Research on Thyroid Tablets Found Cheap Ones Were Just as Good as Sponsor's

By Ralph T. King Jr.
Staff Reporter for
The Wall Street Journal

San Francisco - It was one of those impenetrable research papers full of statistics and six syllable words. But its stark conclusion could have cut medication costs for millions of people and might have disrupted a billion-dollar deal.

If only it had been published.

The paper concerned a drug called Synthroid, the main product of a British pharmaceutical company and drugstore chain Boots Co. Synthroid is taken daily by about 8 million Americans to control hypothyroidism, a metabolic disorder. It dominates the $600 million U.S. Market, so much so that when Boots put its drug its drug division up for sale, Germany’s BASF AG agreed to pay a loft price of $1.4 billion for it.

Synthroid has a lock on the U.S. Market because makers of rival products have long been unable to resolve doubts that their pills work exactly the same - that they are "bioequivalent". Many doctors have remained leery of using the rival drugs even though they cost about half as much or less.

But just a Boots and BASF were about to seal their deal, an authoritative demonstration of bioequivalency was at hand.

Peer-Reviewed Study

A research team headed by Betty Dong at the university of California at San Francisco had concluded that Synthroid and three cheaper drugs were essentially interchangeable. The study had with stood intensive review by experts at USCF not connected with it.

The study’s sponsor was Boots.

Corporate Sponsorship

The Synthroid affair illustrate what some leading scientists decry as increasingly frequent corporate attacks on open scientific debate, at a time when industry-supported research is crucial because of a shrinking government role in medical research.

In a recent article in the new England Journal of Medicine, Steve A. Rosenberg, Chief surgeon of national Cancer institute, cited what he said were four instances of promising research being squelched or slowed by corporate sponsor’ demands for secrecy to preserve possible competitive advantage. It is an "insidious problem," he wrote, one that "has escalated dramatically in the past decade and is of medical research."

Boots says it had a contractual right to prohibit publication of the research and did so for scientific, not business, reasons. It contents the study’s conclusion was invalid because of numerous missteps in managing patients and analyzing data, and argues that because USCF officials were unwilling to intervene, it had no choice but to take a hard line. "I did what I had to do," says Carter Eckert, who launched the study while a Boots executives. "I stopped a flawed study that would have put millions of patients at risk."

Leslie Benet, chairman of USCF’s biopharmaceutical sciences department, scoffs at this. "The Boots people did everything they could to make sure this study didn't get published because it was detrimental to their company," he says.