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With a major pandemic sweeping the world, the standard process of clinical trials for drug approval has come under criticism as a needless source of bureaucracy and delay. Drug discovery chemist Derek Lowe in a blog post explains how clinical trials for drug approval work and the reasons behind the various requirements that the FDA and equivalent organisations around the world generally put in place before approving a new drug. He explains how most of these apparently pointless bureaucratic hurdles are actually there to help protect the integrity of the scientific process and ensure that the human subjects undergoing the trials are treated ethically. While a case can be made for relaxing some of these safeguards, especially in this time of pandemic, it is probably not a good idea to do so without at least understanding what these safeguards are for.
Determining how much of a pharmaceutical is needed to prepare for the trial. Ensuring your are actually preparing just that drug and not a polymorph. Proper laboratory and manufacturing practices to ensure the desired drug is actually prepared without impurities and contaminants. Preparing a plan for a drug trial. Demographics — age, gender, weight, current medications being taken. Getting a representative distribution of these as participants. And there's much more.
(Score: 4, Interesting) by Anonymous Coward on Sunday May 03 2020, @01:26AM (3 children)
Greed is not solely tied to one side of the political spectrum. Big money is a powerful temptation to commit research misconduct regardless of political party.
Dr. Fauci has been promoting the results from one remdesivir clinical trial [statnews.com], saying there's clear-cut evidence that remdesivir works. It would be good to know whether or not he has any financial interest in Gilead. So far, I haven't been able to find this information.
There's good reason to question the results of this clinical trial. There are experimental design of one of the Gilead trials [statnews.com] of remdesivir. Leaked results from a trial in China showedno evidence that remdesivir is beneficial for coronavirus patients [statnews.com]. In the study Dr. Fauci is referencing, the standard for evaluating the efficacy of the drug was changed during the study [washingtonpost.com] from tracking the number of deaths or patients on ventilators to the mean recovery time. While a statistically significant difference was reported in mean recovery time, the difference in the death rate was not statistically significant. Scientists have raised concerns about approving the drug prior to releasing the data from the trial [qz.com] for other scientists to examine. Dr. Fauci chose to release the results early like he did [reuters.com] out of concerns about the results being leaked.
I hope remdesivir really does have efficacy at treating the coronavirus. But there are a lot of trials with questionable methodologies producing conflicting results about drugs like hydroxychloroquine and remdesivir. While some studies claimed that hydroxychloroquine is effective, a large study at the VA suggests it has no benefit in preventing patients from being placed on mechanical ventilators [medrxiv.org]. It's also worth noting that the standard in the VA study of whether patients are placed on mechanical ventilators is different from the standard in the remdesivir study.
My intuition is that Dr. Fauci was just excited about the first study showing a statistically significant positive result versus a placebo for treating the coronavirus. But the question about conflicts of interest is still valid. I'm a researcher in a different field, working in academia. Yesterday, I received a notification that a proposal I submitted a few months ago has been recommended for funding. Before my university processes the award, I'll need to fill out a form disclosing any potential conflicts of interest. And I'll be required to submit a new form every year disclosing any conflicts of interest. Scientists are expected to disclose possible conflicts of interest. Dr. Fauci has been a principal investigators on other awards and didn't have any relevant financial disclosures, but I couldn't find specific information if he has a financial interest with Gilead. Dr. Fauci is a fellow scientist and it's completely fair to ask scientists if they have conflicts of interest.
(Score: 5, Interesting) by Anonymous Coward on Sunday May 03 2020, @02:05AM (1 child)
Has Fauci been "pushing" this drug? I give him a lot of slack given the fine line he has to tread. He has to delicately caveat and temper false hope spouted out of the President, but do it in a way that doesn't embarrass him. Plus he is under tremendous pressure to "wrap all this up" and put a happy spin on everything.
By the way, I work in the Federal Government and every year I have to take an ethics training as well as file a financial disclosure form. Do you know how galling it is under this administration to sit through an ethics course and filling out my disclosure form when our "bosses" flagrantly ignore all of it without ANY repurcussions? It is pretty demoralizing, actually.
(Score: 5, Insightful) by hendrikboom on Sunday May 03 2020, @02:59AM
And that's how a culture of corruption gets established and propagates itself. By demoralizing the honest.
(Score: 1, Interesting) by Anonymous Coward on Sunday May 03 2020, @06:13AM
I've defended the new Remdesivir results. There are key differences in that study compared to many others, but we will have to see the actual preliminary results before anything can really be said. With that out of the way, changing the primary measures happens in studies, especially switch a primary and a secondary. Now, they are correct that this is usually very suspicious because it suggests blinding has been removed or something else fishy is going on, but the preliminary results should give a much better picture of who, when, where, why, and how it was changed.
In addition, there are key differences in this study, according to the public information on it that we have, and ones like the Chinese one in the Lancet. For example, there is a large disparity in group sizes, comorbidity ratios, and other characteristics in the Chinese study that would favor the placebo group. It also had a relatively low statistical power.
To me, this whole thing reeks as the NIAID and the government in general being desperate to come up with something now. The existence of a known mechanism and these preliminary results are an interesting indication that there may actually be something there and is a stark contrast to what came before. When used on patients that aren't nearly as sick, this could be a veritable "miracle drug" such as they can exist. But it is too easy to take shortcuts under political and other pressure. This could just as easily be an ineffective and expensive dud or turn out to net-harm healthier people due to side effects or iatrogenic adverse events.