A story in today’s WSJ questions Gardasil’s efficacy:
But behind the scenes, Gardasil has been dogged by uncertainty about how effective it really is. Merck won approval for the vaccine based on research that showed it protected against two strains of the human papillomavirus, known as HPV 16 and 18, that are thought to cause 70% of cervical-cancer cases. The Food and Drug Administration didn’t ask its panel of experts advising on Gardasil to rule on whether the vaccine specifically prevented the cancer itself. In clinical trials, 361 of 8,817 women who received at least one shot of Gardasil went on to develop precancerous lesions on their cervixes within three years of vaccination, just 14% fewer than in a placebo control group.Scott Emerson, a professor of biostatistics at the University of Washington who sat on the FDA advisory committee, says he’s not persuaded the vaccine is worth the billions of dollars likely to be spent on it in coming years. “I do believe that Gardasil protects against HPV 16 and 18, but the effect it will have on cervical-cancer rates in this country is another question entirely,” says Dr. Emerson. “There is a leap of faith involved.”
Related posts:
- Going contrarian on Gardasil
- Poll: Should boys get Gardasil, the HPV vaccine?
- Gardasil: New Hampshire shows how it’s done
- The HPV vaccine for the prevention of anal warts
- Too much Gardasil hype
- More on mandatory Gardasil in Texas
- Now, that’s (lack of) faith
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Gardasil Vaccine: So far 3 deaths and 1,637 Adverse Reaction Reports to FDA
Opponents to Gardasil say things like:
“This vaccine should not be mandated for 11-year-old girls…. It’s not been tested in little girls for efficacy. At 11, these girls don’t get cervical cancer—they won’t know for 25 years if they will get cervical cancer. Giving it to 11-year-olds is a great big public health experiment.” Dr. Diane Harper, lead researcher, HPV vaccine development
Objections Listed:
1. The vaccine is costly. ($360 for series of three shots)
2. Lack of testing in 9–13 yr olds.
3. Lack of evidence of duration of protection (estimated duration of 5 years).
4. Efficacy has not been demonstrated and is unknown. In fact, there’s already been talk of the need for booster shots.
5. Benefit of Gardasil to 9–13 year olds is dubious. Cervical Cancer affects 45-55 year olds, 40 years later.
6. Questionable Safety when used in conjunction with other vaccines (Hep B and Meningitis ).
7. High rate of vaccine injury: the US Vaccine Adverse Event Reporting System is showing considerable serious injury from this vaccine, especially neurological and immune dysfunction. Included are reports of collapse, paralysis, Guillain-Barre syndrome, dizziness, vomiting, rash, syncope, seizures and headache.
8. Gardasil may actually cause an increase in cervical cancer due to a false feeling of security in the females who receive it and decline PAP smears.
9. Gardasil does not guarantee safety from HPV: Regular Pap screening tests with their incumbent costs will still be needed.
10. The incidence of cervical cancer is low, and it would cost $360 million to pay for vaccine to prevent only 1–2 deaths.
11. HPV is usually benign: The virus clears up on its own within 8–12 months.
12. Pap screening already works and has been very effective in reducing cervical cancer rates.
13. Gardasil gives the wrong message to kids about sex and may encourage promiscuity.
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Guard Your Daughter from Gardasil
Jeffrey Dach MD
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