Drugs

Restrict 2 Opioid Indications: Petition

Physician Douglas R. Smith is asking FDA to severely curtail the use of the indications of opioid addiction and opioid use disorder. His just-released 2/18 petition says the agency should curtail the indications for treatment and for manufacturing. It is the second opioid-related petition Smith has submitted. His 12/17/2024 petition asked FDA to “take all steps possible to stop the further opioid-induced genetic poisoning of our citizens, and to take all steps possible to rescue those citizens already genetically poisoned by the opioids and experiencing the horrendous symptoms of said poisoning.”

The latest petition argues that “opioid addiction/opioid use disorder are not indications derived of a scientific process and are not suitable as an indication for the manufacturing and marketing of a pharmaceutical product. Because opioid addiction/opioid use disorder is not a proper diagnosis, and as they were used as if they were a legitimate diagnosis, millions of people were denied a proper diagnosis and a proper treatment.”

The petition specifically asks that FDA immediately implement:

a Boxed Warning stating that opioids are known to cause genetic damage consisting of methylation in the OPRM1 gene;
a Dear Provider letter notifying the medical community of the Boxed Warning associated with all opioids;
a Risk Evaluation and Mitigation Strategy for the opioid-induced genetic damage to the OPRM1 gene;
enabling the treatment IND associated with the Phase 3 clinical trial;
a Boxed Warning for all opioid antagonists stating that they have been associated with catecholamine toxicity when administered to the opioid-dependent population;
a Dear Provider letter notifying the medical community about the Boxed Warning associated with opioid antagonist usage in the opioid-dependent population;
recommended genetic testing to include detection of methylation in the OPRM1 gene for all opioid-dependent individuals;
recommended genetic testing to include detection of methylation in the OPRM1 gene for all children born of an opioid-dependent parent who may have inherited the abnormal methylation in the OPRM1 gene;
funding for the first 10,000 participants in the treatment IND;
funding of seed money to begin scientific research for a genetic therapy for the abnormal methylation due to recurrent opioid exposure; and
restrictions on the use of the terms opioid addiction/opioid use disorder to that percentage of the target patient population that tests negative for the genetic damage from opioids.

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