In plain English, there’s a single report of a 16 yo Australian young woman whose regular periods stopped up after having the vaccination. She consulted her doctor and after refusing hormonal medication, the condition was further investigated. After ruling out known causes of POF, the doctor concluded that Gardasil had caused her ovaries to cease functioning.
The case study, and the subsequent flurry of pro and anti vaccination responses on the internet, raises a lot of questions. After further research, I’m left with questions about both the doctor who raised the alarm and the pharmaceutical company making the drug. But first a closer look at the claims. My responses are in italics.
As quoted in the case study, the cause of 90% of cases of POF is unknown. The authors claim to have ruled out all known causes but in this case where 90% of causes are not known their conclusion is statistically insignificant. The connection asserted with HPV is casual at the very most.
Dr Deirdre Little, the doctor and co-author who drew the connection between Gardasil and this case of POF, is actively involved in the Christian Pro-Life movement. In the US there has been an active Christian lobby lead campaign to ban HPV vaccinations, claiming it will encourage promiscuity (no need to comment on how ludicrous that assertion is). While this doesn’t negate her claims, it does suggest a possible bias.
The authors approached the Australian Therapeutic Goods Administration to find out if Merck, the makers of the vaccine, had submitted any animal ovarian histology studies in support of Gardasil’s approval. Under Freedom of Information it’s claimed that Merck supplied only rat testes studies but no ovarian histology. Does this imply an oversight or a deliberate withholding of data by Merck? Pharmaceutical companies have a history of fudging data in support of some drug claims.
An emulsifier, Polysorbate 80, used in Gardisal is quoted in one article on the internet as “a known cause of ovarian deformities, degenerative follicles, hormonal changes, and womb and vaginal changes in rats”. The only medical study supplied to support the claim was published in 1993 and doesn’t appeared to have been replicated. As this ingredient is used in many influenza vaccines then I’d expect many more reports of the possible connection.
The authors claim that most adolescents presenting with no or scanty periods are usually prescribed hormones to mask the condition and are not investigated for possible POF, therefore many other cases may exist. This is possible.
The science behind the claim seems woolly at best. But on the other hand post-market surveillance of drugs, medical devices and vaccines in this country is riddled with under-reporting.
In this case, from extensive research into the lead author’s publishing history, it’s hard to not conclude that the doctor has an agenda regarding the ‘sanctity’ of fertility.
There is room for independent research into any possible suppression of ovarian function caused by the vaccine or it’s components. If any are found, then it is up to the regulatory bodies to decide if the connection is a rare or uncommon adverse reaction, or a statistically significant one.
According to US data POF occurs in approximately 1:1000 15-29 yo women. Is this just the tip of the iceberg? This figure certainly pre-dates the HPV vaccine, making it a condition that warrants greater research independent of this recent claim. Further more, there are no statistics on the percentage of adolescents who present with primary or secondary amenorrhea (no periods) being treated symptomatically with hormonal medication, without further medical investigation. Anecdotally, from over 20 years of practice in Australia, the majority of women I’ve seen who have a history of this condition have been treated symptomatically. It’s not until at a later age when they fail to conceive that causes are investigated. Statistically these women are missing from the data on young women with POF.
A single case report is rarely a cause for alarm. Even if eventually connected with the vaccine it’s possibly a rare or idiosyncratic reaction. However further animal studies into the vaccine, specifically ovarian histology, may be warranted.
That doesn’t mean I don’t have questions around the general safety of HPV vaccines but the publicity generated over the publishing of this case study doesn’t significantly increase my concern.
On another note, the most positive thing to come out of this could be a growing awareness of POF in young women. There’s certainly need for greater vigilance and research into causes of this condition.