Did "60 Minutes" mislead viewers about the drug Acthar on May 6, 2018?
CBS "60 Minutes" on May 6, 2018 aired a piece which was critical of the company Mallinckrodt in its handling of the drug Acthar, which drug comprises an adrenocorticotropic hormone. There has been some push-back, in part about the way "60 Minutes" suggested that Mallinckrodt bought out a company with a competing drug Synacthen, and then deep-sixed the drug. If it is true, as the push-back states, that -- Synacthen has never been approved by the FDA for use in the U.S. for any indication and it is not an alternative treatment for IS in the U.S. --, then "60 Minutes" has some explaining to do.
The StreetInsider quoted the Mallinckrodt website as to the "60 Minutes" segment which aired on 6 May 2018:
On Sunday, May 6, 2018 CBS' 60 Minutes aired a segment entitled “Why Does Your Prescription Cost So Much?”, or “The Rockford File”, centered on claims made in a lawsuit brought by the City of Rockford, Illinois, alleging among other things, wrongdoing by Mallinckrodt and other companies related to the price and distribution of one of Mallinckrodt’s prescription medications, H.P. Acthar Gel, in the United States.
Prior to its airing, we communicated extensively with the producer of the segment and provided 60 Minutes with detailed and factual responses to their questions. It is unfortunate that 60 Minutes did not provide a full, balanced counterpoint to the claims made about Mallinckrodt and H.P. Acthar Gel.
Also, within the StreetInsider piece:
Synacthen is not a generic competitor to H.P. Acthar Gel. While the two drugs may share mechanistic effects through the ACTH component, H.P. Acthar Gel is much more. H.P. Acthar Gel is a biologically derived corticotropin drug – not a steroid – and amongst its many components includes a 1-39 peptide chain, meaning it includes more than simply ACTH. Synacthen is a synthetic ACTH 24-peptide chain. The two products are very different drugs.
Mallinckrodt did not pursue commercialization of Synacthen for IS, as the barriers to completion were, in our view, virtually impossible to overcome.
Synacthen has never been approved by the FDA for use in the U.S. for any indication and it is not an alternative treatment for IS in the U.S.
In all the time that Synacthen has been commercially available in select foreign countries, it has never been commercialized in the U.S. and no owner of Synacthen (including the owner prior to Questcor) ever undertook U.S. development of the drug in IS or any other indication.
Even in Canada, where Synacthen is approved and used in certain indications, it is not approved for use in IS patients. In fact, in Canada, the label contains a warning against use in infants or children under 3 years old due to the product containing benzyl alcohol.
Mallinckrodt is developing the drug (MNK-1411) in an indication where there is both high unmet medical need and, if successful, potential for greatest impact for patients – Duchenne Muscular Dystrophy.
link: https://www.streetinsider.com/Corporate+News/Mallinckrodt+%28MNK%29+Provides+Facts+on+H.P.+Acthar+Gel+in+Resonse+to+CBS+60+Minutes/14151942.html
Although not mentioned in the "60 Minutes" piece, Acthar is used in dealing with exacerbations in multiple sclerosis. From the National MS website:
H.P. Acthar Gel is a highly purified preparation of adrenocorticotropic hormone (ACTH) in a gel that is designed to provide extended release of the ACTH following injection. ACTH stimulates the adrenal cortex gland to secrete cortisol, corticosterone, and aldosterone.
ACTH was approved in 1978 by the U.S. Food and Drug Administration (FDA) as a short-term treatment for acute exacerbations of MS. According to its FDA labeling, corticosteroids (such as methylprednisolone or dexamethasone) are considered the treatment of choice for acute exacerbations.
link: https://www.nationalmssociety.org/Treating-MS/Medications/H-P-Acthar%C2%AE
In this MS example, there are available alternatives to Acthar.
The StreetInsider quoted the Mallinckrodt website as to the "60 Minutes" segment which aired on 6 May 2018:
On Sunday, May 6, 2018 CBS' 60 Minutes aired a segment entitled “Why Does Your Prescription Cost So Much?”, or “The Rockford File”, centered on claims made in a lawsuit brought by the City of Rockford, Illinois, alleging among other things, wrongdoing by Mallinckrodt and other companies related to the price and distribution of one of Mallinckrodt’s prescription medications, H.P. Acthar Gel, in the United States.
Prior to its airing, we communicated extensively with the producer of the segment and provided 60 Minutes with detailed and factual responses to their questions. It is unfortunate that 60 Minutes did not provide a full, balanced counterpoint to the claims made about Mallinckrodt and H.P. Acthar Gel.
Also, within the StreetInsider piece:
Synacthen is not a generic competitor to H.P. Acthar Gel. While the two drugs may share mechanistic effects through the ACTH component, H.P. Acthar Gel is much more. H.P. Acthar Gel is a biologically derived corticotropin drug – not a steroid – and amongst its many components includes a 1-39 peptide chain, meaning it includes more than simply ACTH. Synacthen is a synthetic ACTH 24-peptide chain. The two products are very different drugs.
Mallinckrodt did not pursue commercialization of Synacthen for IS, as the barriers to completion were, in our view, virtually impossible to overcome.
Synacthen has never been approved by the FDA for use in the U.S. for any indication and it is not an alternative treatment for IS in the U.S.
In all the time that Synacthen has been commercially available in select foreign countries, it has never been commercialized in the U.S. and no owner of Synacthen (including the owner prior to Questcor) ever undertook U.S. development of the drug in IS or any other indication.
Even in Canada, where Synacthen is approved and used in certain indications, it is not approved for use in IS patients. In fact, in Canada, the label contains a warning against use in infants or children under 3 years old due to the product containing benzyl alcohol.
Mallinckrodt is developing the drug (MNK-1411) in an indication where there is both high unmet medical need and, if successful, potential for greatest impact for patients – Duchenne Muscular Dystrophy.
link: https://www.streetinsider.com/Corporate+News/Mallinckrodt+%28MNK%29+Provides+Facts+on+H.P.+Acthar+Gel+in+Resonse+to+CBS+60+Minutes/14151942.html
Although not mentioned in the "60 Minutes" piece, Acthar is used in dealing with exacerbations in multiple sclerosis. From the National MS website:
H.P. Acthar Gel is a highly purified preparation of adrenocorticotropic hormone (ACTH) in a gel that is designed to provide extended release of the ACTH following injection. ACTH stimulates the adrenal cortex gland to secrete cortisol, corticosterone, and aldosterone.
ACTH was approved in 1978 by the U.S. Food and Drug Administration (FDA) as a short-term treatment for acute exacerbations of MS. According to its FDA labeling, corticosteroids (such as methylprednisolone or dexamethasone) are considered the treatment of choice for acute exacerbations.
link: https://www.nationalmssociety.org/Treating-MS/Medications/H-P-Acthar%C2%AE
In this MS example, there are available alternatives to Acthar.
posted by Lawrence B. Ebert at 4:17 PM
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