By K.S. Jayaraman,IANS,
Bangalore : An international effort is on to protect desperate patients from becoming victims of costly and unproven stem cell “therapies” being marketed in several countries, including India and China.
Alarmed by a rise in “stem-cell tourism” driven by websites and the internet, a task force of the International Society for Stem Cell Research (ISSCR) with its headquarters in Deerfield, Illinois (US), has issued a set of guidelines.
While researchers worldwide are investigating stem-cell therapies for many diseases, the only proven therapies right now are transplants of bone marrow stem cells to reconstitute the blood, treat blood disorders such as leukaemia and immune deficiencies.
“All other medical procedures involving stem cells are only experimental” and should not be promoted as cures, the ISSCR says.
But a team led by Timothy Caulfield at the University of Alberta’s Health Law Institute in Canada surveyed 32 websites offering treatments for conditions ranging from Parkinson’s disease, stroke and paralysis, spinal cord injuries and cancer to anti-ageing treatments.
The survey found that only one site described its procedure as experimental and 26 sites advertised it as being “routine”.
The websites, many of which advertise clinics in China, India, Mexico and the Ukraine, actually rely on patient testimonials, rather than peer-reviewed clinical studies, as proof that their therapies are safe and effective, the survey found.
For instance, the website of an institute in Chennai advertises stem-cell treatment for diabetic ulcer, ischemic heart disease, spinal cord injury and cirrhosis of liver alongside glorious tributes from patients and flattering newspaper reports.
The draft guidelines, to be finalised next month, “aim to define the scientific, clinical, regulatory, ethical and societal issues that must be addressed” before using stem cells in clinical practice, says Olle Lindvall, neurologist at the University of Lund in Sweden and chairman of the task force.
The ISSCR says it is deeply concerned about (a) the potential physical, psychological, and financial harm to patients who pursue unproven stem cell-based “therapies” and (b) the general lack of scientific transparency and professional accountability of many of the clinics involved.
The seriousness with which the problem of stem-cell tourism is viewed by the ISSCR can be gauged by the strong language used by its 30-member 13-nation task force that drafted the guidelines.
It says: “The ISSCR condemns the administration of stem cells or their direct derivatives to patients outside of a clinical trial, particularly when patients are charged for advertised medical services that constitute clinically un-established interventions that have not been approved through independent review.”
The ISSCR has asked scientists, clinicians and healthcare institutions not to participate in such activities as a matter of professional ethics.
“Regulators in countries where such illegitimate therapies are offered have a responsibility to prevent exploitation of vulnerable patients by investigating the claims made by clinics and, if necessary, forcing fraudulent clinics to close,” the task force said.
Exploitation of vulnerable patients in the name of innovation or with false claims “is a very serious matter”, admits Alok Srivastava, head of the Centre for Stem Cell Research at Christian Medical College, Vellore, in southern India and one of the members of the ISSCR task force.
“There certainly are clinics in India and many other countries that are exploiting patients with false promises of successful medical treatment for conditions where currently we do not have effective therapies,” Srivastava told IANS.
He said a serious problem is the web-based advertisement of many of these clinics “with blatantly false claims (or those bordering on these) to promote their work”.
However, he noted that this “exploitation” is not limited to patients from outside of those countries but also applicable to the local people.
“It therefore becomes the responsibility of the scientific, medical and regulatory bodies in these places to prevent such clinics from cheating the local people as well as the world citizen.”
The ISSCR guidelines provide criteria for the characterisation and production of stem cells used for human transplantation as well as the level of evidence that should be required through lab and animal studies before conducting human clinical trials.
The mere fact that a procedure is medically innovative does not automatically make it suitable for testing in humans.
“Assessment of efficacy in pre-clinical animal models through independent peer review is a central element of the approval process for advancing to human clinical studies.”
Srivastava however points out that the aim of ISSCR guidelines is “not to restrict medical innovation but to provide a logical and scientific path for it”.
According to the guidelines, clinicians may provide unproven stem-cell interventions to a very small number of patients without a formal clinical trial “in exceptional circumstances” provided (1) the written plan is approved by experts who have no vested interest in the proposed procedure and (2) the institution is held accountable if anything goes wrong.
While the guidelines are not legally binding, the ISSCR hopes they will serve as framework for laws that protect patients from being swindled or harmed.
The guidelines require researchers to present their results at a professional scientific conference or in a peer-reviewed scientific journal before reporting their research to the lay media.