The recent decision by the Supreme Court allowing the Federal Trade Commission (FTC) to sue
pharmaceutical companies for potential antitrust violations was of particular interest to me. The fact
that it hopefully will reduce drug costs by allowing generic medications to be marketed is important.
Several issues need to be considered.
During the early 1950s, I was approached by a representative of Armour Laboratories, a division of
the Armour meat-packing company, about a drug they had developed – adrenocorticotropic hormone
– derived from a pig’s pituitary gland. This hormone, ACTH, is produced and secreted by the anterior
pituitary gland and increases production and release of corticosteroids from the adrenal gland. It was
an important drug during that era because it predated the nascent corticosteroid drugs, including
prednisone, dexamethasone, etc. The drug was synthesized by Klaus Hoffman at the University of
Pittsburgh in 1960. Initially, it was used for infantile spasms, refractory nephrotic syndrome, and
refractory autoimmune diseases.
In my family practice, during the 1950s and 1960s, I prescribed ACTH gel selectively to treat
patients with multiple sclerosis, acute gout, and flare-ups of rheumatoid arthritis. ACTH gel became a
successful tool for my patients. For me, the purchase price for a 5mL vial varied from $4 to $10.
During the 1960s and 1970s, the drug became even more valuable for me. As my practice in head-
ache medicine grew, I would prescribe ACTH gel for the treatment of prolonged migraine and cluster
headache attacks. As newer corticosteroids were introduced, I would prescribe ACTH gel injections
in combination with another steroid to potentiate and imitate an earlier response to the therapy. Dur-
ing the 1990s, the price for a vial of ACTH gel increased to $50. Managed care companies denied
reimbursement for these injections, and I discontinued using it for my patients.
In June, 2013, Questcor Pharmaceuticals acquired the rights to the drug, Synacthen, from Novartis.
Synacthen is a synthetic fragment of the hormone in H.P. Acthar Gel – the drug I used in the 1960s
– and is sold in Europe but is not available for purchase in the U.S. Questcor’s acquisition prevented
the sale of Synacthen to a smaller, start-up company – Retrophin. When it acquired the rights to
H.P. Acthar Gel in 2001, the drugs was selling for about $40 per vial. In 2007, Questcor raised the
price from $1,650 to $23,000 per vial. Its current price is $28,000 per vial. By acquiring the rights to
Synacthen, Questcor has eliminated any competition. Retrophin had hoped to offer Acthar/Synacthen
at a few hundred dollars for a vial.
For me, several questions arose. Is a drug that received a patent in the 1950s, still have protection
under that patent? How can the price of a 5mL vial increase from $50 to $28,000?
The consumer will certainly be helped by this Supreme Court decision. Further deals between phar-
maceutical companies to keep generic drugs off the market should receive careful scrutiny by the FTC.
Continued vigilance should also be directed to the pricing of drugs – generic and non-generic – with
consideration of the cost of manufacturing.
Seymour Diamond, M.D.
Chicago, Illinois
www.headaches.org
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National Headache Foundation
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