Ties to Drug Company Raise Vaccine Questions

Chicago Sun-Times
January 27, 2002

BY JIM RITTER, HEALTH REPORTER

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

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 conferences.

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 recommendations."

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