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De Simone Formulation

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The De Simone Formulation is a probiotic formula and manufacturing method developed by Claudio De Simone.[1]

The De Simone Formulation has been clinically studied for a variety of health conditions since the 1990s[2] but it has been researched the most for its efficacy in the medical management of chronic intestinal conditions including irritable bowel syndrome (IBS)[3][4] and inflammatory bowel disease (IBD).[5][6][7][8]

Lawsuits

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The De Simone Formulation has been the subject of lawsuits. In the United States, the 4th U.S. Circuit Court of Appeals upheld a false advertising verdict against the makers of the VSL#3 probiotic in February 2021 stating there was enough evidence to support a jury's November 2018 finding that the makers of VSL#3 had quote "reverse-engineered an imperfect copy" of De Simone's signature probiotic formulation that was sold under the brand name VSL#3 through May 2016 after he withdrew from their joint venture, VSL Pharmaceuticals Inc. According to the lawsuit, his departure was as a result of being pressured to substitute cheaper bacteria in the manufacturing process to lower production costs and raise profits.[9] Court action states that De Simone apparently refused.[10] The makers of VSL#3 were ordered to pay De Simone and ExeGi Pharma a combined total of $18 million (USD) in damages.[11][12]

The Court also issued a permanent injunction intended to prevent claims, implied or stated, of continuity between the two different formulations. The court also cited public health and wellbeing concerns, when they blocked the makers of VSL#3 from linking their product with the original De Simone Formulation by referring to clinical studies that were executed using the De Simone Formulation prior to May 2016.[13]

Scientific research

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On August 1, 2019, the American Gastroenterology Association (AGA), the medical association of gastroenterologists in the United States, issued a correction regarding the De Simone Formulation and VSL#3. AGA's correction stated it had referenced studies referenced in its 2019 Technical Review on the Management of Mild-to-Moderate Ulcerative Colitis that were based on the probiotic formulation previously know by the brand name VSL#3 before May 2016, but was now known by the formulation name 'De Simone Formulation'.[14][15]

On January 24, 2022, the European Crohn's and Colitis Organization (ECCO) issued a letter to the editor of Oxford Academic's Journal of Crohn's and Colitis (JCC) stating that as a result of a court injunction, the ECCO must provide a clarification note for changes relating to VSL#3 and the De Simone Formulation in their articles that reference or studied these probiotics.[16]

References

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  1. ^ "De Simone v. VSL Pharms., Inc., Civil Action No. TDC-15-1356 | Casetext Search + Citator". casetext.com.
  2. ^ Cheng, F. S.; Pan, D.; Chang, B.; Jiang, M.; Sang, L. X. (2020). "Probiotic mixture VSL#3: An overview of basic and clinical studies in chronic diseases – PMC". World Journal of Clinical Cases. 8 (8): 1361–1384. doi:10.12998/wjcc.v8.i8.1361. PMC 7190945. PMID 32368530.
  3. ^ Almerigi, Pier Francesco; Menarini, Mauro; Bazzocchi, Gabriele (July 17, 2010). Santoro, Giulio Aniello; Wieczorek, Andrzej Paweł; Bartram, Clive I. (eds.). Pelvic Floor Disorders: Imaging and Multidisciplinary Approach to Management. Springer Milan. pp. 539–543. doi:10.1007/978-88-470-1542-5_74.
  4. ^ Kim, J.; Cho, K.; Kim, J. S.; Jung, H. C.; Kim, B.; Park, M. S.; Ji, G. E.; Cho, J. Y.; Hong, K. S. (2019). "Probiotic treatment induced change of inflammation related metabolites in IBS-D patients/double-blind, randomized, placebo-controlled trial - PMC". Food Science and Biotechnology. 29 (6): 837–844. doi:10.1007/s10068-019-00717-2. PMC 7256134. PMID 32523793.
  5. ^ Lichtenstein, L.; Avni, I.; Ben-Bassat, O. (February 1, 2017). "P478 The current place of probiotics in treatment of pouchitis: systematic review". Journal of Crohn's and Colitis. 11 (suppl_1): S321 – S322. doi:10.1093/ecco-jcc/jjx002.602.
  6. ^ Fedorak, Richard N.; Feagan, Brian G.; Hotte, Naomi; Leddin, Des; Dieleman, Levinus A.; Petrunia, Denis M.; Enns, Robert; Bitton, Alain; Chiba, Naoki; Paré, Pierre; Rostom, Alaa; Marshall, John; Depew, William; Bernstein, Charles N.; Panaccione, Remo; Aumais, Guy; Steinhart, A. Hillary; Cockeram, Alan; Bailey, Robert J.; Gionchetti, Paolo; Wong, Cindy; Madsen, Karen (May 17, 2015). "The probiotic VSL#3 has anti-inflammatory effects and could reduce endoscopic recurrence after surgery for Crohn's disease". Clinical Gastroenterology and Hepatology. 13 (5): 928–935.e2. doi:10.1016/j.cgh.2014.10.031. PMID 25460016.
  7. ^ Rohatgi, Sarika; Ahuja, Vineet; Makharia, Govind K.; Rai, Tarun; Das, Prasenjit; Dattagupta, Siddharth; Mishra, Veena; Garg, Sushil Kumar (December 31, 2015). "VSL#3 induces and maintains short-term clinical response in patients with active microscopic colitis: a two-phase randomised clinical trial". BMJ Open Gastroenterology. 2 (1): e000018. doi:10.1136/bmjgast-2014-000018. PMC 4599154. PMID 26462271. S2CID 16306599.
  8. ^ Karimi, Ouafae; Peña, A. Salvador; van Bodegraven, Adriaan A. (July 17, 2005). "Probiotics (VSL#3) in arthralgia in patients with ulcerative colitis and Crohn's disease: a pilot study". Drugs of Today. 41 (7): 453–459. doi:10.1358/dot.2005.41.7.917341. PMID 16193098.
  9. ^ "IN BRIEF: Supplement makers owe $18 mln for marketing copy as original – 4th Circuit". Reuters.com. February 18, 2021.
  10. ^ "Class Action Accuses Pharma Companies of Secretly Reformulating VSL#3 Probiotics Product". Classaction.org. 26 July 2019.
  11. ^ "ExeGi Wins Court Ruling Against VSL#3®*, Permanent Injunction Blocks False Advertising to Doctors, Consumers". Biospace.com.
  12. ^ "This case involved a dispute between former business partners as to the ownership of a proprietary formulation ("the De Simone Formulation") used in a probiotic previously known by the tradename VSL#3 and now known by the tradename Visbiome. In November 2018, a jury returned a verdict in favor of Plaintiff and Counterclaim Defendant Claudio DeSimone and Plaintiff ExeGi Pharma, LLC ("ExeGi") (collectively, "the De Simone Parties") on all counts against Defendant and Counterclaim Plaintiff VSL Pharmaceuticals, Inc. ("VSL"), Defendant Leadiant Biosciences, Inc. ("Leadiant") and Defendant Alfasigma USA, Inc. ("Alfasigma")" (PDF). Govinfo.gov. Retrieved July 18, 2022.
  13. ^ "ExeGi Wins Court Ruling Against VSL#3®*, Permanent Injunction Blocks False Advertising To Doctors, Consumers". BioSpace.com.
  14. ^ "Correction". Gastroenterology. 157 (3): 903. September 1, 2019. doi:10.1053/j.gastro.2019.07.035. PMID 31377277. S2CID 241186727.
  15. ^ Singh, Siddharth; Feuerstein, Joseph D.; Binion, David G.; Tremaine, William J. (February 12, 2019). "AGA Technical Review on the Management of Mild-to-Moderate Ulcerative Colitis". Gastroenterology. 156 (3): 769–808.e29. doi:10.1053/j.gastro.2018.12.008. PMC 6858923. PMID 30576642.
  16. ^ Peyrin-Biroulet, Laurent; Siegmund, Britta; Danese, Silvio; Hart, Ailsa; Magro, Fernando; Van Der Woude, Janneke; Armuzzi, Alessandro (January 24, 2022). "Letter to the Editor". Journal of Crohn's and Colitis. 16 (11): 1792–1793. doi:10.1093/ecco-jcc/jjab225. PMID 35073577.
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