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FDA Approves First Digital Pill in Orwellian Nod to Big Pharma, Big Brother, Nanny State

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Monday night’s groundbreaking announcement of approval from the U.S. Food and Drug Administration marked a jaw-dropping tandem victory for the Nanny State and Big Pharma, in the form of a new pill embedded with a sensor, which can detect whether or not a patient took their medicine as prescribed — thus, opening a veritable Pandora’s Box of compliance, quality of care, cost, and more.

To what should be our collective astonishment, the policing of pharmaceuticals — the ability to deny medicine to patients with habitual difficulty keeping a schedule, cognizance of medical staff to a patient’s refusal to comply, and a portentous degree of control relinquished to infallible human decision-making — is now an untenable but distinct possibility.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, stated in a press release late Monday. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

Oddly, of all the conceivable medication types suitable for testing the technology, chosen was the antipsychotic prescription, Abilify — used in the treatment of schizophrenia, bipolar disorder, among other conditions — given to patients who frequently suffer delusions and paranoia which would drive them not to follow prescriptions all that reliably, nor be eager to swallow a sensor-laden pill.

Nevertheless, the first-of-its-kind digital medicine — by any measure, a breakthrough — removes, upon compliance, sovereign knowledge of one’s pharmaceutical regimen. Forbes reports,

“Abilify MyCite are aripiprazole tablets with sensors embedded in them. Once the pill goes down your hatch, the sensor can then send a message to a patch that you wear, essentially saying that ‘the pill has landed. Houston, we’ve reached the stomach.’ The wearable patch can then transmit this information to an app on your smart phone. From the smartphone, this information can go anywhere via the Interwebs, to, for instance, your family members or your doctors, granted that you give them permission to see this information. Otsuka Pharmaceutical Co., Ltd. makes the drug and Proteus Digital Health makes the sensor technology Abilify MyCite. …”

Before even touching on scanty possible benefits of a pill more befitting a conspiracy theorist’s worst nightmare, understand that — despite the digital pill’s initial rollout on a wholly voluntary and consensual arrangement between patients and physicians — an ingestible pill which can be tracked for beneficent reasons is an ingestible pill which can be tracked for less-than laudable, or even malevolent, reasons.

Unsurprisingly heralded by the Times as an advancement toward trimming astronomical pharmaceutical and healthcare costs, the outlet notes, “Experts estimate that so-called nonadherence or noncompliance to medication costs about $100 billion a year, much of it because patients get sicker and need additional treatment or hospitalization.”

Explains Dr. Paul Appelbaum, director of law, ethics and psychiatry at Columbia University’s psychiatry department, to the New York Times, “Many of those patients don’t take meds because they don’t like side effects, or don’t think they have an illness, or because they become paranoid about the doctor or the doctor’s intentions.”

Remarking on the peculiar choice in Abilify, he added, “A system that will monitor their behavior and send signals out of their body and notify their doctor?

“You would think that, whether in psychiatry or general medicine, drugs for almost any other condition would be a better place to start than a drug for schizophrenia.”

Beyond the incongruent testing sample, some in the psychiatric community worry the ramifications of such tracking may extend to the impoverished or those released on parole or myriad other situations in which medication compliance dictates one’s ability to receive assistance, but for whom maintaining a regular pill schedule — of the strictness inherent to digital tracking — might not be feasible.

Further still, although the sensor-embedded pills have proven effective mechanically, for their stated purpose, whether it actually improves compliance has yet to be substantiated.

“Is it going to lead to people having fewer relapses, not having unnecessary hospital readmissions, being able to improve their vocational and social life?” queried Dr. Jeffrey Lieberman, chairman of psychiatry at Columbia University and NewYork-Presbyterian Hospital, who affirms its general efficacy, particularly for patients evincing psychotic symptoms for the first time.

“There’s an irony in it being given to people with mental disorders than can include delusions,” he added. “It’s like a biomedical Big Brother.”

According to the Wall Street Journal, manufacturers of similar digital pills are expected to inundate the FDA, now that Abilify MyCite blazed a trail — with a concurrent rush to fit software to the nascent innovation.

How much time will pass, however, until a government agency, pharmaceutical company, or strained healthcare system develops a means to exploit the sensor-equipped pill into a punishment of some form remains the stuff of uncomfortable conjecture.


Image: Shutterstock/Xanya69.

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Stroke Victims to Be Given Psychedelic Drug DMT in First-Ever US Clinical Trials

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The hallucinogenic drug DMT (dimethyltriptamine) could provide crucial aid to stroke victims by minimizing the damage inflicted on victims’ brains as they are rushed to the hospital, according to researchers.

Canadian company Algernon Pharmaceuticals has laid out plans to microdose participants in the first clinical trial of its kind in hopes to help stroke victims’ brains recover faster through a “rewiring” process, reports Metro.

A stroke occurs when blood supplies to a part of the brain is drastically reduced or interrupted, starving the vital organ of fresh oxygen and nutrients and setting in motion the death of crucial nerve cells. In some cases, stroke can even lead to death. About 795,000 people suffer from strokes annually in the U.S.

However, researchers at Algernon argue that DMT could play a key role in staving off the worst effects of stroke by sparking the growth of new neurons, effectively turbo-charging the healing process.

In the first-ever clinical trials of this kind in the U.S., DMT will soon be administered to stroke patients in the back of ambulances. While the doses will be far too small to trigger any sort of hallucinations, scientists are claiming that the microdoses will still be sufficient for conferring benefits.

The Phase 1 trials could begin as soon as next month, if they receive a green light from authorities. It could still take years before the drug receives approval for human use.

Algernon CEO Christopher Moreau is hopeful that the drug will prove its ability to help heal the brains of those who suffer from a stroke.

“Since we’re dealing with stroke patients, we will be using the sub-hallucinogenic dose, which in pre-clinical studies has still shown to improve neuroplasticity,” Moreau explained.

“It will help the brain heal even though patients aren’t having the psychedelic experience, and we really don’t want that if your patient has just had a stroke,” he continued. “The sooner you can start to treat post-injury the better.”

However, the drug could likely have its limits.

“DMT may not benefit hemorrhagic (stroke victims), we don’t know, but we’re hoping it won’t cause them any problems because then we don’t have to wait for the CT scan, we can treat in the ambulance,” Moreau added.

DMT – also known as the “spirit molecule” for its extremely potent hallucinogenic properties – is one of the main psychoactive compounds found in ayahuasca, a brew consumed in shamanistic rituals that has been used for centuries in South America before finding its way into North America and Europe as a recreational drug popular at music festivals.

Experts and users of DMT have said that the drug has a similar impact to such other psychedelic drugs as LSD and psilocybin or “magic” mushrooms. However, the psychedelic experience or so-called “trip” from DMT is much shorter in duration than either of the other psychedelic drugs.

Studies of DMT have shown that it does have the ability to improve motor functions, and in tests on brain-damaged rats it helped trigger the formation of new brain cells.

Moreau claims that studies have shown that within hours of a stroke, the brain attempts to rewire itself – and that DMT may potentially accelerate the process.

At present, patients have little recourse in the immediate aftermath of a stroke because doctors seldom know what type of stroke someone may be suffering from. While ischemic strokes involving blood clots require blood thinner as treatment, hemorrhagic strokes require more invasive treatment.

However, the wrong type of treatment for a stroke could be fatal for patients.

Algernon hopes that if the first phase of trials prove successful, regulators will approve the more widespread usage of the treatment. In the second and third phases of the trial, Algernon hopes to continue DMT treatments over the short and long term to prove the efficacy of the treatment.

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U.S. Files Lawsuit Against Walmart for Role in Fueling Opioid Crisis

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In a new lawsuit filed by the U.S. Department of Justice, the Walmart corporation has been accused of helping to fuel the opioid crisis by knowingly filling out thousands of suspicious subscriptions and failing to report the orders to authorities. The DOJ says that the company could be facing billions of dollars in civil penalties if the court rules against them.

The lawsuit claims that Walmart was being investigated for years due to its lenient policy on opioid prescriptions. The company is being accused of violating the Controlled Substances Act (CSA) at its pharmacies and its wholesale drug distribution centers.

Walmart responded to the lawsuit and the allegations with a statement denying the charges, insisting that the lawsuit is based on “a legal theory that unlawfully forces pharmacists to come between patients and their doctors” and “cherry-picked documents taken out of context.”

The DOJ claims that Walmart “knowingly filled thousands of controlled substance prescriptions that were not issued for legitimate medical purposes.”

The company claimed that they did actually report cases to the DEA, and suggested that they were being blamed for the DEA’s own failures.

“In contrast to DEA’s own failures, Walmart always empowered our pharmacists to refuse to fill problematic opioids prescriptions, and they refused to fill hundreds of thousands of such prescriptions. Walmart sent DEA tens of thousands of investigative leads, and we blocked thousands of questionable doctors from having their opioid prescriptions filled at our pharmacies,” a statement from the company read, according to CNN Business.

This lawsuit is just the most recent of many actions that the DOJ has carried out against large corporations that played a role in the opioid crisis. Earlier this year, OxyContin producer Purdue Pharma pleaded guilty to three federal criminal charges for the role that it played in the ongoing opioid crisis.

Justice Department officials said that the company will be pleading guilty as part of a settlement worth over $8 billion. 

In the settlement, Purdue will pay $225 million directly to the government and will give up an additional $2 billion to the government through criminal asset forfeiture. The company also faces a $3.54 billion criminal fine, but this money may not be collected due to bankruptcy. Purdue also owes $2.8 billion in damages to cover lawsuits that victims have brought against the company.

The company will be pleading guilty to three federal charges, including conspiracy to defraud the United States and violating federal anti-kickback laws. The company admitted to pushing doctors to prescribe more opioids than they would have otherwise. Investigations into dozens of companies are currently ongoing, and more announcements are expected to come in the following months, with the potential of more charges against corporations that have yet to be named.

Some critics of the industry feel that the lawsuits do not go far enough, pointing out that most people would be facing harsh prison sentences if they were accused of selling drugs to the extent that these companies did.

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After This Mom Lost Her 1-Year-Old Son in a Car Crash, Health Insurers Left Her $175k of Debt

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(TMU) — It’s no exaggeration to say that the United States health care system is in the grips of a major crisis.

Despite the country being the wealthiest in the world, over 34 million people are uninsured while even more are underinsured. Thousands of Americans die of preventable illness every year while many struggle to afford their expensive prescriptions, yet U.S. health care remains a multi-billion dollar industry that rakes in major profits year after year.

And while the crisis has been reduced by mainstream media to an election year talking point—or an issue of “the market” versus “socialism”—the health care system has a life-and-death impact on Americans from all walks of life.

Such was the case for Michelle DuBarry, a Portland-based writer whose tragic experience with U.S. health care reveals all that’s wrong with a system that upholds corporate profits rather than human life.

When DuBarry’s 1-year-old son died after he was struck by a careless driver along with his father Eric, rather than being left to mourn she instead “sat at his bedside, his tiny, stitched-together body hooked to a million incessantly beeping machines, straining to recall what our deductibles were.”

Doctors had attempted to save the baby’s life but after two surgeries and one night in the ICU, he succumbed to his injuries. However, his death was only the beginning of a bereaved mother’s unimaginable ordeal at the hands of heartless health insurers and the bureaucracy that serves it.

https://twitter.com/DuBarryPie/status/1231669877628256256

DuBarry was already in dire straits because she was a new hire at her job and having worked less than a year in her position, she wasn’t comfortable taking days off. After all, if she lost this job then she could kiss her health insurance goodbye.

But a week hadn’t even passed before the hospital where she lost her son served her and her husband’s home with a lien. Having just lost their son, DuBarry and her husband now had to look at the possibility of losing their home.

In effect, the hospital was saying “Sucks that your son is gone, but we did our best – time to pay up!” Additionally, DuBarry’s husband couldn’t receive any treatment from his primary care doctor because not only would his supposedly “good” health insurance not cover it, but his doctor wouldn’t accept payment from the auto insurance company either.

https://twitter.com/DuBarryPie/status/1231669880736190465

Eventually, they only had to pay $5,000 following the death of their child and they still had a bit of cash from the auto insurance company on behalf of the reckless driver who killed the child. But once the health insurers realized that DuBarry and her husband got $175,000 from the auto insurance company, they did what any good predator would do: they sent their legal team to seize the funds leaving the grieving parents penniless.

https://twitter.com/DuBarryPie/status/1231669882573377537

DuBarry and her husband had no option to go on family and medical leave, so they did what good Americans are supposed to do: they went back to work toiling away to cover their mortgage and bills despite the catastrophic loss of their baby boy.

https://twitter.com/DuBarryPie/status/1231669884666273792

And while the Affordable Care Act, also known as “Obamacare,” is often touted as a major benefit to millions of people who would otherwise lack health insurance, it did precious little to help DuBarry and her husband after their devastating hospital visit.

DuBarry told her story on her personal website, explaining:

“In 2010, my husband Eric and our son Seamus were struck by a careless driver in a crosswalk near our home. Eric sustained minor injuries, and Seamus died the next day after enduring two surgeries and a night in intensive care. Our hospital bills totaled $180,000, and though most of it was covered by health insurance, we still had thousands of dollars in out-of-pocket medical expenses.”

They “soon learned that our health insurer was entitled to reimbursement out of these funds, effectively reducing our settlement to $0.” Due to these experiences, DuBarry began organizing to fight for a bill that would match the laws in many other states where the injured party is “made whole” for all damages from the at-fault party’s insurance prior to the injured party’s medical insurer getting paid. The bill was finally signed into law last June and DuBarry sees it as her late child’s legacy.

https://twitter.com/DuBarryPie/status/1231669886604075008

Michelle has now joined the growing legions of Americans demanding a universal healthcare system. While the plan has been lambasted by the right, as well as by Democratic Party bosses, many experts have hailed the plan as far more practical and less expensive than the status quo.

People across the globe were floored by DuBarry’s exceptionally American ordeal.

One Twitter user commented:

“In Canada, all that would have been free, and not only that, you wouldn’t have even needed to think about it. Our complete medical is paid from our taxes.”

While another wrote:

“All public health care is free in Australia. Can’t understand why USA unwilling to do the same. It’s just a cost the government meets.”

While Americans on both sides of the political divide—both “conservatives” and “liberals”—often revel in patriotic pride over the alleged greatness of the United States and the supposed “freedom” that citizenship offers, this woman and her husband found out that there simply is no choice under a private health care model. Instead, the health insurance industry is out to squeeze every last dollar from those who are suffering.

Why is it so hard for so many people to imagine a model where our health and happiness is protected rather than the profits of a small handful of health insurance corporations?

By Elias Marat | Creative Commons | TheMindUnleashed.com

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