European medicines regulators are warning people against shady clinics and companies that promise miracle cures for cancer and other conditions amid reports that unproven treatments are being offered in several countries.
The warning from the European Medicines Agency (EMA) and national-level regulators focused on groundbreaking new treatments that use genes, tissues, or cells, such as gene therapies or so-called cancer vaccines.
Within the European Union, these drugs – known as advanced therapy medicinal products (ATMPs) – can only be offered to patients if they have been authorised by the EMA, if they are being given as part of a clinical trial, or if a national agency has given special permission.
But lately, several clinics and companies have been marketing them directly to patients without evidence that they work or are safe – and without approval from regulators, according to the EMA.
The agency specifically called out dendritic cell therapies, which can be used to activate the body’s immune system to attack cancer cells and are part of a class of treatments commonly called cancer vaccines.
The potentially illegal therapies are often advertised online or on social media “as a last hope, exploiting the worries of patients and their families,” the EMA said.
Because there is no official oversight for these drugs, the agency added, they may be contaminated, inconsistently made, or poorly stored – and even cause serious side effects without boosting patients’ health.
“Patients may also face substantial financial costs and emotional distress from ineffective or harmful treatments,” the EMA said.
Regulators working to ‘clamp down’ on unproven treatments
It’s not the first time the agency has warned patients against possible medical scams.
In 2020, it said people should be sceptical of hospitals and companies pushing unproven cell-based therapies for cancer, cardiovascular diseases, autism, cerebral palsy, muscular dystrophy, and vision loss.
Recently, regulators’ concerns have been “reignited by recent cases where such unproven therapies have been directly offered to patients in several European countries,” an EMA spokesperson told Euronews Health.
The spokesperson cited an international investigation published last year into a Spanish company that made millions of euros by selling illegal dendritic cell treatments to hundreds of cancer patients across Europe.
The agency urged people to report anyone selling underground treatments to their national authorities and said it was working with the police in several countries to “clamp down” on them.
There are several warning signs that a drug is unregulated, the EMA said, including a company or clinic labeling it as “experimental” but offering it outside of a clinical trial, refusing to confirm whether it has been authorised, or touting benefits that aren’t backed up by medical research.
The bottom line, the EMA said: “Beware of treatments advertised online and on social media”.
