The FDA Is Approving Drugs Without Evidence They Work
The FDA Is Approving Drugs Without Evidence They Work
Over the last several decades, the Food and Drug Administration has allowed pharma companies to sell hundreds of drugs to patients without adequate evidence that they work and, in many cases, with clear signs that they pose a risk of serious harm.
The article brings up some great points, some of which that I, an industry insider, weren't even aware of, especially the historical context surrounding the AIDS epidemic. I'll jump into the thread to critique an issue within the article.
One of the four pillars recommended by the FDA (control groups) are great in theory but can lead to very real problems in practice, specifically within indications that have an unmet treatment need or are exceptionally rare conditions.
If you have a disease that is 99% fatal but has 0 standard of care treatment options, is it ethical to ask a participant to enroll in a clinical trial and potentially not receive the study treatment/be on placebo? Or, what if the trial involves an incredibly invasive procedure like brain surgery - is it ethical for people to do a placebo procedure? Food for thought - and an explanation for why so few trials meet all four criteria proposed by the FDA.
Happy to answer questions about the industry if anyone has them.
When it comes to therapies that are likely toxic, e.g. chemo, that's why the sponsor has to demonstrate through pre-clinical data that there is a high enough likelihood that the benefits will outweigh the harm that it is a legitimate therapy to trial on humans. Even then there should still be thorough, audited processes for obtaining fully informed consent before recruiting patients into these trials, including making certain they are aware the trial may cause more harm than standard of care.
It's the burden of evidence required in pre-clinical data that makes me defend animal testing despite being vegan.
The consent process for clinical trials has a ton of guidance (ICH GCP), but the onus is on the clinical monitors and hospitals to make sure it's done correctly. Many trials now generate supporting documentation in which hospital staff are required to describe the circumstances in which consent was acquired. If the documents are generated, then it's auditable.
Things get a bit hairy when you look at trials in Alzheimer's and other cognitive disorders, because the patient may not be coherent enough to withdraw from the trial. In those cases, a legal guardian is responsible for the decision.
Unless you actually start looking into the whole of the aids epidemic its easy to miss what an absolute clusterfuck it was. The systems in place weren't prepared at all for it and through a combination of maliciousness, ideological hardheadedness, and novel circumstances more Americans were killed by a virus than by the Viet Cong. But because it hit a group that was already fighting for our rights as well as the fact physicians in high places understood that their duty was not to the public "morality" but to public health things were able to be fought.
Medicine has always relied on killing enough patients to determine how safe/effective or not a drug or procedure might be. We simply do not have the technology to provide definitive answers any other way as of yet. This is why one "practices" medicine and not "does" medicine. And administering a drug to a patient is called a "trial." There is simply no way to know the outcome until the outcome arrives. Years of experience can give you a fair indication of what to expect, but expectations are not definitive answers.
As a keynote speaker ER Doctor stated at an EMS seminar I attended, "No matter how much knowledge and skills we think we know and have, modern medicine still boils down to doing things to keep the patient amused and letting nature take it's course." As a simple medic, that was a thought that stuck with me through my 15 years in the back of the bus. It scared the bejeezus out of me.
Thank you for providing the extra context. That's very helpful.
Not arguing against the substance of the article, but I can’t help but wonder if this is the best way to address this issue. Measles was eradicated from the US but is now back and has claimed lives purely due to vaccine skepticism. I just worry that yet another article criticizing the FDA for pushing drugs that aren’t safe/effective will do more harm than good at this point. Idk, I just sincerely question if now is the time to give americans more reasons not to trust medical professionals. (Again, not arguing with the substance of the article—very disappointing and disturbing that FDA is doing this—but just concerned about the time, manner, and place of this criticism.)
Both can be true.
It can be true that the FDA was corrupted/captured to some extent and needs more 'skeptial' and less-industry-friendly leadership. At the same time, skepticism in science is not the answer.
This is my dillema with MAGA. Many of the issues they tackle are spot on, even if people don't like to hear that. They're often right, even when the proposed solutions are wrong and damaging. I think this a lot when I hear RFK speak, nodding my head at the first assertion then grinding my teeth as he goes on.
This is such an important thing to note. The MAGA set aren't completely oblivious. It's the same issue with how they don't trust "mainstream media," the problem doesn't lie in accepting that media must be viewed with skepticism and critical thinking, the problem lies with the critical thinking ending at "I can't trust the mainstream media."
What the MAGAs are actually practicing is cynicism not skepticism. They have thrown the baby out with the bathwater. Because they have realized some sources aren't always entirely trustworthy, they stop trusting them entirely and instead listen to random jackholes on the internet. It's actually an abdication of critical thinking. Just flat out rejection instead of reading with a critical eye and skeptical mind.
Yeah that’s absolutely how they lure people in. Sensible issues to be concerned about, starts out normal, then about two links of thought in, the tinfoil hats come out and the solution is fucking nuts.
It's tricky. Part of the problem, I think, is if you do have corruption and carelessness in something like the FDA, there's no amount of careful reporting that can fix it - it becomes propaganda.
It's necessary to address the problems, though I still agree with being careful about what information is broadcast and how - but it's necessary to keep information open and challenge things otherwise you end up worse down the line. A measles epidemic is bad. But imagine if you suppressed thalidomide results and other failures, allowing things to get worse and worse in the name of not damaging people's trust, then eventually (after years of covered-up harm) it all comes out and people abandon scientific medicine altogether!
You don't have to imagine... I'm sure a large component of both vaccine skepticism and Trump's presidency have come because of suppressed and partially-suppressed wrongdoing by all the people we think the country should trust. Eventually people break and look for something else.
So, I agree with you, but in my opinion we do need to work more, not less, at transparency and truth even when it's problematic.
and yet puberty blockers should be banned despite being tested with no ill effects for thirty years
the problem with puberty blockers is that they have an explicit and verifiable use case. thats not what drugs are supposed to do! theyre supposed to do whatever you say they do!
American health insurance companies are famously miserly, and this seems like a great area to use penny pinching for good. Where the hell are the insurance CFOs who should be demanding efficacy proof instead of being swindled along with the masses?
They’re busy researching new and exciting ways of denying coverage.
They absolutely do this. A drug with a lack of efficacy data is a great way to get shortlisted to insurance denials
It’s one of the frustrating things bc people can then easily manipulate the issue. A drug that can be prescribed a doctor and filled by a pharmacy being denied by an insurance company is very easy to write about online. Then it’s a slam piece, “x insurance company denied me my meds”. Basically 0 people will have any interest in the nuance that the medication is bullshit or possibly even harmful. Too bad insurance companies made their bed by being absolutely horrible for decades, I guess.
From the article:
While drug companies profit from the sales of unproven drugs, everyone else — patients, insurers, and the government — pays a heavy price. In just four years, from 2018 through 2021, the taxpayer-funded health insurance programs Medicare and Medicaid shelled out $18 billion for drugs approved on the condition that their manufacturers produce confirmatory trials that had yet to be delivered.
I’m guessing their citation only includes Medicare and Medicaid because those have publicly-available data for the study to review, but I have to assume that private insurers pay a ton as well. I can see your point that insurance denials result in angry sick people, but there’s not really a lot of nuance in “that medication has never been shown to be safe and effective for your (or any) condition.”
I dunno. Everyone sucks here.
It is almost as if ...hmmmm...they are working for the very people they regulate? Say it isn't so. 🤔
Sell drug, make money, bribe officials, repeat....Seems like it works fine, for big pharma.
Big Pharma protocol for decades now, with revolving door executives via FDA. What could go wrong?
Yeah, didn't one of 'em dickheads recently say we all have to die somehow... this is just one other way.
Hmmm, now where have I heard this before?...
Since "evidence based medicine" has been a corrupt joke for many decades now, why be surprised now? As long as people continue to claim that real science - which assumes and even demands skepticism and testing and trial and even disagreement as a never-ending process that works for real results and continued improvement - is somehow "anti-science", there is no limit to how whacked "medication" or "treatment" can be or become.
They even got to the FDA? Fuck that…
Always_has_been.jpg
Notably, Phenylephrine was approved in pill form for decongestion, and is all over the place... but doesn't do a damn thing. Trying to keep pseudoephedrine limited in the market to try to fight meth.
THIS is going to Help people TRUST the Government! THANKS Trump!
Unfortunately, this was an issue before Trump and will continue to be one afterwards. Assuming there even is an afterwards...