[Ip-health] Merck's Murky Dealings: HPV Vaccine Lobby Backfires

[Riaz K Tayob]

Merck's Murky Dealings: HPV Vaccine Lobby Backfires
by Terry J. Allen, Special to CorpWatch
March 7th, 2007

cartoon by Khalil Bendib

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 =C3=A2=E2=82=AC=E2=80=9C they were not discussi=
ons =C3=A2=E2=82=AC=E2=80=9C 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 =C3=A2=E2=82=AC=E2=80=9C 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 =C3=A2=E2=82=AC=E2=80=9C and eventually bo=
ys who are
carriers and on rare occasions develop HPV-caused cancers =C3=A2=E2=82=AC=
=E2=80=9C 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."

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."

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