No surprise here… biomedical research progress is being slowed significantly. This will shorten lifespans for people in the USA, and globally.
Agency is missing deadlines and not responding to biotech companies, forcing some to push back clinical trials
Biotech companies developing drugs for hard-to-treat diseases and other ailments are being forced to push back clinical trials and drug testing in the wake of mass layoffs at the Food and Drug Administration.
For me to agree with this I w have to make the assumption that life saving drugs are being developed. That’s questionable. There have been a few, but near as many as people think. Granted I only work in one specialty, but I don’t use a medication that isn’t at least 10 years old.
I’m sure there are a few good new drugs coming and I trust Dr Makary to expedite those through the FDA process.
That seems incredibly pessimistic, or perhaps your specialty puts very strong blinders on you. In the last 5 years or so, we’ve had the COVID vaccines, bempedoic acid (lifesaving for those who can’t tolerate statins), multiple remarkable immunotherapy and other cancer drugs, the Alzheimer’s immunotherapies, the RSV vaccines, the newer GLP-1 receptor agonists, and better and better therapies for TTR amyloidosis, to name just the ones that immediately come to mind — and the first PCSK9 Inhibitor drugs came to market less than a decade ago. And in the pipeline are obicetrapib, several Lp(a)-lowering drugs, therapies for NASH, and more.
Per the article, trials are getting stuck now for lack of guidance, and the amputations have not ceased.
I use some medications that are <10 years old, but not in the ER as there is no condition I treat there that has a better treatment that what we’ve done for many years. Perhaps the reversal agent for Pradaxa with hemorrhage (Praxbind) - but that is the only one I can think of.
With so many of the drugs that are newly being produced, they have marginal benefits to existing agents, add a lot of cost to the heathcare system and make minimal difference to healthspan or lifespan - especially once looking a costs per quality year of life.
There are exceptions - and those need to be prioritized, but the “me too” drugs need to be limited.
Anyway - I’m not happy personally with rapid funding cuts to important institutions, a gradual approach and watch for adverse items and risks with cutting back as one goes. I suspect there will be some chaos on the way.
Nobody is happy about it, but I remind myself that if the country goes bankrupt, what kind of FDA will we have? That trillion dollars in interest each year will destroy our country.
Right. Which is why, one should probably desist from starting disastrous trade wars with the whole world, which will have bad consequences everywhere, but according to every economic model analysis will have the worst impact on the US both short and long term. The destruction of alliances, alienation of allies and betrayal of the rules based international order might indeed ultimately lead to not just moral bankruptcy (which has already happened: see Ukraine), but economic destruction too. What kind of FDA will we have then, considering the sorry decline we already see in lo, these barely three months of chaos.
However, let’s not jump to conclusions. Let this play out, because there’s a long, long way down, and the collapse has only just begun. There’s plenty further to go, so keep your powder dry, no need to be all out of terms of castigation when so much worse will unfold going forward.
Got you. What I posted then, is non-political to the same degree, whatever the degree may be according to you. In general, I hope we both agree that the “no politics” rule makes eminent sense and is enforced by reciprocity. If I don’t, you don’t, but if you do, it won’t go unanswered👍, Mutual Assured Destruction🤣.
There just might be other ways to lower the budget than NIH budget cuts (and the planned tax cuts that further increase the deficit)…
It’s not obvious why they don’t focus on the biggest parts of the budget (e.g. defense) to make more efficient before targeting smaller budget items like the HHS/NIH:
HHS as a percentage of discretionary budget authority: HHS accounted for 7% of all discretionary budget authority across the government in FY2023.
NIH as a percentage of discretionary health spending: The NIH is one of the key agencies funded by discretionary health spending, accounting for 19% of this spending
One other way to help balance the budget some finance experts are suggesting:
Warren Buffett and Jamie Dimon, two of America’s most prominent financial figures, have called on Washington to increase taxes on the wealthy to address the federal deficit. According to a recent report, the CEOs of Berkshire Hathaway and JP Morgan Chase argue that such a measure is necessary for fairness and fiscal responsibility.
We have a longevity crisis in USA. The best evidence suggests this problem runs much deeper than the obesity epidemic, early drug deaths epidemic etc.
If I were to guess an average american is consuming as much poison as the equivalent of smoking (see endocrine disrupters, microplastics, toxic fertilizer use, food colorings etc). Smoking shortens lives by 10% or so. Solution? We need more food & safety regulation like what you get in Europe. FDA has been playing with lives for the longest time. And the current admin is only making things worse through Doge.
We need more research funding. It’s stupid to be cutting research budgets given fundamental research is the primary enabler of progress.
In short, what’s going on is a disaster. It’s laughable that these people call themselves “make america healthy again”.
I’m an animal lover and strong advocate for the environment and animal rights. But there are targeted use case scenarios where animals are utilized, and I am OK with that. Science is one. Especially medical science. There really is no substitution, no model or silico in vitro approximation will work. Eliminating work with animals is throwing the baby out with the bathwater. Strict rules and ethical guard rails - absolutely. Even eliminating animals from nonessential areas, like cosmetics.
But a complete elimination of the use of research animals will dramatically slow and hobble medical research in the US. Some of it will move to other countries, perhaps with more lax rules around the use of animals and it will be a net loss for animal rights.
I think this is a bad idea, but as I said before: let it play out, there is still a very long way down, a lot more destuction still to come, the show has only just begun. The full horror will only become apparent years down the line, so save your outrage and grief, you will have a great need for it for a long time yet. A leading civilizational power does not die overnight, first there is a long, painful, wrenching decline. Let the historians record, while you, a little grain of sand blown by the winds of history, can at best try to take care of your own needs in the coming storm. YMMV.