The results removed for more than 2 years by a pharmaceutical company that sponsored the research will finally appear in tomorrow's edition of Journal of American Medical Association ( JAMA ). The report suggests that drugs of generic thyroid are as effective as their brand name counterparts and said that 8 million Americans could save up to $ 365 million per year by switching to the cheapest pills. Beyond the results, experts say, the long journey to publication paper reflects the potential pitfalls of research funded commercially.
The study was to explore why different brands of levothyroxine thyroid drug, a synthetic version of the hormone thyroxine, seemed to affect patients differently. Boots Pharmaceuticals of Lincolnshire, Illinois, the manufacturer of Synthroid - the oldest synthetic version of the drug - has decided to finance a study of the University of California, San Francisco (UCSF), pharmacologist Betty Dong to test Synthroid, another brand Levoxine called, and two generic brands in 22 women whose thyroids were damaged or had been removed. All women received each drug for 6 weeks at a time in random order, and the researchers measured the levels of thyroid hormones in the blood during treatment. Dong and his team found that while hormones values fluctuated, there was no significant difference between the four preparations. They concluded that generic drugs are just as effective for most patients Synthroid.
When Dong shared the results with those responsible Boots, they charged that the study had major flaws, wrote JAMA Deputy Editor Drummond Rennie in an accompanying editorial. Although a thorough investigation by the authorities in response to UCSF Boots complaints found minor problems, easily correctable, Rennie said, Boots refused to allow publication of the study. However, researchers have submitted their manuscript to JAMA without mentioning the conflict. The newspaper accepted the paper and scheduled for publication January 25, 1995. On January 13, however, Dong wrote a letter to JAMA withdraw the manuscript because of what she calls "a lawsuit imminent by Boots Pharmaceuticals Inc. against UCSF and their investigators. "the contract she had signed with Boots said the data could be published with the permission of the company, and the UCSF lawyers said they could not defend Dong if it continued.
Last April, however, the Wall street Journal ran a front page article detailing the saga. After the media storm that followed Knoll Pharmaceuticals of Mount Olive, New Jersey, who bought boots in 1995, agreed to let JAMA publishes the paper. spokeswoman Linda Mayer company said that although the company still claims study is wrong, "when The Wall Street Journal item was released a year ago, he took a life." Knoll said she is "pleased that the study has now been published so it can be thoroughly evaluated."
Experts say the results are probably not the last word on the subject. "This is a further study," says endocrinologist Chester E. Ridgeway from the University of Colorado Medical Center, "which is now in a list of publications, some in favor and others against." But it should give pause to medical researchers who are considering working for the industry, says Rennie. "When the industry gets in bed with academia, their programs and their backgrounds are so different that you'd better be damn careful that you do not end with the removal of unfavorable results or - worse -. dangerous results, "he said
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