Tuesday, February 06, 2007

Gardasil: To Be Mandatory or Not To Be Mandatory -- That is the Question

Won't anyone defend Merck's campaign to mandate the vaccination of school girls with Gardasil?

Even fellow blogger and industry supporter Rich Myer over at World of DTC Marketing claims this issue "is a prime example of what's wrong with pharma and adds to the public perception that pharma is only in it for the money" (see "A prime example of whats wrong with Pharma (Gardasil)").

The brouhaha over Gardasil was heightened when Texas Republican governor Richard Perry signed an executive order requiring school girls to be vaccinated with Gardasil (see "Texas Gov. Orders Anti-Cancer Vaccine" and "Texas vaccine mandate draws GOP ire").

You would think that vaccination against a form of cancer would be a no-brainer. Maybe I am too close to this. We lost a very dear friend to ovarian cancer. She was only thirty-something, had two small daughters, and was literally a saint (that's how she was eulogized by the priest at her funeral).

I am on record saying how courageous I thought Merck was in bucking the religious right who claim that vaccination against HPV will promote promiscuity (see "Merck On a Roll").

Aside from the promiscuity red herring, there are a few other issues with mandatory vaccination that critics raise, including:
  • It's too expensive (see World of DTC Marketing for a discussion of this issue).
  • It's not covered by all insurance plans (neither was Viagra in the beginning, but you didn't hear about male promiscuity).
  • The risks are unknown.
  • Merck is engaging in "Astroturf" grass-roots support efforts through an organization called Women in Government, mostly composed of state legislators and pharma companies.
  • Collusion of the governor with Merck lobbyists
I am not going to comment on all these issues except for the risk issue. I flatly dismiss the promiscuity argument and refuse to even discuss it. You can read The Pharma Blogosphere tomorrow for a synopsis of all the blog chatter on the other issues.

Risk and Lobbying
Ever since Vioxx was removed form the market, drug risk has been a hot topic and lightening rod for criticizing the drug industry. But let's not forget that the main problem in the Vioxx case was the fact that Merck had a campaign to hide the risks it knew about and "dodge" the issue.

We now hear the mantra that "all drugs have risks" and this is certainly true. Patients need to know the risks as well as the benefits and be able to make an informed decision. The problem is when their trust is shattered by industry cover-ups. Hopefully, this won't happen with Gardasil.

If you are my age, you remember being lined up for polio shots in school. There was no choice -- I am not even sure parents could have opted out of the vaccinations on religious grounds as they can in the case of Gardasil vaccination in Texas. And there was never any discussion of risk then.

Unfortunately, I don't think anyone has enough knowledge of what the risks are with Gardasil and the polio vaccination experience may serve as a warning.

So, maybe it's not a good idea on the grounds of unknown risk to force mandatory vaccinations at this time. Merck, therefore, should back off from lobbying states to make it mandatory.

That's my opinion. What's yours?

Should Merck Press on for Mandatory Vaccination?
Absolutely not!
Yes, but not through aggressive lobbying
Yes, take out all the stops!
Not sure


  1. This Gardasil mandatory vaccination issue is one of the most interesting things to crop up on the contemporary pharma scene. It has global ramifications. Imagine if you get the Gardasil compulsory vaccination programmme in India, where you have millions of prospects.

    This issue ought to be dealt with seriously by neutral bodies such as WHO, doctor associations to review the data and take an optimal decision. It ought not to be an issue of business or political interest alone.

    In India the Govt. appoints a consultative commitee to go in to such big decision making processes. Bodies like Indian Academy of Paediatricians and academic institutions debate on it for a long time before coming to a conclusion.

    A very responsible & conservative marketing approach is required on mandatory Gardasil vaccination issue. www.pharmaceuticalshealthcare.blogspot.com

  2. Anonymous2:52 PM

    I don't know whether your recent spat with CafePharma has helped to improve the editorial tone there, but I came across this reasonably intelligent "man in the street" -type discussion on just this topic at the cafepharma AZ company board. Not bad at all for CP...

  3. One only hopes that I had a positive influence. Warning: If you go there, make sure you wear protective clothing, hold your nose and DON'T drink the water!

  4. Anonymous11:27 PM

    Just found
    link to Texas Medical Association's position on Gardasil
    . It seems that they don't agree with making Gardasil mandatory.

    Incidentally, you mentioned that you are close to it because of a friend who died of ovarian cancer. But Gardasil doesn't prevent ovarian cancer. It significantly reduces the risk of cervical cancer, but so do regular pap smears. Cervical cancer is rare in the US with most cases being in women who hadn't had pap smears within 3 years of the diagnosis. To me the major advantage of Gardasil (provided it is safe) is that it significantly reduces the number of abnormal pap smear results - and there are quite a lot of those. Less anxiety and more importantly less treatment for hyperplasia which is not pleasant and may affect fertility.

    But while this may be a good argument for choosing to vaccinate one's own children, it is not a reason for making it mandatory. I think the TMA website has a pretty good explanation of why.

  5. Thanks Kitty for pointing out my mistake re: Ovarian vs. Cervical. Perhaps Merck needs to do more disease awareness/education advertising instead of branded Gardasil ads.

  6. Anonymous3:04 PM

    1. Is it safe?

    2. Is it effective?

    3. If 1 and 2, then informed consent on a voluntary basis is the only approach which guarantees compliance with law and fundamentally with our constitution.

  7. Anonymous11:01 AM

    In India, Indian Immulogicals, Shanta Biotechnics are working on the generic versions of HPV vaccines. How about that?


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