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The U.S. Food and Drug Administration (FDA) is “suffering from dysfunction and is failing to do bare minimum to carry out its core mission, which is to make certain our nation’s food and drug products are safe and effective,” according to Rep. James Comer (R-Ky.), chairman of the U.S. House of Representatives Committee on Oversight and Accountability.
In his opening remarks during a hearing Thursday on oversight of the FDA, Comer said the FDA “appears consistently unprepared for certain crises.”
He cited the agency’s failures to address the infant formula crisis and to prepare for and respond to “drug shortages for essential medications used to treat infection, heart disease and cancer.”
FDA Commissioner Robert Califf was the sole witness to testify during the hearing, which was dominated by topics such as the risks of tobacco and vaping products.
In his opening remarks, Califf focused on what he referred to as the agency’s work in four main areas, including “addressing vulnerabilities in the supply chain,” “reversing the decline in our national life expectancy,” “accelerating effective treatment for thousands of rare genetic diseases” and “undertaking the most significant reorganization in FDA history with a focus on human foods and improving oversight of all of our regulated industries.”
Neither Comer nor Califf addressed COVID-19, bird flu or vaccine safety and vaccine-related adverse events during their opening remarks.
However, during questioning, Califf addressed lawmakers’ questions about the effectiveness of ivermectin, hydroxychloroquine and vitamin D as COVID-19 treatments, bird flu, the dangers of artificial intelligence and the proposed “pandemic treaty.”
Remarking on the content of the hearing and Califf’s testimony, cardiologist Dr. Peter McCullough told The Defender, “Issues such as vaping should be tabled until the FDA removes COVID-19 vaccines … from the market.”
“Dr. Califf’s largest regulatory concern is the burgeoning number of injuries, disabilities, and deaths that have occurred after COVID-19 vaccination,” McCullough said. “Lack of COVID-19 vaccine safety and calls to remove the products from the market dominate his role as top drug and vaccine safety regulator.”
‘Goal of Big Pharma is to get people hooked for life on their products’
Rep. Paul Gosar (R-Ariz.) asked Califf to respond to the FDA’s continued push for the public to receive updated COVID-19 vaccines.
“It seems that the goal of Big Pharma is to get people hooked for life on their products, whether it be annual flu or COVID-19 vaccines, perpetual statins to lower cholesterol, beta blockers for high blood pressure or expensive, never-ending cancer treatments,” Gosar said.
Califf launched into a defense of the COVID-19 vaccines in response:
“I’ll remind you, the initial vaccine trial that led to the EUA [emergency use authorization] did show a dramatic reduction in the rate of infection in the two groups. The virus then mutated. But the good news is now we have a progression of overwhelming evidence in every country, including the United States.
“If you’re up to date on your vaccine, you’re less likely to be dead. You’re less likely to be admitted to the intensive care unit if you live in a county with a higher vaccine rate, the mortality rate is lower … So, when you compare the two, yes, vaccines have side effects, the risk of being dead is lower if you’re vaccinating.”
Dr. Mary Talley Bowden, an otolaryngologist and sleep medicine specialist in Houston, disagreed.
She told The Defender “Califf lied about the efficacy of the COVID shots,” adding that the “95% effective claim” of COVID-19 vaccines was “an absolute risk reduction in the rate of infection from only 0.88% to 0.04%.”
“Dr. Denis Rancourt looked at all-cause mortality following the COVID shots in 17 countries and found no positive association between taking the COVID shot and reduction in mortality. In fact, he found the opposite: All-cause mortality increased following the COVID shots,” Bowden said.
Califf also responded to a question from Gosar about the recent settlement in which the FDA agreed to remove content from its website and social media accounts discouraging the use of ivermectin to treat COVID-19, claiming the FDA “didn’t retract everything we had to say about ivermectin.”
“If you look at the randomized trials of ivermectin, and there are many of them now, there is no benefit of ivermectin in the treatment of COVID. That’s a statement, just a fact,” Califf claimed, later adding:
“I should also point out [ivermectin] also has benefits for humans with worms, which is a huge problem in Asia. So, it actually won a Nobel Prize because it’s an amazing drug both for animals and humans who have worms.
“There was a good reason to think it may work in the case of COVID, and that’s why thankfully the community, including the NIH [National Institutes of Health], did a number of randomized clinical trials. There’s just no benefit … There’s nothing wrong with thinking it might work, it just didn’t.”
Califf also denied that the FDA’s advice was intended to discourage doctors from prescribing ivermectin as a COVID-19 treatment. “What we’re not doing is telling doctors what they have to do. Doctors have the right to prescribe off-label,” Califf said.
Bowden again accused Califf of lying:
“During the pandemic, government doctors like Califf dictated who would get treated and how, from the safety of their homes over Zoom meetings. They have consistently rejected input from doctors with extensive experience treating COVID patients and have simply cherry-picked published data to fit their agenda.
“In reality, there are 49 randomized control trials studying ivermectin for COVID — 35 of these show a benefit.”
Responding to a question from ranking member Rep. Jamie Raskin (D-Md.) on the use of hydroxychloroquine as a COVID-19 treatment, Califf said.
“Basically, the same story. There was really exciting preliminary work in the laboratory that said hydroxychloroquine may have efficacy against COVID. So, the randomized trials were done, unfortunately, no benefit. Again, nothing wrong with thinking it may work and trying it out in a randomized trial, but then we have the data now.”
Committee members also addressed vitamin D as a treatment for COVID-19. Responding to Rep. Glenn Grothman (R-Wis.) about “the lack of emphasis from the public health establishment on having vitamin D,” Califf said, “this is really not in our domain.”
“We don’t regulate the practice of medicine that’s determined by the medical profession. And other agencies may have more to say about that.”
Califf told the committee:
“There are many diseases for which if you measure vitamin D levels, the higher the vitamin D level, the lower the risk of the disease. But it turns out when randomized trials have been done … for most diseases, it turns out there is no difference.
“And the randomized trials so far in COVID, to the best of my knowledge, have not been positive. But again, I want to make the point, this is not something FDA regulates. It’s a dietary supplement, basically a vitamin. It’s on the market, it’s freely available in your local store, and that’s between the doctor and the patient.”
Califf: FDA stockpiles of bird flu vaccine suitable for potential outbreak
Rep. Maxwell Frost (D-Fla.) was the only committee member who addressed the recent bird flu scare, asking Califf how the FDA is coordinating with other federal agencies to provide accurate information to the public on this issue.
“Avian flu has been around for a while, but it’s only recently that it’s now infected cattle and now cattle in multiple cows in multiple states. And so, this is really an all-of-government effort,” Califf said. “There are Zoom conferences multiple times a day” at present, involving the FDA and other federal agencies.
“We’re all working together, and you should see frequent communications as we work through this … The most recent episode with the cows is a relatively new thing … we’re starting with a lot of uncertainty and working our way through it,” Califf said.
Califf also referenced the FDA’s stockpile of bird flu vaccines. “If you look at the composition of this virus, there’s nothing in it that should confer resistance to the current antivirals that we have stockpiles [of],” Califf said.
Califf refuses to commit to opposing ‘pandemic treaty’ or receiving Big Pharma funds
Citing a “potential threat to U.S. sovereignty,” Rep. Scott Perry (R-Pa.) asked Califf to address the “pandemic accord” — widely known as the “pandemic treaty,” under negotiation by World Health Organization member states.
“Would you commit before the committee today to pledge not to adopt policies included or pursuant to the treaty until such time and if such time as that treaty would be ratified by the United States Senate?” Perry asked.
Califf responded, “I’m not sure how to answer that question given the complexity of what you said, but it’s hard for me to imagine that we would do something at FDA that’s not a government policy.”
On the growing role of artificial intelligence (AI) tools in medicine, Rep. Stephen Lynch (D-Mass.) asked Califf what the FDA is doing to guard against the dangers posed by the “widespread adoption of AI.”
“I’ll have to contain myself here because you may know that I worked at Alphabet or Google during the five years between my two FDA stints and was very heavily into this,” Califf said. “And I think it’s going to be a huge benefit, but also with a huge risk on the other side if it’s not regulated. The first line is self-regulation by the industries.”
Noting that Califf previously received “consulting fees from Merck, AstraZeneca [and] Biogen,” Rep. Ro Khanna (D-Calif.) asked Califf to commit that after his tenure at the FDA is over, he “will not take any money on consulting fees from Big Pharma.”
Califf responded, “I have a written record on this for two years. Beyond that point, we’ll have to see.” When further prodded by Khanna, Califf said he is “not looking to make money” but instead is “looking to contribute to the development of effective [treatments].”
Dr. Richard Bartlett, an emergency room director and former Texas Department of Health and Human Services advisory council member, told The Defender there were “many questions” lawmakers should have asked, but didn’t.
Bartlett listed 22 such questions, including “Why did the FDA try to withhold the Pfizer safety data from physicians and patients for 75 years?” and “Why is the FDA continuing to grant EUA after EUA for human experimentation when an effective treatment already exists?”
“Why has the FDA not alerted the public to the 1,200 diseases reported by Pfizer to be associated with the Pfizer mRNA shot?” Bartlett also asked.
Bowden said she “applauds the encouragement by Khanna to get Dr. Califf to commit to rid himself permanently of dirty money from Big Pharma” but “would have liked to see him ask specifics about Califf’s current financial relationships with pharmaceutical companies.”
She added:
“We need to know what steps the FDA took to censor and persecute doctors who challenged their statements. How much money did they pay PR firms, social influencers and social media companies to censor and attack us? What communications did they have with the Federation of State Medical Boards and state medical boards to target doctors prescribing ivermectin and speaking out against the shots?
“Why was the social media attack against ivermectin launched two days before the Pfizer shot received full FDA approval, five days before the Pentagon announced the military mandate and 19 days before Biden announced a mandate for all Americans working in companies with 100 or more employees?”
“Why won’t the FDA engage in a debate with community-based doctors who have collectively successfully treated hundreds of thousands of COVID patients?” Bowden also asked.
Watch the hearing:
