The United States Constitution

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Location: Middleton, Massachusetts, United States

I am concerned about the direction of the United States economy and politics, and about our declining influence in the world. I feel we are losing our moral and ethical bearings.

Monday, February 12, 2007

Can the Governor of Texas Force 11 Year Old Girls to be Vaccinated Against HPV?

Rick Perry, the Governor of Texas, signed an executive order that requires all Texas schoolgirls entering the 6th grade to be vaccinated against Human Papilloma Virus (HPV).


Here is the text of Governor Perry's order. Governor Perry claims he has the authority to do this because:



NOW THEREFORE, I, RICK PERRY, Governor of Texas, by virtue of the power and authority vested in me by the Constitution and laws of the State of Texas as the Chief Executive Officer, do hereby order the following:


Vaccine. The Department of State Health Services shall make the HPV vaccine available through the Texas Vaccines for Children program for eligible young females up to age 18, and the Health and Human Services Commission shall make the vaccine available to Medicaid-eligible young females from age 19 to 21.


Rules. The Health and Human Services Executive Commissioner shall adopt rules that mandate the age appropriate vaccination of all female children for HPV prior to admission to the sixth grade.


Availability. The Department of State Health Services and the Health and Human Services Commission will move expeditiously to make the vaccine available as soon as possible.


Public Information. The Department of State Health Services will implement a public awareness campaign to educate the public of the importance of vaccination, the availability of the vaccine, and the subsequent requirements under the rules that will be adopted.


Parents' Rights. The Department of State Health Services will, in order to protect the right of parents to be the final authority on their children's health care, modify the current process in order to allow parents to submit a request for a conscientious objection affidavit form via the Internet while maintaining privacy safeguards under current law.



The vaccine, Gardasil, is manufactured by Merck, one of the largest drug companies in the world and a significant contributor to Governor Perry's political campaigns. Merck is the same company which hid the deaths from heart attacks and strokes associated with its anti-arthritis drug, Vioxx, forcing Merck, under pressure, to pull Vioxx from the market.


According the the Merck-sponsored Web site, gardasil.com,



GARDASIL is the only vaccine that may help guard against diseases that are caused by human papillomavirus (HPV) Types 6, 11, 16, and 18:

• Cervical cancer

• Cervical abnormalities that can sometimes lead to cervical cancer

• Genital warts



HPV Types 16 and 18 cause 70% of cervical cancer cases, and HPV Types 6 and 11 cause 90% of genital warts cases. What about the other 30% of cervical cancer cases? Doctors still recommend a Pap test - a far cheaper and more effective way of detecting early cervical cancer. Also certain types of HPV cause anal cancer, which would lead one to conclude that boys who might potentially engage in homosexual acts should also be vaccinated.


Another interesting tidbit is that millions of us - just about anyone who has had any kind of sexual contact on a regular basis - have been exposed to HPV, without any side effects. For most of us, our body has natural defenses against HPV, once exposed. There's no way of knowing who has these defenses and who does not. If that weren't true, then there would be many, many more cases of cervical cancer than there actually are. Merck's commercials play on fear - even one case is too many. Of course, that is true, IF there's an open and shut case that Gardasil will actually prevent even one case. This is far from proven, at this stage of the game.


Note the waffling in the Merck claim, especially the use of the phrase "may help guard against". HPV is not one virus, but one of a family of at least 100 different strains of the virus. The vaccine is targeted at only 4 types of HPV - types 16 and 18, which may cause 70% of cervical cancer cases, and types 6 and 11, which may cause 90% of genital warts cases. There are a dozen types of HPV that may be involved with cervical cancer. Gardasil only targets two of them. This, of course, begs the question of whether if in the future, Merck or some other company develops a "vaccine" against the other 10 types of HPV, should these be mandatory as well? And what about specific vaccines against other cancers? How many shots will the states expect our children to receive before they will become stuck with so many needles their arms will look like pincushions? And what about the side effects - these have not been sufficiently explored yet. Is an epidemic such as Gullian-Barre syndrome - a result of the Asian flu vaccine side effect - in our future?


According to the about.com cancer site, Gardasil will cost between $300 and $500 per shot, which will be covered by Federal programs. Gardasil is the most expensive vaccine ever marketed in the United States. This is, of course, quite a bit of revenue for Merck, even if only Texas mandates the vaccine for every 6th grade girl. Gardasil was approved by the Centers for Disease Control (CDC) on June 8, 2006, specifically for girls. According to the CDC, not enough information is available to decide whether Gardasil should be given to boys as well.


The idea is that HPV is linked to the possibility of developing cervical cancer, that HPV is spread by sexual contact, and that vaccinating girls against this virus (vaccinating 6th grade boys apparently was not considered, though in most cases boys are involved as well as girls) will somehow prevent cervical cancer. Here are Governor Perry's words:



As governor of Texas, I will do everything in my power to protect public health. The executive order I signed last Friday will help stop the spread of human papillomavirus (HPV) and prevent cervical cancer in young women.


Some are focused on the cause of this cancer, but I remain focused on the cure. And if I err, I will always err on the side of protecting life.


If we could stop lung cancer, would some shy away claiming it might encourage tobacco use? This is a rare opportunity to act, and as a pro-life governor, I will always take the side of protecting life.



Merck is carrying on a massive lobbying effort for states to require women as young as 11 or 12 to undergo Gardasil vaccination. Here's a quote from the article:



Merck & Company is lobbying to have states pass legislation that would require women as young as 11 or 12 years of age to be “immunized” against a cervical cancer virus with a new drug recently approved by the FDA called Gardasil. At least 18 states are taking this initiative seriously enough to debate it. Michigan has already voted it down. But look at what they’re doing:


A top official from Merck’s vaccine division sits on the Women in Government business council, and many of the bills around the country have been introduced by members of Women in Government.


“Cervical cancer is of particular interest to our members because it represents the first opportunity that we have to actually eliminate a cancer,” Women in Government President Susan Crosby said. Here's a quote from the Women in Government Cervical Cancer position paper:



An HPV test is now available to detect high-risk types of the virus. When used in conjunction with a Pap test in women over 30 and older a doctor's ability to determine which women need early intervention increases to almost 100%.


I asked my son, who is a family practice physician and has researched this issue about this. He told me that the above statement is misleading because the Pap test remains the way to diagnose cervical cancer. The HPV "vaccine" does not add any certainty to the diagnosis. This is how lobbyists sow confusion among lawmakers.



Other states are jumping on the Gardasil bandwagon. In Arkansas, Dr. Jim Phillips, Director of Infectious Diseases at the Arkansas Health Division, voiced strong opposition to mandatory HPV vaccinations because it would encourage parents to opt out of all mandatory vaccinations. This, even though the Arkansas Cervical Cancer Task Force recommended mandatory HPV vaccinations for all girls age 9 to 12. There's enough Federal money to fund vaccines for uninsured Arkansas girls. However, if you can pay the $300 through your health insurance, Arkansas will force you to fork up the money.


In Virginia, Delegate Phillip Hamilton (R-Newport News) sponsored a bill - HB1914 - that would make it mandatory for all middle school girls to be vaccinated with Gardasil. As in other states, parents could opt out of the program by filling out a form.


The Roanoke Times editorial of February 7, 2007, opposes the measure. Here's a partial quote:



That should raise questions about the influence of Merck & Co., makers of the vaccine, called Gardasil.


Those questions are being asked in Texas, where last week Gov. Rick Perry signed an order requiring girls entering the sixth grade to get Gardasil beginning in September 2008.


His action sidestepped opposition in the Texas legislature and from some conservatives and parents' rights groups. They worry that the requirement would condone premarital sex -- since the viruses it protects against are sexually transmitted -- and interfere with how they raise their children.


Perry has ties to Merck. His former chief of staff is a lobbyist for the company, and Perry also received $6,000 from Merck's political action committee during his re-election campaign.


Merck has stretched its reach into other states considering similar laws, including Virginia. Since 1996, Merck has donated nearly $200,000 to candidates and political action committees in Virginia. Merck has given the House sponsor, Del. Phillip Hamilton, R-Newport News, $10,000 in the last decade.


Contrary to the fears of some, 10- and 11-year-old girls aren't likely to assume that this series of shots equates with permission to engage in premarital sex. That is not a good argument to oppose Merck's efforts to mandate the vaccine.


But there are others. While dangerous side effects aren't as likely with vaccines as with other drugs, such as Merck's Vioxx, it would still be prudent before making the vaccine mandatory to see whether any emerge now that it is in widespread use.


Also, many pediatricians and gynecologists aren't stocking the vaccine because they say insurance companies aren't adequately reimbursing them.


Finally, this premature move could blunt other companies' efforts to develop competing vaccines.


The finding that Gardasil protects against four HPV types, which together cause 70 percent of cervical cancers, is a breakthrough. But maybe one of Merck's competitors could improve on Gardasil's performance if Merck doesn't use legislation to prematurely corner the market.


Merck should spread the gospel of Gardasil, and let the health community and parents know of the vaccine's potential in the fight against cancer.


State legislators should not ignore that Merck stands to make billions in sales if Gardasil becomes mandatory across the country.


Merck's interests are served by mandating the vaccinations. Legislators should ensure that public health would also be served.


Campaign contributions aside, that argument has not been made convincingly.



Doctors are resisting stocking up on Gardasil, according to this Chicago Tribune article. In particular:



But in the real world, Gardasil is getting used less than doctors would like. Pediatricians and gynecologists across the nation are refusing to stock Gardasil because of its $360 price for the three doses required and "totally inadequate" reimbursement from most insurers.


Pediatricians, in particular, are rebelling, fed up after years of declining insurance reimbursement for vaccines, an explosion of new vaccines and fast-escalating vaccine prices.


Many practices must tie up $50,000 or more in vaccine inventory, insure the vaccines and spend lots of time on inventory management. They also must absorb the cost of broken or wasted vials, and they say that's not possible with most insurers reimbursing at just $2 to $15 over the $120 per dose charged by Gardasil's developer, Merck & Co.



This action raises both constitutional and health issues, such as:



  1. Can the Governor of Texas issue such a decree even though the legislature is in session? It's news to a number of Texas legislators that the governor can rule by decree. Texas is not in any state of emergency. Governor Perry simply bypassed the legislative process in issuing his executive order.

  2. Is mandatory vaccination allowed under the Texas Constitution? Governor Perry cites his executive powers as justification for his decree. Perhaps. If the legislation was not in session, and there was an imminent outbreak of something like bird flu that was a direct attack on public health, perhaps there would be no time for legislative deliberation. Given that the implementation of this decree is not supposed to occur until 2008, the "time is of the essence" argument doesn't seem to hold water. Why not dispense with the legislature altogether and just rule by decree, as dictators are accustomed to doing?

  3. Is mandatory vaccination allowed under the United States Constitution? There is a constitutional conflict here because under the reserved powers clause, and in general, matters of public health are traditionally state matters, under the state's "police power". However, if there is an affect on interstate commerce, mandatory vaccination could be in the province of the Federal government.

  4. Would the United States Supreme Court declare this particular decree unconstitutional, or perhaps require mandatory vaccinations? Who knows? The Court, especially these days, would probably allow a state to do what it deems best for the health and welfare of its citizens. If Pennsylvania requires doctors to jump through all sorts of hoops before performing an abortion, so be it. If Oregon wants to allow for medically assisted suicide, that might work as well. The Court could very well contribute to Merck's profits by upholding laws, pending in 18 states, forcing 6th graders to submit to the Gardasil vaccine, whether or not all the facts are in.