Remicade/Humira Warning-article

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Charrlygrl

Posted Wednesday, May 17, 2006 12:22 PM

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Last Login: Thursday, July 31, 2008 12:36 PM
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Cancer Risks Detailed for Arthritis Drugs

By LINDSEY TANNER
AP Medical Writer

CHICAGO (AP) -- Rheumatoid arthritis patients taking Humira or Remicade
face triple the risk of developing several kinds of cancer and double
the risk of getting serious infections, a study led by the Mayo Clinic
found.

The analysis builds on previous reports about the risks associated with
Abbott Laboratories' Humira and Centocor's Remicade. But the earlier
research focused mostly on one kind of cancer - lymphoma - and
infections such as tuberculosis and pneumonia.

The new study found an apparent link to other cancers, too, including
skin, gastrointestinal, breast and lung tumors. It also quantifies the
risks and says high doses appear to be the riskiest.

While the drugs' packaging information mentions some of the risks, the
manufacturers said the new study does not prove that the medication is
at fault, and they said the research was flawed.

Study co-author Dr. Eric Matteson, a Mayo Clinic rheumatologist,
stressed the overall chances of developing cancer while using these
drugs is still small. The researchers also noted that the medications'
benefits include improving flexibility and range of movement, easing
pain and increasing life expectancy, which arthritis can shorten.

In addition, the researchers noted that the risks for individual
patients probably vary widely. Older, sicker people who have taken the
drugs for several years probably face the highest risks, they said.

Still, the researchers said patients should be made aware of the
dangers and told to seek medical help if they develop fevers, coughs or
other symptoms of infection. They should also be sure to undergo the
cancer screenings recommended for the general public, the researchers
said.

Their study appears in Wednesday's Journal of the American Medical
Association.

Matteson is working with Centocor in developing a new drug that works
similarly, and he and co-author Dr. Tim Bongartz have been paid
consultants to Abbott for unrelated work, but neither company funded
the study. The Mayo Foundation sponsored the research.

Rheumatoid arthritis affects more than 2 million Americans, and
involves a malfunctioning immune system that attacks joints throughout
the body, causing pain, deformities and disability.

Dr. John Klippel, president of the Arthritis Foundation, said the study
will probably not change doctors' minds, because scores of patients
have benefited from the drugs. Remicade was approved in 1998, Humira in
2002.

More than a half-million patients have been treated with the two
injectable drugs and a third similar medication, Enbrel, all of which
block production of a protein linked with inflammation.

Enbrel was not included in the study because it differs at the
molecular level, Matteson said. He said he is getting paid by Enbrel
marketers Wyeth and Amgen to do a similar analysis on Enbrel alone.

Matteson's ties to Centocor and his work on Enbrel were among several
omissions and errors included in disclosure statements that accompanied
the study in JAMA.

He said the omissions were "errors of oversight on my part" and that he
was not attempting to conceal anything. Matteson said he brought the
issues to JAMA's attention on Friday.

But in an unusual move, journal editors posted a correction Tuesday on
JAMA's Web site revealing that they have asked the Mayo Clinic College
of Medicine to investigate.

The editors cited "the nature and extensiveness of this incorrect and
incomplete reporting."

In a telphone interview Tuesday, Dr. Phil Fontanarosa, JAMA's executive
deputy editor, said that "journals are not in a position to conduct
full-scale, intense investigations when there are concerns. ... We ask
the institutions to help us in getting to the bottom of these sorts of
issues."

The researchers analyzed data from nine studies comparing Humira or
Remicade with placebos and pooled the results. There were 29 cancers in
3,493 patients who received at least one dose of either drug, compared
with three cancers in 1,512 patients on placebos.

Serious infections occurred in 126 patients on drugs and 26 on
placebos. They included pneumonia and cellulitis.

An Abbott spokesperson said the analysis "doesn't reflect all the data"
on Humira and said the studies were too short to sufficiently monitor
cancer incidence.

Tom Schaible, Centocor vice president of medical affairs, said most of
the analyzed studies used higher-than-recommended Remicade doses.
"There's clearly a favorable benefits-risks ratio" with recommended
doses, Schaible said.

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