How the government creates criminals

http://www.thedailybeast.com/articles/2016/04/15/feds-pill-crackdown-drives-pain-patients-to-heroin.html

The Centers for Disease Control and Prevention issued a broad set of recommendations in March for physicians and treatment facilities that dispense opiate medications. The same week Massachusetts Gov. Charlie Baker signed into law some of the most restrictive regulations ever governing the therapeutic use of narcotic drugs—including limiting first-time prescriptions for opioid pain medication to seven days worth of pills. At least six states have passed similar measures restricting the amount and potency of narcotic medications doctors can prescribe…

[Christopher] Baltz was in his third year of treatment for chronic pain resulting from a severe motorcycle accident and was being prescribed a high dose of oxycodone when Florida Gov. Rick Scott declared war on the state’s robust pain management industry in 2011…

Scott’s crackdown led to the closure of some 400 pain management clinics almost overnight, while a coordinated effort by the Drug Enforcement Administration targeted pharmacies suspected of over-dispensing controlled substances.

This took the form of more aggressive enforcement of a decades-old federal mandate known as “corresponding responsibility” that holds pharmacies legally accountable for ensuring the drugs they dispense are being used for a “legitimate medical purpose.”

In theory, the policy is designed to add another check in the process of preventing drug abuse and diversion. In practice, it places pharmacists in the unwarranted position of policing doctors, and discriminating against patients on the basis of often arbitrary red flags (for instance, paying for their prescriptions in cash).

The net effect of the crackdown in Florida was profound and acute. Prescription drug deaths dropped precipitously within the first year-—but heroin deaths rose 39 percent, as patients cut off from legal opioids turned to illegal drugs for relief…

In spring 2013—two days after receiving a courtesy call confirming his monthly appointment—Baltz showed up at his pain management clinic only to find it had been closed down. Within weeks he was making regular trips to Miami to buy heroin.

“The government wants to prevent people abusing pain medication, but there’s no exit strategy,” said Baltz. “I never even saw heroin until this happened.” …

According to the United Nations, 5.5 billion people around the world already suffer from inadequate pain treatment. This includes roughly a third of all cancer patients in the U.S.

Dr. Webster is one of hundreds of doctors and pharmacies that have been investigated by the DEA since it launched its OxyContin Action Plan in 2001. The plan signaled a shift in federal enforcement tactics away from a focus on illicit street drugs and toward preventing controlled pharmaceuticals from falling into the wrong hands. Over the next 13 years the DEA added more than 1,500 personnel and more than doubled its budget. It also significantly ramped up administrative audits of registrants authorized to dispense controlled substances. (As The Daily Beast reported last year, over the same period the DEA was increasing its quotas of Schedule II pharmaceuticals approved for commercial sale).

During one year alone (2009-2010) the number of regulatory investigations conducted by the DEA’s Office of Diversion Control (responsible for policing prescription drugs) more than tripled, according to the Government Accountability Office…

Federal law requires that all prescriptions for controlled substances be for a “legitimate medical purpose,” but it doesn’t define the term…

Ironically, there is evidence that restricting patient access to pain medicine could actually lead to more overdoses, not fewer. Medical examiners are already unsure of how many deaths attributed to “unintentional overdose” are actually suicides. Chronic pain patients frequently suffer from ancillary mental health problems—including depression, anxiety and insomnia—and are at least twice as likely to commit suicide.

In 2013, when the Department of Veterans Affairs responded to a runaway painkiller problem with a new Opioid Safety Initiative, reports surfaced of patients being cut off their medication without proper dose reductions. Within months the agency came under fire for its new policy when a 52-year-old Navy veteran shot himself in the head in front of an outpatient clinic in Virginia after he was forced off his pain meds.

“The medications were the only thing that was helping him, and when they took that away from him, his life just went downhill,” a friend of the dead man told a local paper…

Meanwhile, there is evidence that the majority of prescription opioids that are diverted for illicit use come from the acute care setting, not the treatment of chronic pain.

I’m not sure that makes sense, if this is also true:

From the New York Times:  “And so although emergency physicians write not quite 5 percent of opioid prescriptions, E.R.s have been identified as a starting point on a patient’s path to opioid and even heroin addiction…”

But perhaps it just shows how small the diversion problem really is, even though we’ve spent so much money (and ruined so many lives) in the effort to combat it.

Dr. Daniel del Portal, who teaches emergency medicine at Temple University’s Lewis Katz School of Medicine, says the modern health care system often incentivizes doctors in acute care settings to find a quick fix for patient complaints. “The pressure is on physicians to make patients happy at any costs,” he told The Daily Beast…

Really? How many doctors have you known that made an effort to make you happy? I don’t ever recall feeling happy after leaving the doctor’s office.

Finally, doctors say there is little use in recommending alternative treatments for patients if they can’t afford them. Pain pills are cheap, and usually fully covered by insurance; physical therapy, chiropractic care, and yoga are expensive, and almost always include co-pays (if they are covered at all)…

Sure, the only reason pain patients don’t use alternative treatments is because of the cost. That really flies in the face of how many pain patients pay out-of-pocket for these alternative treatments, as many are forced to do before they are even given access to opioids.

The fact is that alternative treatments have not proven to be very successful, and their gains are extremely short-lived. This is about treating constant, daily pain, not an injury that will improve over time. For instance, I’m sure there are plenty of pain patients who would welcome a daily massage (if they could afford it), but I would need painkillers before I agreed to let someone work on my body. It would be a treatment that caused more pain, just like so many others I’ve tried. Seems to me that most of the treatments which cause more pain don’t provide as much benefit as their practitioners would have you believe. “No pain, no gain” doesn’t really work when we’re talking about chronic pain.

Another problem is that many of these alternative treatments can be practiced at home, but unless you’re being seen by a doctor, disability insurance companies will question if you’re really suffering from chronic pain. And what’s the point of paying for a doctor if all she can prescribe are these alternative treatments? Because you really don’t need a prescription for yoga, meditation, stretching and exercise, and many other alternative treatments. (Doctors suck.)

Is it time to legalize marijuana in sports?

http://www.sandiegouniontribune.com/news/2015/aug/01/marijuana-sports-opioids-arguments-kyle-turley/

Kyle Turley was watching one of those commercials earlier this year when he decided enough was enough. He was done with synthetic drugs.

A decade-long NFL career left the former San Diego State All-American offensive tackle with a multitude of health issues. Turley’s football injuries broke his body, but he’s also convinced that football did irreparable damage to his brain. He’s struggled with anxiety, headaches, depression and rage issues. In an interview with the Union-Tribune in 2013, he even admitted to having entertained suicide.

To help him deal with his ailments, Turley’s doctors have prescribed a multitude of painkillers, psych meds and muscle relaxants over the years.

Depakote. Wellbutrin. Zoloft. Flexeril. Percocet. Vicodin. Toradol. Vioxx.

You don’t need to know what each of these drugs is designed to do. The point is that dating back to when he blew out his knee at SDSU in 1996, Turley has been on them all at some point, often in different prescribed combinations, over a period that spans almost 20 years.

That ended in February when Turley decided to free himself of all prescription medications and use only marijuana – a move he credits with saving his life…

With California’s liberal medical marijuana policies, access to marijuana was one of the reasons Turley uprooted his family from Nashville, Tenn. back to his hometown of Riverside last April.

Since weaning himself off all prescription drugs three months ago and transitioning solely to medicinal marijuana, Turley has noticed a “night and day difference in his psyche.” He no longer suffers from low testosterone, his libido is back, and his anxiety issues have improved.

“I don’t have as bad depression any more, that’s getting better. The cognitive impairment seems to be getting a little bit better. Life is more manageable, I have more energy and feel more alive,” Turley said. “I don’t think about killing myself any more. Suicidal thoughts and tendencies were part of my daily living.

“At the end of the day, I was losing hope with the synthetic drugs and now I feel better. It’s giving me hope again, helping with depression and anxiety.” …

Who’s side are you on?

http://brainblogger.com/2015/01/30/opioids-for-chronic-pain-an-interview-with-dr-webster-pain-guru/

Opioids for Chronic Pain – An Interview with Dr. Webster, Pain Guru

To develop an addiction, a person must be exposed to the drug. Avoiding the use of opioids whenever possible decreases exposure. Decreasing exposure reduces the chance for the disease of addiction to be expressed…

If an opioid is to be prescribed, an assessment for risk factors should be performed followed by close monitoring for aberrant behavior. Addiction can be triggered with the first dose or develop after prolonged exposure. People with a “loaded” genome may express an addiction earlier than those who are spared many of the genetic risks. People who develop an addiction later may have less of a genetic vulnerability, but the stress associated with chronic pain can tip toward destructive use behaviors. Using urine drug testing and prescription drug monitoring is essential to detecting non-adherence, which could be a sign of addiction.

For more on how to prevent opioid addiction see my book, Avoiding Opioid Abuse While Managing Pain…

I personally believe that the FDA should set a deadline for when all ER formulations must meet a minimum standard of abuse-deterrent properties to remain on the market. If this were to occur, the cost of ER formulations would likely increase, but this may be a reasonable trade-off for potentially safer products. Of course, this move will not eliminate all dangers; people can still overdose if they take multiple pills of an abuse-deterrent formulation…

It is important that prescribers have access to interstate data sharing because patients can easily move from one area to another if they intend to deceive the prescriber. In some cases, physicians can access data from prescription monitoring programs in surrounding states by contacting those states, but this takes more time and work than is desirable. For years there has been a push for a nationally centralized database of prescriptions. However, funding has been lacking to make that happen…

Pain Guru or Addiction Guru?

The Stanford Opioid Management Model

http://www.practicalpainmanagement.com/treatments/pharmacological/opioids/stanford-opioid-management-model

First published on June 1, 2014

It is important to clearly address these responsibilities and expectations at the onset of establishing a treating relationship, particularly when the increasingly controversial subject of opiate medications is involved.

 Risk Identification and Stratification

Patients should be notified prior to their visit that medications will not be prescribed during their first appointment. The purpose of the initial evaluation is to obtain a thorough history and physical examination to ascertain the most appropriate treatment course. The history should include information relevant to the pain condition, past medical history, and psychiatric functioning. A risk assessment tool for substance abuse should be administered in the event that opioid prescribing will be a part of the treatment plan…

Low-Risk Individuals

Patients who are categorized as “Low Risk” on the ORT, present a medication history that corresponds with the CURES [PDMP] report, have a UDS result that is consistent with their prescribed medications, and do not have untreated or undertreated mental health issues are considered at low risk for opioid abuse. Prescribing of opioids may be initiated if it is clinically indicated. Before opioids are prescribed, the patient should sign written documents that explain the risks of opioid therapy and the parameters of treatment…

Consistent UDS results, CURES reports, and appropriate responses in the above areas suggest a lack of contraindications for continued opioid use. However, any deviations in the above parameters would result in the patient being recategorized as being “At Risk” and would prompt a switch to the pathway described in the next section.

At-Risk Individuals

Patients are considered “At Risk” for opioid abuse due to any combination of the following:

-Moderate- or high-risk result on the ORT
-Medication history that does not correspond to the CURES report
-UDS result that is inconsistent with prescribed medications
-Untreated or undertreated mental health issues

An evaluation by a pain psychologist should be obtained for all at-risk patients to identify the nature and extent to which psychological factors may be influencing the patient’s predicament. An additional consultation with an addiction medicine specialist should be obtained for patients at moderate or high risk based on the ORT, incongruent CURES, or inconsistent UDS results.

Upon completion of the additional evaluations, the information should be integrated to identify whether the patient should be recategorized as low risk or if an active substance abuse disorder is present that necessitates formal addiction treatment…

Reasons to Consider Opioid Cessation

It is critical for prescribing providers to actively monitor patients to ensure that use of opioid therapy remains appropriate. The parameters surrounding the number and type(s) of infractions that would result in medication discontinuation should be specified clearly in the agreement. Once the threshold for discontinuation has been reached, providers should initiate a taper. Contraindications for continued prescribing include (but are not limited to) aberrant behavior, lack of functional improvement, and medical complications…

Lack of Functional Improvement

One of the hallmark differences between acute and chronic pain is the fact that the latter lacks a definitive cure; thus, treatment approaches focus on management of the condition. It can be tempting to focus solely on pain palliation when prescribing medication, but optimal pain management treatment should encompass a wider range of factors, including functional status and emotional well-being. Use of activity diaries (documents in which patients track daily activity), monitoring of work absenteeism due to pain, and obtaining corroborating information from family members may facilitate assessment of functioning…

http://www.opioidrisk.com/node/887

Opioid Risk Tool (ORT) Assessment Instrument

Reprinted With Permission from Lynn Webster, MD

I took the test and scored in the “high risk” category.  In fact, I can’t imagine that too many pain patients would score in the low or moderate risk categories, as you (and your family) would have to be saints (or devout Mormons) to do so.  And if you have a large family, then you’ll have a higher risk for family members who have abused drugs or alcohol.

For instance, who doesn’t have a family member that has abused alcohol?  And if you’re an older pain patient, who hasn’t abused alcohol in their youth?  I know I did — not to the point of addiction, but I did some wild partying in my younger days.  Of course, I quit drinking (and partying) a very long time ago.  I can’t remember the last time I had any alcohol, including wine. Still, I’d be penalized for stuff that happened over 25 years ago.

And the test appears to discriminate against men, who get a higher score than women if they’ve ever abused alcohol and/or illegal drugs.  And if you’re a woman who’s been a victim of preadolescent sexual abuse, you get high marks used against you — but if you’re a man, you get no marks at all.

My high risk score just confirms that if I were to see a pain doctor, I would be denied any kind of treatment that included pain medication.  Of course, this test is self-reported by patients, so I could always lie on the questionnaire, as I’m sure many patients do.

http://www.practicalpainmanagement.com/resources/ethics/dea-doctors-working-together

Jennifer Aniston nails her role in ‘Cake,’ living with chronic pain

http://www.sun-sentinel.com/opinion/commentary/sfl-living-with-chronic-pain-20150210-story.html

I was the medical director of an ambulatory surgical center when “Philadelphia” came out, and I recall the executive director of the facility telling me at the time that we were not equipped to accept people with AIDS. Instead, she said, we should shovel them to a nearby hospital. This type of fear fueled prejudices and discrimination for years until “Philadelphia” and icons like Magic Johnson helped to change the discussion surrounding AIDS. The commitment to research and treatment that followed has culminated with an HIV-positive diagnosis’s no longer equating to a death sentence.

Today, we face another epidemic that has degraded lives within a huge swath of our society and another movie portraying how people suffer because of it. Jennifer Aniston will not receive the Oscar, lacking even a nomination for her performance in “Cake,” a movie about living with chronic pain, but in my opinion she deserves recognition. As a physician who has treated people suffering with chronic pain and addiction for 30 years, I can attest that Aniston, in the role of Claire, did an outstanding job and that her behavior and appearance in the movie ring true for a person in severe chronic pain.

Few people realize that the Institute of Medicine has documented 100 million Americans with chronic pain, more than those with heart disease, cancer and diabetes combined. People in pain are often stigmatized as people with AIDS were in an earlier era, dismissed as malingerers, mistakenly judged to be addicted, even labeled as lowlifes. The difficulty is that there is no cure for most severe chronic pain…

Hoping for a movie that could serve as a cultural touchstone to talk about these issues, I saw “Cake” on opening night at 7:00 pm. There were only 24 people in our 300-seat auditorium in my hometown of Salt Lake City, Utah. Granted, the Sundance Film Festival was in town, perhaps pulling potential viewers away, but I feared the low response mirrored the public’s lack of interest in the topic of chronic pain. This is supported by a recent survey by ResearchAmerica that reported only about 18% of Americans think chronic pain is a significant health problem.

Unfortunately, despite Aniston’s fine performance, “Cake” is no “Philadelphia” and is unlikely to spur the same sort of social movement for change. The movie’s primary lack is the context of the bigger story. It does little to portray the heroism of people who struggle daily with pain, their dignity routinely assaulted by family members and doctors who don’t believe them, friends who abandon them, and public and private insurance policies that will not pay for the interdisciplinary care that could help them. Perhaps another movie about a lawsuit demanding justice for pain sufferers who have been denied care could reach “Philadelphia” stature.

“Cake” does have its strengths, though. Claire’s alcohol use, pill overuse and eventual overdose are, unfortunately, accurately portrayed and far too typical of many people in severe pain.

“Cake” also gets the link between chronic pain and suicide right: fully half of people with chronic pain consider suicide, making Claire’s preoccupation with it frighteningly accurate. The CDC reports that about 40,000 deaths per year are from suicides. These, doubtless, include many people trying to escape pain…

Doctors usually have a different perspective than pain patients, but I haven’t been able to find any reviews for this movie from a pain patient.  And I haven’t seen this movie, so I can’t offer one.

Medication monitoring company performs biased study on pot

http://traumadolls.com/2013/11/medical-marijuana-the-next-wave-of-pain-patient-abuse/

http://www.painmedicinenews.com//ViewArticle.aspx?ses=ogst&d=Clinical+Pain+Medicine&d_id=82&i=ISSUE%3a+November+2013&i_id=1010&a_id=24368

Study Shows Marijuana Use May Be Linked to Opioid Noncompliance (2013)

Ft. Lauderdale, Fla.—As medical marijuana use continues to grow, pain practitioners are beginning to ask what effect, if any, its use has on the issue of potential nonadherence to existing pain treatment. Now, a study by a private corporation has revealed that marijuana use is, indeed, associated with potential nonadherence in chronic pain patients prescribed hydrocodone…

No, not indeed, not really at all.

“Physicians have different opinions on whether to test their patients for THC [a compound in marijuana],” said Michael K. DeGeorge, PharmD, associate director of medical affairs at Ameritox, a medication monitoring company based in Baltimore. “Either way, we thought it would be interesting to see if there was an association between marijuana use and nonadherence in patients, to give clinicians some information when implementing urine drug testing as part of their practice.”

You mean, you thought it would be interesting to pay for a study which the company could use to market its services to doctors who treat pain patients.

“I wasn’t really surprised that we found marijuana use to be associated with medication misuse,” Dr. Dawson said in an interview with Pain Medicine News. “But I was very surprised that it rivaled cocaine in terms of its association to other nonprescribed medications.”

Could it be because cocaine isn’t very good at relieving pain?  Can even make pain worse?  For a company that sells drug monitoring services, I’m surprised that ya’ll didn’t know that.

Lynn R. Webster, MD, cautioned against drawing broad-based conclusions from the retrospective study. “The analysis is based on information reported to the company at the time the tests were ordered,” said Dr. Webster, medical director at CRI Lifetree in Salt Lake City, and president of the American Academy of Pain Medicine. “It is therefore difficult to know how accurate the information is. More importantly, almost all hydrocodone is immediate release, and may not be detected if the urine sample is taken outside the detection window. For example, if a patient is prescribed hydrocodone 7.5 mg and the last dose ingested was 12 or more hours before the urine was collected, hydrocodone may not be present. Similarly, we don’t know the dose and we don’t know when the urine samples were collected for the cocaine and THC groups.”

Whether or not physicians should consider regular marijuana testing is a complicated issue given the rift between state and federal laws. “In states where marijuana is illegal, I would recommend testing,” Dr. Webster noted. “I’d also recommend that physicians counsel patients to discontinue use if they find it in their system, since physicians must advocate for legal use of all medications.

Obviously, Dr. Webster is advocating for physicians, not pain patients.

“In states that have legalized marijuana, it’s still probably wise to test for it,” Dr. Webster added. “Here, too, I would recommend physicians advise their patients to discontinue use if they are planning to prescribe a scheduled drug, particularly an opioid. Prescribing an opioid to someone using marijuana—even in states that have legalized it—may present additional legal issues due to federal laws.”

Well, Dr. Webster, if I didn’t know where you stand on treating pain patients as drug addicts, with all the monitoring that entails, I do now.

DEA should not interfere with physicians and pain patients

DEA should not interfere with physicians and pain patients

My comment:

“The DEA can continue to enforce policies that prevent overuse and overdoses. But it must not interfere in the appropriate relationship between physician and patient.”

Seems like the DEA is actually one of the causes of a lot of drug abuse and overdoses, directly or indirectly. The agency is definitely the cause of who knows how many deaths at the hands of law enforcement, not to mention all the victims (and their families) locked up for nonviolent drug offenses.

And then there’s all the pain patients, doctors, and pharmacists who are now victims of the drug war, too.

It’s too late to stop the DEA’s interference in the medical industry — that’d be like trying to, I dunno, stop the drug war.

Dr. Webster, unless you look realistically at why pain patients are drowning, your arguments are just treading water in this fight (if that).

11/21/2014, RB spin-out Indivior says addiction pipeline will deliver

http://www.pharmaphorum.com/news/rb-spin-out-indivior-says-addiction-pipeline-will-deliver

“At the moment, patients have to decide every day whether to stay in treatment – that’s 365 dosing decisions every year – and we can reduce that down to 12.” The product is injected subcutaneously and forms a gel pellet that breaks down slowly over the course of a month…

A similar philosophy underpins Indivior’s new buprenorphine product based on a prodrug – called buprenorphine hemiadipate – which means it can be formulated into a swallowable rather than a sublingual tablet…

While these are all important new products from a clinical perspective, the biggest commercial opportunity will probably come from Indivior’s alcohol dependence treatment arbaclofen placarbil…

Thaxter also said that, as an independent company, Indivior will be actively looking for opportunities to expand its pipeline in the addiction arena with technologies applicable to alcohol, cocaine, methamphetamine and cannabis dependence, among others…

http://www.fiercepharma.com/story/sales-slump-reckitt-pharma-spinoff-indivior-its-first-ever-earnings-release/2015-02-11

2/11/2015, Sales slump for Reckitt pharma spinoff Indivior in its first-ever earnings release

https://clinicaltrials.gov/ct2/show/NCT01848054

5/2/2013, Study to Assess OX219 (Buprenorphine/Naloxone) for the Induction of Treatment of Opioid Dependence

OX219 (Buprenorphine/Naloxone) [Zubsolv®]

Principal Investigator: Lynn Webster Life Tree Pain Clinic, 3838 S 700 E Suite 200, Salt Lake City, UT 84106

Sponsor:  Orexo AB

No Study Results Posted on ClinicalTrials.gov for this Study

Study Completion Date: January 2014

http://www.purduepharma.com/news-media/2010/07/purdue-pharma-l-p-receives-fda-approval-for-butrans-buprenorphine-transdermal-system-ciii/

7/1/2010, Purdue Pharma L.P. Receives FDA Approval for Butrans™ (buprenorphine) Transdermal System CIII

“Healthcare professionals now have an important new option for appropriate adult patients suffering from moderate to severe chronic pain when an opioid may be needed to manage their pain,” said Lynn R. Webster, MD, FACPM, FASAM, Medical Director of the Lifetree Clinical Research and Pain Clinic in Salt Lake City, Utah…

http://www.bizjournals.com/prnewswire/press_releases/2011/03/25/NY71789

SAN CARLOS, Calif., March 25, 2011 /PRNewswire/ — PharmacoFore, Inc., a privately held biopharmaceutical company developing next-generation abuse-resistant prescription drugs, announced that Lynn R. Webster, M.D., FACPM, FASAM, Co-Founder and Medical Director of Lifetree Clinical Research, will introduce the Company’s novel technology during the 27th Annual American Academy of Pain Medicine (AAPM) Meeting.

Dr. Webster’s presentation, titled “New Opioid Formulations and Delivery Systems,” will feature PharmacoFore’s Bio-Activated Molecular Delivery™ (also referred to as Bio-MD™) and MPAR™ technologies…

http://bdsi.investorroom.com/2014-04-07-BioDelivery-Sciences-Announces-Four-BUNAVAIL-Abstracts-to-be-Presented-at-the-2014-American-Society-of-Addiction-Medicine-Annual-Conference

BUNAVAIL utilizes BDSI’s proprietary BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine for the maintenance treatment of opioid dependence, along with the opioid antagonist naloxone, which is intended to serve as an abuse deterrent…

Poster presentation by Lynn Webster, MD
Low-Dose Naloxone Provides an Abuse Deterrent Effect to Buprenorphine Doses

BEMA Buprenorphine is in Phase 3 clinical trials for the treatment of moderate to severe chronic pain and is licensed on a worldwide basis to Endo Pharmaceuticals. Clonidine Topical Gel for the treatment of painful diabetic neuropathy is currently in Phase 3 development…

http://www.drugandalcoholdependence.com/article/S0376-8716(14)01686-X/abstract

Abuse potential study of intravenous oxycodone hydrochloride alone or in combination with intravenous naltrexone in nondependent, recreational opioid users

ALO-02 is an opioid formulation intended to deter abuse; it comprises capsules filled with pellets of extended-release oxycodone hydrochloride surrounding sequestered naltrexone. The abuse potential (i.e., drug liking and high) of intravenous (IV) oxycodone combined with naltrexone, to simulate IV administration of crushed ALO-02 in solution, was compared with IV oxycodone alone and IV placebo in nondependent, recreational opioid users.

http://www.drugandalcoholdependence.com/article/S0376-8716(14)01706-2/abstract

Preliminary report of THC influence on subject ability to discriminate between active opioid and placebo in human abuse liability study

http://www.opioidrisk.com/node/884

ORT: Opioid Risk Tool

Reprinted With Permission from Lynn Webster, MD

Click to access presidents-message-2014-volume15-3.pdf

(2014) Pain and Suicide: The Other Side of the Opioid Story

Three days later I got a call from his daughter. Jack had died from a self-inflicted gunshot wound. He left a note saying he couldn’t live with the pain anymore…

Previously Prominent Pain Doctor Stoops To Hawking Book

(Yet Mum On Conflicts Of Interest)

Opioids for Chronic Pain – An Interview with Dr. Webster, Pain Guru

http://brainblogger.com/2015/01/30/opioids-for-chronic-pain-an-interview-with-dr-webster-pain-guru/

There is debate about whether all extended-release formulations should have abuse-deterrent properties. I personally believe that the FDA should set a deadline for when all ER formulations must meet a minimum standard of abuse-deterrent properties to remain on the market. If this were to occur, the cost of ER formulations would likely increase, but this may be a reasonable trade-off for potentially safer products…

Sure, the cost of drugs have already increased, why not make them even more expensive? This would guarantee a decrease in patients asking for extended release pain medications; Express Scripts would move these drugs up to an unaffordable tier so coverage would be almost non-existent; and then pain patients would be asking for Dr. Webster’s new drug…

Webster: The future of opioid research is exciting. In the not-too-distant future we should be able to replace the current mu agonists with opioids that are not nearly as addictive or associated with the same magnitude of adverse effects. This is a field that is only beginning to produce candidates for further development, but there is real optimism and hope that we will one day have a class of opioid drugs that is closer to the Holy Grail of powerful analgesics without addictive properties than anyone could have dreamed possible…

The future of opioid research is only exciting to those with a financial and vested interest in the outcomes of current research, including Dr. Webster.  I have no problem with research on the “Holy Grail” of powerful analgesics, but if he thinks his product (CR845 — see my post “FDA Zeros In on Abuse-Deterrent Opioids”) fits this description, then he’s either being overly enthusiastic or just plain wrong.

Under comments:

Peter Western • 10 hours ago
There are pain relief alternatives to drugs. I have used wheat cushions…

Here, have a heating pad for your chronic pain… Do they have full-body heating pads?  And how would I move around while using a heating pad (let alone a full-body one)?

FDA Zeros In on Abuse-Deterrent Opioids

FDA Zeros In on Abuse-Deterrent Opioids

[I tried to post this comment at the National Pain Report website on its article for CR845 — twice. But my comment was censored and not posted. Since that’s the first time I’ve been censored on the National Pain Report website, I have to conclude that my comment touched a nerve. After all, who’s afraid of the truth? I’ve also concluded that the website is not really for pain patients — it appears to be a front for the investors involved with CR845. Therefore, I’ve unsubscribed to that website and will no longer be posting there. And I just thought pain patients should be aware of the truth behind the websites they are supporting.]

painkills2
November 11, 2014 at 8:39 pm

At first I thought CR845 was another Celebrex. Then, with a little more digging, I figured out we’re talking about another Suboxone.

From Wikipedia page for “κ-opioid receptor”: “However, KOR agonists also produce side effects such as dysphoria and hallucinations, which limits their clinical usefulness.”

I’m confused. Have these drugs been successful for anything other than the treatment of addiction (if that)? Because most of what I’ve read about this drug’s effectiveness to treat pain is not good (I’m talking about from actual patients, not studies). In fact, I am very interested in hearing from any patients who’ve taken these new biopharmaceutical concoctions.

Additionally, I’ve read that these kinds of drugs are also part of the opioid abuse “epidemic.” I think the worst thing I’ve read about Naloxone was at Wikipedia: “Studies show that to give this to a person in severe pain would be unethical and inhumane.” (Yikes.)

“We really need to find something that doesn’t have rewarding properties that doesn’t lead to addiction,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine, who was the lead investigator in initial studies of the drug.

For 95% of chronic pain patients, we already have drugs that don’t lead to addiction. And it is within that “reward” effect where most pain relief is found. Regardless, most chronic pain patients don’t get “high,” so that’s not the reason that a very small percentage of us become addicted.

What we’ve got here is a treatment for addiction, not pain. It just so happens that addiction causes pain — but most chronic pain patients are not suffering from that kind of pain.

As for the percentage of the population who suffer from addiction at any given time, they will use whatever drugs are available and affordable — regardless of the sorcery of the biopharmaceutical industry. What, you think doctors and scientists know more about drugs than addicts?

Ya’ll should be studying and researching endocannabinoids — that’s the future. If you’re against the psychoactive effect, then just look at CBDs other than THC — I think there are over 70 of them (so far).

Use and Abuse of Prescription Opioids: Current Evidence (2011)

Abuse-Deterrent and Tamper-Resistant Opioid Formulations: What Is Their Role in Preventing Prescription Drug Abuse?

Lynn R. Webster, M.D., FACPM, FASAM, Medical Director, Lifetree Pain Clinic, Salt Lake City, Utah

http://www.asam.org/docs/default-source/publications/asam-news-archives/vol26-3.pdf?sfvrsn=0

Integration of these formulations in clinical practices based on universal precautions should help further minimize the risk of opioid abuse while fostering appropriate prescribing to patients with indications for opioid therapy.  Abuse- and tamper-resistant opioid formulations are emerging tools that may enhance safe opioid prescribing; further research and postmarketing analysis will clarify their utility and role in clinical practice.

This was in 2011 — so, Dr. Webster, how are those “tamper-resistant” formulations working out? Let’s let Mr. Kolodny from PFROP tell us:

12/4/2014:  Similarly, efforts to curb prescription painkiller abuse — for example, creating “abuse-deterrent” capsules — don’t seem to be as effective as hoped. “Making pills harder to crush and snort doesn’t make them less addictive,” says Kolodny…

Utah, #10 on the list of States Where People Live Longest

http://udohnews.blogspot.com/2014/08/cdc-awards-utah-1-million-to-address.html

8/14/2014, CDC Awards Utah $1 Million to Address Prescription Drug Overdose Prevention

(Salt Lake City, UT) – The Centers for Disease Control and Prevention has announced that Utah will be one of five states in the country to receive more than $1 million over the next three years to help prevent prescription drug overdoses and address the patient and prescribing behaviors that drive it…

Data from the Utah Department of Health (UDOH) show:

• An average of 21 adults died each month from prescription drug overdose in Utah. Oxycodone, methadone, and hydrocodone are the top three prescription pain medications that contributed to these deaths.

• Utah has the fifth highest rate of drug overdose deaths in the United States. In 2011, Utah had 19.5 drug overdose deaths per 100,000 people compared to 13.2 deaths per 100,000 people in the U.S. In 2012, 261 people died from prescription pain medication overdoses in Utah.

• Opioid prescribing rates in Utah are higher than the U.S rate. In 2012, Utah providers wrote 85.8 opioid pain reliever prescriptions per 100 people (individuals may have had more than one opioid pain reliever prescribed to them), the twenty-second highest prescribing rate in the country and above the U.S. rate (82.5/100 people).

• 24.5% of Utahns reported using some type of prescribed opioid during the previous year. Most Utahns who die from a drug-related death suffer from chronic pain and take prescribed pain medications. (2008 BRFSS)

This new funding will give states a surge of resources and direct support from CDC to apply the most promising prevention strategies. Overall, CDC has committed $6 million over the next three years to help five states (Kentucky, Oklahoma, Tennessee, Utah and West Virginia) improve their prescription drug monitoring programs, and conduct rigorous state policy evaluations to understand the most effective prevention strategies.

In an era of budget cuts — like to payments for Medicaid doctors — who do you think is funding the CDC’s war against pain patients?  Perhaps the funds are from the ACA?

http://www.cnn.com/2013/12/20/health/pain-pillar/

12/20/2013, Prominent pain doctor investigated by DEA after patient deaths

What makes the allegations against Lifetree so stunning: Before it was sold in 2010, the clinic was run for more than a decade by Dr. Lynn Webster, an anesthesiologist and pain medicine specialist who is considered a leading expert on how to safely prescribe opioids — drugs that act on the brain to dull a person’s perception of pain.

I don’t know Dr. Webster’s history, but I assume this account is going to be one-sided…

“Dr. Webster teaches a system that supposedly makes this treatment safe and effective,” said Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing. “But when you think about the fact that he’s had multiple deaths in his clinic from overdose, it suggests that the system he is teaching is seriously flawed.”

Ah, the arrival of Mr. Kolodny… It’s so funny, when I read statements from Kolodny, I hear tiny squeaking noises, like… a mouse.

About three people die every hour in the United States after overdosing on prescription drugs, according to the Centers for Disease Control and Prevention; most of those deaths involve prescription opioids. Utah has one of the highest drug overdose rates in the country…

In fact, the longer a patient takes high doses of prescription opioids, the more likely they are to become addicted and eventually overdose. Many pain management experts say overprescribing is at the heart of the overdose problem.

I’m too tired to point out what’s wrong with these statements…

“If you listen to what some of the leading pain specialists are saying today about opioids, they’re saying these past 15-20 years have been a disaster,” said Kolodny, a psychiatrist and chief medical officer at the Phoenix House, a nonprofit addiction treatment organization. “We’re harming far more of our patients than we’re helping when we prescribe opioids aggressively.”

Ah, Kolodny, what are we gonna do with you?

And now we have another grieving loved one playing the blame game:

Webb said his wife complained about migraines and jaw pain, and for years found relief with 30-pill-per-month prescriptions of Tylenol 3 and 4, painkillers containing acetaminophen and codeine. “One day she took a little bit too much medication and felt good,” said Webb. “So then she did it again, and did it again, and did it again, and then pretty soon the 30 pills wasn’t working.” 

Gee, I wonder if his wife would describe what happened in the same way?  Sounds like her jaw pain was getting worse… Maybe her husband wanted her to have surgery instead of drug therapy?

Tina Webb was accused of doctor shopping — going from doctor to doctor to get multiple pain prescriptions filled — and in 2005 was referred to Lifetree for monitoring. When she began treatment there, it was under an agreement with the district attorney. According to a document related to her case, she “…recognizes that she has not managed her pain appropriately,” and needed monitoring by a pain management clinic. But monitoring is not what Tina Webb got at Lifetree, said Webb. She was first seen by Webster, then on subsequent visits had her care handled by a nurse practitioner.

Okay, Tina shouldn’t have been doctor shopping, but was it a sign of addiction or a sign of under-treated pain?  A district attorney involved with the treatment of pain… that’s just sad.

According to an analysis of her medical records, by a physician retained by Webb’s attorney, her dosages had increased by 600% since her first visit.

Hmmm… this does sound… funky.

Roy Bosley said he got the same response when he tried to contact Lifetree staff, including Webster, about Carol Ann Bosley‘s behavior… Soon afterward, Bosley said, his wife lost weight and shed her dependence on prescription opioids, managing her pain on Tylenol only. 

Wow, that’s an amazing transformation… Wonder how her liver and kidneys were handling all that Tylenol?

But just as she was adjusting to a life free of painkillers, Bosley said she got a phone call from Lifetree, requesting that the Bosleys both meet with Webster. During that meeting, Roy Bosley said Webster convinced his wife to resume taking prescription opioids. Just over a year later, in November 2009, Carol Ann Bosley died of an overdose.

“Adjusting to a life free of painkillers”?  That doesn’t sound good… And it doesn’t make sense that a doctor would convince a pain patient to “resume” taking opioids.  Obviously, there was a problem…

A few weeks after she died, Roy Bosley said he was surprised to find that her death certificate listed “suicide” as the cause of death. He said he broached the issue with the medical examiner, and was stunned by his response. “I said, ‘Why did you label it suicide?’ And he says ‘Well, I called Dr. Webster. He told me that she committed suicide.'”

Dr. Edward Leis, the medical examiner who performed Carol Ann Bosley’s autopsy, denied having a conversation with Webster about her case. He said the original determination of suicide was made based on elevated levels of prescription oxycodone and alprazolam (a painkiller and a sedative) in Carol Ann Bosley’s system when she died.

So, why suicide and not unintentional overdose?

Leis said the amendment to her death certificate — although changes like that do not happen often — took into account additional information that Bosley provided about his wife’s state of mind before her death.

I can imagine what Mr. Bosley had to say about his wife… Should his grief be used in a medical document?

Similar to Carol Ann Bosley, after years of addiction, Tina Webb stopped taking painkillers. But it only lasted a month. Soon she was back at Lifetree asking to be prescribed opioids. Reluctantly, Bruce Webb said he participated in her new treatment plan, which involved him helping to administer his wife’s medication.

Damn, a babysitter…

What he did not know — what he said the staff at Lifetree never told him — is that Tina had become “opiate naive.” Her body could not handle pain medication at the level she was previously prescribed. “They put her back on the same drugs, the same dose,” said Webb, echoing an allegation in the lawsuit he filed against Webster and Lifetree. “So she took six pills that day (she died). That’s all it took.”

That sounds made up… As long as I was on — and off — opioids, I never became “opiate naive.” Perhaps his wife couldn’t take the pain (and all the monitoring) anymore.

“Sadly, the number of people with chronic pain has exploded over the last 10 years, escalating the problem of pain to an urgent, national crisis, one which demands a direct and honest dialogue that currently is not happening,” Webster’s statement said. “We need safer, more effective therapies and, ultimately, need to replace opioids as a treatment method so these tragedies never happen.”

Well, just as I thought, it looks like Dr. Webster went over to the dark side… Not that he didn’t have good cause to do so — nobody messes with the DEA. And there’s also that “new” Big Pharma drug that Dr. Webster is researching and funding…

Even years after their deaths, questions linger for both men; and the pain still smarts. It has been particularly difficult for Webb, who has tried to make sense of the loss for his two sons. He said, “…the heartache, the pain, the sleepless nights. It continues on. It’s not done.”

Yes, the blame game must go on… and on… and on. It’s called the Drug War.

Utah family awarded $1.6 million verdict over patient’s combined painkiller overdose death

Utah family awarded $1.6 million verdict over patient’s combined painkiller overdose death

A family of a Utah man who died from a combined drug overdose caused by treatment with opioid painkillers and other medications has been awarded a $1.6 million verdict against the hospital where the overdose occurred…

Lawyers Against Pain Patients:  Prescription painkillers are among the deadliest drugs used by patients in the U.S., according to FDA statistics.

4/18/2013, FDA’s Rejection Of Generic OxyContin May Have Side Effects

http://www.northcountrypublicradio.org/news/npr/177602393/colleague%20http:/www.cidrap.umn.edu/news-perspective/2014/09/commentary-health-workers-need-optimal-respiratory-protection-ebola

It would be “disastrous” to market generic OxyContin without making it abuse-resistant, [Dr. Lynn] Webster says. “There should be no opioids on the market that don’t have some abuse-deterrent formulation.”

Why, Dr. Webster, could your opinion have been influenced by the drug study you’re conducting?

But about one-quarter of abusers say they’ve figured out how to defeat the deterrent, according to a 2012 article in the New England Journal of Medicine.

“A pill that’s harder to snort or inject isn’t necessarily less addictive,” says Andrew Kolodny, head of psychiatry at Maimonides Medical Center in New York, who studies policy on opioid drugs. People also get addicted by swallowing pills, he notes.

Huh?

“One of my concerns is that this new rule could set up an arms race for the pharmaceutical companies to create abuse-deterrent versions because they have patent protection,” Kolodny told Shots. “You’ll see marketing to prescribers that these pills are less addictive. That could potentially make things worse.”

An arms race?  Seriously?

Definition of “arms race”:  a competition between nations for superiority in the development and accumulation of weapons, especially between the US and the former Soviet Union during the Cold War.

Mr. Kolodny is now comparing drugs to military weapons?  I swear, this guy is never happy. But he’s very good at setting up excuses for why things are getting “worse.”

Hey, Kolodny, whatcha gonna do when the DEA starts restricting your treatment drugs of choice?  One which happens to have the abuse deterrent that you’re complaining about?  First, they came for oxycodone, then hydrocodone, then…

Dr. Lynn Webster

11/5/2014, Pain Experts Say New Opioid Has ‘Enormous’ Potential

“There’s a great opportunity for drugs like that. We really need to find something that doesn’t have rewarding properties that doesn’t lead to addiction,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine, who was the lead investigator in initial studies of the drug.

http://americannewsreport.com/nationalpainreport/pain-experts-say-new-opioid-has-enormous-potential-8825096.html

10/29/2014, Cara’s pain drug clears an abuse hurdle as it trots toward Phase III

http://www.fiercebiotech.com/story/caras-pain-drug-clears-abuse-hurdle-it-trots-toward-phase-iii/2014-10-29

12/13/2012, Is The Era Of OxyContin Abuse Over?

“I can’t understand it, says Dr. Lynn Webster, the incoming president of the American Academy of Pain Medicine, and author of “Avoiding Opioid Abuse While Managing Pain: A Guide for Practitioners, “Canada has just taken a very dangerous step.” He believes, by contrast, that in the US, the Food and Drug Administration should “only approve drugs with abuse resistant properties.”

http://www.forbes.com/sites/trevorbutterworth/2012/12/13/is-the-era-of-oxycontin-abuse-over/