Rheumatoid Arthritis Drug Side Effects: Tuberculosis? Death?





Aug. 17, 2001 (CBS Evening News) There are new concerns tonight 
about dangerous side effects associated with some drugs for 
rheumatoid arthritis. A Food and Drug Administration advisory panel 
has been considering the problem, and CBS News medical 
correspondent Elizabeth Kaledin has our report.



Ever since the rheumatoid arthritis drug Remicade hit the market, 
it came with a powerful warning: "Serious infections requiring 
hospitalization may occur . . ."



But now an FDA advisory panel is trying to decide if that caveat is 
strong enough in the wake of a growing list of problems associated 
with Remicade and its cousin, Enbrel.



Rheumatoid arthritis is an immune system malfunction in which 
cells that normally fight infection turn on the body--often attacking 
and destroying joints. Enbrel and Remicade work by protecting the 
joints from the body's own immune system.



Dr. Steven Abramson is on the FDA panel.



"These are immunosuppressant agents so you can get infections you 
might not otherwise have," says Abramson, who practices at the New 
York University Hospital for Joint Diseases.



In fact, reports obtained by CBS News show that dozens of people 
on these drugs have needed emergency hospital care. And more 
troubling, there have been 22 reported deaths of people taking Enbrel 
and 48 deaths of people taking Remicade.



The people who died were all taking other medications and had 
other illnesses, and the drug company says problems are well within 
normal range.



Leslie Garrison of Immunex says, "We've been very impressed with 
rare events happening but always at or below the rate in the general 
population."



It's a paradox for the FDA, which is also faced with glowing 
success stories from people like Heidi McIntyre, who says Enbrel has 
been nothing short of miraculous for her.



"I would say in 25 years there has not been a single drug that has 
touched my arthritis in a positive way except this one," says 
McIntyre. "It's given me a big part of my life back." 



Warning labels have already been changed five times, so the 
question of what to do with these drugs that have hurt some and 
helped many will be a difficult one for the FDA, which ended its 
meeting today taking no action.



Sidebar: The Tuberculosis Question



Despite a growing number of adverse events linked to Enbrel and 
Remicade, the FDA insists that these drugs are a safe bet. 



"Overall, the data still suggest a favorable risk-benefit ratio," 
proclaimed Jeffrey Siegel, MD, a medical reviewer for the FDA. 



But experts at the recent FDA hearing say that at least one problem 
stands out: An unsettling number of patients who have taken these 
drugs ended up with tuberculosis, a potentially fatal infection that 
can spread to others. 



Although both drugs are linked to this problem, the numbers appear 
worse for Remicade. As of August 16th, at least 92 Remicade users 
(mostly from Europe) had developed this infection since the drug 
was introduced. The rate of tuberculosis was roughly four times 
higher than what is generally seen in rheumatoid arthritis patients. 



Officials for the company that makes Remicade announced strict 
new warnings on the drug1s label and are encouraging doctors to 
offer skin tests to screen patients for underlying tuberculosis. 



"We have to get physicians to skin test," said Jerry Boscia, vice 
president of clinical research and development at Centocor. 



Experts on the advisory panel agreed that screening was an 
important first step but warned that it might not prevent the 
problem entirely. 



"If all of us in this room had tuberculosis, 15 to 30% would not 
test positive for it," said Joseph Keane, MD, a pulmonary specialist 
at Boston University School of Medicine. 



Still, the advisory board seemed impressed by how well the FDA 
was keeping track of any emerging problems.



"It1s reassuring that the system is working," said Abramson. 



--additional reporting by Eric Sabo