Alzheimer’s drug unproven, expensive

IN FEBRUARY 2019 the FDA took action against companies for selling dietary supplement products claimed to treat Alzheimer’s disease. The agency posted 12 warning letters and five online advisory letters to those corporations.

Then-FDA Commissioner Dr. Scott Gottlieb said, “Science and evidence are the cornerstone of the FDA’s review process and are imperative to demonstrating medical benefit, especially when a product is marketed to treat serious and complex diseases like Alzheimer’s ... and we will continue to take action to protect patients and caregivers from misleading, unproven products.”

The FDA recently approved Biogen Inc.’s controversial and outrageously expensive Alzheimer’s drug earlier this month without firm evidence the drug helps patients, and Eli Lilly & Co plans to file for accelerated approval for its experimental Alzheimer’s treatment using the same justification the FDA used for Biogen’s.

Apparently if offered by a big drug company, “safe and effective” does not apply nor does the FDA consider whether anyone, including Medicare, can afford the drug. I wrote the FDA regarding high drug prices and was advised to contact the Federal Trade Commission as prices are not in their purview. Some basic considerations should be!

Preventing citizens from buying drugs and supplements competitively on the international market while allowing drugs of questionable efficacy and bankrupcy-precipitating prices suggests the big drug companies are feeding the FDA watchdog.

The current directors’ performance sparked protest from opioid crisis organizations in January of this year.

The FDA needs leadership that is not a rubber stamp for the industry it regulates.

DENNIS ROSSBACH Corrales