The Brazen Way a Chinese Company Pumped Fentanyl Ingredients Into the U.S.

Yuancheng used an army of young, perky salespeople to peddle illegal chemicals to Americans.

https://amp.theatlantic.com/amp/article/596254/

Ye Chuan Fa works in a cubicle. His small station is indistinguishable from those of the hundreds of employees at his chemical company, Yuancheng, which translates roughly to “extended success.” Founded in 2001, Yuancheng employs about 700 people and has branch offices all over China.

While most of his workers appear to be in their 20s, Ye is in his 60s, thin with a sagging face. He’s a self-professed workaholic. “I get sick the minute I stop working,” he said in a 2007 Wuhan Morning News profile, which also referenced his great wealth without putting a number on it. His main focus today is Yuancheng, which sells chemicals both to the general public and to other businesses. It offers more than 10,000 different compounds, a vast and head-scratching list, everything from food additives (including synthetic versions of cinnamon) to pharmaceuticals (including the drugs used in Viagra and Cialis) to collagen, pesticides, veterinary products, anabolic steroids, and precursor chemicals used to synthesize drugs, including fentanyl.

According to Bryce Pardo, a fentanyl expert at the Rand Corporation, the two most commonly used fentanyl precursors—think of them as ingredients—are chemicals called NPP and 4-ANPP. When I first started researching them, in early 2017, advertisements for the chemicals were all over the internet, from a wide variety of different companies. Later, I determined that the majority of those companies were under the Yuancheng umbrella.

Over a period of a year, posing as an interested customer, I messaged with or spoke to 17 Yuancheng salespeople, sometimes for hours at a time. These were wide-ranging conversations that touched on the company’s products, practices, and working environment, and even the employees’ philosophies about selling such destructive chemicals. The salespeople called themselves names like Julie, Sean, and Demi, and, according to an article in the Changjiang Daily, were recruited in part for their English abilities. One salesman, the director of Yuancheng’s Shenzhen branch, told me that his Chinese name is Chen Li, but that as a salesman he goes by Abel. “Below 10 kilograms is express delivery, above 10 kilograms by air,” he said in October 2017 when asked how the NPP and 4-ANPP packages could be sent to the United States.

Read: Trump is using the opioid crisis to build his wall

“Food additives officially,” a Yuancheng saleswoman named Alisa said when I asked what products her company specializes in. “Steroids and 4-anpp npp underground.”

“Our products are sold to the United States less,” added Chen Li. “More is sold to Mexico.” This isn’t surprising, since most illicit fentanyl used in America, where 32,000 people died from fentanyl last year, comes through Mexico. Mexican cartels lack trained chemists to make fentanyl from scratch, so they buy precursors in bulk from China. After that, making finished fentanyl is simple.

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CVS, Rite Aid, Walmart severed from main opioid trial

https://www.chaindrugreview.com/cvs-rite-aid-walmart-severed-from-main-opioid-trial/

Judge grants order in effort to simplify the case

CLEVELAND — The federal  judge overseeing the landmark opioid suit Thursday severed CVS Health entities, Rite Aid and Walmart from the main bellwether trial scheduled for October.Judge Dan Aaron Polster of the United States District Court for the Northern District of Ohio granted the order to simplify the trial and make it more manageable. “Having fewer defendants in the first bellwether trial will allow plaintiffs to provide a more coherent presentation of the specific issues involved in the opioid crisis,” he wrote. He did not set a trial date for the severed defendants, which also include Anda Inc., Discount Drug Mart, HBC Service Co., H.D. Smith LLC, and Prescription Supply Inc.

At the outset of 2018, opioid lawsuits were being filed so frequently that a judicial panel grouped all the federal cases under the stewardship of Polster.  As of late January of this year, there were 1,548 cases, brought on behalf of millions of people.

Defendants in the case included pharmacy chains, which have come under scrutiny following the release of data by the federal government detailing the spread of the opioid epidemic. Last month, thousands of documents from companies across the pharmaceutical supply chain were filed in the case. Ranging from emails to shipping reports, the documents reveal the years-long spread of billions of pills around the country. Defendants in the suit also include drugmakers and distributors.

A CVS Health spokesman said after the data release,  “The plaintiffs’ allegations about CVS in this matter have no merit, and we are aggressively defending against them. We maintain stringent policies, procedures and tools to help ensure that our pharmacists properly exercise their professional responsibility to evaluate controlled substance prescriptions before filling them. Opioid medications are only a small percentage of the overall prescriptions our pharmacies dispensed.”

“Keep in mind that doctors have the primary responsibility to make sure the opioid prescriptions they write are for a legitimate purpose,” he added.

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Have Policies Designed to Mitigate Opioid Deaths Resulted in Unethical Treatment of Chronic Pain Patients?

https://www.medium.com/@mross109/have-policies-designed-to-mitigate-opioid-deaths-resulted-in-unethical-treatment-of-chronic-pain-4cdd235c7fc4

North American doctors are presently engaged in a giant medical and social experiment dictated by both the American and Canadian governments to reduce and lower opiates for chronic pain patients. It is hoped that this practice will reduce opioid overdoses and deaths but it has not. Prescriptions are way down but deaths continue to increase. Patients who have been on high doses of opioids, who have had little negative effects from those drugs and are doing well with good quality of life, are being forced by their doctors to reduce doses often with no discussion — against their will. Some are turning to the black market and others are deciding upon suicide.

These policies defy and run counter to all that modern society has deemed to be ethical in medical research.

If this experiment was being conducted by universities, it surely would be disallowed as all research on humans must first be approved by independent research ethics boards. Any research that resulted in an increase in suffering, disability, and/or deaths of human subjects would never be approved.

These research standards arose out of WWII when the full impact of Nazi atrocities came to light. Aside from genocide, some Nazi doctors engaged in human experiments that were cruel forms of torture.

After the Nuremberg Trials, the allied nations developed the Nuremberg Code with 10 important points. The ones most relevant to what is happening today are listed below with key points in bold.

1. The voluntary consent of the human subject is absolutely essential. Chronic pain patients are not asked for consent to taper but are forced.
2. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. Refusing to treat with opiates that have proven beneficial to a patient or to reduce them drastically will and is causing those patients unnecessary pain and suffering.
3. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. Patients who have been doing well are put at risk of becoming worse through forced tapering.
4. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. This is not being done as so many pain patients report that they have gone back to their doctor to tell them of the increased pain and suffering they are experiencing only to be ignored. In one case I am familiar with, the doctor decided to increase tapering despite the severe distress his patient was having. After the initial tapering, the patient reported increased pain and reduced functioning and the doctor told him he was going to reduce his dose even lower because the opioids were obviously not effective as he had pain. They were effective before he reduced them and then he used the increased pain caused by his lowering the dose to reduce further.
5. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. This experiment is being conducted by physicians rather than researchers.
6. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he[she] has reached the physical or mental state where continuation of the experiment seems to him[her] to be impossible. Patients are begging their doctors to stop tapering and to increase back to where they were doing well but doctors are refusing to do so.
7. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he[she] has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him[her] that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. This is not happening.

The Nurenberg Code is still considered to be the most important document in the history of the ethics of clinical research and led to the Declaration of Helsinki ratified by the World Medical Association. The notion of informed consent forms the basis of the UN Covenant on Civil and Political Rights. It also serves as the basis for the International Ethical Guidelines for Biomedical Research Involving Human Subjects proposed by the World Health Organization. Force tapering patients violates informed consent.

Every university has an Institutional Review Board which looks at research proposals and approves or rejects them based on these principles. No one can be recruited into a study unless the details of the study are fully explained to the subjects and they give their written consent. There are also requirements that if a patient gets worse or is harmed in anyway, the research is cancelled.

According to all of the above, it is reasonable to assert that chronic pain patients being forcibly tapered or denied their opiate medications and being severely harmed. This would never be approved in a university research setting but it is happening to patients every day.

The hypothesis that prescribing doctors and pain patients are the cause of the overdose crisis we are seeing is faulty and without validation in research. That is being proven over and over again as prescribing is significantly decreased but overdose deaths continue to soar. This was pointed out to Health Canada by the Chronic Pain Association of Canada. Health Canada has never responded.

The patients being harmed continue to be harmed and are powerless to stop this treatment. Some of these patients had been taking their medications with benefit and without incident for decades. There is simply no medical reason to interfere with their care and punish them with increased pain, disability and sometimes death.

The unethical treatment of patients has occurred in other instance such as the notorious “Tuskegee Experiment.” This was “an infamous and unethical clinical study conducted between 1932 and 1972 by the U.S. Public Health Service. The hidden purpose of this study was to observe the natural history of untreated syphilis; the African-American [only] men in the study were told that they were receiving free health care from the United States government.”

The “researchers knowingly failed to treat patients appropriately after the 1940s validation of penicillin was found as an effective cure for the disease that they were studying.” In other words, these men did not receive treatment for their syphilis which was left to progress for years as they suffered terribly and unnecessarily. We saw then a gross violation of the important points within the Declaration of Nuremberg.

Are we now watching history repeating itself?

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Study Confirms Cannabis Flower Is An Effective Mid-Level Analgesic Medication For Pain

https://www.news-line.com/PH_news29419_enews

Using the largest database of real-time recordings of the effects of common and commercially available cannabis products in the United States (U.S.), researchers at The University of New Mexico (UNM) found strong evidence that cannabis can significantly alleviate pain, with the average user experiencing a three-point drop in pain suffering on a 0-10 point scale immediately following cannabis consumption.

With a mounting opioid epidemic at full force and relatively few alternative pain medications available to the general public, scientists found conclusive support that cannabis is very effective at reducing pain caused by different types of health conditions, with relatively minimal negative side effects.

Chronic pain afflicts more than 20% of adults and is the most financially burdensome health condition that the U.S faces; exceeding, for example, the combined costs of treating heart disease and cancer.

“Our country has been flooded with an over-prescription of opioids medications, which then often leads to non-prescription opioid and heroin use for many people.

This man-made disaster is killing our families and friends, regardless of socio-economic status, skin tone, and other superficial human differences” said Jacob Miguel Vigil, one of the lead investigators of the study, titled “The Effectiveness of Self-Directed Medical Cannabis Treatment for Pain”, published in the journal Complementary Therapies in Medicine.

Vigil explains, “Cannabis offers the average patient an effective alternative to using opioids for general use in the treatment of pain with very minimal negative side effects for most people.”

The researchers relied on information collected with Releaf App, a mobile software program developed by co-authors Franco Brockelman, Keenan Keeling and Branden Hall. The app. enables cannabis users to monitor the real-time effects of the breadth of available cannabis-based products, which are always variable, of course, given the complexity of the Cannabis plant from which these products are obtained and use as a natural treatment for anxiety and many more.

Since its release in 2016, the commercially developed Releaf App has been the only publicly available, incentive-free app for educating patients on how different types of products (e.g., flower or concentrate), combustion methods, cannabis subspecies (Indica, Sativa, and hybrid), and major cannabinoid contents (THC and CBD) affect their symptom severity levels, providing the user invaluable feedback on their health status, medication choices, and the clinical outcomes of those choices as measured by symptom relief and side effects.

Scientifically, software like the Releaf App enables researchers to overcome the inherent limitations of government-funded clinical trials on the real-time effects of Cannabis, which are rare in general, but also often limited by onerous federal regulations, including its Schedule I status (no accepted medical use and a high abuse potential) and the mandate that investigators use the notoriously poor quality and low potency cannabis products supplied by the National Institute of Drug Abuse.

“Even just rescheduling cannabis just from Schedule I to Schedule II, i.e., classifying it with fentanyl, oxycodone, and cocaine rather than heroin and ecstasy, could dramatically improve our ability to conduct research and only would require that the DEA recognizes that accepted medical uses for cannabis exist, as clearly evidenced by our results and the flourishing medical cannabis programs in the majority of U.S. states,” pointed out co-author Sarah Stith.

Among the study’s findings the greatest analgesic responses were reported by people that used whole dried cannabis flower, or ‘buds,’ and particularly cannabis with relatively high levels of tetrahydrocannabinol, otherwise known as THC. The more recently popularized cannabinoid, cannabidiol or CBD, in contrast, showed little association with the momentary changes in pain intensity, based on the massive database explored in the study.

“Cannabis likely has numerous constituents that possess analgesic properties beyond THC, including terpenes and flavonoids, which likely act synergistically for people that use whole dried cannabis flower,” said Vigil, “Our results confirm that cannabis use is a relatively safe and effective medication for alleviating pain, and that is the most important message to learn from our results. Correct cbd dosage for ibs relieves one from stomach problems. It can only benefit the public for people to be able to responsibly weigh the true risks and benefits of their pain medication choices, and when given this opportunity, I’ve seen numerous chronic pain patients substitute away from opioid use, among many other classes of medications, in favor of medical cannabis.”

“Perhaps the most surprising result is just how widespread relief was with symptom relief reported in about 95 percent of cannabis administration sessions and across a wide variety of different types of pain,” added lead author of the study, Xiaoxue Li.

The authors do caution that cannabis use does carry the risks of addiction and short-term impairments in cognitive and behavioral functioning, and may not be effective for everyone. However, there are multiple mechanisms by which cannabis alleviates pain suffering. In addition to its anti-inflammatory properties, cannabis activates receptors that are colocalized with opioid receptors in the brain. “Cannabis with high THC also causes mood elevation and adjusts attentional demands, likely distracting patients from the aversive sensations that people refer to “pain,” explains Vigil.

“When compared to the negative health risks associated with opioid use, which currently takes the lives of over 115 Americans a day, cannabis may be an obvious value to patients. Chronic opioid use is associated with poorer quality of life, social isolation, lower immune functioning and early morbidity. In contrast, my own ongoing research increasingly suggests that cannabis use is associated with a reversal of each of these potential outcomes,” said Vigil

Source:University of New Mexico

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https://www.katv.com/community/7-on-your-side/pain-relief-out-of-reach

HOT SPRINGS (KATV) — Battling the opioid epidemic has caused some unintended casualties: chronic pain sufferers.

KATV traveled to Hot Springs to visit with a man who says he and his neighbors need help.

Reverend Dan Ash has lived with chronic pain since 1980 when he was in a bad car accident.

The 64-year-old lives in a Hot Springs apartment community specifically built and designed for the disabled.

Since the crackdown on opioids, he and many of his neighbors are suffering.

“My heart as a pastor…I’m concerned about all these folks here that hurt,” Ash said. “They’re hurting. I know…I know their medication has been taken away.”

As opioid abuse and overdose deaths attracted national attention, primary care physicians became more and more reluctant to prescribe opioids like hydrocodone, oxycodone, morphine, codeine, and fentanyl to anyone, including chronic pain sufferers.

“And the sad thing that breaks my heart is that they took it away from us,” said Ash. “Those of us who need it. There are many people out there who are suffering. And if you haven’t suffered from chronic pain it is like being in torture.”

Ash says he knows things had to change. Two years ago his nephew became part of the anti-opioid argument when he died of a heroin overdose.

But he says the pendulum has swung too far, causing some chronic pain sufferers to end their lives.

“Oh..the thought comes all the time,” says Ash. “Now I wouldn’t do it. Understand me…I would not do that. But I sometimes say, you know, there’s an easy way out of this. There’s an easy way. But when I had the fentanyl patches you don’t think that way.”

Ash says if a chronic pain sufferer has the x-rays and records and reports to prove they are in real pain that the drugs needed to control that pain should be prescribed.

The medical board allows doctors to prescribe opioids to chronic pain sufferers to levels up to 50 milligrams.

Ash says his last prescription was for only a 10-milligram dose.

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Pill Mills and the Opioid Epidemic

If you are or were a pharmacist or pharmacy manager for any of the chain pharmacies and you have information about inappropriate or fraudulent dispensing policies, please call us at 866-401-5971 or get started online to learn more about your potential rights.

https://www.baronandbudd.com/whistleblower/pill-mills

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You Don’t Have to Boycott CVS

The dispute over birth control has everything to do with corporate profits and little to do with health care.

www.slate.com/technology/2019/08/boycott-cvs-womens-health-corporate-profits.html

Somehow this week, CVS Caremark’s renegotiation with Pill Club, a mail-to-order birth control delivery service, ballooned into a feminist rights issue, with #CVSDeniesCare and #BoycottCVS trending on Twitter. But the negotiation at hand is not “an attack on women’s healthcare” as Laura Moser of Daily Action called it, nor are women being “financially punished,” as Ilyse Hogue of NARAL Pro-Choice America said. What’s being made out to be a big social justice issue is really not much more than a classic spat between businesses. In fact, far from necessitating a boycott of CVS, I’d suggest, the company’s pharmacy benefit manager is doing consumers a favor.

CVS Health, the eighth-biggest company in the United States, has two important business units: a chain of pharmacies, with which you are probably familiar, and their pharmacy benefit manager, CVS Caremark. Insurers turn to pharmacy benefit managers to help them negotiate lower prices for drugs. While insurers directly negotiate with hospital chains and doctor’s offices to determine the prices they’ll pay for medical procedures, it’s the PBMs that are negotiating with pharmacies to determine what the pharmacy will be reimbursed, along with what consumers’ copays for prescription drugs will be. Around 92 million Americans have CVS Caremark as their PBM—including a big subset of people with employer-based health insurance, people who bought individual plans on the exchange, and at least some people with Medicaid and Medicare Part D plans.

The feud started when CVS Caremark told Pill Club that when CVS Caremark customers bought birth control through Pill Club, CVS Caremark wouldn’t give Pill Club as much money as it used to. While the Affordable Care Act says that insurers have to cover most contraceptives without requiring a copay, this doesn’t dictate the way pharmacies are reimbursed. And it still should matter to consumers how much money the insurer pays the pharmacies for those drugs, because the more money the insurer pays out to pharmacies for prescription medicine, the higher health insurance premiums need to be to cover all those costs. Pill Club wouldn’t comment when I asked it how much it was reimbursed for birth control by CVS Caremark before the rate changes went into effect, or how much it’d be reimbursed after, citing confidential agreements with CVS, but Ali Hartley, vice president of legal and compliance for Pill Club, did say the pricing changes made it “impossible for Pill Club to effectively serve its members.”

The outrage levied at CVS Caremark was largely a response to Pill Club’s own effective rousing of frustration at the idea that a company would pay less for birth control. But there was no moral stance at play here—this was a business negotiation. The goal of any PBM like CVS Caremark is to win contracts with insurers by promising they can negotiate good deals with pharmacies. If they tell pharmacies like Pill Club, Rite Aid, or Walmart, “We used to give you $1 per pill for this drug, but now we’re only going to give you 80 cents,” they’re doing so to curry favor with the insurers, who won’t have to spend as much money as they were spending before. If the PBM tries to set reimbursement rates too low, the pharmacy can walk away from the deal and not work with the PBM anymore, which is what Pill Club is threatening to do. That would mean CVS Caremark customers would no longer have their insurance accepted by Pill Club. If too many pharmacies balk at CVS Caremark reimbursement rates, customers will get fed up when they realize their insurance is only accepted at a few pharmacies and try to switch plans. It’s a delicate juggling act, but it’s one we want CVS Caremark and other PBMs to be playing: If they don’t put pressure on drug prices, health insurance will be even more expensive than what it is today.

As Frank Sloan, the J. Alexander McMahon professor emeritus of health policy and management at Duke University, pointed out to me by phone, PBMs can be an “easy target” for criticism, since they’re not directly providing patient care. But if insurance companies thought they could do a better job of negotiating prices, they’d have already taken on that role themselves. And remember, the people who are suffering as a result of CVS Caremark’s decision aren’t the consumers—it’s the company that sells pills for profit. Pill Club will make a little less profit now, which is why it’s upset.

Most important for consumers is the fact that even if Pill Club decides to stop serving CVS Caremark customers, you will still be able to get your birth control delivered for free. There are multiple options for birth control delivery through CVS Caremark. Simple Health delivers birth control to all 50 states. (Like Pill Club, Simple Health doesn’t charge a delivery fee, but it does charge a $20 consultation fee to get started, which in 20 states can include getting a prescription for birth control if you don’t already have one. A spokesperson further told me by Twitter it’s “quick to waive the fee for people based on personal need.”) PillPack, an Amazon company, also charges no delivery fee for customers who want prescriptions mailed to their door. It’s also in network with CVS Caremark, and its spokesperson told me by email that it expects to remain so.  And of course, CVS Caremark is happy to do the delivery itself—shipping is free with CVS Caremark’s mail-order delivery service, although it’s worth mentioning that CVS Pharmacy also runs same-day to two-day delivery service from individual pharmacy locations, where it charges rates up to $9.

If Simple Health, Pill Pack, and CVS Caremark’s own delivery services keep shipping birth control to customers’ doors for free, it’s hard to argue there’s a real issue of “access” here. When it comes to reproductive health, the outcomes will be the same whether the pills come from the Pill Club, CVS Caremark, or Santa Claus. Pill Club does include freebies like chocolate or organic tampons in its deliveries, which may be something consumers miss, but again, it’s not a health issue. But when it comes to the CVS–Pill Club fight, it’s really corporate profits, not women’s health, that’s on the line.

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The FBI is probing the pot industry, but not for the reason you might expect

https://www.foxbusiness.com/industrials/fbi-probing-pot-industry-reason

Could public corruption be threatening the state-legal marijuana industry?

FBI officials said in a recent podcast that state licenses required to grow and sell marijuana open the possibility of public officials becoming susceptible to bribes in exchange for those licenses.

“We’ve seen in some states the price go as high as $500,000 for a license to sell marijuana,” Supervisory Special Agent Regino Chavez said. “So, we see people willing to pay large amounts of money to get into the industry.”

States with decentralized licensing are at the greatest risk of corruption, authorities said.

The legal status of cannabis remains iffy, even in states that have passed laws legalizing medical and recreational pot. The federal government still considers marijuana illegal, with the DEA listing it as a Schedule I drug — meaning officials believe it has a high potential for abuse.

Having the FBI investigating improper conduct related to the industry — but not businesses playing by the rules — is “de facto recognition for us,” California cannabis attorney Henry Wykowski, a former federal prosecutor, told Marijuana Business Daily this week.

“It’s part of a trend,” he said. “As cannabis becomes more mainstream, all these different groups that have ignored us in the past are starting to pay attention to us.”

Government agencies have also been looking into antitrust issues, CBD medical claims and cannabis companies’ ability to file for bankruptcy, according to the report.

Wykowski told MBD the marijuana industry is entitled to the same protections other industries receive.

The feds aren’t the only ones looking at illegal activity in the legal pot business. California has tripled the number of raids on unlicensed marijuana shops this year, the Los Angeles Times reported earlier this summer. Unlicensed growers in the state face fines of up to $30,000 per day.

David Kirschner, an intelligence analyst with the FBI, said states should expect marijuana-related corruption to increase as recreational pot becomes more widespread.

“It’s our role as the FBI to help ensure that the corruption doesn’t spread in this new industry,” he said.

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William R. Bauer, MD, 82, a neurologist in Port Clinton, OH with over 50 years of experience was indicted

www.doctorsofcourage.org/william-r-bauer-md/

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