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Did NIH Waste Almost a Billion Dollars Over 2.5 Years for an Observational Study?
(Thursday, August 10, 2023) In December of 2020, at the height of the Covid pandemic, the US Congress allocated $1.15 billion to NIH to study and find treatments for long-term side effects of Covid, the long Covid. Two and half years later, NIH recently informed the Congress that it has already spent almost a billion dollars of the allocated money for one observational study and assigned the remaining funds for clinical trials to evaluate previously approved drugs for the treatment of long Covid, to the dismay of the scientific community at large. But was it really a waste or diligent use of funds? Long Covid is a debilitating although less defined condition that affects about 65 million Americans. In late 2020, after the US government funded efforts had been successful in creating effective vaccines and drugs to treat Covid, the Congress wanted to think ahead and develop similar treatments for long Covid as it was evident by that time that post-recovery from Covid, many patients complained about lingering adverse effects. However, unlike the Covid infection, the symptoms of long Covid were quite variable. So, it was evident that some basic research would be needed to better understand the disease, find suitable endpoints, and then develop treatments. But it was expected that this would be quick study to control long Covid before it becomes another national emergency. NIH was given the helm of this effort, unlike the Covid vaccine and drug efforts which were primarily conducted by the industry. Perhaps that was the blunder made by the Congress. NIH is not suited for commercial drug development. Rather its strength is in basic research. Although most drug approved by FDA can be linked indirectly to funding from NIH at some point in their development lifecycle, 90% of NIH funding is used for basic research, rather than the development of the drug itself. If the Congress was led to believe that its new funds will be used to develop new drugs for long Covid, it was grossly mistaken, as is evident from the results of that funding. NIH launched an initiative known as RECOVER for its long Covid research and it moved like all its basic research projects. The first task of the initiative was to launch an observational study to review electronic medical records of about 9000 patients to “understand the various symptoms of long Covid”. This observational study was led by a research team at NYU at a cost of $537 million, with support from other groups at Mass General in Boston, Mayo Clinic in Cleveland and several contractors and administrative group at total cost of an additional $421 million, bringing the total cost of the observational study at a whopping $958 million. NIH proudly told the Congress that these efforts have led to 47 scientific publications with another 50 publications in the works. The planned clinical trials under the program would evaluate numerous previously FDA-approved treatments for their use in the treatment and management of long Covid. The first clinical trial to evaluate if Paxlovid, the anti-Covid drug authorized originally by the FDA in late 2020, could be also used to treat long Covid was launched in July 2023, almost two and half years after the launch of the RECOVER initiative. This news has obviously led to a firestorm of criticism for obvious reasons. Practically all of the funds have been spent on observational study at an unreasonably high cost. A total budget of $958 million for data from about 9000 patients translates to more than $100,000 per patient cost for an observational study. And there is strong indication that the study has not given any clinically meaningful data that can be used to treat patients. The program has already run out of funds and no additional funds have been requested or granted, meaning that the only major outcome of this mammoth exercise would be a highly wasteful non-interventional study. The program was run by NIH in a very opaque manner. There were a total of seven announcements by the NIH over two and a half years. The detailed breakdown of the fund distribution has not been published. For example, it would be interesting to audit the justification for the billion-dollar observational study. Patients and research community were not engaged in an impactful manner, treatment options available to long Covid patients were not evaluated effectively, and the clinical trials being launched now seem to ignore available data that casts a negative light on the same treatments based on published reports. There is no way of looking at RECOVER initiative other than seeing as a colossal waste of public funds based on the information available. This could be a case study of why commercial development of treatments can be best done by experts who know how to do that and unfortunately, they are not at NIH. Over the last two and a half years, the industry has launched more than 75 interventional clinical trials to evaluate various treatments for long Covid, compared to none by the RECOVER initiative. Will there be a Congressional study as to how it made a mistake to trust NIH with this program? Why did we wait two and half years to find this out? Will there be a financial audit to investigate how the program funding was designed and justified? What are the lessons from this debacle? All good questions that we should ask our elected leaders. This is certainly a blot on NIH’s reputation as a developer of new treatments for diseases. This was not monopoly money and should not have been spent that way by NIH. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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