ROANOKE TIMES
Copyright (c) 1997, Roanoke Times
DATE: Wednesday, April 16, 1997 TAG: 9704160057
SECTION: NATIONAL/INTERNATIONAL PAGE: A-3 EDITION: METRO
DATELINE: CHICAGO
SOURCE: ASSOCIATED PRESS
An estimated 8 million Americans could have saved $356 million a year on a synthetic thyroid hormone.
For more than six years, a drug manufacturer suppressed research that could have helped an estimated 8 million Americans save $356 million a year by using cheaper alternatives to the company's synthetic thyroid hormone.
Knoll Pharmaceutical Co. finally threatened to sue to halt publication of a study that could topple its near-monopoly on the $600 million retail market for the drug, the study's lead author told the Journal of the American Medical Association. The journal published the research today for the first time.
Knoll said it had scientific objections to the study.
With the drug industry spending millions each year on medical studies, the episode raises questions about the companies' influence over research findings on which their profits may depend.
``We don't know whether things have been locked up in laboratories that could save lives,'' said Dr. David Blumenthal of Massachusetts General Hospital. ``That is probably overdramatic, but I do think there is probably some delaying ... slowing the progress of science.''
Knoll's product, Synthroid, controls 85 percent of the market for synthetic thyroid hormone, used by people whose thyroid glands have been damaged by disease or have been surgically removed.
Thyroid hormones regulate metabolism, the chemical activity in cells that releases energy from nutrients or fuels the manufacture of other substances, such as proteins.
Synthroid dominates the market in part because it was the first synthetic thyroid hormone. Natural thyroid extracts had been marketed for years before federal rules required a scientific benchmark for the drugs' effectiveness.
In 1987, Synthroid's manufacturer - at the time, Flint Laboratories - commissioned a study of the drug. Betty J. Dong, a pharmacist at the University of California at San Francisco who had published findings suggesting Synthroid might be superior, was hired to compare Synthroid to three other, similar drugs.
Her study showed clearly that the cheaper competitors - one brand-name drug and two generics - worked just as well as Synthroid for thyroid deficiency.
Over the next four years, the company tried to discredit the study and prevent its publication, the journal said in an editorial.
After demands for revisions and a university investigation that found no problems with the work, the study was sent to the journal and slated for publication in January 1995.
Twelve days before it was to appear, Dong suddenly withdrew the manuscript, saying Knoll had threatened to sue because her contract prohibited publication without the manufacturer's OK.
The company has adamantly denied making such threats but said it withheld its permission because of scientific objections to the study.
The manufacturer still faults the study but agreed to publication, partly at the urging of the Food and Drug Administration and of former U.S. Health Secretary Dr. Louis Sullivan, who is on Knoll's board, the editorial said. JAMA had five outside experts review the work and judged it sound.
Synthroid costs two to three times as much as its competitors. At a Walgreen's drug store in Chicago this week, 100 tablets of a typical daily dose of Synthroid cost $22.99. The same amount of Levoxyl, a brand-name alternative, cost $6.99. At those prices, a year's supply of Synthroid would be $83.91 and of Levoxyl would be $25.51.
The incident is hardly unique, according to another study in today's journal. About one in 20 faculty members at universities that do life-science research said publication of their research has been delayed for months when it yielded ``undesired results.''
LENGTH: Medium: 74 linesby CNB