Saving the World or Making a Buck

On June 8, 2006, the Federal Drug Administration (FDA) approved the drug Gardasil, manufactured by Merck & Co., for Vaccination in females 9 to 26 years of age for prevention of the following diseases caused by Human Papillomavirus (HPV) Types 6, 11, 16, and 18:

• Cervical cancer


• Genital warts (condyloma acuminata)


• and the following precancerous or dysplastic lesions:


• Cervical adenocarcinoma in situ (AIS)


• Cervical intraepithelial neoplasia (CIN) grade 2 and grade 3


• Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3


• Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3


• Cervical intraepithelial neoplasia (CIN) grade 1

Looks like a fantastic drug, all members of the female persuasion between the ages of 9 and 26 should make an appointment with doctors tomorrow to get the vaccine.

I'm not a doctor or research scientist, but I do try to stay informed about current events and one of the biggest news makers is the Vioxx trials. Vioxx is a pain medication, also manufactured by Merck, that was removed from the market after it was determined that it caused a high incidence of heart attacks. It is not unreasonable for me to express some concern about the risks associated with Gardasil.

So, what's causing all the little bell's to go off in my head?

According to an Associated Press article that was published on MSNBC.com, Merck is trying to convince state lawmakers to add the drug to the list of required vaccines for girls starting at age 9. With retail pricing at $360 per regimen, drug-industry analyst Steve Brozak of W.B.B. Securities is already estimating Merck should gross $1 billion per year, without any states requiring the drug be used. Should states start requiring it, that will add up to a lot of bucks for Merck.

In what is turning out to be a marketing war, the question is ultimately, is the drug primarily a cervical cancer vaccine or a vaccine against human papillomavirus (HPV)? Both are contracted through sexual activity, but only cervical cancer gives an appearance of being a disease that is not behavior related.

As a cancer vaccine, it is hard to argue against. As an HPV vaccine, one can make the argument that young women should not be involved in any sexual activity unless they are in a monogamous relationship.

Merck and its proponents of the drug are touting the cancer side of the drug, Merck even lists cancer as the first disease the drug prevents on its web site. But, Merck is trying to paint those against making the vaccine mandatory as religious conservatives who are only looking at the HPV side of the drug.

Along with the groups against making the drug mandatory, I am against it also. I realize the drug can protect against cancer, but let us also look at some of the other information we have.

The four major trials of the drug involved 21,000 women, ages 16-26. Although two trials were done of girls between the ages of 9 and 15, Merck has not released publicly how many girls were in those two trials and what there results were.

Most people are aware of the scientific method of testing, use a control group. In medicine, most of us tend to think the control group is going to take a placebo made of saline. In this case, the placebo was actually made of aluminium hydroxide which triggers an immune response, tainting the results.

Finally, remember, the manufacturer is Merck, who already has a recently tainted history with Vioxx. Plus, in their effort to push the drug, besides funneling money through different political action groups, they are also increasing the amount of money they are paying directly to politicians, nearly doubling the funds they are paying to Texas lawmakers, as one example.

I'm sorry, but I feel as though I can make a better decision about the health of my daughters than some money hungry decision maker at Merck. At a bare minimum, the drug should not be required until age 16, where the majority of the testing was done. Until we get more testing done, the drug should not be required at all.