Tag: cdc

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.

Feds To Young Women: Don’t Even Touch Alcohol Unless You’re On Birth Control

With the passage of the Twenty-first Amendment in 1933, the United States enacted Repeal and abandoned its failed experiment with Prohibition. And that settled that, right? At least until this week:

Women of childbearing age should avoid alcohol unless they’re using contraception, federal health officials said Tuesday, in a move to reduce the number of babies born with fetal alcohol syndrome.

“Alcohol can permanently harm a developing baby before a woman knows she is pregnant,” said Anne Schuchat, principal deputy director of the Centers for Disease Control and Prevention. “About half of all pregnancies in the United States are unplanned, and even if planned, most women won’t know they are pregnant for the first month or so, when they might still be drinking.

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Proposed Stricter OSHA Regulations on Airborne Silica Exposure Seem Needless

The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) is soon set to release new exposure limits to air-borne silica dust. The rulemaking has been in the works for about three years with a final rule scheduled to be announced this year. The silica industry is not enthused.

Silica dust is known to cause respiratory illnesses (e.g., silicosis, lung cancer, other airways diseases) that may contribute to or lead directly to death when it is breathed in high enough concentrations over long enough time periods.

OSHA explains that exposure to respirable silica “occurs in operations involving cutting, sawing, drilling and crushing of concrete, brick, block and other stone products and in operations using sand products, such as in glass manufacturing, foundries and sand blasting.”

OSHA’s proposal, generally, is to lower the existing permissible exposure limits (adopted in 1971) by about 50%, dropping them from around 0.1mg/m3  to 0.05mg/m3 (specific details here). OSHA explains:

The agency currently enforces 40-year-old permissible exposure limits (PELs) for crystalline silica in general industry, construction and shipyards that are outdated, inconsistent between industries and do not adequately protect worker health. The proposed rule brings protections into the 21st century.

And, as the government likes to claim with all of its regulations, the added restrictions will save lots of lives, and in doing so, will save lots of money:

OSHA estimates that the proposed rule will save nearly 700 lives and prevent 1,600 new cases of silicosis per year once the full effects of the rule are realized.

The proposed rule is estimated to provide average net benefits of about $2.8 to $4.7 billion annually over the next 60 years.

Interestingly, a visit to the Centers for Disease Control in search of deaths from silica inhalation produces this chart graphing silicosis mortality over time. The numbers have dropped considerably over the past 40+ years, and by 2010 had fallen to about 100 or so deaths per year (U.S. residents over the age of 15) attributed to silicosis as either the underlying or contributing cause.

Figure 1. Silicosis: Number of deaths, crude and age-adjusted death rates, U.S. residents age 15 and over, 1968–2010 (Source: CDC).

Figure 1. Silicosis: Number of deaths, crude and age-adjusted death rates, U.S. residents age 15 and over, 1968–2010 (Source: CDC).

The CDC data shows that silicosis deaths have been declining and although the decline has slowed, it continues to drop while under the current OSHA guidelines. And further, the 100 or so deaths that are occurring annually are several times less than the annual number of deaths that OSHA predicts will be saved by the new regulations. That’s a pretty neat trick—the new regs are going to save several times more lives than are actually lost!