Based on records obtained under a May 2007 Freedom of Information Act (FOIA) request, Judicial Watch has summarized the approval process, side effects, safety concerns, and marketing practices related to the human papillomavirus (HPV) vaccine Gardasil. It calls these a “large-scale public health experiment.”
One of the most startling findings is 78 cases of outbreaks of warts following the vaccine in women already infected without knowing it. Besides genital warts, some patients experienced massive outbreaks on the face, hands, or feet, sometimes caused by strains not included in the vaccine.
Additionally, the vaccine could increase the incidence of CIN 2/3 (cervical endothelial neoplasia in moderate stage) in women who had persistent infection with “vaccine-relevant” HPV strains at baseline. A chart in a report of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) showed an efficacy rate of –44.6% (that’s a minus sign) in subjects already exposed to “relevant HPV types.”
On June 25, 2008, the FDA denied Merck’s application to expand marketing of Gardasil to women aged 27 through 45. The FDA refused Judicial Watch’s request for a copy of the letter to Merck, stating that it may be available under FOIA.
Merck also failed to win approval to expand the vaccine to more strains and has reportedly dropped plans to do so.
Most tests with Gardasil were done against an adjuvant-containing “placebo,” rather than a nonreactive saline base, possibly making the vaccine seem safer than it actually is.
In its report to the FDA, Merck noted that “it is not known whether Gardasil can cause fetal harm when administered to a pregnant woman.” It reported that 27% of pregnant women experienced an adverse reaction upon receiving the vaccine, and the Vaccine Adverse Event Reporting System (VAERS) contains 45 cases of spontaneous abortion following Gardasil.
A pre-condition for fast-tracking Gardasil was a requirement for a safety surveillance study, which will not be complete until June, 2009. Nonetheless, intensive marketing continues.
A total of 8,864 VAERS reports have been filed, including 38 of Guillain-Barre syndrome and 18 deaths, 11 occurring within one week of receiving the vaccine. Association, of course, does not prove causality.
Mandating HPV vaccine is a matter of the public good vs. private rights, states Alexandra M. Stewart, J.D., who worked under contract from Merck with the George Washington University Medical Center to study Medicaid coverage for HPV vaccine. The intimate mode of transmission is “a distinction without a meaningful difference”; therefore, legal precedents justifying mandates should apply to Gardasil, she writes (N Engl J Med 2007;356:1998-1999).
In an article that appeared in MedScape on July 26, and was quickly taken off the website, Diane Harper, M.D., a principal chief investigator in clinical HPV trials, was quoted as saying, “The side effects that have been reported are real and they cannot be brushed aside.” She suggested that physicians not vaccinate patients with personal or family histories of the more serious complications, which have included neurologic disorders, thromboembolism, and autoimmune conditions.
“The cause of recent complications remains a mystery and it is difficult to know whether they are linked to vaccines,” the article stated.
Two physicians, a cardiologist and a rheumatologist, say they regret their decision to immunize their 17-year-old daughter and will not encourage his younger daughters to receive the vaccine. After being vaccinated, their eldest went from being a healthy athlete to a chronically ill patient. He worries that other girls may be struggling with immune damage, feeling achy and unwell, but going undiagnosed and unreported.
Gynecologist Christiane Northrup, M.D., appearing on the Oprah Winfrey Show, told viewers that she wouldn’t advocate vaccinating her daughters, and that medical dollars were better spent elsewhere.
The FDA and CDC issued a joint statement reassuring the public and physicians of the vaccine’s safety.
MedScape was accused of “germ theory denialism” (apparently for suggesting that it might be fruitful to investigate how most patients successfully fight off HPV) and “antivaccination myths.” It was also criticized for having the “chutzpah” to run a poll on how physicians were reacting to the reports about adverse events and the FDA/CDC advisory, and the poll has apparently been pulled also.