While the coffee wasn’t quite ready this morning, I ventured to the Wall Street Journal health page at the Wall Street Journal, one of my frequent first-reads.
I was immediately intrigued by a short article from the excellent Jennifer Corbett Dooren about Roche-Genentech gaining US FDA approval for a new rheumatoid arthritis drug, Actemra.
Actemra (tocilizumab) is a monoclonal antibody that works via a novel mechanism of blocking the receptor for interleukin-6, a pro-inflammatory molecule called a cytokine. What is most important is that Actemra appears to work in patients who have not been helped by other existing drugs such as those like Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab) that block the effects of another cytokine called TNF-alpha.
Rheumatoid arthritis is not just joint aches and pains. It is a very serious disease that can cause not just pain but deformity and progressive disability. Rheumatoid arthritis afflicts 1.3 million people in the US.
But what caught my eye and generated my pre-caffeine ire was in the opening sentence, terminology used in clinical pharmacology and therapeutics, words that I admit to have even uttered myself:
WASHINGTON–The Food and Drug Administration Friday approved a new type of drug by Roche Holding AG’s Genentech unit to treat rheumatoid arthritis in patients who have failed other treatments. [emphasis mine]
I know that we use that phrase because it is seems less cumbersome than saying, “in patients whose disease has not responded to existing drugs.”
But saying that the patient failed the treatment makes it seems that the patient somehow bears responsibility for the lack of their disease to respond to the tools we currently have available. Yes, yes, I know – disease is essentially a patient’s own pathophysiology, where their own homeostatic mechanisms are awry or respond inappropriately to environmental changes or invading organisms.
But jeez, have you ever thought what it sounds like to a patient to hear that they failed the therapy? Could we possibly take any less responsibility for our failure to treat disease? Even if physicians want to use the word “fail” couldn’t they at least shift the blame to us basic scientists who’ve failed to come up with an alternative drug?
As I’m writing this and searching for literature on the medical psychology of using this term, I just realized why I am bothered. If we accept that medicine says, “the patient failed the treatment,” that’s one thing. What troubles me is that I just read the statement in the opening sentence of an article in a highly-regarded business publication crafted by a health and medicine writer whom I respect.
Don’t get me wrong. I’m all for personal responsibility in health. All of us could do a better job of watching what we eat, exercising more, not smoking, drinking alcohol in moderation – the big four factors that could make a greater impact on human disease than the next new wonder drug.
But just because a $10,000/year drug doesn’t work for me and my rheumatoid arthritis, does that really mean that “I failed the treatment?”
I know we’ve got some medical sociologists and psychologists out there reading – I’d be grateful for any commentary or direction to scholarly literature on why we continue to use the term, “the patient failed the treatment.”
One final note
As an amorphous descriptor, Big Pharma has certainly lost a lot of trust of the general public and the scientific community over the past several years from data cover-ups on drug-related deaths to ghostwriting of peer-reviewed journal articles, the latter of which was eloquently addressed by Orac last year. These practices are inexcusable and deserve strong punishment, especially where it is clear that loss of lives was a result of deceptive clinical data submission.
I’ve had the pleasure of training with many outstanding scientists who now work in the industry and, particularly in the field of pharmacology, have come to respect and learn from new colleagues who’ve chosen industrial careers. Several of these people are among the most ethical I know and, as with any other industry, are pained equally if not more by the scandalous cases.
So when good things happen, such as the approval of a new drug that has the potential to help people in pain for whom no other agent has helped, I like to acknowledge the efforts of those folks behind the work.
Let me offer my heartiest congratulations to colleagues at Roche and Genentech on this nail biter after having been asked for more data last year. Addressing these kinds of scientific and regulatory challenges gives me great respect for my colleagues at the bench and in the clinic who have worked to relieve human suffering from this debilitating disease.