Testing products on oneself to demonstrate their potential is as old as science itself. But self-experimentation maximizes concerns regarding the conflict of interest and bias in reported results making any reports anecdotal at best. So, can one use data from self-experiments to support formal additional clinical trials or even market approval? Self-experimentation is not illegal … Read more
A five-year long fraud by one clinical trial company on eight of its clients that was undetected by most till one of the clients got suspicious and complained to the FDA raises concerns about how clinical trials are audited by sponsors. Last month the Department of Justice charged eight individuals in Ohio with several counts … Read more
FDA’s decision this week to formally authorize COVID-19 convalescent plasma (CCP) as a treatment for COVID-19 was almost immediately panned almost universally as a politicized action by FDA. It did not help that the authorization was announced more like a campaign event than a regulatory milestone, with misleading statements, so much so that the FDA … Read more
FDA published a guidance this week about its on-site inspection policies during the pandemic which all but confirms that it is not planning to conduct any foreign on-site inspections and few, if any, domestic on-site inspections, till at least the rest of the year and possible into the first quarter of next year. FDA will … Read more
After years of hesitating to enforce the clinical trial reporting requirements, this week FDA released its guidance on penalties for non-compliance with clinicaltrials.gov posting rule. It satisfies the critics of the non-enforcement but at the same time gives a huge break to the current violators by wiping the slate clean and restarting the clock, in … Read more
While coronavirus vaccines have constantly been in the news, there is little noise about treatments. Vaccines cannot help those who are already infected and seriously ill, so, it should be surprising that there so little news about treatments. In fact, there are about 10 times as many Phase 2 and 3 treatment clinical trials for … Read more
The Russian government made a splash this week by announcing the World’s first approval of a coronavirus vaccine for mass use and, to rub it in, named it “Sputnik V” after the first Soviet satellite that launched the space race. If you set the politics aside and look at the science, the Russian vaccine, if … Read more
A couple of reports this week show disparity in the use of telemedicine in older individuals. Adults older than 72 years of age were found to prefer in-person visits over telemedicine highlighting a hurdle in the expansion of telemedicine. But that’s not necessarily a bad thing. The data can be used to prioritize in-person visits … Read more
We have been told for decades that it takes about 10 years and more than $2 billion to develop a new treatment, so how does one explain that we may have a working vaccine less than 6 months from the start of the first-in-man trials? It may seem like a myth, a conspiracy to deceive … Read more
Celebrity endorsements and testimonials are a prominent way to market a medical product; our media and airways are filled with drug advertisements featuring famous people. But one could use celebrity testimonials to boost the prospects of an investigational product as well. ImmunityBio, Inc., a California company owned by Dr. Patrick Soon-Shiong, treated two celebrities with … Read more
