Drugmaker ties impacted guidelines, critics say
CHICAGO – Should all U.S. children get tested for high cholesterol? Doctors are still debating that question months after a government-appointed panel recommended widespread screening that would lead to prescribing medicine for some kids.
Fresh criticism was published online today in Pediatrics by researchers at one university who say the guidelines are too aggressive and were influenced by panel members’ financial ties to drugmakers.
Eight of the 14 guidelines panel members reported industry ties when their advice was published in December. They contend in a rebuttal article in Pediatrics that company payments covered costs of evaluating whether the drugs are safe and effective but did not influence the recommendations.
It also is not uncommon for experts in their fields to have received some consulting fees from drug companies.
Even so, the ties pose a conflict of interest that “undermines the credibility of both the guidelines and the process through which they were produced,” says the commentary by researchers at the University of California at San Francisco. The authors are Dr. Thomas Newman, a researcher and former member of a Food and Drug Administration pediatrics advisory committee, and two heart disease researchers, Drs. Mark Pletcher and Stephen Hulley.
Pletcher has received research funding from drug and device makers; the other authors said they had no relevant industry ties.
Other criticism was published earlier this year in the Journal of the American Medical Association. That critique raised concerns about putting children on cholesterol drugs called statins, noting the medicine has been linked with a rare muscle-damaging condition in adults. Those authors were heart specialist Bruce Psaty and pediatrician Frederick Rivara, both of the University of Washington in Seattle.
JAMA included additional criticism from a dissenting member of the panel that produced the kids’ cholesterol guidelines, Dr. Matthew Gillman of Harvard Medical School. He recommends more narrow screening based on family history of cholesterol problems.
The guidelines are endorsed by the Academy of Pediatrics, which publishes the journal that carried the critical commentary. The guidelines aim to help prevent and treat conditions in children that put them at risk for later heart-related problems. At least 10 percent of U.S. children have unhealthy cholesterol levels and one-third are overweight or obese.
The critics say there’s little evidence that widespread cholesterol testing and treatment in children will reduce their chances of having later heart problems. They argue that widespread testing is costly and could cause anxiety in healthy children who don’t need treatment.
The National Heart, Lung and Blood Institute appointed the guidelines panel. Dr. Susan Shurin, the institute’s acting director, said there are few qualified specialists who have no industry relationships, and that panel members were selected for their expertise.
“We got the best people in the country to do this,” Shurin said.
Dr. Stephen Daniels, chairman of the guidelines panel, is pediatrics chief at the University of Colorado School of Medicine. He has worked as a consultant or advisory board member for Abbott Laboratories, Merck and Schering-Plough, now part of Merck, and co-authored the Pediatrics rebuttal.
Daniels said industry ties “were vetted during the discussions of the panel and I think really did not influence the debate.”
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