Tag Archives: opioid crisis

Big Pharma Bribes Linked To Doctors Prescribing Large Quantities Of Opioids

(DCNF) Major pharmaceutical companies heavily influenced doctors to prescribe high rates of opioid medications with lavish spending, new research suggests.

Doctors, who received paid speaking gigs, free lunches and branded merchandise from drug makers, were linked to much high rates of opioid prescriptions, a research letter published Monday in the the Journal of the American Medical Association’s JAMA Internal Medicine found. In 2014, every free meal given to a doctor from pharmaceutical companies resulted in a spike of opioid prescriptions from the doctor, the study authors, lead by Dr. Scott Hadland of the Boston University School of Medicine, concluded, according to NBC News.

Insys Therapeutics, a fentanyl manufacturer currently mired in federal investigation, spent the most of any drug maker on various payments to physicians. Opioid prescriptions rose an average of nine percent when a doctor received payments from the pharmaceutical industry, the researchers estimated.

“Amidst national efforts to curb the overprescribing of opioids, our findings suggest that manufacturers should consider a voluntary decrease or complete cessation of marketing to physicians,” Hadland said, according to NBC News. “Federal and state governments should also consider legal limits on the number and amount of payments.”

OxyContin maker Purdue Pharma, which often faces the brunt of criticism over the opioid epidemic, ended their marketing practice of promoting painkillers to health care professionals in February.

Outside of Insys, however, the biggest spenders on promotion to doctors are Teva Pharmaceuticals and Johnson & Johnson’s Janssen Pharmaceuticals, according to the researchers.

Insys, which produces a fentanyl patch, Subsys, for cancer patients, is currently facing lawsuits in multiple states for illegally bribing doctors to unnecessarily push the dangerous medication. Seven former Insys executives and managers are battling allegations in Boston. John Kapoor, the billionaire founder of Insys, is also under investigation for allegedly personally directing the company’s bribery schemes.

Insys defrauded insurance companies by giving payouts to doctors who overprescribed Subsys or prescribed it for unapproved conditions, including through fees for fake speaking engagements, the lawsuits claim.

Fentanyl, a synthetic opioid roughly 50 to 100 times more powerful than morphine, overtook heroin as the deadliest substance in the U.S. in 2016, claiming 19,413 lives in 2017, according to data from the Centers for Disease Control and Prevention.

Drug overdoses are now the leading cause of accidental death for Americans under age 50, killing more than 64,000 people in 2016. Opioid overdoses made up a staggering 66 percent of all drug overdose deaths in 2016, surpassing the annual number of lives lost to breast cancer.

Written by Steve Birr. Follow Steve on Twitter

 

This article was republished with permission from the Daily Caller News Foundation.

DEA Knowingly Let Admitted Addicts, Dealers Prescribe Drugs

(DCNF) Admitted drug addicts and dealers were among the hundreds of thousands of people and businesses the Drug Enforcement Administration (DEA) licensed to manufacture, distribute or prescribe pharmaceuticals over the past 12 years, a Daily Caller News Foundation investigation has found. The agency stripped only 240 licenses for wrong-doing over the same period.

The DEA’s Office of Diversion Control, which is responsible for issuing and revoking the permits, is, by law, fully funded by the licenses’ application fees. More than 1.7 million individuals and organizations held licenses as of March 2018 — an increase of more than 510,000 since August 2006, the earliest publicly available data, TheDCNF’s review found.

“The office … has not been very aggressive in hunting down doctors [who] are prescribing in inappropriate ways,” said Carnegie Mellon University Professor Jonathan Caulkins, who’s worked extensively in drug policy. “The DEA does not aggressively try to find corrupt or incompetent health care providers in the health care system.”

Effective enforcement is especially important given the growing opioid epidemic, Caulkins added. More than 200,000 Americans died from prescription drug overdoses between 1999 and 2016, according to the Centers for Disease Control and Prevention. Most heroin users begin their addiction with such prescriptions, studies have shown.

The DEA ruled on 430 investigations into licensed individuals and groups since March 2006. The agency only revoked 240 licenses and denied applications for another 106, according to a DCNF review of the investigations.

“It is not really believable from my perspective that if they had proper enforcement … that that number [of revocations] would be so low,” Public Citizen’s Health Research Group Founder and Senior Adviser Sidney Wolfe told TheDCNF. “We don’t have adequate, serious law enforcement that musters all of the evidence they have and then acts appropriately. If we did, that number would be in the thousands.”

Most states maintain databases with information about how prescription drugs are dispensed, Wolfe also noted.

“I would bet DEA itself does not collect the data from these states that could be useful in deciding if it’s safe to re-register someone,” Wolfe added. “It’s poor law enforcement. These are crucial, life-challenging things that are going on.”

Meanwhile, the DEA gave out licenses to people who admitted to having been addicted to or dealt drugs in the past.

One dentist, for example, admitted to helping “an outlaw motorcycle gang” manufacture methamphetamine in the early 2000s, which resulted in two years of jail time, a DEA document said. He’d previously been caught with meth several times and admitted to “a history of substance abuse with alcohol, marijuana, methamphetamine and cocaine.”

The DEA gave him a license to prescribe certain drugs in September 2013.

A doctor was caught distributing cocaine in 1981 but wasn’t prosecuted because he cooperated with authorities, another DEA document shows. He was arrested again in 2001 with cocaine and two prescription drugs — an opioid and a minor tranquilizer — and pleaded guilty to related charges in 2003.

The DEA gave him a license to prescribe drugs in February 2009.

“The number of doctors themselves [who] have opioid problems is probably higher than the number of [revocations],” Wolfe told TheDCNF. “If you have an opioid addiction, the last thing you should be doing is prescribing opioids.”

However, “doctors have a relatively high risk of addiction” and there is rehabilitation specifically designed for physicians, Caulkins said.

Also, 72 percent “of all substances identified in physician arrests since 2003 were opioids,” according to a recent Detox.net study that analyzed DEA data.

Government watchdogs have also repeatedly criticized the DEA’s Office of Diversion Control.

Even when the DEA revokes a license or denies an application or renewal, the decision-making process can be lengthy, the Department of Justice’s inspector general (IG) found in 2014. It took the agency an average of nearly two years to make a final decisions on cases in 2009, though that decreased to just one year by 2012.

“Such delays can create risks to public health and safety by allowing noncompliant registrants to operate their business or practice while the registrant action is being adjudicated,” the IG wrote. For example, a doctor can keep writing prescriptions — even after the DEA proposed revoking his license — until a ruling is made.

Just one doctor prescribing medications in an abusive manner could harm hundreds of patients, according to Wolfe.

Just one percent of special agents’ investigative time in 2005 was spent on drug diversion probes, according to a 2006 IG report. Intelligence analysts, likewise spent just over five percent of their time on such investigations that same year.

The report cited a 2004 survey that found 2.4 million people “used prescription pain relievers non-medically for the first time within the past 12 months. This number was the largest number of new users for any type of illicitly used drug during that same time period.”

Additionally, the number of people who admitted to abusing prescription drugs between 1992 and 2003 nearly doubled, according to another study the IG cited.

Still, the DEA provided little instruction in the way of investigating prescription drug trafficking.

“DEA special agents have received minimal diversion control training,” the report stated. At the time of the report, only 98 special agents had taken a week-long course, while the rest had only received a two-hour session during basic training that consisted of a video from 1996.

The video was produced the same year OxyContin was made publicly available, which critics have widely blamed for initiating the opioid epidemic. The prescription painkiller’s manufacturer — Sackler Family owned Purdue Pharma — launched an aggressive and deceptive marketing campaign promoting the drug.

In fact, company representatives downplayed OxyContin’s addictiveness and consequently paid nearly $635 million in 2007 — just one year after the IG report was published — Purdue and three top executive admitted in court.

Doctors can spend years in jail if they’re caught overprescribing opioid medications, but the Purdue executives only had to pay a fine, Wolfe pointed out.

Purdue, which is now facing hundreds of lawsuits around the U.S., raked in $35 billion in OxyContin sales between the time of its release and 2015, helping The Sacklers become one of the nation’s wealthiest families with a $13 billion net worth, according to Forbes.

The Government Accountability Office (GAO), a congressional watchdog, also found problems with the diversion office — specifically regarding its ability to monitor individuals with licenses to prescribe drugs.

More than 760 people of the then-1.4 million registered with the DEA “were potentially ineligible” for licenses because the Social Security Administration reported them as dead, they did not have state-level permission to prescribe or distribute controlled substances or “were incarcerated for felony offensesrelated to controlled substances,” the 2016 GAO report stated.

Also, nearly 700 Social Security numbers in the DEA’s database were registered to multiple names or variations of names, “which can be a risk indicator of potential fraud,” the report showed.

Another nearly 42,000 entries in the DEA’s database listed an employer identification number rather than a Social Security number, the GAO found, which makes it more difficult to conduct background checks and prevent fraudulent identities.

In fact, one person convicted of defrauding Medicare in June 2013 was still actively registered with the DEA to dole out drugs as of January 2016, the GAO pointed out. The drug agency had no notes about the crime in its system.

Additionally, the DEA doesn’t conduct criminal background checks after an individual receives their license unless the crime is either self-reported or if the state of practice informs the agency, according to the GAO report.

Although the DEA’s diversion control office is supposed to be fully funded through the fees people pay to acquire the drug licenses, it’s faced periods of especially tight budgets, according to a 2008 IG report.

“I do think it is odd that the office has to be funded out of licensee fees,” Caulkins told TheDCNF. “It should be funded at whatever level it takes to get the job done. Perhaps that is less than the license fee revenue. Perhaps it is more.”

“It seems quite arbitrary to imagine that license fee revenue would end up magically providing just the right level of funding,” he continued. “But DEA would have to revoke an awful lot of licenses to seriously hurt that revenue stream (and it could presumably increase the size of the license fee by one percent to offset the losses).”

The DEA, for example, raised registration fees for the first time in 10 years in October 2003 in part to respond “to the threat of OxyContin abuse,” according to the IG report.

The DEA expected to rake in $238 million in 2006 but fell short by $75 million — or about one-third of the agency’s projection — the IG found. In 2007, the DEA settled a lawsuit that increased the amount the agency had to pay diversion investigators for overtime, which put additional financial restrictions on the diversion control office.

Consequently, the diversion office was forced to tighten its purse strings, according to the IG report.

“We found that overtime, travel and equipment purchases had been limited during the period of our review” as a result of the lawsuit and the revenue shortfalls, the report stated.

The DEA collected $235 million in fees in 2009, which increased by about 40 percent — or $93 million — by 2013, according to a 2015 GAO report. The number of registrants, meanwhile, increased by roughly 15 percent over the same period, TheDCNF’s review found.

The DEA’s role and effectiveness in fighting the opioid epidemic has also recently come under fire.

One West Virginia county with a population of less than 3,000 was flooded with nearly 21 million opioid pills from two pharmaceutical wholesalers over roughly a 10-year period, a House Committee on Energy and Commerce investigation found. Republicans and Democrats alike scrutinized the DEA for failing to stop the pill dumping.

Lawmakers have also grilled the DEA for its lack of cooperation in the committee’s investigation, and the agency has faced subpoena threats for slow-walking the release of related documents.

Additionally, pharmaceutical companies hired high-ranking DEA officials after leaving the agency, a joint Washington Post and “60 Minutes” investigation found. The agency also began to limit how often it immediately suspended pharmaceutical distributors that were shipping suspiciously large volumes of pills.

The DEA ultimately didn’t oppose a 2016 bill pharmaceutical industry-backed members of Congress sponsored and co-sponsored that essentially eliminated the agency’s ability to use such suspensions, the investigation found. The legislation consequently passed with unanimous consent, and then-President Barack Obama signed it without question.

Both Caulkins and Wolfe noted the power pharmaceutical companies hold in forming policy and legislation, which has helped bind the DEA.

“There’s enormous influence in this industry,” Wolfe told TheDCNF.

The DEA did not respond to requests for comment.

Andrew Kerr and Grace Carr contributed to this report.

Written by Ethan Barton: Follow Ethan on TwitterSend tips to ethan@dailycallernewsfoundation.org.

 

This article was republished with permission from the Daily Caller News Foundation.

Florida County Sues Companies For Aiding Opioid Crisis

(DCNF) Palm Beach County in Florida filed a lawsuit Thursday against major corporations alleging some of their business practices led to the rise of the opioid crisis.

The county in the lawsuit accuses corporations like Walmart, CVS and Walgreens for using “unfair” marketing techniques to “reverse” common understanding of opioids, which led more people to be prescribed them, reported The Palm Beach Post.

“Defendants, through a sophisticated, highly deceptive and unfair marketing campaign that began in the late 1990s, deepened around 2006, and continues to the present, set out to, and did, reverse the popular and medical understanding of opioids,” the complaint alleges. “Chronic opioid therapy—the prescribing of opioids to treat chronic pain long-term—is now commonplace.”

The opioid crisis has spiked over the past few years and Palm Beach County has been particularly affected by the crisis. A November 2017 report named the county as the “epicenter” of the crisis in the state as there were 571 heroin overdoses in the county in 2016.

“The thousands of Palm Beach County families struck by this epidemic deserve to hold someone accountable for deceptive, unscrupulous practices involving opioid dispensing, advertising and prescribing,” Palm Beach County Mayor Melissa McKinlay, a Democrat, noted in a statement about the lawsuit.

A total of 29 defendants are named in the lawsuit. One defendant released a statement pushing back against the lawsuit and its accusations.

“Given our role, the idea that distributors are responsible for the number of opioid prescriptions written defies common sense and lacks understanding of how the pharmaceutical supply chain actually works and is regulated. Those bringing lawsuits would be better served addressing the root causes, rather than trying to redirect blame through litigation,” John Parker, SVP, Healthcare Distribution Alliance, told The Daily Caller News Foundation.

Walmart, CVS and Walgreens did not return request for comment in time for publication.

 

Written by Amber Randall

 

This article was republished with permission from the Daily Caller News Foundation.

 

Legal Pot Linked to Reduced Opioid Use in Two New Scientific Studies

While many patient anecdotes have suggested that medical marijuana may be effective for chronic pain and that it could be used as an alternative to opioid pain medications, the U.S. government’s categorization of cannabis as a hardcore Schedule I narcotic with no medical use has hamstrung the ability of scientists to test that theory in clinical trials. Government-ordered studies on pot have only sought to associate it with negative externalities, and clinical trials on the safety or medical benefits of pot are effectively banned under current law.

However, pot-legal states have begun to produce volumes of data that can be analyzed by researchers, and two new scientific studies released this month in JAMA Internal Medicine have linked cannabis legalization laws with a significant reduction in opioid prescriptions filed in the state.

In the study, Association of Medical and Adult-Use Marijuana Laws With Opioid Prescribing for Medicaid Enrollees, University of Kentucky’s Hefei Wen and Emory University’s Jason Hockenberry examined “all-capture Medicaid prescription data for 2011 to 2016” between states and found that “medical marijuana laws and [recreational] adult-use marijuana laws were associated with lower opioid prescribing rates (5.88% and 6.38% lower, respectively).”

“Medical and adult-use marijuana laws have the potential to lower opioid prescribing for Medicaid enrollees, a high-risk population for chronic pain, opioid use disorder, and opioid overdose, and marijuana liberalization may serve as a component of a comprehensive package to tackle the opioid epidemic,” the study concluded.

A second study in JAMA Internal Medicine, Association Between US State Medical Cannabis Laws and Opioid Prescribing in the Medicare Part D Population by Ashley Bradford, David Bradford, and Amanda Abraham of the University of Georgia, examining “longitudinal analysis of Medicare Part D” found that “prescriptions filled for all opioids decreased by 2.11 million daily doses per year from an average of 23.08 million daily doses per year when a state instituted any medical cannabis law.”

That study also suggested that laws focused on improving medical marijuana access reduced opiate prescription rates further than other types of legalization schemes.

“The type of medical cannabis laws [MCLs] implemented in these states was important as well, with greater reductions in opioid prescriptions observed in states with more structured MCLs that increased access to medical cannabis. Prescriptions for opioids fell by 3.74 million daily doses per year (95% CI, −5.95 to −1.54) when medical cannabis dispensaries opened, but only by 1.79 million daily doses per year (95% CI, −3.36 to −0.22) when states only offered allowances for home cultivation,” read the research.

“Medical cannabis policies may be one mechanism that can encourage lower prescription opioid use and serve as a harm abatement tool in the opioid crisis,” Bradford et al concluded.

While a growing chorus of patient anecdotes have been cited by medical marijuana activists suggesting that medical cannabis has allowed them to discontinue the use of potentially-deadly opiates, the lack of scientific studies confirming this, partly due to the government’s ban on clinical research on cannabis, has often been cited by health officials in discouraging the passage of such bills.

For example, prior to the publication of these two studies, Tennessee Department of Health officials testified in a hearing on the state’s Medical Cannabis Only bill that there was not enough scientific evidence available to link medical cannabis to reduced opioid use rates or to suggest that it is effective for relief of chronic pain. On the heels of that testimony, Medical Cannabis Only died in the Tennessee Senate on Tuesday, according to The Tennessean.

Sessions Tells U.S. Prosecutors to Seek Death Penalty for Drug Dealers

Citing lesser-known statutes that have never been used before in a criminal prosecution, Attorney General Jeff Sessions issued a memo on Wednesday encouraging federal prosecutors to seek the death penalty for some drug dealers.

“Congress has passed several statutes that provide the Department [of Justice] with the ability to seek capital punishment for certain drug-related crimes. Among these are statutes that punish certain racketeering activities (18 U.S.C. § 1959); the use of a firearm resulting in death during a drug trafficking crime (18 U.S.C. § 924(j)); murder in furtherance of a continuing criminal enterprise (21 U.S.C. § 848(e)); and dealing in extremely large quantities of drugs (18 U.S.C. § 3591(b)(1)). I strongly encourage federal prosecutors to use these statutes, when appropriate, to aid in our continuing fight against drug trafficking and the destruction it causes in our nation,” read Sessions’ memo.

According to CNN, President Trump said at a Monday event in Manchester, New Hampshire, “If we don’t get tough on the drug dealers, we are wasting our time. And that toughness includes the death penalty… This is about winning a very, very tough problem and if we don’t get very tough on these dealers, it is not going to happen, folks.”

Citing that drug overdoses had caused over 64,000 deaths in 2016, Sessions’ memo added, “Drug traffickers, transnational criminal organizations, and violent street gangs all contribute substantially to this scourge. To combat this deadly epidemic, federal prosecutors must consider every lawful tool at their disposal. This includes designating an opioid coordinator in every district, fully utilizing the data analysis of the Opioid Fraud and Abuse Detection Unit, as well as using criminal and civil remedies available under federal law to hold opioid manufacturers and distributors accountable for unlawful practices.”

American Civil Liberties Union Washington Legislative Office deputy director Jesselyn McCurdy said in a statement, “Drug trafficking is not an offense for which someone can receive the death penalty. The Supreme Court has repeatedly and consistently rejected the use of the death penalty in cases where there has been no murder by the convicted individual.”

She continued, “This approach is also disturbingly reminiscent of the war on drugs, which set back American drug policy decades, and codified harm to black and brown people — laws we have just begun to reverse. And like the war on drugs — with a focus on extreme punishments instead of the root causes of drug use and no provisions to address racial disparities — the White House’s proposal will almost certainly fail to solve the actual crisis facing the country.”

In the most recent Supreme Court test of whether the death penalty can be constitutionally applied in non-homicide cases, Kennedy v. Louisiana in 2008, the court found that the death penalty could not be applied in child rape cases.

“The court concludes that there is a distinction between intentional first–degree murder, on the one hand, and non–homicide crimes against individuals, even including child rape, on the other. The latter crimes may be devastating in their harm, as here, but in terms of moral depravity and of the injury to the person and to the public, they cannot compare to murder in their severity and irrevocability,” read Justice Anthony Kennedy’s majority opinion in the case.

“Our concern here is limited to crimes against individual persons. We do not address, for example, crimes defining and punishing treason, espionage, terrorism, and drug kingpin activity, which are offenses against the State,” added Justice Kennedy in the majority opinion, suggesting that the Supreme Court has yet to test one way or the other the constitutionality of Sessions’ effort to seek the death penalty in drug trafficking cases.

https://www.youtube.com/watch?v=5_7ZeIC2Y40

Opioid Heir Ignores Addicts, Buys $23 Million Bel-Air Mansion Instead

(DCNF) An heir to a multi-billion dollar opioid fortune recently purchased a $22.5 million Bel-Air mansion, according to a recent report, but he and his family have never publicly donated to any addiction rehabilitation centers.

David Sackler is part of the family that owns Purdue Pharma, the company that manufactures OxyContin and that’s widely blamed for initiating the opioid epidemic. Purdue executives admitted to lying to doctors about OxyContin’s addictiveness and effectively reversed physicians’ fears of prescribing opioids.

OxyContin sales helped the Sacklers accumulate a $13 billion fortune, according to Forbes. None of that money has been publicly donated to rehabilitation centers, but millions have gone to art museums and other nonprofits, previous Daily Caller News Foundation investigations have found.

Meanwhile, David Sackler, who sits on Purdue’s board, spent less than two-tenths of a percent of that fortune on his new Bel-Air home. He bought the mansion in January, according to Zilliow, but TMZ first reported the news Thursday.

The four-acre, 10,000 square-foot mansion features “a huge two-story atrium with a spiral staircase that leads to a spacious master suite which encompasses almost the entire second floor, with oversized double baths, closets, decks and views galore,” Zillow’s listing shows, along with numerous photos.

Sackler’s new home, built in 1986, also has five bedrooms, eight baths, media and game rooms, and a gym.

“The grounds include a tennis court, pool, pavilion, and covered parking for eight cars,” the listing said. “Breathtaking views in all directions – very private.”

More than 200,000 Americans have died from prescription drug overdoses between 1999 and 2016, according to the Centers for Disease Control and Prevention, but that doesn’t indicate how many are still suffering from addiction. About 80 percent of heroin users began their dependence with prescription opioids, a recent study found.

Additionally, the opioid epidemic has cost the U.S. $1 trillion, according to another recent report.

Sackler is the grandson of one of Purdue’s founders and the son of one of Richard Sackler, who held numerous leadership roles – including chief executive – during OxyContin sales’ heyday. Richard owns a mansion in Austin, Texas.

The Sackler family did not immediately return a request for comment.

Written by Ethan Barton. Follow Ethan on Twitter. Send tips to ethan@dailycallernewsfoundation.org.

This article was republished with permission from the Daily Caller News Foundation.

Health and Human Services Secretary: ‘No Such Thing As Medical Marijuana’

Kettering, OH— While speaking on March 2nd at a press conference on opioids at an inpatient facility that treats newborns suffering from prenatal drug exposure, U.S. Health and Human Services Secretary Alex Azar proclaimed that “there really is no such thing as medical marijuana” in response to a question regarding what he sees as the role of medical marijuana as an alternative to opioids for pain management. Azar went on to say, “There is no FDA approved use of marijuana, a botanical plant. I just want to be very clear about that.”

Azar, who was the president of the U.S. division of Eli Lilly & Co. from 2012 to 2017, added that the government will invest hundreds of millions of taxpayer dollars into “next generation pain therapies” as an alternative to opioids.

“We are devoting hundreds and hundreds of millions of dollars of research at our National Institutes of Health as part of the historic $13 billion opioid and serious mental illness program that the President and Congress are funding,” Azar said. “Over $750 million just in 2019 alone is going to be dedicated towards the National Institutes of Health working in public-private partnership to try and develop the next generation of pain therapies that are not opioids.”

Numerous recent scientific studies in states with medicinal cannabis programs have found that marijuana has drastically reduced opioid dependence. A recent study published by the Minnesota Department of Health’s Office of Medical Cannabis revealed that among patients known to be taking opiate painkillers upon their enrollment into the program, 63 percent “were able to reduce or eliminate opioid usage after six months.”

The results from Minnesota’s program align with numerous studies conducted in other states with active medical marijuana programs. In a 2016 report, using data gathered from patients enrolled in Michigan’s medical cannabis program, indicated that marijuana treatment “was associated with a 64 percent decrease in opioid use, decreased number and side effects of medications, and an improved quality of life.”

An investigative report by Politico revealed that during Azar’s tenure at Eli Lilly, the company used erectile dysfunction drug Cialis on boys with Duchenne muscular dystrophy to increase profits from the drug and extend its exclusive patent for another six months using a process often referred to as “pediatric patent extension”. While the move reportedly profited the company a billion dollars, critics noted that it crossed ethical lines and had no effect on the children’s condition.

Sen. Rand Paul (R-KY), during Azar’s confirmation hearings in November, appears to predicted the former pharmaceutical executive’s allegiance to big pharma, stating:

I told you in my office you’ve got some convincing to make me believe that you’re going to represent the American people and not big pharma…And I know that’s insulting…because I’m sure you’re an honest and upright person…But we all have our doubts, because big pharma manipulates the system to keep prices high…We have to really fix it, and I — you need to convince those of us who are skeptical that you’ll be part of fixing it and won’t beholden to big pharma.

[WATCH: Ben Swann’s Reality Check: Jeff Sessions Wages War on Cannabis]

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Reality Check: FDA’s Disinformation Campaign on Kratom

The opioid crisis is one of the biggest stories in the U.S. with tens of thousands of Americans dying from opioid overdoses.

So why would the FDA crack down on a substance that may help save lives?

Some say the agency has actually been involved in a massive disinformation campaign against a substance called kratom. What is kratom, and why is the FDA fighting so hard against it?

This is a Reality Check you won’t get anywhere else.

Another White House administration is making fighting the opioid epidemic a top priority. And again, the focus is on the wrong thing.

What if, while ignoring the root causes of the opioid epidemic, the FDA is also fighting a substance that is saving people’s lives who suffer from opioid addiction?

Before we can answer that question, let’s talk about the substance the FDA is looking to ban. It’s called kratom.

So what is kratom?

Kratom is a tropical tree in the coffee family. It is commonly used in raw plant form, with the dried leaves used to make tea or crushed and mixed with food. Indigenous to Southeast Asia, the plant has become popular in the U.S. as a natural medicine.

So how popular is kratom?

Actually, millions of people around the world take it for chronic pain, alcohol addiction, weaning off opiates, depression, anxiety, PTSD and more.

But the FDA says kratom is actually just as dangerous as opioids. In fact, in November, the FDA Commissioner Scott Gottlieb recommended that kratom be scheduled as a Schedule 1 drug, meaning it is highly addictive and has no proven medical value.

In addition, the FDA claims that kratom is responsible for 36 deaths.

But here’s the problem: just days ago, nine leading scientists in substance addiction and safety wrote to the White House Opioid Crisis Team Leader Kellyann Conway and acting-DEA Administrator Robert Patterson.

They encouraged both to disregard the FDA’s claims about kratom, pointing out serious flaws in the agency’s claims.

“The scientists warned that ‘four surveys indicate that kratom is presently serving as a lifeline away from strong, often dangerous opioids for many of the several million Americans who use kratom. A ban on kratom that would be imposed by CSA Scheduling would put them at risk of relapse to opioid use with the potential consequence of overdose death. Similar unintended consequences are to be expected in some who would be forced to use opioids to manage acute or chronic pain.'”

These scientists went on to challenge the claims by the FDA by pointing out that, “available science is clear that kratom, although having effects on opioid receptors in the brain, is distinct from classical opioids (e.g. morphine, heroin, oxycodone, etc.) in its chemistry, biological effects, and origin.”

Kratom is not poppy based. it is a tree in the coffee family, and therefore has a reportedly milder euphoric effect than traditional opioids and opiates.

The other important rebuttal these scientists made was to point out that the FDA used significantly flawed information when it claimed kratom was responsible for 36 deaths.

“…the fatalities that the FDA lists as having been associated with kratom include deaths with a wide variety of apparent causes in people suffering from various diseases and/or taking other substances that also likely contributed to their deaths. For example, it includes 9 fatalities in Sweden that resulted from an adulterated product that included the active substance of the prescription opioid tramadol…” 

In response, the FDA commissioner released more information on those who have died, the agency says, from kratom. And that information is even more stunning.

According to HuffPo:

“Almost all of the FDA’s cases involve subjects who were found to be on multiple substances at the time of their death, with the vast majority including either illicit or prescription drugs that carry well-known fatal risks.

“FDA’s list of kratom-related deaths  includes a 43-year-old man determined to have died from complications due to deep vein thrombosis.

“He had a long list of medical problems… At the time of his death, he’d recently been prescribed five different medicines.

“His toxicology test came back positive for opioids, Xanax, antidepressants and a medication apparently used to treat his Tourette’s syndrome. He also tested positive for kratom.

“One case involves a man who had fallen out a window, broken his arm and refused treatment before dying.

“He was ultimately found to have had nine different substances in his bloodstream, among them, the primary psychoactive substance in kratom.

“One case the FDA listed as a kratom-related death, which has been completely redacted in the document, appears elsewhere in an agency database as a death by homicide due to a gunshot wound to the chest.”

So why is the FDA doing this? We don’t know the motives of the FDA but as I have shown you in the past, the FDA suffers from severe conflicts of interest, especially when it comes to the revolving door between the agency and Big Pharma.

With the government spending more than $500 billion per year to fight the opioid epidemic, one could assume there are lines of pharmaceutical companies looking for product alternatives.

But remember, any naturally occurring substance like kratom cannot be privately patented. So there is no real profit incentive for Big Pharma in kratom.

So what you need to know is that while I won’t speculate about what the FDA is ultimately trying to do, I can tell you what the FDA wants done.

The agency wants kratom to become subject to an FDA new drug application. To be clear, they say a naturally occurring plant taken in its raw form, that is helping millions of people right now, needs to be banned and become subject to a study that would take no less than 10 years and cost up to $2.5 billion dollars.

More importantly, what the FDA is recommending is exactly the opposite of the agency’s charge. There is no evidence that kratom, on its own, is harming anyone.

And so the question remains. If the FDA is successful, will the agency actually push millions of people toward more dangerous alternatives, including harmful opioids? If so, how is that making the fight against opioid abuse a priority?

That’s Reality Check. Let’s talk about that, right now, on Twitter and Facebook.

Opioid “Pill Dumping” Investigated in West Virginia

Williamson, WV — An ongoing investigation by the U.S. House Energy and Commerce Committee has revealed pharmaceutical companies flooding small towns in West Virginia with opioid pain pills between 2006 and 2016.

In fact, a pair of letters released by the committee on Tuesday revealed that between those years, drug companies shipped 20.8 million oxycodone and hydrocodone pills to two pharmacies only blocks apart in the rural town of Williamson, West Virginia, which has a population of about 3,000 according to the 2010 U.S. census.

That figure breaks down to more than 6,500 pills per resident.

“These numbers are outrageous, and we will get to the bottom of how this destruction was able to be unleashed across West Virginia,” ranking member Frank Pallone Jr. (D-N.J.) and committee Chairman Greg Walden (R-Ore.) said in a joint statement to the Charleston Gazette-Mail.

The U.S. is currently in the midst of an epidemic of opioid-related overdose deaths, which the Center for Disease Control estimates at 115 opioid related deaths daily, with West Virginia having the highest overdose death rate in the nation.

The letters released by the committee specifically addressed the distribution practices of two regional drug distributors, Ohio-based Miami-Luken and Illinois-based HD Smith, as part of an ongoing probe into “pill dumping.”

So how did the practice of mass prescribing addictive opioids begin?

One need only look to Purdue Pharma, and the Sackler family, to better understand the acceptance of these powerful painkillers for everyday medical issues.

As I previously reported for The Free Thought Project, the Sackler family, which owns 100 percent of Purdue Pharma, has amassed the 16th largest family fortune in the U.S. — estimated to be worth $14 billion dollars by Forbes in 2015 — by distributing the highly addictive, and often deadly, opiate painkiller OxyContin as a purportedly non-addictive version of oxycodone, labeling it as “abuse resistant.”

Purdue Pharma has generated estimated sales of over $35 billion dollars since releasing OxyContin in 1996. In that first year, the drug accounted for about $48 million in sales, and by 2000 that number had skyrocketed to $1.1 billion, an increase of over 2,000 percent in just four years.

By 2010, OxyContin would account for annual profits of $3.1 billion. Simply put, this family controlled almost one-third of the U.S. prescription pain business in America.

In a seemingly methodical manner, Purdue Pharma, under the guidance of brothers Arthur, Raymond, and Mortimer Sackler, began a campaign to promote their new drug, as described in The American Journal of Public Health, “The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy.”

One of the primary missions of Purdue Pharma was to identify the doctors across America prescribing the most pain medication and strategically marketed the drug directly to them as a “safe” alternative to other pain medications.

A report in The Week explains how the prevalence of opioids leading to the nationwide epidemic came to fruition:

“During its rise in popularity, there was a suspicious undercurrent to the drug’s spectrum of approved uses and Purdue Pharma’s relationship to the physicians that were suddenly privileging OxyContin over other meds to combat everything from back pain to arthritis to post-operative discomfort. It would take years to discover that there was much more to the story than the benign introduction of a new, highly effective painkiller…

“Perhaps knowing that doctors would be vigilant against prescribing drugs with the potential for abuse, Purdue set out to distinguish OxyContin from rivals as soon as it dropped. The cornerstone of its marketing campaign was the drug’s incredibly low risk of addiction, an enviable characteristic made possible by its patented time-release formula. Through an array of promotional materials, including literature, brochures, videotapes, and Web content, Purdue proudly asserted that the potential for addiction was very small, at one point stating it to be “less than 1 percent.”

The actions of Purdue Pharma, and their aggressive marketing to doctors with a proclivity to already administer pain pills loosely, are often cited as a primary driver of the deadly opioid epidemic now gripping the country. Prior to this time, doctors were reluctant to prescribe strong opioids, except for end-of-life palliative care and acute cancer pain, due the extremely addictive nature of these drugs.

Last year, there were 13 fatal drug overdoses in West Virginia’s Mingo County, of which Williamson is the county seat, and 711 deaths from drugs in the 54 other counties that make up the state, according to the West Virginia Health Statistics Center, as reported by NBC.

NBC went on to report that committee questioned the drug companies regarding whether they believed that such a large amounts of pills, going to such small towns, was appropriate or raised any “red flags”:

“In the letter to Miami-Luken, they asked whether the company made any attempt “to understand why the number of pills that it sent to Tug Valley Pharmacy increased by over 350 percent over a single year period from 2008 to 2009.”

In the letter to H.D. Smith president J. Christopher Smith, the lawmakers asked why the company supplied the two Williamson pharmacies with ‘39,000 hydrocodone pills over a two-day period in October 2007.’

‘If so, were any red flags raised about potentially suspicious orders, and were any suspicious order reports submitted to the DEA?’ they wrote.

Both companies were given until Feb. 9 to answer their questions.”

The Gazette report noted that West Virginia Attorney General Patrick Morrisey was a one-time lobbyist for a trade group that represented drug companies, including Miami-Luken.

Interestingly, several lawsuits against the company, filed by the West Virginia’s previous AG, Darrell McGraw, which charged that the drug companies had flooded the state with opioid pain pills, were settled by Morrisey in 2016.