Gardasil — Exempt from Truth in Advertising Standards?

People who ask questions about Gardasil are invariably told that they’re scientific ignoramuses, endangering their children with their crazy paranoia. Last week, however, JAMA, the Journal of the American Medical Association, issued stinging critiques of the over-selling of the HPV vaccine and the potential skewing of any risk/benefits analysis. It was rare criticism from the medical profession.

The truth is, we have more legal protection from an under-powered blender than we do from a vaccine.

Gardasil could well be the best thing since the invention of SmartPhones. But it could also alter our life for the worse, permanently, or it could simply be a waste of time and money. Merck and the FDA are making highly educated guesses, but you’d never know that from the hype. As consumers, isn’t it time we started demanding a little respect and honesty? Don’t we deserve sufficient information to come to a reasonable decision?

Under the Federal Trade Commission Act, advertising must be truthful and fair, and it must not deceive. Advertisers must have evidence to back up their claims. An ad is considered deceptive if it either contains a statement or omits information that might well mislead consumers who are acting reasonably under the circumstances. It also must not omit information that is important to a consumer’s decision to use or buy the product.

With Gardasil’s unprecedented marketing, said Drs. Sheila and David Rothman in JAMA, “by making the vaccine’s target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to adolescents was maximized, and the sub-populations most at risk practically ignored…the material [put out by Merck-funded PMAs] did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on the risks and benefits.”

Science can be defined as ‘what we know so far.’ Or as Dr. Charlotte Haug put it in her JAMA editorial about Gardasil, “medical knowledge is typically incomplete and ambiguous.” Often, what we think we know turns out to be wrong, or just the tip of the iceberg. It would be totally irrational to reject all medical science on the basis that we might find out something to the contrary later, but it is equally irrational to try to make a decision about a new treatment without being in possession of all the known facts, particularly when huge financial benefits to the vendor weigh in.

“GARDASIL is the only cervical cancer vaccine that helps protect against 4 types of human papillomavirus (HPV): 2 types that cause 70% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases,” says Merck. “Be one less,” say the ads. The implication: if you don’t get Gardasil, you do get cervical cancer.

Here’s my Truth in Advertising version.

Gardasil targets the two strains of the HPV virus that currently cause 70 percent of cases of cervical cancer and two strains that cause genital warts. Your chance of dying from cervical cancer is extremely small if you have regular check-ups. HPV may also cause (even more rarely) cases of oral cancer, anal cancer, and penile cancer. We do not yet know whether Gardasil will be effective against these cancers and will not know for several decades, but the hypothesis seems likely to some degree.

You can reduce your small chance of developing HPV-related cancers dramatically by eating healthy foods, by not smoking, by limiting your sexual partners, and by undergoing regular screenings. 95 percent of cases of HPV are currently shrugged off by the body. You should consider your lifestyle honestly when making a risk/benefit analysis.

Gardasil may offer some further protection. After 3.6 years, the results from two randomized, placebo-controlled trials following 17,622 women who were vaccinated with Gardasil after showing no previous exposure to 14 HPV types and had normal Pap smears to begin with were:

· 17 to 22 percent reduction in ASC-US: atypical squamous cells of undetermined significanceassociated with a high-risk type of HPV

· 17 percent reduction in LSIL: low-grade squamous intraepithelial lesion

· 36 percent reduction in ASC-H: atypical squamous cells/cannot exclude high-grade squamous intraepithelial lesion

· 45 percent reduction in HSIL: high-grade squamous intraepithelial lesion

Colposcopies were reduced by 20 percent, cervical biopsies by 22 percent and surgery and other invasive treatments by 42 percent.

Protection against genital warts appears to be extremely good.

We do not know whether replacement diseases will occur should non-vaccine strains of the virus (there are more than 100, and at least 15 are known to be oncogenic) fill the biological niche left by vaccine strains. We do not believe that this is likely but the vaccine Prevnar has shown that it can happen.

We do not know how Gardasil will affect natural immunity to the more than 100 strains of HPV.

We do not know how long immunity will last and whether single, or perhaps multiple, booster shots will be necessary. We do not know whether, should immunity to HPV-16 and HPV-18 wear off, older adults will be able to fight off the virus as well as younger adults.

Data from the passive VAERS system that is used to monitor vaccine adverse events, along with data from clinical trials, appears to indicate that Gardasil is well-tolerated by the vast majority of individuals. The FDA has determined a slightly greater risk of fainting and associated injury and of blood clots.

Anecdotal evidence and VAERS reports associate Gardasil with an increased risk of auto-immune disease and neurological problems, including rapid-onset ALS, arthritis, Graves Disease, paralysis, seizures, chronic headache, etc., predominantly in very active girls, but no causal link has been found at this time and incidence does not occur at a very significantly greater rate than in the general population. Incidence of auto-immune disease, which may be triggered in genetically pre-disposed individuals and more often in women by environmental factors, is generally rising. We do not know why. We do not know if a rapidly increasing lifetime burden of vaccine adjuvants plays some part, although high levels of aluminum have reportedly been found in spinal taps from some affected girls.

There was concern that initial studies of Gardasil showed a 44.6 percent increase in CIN 2/3 (the highest grade of pre-cancerous lesion) in a sub-group of individuals who had existing vaccine-type infections at time of vaccination. Further analysis showed that an unbalanced proportion of these subjects may have had enhanced risk factors such as a current smoking habit or a history of cervicovaginal infection or STD. Background evidence provided to the committee approving Gardasil concluded that, after balancing risk factors and sub-dividing sub-groups, vaccination could be said to reduce CIN2/3 by a modest 5.5 percent. Overall, a combined figure for subgroup studies showed an enhanced risk of disease of 11.7 percent in subjects who tested positive for vaccine-relevant HPV at the beginning of the study.

You may wish to get an HPV test and/or a pregnancy test prior to vaccination. You may wish discuss the advisability of vaccination with your doctor if you or your family has a history of autoimmune disorders.

You should not get Gardasil if you’re allergic to yeast or if you’re pregnant or planning to become pregnant soon.

You should report any and all potential adverse reactions to VAERS, being sure to include valid contact information, and not just all immediately post-vaccination allergic reactions, as the CDC’s handout implies.