State medication protocol researchers sought money from drug firms
12:00 AM CDT on Sunday, October 26, 2008
AUSTIN – Pharmaceutical company money, initially rejected as being ethically questionable, was eventually sought and used by researchers developing a list of preferred psychiatric drugs for children in state care, according to documents reviewed by The Dallas Morning News.
A spot on the since-suspended children's drug plan could have meant millions to pharmaceutical firms. The documents released to The News were collected by the Texas attorney general's office, which is suing a pharmaceutical company accused of trying to influence researchers on a similar adult drug plan.
Citing the pending lawsuit over the adult plan, officials in two state health agencies declined to comment on the Children's Medication Algorithm Project, or CMAP – which was put on indefinite hold in May. The researchers have insisted that pharmaceutical companies never influenced their work.
The CMAP records obtained by The News don't refute this. Nor were the researchers banned from soliciting funding from drug companies.
However, the records reflect a common pattern in state and university medical programs. Unable to get ample government funding, researchers are increasingly forced to rely on drug company money – even when it's their last resort.
When CMAP was started in the late 1990s, researchers were loath to accept pharmaceutical grant funding. At an April 1998 meeting, "it was concluded that we should try to avoid this if possible," according to minutes of a meeting between CMAP researchers.
By June 1999, researchers needed more grant money and had changed their minds. CMAP's director, M. Lynn Crismon, head of the University of Texas College of Pharmacy, wrote to at least 10 drug companies, asking for donations.
"Although we have received grant funding in support of this effort," he wrote, "these amounts fall short of the funds required to complete this important outcomes project."
By late that year, CMAP budgets included pledges for $10,000 a year from Wyeth and Pfizer, an $80,000 one-time grant from Forest Laboratories, and $70,000 from Eli Lilly. While a few of the line items seem to limit the grant to CMAP's "patient and family education" program, others are listed as unrestricted CMAP "research gifts."
When, in 2006, questions surfaced about drug company connections to the adult drug plan, however, CMAP researchers were again cautious about drug company money.
And as recently as this spring, Dr. Crismon assured top state health officials there was no pharmaceutical link to CMAP, saying that any drug company money was used for a patient and family education study unrelated to CMAP.
"No pharma funding has ever been received for CMAP to the best of my knowledge," he wrote. The Eli Lilly and Forest money "was not for CMAP."
Eli Lilly officials, however, confirmed that the company donated $70,000 to the state for a CMAP education program.
These mixed messages seem to have made their way to the top. In a 2007 e-mail, Department of State Health Services Commissioner David Lakey asked Bill Race, then the agency's medical director for behavioral health, for a meeting to discuss an outside review.
"I will give you more background when we meet, but we will need to put together a group to review it and make sure the algorithms truly represent best practice as of 2007," he said. "No pharmaceutical company funding should be a part of this."
Speaking through a UT attorney, Dr. Crismon told The News that he believes CMAP was funded entirely by the state, but that he didn't have the records available to check.
Staff writer John Jordan contributed to this report.
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