I am sure many of you have seen the commercial for Gardasil, Merck's HPV vaccine that was approved by the FDA in 2006 to prevent cervical cancer in women ages 9-26. Gardasil protects against 4 types of HPV, including 2 types (16 and 18) that cause 70% of cervical cancer cases and 2 more types (6 and 11) that cause 90% of genital warts cases. I know several young women who have gotten this vaccine in an effort to further protect themselves from sexually transmitted diseases. Just last week, Bloomberg news reported that the FDA cleared the vaccine for use in males as well.Call it fear, call it whatever you want. I'm just not comfortable with it. This vaccine was approved in six months by the FDA, and its efficacy rate has only been measured up to five years. Although I don't doubt Merck's reliability, (given the englightening Vioxx debacle) I can't quite get on board with a vaccine that does not detect much more than an annual pap smear. Also, as time goes on, Merck continues to expand the side effects and had to recently change the labeling to include fainting and seizures.
That being said, I am all for individual choices. I fully support having the option to get the vaccine if I so desire, and I respect those who believe this vaccine is the best way to fight cervical cancer. However, once the government decided to make Gardasil mandatory for immigrants, it went too far. How can the CDC liken an HPV vaccine to one for the measles or chicken pox where children can actually spread the disease just by common interaction? And if the vaccine isn't mandatory for US citizens, what kind of judgment is the American government making about immigrant women? Welcome to the United States where we will deny you entry if you don't get a vaccine that we cannot guarantee is safe for our own people. Let freedom ring.
Robin, how long is it supposed to take for the FDA to approve a vaccine/drug, etc.? I mean there are scores dying from the swine flu, but for some beaurecratic reason, we can't approve THAT vaccination.
ReplyDeleteWe have decided as a nation that immigration is not a right, it's a privilege, and we consistently have different standards for
ReplyDeleteimmigrants than we do for our own citizens. Immigrants who are educated have a much better chance of getting into the US, if you have
over $1MM assets, you are virtually guaranteed entry. Do you believe we shouldn't have higher health, income and education standards for immigrants?
The counter argument is the libertarian argument for open borders, do you espouse that view?
A very high proportion of adults carry some form of HPV, it's estimated to be the most common STD. Some forms of HPV cause cervical cancer. Is it so onerous to try stem this tide via enforcing reasonable health standards on immigrants?
I appreciate the comments!
ReplyDeleteHere is a helpful link about the CDC's extremely extensive process for approving a vaccine:
http://www.hhs.gov/nvpo/factsheets/fs_tableII_doc2.htm
While the time differs for different vaccines, Gardasil was evaluated and approved under the FDA's priority review. While its rapid approval rate has been seen by some as a sign of the FDA's commitment to fighting cervical cancer, I worry that part of it was the intense pressure the FDA felt to approve the first vaccine preventing HPV.
Vimspot,
ReplyDeleteThank you for your insight! I completely understand that immigrants have different standards. For instance, immigrants must pass a citizenship test that most citizens would probably fail. However, I feel comfortable drawing a distinction between education and the administration of a vaccine not even mandated by the United States. My concerns are twofold:
First, the vaccine is mandatory for immigrant women, not men. At the end of the day, I do believe all women should be able to weigh both the benefits and risks of being injected with Gardasil. Dr. Jon Abramson, CDC Chairman of Immunization Practices, even recommended that the vaccine should not be mandatory for immigrant women because HPV is not a communicable disease like chicken pox. According to the Wall Street Journal, of the 14 required vaccines, 13 are designed to combat infectious diseases that are transmitted by respiratory route and are considered highly contagious. Gardasil is the sole exception. See http://online.wsj.com/article/SB122282354408892791.html
Are we really "stemming the tide," or are we unfairly abusing our power by imposing an unnecessary health standard?
Second, as far as I know, there is not yet an opt out provision for immigrant families that cannot afford the exorbitant costs of all three shots. Without health insurance, Gardasil can cost up to $162 per shot, and making it mandatory can serve as a serious financial barrier to female immigrants.
Again, I want to reiterate that I haven't quite come to terms with my own thoughts about whether or not to take the vaccine, but I continue to appreciate that the choice is mine to make.
Robin, do you think the pressure to quickly approve the vaccine had to do with Merck pushing hard on approval, or more to do with the FDA wanting to show the country that it can get things done? Regardless, given the absurd consequence on immigrant women, it obviously wasn't fully thought through.
ReplyDeleteI honestly think it's both. The FDA is under tremendous industry pressure to improve drugs more quickly, along with societal pressure to function as an effective regulator. It's a tough job.
ReplyDeleteAlthough unrelated, if you have a chance to read David Kessler's A Question of Intent, it gives a phenomenal history of the FDA's attempt to fight tobacco and really highlights the thought process of the agency.
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