Bengaluru, April 25
Cord blood banking (CBB)
with dubious benefits has become a money-making scam in India and needs
tighter control to protect gullible parents from being exploited, top
medical researchers say.
Blood collected from umbilical chord
after child birth is a rich source of stem cells similar to those in
bone marrow. These cells could some day be used as treatment if the
child ever falls ill with certain diseases.
The business of
harvesting and storage of cord blood for future use has surged in the
past decade into big business with 15 private banks offering this
service. They target expectant mothers by touting cord blood as a form
of "insurance" in case their children ever get sick.
The storage
does not come cheaply. It costs between Rs.50,000 and Rs.100,000, and
some banks charge an annual fee. With India reporting 25 million or more
child births a year, CBB is viewed by the industry as a cash cow.
LifeCell,
which set up shop in Chennai in 2004, claims it had over 100,000
subscribers and Cryo Stemcell in Bengaluru says it has 30,000. Others
are not behind.
However, unethical marketing tactics and inflated
promises by these largely unregulated banks have alarmed top stem cell
researchers and professional bodies of gynaecologists.
"It is
time to restrict the rampant commercialization of CBB," Jyothsna Rao,
Secretary of the Bengaluru-based Society of Regenerative Medicine and
Tissue Engineering, told IANS.
"The government needs to establish
a high powered committee to look at this menace at the earliest," says
Satish Totey, a leading stem cell researcher and CEO of Kasiak Research
in Mumbai.
The original idea for CBB was for overcoming the
difficulty of finding a right bone marrow donor for regeneration of
blood cells, Rao said. "But this very useful adjunct to bone marrow
transplantation has been reduced by some companies to the status of a
cosmetic product."
LifeCell, for instance, uses a prominent film
star for endorsement and one bank in Bengaluru offers "attractive
prizes" to mothers who bank with them.
"Several nasty marketing
methods including bribing the doctors and nursing staff are used for
recruiting donors," says Rao. Hospitals too are part of the scam, adds
Totey.
Last year, the Competition Commission of India fined a
Mumbai hospital that was getting Rs.20,000 from a cord blood bank as
commission for every patient referred to it.
While in the US and
Britain operators cannot advertise cord blood as a "life insurance",
Totey said families in India were fooled by claims that it was a cure
for all.
"Stem cell therapy for other than blood-related
diseases and metabolic disorders are in the early phase of trials and
remain only speculative," he said.
"I have been very vocal
against private banks making claims that are all futuristic except few
of the conditions," says Jayesh Sheth of the Foundation for Research in
Genetics and Endocrinology in Ahmedabad.
In fact, the US Food and
Drug Administration has approved the use of cord blood "only" for
treatment of blood-related illnesses. It asks patients to "be skeptical
if cord blood is being promoted for uses other than blood stem cell
regeneration".
There are other hard facts these banks do not reveal to their subscribers.
For
instance, the cord blood of a newborn may not contain stem cells in
sufficient numbers to be useful in adulthood, says Deepa Bhartiya, head
of stem cell biology at the National Institute of Research in
Reproduction in Mumbai.
Also, one's own stem cells are not
useful to treat genetic disorders as they will have the same genetic
flaws that caused the disease in the first place.
"And no one really knows for how many years the banked cord blood will be usable," adds Totey.
"Our
operators in India do not check the viability before releasing the stem
cells for transplant and nobody bothers to discard contaminated
samples."
LifeCell spokesperson Krithika Narayanan, however, denies this.
"Prior
to release, the samples are tested for potency and viability through
tests prescribed by the American Association of Blood Bank standards,"
she told IANS.
According to Totey, there were very few documented
cases of a child receiving his or her own banked cord blood as
treatment although the sibling or a close relative may benefit from it.
Hence,
private banking of cord blood may be considered "only if there is a
high-risk family medical history of disease(s) currently treatable by
cord blood".
LifeCell admits that in ten years it released just
34 cord bloold units of which only five wer for autologus transplants
for treating cerebral palsy. The rest were for transplants in patients
who were not the donors.
In its 11 years of existence Bengaluru's Cryo Stemcell released stem cells for 10 transplants, mostly in donors's relatives.
"In
fact cord blood stem cell transplant numbers in India are miniscule and
they are mostly for cancer and thalassemia," says Totey.
For all
these reasons, Italy and France have banned private banking of cord
blood. Both the American Academy of Paediatrics and the Society of
Obstetricians and Gynaecologists of Canada discourage this practice
while encouraging the storing in public banks that store cord blood free
of cost and charge only when released for treatment.
"With
public banks -- where large number cord blood units from HLA (human
leukocyte antigen) matched donors are possible to store -- the benefits
could reach a large patient population (besides the donor)," Rao said.
"Stored
cord blood units to treat blood disorders can be done only with
allogeneic (not one's own) units, which could be sourced from a public
cord blood bank.
"A panel of eminent gynaecologists discussed the
issue of cord blood banking at our Society's meeting in February and
unanimously concluded that public banking is the only answer," Rao said.
"We are against the concept of private banking." But who should promote
public banks?
The Drug Controller General of India said that,
being only a regulatory body, it was concerned only with licensing and
not promoting them.
According to Totey, the issue was discussed
earlier by the Department of Biotechnology and the Indian Council of
Medical Research "but they were reluctant" to promote a public bank.
(K.S. Jayaraman can be contacted at [email protected])
