A new “opiate crisis”… causing more people to suffer and die ?

Injectable opioid shortages put hospitals on brink of public health crisis

www.whyy.org/articles/injectable-opioid-shortages-put-hospitals-on-brink-of-public-health-crisis/

As the director of pharmacy at Penn Presbyterian Medical Center, Neshaminy Kasbekar used to place orders for injectable opioids a couple of times a week so that the staff would have a week’s supply on hand at any one point.

Now, she’s placing orders every day.

“I’m scrambling right now,” she said.

The hospital is getting 30 percent less injectable morphine, fentanyl, and Dilaudid than it did a year ago.

That’s when a Pfizer manufacturing plant in Kansas cut back production due to quality issues and plant upgrades. Pfizer produces 60 percent of the country’s injectable opioids.

As they wait for supplies to stabilize, Kasbekar and her staff have gotten creative. They’ve purchased injectables in higher concentrations and bigger vials, using those to make smaller measures that they then send to the floors.

They are also rationing injectable opioids for all but the sickest patients — those who are in intensive care or who are undergoing surgery. For the rest, Kasbekar and her staff are encouraging the use of other medications, including oral painkillers or higher doses of over-the-counter remedies such as Tylenol or nonsteroidal anti-inflammatory drugs.

Some smaller hospitals have had to discontinue certain elective procedures because they couldn’t provide injectable painkillers for the patients. That hasn’t happened at Penn, Kasbekar said, but it is more difficult to get what’s needed.

“We’re not at a point where we’ve completely run out, and we’re in trouble,” she said. “But we are concerned that it’s coming — three, four months from now.”

Other hospitals in the region, including Temple, have also experienced shortages; like Penn, they are finding ways to maintain patient care. But getting an adequate supply from other manufacturers — including Akorn, Fresenius Kabi USA, and Hikma (formerly West-Ward Pharmaceuticals) — has been a challenge because those companies don’t have the capacity to fill the void Pfizer has left.

“We’re making progress in mitigating the shortages,” said Matthew Kuhn, a spokesman for Fresenius Kabi, “but given the high demand and limited supply of these specialized drugs, we expect availability of injectable opioids to be constrained and shortages to persist for months.”

In a statement on its web site, Hikma points to controlled substance quotas by the Drug Enforcement Administration for limiting its ability to increase supply.

In the meantime, Kazbekar and her staff continue to meet daily, sometimes twice a day. Given how fast everything is moving, she worries about the possibility of someone making a deadly mistake.

“We’re changing out product on the floors, we have concentrations that are changing, and so, as a result, it could potentially lead to medication errors,” she said. “So we’re really trying to be thoughtful in how we’re doing this, and the manufacturers aren’t really leaving much room for that.”

Pfizer recently sent hospitals a memo explaining how to filter injectable medications that had been held back due to potential particle contamination. The company doesn’t expect supplies to return to normal levels until the first quarter of 2019.

Databases key to Trump’s crackdown on opioids

Databases key to Trump’s crackdown on opioids

The databases are helping to reduce opioid prescriptions, which have fallen by nearly a third since 2011.

https://www.politico.com/story/2018/06/29/databases-key-crackdown-on-opioids-686879

Bolstered by harsh law-and-order rhetoric from President Donald Trump and his aides, police around the country are using electronic databases to unleash a vast crackdown on opioid abusers and the allegedly crooked doctors who sustain them.

The databases are helping to reduce opioid prescriptions, which have fallen by nearly a third since 2011. Police and disciplinary boards use the records systems to roll up “pill mills,” tag patients who “doctor shop” for multiple pills, and warn doctors about prescribing patterns that stray from norms.

Analysis of that data was instrumental in what Attorney General Jeff Sessions described Thursday as the biggest health care fraud crackdown in Justice Department history. Among the 601 individuals indicted were 76 doctors charged with allegedly illegal prescribing or distributing opioids and other narcotics.

Yet it’s unclear the databases do much to help addicted patients. Deaths from illegal opioids like heroin and fentanyl have skyrocketed even as fewer prescription opioids are dispensed — and there’s evidence that thousands of prescription users cut off by fearful doctors are turning to these dangerous street drugs, or being left to suffer. Many addicted patients end up in legal trouble before they are offered help.

Now, civil rights advocates and medical groups are arguing the databases should be used to identify problem patients and get them into treatment. The American Medical Association calls for the databases to be placed under health departments rather than the police agencies and disciplinary boards that control most of them.

The prescription drug monitoring programs “were designed to find those bad doctors — and that kinda shifted at one point to also find those bad patients,” said Corey Davis, a lawyer with the Network for Public Health Law. “It’s in the DNA of them.”

Civil rights activists see such use of the databases as a continuation of a flawed “war on drugs” mentality.

“Law enforcement for easy, warrantless demand [of prescription drug data] keys up a debate as to whether we want to treat this as a public health problem, or a problem we can jail our way out of,” said Nate Wessler, an ACLU lawyer. “Decades of experience shows us it’s impossible to prosecute our way out.”

A powerful tool for law enforcement
Law enforcement’s power to use the databases is truly staggering. In many states, cops can trawl through medical records in search of illicit prescriptions with only slight suspicions of malfeasance.

In 23 state and territory programs, police merely have to be actively investigating a case to check the programs, according to a Brandeis University center that tracks the databases. And doctors often find themselves in the crosshairs.

“There’s really no limits placed on investigators’ ability to access” the information, said lawyer Henry Fenton, who represents a California doctor investigated through that state’s database.

With Trump and Sessions saying some drug pushers deserve the death penalty, advocates say the databases have become tools for intimidation and a boon for investigations by police and professional disciplinary boards.

Law enforcement agencies increasingly use the databases — and aggressively. From 2013 to 2016, the last year for which statistics are available, law enforcement agencies in 42 states conducted well over 2 million searches of the databases, according to a POLITICO review of state-level data. The searches increased more than fourfold in a subset of 18 states from 2011 to 2015.

The tallies probably underestimate database use, as the figures record each time a doctor prescribes a controlled substance. Many state programs automatically ping either law enforcement or state regulatory boards when certain prescription limits are breached.

Given the enormity of the opioid crisis, prosecutors and medical regulators feel they are right to hold clinicians’ feet to the fire.

“Doctors have to be held accountable,” said Michael Morrissey, district attorney of Norfolk County, Mass. “I think it helps to know there are eyes on them.”

In some jurisdictions — like Norfolk County — authorities investigating overdoses have referred cases to professional boards, which can potentially strip a doctor’s license.

Police use of the programs varies widely from state to state. Oklahoma authorities queried that state’s database 10 times more than police in neighboring Texas in 2015, for example. The Oklahoma queries result in criminal charges against 7 to 10 providers a year, said Mark Woodward, spokesman for the state’s Bureau of Narcotics, and investigations of 50 to 100 patients suspected of doctor shopping, forging prescriptions, or street sales.

The programs are effective at providing leads to investigators, initially by pointing out “statistical outliers” — unusual use patterns that may indicate pill mill doctors, said Adam Overstreet, formerly a federal prosecutor in Alabama.

The programs have been so good at detecting pill mills, in fact, that the problem may be subsiding. “I think we’re pretty much beyond” pill mills, said Morrissey. His region’s problems now stem mostly from inattentive doctors and patients who sell their prescribed drugs, he said.

Others think prosecutors are just getting started. “We’re still in the middle of this push,” Overstreet said. “I haven’t seen any signs of it slowing down.”

Policymakers at all levels are exploring further expansion of law enforcement and regulatory board use of the databases. Earlier this year, for example, Sen. Bill Cassidy introduced a bill that would condition HHS grants to prescription drug monitoring programs on their capacity to automatically report suspicions to authorities.

State policymakers have also bolstered police use of the prescription data. Last year, Rhode Island enacted a law allowing designated officers to use the state database without a warrant. The state’s attorney general, Peter Kilmartin, dismissed opposition from local medical and civil liberties groups.

“Maybe the question we should be asking is, ‘What are the doctors trying to hide?’” he said.

In January, Anne Arundel County Executive Steven Schuh called on the Maryland state legislature to make monitoring data more easily available to law enforcement.

Investigators’ targets “are the dregs of the profession, the bottom of the barrel,” Schuh said. Investigators’ use of the Maryland database had already quintupled from 2014 to 2016.

Until this year, the courts had generally ruled that patients had little expectation of privacy and that the Constitution did not require search warrants for use of the databases. That position may be imperiled, however, by late June’s Supreme Court decision in Carpenter vs. United States. The high court ruled in that case that a search warrant was required for authorities to peruse cell phone location data. By analogy, lower-court judges might find that highly sensitive prescription data is similarly sensitive, said the ACLU’s Nate Wessler.

Overstreet disagreed: Pharmaceuticals are already tightly regulated, and people have lower expectations for privacy, he said.

 

Monitoring programs were created for drug enforcement
From their beginning, the drug prescription databases were designed for use by law enforcement and medical and pharmaceutical licensing boards.

California established the forerunner of the drug databases in the 1930s, and other states followed suit with analog prescription-tracking systems: Doctors filled out their scrips on special paper pads that dispensed orders in triplicate. Patients then took the prescription to their pharmacist, who retained one copy and sent another to the database.

More and more programs were established as medicine went digital. Only one state, Missouri, has not established a program — and many of its counties and cities have banded together to create their own patchwork system.

In theory, the programs have treatment, as well as policing, applications: Doctors and pharmacists can use the programs to identify patients taking too many painkillers, and to guide treatment. But access is often an arduous process for doctors, who frequently must exit their digital health records and log into the program separately.

Even after clinicians get into the programs, they often don’t know how to interpret the results. The data don’t come with advice on how to treat patients with a substance use problem, or the availability of clinicians who can handle their problems.

The programs “were never designed for clinicians to check them,” said Davis, the public health lawyer, who has researched their history. Meanwhile, it is “trivial” for law enforcement to pull them up, he said.

For at least some health care workers, evidence that a patient has a problem with a controlled substance means that it’s time to call the authorities. A focus group study of Wisconsin pharmacists published in January found that they were inclined to solve problems by involving the authorities, whether out of fear or conviction.

“You basically have to call 911,” said one focus group participant. “This is not the time and place to be discussing their treatment options. It is the time to get them to jail.”

Clinicians have long complained that the threat of official sanction may dissuade doctors from prescribing some medically legitimate opioids. Patients are complex, they argue; some may tolerate and require high doses of opioids without abusing the drugs. But it’s a brave doctor who can stand up to the prospect of official sanction.

In a December newsletter, the outgoing president of the New York state medical society described the chilling effect of recent warning letters sent by the state bureau of narcotics enforcement.

“Many physicians receiving these letters expressed concern that they felt at risk for … prosecution despite treating their patients in a way they believed was medically appropriate to the patient’s condition,” wrote Charles Rothberg, the president. Officials denied that intimidation was their goal, he said.

The threat of investigations may bring unintended consequences, says critics. If doctors don’t deliver pain medication to patients who need it, the patients may seek out illicit drugs like heroin and fentanyl. The degree to which this already is happening is a matter of debate.

While the mortality rate from prescription drug overdoses is falling, heroin and fentanyl deaths are still rising. A recent review in Annals of Internal Medicine found some evidence that such overdoses increased after the implementation of a prescription drug monitoring program, and said evidence the programs reduce opioid overdoses wasn’t convincing.

Law enforcement vociferously denies any chilling effect on legitimate prescriptions for pain patients.

“Doctors who are practicing good medicine, they’re doing everything they need to do … they’re keeping good records, they’re monitoring for signs of diversion, even if they do have a high number [of prescriptions], they’ll still be safe,” said Overstreet.

Enforcement growing
Prosecutor Morrissey, in Massachusetts, says that state troopers query the prescription drug monitoring program every time there’s a death to find out which doctor last prescribed opioids to the deceased person, and refer the information to the state licensing board.

“Doctors play an important role — they have to be held accountable,” he said. Two or three doctors have turned in their licenses rather than face the board’s scrutiny, he said. Morrissey concluded that the doctors were “a soft touch … If they can’t live up to the scrutiny of their peers, shame on them.”

Clinicians in his state don’t see things that way. “I’m not sure I’d like my first corrective action to be the board of registration,” said Cheryl Bartlett, CEO of New Bedford Community Health Center. Bartlett, a former state public health commissioner, tried to talk Morrissey out his notification plan.

The approach puts prescribers on the defensive, she argued. A better way to change behavior is to offer educational services, she said.

The Department of Veterans Affairs, for example, provides training to all providers regarding best prescribing practices. While “the national conversation is going to death penalties and things like that,” Bartlett said, “most people don’t do well with the Big Brother approach.”

West Virginia has taken a different approach from Massachusetts. In 2017, the state’s public health department conducted a “social autopsy,” tracing each overdose death in the state to its roots. Some physicians associated with several deaths were turned over to the oversight board, said the state health commissioner, Rahul Gupta. But the data was also used to educate state lawmakers, who responded with bills to set opioid prescription limits.

Who administers the databases determines how they’re used. In West Virginia, the prescription monitoring program is run by the board of pharmacy. In other states, law enforcement agencies, licensing boards and public health departments are in charge. Gupta embedded a state health department employee in the board of pharmacy; a law enforcement or regulator might not have the same expertise, he said.

But control by law enforcement agencies is increasingly the norm.

In an April speech announcing an agreement between the Justice Department and 48 attorneys general to share prescription drug program data, Sessions said, “We are going to keep arming you with the tools that you need to keep drugs out of this community. And we are going to keep up the pace.”

 

Indiana lawmaker plans to sponsor bill in upcoming session to legalize medical marijuana in state

https://www.theindychannel.com/news/local-news/indianapolis/indiana-lawmaker-plans-to-sponsor-bill-in-upcoming-session-to-legalize-medical-marijuana-in-state

INDIANAPOLIS — One Indiana lawmaker says medical marijuana could be legal in the state as early as next year. If you’re a beginner, why not find out more here to explore more about how marijuana feels when it enters your system!

Republican State Representative Jim Lucas is sponsoring a bill in the upcoming session and says medical marijuana can help those who are in pain as well as people who are addicted to opioids.

“Now with Oklahoma being the 30th state of the 29 states that have adopted medical cannabis. Thanks to the investors like Andrew Defrancesco–  They’ve seen on an average 25 percent decrease in opioid deaths. Some states have seen a 50 percent decrease. Indiana having 100 opioid deaths per month. That is literally hundreds of lives we can save in the first year,” Lucas said.

Some believe that marijuana users are just seeking a high and there is no medicinal value.

“That’s an insult to each and every Hoosier patient that so desperately needs this. That’s an insult to the 30 states that have legalized this medication plus Washington, D.C. Those leaders are implementing this for a reason. Let’s not insult those leaders. Let’s assume they know something that our leaders don’t know,” David Phipps, National Organization for the Reform of Marijuana Laws, said.

READ ALSO | How Indiana feels about legalizing marijuana | Marijuana in Indiana: Battle lines drawn for the 2018 legislative session

54-year-old Sylvia Kemp takes 23 pills a day. She suffers from multiple sclerosis, spasms, neuropathy, and depression.

She learned the benefits of medical cannabis while on vacation in Colorado. Kemp doesn’t understand the reluctance to legalize it in Indiana.

“Why do I need to be in pain because they don’t understand the benefits? It needs to happen so people can live without pain. With many diseases, not just mine. Although mine is pretty bad, so I would be very grateful,” Kemp said.

She has her fingers crossed that Representative Lucas and the legislators come through this upcoming legislative session.

Lawmakers will convene a summer study committee to examine the issue. Those hearing dates have not been set.

 

Only in America … the land of stupid bureaucrats ?

U.S. charges hundreds in healthcare fraud, opioid crackdown

https://www.reuters.com/article/us-usa-justice-healthcare/u-s-charges-hundreds-in-healthcare-fraud-opioid-crackdown-idUSKBN1JO26B

The U.S. Justice Department on Thursday announced charges against 601 people including doctors for taking part in healthcare frauds that resulted in over $2 billion in losses and contributed to the nation’s opioid epidemic in some cases.

U.S. Attorney General Jeff Sessions addresses a news conference to announce a nation-wide health care fraud and opioid enforcement action, at the Justice Department in Washington, U.S. June 28, 2018. REUTERS/Jonathan Ernst

The arrests came in dozens of unrelated prosecutions the Justice Department announced together as part of an annual healthcare fraud takedown.

The hundreds of suspects charged included 162 doctors and other suspects charged for their roles in prescribing and distributing addictive opioid painkillers.

U.S. Attorney General Jeff Sessions arrives for a news conference to announce a nation-wide health care fraud and opioid enforcement action, at the Justice Department in Washington, U.S. June 28, 2018. REUTERS/Jonathan Ernst

Though many of the cases also involved a variety of schemes to fraudulently bill government healthcare programs, officials sought in the latest crackdown to emphasize their efforts to combat the nation’s opioid epidemic.

According to the U.S. Centers for Disease Control and Prevention, the epidemic caused more than 42,000 deaths from opioid overdoses in the United States in 2016.

While the Justice Department has been conducting investigations into some opioid manufacturers like OxyContin maker Purdue Pharma LP, the cases stemming from the sweep did not focus on wrongdoing by major corporations.

Many of the criminal cases announced on Thursday involved charges against medical professionals who authorities said had contributed to the country’s opioid epidemic by participating in the unlawful distribution of prescription painkillers.

Those charged included a Florida anesthesiologist accused of running a “pill mill;” a Pennsylvania doctor alleged to have billed an insurer for illegally prescribed opioids; and a Texas pharmacy chain owner and two other people accused of improperly filling orders for opioids that were sold to drug couriers.

The Justice Department also announced other cases unrelated to opioids, including schemes to bill the government healthcare programs Medicare, Medicaid and Tricare as well as private insurers for medically unnecessary prescription drugs and compounded medications.

Recently Medicare announced that they are going to increase what they pay for Epidural Spinal Injections (ESI) to encourage pain docs to use these ESI more than prescribing opiates.  There is an estimated 10 million ESI procedures done very year in this country and studies suggests that 5% of those procedures will cause the pt to have Arachnoiditis     a IRREVERSIBLE/INCURABLE painful condition… causing the pt to become a intractable chronic pain pt.   The medication often used is Methylprednisolone… that neither the founder of the medication ( UpJohn) nor the FDA recommends that this medication being used in ESI.

So if this increase in what Medicare pays for this procedures works – instead of following the FDA’s recommendation to NOT USE IT… will cause in excess of 500,000 new intractable chronic pain pts… while at the same time… our bureaucracy is attempting to cause fewer opiate prescriptions to be prescribed/dispensed.

OR force these pts to partake in non-opiate therapies that most insurance don’t pay for and pts can’t afford, don’t have the time or be able to have transportation to participate in all of these non-opiate therapies … not to mention that they don’t work for a lot of pts.

Is this the way a bureaucracy is suppose to work ?… one part causes a problem and another part try to solve the problem that the other part is causing. Of course, we know how successful our bureaucracy has been fighting the war on drugs over the last nearly 50 yrs…  what could go wrong ?

who said that we have the BEST HEALTHCARE SYSTEM IN THE WORLD ?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

This is a pt with MS and has contracted SHINGLES…  who said that we have the BEST HEALTHCARE SYSTEM IN THE WORLD ?

My DOG gets better care from her VET.. than it would seem to be provided this pt.. Don’t know where this pt is and/or what “hospital” she is in…  Doesn’t sound like one I would want to be in “sick” and be expecting to receive appropriate treatment.

U.S. fines CVS for failing to report opioid theft in New York

U.S. fines CVS for failing to report opioid theft in New York

http://kfgo.com/news/articles/2018/jun/28/us-fines-cvs-for-failing-to-report-opioid-theft-in-new-york/

NEW YORK (Reuters) – CVS Health Corp agreed to pay a $1.5 million civil fine to resolve U.S. charges that some of its pharmacies in Nassau and Suffolk counties in New York failed to report in a timely manner the loss or theft of prescription drugs, including the opioid hydrocodone.

Richard Donoghue, the U.S. Attorney for the Eastern District of New York, on Thursday said delays contribute to opioid abuse, and that CVS’ failures impeded the ability of Drug Enforcement Administration agents to investigate, violating federal law.

CVS, based in Woonsocket, Rhode Island, did not immediately respond to a request for comment.

“This settlement is significant because it shows that big chain pharmacies, like CVS, are taking responsibility for violating federal law, which is a step in the right direction for curbing the opioid epidemic,” DEA Special Agent-in-Charge James Hunt said in a statement.

Opioids, including prescription painkillers and heroin, played a role in a record 42,249 U.S. deaths in 2016, according to the U.S. Centers for Disease Control and Prevention.

CVS has more than 130 pharmacies in Nassau and Suffolk, according to its website.

The company reached a $5 million settlement with the U.S. government last July over similar claims involving pharmacies in California.

 

Court overturns Medical Board ruling on Dr. Mark Ibsen

Court overturns Medical Board ruling on Dr. Mark Ibsen

ibsenfinalorder

Florida’s New Law on Controlled Substance Prescribing

Provisions go into effect on July 1, 2018. Here is what you need to know

https://flmedical.org/Florida/Florida_Public/Docs/FMA-Opioid-HB21.pdf

 

An Open Letter to Dr. Andrew Kolodny

An Open Letter to Dr. Andrew Kolodny

https://ramblingsoapbox.com/2018/06/26/an-open-letter-to-dr-andrew-kolodny/amp/

Update 6/27/18: I am overwhelmed by the positive responses I have received for this letter. I would ask that readers also take a look at all the articles and references cited in this piece, and share those as well. Those references go into much, much more detail and research than I have had space or time for here. Thank you all so much for reading and sharing, I believe we will make a difference and win this fight for our lives! #wearehere

See also: A Rock and a Hard Place, The Truth About the Opioid Crisis, and Strangulation on Medicine

Dear Dr. Kolodny,

I am one of millions of chronic pain patients in the United States who has been continually and increasingly oppressed over the past few years by progressively invasive and prohibitive laws at the state and federal levels concerning the delicate relationship between doctors and patients, particularly when it comes to a certain class of drugs, i.e. opiates.

Ever since my very real, physical condition began about 4 years ago, my family and I have been disoriented again and again by a lack of what might be termed, “help,” from doctors. We have discovered a very confused medical community, corruption, and a growing collection of laws being passed so fast and furiously hardly anyone seems to know just what is going on.

This has resulted in doctors leaving my city, doctors outright refusing to accept chronic pain patients (or, if they do accept these patients, refusing to treat them with medications that suit the patient best) or new patients, and unprecedented referrals to pain management clinics and psychiatrists. I have a detailed post planned addressing the pain management clinics, but the psychiatrist referrals were more baffling to me. My local psychiatrists even refused me as a patient about a year ago because, “we don’t see chronic pain patients.” That made sense to me as I don’t suffer from mental illness, still my providers insisted I must be mistaken.


Down the Rabbit Hole

I began researching you and your career last night out of curiosity. I wanted to answer the question, “Who is this Dr. A. Kolodny, that everyone from journalists to policy makers and bloggers keep quoting as an “expert on opiates”?” And I found out. You, sir, are a psychiatrist and board-certified addiction specialist-turned policy maker (1) and buprenorphine (Suboxone) “evangelist” (2).

Your first private clinic was a Suboxone clinic in New York City, established sometime around 2003-2005, and it appears you (and/or other health officials) felt stymied by the federal limit at the time of just 30 patients for such clinics (put in place to stem corruption), because said health officials have been in the background, quietly working away at this very limit which was amended in 2006 (called DATA), to allow 100* patients after 1 year, and is now up in the House for being overturned altogether, along with expanding legal prescribers to nurses and other non-doctor medical staff. And look what has happened as a result:

Health officials, concerned about restricted access, lobbied alongside Reckitt Benckiser for the patient cap to be raised. “Why should we bind a healer’s hands from helping as many as he or she could?” Senator Hatch said, getting an amendment passed in 2006 that allowed doctors, on request, to go from 30 to 100 patients after a year.

The stage was set for more patients, prescriptions and problems. “It’s when the limit was raised from 30 that doctors started to get commercial about it,” said Dr. Art Van Zee, whose buprenorphine program at a federally funded community health center in rural Virginia is surrounded by for-profit clinics where doctors charge $100 for weekly visits, pulling in, he estimated, about $500,000 a year.

“They are not savvy about addiction medicine, don’t follow patients very closely, don’t do urine testing and overprescribe,” he said. “That’s how buprenorphine became a street drug in our area.” https://www.nytimes.com/2013/11/17/health/in-demand-in-clinics-and-on-the-street-bupe-can-be-savior-or-menace.html (4)

“In the early days of Suboxone, with Reckitt Benckiser barely marketing its own drug, Dr. Kolodny, then a New York City health official, crisscrossed the city with colleagues to spread the word about the new medication, entice public hospitals to try it with $10,000 rewards and urge doctors to get certified.”

https://www.nytimes.com/2013/11/17/health/in-demand-in-clinics-and-on-the-street-bupe-can-be-savior-or-menace.html (4)

Since at least 2005, you have been marketing buprenorphine as if you had a personal stake in the drug, to government institutions and agencies including prisons, public hospitals, and rehabilitation facilities (2). In the fall of 2013, you were appointed Chief Medical Officer (5), of the largest chain of non-profit detox/rehab facilities in the USA (cited for questionable practices and abuse from at least 2012-2015) (6) called Phoenix House, which received $131 million in June 2013 (7), championing the use of MAT, or “Medication Assisted Treatment”. I wonder which drug Phoenix House used?


Hang ‘Em High?

salem witch hanging.PNG
An innocent “witch” (woman) is hanged at the Salem Witch Trials, much like other innocent pain patients are persecuted.

Since you often cite the United States vs. Purdue Pharma (2007) settlement in your interviews and writings, perhaps you saw an opportunity to expand the use of buprenorphine by targeting and demeaning chronic pain patients as mere “addicts”.
It was odd to me in researching that incident, in the official “Purdue Guilty Plea” document (8), the very words they were condemned for, claiming OxyContin to be “less addictive” and “less subject to abuse and diversion” (8), appear to be the exact words you use time and again when describing the benefits of buprenorphine (2).

Kolodny reminds his colleagues of the drug’s advantages. He stresses that bupe in the form of Suboxone is safe and almost impossible to abuse, a huge selling point at many of the clinics they will visit. Suboxone has a second active ingredient in the mix, he explains, an anti-overdose drug called naloxone.

It does nothing if you take bupe as directed. But if you sniff bupe or inject it or otherwise try to pack enough into your bloodstream to get high, the naloxone acts like a chemical booby trap, erasing the effects of any opiate, bupe included, and bringing on sweaty, nauseating withdrawal. “That’s the last time you’ll do it,” Kolodny says dryly. https://www.wired.com/2005/04/bupe/

In 2016, your organization, PROP (Physicians for Responsible Opiot Prescribing), got the ear of the CDC and helped to write the now-infamous, misinformed, and rushed guidelines for prescribing opiates. While these guidelines were fairly general in nature, they have been used as a springboard for countless pieces of state legislation and DEA investigations, which has, in turn, led to the above-mentioned abuse and abandonment of chronic pain patients and doctors, as well as opiate shortages in hospitals and ERs (The DEA, in an attempt to prevent diversion of opiates to the black market, has cut production by an incredible 45% in the past 2 years). I imagine that suits you just fine, since you have publicly stated you believe opiates should be discontinued for all but the dying and post-major surgery “for a few days” (https://www.ket.org/opioids/inside-opioid-addiction-10-questions-with-dr-andrew-kolodny/), and that “more treatment” is needed (https://www.vox.com/science-and-health/2017/8/3/16079772/opioid-epidemic-drug-overdoses), i.e. MAT/Suboxone clinics like Phoenix House.

'The National Gesture' 1926
“The National Gesture” 1926

You have hailed local municipalities and states in their further pursuit of legal action against American Big Pharma, the companies who make such things as Vicodin and Percocet, but not Suboxone/buprenorphine (which is also an opiate), which is made by an overseas company, Reckitt Benckiser, or Naloxone (Narcan), which is produced in a nasal spray exclusively by Amphastar Pharmaceuticals (10), a relatively new company founded in California in 1996 (11),  whose stock (and Narcan prices) has been rising quite a bit, lately (12, 13). Are you truly against the use of opioids, or just the ones that help pain?


The Opioid Epidemic!

mccarthyism
McCarthyism Propaganda

Although your policies, based on inaccurate data (14-15) https://www.acsh.org/news/2017/10/12/opioid-epidemic-6-charts-designed-deceive-you-11935 (15), and http://www.mdmag.com/journals/pain-management/2012/october-november-2012/just-how-responsible-is-prop, have been wildly ineffective at stopping heroin/fentanyl overdoses; although you are not a pharmacologist, opiate researcher, pain doctor, pain patient, surgeon, or even general practitioner; although you ran a private clinic for a short time in 2005 (as far as I’ve been able to learn) that dispensed buprenorphine/Suboxone, you have, for the majority of your career as far as I can tell, been a policy-maker and not directly involved with addiction patients or chronic pain patients whom you recently claimed were simply addicts who needed compassion and “treatment” (and, presumably, Suboxone).

“Many Americans are truly convinced that opioids are helping them. They can’t get out of the bed without them.”

“Policy makers were told by industry-funded pain organizations not to penalize pain patients because of drug abusers. We realized that this wasn’t true. We don’t have these two distinct groups, one for pain patients and the other for drug abusers.” https://www.kolmac.com/2015/12/qa-dr-andrew-kolodny-chief-medical-officer-phoenix-house/ (15a)


If You’re Not For Us, You’re Against Us

sen. joe mccarthy demonstrates the communist threat
Senator Joe McCarthy Demonstrates the Communist Threat in America

You are cited and quoted in an impressive number of articles and interviews as a compassionate person who wants to see people and their families heal from the devastation of addiction, which is why it surprised me to find quotes from you that didn’t seem, well, “nice.”

It is the FDA’s role to vigilantly regulate the approval, labeling, and promotion of  pharmaceutical products, not that of counties or municipalities. County and municipal lawyers are inadequately qualified to make or enforce federal drug policy, and these lawsuits serve as a vehicle for local governments to seek revenue  through ill-informed measures under the guise of drug abuse prevention. In a May 30,2014, interview with   FDA Week, a CLAAD spokesman voiced these positions and expressed concern that these lawsuits are part of “a trend that will distract us from the real meaningful approaches to reducing prescription drug abuse.”

After reading the interview, Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing (PROP)and Chief Medical Officer of Phoenix House,  contacted CLAAD via telephone to condemn its comments. During this conversation, Kolodny threatened that the Internal Revenue Service would revoke CLAAD’s tax-exempt status when alerted to the comments, which he believes conflict with CLAAD’s charitable mission.  CLAAD takes these false allegations and threats very seriously, and  responded in a letter which is publicly available for view on our website.

Critics who categorically dispute the motives of organizations like CLAAD and its diverse coalition members are, at best, narrowly focused. Their zealotry reveals their otherwise undisclosed health insurance industry bias.  At worst, they endanger the lives of people who live with pain and other conditions that can require controlled substances by stifling access to quality care. http://paindr.com/claad-and-phoenix-house-square-off/ (16)

Anyone who questions your authority, expertise, policies, or the efficacy of your pet drug, buprenorphine, is loudly dismissed by you as uneducated (17), addicted (15a), or corrupt (15a, 18), regardless of how closely they actually work with addicts and pain patients (17).

But Dr. Kolodny, I have nothing left to lose — your policies and attitudes have directly impacted my health, my freedom, my ability to be a parent, my work, my hobbies, my family, my finances, my friends, and my personhood. I have no problem announcing to the public, as loudly as I can, “The Emperor is not wearing any clothes!”

emporer has no clothes


Citations

(1) http://www.cecentral.com/search/faculty/136145

(2) https://www.wired.com/2005/04/bupe/

(5) https://www.phoenixhouse.org/news-and-views/news-and-events/phoenix-house-appoints-dr-andrew-kolodny-as-chief-medical-officer/

(4) https://www.nytimes.com/2013/11/17/health/in-demand-in-clinics-and-on-the-street-bupe-can-be-savior-or-menace.html

(6) https://www.reuters.com/investigates/special-report/usa-rehab-phoenixhouse/

(7) http://www.phoenixhouse.org/wp-content/uploads/2014/06/2013-Financial-Report.pdf

(8) https://assets.documentcloud.org/documents/4378824/Purdue-Guilty-Plea-Copy.pdf

(9)

(10) https://www.npr.org/sections/health-shots/2015/09/10/439219409/naloxone-price-soars-key-weapon-against-heroin-overdoses

(11) http://www.amphastar.com/about-us.html

(12) https://www.equities.com/news/naloxone-stocks-who-s-really-winning-the-battle-against-the-opioid-epidemic

(13) https://thinkprogress.org/pharmaceutical-company-with-monopoly-on-lifesaving-treatment-jacks-up-prices-3883e95f88c7/

(14) https://medium.com/@stmartin/neat-plausible-and-generally-wrong-a-response-to-the-cdc-recommendations-for-chronic-opioid-use-5c9d9d319f71

https://www.ket.org/opioids/inside-opioid-addiction-10-questions-with-dr-andrew-kolodny/

(15) https://www.acsh.org/news/2017/10/12/opioid-epidemic-6-charts-designed-deceive-you-11935

(15a) https://www.kolmac.com/2015/12/qa-dr-andrew-kolodny-chief-medical-officer-phoenix-house/

https://abcnews.go.com/Health/deaths-drug-overdoses-continue-rise-us-blacks-hispanics/story?id=54094943

(16) http://paindr.com/claad-and-phoenix-house-square-off/

(17) https://www.nytimes.com/2016/05/29/opinion/sunday/addicted-to-a-treatment-for-addiction.html

(18) https://www.kolmac.com/2015/12/qa-dr-andrew-kolodny-chief-medical-officer-phoenix-house/

https://www.vox.com/science-and-health/2017/8/3/16079772/opioid-epidemic-drug-overdoses

https://www.cdc.gov/drugoverdose/prescribing/guideline.html


Further Resources

https://www.cdc.gov/drugoverdose/prescribing/guideline.html

https://www.bendbulletin.com/topics/5342867-151/opioid-crisis-pain-patients-pushed-to-the-brink

http://www.mdmag.com/journals/pain-management/2012/october-november-2012/just-how-responsible-is-prop

http://nationalpainreport.com/cdc-does-not-comply-with-federal-law-8828305.html

https://www.chronicle.com/article/To-Counter-Opioid-Crisis-NIH/240219

https://www.painnewsnetwork.org/stories/2016/8/11/prop-ends-affiliation-with-phoenix-house

https://www.drugabuse.gov/publications/research-reports/relationship-between-prescription-drug-abuse-heroin-use/introduction

What Pharmacists are saying “on the web” about not filling controls..and.. why

 

We have been told directly per company policy and multiple emails that in cases where we refuse to fill controls we are to cite “professional judgment” and are absolutely not supposed to give any more details than that. We wouldn’t want to get sued for being ‘defamatory’ toward a prescriber, of course. This is mainly in situations where we feel the doctor is basically running a pill mill or has other unethical practices though. In general we try to explain dosing issues and the need to call an office when things seem legitimate”


“Was told by ohio board investigator that we cannot be specific with the patient as to why we are refusing. We can only tell them we are not comfortable filling the prescription, and that their doctor can call and discuss with us. He said that when we start explaining why we are refusing to fill it is deemed as “practicing medicine.”


“Our corporate guidelines prohibit us from being specific such as not to cause a customer service issue. Our state has made it a felony to discuss controlled database findings with patients but made it mandatory for both MD and RPh to utilize it…yet here we are. A script that shouldn’t be filled, but I can’t be truthful with the patient as to why…talk about an enthical conundrum…”


“one of the big chains has a refusal policy in place, but you’re not allowed to tell the patient specifically why you’re refusing it, as that would be “disclosing proprietary company information.” This definitely has patients leaving without an understanding of why it’s not being filled. I can’t tell you how much I would love to be able to say “Because your prescriber is a lying sleezeball and I don’t want my name on anything associated with him.”