Sep 152011

In his critique of the recent CNN/Tea Party sponsored Republican presidential candidates debate, The Daily Show’s Jon Stewart described the set as looking like the inside of Betsy Ross’s vagina.  Crude but apt for a debate that saw two candidates stumble badly on the unlikely political football that the HPV vaccine has become.

As has been well reported, Texas Governor Rick Perry has been trying to distance himself from his highly publicized effort to mandate the vaccination of all girls in Texas because in addition to sounding like the dreaded idea of  government interference in our lives which strikes maniacal fear in the hearts of Tea Partiers, it has served to highlight the large donations Perry has received from Merck, the maker of the HPV vaccine Gardisil.  Michele Bachmann, not wanting to be left out, then claimed that she had heard from a mother whose daughter became mentally retarded because of the vaccine, a claim that is questionable and certainly not proven.  All of which has served to kick up some major dust in the absurd debate about whether it is un-American big government at its worst to mandate vaccinations as opposed to being un-American to not vaccinate children because it imperils public health.

Unfortunately, both stances not only lack subtlety, they  completely miss the real issues involved that need to be addressed in regard to the HPV vaccine.  In 2007, after Perry’s short-lived effort to mandate HPV vaccination, I pointed to some of the problematic issues in the debate about Gardisil:

Cervical cancer is only expected to cause 3,670 deaths in the U.S. in 2007, a miniscule percentage (less than 2%) of the 270,000 deaths from the disease worldwide and only 1% of the total annual number of deaths from all cancers in the United States.

While cervical cancer used to be one of the deadliest diseases for women in the U.S., the number of deaths it causes has dropped dramatically (by 74% from 1955-1992) and it continues to drop). Why then are so many states considering mandating a vaccine that costs $300-$500 per patient for a type of cancer that is already largely under control in this country and which can be almost entirely prevented by regular gynecological checkups and Pap smears?

Merck & Co., the giant pharmaceutical company that makes the vaccine Gardasil, (spent) millions of dollars lobbying state legislators. In Texas… Gov. Perry received $6,000 from Merck’s political action committee during his last campaign. One of Merck’s key lobbyists in Texas is Perry’s former chief-of-staff, the mother-in-law of his current chief-of-staff, and the state director of Women in Government, a national advocacy group of female state legislators that has received substantial funds from Merck.

It is important to note that low-income women and women who do not have health insurance are most at risk because they are less likely to get regular Pap smears. More than half of the diagnosed cases of cervical cancer are in women who have not had a Pap smear in three years. While Gov. Perry has mandated that the state of Texas foot the bill for those who can’t afford the expensive HPV vaccine, it is unclear where those funds would come from either in Texas or in other states that are considering making the vaccine mandatory. And obviously the cost of the vaccine makes it prohibitive in the countries where it is most needed and would potentially do the most good.

What is clear is that Merck has a substantial financial interest in the vaccine becoming mandatory even though the added benefit to public health is both minimal and costly. With more than 10 million girls in the U.S. between the ages of 10-14, the drug company stands to make billions of dollars preventing a disease that is already treatable in the targeted population. Since the vaccine does not eliminate the need for regular Pap smears, it would appear that a far more appropriate and cost effective first step would be to make regular gynecological healthcare available for all women regardless of income and medical insurance, particularly since this step by itself would go a long way in reducing the few cases of cervical cancer that still occur in this country.

There is however another significant public health concern in regards to the HPV vaccine, namely that it is a very new drug with no history. We are of course being told that it is perfectly safe and has few side effects, but we were also told that about Thalidomide, DES, and Hormone Replacement Therapy. Negative health concerns have also been raised about other children’s vaccines and the Anthrax vaccine given to those in the armed forces as well as drugs such as Vioxx, another Merck drug.

While Merck says that Gardasil is 100% effective in preventing the two types of the HPV virus that cause 70% of all cervical cancer, questions have arisen about these results. In an article in Healthfacts, Maryann Napoli, associate director of the Center for Medical Consumers reports that according to Barbara Loe Fisher, president of the National Vaccine Information Center and a former member of the FDA Vaccines and Related Biologic Products Advisory Committee, the placebos in Merck’s studies contained aluminum (which is reported to cause inflammation and cell death in animals and humans) rather than saline solution, which according to Fisher “violates the principle of scientific method…making it hard to tell whether the many adverse events reported were due to the use of aluminum in both the placebo and the drug or to the Gardasil itself.

And in an essay published in The New York Times in July 2006, Roni Rabin points out that most of the subjects in the Merck trials were women over the age of 16. Rabin found that the vaccine was only tested on 1,200 girls under the age of 16. In addition, the vaccine is so new that it is not yet known for how long it will be effective or whether a booster will be required. It is also important to note that Merck’s own literature states that Gardasil, “has not been evaluated for the potential to cause carcinogenicity or genotoxicity.”

I also discussed Merck’s marketing campaign and the fast tracking of the FDA approval of Gardisil here,

The New York Times ran several articles by Elizabeth Rosenthal (here and here) that finally address the points that I had raised. Rosenthal writes that, according to the New England Journal of Medicine,

“Two vaccines against cervical cancer are being widely used without sufficient evidence about whether they are worth their high cost or even whether they will effectively stop women from getting the disease.”

Those are rather serious issues considering that 16 million doses of the drug have already been distributed in this country alone, at a cost of $360 and upwards for a series of 3 shots, putting a serious crimp on the pocketbooks of parents and public health agencies and billions of dollars into the Merck coffers. And as Rosenthal points out, while cervical cancer is a major killer in developing countries,

“In developed countries, Pap smear screening and treatment have effectively reduced cervical cancer death rates to very low levels already. There are 3,600 deaths annually from cervical cancer in the United States, 1,000 in France and 400 in Britain.

Given that there are still serious unknowns about the effectiveness and safety of the vaccine, it is important to examine the sudden concern about HPV and cervical cancer.

“”Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now,” said Dr. Diane Harper, a professor of medicine at Dartmouth Medical School. Dr. Harper was a principal investigator on the clinical trials of both Gardasil and Cervarix, and she spent 2006-7 on sabbatical at the World Health Organization developing plans for cervical cancer vaccine programs around the world.

“Because Merck was so aggressive, it went too fast,” Dr. Harper said. “I would have liked to see it go much slower.”

In receiving expedited consideration from the Food and Drug Administration, Gardasil took six months from application to approval and was recommended by the C.D.C. weeks later for universal use among girls. Most vaccines take three years to get that sort of endorsement, Dr. Harper said, and then 5 to 10 more for universal acceptance.”

And as anyone who watches television, reads teen and women’s magazines or has been in a pediatrician or gynecologists office lately knows, the Merck marketing campaign was indeed quite impressive. The campaign has included such tactics as getting hundreds of doctors as unofficial spokesmen (paying them $4500 for each talk given about Gardisil), letting girls sign up to get text messages reminding them to get their next dose of the vaccine (as long as they let Merck use the information they provide for marketing purposes) and funding ‘awareness’ conferences, sometimes not so transparently.  Merck also has provided substantive funding to legislative groups such as “Women In Government”, a group that suddenly appeared from nowhere to champion the vaccine (see this earlier post detailing the funding trail for this seemingly impartial group.)
There are also serious questions about the use of health dollars on this very expensive vaccine,

“(W)ith their high price, the vaccines are straining national and state health budgets as well as family pocketbooks. These were the first vaccines approved for universal use in any age group that clearly cost the health system money rather than saved it, in contrast to less expensive shots, against measles and tetanus, for example, that pay for themselves by preventing costly diseases.”

“Looked at another way, countries that pay for the vaccines will have less money available for other health needs. “This kind of money could be better used to solve so many other problems in women’s health,” said Dr. (Abby) Lippman at McGill (University). “Some of our provinces are running out of money to provide primary care. I’m not against vaccines, but in Canada and the U.S., women are not dying in the streets of cervical cancer.””

Another concern is that since it is not yet known for how many years the vaccine provides protection, the vaccine could actually cause more deaths by, “giving girls false security that they are protected for life and no longer need to be screened.”

To be very clear, it is should be obvious that we should be completely in favor of a vaccine that effectively saves lives. The uncomfortable truth however  is that our health care decisions are all too often predicated by the corporate  bottom line rather than the public good.  When a large pharmaceutical company launches a huge advertising campaign and sprinkles huge campaign contributions around to secure the fast-track approval and use of a very expensive vaccine with known efficacy and safety issues (for an informed discussion of this, please see Marcia G. Yerman’s series on the HPV vaccine that begins here), we need to raise a caution flag. The key issue that we need to keep sight of  is how large corporations are framing (and funding) our political debate and the harm that does to our health and well-being.


Addenda:  For more on Perry’s links to Merck, see this.

And while I don’t totally agree with her viewpoint on vaccines, Amanda Marcotte points to the issue of sexual control which is most definitely part of the rightwing argument against the HPV vaccine.  While I have questions about the vaccine, this kind of thinking is obviously harmful and should not be a factor in making decisions about this vaccine.

 September 15, 2011  Posted by on September 15, 2011

  3 Responses to “The HPV Vaccine Debate And The Unhealthy Corporatization Of Our Political Process And Public Policy Decisions”

  1. In addition, to all of this week’s political hub bub, SANE Vax Inc. announced last week that 100% of the Gardasil vaccines tested from different lots, manufacturers and from different countries around the world were contaminated with Recombinant HPV DNA – a potential biohazard.

    FDA has been notified via certified letter. We are awaiting their response –

  2. “These were the first vaccines approved for universal use in any age group that clearly cost the health system money rather than saved it…”

    I don’t think this is necessarily true. Consider that if a women does have an HPV infection, she need various follow up procedures, sometimes for many years. My own HPV has cost many hundreds of dollars of treatment, and I don’t even have a severe case.

  3. Alex, that might indeed be so for those who require treatment, but since the vast majority of sexually active women don’t require treatment, as a whole, it just doesn’t add up.

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