If the Goal Is to Prevent Cervical Cancer…Are School Girls The Right Age Group For The HPV Vaccine?

If A Girl Gets a Gardasil Shot, When Should She Get It?

gardasil1Merck’s HPV vaccine, Gardasil, was approved by the FDA and endorsed by the Center for Disease Control (CDC)  in June of 2006. According to the Merck marketing literature, the $360, three shot-series of Gardasil, administered over six months, protects against two HPV strains that cause nearly 70 percent of cervical cancer cases and also prevents two other strains linked to 90 percent of genital warts cases. The nationwide rollout of Gardasil  was accompanied by an award-winning marketing blitzkrieg that helped raise the profile of HPV through a large-scale communications campaign, highlighted by the “Tell Someone” TV adds shown on channels with high-teen viewer-ship. Additionally, Merck waged an extensive lobbying campaign in State-houses, Congress, city councils and regulatory agencies.  Merck & Company carpet bombed the halls of power with cash, goods, services and favors to be named later. The ‘Charm and Cash Offensive’ yielded early victories amongst Federal regulators and ‘soft target’ states.

By early 2007, Wall Street analysts predicted Gardasil would generate $2 billion to $4 billion that year even without the sought-after State mandates. The State mandates offered legal cover and protected Merck shareholders from future vaccine liability losses. Based on projected Gardasil sales, the 2006 Merck Annual Report promised shareholders excellent market share and increased dividends. Good news indeed, for shareholders battered by the losses Merck endured after it pulled Vioxx off the market in 2004 (Vioxx, an FDA-approved anti-inflammatory drug for osteoarthritis and acute pain that was used by 2 million people, was linked to increased risk of heart attack and stroke.)

Things were finally“looking’ good in the Merck neighborhood”until the public  started to question why politicians were moving so quickly to Mandate the very expensive, newly released, HPV vaccine for school girls.

Critics pointed out that this vaccine is not to prevent childhood disease like mumps, measles or chicken pox…contagious  diseases that can move through schools quickly, effecting large numbers of children. Gardasil is a vaccine for a  sexually transmitted virus, that if left undetected by regular PAP screening, could lead to cervical cancer in a woman’s later years. Gardasil ‘protects’ girls from cervical cancer, the most easily detected and treatable of all the cancers that affect women.

Once a major killer in the U.S., cervical cancer has been nearly wiped out since the creation of the Pap test, which detects precancerous lesions and early cancer, and is credited with a 74 percent drop in cervical cancer deaths since 1955.

The CDC says most cervical cancer diagnoses in the U.S. are in women who either have never had a Pap test or have not had a Pap test in the previous five years. Those inoculated with Gardasil still will have to have regular Pap tests for the disease, which is hard to detect because it does not usually cause pain.

Cervical cancer does have high mortality rates in low-income regions of U.S. and poor nations where health care coverage is not routine. Cervical cancer is the fifth most common cancer among women worldwide, according to the World Health Organization, and kills about 230,000 women a year, most in developing countries. Because of these figures, public health officials still back use of the vaccine.( Note: When Merck is making it’s pitch for the need for Gardasil, they always quote the World HPV infection rates and Cervical cancer deaths, not the cervical cancer numbers for the United States.)

“The vaccine is not nearly as effective as vaccines for mumps or measles, but it is an important step forward in public health,” said Dr. John Swartzberg, director of public health policy at the University of California at Berkeley. “The vaccine will decrease the two most common strains of HPV that cause cancer, and we’ll be left with strains that have far less potential to cause cancer. In this case, the benefits outweigh the risks.”

That sounds like a great justification for childhood inoculation
until you start thinking about everything we just don’t know yet…

As with any new drug, there are potential risks that short-term studies used for federal approval don’t detect. Dr. Clayton Young, an obstetrician-gynecologist in Texas, is concerned that Gardasil will actually strengthen cancer-causing strains of HPV.

“My concern is that we are pushing ourselves into something worse than we already have,” Dr. Young said. “Vaccinating for only two strains may lead to an increase in infection with other and possibly more aggressive strains.”

Gardasil is effective against two of 10 carcinogenic HPV strains. In the United States, those two strains dominate the current statistics, estimated to have caused 6,800 new cervical cancer cases in 2006, while the other eight strains combined affected 2,900 women.

In answer to the issue of Gardasil possibly producing  more aggressive HPV strains, Dr. Haupt, executive director of medical affairs in Merck’s vaccine division, has said, “The probability of additional cancer-causing HPV strains leading to as many cervical cancer cases as today is minute.” Despite Merck’s doubt, the company is studying the additional cancer-causing HPV types in Scandinavian countries, where national cancer registries allow drug companies to track people with the disease. “It is an important issue to us,” Dr. Haupt said. “But we think the two types of HPV that Gardasil work for are unique, and if other types become more common, they will not cause cancer at the same rate and won’t over time.”

What about Merck’s early lobbying push for State mandated Gardasil shots for school girls?

State mandated Gardasil shots for preteen girls to protect them from the viruses that causes cervical cancer, are targeting the wrong age group.

Middle-school girls inoculated with the HPV vaccine will be no older than eighteen when they pass Gardasil’s five-year window of proven effectiveness  — more than a decade before the typical cancer patient contracts the sexually transmitted human papillomavirus (HPV). Merck & Co. has repeatedly refused to respond to requests for its HPV incubation statistics, stating that it is still studying the longevity of Gardasil.

Infectious disease specialists and cancer pathologists say the incubation period for HPV becoming cancer is 10 to 15 years — meaning the average cervical cancer patient, who is 47, contracted the virus in her 30s and would not be protected by Gardasil taken as a teen.

“It is a delicate balancing act,” said Debbie Saslow, director of breast and cervical cancer control at the American Cancer Society. “If the vaccine is given at too young an age, it may wear off. Yet if it is given too late, it won’t work”

Lets Look At The Numbers

In July of 2007, the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, endorsed the Gardasil inoculation for girls 11 to 12 and Merck lobbyists persuaded  lawmakers and regulators to start the fast-track push for  mandatory HPV vaccination legislation.

Dr. Joseph Bocchini, chairman of the committee on infectious disease of the American Academy of Pediatrics, says HPV can take up to 20 years to cause cervical cancer. “It can occur more rapidly, but very commonly, it is a 20-year period before it leads to cancer,” said Dr. Bocchini, whose group has endorsed HPV vaccinations on 11- and 12-year-olds but has withheld support for its mandated use.

Even when applying a longer 20-year incubation period, requiring Gardasil for sixth-grade girls, as nearly all the current and proposed legislation does, would not prevent the overwhelming majority of cervical cancer cases in the U.S.

American Cancer Society numbers show that from 2000 to 2003, more than 70 percent of cervical cancer patients were older than 40 — still outside Gardasil’s five-year protection window if given to sixth-graders.

Merck is working on a booster shot to extend Gardasil’s five years of protection. “We are aware of some evidence of immune memory. But if a booster shot is necessary, it would likely be another dose of Gardasil,” Dr. Haupt said.

Vaccine boosters vary in longevity. A ‘hepatitis B’ booster is required every 10 years, while others can provide lifelong immunity. None of the current or proposed HPV vaccine legislation addresses the potential for booster inoculations that could fall outside the enforcement mechanism — rules that bar students from school unless they have the required shots.

According to the CDC, seventy percent of females are sexually active by age 18. “The point in vaccinating kids 9 to 12 is not to reduce number of cases found in that age group, but to vaccinate prior to beginning sexual activity,” said CDC spokesman Curtis Allen. “The benefits of the vaccine decrease as women age because they are more likely to have already been infected by one of the HPV strains.”

But based on cancer statistics, cervical cancer incubation periods, and the five-year life-span of Gardasil, state lawmakers — who have billed the inoculations as a cure to cervical cancer — would have a much greater effect on cervical cancer rates by mandating its use later. Cervical cancer rates are less than one per 100,000 women until age 20 and then begin to pick up in the late 20s and early 30s. Thus, women who likely contracted HPV in their early 20s could be protected by Gardasil taken at 17 or 18.

In April 2006,  Lancet, a British medical journal published a study that concluded the GlaxoSmithKline HPV vaccine, Cervarix, is effective for 4½ years. Cervarix is not yet licensed for use in the United States, but is in wide use throughout Europe. So the targeted age group is a problematic for the EU legislators proposing mandatory HPV vaccination polices as well.

What is the probability of a school girl in America contracting cervical cancer later in her life?

Dr. Mona Saraiya, a medical epidemiologist in the Division of Cancer Prevention and Control at the CDC, says nearly all sexually active woman are exposed to HPV.

“However, only a few will get an infection that stays and won’t go away, and only a portion of those will get a precancerous lesion. At that point, only a few will eventually develop cervical cancer,” Dr. Saraiya said.

Fewer than one-hundredth of 1 percent of the 108 million U.S. women older than 18 (0.009 percent) get cervical cancer and even fewer die from it. There were an estimated 9,700 new cervical cancer cases and 3,700 fatalities in 2006, according to the American Cancer Society.

But the fact that very few U.S. women are affected by cervical cancer, hasn’t stopped the rush by lawmakers to push mandatory HPV vaccines for school girls.

“The number one problem with the vaccine is that it has not been tested adequately on the group that is recommended to get it,” said Dr. Joseph DeSoto, a fellow in the American Institute of Chemists and a physician-scientist at the National Institutes of Health.

According to Merck’s clinical study documents on Gardasil, 20,541 women ages 16 to 26 participated in four studies. The documents show some data is available on 9-year-old girls related to immune responses to the vaccine but not whether it prevents cancer.

Because most 9-year-old girls are not sexually active, it is not possible to test the effectiveness of Gardasil against cervical cancer, Dr. Haupt said. Instead, the clinical trials measured antibody responses against HPV as a proxy for cervical cancer.

Merck conducted two clinical trials that involved 1,121 girls ages 9 to 15, according to Merck’s labeling documents for Gardasil.

“The clinical trials tested younger girls, but they only looked at immune response to the vaccine, not whether it prevented cervical cancer,” Dr. Young said. “It has not been studied long enough to know that it prevents cervical cancer.”

Will Gardasil be a Mandated Vaccine For ALL American School Girls?

Well before FDA regulators approved the HPV vaccine, Gardasil,  in mid-2006, Merck’s lobbyists had started “Education Programs” aimed at State Representatives, Governors, and special interest groups to instigate a rapid deployment plan to mandate the Gardasil vaccine  for school girls around the country. In early 2007,  reacting to a furor from some parents, advocacy groups, public health experts, and after several public relation disasters precipitated by inept politicians like Texas Governor Rick Perry, ‘ham-handed’ Executive Order mandating the Gadasil shot for every school girl in Texas, Merck said that it would stop lobbying state legislatures to require the use of its new cervical cancer vaccine. The speed with which legislatures and other Government officials moved to require use of the vaccine before school entry has galvanized critics. Some say making a vaccine mandatory would pre-empt parental choice; others contend that protection from a sexually transmitted virus would encourage promiscuity. These voices were joined by others worried about the influence of pharmaceutical companies over our “Representative” Government. Many of the legislators who have sponsored some of the state laws to make the vaccine mandatory, are members of  Women in Government. WIG is a non-profit organization that is heavily subsidized  by Merck.

Merck representatives are quoted as publicly stating the company would stop lobbying specifically for state mandates, many of which would require girls to be vaccinated before they entered sixth grade. Merck made the decision to stop lobbying legislators  after realizing that their campaign had fueled objections across the country that could undermine adoption of the vaccine.

Dr. Richard M. Haupt, executive director for medical affairs in Merck’s vaccine division, said the company had acted after hearing from public health officials and medical organizations that its campaign was counterproductive. “They believe the timing for the school requirements is not right, Dr. Haupt said, adding: ”Our goal is to prevent cervical cancer. Our goal is to reach as many females as possible. Right now, school requirements and Merck’s involvement in that are being viewed as a distraction to that goal.”

But Dr. Haupt said that Merck would continue to provide health officials and legislators with education about the vaccine and would continue to lobby for more financing for vaccines in general. Public Interest groups continue in their attempts to track the  money and staff resources Merck had expended in its efforts to require use of the cervical cancer vaccine.

Dr. Larry K. Pickering, executive secretary of the Advisory Committee on Immunization Practices, the federal panel that originally recommended the vaccine’s use, applauded Merck’s decision to stop lobbying. ”They finally are going to stop doing that, which all of us will be happy about,” he said. Dr. Pickering, who works at the Centers for Disease Control and Prevention, said that while the vaccine was useful, more data on its safety, effectiveness and cost was needed. Objections to the vaccine could undermine its use. ”I think it has been somewhat counterproductive. Anything that takes away from the process of getting vaccine into people is deleterious to the whole process.”

Merck Put A Noble Spin to Getting Caught Handing Out Cash For Legislative Favors

“Merck’s goal is to support efforts to implement policies that ensure that Gardasil is used to achieve what it was designed to do: help reduce the burden of cervical cancer — the second-leading cancer among women around the world — and other HPV-related diseases for as many people as possible, and as quickly as possible,” Merck’s Dr. Haupt said about its lobbying efforts.

If you are concerned about the possibility of legistlation concerning mandatory HPV vaccines for school girls keep your eye on your representatives.

The current Merck position on lobbying is all about “For Now”.
Merck has only been delayed, not deterred.

PG

Author: H. Sandra Chevalier-Batik

I started the Inconvenient Woman Blog in 2007, and am the product of a long line of inconvenient women. The matriarchal line is French-Canadian, Roman Catholic, with a very feisty Irish great-grandmother thrown in for sheer bloody mindedness. I am a research analyst and author who has made her living studying technical data, and developing articles, training materials, books and web content. Tracking through statistical data, and oblique cross-references to find the relevant connections that identifies a problem, or explains a path of action, is my passion. I love clearly delineating the magic questions of knowledge: Who, What, Why, When, Where and for How Much, Paid to Whom. My life lessons: listen carefully, question with boldness, and personally verify the answers. I look at America through the appreciative eyes of an immigrant, and an amateur historian; the popular and political culture is a ceaseless fascination. I have no impressive initials after my name. I’m merely an observer and a chronicler, an inconvenient woman who asks questions, and sometimes encourages others to look at things differently.