A desperate Nashville couple pursues an expensive — and illegal — stem cell treatment in Tijuana
The High Cost of Hope
Dawn Gusty has the wide, toothy grin of a terminal optimist. At the moment, though, swallowed up in a plush brown leather chair 1,740 miles from home, she wasn't smiling. Her legs were skinnier than they'd ever been, and far more atrophied. Her tibias looked like rails pushing through her shins.
Still, Dawn couldn't help but daydream about all the things she would do again. Like letting the red electric scooter — her primary method of conveyance these days — gather dust in a closet. Like breaking out the old cane she had so meticulously painted in the early days of her disease, when she could still get around on her own two feet. The source of all her suffering, multiple sclerosis, is a complex and so far incurable ailment with a maddening lack of scientific understanding. Dawn's wish, by contrast, was simple.
"My goal is to use my cane and walk my kid into kindergarten," she said.
Dawn's is a particularly aggressive form of MS. It is characterized by a runaway immune -system response that causes nerve damage and, in the progressive stage, a rapid decline in mobility as the nerves that conduct signals from her brain to the rest of her body degenerate. Her doctors tell her the life she has now — constant pain, agonizing difficulty of movement — is as good as it's going to get. The treatments currently available in the United States don't work on someone as far along in the disease process as Dawn.
So the former Sony-BMG sales rep decided to leave the U.S. for Mexico, where she could buy a commodity in short supply back home: hope.
She paid dearly for it, too. By Googling "stem cells," she found an intermediary who would set her up for a controversial treatment that is currently outlawed in the U.S. The intermediary — a company called Stem Cells for Hope — charged Dawn Gusty $27,000. In return, she hopped a plane to San Diego with her husband John, her two boys and her parents. Upon landing, the Gustys took a Ford Econoline van across the Mexican border into Tijuana — a historically friendly destination for medical tourists.
The treatment would be an infusion of her own bone marrow — known to contain stem cells — into her spine, her veins and her muscle tissue. The idea behind the therapy is that an infusion of stem cells could regenerate the damaged nerve tissue in her brain and spinal cord. Repair the nerve tissue, the thinking goes, and maybe Dawn walks with her cane again.
The Food and Drug Administration decided to regulate this kind of bone marrow transfusion as a drug, or more specifically, as a biologic — a product of your body manipulated by the hands of men just enough to merit regulation and a double-blind clinical trial before it can legally see application in clinics and hospitals. Or at least that's the rationale.
Nevertheless, Dawn is but one patient in a medical exodus. Each year, thousands of Americans stream to far-flung clinics offering stem-cell-based therapies in Mexico, China, Indonesia, the Dominican Republic, Ukraine and Germany. The Stem Cell Research Forum of India expects the value of the stem cell market in that country alone to be $540 million this year.
It's nearly impossible to know how many such clinics operate in Tijuana, let alone the rest of the world. Their protocols, like the conditions they claim to treat, can be as various as they are difficult to verify — if the clinics will talk at all.
A large contingent in the research and medical community argues that stem cell clinics like this one are ruthless scavengers that prey on the desperation of patients for whom modern medicine has no ready answer. The U.S. medical establishment regards them as quacks who prowl the hinterland between theoretical promise and proven therapies, where hope, as they say, springs eternal, but well-founded doubt remains.
Proponents, however, argue the opposite: that Big Pharma and profit-driven research facilities stifle progress to protect their own products — and their own bottom line — while maverick physicians outside the mainstream are pursuing bold new treatments. Are broad, double-blinded clinical trials the only path to the development of safe and effective treatments, as much of the scientific community asserts? Or do clinics like these represent the kind of small-scale innovators that brought us in vitro fertilization, laparoscopic surgery and thousands of other surgical innovations, both good and bad?
The problem is, at the moment, there's no way to distinguish the innovators from the hucksters who populate any Google search, promising high-dollar miracles they can't deliver. And here sat Dawn Gusty, hearing for the first time there might be an answer to her plight — a way to halt the slow wasting of her body, and perhaps to make her walk again.
An estimated 400,000 people have MS in the United States — 2 million across the globe. According to the National Institutes of Health, 200 cases are diagnosed each week, at a cost to the nation estimated in the billions of dollars. Grave questions remain about how close we are to treating MS with stem cells. But that's not what Dawn Gusty was hearing. Her primary treating physician here, Dr. Gustavo Andrade, told her on the first day that he'd seen stem cell "miracles."
"We believe in God, and I have the faith," Dawn replied. "And I expect a miracle."
In pursuit of that miracle, the Gustys would hand over a large chunk of money. And a woman who requires a Herculean effort to lift her Crocs just one inch off the ground would load her walker and scooter onto a plane and travel to another country. Along with their money and most desperate wishes, Dawn and her family would place their greatest remaining asset — their faith — in a company about which little is known, a clinic in a troubling south-of-the-border industry of medical tourism, and a treatment many physicians regard as unproven at best.
Accompanied by a Scene reporter, the Gustys went to Tijuana, like so many others in similarly desperate circumstances, with something precious at risk: their last hope. Their experience confronts some of the bleakest questions facing patients who have exhausted conventional medicine, and who are vulnerable — infuriatingly, heartbreakingly vulnerable — to any promise of relief. No one can blame them for wanting what doctors back home tell them they more than likely will never have: the life they once knew.
About 15 years ago, Dawn Gusty was pounding up the long stairs at Riverfront Park when she noticed something wrong with her legs. Truth be told, they hadn't felt right in a while. The impact of each footfall made her thin frame feel like a truck without shock absorbers. Now there was more to it than that. She was always hurrying to the bathroom to pee. These things happen to someone twice her age, not a woman in her mid-20s.
She had only recently been transferred to Nashville after a brief stay at the Washington, D.C., office of Sony-BMG, where she was a sales rep. It was in D.C. that she'd first noticed a tingling sensation in her legs. She could ignore it no longer. Dawn saw a urologist about her urgent bathroom visits.
"Are you walking OK?" he'd asked.
"No, I'm not."
He ordered an MRI on Dec. 19, 1997. The next day, a neurologist reviewed her slides and showed her what appeared as dark spots, or lesions, on the otherwise light-colored brain tissue where nerve cells had been damaged. There were lesions on her spinal cord too. They were indicative of multiple sclerosis.
There were a few treatments that would manage the inflammation, she was told. She declined them.
As she left the doctor's office late that afternoon it was already dark. Dawn sat down on the front steps in the chill night air and smoked a cigarette — a habit she'd been trying to break.
"It really hit me then," she recalls. "This is big. This is gonna change my life."
A friend picked her up, yet suddenly she felt like a woman on a deserted island. Her parents were back in Colorado. Her boyfriend was in another country. But she decided this was something she would deal with on her own. She gathered up a few books on MS, and in those early days, through exercise and healthy eating, she believed she could keep it under control.
Days after her diagnosis, she boarded a flight to London to spend New Year's Eve with her boyfriend. He seemed to take the news well — until they stayed at a bed-and-breakfast. The owner had a cane, and one arm hung listlessly at his side. He had MS too. To break the sudden chill between them, Dawn's boyfriend remarked that it was good they were already together — you know, since dating could be tough for a "cripple." She laughed it off, or tried. Eight months later, he dumped her.
Dawn kept smoking and stopped taking care of herself. She continued working and living the life of a single woman in her 20s. She went to local punk shows, she partied, she tried to meet men. But as soon as she mentioned MS, potential romantic interests mysteriously metamorphosed into friends.
Life was getting harder, though. She was sore and exhausted more often. She started taking the drug Betaseron to manage the inflammation that causes the damage associated with MS. By 2000, she was prone to stumbling and falling. In a defiant gesture, she bought a cane and painted it black, accented with a curvaceous nude woman's body running its length.
She showed up to a house party for the first time with the cane. Everyone seemed to think it was a fashion accessory. But she meant it as an entrée to conversation, or, in this case, full disclosure.
"It was good for me to have a cane because it let people know I'm not drunk," Dawn recalls at the clinic in Tijuana, a translucent IV line in her arm. "I'm not just clumsy. It told everybody I'm not falling down because I'm not graceful. Something's wrong, See, I have a cane. Pay a little more attention to me. Part the way so I can get by. Give me some help."
More than ever, though, Dawn wondered if any man would love her, if she'd ever raise a family. It was then, as part of her business, she met John Gusty. Then manager of Tower Records on West End, John wasn't put off by an attractive twenty-something blonde leaning on a cane.
"You gotta understand, I spent most of my day getting people with blue hair and five nose rings just to show up for work on time," says John Gusty, whose longish brown hair, V-neck T-shirts and boots give him the air of an aging rocker. "So a hot woman with a cane wasn't that big a deal."
Back then, John was separated from his wife, and Dawn was simply the sales rep who had tried to convince him he should stock 500 records by some frost-topped former Mouseketeers called 'N Sync. Dawn adored him, though, and when she found out his divorce had been finalized, she admits she got a little excited. When he won sole custody of his son, Vann, she took the opportunity to congratulate him at a bonfire party with a six-pack of Guinness and flowers. His eyes widened, she remembers, as though he were looking at her for the first time.
"You should be worshipped," he said. He asked her if she were "taking any applications for boyfriend." He raised his hand.
"If you're ready to fill one out, I'll take it," she replied.
By 10 a.m. the next day, John was on the phone. "You've kept me up all night long," he confided. They met for lunch that day. He asked her if his having a 4-year-old son scared her. She asked him if her MS scared him. He told her it didn't. With him, he said, she'd have an extra pair of eyes, hands and feet.
From that point, the relationship progressed quickly. Within a year, they were living together. It wasn't long before they married. She gave birth to a boy, Reagan, named for a hero of John's: the late Ronald Reagan, the emblematic American optimist.
At what should have been the happiest time of their lives, the power of their positive thinking was soon severely tested.
By 2003, Dawn's condition was gradually worsening. She lost 45 pounds. She had trouble getting out of the car. She asked John again if this scared him. Her decline was becoming so obvious, he could only admit that it did.
Neurologists theorize that a threshold effect comes into play with MS. Deterioration will often be slow and steady until a certain critical mass of damage is reached. Dawn could measure her decline in support vehicles. When the cane wasn't enough, she got a walker. When walking more than short distances became too difficult, she got an electric scooter. She began to notice more weakness in her arms, especially the left one. MS is a link-dependent disorder, meaning it progresses from the feet up like fast-rising floodwater.
What makes MS so frustrating, and so hard to fight, is that the floodwater doesn't rise the same way in every patient. If the central nervous system is a giant mass of electrical wiring, the axon — the slender projection from the nerve cell that acts as a transmission line, sending signals from nerve cell to nerve cell, and nerve cell to muscle — is essentially the wire. The insulation is a protective fatty layer called myelin.
When myelin gets damaged, the electrical impulses aren't carried by the axon as well, if at all. This causes lesions to form on the brain, and up and down the spinal cord. For that reason, one of the few sure ways to diagnose the disease is with an MRI.
Doctors do not understand exactly what causes the immune system to begin attacking the myelin, the root cause of MS. Scientists theorize that the immune system goes into crisis mode in certain people when they're exposed to an infectious agent. But they have been increasingly successful at slowing the disease by tamping down the immune response. Slow the inflammation, and in some cases the myelin may be able to repair itself.
But the disease doesn't affect everyone the same way. In certain cases, the body can effectively reinsulate the axons, allowing the patient to go on to lead a normal life — perhaps having never been the wiser. A certain subset may not replace the myelin as quickly, and over the years they'll work through a series of flare-ups with symptoms (known as relapsing-remitting MS). But relapses usually can be managed with drugs that lower the inflammation-causing immune response. Sometimes, after years of this seesawing, the patient will go onto a more progressive phase of the disease, meaning they might end up more like Dawn.
Then there are patients exactly like Dawn, whose disease processes have been less a series of ups and downs than a steady decline. For reasons that polarize researchers, Dawn's form of the disease — primary-progressive MS — seems to be less characterized by inflammation. By some mechanism that remains up for debate, Dawn's axons — the wires within the myelin insulation — are being destroyed. Because of this, getting her immune system to stop its attack and repairing the insulation will do no good. The wire itself is being corroded.
Scientists believe the next big advance in the treatment of someone like Dawn Gusty will come from answering this question: Does the immune-response inflammation cause the damage to her nervous system — or does the damage (by some unknown mechanism) cause the immune system to go haywire? It's a chicken-or-the-egg conundrum.
There's a high bar to clear, though. Neurologists believe nerve cells and axons are formed as early in human development as the first trimester. They also believe those cells are hard-wired — and thus perhaps impossible to repair.
Small wonder that as the effects worsened, the Gustys clutched at any straw that looked like a solution. Dawn underwent an unusual therapy in Tulsa, Okla., that claimed by using "light, sound, frequency and vibration within the Life Vessel, the body is able to de-stress and detoxify to an unusually high degree. Also balancing the Sympathetic and Parasympathetic parts of our Autonomic Nervous System is the key to having optimal functioning of the immune system."
There was just one major problem. Assuming the "Life Vessel" could even do what it claimed, at this stage Dawn's immune system was not the issue. The therapy had no effect.
For this, the Gustys paid $3,000.
Then in early 2009, Dawn's father Dave Cooper told her he'd seen a story online about a man who'd gone to Costa Rica for a stem cell transplant and had some improvement. The treatments were expensive, though, and John was doubtful.
Even so, they spoke with a doctor offering human embryonic stem cell therapy. As the doctor said, embryonic stem cells are the most "potent" stem cells, meaning they have the potential to differentiate into cells that make up almost any organ in the human body. But they also represent an unwieldy wild card researchers have yet to harness. They can just as easily differentiate into a tumor.
The Gustys found it was difficult to raise money for any treatment that utilized stem cells from a human embryo. That wasn't the half of it. Later, the Gustys discovered the clinic was associated with the Raelians — a cult that believes humans are descended from aliens.
So Dawn began looking at adult stem cell therapies. She did a Google search, and a name appeared on her radar: Stem Cells for Hope. The Gustys spoke with representatives from the company, which is based in New York. In turn, the Stem Cells reps put them in touch with people who said they'd had the treatment and claimed miraculous outcomes.
John remained skeptical. He struggled to strike a balance between prudence and dashing his wife's hopes. Dawn, on the other hand, was sold. She started her fundraising efforts in earnest, launching a blog and setting up a Facebook page.
Within several months, she'd raised $30,000. It couldn't have happened soon enough. By this time, the dull ache in her limbs had increased to shooting pains. Her fine-motor skills were diminished. Routine tasks such as handwriting and typing had become minor ordeals. She placed the call to Stem Cells for Hope.
No one can put a price tag on hope, but Stem Cells for Hope came up with a figure: $27,000. It would include the treatment, the Gustys' hotel stay, and transportation to and from the clinic. Shortly before she was to depart for Tijuana, Dawn made an appointment with her neurologist to document her condition before the stem cell treatment. He told her he couldn't support what she was doing. It was unproven, he said, and potentially dangerous.
No treatment had helped her condition so far, she replied. "Can you blame me?"
No, he said. He could not.
On June 27, Dawn, John and their two bleary-eyed boys boarded a plane bound for San Diego in the weak morning light.
No signage marks the slick Tijuana office building that houses the Institute of Chronic Disease, where Dawn Gusty sought her treatment. On the second floor you'll find an oncologist's office, but the sign on the door does not bear the name of Dawn's primary physician so far. Past a window printed with scripture from Matthew 9:22 — "Your faith has healed you" — there's an expansive room painted a brilliant white.
Outside, from the floor-to-ceiling windows along one wall, a line of people could be seen stretching down the cracked concrete sidewalk all the way down the street to the U.S. Consulate — petitioners seeking work visas. Beyond, the gunmetal steel skeletons of half-finished buildings rose out of the palm-lined streets and above Tijuana's dun palette.
Inside, Dawn Gusty struggled to her feet, using her triceps and what little strength remained in her quadriceps, and steadied herself with a walker. When she took a step, her legs were like stilts: inanimate things beyond her control. With the poor nerve conduction, it's like they're cast in lead, especially the left leg — one side is usually worse in people with MS. A few years ago, this wasn't nearly as difficult.
"There are moments when I'm hurt and tired," Dawn said. "But I look around and I think, man, life's good. What will that feel like when I feel good?" She settled back into her chair.
When Dawn asked Stem Cells for Hope if she could bring a reporter, the answer was an unequivocal no. (The Gustys decided to introduce me as a friend, and I made follow-up calls as a reporter.) She was told that the organization — which is not connected to the clinic —didn't want to cause her doctor problems with the Mexican government. And not without good reason. There remains a certain out-of-sight, out-of-mind relationship between the Mexican government and clinics offering therapies that in most countries remain unapproved.
Since the ratification of the North American Free Trade Agreement, the Mexican government has been more willing to cooperate with the United States in policing cross-border health fraud, cracking down on clinics peddling therapies the FDA and the Federal Trade Commission deem unproven. The most visible targets have often been clinics run by U.S. expatriates. Nowadays, Mexican law requires that a Mexican citizen play a prominent role in the management of health clinics.
How strictly this is enforced is up for debate, though. In 2002, the San Diego Union-Tribune asked Dr. Alfredo Gruel Culebro, a former Baja California health official who led a 2001 crackdown on cancer clinics offering unproven therapies, how many unlicensed or inadequately licensed clinics there were in Tijuana. Even he could offer no better estimate than "between 30 and 70."
For Dawn's first day of treatment, John stayed with her at the clinic. Dawn's father, Dave Cooper, and her mother waited a short drive away at the hotel, watching as the Gustys' two boys frolicked in the courtyard and pool. The grandparents tried to maintain the festive mood of a vacation, but as late afternoon shadows crossed the grounds, Dave could not hide his uncertainty.
"I was a science teacher," said Dave, a towering, laconic man who, in retirement, works as a runner for a local laboratory. "I don't understand how this is supposed to work." He'd gone to a seminar on stem cells recently. When it was over, he approached the speaker about his daughter's travel plans, to get his opinion.
"What I heard wasn't good," Dave said. "I haven't had a real gut-level talk with Dawn." He looked down at his shoes.
Moments later, a faint whirr began to grow louder by the other end of the pool. It was the sound of Dawn's scooter. Her family looked up with anticipation — then concern. Dawn was slumped over the handlebars, visibly ill. Reagan, her adoring 5-year-old boy, ran to her with his long hair flying. They embraced for a long time. Reagan looked up at his mommy.
"Are you fixed?" he asked.
"Not yet, honey," Dawn said.
The problem was that no one had told Dawn there would be a grueling first step in her treatment — chemotherapy. She was not alone. Another woman who told the Scene she was being treated for MS at the clinic said the chemotherapy was a grim surprise. When asked about the matter, Stem Cells for Hope co-founder Peter Sidorenko told the Scene his company goes into "great detail" to prepare patients for what they'll face.
Pressed to explain, Sidorenko said he'd given Dawn the contact information for a former patient. "Whatever they discussed," he said, "hopefully they got into that."
This wasn't the only snag the Gustys had hit on their first day. The treating physician, Dr. Gustavo Andrade, was visibly irritated when he found out that Dawn hadn't been told to bring her MRI slides so he could see the lesions on her brain and spinal cord. Yet because of the way Stem Cells for Hope works, there's no way Andrade could have let the Gustys know the slides were needed. Stem Cells for Hope acts as a brokerage between his clinic and the patients — a middleman.
It also acts as a wall, patients say. When Andrade receives patient documentation from Stem Cells for Hope, he says, it contains no phone number, no email address, no contact information whatsoever. By design, his patients don't get to speak to him until they're in Tijuana and the treatment has been paid for — presumably so Stem Cells for Hope doesn't get cut out of the deal.
John Gusty, however, was all ebullience as he sank into an adjacent patio chair with his laptop.
"I was a skeptic before, but if I had doubts, I'm at ease now," he said, talking a mile a minute. Though the treatment was wearing, John thought it would be a success. The setting sun gleamed in his aviator sunglasses. He had two days' worth of stubble, and his crow's feet deepened as he squinted as the notes on his laptop.
Dawn rolled up on her scooter with Reagan in her lap. She was trembling. It was balmy out, and while the rest of her face was an ashen gray, her cheeks looked chapped, as though she'd just come out of a strong wind.
"I'm woozy," she said, and leaned on the scooter's armrest.
Dawn would spend the rest of the night shivering uncontrollably as her body reeled from the chemotherapy's toxins. When she was shaking so badly she thought she'd bite through her tongue, John placed his wife's thin body, now impossibly fragile, in a hot shower.
Two days later, Dawn and John rode the elevator up to the clinic. She hadn't eaten much since the chemotherapy. She was nauseated and had an unshakable headache.
"Today's gonna be a good day," John said.
Dawn's scooter was pointed at the corner, her head bowed. "Yep."
Once she settled into a leather recliner, Dr. Andrade strode into the room. He was a short man with heavy-lidded, pale blue eyes and a paunch that showed through the spaces between the buttons of his snug shirt. He bent over and felt her forehead, her cheeks and rubbed her shoulder as his necktie swayed.
Andrade said he had specialized in cancer treatments for most his career at the Oasis of Hope Hospital in Tijuana. Founded in the early '60s by a Mexican army pathologist, Oasis was one of the original cancer clinics offering alternative therapies that were illegal in the U.S. Specifically, it offered a drug called Laetrile — a substance derived most readily from apricot pits, and once touted to have astounding cancer-curative potential.
For many years, controversy swirled around the latest cure du jour that the U.S. government allegedly didn't want stricken cancer patients to have. Desperate gringos streamed across the border by the thousands. But a study published in 1982 in the New England Journal of Medicine found that of 178 cancer patients treated with Laetrile, the drug hadn't cured any of them. Not only hadn't it stabilized the patients, it hadn't even improved their symptoms. In fact, several patients had near-lethal levels of cyanide poisoning from the substance.
Now commonly known as "Vitamin B-17," Laetrile is still available at Oasis today.
"Everything will be OK," Andrade said, stroking Dawn's head. "Nothing to worry about. Everything to gain."
"I believe it," Dawn replied. In a few short hours, she would receive a bone marrow transfusion, populated, she was told, with millions of her own stem cells. To Dawn, they might as well have been a jolt of life itself.
Finally, she was led down the hall to the operating room. John shuffled behind, holding her IV bag. The operating room was small and sparsely appointed. There was a hole in the drywall. After anesthetizing her, a surgeon carved a small hole into her tibia, below her knee. Then what looked like a turkey baster was used to extract the red, viscous marrow.
Over the past few days, Andrade said, he'd been giving Dawn several different growth factors. Among these was human growth hormone, which spurs plasticity in the bone marrow, he explained, causing the stem cells within to assume the ability to turn into a number of different tissues. According to Andrade, these would include the neural cells damaged by Dawn's MS.
He then infused the marrow into her spinal canal and into her veins through an IV — a mixture he claimed was now rich in multipotent stem cells. The stem cells, he said, would travel to the brain because he'd given her a drug that disrupts the blood-brain barrier. This is the layer of cells that protects the central nervous system and its surrounding fluid from blood circulating through the body, which may carry common bacterial infections. He explained that through a process called cellular fusion, the stem cells would attach themselves to the damaged neural cells and repair them.
Asked if there were a study or clinical trial he based his therapy on, Andrade did not offer specifics. "It is a lot of papers on the Internet of studies from all over the world," he said. "You check on the Internet and type in bone marrow, multipotent stem cells, they'll give you a lot of a papers."
The next morning, another patient asked Dawn if she felt better since the procedure.
"I do," she said, holding her thumb and forefinger together. "But it's small."
"I think she's being cautiously optimistic," John said. "She was in the bathroom this morning doing this." He stood up and held his arms straight out in a yoga pose.
"But it wasn't very long," she said.
"She didn't wake up this morning doing karate," John conceded.
"I was lying in bed feeling yucky," Dawn said, "and I looked at John and I wanted it to be like night and day."
When John got a text message from their older son Vann, saying that everyone wanted to know how Dawn was doing, he asked her what he should say. "Tell them it's slightly ..." she began, then corrected herself.
"Tell them I'm good."
The journey undertaken by the Gustys and other MS sufferers takes place against the backdrop of larger medical questions about the role of stem cells in treating MS. When it comes to stem cell therapies targeting the disease, two are being actively investigated.
The first, outlined in a study by Dr. Richard Burt in The Lancet Neurology, offers patients with relapsing-remitting MS low doses of chemotherapy, along with a type of antibody called alemtuzumab or antithymocyte globulin. This antibody is often used in concert with chemo to help prepare the body for bone marrow transplants. The transplants fight leukemia by destroying malignant blood cells, replacing them with healthy, blood-forming stem cells derived from bone marrow and other sources.
Burt essentially applied the same principle to MS. The doctor gave patients the chemo, essentially triggering the release of new blood-forming stem cells from the bone marrow. These were filtered out of the blood and collected, using a process known as apheresis. Patients were then dosed again with chemo along with the antibody, which would, in effect, reset the immune system and clear niches for the new blood-forming stem cells. The stem cells, cultured and purified, were then reinfused intravenously.
Three years after the transplant, each participant's MS had either improved or remained the same. It should be noted that a handful suffered relapses, but these were treated successfully with more chemo.
This was by no means a new protocol, but it was the first time it'd been tried with a more moderate immune-suppressing regimen. A previous trial was halted because the participants were dying of opportunistic infections they had no ability to fight. Burt's regimen was no walk in the park, though. In the interest of safety, the participants were hospitalized for 11 days.
But while the treatment seemed to be very successful, one big question hung in the air: What exactly calmed the dysfunctional immune systems of the participants? Was it the stem cells? Or was it the drugs? Either way, the goal was to give a new immune system to a relapsing-remitting MS patient whose own immune system was attacking the body's nerve cells. But inflammation and damaged insulation of the nerve fibers weren't the problem for Dawn. Her nerve fibers, or axons, themselves were damaged, and Burt's protocol could do nothing to address this.
The Scene asked Dr. Jakub Tolar, an associate professor at the University of Minnesota who studies bone marrow and cord blood transplants and stem cell therapy, how feasible Dawn Gusty's treatment seemed, going by a list of her prescribed medications and dosages and a detailed eyewitness account of the procedure. Since the clinic was using the same mild form of chemotherapy given to Burt's patients, Tolar said it sounded as though they were attempting to mobilize the stem cells from her bone marrow — no surprise given Andrade's background at Oasis of Hope, which treats many cancer patients.
But if that were the case, Tolar said, there were a few steps missing. Without the subsequent chemo and alemtuzumab, the immune system wouldn't be sufficiently suppressed. Nor would the niches — soon to be filled by the new blood-forming stem cells — be vacant.
When I asked Dr. Andrade about his rationale for the chemo, he said, "All MS patients have inflammation, and you know that beta interferon, Copaxone and all those medications are trying to regulate the immunity. This is an inflammation problem. If you lower the immunity you can manage the inflammation."
That would be true if Dawn had relapsing-remitting MS and her problem was inflammation. But it wasn't. Hers is primary-progressive MS, where axon damage is the issue. "It is possible that the reason they didn't [use alemtuzumab or antithymocyte globulin] is these are expensive medications, and the side effects are greater because the more immuno-suppressed these patients get, the more side effects you get," Tolar said. "You get the benefit, but you get more side effects."
Put simply: As bad as Dawn felt the night John placed her trembling body in the hot shower, she would have felt even worse had the clinic been using the expensive antibodies. She would have been hospitalized, like Burt's patients.
But the choice of a little stand-alone chemo puzzled Tolar and other researchers less than Andrade's decision to inject the bone marrow into her spinal column. Nor did it explain his assertion that the stem cells would engraft to and repair Dawn's damaged nerve cells.
This process is the basis for the second kind of potential stem cell therapy for MS: mesenchymal stem cell transplantation. Mesenchymal stem cells are located within the bone marrow. They are thought to be able to differentiate into various kinds of cells — potentially even neural cells, some say, though this is still a matter of hot debate.
In rodent studies where the animals were induced into an autoimmune disorder that mimics MS, mesenchymal stem cells have shown properties that can possibly modulate the immune response and encourage the growth of the myelin. But there's been very little evidence to suggest that the stem cells in question accomplish any of this by differentiating into neural cells, much less fusing with them — a phenomenon Tolar said is incredibly rare.
Regardless, it's yet another potential therapy that could one day be of some use for folks with relapsing-remitting MS. But for Dawn's disease, it represents yet another dead-end. So what, then, was Andrade trying to do?
"What surprised me was the amalgamation of everything you saw," said Dr. Timothy Coetzee, an MS researcher and president of the MS Society's philanthropy arm, Fast Forward, when given the same information about the procedure as Tolar. "What wasn't clear to me is what's the purpose of combining all those things together?"
Told that Dawn received an intramuscular injection of the stem cells the day after the procedure, Dr. Tolar was aghast. "Oh, that's incredible," he said. "So these cells are obviously dead almost immediately. They don't even make it into the blood. They stay there and immediately get chewed up by the enzymes in the tissue. There's nothing left of them."
Asked for his assessment of Dawn's treatment, Tolar was frank.
"I'm trying not to be hypercritical, but these people aren't even wrong," he said. "They are so outside the system of right and wrong, I don't have anything to measure anything about what they have done. First of all, they are mixing together things that typically would not be mixed. So even if they did see an effect, the confounders would be so severe it'd be impossible to decipher which thing worked and which didn't.
"Second, they're not using these medications in the proper way, so that tells me right away that's not their intent. Their intent seems to be to do something that does not cause many side effects."
It was Dawn's last day in Tijuana and there were errands to run. Andrade said he wanted Dawn to have a supply of Neupogen, a drug used to stimulate white blood cell growth, along with some human growth hormone to take home. But there was a catch. Out of the $27,000 the Gustys had already paid, the doctor said, Stem Cells for Hope hadn't paid him enough to include the drugs.
So John and Andrade hopped into his Land Cruiser, an older model with a cracked windshield, and jockeyed into Tijuana traffic, where lanes were mere suggestions and rank aggression was rewarded. They pulled up to Pey-Pharma, near the Banamex off the congested Paseo de los Heroes, and made their way through a drug store not unlike your average Walgreens. Except your average Walgreens doesn't have a set of back stairs leading to a small, windowless room. One man stood behind a counter. Another stood at their side, watching.
How much would Andrade have charged if Dawn had come straight to him? About $14,000, he said. Even factoring in the driver taking them to and from the clinic, and the hotel stay, did that mean Stem Cells for Hope was taking $10,000 off the top? The question was put to Stem Cells co-founder Peter Sidorenko, along with what his brokerage's take was.
"The problem we always have with Dr. Andrade is he is a wonderful doctor, and brilliant in his ability to come up with these treatment protocols ... and his bedside manner is phenomenal," Sidorenko said. "Unfortunately, Dr. Andrade has absolutely no business sense, if you will."
Sidorenko did say that Stem Cells paid a significant amount to Google for web-search position, and that they had employees to pay — though when a call was placed to the Stem Cell offices, Sidorenko himself answered the phone.
As John made his way downstairs to the drugstore cashier, the quiet man who'd been watching him followed. He leaned against the counter as John handed the cashier his credit card. When John's bank balked at a sizable out-of-country purchase, Andrade put it on his account. He told John he could write him a check.
Within the hour, the Gustys were back in the Econoline van, headed for the border. They passed whitewashed walls covered in graffiti. They passed taquerias, peluquerias, carnicerias and dentistas in strip malls along steeply sloping streets, where women swept with straw brooms. They passed the occasional gaggle of Mexican soldiers looking bored and sitting in the beds of Chevy single-cab trucks, clad in desert camo with M-4 rifles slung over their shoulders.
The line of cars going into the United States was long and stalled (though the one going out, the Gustys noticed, was clear). A young man stepped into the next lane and started juggling flaming rolled-up newspapers for spare change. The driver veered toward a less congested crossing. She drove along the razor-wire-crowned border fence separating San Diego and Tijuana, twin cities where money and people and drugs pass back and forth, as though their economies were one.
Dawn Gusty was on her way home.
On Oct. 5, some three months after her return from Tijuana, Dawn and John sat in her current neurologist's office at Vanderbilt Health at 100 Oaks. Her condition had improved, she said — or at least she was slightly better than she had been before going to Tijuana. But after about five weeks of somewhat reduced discomfort and increased mobility, she said, she began to "slip." At times, she thought her MS was as bad as it had been before the treatment.
There may be no way to know for sure whether the therapy she received actually helped. MS patients are notoriously sensitive to the placebo effect. An emerging field of study has in fact grown up around the phenomenon, looking to harness the brain's power — literally, wishful thinking — in treating neurological disorders. It may also be no coincidence that she began to slip when she temporarily ran out of the human growth hormone they brought back from Mexico.
Nevertheless, Dawn and John told her neurologist, Dr. Harold Moses Jr. — also a researcher and a professor of neurology at Vanderbilt University — that they planned to go back for at least two more treatments, recommended by the clinic. The doctor struck a delicate balance, registering his doubts without driving her away.
"I heard the negative side of it, too. Before we left, my dad went to a talk by a doctor who was very savvy about stem cells," Dawn told him. "And my dad said we're going to Mexico and the doctor said, 'Don't go. You're pissing in the ocean.'
"So there's that side, and I understand that. But for me, I did it. This was my hope. I put that stuff aside. I had to have faith."
She explained to the doctor that she no longer expected a miracle, a panacea with an answer for every ill. "This is the lesson I learned," she said. "I actually thought I'd go down there and they'd shoot me up and I'd hop off the table and say, 'See you later.' "
Moses' mouth was agape. He blinked hard. "Did you really think that?"
"Yeah."
"Seriously? Wow." Moses asked her if she'd ever heard of CCSVI. She said she had. It's a condition that has been suggested as a cause for MS, which an Italian vascular surgeon claimed he could relieve using tiny balloons to dilate clogged arteries. Many MS patients, frustrated by the plodding pace of research, lobbied the MS Society hard to pay for studies. Foreign clinics began to offer the procedure, and The New York Times profiled a woman who found a willing doctor in Buffalo.
The first time it was done, the woman claimed remarkable improvements. Within a month, though, the Times reported she had difficulty walking again. She had the procedure performed again. And again. And again. Moses put it kindly but bluntly: Was that what Dawn wanted — cycle after cycle of costly treatment, with probably diminishing returns?
"I was there and there was significant improvement," John said. "Something improved her."
Moses clearly didn't want to dash the Gustys' renewed hopes. But the question remained: Given her current condition and the disability scores she earned by covering a certain distance in a certain amount of time, had anything changed?
"She felt better after she came back, but I can tell you the way she looked at our office visit was not very different from the visit before she went down there, and I think she kind of acknowledged that," Moses said. "You don't want to take away people's hopes, but I'm obligated to tell them the truth.
"The greatest unmet need in MS is to help people with primary-progressive and secondary-progressive MS, and people like me know it. We understand this is a huge deal and we are falling short in helping people with this problem."
In a last sad irony, Dawn's grasp at one chance may keep her from sampling others. According to Moses, participation in unapproved stem cell therapy, such as her trip to Tijuana, would exclude her from any promising clinical trials coming down the pike. So what is the best that state-of-the-art medical science can give Dawn Gusty to hope for as time wears on? Dr. Moses' answer is as succinct as it is crushing.
"Immobility."
How odd that Dawn Gusty should have to seek a new lease on life in a city that notches up 600 killings a year to drug cartels. At times, cruising through Tijuana with the Gustys, it made little sense that this frail woman would have to leave the country for a medical treatment that, effective or not, could be attempted in a clinical setting. After all, where MS is concerned, there is no shortage of patients willing to lay odds on the chance, however slim, that they might lead a more normal life.
That is exactly why the International Society of Stem Cell Researchers condemns, in most cases, for-profit treatment of patients using stem cell therapies. The ISSCR recognizes that there's a place for medical innovation, but asserts that unless strict guidelines are adhered to, the potential for exploitation is too great.
But as an article in the journal Cell Stem Cell made abundantly clear, such cold-eyed realism about the risks and benefits seldom seeps onto the websites of stem cell clinics attracting patients with gauzy portrayals of success rates with cherry-picked testimonials and downplayed risks. Some 74 percent of websites surveyed made no mention of risks. Stem Cells for Hope's website explicitly states there are no side effects.
David Audley, executive director of the International Cellular Medicine Society, wouldn't argue with many of the ISSCR's basic requirements for stem cell innovators. But he believes blanket condemnation of for-profit MS clinics whose treatments haven't been through the clinical trials process does little to address the problem.
"If people try and close them all down, the result is going to be that the ones that are able to hide are going to stay open," he said.
A watershed case, however, could be heard next summer by the U.S. District Court of Washington, D.C., where the FDA filed for an injunction to stop a Colorado clinic from administering stem cells to treat orthopedic injuries like broken bones and torn tendons. If the FDA wins, the status quo remains and stem cell therapies will plod through the clinical trials process like any other drug. If the clinic wins, autologous stem cell transplantation (using a patient's own stem cells) could be treated as a one-to-one surgical transaction between a doctor and a patient — and outside of the FDA's jurisdiction.
There is one thing everyone can agree on: Stem cell therapies are a billion-dollar industry springing up across the globe, and desperate people will pay almost any price to get them. It's far too late to close Pandora's box. And yet for Dawn Gusty and other MS patients facing a countdown to a slow, painful fade while research labs drag their feet, that box can't open fast enough.
Last Sunday, the Gustys said goodbye to their children and Dawn's parents, then stepped into the terminal at Nashville International Airport. As of press time, Dawn Gusty was in Tijuana for her second round of stem cell treatments.
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