The Triumph And Trouble With The Immuno-Biologicals

Dr. David J. Holcombe
Dr. David J. Holcombe

Immuno-biologicals represent a new class of medications, used for a wide variety of conditions.  They modulate the body’s immune response in different ways to either enhance or reduce inflammation (thus their other name, “biological response modifiers”).  In a sense, they continue the tradition of older anti-inflammatory medication, the most famous of which is aspirin.  Traditionally, anti-inflammatory medications were classified into non-steroidal anti-inflammatories (or NSAIDS, including aspirin, ibuprofen, naproxen and others) and steroids (cortisone-like agents).  The latter have broad anti-inflammatory and immunosuppressive qualities, but also cause glucose intolerance, susceptibility to infection, bone loss and other unpleasant side effects.


With increased scientific understanding of the inflammatory process, there has been a proliferation of agents that target very specific steps in that complex cascade.  These immuno-biologicals have been approved and promoted for use in an astonishing array of diseases, including psoriasis, rheumatoid arthritis, Crohn’s Disease, ulcerative colitis, multiple sclerosis, many types of cancers (kidney, melanoma, leukemia, and lymphoma) as well as other evolving indications.


These diverse agents include interferons (that inhibit cell growth), interleukins (that stimulate the immune system), colony stimulating factors (that promote healthy cell growth), and monoclonal antibodies (that target immune cells or intracellular components of inflammation).  Their diversity of action all leads to biological response modulation.  Since they often dull the inflammatory response in some way, they can also predispose toward infections, notably tuberculosis.  Screening tests for TB must be performed before many of them can be administered.


Since these medications are “new and effective,” they are aggressively promoted in advertising to the general public (and to providers).  They represent a change in therapeutic choices for the practitioners, but also a marketing challenge to drug companies.  While effective, all of these new immune-biologics cost many times more than previous therapies.  Drug companies, anxious to recover research and development costs, market these medications aggressively to the general public.  This direct strategy (unlawful in almost all countries except the U.S. and New Zealand), encourages patients to consult with their physicians to receive the newest (and presumably best) therapy.  Whether it costs pennies a month, as with many older drugs, or thousands of dollars, as with new immune-biologicals, cost is generally glossed over (especially in public advertising). “Ask your doctor,” remains the mantra.


The old dilemma of cost vs. benefit ratios bubbles up to the surface once more.  For the insured individual, third party payers are often left to decide who should benefit and at what price.  Similar questions arise for chemotherapy (sometimes with immune-biologicals) whose impact on survival might be measured in weeks or months rather than in years.


Since the scientific name for many immune-biologicals ends in “-ab,” “-ib” or “-cept,” the general consumer can sometimes get a clue about this new class of medications.  Many patients must still often pay hefty co-pays on pharmaceuticals, so sticker shock might be added to your previous illnesses.  A candid conversation with an informed medical provider should take place.   Unfortunately, many, if not most, doctors remain woefully unaware of the true cost of treatments (as well as tests, procedures and hospitalizations), and marketers often avoid the subject entirely.


No other services besides medical costs have remained so opaque to patients and providers alike. Yet, financial considerations must remain at least a part of the decision-making process for individuals and institutions.  As an attending physician at Johns-Hopkins once told the residents, “You will never solve the national debt at the patient’s bedside.”  While true, being aware of the real cost of medical care, including immune-biologicals, can only enhance patient care.


Look for the “-ab,” “-ib,” or “-cept” ending on the scientific name of a drug and ask a few probing questions.  How is it given (oral or injection)?  Is it really better than older, cheaper medications?  If so, what will it cost and can I afford it?