There is one unavoidable problem with universal healthcare, the centerpiece of Hillary Clinton's political platform.   Universal healthcare takes medical decisions out of the hands of trained professionals and makes far too many of these decisions a matter of politics.   Some might disagree with that prognosis but those whose profits are directly effected, the pharmaceutical companies, know otherwise.   A case in point is HPV vaccine, Gardisil, marketed by Merck.

According to Wikipedia, cervical cancer "is the fifth most deadly cancer in women.   It affects about 1 per 123 women per year and kills about 9 per 100,000 per year."   As of the date of this writing, Wikipedia's site makes no mention of serious side effects of Gardisil.   Rather, it cites US Centers for Disease Control and states, "the vaccine was tested in over 10,000 females (ages 9 to 26).   These studies have shown no serious side effects. The most common side effect is soreness at the injection site."   Even WebMD says, "Reports from clinical trials, to date, show Gardasil to be safe."

Merck's marketing efforts have focused on lobbying.   The company understands that there is no Viagra-like TV commercial for the general public which will turn the drug into the giant it needs it to be.   Rather, its hopes are that governments will mandate its use as a requirement before children are allowed to attend public school.   To this end, it is spending huge amounts of money to push states towards eventually making its use mandatory as a matter of public health policy.   The Wiki article lists the status of legislation in the various states including numerous pending bills, a few passed by legislatures but some of those vetoed and some signed by governors.   Merck has officially halted its efforts to get state legislatures to require 11- and 12-year-old girls to get the three-dose vaccine as a requirement for school attendance.   But that has to do with conservative parents and politicians concerns regarding HPV's status as a sexually transmitted disease.

The fact is it is hugely expensive for Merck to fight this battle state by state.   Universal healthcare would uncomplicate that.   A single centralized governmental agency would make the battle relatively simple, and cheap.   But how would an easy road to mandating the use of Gardasil effect you?   And why should you be concerned?

The first questions you should ask are:

1) Is cervical cancer really such a huge killer that we should be all-consumed with its eradication?

2) Is Gardisil the only answer to wiping out a huge killer of women?   Is it the most cost effective answer?

3) Are there no side effects we ought to consider before sheepishly following the crowd and getting our young daughters vaccinated?

Before I begin answering these questions, let me explain that I have high regard for the many miracles medical science has provided us over the past decades.   The field is singularly responsible for shooting life expectancy into the stratosphere.   Illnesses which routinely led to death just 100 or so years ago are today nothing more than minor inconveniences.   Also, I advocate a generally less careful approach to pharmaceutical approval than our FDA practices.   I believe when you view the pluses and minuses of approving drugs, you have to consider not just those who are negatively effected by drugs which have been less than fully vetted, but also the benefits forgone when drug approvals are held up for decades in order to conduct exhaustive pre-approval screenings.   It is a difficult tightrope to walk but a huge part of the cost of medicines includes the cost of the approval process.   With these things in mind, I hesitate to criticize a medicine which holds such huge promise for so many.   What bothers me most is not so much that the pharmaceutical industry is aggressive about promoting its products but that if we lived under a universal healthcare regime, it would be a small matter for companies like Merck to force us into such medical decisions.

The occassion of my writing about Gardasil is somewhat complicated and involves mostly anecdotal evidence.   It begins with a friend of the family attending a routine follow-up doctor visit for her newborn.   While she was waiting for a physician, there was significant activity in an examination room.   A 12 year old was being vaccinated when she fainted and suffered a "tremor," what the nurse referred to as a "mild seizure."   Later during our friend's doctor visit, the nurse mumbled to a co-worker in reference to the "mild seizure," "that's the fourth one today."

I thought this description of events might be an exaggeration or perhaps some sort of isolated incident.   Maybe the use of the word seizure by the nurse was a bit overstated.   I've personally seen both seizure-like occurences and real seizures take place.   Sometimes it isn't particularly easy to differentiate though the implications of each are drastically different.   Or maybe the incident was accurately reported but I imagine this would have been isolated since I haven't heard anything much about these types of things on nightly news reports

So I set out to see if I could find anything online.   I searched Google for "Gardasil side effects seizure" and was astounded at the volume of web pages I discovered.   One blog, in particular, has raised a few eyebrows with its reports of serious Gardisil side effects.   Read it for yourself but some of the most salient comments include:

May 2007 - Judicial Watch excerpted the VAERS database entries for Gardasil and posted them as .pdf file on the web; there were 1,637 adverse reports that seem to run through the first couple of days in May. I haven't had a chance to read it in detail but here are the incidence of some scary terms:

149 - Hospitalized
53 - Permanent Disability
239 - Syncope (loss of consciousness)
99 - Neuro (includes references to neurologist, neurological, neuro exam)
7 - Guillian-Barre

If you want to read further information regarding the many serious questions concerning Gardasil, try these web sites:

• "10 THINGS YOU MIGHT NOT KNOW ABOUT GARDASIL "
  
• Gardasil Lawsuits
  

Also, please check out this coverage of a release by the National Vaccine Information Center (NVIC) which reported 385 individual GARDASIL adverse event reports made to the federal Vaccine Adverse Event Reporting System (VAERS) during the last six months of 2006.   The piece notes that "VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health care providers report vaccine adverse events.   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 ... which were never reported."   NVIC's President, Barbara Loe Fisher, wondered "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?"

Note that if Merck's marketing efforts were able to get the vaccine to be part of the federal vaccine liability program, something that will happen if the states adopt a requirement for its use before school, the company will not be liable if Gardasil turns out to be harmful.   That seems to have been a driving force of the marketing effort.   That process could be shortened if universal healthcare were adopted.

Looking a bit further, I came across a NY Times article in the Health section which discusses Gardasil.   The article is not concerned with side effects but talks quite a bit about cervical cancer and Gardasil, while wondering, "Should It Be Compulsory."   The author notes, "Cervical cancer has gone from being one of the top killers of American women to not even being on the top 10 list.   This year cervical cancer will represent just 1 percent of the 679,510 new cancer cases and 1 percent of the 273,560 anticipated cancer deaths among American women ... According to the American Cancer Society Web site, 'Between 1955 and 1992, the number of cervical cancer deaths in the United States dropped by 74 percent' ... A simple, quick, relatively noninvasive test (Pap Smear) that's part and parcel of routine preventive health care for women ... provides early warnings of cellular changes in the cervix that are precursors for cancer and can be treated ... Because even if you have the new vaccine, which protects against only some of the viral strains that may bring on cervical cancer, you still need to continue getting Pap smears."   In other words, cervical cancer is not that prevalent, its incidence is going down thanks to other, less costly alternatives, and those alternatives are necessary anyways.

My conclusions are: there is a huge effort to market a vaccine intended to wipe out a disease that has been effectively treated in other ways.   That marketing is focused on lobbying.   If there were universal healthcare, Hillarycare, if you will, that marketing effort would be simplified.   There are significant, serious and fairly common risks to the vaccine.   And cervical cancer is not quite at epidemic levels.   Actually it is effectively being tamed by medical procedures which are otherwise needed.

When you contemplate politics, consider the current popularity of so-called universal healthcare.   Consider that adoption of socialized medicine would place a huge amount of power into a single politically influenced body which might be easily swayed by the powerful pharmaceutical companies.   Consider how much easier it would have been for Merck to shove Gardasil down our throats if it only needed to fund federal election campaigns.

Now, consider that fiction writers and movie makers want you to fear a mythical day in the future when the country is under the control of an ultra-right-wing government and as yet unknown biological agents have made most women infertile.   Juxtapose that against a day much sooner when the country will be controlled by ultra-left wingers who have shoved universal healthcare down our throats, mandated the use of Gardasil, and women are infertile thanks to a side effect that was never even considered.   One of the above is a fictional work.   The other is, shall we say, a little more realistic.

Labels: Hillary, universal healthcare