Yes, I admit it, what I find interesting often seems sort of random. The outward manifestation of my thought processes appears as organized as the typical sock drawer, but bear with me. I am interested in the whole topic of “off-label” use of drugs and devices since so much of what we do in wound care ends up being officially “off-label” per the FDA. And I am interested in how the Delphi process works – because frankly, our field could be helped by performing several Delphi consensus projects. I suppose that is why I noticed this JAMA Dermatology article about a Delphi Consensus statement on the use of low dose oral Minoxidil for hair loss.
Even though it happened at least 30 years ago, I remember the patient vividly. She was an elderly lady with a devoted son who was determined to save her leg from an ischemia-related amputation. By the time I saw her, it was too late given the amount of tissue loss she had and the level of ischemic pain from which she suffered. I tried to dissuade him from pursuing an aggressive limb salvage attempt, given the fact she was largely bedridden for other reasons and was suffering greatly and given the fact that the options at the time had a high complication rate. But that’s a story for another day. What I noticed incidentally was her extraordinarily long eyelashes. This was long before the eyelash extension industry. I am to be excused for noticing this since she spent all of her consultation with her eyes closed. Her eyelashes were so long that I could not help but mention it to her son. He mentioned off-handedly that they started growing when she began taking Minoxidil for her blood pressure. Since the only way that I can have long eyelashes is to buy them, I was intrigued . It was the first time I had heard of this interesting side effect of a blood pressure drug – although it turns out that it was well known by the manufacturers and was being marketed for hair loss “off label” as early as 1988. Eventually a topical form came to market specifically for hair loss.
It has taken 36 years for a consensus statement to be developed about the possible use of oral Minoxidil for hair loss disorders. I think we should take note of this fact. Drug manufacturers have no monetary incentive to perform expensive prospective trials to evaluate new uses of old drugs since physicians can usually prescribe medications “off-label”. However, payers may block access to expensive drugs via pharmacy “benefit management plans” if the patient does not carry the diagnosis for which the drug is FDA approved. Whether a Delphi consensus statement can help with payment policy, I do not know. However, it’s possible that some Delphi consensus statements could help practitioners defend themselves against a few of the ridiculous reasons for payment denial by out-of-control MAC auditors. I confess I would be embarrassed to put out a Delphi consensus process around whether the correct treatment for dry gangrene is a dry dressing (instead of a moist dressing), or whether opening 2 out of 3 below-knee vessels is “inadequate revascularization.” The list of stupid reasons for payment denial is long, and many experts would be embarrassed to have their names associated with a consensus document worthy of a Monty Python skit. Nevertheless, we might still have to do it.
At any rate, the big news is that 43 hair loss specialist dermatologists from 12 countries have agreed that low-dose Minoxidil might be benefit in hair loss conditions, until “high-quality evidence-based data emerge.” (Which, after 4 decades of successful off-label use of Minoxidil for this purpose, is not likely to happen…)
–Caroline
Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos
The opinions, comments, and content expressed or implied in my statements are solely my own and do not necessarily reflect the position or views of Intellicure or any of the boards on which I serve.
I was in pharmaceutical sales in the early 90’s when doctors were still allowed to use their brains. Back then when discussing MOA and side effect profiles of medicines, doctors were always thinking of potential off label uses for patients who were not responding to other treatments. Honestly one person’s side effect is another person’s cure. Those days are past us but medicine was way more fulfilling back then.