Tuesday, June 7, 2016

Marketing Methamphetamine Clones for Fun and Profit

From 2010 (when I first started this blog) until 2013, I published several posts about the United States Department of Justice assessing huge fines against several large pharmaceutical company for off-label marketing and false advertising about several different psychiatric drugs. Somehow in September of 2014, I missed  a big one. 

That time, a large fine was assessed against my least favorite of all the drug companies, Shire Pharmaceuticals - the maker of the methamphetamine clones Adderall and Vyvanse. They also make a version of Ritalin called Daytrana.

As far as I'm concerned, this company is nothing but a dope dealer that cares only for profits and not a whit for their victims - er, I mean consumers. The company does its best to convince doctors to dope up kids who have various behavior problems - which in reality are mostly due to problematic parenting and/or chaotic home environments - with highly abuseable and dangerous stimulants. 

I have written several posts on the huge increase in prescriptions for these medications in children over the last twenty years or so. Now, we are seeing a huge increase in prescriptions of these drugs to adults for the adult version of "ADHD." While there may be both adults and children with minimal brain dysfunction who have a real disorder that requires this medication, most people who are given this diagnosis present with symptoms which are caused by other factors. The biggest ones: the effects of bad environments mentioned above which create anxiety and low moods, and amphetamine abuse. The later patients lie to their physicians in order to get the drugs. 

The drugs not only get people high, but are also used as performance-enhancing drugs for mental activities—much like steroids are used to enhance performance for physical activities.

Currently, medications to treat ADHD are one of the most lucrative sectors of the US drug market, totaling more than $10 billion in sales - 83 million prescriptions in 2014, according to data from IMS Health, ”with adults using more of these medications..." The “2013 edition of the Diagnostic and Statistical Manual of Mental Disorders... relaxed the definition for” ADHD in adults."

ADHD symptoms are easily faked. A 2010 study found that 22% of adults tested for ADHD exaggerated their symptoms. And that was probably only those subjects who would admit to it! Such exaggeration has been made much easier by the wide availability of online symptom checklists. 

Getting back to the matter at hand, Shire Pharmaceuticals LLC  paid a $56.5 million fine to resolve civil allegations that it violated the False Claims Act as a result of its marketing and promotion of these drugs. As one can easily see from the above figures, that's actually a very small cost of doing business. Among other things, they marketed Adderall XR based on unsupported claims that Adderall XR would prevent poor academic performance, loss of employment, criminal behavior, traffic accidents and sexually transmitted diseases. 

Shire medical science liaison allegedly told a state formulary board that Vyvanse “provides less abuse liability” than “every other long-acting release mechanism” on the market.  However, 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. Shire also made allegedly unsupported claims that treatment with Vyvanse would prevent car accidents, divorce, arrests and unemployment. 

Interestingly, the Justice Department was alerted to these marketing practicing by whistleblowers. The allegations arose from a lawsuit filed by Dr. Gerardo Torres, a former Shire executive, and a separate lawsuit filed by Anita Hsieh, Kara Harris and Ian Clark, former Shire sales representatives. The lawsuits were filed under the False Claims Act’s whistleblower provisions, which permit private parties to sue for false claims on behalf of the government and to share in any recovery. 

The marketing of stimulants for "adult ADHD" is as heinous as the marketing to children and teens. According to an article published by Medscape, "... the prevalence of [supposed] ADHD in adults these days is about half that in children. For years, the legitimacy of the adult ADHD was based on the belief that it was a condition that started in childhood and, for some, persisted into adulthood. 

But last year that hypothesis was shaken by the publication of a provocative, long-term study that followed more than 1,000 New Zealand children until age 38. In that study Terrie Moffitt, PhD, a psychologist at Duke University, and her colleagues found that in childhood, 6% of those in the study had ADHD. At age 38, that number had dropped to 3%.

And the biggest surprise was the lack of evidence of significant overlap between the two groups. Only 5% of those with ADHD in childhood still met the criteria at age 38. And only 10% of those who met the definition at age 38 were among those with the supposed condition in childhood.
The Medscape news article concluded from this data that "Studies suggest people diagnosed with ADHD as adults may have a condition that differs from ADHD seen in children." Wow. I would come to a different conclusion. Namely, that most of these patients did not have "ADHD" at all, but something else entirely.
And in yet more marketing-of-dope-to-children news (without a peep out of the pesky National Institute for Drug Abuse or the FDA), there’s a new, candy-flavored amphetamine on the market. Adzenys is chewable and fruity! Dr. Alexander Papp, affiliated with University of California, San Diego, asked, “What’s next? Gummy bears?”

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