have a long history of exploiting natural resources the earth's body
to make their profits. Think global warming. Think strip mining.
drug companies are exploiting another resource:
Merck, for example, is capitalizing on women's susceptibility to cervical cancer.
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.
bother creating consumer demand for a drug with limited effectiveness when you
can bypass the illusion of free enterprise and free choice?
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.
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
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.
Drug pushers. We think of them as nasty, greedy characters
who lurk around playgrounds and try to hook our children on buying their "product."
we really want the legislature and the schools we support with our taxes to become
drug pushers for Merck?
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"?
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.
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
Texas legislators have introduced bills to override
the governor's executive order.
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.
vaccines earn public acceptance and official endorsement gradually, as years of
experience show them to be safe and effective.
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.
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...
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).
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
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
The American Cancer Society reports that, with early detection,
cervical cancer is usually treatable.
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
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?
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
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.
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.
can imagine that Merck hopes to generate billions in sales. Why? To offset the
What losses? Check out the damage done by two of
Merck's other drugs, Vioxx and Fosamax.
aggressive sales campaign made Vioxx, designed to relieve chronic pain and menstrual
cramping, one of the most frequently prescribed drugs in history.
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."
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?
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.
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
Who's dedicated to putting patients first?
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
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.
other states in Connecticut and Maine, for example favors paying
Merck through state insurance plans and federal Medicaid funding.
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.
in health and health care
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.
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.
ask you: If cervical cancer is largely a disease of poverty, why not eliminate
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?
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.
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.
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).
Merck really guarantee the Gardasil vaccine is free from contamination?
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?
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
Women who took thalidomide while they were pregnant gave
birth to an estimated 10,000 children with devastating malformities.
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.
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
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.
the power of saying "no."
(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.
who took DES while pregnant are at an increased risk for breast cancer.
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
Their grandchildren are at risk for cerebral palsy,
blindness, and other neurological disorders.
History in the making
Made by Merck, the people who were so happy to bring you Vioxx and Fosamax.
Taking its place in the history of drugs marketed to women drugs such as
thalidomide and DES.
Can we say "no"?
What about men?
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.
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.
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
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.
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.
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.
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
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
that boys use condoms would require some education.
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,
Frankly, I'd rather invest in our
boys' sense of responsibility and our girls' strength of character than in bailing
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!