The European Medicines Agency, EMA, and Heads of Medicine Agencies, HMA, warn of illegal drugs for advanced therapy, ATMP, offered to patients in the EU.
ATMP involves drugs based on genes, tissues or cells. When these drugs are approved through EMA or by a national authority, they can offer important treatments for patients, writes Swedish The Swedish Medicines Agency.
However, there is a plethora of unapproved ATMPs on the Internet, which is then not only illegal – but also dangerous. The warning includes so -called “dendritic cell therapies” against cancer, which is a form of therapy that activates the immune system against cancer cells.
Marketed on social media
The therapies are usually marketed on websites and social media by a number of individuals, companies and clinics. They are often described as “a final jump”, to exploit patients ‘and their families’ concerns.
“They can expose patients to risks and cause serious side effects, without providing promised improvement/effect,” the Swedish Medicines Agency writes.
“Authorities across the EU are cooperating to stop those who provide these unapproved and illegal ATMPA products. The public is invited to report suspected cases to their national competent authorities, that is, to the Swedish Medicines Agency in Sweden, ”the authority writes further.
Warning signals
The Swedish Medicines Agency lists warning signals that may indicate that the treatments offered online are both illegal and dangerous:
“The supplier markets the product as experimental but it is used outside an approved clinical trial. Often, the product is referred to as’ alternative ‘or’ natural ”.
“The supplier cannot confirm that the product’s use has been approved through EMA. There is usually little or no evidence that these products are effective for cancer treatment ”.
“The alleged treatment effect is superior to the currently approved treatments (if available), and is not documented in medical literature”.