WASHINGTON — The National Institutes of Health on Friday announced it would launch a sweeping public-private partnership between federal researchers and 16 pharmaceutical companies, aimed at coordinating and accelerating the development of Covid-19 treatments and vaccines.
The partnership, to be known as Accelerating Covid-19 Therapeutic Interventions and Vaccines, or ACTIV, is meant to standardize research between the federally funded researchers and a broad array of drug companies, and prioritize research into drugs and vaccines that are having high near-term potential.
“Now is the time to come together with unassailable objectivity to swiftly advance the development of the most promising vaccine and therapeutic candidates that can help end the COVID-19 global pandemic,” Francis Collins, the NIH director, said in a statement.
The new collaboration will focus on standardizing the methods and models that researchers are using to test promising Covid-19 compounds. It will also provide researchers access to high-level laboratory facilities and standardize endpoints to ensure different companies and researchers are judging potential medicines by the same criteria. Finally, it would establish one joint control arm to be shared among all clinical trials, the NIH said in a press release.
The partnership will establish a system to precisely coordinate clinical trials to make sure all trials have adequate capacity and can tailor their populations to “different populations and disease stages.”
It will also create a steering committee to effectively determine which drugs should be prioritized for further research and which drugs should be deprioritized — effectively, to cull the group of over 100 potential treatments and vaccines, keeping only the most promising.
The announcement comes as drug companies and government researchers around the world scramble to develop cures and vaccines to fight the Covid-19 pandemic, which has killed roughly 145,000 people worldwide and 33,000 in the U.S. alone.
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NIH, the federal government’s roughly $39 biomedical research agency, has already played a prominent role. Tony Fauci, who leads the National Institute of Allergy and Infectious Diseases — an institute within NIH — has emerged as a key adviser within the Trump administration’s coronavirus response.
The National Heart, Lung, and Blood Institute, another institute within NIH, last week launched research projects measuring the efficacy of hydroxychloroquine, the antimalarial drug that President Trump has touted as a promising coronavirus treatment. Last week, NIAID and a trio of other institutes announced a separate study aimed at measuring the true rate of coronavirus infection in the U.S. by measuring the number of adults who have coronavirus antibodies but have not displayed symptoms.
Trump made his first visit to the NIH’s campus last month.
The 16 drug companies involved are: AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Evotec, GlaxoSmithKline, Johnson & Johnson, KSQ Therapeutics, Eli Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, Takeda, and Vir Biotechnology.
The partnership will be orchestrated by the Foundation for the NIH, an intermediary that facilitates partnerships between private companies and federal researchers. Some of those partnerships have been scrutinized in recent years. The NIH in 2017 was forced to cancel a partnership with the National Football League aimed at researching concussions, and in 2018 canceled a partnership with beverage manufacturers regarding alcohol’s health impacts, citing undue industry restrictions or influence in both instances. The same year, the NIH declined roughly $200 million in funding from drug manufacturers for opioid addiction research, citing the potential for perceived ethical problems.
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Why leave out Leronlimab by CytoDyn? It is one of the most promising treatments out there! That makes absolutely no sense, but perhaps they are better off.
Better late than never. Standardization of trials should have occured a month ago. Tens of thousands of trial patient’s data are completely unusable for determining safety or efficacy because of poor trial design. Had trial standardization occured in March would would already be seeing the efficacy and safety data.
My thinking is NIH should standardize and take over the process of Trials completely of the pharma companies. Reasons for that are
1. Trials are the most expensive part of drug discovery. Small companies which can come up with new innovative drugs cannot play because of trial costs
2. NIH can use its vast resources in standardizing and optimizing the trial process to bring the cost down significantly as it can have permanent relationships with university hospitals. Most of the University researchers have relationship with NIH for research funding
3. As one agency is running the trials it will also streamline the FDA approval process and there is third party viewing the results
The main idea of the partnership is to give access to highly sophisticated labs that INH has, there are only few of them like level 4 labs. This may or may not be good idea as the private companies will have access to the virus for testing, which can speed up the process of developing a vaccine or drug. I am more of the opinion to focus our resources on finding a treatment or cure for COVID19 rather than a vaccine. Vaccines are long term projects. We need a drug to treat it so we can go back to where we were and avoid great depression.
I do agree it should be available to all companies not just the big few. You never know where the talent might be that will provide a therapeutic option. However, most of the small companies do not have enough trained personnel.
I don’t think china has the brain power to come up with therapeutic option. Their CDC guide recommend any drug or combination of drugs can be used to treat COVID19, including some Chinese herbal medicine. Here we are already debating different options and doing trials on virtually anything. I think (may be biased) US has made much more progress in knowing about this virus in the last four weeks, than the whole world since Nov last year.
So – the NIH selected only Big Pharma with deep pockets promoted by brash Lobbyists. What else is new? Although the effort and goals are laudable, it is not collective enough as it excludes promising fast-acting smaller companies like Mesoblast, BioCryst, Inovio, Novavax, Dynavax. Big Money is at work again, for obscene profits later. The short-sightedness at government level is shocking as it also still carries corruptability.
I agree with Peter B. This collaboration will narrow, not widen, the window of innovation and reeks of conflict. So sad our leaders cannot think out of the box when we desperately need them too.
My concern is the ulimate price point for patients. A couple of the firms listed in the partnership are notorious for price gouging. One in particular jacked up the price of insulin to $1,300 for a 30 day supply. If the taxpayers subsidize the research and development on the front end, why is the retail pricing still in the stratosphere?
kaf
As a complete layman playing catch up, I have no idea if this is a good thing or not. One has the fear the big guys may be establishing control over an extremely lucrative industry. I mean no offense to anyone and do not assume that is what is going on, but can someone with more knowledge comment?
Truthfully, I do not know anything about this.
I do strongly believe the cautions built into the system are very likely to be doing us harm now, rather than helping us.
From what I can glean, for example, IF, instead of testing an experimental vaccine on say 50 people around Seattle, they tested it on say 1,000 or 2,000 – some very large number of people – then you have 20 to 40 times as many people at risk – sounds very reckless and irresponsible – but you probably get back, within a few months, a lot more important data .
We are told the 50 people test will probably only tell us if the vaccine is harmful in itself.
We are also told, if they test a very large number of people, (especially in a hotspot) that we would soon know two very important things, A. Does the vaccine work to prevent the disease? B. Does the vaccine make the disease worse? (Antibody Dependent Enhancement or some other unintended consequence)
I realize the dangers are real, and it is a lot easier to suggest people take the risk if you are not the person getting injected by the vaccine which might kill them (or doing the injecting, and taking the risk of blaming yourself or being blamed if things go wrong)
BUT WE NEED THE DATA SOONER RATHER THAN LATER.
I fear having the doctors, who of course have been raised on “First, do no harm” in charge is the makings of a continued disaster which will go on for about a year longer than necessary, by the end of which, the US will be gutted out, with a vastly greater death toll AND economic devastation – and the complete world dominance of China, which will either get a vaccine a lot sooner – this seems almost certain to me – or use extremely strict sanitary measures to get their economy running again in the meantime.
Just following up my own Comment- obviously no one disputes the value of being “active” about getting therapies and vaccines out ASAP.
But I do not understand why there is a need for partnership with NIH. Shouldn’t the NIH be ORDERING the drug companies what to do, when it’s staff, consulting with outside experts, determines what that is?
The stated goal of ensuring there are enough test subjects for, presumably, every study favored by this group, “The partnership will establish a system to precisely coordinate clinical trials to ensure all trials have adequate capacity…”
seems odd to a layman who is reading of 2,000 deaths and 2,000 new infections per day with no end in sight – if we are so short of test subjects that we need to ration them out, maybe the pandemic is over and we don’t need this new group at all? How can that be a problem?
I am just asking questions, please someone inform me.
Mr. White – please realize that your dominating frequency and lengthy thoughts / reflections may very well result in others un-subscribing from STAT news – an unfortunate but expectable reaction to your overkill.