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An unregulated facility would be 'fundamentally wrong'

A research ethics expert and clinical research scientist in the UK has warned of the potential for complications during treatment procedures which could take place at any stem cell clinic in Bermuda.

Arthur Tucker said flying patients into the Island for treatments which are heavily regulated in other countries but not yet here could be viewed as unregulated and potentially damaging experimentation on humans.

Dr. Tucker, a Bermudian who is chairman of East London and the City Research Ethics Committee, told : "For example, what happens if you get an infection? You inject stem cells into the brain. You can either directly inject into the heart or into blood vessels. You could tear a vessel. What happens if you introduce infection into the spine? What happens it you rip open a blood vessel in the brain?"

He said Bermuda would struggle to cope with emergencies involving stem cell patients as it only has King Edward VII Memorial Hospital.

Dr. Tucker is a principal clinical scientist at St. Bartholomew's Hospital in London — one of the few places in England where stem cell research is allowed, albeit under strict regulations. He is also a senior lecturer at the Department of Clinical Pharmacology at a number of medical institutions, including Bart's and The Royal London School of Medicine and Dentistry.

San Diego-based Stemedica has previously said it teamed up with the Island because of its location near the US and its surroundings which would provide an ideal environment for patients to recover.

Dr. Tucker suggested that the current lack of regulations in Bermuda may be another significant reason.

"This idea you can recuperate in a beautiful place," he said. "Bermuda is very nice, but there are other very nice places. But the authorities in those locations probably would not allow such clinics. Look at some of the countries where Stemedica is active or in planning phases: Russia, Korea and Mexico. Do you want to be part of this?

"For example, as a patient in the United States, if you are absolutely desperate, you go to Russia or Korea. Choosing between Russia, Korea and Mexico, you would probably think about going to Mexico. Then all of a sudden Bermuda pops up. Bermuda's a British territory, it's cleaner, it's about impressions."

He said any operation in Bermuda had the potential to be financially rewarding bearing in mind patients have paid tens of thousands of dollars for treatment elsewhere when told it could improve their quality of life.

"If you are absolutely desperate and have got Parkinson's, a terrible life-threatening and debilitating illness, how much would you pay if someone convinces you they are going to effectively and safely treat it?" he asked.

Stemedica has previously stated its centres around the world would take part in "case study research".

Dr. Tucker said: "It's entirely experimentation. There's no good evidence in the world that this is established therapy."

He added that, while he had no problem with Dr. Brown personally or professionally, he believes introducing a stem cell facility into Bermuda without regulatory oversight would be "fundamentally wrong". He called for Bermuda to set up an ethical committee of between ten and 20 Bermudians including medics, religious representatives and lay people.

"I feel very strongly about this," he said. "There are rights and wrongs in everything, but this is obvious. This is the high end of medicine. It's cutting edge.

"Europe and the US are the leaders in the field. How come they are not acknowledging the technology? We are still children in the field of application of stem cell technologies. We don't understand it. With enormous power and potential, there is also enormous risks."

So far, the Browns and Stemedica have not revealed details of what kind of research will take place in Winterhaven, although they have revealed it will initially be staffed by at least three Bermuda HealthCare Services physicians and two Stemedica physicians while one or two stem cell patients a week will be treated.

Asked whether it was feasible meaningful research could be carried out in such a small facility, Dr. Tucker said: "I would be very surprised if the very limited staffing or the modest facilities proposed will be able to produce high impact, meaningful research."