To nobody’s surprise, this was later called “an honest mistake.”
The cowardly, incompetent FDA relied on its friends in the blood bank industry to both advise on the decision-making and to do voluntary testing of the blood supply. Mandatory testing did not become law until February 4, 1988, nearly three years later, after thousands had become unnecessarily infected and died as a result. It is hard to know whether the FDA or the blood banks committed a greater crime against humanity.
This government failure is especially tragic since the blood bank industry is immune from tort liability through shield laws, enacted by Congress. Thus, government regulation is the only currently existing mechanism for consumer protection. The IOM indicted the FDA for relying solely on the industry it regulates for advice. This should have been sufficient warning for why it was a bad idea to grant the pharmaceutical companies’ complete immunity for harm caused by childhood vaccines through the 1986 National Childhood Vaccine Injury Act.
Yes, that’s right.
The regulators (NIAID, CDC, and FDA) in charge of protecting the consumer against vaccine abuses again left that responsibility to the industry foxes in the chicken coop.
All these same organizations were asleep at the switch with fifteen years of warnings of the dangers of a coronavirus epidemic. No test or therapeutic studies were funded in preparation. Instead, as always, these serial felons simply waited for the pandemic to strike down millions, then waited for the profit-guided vaccine industry to save us all. How long will this nightmare of unethical conduct of public health be allowed to continue? The world has been waiting almost forty years for that miracle HIV vaccine to save us all. One must fund the development of therapeutics to use at the beginning of a pandemic and before if we have had warnings.
***
For hemophiliacs, corporate greed and regulatory incompetence provided a double whammy.
These desperately ill patients needed a medication which allowed their blood to clot, called anti-hemophiliac factor (AHF). Since AHF was produced from pooled plasma from thousands of blood donors, it was likely that AHF was contaminated with blood borne pathogens. The assumptions in the hemophiliac community about the medically acceptable risks of this blood product transmitting viruses, such as hepatitis, led to a general failure to react to reports of a new infection among large groups of people.
Harvey Alter, now a Nobel Prize laureate, who we were to meet later, along with many other hepatitis doctors, stated of the problem, “We were used to dealing with hepatitis. You get it from blood. No one got sick right away … and it was not life threatening.”6
Hepatitis was an acceptable risk.
And HIV/AIDS was put in the same category.
How could they do this?
Had they never looked under a microscope, as I had done, and seen the rapid lysis of T-cells from AIDS, unlike any other viral disease in human history? The IOM report found that scientific uncertainty allowed a pattern of responses that were very cautious and exposed the decision makers and their organizations to a minimum of criticism, if they were later found to be wrong.
I understand that in any crisis, mistakes will be made and opportunities for appropriate response will be squandered. However, where there are structural problems in the decision-making process, they must be pointed out. The decision-making committees of public health had members representing blood banks and the manufacturers of blood products, but no opposing input from consumers, independent scientists, or even from the FDA. In fact, the FDA was letting the industry self-regulate itself.
There was enough time to correct any of these decisions, but the accumulating evidence was not critically analyzed. From 1983–1985, there is no evidence that any of these decisions were being made by the top leadership. One of the difficulties with using “experts” to give advice to government agencies is that these experts develop close relationships and accumulate favors with experts on regulatory agencies and the industry itself.
The most astonishing FDA decision was not to demand an automatic recall of AHF products linked to an infected donor.7 So, throughout the 1980s and early 1990s more than ten thousand US hemophiliac patients became infected with HIV.
In March 1983, Baxter Healthcare was granted a license for heat-inactivated AHF, but Bayer/Cutter continued using the unsafe AHF, while bad mouthing the heat-inactivated AHF. In October 1984, a Cutter study found that their heat-inactivated product killed HIV, while 75 percent of the patients who used the unheated products eventually tested positive for HIV.
In November 1984, Cutter told overseas markets in Asia, Latin America, and Europe that “we must use up stocks of unheated AHF before switching to safer heat-treated blood products.”8 Why? Was it done for purely monetary gains? Of course!
In May 1985, when the FDA realized that companies were still selling unsafe, non-heat-treated materials, they told the companies they wanted it stopped, but did not alert the public.9
However, the damage was done, and people continued to get infected with contaminated AHF around the world for a decade.
***
Meanwhile, Judy Mikovits, working for Upjohn Pharmaceuticals at this time, and a few of the lead scientists, Janie and Steve, saw an urgent need to test the Upjohn biological products made from human blood.
One such product was called ATGAM, human and thymus globulin made by injecting human T-cells (the same cell targeted by HIV) into horses and purifying the T-cell antibodies. ATGAM is still used today to treat some patients with severe aplastic anemia, a potentially deadly blood disorder, where several cell types in the peripheral blood are poorly produced.
State officials in Michigan had proclaimed there was no HIV virus or AIDS in the entire state. This was a ludicrous statement at the time, as Judy had to go no further than her hairdresser in Michigan to find somebody who had AIDS.
Had she inadvertently stumbled onto the single gay person in Michigan with AIDS?
Judy’s proposal to Upjohn on the ATGAM issue was to spike a batch of ATGAM with purified HIV, then test it as it went through the manufacturing process to demonstrate a six-log reduction of detectable virus.
Judy and I tested the product after various stages of the manufacturing process, then at the end. We added some steps to the process to ensure a virus-free product and Upjohn accepted the proposal. Our research showed the product was safe under their manufacturing process, but we added some extra steps as a precaution.
Since there was no HIV in Michigan (wink, wink), it was agreed that Judy would conduct the experiments in my Biosafety Level 3 Lab at the NCI. Judy would fly out on Monday morning, using the Upjohn private jet, on which top executives would fly for their weekly meetings with the FDA. It was all very hush, hush, as nobody wanted to say the word HIV. The Upjohn officials, all dressed up in their three-piece suits, would stare in confusion at this twenty-eight-year-old blonde woman in tennis shoes and jeans, carrying a backpack, who would chat amiably with them about sports or other issues in science, but reveal nothing about what she was doing. When the plane arrived at National Airport (now Reagan National), a rental car would be waiting for her on the tarmac and she’d speed off to Fort Detrick on her mysterious mission.
So, it was very clear to us the FDA, NIAID, and CDC were at fault and knew exactly what was happening but would simply say that this is mere hindsight. To those of us doing the science and not prone to making unfounded, profit-oriented assumptions, it was not hindsight.
The IOM report of the failure with the HIV-contaminated AHF drug found that there were several risk reduction strategies which were not pursued, or even recommended. As the IOM report stated, “the perfect should not be the enemy of the good.”10
Obviously, Dr. Fauci, who was a significant part of the AIDS failures, simply forgot to implement these risk reduction strategies in his latest pandemic with his attack on the Henry Ford Health study, which showed that hydroxychloroquine and corticosteroids were effective in lowering the COVID-19 death rate, as flawed.
In direct opposition to the IOM report, Fauci said health officials should rely on the gold standard of a randomized, placebo-controlled study. The results with interferon type I and III and ivermectin were also ignored.
How strange it is then, that in 2015, Dr. Fauci and the FDA ignored a double-blind, placebo-controlled study showing that Suramin, a medication in use for more than a hundred years, designated by the World Health Organization (WHO) as an “essential medicine” and manufactured by Bayer/Monsanto, could be effective as a treatment for autism. We have known since 1980 that Suramin was not only a potent inhibitor of the reverse transcriptase enzyme, but also a potent inhibitor of the mouse (murine) leukemia viruses.
Hydroxychloroquine (HCQ) and steroids, along with interferon alpha, ivermectin, and antibody cocktails, may not have prevented the development of COVID-19 in millions of people, but would have prevented the spread of SARS-CoV-2 and greatly reduced the suffering and recovery time of those afflicted. You might be surprised to know that in 2015, Dr. Fauci even went so far as to call HCQ a “vaccine” against the original SARS virus.
In addition, the CDC rolled out a contaminated unvalidated COVID-19 PCR test as the new Gold Standard for diagnosis of an infectious disease, which is what happens when we do not allow others to make competing products.
***
During this pandemic, it was and is not only unethical but criminal to hide behind perfect clinical trials, particularly since the decision makers’ friends in the pharmaceutical industry have been manipulating clinical trial endpoints for the success of their own products’ trials for decades.11
The concept that agencies like the FDA should not rely upon the entities they regulate for the analysis of the data led to further questions in the search for AIDS drugs. Under enormous pressure from patients, the FDA fast-tracked the review of azidothymidine (AZT). The toxic effects of AZT on bone marrow suppression, anemia, and T-cell death were already known and observed during clinical trials. Yet, this drug was still deemed safe and the FDA pushed for approval, while safer and more efficacious medications, like interferon alpha and Peptide T, not only did not receive FDA approval, but their use was forbidden or made illegal. Again throw out the good searching for the perfect.
Not unexpectedly, severe toxicity from AZT resulted in 50 percent of AIDS patients having to be taken off the drug, with many of them dying.12 Despite some early benefits for AIDS patients, AZT was not found to benefit patients enough. In many instances, the virus had mutated to resist the drug.
Despite this, Dr. Fauci, who had published results that in some cases AZT did not block HIV replication in vitro, still pushed for prescribing AZT to asymptomatic people.13 This caused many AIDS doctors to be outspokenly dumbfounded. Once again, with COVID-19, Dr. Fauci and his fellow criminals in the FDA have used the same playbook with hydroxychloroquine (HCQ), ivermectin, and remdesevir, when remedies like HCQ and ivermectin with much better safety profiles were ignored or made illegal.
The high cost of AZT (at the time the costliest drug on the market), the lack of health insurance for infected individuals, the poor therapeutic window, slow pace for drug discovery and implementation, and social stigma attached to AIDS led to the rise of advocacy groups like ACT-UP, which I mentioned in an earlier chapter.
The important parts of the ACT-UP agenda included: that people from all affected populations at all stages of HIV infection be included in clinical trials or use parallel tracks; that no more double-blind placebo trials be necessary in fatal diseases because they are unethical; that drugs would become available when proven safe (as was the FDA’s only mission from its inception); and finally, that drug therapies must be paid for by private or public medical insurance.
Progress was slow, with officials stonewalling protestors until they invaded the NIH in May 1990. With shouts of “Fuck Fauci!” rising from the crowd, changes were being forced on the medical community by the patients for the first time. If only those changes had not been ignored over the past three decades as all liability was removed from the manufacturers of vaccines, but also from harm caused by the nation’s unsafe blood supply and biological therapies, untold suffering and millions of lives could have been saved.
In 1990, by the CDC’s own definition, women did not get infected with HIV, they just died of AIDS.14 One of the least known of ACT-UP’s priorities was the demand that the definition of AIDS be changed so that HIV-infected women could get treatment and support.
In 2020, forty years since the beginning of the HIV/AIDS epidemic, AIDS remains the leading cause of death of women of reproductive age around the world.15 This tragedy is the result of gender prejudice, sexual violence, educational discrimination, and lack of reproductive health services. Why is so little being done to recognize the rights of women?
The public believes that government health agencies are thinking and planning far into the future to deal with pathogenic threats to the citizens. Good luck with that fantasy.
The improvements suggested in the IOM report on how the public health agencies dealt with the threat to the blood supply from HIV have only received lip service. Instead, it’s the same “old boys club,” where corporate greed is an important criterion in all decision making and where unethical if not criminal conduct occurs with impunity.
***
In August 1987, Judy’s beloved stepfather Ken was diagnosed with stage four prostate cancer.
Ken was in his early fifties and did not want his children to know, as they’d lost their mother to aggressive breast cancer when she was in her thirties. As Judy and Kent wrote in Plague of Corruption, she was in a wee bit of trouble at Upjohn for throwing a notebook at her boss, Frisbee style, when he told her that she was “legally, ethically, and morally” required to do what he said, even if meant she would lie and misrepresent data. Here’s a hint to anybody who might decide in the future to employ Judy.
Never ask her to lie.
It won’t end well.
Judy came back to the East Coast to help her mom and stepfather. I funded her work at the NCI and there was also the possibility that some cutting-edge research might hold a miracle for her stepfather. Judy also decided to begin graduate school, disgusted by what she’d experienced at Upjohn. I knew it wasn’t and would not be easy for her to overcome the demons of those degrading misogynistic experiences at UVA, but I also knew once Judy made a promise, nothing would stop her from doing all in her power to achieve the goal.
Thus, the proverbial bad penny returned to my life, bringing her insane work ethic with her. Normally, she’d arrive in the lab at 4 or 5 a.m. If I arrived earlier than her, she’d be irritated and come in even earlier the next morning.
I used to think it was due to Judy’s competitive nature, but years later she explained she didn’t want to miss anything and liked to know before I arrived that she had drawn the same conclusion as I had about the previous day’s experiments. I thought about Lew Jacobson and my days as a graduate student, when I’d been much the same way. On the rare days she overslept, I’d stay in my car until I saw her bike roll up to the back entrance of the lab.
We recharged and worked off any frustrations of the morning by exercising midday, which could include running, weights, pick-up basketball, or beating me and several other men relentlessly in squash. Then, around 5 p.m., if it wasn’t softball season, she’d relax by biking home in the evenings, and then train aspiring cyclists riding centuries (hundred-mile bike rides) on the weekends.
I considered what might be a good research project for her. Judy disliked counting blood colonies under a microscope, so it had to be a virus project. At the time, AIDS was defined as a disease in which certain blood cells, helper T lymphocytes, were infected by HIV and gradually depleted, resulting in the fatal breakdown of the immune system. Several things did not add up. For example, there was a condition called “neuronal AIDS,” which didn’t make sense because of the absence of T-cells in the brain, as well as the fact that there was only a relatively small number of T-c
ells which were affected in AIDS patients.
As Judy said to me at the time, “When we know that only one in ten thousand T-cells are infected, the medical community responds by calling it a ‘bystander effect.’ Clearly, there’s another shooter in this scenario, a key immune system target that people are missing.” We hypothesized a key was the monocyte macrophage and she decided to study the role of macrophages in HIV infection with the hypothesis that the numerous changes in the brain of AIDS patients resulted from localized viral replication of the monocyte macrophages of the brain called microglia.
Judy started driving from Frederick, Maryland to George Washington University in Washington, DC and back to finish her work in Frederick. If it wasn’t rush hour, it was an hour-long drive, but when traffic was heavy it usually took two hours. During that time, we also visited her stepfather Ken in the hospital. I remember him saying, “Frank, shake my hand, you can’t do anything else for me.” I have remembered and rued that visit a long time.
Ken’s nickname for Judy was “Crash” because as he often liked to say, “Judy’s mouth always gets Judy’s body in trouble.” There was another reason for that nickname because once, when Judy got into a serious car accident, she called Ken instead of her own mother because not only did she have glass in her underwear, but she didn’t want her mother to worry or kill her for being stupid.
I would always laugh, not realizing I was much the same way, protesting the many injustices at work and yet still being thrown to the curb.
As her written comprehensive exams needed to continue in the PhD program approached, Ken died. I still vividly recall driving to and from the funeral procession with Judy and her asking me to drill her with biochemistry questions. That’s the kind of focus she had, even as she was grieving.
Due to her extraordinary efforts, Judy’s research thesis was a rousing success. And it resulted in the publication of three important papers.16 Using a cell line model of monocytoid cells, she found three levels of HIV expression: 1) latent, that is no HIV viral expression; 2) restricted expression of viral RNA, but few viruses produced; and 3) productive expression of HIV.
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