De Simone Formulation Explained

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

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

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]

Notes and References

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

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