Cancer risks with arthritis drugs

[Guest guest]

Didn't notice if anyone posted about this. In my local paper today:

Cancer Risks Detailed for Arthritis Drugs

By LINDSEY TANNER

AP Medical Writer

May 16, 2006, 8:18 PM EDT

CHICAGO -- 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. 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. 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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On the Net:

JAMA: http://jama.ama-assn.org

Arthritis Foundation: http://www.arthritis.org