Unfettered by regulation, India pulls ahead on stem cell treatments

NEW DELHI, India — In December 2007, Californian Amy Scher got on a plane to India, wheeled herself into the Nu Tech Mediworld hospital in New Delhi, and started the first phase of an experimental embryonic stem-cell treatment.

Her American doctor had warned her against this untested procedure. But 27-year-old Scher was making no progress with conventional medicine, and she was fed up with the constant visits to hospital emergency rooms.

Scher suffered from chronic Lyme disease, which had gone undiagnosed initially, causing serious damage her nervous system. After researching her options for months, talking to several people who had benefitted from these treatments in India, and reading up about therapies available stateside, Scher decided the American medical system couldn’t help her. She chose to travel to India.

For eight weeks, she was injected with stem cells and underwent extensive physical therapy. The treatments cost an average of $20,000 to $30,000 for a first round of injections. They were not covered by insurance.

Today, Scher’s U.S. physician, Dr. Steven Harris considers her "asymptomatic." He is uncertain whether the disease has been eradicated, or if it’s just dormant, but he says the treatments appear to have helped.

From India, Scher brought back a SPECT scan, which measures blood flow in the brain. Before India, Harris says, the blood flow in her brain was impaired. "At the end of her stay, a repeat scan showed normalization of her blood flow — in effect, an improvement in brain function." Scher no longer takes nerve stabilizers or cardiac medication. The chronic pain, a constant companion since 2001, is gone.

Unknown risks 

But some scientists and stem cell researchers in the West believe that patients like Scher are putting themselves at a huge risk by coming to India to get these experimental treatments. The problem, they say, is the lack of legislation governing the use of stem cells in the developing world.

The Indian Council of Medical Research (ICMR) allows the use of embryonic stem cells if the condition or disorder is considered incurable. But Dr. Satish Totey, Chief Scientific Officer at Stempeutics, a private stem cell company, and the Secretary of the Stem Cell Research Forum of India (SCRFI) believes there needs to be tighter regulation.

"There is nothing in those ICMR guidelines that can actually be called a guideline," he says.

Unlike in the West, there has never been a controversy about the manipulation or destruction of human embryos in India, giving the country’s doctors a head start in the field.

The growth of private hospitals providing stem cell therapies, however, is breeding a rift of a different kind. Given that most of these treatments have not been proven safe or effective, medical professionals dispute whether these clinics should be allowed to exist at all.

A controversial doc

At the heart of the controversy is Dr. Geeta Shroff, the doctor who treated Scher.

Being both fiercely independent and intelligent has earned Dr. Shroff the criticism and scorn of many. A pioneer in many ways, she developed a technology through which, by the use of a single donated embryo, she has been able to treat 600 patients for conditions such as Alzheimer’s, multiple sclerosis, renal failure, cerebral palsy, and diabetes. What’s also unique about Dr. Shroff’s technique is that’s she’s been able to grow embryonic stem cells without the use of any animal products.

Dr. Shroff converts the stem cells into a clear substance that can be injected into her patients. The treatments include four to eight weeks of injections with intense physical therapy. In a progressive disorder, such as multiple sclerosis, the aim is to first stabilize the patient, in order to stop further deterioration, and then eventually, to start rebuilding through the use of stem cells.

The greater the damage to the body, the longer it takes for the stem cells to start regeneration. In a static injury, such as a stroke or a spinal cord injury, the stem cells have to bypass the thick scar tissue and form connections around it. Patients who come seeking a "miracle cure," are often disappointed, she says. The stem cells need time to regenerate the body, and often take months or years depending on the injury.

Dr. Shroff started out as an infertility specialist. That, and her practice as a gynecologist, helped fund her early work, which was carried out in her garage. It also gave her insight into embryonic stem cells.

In the nine years that she’s been treating patients using this technology, she says that not one has reported any side effects. For GlobalPost Passport, several of her patients were happy to lay out their medical reports, wiggle their toes where they once had no feeling, and share details of their stay in the hospital — including complaints about the food. The scientific community, however, remains unconvinced.

In what is probably her most controversial move, instead of publishing her findings, Dr. Shroff decided to patent her technology. (Her patent application is available online.)

Totey says Shroff is taking advantage of her patients’ desperation. "Under the pretext of patents, she says that nothing can be shown," he says. "Why does she not publish a paper?" He believes that by not doing so, she is putting her patients at a risk of getting a teratoma — a type of tumor “that may contain several different types of tissue and sometimes mature elements such as hair, muscle, and bone,” as defined by medterms.net. (Teratomas are a common challenge for embryonic stem cell researchers.)

Initially, Dr. Shroff explains that she did think about publishing her results. "You do try and get out there and at the end of the day, I am a doctor," she says. She tried to present at some conferences, but was rejected and told that there were already too many people presenting on embryonic stem cells. That’s when she decided to patent her work instead. "With the patent, I could protect the technology. I could make sure that somebody who doesn’t understand the business can’t stop it." Once the patent is granted, Dr. Shroff will be able to move forward with the next step.

The dream, she says, is to make stem cell injections available in pharmacies across the world, so that the process of stabilization and treatment can be started right at the onset of disease. She likens it to the discovery of penicillin. "That was the beginning of the antibiotic era, and it changed the entire face of infection around the world. This is similar to that."

Favorable outcomes

Of her 600 patients, 30 percent are either doctors or have physicians in the family, she says. Despite her critics’ claims, Dr. Shroff says she has always put the well being of her patients first. An ethics committee at her hospital evaluates every case that comes in. The first two years, she says, were spent exclusively in the lab, testing repeatedly to make sure the treatments were safe.

In time, she’s sure the controversy will die out, as laws will come into effect. "It’s important to have certain guidelines or laws, but they shouldn’t curb research," she says. "The law has to be such that the work does not stop."

But Dr. Totey rejects proceeding with treatments before the science has been published and vetted. He points out that no one knows what she is putting into those injections. "If it is intravenous, I can use river water and inject that," he says. Until she shows the scientific community what she is putting in there, he says he’ll remain unconvinced.

Some doctors argue that the U.S. puts up too many barriers, and that India’s regulations are appropriate in allowing stem cell treatments for incurable and terminally ill patients. One such physician is Dr. Laurance Johnston, who in 2007 was the first American scientist to visit the Nu Tech Mediworld clinic.

Dr. Johnston’s credentials make him well-placed to judge: he is the director of the Spinal Cord Research and Education Foundations, Paralyzed Veterans of America (PVA); and he was formerly director at the Division of Scientific Review at the U.S. National Institute of Child Health and Human Development, a division of the National Institutes of Health (NIH). He told GlobalPost Passport that he’s convinced she’s sincere and conscientious in her endeavors.

"As you probably expect, there are a lot of politics, agendas, and economic interests when it comes to various emerging stem-cell programs," he says. "In general scientists think they are being good scientists if they point out what is wrong with a program rather than its potential."

Dr. Harris, Scher’s physician, is also impressed. After advising his patient not to go, and being pleasantly surprised on her return, he decided to travel to India himself to see Dr. Shroff’s work. "She has been able to accomplished two feats quite advanced in the field of stem cells," he says. "The ability to freeze and thaw her cells to allow storage and transport and the creation of an immortal cell line without animal feeder cells." Harris was most impressed with Shroff’s success treating patients with spinal cord injuries, and children with cerebral palsy.

According to a report by the SCRFI, India’s stem cell industry — including mainly research, but also stem cell therapies deployed by Shroff, and other stem cell therapies — is expected to grow at a rate of 15 percent, to $540 million by 2010.

"I think India is at the forefront of emerging stem-cell treatments in many ways," says Dr. Johnston. "Convinced of their superiority, American scientists hate the notion that the hottest breakthroughs may be happening in other parts of the world and vociferously denigrate them."

Dr. Totey agrees that it would be a mistake to base India’s stem cell guidelines on those of the U.S. "The way we work is different," he says. "We should look at our own system and make our own guidelines. There is no point in looking at the U.S. and thinking that they’re the best."

Scher, who spent years going in and out of U.S. hospitals, shares this sentiment. "I had really tried," she says. "I had tried all the traditional things, but I had also tried alternative therapies. And then, when you don’t have any of that left, you have to be open-minded. It’s ignorance to not look anywhere else. You can’t think that the U.S. has the only good treatments in the world.
 

Editor’s note: this article was originally published on GlobalPost’s premium content section, Passport. For more articles like this, please join Passport. 

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