I recently received in the mail a small cardboard box, solidly constructed and colored a subtle metallic gray, from the future. ELYSIUM HEALTH was printed on it in white sans-serif capital letters. Inside, a smaller crisp white box, banded in blue and imprinted with a letterpress E, described its contents as “a daily health product designed to optimize and support your most critical metabolic systems,” including “DNA repair,” “Cellular detoxification,” “Energy production,” and “Protein function.” Within was an elegant pillbox containing 60 capsules. The technical language obscured an arresting truth: Basis, which I had ordered online without a prescription, paying $60 for a month’s supply, was either the most sophisticated fountain-of-youth scam ever to come to market or the first fountain-of-youth pill ever to work.
By the time I bought it, the brand had been pummeling my awareness for weeks, the ads barreling into my Facebook feed with claims of being the “world’s first cellular health product informed by genomics.” Under usual circumstances, a self-promoting nutraceutical with a dystopian name and the implied gift of life extension would be easily dismissible, akin to reiki or juicing. Basis, which first became available last year, bypassed the FDA’s screening process, and Elysium is effectively using its customers as human test subjects, sometimes reviewing their Fitbit and other health-tracking data to determine if the pill delivers on its promise — or causes unexpected problems.
But what promise! Basis and the other pills that will likely follow it in the next five to ten years are the fruits of a scientific backwater that has been working toward this moment for a quarter-century. These drugs and supplements are aimed to be a hack of the heretofore most intractable condition of human existence, the invisible countdown clock with which evolution has equipped our bodies. They just might postpone the onset of the most common afflictions of our dotage, from cancer to heart disease to diabetes to Alzheimer’s. We won’t necessarily enjoy longer maximum life spans (though that’s a possibility), but we very well might enjoy longer health spans, meaning the vital, productive chunk of our lives before degeneration kicks in.
Others who’d taken Basis before me had described effects including fingernail growth, hair growth, skin smoothness, crazy dreams, increased stamina, better sleep, and more energy. Once I began taking it, I did feel an almost jittery uptick in mojo for a few days, and I slept more soundly as well. Then those effects seemed to recede, and there were also mornings where I felt a little out of it. If these were placebo effects, they were weird ones, because they didn’t make me feel better, only different.
Still, the pill’s seduction was powerful. The potential benefit was profound. The cost seemed manageable. And any qualms I might have had about whether this was simply next-generation snake oil faded in the halo of the six Nobel Prize winners who sit on Elysium’s scientific advisory board. Most impressively, the company’s co-founder is Leonard Guarente, who heads MIT’s aging center and is one of the pioneers of aging science, a contender for the Nobel Prize should geroscience ever get a nod from the Swedish academy.
If I were going to trust anyone in a lab coat promising a magic pill to stay healthy longer, Guarente appeared a good bet. As the month’s end drew near, I was reluctant to stop taking Basis. It seemed foolish not to continue.
Until very recently, aging was just a thing that happens, a decay or breakdown, chaotic and impossibly complex, that seems to accelerate only after we’ve reached the age of reproduction. At that point, as Guarente told me over lunch in Cambridge recently, “natural selection says: ‘I don’t care anymore.’ ” But in the past few decades there have been significant advances in maximum life spans. The number of people reaching 100 has risen and continues to rise. The record officially belongs to Jeanne Calment, who as a child sold colored pencils to Vincent van Gogh and died in 1997 at the age of 122.
Could a little tinkering turn us all into Jeanne Calments? A large number of men who have made fortunes in Silicon Valley believe so — or at least are trying to recast aging as merely another legacy system in need of recoding. Oracle co-founder Larry Ellison’s Ellison Medical Foundation has spent more than $400 million on aging research. In 2013, Alphabet’s Larry Page announced a moonshot life-extension project called Calico, and XPrize founder Peter Diamandis partnered with genome sequencer J. Craig Venter to found a competing company called Human Longevity Inc. Paul F. Glenn, an 85-year-old venture capitalist who watched his grandfather die of cancer, launched an aging-science foundation more than 50 years ago that has since funded a dozen aging-research centers around the country. Peter Thiel is 37 years Glenn’s junior but equally desperate to find a death cure: He has given at least $3 million to the Methuselah Foundation, the research vehicle for the extravagantly bearded, Barnumesque immortality promoter Aubrey de Grey. Thiel has also said he takes a daily dose of human growth hormone, and he was reported to have seriously explored the transfusion of blood from the young to the old.
Last year, MIT named Guarente’s lab the Paul F. Glenn Center for the Science of Aging Research. Guarente has done his best to ignore the whiff of panic emanating from aging billionaires and instead be grateful for the funding. Scientists have recognized since the 1930s that calorie-restricted diets extend life in mammals (we evolved, the thinking goes, to withstand periods of famine, downshifting our metabolism in order to defer reproduction until we were again in a time of plenty). Guarente was one of the first to discover a single gene with a linchpin role in the process: in his case, a class of molecules called sirtuins. Now, aging science is in a growth spurt, with an accelerating race to develop compounds that target such master genes. The idea, and the premise of Basis, is that certain compounds might trick our bodies into thinking they’re starving (thereby extending our lives) without our having to feel hungry.
But from its birth in the early 1990s, the field of geroscience has faced significant impediments. Coming on the heels of centuries of humbug (e.g., Ponce de Leon, crushed dog testicles, Ted Williams’s frozen head), it has had to overcome a near-universal presumption of quackery. It is also an awkward match with contemporary drug research, which is organized around addressing specific maladies. Since aging is a risk factor rather than a disease — in the language of the FDA, it’s never been considered an “indication” — pharmaceutical companies are disincentivized from developing broadly aging-targeted drugs, and foundations tend to reserve their grant money for cancer, Alzheimer’s, and the like. Also, the FDA requires expensive human trials to move a drug through its approval process. Since a drug designed to treat people who are already healthy would have to be remarkably free of side effects to justify approval, and since there isn’t consensus on precisely which biomarkers would prove an anti-aging drug’s effectiveness, no FDA-approved anti-aging drug has come to market. It took until last year for the agency to greenlight the first aging-targeted human trial, one that tests whether the drug metformin, which has already been approved to treat diabetes, might also target calorie-restriction genes. But even if that test is successful, it would still take years for the FDA to approve the drug’s use for non-diabetic consumers.
Guarente has a higher risk tolerance than most of his peers (as a kid, he sprinted past security to get into a Beatles concert), and when he was convinced he had developed a pill that could extend his own health span, he chose to pursue a novel path to market. Because the two active compounds in Basis, pterostilbene and NR, are natural (occurring in blueberries and milk, respectively) and have long been available separately as supplements, Elysium has been able to skip the FDA gauntlet and sell its capsules immediately.
The agility that comes with bypassing federal regulation has an obvious cost: Guarente and his advisory board are the only scientific credibility Elysium can claim. The company stresses that it is using only compounds supported by hundreds of peer-reviewed papers, that it enforces high manufacturing standards, and that it is conducting a human trial (currently 120 people between the ages of 60 and 80 are participating). But the primary way in which Elysium distinguishes itself from the retail supplements business is Guarente himself, who is in a very real sense monetizing his reputation. “I’m there to really keep a lot of pressure on the company to do human trials and testing,” he told me. “Never, ever, make a claim that’s not substantiated by evidence.”
These steps haven’t spared the company from critics leery of eminent academics slumming it in the nutraceuticals sewer. Even colleagues sympathetic to Guarente’s enthusiasm point out that Elysium’s rigor is provisional, its evidence incomplete — while animal studies have been encouraging, the company is selling a product whose effects on humans have yet to be proved. “I am someone who is disappointed when I see efforts from major scientists to try to profit from something like this before the clinical trials are in that are designed to test for safety and efficacy,” says S. Jay Olshansky, of the University of Illinois at Chicago, who studies the public-health implications of longevity and is involved in the FDA metformin trial. Both pterostilbene and NR are generally recognized as safe under FDA guidelines (though an FDA spokesperson stressed that only NR had been evaluated by the FDA, and not in capsules.).Still, even Guarente wrestled with the decision to launch the company. “I had second thoughts,” he says. “I thought it was going to work, but I thought along the way there would be raised eyebrows and skepticism.”
Guarente has been taking Basis for two years, but it’s a good bet that he is not among those who have observed hair growth as one of the pill’s effects. At 64, he looks neither particularly young nor particularly old. His genes favor a long life, but he has seen how health span can be as important as life span. His father lived to be 83 and was in good health until being diagnosed with pulmonary fibrosis, whereupon he quickly lost lung function, requiring oxygen tanks; Guarente’s mother lived till age 89 but was “very frail and demented” by the time she died this June. After a rocky start — in his memoir, Ageless Quest, Guarente cops to quitting smoking when he was in third grade — he has lived a generally healthy life. Besides Basis, he takes a low-dose statin, aspirin, and vitamin D; weighs himself every day; eats a mostly Mediterranean diet (red wine included); and does a mix of cardio (on the elliptical machine, ever since his knees wore out and he had to stop running) and strength training three days a week at a gym near his home in the Boston suburb of Newton.
As we walked around the MIT campus one day this spring, Guarente pointed out a memorial to Sean Collier, the police officer shot and killed by one of the Boston Marathon bombers. A film about the bombing happened to be shooting in the area, and Guarente had recently received a call from the office of director Peter Berg, who was interested in having dinner. “I think it’s gotta be because of the pill,” Guarente said. Besides presenting him with interesting opportunities like meeting Berg, his work is also a magnet for kooks. There was the inventor who sent him an “anti-aging toothpaste” (hitch: The active ingredient was an enzyme known to degrade DNA), and also the woman who sent him unhinged letters and then showed up at MIT. “I’m a little worried, once Elysium starts to get a lot of attention, that it’s going to be a negative for my family,” Guarente said.
We passed the day-care center where his 5-year-old son is enrolled. The boy’s mother, to whom Guarente is married and with whom he also has an 11-year-old daughter, is a Bulgarian woman 20 years his junior who has an administrative job at MIT. Guarente has a third child, a son from his first marriage, but is unable even to find him, because he is a computer programmer specializing in encryption who has managed to scrub the internet of clues to his whereabouts. “I have a few addresses that I think are candidates,” Guarente said.
Guarente got into the whole defy-death racket as an outgrowth of a midlife crisis. He’d always been drawn to areas of research where there were still large blank spots on the map. He’d studied molecular biology because at the time it was a hot new field, but by 1990, he was divorced and single and looking for a new direction for his lab. Around then, two new graduate students proposed that they study aging in yeast. Two years later, they had identified specific yeast strains that aged less well than others. It was an opening.
“I was thinking if we were lucky, there’d be one cause of aging,” Guarente recalls of those early days. That was wishful, but they did find a cause of aging. It was an exciting finding (as yeast findings go). Though not generalizable to higher life-forms, much less humans, it was still a breakthrough, and the discovery resulted in Guarente sitting across from Willow Bay on Good Morning America. A later study would link NAD, a coenzyme critical to metabolism and which is known to diminish with age, with sirtuins. (NR, one of the two compounds in Basis, is a precursor that converts to NAD in the body.)
At the time, Guarente lived alone, often blasting Green Day at home and sinking all his time into research. His lab, populated with a growing number of ambitious students, thrummed with a boisterous spirit that was part camaraderie, part rivalry. Guarente and many of those students tell similar stories of peers and friends thinking they were crazy. There were no lucrative arrangements being proposed by biotechnology firms.
But that would soon change. In 1999, Guarente became co-founder of Elixir Pharmaceuticals, which aimed to develop drugs targeting sirtuins. And Guarente’s lab graduates would become some of his most prominent competitors. Matt Kaeberlein was on the front page of the New York Times recently for his experiment aimed at extending the lives of dogs with rapamycin, a compound first found in a soil sample on Easter Island in 1964, which for decades had been used as an immunosuppressant in organ transplants and which turns out apparently to operate on the body using the same mechanism as calorie restriction. Brian Kennedy, one of the two original Guarente grad students doing yeast-aging research, now heads the Buck Institute for Research on Aging (another Glenn center) and chairs the board of Mount Tam Biotech, a company developing a rapamycin-based anti-aging drug. And then there’s David Sinclair, an Australian who joined Guarente’s lab as a post-doc in 1995 and who made resveratrol, of red-wine-is-good-for-you fame, a household molecule. It was Sinclair who parlayed this discovery into the field’s biggest biotech firm, Sirtris, which was acquired by GlaxoSmithKline in 2008 for $720 million.
Sinclair’s discovery also provided a lesson about the danger of hype for a cluster of scientists exploring such a wish-fulfilling field. Suddenly, Sinclair was bouncing around TV calling resveratrol “as close to a miraculous molecule as you can find.” “David was a little over the top,” Guarente says. “I mean, he was saying, ‘If we’re right about this, it’s the most important discovery of all time.’ And that ticks people off.” When GSK shut down the biotech’s Cambridge offices a few years after buying it, laying off a number of employees and folding what remained into the larger corporation, many scientists in the field pounced. They included Guarente-lab alumni like Kennedy and Kaeberlein, who believe a molecule called Target of Rapamycin is a better bet than sirtuins for anti-aging efforts. While resveratrol had been shown to activate sirtuins in yeast, they pointed out, it had mixed results in animal studies, proving effective in fat mice but not regular-size ones. Both Sinclair and Guarente, who are paid consultants to GSK, insist that the company hasn’t given up on sirtuins, or resveratrol-related activators, but Sinclair has clearly been chastened. “At the time, I thought it important to bring attention to the field and show that it was legitimate,” he told me, “but I regret that I was a lightning rod for criticism.”
For Guarente, watching the boom and bust of resveratrol was as motivating as it was unnerving. He redoubled his own efforts to be the first to bring an anti-aging pill to market, even as he and Sinclair squabbled with Kennedy and Kaeberlein in the press. At times, the interpersonal strife can seem like nothing so much as the professional equivalent of a red Maserati convertible, a time-slowing denial of the ultimate stakes that bind the men: their shared obsession with combating aging, as every one of them gets older. “I’m increasingly eager to get something, a product that will slow down the train,” Guarente acknowledges.
For a company seeking to profit from life’s endgame, the Elysium Health offices in Soho hum with youthful energy. On a recent morning, Guarente, who was visiting from Boston, joined one of his two young co-founders, COO Dan Alminana, in a meeting with a prospective investor for a $20 million funding round. They sat in a glass conference room while dozens of young employees worked in the main space, speaking quietly or typing at computers. A row of service representatives sat fielding customer inquiries.
Not accidentally, the room had the feel of a Silicon Valley start-up. A Warby Parker “platform innovation” specialist sits on Elysium’s advisory board, as do a Nike designer and a “communications” professional from the DNA-testing company 23andMe. Eric Marcotulli, Elysium’s CEO, told me that the company aspires to be seen not as another supplement retailer, like GNC, or Big Pharma player, like Merck, but alongside tech companies like SpaceX, Tesla, ancestry.com, and Uber. Companies that are, he says, “retrospectively obvious.”
Marcotulli is an alumnus of prominent Menlo Park–based venture firm Sequoia Capital. A compact former wrestler who has long experimented on himself with protein powders and the like, he was self-quantifying before it was a thing, and he wears his Apple Watch at night to track his sleep. He also practices intermittent fasting, which means he consumes no calories during the 18 hours between 6 p.m. and noon. He was getting his M.B.A. at Harvard when a teacher assigned a case study on Sirtris. Later, during his VC days, he began reaching out to geroscientists, and he and Guarente found common cause. “We think we’re the world’s first consumer life-sciences company,” Marcotulli says. “What was the last new product in the consumer health market?”
The theory behind Basis is in part an evolution of the theory behind drinking red wine: One of its main ingredients, pterostilbene, is considered a more powerful version of resveratrol, with a more convincing track record in the lab. As for NR, by increasing NAD levels in our cells, it in turn appears to reverse mitochondrial decay. In a 2013 scientific paper, Sinclair announced that a single week of injections of an NAD precursor into elderly mice had made their muscles look young again, though without restoring their strength. Both compounds aim to activate sirtuins, and the hope is that together they might amplify what each does individually.
Like others I’d spoken to, Marcotulli studiously avoided saying anti-aging, a forbidden term among anti-aging scientists loath to be associated with the field’s dubious past. At the same time, Elysium can’t help but trade on the hope and ambition implicit in that hype — hence a certain amount of consternation about the eminent scientists on the company’s payroll. “There are lots of desperate boomers looking for something,” says Bill Gifford, the author of the best-selling book Spring Chicken, which chronicles developments in anti-aging science. “But frankly, I’m kind of shocked all those big-name scientists signed on to this thing that’s two very common, easily obtained supplement ingredients.”
That day at the Elysium offices, advisory board member Jack Szostak, who won the Nobel Prize for Physiology or Medicine in 2009, was visiting, and we spoke in an empty space down the hall where the company would soon be expanding. Szostak has known Guarente for 30 years (“the yeast-genetics community, everybody knows everybody”), and his official role at Elysium is to keep an eye out for compounds that, like Basis, could target health maintenance rather than specific diseases. I asked him if he had any discomfort selling an unproven product. “To follow a large number of people for a long period of time is an expensive undertaking,” he observed.
This argument, that the cart had to be put before the horse in order to get the horse to move, is one I heard from several defenders of Elysium’s approach. But even advisory board member James Kirkland, who leads the Mayo Clinic’s Robert and Arlene Kogod Center on Aging, said, when asked about this concern, “I think that’s a good point.” Kaeberlein, Guarente’s former protégé, is sharper: “They have the legal right to market this compound to people without any real knowledge of what it’s going to do — good, bad, or indifferent — in the long run. Is it something they should be doing? I’m not qualified to make that moral argument. We each have our own view as a scientist what level of evidence do we need to feel comfortable staking our scientific reputation on that and making general recommendations to the general public. You can probably guess where my opinion is.”
For me, as that first month taking Basis ticked by, this question had become more than academic. This was true for many of these scientific advisers, and at least some of them are guinea-pigging themselves. Sir Richard Roberts, a 72-year-old Nobelist who also sits on Elysium’s board, says that both he and his wife take Basis. “The only thing I’ve noticed, and this was only because someone mentioned they’d noticed it too,” Sir Richard said, “the skin on my elbows, which I always noticed was pretty rough, was now much smoother.” Robert Nelsen, a leading biotech venture capitalist who has invested in Elysium and takes Basis, told me, “I feel younger than I am,” and said he can do more push-ups now. (Nelsen, who is 53, also takes metformin, despite not having diabetes. “My partners think I’m nuts,” he says.)
Then again, all these people are financially and reputationally incentivized to believe in Basis. Even Nelsen acknowledged he could be experiencing a placebo effect. I asked other scientists, outside Elysium’s orbit, whether they take the pill. Olshansky told me he takes nothing: He tries to exercise daily and watch what he eats. Kennedy, likewise, takes nothing: “I said I’m going to wait till I’m 50 before I start taking anything. I run, I try to keep my caloric level down, I manage stress.” Kaeberlein takes nothing but says he’s “getting more and more tempted to take rapamycin in a low dose.” Sinclair, who now co-directs a Glenn-funded center at Harvard, still takes resveratrol every day and also takes an NAD booster (he has his own biotech company, currently in stealth mode, focused on that booster).
Sinclair did say that Basis is “based on solid science” and, if he didn’t have his own NAD booster, he’d “strongly consider” taking it. Was I, then, on safe ground taking it? There was a long pause on Sinclair’s end of the line. “You’re never safe assuming anything,” he said. “The results from studies indicate it should be safe.” And effective? Another pause. “I’d rather not say anything that definitive.”
My confidence waned. None of these scientists deemed Basis something they urgently need to be taking. Maybe it would help. Maybe it wouldn’t. Like Dylar, the black-market drug in Don DeLillo’s White Noise that cures the fear of death, the true payload of Basis and its coming wave of peers, whatever their physical benefits, may be a balm for existential terror. Side effects may include an obsession with death, reinforced every morning when you swallow your pill.
“I’ve had many interesting conversations with aging baby-boomers with money wanting to know what to do with it,” says Father Nicanor Austriaco, a bioethicist at Providence College. “People say, ‘I want to live longer, ’cause the last 40 years I’ve messed up.’ My question is: If you’ve not gotten 40 years right, what makes you think you will if you have another 40?”
Austriaco has unique credentials to opine on the matter. His religious conversion, and decision to become a Catholic priest, occurred just as his time in Guarente’s lab was coming to an end; he had been the second of the two graduate students who first undertook aging research in yeast back in 1991. “For a long time, he thought I was incredibly crazy and nuts,” Austriaco says.
Austriaco recently took part in a conversation at the Vatican about “enhancement” — everything from transhumanism to crispr technology (a new technique that allows us to edit DNA very efficiently) to sirtuin regulators of the sort that Guarente has focused on — and laments how capitalist concerns have invaded molecular biology. “I’ve seen how it can distort the human person,” he says. “I’m hoping it will not distort the science at least in this field.” I asked him for his own longevity practices. “I pray,” he said.
Guarente, a scientist and by necessity a salesman, has chosen a more worldly path. The morning after his meeting with the investor in Soho, he arrived at the U.N. to give a talk at something called the World Summit on Innovation & Entrepreneurship. Another panelist approached him, said he was taking Basis, and asked Guarente’s advice on the optimal time of day to take it. Guarente said morning was best, then returned his attention to his forthcoming presentation, which he was nervous about. His business partners had edited his slides and introduced mistakes he found embarrassing, including the made-up word neurogeneration.
Guarente has never been entirely at ease with the adjacency of science and money. He left Elixir, his previous biotech effort, after seven years, having lost power to the company’s venture capitalists. They ended up “not wanting to work on anything science-based but wanting to just import stuff that was already being sold elsewhere in the world, marginally related to aging, and call that an anti-aging company,” he told me. But he has also seen public funding of aging research, never particularly robust, become even scarcer. His disappointment with Elixir seems not to have tempered his enthusiasm for Elysium. As we talked, he sketched a vision of the new company’s future rich with possibility, bringing cutting-edge science to customers and contributing not just to the company’s bottom line but also to the greater social good. Elysium could, for instance, produce “the gold standard vitamin-D pill, and sell it basically at cost to get it out there.” I asked him why his business partners would want to forfeit a profit. “They won’t,” he acknowledged. “It won’t turn out that way. ”
*This article appears in the August 22, 2016 issue of New York Magazine.
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Scientists at Newcastle University believe a drug commonly prescribed for Type 2 diabetes could be routinely taken by Type 1 diabetic patients to slow the development or delay heart disease.
Metformin is an inexpensive treatment that is often used for Type 2 diabetes to lower blood sugar levels by reducing glucose production in the liver.
The drug is not regularly given to patients with Type 1 diabetes. However, for the first time, a clinical trial has revealed metformin can promote a patient’s ability to repair their own damaged blood vessels by increasing vascular stem cells.
Heart disease is the leading cause of illness in diabetic patients, accounting for more than half of all fatalities. Metformin may be used to lower Type 1 diabetic patients’ risk of developing this complication.
Findings of the clinical trial are published today in the journal, Cardiovascular Diabetology. This follows previous laboratory work at Newcastle University which explored the mechanism behind metformin.
Dr Jolanta Weaver, Senior Lecturer in Diabetes Medicine at Newcastle University and Honorary Consultant Diabetologist at Queen Elizabeth Hospital, Gateshead, led both studies.
She believes this new research is a major development in understanding the best ways to further improve treatment in Type 1 diabetes.
Dr Weaver said: “As the outcomes of heart disease is worse in diabetic versus non-diabetic patients, there is a need to identify additional treatment options.
“Metformin could routinely be used by patients with Type 1 diabetes to help lower their chances of developing heart disease, by increasing a repair mechanism created by vascular stem cells released from the bone marrow.
“Our research is an exciting step forward as it may have positive clinical implications for patients with increased risk of cardiovascular disease by improving their treatment options.
“For the first time, this study has shown metformin has additional benefit beyond improving diabetes control when given to patients with relatively well controlled Type 1 diabetes.
“We have established the drug increases patients own vascular stem cells, which will help delay or slowdown heart disease.
“Our findings also show that the cells associated with damaged blood vessels were reduced, confirming that the repair of blood vessels was taking place in our patients.”
Researchers studied a treatment group of 23 people aged 19-64 who had Type 1 diabetes for up to 23 years and had no evidence of heart disease.
Patients were given metformin at a dose they could tolerate, between one to three tablets a day, for eight weeks. Participants were advised to adjust their insulin to keep blood glucose levels safe.
Scientists measured patients’ stem cells directly in the blood and also grew stem cells in a test tube, observing how they behaved. Another cell type was also counted to assess damaged blood vessels.
The participants were matched with nine patients within the same age bracket who took standard insulin treatment and 23 healthy non-diabetic people aged 20-64.
Experts found that the stem cells of patients who took metformin were able to promote the repair of the blood vessels and there was an improvement in how vascular stem cells worked.
Type 1 diabetes is a lifelong autoimmune condition that develops when the pancreas does not produce any insulin, causing a person’s blood sugar level to become too high. It is estimated around 400,000 people in the UK have the condition.
Dr Weaver said: “We have shown that all our patients in the study had their insulin doses reduced after taking metformin and have not suffered any serious adverse effect.
“Patients with Type 1 diabetes may wish to consider discussing with their GP the possibility of adding metformin, even at a very low dose, to the insulin that they are taking. However, care needs to be taken to adjust insulin dose to prevent too low glucose levels.”
A pilot study was funded by Diabetes Research and Wellness Foundation and the extended study was financially supported by the Diabetes Research Fund in Gateshead.
Dr Eleanor Kennedy, Research Manager at Diabetes Research and Wellness Foundation, said: “The Diabetes Research and Wellness Foundation is delighted to have funded the initial pilot study that led Dr Weaver and her colleagues to conduct this small clinical trial.
“The results, which indicate that metformin, a drug commonly used in the treatment of Type 2 diabetes, could also have a powerful effect in people with Type 1 diabetes is unexpected.
“We hope that these results can lead to a much larger clinical trial.”
Quantity surveyor Alex Laws was part of the Newcastle University clinical trial and is delighted with the results of the study.
The 31-year-old, of Gateshead, was diagnosed with Type 1 diabetes at the age of just seven and has good control of her condition. She was enrolled on the clinical trial in the summer of 2013.
Alex said: “I was keen to be part of the clinical trial as I know how important research is into helping people with the condition – I previously worked in the medical research field.
“People with Type 1 diabetes can suffer from a number of complications, especially in the long-term, so it’s important as much as possible is done to limit serious problems.
“Heart disease is a concern for people with Type 1 diabetes so any treatment that can help with this and give an advantage to the patient is a good thing.”
Metformin improves circulating endothelial cells and endothelial progenitor cells in Type 1 diabetes: MERIT Study
Fahad W Ahmed, Rachel Rider, Michael Glanville, Kilimangalam Narayanan, Salman Razvi and Jolanta U Weaver.
Cardiovascular Diabetology. DOI: 10.1186/s12933-016-0413-6
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The existence of the mind/body connection was once completely shunned by mainstream science, with many dismissing it as mere pseudoscience. Fortunately, the conversation has shifted in recent years, thanks in large part to new scientific publications that have made it quite clear that our thoughts, feelings, and emotions play a crucial role in regulating our overall health and biology.
There are several examples from different areas of science that prove this. Going through all of the evidence showing the strength of this connection can be a daunting task, which is why this article will provide just a few examples to get you started. It should serve as a good introduction to the unfortunate reality that much has been overlooked when it comes to the business of healing and medicine.
The HeartMath Institute
Some of the most intriguing research in this field comes from the HearthMath institute. Their research has shed light on a number of fascinating discoveries about how our emotions can impact our health. Through their work (and the work of others), we know that positive emotions create physiological benefits in your body, and negative emotions do the opposite. You can simply boost your immune system by conjuring up positive emotions. The heart actually has a system of neurons which have both short term and long term memory, and these heart signals are sent to the brain, which in turn affects our emotional experiences.
They’ve also shown that the electromagnetic field emitted from the human heart can be measured up to several feet away from the human body, and by learning to shift our emotions we are actually changing the information that’s coded into these heart-radiated magnetic fields. It’s definitely fascinating stuff, so if you want to learn more about it you can check out their website, linked above, or this article I wrote approximately 2 years ago.
A large portion of HeartMath’s research focuses on these magnetic fields, and how not only other living creatures, but also Earth’s electromagnetic fields could connect in some way with our own and all other living things on the planet. You can read more about that here.
Science has made some stunning new discoveries when it comes to the role of the mind in controlling our biology. Epigenetics (the study of changes in organisms caused by modification of gene expression) has shown us that genes and DNA do not control our biology, but rather, DNA is controlled by signals from outside of the cell, which include the messages that stem from our thoughts.
One of the leading authorities on how our emotions can regulate genetic expression is cellular biologist Bruce Lipton. He gives a great in-depth explanation in his books The Biology of Belief and Spontaneous Evolution.
The Placebo Effect
The biology of belief can be demonstrated in a number of different ways. Neuroplasticity, or the ability of the brain to change its shape and how it communicates with the body based on a person’s thoughts and their perception of their environment, is one great example.
According Dr. Lipton:
The placebo effect should be the subject of major, funded research efforts. If medical researchers could figure out how to leverage the placebo effect, they would hand doctors an efficient, energy-based, side effect-free tool to treat disease. Energy healers say they already have such tools, but I am a scientist, and I believe the more we know about science of the placebo, the better we’ll be able to use it in clinical settings. (Taken from his book linked above)
There are some fascinating publications regarding the placebo effect, but more research in this area is desperately needed. One such publication includes a Baylor School of Medicine study, published in 2002 in the New England Journal of Medicine. It looked at surgery for patients with severe and debilitating knee pain. Many surgeons know there is no placebo effect in surgery, or so most of them believe. For the study, patients were divided into three groups. The surgeons shaved the damaged cartilage in the knee of one group. For the second group, they flushed out the knee joint, removing all of the material believed to be causing inflammation. Both of these processes are standard for people who have severe arthritic knees. The third group received a “fake” surgery; the patients were only sedated and tricked into thinking they had actually undergone the surgery. For these patients, doctors made incisions and splashed salt water on the knee as they would in normal surgery. They then sewed up the incisions like the real thing. All three groups went through the same rehab process, and the results were astonishing. The placebo group improved just as much as the other two groups who had surgery. The surgeon involved in the study stated that his “skill as a surgeon had no benefit on these patients” and that “the entire benefit of surgery for osteoarthritis of the knee was the placebo effect.”
At the turn of the nineteenth century, physicists started to explore the relationship between energy and the structure of matter. In doing so, the belief that a physical, Newtonian material universe that was at the very heart of scientific knowing was dropped, and the realization that matter is nothing but an illusion replaced it. Our universe is more than just a physical mechanical one, and our biology is more than just a physical ‘thing.’ With the advent of quantum physics, scientists have realized the flaws in Newtonian physics, as quantum physics shows us that the invisible, immaterial realm is actually far more important than the material realm.
“I regard consciousness as fundamental. I regard matter as derivative from consciousness. We cannot get behind consciousness. Everything that we talk about, everything that we regard as existing, postulating consciousness.”
– Max Planck, theoretical physicist who originated quantum theory, which won him the Nobel Prize in Physics in 1918
This applies to the biology of our bodies as well. It is much more than a mechanical, physical entity. A true examination and interpretation of human biology cannot be adequately done without addressing the non-physical factors that play a role in regulating it, like thoughts and emotions.
The quantum double slit experiment is a very popular experiment used to examine how consciousness and our physical material world are intertwined. It effectively documents how factors associated with consciousness and our physical material world are connected in some way.
One potential revelation of this experiment is that “the observer creates the reality.” A paper published in the peer-reviewed journal Physics Essays by Dean Radin, PhD, explains how this experiment has been used multiple times to explore the role of consciousness in shaping the nature of physical reality. (source)
All of the research being conducted in the areas mentioned above and more are helping to increase awareness about something that has tremendous implications for us all.
“The day science begins to study non-physical phenomena, it will make more progress in one decade than in all the previous centuries of its existence.”
Emotional Pain Charts
There are mountains of books and papers that have been published on the mind body connection, above is just a tiny bit of information that’s out there, a general overview. As far as what type of emotion and how it causes something specific within the body, the mechanisms of that have yet to be identified. This is an ancient science, and concepts like these require more learning on our part, and more funding and study in the world of science. Science has always been slow with regards to ‘catching up’ on all that was lost in our past, but we are indeed doing so. Quantum physics and ancient eastern philosophy are a perfect example. That being said, below are a couple of emotional pain charts that theorize the specifics of this kind of thing. Personally, I have no doubt that negative emotions feed several different types of ailments and diseases within the body, regardless of whether or not we don’t quite understand it fully, the connection is clearly there and that seems to be firmly established in scientific literature.
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Hemp has been called a plant of “major economic importance,” as it grows like a weed, yet can be used in the production of food, personal care products, textiles, paper, and even plastic and construction materials.1
Valued since ancient times as a fiber source for textiles, the hemp industry eventually made it to the US, where it flourished in the mid-1800s, through World War I and again briefly during World War II, when the war cut off supplies of fiber.2
In the US, the cultivation of hemp has been banned since the 1970s when the federal Controlled Substances Act took effect. The law doesn’t distinguish between marijuana, the drug, and hemp, the plant, despite major scientific differences.
Ironically, the US is the world’s largest consumer of hemp products, yet is the only industrialized country that also outlaws its production. As a result, all US hemp products – a more than $600-million market in the US – are imported.3 As noted in “Hemp: A New Crop with New Uses for North America:”4
“Cannabis sativa [hemp] is extremely unusual in the diversity of products for which it is or can be cultivated. Popular Mechanics magazine (1938) touted hemp as ‘the new billion dollar crop,’ stating that it ‘can be used to produce more than 25,000 products, ranging from dynamite to Cellophane.'”
What’s the Difference Between Hemp and Marijuana
Hemp and marijuana come from the same plant species, Cannabis sativa, but there are noted differences between the two plants. They both contain cannabidiol (CBD), which has medicinal properties. The amount of CBD however, differs greatly between the two.
Dosing, therefore, is dramatically different when you to try to use hemp in lieu of cannabis for medicinal purposes, as the latter, cannabis, is up to 100-fold more potent.
Another difference that appears to matter in terms of its usefulness as medicine relates to differing terpene profiles. Hemp contains very little of these valuable medicinal compounds.
Lastly, there’s the tetrahydrocannabinol (THC) content. THC is the psychoactive component of marijuana; it’s the molecule that makes you feel “stoned.” (While cannabidiol (CBD) also has certain psychoactive properties.
It does NOT produce a high.) By legal definition, hemp cannot have more than 0.3 percent tetrahydrocannabinol (THC) in it. So to summarize:
- Hemp has less value for medicinal uses, as it only contains about 4 percent CBD and lacks many of the medicinal terpenes and flavonoids.It also contains less than 0.3 percent THC, which means it cannot produce a high or get you stoned. While hemp may not have the same medicinal uses as marijuana, it does have excellent nutritional value that may boost health.
- Marijuana can act as a potent medicine courtesy of high amounts (about 10 to 20 percent) of CBD, critical levels of medicinal terpenes, and flavonoids, as well as THC in varying ratios for various diseases. The higher the THC, the more pronounced its psychoactive effects.
- Genetic Difference Between Hemp and Marijuana Uncovered
If there were still any question over whether or not hemp and marijuana are two different plants, it should be put to rest with the publication of a new study that shows the genetic difference between hemp and marijuana.5
Researchers from the University of Minnesota’s (U of M) College of Biological Sciences and College of Food, Agricultural, and Natural Resource Sciences belong to one of the few groups of US scientists that have been granted federal clearance to study cannabis.
After more than 12 years of research, the team found a single gene that is responsible for the genetic differences between hemp and marijuana. As noted by Medical Daily:6
“While hemp produces a non-euphoric cannabidiol (CBD) with approximately 0.3 to 1.5 percent tetrahydrocannabinol (THC) concentration, marijuana is packed with between five to 10 percent (or even higher) psychoactive THC concentration.”
The researchers believe they have “indisputable evidence” that hemp and marijuana should be regarded as separate plants.
Nearly half of US states now separate hemp from marijuana. George Weiblen, a professor with a joint appointment in the U of M’s College of Biological Sciences and College of Food, Agricultural and Natural Resource Sciences, said:7
“It’s a plant of major economic importance that is very poorly understood scientifically… With this study, we have indisputable evidence for a genetic basis of differences among cannabis varieties, further challenging the position that all cannabis should be regulated as a drug.”
- Health Benefits of Hemp
One of the under-appreciated benefits of hemp, at least in the US, is as a food source. Hemp seeds, which are technically a nut and are also known as “hemp hearts,” are rich in healthy fats, protein, and minerals.
Hemp seeds are usually consumed after the hard outer shell is removed, leaving just the soft, creamy “heart” behind. The seeds have a slight nutty flavor, making them incredibly versatile for use in cooking, baking, or for adding to smoothies and salads. Some of their primary health benefits include:8
- Excellent Source of Nutrition
Hemp seeds are composed of more than 30 percent healthy fats, including the essential fatty acids linoleic acid and alpha-linolenic acid (plant-based omega-3). According to research published in Nutrition & Metabalism
“Dietary hempseed is… particularly rich in the omega-6 fatty acid linoleic acid (LA) and also contains elevated concentrations of the omega-3 fatty acid α-linolenic acid (ALA). The LA:ALA ratio normally exists in hempseed at between 2:1 and 3:1 levels. This proportion has been proposed to be ideal for a healthy diet.”
Hemp seeds also contain gamma-linolenic acid, which supports the normal function and growth of cells, nerves, muscles, and organs throughout your body.
Hemps seeds are about 25 percent protein and also provide nutrients including vitamin E, phosphorus, potassium, magnesium, sulfur, calcium, iron, and zinc.
- Heart Health
- Hemp seeds contain numerous heart-healthy compounds, including the amino acid arginine. L-arginine is a precursor to nitric oxidein your body. It has been shown to enhance blood flow and help you maintain optimal blood pressure. Nitric oxide signals the smooth muscle cells in your blood vessels to relax, so that your vessels dilate and your blood flows more freely.
- This helps your arteries stay free of plaque. When you have inadequate nitric oxide, your risk for coronary artery disease increases. The gamma-linolenic acid found in hemp seeds is anti-inflammatory, another bonus for heart health. Past research has also shown hemp seeds may help reduce blood pressure, decrease the risk of blood clots, and boost recovery after a heart attack.
- Skin Health
- Fatty-acid deficiency can manifest in a variety of ways, but skin problems such as eczema, thick patches of skin, and cracked heels are common. Hemp seeds are a rich source of fatty acids in the optimal omega-6 to omega-3 ratio. Research suggests hempseed oil may improve symptoms of atopic dermatitis10 and potentially provide relief from eczema.
- Plant-Based Protein
- Although I believe protein from high-quality animal sources is beneficial for most people, if you are following a plant-based diet, hemp makes a healthy source of protein. With all of the essential amino acids and an amount of protein similar to beef (by weight), hemp seeds are an excellent form of plant-based protein.
- Two to three tablespoons of hemp seeds provides about 11 grams of protein, complete with the amino acids lysine, methionine, and cysteine. Two main proteins in hemp seed protein, albumin and edestin, are rich in essential amino acids, with profiles comparable to soy and egg white. Hemp’s edestin content is among the highest of all plants. Hemp protein is also easy to digest because of its lack of oligosaccharides and trypsin inhibitors, which can affect protein absorption.
- PMS and Menopause Symptoms
- The gamma-linolenic acid (GLA) in hemp seeds produces prostaglandin E1, which reduces the effects of the hormone prolactin. Prolactin is thought to play a role in the physical and emotional symptoms of premenstrual syndrome (PMS). GLA in hemp seeds may also help reduce the symptoms of menopause. 11
- Whole hemp seeds contain both soluble and insoluble fiber, which may support digestive health and more. Soluble fiber dissolves into a gel-like texture, helping to slow down your digestion. This helps you to feel full longer and is one reason why fiber may help with weight control. Insoluble fiber does not dissolve at all and helps add bulk to your stool. This helps food to move through your digestive tract more quickly for healthy elimination.
- Fiber plays an essential role in your digestive, heart, and skin health, and may improve blood sugar control, weight management, and more. Please note that only whole hemp seeds contain high amounts of fiber; the de-shelled hemp seeds or “hearts” contain very little fiber.
Agricultural Hemp Returns to Kentucky
Kentucky was once home to a flourishing hemp industry, but once hemp was outlawed, tobacco became the go-to cash crop. That is now slowly changing once again, as farmers take advantage of the five-year pilot Industrial Hemp Research Program, which was established by James Comer, Kentucky’s commissioner of Agriculture.12 The program is one recently launched in a number of states, where permission has been granted for industrial hemp to be grown for research purposes. As reported by Newsweek:13
“Kentucky led the U.S. industrial hemp business until the end of the Civil War, when production of the crop declined and was generally replaced by tobacco. The Marihuana Tax Act of 1937 put the kibosh on all production and sales of cannabis, including industrial hemp, but the crop saw a rapid resurgence during World War II. Hemp fiber became essential to produce military necessities such as uniforms and parachutes.
The U.S. Department of Agriculture launched its national ‘Hemp for Victory’ program, which provided seeds and draft deferments to farmers. In 1942, farmers planted 36,000 acres of hemp seed. A USDA-funded informational film from that year noted that ‘hemp grows so luxuriantly in Kentucky that harvesting is sometimes difficult.'”
Comer reportedly wants to “single-handedly turn industrial hemp into Kentucky’s No. 1 cash crop” and “breathe new life into family farms that have lost millions of dollars with the fall of the tobacco industry.”14
Currently, most industrial hemp comes from China, but the plant could bring great economic growth to areas of the US. Among the many products provided by industrial hemp are:
- Cannabidiol (CBD), the medicinal compound, which can be extracted from the leaves, blossoms, and stems
- Cannabis oil, which comes from cold-pressing the seeds and can be used for cooking, cosmetics, and beauty products
- Fiber, which can be used as a substitute for cotton, wood, and plastic, with potentially endless uses
- Hemp seeds, which are poised to become a human superfood and could also be used in animal feed
Hemp Could Provide an Environmentally Friendly Alternative to Plastic Hemp plastic is a “material of the future” that could drastically cut down on the need for plastics and their devastating toll on the environment. In some cases, standard plastics may be reinforced with hemp, which may account for up to 80 percent of the plastic’s weight. Hemp can also be used to make 100 percent hemp plastic, which is recyclable and can be 100 percent biodegradable.
Currently, the most common type of hemp plastics are those infused with hemp fibers, which means less plastic is used and the resulting product is more durable (hemp plastic is said to be five times stiffer and 2.5 times stronger than polypropylene).15 According to Hempowered.com:16
“Using sustainable and renewable natural plant fibers (such as hemp, flax, jute, and kenaf) and through industrial production techniques that mix them into plastics, a new award winning (Biomaterial of the year 2010) granule has been made from a combination of hemp with polypropylene, thus reducing the use of petroleum products.
… Their recoverable component comes from these natural plants and can make up over half of their weight, up to 80 percent. All these features make them suitable for the production of durable products. Hemp Plastic granules offer many advantages like good insulation, dimensional stability at high temperatures, a high thermal deformation temperature, and impermeability… The granules are currently produced for a range of applications in automobiles, construction materials, packaging, toys, and electronic products and launched onto the market in 2010.”
Hemp Could Soon Be Reclassified As an Agricultural Crop
Currently, hemp can only be grown in select US states for research purposes. However, even then the US Drug Enforcement Administration makes it challenging for growers. According to Newsweek:17
“The DEA’s cannabis eradication program provides funding to local law enforcement to form a SWAT team of ‘cowboys flying around in helicopters.’ They have been known to sweep through private farms to confiscate the plants, and have even been known to mistake okra for marijuana.”
A bill in Congress could change that as, if passed, it would reclassify hemp from a narcotic to an agricultural crop. Rep. Jared Polis (D-Colo.), a co-sponsor of the bill – the Industrial Hemp Farming Act of 2015 — told the Huffington Post:18
“The federal ban on hemp has been a waste of taxpayer dollars that ignores science, suppresses innovation, and subverts the will of states that have chosen to incorporate this versatile crop into their economies… I am hopeful that Congress will build on last year’s progress on hemp research and pilot programs by passing the Industrial Hemp Farming Act to allow this historical American crop to once again thrive on our farmlands.”
- 1, 3, 6, 7 Medical Daily July 20, 2015
- 2, 4 Trends in new crops and new uses, 2002, Hemp: A new crops with new uses for North America
- 5 New Phytologist July 17, 2015
- 8 Authority Nutrition September 2015
- 9 Nutr Metab (Lond). 2010; 7: 32
- 10 J Dermatolog Treat. 2005 Apr;16(2):87-94
- 11 Methods Find Exp Clin Pharmacol. 2010 Sep;32(7):467-73
- 12, 13, 14, 17 Newsweek October 11, 2015
- 15, 16 Hemppowered.com Hemp Plastic Solution
- 18 Huffington Post January 22, 2015
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A team of US and Brazilian researchers have used a synthetic sex hormone to stimulate production of a naturally occurring enzyme called telomerase that is capable of reversing ageing and has been dubbed a possible “cellular elixir of youth.”
While in embryos, telomerase is expressed by practically every cell. It can then only be produced in cells that are constantly dividing, such as blood-forming stem cells, which can differentiate into various specialized cells, scientists say. Certain cells avoid aging by using telomerase to lengthen their telomeres, which are DNA-protecting structures at the ends of chromosomes. The length of telomeres is a laboratory measure of a cell’s age, as each time a cell divides, its telomeres get shorter.
“In a healthy adult, telomere length varies from 7,000 to 9,000 base pairs on average. A normal person’s telomeres lose 50 to 60 base pairs per year, but a patient with telomerase deficiency can lose between 100 and 300 base pairs per year,” said Professor Rodrigo Calado, one of the scientists behind the research, the results of which were published in the New England Journal of Medicine.
Telomerase deficiency may cause some blood-related diseases, such as aplastic anemia. In the recent study, scientists treated 27 patients having telomere diseases with a steroid called danazol, a synthetic male hormone, leading to telomere elongation.
“In the patients who received danazol, telomere length increased by 386 base pairs on average over two years,” Calado said.
The research was based on previous findings that showed that androgens, which are converted into estrogens in humans, bind to female hormone receptors in the telomerase gene promoter region, stimulating expression of the enzyme in cells. The latest study “was designed to find out whether the effect we’d observed in the lab also occurred in humans, and the results indicate that it does,” the professor said.
While finding that sex hormones may be used to reverse one of the biological drivers of aging, researchers are cautious, as the risks of using the treatment in healthy people are not yet clear.
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By Dr. Mercola
It is now estimated that 1 in 8 Americans are on serotonin reuptake inhibitors (SSRI) antidepressants1 and a shocking 1 in 4 among women in their 40s and 50s.2 Yet the U.S. suicide rate of 38,000 a year has never been higher.3
Clearly the glut of SSRI prescriptions is not lowering the national suicide rate; rather there is compelling evidence that the popular pills are actually contributing to suicide.
SSRIs and Violence
The first suspicion that SSRIs can cause dangerous and unintended psychiatric effects was a Kentucky shooting in 19894 in which pressman Joseph T. Wesbecker entered his former workplace, Standard Gravure, killed eight people, injured 12 and committed suicide after being prescribed Prozac.
Families of the wounded and killed soon filed a lawsuit against Prozac maker Eli Lilly and Company, claiming the SSRI contributed to the violence. The case went to a jury that sided with Lilly.
Yet three days before the shooting, Wesbecker’s psychiatrist had written “Prozac?” in his patient notes as a possible explanation of his bizarre behavior.
Since the Standard Gravure killings, psychiatrists, drug safety advocates and bereaved families have consistently tried to expose links between SSRIs and suicides but are hampered by mainstream safety data that deny a suicide link.
Study Suggests ‘No Suicide Link’ Is Not to Be Trusted
However, a recent study suggests the “no suicide links” findings are not necessarily to be trusted, noting that: “Therapists should be aware of the lack of proof from RCTs (randomized control trials) that antidepressants prevent suicides and suicide attempts.”5
Dr. David Healy, professor of psychiatry at Bangor University and author of 20 books including “The Antidepressant Era,” “The Creation of Psychopharmacology,” “Let Them Eat Prozac,” “Mania,” and “Pharmageddon,” heartily agrees that the SSRI statistics given to the public is problematic.6
“People haven’t had access to the data. There have been no publications around it. This is one of the biggest problems on which there’s a huge amount of data, but to which we’ve got little or no access …
If we were getting our drug information from The New York Times instead of medical journals, we would all be a lot safer. When the Times reporter Jayson Blair was found to have fabricated stories, he was history.
But the editors and writers involved with journal fraud still have their jobs and the articles are not even retracted. In fact, Liz Wager, Ph.D., the chair of the Committee on Publication Ethics (COPE) is herself Pharma-linked.”
The COPE website said about Wager,7 its former chair, “Liz provides writing, editing, training and consultancy services for various pharmaceutical companies” (most recently AstraZeneca, Cephalon, Cordis Corporation, GlaxoSmithKline, Eli Lilly, Janssen-Cilag, Merck Serono, Mundipharma, Norgine, Novo Nordisk, Sanofi Pasteur and Vifor Pharma) at the time of the interview with Healy.
Healy estimates as many as 1,000 to 2,000 Americans on SSRIs kill themselves each year, when they otherwise would not have done so. Violent acts against others and birth defects are also linked to the pills, he says.
Suicides Linked to Antidepressants Number in the Thousands
Even as high level links between medical editors and the drug industry prevented accurate information from reaching the public, in 1997, drug safety activists launched a website called SSRIstories.com,8 which archived credible and published reports that cite the role of SSRIs and related antidepressants in suicides and other violent behavior.
There are now thousands of entries. “The kind of energy, rage and insanity seen in a lot of crimes today was not seen before SSRIs appeared,” said Rosie Meysenburg, a founder of the website in an interview shortly before her death.9
In addition to the thousands of suicides, “there are two cases of women on the SSRI Stories site who stab a man close to 200 times and a case of a man who stabs his wife over 100 times and then goes next door to the neighbor’s house and stabbed the neighbor’s furniture about 500 times.”
The SSRI stories archive includes people on SSRIs setting themselves on fire, violent elderly people (which is rare) and bizarre cases of kleptomania and female school teachers molesting their minor male students. The common denominator in all the recorded crimes is the drug.
Drug companies routinely blame suicides on the depression that was being treated, not the drugs — but the experiences of patients treated with the same drugs for non-mental indications like pain and the experiences of healthy volunteers cannot be written off as the “disease.”
The Dark Side of Cymbalta
In 2004, 19-year-old Traci Johnson who had no history of mental problems hung herself in the Eli Lilly Clinic in Indianapolis while testing the drug giant’s serotonin–norepinephrine reuptake inhibitor (SNRI) duloxetine, sold under the brand name Cymbalta, a type of antidepressant similar to SSRIs.10
The suicide did not delay the drug’s approval and wide use. In 2008, the Journal of Clinical Psychopharmacology describes a 37-year-old man with a stable marriage, stable employment and no history of mental problems trying to kill himself two months after being prescribed Cymbalta for back pain.
“The patient was unable to state exactly why he wanted to commit suicide,” wrote the four physician authors in the report, also noting that the man returned to normal when the drug was stopped.
The authors also report a 63-year-old man with no mental health history becoming suicidal two weeks after being put on Cymbalta for fatigue, insomnia and sadness, yet he too was “unable to explain why he was having thoughts of wanting to die.”
Other cases of healthy people committing suicide on Cymbalta have been reported11 and many still remember the suicide of Carol Gotbaum at Phoenix’s Sky Harbor International Airport who was on the drug. She was the stepdaughter-in-law of New York City’s public advocate at the time, Betsy Gotbaum.
Writing for Slate, reporter Jeanne Lenzer identified 13 suicides12 linked to Cymbalta besides Traci Johnson. Eli Lilly wanted to market the drug as a treatment for urinary incontinence too but withdrew its application and would not release the study data to Lenzer, she says. It may well have contained more evidence of suicide side effects.
The Drug Industry Still Fights Black Box Warnings Added in 2004
In 2004,13 in response to the outcry over antidepressant-linked suicides, the U.S. Food and Drug Administration (FDA) directed drug makers to add a “Black Box” warning to SRRIs and related psychiatric drugs, highlighting suicide risks and the need for close monitoring of children and adolescents for suicidal thoughts and behavior.
“Today’s actions represent FDA’s conclusions about the increased risk of suicidal thoughts and the necessary actions for physicians prescribing these antidepressant drugs and for the children and adolescents taking them.
Our conclusions are based on the latest and best science. They reflect what we heard from our advisory committee last month, as well as what many members of the public have told us,” said Dr. Lester M. Crawford, acting FDA commissioner at the time.
Unfortunately, then and now, drug industry funded doctors have tried to claim that the warnings scare doctors and patients away and heighten suicide. While it would be ridiculous to blame obesity on tighter restriction of obesity drugs, that is essentially what drug industry spokesmen have done with SSRI warnings and continue to do.
Even The New York Times was misled by such disinformation, reporting that SSRI warnings were causing a leap in suicides.
Journalist Alison Bass, however, revealed14 the paper on which the Times article was based was funded by a $30,000 Pfizer grant. The conclusions about higher suicides also turned out to be wrong because the researcher got his years mixed up.15
Contrary to drug industry claims about the warnings, the proportion of children and teens taking antidepressants actually rose in the U.S. after the Black Box was added from more than 1 percent to nearly 2 percent says Dr. Andrea Cipriani, associate professor in the department of psychiatry at the University of Oxford, in England.16
Still, both David Shern, Ph.D., president of Mental Health America, a group investigated by Congress for undisclosed industry funding17 and Dr. Charles Nemeroff, also investigated by Congress, blamed18 the Black Box warnings for rising suicides. Speaking to ABC News, Nemeroff said:19
“I have no doubt that there is such a relationship. The concerns about antidepressant use in children and adolescents have paradoxically resulted in a reduction in their use, and this has contributed to increased suicide rates.”
False Charges About Black Box Warnings Continue
Nemeroff left his post at Emory University in disgrace because of his drug industry links20 and a National Institutes of Health (NIH) grant he managed was suspended because of the conflicts of interest — a rare occurrence.21 Nor have the false charges about Black Boxes died down. Here is how a New York Times editorial read just last year.22
“Worse, antidepressants, which can be lifesaving, are probably being underused in young people. Their use fell significantly after the FDA issued its so-called black-box warning in 2004, stating that all antidepressants were associated with a risk of increased suicidal feeling, thinking and behavior in adolescents. That warning was later extended to young adults.
It’s not hard to understand why. The FDA’s well-intended warning was alarming to the public and most likely discouraged many patients from taking antidepressants. Physicians, too, were anxious about the admittedly small possible risks posed by antidepressants and were probably more reluctant to prescribe them.
This very small risk of suicidal behavior posed by antidepressant treatment has always been dwarfed by the deadly risk of untreated depression … Parents and teenagers, and their doctors, too, should not be afraid of antidepressants and should know that they can be very helpful. Indeed, with careful use and monitoring, they can be lifesaving. The only thing we should all fear is depression, a natural killer that we can effectively treat.”
Blaming underuse of drugs and falling sales on warnings that made patients or doctors “anxious” is not limited to antidepressants. Recently, industry-funded groups charged that warnings on the bone drugs called bisphosphonates about fractures and osteonecrosis of the jaw were scaring patients and doctors away and denying patients the drugs’ benefits.23
SSRIs Ignored in the Extremely High Rate of Suicide in the Military
During the wars in Iraq and Afghanistan, troop suicides were higher than combat fatalities themselves and the majority of the suicides were among troops who had never even deployed.24 But when a long awaited Army report came out, it largely blamed soldiers themselves for the deaths, especially highlighting illegal drug usage and barely mentioning the huge number of troops on prescription psychoactive drugs. In fact, the word “illicit” appears 150 times in the Army report and “psychiatrist” appears twice.25
At the time of the Army report, 73,103 prescriptions for Zoloft had been dispensed to troops, 38,199 for Prozac, 17,830 for Paxil and 12,047 for Cymbalta.26 In fact 4,994 troops at Fort Bragg alone were reported to be on antidepressants by the Fayetteville Observer.
Four years after the Army report, researchers addressed the military suicides in JAMA Psychiatry27 again not finding or considering the high prescribing of SSRIs within the military. The authors had financial links to Eli Lilly, GlaxoSmithKline, Ortho-McNeil Pharmaceutical, Janssen-Cilag, Pfizer, Sanofi-Aventis, Shire and Johnson & Johnson.
In a series during the Iraq and Afghanistan wars called “Medicating the Military,” when SSRI use was mushrooming, Military Times reported:28
“A Military Times investigation of electronic records obtained from the Defense Logistics Agency shows DLA spent $1.1 billion on common psychiatric and pain medications from 2001 to 2009. It also shows that use of psychiatric medications has increased dramatically — about 76 percent overall, with some drug types more than doubling — since the start of the current wars.
Troops and military health care providers also told Military Times that these medications are being prescribed, consumed, shared and traded in combat zones — despite some restrictions on the deployment of troops using those drugs. The investigation also shows that drugs originally developed to treat bipolar disorder and schizophrenia are now commonly used to treat symptoms of post-traumatic stress disorder, such as headaches, nightmares, nervousness and fits of anger.
Such ‘off-label’ use — prescribing medications to treat conditions for which the drugs were not formally approved by the FDA — is legal and even common. But experts say the lack of proof that these treatments work for other purposes, without fully understanding side effects, raises serious concerns about whether the treatments are safe and effective.”
Many military administrators have unabashed drug company links, like Dr. Matthew Friedman, former executive director of the Veterans Affairs’ National Center for PTSD,29 who admitted receiving AstraZeneca money in a video on the Center’s site a few years ago (a video since taken down) and served as Pfizer Visiting Professor while helming a government organization.30
Recently, the Annals of Internal Medicine ran another study looking at military suicides without finding an antidepressant role. The study’s editors at the Annals had links31 to Eli Lilly, Pfizer and Johnson & Johnson. Considering all the risks associated with antidepressants, it would be wise to use them as a very last resort. To learn more about safer treatment options, please see my previous article, “Supplements Proven Beneficial for Your Mental Health.”
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Brazil’s Ministry of Health has launched an investigation into the cluster of babies born with brain defects linked to the Zika virus, after an expected “explosion” of cases across the country did not occur.
The bulk of the cases of congenital Zika syndrome – fetal brain defects that sometimes cause microcephaly, or abnormally small skulls – remain clustered in the northeast region of the country where the phenomenon was first identified last October, the ministry says.
And that has epidemiologists and infectious disease experts asking what is going on: Is it Zika and another virus working together that damages the fetal brains? Is it Zika and an environmental factor? Or something about the women themselves whose fetuses are affected?
The research in Brazil won’t have conclusions for months, but will have implications across the Americas, where the Brazilian experience and the rapid spread of Zika has caused governments to take protective measures and even warn women to delay getting pregnant.
“We can see there is a kind of cluster in [part of] the northeast region with high prevalence and high severity, of miscarriage and congenital malformation that is really severe,” said Fatima Marinho, co-ordinator of epidemiological analysis and information at the ministry.
“But we didn’t find this in other states – even the [adjacent] states didn’t see the same situation as in the epicentre…. We were preparing for an explosion and it didn’t come.
“So we started to think that in this central area maybe more than Zika is causing this intensity and severity.”
A central theory the ministry is now exploring is whether co-infection with other viruses, such as dengue or chikungunya, is the factor. For example, does a mother’s previous (or simultaneous) infection with dengue, which is also ubiquitous in Brazil, mean that the Zika virus affects a fetus differently? Or is it other viruses?
“This is an area that was under attack by viruses: Some parts even had measles,” during the period when the bulk of the congenital Zika babies were conceived, Dr. Marinho said.
The ministry is also looking at social determinants, she said, because initial analysis makes it clear the women with affected fetuses have a clear “profile.” Some 77 per cent of them are black or mixed-race (the national figure is 52 per cent), and the great majority are poor. That’s surprising, she said, given that dengue, for example, carried by the same mosquito, infects people across social classes. Most of the mothers are young (between 14 and 24) whereas typically birth defects affect older women.
The World Health Organization is supporting research into co-factors. “Even though a causal link between Zika virus and congenital malformations has been conclusively demonstrated as published in international peer-reviewed scientific publications, other factors that may aggravate these conditions also require investigation,” said Sylvain Aldighieri, incident manager for Zika with the Pan American branch of the WHO.
“I totally agree some co-factors are likely involved,” said Eduardo Marques, a professor of infectious disease and microbiology at the University of Pittsburgh and scientific director of a program called Cura Zika. But it isn’t the cluster that convinces him: “It’s because not every woman exposed during pregnancy has a baby with the congenital effects.”
But not all epidemiologists concur: “I think it’s too early to say there is a disparity in the rate of microcephaly,” said Laura Rodrigues, a professor of infectious disease epidemiology at the London School of Hygiene and Tropical Medicine, who has been working on Brazil’s Zika epidemic since it was first identified. The epidemic is nearly a year behind in its spread in some other countries and perhaps other parts of Brazil, she said. “So maybe haven’t got to the peak. But that’s not to say we shouldn’t think about co-factors.”
Because the virus produces no symptoms in up to 80 per cent of people who get it, and only mild symptoms in many others, few people confirm Zika infection with laboratory tests, and so statistics of Zika cases are always estimates. The virus currently infecting Brazilians is a new, Asian strain of Zika, which was identified more than 60 years ago but never associated with congenital problems, or known to be sexually transmissible, as this strain is.
After Brazil, the next country that was expected to see the wave of congenital Zika was Colombia, which has the second-largest number of reported Zika cases. But of more than 12,000 pregnant Colombian women with Zika, only 21 have had fetuses or babies with the brain defects.
Dr. Marinho, with the ministry, said this reinforces her suspicions about the role of co-infection or other factors in Brazil. Dr. Marques said Colombia is only seeing the babies of women who were infected late in their pregnancies so far (because the virus season is about six months behind, further to the north) and the evidence is that the likelihood of damage by Zika is higher earlier in gestation – so those babies may yet come.
But Dr. Rodrigues had another explanation. “Now we know that in places where Zika comes the rate of abortion shoots up,” she said. “The feminist groups that will send pills by post to women … as a way of making up for the unfairness of the restrictive abortion laws, report an enormous increase in requests from Brazil and Latin America. I wouldn’t be surprised if when we look at cohorts in other counties, pregnancies disappear, and we can’t say if it was spontaneous or medical abortion.”
Researchers reported in the New England Journal of Medicine on July 28 that in Latin American countries where the new strain of Zika is spreading and abortion is illegal, there has been a huge spike in the number of requests to Women on Web, a Dutch-based organization which proves women with online consultations and then mails the drugs to induce a medical abortion. The increase over the rate of requests last year ranges from 38 per cent to 108 per cent in Brazil. (Brazilian authorities are now intercepting all deliveries to Brazilian women, the group said.)
On July 15, Adriana Melo, a fetal medicine specialist in the state of Paraiba who was the first to find Zika in the brains of affected babies, released research in which she and her co-authors report finding proteins of bovine viral diarrhea virus (BVDV), a cattle disease, in the brains of three fetuses with microcephaly from Paraiba whose brains also tested positive for RNA from the Zika virus. BVDV is known to cause serious birth defects in cows, but not to infect people. The findings were posted on BioArchive, a U.S.-based website for scientists to quickly share research findings on urgent matters, before peer review and publication. Their hypothesis is that Zika infection may weaken physiological barriers, so the cow virus that would not normally affect a human fetus can cause damage.
However other researchers are expressing skepticism of this theory – and Dr. Melo and her colleagues acknowledged the possibility that the BVDV they found was the result of sample contamination, because the virus is often found in fetal bovine serum, which is a reagent (a substance used in chemical analysis) frequently used in laboratories.
Dr. Marinho is at pains to make clear that the health ministry does not doubt that Zika is the primary cause of the fetal brain damage. (Brazilian doctors were quick to persuade the ministry of the link last year, but had a much longer job to convince the World Health Organization, which declared an emergency over microcephaly only in February.) Then conspiracy theories tore through the public in Brazil and beyond – that microcephaly was actually caused by a pesticide, or vaccines, or genetically modified mosquitoes – and she does not want to revive that debate.
“We know here Zika caused neurological damage – we have no doubt – but the question is how can we explain this situation in the epicentre that was not reproduced in other areas – in Colombia, and in other states in Brazil. A lot of pregnant women were infected and there were few cases of microcephaly or congenital malformation – it must be more than Zika itself,” she said. “We could be wrong of course but it is the responsibility of the Ministry of Health to investigate all possibilities.”
Beneath all of these theories lies a fundamental problem with data. Until this crisis, Brazil had very weak reporting of microcephaly, with rates in some areas reported as 1,000 times lower than in Europe even though researchers have every reason to believe that it occurred at roughly the same rates.
With the emergency declared, health workers suddenly erred in the wrong direction, overreporting microcephaly. Almost none of the women with affected babies had a serologically confirmed Zika diagnosis. Beyond that, Dr. Melo and her colleagues realized many of the worst-affected babies had completely normal looking skulls, and it was not until they showed neurological problems that they were reported as Zika-affected. She told The Globe in February that it was impossible to know how many had slipped through the net and were as yet undiagnosed. In addition, an unknown number of affected pregnancies ended in miscarriage.
“The current epidemiological info is very fragile, so how do we know, for example, that we didn’t have an explosion of cases in Rio in 2014 and we didn’t pick it up?” asked Dr. Marques.
The Asian strain of Zika hit French Polynesia in 2013 and researchers have gone back to retrospectively diagnose 17 cases of babies born with microcephaly in a total population of 275,000 people – but researchers hotly debate how useful that information is for indicating the likelihood of co-factors, since it’s retrospective and based on modelling. In addition, while Zika was not known to be related to fetal development problems at the time, abortion is legal in French Polynesia and women who were told their babies had brain defects could have terminated their pregnancies.
Brazil has 1,749 cases of confirmed congenital Zika syndrome so far, with 106 stillbirths and deaths. Dr. Marinho said it will be months before the ministry has solid data to confirm that the cases are clustered and there are co-factors involved, let alone what they are, and meanwhile congenital Zika remains a real threat: Paraiba is now seeing a second wave of cases. “But this could be good news, for other areas of Brazil, and other countries,” she said.