Scientists Blast FDA, Warn That a Ban on Kratom Would Cause More Opioid Deaths

https://www.blacklistednews.com/article/63664/scientists-blast-fda-warn-that-a-ban-on-kratom-would-cause-more-opioid.html

The United States Food and Drug Administration ramped up its “War on Kratom” this week by labeling the natural herb as an opioid, and a group of scientists is stepping up to vouch for kratom’s safety, and to argue that banning it would only lead to more opioid-related deaths.

In a statement, FDA Commissioner Scott Gottlieb warned that there is “even stronger evidence of kratom compounds’ opioid properties.” He claimed that there is evidence of 36 deaths related to kratom, but that “many of the cases received could not be fully assessed because of limited information provided.”

In response, a group of scientists came together to send a letter to the acting administrator of the Drug Enforcement Administration, Robert Patterson; and the counselor to the president who is overseeing the administration’s response to the opioid crisis, Kellyanne Conway.

The letter strongly criticized the FDA’s recommendation to label kratom as a Schedule I drug, which would mean that the government will claim that it has no medicinal value.

“We believe strongly that the current body of credible research on the actual effects of kratom demonstrates that it is not dangerously addictive, nor is it similar to ‘narcotics like opioids’ with respect to ‘addiction’ and ‘death’ as stated by the FDA in its November 14th Kratom Advisory. Equally important, four surveys indicate that kratom is presently serving as a lifeline away from strong, often dangerous opioids for many of the several million Americans who use kratom. A ban on kratom that would be imposed by CSA Scheduling would put them at risk of relapse to opioid use with the potential consequence of overdose death. Similar unintended consequences are to be expected in some who would be forced to use opioids to manage acute or chronic pain.”

The scientists noted that when kratom is consumed in raw plant form, “it does not appear to produce the highly addictive euphoria or lethal respiratory depressing effects of classical opioids.” In fact, they argued that labeling kratom as a Schedule I drug would actually increase the number of opioid-related deaths in the United States.

“It is our collective judgment that placing kratom into Schedule I will potentially increase the number of deaths of Americans caused by opioids because many people who have found kratom to be their lifeline away from strong opioids will be vulnerable to resumption of that opioid use, whether their prior opioid use was for relief of pain or due to opioid addiction,” the scientists wrote.

The letter cited several national surveys and a wealth of studies from both the U.S. and Asia, which found that “kratom has been used as a safer alternative to opioids for more than a century,” and if the government truly cared about the safety of the consumer, they would refrain from making kratom a Schedule I drug.

Although the FDA is claiming that kratom is responsible for at least 44 deaths, that is nothing when compared to the number of deaths that have occurred from opioid overdoses in recent years. As President Trump noted at his first State of the Union address, “In 2016, we lost 64,000 Americans to drug overdoses: 174 deaths per day. Seven per hour.”

However, the scientists questioned whether the FDA could actually prove that the deaths it cited were related to kratom overdoses. They noted that while opioid overdose deaths result from respiratory depression and death at high doses, the deaths the FDA claims are from kratom overdoses include “a wide variety of apparent causes in people suffering from various diseases and/or taking other substances that also likely contributed to their deaths.”

Why is the FDA pushing to ban kratom when research has shown that not only is it a safer alternative to opioids, but that it actually helps to prevent opioid-overdose deaths?

As The Free Thought Project has reported, by pushing for a ban on kratom, the FDA is ensuring that Big Pharma will have a lifetime of profit, and the commissioner of the FDA is directly responsible:

Before taking over the FDA and using his position to enrich his fellow legal drug dealers, Gottlieb was a member of GlaxoSmithKline’s product investment board. And, as TFTP has previously reported GlaxoSmithKline owns a patent on a kratom alkaloid designed for the very purpose of treating pain, thereby alleviating dependency on opioids. One of Kratom’s alkaloids—Speciofoline—was researched decades ago by Gottlieb’s former employer and its effects have been widely studied and reported on.

It just so happens that a patent was filed for Speciofoline on August 10, 1964. The patent claims the “alkaloid has useful pharmacodynamic activity, particularly analgetic and antitussive activity.” But that’s not all. Other studies—which the FDA says do not exist—have been conducted for the specific task of treating opioid dependency.

Many people take dangerously high amounts of ibuprofen

http://www.foxnews.com/health/2018/02/08/many-people-take-dangerously-high-amounts-ibuprofen.html

 

Many adults who use ibuprofen and other so-called nonsteroidal anti-inflammatory (NSAID) drugs take too much, increasing their risk of serious side effects like internal bleeding and heart attacks, a U.S. study suggests.

About 15 percent of adults taking ibuprofen (Motrin, Advil) or other NSAIDs like aspirin, naproxen (Aleve), celecoxib (Celebrex), meloxicam (Mobic) and diclofenac (Voltaren) exceeded the maximum recommended daily dose for these drugs, the study found.

“NSAIDs are among the most commonly used medicines in the U.S. and worldwide,” said lead study author Dr. David Kaufman of Boston University.

“These drugs can have serious side effects, including gastrointestinal bleeding and heart attacks, and are often taken without medical oversight because many products are available over-the-counter,” Kaufman said by email. “The attitude that users can choose their own dose regardless of label directions, along with poor knowledge of dosing limits, is associated with exceeding the daily limit.”

For the study, 1,326 people who reported taking ibuprofen in the previous month completed online medication diaries every day for one week.

All of the participants took ibuprofen during the diary week, and 87 percent of them only used over-the-counter, or nonprescription, versions, researchers report in Pharmacoepidemiology & Drug Safety.

Overall, 55 percent of participants took ibuprofen at least three days during the week, and 16 percent took it every day.

In addition to ibuprofen, 37 percent of the participants reported taking at least one other NSAID during the week, most often aspirin or naproxen. Less than half of them recognized that all of the products they were taking were NSAIDs.

One limitation of the study is that researchers only focused on recent and current ibuprofen users, which may not reflect what doses might be typical for sporadic or new users, the authors note.

Even so, the findings highlight a potential downside of making NSAIDs widely available without a prescription, said Dr. Gunnar Gislason, director of research for the Danish Heart Foundation in Cophenhagen.

“I believe that the message sent to the consumer when these drugs are widely available in convenience stores and gas stations is that these drugs are safe and you can use them safely for pain relief – thus no need for reading the label,” Gislason, who wasn’t involved in the study, said by email.

Even when people do read the label, they may still ignore it.

“If the recommended dosage does not give sufficient pain relief, it is easier to take more pills than seeking professional advice from a healthcare person or doctor,” Gislason added.

While doctors may prescribe NSAIDs for some muscle and joint disorders and certain other health problems, these drugs aren’t appropriate for many of the reasons that patients may buy them at the drugstore, said Dr. Liffert Vogt of the Academic Medical Center at the University of Amsterdam in the Netherlands.

“In my opinion NSAIDs should not be available as an over-the-counter drug, because of all their deleterious effects,” Vogt, who wasn’t involved in the study, said by email.

“For occasional use, acetaminophen (again in the right dose) is a much safer option and very efficacious as a pain killer,” Vogt added. “But we know that many people use NSAIDs for indications other than pain, such as flu, allergies, fever – and there is no medical base that indicates that NSAIDs or acetaminophen are of any use under these circumstances.”

 

 

Med used to help addicts… is now being abused

Lawsuit: Clinics wrote thousands of fraudulent addiction drug prescriptions

The lawsuit alleges that The Recovery Center and four of its owners defrauded Medicaid by claiming it offered patients medical advice

https://www.ems1.com/addiction/articles/375129048-Lawsuit-Clinics-wrote-thousands-of-fraudulent-addiction-drug-prescriptions/

BREATHITT COUNTY, Ky. — A clinic with locations in Central and Eastern Kentucky improperly prescribed thousands of doses of a drug designed to help treat people addicted to opioids such as heroin and pain pills, Attorney General Andy Beshear’s office charged in a lawsuit filed Friday.

The lawsuit alleges that The Recovery Center, which is based in Breathitt County, and four of its owners defrauded the Medicaid program by falsely claiming it offered patients required medical advice and individual treatment along with prescriptions for Suboxone.

The lawsuit seeks to recover money from The Recovery Center received under the Medicaid program, as well as fines and other financial damages.

Beshear said his office recently raided four clinics operated by the business and that a criminal investigation is underway.

Clinics can qualify for Medicaid payments for providing medication-assisted addiction treatment. Suboxone, which combats cravings for opioid drugs, is widely used in such treatment.

However, clinics are supposed to provide individual treatment that includes steps to reduce a patients’ use of Suboxone over time, Beshear said in a news release.

The Recovery Center was billing Medicaid for spending 15 minutes with each patient, but that was “mathematically impossible” given the number of doctors in its clinics, Beshear said.

For example, the lawsuit alleges that on one day in 2017 at the Recovery Center clinic in Jackson, the owners wrote 136 Suboxone prescriptions, all for the same dosage amount.

The Recovery Center has clinics in Jackson, Hazard, London, Paintsville, Frankfort, Richmond and Mount Sterling, Beshear said.

Beshear called the clinics “pill mills.”

“The owners are strictly operating for profits and couldn’t care less about the health and safety of our families and neighbors who are struggling with addiction,” Beshear said in a news release.

Beshear’s office filed the lawsuit in Breathitt County against the business and the owners — Dr. George Burnette, Jerry Campbell, Justin Neace and Robert Jack Duncan.

No one returned a telephone message left at a number listed for the clinic in Jackson.

The lawsuit charges that The Recovery Center billed Medicaid for services that were not provided or were not needed. It required unnecessary weekly appointments and drug screens, and unneeded prescriptions led to the state “being flooded with thousands of dangerous and addictive doses of Suboxone that were subject to abuse and diversion.”

Beshear said his office has been reviewing a trend in the abuse of Buprenorphine medications — Suboxone is one — by clinics that prescribe them without the necessary counseling and treatment. There is a black market for the drug.

“Now we are seeing a treatment for addiction being the cause of addiction due to the reckless behavior of clinic owners like those who run The Recovery Center,” Beshear said in the release.

I have had a horrific traumatizing experience recently with a #Walgreens pharmacist

Hi Steve! My name is xxxx.xxxxx and my attorney recommended that I reach out to you. I have had a horrific traumatizing experience recently with a Walgreens pharmacist. This went beyond refusal to fill a prescription and the pharmacist actually edited my Walgreens profile as well as flag my prescription. I have been using a different Walgreens consistently for 2+ years and seeing the same doctor who writes these prescriptions for me. However my local Walgreens was out of two of the three medications I desperately needed and recommended I take my prescriptions to a different Walgreens, one that had what I needed in stock. Needless to say this turned into a nightmare, total humiliation and shame and I literally feel like I was criminalized by this pharmacist. Again my situation goes way past refusal to fill a much needed prescription. This particular pharmacist became vindictive and I believe crossed a line most certainly of ethical duty but possibly a legal one. I know this because after spending several hours going back and forth and going to a third Walgreens pharmacy after her refusal , I was treated horribly. I then returned to my pharmacy in tears and pain and my pharmacist was dumbfounded at how I was treated. When she went into the computer to see why my prescription was flagged, she was irate at what she saw. She was not surprised when I told her the other pharmacists name that treated me so badly but she was very surprised to see what she had done to my Walgreens profile. I am angry at myself for not getting the specifics in that moment but as I said earlier it was a long day and I was in so much pain. I do know for a fact that my two pharmacists could not apologize enough about what transpired and could not wrap their heads about this others pharmacists negative actions against me. I believe they said not only did she flag the script as a possible non valid prescription, she proceeded to alter my profile or erase it including the icd-9 or 10 codes that were established. Off the record my pharmacist insisted I speak to corporate and the district manager and file a complaint with the California board of pharmacist. Needless to say that I still have not received all my medications as my Walgreens has been unable to obtain one of the meds and on top of my many pre-existing issues I was involved in a pretty severe riding accident 3 days prior to this experience where I was thrown off a quad going about 30 miles per hour and thrown 3-4feet in the air before landing very hard on hard sand on my left side.needless to say I really damaged my left shoulder and arm and still have little to zero mobility of my left side. I would so appreciate talking with you if possible because i wanted to not send a novel with some of the important details regarding this but wanted to at least send you a summary and hope to get your attention with this so we can then speak further .I am determined if nothing else, to see some serious consequences for this pharmacist and if In fact her actions against me are illegal then I plan on pursuing legal action. Also just another fact in this, I actually work in the field of mental health and substance abuse and have done so for the last 8 years. I was an integral part of developing and launching the first two free standing detoxes in San Diego. I have my own small company and have been self employed for approximately 3 years. I am very well known and respected in this field and because of that this is a very sensitive issue for me. Although all my colleagues know that I am not a person in recovery or have struggled with addiction issues, I try to keep this very private for several reasons .

Our country has a serious – and growing – Pharmacist surplus.. so if any chain is not happy with the attitude or the way one of their employed pharmacist treats pts.. they could replace them in a heart beat… but .. apparently chose not to.  They all claim how much they care about pts… maybe many of their employees have not read that memo..

Here is a link where pts can find local independent pharmacies where you will be dealing with the owner/pharmacist… who use “good customer service” as the reason people keep returning to patronize their pharmacy. http://www.ncpanet.org/home/find-your-local-pharmacy

 

 

OxyContin maker will stop promoting opioids to doctors

https://www.bellinghamherald.com/news/article199479559.html

February 10, 2018 10:34 AM

Updated 2 hours 14 minutes ago

CBD oil reduces child’s seizures by 95% … DCS FLEXES ITS MUSCLE – 4th Amendment violated again ?

Indiana family sues DCS after they allegedly tried to take daughter for CBD treatment

www.fox59.com/2018/02/09/indiana-family-sues-dcs-after-they-allegedly-tried-to-take-daughter-for-cbd-treatment/

EVANSVILLE, Ind. – A southern Indiana family has filed a lawsuit against two Department of Child Services (DCS) workers who allegedly tried to take their daughter away following cannabidiol (CBD) oil treatment for her seizures.

The story started last year, when Jade and Lelah Jerger started using CBD oil instead of the pharmaceutical drug Keppra to treat their daughter’s epilepsy. You can find artisan CBD flower in some parts of the country.

The couple says Jaelah Jerger saw a 95 percent reduction in seizures with the CBD oil. When doctors at Riley Hospital for Children at IU Heath found out she wasn’t using the prescription, the family says the hospital alerted DCS, who paid them a visit and threatened to take their daughter away.

DCS said doctors told them child was neglected and in danger.

“The worst week ever. It was terrifying just knowing that at any point in time they could show up and take our daughter without being valid and I didn’t find it valid and a lot of people in Indiana and across the world don’t find it valid,” said Lelah Jerger.

In the lawsuit, the Jergers claim Jaelah was ordered to have her blood drawn to make sure Keppra was in her system.

“We’ve shown you the bottle. You know that she’s on the Keppra, I mean we’ve already told you, why is our word not good enough?” Jerger questioned.

They claim the drawing was a violation of the fourth amendment and was a warrantless search and seizure.

“Our end goal is to hope that no other family has to go through this again,” said Jerger.

The family is demanding a jury trial.

House passes bills seeking to increase fight against opioids

http://www.bellinghamherald.com/news/article199404419.html

The Washington House passed measures Friday that require drug manufacturers and doctors to do more to fight opioid abuse, part of an effort to save the lives of hundreds of state residents who die as result of overdose every year.

House Bill 1047 was passed by an 86-12 vote, while House Bill 2489 received unanimous approval. Both measures now move to the Senate for consideration.

The first bill requires:

pharmaceutical companies to pay for the disposal of unwanted medication by consumers.

The latter bill requires doctors to obtain additional training before they can prescribe opioids and hold in-person discussions about risks and alternatives with patients receiving the treatment for the first time.

It also authorizes pharmacists to partially fill prescriptions and connects counselors with those who have had non-fatal overdoses.

Almost 1,100 Washington residents died in 2015 from drug poisoning

a 12 percent increase from a year-earlier, according to Centers for Disease Control and Prevention data . That’s more than the number of deaths due to firearms and homicide combined. Washington Gov. Jay Inslee proposed last month allocating $20 million to treatment and prevention programs to fight opioid addiction. The House and Senate are set to unveil their budget proposals in coming months.

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“This bill will help save lives, and give doctors, law enforcement and first responders more tools to fight this crisis,” Inslee said in a statement after approval of House Bill 2489. “It will provide help for people who need treatment, and offer wrap around services like housing and employment supports they need to stay healthy and get back on their feet.”

Requiring drug manufacturers to take back unwanted medication from consumers has already been implemented at the local level in some of the state’s biggest counties, including King and Snohomish, according to a summary of House Bill 1047. Massachusetts, Vermont and California have also adopted similar pharmaceutical product stewardship laws, it said.

Some lawmakers opposed requiring drug companies to fund repossession and disposal on concerns that they would raise prices. Others charged that the measure mandating additional opioid training for doctors is unnecessary, given that they’re already heavily trained and regulated, and because it doesn’t do enough to address heroin addiction.

“We’re fighting the wrong monster here,” said Republican Rep. Dan Griffey. “It’s now heroin. It really is.”

In September Washington state and the city of Seattle joined more than two dozen other government entities across the country suing to hold opioid makers accountable for the addiction crisis.

The governments hope to recoup costs of responding to drug addiction, including money spent on emergencies, criminal justice and social services.

The Washington state lawsuit accused the drug companies of deliberately overstating the effectiveness of their prescription painkillers while misleading patients and doctors about the risks of addiction — in violation of Washington’s consumer protection laws.

Purdue Pharma, the maker of OxyContin and one of the companies named in the legal action, has denied those allegations but said in a statement at the time that it was “deeply troubled” by the addiction crisis and “dedicated to being part of the solution.”

This bill apparently gives Pharmacists the LEGAL RIGHT to change the quantity on a opiate prescription. – a basic function of the practice of medicine.. so is the state of Washington legislature giving pharmacist the legal right to practice medicine without making a change to either the Medicare practice act nor the pharmacy practice act.

Using national averages.. the state of Washington would have about 12,500 deaths from the use/abuse of the two drugs Alcohol & Nicotine… about TEN TIMES what die of opiate overdoses.

Why are we not seeing legislatures being concerned about all these deaths ?

Local Kratom users disagree with new FDA warnings

 

http://13wham.com/news/local/local-kratom-users-disagree-with-new-fda-warnings

 

ROCHESTER — The FDA released findings on Tuesday that suggest an herbal supplement promoted as an alternative pain remedy contains the same chemicals found in opioids.

Kratom is drawn from a plant and has become increasingly popular for recovering opioid addicts looking to ween themselves off of painkillers.

Rob Brockler, owner of the Kratom Shop on Monroe Avenue, says it helped him break his drug habit so much that he opened the shop in December to help others.

“It’s a unique plant that deserves to remain legal,” Brockler said.

FDA scientists revealed that the 25 most common chemicals in Kratom behave like compounds found in opioids.

Kratom is banned in at least five states in the United States.

“It was green Kratom that I started with,” said Emily Szarak, a user of the supplement. “That has been a lifesaver. I feel like a human again.”

Szarak told 13WHAM that she is trying to have a baby and turned to Kratom after years of taking prescription pills to treat chronic pain.

“With the physical pains of getting off of medications, [Kratom] helps tremendously with that,” Szarak said. “Your bones ache sometimes. Kratom helps with that.”

Brendon Kuchinick, of Victor, has spent eight months out of rehab.

“After rehab, I took half a spoonful of Kratom,” Kuchinick said. “I felt motivated to do things that I slept the entire night.”

Kratom is legal under federal law but after the FDA’s findings, the DEA will now have to decide if Kratom should be in the same category as heroin and LSD.

Retired Monroe County Forensic Scientist Jim Wesley says he’d like to see more data before any decisions are made.

“I think as a minimum, you should be 21 years or over to buy it,” Wesley said. “I would like to see some information on how its used. I think right now, it is really up in the air.

The FDA says its identified 44 reports of death involving Kratom since 2011. Critics say the research is flawed, noting that some of those victims mix Kratom with other drugs.

 

Trump Says He Will Focus On Opioid Law Enforcement, Not Treatment

https://www.npr.org/sections/health-shots/2018/02/07/584059938/trump-says-he-will-focus-on-opioid-law-enforcement-not-treatment

More than three months after President Trump declared the nation’s opioid crisis a public health emergency, activists and health care providers say they’re still waiting for some other action.

The Trump administration quietly renewed the declaration recently. But it has given no signs it’s developing a comprehensive strategy to address an epidemic that claims more than 115 lives every day. The president now says that to combat opioids, he’s focused on enforcement, not treatment.

Trump spent just over a minute of his 80-minute State of the Union address talking about opioids. In a speech this week in Cincinnati, he had a few more comments. The opioid epidemic, he said, “has never been worse. People form blue ribbon committees. They do everything they can. And frankly, I have a different take on it. My take is you have to get really, really tough, really mean with the drug pushers and the drug dealers.”

The president’s mention of “blue ribbon committees” sounds like a slam on one he convened last year, chaired by former New Jersey Gov. Chris Christie — the President’s Commission on Combating Drug Addiction and the Opioid Crisis. The commission issued more than 50 recommendations. The administration has so far followed up on just a few of those recommendations.

Some officials and care providers who work on the frontlines of the opioid crisis, however, are scathing about what they see as a lack of action from the White House. Former Congressman Patrick Kennedy, who served on the White House opioid commission, says he’s “incredulous” that, after declaring a public health emergency in October, the president still hasn’t requested any money from Congress to combat the epidemic.

“I mean this is just a mental health crisis of the first order,” Kennedy says, “and this administration has done nothing.”

Here’s what the administration has done so far:

  • President Trump declared a public health emergency in October to deal with the opioid epidemic. The declaration brought no new money to fund the federal response.
  • In November, President Trump announced he’s donating his third-quarter salary — about $100,000 — to help the Department of Health and Human Services fight opioids.
  • The Centers for Medicare and Medicaid Services announced a policy change in November that allows states to apply for waivers allowing them to use Medicaid to pay for residential drug treatment at facilities that have more than 16 beds. Some states are already taking advantage of that policy change.
  • President Trump signed the Interdict Act in January giving federal agents additional tools for detecting fentanyl and other synthetic opioids at the border.
  • Also this month, Attorney General Jeff Sessions announced an operation using medical data to crack down on pharmacies and doctors that dispense suspicious amounts of opioids.

Here are things critics point out the administration hasn’t done:

  • There is still no head of the Office of National Drug Control Policy. In October, Trump’s nominee to the position, Rep. Tom Marino, R-Pa., withdrew his name after reports linked him with a bill that limited the DEA’s ability to investigate abuses by opioid manufacturers and distributors.
  • President Trump still hasn’t nominated anyone to head the Drug Enforcement Agency.
  • The administration hasn’t asked Congress for any new funding to address the opioid epidemic.

Roughly 64,000 people died from drug overdoses in 2016, and data from the CDC indicates deaths are rising. Kennedy says what’s needed is a coordinated federal response similar to the one in the mid-1990s — when the U.S. spent $24 billion a year to address the HIV/AIDS crisis.

“We’re talking about a major league crisis and they’re taking credit for little things, while the whole country is burning down,” Kennedy says.

Instead of a big boost in funding, the Trump administration is focused, in many cases, on cutting spending.

In the 2018 budget, the president recommended cutting the Office of National Drug Control Policy budget by 95 percent, and may do so again this year.

A law signed by President Barack Obama that designated a billion dollars to help states combat opioids runs out of money this year. Humphreys has seen no sign President Trump intends to ask Congress to renew that funding.

“The 2018 budget had a $400 million cut to the Substance Abuse and Mental Health Services Administration, which is the lead agency that funds treatment in the United States,” Humphreys says. “So, the administration’s impulse seems to be not to spend more — in fact to spend less.”

The White House is preparing to act on one of the recommendations of its opioid commission—that it launch a campaign to educate the public, especially young people, on the dangers of opioids. The campaign is being developed not by the Office of National Drug Control Policy, but by a team in the White House led by Kellyanne Conway.

The Opioid Epidemic in 6 Charts Designed To Deceive You

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

I do not know Dr. Andrew Kolodny,  personally, and, aside from one brief phone call last year, I have had no contact with him. Therefore I cannot know his motivation for becoming a driving force behind “opioid reform”— a concept which would border on hysterically funny if not for the tragedy that it is causing in this country. 

Dr. Kolodny, a psychiatrist, is the executive director of Physicians for Responsible Opioid Prescribing (PROP)—a group that played a significant role in creating the disastrous CDC Guideline for Prescribing Opioids for Chronic Pain (2016). The CDC ended up incorporating much of PROP’s recommendations, which were supposedly designed to help the US mitigate the damage done by opioid (1) drugs, despite the fact that the “evidence” contained in the recommendations had been carefully scrutinized and found unsupportable by FDA scientists

Since I cannot read his mind, I have no way of knowing whether Kolodny’s efforts are an honest, but misguided, attempt to help, or something else.

But I can read his writings, and based on “The opioid epidemic in 6 charts,” recently published in The Conversation, honesty is not the word that first pops into my mind. Yes, Dr. Kolodny does present 6 charts to explain his version of what I will now call “The Fentanyl Crisis,” (2) but even a quick read of his editorial reveals that it appears to be designed to confuse rather than clarify matters. Let’s take a look. 

Trick #1: Manipulative and misleading statistics.

“Drug overdose deaths, once rare, are now the leading cause of accidental death in the U.S., surpassing peak annual deaths caused by motor vehicle accidents, guns and HIV infection.”

This sentence, the very first of the editorial, doesn’t pass the sniff test. Why?

  • The term “drug overdose deaths” (there are about 60,000 annually) is now standard jargon used to characterize fatalities from all drugs of all sorts, anticoagulants, antidepressants, aspirin, cocaine, etc. But most people will read what Kolodny wrote and arrive at the conclusion that 60,000 people were killed by prescription pain medications. They were not. All opioids together (including heroin) killed 30,000 people. The number of deaths from prescription opioids—the target of the current crusade— was about 17,000— half the number killed by accidental falls.  Are we having an “accidental fall epidemic?” Why not? Accidental falls are killing twice as many people as prescription pain medicines. 
  • The figure 60,000 is, of course, inaccurate, but so is 17,000. This is because opioid overdose deaths are frequently the result of combination with other drugs, especially benzodiazepines, which potentiate the effect of the opioid action. In 2015 almost half (7,500) of the overdose deaths from opioids also involved benzodiazepines (Figure 2). When you include other drugs that are taken with opioids, especially alcohol and cocaine, It can reasonably be assumed that the number of deaths from opioid pills alone will be much lower, perhaps in the neighborhood of 5,000—ten-times lower the 60,000 that Kolodny implies, and roughly the same as bicycle and bicycle-related deaths. This is what the hysteria is about? 

Figure 2. Opioid involvement in benzodiazepine death, And also benzodiazepine involvement in opioid deaths.

 

  • Comparing the number of drug overdose and motor vehicle deaths is pointless, arbitrary and manipulative. What’s more, these unrelated numbers can be interpreted in either of two ways. Annual deaths from auto accidents peaked in 1972—before seatbelt laws were in effect—and decreased by 41% as of 2011. What was responsible for the switch? Was it rising drug ODs? Decreasing auto accidents? Both? Does it matter? No, it doesn’t. It’s a stupid comparison.
  • A comparison to deaths from HIV is similarly meaningless. HIV deaths have declined because of antiretroviral drugs. 

This same sentence could be rewritten to be just as accurate, but send an entirely different, albeit, still pointless message:

“Life in the US  is now significantly safer. The number of annual deaths from automobile accidents, AIDS, and guns is now lower than that from drug overdoses, even when illegal street drugs, such as heroin, are included.”

Trick #2: Telling a half-truth.

“The effects of hydrocodone and oxycodone on the brain are indistinguishable from the effects produced by heroin. “

Yes, they are. But Kolodny omits a vital bit of information — potency. While the physiological effect of hydrocodone on the brain may be the same as heroin (the two drugs hit the same receptors), the functional difference between the two drugs is night and day. The magnitude of the effect is conveniently omitted from this “equation.” Heroin packs a much more powerful punch than hydrocodone, especially at doses that are used by addicts. People can become addicted to heroin (or even die) from a single injection. It is virtually impossible for one hydrocodone pill to kill or addict anyone. The two drugs don’t even belong in the same sentence, even though they happen to belong to the same class of drugs. 

Trick #3: The absence of evidence is not the evidence of absence.

“In cases [of long-term use], opioids are more likely to harm patients than help them because the risks of long-term use, such as addiction, outweigh potential benefit. Opioids have not been proven effective for daily, long-term use.”

  • Trick #3 actually consists of a trick and maybe even a lie. Opioids may not have been proven to be effective for long-term use, but this is because such studies have not been done. This does not mean that opioids have been proven ineffective, even though the wording of this sentence implies this.
  • The “lie” about addiction potential of opiates is perfectly obvious to anyone who has read the literature on addiction. The risk of addiction is very low for pain patients (less than 1%) who take pain medicine to control their pain. Overwhelmingly, addiction arises from recreational, not therapeutic use of these drugs. 

Trick #4: Blame the drug companies.

“The increase in opioid prescription was fueled by a multifaceted campaign underwritten by pharmaceutical companies. Doctors heard from their professional societies, their hospitals and even from state medical boards that patients were suffering needlessly because of an overblown fear of addiction.”

  • This tactic is appallingly unoriginal. There is no better way to shore up a weak argument than to introduce an “enemy.” And if there is one failsafe enemy, it is the pharmaceutical industry. There is little doubt that there was malfeasance taking place, especially involving companies that were pushing the idea that certain drugs were safer than they really were. Purdue, the makers of OxyContin was fined $653 million for its former actions. Other companies are now being investigated. But this is now irrelevant. Assigning blame may score some points with the readers, and provide fodder for trial attorneys, but does absolutely nothing to keep a single OD victim alive. Whatever certain companies did two decades ago is partly responsible for starting today’s fentanyl OD epidemic, but it has nothing whatsoever to do with keeping it going.

Trick #5: Twist the truth

“Why did this happen? A common misconception is that so-called “drug abusers” suddenly switched from prescription opioids to heroin due to a federal government “crackdown” on painkillers. There is a kernel of truth in this narrative.”

Yes, there is, barely. But it is only a small part of the story. What Kolodny cites as a common misconception is probably a result of his twisting what I have written in previous articles (See: No, Vicodin Is Not The Real Killer In The Opioid Crisis and Heads In The Sand — The Real Cause Of Today’s Opioid Deaths). Except I never said this. The reasons for opioid abuse are multifactorial, but there is no question that epidemic began to escalate in 2010, not from any crackdown, but from an improvement in the formulation of abuse-resistant OxyContin and the unintended consequences that followed. This is indisputable:

From this point on, there was a “shortage” of pills, both because of market forces and government intervention. The difficulty in getting pills was clearly responsible for some/most of the switch to heroin. Koldony’s statement itself was a “kernel of truth.” And a rather small kernel at that.

Now let’s look at what is really going on. Figure 3 makes this crystal clear. Despite seven years of increasing “vigilance,” the number of deaths caused by prescription pain medications remains unchanged, yet total opioid overdose deaths have increased dramatically. The reason is obvious. Virtually all of the additional overdose deaths since can be accounted for by increased use of heroin/fentanyl. Prescription pain medicines are much more difficult to get than 7 years ago, and the only result has been suffering by pain patients and no benefit. It could be no other way. Pills are not the primary driver of overdose deaths. They never were. 

Figure 3. The futility of limiting prescription pain medication. The result was more deaths from heroin/fentanyl and nothing else.

Trick #6: Ignore what doctors are saying.

“Here’s another reason not to believe the narrative about a “crackdown” on painkillers leading to a sudden shift to heroin: There hasn’t been a crackdown on prescription opioids.”

To say that there hasn’t been a crackdown on opioid prescriptions is to ignore reality.  Pharmacy chains are imposing bureaucratic barriers on filling prescriptions and denying prescription refills. The US Association of Attorney’s General is lobbying US Insurance providers to revise their formularies to emphasize non-opioid medications in preference to opioids. The Veterans Administration has been directed by Congress to make the CDC prescription guidelines mandatory rather than voluntary.  Hospitals and pain management practices all across America are discharging patients and forcibly tapering down the dose levels of those they retain.

And Kolodny’s statement also contradicts what every single physician I have spoken with has said. (See: Pain In The Time Of Opioid Denial: An Interview With Aric Hausknecht, M.D.). I’m not sure what Kolodny means by “crackdown,” but when doctors are receiving “friendly” warning letters from departments of health and law enforcement agencies, that’s not merely a crackdown. It’s Kristallnacht. 

In closing, although I have questioned whether the intentions of Kolodny and his acolytes are well-meaning or not, it really doesn’t matter to the six million people who are cut off from pain treatment in this country. The resulting “opioid pain refugee crisis” is a national disgrace. As is the undue influence granted to a handful of ideologues, well intended or not. As public policy goes, this may be as cruel as it gets. 

Notes:

(1) The term “opioids” is scientifically meaningless. Technically, “opioid” means a drug that interacts with the same receptors as morphine, etc., regardless of whether the drug is derived from a natural source, for example, poppy. Opiates are a subset of opioids; they are drugs that are found in plants (e.g., codeine) or semi-synthetic derivatives of them. Heroin, which does not occur naturally, is considered to be an opiate because it is made from morphine, which does. Fentanyl considered to be an “opioid” because it is not an opium derivative. These classifications are a distinction without a difference. The term “opiates” is more than sufficient to describe drugs with morphine-like properties. The word “opioid” should be dropped from the English language. 

(2) There is no such thing as an opioid crisis. It is a fabricated term. People who are now dying from overdoses are now (most of the time) dying from fentanyl and its chemical cousins. A far better and more accurate term is “the fentanyl crisis.”