NewsNationNow recently ran an article with the following lead: “Study: Epilepsy drug could reverse autism symptoms”
Now, when you see the graphic and read the words, what do you think. You see “epilepsy drug,” “reverse autism symptoms,” and a picture of a human head and brain. These may lead you to believe that scientists are working on a study of autistic humans who are given an epilepsy drug resulting in some change to their internal state such that what society considers “autistic symptoms” are either minimized or eliminated. You might think that … and you would be wrong.
Below the graphic, you’ll find the following quote, “Researchers discovered a common epilepsy drug may reverse symptoms of autism, at least in mice.”
Mice? This again?
They go on. “In the recent study, researchers used the drug lamotrigine, typically used to treat epilepsy, to treat mice with a MYT1L abnormality. The mice treated with lamotrigine showed a reversal in some behaviors associated with autism, including hyperactivity.”
The study then goes on to include lots of “could” statements. The authors didn’t include a reference or refutation of a 2001 study, “Lamotrigine Therapy for Autistic Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial.” In that study, the authors conclude, “Our results lead us to conclude that lamotrigine does not improve certain autistic behaviors as compared to placebo.” Same drug, different results.
What’s the difference between the two studies?
The older study used humans, was double-blind, and was placebo-controlled. In the new study, they used mice and models. Why do you think the new study was commissioned? A new off-label use of an old drug, perhaps?
What is off-label use?
Whilst off-label use may be a new concept to many, in medical practice in the U.S. it is relatively routine (Study Conclusion: Off-label medication use is common in outpatient care, and most occurs without scientific support. Efforts should be made to scrutinize underevaluated off-label prescribing that compromises patient safety or represents wasteful medication use). Other studies suggest that approximately 20% of all prescriptions are administered off-label.
In pediatrics, off-label use is even more common because fewer clinical trials of the kind required for the FDA approval process are conducted in children. The American Academy of Pediatrics endorses off-label use as an available tool “to benefit the individual patient” based on a pediatrician’s clinical judgment and the best evidence available. Another study suggested that over half of pediatric hospitalizations involve treatment with at least one off-label medication.
Reasons for off-label use vary. Practically, the time and cost to conduct additional clinical trials on an already-approved medication is burdensome. Some products proven to be safe for use for a specific reason are later found to be effective for a new purpose. Off-label use helps make these treatments more accessible to other populations who may benefit from them.
Within the medical profession, off-label use is seen as an ethically and legally sound practice. The FDA does not permit physicians to conduct experimental research on patients outside of clinical trials. But the law does permit physicians to prescribe FDA-approved products off-label for the purpose of “enhancing a patient’s well-being.” Doctors face no heightened risk of malpractice liability when they follow informed consent processes, when clinical data suggest that the anticipated benefits likely outweigh known risks, and when the medication was prescribed for “the patient’s benefit” rather than for research.
With these considerations in mind, you will likely see lamotrigine (the epilepsy drug) considered for off-label use in autism “to benefit the patient” and “enhance their well-being” by “reducing their symptoms.” It benefits drug companies, like GlaxoSmithKlein, to find off-label uses of their medicines. This helps their profits by finding new customers for their existing medicines. Drugs.com lists Lamictal (the trade name of lamotrigine) starting at $17.03 per tablet, or $596.17 per bottle of 35 for it’s lowest dose option. That’s a whole lot of money for a product that’s gone generic. The generic prices are much cheaper. But, the point remains. Finding a new use for a drug makes them money … and costs the patient money that could be used elsewhere. If you can afford to take a medication with some pretty harsh known side effects, one without a proven track record for the thing you’re complaining about, then go right ahead. As for me, I’ll hold off on taking a triazine anti-convulsant drug in the hopes that what makes me me (autism) will somehow be lessened. No thanks.