Published: Sat, 10 Dec 2016 00:00:00 -0500
Last Build Date: Sat, 10 Dec 2016 11:38:15 -0500
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 patients in 1975 was 50 percent; today it is about 68 percent. The annual rates of heart disease and strokes in the U.S. have fallen from 500 and 130 per 100,000 respectively in 1970 to about 175 and 35 per 100,000 today. Since 1999, the influenza and [...]
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 with The New York Times, William Breitbart, chairman of the psychiatry department at Memorial Sloan-Kettering Cancer Center, worried that improving the lives of cancer patients might be just the first step. "Medical marijuana got its foot in the [...]
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 Rosenberg free to describe any uncontrolled psychoactive substance, no matter how favorable its risk-to-benefit ratio, as "an imminent hazard to the public safety." The unscientific nature of that determination is clear from the fact that the DEA h[...]
Wed, 05 Oct 2016 12:08:00 -0400
How best to memorialize deceased loved ones is a question all families must ask themselves. For the most part, the answer is a conventional tombstone or urn. Now however those left behind have a new way to remember relatives in the form of DNA preservation.
DNA Memorial is a Canadian company that offers its customers a unique opportunity to save the genetic information of their dearly departed through their own special DNA preservation process.
How it works is quite simple: A customer, generally through a funeral home, will collect a DNA sample from the saliva or hair of the deceased on a cotton swab. That sample is then shipped to DNA Memorial, where the DNA is extracted, purified and then bound in a special chemical process to a silica-based substrate. The end result is a white powder of the deceased's genetic information that can be safely stored in the home at room temperature, preserving their unique genetic blueprint indefinitely.
Though this might sound strange to those more accustomed to burial or cremation, DNA preservation serves a number of unique purposes for relatives of the deceased.
Neal Esau, the company's co-founder and operations manager, tells Reason that many of their initial customers were interested in preserving DNA in order to trace their ancestry, for which having the exact genetic blueprint of one's immediate predecessor is quite useful. For a few this interest was more than just historical; the company has apparently performed a number of post-mortem paternity tests.
Those more interested in the sentimental side of things have themselves been drawn to DNA Memorial's line of jewelry and glassware, which is crafted with the DNA of whoever is to be memorialized
Great as these uses are, says Esau, the real benefits of DNA preservation come from its medical applications. Being able to provide a more a complete picture of a patient's genetic background enables his or her doctor to better test for and treat genetic diseases. And as the field of genetic science develops, it is hoped that the uses of DNA preservation will develop along with it, allowing medical professionals to more precisely trace mutations in populations or to create individually designed medical treatments tailored to one's specific genetic background.
Despite this being a new idea in an admittedly conservative field, Esau says DNA Memorial's services are proving quite popular. Having only started in 2014, the company now works with hundreds of funeral homes all across the U.S., U.K., and Canada, as well as with a single location in Israel.
And as the practice gains more mainstream exposure, the folks at DNA Memorial envision a number of new potential services, from launching DNA vials into space to storing it in ink for tattoos. That last one could give the classic mom-heart design some added significance.
Update 10/10: The spelling of Mr. Esau's name as been corrected.
Wed, 05 Oct 2016 00:01:00 -0400After the Drug Enforcement Administration (DEA) announced an "emergency" ban on kratom at the end of August, a spokesman for the agency said "our goal is to make sure this is available." The spokesman, Melvin Patterson, also told The Washington Post kratom does not belong in Schedule I of the Controlled Substances Act, the law's most restrictive category, even though that is where the DEA had just put it. Patterson added that kratom, which the DEA says has "no currently accepted medical use," is "at a point where it needs to be recognized as medicine." Confused? You're not alone. The DEA's ban on kratom, a pain-relieving leaf from Southeast Asia, shows how blithely and arbitrarily the government interferes with our freedom to control our own brains and bloodstreams. Kratom, which acts as a stimulant or a sedative, depending on the dose, has been used for centuries in countries such as Thailand, Malaysia, and Indonesia to ease pain, boost work performance, and wean people from opiate addiction. In recent years the drug has gained a following in the United States, sold by online merchants and head shops as an herbal medicine, dietary supplement, or legal high. That situation offended the DEA, which noted in the explanation of its ban that kratom had never been approved by the government for any use. If a psychoactive substance is not explicitly permitted, the DEA figures, it should be prohibited. The agency apparently was surprised by the backlash against its kratom ban, which included angry phone calls to Capitol Hill, a demonstration near the White House, and letters from members of Congress. The DEA still intends to finalize the ban, although it did not take effect last Friday as expected. Patterson, the DEA spokesman, said the reaction to the ban "was eye-opening for me personally." He added that "I want the kratom community to know that the DEA does hear them." That attitude is quite a contrast to the deaf arrogance the DEA displayed when it announced that it was temporarily placing kratom in Schedule I, a classification that lasts at least two years and could become permanent. Declaring that a ban was necessary "to avoid an imminent hazard to public safety," the DEA summarily dismissed kratom's benefits while exaggerating its dangers. The DEA describes all kratom use as "abuse." It was therefore easy for the agency to conclude that the plant has "a high potential for abuse," one of the criteria for Schedule I. Since the DEA assumed there was no rational, morally acceptable reason to use kratom, it did not need to muster much evidence that the drug is intolerably dangerous. It claimed there have been "numerous deaths associated with kratom," by which it meant 30. In the whole world. Ever. According to the U.S. Centers for Disease Control and Prevention, alcohol causes about 88,000 deaths a year in this country, while 28,000 deaths were attributed to heroin and opioid painkillers in 2014. Kratom looks pretty benign by comparison. Another point to keep in mind: "Deaths associated with kratom" are not necessarily caused by kratom. "Kratom is considered minimally toxic," noted a 2015 literature review in the International Journal of Legal Medicine. "Although death has been attributed to kratom use, there is no solid evidence that kratom was the sole contributor to an individual's death." As further proof of kratom's dangers, the DEA noted that "U.S. poison centers received 660 calls related to kratom exposure" from 2010 through 2015, an average of 110 a year. By comparison, exposures involving analgesics accounted for nearly 300,000 calls in 2014, while antidepressants and antihistamines each accounted for more than 100,000. As the DEA's contrived kratom crisis shows, there is little rhyme or reason to the government's pharmacological taboos, which are driven by unreasoning prejudice rather than science. The one overriding theme is t[...]
Tue, 27 Sep 2016 19:48:00 -0400
Arizona's Goldwater Institute has been the national leader in promoting "right to try" legislation, which allows terminally-ill Americans to legally try medications that have passed just Phase I of the Food and Drug Administration's (FDA) approval process but are not as yet legally available via doctors. Passing Phase I means that the agency is at least satisfied that the medicine can be used safely.
Today the Institute announces that, with a bill signed into law by California Gov. Jerry Brown, that state becomes the 32nd state to pass a version of that law. Brown had vetoed a similar law last year. The Institute's press release notes that "Right To Try is limited to patients with a terminal disease that have exhausted all approved treatment options and cannot enroll in a clinical trial. All medications available under the law must have successfully completed basic safety testing and be part of the FDA's on-going approval process."
KPCC radio's website has more details on the California politics:
Patients must meet a number of requirements to qualify for the program, including that they have only a matter of months to live and that two doctors recommend they try the experimental drug.
The passage of the measure caps a two-year effort by Calderon. Last year, Brown vetoed similar legislation Calderon authored. The governor said he did so because he first wanted to see whether changes in the FDA's Compassionate Use program reduced the minimum 30-day wait for experimental drugs.
And while the feds did streamline some parts of that program, patient wait times remained the same, the bill's supporters say.
Alex Manning's Reason TV video on the right-to-try movement:
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Mon, 26 Sep 2016 06:30:00 -0400Insys Therapeutics, the Arizona-based pharmaceutical company that recently became the biggest financial supporter of the campaign against marijuana legalization in that state, makes an oral spray that delivers the opioid painkiller fentanyl and plans to market another one that contains dronabinol, a synthetic version of THC. Insys says it gave $500,000 to the main group opposing Arizona's legalization initiative because the measure "fails to protect the safety of Arizona's citizens, and particularly its children." But one needn't be terribly cynical to surmise that Insys also worries about the impact that legalization might have on its bottom line, since marijuana could compete with its products. A new study suggests Insys has good reason to worry. In an article published last week by the American Journal of Public Health, Columbia University epidemiologist June Kim and her colleagues report that fatally injured drivers are less likely to test positive for opioids in states that allow medical use of marijuana. That finding, together with the results of earlier studies, indicates that making marijuana legally available to patients saves lives by reducing their consumption of more dangerous medications. Kim et al. collected data from the Fatality Analysis Reporting System (FARS) for 1999 through 2013, focusing on 18 states that drug-tested at least 80% of drivers who died in crashes. They found that drivers between the ages of 21 and 40 were half as likely to test positive for opioids in states that had implemented medical marijuana laws (MMLs) as in states that had not. "Among 21-to-40-year-old deceased drivers, crashing in states with an operational MML was associated with lower odds of testing positive for opioids than crashing in MML states before these laws were operational," the researchers write. "Although we found a significant association only among drivers aged 21 to 40 years, the age specificity of this finding coheres with what we know about MMLs: a minimum age requirement restricts access to medical marijuana for most patients younger than 21 years, and most surveyed medical marijuana patients are younger than 45 years." The fact that a driver tested positive for opioids does not necessarily mean the painkillers he took contributed to the crash, so it is not safe to draw any conclusions about medical marijuana's impact on traffic safety from this study. But the FARS data are an indirect way of measuring the extent of opioid consumption in a given state. Kim et al. note that "severe or chronic pain is among the most common indications cited by medical marijuana patients." It therefore makes sense that opioid use would decline (or rise less) in states that recognize cannabis as a medicine. The FARS numbers reinforce the results of another recent study, published last July in the journal Health Affairs, that looked at prescriptions covered by Medicare from 2010 through 2013. Ashley Bradford, a graduate student in public policy at the University of Georgia, and her father, W. David Bradford, an economist at the same school, found that "the use of prescription drugs for which marijuana could serve as a clinical alternative fell significantly once a medical marijuana law was implemented." The most dramatic decline was in painkiller prescriptions, which fell by 3,645 daily doses per physician after medical marijuana laws were implemented. There were also statistically significant drops in prescriptions for drugs used to treat seizures (down 1,370 daily doses per doctor), depression (1,280), psychosis (1,123), anxiety (1,106), nausea (1,028), and sleep disorders (615). Meanwhile, Bradford and Bradford "found no changes after implementation of a medical marijuana law in the number of daily doses filled in condition categories with no medical marijuana indication," which "provi[...]
Fri, 23 Sep 2016 06:30:00 -0400
(image) While sounding the alarm about an "opioid epidemic" that included a record number of painkiller-related deaths in 2014, the federal government insists marijuana has "no currently accepted medical use." As I explain in my latest Forbes column, that dogmatism may be deadly:
Insys Therapeutics, the Arizona-based pharmaceutical company that recently became the biggest financial supporter of the campaign against marijuana legalization in that state, makes an oral spray that delivers the opioid painkiller fentanyl and plans to market another one that contains dronabinol, a synthetic version of THC. Insys says it gave $500,000 to the main group opposing Arizona's legalization initiative because the measure "fails to protect the safety of Arizona's citizens, and particularly its children." But one needn't be terribly cynical to surmise that Insys also worries about the impact that legalization might have on its bottom line, since marijuana could compete with its products.
A new study suggests Insys has good reason to worry. In an article published last week by the American Journal of Public Health, Columbia University epidemiologist June Kim and her colleagues report that fatally injured drivers are less likely to test positive for opioids in states that allow medical use of marijuana. That finding, together with the results of earlier studies, indicates that making marijuana legally available to patients saves lives by reducing their consumption of more dangerous medications.
Wed, 21 Sep 2016 04:00:00 -0400
(image) Lia Sommer says that as soon as she bit into the sandwich she bought in the cafeteria at John Hersey High School in Illinois she knew she'd been exposed to peanuts. Sommer, who has a potentially deadly peanut allergy, says she was already starting to feel the effects as she rushed to the school nurse. But instead of administering an EpiPen and calling 911 as called for in the medical plan the school had on file for Sommer, the nurse tried to convince her to just take some Benadryl. Sommer had to call her mother and get her to talk to the nurse before the nurse would administer the EpiPen and call for an ambulance.
Fri, 16 Sep 2016 07:30:00 -0400Officials at the Drug Enforcement Administration (DEA) seem to have been surprised by the negative reaction to the agency's "temporary" ban on kratom, which it implausibly claimed was necessary "to avoid an imminent hazard to public safety." That ban, which will last at least two years, can be extended for another year, and during that time the DEA is supposed to go through the motions of justifying the decision it has already made. But according to DEA spokesman Melvin Patterson, the agency may decide not to keep kratom in Schedule I, the most restrictive category under the Controlled Substances Act (CSA). "I don't see it being Schedule II [or higher] because that would be a drug that's highly addictive," Patterson tells Washington Post drug policy blogger Christopher Ingraham. "Kratom's at a point where it needs to be recognized as medicine. I think that we are going to find out that probably it does [qualify as a medicine]." Patterson makes it sound as if the DEA had no idea Americans were using kratom for medical purposes, even though it discusses those uses in its explanation of the ban. The storm of protest from medical users of kratom, which included a demonstration near the White House on Tuesday, "was eye-opening for me personally," Patterson says. "I want the kratom community to know that the DEA does hear them. Our goal is to make sure this is available to all of them." And what better way to do that than banning all kratom products? Patterson's comments are surprising, not least because they contradict conclusions the DEA already has reached about kratom, a pain-relieving leaf from Southeast Asia that recently gained a following in the United States as a home remedy and recreational intoxicant. Explaining why it decided to ban kratom, the DEA says "available information indicates that [mitragynine and 7-hydroxymitragynine, kratom's main active ingredients] have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision." Those are the criteria for Schedule I, which Patterson now says is not appropriate for kratom. Although the DEA does not have to demonstrate that kratom meets the criteria for Schedule I to put it there temporarily, it goes to great lengths to show that kratom has "a high potential for abuse," mainly by classifying everything people do with it as abuse. Under the CSA, drugs in the top two schedules are all supposed to have a "high potential for abuse," while drugs in lower schedules (III through V) are supposed to have progressively less abuse potential. Patterson suggests a drug cannot have a high potential for abuse unless it is "highly addictive," which kratom is not. Yet neither are many other substances in Schedule I, including marijuana, qat, LSD, psilocybin, mescaline, MDMA, and dimethyltryptamine, assuming addictiveness is measured by the percentage of people who become heavy users after trying a drug. Evidently a drug need not be highly addictive to be placed in Schedule I. Nor does the DEA define abuse potential based on the hazards a drug poses. Chuck Rosenberg, the agency's acting administrator, notes that "Schedule I includes some substances that are exceptionally dangerous and some that are less dangerous (including marijuana, which is less dangerous than some substances in other schedules)." Emphasis mine, because people tend to assume that Schedule I is a list of what the DEA considers to be the world's most dangerous drugs. The DEA does not see it that way. "It is best not to think of drug scheduling as an escalating 'danger' scale," Rosenberg says. If "high potential for abuse" does not refer to addictiveness or to danger, what does it signify? Nothing [...]
Sun, 04 Sep 2016 12:24:00 -0400In 2015, about 3.5 million people were prescribed an EpiPen, an injection device with a pre-measured dose of epinephrine used to treat potentially fatal allergic reactions. Controversy over the fast-rising costs of the device has been used to indict the American health-care system as a playground for corporate greed. Over the past five years or so, the list price of a two-pack of EpiPends has increased about 400 percent, to $600. (Of course, what any customer might pay out-of-pocket is dependent on many factors such as insurance company, income level, and more.) Well, there's no question that the maker of the EpiPen, Mylan, is in business to make money. The CEO of the company, which is the largest maker of generic drugs in the country, says, "I am a for-profit business. I am not hiding from that." It's actually kind of great to hear a CEO unapologetically say so. But as Scott Shackford recently noted at Reason.com, the main problem is that Mylan has been granted a de facto monopoly over the market for epinephrine injectors. That isn't because it built a better mousetrap but because the Food & Drug Administration (FDA) has shot down virtually every alternative device for one reason or another. As I write in a new Daily Beast column, Mylan's path to monopoly pricing in EpiPens has everything to do with politics and nothing to with laissez-faire economics. The approval process isn't just long and expensive, it also opens things up to politics. That's one of the reasons why Mylan, which bought the rights to EpiPen in 2007, spent more than $2 million lobbying Washington in 2015. The company's PAC has spent about $80,000 so far in the 2016 election cycle. Maybe it's just coincidence, but Mylan, one of the largest generic drug companies on the planet, faces little competition from other companies that want to make devices similar to the EpiPen. As the pseudonymous doctor Scott Alexander documents at Slate Star Codex, the amount of epinephrine in an EpiPen's pre-measured dose costs about 10 cents a shot. But every time a new company tries to bring a rival product to market, the Food and Drug Administration (FDA) finds a reason to just say no. Sandoz, Teva Pharmaceuticals, Sanofi, and Adamis have all tried and failed. That seems more than a little fishy given the relative simplicity of the basic drug and delivery system involved. We're not talking brain surgery here—we're talking about a pre-loaded, single-use syringe. Let's be clear: The basic protocols that the FDA uses to approve drugs and devices are outdated and make new products far more limited and far more expensive than they need to be. Indeed, as medical researchers push forward into an era of hyper-personalized "molecular medicine" that is based on individual genomic differences among patients, the FDA insists on clinical trials that are based on average experiences. Some drugs work for some patients but not others, notes researcher Peter Huber of the Manhattan Institute. It costs somewhere between $1 billion and $5.8 billion and between 10 years and 15 years to bring new drugs to market (where maybe 20 percent become blockbusters). Yet for politicians on both sides of the aisle, the fix to the EpiPen is to threaten price controls. Here's an excerpt from a letter released by Hillary Clinton, in which she avers that the EpiPen price hike is just the latest troubling example of a company taking advantage of its consumers. I believe that our pharmaceutical and biotech industries can be an incredible source of American innovation, giving us revolutionary treatments for debilitating diseases. But it's wrong when drug companies put profits ahead of patients, raising prices without justifying the value behind them. "That's[...]
Tue, 30 Aug 2016 08:50:00 -0400
The Burning Man festival, that week long experiment in temporary art-centered community in Nevada's difficult Black Rock desert, is in full swing as of yesterday. (And my book about the event's history and culture, in a conveniently updated 10th anniversary e-book edition, is for sale for $4.99 for your Kindle.)
A series of documents made public recently document a grim incident from the event last year that spotlights the crummy things that can happen when medical care is mixed with law enforcement.
In a letter in my possession sent in May by the state's Division of Public and Behavioral Health, a medic who worked the event last year was put on warning for, as the letter stated, administering ketamine (a powerful tranquilizer that is also sometimes used recreationally) unasked for to a Burning Man attendee "as necessary for the overall safety of law enforcement officials who were in contact with the attendee." (The state later rescinded the warning, on the stated grounds that their investigation had happened too late after the actual event being investigated, though the letter rescinding the warning said nothing to suggest the event she was originally warned for had not happened.)
In a letter sent earlier this month from Harley Dubois, a member of Burning Man's board of directors, to Mel Hummel, president of the board of trustees of Humboldt General Hospital who supplied the medic in question, she noted the woman shot with the ketamine was 110 pounds, had been drinking alcohol, and as a result of the ketamine injection the woman "went into respiratory failure—twice—and nearly died."
The Reno Gazette-Journal reported on the incident in the context of wranglings between Burning Man, Humboldt General Hospital, and law enforcement last week over how to set and obey protocols for medical issues at Burning Man moving forward. The medic injected the ketamine "while serving as a special reserve deputy under Pershing County Sheriff's Office, according to contracts with the Pershing County Sheriff's Office," reported the Gazette-Journal.
Like ketamine and alcohol, medical care and police work can be a very dangerous combination. See my previous reporting on hospitals who decide to conduct unasked for anal probes to help cops search for drugs, and then bill the unwilling "patient"/victim.
My 2000 Reason cover story on the event's fractious relationship with government authorities. My reporting from last year on the fruitless and aggravating practice of the Bureau of Land Management law enforcement running mail sent to Burning Man by drug dogs.