Acthar linked with Hospitalizations, Deaths

Acthar has been linked with hospitalizations and deaths at a rising rate. Adverse events from Acthar spiked in 2016. FDA data shows that hospitalizations tripled, while “other serious” Acthar side effects quadrupled. Those injuries and a hardball sales push for off-label use have triggered a whistleblower lawsuit against Acthar’s maker, Mallinckrodt Pharmaceuticals.

Acthat Whistleblower Lawsuit
A former Mallinckrodt sales rep has filed a whistleblower lawsuit against the company. The former employee says he was pushed to promote Acthar for off-label uses. Meanwhile, a neurologist who has studied Acthar says the spike in hospitalizations could indicate that it is being overused.

Acthar Blockbuster Drug
Acthar may be the primary reason that Mallinckrodt Pharmaceuticals has triggered a big run of short selling on Wall Street. Word on the street is that Acthar is oversold, and it doesn’t work in off-label uses for which the whistleblower says it was pushed by the company. Off-label Acthar use may be killing elderly people.

Acthar Off-label Use Under Fire
Stock traders who are profiting from Mallinckrodt’s stock decline have questioned Acthar’s efficacy. They also question Mallinckrodt’s dependence on deals with pharmaceutical middlemen for expanding Acthar use. They question why a drug primarily indicated as a treatment for infants has morphed into a massive expense for Medicare, a program for the elderly.

FDA: Acthar linked with Hospitalizations, Deaths
BusinessInsider.com reports that Acthar critics now have a new line of attack. U.S. FDA data shows adverse event reports for Acthar users have recently spiked. Acthar has triggered everything from hospitalizations to death. That increase has far outpaced prescription rates.

Andrew Left of Citron Research jumped on the data. Mr. Left released a report June 22, 2017 that said Citron “believes the reason for the increase in adverse events is the company’s expansion of Acthar into new indications where it has not conducted clinical trials in order to test its safety in new indications.”

Mr. Left is not the only short seller targeting Mallinckrodt. Company shares tumbled in early trading on June 22 before regaining their losses.

9,000 Acthar Users
Roughly 9,000 people now take Acthar, according to Mallinckrodt.

Acthar Deaths Rising
Eighty-two deaths were reported in 2016, 69 in 2015. Hospitalizations nearly doubled to 427. Other serious side effects quadrupled to 436.

Mallinckrodt Response
Mallinckrodt released a statement saying that side effects linked to Acthar were often relatively minor. The company said that correlation of Acthar side effects didn’t necessarily mean causation.

Acthar Problems – Uses Not FDA Approved
The data does show Mallinckrodt’s strategy of taking an old drug that never went through the rigors of FDA approval and trying to expand its use could be causing the company problems. Mallinckrodt has turned Acthar into a drug with over $1 billion in annual sales. It has done so by persuading doctors to prescribe it even to the sickest patients, even when there are much cheaper alternatives.

Acthar Overuse Triggering Side Effects
Dr. Dennis Bourdette, the chair of neurology at the Oregon Health & Science University, said the spike in adverse events could be a sign the drug is being overused in a way that is triggering side effects.

“Some doctors are using Acthar like an ongoing, monthly, or weekly therapy over long periods of time, and when you do that there are all sorts of side effects that can occur because of the steroid effects that can occur,” said Dr. Bourdette.

Acthar Acts Like Steroid
Acthar’s website shows the company claiming Acthar is not a steroid, even though its effects are similar. The site says Acthar “works by helping your body produce its own natural steroid hormones.” Dr. Bourdette says the explanation doesn’t matter, because Acthar still acts like a steroid. ” said Dr. ACTH is having all these effects on the immune system apart from releasing cortisol,” Bourdette, referring to the adrenocorticotropic hormone in Acthar.

“When your body produces too much cortisol you’re going to have chronic steroid side effects we’ve known about for decades, and every doctor is trained in those side effects.”

Acthar Designed for Infants, not Geriatrics
Acthar is supposed to be taken for about five to 15 days to treat infantile spasms and multiple sclerosis. At the same time, there’s no specification on dosage for the 17 other conditions that Mallinckrodt says can be treated with Acthar.

Acthar was grandfathered into FDA approval because it dates back to the 1950s before clinical testing was required. Consequently, some have questioned its efficacy.

Mallinckrodt Defense?
Mallinckrodt has said repeatedly that only the most desperate patients should take Acthar. Publically, the company suggests it’s not the primary treatment for many of the ailments it is used against. Thee company says Acthar is used only after other drugs don’t work. But is that what they tell their drug salesmen, and the doctors to whom they’ve marketed the drug off label?

Mallinckrodt’s web site admits the company doesn’t know “the exact way that Acthar works in the body” and says “further studies are being conducted.” It also says that some information on the website “is based on laboratory data, and how it relates to patient benefit is unknown.”

Acthar Whistleblower Lawsuit
Why would doctors prescribe too much Acthar for the wrong ailments? We may find out from a whistleblower lawsuit. In December 2016, a former Acthar sales rep, Barry Franks, filed a whistle-blower lawsuit against Mallinckrodt.

Mr. Franks’ lawsuit accuses the company of pushing him to promote Acthar’s use for off-label indications. He said his bonus depended on off-label promotions. He says that he was fired because he wouldn’t do things Mallinckrodt’s way.

The complaints states that Mr. Franks, “alleges that there were illegal sales practices being committed in other regions, and that Mallinckrodt used these regions as the gold standard or basis Incentive Bonus Plans for which all regions were compared and asked to duplicate. Franks was expected to deliver sales that were not supported by lawful practices.

“Franks was also aware of other compliance related issues at Mallinckrodt, which Franks … alleges that these issues include but were not limited to: potential insurance/Medicare fraud … HIPPA violations where four or eight week prescriptions were provided where there was no patient visit and violations where Mallinckrodt permitted, for a certain period of time, certain employees to manipulate the compensation plan by having physicians wrote shorter prescriptions that were refilled, to earn a bonus on the patient at the shortest prescription interval.

“(Shorter prescriptions did not allow sufficient time to see if a patient responded to the drug. In some cases the drug was shipped the same day as the referral was received. This was done to ‘game the system’ and potentially commit insurance/Medicare fraud.)”

Acthar linked with Hospitalizations, Deaths

Mallinckrodt did not respond to a journalist’s request for comment on Franks’ claims.

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