CARROLL: Opioid guidelines to inflict more pain

Frank CarrollCARROLL: Opioid guidelines to inflict more pain

http://rapidcityjournal.com/carroll-opioid-guidelines-to-inflict-more-pain/article_e7e608f0-3a5e-5c08-bb88-d4dd19fb7b0b.html

Author and advocate for chronic-pain patients, Dr. Richard A. Lawhern, communicates daily with thousands of pain sufferers on Facebook and other social media. What he hears is a chilling and deepening fear for the future as people in pain are increasingly being denied effective treatment by their doctors and lawmakers.

In March 2016, the U.S. Centers for Disease Control and Prevention (CDC) issued guidelines for prescribing opioids to adult, non-cancer pain patients. These guidelines have greatly worsened conditions for pain sufferers by driving doctors out of pain-management practice and forcing major cutbacks in pain treatment.

In ongoing legislative discussions in South Dakota, Dr. Chris Dietrich warned the Department of Health and Human Services that the new rules would put many pain doctors out of business and ruin the lives of thousands of pain sufferers.

 In spite of his warnings, the South Dakota Legislature has passed laws that will severely curtail legitimate pain control while doing nothing for illegal drug use and addiction.

Patients who have successfully managed on opioids for decades are being deserted, often without withdrawal assistance and with no access to effective alternative pain therapies. Many are becoming disabled altogether, bedridden and losing their capacity to sustain employment or family relationships. Many are committing suicide, overcome by agonies imposed on them by their physicians and irresponsible government agencies. More are turning to suicide as this crisis continues and deepens. A frightening example is the more than 30 military members who commit suicide daily.

The CDC acknowledges their recommendations for guidelines are grounded on weak medical evidence. Previous research in Food and Drug Administration and National Institutes of Health studies was ignored. The guidelines also ignore the reality of a substantial cohort of patients among whom opioid treatment is both appropriate and the only resort after the failure of all other therapies. Addiction is not a problem for these patients: Pain is a life-threatening problem.

 
 The CDC content was unduly influenced by selecting anti-opioid advocates as primary participants in the core writers group. Writers’ utilized a biased selection of medical research to unfairly dismiss the effectiveness of opioids in treating chronic pain. They also inflated perceived risks of opioids. For example, in South Dakota last year only 25 deaths were attributed to opioids, with over half of those from heroin.

Although opioid-related deaths are a serious public health issue in some places, relatively few deaths are caused by drugs prescribed to legitimate pain patients. Deaths come from illegally imported fentanyl, heroin, and opioids diverted by theft or fraud.

There is no recognition of variances in opioid metabolisms among pain patients. The hard limit on prescribing opioids in the guidelines is not supportable scientifically.

Worse, the guidelines parrot unproven assertions that drug tolerance is universally experienced among chronic-pain patients — the more you take the more you need. This assertion is neither true nor proven in the literature or in practice.

The guidelines were originally meant as advisory information for general practitioners, subject to tailoring for each individual patient, never as a mandatory, one-size-fits-all restrictive edict. If made mandatory, the 90 morphine equivalent, an upper limit on opioid dose levels, will effectively destroy the lives of many tens of thousands of chronic-pain patients who have maintained at higher and stable doses for years.

Now, the HHS Centers for Medicare and Medicaid propose to integrate the March 2016 CDC guidelines as mandatory standards of practice in insurance reimbursement. This must not be allowed to happen. The only ethical way forward is to withdraw the guidelines for a total rewrite, this time led by board-certified pain-management specialists and chronic-pain patients themselves.

 Frank Carroll is a freelance writer and columnist. He can be reached by emailing frankcarrollpfm@gmail.com or visiting blackhillsforestpros.com.

Is this how the typical Board of Pharmacy protects pts ?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

This is from a quarterly newsletter (March 2017) https://nabp.pharmacy/boards-of-pharmacy/kentucky/ from the KY Board of Pharmacy, you may have to click on the image to make readable… It is a summary of the actions taken by the BOP for 2016… but notice next to last entry on left column… (UNPROFESSIONAL CONDUCT – FAILURE TO DISPENSE) …. 15 complaints… 14 DISMISSED…

No specifics on what was refused to dispensed… but… educated guess … most were controlled substances… if so… the BOP considers throwing a dependent pt into cold turkey withdrawal… acceptable professional conduct.

Expert: America’s heroin epidemic starts in Mexico

Expert: America’s heroin epidemic starts in Mexico

http://www.santafenewmexican.com/news/expert-america-s-heroin-epidemic-starts-in-mexico/article_0469d994-7d12-50df-9dd3-3dd8c6d6060b.html

America faces its worst drug crisis in decades, with heroin and opioid use tripling since 2010. As various federal agencies roll out their annual strategy reports, the government declared that-as was the case in previous drug frenzies-all of the heroin used in the U.S. comes from abroad. Only now, instead of Southeast Asia’s Golden Triangle or remote South America, the primary source is just next door, in a country with already delicate U.S. relations.

This week, the State Department delivered some 600 pages to Congress detailing the transnational drug trade, putting together data from the U.N., Drug Enforcement Administration, Immigration and Customs Enforcement, and a variety of other entities. “The opioid epidemic demands urgent action as a top priority of U.S. and international drug control efforts,” the report stated.

 

As much as 94 percent of the heroin entering America comes from Mexico, estimated William R. Brownfield, a man with a complex title (assistant secretary of the Bureau of International Narcotics and Law Enforcement Affairs) who sits at the fulcrum of drug interdiction and diplomatic initiative.

During a conference call Thursday, he explained that, in 2017, a synthetic opioid between 10 and 50 times more potent than heroin, raw fentanyl, is being trafficked through Mexico into the U.S. alongside heroin and cocaine, though it’s largely produced in Asia. (Other commonly known opioids are morphine, oxycodone, and tramadol.)

Between 1988 and 1994, Southeast Asia was the area of origin for the majority of wholesale heroin seizures in the U.S. Then it shifted to South America through 2010. Since then, Mexico has gained market share, according to data from the Heroin Signature Program cited by the DEA.

Between 2010 and 2015, heroin seizures in America increased from 2,763 kilograms to 6,722 kilograms, according to a November report from the DEA, indicating a surge of the drug entering the country. “The U.S. has seen substantial increases in heroin availability in the last seven to 10 years, which has allowed the heroin threat to expand to unprecedented levels,” the report stated. “Increases in heroin production in Mexico have ensured a reliable supply of low-cost heroin, even in the face of significant increases in user numbers.”

In 2007, there were 161,000 active heroin users in the U.S., compared with 435,000 in 2014. Overdose deaths involving heroin soared 248 percent between 2010 and 2014 and those involving synthetic opioids increased 79 percent between 2013 and 2014.

Brownfield, who was appointed in 2011 during the Obama administration, said President Donald Trump’s planned border wall with Mexico would be integrated into what he called an existing “wall” of cross-border law enforcement cooperation. He seemed noncommittal, however, on whether a real wall, meant largely to address illegal immigration, would have any decisive effect on heroin trafficking.

“As we have determined for more than 20 years, the U.S. and Mexico have shared responsibilities for this problem, and that requires shared solutions,” he said. “I actually believe that at this point in time, cooperation between the U.S. and Mexico on this matter, on the matter of drug production and drug trafficking, is at historically high levels.”

Brownfield, who after all is a diplomat of sorts, not only complimented Mexican cooperation, but also praised China-where much of the synthetic opioids are believed to be produced-and the U.N. for cooperating with federal efforts to curb drug trafficking. Trump has criticized America’s relationship with all three, particularly Mexico on immigration, China on trade, and the United Nations in general, referring to it as “a waste of time and money.”

Drug overdose fatality rate higher than suicides, cars, guns

Drug overdose fatality rate higher than suicides, cars, guns

https://www.axios.com/fatal-drug-overdoses-more-than-doubled-since-1999-2282883694.html

A new Centers for Disease Control and Prevention study shows the rate of fatal drug overdoses has more than doubled since 1999. Those between 55 and 64 years of age were the hardest hit. Rates increased for both males and females and increased across all age groups.

The 2015 rate for fatal drug overdoses is higher than deaths from suicides (13.4 deaths per 100,000) car accidents (11.1 deaths per 100,000) and firearms:

Data: Centers for Disease Control; Chart: Andrew Witherspoon / Axios

Why this matters: The overall number of opioid overuse deaths quadrupled during the same time period, and in 2015 opioids killed more than 33,000 people — higher than ever before. States that Trump won like West Virginia, Kentucky, and Ohio were hardest hit by fatal drug overdoses in 2015. Trump held a meeting in Feb. at the White House on how to respond to the opioid epidemic.

A key takeaway: The portion of fatal drug overdoses due to more lethal drugs is increasing, and it coincides with new CDC restrictions on prescribing pain meds (like semisynthetic opioids morphine or oxycodone) issued last year, per STAT. In sum, users had to turn to other drugs, like heroin, to feed their addiction.

  • The portion of fatal overdoses due to heroin tripled from 8 percent in 2010 to 25 percent in 2015
  • The portion due to synthetic opioids (like fentanyl) jumped from 8 percent to 18 percent. This is a big deal because synthetic opioids can be 50 to 100 times more potent than heroin, which puts emergency rooms at risk of running out of antidotes to treat overdoses

Memo to Congress: DEA Dumped the “Gateway-Theory” Due to Science

Memo to Congress: DEA Dumped the “Gateway-Theory” Due to Science

http://www.thedailychronic.net/2017/69978/memo-to-congress-dea-dumped-the-gateway-theory-due-to-science/

WASHINGTON, DC — Americans for Safe Access, a national nonprofit dedicated to ensuring safe and legal access to medical cannabis for therapeutic use and research, has sent a memo to Congress informing members that the Drug Enforcement Administration (DEA) has removed false information about cannabis from its website after months of public pressure. The memo explains:

Forty-four states now allow patients under their physician’s care to use medical cannabis (marijuana) in some form, and the majority of the rest of the states are discussing medical cannabis in their current legislative sessions. In addition, three cannabis related budget amendments and four bills have been introduced so far in the 115th Congress.

We know that you rely on the Drug Enforcement Administration (DEA) to provide current and accurate information when you are making decisions about cannabis policy. Americans for Safe Access (ASA) has prepared this memo to inform you about four important changes in the DEA’s positions on medical cannabis that could have an impact on your policy making decisions this session.

The change comes after Americans for Safe Access filed a legal request with the Department of Justice last year demanding that the DEA immediately update and remove factually inaccurate information about cannabis from their website and materials.

The group argued that the document formerly known as “The Dangers and Consequences of Marijuana Abuse,” contained several inaccurate claims about cannabis and was in violation of the Information Quality Act (IQA, aka Data Quality Act), which requires that administrative agencies to provide accurate information to the public and that they respond to requests for correction of information within 60 days.

“We know that members of Congress rely on the DEA to provide current and accurate information when enacting drug policies, and cannabis is no different,” said Beth Collins, Senior Director of Government Relations and External Affairs at Americans for Safe Access. “More specifically, we prepared this document to help inform Congress about four important changes in the DEA’s positions on medical cannabis that could have an impact on their policy making decisions this session: cannabis is not a “gateway drug” and it does not cause cognitive decline, psychosis or lung cancer.”

“While we are still waiting for the final response from the DEA regarding their plans to update or remove the remaining misinformation on their website, we know that legislators are being asked to make decisions on cannabis policy now. It is our hope that this document will provide a better understanding of the status of science on these important matters,” added Collins.

The DEA slowed enforcement while the opioid epidemic grew out of control

The DEA slowed enforcement while the opioid epidemic grew out of control

http://s.nola.com/qFSpo0E

A decade ago, the Drug Enforcement Administration launched an aggressive campaign to curb a rising opioid epidemic that was claiming thousands of American lives each year. The DEA began to target wholesale companies that distributed hundreds of millions of highly addictive pills to the corrupt pharmacies and pill mills that illegally sold the drugs for street use.

Leading the campaign was the agency’s Office of Diversion Control, whose investigators around the country began filing civil cases against the distributors, issuing orders to immediately suspend the flow of drugs and generating large fines.

But the industry fought back. Former DEA and Justice Department officials hired by drug companies began pressing for a softer approach. In early 2012, the deputy attorney general summoned the DEA’s diversion chief to an unusual meeting over a case against two major drug companies.

“That meeting was to chastise me for going after industry, and that’s all that meeting was about,” recalled Joseph Rannazzisi, who ran the diversion office for a decade before he was removed from his position and retired in 2015.

Rannazzisi vowed after that meeting to continue the campaign. But soon officials at DEA headquarters began delaying and blocking enforcement actions, and the number of cases plummeted, according to on-the-record interviews with five former agency supervisors and internal records obtained by The Washington Post.

The judge who reviews the DEA diversion office’s civil caseload noted the plunge.

“There can be little doubt that the level of administrative Diversion enforcement remains stunningly low for a national program,” Chief Administrative Law Judge John J. Mulrooney II wrote in a June 2014 quarterly report obtained under the Freedom of Information Act.

In fiscal 2011, civil case filings against distributors, manufacturers, pharmacies and doctors reached 131 before dropping to 40 in fiscal 2014, according to the Justice Department. The number of immediate suspension orders, the DEA’s strongest weapon of enforcement, dropped from 65 to nine during the same period.

“Things came to a grinding halt,” said Frank Younker, a DEA supervisor in the Cincinnati field office who retired in 2014 after 30 years with the agency. “I talked to my fellow supervisors, and we were all frustrated. It was ridiculous. I don’t know how many lives could have been saved if the process was done quicker.”

The slowdown began in 2013 after DEA lawyers started requiring a higher standard of proof before cases could move forward.

Top officials at the DEA and Justice declined to discuss the reasons behind the slowdown in the approval of enforcement cases. The DEA turned down requests by The Post to interview Mulrooney, acting DEA administrator Chuck Rosenberg, chief counsel Wendy Goggin and Rannazzisi’s replacement, Louis J. Milione.

The agency provided a statement from Rosenberg:

“We combat the opioid crisis in many ways: criminally, civilly, administratively, and through robust demand reduction efforts.

“We implemented new case intake and training procedures for our administrative cases, increased the number of enforcement teams focused on criminal and civil investigations, restarted a successful drug take back program, and improved outreach to – and education efforts with – our registrant community.

“We have legacy stuff we need to fix, but we now have good folks in place and are moving in the right direction.”

The Justice Department, which oversees the DEA, declined requests to interview Attorney General Loretta Lynch and Deputy Attorney General Sally Q. Yates.

The department issued a statement saying that the drop in diversion cases reflects a shift from crackdowns on “ubiquitous pill mills” toward a “small group” of doctors, pharmacists and companies that continues to violate the law.

Justice Department spokesman Peter Carr said diversion investigators are also increasingly using criminal procedures to force targets to surrender their licenses without administrative hearings.

“Although these reasons largely account for the decline in administrative case filings, the department remains committed to eliminating the problem of opioid abuse,” Carr said, pointing out that the diversion control chief had recently been elevated to a “top leadership post.”

But Justice statistics show that surrenders of licenses have remained relatively constant since 2011 before dropping by more than a third in the last fiscal year. Carr could not say how many were tied to DEA enforcement actions. The former agency supervisors said the majority of surrenders do not involve DEA enforcement actions.

The epidemic began in the late 1990s after the introduction of the powerful, long-acting opioid OxyContin and an aggressive marketing campaign by the drug’s manufacturer, Purdue Pharma, to persuade doctors to prescribe it for all kinds of pain. A new philosophy of pain management resulted in a surge in demand and the U.S. addiction rate.

From 2000 to 2014, 165,000 people died of overdoses of prescription painkillers nationwide. The crisis has also fostered follow-on epidemics of heroin, which caused nearly 55,000 overdose deaths in the same period, and fentanyl, which has killed thousands more. The number of U.S. opioid prescriptions has risen from 112 million in 1992 to 249 million in 2015.

Several DEA officials on the front lines of the opioid war said they could not persuade headquarters to approve their cases at the peak of the epidemic. They said they confronted Clifford Lee Reeves II, a lawyer in charge of approving their cases, to no avail. Through a DEA spokesman, Reeves declined to comment for this report.

Jim Geldhof had been with the DEA for nearly four decades and was serving as the diversion program manager in the Detroit field office when Reeves took over at DEA headquarters in 2012.

“It was like he was on their side, not ours,” said Geldhof, who retired in January. “I don’t know what his motive was, but we had people dying. You’d think he’d be more aggressive. We were in the throes of a major pill epidemic.”

In the field, Younker and other DEA supervisors said they grew to distrust Reeves and became suspicious about what was taking place at headquarters.

“We all had a feeling that someone put him there to purposely stonewall these cases,” Younker said.

Kathy Chaney, who served as the DEA’s group supervisor in Columbus, Ohio, saw the problem play out firsthand. She was responsible for 35 counties in Ohio and had overseen the agency’s efforts to curb prescription painkiller abuse in cities such as Chillicothe and Portsmouth, both at ground zero of the opioid crisis.

She said one of her cases against a distributor languished for years without action. The experience was particularly difficult, Chaney said, because she had been meeting with parents of children who had died of overdoses of oxycodone and other painkillers.

“We got so frustrated, I finally told my group, ‘We’re not going to send any cases up to headquarters,’ ” said Chaney, who retired in 2013. “In 25 years, I had never seen anything like it. It was one of the reasons I left. Morale was terrible. I couldn’t get anything done. It was almost like being invisible.”

– – –

In 2004, the leaders of the DEA’s diversion office became alarmed by the rising number of overdose deaths amid a growing supply of prescription painkillers. Online pharmacies were flourishing, making it easy to buy powerful painkillers such as oxycodone and hydrocodone. The death toll had hit 8,577, a 15 percent jump in one year.

Pain-management clinics began popping up around the country. DEA diversion investigators soon realized that they were playing a real-life game of Whac-a-Mole. As soon as they shut down one facility, another would appear.

“People were dying,” said William Walker, a 31-year DEA veteran who headed the diversion office in 2004 and 2005.

Walker set up tactical units around the country to investigate doctors, pharmacists, distributors and manufacturers.

“We had a multilayered threat, and there was a tremendous sense of urgency,” he said. “I turned up the heat on the workforce, and we started getting after it.”

Toward the end of 2005, Walker, a brigadier general in the National Guard, was called up for active duty and left the office. Taking his place was his top deputy, Joseph Rannazzisi, a street-smart New Yorker who held degrees in pharmacy and law. He had begun his career as a DEA street agent and then a supervisor in Detroit before working his way to the top of the diversion office at the agency’s headquarters in Arlington, Va.

Rannazzisi decided to focus on the source of the pills: the wholesale distributors of pharmaceuticals.

Drugs are manufactured by high-profile corporations such as Purdue Pharma. They rely on a lesser-known network of distributors, some of which are also multinational corporations. The distributors serve as middlemen, sending billions of doses of opioid pain pills to pharmacists, hospitals, nursing homes and pain clinics. The U.S. prescription opioid market generates $10 billion in annual sales.

There are thousands of distributors among the 1.6 million people and companies that hold DEA licenses to dispense drugs, but three of them – McKesson, AmerisourceBergen and Cardinal Health – account for 85 percent of the drug shipments in the United States. These companies, which together collect about $400 billion in annual revenue, supply the corner pharmacist as well as giant medical centers.

For years, the DEA had taken a hands-off approach to the prescription drugs flowing out of the distributors. The companies had been reporting their drug sales inconsistently or not at all. They had been largely left alone as the DEA focused on doctors and pharmacies.

“The distributors had been ignored for years and years and years,” John Coleman, the third-ranking administrator at the DEA in the mid-1990s, said in a recent interview.

In 2005, the Office of Diversion Control, under Rannazzisi, launched its “Distributor Initiative” and briefed 76 companies about it. The new campaign pitted the DEA against an industry with close ties to lobbyists, lawyers and politicians in Washington.

On Sept. 27, 2006, the diversion office sent a letter to distributors across the country, reminding them that they were required by law to ensure that their drugs were not being diverted to the black market.

“Given the extent of prescription drug abuse in the United States, along with the dangerous and potentially lethal consequences of such abuse, even just one distributor that uses its DEA registration to facilitate diversion can cause enormous harm,” Rannazzisi wrote in the letter.

Five months later, D. Linden Barber, then-associate chief counsel for the DEA diversion office, wrote to DEA supervisors across the country, telling them to be vigilant. Abuse of prescription drugs, he said, had become “greater than the abuse of cocaine, heroin and methamphetamine.”

Under Rannazzisi’s initiative, distributors would have to monitor their sales in real time, withhold drug shipments if they detected suspicious activity and report those red flags to the DEA.

The diversion office deployed two weapons to ensure compliance. The first was an “order to show cause,” which permits investigators to begin a process to stop drug shipments from warehouses. The second was an “immediate suspension order,” which allows the DEA to instantly freeze shipments of narcotics from facilities where an “imminent threat” to public health exists. The immediate suspension order was especially dreaded by the distributors.

Younker, the former DEA supervisor in Cincinnati, said the agency had no other choice.

“The distributors could have stopped what was going on, but they didn’t,” he said. “They were doing the bare minimum. Why would you want to cut off a customer that’s paying you $2 million a year? They have sales reps and sales quotas and bonus structures and employees of the month. Everyone was making a lot of money.”

The DEA diversion office started small. Investigators targeted Southwood Pharmaceuticals, a mom-and-pop distributor in Lake Forest, Calif., where shipments of hydrocodone had skyrocketed over nine months in 2005, from 7,000 doses per month to 3 million. Southwood eventually lost its license to dispense controlled substances.

In 2007, the DEA raised its sights, bringing an enforcement case against McKesson – now the nation’s largest drug distributor and the fifth-largest corporation in the country. The DEA accused the company of failing to report hundreds of suspicious orders from online pharmacies.

“As a result, millions of dosage units of controlled substances were diverted from legitimate channels of distribution,” a Justice Department news release said in 2008. Without admitting liability, McKesson eventually settled the case, agreeing to pay a $13 million fine.

That same year, the diversion office filed a case against Cardinal Health, another member of the Big Three wholesalers. DEA investigators alleged that the company was sending millions of doses of painkillers to online and retail pharmacies without alerting investigators to an obvious sign of illegal diversion.

Cardinal settled the allegations in 2008, paying a $34 million fine without acknowledging wrongdoing and promising to improve its monitoring of suspicious orders. Cardinal’s chief executive at the time said the company had spent $20 million to control diversion and took its responsibility “very seriously.”

Still, the painkiller crisis raged. In 2008, 13,149 people died of opioid overdoses.

The next year, a federal law made it illegal to distribute controlled substances online and required doctors to see their patients face-to-face before writing prescriptions.

By now, the DEA’s campaign was broad and deep. Mulrooney, the agency’s chief law judge, noted in an internal report that the agency had filed 115 charging documents in 2010, including 52 immediate suspension orders.

“Progress,” the chief judge wrote, noting that all pending cases were scheduled for hearings. “This has not been true for as long as anyone here can remember.”

In late 2011, Rannazzisi’s office filed warrants to yet again inspect the records of a Cardinal warehouse. Investigators alleged that the company was overlooking escalating oxycodone orders from pharmacies in Florida. The DEA was also targeting four drugstores supplied by Cardinal in the state, including two CVS pharmacies.

Rannazzisi’s office obtained an internal Cardinal email from 2010 showing that the company’s own investigator had warned against selling narcotics to Gulf Coast Medical Pharmacy, an independent drugstore in Fort Myers, Fla., citing suspicions that the pills were winding up on the street.

Despite the warning, Cardinal hadn’t notified the DEA or cut off the supply of drugs.

Instead, the company shipped increasing quantities of pain pills to Gulf Coast. In 2011 alone, Cardinal sent more than 2 million doses of oxycodone to Gulf Coast. The wholesaler typically shipped 65,000 doses annually to comparable pharmacies.

“I had the case of my dreams,” Rannazzisi said.

About Thanksgiving in 2011, Rannazzisi said that he received an unexpected phone call.

It was from James Dinan, then-chief of the Organized Crime Drug Enforcement Task Forces program at the Justice Department. Dinan worked with then-Deputy Attorney General James Cole, the second-most powerful Justice Department official after Attorney General Eric Holder Jr.

Rannazzisi said Dinan told him: “We’re getting calls from attorneys, former Justice people, that are saying you guys are doing some enforcement action.”

Rannazzisi said he told Dinan that warrants for Cardinal records had already been served.

Among the attorneys representing Cardinal at the time were two former deputy attorneys general, Jamie Gorelick, who served in the Clinton administration, and Craig Morford, who served in the George W. Bush administration. Both contacted the DEA, records show.

Gorelick did not respond to requests for an interview. Morford declined to comment. Instead, Cardinal referred questions to Barber, the former DEA associate chief counsel in charge of diversion litigation, who joined the law firm Quarles & Brady and is now representing distributors.

Barber told The Post that there was nothing unusual about Morford contacting the agency.

“It was not anything other than ‘we’d like to sit down and have a discussion at an early stage of the investigation,’ ” Barber said.

On Feb. 1, 2012, as Rannazzisi was preparing to sign off on immediate suspension orders against Cardinal and CVS, he said he received another call from Dinan.

Rannazzisi said Dinan told him that Cole, the deputy attorney general, known in the department as the “DAG,” was demanding a briefing before the suspension orders were executed.

The next morning, at 1:36 a.m., Dinan followed up with an email.

“Please call me in the morning,” he wrote, according to Rannazzisi. “I want to make double sure nothing unreversible happens before the DAG is briefed as we talked about at Thanksgiving.”

That morning, Rannazzisi went to the Justice Department in Washington to meet with a number of officials, including Cole; Dinan; Goggin, the DEA’s top lawyer; and Stuart Goldberg, Cole’s chief of staff.

Rannazzisi said Goldberg did most of the talking.

“He asked me a question about what my goals were in this case, and why I was going after these corporations,” Rannazzisi said. “I said, ‘Before I answer that, I’ve got to ask you: I’ve done hundreds of these cases, and I’ve never been called over to the Justice Department to explain myself. I’m just curious why this case is so important.’ “

Rannazzisi said Cole interrupted.

“Because I’m the deputy attorney general of the United States, and I want to know about it,” he recalled Cole saying.

“Then I say, ‘Well, that doesn’t really answer the question,’ ” Rannazzisi said.

The meeting went downhill from there,

“It spiraled out of control,” Rannazzisi said. “It got very adversarial.”

Cole, who is now a partner at the Washington law firm Sidley Austin, disputed Rannazzisi’s characterization of the meeting.

“My conversation with Mr. Rannazzisi was simply to confirm whether or not he had refused to meet with Cardinal regarding a potential DEA action and, if so, share my view that it made good sense to listen to what Cardinal had to say,” Cole said in a statement.

“Hearing what Cardinal had to say could inform DEA of facts they may not have known. I did not tell Mr. Rannazzisi how to come out on the Cardinal matter and certainly did not discourage him from going after any company in violation of any statutes or regulations,” he said.

Dinan, now the principal assistant U.S. attorney for the District of Columbia, declined to comment through a spokesman. Goldberg and Holder did not respond to requests for an interview.

Rannazzisi said he left the meeting undeterred. The same day, his office filed the suspension order against Cardinal, and two days later, DEA investigators shut down the two CVS pharmacies. A week later, DEA officials said in court documents that Cardinal’s activities constituted “an imminent danger to the public health or safety.”

As the cases were pending, Goggin wrote to Rannazzisi to inform him that CVS was attempting to go around the agency by appealing to the office of the deputy attorney general, known as ODAG.

“CVS lawyers (who used to work at DOJ) are trying to do an end run with ODAG,” Goggin wrote, according to Rannazzisi. “They want (1) to get the administrator to hold off issuing a final order until we are able (presumably) to try and work out a settlement.”

In his statement, Cole said, “I do not recall having any involvement with CVS matters while at DOJ.”

Final orders make cases public because the decisions are published in the Federal Register. A final order was issued against CVS, which ultimately paid a $22 million fine.

In 2012, Cardinal also reached a settlement. A company spokesman recently told The Post that Cardinal uses state-of-the-art techniques, including advanced analytics, to combat diversion.

To date, the company has not been fined. A federal prosecutor and company officials said negotiations are continuing.

In December 2012, a new lawyer filled the position in charge of approving cases brought by the DEA’s diversion office. A career employee of the Justice Department, Clifford Reeves had worked on the case against CVS. At first, diversion investigators were encouraged by the arrival of an experienced lawyer.

But soon, complaints arose in some of the DEA’s field offices around the country. Under Reeves, DEA attorneys began demanding additional evidence before investigators could take action.

“After Reeves arrived, everything became confrontational,” Geldhof, the retired DEA diversion manager in Detroit, recalled in a recent interview. “There were a lot of roadblocks all the time. Everything was an issue.”

Before Reeves’s arrival, Geldhof said, investigators had to demonstrate that they had amassed “a preponderance of evidence” before moving forward with enforcement cases, which are administrative, not criminal. Under Reeves, Geldhof said, investigators had to establish that their evidence was “beyond a reasonable doubt,” a much higher standard used in criminal cases.

Geldhof said he repeatedly confronted Reeves about the languishing cases.

“I said, ‘Lee, what’s going on?’ ” Geldhof said.

He said Reeves simply told him about the new higher standard.

Barbara Heath, a DEA program manager in Atlanta, said she and her investigators were frustrated by the new policy in Washington.

“It was the most significant change in my 20 years at the DEA,” said Heath, who oversaw the agency’s diversion efforts in Georgia, the Carolinas and Tennessee from 2006 until her retirement in December. “It got to the point where they wanted the same evidence as criminal prosecutions. It was very difficult to prove intent.”

In Washington, Mulrooney, the chief DEA judge, was documenting the falling caseload. In a June 24, 2013, quarterly report, Mulrooney wrote that there was “a significant drop” in the number of “orders to show cause.” Four months later, he noted “a free fall in the numbers of charging documents.” For the first time since records had been kept, he noted, no charging documents had been filed for an entire month.

Younker, the retired DEA supervisor in Cincinnati, said he, too, called Reeves to complain.

“Look, these cases are lingering here, they’re down in your shop for six to 12 months,” Younker recalled telling Reeves. “They’re sending drugs out and people are dying, and this is like the emperor has no clothes on.”

Younker said Reeves replied: “Who’s the emperor?”

“I said, ‘You’re the emperor. You can’t sit on these things like this.’ “

Seeing what was happening in the field, Rannazzisi said he became furious with Reeves.

“At one point, I said: ‘I’ve lost all faith in the counsel, and you’ve become a hindrance and not a help, and all these people are dying,’ ” Rannazzisi said.

Chaney, the former DEA supervisor in Columbus, said her office in 2011 began investigating an Ohio distributor that sent tens of millions of pain pills to doctors and pharmacies in Florida over three to four years.

Chaney said there was no reason to ship that many pills to Florida from Ohio, because the company already had a distribution facility in Florida. The DEA also had previously taken action against some of the doctors who were writing prescriptions for opioids filled by the Florida pharmacies.

“It was a righteous case,” she said.

But the lawyers at DEA headquarters disagreed. The original DEA attorney assigned to the case was removed and replaced by a lawyer who stalled the case at every turn, Chaney said.

“It was never enough,” she said. “We could never satisfy them.”

Chaney declined to identify the company because no legal action was taken.

At the end of 2013, she retired from the DEA.

“We were all very dedicated, and we were all deeply disappointed that the program was being manipulated this way,” she said.

Chaney said she had joined the DEA because of a personal loss: Her mother became addicted to Percocet after a car accident and died of an accidental overdose.

“That’s the reason I got into this work,” she said. “To see this happening, it makes me want to cry.”

In Washington, Mulrooney was becoming increasingly frustrated, his quarterly reports show. In a June 24, 2014, report, the judge wrote that the DEA’s legal office had filed only seven show-cause orders and one immediate suspension order in the previous three months.

“These numbers continue to reflect an alarmingly low rate of Agency Diversion enforcement activity on a national level relative to historical data,” Mulrooney wrote.

He noted that the drop in cases coincided with “a leadership transition” in the legal office. He wrote that he couldn’t determine who was to blame – the field offices or the lawyers at headquarters. Mulrooney divided the operating budget of the legal office by the number of cases it was approving. He found that each case was costing taxpayers nearly $11 million.

“Assuming also that opioid-related deaths remain at over 20,000 per year (2010-2011 levels), this would mean that the Agency is on course to institute one administrative enforcement action for every 625 fatalities,” he wrote.

Three months later, Mulrooney reported that the diversion caseload was so low, his judges had little to do. He began permitting them to hear cases from other federal agencies, including the Bureau of Prisons and the Treasury Department.

In the summer of 2014, Rannazzisi said that he received an unusual request. To foster better relations with industry, the Justice Department wanted to meet with senior representatives of drug distributors and pharmacy chains.

Rannazzisi said he was appalled. Some of the companies were either under investigation or in the midst of settlement negotiations with the DEA diversion office, he said.

But Rannazzisi said that he objected and that the meeting did not take place.

That summer, lobbying by the pharmaceutical industry intensified on Capitol Hill. Several members of Congress, led by Reps. Tom Marino, R-Pennsylvania, and Marsha Blackburn, R-Tennessee, were proposing a measure that critics said would undercut the DEA’s ability to hold drug distributors accountable.

Four major players lobbied heavily in favor of the legislation, called the Ensuring Patient Access and Effective Drug Enforcement Act. Together, McKesson, AmerisourceBergen, Cardinal and the distributors’ association, the Healthcare Distribution Alliance, spent $13 million lobbying House and Senate members and their staffs on the legislation and other issues between 2014 and 2016, according a Post analysis of lobbying records.

In July 2014, Rannazzisi was asked to explain his opposition to the bill in a conference call with congressional staffers.

“I said, ‘This bill passes the way it’s written we won’t be able to get immediate suspension orders, we won’t be able to stop the hemorrhaging of these drugs out of these bad pharmacies and these bad corporations,’ ” Rannazzisi recalled telling them. ” ‘What you’re doing is filing a bill that will protect defendants in our cases.’ “

His remarks enraged Marino, the chairman of the House Judiciary subcommittee on regulatory reform.

In a Sept. 18, 2014, congressional hearing, Marino tore into then-DEA Administrator Michele Leonhart, Rannazzisi’s boss. By then, the legislation had passed the House; the bill was about to be introduced in the Senate.

“It is my understanding that Joe Rannazzisi, a senior DEA official, has publicly accused we sponsors of the bill of, quote, ‘supporting criminals,’ unquote,” Marino said. “This offends me immensely.”

Marino told Leonhart that Congress was sending the DEA a message: “You should take a serious look at your regulatory culture and seek collaboration with legitimate companies that want to do the right thing.”

Marino mentioned Holder’s desire to meet with representatives of the pharmaceutical industry. At a hearing, Marino said he was “disappointed that DOJ staff has not made this a priority.”

Seven days later, Marino and Blackburn, who represent districts in states that have been hit hard by the opioid epidemic, demanded that the Justice Department’s inspector general investigate Rannazzisi’s remarks. They said he had tried to “intimidate” members of Congress. An investigation was launched. Rannazzisi was replaced in August 2015 and retired last October.

“That led to his undoing,” said Matthew Murphy, a DEA official who worked with Rannazzisi in the diversion office. Rannazzisi had “very, very strong views” on what was happening on the street, Murphy said. “He wasn’t going to change his opinion because of some heat.”

Marino said the conflict boils down to one person – Rannazzisi.

“We had a situation where it was just out of control because of [Rannazzisi],” Marino said. “. . . His only mission was to get big fines. He didn’t want to [do] anything but put another notch in his belt.”

The legislation passed in 2016. It raises the standard for the diversion office to obtain an immediate suspension order. Now the DEA must show an “immediate” rather than an “imminent” threat to the public, a nearly impossible burden to meet against distributors, according to former DEA supervisors and other critics. They said the new law gives the industry something it has desperately sought: protection from having its drugs locked up with little notice.

DEA officials, who declined to speak on the record, said the agency retains its power to issue immediate suspension orders under the new law.

Four months after Rannazzisi left, representatives from drug distributors and pharmacy chains got the meeting they had long wanted with key government officials, including Rosenberg, the acting DEA administrator, and Milione, Rannazzisi’s replacement.

Afterward, the DEA issued a news release declaring that it had established a new relationship with the companies.

“The pharmaceutical industry has a vital role on the front lines of preventing drug misuse and abuse across America, as do we,” Rosenberg said in the release, “and we plan to work closely with them.”

The new relationship had been in the making for years.

“One longstanding Congressional criticism of DEA’s diversion control division has been a lack of communication with its registrants,” Carr, the Justice Department spokesman, said in the recent statement. “Upon his arrival at DEA in May 2015, in response to these concerns, Acting Administrator Rosenberg made it a priority to improve communication with registrants and strengthen partnerships with the regulated industry.”

John Gray, president and chief executive of the Healthcare Distribution Alliance, the wholesalers’ trade association, praised the new approach.

“HDA is pleased with the willingness of the new leadership at the DEA to meet with and engage registrants, and is encouraged by the Administration’s desire to ‘reset the relationship’ with our industry,’ ” Gray said in a recent statement to The Post.

Rannazzisi said he views the new relationship as a surrender to industry.

“This idea that they’re going to say, ‘I’m sorry I violated the law, give me another chance and I’ll make it right,’ without having some type of punishment, to me is outrageous,” he said. “Every time I talked to a parent who lost a kid, I’m pretty sure they didn’t want me to say, ‘Oh, give them another chance because corporate America needs another chance.'”

 

 

Comment on Patient Protection and Affordable Care Act; Market Stabilization

Comment on Patient Protection and Affordable Care Act; Market Stabilization

http://cqrcengage.com/uspainfoundation/app/onestep-write-a-letter?0&engagementId=306575

Proposed Rule Does not Consider Impacts on Pain Patients

People living with pain, including you or your loved ones, are constantly learning of new policies, proposals and guidelines relating to the nation’s healthcare system. Unfortunately, such reform or recommendations are made too quickly and without regard for the chronic pain community.

U.S. Pain Foundation is a member of the I Am Essential coalition, a broad group of patient and community organizations representing millions of patients and their families. We support access and coverage for healthcare needs of individuals living with chronic conditions and disabilities.

Fellow coalition member, The American Cancer Society Cancer Action Network (ACS CAN) drafted a sign-on letter and a template that we can submit to the U.S. Department of Health and Human Services, in response to its Marketplace Stabilization Proposed Rule.

The proposed changes address issuers’ business concerns, but fails to create protections for pain patients if some of those measurements are implemented. That’s why U.S. Pain has signed the I Am Essential sign-on letter.

Now, we’re turning to our pain ambassadors, advocates and volunteers to submit ACS-CAN’s pre-written letter to the HHS today, as the deadline to submit public comments is tomorrow (Tuesday, March 7th).

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Some bureaucrats’ beliefs about MJ is still in early 20th century ?

Now Is The Time For Medicinal Cannabis

http://www.chattanoogan.com/2017/3/6/343278/Now-Is-The-Time-For-Medicinal-Cannabis.aspx

Tennessee Department of Health Commissioner John Dreyzehner has stated that expanding medical marijuana does more harm than good to any additional legalization. In our opinion, the swamp of deceit foisted on Tennesseans could not get any deeper. 

“Currently, the weight of evidence is that when marijuana is used as medicine, it will do more harm than good to the overall population of our state,” Commissioner Dreyzehner said. 

Commissioner Dreyzehner’s opinion is a bit out of date – about 25 years out of date and decidedly out of step with medical professionals and citizens of our state. 

 

As Dr. Sanjay Gupta of has said: “I am here to apologize. We have been terribly and systematically misled for nearly 70 years in the United States (regarding cannabis), and I apologize for my own role in that.” 

Physician support for medicinal cannabis mirrors the same (75-80 percent) support as the general public holds.  Safe Access Tennessee, a non-profit group devoted solely to medicinal cannabis (not recreational legalization), would like citizens and our state legislators to examine certain significant and material facts with respect to medicinal cannabis. 

The key rationale for a state medicinal cannabis program is to protect our state’s citizens from out-of-touch and distant federal bureaucracies, particularly the Drug Enforcement Agency and its related entities, which have fought a 45 year losing battle against the cannabis plant. This campaign of “systematically misleading” started with the proposition there is no medicinal value in cannabis. 

The falsehood that there is no medicinal value in cannabis is written into U.S. federal law and has been a consistent theme to justify large governmental budgets for law enforcement. Every medical advance related to cannabis has been opposed, slowed, delayed and harassed by DEA officials more dedicated to their bureaucratic power than patients’ suffering or the advancement of medicine. That is what Dr. Gupta means by “systematically misleading.” 

The Federal stranglehold on cannabis continued even after the discovery of the Endocabannioid System in 1989. This unique system of the human body controls the immune system, appetite, and pain (separately from the central nervous system), and is one of the most important scientific discoveries of the 20th century. It seems God designed our bodies to use cannabinoids (inherent in cannabis and other plants) to maintain health – the exact opposite of the DEA propaganda. (E.g., cannabis kills cancer cells by balancing the body’s immune functions – a scientific fact) 

The ECS was discovered over 25 years ago and only two FDA medicines have been approved when a free market could have generated hundreds if not thousands of viable medical alternatives. State medical cannabis programs are essential to the advancement of medicine for mankind. 

The large medicinal potential of the ECS is being squandered by highly paid federal bureaucrats. The DEA stopped research authorized by the 2014 legislative session of the State of Tennessee (SB 2531) by not allowing cannabis to be grown at Tennessee Tech for academic research purposes.  Our State legislature cannot let these restrictions on medical and scientific advancement stand. 

Tennessee needs a medicinal cannabis program just to maintain our economic competitiveness in the area of advanced ECS health solutions. Nashville is the leading healthcare investment location in the country and our state laws needs to support this critical industry. We should restore our medical and economic freedom by passing and implementing the Medical Cannabis Act of 2017.as a whole. 

David C. Hairston, CPA
Chairman of the Board for Safe Access Tennessee, an advocacy group affiliated with the Americans for Safe Access

Communications breakdown between DEA, ATF allowed gun trafficker, drug dealer to walk free

Undated photo of Manuel Gomez Barba (Photo: The Houston Chronicle)

Communications breakdown between DEA, ATF allowed gun trafficker, drug dealer to walk free

http://www.guns.com/2017/03/06/communications-breakdown-between-dea-atf-allowed-gun-trafficker-drug-dealer-to-walk-free/

A federal investigation reveals a communications breakdown between the Drug Enforcement Administration and the Bureau of Alcohol, Tobacco, Firearms and Explosives allowed a known drug dealer and suspected gun trafficker to walk free.

Seven months later, firearms recovered from a crime scene in Mexico where two federal agents were attacked would implicate the very same man in a scheme to smuggle guns across the border.

Los Zetas gang members gunned down Immigration and Customs Enforcement agents Victor Avila and Jaime Zapata on a highway 200 miles north of Mexico City on Feb. 15, 2011, killing Zapata and wounding Avila. Investigators later traced one of the weapons used in the crime to a straw purchaser in Texas named Robert Riendfliesh, who bought the firearm from a pawnshop in Beaumont under the direction of Manuel Gomez Barba.

Barba ran a straw purchasing ring in eastern Texas authorities dubbed “the Baytown Crew,” collecting guns eventually smuggled across the border to Mexican drug cartels.

DEA agents arrested Barba during an undercover narcotics operation in June 2010, three weeks after Barba told a confidential source he not only supplied methamphetamine in Beaumont, but was involved in a firearms deal involving 20 AK-47s, according to a report released last week by the Office of Inspector General.

Sean O’Neill, deputy assistant inspector general, said during an interview last week DEA agents didn’t immediately forward Barba’s statements about weapons dealing to agents at the ATF or to the U.S. Office of Attorneys for the Eastern and Southern Districts of Texas because they “weren’t believed to be credible.”

After agreeing to cooperate with the DEA, Barba was released on $50,000 bond from federal custody in July 2010, according to the report. He was never questioned about the weapons deals he said he facilitated.

The Baytown Crew bought more than 40 firearms over the ensuing six months, including a rifle that turned up on the scene of the deadly assault on Avila and Zapata.

The ATF learned of Barba and his crew through their own investigations, according to the report.
Still, O’Neill cautioned, the agency can’t speculate on how a different turn of events may — or may not have — spared Zapata’s life.

“We don’t believe that it’s possible today to identify what investigative steps should have been taken at the time or precisely when arrests should have occurred,” he said. “The ATF should have been in consultation with the US attorney’s office in Dallas, obtaining advice from the prosecutors there, but our trying to specify what investigative steps should have been taken would just be too speculative, especially since we don’t know what advice a prosecutor would have given the ATF, had the ATF asked.”

The U.S. District Court of the Southern District of Texas indicted Barba, Riendfliesh and rest of the Baytown Crew a week before the attack on Avila and Zapata. ATF agents arrested Barba the following day at his home in Baytown. Riendfliesh was apprehended nine days later in Liberty, Texas.

Barba was sentenced to eight years in prison for drug and firearms offenses. Riendfliesh pleaded guilty to one count of conspiracy and served four years probation.

The Painful truth

PBS Documentary Brings Chronic Pain Out of Shadows

www.painnewsnetwork.org/stories/2017/3/6/pbs-documentary-brings-chronic-pain-out-of-the-shadows

By Pat Anson, Editor

Many chronic pain sufferers are frustrated with how they are depicted in the media – often as lazy, whining, drug seeking addicts.

A new documentary called “The Painful Truth” is trying to change that narrative. It began airing on local PBS stations this month.

LYNN WEBSTER, MD

LYNN WEBSTER, MD

“I wanted to give a voice to people who live in the shadows.  People in pain are often ignored and treated as outcast or druggies,” says co-producer Lynn Webster, MD, one of the world’s leading experts on pain management and past President of the American Academy of Pain Medicine.

“The film tries to demonstrate the lack of humanity that exists today towards people in pain. It also reveals some of flaws in our public policy that has contributed to the current pain and addiction crisis. I hope that the film will be a seed for a cultural transformation in attitudes and respect for the most hurting among us.”

The 30-minute documentary is the video version of Webster’s 2015 award-winning book, The Painful Truth, in which he shares the personal stories of chronic pain patients he treated for over 30 years in the Salt Lake City, Utah area. 

Webster may be retired now as a practicing physician, but he’s determined to have pain sufferers treated with more compassion and respect, not only by the media, but by government, regulators, insurers and their own doctors.

“I’ve had patients who begged me for alternatives to opioids when their insurance wouldn’t cover anything else that would give them relief,” says Webster. “I’ve had patients who could not find a respite from their pain and chose to end their suffering by taking their own life. I’ve cried with, and comforted, the caregivers of my patients, people who are on the front lines every single day doing everything they can to help their loved ones regain the life they once knew.”

Webster and co-producer Craig Worth traveled over 70,000 miles gathering stories from patients and documenting their daily struggles. They also interviewed caretakers, doctors, patient advocates, addiction specialists and law enforcement officials.

The Painful Truth has already aired on KENW-TV in Portales, New Mexico and WXXI-TV in Rochester, New York. It will be broadcast later this week on WOSU-TV in Columbus, Ohio. For a listing of stations and air dates, click here.  

Webster is encouraging pain sufferers to reach out to their local PBS stations and ask them to broadcast The Painful Truth. He says when documentaries air on local public television, it is common for the host station to include a panel discussion with community members.

“If your local public station decides to air this documentary and you would be willing to make yourself available for a panel discussion, I would encourage you to reach out to your station to offer your participation. It could be a great opportunity to discuss how important it is to transform the way pain is perceived, judge and treated,” Webster says.

“I am realistic about the film. It won’t be the solution, but it may open some eyes and more importantly some hearts that could result in better pain care in America.”