One of the controversies surrounding Acthar is that it doesn’t have any documented randomized clinical trials that support its effectiveness in any other indication aside from infantile spasms, which makes up only a small portion of its sales. It also happens to cost around $40,000 a vial. Though I’m not sure what articles provoked Mallinckrodt to feel the need to make a statement today, something obviously set them off tonight:
Recently, several articles have appeared that draw a number of erroneous conclusions about Mallinckrodt Pharmaceuticals and its product H.P. Acthar Gel based on misinformation and a variety of distorted and conflated facts. Mallinckrodt disagrees with these views and offers the following basic, but important facts about this critical medicine.
Very official sounding. You can read the whole fancy thing over at Mallinckrodt’s IR site.
But first a refresher on Acthar history:
Acthar, the drug in question, was approved by the FDA in 1952 – Harry Truman was president, the Dow Jones was at around 275 and Mickey Mantle had just hit his first career grand slam.
A lot has happened in those 64 years, including the development of synthesizing steroids like prednisone. These synthetics “became the treatment of choice” for the same health problems that Acthar was treating at the time. Acthar was actually discontinued in 1995, when the FDA found quality control problems at the factory manufacturing the drug, according to the New York Times. It was reported that Aventis then only manufactured the drug for a small group of patients that wanted it for infantile spasms. It was a money-losing drug that was made in limited supply for infantile spasms or acute MS exacerbations. Aventis helped Questcor set up facilities to produce the drug after they purchased it, according to the New York Times.
The company is correct in its press release when it says there’s randomized clinical trials supporting its effectiveness in infantile spasms:
The effectiveness of the drug as an IS treatment is supported by two randomized clinical trials, one of which compared H.P. Acthar Gel to prednisone, and is reflected in the IS clinical trial results that appear in Section 14 of the full prescribing information for the drug.
Infantile spasms are just one of the nineteen indications that Acthar is prescribed for, though.
The company then cites a bunch of official looking “articles” to back up its use in other indications. Presumably the company wants you to think these articles are something close to randomized clinical trials. They are nothing of the sort. They’re just subjective articles referencing an experience here and there. None of them are randomized clinical trials.
As QTR pointed out the last time I wrote about Mallinckrodt late last year, the company did recently run one “eight-week, double-blind, randomized placebo-controlled trial that assessed the clinical efficacy of repository corticotropin injection (RCI) in 38 patients with persistently active SLE involving skin and/or joints despite moderate dose corticosteroids” in 2015.
The study failed to meet its primary endpoint.
But, as QTR stated in September, that hasn’t stopped Mallinckrodt from aggressively continuing to market Acthar for Lupus flares and maintenance, among more than 15 other indications.
So, this press release clears up nothing. Zero. Zip. Nada.
Does Mallinckrodt think we are all morons? I may be, but that’s beside the point.