Shire Pharmaceuticals (acquired by Takeda Pharmaceutical Company, Ltd in January 2019) is the only pharmaceutical company which manufactures Vyvanse. Vyvanse is at its core, an amphetamine and as such, can be highly addictive. It was initially used to treat ADHD.
But then after years of lobbying, on January 30, 2015, the FDA approved Vyvanse to treat binge eating disorder in adults.
And yet, it was a number of events leading up to January 30, 2015 that are particularly perplexing … and disconcerting.
In 2008, the United States Justice Department sued Shire. The allegations arose from two lawsuits; the first filed by a former Shire executive, the second filed by former Shire sales representatives. Both lawsuits were filed under the False Claims Act’s whistleblower provisions.
An attorney in these lawsuits stated that, “…a claim Shire made was saying their drug Vyvanse was non-abusable. That turned out not to be true. It turned out that kids could abuse the drugs, and were doing so.” The government contended that no study Shire conducted had concluded that Vyvanse was not abuseable, and, as an amphetamine product, the Vyvanse label included an FDA-mandated black box warning for its potential for misuse and abuse.
Finally, in September 2014, Shire reached a settlement with the Justice Department. The settlement included resolving allegations that Shire sales representatives made false and misleading statements about the efficacy and “abuseability” of Vyvanse to Medicaid committees and to individual physicians. Shire also purportedly made unsupported claims that Vyvanse would prevent car accidents, divorce, arrests and unemployment.
Shire also agreed to pay $56.5 million to settle these false marketing, whistleblower lawsuits.
Four months later, the FDA approved Vyvanse. And yet, there is more.
In the approximate 18 month period before gaining FDA approval, Shire donated $450,000 combined to the Binge Eating Disorder Association (“BEDA”) and the National Eating Disorders Association (“NEDA)” to fund “awareness activities.”
In 2014 alone, Shire made a $250,000 donation to NEDA.
And questions must be asked as to why, especially when one considers …
While Shire was negotiating to resolve the claims regarding its egregiously false marketing, it was paying both NEDA and BEDA to engage in marketing and thereby increase awareness for Vyvanse.
Even still, the money train for NEDA and Shire continued.
In 2015, Shire funded NEDA to the tune of $500,000.
In 2016, Shire made another $500,000 donation to NEDA.
In 2017, Shire increased its funding to NEDA to $950,000.
In 2018, Shire made another $950,000.00 donation to NEDA.
The amounts contributed in 2017 and 2018 constituted approximately 25% of NEDA’s annual gross operating budget.
Which begs the question, why would a multi-billion dollar pharmaceutical company, on the heels of paying a $56.5 million dollar settlement to the Department of Justice pay NEDA/BEDA large amounts of money to market a drug the FDA had not yet approved?
We know that our friends at the National Eating Disorder Association do not conduct scientific research into eating disorders.
We also know that our friends at the National Eating Disorder Association do not establish nor amend treatment guidelines let alone generally accepted treatment guidelines for eating disorders.
After its merger with the Binge Eating Disorder Association, our friends at the National Eating Disorder Association are centering binge eating disorder and bulimia nervosa. Binge eating disorder … the only eating disorder for which Vyvanse is indicated.
So, who financially benefitted? And what services were NEDA/BEDA required to perform for that money?
Certainly the adage, “Follow the money” has never been more enlightening.
The 2018 third quarter earnings report for Shire disclosed sales of Vyvanse of $595 million.
Fierce Pharma, an industry watchdog group, issued its latest special report findings on July 13, 2020. Takeda/Shire was included in the pharmaceutical companies being analyzed. Fierce Pharma estimated that sales of Vyvanse in 2019 alone was $2.55 billion.
Meanwhile, the recent United States Deloitte Economic Report indicated the mortality rate for eating disorders is worse than believed.
As for NEDA/BEDA, it was able to acquire office space in Midtown Manhattan. The lease for that office space was renewed in 2019 resulting in an annual, year-end rental rate of:
2020 – $324,732
2021 – $330,757
2022 – $337,517
2023 – $377,554
Funding from Shire/Takeda and other large donors allowed NEDA/BEDA to compensate their current officers, directors and key employees approximately $259,000 [pre-BEDA merger] It allowed NEDA/BEDA to pay “other” salaries and wages in the amount of $1,375,110. It allowed BEDA/NEDA to pay their lobbyist approximately $178,545. And their results?
If an organization is making significant breakthroughs in the area of research into this deadly disease, perhaps those numbers could be justified. If an organization was working with doctors and clinicians, attorneys and insurance executives to finally draft and incorporate generally accepted standards of care, again, perhaps those numbers could be justified. If an organization is successfully pursuing lobbying for bills which will result in millions of dollar in research so that we may better understand and treat this deadly disease, perhaps those numbers could be justified. If not?
In any event, in Part Two of this series, we shall investigate what BEDA/NEDA does, what their focus is, and the direction they appear to be going.