ISLAMABAD-‘Pakistan Blood and Marrow Transplant (PBMT) Group’ – a forum of professionals and scientists in Pakistan involved in clinical blood and marrow transplantation and related cellular therapies – and the Pakistan Society of Haematology (PSH) have jointly raised serious concerns over what they called illegal practice of stem cell therapy and the way regenerative medicine centers are administering non-FDA, non-NBC-approved stem cell products in Pakistan.
The Group and the Society comprises cellular therapy and stem cell transplant experts from all over Pakistan with decades of experience at home and abroad. In a joint letter to the federal ministry of health, a copy of which is exclusively available with The Nation, both the medical bodies observed that these so-called centers offering stem cell therapy, are giving non-FDA-approved treatment without regulatory approval in Pakistan. FDA is the ‘Food and Drug Administration’, a federal agency of the Department of Health and Human Services of the United States while NBC stands for National Bio-ethical Committee.
“The treatment offered doesn’t have a scientific proof of their efficacy and can cause serious side effects like bacterial infection, hepatitis, HIV, potential for cancer,” read the letter. It further said, “The non-FDA-approved stem cell treatment can only be offered as a part of clinical trial duly approved by NBC and its current use amounts to illegal and corrupt practice”.
The professionals demanded that all proposals involving stem cells of any source for research or non-approved therapy should be cleared by Human Organ Transplant Authority (HOTA) Sub-Committee, through the National Bioethics Committee.
Urging the regulatory bodies to take appropriate action to stop this ‘corrupt’ practice, they said, “All centers performing stem cell research and therapy should be registered with the HOTA for accreditation, on the basis of their technical competence (in stem cell collection procedures, enumeration, cryo preservation, stem cell viability studies) and ethical review and oversight procedures”. In Pakistan, National Bio-ethical Committee (NBC) and Human Organ Transplant Authority (HOTA) are regulatory authorities to safeguard the rights, safety and wellbeing of patients.
The professionals believes that over the last few years, different centers in large cities of Pakistan were offering stem cell therapy for different diseases like hair fall, dementia, muscular dystrophies, infertility, autism and numerous other disorders. “These centers portray stem cell therapy as the last hope and only chance of cure, luring patients to receive this extremely expensive experimental treatment which is neither approved in Pakistan nor elsewhere in the world. “This raises serious safety, ethical, scientific and legal concerns,” the experts told the ministry of health.
The letter said that more than 1000 clinical trials worldwide are currently being carried out to see the clinical efficacy of stem cell therapy. Most of the previously conducted trials produced negative results and failed to achieve regulatory approvals.
The letter quoted the world’s largest drug regulatory body, the United States Food and Drug Administration (US FDA) as having stated, ‘’Currently, the only stem cell treatments approved by the Food and Drug Administration (FDA) are products that treat certain cancers and disorders of the blood and immune system (CAR-T cell therapy and gene therapy). “If the products are being used for arthritis, injury-related pain, chronic joint pain, anti-aging or other health issues, they have not been approved by FDA and are being marketed illegally.”
Speaking to this scribe, President PBMT Group, Prof. Parvez Ahmed said that the therapy was never recognized in Pakistan by the regulatory bodies and even not duly verified by the Drug Regulatory Authority Pakistan (DRAP). He said different organizations invite people in the name of ‘sole cure’ for diseases like cancer and bone marrow failures but, he added, it can have long term side-effects.
Prof. Pervez warned that such a practice in Pakistan is not only illegal but also immoral on the grounds of having no credibility, oversight and approval. He was of the view that the government should come forward to stop this illegal act at the earliest.