Spinal Cord editorial on ethical for charge trials/use of cellular regenerative therapy - implications for HBO and IHMA?

[Guest guest]

There's an editorial in the most recent issue of Nature Spinal Cord regarding

the ethics of " unproven " SCI cellular therapies, saying that the ISCoS has come

to a new set of guidelines that the editors paraphrase as, " At this time, it is

unethical to sell such unproven therapies and we do not advise patients to spend

their money by paying for such treatments. " This obviously has implications for

HBO therapy, even at-cost therapy as is done in your practice ( " Who says what's

at-cost? " ) While the intent here is good, it seems a bit much like a back-door

way of controlling what people *know* about (not like they don't already have

that kind of control..) It also puts even more power in the hands of people who

have a lot of money invested in the field.

(re-published under assumption of fair use for educational purposes)

Spinal Cord (2011) 49, 485; doi:10.1038/sc.2011.25

" New techniques? Yes, but let it be ethical. A warning from ISCoS "

J J Wyndael, Ed.

“Dear Spinal Cord reader,

On behalf of the International Spinal Cord Society (ISCoS), the Editorial page

of this issue is devoted to a warning to spinal cord injury (SCI) individuals.

‘People living with SCI are interested in any treatment that will increase their

functional capabilities and improve their quality of life. Much of the

excitement for therapeutic cell transplants comes from the reported benefits of

cell transplants for other disorders. It is true that certain bone

marrow-derived (hematopoietic) stem cells have been successfully used to treat

some blood-borne and immunological disorders, but to date, this has not been the

case for embryonic stem cells or other ‘adult’ stem cells in the treatment of

SCI. Nevertheless, cell transplants into the injured spinal cord are being

offered by several clinics around the world.

As with any serious medical condition, people are susceptible to claims

promising recovery, even when the costs are high and potential risks are

unknown. It is morally unacceptable to prey on desperate people and profit from

their hope for a cure, but it happens. Please remember, if it sounds too good to

be true, it is too good to be true! Individuals or institutions selling cellular

transplants have not carried out controlled trials with valid methods and

outcomes recorded by objective (blinded) observers. Because of a clear conflict

of interest or bias, it is not acceptable that those who profit from providing a

treatment should also carry out the evaluation of the treatment.

Providers of these cell transplant procedures attempt to establish credibility

by citing experimental studies that have no direct relation to SCI (see above,

blood-borne disorders). They also rely on reports from patients or family

members. Patient-reports are tainted by what is known as the placebo effect

where the patient's belief in a treatment results in their description of an

improvement when nothing has actually changed. This is especially true after SCI

where sensation, muscle spasms or residual reflexive movements can vary daily.

The only accurate way to determine that a treatment is beneficial is to carry

out a properly designed study with an appropriate control group. ISCoS believes

it is unethical to charge patients for experimental interventions that are not

yet proven safe or effective. Some properly conducted trials are now being

undertaken, but we must await the results from these objective studies. It is

also important to remember that valid clinical trials do not ask patients to pay

money to participate in a trial or receive an experimental treatment.

Most cell-based treatments carry significant safety risks, many of which are

common to surgery and transplantation in general, including the possibility that

the cell transplant could stimulate the formation of cancerous tumors. Although

high-risk therapies may be justified in people with terminal illnesses, the risk

of using these therapies after SCI is not advised when individuals with SCI can

achieve as good or better recovery with conventional medical care and

rehabilitation training.

ISCoS does not rule out the possibility that cellular transplants may improve

function and quality of life for recipients and justify the risks, but insist

that the proof of benefit from cell transplants must come from a valid

clinical-trial program. At this time, it is unethical to sell such unproven

therapies and we do not advise patients to spend their money by paying for such

treatments.

More information on questions that should be asked of someone offering a

treatment of SCI is available in the free document ‘Experimental Treatments for

Spinal Cord Injury: What you should know’, available in several languages at the

International Campaign for Cures of Spinal Cord Injury Paralysis

(www.campaignforcure.org).’

In this issue you will find several high level papers, a nice review on neural

plasticity and functional recovery, and many original research reports.”