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FDA Approves Ketamine Nasal Spray as Legal Antidepressant

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The US Food and Drug Administration (FDA) recently announced the approval of a ketamine-based nasal spray for treating depression. Ketamine is a strong sedative and dissociative that has been used in the veterinary and medical fields since the 1960s, but it has also been known as a club drug for nearly just as long. The fact that this medication is a nasal spray is a bit ironic, considering that the drug was often snorted when used at parties.

Numerous studies in recent years have shown that ketamine can be a good treatment option for major depression. Johnson & Johnson has developed a ketamine-based drug called esketamine, which has a slight chemical variation on the original substance. Once on the market, esketamine will be rebranded with the name Spravato.

Last month, an FDA panel voted 14-2 in favor of approving a nasal spray version of esketamine for cases of major depression where other medication has failed. The panel stipulated that patients would be required to have tried at least two other therapies before obtaining a prescription for esketamine.

Walter Dunn, who voted in favor of approval said:

“I think esketamine has the potential to be a game-changer in the treatment of depression … I use the term potential because the issues of cost and patient accessibility need to be addressed.”

Despite the overwhelming decision last month, it was unclear whether or not the FDA would actually take the advice of the panel and approve the medication due to the stigma associated with its illegal use.

Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said that the agency was impressed with how the drug performed in studies. In a press release Farchione said:

“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition. Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment. Because of safety concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient.”

The FDA granted esketamine both Fast Track and Breakthrough Therapy designations.

According to the press release:

“The Spravato labeling contains a Boxed Warning that cautions that patients are at risk for sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug. Because of the risk of sedation and dissociation, patients must be monitored by a health care provider for at least two hours after receiving their Spravato dose. The REMS requires the prescriber and the patient to both sign a Patient Enrollment Form that clearly states that the patient understands they should make arrangements to safely leave the health care setting to get home and that the patient should not drive or use heavy machinery for the rest of the day on which they receved [sic] the drug. Additionally, Spravato must be dispensed with a patient Medication Guide that outlines the drug’s uses and risks.

The patient self-administers Spravato nasal spray under the supervision of a health care provider in a certified doctor’s office or clinic, and the spray cannot be taken home. The health care provider will instruct the patient on how to operate the nasal spray device. During and after each use of the nasal spray device, the health care provider will check the patient and determine when the patient is ready to leave.”

To prevent the nasal spray from being used recreationally, a representative from Johnson & Johnson has said that the medication will not be sent home with patients, and can only be used under doctor supervision. Courtney Billington, president of Janssen Neuroscience, a subsidiary of Johnson & Johnson, says that very low doses will be administered in a professional setting.

“Spravato will not be dispensed directly to a patient to take at home. It will only be available in approved and certified treatment centers. The amount of active ingredient that’s in this product, it’s at a very, very low dose,” Billington said.

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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

Elias Marat

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Car Crash

(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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Same Big Pharma Empire Behind Opioid Epidemic Now Profiting From Overdose Cure

Elias Marat

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Big Pharma Opioid Epidemic Overdose Cure

(TMU) — An affiliate of the U.S.-based pharma company that brought us OxyContin, the blockbuster painkiller blamed for propelling opiate addiction to epidemic proportions, is now seeking to cash in by selling the cure to overdosing on the same drug.

While Purdue Pharma, the major pharma firm owned by the notorious Sackler family, is engulfed in a tidal wave of negative public opinion and lawsuits across the United States, its overseas affiliate Mundipharma has quietly expanded across the globe in a bid to monopolize the market for treating opioid overdoses, the Associated Press reports.

Mundipharma’s flagship product is a naloxone nasal spray called Nyxoid, which recently received approval from regulators in Europe, Australa, and New Zealand. The company’s European division has attempted to present the antidote as an important option for combating her*in overdoses, which remains a leading cause of overdose deaths across European countries.

With a cost of over $50 per dose in some European countries, the price of Nyxoid is far more expensive than her*in as well as injectable forms of naxalone. Similar nasal sprays have cost over $100 in the U.S., where opioid overdoses have claimed the lives of well over 400,000 people—a death toll that continues to climb as the opioid epidemic continues unabated.

Mundipharma has still been aggressively promoting the antidote at medical conferences. AP reports that at one conference, the company advertised the product with the slogan: “Be prepared. Get naloxone. Save a life.” 

Yet critics argue that the company that aggressively promoted OxyContin—fanning the deadly opioid addiction wave within the United States that eventually went worldwide—should be providing much cheaper, if not free, naloxone products.

Dr. Andrew Kolodny, a prominent critic of Purdue, told AP:

“You’re in the business of selling medicine that causes addiction and overdoses, and now you’re in the business of selling medicine that treats addiction and overdoses? That’s pretty clever, isn’t it?”

Lawsuits have also revealed how the massive complex of pharma firms owned by the Sackler family have sought to cash in on addiction treatments even while they pulled out all the stops in ensuring the proliferation of OxyContin. The company has denied that it has tried to profit from opioids and addiction treatment simultaneously.

However, in one internal document from Purdue uncovered in a Massachusetts lawsuit, an illustration showed a blue funnel with the top end labeled “pain treatment”—a reference to the opioids—and the bottom labeled “opioid addiction treatment.” The same presentation also said that the company had an opportunity to become an “end-to-end provider,” effectively manufacturing both the disease of widespread painkiller abuse and its cure.

According to the complaint, Purdue staff wrote:

“It is an attractive market … Large unmet need for vulnerable, underserved and stigmatized patient population suffering from substance abuse, dependence and addiction.”

Lawyers for the Sackler family have sought to cast blame for the secret plan, known as Project Tango, on a third-party equity fund. Yet Mundipharma’s efforts to promote naloxone bear a stunning resemblance to Purdue’s envisioned role as an “end-to-end provider.”

Stephen Wood, a fellow at Harvard Medical School Center for Bioethics who has researched how prices of naloxone products in the U.S. have escalated as the addiction crisis swelled, believes that the Sackler empire should make such antidotes widely available as a simple matter of ethics. He said:

“If they were trying to find a solution, they would just distribute naloxone for free.

They could use all that money they made off opioids to help support a program where they are giving away this life-saving medication.”

By Elias Marat | Creative Commons | TheMindUnleashed.com

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