Gardasil Grope: Merck Lusts After Adult Women
29 CommentsBy Ed Silverman // October 27th, 2008 // 8:35 am
Never mind that a recent study found its HPV vaccine isn’t cost effective for women over 18 years old and that the FDA earlier this year rejected Gardasil for women between the ages of 27 and 45 (back story), Merck continues to push for widespread vaccination for adult women.
Over the weekend, researchers told the American Society for Microbiology and the Infectious Diseases Society of America that an aggressive strategy of vaccinating older women could cripple cervical cancer, which is traced to HPV.
Using a mathematical model, they showed that vaccinating women in the US by ages 12 through 45 against HPV could reduce cervical cancer cases by up to 55 percent for 45-year-old women, Reuters writes. The Reuters story, by the way, failed to note the speaker, Warner Huh of the University of Alabama, receives funding from Merck and Glaxo for consulting, research and speaking (look here).
The hard sell isn’t surprising, after vaccinations fell 33 percent in July and August compared with a year earlier and sales declined 4 percent in this year’s third quarter. Merck believes women up to age 26 were least likely to have been vaccinated during Gardasil’s initial availability. “We see tremendous opportunity,” Bev Lybrand, Merck’s senior vp of vaccines, recently told Bloomberg News. “We have a number of programs under way to get after these women.”
But convincing still older women may be difficult, since the recent analysis in The New England Journal of Medicine predicted that life expectancy gained by giving Gardasil to women older than 18 doesn’t outweigh the expense. The vaccine costs about $360 for a three-dose regimen. As noted last summer, though, Merck hopes to allay FDA concerns about vaccinating older women. Whether doctors and patients will be convinced remains to be seen.
UPDATE: We should note that Huh based his data on Glaxo trials for Cervarix, which is approved in Europe, but not yet in the US.
harpy
Can anyone tell me what the vaccine does if you already have a strain of HPV that Gardasil works against? Will it just not work?
Love the headline, btw.
Justice in MI
I was first imagining some negative respsone to the headline, and being sympathetic.
But then I read from the aptly named Lybrand;
““We see tremendous opportunity,” Bev Lybrand, Merck’s senior vp of vaccines, recently told Bloomberg News. “We have a number of programs under way to get after these women.”
Go after ‘em, LyBrand, Go after ‘em!
Marilyn Mann
Great headline.
There was a recent article in the Washington Post that said Merck sends text messages to teenage girls to remind them to get their second and third Gardasil shots. I wonder if that is true and, if it is, how Merck gets the girls’ cell phone numbers.
Ed Silverman
Hi Marilyn,
Not to boast too much, but I believe Pharmalot may have broken that story about the texting. You can read about it here…
http://www.pharmalot.com/2008/06/merck-to-text-teens-about-gardasil-reminders/
Cheers
ed
Marilyn Mann
Here’s the disclosure for Warner Huh from the Medscape CME article:
Warner K. Huh, MD
Associate Professor, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, The University of Alabama at Birmingham, Birmingham, Alabama
Disclosure: Grants/Research Support: Cytyc Corporation, GlaxoSmithKline, Merck & Co., Inc., MGI PHARMA, Roche Pharmaceuticals, Takeda Pharmaceuticals Inc., Tigris Pharmaceuticals; Consultant: GlaxoSmithKline, Merck & Co., Inc., MGI PHARMA, Nventa Biopharmaceuticals Corporation, Roche Pharmaceuticals, Takeda Pharmaceuticals Inc.; Speakers Bureau: Cytyc Corporation, Digene Corporation, Merck & Co., Inc.
joe
Of course older women should be vaccinated for cervical cancer, and so should older men. I understand HPV is rampant in the nursing homes. God forbid, Merck miss a golden (or silver) opportunity. I wonder if Medicare covers Gardasil.
And, using Merckʼs mathematical model, they should go after the dogs and cats, because we know theyʼre screwing around (the cats and dogs, that is).
Nathan
I fully expect Merck to continue expanding thier HPV vaccine — as they should. Did anyone see the ABCnews article about HPV causing 15,000 cases of oral cancer per year?
http://abcnews.go.com/GMA/OnCall/story?id=6034244&page=1
The NCI estimates that 11,000 cervical cancers per year are related to HPV infection. Based on the ABCnews numbers (backed up by the Oral Cancer Society numbers, link below), there are an additional 15,000 cases of oral cancer per year caused by HPV. Moreover, this link to oral cancer expands the Gardasil market to men and increases the “rational” for having the vaccine in the first place. The Gardasil web site does mention oral cancer, but only in passing. (I’m sure they can’t say much about it until they have the studies to prove a benifit) However, Merck is evidently studying the use of the vaccine in males. (http://www.cdc.gov/std/HPV/STDFact-HPV-and-men.htm)
Another interesting link is this one. The oral cancer foundation believes based on recent literature that HPV infection is now surpassing chewing tobacco as the primary cause of oral cancer. Moreover, oral cancer is far more lethal than cervic cancer (only 50% of oral cancer patients are alive 5 years after diagnosis).
http://www.oralcancerfoundation.org/facts/
Anyway, it’s interesting and this is a vaccine I’m sure we’ll be hearing about for years to come. (Hopefully in a more positive light than has been given it on this website…)
pharma PR hack
Seriously nathan — did you miss the really informative NYT piece on preventative healthcare?
http://www.nytimes.com/2008/10/07/health/views/07essa.html?_r=1&scp=1&sq=preventative%20medicine&st=cse&oref=slogin
Does it really make sense to use private health insurance and public health monies on something that kills less than 4,000 individuals a year??
We are talking about a vaccine that stops a few strands and there really isn’t hard data about the length of efficacy–
the oral cancer link is tenuous at best similar to the herd immunity being trumped by the other merck vaccine for rotavirus.
Each of these medications would be substantial public health imperative in a third world or emerging democracy where the condition of rotavirus leads to death and screening pap smears are an anomally. But that isn’t really a bottom line builder for Merck so instead we have marketing campaigns to twist into a public health need in the US.
Lisa Van S
Hello,
“FDA earlier this year rejected Garsisil for women ages 27 thru 45″.
Good enough reason for me to reject being immunized!!!!!
Nathan
pharma PR hack,
All I’m saying is that there is an established link between oral cancer and HPV-16 (which Gardasil DOES protect against). It’s something I’m sure that Merck is looking into, as it should. There may be a market here beyond HPV.
You can scoff all you want, but the entire premise that a virus can cause cancer was scoffed at just a few years ago. Now the link has resulted in a nobel prize. Do you think that HPV is the ONLY virus that causes cancer? Do you think that cervical cancer is the ONLY cancer caused by HPV? I, for one, am glad that there are researchers studying the link. Time will time.
Lisa Van S
Nathan,
Im sure you meant to say time will tell. Yes.
pharma PR hack
Nathan- I am fine with the researchers studying the link. I am not fine with the four star media push for a vaccination that is still less than 10 years on the market for a disease that affects such a small number of individuals fatally– it is a matter of healthcare economics. Just because pharma got a drug approved for a disease doesn’t make that disease a public health epidemic.
There are only so many things we as a nation can afford and eventually there has to be some spending priority or everyone loses.
Nathan
Pharma PR Hack writes: “it is a matter of healthcare economics. Just because pharma got a drug approved for a disease doesn’t make that disease a public health epidemic.”
I agree completely. I think it’s valuable — but as a society, there is only so much money we can spent on mitigating minor risks. Undoubtedly in the future there will be multiple levels of healthcare. This would fall into a “lower-tier” of importance.
Christopher
Maybe Gardasil (or cervical cancer?) would fall into a ‘lower-tier’ but if I was in one of the 4,000 families which each year lose someone to a cancer that might have been prevented I’d be thinking otherwise.
Lisa Van S
Christopher,
An informed woman will make a decision that is appropiate for herself. Bev Lybrand,.. curious as to when she became the VP for vaccines,…. hmmm maybe when Merck launched Gardisil.
One more thought, vaccinate the men, or make them wear condoms!.
Nathan
Lisa,
Actually I completely agree with vaccinating sexually active men/boys.
(and condoms generally do not protect against HPV — they give only ~70% protection at best)
Lisa Van S
Nathan,
Long term efficacy of Gardasil is unknown, and Gardisil doesnt prevent HIV/AIDES. Advice I give to my 20 year old son,.. OFTEN is, NO Glove,.. No Love.!!
harpy
I find it strange, Nathan, that you would push so hard for a vaccine that protects against the 2 strains of HPV that cause ~70% of cervical cancers and then turn around and say condoms generally don’t prevent the spread of HPV because they give only ~70% protection at best.
Even if the vaccine works 100% against those 2 strains - doesn’t make more sense to try to not get HPV in the first place by using condoms? From what I’ve read, most cases of HPV clear themselves and it is persistent recurrences that lead to cancerous growth. Therefore, if you can prevent ~70% of infections by using a condom, the risk of developing cancer from HPV infections drops dramatically.
Listen to Lisa - No glove, no love
Nathan
harpy,
The only 100% effective approach is abstinence. Are you an advocate of abstence-only education since that is the only tool that is 100% effective?
Both tools are 70% effective. Combined, they have the ability to essentially eradicate a disease that results in 4000 deaths per year from cervical cancer and thousands more deaths per year of oral cancer. (see the link you posted: they also link HPV to cancers of the anus, vulva, vagina, penis, mouth, and throat)
We’ve entered an era where viruses are a proven cause of cancer. The BEST way to treat that cancer is to avoid the viral infection. I advocate any and all mothods of limiting the HPV infection.
Lisa Van S
Nathan,
Can you site a few studies that state condoms are only 70% effective, 70% seems a bit low.
harpy
(and condoms generally do not protect against HPV — they give only ~70% protection at best)
I was merely pointing out what seemed to be a contradiction in your support for the vaccine vs. your support for condom use, Nathan. If one can prevent recurrent HPV infections - wherever in the body they occur - then the chance of getting cancer is lessened. So is the chance of getting HIV, gonorrhea, syphilis, and other STDs. Not to mention pregnancy.
And your logic regarding abstinence is flawed. While abstinence may be the only way to avoid STDs altogether, abstinence education is a completely different ball of wax and one that has been proven to be ineffective in most cases. All I’m going to say is good luck with that.
Lisa - Here is a link to an ABC News story that cites a University of Washington study. It’s where I found the 70% estimate.
Lisa Van S
thanks Harpy,
70% seemed low to me, I still advocate condems.
Nathan
harpy,
I miswrote about abstinence. I meant to write that abstinence ITSELF is the only 100% effective tool — not abstinence education.
As I said - condoms are an effective tool in the prevention of HPV, and I believe vaccination is also an effective tool. Remember that since we are talking about a communicable disease, the benefits of both extend beyond the individual. Hypothetically speaking, your son may not be vaccinated — but if he sleeps with my daughter (who IS vaccinated) then his chances of getting HPV and passing it along are lowered even though he never took the vaccine.
Vaccines have a societal benefit that extends beyond just individual protection.
Lisa Van S
Nathan,
Shouldnt we also discuss with our children the “Dangers” of having multiple partners. Again, whether they are vaccinated or not, the motto should be, No Glove,.. No Love…
Nathan
Lisa,
I take it a step farther: I’m going to be teaching my children “no marriage lisence, no love”. But I’m still going to get them vaccinated anyway. Kids can rebel against thier parents — but they can’t rebel against their immune system!
Lisa Van S
Nathan
Kids can rebel against their parents” OOOOH they sure do! But Psychiatrists diagnose it as Oppositional Defiant Disorder, a Mental Illness in the DSMIV, Zoloft along with an antipsychotics is their choice of treatment.
King Canute
‘No Glove,…No Love’ is catchy but it is perhaps useful to help kids distinguish between Love and Sex too.
KC
Lisa Van S
KC,
I agree 100%,.. Pretty tough when Society interferes. Catch Phrase,.. absolutely. It grabbed my teen son’s attention.
john07
It Is expensive & can be afforded by some people only so finally i want to avoid it.
———
john
adults only