Monday, 14 May 2007

The dilemma which was Gardasil

Vaccines are wonderful gifts from God to the human race. I recall my parents telling me stories of dealing with whooping cough and of knowing kids with polio complete with stories of the "iron lung". I am amazed at the recollections of my colleagues who diagnosed Haemophilus influenzae meningitis numerous times a year during their training. I have never seen a case of it because I began my training several years after an effective vaccine was introduced.

There is now a vaccine on the market called Gardasil which protects against human papillomavirus (HPV), a leading cause of cervical cancer, and suddenly I find myself questioning moral and ethical decisions related to this vaccine. I do not have an issue with the vaccine per se since its use may be lifesaving for some women. The issue I have stems from Merck pharmaceuticals (the manufacturer) and its advertising methods and lobbying efforts. This vaccine was being advertised in numerous magazines (including some full page ads) and on television before I had been detailed about the vaccine by Merck. I received telephone calls from parents requesting the vaccine before I had even considered using the vaccine. Then I heard of Merck lobbying state governments in Virginia and Texas into mandating Gardasil use for school aged girls, and I had still never been detailed by the company. The doctors who would be administering the vaccine were skipped over, and the vaccine was directly marketed to consumers and the government.

The vaccine is recommended for girls and women ages 9 to 26. This means I am going to have to counsel pre-teen girls that they are getting a vaccine which protects against a virus that is transmitted through sexual intercourse. Did Merck consider this while they were lobbying the governors of Texas and Virginia to mandate this vaccine's use? Did they consider the parents who might just not be ready to open that discussion with their pre-teen daughters?

Ultimately I believe Gardasil is a good thing. Unfortunately its manufacturers crossed the fine line between altruism in medicine and profit. Thankfully, the company has finally detailed me on the use of Gardasil and given me the opportunity to voice my concerns. They assure me the lobbying efforts have stopped, but trust has been compromised between me and my colleagues and the company which provides the vaccine. When push comes to shove, I will and must put the concerns and needs of my patients and their families above the financial interests of pharmaceutical companies.


mhatrw said...

To summarize this published medical journal article:

1. In the FUTURE I trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 2 and grade 3 cervical intraepithelial neoplasia and adenocarcinoma -- the only recognized precursors to cervical cancer.

2. In the larger FUTURE II trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 3 cervical intraepithelial neoplasia and adenocarcinoma -- the strongest (and many would argue only valid) precursors to cervical cancer.

3. Extrapolating from GARDASIL's very limited clinical "success" (in the FUTURE II study only) against grade 2 cervical dysplasias (40% of which regress spontaneously), 129 women would be have to be vaccinated (at a cost of about $60,000) to prevent a single grade 2 cervical dysplasia.

4. GARDASIL's protection against cancer associated HPV strains 16 and 18 appears to cause a disproportionate increase in of pre-cancerous dysplasias associated with other HPV strains associated with cervical cancer "raising the possibility that other oncogenic HPV types eventually filled the biologic niche left behind after the elimination of HPV types 16 and 18."

5. Even if look only at the FUTURE II results (in which for some reason GARDASIL performed better among the general female population), we are talking about just a 17% decrease in all high grade dysplasias -- many of which would spontaneously regress without treatment. So we would have vaccinate 129 women (at about $500 for the three shot regimen) to avoid a single, eminently treatable dysplasia. That's about $60,000 per dysplasia prevented.

This is all directly from the article linked above.

I myself would add that we currently have only 3 years of follow up to go on in terms of both GARDASIL's safety and efficacy among the 16 to 26 year female population, no data concerning its efficacy among 9 to 12 year old girls and only 18 months of follow up on less than 600 total preteen girls in terms of safety data about GARDASIL within its targeted population.

See also: JAMA

It appears that the vaccinated cohort sees a 20%+ increase in high grade cervical dysplasias caused by cancer-associated HPV strains other than HPV 16 and 18.

One possible explanation is that HPV 6 or HPV 11 infections are antagonistic to more dangerous HPV infections.

Aileen & Kevin said...

To the Poster: Would you care to revisit this post and update your thoughts on the topic. I am curious what your impression is now that Gardasil has been on the market for another 6 years since your last post. What does the new research indicate?