A review of the evidence for each newly approved peptide and the named FDA advisory committee members who have a financial interest in the votes they just cast.
Good question. BPC-157 went into human trials in Europe years ago under a code name, PL 14736, run by the Croatian drug maker Pliva. The company took it through an early safety study in healthy volunteers and then a mid-stage trial in patients with ulcerative colitis, a serious bowel disease. The trial reportedly showed some benefit with no obvious harm. But Pliva never published the full results, so no outside researcher could check the work. Then the program was shelved.
Pliva was later absorbed by Teva Pharmaceutical (the world's largest maker of generic drugs. It had bought Barr Pharmaceuticals in 2008, and Barr then bought Pliva in 2006. So through those deals, BPC-157 ended up inside a giant generics company that had little interest in pushing an unproven peptide through the rest of clinical testing, and it got shelved). BPC-157 never won approval anywhere, and it resurfaced as the gray-market injectable people buy today.
Another safety trial registered in 2015 but cancelled the next year, again with nothing published.
Let me get this straight….for years Kennedy has railed against the FDA for being in the pockets of big pharma. So when he gets the levers of power he sets up a committee of peptide investors to vote on peptides and ignore the scientific community ?! It’s ludicrous! You know what never happened? Big pharma voting on the approval of their own products.
Has BPC-157 been tested in Europe?
Good question. BPC-157 went into human trials in Europe years ago under a code name, PL 14736, run by the Croatian drug maker Pliva. The company took it through an early safety study in healthy volunteers and then a mid-stage trial in patients with ulcerative colitis, a serious bowel disease. The trial reportedly showed some benefit with no obvious harm. But Pliva never published the full results, so no outside researcher could check the work. Then the program was shelved.
Pliva was later absorbed by Teva Pharmaceutical (the world's largest maker of generic drugs. It had bought Barr Pharmaceuticals in 2008, and Barr then bought Pliva in 2006. So through those deals, BPC-157 ended up inside a giant generics company that had little interest in pushing an unproven peptide through the rest of clinical testing, and it got shelved). BPC-157 never won approval anywhere, and it resurfaced as the gray-market injectable people buy today.
Another safety trial registered in 2015 but cancelled the next year, again with nothing published.
Let me get this straight….for years Kennedy has railed against the FDA for being in the pockets of big pharma. So when he gets the levers of power he sets up a committee of peptide investors to vote on peptides and ignore the scientific community ?! It’s ludicrous! You know what never happened? Big pharma voting on the approval of their own products.
Thanks, Paul. Great summary and facts. I’ll keep it in my back pocket for the next person who tells me injected peptides are amazing.