Monday, June 16, 2008

Better feel: Shannon, with her daughter, having partly recovered from paraplegia after treatment by Delhi's Dr Geeta Shroff
CONTROVERSY: STEM CELL THERAPY
Life Is A Laboratory
A Delhi doc's 'stem cell' therapy 'cures' patients. "Foul," cries the West. ...
Shruti Ravindran



Two years ago, 33-year-old Shannon Centman, an American Navy officer stationed in Port Huenme, California, fell asleep at the wheel. The next thing she knew, her car was wrapped around a pole, and she was being flung 50 feet back through the cold night air. Shannon resurfaced to find herself a paraplegic—"dead from the mid-back, all the way down". Her doctor told her she would never walk again. "I told him, 'I don't think so!'" Shannon recalls. "Oh, I can't wait to see him now! I'll walk in the door and say, 'How're you doing?' Now I can stand up with the help of callipers and I can use the rest-room like a normal human being!"

The turnaround took place, Shannon says, after just six weeks at Dr Geeta Shroff's Delhi clinic, Nutech Mediworld, where regular injections of human embryonic stem cells (hescs) were administered to her. She's not the only one to have been wheeled out of this clinic, dizzy with hope and exhilaration. A fortnight ago, Australian motivational speaker Perry Cross, a quadriplegic who'd been paralysed by a rugby accident at the age of 19, said he could breathe without his ventilator after two months of treatment from Dr Shroff. "I feel that by coming here, my lottery numbers have finally come up," he told the world media.


Dr Geeta Shroff

You'd think Dr Geeta Shroff, the architect of these miracles, and, according to her, 500 others as well, would be hailed as something of a genius, if not a Jesus. Instead, she's been labelled a "maverick" dabbling in "dangerous quackery" by the western media and medical establishment, ever since she declared three years ago that she'd used hescs to successfully treat 100 patients with a host of incurable and terminal illnesses—including Alzheimer's, multiple sclerosis, renal failure and cerebral palsy.

The medical establishment abroad agrees that certain stem cells contained in the "blastocyst" (a five-day-old human embryo) are capable of unlimited growth, and that their ability to differentiate into any tissue of the body may hold the key to a number of diseases we now consider irreversible and incurable, including degenerative conditions like Alzheimer's and Parkinson's.

Yet, despite the hype, the hope and the headlines this science generates, and the huge amounts of research money it attracts, it remains poorly charted territory due to the stringent laws restricting it in most countries, largely due to the ethical question of destroying a potential life to harvest embryonic stem cells. In India, hesc research and therapy isn't under legislation yet. There are only a set of non-enforceable guidelines, put into place in 2005 by the bioethics committee of the Indian Council of Medical Research (ICMR). The fact that India does not have legislation to regulate stem cell treatment is seen as a loophole or a "grey area of governance" abroad. But the occasional headlines that stem cell research generates abroad—about the uncontrollable neoplasias (cancers) it has unleashed in rats, for example—do seem to suggest that caution is far from unwarranted.

Dr Shroff, who had earlier specialised in IVF treatment for infertility, would beg to differ. She's certain that the criticism she's attracted is due to sour grapes from Western scientists consigned to labs, toiling over transgenic (not purely human) stem cell lines. Their refusal to acknowledge that the technology is ready for use on humans is financially motivated, she says, adding: "Anyone who's first is controversial, and I'm a woman, an Indian woman, and not a grey-haired woman."

"We're standing at the forefront of a new medicine that will change all medicine," she thrills.


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"Like when penicillin changed the world, and brought in the antibiotic era, and people no longer died of infections.... With hescs as the first line of treatment, the word incurable has to exit from the doctor's and patient's dictionary. My ready-to-use injections should be made available in pharmaceutical companies around the world, as easily as insulin or any antibiotic."

What irks the medical establishment, though, is that Dr Shroff hasn't disclosed what exactly these injections contain, in peer-review journals. Her defence: "What's peer, who's peer? Where do I have a colleague who understands what I do?" She's "totally above board", she insists, pointing out the reams of certifications her two clinics have been granted: ISO, GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices) and GCP (Good Clinical Practices). She adds she's adhering to ICMR guidelines, and has formed an ethics committee to clear each and every patient's case.

All that's different about her case, Dr Shroff says, is that instead of publishing in journals and exposing her work to "rubbishing and theft", she's applied for a patent to protect her research. With a touch of asperity, she exclaims, "I don't know what upbringing (Western scientists) have to speak out of turn when they don't know me or my work. Remember," she adds, "I'm a doctor as well as a scientist. They may be capable scientists who understand what goes on in the lab, but they don't know how to get it into a clinic. They're doing research, but they're all doing research on rats, on mice! That's the difference between them and me."

And that, says Dr Vasantha Muthuswamy, ICMR senior deputy director-general and head of its bioethics committee, is unfortunately all too true. "Our contention is that this is experimental therapy, it's not accepted as standard therapy anywhere in the world, so it should proceed as clinical trials. But according to Dr Shroff, it's regular treatment." The pretext of protecting intellectual property is no excuse for secrecy, she adds: "We're not asking for the process, we would just like to know what she's injecting into her patients. If it's stem cell culture material, that can be easily shown under a microscope, and it can't be stolen." Sighing, she says, "I'd be the happiest if she really cured these patients.... But we don't know what's been injected, or of its scientific outcome. So the problem is that Dr Shroff is treating humans as rats and mice."

Shannon, however, couldn't be a happier mouse. "I think it's a miracle and other people need to know about it. When I go back, I'm heading straight to the Veteran's Hospital, going room-to-room and recommending this treatment to everybody, personally." That ought to stir things up even further in this bioethical Pandora's Box.
http://www.outlookindia.com/full.asp?fodname=20080623&fname=Doctor+%28F%29&sid=1

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