THE COMING STORM OVER A CANCER VACCINE
Christian conservatives fear that new, amazingly effective cervical-cancer
vaccines will spur promiscuity and undermine abstinence. Let the lobbying
wars begin.

By JANET GUYON
October 31, 2005
(FORTUNE Magazine) - Eliav Barr has popped the champagne. After a decade of
development, his team at Merck has just finished presenting the
clinical-trial results on the company's cervical cancer vaccine, Gardasil,
to an enthusiastic audience of doctors in San Francisco. It's a medical
milestone--the first cancer vaccine ever. The results show an unprecedented
100% efficacy in fighting the dominant strains of the virus that causes
cervical cancer, a scourge that is the second-biggest cancer killer of women
worldwide. The story is on every TV network and on the front pages of
newspapers nationwide. If Merck gets Gardasil to market in the U.S. next
year as planned, not only might it become a blockbuster--with a rival
vaccine from GlaxoSmithKline, it is projected to spawn an $8-billion-a-year
global market by 2010--it could also help lift the stigma that's haunted
Merck since the debacle of Vioxx. Says Barr, the head of clinical
development for the vaccine: "This is it. This is the Holy Grail."
Some 3,000 miles away in Washington, D.C., however, a man named Tony Perkins
doesn't see it that way. Perkins is president of the Family Research
Council, a Christian organization that describes itself as a champion of
"marriage and family as the foundation of civilization, the seedbed of
virtue." He is so critical of cervical cancer vaccines that he has no
intention of inoculating his 13-year-old daughter, who the drug companies
say would be a prime candidate. The reason: The human papilloma virus, or
HPV, which causes cervical cancer, is in most cases transmitted through
sexual intercourse. If his daughter were to get the shots, Perkins believes
she would be more inclined to have sex outside marriage. "It sends the wrong
message," says Perkins. "Our concern is that this vaccine will be marketed
to a segment of the population that should be getting a message about
abstinence."
It's too soon to tell how strong a stand the Christian right will take. It
could simply counsel believers to avoid vaccination. Or it could actively
try to prevent mass inoculation--blocking its acceptance by doctors and
insurers and its funding by state and federal entitlement programs. Some
cancer survivors have trouble understanding how there could be any debate.
Diane Kae was diagnosed with cervical cancer two years ago in Philadelphia.
She still has hearing loss and digestive troubles from the chemotherapy and
radiation she went through to defeat her illness. It all could have been
avoided if the vaccines had been available when she was young. "If someone
else's life doesn't have to be changed the way mine has, that would be a
blessing," says Kae, 54, who has been married and divorced twice. "No matter
how chaste your daughters are, there is still a risk of them getting the
disease. Why would you want them to go through that?"
Although the Merck and Glaxo vaccines are still a year from the market,
already they are at the center of a brewing storm over cost, social class,
family values, and women's health. Analysts argue over whether they will be
cost effective, given that the U.S. already has a $6 billion program of
screening and treatment based on Pap smears, the cancer test that most women
in developed countries undergo regularly and that the vaccines would not
replace. Conservatives view the vaccines as morally corrosive. And the drug
companies see them as much needed new sources of profit and prestige.
Given the high efficacy and safety shown in Merck and Glaxo trials thus far,
it seems almost certain that the FDA will approve the vaccines next year.
But their fate from that point--whether they will become widely available in
the U.S., whether they will succeed commercially at all--depends not on the
market, as you might expect. Instead it rests with a little-known but hugely
powerful government group known as the Advisory Committee on Immunization
Practices, or ACIP. Attached to the Centers for Disease Control, the ACIP
makes up the national list of recommended immunizations--setting the
standard for doctors, insurers, and public funding of vaccinations. Its
mandate is to weigh medical need, cost effectiveness, and public attitudes
in arriving at a decision about a vaccine. The Bush administration has
already appointed one ACIP member from the ranks of the Christian right. So
in the case of cervical cancer, the committee is the stage on which a modern
drama of health and morality will ultimately play out.
No one disputes the need for a cure. Cervical cancer kills 270,000 women a
year worldwide, 80% of them in developing countries, with 30% in India
alone. In the U.S. this year, the CDC estimates that 3,710 will die of the
disease, most of them black, Hispanic, or poor. About 10,000 women will get
cervical cancer and recover after difficult treatment like Kae's. If the
vaccines are widely administered, especially to girls before they become
sexually active (the median age for first-time sex in the U.S. is 15),
chances are that cervical cancer could be reduced to a relatively minor
threat. And if the vaccines succeed in the U.S., the profits they generate
will likely help the drug companies make them available faster in the
developing world. It all comes down to what the ACIP decides.
When Merck and Glaxo began working on cancer vaccines a decade ago, they
never thought that something so revolutionary would come to fruition so
soon. A German virologist named Harald zur Hausen first linked HPV with
cervical cancer in 1975. His theories were discounted for years, until new
research tools enabled better detection of viral DNA. By the early '90s,
clinicians began to accept that HPV was the sole cause of cervical cancer.
If a woman had HPV and abnormalities on Pap smears, she was aggressively
treated, sometimes with procedures that hurt her ability to bear children.
Researchers later understood that only a few strains of HPV actually cause
cancer--of more than 100 viral types, just seven account for 90% of the
cancers. Others cause only warts or do nothing. Yet all are highly
contagious--transmitted by skin-to-skin contact, not just intercourse--so
condoms aren't effective. "You can just have genital touching using a finger
or toys or whatever," says Eliav Barr at Merck.
Because HPV is so easily transmitted, researchers believe that 80% of all
sexually active people in the U.S. will carry the virus at some point in
their lives, with 20 million women and men affected at any one time. Unlike
many other viruses, HPV doesn't enter the bloodstream, so it doesn't provoke
a strong immune response. Nonetheless, the body defeats most HPV infections
as effectively as it does ordinary colds; only a small percentage of women
develop the persistent infections necessary to cause cancer. To protect a
population as a virus circulates, public health experts generally want to
vaccinate anyone who is likely to be exposed.
Both the Merck and Glaxo vaccines are based on the protein shell of the
virus. So far, clinical studies have shown that when women are injected with
an empty shell, they develop a high level of antibodies that prevent the
virus from ever taking hold. Both companies' vaccines protect against the
two most common cancer-related strains, HPV 16 and 18, which cause more than
two-thirds of the cancer cases. But Merck has thrown in two more variants
that cause genital warts, HPV 6 and 11, in hopes of doubling its potential
market by enticing men to get inoculated too. The companies now are engaged
in the large, Phase 3 studies that directly precede seeking FDA approval.
Merck says it will file with the FDA in the fourth quarter of this
year--Glaxo says it will be a few months behind.
Meanwhile, the ACIP drama has already begun. As FORTUNE went to press, Barr
was scheduled to present his team's stunning results at a late-October ACIP
meeting, one of only three public meetings the committee holds each year. A
working group has been gathering research on HPV in the population, but "we
certainly don't have a recommendation yet" on the vaccines, says Janet
Gilsdorf, a University of Michigan physician who is the subcommittee chief.
Merck is hoping that the ACIP will be so impressed that it will begin to
view mass inoculation favorably--just as this June, the committee
recommended that 11- and 12-year-olds get a newly licensed tetanus,
diphtheria, and whooping cough vaccine in place of the old
tetanus-diphtheria shots. Ages 11 and 12 are also the natural time to
administer the HPV vaccine, says Merck, before children are likely to have
had sex and when they routinely get assessed for catch-up shots for chicken
pox, measles, mumps, and other diseases.
ACIP approval isn't binding, but most states look to its recommendations to
mandate what vaccines children must get before entering school. The
committee votes separately on whether to recommend federal funding, and its
support also virtually guarantees state funding, insurance reimbursement,
and--crucially--coverage of the manufacturers under a federally funded
liability-insurance program if a vaccine turns out to have deadly side
effects. "What the committee comes out with is what the doctors will rely
on," says John Salamone, head of the National Italian American Foundation,
who until June 30 served as the consumer representative on the ACIP. "That
means the government will also buy the vaccine. You notice you never see a
vaccine advertised? That's because they don't have to. It is a great
business."
But if the ACIP doesn't give its blessing, a vaccine can fail. In 1999,
Smith-Kline, now part of Glaxo, didn't get a full ACIP recommendation for a
Lyme disease inoculation, partly because its medical efficacy was
questionable. "So the uptake of the vaccine wasn't very good," says Larry
Pickering, the ACIP's executive secretary in Atlanta. After attempting to
market it directly to patients and doctors, the company pulled the product.
The ACIP's deliberations on the dual cervical cancer vaccines promise to be
contentious. The committee has 15 appointees, all public-health doctors and
academics except for the single consumer representative. To help ensure that
conservative views are articulated, one of the Bush appointees is Reginald
Finger, a public-health doctor named to the ACIP in 2003. Until September he
was also the medical-issues analyst at Focus on the Family, the influential
Colorado Springs, Colo., Christian advocacy group run by Dr. James Dobson.
Merck expects Finger to be the point man for family-values advocates. So it
has been lobbying him hard, says Finger, in hopes of heading off a
controversy over teen sex that could torpedo Gardasil. Finger says he had
many meetings at Focus with Merck representatives. "We have a cordial
relationship, but I've made no deal" with Merck, he says. He adds that he's
leaning toward putting the HPV vaccines on the national list, but not
necessarily voting for federal funding or pushing the states to require
them. That would fall short of what Merck wants. "I have a lot of different
feelings about the vaccine," Finger says. "The objective is to prevent as
much cervical cancer as possible without crossing bioethical or moral
lines." (The company confirms that it is talking to Finger, but says it
talks to a lot of experts about Gardasil and won't discuss details.)
A Focus spokesperson says the group hasn't taken a position on the vaccines
yet; it will convene a meeting to discuss the subject in early November. A
priority, according to Finger, will be for Focus to align itself with the
three other groups that have medical expertise and preach abstinence--the
Medical Institute for Human Sexuality, the Christian Medical & Dental
Associations, and the Physicians Consortium. Focus also will consult with
Perkins's Family Research Council, which split off from Focus in 1992. The
FRC predicts a grassroots uproar among Bush's "value voters" if the ACIP
recommends mass inoculation for preteens. "The vaccine is associated with
sexual activity," says Pia de Solenni, who heads women's issues at the FRC,
"and the family groups want families making that decision." She wouldn't
vaccinate her own daughter, if she had one, she says.
"This isn't as much about morality as it is about good medicine," says Hal
Wallis, a Dallas ob/gyn who heads the Physicians Consortium. "If you don't
want to suffer these diseases, you need to abstain, and when you find a
partner, stick with that partner." Gary Rose, CEO of the Medical Institute,
says his group won't take a position until after it convenes its own panel
of experts on Nov. 2. But the Institute has always maintained that
abstinence before marriage and fidelity within marriage is the best recipe
for good sexual health. How much Finger and his allies will influence the
ACIP's decision isn't clear. But at the very least, other committee members
are likely to take into account the family-values viewpoint. "These other
voices I am sure we will hear, and we will listen to them," says Gilsdorf.
With Merck lobbying the abstinence groups, Glaxo has been pushing cost
effectiveness. "The economic advantages of this vaccine are very easy to
demonstrate," says CEO J.P. Garnier. The company argues that because the
vaccines will cut the number of abnormal Pap smears and consequent follow-up
treatment, the U.S. could cut its $6 billion annual screening and treatment
costs by some 40%, or $2.4 billion. That saving more than pays for the $1
billion or so a year Glaxo and Merck hope to charge for the vaccines
(Garnier says a course of treatment, which consists of three shots, will
cost between $150 and $450). Still, the vaccines won't eliminate Pap smears.
Because they protect only against the most common strains of HPV, women will
still need to be tested for infection with others.
The ACIP has twice scheduled, then postponed, a discussion on cost
effectiveness, which now probably won't occur until February. Herschel
Lawson, an epidemiologist in the division of cancer prevention and control
at the CDC, says the issue will be enormously tricky: "A lot depends on the
data available and the many assumptions that need to be made to assess
various health states and outcomes." The ACIP also will take into account
indirect benefits, such as reduced anxiety from false positives on Pap
tests. "A vaccine doesn't have to save money to be worth recommending," says
Lauri Markowitz, a CDC epidemiologist who is the principal staff member
advising the ACIP on the vaccines.
With all this doubt swirling, the ACIP could well straddle the fence. That's
what happened after the FDA first licensed the vaccine for hepatitis B,
another sexually transmitted disease, in 1982. The ACIP recommended it only
for high-risk groups such as intravenous drug users, gays, and health-care
workers--a strategy that didn't make a dent in disease statistics. Finally,
in 1991, the ACIP changed its mind and advised doctors to inoculate newborns
as well. Only then did the national incidence of hepatitis B infections
begin to decline.
Neither the drug companies nor liberal groups such as Planned Parenthood
want the ACIP to get timid about HPV. "The conservatives are going to turn
this into a larger issue than it needs to be," says Vanessa Cullins, vice
president for medical affairs at Planned Parenthood. It hopes federal
funding will be available so it can administer the vaccine at its 850
health-care sites. "This isn't about morality, it is about public health,"
adds Cullins. Glaxo's CEO is even more blunt: "Getting the vaccine is an IQ
test. You should get it. It's that simple."
If the drug companies are to pull off their medical miracle, though, they
know they will have to win over conservatives one at a time. In July,
FORTUNE went on the road with David Hager, a Lexington, Ky., ob/gyn who
gives talks on HPV on behalf of the abstinence-preaching Medical Institute.
Lately Merck has enlisted him as an advisor in exchange for picking up some
of his travel expenses. "I've come under criticism for supporting the HPV
vaccines," says Hager. "Some conservative groups are trying to sabotage
them." The day before he was scheduled to give an HPV talk organized by the
National Abstinence Clearinghouse, Leslie Unruh, the group's leader,
threatened to cancel it. "I personally object to vaccinating children
against a disease that is 100% preventable with proper sexual behavior," she
says. Nonetheless, she decided to leave the schedule intact.
So a few days after the Fourth of July, Hager shows up to talk HPV in front
of 70 or so abstinence educators at a "Teens and Sex" conference given by
Unruh's group in Indianapolis. The meeting is being funded by the Department
of Health and Human Resources. Eagerly awaiting his talk is Cathy St. John,
a nurse who is the education coordinator for Making Abstinence Possible, a
sex-education outfit in Cincinnati. Will giving the vaccine to a young girl
"give her more of a predilection of having the casual sex she sees on TV?"
wonders St. John, a blond, middle-aged woman in a pink twinset with matching
shoes and handbag, who deplores the lifestyle portrayed on shows such as Sex
and the City. Hager's talk makes it clear that he doesn't believe that. "I
don't think a vaccine allows people to be sexually active," he tells the
crowd. "If you knew there was a vaccine for AIDS, would you be opposed to
it?"

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