Thursday, July 7, 2016

Western Indies - Stem Cell Controversy: Unanswered Questions

St. Kitts and Nevis (WINN):  A week after controversy erupted over a regenerative medicine project at the JNF hospital, there are still unanswered questions about whether there was a breach of protocol in setting up the initiative, and who is running the show.

What is clear a week later however is that legislation governing experimental research therapy such as the one being conducted at the JNF is not yet in place; the government has acknowledged this, and has indicated that it is being prepared.

Another debate that has raged all week about whether the research is a stem cell project seems to be somewhat reluctantly settled. 

Despite initial efforts to suggest otherwise and label it otherwise, it has been confirmed that the research, while it reportedly does not involve the introduction of stem cells into the patient, is designed to stimulate stem cell growth.

Retiring Chief Medical Officer Dr. Patrick Martin has come in for heavy fire from the Junior Minister of Health and the Prime Minister for referring to the project as a stem cell initiative.  Initially the Junior Minister of Health Senator Wendy Phipps vehemently denied that the research was a stem cell project.

“As Minister of State with Responsibility for Health I wish to state categorically that neither the Ministry of Health nor the JNF General Hospital is engaged in any stem cell project…it is extremely unfortunate that Dr. Martin has sought to link his retirement to alleged stem cell research when he knows that there is no stem cell research currently occurring in the Federation.”

In a statement issued Wednesday, St. Kitts Biomedical President Dr. Eugene Redmond backed the government’s claim, categorically dismissing the charge that the JNF project employs the use of stem cells.

“This treatment did not involve stem cells whatsoever.  The fact that it has become a stem cell controversy is…based on total misinformation,” he said in the statement.

According to Dr. Redmond, the experimental treatment involves the intravenous injection of a small amount of plasma, a component of blood from which all cells have been removed.

However, scientists and a medical expert have explained to WINN FM that umbilical cord plasma has growth factors that stimulate a body’s stem cells to grow, divide and repair.

So while the plasma being used in the JNF project may not contain stem cells, it is being used to stimulate their production.

The Junior Minister acknowledged this when asked at a press conference to explain the difference between regenerative research and stem cell research.

“The other side of the equation under regenerative medicine is that of cord blood plasma type therapies which are platelet infused - and that type of therapy of the like being done at the JNF - is done by [an] IV treatment, and what the scientist is in fact trying to do is to encourage the human body into creating its own stem cell for regenerative purposes, for example, the repair of damaged tissue and organs.”

The project came to the public’s attention just over a week ago, when the retiring CMO charged that his abrupt retirement was triggered by his objection to the way the project had been set up.

The government has rubbished his claims, charging that Dr. Martin – how three years past retirement age - was well aware that his retirement was pending. 

The government meanwhile – despite Dr. Martin’s claims otherwise, has insisted that there was no breach of the Public Health Act in the establishment of the project in a section of the private ward at the JNF Hospital. 

The Junior Minister of Health says advice was sought on the project and a second generative medicine project that it has been approved, from a number of other sources, including members of the Medical Board and PAHO. 

St. Kitts Biomedical’s Dr. Redmond too, has indicated that he has sought advice from a panel of experts in helping to assist with the establishment of the project.

But Dr. Martin – who has emphasized that he has no issue with stem cell research in principle - continues to maintain that proper procedure was not followed.

“We have a law, the Public Health Act which empowers the Ministers and CMO, the Chief Medical Officer to do certain things in relation to safeguarding the nation’s health.  One of those things has to do with the monitoring, vetting of research activities.”

In a statement issued to the media on Thursday he quotes sections of the Public Health and Medical Acts, that he interprets identify the office of the CMO as the proper authority to advise on projects such as the one underway at the JNF, including the use and importation of products like blood plasma.

He has also raised the as yet unanswered question of who is in charge of the project.

Dr. Martin in his statement Thursday indicated that he has received a document entitled “Infusion Protocol for Human Umbilical Cord Blood Plasma.”

The document - which WINN FM has also received a copy of - speaks to a JNF Regenerative Medicine/Stem Cell activity.  

Dr. Martin continues to question the involvement of controversial billionaire Peter Nygard in the project.  The government has categorically denied that Mr. Nygard is directly involved but the protocols that speak to Human Umbilical Cord Blood Plasma have the word “Nygard” printed on the cover page. 

WINN FM understands that Mr. Nygard has reportedly been seen on the JNF premises.

The Medical Chief of Staff at the JNF Dr. Cameron Wilkinson, who is now also the Acting Chief Medical Officer, has made reference to a stem cell project that received generous support when it was proposed over a year ago, but he said that it did not come to fruition.

It is not clear if the Nygard protocols that have now surfaced are those of that abandoned project, but what is clear is that they are also those of a Human Umbilical Cord Blood Plasma infusion project.

The Nygard document lists the Responsible Party as the Frigate-Bay based, Advanced Institute of Regenerative Medicine, and the Principal Doctor is identified as S. Lagrotta MD, the same Dr. Lagrotta who is working on the identically named research underway at the JNF.

The government has acknowledged that Dr. Lagrotta is not registered and not licensed to practice in the Federation.  It insists that she has observer status only and that the process of her certification and licensing has been initiated.

“A Brazilian expert, Dr. Silvia Lagrotta, who is attached to the project does not and has not ever administered any therapies to any patients in St. Kitts and Nevis.  Her presence thus far has been strictly limited to observing the process as a representative of the investor group’s Brazilian partner.  In anticipation that Dry Lagrotta will be professionally engaged during the life of this project, her medical credentials have been submitted in the normal course for approval to function within the Federation as a medical practitioner consistent with the laws and regulations of the Federation,” Senator Phipps said in a public statement.

The Senator has advised that the therapies are being administered by two staff nurses at the Hospital, with pro bono volunteer oversight by Dr. Dwain Archibald (a staff doctor) and further oversight by the JNF’s Medical Chief of Staff - now also appointed Acting CMO - Dr. Wilkinson, along with the Director of Institutional-based Nursing Services Matron Sonia Daley-Findlay.  

Retiring CMO Dr. Martin however, says that when he approached Dr. Lagrotta at the JNF on June 13th she appeared to be ‘on the job.’

“There was a Brazilian doctor there who was practicing without registration or license.  How do I know that?  She was identified to me by Dr. Archibald and she had a stethoscope around her neck - that is Dr. Archibald who was identified in the Minister’s…speech.  The Brazilian doctor had a stethoscope around her neck and she had gloves on.  I shook her hand, after she took off the gloves of course, and told her that she was practicing in violation of the Medical Act and that she should cease, desist and leave the premises,” Dr. Martin told WINN.

There has been no clarification of that claim on the part of the government and no clear statement on who is in charge of the JNF research therapy.

Meantime, St. Kitts Biomedical’s Dr. Redmond, who does work in stem cell research, has ruled himself out as overseeing the JNF initiative.

In his statement this week, he made it clear that neither he nor his Foundation is participants in the project.  He says they have provided advice to ensure that any experimental treatments are done according to the most rigorous international standards.

His statement did seem to contradict that of the Dr. Wilkinson who said this week that Redmond ‘spearheads’ the project.

Contacted for clarification on Friday Dr. Redmond told WINN FM he could appreciate that Dr. Wilkinson used the term spearheading to describe his role, but he insisted that it was purely advisory.  He reiterated that he was not a participant and was seeking only to ensure that the group had covered all the bases in establishing the project.

He said he was determined that he was not going to be directly involved in the project, but was concerned because there are a lot of disreputable medical tourism projects going on in the Caribbean and other places around the world. 

He told WINN that that he wanted to do what he would could with his connections in the scientific community to try to help St. Kitts do something that was safe and reputable. 

Dr. Redmond emphasized that he supports the recommendation from a panel of scientific experts that he assembled in St. Kitts last year, that legislation should be passed to establish a “Medical ethics and scientific review board.” Such a body he said would consist of local and international experts to evaluate and recommend the approval or rejection of any new therapies that are proposed for the Federation by any party in the future.

In summary, a week later it has been established that the project involves the stimulation of stem cells to encourage their regeneration, and that legislation has yet to be passed to govern such research. 

It is not clear however, whether Peter Nygard - an advocate of stem cell technology to reverse the afflictions of aging and the founder of the Bahamas-based Nygard Biotech – is in some way involved or associated with the current project at JNF.  It is also not clear who is in charge of the project as Dr. Lagrotta awaits appropriate licensing and is according to the government, an observer.

Other as yet unanswered questions raised this past week by the retiring CMO Dr. Martin include how the blood plasma is being brought into the country, why relevant US FDA registry has returned no results for the phrase “Human Umbilical Cord Blood Plasma Phase 1” undertaken by the party named in the protocol document and whether a US FDA approval is license to conduct research in the sovereign state of St. Kitts and Nevis.

WINN FM continues to follow this developing story.

Photo (left to right): Medical Chief of Staff at the JNF Hospital and Acting CMO Dr. Cameron Wilkinson, President St. Kitts Biomedical Research Foundation Dr. Eugene Redmond, Retiring CMO and President of the St. Kitts and Nevis Medical Board Dr. Patrick Martin, Junior Minister of Health Senator Wendy Phipps

Toni Frederick

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