Tag Archives: big pharma

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.

FDA Committee Recommends Approval of Pharmaceutical CBD

Washington, D.C. — An advisory committee for the Food and Drug Administration (FDA) on Thursday recommended approval of the first pharmaceutical grade cannabidiol (CBD) medicine to treat severe epilepsy. In a unanimous decision, the committee voted to recommend GW Pharmaceuticals drug Epidiolex for approval.

Cannabidiol, commonly referred to as CBD, is a non-psychoactive cannabis derivative. The approval of Epidiolex would be limited to treating seizures in patients aged 2 and older caused by Lennox-Gastaut syndrome and Dravet syndrome.

“Epidiolex represents hope for the many individuals living with intractable seizures and rare epilepsies, who every day face incredible challenges and disabling seizures, and live with the continual risk of serious injury and death,” said Philip Gattone, president and CEO of the Epilepsy Foundation.

[Related: In CBD-Legal Tennessee, Cops Raid Shops Selling Non-THC CBD Gummies]

Taking a natural product such as CBD oil and turning it into a FDA approved drug has the potential to limit the avenues that people have to access the natural product. Motherboard reported last year on the drug industry lobbying for legislation that would outlaw CBD oil by turning it into a drug. South Dakota Senate Bill 95 had sought to exempt CBD from the definition of cannabis, thus taking it off Schedule I controlled substance list and becoming a Schedule IV substance.

GW Pharmaceuticals and its U.S. subsidiary, Greenwich BioSciences, lobbied for an amendment to the legislation to limit CBD rescheduling to only FDA-approved products— in other words, they wanted only CBD drugs to be legally obtainable.

A 2017 report from Motherboard explained:

Not surprisingly, GW Pharmaceuticals has just such a drug in the pipeline. Epidiolex, a ‘proprietary oral solution of pure plant-derived cannabidiol,’ has already been given to epileptic children in the U.S. as part of a federal investigative study documented recently in the New England Journal of Medicine.”

“Since no other pharmaceutical company has a CBD drug anywhere close to market, and the wide range of CBD products already available in medical marijuana states lack FDA approval, if the bill had passed with that amendment intact, patients in South Dakota would have been subjected to a virtual CBD monopoly …

More ominously, The Great CBD Battle of South Dakota appears to be but the opening salvo in a nationwide war between GW Pharmaceuticals and traditional medical cannabis providers …

[U]nder the amendment, South Dakota would … ban myriad CBD products already available in many other states. Even though they cost far less than Epidiolex, and are potentially more effective for patients, since in addition to CBD those ‘full spectrum’ cannabis extracts also contain small amounts of THC and other medicinal components of the plant.

Motherboard also noted that “corporate lobbyists in more than 20 states are currently pushing to make sure the pharmaceutical industry has the only legal supply of CBD.” Thus, it appears the big pharma takeover of CBD is underway.

“It’s incredibly important as a physician prescribing to patients that we know what we’re giving them and we know we give them one month will be the same that we give them three or six months later,” said Dr. Orrin Devinsky, director of NYU Langone Epilepsy Center, attempting to explain the importance of pharmaceutical intervention in the CBD market.

“It’s very important to highlight that the drug used in this study, cannabidiol, was derived from cannabis plants, and purified to 99 percent purity,” Devinsky told NBC News. “This is not something you can get from a dispensary today in the United States. It’s not something that you can get by smoking marijuana. It is a very specific pharmaceutical grade product derived from marijuana, but quite different than what is available anywhere else right now in the United States.”

NBC News reported that the FDA has indicated that it will likely approve Epidiolex. Although the recommended use for this particular product is very limited, doctors may prescribe it at their discretion.

“Both by Lennox-Gastaut syndrome and Dravet syndrome are rare, severe, refractory epilepsy syndromes with onset in early childhood,” the FDA stated.

“The results from these three studies provide substantial evidence of the effectiveness of CBD for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome (LGS and DS),” the FDA said in briefing documents given to the advisory committee ahead of Thursday’s meeting.

“In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are serious, debilitating, and life-threatening disorders.”

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]

New Truth In Media Episodes: Confronting Big Pharma’s Manipulation, Influence

Many Americans have become increasingly aware that U.S. government agencies often fall short in providing transparency to its citizens, leading to failure in fulfilling their mission to adhere to policies for the protection of the American people.

Over the last few years, Truth In Media has discussed multiple instances in which agencies including the IRS, DEA, FBI, NSA, VA and others have been placed under public scrutiny in recent years for numerous cases of questionable conduct.

Many of these agencies, funded by taxpayer dollars, frequently claim to serve as a crucial safeguard, yet far too often they have been found to be serving outside interests at the expense of citizens.

When it comes to providing transparency and following proper procedure in protecting the health of the American people, where does the FDA stand? Has this agency maintained its integrity in maintaining oversight of drug companies? Is this agency doing its job to the best of its ability in assuring that our medicines have been rigorously tested, and is it making sure that drugs found to be dangerous are assigned proper warnings or removed from the market?

Truth In Media will be asking these questions in a brand new series: Truth In Media: Big Pharma, The FDA & Health Propaganda, seeking to provide a more thorough look into the relationships between FDA employees and the pharmaceutical industry, as well as the ways in which big pharma holds an enormous amount of influence over not only the FDA, but also physicians, medical journals, politicians, drug research, and ultimately millions of Americans.

This 4-segment series begins with Part 1 premiering in the first week of June. Stay tuned!

Nevada GOP Legislator Calls for Study on Links Between Pharmaceuticals, Mass Killers

Following recent media reports of high-profile mass shootings, a Republican assemblywoman from Nevada is calling for an investigation into whether pharmaceutical psychiatric medications commonly taken by mass murderers can cause side effects that may contribute to their mental health decline.

According to KSNV Las Vegas, GOP Assemblywoman Michele Fiore says that, rather than blaming mass shootings on the guns used by the perpetrators, studies should be done on the drugs that many of them have a history of having taken to treat mental health disorders.

We have to look into what is being prescribed and what is in these meds just like clinical studies. Why don’t we do studies on the medication all of these shooters were taking and take that medication off the market? Obviously, medications can alter your mind just as alcohol can alter the mind,” said Fiore.

[RELATED: Unarmed Army Vet Chris Mintz Shot Multiple Times After Confronting Ore. Shooter]

Though it is not yet known whether the perpetrator in last week’s tragic shooting at Umpqua Community College in Roseburg, Ore. was on psychiatric medication, early reports from The Oregonian note that he identified himself by the social media screen name “lithium love,” he mentioned anger and depression in a note that was found in connection with the attack, and he had a long history of behavioral problems in school. He had also been discharged by the U.S. Army midway through basic training in 2008 and graduated from a school that The Oregonian described as “geared for special education students with a range of issues from learning disabilities, health problems and autism or Asperger’s Disorder.

In August of this year, a CBS46 Atlanta Reality Check report by Ben Swann raised questions about the possibility of a connection between mass murderers and pharmaceutical drugs used to treat mental health disorders, noting that 26 high-profile perpetrators had been taking psychiatric medication. Watch it in the below-embedded video.


Should Children Be Compliant Drones or Free Thinkers? Why ADHD Diagnoses Are on the Rise in U.S. Schools

Opinion by Joshua Cook | Jan. 25, 2015


“Medicate your son, or find another school.”

I was shocked and confused when I heard those words from the Christian school my son attends, a place where he is thriving academically.

I felt angry that they were giving up on him so quickly, and then a bit disappointed in my 5-year-old for misbehaving in the classroom.

As someone who has been diagnosed with ADHD, I know what it’s like to be constantly bored in the traditional classroom.  And I also know first hand of the horrible side effects of ADHD medication.  I know that’s he’s no angel, but I also know what he’s going through. Like me, he is a free thinker who wants to share his imaginative ideas and gets frustrated with rules and the structure of traditional education. Traditional education that manufactures compliant drones instead of free thinkers like him.

In American schools, “those divergent,” those who don’t fit into the U.S. system, are often medicated into submission.

So is the problem with American children or the American educational system? Apparently children in France don’t have ADHD problems like we do in the U.S.

According to Psychology Today, Marilyn Wedge, Ph.D., wrote that at least 9 percent of school-age American children are diagnosed and medicated for ADHD. In France, that number is less than .5 percent. What makes France different from the United States in regards to the diagnosis and treatment of ADHD?

The main difference is how each country treats ADHD. In America, psychologists consider it to be a biological disorder with biological causes. Because of this, the preferred treatment is biological, in the form of medications like Concerta, Ritalin and Adderall.

That point of view is not shared by French child psychologists, who treat ADHD behavior “as a medical condition that has psycho-social and situational causes.”

According to Wedge, that means that children in France aren’t medicated. “French doctors prefer to look for the underlying issue that is causing the child distress—not in the child’s brain but in the child’s social context. They then choose to treat the underlying social context problem with psychotherapy or family counseling,” she wrote.

“This is a very different way of seeing things from the American tendency to attribute all symptoms to a biological dysfunction such as a chemical imbalance in the child’s brain,” she added.

How did we get to the place in our culture where we look to Big Pharma to solve life’s worst problems? But for the French, these problems are not universal problems. They are merely American problems…

So I’m not moving to France to solve this problem. There is a free market and I can find other options to help my son.

I believe Ron Paul has created a great case why parents should consider home schooling as a viable option to educate their children. It’s an option that’s becoming more and more attractive to me.

What’s your thoughts? Please comment below.