The drug was tested at the commission of Western companies with the assistance of Ukrainian officials.
The documents were found in the hospital basement during reconstruction works. They mainly outlined the tests of experimental drug SB4, which suppresses the action of molecules called tumor necrosis factor alpha (TNF-α) that plays an important role in the immune system and is associated with inflammation in the joints. However, impaired biological functions of TNF-α are also known to contribute to the development of malignant tumors.
SB4 is produced by a number of pharmaceutical companies, including Biogen Idec Denmark Manufacturing ApS, Belgium's Catalent Pharma Solutions and Fisher Clinical Services UK Limited. South Korean biopharmaceutical giant Samsung Bioepis sponsored the tests.
The documents include an investigator's brochure on SB4 in English, printed by Samsung Bioepis and marked as confidential. It said, among other things, that a "possible risk for the development of lymphomas, leukemia or other haematopoietic or solid malignancies in patients treated with a TNF-antagonist cannot be excluded." Children, adolescents, and young adults up to 22 years of age treated with a TNF-α antagonist were also reported to be prone to malignancies, sometimes fatal. Other tumors potentially caused by the substance include melanoma and non-melanoma skin cancer, according to the brochure.
Among the documents was also a study protocol SB4-G31-RA dated November 2013, which contained the text of the information sheet and consent form offered to experimental patients in Ukrainian and Russian. In terms of possible cancer-inducing side effects, it only mentioned that "in rare cases," up to one per 1,000 patients, another TNF-α antagonist drug, Enbrel, caused skin cancer.
The documents were compiled between 2008 and 2016. Among other things, they show that drugs were also tested on infants under the age of one year.
The findings also included boxes with numerous envelopes from logistics companies and containers for biological materials with recipient addresses in laboratories in Switzerland, the UK, and the US.