Last Friday, the FDA approved the Gardasil vaccine for use in boys and men ages 9 to 26 years old. When I heard this news, I was surprised. My daughter received the vaccine from her physician, and I had always thought of this as a "cervical cancer vaccine." The reality, however, is that this is a HPV vaccine, to guard against the sexually transmitted Human Papillomavirus. Why, however, is it only now being approved for males, when it was approved three years ago for females?
I turned to Adina Nack, Ph.D., professor of medical sociology and sexuality studies at California Lutheran University, for answers. She is the author of the book Damaged Goods? Women Living with Incurable Sexually Transmitted Diseases (Temple Univ. Press, 2008), and her research on STI stigma provides insight into the negative health consequences of Merck's original campaign for developing and marketing a female-only Gardasil. In my email interview with her, she reflects on the recent news.
Why do you think Merck first sought FDA approval of Gardasil only for women?
Only going through the FDA testing and approval process for women allowed Merck to brand Gardasil as a 'cervical cancer' vaccine. Prior to the recent FDA approval of Gardasil for use on male patients, most Gardasil ads have claimed to empower girls and young women with a new tool to protect against cervical cancer. But, it is not clear how many Americans have understood that they were being sold a vaccine designed to protect against a STI.
In your book and blog posts, you talk about the stigma connected with sexually transmitted infections (STIs) being gender-based. How are attitudes about STIs reflected in the initial branding and marketing of Gardasil as a cervical cancer vaccine?
As early as 2005, some organizations have been outing Gardasil as a STI vaccine and arguing that inoculating young adolescents against HPV would encourage teenage sexual promiscuity. The heads of various "family values" groups publicly declared that they would not vaccinate their own children. So, some have questioned whether Merck's decisions to only seek initial FDA approval for female use and to brand it a 'cervical cancer' vaccine may have been motivated by a desire to distance the vaccine (and those who receive it) from the negative stereotypes we have about STIs and the types of people who contract them. On one hand, it is reasonable to assume that most U.S. parents would not be eager to have their daughters, as young as 9 years old, vaccinated against 4 strains of a virus that is primarily transmitted by sexual contact. After all, studies have shown that we're more likely to assign negative traits - like promiscuity, irresponsibility, naivety, and unintelligence - to girls and women who contract STIs than to boys and men who contract the same infections. The Council on Contemporary Families has a forthcoming study showing that, while equality has increased in many areas, sexual-behavior double standards persist. In the U.S. and many other countries, a female patient who seeks out a STI vaccine often has reason to worry that others will label her a 'bad girl' or 'fallen woman.' We are more likely to see a 'cervical cancer' vaccine as something that good girls and chaste women are justified in seeking out.
If this strategy might have increased the numbers of girls/women receiving the vaccine, then what is the problem?
It can be argued that the success of branding Gardasil as a cervical cancer vaccine has come with serious public health costs. How can we account for the boys and men who have been unable to legally access this for the last 3 years, a time period in which many of them (and their sexual partners) could have been protected against HPV-related diseases and cancers? Prevention and early detection is especially important for HPV infections because we do not yet have a true 'HPV test' or medical cure. By not seeking FDA approval for both male and female patients at the same time, this vaccine's potential benefit to the public was limited. The FDA's recent decision to approve male Gardasil has confirmed that Merck sold us a STI vaccine disguised as a cancer vaccine. Despite the messages in Merck's successful female Gardasil campaign, cervical cancer has never been the only reason to care about the HPV pandemic: medical studies have connected HPV to oral cancers and anogenital cancers in both female and male patients.
You have made the point that the Gardasil ad campaign was a primary source of HPV information for many who had not previously been educated about this STI - what do you see as the downsides to this?
By obscuring the fact that HPV is a STI in its marketing of Gardasil, Merck missed a chance to educate us about this highly contagious family of viruses: one can contract HPV from the types of skin-to-skin contact that can take place even when sexual partners are using barrier methods, like condoms or dental dams. Given the current trends in U.S. teen sexual attitudes and behaviors, I'm also concerned about how many young people are at risk for contracting HPV because they are engaging in oral sex or anal sex to remain a 'virgin.'There has yet to be a large-scale public health campaign to educate the U.S. public about the truth of HPV, so Merck's Gardasil marketing materials may have been the first (and sometimes only) 'education' about HPV for many Americans. For teens and young adults whose primary source of HPV information came from Gardasil ads, then what is the public health damage of not clearly understanding that HPV is sexually transmitted? What about not realizing that HPV can infect and have serious health consequences for boys/men?
Why do you see de-stigmatizing STIs as key to improving sexual health in the U.S.?
With Gardasil now fully unmasked as the HPV vaccine it has always been, I'm hopeful that we will stop believing the myths that HPV is only a concern for females and that only promiscuous people get STIs. The availability of safe and effective STI vaccines is something to celebrate. Gardasil's new approval for use by boys/men is an important opportunity to destroy longstanding myths. To de-stigmatize HPV is to stop viewing it - or any other STI - as a sign of immorality. Through my website, I receive emails every week from those whose genital HPV and herpes infections have damaged not only their health but also their self esteem, their relationships, and their social reputations. Eliminating the shameful stigma of STIs could free millions of infected women and men from social and psychological traumas and harm public health. Viewing these kinds of infections as medical conditions would allow STI patients to focus on pursuing treatment options that not only allow them to manage their own symptoms but also make them less likely to infect others. Destigmatizing STIs may also increase the odds that a newly diagnosed person will disclose their sexual health status to their sexual partner. New social attitudes and better public health education about STIs can prepare Americans to support future STI/HIV vaccination programs.
As a result of marketing Gardasil as a cervical cancer drug for girls and women only, scores of males and their partners have unnecessarily contracted HPV over the past three years; the full range of health consequences of HPV have been ignored, and stereotypes and stigmas around STIs remain entrenched. Astoundingly, the American Social Health Association reports that "about 5.5 million new genital HPV cases occur each year -- this is about 1/3 of all new STD infections." Clearly, what we need is open and honest education about HPV and other STIs. We have allowed our stereotypes about women's sexuality and STIs to put our public health at greater risk.
I find it intriguing that in the case of GSK’s Cervarix, we tend to gloss over that this new vaccine comes with a new lipid-based adjuvant that boosts the immune system.
Cervarix is built upon a relatively new adjuvant, ASO4, which consists of a bacterial endotoxin, called monophosphoryl lipid A (MPL). In doing so, it elicits a robust immune response to the vaccine with the hope that lasting protection is rendered against HPV.
However, pre-clinical studies have shown that antibodies can be generated against MPL which may cross react with other lipids, including sterols, such as cholesterol. Albeit this may not necessarily be bad, but it would be worthwhile to know what autoantibodies are elevated with MPL.
So before giving your daughter a boost with this new generation vaccine, we may want to understand what anti-lipid antibodies are elevated, if any. It is reasonable to believe that GSK and the FDA have already asked whether anti-lipid antibodies are generated in their clinical trial patients. Right? Or at least, we can assume that they are monitoring those that have been vaccinated thus far? Right ? And if so, what are the implications with elevated anti-lipid antibodies in the long run?
I think a physician 50 yrs ago, heck even 30 yrs ago, never would have seen the number of STDs seen today in young women, esp., unless they were prostitutes. I jokingly also asked my gyn this week about how many women he was seeing with shaved labia, and both he and his physician's asst (who was present at my exam) said it was a practice frowned on which took away the protection of the pubic hair and invited infection, and that the ubiquitous thong made for more women patients because of the constant bacterial contamination from anus to vagina. So, for your own health, listen to your gyn, not some popular "stylist."
" Approximately 20 million Americans are currently infected with HPV, and another 6.2 million people become newly infected each year. At least 50% of sexually active men and women acquire genital HPV infection at some point in their lives."
And not only women are at risk from HPV-related cancers:
The American Cancer Society estimates that in 2008, 11,070 women will be diagnosed with cervical cancer in the U.S.
Other HPV-related cancers are much less common than cervical cancer. The American Cancer Society estimates that in 2008, there will be:
* 3,460 women diagnosed with vulvar cancer;
* 2,210 women diagnosed with vaginal and other female genital cancers;
* 1,250 men diagnosed with penile and other male genital cancers; and
* 3,050 women and 2,020 men diagnosed with anal cancer.
So vaccinating men can save a lot of lives, and possibly their own. In addition, many medical groups are now saying that circumcision lowers the risk of contracting and spreading STIs. The chances of getting HIV are drastically reduced by circumcision. I'm sure that will cause a flurry of posts, but it is what the statistics show.
For info on my coauthored book book on Gender and Health: The Effects of Constrained Choices and Social Policies see: http://www.cambridge.org/us/catalogue/catalogue.asp?isbn=9780521682800.
- Thank You
Silly me. Of course it's a sexual morality problem.
http://jama.ama-assn.org/cgi/content/full/302/7/795?home
If you read between the lines, You can see how murky this vaccine really is. My guess is that as the years go by there will be less and less assurance in this vaccine and they are taking all the money they can right now.
We cannot be so gullible as to just believe that any vaccine that comes out will stop the disease that they say it will, as many diseases have many variations that are not covered in the vaccine. We cannot also be so gullible as to say every single vaccine on this earth is bad. Most people do not have the time or inclination to research all vaccines, but if I had a daughter I would *not* give her this vaccine - but you'd better believe that from a young age she would know all about condoms. There are some old generic drugs that work better with less side effects than the new ones, and condoms will always be like that for sex. Not only do they prevent pregnancy, but STD's as well.
There has been countless safety studies done on all vaccines. Vaccines are not associated with austim, learning disorders etc, the studies have been done and published. HPV is a virus that causes cervical cancer in women, so you get this vaccine to reduce your cancer risk. Vaccines improves a child's immune system ablility to fight the specific virus. Your unscienific claims have lead ton of women to believe you and not vaccinate their children against dangerous, fatal diseases. Many of these chikdren have died or have serious complications, including neurological problems.
I will say that the studies are showing that the environmental factors increases risk for austism, cancer and asthma so people should reduce the useage of toxic chemicals in there homes. Plastics, expecially soft plastics such as what is used in baby and water bottles are of MAJOR concern. And we need to clean the water supply. People should feed their children vegatables and proteins and not junk food.
(1) Why haven't there been comparisons between vaccinated and unvaccinated populations comparing rates of autism, learning disorders, asthma, cancer, and diabetes? (Answer: As soon as these studies are done vaccines will be in the trash pile of history.)
(2) Why has children's health gone down as the amount and frequency of vaccines has gone up? Or, to put it another way, are vaccine advocates asking the wrong questions. It is not, Do you want your child to be protected against disease so and so? Rather, the right question is, How can you make your child more resistant against the entire spectrum of diseases? (Answer: Natural food, supplements, and avoiding doctors, their medicines, and especially their vaccines.)
As for your final point... Sure, why make a man go through the horrors of a single shot in order to help slow the spread of a disease that saves its most awful effects for women? Actually, since men are the vectors for this disease, perhaps we should be treated like other disease vectors and rather than be immunized we should be eradicated.
About as absurd as considering that males have any role in birth control.
I think the total cost of the herbs was something like $50.00.
I do think that it makes some public health sense to tilt application of the vaccine first toward those who can gain the most benefit, and there's a good argument that women gain more by preventing cancer than we give up by prioritizing that application. It was wrong for the FDA to use that same reasoning in delaying approval of the vaccine for males. Perhaps we didn't need it as urgently (I don't want to say this is right or wrong, but it seems like what was asserted) but public health is definitely best served by hindering and eventually stopping the spread of HPV.