FDA charges Merck



Regulators allege Merck misled doctors on cardiovascular safety of 
Vioxx

September 24, 2001


http://cnnfn.cnn.com/2001/09/24/news/wires/merck_re/



          

NEW YORK (Reuters) - U.S. regulators have charged drug company 
Merck and Co. Inc. with misleading doctors about its blockbuster 
painkiller Vioxx with promotions that downplayed a possible risk of 
heart attacks.



In a warning letter sent Sept. 17 and released publicly late Friday, 
the Food and Drug Administration ordered the company to stop using 
some promotional materials and to send a letter to healthcare 
providers to correct any false impressions.



The regulatory agency took issue with statements made during 
company-sponsored audio conferences, in a May 22 press release and 
by sales representatives at two medical meetings.



The FDA said the promotions minimized results of a trial that 
showed a higher rate of heart attacks among people treated with 
Vioxx compared with another pain reliever, naproxen.



 	 

Additionally, the FDA said Merck's materials downplayed a 
potentially dangerous interaction between Vioxx and anti-clotting 
drug Coumadin, known generically as warfarin.



"Your minimizing these potential risks and misrepresenting the 
safety profile for Vioxx raise significant public health and safety 
concerns," wrote Thomas Abrams, head of the FDA division of drug 
marketing, advertising and communications.



The mischaracterizations of Vioxx's safety were "particularly 
troublesome" because the FDA had warned the company about it in a 
previous letter, Abrams said.



Merck also made unsubstantiated claims that Vioxx was safer than 
other non-steroidal anti-inflammatory drugs, the FDA said. In 
addition, the company promoted Vioxx for unapproved uses such as 
relieving rheumatoid arthritis, preventing cancer and treating 
Alzheimer's disease and gout, the FDA letter said.



Vioxx is battling with Pharmacia Corp.'s (PHA: Research, 
Estimates) Celebrex in a multibillion dollar market to ease pain 
from arthritis. The drugs are known as COX-2 inhibitors.



A review of studies on the drugs, published in August, said both 
may carry a risk of blood clots that lead to heart attacks. Both 
makers disputed the findings.



According to the FDA letter, a doctor hired by Merck (MRK: 
Research, Estimates) argued during an audio conference that 
naproxen, the generic painkiller that Vioxx was compared to in a 
large trial, protected the heart, which explained why naproxen 
patients had fewer heart attacks than Vioxx patients. The FDA said 
that reasoning was "hypothetical."



Merck spokeswoman Christine Fanelle said the company was 
developing a response to the FDA that it planned to submit by Oct. 1. 
"We continue to stand behind the overall safety and cardiovascular 
safety of Vioxx," Fanelle said.



The FDA sends hundreds of warning letters a year. Most issues 
raised in the letters are resolved without further regulatory action.