Drugmakers discover tardive dyskinesia. And they profit in it.

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Before direct-to-consumer ads, physicians tried to reassure patients they were probably fine. Today, drug ads and online symptom checkers do just the opposite. The most insidious are “unbranded” ads that scare people about a disease without mentioning the drug they are trying to sell. Notable unbranded disease campaigns sell the obscure exocrine pancreatic insufficiency, shift work sleep disorder, and non-24-hour, sleep-wake disorder. Unbranded advertising is designed to appear like a public health message from the CDC, and some even run free on TV and radio as “public service announcements.”

The latest unbranded disease campaign is for tardive dyskinesia (TD), a constellation of involuntary movements, often permanent, associated with neuroleptic/antipsychotic drugs. Unlike non-24-hour sleep-wake disorder and the like, TD is a widespread, consequential condition adding to the stigma endured by people with severe psychiatric conditions. It has become more common, even among the young, as second general antipsychotics (SGA) are marketed for nonpsychotic conditions like autism, bipolar disorder, conduct disorders, ADHD, anxiety, and depression. SGAs were largely approved on their putative lower risk of causing TD compared to first-generation antipsychotics (FGA), but clinicians are now seeing the same side effect. Are the drugs even atypical some are asking? Were approvals too hasty?

While tetrabenazine has been used in TD treatment, its suicidal side effects have limited its usefulness.

Two years ago, the FDA approved valbenazine (Ingrezza) sold by Neurocrine Biosciences and deutetrabenazine sold by Teva (Austedo) for the treatment of DT, and now unbranded TV ads and websites for TD abound as if the condition has just been discovered.

Like other unbranded marketing, TD ads and websites omit mention of any drug names but urge people to see their doctors and describe all their symptoms. Web sites even offer a “discussion guide” to make sure the physician prescribes the exact drug being marketed — co-opting the patient in the sales effort as most DTC marketing does. Ads also urge people not to stop the drug causing their TD.

Why object to a treatment for TD if it works? First of all, there is price.

Ingrezza would cost $752,080 and Austedo, $1,100,773 based on quality-adjusted year life (QALY) measures says Managed Care magazine. Industry price gouging has become so blatant that both sides of the congressional aisle are alarmed.

Novartis’s cancer drug, Kymriah, costs $475,000 per patient. Actimmune, a drug to boost the immune system in chronic granulomatous disease, costs $52,321.80 for one month, and the gallstone drug Chenodal costs $42,570 a month. We all know the price of Hep C drugs.

While industry claims the six and even seven-digit prices of new drugs it is rolling out reflect “research,” the prices are widely seen as opportunistic or even extortionary — an offer patients, clinicians, and insurers “can’t refuse.”

Secondly, add-on drugs are a shrewd strategy to double and triple-drug industry profits. Don’t stop your drug just because it doesn’t seem to be working or is causing uncomfortable side effects — add another drug or two has been the “polydrug” message for years. Don’t forget Seroquel, an aggressively prescribed SGA, is itself an add-on drug when antidepressants aren’t working.

Meanwhile, drugs that are sorely needed, such as antibiotics for carbapenem and vancomycin-resistant bacteria are conspicuously not developed because they are not profitable to industry — even when our tax dollars are handed to industry to develop them. How about an antifungal drug to treat candida auris, increasingly becoming a hospital scourge? No, the drug industry would rather seek Wall Street riches at the price of public health.

There are two more suggestions when it comes to the stigmatizing TD. Why can’t industry develop antipsychotic drugs that don’t cause it — or would that not be as profitable as an add-on expensive drug? And how about requiring informed consent forms from all the patients cavalierly put on SGAs for conditions like autism, bipolar disorder, ADHD, anxiety, and depression in which they acknowledge that they might be condemned to lifelong TD? That would likely reduce the number of TD sufferers.

Martha Rosenberg is a health reporter and the author of Born With a Junk Food Deficiency.  

Image credit: Shutterstock.com 

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