The Stem Cell Tissue Profiteers
How well-meaning donations end up fueling an unproven, virtually unregulated $2 billion stem cell industry.
 
Their shoulders and backs and knees were giving out. Pills and steroid injections hadn’t eased their pain. They were scared of surgery. So, one afternoon last October, two dozen men and women, many of them white-haired, some leaning on canes, shuffled into a meeting room at Robson Ranch, a luxury retirement community in Denton, Texas. Sipping iced tea and clutching brochures that promised a pain-free tomorrow, they checked off their ailments on a questionnaire.
 
They were there to see a presentation by Dr. David Greene, who was introduced as a “retired orthopedic surgeon.” Atlas Medical Center, a local clinic that specializes in pain treatment, hosted the event. Greene, a short, trim man with his hair slicked up, ignored the stage and microphone and stood close to his audience. After warming up the crowd with a joke about his inept golf skills, Greene launched into his sales pitch. A tiny vial no larger than the palm of his hand, he told the group, contains roughly 10 million live stem cells, harvested from the placenta, amniotic fluid, umbilical cord or amnion, the membrane that surrounds the fetus in the womb.
 
Injected into a joint or spine, or delivered intravenously into the bloodstream, Greene told his listeners, those cells could ease whatever ailed them.
 
On a screen behind him, Greene displayed a densely printed slide with a “small list” of conditions his stem cell product could treat: arthritis, tendinitis, psoriasis, lupus, hair loss, facial wrinkles, scarring, erectile dysfunction, heart failure, cardiomyopathy, chronic obstructive pulmonary disease, asthma, emphysema, stroke, Alzheimer’s disease, multiple sclerosis, ALS, neuropathy, pelvic pain, diabetes, dry eye, macular degeneration, kidney failure. And that was just a sample. “I need to add a couple more slides,” Greene said with a laugh.
 
Greene said that amniotic stem cells derive their healing power from an ability to develop into any kind of tissue, but he failed to mention that mainstream science does not support his claims. He also did not disclose that he lost his license to practice medicine in 2009, after surgeries he botched resulted in several deaths. Instead, he offered glowing statistics: amniotic stem cells could help the heart beat better, “on average by 20%,” he said. “Over 85% of patients benefit exceptionally from the treatment.”
 
“Patients come back to the center saying, ‘I can walk farther, I can breathe easier, I can sleep better,’ ” he proclaimed. “It’s remarkable the outcomes we’ve been seeing for the last few years.”
 
In the second row, a slender woman in a striped jacket, who had hobbled into the meeting on a wooden cane, pumped her fists in the air. “Stem cells!” she cheered.
 
For more than half a century, the regenerative possibilities of stem cells — which the body stores to repair damaged tissue and organs and restore blood supply — have tantalized the medical community. Bone marrow transplants for cancer patients, which rely on blood stem cells, fulfill this potential. But alongside legitimate, scientifically proven treatments, an industry has sprung up in which specialized clinics offer miracle remedies from poorly understood stem cell products.
 
These clinics are multiplying in the United States. According to a tally by Leigh Turner, an associate professor of bioethics at the University of Minnesota, there were 12 such clinics advertising to consumers in 2009; in 2017, there were more than 700. Unproven cellular therapies are a $2 billion global business, according to a recent paper co-authored by Massimo Dominici, the lead investigator at the cellular therapy lab at the University of Modena and Reggio Emilia, in Italy.
 
This burgeoning business is largely unregulated. Technically, manufacturers are required to submit stem cell therapies for review as a drug, and to provide evidence of their safety and efficacy, but the U.S. Food and Drug Administration hasn’t enforced the rule consistently. The former FDA commissioner Dr. Scott Gottlieb acknowledged in an interview that the agency’s laissez-faire attitude has made it easier for stem cell clinics to proliferate. “This is an example where the FDA, for a long period of time, took enforcement discretion, then the field grew,” he said. “Then it becomes hard to step in and actually apply the regulation.”
 
Many clinics offer stem cells taken from a patient’s own bone marrow or fat. But they’re being challenged by…Continue Reading
 
This article is a collaboration between ProPublica and The New Yorker.
 
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    Spending Just 20 Minutes with Nature Will Reduce Stress, Says Study
    Instead of sitting at your desk, a lunchtime stroll through a park is one of the most effective stress-lowering treatments that a doctor can prescribe, new research suggests.
     
    This research was conducted by a team of scientists led by Dr Mary Carol Hunter, an associate professor at the University of Michigan, and has been published in the scientific journal Frontiers in Psychology. Communing with nature has long been recognised as restorative but now scientists claim to have worked out the optimum daily dose. 
     
    “We know that spending time in nature reduces stress, but until now it was unclear how much is enough, how often to do it, or even what kind of nature experience will benefit us,” says Dr Hunter. “Our study shows that for the greatest payoff, in terms of efficiently lowering levels of the stress hormone cortisol, you should spend 20 to 30 minutes sitting or walking in a place that provides you with a sense of nature.”
     
    The results from the study indicate that spending 20 to 30 minutes in surroundings that made a person feel connected to nature, lowers stress hormones by about 10%, enough to improve their feeling of well-being. ‘Nature pills’, as the experience is often referred to by healthcare practitioners, could be a low-cost solution to reduce the negative health impacts stemming from growing urbanisation and indoor lifestyles dominated by screen viewing. In order to assist healthcare practitioners looking for evidence-based guidelines on what exactly to dispense, Dr Hunter and her colleagues designated an experiment that would give a realistic estimate of an effective dose. 
     
    For the study, participants were asked to take a ‘nature pill’ over an eight-week period, for a duration of 10 minutes or more, at least three times a week. To track the effects of this dose, levels of cortisol were measured from saliva samples taken before and after the prescribed nature experience, once every two weeks.  
     
    “Participants were free to choose the time of day, duration and the place of their nature experience, which was defined as anywhere outside that in the opinion of the participant, made them feel like they’ve interacted with nature,” Dr Hunter explained. She further added, that there were a few additional constraints to minimise factors known to influence stress such as taking the nature pill in daylight hours, no aerobic exercise and avoiding use of social media, Internet, phone calls, conversations and reading.
     
    This particular experiment allowed participants to make allowances for their busy lifestyles by providing them with the freedom to choose an appropriate time slot for their nature experience. This novel experimental design also allowed researchers to gather meaningful results. “Building personal flexibility into the experiment allowed us to identify the optimal duration of a nature pill, no matter when or where it is taken and under the normal circumstances of modern life, with its unpredictability and hectic scheduling,” said Dr Hunter.
     
    The study accommodated for day-to-day differences in a participant’s stress status by collecting four snapshots of cortisol change affected by the prescribed nature experience. It also allowed researchers to identify and account for the impact of ongoing, natural drop in cortisol level as the day progresses, making the estimate of effective duration more reliable. 
     
    The collected data revealed that just a 20-minute nature experience was enough to significantly reduce cortisol levels. But if you were to spend a little more time immersed in a nature experience, i.e., 20 to 30 minutes sitting or walking, cortisol levels dropped at their highest rate. After that, additional de-stressing benefits continue to add up, but at a slower rate. 
     
    “Healthcare practitioners can use our results as an evidence-based rule to thumb on what to put in a nature pill prescription,” says Dr Hunter. “It provides the first estimates of how nature experiences impact stress levels in the context of normal daily life. It breaks new ground by addressing some of the complexities of measuring an effective nature dose.”
     
    Dr Hunter and her colleagues hope that this study will form the basis of further research in this area. They are hoping that their experimental approach can be used as a tool to assess how age, gender, seasonality, physical ability and culture can influence the effectiveness of nature experiences on well-being. Dr Hunter believes that this will allow for customised nature pill prescriptions, as well as a deeper insight on how to design cities and well-being programmes for the public.
     
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    Better To Get Nutrients from Food Rather than Supplements, Says Study
    Insufficient consumption of fruits and vegetables is a well-known dietary problem today; many try to make up for it by taking supplements. Dietary supplements are being consumed under the belief that they are an easy way to get the essential nutrients for our body. However, new research has suggested that vitamins and supplements may not be enough to keep you healthy.
     
    This study has been conducted by a research team from Tufts School of Medicine (USA) and published in the scientific journal Annals of Internal Medicine. The study reports that sufficient intake of certain nutrients from food is linked to a lower risk of cancer and all-cause mortality. Conversely, nutrients from supplements are not associated with a reduced risk of death; in fact, some supplements may actually increase mortality risk. 
     
    According to the research, the problematic supplements were specifically calcium and vitamin D. Doses of calcium that exceeded 1,000mg (milligrams) per day were tied to a high risk of death from cancer. Similarly, vitamin D supplements, taken by people who do not have vitamin D deficiency, were connected to an elevated likelihood of death from all causes, including cancer. 
     
    “As potential benefits and harms of supplement use continue to be studied, some studies have found associations between excess nutrient intake and adverse outcomes, including increased risk of certain cancers,” said lead author Prof Fang Fang Zhang, from Friedman School of Nutrition Science and Policy at Tufts University. “It is important understand the role that the nutrient and its source might play in health outcomes, particularly if the effect might not be beneficial.”
     
    The research was conducted using data from 27,000 US adults aged 20 years and older to explore two relationships—whether adequate or excess nutrient intake was linked to all-cause mortality; and whether results changed if the nutrients came from supplements instead of food. For each nutrient, scientists calculated the daily supplement dose by combining the frequency with the product information for each ingredient, the amount of the said ingredient per serving and its unit. The assessment was based on participants’ dietary intake of nutrients from food using 24-hour dietary recalls and mortality outcomes through the National Death Index through 31 December 2001. 
     
    The phase of the study that examined the impact of nutrients on death risk revealed three associations, viz., sufficient intake of magnesium and vitamin K were linked to a lower risk of death; sufficient intake of vitamin K, vitamin A and zinc were tied to a lower cardiovascular disease risk of death; and excess calcium intake was connected to a higher likelihood of death by cancer. When nutrients from food were compared to nutrients from supplements, the results showed the first two associations were due to nutrients from food rather than nutrients from supplements. While no adverse effect of calcium intake from food was noted, excess calcium intake from supplements was linked to an increased risk of death from cancer. In addition, supplements had no effect on the risk of death in people with low nutrient intake from food. 
     
    “Our results support the idea that, while supplement use contributes to an increased level of total nutrient intake, there are beneficial associations with nutrients from foods that aren’t seen with supplements,” Prof Zhang said. “This study also confirms the importance of identifying the nutrient source when evaluating mortality outcomes.” She further added that it is important to understand the effect that a nutrient and its source might play on health and mortality outcomes, especially when it is not beneficial. 
     
    The research team has noted some limitations of the study, including the duration for which use of dietary supplement was studied. The team are also aware that, since the prevalence and dosage of dietary supplement was self-reported, there is certainly a possibility of recall bias. The authors believe that this study has only pointed out a possible cause and further research on this possible connection will be necessary.
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