STUDY: GENERIC THYROID DRUG JUST AS GOOD.

Byline: Lawrence K. Altman The New York Times

Concluding a dispute that raised questions of academic integrity, a pharmaceutical company has permitted publication of a long-suppressed study that showed its widely used thyroid drug was no more effective than less expensive generic versions of the drug.

The findings are being published today in The Journal of the American Medical Association after the company, which had financed the study in the hopes that its drug would be proved superior, said it would no longer object.

The study compared four versions of levothyroxine, a hormone replacement given to about eight million Americans with underactive thyroids. One of the four was the company's brand-name version, Synthroid, which is the third most widely prescribed drug in the United States.

The researchers at the University of California at San Francisco found that for most patients the less costly generic forms of the drug worked just as well as Synthroid and another brand-name version, Levoxyl or Levoxine, which is similar in price to the generic drugs.

More than $350 million might be saved each year if doctors prescribed generic instead of brand-name forms of levothyroxine, said the authors of the study, which was led by Betty J. Dong, a pharmacy professor at the university. For some patients, however, brand-name thyroid drugs may be better than generic forms, Dong's team said.

An editorial in the journal said the company that financed the study had waged an energetic campaign to discredit the work and had refused permission for Dong to publish the findings. The editorial chided the university for failure to defend academic freedom in the dispute between researcher and sponsor.

Boots Pharmaceuticals Inc., a forerunner of Knoll Pharmaceutical Co. of Mount Olive, N.J., which makes Synthroid, gave Dong's team a $250,000 grant in 1987 to carry out the study. The findings were a surprise to both the drug company and Dong. Both had expected the study to show that Synthroid was superior.

When Dong received the grant, she signed an agreement not to publish the findings without the drug company's explicit permission. Dong told editors of the journal that she had assumed that academic researchers signed such clauses. Indeed, the journal said, the practice was common at Dong's university until 1993, when it began requiring centralized review of such contracts.

Dong and Joseph B. Martin, the university's chancellor, declined to be interviewed or to comment beyond what they had published in the journal.

The journal's editorial, written by its deputy editor, Dr. Drummond Rennie, who also is a faculty member of the University of California at San Francisco, directed its harshest criticism at the university's administration and faculty, but it also criticized Knoll, the Food and Drug Administration and professional societies.

The journal also published a letter from Carter H. Eckert, the president of Knoll, who apologized for blocking publication of Dong's paper, saying it was ``contrary to our normal practice.'' He expressed ``regret that our decision was interpreted as lack of support for academic freedom.''

Eckert said in an interview that he was confident that debate among scientists about the findings would vindicate Knoll's view that ``the study was significantly flawed'' and that switching from Synthroid to other forms of levothyroxine could put millions of patients at risk.

Knoll, Eckert said, ``has been attempting to get this information out into the open, in a balanced view with all the facts on the table, for some time.''

The FDA came under attack in the editorial for not setting specific standards for determining the amounts of levothyroxine that reach the blood, which can help clarify whether generic forms of the drug are working as well as brand names.