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May 19, 2015

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ByKirstenGrieshaber TheAssociatedPress BERLIN TheEbolacrisisin western Africa showed the world in a painful way that a global catastrophe plan is needed to deal with future epidemics, German Chan- cellor Angela Merkel said Monday. "The struggle (against Ebola) is only won if there are no new cases and if we have learned the les- sons from this crisis: we should have reacted ear- lier," Merkel told the 68th World Health Assembly in Geneva. The World Health Or- ganization has been criti- cized for its slow response to early warnings about the Ebola outbreak. More than 11,000 people have died in the outbreak since the first cases became public in rural Guinea in March 2014. Merkel said that WHO structures need to become more efficient, suggesting that the organization has to become more central- ized. An independent panel of experts is currently look- ing into the WHO's slow response to early warnings about the Ebola outbreak. The panel said last week in its first report that "deep and substantial" change is needed at the World Health Organization. After studying what went wrong in the WHO's re- sponse to the Ebola crisis, the panel said it's still not clear why the global body took so long to heed warn- ings. Looking forward, the chancellor said Ger- many would give 200 million euros ($228 mil- lion) to help developing countries build up bet- ter-functioning health care systems — which she said was essential to deal with future ep- idemic outbreaks. She said 70 million euros of this would go specif- ically to the Ebola-ridden countries in western Af- rica. "If we react faster, and act faster, we will manage to better prevent a crisis like Ebola the next time," Merkel told the assembly, which is the WHO's decision-making body. It is attended by dele- gations of all WHO member states and meets annually in Geneva, Switzerland. Ebola continues to spread in Guinea and Si- erra Leone, while Liberia was declared Ebola-free earlier this month. EBOLA Me rk el : Gl ob al c at as tr op he p la n ne ed ed a e r cr is is THEASSOCIATEDPRESS German Chancellor Angela Merkel speaks during the opening of the 68th World Health Assembly at the European headquarters of the United Nations in Geneva, Switzerland. By Matthew Perrone The Associated Press BEVERLY HILLS The liquid is dark red, a mixture of fat and blood, and Dr. Mark Berman pumps it out of the patient's backside. He treats it with a chemical, runs it through a processor — and injects it into the woman's aching knees and elbows. The "soup," he says, is rich in shape-shifting stem cells — magic bullets that, according to some doctors, can be used to treat every- thing from Parkinson's dis- ease to asthma to this pa- tient's chronic osteoarthri- tis. "I don't even know what's in the soup," says Berman. "Most of the time, if stem cells are in the soup, then the patient's got a good chance of getting better." It's quackery, critics say. But it's also a mushroom- ing business — and almost wholly unregulated. The number of stem-cell clinics across the United States has surged from a handful in 2010 to more than 170 today, according to figures compiled by The As- sociated Press. Many of the clinics are linked in large, for-profit chains. New busi- nesses continue to open; doctors looking to get into the field need only take a weekend seminar offered by a training company. Berman, a Beverly Hills plastic surgeon, is co-founder of the largest chain, the Cell Surgical Net- work. Like most doctors in the field, he has no formal background in stem cell re- search. His company offers stem cell procedures for more than 30 diseases and conditions, including Lou Gehrig's disease, multiple sclerosis, lupus and erec- tile dysfunction. There are clinics that market "anti-aging" treat- ments; others specialize in "stem-cell facelifts" and other cosmetic procedures. The cost is high, ranging from $5,000 to $20,000. Berman and others point to anecdotal accounts of seemingly miraculous re- coveries. But while stem cells from bone marrow have become an estab- lished therapy for a hand- ful of blood cancers — and while there are high hopes that the cells will someday lead to other major medical advances — critics say en- trepreneurs are treating pa- tients with little or no evi- dence that what they do is effective. Or even safe. They point to one stem-cell doctor who has had two patients die under his care. "It's sort of this 21st cen- tury cutting-edge technol- ogy," says Dr. Paul Knoep- fler, a stem cell researcher at the University of Califor- nia at Davis. "But the way it's being implemented at these clinics and how it's regulated is more like the 19th century. It's a Wild West." 'Liquidgold' Doctors in South Korea and Japan pioneered the fat-based stem cell tech- nique, using it to suppos- edly enhance face lifts and breast augmentation. For years, U.S. patients would travel to hospitals in Asia, Latin America and Eastern Europe — places where reg- ulation is more lax than in the United States — to have these procedures as part of the international "stem cell tourism" trade. Plastic surgeons in the U.S. quickly realized the fi- nancial potential of the fat they were already taking out of patients' bellies and backsides through liposuc- tion — something that had been disposed of previ- ously. Berman calls it "liq- uid gold." Some early adopters have expanded into chains, of- fering doctors across the country a chance to join the franchise after buying some equipment and attending a seminar. These doctors sometimes appear on local TV news broadcasts, drum- ming up new business from patients and stoking inter- est from other doctors. One national chain mar- kets itself online with ac- counts of celebrity athletes who have been treated with its stem cell procedures. Prospective patients are then directed to a call cen- ter, where sales represen- tatives try to match them with stem cell doctors over the phone. Berman spent over 30 years as a Beverly Hills cosmetic surgeon before co-founding the Cell Sur- gical Network in 2012. He and his business partner, a urologist, adapted equip- ment and techniques from Asia into a liposuction- based procedure. Today, the Cell Surgi- cal Network is the largest stem cell chain in the na- tion, with 67 locations and a roster of more than 100 doctors in 22 states. Doc- tors who join the network generally charge about $9,000 per procedure; they pay Berman and his part- ner $25,000 to $30,000 for a South Korean cell-sepa- rating machine and other equipment. Stem cells have long been recognized for their ability to reproduce and transform into other cell types. Be- cause of their ability to re- pair and replace tissue, they are thought to hold poten- tial for treating many dis- eases and injuries. Embryonic stem cells are the most versatile because they have the ability to form all the various cell types in the body, but their use in medicine is considered con- troversial by some because it involves the destruction of human embryos. Adult stem cells are less versatile, but can be easily harvested from various tis- sues in the body, including bone marrow and fat. For decades, they have been routinely transplanted, first in bone marrow trans- plants and then in proce- dures that transfer the cells alone. They have been use- ful in combatting leukemia, lymphoma and other blood diseases, saving the lives of tens of thousands of people each year. The stem cell clinics, though, promise results far beyond those currently con- sidered prudent by main- stream medicine. "I think responsible pro- fessionals have a broad con- sensus that marketing of these unproven interven- tions is premature and un- professional, if not unethi- cal," says Dr. George Daley, a founding executive of the Harvard Stem Cell Insti- tute and professor at Har- vard Medical School Julia Matsumoto, of Fountain Valley, claims stem cell injections have helped maintain her eye- sight four years after being diagnosed with chronic re- lapsing neuropathy, which causes inflammation of the optic nerves and can lead to blindness. Berman has treated her on a monthly basis since 2012, free of charge, be- cause Matsumoto cannot afford repeat procedures. Berman liposuctions fat from her abdomen then processes it with a spinning centrifuge machine and a drug, before filtering it and infusing the mixture into an injection site in Matsu- moto's chest. "Things were so vivid and bright literally 30 min- utes after the stem cells were given to me," Matsu- moto says, recalling her first treatment. "I started crying on the way home." Such patient anecdotes are not considered reliable medical evidence. And be- cause stem cell clinics have not published large, rigor- ous studies of their tech- niques, it's virtually impos- sible to evaluate their re- cord of success. Berman calls his busi- ness model "patient- funded research," and says he plans to soon publish the results of a 1,000-pa- tient study demonstrating its safety. Cell Surgical has hired consultants to follow up with patients over the phone and survey how they are feeling. But Leigh Turner, a pro- fessor of bioethics at the University of Minnesota, says charging patients to participate in medical re- search is bizarre and uneth- ical. He calls the approach "unauthorized, for-profit human experimentation," and has asked the Food and Drug Administration to in- vestigate Berman, arguing that his business amounts to selling unapproved, ex- perimental drugs. Some practitioners point to early-stage laboratory and animal studies which have been published in sci- entific journals. But aca- demics say such findings cannot be applied to hu- mans and don't provide critical information about potential side effects like in- fections, tumors and blood clots. "This field, sadly, is con- taminated by lots of poor- quality data that people are using to move forward and actually treat patients," says Daley, of Harvard Medical School. The risks The clinics insist that their treatments are safe, but routinely require that patients sign waivers. Cell Surgical's patients sign an informed consent form acknowledging that they are participating in an experimental study. The form states that there is no guarantee that the stem cell treatment will work, and lists potential risks. It also makes clear that patients are responsible for paying the full cost of the proce- dure, which is not covered by insurance. Patients of Dr. Zannos Grekos, a cardiologist in Bonita Springs, Florida, who specialized in using stem cells to treat debili- tating diseases, also were required to sign a consent form, acknowledging the procedures' risks, includ- ing death. But families of at least two of Grekos' patients say he downplayed the risks. Gina Adams, daughter of patient Richard Poling, says her family was told her fa- ther would be "back on the golf course the next day" af- ter a routine procedure he hoped would help him re- cover from a lung condition that made breathing diffi- cult. The cost was $8,000. The family was told that the stem cells would regen- erate Poling's lung cells. CLINICS Stem cell 'Wild West' takes root amid lack of US regulation THE ASSOCIATED PRESS Dr. Mark Berman, of the Cell Surgical Network, collects fat from a patient's back as part of an experimental stem cell procedure in Beverly Hills. 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