April Grove Doyle, a 40-year-old single mom with metastatic breast cancer, pulled her car to the side of the road. Her face was flushed and her eyes puffy from crying, but she looked into the phone mounted on her dashboard and pressed the record button.
“So, I’m just leaving my pharmacy,” she said, taking a breath to steady herself. “I’m not, I’m not—I’m frustrated, and that’s why I’m crying. I get pain pills, maybe every two, three months, OK? I can make one monthly prescription of pain pills last two or three months because I don’t really take it unless I absolutely need it. And when you have metastatic cancer in your bones, you need it. Because sometimes the pain is so much you can’t even function. And I just want to function.”
After another deep breath, Doyle explained: The pharmacist at her local Rite Aid pharmacy in Visalia, California, had berated her for her history of opioid prescriptions, then told her to come back later. She left without the refill, feeling that she was being treated like a criminal.
Like millions of other chronic pain patients around the country, Doyle is the collateral damage of the opioid abuse epidemic. About 17,000 people die each year in the US from a prescription opioid overdose. Fifty million Americans suffer from chronic pain—one-fifth of the adult population—including 20 million who have what’s called high-impact chronic pain, or pain that frequently limits their daily life.
The campaign to keep opioids away from people who abuse them has ended up punishing the people who use them legitimately—even torturing them to the point of suicide. Now they are pushing back, mobilizing as best they can into a burgeoning movement. “Don’t Punish Pain” rallies are taking place in cities nationwide on May 22, and pain patients are organizing a protest at the Centers for Disease Control and Prevention in Atlanta on June 21.
Doyle posted her video to her Facebook page, The C Life, and by the time she got back to her office after her lunch break, her phone began to bing with notifications. The video has since been viewed about 330,000 times; many of the 1,400 comments came from people with similar experiences. After her post went viral, Rite Aid filled her prescription—and apologized.
“This is not right,” Doyle says. “These medications were created for the very problems we’re having, and yet we’re not being allowed access to them.” (...)
Perhaps the most powerful support comes from pain experts. In March, a group called Health Professionals for Patients in Pain wrote to the Centers for Disease Control and Prevention, urging the agency to respond to the “widespread misapplication” of its 2016 Guideline for Prescribing Opioids for Chronic Pain. Patients were being forced to taper off opioids and were subjected to unnecessary suffering, they said. The letter was signed by more than 300 health professionals, including three former US drug czars.
On April 9, the Food and Drug Administration warned that suddenly decreasing dosage or halting opioids in patients who are dependent on them could lead to “serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.” The next day, the CDC director clarified that the agency’s guideline, which recommends against high doses of opioids, applies to the initiation of opioid treatment and not to patients who have been stable in long-term treatment. (...)
Yet chronic pain patients say many doctors have already stopped prescribing opioids. They fear scrutiny from the Drug Enforcement Administration, state medical boards, or even their own health institutions. Authorities want to shut down “pill mills” that fuel the overdose crisis by providing opioids inappropriately, but those same enforcement efforts can affect doctors who prescribe high doses to chronic pain patients. Oregon, for example, wanted to shift patients from opioids to alternative pain treatment, such as acupuncture, massage, and cognitive behavioral therapy. In 2016, the state required Medicaid patients with back and spine conditions to taper off of opioids.
Sean Mackey, chief of the Division of Pain Medicine at Stanford University, was initially reluctant to enter the fray over opioids. “I prefer to avoid this space because there is so much emotional rhetoric and anger and attacks flying both ways,” he says. “I just want to focus on pain, the research and clinical care of people in pain.” But he felt compelled to speak out against what he calls “a social experiment on a large part of the most vulnerable population.”
Mackey wrote a letter warning that forced tapering poses significant harm without any evidence of safety or effectiveness. It was co-signed by more than 100 pain and addiction experts and patient advocates. “People of good conscience need to step up and say ‘No, this is wrong,’” he says.
by Michele Cohen Marill, Wired | Read more:
Image: Godong/UIG/Getty Images
[ed. Thanks to the CDC, FDA, DEA, grandstanding politicians (TOUGH on drugs!), imbecilic media, chickenshit hospitals, physicians, pharmacies, insurance companies, and everyone else who's complicit in making this epidemic worse than it needs to be, here's the face of normal patients just trying to live a normal life without being treated like addicts.]
Opioid Steering Committee Part 15 Hearing 1/30/18: Our next presenter is Dr. Richard Lawhern.
MR. LAWHERN: Good morning. I'm Richard Lawhern, sometimes called Red. I am cofounder of the Alliance for the Treatment of Intractable Pain. We're an organization of about 200 medical professionals knowledgeable with chronic pain patients and caregivers, healthcare providers, and others. We get a daily reach of about 80,000 viewings from social media. We're here to represent the concerns and interests of three million chronic pain patients who are under regular treatment with opioid analgesics. Organizing a late minute session, I wanted you to have the takeaway points up front and these are going to be a little surprising to some in the audience. First of all, FDA is chasing the wrong opioid crisis. Second, the REMS in its present form will harm hundreds of thousands of patients to no good outcome, and help almost none. And I'll expand on these points in the presentation. Second we implore the FDA, and by the way, the DEA, to stand down from further regulation. Take a breath before you do even more harm than the CDC guidelines already have.We focus on the recall and revision of the CDC opioid guidelines, which right now have a wide level of critics among medical professionals on the grounds that I'm stating here. Those guidelines are dangerously incomplete, they are dangerous to public health, and they should be withdrawn and rewritten on a priority basis. Now here is a chart which in a strange way speaks to the very thing I've just remarked upon. Pill counting and supply restriction are not working and the statistics of the CDC itself demonstrate that. The number of prescriptions peaked in 2011 and began to fall. Since the mandated reformulation of OxyContin, prescriptions of that prescription opioid have dropped by two-thirds, but opioid prescriptions being at a low, overdose deaths due to all sources have continued to ramp up. That should be an immediate indicator that what you're doing isn't working, and I'll speak to that in some greater detail as we go. Now I mentioned that I think you're chasing the wrong opioid crisis. We now know from the CDC statistics that opioid deaths are dominated by street drugs, particularly these four. Prescription drugs are a distant fifth in this mortality rate. We have heard the message parroted over and over that 75% or more of addicts start with prescription drugs, and by the way, and alcohol, but most of these drugs are diverted. They're not prescribed by a doctor to a patient who overdoses on them. Massachusetts did a review and tracked their overdose deaths for a year back to their PMP. They found that fewer than 8% of those who died had a current opioid prescription. Likewise, the typical new addict and the typical pain patient are different people.The demographics don’t work.The typical addict, or if you will, a person with addiction-I don’t want to be disrespectful to any of them-is an adolescent or early 20s male with a chronic history of unemployment, family trauma, and perhaps mental health issues. That population is medically underserved. They come from depressed areas of the US, but the typical pain patient is a woman in her 40s or older who has a history of accident trauma, failed surgery, fibromyalgia, and other diseases that produce chronic pain as a symptom, and older women whose lives are stable enough to see a doctor for a prescription are very rarely addicts. You can't make the trail of bread crumbs between these two demographics. It doesn’t exist. Now there are eight questions in the FDAREMS. I will speak briefly to each as we go. First, should the FDA specify a drug amount threshold for additional risk benefit, review? If you'll pardon my venturing slightly in the vernacular, our answer to this is not only no, but hell no. And there's for good reason. Because the CDC guidelines have already specified such a special and that specification has resulted in doctors leaving the practice and in hundreds of suicides. It is literally of that magnitude or larger. Patients are regularly being deserted, discharged, or coerced into tapering down to subtherapeutic levels of opioids.That's got to get fixed. The guidelines have also created a very hostile regulatory environment. Hospitals are actually refusing to treat palliative care patients with opioids in a few cases.There is no one-size-fits-all patient or treatment plan. Each patient must be treated as an individual and we have seen ample evidence that those limitations and rigid pill counting directly harm patients by forcing them into subtherapeutic levels of therapy. Likewise, we should add that the state regulations which mandate for increased visits and shorter visit times for people coming back for prescription are also helping very few and harming great numbers. Prescriptions being denied at pharmacies is endemic and it's being denied on an abundance of care because these people are afraid of being persecuted out of business by the DEA, and I do mean the term persecuted. Extralegal measures are being used to condemn without a trial people who are being forced out of practice for no good cause. Likewise, the second point in REMS. If you want to ensure compliance, you're going to have to put portals in every doctor's office and in every pharmacy in the country. And the problem we have here is the pain patients themselves are a small minority of all people with addiction. You're going after 100% of a cohort of three million people in order to help solve a problem among maybe eight to ten percent of them. Whatever happened to first do no harm? That certainly isn't a good example. We should also remark that very few doctors who are in normal practice are casual about prescribing. You've been successful in getting their attention and very few patients quickly become addicted. There's something not in my presentation I want to add here. There's a study that I recommend to each of the members on this commission. It was published in this month's British Medical Journal. It examines over 560,000 post-surgical patients prescribed opioids and it finds after following them for an average of two-and-a-half years, that 0.6% reported with a diagnosis of an opioid misuse disorder, 0.6. That means that 99.4% of all patients treated in the short term for largely acute pain do not become addicted. That's a direct contradiction to the CDC nonsense and it is that. It's nonsense. MS. TOIGO: Dr. Lawhern, I don’t want to interrupt, but your, your time is up. DR. LAWHERN: Oh, I beg your pardon. MS. TOIGO: You want to wrap up --DR. LAWHERN: I will --MS. TOIGO: Thank you. DR. LAWHERN: Let's go back to the bottom line and the rest of this you can catch on the update, if you will.The FDA is now chasing the wrong crisis. Overregulation is going to make the real crisis worse by driving patients into the street. It's already happening. You will drive more patients into disability and death if you do not realize the regulation is not the answer. The guidelines must be suspended and the VA Page must be directed to remove and rewrite their practice standard which mandates the elimination of opioids from practice. That is not optional. It is a moral and ethical imperative.]
[ed. See also: this, this and this.]
“So, I’m just leaving my pharmacy,” she said, taking a breath to steady herself. “I’m not, I’m not—I’m frustrated, and that’s why I’m crying. I get pain pills, maybe every two, three months, OK? I can make one monthly prescription of pain pills last two or three months because I don’t really take it unless I absolutely need it. And when you have metastatic cancer in your bones, you need it. Because sometimes the pain is so much you can’t even function. And I just want to function.”
After another deep breath, Doyle explained: The pharmacist at her local Rite Aid pharmacy in Visalia, California, had berated her for her history of opioid prescriptions, then told her to come back later. She left without the refill, feeling that she was being treated like a criminal.
The campaign to keep opioids away from people who abuse them has ended up punishing the people who use them legitimately—even torturing them to the point of suicide. Now they are pushing back, mobilizing as best they can into a burgeoning movement. “Don’t Punish Pain” rallies are taking place in cities nationwide on May 22, and pain patients are organizing a protest at the Centers for Disease Control and Prevention in Atlanta on June 21.
Doyle posted her video to her Facebook page, The C Life, and by the time she got back to her office after her lunch break, her phone began to bing with notifications. The video has since been viewed about 330,000 times; many of the 1,400 comments came from people with similar experiences. After her post went viral, Rite Aid filled her prescription—and apologized.
“This is not right,” Doyle says. “These medications were created for the very problems we’re having, and yet we’re not being allowed access to them.” (...)
Perhaps the most powerful support comes from pain experts. In March, a group called Health Professionals for Patients in Pain wrote to the Centers for Disease Control and Prevention, urging the agency to respond to the “widespread misapplication” of its 2016 Guideline for Prescribing Opioids for Chronic Pain. Patients were being forced to taper off opioids and were subjected to unnecessary suffering, they said. The letter was signed by more than 300 health professionals, including three former US drug czars.
On April 9, the Food and Drug Administration warned that suddenly decreasing dosage or halting opioids in patients who are dependent on them could lead to “serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.” The next day, the CDC director clarified that the agency’s guideline, which recommends against high doses of opioids, applies to the initiation of opioid treatment and not to patients who have been stable in long-term treatment. (...)
Yet chronic pain patients say many doctors have already stopped prescribing opioids. They fear scrutiny from the Drug Enforcement Administration, state medical boards, or even their own health institutions. Authorities want to shut down “pill mills” that fuel the overdose crisis by providing opioids inappropriately, but those same enforcement efforts can affect doctors who prescribe high doses to chronic pain patients. Oregon, for example, wanted to shift patients from opioids to alternative pain treatment, such as acupuncture, massage, and cognitive behavioral therapy. In 2016, the state required Medicaid patients with back and spine conditions to taper off of opioids.
Sean Mackey, chief of the Division of Pain Medicine at Stanford University, was initially reluctant to enter the fray over opioids. “I prefer to avoid this space because there is so much emotional rhetoric and anger and attacks flying both ways,” he says. “I just want to focus on pain, the research and clinical care of people in pain.” But he felt compelled to speak out against what he calls “a social experiment on a large part of the most vulnerable population.”
Mackey wrote a letter warning that forced tapering poses significant harm without any evidence of safety or effectiveness. It was co-signed by more than 100 pain and addiction experts and patient advocates. “People of good conscience need to step up and say ‘No, this is wrong,’” he says.
by Michele Cohen Marill, Wired | Read more:
Image: Godong/UIG/Getty Images
[ed. Thanks to the CDC, FDA, DEA, grandstanding politicians (TOUGH on drugs!), imbecilic media, chickenshit hospitals, physicians, pharmacies, insurance companies, and everyone else who's complicit in making this epidemic worse than it needs to be, here's the face of normal patients just trying to live a normal life without being treated like addicts.]
---
[Addendum.] See also: transcripts of FDA public hearings on the topic. They were definitely warned but chose to ignore it. See: here (heartbreaking) and here (pdfs). Opioid Steering Committee Part 15 Hearing 1/30/18: Our next presenter is Dr. Richard Lawhern.
MR. LAWHERN: Good morning. I'm Richard Lawhern, sometimes called Red. I am cofounder of the Alliance for the Treatment of Intractable Pain. We're an organization of about 200 medical professionals knowledgeable with chronic pain patients and caregivers, healthcare providers, and others. We get a daily reach of about 80,000 viewings from social media. We're here to represent the concerns and interests of three million chronic pain patients who are under regular treatment with opioid analgesics. Organizing a late minute session, I wanted you to have the takeaway points up front and these are going to be a little surprising to some in the audience. First of all, FDA is chasing the wrong opioid crisis. Second, the REMS in its present form will harm hundreds of thousands of patients to no good outcome, and help almost none. And I'll expand on these points in the presentation. Second we implore the FDA, and by the way, the DEA, to stand down from further regulation. Take a breath before you do even more harm than the CDC guidelines already have.We focus on the recall and revision of the CDC opioid guidelines, which right now have a wide level of critics among medical professionals on the grounds that I'm stating here. Those guidelines are dangerously incomplete, they are dangerous to public health, and they should be withdrawn and rewritten on a priority basis. Now here is a chart which in a strange way speaks to the very thing I've just remarked upon. Pill counting and supply restriction are not working and the statistics of the CDC itself demonstrate that. The number of prescriptions peaked in 2011 and began to fall. Since the mandated reformulation of OxyContin, prescriptions of that prescription opioid have dropped by two-thirds, but opioid prescriptions being at a low, overdose deaths due to all sources have continued to ramp up. That should be an immediate indicator that what you're doing isn't working, and I'll speak to that in some greater detail as we go. Now I mentioned that I think you're chasing the wrong opioid crisis. We now know from the CDC statistics that opioid deaths are dominated by street drugs, particularly these four. Prescription drugs are a distant fifth in this mortality rate. We have heard the message parroted over and over that 75% or more of addicts start with prescription drugs, and by the way, and alcohol, but most of these drugs are diverted. They're not prescribed by a doctor to a patient who overdoses on them. Massachusetts did a review and tracked their overdose deaths for a year back to their PMP. They found that fewer than 8% of those who died had a current opioid prescription. Likewise, the typical new addict and the typical pain patient are different people.The demographics don’t work.The typical addict, or if you will, a person with addiction-I don’t want to be disrespectful to any of them-is an adolescent or early 20s male with a chronic history of unemployment, family trauma, and perhaps mental health issues. That population is medically underserved. They come from depressed areas of the US, but the typical pain patient is a woman in her 40s or older who has a history of accident trauma, failed surgery, fibromyalgia, and other diseases that produce chronic pain as a symptom, and older women whose lives are stable enough to see a doctor for a prescription are very rarely addicts. You can't make the trail of bread crumbs between these two demographics. It doesn’t exist. Now there are eight questions in the FDAREMS. I will speak briefly to each as we go. First, should the FDA specify a drug amount threshold for additional risk benefit, review? If you'll pardon my venturing slightly in the vernacular, our answer to this is not only no, but hell no. And there's for good reason. Because the CDC guidelines have already specified such a special and that specification has resulted in doctors leaving the practice and in hundreds of suicides. It is literally of that magnitude or larger. Patients are regularly being deserted, discharged, or coerced into tapering down to subtherapeutic levels of opioids.That's got to get fixed. The guidelines have also created a very hostile regulatory environment. Hospitals are actually refusing to treat palliative care patients with opioids in a few cases.There is no one-size-fits-all patient or treatment plan. Each patient must be treated as an individual and we have seen ample evidence that those limitations and rigid pill counting directly harm patients by forcing them into subtherapeutic levels of therapy. Likewise, we should add that the state regulations which mandate for increased visits and shorter visit times for people coming back for prescription are also helping very few and harming great numbers. Prescriptions being denied at pharmacies is endemic and it's being denied on an abundance of care because these people are afraid of being persecuted out of business by the DEA, and I do mean the term persecuted. Extralegal measures are being used to condemn without a trial people who are being forced out of practice for no good cause. Likewise, the second point in REMS. If you want to ensure compliance, you're going to have to put portals in every doctor's office and in every pharmacy in the country. And the problem we have here is the pain patients themselves are a small minority of all people with addiction. You're going after 100% of a cohort of three million people in order to help solve a problem among maybe eight to ten percent of them. Whatever happened to first do no harm? That certainly isn't a good example. We should also remark that very few doctors who are in normal practice are casual about prescribing. You've been successful in getting their attention and very few patients quickly become addicted. There's something not in my presentation I want to add here. There's a study that I recommend to each of the members on this commission. It was published in this month's British Medical Journal. It examines over 560,000 post-surgical patients prescribed opioids and it finds after following them for an average of two-and-a-half years, that 0.6% reported with a diagnosis of an opioid misuse disorder, 0.6. That means that 99.4% of all patients treated in the short term for largely acute pain do not become addicted. That's a direct contradiction to the CDC nonsense and it is that. It's nonsense. MS. TOIGO: Dr. Lawhern, I don’t want to interrupt, but your, your time is up. DR. LAWHERN: Oh, I beg your pardon. MS. TOIGO: You want to wrap up --DR. LAWHERN: I will --MS. TOIGO: Thank you. DR. LAWHERN: Let's go back to the bottom line and the rest of this you can catch on the update, if you will.The FDA is now chasing the wrong crisis. Overregulation is going to make the real crisis worse by driving patients into the street. It's already happening. You will drive more patients into disability and death if you do not realize the regulation is not the answer. The guidelines must be suspended and the VA Page must be directed to remove and rewrite their practice standard which mandates the elimination of opioids from practice. That is not optional. It is a moral and ethical imperative.]
[ed. See also: this, this and this.]
