Uploaded August 2026 | Updated September 2026, 3 weeks ago
Before you decide a missing trial does not matter, look at what happened the last three times. Fen-phen, Vioxx, and a compounding-pharmacy meningitis outbreak that killed 64 people all followed the same structure that is in front of the FDA now. This segment lays out each one and what it should teach you about approving drugs on thin evidence.
Timestamps:
00:00 What a missing trial costs
00:10 Fen-phen
02:28 Redux: a second panel says yes by one vote
03:28 Vioxx
05:20 The FDA got the science right and still could not act
05:38 The New England Compounding Center
07:08 The law that came out of it
07:50 "No safety data" is not "probably safe"
08:03 What the animal and adverse-event data show
Resources:
Barbell Medicine coaching and templates: barbellmedicine.com
Plus podcast subscription: barbellmedicine.com/shop/subscriptions/plus-podcast-subscription
Barbell Medicine Premium: barbellmedicine.com/shop/subscriptions/barbell-medicine-premium
Signal (book pre-order): barbellmedicine.com/shop/learning/signal
References:
1. FDA. PCAC briefing document. Jul 23-24, 2026.
2. FDA. BPC-157 bulk substance review. PCAC 2026. fda.gov/media/193343
3. FDA. TB-500 bulk substance review. PCAC 2026. Media 193349.
4. FDA. KPV, MOTS-c, Semax, Epitalon, Emideltide reviews. 2026.
5. FDA. Questions for the PCAC. Jul 2026.
6. FDA. PCAC roster 2026. Media 193772.
7. FDA. PCAC roster 2022. Media 159040.
8. openFDA. FAERS reports, BPC-157. open.fda.gov
9. 21 CFR 216.23 (2026).
10. FD&C Act 503A; 21 USC 353a.
11. Abigail Alliance v von Eschenbach, 495 F3d 695 (DC Cir 2007).
12. US v Rutherford, 442 US 544 (1979).
13. Right to Try Act of 2017, Pub L 115-176.
14. FDA. Peptide drug products. Draft guidance, 2020.
15. Ruenzi. PL 14736 (BPC 157) in ulcerative colitis. Gastroenterology 2005; abstract only.
16. Staresinic. BPC 157, transected rat quadriceps. J Orthop Res 2006;24:1109.
17. Gwyer. BPC 157 and soft tissue healing. Cell Tissue Res 2019;377:153.
18. Sikiric. BPC 157, hemorrhage/thrombosis. Pharmaceuticals 2026;19:463.
19. Stavchansky. Glyprolines and gene expression, Semax. Genes 2022;13:2380.
20. Mendias. Approved and unapproved peptides. Sports Med 2026.
21. Moseley. Arthroscopic surgery for knee OA. NEJM 2002;347:81.
22. Cobb. Internal mammary ligation, double-blind. NEJM 1959;260:1115.
23. Dimond. IMA ligation vs sham for angina. Am J Cardiol 1960;5:483.
24. Alfredson. Eccentric calf training, Achilles tendinosis. AJSM 1998;26:360.
25. Kongsgaard. Steroid vs exercise, patellar tendinopathy. Scand J Med Sci Sports 2009;19:790.
26. Langberg. Peritendinous metabolism during exercise. J Physiol 1999;515:919.
27. Coombes. Steroid vs physiotherapy, tennis elbow. JAMA 2013;309:461.
28. Kearney. PRP vs sham, Achilles tendinopathy. JAMA 2021;326:137.
29. Pavlova. Exercise dose in tendinopathy, meta-analysis. BJSM 2023;57:1327.
30. Weintraub. Fen-phen vs placebo. Clin Pharmacol Ther 1992;51:586.
31. Connolly. Valvular heart disease with fen-phen. NEJM 1997;337:581.
32. CDC. Valvulopathy with fenfluramine. MMWR 1997;46:1061.
33. Bombardier. VIGOR: rofecoxib vs naproxen. NEJM 2000;343:1520.
34. Graham. MI and sudden death, COX-2 inhibitors. Lancet 2005;365:475.
35. Smith. Fungal infections, contaminated methylprednisolone. NEJM 2013;369:1598.
36. Adunsky. MK-0677 after hip fracture. Arch Gerontol Geriatr 2011;53:183. Halted early, CHF signal.
37. Nass. Oral ghrelin mimetic in older adults. Ann Intern Med 2008;149:601.
38. Van Wagoner. Composition of SARMs sold online. JAMA 2017;318:2004.
39. ECRI/ISMP. Unapproved peptide products. Apr 2026.
40. CSPI. Are injectable peptides safe? cspinet.org
41. WADA. 2026 Prohibited List. wada-ama.org
42. USADA. BPC-157: a prohibited peptide. usada.org
43. Time. FDA panel backs compounding peptides. Jul 2026.
44. RAPS. Committee backs controversial peptides. 2026.
45. STAT. Panel okays peptides for compounding. Jul 2026.
46. NBC News. Panel eases peptide limits over FDA objections. 2026.
47. AP. Financial ties among FDA peptide panel members. 2026.
48. Leerink. PCAC vote and telehealth compounding market. 2026.
49. Examine.com. BPC-157 research breakdown. examine.com/supplements/bpc-157
50. Jarry. BPC: no proof required. McGill OSS. mcgill.ca/oss
Before you decide a missing trial does not matter, look at what happened the last three times. Fen-phen, Vioxx, and a compounding-pharmacy meningitis outbreak that killed 64 people all followed the same structure that is in front of the FDA now. This segment lays out each one and what it should teach you about approving drugs on thin evidence.
Timestamps:
00:00 What a missing trial costs
00:10 Fen-phen
02:28 Redux: a second panel says yes by one vote
03:28 Vioxx
05:20 The FDA got the science right and still could not act
05:38 The New England Compounding Center
07:08 The law that came out of it
07:50 "No safety data" is not "probably safe"
08:03 What the animal and adverse-event data show
Resources:
Barbell Medicine coaching and templates: barbellmedicine.com
Plus podcast subscription: barbellmedicine.com/shop/subscriptions/plus-podcast-subscription
Barbell Medicine Premium: barbellmedicine.com/shop/subscriptions/barbell-medicine-premium
Signal (book pre-order): barbellmedicine.com/shop/learning/signal
References:
1. FDA. PCAC briefing document. Jul 23-24, 2026.
2. FDA. BPC-157 bulk substance review. PCAC 2026. fda.gov/media/193343
3. FDA. TB-500 bulk substance review. PCAC 2026. Media 193349.
4. FDA. KPV, MOTS-c, Semax, Epitalon, Emideltide reviews. 2026.
5. FDA. Questions for the PCAC. Jul 2026.
6. FDA. PCAC roster 2026. Media 193772.
7. FDA. PCAC roster 2022. Media 159040.
8. openFDA. FAERS reports, BPC-157. open.fda.gov
9. 21 CFR 216.23 (2026).
10. FD&C Act 503A; 21 USC 353a.
11. Abigail Alliance v von Eschenbach, 495 F3d 695 (DC Cir 2007).
12. US v Rutherford, 442 US 544 (1979).
13. Right to Try Act of 2017, Pub L 115-176.
14. FDA. Peptide drug products. Draft guidance, 2020.
15. Ruenzi. PL 14736 (BPC 157) in ulcerative colitis. Gastroenterology 2005; abstract only.
16. Staresinic. BPC 157, transected rat quadriceps. J Orthop Res 2006;24:1109.
17. Gwyer. BPC 157 and soft tissue healing. Cell Tissue Res 2019;377:153.
18. Sikiric. BPC 157, hemorrhage/thrombosis. Pharmaceuticals 2026;19:463.
19. Stavchansky. Glyprolines and gene expression, Semax. Genes 2022;13:2380.
20. Mendias. Approved and unapproved peptides. Sports Med 2026.
21. Moseley. Arthroscopic surgery for knee OA. NEJM 2002;347:81.
22. Cobb. Internal mammary ligation, double-blind. NEJM 1959;260:1115.
23. Dimond. IMA ligation vs sham for angina. Am J Cardiol 1960;5:483.
24. Alfredson. Eccentric calf training, Achilles tendinosis. AJSM 1998;26:360.
25. Kongsgaard. Steroid vs exercise, patellar tendinopathy. Scand J Med Sci Sports 2009;19:790.
26. Langberg. Peritendinous metabolism during exercise. J Physiol 1999;515:919.
27. Coombes. Steroid vs physiotherapy, tennis elbow. JAMA 2013;309:461.
28. Kearney. PRP vs sham, Achilles tendinopathy. JAMA 2021;326:137.
29. Pavlova. Exercise dose in tendinopathy, meta-analysis. BJSM 2023;57:1327.
30. Weintraub. Fen-phen vs placebo. Clin Pharmacol Ther 1992;51:586.
31. Connolly. Valvular heart disease with fen-phen. NEJM 1997;337:581.
32. CDC. Valvulopathy with fenfluramine. MMWR 1997;46:1061.
33. Bombardier. VIGOR: rofecoxib vs naproxen. NEJM 2000;343:1520.
34. Graham. MI and sudden death, COX-2 inhibitors. Lancet 2005;365:475.
35. Smith. Fungal infections, contaminated methylprednisolone. NEJM 2013;369:1598.
36. Adunsky. MK-0677 after hip fracture. Arch Gerontol Geriatr 2011;53:183. Halted early, CHF signal.
37. Nass. Oral ghrelin mimetic in older adults. Ann Intern Med 2008;149:601.
38. Van Wagoner. Composition of SARMs sold online. JAMA 2017;318:2004.
39. ECRI/ISMP. Unapproved peptide products. Apr 2026.
40. CSPI. Are injectable peptides safe? cspinet.org
41. WADA. 2026 Prohibited List. wada-ama.org
42. USADA. BPC-157: a prohibited peptide. usada.org
43. Time. FDA panel backs compounding peptides. Jul 2026.
44. RAPS. Committee backs controversial peptides. 2026.
45. STAT. Panel okays peptides for compounding. Jul 2026.
46. NBC News. Panel eases peptide limits over FDA objections. 2026.
47. AP. Financial ties among FDA peptide panel members. 2026.
48. Leerink. PCAC vote and telehealth compounding market. 2026.
49. Examine.com. BPC-157 research breakdown. examine.com/supplements/bpc-157
50. Jarry. BPC: no proof required. McGill OSS. mcgill.ca/oss
