Tag Archives: fda

big pharma, Crimes Against Humanity, Independent Media, law, Notable Occurrence

‘Paramount Importance’: Judge Orders FDA to Release Pfizer Vaccine Docs this Year, Not Over Next 75 Years

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Score one for transparency.

A federal judge in Texas on Thursday ordered the Food and Drug Administration to make public the data it relied on to license Pfizer’s COVID-19 vaccine, imposing a dramatically accelerated schedule that should result in the release of all information within about eight months.

That’s roughly 75 years and four months faster than the FDA said it could take to complete a Freedom of Information Act request by a group of doctors and scientists seeking an estimated 450,000 pages of material about the vaccine.

The court “concludes that this FOIA request is of paramount public importance,” wrote U.S. District Judge Mark Pittman in Fort Worth, who was appointed to the bench by former President Donald Trump in 2019.

The FDA didn’t dispute it had an obligation to make the information public but argued that its short-staffed FOIA office only had the bandwidth to review and release 500 pages a month.

While Pittman recognized “the ‘unduly burdensome’ challenges that this FOIA request may present to the FDA,” in his four-page order, he resoundingly rejected the agency’s suggested schedule.

Rather than producing 500 pages a month — the FDA’s proposed timeline — he ordered the agency to turn over 55,000 a month. That means all the Pfizer vaccine data should be public by the end of the summer rather than, say, the year 2097.

Even if the FDA may not see it this way, I think Pittman did the agency — and the country — a big favor by expediting the document production.

I’ve been chronicling this fight since November and have heard from dozens of readers who said they felt something was suspicious, even nefarious, in the FDA’s proposed slo-mo timeline. Making the information public as soon as possible may help assuage the concerns of vaccine skeptics and convince them the product is safe.

Pittman in his order nodded to this as well, including a quote from the late senator John McCain, who said that excessive administrative secrecy “feeds conspiracy theories and reduces the public’s confidence in the government.”

Still, the FDA is likely to be hard-pressed to process 55,000 pages a month.

The office that reviews FOIA requests has just 10 employees, according to a declaration filed with the court by Suzann Burk, who heads the FDA’s Division of Disclosure and Oversight Management. Burk said it takes eight minutes a page for a worker “to perform a careful line-by-line, word-by-word review of all responsive records before producing them in response to a FOIA request.”

At that rate, the 10 employees would have to work non-stop 24 hours a day, seven days a week to produce the 55,000 pages a month (and would still fall a bit short).

But as lawyers for the plaintiffs Public Health and Medical Professionals for Transparency pointed out in court papers, the FDA as of 2020 had 18,062 employees. Surely some can be dispatched to pitch in at the FOIA office.

Aaron Siri of Siri & Glimstad, who represents the plaintiffs, in an email said the decision “came down on the side of transparency and accountability.”

His clients — a group that includes more than 200 doctors, scientists, professors and public health professionals, including some who have publicly questioned the efficacy of lockdown policies, mask mandates and the vaccine itself — have pledged to publish all the information they receive from the FDA on their website.

The Justice Department, which represented the FDA in the litigation, did not immediately respond to a request for comment on Thursday evening. Pfizer, not a party to the suit, also did not immediately respond to a request for comment.

Pittman in his order made clear that the FOIA request, even if burdensome, has to be a priority for the FDA.

Quoting from remarks made during the hearing before him on December 14, he wrote that “there may not be a ‘re important issue at the Food and Drug Administration . . . than the pandemic, the Pfizer vaccine, getting every American vaccinated,” and assuring the public that the vaccine was not “‘rush[ed] on behalf of the United States.'”

big pharma, corruption, politics

Bernie Sanders Votes “No” for Biden FDA Chief Pick, Who Holds Millions in Big Pharma Investments

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Brett Wilkins
December 22, 2021

Editors Note: This article expresses the opinions of the author, and does not necessarily reflect those of the Underground Newswire.

We do not need “leaders” in our bureaucracy who have any financial connections with the industries they’re supposed to help regulate. That’s a general rule, but when it comes to Big Pharma this mentality should be twice as potent. There’s a reason why so few on either side of the political aisle are willing to hold Big Pharma accountable. They own DC more than Big Oil, Big Education, or even Big Tech.

The FDA should be run by someone who has a healthy distrust of the pharmaceutical industry. That’s not to say we need someone who will stifle innovation by overregulating or otherwise hampering research, but with something as important to the well-being of Americans as the drug industry, there are many reasons to oppose someone who has had their hands in the cookie jar before or may have their hands in there again in the future.

With that said, here’s Brett’s take on Dr. Robert Califf…

Citing Multimillion-Dollar Big Pharma Ties, Sanders to Vote ‘No’ on Biden’s Pick for FDA Chief

Sen. Bernie Sanders last week said he would oppose President Joe Biden’s nomination of Dr. Robert Califf to lead the U.S. Food and Drug Administration (FDA) for the second time, citing the cardiologist’s multimillion-dollar ties to Big Pharma.

Califf — who served as FDA commissioner during the final 11 months of the Obama administration — mostly skated through a congenial Senate confirmation hearing Tuesday.

According to STAT, his only stumble occurred when he was pressed about the FDA’s role and failings in the opioid crisis.

The Associated Press reports Senate Health, Education, Labor and Pensions Committee Chair Patty Murray (D-Wash.) and the ranking Republican member, Sen. Richard Burr of North Carolina, both said they would vote to confirm Califf.

Sanders (I-Vt.), however, reprised his 2015 confirmation grilling of Califf over his lucrative ties to Big Pharma.

“One of the major reasons the pharmaceutical industry, among many others, is so powerful is its close relationship with the FDA and other regulators in Washington,” the democratic socialist, who twice ran for president on a Medicare for All platform, said during the hearing.

“What kind of comfort can you give to the American people when you have been so closely tied to the pharmaceutical industry yourself?”

Califf — who has made millions of dollars as a consultant for more than a dozen pharmaceutical corporations and who holds millions more in Big Pharma investments — replied that he was “totally with” Sanders, agreeing that “the price of pharmaceuticals is way too high in this country.”

Sanders said he would once again vote to reject Califf’s nomination.

“At a time when the American people pay the highest prices in the world for prescription drugs and as drug companies continue to be the most powerful special interest in Washington, we need leadership at the FDA that is finally willing to stand up to the greed and power of the pharmaceutical industry,” Sanders said in a statement.

“Not only have the drug companies spent over $4.5 billion on lobbying and hundreds of millions of dollars in campaign contributions over the past 20 years, they also have created a revolving door between the FDA and the industry,” he continued. “Shockingly, nine out of the last 10 FDA commissioners went on to work for the pharmaceutical industry or to serve on a prescription drug company’s board of directors.”

“Unfortunately, Dr. Califf is not the exception to that rule,” Sanders said. “After leaving the FDA in 2017, he received consulting fees from Merck, Biogen, and Eli Lilly. According to his financial disclosure form, he owns up to $8 million in the stocks of major drug companies.”

“That is exactly the close relationship Big Pharma has exploited to regulate the FDA, instead of the FDA regulating them,” he added. “The Covid-19 pandemic has made clearer than ever the choice between pharmaceutical profits and the health of our people. In this critical moment, Dr. Califf is not the leader Americans need at the FDA and I will oppose his nomination.”

Sixty-nine current senators voted for Califf’s previous nomination.

In addition to Sanders, at least two other members of the Democratic caucus oppose his appointment: Sens. Richard Blumenthal (D-Ct.), who cites his industry ties, and Joe Manchin (D-W.Va.), who last month said that the nomination “makes no sense as the opioid epidemic continues to wreak havoc on families across this country with no end in sight.”

big pharma, law, Notable Occurrence, Uncategorized

FDA Wants Until 2076 To Fully Release Pfizer Vaccine Data: Lawsuit

The Free Thought Project, 
November 18, 2021

The FDA has asked a federal judge to make the public wait until the year 2076 to disclose all of the data and information it relied upon to license Pfizer’s COVID-19 vaccine. That is not a typo. It wants 55 years to produce this information to the public.

As explained in a prior article, the FDA repeatedly promised “full transparency” with regard to Covid-19 vaccines, including reaffirming “the FDA’s commitment to transparency” when licensing Pfizer’s COVID-19 vaccine.

With that promise in mind, in August and immediately following approval of the vaccine, more than 30 academics, professors, and scientists from this country’s most prestigious universities requested the data and information submitted to the FDA by Pfizer to license its COVID-19 vaccine.

The FDA’s response?  It produced nothing. So, in September, my firm filed a lawsuit against the FDA on behalf of this group to demand this information. To date, almost three months after it licensed Pfizer’s vaccine, the FDA still has not released a single page. Not one.

Instead, two days ago, the FDA asked a federal judge to give it until 2076 to fully produce this information. The FDA asked the judge to let it produce the 329,000+ pages of documents Pfizer provided to the FDA to license its vaccine at the rate of 500 pages per month, which means its production would not be completed earlier than 2076.  The FDA’s promise of transparency is, to put it mildly, a pile of illusions [ZH, we note that the FDA justifies this by claiming that the rate of 500 pages per month “is consistent with processing schedules entered by courts across the country in FOIA cases,” and blames the plaintiffs for “its own broad FOIA request”].

It took the FDA precisely 108 days from when Pfizer started producing the records for licensure (on May 7, 2021) to when the FDA licensed the Pfizer vaccine (on August 23, 2021).   Taking the FDA at its word, 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. While it can conduct that intense review of Pfizer’s documents in 108 days, it now asks for over 20,000 days to make these documents available to the public. 

So, let’s get this straight. The federal government shields Pfizer from liability.  Gives it billions of dollars.  Makes Americans take its product.  But won’t let you see the data supporting its product’s safety and efficacy.  Who does the government work for?

The lesson yet again is that civil and individual rights should never be contingent upon a medical procedure.  Everyone who wants to get vaccinated and boosted should be free to do so.  But nobody should be coerced by the government to partake in any medical procedure.  Certainly not one where the government wants to hide the full information relied upon for its licensure until the year 2076!

big pharma, Health, Independent Media, Independent Research, Investigative Journalism

The FDA’s Cushy Relationship With The Pharmaceutical Industry

Ryan DeLarme,
September 12th, 2021

People are rushing to tout the recent FDA approval of Pfizer’s mRNA vaccine as if it were some great scientific victory. The troubling part is that the institution’s shady history seems to be all but forgotten.

No matter how you slice it, the Pharmaceutical industry is the central engine of the global health establishment. The industry’s larger corporations (Pfizer, Moderna, Johnson & Johnson, Merck, etc.) provide funding for the FDA, the CDC, the WHO; they do this both directly and through NGOs like the EPDA. It was recently reported that pharmaceutical giants are raking in the money with the sale of their novel and inadequately tested COVID-19 vaccines. Pfizer expects to earn $33.5 billion in 2021. J&J estimates its full-year COVID-19 vaccine sales to be $2.5 billion while Moderna forecasts $19.2 billion. These enormous figures will be grossly surpassed when one considers the forthcoming round of booster shots and the profits those will yield. 

When it comes to lobbying money spent in 2021, the Pharmaceutical Research & Manufacturers of America group ranks number three nationally. Interestingly, the fourth, fifth, and sixth positions are also members of the health establishment. These are the American Hospital Association, Blue Cross/Blue Shield, and the American Medical Association, respectively. Pfizer by itself is number 15.

The ties between the FDA and Big Pharma run deep, their relationship has become so symbiotic that neither could exist without the other unless massive reforms were to take place. Big Pharma relies on the FDA to approve and rush their products to market and the FDA relies on Big Pharma to receive its funding. Not only that but there seems to be a revolving door of FDA Commissioners landing on the boards of these Pharmaceutical companies. 

Scott Gottlieb, who stepped down as FDA Commissioner in the spring of 2019, soon found himself sitting comfortably on Pfizer’s board of directors.  Gottlieb’s predecessor, DR. Margaret Hamburg, landed a cushy position on the board of Directors for Alnylam Pharmaceuticals, Inc. Steven Hahn, the former FDA Commissioner under Donald Trump, wound up at Flagship Pioneering; the venture capital firm that launched Moderna. 

The list goes on and on, in fact, 9 out of the last 10 FDA commissioners —representing nearly four decades of agency leadership— have gone on to work for pharmaceutical companies. The lone exception was David Kessler, who joined the ranks in academia before eventually settling in his current position as chair of the board of directors at the Center for Science in the Public Interest.

Criticism towards the modern medical-industrial complex has triggered many arguments, this is particularly true in the age of COVID. Regardless of whatever stance you take on any medical debate, it is undeniable that the industry operates in the same mafia-esque fashion as the Media, Big Tech, and Big Government.

Health, Notable Occurrence, Uncategorized

FDA Issues Warnings about 9 Hand Sanitizers That Can Be Toxic and Potentially Deadly If Absorbed by the Body

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BN Frank
June 28th, 2020

The Food and Drug Administration (FDA) is responsible for protecting Americans from harmful products. Their track record leaves a lot to be desired. They’ve been blamed by experts and whistleblowers for greatly contributing to the Opioid Crisis.

Because of the pandemic, Americans are using more hand sanitizer than ever before on themselves and their loved ones. Sometimes this is a requirement – not a choice. Here’s a “better late than never” warning about which ones could make you really sick AS WELL AS ultimately cause death.

From MarketWatch:

Here are 9 hand sanitizers that the FDA warns can be toxic if absorbed by the body

By Mark DeCambre

The FDA issued a warning about sanitizers manufactured by Eskbiochem SA de CV in Mexico

The Food and Drug Administration over the weekend issued a warning on nine alcohol-based hand sanitizers manufactured by Eskbiochem SA de CV in Mexico that it says contain wood methanol, a toxic substance that could ultimately result in death of absorbed through the skin or ingested.

“Consumers who have been exposed to hand sanitizer containing methanol should seek immediate treatment, which is critical for potential reversal of toxic effects of methanol poisoning,” the FDA wrote on June 19.

“Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death,” the report indicated. The agency said the risk of possible ingestion centered mostly on young children or adolescents who might use alcohol-based sanitizers as a substitute for grain alcohol.

Here are a list of the hand sanitizers manufactured by Eskbiochem:

All-Clean Hand Sanitizer (NDC: 74589-002-01)

Esk Biochem Hand Sanitizer (NDC: 74589-007-01)

CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-008-04)

The Good Gel Antibacterial Gel Hand Sanitizer (NDC: 74589-010-10)

CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-005-03)

CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-009-01)

CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-003-01)

Saniderm Advanced Hand Sanitizer (NDC: 74589-001-01)

The FDA warnings comes as the coronavirus crisis has ramped up demand for hand sanitizer across the globe. At the height of the pandemic in March, a number of retailers, including Costco Wholesale Corp. COST, -1.32%, BJ’s Wholesale Club Holdings Inc. BJ, -0.97% and Kroger Co. KR, -0.30%, reported surging sales in hand-cleaning products and other sanitizing merchandise. In the week ending April 25, Nielsen said hand sanitizer saw the highest in-store week-over-week growth.

Individuals have even taken to attempting to make their own hand sanitizer; however, the U.S. Centers for Disease Control and Prevention has said that washing hands with plain soap and water is the best way to kill the novel strain of coronavirus that causes COVID-19.

Moreover, hand sanitizer requires at least 60% alcohol. Alcohol dissolves the lipid membrane and disrupts other supramolecular interactions in viruses but you need a fairly high concentration of the alcohol to get a rapid dissolution of the virus. Vodka or whiskey — usually 40% ethanol — won’t dissolve the virus as quickly. “Overall, alcohol is not as good as soap at this task,” wrote Palli Thordarson, a professor at the School of Chemistry at the University of South Wales, Sydney in a column for MarketWatch in April.

A message requesting comment from Eskbiochem wasn’t immediately returned.