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How Adderall slipped through the cracks

BY SAM SINGER: SAM'S CLUB

Published March 15, 2005

Dextroamphetamines. The Reagan-era blockbusters that revolutionized modern behavioral therapy and bridled a generation of restless children. Pharmaceutical companies grossed billions while Adderall (along with its psychotropic sisters Dexedrine and Ritalin) was embraced as the world’s first child-friendly amphetamine — the one federally controlled substance that could rightfully accompany Flinstone vitamins at the breakfast table. With age came new prescriptions, with those, higher doses. Attention Deficit Disorder had become an epidemic of the upper class, a disease only for those who could afford a diagnostic test. The drug’s popularity soared alongside its users’ grade point averages, and the market for medicating hyperactivity exploded. By the time Adderall encountered its first dorm room, its biochemical signature had already been left on our generation.

The drug’s subsequent collision with contemporary college life is too weighty a topic for such limited space. The list of talking points is exhaustive: How bad is the abuse problem? (A Johns Hopkins study estimates the medication can be found in the blood streams of one-fifth of college students nationwide — a figure that doesn’t begin to account for recreational use). Has it been over-prescribed? (Pharmacies in the United States fill close to a million prescriptions per month). What about academic integrity? While some call it a miracle drug, others believe it’s some sort of scholarly steroid. Each of these matters has heard its share of lip-service — I’ll keep my distance. I’m just looking for the answer to one question: can Adderall kill you?

Last month, citing rising incidence of unexplained sudden deaths, Health Canada (Canada’s equivalent of the U.S. Food and Drug Administration) pulled Adderall XR from domestic pharmaceutical markets. Canadian authorities had linked twenty mortalities between 1999 and 2003 to the consumption of the central nervous stimulant, 14 of which occurred in children. After a preliminary review, the FDA has publicly contested Health Canada’s findings. Adderall-induced heart failure, our federal scientists have maintained, is not common enough to warrant suspension of the drug. Granted at face-value, 20 deaths in four years is considerable, but many of the medical debate’s finer points remain murky. Exactly how many of the subjects in question had prior structural or cardiac abnormalities is unclear. There were, unquestionably, a number of previously-healthy users (namely children) whose deaths were directly related to short-term exposure. Health Canada also blames the drug for 12 strokes over the same four year period, two of which proved fatal. Officials have pinpointed irregular heart rate fluctuations — one of Adderall’s more notorious side effects — as the source of the blood clots.

The disputes are dicey, and my yet-to-be-completed political science degree gives me little authority to referee. It’s in times like this that I like to defer to the time-honored, tax payer-funded acumen of the U.S. Federal Government. Any other week I’d be hard-pressed to take Canada’s word over the FDA’s — the world’s acknowledged gold standard on drug safety matters. Truth be told, had it been written half a year ago, this column would have likely been a 400-word pot-shot at our regulation-happy neighbor to the north.

Not today. Six consecutive months of oversight lapses have left the FDA neck-deep in controversy. It began last September when the agency released warnings of heightened suicide risks for children prescribed to top-shelf antidepressants like Paxil and Zoloft — results, the media would learn, the FDA had kept buried for almost a year. After an early-winter panic over a batch of contaminated flu vaccines, February brought news that FDA-approved Vioxx, Merck Inc.’s blue-ribbon painkiller, may have contributed to the premature deaths of more than 30,000 Americans with prior heart complications. Congressional oversight has since intensified, and lawmakers have zeroed in on the agency’s clinical review of Adderall and other dextroamphetamines.

What would another drug safety scare mean for the FDA? With hundreds of politically-charged legislators breathing down its neck and a rapidly deteriorating public relations crisis, the embattled agency is in no place to pull Adderall from consumer markets — especially if it would mean bowing out to the Canadian government. If you want more than circumstantial evidence, get this: Iowa Sen. Charles Grassley (R) claims agency whistleblowers have told him that in a shameless effort to save face, senior FDA officials asked Health Canada not to suspend sales of Adderall. Coming from one of the more esteemed members of the U.S. Senate, that’s some pretty powerful hearsay.

Adderall may well be the next life-threatening drug to have slipped through the bureaucratic cracks. Still a pharmaceutical tadpole, Adderall’s youth precludes any reliable assessment of its long-term health impacts. Once graduated from its test phase, Adderall was simply left to proliferate - its lasting health hazards left to the FDA’s post-approval review process. Regrettably, understaffed and scantly funded, the agencies on-the-market surveillance strategies are frighteningly passive. Instead of continuing to test drugs while in circulation, regulators are more likely rely on manufacturer-supplied clinical reviews and monthly progress reports.

Whether you can stomach it or not, it’s our University’s students — the overworked freshman and the strung out J.D. candidates, the exhausted history majors and the nocturnal M.B.A.’s — that make up the control group for the most critical phase of the FDA’s Adderall test trials. The drug was first floated on the market as a mild stimulant, let’s hope it doesn’t leave a killer.

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Singer can be reached at singers@umich.edu.