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re: FDA regulation endangering flu victims in the USA--people dying while FDA stands in way
Posted on 2/11/18 at 12:46 pm to I B Freeman
Posted on 2/11/18 at 12:46 pm to I B Freeman
So, pharma companies that spend billions lobbying to the US have been able to steal their formula and are working on their version to be approved by FDA? Wouldn't surprise me.
0
Posted on 2/11/18 at 2:10 pm to I B Freeman
quote:
Both Shionogi’s compound and Tamiflu take roughly the same amount of time to entirely contain flu symptoms, but Shionogi says its compound provides immediate relief faster.
So it takes the same amount of time for the inflammatory cascade to settle down, there is no data included to suggest whether the mortality, morbidity, or hospitalization rate is affected at all. There is also no talk about cost.
As inhibitory as the FDA is about things, I can tell you I would never write a script without all of that data. The blurb that has you excited is just a marketing blurb made to get people excited. It offers almost nothing of scientific value.
Posted on 2/11/18 at 2:22 pm to HubbaBubba
quote:
What is it about the word, 'experimental' that you don't understand?
You may consider looking into how comical trials work. It's "late phase" and available (expected) in March, meaning that they know promising results from animal models, then
Phase 1) they give the drug to healthy people and make sure it doesn't harm them and observe the side effects that do occur
Phase 2) they get a small group of people who are sick, give them the drug, ensure it works and again, check for side effects in the sick group
Phase 3) is a large group of sick people, usually across multiple centers, and they're actually treating sick people on a broad scale.
Because of that, phase 3 is nearly to the point that you may want to argue "well why not let all these dying people try it?" There's actually a specific law/set of laws called "compassionate use" which typically applies more to things like chemo drugs than anything else, but it also was used in the Ebola treatments a few years back if I recall, as well as in some end-stage AIDS.
Counterpoint: this should be in people who don't have other options. We actually have a few options here in the US already. As much hate as Tamiflu gets for its cited "you get better 12 hours earlier" conclusion, there isn't a randomized trial of the people that it really matters for: those who are in the hospital critically ill or who already have underlying lung disease. It would be unethical to placebo-control a trial with these people, because the standard of care is already to give them Tamiflu (or another similar drug).
Basically, the only thing revealed here is that it is a single dose regimen instead of a 10-dose, 5-day regimen that isn't available here yet without any groundbreaking revelation that it's more useful
Posted on 2/11/18 at 2:31 pm to I B Freeman
quote:
Are you implying that Shionogi is somehow less reputable than a US drug maker?
Are you saying tort would not work to prevent product liability when dealing with a multi national Japanese drug maker but does on US drug makers?
No, you are saying those things...I was pretty clear.
Posted on 2/11/18 at 3:25 pm to the LSUSaint
Yes you are clearly on the side of bureaucrats over the interest of the citizens.
This post was edited on 2/11/18 at 3:26 pm
Posted on 2/11/18 at 3:27 pm to BobBoucher
quote:
Gotta prevent that Zombie apocalypse. Let the Japanese unleash the T-Virus on their population. We'll watch. And I got that zombie apocalypse insurance anyhoo. So I'm good.
Thankfully japan is an island. Easy to quarantine.
Posted on 2/11/18 at 3:29 pm to I B Freeman
quote:
Yes you are clearly on the side of bureaucrats over the interest of the citizens.
It's not in the interest of citizens to allow drugs that haven't proven their worth by companies that have chosen a different route to market first.
Posted on 2/11/18 at 3:33 pm to Hopeful Doc
quote:
It's not in the interest of citizens to allow drugs that haven't proven their worth by companies that have chosen a different route to market first.
That is your opinion??
Why not this---tell patients the very modern, very sophisticated Japanese government has decided to allow the sale and the distribution of a very effective influenza cure that will likely prevent your possible death now that you have contracted the flu but the FDA bureaucracy has not recommended it yet. Do you want the drug or not?
This post was edited on 2/11/18 at 3:57 pm
Posted on 2/11/18 at 3:36 pm to I B Freeman
How many of the projected 4000 deaths a week would this drug have to prevent before you government lovers sided with the dying citizens over the big pharma protectors at the FDA??
Posted on 2/11/18 at 3:55 pm to I B Freeman
quote:
this---tell patients the very modern, very sophisticated Japanese government has decided to allow the sell and the distribution of a very effective influenza cure that will likely prevent your possible death
How does it compare to the ones already available that sought FDA approval?
Posted on 2/11/18 at 3:58 pm to Hopeful Doc
Well the manufacturer says it is far superior. One dose vs 10 of Tamiflu which is in short supply. Symptoms over in 24 hours.
Read the article.
Let me see if I got this straight---the cost of the drug means it is your decision whether or not a patient should have the option to take the drug or not? Do you know the financial state of each of your patients?
Read the article.
Let me see if I got this straight---the cost of the drug means it is your decision whether or not a patient should have the option to take the drug or not? Do you know the financial state of each of your patients?
This post was edited on 2/11/18 at 4:00 pm
Posted on 2/11/18 at 4:02 pm to I B Freeman
quote:
Symptoms over in 24 hours
The article actually said the viral load drops in 24h but the symptoms last exactly as long as Tamiflu, and I copied that text in my first post
quote:
One dose vs 10
This isn't particularly useful.
quote:
Read the article.
I did. I was critical of it in a post above. Specifically, I even mentioned the dosing regimen as more of a market ploy than it being useful.
And nowhere in the article do that claim superiority to current marketed neuraminidase inhibitors with any real world effects. They postulate that it may reduce spread of the virus. This isn't validated.
Edited to change the word "particular" to "particularly"
This post was edited on 2/11/18 at 4:03 pm
Posted on 2/11/18 at 4:04 pm to Hopeful Doc
I will put you down as in favor of protecting Tamiflu manufacturers from competition over helping patients with more choice for more effective treatment.
quote:
the median time taken to wipe out the virus was 24 hours. That is much quicker than any other flu drug on the market, including Roche AG’s RHHBY -0.07% Tamiflu, which the trial showed took three times longer to achieve the same result.
This post was edited on 2/11/18 at 4:06 pm
Posted on 2/11/18 at 4:05 pm to I B Freeman
quote:
Let me see if I got this straight---the cost of the drug means it is your decision whether or not a patient should have the option to take the drug or not?
No. Not at all. That is a single factor. Did you miss the statements about mortality, morbidity, and hospitalization rates?
quote:
Do you know the financial state of each of your patients?
When prescribing a medication that has a high cost with cheaper alternatives, I have an informed discussion with my patient about the merits of each option and ask which one they prefer. I'll often give my opinion as to which I think is better.
Posted on 2/11/18 at 4:06 pm to I B Freeman
quote:
I will put you down as in favor of protecting Tamiflu manufacturers from competition over helping patients with more choice for more effective treatment.
I'm still trying to decide whether you lack reading comprehension of my posts or just haven't read them.
Posted on 2/11/18 at 4:06 pm to Hopeful Doc
Then you would certainly prefer this drug but you do not have that choice because of the bureaucracy.
quote:
the median time taken to wipe out the virus was 24 hours. That is much quicker than any other flu drug on the market, including Roche AG’s RHHBY -0.07% Tamiflu, which the trial showed took three times longer to achieve the same result.
Posted on 2/11/18 at 4:08 pm to I B Freeman
quote:
the median time taken to wipe out the virus was 24 hours. That is much quicker than any other flu drug on the market, including Roche AG’s RHHBY -0.07% Tamiflu, which the trial showed took three times longer to achieve the same result.
Again, the next line is
quote:
Both Shionogi’s compound and Tamiflu take roughly the same amount of time to entirely contain flu symptoms, but Shionogi says its compound provides immediate relief faster
Most of the deaths are related to the inflammatory cascade which isn't affected much by this drug.
I'm not for protecting Tamiflu, I'm for basing approval on scientific data that is peer-reviewed and published rather than a pandering statement released as a marketing ploy to people who don't understand how to read it.
ETA; it's two lines later, not the next line
This post was edited on 2/11/18 at 4:10 pm
Posted on 2/11/18 at 4:10 pm to I B Freeman
I kinda see why the FDA heavily regulates these types of medications. When these strains morph and become immune to certain treatments, you could potentially have a pandemic on your hands.
Posted on 2/11/18 at 4:13 pm to I B Freeman
quote:
Then you would certainly prefer this drug but you do not have that choice because of the bureaucracy.
No. None of the points I address are in there. Containment of serum-detected viral loads don't necessarily correlate with outcomes (again, morbidity, mortality, and hospital admission rates). Heck, it clearly doesn't even correlate with symptoms (see paragraph two later that I have referenced multiple times).
They also don't publish the name of the compound, making it quite difficult to see what's been published through phase 1&2 trials. They don't want people to know about published data, they want people to be outraged they they can't buy it.
Posted on 2/11/18 at 4:17 pm to Hopeful Doc
No you are in favor of the FDA over the citizens.
The trials are late stage and the Japanese government is ready to let it be sold.
Why should we not let the drug be sold also? We have the same information available to us that the Japanese have available to them.
The Japanese have a far more successful health care system--check the life expectancy in both countries-- and we are so arrogant to think only our bureaucrats are to be trusted!!
I bet you that more people have died from the delays of drugs in the USA due to the FDA and from the prescription requirements on so many drugs because of the FDA than the FDA has saved. There is no way to prove that BUT without question our cost of healthcare would be much less if we didn't have to pay for a doctor's visit and a pharmacist's fee to have access to such old drugs as penicillin and erythromycin.
The trials are late stage and the Japanese government is ready to let it be sold.
Why should we not let the drug be sold also? We have the same information available to us that the Japanese have available to them.
The Japanese have a far more successful health care system--check the life expectancy in both countries-- and we are so arrogant to think only our bureaucrats are to be trusted!!
I bet you that more people have died from the delays of drugs in the USA due to the FDA and from the prescription requirements on so many drugs because of the FDA than the FDA has saved. There is no way to prove that BUT without question our cost of healthcare would be much less if we didn't have to pay for a doctor's visit and a pharmacist's fee to have access to such old drugs as penicillin and erythromycin.
This post was edited on 2/11/18 at 4:18 pm
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