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Unapproved Cell and Gene Therapies Flood Social Media, Raising Safety Concerns
The Paul-Ehrlich-Institut (PEI), the German authority responsible for the approval and monitoring of biomedical drugs, is warning about a rise in questionable commercial providers offering unapproved cell and gene therapies online. These advanced therapy medicinal products (ATMP), including cell therapies and gene therapies, are being advertised on social media platforms like Facebook, Instagram, and TikTok, often targeting seriously ill patients with promises that lack scientific backing.
The Lure of Unproven Treatments
Internet users are increasingly encountering advertisements for “low-side cell therapy, which should be able to defeat cancer, or gene therapies that are supposed to help against other most serious diseases.” These therapies frequently enough come with a hefty price tag, sometimes costing patients tens of thousands of euros.
Regulatory Scrutiny and Patient Safety
The PEI is responsible for the approval and monitoring of biomedical drugs in Germany, including ATMPs. The European Medicines Agency (EMA) has approved 19 ATMPs, including 16 gene therapies, one cell therapy, and two biotechnologically processed tissue products. however, many more are being advertised without official approval.
The PEI cautions that these unapproved therapies frequently enough lack “resilient scientific evidence of their effectiveness or harmless[ness].” Since these products are not subject to regulatory control,they pose notable health risks,including serious side effects.
The EMA and the national authorities only advise treatment with ATMP that are approved or are administered in the context of approved clinical tests.
From the notification of the Paul-Ehrlich Institute
Identifying Unapproved ATMPs: Key Warning Signs
The Paul-Ehrlich-Institut offers several criteria to help internet users recognize perhaps unapproved ATMPs:
- Lack of Approval: There is no confirmation of market authorization or approval by the EMA or a national authority.
- Unsubstantiated Claims: The seller makes healing promises for serious illnesses without providing scientific evidence.
- High Costs: The therapy involves high costs that are not covered by health insurance.
- “Experimental Therapy”: The seller offers an “experimental therapy” outside of approved clinical trials in exchange for money.
what To Do If You Encounter Suspicious Offers
The Paul-Ehrlich Institute advises patients who encounter relevant offers on the internet to seek detailed advice from a specialist before buying. Patients should also coordinate with their health insurance to determine coverage for the therapy.
Anyone who believes they have come across a fake drug online should report their suspicions to the state authority responsible
