Lawsuit by Doctors in Indiana Against DEA agents and the City

www.doctorsofcourage.org/lawsuit-by-doctors-in-indiana-against-dea-agents-and-the-city/

Four doctors in Carmel, IN, a suburb of Indianapolis, have sued the city and government officials responsible for the illegal attack on their clinic, Drug Opiate & Recovery Network (DORN), an addiction center prescribing Suboxone, in July, 2014.  The lawsuit asks for compensatory and punitive damages and requests a jury trial. Drs. Larry Ley, founder, George Agapios, Ronald Vierk, and Luella Bangura were all arrested and charged, in spite of years of continuous communication with DEA officials.  This shows the evil in the DEA.

“They destroyed the lives of 12 people that were actively trying to fight this disease, and they threw all the patients who were actively fighting addiction to the curb,” said Dr. Ley. In spite of the charges being dropped against them, or the acquittal of Dr. Ley, shedding the stigma of the raid has proved difficult for the clinic’s doctors and staff since the arrests, which is why they decided to take legal action. The employees have been unable to find other work, even though their records have been expunged.

The attorneys for the city and some of the officials have declared immunity in the lawsuit. That is the protective umbrella by which these unscrupulous DOJ officials are carrying out illegal attacks against legitimate practitioners across the country, and something we, the citizens, must remove. If a government official knowingly attacks an innocent citizen for illegal purposes, that official should be held accountable. If not, this country is moving into a police state. The plaintiffs’ claims of false imprisonment and arrest are also possibly barred due to a probable cause being filed in the case, even though that probable cause was created through perjury. Also, to show how the DOJ colludes in their illegal attacks on doctors, Assistant U.S. Attorney Josh Minkler who was first offended by the behavior of DEA agent Gary Whisenand pushing the case against Dr. Ley, is now representing Whisenand in the civil suit.

The new complaint of false arrest and violating their right to due process is against DEA agent Whisenand, the city of Carmel and Major Aaron Dietz of the Hamilton/Boone County Drug Task Force. But Dietz’s attorneys claim he was acting in good faith and is therefore immune from civil action under law. Good faith—Bull shit!! The target was picked, the case was created.

In the government’s standard propagandizing media collusion when doctors are attacked, Dietz was quoted as saying

“We make no distinction between Dr. Ley and any other drug dealer,” calling the clinic a “pill mill” and Dr. Ley “the Pablo Escobar of Suboxone.” “This type of ruse of a clinic perpetuates the problem.  Those people are still addicted to the drug and this is what’s happening.  This is not fixing the problem,” “Opiate drugs and prescription medication is a gateway to heroin.  That’s why we have heroin is because people get addicted to the opiate drug prescription medication and then go to a cheaper, readily available heroin.”

Now all of those statements are lies stated in public to defame a proper, law-abiding citizen. Shouldn’t that perpetrator of illegal activity (Dietz) have to pay for his crimes?

Dietz and Whisenand worked for months to create a case against the doctors. This is an example of tax dollars being wasted. They spent nine months watching hundreds of patients comes and go from the clinics, compiling more than 26,000 hours of video surveillance in the process. But they were unable to identify a single individual who was paying for a drug they didn’t legitimately need. So they invented some by sending undercover officers to lie about being dependent on opiates. So probable cause was a creation of the government.

Then, despite being told twice by the U.S. attorney’s office that they didn’t have a case against Ley, they arrested Ley and 11 of his employees for “providing Suboxone prescriptions to the undercover officers who had no legitimate medical need for them.”

This is a standard practice in all attacks on doctors, and primarily what they are being convicted of: “illegitimate medical practice” because the DEA agents lie to get drugs prescribed that they don’t really need. Who’s committing the crime here? But as the suspected “ringleader” of the operation Ley was booked on $1 million bond, his assets seized, and he spent a month in jail.

One by one the cases against Ley’s 11 co-defendants fell apart, as prosecutors failed to provide enough evidence that a crime had been committed. Dr. Ley was the only DORN defendant to go to trial. The charges against him applied to just 22 prescriptions for Suboxone—all written to police officers pretending to legitimately need them. That fact was not lost on Hamilton County Judge Steven R. Nation, presiding over Ley’s trial.

“I struggled with this case the minute I started to watch the surveillance videos [of the undercover agents],” Nation said, prior to announcing Ley’s acquittal. “I’ve got conditions that people were asking to be treated for [and] the drug that was issued was appropriate for what they were being asked to be treated for.”

Why aren’t more judges seeing this fact? Maybe because they ride the gravy train of convictions too?  Judges are not unbiased in these cases where money is funneled into the Department of Justice and their own courts. Ethics and morals are found less and less in the legal profession.  But at least in this case under this judge, Ley was cleared of all charges after an eight-day bench trial and all other charges against him in other counties where he ran clinics were dropped.

Jim Crum, Dr. Ley’s defense attorney stated what every defense across the country should be stating:

“Our position has been, and the judge agreed, that the judges point that if there was a violation of anything here it’s a licensing issue.” Is the doctor following the rules exactly? “Even if he wasn’t that doesn’t rise to the level of a criminal offense. There was no intent to deal, everything was in the confines of the normal practice of medicine.”

James Brainard, Mayor of Carmel

Dr. Ley was acquitted in August 2016, two years after the raid. Similar clinics across the country are being attacked and the doctors incarcerated. But here, the reason is obvious—a politically motivated effort to help developers in Carmel, directed by Mayor James Brainard. I won’t go into the possible collusion between Mayor Brainard, the Carmel Redevelopment Commission, and Pedcor here. But a detailed review of public records showed that the city had its eye on the property before Dr. Ley became a subject of a criminal investigation. In 2016, just months before the start of Ley’s trial, the city of Carmel revealed a takeover of the property across the street and construct a new mixed-use development called the “PNC Block Redevelopment” involving condominiums, commercial office space, underground parking, and an outdoor beer garden. If the goal was to force Ley out of Carmel, a conviction wasn’t necessary. DORN’s main office in Carmel never reopened, and Ley sold it for a loss to a real-estate investor.

So what is the result of attacks on legitimate clinics like this on the occurrence of addiction? Use Indiana as an example. Thanks in part to the policies of former Indiana Governor Mike Pence, treatment options in Indiana were limited even before Dr. Ley’s arrest. The state ranked 47th out of 50 states for availability of drug and alcohol treatment and Suboxone treatment was among the worst in the nation. Hamilton County ranked ninth out of 92 counties for heroin overdoses. In Indianapolis drug overdose fatalities increased seven-fold since 2000. Hamilton County alone has seen a 45 percent increase in heroin-related deaths. In 2015 more than 300 non-fatal overdoses were recorded in the four counties where Ley practiced. Two years after the closure of the DORN clinic, fatal overdoses in Indiana have risen by double digits, with only three providers certified to prescribe Suboxone in the entire city of Carmel.

This is a excellent example of the mindset of our society.. ONCE CHARGED – ALWAYS GUILTY .. REGARDLESS OF BEING INNOCENT IN THE END ! Did the City of Carmel and the bureaucrats of that city wanted to have the property that Dr Ley owned for development so that the city could generate more property tax revenue  and they would not have to go thru imminent domain and have to pay “fair value” for the property ?

It is claimed that “JUSTICE is BLIND” … but apparently for those within our justice system appear to be driven by GREED and monetary gains the judicial system can reap by “going after” certain segments of the population that has assets/resources that they can fabricate a case against and according to this article many judges and prosecuting attorneys are more than willing to be willing participants in this ruse.

At one time, Indiana was ranked NUMBER ONE in pharmacy robberies and NUMBER ONE in meth lab busts and then in 2015 had 200 people show up being HIV positive along with Hep B & C..  in small (pop 25,000) Scott County in south central Indiana.. which DNA testing showed that abt 85% was from a single source. Meaning that most of those people where involved with sharing needles.

Then Gov Pence – now VP Pence – his response to that outbreak was quite interesting ..  basically he was CLUELESS about how to proceed at first. It was like the fire dept showing up with a 5 lb fire extinguisher when your house is on fire.

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CVS Pharmacy just announced their pharmacist working hour cuts. “Verification sharing”, a technological workload share computer program, is now leading to sweeping hour cuts and overlap diminishes across our district and our neighboring district, and I’m certain the whole company chain. In my store, hours has been cut 8 full RPh hours, many others are seeing more hours cut. For a company that says they value patient safety, they are not giving us the tools we need to keep people safe. By cutting pharmacist hours, this will increase wait times and our current inabilities to get medications into the hands of our patients that need them. A deliberate move to continue lining the pockets of the top executives.

We leave 150+ undone every night, give or take…

http://www.ncpanet.org/home/find-your-local-pharmacy

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Trump’s claim of ‘amazing’ success in cutting opioid prescriptions

https://www.washingtonpost.com/politics/2019/05/02/trumps-claim-amazing-success-cutting-opioid-prescriptions

The president earns Three Pinocchios.

“One year ago, we pledged to cut nationwide opioid prescriptions by one-third. Already during my time in office, we have reduced the total amount of opioid prescribed by 34 percent. That’s a pretty amazing number.”

— President Trump, speaking at a drug abuse summit in Atlanta, April 24, 2019

During a recent speech on the administration’s efforts to ease the opioid crisis, President Trump asserted that his administration had already achieved its goal of cutting nationwide opioid prescriptions by one-third.

Trump’s original goal, made on March 19, 2018, was to reach this target within three years. So obviously we were curious about whether the claim about already reaching the milestone within a year was valid.

Here’s what we found out. It’s an interesting tale of how data generated in the administration loses its nuance the closer it gets to the president’s lips.

The Facts

The president, after noting the goal to cut prescriptions by one-third, framed this achievement in personal terms: “Already during my time in office, we have reduced the total amount of opioid prescribed by 34 percent.”

But a White House fact sheet, issued the same day, pitched this less as an administration achievement and mentioned no goal, though it kept the time period: “In the first two years of the Administration, we saw a 34 percent decrease in the total amount of opioids prescribed.”

Finally, the agency that generated the statistic, the Department of Health and Human Services, was even more careful in its own fact sheet. It cast the percentage decline as tentative and requiring additional research: “From the President’s inauguration in January 2017 through February 2019, initial market data suggests that the total amount of opioids being prescribed monthly has dropped by 34 percent. While we need more data to confirm this snapshot, it shows we may have succeeded in meeting this [three-year] goal already.”

As you can see, it is a bit like a game of telephone, with the accuracy of the statement getting diminished with each retelling. Our eyebrows went up when we saw that the statistic apparently was based on monthly data points.

An HHS spokeswoman provided the numbers. The data reflected the nationwide prescribing of opioids measured in MMEs (morphine milligram equivalents — a measure of opioid amount/intensity), drawn from the IQVIA National Prescription Audit, a database for retail pharmacy and mail pharmacy channels only.

January 2017: 13,627,002,271

February 2019: 8,967,556,436

(Technical note: These numbers are not comparable to prescription data on the Centers for Disease Control and Prevention’s website because it does not include controlled long-term care environments — nursing homes and skilled-nursing facilities — or prescriptions for buprenorphine, which is primarily used for patients in treatment.)

That’s certainly a decline of 34 percent. Experts said that using an MME measure is probably the most useful (though a prescribing rate rather than raw numbers might be more informative).

But there are several problems.

First, two monthly data points are not especially useful to measure long-term progress. We were able to review all of the monthly data, though not publish it. February in recent years for some reason appears to experience big drops, and that happens to be the end point. A three-month rolling average shows a decline, though not as stark as 34 percent.

“Measuring the decrease using monthly prescriptions is absolutely legitimate,” said an HHS spokesman. “We focus on leading indicators to help us better and more quickly respond to this crisis, rather than waiting a year to evaluate what we are doing.”

But, more important, time did not start with the Trump administration. Opioid prescriptions have been declining for years, having reached a peak in 2010 or 2012, depending on what data set you use. The declines especially began to accelerate after the CDC in March 2016 issued new guidelines for prescribing opioids for chronic pain — 10 months before Trump took the oath of office.

HHS has published quarterly fiscal-year data for MMEs dispensed since the second quarter of fiscal year 2013. It shows that decline really sped up in early 2016, about the time the CDC guidelines were issued. The number of MMEs dispensed has fallen about 30 percent from the second quarter of the 2016 fiscal year (January-March) to the end of 2018.

Just looking at second quarter of fiscal year 2017 through the end of fiscal year 2018 — essentially Trump’s first two years — the decline amounts to 22 percent, from 41 billion MMEs a quarter to 32 billion MMEs.

Finally, we would argue that the president’s pledge was to reduce opioids by one-third in three years dating from his speech in March 2018, because he said: “We’re going to cut nationwide opioid prescriptions by one-third over the next three years.” We reviewed administration briefings after the speech and news coverage and can find no indication it was anything other than a three-year goal starting in 2018. Reporters identified 2021 as the end date.

That would mean at least a reduction of 12 billion MMEs — from 35 billion MMEs a quarter at the time of the speech to 23 billion. Backdating to the start of Trump’s presidency seems to be moving the goal posts, as the decline in MMEs on a monthly scale since Trump’s speech is about 20 percent, not 34 percent.

Asked whether progress should be measured from March 2018, the HHS spokeswoman replied: “While the March 2018 date marks the release of ‘President Donald J. Trump’s Initiative to Stop Opioid Abuse and Reduce Drug Supply and Demand,’ efforts to combat the opioid crisis were already well underway. The opioid epidemic has been a top priority for the Trump Administration since taking office in January 2017.”

Experts in the field said the decline in prescriptions is less impressive than it sounds because the trend significantly predates the Trump administration — and because the more important metric is reducing overdoses.

“By itself, the number of prescriptions is not a public-health outcome,” said Joshua Sharfstein, vice dean for public health practice and community engagement at the Bloomberg School of Public Health at Johns Hopkins University. “You can’t say mission accomplished because the number of prescriptions has gone down.”

Sharfstein noted that even as prescriptions have begun to shrink in recent years, overdoses have soared. (Recent 12-month rolling provisional CDC data touted by the administration indicates the overdose increase may have plateaued and even begun to decline.) The reasons for this disconnect are the subject of dispute among medical professionals, with some arguing that cutting back on opioid prescriptions may have led some people to switch to heroin or synthetic opioids. Other experts say the data does not support that analysis.

In any case, they said, Trump is wrong to suggest this is an administration success story, even if it has taken steps such as pushing for a reduction in opioid manufacturing.

“I don’t think the Trump administration deserves credit for the more cautious prescribing of opioids,” said Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University. “The reduction in prescriptions began in 2012 and improved a bit in 2016. Everything we are seeing is trending in the right direction, but no other country prescribes as much as we do.”

The Pinocchio Test

There are several problems with the way the president framed this statistic. He should have indicated the data was tentative, as HHS responsibly did, but instead he suggests a goal has already been achieved. (As we noted, the goal posts also appear to have been moved.) Moreover, he once again takes credit for a trend that started in the Obama administration, in part because of actions taken under that administration.

The president earns Three Pinocchios.

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I-Team: Feds back-pedal on opioid crackdown

https://www.lasvegasnow.com/news/local-news/i-team-feds-back-pedal-on-opioid-crackdown/1971009919

LAS VEGAS (KLAS) — Millions of Americans suffering with chronic pain are hoping for relief, now that the CDC has clarified its guidelines led to a nationwide crackdown on prescription opioids.

The overwhelming majority of opioid related overdoses are caused by illicit drugs, including heroin, not prescription medication, but Nevada and other states have imposed restrictions on legal pain management. Now, state lawmakers are working on changes in the law that will allow doctors to do their job and ease the suffering of legitimate pain patients.

“There are tens of thousands of patients that have been involuntarily tapered down or off their opioids and they’re suffering. They’re in pain,” said Rick Martin, retired pharmacist.

Retired pharmacist and patient advocate Rick Martin relates to the tens of millions of Americans coping with chronic pain since he is one himself. When the CDC issued its supposedly voluntary guidelines in 2016, it never meant for states to enact them into law, or for insurers and pharmacy chains to impose even harsher limits on pain medication, but that’s exactly what happened.

Now, three years later, CDC has admitted its guidelines have been misapplied in Nevada and elsewhere. The FDA and surgeon general have also weighed in, confirming what the I-Team has been reporting for years — that millions of Americans suffering with legitimate intractable pain have had their lives destroyed, and in some cases, ended.

In particular, Martin cites military veterans, many of them injured in combat, now cut off from pain relief by the Veterans Administration. Martin thinks it is no coincidence that 20 veterans commit suicide every day.

“They go back, some of them, as far as the Vietnam War, veterans who’ve been under medication for years and years, 20 years without any problems and they’re all of a sudden taken off. These are our veterans. They fought for our country. They deserve to have pain relief,” he said.

Nevada joined the anti-opioid bandwagon by enacting a law which placed excessive requirements on doctors, not as strict as in other states, but enough to cause some doctors to quit prescribing opioids altogether or to leave medicine.

“There are hundreds of patients who are not able to get into a pain doctor. We have a waiting list that’s a year long. We had a guy on the phone the other night crying because he can’t get into a pain doctor and he’s tried everywhere,” said Dr. Dan Laird. I felt terrible but there’s nothing I can do. The hysteria that’s been whipped up about opioids and continues to be used as a talking point among politicians continues to hurt patients.”

Dr. Laird is encouraged by recent statements by the CDC and the FDA urging physicians and states to back away from forced tapering of pain medication, but he worries changes will come too late for many patients who are in pain now. Public policy consultant Terry Murphy thinks Nevada lawmakers have received the message.

“In Nevada, there’s a real recognition there needs to be safeguards but physician discretion must be balanced with that,” said Terry Murphy, Strategic Solutions.

She is tracking two bills in the legislature which would strengthen a doctor’s ability to prescribe pain medication. Murphy says that is a call to be made by physicians, not the government.

“No person responds to a disease the same as the next guy on the bench and no person responds to a medication the same as the next guy. that’s where all the education and experience of your doctor comes in,” Murphy said.

Dr. Laird and other advocates urge pain patients to contact their legislators and let them know how they feel. One bill, AB 239, has already been approved by the Nevada State Assembly and Wednesday had its first hearing in the Senate.

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https://www.facebook.com/pharmaciststeve

if you are using Firefox… it doesn’t like some other browser or go to my facebook page

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My pain med refills were supposed to be picked up yesterday. Got a call from my PM doctor this morning saying I need to fill them at another pharmacy. Dropped them off on Monday, pharmacy manager said I can pick them up the 1st. So, called the Walmart where I’ve been getting ALL my prescriptions filled for for the past 6 yrs; same prescriptions every month. Although they did force me to stop taking my meds for severe insomnia; I was told to choose which medication and condition was more important. Sleeping 2 hrs a day, sometimes up for more than 36 hrs w/o sleep is incredibly bad for your health and overall well being (not that they give a shit)…but was forced to choose. I had hour long discussions 6 yrs ago with the pharmacy manager about why I needed them; was post-op from a 9 hr spine surgery, my 4th, had to show medical records to prove my conditions etc. I’ve been given pages and pages of docs over those 6 yrs, telling me about the dangers of opioids, the limits, etc., listened to degrading lectures and the manager telling me my son will find me dead on the floor etc.(I’m on VERY low doses compared to others), and suddenly, the other pharmacist decided after 6 yrs, he’s not going to fill my Opioid prescriptions anymore. He told me I have to have the pharmacy manager fill them bc he refuses to. The pharmacy manager is the one I dropped them off with and he said I could pick up on the 1st. So, suddenly after 6 years, only he can fill them bc the other refuses, for no reason at all. Never filled early, only use the one Walmart, same Dr, same prescriptions for 6 yrs, suddenly he refuses to fill them. Problem is the manager only works every other weekend. So, if I need to fill them and he’s off or pn vacation, I’ll have to wait days or weeks until he returns. If he gets transferred or quits, I’m screwed. This freaking pharmacist, after 6 yrs of no issues, has been suddenly delaying almost every one of my prescriptions for weeks, even for the hydroxyzine that I take for itching, for no reason at all, so I now often go without. Even Lunesta, he said I should only take as needed, and I said no, my doctor said 1 per day for a reason. He didn’t care, I was forced to go out of town for 2 weeks w/o my sleeping pills, which is extremely bad for my health as I said, I can go days without sleep. So, having showed the mgr ALL my medical records 6 yrs ago, explaining all my conditions, having many discussions, having a friendly relationship for 6 yrs, and carefully following the “rules” to avoid any issue that would raise red flags or denials, I thought I would be safe from denials and refusals to fill medically necessary Opioid medications. I was wrong, doesn’t matter what you do, you can follow all the rules, shown them medical records proving why they’re needed, never fill early, never take more than needed, stick with one doctor, one pharmacy, on and on, it DOESN’T MATTER ONE BIT!! A pharmacist can take away your treatment any time they feel like it, after 1 yr or 20 yrs, even if you follow everything “rule” to the letter, it doesn’t matter. ONE pharmacist controls your entire life, every aspect of it, and there’s not a damned thing you can do about it. They decide if you get out of bed, play with your kids, suffer excruciating pain…ONE human being who isn’t even medically trained, should NEVER have that kind of power..EVER!!! I’m absolutely fuming and pissed off. It’s out of control when legit patients are forced to suffer because of 1 person w/o the knowledge or training to know if it’s medically necessary or not! If a Democrat wins in 2020 and we’re forced onto govt, single payer healthcare with no choice, I can guarantee all pain relief will be banned and taken away from every single American. Screw those legit, responsible, law abiding ppl suffering, all they care about is the drug addicts who abuse legal drugs so they can take them away from all of us. Don’t see them cracking down on illegal drugs do you? They’re perfectly fine and doing zero with the tons of illegal drugs coming over the border. I for one am f’ing sick of this shit!!

This is from a Wal Mart Pharmacist in central FL..  At the end of 2015 the Florida Board of Pharmacy implemented new regulations that every Pharmacist was to have 2 hr of continued education every 2 yrs and that Pharmacist were not suppose to start looking for a reason to NOT FILL A PRESCRIPTION… I was at the board meeting in mid-June of 2015 and I heard the then “head” executive director ? – paid staff member… state that they were going to “teach Pharmacists COMMON SENSE”..  To the best of knowledge the FL Board of Pharmacy has never taken any action against a Pharmacist for refusing to fill a controlled substance with the reason “just because I can”…  Maybe they are not violating that regulation because they don’t even start looking for a reason to refuse to fill a controlled substance… the standard reason is the same for all pts ?

It was reported last year that Wal Mart was implementing a new “abuse score” on pts using Narxcare provided by the company https://apprisshealth.com/solutions/narxcare/.  Maybe this artificial algorithm has given this pt a HIGH SCORE and company policy mandates that they have to refuse to fill some of her controlled substances to get her “score down”..who knows…

It only appears from this message that the pt is suffering and the pharmacist is “gloating” that he “cut off another potential substance abuser”

http://www.ncpanet.org/home/find-your-local-pharmacy

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Find your local independent pharmacy – typically won’t screw with pt’s medically necessary meds

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Another front in war on opioids: Criminal charges for Big Pharma execs, MDs

https://www.jdsupra.com/legalnews/another-front-in-war-on-opioids-66941/

An estimated 400,000 Americans have died due to opioid drug overdoses between 1999 and 2017 — and the fatalities only are increasing. By 2025, according to expert forecasts, there will be 700,000 more opioid deaths. Prosecutors now are saying  that at least some of the causes of this crisis are nothing less than criminal behavior by people wearing white coats and ties.

Federal and state prosecutors are bringing felony charges against doctors and Big Pharma executives as if they were street drug dealers and crime bosses.

This formal faulting for the nation’s opioid crisis hasn’t yet spread widely among drug makers, those at the pinnacle of the pharma pipeline. The legal war, however, has resulted in aggressive steps by federal prosecutors accusing not only scores of doctors across seven states with improperly prescribing painkillers for cash and sex, but also with officials filing for the first time drug-trafficking charges against a major pharmaceutical distributor and two of its former executives.

The criminal cases will combine with an avalanche of civil lawsuits to break down the wall of denial that key players — Big Pharma, doctors, nurses, insurers, and others — have tried to construct about their roles in creating the nation’s opioid and overdose crisis, which has become a leading killer of Americans younger than 55.

In the U.S. criminal justice system, of course, the accused are entitled to a presumption of innocence. But the scope and scale of the wrongs that prosecutors blame on drug case defendants may make it difficult for them to assert their ignorance about widespread, destructive, debilitating, and addictive products and practices they promoted.

Executives at the Rochester Drug Cooperative — one of the nation’s leading pharma distributors — for example, ignored “red flags and shipped tens of millions of oxycodone pills and fentanyl products to pharmacies they knew were distributing drugs illegally,” the New York Times reported, adding of the firm, its ”sales soared, as did the compensation of the chief executive.”

The newspaper elaborated:

[RDC execs] Laurence F. Doud III and William Pietruszewski, were also charged with conspiring to distribute drugs and defrauding the government … Mr. Pietruszewski, 53, of Oak Ridge, N.J., who was the chief compliance officer, was also charged with failing to file reports to the authorities about suspicious orders for controlled substances. He pleaded guilty last week and is cooperating with prosecutors … Mr. Doud, 75, the former chief executive officer, pleaded not guilty … and was released on a $500,000 bond. If convicted, Mr. Doud faces a mandatory 10-year minimum sentence and a maximum of life in prison. The charging documents portray a company largely animated by Mr. Doud’s greed. As chief executive, he drove up the sales of oxycodone pills up nine-fold over four years, from 4.7 million in 2012 to 42.2 million in 2016. Fentanyl sales shot up even more over the same period, to 1.3 million doses from 63,000 doses, the documents said. And Mr. Doud’s compensation, tied to the sales, more than doubled, climbing to over $1.5 million.

Doud has proclaimed his innocence, claiming that colleagues at the No. 6 drug distributing firm in the country are trying to make him the scapegoat for shameful practices that RDC has acknowledged in a separate, civil consent decree with federal officials. The New York Times says the company “admitted in court papers that it intentionally violated federal narcotics laws by shipping dangerous, highly addictive opioids to pharmacies, knowing that the prescription medicines were being sold and used illicitly.” RDC will pay a $20 million fine, agree to abide by drug laws now, and submit to independent monitoring for five years.

The Washington Post reported that the criminal prosecution of RDC may provide a template for officials to pursue actions against major firms like McKesson, Cardinal Health and AmerisourceBergen. The three control 90% of drugs in this country, taking them from makers and shipping them to pharmacies nationwide. The companies have rare insight into the process, including what individual pharmacies order, where their customers come from, and how they pay. Federal law requires them to flag suspicious transactions, including surges in orders, out-of-proportion volumes, and big cash payments.

All three firms, the Washington Post reported, have settled civil cases with the federal government for failing to crackdown on opioid sales, including instances where small drug stores were inundated with painkilling pills far in excess of common-sense sales.

Some in the federal Drug Enforcement Administration earlier wanted criminal charges brought against the distributors. But a Washington Post-60 Minutes investigation found that the corporations waged a legal battle to prevent stiffer actions, including criminal charges or the yanking of the firms’ required drug licenses. Big Pharma also hired away key government agency staff in moves that undercut attempts at tougher opioid oversight.

For now, though, Uncle Sam is talking tough, with Geoffrey S. Berman, the U.S. Attorney for the Southern District of New York, saying in statement:

This prosecution is the first of its kind:  executives of a pharmaceutical distributor and the distributor itself have been charged with drug trafficking, trafficking the same drugs that are fueling the opioid epidemic that is ravaging this country.  Our Office will do everything in its power to combat this epidemic, from street-level dealers to the executives who illegally distribute drugs from their boardrooms.

Similar tough talk came from officials in a federal task force that took aim at “corrupt medical professionals” who inundated the nation’s Appalachian region with painkiller prescriptions and made the area one of the worst ravaged by the opioid crisis, the New York Times reported. The newspaper described some of the physicians’ tawdry behavior, thusly:

Some doctors performed unneeded medical procedures to justify the pills they prescribed, prosecutors said, while others simply passed out prescriptions without going to the trouble of disguising their purpose. One of the doctors facing charges in Ohio had at one time prescribed more controlled substances than anyone else in the state, prosecutors said. A pharmacy in Dayton, Ohio, was accused of dispensing more than 1.75 million pills. And a nurse practitioner in Tennessee who called himself the Rock Doc was accused of prescribing hundreds of thousands of pills in exchange for sex.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be wreaked on them by dangerous drugs, notably opioids. It took time and bad actions by an array of parties — Big Pharma, doctors, nurses, hospitals, insurers, and others — to create this drug epidemic, which will take considerable, sustained effort to reverse.

It may seem extreme to some to charge executives for crimes associated with their corporate activities. Not so. The public won’t be fooled, as a new survey found, with respondents saying Big Pharma must be held accountable for the opioid crisis. As prosecutors told Washington Post reporter Lenny Bernstein about their new charges with Big Pharma execs, “guys in expensive suits don’t do well in jail.” That message, they hope, will ring alarm bells, not only for drug distributors but also those who are directors and C-suite execs for drug makers, too. Jurors are deliberating still a complex criminal case against John Kapoor, the founder of Insys pharmaceuticals and aggressive promoter of the fentanyl product Subsys. The wealthy and philanthropic Sacklers have found themselves under such fire for harms tied to the painkiller OxyContin from their family firm Purdue that they now want a “global resolution” of more than 2,000 civil suits in which their entangled.

It may be satisfying to see those who can be proven to have harmed others brought to justice, whether street drug dealers or boardroom bad actors. That’s only a part of what needs to occur. President Trump and his administration can’t jaw away this nightmare and they can’t rely on excellent prosecutors alone to deal with the opioid crisis. The nation needs, too, a comprehensive plan to assist the millions who have been hooked on and debilitated by opioids and the illicit drugs for which the painkillers have served as a gateway. Opponents need to think hard about their resistance to opioid treatment that, yes, may require patients to receive other drugs, including widespread availability of the antidote naloxone. And individuals with chronic, proven pain should get thoughtful, considered medical services — not just an abrupt shutoff of medications that may help them when administered appropriately. We’ve got a lot of work to do.

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Another Lawmaker Overlooks Pain Management in Bill to Fight Opioid Crisis

www.rewire.news/article/2019/03/28/another-lawmaker-overlooks-pain-management-in-bill-to-fight-opioid-crisis/

Hardly a day goes by when the discussion of opioids and their misuse is not on the front page of local or national newspapers. However, the flipside of the issue, pain management, is barely, if ever, centered in the conversation.

This came up most recently with Republican Sen. Rob Portman of Ohio, who seeks to advance a bill he previously introduced called the Comprehensive Addiction and Recovery Act 2.0, which would, among other things, establish a three-day limit for opioid prescriptions.

This lack of focus on disabled and chronically ill patients has inadvertently pitted doctors against their own patients, who are framed as going down the rabbit hole of dependency following a sprained ankle or routine dental surgery. But this overly simplistic framing erases people with long-term disabilities and chronic health conditions who are struggling to live their lives while being punished for using the best tools we have available to enable their full participation in society.

The Centers for Disease Control and Prevention (CDC) in 2016 offered strategies to taper patients off opioids, but left doctors and patients with their decision-making authority, as it should. However, while the CDC clearly intended the guidelines to be just that—recommendations—that’s not how they’ve been interpreted.

As of last fall, 33 states have put policies in place that limit a person’s access to pain medication, in some cases to three to seven days of medication with no available refills. In some states, this means that patients are forced to go back to the doctor, enduring the burdens of medically unnecessary appointments just to get a new prescription, in order to get the medication they need every seven days.

These are people for whom opioids allow them to go to school, work a job, and manage their home life. In the words of Maelee Johnson, a disability advocate, in an interview for this piece: “Dependence isn’t addiction, and that is continually left out of the discussion and the policies being made.”

This costs lives, Johnson added. “Since the opioid crisis became a political issue, I’ve lost access to all my medication, and I dread having to convince doctors that I need these meds to survive again. The consequences of this are very far reaching.”

It’s not a legislator’s job to diagnose a patient’s ailment or prescribe relief. That responsibility falls to clinicians, who go to school for years for this specialty. And yet, time after time, lawmakers in Congress think they are equipped to address the complex needs of millions of individual patients with their policymaking. In the case of Sen. Portman’s bill, this is especially concerning in light of data pointing to the disastrous impact of arbitrary day-centered limits on pain treatment.

While this bill and similar efforts—including one by Democratic Sen. Kirsten Gillibrand of New York, whose recent policy announcement ended in her pledging to work more closely with the disability and chronic health communities to fix her bill—have an exemption for “people with chronic pain,” this approach fails to take into account what that will mean in practice for actual patients.

Research shows that even when there are exemptions, the patients’ needs are overridden as physicians fear being punished for over-prescribing medication. “Despite exemptions for [chronic pain] patients in the CDC Guideline and Tennessee state law, [a nurse practitioner at Vanderbilt University’s hematology department] had seen a major push from state regulators and insurers to get [sickle cell disease] patients down to lower doses,” noted a 2018 report from Human Rights Watch.

The report showed that legislative interventions such as these do have an impact on the quality of care doctors can provide to their patients who live with chronic pain. Doctors are interpreting the CDC guidelines and congressional action as broad, iron-clad requirements, and patients and people with chronic illnesses are the ones struggling.

Every person experiences pain differently, and legislation addressing this issue needs to take that into account.

Evidence shows that policies inserting the government into the doctor-patient relationship don’t work. For one thing, the majority of people with addiction issues tied to opioids do not receive them from a medical professional. Rather, they receive them from a friend, colleague, or they purchase them on the black market, according to data from the Substance Abuse and Mental Health Services Administration. Furthermore, the U.S. Department of Veterans Affairs, when working on limiting access to opioids among its community, issued a report in 2018 that clearly showed how restrictions did not result in fewer veterans overdosing. It resulted in more veterans dying by suicide, according to the research.

If you enact a policy and it results in constituents dying, it’s a bad policy.

This is what happens time and time again when policymakers craft legislation based on “good intentions” versus tapping into the deep expertise and “lived experience” of the disability community.

Inconsistent enforcement by the Drug Enforcement Administration has also led physicians to be concerned about the prescriptions they’re writing for patients. But it isn’t just the DEA pressuring and arresting physicians; when government intervention is not successful, insurance companies may meddle in complex patient care decisions. The America’s Health Insurance Plans (AHIP) has announced it will begin to track how physicians are complying with these new policies. Though this surveillance data will not be released to the public initially, there is little doubt it will be used to track the preponderance of opioid prescriptions.

This will compound the pressure already on doctors to not diagnose people with chronic pain and will lead to a decrease in access to pain management.

Additionally, there is a concern we will see an expanded list of drugs under restriction; we have already seen anti-seizure and anti-anxiety drugs like gabapentin included in recent state regulations. Broadening what drugs are included will undoubtedly expand who is affected. As we saw when allergy medications became restricted due to their use in manufacturing crystal meth, many times a medication that could be used to combat one symptom could be used for a nefarious purpose.

Instead of trying to force a flawed, one-size-fits-all policy onto hundreds of millions of people in the United States, legislators in Congress should support the dissemination of unbiased, science-based information about appropriate opioid use. Part of the current challenge is that so much of that information is produced by the pharmaceutical industry.

The marketing of OxyContin by Purdue Pharma is a great example of how this can be a conflict of interest. Purdue flew doctors on all-expenses-paid trips to resorts around the country to “educate” them about the merits of the drug. At the same time, the Food and Drug Administration was concluding that OxyContin was not any more effective than any other drug on the market. In 2007, the manufacturer pled guilty to misrepresenting how addictive the drug was and received a significant fine.

Rather than letting pharmaceutical companies run roughshod over clinicians, doctors need education about impacts of over-prescribing, and continuing medical education (CME) requirements should focus on responsible and careful pain management and the consequences of over-prescribing opioids.

Arbitrary limits on the days of medicine a person can receive is not good policy. Nor does it help people. And isn’t that gist of the Hippocratic oath?

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Bedford Police Department. The Bedford Police Department works day in and day out to keep our Bedford community safe. To address the drug epidemic that neighborhoods across Indiana continue to face, officers are working with our local schools to teach all students to have drug-free futures. I’m honored to fight for our law enforcement officers and first responders in Congress to keep them safe.

Trey Hollingsworth  Indiana 9th District House Member

Various entities have been trying to “teach all students to have a drug-free future” for over FOUR DECADES.  That is TWO GENERATIONS that we have tried to “educate on not smart to abuse drugs”.  So since we have as many or more people abusing controlled substance now as back them… Is this a FAILURE of all those various entities who have tried to reach kids ?

OR Is this a issue that our country has a substantial and/or growing number of people who are dealing with mental health issues for various reasons ?

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