KEY POINTS:
Andrew Commons is determined to walk again - utterly determined. As well as following an intensive daily exercise regime, he's also undergone courses of stem cell treatment for the spinal cord injury that has confined him to a wheelchair.
Just back from Beijing Tiantan Puhua Hospital, Commons says it's too early to tell whether several injections of stem cells into his spine have worked, but he's optimistic.
"I've now got a bit of movement in my left big toe, which is pretty good. They say if you can move your toes, you'll walk at some stage, so obviously I'm pretty hopeful about that - if the stem cells do have a benefit, with luck I'll be on my legs."
He attributes the movement in his toe to an earlier course of stem cells - taken from his own bone marrow - that he received a year ago in Chennai, India.
Commons, who was injured in a fall through a roof, belongs to an increasing number of people with spinal cord injuries, including the late Christopher Reeve of Superman fame, who are prepared to do whatever they can to regain lost function. A lawyer with Hornabrook Macdonald, Commons says he's fortunate in being able to fund his own treatment. Which is why he's dismayed by the Multi-Regional Ethics Committee decision to decline a research trial here that could have offered hope to others. The role of ethics committees, established under the New Zealand Public Health and Disability Act, is to provide independent ethical review of health and disability research to safeguard consumers.
Commons says the trial, involving transplanting nasal tissue (rich in olfactory ensheathing and stem-like progenitor cells for neural repair) into patients with injured spinal cords, would have provided a first step in developing stem cell-based treatments here.
He's concerned that the committee has turned down the Dunedin-based trial without adequately considering the point of view of the people needing help with "the trauma or the torture of their everyday life".
As he points out, those with a complete spinal cord injury don't have bowel or bladder control, can't stand and are often in a lot of pain, so any procedure, even if it's a small gain, towards improving that quality of life is a huge help. Commons sees the refusal to allow the research as a patronising decision going against the right to choose health treatments.
"You're disempowered once when you have the accident. You're disempowered twice by having the ability to improve your lot refused you."
Karen Jones, quadriplegic for 10 years, agrees. "People should have the right to choose any treatment that might benefit their current condition if they know the pros and cons. They should be able to make an informed consent for themselves."
Had she been given the chance, she would have volunteered for the New Zealand trial. "It would give me the possibility of getting my hands back, which means more function and more independence, which means more freedom. Any return in function would improve my day-to-day life."
Jones says such possibilities far outweigh the risks of the operation. "Every day you battle with the risks involved with a spinal cord injury - pressure sores, getting infections and other conditions which develop over time." She sees the ethics committee decision as overly cautious.
"We used to be a pioneering country - how do you know what's possible if you don't do the research?"
The research in question was proposed by the Spinal Cord Society of New Zealand, which has a laboratory at the University of Otago's Centre for Innovation headed by Dr Jim Faed. Over the last year, with ethics committee approval, the laboratory has been working on ways to grow cultures of bone marrow-derived mesenchymal stem cells.
Complementing, its laboratory work, the society sought ethics approval for a trial of olfactory mucosal auto-transplantation - essentially a graft of the patient's own nasal tissue into the site of their spinal injury. The pilot study, which would have been funded by charitable donations, sought to replicate the work of Dr Carlos Lima in Portugal who has operated on about 60 patients since 2001.
Early reports of his work indicate a relatively safe procedure with mixed results. All patients have showed some improvement in function and some have had significant gains. One - Susan Fajt, who gave her testimony to a United States Senate committee in 2004 - can now walk with braces.
But the New Zealand ethics committee took a dim view of the proposal and turned it down, saying the methodology was rudimentary, that there was no long-term safety data for the procedure and no scientifically accepted evidence that the treatment offered any benefit.
The response mystified Faed and the clinical team he had assembled for the study. Since when was a procedure being seen as rudimentary an ethical reason to turn it down? True, there was no long-term data, but this was an early-phase study, so to be required to produce long-term outcomes before doing the research was a conflict in terms. And to say there was no evidence of benefit was incorrect, as some of Lima's cases showing modest improvements had been published in the peer-reviewed Journal of Spinal Cord Medicine.
But what was more annoying, was that the committee seemed to have missed the whole point of the study: To test how well it worked and to find out what part the intensive rehabilitation that accompanied the procedure played in the results.
"We included a control group of subjects in our planned trial to shed some clinical light on the important issue of whether or not rehabilitation therapy accounts for some of the benefits described by Carlos Lima. By adding a control group, we were trying to address the issue of efficacy," says Faed.
The Spinal Cord Society was further disappointed by a second opinion provide by the Health Research Council Ethics' Committee, which found the Multi-Region Ethics Committee had followed an appropriate process and agreed the research should not be approved. Its report said that although the desire to progress to experimental treatment was understandable, the state of the science must support the transition.
"When the transition progresses to clinical trials, especially those involving invasive procedures, they must be rigorously designed to produce clearly interpreted outcomes otherwise a procedure with no proven benefits could become widely used, thereby exposing the participants to risk with the expectation of benefit when it is actually uncertain if any benefits will result."
The society then appealed directly to Health Minister David Cunliffe who, while he cannot challenge the committee's decision, can look at procedure.
The society's concerns got a boost from the MP for Dunedin North, Pete Hodgson, also the Minister of Research Science and Technology. Hodgson pointed out that the terms of reference for ethics committees stated that they must "collaborate with researchers to ensure the interests, rights, dignity, welfare, health, and wellbeing of participants and consumers are protected" and also "give due consideration to community views".
Hodgson argued that "collaborate with researchers" implied "a somewhat more interactive open process" than the application received.
And that it wasn't clear whether the committee had adequately weighed the strong support of consumers in its decision.
SO DID the ethics committee consult with spinal cord-injured people? "It was not within the domain of the ethics committee to do that," says committee member Cynthia Darlington. She acknowledges that the committee excluded information provided by the Spinal Cord Society about people who died because of spinal injury - describing it as "all kinds of emotion-fraught, non-meaningful information".
She agrees the society should have been told that the information was excluded and why.
Darlington, who has a son paralysed from the mid-chest down, says she is not against stem cell-based research.
"I think stem cell work is terrific and I would love to see something that would help people with spinal cord injuries."
Does she have views on giving people with spinal injuries false hope? "They are very vulnerable and they hope beyond hope that somehow they are going to regain function - prayer, magic, a strange spa in Mexico - they always hope."
But off-beat procedures, says Darlington, are very different from a medical procedure that's received approval. With those, she says, spinal cord-injured people have to think they have got a good chance. "From that perspective they are considered a vulnerable population."
She says the reasons the research was turned down was because of insufficient documentation to show the procedure was safe, and the opinion from independent referees. "All the independent referees felt it was premature to begin a clinical trial."
Faed says the ethics process has repeatedly gone off the rails, that both committees have not engaged with the society in a meaningful way and have accepted arguments against the research based on scientific politics rather than ethics.
"The committee was operating at arm's length from us in a rather secretive manner and it became a very one-sided power structure. Too many are saying that there is still a lot more to learn and we shouldn't do any human trials at this stage. I think that is the wrong approach - it is focusing on what is not known, rather than on what is known. It is paternalistic and unethical."
Chief executive of the Health Research Council, Dr Robin Olds, disagrees. He says the process was transparent and all the parties involved knew what the process was.
"I agree we didn't meet face-to-face, but there was certainly ample opportunity via correspondence to respond to things."
THE impasse awaits a final word from Cunliffe, who seems likely to back the findings from both ethics committees. But there is a glimmer of hope.
"I have confidence in the ethics committees," Cunliffe told the Weekend Herald.
"However, I have sought further information on the process as I promised to representatives of the Spinal Cord Society."
Faed says what the committees need to take on board is the ethical position that no one has the right to impede patients who want to access this treatment in New Zealand as long as they understand the nature of what they are trying to access.
"Essentially the message we've received from some is that a group such as ours, under the present ethics environment in New Zealand, can't be permitted to do clinical trials. I think that is unreasonable."
Commons agrees: "It is fundamentally a human rights issue - it is not up to a third party to dictate to me what I should be able to do to better my lot.
"The ethics committee role should be confined to insuring that the procedures that are done are not likely to cause greater harm than good."
