DEA Agents Sold Opioids, Stole Cash, and Falsely Identified Drug Suspects, Say Feds

Seize the drugs. Sell the drugs. Arrest the buyers. Repeat.

www.reason.com/2017/10/04/dea-agents-sold-opioids-stole-cash/

Four former Drug Enforcement Administration (DEA) operatives face federal corruption and conspiracy charges after allegedly engaging in all sorts of shady behavior, from selling drugs themselves to lying under oath, falsifying records, falsely identifying drug suspects, accepting bribes, and stealing cash and other property from the people they arrested. In at least one instance, their behavior led to someone being wrongly imprisoned for more than two years.

The dirty drug warriors—special agent Chad Scott, with the DEA since 1997, and former task force officers Rodney Gemar, Karl Newman, and Johnny Domingue—worked with the DEA’s New Orelans Division. Gemar and Newman also work for local law enforcement agencies.

In an indictment unsealed this week, Scott, Newman, and Gemar—a Hammond Police Department officer since 2004 and DEA Task Force Officer since 2009—are accused of seizing money and other property from those they arrested and then keeping it for themselves. (Notably, the feds do not frame this as theft from the suspects but as embezzling funds from the DEA.) This went on for at least seven years.

Scott is also accused of accepting $10,000 from a defendent in a federal criminal case in exchange for recommending that prosecutors seek a reduced sentence and, in another case, tampering with witness testimony.

Scott allegedly coerced Frederick Brown (a defendent in his own drug case) “to falsely testify that Jorge Perralta was present during drug transactions between Edwin Martinez and [Brown], when in fact Frederick Brown had never seen Jorge Perralta during his drug transactions with Edwin Martinez.” Scott reportedly offered his own false testimony in the case as well.

The DEA agent claimed that it was Brown who initially brought up Perralta when talking about people who were around during deals and might be Martinez’s supplier, referring to Perralta not by name but as “the little Mexican guy.” Scott said that he showed Brown a photograph of Perralta on his phone, and that Brown confirmed this was the dude he had seen during drug deals.

An arrest warrant was issued, and Scott went to Houston to help police there arrest Perralta for conspiracy to distribute heroin and cocaine. Perralta’s phone was seized, he was taken into custody, and—without even being allowed to contact his parents or girlfriend—he was whisked away to Louisiana. That was in March 2015.

After nearly two and a half years behnd bars, Perralta was released in August 2017 and all charges against him were dismissed.

Brown had never brought up Perralta on his own, say prosecutors in their indictment against Scott. And when shown a picture of Perralta, Brown said that he had never seen him.

Both Scott and Gemar were arrested on October 1 and released on bond the next day.

Newman and Domingue were arrested in 2016. According to federal prosecutors, Newman seized and sold thousands of dollars worth of cocaine and oxycodone. Some of these drugs he seized from a woman identified as R.G. “by means of actual and threatened force, violence, and fear of injury…to R.G.’s person and the persons of her family.”

Domingue is accused only of falsifying records related to this illegal drug seizure. His trial is set February 2018.

Newman has agreed to plead guilty to one count of “conspiracy to convert property” and one count of using a gun in furtherance of a crime of violence, in exchange for prosecutors dropping the other charges against him. He faces fines of up to $500,000 and possible life in prison, with a mandatory minimum sentence of at least five years.

 

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Internal drug company emails show indifference to opioid epidemic

https://www.washingtonpost.com/investigations/internal-drug-company-emails-show-indifference-to-opioid-epidemic-ship-ship-ship/2019/07/19/003d58f6-a993-11e9-a3a6-ab670962db05_story.html

In May 2008, as the opioid epidemic was raging in America, a representative of the nation’s largest manufacturer of opioid pain pills sent an email to a client at a wholesale drug distributor in Ohio.

Victor Borelli, a national account manager for Mallinckrodt, told Steve Cochrane, the vice president of sales for KeySource Medical, to check his inventories and “[i]f you are low, order more. If you are okay, order a little more, Capesce?”

Then Borelli joked, “destroy this email. . .Is that really possible? Oh Well. . .”

Previously, Borelli used the phrase “ship, ship, ship” to describe his job.

Those email excerpts are quoted in a 144-page plaintiffs’ filing along with thousands of pages of documents unsealed by a judge’s order Friday in a landmark case in Cleveland against many of the largest companies in the drug industry. A Drug Enforcement Administration database released earlier in the week revealed that the companies had inundated the nation with 76 billion oxycodone and hydrocodone pills from 2006 through 2012. Nearly 2,000 cities, counties and towns are alleging that the companies knowingly flooded their communities with opioids, fueling an epidemic that has killed more than 200,000 since 1996.

The filing by plaintiffs depict some drug company employees as driven by profits and undeterred by the knowledge that their products were wreaking havoc across the country. The defendants’ response to the motion is due July 31.

In January 2009, Borelli told Cochrane in another email that 1,200 bottles of oxycodone 30 mg tablets had been shipped.

“Keep ’em comin’!” Cochrane responded. “Flyin’ out of there. It’s like people are addicted to these things or something. Oh, wait, people are. . .”

Borelli responded: “Just like Doritos keep eating. We’ll make more.”

Borelli and Cochrane did not return calls for comment Friday night.

In a statement Friday night, a spokesman for Mallinckrodt sought to distance the company from Borelli’s email: “This is an outrageously callous email from an individual who has not been employed by the company for many years. It is antithetical to everything that Mallinckrodt stands for and has done to combat opioid abuse and misuse.”

The Controlled Substances Act requires drug companies to control against diversion, and to design and operate systems to identify “suspicious orders,” defined as “orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.” The companies are supposed to report such orders to the DEA and refrain from shipping them unless they can determine the drugs are unlikely to be diverted to the black market. The plaintiffs, in the filing, allege that the companies ignored red flags and failed at every level.

[76 billion opioid pills: An epidemic unmasked]

At Cardinal Health, one of the nation’s largest drug distributors, then-CEO Kerry Clark in January 2008 wrote in an email to Cardinal senior officials that the company’s “results-oriented culture” was perhaps “leading to ill-advised or shortsighted decisions,” the filing contends.

In the previous 18 months, Cardinal had been hit with nearly $1 billion in “fines, settlements, and lost business as a result of multiple regulatory actions,” the filing alleges, including the suspension of licenses at some of its distribution centers for failing to maintain effective controls against opioid diversion.

Cardinal Health did not immediately return a request for comment Friday night.

On Aug. 31, 2011, McKesson Corp.’s then-director of regulatory affairs, David B. Gustin, told his colleagues he was concerned about the “number of accounts we have that have large gaps between the amount of Oxy or Hydro they are allowed to buy (their threshold) and the amount they really need,” according to the filing, which cites Gustin’s statements. “This increases the ‘opportunity’ for diversion by exposing more product for introduction into the pipeline than may be being used for legitimate purposes.”

According to the filing, he had earlier noted to his colleagues that they “need to get out visiting more customers and away from our laptops or the company is going to end up paying the price . . . big time.”

Another McKesson regulatory affairs director responded: “I am overwhelmed. I feel that I am going down a river without a paddle and fighting the rapids. Sooner or later, hopefully later I feel we will be burned by a customer that did not get enough due diligence,” according to the filing.

McKesson is the largest drug distributor in the United States. It distributed 14.1 billion oxycodone and hydrocodone pills from 2006 to 2012, about 18 percent of the market, according to the DEA database.

The Post had made public a significant portion of a government database that records the flood of prescription opioid pain pills distributed across the U.S. View Graphic

The Post had made public a significant portion of a government database that records the flood of prescription opioid pain pills distributed across the U.S.

McKesson said that the DEA was responsible for setting the annual production quota of pills.

“For decades, McKesson has consistently reported opioid transactions to the DEA,” McKesson spokeswoman Kristin Chasen said in a statement. “We have also invested heavily in further strengthening our anti-diversion program.”

Until Friday, the documents had been sealed under a protective order issued by U.S. District Judge Dan Polster. The order was lifted a year after The Washington Post and HD Media, which publishes the Charleston Gazette-Mail in West Virginia, filed a lawsuit for access to the documents and a DEA database tracking opioid sales, known as the Automation of Reports and Consolidated Orders System, or ARCOS.

The drug companies and the DEA strenuously opposed the release of the data and the documents, and Polster agreed with them. But a three-judge panel of the U.S. Court of Appeals for the 6th Circuit in Ohio ordered that some of the information should be released with reasonable redactions and the database should be made public.

By consolidating cases from around the nation, the Cleveland case, for the first time, provides specific information about how and in what quantity the drugs flowed around the country, from manufacturers and distributors to pharmacies. The case also brings to light internal documents and deliberations by the companies as they sought to promote their products and contend with enforcement efforts by the DEA.

The local and state government plaintiffs in the case argue that the actions of some of America’s biggest and best-known companies — including Mallinckrodt, Cardinal Health, McKesson, Walgreens, CVS, Walmart and Purdue Pharma — amounted to a civil racketeering enterprise that had a devastating effect on the plaintiffs’ communities.

[How have opioids affected your community? Share your story.]

The case is a civil action under the Racketeer Influenced and Corrupt Organizations (RICO) Act, making use of a law originally developed to attack organized crime.

In statements to The Post on Tuesday in response to the release of the DEA database, the drug companies issued broad defenses of their actions during the opioid epidemic. They have said previously that they were trying to sell legal painkillers to legitimate pain patients who had prescriptions. They have blamed the epidemic on overprescribing by physicians and also on corrupt doctors and pharmacists who worked in “pill mills” that handed out drugs with few questions asked. The companies also said they should not be held responsible for the actions of people who abused the drugs.

The companies said that they were diligent about reporting their sales to the DEA and that the agency should have worked with them to do more to fight the epidemic, a point former DEA agents dispute. The companies also note that the DEA set the quotas for opioid production.

“We report those suspicious orders to state boards of pharmacy and to the DEA but we do not know what those government entities do with those reports, if anything,” Cardinal Health said in a statement.

The companies issued statements rejecting the plaintiffs’ allegations.

McKesson said in its statement: “The allegations made by the plaintiffs are just that — allegations. They are unproven, untrue and greatly oversimplify the evolution of this health crisis as well as the roles and responsibilities of the many players in the pharmaceutical supply chain.”

Mallinckrodt said the company “has for years been at the forefront of preventing prescription drug diversion and abuse, and has invested millions of dollars in a multipronged program to address opioid abuse.”

Drug Enforcement Administration agents raid a pain management clinic in Delray Beach, Fla., in February 2011. A DEA database released this week revealed that drug companies had inundated the nation with 76 billion oxycodone and hydrocodone pills from 2006 through 2012. (Carline Jean/South Florida Sun-Sentinel/AP)

‘Kingpin within the drug cartel’

One of the biggest points of contention in the lawsuit is whether the nation’s largest drug companies did enough to identify suspicious orders of opioids. What exactly constitutes a suspicious order is at the heart of the case.

The DEA has long said there should be no confusion because the agency has given frequent guidance and briefings to the industry, and repeatedly defined what constitutes a suspicious order.

The plaintiffs argue that the companies failed to “design serious suspicious order monitoring systems that would identify suspicious orders to the DEA” and shipped the drugs anyway.

[As lawyers zero in on drug companies, a reckoning may be coming]

“Their failure to identify suspicious orders was their business model: they turned a blind eye and called themselves mere ‘deliverymen’ with no responsibility for what they delivered or to whom,” according to the plaintiffs’ filing.

Between 1996 and 2018, the plaintiffs alleged in the filing, drug companies shipped hundreds of millions of opioid pills into Summit and Cuyahoga counties in Ohio, filling orders that were suspicious and “should never have been shipped.”

“They made no effort actually to identify suspicious orders, failed to flag orders that, under any reasonable algorithm, represented between one-quarter and 90 percent of their business, and kept the flow of drugs coming into Summit and Cuyahoga Counties,” the plaintiffs’ lawyers wrote.

In 2007, the DEA told Mallinckrodt that the numeric formula it used to monitor suspicious orders was insufficient, the filing contended. It alleges the company’s suspicious order monitoring program from 2008 through 2009 consisted of solely verifying that the customer had a valid DEA registration and that the order was accurately logged into the DEA’s tracking database.

From 2003 to 2011, Mallinckrodt shipped a total of 53 million orders, flagged 37,817 as suspicious but stopped only 33 orders, the plaintiffs’ filing states.

A Mallinckrodt employee said in a deposition that the DEA had described the company as the “kingpin within the drug cartel” in a meeting with the agency in July 2010, according to a footnote in the filing.

In 2011, the filing cites a Justice Department document in which the DEA alleged that Mallinckrodt “sold excessive amounts of the most highly abused forms of oxycodone, 30 mg and 15 mg tablets, placing them into a stream of commerce that would result in diversion.”

According to the DEA, the filing states, “even though Mallinckrodt knew of the pattern of excessive sales of its oxycodone feeding massive diversion, it continued to incentivize and supply these suspicious sales,” and never notified the DEA of the suspicious orders.

In a settlement with the DEA, Mallinckrodt agreed that from Jan. 1, 2008, through Jan. 1, 2012, “certain aspects of Mallinckrodt’s system to monitor and detect suspicious orders did not meet the standards” outlined in letters from the DEA deputy administrator for diversion control.

Mallinckrodt was the nation’s leading manufacturer of oxycodone and hydrocodone, with 28.8 billion pills from 2006 to 2012, 37.7 percent of the market, according to the DEA database. It has since created a subsidiary for its generic opioids called SpecGx.

The Post reported in 2017 that federal prosecutors said 500 million of the company’s 30 mg oxycodone pills wound up in Florida between 2008 and 2012 — 66 percent of all oxycodone sold in the state. Pills at that dosage are among the most widely abused.

Prosecutors said the company failed to report suspicious orders, and Mallinckrodt that year settled the case by paying a $35 million fine.

“Mallinckrodt’s actions and omissions formed a link in the chain of supply that resulted in millions of oxycodone pills being sold on the street,” then-Attorney General Jeff Sessions said at the time.

McKesson Corp., the nation’s largest opioid distributor, doled out 14.1 billion oxycodone and hydrocodone pills from 2006 to 2012, about 18 percent of the market, according to the newly released DEA database. (Kris Tripplaar/Sipa USA)

‘Business as usual’

The same year that Mallinckrodt paid its fine, McKesson, the nation’s largest drug distributor, was fined a record $150 million by the Justice Department.

According to allegations in the new court filing, McKesson frequently increased the amount of opioid pills it sent to its pharmacy customers.

“McKesson has a long history of absolute deference to retail national account customers when it comes to [opioid] threshold increases,” the plaintiffs argue in their filing, citing a deposition of McKesson’s senior director of distribution operations.

McKesson had set limits on the amount of opioids its customers could order, the filing contends, but those limits were often lifted.

“In August 2014, DOJ noted that McKesson appeared to be willing to approve threshold increases for opioids for the flimsiest of reasons,” the filing contends.

For shipments to pharmacies in Summit and Cuyahoga counties, McKesson did not report a single suspicious order between May 2008 and July 2013, the filing says. During that time, McKesson filled 366,000 opioid orders in those two counties.

McKesson reached its settlement with the government in January 2017 for allegations of failing to report suspicious orders. It was the second time the company was fined over suspicious orders. Nine years earlier, it paid $13 million.

The government said in 2017 that McKesson “failed to design and implement an effective system to detect and report ‘suspicious orders.’ ” The company shipped more than 1.6 million orders of opioid pills between 2008 and 2013 but reported just 16 as suspicious, according to the Justice Department.

However, “before the ink of the settlement agreement was even dry,” the new filing argues , McKesson was already reassuring customers who were concerned that the flow of opioids would be curtailed that it would remain “business as usual” at the company. McKesson sent more than 68 million doses of oxycodone and hydrocodone to those counties between 2006 and 2012, according to DEA tracking data analyzed by The Post.

Gustin, McKesson’s former director of regulatory affairs, was recently indicted in federal court in Kentucky on a charge of illegally distributing opioids. His attorney wrote in a court filing that the allegations against his client stem from his job at McKesson and “seem to focus on the manner by which he performed his former position as Director of Regulatory Affairs.”

Gustin’s lawyer and the prosecutor in the case did not return calls for comment.

The southwest Virginia city of Norton, with a population of about 4,000, saw millions of prescription opioids arrive in seven years, with the city’s CVS pharmacy receiving 1.3 million opioids from 2006 through 2012, according to the DEA database. (Charles Mostoller for The Washington Post)

Pickers and packers

The plaintiffs in the Cleveland case alleged that CVS, the nation’s largest pharmacy chain, did not implement required controls to identify suspicious orders from 2006 until early to mid-2009.

The CVS compliance coordinator said that her title “was only for reference and not her real job position and that the only thing she ever did related to suspicious order monitoring was to update the [Standard Operating Procedures Manual],” the plaintiffs allege.

A system that CVS used to monitor suspicious orders was known as “Pickers and Packers,” according to the filing.

The pickers and packers were workers in the distribution centers who would pick and pack opioid orders. A CVS official testified that the company did not have any written policies, guidance or training programs to teach the pickers and packers how to detect suspicious orders, according to the filing.

“Instead, the Pickers and Packers would identify orders based on a gut feeling or a crude rule of thumb that essentially can be summarized that they believed the order was simply too large,” the filing states. “One of the Pickers and Packers . . . testified that she was trained by another Picker and Packer in 1996 and that as a rule a Picker and Packer should not send out more than 12 of the small bottles, six of the larger bottles and two or three of the largest bottles. She used this rule of thumb for her entire career.”

CVS’s system flagged few orders, the filing contends : A CVS distribution center in Indianapolis flagged two orders per year from 2006 through 2014.

CVS rejected the plaintiffs’ arguments.

“As part of our response in this case, we will be presenting the expert opinion of a former high-ranking DEA official who concluded independently that our systems were compliant and that the plaintiffs’ analysis is unfounded,” CVS spokesman Mike DeAngelis said.

‘Obvious signs of diversion’

Walgreens used a formula to identify thousands of pharmacy orders as suspicious but shipped them anyway, the filing alleges. The orders were reported to the DEA after they had been shipped, according to agency documents quoted in the filing.

“Suspicious orders are to be reported as discovered, not in a collection of monthly completed transactions,” the DEA wrote in an immediate suspension order issued against Walgreens in 2012. “Notwithstanding the ample guidance available, Walgreens has failed to maintain an adequate suspicious order reporting system and as a result, has ignored readily identifiable orders and ordering patterns that, based on the information available throughout the Walgreens Corporation, should have been obvious signs of diversion.”

In one case, Walgreens’s suspicious order report to the DEA was 1,712 pages long and contained six months’ worth of orders, including reports on 836 pharmacies in more than a dozen states and Puerto Rico, the filing alleges.

The filing also alleges that Walgreens stores could “place ad hoc ‘PDQ’ (“pretty darn quick”) orders to controlled substances outside of their normal order days and outside of the [suspicious order monitoring] analysis and limits.”

The Post has previously reported that Kristine Atwell, who managed distribution of controlled substances for the company’s warehouse in Jupiter, Fla., sent an email on Jan. 10, 2011, to corporate headquarters urging that some of the stores be required to justify their large quantity of orders.

“I ran a query to see how many bottles we have sent to store #3836 and we have shipped them 3271 bottles between 12/1/10 and 1/10/11,” Atwell wrote. “I don’t know how they can even house this many bottle[s] to be honest. How do we go about checking the validity of these orders?”

A bottle sent by a wholesaler generally contains 100 pills.

Walgreens never checked, the DEA said. Between April 2010 and February 2012, the Jupiter distribution center sent 13.7 million oxycodone doses to six Florida stores, records show, many times the norm, the DEA said.

Walgreens ranked second among distributors in the nation, with 13 billion pills and 16.5 percent of the market for oxycodone and hydrocodone from 2006 through 2012, the DEA database shows. It stopped distributing opioids to its stores in 2014, but continues to dispense controlled substances.

As part of a settlement with the DEA in June 2013, Walgreens said that its “suspicious order reporting for distribution to certain pharmacies did not meet the standards identified by DEA.” The company paid an $80 million fine to the government.

In a statement to The Post earlier in the week, Walgreens defended its operations, saying, “Walgreens has been an industry leader in combating this crisis in the communities where our pharmacists live and work.”

Aaron C. Davis, Jenn Abelson, Amy Brittain, Robert O’Harrow Jr., Shawn Boburg, Jennifer Jenkins, Andrew Ba Tran, Aaron Williams and Katie Zezima contributed to this report.

Since 1996, the two drugs: Nicotine & Alcohol have killed abt 12 million people – SIXTY TIMES OPIATES

 

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I Will Not Be Shamed for Using Opioids to Manage My Cancer Pain

https://www.healthywomen.org/content/article/i-will-not-be-shamed-using-opioids-manage-my-cancer-pain

by April Doyle

The pain starts in my sit bones, radiates into my pelvic area and moves up and down my spine. When I’m having a good day, my pain is a 5 or 6 out of 10 on the pain scale. Some days, my pain escalates to an 8 or 9 and I can’t function. But when I take my opioids, the pain decreases. I can move again. I can breathe again. I can handle my full-time job. I can go to the park with my 8 year old son. I can manage my pain.

So when I went to the pharmacist in my hometown in California and the pharmacist again refused to fill my opioid prescription, I was frustrated and angry. Not only did he say that he couldn’t fill my prescription, but he made me feel like I was doing something wrong by trying to get my pain pills. I was made to feel less than human.

In order to stay alive, in order to function, I need to take 20 pills a day, four of which are opioids. It’s my only option. I have stage 4 metastatic breast cancer that is in my spine, my hips and my lungs. I don’t even take as much as is prescribed to me. But when you have metastatic cancer in your bones, the pain is so severe that you can’t even function. If you need breast augmentation surgeon then check out the post right here.

It all started in 2009 at the age of 31 when I found a lump in my breast. Everyone kept saying to me, “I’m sure it’s fine.” But I instinctually knew something wasn’t right. After nothing showed up on the mammogram, I decided to go in for a lumpectomy and have it biopsied. All the doctors were surprised when it came back as breast cancer, stage 1B. I had a bilateral mastectomy with reconstruction, 4 months of chemotherapy and then I was declared cancer free!

Fast forward 5 years: I had some back pain, which I thought was sciatica. I wasn’t too concerned because otherwise, I felt great. I went into my oncologist for my 5-year check-up and he said, “Congrats! You are doing great!” But two days later, the nurse from the cancer center called and left me a voicemail saying, “Oops. We spoke too soon.” I was now told I was stage 4 and the cancer had metastasized to my bones and lungs. I had terminal cancer.

Pain management is now a major facet of my cancer treatment. I have had steady treatment for the past 5 years and am now on my 5th line of treatment. I have exhausted all my anti-hormonal treatments and am currently getting chemotherapy intravenously. I’ve also had two different rounds of radiation to help with the pain. Along with antidepressants, anti-nausea drugs, nerve blockers, supplements, and over-the-counter pain relief pills, I now take an opioid thanks to my home care that offers cancer care services with the best caregivers that manage my health.

My oncologist prescribes the opioid and the insurance company covers it without any issue. But I’ve had numerous negative experiences with this particular pharmacist. They have told me they don’t have enough pills and they’ve told me to come back another day.

When my anger and frustration took over, I posted a video explaining what had happened. I had no idea that the video would strike such a nerve with a bigger population. But it did. Thousands of people reached out to me to share their experiences having trouble getting their prescriptions filled for much needed pain medications.

Watch the video here.

The anti-opioid movement has created difficulty for those of us who need opioids for pain relief. This is a problem that affects all sorts of people with many different chronic diseases. Although the pharmacy issued an apology to me, I have decided to go to a different pharmacy in my hometown and no longer give the other one my business. People with chronic pain want to be able to function, to sleep, to work, and to be able to have quality time with their families without hurting all the time. We have valid reasons for needing opioids and our stories need to be heard.

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Does the drop in US drug deaths mean the opioid crisis is ending?

https://www.newscientist.com/article/2210550-does-the-drop-in-us-drug-deaths-mean-the-opioid-crisis-is-ending/

For the first time since 1990, the number of annual drug overdose deaths in the US has declined. The 5 per cent fall reported by the Centers for Disease Control and Prevention (CDC) is almost entirely due to a drop in deaths from prescription opioid painkillers. Does this mean the opioid crisis has peaked?

The early data predicts that there were 68,500 drug overdose deaths in the US in 2018, down from 72,000 the previous year. “The preliminary CDC data showing a drop in overdose deaths is certainly encouraging, but it is too early to determine whether this represents a true shift in overdose trends,” says Tisamarie Sherry, at the policy think tank Rand Corporation in California.

But it is unknown whether overdose deaths will continue to fall, says Sherry.

“The CDC data shows that overdose deaths from fentanyl, synthetic opioids, cocaine and methamphetamines are still increasing, which is an ominous sign.”

Drug overdose deaths in the US related to prescription opioids rose from just over 3,400 in 1999 to about 17,000 in 2017. This dramatic upwards trend reflects a nation-wide epidemic of opioid use and abuse. Recent data from the US Drug Enforcement Agency revealed that between 2006 and 2012, 76 billion oxycodone and hydrocodone pain pills – two common prescription opioids – were distributed in the US. That’s about 460 pills per person.

Reversing overdoses

The epidemic has hit US states differently, and these new numbers bear that out. Deaths continued to rise in some eastern states where the use of illicit fentanyl, a highly potent synthetic opioid, is spreading. But deaths are dropping in some midwestern states where local governments have expanded treatments for addiction and monitoring of prescriptions.

Even with this recent reduction in overdoses, the death toll from drugs in the US is still high, with tens of thousands of people overdosing on opioids each year. The recent decrease may be due to increased availability of naloxone – which blocks the effects of opioids and is used by emergency medical practitioners to reverse an overdose – and better training to use it.

If emergency treatment, rather than reduced drug use, is largely behind the fall, this would mean an increasing number of US adults are living with substance abuse disorders. Prescribing restrictions mean many of these are likely being pushed towards using street drugs.

Unintended consequences

“Some well-intentioned policies may have unintended consequences,” says Sherry. “For example, our recent research on prescription opioid use found that while the rate of new opioid prescriptions has fallen in recent years – which we generally believe is a good thing – a large number of physicians have stopped initiating opioids altogether,” she says.

While that may sound like a good thing,  “it’s not clear whether that degree of opioid hesitancy does more good or harm to patients with severe pain.”

This isn’t the first time the rate of opioid deaths has slowed for a year. They appeared to stall in 2011 and 2012, but the death rate then shot back up as fentanyl made its way into the US. Fentanyl deaths in 2018 continued to rise, but grew at a slower rate than the past several years. So, it’s fair to be only cautiously optimistic when it comes to a possible break in the wave of opioid-related deaths.

These new numbers are still being finalised, and may increase when the final CDC report is published later this year. They also do not include deaths related to infection from intravenous drug use.

Furthermore, renewed attempts to overturn President Obama’s Affordable Care Act are currently underway. Should these succeed, many people who currently receive legal pain relief may end up turning to illegal drugs if they lose their health insurance. Celebrating the end of the opioid epidemic would be extremely premature.

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$57.1 Million Lyme Disease Lawsuit Filed Against CDC

“Unprecedented” lawsuit claims CDC wrongfully terminated agreement to evaluate guaranteed “no false-positive” DNA based Lyme test utilizing superior technology.

Washington, D.C. – Dr. Sin Hang Lee, pathologist, founder and owner of Milford Molecular Diagnostics, a CLIA-certified diagnostic laboratory in Milford, Conn. (www.dnalymetest.com), today filed a lawsuit with the U.S. Court of Federal Claims alleging that employees of the Centers of Disease Control and Prevention (CDC) unilaterally terminated a contractual agreement under which the CDC agreed to evaluate a “no false-positive” DNA based Lyme disease test, a currently available test that vastly improves the speed and accuracy of Lyme disease diagnosis for sufferers, and one that is capable of diagnosing all tick-borne borrelial infections.

“Dr. Lee notified the CDC of his intention to bring suit on July 19, 2017. This first step was a procedural requirement to exhaust administrative remedies before any citizen can file such lawsuits against the CDC due to its sovereign immunity protection,” said Attorney Mary Alice Moore Leonhardt, of Moore Leonhardt and Associates, a Hartford, Conn., based law firm, who filed the suit on Dr. Lee’s behalf. “The waiting period has passed without any attempted administrative remedies and Dr. Lee’s lawsuit, unprecedented in its scope, is allowed to go forward.”

According to Dr. Lee, his test is based on Sanger DNA sequencing capability, a far superior medical technology than the twenty-five year old two-tiered serology test which remains the standard test typically administered by health care professionals to identify Lyme disease in patients. American and international scientific and medical communities have, for years, acknowledged a high rate of false results emanating from the serology tests.

“While serology tests represented excellent technology for Lyme a generation ago,” said Dr. Lee, “medical scientific technology has advanced greatly since then. For patients’ sake, the CDC and standard medical care needs to catch up. This test offers Lyme disease sufferers a great leap forward.”

In the lawsuit, Dr. Lee claims that he has a contractual agreement through two Material Transfer Agreements signed in 2013 by Dr. Elizabeth Bell, the then director of National Center for Emerging and Zoonotic Infectious Diseases [NCEZID], a division of CDC and subsequent correspondences with two CDC officers to launch a national project to validate a reliable routine 16S rRNA DNA sequencing-based method for the diagnosis of Lyme and other tick borne borreliosis at the early stage of infection before antibody levels are measurable.

Dr. Lee also claims the CDC is fully aware that Dr. Lee’s DNA sequencing test is based on textbook molecular biology principles and may become the gold standard for diagnosing not only Lyme disease, but all tick-borne borrelial infections.

Instead of implementing Dr. Lee’s science-based direct DNA test for improving patient care, the CDC has chosen to use its regulatory power to block widespread application of this highly reliable direct DNA test and channel public funds to promote CDC’s own patented, but immature indirect metabolomics technology for Lyme disease diagnosis, a technology known to be prone to false positives.

The need for such direct molecular detection method in the United States was stated by Dr. Martin Schriefer of NCEZID at an open HHS conference on September 24, 2012 as directed by the U.S. House of Representative’s Appropriations Committee bill of September 2009 and further reinforced by a recent House Report 115-244 to accompany H.R.3358 for FY 2018 https://www.congress.gov/congressional-report/115th-congress/house-report/244/1 in which the Committee on Appropriations specifically “encourages CDC to expand activities related to developing sensitive and more accurate diagnostic tools and tests for Lyme disease…”.

However, after Dr. Lee informed the CDC that he was going to publish his findings that some of the CDC reference serum samples for Lyme disease serology tests in fact contained residues of Borrelia miyamotoi and a novel unnamed relapsing fever borrelial strain, instead of the commonly expected Borrelia burgdorferi species, indicating a diversity of causative agents which are causing clinical Lyme disease in the United States, the CDC suddenly stopped communicating with Dr. Lee and his associate without warning or explanation.

Additionally, in a letter dated February 26, 2016 which has been circulating in the social media, Dr. Bell accused Dr. Lee of having published “inconsistent results.” Dr. Bell has refused to point out the inconsistent results in Dr. Lee’s report, which has been published in a peer-reviewed journal. Dr. Lee claims that the mischaracterization of Dr. Lee’s scientific publication by Dr. Bell as a regulatory officer constitutes an act of defamation with the purpose to cause harm.
Dr. Lee seeks damages of no less than 10 percent of the CDC-estimated Lyme test market values in seven large U.S. commercial laboratories in 2008, i.e., 10 percent of $492 million, as adjusted for inflation using the Consumer Price Index: $57.1 million.

Dr. Lee said he intends to use the money to help hospitals located in Lyme endemic areas to set up DNA testing laboratories to diagnose Lyme and other tick-borne borrelial infections for timely treatment. Dr. Lee also said his DNA sequencing test for Lyme borrelia diagnosis is now pending New York State Department of Health’s final approval to be used for New York State residents.

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Washington Post Revelation of Pain Pill Distribution Only Helps to Fuel the False Narrative

https://www.cato.org/blog/washington-post-revelation-pain-pill-distribution-only-helps-fuel-false-narrative

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Medical culture encourages doctors to avoid admitting mistakes

www.statnews.com/2017/01/13/medical-errors-doctors/

If you become the victim of a medical error, should you trust your doctor to be forthright about his or her role in the mistake? That could be a bad idea. An alarming new study says that most doctors would try to obscure their role in the mistake, and most wouldn’t even apologize.

The study, conducted by a national team of researchers, posed two hypothetical scenarios involving medical error to more than 300 primary care physicians and asked how they would react. The first scenario involved a delayed diagnosis of breast cancer; the second involved a delayed response to a patient’s symptoms due to a breakdown in the coordination of the patient’s care. Most (more than 70 percent) of the physicians surveyed said they would provide “only a limited or no apology, limited or no explanation, and limited or no information about the cause.” The report was published last fall in the journal BMJ Quality and Safety.

The researchers noted that the strongest predictors of disclosure were “perceived personal responsibility, perceived seriousness of the event and perceived value of patient-centered communication.” In other words, doctors decide whether a mistake is a big enough deal to reveal to their injured patients.

In reality, the factor that most influences doctors to hide or disclose medical errors should be clear to anyone who has spent much time in the profession: The culture of medicine frowns on admitting mistakes, usually on the pretense of fear of malpractice lawsuits.

But what’s really at risk are doctors’ egos and the preservation of a system that lets physicians avoid accountability by ignoring problems or shifting blame to “the system” or any culprit other than themselves.

The lengths to which some doctors will go to shirk their responsibility to be upfront about medical errors are astounding. I consulted with one patient who experienced this kind of blame-shifting firsthand.

After what was supposed to be a routine spinal fusion procedure, Natalie (not her real name) awoke in extreme pain. The neurosurgeon put her on steroids for pain relief. Two days later, a different neurosurgeon discovered in post-operative imaging that the surgeon who performed the procedure had put a screw inside Natalie’s spinal canal — far from where it should have been and a tiny distance from damaging her spinal cord.

The original surgeon’s explanation? “The screw migrated.” Buffalo and geese migrate. Medical screws placed properly and carefully into bone do not.

As patients, we are conditioned to assume that our doctors know best and always have our best interests in mind. When they refuse to own their mistakes, they betray that trust and foster an environment in which patient safety takes a backseat to doctors’ reputations.

The end result is a medical culture in which errors cause 250,000 deaths per year in the United States alone, making it the third leading cause of death, behind heart disease and cancer, according to research published last year by Dr. Marty Makary, a Johns Hopkins surgeon and outspoken patient safety advocate, and research fellow Michael Daniel.

What is a patient to do in this environment? The first thing is to be aware of your own predisposition to take everything your doctor says at face value. Listen closely and you may hear cause for more intense questioning.

You will likely never hear the terms negligence, error, mistake, or injury in a hospital. Instead, these harsh but truthful words and phrases are replaced with softer ones like accident, adverse event, or unfortunate outcome. If you hear any of these euphemisms, ask more questions or seek another opinion from a different doctor, preferably at a different facility.

Most doctors would never tell a flagrant lie. But in my experience as a neurosurgeon and as an attorney, too many of them resort to half-truths and glaring omissions when it comes to errors. Beware of passive language like “the patient experienced bleeding” rather than “I made a bad cut”; attributing an error to random chance or a nameless, faceless system; or trivialization of the consequences of the error by claiming something was “a blessing in disguise.”

When a serious preventable medical error occurs, the physician who made it always has the option to do the right thing and fully disclose what happened. He or she can make an honest apology, which must include accepting responsibility for the error. He or she can also explain what options are available for compensation. Anything less is a pseudo-apology at best and a cover-up at worst.

Lawrence Schlachter, MD, is a board-certified physician, a medical malpractice attorney, and the author of “Malpractice: A Neurosurgeon Reveals How Our Health-Care System Puts Patients at Risk” (Skyhorse Publishing, January 2017).

About the Author

Lawrence Schlachter

larry@schlachterlaw.com

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As More States Legalize, DEA Chops Down Fewer Marijuana Plants, Federal Data Shows

www.marijuanamoment.net/as-more-states-legalize-dea-chops-down-fewer-marijuana-plants-federal-data-shows/

The Drug Enforcement Administration (DEA) seized far fewer marijuana plants in 2018 compared to the previous year but made significantly more cannabis-related arrests, according to federal data released this month.

More than 2.8 million indoor and outdoor marijuana plants were seized last year as part of the DEA’s Domestic Cannabis Eradication/Suppression Program. That marks a 17 percent decline from 2017 levels.

NORML first noted the DEA report, which also shows that marijuana-related arrests the agency was involved with increased by about 20 percent in a year. And while the overall number of plants that were seized dropped, DEA said that the value of the assets totaled about $52 million—more than twice as much as it reported the previous year.

State-level legalization efforts appear to have played a role in the declining number of plant seizures, particularly those cultivated outdoors. In the same year that retail cannabis sales started in California, DEA confiscated almost 40 percent fewer outdoor plants in the state compared to 2017.

That data point is consistent with recent research showing that legalization is associated with a decrease in the number of illicit cannabis grows in national forests, which are often targets for DEA enforcement action.

It’s not clear why there was a significant uptick in marijuana-related arrests, but those increases generally did not occur in states where legal cannabis systems were recently implemented.

For example, arrests in Kansas, where marijuana is strictly prohibited, increased by more than 3,500 percent—from 15 to 544—from 2017 to 2018. Louisiana likewise experienced a 168 percent increase in cannabis arrests.

The data covers federal law enforcement actions and does not include those of local police agencies that did not partner with the agency.

Year-over-year decreases in cannabis seizures through DEA’s eradication program have been viewed by advocates as evidence that state-level legalization systems effectively displace the illicit market, removing the incentive to illegally cultivate cannabis.

Similarly, a separate recent report from the U.S. Sentencing Commission showed that federal prosecutions for marijuana trafficking dropped precipitously in 2018—another sign demonstrating that state-level legalization is disrupting the illicit market, advocates argue.

NORML Deputy Director Paul Armentano told Marijuana Moment that “federal eradication programs are a holdover from a bygone era.”

“At a time when roughly one-quarter of the country resides in a jurisdiction where adult marijuana use is legal, and when members of Congress are openly discussing removing cannabis from the federal Controlled Substances Act, it is time for these federal anti-marijuana efforts to be put out to pasture and for federal agencies to take positions that more closely comport with cannabis’ rapidly changing cultural status in America,” he said.

DEA has also faced criticism of its cannabis eradication efforts from a non-partisan federal watchdog agency last year for failing to adequately collect documentation from state and local law enforcement partners funded through the program.

The Government Accountability Office said in a report that DEA “has not clearly documented all of its program goals or developed performance measures to assess progress toward those goals.”

At the same time that DEA is seizing fewer plants grown illicitly, it’s also setting higher goals for federally authorized cannabis cultivation for research purposes. In 2019, the agency said it hoped to grow approximately 5,400 pounds of marijuana to meet research demand, which is more than double its quota for 2018.

 

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Four Tennessee pain clinics closing after arrests, fraud allegations

https://www.tennessean.com/story/news/health/2019/05/09/tennessee-pain-clinics-closing-painmd-rinova-fraud-allegations/1153043001/

Four Tennessee pain clinics have abruptly closed in the wake of federal authorities accusing executives and employees of inflating profits by giving patients thousands of worthless injections.

The clinics were formerly part of PainMD but were re-branded under the name Rinova after PainMD was accused of widespread fraud. The shuttered Rinova clinics are in Clarksville, Cookeville, Lawrenceburg and Tullahoma.

The clinics officially closed at the end of business on Wednesday. Some employees found out that same day the clinics were shutting down and they were losing their jobs. When contacted on Thursday morning, an employee said at least one clinic was minutes away from locking its doors for good.

Rinova is owned by Dr. Benjamin Johnson, a former PainMD executive who bought the four clinics in February when PainMD was quietly carved into thirds and sold off to company insiders. Johnson could not be reached for comment.

The abrupt closure of these clinics comes after months of escalating allegations against PainMD, which is headquartered in Franklin and at one point owned or managed as many as 30 pain clinics in Tennessee, North Carolina and Virginia. Both state and federal authorities have sued Pain MD alleging it committed health care fraud with bogus injections, and three PainMD nurse practitioners were criminally indicted for this same scheme last month. All three suspects have pleaded not guilty.

INVESTIGATION: Pain clinics, needles and greed: PainMD accused of injecting patients to meet profit quotas

It also appears that criminal investigation is climbing the company ladder. In the recent indictment, federal prosecutors also cast fraud allegations against the PainMD owner and chief medical officer, who are identified in court records by their job titles only. A separate, civil lawsuit related to the case identifies the owner of PainMD as Michael Kestner and the chief medical officer as Dr. Lisabeth Williams.

Over the past two weeks, the company has filed numerous court records under seal in an effort to hide the names of its leadership, arguing they would face “intense media scrutiny” and “damage to (their) personal and professional reputations” if they were identified as suspects in a criminal investigation.

Kestner and Williams have not been charged with any crime. U.S. Attorney Don Cochran has declined to say if they will face charges, but stressed that federal prosecutors have many ongoing investigations into medical practitioners.

PainMD’s attorney, Jay Bowen, did not immediately respond to a request for comment on Thursday.

The alleged PainMD scheme hinges on two pain-relieving injections that sound similar but are dramatically different when it comes to government reimbursement. The lawsuits say that PainMD staff gave patients “trigger point injections,” which government insurance programs will generally cover about four times a year, but intentionally mislabeled these injections as “tendon origin injections,” a more expensive procedure for which coverage is not capped. The result of the scheme, as alleged in court records, is that PainMD got rich, taxpayers got screwed and patients got jabbed with a needle over and over for no justifiable reason at all.

PAIN CLINICS: Feds to sue Sen. Steve Dickerson and other pain clinic owners over fraud, forgery allegations

Brett Kelman is the health care reporter for The Tennessean. He can be reached at 615-259-8287 or at brett.kelman@tennessean.com. Follow him on Twitter at @brettkelman.

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