FDA has for Forever Tainted Plasma Treatment for COVID with Bad Politics
[Thursday, August 27, 2020]
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​FDA’s decision this week to formally authorize COVID-19 convalescent plasma (CCP) as a treatment for COVID-19 was 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 Commissioner had to go on an apology tour of the media. It should be noted that CCP has been used since April in the US under an expanded access program (EAP) led by the FDA and Mayo clinic with thousands of patients treated nationwide. The first report from the EAP was published in mid-June where based on data from 5000 patients with severe or life-threatening disease, CCP seemed safe with very modest benefits, if any. The EAP continued and by mid-August about 70,000 patients had been treated with CCP. Looking at how the EAP was run, it seems the researchers had less intention of conducting a formal evaluation of the benefit, and more of just trying to keep collecting data till they had enough to make some claims of benefit, no matter how flimsy. It can be argued that following the first analysis, where data indicated some promising trends, further use of the CCP should have been done with some controls so a proper evaluation of the benefit could be done. It is inexcusable that such a large number of patients were treated, literally blindly. There were other prominent holes in the data like the assays for the antibody titers were non-validated, the treated patients were not tested for their baseline antibody levels which could convolute any estimates of benefit, something that was seen in a study in Netherlands, and the EAP seemingly had a low threshold for including patients leading to a wide variability in response data. If the goal was an emergency authorization by FDA, it could have been done in June, based on the data available at that time, why wait till late August. It should not be surprising that seeing the larger data, top NIH scientists immediately raised red flags over the poor results. But FDA was bent on authorizing the CCP treatment despite the scientific concerns. The approval decision reads like a mishmash of random data clobbered together to make a case in support when it does not exist. Two of the controlled studies, one from China and one from Netherlands, used to justify the authorization, had several issues with data interpretation and did not show benefits. The EAP study had issues as described above. The past data from plasma therapy in other infections was poorly supportive at best. To a qualified reader, the decision seems poorly justified. The timing and tone of the announcement was undoubtedly intended to give political points to the administration. And as far as CCP is concerned, it was already available widely and trusted by physicians, so the authorization will have little impact clinically. The only big loser in this decision is FDA’s credibility. This sets the stage for any vaccine decisions from FDA in the coming months to be mistrusted by the scientific and medical community, particularly if made before the November elections. Would it be too much to hope that FDA stays non-political despite the political pressure it will be under to approve anything before elections?