We Can’t Fund SCHIP, But We Can Save Merck

Today, Bloomberg trumpeted the good news:  “Merck Profit Gains on Cancer Vaccine, Diabetes Pill.”

“Merck & Co., the third-largest U.S. drugmaker, reported a 63 percent gain in earnings,” Bloomberg reported, a victory made doubly by the fact that Merck has seen some rough times. “Competition from generics and the withdrawal of the pain pill Vioxx in 2004 over heart risks have pulled net income down 39 percent since 2001,” the story explained. Indeed, Vioxx gave Merck a black eye, and it’s still battling lawsuits in the courts. But Gardasil, Merck’s new vaccine to prevent cervical cancer, is turning out to be just the blockbuster the company needed. “Gardasil, introduced a year ago [already] has sales of $418 million”

Those of you familiar with my views on Gardasil may want to skip the below section, as it is pulled from an August post. I promise I won’t do this often, but this is an important subject and it’s example of how, if drug manufacturers and their lobbyists work quickly enough, they can sell their story to politicians and to the public before skeptics in the scientific community have a chance to weigh in. Remember the drug industry saying: “It’s important to sell a new drug while it’s still effective” (i.e. before people know too much about it).

On August 27, I wrote:

Earlier this month the FDA announced that the direct-to-consumer ads Merck has been using peddle its new cervical cancer vaccine, Gardasil, are “half-true . . .information currently being advertised could mislead the public.” 

But “don’t get too excited that the U.S. Food & Drug Administration
has regained its sanity,” says blogger Bill Sardi. “This is the FDA in
Thailand,” he explained. (Sardi picked up the news in the Bangkok Post)

In his August 6 announcement, FDA secretary-general Siriwat
Thiptharadol stressed what consumers need to know about Merck’s
vaccine: Gardasil can effectively protect against only two strains of
the human papilloma virus ( HPV types 16 and 18,)  which are
responsible for 70% of cervical cancers.  . . the product is not
effective against several other types of viruses which are responsible
for the remaining 30% of cervical cancer cases.” [my emphasis]

Unfortunately, Merck’s ads don’t make this point quite as clearly. In
one two-page print spread that ran in a U.S. magazine earlier this
year, the reader is told: “Now you can help protect against diseases
caused by HPV types 6, 11, 16 and 18:
    –Cervical Cancer
    –Cervical Dysplasia
   –Genital Warts.

What the reader is not told is that only two of these viruses (16 and
18) are associated with cervical cancer and they are linked to only 70%
of all cases, leaving vaccinated women vulnerable to the viruses
associated with the other 30% of cervical cancers. (The other two
viruses mentioned in the ad, types 6 and 11, cause  90% of genital
warts—an extremely unpleasant condition, but not life-threatening.) The
ad does acknowledge that “Vaccination with Gardasil may not result in
protection in all vaccine recipients” and notes that “Gardasil does not
substitute for routine cervical cancer screening.” But it doesn’t
explain why. Nowhere do the words “70 percent” or “30 percent” appear.

A more recent back-to-school ad (“ask your daughter’s doctor about
getting her vaccinated with Gardasil at her back-to-school check-up”)
does acknowledge that Gardasil will “help guard your daughter from 4
types of human papillomavirus [that] cause 70% of cervical cancer cases
. . .”  But this change comes after more than a full year of beating
the drum for Gardasil in a way that suggests that it offers full
protection. And even here, the first line of the ad exaggerates the
importance of Merck’s new product: “Gardasil is the only vaccine that
may help guard your daughter. . .”

While it’s true that Gardasil is the only vaccine that will protect
your daughter against the virus, it is not the only tool that your
doctor has at his or her disposal to insure your daughter does not die
of cervical cancer. Nor is it the best.   

                                         “Pap smears”       
The truth is that regular Pap smears provide much fuller protection
than the vaccine. In fact, in the U.S., thanks to widespread screening
with Pap smears, this slow-growing cancer has become what the National
Institute of Health classifies as a “rare disease.”  Cervical cancer
now accounts for less than one percent (.65%) of cancer deaths. This is
why Gardasil will not save millions of lives in countries such as the
U.S., Canada or the U.K. where Pap smears are readily available. There
are not millions of lives to be saved.   
This is not to minimize the fact that cervical cancer will kill 3,700
American women this year. Each one of those deaths is a tragic,
avoidable death. But almost all of the women who die will be patients
who did not receive regular Pap smears. If the aim is to save lives,
mandating vaccinations—which some states have already done—is not the
most cost-effective way to achieve that goal.

Rather than spending millions each year to vaccinate young girls
against less than ¾ of the viruses that are associated with cervical
cancer, we might invest much less in a media blitz reminding young
women to go for regular gynecological  exams that would detect
virtually all cases of the cancer.  Such a blitz, combined with a
campaign to make free or low-cost Pap smears to poor women who now
account for the majority of cervical cancer deaths in the U.S., could
save most if not all of those 3,700 lives.
In the developing world, by contrast, millions of women don’t have
access to regular Pap smears. There, cervical cancer remains a scourge.
But who in these countries can afford a $360 vaccine? And Merck has not
yet made its vaccine available at a significant discount “We’re
concentrating on high-income countries,” a Merck spokesperson told me
last summer.  After all, the company has a jump on a world-wide market
that is estimated to be worth several billion dollars a year. It is not
about to take its eye off the prize—it will need those revenues to
battle lawsuits over Vioxx, the pain-killer that it was forced to
withdraw from the market.

Meanwhile Merck’s television ads send confusing and contradictory
signals.  One familiar spot  features quick images of  vibrant, healthy
young girls who chant the company’s message: "I want to be one less
woman who will battle cervical cancer . . . One less family turned
upside down.” The ad does note that “Gardasil does not prevent all
types of cervical cancer so it’s important to continue with regular
cervical screening.” And at one point “70 percent” is mentioned.  But
the dominant message drowns out everything else: "O-N-E-L-E-S-S. I want
to be one less. One less."  The slogan seems to suggest that as long as
you are vaccinated, you will be spared.  You will be “one less woman
who will battle cervical cancer.”

                          Could the Hype Lead Girls to Skip Pap Smears?
The real danger is that “by over-hyping its potential Merck is creating
a dangerous misconception—that it is [now] less important to have
regular Pap screenings—the tried and true and very effective method of
early detection and treatment,”  blogger Judith Siers-Poisson’s wrote
on the Center for Media and Democracy’s “PR Watch” last month. “It
would be a tragic irony, she added, “if women’s infection and mortality
rates from the disease actually increase due to the belief that they
are completely protected against cervical cancer.”

Researchers foresaw the possibility that women might be lulled into a
false sense of complacency back in 2003. As a study published in JAMA
that year points out: “If women who are vaccinated perceive themselves
to be at low risk for developing cancer and, as a result, do not
participate in screening as recommended, gains from vaccination may be
offset.”

In the U.K., according to the Guardian, public health experts are
worried that the “push toward mass vaccination” is having just that
effect. In March, the paper quoted public health expert Angela Raffle
who compared the lobbying tactics Gardasil’s promoters were using to “a
battering ram [aimed] at the Department of Health and carpet bombing on
the periphery . . . My worry is that the commercially motivated rush to
make us panic into introducing HPV vaccine quickly will worsen our
cervical cancer screening programs.”

That said, there is no question that Gardasil represents a major
scientific breakthrough.  In the best case scenario, women will combine
vaccination with regular Pap smears and fewer will ever develop the
cancer—which means that fewer will have to undergo sometimes painful
treatments. As a bonus, the vaccine also will shield them from 90% of
the viruses that cause genital warts.
Most importantly, in time, researchers may be able to develop a vaccine
that provides lasting protection against all of the viruses associated
with cervical cancer. But that time has not yet come.

                                   Unknown Risks
All we know is that Gardasil seems to provide partial protection for up
to five years. Long-term trials have not yet been done. After five
years, booster shots may be needed.  And nothing is known about
potential side effects over the long term—though Merck does warn that
Gardasil “is not for women who are pregnant.” This raises another
question: what if a young woman does not know that she is pregnant when
she is vaccinated?   

Meanwhile, rather than working to distribute the vaccine in the
developing world, where it is desperately needed, governments in
developed nations like the U.S. and Canada are mandating vaccination
within their borders, hailing Gardasil as a magic bullet. It is only
recently that the mainstream media has begun to seriously question such
enthusiasm for a vaccine that is only partially effective. Two weeks
ago, Andre Picard wrote about “How politics pushed the HPV vaccine” in
the Globe and Mail:
“Not since the Salk vaccine was triumphantly unveiled in 1955 as the
miracle drug that would end the scourge of polio has there been as much
hoopla surrounding a vaccine as there is today about one that is being
touted for having the potential to eradicate cervical cancer.”

“Grandstanding politicians” both in the U.S. and Canada, have rallied
around the drug, he observes.  “Since polio, no vaccine has gone from
regulatory approval to mass use in government-funded programs with such
dizzying speed.” Yet, “unlike polio, where children were dying and
crippled in large numbers and immunization stopped an epidemic in its
tracks, cervical cancer develops slowly and the positive or negative
effects of a vaccine for human papillomavirus (HPV), which can cause
cancer of the cervix, will not be seen for decades.”

            Finance Minister “Short-Circuits” Scientific Discussion
When then, did the FDA fast-track Gardasil? Why the rush to bring it to
market? On Wall Street, cynics suggest that Merck desperately needed a
block-buster drug to replace revenues lost when it pulled Vioxx from
the market. (The problem with Vioxx is that, like Gardasil, it was
hyped with advertising which suggested that it was the best pill for
most, if not all, patients. In truth, it was suitable for only a small
number of patients who couldn’t tolerate other pain-killers. For the
majority of patients, the risks of taking Vioxx outweigh the benefits.)

Picard points out that in Canada “Finance Minister Jim Flaherty
short-circuited the scientific and economic discussions [last March] by
announcing $300-million to kick-start an HPV vaccination program.
Ottawa’s move stunned public health officials.” Picard quotes Noni
MacDonald, an infectious disease specialist and professor of pediatrics
at Dalhousie University in Halifax: “Why are politicians making medical
decisions? This is not how health-care delivery should be decided.”
MacDonald declared.

Picard also interviewed Anne Rochon Ford, co-ordinator of Women and
Health Protection. “The lack of transparency in a program that could
have a dramatic impact on women’s health is troubling,” she said, and
doubly so because governments seem to have succumbed to backroom
lobbying from the massive marketing campaign of Gardasil’s maker, Merck
Frosst Canada Ltd., and its international parent: ‘It is staggering how
quickly and secretly this has all happened and that points to some
pretty active footwork behind the scenes,’ she said.”

According to Picard, Rochon Ford added that the “rhetoric about a
vaccine with no long-term track record has been unbelievable, and the
media has mindlessly and uncritically parroted outrageous claims, while
ignoring the importance of proved measures of reducing cervical cancer
like Pap testing.”

In the U.S., a recent editorial in The New England Journal of Medicine
counsels prudence. The authors describes Gardasil’s effectiveness as
“modest”– and they conclude by suggesting that “a cautious approach
may be warranted in light of important unanswered questions about
overall vaccine effectiveness, duration of protection, and adverse
effects that may emerge over time.”

Finally, back in Thailand the secretary-general of the FDA also wants
to go slow: “There are still questions about risk” the Bangkok Post
explained, which is why in Thailand,  “advertisements for the product
in the mass media are prohibited  . . . because the vaccine is still
undergoing a monitoring process for side-effects for a period of two
years.”

But in the U.S. we haven’t gone slow. As today’s Bloomberg piece
pointed out, U.S. politician’s jumped on the Gardasil band-wagon. Who
wouldn’t want to be part of a movement that rescues young girls from
the threat of Cancer? (So what if it’s not really a threat, but a rare
disease.)


It should come as no surprise, then, that as Bloomberg reported today,
“The vaccine is now approved for funding through the U.S. Vaccines for
Children program in all 50 states. About 40 percent of U.S. children
get their vaccines through the program, according to the Centers for
Disease Control and Prevention, a U.S. agency.”  A number of states
also have committed large sums from state coffers to make sure every
girl who wants the vaccine gets it.

We couldn’t afford to fund SCHIP, but we can afford to bail out Merck.

10 thoughts on “We Can’t Fund SCHIP, But We Can Save Merck

  1. “We couldn’t afford to fund SCHIP, but …”
    Maggie, this is disingenuous. You know perfectly well that both sides in the SCHIP debate are proposing increases, and that a compromise bill will eventually be hammered out before funding stops.

  2. Yeah, maybe she should have said “We couldn’t afford to fund SCHIP, but … we can afford the $780 billion giveaway to the pharmaceutical industry under the Medicare Part D program,”
    Either way, kids don’t give campaign contributions (except when their parents max out).

  3. Unfortunately this but one small glimpse into the effect of a for profit market economy that has propelled the pharmaceutical industry to one of the top 3 most profitable industries in the world!! Maybe we should drill for cures in the artic wildlife reserve.

  4. Jack & Dr. Matt-
    You are both absolutely
    right. The drug industry
    doesn’t need the government’s largesse–they’re dong fine on their own.
    And Medicare part D was a tremendous giveaway to the drug industry.
    As for Merck, it’s problems (as a result of Vioxx) were self-inflicted by its marketing department which insisted on casting a wide net and pretending that Vioxx was the best drug for everyone.

  5. Jack & Dr. Matt-
    You are both absolutely
    right. The drug industry
    doesn’t need the government’s largesse–they’re dong fine on their own.
    And Medicare part D was a tremendous giveaway to the drug industry.
    As for Merck, it’s problems (as a result of Vioxx) were self-inflicted by its marketing department which insisted on casting a wide net and pretending that Vioxx was the best drug for everyone.

  6. Nothing like a few state mandates to make a new vaccine hugely profitable.
    Let’s just hope they’re not using mercury-based preservatives in the vaccine.

  7. Jeff–
    Yes, the state mandates have give Merck a lock on the market. And this really isn’t a decision state legislators should be making.
    If state health departments were making the call, I would feel better. But if course they could easily be pressured by politicians.
    We really need government agencies that are insulated from political pressures making public health decisions.

  8. Jeff–
    Yes, the state mandates have give Merck a lock on the market. And this really isn’t a decision state legislators should be making.
    If state health departments were making the call, I would feel better. But if course they could easily be pressured by politicians.
    We really need government agencies that are insulated from political pressures making public health decisions.

  9. Unfortunately this but one small glimpse into the effect of a for profit market economy that has propelled the pharmaceutical industry to one of the top 3 most profitable industries in the world!! Maybe we should drill for cures in the artic wildlife reserve.