Behavioral and Developmental Pediatrician, Author, UCSF Clinical Faculty
July 31, 2014
July 31, 2014
During my entire 30-plus-year career as a behavioral/developmental pediatrician in private practice, I have attended only one drug company-sponsored dinner where I was paid for just showing up.
In 2003, I received a letter from Eli Lilly and Company, inviting me to hear a former Columbia Medical School classmate -- what an amazing coincidence -- talk about Strattera (atomoxetine), Lilly's new drug for the treatment of ADHD/ADD (attention deficit/hyperactivity disorder and non-hyperactive inattention). The dinner would be at the Ritz-Carlton in San Francisco, one of the city's fanciest venues.
As an additional inducement, I was offered a $500 "consulting fee" and a continuing medical education (CME) credit in return for listening to this one-hour presentation.
I had been to enough industry-sponsored CME lectures to know that the session would have a biological/medication slant that I don't share. Plus, the presentations were often insultingly simplistic and capped off by an obvious sales pitch.
Still, I was intrigued; what would I have to do for my $500? After a bit of a struggle, I arranged to have the money donated to the Omega Boys Club of San Francisco. Then I went to the dinner.
In the lobby, I saw a colleague, a friendly chap with a strong biological/medication orientation, and we decided to sit together. After a leisurely, wine-accompanied repast, the lecture began, presented by my former classmate, Phil Buber (my pseudonym for him).
I remembered Phil as a nice, unassuming, somewhat lumbering guy, but not one of my med school's brighter stars. He did a decent job covering the symptoms of childhood ADHD: six of nine behaviors required for diagnosis on the impulsive, hyperactive side and/or six of nine behaviors on the inattentive side as enumerated in American psychiatry's bible, the Diagnostic and Statistical Manual (DSM)-IV.
Phil proceeded to give a perfunctory description of non-drug behavioral approaches to treatment. Then, right on schedule and according to script, he disparaged the medications currently in use for ADHD. Coming from a drug company shill, this should have been a surprise, but to the cognoscenti in the audience, it was not.
We all knew that Lilly had been touting Strattera as the first effective, non-stimulant medication for the treatment of ADHD/ADD. The best known of the stimulants -- Ritalin, Adderall, and the newer Concerta -- had grown into a $2 billion a year industry. They were all variations of amphetamine, a potentially abusable and addictive drug. Strattera was the first non-amphetamine brought to market for ADHD.
Even though there was contradictory evidence on the long-term risks of Ritalin-type drugs, Phil exploited the specter of later amphetamine addiction. (Later that year, Lilly's national campaign, which was directed at parents, would attempt to cash in on that same worry. Subsequent research concluded that childhood intake of amphetamines neither led to nor prevented future drug abuse or addiction.)
He droned on about the benefits of Strattera and exaggerated the risks of Adderall and Concerta, but I had already made up my mind about the drug, whose structure and pharmacology reminded me of the tricyclics (more about them later). If I were going to prescribe medication, I would stick to the stimulants. However, I knew my dinner partner was a pioneer and a risk taker, inclined to try new drugs with his patients.
We were still sitting together when Phil went around the room, polling the doctors in attendance on our attitudes about Strattera. He asked me, "So, Larry, what do you think about using atomoxetine with your patients?"
"Well, Phil, I'm a bit conservative when it comes to new drugs," I said. "So, I'll tell you what. When my friend here tells me in five years that Strattera works and has fewer side effects than Concerta, I might be ready to prescribe it."
The group laughed uneasily.
Strattera's backstory, which reflected marketing choices rather than an effective alternative, was the most intriguing -- and instructive -- thing about it. Atomoxetine, its generic version, had languished on the Eli Lilly shelves for more than a decade. In the 1980s, testing had shown it to be an adequate treatment for depression, but Lilly had just introduced its blockbuster product, Prozac, which seemed to be a bit more effective and also better tolerated. Consequently, Lilly didn't need another antidepressant to compete with its very, very successful product.
But then, a fortuitous set of circumstances coalesced in the late 1990s: ADHD diagnosis rates and treatments soared, and parents, desperate to treat their "chemically imbalanced" offspring, worried about the potential long-term side effects of amphetamines on their children.
Lilly also had another ace in its deck. It had recruited Harvard University's preeminent academic child psychiatrist, Dr. Joseph Biederman, and his team to take on atomoxetine research. Dr. Biederman, winner of many academic awards, was arguably at the time the single most powerful and influential psychiatrist in America.
He later became embroiled in conflict-of-interest scandals that were covered by major American media outlets, and his reputation has since suffered. But at that particular moment, he was at the height of his powers. All Biederman had to do was whisper the name of a new drug at a medical conference, and tens of thousands of prescriptions for that drug would be written by M.D.s across the nation.
At one point, Biederman's team had promoted tricyclics -- older, non-stimulant antidepressant drugs -- as alternatives for ADHD when stimulant drugs failed to improve behavior, side effects were too great, or there was a risk of abuse. However, in the 1980s, after several reports of children suddenly dying while taking desipramine (one of the tricylics), use of these types of compounds for ADHD essentially ended.
I had not been surprised when an article by Biederman and his team appeared in the July, 2002 Journal of the American Academy of Child & Adolescent Psychiatry on the use of atomoxetine as a treatment for ADHD. I was surprised, however, to learn that on the very same day the article was released to the press, Biederman hosted a Wall Street news conference under the auspices of Eli Lilly.
The timing and blatant nature of the pecuniary partnership between America's leading academic child psychiatrist and a Fortune 500 mega-corporation had left me feeling sad, angry, and alone. Where were other doctors, patients, the public, and the press?