The federal government is considering making Gardasil vaccination, made by Merk pharmaceuticals, mandatory for female immigrants applying for citizenship. These shots, which vaccinate against certain types of HPV related to potential development of cervical cancer, are not mandatory for U.S. citizens. So why are they mandatory for immigrants? The two most obvious reasons are:
- profit – women would have to pay out of pocket for these shots making a sizable profit for Merk (even if they subsidize the shots, the government/tax payers will be paying $360 or more per applicable immigrant to Merk)
- human subjects testing without IRB – altho Gardasil has already been approved by the FDA recent complications in patients using the drug, 3500 major complaints in a single year and 8000 since the approval, as well as multiple deaths, could indicate that more testing is needed. Why pull the drug off the market when you can study the results through a mandated population?
The reason for Human Subjects Review Boards is to protect people, particularly members of vulnerable populations, from research that causes harm. It seems to me that there are too many cases in which vulnerable populations have been officially or unofficially targeted for new reproductive technologies in order to perfect them after the fact. And while Gardasil is not a contraception it does prevent HPV strains that are STDs and impacts the working of reproductive organs.
Think about how many poor and incarcerated women were given IUDs in the 70s, even after they were known to be unreliable and possibly to cause painful complications? Women in my family were part of a class action lawsuit against IUDs by women, which they won. (The components used to make IUDs has since been changed to prevent some of the major complications of the past.)
How many poor, incarcerated, and differently-abled women were told they “had to have” depo provera? (At least two studies of the drug show clearly that coercion was involved in testing and that vulnerable populations were used to hide these facts. Some doctors have reported that post approval such targeting continued, ie continued testing without HSB.) Now Pfizer, the makers of Depo are being sued for allegedly not informing patients and doctors of major side effects. The Native American Women’s Health Education Resources Center, the Latina Roundtable on Health and Reproductive Rights, the National Women’s Health Network (NWHN), and the National Black Women’s Health Project all joined together to request that FDA impose a moratorium on Depo-Provera b/c their research showed it had not been proven safe before being approved, big pharma blocked their protests.
Merk had been actively lobbying to have states mandate the use of Gardasil, and were particularly successful in regions with high populations of youth of color. As one of the previous links show, Texas mandated Gardasil use with girls of color specifically in mind. It turns out that the former Chief of Staff of Texas Governor Rick Perry is now a Gardasil lobbyist. As the quote below shows, former Merk employees were also present on the FDA Board that approved Gardasil’s use. Texas’ mandate was removed as complications surfaced. New Mexico Governor, and former Presidential hopeful, Richardson vetoed a similar attempt in NM. NM has one of the most active CRACK chapters, a program that advocates the sterilization of drug addicted and incarcerated women, paying them if they consent to the procedure, but they won’t mandate Gardasil. Attempts to mandate in Ohio and Michigan in 2006 also failed. California is still considering mandating it for school entrance, it was last reviewed as a possibility on August 7, 2008. And Missouri has successfully required the shots as part of school entrance, subsidizing low income students for $360 fee for the shots. In total, 39 states were aggressively targeted by Merck lobbyists. While some may see this as a question of protecting children, this Washington Post articles rightfully questions what is being centered: profit or young girl’s health? The conclusion they come to is that Merck is letting one overshadow the other.
Lobbying also extended to Canada, where a Canadian Women’s Health report outlined some of the major problems with Merk’s aggressive campaigning including:
- cost outweighed benefit
- Gardasil does not vaccinate against all forms of cervical cancer
- women who are infected with the HPV strains that Gardasil vaccinates against may not develop cancer and therefore may not need a vaccine
- there is no evidence of the long term side effects of Gardasil making it hard to provide informed consent
One feminist mother was so concerned, she ran for Canadian local government on a platform of stopping distribution of Gardasil and what she felt was the influence big pharma was having on the safety of people being used for experimentation. (listen here)
This is part of what Bev Collins had to say when she announced her intentions to run:
It took 28,000 deaths before Pharmaceutical giant Merck & Co had to remove their arthritis drug VIOXX off the counters. They saw their market stocks plummet close to 27%, and they were fighting hard to keep themselves from falling further. Over 4,000 law suits were keeping them busy in the courts, while their scientists were manufacturing a new drug.
A new vaccine called “Gardasil” is out on the market. Manufactured by this same company, quickly fast tracked by the FDA in February 2006, and approved in September in the United States without many years of research or medical support behind it. Don’t you find it interesting that two of Merck’s own former biologists, Vaccine expert Dr. John Boslego and Alan Shaw, sat on this FDA panel that just happened to approve this Merck vaccine? (Black Krishna – scroll to 9/16/07)
These issues are no less salient in the US. While Gardasil may protect some women it is not necessary for many and mandating its usage is akin to mandating vaccination for a majority of non-exposed patients and/or patients that may need other treatment in the future while thinking they are now immune. It should be noted, that other immunizations are generally mandatory for school entrance and that Gardasil is being billed as part of this standard.
The CDC here in the US takes a less drastic view of the impact of Gardasil but still notes problems. It should be noted that their research helped isolate HPV as a major cause of cervical cancer and start the ball rolling on research that eventual led to the creation of two vaccines, Gardasil being one of them. France has also subsidized the shot as part of its health care plan. While Australia initially welcomed the shot, an internal study of the drug caused them to change their minds.
Now the government is debating targeting immigrant women with Gardasil, which is not a reproductive drug and thus marks expansion of these practices outward into women’s general health. As the BFP post linked above also shows, state government has already targeted children of color. And let us not forget that HPV is a sexually transmitted virus and that if your cervix is compromised so is your reproduction. Finally, a study of the adverse effects of Gardasil points to plans to extend its use to men for the sake of additional profit while its attempts to extend to women between the ages of 27 and 45 have been turned down (their statement about the rejection again includes issues of profit):
We view the age extension indication as an incremental commercial opportunity, but one where we would also expect a much lower penetration rate.
I know people who worked on the research that eventually led to the creation of Gardasil. And I believe that they had the best intentions about supporting women’s health and curing cancer in mind. Obviously, they had HSB/IRB approval. I do not mean to disparage their work by questioning this potential legislation. Instead, I’m trying to encourage some introspection on the potential for abuse on the part of the nation and big pharma at the expense of women post-approval, post-official research project(s). I’m trying to track a pattern, however loose it may be, of big pharma getting around HSB and returning to the very kinds of research that we swore would never happen again. When a marginalized population, in this case immigrant women, is singled out for mandated medical procedures that no other population is nationally mandated to undergo, we should be concerned.
It seems to me that we need to pay close attention to the ongoing connection between intentional use or coerced use (which a state or national law requiring use is) of vulnerable populations and medicine with known major side effects. We need to be concerned not only because of what it could say about how human subjects are once again rendered unwitting research subjects without HSB approval but also because of what this pattern says about the state’s growing interference in women’s bodies.
At a time when outcry about reproductive rights is so loud, I find myself wondering where is the similar outcry about medical testing targeting women who are members of vulnerable populations. Gardasil in particular seems to mobilize a feminist discourse to sell its product and the realities of this potential legislation forcing immigrant women to take medicine they may not otherwise take, and which non-immigrant women have not been universally forced to take, is antithetical to feminism which claims women should have sole control over their bodies. It is not about Gardasil, its effectiveness or lack there of (of which there is ample evidence in both directions), it is about women’s rights, women’s health, and women’s bodies. No matter how bad cervical cancer is, and as someone who has lost family members to cervical cancer I can tell you first hand it is bad, we cannot afford to sacrifice a woman’s right to choose what she does with her body based on her legal status, race, class, location, or any other marginalizing identity. Nor should we settle for a product that may not have been studied enough because it is all we have.
By making ourselves aware of the Merk example, we open our eyes to other potential examples. In so doing, hopefully we can stop what increasingly appears to be the use of human subject trials outside of actual clinical trials approved by HSB.
- for a quick list of vaccines tested on women and girls see here.
- for interesting conversation on similar themes (and much more succinct than me as usual) see Feminist Philosophers (make sure you read the comment section and the great links)
Tuskegee Syphilis Experiment 1933. National Archives. (The CDC page on Tuskegee emphasizes a timeline of papers published and medical breakthroughs and its narrative focuses on reparations instead of the atrocity . . . when I took the HSB exam for the first time I intentionally failed the question on Tuskegee b/c according to the computer the correct answer was not that Tuskegee was a horrible atrocity committed by racist scientists but that it was a sign of the need for strengthened ethics in research and a failure of informed consent. If race was not a factor, why were black men singled out for experimentation? And if the same people in charge of cataloging adverse reactions and protecting human subjects respectively can white wash Tuskegee like this imagine what else they can do in a world where most reproductive technologies are tested on third world women’s bodies with limited or no informed consent.)
The two speculums vintage medical image. The speculum was created hand in hand with slavery first as an instrument of force feeding on slave ships and then perfected for women’s health through a series of un-anesthetized experiments on enslaved women by J. Marion Sims “the father of women’s medicine” read a brief history here
stock photo. unattributed.
working class girl vaccinated at free clinic. unattributed.
“Digital Offering” El Rio.
stock photo. unattributed.
cover Global Feminist Bioethics. R. Tong