re: FDA regulation endangering flu victims in the USA--people dying while FDA stands in way

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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.

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Go back to the Spock's Eyebrows post and address how the FDA handled the approval of eteplirsen. When data clearly supports fast-tracking a drug, the FDA often fast-tracks it. What's highly likely is that this drug isn't really that much better in terms of outcomes that are clinically relevant.

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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

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Define your terms and start reading. But the FDA is actually pretty good about early access to people who truly need it. You've literally posted nothing of clinical relevance. Your only insights are:
1) a tag line of questionable relevance that is refuted two lines later in terms of how useful it is
2) the the Japanese government is ready to allow it.

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access to such old drugs as penicillin and erythromycin.

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I'd wager more people would die and public health would worsen with access to these drugs. I actually had a case of C diff come in a few weeks ago from someone who clearly had a viral infection in which case neither of these drugs were indicated, but they got their hands on it from a friend or incomplete script from before, then gave themselves bad enough diarrhea that they had to be admitted to the hospital when they could have sat at home for a few days and been better without doing a thing.







This is a market where there is already competitors that are superior to nothing. Newcomers in the category need to prove that they are at least not worse than the ones we have, otherwise they have no value at all. The number of deaths you have is listed at 4,000 weekly. That is all influenza + pneumonia without distinguishing what percentage are bacterial or viral, which makes it impossible to determine what number of people would benefit from this drug.




You really like bad science, or you don't like science at all.

Where does it say the new drug saves lives? What is the NNT over tamiflu? Just cuz its one dose doesnt make it superior. Take off the tin foil hat and read. Outcomes are no different than tamiflu. You just want to believe it cuz its ine dose. The article says it takes the same time to obtain control. So where is superiority? More convenient maybe, but not superior.

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A late-stage trial on Japanese and American flu patients found that for the people who took the Shionogi 4507 -3.04% & Co. compound, 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. Quickly killing the virus could reduce its contagious effects, Shionogi said[/b].

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Three times quicker than Tamiflu to kill the virus. IS THAT NOT SUPERIOR???

What about that do you not like?

Do you think dramatically reducing the contagious effects does not save lives??

You guys contort your minds into crazy, illogical thinking. Talk about tin foil hats--yours is so tight there is no oxygen getting to your brain.

You entire argument centers on this statement

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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.

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But somehow in the density of your flawed logic "immediate relief faster" is a bad thing.

You want to support a bureaucracy to what end??? You want to forego the possibility to save lives to prevent WHAT??

What is it about this drug that you do not want in the USA?

To think people that think like you have our lives in their hands.

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Three times quicker than Tamiflu to kill the virus. IS THAT NOT SUPERIOR???

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It doesn't give any data on how that is relevant, because the patients stay sick just as long.

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What about that do you not like?

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Lack of context, facts, and clinical outcomes. No data published in peer reviewed journals.

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Do you think dramatically reducing the contagious effects does not save lives??

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This has merely an implication of reducing the contagious period, which is already suspected to be before symptoms occur. There's no real-world number to show it is effective in doing what you are claiming it does.

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You guys contort your minds into crazy, illogical thinking[/quote
You don't understand clinical data, and even if you did, you don't have any. Literally none that you can reference. Illogical? Find a physician that doesn't think the way I do when it comes to that. I'll wait.

[quote]But somehow in the density of your flawed logic "immediate relief faster" is a bad thing.

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Give me one logical explanation of how two things can last the same amount of time but one gets better faster than the other. These are marketing statements based without numbers to back them up. They were more than welcome to file with the FDA at opening. They chose not to. They still have no public data, and they have someone making claims that symptoms will last just as long but get better faster.

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You want to support a bureaucracy to what end??? You want to forego the possibility to save lives to prevent WHAT??

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Show me data explaining how this saves lives. Your statement from above does not prove it. If you think it does, please give me the sample size, p values, what the comparison drug was, and the methods of the study from which you are deriving the statement "it will save lives."

You don't have it. But you sure are a sucker for shitty marketing publications.

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What is it about this drug that you do not want in the USA?

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It hasn't been proven nonferior to drugs we have that do the same thing, published its trials, or filled for approval with the FDA yet.
Nowhere did I say I didn't want this stuff here. Hell, I've tried for over half an hour to find any sort of published data from trials on it. There isn't any widely available that I'm able to find.

The reason, then, I want to wait is that I took an oath not to harm people. It would be beyond irresponsible to prescribe this medication with the current available data, unless you know more than I do. But what's in this article is of essentially zero quality.

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To think people that think like you have our lives in their hands.

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So I should write a letter to the FDA saying, "I know that 4,000 deaths last week may have some percentage that is not insignificant that is related to influenza. We currently have three medications to which influenza is pan-sensitive to at this time. There is another medication not yet available in Japan that can kill the virus up to three times faster. Apparently symptoms last the same amount of time, there is no data on mortality rates, side effects of the medication, the number of people who were hospitalized after being on this medicine vs another medicine or nothing, the number of hospital patients who were intubated vs those on nothing or the standard of care, but a poster on Tigerdroppings assures me that being single dose and able to kill the virus in 1/3 the time means positives to all of those specific scenarios. Please accept Japan's approval of this drug to market as our own so we can start saving untold numbers of lives."



Basically, your lack of understanding anything that's important that goes into medical decision making at the level of the physician or FDA combined with your inability to understand the points made above (each one I've already made in a previous post, if not multiple) makes further iterations of your same, boring point uninteresting to me.

If you would like me to expand on any of the things I have explained so you could understand why those of us who would be prescribing the medication are ok with waiting on it, I'll be more than happy to. If you want be to simplify it further (this is in no way an insult. I just see that you aren't understanding what I am saying) or dress it up to a higher level, I'm happy to do so. If you would like that, the first thing you'll need to do is read up on "Levels of Evidence" so that you will understand exactly how weak your argument is or show me the publications it comes from. I'll even be happy to pay for them if that's the case- I just can't find them available anywhere.

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OP was suggesting the FDA suppresses new drugs because it's in cahoots with other pharma companies, which is the board's usual conspiracy theory nonsense. I offered eteplirsen as a counterexample, as it was approved despite the lack of evidence to support its release, so maybe they're in cahoots with Sarepta investors.

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Ah. I misunderstood your take. I thought you were showing an example of a "promising" drug in a unique category that showed promising enough results to be applied without all the i-dots and t-crosses, which is what it seems like the OP wants here except for the new drug not being in a novel class at all.
As I understood it, the FDA gave it a real weird approval which allowed it to sell but also required them do an RCT vs placebo or standard of care.

You are so wrapped up in the bureaucracy that you fail to use common sense---

1) this obviously is not a harmful drug or a "snake oil" drug as it has been proven in late stage trials and is a drug that a very reputable company has been searching for and has been developing for 10 years. It has been licensed to a very reputable Swiss company. It has been reviewed by the World Health Organization. It is set to be released for sale by the very advance regulators in Japan.

2) it clearly has real advantages--it kills the virus in 24 hours-three times quicker than the competition. Logically (a trait that you obviously lack) a good thing that will reduce the spread of influenza AND thus the number of people who will die.

3) the entire POINT of thread is that FDA is going to take at least another year to approve it and make it available to the American public.

Climb out of the bureaucratic fog you live in and THINK.

If there is problem with this drug that somehow all these people--the company, the Japanese regulators, the WHO, Roche have hidden or have missed then we have tort laws to handle that. There is nothing about the health of the American public the FDA is protecting in this case.

This is an article in the Wall Street Journal not some drug piece the last drug rep left you with that poboy he bought you.

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1) this obviously is not a harmful drug or a "snake oil" drug as it has been in late stage trial drug that a very reputable company has been searching for and has been for 10 years. It has been licensed to a very reputable Swiss company. It has been reviewed by the World Health Organization. It is set to be released for sale by the very advance regulators in Japan.

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Ok. Where is that data?

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2) it clearly has real advantages--it kills the virus in 24 hours-three times quicker than the competition. Logically (a trait that you obviously lack) a good thing that will reduce the spread of influenza AND thus the number of people who will die.

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Logic doesn't apply to clinical medicine all the time. You don't even know whether that's in vivo or in vitro. The spread can often occur prior to symptoms even being displayed.

I can't say this enough. You think this is a "gotcha" and that I don't understand this point. I do. It's probably nothing more than a marketing ploy tagline that has no real-world benefit. This happens quite often with medications. They claim these little benefits that aren't tied to patient outcomes, which you still don't grasp as being the important thing.

You still don't even know where this statement comes from, thus I question its relevance.

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3) the entire POINT of thread is that FDA is going to take at least another year to approve it and make it available to the American public.

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And when did the company apply for FDA approval? Why didn't they do it concurrently with their own system?

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Climb out of the bureaucratic fog you live in and THINK.

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I'm actually only thinking about real world data application. You have none, which makes this fairly uninteresting. Again, find me what the statement of its killing time is even based in, and we may have something to talk about.

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There is nothing about the health of the American public the FDA is protecting in this case.

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Sure there is. Data supports use of other medications. There are no data to support this one other than "they are going to start using it in other countries."
That's bad science, and without studies showing benefit, anyone recommending it over the current medications ought to have their motive checked.

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This is an article in the Wall Street Journal not some drug piece the last drug rep left you with that poboy he bought you.

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You think the Wall Street Journal is a reputable scientific publication? It brings up a very interesting drug that may even be "the next big thing," but people from WSJ don't critique scientific journals nor make the data available for criticism.


To not scrutinize is dangerous. You've got nothing to scrutinize but a statement with no real understanding of the statement's foundation or application.


At least the drug reps know side effects, mortality rates, hospitalization rates, the average age and comorbidities of the average person who was studied. And I very rarely accept a lunch.

Twisted thinking.

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Twisted thinking.

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Evidence-based medicine is twisted thinking?

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I B Freeman

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Hopeful Doc has been very kind towards you in his dismantling of your argument. You have mischaracterized his responses worse than the British “so you’re saying...” meme lady.

There is no peer-reviewed studies of the relevant efficacies of this drug. You are fixated on a marketing line equivalent with BMW being “the ultimate driving machine”, Carlsberg claiming the title of “the world’s best beer”, or any number of roadside diners with “world famous” pies.