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Jan. 24, 2022 - Epoch Times
21:48
Judge Rejects FDA Request, Gives Agency 8 Months to Produce Pfizer’s Safety Data | Facts Matter
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Good evening.
After several months of legal back and forth within the courtroom, with the FDA requesting up to 75 years to release all of the vaccine safety-related documents, well, just yesterday, a federal court has ruled against them.
Instead, the judge in the case, he said that the FDA has only eight months to release all of their Pfizer vaccine safety data, meaning that you and I might actually see this data by August of this year.
Meanwhile, over in India...
Well, their state medicine agency has just announced that they have discovered major safety concerns surrounding the COVID pill that is being produced by Merck, and they have now pulled it from their national protocols.
And those safety concerns are not minor, but instead, the agency said that they include things like defects in developing fetuses, permanent damage to cellular DNA, as well as damage to a person's bones as well as their muscles.
And this is all despite the fact that these Merck pills, they are not only approved for use here in America, but also the Biden administration has just signed a $2.2 billion deal to get them into more American hands.
Let's go through it all together.
This is your daily Facts Matter Update, and I'm your host, Roman, from the Epoch Times.
And now let's begin today's discussion by talking about the FDA. And to start with, on several previous episodes, we have already discussed how the FDA has been in the process of asking a federal court to give them somewhere between 55 years and 75 years to release all of their Pfizer vaccine safety data.
However, as of yesterday, their request has officially been denied.
That's right.
Just yesterday, a federal judge ordered that the FDA must produce all of the documents that are related to the Pfizer vaccine safety data in the span of just over eight months.
Essentially, they now have to make public all of the documents that they relied on when licensing the Pfizer vaccine, and they have to do so by either the end of August or the beginning of September.
Now, let me give you a bit of background on this particular case.
What happened was that several months ago, a medical transparency group called Public Health and Medical Professionals for Transparency, they made a Freedom of Information Act request against the FDA.
They essentially, they wanted the FDA to turn over all of their documents which were related to the authorization of the Pfizer vaccine.
Now, being an outsider, you might imagine that this request wouldn't take that long to fulfill.
That's because unlike a typical authorization process for a normal drug, which can take many years, the Pfizer vaccine was given FDA approval after only 108 days.
And so you might assume that with such a shorter time frame that they used to get everything ready for approval, they would be able to release all the documents that much faster.
However, the FDA responded to this group of doctors, the ones that were requesting these documents, and they claimed that it would take too long to release all these documents at once.
And so they wanted to negotiate on some kind of a schedule.
But after several months, the group of medical doctors and the FDA, they were not able to agree on a schedule, and so the group of doctors, they filed a lawsuit in federal court against the FDA. Here's part of the argument that the doctors were making in their lawsuit on why the disclosure was important, and more specifically, why it needed to be done in a timely manner.
Here's what they wrote, quote, It took the FDA precisely 108 days from when Pfizer started producing the records for licensure on May 7, 2021, to when the product was licensed on August 23, 2021.
We assume, as the FDA has stated, that it conducted an intense, robust, thorough, and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure.
The FDA now has an equally important task of making those documents available to the plaintiff in this case and the public at large in at least the same time frame.
Now, just to pause here for a quick moment.
Essentially, the argument that this group of medical doctors is making is that the FDA took only 108 days to conduct their entire review, and that all the documents pertaining to the review process should be made public for the sake of transparency.
And then they continue in the statement, By saying that being transparent is actually a requirement according to the FDA's own guidelines.
Here's what they wrote.
And that comes from the Code of Federal Regulations, subsection 601.51e.
And just to pause here again for a quick moment, this particular federal regulation that is being cited in this lawsuit, you can find it over on the FDA's website, and here's what it says in part.
After a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown.
And then when you scroll down a little bit, it lists some of the data that is to be disclosed, including all safety and effectiveness data and information, adverse reaction reports, We're good to go.
They said that since there are in total 329,000 pages of documents relating to the approval of the Pfizer vaccine, they proposed to release 500 pages of documents per month.
The FDA's rationale here was that this pace, meaning 500 pages of documents per month, it would give them enough time to redact any sensitive information in those documents.
Things, let's say, like people's full names, their home addresses, their birthdays, and so on.
However, the caveat is that if they were to actually release 500 pages a month, well, it would take them 55 full years to release all the documents.
Here's part of what the FDA said in their response to the lawsuit and what they sent to the judge.
Quote, However,
while the judge was still considering that request, well, last month, the FDA actually went back to that same judge and they renewed their request, saying that based on their new calculations, they would need an additional 20 years to release all the documents.
And so in total, as of last month, as of December, The FDA was requesting a full 75 years in order to release all of their documentation.
However, the lawyer who was representing the doctors in the case, he was not really buying the argument.
Here's in fact what he wrote as a response to the FDA's requests.
The entire purpose of FOIA, which is the Freedom of Information Act request, is government transparency.
In multiple recent cases, in upholding the FOIA's requirement to make the records promptly available, courts have required agencies, including the FDA, And
just yesterday, the federal judge in this case, he agreed with that argument.
Here's in fact what the judge wrote specifically as a part of his order, which was again released just yesterday.
Here, the court recognizes the unduly burdensome challenges that this FOIA request may present to the FDA.
But as expressed at the scheduling conference, there may not be a more important issue at the Food and Drug Administration than the pandemic, the Pfizer vaccine, getting every American vaccinated and making sure that the American public is assured that this was not rushed on behalf of the United States.
Accordingly, the court concludes that this FOIA request is of paramount public importance.
And then with this rationale as the basis, the judge then ordered that the FDA must produce over 12,000 pages on or before January 31st.
And then subsequently, the agency must, quote, produce the remaining documents at a rate of 55,000 pages every 30 days, with the first production being due on or before March 1st, 2022, until production is complete.
And then when you actually do the math here, when you divide up the total number of pages by 55,000 pages per month, you get about eight months, meaning that by either August, September, or by latest October, we should have all these documents publicly available.
And as you can imagine, the plaintiffs in the case were rather satisfied with this judge's order.
Here's in fact what the lawyer who's representing the Transparency Medical Group, here's what he released in a statement just yesterday.
This is a great win for transparency and removes one of the strangleholds federal health authorities have had on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program.
Issues which include waning immunity, variants evading vaccine immunity, and, as the CDC has confirmed, that the vaccines do not prevent transmission.
Now, we here at the Epoch Times, we did reach out to the FDA for comment on this court order, but we have yet to hear back.
Regardless, though, if you'd like to read more about this case, or if you'd actually like to sift through the documents that the FDA has already released in this particular case, I'll throw all that into the description box below this video for you to peruse at your own leisure.
And all I ask in return is that you take a super quick moment to smash, smash, smash that like button for the YouTube algorithm.
And now, let's head on over to India, where the new Merck COVID pill was just pulled from the national protocol.
What happened there was...
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And now Roman in the studio, back to you.
And now let's move on over to India, where just yesterday, the government there announced that they will not be adding the new Merck COVID pill to their national treatment protocol due to concerns over safety.
Now, specifically, what happened was that yesterday, the Indian Council of Medical Research, which is run by the state, it's essentially the top health research body in all of India, and they announced that they had become aware of major safety concerns regarding this new COVID pill, which is now causing them to pull their recommendation.
Here's specifically what the director general of this agency said in a statement.
Molnupiravir, which is the name of Merck's COVID pill, has major safety concerns including terogenicity, which are defects in a developing fetus, mutagenicity, which is a permanent and transmissible change in the structure of a person's genetic material, as well as muscle and bone damage.
If this drug is given, contraception must be done for three months as the child may have problems.
Now those are obviously very serious concerns.
So let's do this.
Let's back up for a quick moment, and I'll give you a bit of background on this COVID pill, which is particularly important given the fact that it is currently authorized to be used here in America.
Now to be specific, this COVID antiviral pill that is being produced by Merck, it is officially called Molnupiravir.
And this pill, it was created to combat cases of mild or moderate COVID. And the idea is that you take this pill shortly after getting diagnosed with COVID, and it's supposed to fight off the infection by essentially killing off the virus inside your body.
And according to the results of their Phase 3 trial, Merck said that this pill is very effective at cutting the rates of hospitalization, as well as the rates of death, by as much as half.
Although, again, that was the official statement that was released by Merck themselves, so take it with a grain of salt.
Regardless, though, this drug has both many proponents as well as many detractors.
For instance, the former commissioner of the FDA, he said this in a statement during an interview with CNBC. This is a phenomenal result.
I mean, this is a profound game changer to have an oral pill that had this kind of effect.
This magnitude of effect in patients who are at high risk, who are already symptomatic.
However, on the flip side, other people, particularly other scientific experts, they have said that they are very worried about the mechanics of how this pill actually attacks the virus.
That's because the way that this pill works Which is a process that's technically called lethal mutagenesis.
However, according to researchers who published this study right here, that you can find over, by the way, on the Journal of Infectious Diseases website, this method carries the potential for substantial risk because, quote...
The same mutagenic activity that impacts viral replication has the potential for incorporation and mutagenesis of host DNA, which they further said could contribute to either the development of cancer or to cause birth defects in an unborn baby.
In fact, the researchers, they said that that's exactly what happened during their testing of NHC, which is the compound that's created by this pill.
Here's in fact how one of these researchers summed up his findings in an interview with Barron's Magazine.
There is a concern that this will cause long-term mutation effects, even cancer.
Now, we here at the Epoch Times, we did reach out to Merck for comment, but we have yet to hear back.
However, here's a statement from Merck's CEO right after they submitted an application to the FDA for emergency use authorization.
However, even prior to them getting emergency use authorization, the Biden administration They already signed a $2.2 billion contract with Merck for these pills.
Specifically, the federal government agreed to purchase 3.1 million treatment courses of this drug for about $2.2 billion.
And according to Mr.
Jeff Zients, who is the White House's COVID response coordinator, he told reporters that if this pill was actually authorized, most of those treatment regimens could be distributed to states and municipalities by the end of next month.
And wouldn't you know it, just a few weeks after the Biden administration signed that deal, well, the FDA gave their approval.
In fact, just two weeks ago, they granted emergency use authorization to this Merck pill.
Here's in fact what the FDA said in the statement as they issued their approval.
As new variants of the virus continue to emerge, it is crucial to expand the country's arsenal of COVID-19 therapies using emergency use authorization.
Alright, there are actually two things that I believe are worth mentioning regarding this FDA emergency use authorization.
The first one is that the FDA based it on 1,433 patients who were treated with this COVID pill and they reported seeing a 3% reduction in moderate disease when the pill was given in mild cases.
So the reason I believe that's worth highlighting is that this claim of a 3% reduction in moderate disease is not bad, but it's a significantly lower claim than Merck was making, which is a 50% reduction in hospitalization as well as death.
And then the second point that I believe is worth highlighting is that the FDA's advisory committee, specifically the FDA's antimicrobial drugs advisory committee, they met back in November, they looked at all the evidence, and then they voted, and it was a very split decision.
Basically, 13 members voted for, while 10 members voted against granting emergency use authorization.
And the basic premise was the issue of safety.
And in the end, the people who voted for and ultimately won the vote, they said they agreed that the drug's benefit outweighed its potential risks, including the risks of potential birth defects.
Because some of the concerns that were raised during that meeting with this advisory committee was that the drug presented potential risks to pregnant women as well as their unborn children.
In fact, even with the emergency use authorization, this particular COVID pill, it's not advised to be given to either pregnant women or people younger than the age of 18 because this particular drug might impact bone and cartilage growth.
That's according to the FDA themselves.
Which actually perfectly circles us back to India.
Because here is what the Director General of the Council of Medical Research, here's what he said after he examined the data.
quote, we must remember that this drug has major safety and concerns.
The drug causes teratogenicity, or the ability to cause defects in a developing fetus, mutagenicity, or permanent transmissible changes in the structure of genetic material of cells, cartilage damage, and can also be damaging to muscles.
Furthermore, he also added that, quote, contraception would also have to be given to individuals who take the drug, regardless of whether they are male or female, because the child born could be problematic with teratogenic influences.
He further said that the WHO has not included it.
The UK has not included it.
As of now, the current recommendation stands that it is not part of the National Task Force treatment.
Likewise, this type of reaction is not only coming out of India, but also France as well.
Because about two weeks ago, the French government, they canceled their order of these Merck COVID pills, although they cited a different reason.
They did not cite the problem with unborn children or potential problems with muscle or bone growth.
But instead, they said that data that was released back in late November, it suggested that the drug was markedly less effective than previously thought, reducing hospitalizations and deaths in its clinical trial By about 30% rather than by about 50%, which Merck was claiming initially.
And this was then a quote by the director of the health agency in France.
Quote, And therefore, using this reasoning as their basis, the French government canceled an earlier contract that they placed for 50,000 doses of the Merck COVID pills.
So that is what's happening in France and over in India.
However, here in the United States, it's a much different picture.
Because as we mentioned earlier, the FDA just two weeks ago gave emergency use authorization to Merck so that they can begin selling these Merck COVID pills.
And with the U.S. government just placing a $2.2 billion order, well, these pills are about to begin to be rolled out to the citizens of this country.
So we're here at the Epoch Times.
We reached out to both the federal government as well as to Merck to give us a comment on what they think about these developments around the world.
But we have yet to hear back.
Regardless, though, based on what the FDA Advisory Committee discussed during that meeting that we talked about earlier, well, it seems like they are very much aware of all the problems that...
Could potentially come from the use of this pill, which is exactly why they don't recommend anyone below the age of 18 to use it, or why they don't recommend pregnant women to use it.
And so it looks like they weighed the pros and the cons, and they believe that the benefits of the pill outweigh any potential risks.
And so we'll just have to see how it all plays out.
And if either Merck or the federal government gets back to us, I will let you know right away.
Otherwise, Roman in the studio, back to you.
If you'd like to read more about some of the studies behind this new Merck pill, or about its status either here in America, over in India, or in other countries, I'll throw the links to all those articles into the description box below this video, and I'll ask in return is that you take a super quick moment, if you haven't already, to smash, smash, smash that like button for the YouTube algorithm.
And now, since you've completed this episode of Facts Matter, I would highly recommend that you go on over to Epic TV and check out an awesome episode of Truth Over News, where Jeff and Hans explore the question of how Dr.
Fauci and Dr.
Collins silence scientists who don't agree with them.
Here's a trailer for that episode.
Recently released emails reveal an attempt by two of the U.S. government's most senior officials to silence acclaimed scientists who did not toe the official line on COVID-19.
The October 2020 emails between Anthony Fauci and his boss Francis Collins highlight the behind-the-scenes efforts to take down the authors of the Great Barrington Declaration.
Fauci and Collins have demonstrated a history of colluding with big tech and the corporate media to censor views that run counter to their personal interests.
The efforts by Collins and Fauci to silence American scientists serves as a chilling reminder of the extent and intensity with which First Amendment rights have been undermined in the pandemic era.
If you'd like to check out that awesome episode, as well as all the other phenomenal content over on Epic TV, I'll throw the link to it.
It'll be right there at the very top of the description box.
I hope you click it.
I hope you check it out.
I hope you subscribe.
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