” said Robert Field, chair of the department of health policy and public health at the University of the Sciences in Philadelphia. “Seasonal flu, which most people can shrug off as an inconvenience for a week or two, is truly a threat to people at high risk, particularly the very old, the very young, and those with compromised immune systems.”

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Tibotec awards Medivir $24 million for drug development milestone

BY Drew Buono

STOCKHOLM, Sweden Medivir has received $24.54 million from Tibotec related to the development of the drug candidate TMC435350, which recently advanced into Phase II clinical trials at the end of November, according to published reports.

The money has come in two different payments. The first payment was for a clinical milestone reached by Medivir under the terms of the research and license agreement between the two companies; that amounted in $7.21 million for Medivir. The second payment is due because Medivir opted not to obtain the marketing rights to an approved product in the Nordic countries, which resulted in $17.32 million.

“Our goal is to achieve revenues from sales of licensed pharmaceuticals in the Nordic market in the coming 12 months,” explains Medivir’s chief executive officer Lars Adlersson. “A robust financial position will facilitate the creation of a Nordic sales and marketing organization and strengthen us in coming partnership negotiations.”

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