The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.
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The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.
Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.
A lot of people with herpes would be angry if they found out.
A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.
@jeneralist MS-haver here. Beyond furious.
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@crazyeddie
Yeah. There are shades of both. We have the obviously inept senate PLUS the obviously unhinged Caligula destroying a world leading economy for no gain (or negative gains due to petty grievances).@jcutting @crazyeddie why does everyone keep bringing up Caligula? Isn't he more like Nero?
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The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.
Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.
A lot of people with herpes would be angry if they found out.
A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.
Can Moderna sue the FDA ? If they conducted their studies the way FDA wanted them done, then it's a breach of contract by the FDA, isn't it?
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@mirth @ujay68 @jeneralist I don't know. I don't have access to their internal accounting system.
@drwho @ujay68 @jeneralist Eyeballing some news articles they pay maybe something like $100M/year in bonuses? Not insignificant, but proportionally also probably doesn't change the overall financial picture by a whole lot.
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Is there any reason they couldn't apply for approval in Europe or Canada or some other place that hasn't lost his mind?
@Mikal @jeneralist
I think they were targeting a market that they could make a lot of money out of. US regs tend to favor price engineering - or at least it's permissible to it. -
Moderna has its new influenza vaccine under review in the EU, Canada, and Australia: https://www.nbcnews.com/health/health-news/fda-declines-review-modernas-mrna-flu-shot-rcna258436
But that does not make what Trump and those with him are doing any less deadly.
@michael_w_busch @jeneralist Very true. My comments were a bit insensitive and callous, especially to all of us whom are affected by our current admin.
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They 100% could apply for approval in Europe or Canada but they won't because without access to the US market their isn't enough profit for them... and companies like Moderna don't care about people, they only care about profit.
Europe, Canada, et al need to force the issue by changing patent law (at least for medical patents but honestly it would be best to cover all patents) to include a 'use it or lose it' clause. If companies don't pursue approval Government's should have the right to step in and use the companies patents to develop the drugs themselves.
@RantingCanuck @Mikal @jeneralist
We would do even better if these companies were cooperatives driven by community benefit instead of publicly traded corporations driven by profit. Profit (as opposed to wages) is intrinsically extractive -- the antithesis of healthcare or anything else related to customer well-being.
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@jeneralist @ujay68 So basically it's confirming that people in the USA are paying far too much for their medication. And the Pharmaceutical companies don't care too much, because if the people survive to old age they will make bank on them.
@ariaflame @jeneralist @ujay68 We need consumer cooperatives in healthcare, not publicly traded companies. It's a massive conflict of interest.
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The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.
Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.
A lot of people with herpes would be angry if they found out.
A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.
@jeneralist most likely RFK Jr has a homeopathy treatment that will be FDA approved and he'll make millions while people suffer.
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@AzureArmageddon @jeneralist that really does make me wonder that if the United States ever fixed its medical system to be in line with the rest of the civilized world. Would that take away the actual impetus for medical research that has been improving the lives of people worldwide?
@LoneLocust @jeneralist Maybe not, but ceasing to be an outlier might push average prices up globally.
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@AzureArmageddon @jeneralist that really does make me wonder that if the United States ever fixed its medical system to be in line with the rest of the civilized world. Would that take away the actual impetus for medical research that has been improving the lives of people worldwide?
@LoneLocust @AzureArmageddon @jeneralist
In our current economic system, it probably would. (And we are about to find out, because the US is on a terrible trajectory right now and on course to cease being a major player.)
That's why profit shouldn't be the driver for medical research. If these companies were consumer cooperatives, their purpose and focus would be to benefit their customers, not to extract money from their customers' pockets and put it into shareholders' hands. Then it wouldn't matter if the drug was profitable. It would matter if it was affordable and worthwhile to develop, manufacture, and deliver it.
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The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.
Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.
A lot of people with herpes would be angry if they found out.
A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.
@jeneralist Too crazy for words, pure madness…
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The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.
Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.
A lot of people with herpes would be angry if they found out.
A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.
@jeneralist this absolutely sucks. But it also shows how we need to (as a world) move beyond the US.
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The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.
Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.
A lot of people with herpes would be angry if they found out.
A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.
@jeneralist Why is the US market more "important" than Asian, European etc. markets?
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@jeneralist They could still develop vaccines for the other 8 billion people on this planet, couldn’t they? If they wanted to? No?
They could, they don't want to.
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@jeneralist Why is the US market more "important" than Asian, European etc. markets?
Some back-of-the-envelope calculations: new vaccines are generally introduced to more affluent countries first, especially for diseases that aren't immediately fatal. The market for vaccines against EBV, HSV, and VZV would be in this category.
EU: 450M people
Canada: 40M
US: 350M
Australia & NZ: 30MWithout US, the market is about 40% smaller.
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The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.
Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.
A lot of people with herpes would be angry if they found out.
A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.
@jeneralist @Taco_lad the point about ROI exposes the first principle for these organisations: massive profits. They should Give the research to another company that is interested in supporting human health first and profit second.
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Some back-of-the-envelope calculations: new vaccines are generally introduced to more affluent countries first, especially for diseases that aren't immediately fatal. The market for vaccines against EBV, HSV, and VZV would be in this category.
EU: 450M people
Canada: 40M
US: 350M
Australia & NZ: 30MWithout US, the market is about 40% smaller.
@jeneralist Well, the US doesn't need any vaccines according to its Secretary of Disease. So, what market?
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@ancientsounds @jeneralist They're probably relocating assets for this. I don't know for sure, I got laid off last October and bounced from the industry.
@drwho @jeneralist
Do you mean Moderna relocating assets (maybe)? -
The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.
Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.
A lot of people with herpes would be angry if they found out.
A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.
Jesus fucking christ
