Pamlab Explained

Alfasigma USA, Inc. (formerly Pamlab) is an American medical food company, and a division of Alfasigma Group, of Bologna, Italy.

Alfasigma's base of operations is located in Bedminster, New Jersey.

History

The company entered the pharmaceutical industry in 1957, initially introducing prescription cough/cold products. In 1987, Pamlab was purchased by Samuel and Judith Camp.[1]

In early 2013, Pamlab was purchased by Nestlé Health Science.[2]

In December 2016, Pamlab was purchased by Alfasigma Group of Bologna, Italy.[3]

Legal actions

Alfasigma USA, Inc. was sued by ExeGi Pharma LLC and the Italian inventor of probiotic VSL#3, Claudio De Simone, for making false advertising claims and ownership rights to VSL#3.[4] [5] [6]

According to court documents: "Defendant VSL Inc., and its licensees Alfasigma and Leadiant, having lost the right to sell the De Simone Formulation, decided to manufacture, market, and sell a different, inferior formulation (the “Fraudulent Formulation”) without conducting any tests to determine if the Fraudulent Formulation would be efficacious in any way".  

A scientific article published in Frontiers in Immunology concluded: "These discrepancies may have a major impact on patient safety and on the liability of doctors when they prescribe a probiotic formulation made with different processes at different production sites from the formulation, which generated the original evidence, without properly informing the patients".[7]

A class action related to the VSL#3 scandal was recently opened in the USA.[8]

Products

Alfasigma USA, Inc. produces medical foods for people with diabetic peripheral neuropathy, early memory loss/Alzheimer's, high-risk pregnancy, depression, and other medical conditions.

Some of Alfasigma USA's products include the following:

See also

External links

Notes and References

  1. Web site: Our History. Pamlab. 2016-03-24.
  2. Web site: Nestle buys U.S. medical foods firm Pamlab. Reuters. 26 February 2013. 2016-03-24.
  3. Web site: Alfasigma Expands Footprint. 13 January 2017. 18 July 2017. 22 December 2018. https://web.archive.org/web/20181222232036/http://www.alfasigma.com/CMSContent/Alfasigma/News/01%20news_sito_alfasigma_ING.pdf. dead.
  4. Simone. C. De. 2018. Letter: what gastroenterologists should know about VSL#3. Alimentary Pharmacology & Therapeutics. 47. 5. 698–699. 10.1111/apt.14515. 29417631. 1365-2036. free.
  5. Web site: De Simone v. VSL Pharmaceuticals, Inc. et al, No. 8:2015cv01356 - Document 927 (D. Md. 2019). Justia Law. en. 2019-09-01.
  6. News: Class Action.
  7. Trinchieri. Vito. Laghi. Luca. Vitali. Beatrice. Parolin. Carola. Giusti. Ilaria. Capobianco. Daniela. Mastromarino. Paola. De Simone. Claudio. 2017-11-06. Efficacy and Safety of a Multistrain Probiotic Formulation Depends from Manufacturing. Frontiers in Immunology. 8. 1474. 10.3389/fimmu.2017.01474. 1664-3224. 5681494. 29163538. free .
  8. Web site: Class Action Accuses Pharma Companies of Secretly Reformulating VSL#3 Probiotics Product. www.classaction.org. 26 July 2019 . en. 2019-09-01.