Psychiatrists convened in sunny Honolulu for the 164th Annual Meeting of the American Psychiatric Association (APA) last week, discussing, among other things, moving forward with plans to make the diagnostic criteria for ADHD less stringent: proposed changes include reducing the number of required symptoms from 6 to 4, for adults and teens, and increasing the age-of-onset criteria from 7 to 12.

Russell Barkley, Ph.D., and Joseph Biederman, M.D., have written about abandoning or generously broadening age-of-onset criteria, arguing that the current, precise age-of-onset criteria poses “unwarranted practical problems for the study of older adolescents and adults.” these two men are considered ADHD experts and contributed to the American Academy of Child and Adolescent Psychiatry (AACAP) Practice Parameters for ADHD, which serve as guidelines by which most child psychiatrists practice.

According to a story from the New York Times, Joseph Biederman did not tell university officials about more than a million dollars received from drugmakers from 2000 to 2007, and he promised Johnson & Johnson research results that would benefit the drug company. On the list of AACAP Conflicts of Interests for Practice Parameters not listed in the Practice Parameters, Russell Barkley receives or has received research support, acted as a consultant and/or served on a speaker’s bureau for Eli Lilly and Company and Shire Pharmaceuticals Group.

Shire Pharmaceuticals Group has a substantial focus on ADHD meds, and they have been pulling out all the stops to try and turn a profit in the face of competition from generic drugs.

Earlier this month, Reuter’s Health described how drugmakers, including Shire, have raised prices to make up for lack of new products and loss of patent protection.

“Prices were just shoved up every year to make more money and meet earnings, to be blunt,” Shire (SHP.L) Chief Executive Angus Russell said.

Shire’s CEO also indicated that the FDA is supporting their plan to study the use of their ADHD drug, Vyvanse, for use in depression and schizophrenia, hoping for billions of dollars in extra sales through expansion of potential indications. Amphetamines for schizophrenia? Hmmmm…..

Jim Edwards of BNET wrote about Shire increasing the price of one of their own ADHD drugs, Adderall XR, to encourage users to switch to their branded, cheaper and newer ADHD drug, Vyvanse, leading to increased sales.

Shire somehow sold more ADHD drugs during a recent, national shortage of ADHD medications – their sales of Adderall XR increased 21 percent in the first quarter of 2011 – a time when many of the patients in San Francisco’s public mental health system were unable to receive their regular ADHD medications.

BNET posted excerpts of separate lawsuits filed by Impax and Teva, manufacturers of generic forms of Adderall XR. They claim that Shire did not honor their contracts and hoarded product for themselves during this recent shortage. In the Wall Street Journal, the associate director of FDA’s drug shortages program reported that this national ADHD drug shortage mostly affected generic forms of ADHD meds. Coincidence?

Other ways of getting around stagnant drug development and generic competition include taking an old drug or active ingredient, and changing the delivery system or duration of action and presenting it as a new, patent-protected product. Here are a few examples that have been associated with Shire:

- Vyvanse: Also known as lisdexamfetamine, Vyvanse is a prodrug of dextroamphetamine. Dextroamphetamine has been used since 1937 to treat hyperactivity in children, so it is hardly new. Vyvanse was marketed as having lower abuse potential – specifically, preventing abuse from snorting, since the prodrug requires digestion to release the active form. In my clinical experience, most abuse of stimulants is due to people taking it without a prescription or shaping their symptoms to get a prescription, and a prodrug likely does little to curb college students from seeking stimulants to study for exams.

- Daytrana: The transdermal methylphenidate (methylphenidate is the active ingredient in Ritalin) patch is worn on the skin and was developed as a way of bypassing the digestive tract, and my experience prescribing this drug was met with equivocal reports from patients and families. I guess there is a reason I can’t remember anyone saying it worked – Shire gave up on the ADHD patch after 9 product recalls and a federal probe.

- Intuniv: An extended release form of guanfacine, Intuniv is touted as a new, non-stimulant treatment for ADHD. but child psychiatrists have been using guanfacine in ADHD for years, and this ‘extended-release’ form has a half-life of about 18 hours, while generic guanfacine has a half-life of about 17 hours – not a robust difference, in my opinion.

I liken these approaches to gimmicks utilized in the mass-produced, beer market: color changing labels to let you know if your beer is cold, wide-mouth beer cans, or vortex bottles. Do any of these ‘innovations’ really change the fact that you’re drinking cheap beer?

As the DSM-V looms closer to becoming a reality, I can’t help but think of words from the man who chaired the committee for the DSM-IV. Allen Frances, M.D., wrote in the in the LA Times:

As chairman of the task force that created the current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), which came out in 1994, I learned from painful experience how small changes in the definition of mental disorders can create huge, unintended consequences.

Our panel tried hard to be conservative and careful but inadvertently contributed to three false ‘epidemics’ – attention deficit disorder, autism and childhood bipolar disorder. clearly, our net was cast too wide and captured many ‘patients’ who might have been far better off never entering the mental health system.

The DSM-IV was and the DSM-V will be published by the APA. The same APA that, in 2010, rejected internal recommendations – led by an APA past-president – to regulate or curtail individual psychiatrists’ relationships with the pharmaceutical industry.

Loosening the diagnostic criteria for ADHD, as proposed, will no doubt lead to more people being diagnosed and, inevitably, taking more ADHD drugs. I like to think that the APA and their doctors pushing for the changes are motivated by helping patients and not drug company profits.

After all, if anyone can identify and address unconscious conflicts or psychologically-defended, aggressive drives, it’s a psychiatrist, right?

Posted By: Winston Chung MD (Email) | May 25 2011 at 06:45 AM