Published: Sat, 29 Apr 2017 00:00:00 -0400
Last Build Date: Sat, 29 Apr 2017 07:01:26 -0400
Fri, 21 Apr 2017 16:00:00 -0400The right answer is: No. Why bring this issue up? HBO will be showing a movie based on the 2010 bestseller The Immortal Life of Henrietta Lacks tomorrow starring Oprah Winfrey. In 1951, black Baltimorean Henrietta Lacks had surgery to remove a cervical cancer tumor. Her physician took some cells from the tumor which he turned into the first immortal line human cell line. The HeLa cell line has been subsequently used in thousands of biomedical research projects. Lacks died later that year of her cancer, and her family was not told about the HeLa cell line. One of the central themes of the book was whether or not Lacks' physician should have asked for consent and provided compensation for the use of her cells. Spurred by the controversy engendered by the book, the U.S. Department of Health and Human Services proposed revisions to the Common Rule that protects people who volunteer for federally funded research studies. The proposed revisions would have substantially increased the burden on researchers with regard to obtaining consent from patients for the subsequent use of their medical wastes, uh, biospecimens. I am happy to report that in their op/ed, "Science Needs Your Cells," in today's New York Times two bioethicists agree with me that such requirements are largely useless and would substantially slow down medical progress. From the op/ed: First, no one is taking biospecimens from patients' bodies without their permission. Patients have consented to the clinical procedure as important to their medical care. What harm could come from using leftover materials, which would otherwise be thrown away, for research? Perhaps we should be concerned about risks to a patient's privacy, but that is why we remove the identifying information. Although researchers have shown that it is possible to "de-anonymize" specimens — using clues to link them back to individuals — there have been no reports of anyone doing this for nefarious reasons. And even if there were, the answer would be to sanction the culprit through fines or criminal charges, not to make it harder for researchers to get these samples in the first place. What is left, then, is our claim to autonomy: Many of us intuitively feel we should be able to control how biospecimens derived from our bodies are used. But leftover biospecimens are just medical waste to most of us, as we lack the expertise to imbue them with scientific value. Nor have we done anything to make them valuable, other than being born with a particular genetic variant or afflicted with a particular malignancy. This is why calls to pay patients are misplaced. In addition, unlike HeLa, in which one patient's biospecimens led to dramatic advancements, most developments come from studying materials from many patients — each biospecimen contributes only marginally to the result. These relatively weak claims to control and compensation do not justify the demands more restrictions would place on biospecimen research. Hindering this research is worrisome because its benefits are so great. Among many examples, they include the identification of mutations in tumors (lung, skin and others) that can be targeted with drugs that markedly improve quality of life and survival. Requiring consent might not seem like a big deal. But it is. Consent might require tracking patients down later, whenever a study is proposed, which can be difficult or impossible. Alternately, it might involve asking patients to agree generally to any future research at the time blood is drawn or a biopsy is taken. Either way, it can be a costly, bureaucratic headache. Which patients said yes, which said no, and to what, exactly? They are correct. And the good news is that most the proposed consent revisions to the Common Rule have been dropped. With regard to compensation, in her Times' interview about the movie Oprah Winfrey notes that some Lacks family members had sought a payment of $10 million from her and HBO.[...]
Fri, 31 Mar 2017 13:30:00 -0400"In this world nothing can be said to be certain, except death and taxes," quipped Benjamin Franklin. For now both remain inevitable, but two exciting new studies suggest that the grim reaper might be put off by novel treatments that can slow and even reverse aging. Peter de Keizer, a molecular geneticist at Erasmus University, reports in the journal Cell that he and his colleagues have developed a technique that kills off senescent cells. Our bodies have two ways of preventing damaged cells from becoming cancerous: kill them off, or cause them to cease replication and thus become senescent. Senescent cells accumulate as we grow older, secreting inflammatory substances that harm neighboring cells and contribute to many age-related diseases, including atherosclerorsis and diabetes. De Keizer and his colleagues have developed a treatment in mice that selectively kills senescent cells while leaving healthy normal cells alone. They discovered that old or damaged cells become senescent rather than die when the FOXO4 protein binds to the tumor suppressor gene p53. They have designed another protein that interferes with the ability of FOXO4 to halt p53 from causing cells to die. De Keizer's team administered the new protein to both fast-aging and normally aged mice. The treatment worked as they had hoped, jumpstarting the ability of p53 to make senescent cells commit suicide. Eliminating senescent cells restored stamina, fur density, and kidney function in both strains of mice. The researchers report that they are continuing to study the rodents to see if the treatment extends their lifespans. They plan to try the treatment to stop brain cancer in human beings, but the ultimate goal is to treat aging as a disease. "Maybe when you get to 65 you'll go every five years for your anti-senescence shot in the clinic. You'll go for your rejuvenation shot," de Keizer told the Tech Times. In the same week, another group of Harvard researchers led by molecular biologist David Sinclair reported in Science about experiments in mice that thwart DNA damage associated with aging and exposure to radiation. As we age, our cells lose their ability to repair the damage to the DNA that makes up our genes. The repair process is orchestrated by the SIRT1 and PARP1 proteins. Both proteins consume the ubiquitous coenzyme nicotinamide adenine dinucleotide (NAD) to operate. As we grow older, the amount of NAD in our cells declines, thus allowing another protein, DBC1, to inhibit the DNA repair activity of both SIRT1 and PARP1. In their new research, the scientists fed the NAD precursor nicotinamide mononucleotide (NMN) to mice that were equivalent in age to an 80-year-old person. They also gave it to mice whose DNA had been damaged by radiation. The compound boosted NAD back to youthful levels and restored their ability to repair the DNA damage in both the old and irradiated cells. Sinclair said, "The cells of the old mice were indistinguishable from the young mice, after just one week of treatment." In addition, dosing astronauts traveling to Mars with NMN could counteract the damage that radiation in deep space would cause them. In an earlier experiment by Sinclair and his associates, the muscles of two-year-old mice fed NMN resembled those of six-month-old mice with respect to insulin resistance, inflammation, muscle wasting, and other important markers. Sinclair says that his group plans to launch human NMN trials in the next six months. Other groups have already started and completed safety trials of other NAD precursors in human beings. Leonard Guarente, director of the Massachusetts Institute of Technology's Glenn Laboratory for the Science of Aging, reported the results in December of a clinical trial involving 120 people who took the NAD precursor nicotinimide riboside (NR). The trial found that subjects experienced no serious adverse events. The participants ranged in age from 60 to 80 years old and took it for eight weeks. The researchers report that NAD "levels increased from baseline in whole blood by an average o[...]
Fri, 31 Mar 2017 13:30:00 -0400
(image) "In this world nothing can be said to be certain, except death and taxes," quipped Benjamin Franklin. For now both remain inevitable, but two exciting new studies suggest that the grim reaper might be put off by novel treatments that can slow and even reverse aging.
Senescent cells accumulate as we grow older, secreting inflammatory substances that harm neighboring cells and contribute to many age-related diseases, including atherosclerorsis and diabetes. Researchers associated with Erasmus University report that they have developed a compound that selectively kills off senescent cells while leaving healthy ones alone. Eliminating senescent cells restored stamina, fur density, and kidney function in aged mice. The researchers report that they are continuing to study the rodents to see if the treatment extends their lifespans. "Maybe when you get to 65 you'll go every five years for your anti-senescence shot in the clinic. You'll go for your rejuvenation shot," speculated one researcher.
As we age, our cells lose their ability to repair the damage to the DNA that makes up our genes. Another team of researchers associated with Harvard University are reporting experiments that increase levels of a compound that restores DNA repair activity back to youthful levels.
Wed, 15 Mar 2017 12:55:00 -0400
"The U.S. [health care system] is what you get when you let government run rampant," says Michael F. Cannon, who's the Cato Institute's director of health policy studies. "The government controls half of our health care spending directly and the other half indirectly." He elaborated:
The government tightly controls who can practice medicine, what education they must have, what tasks they can perform, where they can practice medicine, who can open a medical facility, who can purchase expensive medical equipment, where we can purchase our medical insurance, what our insurance covers, the prices we pay for insurance, how we obtain health care in retirement, what treatments doctors can describe, what manufacturers can say about those treatments and their products, the organization structure of health care providers, how health providers get paid, how much they get paid, how much we spend on health care, [and] how we help the poor obtain health care.
(image) Would Americans be better off if the government pulled back and let markets function? That was the topic of a debate held Monday night at the Soho Forum, a monthly Oxford-style debate series that "features topics of special interest to libertarians" and "aims to enhance social and professional ties within the New York City libertarian community." (An archive of past Soho Forum events.)
Cannon's debating partner was The Huffington Post's Jonathan Cohn, author of the 2007 book, Sick: The Untold Story of America's Health Care Crisis—and the People Who Pay the Price.
Cohn and Cannon debated the following resolution: "A market system for medical care would save more people from suffering inadequate care than any other system." At the beginning of the event, attendees voted "yes," "no," or "undecided." After Cannon and Cohn had their say, the audience voted again.
Cohn won the debate, convincing two percent of "yes" votes and 16 percent of the undecideds to switch to his side. The results are here.
Listen to the debate on SoundCloud below. Better yet, subscribe to the Reason podcast at iTunes.
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Wed, 22 Feb 2017 08:00:00 -0500Last week the U.S. Court of Appeals for the 11th Circuit overturned a censorious Florida law that tried to stop doctors from pestering their patients about guns, sacrificing the First Amendment in the name of protecting the Second. Such laws, which the National Rifle Association supports, show how fake rights—in this case, an overbroad understanding of the right to armed self-defense—endanger real ones. Florida's Firearm Owners' Privacy Act, enacted in 2011, was a response to complaints that pediatricians and family practitioners had become excessively nosy about guns in the homes of their patients. The American Medical Association, the American Academy of Pediatrics, and the American Academy of Family Physicians encourage their members to ask parents about guns, treating them as hazards analogous to alcohol, swimming pools, and poisonous household chemicals. Sometimes gun owners object to such inquiries, especially if they seem to be colored by a moralistic anti-gun ideology. The 11th Circuit's decision describes half a dozen examples that influenced Florida's legislators: A pediatrician in Ocala had reportedly told a mother that she would have to find a new physician for her child due to her refusal to disclose information about firearm ownership in the family home. A state representative said that his daughter's pediatrician inquired if he owned a firearm, and then asked him to remove the firearm from the home. An email described how a mother "was separated from her children while medical personnel...interrogated" them about firearm ownership and put information about such ownership in their medical records. One doctor refused to treat a child because he wanted to know if there were firearms in the home. A patient, according to a state senator, was told that disclosing firearm ownership was a Medicaid requirement. And another patient was informed that Medicaid does not pay for care if patients refuse to answer firearm-ownership questions. A representative of the National Rifle Association reported that a child would not be examined if the parent refused to answer questions about firearms in the home. Assuming these accounts are accurate, the behavior of these doctors may have been unreasonable or even (when they misrepresented Medicaid requirements) unethical. But their requests for information about guns were not unconstitutional, since the Second Amendment applies only to the government. The law passed in response to these anecdotes nevertheless purported to protect the Second Amendment rights of Floridians by regulating what doctors say to their patients. As the 11th Circuit notes, that makes no sense (citations omitted, emphasis added): There was no evidence whatsoever before the Florida Legislature that any doctors or medical professionals have taken away patients' firearms or otherwise infringed on patients' Second Amendment rights. This evidentiary void is not surprising because doctors and medical professionals, as private actors, do not have any authority (legal or otherwise) to restrict the ownership or possession of firearms by patients (or by anyone else for that matter). The Second Amendment right to own and possess firearms does not preclude questions about, commentary on, or criticism for the exercise of that right. So, as the district court aptly noted, there is no actual conflict between the First Amendment rights of doctors and medical professionals and the Second Amendment rights of patients that justifies [the law's] speaker-focused and content-based restrictions on speech. In addition to prohibiting doctors from discriminating against gun owners (a provision the appeals court upheld), the Firearm Owners' Privacy Act forbade them to request or record information about guns unless it is "relevant to the patient's medical care or safety, or the safety of others"—a standard that rules out routine inquiries about firearms. The law also instructed doctors to "refrain from unnecessarily[...]
Thu, 12 Jan 2017 04:00:00 -0500
(image) Former Dayton, Ohio, police officer Ryan Meno has pleaded guilty to stealing prescription pain medicine from a home that he went to to respond to a possible break-in. He faces up to 30 months in prison.
Wed, 11 Jan 2017 12:45:00 -0500The U.S. homicide rate peaked in 1980 at 10.2 per 100,000 Americans and the number of annual homicides rose to 24,703 in 1991. Since then U.S. homicide rates have been falling and reached 4.5 per 100,000 in 2014 (a rate not seen since the 1950s) and an annual toll of 14,249. Both the rate and number of murders ticked up in 2015 to 5 per 100,000 and 15,809 respectively. Lots of research has been devoted to trying to figure out why homicide rates fell over the past couple of decades. Some researchers focused on higher incarceration rates; others on more effective policing; still others cited the aging population; and some attributed lower homicide rates to better emergency medicine. Given the fact that the data on criminally inflicted gunshot injuries is not collected comprehensively, this this latter claim has been challenged. A fascinating new working paper, "Dial 911 for Murder," by George Mason University economists Thomas Stratmann and David Chandler Thomas argue that advances in the 911 emergency response system over time, combined with the advent of cell phones have contributed significantly to the lower U.S. murder rate because victims are receiving emergency medical care ever more speedily. The argument is that victims of violent gun firearms attacks are increasingly likely to be saved from death thus converting what would have been homicides into aggravated assaults. In addition, they find the establishment of 911 systems initially increased reporting of aggravated assaults and that the subsequent proliferation of cell phones seems to have had a deterrent effect on such assaults. The initial 911 system devised in 1968 connected to an operator who then transferred the call to the police, fire, and ambulance services as appropriate. In the late 1970s, dedicated 911 call centers were established with monitors that displayed the home number and address of callers and from which emergency services were dispatched by trained personnel. Now GPS 911 is rolling out enabling dispatchers to pinpoint callers and dispatch services to people using cell phones. The researchers suggest that "when potential violent street offenders know that cell phone users have a quick way to reach the police, via GPS 911, their incentive to commit a crime decreases." The researchers account for the lethality of weapons over time, socioeconomic changes, improvements in trauma care, and so forth. Once they've parsed the data, they report: While the level of violent crimes, measured as aggravated assaults, is 219 percentage points higher in 2014 than in 1964, homicides in 2014 are eight percentage points lower than in 1964. In this paper, we find support for the hypothesis that the introduction of 911 services explains much of the decrease in homicide rates. Moreover, the introduction of 911 provides an explanation for the divergence between aggravated assault and homicide rates that started in the early 1970s. ...The empirical results in this paper indicate that reductions in emergency response times played a significant role in reducing U.S. homicides over the past 45 years. .... The reported 911 effects are quantitatively important, suggesting more than a 34 percent to 56 percent decrease in homicides that can be attributed to the 911 systems and associated reductions in response times. One simple approach to illustrate the benefits of 911 is to use our estimates to quantify the lives saved by 911 innovations. Such an exercise shows that in 2014, without 911 emergency services, the number of homicides in our sample cities would have been more than 13,000 homicides, instead of the reported 5,872. Citing the trends in Mobile, Alabama they report that the introduction of basic 911 coincided with an immediate 29 percent drop in that city's homicide rate which continued to fall in the following years. However, after the introduction of enhanced 911 in the late 1980s, the city's homici[...]
Fri, 06 Jan 2017 11:30:00 -0500CORRECTION: The data in this item are correct, but out of date. I erroneously reported these as being the latest figures, but actually the American Cancer Society has issued Cancer Statistics 2017. I have now reported as a correction to this post the new data here. The good news is that trends in both cancer death rates and incidence are even better in 2017. I hope that readers were not unduly confused by my error. The cancer death rate has dropped by 23 percent since 1991, translating to more than 1.7 million deaths averted through 2012, according the latest Cancer Statistics 2016 report from the American Cancer Society (ACS). Cancer incidence - percent of folks who get cancer each year - has also fallen since the early 1990s. The falling incidence trend continues in the latest report for men, declining by 3.1 percent year between 2009 and 2012. However, the cancer incidence rate remained steady for women over that period. A lot the falling rate of cancer incidence can be chalked up to less lung cancer as fewer people smoke and more colonoscopies which prevent colorectal cancer. In addition, the report notes that the recent rapid decline in prostate cancer diagnoses accounts for about one-half of the total incidence decrease in men. The reduction in prostate cancer diagnosis is largely the result new guidelines from the U.S. Preventive Services Task Force against routine screening with the PSA test because of growing concerns about high rates of overdiagnosis. It is worth noting that that contrary to the USPST's blanket recommendation, the American Cancer Society urges men to talk with their physicians about the risks and benefits and decide for themselves whether they want the screening test. The new ACS also notes that thyroid cancer rates appear to be increasing largely because the advent of more sensitive screening tests that identify lots of cancers in people over age 50 that are not clinically relevant; about 50 percent in women and 40 percent in men. The report futher notes: The lifetime probability of being diagnosed with an invasive cancer is higher for men (42%) than for women (38%). Reasons for increased susceptibility in men are not well understood, but to some extent reflect differences in environmental exposures, endogenous hormones, and probably complex interactions between these influences. Adult height, which is determined by genetics and childhood nutrition, is positively associated with cancer incidence and death in both men and women, and has been estimated to account for one-third of the sex differences in cancer risk. Being male and standing at 6 feet 5 inches, I'm at higher risk, but the mortality trends give me some scope for optimism. After all, at a conference in 2015, Dr. D. Gary Gilliland, president and director of Fred Hutchinson Cancer Research Center, declared, "It's actually plausible that in 10 years we'll have curative therapies for most if not all human cancers." With regard to mortality trends, the ACS reports: The overall cancer death rate rose during most of the 20th century, largely driven by rapid increases in lung cancer deaths among men as a consequence of the tobacco epidemic. Steady reductions in smoking, as well as advances in cancer prevention, early detection, and treatment, have resulted in a 23% drop in the cancer death rate, from a peak of 215.1 (per 100,000 population) in 1991 to 166.4 in 2012. The decline, which is larger in men (28% since 1990) than in women (19% since 1991), translates into the avoidance of approximately 1,711,300 cancer deaths (1,199,200 in men and 512,100 in women) that would have occurred if peak rates had persisted. One more takeaway: There is no rising cancer epidemic; much less one that can be attributed to modern technologies like cell phones, genetically modified crops and trace exposures to synthetic chemicals.[...]
Thu, 15 Dec 2016 14:30:00 -0500
(image) On Tuesday, a baby was born. NBD. Happens all the time.
This baby, though, is the first person ever made with an egg from an ovary that had been removed from the mother when she was pre-pubescent.
As a 9-year-old child, the BBC reports, Moaza Al Matrooshi had aggressive chemotherapy followed by a bone marrow transplant from her brother to treat a potentially fatal blood disorder, which did a number on her remaining ovary—so much so that as a young adult she had started to go into early menopause.
So doctors fetched her ovarysicle from cryopreservation, where it had been chillin' in some liquid nitrogen at minus 196C for 15 years. They sliced off four slivers of tissue and implanted them into the busted ovary, plus one more into the side of her uterus.
And darned if she didn't start ovulating. To maximize the odds of success, docs plucked those eggs out (they got eight) mixed them with her husband's sperm in a petri dish to produce embryos (they got three) and implanted two of those embryos via IVF. Thirty-eight weeks later, give or take, one baby was born.
Al Matrooshi hails from Dubai, her ovary was frozen in Leeds, her cancer was treated in London, and the thawed tissue was implanted in Denmark. Then back to London for the baby's birth at the American-operated Portland private hospital.*
The fertility math and medical geography sound almost unbelievable, and indeed when the ovary was initially frozen this scenario was pure science fiction; Al Matrooshi's own mother suggested saving the ovary as a crazy long shot.
But this baby's not a miracle. He's the product of a bunch of individuals' inspiration and hard work and risk-taking and study and travel and pain and a crapton of money. All the factors came together now the world gets a real live bonus human. Well done, everybody.
Al Matrooshi has another embryo on ice, technically the twin of her newborn son, and is already thinking about kid number two.
*Edited to clarify a confusing geographical reference to Portland.
Fri, 02 Dec 2016 13:30:00 -0500Emma Morano turned 117 on Tuesday. The Italian woman is, as far as we know, the oldest person in the world and the only living person who was born in the 1800s. The secret for her longevity? Eating three raw eggs a day and being single since 1938. The person known to have lived the longest ever was Jeanne Calment, who died in 1997 at 122 years of age. In October, Nature published an article, "Evidence for a limit to human lifespan," by three researchers associated with the Albert Einstein College of Medicine in the Bronx. Noting that the longest known lifespan has not increased since the 1990s, they argue that there is a fundamental limit to human longevity. The occasional outlier aside, they think that limit is about 115 years. Maybe, maybe not. In the 21st century, almost everything that kills people, except for accidents and other unintentional causes of death, has been classified as a disease. Aging kills, so it's past time to declare it a disease too and seek cures for it. In 2015, a group of European gerontologists persuasively argued for doing just that. They rejected the common fatalistic notion that aging "constitutes a natural and universal process, while diseases are seen as deviations from the normal state." A century ago osteoporosis, rheumatoid arthritis, high blood pressure, and senility were considered part of normal aging, but now they are classified as diseases and treated. "There is no disputing the fact that aging is a 'harmful abnormality of bodily structure and function,'" they note. "What is becoming increasingly clear is that aging also has specific causes, each of which can be reduced to a cellular and molecular level, and recognizable signs and symptoms." So why do people age and die? Basically, because of bad chemistry. People get cancer when chemical signals go haywire enabling tumors to grow. Heart attacks and strokes occur when chemical garbage accumulates in arteries and chemical glitches no longer prevent blood cells from agglomerating into dangerous clumps. The proliferation of chemical errors inside our bodies' cells eventually causes them to shut down and emit inflammatory chemicals that damage still healthy cells. Infectious diseases are essentially invasions of bad chemicals that arouse the chemicals comprising our immune systems to try and (too often) fail to destroy them. Also in 2015, another group of European researchers pointed out that we've been identifying a lot of biomarkers for detecting the bad chemical changes in tissues and cells before they produce symptoms associated with aging. Such biomarkers enable pharmaceutical companies and physicians to discover and deploy treatments that correct cellular and molecular malfunctions and nudge our bodies' chemistry back toward optimal functioning. As a benchmark, the researchers propose the adoption of an "ideal norm" of health against which to measure anti-aging therapies. "One approach to address this challenge is to assume an 'ideal' disease-free physiological state at a certain age, for example, 25 years of age, and develop a set of interventions to keep the patients as close to that state as possible," they suggest. Most people's body chemistry is at its best when they are in their mid-twenties. In fact, Americans between ages 15 and 24 are nearly 500 times less likely to die of heart disease, 100 times less likely to die of cancer, and 230 times less likely die of influenza and pneumonia than people over the age of 65 years. For lots of us who are no longer in our twenties, television talk show host Dick Cavett summed it up well: "I don't feel old. I feel like a young man that has something wrong with him." Meanwhile, lots of progress has been made toward ameliorating many of the diseases whose prevalence increases with aging. For example, the five-year survival rate for cancer patien[...]
Fri, 02 Dec 2016 13:30:00 -0500
(image) Emma Morano turned 117 on Tuesday. The Italian woman is, as far as we know, the oldest person in the world and the only living person who was born in the 1800s. The secret for her longevity? Eating three raw eggs a day and being single since 1938. The person known to have lived the longest ever was Jeanne Calment, who died in 1997 at 122 years of age.
In October, Nature published an article, "Evidence for a limit to human lifespan," by three researchers associated with the Albert Einstein College of Medicine in the Bronx. Noting that the longest known lifespan has not increased since the 1990s, they argue that there is a fundamental limit to human longevity. The occasional outlier aside, they think that limit is about 115 years.
Maybe, maybe not. In the 21st century, almost everything that kills people, except for accidents and other unintentional causes of death, has been classified as a disease. Aging kills, so it's past time to declare it a disease too and seek cures for it.
Thu, 01 Dec 2016 08:45:00 -0500Two studies published today in the journal Psychopharmacology indicate that a single dose of psilocybin, the main active ingredient in "magic mushrooms," has large and lasting effects on anxiety and depression in cancer patients. The research, which is consistent with earlier studies suggesting the psychological benefits of psilocybin and LSD for people who are gravely ill, is an important step in the medical and legal rehabilitation of a drug that has been banned since 1970. Both studies used a randomized, double-blind, crossover design in which subjects either took psilocybin in the first session and a placebo in the second or vice versa. To help maintain the mystery of who got what when, both studies used active placebos: niacin in one case and a low dose of psilocybin in the other. One study, conducted by researchers at New York University, involved 29 patients who received either psilocybin or niacin in conjunction with psychotherapy. "For each of the six primary outcome measures," NYU psychiatrist Stephen Ross and his co-authors report, "there were significant differences between the experimental and control groups (prior to the crossover at 7 weeks post-dose 1) with the psilocybin group (compared to the active control) demonstrating immediate, substantial, and sustained (up to 7 weeks post-dosing) clinical benefits in terms of reduction of anxiety and depression symptoms. The magnitude of differences between the psilocybin and control groups...was large across the primary outcome measures, assessed at 1 day/2 weeks/6 weeks/7 weeks post-dose 1." These improvements persisted for at least six-and-a-half months after the psilocybin dose, when the final follow-up was completed. "Single moderate-dose psilocybin, in conjunction with psychotherapy, produced rapid, robust, and sustained clinical benefits in terms of reduction of anxiety and depression in patients with life-threatening cancer," Ross et al. write. "This pharmacological finding is novel in psychiatry in terms of a single dose of a medication leading to immediate anti-depressant and anxiolytic effects with enduring...clinical benefits." The researchers conclude that "the psilocybin-induced mystical experience mediated the anxiolytic and anti-depressant effects of psilocybin," since the intensity of that experience was correlated with the magnitude of the effects. "It is unclear from the data whether the sustained benefits in clinical outcomes were due to psilocybin alone or some interactive effect of psilocybin plus the targeted psychotherapy," Ross et al. say. "Future research would be necessary to separate out the various therapeutic contributions of psilocybin versus psychotherapy." But the other psilocybin study reported in Psychopharmacology today, which was conducted by researchers at Johns Hopkins University and involved 51 cancer patients, shows that the psychedelic can have similar effects without psychotherapy. Johns Hopkins psychiatrist Roland Griffiths and his colleagues used a design similar to the NUY study's (two sessions, one with a high dose of psilocybin and one with a very low dose) but skipped the psychotherapy. "When administered under psychologically supportive, double-blind conditions, a single dose of psilocybin produced substantial and enduring decreases in depressed mood and anxiety along with increases in quality of life and decreases in death anxiety in patients with a life-threatening cancer diagnosis," Griffiths et al. report. "Ratings by patients themselves, clinicians, and community observers suggested these effects endured at least 6 months. The overall rate of clinical response at 6 months on clinician-rated depression and anxiety was 78% and 83%, respectively." These striking results inspired fear as well as hope. In an interview [...]
Wed, 30 Nov 2016 08:15:00 -0500
(image) More than three decades after the Drug Enforcement Administration banned MDMA, federal regulators have approved research that could make the compound legally available as a psychotherapeutic catalyst by 2021. The New York Times reports that researchers studying MDMA as a treatment for posttraumatic stress disorder (PTSD) yesterday received permission from the Food and Drug Administration for Phase 3 clinical trials, the final step before approval of a new medicine.
The Multidisciplinary Association for Psychedelic Studies (MAPS), which is sponsoring the research, funded six Phase 2 studies involving a total of 130 subjects. Hundreds of subjects will participate in the next phase.
In one Phase 2 study, scores on the Clinician-Administered PTSD Scale fell by almost two-thirds, on average, among 19 subjects who underwent MDMA-assisted psychotherapy. A follow-up study found that the improvements generally persisted an average of almost four years later.
"It changed my life," an Iraq and Afghanistan veteran who participated in one of the Phase 2 trials told the Times. "It allowed me to see my trauma without fear or hesitation and finally process things and move forward." Another subject, a firefighter traumatized by "years of responding to gory accidents," said MDMA-assisted psychotherapy "gave me my life back."
The psychotherapeutic potential of MDMA, which enhances empathy, reduces fear, and encourages openness, was apparent back in the late 1970s and early '80s, when the drug gained a following among psychiatrists. But once it was dubbed Ecstasy and became popular as a party drug, its fate was sealed. Like marijuana, LSD, and psilocybin, it has only recently re-emerged as a subject of legitimate medical research.
Reason TV covers the MAPS-sponsored MDMA research:
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Wed, 16 Nov 2016 09:10:00 -0500
(image) Last March a panel of experts organized by The Lancet condemned the war on drugs and recommended that countries "move gradually towards regulated drug markets." This week another esteemed British medical journal, The BMJ, followed suit, urging governments to "investigate more effective alternatives to criminalisation of drug use and supply."
The BMJ editorial notes that consumption of psychoactive substances is an ancient and persistent aspect of human behavior and that attempts to suppress it have had horrendous consequences, including crime driven by artificially high drug prices, promotion of blood-borne diseases, deaths linked to unpredictable potency and unreliable quality, and "appalling violence" in countries such as Mexico and the Philippines. "Too often the war on drugs plays out as a war on the millions of people who use drugs," the editors say, "and disproportionately on people who are poor or from ethnic minorities and on women."
In response to these costs, says The BMJ, "many countries have removed criminal penalties for personal drug possession," while "jurisdictions such as Canada, Uruguay, and several US states, now including California, have gone further, to allow regulated non-medical cannabis markets, retaking control of supply from organised crime." Because doctors "have ethical responsibilities to champion individual and public health, human rights, and dignity and to speak out where health and humanity are being systemically degraded," the editors argue, they "should use their authority to lead calls for pragmatic reform informed by science and ethics."
Addendum: Stephen Rolles, a senior analyst at the Transform Drug Policy Foundation in the U.K., notes that BMJ Editor in Chief Fiona Godlee signaled her support for drug legalization back in 2010, when Rolles wrote a antiprohibition essay for the journal. "He says, and I agree, that we must regulate drug use, not criminalise it," Godlee wrote at the time.
Thu, 13 Oct 2016 08:30:00 -0400The Drug Enforcement Administration's decision to withdraw its ban on kratom, a pain-relieving leaf from Southeast Asia, underlines the arbitrariness of the federal government's pharmacological taboos, which are based on undefined terms subjectively interpreted by bureaucrats with broad discretion to decide which substances Americans may ingest. The DEA's backtracking was prompted by complaints from kratom consumers, the companies that serve them, researchers who study the drug, and members of Congress. But despite the agency's newfound interest in public input on the question of kratom's legal status, it seems likely that we will end up with the same prohibitory result after a somewhat more elaborate process of post hoc rationalization. When the DEA announced at the end of August that it was temporarily placing kratom's main active ingredients in Schedule I, the most restrictive category under the Controlled Substances Act (CSA), it declared that a ban was "necessary to avoid an imminent hazard to the public safety." When the ban did not take effect on September 30 as expected, DEA spokesman Russell Baer assured Washington Post drug policy blogger Christopher Ingraham that "it's not a matter of if—it's simply a matter of when, in terms of DEA publishing the final order to temporarily schedule kratom." Since Acting DEA Administrator Chuck Rosenberg "has determined that kratom represents an imminent hazard to public safety," Baer said, "I have a sense that publishing our final order will be sooner as opposed to later." Rosenberg's determination was based on an unpersuasive, weakly supported analysis that dismissed kratom's benefits and exaggerated its hazards. Critics pointed out that the DEA's emergency scheduling authority, which Congress approved in 1984 at the agency's behest, was aimed at dangerous new synthetic drugs that might cause many injuries and deaths during the time required by the standard scheduling process. Here is how then-DEA Administrator Francis Mullen explained his understanding of "imminent hazard to the public safety" in a letter to legislators: The "imminent hazard" implies a need for immediate response to a drug trafficking and abuse situation that has occurred with such rapidity and with insufficient warning that normal control mechanisms would result in a large number of deaths and injuries or the continuance of an uncontrolled trafficking situation....The burden would be on the Government to prove that such an urgency exists and that the public safety would be jeopardized during the period that a drug would remain uncontrolled during routine scheduling action. As examples of substances that would be covered by the new provision, Mullen cited "newly synthesized drugs or uncontrolled analogs of existing drugs such as PCP and fentanyl," which "can cause widespread deaths and injuries in a very short period of time following their synthesis." Kratom, a "minimally toxic" natural substance that humans have used for centuries with little evidence of serious harm except in exreme cases, hardly fits that description. "The use of this emergency authority for a natural substance is unprecedented," noted Sen. Orrin Hatch (R-Utah) in a September 29 letter to Rosenberg. Whatever legislators may have had in mind when they created this prohibition shortcut, they did not define "imminent hazard to the public safety." The CSA says only that the attorney general (who has delegated his scheduling authority to the DEA) should consider a substance's "history and current pattern of abuse," "the scope, duration, and significance of abuse," and "what, if any, risk there is to the public health." That formulation leaves bureaucrats like Ro[...]