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Started By
Message
re: FDA regulation endangering flu victims in the USA--people dying while FDA stands in way
Posted on 2/11/18 at 9:08 pm to BamaChemE
Posted on 2/11/18 at 9:08 pm to BamaChemE
quote:
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.
How can you say that?? Where do you get that information?
Hopeful Doc is trapped in convoluted thinking and so are you. You ignore the fact that any bad actor that brings a product to market in the USA--let alone a drug--faces tort remedies that can ruin them. Tort remedies that do more than any FDA bureaucrat to insure drug safety.
The list of people who have invested in and have reviewed this drug listed in this article alone should be be enough evidence to allow this drug to be sold in the USA.
If with the information these people have they are willing to subject themselves to the legal environment of the USA then I suspect this drug is what they say it is.
It should be my own decision whether to use this drug or not.
2
Posted on 2/11/18 at 9:14 pm to I B Freeman
quote:
What is twisted is this arcane process that slows technology availability to the citizens under the guise of "protecting" them. This process that because of it's shear complexity is harmful.
Here's the thing though: the rules are there and have been for a while.
Many companies choose to make their data available early and apply here concurrently with the US. If it isn't life saving and alternatives are available, a year entry isn't unreasonable. We don't live in a vacuum where the perfect "no one dies from witholding or administration" scenario exists.
There are a lot of reasons I dislike FDA process and decisions, but this drug is an utterly horrible example of why, and it's actually a pretty solid reason to hold it out. I've gone through the points several times. Would reforming it do some good? Probably. Should they blindly accept WHO-approved drugs? Gosh, no. Most of the WHO's scope is looking in the third world and how to treat people there. They suffer from very different diseases with different circumstances and the way medicine is practiced there is quite different because that is what saves more lives there.
If there were a global set of standards agreed upon by many of these governing bodies, I think that would be a good thing. But when it comes to healthcare, I sure am glad I'm in America. It's overpriced and due for a whole host of makeovers, but the barrier to entry for the treating physician is among the highest in the world, and the access to so many options is also very high up the list.
Posted on 2/11/18 at 9:26 pm to I B Freeman
quote:
How can you say that?? Where do you get that information?
Searching the company's name and influenza in multiple search engines, both general web and Medline/pubmed show nothing other than links to your article. There is a lack of widely available sources of the claim.
quote:
Hopeful Doc is trapped in convoluted thinking and so are you.
You seem to think that it can kill the flu virus fast is a reason it should be allowed here.
Bleach can also kill it 1,000 times faster than either drug. I wouldn't recommend drinking or injecting it, though.
quote:
It should be my own decision whether to use this drug or not
You're more than welcome to think this, but you're wrong. Want proof? Walk into a doctor's office and tell them you want (pick an opiate and a benzodiazepine).
If there were no public health implications, I may see your argument. But there are. And I don't. And if you think you have the wherewithal to treat respiratory infections in yourself and others based on what you've presented here, you've got quite a convoluted thought process yourself there, ma'am.
Posted on 2/11/18 at 11:16 pm to I B Freeman
Don't know why youre singling out the FDA when the jap regulating body isn't even approving it till March - after or near the end of flu season - and that's with a fast-tracked approval.
Granted, at least they'd probably have it by the 2018-2019 flu season, although I don't expect this stuff to be cheap.
Also, any discussion about this is naught without the actual studies. Talking about new drug approvals without an analysis of the studies is folly.
Granted, at least they'd probably have it by the 2018-2019 flu season, although I don't expect this stuff to be cheap.
Also, any discussion about this is naught without the actual studies. Talking about new drug approvals without an analysis of the studies is folly.
Posted on 2/11/18 at 11:18 pm to Hopeful Doc
quote:
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.
I'm generally against drug regulations with respect to restricting access, but my primary exception is antimicrobials.
You can really not only frick up your own shite, but frick up the world by mismanaging these things.
Posted on 2/11/18 at 11:45 pm to I B Freeman
quote:
Yes you are clearly on the side of bureaucrats over the interest of the citizens
Riiiiiiiiiiiiiight..you got it all figured out.
So, the "interest of citizens" is to put a drug out there that doesn't have data on long term effects?
Posted on 2/12/18 at 3:11 am to I B Freeman
quote:
How can you say that?? Where do you get that information?
How about we look at the section of text you love to post:
quote:
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
Oh imagine that. Maybe they might have a interest in puffing THEIR drug up a bit. Of course, if we could find some peer-reviewed work, it might be a different case. But to blindly take what the MANUFACTURER says as gospel is just asking for trouble.
To put it in a different context:
Do you trust the film studios who talk about the benefits of Louisiana's film credits OR are you a little skeptical because of their inherent bias?
quote:
You ignore the fact that any bad actor that brings a product to market in the USA--let alone a drug--faces tort remedies that can ruin them. Tort remedies that do more than any FDA bureaucrat to insure drug safety.
Oh yeah. Those are disastrous settlements; I see the Pfizer paid 2.3 billion to the FDA and 468 million to their shareholders in a settlement for both Bextra and Celebrex.. Probably not a great source but something to start with
But it looks like 1 year's sale of Celebrex was 3.3 BILLION, which paid for that settlement and fine and with plenty of revenue to spare. LINK
quote:
Last year, Celebrex sales leapt 75 percent to $3.3 billion. In December, during the week when word of its cardiovascular risk became public, Celebrex claimed 44 percent of prescription pain killer sales in the retail market with revenues of $44 million. By the week ended Feb. 11, Celebrex's share fell to 23 percent with sales of $24 million, according to Verispan, which tracks prescription drug information.
BTW, tort remedies are great but don't bring people back to life or necessarily make them whole. I might lose my hand or leg due to some accident or faulty product and get paid some cash, but I MIGHT still want the appendage.
This post was edited on 2/12/18 at 3:12 am
Posted on 2/12/18 at 3:15 am to I B Freeman
quote:
You think the Japs would hurt their people but the FDA would not??
Someone needs a history lesson.
Posted on 2/12/18 at 5:01 am to bbrownso
Why would you post examples of drugs the FDA cleared but were bad in defense of the FDA?
Posted on 2/12/18 at 5:04 am to Tiguar
Why do you people think a drug with sucessful late stage trails lacks whatever data you want?
Posted on 2/12/18 at 5:06 am to Tiguar
75% of antibiotics used worldwide are used without prescription.
Posted on 2/12/18 at 5:13 am to I B Freeman
I listened to an interesting podcast about a German drug company that was trying to get a “morning sickness” drug approved here and the FDA wouldn’t allow it. Turns out is was causing horrible birth defects in Germany but they didn’t know. Can’t recall the drug name off hand. At any rate I think if you are going to have a system here where the FDA is supposed to be credible then you have to let them “do their thing”.
Posted on 2/12/18 at 7:16 am to I B Freeman
quote:
75% of antibiotics used worldwide are used without prescription.
What are the rates of complications due to non prescribed antibiotics and Resistance rates of ESBL, Staph aureus, and Pseudomonas aureuginosa where they are available without scripts?
Public health is significantly more important than your perceived "right" to have whatever medicine you want whenever you want it.
Posted on 2/12/18 at 7:19 am to I B Freeman
quote:
Why do you people think a drug with sucessful late stage trails lacks whatever data you want?
Because they haven't published from their early trials in any credible journal that we can find. See, some of us do this for a living. "wonderdrug" early stuff like this comes out a lot. It's usually hype and not that much different than what we have when the news source is WSJ and not NEJM.
You seem to think a manufacturer statement that hasn't been evaluated by drug-governing bodies is worth more than a the paper it's printed on prior to finishing its trials. It's not.
Posted on 2/12/18 at 7:24 am to I B Freeman
quote:
Why would you post examples of drugs the FDA cleared but were bad in defense of the FDA?
You're saying current tort law is way worse for someone who does something wrong in this field than anything else around. He posted an example of a drug company more or less hiding data/lying about it (which they pretty much all have done before) that lost less than 1 year of sales for doing so. And that's a year of sales for a single drug only, not their whole catalogue. Seems like this is an example of your statement suggesting people are protected is pretty darn false.
Would you happen to have an example of how the statement you made is true? Or do you think that slap on the wrist is severe enough to stop them from doing this?
Posted on 2/12/18 at 7:29 am to Robin Masters
quote:
listened to an interesting podcast about a German drug company that was trying to get a “morning sickness” drug approved here and the FDA wouldn’t allow it. Turns out is was causing horrible birth defects in Germany but they didn’t know. Can’t recall the drug name off hand. At any rate I think if you are going to have a system here where the FDA is supposed to be credible then you have to let them “do their thing”.
Thalidomide is probably what you're referring to. It's a dated but good example of the FDA review process and how foreign drug agencies can overlook things that are fairly important.
Bonus point: it has a line in Billy Joel's "We Didn't Start the Fire" if you want to know how to pronounce it or an excuse to listen to Billy Joel with context.
Posted on 2/12/18 at 8:28 am to the LSUSaint
quote:
the FDA let us down.
You mean like these 35 examples of FDA approvals that caused serious side effects? I don't see how the FDA has made us any better off.
LINK
Posted on 2/12/18 at 9:30 am to Hopeful Doc
quote:
What are the rates of complications due to non prescribed antibiotics and Resistance rates of ESBL, Staph aureus, and Pseudomonas aureuginosa where they are available without scripts?
you tell me--you are the one that is using that as an argument.
How many lives are saved by the cheap availability of antibiotics in areas of the world that do not require prescriptions???
I doubt you will spend any time on that given it does not fit your narrative.
Posted on 2/12/18 at 9:40 am to I B Freeman
quote:
you tell me--you are the one that is using that as an argument
Those rates are high. I'll find numbers. But an insurance of this is common traveler's diarrhea in certain parts of the world, in particular Indonesia. Ciprofloxacin is OTC there. Essentially all the important reasons to use it are resistant to it. Thus, on the CDC's website travel section, it recommends against having that medication with you, as it is near useless.
quote:
How many lives are saved by the cheap availability of antibiotics in areas of the world that do not require prescriptions???
Probably very few. It's rare that lives are saved with antibiotics in the outpatient setting and much more likely to breed resistance over bugs that aren't harmful or viral in nature to begin with. It's a different story when we talk about needing to be admitted.
quote:
I doubt you will spend any time on that given it does not fit your narrative.
You still haven't posted a single data-backed fact or responded to 70% of my inquiries.
Posted on 2/12/18 at 9:43 am to I B Freeman
Lets see the data.
How many involved in trials?
When administered?
How were side effects collected?
How many involved in trials?
When administered?
How were side effects collected?
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