Attorney General's News Release

July 29, 1999

Nixon obtains $1 million payment from pharmaceutical company that suppressed information from consumers

Jefferson City, Mo. — Attorney General Nixon today announced that his office has obtained a payment of $1,048,354 from Knoll Pharmaceutical Company and BASF Corporation to resolve concerns over the marketing of the thyroid hormone replacement drug Synthroid. Missouri's share is part of a $41.8 million nationwide settlement between Knoll and the Attorneys General of 37 states.

Nixon and the other Attorneys General alleged that Knoll had violated consumer protection laws in the ways it promoted use of Synthroid, which it manufactures and sells. Synthroid is the dominant and most expensive brand of levothyroxine sodium product on the market.

Levothyroxine sodium is a synthetic thyroid hormone replacement drug that is the common treatment for hypothyroidism, a medical condition in which a person's thyroid gland does not produce sufficient thyroid hormone. More than eight million patients in the United States take levothyroxine sodium daily.

Among the concerns raised by the Attorneys General were that Knoll:

• Attempted to prevent the publication of a study which showed that Synthroid and some less expensive generic levothyroxine sodium products were bioequivalent, meaning that for many patients the less expensive option would work just as well;
• Made deceptive claims that Synthroid was a reference product or the standard for levothyroxine sodium products;
• Made deceptive claims that no other competing brand was equivalent to or useful in place of Synthroid.

The Attorney General's Office will use the payment to cover the costs of the investigation and to pay for future consumer education and investigative efforts. In addition to the payment, the settlement requires that Knoll not make any false, misleading or deceptive claim regarding Synthroid or any other levothyroxine sodium product in advertising, promotion or labeling regarding its quality, reliability, safety, superiority, bioequivalence with any other drug or any other aspect of the drug.

Nixon pointed out that the safety or efficacy of Synthroid or any other thyroid hormone replacement product was not at issue, and that individuals who are currently taking the product should not stop taking it because of today's announcement. He further cautioned that individuals who use the product should continue their current medically recommended regimen and that they should discuss any questions they may have with their health care professional.

Joining Nixon in reaching the settlement were the Attorneys General of Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia and Wisconsin.

Inquiries from consumers should be directed to consumer@ago.mo.gov or 1-800-392-8222 (from within Missouri) or 573-751-3321 (outside Missouri).

All media inquiries should be directed to Press Secretary John Fougere.

E-mail      Phone: 573-751-8844         Fax: 573-751-5818