Posted on 05/18/2006 3:40:25 PM PDT by RWR8189
WASHINGTON - A vaccine with the potential to slash worldwide deaths from cervical cancer, the No. 2 cancer killer in women, should be approved for sales in the United States, a federal panel said Thursday.
A Food and Drug Administration advisory committee voted 13-0 to endorse the safety and effectiveness of Merck and Co.'s Gardasil, which blocks viruses that cause cervical cancer. The company said the vaccine could cut worldwide deaths from the disease by two-thirds.
However, the anticipated cost of the vaccine, administered in three shots over six months, is $300 to $500 — a possible impediment to widespread vaccination campaigns.
The drug protects against the two types of human papillomavirus (HPV) believed responsible for about 70 percent of cervical cancer cases. It also protects against two other virus types that cause 90 percent of genital wart cases. All four virus types are sexually transmitted.
The FDA is not required to follow the recommendations of its outside panels of experts, but usually does. An agency decision is expected by June 8.
HPV is the most common sexually transmitted disease. It affects more than 50 percent of sexually active adults. The cervical cancer it can cause kills about 290,000 women worldwide each year, including 3,500 in the United States where regular pap smears often detect precancerous lesions and early cancer.
"This is certainly a wonderful, good step in addition to our screening processes" in helping eradicate cervical cancer, said Dr. Monica Farley, who heads the advisory panel. She is a bacterial infectious disease expert at the Emory University School of Medicine in Atlanta.
Early opposition to Gardasil was based on concerns it could encourage sexual activity in preteens and teens. But that largely faded away because of the vaccine's potential for reducing cancer.
Making their case for approval, Merck officials suggested that Gardasil could be the biggest advance in preventing cervical cancer since the pap test.
"Gardasil has the potential to meet an unmet medical need as the first vaccine to prevent cervical cancer," Merck's Dr. Patrick Brill-Edwards told the Vaccine and Related Biological Products advisory committee.
Several speakers said the vaccine should not replace screening. Merck said the vaccine was not intended to do that but that it could eliminate many of the abnormalities the tests turn up.
"We would like to see the FDA mandate some sort of labeling or other mechanism to communicate to health care providers and patients the continued need for regular cervical screening," said Amy Allina, program director of the National Women's Health Network.
Merck said the vaccine could be used in females age 9 to 26, but would work best when given to girls before they begin having sex.
The company is seeking to license Gardasil in more than 50 countries, said Dr. Eliav Barr, who headed the vaccine program at Merck.
Pending action by the FDA, the national Advisory Committee on Immunization Practices will decide in June whether to endorse routine vaccination with the vaccine.
The committee's HPV vaccine group is recommending giving the vaccine to girls 11 and 12. The 15-member committee of experts who advise the government will consider recommendations for females 13 to 26. Merck seeks use of the vaccine in girls as young as 9.
Dr. Nancy Miller, an FDA reviewer, cautioned that Gardasil does not necessarily protect against one or more of the four viruses in people already infected before they get the vaccine, and can increase their risk for precursors to cervical cancer.
Also, the drug does not protect against infection from the many other virus strains not included in the vaccine. In addition, FDA staff highlighted in briefing documents five cases where children with birth defects were born to women who received the vaccine around the time of conception. Merck said it was "highly unlikely" they were related to Gardasil.
Merck, based in Whitehouse Station, N.J., developed the vaccine and tested it in more than 27,000 females and males.
Thursday's discussion focused on its use in preventing HPV-related disease in girls and women, including those as young as 9. But only 250 9-year-old girls and boys received Gardasil in trials.
The anticipated cost of the vaccine, administered in three shots over six months, is $300 to $500. That could pose a barrier to widespread vaccination campaigns.
"The vaccine community will see this as an opportunity to prevent cancer. They will also see issues of availability and cost," said Dr. Bruce Gellin, a committee member and head of the federal vaccine policy office.
Analysts believe Gardasil sales could top $1 billion a year for Merck, which is battling thousands of lawsuits over its withdrawn painkiller Vioxx.
Punishing a woman with cancer because of your personal ideals of social engineering on the notion of promiscuousness is absurd.
Agree completely. And as many have pointed out in the past, a young woman who marries as a virgin can still get HPV from her husband - I wouldn't want my daughter to take that chance.
"Merck said the vaccine could be used in females age 9 to 26, but would work best when given to girls before they begin having sex".
Any young woman getting her birth control should get this vaccine at the same time.
Triumph of the "Virus Hunters". If it's like all of their other "triumphs" after Salk, avoid it.
So what is the recommended age to administer this vaccine in Muslim countries?
Any young woman getting her birth control should get this vaccine at the same time.
From what I read, the manufacturer found the vaccine produced a stronger immunological response in adolescents aged 10-15 than in women aged 16-23. Also, it was tested as a 3-dose regimen over 6 months. If a young woman waits until she gets her birth control, it could be too late.
"No. 2 cancer killer in women," the American Cancer Society begs to differ. pdf link of "Estimated New Cancer Cases and Deaths by Sex for All Sites, US, 2006*"
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