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The Synthroid Settlement: Fair Payoff or Patient Ripoff?


Updated December 15, 2003

January 27, 1998 -- When I first heard about the publication of the manufacturer's efforts to block publication of the results of the Synthroid Bioequivalence study, I joined organizations such as Ralph Nader's Public Citizen in having concern that the American public was overpaying for a drug shown to be equivalent to less expensive versions of levothyroxine sodium. After publication of the study this past Spring, and the immediate filing of a class action lawsuit on behalf of patients, my concern only increased.

Why? Because no sooner than the lawsuit was filed a lawyer, who wished to remain anonymous, contacted me and indicated that he was fearful that the major class action lawfirm attorneys were being unusually quick to accept a possible deal being offered. The deal meant that the law firms would make millions, the manufacturer would pay far less than the original suit called for, and patients who'd overpaid for Synthroid? Well, they wouldn't get even enough money to buy one bottle of Synthroid when it was all over.

Currently, Synthroid is one of the top ten drugs sold in America, according to most pharmaceutical rankings, and is the #1 drug prescribed for thyroid disease. Synthroid is estimated to control 85% of the total market for levothyroxine sodium. With this sort of control of the market, and millions of patients paying money every month for their Synthroid, is the proposed settlement of the lawsuit fair to patients? First, let's take a look at the chronology and a summary of the issue.

In 1958, the drug Synthroid -- a brand name of the thyroid hormone levothyroxine sodium -- was introduced as the first synthetic thyroid drug. The F.D.A. approved it without asking for trial data, essentially leaving it unregulated. Levothyroxine sodium is used to treat hypothyroidism in people whose thyroid glands have been damaged by disease or have been surgically removed.

In 1988, a Synthroid Bioequivalence Study was commissioned by Boots/Knoll Pharmaceutical. The objective was to demonstrate that Synthroid was superior to competitive brands of levothyroxine sodium, and that competitors' products were not bioequivalent to Synthroid.

In 1990, the Synthroid Bioequivalence Study was completed. Results showed that Synthroid was not superior to the competitive brands of levothyroxine sodium, and the drugs were in fact bioequivalent.

From 1990 to 1995, German-based BASF Corp. was in process of acquiring Boots/Knoll Pharmaceutical operations.

During the same period, Boots/Knoll refused to consent to publication of the Bioequivalence Study findings, claiming that the study has "gross errors."

In 1995, BASF acquired Boots/Knoll Pharmaceutical operations for more than $1 billion, making Knoll Pharmaceutical Co., a Mount Olive, New Jersey-based subsidiary of BASF.

May 1996
In May 1996, Public Citizen's Health Research Group wrote FDA Commissioner David Kessler alleging that FDA regulations were preventing generic drug companies from making bioequivalent copies of the thyroid drug levothyroxine (Synthroid), and asking the agency to review safety and efficacy data on Synthroid as this product was basically unregulated.

April 1997
In April of 1997, the Journal of the American Medical Association (JAMA) published a study, commissioned by Knoll, that concluded that Synthroid -- a synthetic thyroid hormone -- is no better than two generic alternatives or the brand-name drug Levoxyl. Knoll disagreed with the study, and considered suing to stop its publication. Betty Dong, the researcher at the University of California at San Francisco who conducted the study, told the journal that Knoll had suppressed her findings for more than six years.

April 1997
Two weeks after the publication of the research findings, class action lawsuits were filed for $8.5 billion against Knoll and BASF in San Francisco, California on behalf of patients who purchased Synthroid during the period of January 1, 1990 to August 1, 1997. This is considered the period during which study results were allegedly suppressed.

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