(From the Irish Medical Times)
May 12, 2009
Erica Mills reports from a recent conference that explored the divide between fact and fiction in the public’s perception of stem cell research and therapies.
Stem cell research is undoubtedly one of the most contentious and widely discussed subjects in medicine today. Bursting into the public perception in 1998 with the creation of the first stem cell line and further brought to public awareness by celebrities such as Michael J. Fox and the late Christopher Reeve, stem cell research has been sold in equal measures as a miracle treatment and as the unforgivable and inexcusable destruction of unborn human life.
Supporters of stem cell research and therapies argue that it has the potential to award sufferers of debilitating diseases and conditions a better quality of life; detractors are concerned with the moral implications of embryonic stem cell usage. With the cacophony of competing voices, how can the average person be expected to make sense of it all? How much of what they hear is fact and how much of it is half-truths or complete fiction?
This subject can be an overwhelming and confusing one. The need for clarification and honesty is what prompted Stephen McMahon of the Irish Patients’ Association (IPA) and Dr Stephen Sullivan of Trinity College to organise a conference to address some of the issues surrounding stem cell research. This conference attempted to debunk some of the common myths about the current trends in research and therapy and expose the ways in which patients could be potentially scammed.
This subject can be an overwhelming and confusing one. The need for clarification and honesty is what prompted Stephen McMahon of the Irish Patients’ Association (IPA) and Dr Stephen Sullivan of Trinity College to organise a conference to address some of the issues surrounding stem cell research. This conference attempted to debunk some of the common myths about the current trends in research and therapy and expose the ways in which patients could be potentially scammed.
A wide range of experts
Chaired by Brock Reeve, Executive Director of the Harvard Stem Cell Institute and half-brother of Christopher Reeve, this conference included a wide range of experts on the subject including Dr Hiram Chipperfield, Regulatory Affairs Project Manager for ERA Consulting (UK) Ltd., Dr Orla Hardiman, consultant neurologist for Beaumont Hospital and Dr Fionnuala Gough from the University of Manchester. Also speaking was Dr Patrick Costello of the Irish Medicines Board.
Taking place in the Science Gallery of Trinity College Dublin on April 22, 2009, the conference saw the attendance of a large number of patients’ groups, particularly those with spinal injuries — and one person even travelled from France to hear the information on offer.
The conference’s timing coincided with another big story on stem cell therapy, the case of an Irish couple who are travelling to China to pursue stem cell therapy for their eight-month-old child. Maria Kieran and Tommy Cullen are hoping that stem cell therapy might help to restore the sight of their daughter, Gretta Kieran Cullen, who suffers from septo optic dysplasia.
Concerns were raised, however, when it emerged that this treatment was costing the family €60,000. So should a treatment cost that amount? Absolutely not, said Dr Sullivan and Dr Hardiman when asked by Stephen McMahon about the potential risk of patients and their family being scammed. “Clinical trials should not cost you money,” asserted Dr Hardiman.
Stem cell treatments in humans are still in the experimental phases according to Brock Reeve. None are further than Phase II, according to all the experts at the conference. Geron Corporation, one of the biotechnology companies at the forefront of research, is only at Phase II of clinical trials.
There is a danger that stem cell therapy is being sold as ‘snake oil’ and that the realities do not match the expectation. A quick search of the internet throws back the promise that stem cell therapy has ‘cured’ from 70 to 73 conditions. “Not so,” said Reeve when questioned about this by Stephen McMahon. According to Reeve, this number was arrived at by those who have an agenda to further.
A little research confirms that this is true. The common search result which states that adult stem cells have cured seventy-something conditions while embryonic stem cells have cured none is deliberately misleading. Many of the adult stem cell treatments listed are in fact autologous stem cell transplants — the practice of removing stem cells before treatments such as chemotherapy and then giving them back to the individual after treatment to promote cell growth. This practice has, of course, been used for many years and refers to haematopoietic cells rather than the induced pluripotent cells (iPS) which are currently being studied.
The research of iPS is still in its infancy and the effects of iPS are not fully known. This much-peddled promise of a cure is misleading. Adult stem cells have indeed helped in the treatment of patients for many years; however, there is no way they can be said to have ‘cured’ patients. Rather, they have aided their treatment by replenishing the body’s blood which may have been depleted by an aggressive therapy such as chemotherapy.
Advances made in mice
The cells referred to are not cells which have been manipulated to pluripotency but are actually the same cells of which the body has been depleted — reinserted to promote growth. To point to this common treatment as a cure is to give hopeful patients false hope; in reality, we are far from administering iPS cells, tissue specific cells or embryonic stem cells as treatment. Currently, great advances have been made in mice. Is it unrealistic to expect that humans might soon be treated?
According to Stephen Sullivan, it is hard to speculate. “Sometimes in research mice can be good approximations. Ultimately, you need to go into bigger vertebrates like pigs. Just because it works in mice or pigs does not mean there is a correlation to humans,” he said.
Currently, patients are eager to put themselves forward for patient trials and Stephen McMahon proposed that the availability of clinical trials should be made public. Besides the issue of commercial confidentiality, Dr Orla Hardiman felt that too great an emphasis was given to clinical trials. So, are patients ill-advised to come forward for clinical trials?
Dr Sullivan and Dr Hardiman both agreed that people expect too much of clinical trials. There is no guarantee that a clinical trial may improve one’s quality of life — it could, in fact, worsen it. There is a danger that patients are disregarding their doctors’ advice in favour of an unproven treatment. “People are pushing for autonomy and doctors are derided for dissuading patients,” said Dr Gough.
Dr Hardiman pointed out that there is no advantage to a person going on a clinical trial. She pointed to trials for motor neurone disease where the patients in the trial were actually worse off than they would have been if they had remained under conventional care as the trials failed.
The stark reality is that 50 per cent of clinical trials fail in Phase III. It is also unclear what effect a stem cell may have on a condition or illness. “In Parkinson’s disease and Alzheimer’s, stem cells already exist but are not turned on,” she explained. “Why would we use more if these existing ones won’t work?”
The lack of legislation is also a potential quagmire. While both Dr Patrick Costello of the Irish Medicines Board and Dr Hiram Chipperfield from ERA outlined the strict protocols all medical testing should follow, the ethical origins of stem cells has not been addressed in this country. Even if an embryonic stem cell follows the strict demands of these protocols, it is neither legal nor illegal to carry out embryonic and stem cell research in Ireland. This leaves the research of stem cells open to ethically unsound practices.
According to Dr Gough, the in vitro embryo has no status under Irish laws. Thus, therapeutic and research applications may not be illegal as it is not covered under legislation (and has never been since IVF treatment was first administered here). Dr Gough further stated that politicians are loath to involve themselves in a bioethical debate on the subject with which the Church has concerned itself.
The experts also debated the advantages of ‘banking’ umbilical cords. While it is comforting to think that one has a ready supply of stem cells, it is unlikely at the moment that any use could be found for them. Stephen Sullivan agrees that while it sounds interesting, it is still experimental and more information is needed before any application can occur. Dr Hardiman is more damning in her assessment. She believes that storing and harvesting umbilical cord cells is a waste of time as they may be useless by the time we know what to do with them. The IPA, however, sees it as an insurance policy and welcomes it as a better alternative to having another child with a view to aiding an ill child.
The subject of stem cell research and therapies is a complex one. It is possible that with the increased funding under Barack Obama’s presidency (George W Bush imposed a ban on funding for embryonic stem cell research), stem cell research and therapy may make the quantum leap into being ready for practical administration.
As it is, however, patients need to be aware that it is not, at the moment, a miracle cure. Those hoping for it to cure injuries such as spinal cord injuries may be disappointed to discover that currently it is plausible only as a treatment for new injuries — it is nowhere near suitable at the moment to treat any injuries where scar tissue has formed.
At present, this is an exciting area of science — not of medicine and patients need to be aware of this fact. It is also not clear at the moment, whether the greatest use of stem cells will come from inserting them into the body or in their use for studying disease. The use of stem cells in studying why cells mutate into diseases is often overlooked. It is possible that the greatest application of stem cell research is in assessing how cells may react to different medications and treatments. What is clear is that stem cell research has the potential to greatly improve the quality of patients’ lives in the future.
Overhyped by the media
According to the experts at the conference, stem cell therapies and research have been overhyped by the media. While it is illegal to advertise unproven treatments, the internet has now made it possible for any group with an ulterior motive to espouse any opinion — opinions that may be biased and unsubstantiated.
Patients should be advised to be wary of any internet site which includes ‘testimonials’ instead of any proof which may be confirmed by their doctor. Any doctor or patient who wishes to research this further can go to http://www.isscr.org, an organisation which advocates the free exchange of information regarding stem cell research, for practical and impartial information.
In closing the conference Stephen McMahon expressed a wish that such discussions should continue, free of bias and unsubstantiated science. “We have started a powerful conversation and we will continue to enable such conversations between all stakeholders and patients with the motto ‘Nothing about us, without us’.”
These conversations and debates should continue to ensure that the public can inform itself completely about this complex subject.
ERICA MILLS 