Do Hydroxychloroquine and Ivermectin Work?

“A February 2025 review study of ivermectin randomized controlled trials in Annals of Medicine & Surgery concluded that ivermectin showed no significant impact on critical outcomes such as mortality, mechanical ventilation, viral clearance rates, ICU admissions, or hospitalization rates compared to controls. Similarly, a February 2025 review article of randomized controlled trials by a team of Indian pharmaceutical researchers observed that “we consider Ivermectin ineffective in the management of COVID-19 disease, both as treatment and prophylaxis.””

https://reason.com/2025/03/11/do-hydroxychloroquine-and-ivermectin-work/

One More Damned Time: Vaccines Do Not Cause Autism

“Lutnick is right that autism diagnoses have risen substantially. If not childhood vaccinations, what accounts for this increase? First, greater awareness means that many people with autism spectrum disorder who in the past would have been missed by clinicians are now being identified. However, a 2020 review article in Molecular Psychiatry reports that changes in diagnostic criteria “has been accompanied by a 20-fold increase in the reported prevalence of ASD over the last 30 years, reaching a current prevalence of more than 2% in the United States.” This contributes to the likelihood of over-diagnosis and a shift toward autism diagnoses in place of other mental health conditions.”

“the liability system was unable to properly balance the public benefits of vaccines against their private harms. The result of this imbalance was killing off vaccine innovation and production. So Congress a year later chose to change the liability system with respect to vaccines in 1986 with the adoption of the National Childhood Vaccine Injury Act (NCVIA) of 1986 established the National Vaccine Injury Compensation Program (VICP), which provides compensation to people who are injured by certain vaccines.
And the benefits of vaccines are enormous. A 2024 Centers for Disease Control and Prevention review finds that “among children born during 1994–2023, routine childhood vaccinations will have prevented approximately 508 million cases of illness, 32 million hospitalizations, and 1,129,000 deaths, resulting in direct savings of $540 billion and societal savings of $2.7 trillion.””

https://reason.com/2024/11/01/one-more-damned-time-vaccines-do-not-cause-autism/

What you need to know about the new Covid-19 vaccine

“This updated version of the vaccine does not target the now-dominant KP.3.1.1 strain, and instead focuses on that variant’s immediate predecessors, including a strain known as KP.2. That strain was more prevalent when work began on the new formulation; long development times make it difficult for drug makers to pivot to target each new variant.
“Evolution doesn’t stop and let us catch up,” Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, told Vox. “Evolution is always moving, and there’s some unpredictability of where the virus may go.”

Still, scientists believe the new drug will provide the public with at least some increased measure of protection against severe sickness, including against the latest variants. And it could offer some protection against infection since it targets the close relatives of the current dominant variant.”

“The CDC recommends that everyone age 6 months and up get one dose of the new vaccine, regardless of their previous vaccination status, and has stressed the importance of high-risk individuals keeping up with the latest vaccines. Other countries like Canada and the UK recommend that only those with high risk of hospitalization, serious illness, or death from the virus get inoculated.”

https://www.vox.com/public-health/368590/covid-shots-vaccine-mrna-pfizer-biontech-moderna-cvs-flirt-walgreens

Antibiotics are failing. The US has a plan to launch a research renaissance.

“Many other developed countries with established pharmaceutical industries such as Japan, Canada, and the UK have implemented or are working to roll out their own incentives to spur antibiotic development. The Pasteur Act dwarfs these. This could potentially drive pharmaceutical companies to flock to the US market to make drugs deemed important there and not in other places.

“The size of the Pasteur Act is going to be so large that it ultimately draws developers to only focusing on the United States, only developing the drug so that it can be used appropriately in the United States, and only registering the drug in the United States, because that’s ultimately going to be sufficient revenue and incentive for what otherwise is not a very profitable market,” explained Rohit Malpani, a senior policy advisor at the Global Antibiotic Research and Development Partnership, or GARDP.

Cirz added that with a steady influx of Pasteur Act funds, pharmaceutical companies may be less interested in investing additional funds to figure out ways to manufacture their antibiotics more cheaply. Usually companies would continue investing so they can increase their profit margins by lowering manufacturing costs, but if profit margins are set by the US government, then there’s less incentive to make an approved drug cheaper, when it can divert attention to making even more drugs. Without that innovation for affordable production, the act may unintentionally prohibit developing countries such as India from being able to independently manufacture the drug.

Finally, while Americans with federal health insurance plans are guaranteed access to antimicrobials that receive support from the act, the proposed legislation does not provide any stipulations or guidance for ensuring global access to these drugs. Pharmaceutical companies are left to make decisions regarding pricing, manufacturing, and distribution of whatever antibiotics might be funded by the program, argued Ava Alkon, global health advocacy and policy adviser at Doctors Without Borders.

“What the act doesn’t do is attach any meaningful conditions to facilitate affordable access to people outside of those federal programs, and certainly not outside of the US,” said Alkon.

“From our years of work on access issues around the world, this generally results in products being sold to the highest bidder and being inaccessible in many contexts where they’re needed,” she said.”

https://www.vox.com/future-perfect/367247/antibiotic-resistance-bacteria-pasteur-act-big-pharma

Divided Over Purdue Pharma Deal, SCOTUS Unites in Accepting a Dubious OxyContin Narrative

“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.”

“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/

FDA Once Again Stands Athwart Biomedical Innovation, Yelling ‘Stop!’

“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.”

” “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/

Need an Adderall Prescription? Good Luck Getting It Over Telehealth.

“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.”

“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.”

“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.””

After a Crackdown on a Pain Clinic, a Tragic Double Suicide

“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.”

“It was the most recent of the many dreadful outcomes that follow when cops practice medicine.”

“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.”

“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.”

“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.”

“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 Approve Decriminalization of 5 Natural Psychedelics

“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.””

“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.””

“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.”

Two Courts Debunk Widely Accepted Opioid Myths

“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.”