Fast fail is a great strategy for cutting the cost of pharmaceutical trials (Our View, March 20). No one would argue against quickly eliminating new drugs that don’t work. Now we also need a strategy to observe how drugs affect patients and the health system over time before new medications are fast-tracked to approval.
Last year, a new drug for Alzheimer’s, Aduhelm, gained Food and Drug Administration approval. System impact included a projected increase of about $10 per month in Medicare Part B premiums just to pay for this one expensive new drug, which many FDA panelists said was unlikely to work.
Other medications create side effects that permanently damage general health. Zyprexa, prescribed for schizophrenia and bipolar disorder, creates extraordinarily rapid weight gain during use and a system reset to metabolic syndrome (“pre-diabetes”) that does not recede after drug cessation. Metabolic syndrome was recognized in pre-approval research, but was not considered sufficiently concerning to prevent approval. As a result, patients have suffered long-term harm to their general health.
Other anti-psychotic medicines are widely prescribed off-label for depression, post-traumatic stress, autism, and more. System impacts have included meds-induced tardive dyskinesia in an estimated half a million Americans. Until this century, these irreversible, involuntary muscle movements were seen only among long-term psych inpatients. Now they affect roughly 1 in 650 Americans.
Fast fail is good. But without long-term research that assesses the real risks of a treatment over time, the primary beneficiaries of this new research strategy will be pharmaceutical company shareholders.
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