Mandatory HPV Vaccines: Who Benefits?

The lure of government mandates has turned Merck, if it wasn’t already, into an unethical company.  In principle, I have nothing against Merck publicizing its products and their benefits.  But Merck has exaggerated the benefits of its Gardasil vaccine and has shamelessly lobbied lawmakers to make a vaccine of questionable benefit mandatory.

At $360, the Gardasil vaccine against four types of human papillomavirus (HPV) is one of the most expensive vaccines on the market. On June 8th of last year the Food and Drug Administration (FDA) approved Gardasil for use in girls age nine to 26.

It is important to mention that technically “mandatory vaccination laws” are not “mandatory” because they all contain constitutionally required opt-out provisions.  Nevertheless when lawmakers, Merck, the press and everyone else call’s such laws “mandatory,” they in effect become so because the public perception is that they are.

Factual Errors.

Merck has misrepresented the facts, or is at least standing by dumb while others misrepresented them.  It is misleading to say the human papillomavirus (HPV) causes cervical cancer.  Not all HPV viruses cause cervical cancer and, while HPV is prevalent, those types (types 16 and 18) that cause cervical cancer are not nearly as prevalent. There are 37 or more types of genital HPV.  The rate of all 37 types together is high – 34% among women ages 14 to 24, but the rate for the types 16 and 18 that are responsible for 70% of cervical cancer cases in the U.S. – is only 1.5% and 0.8% respectively.  See the Journal Watch article published today.

Parts of the “Patient Product Information” link for Gardasil on the Merck website are vague at best and confusing and misleading at worst.   In light of the information above consider these two paragraphs:

What is Human Papillomavirus (HPV)?

HPV is a common virus. In 2005, the Centers for Disease Control and Prevention (CDC) estimated that 20 million people in the United States had this virus. There are many different types of HPV; some cause no harm. Others can cause diseases of the genital area. For most people the virus goes away on its own. When the virus does not go away it can develop into cervical cancer, precancerous lesions, or genital warts, depending on the HPV type. See “What other key information about GARDASIL should I know?”

Who is at risk for Human Papillomavirus?

In 2005, the CDC estimated that at least 50% of sexually active people catch HPV during their lifetime. A male or female of any age who takes part in any kind of sexual activity that involves genital contact is at risk. The U.S., unlike some other countries, has been very successful at reducing cervical cancer rates.  Both the actual number of cases of cervical cancer and the number of deaths from cervical cancer has been declining steadily for the past ten years.  (seer.cancer.gov/statfacts/html/cervix.html).  Furthermore, the effectiveness of condoms in preventing the spread of both HPV and HIV is well documented, as is the value of routine pap smears in preventing death from cervical cancer.

Policy Errors.

Merck is also clearly taking advantage of some very fallacious policy analysis.  It is very difficult to do a cost benefit analysis in public health because there are so many factors, known and unknown, that come into play, but to have the debate ignore considerations that are blatantly obvious is suspect.  While it is horrible that anyone should die of cervical cancer, it probably does not make sense to advocate mandatory vaccination for approximately 30,000,000 school aged girls with a brand new vaccine in order to prevent fewer than two percent of those girls from getting cervical cancer in the future.

Risk assessment is not easy, particularly when, as is the case with Gardasil, the long term effects of a vaccine are totally unknown.  Women who participated in the drug trials were followed for an average of less than three years.  Consider this totally hypothetical example: what if 90% of all school age girls are vaccinated within the next five years and then ten or twenty years from now it is discovered that the vaccine made them sterile or actually caused them to get a different type of cancer than what they were vaccinated against?  Or worse yet, because of the difference in sample size, once millions of  9 and 10-year olds were vaccinated instead of just a couple of hundred, one percent of the girls had side effects severe enough to cause brain damage or death?

The principle of unintended consequences suggests that, in all but the clearest cases, health risk assessments should be left up to individual families, not only because making such determinations rightly rests with families, but also because it simply does not make sense from a public policy standpoint to experiment on such a large portion of our population all at once.  Let parents choose for their girls, then there will be portions of the population that does and that doesn’t get the vaccine and others that received it later or earlier, or yet others that receive it while younger or older.  Allowing parents to make their own risk assessments is a natural way to protect the population from some negative unintended consequence of the vaccine affecting a whole demographic all at once.

To add insult to injury, not only has Merck left policy makers in the dark as to the myriad of possible downsides to mandatory vaccination for HPV, it has actively lobbied and paid large campaign contributions to politicians willing to support mandatory vaccination policies.  According to documents obtained by The Associated Press last month, Merck donated $5000 to Texas Gov. Rick Perry (R) on the same day Perry’s chief of staff met with the governor’s budget director and others for a “HPV vaccine for Children Briefing.”

Similar scenarios played out in at least seven other states.  This seems quite a bit like bribing politicians to do something for Merck, something that will bring Merck huge profits, very possibly at the expense of the general population – or at least at the expense of little girls.

Unfortunately, 20 states or more are currently considering mandatory HPV vaccination laws.