Tag: cdc

Senators Manchin and Braun Are Attempting to Practice Medicine Without a License—And Fighting the Wrong War

Senator Joe Manchin (D-WV) and Mike Braun (R-IN) are still trying to address the fentanyl and heroin overdose crisis—soon to be joined by a methamphetamine and cocaine overdose crisis—by denying chronic pain patients access to pain relief. They have just introduced a bill they call The FDA Opioid Labeling Accuracy Actwhich would “prohibit the Food and Drug Administration (FDA) from allowing opioids to be labeled for intended use of ‘around-the-clock, long-term opioid treatment’ until a study can be completed on the long-term use of opioids.”

Set aside the fact that most pain specialists agree that, in some cases, long-term opioid therapy is all that works for some chronic pain patients. The 2016 guidelines on opioid prescribing put forth by the Centers for Disease Control and Prevention have already been misinterpreted and misapplied by legislators and regulators, leading to forced and rapid tapering off of opioids in many chronic pain patients, causing many to resume lives immobilized by pain, and in many cases, seek relief in the black market or by suicide. It has gotten so bad that the CDC recently issued a “clarification” in April, reminding regulators that the guidelines were only meant to be suggestive, not prescriptive, and did not in any way mean to encourage the rapid tapering of patients on chronic opioids for pain management. Johns Hopkins bioethicist Travis Rieder, PhD delves deeply into this subject and relates his own experiences in his book, In Pain.

What the senators fail to recognize is that patients are not one-size-fits-all. Different patients respond to pain and to pain management differently. Their proposed legislation, if passed, will only serve to exacerbate the unnecessary suffering of patients in pain that the CDC is trying to undue with its guideline clarification.

Meanwhile, they should take a look at the government’s own numbers. The data show there is no correlation between the number of prescriptions written and the incidence of non-medical use of prescription opioids or prescription pain reliever use disorder. And less than 10 percent of opioid-related overdose deaths in 2017 involved prescription pain relievers unaccompanied by other drugs such as cocaine, heroin, alcohol, or fentanyl.

The continued war on patients by politicians and regulators will not get one IV heroin user to take the needle out of their arm. Senators Manchin and Braun need to recognize that the overdose crisis has been on a steady, exponential increase since the 1970s and shows no signs of stopping—and that its ultimate cause is drug prohibition

If they want to get serious about addressing the problem, they should switch their focus to harm reduction. A good way to start would be to repeal the “Crack House” statutes that prevent cities and states from establishing overdose prevention sites called “safe injection facilities.”

Toward a Healthy Relationship with Opioids

In the June 14th Wall Street Journal, Johns Hopkins University bioethicist Travis Rieder, in an excellent essay, shared with readers his battle with pain resulting from a devastating accident, the effectiveness of opioids in controlling the pain, and the hell he went through when he was too rapidly tapered off of the opioids to which he had become physically dependent. Like most patients requiring long term pain management with opioids, he developed a physical dependence, which is often mistakenly equated with addiction by policymakers and many in the media. 

The aggressive schedule launched me into withdrawal, and I learned viscerally, firsthand, what the absence of opioids can do to someone whose brain has become accustomed to them. Those symptoms include increased sensitivity to the very pain that the opioids counteract, as well as extreme flu-like symptoms, insomnia and crippling depression. I came to understand why people sometimes go back onto deadly dangerous drugs: because the alternative is such profound suffering that it makes you want to die.

I have criticized policymakers for their ham-handed approach based upon a misinterpretation and misapplication of the guidelines on pain management with opioids, released in 2016 by the Centers for Disease Control and Prevention, herehere, and here. As explained in an article I co-authored in the Journal of Pain Research in February 2019, this blunt reaction is based upon the false assumption that opioid-related overdose deaths from nonmedical use is primarily a result of doctors treating patients in pain.

In his essay, Dr. Rieder levels similar criticisms:

Perhaps the greatest challenge about them [opioids] today is to resist the urge to be simplistic or reactionary. America’s current crisis of overuse has led some prescribers to avoid the drugs completely, and it has led politicians to occasionally consider ham-fisted policy solutions, like limiting the lengths or dosages of prescriptions regardless of any individual patient’s needs. But when a medication has both risks and benefits, what we need isn’t one-size-fits-all policies but nuance. 

Dr. Rieder was one of dozens of scholars, academics, physicians, and pain experts who signed a letter to the Oregon Health Authority in March, authored by Stanford University Medical School Professor Sean Mackey, urging against the Authority’s plans to force a rapid tapering off of opioids on all of the chronic pain patients in Oregon’s Medicaid system. That letter, plus push-back from patient advocacy groups, caused the Oregon Health Authority to put its plans on hold. It should not be lost on readers of this blog post that such interventions in the practice of medicine and the delivery of health care  are part and parcel of a state-run health care system.

Better Late Than Never?

As I have written many times before, the opioid prescribing guidelines put forth by the Centers for Disease Control and prevention have been criticized for not being evidence-based. This has even caused the Food and Drug Administration to begin the process of developing its own set of guidelines.

In publishing the guidelines, the CDC emphasized they were meant to be suggestive, not “prescriptive,” pointing out that health care practitioners know their patients’ situations better than any regulators and should therefore individualize their prescribing to meet their patients’ unique needs. 

That has not prevented the majority of states from implementing opioid prescribing guidelines that place limits on the dose, amount, and length of time that doctors can prescribe opioids—usually restricting the dose of opioids to a maximum of 90 MME (morphine milligram equivalents) per day. According to the National Conference of State Legislatures at least 30 states have implemented such guidelines. These guidelines have caused many health care practitioners to return to the undertreatment of pain for which they were criticized in the 1980s and 90s. And it has driven many chronic pain patients to desperation as their doctors abruptly taper their pain medication or cut them off entirely.

The American Medical Association has gently criticized the misinterpretation and misapplication of the CDC guidelines in the past. Now two and a half years after the CDC published its guidelines, the AMA has taken a more adamant stand. This week, at the AMA’s interim meeting in Maryland, its House of Delegates resolved:

RESOLVED that our AMA affirms that some patients with acute or chronic pain can benefit from taking opioids at greater dosages than recommended by the CDC Guidelines for Prescribing Opioids for chronic pain and that such care may be medically necessary and appropriate. 

RESOLVED that our AMA advocate against the misapplication of the CDC Guidelines for Prescribing Opioids by pharmacists, health insurers, pharmacy benefit managers, legislatures, and governmental and private regulatory bodies in ways that prevent or limit access to opioid analgesia.

RESOLVED that our AMA advocate that no entity should use MME thresholds as anything more than guidance, and physicians should not be subject to professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the MME thresholds found in the CDC Guidelines for Prescribing Opioids.

Sadly, the opiophobia-driven policy train left the station long ago. As an eternal optimist, my initial reaction is to think, “better late than never,” and to hope this new resolution will cause policymakers to reconsider their misguided policy. But the cynical voice inside me responds with a more negative cliché: “a day late and a dollar short.”

 

 

 

New FDA Initiative Implies CDC Opioid Guidelines Are Not Evidence-Based

On August 22, Food and Drug Commissioner Scott Gottlieb issued a press release announcing the FDA plans to contract with the National Academies of Sciences, Engineering, and Medicine (NASEM) to develop evidence-based guidelines for the appropriate prescribing of opioids for acute and post-surgical pain. The press release stated:

The primary scope of this work is to understand what evidence is needed to ensure that all current and future clinical practice guidelines for opioid analgesic prescribing are sufficient, and what research is needed to generate that evidence in a practical and feasible manner.

The FDA will ask NASEM to consult a “broad range of stakeholders” to contribute expert knowledge and opinions regarding existing guidelines and point out emerging evidence and public policy concerns related to the prescribing of opioids, utilizing the expertise within the various medical specialties. 

Recognizing the work of the Centers for Disease Control and Prevention for having “taken an initial step in developing federal guidelines,” Commissioner Gottlieb diplomatically stated the FDA initiative intends to “build on that work by generating evidence-based guidelines where needed” that would differ from the CDC’s endeavor because it would be “indication-specific” and based on “prospectively gathered evidence drawn from evaluations of clinical practice and the treatment of pain.”

The CDC guidelines for prescribing opioids, released in early 2016 and updated in 2017, have been criticized by addiction and pain medicine specialists for not being evidence-based. Unfortunately, these guidelines have been used as the basis for many new prescribing regulations instituted at the state-level and proposed on the federal level. The American Medical Association and other medical specialty organizations have spoken out against proposed federal prescription limits that are based upon an inaccurate interpretation of the flawed CDC guidelines. 

In May, Commissioner Gottlieb, in a blog post, mentioned he was aware of criticisms as well as complaints by patient and patient-advocacy groups and was interested in developing more “evidence-based information” on the matter of opioids and pain management. 

Now it appears he is taking the next step. While the press release language was diplomatic and avoided any notion of disrespect for the CDC’s efforts, it is difficult not to infer that the Commissioner agrees with many who have been criticizing the CDC guidelines over the past couple of years.

 

Multiple Distinguished Health Care Practitioners Speak Out Against Misguided Opioid Policy

On March 30, Sally Satel, a psychiatrist specializing in substance abuse at Yale University School of Medicine, co-authored an article with addiction medicine specialist Stefan Kertesz of the University of Alabama Birmingham School of Medicine condemning the plans of the Center for Medicare and Medicaid Services to place limits on the amount of opioids Medicare patients can receive. The agency will decide in April if it will limit the number of opioids it will cover to 90 morphine milligram equivalents (MME) per day. Any opioids beyond that amount will not be paid for by Medicare. One year earlier, Dr. Kertesz made similar condemnations in a column for The Hill. While 90 MME is considered a high dose, they point out that many patients with chronic severe pain have required such doses or higher for prolonged periods of time to control their pain. Promoting the rapid reduction of opioid doses in such people will return many to a life of anguish and desperation.

CMS’s plan to limit opioid prescriptions mimics similar limitations put into effect in more than half of the states and is not evidence-based. These restrictions are rooted in the false narrative that the opioid overdose problem is mostly the result of doctors over-prescribing opioids to patients in pain, even though it is primarily the result of non-medical opioid users accessing drugs in the illicit market. Policymakers are implementing these restrictions based upon a flawed interpretation of opioid prescribing guidelines published by the Centers for Disease Control and Prevention in 2016.

Drs. Satel and Kertesz point out that research has yet to show a distinct correlation between the overdose rate and the dosages on which patients are maintained, and that the data show a majority of overdoses involve multiple drugs. (2016 data from New York City show 97 percent involved multiple drugs, and 46 percent of the time one of them was cocaine.)

Not only are the Medicare opioid reduction proposals without scientific foundation, but they run counter to the recommendations of CMS in its 2016 guidelines. As Dr. Kertesz stated in 2017:

“In its 7th recommendation, the CDC urged that care of patients already receiving opioids be based not on the number of milligrams, but on the balance of risks and benefits for that patient. That two major agencies have chosen to defy the CDC ignores lessons we should have learned from prior episodes in American medicine, where the appeal of management by easy numbers overwhelmed patient-centered considerations.”

In an effort to dissuade the agency, Dr. Kertesz sent a letter to CMS in early March signed by 220 health professionals, including eight who had official roles in formulating the 2016 CDC guidelines. The letter called attention to the flaws in the proposal and to its great potential to cause unintentional harm. CMS will render its verdict as early as today.

Until policymakers cast off their misguided notions about the forces behind the overdose crisis, patients will suffer needlessly and overdose rates will continue to climb. 

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CDC Researchers State Overdose Death Rates From Prescription Opioids Are Inaccurately High

In an article in the April 2018 issue of the American Journal of Public Health, four researchers at the Centers for Disease Control and Prevention’s Division of Unintentional Injury Prevention report that the CDC’s methods for tracking opioid overdose deaths have over-estimated the number of those deaths due to prescription opioids, as opposed to heroin, illicitly manufactured fentanyl, and other illicit variants of fentanyl. They called the prescription opioid overdose rate “significantly inflated.”

Fentanyl is a synthetic opioid categorized as a prescription opioid. But, in the outpatient setting, it is predominantly prescribed as a time-release transdermal patch, not suitable for nonmedical users. Occasionally, it is prescribed as a lozenge, a nasal spray, or a small film that can be placed within the corner of one’s mouth, usually to cancer patients in extreme pain. These forms of the drug don’t lend themselves to being converted into a form suitable for nonmedical users wishing to snort or inject the drug. The injectable form of fentanyl is almost exclusively used in the hospital setting, both as an anesthetic agent and to control severe pain in patients who are critically ill or in the postoperative recovery room. Over the past several years, the underground market has been flooded by illicitly manufactured fentanyl and its variants, often moved into the country in a powdered form through the mail.

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More Americans Die in Animal Attacks than in Terrorist Attacks

Comparing the risk of dying in a terrorist attack to a common household accident like slipping in the bathtub is inappropriate.  After all, inanimate objects like bathtubs do not intend to kill, so people rightly distinguish them from murderers and terrorists.  My research on the hazard posed by foreign-born terrorists on U.S. soil focuses on comparing that threat to homicide, since both are intentional actions meant to kill or otherwise harm people.  Homicide is common in the United States, so it is not necessarily the best comparison to deaths in infrequent terror attacks.  Yesterday, economist Tyler Cowen wrote about another comparable hazard that people are aware of, that is infrequent, where there is a debatable element of intentionality, but that does not elicit nearly the same degree of fear: deadly animal attacks.

Cowen’s blog post linked to an academic paper by medical doctors Jared A. Forrester, Thomas G. Weiser, and Joseph H. Forrester who parsed Centers for Disease Control and Prevention (CDC) mortality data to identify those whose deaths were caused by animals in the United States. According to their paper, animals killed 1,610 people in the United States from 2008 through 2015. Hornets, wasps, and bees were the deadliest and were responsible for 29.7 percent of all deaths, while dogs were the second deadliest and responsible for 16.9 percent of all deaths. 

The annual chance of being killed by an animal was 1 in 1.6 million per year from 2008 through 2015.  The chance of being murdered in a terrorist attack on U.S. soil was 1 in 30.1 million per year during that time.  The chance of being murdered by a native-born terrorist was 1 in 43.8 million per year, more than twice as deadly as foreign-born terrorists at 1 in 104.2 million per year.  The small chance of being murdered in an attack committed by foreign-born terrorists has prompted expensive overreactions that do more harm than good, such as the so-called Trump travel ban, but address smaller risks than those posed by animals.