Merck’s Garasil vaccine, promoted to prevent cervical cancer and genital warts, roared onto the market in 2006, but since then has decelerated sharply. Merck has been lobbying to increase its potential market to boys and mature women. It failed to persuade FDA to broaden use to older women–up to the age of 45–but now has convinced an agency advisory committee that Gardasil would be useful for boys and young men.
In twin votes likely to add considerable force to U.S. marketing efforts for HPV vaccines, an FDA expert panel has voted to back GlaxoSmithKline’s long delayed application to market its HPV vaccine Cervarix to women and soon after supported Merck’s application to extend the use of Gardasil to males. Glaxo shares gain 0.5 pct, Merck shares gain 1.9 pct.
Fresh controversies are heating up over the marketing of products to prevent cervical cancer The U.S. Food & Drug Administration is gearing up to make critical decisions about two controversial vaccines. On Sept. 9 an FDA advisory committee will consider whether Merck (MRK)’s Gardasil, given to girls to prevent cancer-causing human papilloma virus (HPV), should [...]
Amid questions about the safety of the HPV vaccine Gardasil one of the lead researchers for the Merck drug is speaking out about its risks, benefits and aggressive marketing. Dr. Diane Harper says young girls and their parents should receive more complete warnings before receiving the vaccine to prevent cervical cancer. Dr. Harper helped design and carry out the Phase II and Phase III safety and effectiveness studies to get Gardasil approved, and authored many of the published, scholarly papers about it. She has been a paid speaker and consultant to Merck. It’s highly unusual for a researcher to publicly criticize a medicine or vaccine she helped get approved.
Genital warts (condyloma) are small, fleshy growths that are found on the skin in the genital region. Most warts are painless, and many people don’t realize they have them. Occasionally, they spread and enlarge, looking like very tiny cauliflowers. The warts may be raised or reddened. Warts may sometimes also hurt or cause itching. They may grow on the large and small lips surrounding the vagina (vulva), around the anus, or on the urethra, cervix, vagina, rectum, bladder, penis, or scrotum. Genital warts vary greatly in size, color, shape, and texture, depending on where they are found.
The HPV test is helpful in women whose Pap test report is “ atypical squamous cells of undetermined significance”, often abbreviated as “ASC-US”. This means that the result is uncertain – it is not normal but it is also not abnormal in any precisely defined way. Some of these Pap tests with uncertain results show HPV infection on additional testing. So the HPV test can help your clinician understand the reason for the uncertain Pap. In addition, most experts believe that for women over 30, HPV testing along with a routine Pap test is the best way to screen for dysplasia or cervical cancer. This combination of testing is so reliable that if both tests are normal, the tests should be repeated only every three years.
Be sure to get regular check-ups, including Pap tests. If you see genital skin changes, make an appointment with your health care provider for an exam. These feelings are normal. It is common for people with HPV to feel angry, upset, depressed or ashamed about their condition. Some women may also be concerned about the risk for cancer. Keep in mind that HPV can be managed and cervical cancer can almost always be prevented. Talk to your health care provider about your concerns. Keeping yourself healthy and not smoking can help boost you body’s natural defense system to fight the virus.
HPV is a virus that is very common. In fact, most men and women are infected with HPV at some time in their lives. There are approximately 100 types of HPV. Some HPV typesonly infect the genital area and may cause warts, some cause mild changes in cervical cells that do not turn into cancer, and some cause changes that may become cervical cancer if present for many years. The types of HPV that are found in the genital areas are usually passed on during sexual contact (sexually transmitted). HPV types that cause warts on the hands or feet do not cause genital warts or cervical cell changes, nor do genital HPV types generally spread outside the genital area.
GlaxoSmithKline’s cervical cancer vaccine Cervarix has won a green light from the World Health Organisation (WHO) for use in developing countries, although how the shot will be paid for has yet to be resolved. WHO “prequalification” is necessary for UN agencies and the non-profit GAVI Alliance to purchase the vaccine, and Glaxo said it hoped the move would help speed access to Cervarix globally.
A study, published in Tuesday’s issue of The Lancet, said that as well as protecting against the two most common virus types, the GlaxoSmithKline Plc’s Cervarix vaccine also provides protection against the next three most common cancer-causing virus types. GlaxoSmithKline Plc’s is Europe’s biggest drug company.
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