|Michelle Fay Cortez and Shannon Pettypiece
Merck & Co.'s Gardasil shot, used to prevent cervical
cancer in women, slashed the risk of genital warts and pre-cancerous lesions
by 90 percent in men, according to the largest study of the vaccine in
Merck said it will use the data to seek U.S. approval to
sell Gardasil for males this year to protect against warts and the lesions,
which may lead to cancer of the penis and anus. The shot protects against
the sexually transmitted human papillomavirus, or HPV.
Gardasil, approved for females ages 9 to 26, is given
mostly to school-age girls as a U.S.-recommended routine vaccination. The
vaccine is designed to prevent HPV infection, which causes cervical cancer
and genital warts, and has been linked to cancers of the penis and anus in
men. Expanding the vaccine to males could revive sales, which declined 4
percent in the third quarter, analysts said.
``We finally have something we may be able to offer men as
well as women,'' said Anna Giuliano, professor of medicine and epidemiology
at the University of South Florida and a program leader in risk assessment
at the H. Lee Moffitt Cancer Center in Tampa, Florida. ``It really opens the
door to preventing infection and hopefully cancer and genital warts in
The research, funded by Whitehouse Station, New
Jersey-based Merck, is being presented today at the European Research
Organization on Genital Infection and Neoplasia in Nice, France. Merck rose
$1.81, or 6.8 percent, to $28.53 at 4:04 p.m. in New York Stock Exchange
Researchers gave 4,065 males ages 16 to 26 three shots of
the vaccine or a placebo, then tracked them for signs of infection with HPV.
After about 30 months, three men getting Gardasil developed genital warts
and none had pre-cancerous growths linked to the HPV virus, compared with 28
cases of warts and three pre-cancerous lesions in the placebo group.
HPV may cause about 1,500 men to develop penile cancer a
year and 1,900 to get anal cancer, according to the Centers for Disease
Control and Prevention. Men who have sex with men are 17 times more likely
to develop anal cancer from HPV, the CDC said.
None of the men were infected with HPV before the start of
the study. The vast majority of those in the trial, 3,400 volunteers, were
heterosexual males. Men are viewed as the key transmitters of HPV to women.
Another 600 were homosexual men, who have an elevated risk of developing
The shot also reduced the likelihood that the men would
develop persistent HPV infection, when the virus is detected in two or more
consecutive doctor visits.
Expanded use of Gardasil to men and boys can help revive
sales, which fell 4 percent to $401 million in the third quarter. About 2.5
million girls ages 13 to 17 were vaccinated with Gardasil last year,
according to CDC. The company has been less successful in persuading young
women to get the shot, which has limited sales of the product.
If approved for males, more than 350,000 boys and young
men, ages 11 to 26, could get the $400 vaccine next year, increasing to more
than 1 million annually by 2011, Merrill Lynch analyst David Risinger
estimated in a Sept. 4 research report. He expects the vaccine could reach
$2.7 billion in peak sales in 2011.
The shot protects against infection caused by HPV types 6,
11, 16 and 18 -- four of the 40 types of the virus found in the genital
area. More than 1 million cases of genital lesions, which can lead to
cancer, occur in men and women in the U.S. each year, and 30 million cases
occur worldwide, Merck said in a statement.
While 20 million Americans are infected with HPV, most
will be able to fight off the infection naturally. About 1 percent of
sexually active men in the U.S. will develop genital warts from HPV, the CDC
said. Gardasil is already approved for males in 40 countries worldwide.
It's unlikely that U.S. doctors will start to give the
shot to boys at this stage, since the Food and Drug Administration hasn't
reviewed the findings and more data is coming, Giuliano said.
``The first really important step is to have Merck do a
filing with the FDA, and have the FDA make a decision,'' she said.
``Although I think you get sporadic use of vaccines off label, I don't think
it would ever be common practice.''
The CDC's vaccine committee will meet next year to
consider whether the shot should be recommended for boys, Giuliano said.
Merck also is awaiting an FDA decision about whether the
company can market the vaccine for women through age 45.