Friday, May 19, 2006

HPV Vaccine Closer To FDA Approval

From Forbes:
A vaccine that blocks infection by the two types of viruses that cause most cases of cervical cancer is safe and effective and should be approved, a federal panel recommended Thursday.

A Food and Drug Administration advisory committee voted 13-0 five separate times to endorse the vaccine, known as Gardasil and made by Merck and Co.

The vaccine could reduce by more than two-thirds the number of deaths worldwide from the second-leading cancer in women, according to the company.

The drug protects against the two types of human papillomavirus (HPV) believed responsible for about 70 percent of cervical cancer cases. The vaccine also protects against two other virus types that cause 90 percent of genital wart cases. All four virus types are sexually transmitted. Update 3: Cervical Cancer Vaccine Gets FDA Panel OK

You remember the controversy here, right? Groups like the Family Research Council opposed this vaccine, because it might encourage unmarried women to have sex. It's better in their eyes to let them get cancer and die than to risk the chance of sex outside of a "traditional" marriage.
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 each year about 290,000 women worldwide, including 3,500 women 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.

Making their case for approval, Merck officials suggested that development could make Gardasil 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.

Of course, this is not a done deal. The physicians recommend it, unanimously, but the political appointees still have a shot at it.

Whaddya think? Will the FDA approve this vaccine? Personally, I wouldn't bet on it.


Anonymous Steve Boese said...

I heard one of the conservatives who had voiced concerns a year ago (that the vaccine would only encourage promiscuity, and needed to be stopped) stepping back from his opposition. (Sorry, don't remember who; I think it was on CNN.)

But, in today's world, I don't trust that he wasn't being publicly accepting because he already had private assurances that the FDA would sidetrack the vaccine's approval.

May 19, 2006 4:51 PM  
Blogger Dana Beyer, M.D. said...

It will be approved. The battle will be over who is to get it. It should be 12 year old girls, and should be required for entry into high school, for example.

May 19, 2006 11:33 PM  
Anonymous Anonymous said...

If Family Research Council opposes approval of the vaccine, I would disagree with them but from Jim's link I only see that were opposed to parents giving to teens not necessarily to FDA approval. Obviously, requiring it for entry to high school is another matter. Even more obvious, this should be a matter of parental judgment not governmental fiat.

May 20, 2006 11:27 AM  
Anonymous PasserBy said...

so Anon, how were you when your kids got polio shots, TB shot, mumps shots, tetnus shots ... Did that "government fiat" thing bother you then?

You think it's ok for some people to perpetuate an epidemic at the expense of others?


May 20, 2006 12:14 PM  
Anonymous Anonymous said...

"You think it's ok for some people to perpetuate an epidemic at the expense of others?"

Hmmm...I don't know. Do you think promiscuity deserves the same presumption as breathing?

May 20, 2006 2:29 PM  
Blogger Dana Beyer, M.D. said...

So, let's see, Anon, according to you, sex = promiscuity. I'm glad you made that clear.

And also, according to you, the government has no obligation to the public health -- that should be left up to parents. It's interesting, but I would think that someone with your perspective would be even more inclined to support vaccinations. Let's imagine your daughter who is sincerely interested in abstaining from sex until she gets married. But, one day, in the heat of the moment, she slips and performs orally on some guy with HPV. Thereafter she doesn't slip, gets married, and develops cervical cancer because of that one slip. Would that please you? Now, really, would it? Do you honestly believe she would be more likely to have any kind of sexual contact because she had a vaccination when she was 12 which she undoubtedly doesn't even remember anyway?

May 20, 2006 3:44 PM  
Anonymous Anonymous said...

That does it. Unless the previous comment from Dr D is deleted, I'll never post here again.

May 20, 2006 9:00 PM  
Anonymous Anonymous said...

HA HA ...joking right...?????


May 20, 2006 10:45 PM  
Blogger Orin Ryssman said...

FWIW, I vote that the FDA approve it...though I would not make it a's why (though I could be wrong on this...),

Are not vacines generally for highly communicable diseases? Is HPV highly communicable?

The rationale for govt funding of vacines and vaccinationprograms is that it reduces the percentage that are vulnerable to the disease in question. My understanding is that public health officials get nervous when the percentage of UNvaccinated rises above a set number...say 20%, for example (anyone know the figure?)

I guess what I am saying is that an effective political strategy for short-circuiting any conservative attempts to block approval would be to have it approved with a directive that vaccination be "strongly encouraged, but not required".

I know I would get my two daughters vaccinated...

May 24, 2006 3:40 AM  
Blogger Christine said...

Orin asked, Are not vacines generally for highly communicable diseases? Is HPV highly communicable?

According to the CDC:

"How Common is HPV?
At least 50% of sexually active people will get HPV at some time in their lives. Every year in the U.S., about 6.2 million people get HPV. HPV is most common in young women and men who are in their late teens and early 20s.

...Are HPV vaccines safe?
Both vaccines have been tested in thousands of people in many countries around the world. So far, the HPV vaccines have been tested in females ages 9-26 years. One vaccine has also been tested in boys ages 9-15. There appear to be no serious side effects. The most common side effect is brief soreness at the injection site.

Before any vaccine is licensed and made available to the American public, the FDA will have to approve it as safe and effective. The FDA is now reviewing one of the vaccines.

Who decides who should be vaccinated and when?
Once a vaccine is licensed by the FDA, the federal Advisory Committee on Immunization Practices (ACIP) will recommend who should get the vaccine and what the best ages are for receiving the vaccine. The ACIP has already begun reviewing the HPV vaccines.

Should girls/women be vaccinated? If so, at what age?
The vaccine would be most effective if given before girls become sexually active. It is not yet known what the best ages will be for them to get the vaccine.

Should boys/men be vaccinated? If so, at what age?
If the FDA licenses the HPV vaccine for boys as well as girls, the Advisory Committee on Immunization Practices (ACIP) will consider whether boys should get the vaccine and what ages would be best. It is possible that the vaccine may be licensed for girls before it is licensed for boys. This is because there is no information on how well the vaccine works in boys and men at this time. If the vaccine is recommended for boys and men, the vaccine would be most effective if given before boys become sexually active."


May 25, 2006 8:01 AM  

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