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Novel Therapies Create New Morbidity (Remicade, etc)

October 22, 2006

This past April, an Italian venue was chosen to host the Fourth International Meeting on Inflammatory Bowel Diseases.

One speaker, Dr. Eduard F. Stange titled his presentation "Novel Therapies Create new Morbidity." His lecture discussed the "Risk-Benefit ratio" of using anti-TNF drugs, specifically infliximab (Remicade). He criticized the industry as promoting the drug treatment as "immunomodulation" when in reality it was "immunosuppression" [bold added]. He went on to explain:

Therefore, it is not surprising that this treatment [Remicade] is associated with side effects, including severe infections such as tuberculosis, and opportunistic infections including listeriosis, histoplasmosis, and many others (published as case reports or in the large clinical trials). In addition, autoimmune diseases including lupus erythematodes or multiple sclerosis have been observed as sequelae to the medication. Also, lymphomas and various cancers have been found at varying intervals after starting the medication, although a causal relationship is difficult to prove. [bold added]

He also quoted a study showing the mortality rate to be between 2% and 2.8%:

Some fatalities in the relevant studies, including Accent I, prompted a more systematic study and in those, including the Mayo Clinic patients or the Stockholm-area patients, mortality ranged up to 2% to 2.8%, much of it related to severe infections.

In addition to the side effects and increased chance of death, Dr. Stange pointed out that drugs such as Remicade actually don't work that well:

Efficacy of these novel agents is limited and usually only in the range of 40% remission. These rates decline further in the long-term and after 1 year they often are in the unsatisfactory range of 20% to 30% of the initial population.

He concluded by saying:

Novel therapies are urgently needed in IBD, but they do create new morbidity, sometimes in an unacceptable fashion.

This was a polite way of saying that for the vast majority of people, the risks of drugs such as Remicade outweigh any benefits. This lecture appeared in a journal titled "Inflammatory Bowel Diseases"--it is published by the Crohn's & Colitis Foundation of America.

(source: Inflammatory Bowel Diseases. 4th International Meeting on Inflammatory Bowel Diseases On the Way to New Therapies: April 9-12, 2006, Capri, Italy. 12(2) Supplement 2:S13, April 2006. Stange, Eduard F.)