Meridia Litigation
Good Morning America
March 27, 2002
Charley Gibson: This morning some serious questions over the popular obesity drug Meridia. Yesterday, the consumer advocacy group Public Citizen asked the FDA to take the drug off the market, and a class action suit was filed against the drug's maker after the deaths of thirty people who took the drug to lose weight.
Woman in Commercial:... has something which may help you lose weight. It's called Meridia..."
Charley Gibson: Meridia can help the seriously obese drop some of their weight.
Second Woman in Commercial: It can help you lose weight and keep it off.
Charley Gibson: Which is why more than eight million people worldwide have taken it. But, now there are questions about the drug's safety after the deaths of thirty people who took Meridia since it came on the market four years ago. The drug's maker, Abbott Laboratories, says there is no evidence the drug caused those deaths and noted that Meridia has been the subject of more than a hundred clinical studies of 12,000 patients worldwide. The controversy comes five years after the FDA pulled Fen-Phen off the market. Once considered the wonder drug of weight loss, it was blamed for seventy deaths. As for Meridia, the FDA stands by the drug's safety, but is investigating the new concerns.
Joining us this morning from Raleigh, North Carolina: Kathy Swizdor, whose husband died in August. He'd been taking Meridia for eight months. With me in the studio: Holly Cardwell, who says she developed a heart condition after taking Meridia. And also here is their attorney Ken Moll, who yesterday filed a class action suit against Meridia.
Let me start with you, Kathy. I know your husband died from a heart attack–51 years old, had been taking Meridia–but why, what evidence do you have that the drug might have been responsible?
Kathy Swizdor: Well I feel that he had been taking the drug, and in May–he died in August–and in May he had a real good report from the doctor, and at that time they raised the milligrams to 15 milligrams and a month, two and a half months later, my husband drops dead of a cardiac arrest.
Charley Gibson: He'd had some chest pains, I gather, and it does say on the warning label that chest pains can be a side effect from the drug. Did he check with the doctor about those chest pains?
Kathy Swizdor: At the time he didn't because he kept making up excuses for why the chest pains, like he had just eaten or something else, stress.
Charley Gibson: Ken Moll, let me turn to you. Cathy obviously suffered a great loss with her husband dying, but how can you contend that the drug was responsible? There have been dozens of clinical studies and, by definition, people who are taking Meridia are obese or very obese and therefore at high risk.
Ken Moll: Well, you have to realize that the studies that were supported to gain FDA approval, Abbott and Knoll Pharmaceutical's own studies, indicate that people taking this drug are gonna have an increased heart rate, increased blood pressure, and this is not what you want when you want to try to reduce these two problems.
Charley Gibson: Eight and a half million people have taken this drug. There have been thirty deaths, and I would think that that number... actually, you'd expect it to be higher in an obese population.
Ken Moll: But what you have to realize is the amount of deaths is much more than thirty. These are thirty reported deaths that went to the FDA. Our offices have received thousands of inquiries around the world from adverse effects from Meridia. Yesterday, we filed a class action, nationwide class action lawsuit to ask a judge to order the removal of this drug from the market. You have to realize, Meridia should have never been approved in the first place, and the Public Citizen Health Research Group...
Charley Gibson: It has been approved by the FDA. It's been approved in seventy different countries.
Ken Moll: Initially, it was five to four vote against its approval and what they did is, Abbott Laboratories and Knoll Pharmaceuticals funded studies to show the safety and efficacy of Meridia. This is a drug that the risks greatly outweigh its benefits. In its own study, they gave Meridia to certain patients and placebos to others. The people that took Meridia over a year only lost six and a half pounds more than the placebo people.
Charley Gibson: Holly, let me turn to you. You took it for five days and developed some problems.
Holly Cardwell: Yes. I was skipping beats in my heart. I went to the doctor. I've seen a cardiologist, and I have to take heart medication. I never suffered from any heart problems prior to taking this drug.
Charley Gibson: And you believe the drug is responsible?
Holly Cardwell: Absolutely, absolutely.
Charley Gibson: Nancy Snyderman, our medical correspondent, is joining us from out in San Francisco. I want to get what the sort of accepted medical community feeling is about this drug. Nancy, is it considered safe in the medical community?
Nancy Snyderman: Well, it's considered questionable, and I think it has been shrouded in controversy since it was approved. The real bugaboo is that pharmaceutical companies are now looking at obesity [as] a real health crisis in this country, and, there is no doubt about it, they are targeting doctors to treat obesity as a medical condition.
Charley Gibson: But, what advice do you give to people who may say, "Should I take this or not?" What...
Nancy Snyderman: Well, I think you raised a very good point, and that is: there have been thirty reported deaths in probably nine million prescriptions. Twenty thousand of those are written every week in the United States. It's a small number, but Americans have to get past the notion that they can eat whatever they want and take a pill to melt fat. They still have to be used with diet control. And yes, it causes health concerns–heart rate abnormalities, blood pressure abnormalities, and anybody who takes this pill and thinks it's gonna be a walk in the park is just fooling him or herself. Personally, I would look at other alternatives to lose weight before taking this medication, and if you take it, it has to be done with rigorous physician control.
Charley Gibson: Alright, Kathy Swizdor, I appreciate you joining us. Ken Moll, thank you very much. And Holly, thank you for being with us. We'll be back.