Ties to drug company raise vaccine questions


January 27, 2002


Next fall, thousands of Illinois schoolchildren are likely to have to get a
chickenpox vaccine, under orders from the state health department.

The department followed the recommendation of a panel of experts, its
Immunization Advisory Committee, while rejecting the advice of others who
thought the decision should be left to parents and pediatricians.

But in what critics consider a conflict of interest, 5 of the committee's 18
members have financial ties to Merck, which makes the chickenpox vaccine.

Two members of the committee have given talks for Merck, receiving up to
$750 per speech. A third member directs a nonprofit group that has received
$20,000 in grant money from the company. And two other members own stock in
Merck, including one who has owned as much as $16,000 worth.

Though only one of these five members of the committee participated in the
vote to recommend making the vaccine mandatory, the others participated in
the discussion, committee member Fran Eaton said.

Last year, the Illinois House and Senate unanimously passed a bill that
would have banned anyone with financial ties to pharmaceutical companies
from serving on the committee. But Gov. Ryan, who has received $9,000 in
campaign contributions from Merck, vetoed the bill, and the Senate failed to
override the veto. The bill was sponsored by Sen. Patrick O'Malley (R-Palos
Park), who is running for governor.

Since 1994, Merck has contributed $75,050 to political candidates in
Illinois, including Ryan.

Merck spokesman Christopher Loder said Merck seeks to "have a voice in the
debate about the most effective means to achieve the goal of improving the
state of health care." Mandating the chickenpox vaccine, he said, "is good
public policy."

When Ryan vetoed the bill last year, he said the restrictions on financial
ties to drug companies would have severely limited the number of
pediatricians, infectious disease specialists and other experts who could
serve on the committee. Ryan noted that members are required to disclose
financial interests in drug companies that exceed $5,000 and abstain from
votes if they have a conflict of interest.

"The people who do this work are principled people," said committee member
Robyn Gabel, executive director of the Illinois Maternal and Child Health
Coalition. "The amount of money they get from the companies is not enough to
do something that is harmful."

But critics say the financial ties damage the committee's credibility. "It's
outrageous that Gov. Ryan vetoed this," said Dr. Linda Shelton, an Oak Lawn
pediatrician. "If you have even the appearance of impropriety, people won't
trust you."

On the federal level, members of committees that advise the Food and Drug
Administration and the Centers for Disease Control and Prevention on vaccine
policy also often have conflicts of interest, according to a report of the
House Government Reform Committee. The FDA approves vaccines, and the CDC
issues guidelines for their use.

The federal report examined the financial interests of expert advisers who
endorsed a rotavirus vaccine to prevent childhood diarrhea. Shortly after
the vaccine was approved, it was pulled from the market after being linked
to severe bowel obstructions in babies that caused vomiting and bloody
stools and sometimes required surgery.

The House committee report documented that members of the FDA and CDC
advisory committees held stock in vaccine companies, owned vaccine patents,
received grants and research funds from vaccine manufacturers and were paid
speaking and consulting fees. Some of these members abstained from the vote
to approve the rotavirus vaccine, but still participated in committee
discussions, the report said.

"We've taken a good hard look at whether the pharmaceutical industry has too
much influence over these committees," said committee chairman Dan Burton
(R-Ind.) "From the evidence we found, I think they do."

The issue is part of a larger debate over whether the pharmaceutical
industry wields too much clout over the nation's medical practices and
health policy. Drug companies routinely give doctors free meals, medical
textbooks, drug samples and generous speaking and consulting fees. Companies
that develop new drugs pay for the studies that determine whether the drugs
will be approved for use. Drug companies also are a major source of
advertising dollars for medical journals, and they help pay for medical

Eaton, a non-medical member of the state immunization advisory committee and
the only member to vote against the chickenpox vaccine, said she was "amazed
at the number of lobbyists from pharmaceutical companies that attend these
meetings." Industry representatives, she added, are on a first-name basis
with committee members and sometimes participate in discussions.

In April 2000, the committee voted 6-1 to recommend requiring the chickenpox
vaccine. Seven members were absent, three abstained and one recused himself,
citing a conflict of interest. Eight months later, the health department
received conflicting advice. The state Board of Health voted 4-3 against
making the vaccine mandatory.

Health board member Ernst Ott said people who attended three public hearings
expressed overwhelming opposition to requiring the vaccine. And board member
Colin McRae said there is no "far-reaching public health issue" to justify a
mandatory vaccine.

Last October, Dr. John Lumpkin, the state's public health director, decided
to make the vaccine mandatory. He said he weighed the advice from both
committees, along with recommendations in favor of the vaccine from the CDC,
the American Academy of Pediatrics, the American Academy of Family
Physicians and his staff.

"It would not be fair to say that one committee had more weight than the
other," said Lumpkin, whose order still must be reviewed by a legislative
committee. "It was the sum total of all the information and