Sunday, June 13, 2021

SIM cards to be blocked for those refusing vaccine, says Punjab govt. Venues too/ Pakistan today

Pakistan's Punjabis must vaccinate, or lose their phone and internet access!  Yet Pakistan's Covid cases are way down, like ours, at the lowest level since February.

WHY is it so important to vaccinate everyone?

Are the shots the essential step to "vaccine passports"?

Is the vaccine passport necessary to institute a full surveillance state, digital cash, and gain total control over the population?  How does 5G fit?

I'd love it if someone has a better explanation.

The only other one I can come up with is that there is now or in the future going to be something nasty and unanticipated in those shots.  Hope I'm wrong.  

From Pakistan Today:

The SIM cards of any citizen refusing to get vaccinated against the coronavirus will be blocked, said an official of the provincial government.

This step was taken in an attempt to drive up the vaccination drive and accelerate the procedure for getting the country vaccinated. This ties into the fact that walk-in vaccinations for all adults will be open from June 12.

“Final decision has been taken to block the mobile SIM cards of people not getting vaccinated,” Punjab Specialised Healthcare Department spokesman Syed Hammad Raza said.

A high-level meeting chaired by Punjab Health Minister Dr Yasmin Rashid also decided to set up mobile vaccination camps outside major shrines in the province, and fully open businesses in all districts where at least 20 per cent of the population has been vaccinated.

Vaccinated people will be allowed to go to cinema halls and restaurants and marriage halls will be opened. People suffering from terminal illnesses like HIV/AIDS and cancer will now be vaccinated on priority, according to the spokesperson...

Saturday, June 12, 2021

INDIA forces unvaccinated to wear skull and crossbones bibs; and removed recommendations for ivermectin and hydroxychloroquine

India under Modi is a testing ground.  Remember 
how Modi banned high value Rupee notes to force 
Indians to use digital money.  It can happen here.--Nass
Skull and Crossbones Sign Given to Unvaccinated in Rural India
https://www.usnews.com/news/world/articles/2021-06-10/skull-and-crossbones-sign-given-to-unvaccinated-in-rural-india

LUCKNOW, India (Reuters) - Police in rural India have made some citizens who have not been vaccinated against the coronavirus wear signs with a skull and crossbones, the universal symbol for danger, stoking anger in a country where shots are in short supply.

Officers in the Niwari district of central Madhya Pradesh state said they introduced the policy to encourage more vaccinations.

"Watching the low vaccination rate in our district we decided to honour the people who got vaccinated, but then we also found a large number of people who were not vaccinated," Santosh Patel, a sub-divisional police officer posted in the Prithvipur block of Niwari district, told Reuters on Thursday.

"So to teach them a lesson and encourage them to get vaccinated, we administrated an oath to get them inoculated as soon as possible."

Those who were not vaccinated were given a skull and crossbones sign saying "Do not come near me, I am not vaccinated. Please stay away from me," according to Patel and video footage from the district. Some people were seen wearing the signs taped to their chest.

The policy has provoked anger online, with social media users calling it an "insult" and "stigmatising".

Around 14% of residents in Madhya Pradesh have had one inoculation against coronavirus, with vaccination rates in rural areas like Niwari among the lowest anywhere in the country.

 https://www.tribuneindia.com/news/nation/new-treatment-guidelines-drop-ivermectin-zinc-vitamins-hydroxychloroquine-265244

India on Monday issued a new clinical protocol for Covid treatment and dropped all commonly used treatments for mild patients of the infection, including antibiotics, hydroxychloroquine (HCQ), ivermectin and antiviral drug favipiravir.

No antibiotic for mild cases

  • No antibiotics or antiviral drug favipiravir for mild patients
  • No steam inhalation (people doing this in excess)
  • Hydration, good diet, positive mindset, social connection important for recovery
  • Remdesivir, tocilizumab use only in severely ill cases, as per fresh DGHS norms

WHO chief scientist Soumya Swaminathan today hailed the new evidence-based guidelines developed by the Director General of Health Services (DGHS) who said mildly ill Covid patients would be fine with just paracetamol, cough syrup and budesonide inhalation and need not be prescribed any antibiotics or major drugs at all.

This means the currently in use and much prescribed HCQ, favipiravir, ivermectin, azithromycin, doxycycline, zinc and vitamins are not required clinically and have no evidence of benefit.

The DGHS advice, however, is at variance with the ICMR advisory, which recommends both ivermectin and HCQ in mild cases. For asymptomatic patients, the new guidelines do not even recommend a blood test or any drugs and clarify “no investigation and no medications are needed at this stage.”

The Co-Conspirators have received incredible rewards for their treachery. Let's start with Rick Bright

Rick Bright

Immediately after Rick Bright was transferred out of his position as head of BARDA and sent to the NIH, he started making a huge fuss.  The April 22, 2020 NYT discribed his statements:

“While I am prepared to look at all options and to think ‘outside the box’ for effective treatments, I rightly resisted efforts to provide an unproven drug on demand to the American public,” Dr. Bright said. He went on to describe what he said ultimately happened: “I insisted that these drugs be provided only to hospitalized patients with confirmed Covid-19 while under the supervision of a physician.”

By May 14, 2020 Bright was already before Congress, supposedly as the good guy whistleblower who was trying to get things right for the pandemic against huge odds:

Bright told lawmakers Thursday he and other federal health officials had “worked hard” to resist pressure to allow a significant increase in access to hydroxychloroquine, and instead scaled that back to allowing an emergency use authorization but only “with strict guidelines.”

But he said his “concerns were escalated when I learned that officials were pushing to make that drug available outside that emergency authorization.”

“When I spoke outside of the government and shared my concern with the American public, that I believe was the straw that broke the camels back and escalated my removal,” Bright said.

He later said, “The highest priority we have is safety.”

... Bright’s lawyers said last week that the OSC had told them the investigation already had found evidence that Bright was ousted as head of a health agency for pushing back against increasing use of  hydroxychloroquine...

HHS, in an emailed statement, said, “Rick Bright was transferred from his role as BARDA director to lead a bold new $1 billion testing program at NIH, critical to saving lives and reopening America.”

“Mr. Bright has not yet shown up for work, but continues to collect his $285,010 salary, while using his taxpayer-funded medical leave to work with partisan attorneys who are politicizing the response to COVID-19,” the statement said.

“His whistleblower complaint is filled with one-sided arguments and misinformation. HHS is reviewing the complaint and strongly disagrees with the allegations and characterizations made by Rick Bright.”

HHS also said that it was under Bright’s leadership that BARDA identified chloroquine and hydroxychloroquine as potential Covid-19 treatments.

“Rick Bright was the sponsor of getting hydroxychloroquine and praised his team for acquiring the drugs,” HHS said.

Bright's reward?  He was made a senior vice president of the Rockefeller Foundation, after refusing to show up for work at NIH.  And who raved about him on the Rockefeller Foundation website?  None other than Jeremy Farrar and Michael Ryan.  I have not written about Ryan so far, but he is another co-conspirator in the efforts to suppress appropriate treatments, poison patients with excess doses of HCQ and prolong the pandemic, as Executive Director of the World Health Organization's Health Emergencies Programme.

From the Rockefeller Foundation:

“If there is something we have learned throughout the COVID-19 pandemic and other high impact epidemics, it is that pandemic preparedness and response cannot be advanced with a siloed approach,” said Dr. Mike Ryan, Executive Director of the WHO’s Health Emergencies Programme. “Few people bring the full package to the table: profound scientific and public health expertise, years of outbreak response experience, a private and public sector background and a collaborative, innovative, and out-of-the-box mindset. Rick Bright combines all these qualities. His leadership will be an enormous asset to The Rockefeller Foundation and to the global health community.”

Dr. Bright resigned from government service in protest over the Trump administration’s approach to handling the Covid-19 pandemic, specifically over the level of political interference in science and the spread of inaccurate information that he said was ‘dangerous, reckless and causing lives to be lost.’

“I’m delighted that Dr. Rick Bright has been appointed as Senior Vice President of Pandemic Prevention and Response at The Rockefeller Foundation,” said Dr. Jeremy Farrar, Director of Wellcome. “The Covid-19 pandemic has highlighted the human and economic costs of epidemics and the fact that we need to be better prepared to identify and respond to emerging infections. Dr. Bright is a leading figure in global health with a wealth of experience, and we look forward to working with him over the coming years.”

Bright's job at Rockefeller is to work on future pandemic planning.  Need I say more?

Reposting this MUCH EXPANDED version of my live blog of the FDA VRBPAC meeting on June 10

 https://www.youtube.com/watch?v=70Xhn3K9SlQ&ab_channel=U.S.FoodandDrugAdministration

1.  Almost every member of the advisory committee earns money for their work on vaccines.  However only one acknowledged a financial conflict of interest, which was minor. Most of the VRBPAC members at today's meeting are not actually regular members of the VRBPAC committee. It looks as if the Covid vaccine meetings have been stacked with mostly yes-men and women. By my count 10 members are regulars and 12 are temporary members, brought in to help stack the deck.

2.  A Merck employee is a non-voting member today.

3.  Stanley Perlman is a member today.  He signed the Lancet March 7, 2020 Correspondence that was intended to cover up a lab origin and enforce the natural origin theory of Covid!

4.  Eric Rubin, editor-in-chief of the NEJM, is a member today.  He published a fabricated study by the Surgiphere group, the same group that published the fabricated Lancet study that said the chloroquine drugs kill. His journal has been very kind to Covid vaccines.  And today he had the chutzpah to say that we don't even know if the mRNA vaccines cause myocarditis. 

5.  CDC did its own unpublished study to try and jack up the risk for kids of hospitalization for Covid.  They were caught by Dr. Meissner who points out that the current rate is 0.4/million, very low, and the risk of the vaccine needs to be lower than this. Later, Dr Meissner mentioned a 12 year old admitted to his hospital last weekend with myocarditis, 2 days after his second shot.  When Meissner began to beg the others to pay attention to the risks, his mike was cut off.

6.  CDC admits that the data are mixed regarding transmission and cases in kids. Having said that, they present their own (apparently skewed and definitely unpublished) data claiming that children get infected and transmit at the same rate as adults.  They claim that 0-4 year old children have an over 85% rate of symptomatic illness, which is different than what everyone else  has found. 

7.  Seroprevalence for Covid was said to be 27% in children, using antinucleocapsid antibodies (so vaccinees won't test positive), higher than all older age groups. My question:  CDC is presenting serology data but elsewhere claims it is unreliable at the individual level, whereas it can be used at the population level. 

Why can CDC use these data to makes its points but I can't use the same test to travel, cross a border, or attend an event?

8.  Meissner pointed out that the numbers CDC is using re pedi hospitalizations is from April and currently the number is only 1/4 as great. The Epoch Times then went and surveyed doctors about the issue of teenage hospitalizations, and obtained a consensus that CDC lied.

9.  Dr Stokly at CDC said there is no federal age of consent, and it is determined by the States.  Yet currently municipalities are determining that 12 year olds can give consent in states that do not allow it--but of course this was omitted from her talk. Yet the only way that could happen is for CDC and FDA to give those cities (San Francisco, Seattle and Philadelphia for sure) a green light.

10.  39% of 16-17 year olds have received at least one dose of vaccine, per CDC.

11.  Dr. Steve Anderson claimed there are "no safety signals" currently for the 16 prespecified adverse events, which include myocarditis and thrombosis.  And he had a chart to demonstrate this.  Duh?  What about the fact we know risks are elevated for thrombosis and myocarditis?  Well, they are going to study that in the future.  Wouldn't the absence of a safety signal that has already been found to exist in multiple countries indicate your surveillance system is not working as it should?

12.  Dr. Shimabukuro noted there are 789 VAERS reports of myopericarditis.  475 occured in teens and people in their 20s. Most occur after dose 2.  Over 70% are in males.  The median age after dose 2 is 24.  There are about 8 times as many cases after dose 2 as after dose 1.  I'd call that a pretty clear signal, Dr. Anderson. AND there has not even been time for a second dose in the vast majority of 12-15 year olds, for whom the vaccine was authorized less than 4 weeks ago.

13.  What databases will be used to assess safety in those under 18?  The first answer was just the VSD and BEST, per FDA, while last we heard BEST was still being tested and inoperational.  Later, in response to a question from Chair Arnold Monto (in which I think Monto was trying to clean up a previous answer he knew was incorrect), Anderson said just VAERS and VSD would be used to assess safety in younger children. What happened to all those other databases CDC was going to use?  Disappeared, eh?  

Later, Dr. Kim asked if there were plans to "include millions of other safety surveillance opportunities?" Anderson dodged, saying that "there were other electronic health records systems... we already showed this to your committee..." and then concluded, "we can reshare that slide so you have it."

Dr. Gans asked, "when we add in all the safety surveillance systems what % of kids will be accounted for?"  Anderson was gobsmacked by this simple question whose answer he must know.  Yet he very slowly answered, "I'll ask my staff."

Then Gans asked, "why not be proactive? All the autoimmune side effects are not on the solicited list of adverse events.  Can we add them?" At this point Anderson started stuttering. He eventually said "we are considering doing something similar." BTW, I have found the "we are considering" answer to be standard bureaucrateez when the real answer is "Hell no, do you want us to incriminate ourselves by showing there are more problems than we are willing to acknowledge?"

And then the expected happened:  Monto tried to end the discussion. Shimabukuru tried to make it okay, jumping in to say he would be happy to work with his FDA colleagues on this.  That gave Dr. Meissner the opportunity to ask him the rates of thrombosis with thrombocytopenia in young women, and myocarditis in kids.  Then it was Shimabukuru's turn to stutter.  Finally he said it is too early to say.  This appeared to be another example of not wanting to incriminate himself with a lie, while he doesn't want to tell what he knows.  The reason is that having this number would permit the committee to perform a risk-benefit comparison (Covid hospitalization rate vs vaccine myocarditis rate) which would probably sink both an EUA and licensure in children.

Meissner didn't stop. "Shouldn't this risk be included in the Informed Consent?" he asked. Shimabukuru said his slides had the info (but the info would not pass his lips). He then asserted that CDC is committed to transparency and transparency in communication. I think this meant, "Hell no, we are not adding this to any patient information sheet."  

14.  The VSD database at this point only includes 121 adolescents who received a second dose.  Guess that is the excuse why the myocarditis carnage couldn't be identified by FDA and CDC before this meeting. Is that why the meeting was held now, before additional databases with tens of millions of enrollees were added to BEST data in mid June?  Because then it would be harder to claim they didn't know about the serious adverse events?

15.  It was claimed "the data" only show 1/60,000 doses develops myocarditis.  But the Israeli data in young men showed 1/6,000 doses, according to (I think) Dr. Meissner.  Dr. Dror Mevorach, who did the study for Israel, says the rate of myocarditis in young men is 5-25 times the baseline rate. Some say the rate is 1/2,500.

16.  Dr. Anderson or Dr. Shimabukuru said "at least 81% of myocarditis cases made a full recovery."  But they only have followup on less than half the cases.  No one told us how many had died. 

17. After presentations on the data requirements for an EUA and licensure in different age groups, which were set to rely on "immunobridging" even though the antibody test used apparently fails to provide a direct extrapolation to immunity, Monto declared, "We're not going to have the time to answer everyone's questions."

18.  Kurilla asked whether the vaccines, made from a strain collected 18 months ago that is no longer in circulation, is the right one given current variants. Monto cut that right off, saying "We're not talking about variants, because it's a global issue." Which made no sense, but got the group away from any consideration of variants. This was important, because further discussion would probably reveal the fact that current vaccines have poor efficacy for some variants, and should perhaps be replaced with better targeted vaccines.  In fact, wasn't the ability to easily and cheaply switch mRNA midstream to target new variants the rationale to use mRNA vaccines in the first place?

19.  Dr. Nelson pointed out that since the trial populations were very small, would FDA correspondingly pay attention to smaller safety signals than usual? By vaccine or by class?  I thought it was a great question. [Michael Nelson used to care for anthrax vaccine-injured soldiers at Walter Reed and I have previously been impressed with his clinical work.] Doran Fink played it safe by providing a meaningless response, saying FDA would "follow the data."

 20.  The meeting is nearly over, and not a single person has mentioned that the spike protein itself might have toxicity.  

21.  Nor has anyone pointed out that the animal studies (required before FDA gives permission for human studies) were not done.  We do not know the pharmacokinetics in a human or animal body of the spike protein, the S1 protein, the mRNA, other proteins that may be produced, and the multiple components of the lipid nanoparticle. Pfizer injected 2 of the 4 lipids into rodents and called it good. Furthermore, I have seen no evidence regarding the duration during which the spike protein is produced, and what happens to cells that produce it. A study out of Harvard showed it can be produced for at least two weeks.

22.  No one mentions what might be causing menstrual abnormalities.  No one has discussed blood clots outside the very limited perspective of adult women age 30-50.

23.  Amanda Cohn, MD from CDC is a member of VRBPAC.  She was one of three CDC physicians who lied to Congressman Tom Massie regarding CDC's recommendation to vaccinate people who have recovered from the disease. Another person who lied was deputy director Schuchat, who has since been fired by Director Walensky.  Of course, Walensky has recently been lying about the number of teens hospitalized due to Covid. Hard to find an honest doc at CDC it seems. Walensky promised she would always tell us the truth in a prominent NY Times Opinion piece in January. Sad.

Thinking about the dishonest CDC physicians and committee member conflicts of interest, I forgot to mention that Dr. Melinda Wharton is also a temporary member of today's committee.  She is probably the top person at CDC whose job is to coverup vaccine safety problems.  For example, here is a 2004 Congressional testimony she gave, in which she cites the "Denmark data" CDC cooked up with a Denmark contractor.  Their collusion is described in a book by James Grundvig.  The "Denmark data" was faked by Poul Thorsen in order to claim that thimerosal in vaccines was not dangerous.  Psychiatrist Thorsen, who is now a fugitive wanted by DHHS, has been accused of multiple crimes, including forgery, stealing $900,000 from CDC and stealing from his university in Denmark.  Naturally, DHHS forgot to add his scientific misconduct. Yet CDC still cites his "study" as the basis for denying thimerosal injuries. UPDATE:  Actually, I just looked this up again; I had made this claim in a 2019 testimony and checked the link then, when CDC was still citing Thorsen.  Today I see CDC has removed the Thorsen-named publications from this graphic. But they include the tainted Danish research.  And include this paper about it, whose last author is Thorsen's then-lover and CDC employee, Diane Simpson.

24.  Phyllis Arthur, from the industry association BIO, was given 10 minutes to provide the "industry perspective." Why was she there?  Why was Merck there? She made the disease in kids out to be pretty bad.  She claimed kids were needed for herd immunity, which was disputed in the WaPO and relies on the. claim that children readily spread Covid, which is at least debatable. Finally, she wanted to know whether FDA would help industry market Covid vaccines to the world, or in her words, "assure global alignment for pediatric Covid vaccine programs."

25.  Peter Doshi provided a public comment which was, as usual, astute. I especially liked his reminder that a median 2 months of follow-up being used to issue an EUA was not likely to detect long-term adverse effects of vaccination.  It took 9 months to identify narcolepsy as a side effect of Pandemrix vaccine, and 4 months for Israel to identify myocarditis as a side effect of the Pfizer vaccine. Finally, he pointed out that if FDA does not have a high bar for EUAs/licenses, the point of regulation is lost.

26.  Several members asked about studies testing different doses, or a single shot in children, but not a single presenter from CDC or FDA would talk about lower doses. Very curious. Surely the FDA does not plan to give children, who respond with higher antibody levels to the vaccines, adult doses, despite their smaller size and weight than adults.  Why did FDA refuse to discuss this?

27.  Gans asked, is anyone looking at risk factors for myocarditis (or other adverse events)? CDC's Shimabukuru stuttered and blathered.  FDA's Anderson pointed out that he has not identified a signal yet.  (In other words, how could he be expected to look into risk factors for side effects when his fabulous surveillance systems have not found any side effects yet!). Then he backed up just a bit, adding, "but your question is a valid one."  Yup, it may be valid, but the FDA isn't going near it.

28.  Dr. Offit pointed out that we vaccinate for polio, but we have not had a case of polio in the US since the 1970s, so why not keep vaccinating for Covid even after it's gone?  Offit is wrong about polio.  We had only vaccine-induced polio cases between 1979 and 1999, at which point oral polio vaccines were taken off the market and replaced with safer, but less effective killed polio vaccines.

29.  FDA's Doran Fink pushed back against longer-term followup of trial subjects, and larger trials.  Instead, he claimed, what we need is post-marketing surveillance.

30.  The statistician Dodd, a new member, pointed out that it was meaningless to talk about how large the pedi trials whould be when you cannot make that calculation until you know what you are trying to look for.  I imagine the docs who had been throwing out numbers felt sheepish, since she is of course correct.  That ended discussion of trial size.

31.  Things ended quickly after that, since FDA/Dr. Monto had determined the meeting would cease at 3:30. A few intelligent comments were made, ignored, then Peter Marks, head of FDA's Center for Biologics hopped on to emphasize how terrible the disease was in children. He lied about the death rate, choosing to use the invalid statistic (which even CDC disputes) of only those who had a valid positive test, which is a bit more than 1 million Covid cases in the 11-17 age range.  (However, CDC estimates that over 1/3 of the country has had Covid.  Extrapolating that to the 11-17 age group yields over 9 million cases in that age group.) By choosing a false metric, Dr. Marks' mendacity enabled him to claim the death rate was very high in teenagers, which is simply not true.

Here are the real CDC numbers.  Between Jan 1 and March 31, 2021, 204 children aged 12 through 17 were hospitalized for Covid.  One hundred forty-four of them had pre-existing conditions.  None died.  Their average length of stay was 2.4 days. 

So, of 24 million children in that age group, 60 healthy children had brief hospitalizations for Covid and no deaths during our highest Covid incidence period.  

Now here are the total number of US Covid hospitalizations on the dates January 1, March 31 and June 9, 2021.  These come from the NY Times.

Jan 1, 2021            130,000

March 31, 2021       43,000

June 9, 2021            20,000

What this tells you is that during the highest months of Covid cases and hospitalizations (which is the time period CDC chose for its analysis), only 20 otherwise healthy children needed a brief hospitalization for Covid per monthin the entire country.  There was not a single death.  And now we are at roughly a quarter of those rates. Another way of looking at this is that during those entire 3 months, every US state and territory had about one--ONE--healthy kid require hospitalization for a couple of days for Covid. That should cast Peters Marks' and Rochelle Walensky's claims of dire Covid risk for teenagers in the fairy tale category.  And it should make clear that Walensky and Marks are the wicked witch and wicked wizard, who would willingly injure children for a few pieces of silver and a government job on their resumes.

For this minuscule risk the US government wants all our children vaccinated, despite heart inflammation that seems to occur at 5-25 times the expected rate after mRNA vaccinations, and may well leave your child with permanent heart damage.  Why is there a complete lack of information on the longterm side effects that may ensue? Because FDA regulators didn't ask the manufacturers to look.

This is not medicine, this is medical fascism.

32. Five months ago, at the December 10 meeting of the VRBPAC, we were given an estimate of total US Covid cases at the time, which was over 50 million.  Or about 3 or 4 times the rate of positive tests and diagnoses then.

However, today there were no estimates given by the presenters.  The number of cumulative US Covid cases, according to today's federally employed physicians, had dropped from over 50 to around 33 million cases.  I guess they think it is a better number to help push vaccinations, rather than admitting that perhaps 3 or 4 times that many are already immune. This went on while the CDC website on June 11 estimates there have been 114.6 million US cases of Covid.

Now, what was the purpose of today's meeting?  I suspect it was to get a few "experts" from outside the FDA on record as being in favor of quick licensure. Here is my prediction, for which I have no inside info:  FDA will license the Covid vaccines for children and adults on the same day in early August, in order to cover everyone's mandates for colleges and schools.  Unless there is an uproar regarding side effects, the vaccines are likely to be placed on the childhood schedule, which is required in order for the manufacturer to skirt liability for injuries once the vaccines are out of EUA status.

Today, the third member of a sister FDA drug advisory committee quit.  It turns out that every member of that committee had voted against approving a $50,000/year drug for Alzheimer's, and then the FDA went ahead and licensed it anyway. One of those who quit called the advisory committee process a "sham process."

Aaron Kesselheim, a well known Harvard professor of drug regulation, was the third to publicly leave the committee.  As the WSJ reported

 “Th[e] pivotal question was not discussed at the advisory committee meeting, and its premise was specifically excluded from discussion,” he wrote in his letter of resignation to FDA Acting Commissioner Janet Woodcock.

Calling the agency’s decision a “debacle,” Dr. Kesselheim said the move “will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation and the affordability of the healthcare system.”

The iron hands of controllers Janet Woodcock (here is more on her from June 12) and Marion Gruber (Head of FDA's Office of Vaccines Research and Review) have to go. FDA's brazen disregard of the truth, the data and the science may soon have Americans asking why we spend $3.2 billion a year to fund FDA. 

This meeting brought some Bob Dylan lyrics to mind.  Poor Doran Fink, FDA's chief vaccine flunky.  He's got an MD and a PhD and his dishonorable vocation is to keep a lid on the truth. Same goes for Peter Marks.  Poor Drs. Shimabukuru and Steve Anderson.   How much are they paid for their malfeasance? Have they no shame?

Twenty years of schoolin' and they put you on the day shift...

Johnny's in the basement 

Mixing up the medicine 

I'm on the pavement 

Thinking about the government...


You don't need a weather man 
To know which way the wind blows

Nope.  All you need are a few hours at an FDA meeting.

I don't know what this means but "New discovery shows human cells can write RNA sequences into DNA" is worth looking into/Phys.org

 https://phys.org/news/2021-06-discovery-human-cells-rna-sequences.html

We already knew that under certain conditions (including infection with HIV, which contains a reverse transcriptase) cells could "write" RNA into DNA.  But I didn't think it happened that often.  

However, according to this paper, a DNA polymerase that is normally present in mammalian cells has this ability too.

If so, it could really put a dent into the injection of mRNA into humans.  Stay tuned.

Friday, June 11, 2021

The Peril of Politicizing Science/Krylov

Please go read the whole article.  The history is beautifully detailed and the implications are crtitically important. A fabulous read--Meryl

https://pubs.acs.org/doi/10.1021/acs.jpclett.1c01475

It’s a beautiful thing, the destruction of words.

Don’t you see that the whole aim of Newspeak is to narrow the range of thought? In the end we shall make thoughtcrime literally impossible, because there will be no words in which to express it.

–George Orwell, 1984

I grew up in a city that in its short history (barely over 150 years) had its name changed three times.(2,3) Founded in 1869 around a steel plant and several coal mines built by the Welsh industrialist John Hughes, the settlement was originally called Hughesovka (or Yuzovka). When the Bolsheviks came to power in the 1917 Revolution, the new government of the working class, the Soviets, set out to purge the country of ideologically impure influences in the name of the proletariat and the worldwide struggle of the suppressed masses. Cities and geographical landmarks were renamed,(4) statues were torn down, books were burned, and many millions were jailed and murdered.(5) In due course, the commissars got to Yuzovka, and the city was stripped of the name of its founder, a representative of the hostile class of oppressors and a Westerner. In modern terms, Hughes was canceled. For a few months, the city was called Trotsk (after Leon Trotsky), until Trotsky lost in the power struggle inside the party and was himself canceled (see Figure 1). In 1924 the city became the namesake of the new supreme leader of the Communist Party (Stalin), and a few years later renamed to Stalino. My mother’s school certificates have Stalino on them. Following Stalin’s death in 1953, the Communist party underwent some reckoning and admitted that several decades of terror and many millions of murdered citizens were somewhat excessive. Stalin was canceled: his body was removed from the Mausoleum at Red Square (where it had been displayed next to Lenin’s); textbooks and encyclopedias were rewritten once again; and the cities, institutions, and landmarks bearing his name were promptly renamed. Stalino became Donetsk, after the river Severskii Donets.

Figure 1

Figure 1. Soviet history was constantly revised to keep up with the current party line. Historic photographs were routinely airbrushed and textbooks rewritten to obliterate the canceled.(1) Left: Lenin speaking in Moscow to Red Army soldiers in 1920, with Leon Trotsky and Lev Kamenev standing to his left side, on the steps to the right. Right: Same scene, with Trotsky and Kamenev airbrushed out, after they were canceled. Once the heroes of the Revolution, they had become traitors and enemies of the people. (Photograph May 5, 1920, by G. P. Goldshtein. Part of the David King Collection. Purchased from David King by Tate Archive 2016. Photo copyright Tate.)

I came of age during a relatively mellow period of the Soviet rule, post-Stalin. Still, the ideology permeated all aspects of life, and survival required strict adherence to the party line and enthusiastic displays of ideologically proper behavior. Not joining a young communist organization (Komsomol) would be career suicide—nonmembers were barred from higher education. Openly practicing religion could lead to more grim consequences, up to imprisonment. So could reading the wrong book (Orwell, Solzhenitsyn, etc.). Even a poetry book that was not on the state-approved list could get one in trouble.

Mere compliance was not sufficient—the ideology committees were constantly on the lookout for individuals whose support of the regime was not sufficiently enthusiastic. It was not uncommon to get disciplined for being too quiet during mandatory political assemblies (politinformation or komsomolskoe sobranie) or for showing up late to mandatory mass-celebrations (such as the May or November demonstrations). Once I got a notice for promoting an imperialistic agenda by showing up in jeans for an informal school event. A friend’s dossier was permanently blemished—making him ineligible for Ph.D. programs—for not fully participating in a trip required of university students: an act of “voluntary” help to comrades in collective farms (Figure 2).

Figure 2

Figure 2. Fourth-year chemistry students from Moscow State University (the author is on the right) enjoying a short break in the potato fields during mandatory farm labor, ca. 1987. The sticks were used as aids for separating potatoes from the mud.

Science was not spared from this strict ideological control.(6) Western influences were considered to be dangerous. Textbooks and scientific papers tirelessly emphasized the priority and pre-eminence of Russian and Soviet science. Entire disciplines were declared ideologically impure, reactionary, and hostile to the cause of working-class dominance and the World Revolution. Notable examples of “bourgeois pseudo-science” included genetics and cybernetics. Quantum mechanics and general relativity were also criticized for insufficient alignment with dialectic materialism.

Most relevant to chemistry was the antiresonance campaign (1949–1951).(7) The theory of resonating structures, which brought Linus Pauling the Nobel prize in 1954, was deemed to be bourgeois pseudoscience. Scientists who attempted to defend the merits of the theory and its utility for understanding chemical structures were accused of “cosmopolitism” (Western sympathy) and servility to Western bourgeois science. Some lost jobs. Two high-profile supporters of resonance theory, Syrkin and Dyatkina, were eventually forced to confess their ideological sins and to publicly denounce resonance. Meanwhile, other members of the community took this political purge as an opportunity to advance at the expense of others.(7,8) As noted by many scholars,(7,8) including Pauling himself,(9) the grassroots antiresonance campaign was driven by people who were “displeased with the alignment of forces in their science”.(7) This is a recurring motif in all political campaigns within science in Soviet Russia, Nazi Germany, and McCarthy’s America—those who are “on the right side” of the issue can jump a few rungs and take the place of those who were canceled. By the time I studied quantum chemistry at Moscow State University, resonance theory had been rehabilitated. Yet, the history of the campaign and the injustices it entailed were not discussed in the open—the Party did not welcome conversations about its past mistakes. I remember hearing parts of the story, narrated under someone’s breath at a party after copious amounts of alcohol had loosened a tongue.

Fast forward to 2021—another century. The Cold War is a distant memory and the country shown on my birth certificate and school and university diplomas, the USSR, is no longer on the map. But I find myself experiencing its legacy some thousands of miles to the west, as if I am living in an Orwellian twilight zone. I witness ever-increasing attempts to subject science and education to ideological control and censorship. Just as in Soviet times, the censorship is being justified by the greater good. Whereas in 1950, the greater good was advancing the World Revolution (in the USSR; in the USA the greater good meant fighting Communism), in 2021 the greater good is “Social Justice” (the capitalization is important: “Social Justice” is a specific ideology, with goals that have little in common with what lower-case “social justice” means in plain English).(10−12) As in the USSR, the censorship is enthusiastically imposed also from the bottom, by members of the scientific community, whose motives vary from naive idealism to cynical power-grabbing...

* Click the link above for the rest

FDA gives Emergent BioSolutions a consolation prize: it must throw out 60 million vaccine doses but can sell 10 million, which will be labeled as failing GMP standards/ NY Times

Now this is a really odd FDA decision.  FDA is acknowledging that the 10 million doses it is authorizing is adulterated.  But adulterated doses can't be sold.  But EUA products don't generally get sold, except to the US government.  I am scratching my head.  I thought all these doses were already bought and paid for, by the taxpayer.

And there seem to be another 100 million doses about which FDA has not made up its mind.

This echoes FDA's decision last week to license a very expensive but ineffective Alzheimer's drug, after its advisory committee unanimously voted against it.

We always knew FDA was a political organization.  But now, without Biden having appointed anyone to its helm, its decisions are wilder than ever.

From the NY Times today:

WASHINGTON — Federal regulators have told Johnson & Johnson that about 60 million doses of its coronavirus vaccine produced at a troubled Baltimore factory cannot be used because of possible contamination, according to people familiar with the situation.

The Food and Drug Administration plans to allow about 10 million doses to be distributed in the United States or sent to other countries, but with a warning that regulators cannot guarantee that Emergent BioSolutions, the company that operates the plant, followed good manufacturing practices.

The agency has not yet decided whether Emergent can reopen the factory, which has been closed for two months because of regulatory concerns, the people said.

The Johnson & Johnson doses administered in the United States so far were manufactured at the firm’s plant in the Netherlands, not by Emergent. For weeks the F.D.A. has been trying to figure out what to do about at least 170 million doses of vaccine that were left in limbo after the discovery of a major production mishap involving two vaccines manufactured at the Baltimore factory.

More than 100 million doses of Johnson & Johnson and at least 70 million doses of AstraZeneca were put on hold after Emergent discovered in March that its workers had contaminated a batch of Johnson & Johnson’s vaccine with a key ingredient used to produce AstraZeneca’s. Federal officials then ordered the plant to pause production, stripped Emergent of its responsibility to produce AstraZeneca’s vaccine and instructed Johnson & Johnson to assert direct control over the manufacturing of its vaccine there.

Johnson & Johnson’s vaccine was once considered a potential game-changer in the nation’s vaccine stock because it required only one shot and was particularly useful in vulnerable communities. But the federal government now has an ample supply of the vaccines from Pfizer-BioNTech and Moderna, the two other federally authorized vaccine developers, and no longer needs Johnson & Johnson’s supply.

Still, the loss of 60 million Johnson & Johnson doses puts a dent in the Biden administration’s plan to distribute vaccines to other countries that are still in the grip of the pandemic. The administration had been counting on sharing doses of both Johnson & Johnson and AstraZeneca but had to delay its plan while the F.D.A. completed a review of the facility.

After he arrived in Britain for the Group of 7 summit this week, President Biden announced he had found another source for donations. Pfizer-BioNTech has now agreed to sell his administration 500 million doses at cost for donation to low and lower-middle income countries over the next year. The World Health Organization estimates that 11 billion doses are needed globally to stamp out the epidemic.


Later , the NYT expanded this article with additional information.

https://www.nytimes.com/2021/06/11/us/politics/covid-vaccine-emergent-johnson-johnson.html

Thursday, June 10, 2021

Think Twice Before Giving the COVID Vax to Healthy Kids/ Med Page Today

 https://www.medpagetoday.com/opinion/marty-makary/93029

— Based on the data to date, there's no compelling case for it right now
A young girl wearing a protective mask receives the COVID-19 vaccine

The case to vaccinate kids is there, but it's not compelling right now. The Delta variant (B.1.617.2) could change the calculus depending on forthcoming data from the U.K., Singapore, and India where the variant may be demonstrating more contagious and virulent properties in younger people. By now we should all know that it is important to have humility in dealing with this virus. An increase in cases in the U.K. over the last few days is concerning and should be something we follow closely.

Returning to the discussion of the COVID-19 risk to kids (ages 0 to 12 years) right now, it's worth aggregating the best available data to date. In reviewing the medical literature and news reports, and in talking to pediatricians across the country, I am not aware of a single healthy child in the U.S. who has died of COVID-19 to date. To investigate further, my research team at Johns Hopkins partnered with FAIR health to study pediatric COVID-19 deaths using approximately half of the nation's health insurance data. We found that 100% of pediatric COVID-19 deaths were in children with a pre-existing condition, solidifying the case to vaccinate any child with a comorbidity.

Given that the risk of a healthy child dying is between zero and infinitesimally rare, it's understandable that many parents are appropriately asking, why vaccinate healthy kids at all?

To those parents, I would say the primary reason to give a healthy child the vaccine may not be to save their life, it's to prevent the multisystem inflammatory syndrome (MIS-C), which can be painful and have long-term health sequelae. According to the CDC, there have been 4,018 cases of MIS-C after COVID-19 with the average age being 9 years old. A total of 36 children died. Cases of MIS-C were heavily skewed toward minority children (62% were Hispanic/Latino or Black), likely due to the disproportionate rates of childhood obesity and chronic conditions in these populations. This finding again supports COVID-19 vaccination in any child with a medical condition, including being overweight.

It's also important to note that the COVID-19 exposure risk in children is not linear over time. Since new COVID-19 case rates began quickly declining in May, the weekly rate of new cases of MIS-C associated with COVID-19 has decreased to zero. And this week, a CDC report on child hospitalizations for COVID-19 in March and April, 2021 found zero deaths in the entire cohort of children studied.

There is an argument for vaccinating children to create a community benefit for kids. Vaccinating healthy kids can help reduce virus transmission to at-risk kids who choose not to get vaccinated or others who cannot get the vaccine. On the other hand, data from Israel suggest that when adult vaccination rates are high, transmission among kids is markedly reduced -- a trend now noted in the U.S. We also know that children are inefficient transmitters of COVID-19 compared to adults. That could potentially change with new information on the recent Delta variant, but so far it hasn't.

The extremely low chance of any benefit for healthy children is exactly why pediatricians like Richard Malley, MD, of Harvard, and Adam Finn, MD, PhD, of the University of Bristol, have passionately written to not "use precious coronavirus vaccines on healthy children." A recent editorial in The BMJ echoed this sentiment -- an argument also eloquently articulated by MedPage's own Vinay Prasad, MD, MPH. From a global perspective, two doses of a globally scarce, life-saving vaccine could be more equitably used to immunize a 65-year-old couple in India or Brazil (one dose for each person) rather than giving both doses to one 5-year-old healthy child. Accordingly, California's announcement to spend $116 million to pay people to get the vaccine when much of the world is begging for it in the midst of raging epidemics is a sad commentary on our country's excess, inequity, and ethnocentrism.

There may also be unique side effects in children from the second COVID-19 vaccine dose. Seven adolescent children were reported to have myocarditis within 4 days after receiving the second Pfizer vaccine dose. All were in boys ages 16 to 19. Both mRNA vaccines have been found to be 100% effective in preventing COVID-19 in kids. But anytime a medication is found to be 100% effective, it should call to question whether the dose is too high, the interval is too short, or if there is a need for the second dose at all. Pfizer is now looking at lower vaccine doses for children, as they mentioned Tuesday in their announcement that they are starting their vaccine trial in kids under age 12.

Importantly, and affirmed 2 weeks ago from a Washington University study, immunity is not just conferred by antibodies, it's also a function of memory B and T cells, which the study researchers suggested may confer long-lasting immunity. Given the near-zero risk of COVID-19 death in healthy children and the recent discovery of rare myocarditis complications immediately after the second dose, this should raise a discussion of whether a single dose is the more appropriate approach for healthy kids.

In my residency training, I was taught an old dictum many of you might be familiar with: "If you give someone blood, always give at least two units." It took decades for the medical community to undo that dogma. We now understand that there are rare but real harms to a second unit of blood. We have matured to recognize that if a second unit is not necessary, one unit is actually safer than two. We should similarly abandon the notion that the vaccine must always be given as two doses. In transplant patients for example, it may be three. In kids with natural immunity from prior infection, it may be none.

What about children who are confirmed to have had COVID-19 infection in the past? I would recommend avoiding COVID-19 vaccination. Looking at natural immunity in adults as a point of comparison, the observational and empirical data are overwhelming: natural immunity is real and it works.

Researchers from the Cleveland Clinic published a study this week that found "Not one of the 1,359 previously infected subjects who remained unvaccinated had a SARS-CoV-2 infection over the duration of the study." This is one of many studies showing that natural immunity is powerful. While the long-term durability of natural immunity is unknown, it's also unknown for vaccinated immunity. We can postulate with strong rationale, but to be true to the science, we have zero data beyond 18 months for either. In fact, there is more follow-up data on natural immunity than there is on vaccinated immunity. Based on accumulating data, children who have had COVID-19 should not get vaccinated, unless they are immunocompromised.

One final and minor consideration should be needle anxiety, which has no or minimal effect on most children but can be traumatic for some. For kids who should receive the vaccine and also have needle anxiety, cold therapy and vibrating devices, such as with the "Buzzy" device, can be applied to the skin injection site prior to injection and result in little to no pain.

In my opinion, the COVID-19 vaccine makes sense for any child who is overweight or has a pre-existing condition. It also may make sense for a teenager given their closer physiologic similarity to adults and the fact that historically, vaccines safe in adults have been safe in kids when dosed appropriately. But given the case-report level rarity of a healthy child dying of COVID-19, I would not recommend a two-dose vaccine regimen for a healthy child ages 0 to 12 years until we have more data. Each parent will have to assess their own child's individual risk, but in my opinion, the case to vaccinate young healthy kids is not compelling right now.

Marty Makary, MD, MPH, is Editor-in-Chief of MedPage Today and a professor at the Johns Hopkins School of Medicine, Bloomberg School of Public Health, and Carey Business School. He is author of The Price We Pay.