Topic: Health Care

Marijuana Research Catch 22

George Hodgin’s mission seemed simple: manufacture uncontaminated, chemically consistent cannabis for use in scientific research on marijuana’s medical effects, all while complying with federal regulations surrounding the production of a drug still classified by the Drug Enforcement Administration (DEA) as highly dangerous. Despite new rules the DEA promulgated eighteen months ago, with the stated goal of allowing expanded cultivation of marijuana for scientific research, George Hodgin is still in administrative limbo. 

Hodgin, a former Navy SEAL, approached us recently for advice after encountering numerous regulatory roadblocks.  We have no special knowledge or ability in that direction; but perhaps publicizing his endeavors will nudge public opinion (and regulators) in the right direction. 

Expanding research access to high-quality marijuana is important. The Marijuana Policy Project estimates that roughly 2.5 million patients use medical marijuana – just in states with legal medical marijuana programs. This number is likely an underestimate, as it does not account for individuals obtaining marijuana for medical use through non-medical channels. Marijuana’s illegality at the federal level prevents the collection of much needed data that could help drive future research.

Veterans represent a particularly important category of medical marijuana users. Although Veterans Health Administration physicians are prohibited by federal law from recommending medical marijuana, new guidelines issued in December 2017 revise existing standards to encourage doctors and patients to discuss the use of medical marijuana without fear of recrimination. 

The Return of Drug Reimportation?

In his State of the Union address last night, President Trump said that one of his “greatest priorities” is to reduce the price of prescription drugs. “In many other countries,” he said, “these drugs cost far less than what we pay in the United States.” Alluding thus to the “drug reimportation” issue, he added that he had directed his administration “to make fixing the injustice of high drug prices one of our top priorities. Prices will come down.” That won’t be easy.

Back in 2004, when Congress took up the idea of lifting the ban in place on importing lower-priced drugs from abroad, I wrote a long, complex Cato Policy Analysis on the issues at stake, urging, as the subtitle said, “The Free Market Solution.” Unfortunately, three years later, when the Senate finally acted, the bill was anything but a free market solution. In fact, it amounted to importing foreign price controls, as I explained in a piece in the Wall Street Journal. Fortunately, the bill died, but in the face of state efforts along the same lines in 2013, I wrote this time at Cato@Liberty, explaining why the “simple” solution of lifting the ban would not work. Drawing from that post, here’s why, in a nutshell. (See the Policy Analysis for the complex details.)

Given the Food and Drug Administration’s safety and efficacy standards, it takes 12 to 15 years and upwards of a billion dollars to bring a new drug to market, but only pennies a pill to manufacture it thereafter. Obviously, drug companies need strong patent protection or they’d never undertake that research and development.

But when they go to market a new drug, they find a relatively free market only in America. Everywhere else they face socialized medical systems and strict price controls, so they segment markets and price their drugs differentially, garnering such profits as they can from each market. Naturally, therefore, they have to guard against “parallel markets”—vendors in low-price markets reselling the drugs (at a profit) in high-price markets, especially when supply limitations and no-resale contracts are legally suspect. That’s where the reimportation ban comes in. If low-price drugs sold abroad flood the American market, displacing higher-priced domestic drugs, there go the profits—and there goes the R&D needed to discover new drugs.

Naturally, Americans resent having to subsidize the rest of the world, in effect, which is why letting them import cheap drugs from abroad plays so well politically. But we’re faced here with a Hobson’s Choice—which I’ve only sketched in this post. As I said, it’s a complex issue, involving treaty arrangements, patent law, and much more, rooted ultimately in the socialized medical systems we find abroad, toward which, alas, we ourselves are moving. In fact, the ultimate aim of many of the reimportation proponents is to have the federal government subsidize, if not do, the R&D needed to bring new drugs on line. Talk about bad medicine.

Arizona Governor, Legislature, Rush Through Flawed “Emergency” Opioid Legislation

Late on the night of January 25, the Arizona legislature unanimously approved “The Arizona Opioid Epidemic Act,” introduced at the urging of Governor Doug Ducey (R) just 3 days earlier. The Governor and legislature were in such a hurry that they took no time to request testimony from representatives of the medical profession or from any other experts that might have differing views about the best ways to approach the overdose crisis. The overdose crisis is such an “emergency” that there was no time for that. Yet, most of the Act’s provisions are not scheduled to take effect until 2019.

Among the harmful features of the Act are strict restrictions on the amount and dose of opioids doctors can prescribe to new and postoperative patients. Prescriptions may be for only 5 days, and the dosages are capped. Doctors wishing to exceed these limits must first consult a board-certified pain management specialist which, of course, might take several days. This policy is not evidence-based. It will cause injured patients and those recovering from surgery to suffer needless and agonizing pain. In December, the Arizona Medical Association and the Arizona Osteopathic Medical Association wrote the state Department of Health Services warning of harmful “unintended consequences” that may ensue from one-size-fits-all 5-day limits on prescriptions and dosages for patients in acute pain.

This policy is not just inhumane, it’s dangerous. Desperate patients might seek to get better relief for their undertreated pain by supplementing their prescriptions with alcohol and/or other drugs, or by obtaining drugs through the illegal market, increasing the risk of overdose or death.

Another provision requires all providers to use a state-approved E-prescription system to prescribe opioids, placing a burden on health care providers in remote and rural areas of the state, where broadband internet access is inadequate and where some practitioners lack technological sophistication in their practices.

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Medicaid Will Always Trample Someone’s Values

Last week, the federal Centers for Medicare & Medicaid Services (CMS) issued a “guidance letter” that makes it easier for states to exclude abortion providers (chiefly Planned Parenthood) from Medicaid. According to the National Right to Life Committee 19 states have passed laws excluding abortion providers from Medicaid, and such laws are currently in effect in 11 states (Arizona, Arkansas, Iowa, Kansas, Kentucky, Michigan, Oklahoma, South Carolina, Tennessee, Texas, and Wisconsin). The letter does so by rescinding an Obama-era letter that, according to the new letter, “raises legal issues under the Administrative Procedure Act.”

If you support the existence of the Medicaid program, you have no right to complain about states trying to block abortion providers from the program or the Trump administration making it easier for states to do so.

Health care is where people express their deepest-held values, when it comes to both their own care and what they are willing to purchase for others. Medicaid, like all government health care programs, forces everyone to pay for health care in the manner Washington, DC deems appropriate, on pain of prison, whether they like it or not. It therefore turns such personal questions into political ones. It guarantees one side or another’s values will always get trampled. When Democrats run Medicaid, they use it to trample Republican values. They will allow abortion providers to participate in the program, even though many Republicans consider it morally repugnant that the government should force them to subsidize an organization that practices what they consider legalized murder. When Republicans run Medicaid, they use it to trample Democratic values. They will exclude abortion providers, even though Democrats find any kind of discrimination against abortion providers unconscionable. Those who complain about this change are really just complaining that they don’t get to impose their will on other people. 

Congress should instead let Republicans and Democrats keep their money and decide for themselves what health care they will purchase for the disadvantaged.

Stop Calling it an Opioid Crisis—It’s a Heroin and Fentanyl Crisis

The National Center for Health Statistics reported last month that a record 63,600 deaths occurred in 2016 due to overdoses. Digging deeper into that number shows over 20,000 of those deaths were due to the powerful drug fentanyl, more than 15,000 were caused by heroin, and roughly 14,500 were caused by prescription opioids, although it has been known for years that, in most cases of prescription opioid deaths, the victims had multiple other potentiating drugs onboard. The rest of the deaths were due to methamphetamines, cocaine, benzodiazepines, and methadone.

Drugs Involved in U.S. Overdose Deaths* - Among the more than 64,000 drug overdose deaths estimated in 2016, the sharpest increase occurred among deaths related to fentanyl and fentanyl analogs (synthetic opioids) with over 20,000 overdose deaths. Source: CDC WONDER

* Provisional counts for 2016 are based on data available for analysis as of 8/2017.

In its end-of-year report, the National Center for Health Statistics noted deaths from fentanyl increased at a steady annual rate of 18% per year from 1999-2013 and then shot up 88% from 2013-2016.

Fentanyl is not routinely prescribed in the outpatient setting, and when it is, it most commonly is in the form of a skin patch for slow, transdermal release, unsuitable for abuse or nonmedical use. The evidence shows it is being smuggled into the country, often by mail, in powdered form from factories in China and elsewhere, where it is used to fill counterfeit prescription opioid capsules or to lace heroin to enhance its potency.

In the case of heroin, NCHS found the death rate steady from 1999-2005, then it increased 10% per year from 2005-2010, 33% per year from 2010-2014, and has been increasing at a rate of 19% per year since 2014.

Meanwhile, after increasing 13% annually from 1999-2009, the death rate increase from prescription opioids has remained steady at 3% per year since 2009.

For nearly a decade, policymakers have bought into the misguided narrative that the opioid overdose crisis is a result of careless doctors and greedy pharmaceutical companies getting patients hooked on prescription opioids and condemning them to the nightmarish world of drug addiction. As a result, the Drug Enforcement Administration has ordered decreases in prescription opioid production. There was a 25 % reduction in 2017 and a 20% reduction is ordered for 2018. States have set up monitoring programs that put doctors and patients under surveillance leading to a dramatic reduction in the prescription of opioids since 2010. In fact, high-dose prescribing fell 41% since 2010. The popular opioid OxyContin was replaced with an abuse-deterrent formulation in 2010 (that could not be crushed for snorting or dissolved for injecting), and, since then, several other such formulations have come online.

This focus on the supply and prescription of opioids makes many patients needlessly suffer in pain. Some, in desperation, turn to the illicit market to get relief, where they find heroin and heroin-laced fentanyl often cheaper and easier to get. Some resort to suicide.

Policymakers mistakenly focus on doctors treating their patients in pain. By intruding on the patient-doctor relationship they impede physician judgment and increase patient suffering. But another unintended consequence is that, by reducing the amount of prescription opioids that can be diverted to the illicit market, they have driven nonmedical users to heroin and fentanyl, which are cheaper and easier to obtain on the street than prescription opioids, and much more dangerous.

Data from the Centers for Disease Control and Prevention show that from 2006 to 2010 the opioid prescription rate tracked closely with the opioid overdose rate, at roughly 1 overdose for every 13,000 prescriptions. Then, after 2010, when the prescription rate dropped and it became more difficult to divert opioids for nonmedical use, the overdose rate began to climb as nonmedical users switched over to heroin and fentanyl. There is a dramatic negative correlation between prescription rate to overdose rate of -0.99 since 2010.

The overdose rate is not a product of doctors and patients abusing prescription opioids. It is a product of nonmedical users accessing the illicit market.

The problem will not get better—it will probably only get worse—as long as we continue to call this an “opioid crisis.” The title is too nonspecific. This is a crisis caused by drug prohibition—an unintended consequence of nonmedical drug users accessing the black market in drugs. Policymakers should stop harassing doctors and their patients and shift the focus to reforming overall drug policy. A good place to start would be to implement harm reduction measures, such as safe syringe programs, making Medication Assisted Treatments like methadone and suboxone more readily available, and making the opioid antidote naloxone available over-the-counter, so it can be easier for opioid users to obtain. Even better would be a sober reassessment of America’s longest war, the “War on Drugs.”

Renaming the problem a “heroin and fentanyl crisis” might be a way to trigger a refocus.

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ObamaCare’s Greatest Political Vulnerability

In two new posts at the Health Affairs blog, I lift the fog of economic jargon to show ObamaCare’s preexisting-conditions provisions are reducing quality, are wildly unpopular with voters, and are indeed the law’s greatest political vulnerability:

Public opinion surveys show voters support ObamaCare’s preexisting conditions provisions by a two-to-one margin. If those provisions have the effect of reducing quality, however, that initial support flips to two-to-one opposition. The biggest shift is among Democrats, who swing from 82 percent in favor to 55 percent opposed. Voters turn against those provisions whether the erosion in quality comes in the form of less access to medical tests and treatments, longer waits for care, more surprise medical bills, or less access to top-rated treatment centers…

In “Is ObamaCare Harming Quality? (Part 1),” I explain that new research shows that ObamaCare is not working how it is supposed to work in theory: the law’s preexisting conditions provisions create perverse incentives for insurers to reduce the quality of coverage; those provisions are reducing the quality of coverage relative to employer plans; and the erosion in quality is likely to accelerate in the future.

In “How To Ensure Quality Health Coverage (Part 2),” I explain why regulators cannot fix this problem, and why providing sick patients secure access to quality health care requires allowing consumers to purchase health plans not subject to ObamaCare’s preexisting conditions provisions.

Part 2 also explains how expanding the definition of “short-term” health insurance to include policies that include guaranteed-renewability riders, a change the Trump administration can make on its own via regulation, would free consumers from ObamaCare and pressure Democrats to come to the negotiating table.

Washington Post Columnist Needs to Get Her Opioid Facts Right

In a December 28, 2017 column for the Washington Post entitled, “Opioid Abuse in the US Is So Bad It’s Lowering Life Expectancy. Why Hasn’t the Epidemic Hit Other Countries?,” Amanda Erickson succumbs to the false narrative that misdiagnoses the opioid overdose crisis as being primarily a manifestation of doctors over-prescribing opioids, goaded on by greedy, unethical pharmaceutical companies. The National Survey on Drug Use and Health revealed less than 25% of people using opioids for non-medical reasons get them through a prescription. A study reported in the Journal of the American Medical Association found just 13% of overdose victims had chronic pain conditions. Multiple Cochrane analyses show a true addiction (not just dependency) rate of roughly 1% in chronic pain patients on long-term opioids. Yet despite the 41% reduction in the prescription of high-dose opioids since 2010, the overdose rate continues to climb, and for the past few years heroin and fentanyl have been the major causes of death, as death from prescription opioids has stabilized or receded.

In actual fact, the rise in drug abuse and overdose is multifactorial, with socioeconomic and sociocultural components. This helps explain the Washington University study reporting 33% of heroin addicts entering rehab in 2015 started with heroin, as opposed to 8.7% in 2005.

It also helps explain why, contrary to Ms. Erickson’s reporting, opioid overdoses have reached crisis levels in Europe, despite a European medical culture that historically has been stingy with pain medicines, and has encouraged stoicism from patients. And the overdose crisis in Canada, ranked second in the world for per capita opioid use, has alarmed public health authorities there. But at least the Europeans and Canadians have the good sense to emphasize harm reduction measures to address the crisis, such as safe injection rooms and medication-assisted treatment, rather than focusing on inhibiting doctors from helping their patients in pain.

 

 

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