Is Gardasil Right For You?

@ Suzanne - I didn't realize that I was mentioned in your post.  Thanks for mentioning me!

@ Denise M:  While you are technically correct about distinctions of good v. bad, you do not acknowledge the heart of what Suzanne and Catherine are saying. This creates a fallacy of logic in your argument.

It up to all of us in communications not to be swayed by own biases.

 Too true! These women have presented quite a breadth of quantitative data about this drug, research surrounding it, and a variety of opinions about it. They seem to be going out of their way to make informed arguments and present a less-biased viewpoint. Kudos, Ladies!

 I'm sure lots of good, honest, hard-working Americans work for the FDA, Merck and the ad agency that made those commercials. But that is certainly no guarantee that these organizations and corporations are acting with the interests of the public good at the heart of their operations. If we are not biased, then that is a simple thing to recognize: People in a position to make a lot of money and gain a lot of power have been known to not make decisions for the public good. If we are unbiased in our presentation of information, then we have to admit this readily.

I was suspicious of Gardisil from the start, not because I love to hate wealthy, powerful institutions, but because it was presented as The Best Answer. The PR campaign came hard and fast and didn't seem to be encouraging a lot of reflection.  You get a least a bit of a Whoa, Slow Down with some of these hormonal birth control ads.  Gardisil was too much, too fast, preying on the fears of parents of daughters.  I have little patience for that.

And again, as Catherine has repeated, the numbers don't really add up.

My mind remains open - when I'm convinced, I'll change my mind.

-Atena 

Assumptions, Biases & Irrational Fantasies ( http://antibias.wordpress.com )

As a healthcare and business writer, I understand the skepticism. But this isn't a black and white world. Everyone has a bias, but that doesn't mean there isn't some valid data underneath it. There are greedy bad apples in every group, every company, every industry. That doesn't mean the entire group, company, or industry is a greedy bad apple. And that doesn't necessarily invalidate the data. 
There are also good people throughout healthcare who work hard to make better medicine. Regulatory oversight isn't perfect either, but the people at the FDA work hard to make that oversight as good as it can be for the safety of all. It up to all of us in communications not to be swayed by own biases. Our jobs certainly would be easier if the good guys wore white hats. Absent that, it's up to us to present the information, including the sources, so that individuals can judge for themselves whether the source and data are reliable and meaningful. 

I don't dispute that HPV is pervasive and that cervical cancer can be deadly. However, Gardasil does not protect against all forms of HPV. While it does prevent the most common strains, that might actually enable the other strains to get stronger, just like the overuse of hand sanitizer and antibiotics leads to super germs. In addition, practicing safe sex is an effective way to prevent the spread of HPV. Many men are carriers and do not know it, so it is imperative to practice safe sex all the time, which is good for a variety of reasons anyway.

I'm not saying that no one should get Gardasil, and I completely understand why one would want it. I'm just pointing out that we don't know enough yet about it to compare the risks of the vaccine to the risks of HPV in a fair way. Catherine's right that it is only after long-term studies that we truly get an idea of what the risks of a drug are, and these days, I'm not even sure that drug companies ever release negative info until it is too late.

Suzanne Reisman ( http://blogher.org/member/suzanne ), Contributing Editor - Feminism & Gender ( http://blogher.org/topic/feminism-gender )
Campaign for Unshaved Snatch (CUSS) & Other Rants ( http://cussandotherrants.com/ )

I'm sorry, your statistics are just not convincing me...

With regard to cervical cancer, the CDC estimated a 58% reduction was
achieved in the lifetime risk for cervical cancer for the vaccinated
cohort compared with no vaccination.

This may sound crazy, but I just don't consider a CDC "estimate" of what a "lifetime" risk "might" be, based on a few years of research, all that credible.

This is an interesting article ( http://www.healingdaily.com/conditions/pharmaceuti... )...

Think you
know for sure that the drug you are taking is absolutely safe? Think again.
Many drugs spend years on the market before being taken off the market
because of dangerous side-effects which surface. Aggressive marketing,
slanting research, unethical publishing of results, influencing physicians,
intimidating researchers, pressuring medical centers, manipulating the
FDA, limiting information, marketing drugs with inaccurate safety information
- all of these have created an environment in which drug development has
become a race for the bottom line.

Knowing
how the drug companies operate, it is no surprise when new dangers are
revealed with drugs we've been using for decades and drugs are subsequently
taken off the market.

. . .

Some
of these withdrawn drugs, such as 'Redux', 'Seldane', 'Propulsid',
'Rezulin' , were prescribed MILLIONS OF TIMES. According to Dr. Alastair
J.J. Wood, Assistant Vice Chancellor for Research at the Vanderbilt
University Medical Center (1), a staggering 19.8 million patients
(almost 10% of the United States population) were estimated to have
been exposed to just 5 of the 10 drugs withdrawn in the past 10 years.

. . .

In addition
to the 3 billion dollars they spend on direct marketing to consumers,
drug companies are spending about 15 billion dollars per year on marketing
to doctors.

Most physicians
have no idea that the drug companies are spending on average $10,000 per
doctor to influence their behavior. The doctors do not receive a check,
of course, but the perks are significant.

. . .

The drug
companies claim that they need large earnings - 125,835,595,000 in 1999
(2) - to conduct their research and development. They have a point - only
up to a degree. Aggressive research is indeed needed. The medications
produced by the pharmaceutical industry have improved the quality and
length of life of many people. But this justification loses credibility
when:

1. Just
1 out of every 5 dollars the drug industry collects goes to drug research.

2. Some
drug companies spend almost twice as much money for advertising and marketing
as they spend for research.

3. Drug
industry profits are so large they outstrip every other industry's profits
by far (3).

Also see this from Wikipedia ( http://en.wikipedia.org/wiki/Ethics_in_Pharmaceuti... )...

In 2004 the drug Vioxx ( http://en.wikipedia.org/wiki/Vioxx ), which was a drug produced by Merck & Co ( http://en.wikipedia.org/wiki/Merck_%26_Co ) draws attention and was withdrawn from the market. Merck & Co ( http://en.wikipedia.org/wiki/Merck_%26_Co ) voluntarily withdrew the product due to major concerns about the cardiovascular side effects. The marketing practices of Vioxx ( http://en.wikipedia.org/wiki/Vioxx )
also gained attention with the off-label promotion; there was also a
series of allegations made about the withholding of drug information
and also the use of.

Contributing Editor Catherine Morgan
at catherine-morgan.com ( http://catherine-morgan.com/ ), The Political Voices of Women ( http://politicsanew.com/ ), Care2 Election ( http://www.care2.com/politics/features/ )

HPV vaccination makes sense from a societal level. It's not just cervical cancer at issue.
The CDC in its recommendation for routine HPV vaccination noted the economic burden of HPV: the prevention and treatment of genital warts and cervical HPV-related disease imposes an estimated burden of $4 billion or more (2004 dollars) in direct costs in the United States each year.

Condoms do lower the risk of transmission of HPV, but are not the entire answer. HPV, like herpes, is spread by skin to skin contact. Spermacides do not stop HPV

With regard to cervical cancer, the CDC estimated a 58% reduction was achieved in the lifetime risk for cervical cancer for the vaccinated cohort compared with no vaccination. Another study (with different assumptions) estimated the lifetime risk for cervical cancer among vaccinated females would be reduced by 62% compared with no vaccination.

Outside the United States, the cervical cancer picture is a little more bleak. According to the WHO, cervical cancer is the second most common cancer among women worldwide, and about 80% of these deaths occurred in developing countries.

Excelent post! I've been concerned about Gardasil and it's claims since last year. What sealed it for me was info I found at the American Cancer Society about cervical cancer. From what I read there it seems that Gardasil is more a money maker for big business than an actual preventative measure.

I wrote about it last February here ( http://www.associatedcontent.com/article/141210/is... ).  

Summer

http://wiredfornoise.com

Great information and resources folks!  Get the info and then make up your own mind and allow your daughter to make up hers after giving her the information.    

I recommend the CDC page at: http://www.cdc.gov/STD/HPV/STDFact-HPV.htm 

Nancy

Build Peace ( http://buildpeace.blogspot.com )
Virtuality ( http://www.virtualknowledgegroup.com )
My Life As An Avatar ( http://www.blogher.com/http/secondana.blogspot.com )

( http://buildpeace.blogspot.com )

Does the benefit out weigh the (unknown) risk? According to your comment...

"The bottom line here is that HPV is very pervasive. By the time a
woman is 50, there is an 80 percent chance she will have had HPV. The
vaccine protects against strains responsible for 70 percent of cervical
cancer that cause 3,600 deaths a year. It is a safe and effective
vaccine."

You basically make my point here. If 80% of women are affected with HPV by the age of 50...then the incidence of death from cervical cancer is very low in comparison. See what I am talking about on this list of causes of death by rate ( http://en.wikipedia.org/wiki/Big_killer ) at Wikipedia. Cervical cancer is at the bottom of the list, and even measles (for which we have a vaccine) has a higher death rate than cervical cancer.

The best way to prevent death from cervical cancer is to have regular PAP testing...Most, if not all deaths caused by cervical cancer in our country, is due to not having a PAP test early enough to treat the disease.

This is from The American Cancer Society ( http://www.cancer.org/docroot/CRI/content/CRI_2_4_... )...

About 3,870 women will die from cervical cancer in the United
States during 2008. Cervical cancer was once one of the most common
causes of cancer death for American women. The cervical cancer death
rate declined by 74% between 1955 and 1992. The main reason for this
change is the increased use of the Pap test. This screening procedure
can find changes in the cervix before cancer develops. It can also find
early cervical cancer in its most curable stage. The death rate from
cervical cancer continues to decline by nearly 4% a year.

Since longterm risk of the Gardasil HPV vaccine can not be determined at this time (no matter how you spin the numbers), the benefit can not outweigh the possible risk.

Contributing Editor Catherine Morgan
at catherine-morgan.com ( http://catherine-morgan.com/ ), The Political Voices of Women ( http://politicsanew.com/ ), Care2 Election ( http://www.care2.com/politics/features/ )

No drug or medical procedure is without risk, that's why this discussion is so important. All drugs, even those on the market for some time, have risks, and we need to make educated choices about them. The FDA and the CDC are monitoring the side effects of Gardasil, as well as other vaccines. (FDA requires reports of side effects from all drugs and devices.) Data to date have been reported recently in the major news media. As far as marketing, FDA allows marketing to consumers as long as it is within approved labeling. There are positives and negatives to that, and this  might be another good discussion thread. As for the research into safety: 

From an ABCNEWS story July 14, 2008

Since the U.S. Food and Drug Administration approved the HPV vaccine two years ago, doctors have given more than 16 million doses of the vaccine to approximately eight million girls.

In that same time period, more than 8,000 vaccine-related events have been reported via the Vaccine Adverse Events Reporting System, a safety surveillance program that is coordinated by the FDA and U.S. Centers for Disease Control and Prevention.

Curtis Allen of the CDC says that almost 95 percent of the events are minor reactions, such as sore arms.

Of the events reported, only 7 percent have been classified as "serious." To put this in perspective, Allen says that most vaccines have a 10 to 15 percent serious report rate. The reports have included 10 confirmed cases of a paralytic syndrome called Guillain-Barre Syndrome (GBS), which is associated with certain types of infections. Half of the cases were in girls who also received the meningitis vaccine Menactra, which has been associated with a slightly increased incidence of the syndrome.

According to the CDC's Allen, "The bottom line here is that HPV is very pervasive. By the time a woman is 50, there is an 80 percent chance she will have had HPV. The vaccine protects against strains responsible for 70 percent of cervical cancer that cause 3,600 deaths a year. It is a safe and effective vaccine."

Cervical Cancer causes less than 4,000 deaths each year in The United States. Let's compare that number to others...

Heart disease ( http://healthlink.mcw.edu/article/1031002326.html ) is the leading cause of death for women.

Every year, more than 500,000 American women die from cardiovascular
disease, compared with 40,000 deaths annually from breast cancer.

Cervical Cancer is not even on the list of leading causes of death ( http://www.cdc.gov/cancer/breast/statistics/ ) in women, by the CDC.

From Women's Health USA ( http://mchb.hrsa.gov/whusa_07/healthstatus/indicat... )...

It is estimated that just over 270,000 females will die of cancer in
2007. Lung and bronchus cancer is the leading cause of cancer death
among females, accounting for 26 percent of cancer deaths, followed by
breast cancer, which is responsible for 15 percent of deaths. Colon and
rectal cancer, pancreatic cancer, and ovarian cancer are also
significant causes of cancer deaths among females. Due to the varying
survival rates for different types of cancer, the most common causes of
cancer death are not always the most common types of cancer. For
instance, although lung and bronchus cancers cause the greatest number
of deaths, breast cancer is the most common type of cancer among women.
Other types of cancer that are common among females but are not among
the top 10 causes of cancer deaths include melanoma, thyroid cancer,
and cancer of the kidney and renal pelvis. In addition, other types of
cancer, such as some skin cancers, are common but may not lead to death.

Also see:

Vaccine Safety Group ( http://www.medicalnewstoday.com/articles/63586.php )...

There
have been estimates that fewer than 10 percent, even as low as 1 to 4
percent, of adverse events which occur after prescription drug or vaccine
use are ever reported to government adverse event reporting systems.

"If only 1 to 4 percent of all adverse events associated with GARDASIL
vaccination are being reported to VAERS, there could have been up to 38,000
health problems after GARDASIL vaccination in 2006 which were never
reported," said Fisher. "How many girls are really having short-term health
problems associated with getting this vaccine that could turn into
long-term neurological or immune system disorders? And how many will go on
to develop fertility problems, cancer or damage to their genes, all of
which Merck admits in its product insert that it has not studied at all? We
just don't know enough to be mandating GARDASIL for anyone, much less
vulnerable 11 to 12 year old girls entering puberty."

Millions are being vaccinated in hopes to prevent 70% of 3,600 deaths a year from cervical cancer. Do the numbers really add up????

A total of 7,802 people who received Gardasil, made by Merck and Co.
Inc., have reported adverse events to the CDC's Vaccine Adverse Event
Reporting System (VAERS) between June 8, 2006, and April 30, 2008. The
United States distributed 2.2 million doses of the vaccine in 2006 and
11.3 million in 2007.

Something to think about...

Is your daughter's life more important to Merck than profits from the sale of Gardasil?

The first quart profits for Gardasil were $390 million. Gardasil is predicted to jump to $3 billion in profits by 2012.

Contributing Editor Catherine Morgan
at catherine-morgan.com ( http://catherine-morgan.com/ ), The Political Voices of Women ( http://politicsanew.com/ ), Care2 Election ( http://www.care2.com/politics/features/ )

This is an excellent post Suzanne. I couldn't agree more, especially with...

I think that the word "vital" is the key to this whole saga. Yes,
preventing women from contracting HPV, which can cause cervical cancer,
is a vital part of women's health. However, unlike other
life-threatening illnesses, say polio, there are ways to prevent the
spread of HPV that do not involve vaccinations.

I hate that Merck is allowed to air deceptive commercials suggesting that mothers who care about the life of their child will have them vaccinated for HPV. They are playing on the emotions of mothers, not on the facts, and it makes me sick.

All the current statistics and studies mean nothing to me...It is the long term affects of this vaccine that concern me, and these facts will not be available for a "long" time. Until then, I intend to educate my daughter on safe sex, and the importance of regular PAP tests...In the long-run, this will protect her from much more than the HPV virus.

Contributing Editor Catherine Morgan
at catherine-morgan.com ( http://catherine-morgan.com/ ), The Political Voices of Women ( http://politicsanew.com/ ), Care2 Election ( http://www.care2.com/politics/features/ )

Information about the clinical studies of Gardasil is out. We have to make our assessment of benefit vs. risk. And that will be as individual as we are. 

From prescribing information (which Merck submitted to the FDA and on which the FDA approved Gardasil):
Efficacy was assessed in 4 placebo-controlled, double-blind, randomized Phase II and III clinical studies. Together, these four studies evaluated 20,541 women 16 to 26 years of age at enrollment.
The median duration of follow-up was 4.0, 3.0, 2.4, and 2.0 years respectively. Subjects received vaccine or placebo on the day of enrollment, and 2 and 6 months thereafter. Efficacy was analyzed for each study individually and for all studies combined according to a prospective clinical plan.

adverse reactions:
In 5 clinical trials (4 placebo-controlled), subjects were administered GARDASIL or placebo on the day of enrollment, and approximately 2 and 6 months thereafter. Few subjects (0.1%) discontinued due to adverse experiences.

The vaccine-related adverse experiences that were observed among female recipients  at a frequency of at least 1.0% and also at a greater frequency than that observed among placebo recipients

All-cause systemic adverse experiences for female subjects that were observed at a frequency of
greater than or equal to 1% where the incidence in the vaccine group was greater than or equal to the
incidence in the placebo group

An analysis of injection-site adverse experiences in female subjects by dose is shown in Table 8.
Overall, 94.3% of subjects who received GARDASIL judged their injection-site adverse experience to be mild or moderate in intensity.

A total of 102 subjects out of 21,464 total subjects (9- to 26-year-old girls and women and 9- to 15- year-old boys) who received both GARDASIL and placebo reported a serious adverse experience on Day 1-15 following any vaccination visit during the clinical trials for GARDASIL. The most frequently reported serious adverse experiences for GARDASIL compared to placebo and regardless of causality were:
headache,
gastroenteritis,
appendicitis,
pelvic inflammatory disease

for more info, see http://www.gardasil.com/downloads/gardasil_pi.pdf