Drug Maker Wants Rezulin Review
Warner-Lambert, the manufacturer of the diabetes drug Rezulin, is asking the Food and Drug Administration to investigate allegations reported Thursday night on the CBS Evening News.
In the report, CBS News Correspondent Sharyl Attkisson recounted allegations from a clinical investigator, Dr. Janet McGill of Washington University in St. Louis.
McGill said that in 1994, when she was the principal researcher on a study of Rezulin sponsored by Warner Lambert, she got a personal visit from two Warner-Lambert officials when she reported that two of her twenty patients taking Rezulin developed liver problems.
McGill claims the Warner-Lambert officials pressured her into downplaying the problems.
She told CBS News the company also failed to properly report those liver problems in summary data it submitted to FDA to get Rezulin approved.
Also Friday, Warner-Lambert formally requested that the FDA schedule a public meeting of its Advisory Committee on Endocrinologic and Metablic Drugs in July to discuss the safety facts regarding Rezulin and other drugs in the same chemical class.
Rezulin went on the market in 1997. As the Los Angeles Times first reported, there have been at least 85 cases of liver failure, 58 of those resulting in death, since then.
McGill told CBS news the mounting death count prompted her to speak out.
Declining to be interviewed on camera, McGill has written the FDA and Congress saying "It's time to consider taking action against a company that puts profits before the lives of patients with diabetes."
CBS News has also learned that the doctor in charge of testing the drug for the federal Food and Drug Administration now also wants Rezulin pulled from pharmacists' shelves.
Dr. Robert Misbin, the FDA doctor in charge of Rezulin reviews, has also taken the unusual step of writing to Congress.
"I have been frustrated in my efforts to convince my superiors that the time has come to remove Rezulin from the market,"Misbin wrote.
| Warner Lambert issued this statement on March 10: CBS Evening News and other media sources have reported that a clinical investigator, Dr. Janet McGill of Washington University in St. Louis, alleged in a letter to Dr. Robert Misbin of the U.S. Food and Drug Administration that information regarding two patients in a clinical study sponsored by Warner-Lambert was not reported to the FDA. Documents submitted to the FDA confirm that allegations in her letter are inaccurate. Nevertheless, given the serious nature of these allegations, it is imperative that the FDA conduct an objective review of the scientific facts. Warner-Lambert will request that the agency conduct this review as soon as possible and that the results of the review be made public. |
Once a supporter of Rezulin, Misbin says there are now other, safer drugs available.
However, the official FDA position is that Rezulin is still safe and effective.
Rep. George Nethercutt, R-Wash., chairman of the Congressional Diabetes Caucus, is one of the congressmen investigating Dr. Misbin's claims.
"Any doctor or investigator of that stature certainly gets my attention, and I think it deserves attention to make sure we're doing what's right for the public," Nethercutt said.
In response to inquiries from CBS News, Warner Lambert said, "Dr. McGill's letter contains a number of inaccurate allegations and we will correspond directly with the FDA regarding the inaccuracies...We are confident we have submitted all required data...to the FDA."
Rezulin is used in combination with insulin or other drugs to treat type 2 diabetes.
By November 1997, the FDA and the manufacturer announced changes in how Rezulin should be prescribed information FDA, citing "approximately 35 post-marketing reports of liver injury" in the U.S. and Japan.
In December 1997, the FDA announced stricter rules for montitoring patients on Rezulin. Those recommendations were strengthened in July, 1998.
Among the alleged Rezulin victims was Monica George, profiled in a CBS News report last month.
Rezulin is used when insulin can't adequately control blood glucose levels.
Type 2 diabetes is a life-threatening disease that affects 18 million Americans and is a leading cause of coronary heart disease, blindness, kidney failure, and limb amputation.
Click here to see Rezulin: A Chronology.