Policy ForumRegulation

Downgrading of regulation in regenerative medicine

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Science  16 Aug 2019:
Vol. 365, Issue 6454, pp. 644-646
DOI: 10.1126/science.aax6184

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  • RE: https://science.sciencemag.org/content/365/6454/644/tab-e-letters
    • Peter Reczek, Executive Director, Standards Coordinating Body for Regenerative Medicine

    To the Editor:

    The 16 August 2019 Policy Forum in Science magazine contains an article by Sipp and Sleeboom-Faulkner entitled "Downgrading of Regulation in Regenerative Medicine". This article rightly points out a growing concern about the regulatory status of an increasing number of product development initiatives aimed at the explosive field of regenerative medicine and the attendant short comings of over zealous exploitation.

    While "regulatory brokerage" and "drug lag" are two of many factors leading to uncertainty in the development of regenerative medicines, these factors are not unique to regenerative medicine nor are they the only useful targets for improving the quality and efficacy of those medicines for patients.

    In 2017, the Standards Coordinating Body for Regenerative Medicine (www.standardscoordinatingbody.org) was formed as an unbiased, not-for-profit organization charged with advancing the quality, efficacy, and innovation of advanced therapeutics in the global setting. Through these efforts, SCB has partnered with international standards development organizations to develop standards that accelerate therapeutic development and regulatory approval while ensuring that safety and efficacy are maintained throughout. In Japan, for example, SCB is working with the industry group, the Forum for Innovation in Regenerative Medicine (FIRM) and the Internationa...

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    Competing Interests: None declared.
  • RE: The scientific effort to establish the safety and efficacy of medical products has to be protected.
    • Sergio Stagnaro, Director, Quantum Biophysical Semeiotic Research Laboratory

    Downgrading of regulation in regenerative medicine is a topic of fundamental importance for public health. In truth, negative examples have already happened in Western countries. Only a few examples: the prescription of statins against CVD and cancer, in individuals negative to Constitution-dependent ATS, Inherited Real Risk, and respectively to Oncological Terrain. Not to mention patients suffering from Co Q10 deficiency syndrome and therefore at risk of rhabdomyolysis.
    What to write about vaccinations against HPV in women without Inherited Real Risk of uterin and / or ovarian cancer?
    Rightly, when regulation does not support the scientific effort to establish the safety and efficacy of medical products, it may be brokered by interest groups, including industry, particular groups of scientists and patients, and policy-makers.
    1) Stagnaro-Neri M., Stagnaro S., Carenza di Co Q10 secondaria a terapia ipolipidemmizante diagnosticata con la Percussione Ascoltata. Settimana Italiana di Dietologia, 9-13 Aprile 1991, Merano. Atti, pg. 65. Epat. 37, 17, 1990.
    2) Stagnaro-Neri M., Stagnaro S., Auscultatory Percussion Coenzyme Q deficiency Syndrome. VI Int. Symp., Biomedical and clinical aspects of Coenzyme Q. Rome, January 22.24, Chairmen K. Folkers, G.L. Littaru, T. Yamagani, Abs., pg. 105, 1990.
    3) Stagnaro-Neri M., Stagnaro S., Sindrome clinica percusso-ascoltatoria da carenza di Co Q10. Medic. Geriatr. XXIV, 239, 1993.

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    Competing Interests: None declared.

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