Re: Drugmakers & Politicians forcing STD shot: followup

From
http://evilslutopia.blogspot.com/2007/01/gardasil.html


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January 3, 2007
10 Things You Might Not Know About Gardasil

You might have noticed recently that the makers of the new HPV vaccine Gardasil really really really want you to try their product. I think the TV commercials are running about every 7.5 seconds. I admit that I tend to be pretty skeptical of the whole women’s health “industry”, so after seeing the ads about five million times, I decided to do some research.


10 Things You Might Not Know About Gardasil


1. The vaccine only decreases your chances of getting cervical cancer, it doesn’t eliminate the risk.


Straight from gardasil.com:

“HPV Types 16 and 18 cause 70% of cervical cancer cases.

GARDASIL may not fully protect everyone and does not prevent all types of cervical cancer, so it is important to continue regular cervical cancer screenings.”[1]

Merck is upfront with this information; they don't try to hide it or spin it. But with all of the media coverage and information floating around about the "100% effective cancer vaccine", it's helpful to remember that Gardasil is only 100% effective at doing what it is supposed to do, which is preventing certain specific types of HPV, not preventing all cervical cancer.


2. Even without the vaccine, the number of cervical cancer cases is trending downward and has been for years. (This is only true in the U.S.; worldwide it is one of the top cancer killers of women because women in many other countries have limited access to Pap tests and other health services.)

The Gardasil commercials refer to "thousands of women" being diagnosed with cervical cancer in the U.S. each year, which is true, but they don't put that number into context.

“Cervical cancer has gone from being one of the top killers of American women to not even being on the top 10 list. This year cervical cancer will represent just 1 percent of the 679,510 new cancer cases and 1 percent of the 273,560 anticipated cancer deaths among American women. By contrast, some 40,970 women will die of Breast Cancer and 72,130 will die of lung cancer.

According to the American Cancer Society, "'Between 1955 and 1992, the number of cervical cancer deaths in the United States dropped by 74 percent.' Think about it: 74 percent.”[2]


So Merck wants parents to have their pre-teen and teenage daughters vaccinated. But if current trends continue, by the time these girls are old enough to be at risk, how big will the risk really be? Check out the government's statistics on cervical cancer for yourself at the National Cancer Institute website.



3. Gardasil is one of the most expensive vaccines ever, at about $360 for the series of three shots, plus the cost of doctor visits. Call me cynical, but I can’t help but think about how much money Merck stands to make from this if they can manage to convince all young women and all parents of young girls that this vaccine is a necessity. And while we’re at it, call me a Conspiracy theorist too for wondering if maybe Merck just might be exaggerating the cervical cancer risk by a lot in order to scare young women and mothers into buying their product.

"'We're seeing a fairly remarkable uptake of Gardasil,' said Rick Haupt of Merck & Co., which reported sales of the vaccine had reached $70 million, exceeding analysts' projections.”[3]

Gardasil is a cash cow. The revenue stream is big now, with the potential to get much bigger. This is especially important for Merck, which is still dealing with the scandal surrounding their pain medication Vioxx, which they had to withdraw from the market in 2004 after it was found to increase the long-term risk of heart attack and stroke in patients who took it regularly. Thousands of lawsuits have been filed by former Vioxx patients. Vaccines like Gardasil are needed to provide the constant stream of cash that will help Merck to recover from Vioxx.

“Merck, struggling since the 2004 recall of its blockbuster pain pill Vioxx, has staked its turnaround in part on vaccines. They accounted for $1.1 billion of its $22 billion in revenue last year, or 5 percent, the highest share since at least 1995." [4]

4. While we're on the subject of liability, lawsuits, and profits, there's another angle to consider. If Merck can get state governments to put Gardasil on their lists of vaccines that are required for schoolchildren, it can become a part of a federal vaccine liability program. Meaning that Merck will not be liable if Gardasil turns out to be harmful some time in the future. [5] [6] [7]

If I felt like being cynical again, I might think that this is one of the reasons why a vaccine for a sexually transmitted disease is being marketed not just to young women who are having sex or are going to become sexually active soon, but also to girls as young as nine. There’s a hell of a lot more stability and profitability in a required childhood vaccine than there would be in an optional vaccine meant only for young women.

It's important to remember that no matter how many feel-good, we're all in this fight together and we're just doing this out of the goodness of our hearts ad campaigns they run, drug companies are not non-profit organizations. They are in this to make money and a lot of it, and while that doesn't mean that all prescription drugs are harmful and horrible or that all doctors are evil, it does mean that when it comes to our health, we probably shouldn't take anything at face value.


5. There have been no long-term studies done on the effect of the vaccine after 5-10 or more years, and testing on young girls has been extremely limited.


“Merck has tested the cervical cancer vaccine in clinical trials of more than 20,000 women (about half of them got the shot). The health of the subjects was followed for about three and a half years on average. But fewer than 1,200 girls under 16 got the shots, among them only about 100 9-year-olds, Merck officials said, and the younger girls have been followed for only 18 months." [8]

If parents are expected to take their daughters to get a series of expensive immunizations, wouldn’t it be nice if they had any idea at all about what effects these girls might have to deal with 5 or 10 years down the line?

If you're wondering what the rush was, part of the answer could be patents. When a company's patent on a particular drug expires, that's when generic versions of the drug can be developed and released into the market, which obviously drives the price and the profits of the original drug way down. Merck's patent on the extremely profitable cholesterol drug Zocor expired in June of this year, and Gardasil is one of the new drugs being counted on to bridge Merck's financial gap. According to the FDA, Merck filed an application for a patent extension for Gardasil on December 6th.

This CNN Money article has more info on Merck's financial past, present, and future.



6. It is unknown how long the immunity provided by Gardasil actually lasts.

“Public health officials want to vaccinate girls early, before they become sexually active, even though it is not known how long the immunity will last.” [9]

“Tests show that the vaccine lasts at least four years. Long-term results aren't known yet.” [10]


And straight from the FDA:

“The duration of immunity following a complete schedule of immunization with GARDASIL has not been established.”[11]


So if I do decide that it’s worth the risks to my hypothetical nine year old and that I should go ahead and give her the vaccine, in the end I don’t even know if it will do her any good at all by the time she actually becomes sexually active.

I completely disagree with the people who are against this vaccine for “moral reasons” and claim that the vaccine will encourage young women to be promiscuous because their STD risk will be reduced. But I do have a problem with the fact Merck isn’t telling women that their immunity may only last for a few years. The women and girls who get the vaccine may base some of their future sexual choices on the assumption that they are protected, but by the time many of them become sexually active this may not be true anymore.



7. The studies done on Gardasil were not set up to investigate whether the vaccine itself has the potential to cause cancer.

“GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity.”[12]

car·cin·o·gen
n. Any substance or agent that tends to produce a cancer.


ge·no·tox·in
n. A chemical or other agent that damages cellular DNA, resulting in mutations or cancer.



8. Gardasil is one of many vaccines containing aluminum, and there is increasing evidence suggesting that aluminum-based vaccines can have harmful effects. Aluminum is a neurotoxin and the aluminum in vaccines can potentially reach the brain. Since the list of required childhood vaccines is only getting longer over time, children are being exposed to doses of aluminum that may exceed what their bodies are capable of managing. Aluminum in vaccines has been linked to a variety of neurological disorders, including Alzheimer’s, although a lot more research is needed. [13] [14]

It's also interesting to note that according to the FDA, Merck tested Gardasil along with the Hepatitis B vaccine (currently on the required list), to make sure that there were no negative effects to administering both vaccines during the same doctor's visit. The tests showed no apparent problems. [15] However, the hepatitis vaccine was the only one that was tested, so it is unknown whether any of the other required childhood vaccines could be potentially harmful when combined with Gardasil. There was also no information in any of the studies about what adding Gardasil to the required list would do to the cumulative aluminum levels in children's bodies.


9. Gardasil is only for women.


"Boys would not have to be vaccinated, although they can get HPV. There are no HPV tests for men. The vaccine has not yet been tried on men." [16]

Men can get HPV. Men can give HPV to their partners. Men can get genital warts from HPV. Men can get cancer from HPV. (80% of HPV-related cancers affect women, but the other 20% include penile and anal cancers affecting men). [17]

So why wasn’t Gardasil tested on men, and why isn’t Merck funding PR campaigns to educate men about their HPV risk? Is it because they feel that there’s more of a stigma surrounding men’s sexual health, and that it would be more difficult to convince men and parents of boys of the risks? And as a result they wouldn’t be able to make nearly as much money off of men as they will off of women. (Sorry, there’s that cynical thing again.)

I think both men and women can take issue with this. Men, because their sexual health is really not being addressed here. They don't even have a test that can tell them whether they have HPV or not, so even if they want to be responsible about it there is only so much they can do. And women, because they are being asked to take full responsibility for HPV prevention. Women and girls are expected to take on all of the costs and the risks of this vaccine, and even if they do get vaccinated they could still be infected with HPV by a male partner who has been told that HPV isn't something that he needs to worry about.

From the Centers for Disease Control and Prevention website:


"There is no clear health benefit to knowing you have this virus—since HPV is unlikely to affect your health and cannot be treated. For most men, there would be no need to treat HPV, even if treatment were available— since it usually goes away on its own." [18]

Isn't it a little irresponsible (and sexist) to say there is no benefit to a male HPV test? Regardless of the possible health issues such as penile or anal cancer, isn't not infecting your unsuspecting partner also considered a benefit? Men are reassured that tests and treatment are unnecessary because their HPV infections will likely go away on their own, while the fact is that most women's HPV infections will go away on their own as well. [19]

Apparently, when Gardasil went before an FDA panel for approval, Merck asked the panel to approve the vaccine for boys also, even though they have not done the same amount of testing on boys as they have on girls.


"Merck asked the committee to endorse vaccination of boys age 9 to 15, too. Urging them not to wait for ongoing studies to end, it said evidence shows Gardasil can prevent some male cancers and may slow the spread of sexually transmitted HPV.
'By delaying three-plus years, we could have an additional 100,000 [cancer] cases that could have otherwise been avoided,' Barr told the committee. But panel members didn't vote on the request, calling the idea compelling but unproven."[20]


It seems to me that we need to spend more time researching HPV in men and boys, not less time. And it would be nice to feel like Merck was taking this issue seriously and not just tacking it on as a "me too" measure in order to get approval more quickly. On the flip side, it's a positive step that more research on HPV in men is now being done. Maybe they'll even change their minds and decide that it is worthwhile to develop a male HPV test after all. They could probably share a lab with the researchers who are hard at work on that male birth control pill we've been hearing about for years.


10. The bottom line: Don't get this vaccine just because your doctor/mom/sister/friend/a perky TV commercial told you to. But don’t not get it just because some chicks with a blog say that they aren’t going to. It’s your health, your decision. Do your own research and accept no guilt trips. My own mom wanted me to consider getting the vaccine (it is also being recommended for sexually active young women, even though it will probably do us—well, do evil slutty me anyway—no good), but she encouraged me to research it first, so I did. When I told her what I had found out, she agreed with my decision not to get it.

The Gardasil ad campaign is screaming at us to be “One Less”, meaning one less woman affected by cervical cancer. I’m all for that. I’m just going to try to reach that goal in my own way…as one less woman making an uninformed decision. Tweet