Personally I think there should just be a waiver if you're willing to risk side effects. I agree It's great that the FDA likes to make sure things are "safe" and regulated to a degree in order to keep snake oil off the market but a sane consenting adult should be allowed to make the decision to take the risk.
I think that while this is a downer, it is a necessary evil to ensure medicines are safe and actually fit for purpose. I think most people would at least like to know what the safety outcomes and/or side effect outcomes of a medicine actually are before taking it. Furthermore, while we well know that FX-322 is not useless and does achieve its intended and stated purpose(s), the FDA trial process at least enables a medicine to be identified as actually doing something.
Though that being said, I would rather that the treatments were made easily accessible to people should they choose to want to try these providing that they are proven to be relatively safe, don't have any known side effects declared at the time and that the treatment has demonstrated its stated benefit as well.
While we all know that getting an early access to a medicine is ultimately up to the pharmaceutical company developing it, I do feel that the medicine should be available much more simply through compassionate access/right to try than the process currently allows it to be.
With Oregon decriminalizing all drugs, I should be allowed to take a drug that could give me my life back.
Well especially when you consider that FX-322 is also a lot safer than all those to be decriminalised drugs it really should be not even up for discussion or debate and people should be simply allowed to try medicines under the same principals.
I just don't understand if FX-322 continues to show it's safe and in fact works why they wouldn't release it ASAP or allow expanded access when there are so many of us on the verge of suicide and have socially isolated our selves from the world because of our hearing loss?
Safety isn't always binary. Right now the safety is "favorable" amongst a group of about 120 patients to have received FX-322. But what is unknown, and unmeasured, are the side effects that start to exist in a larger population. 120 patients aren't enough to measure significant side effects/negative interactions. These need to be understood so both the physician and patient are making an informed decision before taking the treatment.
I agree that safety has been proven to date with FX-322, however there is always the possibility that this might change and we may end up discovering some adverse outcomes and/or side effects with it at a later date. Thus while I do believe that the medicine really requires further assessment of its risks and its safety situation before it is released, I am of the view that this doesn't necessarily need to be taken to the same levels that tend to be required by the FDA at present either. Essentially it is I think redundant to use the same criteria around safety for all medicines especially, firstly, when it is obvious - before any trials begin - that certain treatments are going to pose greater risks and safety concerns and, secondly, there is often a good idea on the safety risks with medicines during the earlier trials.
Thus I feel that patients, Frequency Therapeutics and the FDA can all be actually much more confident that treatments like FX-322 won't pose as significant risk to patients as just say something like Ritalin which is basically speed which is manufactured commercially without the harmful side effects and additions in the illicit version. Therefore while I am well aware that the FDA requires standards to be set when it comes to safety, I definitely do not think that it is necessary to be so stringent on a seemingly safe medicine like FX-322.
The expanded access on the other hand happens to come down to the company that is manufacturing the medicine and this is a necessary but dissatisfying byproduct of this process. Though the wait may be unfortunate and horrible for some, it is also reasonable that the organisation developing it has the final say on whether they will allow early access or not. They are ultimately the ones who are responsible for its release and for funding the trials and the manufacturing and the distribution until the medicine actually gets publicly released. Thus while it might be for the good of patients to have medicine available early from expanded access, it might be unaffordable or unreasonable for Frequency Therapeutics to actually release FX-322 under expanded access either as well.
While it is excruciating and bothersome to have to wait to see whether we will get a treatment such as FX-322 that ultimately will regrow hair cells, my concerns are somewhat alleviated by the fact that the treatment has shown it works well when used in cochlears in lab work. What I would also say is that if FX-322 is shown to work well when it is injected into individual's ears essentially during the current trial then this will make me even less worried and/or anxious with having to wait to obtain the treatment, even if it is going to mean it won't be made available until the full trial process is completed. Consequently we will know that there is something and that it is just a matter of time rather than having nothing.
Nothing tells me that Frequency Therapeutics will be going slowly to get FX-322 to market at all if it is successful and therefore I see that this treatment will be released at its earliest convenience. Clearly it is an aim of Frequency Therapeutics to turn out a successful FX-322 treatment and also deliver it in the shortest time possible as well. We have seen Frequency Therapeutics tell us this is their goal time and time again actually throughout the trial process which tells me that they genuinely want to help us.