Another Critical Thinker Reaches The Obvious Conclusion: Intermittent Renewables Can’t Work On Their Own
By Francis Menton | Manhattan Contrarian | December 3, 2023
Let me welcome to the small and elite club of critical thinkers on the supposed energy transition a guy named Balázs Fekete. Fekete, with several co-authors, has recently (September 18) succeeded in getting an article published in a journal called Frontiers of Environmental Science, with the title “Storage requirements to mitigate intermittent renewable energy sources: analysis for the US Northeast.” Fekete then followed up by publishing on November 14 at Judith Curry’s Climate, Etc. blog a lengthy post summarizing the article, titled “Net-Zero Targets: Sustainable Future or CO2 Obsession Driven Dead-end?”
As with the previous competent analyses of energy storage requirements needed to back up intermittent renewable generation that have been featured on this blog and in my energy storage Report, there is nothing complicated about the Fekete, et al., analysis. The authors call it “a modified surplus/deficit calculation [as] taught to water engineers to size reservoirs for meeting water demand when the water resources vary.” When there is surplus production you add it to storage, and when there is a deficit you subtract; and then you sum over a year (or two, or ten) to calculate how much storage you need. It’s all basic arithmetic. What could be simpler?
You will not be surprised that the conclusion is “CO2 obsession driven dead-end.”
This subject would seem almost too obvious and trivial to cover on this blog. There is nothing complicated here. Everybody who is involved in any way in the energy transition game, and who has even the lowest level of professional competence, simply must be aware of this subject and of these calculations. And yet I just attended the big New York “Climate Summit,” (aka the Krazy Klimate Konference), featuring all of the powerful politicians and bureaucrats and industry leaders who are in charge of our state’s energy transition, and to a person they have no idea about any of this. And by no idea, I mean none, zero, zilch. One guy even came up to me and accused me of being “rude” for laughing out loud at his astounding ignorance. (The only other possibility was that it was intentional comedy.)
Unsurprisingly, the authors of Fekete, et al., make no claim to being “climate scientists.” Climate scientists as a class are way too smart to stoop to doing basic arithmetic. In the intro to the paper, Fekete identifies himself as a professor at the City University of New York — of Civil Engineering. Second author Mihály Bacskó is a former executive of the Hungarian Power Company. The other two co-authors are meteorologists working at the University of Oklahoma. In other words, the focus here is not on scaring the public with frightening scenarios from the occult voodoo of climate “science,” but rather only on whether the proposed solutions will or will not work.
The particular calculations in Fekete, et al., look at data from twelve states of the northeastern U.S. — New England, plus New York, New Jersey, Pennsylvania, Delaware, Maryland and West Virginia. Rather than using production data from existing wind and solar facilities, the authors obtained daily wind speed and solar irradiation data for the region. For consumption data, the blog post states that the authors applied an assumption of “constant energy consumption,” after determining that “seasonal variations of energy consumption are relatively small (deviate by only 10-15% of the annual average).” (Perhaps this decision could be criticized, but I doubt that it makes any material difference to the conclusion.)
And the bottom line is:
The storage capacity needed to align power generation from solar or wind is around 25% of the annual energy consumption.
In other words, you need three months worth of storage to try to make this work. Previous studies that I highlighted in my energy storage Report — for example, those of Roger Andrews and Ken Gregory — had calculated storage needs in the range of one to two months. However, those studies only used one year’s worth of data for each calculation, and allowed running the storage balance right down to zero. If you think that it’s too risky to run the storage right down to zero before the balance starts to refill, then three months of storage is a much more reasonable figure. Indeed, it’s still rather conservative.
Fekete, et al., don’t get into the specifics of cost of any possible storage solution. But then, they don’t need to. The potential costs are so enormous as to completely rule out any attempt even to start down this road. According to the U.S. Energy Information Administration, total U.S. electricity consumption in 2022 was just over 4 trillion kWh. So one-quarter of that would be just over 1 trillion kWh. Just to get an idea of the cost of that much energy storage, this site (Tesla fans) gives a (highly optimistic) cost for Tesla batteries of just over $100 per kWh. So a trillion of those will run you about $100 trillion. That’s four times the entire U.S. economy. Meanwhile, a Tesla-style battery is not remotely up to the job of the energy storage needed to back up wind/solar electricity generation, which would necessarily include the ability to save up power over a year or more and discharge over a year. But then, the economics are so wildly out of line that it’s hardly worth worrying about such technicalities.
Fekete, et al., in a very understated manner, put it this way:
In the absence of energy storage technology that can store several months worth of energy, one has to conclude that all studies suggesting that solar or wind are price competitive with other forms of energy should be retracted.
The Fekete blog post at Climate, Etc. contains two other subjects of interest. One relates to the peer review process. It appears that one of the peer reviewers made a run at getting the paper blocked, without stating the nature of any substantive criticisms:
One of the reviewers stated that “The manuscript contains fundamental errors that cannot be rectified through author revisions” without venturing into any details.
Fekete calls this effort “unscientific, unjust, and unethical,” which is again quite an understatement. Sadly, such conduct is the norm in what goes by the name “climate science” today. Fortunately, in this case, another reviewer was supportive, as was the staff of the journal.
The second subject of further interest in the blog post is that another reviewer criticized the draft paper for alleged “lack of references to the “plethora of work” related to integrating renewables to the current energy systems and transitioning to a sustainable energy future.” The criticism caused the authors to “roll up their sleeves” and go out and review some 360 papers recommended by the critic. Here is a list of what they found:
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The inter-annual and seasonal variations were rarely studied.
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The vast majority of the studies were limited to diurnal and minute-by-minute variations.
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The publications only investigated the use of few hourly storage capacities.
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The primary sustainability metric was reducing CO2 emissions.
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Most of the publications were limited to low renewable penetration.
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No publication attempted to address complete decarbonization.
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Even the most ambitious “deep decarbonization” scenarios stopped at 25-50% renewable contributions that was considered “high renewable penetration”.
And in summary:
Most of the reviewed papers assumed that solar and wind will be always supplemented by some form of “firm generation capacity”, which is the obfuscated name of using fossil fuels complemented with “carbon capture and sequestration”.
In other words, the orthodox “peer reviewed” scientific literature is almost completely lacking in consideration of the most important, fundamental problem of transitioning to an energy system based on electricity generated by the wind and sun. Well, now there is one competent paper in the mix. They will do their best to ignore it, at least until the whole wind/solar thing has conclusively shown that it can’t work.
Main National TV Station Pumps INSANE Propaganda
Ivor Cummins | November 20, 2023
Our National main TV station just aired an INSANE piece of WEF/UN-style propaganda – it’s a parody of itself! Nonetheless I have a great time taking it down hardcore ;-) Please share widely – you can download vid here too, to share elsewhere:
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Curious Admission Surfaces Concerning MHRA Blackmailing Mainstream Media Outlet Over Adverse Event Reporting
And no one really picked up on it…
BY JJ STARKY | NOVEMBER 25, 2023
Mass consumers of news – me included – are often exposed to so much information that some of that information can be lost in all the noise.
There’s little explanation why such a bombshell revelation featured in a recent Telegraph article gained next to no attention.
On 8th November, journalist Sarah Knapton published an article, entitled, ‘In the end, the AstraZeneca vaccine just wasn’t as good as its rivals’. Knapton broke down how AstraZeneca’s (AZ) purported efficacy could not stand up to the purported efficacy of the other vaccines. The consequences of which led to its eventual abandonment.
Curiously, however, buried in the 14th paragraph, was a confession that back in March 2021 – when the Telegraph first reported on AZ’s blood clot risks – Medicines and Healthcare products Regulatory Agency (MHRA) officials effectively blackmailed them.
Knapton writes:
“On the day we published the story we received a threatening phone call from a senior official at the MHRA warning that The Telegraph would be banned from future briefings and press notices if we did not soften the news.
Another well-known Cambridge academic got in touch to complain about our “disgraceful fear-mongering headline” on the story, claiming that it would discourage vaccine uptake and cost lives.”
This was the headline of that 17th March 2021 article:

Considering the title includes a subjective opinion from a foreign medical regulator that softens the news, I’m not sure how it constitutes “disgraceful fear-mongering”.
Perhaps this remark is more reflective of the contagious petulance we witness with medical regulators. For them, negative news is not just negative news. It’s analogous to physical assault.
What seems far more “disgraceful” is how a supposedly impartial medical regulator – tasked with safeguarding citizens from potentially lethal treatments – allegedly threatened to strip away a news organisation’s access. Leaving them out in the cold as competitors would stand to benefit from their potential exclusion.
And the curious thing is, no one has seemed to pick up on the news bar The Conservative Woman and the Health Advisory & Recovery Team (HART).
A report from HART earlier in August further revealed that MHRA officials have been blocking journalists, scientists, and vaccine injured victims on social media. HART asked them why and they responded:
“Thank you for flagging your issue about Twitter. We’ve reviewed recent action taken on that platform and have identified accounts which have been blocked in error, these have now been unblocked and you should be free to interact with our content again. Please let us know if you have any further issues so we can investigate and rectify, if necessary”.

“Sorry folks, it was error. And a complete ‘coincidence’ that we primarily blocked commentators who were critical of us…”
These are the same officials who refused to answer a routine Freedom of Information Request concerning data AstraZeneca submitted in their application to licence their Covid-19 vaccine. The reason they refused? It was “vexatious”.
They wrote in their response:
“this request falls to be considered “vexatious” due to the scope of the request and the disproportionate burden that compliance would create. S14(1) of the FOIA states that “Section 1(1) does not oblige a public authority to comply with a request for information if the request is vexatious.
Downloading the dossier of the vaccine is a relatively straightforward task, although it does require time. Due to the voluminous size of the file packages, when downloading the full package of data, the database software may be more prone to freeze. However, the time required to read through the dossiers, to identify exempt information and to consider and make redactions we expect would take many weeks, if not months to complete, as the dossier encompasses gigabytes of data. To meet the request our staff: Would need to read the dossier in full, in order to identify where redactions need to be made.
We appreciate that there remains a strong public interest in COVID-19 vaccines, however, we do not feel that the public interest outweighs the resource burden required to meet your request.”
Sometimes the actions of government officials are laced with so much arrogance, incompetence, and just frank laziness that it makes one question if they’re genuinely true.
If I sat across the table from an uninitiated countryman and told him of the above, it would come as no surprise to see him raise his eyebrows in astonishment. But not because of what I was telling him, but at me, as if I was about to descend into prophetic trance about how judgement day is coming and there’s going to be some epic battle between us and the lizard people outside Matt Hancock’s house.
Put differently, the extent to which the medical regulators’ actions are so unbelievable actually benefits them. It is easier for people to dismiss it as false. Of course, if the media actually did their job, this wouldn’t be a problem.
Naturally, when MHRA threatened the Telegraph, the outlet hesitated to revisit the subject for months. The blackmail paid off.
Were covid vaccine trials misleading by design?
Data presentation was deceptive
Health Advisory & Recovery Team | November 23, 2023
In chemotherapy, the primary aim is to reduce the disease burden in patients who are already diagnosed with cancer. This is reflected in endpoints like tumour size reduction, progression-free survival, and overall survival, which are directly related to the degree of disease burden. Therefore, measuring the benefit of chemotherapy involves comparing the extent of disease burden (or its progression) at the end of the trial between those who received the chemotherapy and those who did not. This comparison provides insight into how effectively the chemotherapy mitigates the impact of the cancer.
On the other hand, vaccines are designed with the primary goal of keeping individuals healthy by preventing the onset of a specific disease. Therefore, the efficacy of vaccines is best measured by comparing the health status among participants at the end of the trial. This involves assessing how many individuals remained healthy and disease-free in the vaccinated group versus the control group. Such an approach accurately reflects the preventive nature of vaccines.
The covid vaccine trials did not focus on how many were healthy instead comparing those who developed disease. To take the Pfizer/BioNTech trial as an example, there were 8 PCR positive symptomatic people in the vaccine group and 162 in the placebo group more than a week after the second dose and after up to 2 month’s follow up. That worked out at a 94.6% efficacy when calculated as a percentage reduction.
That sounds fantastic but it is not fantastic when measured in other ways. There is more than one scenario that could result in a claim of a 94.6% relative risk reduction as shown in the table. The alternative ways of measuring show the relative change in the percentage who remained healthy and the absolute change – i.e. the percentage of the population who benefitted.

In a hypothetical trial in which 94% of the placebo group developed a disease while only 5% of the treatment group did would also have a 95% efficacy as calculated the conventional way. However, these results have a totally different meaning to a patient. In this scenario 93.7% of the individuals who received the treatment directly benefited. Furthermore there was a marked change, 91.0% in the proportion who remained healthy.
Adjusting the percentages affected shows numerous situations in which the Relative Risk Reduction as conventionally calculated are identical but the Relative Risk Reduction in the proportion remaining healthy and the proportion who directly benefited tell a very different story. The last row are the actual results.

For the first two scenarios the people taking the treatment are more likely to directly benefit than not. For scenarios 3 and 4 there is still a high possibility of direct benefit. However, for the last two scenarios the chances of not directly benefiting are far higher than the chance of benefitting. It is possible in these scenarios that a longer follow up would improve the situation as more people would develop disease or be protected from it. However, the evidence of waning means that the time frame of follow up is close to the maximum possible period of benefit anyway.The important lesson here is that looking at the relative risk reduction as presented in the trials on its own is a meaningless measure. That is why the industry’s own code of practice says, “Referring only to relative risk, especially with regard to risk reduction, can make a medicine appear more effective than it actually is. In order to assess the clinical impact of an outcome, the reader also needs to know the absolute risk involved. In that regard, relative risk should never be referred to without also referring to the absolute risk.” The efficacy claims, even if we trust the results, were presented to the public in a way that could be deliberately misinterpreted.
Pfizer, Moderna Spend Millions on Ads Featuring Catchy Phrases and Celebrities to Push COVID Shots
By Mike Capuzzo | The Defender | November 22, 2023
Facing dramatic stock market declines and growing resistance to their mRNA COVID-19 vaccines, Pfizer and Moderna are running upbeat TV commercials with jingles and celebrities to push COVID-19 vaccination just in time for the holidays.
The 30-second Pfizer commercial features a cheery, driving tune and smiling celebrities Martha Stewart, singer-songwriter John Legend, professional soccer player and progressive activist Megan Rapinoe, singer-songwriter Charlie Puth and football star Travis Kelce.
All but Rapinoe flash Pfizer’s trademark blue band-aids on a shoulder showing they got Pfizer’s COVID-19 shot.
“Got it,” Stewart says, as the Pfizer ad copy reads, “This season’s updated COVID-19 shots are here,” and “Ask your healthcare provider if getting your COVID shot with your flu shot is right for you.”
“Got yours?” is the Pfizer tagline.
Moderna’s 60-second TV spot wants its audience to “Spikevax that body.”
Spikevax is the brand name of the company’s COVID-19 vaccine. It refers to the artificial spike protein the vaccine is designed to stimulate in the body to allegedly trigger protective antibodies to the virus.
The commercial opens with an older man playing table tennis accompanied by a narrator, who says, “When it comes to your health … you ping and pong that body.”
The spot proceeds through a variety of ordinary people practicing their passions, including a woman blending a vegetable shake (“you green that body”), a man plunging into an ice bucket (“you plunge that body”), and a man and woman playing chess (“you brainpower that body).”
It concludes with, “You flu shot that body, and now, you Spikevax that body. Because even though the pandemic is over, COVID-19 isn’t.”
The pharmaceutical trade press portrayed the ads as an attempt by Pfizer and Moderna, whose COVID-19 vaccines were injected into more than 5 billion people worldwide during the pandemic, to reverse dramatic losses in their stock prices in recent weeks.
“With hardly any Americans signing up to receive the updated COVID-19 shot, Pfizer is pulling out all the stops to increase uptake,” said Dr. Joseph Mercola.
Mercola reported that Pfizer paid Kansas City Chiefs tight end Kelce an outsized $20 million to promote the drugmaker’s COVID-19 shots, compared to his $5 million-per-year total endorsements from McDonald’s, Papa John’s, Walgreens, Nike and Tide, and was trying to capitalize on the football star’s recent surge in popularity as he dates pop star Taylor Swift.
Other medical trade journals debated whether celebrity endorsements like Kelce’s will actually help or hurt Pfizer’s sales and stock price.
Critic: COVID shot ads don’t meet FDA requirements for biologic side effects
But doctors and scientists interviewed by The Defender were appalled that Pfizer and Moderna, and the governments and media that support them, would continue to push the mRNA COVID-19 vaccines blamed for more than 36,000 deaths reported to the U.S. government-run Vaccine Adverse Event Reporting System, or VAERS.
A large Canadian study of 17 countries estimated the COVID-19 vaccines killed approximately 17 million people around the world.
Dr. Peter Breggin, a New York psychiatrist and author with his wife Ginger of “COVID-19 and the Global Predators: We Are the Prey,” said the Pfizer and Moderna commercials draw the audience into “a never-never land of fakers.”
“This is a combination of extreme fraud and sham,” Breggin told The Defender. “We now know from multiple scientific studies that there was a broad panoply of adverse effects to the vaccines as there are with some very potent drugs. That resulted in death in some people, and with more reports to the CDC [Centers for Disease Control and Prevention] of deaths than all the other vaccines in the world combined.”
Breggin, a frequent expert witness in pharmaceutical cases involving dangerous drugs and co-author of the bestseller “Talking Back to Prozac: What Doctors Aren’t Telling You About Today’s Most Controversial Drug,” said the Moderna ad makes a passing reference to possible myocarditis side effects while the Pfizer spot names no possible dangers at all.
“They’re not like ordinary drug commercials,” he said, adding that neither meets the U.S. Food and Drug Administration (FDA) requirement for describing biologic side effects.
Pfizer outspent competitors on digital, TV ads for COVID shots
Big Pharma advertising is big business in the U.S., the only country in the world with the exception of New Zealand that allows direct pharmaceutical advertising to consumers.
Spending on the marketing of prescription drugs, health services, laboratory tests and disease awareness grew from $17.7 billion in 1997 to $29.9 billion in 2016, with the largest increases coming in direct-to-consumer spending, which nearly tripled to 32% of all medical marketing spending.
Between Jan. 1 and May 6, 2021, Pfizer spent $21.5 million on digital advertising alone to push its COVID-19 vaccine, while Johnson & Johnson spent $29.1 million marketing its COVID-19 vaccine.
Big Pharma TV ad spending grew 8% in 2022, reaching a total of $4.05 billion. Much of that was “COVID vaccine-related television commercials” with “companies such as Pfizer and BioNTech” spending “large amounts of TV dollars on campaigns highlighting ‘getting back to normal,’ featuring loved ones reuniting after years apart,” according to Fierce Pharma.
Pfizer was the biggest drug-ad spender at this year’s Oscars, shelling out an estimated $5.7 million for the most expensive spot in the televised event on its new COVID-19 drug ad: “If it’s COVID, it’s Paxlovid.”
Pfizer also aired the second-most-expensive TV ad at the Oscars, spending an estimated $3.8 million on another COVID-19 ad using “star power to emphasize risk factors and COVID-19 in [its] latest vaccine ad push” featuring celebrities including Pink, Questlove, Michael Phelps and Jean Smart.
The fourth-biggest advertising spender at the Oscars was the U.S. Department of Health and Human Services, which spent an estimated $1.9 million on a 30-second “awareness ad” with no pharma company mentioned “to get people to consider getting the latest COVID boosters amid ‘fading protection.’”
Despite nearly around-the-clock media reports and advertising by Big Pharma and governments urging people to get the latest COVID-19 vaccine and boosters, Pfizer’s September 2023 rollout of its updated 2023-24 COVID-19 shot suffered “abysmal” uptake, with only 7.1% of adults and 2.1% of children receiving the updated COVID-19 shot as of Oct. 14, according to Mercola.
Dr. Pierre Kory was encouraged that vast numbers of Americans, a majority of whom took the experimental mRNA COVID-19 shots during the pandemic, are waking up to the fact the mRNA technology is dangerous and its risk-reward benefit presents potentially frightening risk with little or no benefit, especially for children.
“It appears to me that pharma companies are now desperately marketing the vaccines to consumers via TV ads,” he said. “It looks like their previously winning strategy of fear-mongering via public health agency proclamations and widespread news media behavioral psychology ‘nudging’ tactics is now failing.”
Mike Capuzzo is the managing editor of The Defender. He is a former prize-winning reporter for The Philadelphia Inquirer and The Miami Herald, a science writer, and a regional magazine founding editor and publisher who has won more than 200 journalism awards as a writer, editor and publisher.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Texas Sues Pfizer for ‘Endangering Children’ by Selling Ineffective ADHD Drug
By Suzanne Burdick, Ph.D. | The Defender | November 22, 2023
Acting on behalf of the state of Texas, Attorney General Ken Paxton on Monday unsealed a lawsuit against Pfizer and its drug manufacturer, Tris Pharma, alleging the companies sold medication to children even though they knew the drug was ineffective and potentially unsafe.
The suit, filed in the Harrison County District Court, alleges Pfizer knowingly distributed a drug used for treating attention-deficit/hyperactivity disorder (ADHD) to children on Medicaid — despite the drug’s pattern of failing quality control tests.
The drug, Quillivant XR, is a stimulant that affects brain and nerve chemicals involved in hyperactivity and impulse control.
From 2012-2018, “Pfizer and Tris continually manipulated Quillivant testing to hide poor manufacturing practices and defraud the Texas Medicaid program,” according to a press release.
During those years, many families complained that the medication failed to work. According to the complaint:
“At no point did Defendants warn Texas Medicaid providers or decision-makers that Quillivant had known manufacturing issues affecting its efficacy, thereby depriving the Medicaid program of the crucial information it relies on. … As a result, thousands of Texas children received an adulterated Schedule II Controlled Dangerous Substance.”
In a tweet, Paxton said:
Commenting on the lawsuit, Kim Mack Rosenberg, acting general counsel for Children’s Health Defense, said, “Pfizer once again is in the spotlight for alleged unethical and fraudulent activity.”
Rosenberg told The Defender :
“I applaud the Texas AG for taking action here to protect some of Texas’s most vulnerable children, those who rely on Medicaid for healthcare. To knowingly supply adulterated medication to vulnerable children is inexplicable and unconscionable.”
“Unfortunately,” Rosenberg added, “this is not the first time questions have been raised about Pfizer’s conduct, including wrongdoing allegedly resulting in children dying in clinical trials in Nigeria in the 1990s and serious questions about Pfizer’s COVID-19 injections and its treatment medication Paxlovid.”
Defendants in the suit include Pfizer, Tris and Tris CEO Ketan Mehta.
The lawsuit stemmed from a whistleblower complaint made by Tarik Ahmed, who served as Tris’ technology chief from 2013-2017.
The lawyers are suing for more than $1 million, including civil penalty fees, and are asking the court to force Pfizer and Tris to pay back to the state of Texas all profits received from selling Quillivant in the Texas Medicaid program “as a result of Defendants’ unlawful acts” and, additionally, to pay back double that amount.
Lawyers with Paxton’s office requested a trial by jury.
In 2017, Quillivant grossed roughly $193.3 million in U.S. sales. The drug was developed by NextWave Pharmaceuticals, which Pfizer bought in 2012 for $680 million.
The lawyers charged the defendants with defrauding the Texas Medicaid program “by providing adulterated pharmaceutical drugs to Texas children in violation of the Texas Medicaid Fraud Prevention Act, now known as the Texas Health Care Program Fraud Prevention Act (‘THFPA’).”
The press release said, “For years, Tris altered the drug’s testing method in violation of federal and state laws to ensure Quillivant passed regulatory hurdles and could continue to be sold.”
According to Reuters, Pfizer said in a statement that it had examined the suit’s allegations on “multiple occasions” and “did not find any impact on the safety of the product.”
Pfizer said the case has no merit and will move to dismiss it.
A Tris spokesperson told Reuters in an email, “We categorically deny and intend to rigorously defend these allegations in the court of law.”
Drug failed quality control tests for years
Almost immediately after getting U.S. Food and Drug Administration (FDA) approval, Quillivant began failing routine quality tests. According to the complaint:
“Beginning at least as early as October 2012, Tris quality control personnel observed that sample of Quillivant tested under FDA-required dissolution specifications were not generating passing results.
“Dissolution testing is an important quality control tool used to measure whether a drug was properly manufactured, by comparing a simulated release of the drug to a standard set upon the drug’s initial approval.
“This in turn helps to predict whether the drug (as manufactured) will be released as expected in a patient’s body — which is critical for ensuring proper and consistent patient dosing.”
The Quillivant samples formed lumps during the reconstitution phase of the test.
Instead of investigating why there were lumps, Tris “retrained” its analysts to shake the water/drug mixture longer and to conduct the test only when “foaming is absent from the suspension,” the filing said.
Even with these changes, Quillivant continued to fail dissolution tests. Tris then stopped using that testing method and switched to a new method.
“Alarmingly,” the filing said, “the new test method was not representative of real-world usage by patients, and worse, went against the pharmacy reconstitution instructions contained in the FDA-approved label for Quillivant.”
When quality control issues continued to arise, the companies told the FDA a “misleading” and “convenient narrative to explain away the problem.”
Pfizer wanted to ‘fully exploit the economic potential of Texas Medicaid’
Meanwhile, Pfizer was petitioning Texas Medicaid to get Quillivant added to the program’s preferred drug list — but said nothing about the drug’s ongoing and unresolved quality control issues.
The FDA on March 26, 2018, sent a warning letter to Pfizer, informing the company that Quillivant was “adulterated starting in 2012 and continuing into 2018.”
Yet “even after receiving this clear and unequivocal assessment, neither Tris nor Pfizer alerted Texas Medicaid decision-makers to the FDA’s serious findings,” the filing said.
The suit alleges that the companies avoided telling Texas Medicaid about the issues because “Quillivant’s status with Texas Medicaid became a selling point.” The filing said:
“Tris and Pfizer both recognized that Texas Medicaid business would be crucial for Quillivant’s success.
“To fully exploit the economic potential of Texas Medicaid, Defendants needed Medicaid decision-makers to add Quillivant to the VDP [Vendor Drug Program] Formulary and the Preferred Drug List.
“These steps would effectively allow Medicaid providers to prescribe Quillivant to their Medicaid patients and would streamline the prescribing process by eliminating the need for the treating doctor to go through the burdensome process of obtaining prior authorization.”
Pfizer projected that Quillivant sales in Texas would significantly increase if the drug were added to the Texas Medicaid Preferred Drug List, as Texas was a “populous state with a disproportionately high percentage of children covered by Medicaid,” according to the complaint.
The Civil Medicaid Fraud Division of Paxton’s office undertook the investigation.
Suzanne Burdick, Ph.D., is a reporter and researcher for The Defender based in Fairfield, Iowa.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.


