HPV Vaccine: The Fine Print

Da 'Laxation Corner
Feb. 23, 2007

Yesterday, Jacque Reid, former BET personality, spoke about the newly approved HPV vaccine on the Tom Joyner Morning Show. Can I say I wasn't satisfied with the media's diluted version of the vaccine? And it surely didn't help that Sybil, one of the morning show personalities, seemed to give her approval of such a vaccine with no formal research?

Not one to allow the fine print to sit idle in the background, I shot off an e-mail to Tom at blackamericaweb.com. So far, I haven't received a reply, though, I really don't expect I will. We all know who writes the checks for these shows.

With that said, I decided to take another step or two: I sent the e-mail to friends and family in my address book and I'm also going to post it to my blogs. What I ask of you is that you pass this e-mail on to all you know. This e-mail could very well prevent the black and Hispanic women and girls in our lives from making the greatest mistake of their lives.

Pass it on, save a generation:

"Hello, Tom,

This morning Jacque Reid gave a report on the new HPV vaccine available to women and young girls. I think some important facts about this vaccine was left out, and I would like to share those points by e-mail since I was unsuccessful by phone.

Fact 1: The study was conducted over a four-year period, which means, with such a short study, we have yet to know the extent of any adverse reactions from the vaccine, especially the 250 girls around the age of 9 that were administered the vaccine and who have not yet reached the age where they're likely to be attempting to become pregnant.

Fact 2: It was noted in the FDA labeling: Carcinogenesis, Mutagenesis, Impairment of Fertility GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity. In other words, this vaccine could cause fertility problems down the line, but the drug maker is not sure. It could also, itself, cause cancer but they're not sure. See link for more information on the FDA's findings: http://www.fda.gov/cber/label/hpvmer060806LB.htm.

Fact 3: The pregnancy category for this vaccine is B. It is noted that it is not known whether Gardasil can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity.

Fact 4: Merck&Co. is so unsure about this that Merck & Co., Inc. maintains a Pregnancy Registry to monitor fetal outcomes of pregnant women exposed to GARDASIL. Patients and health care providers are encouraged to report any exposure to GARDASIL during pregnancy by calling (800) 986-8999.

Fact 5: When it comes to lactation, they're not sure either. According to the FDA's report: It is not known whether vaccine antigens or antibodies induced by the vaccine are excreted in human milk.

And more regarding the lactation that should concern those faced with the decision to vaccinate or not: Overall, 17 and 9 infants of subjects who received GARDASIL or placebo, respectively (representing 3.4% and 1.8% of the total number of subjects who were breast-feeding during the period in which they received GARDASIL or placebo, respectively), experienced a serious adverse experience. None was judged by the investigator to be vaccine related. How can we be sure it wasn't vaccine related, since it followed on the heels of the vaccine?

In clinical studies, a higher number of breast-feeding infants (n = 6) whose mothers received GARDASIL had acute respiratory illnesses within 30 days post-vaccination of the mother as compared to infants (n = 2) whose mothers received placebo. I think the first number is one worth consideration, don't you, especially since it was only evaluated over a four-year period?

Fact 6: The testing was carried out on more than 27,000 young men and women but only 250 of these subjects were as young as nine.

Fact 7: This vaccine has purportedly been shown to protect against four types of HPV--6, 11, 16, and 18--while there are over 100 strains of HPV. Does that make it worth it, even if these are said to be the most common types of the strain?

My concern about this vaccine also lies in the fact that it's with a certainty that low-income black and Hispanic women will be the largest populations targeted for this vaccine. Would you, Tom, if you had a nine-year-old daughter, put her possible reproductive future in your hands in this manner? Could you live with the consequences of knowing because of a vaccine you gave her 10 years prior, today, she cannot have children? The media have hyped this vaccine up to be the best thing for all women, but is it really? Or is it another failed drug hot on the trail of Vioxx, which, incidentally pounced out of Merck's laboratories, failed and changed lives forever?

Tom, as a well-known media personality, you could possibly save the lives of many "future" women and men. We owe it to those with lesser knowledge to research vaccines such as this for their efficacy and safety. We also owe it to our people to provide them with the information needed to make educated decisions about their future and the future of our children. This is one vaccine that neither of my daughters will be taking, mandatory or not. We'd rather take our chances with those 4 types. As far as reproduction goes, we'd stand a much better chance."