Saturday, April 07, 2007

The HPV Vaccine: A Tough Issue

I had an interesting conversation today with a lady about HPV. It started out when I was sitting in the kitchen, catching up on my blog-reading after a weeklong trip to Hawaii, and listening to WPFW. All of a sudden, out of the blue, the station played this public service announcement, about two minutes long, about how terrible the new human papillomavirus vaccine called Gardasil is, and telling everybody to make sure that Washington DC doesn't pass a new law that would require girls in sixth grade to have the vaccination.

This just totally clashed with the afternoon's "old school" music and took some of the fun out of it, even if it was Sam Cooke singing "Little Red Rooster." (I still like Howlin' Wolf's version of it best.) I had assumed that a vaccination that can prevent most cervical cancer is a good thing. The way the thing was worded, it sounded like you should oppose the vaccine because HPV isn't that bad, it often doesn't have any symptoms at all, and lots of times it goes away on its own. Also, boys should take the vaccine, too, if you're going to make girls take it. Oh, and the vaccine's long-term effects are not known yet.

OK, this is a good one. There are a lot of issues here. I remember a while back in The Post, when Courtland Milloy argued that the idea that DC girls should take the vaccine was based on racist assumptions. I started to blog about his column, and decided against it, mainly because it was a little bit off-topic for this site. I especially have no desire to make racial issues a dominant theme here; there's a time and place for that important topic, but we are somewhat limited in our scope on this site.

Anyway, I called the number in the ad, just to see who and what was behind all this. After some maneuvering, I ended up talking with a live human. I didn't write down the lady's exact wording or anything, but I got the gist of it pretty clearly.

Let me try to list off the issues that were mentioned, between the ad and the conversation:
  • The vaccine was not properly tested
  • The vaccine only attacks four kinds of HPV, and not others (there are more than 50 types)
  • It will only prevent seventy percent of cervical cancer cases
  • Only eight women died (time frame unclear -- last year? ever?) of cervical cancer in DC
  • Follow the Merck money (it is suggested that some politicians may benefit from this policy)
  • It is not clear who's liable if the vaccine has negative effects
  • The government shouldn't tell people what medicine to take
  • You have to have sex to get it

Unfortunately, all these arguments get tangled up together, and the result is an incohesive kind of ranting that is probably not going to convince anybody.

The group that placed the ads is called The Parents and Friends Committee to Stop Medical Experimentation in Washington DC. You can check out their web site HERE, if you'd like. I guess they want to make it sound like the city just wants to use DC children to experiment on. Uh, I think that might be overplaying their hand.

Was the vaccine properly tested? You might remember that the clinical trials were actually stopped in the middle, when it was discovered that this stuff worked so well that the researchers wanted to make sure the placebo subjects were able to get it, too. Since this is a new product, of course nobody does actually know if there will be effects in ten or twenty years. Probably not, since the way it works is pretty well understood. I think the "longterm effects" argument is probably not too strong, and that the stuff is almost surely safe enough to use. From what I can tell, the tests were thorough. They tested it on 20,000 women, and found it very effective. Most of the observed side effects were pain at the injection site, fainting or dizziness when the shot was given, and some recipients got a fever. There were three cases of Guillain-Barre syndrome, which has been observed with other vaccines as well. Nothing outrageous, nothing unusual, there aren't a bunch of warning labels on the stuff.

True, the vaccine only attacks four kinds of virus: types 16, 18, 6, and 11. The first two of these cause about seventy percent of cervical cancer cases in the world, and the last two cause about ninety percent of genital wart cases. So, in my book, that's worth doing. Well, I don't know if it's worth making it mandatory, but it does sound like a reasonable personal decision to take the vaccine.

It has been estimated that 9,700 women would develop cervical cancer in the United States in 2006, and 3,700 would die, which seems like a lot to me. According to Milloy's article, in the US cervical cancer strikes 8.8 per 100,000 females, with a rate of 13.5 per 100,000 in the District. OK, so DC is well above the average, that's a point in favor of requiring the vaccine.

The anti-vaccine group lady told me about a Dr. Harper who opposes Gardasil. Dr. Diane M. Harper, physician, professor and the director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School in New Hampshire, is pretty easy to find on the Internet, she seems to be an outspoken opponent of the implementation of Gardasil. She makes a strong case, but I have to say I was a little discouraged to discover (HERE) that she was on the research team working on the "other" anti-HPV vaccine. Gardasil is produced by Merck, and the other drug, Cervarix, is being developed -- and is not yet approved -- by GlaxoSmithKline. In earlier news stories, even a year ago, Dr. Harper was quite optimistic about the vaccines -- see THIS ONE, for example. But nowadays she's talking like it's unethical to give it to girls to prevent HPV. She, like the Parents, uh, Against Experimentation, seems to have one reason after the other why this is a bad idea.

In case you can't tell, my personal opinion after studying some of this on the Internet is that Dr. Harper has some personal interest in the outcome of this debate. Maybe I'm wrong, but I am not comfortable with her apparent one-eighty on the issue.

I don't know where the lady I talked to got the information that only eight women in Washington, DC, had died of cervical cancer, but ... why would that matter? About 20 million people in the US are infected with HPV, 9,700 new cases of cervical cancer diagnosed each year. I have a hard time seeing the downside of reducing those numbers.

The Merck money, that's a tough one. The pharmaceutical industry, known as Big Pharma, is a diabolical beast. Yes, they give us health treatments undreamed-of in the past. But they want their money. Like, the governor of Texas, Republican Rick Perry (who is known for his perfect hair), recently signed an executive order saying that 11 and 12 year old girls must have the new vaccine. An executive order is not a law, but a lot of people think it is. Well, it turns out Merck donated a lot of dough to his campaign, and ... here's how Medical News Today put it:
The Associated Press on Wednesday reported that, according to documents, Perry's Chief of Staff Deidre Delisi and aides discussed Gardasil on Oct. 16, 2006, the same day that Merck's political action committee donated $5,000 to Perry's campaign and $5,000 total to eight Texas lawmakers. The documents also show that Perry aides met with Merck lobbyists beginning in mid-August 2006. Robert Black, a Perry spokesperson, on Wednesday said the timing of the meeting and donations were coincidental, adding that during the October 2006 meeting there was "no discussion of any kind" about mandating Gardasil.

Mmm, coincidental, uh huh.

The new drug costs about three hundred dollar per patient, doled out over three doses. Why is it so expensive? Most people who are watching the situation say it's expensive because Merck lost a $254 million lawsuit last year over Vioxx, after, y'know, a bunch of people had died. So this is tough -- the fact is, you can't trust these guys. The FDA is just as bad, the Bush administration just wants to make sure the corporations make money, and you really can't depend on the FDA to actually regulate anybody. So the public is on its own, we have to balance out whatever facts we can scrape together, to make a reasonable decision. Follow the money: well, as usual, the money stinks. Washington DC politicians may have their own reasons for wanting to boost Gardasil sales in the District; I can't see that that makes it a bad idea, it's just the way it is these days in America.

Liability is a mess, too. Say the vaccine does have a bad effect. Who pays? That question should be answered clearly before any law is passed.

To my mind, the one real issue here has to do with deciding when the government has the responsibility to tell people what medicine they need to take. Some of us old farts remember polio, and all those people you'd see in wheelchairs and on crutches, but kids today don't know what it is. Nor do they know smallpox, tuberculosis, mumps, lots of things. And that's because of mandatory vaccinations. So I think most of us agree it's okay sometimes for the government to tell people to take the medicine.

But the other side of it is the Terry Schiavo situation, where Congress literally passed a bill telling this guy what treatment to get for his wife. It was nobody's business, and no sensible person believes that the government should be making people's personal decisions for them to that degree. Okay, Republicans like it that way, but most of the rest of us agnostics would like the government to stay out of our personal business most of the time. So it's a balancing act. This is where the people need to discuss the issues calmly, carefully, and decide. Should the vaccination be required for girls? What about for boys? The role of government, I think, is the real question, and should be answered carefully. But I see no reason that an answer can't be produced eventually, and people will live with it, either way.

Finally, the lady I talked to said something weird. She said you don't get HPV from somebody breathing on you, you have to have sex to get it. I asked her why that made any difference. She thought it made all the difference. I pointed out that eighty five percent of Americans have had the virus, and she wanted to say Yes, and look what happened to them -- nothing, but I wouldn't let her change the subject.

She claimed not to agree with the religious right. She was well aware of the debate over abstinence, and said -- and I believed her -- that she didn't think it was realistic to expect abstinence. But at the same time, there was a sense that HPV is something you get when you're doing something you shouldn't. The fact that it's sexually transmitted made all the difference. Does it?


Blogger Dana Beyer, M.D. said...

This is a remarkable situation. This is the first vaccine directed, primarily, at preventing cancer. While not that many American women die of cervical cancer, the number of minority women is way too high. Globally, cervical cancer is the number two cancer killer of women, so this vaccine has huge public health potential.

There is no reason to believe the vaccine will not be effective long-term, since we have hundreds of years of experience with vaccines directed against viral pathogens. Boys are currently being tested, and the vaccine should be prescribed for them in the near future. For those squeamish CRC folks out there - you know who you are, Dr. Jacobs – this will prevent anal cancer as well.

This is not about STDs, except in the most general sense. All you need for transmission is some light petting below the belt (I apologize for that archaic locution) to transmit this bug, and to the best of my knowledge, James Dobson hasn’t called for criminalizing such sexual behavior – yet. Phill Kline, the state Attorney General in Kansas did, and he lost his election as a result.

One of the government’s primary obligations is to protect public health. This is a public health concern, because it is not about any given individual, but is directed at eradicating a pathogen from the general population. Once you raise the vaccination rate beyond a certain threshold, say 92% in the case of measles, the entire population is protected. That, in my book, is a good thing.

The politics is much murkier, and this is a good example that should be used to support public financing of campaigns. The success of this vaccine has been so explosive that there has not been the usual time for public education. Merck, in supporting its legislative efforts, particularly with women’s groups, moved very quickly, but in so doing undercut its argument with the appearance of a serious conflict of interest. Senator Kelly in Maryland withdrew her bill because she had accepted significant campaign contributions from Merck. I should point out that this vaccine was in the pipeline long before there were any evident problems with the COX-2 inhibitors such as Vioxx. I would also like to point out that I support the mandatory use of this vaccine in spite of the fact that Merck didn’t even offer me a campaign contribution last year.

April 08, 2007 3:14 PM  
Anonymous Anonymous said...

Good job!

October 28, 2007 3:10 PM  

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