
Merck & Co., responding to mounting criticism over its strong-arm tactics, says it will stop lobbying state officials to require that girls receive its Gardasil cervical cancer vaccine before they can attend school.
The giant drugmaker said it made the decision after several groups, including the American Academy of Pediatrics, said there wasn’t enough state funding to pay for the $360 vaccine.
What Merck did not say was that there was growing criticism over it hijacking public-health policy in the service of marketing a drug that represents a potential $3 billion in annual sales.
“Merck’s early push was not the way to go,” said Larry Pickering, executive secretary of the advisory committee on immunization practices for the U.S. Centers for Disease Control and Prevention, in Atlanta. “We want to convince people to use the vaccine because of its benefits. Immediately implementing school laws is not optimal. We need to gather more data and reevaluate to see whether this kind of approach is necessary.”
No matter, Merck accomplished what it set out to do — garner loads of free publicity as legislatures in 20 states considered or adopted mandatory programs for middle school-aged girls to be vaccinated. When the publicity began turning bad, the drugmaker said it would stop lobbying. For the time being.
As I noted in a post on Monday, there is no question that Gardasil is a breakthrough drug because it dramatically reduces the odds of women getting deadly cervical cancer as a result of being infected by the human papillomavirus (HPV).
Texas Governor Rick Perry’s recent decision to require 11- and 12-year-old girls to be vaccinated with Gardasil ignited a firestorm of controversy among conservative religious and sexual abstinence advocacy groups who claim it will encourage young girls to have sex. Texas and other state have opt-out provisions for parents who do not want their daughters to be inoculated.
But lost in the debate is a huge question:
If Gardasil is so good at pushing back against the epidemic of sexually transmitted infections and diseases, why not give it to males as well?
HPV is not even casually contagious, but German measles, measles, mumps and chicken pox are, and both females and males are routinely immunized because inoculating everyone is the only way to suppress and eliminate those diseases.
Sources tell me that Gardasil tests are underway at Merck involving men and that the vaccine eventually will be offered to them, as well.
Groups such as the Family Research Council and Focus on the Family oppose making the shot mandatory and say parents should make the decision for their girls. Other groups have also questioned the need for making the vaccine mandatory since HPV isn’t spread by casual contact.
More here.
Shaun,
While I think your point about vaccinating men is valid, it’s not at all unusual for a pharmaceutical product to be brought to market for one particular population first. That allows the company to begin recouping costs while it is going through testing and approval process for other populations. And certainly putting this out for women first makes sense from economic and health perspectives because they are at highest risk for effects of the virus.
Also, epidemiologically it’s not impossible that vaccinating all females would reduce the disease prevalance greatly or even come close to eradication; but I really don’t know enough about transmission (male to male transmission through homosexual activity, for example) to know if that would be the case here.
I think the vaccine is a great thing, and should be encouraged. However, the clinical trial size is simply too small to begin to reasonably talk about mandatory anything – let it run for 4 years and collect adverse events, and then we’ll see whether mandatory makes any sense.
Drug companies are too aggressive in their marketing for specific products like this. I know they dropped millions upon millions to produce it, but their attempts to ram it down the states throats sends up warning flags to me for some reason. It is still in the early stages, and this company has had recalls before. The idea of a drug company having enough pull to make one of its products required is somewhat chilling, I’m glad they have backed off.
C Stanley, do you mean eradicating Cervical Cancer, or HPV? The human papilloma viruses (HPVs) are a group of more than 70 different types of virus. I think Gardasil only works on 4 strains right now.
Even if they immunize all 11-12 yr olds now, we won’t see results for 10 years at least, maybe longer. Think about it, if they started having sex around 18, it may not show up for them until in their mid 20s and possibly later, or never. I don’t think this is the silver bullet to the HPV issue, nor the cervical cancer issue. If they can get to say, 20 strains, then yes I see it having a huge effect, but not until then.
Jim B,
I was only speaking theoretically about how vaccines work. You’re right that this disease is more complex than a single strain virus, so my comment would apply only to potentially eradicating this one strain of the HPV virus. I was only making the point that IF it is not transmitted from male to male (and I don’t know if that is true or not), the theoretically the prevalance level would drop precipitously if all females in the population were vaccinated. That still assumes 100% efficacy in vaccinates, etc…so I’m doubtful. But it separates these issues from the issue of whether or males need to be vaccinated in order to acheive the desired result.
CS, that is what I figured you were getting at. If they can get it to work for males, I would think it could substantially cut down on the transmission. Hopefully this is just a stepping stone, and more strains will be included as they get further along in testing.
I stand by my declaration before, that IF I had a daughter around 11, I’d probably wait until she was 16 or so. Merck has some skeletons in their recent closet, I think this needs some time in the real world before being pushed out too hard.
I do know they are using it in Australia, of course they are subsidizing it substantially for their citizens. So in 3-4 years I think we may see a big leap in the capability of the drug, OR maybe its ineffectiveness.