Little red pills, given off-label to seniors by the millions, are no laughing matter

nudextaWith baby boomers leading a graying wave that’s sweeping the nation, there’s little wonder why there’s a furious search under way to medically assist and to support seniors suffering from dementia and Alzheimer’s Disease. But should the appropriate response be to burst out laughing, crying, or just to scream out loud about Avanir Pharmaceuticals’ little red Nudexta pills and how they’re getting foisted by the millions on the elderly in nursing homes?

CNN deserves credit for its reporting on the sketchy prescribing of Nudexta. Millions may know something about this drug due to the barrage of commercials for it, featuring the accomplished actor Danny Glover (hope he got a giant paycheck for this role).

Authorities have approved Nudexta to treat sudden and uncontrollable laughing or crying, aka the pseudobulbar affect or PBA. Less than 1 percent of all Americans suffer from PBA, which most commonly is seen in those with multiple sclerosis (MS) or ALS, also known as Lou Gehrig’s disease.

But CNN looked at prescribing and other records to discover that:

Since 2012, more than half of all Nuedexta pills have gone to long-term care facilities. The number of pills rose to roughly 14 million in 2016, a jump of nearly 400 percent in just four years… Total sales of Nuedexta reached almost $300 million that year. Nuedexta is being increasingly prescribed in nursing homes even though drug maker Avanir Pharmaceuticals acknowledges in prescribing information that the drug has not been extensively studied in elderly patients—prompting critics to liken its use to an uncontrolled experiment. The one study the company conducted solely on patients with Alzheimer’s … had 194 subjects and found that those on Nuedexta experienced falls at more than twice the rate as those on a placebo.

Geriatric medical experts said it is rare for dementia patients to suffer PBA, and they told CNN that it would be hard to explain or to justify not only prescribing the drug for seniors’ care but also to do the same for “off label” use. Physicians may prescribe an approved prescription medication in this way, if they can make the medical case that it is beneficial.

But the broadcaster’s reporting also found—surprise, surprise—that some of the practitioners who are writing the leading and large volumes of Nudexta scripts at nursing homes also have received payments from Avanir, as expert speakers, consultants, or for company-related perks, including meals and swag.

CNN has detailed not only how one nursing home psychiatrist racked up more than $600,000 in payments in three years from Avanir while aggressively prescribing Nudexta, the broadcaster’s investigation delves into the drug makers’ robust sales campaigns, including some directed at nurses.

If this story weren’t sufficiently infuriating already, there’s more: Taxpayers are funding the burgeoning and dubious prescriptions, and the federal Centers for Medicare and Medicaid Services, which has cracked down before on abusive dispensing of psychiatric medications in nursing homes, seems to be dawdling on Nudexta. This is odd, not only given the huge sums at stake but also because CMS also would have to accept Nudexta’s off-label use in elder care.

In my practice, I certainly see not only the significant harms that patients suffer while seeking medical services but also the neglect and abuse inflicted on seniors in nursing homes, including by giving them dangerous drugs. It is simply unacceptable for cost-cutting, staff-short facilities to seek to restrain nursing home residents in unethical fashion by giving them powerful psychiatric medications, and officials have made some advances (with drugs like Risperdal, Seroquel, and Zyprexa) that they cannot now reverse with the prescribing, without appropriate medical evidence, of another drug like Nudexta.

The quest for an Alzheimer’s therapy with positive outcomes has been, without doubt, long, expensive, and even dispiriting. But considerable experience has demonstrated that rigorous, extensive, and appropriate testing of drugs—which neither hastens bad ones to the market nor that keeps good ones away too long from those in need—best suits the health, safety, and pocketbooks of most Americans. This also is reason why politicians and policy-makers should proceed with caution when they talk about speeding up drug approval processes and when they bang them up with proliferating and officially approved off-label uses. The free-marketeers in Arizona and elsewhere will dread the day when their easily espoused philosophical views become bitter realities of patients harmed or dead when off-label treatment, effectively, transforms into gross human experimentation.

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