“Was OxyContin in fact “central” to the upward trend in opioid-related deaths? Estimates from the National Household Survey on Drug Abuse (now the National Survey on Drug Use and Health) indicate that nonmedical use of prescription pain relievers rose for 11 consecutive years before OxyContin was introduced, and then continued to rise. Even during the period highlighted by Gorsuch, OxyContin never accounted for a very large share of the prescription analgesic market.
Defending itself against all of those lawsuits, Purdue presented Drug Enforcement Administration data indicating that OxyContin accounted for just 3.3 percent of pain pills sold in the United States from 2006 through 2012. After adjusting for potency, ProPublica calculated that the product’s “real” share of the market was more like 16 percent.
ProPublica’s analysis is questionable, assuming the concern is how many opportunities nonmedical users have to get their hands on prescription opioids. But either way, the vast majority of pain reliever prescriptions involved products other than OxyContin, most commonly hydrocodone pills such as Vicodin and oxycodone pills such as Percocet. Those latter two types of products also figured prominently in the pain relievers consumed by nonmedical users, accounting for 75 percent of the total in 2018, according to the federal government’s survey data. OxyContin, by comparison, accounted for 11 percent of nonmedical use that year.”
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“According to a 2007 American Journal of Psychiatry study of OxyContin users admitted to drug treatment programs, 78 percent “reported that the drug had not been prescribed to them for any medical reason.”
Since Gorsuch and Kavanaugh both fault Purdue for contributing to opioid-related deaths by misrepresenting OxyContin as abuse-resistant, it is instructive to consider what happened after the company tried to make good on that promise by reformulating the drug. The new version, introduced in 2010, was much harder to crush for snorting or injection. The idea was to deter nonmedical use, and the hope was that the reformulation would reduce addiction and opioid-related deaths. That is not how things worked out.
The reformulation of OxyContin was instead associated with an increase in deaths involving illicit opioids and, ultimately, an overall increase in fatal drug overdoses. Researchers identified that pattern by looking at the relationship between pre-2010 rates of OxyContin misuse, as measured by surveys, and subsequent overdose trends. They found that death rates rose fastest in states where reformulation would have had the biggest impact.
The root cause of that perverse effect was the substitution that occurred after the old version of OxyContin was retired. Nonmedical users turned to black-market alternatives that were more dangerous because their potency was highly variable and unpredictable—a hazard that was compounded by the emergence of illicit fentanyl as a heroin booster and substitute. Nowadays illicit fentanyl accounts for around 90 percent of opioid-related deaths, which have reached record levels in recent years.
Interventions like the reformulation of OxyContin and the broader crackdown on opioid prescriptions not only failed to turn the tide. They contributed to the upward trend that Gorsuch blames on OxyContin. The story that he and Kavanaugh credulously echo turned out to be deadly as well as misleading.”
https://reason.com/2024/06/27/divided-over-purdue-pharma-deal-scotus-unites-in-accepting-a-dubious-oxycontin-narrative/
“As earlier threatened, the Food and Drug Administration (FDA) has just issued new rules that will significantly slow down the development of new diagnostic tests. Specifically, the agency requires that all laboratory-developed tests (LDTs) be submitted to its regulators before the tests can be offered to patients and physicians. As I explained earlier, LDTs are in vitro diagnostic (IVD) tests for clinical use that are designed, manufactured, and performed by individual laboratories. They can diagnose illnesses and guide treatments by detecting relevant biomarkers in saliva, blood, or tissues; the tests can identify small molecules, proteins, RNA, DNA, cells, and pathogens. For example, some assess the risks of developing Alzheimer’s disease or guide the treatment of breast cancer.”
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” “Laboratory developed testing services are not medical devices and subjecting them to medical device regulation will harm patient access to needed testing and compromise innovations that drive personalized medicine,” said American Clinical Laboratory Association President Susan Van Meter in a statement. “The rule will limit access to scores of critical tests, increase health care costs, and undermine innovation in new diagnostics.””
https://reason.com/2024/04/29/fda-once-again-stands-athwart-biomedical-innovation-yelling-stop/
“During the early stages of the COVID pandemic, the Drug Enforcement Administration (DEA) temporarily lifted restrictions on doctors’ ability to write prescriptions for controlled drugs via telehealth. However, the agency is poised to bring telehealth under regulation again, bringing back strict limits on how and when doctors can prescribe certain drugs.
DEA officials announced the proposed regulations on Friday. The rules would render most controlled drugs ineligible for prescription via telemedicine appointment—severely restricting patients’ ability to obtain drugs without an in-person examination.”
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“However, the proposal contains several carve-outs. Under the policy, Schedule III-V controlled medications can still be prescribed via telemedicine. But patients would be limited to a 30-day supply, after which the patient would be required to have an in-person visit in order to get a refill. The same exception applies to buprenorphine, a drug used to treat opioid substance abuse. Further, under the proposed rule, patients can get indefinite prescriptions for controlled substances via telehealth but only if they are referred to a telehealth physician after receiving an in-person examination by another doctor.”
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“Officials justified the regulations by citing concerns over the risk of overprescription of controlled drugs. While administration officials did mention the benefits that telehealth services bring to rural Americans, there is little consideration of how these services are equally important to many who rely on controlled drugs—and the increased risk that desperate patients will turn to significantly more dangerous drugs to alleviate their symptoms.
“As a health policy lawyer w. chronic pain & ADHD, I cannot overstate how unnecessary & cruel this policy is given what visits look like in person v. Telehealth,” wrote health policy lawyer Madeline T. Morcelle on Twitter. “Or how deadly this could be for those who struggle to get to [appointments] due to disability or transport/geographic barriers.””
“Danny had chronic, searing pain from an electrocution accident years earlier. For treatment, he and Gretchen, his caretaker, traveled regularly from their home in Georgia to a pain management physician in Beverly Hills, California, to receive pharmaceutical fentanyl. But on November 1, DEA agents suspended the Beverly Hills physician’s narcotics prescribing license, having decided that he was inappropriately prescribing painkillers. A week later, Danny and Gretchen killed themselves.”
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“It was the most recent of the many dreadful outcomes that follow when cops practice medicine.”
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“The DEA has not formally charged the physician, David Bockoff, who has been practicing medicine with a spotless record in California for 53 years. He was treating many “pain refugees” like Danny: patients with chronic pain, well-managed with opioids, whose previous physicians had either closed after a DEA visit or abruptly cut off their pain medication fearing the wrath of law enforcement.”
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“Today, 38 states have laws on the books that limit the dosage and amount of pain relievers doctors can prescribe to their patients. Many of these laws have cast in stone the Centers for Disease Control and Prevention’s now-discredited 2016 Guideline for Prescribing Opioids for Chronic Pain. The guideline came under so much criticism from pharmacologists, clinicians, and academic physicians that the agency revised it this past November. No matter. The flawed 2016 guideline remains the basis of the prescribing laws in most states. Doctors face losing their licenses or, worse, jail time if they violate these laws.”
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“All 50 states maintain Prescription Drug Monitoring Programs to surveil all prescriptions issued and filled within the state. These primarily serve as law enforcement tools. In most states, police drug task forces use them to go on warrantless fishing expeditions, hoping to find a doctor to bust for “inappropriate prescribing” or a patient they can arrest for “doctor shopping.” These programs have not reduced the overdose rate. If anything, they have driven non-medical users who cannot obtain diverted prescription pain pills to more dangerous drugs in the black market, causing the overdose rate to increase.”
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“opioid-related overdose deaths reached a record high in 2021, exceeding 71,000, 89 percent of which involved illicit fentanyl. Despite a dramatic drop in opioid prescribing, deaths have soared.
According to government data, addiction to prescription pain relievers has been relatively stable at under one percent in this century. Chronic pain patients rarely become addicted to opioids. The overdose crisis is a prohibition-induced crisis. Neither the practice of medicine nor the act of self-medication belongs in the realm of the criminal legal system.”
“Colorado voters this week passed the broadest reform of psychedelic drug policy ever approved in the United States. With 88 percent of ballots counted as of Wednesday night, 51 percent of voters had said yes to Proposition 122, which decriminalizes noncommercial activities related to the use of “natural medicine” by adults 21 or older. That term covers five psychedelics found in plants or fungi, some or all of which will eventually be available at state-licensed “healing centers.””
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“The initiative defines “natural medicine” to include psilocybin, psilocyn (another psychoactive component of “magic mushrooms”), dimethyltryptamine (DMT, the active ingredient in ayahuasca), ibogaine (a psychedelic derived from the root bark of the iboga tree), and mescaline (the active ingredient in peyote). The covered activities include “growing, cultivating, or processing plants or fungi capable of producing natural medicine for personal use.” The initiative also eliminates civil and criminal penalties for possessing, storing, using, transporting, or obtaining the listed psychedelics or distributing them to adults 21 or older “without remuneration.””
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“The initiative notes that “natural medicines have been used safely for millennia by cultures for healing.” It adds that “an extensive and growing body of research” supports “the efficacy of natural medicines combined with psychotherapy as treatment for depression, anxiety, substance use disorders, end-of-life distress, and other conditions.” But like Oregon’s initiative, Proposition 122 does not require that clients of psychedelic centers have any particular medical or psychiatric diagnosis.”
“Since 2014, state and local governments have filed thousands of lawsuits against pharmaceutical companies they blame for causing the “opioid crisis” by exaggerating the benefits and minimizing the risks of prescription pain medication. The theory underlying these cases is pretty straightforward: Drug manufacturers lied, and people died.
Two recent rulings—one by a California judge, the other by the Oklahoma Supreme Court—show how misleading this widely accepted narrative is. Both decisions recognize that undertreatment of pain is a real problem and that bona fide patients rarely become addicted to prescription opioids, let alone die as a result.”
“On November 4, the United Kingdom’s regulatory authorities approved molnupiravir as a treatment for COVID-19 infections. Meanwhile, the U.S. Food and Drug Administration (FDA) continues to dawdle over approving medications that were so effective that independent Data Monitoring Committees ruled that it would be unethical to continue giving placebos to study participants.
Speaking of dawdling, the FDA has long stymied the development and roll out of another vital component for the effective use of these antiviral medications: namely, at-home COVID-19 testing. Both pills must be taken by people within 3 to 5 days of exposure or symptom onset to be most effective at preventing hospitalization and death. That means that people need to be able to test themselves quickly, easily, and cheaply.
Up until mid-October, the FDA had approved only two over-the-counter at-home COVID-19 diagnostic tests, one of which has now had to be recalled. In the last month and a half, agency regulators have finally gotten around to authorizing nine more.”
“So what do researchers know about the effectiveness of ivermectin, approved for human use but best known as a horse deworming medicine, in treating COVID-19? At the beginning of the pandemic, scientists around the globe began testing thousands of existing medications in test tubes to see if they could be repurposed to fight against the novel coronavirus. In very preliminary research, researchers found that ivermectin significantly inhibited COVID-19 coronaviruses in cell cultures.
Encouraged by these petri dish findings, some desperate clinicians began administering ivermectin to their COVID-19 patients. The result was a number of hopeful observational studies by clinicians reporting that ivermectin appeared to be effective—in some cases, highly effective—in preventing COVID deaths. Observational studies are notoriously subject to researcher biases and confounders that can mislead clinicians into thinking an intervention works when actually a third factor is responsible.
Nevertheless, a prominent group of American physicians calling themselves the Front Line COVID-19 Critical Care Alliance (FLCCC) combined these preliminary observational and epidemiological studies into a November 13, 2020, preprint meta-analysis asserting that ivermectin “has highly potent real-world, anti-viral, and anti-inflammatory properties against SARS-CoV-2 and COVID-19.” Among other findings, the FLCCC pointed to reports that widespread distribution of ivermectin in Peru had correlated with steep declines in COVID-19 cases and mortality there. According to the group, cases and deaths began to rise dramatically in the same country after the government ceased distributing the drug.”
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“research on ivermectin’s efficacy in treating COVID-19 has been ongoing. Has this subsequent research validated Kory’s claim that ivermectin is a miracle drug against COVID-19? It’s complicated, but the answer is largely no.
First: Those dramatic Peruvian results are highly confounded. The steep rise in COVID-19 cases and deaths in that country can most likely be blamed on the breakout of the highly infectious lambda variant rather than to a halt in ivermectin distribution. Meanwhile, the newly reported results of a highly anticipated randomized controlled study of ivermectin in next door Brazil finds that the medicine had “no effect whatsoever” on the disease.
A lot of the hope that ivermectin would be a COVID-19 silver bullet arose from the findings of various meta-analyses, including the one conducted by the FLCCC, that combined the results of various observational studies and small randomized controlled trials. One of the more prominent recent ones was posted as a preprint in May by a team of British public health researchers led by the Newcastle University statistician Andrew Bryant. But other scientists have faulted that study for significant methodological failures.
Also, though it’s not the preprint’s researchers fault, one of the most important studies bolstering their conclusion has been withdrawn because its results appear to be fraudulent. Once the data from that study are removed, the Bryant meta-analysis finds essentially no efficacy for treating COVID-19 with ivermectin.
On July 28, 2021, the authors of a more painstaking meta-analysis of ivermectin COVID-19 treatment studies, published by the Cochrane Library, concluded:
“Based on the current very low‐ to low-certainty evidence, we are uncertain about the efficacy and safety of ivermectin used to treat or prevent COVID‐19. The completed studies are small and few are considered high quality. Several studies are underway that may produce clearer answers in review updates. Overall, the reliable evidence available does not support the use of ivermectin for treatment or prevention of COVID‐19 outside of well‐designed randomized trials.”
The FLCCC folks are surely sincere, but the best evidence suggests that they are sincerely wrong. The bottom line is that while ivermectin might have some marginal efficacy, it is certainly not a “miracle drug” when it comes to treating COVID-19.”
“On Monday afternoon, President Trump told the press that he’s taking a drug called hydroxychloroquine as a preventative to ward off the coronavirus — a practice for which there is no evidence and that could, in theory, have negative side effects as serious as hallucinations and heart failure.
“I take it,” Trump said. “So far, I seem to be okay.”
Hydroxychloroquine is an anti-malarial drug that a non-randomized study from a French lab, publicized in March, initially suggested could be used as a treatment in fighting the coronavirus. In March, Trump frequently touted the drug, calling it “one of the biggest game changers in the history of medicine.” But further studies have concluded that it is not effective in many cases and should not be routinely used to treat patients.
Trump seems to be taking it not as a treatment for Covid-19 — he’s apparently tested negative — but as a preventive measure to protect himself from contracting it. There’s no medical evidence supporting the idea that this would work, and the risk of potential psychiatric and cardiac side effects, which are serious, would likely strongly outweigh any (hypothetical) benefits.
Nevertheless, Trump claims to be taking the drug anyway.”
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“On the one hand, if Trump — a notorious liar — is telling the truth about taking the drug, it’s certainly newsworthy that the president is taking a dangerous medication for no good reason. It would not only speak to his judgment and fitness for office but also suggest a risk to his health and mental competence.
On the other hand, Trump may be trying to goad the media into getting bogged down in an issue that’s less important than the actual outbreak and Trump’s failed response to it. At the press conference, he told reporters, “I was just waiting for your eyes to light up when I said this, when I announced this,” indicating he’s perfectly aware that he’s starting a controversy.”