No Rezulin, No Easy Transitions for Patients
Now that Rezulin has been yanked from the U.S. market, James Glenn Helm is surprised by his own ambivalence.
The 58-year-old graphic artist stewed for months, concerned about reports that the popular pill prescribed for his type 2 diabetes might severely, even fatally, damage his liver. But his physician, calling Rezulin “state of the art,” gave short shrift to his patient’s qualms.
Helm knows that the withdrawal of Rezulin leaves his doctor with no choice but to respect his wishes. Yet his dwindling cache--just 14 pills--leaves him fearing a return of diabetes’ hallmark sapped energy and unslakable thirst. What if he cannot find a substitute before his supply runs out?
Just as confusion has marked the response of many patients to the increasing controversy over Rezulin, confusion dominated the mixed emotions Wednesday over its removal as an option.
From Helm’s hometown of Mesquite, Texas, and Jackson, Mo., across the country to Southern California, patients and doctors mulled their options and rehashed the Rezulin debate: “It’s been a wonder drug.” “Rezulin is a dangerous drug.” “The alternatives are very good.” “We will still have to monitor the liver.”
Even the most expert of experts must puzzle their way through the transition. Dozens of physicians calling the American Diabetes Assn. for guidance were being asked to phone back some other time. The group’s Web site contained merely the promise of an upcoming statement.
“We are working to provide answers but we were blindsided by this,” said association spokeswoman Bernadette King.
Pharmacists pulled Rezulin off shelves coast to coast, without waiting for memos from corporate headquarters. Meanwhile, the Food and Drug Administration and Rezulin’s manufacturer, Warner-Lambert Co., advised patients to call their doctors before discontinuing the medicine.
About 300,000 Rezulin prescriptions were written last month.
Diabetics make up the overwhelming majority of Rezulin users. Some women suffering from a disorder that produces too much insulin and extra testosterone also take the drug to restore normal female hormone levels, although this use is not recommended by the manufacturer or the FDA.
The FDA has concluded that Rezulin use “possibly or probably” resulted in 90 liver failures, including 63 deaths.
“I curse the FDA,” said Michaela Wirtz, 35, of Waukesha, Wis., who credits Rezulin for suppressing testosterone levels--with no side effects. “I’ve often said they’d have to pry my Rez from my cold, dead hand.”
But relatives of Rezulin users who died said that the action came too late. “I am pleased that it was pulled so it won’t kill anyone else,” said David Rice, a Battle Creek, Mich., teacher whose 78-year-old father suffered fatal liver failure in 1998.
“But I don’t think that it is right that the FDA approved this in the first place when some of their scientists were saying, ‘Let’s slow down on this,’ ” Rice added, audibly struggling to fight off tears.
Doctors, too, are divided in their reactions.
The withdrawal “is intellectually satisfying,” said Dr. Fred Ziel, who chairs the endocrinology committee for Kaiser Permanente in Southern California. In February, the health maintenance organization said that it would no longer pay for Rezulin. Kaiser is converting patients to Actos, a similar drug.
Dr. David E. Aftergood, a Los Angeles endocrinologist, felt differently. He blamed overheated politics and sensationalist reporting for the FDA’s action. “Personally, I’m comfortable using it,” he said. “I’ve had people on the drug for three years.”
He tests his patients’ liver function monthly when they begin the regimen. Three times, he said, he found elevated liver enzymes in patients, promptly stopped their Rezulin and the condition cleared up.
The FDA withdrawal sobered some fierce Rezulin partisans. Vincent Tampio, who heads the scenery painting section at CBS studios in Los Angeles, thought that the first media reports were overblown. At 65, he has lived with diabetes for 15 years, the last three on Rezulin.
He had started by adjusting his diet. Then he took pills and more pills and more pills. He was not sleeping well at night. He was fatigued during the day.
He said Rezulin helped him bounce back.
But Wednesday he said: “If it’s bad for other people, it could be bad for me.”
His main concern now, he said, is the cost of the two drugs similar to Rezulin, Avandia and Actos. The December 1999 Red Book, a quarterly report on average wholesale drug prices, said that Rezulin cost $3.86 per day, while Avandia costs $4.40 per day and Actos $4.56 per day.
Trudy Garland, a church secretary from Jackson, Mo., is worried about the alternatives too, but for a different reason.
She worries that they, too, carry side effects.
She never had liver problems on Rezulin, but whenever she walked, a shooting pain in her back made her wince.
Others on the drug have reported similar complaints, though doctors said that these are not common reactions.
Garland carried a lawn chair with her whenever she left her house, so she could rest every half block or so. She tried another, more traditional diabetic medication for about six months. Her doctor wanted to try Rezulin again.
The pain came back.
She tried Avandia. The pain came back.
She is now taking Actos. The pain is back.
Times researchers John Beckham in Chicago and Janet Lundblad in Los Angeles contributed to this story.
