Health Care

January 20, 2020 11:57AM

Policymakers Obsess Over Pain Prescribing and Ignore the Giant Elephant in the Room: Prohibition

On January 20th, the Cincinnati Enquirer ran a story on the recent report from the Centers for Disease Control and Prevention that showed a 30.1 percent drop in prescription opioid volume from 2010 – 2011 to 2016 – 2017. While the CDC report was non‐​judgmental, it was greeted by hospital administrators and emergency physicians in the Cincinnati area as good news.

The article quotes one physician/​hospital spokesperson as saying:

“The patient can know, ‘My encounter with the ED will … lead to a good outcome. I will not be exposed to unnecessary threats … downstream.’

“They will treat the pain in a safe way.”

I was interviewed for the story and shared with the reporter my experiences as a general surgeon seeing patients referred from emergency departments in excruciating pain who were given minimal pain medication — sometimes just Tylenol (acetaminophen) or ibuprofen — for conditions needing urgent surgical intervention. I told reporter Terry DeMio “It means a lot of people are getting under‐​treated for pain.”

Policymakers, including those in hospital and health care administration, refuse to accept the federal government data showing no correlation between prescription volume and the non‐​medical use of opioids or opioid use disorder among persons aged 12 and over. They ignore the 2018 study of more than 568,000 “opioid‐​naïve” acute pain patients given opioids from 2008 – 2016 that showed a total misuse rate of 0.6 percent, or last November’s study in the Annals of Emergency Medicine that followed “opioid naïve” patients prescribed opioids for acute pain in the emergency department at Albert Einstein College of Medicine and found just one percent still using prescription opioids six months later — and 80 percent of those patients still required the opioids for pain management.

Meanwhile, for the past several years, the overwhelming majority of overdose deaths are due to fentanyl and heroin, and a recent study in Public Health Reports found “prescribed opioids were commonly not detected in toxicology reports” of drug overdose decedents.

It is also important to mention that drugs such as acetaminophen and ibuprofen are not without risk. Acetaminophen can cause liver damage, for example, and ibuprofen can cause kidney damage and gastrointestinal bleeding — unlike prescription opioids.

As I mentioned in a letter to the editor of the Washington Post last December, it is easier for policymakers to focus on the number of pain prescriptions given to patients in pain than to confront the real elephant in the room: the overdose crisis is the result of drug prohibition.

January 2, 2020 1:57PM

The Wall Street Journal Gets It Wrong On Marijuana Prohibition

On December 25, 2019 the Wall Street Journal had an editorial that discussed the involvement of bootleg THC vaping cartridges in the recent outbreak of vaping‐​related lung illnesses. For an editorial board that is usually very sophisticated in understanding and applying economics, I was very disappointed to witness how biases against the recreational use of marijuana and other currently illicit drugs can cloud the usually clear reasoning of the editors. Not only did the editorial cherry‐​pick facts to perpetuate unproven or long‐​discredited dogmas about the harmful effects of marijuana — a drug not nearly as dangerous as alcohol — but it also seemed to ignore the harmful unintended consequences that result from prohibition, which has a lot to do with the “Vaping‐​Marijuana Nexus.” This should never escape the attention of editorialists who are knowledgeable in economics. I was particularly disappointed in light of the editorial board’s history of opposing punitive taxes on tobacco and other politically incorrect but legal products, recognizing that such “sin taxes” only fuel an often‐​dangerous black market. My disappointment and frustration moved me to write this letter to the editor, which the Journal was gracious enough to publish today.

January 2, 2020 9:29AM

With Mounting Evidence That E‑cigs Help Smokers Quit, The Trump Administration is Poised to Make Quitting More Difficult

A just‐​published National Bureau of Economic Research working paper provides empiric evidence that the new “war on vaping” runs at cross‐​purposes with public health efforts aimed at getting tobacco smokers to quit.

Nicotine e‑cigarettes are twice as effective as nicotine patches, gum, or other nicotine replacements in achieving smoking cessation according to a 2019 study published in the New England Journal of Medicine.

In the NBER working paper the researchers studied the impact of the 95 percent tax on the wholesale price of e‑cigarettes that was enacted in Minnesota, the first of the states to tax e‑cigarettes. (There is no federal tax on e‑cigarettes.) They used the National Cancer Institute Tobacco Use Supplement to the Current Population Survey from 1992 – 2015 in conjunction with a synthetic control difference‐​in‐​differences approach and concluded:

Our results suggest that in the sample period about 32,400 additional adult smokers would have quit smoking in Minnesota in the absence of the tax. If this tax were imposed on a national level about 1.8 million smokers would be deterred from quitting in a ten year period. The taxation of e‑cigarettes at the same rate as cigarettes could deter more than 2.75 million smokers nationally from quitting in the same period.

On New Year’s Eve the Washington Post reported the Trump administration plans to announce a ban on flavored vaping pods while sparing refillable open‐​tank systems commonly sold in vaping shops. Menthol and tobacco flavored vaping pods will still be permitted. This is seen as a compromise between a complete ban on flavored vaping and the status quo. President Trump was concerned that a complete ban will irreparably harm vaping retailers.

While this proposal is not as damaging as a complete ban, it still stands to interfere with efforts by adults to quit smoking. Multiple surveys show they prefer the flavored variety to quit tobacco and the flavored pod ban makes that more inconvenient. And if the goal is to reduce teen vaping (which has increased as teen tobacco smoking has plunged), it is unclear if the ban of all flavored pods except menthol and tobacco will have much impact, given survey reports that menthol is one of the most popular flavors among teens.

This proposal will likely cause many teen and adult vapers to shift to the menthol flavor, but it may also cause some to look to the black market for flavored pods, with all of the health risks that entails. It also risks disrupting the continued decline in adult tobacco smoking. 

December 19, 2019 3:02PM

Surprise Medical Bills

By David Kemp and Peter Van Doren

This week the House passed a $1.4 trillion omnibus spending package. As The New York Times noted, the package contains “a giant potpourri of unrelated spending and policy measures stuffed full of priorities with enough appeal to each political party to ensure their passage through Congress and smooth their path to Mr. Trump’s desk.”

Conspicuously missing, however, were provisions addressing surprise healthcare billing, which occurs when patients are unknowingly treated by a physician who is out of their health insurance network and they receive an unexpected, often expensive, bill. Typically, such treatment occurs in emergency situations or when an out‐​of‐​network provider is practicing at an in‐​network hospital. Out‐​of‐​network providers bill patients for the difference between their price and the (usually lower) reimbursement paid by insurance plans.

As recently as last week it seemed a consensus had been reached on how to address the problem, but the provisions were dropped at the last minute from the House bill. The language would have mandated that out‐​of‐​network doctors be paid the median price of in‐​network doctors in the area. For certain large claims, doctors would have been allowed to appeal to an outside arbitrator for reconsideration. A similar process also would have applied to hospitals that treat patients in medical emergencies and to air ambulances (the helicopters and planes that transport patients from remote areas to major hospitals).

The fall issue of Regulation includes two articles on surprise billing that propose different solutions. One endorses mandatory arbitration of surprise charges as the most neutral market‐​oriented solution. Unlike the dropped provision, this solution would not impose a rate for physicians’ services. Instead, in cases in which in‐​network reimbursement rates differed from out‐​of‐​network provider charges, patients would be responsible only for the usual in‐​network charge and the decision over whether the provider payment request or the insurer network reimbursement would prevail would be made by an independent arbitrator.

A second recommends a contract‐​based alternative in which in‐​network hospitals become responsible for resolving surprise billing by providers who work at the hospitals. This solution would require all providers at a hospital to contract with the same insurers as the hospital or to secure payment for their services from the hospital, which would bundle these payments in the in‐​network facility fees they charge insurers. This would incentivize hospitals to directly address the problem of surprise billing because if they did not the costs would fall on them. This is consistent with economic theory that recommends placing burdens on those that face the lowest transaction costs to resolve disputes.

The primary difference between these two proposals is their understanding of the root cause of surprise billing. Are surprise bills the natural outcome of failed negotiations between insurers and providers? Then an independent dispute resolution process replaces patients as the final backstop in negotiations. Or are surprise bills a symptom of a flawed system in which bad‐​faith actors set artificially high prices? The second solution requires hospitals to resolve the problem contractually or be responsible for the surprise bills.

Despite these different perspectives, both proposals are superior to the proposed Congressional solution, which would have imposed prices through policy. Whatever solution is eventually agreed upon, lawmakers should resist the temptation to specify the appropriate price in legislation.

December 18, 2019 5:52PM

Some Thoughts about the Ruckus over the Ohio Abortion Bill

There has been major pushback from many Ob/​Gyn specialists, reacting to a bill introduced in the Ohio State House of Representatives in late November, HB 413, that would outlaw abortion in almost all circumstances. Much of the pushback from the medical profession centers around Section 2904.35 of the more than 700‐​page bill. The section would exempt physicians from prosecution for “abortion murder” or “aggravated abortion murder” for actions leading to the death of a fetus if they:

(A) Using reasonable medical judgment, believe[] it is highly probable that the pregnant woman will die from a certain fatal condition before her unborn child is viable;
(B) Perform[] a surgery, before the unborn child is viable, for the sole purpose of treating the pregnant woman’s fatal condition;
(C) Take[] all possible steps to preserve the life of the unborn child, while preserving the life of the woman. Such steps include, if applicable, attempting to reimplant an ectopic pregnancy into the woman’s uterus.

Many doctors are particularly incensed over subsection (C), which discusses reimplanting the ectopic pregnancy into the uterus. Medical experts have vigorously complained that there is no such procedure. Ob/​Gyn specialist Daniel Grossman of the University of California San Francisco went so far as to call the treatment, initially mentioned in an earlier version of the bill, as “science fiction.” A twitter storm has erupted over this section of the bill. Dr. David Hackney, a Cleveland obstetrician, tweeted:

The new Ohio HB413, p.184: To avoid criminal charges, including murder, for abortion, a physician must “…[attempt to] reimplant an ectopic pregnancy into the women’s uterus” I don’t believe I’m typing this again but, that’s impossible. We’ll all be going to jail.

To be fair, Dr. Hackney is not accurately quoting the legislation. The bill does not state a “physician must attempt to reimplant” the ectopic pregnancy (my emphasis added). Rather, the language states that physicians are exempt from prosecution if they attempt to reimplant the pregnancy “if applicable.” Because medical science has not yet figured out how to reimplant the pregnancy, it is not applicable. At least not yet.

Physicians rightly object when uninformed or misinformed legislators intrude on the practice of medicine and the patient‐​doctor relationship. But legislation such as this also creates medical ethics and medicolegal dilemmas, regardless of where one stands on the abortion issue.

The doctrine of informed consent has been a pillar of medical ethics for almost 100 years, spurred by Mary Schloendorff, who won her case against New York Hospital in 1914 after having a hysterectomy performed on her without her consent. Judge Benjamin Cardozo stated in his ruling on that case:

Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent, commits an assault, for which he is liable in damages.

Under the doctrine of informed consent, as a general surgeon, it is unethical — and in almost all states it is illegal — for me to treat or perform a procedure on a patient to which they do not give consent. For example, I cannot perform a lifesaving operation or give a lifesaving blood transfusion to a patient against their will. I can’t even remove a normal appendix from a patient after successfully removing a diseased gallbladder without that patient’s informed consent. An Ob/​Gyn doctor cannot perform a lifesaving operation for ectopic pregnancy if the woman does not grant permission.

For the sake of argument, assume medical science develops a means of reimplanting an ectopic pregnancy into the uterus. And assume all doctors who treat ectopic pregnancy feel competent in performing reimplantation and believe it to be a safe and effective procedure. As with any procedure, it would not be risk‐​free. If a doctor must obtain informed consent to operate for the life‐​threatening ectopic pregnancy, must consent also be obtained for the second operation — the reimplantation? Beyond medical ethics concerns, does a law requiring reimplantation in this situation conflict with existing informed consent law?

One can argue that the law only pertains to the punishment of doctors who fail to perform reimplantation, and that a doctor can refuse to perform the lifesaving ectopic pregnancy operation unless the patient consents to reimplantation. If the patient refuses reimplantation, the doctor is faced with letting the patient die or violating the law and risking a murder charge. And the patient must either consent to reimplantation or risk exsanguinating from a ruptured ectopic pregnancy.

Patient and doctor both have a Hobson’s choice here. The autonomy of both comes under attack.

This is just one of many unforeseen issues that arise when lawmakers try to micromanage the practice of medicine and the patient‐​doctor relationship.

December 13, 2019 1:59PM

A Ban on Flavored E‑Cigs Will Put Adolescents in Greater Danger

As of December 2019, eight states have acted to ban the sale of flavored e‑cigarettes. Other states are contemplating bans in 2020.

I have pointed out here and here why banning flavored vaping products will deny adult tobacco smokers a proven means of quitting harmful tobacco smoking.

In fact, nicotine e‑cigarettes — of which more than 90 percent of adult tobacco quitters prefer the flavored kind — are twice as effective as nicotine gum or patches in helping smokers stop. We recently learned from the Centers for Disease Control and Prevention that virtually every case of EVALI (e‑cigarette or vaping product‐​use associated lung injury) is due to bootleg THC vaping cartridges containing vitamin E acetate.

The states of Washington and Colorado, where recreational cannabis is legal, banned the use of vitamin E acetate in the manufacture of any THC vaping cartridges by state‐​based companies in reaction to the CDC report.

It has been illegal to sell e‑cigarettes to persons under age 18 since 2016. The reason lawmakers are targeting flavored vaping products is because underage e‑cigarette users prefer the flavored variety. But, as mentioned above, so do adults trying to quit tobacco.

Now comes a new study published in the December issue of the peer‐​reviewed journal Addictive Behaviors Reports that found 80 percent of adolescents aged 13 – 17 who were able to obtain JUUL brand e‑cigarettes got them from “at least one social source (e.g. ‘someone bought for me, someone offered me’) in the past 30 days.” The rest were able to buy them, usually at convenience stores or gas stations.

Keep in mind, JUUL brand e‑cigarettes, the most popular brand on the market, are legally produced and do not contain vitamin E or THC (which is federally prohibited).

The many arguments against a panic‐​driven ban on flavored e‑cigarettes resonated with US Senator Ron Johnson (R‑Wisconsin), who sent a letter, co‐​signed by several other senators, urging President Trump against going through with his plans to implement a federal ban on flavored vaping products. The letter appeared to help. The President backed off from his plan in late November.

In announcing the change, President Trump said, “If you don’t give it [flavored vaping cartridges] to them, it’s going to come here illegally.” He’s correct.

There is already evidence that the Mexican drug cartels are getting into the vaping cartridge business. Now with this new evidence of the ease with which teens are able get safer and legally produced e‑cigarettes through “social sources,” it is easy to see how dangerous, tainted, products smuggled along the cartel routes will quickly fill the void created by a flavored vaping ban.

State lawmakers should restrain the impulse to “do something” in reaction to a largely media‐​driven panic that ignores the abundant evidence.

December 11, 2019 10:32AM

Scientific Studies as “Click Bait?”

A study published last week in the Journal of the American Medical Association reported on an association between e‑cigarette use and depression. The cross‐​sectional study of nearly 900,000 e‑cigarette users who self‐​reported into the Behavioral Risk Factor Surveillance System from 2016 to 2017 found that users had a higher likelihood of reporting a history of depression, and that incrementally higher frequency e‑cigarette use was associated with an incrementally higher likelihood of reporting depression.

The authors mention that several earlier studies showed an association between tobacco smoking and depression, but there are few studies looking at an association between e‑cigarettes and depression. Regarding the meaning of their findings, the authors stated:

These findings highlight the need for longitudinal studies to examine the association between e‑cigarette use and depression, which may be bidirectional.

And in their conclusions, the authors note “the need for prospective studies analyzing the longitudinal risk of depression with e‑cigarette use.”

Correlation does not imply causation. And the fact that nicotine delivered in liquid vaping cartridges carries an association with depression among its users similar to that known to exist with nicotine delivered in combustible tobacco cigarette smoke should not come as earthshaking news.

At first blush, one is moved to ask what the researchers were trying to accomplish. The authors admit that any association between e‑cigarette use and depression “may be bidirectional.” Indeed. A Duke University study in 2006 found nicotine may decrease depression in nonsmokers, and many studies show nicotine has a calming effect, and aids in cognition. It has even been found to benefit patients with Parkinson’s Disease.

It is fair to say that this study provides no real useful information. True, if, as the authors recommend, a longitudinal prospective study was performed, it might help with the question of causation, because it can then be determined which came first — the nicotine use or the depression. But even then, underlying characteristics may be causes of both depression and a demand for nicotine. And nicotine use may be a way to self‐​medicate for depressive symptoms but may still display first. 

So why, then, was this study published? I am reminded of the influence that public policy and media narratives have on modern science. This led Stanford University Professor John Ioannidis to discover in 2005 “Why Most Published Research Papers Are False.” It is the subject of a new book, “Scientocracy,” to be discussed at a Cato Book Forum on December 17. (Full disclosure: I wrote a chapter in the book.) As I have written here, sometimes confirmation bias and politics influence which studies get published. If the study appears to add fuel to media‐​driven panic — in this case, the media‐​driven panic surrounding e‑cigarettes — it stands a good chance of getting published. It seems these days as if even peer‐​reviewed academic journals are succumbing to the tabloid journalist dictum: “If it bleeds it leads.”