Childhood Obesity News has been tracing the recent history of weight-loss drugs, of which Vyvanse is an example. A company called Shire paid $2.6 billion to acquire the Vyvanse patent. As someone once said, “A billion here, a billion there, and pretty soon you’re talking about real money.”
But they surely have recouped their investment by now. Vyvanse had been around for a while, as a treatment for ADHD (attention-deficit hyperactivity disorder). In all likelihood, someone accidentally noticed its helpfulness in another way, and spread the word about using it “off-label” to alleviate binge-eating disorder (BED).
While the algorithm for making such a guess must be very complicated, someone arrived at 2.8 million as the estimated number of Americans who have BED. So, when in 2013 the American Psychiatric Association recognized binge-eating disorder as an official disease, it was a like manna from heaven to Shire.
Vyvanse was christened the go-to (if not yet officially recognized) prescription for BED. For The New York Times, Katie Thomas collected background facts:
A spokeswoman for the F.D.A. said Vyvanse was granted priority approval because there was no other drug treatment available for the disorder…
And it did not ask an advisory committee to review the issue because Vyvanse is already sold as an A.D.H.D. drug and its safety profile is well known.
Easy-peasy! But wait, there’s more, as Thomas takes readers back to the year 2011, when the FDA charged Shire with improper promotion of Vyvanse, Adderall and other products. As its punishment, the company paid the government a settlement of $56.5 million. Within months, the government granted the company permission to sell Vyvanse to treat BED.
So a whole new market opened up, despite strenuous objections from some quarters, because just like lots of other pills that have since become disallowed, this one is basically amphetamine, and Thomas wrote a great article about the history of legal “speed.”
She describes a website whose connection with the company is not obvious. It exists to help people who think they have BED, by providing a symptom checklist and suggested lines of dialogue for talking with a doctor. One might even think that it encourages patients to pester their doctors into prescribing a potentially troublesome drug. The hints are also useful for anyone who just likes the effects of speed, and needs a convincing story to tell the doctor.
The marketing strategy for Vyvanse, like that of Adderall, sheds light on how pharmaceutical companies seek to influence the diagnosis and treatment of a medical condition — in an effort to make billions of dollars in sales — even in the face of concerns about potential dangers of a drug.
On the opposite side of the coin, a fear exists that drug companies will fight against the further development and repurposing of BCG, a vaccine that has been used for decades to prevent tuberculosis. It looks like it might also halt the development of type 1 diabetes, and even reverse the disease. This would be quite amazing, but it would cause the makers of insulin to suffer a loss of sales.
Permission for human testing has been granted, and the first study will be a five-year trial. If that goes well, it will still take many more years to discover if BCG is really capable of performing the expected miracle.
Your responses and feedback are welcome!
Source: “Shire, Maker of Binge-Eating Drug Vyvanse, First Marketed the Disease,” NYTimes.com, 02/24/15
Source: “FDA approves mid-stage trial of vaccine to reverse type 1 diabetes,” FoxNews.com, 06/08/15
Photo credit: Victor Casale via Visualhunt/CC BY