You said you're a musician. I am (was) too. But I also know electronics backwards and forwards because I'm an engineer. High frequency waves carry far more energy than low frequency waves. Therefore our hearing loss is more than likely associated with damage to our high frequency regions of our cochleas. Our hearing damage is not from the bass speakers but the tweeters. Most sounds in our natural environment aren't above 16kHz. That's why we don't perceive our hearing loss. Trust me, it is there. Our hair cells are like Hiroshima in those frequencies. Your tinnitus is from loud noise. Get with the program doug. Think about it. Stop naysaying me. If you want we can have a guitar shred-off to settle this.
Also, stop defending the FDA, lest you look stupid. Most intelligent people in the US understand how fucked up the government is. Plus the powers of the FDA are blatantly unconstitutional per the non delegation clause.
Seriously, wise up.
John, I'm well aware of everything you have posted, and in fact, have posted in detail in the past about there being more energy in higher frequencies. I'm also aware that at some point in my higher frequencies there will be a loss somewhere. However, the loss at these higher frequencies is prevalent in pretty much everyone on the planet, including all the other musicians I've worked with. The problem is that not all of us have tinnitus and there's no current explanation why only approximately 10% of us hear it with upper-frequency damage and hidden hearing damage. There's no doubt that hearing loss is involved somehow, but there has to be more to it. It's a complex issue.
One model shows there's a link with our limbic system suggesting something has gone wrong it. There have been studies using various brain imaging techniques that highlight a difference between tinnitus sufferers and non-tinnitus sufferers. Others suggest that it is down to hyperactive neurons in the auditory cortex causing phantom sounds. There's a theory that suggests that activity is suppressed in the KV channels of our DCN, and/or there's hyperactivity in the fusiform cells.
Hearing damage alone in these cases can not explain tinnitus. If this were the case, everybody on the planet would have it because we all have hearing loss, bar none. Every soldier, just like every musician, will have hearing loss somewhere. However, not all soldiers and musicians have tinnitus. Some researchers believe there is a cocktail between stress and hearing loss that creates the perfect storm for tinnitus to emerge, but this is just a theory.
With all this said, you still haven't answered what you expect people to do regarding FX-322?
In your other thread I wrote this:
Are you aware there was a $1.8m report in 2006, by the Institute of Medicine, that found major problems with the FDA's process for ensuring the safety of drugs in the US?
The FDA produced a report of their own to address the issues which can be found here:
https://www.fda.gov/downloads/Drugs...ormationforPatientsandProviders/UCM171627.pdf
I suggest reading it all, but I'll post an excerpt below:
New drugs, devices, and diagnostics present the greatest opportunity currently available to improve healthcare and the way medicine is practiced; but all medical products pose potential risks. The FDA is challenged to make sure that it consistently balances access and innovation against the steps taken to improve our approach to safety issues. The Agency's efforts to improve drug safety must not dampen the process of medical innovation that could itself enable safer approaches to drug development and drug use. Stimulating the development of products that can be used safely and effectively by patients suffering from unmet medical needs is important. Safety and innovation, as well as efficiency in drug development, do not necessarily conflict but are dependent on one another. A more modern, efficient, and risk-based drug development process will improve FDA's ability to detect safety-related problems earlier. FDA will not achieve enhanced safety programs without also pursuing innovation in the way that drugs are developed.
The emerging science of safety also offers a way to partially solve a fundamental dilemma: the trade off between safety and access. A clear example of this trade off occurs when FDA, after analysis of adverse events, considers whether to withdraw a drug from the market for safety reasons. While withdrawal of the drug would avoid further adverse events, it would also deprive patients for whom the drug is effective of its benefits. If, however, new science enables us to determine that the adverse events are restricted to a small, identifiable segment of the population, public health could be improved by making the drug available to others who could benefit without undue risk.
The new science of safety, by its very nature, will require an interdisciplinary team approach to assessment, incorporating experts in genetics, cell biology, and other basic sciences with clinical pharmacologists, clinicians, statisticians, epidemiologists, and informatics experts. We agree with the IOM that adequately incorporating the input from these various experts will require a much more formalized, semi-quantitative approach to benefit and risk analyses and continuing reorganization of regulatory processes. We regard improving our approaches to risk and benefit analysis to be one of the important facets of the science of safety that urgently requires additional development.
There's more info here:
http://nationalacademies.org/hmd/Re...the-Public/Change-Drug-Safety-Policy-FDA.aspx
Again, I encourage activism, but I'm not sure what you want people to do at this stage?
FX-322 is in the very early stages and has to go through a vigorous process. A few people off a forum will not be able to change the regulations. It is an unknown drug in early development.
If the data from phase IIa, in a few years, is promising, you could launch a campaign to try and get it fast-tracked. However, if it's a drug that looks to be safe and efficacious then it will likely achieve this status organically. Until then it's a waiting game.
At this stage nobody will listen to you, and this likely includes Frequency Therapeutics.
Are you suggesting you can change the regulations on new drugs?
What is it that you want to do exactly?
Member
that's just too much & too far...
. I've invested in a few medical start ups back when I was heavily into the stock market; I used to take it really seriously. I met with CEO's and chairmen, and was in direct email contact with some of them after sharing a few whiskeys with them.
