Saturday, February 10, 2007

Compul$ory Va¢¢ination$?

"Up next on Fox 5 News at 10, learn why parents of young girls are upset about a plan to protect against cancer."

Recently, Shana's friend JL posted this entry. The quote above was an actual NYC news teaser last night on the same topic: Gardasil. Like JL, I also was recently ranting about the prospect of Gardasil becoming a compulsory vaccination.

Gardasil protects against four strains of HPV (Human papillomavirus), of which there are actually more than 100 strains. Common warts are caused by some HPV strains, and about a dozen strains cause various types of cancers. Gardasil protects against two strains that cause about 70% of cervical cancer. The other two Gardasil HPV strains cause 90% of genital warts. All four strains are transmitted through sexual contact. I think it is interesting that Merck's advertising focuses only on the cervical cancer aspect: "O-N-E L-E-S-S. I wan-na be one less, one less."

(If only the makers of Valtrex, Viagra, or Cialis were as discreet or ambiguous in their advertising ...)

The vaccination requires 3 doses, at $120 each. Merck stands to make a pretty penny, and it seems they have already bet the farm on it. Prior to FDA approval, Merck expanded a facility to accommodate Gardasil production, which is now operating 24-hours a day. Perhaps a risky bet, but the jackpot is huge: an estimated $2 billion dollar domestic market, and the estimate for the annual worldwide market by 2010 is between $4 billion and $7 billion. Of course, markets of this size are much more likely, and will materialize much sooner, if states and public health agencies mandate the vaccination.

Merck is working to make that happen by bankrolling groups like "Women in Government" who in turn encourage politi¢ian$ to make the vaccination mandatory. It has already brought results in Texas, where the Governor has mandated through executive order the vaccination of girls entering 8th grade by 2008. I am glad to see that he made the provision for parents to opt-out on religions or philosophical reasons. Other states are also considering legislation, probably with some help and ¢ontribution$ from "Women in Government." Merck is also (unsurprisingly) advocating "gender-neutral immunization," that is, immunizing both males and females. While I see that would immunize the male disease vector, I can't ignore the fact that it would also effectively DOUBLE the sales opportunity.

An estimated 290,000 women die each year from cervical cancer. But that statistic, while tragic, is deceiving - it's a worldwide number. Within the US, medical practice for the past 50 years has been to recommend and perform routine cervical cytology screenings (Pap tests). In that 50 years, the number of cervical cancer deaths has been reduced by 70%, currently about 3000-4000 cases annually. I respectfully acknowledge that statistic is also tragic. But why the push for compulsory vaccination withIN the United States, if 98% of the opportunity and benefit are OUTside of the US? I guess the statistical opportunity does not necessarily coincide with Merck's financial opportunity.

While a compulsory vaccination may help to further reduce the cervical cancer deaths in the US, by bringing it to those who neglect or cannot afford regular medical care, so too would improving the standard of care for those targeted groups.

A few years back, US public health agencies were sold on the Varicella vaccine. (That's Chickenpox for the rest of us). I was recently discussiong with the school nurse the rationale for vaccinating against a disease, that, in my experience, is a minor childhood disease. Apparently, prior to the vaccine, about 100 people died of Chickenpox annually. In an 18-month period in 2003-2004, the mortality had been reduced to eight. Something seems to be working with the Varicella immunization.

Unfortunately not everything is working. The lifetime immunity I acquired from my minor experience with Chickenpox at about four years old, has not been repeated with the vaccination. Children, despite immunization at one, have been catching the live virus when it comes around. Tests have indicated that within 5 years of immunization, reinfection may be as high as 8% and loss of antibodies may be as high as 30%. So now there is a Varicella booster administered a few years after the initial immunization. Did the pharmaceutical company fail to adequately test the vaccine and its effectiveness prior to marketing? Were we too easily sold when someone said the magic "vaccine" word? Does a vaccine always need to be compulsory for it to be effective? Will the drug makers provide the boosters for no additional charge? Or does this merely turn 40 million vaccinated individuals into repeat customers? I was tempted recently to arrange a pox party during an outbreak at school.

I don't think giving my child a shot against an STD will cause promiscuity - but I don't think we ought to wholly embrace and swiftly adopt everything labeled "vaccine" that drug purveyors provide us with. For some reason I am not convinced that my health and well-being is always the primary motivator of pharmaceutical companies. On the other hand, perhaps it is time to buy Merck stock.

For the love of money is the root of all evil ...

posted by Mark  # 12:10 PM

Comments:
I think this in an interesting topic of debate. While I don't agree with the mandatory vaccinations, I don't think that giving the vaccine equates with telling a pre-teen "go and be promiscuous."

Honestly, even the cost of the vaccination doesn't sound too bad compared to other medical expenses, including the costs (economic, physical, and emotional) of treating cervical cancer. And the fact that most cervical cancers are caused by HPV, which is sexually transmitted, hasn't stopped PAP smears from becoming a standard diagnostic. I'll bet you that the vaccine isn't nearly as uncomfortable to get as a PAP smear (I know, they aren't suggesting that the vaccine replace regular PAP smears).

Pharmaceutical companies, like all companies, need to make a profit in order continue to exist. What many people don't realize is the billions of dollars that need to be spent to get a single drug through the pipeline and to market. And even when drugs do get to market there's the complaint they haven't been tested enough to know all of their effects. True. Every treatment has a risk. The question to ask is whether the risk (whether real or perceived) outweighs the benefit.

I agree that some of the connections between pharma-interests and politicians are troubling, but again, I don't think that's unique to the pharmaceutical industry. I think that's more a problem with a political system in which he who has the most money wins.

 

Nicely written and good points. Same for the comment above. Thanks for the education!
Grandma Stout

 

Boss' OB doc in Iowa was one of the researchers for the vaccine, so I've been hearing about it for years. This vaccine in particular has a higher success rate than most and really does stand to be a hugely significant public health intervention. Whether or not it's worth the gazillions of dollars the public is going to have to pay is certainly debatable, but all of that is looked at carefully by departments of public health for cost/benefit. At least, that's what supposedly happens. How effective they are and how much politics and money get in the way, I can only guess!

 

Plus, Boss told me she heard on the news about the Texas governor having ties to Merck and being the first in line to make it a mandatory vaccination for Texans.

 

I'm not sure I have much to add, except to say that while I find the political ties to pharma-interests disturbing, I'm not sure I disagree with a mandatory vaccination. Like Peanut, I don't believe the vaccination will promote promiscuity, and I've also read a lot about the success rates they've had with this particular drug. No matter how small the risk of cervical cancer, I'd want my teen to be vaccinated. And if someone objects to the vaccination for whatever reason, it's possible to opt out, just like folks do now with our standard immunizations.

So... yes, it's a shame that certain groups may be taking advantage of this vaccination to make financial gains, but I don't think that negates that value of the vaccination.

Excellent post, by the way. Thanks, Mark!

 

Hi, it's Kathy's friend Jen...As a member of the health care community, I can see both sides of the issue. I think it is horrible how the drug companies jack up prices for medications and immunizations alike. However, I think that Gardasil should be added to the required vaccinations. Just because it is required, doesn't mean that somebody can't opt out. I have had several patients that don't immunize with the typical vaccines, and just have to sign a waiver. Just thought I would add my two cents.

 

Vaccines are typically not profitable enough to promote large pharmaceutical industry interest. I guess Merck picked the disease it pursued well - because instead of choosing an obscure disease it chose one with the cachet of being both a STD and a gender issue. This greatly increases the opportunity for profit. (For those who doubt the impact of these factors, compare the NIH research funding and death rates for AIDS and diabetes or Alzheimers, keeping in mind that AIDS has a similar STD and, um, 'minority', status.)

As Peanut pointed out, pharmaceutical companies are supposed to make money. It helps make sure that pharmaceutical companies continue to produce products we like to use. But that is part of the point - this disease is largely a personal choice. It does not ravage the population like a smallpox or polio. The choice for prophylactic care should be left to the consumer.

I object to marketing through lobbying for regulation. If the product is worth its price, it will be accepted without the lobbying. Selling something like this to a politician is like cheating the village idiot when you buy his cow- in both cases one party has trouble making proper cost-benefit analysis. Among the politicians not bought and paid for by pharmaceutical companies, which one is hot to be accused of condemning all his 10-year-old female constituents to a future fraught with fear of cervical cancer?

Vaccination in this case is bad public policy. At $0.7-1 million per death prevented vaccination would seem a decent investment, until the 50 year deferral on the death benefit is considered. Assuming 3% inflation and a 10% return for investing the money elsewhere in the economy, an outsized $20-30 million value per prevented death is required for vaccination to be reasonable.

Mandatory vaccination with Gardasil is poor public policy - even with an opt-out clause - because of the better use the money could be put to. If $2 billion/year is the right amount to allocate to this set of diseases, we would do better to spend the money to increase the intensity of screening, care, and focused research.
The current NIH annual budget is $27 billion. Total NIH annual funding for cervical cancer is about $96 million so it would be a huge increase in funding for cervical cancer. 50 years of investment here at that level could reduce the death rate by more than 70% well before 50 years from now.

Finally, $360 may seem an OK expense personally, but willy-nilly adding expense to the required/standard healthcare is part of what has led to the excessive growth of healthcare costs. To avoid this we must engage in real cost-benefit analysis, and not let the village idiots make our healthcare decisions for us.

 

When my daughter had her checkup this year, her pediatrician said she needed this vaccination along with a hepatitis vaccine. Both are new vaccines (hepatitis is new to the area and largely due to a flood of immigrants from Third world countries.)
They would not have given her either if I had not signed for them but I did spend a few moments in inner debate about the HPV vaccine. The deciding factor was the same reason I submit to a PAP smear every year even though I know that my behavior makes cervical cancer unlikely. Unlikely is augmented by another degree of protection and an opportunity to respond to the unexpected.
I must admitt that if the $360 price tag had been reveavled during the checkup, I may have chosen to skip it.
The general idea that vaccination provides a lifetime of complete immunity is an ideal that is rarely met in real life. The type of vaccine, how and when it is administered, the disease causing agent, and the immune health of the individual being vaccinated are all variables in the effectiveness of the vaccine.
One of the reasons for the success of small pox vaccinations in erradicating the disease world wide was the extraordinary effectiveness of that particular vaccine. It is not typical of most vaccines. In addition, even those of us who were vaccinated for small pox as children may not have complete immunity if we were challenged by the virus today. Even this exemplary vaccine requires a booster to maintain lifetime immunity.

 

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