Pamela A. Popper, Ph.D., N.D.

Wellness Forum Health

In January of this year (2016), the American College of Pediatricians issued a statement expressing concern about the Gardasil vaccine. The article starts with the statement that the organization is committed to the use of vaccines as a tool for preventing disease, which means that this organization must have reason to believe there are issues associated with the vaccine in order to justify making its concerns public.

The reason for the concern is the potential association between the vaccine and premature ovarian failure, or premature menopause. The ACP article cites two published case report series in which adolescent girls developed laboratory-confirmed POF after receiving the Gardasil vaccine. The article notes that while events following vaccines are not always caused by vaccines, there are many legitimate concerns about this one. Long-term ovarian function was not measured in either animal or human vaccine trials for Gardasil, but potential mechanisms of action have been identified, which include autoimmune reactions due to the aluminum adjuvant used in the vaccine. Ovarian toxicity in rats has been documented for polysorbate 80, another adjuvant use din vaccines.

Since Gardasil was licensed in 2006, there have been over 213 reports of amenorrhea, POF, and premature menopause made to the Vaccine Adverse Event Reporting System, 88% of which were associated with Gardasil. There were no cases of POF or premature menopause and only 32 cases of amenorrhea reported to VAERS between 1990 and 2006 when the vaccine was approved. When VAERS reports were narrowed down to cases in which amenorrhea occurred with no identifiable cause, 86 out of 89 cases were associated with Gardasil.

An additional concern is that the problem may be much bigger than the reports show. Primary care doctors may not be aware of this potential association and therefore not report POF or prolonged amenorrhea to VAERS.

The ACP reports that there were flaws in the clinical trials that might have kept the association between Gardasil and POF from being identified, including the addition of polysorbate 80 and aluminum to the placebo. Also, a significant percentage of the girls were taking hormonal contraceptives which can mask ovarian dysfunction and which would have prevented an increase in amenorrhea or ovarian failure in the intervention group during the trials. More recent studies looking at Gardasil safety are plagued with the same problems. Based on these facts, the ACP says, a causal relationship between Gardasil and POF cannot be ruled out.

The author, Scott Field M.D., reports that a study is planned to address concerns about the relationship between Gardasil and POF, but it will likely be many years before results will be available. Furthermore, the study may not completely resolve the issue since sometimes ovarian dysfunction presents as months of amenorrhea and then progresses to POF much later on.

In the meantime, Dr. Field has asked Merck (the company that makes Gardasil), the Advisory Committee on Immunization Practices, and the FDA to make known these concerns, and to conduct more rat studies looking at this issue. He has also asked that the CDC review the VAERS reports, and that primary care providers be notified of the possible link. He concludes by saying that his organization is posting the statement because physicians and patients should have access to this information in order to make informed choices.

I’m encouraged that the ACP is speaking out about this issue and that it is demonstrating some respect for the rights of doctors and patients to have accurate information. This statement would be terrific if POF and premature menopause were the only side effects of Gardasil. But thousands of adverse reports concerning Gardasil have been filed, many of which have reported much more serious events, including death.  A comprehensive informed consent decision tool for Gardasil would include a summary of all of these events, as well as the lack of data demonstrating efficacy for the vaccine. All medical authorities recommend that women continue to have regular PAP tests, even if they have received the Gardasil vaccine, since there are no data showing that the vaccine actually reduces the incidence of cervical cancer, or risk of death from it. Avoiding death from cervical cancer is still dependent on early detection of abnormal cells with PAP tests, which calls into question the usefulness of the Gardasil vaccine.

Scott S. Field, MD “New Concerns about the Human Papillomavirus Vaccine.”
American College of Pediatrics January 2016