Category ETHICS INFORMATION

PIER MARIA FORNASARI
2022-05-06

Inspection at the IHU-Méditerranée Infection and the AP-HM: the French National Agency for Medicines Safety (ANSM) takes legal action again and initiates administrative proceedings

ANSM is publishing the final reports of the inspection conducted at the Institut hospitalo universitaire-Méditerranée Infection de Marseille (IHU) and at the Assistance Publique – Hôpitaux de Marseille (AP-HM), following reports in the context of our whistleblower system. The inspection reveals serious shortcomings and non-compliances with the regulations for research involving the human person (RIPH) , in particular

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PIER MARIA FORNASARI
2022-02-17

Creating universal blood-type organs for transplant

A study published in Science Translational Medicine performed at the Latner Thoracic Surgery Research Laboratories and UHN’s Ajmera Transplant Centre has proved that it is possible to convert blood type safely in donor organs intended for transplantation. This finding is an important step towards creating universal type O organs, which would significantly improve fairness in organ allocation

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No Comments InCLINICAL TRIALS
PIER MARIA FORNASARI
2021-11-20

Harms Linked to Unapproved Stem Cell Interventions Highlight Need for Greater FDA Enforcement

Unproven regenerative medical products have led to infections, disabilities, and deaths Stem cell products and other regenerative therapies have significant potential to treat traumatic injuries and serious diseases. Although some have earned approval from the Food and Drug Administration, most have not, and many of these unapproved interventions have led to life-threatening infections, chronic pain,

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No Comments InUNPROVEN THERAPIES
PIER MARIA FORNASARI
2021-11-12

Study reveals tactics used by US stem cell clinics to market their treatments

Stem cell clinics continue to thrive in the US and worldwide, building their business on misleading advertising and offering unapproved and unproven stem-cell-based interventions (SCBI). A research recently published in Stem Cell Reports by Emma Frow, David Brafman, and colleagues from Arizona State University, asked what kinds of claims and evidence these clinics use to market their

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PIER MARIA FORNASARI
2021-11-04

The American stem cell sell in 2021: U.S. businesses selling unlicensed and unproven stem cell interventions. Ethical issues and misinformation linked to overhyped science.

In March 2021, 1,480 U.S. businesses operating 2,754 clinics were found selling purported stem cell treatments for various indications. More than four times as many businesses than were identified 5 years ago are selling stem cell products that are not FDA-approved and lack convincing evidence of safety and efficacy following a new paper published in Cell

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No Comments InUNPROVEN THERAPIES
PIER MARIA FORNASARI
2021-10-22

How to identify misleading information and fake news in scientific communication

A guide to to determine if something is pseudoscience or real science Click the link Your first exposure to any pseudoscientific claim will almost certainly come in the form of a catchy headline—perhaps a little too catchy. John Gregory, a researcher for the online fact-checking service NewsGuard, warns that fully capitalized words, exclamation points, or strong

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PIER MARIA FORNASARI
2021-10-06

Internet hawkers of stem cell therapies for ocular diseases

Patients have been blinded or have experienced retinal detachments after treatment with so-called stem cell therapies such as intravitreal injections of autologous stem cells that are not FDA approved for many ocular conditions across the US and that were marketed directly to patients. Currently, the FDA has regulatory authority over such companies and since June

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No Comments InUNPROVEN THERAPIES
PIER MARIA FORNASARI
2021-10-06

Unapproved Stem Cell Therapies Harms Highlight Need for Greater Regulatory Enforcement

Unproven regenerative medical products have led to infections, disabilities and deaths Overview Stem cell products and other regenerative therapies have significant potential to treat traumatic injuries and serious diseases. Although some have earned approval from the Food and Drug Administration, most have not, and many of these unapproved interventions have led to life-threatening infections, chronic

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No Comments InUNPROVEN THERAPIES
PIER MARIA FORNASARI
2021-01-25

The effects of armed conflict on the health of women and children. More than 10 million deaths in children <5 years can be attributed to conflict between 1995 and 2015 globally.

Women and children bear substantial morbidity and mortality as a result of armed conflicts. This paper published in The Lancet focuses on the direct (due to violence) and indirect health effects of armed conflict on women and children (including adolescents) worldwide. It was estimate that nearly 36 million children and 16 million women were displaced

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