NYTimes: Gardasil researcher criticizes the aggressive marketing of the vaccine

[pnwmom]

This is a long, detailed article about the marketing push behind Gardasil, the costs and potential benefits, including many points of view. The whole article is well worth reading.

http://www.nytimes.com/2008/08/20/health/policy/20vaccine.html?_r=1&hp&oref=slogin

In two years, cervical cancer has gone from obscure killer confined mostly to poor nations to the West’s disease of the moment.

SNIP

“Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now,” said Dr. Diane Harper, a professor of medicine at Dartmouth Medical School. Dr. Harper was a principal investigator on the clinical trials of both Gardasil and Cervarix, and she spent 2006-7 on sabbatical at the World Health Organization developing plans for cervical cancer vaccine programs around the world.

“Because Merck was so aggressive, it went too fast,” Dr. Harper said. “I would have liked to see it go much slower.”

In receiving expedited consideration from the Food and Drug Administration, Gardasil took six months from application to approval and was recommended by the C.D.C. weeks later for universal use among girls. Most vaccines take three years to get that sort of endorsement, Dr. Harper said, and then 5 to 10 more for universal acceptance.

“In that time, you learn a lot about safety and side effects and how to use it,” Dr. Harper said. “Those getting it early should be the ones who really want it and willing to accept the risk.”

SNIP

Cervical cancer is the second-leading cause of cancer death in women, with 500,000 new cases worldwide each year. But more than 90 percent of them are in developing countries, according to the World Health Organization; 274,000 women died of this cancer in 2006, nearly 95 percent in developing countries.

Where there are Pap smear programs, few women die of cervical cancer. In the United States, it is responsible for 12,000 new cases a year and 3,600 deaths, most in women who did not get Pap smears, said Laurie Markowitz, head of the HPV working group at the C.D.C. (Women with H.I.V. are predisposed to the cancer.)

SNIP

[mzmolly]

1. K and R'd

Thanks. :hi:

[Name removed]

2. Deleted sub-thread

Sub-thread removed by moderator. Click here to review the message board rules.

[WillYourVoteBCounted]

3. "Where there are Pap smear programs, few women die of cervical cancer."

Everyone should be able to get pap smears, but those of us without insurance
and in this cruddy economy can not.

They probably cost a lot less than a set of 3 vaccines, plus boosters in 3-5 years.

And if you don't have regular pap smears, you should not risk this vaccine at all,
since it can make HPV infection worse if you already have it.

[WillYourVoteBCounted]

4. "pressure on policymakers worldwide to introduce the HPV vaccine in national or statewide vaccinatio

From the New England Journal of Medicine today:

In the meantime, there has been pressure on policymakers worldwide to introduce the HPV vaccine in national or statewide vaccination programs. How can policymakers make rational choices about the introduction of medical interventions that might do good in the future, but for which evidence is insufficient, especially since we will not know for many years whether the intervention will work or — in the worst case — do harm?

http://content.nejm.org/cgi/content/full/359/8/861

[mhatrw]

5. kick. n/t

[Hannah Bell]

6. Here's another thing which suggests this vaccine was rushed to market:

"Although it was licensed for use in the United States in June 2006, the first phase 3 trials of the HPV vaccine with clinically relevant end points — cervical intraepithelial neoplasia grades 2 and 3 (CIN 2/3) — were not reported until May 2007"


Results not announced until 1 year after licensing: why?