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Family pins hopes for son on stem-cell shots
http://www.palmbeachpost.com/health/content/local_news/epape...
By Stephanie Horvath
June 19, 2005
TIJUANA, Mexico ? Slowly, patiently, Dr. Fernando Ramirez del Rio slides on a pair of latex gloves.
A nurse tips a 1-inch long vial out of a Ziploc bag and into his palm. It's frozen and white. Ramirez says it contains about 1.8 million stem cells.
He says it will take about 10 minutes to thaw the tube using the warmth of his hands. He then has 20 minutes to use the cells before they spoil.
He passes the vial to Judy Susser, who looks nervous. She takes it, rolls it between her hands. Then Ramirez offers it to her husband, Gary.
"It's time to give energy," Ramirez says. Gary touches it quickly.
A few minutes pass, and Ramirez holds the vial up to the light to see if it has thawed. The liquid inside glides easily up and down the tube as he
tilts it. It is perfectly clear, like water.
The nurse unwraps a needle, the kind diabetics use to inject insulin. Judy lets out a big sigh.
Ramirez sucks stem cells into the syringe, taking in 1.6 milliliters.
Judy looks away, covering her eyes with one hand. Gary lays their quadriplegic son, Adam, out on the bed, keeping his head close to his son's. He
begins to sing The Cat Came Back, one of Adam's favorites. Adam laughs.
Ramirez inserts the needle below the boy's belly button and pushes the plunger, thrusting the umbilical-cord stem cells into the tissue just under
Adam's skin. Adam's laughter turns to silent tears.
"Breathe, breathe. You're OK," Gary says.
The 4-year-old Boca Raton boy finally begins to cry in loud, full sobs. Tears run down his cheeks, and his skinny stomach, still exposed, contracts
with each heaving gasp.
"You're OK, you're OK. You want a beer? You want to go to Disney?" Gary says. He gives Adam raspberries on his cheeks. He picks him up, trying to calm
him and puts him in Judy's lap. His crying slows. Tears streak his cheeks and his nose runs. Judy holds him.
A vacation and a medical odyssey
Hope. It may be the only thing that Judy Susser holds onto as tightly as Adam, who has cerebral palsy. Hope that he will challenge his father to a
game of hoops. Hope that he will play soccer with his healthy twin brother, Brandon. Hope that he will one day hold her as as she holds him.
The Susser family's recent trip to Mexico, which began with a flight to San Diego, is part family vacation, part medical odyssey. On Saturday and
Sunday they took a harbor cruise and went to Sea World. On this day, Monday, they drive to Tijuana so Adam can receive a stem-cell injection that his
parents believe will help their son heal. No matter that U.S. medical experts see this as a fool's journey.
It is the third time the family has made the cross-country trip from Boca Raton, paying $6,000 for each injection, because the procedure is not
approved in the United States.
At 12:30 p.m., the Toyota van swings into the Centro Medico parking lot. Gary emerges from the back seat carrying Adam, limp as a rag doll, in his
arms.
The mud-brown seven-story medical office building stands alone, easily spotted from the U.S. border crossing about a half-mile away.
After a quick elevator ride, Gary, Judy and Kevork DerAlexanian, the van driver, walk into Suite 203. DerAlexanian carries a small turquoise cooler
containing a frozen vial of stem cells bought from a U.S. distributor and brought across the border in the van. If the cells were shipped to the
doctor's office in Tijuana, they would spoil before Mexican customs officials would release them.
In the waiting room, Gary sits with Adam in his arms. Judy sits stiffly, her arms close to her body, next to a bookshelf holding a television/VCR, a
collection of movies including Highlander and a large fish tank full of brown, thick water. But no fish.
"Are we in Boca?" Gary says, looking around the peach-colored room. "No."
Dr. Ramirez walks in. There are handshakes and hellos.
"I try to get used to it. Everytime I come here, you get the same emotions," Judy says while her husband and the doctor talk. "It's happy and
apprehensive and all that."
Twins on 'same track emotionally'
Their preparation for the day trip across the border to Tijuana began about 10 a.m. in their San Diego hotel suite.
Sheila Anderson, the family's nanny, pours a mixture of nutritional supplement, protein powder and muscle relaxer into Adam's feeding tube to
supplement his breakfast oatmeal. Gary, Judy and Brandon fetch breakfast from a local restaurant, bringing back sandwiches in white bags.
Judy checks on Adam, asking Sheila what he's eaten. She kneels down, brushing his long brown hair off his forehead and kissing him. Adam snorts. She
snorts back.
The driver is supposed to be there by 11:30. Until then, the family kills time.
In the living room, Brandon, who will be 5 in next month, eats homemade tortillas and watches Cartoon Network. While his brother goes to Tijuana for
the experimental treatment, Brandon will go with Sheila to Old Town, the historic district of San Diego adjacent to the hotel.
"Both are on the same track emotionally," Gary, a Boynton Beach-based trial lawyer, said of his sons. "Physically, they're different. Mentally, we
think they're the same."
Brandon developed normally. There were problems with Adam's birth at Coral Springs Medical Center, and he suffered brain damage. He was born blind,
paralyzed and with cerebral palsy. The family received an undisclosed amount as a settlement; that money pays for their trips to Tijuana.
Judy and Gary got married in 1997 and tried right away to have children. After seven tries with artificial insemination, Judy conceived twin boys
through in-vitro fertilization.
Gary says he and his wife have a decision to make ? whether to give the stem cells to Adam in a shot or in an IV tube.
"This time we want to do the IV. It depends on if his veins are good," he says. Gary says the doctor has told him the intravenous method could help
Adam heal faster.
Healing was what the Sussers were looking for when another Palm Beach County family told them about a doctor in Mexico who had helped their daughter.
Gary and Judy looked at their son, who could not speak, see or move, and decided they had little to lose.
Adam slowly starts to make progress
Adam had his first stem-cell injection in February 2004. A couple of months later, the Sussers took him to Bascom Palmer Eye Institute in Miami, where
doctors told them his optic nerve was breaking down from lack of use. There was little chance he would regain his sight.
"My wife is crying. I'm trying to keep it together," Gary said, recalling that day.
Gary was angry. He called Dr. David Steenblock, a California doctor of osteopathy who works with Ramirez. Steenblock had told Gary before the
stem-cell shot that Adam would be a good candidate for the stem-cell treatment.
"I was so P.O.'ed. I called Steenblock up. I called him snake oil," Gary said. "They said they wanted to order a test. I said, 'Don't give me this.
Don't give me excuses.' "
A few weeks later, on Memorial Day weekend, Adam's eyes followed a brightly colored soccer ball that Brandon rolled silently across the floor in their
Boca Raton home. The Sussers were ecstatic. They took Adam to an ophthalmologist at Nova Southeastern University in Davie who said that Adam had
visual activity and should get glasses.
Gary called Steenblock back. They later scheduled another stem-cell shot for November.
The Sussers have seen other progress. Adam can now take steps in his walker and has started speaking, even though he can't control when he speaks. And
his words are rare.
But some stem-cell researchers doubt that Adam's progress has anything to do with the injections.
"It's a scam," said Dr. Evan Snyder, a pediatric neurologist, stem-cell biologist and director of the stem-cell and regeneration program at the
Burnham Institute in La Jolla, Calif. "Those cells getting into circulation such that they'd be able to address chronic disorders like cerebral palsy
is beyond comprehension of how biology works."
Dr. Joanne Kurtzberg, director of pediatrics at the blood and bone marrow transplant program at Duke University Medical Center in Durham, N.C., said
the patient must be given chemotherapy to prevent the body from attacking the stem cells, and doctors must match the cells to the patient's tissue
type. She also said the cells must be given intravenously or injected into the fluid around the brain to be effective on brain damage.
"Giving them under the skin is useless,'' she said.
Both Gary and Judy acknowledge that it is hard to tease out what progress is due to the stem cells and what is due to Adam's myriad therapy sessions.
But they can't explain Adam's sight with therapy.
"Is it coincidence? Is it luck? Is it snake oil? But if it ain't broke, don't fix it. And if the risk is minimal. If he's 15 and it did just this
much," Gary says, leaning forward and holding his thumb and index finger just a hair apart, "it's worth it."
An eye on present, the other on future
In the San Diego hotel suite, Brandon hooks up a portable DVD player to the television and Gary sticks in Roy Orbison: Black and White Night. He
scrolls to Ooby Dooby and turns the volume way up. In the bedroom, Sheila has laid Adam on the bed and is changing his diaper. He smiles when he hears
the song. Next is Oh, Pretty Woman, another of Adam's favorites.
There's no sign of the van driver. The family decides to go outside and get some sun while they wait. Gary holds Adam in his arms. Brandon brings out
fat pieces of sidewalk chalk and begins drawing elaborate, tangled designs. Judy stands by.
"We talk about it. We say we hope we're doing the right thing," she says. "We get so many calls from parents all over. They have their own stories,
and they're looking for hope. We tell them we can't say it's the stem cells that do all this."
She looks down at Brandon, covered in chalk dust.
"I would do the same for him, God forbid," she says.
Adam smiles as Gary horses around with him, flipping him over and holding him by his ankles so that his brown hair hangs straight down. He's a skinny
35 pounds, but soon it won't be so easy to carry him into the bedroom and the shower. He needs help to do everything. At 51, Gary is an older father
with one eye on the future.
Family takes treatment in stride
The whole procedure takes the Mexican doctor less than an hour. Ramirez had decided against the IV method, saying Adam wasn't ready.
Judy consoles Adam after the shot, holding him in her lap.
"Mommy's going to take you for a walk. Want to go for a walk?" she says to her son. Adam continues to cry but less violently.
"Some children are more sensitive than others," Ramirez says.
"He's a tough kid, really tough," Judy says.
"You're a tough lady," Ramirez says to her. She smiles a little and shakes her head.
The van is back on the road with DerAlexanian behind the wheel and Adam in Gary's lap, his tears gone. The van joins the three long lanes of cars at a
standstill, waiting to cross the border back into the United States.
"I'm always a skeptic. I'm always half-optimistic," Gary says.
"The first time, I thought it was water,'' he said of the vial of stem cells. "I thought it was B.S."
"If that's true, it's a sin to do that," Judy says.
Outside the van's tinted windows, vendors are weaving through the cars, hawking soccer jerseys, glass vases, fried dough, stuffed toys, crucifixes,
mangos, limes, a print of the late Pope John Paul II bowing to the Virgin Mary.
Gary talks to DerAlexanian about a family from Broward County coming down for their first stem-cell treatment later this week. Their daughter is in
therapy with Adam, and they learned about the Mexican clinic from the Sussers.
Gary says he doesn't know when he'll bring Adam for another injection.
Soon Adam is smiling. The only remnant of the shot is the small round Band-Aid on his belly.
"If that's the worst of the shot, what is there versus the gain?" Gary asks.
Photo by Gary Coronado
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Many skeptical of stem-cell therapy
http://www.palmbeachpost.com/health/content/local_news/epape...
By Stephanie Horvath
June 19, 2005
TIJUANA, Mexico ? Gary and Judy Susser of Boca Raton believe injections of umbilical-cord stem cells by a doctor in Mexico are helping heal their
quadriplegic son, Adam, but several U.S. stem-cell researchers cast doubt on the treatment.
The researchers say the procedure, which hasn't been approved by the Food and Drug Administration and can't be performed in the United States, is
unsupported by research. Others call it an outright scam.
"It sounds like snake oil," said Dr. Evan Snyder, a stem-cell biologist and director of the stem-cell and regeneration program at the Burnham
Institute in La Jolla, Calif.
Dr. Fernando Ramirez del Rio, the Tijuana doctor who treats Adam, said doubters simply haven't seen the stem cells in action.
"They have not been exposed to the work. The doctors that have been here, they see the results so they get convinced," he said.
Ramirez and Dr. David Steenblock ? a California osteopathic physician who is following the progress of people who get stem-cell treatments abroad,
including 4-year-old Adam ? say they don't have the money, university support or time to do the lengthy clinical trials required to get FDA approval.
And patients need help now.
"When I see people suffering and all the treatments I can bring to them in this country aren't enough, I tend to look elsewhere," Steenblock said.
"It's a moral issue. Do you as a physician do everything to help your patient? Or only do what the FDA allows?"
Stem-cell research hot political topic
A year ago, Adam Susser was a blind quadriplegic with cerebral palsy. Now he has some vision, takes steps with a walker and sometimes speaks. His
parents think the progress is due to both therapy and the stem-cell injections from Ramirez. Each shot costs Adam's parents $6,000.
Stem-cell research has been the subject of heated political debate in Washington. The House of Representatives passed a bill last month that would
allow federal dollars to fund embryonic stem-cell research that uses unused embryos stored in fertility clinics; the Senate is being encouraged to
vote on a similar bill. President Bush has promised to veto any bill, saying the research destroys human life.
Even if the legislation passes, it would not directly help Adam because the stem-cell injections aren't approved by the FDA.
The lack of strong government support for stem-cell research has sent patients abroad, said Dr. Camillo Ricordi, director of the University of Miami's
Diabetes Research Institute, which conducts both umbilical-cord and embryonic stem-cell research. "The whole field of stem-cell research in the United
States has been hampered," he said. "That's why you're seeing groups in other countries coming up with this."
Doctors lack resources for clinic trials
Steenblock runs the nonprofit Steenblock Research Institute in San Clemente, Calif. On its Web site, it promotes umbilical-cord stem-cell therapy for
everything from leukemia to multiple sclerosis to diabetes. Steenblock said that if patients ask, his institute will give them the names of foreign
doctors who perform stem-cell treatments, including Ramirez's.
Steenblock is studying about 100 patients receiving stem-cell treatments abroad and said most of the data are self-reported.
In 1994, Steenblock, who has a medical practice in Mission Viejo, Calif., was fined $10,000 and placed on five years probation by the California Board
of Osteopathic Examiners after being found guilty of negligence and incompetency in connection with two patients, one of whom died.
Steenblock said there was fraud on the part of the state examining board, but he decided not to sue.
"I believed it was best to take my lumps and move on," he said.
Both Ramirez and Steenblock said they would like to do a clinical trial for FDA approval but they lack the resources. The FDA regulates stem-cell use
as it does drugs, so any stem-cell treatments must receive approval.
Neither doctor has conducted a scientific study of the procedure for publication or tested it on animals, though Steenblock said he has a paper on
umbilical-cord stem cells and cerebral palsy under peer review by the journal Neuroscience Letters.
"I'm all for going through the FDA. You give me some money and I'll go through the FDA," Steenblock said, but he added: "Why should you go through it
when you could send the patient to Mexico or Costa Rica rather than deal with the malarkey here? The amount of red tape is astronomical."
But the Burnham Institute's Snyder said legitimate treatments have little trouble gaining FDA approval.
"If you have really compelling data, it doesn't take too long to go through the FDA," he said. "Those who want to bypass that, they can make up any
justification they want."
Authenticity of stem cells questioned
Sitting in his Tijuana office, Ramirez said patients come from around the world and usually have spinal-cord injuries or brain damage.
"We've seen marvelous things like children who since birth have been on a breathing machine are taken off. Children who couldn't see can see. People
who were paralyzed start walking," he said. "In this year we had two people start speaking."
Ramirez, who said he received his medical degree from Mexico's National Autonomous University in 1966 and trained at several American and British
hospitals, said he began doing stem-cell treatments in Tijuana in 1989. He began with injecting shark stem cells into the spines of paralysis
patients.
Ramirez said he buys his stem cells from a U.S. distributor that purchases them from the United States and Germany. He couldn't remember the name of
the company. It's legal to buy and sell stem cells in the U.S. The stem cells he used in Adam's June 6 injection were brought over the border with the
Sussers, frozen and carried in a small cooler. Thawed, the liquid in the vial appeared to be perfectly clear.
U.S. stem cell researchers, none of whom have seen Ramirez perform an injection, are skeptical.
If the vial contained stem cells, the liquid should have looked opaque and milky, said Ricordi, of the University of Miami. He also said the tissue
just under the skin is a poor area for circulation.
Ricordi offered to test a vial of Ramirez's stem cells in his lab for The Palm Beach Post to prove whether they were stem cells. Ramirez didn't return
repeated calls. Steenblock refused the offer.
"What do we care what you think? We know it's real," Steenblock said. "This stuff is not made up. Do you think we're sitting around here making up
facts?"
Dr. Joanne Kurtzberg, director of pediatrics at the blood and marrow transplant program at Duke University Medical Center in Durham, N.C., also said
that stem cells appear opaque in a vial. She performs umbilical-cord blood transplants in children with leukemia and genetic disorders.
"It's a total sham, the whole thing," Kurtzberg said of Ramirez's procedure. Kurtzberg said the cells must be given intravenously or injected into the
fluid around the brain to be effective on brain damage.
"Giving them under the skin is useless," she said.
Sussers: Adam's gains not a coincidence
The Sussers have heard all the arguments and talked to many of the stem-cell experts. Gary Susser said he's offered Adam for clinical studies in the
United States, but no one is doing stem-cell research with cerebral palsy. They know the injections could be a scam.
Both Snyder and Kurtzberg doubt the cells had anything to do with Adam's newfound sight. Snyder said children with cerebral palsy sometimes have
blindness that can spontaneously change over time.
"No one can explain to me why my son's vision clicked," Gary said. "His improvements are too coincidental. His gains are too much."
The Sussers feel they owe it to Adam to keep getting him stem-cell injections.
"What would you do?" said Judy, Adam's mother. "If I don't do it, I'll feel guilty. Something helps him right after the stem cells. If he's improving,
why stop doing it?"
Photo by Gary Coronado.
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