Topic: Health Care

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.

New York Times Succumbs to The False Narrative Driving Opioid Policy-and Deaths

In an April 21 editorial, the New York Times succumbs to the false narrative reverberating in the media echo chamber that blames the opioid overdose crisis on doctors overprescribing opioids to their patients in pain. Even worse, the Times perpetuates a significant component of that narrative: the myth that such overprescribing can essentially be traced to nothing more than a single letter to the editor by researchers at Boston University in the New England Journal of Medicine in 1980 touting the low addictive potential of opioids when prescribed in the medical setting. 

In fact, numerous studies before and after that now “infamous” letter continue to demonstrate the low addictive potential of medically prescribed opioids. For example, 2010 and 2012 Cochrane systematic analyses show chronic non-cancer pain patients on opioids have a roughly 1 percent addiction rate, and a January 2018 study by researchers at Harvard and Johns Hopkins of more than 568,000 “opioid naïve” patients over 8 years who were given opioids for acute postoperative pain showed a total “misuse” rate of 0.6 percent. In a 2016 New England Journal of Medicine article, Dr. Nora Volkow, the Director of the National Institute on Drug Abuse, stated, “Addiction occurs in only a small percentage of patients exposed to opioids—even those with preexisting vulnerabilities.” Furthermore, researchers at the University of North Carolina followed 2.2 million North Carolina residents prescribed opioids in 2015 and found an overdose rate of just 0.022 percent—and 61 percent of those overdoses involved multiple other drugs.

The Times then offers the same restrictive strategy—only more so— that is doomed to fail because it is based upon a false premise. The editors even suggest that opioids should be restricted to terminal cancer patients. Look at where this approach has gotten us thus far.

The prescription of opioids to patients peaked in 2010, with high-dose prescriptions down 41 percent since that time. A report last week from IQVIA showed opioid prescriptions dropped 10 percent in the last year, and high-dose prescriptions dropped 16 percent. The Drug Enforcement Administration ordered a 25 percent reduction in opioid production in 2017 and another 20 percent reduction this year. And since 2010, OxyContin has only been available in an abuse-deterrent form and many other opioids are likewise being reformulated. 

Yet the overdose rate continues to climb, and the majority of overdoses are due to fentanyl and heroin while the overdose rate from prescription opioids has stabilized or even slightly receded. The great majority of overdoses involve multiple drugs. In New York City in 2016, 75 percent of overdoses were from heroin or fentanyl and 97 percent of overdoses involved multiple drugs—46 percent of the time it was cocaine.

The opioid overdose crisis has always been primarily a manifestation of nonmedical users accessing drugs in a dangerous black market caused by drug prohibition. 

Policymakers must disabuse themselves of the false narrative they continue to embrace. It is the driving force behind a policy that has returned us to the “opioiphobia” of the Nixon era. It is making patients needlessly suffer and increasing the death rate by driving nonmedical users to more dangerous and deadly alternatives.

 

 

 

Government Encourages Third-Party Payment, Which Drives Health Care Prices Higher

Cato adjunct scholars Charlie Silver and David Hyman have an important oped in today’s Houston Chronicle explaining how third-party payment increases prices for drugs and other medical goods and services. An excerpt:

If you’re like us, your health insurance coverage includes a prescription drug benefit. The benefit isn’t free, but you’re willing to pay for it because it saves you money every time you have a prescription filled. You are responsible for your co-pay, and your insurer pays the rest.

At least, that’s how it is supposed to work. But the truth is that your insurer often pays nothing. Your co-pay is all the pharmacy receives. Not only that, but your co-pay often exceeds the amount that someone without insurance would have paid for the drug. That’s right: People who don’t have insurance are paying less than you are for the same drug…

The scam works by taking advantage of consumers’ naive belief that their insurers are watching out for them. Suppose you have high blood pressure and your doctor prescribes amlodipine, a medication used by millions. If you have insurance, you probably think your insurer negotiated a great deal because a month’s supply at the pharmacy costs you only $10. But if you paid cash for the same drug at Costco, you’d have to pay only $1.85…

The real problem is that insurance is a terrible way of paying for things that we can and should pay for directly. Price-gouging does not happen with drugs that are sold over-the-counter at retail outlets like CVS, Costco or Wal-Mart. Those prices are transparent and easy to compare. When people pay directly for drugs, there are no hidden transfers between pharmacies and PBMs either. Competition does for cash customers what PBMs and pharmacies don’t seem able to do for one in four of the prescriptions filled by insured customers — reduce drug prices to the lowest sustainable level.

Overcharges occur throughout the rest of our health care system too, and they drive up the cost of all sorts of procedures. Why? Because insurers don’t care about costs nearly as much as patients do. If we want to get health care spending under control, we should pay for it directly as often as we can.

Read the whole thing.