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Psilocybin may be useful in treating anxiety, addiction, and depression, and in studying the neurobiology of mystical experience.
On an April Monday in 2010, Patrick Mettes, a fifty-four-year-old television news director being treated for a cancer of the bile ducts, read an article on the front page of the Times that would change his death.
About type 1 diabetes Around 2.6 million people in the UK have been diagnosed with diabetes. Hepatitis C is an infectious disease caused by a virus of the flavoviridae family that can infect and damage the liver.
People become infected with hepatitis because of blood-to-blood contact associated with intravenous drug use, poorly sterilized medical equipment and transfusions.
In an estimated one in five cases of hepatitis C, the immune system will successfully eliminate the virus and the person will have no further symptoms (unless they become infected again).
Depending on other risk factors, such as alcohol use, between 10% and 40% of people with untreated chronic hepatitis C will go on to develop scarring of the liver ( cirrhosis ), often more than twenty years after first catching the virus. In general, treatment is recommended for those with proven HCV infection liver abnormalities; treatments consisted of a combination of pegylated interferon alpha (polyethylene glycol is added to make the interferon last longer in the body) and the antiviral drug ribavirin for a period of 24 or 48 weeks, depending on HCV genotype.
Although the results has been encouraging, this treatment can cause cause severe nausea and depression, and other debilitating symptoms such as itchy skin, rash, tiredness, nausea, anemia, neutropenia. Emergence of new drug-resistant virus strains are rare also because the virus does not have an animal reservoir, meaning that it is not harboured by other animals, and it is not easily spread between people, except through blood. In December 2013, US Food and Drug Administration (FDA) approved a new drug , Sofosbuvir (brand name, SOVALDI™) from Gilead Sciences in Foster City, California for Hepatitis C treatment. Sofosbuvir and other nucleotide inhibitors of the HCV RNA polymerase exhibit a very high barrier to resistance development.
From December 2013, Sofosbuvir is a component of the first all-oral, interferon-free regimen approved for treating chronic hepatitis; interferon-free therapy for treatment of hepatitis C reduces the side effects associated with use of interferon.
The FDA approved Sofosbuvir in combination with ribavirin (RBV) for oral dual therapy of HCV genotypes 2 and 3, and for triple therapy with injected pegylated interferon (pegIFN) and RBV for treatment-naive patients with HCV genotypes 1 and 4. As Sofosbuvir is always combined with other drugs such as ribavirin and interferon, only the adverse effects of these combinations have been evaluated.
Sofosbuvir is a substrate of drug transporter P-gp and breast cancer resistance protein (BCRP). The intracellular metabolic activation pathway of Sofosbuvir is mediated by generally low affinity and high capacity hydrolase and nucleotide phosphorylation pathways that are unlikely to be affected by concomitant drugs. Sofosbuvir will cost $84,000 for 12 weeks of treatment used for genotype 1 and 2, and $168,000 for the 24 weeks used for genotype 3. Sofosbuvir was approved by the European Medicines Agency (EMA) in January 2014; marketing of Sofosbuvir, authorized in all the 28 country of European Union, will be in 400 mg tablets for once-a-day oral administration, in association with other antiviral agents, while mono therapy is not recommended. The authorization was supported by five “Phase 3” studies data, NEUTRINO , FISSION , POSITRON , FUSION and VALENCE . Nowadays, Sofosbuvir has been approved in USA, Canada, Europe; authorization is on examination in Australia, New Zealand, Switzerland and Turkey. Hepatitis C virus is a single-stranded RNA virus, and its open-reading frame encodes ten structural proteins (viral capsid and envelope) and non-structural proteins (required for viral replication).
The effect of sofosbuvir 400 and 1200 mg on QTc interval was evaluated in a randomized, single-dose, placebo-, and active-controlled (moxifloxacin 400 mg) four period crossover thorough QT trial in 59 healthy subjects. The pharmacokinetic properties of sofosbuvir and the predominant circulating metabolite GS-331007 have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Relative to fasting conditions, the administration of a single dose of SOVALDI with a standardized high fat meal did not substantially affect the sofosbuvir Cmax or AUC0-inf.
Sofosbuvir is extensively metabolized in the liver to form the pharmacologically active nucleoside analog triphosphate GS-461203. Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the dose was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, feces, and expired air, respectively. Sofosbuvir is an inhibitor of the HCV NS5B RNA-dependent RNA polyme-rase, which is essential for viral replication. HCV replicons with reduced susceptibility to sofosbuvir have been selected in cell culture for multiple genotypes including 1b, 2a, 2b, 3a, 4a, 5a and 6a. In a pooled analysis of 982 subjects who received SOVALDI in Phase 3 trials, 224 subjects had post-baseline NS5B genotypic data from next generation nucleotide sequencing (assay cutoff of 1%).
Treatment-emergent substitutions L159F (n= 6) and V321A (n= 5) were de-tected in post-baseline samples from GT3a-infected subjects across the Phase 3 trials.
In the trial done in subjects with hepatocellular carcinoma awaiting liver transplantation where subjects received up to 48 weeks of sofosbuvir and ribavirin, the L159F substitution emerged in multiple subjects with GT1a or GT2b HCV who experienced virologic failure (breakthrough and relapse).
HCV replicons expressing the sofosbuvir-associated resistance substitution S282T were susceptible to NS5A inhibitors and ribavirin. In the FISSION study, 499 treatment-naive patients with genotype 2 or 3 HCV were randomized to sofosbuvir 400 mg plus ribavirin for 12 weeks or peginterferon plus ribavirin for 24 weeks in a noninferiority trial.
The NEUTRINO study was a 12-week open label study of sofosbuvir plus ribavirin in treatment naive patients with HCV genotype 1, 4, 5 or 6 (of whom 98% had genotype 1 or 4). POSITRON evaluated sofosbuvir plus ribavirin compared with placebo in patients with genotype 2 and 3 HCV in whom interferon was not an option (previously intolerant of interferon, unwilling or unable to take interferon). The FUSION study was a blinded, active-control study involving patients with genotype 2 or 3 HCV who had not had a response to prior treatment with an interferon-containing regimen. One obvious clinical need is for data regarding safety and efficacy of sofos-buvir in patients who have decompensated chronic liver disease, are peri-transplant or post-liver-transplant. The US FDA has recently (6 December, 2013) approved sofosbuvir under the brand name Sovaldi for the treatment chronic HCV infection under a breakthrough therapy designation, because it has shown a substantial improvement over the other available therapies.
Although sofosbuvir is by no means one of the first DAA drugs to reach phase III clinical trials, the collective trial data for sofosbuvir do represent a significant paradigm shift in the management of HCV infection. During its October 2013 meeting, the CHMP gave an opinion on the conditions under which early access to sofosbuvir, in combination with other medicines, could be given in compassionate-use programmes, for patients with chronic hepatitis C infection before or after liver transplantation. Such programmes, set up at the national level (in italy as well), are intended to give patients with a life-threatening, long-lasting or seriously disabling disease who have no available treatment options access to treatments that are still under development and that have not yet been authorised.
During its November meeting, the CHMP also provided an opinion on the use of a combination of sofosbuvir with the antiviral daclatasvir in certain patients with chronic hepatitis C virus (HCV) infection, in a compassionate-use programme.
From the above discussion, it seems that sofosbuvir is a promising therapy for chronic HCV infection, as it offers several advantages over the existing therapies, particularly in dealing with patients with decompensated liver disease and patients who cannot tolerate interferon-containing therapies.
When the umbilical cord is cut, it leaves a stump, which then dries, heals, and usually falls off within 1 - 3 weeks.
New Jersey has seen one of the biggest jumps in bed bug infestations in America in recent years; and lawmakers aren’t taking it lying down. Hotels, hospitals, homeless shelters and nursing homes will all be affected; and it’s hoped this measure will help stop the spread of what’s becoming an increasingly difficult-to-manage problem.
If you want an example of bed bug control mismanagement, you have no further to look than the self-same New Jersey; where this new legislation is being introduced.
In January of this year, a bed bug pest control company in New Jersey lost its license and was fined almost a million dollars by the New Jersey state government after it was discovered they were using bed bug control chemicals that had been banned in the United States because they posed serious health risks. Taking bed bug management into your own hands is a bold step; but offers complete control over how you tackle a bed bug infestation and the chemicals and materials you expose yourself and your family to.
While most exterminators and pest control companies use hazardous synthetic chemicals to treat bed bugs, there remain 100% natural alternatives that use natural ingredients to force biological reactions in bed bugs that can immobilize and kill them in seconds. And, unlike the treatments traditionally used by exterminators, bed bugs can’t develop a resistance to these natural bed bug treatments; as they use the same reactions to eliminate bed bugs as those found in nature. The best advice for dealing with a bed bug infestation is to pause before you pick up the phone to your local exterminator. Residents of Bergen County New Jersey NJ can call 954-931-2500 for help finding Heroin and Opiate Drug Addiction Treatment centers.
After over 18 months in development, the FibroTrack online fibromyalgia management system will launch in early December 2012. FibroTrack, a new leader in fibromyalgia management, announces that the innovative online management system will launch in December 2012. The FibroTrack system empowers fibromyalgia treatment efforts with a technology enhanced scientific process aimed at developing a proven effective, individually tailored, multi-dimensional treatment approach. As an interactive web application, the platform features intuitive point and click interfaces which make the fibromyalgia management process both simple and fun. Fibromyalgia is a confusing and often controversial chronic pain condition that affects millions of people worldwide. After over 18 months in planning and development, the FibroTrack system is set to launch in the first week of December 2012. Reach out to the author: contact and available social following information is listed in the top-right of all news releases. His diagnosis had come three years earlier, shortly after his wife, Lisa, noticed that the whites of his eyes had turned yellow. In most cases, hepatitis C causes no noticeable symptoms until the liver has been significantly damaged. Around one in five people with cirrhosis will then develop liver failure, and one in 20 will develop liver cancer, both of which can be fatal.
This treatment was shown to cure rates of between 70 and 80% for genotype 2 and 3, and 45 to 70% for other genotypes.
Improved screening of blood supplies used for transfusions and better patient-screening techniques have already greatly cut transmission rates over the last 15 years.
The major point of this decision was a study in which it was shown that if taken in combination with ribavirin, the treatment eliminates hepatitis C in around 80% of people. The triphosphate acts like a substrate for the viral RNA polymerase, and inhibites of viral RNA synthesis. This is an important advantage relative to HCV drugs that target other viral enzymes such as the protease, for which rapid resistance development has proved to be an important cause of therapeutic failure. Sofosbuvir treatment regimens last 12 weeks for genotypes 1, 2 and 4, and 24 weeks for treatment of genotype 3.
The price has moved controversy, with critics contending the drug is unaffordable and supporters suggesting that the drug brings price savings relative to older treatments associated with severe side effects, lengthy treatment, and low cure rates. The uridine nucleotide analog sofosbuvir is a phosphoramidate prodrug that has to be triphosphorylated within the cells to produce its action. At a dose three times the maximum recommended dose, SOVALDI does not prolong QTc to any clinically relevant extent. Following oral administration of SOVALDI, sofosbuvir was absorbed with a peak plasma concentration observed at ~0.5-2 hour post-dose, regardless of dose level. The metabolic activation pathway involves sequential hydrolysis of the carboxyl ester moiety catalyzed by human cathepsin A (CatA) or carboxylesterase 1 (CES1) and phosphoramidate cleavage by histidine triad nucleotide-binding protein 1 (HINT1) followed by phosphorylation by the pyrimidine nucleotide biosynthesis pathway. The majority of the sofosbuvir dose recovered in urine was GS-331007 (78%) while 3.5% was recovered as sofosbuvir. Sofosbuvir is a nucleotide pro-drug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. Reduced susceptibility to sofosbuvir was associated with the primary NS5B substitution S282T in all replicon genotypes examined. No detectable shift in the phenotypic susceptibility to sofosbuvir of subject isolates with L159F or V321A substitutions was seen. HCV replicons expressing the ribavirin-associated substitutions T390I and F415Y were susceptible to sofosbuvir. It has the key function of replicating the HCV's viral RNA by using the viral positive RNA strand as its template and catalyzes the polymerization of ribonucleoside triphosphates (rNTP) during RNA replication.
In this trial, despite a marked difference in the RVR rates (99% versus 67%, respectively), the SVR12 rates were identical at 67% [Lawitz et al.
SVR12 rates of 90% were observed overall, with 81% response rates in genotype 1 with cirrhosis. Patients were randomly assigned to either 12 weeks of sofosbuvir and ribavirin followed by 4 weeks of matching placebo, or 16 weeksof sofosbuvir and ribavirin. The excellent safety data to date and the lack of significant drug interactions makes sofosbuvir an appealing choice to be studied in these groups. The most interesting feature of this approval lies in the fact that this drug can be administered without the need of interferon therapy.
With sofosbuvir-based regimens, successful interferon-free treatment of HCV is now achievable across multiple genotypes, but different patterns of genotypic response to treatment have emerged compared with those seen in traditional interferon-based therapy.
On account of its excellent performance in clinical trials, this drug has got FDA approval on 6 December, 2013, under the breakthrough therapy designation.
Recent state legislation is forcing all businesses with beds to pre-sign anti-bed bug treatment with bed bug professionals.
Already pest control professionals report bed bugs jumping from just 15% of their pest management work to over 80% in less than five years; illustrating how severe the problem has become.
In fact, many people are getting fed up with traditional exterminators entirely; preferring instead to tackle bed bug problems themselves – rather than pay for costly services that don’t always deliver results. Designed with a basis in multiple research studies, FibroTrack empowers fibromyalgia treatment efforts with a scientific process aimed at developing a proven effective, individually tailored, multi-dimensional treatment approach. It is a tool to help you build your best combination of treatments and to help you better manage your fibromyalgia! FibroTrack is an online fibromyalgia management system built to aid patients in researching, defining, testing and validating an individually tailored treatment program. The system includes tremendous resources for treatment research, symptoms tracking, treatment tracking, comprehensive reporting functions, social networking, online support groups, care team coordination and management plus much more. FibroTrack also includes mobile companion applications for the iPhone and Android devices that enable the easy tracking of symptoms and treatment actions - anywhere – anytime. It is a tool to help you build your best combination of treatments and to help you better manage your fibromyalgia!" says Terry Springer, the founder of Online Awesome LLC and designer of the FibroTrack system. Jan Chambers, President of the NFMCPA, says "Finding the lifestyle, medication, or combination of treatment changes to reduce fibromyalgia symptoms is at the heart of self management.
Symptoms are primarily defined by persistent, pervasive and often severe pain that frequently takes on different characteristics from patient to patient.
By 2010, the cancer had spread to Patrick’s lungs and he was buckling under the weight of a debilitating chemotherapy regimen and the growing fear that he might not survive. It can develop at any age, but usually affects people before the age of 40, and most commonly during childhood.
When symptoms do occur, they are often vague and can be easily mistaken for another condition. But researchers has been studying new treatments to increase cure rates, to avoid collateral effects and to eliminate latent form of the virus.
Also in another study, a combination of Sofosbuvir and Simeprevir in 197 people with HCV who had either not responded to interferon or who had advanced liver fibrosis caused by the virus cleared the virus in more than 90% of participants. Prior to the discovery of Sofosbuvir, a variety of nucleoside analogs had been examined as anti-hepatitis C treatments, but these exhibited relatively low potency. Most side effects are significantly more common in interferon containing regimens as compared to interferon-free ones.
John's wort) may decrease Sofosbuvir plasma concentration leading to reduced therapeutic effect of it and thus should not be used with.
There is also concern that patients in developing countries may not have sufficient access due to high prices; a key issue is that there are no international agencies or groups that purchase hepatitis C drugs for distribution to poor countries.
The required enzymes for its activation are present in the human hepatic cells, therefore, it is converted to its active metabolite during the first-pass metabolism, directly at the desired site of action: The liver.


After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of 14C-radioactivity was approximately 0.7. Dephosphorylation results in the formation of nucleoside metabolite GS-331007 that cannot be efficiently rephosphorylated and lacks anti-HCV activity in vitro.
An M289L substitution developed along with the S282T substitution in genotype 2a, 5 and 6 replicons.
The sofosbuvir-associated resistance substitution S282T was not detected at baseline or in the failure isolates from Phase 3 trials. In addition, S282R and L320F substitutions were detected on-treatment by next generation sequencing in a subject infected with GT1a HCV with a partial treatment response.
Several crystal structures of NS5B polymerase in several crystalline forms have been determined based on the same consensus sequence BK (HCV-BK, genotype 1).
These cirrhotic patients also had extremely low rates of treatment discontinuation of only 2%, suggesting that this combination is safe and extremely well tolerated even in cirrhotic patients [Lawitz et al. Degree of liver fibrosis did not appear to significantly influence outcomes in genotype 2 patients (94% SVR12 even in those with cirrhosis), but in genotype 3 patients, SVR12 rates were low at 21% in patients with cirrhosis [Jacobson et al. To date there is one case report published of a patient with severe recurrent cholestatic hepatitis C, 6 months post-transplant, who was effectively rescued and achieved SVR with treatment with sofosbuvir and daclatasvir in combination [Fontana et al.
It is now clear that in the current DAA era, genotypes 2 and 3 should be evaluated quite separately, as SVR rates in genotype 3 patients are significantly lower than those seen in genotype 2 [Jacobson et al.
This drug is effective against all HCV genotypes, has a better safety profile, and low risk of development of resistance; however, careful clinical use and monitoring is still essential, to gather more data on this drug.
In order to keep the cord dry, sponge bathe your baby rather than submersing him in a tub of water. Watch the umbilical cord for infection. The NFMCPA recognizes that living better with fibromyalgia is based on practicing self management.
Only around 15% of cases shows symptoms during the first six months of a hepatitis C infection: this stage is known as acute hepatitis C.
This low potency originates in part because the enzymatic addition of the first of the three phosphate groups of the triphosphate is slow. For example, fatigue and headache are nearly cut in half, influenza-like symptoms are reduced to 3–6% as compared to 16–18%, and neutropenia is almost absent in interferon-free treatment.
Sofosbuvir should not be taken in association with anticonvulsants, antimycobacterials, HIV protease inhibitors. Doctors of the world and other association wrote an essay to stress the inability of most of common people and country to cope with such high prices.
The median terminal half-lives of sofosbuvir and GS-331007 were 0.4 and 27 hours, respectively. Site-directed mutagenesis of the S282T substitution in replicons of 8 genotypes conferred 2- to 18-fold reduced susceptibility to sofosbuvir and reduced the replication viral capacity by 89% to 99% compared to the corresponding wild-type. However, an S282T substitution was detected in one genotype 2b subject who relapsed at Week 4 post-treatment after 12 weeks of sofosbuvir monotherapy in the Phase 2 trial P7977-0523 [ELECTRON]. Notably, in this study there was a marked difference in response rates between patients with genotype 2 (97% SVR 12) and genotype 3 (56% SVR12) HCV, and between cirrhotic (47% SVR12) and noncirrhotic (72% SVR12) patients. Overall rates of SVR were significantly higher in the 16-week arm (73%) than in the 12-week arm (50%), and again the genotype 2 patients had higher SVR rates (86% and 94% for 12 and 16 weeks, respectively) than genotype 3 patients (30% and 62% respectively for 12 and 16 weeks) [Jacobson et al.
Earlier it was under the FDA's priority review program (an expedited review of drugs useful for serious conditions, which, after their approval, would provide significant improvement in safety or effectiveness).
Data on the effectiveness of this combination in cirrhotic genotype 1 null responders is awaited. Large post-marketing studies, including pharmacoepidemiological and pharmacovigilance studies, can solve many unanswered questions for the future of this novel drug. A wide range of commonly linked conditions include Chronic Fatigue Syndrome, Irritable Bowel Syndrome and many others. The symptoms may include high temperature, tiredness, loss of appetite and they occur a few weeks after infection. Some of the most commonly reported symptoms of hepatitis C include: tiredness, headaches, depression, problems with short-term memory, concentration and completing relatively complex mental tasks, joint and muscle aches and pain, itchy skin, flu-like symptoms, like those that occur in the acute phase of the infection, abdominal pain, pain in the liver area (which is located in the right upper side of abdomen).
The design of Sofosbuvir avoids this slow step by building the first phosphate group into the structure of the drug during synthesis. This analog then mimics the physiological nucleotide and competitively blocks the NS5B polymerase, thus inhibiting the HCV-RNA synthesis by RNA chain termination.
Relative to healthy subjects administered sofosbuvir alone (N = 272), the sofosbuvir AUC0-24 was 39% higher and GS-331007 AUC0-24 was 39% lower, respectively, in HCV-infected subjects. Evaluation of sofosbuvir in combination with interferon alpha or ribavirin showed no antagonistic effect in reducing HCV RNA levels in replicon cells. The isolate from this subject displayed a mean 13.5-fold reduced susceptibility to sofosbuvir. The encircled active site, unique to NS5B, is contained within the palm structure of the protein. This is promising, and results of future trials of sofosbuvir in these types of patient groups are awaited with interest.
Positive results from major clinical trials, plus a demonstration of efficacy in patients who cannot tolerate interferon-based regimens and in patients with liver cancer undergoing liver transplantation, make this drug a valuable and very useful therapy for these patient populations. A new era of successful interferon-free DAA therapy for HCV is emerging, with potential to broaden treatment of HCV to include patient groups who have either avoided or not been suitable for previous interferon- based therapy, and it is likely that sofosbuvir will form the backbone of this treatment approach. As of now, sofosbuvir is among the most promising agents available for the treatment of chronic HCV infection. Additional groups are attached to the phosphorus to temporarily mask the two negative charges of the phosphate group, thereby facilitating entry of the drug into the infected cell.
The catalytic site of the enzyme is also highly conserved across all the HCV genotypes, accounting for pan-genotypic efficacy of sofosbuvir.
Sofosbuvir and GS-331007 AUCs are near dose proportional over the dose range of 200 mg to 1200 mg. For this subject,the S282T substitution was no longer detectable at Week 12 post-treatment by next generation sequencing with an assay cut off of 1%.
Recent studies on NS5B protein genotype 1b strain J4’s (HC-J4) structure indicate a presence of an active site where possible control of nucleotide binding occurs and initiation of de-novo RNA synthesis. Cirrhosis was associated with a decreased rate of SVR, particularly in genotype 3 receiving 12 weeks of therapy rather than 16 weeks (SVR 19% versus 61%).
Effective fibromyalgia treatment is notoriously difficult as patients tend to respond to different treatment options individually. In genotype 2 patients SVR rates ranged from 60% to 78% in cirrhotic patients, and up to 100% in noncirrhotic patients without cirrhosis who were treated for 16 weeks. In contrast, the presence of advanced liver fibrosis has a significant detrimental effect on SVR rates in genotype 3 patients when a 12-week regimen is used. Current research attempts to bind structures to this active site to alter its functionality in order to prevent further viral RNA replication. Treatment is further complicated by the reality of hundreds of potentially effective treatment options and combinations of options. Since hallucinogens can sometimes bring to the surface latent psychological problems, researchers try to weed out volunteers at high risk by asking questions about drug use and whether there is a family history of schizophrenia or bipolar disorder. The other strategy that could be considered is addition of another DAA to the regimen, but until these data are available to clarify the optimal interferon-free treatment of genotype 3 HCV patients with advanced fibrosis or previous treatment failure, there may be an initial role for continuing to use peginterferon together with sofosbuvir in this group of patients. If the cord does actively bleed, call your babyA?a‚¬a„?s doctor immediately. Sometimes instead of completely drying, the cord will form a granuloma, which is pink scar tissue. After the screening, Mettes was assigned to a therapist named Anthony Bossis, a bearded, bearish psychologist in his mid-fifties, with a specialty in palliative care.
This condition will usually go away in about a week, but if not, your pediatrician may need to burn off (cauterize) the granulation tissue. The umbilical cord stump should dry up and fall off by the time your baby is 8 weeks old.
If your baby's stump remains beyond that time, there may be a problem with the baby's anatomy or immune system. After four meetings with Bossis, Mettes was scheduled for two dosings—one of them an “active” placebo (in this case, a high dose of niacin, which can produce a tingling sensation), and the other a pill containing the psilocybin. Both sessions, Mettes was told, would take place in a room decorated to look more like a living room than like a medical office, with a comfortable couch, landscape paintings on the wall, and, on the shelves, books of art and mythology, along with various aboriginal and spiritual tchotchkes, including a Buddha and a glazed ceramic mushroom.
During each session, which would last the better part of a day, Mettes would lie on the couch wearing an eye mask and listening through headphones to a carefully curated playlist—Brian Eno, Philip Glass, Pat Metheny, Ravi Shankar.
Bossis and a second therapist would be there throughout, saying little but being available to help should he run into any trouble. He is also the director of the substance-abuse division at Bellevue, and he told me that he had known little about psychedelics—drugs that produce radical changes in consciousness, including hallucinations—until a colleague happened to mention that, in the nineteen-sixties, LSD had been used successfully to treat alcoholics. Beginning in the nineteen-fifties, psychedelics had been used to treat a wide variety of conditions, including alcoholism and end-of-life anxiety.
Between 1953 and 1973, the federal government spent four million dollars to fund a hundred and sixteen studies of LSD, involving more than seventeen hundred subjects.
Sandoz, the Swiss chemical company where, in 1938, Albert Hofmann first synthesized LSD, gave away large quantities of Delysid—LSD—to any researcher who requested it, in the hope that someone would discover a marketable application.
Psychedelics were tested on alcoholics, people struggling with obsessive-compulsive disorder, depressives, autistic children, schizophrenics, terminal cancer patients, and convicts, as well as on perfectly healthy artists and scientists (to study creativity) and divinity students (to study spirituality). But many of the studies were, by modern standards, poorly designed and seldom well controlled, if at all.
It can cause you to vomit, breathe faster than usual and have breath that smells of ketones (like pear drops or nail varnish). When there were controls, it was difficult to blind the researchers—that is, hide from them which volunteers had taken the actual drug. Diabetic ketoacidosis is a medical emergency and can be fatal if you aren’t treated in hospital immediately.
In 1970, Richard Nixon signed the Controlled Substances Act and put most psychedelics on Schedule 1, prohibiting their use for any purpose. Research soon came to a halt, and what had been learned was all but erased from the field of psychiatry. Medical Center, and the University of New Mexico, as well as at Imperial College, in London, and the University of Zurich. As the drug war subsides, scientists are eager to reconsider the therapeutic potential of these drugs, beginning with psilocybin. Researchers are using or planning to use psilocybin not only to treat anxiety, addiction (to smoking and alcohol), and depression but also to study the neurobiology of mystical experience, which the drug, at high doses, can reliably occasion. Forty years after the Nixon Administration effectively shut down most psychedelic research, the government is gingerly allowing a small number of scientists to resume working with these powerful and still somewhat mysterious molecules. However, the way in which type 1 diabetes first starts isn’t fully understood at present, but it's possible it may be caused by a virus or run in families.
According to Ross, cancer patients receiving just a single dose of psilocybin experienced immediate and dramatic reductions in anxiety and depression, improvements that were sustained for at least six months.
The data are still being analyzed and have not yet been submitted to a journal for peer review, but the researchers expect to publish later this year. The fact that a drug given once can have such an effect for so long is an unprecedented finding.
We have never had anything like it in the psychiatric field.” Share Tweet Buy a cartoon I was surprised to hear such unguarded enthusiasm from a scientist, and a substance-abuse specialist, about a street drug that, since 1970, has been classified by the government as having no accepted medical use and a high potential for abuse.
Your GP will arrange for you to have a sample of blood taken from your arm to test for glucose.
Kleber, a psychiatrist and the director of the substance-abuse division at the Columbia University–N.Y.
State Psychiatric Institute, who is one of the nation’s leading experts on drug abuse, struck a cautionary note.
The question is, is it ready for prime time?” The idea of giving a psychedelic drug to the dying was conceived by a novelist: Aldous Huxley. In 1953, Humphry Osmond, an English psychiatrist, introduced Huxley to mescaline, an experience he chronicled in “The Doors of Perception,” in 1954.
Psilocybin mushrooms first came to the attention of Western medicine (and popular culture) in a fifteen-page 1957 Life article by an amateur mycologist—and a vice-president of J. In 1955, after years spent chasing down reports of the clandestine use of magic mushrooms among indigenous Mexicans, Wasson was introduced to them by Maria Sabina, a curandera—a healer, or shaman—in southern Mexico. Wasson’s awed first-person account of his psychedelic journey during a nocturnal mushroom ceremony inspired several scientists, including Timothy Leary, a well-regarded psychologist doing personality research at Harvard, to take up the study of psilocybin. After trying magic mushrooms in Cuernavaca, in 1960, Leary conceived the Harvard Psilocybin Project, to study the therapeutic potential of hallucinogens.
You will usually inject yourself before meals, using either a small needle or a pen-type syringe with replaceable cartridges. In the wake of Wasson’s research, Albert Hofmann experimented with magic mushrooms in 1957. These may be appropriate if you find it difficult to control your blood glucose with regular injections, despite careful monitoring. Perhaps the most influential and rigorous of these early studies was the Good Friday experiment, conducted in 1962 by Walter Pahnke, a psychiatrist and minister working on a Ph.D. In a double-blind experiment, twenty divinity students received a capsule of white powder right before a Good Friday service at Marsh Chapel, on the Boston University campus; ten contained psilocybin, ten an active placebo (nicotinic acid).
Ask your doctor or diabetes specialist nurse for advice on which type and method is best for you.
In 1991, Rick Doblin, the director of the Multidisciplinary Association for Psychedelic Studies (MAPS), published a follow-up study, in which he tracked down all but one of the divinity students who received psilocybin at Marsh Chapel and interviewed seven of them. They all reported that the experience had shaped their lives and work in profound and enduring ways. But Doblin found flaws in Pahnke’s published account: he had failed to mention that several subjects struggled with acute anxiety during their experience. One had to be restrained and given Thorazine, a powerful antipsychotic, after he ran from the chapel and headed down Commonwealth Avenue, convinced that he had been chosen to announce that the Messiah had arrived. The first wave of research into psychedelics was doomed by an excessive exuberance about their potential. For people working with these remarkable molecules, it was difficult not to conclude that they were suddenly in possession of news with the power to change the world—a psychedelic gospel. They found it hard to justify confining these drugs to the laboratory or using them only for the benefit of the sick.
It didn’t take long for once respectable scientists such as Leary to grow impatient with the rigmarole of objective science. He came to see science as just another societal “game,” a conventional box it was time to blow up—along with all the others. Stanislav Grof, a Czech-born psychiatrist who used LSD extensively in his practice in the nineteen-sixties, believes that psychedelics “loosed the Dionysian element” on America, posing a threat to the country’s Puritan values that was bound to be repulsed. Smoking is unhealthy for everyone, but it's especially important to stop if you have diabetes because you already have an increased risk of developing circulatory problems and cardiovascular disease. Can you think of another area of science regarded as so dangerous and taboo that all research gets shut down for decades? These are four to five day intensive courses that help you learn how to adjust your insulin dose.
This involves regularly taking a pinprick of blood from the side of your fingertip and putting a drop on a testing strip.


HbA1C is a protein that is produced when you have high blood glucose levels over a long period of time.
The HbA1C test is done by taking blood from a vein in your arm or sometimes a drop of blood from a fingerprick.
And it opened up the field.” (Even so, psychedelic research remains tightly regulated and closely scrutinized.
Thirty-six volunteers, none of whom had ever taken a hallucinogen, received a pill containing either psilocybin or an active placebo (methylphenidate, or Ritalin); in a subsequent session the pills were reversed. Two-thirds of the participants rated the psilocybin session among the top five most spiritually significant experiences of their lives; a third ranked it at the top.
Furthermore, the “completeness” of the mystical experience closely tracked the improvements reported in personal well-being, life satisfaction, and “positive behavior change” measured two months and then fourteen months after the session.
Griffiths believes that the long-term effectiveness of the drug is due to its ability to occasion such a transformative experience, but not by changing the brain’s long-term chemistry, as a conventional psychiatric drug like Prozac does. A follow-up study by Katherine MacLean, a psychologist in Griffiths’s lab, found that the psilocybin experience also had a positive and lasting effect on the personality of most participants.
This is a striking result, since the conventional wisdom in psychology holds that personality is usually fixed by age thirty and thereafter is unlikely to substantially change. But more than a year after their psilocybin sessions volunteers who had had the most complete mystical experiences showed significant increases in their “openness,” one of the five domains that psychologists look at in assessing personality traits. To a scientist, that’s just incredible.” The revival of psychedelic research today owes much to the respectability of its new advocates. If you don’t monitor your condition regularly and your blood glucose levels get low, you may become very unwell. At sixty-eight, Roland Griffiths, who was trained as a behaviorist and holds senior appointments in psychiatry and neuroscience at Hopkins, is one of the nation’s leading drug-addiction researchers. More than six feet tall, he is rail-thin and stands bolt upright; the only undisciplined thing about him is a thatch of white hair so dense that it appears to have held his comb to a draw. So it’s fascinating that he’s now involved in an area that other people might view as pushing the edge.” Griffiths’s career took an unexpected turn in the nineteen-nineties after two serendipitous introductions.
He told me that meditation acquainted him with “something way, way beyond a material world view that I can’t really talk to my colleagues about, because it involves metaphors or assumptions that I’m really uncomfortable with as a scientist.” He began entertaining “fanciful thoughts” of quitting science and going to India. It can also be caused if you miss a meal, don’t eat enough foods containing carbohydrate or if you take part in physical activity without eating enough to compensate for it. Another cause can be drinking too much alcohol or drinking alcohol without eating beforehand. Jesse was neither a medical professional nor a scientist; he was a computer guy, a vice-president at Oracle, who had made it his mission to revive the science of psychedelics, as a tool not so much of medicine as of spirituality.
He had organized a gathering of researchers and religious figures to discuss the spiritual and therapeutic potential of psychedelic drugs and how they might be rehabilitated.
When the history of second-wave psychedelic research is written, Bob Jesse will be remembered as one of two scientific outsiders who worked for years, mostly behind the scenes, to get it off the ground. Many of the fifteen in attendance were “psychedelic elders,” researchers such as James Fadiman and Willis Harman, both of whom had done early psychedelic research while at Stanford, and religious figures like Huston Smith, the scholar of comparative religion.
But Jesse wisely decided to invite an outsider as well: Bob Schuster, a drug-abuse expert who had served in two Republican Administrations. Jesse flew to Baltimore to meet Griffiths, inaugurating a series of conversations and meetings about meditation and spirituality that eventually drew Griffiths into psychedelic research and would culminate, a few years later, in the 2006 paper in Psychopharmacology.
The journal invited several prominent drug researchers and neuroscientists to comment on the study, and all of them treated it as a convincing case for further research. Maybe we just got off to a bad start.” Share Tweet Buy a cartoon Roland Griffiths and Bob Jesse had opened a door that had been tightly shut for more than three decades. Since 2006, Griffiths’s lab has conducted a pilot study on the potential of psilocybin to treat smoking addiction, the results of which were published last November in the Journal of Psychopharmacology.
Twelve subjects, all of whom had tried to quit multiple times, using various methods, were verified as abstinent six months after treatment, a success rate of eighty per cent. The psychedelic experience seems to allow many subjects to reframe, and then break, a lifelong habit. The volunteers who reported a more complete mystical experience had greater success in breaking the habit.
A larger, Phase II trial comparing psilocybin to nicotine replacement (both in conjunction with cognitive behavioral therapy) is getting under way at Hopkins. Last summer, Florian Holsboer, the director of the Max Planck Institute of Psychiatry, in Munich, told Science, “You can’t give patients some substance just because it has an antidepressant effect on top of many other effects.
That’s too dangerous.” Nora Volkow, of NIDA, wrote me in an e-mail that “the main concern we have at NIDA in relation to this work is that the public will walk away with the message that psilocybin is a safe drug to use.
In fact, its adverse effects are well known, although not completely predictable.” She added, “Progress has been made in decreasing use of hallucinogens, particularly in young people. We would not want to see that trend altered.” The recreational use of psychedelics is famously associated with instances of psychosis, flashback, and suicide. You may need to make changes to your meals if you work shifts, or if food isn't readily available.
After nearly five hundred administrations of psilocybin, the researchers have reported no serious negative effects.
This is perhaps less surprising than it sounds, since volunteers are self-selected, carefully screened and prepared for the experience, and are then guided through it by therapists well trained to manage the episodes of fear and anxiety that many volunteers do report.
Apart from the molecules involved, a psychedelic therapy session and a recreational psychedelic experience have very little in common.
The lab at Hopkins is currently conducting a study of particular interest to Griffiths: examining the effect of psilocybin on long-term meditators. Also, you won’t be allowed to hold a heavy goods vehicle (HGV) licence or be a pilot. It’s a Rip Van Winkle effect—after three decades of no research, we’re rubbing the sleep from our eyes.” “Ineffability” is a hallmark of the mystical experience. Many struggle to describe the bizarre events going on in their minds during a guided psychedelic journey without sounding like either a New Age guru or a lunatic. The available vocabulary isn’t always up to the task of recounting an experience that seemingly can take someone out of body, across vast stretches of time and space, and include face-to-face encounters with divinities and demons and previews of their own death. His wife, Lisa, said that, after his Friday session, he worked all weekend to make sense of the experience and write it down. Asked to state his intention, Mettes said that he wanted to learn to cope better with the anxiety and the fear that he felt about his cancer. As the researchers had suggested, he’d brought a few photographs along—of Lisa and him on their wedding day, and of their dog, Arlo—and placed them around the room.
At nine-thirty, Mettes lay down on the couch, put on the headphones and eye mask, and fell silent. In his account, he likened the start of the journey to the launch of a space shuttle, “a physically violent and rather clunky liftoff which eventually gave way to the blissful serenity of weightlessness.” Several of the volunteers I interviewed reported feeling intense fear and anxiety before giving themselves up to the experience, as the guides encourage them to do.
The guides work from a set of “flight instructions” prepared by Bill Richards, a Baltimore psychologist who worked with Stanislav Grof during the nineteen-seventies and now trains a new generation of psychedelic therapists. The document is a summary of the experience accumulated from managing thousands of psychedelic sessions—and countless bad trips—during the nineteen-sixties, whether these took place in therapeutic settings or in the bad-trip tent at Woodstock. The “same force that takes you deep within will, of its own impetus, return you safely to the everyday world,” the manual offers at one point. Guides are instructed to remind subjects that they’ll never be left alone and not to worry about their bodies while journeying, since the guides will keep an eye on them. Early on, Mettes encountered his brother’s wife, Ruth, who died of cancer more than twenty years earlier, at forty-three. You will need to contact the Driver and Vehicle Licensing Agency (DVLA) to inform them about your condition. The DVLA will contact your doctor for more information about how your condition is managed and whether you have any complications that might make you unsafe to drive.
Then he reached out and clutched Kalliontzi’s hand while pulling his knees up and pushing, as if he were delivering a baby.
I continued up to the apex of this shiny metal object and as I arrived, I had a choice, to look or not look, over the edge and into the infinite abyss.” He stared into “the vastness of the universe,” hesitant but not frightened. I had a headache.” When Lisa arrived to take him home, Patrick “looked like he had run a race,” she recalled. It’s the most rewarding day of your career.” Every guided psychedelic journey is different, but a few themes seem to recur. Many also described an encounter with their cancer that had the effect of diminishing its power over them.
Dinah Bazer, a shy woman in her sixties who had been given a diagnosis of ovarian cancer in 2010, screamed at the black mass of fear she encountered while peering into her rib cage: “Fuck you, I won’t be eaten alive!” Since her session, she says, she has stopped worrying about a recurrence—one of the objectives of the trial. Great secrets of the universe often become clear during the journey, such as “We are all one” or “Love is all that matters.” The usual ratio of wonder to banality in the adult mind is overturned, and such ideas acquire the force of revealed truth. The result is a kind of conversion experience, and the researchers believe that this is what is responsible for the therapeutic effect.
Subjects revelled in their sudden ability to travel seemingly at will through space and time, using it to visit Elizabethan England, the banks of the Ganges, or Wordsworthian scenes from their childhood. The impediment of a body is gone, as is one’s identity, yet, paradoxically, a perceiving and recording “I” still exists. Several volunteers used the metaphor of a camera being pulled back on the scene of their lives, to a point where matters that had once seemed daunting now appeared manageable—smoking, cancer, even death. Their accounts are reminiscent of the “overview effect” described by astronauts who have glimpsed the earth from a great distance, an experience that some of them say permanently altered their priorities. A woman I’ll call Deborah Ames, a breast-cancer survivor in her sixties (she asked not to be identified), described zipping through space as if in a video game until she arrived at the wall of a crematorium and realized, with a fright, “I’ve died and now I’m going to be cremated. The next thing I know, I’m below the ground in this gorgeous forest, deep woods, loamy and brown.
Carry diabetes identification and a letter from your doctor, and check with the airline you're flying with before you go. I was part of the earth.” Several patients described edging up to the precipice of death and looking over to the other side. Tammy Burgess, given a diagnosis of ovarian cancer at fifty-five, found herself gazing across “the great plain of consciousness. For one thing, most people’s recall of their journey is not just vivid but comprehensive, the narratives they reconstruct seamless and fully accessible, even years later. They don’t regard these narratives as “just a dream,” the evanescent products of fantasy or wish fulfillment, but, rather, as genuine and sturdy experiences.
This is the “noetic” quality that students of mysticism often describe: the unmistakable sense that whatever has been learned or witnessed has the authority and the durability of objective truth. This might help explain why so many cancer patients in the trials reported that their fear of death had lifted or at least abated: they had stared directly at death and come to know something about it, in a kind of dress rehearsal.
It’s one thing to conclude that love is all that matters, but quite another to come away from a therapy convinced that “there is another reality” awaiting us after death, as one volunteer put it, or that there is more to the universe—and to consciousness—than a purely materialist world view would have us believe. Bill Richards cited William James, who suggested that we judge the mystical experience not by its veracity, which is unknowable, but by its fruits: does it turn someone’s life in a positive direction? Many researchers acknowledge that the power of suggestion may play a role when a drug like psilocybin is administered by medical professionals with legal and institutional sanction: under such conditions, the expectations of the therapist are much more likely to be fulfilled by the patient.
He conceded that “authenticity is a scientific question not yet answered” and that all that scientists have to go by is what people tell them about their experiences. Just think about that for a second, that we are aware we’re aware!” Insofar as I was on board for one miracle well beyond the reach of materialist science, Griffiths was suggesting, I should remain open to the possibility of others.
Within these groups there are different types of insulin that work at different speeds and for different lengths of time in your body. There a thirty-four-year-old neuroscientist named Robin Carhart-Harris has been injecting healthy volunteers with psilocybin and LSD and then using a variety of scanning tools—including fMRI and magnetoencephalography (MEG)—to observe what happens in their brains. Carhart-Harris works in the laboratory of David Nutt, a prominent English psychopharmacologist.
Nutt served as the drug-policy adviser to the Labour Government until 2011, when he was fired for arguing that psychedelic drugs should be rescheduled on the ground that they are safer than alcohol or tobacco and potentially invaluable to neuroscience.
First, he took a graduate course in psychoanalysis—a field that few neuroscientists take seriously, regarding it less as a science than as a set of untestable beliefs. These should be injected about 15 to 30 minutes before meals and can last up to eight hours. Carhart-Harris was fascinated by psychoanalytic theory but frustrated by the paucity of its tools for exploring what it deemed most important about the mind: the unconscious. He set off to search the library catalogue for “LSD and the Unconscious” and found “Realms of the Human Unconscious,” by Stanislav Grof.
That set the course for the rest of my young life.” Carhart-Harris, who is slender and intense, with large pale-blue eyes that seldom blink, decided that he would use psychedelic drugs and modern brain-imaging techniques to put a foundation of hard science beneath psychoanalysis. He ran bureaucratic interference and helped secure funding (from the Beckley Foundation, which supports psychedelic research). When, in 2010, Carhart-Harris first began studying the brains of volunteers on psychedelics, neuroscientists assumed that the drugs somehow excited brain activity—hence the vivid hallucinations and powerful emotions that people report. The network comprises a critical and centrally situated hub of brain activity that links parts of the cerebral cortex to deeper, older structures in the brain, such as the limbic system and the hippocampus. The network, which consumes a significant portion of the brain’s energy, appears to be most active when we are least engaged in attending to the world or to a task.
It lights up when we are daydreaming, removed from sensory processing, and engaging in higher-level “meta-cognitive” processes such as self-reflection, mental time travel, rumination, and “theory of mind”—the ability to attribute mental states to others.
Carhart-Harris describes the default-mode network variously as the brain’s “orchestra conductor” or “corporate executive” or “capital city,” charged with managing and “holding the entire system together.” It is thought to be the physical counterpart of the autobiographical self, or ego.
You will learn to adjust your insulin dose yourself day-to-day so that your blood glucose levels stay stable. It appears that, with the ego temporarily out of commission, the boundaries between self and world, subject and object, all dissolve.
If the default-mode network functions as the conductor of the symphony of brain activity, we might expect its temporary disappearance from the stage to lead to an increase in dissonance and mental disorder—as appears to happen during the psychedelic journey. Regions that don’t ordinarily communicate directly with one another strike up conversations (neuroscientists sometimes call this “crosstalk”), often with bizarre results.
Carhart-Harris thinks that hallucinations occur when the visual-processing centers of the brain, left to their own devices, become more susceptible to the influence of our beliefs and emotions.
In his view, the forms of consciousness that psychedelics unleash are regressions to a more “primitive style of cognition.” Following Freud, he says that the mystical experience—whatever its source—returns us to the psychological condition of the infant, who has yet to develop a sense of himself as a bounded individual.
The pinnacle of human development is the achievement of the ego, which imposes order on the anarchy of a primitive mind buffeted by magical thinking. The mind is a “reducing valve,” he wrote, eliminating far more reality than it admits to our conscious awareness, lest we be overwhelmed.
Carhart-Harris has cited Huxley’s metaphor in some of his papers, likening the default-mode network to the reducing valve, but he does not agree that everything that comes through the opened doors of perception is necessarily real.



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