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Monday, 8/25/97 Drug company agrees to pay $135 million to Synthroid users SETTLEMENT: Patients were unaware of effective, yet cheap alternatives

By Matt Grace Daily Bruin Contributor Seven years of academic imprisonment surrounded a study conducted by UC San Francisco, until media pressure compelled the study's sponsor to publish. Unfortunately, only 60 of the 8 million people affected by the news seem to care about those results. In a settlement reached Aug. 1, Knoll Pharmaceuticals agreed to pay up $135 million to settle more than 60 class action suits seeking monetary compensation for the suppression of research relevant to their thyroid condition. "Patients feel wronged by the pharmaceutical company for not disclosing public information and by engaging in false advertising," said Robert Wallner, a lawyer for one of the participating law firms in the settlement. "There are a number of lawsuits alleging that Knoll and various other companies have made misrepresentations," Wallner said. Knoll produces Synthroid, a synthetic hormone taken by patients with thyroid glands that do not function properly. Individuals with thyroid disease or ones surgically removed depend on the hormone to maintain a normal metabolism. Without daily supplements, the thyroid cannot produce enough hormones to maintain the necessary chemical balance in the body. As a result, individuals become sluggish and vulnerable to weight gain and increased cholesterol levels. Synthroid is the most commonly used synthetic hormone, garnering 85 percent of the market. Doctors have been prescribing Synthroid almost exclusively for the 8 million people in the United States with thyroid problems. As a result, people have been paying two or three times more for Synthroid than they would for generic alternatives. For seven years, Knoll suppressed knowledge that the the cheaper generic brands were equally as effective as Synthroid. Not only has this angered individuals taking the drug, but it has encouraged debate on the academic freedom associated with corporate sponsorship of university research. This has brought considerable negative press for Knoll, especially in light of the excessive costs it has placed on so many patients. "Everyone has been harmed, so the courts permit people to sue on behalf of a class of people," Wallner said. In order to avoid the enormous financial burdens associated with litigation, Knoll President Carter Eckert agreed to the settlement, according to a press release. "Knoll reached a tentative agreement with a coalition of plaintiffs," said Linda Mayer, director of communications for Knoll. Faced with the possibility of years of litigation, the company decided that the prudent thing to would be to settle, Mayer said. Through a series of intense negotiations between a plaintiff's counsel representing the individuals seeking redress and Knoll Pharmaceutical, a settlement was reached. This settlement, however, is subject to federal court approval. Knoll suppressed the research on the grounds that the alternatives were not bioequivalent. This means the drugs being compared do not have the same biological effects on an individual. In the study, conducted by Betty J. Dong, generic alternatives were proven to be equally as effective as the market leader Synthroid. Although this still does not guarantee that both versions of the drug will have identical results for a given patient, it gives the consulting physician the opportunity to decide the best treatment plan. "I feel pretty comfortable using other preparations," Dong said. "The majority of patients can use either preparation, but every physician and patient need to collaborate." Until now physicians have been prescribing Synthroid because it was thought to be the most effective treatment available. However, when patients have the option to use the generic alternatives, price does not seem to be an influencing factor. "Sometimes patients ask for the name brand because they do not trust the generics," explained Mitzi Krockover, an internist for the Iris Cantor - UCLA Women's Health Center. Individuals might like the particular color or shape of the brand name, said Irwin Kurland, an assistant professor of medicine. "If someone comes in and wants a brand-name drug, you give it to them, Kurland said." Dong's study appears to have fallen on deaf ears. Despite nearly four months since being published in the Journal of the American Medical Association, sales of Synthroid have remained the same, Mayer said. "The American public does not buy the conclusions of Betty Dong's study," Mayer said. The study has "showed no impact on the use of synthroid," Mayer added. Although it may still be too early to assess the impact of the study, Mayer still doubts the bioequivalence of Synthroid and its alternatives. "There is still no evidence that the generic versions are bioequivalent," Mayer emphasized. The entire scientific community, however, supports Dong's study. Furthermore, Kurland predicts the use of Synthroid will curb once insurance companies adjust to the shift in medical costs. "Ultimately, the most influencing factor affecting which drug patients use will come from the insurance companies," Kurland said, "They will go with the cheaper brand." Allan Kannar and Associates has offered a toll-free number for individuals wishing to participate in the settlement. The number is 1-800-582-3398. Visit these sites for more information about synthroid: Drug InfoNet Doctors' Answers to Frequently asked Questions - Synthroid Synthroid Marketing Litigation Synthroid®