Accelerated approval is intended to get needed drugs to patients, but there are sometimes distortions and complications in the process that should be addressed.
The Lancet reports that a clinical study of different doses of glucocorticoids for managing COVID pneumonia was stopped because treatment led to more deaths. There is power in saying, “We were wrong.”
Advertising of worthless nostrums to prevent or cure illnesses is common. Often, it consists solely of anecdotes, but sometimes it is bolstered by statistical sleight of hand. Don't be fooled, because your health and your money may be in jeopardy.
News organizations have recently been down on Paxlovid, while it has become the standard of care. Some claim Pfizer's Covid drug "has lost its luster" because of "failures" in two clinical trials. Now, a third trial looks like it could deliver another black mark: the drug doesn't improve symptoms in low-risk patients with Covid. Is this criticism valid? Let's look a little deeper.
Antibe Therapeutics is developing a badly-needed new class of anti-inflammatory and analgesic NSAIDs that seem to be much easier on the stomach. The FDA just approved the company's IND for otenaproxesul while the drug has already undergone Phase 2 trials in Canada and is gearing up for Phase 3. Not your typical path for drug development, but whatever works is just fine.
If a standard treatment exists for a medical condition, is it unethical to give patients who are enrolled in a clinical trial a placebo? Most would argue yes, but the ethics become unclear when the standard treatment has its own risks.
We've just gotten a whole bunch of good news – news we really needed – about finally getting the upper hand against COVID-19. Two vaccines, both more than 90% effective at protecting clinical trial participants against the disease, were announced just seven days apart. These numbers are well beyond expectations, but some critically important questions linger. Here they are. The answers will determine how successful the vaccines will be.
Given that more than 200,000 Americans have died (at least in part) due to COVID-19, there seems little to lose and much to gain by green-lighting human challenge trials in which volunteers are vaccinated and then deliberately infected with coronavirus. The U.S. should follow the UK's lead.
Are vaccines going to be adequately tested for safety and efficacy if Phase 3 clinical trials are not completed? Does convalescent plasma work to treat COVID? Is the COVID death toll inflated? We attempt to clarify these controversies.
FDA's Reckless Gamble: Emergency Use of COVID-19 Vaccine Prior to Phase 3 Clinical Trial Completion Is Nuts
FDA Commissioner Stephen Hahn indicated that his agency would be willing to grant emergency authorization to a coronavirus vaccine, even before it completes Phase 3 clinical trials. This is a reckless gamble and could cause an unmitigated public health disaster.
Vladimir Putin and the Kremlin's propaganda machine are working in overdrive.
Most drug and vaccine candidates fail. However, the success rate varies wildly depending on the therapeutic area. The probability that at least one coronavirus vaccine will win FDA approval is quite high, though that does not mean it will work well.