Gardasil in India: the real issue. Why don’t we women insist on informed consent?

Gardasil Side Effects

by Kristin Johns

April 13, 2010

Last week’s flap over the suspension of the Gardasil vaccination program in India left many people shaking their heads. While four girls did indeed die post-vaccination (although not immediately post-vaccination) and some side effects, including epilepsy, were reported, the Indian Council of Medical Research (ICMR) has concluded that none of the deaths were due to the vaccine. Two deaths were due to poisoning, or suicide, they said; a third was due to drowning, and the fourth to pyrexia (fever) of unknown origin.

Naturally the average mind is going to throw up a few warring questions about the motivations and actions of both those promoting the program and those—families and activists—who are calling for a halt to it. But it’s India. We may never know what truly happened.

The risk/benefit scenario for Gardasil

But here’s the thing. In the US, if a woman follows an intelligent, conscious lifestyle, the risks of the HPV vaccine probably outweigh the over-hyped benefits. In India, the risk/benefit scenario is entirely different. Cervical cancer is the number one cause of death for Indian women; the disease burden is huge. Although a cheap, low-tech test involving vinegar could save more than 100,000 lives annually if funded, the stark reality is that it isn’t. The likelihood that all those women will get this test every year or two over decades is remote; it’s even more unlikely that the government will get truly serious about cervical cancer by promoting regular Pap smears and HPV tests for all women.

Despite the fact that India’s status as a fabulous medical tourism destination (see here) has spawned excellent hospitals that legally must, and do, also give health care to indigent Indian citizens; despite the fact that India’s government is using boom money to try to alleviate the truly dreadful living conditions of many of its citizens—well, many women just don’t have regular access to health care.

Even though HPV vaccines do not appear to be nearly as effective as they’re made out to be, vaccination would almost certainly be worthwhile for those women. Shame on activists like Brinda Karat for not considering the facts.

Informed consent

What Karat did get right is the ethical issues of informed consent—and those issues are no less important here.

According to Karat, Gardasil was dramatically oversold to the impoverished “tribal” girls and their parents. Some of the participants in the trial didn’t even understand the language used in the pamphlets and by the administrators.

“The process of licensing the vaccine in India raises many serious questions,” she further contended at a press conference, “as time and again scientific logic and the ethical guidelines have been violated at each step.

“Our law clearly states that no trials of drugs can be conducted among children before trials are conducted on adults, and the vulnerable sections of society cannot be used for human trials.”

It’s a little tenuous to suggest that Merck was experimenting on particularly vulnerable sections of society this time around, given that Gardasil has been approved for use in many developed countries since 2006. But that informed consent thing? Spot on. And it’s true in the US, too.

I’m tired of women being treated, and allowing themselves to be treated, like complete idiots. A good doctor should lay out the facts—this is what HPV is, this is how the immune system deals with it, this is how your lifestyle affects your immune system, this is what happens when the immune system DOESN’T get rid of HPV. This is what the vaccine can and can’t do. This is how effective it’s been so far (17-45 percent in preventing cervical abnormalities from all strains of HPV). These are the known side effects, these are the ones that are reported but not proven.

Just tell us the damn truth. Many of us will decide that the potential benefits outweigh the possible risks. Some will decide the opposite. Some will choose to do whatever the doctor recommends. But whatever we decide, we’ll be making an honest, informed, choice. Don’t we deserve that? And shouldn’t we demand it?

For more info about pros and cons, see here .

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Brilliant article – Kristin raises a good point – if we do not have informed consent – how can we make informed decisions…..?

PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.