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Is HPV vaccine worth it? Researchers weigh in; you may have to decide

August 19, 2009 |  6:00 am

NicolePerhaps you've heard of the relatively new HPV vaccine, Gardasil. If you have a preteen or teenage daughter -- or if you've simply been conscious since the vaccine was approved in 2006 -- we'll assume you have. The vaccine has been marketed, quite heavily, as a way to protect against four strains of the human papilloma virus -- two types blamed for 70% of cervical cancers, and two types blamed for 90% of genital warts.

Almost as soon as doctors and their medical organizations began recommending it, however, push-back from consumers started -- with questions about the vaccine's effectiveness plus complaints about the cost, the number of shots required (three) and, oh right, the negative reactions. Some patients say they became dizzy after getting the vaccine; others reported headaches, fever and fainting. The vaccine was even suspected in some seizures and deaths.

Now, with more than 23 million doses having been administered in the U.S. by the end of last year, researchers with the federal Centers for Disease Control and Prevention, which recommended Gardasil, and the Food and Drug Administration, which approved Gardasil, have taken a look at the data on the adverse reactions to the vaccine. And they've found ... eh, it's safe.

They write: "Most of the AEFI rates [adverse events following immunization] were not greater than the background rates compared with other vaccines, but there was disproportional reporting of syncope [fainting] and venous thromboembolic events [blood clots]."

They conclude that most of the adverse events weren't very serious and that the vaccine has the potential to greatly reduce global HPV-related illnesses and deaths. (The number of deaths from cervical cancer is much higher elsewhere in the world; in the U.S., the pap smear screening reduced such deaths 74% between 1955 and 1992. The American Cancer Society expects just over 4,000 deaths from cervical cancer in the U.S. this year. More of that info here.)

Here's the short version of that new report, published today in the Journal of the American Medical Assn.

A related article, however, takes issue with the marketing of the vaccine and the professionalism of the doctors and medical groups who jumped behind it. Sheila Rothman and David Rothman of Columbia College write:

"By making the vaccine's target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to adolescents was maximized, and the subpopulations most at risk practically ignored. The vaccine manufacturer also provided educational grants to professional medical associations (PMAs) concerned with adolescent and women's health and oncology. The funding encouraged many PMAs to create educational programs and product-specific speakers' bureaus to promote vaccine use. However, much of the material did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on risks and benefits. As important and appropriate as it is for PMAs to advocate for vaccination as a public good, their recommendations must be consistent with appropriate and cost-effective use."

And that's just when they're getting warmed up.

GardasilTaking into account both articles is a related editorial. It states: "Whether a risk is worth taking depends not only on the absolute risk, but on the relationship between the potential risk and the potential benefit. If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened. So rationally she should be willing to accept only a small risk of harmful effects from the vaccine."

Here's the full version of that essay. 

And here's the Gardasil website, in case you're interested. And the "One Less" commercial, courtesy of  YouTube.

Also instructive, as a timeline, is previous L.A. Times coverage of the vaccine and the reaction to it.

December 2008: Low allergic reaction rate seen in Gardasil study

October 2008: Immigrants' advocates decry Gardasil requirement

August 2008: Gardasil's chorus of doubters 
 
May 2007: Benefits of HPV vaccine questioned

March 2007: HPV: Men can get it too

February 2007: Millions of women carry HPV strains that vaccine can block

February 2007: HPV vaccine: Who chooses?

February 2007: Texas requires HPV vaccine

January 2007: Vaccine industry is being revived

June 2006: For women already exposed to HPV, shots may not be as helpful

June 2006: Cervical cancer vaccine approved

-- Tami Dennis

Top photo: A teen gets a shot of the HPV vaccine. Photo credit: Associated Press

Lower photo: Gardasil. Photo credit: AFP/Getty Images



 

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Comments (21)

Yeah, but who PAID for all these "studies" and "research?" Am I supposed to trust something that was funded by Merck itself?

So the FDA approves of something. What does this really mean? They approved heparin too. Am I really supposed to trust people that get paid off by pharmaceutical companies with my health?

Now I may "have" to "decide?"

SRCEW them... not going in my daughter, sorry...

There are many strains of HPV, but the four strains targeted by the vaccine were well chosen: the two most likely to result in cervical cancer and the two most likely to cause genital warts.

I'm wondering why they don't more heavily market this as a vaccine for genital warts. I'm sure that the college population in their late teens and early 20's would be lining up for this if they realized it was 90% effective in preventing genital warts. For this age group, they don't see the risk of cervical cancer but certainly do see the risk of a nasty STD.

DO NOT GIVE YOUR DAUGHTER THIS VACCINATION!!!I waited until my daughter was 14 to get her vaccinated with Gardisal. I wanted to see for several years if it was safe. The doctors at this time told me it was safe. Up until then she never got sick. Two weeks after the first shot, she got really sick and had a bad high fever for over a week. Then her joints started swelling up. After visits to doctors and tests, she was diagnosed with Juvenile Rheumatoid Arthritis, an autoimmune disease. The doctors can't really say for sure that the virus DID NOT cause the JRA. This illness does not run in our family, and last night on channel 7 news they had a report that Gardisal has caused thousands of autoimmune diseases in the young girls who were vacinated with Gardisal, and even deaths. I waited nine years to vacinate her for chicken pox after the vaccination was made, to make sure it was safe. I wish I would have waited longer to vaccinate her with Gardisal. I would not have done it. To have to watch your child in pain, knowing a decision you made for her caused it, is very painful.

What's really wrong with Merck's campaign is that they insisted the shots should be given to young girls -- even though the vaccine's effectiveness may only last for five to seven years! That means a whole lot of women will think they are protected as they become sexually active in their late teens or twenties, when in fact they are not. Also, Gardasil isn't the only HPV vaccine. There's others in development or already available in Europe, so it does sound like Merck marketing rushed women into accepting its vaccine instead of waiting for a vaccine that might require fewer shots or have fewer side effects.

The drug company *HAS* to pay for the studies. Who else would volunteer to pay for them?

It costs over $20 million to do the research and clinical trials. We'd all like to have an independent organization to do the testing, but SOMEONE has to pay for it. Who? The drug company, of course. The FDA can demand lots of tests and data, but they can't do the testing themselves. They have no resources for that.

HPV causes cancers, including the one that Farrah Fawcett died from= anal cancer= and untold misery. All of life is a risk. Look at the statistics. This vaccine is a good thing.

Why would anyone get one of these vaccines. Big pharma and their puppets the FDA are the absolute last ones you want to trust. Watch and read the drug advertisements, and the list of adverse reactions from all drugs should be more than enough to scare people away. It is all about the money. They could care less about your health. Same goes for the scam of swine flu and the vaccine for it. If you truly care for your well-being stay away from all vaccines. The vaccine will kill, maim or sicken you long before the illness from which they are supposed to protect you.

While it is always good to immunize, the way this vaccine has been marketed is a bit deceptive. If one looks back, at the time Merck needed to find a product that could fill the void being left by Vioxx(r). It did not have any pharmaceuticals close to being available but it did have the vaccines Gardasil and Zostavax (for shingles prevention). Both of which were heavily promoted with medical associations, physician offices and public (direct to consumer adds). While it touted the benefits it minimize the potential adverse events and cost. The result - Merck continued profitability to make Wall Street happy and patient felt protected. Unfortunately, we do not know the long term effect (good or bad) of either vaccine. Let's hope this does not create a situation where vaccine makers stop making these valuable products because law suits associated with adverse events from short term gains makes it too costly to produce.

Greg and the rest of vaccine doubters: it is perfectly fine to wait and see if the vaccine is safe and effective. However, to listen to you, we should forgo "polio" vaccines, too. And I think that has been well established to be not only safe and effective, but a true lifesaver. Not all vaccines ought to be ignored or unused.

An ounce of prevention is worth a pound of vaccine. There is only one 100% effective way to prevent HPV, and it has no side effects. I'll give you a hint: it's an 8-letter word that starts with "c" and ends with "y".

I got the vaccine despite being in my late teens and saw no adverse side effects. Vaccines, especially for serious infectious diseases (measles, malaria, etc) are highly successful and typically don't result in serious side effects. The lists of "adverse reactions" are simply there to legally protect the drug companies/manufacturers by admitting, yes, in a few cases bad things happen. It's the same kind of warning as "Caution: The beverage you are about to enjoy is hot" i.e. X could happen, so don't sue us in the rare event it does.

The reason why they tell younger girls to get the vaccine is that HPV is spread through sexual transmission, so the younger the girl the less likely she is to have had unprotected sex. And re: celibacy, isn't it more beneficial to promote safe sex and provide vaccines so that when they get pregnant at least they don't have cervical cancer? Given that unintended pregnancy rates in the U.S. are higher than the world average, "abstinence only" does not seem to be particularly effective.

hat is really wrong with this vaccine is that nobody knows the long term effects of its use. It hasn't been around long enough to tell us what it will do to women 10, 15, or 20 years down the road.

Remember Thalidomide, the wonder drug that was used to treat everything from insomnia to morning sickness. It is the drug that caused horrific birth defects in the children born to mothers that used it. And, if the child managed to escape the birth defects, they would go on to have problems as adults when it came time to have children of their own.

Then there is hormone replacement, for thirty years it was automatically given to women going through menopause. Now they are finding that it, too, has some very serious side effects.

How about Vioxx and Phen Fen ... ?

What all of these have in common is that they were seen as a somewhat miraculous solution. What they all have in common is that they were part of a big direct to consumer marketing campaign (with the exception of HRT). What they all have in common is that time proved them to be not so miraculous after all.

It is not that each of these drugs/vaccines don't have their use or benefits for some. The problem is that we, as consumers, have not been given all the information we need to make informed decisions; and sometimes, to get all the information we need takes time.

Oh, THAT'S long-lasting, Ray.

Yay cancer! I LOVE cancer! Wooo! Down with measures that help prevent cancer! More cancer for EVERYONE! Wooo! Making prevention of transmissible cancers a moral issue and not a medical one means more cancer for you and me! :D

In response to Joe_in_CA where are you getting you information that Merck funded this study? The link to the JAMA article reports the authors as being from the CDC and the FDA. Somehow I think you are making up BS, but feel free to correct me if you have evidence to the contrary.

Furthermore, even IF you were correct who funds a study doesn't mean its' results are automatically wrong. If the methodology is wrong it could be funded by whoever you trust the most and still be wrong. That is why in science we don't automatically assume that the first experimental results are definitive truth. Who funds something doesn't make it right or wrong! What elementary school did you fail that they taught you that scientific truth is determining by whether you trust who funds the lab?

Honestly, while I personally question whether the HPV vaccine is worth the relatively high cost I sure hope parents are making their decisions on not just this, but other issues via better judgment than Joe appears to be using.

In a document on the FDA website dated March 7, 2007 can be found the following statement.

"….most infections (by HPV) are short-lived and not associated with cervical cancer"

This statement is within a pdf file found at this URL.
http://www.fda.gov/ohrms/dockets/dockets/07p0210/07p-0210-ccp0001-01-vol1.pdf

You are looking for the book “The HPV Vaccine Controversy: Sex, Cancer, God and Politics” authored by Shobha S. Krishnan, M.D, Barnard college, Columbia University. It is written without the influence of any pharmaceutical companies or special interest groups. The book educates both professionals and the public about HPV infections, the diseases they cause and the role/ controversies surrounding the new vaccines. The Journal of the American Medical Association (JAMA, June 17th 2009) calls the book superb and a terrific contribution to the field. It is available at amazon.com, Barnes and Noble .com and through international distributors. Link to the book: http://www.greenwood.com/catalog/C35011.aspx

Personally, I will not have either of my daughters immunized for this. First, lets teach our teens the moral and physical dangers of sex outside of marriage. Natural immunization, huh? Second, the long-term effectiveness is unknow, and there are too many side effects coming forward, especially auto-immune, which run in our families to begin with. It's like chickenpox immunization. Let's all get immunized so we can then get it later in life when it's really dangerous.

anyone know about guardasil and trying to concieve? I had only my second shot not going back for my third.. you think i have to wait sometime after my second shot to start tring to concieve???

My daughter is one that was injured by this vaccine. Prior to gardasil, she was running 6 to 10 miles a day, a great student, and generally a happy, healthy girl. That all changed after gardasil, immediately after getting the vaccine. She started having breathing problems three days after, and then chest pains four days after this shot. We spent the next week in and out of the dr's office and the er. Finally, NINE days after the shot, she was admitted to ICU after an er doc discovered that Holly had inflammation and swelling around her heart, a DIRECT result of gardasil, according to the doctor. She spent the next year unable to get off the couch, or go to school, with numerous symptoms and health issues, all because of ONE dose of gardasil. My daughter literally went from running in state level races, and setting school records because of her talent, to not being able to cross the room without help. Gardasil is very dangerous, and needs to be stopped. I am in touch with HUNDREDS of girls who have been injured, and unfortunately am also in touch with a few families that have lost a daughter to this vaccine. It's poison, PLEASE do not vaccinate your daughters.



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