Friday, June 09, 2006

FDA Approves First Vaccine Against HPV, Leading Cause of Cervical Cancer

The FDA approved Merck's Gardasil vaccine today, which is intended to prevent infection with human papillomavirus strains that have been shown to cause cervical cancer, precancerous lesions, and genital warts. The vaccine was approved for use in women aged 9-26 years, and is expected to cost $120 for each dose in the 3-shot regimen, for a total of $360. According to Merck's website, the company "has created a new patient assistance program for vaccines. Through this new program, Merck will provide free vaccines to adults who are uninsured and who are unable to afford vaccines. Merck vaccines, including GARDASIL, will become available through this program in the third quarter of 2006."

Coverage of the story:
  • FDA Press Release
  • Merck Press Release
  • New York Times, and another
  • Washington Post
  • National Cancer Institute Press Release
  • Women's Bioethics Project 1 and 2
  • And Now, the HPV Vaccine - Slate
  • FDA OKs first cervical cancer vaccine - CNN
  • Nuns, Cows and the Cervical Cancer Vaccine - Medgadget (and related press release from Rochester Medical Center)

    Related Resources:
  • HPV Fact Sheet - National Cancer Insitute
  • Gardasil Questions and Answers - FDA
  • HPV Vaccines for Cervical Cancer - National Cancer Institute
  • HPV Vaccine Questions and Answers - Centers for Disease Control and Prevention
  • Human Papillomavirus (HPV) Infection - Centers for Disease Control and Prevention
  • Make the Connection - this site, sponsored by Merck, provides information on the HPV/cervical cancer connection. And, hey, you can get a free bracelet (which is not made out of rubber).

    Also:
    In searching for resources on this topic, I came across this post (pretty high up in the Google results) disparaging the vaccine as "worthless" and "potentially dangerous." Says the author, Dr. Mercola: "By the way, Gardasil is completely worthless if you already have one of those viruses. The other bad news: Five women treated with Gardasil near the time of conception eventually had children who now suffer from birth defects, a problem for which Merck denies responsibility." Vaccines are intended to prevent infection with a virus, not to treat those who already have a virus, by definition. As to the second point, I haven't read through all of the trial reports, but the product labeling (PDF) states:
    "During clinical trials, 2266 women (vaccine = 1115 vs. placebo = 1151) reported at least 1 pregnancy each. Overall, the proportions of pregnancies with an adverse outcome were comparable in subjects who received GARDASIL and subjects who received placebo. Overall, 40 and 41 subjects in the group that received GARDASIL or placebo, respectively (3.6% and 3.6% of all subjects who reported a pregnancy in the respective vaccination groups), experienced a serious adverse experience during pregnancy. The most common events reported were conditions that can result in Caesarean section (e.g., failure of labor, malpresentation, cephalopelvic disproportion), premature onset of labor (e.g., threatened abortions, premature rupture of membranes), and pregnancy-related medical problems (e.g., pre-eclampsia, hyperemesis). The proportions of pregnant subjects who experienced such events were comparable between the vaccination groups. There were 15 cases of congenital anomaly in pregnancies that occurred in subjects who received GARDASIL and 16 cases of congenital anomaly in pregnancies that occurred in subjects who received placebo. Further sub-analyses were conducted to evaluate pregnancies with estimated onset within 30 days or more than 30 days from administration of a dose of GARDASIL or placebo. For pregnancies with estimated onset within 30 days of vaccination, 5 cases of congenital anomaly were observed in the group that received GARDASIL compared to 0 cases of congenital anomaly in the group that received placebo. The congenital anomalies seen in pregnancies with estimated onset within 30 days of vaccination included pyloric stenosis, congenital megacolon, congenital hydronephrosis, hip dysplasia and club foot. Conversely, in pregnancies with onset more than 30 days following vaccination, 10 cases of congenital anomaly were observed in the group that received GARDASIL compared with 16 cases of congenital anomaly in the group that received placebo. The types of anomalies observed were consistent (regardless of when pregnancy occurred in relation to vaccination) with those generally observed in pregnancies in women aged 16 to 26 years."
    Do you see what that's saying? Rates of complications were basically the same between the vaccine and placebo, except when the vaccine was administered 30 days or less from the onset of pregnancy. This is actually not that uncommon - I received an MMR vaccine recently was told in no uncertain terms that I was not to get pregnant for a month. It's a complication worth noting, but could presumably be significantly reduced by educating women at the time of vaccination. It turns out that Dr. Mercola has "natural" medicine wares to sell - here's the FDA's warning letter to Mercola with regards to misleading claims about some of his products.

    Previous Related Posts:
  • Women's Health News: FDA Committee Recommends Approval of HPV Vaccine
  • Women's Health News: HPV Vaccine Moves Closer to Approval
  • Women's Health News: Status of HPV Vaccine and Cervical Cancer Prevention

    Technorati Tags: ; ; ; ; ;
    MeSH Tags: Papillomavirus, Human; United States Food and Drug Administration; Uterine Cervical Neoplasms/prevention and control; Vaccines
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