Big FDA Decisions Coming Soon on Two Controversial Vaccines

In the next week, an advisory panel of the Food & Drug Administration is expected to make decisions on two controversial vaccines designed to treat a commonly carried virus that is a primary cause of cervical cancer.

The committee of medical experts that advises the FDA on new drug approvals is set to consider whether Gardasil, the Merck vaccine given to millions of girls and young women to prevent cervical cancer caused by the human papilloma virus (HPV), should also be approved for treating boys and young men, who also may carry the virus.

Also on the committee’s calendar is consideration of whether to approve a new HPV vaccine, Cervarix, which is made by GlaxoSmithKline and would directly compete with Gardasil.

While the FDA is not required to follow the advice of its panels, it most often does, so the Sept. 5 meeting is being closely watched as an indication of the future of Gardasil and similar vaccines.

Questions About Gardasil Marketing Dog Merck

Gardasil is a big seller for Merck, earning about $1.4 billion in 2008, but it also has generated widespread controversy. Since it was approved in 2006, many have raised questions about user deaths and severe adverse effects including development of a rare nervous system disorder in some people who received the shots. Others have criticized marketing tactics Merck used to promote the drug.

Critics have accused Merck of over-selling a vaccine for the prevention of a disease that can effectively be screened with regular pap smears and of paying medical organizations for favorable research on Gardasil.

As many as 11,000 new cases of cervical cancer are diagnosed in the United States each year and about 4,000 women die of the cancer annually. Gardasil and similar HPV vaccines could prevent about 70 percent of such cases, experts say.

Expand Gardasil for Use in Boys and Men?

Although boys and men cannot develop cervical cancer and cancers caused by HPV in men are considered rare, the thinking by some is that they should be vaccinated for HPV as well to prevent passing the virus onto female sex partners, who may develop the disease.

Opponents of expanding Gardasil for treating HPV in boys and young men say the request is a just a money grab by Merck looking to broaden the patient base for the vaccine that has seen sales taper off and fall amid questions of its use in girls and young women.

The makers of Cervarix don’t want FDA approval to use the drug in boys and men, but they do want the go-ahead to begin marketing the vaccine for use in treating HPV and preventing cervical cancer in girls and young women.

No matter the decision made by the advisory panel, the vote is likely to send shockwaves through the medical community. Stay tuned for more details on what the panel decides.

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