HPV and Gardasil: Wonder Drug or Hoax?

I’m sure by now that most folks have seen the commercial that has been running which promotes the new cervical cancer vaccine (Gardasil) by the Merck pharmaceutical company. If you haven’t (or if you need a reminder), here it is:

I have to admit that it is a very clever spot. Sober minded, active, serious young ladies getting the word out about something wonderful that might just save your life; sistahs’ doin’ it for themselves. Makes you all warm and fuzzy, don’t it? For the most part, being the skeptic of the pharmaceutical industry that I am, I just put off the promo as yet another attempt by the industry to hawk and market some more of their wares through the use of the mixture of a fear and goodwill message in their advertising. That is until the last few weeks when news reports began circulating that many States had proposed legislation (or passed said legislation, in the case of Texas) to make such a vaccine mandatory for all girls 9-16 attending school within their jurisdiction. My ears perked, I decided to investigate a little further into the situation to find out if the drug was what it was purported to be, if there was a need to make such a treatment mandatory, and why industry and government were pushing it so hard on the public.

What Is HPV?
Human Pappilomavirus (HPV) is, according to the FDA’s website, a sexually transmitted disease that is passed on through genital contact. Additionally, a full 50% of all people who ever have sex will get HPV (according to Children’s Hospital Boston, over 20 million people currently have HVP). There are apparently many variations of HPA (about 100 types according to the CDC), many of them have no symptoms whatsoever and generally go away on their own; but there are a few strains of the virus that may actually cause physical problems, such as genital warts, and may even be a cause of cervical cancer in women.

According to a report in the Washington Post, HPV itself is the most common sexually transmitted disease in the country and is responsible for virtually 100% of all cases of cervical cancer. In June of 2006 the CDC issued a recommendation that all women aged 9-26 should receive treatment in the form of a vaccine, Gardasil, that was supposed to stop the onset of HPV (although, not cure it if it was already transmitted).

The Vaccine
Gardasil (Quadrivalent Human Papalomavirus Recombinant Vaccine) is a product made by the Merck Company that is supposed to keep women from getting HPV. According to Merck’s website it is the: “Only vaccine that may help guard against diseases that are caused by HPV types 6, 11, 16, and 18”. According to the site, types 16 and 18 are the cause for 79% of cervical cancer cases and types 6 and 11 are responsible for 90% of all genital warts cases. It is supposed to be given in the form of a series of three injections, spaced a few months apart, in order to get the full benefit from the vaccine. It is recommended for women between the ages of 9 to 26, before they have had any sexual activity, as a preventive measure. Even though one may have had intercourse, one may still get the shots due to the fact that even a sexually active female may not have gotten the four specific types of HPV that the treatment guards against. Side effects, according to Merck, are minimal, mostly concerning irritation at the point where the needle entered the skin and rare cases of some nausea and vomiting.

On the surface, this seems to be a benign situation: a drug company has come up with a vaccine that can actually prevent a form of cancer that targets women, potentially alleviating (and eventually wiping out) the threat of cervical cancer. Going no deeper, one could say that this wonder-drug is somewhat miraculous. But is all as it seems?

The Other Side Of The Coin

First, let’s take a look at the research done to measure the safety and effectiveness of the vaccine. The only studies conducted was the two that Merck did in order to get FDA approval for the drug (it may come as a surprise, but when a company comes before the FDA for a drug approval the only study requirement is that the company that created and is marketing the drug needs to do a study for effectiveness and side effects…no outside sourcing of studies are necessary to get the nod from the FDA) and those study, say some critics, didn’t go far enough. The first review followed the effectiveness of the vaccine over a three years period, which might at first seem like plenty of time to gather information, but the documented tracking of side effects only goes up to 18 months; critics decry if such a treatment is to be made mandatory than the study should have had a heavier focus on any harmful long term side effects, more so if the vaccines might have to be taken multiple times over the course of a child’s life (once for the initial series of three shots, and then a booster of one to three shots every three to four years). Additionally, although 20,000 females were included in the testing (half getting the shots and half getting a placebo) only 100 subjects were aged 9 (the recommended ‘starting’ age for the treatment), which the critics say skews the results of negative effects (as well as effectiveness) in children of that age (there was another study done by the company in which 12,000 females tested the drug, but it was only between the ages of 16 to 26). Critics also worry about the rush to market that Merck Company has employed, citing later evidence that the vaccine additive Thiomersal (added as a preservative to many vaccines from the 1930’ until it was pulled from the US market in 2003) was linked to an increase in cases of autism.

The cost of the shots are quite high or even prohibitive to lower income families. Each shot will cost an average of $120, with the entire series of the three initial shots coming to $360. Although there are some organizations that help lower income families pay for vaccinations, no insurance company has (as of this writing) agreed to cover the cost of the treatment.

Critics also claim that there is no reason to make the vaccines mandatory for anyone, much less for children. Although cervical cancer is a terrible disease, out of the 750,000 cancer deaths reported in the US ever year only 3,700 are from cervical cancer. Additionally, according to the CDC, the rate of reported cases of cervical cancer has dropped nearly 75% over the last ten years. That being said, cervical cancer, while still a killer of women, is not an epidemic by any measure and the vaccination of potentially millions of girls for HPV (Texas and Washington DC have passed legislation to make Gardasil part of children’s vaccination schedule, and 26 more states have legislation pending) is simply not warranted (for perspective purposes, over 150,000 people die from the flu – or flu related symptoms, such as pneumonia – every year in the US, but the flu vaccine is not mandatory).

Many conservative critics who decry making the vaccine mandatory state that they believe that the administering of this vaccine will encourage sexual promiscuity in teenaged female students.

Additionally the methods used by Merck to ‘raise public awareness’ through their ad campaign, as well as their lobbying efforts, have come under scrutiny. In addition to a years worth of heavy-rotation commercial spots, the Merck company spent millions of dollars through private lobbying companies as well as through an organization called Women in Government (a bi-partisan, non-profit organization chaired by women who hold positions in government; critics claim an inherent bias in that fact that Merck made heavy donations to this organization which included among its membership and board of directors many women involved in state and federal legislation). Also, if the vaccine is put on the vaccination schedule list for school-children, it is automatically folded into the National Childhood Vaccine Injury Act (which is legislation which protects vaccine manufacturers of any ‘mandatory’ shots from liability from any adverse effects of their products)


The Company

Merck pharmaceuticals got its start in 1891 as an American subsidiary of a German parent company (Merck KAgA, primarily a chemical manufacturer). During WWI, along with many other German companies at that time, it was confiscated by the US government and set up as a private corporation. Now, the company counts itself as one of the five largest pharmaceutical companies in the world. In addition to making drugs, the company also owns the Merch Manuel of Diagnosis and Therapy (a major tool used by doctors to make diagnoses) and the Merck Index (considered the bible of chemical compounds).

Over the years the company has had its share of legal troubles with some of the drugs that it has brought to market, most recently (and most publicly) was the flap a few years back over their offering, Vioxx. In 1999 the FDA approved the use of Vioxx for the treatment of arthritis; soon after the drug became one of the most prescribed drugs in history. In 2001 there was some speculation that the drug greatly increased the risk of heart attacks; the company reacted by conducting a study of the drug which concluded that there was no connection to Vioxx and increased heart disease – nonetheless they adjusted the warning label on Vioxx to include a warning of a possible risk. In 2004 Merck withdrew Vioxx from the market due to concerns of it increasing the risk of heart disease (even though the FDA still approved the drug but recommended that more prominent warnings should be placed on the label of the drug). Later that same year the esteemed medical journal, The Lancet, published a report that Merck had full knowledge of Vioxx’s side effects on the heart as early as 2000, and publicly condemned the company for keeping the drug on the market even after they knew that it posed a serious health threat. In August of 2006, Merck lost a suit brought against them by the family of a man who had taken Vioxx and died of a heart attack; the court awarded them over 250 million dollars (later reduced to 20 million, the maximum payout according to Texas law). A the time of that case, Merck was fending off another 4,000 lawsuits that had been brought up against them due to their keeping Vioxx on the market after they knew it was extremely harmful.

Conclusion

Personally, I have no problem with a company releasing a drug to market that might just save thousands of lives (although I do indeed have a problem with the way said approval is gotten for those drug by the FDA). But it seems to me that it is excessive, to say the least, to make such a treatment mandatory for school children…more so when the potential long term side effects are a big question mark. And considering that this drug is being released by a company already caught recently keeping drugs on the market that it knew were dangerous, diminishes the credibility of the company and its claims that the vaccine had been thoroughly tested and is indeed safe. Add to that the amount of money and effort spent on lobbying for legislation to make the vaccine part of a child’s shot schedule (and, in turn, protecting the company from lawsuits that may arise due to harmful effects of the vaccine), and I think one could make a case that what we may be witnessing is blatant corruption and collusion between our elected representatives and private industry.

Am I saying that the vaccine is bad, or that no one should take it? Of course not…I’m not a doctor, nor do I play one on TV. But I do have to voice a serious concern about what appears to be a situation where all is plainly not as it seems, and justifiable doubt in our legislators and pharmaceutical companies.

Cited Works

ARTICLES:
Washington Post Article: http://www.washingtonpost.com/wp-dyn/content/article/2006/07/17/AR2006071700955.html
New York Times: http://query.nytimes.com/gst/fullpage.html?sec=health&res=9E06E7DF163FF93BA25754C0A9609C8B63
AP story : http://www.feed24.com/go/41243720
NPR: http://www.npr.org/templates/story/story.php?storyId=7190905
Lawrence-journal: http://www2.ljworld.com/news/2007/jan/26/bill_would_require_hpv_shot_girls/?kansas_legislature
CBS news: http://www.cbsnews.com/stories/2007/01/26/eveningnews/main2403795.shtml
Kaiser: http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=42775

MERCK:
Gardasil Home page: http://www.gardasil.com/
Merck info:

FDA and CDC:
Causes of Death in the US (pdf): http://www.csdp.org/research/1238.pdf
Health Statistics: http://www.cdc.gov/nchs/fastats/lcod.htm
CDC faq on HPV: http://www.cdc.gov/nip/vaccine/hpv/hpv-faqs.htm
FDA page on Gardasil: http://www.fda.gov/cber/label/hpvmer060806LB.htm

OTHER:
HPV: http://en.wikipedia.org/wiki/Hpv
National Childhood Vaccine Injury Act: http://en.wikipedia.org/wiki/National_Childhood_Vaccine_Injury_Act
Children’s Hospital Boston: http://www.childrenshospital.org/views/december06/breakthrough_hpv_vaccine.html
Thiomersal: http://en.wikipedia.org/wiki/Thiomersal
Women in Government: http://www.womeningovernment.org/home/

Other Works
Web MD: http://www.webmd.com/content/article/123/115100

Annals of Internal Medicine article on over-prescription of drugs: http://www.annals.org/cgi/content/full/127/6/429