March 7th, 2007
In early January Marilyn
Canavan and Andrea Boland, two legislators from wintry Maine, traveled to
the tourist resort of Marco Island, Florida, for a conference organized by
Women in Government (WIG), a non-profit organization.
The annual, bi-partisan event for elected women in state governments around
the U.S. had a number of issues on its agenda from higher education to the
state of women in politics.
One focus, preventing cervical cancer, included information on Gardasil a
new vaccine manufactured by pharmaceutical giant Merck, that protects
against the two human papilloma virus (HPV) strains that cause 70 percent of
cervical cancers.
"The tenor of presentations they were not discussions seemed
one-sided to me," said Canavan, a four-term legislator. "I remember
thinking as I was leaving the meeting, 'I just don't want to do this ... we
need to have public dialogue.'"
Boland also reported "a pull to get on board [promoting vaccination]... and
when I raised questions, the response was 'Do you want your daughter to die
of cancer?'"
Boland, a first-time legislator, joined Canavan, a WIG state director, at a
small planning session, where she was taken aback by the extent to which
corporations influenced WIG. "When discussing what the agenda for next year
would be," participants were told to 'wait to see who's funding things.'"
Similarly before fixing the program for next year, they "had to see what the
sponsors want," said Boland.
Boland's suspicions were further raised by a casual conversation one evening
over a glass of wine with one of the conference speakers, Boston pop singer
Christine Baze. "She was a young attractive woman with a beautiful voice and
a moving tale of surviving cervical cancer," said Canavan. Baze mentioned
that a pharmaceutical company had paid for her appearance.
Both legislators believed that preventing cervical cancer was a worthy
project, but it wasn't until a month later that Canavan and Boland learned
that, more than making the vaccine available, Merck and WIG were campaigning
to make Gardasil mandatory for all 11-12 year old girls.
Then, after the governor of
Texas, Rick Perry, passed an executive order mandating vaccination for all
girls entering sixth grade, Canavan learned something that shocked the
former director of the State Ethics Commission: She discovered that WIG had
taken funding from Merck.
On March 2nd, Canavan resigned from WIG. "An organization that stands to
profit, like a pharmaceutical company, shouldn't be driving the health
agenda in public realm," said Canavan. "You see so many front organizations,
I'm not going to say Women in Government is one, but it matters who's
funding them. My early training emphasized doing the right thing and being
guided by conscience."
What Boland and Canavan had come to realize was that the Florida conference
presentations had been part of a state-by-state lobbying campaign
spearheaded by WIG to support Merck's efforts to make Gardasil mandatory.
WIG members were well placed to promote bills in state legislatures or help
convince governors to promote that agenda. But revelations of money trails
and the rush to make a new vaccine mandatory created a backlash and forced
Merck, on February 20th, to publicly abort its lobbying campaign for
mandatory vaccination of school girls.
Launching the Vaccine
Cervical cancer affects 10,000 women in the United States every year, and
kills 3,700. The toll is far greater in the developing world, where most
women lack the diagnostic Pap tests that catch signs of cancer when it is
still treatable.
New Jersey-based Merck, one of the world's largest pharmaceutical companies
had been hoping to reap billions of dollars from Gardasil. Most of the
world's sexually active men and woman and every child over 9 years of age
are potential customers for the expensive course of injections.
A quick and successful launch was crucial, both for Merck's failing
financial health and because rival GlaxoSmithKline was developing a
similar HPV vaccine. Things looked good for Merck when the U.S. Food and
Drug Administration (FDA) agreed to fast-track Gardasil in February 2006 and
approved it in June, pronouncing the vaccine effective and safe for girls as
young as nine. Soon after the FDA approved Gardasil, WIG was helping
introduce bills in some 20 states, with Merck actually writing the
legislation in at least one state: Florida.
Merck also launched a subtly frightening advertising campaign featuring
quick images of vital young girls: a young drummer, a child with a
skateboard, two playing basketball, and three skipping rope. The drummer
says:
"I want to be one less woman who will battle cervical cancer,"
as she starts tosses her drumsticks and starts to play, the others spell out
a chant: : "O-N-E-L-E-S-S. I want to be one less. One less."
Merck's targeting of young girls and eventually boys who are carriers
and on rare occasions develop HPV-caused cancers is based in rational
public health principles. Since the vaccine is only effective in preventing,
not treating HPV infection, it needs to be dispensed before exposure to the
viruses. And while 11-12 year old girls are unlikely to be sexually active,
policy makers could make their entry into middle school contingent on
vaccination in the same way that 5-6 year olds are required to be vaccinated
for polio and measles before entering elementary school. If officials waited
until the more common age of sexual initiation, around 16, public health
officials would not have the leverage to compel vaccination.
As with any new drug, concerned parents and public health officials had to balance Gardasil's obvious promise against potential problems. They understood that Merck's contention that its HPV vaccine is safe and effective was only as sound as its data and only as solid as the independence and rigor of the FDA review process that approved the drug. But while most people applauded the new protection Gardasil offered, both experts and consumers found good reasons for waiting before making the vaccine mandatory. (They did not include fears that all vaccines are dangerous, or that protecting against a sexually transmitted disease encourages girls to have sex.)
The data Merck presented to
the FDA were based on some 21,000 test subjects between ages 16 and 26, half
of whom received Gardasil and half a placebo. All subjects, followed for up
to five years, were found free of pre-cancerous changes from the targeted
strains.
Some critics pointed out
that the test period was too short to assess long-term effects and efficacy.
In fact, the studies on children, who often react differently to drugs, were
shorter yet, and smaller. Only 1,184 subjects in the nine to 15 year-old age
test group got Gardasil, and they were followed for 18 months, according to
New Scientist magazine.
A Merck spokesperson refused to break down the data further to reveal how
many of that small sample were below the age of puberty.
And then there is the
possibility that, given time and real-world conditions, side effects will
emerge. FDA briefing papers noted a small increase in birth defects in the
babies of women given the vaccine within 30 days of becoming pregnant over
those who took a placebo. The number, while not establishing causality,
triggered an FDA recommendation that pregnant women not be vaccinated. The
background documents also raised questions about whether selectively
targeting a few HPV viruses (there are more than 100) would "advantage
others." Another concern "was the potential for Gardasil to enhance disease
among" subjects already infected "with vaccine-relevant HPV."
Is mandatory vaccination cost effective?By promoting vaccination as a public health imperative mandated by
government, rather than as a private choice, Merck has opened the door
to the inherently uncomfortable discussion of whether mandatory
vaccination is cost effective. Since Gardasil protects against the two
strains of HPV that cause 70 percent of cancers, women will still need but may be less likely to get Pap smear tests to catch the signs of cancers caused by the
other 30 percent of dangerous strains. |
These kinds of concerns are
not necessarily alarming or unusual for a new drug, According to a 2002
study in the Journal
of the American Medical Association,
"The safety of new agents cannot be known with certainty until a drug has
been on the market for years. Serious ADRs [adverse drug reactions] commonly
emerge after Food and Drug Administration approval."
"The published data look
great, but at the very least, I would like to see efficacy data among 11 and
12 years old, which won't emerge until they are sexually active," says Karen
Smith-McCune, a University of California associate professor of obstetrics
and gynecology.
And so too, would many
medical experts, public health officials and consumers. The American Academy
of Pediatrics had urged the company to go slow and focus first on raising
public awareness of HPV and monitoring the vaccine's safety. The U.S.
Centers for Disease Control panel that recommended routine HPV vaccination
told Merck that it opposed making Gardasil mandatory, the
Washington Times
reported.
In addition to questions
about the data, was the FDA approval process itself. The drug was
recommended for approval by the FDA's advisory committee comprised of
"qualified experts with minimal conflicts of interest ... [who] provide FDA
with independent advice," according to agency guidelines. While the
committee's recommendations are not binding, the FDA almost always accepts
them.
But at least two members of
the advisory panel that found Gardasil safe had the appearance of a conflict
of interest: They were former Merck employees connected with development of
the vaccine. Vaccine expert Dr. John Boslego was executive director of
Biologics, Clinical Research at Merck for ten years, and had left the
company just two months before the committee ruled on Gardasil in February
2006. Another panel member, Alan Shaw, was part of Merck's Vaccine &
Biologics Research and had represented the company as late as May 2005 at a
conference on cervical cancer where he presented a paper on HPV Vaccines.
The FDA granted waivers to both men, finding them free of any conflicts of
interest.
The integrity of the FDA
review process is also vulnerable to charges of conflict of interest over
the fees the cash-strapped agency accepts from the drug companies. Under a
law sponsored by U.S. Senator Richard Burr a decade ago, the FDA charges
from nearly $50,000 to nearly $900,000 to fast track a drug, according to
the Winston-Salem
Journal. Since 1992,
drug companies have paid the FDA $1.7 billion to speed up the approval
process for particular drugs.
Of course, none of this
means that Gardasil is unsafe. Few things in medicine are guaranteed, and
many believe that the odds are that Gardasil is exactly what Merck says it
is: a life-saving breakthrough with no significant side effects.
A Controversy in Texas
But new drugs, and vaccines
in particular, raise not only promise but fear. And touching as it did on
issues of teenage sexuality, Gardasil was particularly controversial.
Religious conservatives,
already concerned that vaccination would encourage sexual activity, opposed
making vaccination mandatory. "My main reason is that it is parents that
have the right to decide when is the appropriate time to discuss sexuality,"
said Debi Vinnedge, the head of Children of God for Life. "One of my young
grandchildren is more mature, but there is nothing that I can say to these
kids" that won't send the wrong message.
It was perhaps the
potential controversy in mind that Texas governor Rick Perry took the bull
by the horns and circumvented abstinence junkies, public discussion, and the
legislature to issue an executive order requiring vaccination for all girls
entering the sixth grade, unless parents opted out.
Perry's February unilateral
decision sparked a public relations disaster that Merck's orchestrated ad
campaigns, lobbying efforts through WIG, and courting of the religious right
had failed to anticipate.
Perry's February order also
raised suspicions over his politics (the governor has previously shown
little interest in health policies), his speed (just months after the FDA
approved the vaccine and before all the data had been published), the
financial arrangements (Merck got a statewide monopoly without concessions
and without negotiating a discount for clinics and poorer Texans) and the
stealth timing (Perry issued the order late on Friday before Super Bowl
Sunday, the nation's
biggest sporting event).
Questions about cronyism
soon led to Perry insiders connected to Merck and to WIG: The WIG state
director is the mother-in-law of Perry's current chief of staff, and his
former chief of staff is now one of Merck's three Texas lobbyists. A Merck
executive served on WIG's Business Council in 2006.
And then there was the
money trail. In September, greasing the skids for Gardasil's November public
relations blitz, "Merck's
PAC spent $74,250 in a single day to influence elections in five states. It
directed 60 percent of that money to 82 candidates in Texas," according to
Lobby Watch,
a newsletter put out by Texans for Public Justice. (A Public Action
Committee or PAC is an advocacy group that buys political advertisements to
support elections or legislation).
In late February, less than
three weeks after Perry's executive order to make the vaccine mandatory for
all Texas schoolgirls entering sixth grade, Merck abandoned the lobbying
campaign.
"Our goal is to
prevent cervical cancer,"
Dr. Richard M. Haupt, executive director for medical affairs in Merck's
vaccine division told the
Associated Press.
"Our goal is to
reach as many females as possible. Right now, school requirements and Merck's
involvement in that are being viewed as a distraction to that goal."
A Financial Shot in the
Arm
Facing the storm of
controversy that threatened to overwhelm news about preventing cancer, Merck's
president for vaccines, Margaret McGlynn, defended her company.
"Each and every day
that a female delays getting the vaccine there is a chance she is exposed to
human papilloma virus,"
she told the New York
Times.
But Merck, like any
corporation, is motivated by more than altruism. If Gardasil becomes
routine, the $360-$400 course will generate annual sales of $3.2 billion by
2010.
Merck needs this financial
shot in the arm to offset liabilities caused by Vioxx, its arthritis drug
that may have caused almost 28,000 deaths, according to FDA estimates. Merck
now faces some 4,000 lawsuits and potentially billions in payouts. In one
Texas liability trial, lawyers produced documents and e-mails from Merck
scientists discussing Vioxx's potential heart risks as early as 1997, more
than two years before it went on the market.
This history of hiding data
has done little to reassure Gardasil skeptics. "It used to be that funding
for research was provided by government,"
says Canavan, the
Maine legislator. "But now it comes from private corporations that stand to
gain and the information can be - I won't say skewed - but made to work for
the company."
What is clearly not working
for Merck are the controversies around Gardasil that have derailed corporate
plan to make vaccination mandatory and to capture the market before Glaxo
releases its own vaccine.
The last few years have not
gone smoothly for one of the world's biggest drug companies. On September
30, 2004, after it became known that Vioxx was doubling the rate of heart
attacks and strokes, Merck withdrew the painkiller and saw its stock plummet
nearly 27 percent. Taking the drug off the market wiped out $2.5 billion in
annual sales.
In 2005, Merck's new chief
executive officer Richard Clark announced a plan to cut the company's
world-wide work force by 11 percent or 7,000 jobs and to close or sell five
of its manufacturing facilities. The company's 2005 sales were down four
percent and its net income had fallen by 20 percent. The company's financial
woes will not be eased by the fact that its patent for cholesterol drug
Zocor, with $5 billion in sales, expired in 2006, while patents on other
best selling drugs, including, Folsom and Cozaar, are nearing expiration.
Merck's also announced on
February 14 that it had signed an agreement that essentially brings to a
close the U.S. Internal Revenue Service's
(IRS) examination of the company for the period 1993-2001. Under the
agreement, the final net cash cost to Merck is expected to be approximately
$2.3 billion which covers federal tax, net interest after federal tax
deductions and penalties." Merck, noted the "reasonableness" of the IRS
settlement and said that it had reserved the funds so the payment would not
impact 2007 earnings.
"As CEO, my priorities are
clear," says Clark, "meeting the needs of patients and building shareholder
value."
Those priorities are
particularly hard to juggle given America's love-hate relationship with
pharmaceuticals. In 2004, 82 percent of the U.S. population reported that
they had taken at least one prescription drug, over-the-counter medication,
or dietary supplement in the previous week; 30 percent of respondents
reported using five or more, according to a study by the Sloan Epidemiology
Center at Boston University. Even kids are consuming drugs in great
quantities. In 2005, according to an analysis performed by Medco Health
Solutions for the New
York Times,
"approximately 1.6 million U.S. teenagers and children (almost 300,000 of
whom were under 10) were given at least two psychiatric drugs in
combination."
At the same time as they
are popping pills, Americans are widely distrustful of a pharmaceutical
industry that has a long record of marketing wonder drugs with misleading
advertising and dangerous side-effects. A 2007 health poll by the Kaiser
Family Foundation found that fewer than 18 percent of Americans "say they
can trust what pharmaceutical companies say in their ads most of the time."
Some 70 percent "agree that drug companies put profits ahead of people."
By choosing to promote
making Gardasil mandatory, Merck fell deep into the chasm between the
public's desire to see drugs as the cure for all ills and its profound
skepticism that pharmaceutical companies put the public's interests before
profits.
"When we lose trust in
company like pharmaceuticals or a group like Women in Government," said
Canavan from her home in Maine, "we start to become suspicious about
everything. We need to have public dialogue. The point is not that the
vaccine is bad, but that the public agenda has all been company-driven."
http://www.corpwatch.org/article.php?id=14401
