FDA Designates MDMA As ‘Breakthrough Therapy’ For Post-Traumatic Stress

https://www.forbes.com/sites/janetwburns/2017/08/28/fda-designates-mdma-as-breakthrough-therapy-for-post-traumatic-stress/#5f9d34e67460

Following years of lobbying and laboratory research on the medical uses of methylenedioxymethamphetamine, or MDMA, the U.S. Food and Drug Administration has decided to move forward with the drug.

Last week, the Multidisciplinary Association for Psychedelic Studies (MAPS) announced that the FDA has granted Breakthrough Therapy Designation to MDMA for the treatment of post-traumatic stress disorder (PTSD). Popularly known as a recreational drug, and as the main ingredient in ecstasy, MDMA has been shown to offer significant relief for sufferers of PTSD in clinical use trials conducted over the past several years, leading to the U.S. agency’s decision.

MAPS, which has been championing and fundraising for MDMA research for roughly 30 years, explained in a press release that the FDA’s granting of a Breakthrough Therapy Designation indicates the agency “has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD.” It also designates the agency’s intent to help develop and review the treatment faster than other candidate therapies. 

See also: Cannabis Shows Promise In Treating Schizophrenia And Tourette Syndrome

 

According to MAPS, the non-profit organization has reached an agreement with the FDA under the Special Protocol Assessment Process for the design of two Phase 3 trials for MDMA-assisted psychotherapy for patients with severe PTSD in the near future.  

“Reaching agreement with [the] FDA on the design of our Phase 3 program and having the ability to work closely with the agency has been a major priority for our team,” said Amy Emerson, Executive Director of the MAPS Public Benefit Corporation, in a release. “Our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly. With breakthrough designation, we can now move even more efficiently through the development process in collaboration with the FDA to complete Phase 3.”

 

National Institute on Drug Abuse

An illustration depicts how MDMA affects brain chemistry by binding to serotonin transporters, causing natural serotonin to temporarily flood the brain. (Public Domain courtesy National Institute on Drug Abuse via Wikimedia Commons)

The drug’s ability to help PTSD-sufferers cope with the lingering effects of trauma is attributed in large part to its capacity to produce feelings of euphoria, empathy, and heightened emotional and physical sensations–in other words, perhaps, giving sorely stressed brains the kind of neurochemical getaway that begets a little peace of mind. Those effects also seem to motivate recreational users, but unlike the self-dosed Saturday night version, official MDMA-assisted psychotherapy involves three administrations of the drug combined with established psychotherapeutic techniques.

Rick Doblin, Founder and Executive Director of MAPS, commented in a statement, “For the first time ever, psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way … Now that we have agreement with FDA, we are ready to start negotiations with the European Medicines Agency.”

In Phase 2 trials completed by MAPS, 61% of the 107 participants no longer qualified for PTSD two months after they underwent three sessions of MDMA-assisted psychotherapy, according to the group. After a year, that number grew to 68%, and among participants who had all suffered from chronic, treatment-resistant PTSD, on average for 17.8 years. 

See also: Global Survey Says Magic Mushrooms Are The Safest Recreational Drug

The randomized, placebo-controlled Phase 3 trials will assess the efficacy and safety of MDMA-assisted psychotherapy in a group of 200 to 300 participants with PTSD aged 18+ at sites in the U.S., Canada, and Israel. As Science reported, the trials could begin as soon as next spring and wrap up by 2021 if MAPS is able to find the estimated $25 million needed to conduct them.

As Science reflected, “That an illegal dancefloor drug could become a promising pharmaceutical is another indication that the efforts of a dedicated group of researchers interested in the medicinal properties of mind-altering drugs is paying dividends.”

David Nutt, a neuropsychopharmacologist at Imperial College London, told Science, “This is not a big scientific step … It’s been obvious for 40 years that these drugs are medicines. But it’s a huge step in acceptance.”

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Critical CVS App Flaw Shared Private User Data on 40+ Servers

www.idropnews.com/news/critical-cvs-app-flaw-shared-user-data-on-40-web-servers/48075/

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Aetna hit with lawsuit over HIV-status privacy breach

http://www.fiercehealthcare.com/payer/aetna-hit-lawsuit-over-hiv-privacy-breach

Aetna is facing a class-action lawsuit filed on behalf of customers who claim their privacy was breached when they received a letter containing a reference to filling HIV medications that was visible through a window in the envelope. 

The issue came to light last week when two advocacy groups—the Legal Action Center and AIDS Law Project of Pennsylvania—issued a statement outlining the complaints they’ve received from Aetna customers who claim the mailings were seen by family members, roommates and neighbors. 

In response, Aetna issued a public apology and said it is “undertaking a full review of our processes to ensure something like this never happens again.” The insurer had also sent a letter to the 12,000 members who received the letters notifying them of the breach and their rights.

Now, though, the gaffe is a legal matter. Philadelphia-based law firm Berger & Montague filed a complaint (PDF) against Aetna on Monday in the U.S. District Court for the Eastern District of Pennsylvania, demanding that the company cease the practice, reform its procedures and pay damages. The lead plaintiff in the case, according to an announcement (PDF), is a Bucks County, Pennsylvania, man whose sister learned from seeing an Aetna letter that her brother was taking medications to prevent acquiring HIV. 

“My law firm and the nonprofit legal organizations with whom we are working believe that the best way to ensure a remedy for the people who received the letters, and suffered harm, is to file a class action suit,” said Sarah Schalman-Bergen, a Berger & Montague shareholder. “We are committed to prosecuting this matter and making sure that this never happens again.”

Indeed, the lawsuit noted that this isn’t the first time Aetna customers have complained about privacy issues related to their HIV prescriptions. Previously, the insurer settled cases brought by members who claimed its policy requiring them to fill HIV medications through mail order, rather than at a pharmacy, jeopardized their privacy. 

Thus, Aetna changed its policy and notified the affected members. But in doing so, it used a third-party mailing vendor, which sent the notices in an envelope with a “large transparent glassine window,” which in some cases made the instructions for how to fill HIV medications visible without having to open the letter.

These actions, the lawsuit said, “carelessly, recklessly, negligently and impermissibly” revealed HIV-related information of Aetna’s current and former members to their “family, friends, roommates, landlords, neighbors, mail carriers and complete strangers.”

When reached by email, an Aetna spokesman said the company had no comment on the lawsuit.

At least one state official, meanwhile, has also expressed concern about the privacy breach. New York Attorney General Eric Schneiderman tweeted last week that he sent a letter to Aetna asking for more information:

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The Lead Vaccine Developer Comes Clean So She Can “Sleep At Night”

www.realfarmacy.com/the-lead-vaccine-developer-comes-clean/

Gardasil and Cervarix don’t work, are dangerous, and weren’t tested

Dr. Diane Harper was the lead researcher in the development of the human papilloma virus vaccines, Gardasil and Cervarix. She is the latest to come forward and question the safety and effectiveness of these vaccines. She made the surprising announcement at the 4th International Public Conference on Vaccination, which took place in Reston, Virginia on Oct. 2nd through 4th, 2009. Her speech was supposed to promote the Gardasil and Cervarix vaccines, but she instead turned on her corporate bosses in a very public way. When questioned about the presentation, audience members remarked that they came away feeling that the vaccines should not be used.

“I came away from the talk with the perception that the risk of adverse side effects is so much greater than the risk of cervical cancer, I couldn’t help but question why we need the vaccine at all.”  – Joan Robinson

Dr. Harper explained in her presentation that the cervical cancer risk in the U.S. is already extremely low, and that vaccinations are unlikely to have any effect upon the rate of cervical cancer in the United States. In fact, 70% of all H.P.V. infections resolve themselves without treatment in a year, and the number rises to well over 90% in two years. Harper also mentioned the safety angle. All trials of the vaccines were done on children aged 15 and above, despite them currently being marketed for 9-year-olds. So far, 15,037 girls have reported adverse side effects from Gardasil alone to the Vaccine Adverse Event Reporting System (V.A.E.R.S.), and this number only reflects parents who underwent the hurdles required for reporting adverse reactions. At the time of writing, 44 girls are officially known to have died from these vaccines. The reported side effects include Guillian Barré Syndrome (paralysis lasting for years, or permanently — sometimes eventually causing suffocation), lupus, seizures, blood clots, and brain inflammation. Parents are usually not made aware of these risks. Dr. Harper, the vaccine developer, claimed that she was speaking out, so that she might finally be able to sleep at night.

“About eight in every ten women who have been sexually active will have H.P.V. at some stage of their life. Normally there are no symptoms, and in 98 per cent of cases it clears itself. But in those cases where it doesn’t, and isn’t treated, it can lead to pre-cancerous cells which may develop into cervical cancer.”  – Dr. Diane Harper

One must understand how the establishment’s word games are played to truly understand the meaning of the above quote, and one needs to understand its unique version of “science”. When they report that untreated cases “can” lead to something that “may” lead to cervical cancer, it really means that the relationship is merely a hypothetical conjecture that is profitable if people actually believe it. In other words, there is no demonstrated relationship between the condition being vaccinated for and the rare cancers that the vaccine might prevent, but it is marketed to do that nonetheless. In fact, there is no actual evidence that the vaccine can prevent any cancer. From the manufacturers own admissions, the vaccine only works on 4 strains out of 40 for a specific venereal disease that dies on its own in a relatively short period, so the chance of it actually helping an individual is about about the same as the chance of him being struck by a meteorite. Why do nine-year-old girls need vaccinations for extremely rare and symptom-less venereal diseases that the immune system usually kills anyway?

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Someone has asked for some help in spreading Walmarts new directives. Many Walmart Rphs are in the mid to high 60’s per hour pay rate. The new goal is to have pharmacy managers at 55 per hour and staff at 52 per hour. This info came from a market manager that was at meeting in Arkansas last week. They are not terminating people for the usual business metrics like the three letter chain or for immunization metrics, but rather policy and procedures. The biggest area for terminations is coming from pharmacists using the restroom. Most Walmarts have a restroom within the gated area, however according to the policy and procedures below this leaves the pharmacy unattended and out of sight.The policy and procedures trump state laws that require a RPh to be in the building….according to Walmart they need to have the pharmacy in sight. One such Pharmacist was more than 3 feet out of the OTC section while helping a patient and was fired. Bathroom breaks are only at lunch when the pharmacy is closed. If you can help in any way it would be greatly appreciated. Many have been terminated for the bathroom thing and of course were replaced with someone will to take much less pay. Just like at CVS I’m sure most don’t review these policies to often.

click on above graphic to pull up new policies and procedures

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CLICK ON ABOVE LINK TO LISTEN

This American War on Drugs

Attorney General Jeff Sessions has signaled that he’d like to revamp the war on drugs. We take a look at the history of the battle, and how sensational media depictions of crack, heroin, and meth have helped fuel it. Plus: our Breaking News Consumer’s Handbook: Drugs Edition. Then, a look at how America’s first drug czar used racist propaganda to outlaw marijuana. And why the debate between treatment and law enforcement is blurrier than you might think. 1. Our Breaking News Consumer’s Handbook: Drugs Edition: a critical look at what the press gets wrong about drugs and drug addiction, featuring Dr. Debbie Dowell of the Centers for Disease Control and Prevention, Dr. Carl Hart of Columbia University, and author Maia Szalavitz. 2. Historian Alexandra Chasin and author Johann Hari tell the story of Harry Anslinger, the man who set our seeming eternal drug war in motion, and his ruthless pursuit of jazz singer Billie Holiday. 3. University of California Santa Cruz’s Dr. Craig Reinarman examines how American presidents encouraged and harnessed hysteria around drugs for political gain. 4. Journalist Sam Quinones argues for the importance of aggressive policing in the effort to end America’s opioid crisis.

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Intent On Reversing Its Opioid Epidemic, A State Limits Prescriptions

http://www.npr.org/sections/health-shots/2017/08/23/543955887/intent-on-reversing-its-opioid-epidemic-a-state-limits-prescriptions

A year ago, Maine was one of the first states to set limits on opioid prescriptions. The goal in capping the dose of prescription painkillers a patient could get was to stem the flow of opioids that are fueling a nationwide epidemic of abuse.

Maine’s law, considered the toughest in the U.S., is largely viewed as a success. But it has also been controversial — particularly among chronic pain patients who are reluctant to lose the medicine they say helps them function.

Ed Hodgdon, who is retired and lives in southern Maine, was just that sort of patient — at least initially.

Name a surgery, and there’s a decent chance Hodgdon has had it.

“Knee replacement. Hip replacement. Elbows. I’ve got screws in my feet,” he says.

 

Hodgdon has rheumatoid arthritis. And along with each surgery came an opioid prescription for pain. At first he got some relief from the drugs, but it didn’t last.

“It just numbed it for a while,” he says, “and then I needed more.”

Though Hogdon kept increasing the dose, the pain never went away.

“And then I found Dr. Medd. That’s my angel right there,” Hodgdon says, nodding toward Dr. Donald Medd, a general internist in Westbrook.

Medd had already started to taper high doses among patients like Hodgdon before Maine put a cap on new prescriptions for opioids last July. The new limit allows a maximum of 100 morphine milligram equivalents (the standard used to measure potency for all prescription opioids) for most patients per day — with certain exemptions for some cancer patients, those in hospice care, and some others. Patients with existing prescriptions were, by and large, given a year to meet the new restriction.

Medd was ahead of the game because he’d noticed that many of his patients on high doses of opioids grew increasingly angry about their pain as time wore on, and tended to demand ever more medication. At the same time, they were struggling to function in daily life because of the drugs’ side effects.

“You know, at some point the medications get in the way of some sort of recovery,” Medd says.

Opioids were affecting Hodgdon’s mood and his memory. Medd worked with him to cut the dose he was taking every day by two-thirds and helped him get in touch with a psychologist for further help. Though Hodgdon still lives with some pain, he says his life is infinitely better.

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From Alaska To Florida, States Respond To Opioid Crisis With Emergency Declarations

“I can remember things,” he says. “I get along better with people.”

Despite success stories like Hodgdon’s, Medd says he initially opposed Maine’s law. He didn’t want the legislature to interfere with medicine.

But now he thinks the law gave a necessary nudge to many doctors. Compared to a few years ago, Medd says, he and colleagues in his medical practice have cut the number of their chronic pain patients who are on opioids by almost half — from about 1,500 to 800.

In nearly all counties in the state, the number of prescriptions for painkillers is dropping. It’s a trend that Gordon Smith, executive vice president of the Maine Medical Association, says was underway even before the law took effect.

“We had the fourth largest drop in the country,” he says, citing a 21.5 percent reduction in opioid prescriptions from 2013 through 2016.

The data only include the first few months after Maine’s prescribing cap went into effect, Smith says; he expects the law will accelerate further reductions.

Shots – Health News

Opioid Prescriptions Falling But Remain Too High, CDC Says

“Now having said that, it’s not been easy,” he says. “It’s been particularly difficult for patients,” he says — specifically for the 16,000 patients on high-dose opioids who were expected to taper to the 100 morphine milligram limit by July of this year.

 

“I was about four times above that,” says Brian Rockett. He operates a wholesale business buying lobsters on the Maine coast. Rockett started taking opioids years ago to ease the pain of injuries from racing motorcycles and boats. When he tried to taper the dose, he says, he had unbearable pain. So, he filed a notice of intent to sue the state over its restrictions on how much he could be prescribed.

“I just knew that I was facing possibly losing my business,” he says.

Rockett wasn’t alone in his inability to taper his use of the drug, and Maine lawmakers — like Dr. Geoffrey Gratwick, a state senator who is also a rheumatologist — took notice.

Shots – Health News

A Drugmaker Tries To Cash In On The Opioid Epidemic, One State Law At A Time

“A certain group of people simply cannot come off [opioids],” Gratwick says.

He recently pushed through a change to Maine’s law that allows broader exemptions, so that people with incurable, chronic conditions can continue to take high doses.

It put the decision about that back in the hands of the doctor and patient, Gratwick says, “where it should be.”

Under the revised law, Rockett was able to increase his dose, and dropped his lawsuit.

Even though more patients could, potentially, seek exemptions, Maine’s law is seen by its advocates as an important step. Recent data from the federal Centers for Disease Control suggest that nationwide, despite an overall decrease in recent years, the number of opioids prescribed still triple what it was in 1999.

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Is Medicaid fuelling the opioid crisis?

http://www.americanthinker.com/blog/2017/08/is_medicaid_fuelling_the_opioid_crisis.html#.WaLj3FFxk_4.blogger

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