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PHARMA: Merck’s Miracle Vaccine –What Is This Story Really About? By Maggie Mahar

GardasilYesterday, Merck announced that it is no longer going to try to persuade states to make its new $360 cervical cancer vaccine mandatory for all pre-teens. (At least, not publicly). The company wouldn’t divulge how much it has spent, to date, on its lobbying campaign.

Virtually everyone has heard about “Gardasil.” Planned Parenthood backs it. Women in Government extols its virtues. (Both organizations receive significant contributions from Merck). Not long ago, a glowing New York Times editorial congratulated Texas governor Rick Perry for mandating “A Vaccine To  Save Women’s Lives.”( So far as I know, Merck makes no contributions to The New York Times, but Perry’s former chief of staff is a Merck lobbyist.) At this point, twenty states have drafted plans to follow Perry’s example

Last summer, I wrote about the vaccine on American Prospect Online. At the time, I tried to make two points. First, while Merck’s vaccine could cost U.S. patients, insurers and state governments billions of dollars, it will not be saving millions of lives—because, in the countries where it will be available, there are not millions of lives to be saved.

In the U.S., we already have come close to winning the war on
cervical cancer with the $30 Pap smear — a simple test that has proven
remarkably effective. Thanks to screening, between 1955 and 1992 the
number of cervical cancer deaths plunged by 74 percent, and the numbers
are still shrinking. From 1997 to 2003, deaths fell by an average of
3.8 percent each year. In 2006, it’s estimated that cervical cancer
will account for just less than one percent (.65% to be exact) of the
anticipated 273,560 cancer deaths among American women.

That said, the numbers suggest that more than 2000 American women
could  die of the disease this year—an  unacceptable number. According
to a study published in JAMA, most will be women who rarely had Pap
smears; a disproportionate share will be poor or members of minorities.
But how many of these women are likely to get a $360 vaccine? Rather
than contributing billions to Merck’s coffers, we might better take
part of that money to launch a campaign to try make sure that every
young woman in the U.S. gets in the habit of going for regular Pap
smears.

In the emerging world, where Pap smears are not readily available,
cervical cancer remains a scourge.  But, in that world, who can afford
a $360 vaccine? Last summer, when I asked Merck whether it planned to
make the vaccine available at a discount to women in poorer countries,
I was told that the question was “premature.” For now, a company
spokesperson explained, the company is eying the “118 to 120 million
women in the 11 to 26 age range in the U.S., the EU, and other
high-income countries.” Merck still hasn’t announced a plan to make
Gardasil affordable where it is needed most.

The second point that I tried to highlight last summer is that
Merck’s miracle vaccine guards against viruses that account for just 70
percent of all cases of cervical cancer. In the media, Gardasil is
usually described as a vaccine that protects against “most” viruses
that lead to the cancer. Okay, 70% is more than 50%, so technically,
it’s “most,” but the phrase is misleading.

Girls and young women who are immunized still will be vulnerable to
the viral strains that account for 30% of all cases of cervical cancer.
This is why, as even Merck acknowledges, girls who receive the vaccine
still need regular Pap smears.

Meanwhile, a 2003 study published in JAMA points to the danger that
“women who are vaccinated [will] perceive themselves to be at low risk
for developing cancer and, as a result [will] not participate in
screening as recommended.” If they are lulled into a false sense of
complacency, the study acknowledges “gains from the vaccination may be
offset.” Last week, Bloomberg News reported that in the U.K. health
officials have similar concerns .

Less than weeks ago, a report on NBC put flesh on their fears. It
featured a young girl in Texas explaining why she is happy to have been
vaccinated: “Now this is one cancer I don’t have to worry about
fighting.” No one corrected her.

Finally, as Merrill Goozner (author of The $800 Million Pill: The
Truth Behind the Cost of New Drugs and director of the Integrity in
Science project at the Center for Science in the Public Interest) )
pointed out on Gooznews last Monday,
we don’t know much about the possible side effects of the vaccine.
Like Merck’s other famous drug, Vioxx, Gardasil  was “fast-tracked” by
the FDA. Goozner, who is the father of a 13-year-old daughter, has no
plans to have her vaccinated.

In the mainstream media, the only publication that seems to have
truly understood, from the outset, what this story is really about is
The Wall Street Journal. This is after all, a business story.  As the
Journal explained more than three weeks ago: “Mandatory vaccination
across the U.S. would make Gardasil an automatic blockbuster for Merck
at a time when the patents on some of its bestselling drugs are
expiring and it’s desperate to replace their revenue streams.”

Meanwhile, the Journal noted, “A growing number of parents are
worried about exposing their children to the unforeseen side effects of
a new vaccine to protect them from a disease that is no longer very
common in the U.S. and often doesn’t develop until much later in life.
. . . Adding to some parents’ concern, 82 adverse events among both
teens and adult women have been reported since Gardasil became
available last June. . . . Of the more than 25,000 patients who
participated in clinical trials of Gardasil, only 1,184 were preteen
girls. ‘That’s a thin base of testing upon which to make a vaccine
mandatory,’ says Barbara Loe Fisher, co-founder of the National Vaccine
Information Center, an advocacy group that lobbies for safer vaccines.
. . Merck declined to say how much money it has funneled into its
lobbying campaign, or contributed to Women in Government,” the Journal
reported..  “A spokeswoman for Women in Government, Tracy Morris,
declined to say how much it had received from Merck.” 

The campaign to vaccinate every girl and young women in the U.S. is
not about saving women’s lives. It is, as the Journal so clearly
understands, about money. It is about Merck’s desperate need to replace
the revenue that it lost when it was forced to pull Vioxx off the
market.  Some call Gardasil the “Help Merck Pay For Vioxx Vaccine.”

Finally, Merck’s campaign stands as an example of a for-profit
corporation trying to set healthcare spending priorities for the
nation. This is not Merck’s job.

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19 replies »

  1. Though the vaccine is a good thing it is also limited. It can only work for women under a certain age. According to an article released last week from the “Ovarian Cancer Prevention – 2008 Is Not Too Late” from http://www.hometowncobb.com/living/health/ovarian-cancer-prevention-2008-is-not-too-late.shtml
    the article “What about the over 70% of women who aren’t diagnosed until an advanced stage. One in 55 women in the United States will be diagnosed this year and more than 15,000 will die from the disease. Mortality rates from cervical/ovarian cancers are the highest among all gynecologic cancers.”

  2. I agree that immunization shouldn’t be mandatory for a disease caused by an (almost always) voluntary act. After all, we don’t screen for and hunt down persons with genital herpes and make them take antivirals, as we have done with TB or much more communicable diseases.
    On the other hand, Gardasil also prevents a much more common condition than cervical cancer — genital warts (effective against HPV types 6 and 11 which cause approximately 90% of genital warts). Reported cases have been steadily increasing for decades (info here), and now far outnumber reported cases of genital herpes. And reported cases likely far underestimate the real numbers, since it is often difficult for a women to detect an infection without a clinical exam. And the treatments, again especially in women, can be uncomfortable and needed repeatedly.
    So the public health impact might not be primarily to prevent cancer, which we do a pretty good job with (in women who get pap smears regularly), but to markedly reduce a condition that we don’t presently screen for or treat easily.

  3. The religious right couldn’t have given Merck’s campaign a bigger boost if they tried.
    Having spent a long time reporting on Wall Street, I suppose I’m overly cynical, but one can’t help but wonder if Merck (or one of the many organizations that it contributes to) gave the Christian right some encouragement?
    In any case, the loud protest from the religious right made the issue seem a no-brainer to many liberals. And so they never really looked into the facts about the vaccine.

  4. Weren’t pro-abstinence religious orginizations (and the congressmen they support) staunchly opposed to this vaccine being approved? I can’t currently recall their stated reasons, but it wasn’t hard to see that with more and more sex education, HPV is one of the only remaining tools in their scare tactics kit given its ability to be transferred while practicing safe sex.
    Dan Savage, in his sex and relationship advice column Savage Love, made it a special point of discussing resistance to approval of the vaccine over the course of the last two years. Even he referred to it as “100% effective” while decrying the vaccine’s opponents in the political Right. (see column here: http://www.avclub.com/content/node/46583)
    As many have pointed out above, an overconfidence in this vaccine may lead to fewer pap smears, which will in turn lead to cervical cancer deaths that could have easily and cheaply been prevented.
    This means the scare tactic is at least at least partially right, even if it was done for moral/political reasons rather than those of public health. This was not something I would have ever guessed about a year ago and goes to show the mind reeling things that can happen when healthcare and politics collide.

  5. A little history lesson: This is the same Merck that invented streptomycine to be used to treat TB. According to Fran Hawthorne’s “The Merk Druggernaut” (2003) Merck also discovered Mectizan a treatment for river blindness which infected million of poor people in the 3rd World. In 1987 as a philanthropic act Roy Vagelos Merck’s CEO donated this drug to the WHO.
    Has so much has changed in the past 20 years for current leadership of Merck to “To do the RIGHT THING” and follow Vagelos’ lead with Gardasil? Merck’s milked Mectizan for 20 years, now its time to update it’s beneficence and donate Gardasil to the millions of poor women in the 3rd World who can benefit from this miracle.
    South Carolina has fallen for the bait and is pushing the mandate girls vacination legislation. We can’t expand our SCHIP program to 200% FPL but we can mandate vaccines with a limited cost benefit. Yeah the market works at least it buys legislators.

  6. Well, as a pathologist I can add a little data to the discussion. Pap smears, while cheap, are not very accurate taken as a one-time test (think of it as a needle in a haystack problem). Also, there is a large category of women in which the pap smear is abnormal but not overt cancer; a lot of time and money is spent on additional testing and followup for these women, many of whom have no disease. So the concept of a vaccine for the most common cancer-causing strains of HPV is not a bad one.
    However, I am horrified at anyone talking about making it mandatory at this point, for the same reason that Merrill Goozner points out (nice work, Merrill) – this vaccine is so new that no one knows what short or long term side effects may arise when it is given to millions of women and girls. There are numerous drugs which looked fine in testing but only because the test sample was too small to detect statistically low-incidence side effects, then had to be withdrawn post-market.
    I have a 16 year old daughter and would resist to the death any attempts to make her have it until it’s been out there for a year or more and further studied post-market. I was even given this same advice by a friend who works at the FDA (although not in the drug approval division). It’s just plain common sense.
    bev, M.D.

  7. The reason cervical cancer is a rare disease is that pap smears every three years decrease the chances of dying from cervical cancer to the point that it is almost a reportable event. Considering how common it was to die from it as a young women around the turn of the century, its essential eradication as an undiagnosed cause of death is an astonishing public health accomplishment, equal to that of smallpox or polio. Georges Papanicolaou stands tall in the pantheon of my profession and my country. He was a first generation greek immigrant trained in his home country. There is a dirty forgotten brass plaque in the sidewalk somewhere in the Villiage in Manhatten that I saw 10 years ago identifying the grocery store where her worked early in this century before he could practice medicine . He deserves better. I try to honor his achievment by asking every woman I encounter professionally about their pap status.
    The vaccine won’t save many lives, in fact, the “bulletproof” effect on behavior may result in less compliance with paps and therefore a poorer outcome. With an intervention so breathtakingly effective as paps, it only takes a little decrease in complience to have a catastrophic effect on outcome.
    What it will do is preserve fertility. If it prevents HPV changes, even a little, it will eventually reduce the number of women who go to cervical instrumentation of some sort. Such instrumentation increases infertility and certain intrapartum risks, such as cervical incompetence.
    It is, however, a gift from God to women in the third world for whom the more effective intervention, paps, is not available. Like american women in the early 20th century, these women die from the disease in their early twenties. I sure hope the vaccine finds its way to them. Considering how sluggishly the even more effective rotovax is being introduced I am not optimistic.

  8. Funny thing is one of the major reasons that Pap smears testing is so widely common now is due in part to state mandates. While the specific mandate law varies slightly from state to state, almost every state enacted a mandate for annual Pap smear testing during the 90s.

  9. Peter–
    Yes what you write is entirely true.
    The short answer to your question: to meet Wall Street’s earning targets, Merck needs the money now–not in 20 years.
    To its credit, the WSJ makes this clear.
    And you’re also entirely right about the HPV virus. It is commonplace, and in most women it disappers without doing any harm.
    But when laying the groundwork for its vaccine (about a year before it came to market) Merck began running tv ads showing mothers and daughters talking about the HPV virus–how “millions of women” are infected, etc. They made it sound like HIV.
    They didn’t mention that in most cases the virus proves harmless–or that the Institute of Medicine now classified cervical cancer as a “rare disease” (in the U.S)
    The ads looked like public service announcements. Only a little logo at the bottom of the screen told you that these ads had been produced by Merck. And no mention was made of the fact that Merck was coming out with a product to address this virus.
    The scare tactic worked–and really set the stage for the hysteria that, in turn, led to the idea of requiring that every public shcool girl be vaccinated.

  10. Is ths valid?
    “Although HPV is very common, cervical cancer is not. The virus usually disappears on its own in a few months without causing any problems. In fact, studies show that 70 percent of new HPV infections in young women disappear within one year, and as many as 91 percent disappear within two years. However, it’s important not to be complacent. Only persistent infections – more commonly found in women 30 or older – can lead to cervical cancer if pre–cancerous cell changes caused by HPV are not detected and treated early. In fact, it is estimated that women who have HPV are more than 200 times more likely to develop cervical cancer than those who don’t have the virus.”
    If the above is valid then why are young girls being government forced to get the vaccine? Money for Merck?

  11. Will people who get the vaccine still need to undergo annual Pap smears? Will the administration of the vaccine reduce the cost of screening?

  12. No one knows what the booster might cost. But we can be sure that Merck will charge whatever the market will bear And if some states actually mandate the vaccine, then they’ll be on the hook for the booster . ..

  13. “It is, as the Journal so clearly understands, about money.”
    That’s ok though. It is a great breakthrough and hopefully it will save some lives, but it’s more likely to just prevent vaginal warts. I don’t have a problem with Merck making money off a great drug. Shamelessly exploiting this as some miracle cancer cure is a problem. Also, I’ve been told (but have not verified) that the vaccine has been tested abroad in larger numbers.

  14. Thanks for this, Maggie Mahar. I am sick of these “wonder-drugs” getting fast-tracked to the public with inadequate testing, and then flooding the airwaves with misleading advertisements. Drugs are only one aspect, but this is exactly why “consumer-driven healthcare” is a bogus business-created slogan–how is the consumer supposed to make a smart decision when all of the information she is being given is not coming from objective sources, but is instead coming from a company that just wants to profit from unfound paranoia? And when even the “objective sources”, including the FDA, are in the pocket of those companies? I am also very disappointed to hear that Planned Parenthood has come out in favor of this nonsense.

  15. My understanding is that the vaccine only provides protection for about 4-5 years, after which a booster would be required at additional cost. Since this is a disease that can only be spread by sexual contact (as opposed to coughing or spreading germs), there is no way it should be mandatory. People who want it can get it. Leave it up to the family and the individual.

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