Although initially rejected as ethically questionable, industry funding was eventually sought and used by researchers developing a list of preferred psychiatric drugs for children in state care, according to documents reviewed byThe Dallas Morning News. And a spot on the program could have meant millions to drugmakers.
The documents released to The News were collected by the Texas attorney general's office, which is suing Johnson & Johnson's Janssen Pharmaceutica for allegedly trying to influence researchers on a similar adult drug plan, Texas Medication Algorithm Project, or TMAP.
Citing the pending lawsuit over TMAP, 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 (back story). The researchers have insisted drugmakers never influenced their work. The CMAP records obtained by The News don't refute this. Nor were the researchers banned from soliciting funding from drugmakers. The documents show officials...
• Discussed the need to defeat a bill in the Legislature that would have banned the use of psychiatric drugs in foster children younger than 5. They indicated the bill would prevent children from getting the medical treatment they need. The bill never made it past a legislative committee;
• Considered incentives to get children enrolled in trials, including offering them gift certificates to Blockbuster and McDonald's. It's unclear whether the incentives were ever offered.
• Reduced info on child suicide risks in one of their published papers, at the request of an editor at the Journal of the American Academy of Child and Adolescent Psychiatry, who wrote: "Please drastically prune this section. Even the detailed discussion of risk factors for suicide is out of place in a paper reporting a medication algorithm."
• Accepted complaints and feedback on a n adult psychiatric drug list from Lilly and Janssen, which donated grants to research protocols. The changes requested prompted one longtime mental health advocate to question "the influence of the pharmaceutical industry in our processes overall." A state official who responded to the advocate said they took all industry suggestions with a grain of salt;
The records reflect a common pattern in state and university medical programs, the paper writes. Unable to get ample government funding, researchers are increasingly forced to rely on industry, even when it's their last resort, the News points out.
When CMAP was started in the late 1990s, researchers were loath to accept industry grants. 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 changed their minds. CMAP's director, M. Lynn Crismon, head of the University of Texas College of Pharmacy, wrote to at least 10 drugmakers, 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 Labs, and $70,000 from 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 industry connections to TMAP, however, CMAP researchers were again cautious about pharma money.
And as recently as this spring, Crismon assured top state health officials there was no pharma link to CMAP, saying that any industry 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 Lilly and Forest money "was not for CMAP."
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 wrote. "No pharmaceutical company funding should be a part of this."
Speaking through a UT attorney, 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.