By Terrence McCoy
By Scott Fishman
By Deirdra Funcheon
By Allie Conti
By New Times Staff
By Ryan Pfeffer
By Deirdra Funcheon
By Kyle Swenson
Under bright white lights, several pairs of hands reach into a gaping red gash in the very pregnant belly of Rosa Simmons. With a squelch, her seven-pound daughter Emily, gray and wriggling, appears.
It is June 6 at Northwest Medical Center in Margate. Rosa Simmons' cesarean section has been swift and uneventful except for the presence of a camera crew. But the crew isn't here to film Emily's birth.
Now that the delivery is over, the real show can begin.
"We are going to demonstrate how we obtain umbilical cord blood," says Dr. Bruce Zafran, Rosa's Coral Springs gynecologist. He is speaking to a live audience watching via webcast, linked through the St. Petersburg offices of a company called Cryo-Cell.
"This is a very simple procedure," Zafran narrates as the camera zooms in on the greenish umbilical cord, which is resting, surrounded by crimson puddles of blood, on Rosa's abdomen.
As the camera rolls, a nurse presses the sharp tip of a long needle against the ridged skin of the umbilical cord. It pierces the surface, and dark-red blood wells up through clear tubing to drip into a clear plastic bag.
"We will try to drain approximately 100 to 150 cc's of cord blood to save the umbilical cord blood stem cells," Zafran says as the bag slowly fills with the dark maroon liquid. "We should have a very good specimen collection to send to Cryo-Cell."
Cryo-Cell, which preserves and stores umbilical cord blood, has paid Zafran to arrange this demonstration. Most umbilical cords are discarded as medical waste after birth. But Cryo-Cell encourages parents to "bank" the stem cells that are found in cord blood for use in future years.
There's good reason to save cord blood: It can be used in lifesaving transfusions to cure a variety of diseases such as lymphoma and leukemia. Painless to collect, cord blood has become a convenient alternative to bone marrow, which also contains blood-producing stem cells.
Cryo-Cell urges parents to store cord blood so that if a child later develops an illness, the child's own blood is a match, of course, and can be used if a transplant or transfusion is needed. The blood may also be a match for siblings or other family members.
But for years, experts have warned that the chances of a family ever benefiting from the stored cord blood of its own children are slim to none. When a child uses its own cord blood, it is referred to as an "autologous" transfusion. But autologous transfusions can't treat most diseases, and the chances of a match for a sibling is 1-in-4.
Both the American Medical Association and the American College of Obstetricians and Gynecologists discourage new parents from banking cord blood privately and encourage them instead to donate to the growing national network of public banks, where cord blood may be used to save someone else's life.
But that disapproval hasn't stemmed the popularity of private banking. In fact, business is booming Cryo-Cell, one of the top three private cord blood banks in the country, has more than 100,000 units of cord blood stored in its Oldsmar facility. For families convinced, despite evidence to the contrary, that their child may benefit from its own stored blood, the price may seem reasonable: $1,500, plus a yearly $100 storage fee for as long as a family is willing to pay.
For ethical reasons, however, it's a doctor's job to explain to patients that private cord blood banking is a slim hope at best. But working against those ethics is another persuasive force: Obstetrician-gynecologists are under heavy pressure from private cord blood banks themselves, which employ incentives and advertising to convince doctor and patient alike that cord blood banking is, despite the odds, a smart choice.
Bruce Zafran, Rosa Simmons' ob-gyn, is on Cryo-Cell's payroll as a consultant and acts as the company's spokesman. With his participation in the webcast of the birth of Emily Simmons, he has also become an advertiser. Although he insists that he remains objective, Zafran's relationship with Cryo-Cell illustrates how the private cord blood industry is paying doctors to keep a problematic and largely useless service alive and profitable.
Two months after Emily's birth, Matthew and Rosa Simmons' cramped condo in Margate is womblike in cool semi-darkness, lit only by the television and the warm flickering of several candles placed on the coffee table in anticipation of a reporter's arrival.
The young Latino couple has been through this routine before. Following the webcast of Emily's birth, they were abruptly thrust into the spotlight when several newspapers, including the South Florida Sun-Sentinel, interviewed them about the promise of Cryo-Cell.
Both parents work long hours at the nearby Northwest Medical Center, Matthew as a cook and Rosa as a sterilization specialist. Both are employed, in effect, by Zafran, who is chairman of the board at Northwest Medical Center. Rosa chose Zafran as her ob-gyn because she saw him every day on the job. She now considers him a personal friend and laughs about how he insists on speaking to in her native Spanish.
With one eye on her sleeping baby, Rosa talks about cord blood. "It was just because you never know," she says. "Yeah, you have life insurance, you can have health insurance, but if something happens, then at least we have this."
As Rosa understands it, cord blood will safeguard Emily against many diseases. "When I read about the cord blood, I understood that the cord takes care of some kinds of disease. They've done about 70 diseases."
Yet, neither Rosa nor Matt has spoken to anyone from Cryo-Cell. They say they get their knowledge of the benefits of banking cord blood from their doctor, Zafran. James and Sandra Rosenberg, a young family in Deerfield Beach, are two more of Zafran's patients. They've decided to bank their first child's cord blood with Cryo-Cell, even though Zafran told them that the chance they'll use the blood is small.
"We've been trying for so long to have a child of our own," James says. "We're blessed right now by having this child, so if anything was ever going to happen... They say cancer, leukemia; they say the cells would help. We've been waiting for so long and trying for so long that I do not think that you could really put a price tag on your child right now. We're going to take every precaution we can." Though Zafran educates patients about the slim odds of using privately banked cord blood, both the Simmons and Rosenberg families told New Timesthat, contrary to that point of view, their banked cord blood could someday save their children. Advertised as a "perfect match," that's actually the very reason cord blood is useless to the donor the blood can include the very diseased cells that may be afflicting the child.
"It's kind of like a transplant of an organ," says Kenneth Worth, a California lawyer who filed suit against a private cord blood company after considering the procedure for his own son. "It doesn't do any good to get your own bad heart or kidney back."
Even Gerald Maass, Cryo-Cell's executive vice president, cautions that "in general, it's not the best choice for someone to receive their own stem cells."
Zafran says the same thing. "It's really not for this child it's for the sibling."
Maass says that Cryo-Cell makes it clear to its customers that they are banking on the possibility of future medical advances, not current science.
"Banking your cord blood is about hoping that your child doesn't get leukemia," Maass says. "The whole procedure is a bit of a safeguard. What parents who participate in our service are doing is they're taking the opportunity to collect the cells when their baby is born that in five or ten years might provide some therapeutic values."
In late 2002, Tracey Dones' 4-month-old son, Anthony, hovered near death in Schneider Children's Hospital in Long Island. The Dones family had banked Anthony's cord blood with Cryo-Cell when he was born in July, hoping, like most parents who use the service, to provide their son with a ready supply of stem cells should he ever need a transplant. Four months later, Anthony had been diagnosed with the rare genetic disease osteopetrosis, an inherited malady that affects bone growth and can cause blindness, paralysis, and death.
Today, thanks to umbilical cord blood, Anthony is a blind but otherwise healthy 4-year-old child whose disease is considered cured. His story has been told widely as an example of the miraculous hope of cord blood banking, and his mother's testimony before Congress was integral to the passage of a bill funding public banking.
But the bag of blood from Anthony's own umbilical cord is still sitting in a freezer in Florida, unused.
Weeks before Anthony's life-saving 2002 transplant of publicly banked cord blood from the New York Blood Center, Tracey Dones called Cryo-Cell and spoke with a nurse, informing her that doctors said that Anthony's cord blood was worthless to him because it contained the same genetic deformity that caused his disease in the first place.
Dones says that the nurse didn't sound surprised but instead told her that another Cryo-Cell customer had just been diagnosed with a genetic disorder, Diamand-Blackfan anemia. That family couldn't use its stored blood from Cryo-Cell to treat its child's illness either.
Cryo-Cell currently lists both osteopetrosis and Diamand-Blackfan anemia on its website as examples of diseases that have been treated with cord blood. In small print, the company offers a caveat: "autologous (self) stem cells may not be useful in the treatment of certain above diseases."
Dones says today that she still wonders what Cryo-Cell believes it's selling people. "I'm sitting there like, 'Why are you in business? What are you storing cord blood for if people like us can't use it?'
"All this time, I was like, 'This can't be right what they're doing.' I want to know how many times people have called them up and said, 'My child is sick; I need my child's unit,' and how many units were shipped out. I'm going to tell you right now none."
Cryo-Cell disagrees. On its website, the company says that 14 times, it has had "successful cord blood transplants for diseases."
Of those 14 cases, six involved a child using its own blood and the other eight involved siblings or other close relatives. Two cases involved severe cases of diabetes.
But Cryo-Cell's definition of "success" is surprisingly narrow: This means simply that the blood the company stored was thawed effectively and used.
Maass won't give an exact number of patients whose diseases have been cured by Cryo-Cell cord blood. And when asked whether any of the six children using autologous transfusions were cured by the blood transfusions, Maass says no.
"All of them are of course highly experimental and haven't been reduced to clinical participation," he says. "Did we cure diabetes with those two transplants? Not to my knowledge. Our job is to collect blood and make sure that after it's frozen, it's thawed out and administered. The only thing that we put on our website is whether the graft was viable when it was thawed."
In other words, whether they did any good once transplanted isn't Cryo-Cell's business.
On a recent Thursday afternoon, the spacious waiting room of Royal Palm OB/GYN in Coral Springs is packed with young families and expectant mothers. Toddlers doze and heavily pregnant women shift uncomfortably as crisp orderlies call out the names of patients. In the middle of the room, a basket of dog-eared pregnancy magazines is topped with a creamy-white brochure for Cryo-Cell International. On its cover, along with the liquid eyes of newborns, is the company's slogan: "Imagine. Believe. Expect. Miracles of Umbilical Cord Blood."
Plastic sleeves stuffed with Cryo-Cell brochures adorn other surfaces, including front and center at the checkout desk. It's clear that Royal Palm OB/GYN has followed Cryo-Cell's suggestion to "brand" itself a Cryo-Cell practice.
When Zafran appears, he is short, sprightly, and almost elfin, with boyish cheeks and a winning smile. He whisks into a quiet corner office, sits, and begins listing the virtues of cord blood.
"Leukemia, lymphoma, sickle cell anemia has been cured," he says. "The scientific community believes that there is significant value in umbilical cord blood for stem cells.
"The debate is who is going to store it and how you're going to store it. Is the government going to pay for this? There aren't many public banks. Right now, if you have a child and you want to donate to a public bank, there are very few."
Zafran explains that he's been involved with Cryo-Cell on a "consultant basis" for six to seven years. He came to believe in the promise of cord blood in the late 1990s, soon after his father's death from acute leukemia, when stem cell therapies were on his mind. After writing to Cryo-Cell's then-CEO, Daniel Richard, and visiting the company's facility, Cryo-Cell proposed a partnership Zafran would become a medical adviser. Zafran agreed. Since then, 300 to 400 families from Zafran's practice have stored cord blood at Cryo-Cell.
"I go each year to the American College of Obstetricians and Gynecologists' national meeting, partially for myself and partially as a spokesperson for the company," he says.
When asked if spokesperson is his official title at Cryo-Cell, Zafran looks pained.
"Well, I hate to call it that," he says. "I would say just a consultant."
Both he and Cryo-Cell didn't answer specific questions about compensation for his services. "I do get compensated... like a consultant fee," Zafran says. "I would say it's sort of a usual and customary kind of thing."
"That's company business," says Gerald Maass, the Cryo-Cell VP. "It's a traditional doctor consulting fee."
Though laws and ethics rules prohibit doctors from benefiting financially from the sale of a particular drug or procedure, companies routinely get around such strictures by giving gifts to doctor's offices, paying doctors handsome fees for attending "educational" seminars in exotic locales, and, as the New York Times has recently reported, buying just about every MD in the country a free lunch.
And because Cryo-Cell isn't a drug company, rules governing its relationships with physicians are even more porous.
"It's not illegal," says Arthur Caplan, a professor of bioethics at the University of Pennsylvania. Unlike a drug, banked cord blood isn't immediately used. "This is something you're storing for future use, so it's held to a laxer standard."
At the same time that Maass insists that Zafran's arrangement is common in the industry and aboveboard, he hints that his competitors don't have the same scruples, with some even offering doctors blatant kickbacks. Zafran and Cryo-Cell point out that Zafran is merely paid for his participation as a member of the company's Medical and Scientific Advisory Board, never for individual referrals.
And Zafran points out that when he does act as spokesman, he doesn't necessarily promote Cryo-Cell but cord blood banking in general. That was the case in 2001, when Cryo-Cell paid Zafran, along with Minnesota Viking Cris Carter, to co-chair the company's "Save the Stem Cells Campaign." Cryo-Cell flew Zafran to Minnesota to "increase public awareness about umbilical cord blood as a non-controversial, readily available source of stem cells," according to a press release. Zafran and Maass, however, seem reluctant to discuss the Save the Stem Cells campaign, saying that it wasn't successful.
New Times spoke to several doctors and ethicists who say that even indirect financial involvement in a private cord blood bank constitutes a conflict of interest. But even if these conflicts are unethical, they aren't illegal, so most doctors in private practice are policed only by themselves.
"There's always conflict of interest in things like that," says Dr. Gary Kleiner, assistant professor of clinical pediatrics at the University of Miami's Miller School of Medicine, who conducts research with umbilical cord blood. "For me, it would be against university policy. You can't be the investigator and have a financial interest."
Conflicts of interest, experts say, can make it difficult for a practitioner to provide unbiased advice about private cord blood banking to young parents.
"In this case, people need to be told that it hasn't really worked yet," says Arthur Caplan, the bioethics expert. "You need someone without a dog in the fight to recommend a problematic procedure."
When payment is involved, Caplan says, disclosure is paramount. "One is absolutely obligated to disclose the relationship with the company how much one is paid," Caplan says. "In general, it's better not to recommend procedures you have a direct financial interest in to your patients. It's kind of coercive. Anything that might create coercion, pressure, or feelings of obligation should be avoided."
Zafran's hospital, Northwest Medical Center, is required to investigate such conflicts of interest to keep its accreditation.
Also, the American Medical Association explicitly characterizes "fee splitting," when a doctor is directly paid for referring a patient to a particular product or service, as unethical.
Maass says that what Zafran does can't be considered fee splitting. "It's not like we pay him to sell our service," he says. "We pay him to be our consultant in the capacity of the medical and scientific advisory board."
But in his office at Royal Palm OB/GYN, Zafran mentions that for the recent hospital-room webcast, he was paid more than his usual consulting fee. The extra compensation, he says, was for a lot of extra work.
"We put many, many hours into this adventure," he says. "We worked long and hard."
Some of that extra work involved using his influence on the hospital board to smooth the way for Cryo-Cell's advertisement to be shot at Northwest Medical Center.
"As chairman of the board of trustees at the hospital," he says, "it allowed us to move through administrative circles, to say that this was something we wanted to get involved in."
In addition, the Simmonses say that Zafran, their boss, recruited them for the commercial.
"We didn't talk to Cryo-Cell at all we worked entirely through Zafran," Rosa says. "He was really big into it. I had heard about it, but once I started seeing Dr. Zafran, then he gave us the brochure, so we read up on it."
The couple also heard about Cryo-Cell's webcast opportunity at the Royal Palm OB/GYN child birthing class, where a nurse told them that in exchange for participation in the webcast, a family would have its cord blood stored for free.
It seemed like a good deal, Rosa says. "I was going to have a C-section anyways, so I was like, 'Well, you know, why not? I'm going to have a C-section either way, so let's just do it this way. '"
The Sunshine State has always been fertile ground for medical get-rich-quick schemes, and cord blood stem cell businesses that operate in much more questionable ways than Cryo-Cell have blossomed here for years. In 2002, a former model named Laura Brown and a slick South African named Steve van Rooyen started a cord blood company called Biomark in a condo in Miami Beach. The couple advertised that their supply of cord blood would cure a range of diseases and soon were filling orders from all over the country. Today, Biomark faces a 52-count indictment in Georgia for fraud, but the pair have fled to Europe, where they've started a company called Advanced Cell Therapeutics that treats patients with neurological conditions using cord blood, a practice that is illegal in the United States.
I learned to be wary of Florida's cord blood businesses the hard way. About the same time that Brown and van Rooyen were advertising cord blood as a cure-all, a different doctor was setting up a cord blood clinic in Atlanta stocked with blood from a private cord blood bank in Orlando. During the brief time it operated, the Institute of Cellular Medicine showed my family firsthand how easy it is to latch on to a cord blood dream.
In the spring of 2002, my father seemed to have a cold he couldn't shake. His rich voice had become rough and scratchy, but his normal workaholic schedule as a government lawyer had kept him too busy to worry much about a persistent sore throat.
Then he was diagnosed with ALS Lou Gehrig's disease. His failing voice, we were told, was the first sign of the full-body paralysis that would overtake him, whittling his limbs down to twigs and eventually freezing his lungs. Because the nerve cells controlling his throat muscles were the first to die, doctors told us he had a variation of the disease that would progress quickly.
There is no cure for ALS, a disease that causes the body's motor nerve cells to die inexplicably. As we frantically searched for information and hope, however, it became clear that stem cells would one day be the answer.
As my father began to have trouble breathing, my family made a pilgrimage to Johns Hopkins in Baltimore, the temple of cutting-edge stem cell science. The doctor who spoke with us, a man with the bedside manner of a coat rack, told us that my father would never live to see stem cell treatment.
But ALS groups and chatrooms were alive with rumors about doctors, somewhere, who were working with stem cells that could cure ALS, now. One name in particular kept appearing: Dr. Mitchell Ghen.
Ghen, an osteopath, was infusing umbilical cord blood into patients with ALS in Atlanta. Operating without permission or oversight from the FDA and without any evidence that the procedure would work, Ghen was offering the dying a stem cell miracle. The cost of the procedure was $25,000.
My parents didn't blink. Six months after my father's diagnosis, they flew down to Atlanta in January of 2003, where, over the course of several days, Dr. Ghen injected several bags of umbilical cord blood into my father's bloodstream. Now thin and silent, his voice entirely destroyed, my father sat quietly for days while the thick red liquid, collected from ten different babies by a private Florida cord blood bank called Cryobanks International, flowed into his veins.
A month later, FDA agents raided Ghen's Atlanta clinic and informed him that his operation violated federal regulations. Two months later, Cryobanks International stopped selling Ghen the cord blood, and the transfusions ceased.
My family lost track of Ghen after that. Only a month after the stem cell treatment, tests came back showing that my father's breath strength was disintegrating. His only means of communication was a keypad that slowly sounded out words in a robotic voice. One early morning in July, we awoke to find him sitting bolt-upright on the couch, his mouth hooked up to a breathing machine that made his chest continue to rise and fall, even though he was dead.
Two more of Ghen's patients had, like my father, watched their ALS follow its course unabated. The fates of the rest of the 43 patients he treated are said to have been varied, but today, three years later, there's no way to know what happened to them.
In February 2003, just about the time we realized his transfusion was ineffective, Cryo-Cell International, Florida's largest cord blood bank, opened a Mexican office in Guadalajara. Today, on the Cryo-Cell Mexico website, are several articles describing the promise of umbilical cord blood in Spanish. One article quotes an expert who says that "patients with the transplant can improve their innate capacities to heal and increase their immune response."
The doctor's name? Mitchell J. Ghen.
When I told Gerald Maass about my family's bad experience with Ghen, he didn't seem to know the name.
"You hear about people doing it in Tijuana and other places," he said. "That appears to be what attracts desperate people. 'Buyer Beware' applies to a lot of things."
Science and law have conspired in recent years to make it more difficult for operators like the Biomark duo or Mitchell Ghen to fleece the desperate. The FDA is keeping a closer watch on disreputable operators, for example. And scientists are learning that the uses of umbilical cord blood are more limited than previously believed.
Cryo-Cell, meanwhile, isn't waiting for that information to reach the masses. The company, with the help of Zafran, is now moving away from cord blood entirely. The webcast of Emily Simmons' birth in June, in fact, was the world debut of a new medical hope that Cryo-Cell expects will be even bigger than cord blood ever was: placental stem cells.
In 2005, scientists at the University of Pittsburgh discovered that some cells from the human placenta, another byproduct of birth, seem to act like embryonic stem cells. Since then, a number of companies have been racing to patent placental cell technology and corner the newest development in the stem cell market. One, a North Carolina company called Plureon, has patented something it calls "Plureon Placental stem cells" and has signed a contract giving Cryo-Cell exclusive access to collect them. Plureon scientists (the company has not made their names known) claim that they have cured diabetic mice using the cells, but the study, which will be peer-reviewed by Dr. Zafran, has yet to be published. Still, Plureon, Cryo-Cell, and Zafran planned the June webcast as the launch of an advertising campaign aimed at convincing parents to store their placentas with Cryo-Cell.
Standing near Rosa Simmons' sliced-open abdomen, Zafran narrates as several pairs of hands deliver a large red organ Rosa's placenta.
"Dr. Plunket and Kathy are going to put things back together," Zafran says to Rosa as he holds the placenta in a plastic bowl, "and I'm going to demonstrate the collection of the Plureon Placental stem cells, if I might."
With a camera following him, Zafran carries a plastic bowl to a corner of the operating room. As Emily squalls in the background, he addresses the camera.
"The placenta is a magical creation of nature," he says. "It is this area... from which we will obtain the Plureon Placental stem cells. This life-giving property, and life-preserving property, will be obtained and sent to the laboratory, and we will demonstrate that method."
The camera rolls as Zafran poises his scalpel and slices the red mass, making brownish/black blood ooze forth. As if slicing fat from a chicken breast, he carves a rough square from the mottled, veiny organ, which he places into a small circular container and covers with clear liquid.
"That really is all there is to it," Zafran says.