It was supposed to be a blockbuster drug, the first of its kind to treat people with type 2 diabetes, and Rezulin certainly was a blockbuster. With some 1.9 million patients using it, Rezulin brought in an estimated $1.7 billion for its distributor, Warner-Lambert.
But then came problems, and now a Worcester man is fighting for his life, and what he calls justice.
NewsCenter 5’s Liz Brunner reported that just four years ago, Richard Robichaud said, he was a happy, energetic man. But now, at age 49, he has been told he has only a short time to live.
“All of a sudden I blew up with fluid. They said ‘You’ve got cirrosis of the liver.’ And I said, ‘No, I don’t have that. I don’t drink,'” Robichaud said.
While he never drank, he did take Rezulin just after it came on the market, for about eight months. It was sold as a drug to help those with type 2 diabetes, an illness Robichaud had been managing for 20 years. Now, however, he’s worse off.
“It’s like a slow death. That’s just what it’s like, having this liver disease. Rezulin has poisoned Rich’s liver, so it’s like a slow death,” said his wife, Barbara Robichaud.
Rezulin was approved for use January of 1997, the first in a new class of drugs shown in studies to help people with Type 2 diabetes better respond to their own insulin.
But the drug quickly came under fire. By October 1997, one liver-related death had been reported. In the months that followed, the company, working with the U.S. Food and Drug Administration (news – web sites), issued four separate letters to doctors, warning of risks, and requiring regular tests be performed on patients who use the drug.
In December of that year, the drug was removed from shelves in Britian for safety reasons. But it took 26 months before it would be taken off the market in the United States. By that time, 63 patients had died of liver disesae.
“They sold a product that they knew would kill people, they knew would seriously injure people and they counted the beans and knew they would make billions of dollars even after they paid the lawsuits,” said attorney Robert Bonsignore.
A spokesman for the Pfizer company, which now owns Warner Lambert, says the approval process is different in Britain and it maintains that the drug was safe when used appropriately.
“The FDA was completely aware of the United Kingdom’s decision. The benefits of Rezulin clearly outweighed the risks,” said Bob Fauteux, a Pfizer spokesman
At the Joslin Center for Diabetes, the head of adult diabetes clinic agrees. Dr. Martin Abrahamson says Rezulin was an important advancement for many patients who were not being helped by other drugs. In the past, he has received money from Pfizer for unrelated work.
“If people followed the guidelines for liver testing, a 1-in-100,000 risk of developing a serious liver event is in fact extremely low and lower than many other drugs being used in widespread clinical practice,” said Abrahamson.
But Robichaud believes it was this drug that has brought his life to its final days. He is one of more than 5,600 people suing the makers of Rezulin. It could take three years before his case is heard, and given his condition, his attorney has filed for a speedy trial.
“I’d like to wake up one day and feel good. I don’t know what that’s like anymore. One day. Without being sick, without needing help out of bed,” said Richard Robichaud.
So far, four cases have been heard nationally. In two of them, the patients won. The drug maker prevailed in one and in the fourth, a settlement was reached.