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GARDASIL REVISITED

September 22, 2011

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This Blog had some critical comments to make about Governor Perry’s Executive Order mandating the innoculation Texas school girls with the Gardasil vaccine at the time he issued his EO.  Now that a fully detailed explanation of that EO and the controversy surrounding it has be made available, I am happy to post it here:

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The Whole Pesky Truth about Rick Perry and Gardasil/HPV

garnet92 | September 22, 2011 at 12:18 PM | Categories: Political | URL: http://wp.me/pL408-7A

Rick Perry’s detractors are doing their best to keep this issue alive, even though most of the related accusations have been proven false.

While it is certainly appropriate that some will downgrade Perry because of his Executive Order (EO) mandating that the HPV vaccine be administered to Texas school girls, Perry’s EO was overridden by the Texas legislature and never went into effect. Although he has admitted his lapse of judgment, he did it, it was wrong, and now, as a presidential candidate, he’s taking the heat for it.

But, some media portrayals of the particulars surrounding Perry’s actions have been either completely false or misleading. That is the reason for this document. Voters need to know the truth about the influence by his former chief of staff (later a lobbyist for Merck), about Perry getting a $30,000 contribution from Merck (to “buy” his endorsement), and the dangers of the vaccine itself.

Please read on and when you feel the need, click on any of the numerous links to access supporting sources.

1. About Gardasil

The Gardasil vaccine is produced by Merck & Co., Inc. It is called a quadrivalent vaccine because it protects against four HPV types: 6, 11, 16, and 18, and is thought to prevent cervical cancer caused by the Human Papilloma Virus (HPV). Gardasil is given through a series of three intra-muscular (IM) injections over a 6-month period.

The U.S. Food and Drug Administration (FDA) approved Gardasil for use in females for the prevention of cervical cancer, and some vulvar and vaginal cancers caused by HPV types 16 and 18. Gardasil is also approved for the prevention of genital warts caused by HPV types 6 and 11. Merck announced FDA approval of the drug on June 6, 2006.

There is a second HPV vaccine, Cervarix, produced by GlaxoSmithKline (GSK) which competes with Gardasil when considering options in the prevention of cervical cancer. To be fully informed, you must be aware that Merck had a competitor (in GlaxoSmithKline) fighting for a similar stake; inoculating school girls against cervical cancer.

The Cervarix vaccine is called a bivalent vaccine because it targets two HPV types: 16 and 18. This vaccine is also given in three doses over a 6-month period. The FDA has approved Cervarix for use in females ages 10 to 25 for the prevention of cervical cancer caused by HPV types 16 and 18. Cervarix is not approved for the HPV types 6 and 11 that are covered by Gardasil.

It is important to note that the technology was not developed by Merck or GSK, both Gardasil and Cervarix are based on technology developed by National Cancer Institute (NCI) scientists. NCI licensed the technology to the two pharmaceutical companies (Merck and GSK) to develop HPV vaccines for widespread distribution.

Back to Gardasil.

Gardasil went under evaluation in four placebo-controlled, double-blind, randomized clinical studies. The studies reviewed and documented the results from 20,464 women ages 16 to 26 exposed to the drug. Study information source: from the ACIP meeting minutes. A link is provided later in this document.

Study participants were then followed for up to five years. In one extensive clinical study performed prior to FDA licensing, the vaccine was 100 percent effective, a virtually unprecedented result. Another study appearing in The New England Journal of Medicine in 2007 found that Gardasil was again nearly 100 percent effective in preventing precancerous cervical lesions caused by the strain that Gardasil protects against.

Gardasil’s effectiveness increased when given to girls and young women before they become sexually active. Gardasil was found to be extremely effective in preventing several of the strains of HPV known to cause cervical cancer (types 16 and 18) and genital warts (types 6 and 11). Cervical cancer is the second leading cancer killer of women worldwide.  In the United States, nearly 10,000 women are diagnosed with cervical cancer each year and 3,700 women die.

Gardasil is administered in three 0.5 milliliter intra-muscular injections over six months. The second injection is two months after the first, and the third injection is four months after the second shot. Each injection costs $120, bringing the total cost for immunization to $360 per person.

In June 2006, The Advisory Committee on Immunization Practices (ACIP) recommended administering the vaccine to girls between 11 and 12 years of age.

Who/what is ACIP? The Advisory Committee on Immunization Practices (ACIP) consists of 15 experts in fields associated with immunization. These experts have been selected by the Secretary of the U. S. Department of Health and Human Services to provide advice and guidance to the Secretary and the Assistant Secretary for Health, and the Centers for Disease Control and Prevention (CDC) on the control of vaccine-preventable diseases.

2. Perry’s Executive Order

As a result of the ACIP recommendation on HPV vaccination, numerous state legislatures began introducing legislation focusing on this emerging public health issue. On November 14, 2006 Representative Jessica Farrar (D-Houston) filed HB 215 in the Texas House mandating the HPV vaccine be administered to girls “at an appropriate age” as a requirement to enroll in school. Bill HB 215 was first read on January 30, 2007 and sent to the Public Health Committee that same day.

Senator Leticia Van de Putte (D-San Antonio) who sat on the Senate Committees on Education, State Affairs, and Business and Commerce also filed identical companion legislation, SB 110, the same day in the Senate.

But the legislation ran into trouble in the House. After working for months to build support for the bill, Representative Farrar and Governor Perry were informed that the bill would not be read in committee. That meant that it was not likely to pass the Texas House.

Three days later, on February 2nd, Governor Perry issued an Executive Order (EO) mandating the vaccine. The EO came as a surprise to the legislators and the public alike.

And that’s where the plot thickens.

Governor Perry’s Executive Order (RP#65, February 2, 2007) followed the wording of the original House bill and mandated that all Texas girls be vaccinated prior to their admission to the sixth grade. Here’s the press release issued by the governor’s office announcing his action. With his EO, Texas became the first state to mandate the vaccination.

The decision was not well received by the Governor’s conservative base as it dealt with the issue of sexual health. Since the vaccination protects against sexually transmitted infection (STI), religious conservatives argued that mandating it could promote pre-marital sexual relations among young girls. Parents’ groups were concerned that the decision interfered with parental discretion.

This is one of the three major concerns that critics have relating to Perry’s Gardasil issue: mandating the vaccination by EO, bypassing the legislature. Even though parents were allowed to opt out of the mandate by filling out an affidavit, both the legislature and conservatives were up in arms.

Two days after signing the executive order, and in response to the wave of opposition, Governor Perry issued this statement, “Providing the HPV vaccine doesn’t promote sexual promiscuity anymore than providing the Hepatitis B vaccine promotes drug use. If the medical community developed a vaccine for lung cancer, would the same critics oppose it claiming it would encourage smoking?”

Perry was rebuked by both houses of the Texas legislature (for example: House Bill 1098, summary here) which nullified his EO by removing the requirement for a student to be vaccinated for HPV in order to enroll.

Sensing the wave of torches and pitchforks to come, Perry did not sign the law nor did he veto the overriding legislation. He subsequently rescinded RP#65 with another EO (RP#74)and the mandate issue is now dead in Texas.

Perry maintains that the justification for his executive order making the shot mandatory was twofold: 1.) that the vaccine offered a chance to save lives that might have otherwise been taken away by cervical cancer and, 2.) that insurance companies wouldn’t cover the $360 cost of the vaccine ($120 for each of a 3-shot regimen) when it was simply an optional recommended vaccine. That put it out of the reach for most low-income Texans. Both justifications are, taken alone, valid reasons for Texas to promote Gardasil vaccinations for young women.

When Perry mandated Gardasil, it was expected to become part of a school-related vaccine package which would be covered by insurance for simply the cost of a co-pay.

Perry has since confessed that his EO was an error in judgment and has admitted his mistake. During a speech in August 2011, when a voter in New Hampshire confronted Perry on the Gardasil issue, here’s what he said: “I signed an executive order that allowed for an opt-out, but the fact of the matter is I didn’t do my research well enough to understand that we needed to have a substantial conversation with our citizenry,” he said. “I hate cancer. Let me tell you, as a son who has a mother and father who are both cancer survivors.”

Perry said he’d invested government resources in cancer cures, adding, “I hate cancer. And this HPV, we were seeing young ladies die at the early age. What we should have done was a program that frankly should have allowed them to opt in or some type of program like that, but here’s what I learned — when you get too far out in front of the parade, they will let you know. And that’s exactly what our legislature did.”

While some may disagree with Perry’s methods, many in the medical field still support a mandate and believe that with education on the issue, more people will see the three-shot vaccine’s benefits.

In effect, Perry was reprimanded by the overriding legislation and by the reaction of the public. He says that he recognizes his mistake and has learned from it. You be the judge.

3. Merck’s lobbyist (Perry’s former top aide)

Another of the concerns that critics raise is related to Perry’s former chief of staff, Mike Toomey, being a lobbyist for Merck at the time of the EO.

For three decades, Toomey was an Austin, Texas fixture, having been a three-term state representative, he was also chief of staff to Governor Bill Clements (1989-1990) and later to Perry (Nov 2002 – Sept 2004); he was a deeply connected Republican lobbyist. He continued to have a personal relationship with Governor Perry after resigning as chief of staff.

When Perry signed the Gardasil executive order, Toomey was a lobbyist for Merck, the vaccine’s manufacturer, and he was suspected of having undue influence on Perry on behalf of Merck’s drug. Opponents cried foul; in response, the governor’s office maintained that Toomey’s input played no part in the decision.

Did Toomey lobby the governor on the Gardasil issue? No doubt, that’s what a lobbyist does. Would he have had the governor’s ear? Again, no doubt. They had a close working relationship for several years. Would Perry simply do a “favor” for his friend? That is doubtful unless Perry was already convinced that the vaccine was the right thing to do.

Regardless of Toomey’s level of persuasion, it is more likely that another person did influence his decision (and carried a lot more clout), Perry’s own in-house consultant, his wife Anita.

The First Lady was very aware of the Gardasil issue and we can assume that Perry would have relied on her education (Masters of Science in Nursing from the University of Texas), and her experience, having worked in the nursing profession for more than 17 years. She worked in surgery, pediatrics, intensive care, administration, teaching and as a consultant.

That Anita was intimately involved in the issue is evidenced by the fact that she was the keynote speaker at a Women in Government (WIG) conference on cervical cancer prevention and elimination. Here are her conference remarkswhich clearly reflect her activism relating to cervical cancer and HPV. WIG is a bi-partisan, non-profit, educational association founded in 1988 for elected women in state government.

Following are some excerpts from her presentation: “More than 1,100 women were diagnosed with cervical cancer last year in Texas.  Today, I am confident that through our efforts like we’ve seen in Texas and the work at this conference, we will see that number decrease.” “Governor Perry has continued to focus attention on women’s health and has made building a healthy Texas a priority.

She continued, “A bill, championed by Rep. Delisi, requires Texas’ Department of State Health Services in collaboration with the Texas Cancer Council and others to develop a strategic plan (.pdf) for eliminating cervical cancer mortality by the year 2015.”

“Another bill addresses pap tests and similar diagnostic testing for HPV making sure that these screenings are covered under health insurance plans.”

Governor Perry took a political risk when he issued the Executive Order mandating Gardasil, but one can see how Anita’s influence may have played a major part in his decision. It’s likely that she influenced the governor far more than Toomey did.

4. Merck’s campaign contributions

This is the third of the accusations made by Perry’s critics relating to the Gardasil/HPV issue. During the September presidential debate in Tampa, Rick Perry acknowledged receiving $5,000 from Merck & Co. (Gardasil’s manufacturer) in 2006. That was shortly before his executive order which was issued in February, 2007. We can see the $5,000 contribution in this propublica list of the donations made to Rick Perry, along with another $1,000 as well (that’s seldom mentioned). Regardless of whether the total for 2006 is $5,000 or $6,000, it is still a relatively small contribution.

To put the Merck contribution into context, it amounted to .025 percent (a quarter of one percent) of the $24,000,000 campaign funds that Perry collected in 2006 – hardly a significant enough reason to influence the governor to take a major political risk.

But here is a troubling issue: In the past week, reports have become rampant that Perry actually received $30,000 from Merck – with no mention of the timeframe, thus giving the impression that Perry got a $30,000 contribution from Merck. An apparent quid pro quo? This is an intentionally misleading statement and one where the obvious intent is to persuade the reader that Perry’s mandate was “bought” for $30,000.

Perry never received a single $30,000 contribution from Merck – period – it never happened.

Here are the facts: Merck contributed 6 times to Rick Perry in the period from 1998 through 2010 for a total of $28,500 (not $30,000). They contributed $5,000 in 2002, $10,000 in 2004, $6,000 in 2006, $2,500 in 2008, and $5,000 in 2010. Merck contributed a total of $28,500 to Perry in 13 years (as far back as the ProPublica records go).

To imply a quid pro quo between a contribution made in 2002 or 2004 (before Gardasil was even available) and Perry’s 2007 EO is more than a stretch, it is ludicrous. And the same can be said for $5,000 contributed by Merck in 2010 (three years after the EO mandate was overturned) is just as ridiculous. Merck made a contribution to Perry (and many others) periodically – in this case, every two years.

Consider what this says about those making that accusation – they are intentionally lying to create an incorrect perception that Perry took a $30,000 payoff in exchange for his 2007 EO.

Was Merck’s contribution to Perry unusual? Not at all. Here’s a news flash: Merck gave $2,460,000 to politicians in 40 states during the seven years from 2000-2006. Any objective analysis of Merck contributions to political figures will confirm that Perry’s contributions were not at all unusual, for example: Merck donated $4,750 to Tom McClintock, candidate for Lt. Governor of California and $5,000 to Mitch Daniels, candidate for Governor of Indiana – it’s not known what the quid pro quo was in those cases … [sarcasm].

Feel free to look up contributions made by any company (your choice) to state legislators and governors. You can use one of these followthemoney.org, OpenSecrets.org, or propublicalinks to look for yourself.

There’s also another little known fact that should make one wonder why Perry is supposed to have sold out for $6,000 in 2006.

If Perry was “for sale,” it begs the question: why did he ignore the $10,000 contributed to him in 2006 by GlaxoSmithKline (the producer of Cervarix, a competitor to Gardasil). Yes, GSK gave $10,000 to Perry’s campaign in 2006 – $4,000 more than Merck – they were the “high bidder.”

5. Is Gardasil really dangerous?

Some critics have claimed that Gardasil has a record of “very serious safety issues.” This is an obvious attempt to tarnish Perry’s image by suggesting that Perry not only did the bidding of Merck in ordering the vaccinations, he did so without considering the possible serious side effects on Texas school girls.

The CDC has been following Gardasil since its licensing and some current facts follow. The following excerpts are taken from the Centers for Disease Control and Prevention (CDC) website:

Since licensure, CDC and FDA have been closely monitoring the safety of HPV vaccines. “As of June 22, 2011, approximately 35 million doses of Gardasil® have been distributed in the U.S. and the safety monitoring system (VAERS) received a total of 18,727 reports of adverse events following Gardasil® vaccination. As with all VAERS reports, serious events may or may not have been caused by the vaccine.”

“Of the total  number of VAERS reports following Gardasil®, 92%  were considered to be non-serious, and 8% were considered serious. Out of 35,000,000 doses distributed, there were 1,498 occasions of serious complications; that equates to a .0000428 chance that a dose will cause a serious adverse reaction.” Hardly enough to consider the vaccine “a very serious safety issue” as claimed by some critics.

As of June, 2011, the CDC says: “Based on all of the information we have today, CDC recommends HPV vaccination for the prevention of most types of cervical cancer. As with all approved vaccines, CDC and FDA will continue to closely monitor the safety of HPV vaccines.”

Check out the CDC’s statements about Gardasil  for yourself. And specifically check out the Summary at the end for the CDC’s conclusion about Gardasil’s effectiveness.

Nevertheless, even in the face of no lesser authority than the CDC, some of Perry’s detractors can’t accept the truth and continue to characterize Gardasil as dangerous.

Here is a link to a .pdf of the minutes for the ACIP June 2006 meeting where efficacy studies and safety surveillance are analyzed and discussed. This is a large file (79 pages), but only the first quarter (about 21 pages) relate to Gardasil and HPV. Check out all of the facts about Gardasil if you’re so inclined. See pages 3 through 9 for the safety discussion.

Michelle Bachmann said on NBC’s “Today” show recently, it “could potentially be a very dangerous drug,” and “It can have very dangerous side effects.” All said to expand the negative aura of Gardasil and by implication, Perry. She also said a woman came up to her after the Tampa Republican presidential debate to report that her daughter had suffered from “mental retardation” after receiving the HPV vaccine.

Following is a statement from the American Academy of Pediatrics in response to Bachmann’s accusations. See a .pdf of the American Academy of Pediatrics news release here.

“The American Academy of Pediatrics would like to correct false statements made in the Republican presidential campaign that HPV vaccine is dangerous and can cause mental retardation. There is absolutely no scientific validity to this statement. Since the vaccine has been introduced, more than 35 million doses have been administered, and it has an excellent safety record.”

“The American Academy of Pediatrics, the Centers for Disease Control and Prevention, and the American Academy of Family Physicians all recommend that girls receive HPV vaccine around age 11 or 12. That’s because this is the age at which the vaccine produces the best immune response in the body, and because it’s important to protect girls well before the onset of sexual activity. In the U.S., about 6 million people, including teens, become infected with HPV each year, and 4,000 women die from cervical cancer. This is a life-saving vaccine that can protect girls from cervical cancer.”

Mainstream medical organizations, including the academy and the American Cancer Society, recommend routine vaccinations for girls, “particularly those age 9 to 11,” said Debbie Saslow, director of breast and gynecologic cancer for the American Cancer Society.

And here’s another reliable source on the “dangers” of (Gardasil) from The Mayo Clinic’s cervical cancer vaccine report:

Does the cervical cancer vaccine carry any health risks or side effects?

Overall, the effects are usually mild. The most common side effects of both HPV vaccines include soreness at the injection site (the upper arm), headaches, low-grade fever or flu-like symptoms. Sometimes dizziness or fainting occurs after the injection, especially in adolescents. Remaining seated for 15 minutes after the injection can reduce the risk of fainting. In addition, Cervarix may also cause nausea, vomiting, diarrhea or abdominal pain.

Serious side effects — including a severe allergic response (anaphylaxis), and neurological conditions, such as paralysis, weakness and brain swelling — have been reported in a small number of women. The FDA continues to monitor all such reports. To date, however, almost all reports of such adverse side effects appear to have occurred by chance around the time of immunization. They don’t appear to have been caused by the vaccine itself.

In conclusion, widespread vaccination has the potential to reduce cervical cancer deaths around the world by as much as two-thirds if all women were to get the vaccine and if protection turns out to be long-term. In addition, the vaccines can reduce the need for medical care, biopsies, and invasive procedures associated with follow-up from abnormal Pap tests, thus helping to reduce health care costs and anxieties related to abnormal Pap tests and follow-up procedures.

Any reasonable observer must conclude that the evidence shows that Gardasil is not dangerous and is, in fact, recommended by the CDC, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American Cancer Society. That should put the “dangerous” meme to rest.

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