Synthroid Under Siege

Lawsuit Stalled, Congress Tackles Overpricing, Research Says It May Not Be Enough

It looks like the long reign of Synthroid ^TM may be under siege after a decade of increasingly bad luck, culminating with the latest developments.

First, the manufacturer, Knoll Pharmaceuticals, commissioned research to prove that Synthroid is better than its competitors. Surprise, surprise, the research showed otherwise, finding that Synthroid is bioequivalent, and thus no better, than competitive brand name levothyroxine products.

Then Synthroid didn't release the research results for seven years, until a major fracas in April of 1997 resulted in the Journal of the American Medical Association publishing the researchover protest from the manufacturer, who was now discrediting the reseach they had funded, and claiming the results were invalid.

No sooner did that revelation hit, than a class action suit was filed in May 1997 against the manufacturer, stating that because patients overpaid for Synthroid, as much as two to three times the price of competitors' products, for as long as the seven years the research wasn't released, there should be compensation for that overpayment.

In the middle of all that, the Food and Drug Administration decided that Synthroid and its competitors, who had never gone through the process of a new drug application to prove their products were reliable and safe, would now have to do so, due to serious stability and potency concerns. The new drug application process for levothyroxine is a lengthy and costly process that the company had thought they would be able to avoid.

That announcement was followed by a "fast-track" settlement "agreement" that would have benefited law firms and the drug maker -- and not patients. That agreement was thrown out by the judge, and the whole settlement process is now in jeopardy, leaving open the possibility that the suit may actually go to trial, or be settled for far more than the initial offer.

Now, Synthroid finds itself being touted by Congress as an egregious example over how seniors paying out of pocket for drugs can be charged as much as 1500 percent more for Synthroid than insurers or HMOs. Add to that the February 11, 1999 research article from the New England Journal of Medicine that says that most hypothyroid patients feel better taking not just Synthroid (or its competitive levothyroxine products) alone, but only in conjunction with another thyroid hormone that isn't manufactured by Knoll Pharmaceutical.

All I can say is...it's about time. Here are the details. . .

In mid-August of 1998, Federal Judge Elaine Bucklo of the U.S. District Court for the Northern District of Illinois blocked the proposed $98 million settlement of the class action suit against Knoll Pharmaceuticals, manufacturer of Synthroid. The Wall Street Journal reported on this story on September 2, 1998. I've been in contact with the reporter, Ralph King, since the early days of the class action process, and the following is an quote from his article that quoted me:

Consumer advocates said they will press for a deal that better reflects damages from Knoll's alleged fraud. Damage estimates range from $500 million to $1.5 billion, court records show. "I applaud the judge for recognizing what thyroid patients have suspected all along, namely that the settlement was driven by economics of the class-action process and not by the best interests of millions of patients," said Mary Shomon, editor of Sticking Out Our Necks, an Alexandria, Va., newsletter for thyroid patients."

While Knoll believes the settlement is fair, consumer groups, attorneys generals, and others, including me, protested that the deal was compensating law firms millions of dollars, represented many millions less than the estimated $500 million to $1.5 billion Knoll might be liable for, while offering patients somewhere along the lines of $14 each. According to the Journal, the judge said that "the amount of fees sought suggests the possibility that the settlement is "driven by fees."

On December 10, 1998, Judge Bucklo held a status conference regarding the Synthroid litigation. The outcome? There is still no settlement for the Synthroid lawsuit.

The Court scheduled further proceedings in the litigation that will take place through October 1999. There is no trial date set. No money will be paid to any members of the class action unless the court actually certifies a class, and until the class obtains a judgement as a result of a trial, or a settlement is reached and agreed upon.

See Part II "Overpricing," with updated lawsuit information.

(Synthroid is a Trademark of Knoll Pharmaceuticals.)

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