The Association of American Medical Colleges projects a severe physician shortage by the year 2032, particularly in the primary care fields, as the population of patients as well as doctors continues to age, according to a report today by CNBC.com. AAMC projects the national primary care shortage will range from roughly 47,000 to 122,000.
The news report focused on Arizona, one of the fastest growing states in the union, which has a shortage of primary caregivers in every county. Arizona ranks 44thout of the 50 states in total active primary care providers (PCPs), at 77.9 per 100,000 population (the national average is 91.7 per 100,000) according to a recent report from the University of Arizona.
To deal with the problem efforts are underway in the state to expand residency training programs in order to produce more physicians. But that takes time and money. What is likely to have a more immediate beneficial effect is the state’s recent reform of its occupational licensing laws. Arizona this year became the first state to recognize occupational licenses in good standing granted by other states. This spares new migrants to the state who hold licenses in other states the hardship of repeating costly and time-consuming licensing procedures. As the CNBC report states:
Another way Arizona is hoping to help ease the shortage is by changing licensing laws. Republican Gov. Doug Ducey recently signed a Universal Licensing Recognition law that makes it easier for people licensed in other states to move to Arizona and gain similar accreditation. The measure is the first of its kind in the nation and impacts licensed occupations that range from barbers to physicians. Overall, 30% of occupations require a state-issued license.
This was indeed a good move on the part of the Arizona legislature and Governor and should be replicated in other states. But reforming scope of practice laws so that nurse practitioners, PAs, pharmacists, and other ancillary health care providers can provide services that are now the exclusive domain of people holding doctorate degrees will do even more to improve choice and access to patients in Arizona and across the country. One way to accomplish that would be to move to a system of private certification based upon proven proficiency and skill in a given area. In a recent paper from the Goldwater Institute, one of the co-authors, Murray Feldstein, MD, explains how this would work for health care practitioners:
A certified nurse practitioner, who has a bachelor’s in nursing, an RN license, and a master’s or doctorate in nursing, can do a vasectomy in Washington State. But in most states, that same individual must either fight a scope-of-practice battle in the legislature or go to medical school in order to perform a vasectomy. I am a board-certified urologist who has performed thousands of vasectomies. I am confident I could train an experienced, competent physician’s assistant or nurse practitioner to do the procedure within a few weeks and feel comfortable letting them do it independently.
It would also help for states to reform laws regarding the practice of telemedicine. Most states require telemedicine practitioners to obtain licenses in each state where they make their services available. Ironically, those states don’t prohibit their residents from traveling to the states where those practices are domiciled to receive treatment. Economist and Cato adjunct scholar Shirley Svorny investigated this issue in a Cato Policy Analysis, and suggested solutions. An easy reform would be to redefine the location of the patient-practitioner interaction from that of the patient to that of the practitioner, or for states to allow the practice of telemedicine by health care practitioners licensed by the state in which they are domiciled.
The CNBC report featured comments by AAMC executive vice president Dr. Atul Grover, regarding the shortage. Dr. Grover called for more federal funding of training programs and for medical schools to expand their enrollments. It is unfortunate these other reform proposals were not mentioned.
It has been a rough news day for government-run health care. But not nearly so rough as government-run health care has been to its victims.
First, The Washington Post reports on the matter of Robert Morris Levy, a former pathologist at the Veterans Health Admininstration hospital in Fayetteville, Arkansas who repeatedly showed up for work intoxicated and who "VA officials say...made 3,000 errors or misdiagnoses dating to 2005." Levy showed up for work one day with a blood alcohol level of 0.4 percent, five times Arkansas' legal limit. He misdiagnosed patients who actually had cancer and whose cancers spread untreated for years, leading to their deaths. "Federal prosecutors charged Levy, 53, last week with three counts of involuntary manslaughter in the deaths of three veterans. VA officials now acknowledge that he botched diagnoses of at least 15 patients who later died and 15 others whose health was seriously harmed."
Veteran Kelly Copelin, whose neck and throat cancer went misdiagnosed by a VA hospital for 13 months. Photo credit: Bonnie Jo Mount/Washington Post.
Levy continued to practice at the VHA for 15 years in part because, according to prosecutors, he easily defeated the agency's quality controls for pathologists. While his actual error rate was "nearly 10 percent, more than 10 times the normal frequency of mistakes by pathologists," Levy was able to make his error rate appear to be 0.7 percent or at times zero. So not only did the agency not fire him for showing up to work intoxicated (neither did Arkansas' medical licensing authorities, for that matter), the VHA paid him multiple bonuses atop his $225,000 salary while his lower-income patients endured unnecessary suffering and "horrible" deaths. Your tax dollars at work.
It would have been fairly simple for the VHA to adopt quality-control measures that Levy could not have defeated and that therefore would have identified his errors earlier and saved lives. But the VHA faces insufficient incentives to adopt such measures. It does not operate in a competitive market and neither the agency nor its employees face the same sort of liability for malpractice that private actors do. In a competitive market, these sorts of horrible consequences would damage a company's reputation and cause patients to flee. But the VHA is a near-monopoly government provider with a captive clientele who typically have no other options. As for liability, Cato adjunct scholar Shirley Svorny writes:
The 1946 Federal Tort Claims Act (FTCA) shields government-employed physicians from medical malpractice claims. This includes medical professionals who work for the Department of Veterans Affairs, the Indian Health Service, the Department of Defense, and other federal agencies. The FTCA makes the federal government responsible for defending federal employees when malpractice claims arise, and makes taxpayers liable for harm due to negligence...
Shifting liability for malpractice from physicians to taxpayers shields government physicians from underwriting and oversight by private insurers. Federal agencies, such as the Department of Defense and the Indian Health Service, do often create risk-management programs. Yet government agencies have less of an incentive to reduce the risk of negligent injuries than private malpractice insurers do, because the money at risk in a malpractice suit is a common resource (federal revenues), rather than a privately owned one. Because private malpractice insurers have more at stake in a malpractice suit than government agencies do, the government’s risk-management efforts are likely to be less rigorous. Indeed, federal investigators have found that in some cases, such as community and migrant health centers, the government is ill-equipped to provide risk management. In most cases, consumers would be better off were government agencies not to shield their physicians from malpractice immunity.
As an indication of whether the remaining incentives are enough to prioritize quality and patient safety, the Post reports:
Inspector General Michael Missal’s office in recent years has identified multiple VA physicians who continued to practice even after they were found to have compromised patient care. A report this year by the Government Accountability Office found weak systems for ensuring that problems are quickly addressed when a physician’s quality of care to veterans is compromised.
Veterans thus get hit by a double-whammy. The VHA has insufficient incentive to change -- that is, to save lives -- because killing veterans really doesn't affect the bottom line of the agency or of individual physicians. A single-payer, Medicare-for-All system would subject all Americans to the same double-whammy.
Second, the Post reports on a Journal of the American Medical Association article that alleges the Department of Homeland Security places unethical employment conditions on physicians who treat migrants in the agency's detention facilities. The authors of the JAMA article write:
[P]hysicians and other health professionals are often put into situations in which they cannot fulfil their obligations to their patients because of competing obligations imposed on them by detaining authorities; this is often referred to as the problem of dual loyalty. Given the reports of inhumane, overcrowded, and unsanitary conditions, including insufficient water and toilets, lack of clean clothing and bedding, high exposure to psychological stress, and poor medical care in many of the DHS processing and detention facilities, how can and should needed medical care for detainees be structured, especially given the dual loyalty challenges that emerge if physicians are employed by the agency in charge of detaining migrants?
First and foremost, health care professionals should insist on and adhere to clinical independence to ensure they are able to provide the highest standards of care that are in the best interests of the patient. This independence also demands that physicians and other health care professionals are not subject to retribution for reporting, both in medical charts and openly and transparently to authorities, including legislative oversight bodies, about their evaluations of conditions of detention that impede their patients’ health and the availability of quality medical care. Currently, all DHS employees, consultants, and subcontractors are required to sign nondisclosure agreements that are quite strict and clearly state that if violated, the person “…could be subject to administrative, disciplinary, civil or criminal action…” Such nondisclosure agreements could conflict with physicians’ primary duties to the health of their patients.
In addition, the Post reports, the U.S. Customs and Border Patrol refuses to provide flu shots to detained migrants, even though influenza has been a problem in its facilities and "at least three children died of the disease, according to autopsy reports."
Yet this "dual loyalty" problem is just another manifestation of the same problem we see at the VHA. Each agency has interests that are different from and often conflict with those of their wards. The VHA and the doctors it employs value their patients but they also value stable budgets and job security. DHS, CBP, and their employees value national security but also stable budgets and job security. The main differences are: VHA employees care about their wards, while DHS and CBP employees are openly hostile to theirs; the VHA has a figuratively captive clientele, while DHS and CBP's clientele are literal captives; and yet, even so, the VHA probably does more to harm the health of its clientele. Such is the power of the principal-agent problem that it can overwhelm the agents' intentions to act in the interest of the principals.
The principal-agent problem appears in private-sector health care, too, where the interests of the insurer often conflict with those of the patient. (So does the interest of the physician, for that matter, and not only because of the insurer.) The solution to the principal-agent problem is to let principals (consumers) choose among different agents (health care providers). The resulting competition rewards health care providers who devise the best ways to align their interests with those of consumers. The reason the principal-agent problem is manageable in the markets for haircuts and auto repair is not that those services are less complicated than health care. It is because those markets are markets. In health care, government has defeated the market mechanisms -- principally, consumer choice and competition -- that would otherwise keep the principal-agent problem in check.
There may be some scenarios where consumer choice and competition among health care providers may not work -- for example, when the patient is someone the government is holding captive. Better health care then becomes one more reason why the government should hold fewer people captive.
On August 26 Oklahoma State Judge Thad Balkman ruled that Johnson & Johnson must pay $572 million to the state of Oklahoma for contributing to the local opioid addiction crisis. Johnson & Johnson sold two opioids: a fentanyl skin patch with the brand name Duragesic, and Nucynta,a synthetic opioid similar to tramadol but stronger.
Nucynta is not as addictive as most other synthetic and semi-synthetic opioids and has been shown to have low levels of abuse in post-marketing studies. Fentanyl skin patches are very difficult and inconvenient to convert for non-medical use. The Drug Enforcement Administration claims that nearly all the fentanyl seized is so-called "illicit fentanyl," manufactured mostly in powdered form in clandestine labs in Asia and Mexico, and then smuggled in to the U.S., sometimes via the Postal Service.
Johnson & Johnson was also charged with contributing to the overdose crisis because it owns two subsidiaries that make the active ingredients and narcotic raw materials used by other opioid manufacturers.
Two other opioid manufacturers, Purdue Pharma and Teva Pharmaceuticals, settled with the state, but Johnson & Johnson decided to take the case to trial. Their attorneys say the company plans to appeal the decision.
This is nothing more than a shakedown. As I have written here and here, the government’s own data show no correlation between prescription volume and the non-medical use of opioids or opioid use disorder. In fact, as prescription volume has come down, overdoses have gone up. That’s because as it has become more difficult and expensive to divert prescription pain pills to the underground market for non-medical use, non-medical users have migrated to heroin and fentanyl that the efficient black market is supplying in abundance.
Policymakers and politicians refuse to accept the fact that it is the current policy—drug prohibition—that is the cause of the opioid overdose crisis. Rather than taking a hard look at the dismal failure of America’s longest war, the war on drugs, they just double down on what clearly isn’t working, and seek scapegoats for the death and destruction the war continues to bring.
Oklahoma has extracted some tribute from Purdue Pharma and Teva Pharmaceuticals and, pending appeal, hopes to extract even more from Johnson & Johnson. If enough jurisdictions are successful in getting their piece of the action, we might see drug makers pull out of the pain reliever business altogether. That will not be good for millions of pain sufferers.
While state and municipal coffers may get some quick cash infusions, and some political careers may get a needed boost, this shakedown will not get one IV drug user to pull the needle out of their arm.
A letter to the editor in the August 14 New England Journal of Medicine by researchers at the University of Michigan proudly reported on the results of their effort, called the Michigan Surgical Quality Collaborative (MSQC), to reduce the volume of opioids prescribed for postoperative pain. The Collaborative developed a set of guidelines for its participating prescribers.
As a result, they found that from January 2017 through May 2018, the mean number of pills prescribed for postoperative pain decreased from 26 (+/-2) pills pre-guideline to 18 (+/– 3) pills post-guideline. Patient pill consumption also decreased from an average of 12 pills (+/-1) pre-guideline to 9 pills (+/-2) post-guideline. During that period there was no discernible difference in the pain scores reported by these patients pre-and post-guideline.
It seems all of health care is now fixated on getting the number of prescription pain pills down. Yet there is no correlation between prescription volume and nonmedical use or use disorder/addiction. And as prescription volume has dramatically come down since 2010, the overdose rate has dramatically increased. Furthermore, in 2017 at least 75% of opioid-related overdoses were from heroin or fentanyl, while 40% of overdoses involving prescription opioids had multiple other drugs onboard, including heroin, fentanyl, alcohol, and tranquilizers.
So, as academic physicians continue to virtue signal and show the media and regulators how well they are complying with the "new opiophobia" by reducing opioid prescribing, the overdose rate continues to climb.
To be fair, an oversupply of prescription pain pills to patients can lead to more pills getting diverted into the black market for nonmedical users. But as a doctor who cares about reducing deaths, I would prefer that nonmedical users take diverted prescription opioids as opposed to heroin or fentanyl or counterfeit prescription pills made from fentanyl.
The focus should be on the number of deaths, not the number of pills. For that to happen, policy must to shift to harm reduction.
It seems that no amount of data-driven information can get policymakers to reconsider the hysteria-driven pain prescription policies they continue to put in place.
I can understand lay politicians and members of the press misconstruing addiction and dependency, but there is no excuse when doctors make that error. Yet National Public Radio reports that surgeons in 18 Upstate New York hospitals have agreed on an initiative to limit the amount of pain medicine they will prescribe to postoperative patients discharged from the hospital. The reporter says that researchers “now know” that patients prescribed opioids for postoperative pain “can become addicted” and that “the new prescription guidelines can prevent this particular gateway to abuse.”
But what does the research show? One recent study published in the BMJ of more than 568,000 “opioid naïve” postsurgical patients followed for 8 years found a total “misuse” rate of 0.6 percent. (“Misuse” includes a range of non-prescribed drug use, from self-medicating with leftover pills to treat an ankle sprain on one extreme to addiction on the other.) Broken down further, the researchers found the misuse rate was 0.15 percent in patients given just one prescription postoperatively and was 0.29 percent in patients who got a second prescription as a refill.
Multiple highly-respected Cochrane systematic analyses, the most rigorous reviews in the medical science literature, found the addiction rate in chronic noncancer pain patients on long-term opioid therapy to be around 1 percent.
Addiction and dependency/tolerance are two separate entities, but policymakers and many in the media equate the two. But the doctors in Upstate New York should know better. Physical dependence refers to the physiological adaptation to the drug such that abrupt cessation or tapering off too rapidly can precipitate a withdrawal syndrome, which in some cases can be life-threatening. Tolerance is an aspect of physiological adaptation, in which increasing dose of a medication become necessary to achieve the desired effect. Once a patient is properly tapered off of the drug on which they have become physically dependent, they do not feel a craving or compulsion to return to the drug. Dependence and tolerance are seen with numerous types of drugs, from anti-depressants and anti-epileptics to beta-blockers (used to treat hypertension and other cardiovascular conditions).
Addiction, on the other hand, is defined by the American Society of Addiction Medicine as a “chronic disease of brain reward, motivation, memory and related circuitry…characterized by the inability to consistently abstain, impairment in behavioral control, craving” that continues despite resulting destruction of relationships, economic conditions, and health. Addiction has a biopsychosocial basis with a genetic predisposition and involves neurotransmitters and interactions within reward centers of the brain. Some experts believe addiction is a learning disorder in which behavioral patterns are automatized as mechanisms for coping with stress or trauma. A major feature of addiction is compulsiveness. This compulsiveness is why alcoholics or other drug addicts will return to their substance of abuse even after they have been “detoxed” and despite the fact that they know it will further damage their lives.
Writing in the New England Journal of Medicine in 2016, Drs. Nora Volkow and Thomas McLellan of the National Institute on Drug Abuse explained, “Unlike tolerance and physical dependence, addiction is not a predictable result of opioid prescribing. Addiction occurs in only a small percentage of persons who are exposed to opioids — even among those with preexisting vulnerabilities.”
In 2016 the Centers for Disease Control and Prevention published guidelines regarding opioid prescribing for pain. Many scholars and clinicians specializing in pain management and addiction treatment criticized the guide as lacking a basis in evidence. Despite the fact that the CDC stated its guidelines were meant to be “voluntary rather than prescriptive standards, “ and that much of the guidelines were based on “Type 4 evidence” (defined as “based upon clinical experience and observations, observational studies with important limitations, or randomized clinical trials with several major limitations”), policymakers on the federal and state level have been quick to adopt many of these guidelines as statutory limitations on opioid prescribing. The guidelines recognized that “clinical decision making should be based on a relationship between the clinician and patient, and an understanding of the patient’s clinical situation, functioning, and life context.” But one-size-fits all limitations on prescription dosages and amounts implemented by policymakers are incompatible with that statement.
An outcry from chronic pain patients experiencing the rapid tapering or termination of their chronic opioid treatment that followed in the wake of statutory enactments of the CDC guidelines led former Food and Drug Administration Commissioner Scott Gottlieb to order a meeting on “Patient-Focused Drug Development for Chronic Pain” on July 9, 2018, stating in the meeting announcement: “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 appropriated 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 (emphasis added).” Thus, the Commissioner implied his sympathy with criticisms raised by academic and clinical physicians and their patients regarding the misinterpretation and misapplication of guidelines that lacked a solid basis on the evidence.
Complaints by academicians, clinicians, and the American Medical Association(Resolution 235) finally caused the CDC to issue a clarification in April 2019, noting, “Some policies, practices attributed to the Guideline are inconsistent with its recommendations.” Among the misapplications of the guidelines it noted were those that result in “hard limits or ‘cutting off’ opioids,” stating the “Guideline does not support abrupt tapering or sudden discontinuation of opioids.”
Yet the statutory and regulatory restrictions remain unchanged. To date 18 states have laws limiting the amount of opioids that can be prescribed for acute and chronic pain. Many have limits on the morphine milligram equivalent daily dose (MEDD) that may be prescribed, despite evidence in the peer-review science literature that MEDD is an inaccurate and inappropriate metric. And it appears that even many actively practicing physicians, such as the surgeons in the 18 upstate New York hospitals, ignore the science as well as pleas from patients.
So the march continues, undeterred by the facts, toward a pre-modern approach to the understanding and treatment of pain, and a pre-modern understanding of the risks and benefits of opioids, and the subtleties that differentiate dependency from addiction.
Yesterday the Centers for Disease Control and Prevention reported that while naloxone prescriptions have increased 106 percent in the last year, the increase has been spotty, and largely confined to urban areas. Columbia University epidemiologist Katherine Keyes told the Los Angeles Times that she suspects the increase in naloxone distribution is contributing to what appears to be a stabilization of the opioid-related overdose rate in 2018. I agree, as I have written here.
Distributing the opioid overdose antidote naloxone is one harm reduction measure that has gained widespread acceptance among policy makers, despite a few naysayers who believe making naloxone available presents a moral hazard and may encourage non-medical drug use.
Dr. Anne Schuchat, the CDC Principal Deputy Director, told reporters she also believes naloxone contributed to the stabilization, and that naloxone needs to be more much widely distributed and employed. She told reporters,"If each person with a high-dose opioid prescription were offered naloxone, nearly 9 million prescriptions for naloxone could have been dispensed in 2018."
Last year the Surgeon General issued a Public Health Advisory encouraging Americans to learn more about the drug and to consider carrying the drug with them if they or someone they know use high-dose opioids.
As I have written here, a good way to help accelerate the dissemination of naloxone would be for the Food and Drug Administration to make it truly an over-the-counter drug. In the recent past, the FDA Commissioner seemed very amenable to the idea. It is time to take that next step.
A recently released working paper from the National Bureau of Economic Research by Analisa Packham of Vanderbilt University examined the impact of needle exchange programs (referred to as Syringe Exchange Programs or SEPs) on the incidence of HIV as well as overdose hospitalizations or deaths. The author concluded that the openings of SEPs decrease the rate of new HIV diagnoses by 18.2 percent. But she also pointed to evidence suggesting that they may be associated with an increase in visits to hospital emergency rooms for overdose, and an increase in overdose deaths. The author concluded, “needle exchanges alone may be less effective than other interventions at stimulating recovery.”
This paper was recently cited in National Review as an argument against needle exchange programs. Without having had the chance to study or comment on the study’s methodology, I have a few remarks to make to those who see this as an argument against this proven harm reduction strategy.
- Needle exchange programs are a time-tested, proven method of reducing HIV and hepatitis ever since they were first implemented in this country in the 1980s. The principal goal of the program was to reduce the spread of deadly blood-borne infectious diseases. This latest working paper from the NBER provides yet more evidence of the efficacy of needle exchange programs for the reduction of HIV transmission.
- While many needle exchange programs refer clients to rehab programs, people have to be motivated to enter and stay in such programs. And not all rehab programs are the same. Some, like 12-step abstinence programs, have a high drop out rate. Other programs, like Medication Assisted Treatment, sometimes are more effective, depending upon the degree of social support and adjunctive psychotherapy.
- Not every illicit substance user is an addict in need of “recovery.” Many are recreational users. In fact, many who begin recreational use of illicit drugs after the age of 25 are not addicted, and the majority of illicit drug addicts recover without treatment by the time they reach 30.
- Needle exchange programs were never touted as a means to reduce overdose or overdose deaths—just the spread of disease. However, very recently, many needle exchange programs have started handing out naloxone to their clients to use in the event of an overdose, which still may be problematic if a drug user is alone at the time of overdose.
- This is precisely why Safe Injection Facilities, also known as Safe Consumption Sites or Overdose Prevention Sites, are being promoted in the US. Unfortunately, they are prohibited by federal law—“Crack House Statute”—which prevents several major US cities from establishing them. The Department of Justice is, at this moment, preventing a non-profit group in Philadelphia from opening a “Safehouse” for IV drug users in its Kensington district.
- Safe Injection Facilities work effectively in more than 102 major cities in Europe, Canada, and Australia—since the early 1990s—to reduce overdose deaths precisely because there are people standing close by with naloxone while a drug user injects in a clean and safe environment. Furthermore, the used needle and syringe are collected after each use so they cannot be sold or shared with others out on the street. Recent studies from the University of Pittsburgh and the Canadian Institutes of Health are among the several studies that demonstrate Safe Injection Facilities reduce overdose deaths and save lives. We had a panel on Safe Injection Facilities that featured the program director of North America’s oldest such facility in Vancouver, BC at a harm reduction conference held at the Cato Institute last March. You can view that panel here. The clean, safe, compassionate, and non-judgmental environment these facilities provide is also conducive for referrals to rehab and other social services.
- Harm reduction and addiction recovery are not the same thing. The strategy of harm reduction begins with the understanding that there will never be a drug-free society. It seeks to reduce the harm that results from the non-medical use of licit and illicit drugs. Needle exchange programs were never created for “stimulating recovery," but rather as programs designed to reduce the harm to people who continue to use. It is therefore inappropriate to judge the efficacy of needle exchange programs as a means of attaining recovery.
For these reasons, my immediate reaction to this latest NBER study is to conclude that it found, as did many other studies that preceded it, that needle exchange programs are an effective way to reduce the spread of HIV. It also pointed out the shortcomings of needle exchange programs, which is precisely why harm reduction advocates point to the need to federally decriminalize Safe Injection Sites.
Rather than making the case against needle exchange programs, I find this study augments the argument for Safe Injection Facilities.