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Loading ...Virus vaccine maker seeks approval for males
01.07.2009 11:47am EST
(Trenton, New Jersey) Drugmaker Merck & Co. has asked federal regulators to approve use in males for its vaccine against the human papillomavirus, which causes cervical and other sexually transmitted cancers.
The application was submitted in late December, Merck spokeswoman Amy Rose said this week.It was long planned as part of Whitehouse Station, N.J.-based Merck’s strategy to increase the market for Gardasil. It prevents infection with the sexually transmitted virus and thus cancers of the genital organs.
Gardasil, launched in 2006 for girls and young women, quickly became one of Merck’s top-selling vaccines, thanks to aggressive marketing and attempts to get states to require girls to get the vaccine as a requirement for school attendance.
However, it is one of the priciest vaccines on the market, typically costing $360 for a three-dose regimen.
Gardasil had 2007 sales of $1.5 billion, but sales began slowing in the second half of 2008, after a government-funded Harvard study concluded it was cost-effective for girls but not for women in their 20s.
The U.S. Food and Drug Administration has two months to decide whether the application for use in males meets its standards. Reviews can then take 10 months or more.
The application includes research data from a Merck study including about 4,000 males, ages 16 to 26; Gardasil prevented 90 percent of cases of penile cancer and genital warts caused by the four common virus strains targeted by the vaccine.
The agency approved use of Gardasil in females ages 9 to 26 years old in June 2006, but last June rejected expanding that to include women ages 27 to 45. The vaccine has since been approved for use by young women in dozens of foreign countries.
A rival vaccine called Cervarix, made by Britain’s GlaxoSmithKline, is approved in many foreign markets, but generally lags behind Gardasil in sales. It is still awaiting approval in this country.
I have had 3 recurrences of HPV anal cancer since 1994with surgery, radiotherapy and more surgery and anal skin grafts. I am also HIV positive, I urge all gay guys who are over 40 to have regular anal pap tests – if you smoke be even more vigilant. Often a Dr can detect changes by a visual examination but that is when the the situation is advanced. Detect early and treat early is my mantra. I wouldn’t want anyone to go through what I have had to
Kris, rectal bleeding is not normal. Regardless of the cause, you should have it worked up. If you do not have a medical provider, or if you have one but do not feel comfortable discussing your sexuality with him, or if he is unwilling or unable to perform an anal pap (usually only indicated if you are HIV+), visit the GLMA website to find a gay friendly provider near you.
Kris – I would ask your doctor immediately to do a male PAP-test. I thought that I just had a hemoroid (which tend to bleed too). By the time it got to AIN3, I had a growth which had to be cut out. So far the surgeon thinks that they will not have to take my muscle tissue (yet anyway), so I will still be able to control myself, for the most part. I’ll likely have to wear a pad of some sort for the rest of my life though. Unfortunately, the stage 1 and 2 are not easy to see, so testing must be done. It may even require a biopsy if your doctor sees something suspicious.
Shawn – I was living in Central America where the ethics and laws are less strict. However, two days after my partner was diagnosed, the clinic was closed and I read in the paper that the “doctor” was arrested. I hate to think about how many other people he killed.
A “clinic” was giving out Negative readings without even TESTING the samples?!? What and WHERE exactly is this clinic, if you don’t mind me asking?
I’ve been diagnosed with the HPV virus also. I was wondering what some of the signs of “the AIN 1,2 & 3 are? I have been having rectal bleeding for a couple months, and just thought I would ask. Thanks
On New Year’s Eve day, I underwent surgery to remove a 1×3 in tumor, extending one inch outside and two inches inside of my rectum. We are still waiting the results of the pathology to determine if I need chemo or radiation. The diagnosis was AIN3, the “three” indicating that the cancer cells had become as bad as it gets. So far it appears that the cells only extended to skin, not muscle tissue, which is good news. I am also HIV+. I became infected with both the HIV and HPV while in a monogomous, long-term relationship. Before becoming intimate, my partner and I went to a clinic to determine our HIV status. Turns out the clinic was printing out negetive results without actually doing any test. He died in 1998. I found out about the HIV when he died, and about the HPV three weeks ago. I urge every gay male to ask your doctor to do a male pap-test, as this is the only way my condition was found (I just thought that I had a bad hemeroid). If you are HIV+, you have a much higher chance of HPV too. Please ask your doctor to check – It is much easier while in the AIN1 or even AIN2 stage to treat. I’m hoping that the news will be good for my outlook, but I will live with the fear of recurrance for the rest of my life.