Personal Injury Law

Merck's Gardasil For Boys?

By Jane Akre

Gardasil for Boys?

Merck would love to expand use of the cervical cancer drug, Gardasil, to include boys and young men.

Since the drug fights two strains of cervical-cancer-causing human papillomavirus (HPV), and two strains that cause genital warts in males, drug maker Merck has applied to the Food and Drug Administration (FDA) to have it approved for use in boys and young men.

It is already approved for use in girls and young women.

The FDA is meeting Wednesday to consider the application for use of the drug on males between the ages of 9 and 26, reports Reuters.

Company documents released Friday show the vaccine is safe and prevented genital warts in males 90 percent of the time, said FDA reviewers who looked at the company's data on Friday.

Merck studied 4.000 patients comparing patients taking Gardasil to those on a placebo. The FDA has posted the company documents on its Web site.

Merck has asked the FDA to consider the prevention of precancerous growths on the penis and anus, but reviewers say there were too few precancerous growths to evaluate, since penile and anal cancers affect less than 1 percent of the population.

The agency generally follows the advice of its advisory panels.

Critics say that the price does not justify the drug. At $400 for a three-dose series, it is still unknown how long protect lasts against HPV and whether a booster shot is necessary.

Gardasil made Merck $1 billion last year.

Ceravix

Gardasil rival, Ceravix, made by GlaxoSmithKline Biologicals (GSK), will also be the focus of an FDA advisory panel considering its approval in the U.S. The drug is already approved for use in Europe.

An FDA approval was delayed in 2007 because of fears the vaccine might cause even more cases of muscular and neurological problems than Gardasil.

FDA reviewers noted a higher number of miscarriages among females given Ceravix, but did not link the drug or rule out the drug as the cause, reports the New York Times.

HPV

HPV is contracted by about 80 percent of women, but usually clears up on its own.

According to Judicial Watch, a Washington D.C. based nonprofit public interest group, there have been nearly 9,000 adverse health events reported to the government concerning the drug, including a number of deaths reported since September 2007 and at least 18 deaths.

Of those 18, eleven occurred less than one week after receiving the vaccine and seven in less than two days.

About one in four teenage girls ages 13 to 17 have received the Gardasil vaccine as of last year, the Centers for Disease Control and Prevention estimates. #

Full post as published by InjuryBoard on September 04, 2009 (boomark / email).