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Don't strip mine our daughters!

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Corporations have a long history of exploiting natural resources — the earth's body — to make their profits. Think global warming. Think strip mining.

The drug companies are exploiting another resource:

Women's bodies.

Drug-manufacturer Merck, for example, is capitalizing on women's susceptibility to cervical cancer.

Merck has waged a nationwide campaign to make its Gardasil vaccine mandatory for sixth-grade girls. The company has lobbied state legislators to make 11- and 12-year-old girls ineligible to attend school unless they've received the vaccine's three doses.

Why bother creating consumer demand for a drug with limited effectiveness when you can bypass the illusion of free enterprise and free choice?

Why bother creating consumer demand for a drug with limited effectiveness when you can use the government to enforce it?

The company recently suspended its campaign in response to parents' and medical groups' objections. But not before the campaign had made its mark. And not before its questionable practices had come to light.

Merck makes its mark

According to the National Conference of State Legislatures, at least 34 state legislatures are considering bills to require, fund or educate the public about Gardasil.

For state-by-state information, see www.ncsl.org/programs/health/HPVvaccine.htm#hpvlegis

In my home state, North Carolina, Senator Katie Dorsett, a member of Women In Government, and Senator Janet Cowell have sponsored Senate Bill 260. This act requires the department of health to distribute information on Gardasil through schools to all parents of children in grades 5 through 12.

      Pushing drugs

Drug pushers. We think of them as nasty, greedy characters who lurk around playgrounds and try to hook our children on buying their "product."

Do we really want the legislature and the schools we support with our taxes to become drug pushers for Merck?

      Questionable practices

How has Merck lobbied legislatures to ensure its market share among sixth-grade girls?

Merck bankrolls Women in Government, a political action group that enlists female state legislators. A senior officer in the company's vaccine division has participated in the group's business council. We can imagine what part this company representative has played in setting the group's agenda.

Merck carried out its campaign to make Gardasil mandatory through its front, Women in Government. Can we say "co-optation"?

      More questionable practices

In Texas, Governor Rick Perry bypassed the legislature entirely and went direct to issuing an executive order on February 2 making Gardasil mandatory for girls entering the sixth grade.

Is it coincidence? One of Merck's lobbyists in Texas is the governor's former chief of staff. Merck's political action committee funneled $6,000 to the governor's re-election campaign.

Texas legislators have introduced bills to override the governor's executive order.

      What's the rush?

Making Gardasil mandatory has been a rush job. Federal regulators approved the vaccine in June 2006. Within six months, bills to require the drug for sixth-grade girls were turning up in state legislatures.

Usually, vaccines earn public acceptance and official endorsement gradually, as years of experience show them to be safe and effective.

Analysts estimate the annual market for HPV vaccine to be $5 billion. Perhaps, as some suspect, Merck is anxious to establish Gardasil before its rival, GlaxoSmithKline, can bring a similar vaccine to market.

Each year, about two million American girls enter the sixth grade. Perhaps Merck wants to get its vaccine into as many of these girls as possible before another drugmaker challenges its market share.

A drug with limited usefulness...

Gardasil protects against only two of approximately 19 types of the Human Papillomavirus (HPV) that can cause cervical cancer (source: Prophylactic human papillomavirus vaccines, Journal of Clinical Investigation. 2006 May;116(5):1167-73).

We've seen how the widespread use of antibiotics has allowed for the mutation and proliferation of pathogens that are resistant to antibiotics.

Won't the use of Gardasil open the way for the other 17 types of HPV to become all the more active in causing cervical cancer?

Gardasil does not protect against the types of HPV that currently cause 30% — nearly one-third — of all cases of cervical cancer. Even if they're vaccinated with Gardasil, girls and women will still need to receive regular Pap tests to screen for and provide early detection for cervical cancer.

The American Cancer Society reports that, with early detection, cervical cancer is usually treatable.

      ...and unknown usefulness

The duration of immunity that Gardasil provides is unknown (source: Merck's Prescribing Information, page 5).

The initial vaccination may provide its limited immunity for as many as four or five years (source: Sustained efficacy up to 4.5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial, Lancet. 2006 Apr 15;367(9518):1247-55).

If girls and young women choose to receive the Gardasil vaccine, how often will they need additional injections of Gardasil to maintain the limited immunity that this vaccine does provide?

      ...and questionable safety

Each dose of the Gardasil vaccine contains "approximately 225 mcg of aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant)" (source: Merck's Prescribing Information, page 1).

Aluminum is known to be toxic to the nervous system (source: Fact Sheet: Aluminum and Alzheimer's Disease, Alzheimer's Association, June 20, 2002.)

How will Gardasil affect girls' intellects and their performance in school?

A life-saving drug — for Merck

The wholesale price of the three-dose Gardasil vaccine is $360. The cost to consumers, with added administrative and distribution costs, is $500 or more. It is the most expensive vaccine ever brought to market.

Merck's sales of Gardasil reached about $80 million well before the close of 2006. Richard Haupt, executive director for the company's media affairs, has noted the product's "extraordinary uptake," adding that the vaccine's price reflects Merck's investment in development plus its value to society in preventing disease.

We can imagine that Merck hopes to generate billions in sales. Why? To offset the company's losses.

What losses? Check out the damage done by two of Merck's other drugs, Vioxx and Fosamax.

      Vioxx

Merck's aggressive sales campaign made Vioxx, designed to relieve chronic pain and menstrual cramping, one of the most frequently prescribed drugs in history.

The company removed the drug from sale in September 2003. Vioxx generates kidney problems and doubles the risk of heart attack and stroke.

Through its own clinical trials, Merck knew about the drug's potentially serious side effects as early as 2001. Yet it failed to provide any warning. And here's a company that represents itself as a "pharmaceutical company dedicated to putting patients first."

In 2006 alone, Merck spent about $500 million on legal costs related to Vioxx. How many doses of Gardasil will Merck have to sell to remedy its bottom line?

      Fosamax

Merck introduced and began promoting Fosamax, designed to alleviate osteoporosis, in the mid-1990s. The osteoporosis target market has grown by leaps and bounds since then: the number of reported cases has increased from .5 million to 3.6 million.

The company helped the cause by engaging in a new sideline: supplying equipment to measure bone density and identify new cases of low bone mass.

In 2002, evidence began accumulating that Fosamax causes decay and death of the bone in the upper jaw. As many as 38% of customers taking Fosamax and similar drugs are suffering the decay and death of their jawbones.

Now, in 2007, the drugmaker is setting aside $48 million to defend against the damages done by Fosamax.

Who's dedicated to putting patients first?

      Footing the bill for Merck's bailout


As the Texas governor and state legislators mandate Gardasil, the most expensive vaccine in history, they also address its cost. They provide various answers the question: Who will foot the bill for Merck's bailout?

Some legislation seems to leave it to each family to buy Gardasil for their girls.

Other bills, as in Pennsylvania and New Mexico, require insurance providers to cover the cost of the vaccine.

Legislation in other states — in Connecticut and Maine, for example — favors paying Merck through state insurance plans and federal Medicaid funding.

Still other states envision paying Merck with money appropriated from the general fund. Arizona, for example, would contribute $2.6 million and Kentucky would contribute $4.12 million to the cause. Vermont's contribution rises to nearly $8 million.

      Disparities in health and health care

Some consider cervical cancer to be largely a disease of poverty, disproportionately affecting women who can't afford or don't receive regular screening for early signs of the disease.

In June 2006 the Advisory Committee on Immunization Practices of the federal Centers for Disease Control and Prevention recommended that all girls and women ages 11 to 26 receive the Gardasil vaccine. Doing so, the committee set the federal government on the path to purchase the Merck product for America's poorest girls ages 11 to 18. Gardasil, priced at $360 wholesale, is the most expensive vaccine ever developed. For approximately seven million girls, that's an expenditure of $2 billion or more.

I ask you: If cervical cancer is largely a disease of poverty, why not eliminate poverty?

I ask you: What's more empowering for a girl — being forced to receive a drug or learning to actively value herself?

I ask you: Is this corporate bailout without representation? Is anyone ready for a tea party?

      Vax, vax, vax

Of the ten vaccinations currently recommended or required for children and teens, six are manufactured by Merck. Making Gardasil mandatory increases Merck's share of the goldmine: the company then makes seven vaccines out of the eleven required or recommended.


Safety first

Vaccines are vulnerable to contamination as they're manufactured. For example, in August 2004, Chiron, the British company manufacturing flu vaccine for the United States market, discovered bacterial contamination in 10% of its doses.

Subsequently, the U.S. Food and Drug Administration's inspection found "significant deficiencies in quality control and concerns regarding the test results. Although Chiron's retesting of the unaffected lots of vaccine has been negative for contamination, FDA has determined that it cannot adequately assure the sterility of these lots to our safety standards" (source: 2004 Chiron Flu Vaccine Chronology, U.S. Food and Drug Administration).

Can Merck really guarantee the Gardasil vaccine is free from contamination?

Whom do you trust?

Okay, Merck knew about the potentially lethal side effects of Vioxx and kept them secret. Did they know about the dangers of Fosamax, too, and forget to tell anyone?

      Thalidomide

Consider another drug marketed to women: thalidomide, sold from 1957 to 1961 to pregnant women in nearly fifty countries under a variety of names, for relief from morning sickness.

Women who took thalidomide while they were pregnant gave birth to an estimated 10,000 children with devastating malformities.

The U.S. distributor, Richardson-Merrell, knew about at least some of the drug's side effects. They failed to disclose that information to the Food and Drug Administration.

Richardson-Merrell was distributing thalidomide as Kevadon on a limited "investigational" basis pending FDA approval. They told American doctors "We have firmly established the safety, dosage, and usefulness of Kevadon by both foreign and US laboratory and clinical studies." They lied. The drug, originally developed in Germany, had barely been tested at all.

      The power of "no"

In the United States thalidomide, distributed as Kevadon, caused seventeen children to be born with deformities. The drug never received FDA approval for sale because Frances Oldham Kelsey was unsatisfied with the drug's safety. She rejected the drugmaker's application to approve Kevadon six times.

Witness the power of saying "no."

      DES

Diethylstilbestrol (DES) is a synthetic estrogen. Although no studies had investigated the drug's safety or effectiveness for pregnant women, in 1947 the FDA approved the drug for pregnant women to prevent miscarriage.

Six years later, research reported that the drug had no effect at all in preventing miscarriages or premature births. Nevertheless, manufacturers continued to market DES aggressively and physicians continued to prescribe the drug.

The link between DES and the damage it causes became known in 1971 and evidence continues to accumulate.

Women who took DES while pregnant are at an increased risk for breast cancer.

Their daughters' risk of breast cancer after age 40 is more than doubled. They're also at increased risk for vaginal and cervical cancer, infertility, and complications during pregnancy.

Their grandchildren are at risk for cerebral palsy, blindness, and other neurological disorders.

History in the making

Gardasil: Made by Merck, the people who were so happy to bring you Vioxx and Fosamax.

Gardasil: Taking its place in the history of drugs marketed to women — drugs such as thalidomide and DES.

Can we say "no"?

What about men?

Boys and men can be asymptomatic carriers of HPV. They can pass along the viruses that cause cervical cancer without having any symptoms of infection themselves.

Yet the HPV viruses can have serious consequences for boys and men. They can induce penile cancer and anal cancer, particularly a concern among gay men.

HPV viruses can also cause genital warts; while not lethal, such warts can be both uncomfortable and embarrassing. Gardasil provides protection against two of the viruses that cause 90% of genital wart cases. John Schiller of the National Cancer Institute suggests that "this provides a reason other than altruism for men to be immunized."

Why isn't Gardasil a required vaccination for boys? In Australia and the European Union, regulators have already approved Gardasil for boys ages 9 to 15 based on evidence it stimulates an immune response in boys. The vaccine's effectiveness in preventing infection in sexually active men remains to be seen. The results of Merck's clinical trial of Gardasil among 4,000 men, including 500 gay men, are due toward the end of 2008.

A study of heterosexual men ages 18 to 40 in the United States and elsewhere found a 50 percent HPV infection rate among them, higher than among women the same age. At this point, however, men may not realize they may be carrying viruses that pose a high risk their partners' health.

What we need is an educational campaign for boys and men that matches Merck's savvy "One Less" campaign that promotes Gardasil to girls and women. In "Pitching Protection, to Both Mothers and Daughters," Claire Dederer provides an inside look at the drugmaker's sell.

Education

Gardasil protects against two out of the 19 types of HPV that cause cervical cancer and two of the HPV viruses that cause genital warts. It does not protect against any other type of sexually transmitted disease.

Even if a girl has been vaccinated with Gardasil, at family or taxpayer expense, does she still need to get a Pap test annually, to screen for cervical cancer and other sexually transmitted diseases?

Yes.

Even if a girl has been vaccinated with Gardasil, at family or taxpayer expense, does she still need to insist that a boy use a condom during sexual activity?

Yes. (Even condoms offer only partial protection with respect to HPV-induced cervical cancer. According to Denise Grady's article, "A Vital Discussion, Clouded," published in the New York Times on March 6, 2007: "Intercourse seems to be the best way to transmit [the HPV viruses], but any type of genital contact increases the risk, and condoms offer only partial protection because skin beyond the condom may be teeming with the virus. Much of the time, the viruses cause no problems, and people don't even know they're infected.")

Still, boys using condoms would go a long way to protecting girls against all types of HPV-induced cervical cancer and other sexually transmitted diseases.

Ensuring that boys use condoms would require some education.

Ensuring that girls are strong and self-validating enough to get themselves annual Pap tests and to insist that boys use condoms — that would require some education, too.

Investment

Frankly, I'd rather invest in our boys' sense of responsibility and our girls' strength of character than in bailing out Merck.

Strong and self-validating girls know that their bodies are not "resources" for others to exploit.

Will you say it with me? Don't strip mine our daughters!

 
For more information and continuing updates:
Associated Press
New York Times
Women In Government

 

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