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We sometimes have posts here from patients who are desperate. And everyone dumps on the FDA in those threads. This is the flip side of that. This was patients
by light_hue_1 3y ago
We sometimes have posts here from patients who are desperate. And everyone dumps on the FDA in those threads.
This is the flip side of that.
This was patients lobbying Congress to skip safeguards. The FDA did not want to do this. https://apnews.com/article/science-business-health-lobbying-congress-08f90cb109edd90fd7dd94d608960a05 https://apnews.com/article/science-business-health-lobbying-...
Now it's just getting worse and worse. ALS patient communities used the questionable approval of Aduhelm by desperate Alzheimer’s patients to strongarm the FDA into approving this. Every junk pharma product is now going to come with an advocacy group that says "let's just try it and see".
Grifter pharma corporations will of course take advantage of this. They'll mobilize patient communities to keep skipping the science. And the result will be more wasted lives and more misallocated resources. Instead of working toward drugs that help people, we'll be working toward drugs that sound good to patient communities and Congress. This is a disaster.
The FDA might be slow. But it's slow and deliberate for a reason.
- rafaelero 3y agoBut what's the harm here? The drug is safe. The only burden patients had was financial. Now what if the drug was effective? The harm it would incur to patients by delaying it would be much more extreme.
- ejb999 3y agothe harm is not all drugs are safe - even if this one was (and we aren't 100% sure of that either), and pharma companies using social media and/or sympathy stories to pressure regulators into approving a drug that would not otherwise get approved is gross.
- rafaelero 3y agoThat's what Phase II is for.
- SoftTalker 3y agoEven if it's safe, the harm is in rewarding drug companies for producing very expensive products that don't work, and selling them to desperate people and their families who will sell off everything they own and go as far into debt as they can to pay for them. This creates incentives that we don't or should not want.
- rafaelero 3y agoThe FDA could impose a ceiling over the price the company is allowed to charge if they are in a situation where there is reasonable expectation of efficacy but the trials haven't been consistent. Would that appease your concerns?
- light_hue_1 3y agoThe FDA could not impose a ceiling on the price being charged. The FDA literally has no authority to set the price of anything. This comes up so often it's actually an FAQ on the FDA website. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/frequently-asked-questions-about-cder#:~:text=However%2C%20the%20FDA%20has%20no,of%20competition%20in%20the%20marketplace https://www.fda.gov/about-fda/center-drug-evaluation-and-res.... > We understand that high drug prices have a direct impact on patients—too many American patients are priced out of the medicines they need. However, the FDA has no legal authority to investigate or control the prices set by manufacturers, distributors and retailers.
- JoshuaRogers 3y agoExtending this further, the belief that a competitor has an effective drug gaining traction in the market while you are still at an unpromising point in research could reasonably lead companies to focus their research elsewhere. After all, your costs don’t go down for research if a competitor is already delivering, but your likely returns do drop.
- bsder 3y agoThe harm here is the medical industry sticking with the amyloid hypothesis in the face of repeated and expensive failures. The funding needs to move on to something that might actually work. Propping up these failed drugs with "what does it hurt" is in the way of getting an Alzheimer's drug that might actually benefit people.
- pcwalton 3y agoIt's a ton of wasted money. We should spend limited resources on treatments that actually work. I feel tremendously for patients and their loved ones frustrated with the FDA's sluggishness, but results like these illustrate why it's needed. Especially since many of the drugs have much worse side effects than this one.
- ethanbond 3y agoIt’s extremely hard for people to look past the current environment of, in general, knowing that whatever drug they can get their hands on (commercially) is going to at least be safe and probably quite effective.
- GenerWork 3y agoMy hot take is that if you have a disease like ALS that's pretty much always fatal, you should be able to skip whatever safeguards the FDA has setup as long as you're informed that this medicine could hurt you or even kill you before the disease does.
- arrosenberg 3y agoIts a nice sentiment, but it ends with desperate families spending all their savings on an ayahuasca-carrot juice cleanse to try and save their loved one. Still need some kind of process to weed out the grifts.
- firejake308 3y agoIs it wrong for desperate patients to spend all their savings on ayahuasca-carrot juice? I don't think it's very ethical of the juice seller to exploit patients by selling them hope, but it doesn't feel like it should be illegal, since the patient does get some value out of the purchase, even if it's just (false) hope
- qotgalaxy 3y ago[dead]
- shawnz 3y agoWhat if for example they get conned into spending their life savings on fake treatments that exist today and then have nothing left when a promising legitimate treatment is developed six months from now? And what about their heirs? What if they get conned into wasting away wealth that they could have passed down based on a false idea that it could help them be cured? Not to mention that it hurts society as a whole to allow money to flow to grifters whether or not the subjects of the con successfully get false hope out of it.
- arrosenberg 3y agoYes, it is unequivocally wrong for us to allow desperate people to get scammed. I almost can't believe I have to say that, but I've been on the internet long enough to know better.
- starky 3y agoImagining the perspective of someone with ALS I can see why they rightly would be advocating for a quicker process even with the risk. Most people diagnosed with ALS die within 1-5 years depending on how quickly it progresses. They don't have the benefit of waiting on the normal timeline for FDA approvals. The downsides of taking an experimental drug that harms them or just doesn't work is likely worth it for someone in that situation when they look at the potential upsides if it does work. For quickly degenerative diseases maybe we need a different process that takes into account the context of what the drug is used for and what the acceptable risk is by the regulatory bodies. Making the standards and process clear will help provide the framework to reject those with unreasonable demands.
- SoftTalker 3y agoThe other approach is simply accepting one's fate. No, there isn't some cure just around the corner with the only roadblock being FDA approval. There just isn't. There are cancer treatments with terrible side effects but they are approved because they have measurable efficacy. There are no ALS drugs because none of them work. Wishing hard doesn't change that.
- thenerdhead 3y agoThe FDA is not that slow though. People misinterpret that it is actually the trials that are slow. Many things get approved quickly for as large of an enterprise as the FDA.