STATEMENT BY SENATOR, THE HON. DR. MARCUS BETHEL
ON THE MINISTRY OF HEALTH"S INVESTIGATIONS INTO STEM CELL RESEARCH ON GRAND BAHAMA

The Bahamas Journal published two articles dated 8th and 9th July, 2004, which reported that an exclusive investigation conducted by that publication revealed that experimental stem cell treatments are being performed at the Immunology Research Centre (IAT) in Freeport, Grand Bahama. It has also been reported that these cells are being collected from umbilical cord blood of mothers giving birth at the Rand Memorial Hospital.

The report indicated that officials at the Rand Memorial Hospital were unaware of any such arrangements and insisted that the hospital"s nursing staff were well aware of the procedures that should be followed, and the necessary approval required

The Minister of Health immediately requested an investigation of the report that experimental stem cell treatments were being performed at the Immuno Augmentative Therapy (IAT) Research Centre, (Bahamas) Ltd. in Freeport, Grand Bahama, and that component of the report noted in particular that these cells are being collected from umbilical cord blood of mothers giving birth at the Rand Memorial Hospital.

The Results of the Investigation revealed the following:

The Ministry of Health of The Bahamas has not approved any such procedures, nor granted any approval for stem cell research or treatments in The Bahamas. Dr. John Clement who is a licensed by the Medical Council of The Bahamas and a practitioner in Grand Bahama, had admitting privileges at the Rand Memorial Hospital in Freeport Grand Bahama.

The Ministry of Health had not received an application from Dr. Clement to conduct this research. Therefore, the Ministry of Health gave no approval for this research activity. The process of approval to conduct research requires an applicant to apply to the Ministry of Health and submit a complete proposal that is then reviewed by the Ethics Committee, of the Ministry of Health that then makes a recommendation to the Minister of Health.

Further investigations revealed that the Immunology Research Centre is not licensed by the Hospitals and Health Care Facilities Licensing Board as a Haematology and Oncology Clinic to perform these procedures. The Hospitals and Health Care Facilities Regulations, Part VII, require that every licensee of a health care facility that is licensed as a Haematology and Oncology clinic shall be under the direction of a medical practitioner with specialty training in oncology, and shall have on staff, registered nurses with specialty training in medical oncology.

The Regulations further specify guidelines for referral to the Haematology and Oncology clinic, as well as the protocols to be followed with respect to removal of tissue from patients in such clinics. Additionally, the regulations require that every Haematology and oncology clinic shall be linked to the Cancer Registry of the Princess Margaret Hospital so that the treatment protocol can be reviewed and monitored by the Hospital"s Tumour Board.

Such facilities are also required to have a quality control programme approved by the Board that covers all the types of analyses performed by the laboratory.

The regulations outline the scope of the tests to be performed as well as the qualifications of staff to perform such tests. The Health Care Facilities and Licensing Board has advised that I.A.T. facility did not meet the standards for licensing as a laboratory, and there are no persons on staff licensed by the Health Professions Council, who qualify to perform the procedures.

Prior to the appearance of the newspaper article of The Bahama Journal, the Executive Management Committee (E.M.C.) of the Rand Memorial Hospital, Grand Bahama was not aware of Dr. Clement"s research involving the collection of cord blood samples at the Rand.

The Executive Management Committee reports that Dr. Clement has not received written or expressed permission to secure patients" blood samples from any member of the Grand Bahama Health Services.

The Medical Records Manager reviewed records and delivery reports, and there is no documentation on the records of maternity patients that approval was granted to participate in the study. There is no record of funds received. It is reported that six mothers may have participated in the study.

Following the investigation by the Rand Memorial Hospital, Dr. Clement has been advised that he is no longer to procure blood samples from any patient at the Rand Memorial Hospital for stem cell research or treatment. Secondly, all clinical staff of the Rand Memorial Hospital have been reminded via verbal and written communication that they are not to participate in any unauthorized research and advised of potential consequences if they have not received consent from the Executive Management Committee.

Thirdly, all physicians who appeared on the physician list for admitting privileges at the Rand are requested to complete a revised application for admitting privileges and provide an updated curriculum vitae with copies of a current medical licence and malpractice insurance and to be sent to the Executive Management Committee.

Fourthly, the Medical Advisory Committee is working along with the Co-Director of the University of Miami"s Ethics Programme to assist the Rand
Memorial Hospital with providing guidelines to its Ethics Committee.

Fifthly, specific criteria and guidelines for all research undertaken in Grand Bahama will be developed and disseminated by the research arm of the Education and Research Committee, Rand Memorial Hospital.

Further sensitization through seminars/workshops of all clinical staff as to the medical, ethical and legal implications of participating in research will be scheduled for the staff of the Grand Bahama Health Services.