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

Posted on 2/11/18 at 10:15 am
Posted by I B Freeman
Member since Oct 2009
27843 posts
Posted on 2/11/18 at 10:15 am
A drug that will kill the flu virus rampaging the world will be available in Japan in March. It will not allowed for sale in the USA until next year at the earliest.

How many US citizens that this bureaucracy claims to protect will die while the Japanese manufacturer jumps through the FDA hoops?

LINK

quote:

As Americans suffer through the worst influenza outbreak in almost a decade, a Japanese drugmaker says it has developed a pill that can kill the virus within a day. But even if the experimental drug lives up to the claim, it likely won’t be available in the U.S. until next year at the earliest.

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.

Also, Shionogi’s experimental drug requires only a single dose, while patients need to take two doses of Tamiflu a day, for five days.

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.

Scientists at the Japanese company leveraged their work on a blockbuster anti-HIV drug to create the compound, which works differently from existing flu medicines. It blocks the flu virus from hijacking human cellular machinery, Chief Executive Isao Teshirogi said. Switzerland’s Roche has acquired the international license to distribute Shionogi’s experimental drug.

Flu Fighter

A Japanese company says it can prevent the flu virus from hijacking human cells.

“The data that we’ve seen looks very promising,” said Martin Howell Friede, who leads the World Health Organization’s advisory on vaccines, including for influenza. “This could be a breakthrough in the way that we treat influenza.”

Shionogi said Japan’s drug regulator is fast-tracking its approval and could approve it for use in Japan as early as March. The regulator declined to comment. Roche and Shionogi say they will apply for U.S. approval this summer and Shionogi doesn’t expect a decision until next year.


Why, you might ask, would the government treat us so badly??

Hint

quote:

Other players including Johnson & Johnson , AstraZeneca PLC and a startup backed by Merck & Co. are testing new compounds to treat influenza A, the most common flu strain.
This post was edited on 2/11/18 at 10:35 am
Posted by AMS
Member since Apr 2016
6498 posts
Posted on 2/11/18 at 10:17 am to
quote:

A drug that will kill the flu virus rampaging the world will be available in Japan in March. It will not allowed for sale in the USA until next year at the earliest.


You don't kill a virus, baw. Didn't read after beginning with nonsense.
Posted by HubbaBubba
F_uck Joe Biden, TX
Member since Oct 2010
45786 posts
Posted on 2/11/18 at 10:19 am to
What is it about the word, 'experimental' that you don't understand?
Posted by the LSUSaint
Member since Nov 2009
15444 posts
Posted on 2/11/18 at 10:22 am to
quote:

How many US citizens that this bureaucracy claims to protect will die while the Japanese manufacturer jumps through the FDA hoops?


So if they find the drug has after effects 6 months later that causes blindness, idiots like you will scream that the FDA let us down.

frick man, not every single thing these agencies do are bad! If someone walked up to you with a pill from Japan and asked you to take it at your own risk, would you?

But I do understand their WELL deserved bad reputation for being a red tape nightmare.
Posted by I B Freeman
Member since Oct 2009
27843 posts
Posted on 2/11/18 at 10:22 am to
What is it about this you do not understand:

quote:

A Roche spokesman said the compound proved significantly faster at killing the virus, and that its single-dose requirement was more convenient.


You think the Japs would hurt their people but the FDA would not??

How many victims of the flu do you want on your hands as you and the FDA tell they should wait because you know better what is best for them??
This post was edited on 2/11/18 at 10:23 am
Posted by TigerGman
Center of the Universe
Member since Sep 2006
11225 posts
Posted on 2/11/18 at 10:22 am to
quote:

You don't kill a virus, baw. Didn't read after beginning with nonsense.



The body's immune system doesn;t attack and kill a virus?
Posted by I B Freeman
Member since Oct 2009
27843 posts
Posted on 2/11/18 at 10:25 am to
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?
Posted by I B Freeman
Member since Oct 2009
27843 posts
Posted on 2/11/18 at 10:30 am to
LINK

quote:

The levels of influenza-like illnesses being reported now are as high as the peak of the swine flu epidemic in 2009, and exceed the last severe seasonal flu outbreak in 2003 when a new strain started circulating, said Anne Schuchat, the U.S. Centers for Disease Control and Prevention’s acting director. Swine flu, which swept the globe in 2009 and 2010, sickened 60.8 million Americans, hospitalized 274,304 and killed 12,469, according to CDC data. Deaths from the current outbreak will likely far outstrip those of the 2009-2010 season.


“This is a difficult season, and we can’t predict how much longer the severe season will last,” she said. “I wish there was better news, but everything we are looking at is bad news.”

The primary type of influenza this year hasn’t changed enough from previous seasons to be considered a novel strain, Schuchat said. The agency’s virologists are studying it to determine if there are any other explanations for why it’s been so hard-hitting.

“We have a lot to learn still about influenza,” she said. “It’s a wake-up call about how severe influenza can be, and why we can never let down our guard.”

Deaths from influenza and pneumonia, which are closely tied to each other in the winter months, were responsible for 1 of every 10 deaths last week, and that’s likely to rise, Schuchat said in a conference call Friday. There were 40,414 deaths in the U.S. during the third week of 2018, the most recent data available, and 4,064 were from pneumonia or influenza, according to the CDC data. The number for that week is expected to rise more reports are sent to the agency.

It gets worse. The death toll in future weeks is expected to grow even higher because flu activity is still rising—and the number of deaths follow the flu activity. Hospitalization rates are already approaching total numbers seen at the end of the flu season, which may not be for months.

“Unfortunately, more deaths are likely to happen,” Schuchat said. “Over the next few weeks, we do expect and it would make sense to see more pneumonia and influenza-related deaths. The people who are likely to die are already in the hospital.”

This year’s flu could be more calamitous than outbreaks going back decades, but there’s no way to know for sure. It’s difficult to compare the severity of influenza across seasons for more than a handful of years because of changes in how the virus is handled in the U.S. The CDC started recommending universal vaccination to stop the spread of the virus in 2010, after previously targeting only those in high-risk groups who were most likely to die from an infection.


HubbaBubba don't care.
This post was edited on 2/11/18 at 10:32 am
Posted by DarthRebel
Tier Five is Alive
Member since Feb 2013
21262 posts
Posted on 2/11/18 at 11:00 am to
I do not know about the OPs story, but I can tell you the FDA is a corrupt, bribe taking organization.

Big Pharma own them and many drugs that can saves lives never make it out.

Not conspiracy, just fact.
Posted by Quidam65
Q Continuum
Member since Jun 2010
19309 posts
Posted on 2/11/18 at 11:01 am to
But some televangelist went on record saying we have a duck season and a deer season but not a flu season, and we don't need to get flu shots.

Of course her church caused a huge measles outbreak a few years back due to their beliefs.
Posted by RogerTheShrubber
Juneau, AK
Member since Jan 2009
260902 posts
Posted on 2/11/18 at 11:05 am to
Government regulations are more about protecting markets than protecting consumers.
Posted by Stingray
Shreveport
Member since Sep 2007
12420 posts
Posted on 2/11/18 at 11:07 am to
quote:

You don't kill a virus, baw. Didn't read after beginning with nonsense.


Ah, yes. There is no definition of life. So, what is life?
Posted by MrLarson
Member since Oct 2014
34984 posts
Posted on 2/11/18 at 11:14 am to
What in the world does that have to do with anything ITT?

Posted by NYNolaguy1
Member since May 2011
20902 posts
Posted on 2/11/18 at 11:21 am to
quote:

You don't kill a virus, baw. Didn't read after beginning with nonsense.


Do you think vaccines are effective?

If so, how do you think they work?

Or were you under the impression viruses like smallpox were in fact not viruses?
Posted by Spock's Eyebrow
Member since May 2012
12300 posts
Posted on 2/11/18 at 11:50 am to
How do you feel about the FDA's approval of eteplirsen?
Posted by Dale51
Member since Oct 2016
32378 posts
Posted on 2/11/18 at 11:53 am to
I think he's referring to the idea that viruses are technically not alive.
Posted by AMS
Member since Apr 2016
6498 posts
Posted on 2/11/18 at 12:07 pm to
quote:


The body's immune system doesn;t attack and kill a virus?



Well viruses are not alive, so that is about as accurate as saying you can kill a rock.
Posted by AMS
Member since Apr 2016
6498 posts
Posted on 2/11/18 at 12:16 pm to
quote:

Do you think vaccines are effective?


Yes I think vaccines can be effective, but that has nothing to do with my original comment though.

quote:


If so, how do you think they work?


Generally by activating immune system pathways to inhibit or disrupt replication/transcription/translation of viral particles.

quote:


Or were you under the impression viruses like smallpox were in fact not viruses?


No, I understand that a virus is a virus.... which is why I am aware that viruses are not alive and therefore cannot be killed.

There's a reason why viral illnesses are not treated with antiBIOTICS...

Posted by el Gaucho
He/They
Member since Dec 2010
53022 posts
Posted on 2/11/18 at 12:19 pm to
Trump should shut down the fda. It's a crying shame that they make drugs for people with self inflicted diseases like AIDS but deny us innocent hangover sufferers medical treatment
Posted by BobBoucher
Member since Jan 2008
16746 posts
Posted on 2/11/18 at 12:34 pm to
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.
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