Topic: Health Care

How Jailing Drug Users Increases Opioid Overdoses

The standard view of the opioid epidemic blames pharmaceutical companies and doctors for excessive prescribing. An alternate view blames government for outlawing or restricting access to opioids.  In this view, users overdose not from medical use but from consuming diverted or black market opioids of unpredictable quality and potency.

Current restrictions also causes overdoses by enforcing abstinence on people, who then lose their tolerance to opioids.  Some such people nevertheless return to their pre-abstinence dose, with disastrous consequences, when no longer forced to abstain.  A key illustration is released prisoners.

A study by Harding-Pink and Frye (1988) examined 102 sudden deaths of prisoners that occurred within 17 years of their release. The study found that of the 102 deaths, 42 were drug related. Further, while 41 percent of the total deaths were drug-related, 66 percent of the deaths within one year of release were drug-related. The study also found that 60 percent of all of the drug-related deaths occurred within the first year, and the first year had twice as many drug-related deaths as the next three combined.

Binswanger et. al. (2007) examined the deaths of all inmates released from Washington State Department of Corrections from 1999-2003. Overdoses caused a quarter of all deaths, with a yearly mortality rate of 181 per 100,000, 13 times the rate of an average Washington state resident. Further, over a quarter of the total post-release overdose deaths occurred within the first two weeks of release. A yearly mortality rate of 1840 per 100,000 is 129 times the rate of the average Washington state resident.

Maryland’s Department of Health released a similar study in 2014. Between 2007 and 2013 the department monitored the opioid overdose rate of individuals who had been released from jail or prisoner for one year after release. Prisoners were 8.8 times more likely to die of an overdose in their first 7 days of release compared to 91-365 days after release. The opioid-related mortality rate of inmates within their first year of release was 70 per 100,000, 6 times greater than Maryland’s opioid-related death rate in 2012 of 11 per 100,000. In the first week of release, where 58 percent of the opioid-related deaths occurred, the yearly mortality rate was 2080 deaths per 100,000, 190 times the Maryland mortality rate!

All these studies suggest the alternative explanation for the opioid epidemic – more restrictions, more deaths – rather than the standard view – more prescribing, more deaths.

 

Theseus Schulze contributed to this blog post.

Is FDA Commissioner Realizing That America’s War on Opioids Has Become a War on Patients?

In a May 14 blog post, Food and Drug Commissioner Scott Gottlieb expressed concern about the effect the nation’s restrictive policy towards the manufacture and prescription of opioids is having on patients with chronic pain conditions. This is one of the first signs that someone in the administration has taken note of the unintended consequences of this misguided policy—a policy that is based upon the false narrative that the overdose crisis is primarily the result of doctors prescribing opioids to patients in pain.

In response to a wide range of public input solicited by the FDA beginning in September 2017, Commissioner Gottlieb stated:

We’ve heard the concerns expressed by these individuals about having continued access to necessary pain medication, the fear of being stigmatized as an addict, challenges in finding health care professionals willing to work with or even prescribe opioids, and sadly, for some patients, increased thoughts of or actual suicide because crushing pain was resulting in a loss of quality of life.

Pointing out that, “In some medical circumstances, opioids are the only drugs that work for some patients,” Dr. Gottlieb announced that a public meeting will be held on July 9 on “Patient-Focused Drug Development for Chronic Pain,” and invited pain patients to offer their perspectives.

Hinting at his dissatisfaction with the 2016 one-size-fits-all opioid prescription guidelines published by the Centers for Disease Control and Prevention that have greatly influenced state and federal opioid policymakers, he signaled that the FDA is considering proposing its own set of guidelines. Unlike the CDC guidelines, which are not evidence-based and were never intended to be prescriptive, Gottlieb stated:

In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren’t over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments. We will take the first steps toward developing this framework in the coming months, with the goal of providing standards that could inform the development of evidence based guidelines.

Opioid prescriptions peaked in 2010, and high-dose opioid prescriptions are down more than 41 percent since then. Yet the overdose rate continues to climb year after year, with fentanyl and heroin being the major culprits while overdoses from prescription type opioids have stabilized and have even slightly receded. The overdose problem was never really primarily caused by doctors treating patients in pain. It has always been principally due to nonmedical users accessing opioids in the illegal market. And as prescription opioids have become less accessible to them, they are migrating over to more dangerous drugs. The present policy towards the problem is making patients suffer while, at the same time, driving up the death rate. 

This is the first indication that a significant member of the Administration might be coming to that realization.

Are “Fatal” Opioid Concentrations Really Fatal?

When medical examiners conclude that the cause of death is opioid overdose, they rely primarily on the opioid blood concentration level in comparison to a pre-determined “fatal” cutoff. This approach is potentially inaccurate; the fatal ranges used are wide, and they overlap significantly with the ranges for living opioid users.

Numerous fatal ranges have been quoted for methadone: 220-3040μg/L (mean, 1371), 320-2980μg/L (mean, 772), and 600-3000μg/L. Baselt’s Disposition of Toxic Drugs and Chemicals in Man found fatal levels of 400-1800μg/L (mean, 1000) and 60-3100μg/L (mean, 280). These ranges are much too broad for determining cause of death because they include ranges experienced by many living users.

Worm et al. (1992) compared the methadone blood concentration levels of individuals who reportedly died from methadone toxicity while in treatment, out of treatment, or living: 30–1240μg/L (mean, 470), 30–990μg/L (mean, 270), and 30–560 μg/L (mean, 140). While the mean was lower for living methadone users, the ranges overlapped substantially.

Loimer and Schmid (1992) found a blood concentration range of 20–1308 μg/L (mean, 451.4) after a moderate oral methadone dose in 104 living addicts. Gagajewski and Apple (2003) found blood concentration ranges in deaths where methadone was an incidental finding of 180-3000 μg/L (mean, 1100 μg/L). In contrast, by Milroy and Forrest (2000) found the mean methadone range for those who reportedly died from methadone toxicity as 584–2700μg/L (mean, 584), with the majority under 500 μg/L.

Karch and Stephens (2000) compared the blood concentration levels between deaths “caused” by methadone toxicity and deaths where methadone was an incidental finding; they found no statistically significant difference.

Fatal morphine to blood concentrations from heroin use also vary widely. The minimum fatal concentration under North Carolina standards is 100μg/L, and Baselt has given fatal ranges of 50-3000 μg/L (mean, 430) and 10-1100 μg/L (mean, 300). Steven Karch, in his book Pathologies of Drug Abuse, examined twelve studies regarding fatal morphine concentrations and also found a wide range of fatal levels, from 100-2800 μg/L.

Darke et al. (1997) compared morphine concentration levels of current heroin users and heroin overdose deaths. Heroin-related deaths had a higher median concentration (350μg/L versus 90μg/L), but the concentrations overlapped substantially. In particular, a third of current users had morphine concentrations double the “fatal” level of blood morphine concentration.

Darke et al. (2007) compared the morphine concentration levels in deaths ruled morphine toxicity with those ruled homicide but with morphine in the body, finding no significant difference between the two groups.

With fatal toxic concentrations levels being so broad and overlapping with ranges that many addicts live with, a toxicology report is of little help when determining the cause of death. These broad ranges can skew medical examiner’s reporting and lead to an overrepresentation of heroin and methadone overdoses.

Theseus Schulze contributed to this blog post.

New Research Reinforces Earlier Studies Suggesting PDMPs Are Adding to Opioid Overdose Rate

study published last year by researchers at the University of Pennsylvania and Pennsylvania State University found that state Prescription Drug Monitoring Programs (PDMPs), a popular method used to drive down the opioid prescription rate, do not drive down opioid overdose death rates, but might have the unintended consequence of adding to them, by driving users to the underground market where dangerous drugs like fentanyl and heroin await them. Another study last October by a Purdue University researcher found that while PDMPs drove down the prescription rate of oxycodone, they significantly drove up the rate of heroin use.

Yesterday the Annals of Internal Medicine published a systematic research review by Columbia University epidemiologist David Fink and others that drew the same conclusion. The authors stated, “Evidence that PDMP implementation either increases or decreases nonfatal or fatal overdoses is largely insufficient, as is evidence regarding positive associations between specific administrative features and successful programs.” They added, “implementation of PDMPs may have unintended negative outcomes—namely, increased rates of heroin-related overdose.”

Meanwhile, all 50 states have implemented PDMPs and state and federal policymakers seem focused on beefing them up. This is driven by the mistaken belief that the opioid overdose rate is primarily the result of doctors over-prescribing opioids to patients. As I have written numerous times, the overdose crisis is primarily a product of drug prohibition, as non-medical users access drugs in the dangerous black market. PDMPs might be responsible for the dramatic drop in the opioid prescription rate these last 8 years (the rate peaked in 2010), but as the prescription rate has dropped the overdose rate has increased—while fentanyl and heroin are now causing these overdoses the majority of the time.

How much more evidence will it take before policymakers finally realize their approach is not evidence-based but is contributing significantly to the overdose crisis?

Does Marijuana Legalization Cause Pedestrian Fatalities?

A recent report from the Governors Highway Safety Alliance suggests that the legalization of recreational marijuana in many U.S. states has been associated with increases in pedestrian traffic fatalities. To substantiate this claim, the report cites that:

“[t]he seven states (Alaska, Colorado, Maine, Massachusetts, Nevada, Oregon, Washington) and DC that legalized recreational use of marijuana between 2012 and 2016 reported a collective 16.4 percent increase in pedestrian fatalities for the first six months of 2017 versus the first six months of 2016, whereas all other states reported a collective 5.8 percent decrease in pedestrian fatalities.” 

This statistic, however, does not indicate the impact of legalization on pedestrian fatalities because many states did not legalize between the time periods cited.  An appropriate analysis should examine what happens, state-by-state, at the time of each state’s own legalization.

The graphs below depict pedestrian fatalities for states that legalized recreations marijuana between 2012 and 2016. The red lines represents the year in which the state legalized.  The graphs suggest no relation between legalization and pedestrian deaths.

Pedestrian Fatalities by State

For the states that did legalize in 2016 (Maine, Massachusetts, and Nevada), the provisional January-June 2017 used in the GHSA report are the only data available for comparison. Between January-June 2016 and January-June 2017, these three states saw an average increase in pedestrian fatalities of 4 percent.
However, on average, all states saw an average decrease of 12% in pedestrian traffic fatalities in the first six months after legalizing relative to the same six months of the prior year, indicating no clear effect of legalization on pedestrian traffic fatalities.

percent change

Percent Change in Traffic Fatalities

The concern about legalization and traffic fatalities is also inconsistent with several recent studies on the topic. One study, published in the American Journal of Public Health, concluded that “[t]hree years after recreational marijuana legalization, changes in motor vehicle crash fatality rates for Washington and Colorado were not statistically different from those in similar states without recreational marijuana legalization.”

Additionally, preliminary research indicates that marijuana legalization may reduce traffic fatalities. In their study of statewide medical marijuana liberalization, Anderson et al find that “the legalization of medical marijuana is associated with a 13.2 percent decrease in fatalities in which at least one driver involved had a positive BAC level.”  Marijuana and alcohol are substitute goods, meaning that consumers’ preferences are often indifferent between the use of one good or the other. By allowing individuals to legally use marijuana, many choose to do so instead of using alcohol, thus decreasing the prevalence of drunk driving. Furthermore, medical marijuana legalization does not seem to result in an increase in “driving while high” deaths, for the same study reports that total “traffic fatalities fall by 8–11 percent the first full year after legalization.” 

 

Robert Capodilupo contributed to this blogpost.

Why I Think Conservatives Have the Alfie Evans Case All Wrong

Conservatives are railing against dual decisions by the British government to prevent Alfie Evans’ parents from transporting him to Italy for further treatment, and to order Alfie’s doctors to withdrawal life support from Alfie, which they did, and which soon led to Alfie’s death. Conservatives are claiming this is what you get under socialized medicine: heartless government will override parental rights to pull the plug on your children. My thoughts on Alfie’s case are still tentative, but I think that’s a total misreading. The tragic case of Alfie Evans had almost nothing to do with socialized medicine. 

As hostile as libertarians are to government, even we believe government can legitimately order the withdrawal of life support, and prohibit parents from moving a child to obtain further treatment, when that treatment would fruitlessly prolong a child’s suffering – i.e., when further treatment would be akin to torture. In such cases, the government intervenes to protect the child’s rights. (British law frames the decision in terms of the “best interests” of the child, but it seems to me that language clouds the issue and thereby unnecessarily inflames passions.) 

There is no objectively right place to draw the line between cases in which the government should and should not intervene. But I don’t know anyone who thinks it never should. If anyone does make that argument, they’re just wrong. 

There is plenty of room to argue about whether British law and courts drew the line in the right place here. It did not appear Alfie was suffering, but doctors could not completely rule it out. They all agreed that further treatment was futile, though. Is it torture to provide futile treatment to a kid who likely can’t feel pain?

The only way socialized medicine might have something to do with Alfie’s case is that decades of socialized medicine might have shaped the values and attitudes of the elites who make the ultimate decision about where to draw that line. It is not crazy to think that the incentives the British National Health Service creates to provide less care, and the stiff-upper-lip attitudes that lead Britons to tolerate queues and other forms of explicit and implicit government rationing all for the Greater Good, might influence where the elites draw that line. But if the influence of the NHS leads British elites to be more likely to pull the plug on Alfie, that is not obviously or objectively wrong. 

Nor is it the only way socialized medicine might influence where elites draw the line. The U.S. Medicare program is a system of socialized medicine that imposes no constraints on medical spending or consumption. Decades of experience with it and similar socialized-medicine programs have created a pervasive belief among U.S. physicians and policymakers that more medicine is always better. (Spolier alert: it’s not.) So if U.S. conservatives want to make the argument that decades of socialized medicine have made Britain’s elites too willing to pull the plug on Alfie, they must also confront the possibility that decades of socialized medicine have made them too willing to tolerate the torture of children like Alfie.

I don’t know what the right answer was in Alfie’s case. I do know Alfie’s case is not an illustration of the failures of socialized medicine.

I also know that advocates of socialized medicine have exactly zero right to complain about the ignorance of some opponents of socialized medicine, because socialized medicine also socializes the cost of ignorance.

And I know one more thing: there’s a hug and a pint waiting for Alfie’s parents, Tom and Kate, in Washington, D.C.

The Medicaid Mess

DownsizingGovernment.org has released a new study on Medicaid. The piece discusses basic problems with the program, examines the rapid rise in spending, and proposes reforms to reduce costs and improve quality.

Medicaid is a joint federal-state program that funds medical services and long-term care for people with moderate incomes. It is one of the largest and fastest-growing items in the federal budget, at almost $400 billion a year.

State governments administer Medicaid, but most of the funding comes from the federal government. The current funding structure encourages expansion and provides little incentive to control costs. At the same time, the top-down regulatory structure of Medicaid distorts health care markets. The 2010 Affordable Care Act increased Medicaid spending and did not fix the program’s structural flaws.

Policymakers should reverse course and restructure Medicaid to reduce costs. The program should be turned into a block grant, with the federal government providing a fixed amount of aid to each state. That was the successful approach taken for welfare reform in 1996. Fixed grants would encourage states to restrain spending, combat fraud and abuse, and pursue cost-effective health care solutions.

Federal deficits are rising, and health care spending is a major reason why. Reforming Medicaid with a block grant structure would allow federal policymakers to control spending while encouraging health care innovation in the states.

The DownsizingGovernment.org study is here.

Michael Cannon’s study here is also a good introduction to this costly program.