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.
1958
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.
1988
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.
1990
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.
1990-1995
From 1990 to 1995, German-based BASF Corp. was in process of
acquiring Boots/Knoll Pharmaceutical operations.
1990-1995
During the same period, Boots/Knoll refused to consent to publication of
the Bioequivalence Study findings, claiming that the study has "gross
errors."
1995
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.
