SPRINGFIELDAttorney General Lisa Madigan, along with the attorneys general of 29 other states, announced a settlement with Bayer Corporation to resolve allegations that the company failed to adequately warn physicians and consumers of potential adverse side effects of Baycol®.
In a complaint also filed along with the settlement agreement, Madigan alleged that Bayer Corporation failed to timely and adequately disclose to physicians and patients the increased risk of rhabdomyolysis as a result of the use of Baycol.
Baycol, a prescription, statin cholesterol-lowering drug, was approved by the U.S. Food and Drug Administration in 1997 as a safe and effective treatment for the reduction of elevated total and LDL cholesterol levels in some patients, when diet and other measures fail to lower cholesterol. All statins carry a known risk of rhabdomyolysis, which is a breakdown of the muscle fibers and release of the muscle fiber contents into circulation and can cause kidney damage. With Baycol, however, that risk turned out to be significantly higher than other statins, particularly at higher doses and when combined with another cholesterol-lowering drug, genfibrozil. As a result of this increased risk, Bayer voluntarily withdrew Baycol from the market in August 2001.
As part of this settlement, Bayer will make significant, ongoing changes in the way the company discloses critical information from clinical trials of new drugs. Bayer will post information about and the results of new clinical studies online through an online clinical trial registry. This clinical trial registry will give physicians, consumers and researchers access to more information about the efficacy of the drugs, type and severity of side effects, goals of treatment, and timing and reasons for termination of clinical trial studies. Bayer specifically will register all Non-Exploratory Phase II clinical trials and all Phase III and IV clinical trials on www.ClinicalTrials.gov at the time the studies are initiated. Bayer will post the results of all Phase II, III, and IV clinical trials on www.ClinicalStudyResults.org.
After a drug or treatment has shown initial promise (such as through animal studies), clinical trials are performed on human volunteers under controlled conditions. Phase II clinical trials test an experimental drug or treatment on a relatively small group of people (100-300) to determine the efficacy of the drug or treatment and to evaluate safety. In Phase III trials, the experimental drug or treatment is given to a large group of people (1,000 to 3,000) to confirm efficacy, monitor side effects, compare it to other treatments, and collect other relevant information. Phase IV trials are performed after a drug or treatment is on the market to gain additional information about risks, benefits, and optimal use.
The clinical trial provisions of this settlement are a critical development for physicians and, ultimately, for patients, Madigan said. This will ensure that physicians have open access to important information about the drugs and treatments they prescribe so that they can make well-informed choices for their patients.
Also as part of this settlement, Bayer will pay $8,000,000 to the states. Illinois will receive $200,000 of this payment for use to fund consumer education and enforcement of the consumer protection laws.
Joining Illinois in the settlement are: Arizona, Arkansas, California, Connecticut, Delaware, Florida, Idaho, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, Montana, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington and Wisconsin.
Assistant Attorney General Cassandra Karimi handled this case for Madigans Consumer Fraud Bureau in Springfield.
From the March 7-13, 2007, issue