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 headache 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 . During 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 pharmaceutical 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
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