Wednesday, January 7, 2015

Does Do No Harm do harm? Food for thought.

Happy New year.  I recently joined an interesting call hosted by the MMRF for a few interested parties, where Dr. Lonial from Emory along with Dr. Daniel Auclairre of the MMRF spoke about the highlights from the ASH conference and took a few questions (some of which were from me).

One thing that struck me in hearing all these trials -- and in the philosophy of Dr. Lonial, who is quite an excellent doctor -- is that our entire medical system remains rooted in the concept of "First do no harm."  Incidentally, I was going to make a wisecrack about Hippocrates but it turns out this phrase originated not with the Hippocratic oath but with 19th century surgeon Thomas Inman.  Thank you, Wikipedia!

Anyhow, back to Myeloma.

A significant result of the "first do no harm" approach is that if you know treatment X is going to have more side effects than treatment Y, and you don't yet know if treatment X is going to be better than treatment Y, one is disinclined to pursue treatment X.  If you consider that the life-expectancy of a newly diagnosed patient is now 5+ years, that means that if we started today with a test of a lower side-effect therapy versus a higher side-effect therapy (Total Therapy qualifies, certainly) it would take much longer than 5 years before we knew enough to decide between the two types of treatments.  Conservatism will err on the the side of the treatment with fewer side effects.

This explains a lot, including the approach that Mayo and other conservative centers take with respect to treating the disease.

Interesting, at UAMS, this is turned somewhat on its head.  BB and Dr. GT, formerly at UAMS and then Huntsman and now in Iowa, have both told me on separate occasions that because they fervently believe that they approach cures a meaningful portion of patients while less aggressive approaches (to "standard risk" newly diagnosed disease) to not, that it would be a violation of medical ethics to put people into a trial that didn't offer then the same chance at a cure.  That "doing no harm" (in terms of not introducing side effects or any treatment related mortality whatsoever) in fact *does* do harm in the long run.

When you combine these two issues -- conservative centers that don't want to risk greater side effects with aggressive centers that believe it would be unethical to randomize into less effective trials -- it points out how challenging it will be to ever get a head-to-head trial to compare Total Therapy with something less aggressive.  And even if such a trial could be put together, it would take many years before results were known.

In other words: there will probably be a clear and definitive cure before there is a clear and definitive universal point of view on Total Therapy.   And until that time, patients will be required to do their own research, form their own opinion, and select a doctor whose philosophy and approach is compatible with their own belief set, comfort level, risk/reward preferences and other decision-making factors.

Some food for thought.