Topic: Health Care

Coming Soon to a Los Angeles Times Corrections Box Near You

Correction: The article “Trump’s New Insurance Rules Are Panned by Nearly Every Healthcare Group that Submitted Formal Comments” claimed the Trump administration proposes allowing short-term health insurance plans “to turn away sick people.” In fact, federal law already allows short-term plans to turn away sick people, and to our knowledge not even opponents of the administration’s actual proposal have proposed changing that feature. We regret the error.

The article claimed the Trump administration’s short-term plans proposal would weaken consumer protections. In fact, the proposal would strengthen consumer protections by allowing short-term plans to shield enrollees who fall ill from medical underwriting—a consumer protection the Obama administration prohibited these plans from offering. We regret the error.

The article described groups that advocate forced health care subsidies as “patient and consumer advocates,” but withheld that designation from patient and consumer advocates who oppose forced health care subsidies. We regret allowing ideology to creep into our reporting.

Finally (we hope), the article identified the financial interests of groups supporting the Trump administration’s proposals, but not the financial interests of groups opposing them. We regret our failure to follow the money.

The AMA Gets it Right by Defending Evidence-Based Medicine and Patient, Physician Autonomy

Gun control advocates like to accuse legislators of being “afraid of the NRA,” implying that reason and principle have nothing to do with their legislative decisions. In the same way, Jackie Kucinich, in a column in The Daily Beast, suggests that the failure of Congress to pass CARA 2.0 (Comprehensive Addiction and Recovery Act) is due primarily to the lobbying clout of the American Medical Association, pointing to its status as the “seventh highest lobbying spender in 2017.”  

The article quotes opioid reform advocate Gary Mendell as saying “the AMA will resist anything that regulates healthcare”—an interesting opinion about an organization that supported passage of the Affordable Care Act, one of the deepest regulatory intrusions into American health care in half a century. Over the years, the AMA’s seeming reluctance to mount a principled defense of patient autonomy and freedom of choice in healthcare—perhaps fearing it may jeopardize the cartel it lobbied so hard to establish over the past century and a half—has led to an exodus of many disillusioned members. It is estimated that less than 17 percent of the country’s doctors belong to the special interest group today.

But on this one, the AMA gets it right. It opposes the “one-size-fits-all” imposition of the 2016 opioid prescribing guidelines issued by the Centers for Disease Control and Prevention; guidelines that many noted addiction medicine specialists have criticized as not-evidence based. The AMA maintains the CDC expressly meant for its guidelines to be suggestive “rather than prescriptive.” Other scholars have pointed out that the CDC’s suggestions were based upon “Type 4 evidence,” defined as evidence in which “one has very little confidence in the effect estimate, and the true effect is likely to be substantially different from the estimate of the effect.”  The AMA emphasizes the guideline’s statement, “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.”

When health care providers read and interpret these guidelines, they understand them to be informational, nonbinding, and inconclusive. But that’s not how politicians “do science.”

There is no evidence that prescription limits reduce overdose deaths. In fact, as the prescription rate has dropped dramatically since its peak in 2010, overdose rates are in turn rising

Kucinich seems to agree with the politicians who interpret the CDC guidelines as implying that a more than 3-day supply of prescription opioids is a major force behind addiction. But that is not a precise and critical reading of the guidelines. In fact, as Dr. Nora Volkow, Director of the National Institute on Drug Abuse pointed out in a 2016 New England Journal of Medicine article, “Addiction occurs in only a small percentage of persons who are exposed to opioids — even among those with preexisting vulnerabilities.” Cochrane systematic studies in 2010 and 2012 show a roughly 1 percent incidence of addiction in chronic non-cancer pain patients, and a January 2018 study of 568,000 “opioid naïve” patients given prescriptions for acute post-surgical pain found a “total misuse” rate of 0.6 percent. 

The AMA is actually a little late to the party. Numerous other specialists in the management of pain and addiction have criticized for months the tendency of politicians to codify the recommendations of the CDC. Even the Food and Drug Administration Commissioner, Scott Gottlieb, has expressed concerns. Announcing plans to hold a public meeting on July 9 on “Patient-Focused Drug Development for Chronic Pain,” Dr. Gottlieb set forth “the goal of providing standards that could inform the development of evidence based guidelines.”  

The article quotes Sen. Joe Manchin (D-WV) accusing his colleagues of being “too scared to take on the AMA.” My hope is that they may be finally responding to evidence and accounts from health care practitioners and patients who have spent months appealing to reason over dogma.

HHS Can and Should Allow Short-Term Plans to Protect the Sick from Medical Underwriting

If you aren’t paying attention to the debate over short-term health insurance plans, you should. It’s a mixed-up, muddled-up, shook-up world where Republicans are pushing to expand consumer protections, Democrats are fighting to block them, and the public debate has it exactly backward.

In this morning’s Wall Street Journal, I explain:

ObamaCare premiums keep skyrocketing. Rate hikes as high as 91% will hit many consumers just before Election Day. Maryland insurance commissioner Al Redmer warns ObamaCare is in “a death spiral.”

So-called short-term health plans, exempt from ObamaCare’s extensive regulations, are providing relief. Such plans often cost 70% less, offer a broader choice of providers, and free consumers to enroll anytime and purchase only the coverage they need.

But there’s a downside. When enrollees fall ill, either their premiums spike or they lose coverage, leaving an expensive ObamaCare plan as the only alternative. Markets solved that problem decades ago via “renewal guarantees,” which allow enrollees who get sick to keep paying the same premiums as healthy enrollees.

For more than two decades, Congress has consistently tried to prevent sick patients from being to medical underwriting. Yet in 2016, the Obama administration did exactly the opposite. It issued a regulation that exposed enrollees in short-term plans to medical underwriting after they got sick:

In 2016, in an effort to force people into ObamaCare plans, the Obama HHS shortened the maximum duration for short-term plans from a year to three months and banned renewal guarantees. The National Association of Insurance Commissioners complained this reduced consumer protections and exposed the sick to greater risk, including the risk of having no coverage.

The Trump administration has proposed reversing the Obama rule and allowing short-term plans to offer both 12-month terms and renewal guarantees that allow enrollees who get sick to keep paying the same premiums as healthy enrollees (i.e., no more underwriting). Both of these proposals are consumer protections that would protect the sick from medical underwriting and in some cases protect the sick from losing coverage entirely. 

Believe it or not, Democrats are opposing these consumer protections! I am tempted to say their opposition is inexplicable, but it’s all-too explicable. Democrats want to prevent short-term plans from offering these consumer protections because they fear consumers will find short-term plans more attractive than ObamaCare. Democrats are literally trying to stop Republicans from expanding consumer protections because they would rather protect ObamaCare. 

While Politicians Cut Opioid Prescriptions, Fentanyl—With Help From the “Dark Web” and the USPS— Becomes the Number One Killer

A May 22 story in Bloomberg News describes with painstaking detail the underground pipeline through which the powerful synthetic opioid fentanyl floods the US market. According to the Drug Enforcement Administration, while the Mexican cartel plays a role by using its well-established heroin and methamphetamine distribution networks, most of the fentanyl comes in to the US from China. 

The raw materials to make the synthetic opioids are cheap and they can be manufactured rather quickly in small laboratories. The laboratories are constantly creating new variations so as to skirt restrictions the Chinese government places on existing fentanyl analogs. Online distributors throughout China sell these products, making their transactions over the “dark web,” often paid with cryptocurrency, and frequently ship the products to the US via the US Postal Service or United Parcel Service. 

Many dealers purchase and use pill presses to make counterfeit OxyContin or Vicodin pills and trick non-medical users into thinking they are buying the real thing. That’s how Prince died. He preferred to abuse Vicodin (hydrocodone). Records show he never got prescriptions from doctors. He died from ingesting counterfeit Vicodin pills he obtained on the black market that turned out to be fentanyl.

The DEA reports this is the way most fentanyl makes its way to the street. As we doctors know, most pharmaceutical-grade fentanyl made for medical use does not get diverted on to the streets. In fact, the forms usually prescribed to outpatients—skin patches, lozenges, buccal films—are not very suitable for non-medical use.

The Centers for Disease Control and Prevention reports that fentanyl was responsible for 26,000 overdose deaths in 2017. But already in 2016 fentanyl accounted for more than 20,000 of the roughly 64,000 total overdose deaths (which include cocaine, methamphetamine, and benzodiazepines). Heroin came in second with more than 15,000. In fact, for a few years now, fentanyl and heroin have accounted for the majority of overdose deaths. And a great majority of those deaths had multiple other drugs on board. In New York City in 2016, three-quarters of overdose deaths were from fentanyl and heroin, and 97 percent of overdoses had multiple other drugs on board—46 percent of the time it was cocaine.

Fentanyl overdoses in the US have been rising at a rate of 88 percent per year since 2013. Heroin overdoses have been increasing at a rate of 19 percent per year since 2014 after climbing 33 percent per year from 2010-2014. Meanwhile, overdose deaths from prescription-type opioids have been increasing at a stable rate of 3 percent per year since 2009.

The National Survey on Drug Use and Health reports non-medical use of prescription opioids peaked in 2012, and total prescription opioid use in 2014 was lower than in 2012. And the survey repeatedly reports less than 25 percent of non-medical users see a doctor in order to get a prescription. Three-quarters obtain their drugs through a friend or family member or a drug dealer.

Meanwhile, while all this is going on, policymakers in Washington and in state capitals seem intent on getting the opioid prescription rate down further. State-based prescription drug monitoring programs have succeeded in reducing the prescription of high-dose opioids by over 41 percent since 2010, the peak year of opioid prescribing. And opioid production quotas, set by the DEA, were reduced 25 percent last year and another 20 percent this year, generating acute shortages of injectables in hospitals across the nation that is harming patients.

With all the evidence that the majority of non-medical users are not patients—with all the evidence that prescription rates have come down while overdose rates keep going up—with all the evidence of fentanyl and heroin flooding the black market and causing those deaths, it is time for policymakers to disabuse themselves of the false narrative to which they’ve been stubbornly clinging. This narrative blames the overdose problem on doctors prescribing pain relievers to their patients. The overdose problem has always been primarily caused by non-medical users accessing drugs in the dangerous black market created by drug prohibition. And our current restrictive policy is only driving up the death rate by pushing these users to more dangerous drugs while making patients suffer in the process.

What’s the definition of insanity?

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.