Buttinskies Get Vapours Over Vapes, Rx Pain Killers

29 Tuesday Oct 2019

Tags

Black Market, Chronic Pain, Debbie Wasserman-Shultz, e-Cigarettes, Opioid Deaths, OxyContin, Paternalism, Prescription Opioids, Prohibitionism, Purdue Pharmaceuticals, Rashida Tlaib, Smoking Cessation, Taxing Harms, Tort Reform, Trump Administration, Vaping

Every now and then I have to grind my axe against reflexive prohibitionism and the misplaced blame for health issues that runs along with it. This time, my outburst is prompted first by a recent study of opioid deaths, and by developments in the vastly less horrifying vaping scare. Both of these issues are like red meat to the busy-bodies of the world, who just can’t stand to sit by knowing that someone might be doing something into which they might affect an heroic intervention.

Pain Is the Price

Pharmaceutical companies have been settling opioid lawsuits brought against them for failing to provide adequate warnings with opioid painkillers about the potential for addiction, for allegedly distributing quantities in areas with “vulnerable” populations, and for other aggressive marketing tactics. Purdue Pharmaceuticals filed for bankruptcy after agreeing to $12 billion in settlements. Many more cases remain for these companies. Settlements, of course, are not admissions of guilt. Rather, they are the least costly way for these companies to extract themselves from situations in which they have been scapegoated by the grieving families of victims, plaintiffs’ attorneys with instincts for deep pockets, and naive reporting by an uninformed news media.

This week came reports of a new study in Massachusetts that found only a small percentage of opioid deaths in which decedents had been prescribed an opioid. According to the researchers:

“The major proximal contributors to opioid-related overdose deaths in Massachusetts during the study period were illicitly made fentanyl and heroin. … The people who died with a prescription opioid like oxycodone in their toxicology screen often don’t have a prescription for it.”

And as Jacob Sullum notes at the last link, this is in line with a number of other studies:

“A 2007 study found that 78 percent of OxyContin users seeking addiction treatment reported that they had never been prescribed the drug for any medical reason. Other studies have found that only a small minority of people treated for pain, ranging from something like 1 percent of post-surgical patients to less than 8 percent of chronic pain patients, become addicted to their medication. A 2015 study of opioid-related deaths in North Carolina found 478 fatalities among 2.2 million residents who were prescribed opioids in 2010, an annual rate of 0.022 percent.”

Most people who become addicted to opioids, and most people who OD, begin their use in pursuit of a high. There are issues over which the pharmaceutical industry can be criticized, but it does not deserve much blame for abuse of the medications it produces. Providing pain medications to health care providers for patients with legitimate needs should not be subject to such severe legal risk. This fraught legal environment has a chilling effect on the willingness of manufacturers to meet those needs, not to mention risk-averse physicians. You, too, are likely to suffer severe pain one day, and your plight will be made worse by these effective prohibitionists.

The Vaping Panic

The dangers of vaping are vastly exaggerated, and the tremendous benefits of vaping for those wishing to quit smoking cigarettes have seemingly been forgotten. Vaping products are far less dangerous than cigarettes, but it matters little to prohibitionists at the federal and state levels. This includes the Trump Administration and such Democrats as Rashida Tlaib and Debbie Wasserman-Shultz, who have jumped on the anti-vaping bandwagon with an opportunistic fervor.

Vaping has increased dramatically among teenagers. Flavored or otherwise, it is likely to have substituted for cigarettes among teens to some extent. Many adult vapers seem to like flavored vaping products as well. As others have noted, a ban on flavored vaping products will make little difference: vapers like the nicotine! And like any form of prohibition, vaping bans will lead to more dangerous varieties of product as buyers turn to the black market for vaping supplies, or simply smoke more cigarettes.

A recent proposal in the House Ways and Means Committee to tax e-cigarettes is also terribly misguided. If we’re going to “nudge” anyone, which in this case is to follow the traditional economic prescription to tax things that harm, then surely we ought to consider where the greater harm lies. Cigarettes are already taxed. Introducing a tax on a relatively new alternative constituting a far lesser harm is sure to have undesirable effects on public health.

Summary

It must be cathartic to identify someone or something to blame for tragedies for which the victims themselves are largely at fault. We know too that the enterprise of bringing legal action against corporate scapegoats is financially rewarding. Unfortunately, those scapegoats can have little confidence in the courts’ ability to reach objective decisions, so they feel compelled to settle with plaintiffs at still great expense. It’s a racket that leads to stunted development of new drugs and under-prescription of painkillers. Tort reform, potentially to include caps on damages and financial risks to plaintiffs attorneys, can mitigate these effects, and it is as important now as ever.

Alarmism over vaping creates risks of a different nature. Vaping is not free of risk, but neither is it a massive threat to public health. It is, in fact, a less harmful alternative than cigarette smoking. Authorities should be cautious in their approach to regulating vapes and e-cigarettes, lest they discourage attractive and safer alternatives to smoking.

Opioids and The War On Pain Treatment

08 Friday Mar 2019

Posted by pnoetx in Prohibition, War On Drugs

≈ 1 Comment

Tags

Annals of Internal Medicine, CATO Institute, Chronic Pain, Dr. Ted Noel, FDA, Fentanyl, Geraldo Rivera, Heroin, Imported Opioids, Jacob Sullum, Jeffrey Miron, Opioid Addiction, Opioid Deaths, Opioid Prescription, Opioid Production Quotas, OxyContin, PDMPs, Portugal Decriminalization, Prescription Drug Monitoring Programs, Prohibition, Purdue Pharma, Scientific American

I repeatedly hear the bogus claim that prescription pain killers are a primary cause of opioid addiction. Twice this week I heard Geraldo Rivera prattling about it, blaming the drug companies for the opioid epidemic, expressing his view of the righteousness of the many lawsuits faced by Purdue Pharma and other firms. But these cases are hardly sure wins for the plaintiffs, and for good reason. The idea that pharmaceutical companies misleadingly promoted the effectiveness of drugs like Oxycontin for pain relief, and minimized their addictive potential, might appear credible, but there are a number of factors that argue strongly against these claims. Of course, opioids are legal prescription drugs, approved for pain relief by the FDA, and are generally marketed by drug companies under guidelines established by the FDA at the time of approval. And sadly, the narrative promoted by Rivera and many others is at tension with the needs of patients suffering from chronic pain.

In fact, opioids are effective for temporary and chronic pain relief, and they have been used for those purposes for many decades. In “The Other Opioid Problem“, anesthesiologist Dr. Ted Noel asserts that few chronic pain patients have overdosed or been killed by ODs. According to Scientific American:

“A Cochrane review of opioid prescribing for chronic pain found that less than one percent of those who were well-screened for drug problems developed new addictions during pain care; a less rigorous, but more recent review put the rate of addiction among people taking opioids for chronic pain at 8-12 percent [but less than 1% abuse].”

Those prescribed opioids for temporary relief after an injury or surgical procedure are even less likely to develop an addiction. The large majority of addicts are self-selected out of a population of individuals who want to get high. And most of them feed their addictions on opioids obtained illegally, often from imported heroin and fentanyl. Yes, opioids are stolen from legitimate patients, pharmacies, or elsewhere, and sometimes they are prescribed illegally by unscrupulous physicians. That might be the way many addicts get started, but most of the illegal opioid supply in the U.S. is imported heroin and fentanyl.

A causal linkage between opioid prescriptions, addiction and opioid deaths would imply a strong, positive correlation between prescription and death rates. However, Jacob Sullum reports that there is no correlation across states between prescription rates and death rates from opioids. As Sullum notes, this result offers “more reason to doubt that pain pill restrictions will save lives”.

In fact, in a separate article, Sullum writes of other evidence strongly suggesting that those restrictions may have counterproductive effects on opioid deaths, in addition to denying some patients access to the pain pills they legitimately need for treatment. According to Sullum, all 50 states have Prescription Drug Monitoring Programs (PDMPs) that monitor controlled substances and keep tabs on prescribers and pharmacies. These have succeeded in discouraging opioid prescriptions, but research appearing in the Annals of Internal Medicine suggests that the programs might be doing more harm than good:

“Fink et al found six studies that included heroin overdoses, half of which reported a statistically significant association between adoption of PDMPs and increases in such incidents. … To the extent that PDMPs succeed in making pain pills harder to obtain, they encourage nonmedical users to seek black-market substitutes. ‘Changes to either the supply or cost of prescription opioids after a PDMP is instituted,’ Fink et al. observe, ‘might reasonably drive opioid-dependent persons to substitute their preferred prescription opioid with heroin or nonpharmaceutical fentanyl.’

The FDA has enforced quotas on the production of legal opioids. According to the CATO Institute:

“The tight quotas on opioid production contributed to the acute shortage of injectable opioids being felt in hospitals across the nation. It is not only making patients suffer needlessly but places them at increased risk for adverse drug reactions or overdose.”

The FDA’s restrictions were eased somewhat after complaints from the medical community, but the harm continues. At the time of CATO’s report, opioid prescriptions had declined by 41% since 2010, while the overdose rate continued to escalate.

This pattern is all too familiar to those who have been arguing against drug prohibition for years. The flood of fentanyl into the country, and into what is sold as street heroin, is a direct consequence of prohibitions on supplies of legal heroin and other narcotics. But breaking through the puritanical and bumptious mentality of drug warriors is almost impossible. The worse the situation gets, the tighter they turn the screws, doubling down on the policies that have repeatedly failed in the past. Here I repeat the concluding paragraph of a Sacred Cow Chips post from January 2018 on the opioid epidemic:

“There are solutions to the deadly nature of the opioid epidemic, but prohibition is not one of them and never will be. If anything, prohibition in varying degrees has aggravated the dangers of opioids. To truly solve the problem, we should eliminate restrictions on the production and distribution of legal opioids for pain management, legalize heroin, and stop interfering in markets. That would be merciful for patients in real pain, make recreational use of opioids dramatically safer, and put an end to the gangland violence associated with underground competition. Second, redirect those resources into … harm reduction programs. [Jeffrey] Miron notes that legalization has worked in other countries, like Portugal and France, to reduce overdoses and opioid deaths. As a political matter, however, these steps might not be feasible unless we get over the cultural bias stigmatizing recreational opioid use as ‘evil’, and the idea that laws and enforcement can actually prevent people from trying to get high.

Prohibition Disaster: Opioid Edition

18 Thursday Jan 2018

Posted by pnoetx in Prohibition

≈ 2 Comments

Tags

Center for Disease Control, DEA Schedule II, Dilaudid, Drug Enforcement Administration, Fentanyl, Heroin, Jeffrey Miron, Jeffrey Singer, Medically-Assisted Treatment, Narcan, Needle Exchange Programs, Notre Dame, Opioid Overdose Deaths, OxyContin, Pill Mills, Prohibition, Safe Injection Rooms, William Halsted

Opioid deaths in the U.S. keep climbing inexorably. However, at the same time, prescriptions for all opioids have decreased for four straight years (2013-2016), according to the Center for Disease Control, and prescriptions for high-dose opioids have decreased for seven straight years (2010-2016). Further decreases are expected when prescriptions are reported for 2017. How does the declining supply square with the increasing death rate? Contrary to popular belief, opioid prescriptions are not now and never were the cause of opioid overdose deaths. The causes are complex, but they have everything to do with ill-fated efforts to regulate prescriptions and prohibit some opioids.

Fatal Fun

In this informative interview, Dr. Jeffrey Singer explains that 75% of opioid deaths occur among “recreational” users who have never obtained a legitimate prescription. The recent increases in overdose deaths have been dominated by “other synthetic opioids” like fentanyl and heroin, both of which are illegal (except for fentanyl in patches or anesthesia). Oddly, heroin is not legal for medical use in the U.S., despite the fact that it is less than half as powerful as Dilaudid, which Singer says is used fairly routinely to relieve severe pain.

Singer debunks a widespread notion about the dynamic underlying opioid deaths:

“…first of all the narrative that everyone has bought into, and this is very frustrating to us practitioners, is that the opioid overdose death problem is a direct result of doctors prescribing pain medicine for patients. So, the popular notion is that I’d write a prescription for an opioid for my patient for pain, my patient becomes a drug addict, and then starts resorting to all sorts of illegal behavior in search of the drug. He becomes a dope fiend, and then he eventually overdoses and dies. … That is not what’s going on.“

From the very beginning, the problem of opioid use was driven by an appetite for recreational drugs. Certainly there are people with legitimate medical needs who develop a dependence or addiction and ultimately turn to the black market for continuing supplies. Dr. Singer does not deny that. But there are also individuals who manage to use these drugs recreationally without ever compromising their lives or livelihoods (see Singer’s anecdote about the “Father of American Surgery”, William Halsted). Unfortunately, however, there are recreational users who become dependent or addicted, just as some do with alcohol.

Where do the opioid supplies come from? Of course, heroin and fentanyl make their way onto the market from overseas, and supplies of prescription opioids also make their way onto the black market. For a real buzz, a lot of oxycodone can be extracted from a OxyContin capsule to bypass its slow release. In fact, illegally-obtained OxyContin became a major source of recreational opioid use following its introduction in the 1990s. At the time, physicians were encouraged to be more aggressive in addressing pain management. But the increase in legitimate use for pain brought a concomitant increase in leakage of pills onto the black market. Rx pads are stolen, a few patients might sell legitimate prescriptions, and pills are stolen from medicine cabinets at parties or over at Grampa’s place, for example.

We’re Watching You, Herr Doktor

Efforts to reduce the availability of opioids have been underway for a number of years now. The DEA has mandated reductions in the quantity of opioids manufactured (25% in 2016 and 20% in 2017). The crackdown on so-called “pill-mills” might have helped stem the flow of opioids to the illegal market, especially in Florida, but the measures included strict supply quotas that have harmed those with legitimate needs for the medications. The DEA reclassified hydrocondone as a Schedule II drug, imposing maximum dosages that are too low to relieve the pain experienced by some patients. All 50 states now have prescription drug monitoring programs (PDMPs), which follow prescribing doctors and patients. Singer says PDMPs have a chilling effect on doctors even when their patients’ needs are legitimate. Finally, the FDA has supported pharmaceutical companies in developing “abuse-deterrent formulations” that can’t be crushed or liquified. And those companies have a strong incentive to do so as they can obtain new patents in the process! Some states have required insurers to cover the new formulations, ending the sale of cheaper generics. That is a nice crony deal for big pharma!

While Endangering Lives

The restrictive policies have led to substitution of heroin for opioid pills, as this Notre Dame study shows. The policies endanger: 1) patients with legitimate needs for pain management; 2) occasional users who are otherwise productive members of society; and 3) heavy recreational users. With greater reliance on black market heroin, there is no way for users to tell exactly what they’re getting: it’s probably impure and it’s often amped with fentanyl, or fentanyl sold as heroin. Fentanyl is 50 times as powerful as morphine and 7 – 8 times as powerful as heroin! Singer describes the severe information problem facing users of black market intoxicants:

“… when I go into the supermarket or liquor store to buy a bottle of liquor and I see on the label it says, let’s say, ’80 proof,’ or ‘15% alcohol,’ the thought never crosses my mind that it may not be that, that it could be adulterated with all sorts of impurities or laced with something that could kill me. I believe what it says on the label, because it’s legal, and in the legal market.

Number one, they have competitors and number two, I have recourse if I’ve been defrauded and injured. But, when were dealing with the illegal market, you go to somebody in a subterranean way who says, ‘Yeah, I have what you want.’ And you don’t know if it’s the dose, you don’t know if it’s pure, that’s what’s happening. In fact, what we’ve learned, because of the narrative that it’s a doctor’s prescribing, since about 2010, 2011, all of the policies of both the federal government and the state governments have been aimed at curtailing the amounts of opioids prescribed.“

Prohibition always creates more danger for users. Adulteration of is one side of it. In “Legalizing Opioids Would Dramatically Reduce Overdose Deaths“, Harvard economist Jeffrey Miron adds that prohibition leads to mixing with other legal or illegal substances:

“In 2013, 77 percent of deaths involving prescription opioids involved mixing with either alcohol or another drug. If opioids are easily accessible, people tend to use the substance they desire; when access is limited, however, some consumers obtain an insufficient quantity and therefore improvise with alcohol, benzodiazepines, and other drugs. Taking these drugs together increases the risk of overdose, especially when dealing with depressants like opioids ….“

Miron and Singer both discuss the risks created by prohibition for users who have developed tolerance to the drugs. Miron says:

“[Tolerance] makes usage less dangerous as the body develops resistance to opioids’ respiratory-depressing effects. … [but] under prohibition users who have developed tolerance get cut off, whether by legal or medical restrictions or by being forced into non-[Medically-Assisted Treatment] treatment. Tolerance then declines, according to medical experts in drug rehabilitation, so users who resume use are more prone to suffer an overdose.

One study proposes that environmental factors also influence tolerance, and that ‘a failure of tolerance should occur if the drug is administered in an environment that has not, in the past, been associated with that drug.’ Therefore, prohibition may increase the chance of overdose by driving users out of their routine into unfamiliar settings in which their tolerance against the respiratory effect of opioids is diminished. “

Finally, by encouraging the development of a black market, prohibition drives up prices, prompting some users to engage in crime to finance their highs. Prohibition itself cedes the market to underworld elements, whose competition culminates in gangsterism and violence.

Medically-Assisted Treatment

Singer believes resources should be redeployed: less drug regulation and interdiction efforts and more harm reduction programs and medically-assisted treatment (MAT):

“… when you take [Methadone] orally, it gets absorbed from the gut. It levels that bind with your opioid receptors enough so you won’t experience withdrawal symptoms. … And the idea behind methadone maintenance is that you get used to not, it’s sort of, behavior modification. You’re blunting withdrawal symptoms, but you’re getting used to not feeling the high. And then it’s hoped that over time, you can be tapered off the methadone. And now you don’t crave the high anymore, and you’re over your addiction problem. That’s the idea behind medical-assisted treatment, whether it’s methadone or Suboxone or others.“

While doctors, within limits, can prescribe drugs to treat pain, they aren’t authorized to prescribe Methadone or Suboxone to treat addiction. But MAT can actually prevent people from dying! In addition, Singer mentions needle exchange programs to prevent the spread of hepatitis and HIV, and safe injection rooms:

“…you go into the room, you inject there, and then you leave. The needle is then discarded by the people who run the place. And not only that, but you have the bonus of somebody being around there with Narcan so if you overdose, because again, you’re using an illegally obtained substance, so you don’t know really what’s in it. … in Switzerland, they reported that teen heroin use has come down, because when the kids see these people going in and out of the clinic to get their injection, it doesn’t look cool.“

Conclusion

There are solutions to the deadly nature of the opioid epidemic, but prohibition is not one of them and never will be. If anything, prohibition in varying degrees has aggravated the dangers of opioids. To truly solve the problem, we should eliminate restrictions on the production and distribution of legal opioids for pain management, legalize heroin, and stop interfering in markets. That would be merciful for patients in real pain, make recreational use of opioids dramatically safer, and put an end to the gangland violence associated with underground competition. Second, redirect those resources into MATs and other harm reduction programs. Miron notes that legalization has worked in other countries, like Portugal and France, to reduce overdoses and opioid deaths. As a political matter, however, these steps might not be feasible unless we get over the cultural bias stigmatizing recreational opioid use as “evil”, and the idea that laws and enforcement can actually prevent people from trying to get high.