'Worldwide hype may leave people open to exploitation'
As an executive committee member of the Harvard Stem Cell Institute, George Daley is as hopeful as anyone that stem cell research can lead to major breakthroughs in the fight against disease.
But Dr. Daley fears worldwide hype surrounding the field is leaving many patients with life-threatening illnesses potentially open to exploitation.
Suffering life-threatening or terminal illnesses, many patients are willing to pay tens of thousands of dollars for stem cell treatment — even if there's no widely accepted medical proof that the procedure they will undergo will result in vast improvements to their quality of life.
As president of the International Society for Stem Cell Research, Dr. Daley is determined that patients do not fall victim to what he describes as the "quackery" of medics who put them at risk.
Until he was contacted by , Dr. Daley had neither heard of Stemedica, nor the plans for an adult stem cell clinic in Bermuda.
Stemedica and its partners Premier Ewart Brown and wife Wanda have not outlined exactly what research or treatment will take place in the centre, although they have previously declared their intentions to treat "a wide array of medical conditions" including stroke, Alzheimer's, Parkinson's and diabetes.
Dr. Daley is associate professor of Pediatrics and Biological Chemistry at Boston Children's Hospital and Harvard Medical School and associate director of the Stem Cell Program at Children's Hospital. His research has mainly focused on embryonic stem cell research.
He believes research should only be done when it can be properly regulated under rigorous oversight — and not yet in a country like Bermuda where it is understood no such regulations are currently in place.
He told: "Right now the only adult stem cell therapies that are widely accepted by the medical community involve blood and bone marrow transplantation. Anything else is highly experimental."
He expressed scepticism of any group wanting to provide stem cell treatments in jurisdictions like Bermuda which appear to have no stem cell regulations.
"I'm very concerned about the rapid attempt to translate stem cell into therapies long before there's real medical justification," he said.
"It's a big enough risk given there's so much hype, promise, of stem cells. It's very easy for people to be misled into thinking the cures are already here when they aren't. I have tremendous worry that patients are being taken advantage of.
"No one should be misled into thinking there's some kind of medical cure. There isn't. We are just beginning."
He said that, in a worldwide context, he was worried people could take advantage of publicity over stem cells for their own financial gain, preying on those who feel desperate about their conditions.
He said such people could put patients at risk of greater personal harm, and were offering "quackery" as opposed to medical treatment.
sked if he had a message for patients thinking about taking stem cell treatment, he replied: "Be very sceptical of promises that are not substantiated.
"If the story is too good to be true, it probably is not true. If the claims are miraculous, you have to be very suspicious. There are no easy fixes.
"Medicine doesn't advance by anecdotes: 'I did this to this person and look how they turned out' — that allows us to establish a hypothesis. There are very few widely accepted medical therapies that involve stem cells."
In the UK, the US and Canada, stem cell research is heavily regulated by groups such as the Human Fertilisation and Embryology Authority in the UK.
San Diego-based Stemedica operates in a number of other countries including Russia, Mexico, Italy, Switzerland and France, while a centre in Korea is also proposed.
But Dr. Daley warned of the importance of regulations and said the ISSCR was pushing for global guidelines for researchers and patients.
He said even with no overseeing group in Bermuda, the Island could still follow international codes such as the Declaration of Helsinki, a set of ethical principles for the worldwide medical community regarding human experimentation.
The Declaration of Helsinki states, among other guidelines, that research should be based on a thorough knowledge of scientific background, taking a careful assessment of risks and benefits.
"Even when you are dealing with drug companies that have the best of intentions for new cures for disease, it's always possible you will do more harm than good," said Dr. Daley. "One of the general principles of medicine is that you don't harm anyone. To give your patient the best possible treatment medically doesn't advance through random, unscientific kinds of strategy. There's accepted international standards of clinical trials. They are subjected to very rigorous oversight, and they should be.
"Given this concern, the ISSCR is canvassing a task force to study this issue, to provide guidance to patients as well as practitioners for what really needs to be in place in order to make this move safely forward. Otherwise we put patients at undue risk. You risk sullying the reputation of the field.
"I feel fortunate to live in a country (the US) where there is attention paid to protecting human subjects and research. I don't know where Bermuda is in terms of laws, but there are international doctrines medically agreed on. The Declaration of Helsinki for example.
"The reason why these guidelines are put in place by society is because there are always people looking to exploit the vulnerable."
Calling for Stemedica to explain what treatment it will be carrying out, he added: "What is the nature of the cells they are planning to use? What are they charging for this therapy? If you hold it up to scrutiny, is it something acceptable to community standards?"
