3 ms·

But 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

But 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 ago
the 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 ago
  That's what Phase II is for.
SoftTalker 3y ago
Even 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 ago
  The 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 ago
    The 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 ago
  Extending 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 ago
The 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 ago
It'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.

ejb999 3y ago

the 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 ago
That's what Phase II is for.

SoftTalker 3y ago

Even 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 ago
The 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 ago
  The 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 ago
Extending 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 ago

The 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 ago

It'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.