Drug company agrees to pay $135 million to Synthroid users

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®