| firechief 2005-01-27, 6:02 am |
| New Studies Add to Data That Put Arthritis
Drugs on Hot Seat
01-25-2005 4:22 AM
By LINDSEY TANNER
CHICAGO -- Merck & Co. forced one of its researchers to
remove her name from a study linking Vioxx to heart attacks,
then criticized the findings before ultimately pulling the
arthritis drug from the market last fall, two of the
scientist's colleagues said.
"Even after funding and agreeing with the design of the
study, Merck publicly discredited our findings," Drs. Daniel
Solomon and Jerry Avorn of Boston's Brigham and Women's
Hospital wrote in this week's Archives of Internal Medicine.
Merck spokeswoman Anita Larsen confirmed the company's
action, saying Merck believed the study's conclusions "were
not supported by the data." The incident came about six
months before another study prompted the drugmaker to
withdraw Vioxx.
The journal contains several studies about Vioxx and
Celebrex, the once popular and heavily promoted painkillers
advertised as stomach-friendly alternatives to aspirin. They
are under congressional and regulatory scrutiny.
One new report echoes previous data suggesting that in some
older patients the drugs might not offer as much protection
as thought against gastrointestinal problems. A separate
study suggests they have been over-prescribed, frequently to
patients at low risk for GI problems. And other research
supports evidence that Vioxx increases some patients' blood
pressure.
Vioxx was withdrawn Sept. 30 because of a study suggesting
it doubled the risk of heart attack and stroke. Celebrex
maker Pfizer Inc. halted its ads last month after a study
linked high doses with increased heart and stroke risks.
Both drugs are in a class called Cox-2 inhibitors. The
Archives reports, published Monday, come just weeks before
a Feb. 16-18 Food and Drug Administration meeting on the
safety of all Cox-2 drugs. Also Monday, the watchdog group
Public Citizen petitioned the FDA to immediately remove from
the market Celebrex and a related drug, Bextra, because of
the potential heart risks.
Critics contend Merck attempted for years to suppress Vioxx
risks found in numerous studies. The company maintains it
has acted responsibly. The incident, mentioned in previous
news reports, involved a Merck study of more than 50,000
patients age 65+ taking Vioxx, Celebrex, traditional pain-
killers or none of the drugs. The results, published last
year in the journal Circulation, showed Vioxx patients faced
a higher heart attack risk than the other groups.
When the results came in, "Merck required a co-author who
was an employee of the company to remove her name from the
article immediately prior to publication," Solomon and Avorn
said in an Archives editorial.
Solomon identified the co-author as Merck epidemiologist
Carolyn Cannuscio. She did not respond to e-mail and
telephone requests for comment.
Larsen said publication policies at Circulation and Merck
allowed the drugmaker to remove the employee's name "if
the authors draw conclusions that are not supported by the
data." She said Cannuscio agreed with Merck's decision.
Meanwhile, the British medical journal Lancet is releasing a
study on the heart dangers of Vioxx after withholding the report
because the researcher said he had been threatened by his
superiors at the FDA.
The study links Vioxx to between 88,000 and 140,000 excess
cases of heart disease in the United States _ a conclusion
that has previously been disclosed.
Dr. David Graham, who works in the FDA's office of drug
safety, claimed he was threatened with dismissal and said he
asked the Lancet to withdraw the paper from publication in
November.
Earlier this month, the FDA agreed the study could be
published.
___
On the Net:
Archives of Internal Medicine:
http://archinternmed.com
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