Stem cell vs. regenerative research?

By Dave Kaiser
Stem cell research programs and treatments are always controversial; however, St. Kitts and Nevis medical community, researchers, businessmen and government officials recently ignited a fire-storm that endangered at least one medical tourist’s life when the regenerative research program came to an abrupt halt.

Details about a revised and active regenerative research project were revealed last week when Chief Medical Officer (CMO) Dr. Patrick Martin discussed the project right before being sent on pre-retirement leave after passing 55, the mandatory retirement age of civil servants. Shortly after Martin’s resignation, Minister of State with responsibility for Heathcare, Wendy Phipps, denied stem cell research was underway, calling it a regenerative medicine project using plasma-based infusion therapies.

The program was criticized right away by a variety of detractors, including former Prime Minister Prime Minister Denzil Douglas, who voiced disappointment that the stem cell program he proposed had been deserted.

On Wednesday June 29 during his monthly press conference, Prime Minister Dr. the Honourable Timothy Harris, criticized Douglas and other detractors of the regenerative medicine project as “fear-mongers, acting at the highest level of irresponsibility.”

“[Former Prime Minister Minister] Denzil Douglas has no moral minimum and there is no low too low for him to go,” Dr. the Honourable Prime Minster Harris said. “In order to destabilize the country with the hallucination that he can get back in [office]. It will not happen because the people of St. Kitts and Nevis will not return to the rejects.”

Prime Minister Dr. the Honourable Timothy Harris criticized complainers as, “wanna-be doctors and politicians who are inexperienced and do not understand the first call should be to save lives.”

“My government prides itself in doing the right things, the right way, and at the right time,” Dr. the Honourable Prime Minster Harris said. “We give premium attention to doing this. Indeed it is because we love doing things right, but some criticize us of being tardy, because we are not rushed, consultations are important, although they come with a price if they are going to be time consuming if they are going to be meaningful.”

The Prime Minister said before he considered entry into medical tourism and regenerative medicine in particular, he discussed the pros and cons with experts and obtained opinions with informed consultations.

“I want to make it clear that this government did its due diligence; we sought advice far and near,” Dr. the Honourable Prime Minster Harris explained. Every entity with which we consulted supported our thrust into regenerative medicine. They told us it was the only wave of the future.”

“We never hurried into implementing the arrangements left behind by the rejected Douglas regime,” Dr. the Honourable Prime Minster Harris said. We sought competent and independent advice from the health fraternity in the Nevis Island administration and at the Federal level. We sought independent and objective advice from the members of the Medical Board.”

In the end Dr. the Honourable Prime Minster Harris said he was persuaded the country and its people will benefit from a well-organized program for regenerative medicine, one of the fastest-growing areas of medical provision. He said the new year will bring new skill sets and a range of support systems and institutions to St. Kitts and Nevis while also bringing people of high net worth to the country.

“This will translate into more jobs, higher incomes and economic opportunity to all the people of the Federation,” Dr. the Honourable Prime Minster Harris said. “At the same time it will let this country contribute to global demand for such medical services. Indeed, we are making contributions to the finest facilities that are here doing high-quality research in Parkinson’s Disease, in reproductive systems and other ailments.”

The Prime Minister predicted regenerative research will provide many Nevisians to engage in science.

“Equally we took into account the high level of non-communicable diseases in our region,” Dr. the Honourable Prime Minster Harris explained. “There is a distinct possibility to offer therapies at affordable costs right here in St. Kitts and Nevis to assist our people who struggle every day with diabetes, hypertension, spinal cord injuries, stroke and other ailments.”

He said all of these were factored into his informed decision-making.

The PM said that before the commencement of regenerative therapy the Hon. Wendy Phipps and her staff met with Dr. Cameron Wilkinson and representatives of the regenerative therapy staff to discuss the entire process, the protocols, the do’s and don’ts and expectations of everyone involved with the project.

He said having such a successful program will provide a great opportunity for medical tourism.

“Ask yourself; was this hue and cry over regenerative medicine necessary?” Dr. the Honourable Prime Minster Harris asked. “The resounding answer is no. It is false and lies at work because when you take into account that the Opposition government had agreed to pursue regenerative medicine would they have heard the noise?”

“This government said no to the kind of stem cell engagement which Douglas had proposed. We were pressured by entities who said they had an agreement with former Prime Minister Douglas to do stem cell research and we said embryotic research will not survive here.”

Background information

More than two years ago, the Federation’s Chief Medical Officer Dr. Patrick Martin revealed details about a stem cell research project and submitted them for consideration by government regulatory agencies. After fine-tuning by medical experts, the project outline went to then Prime Minister Denzil Douglas and was later approved by the St. Kitts and Nevis Cabinet.

“Government has given approval to a research project involving the use of plasma-based infusion therapies, to a limited number of overseas patients. The project, as approved, will not extend to any residents of St. Kitts and Nevis. It is a Phase 2-staged Clinical Trial of a research initiative that has already received US Food & Drug Administration (FDA) level one approval,” Minister Phipps explained.

Free-for-all results

Since then, the topic has evolved into a free-for-all involving protestations by former Prime Minister Denzil Douglas and the Labour Party, suggesting that Prime Minister Dr. the Honourable Timothy Harris should resign his post. At the same time there were resignation calls for Health Minister Eugene Hamilton.

The stipulation that doctors, researchers and legislators avoid profiting from the research program did not stop opportunists and stem cell entrepreneurs from attempting to position themselves in key roles in the future.

CMO Acting Chief Comments

Thursday, Dr. Cameron Wilkinson, acting CMO and chief of staff at St. Kitts Joseph N. France (JNF) General Hospital, upheld the stem cell research program, saying it could help patients with a wide variety of ailments including spinal cord injuries, Type I Diabetes, and osteoarthritis.

“The next chapter of medical research will use stem cells instead of donated organs,” Dr. Wilkinson said. He described embryonic stem cells, those found in the early embryo.

“Medical studies of tissue stem cells, which are found in our bodies all our lives, have been going on for more than 60 years,” he explained. Tissues in the human body are maintained and repaired throughout life by stem cells, which are very different than embryonic stem cells.

The latest use of these techniques involves induced pluripotent stem cells. Although similar to embryonic stem cells these are made from specialized adult cells using a laboratory technique discovered in 2006, and less controversial.

Pioneering research on blood stem cells has been on ongoing for 60 years with stem cell therapy, such as bone marrow transplants able to replace a patient’s diseased blood system for life.

Basics determined a year ago

Dr. Wilkinson confirmed that more than a year ago the Federation’s medical body supported the establishment of an adult regenerative stem cell program. He pointed out the decision was based on:

Providing economic benefit to the island from medical tourism; and
Rely on the Medical Board for advice about the best direction forward to ensure the program was safe, ethical and successful.
He said pursuant to the Medical Act a medical board was established to regulate certain categories of practitioners. Dr. Wilkinson emphasized this board had no authority to provide medical advice about advancements to the St. Kitts and Nevis government. Board members would be asked their opinion about initiatives and if they agreed upon their utility would support them.

It was emphasized that no entity would have (financial) gain from the initiative and it was approved by the Cabinet.

Dr. Wilkinson said three rooms in JFN would be allocated to the research. The research would only involve foreign patients enrolled in the study without any plans to have local participants.

Dr. Wilkinson indicated that communications weaknesses in the program came to a head on June 13 when, while during an operation, he received a call saying a patient enrolled in the research was being moved to a regular hospital ward while the program was halted.

According to Dr. Wilkinson, the decision ignored established procedures and concerns about the patient’s well-being.

“The Chief Medical Officer has the authority to consult with the executive management committee individually or collectively on matters that pertain to the delivery of quality medical and health services,” Dr. Wilkinson said. “The CMO [Dr. Martin] did not consult any member of the executive board.”

Dr. Wilkinson said Dr. Martin was well aware of the research taking place and that it was authorized.

When Dr. Wilkinson became aware of the situation, he said, “It was handled as I would have dealt similar matters in the past. I gave the authorization for the procedure to continue with the best interest of the patients in mind. I could not recklessly stop the treatment mid-stream and allow the patients to suffer. As physicians, we are guided by the principle of first, do no harm.”

Dr. Wilkinson later informed junior and senior Ministers of Health who sanctioned his decision.

The implementation of this program would provide numerous economic benefits to St. Kitts and Nevis universities and colleges offering medical and health science programs; medical tourism benefits, including the establishment of health centres and related tourism; and low-cost medical care, often estimated at as much as 98 percent lower than in other countries. Such programs have already been successful in other Caribbean countries such as the Bahamas, and Jamaica.

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