Basseterre, St. Kitts & Nevis June 29, 2016-—- In relation to the JNF Stem Cell/Regenerative Medicine matter, certain unfavourable statements have been made about me and my tenure in office. These statements affect me as a citizen with constitutional protections, my public service, and my livelihood as a health professional.
After speaking with the media on Friday June 24, it was my intention not to make any further public statements since I was about to seek legal advice. However, certain public statements made on June 29th have compelled me to temporarily break my media silence.
1. At the outset, I wish to thank all well-wishers for their overwhelming outpouring of support and concern. I wish also to thank the Ministers of Government who have publically commented on my tenure as CMO using terms such as “exemplary” and “professional”. For this I am grateful.
. Globally, Human Health, Animal Health and Environmental Health are inter-connected under an area of work called “One Health”. The Federation is already well-regarded as a center for high quality primate research, as well as veterinary and medical education. Over the years, my views on Medical Tourism and the potential of Regenerative Medicine/Stem Cells have been documented in correspondence to Ministers, Permanent Secretaries, and professional colleagues, as well as in media interviews. Therefore, I reiterate my full support for the Federation being positioned as a center for medical innovation including Regenerative Medicine/Stem Cells, subject to ethical and legal safeguards.
3. I am reliably informed that during the Prime Minister’s press conference of June 29, email correspondence between Dr. Gene Redmond of St. Kitts Biomedical and myself was read and commented upon. This email exchange was copied to members of the Medical Board. The full text of the email exchange accompanies this document.
4. The JNF Regenerative Medicine/Stem Cell activity involving Human Umbilical Cord Blood Plasma was not sanctioned on legal and ethical grounds. No law governing such activity has been enacted in the Federation.
5. Ethical sanctioning of health research is the remit of the Office of the CMO consistent with the Public Health Act and international conventions governing health research. The Federation is party to these conventions by virtue of its membership of the United Nations, PAHO/WHO and CARPHA.
6. No protocol of a Phase 2 clinical trial involving Human Umbilical Cord Blood Plasma was submitted to the Office of the CMO prior to my being sent on pre-retirement leave on June 16th. A few days ago, I received a document entitled “Infusion Protocol For Human Umbilical Cord Blood Plasma”. This document appears to speak to the JNF Regenerative Medicine/Stem Cell activity.
7. In the Infusion Protocol, there is no mention of the activity being a phase 2 trial and no mention of the sponsor seeking and receiving ethical approval. The word “Nygard” is emblazoned on the cover page. On pages 2 and 12, the “Responsible Party” is identified as the “Advanced Institute of Regenerative Medicine”, Zenway Blvd, Frigate Bay, St. Kitts. On page 12, the “Principal Doctor” is identified as “Lagrotta, S. MD”. On 13 June 2016, this doctor was found in the JNF Private Ward in scrubs (a form of medical attire), with a stethoscope around her neck, and wearing gloves. She was integrally connected to the Regenerative Medicine/Stem Cell activity. She was not registered (i.e. not listed in a register) and not licensed (i.e. not certified) to practice medicine in the Federation. Section 27 of the Medical Act was invoked. It speaks to “Offenses by unregistered persons”. Accordingly, the doctor was asked to cease and desist, and to leave the premises.
8. Human Umbilical Cord Blood Plasma is believed to stimulate a person’s own stem cells which in turn can repair damaged cells, tissue and organs.
\9. United States FDA-approval, if it exists, is not a licence to conduct research in the sovereign state of St. Kitts and Nevis. The FDA maintains a registry of research projects submitted for its approval. The related website is Clinicaltrials.gov. At the time of writing, nothing was found under the search phrase “Human Umbilical Cord Blood Plasma Phase 1” undertaken by the responsible party named in para 7.
10. Human Umbilical Cord Blood Plasma is a medical product. All imported products, medical or otherwise, must be declared to Customs. If a product is to be exempted from border tariffs, Customs will receive correspondence to that effect. When medical products are unknown to Customs, or are of a suspicious nature, Customs usually consults with the Office of the CMO or designees for a recommendation. It is yet to be disclosed whether or not the imported plasma was declared to Customs.
11. This Federation is a nation of laws and, notwithstanding its small size, is a member of the international community of law-abiding nations. The powers, duties and functions to promote or preserve health are vested in the Minister of Health by the Public Health Act (Section 3). Section 3 (a) states that such powers, duties and functions include “the prevention, treatment, limitation and suppression of disease including the conduct of investigations and inquiries in respect there of:” The conduct of investigations includes the conduct of surveillance and research. This is affirmed by PAHO/WHO which has established a list of “Essential Public Health Functions necessary to strengthen public health practice”. These functions are described as fundamental obligations of a State. Surveillance and research are so listed.
12. Section 7 provides for a Chief Medical Officer of the State. Section 8 provides for the delegation of the Minister’s powers to the CMO and other officers, “except where the Minister may otherwise direct”. The Minister is the substantive Minister of Health. The Office of the Permanent Secretary is not mentioned in the Public Health Act. Under the Constitution, a PS is the administrative head of a ministry. There is a Ministry of Health in each island. Under the Public Health Act, the CMO is the lead officer in scientific and technical aspects of public health practice in the Federation.
13. The Medical Act is in the name of the Minister of Health. The Act provides for a Medical Board to assess qualifications and to determine who is “fit and proper” to practice medicine, dentistry, pharmacy, chiropractic and optometry. The Medical Act provides a formula for the Minister to appoint members each for a two-year term. Members were reappointed by instrument effective 1st January 2015. They were Drs. Patrick Martin (Chair), Mervyn Laws, Cameron Wilkinson, Derrek Jeffers, Bichara Sahely, and Randy Liburd. Instruments of appointment are signed by a Minister.
14. As a collective, the Medical Board did not approve a specific Regenerative Medicine/Stem Cell project because it has no such authority under the Medical Act. Such was said to the Permanent Secretary and the Ministers.
15. Nothing in the law, regulations or public service code subordinates the Office of the CMO to another medical officer in the public service.
16. In essence: The JNF Regenerative Medicine/Stem Cell activity was just that. The activity was not sanctioned, ethically and legally. I found out about the plasma activity on June 13, 2016. The principal doctor was not registered and licensed to practice in the Federation. The laws of the Federation were violated. The laws were upheld by the Office of the CMO, pursuant to duty.
17. Matters pertaining to my retirement will be addressed separately.