Overcoming Drug Addiction

Since the early days of the neurotechnology industry, a major challenge confronting vendors and researchers has been overcoming obstacles presented by the pharmaceutical industry. Though much progress has been made, there is still a bias among many clinicians, regulators, payers, and patient advocacy groups who see drugs as the only viable therapy, and regard neurotech devices as a last resort, if at all.

As NBR senior consulting editor Jeremy Koff points out in his report from the American Headache Society meeting, although neuromodulation vendors were on the scene, the agenda was dominated by big pharma firms. And a similar situation exists, in our view, with respect to Alzheimer’s disease.

The FDA has granted breakthrough device designation to three neurotech vendors pursuing novel therapies for Alzheimer’s, including Functional Neuromodulation, with its DBS fornix approach, Cognito Therapeutics, pursuing photomodulation to improve synaptic connections, and NeuroEM Therapeutics, with its transcranial electromagnetic therapy. But the media and the healthcare establishment still seems transfixed on pharmaceutical therapies. This despite the continued string of failures coming from that sector. The FDA last year approved Biogen’s Aduhelm drug, despite anemic supporting data. The U.S. Health and Human Services inspector general later reviewed allegations that the FDA had an “inappropriately close relationship” with the pharmaceutical industry. And this year, CMS denied coverage for the drug except in clinical trials, prompting the company to scale back its commercialization efforts.

In a recent issue of Science magazine, commentator Derek Lowe lambasted big pharma’s folly pursuing the amyloid hypothesis to treat Alzheimer’s, pointing out repeated trial failures by Biogen, Eli Lilly, Roche, and others. “I do not believe that targeting amyloid is going to lead to a useful Alzheimer’s therapy, and watching these trials feels to me like watching someone trying to put out an oil well fire by dumping duffel bags of money onto it from helicopters,” he quipped.

At the recent BIO International Convention in San Diego, this editor moderated a session on Alzheimer’s. The session featured Dheeraj Talreja from Genentech, Russ Paulsen, COO of the nonprofit UsAgainstAlzheimer’s, and Soeren Mattke, a professor at the University of Southern California. The panelists aptly elucidated the massive toll that the disease is taking on society and the need for overcoming barriers to treatment. But their discussion of therapies in the pipeline centered exclusively on drugs, despite the fact that NeuroEM had presented at the meeting.

Hopefully, the pharmaceutical industry will soon come to recognize the potential value that neurotech therapies can offer patients and their bottom line.

James Cavuoto


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