“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.”
…
“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.”
…
“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.”