After my years in government, I learned to be skeptical of any pronouncement from the NIH which might reflect badly on them. But in those days, we had a functioning press, which might occasionally report on government misconduct. As reported on the front page of the New York Times on December 31, 1992:
After three years of investigation, the Federal Office of Research Integrity today found that Dr. Robert C. Gallo, the American co-discoverer of the cause of AIDS, had committed scientific misconduct. The investigators said he had “falsely reported” a critical fact in the scientific paper of 1984 in which he described isolating the virus that causes AIDS.
The new report said Dr. Gallo had intentionally misled colleagues to gain credit for himself and diminish credit due his French competitors. The report also said that his false statement had “impeded potential AIDS research progress” by diverting scientists from potentially fruitful work with French researchers.10
In what universe does Gallo escape punishment? But of course, he’s still allowed to speak as a leading scientist.
In the wake of Gallo’s unholy press conference of April 1983, members of the gay community visited Gallo to discuss how to limit the AIDS epidemic. Gallo threw them out of his office, saying they had caused the epidemic.
Shortly thereafter, the editor of the New York City gay newspaper Pride called me, stating they wanted to write a series of articles exposing Gallo’s behavior and wanted me to check the science before they published them. I was happy to oblige them. My honorarium for that bit of scientific work was a subscription to Pride, which arrived every week in an unmarked brown paper envelope. One of the magazines is still in my possession.
To help give this marginalized group a voice meant more to me than public praise, for through ACT-UP, they changed the scientific and medical response to the AIDS epidemic for the better.
CHAPTER SIX
Failed Public Health Response to HIV/AIDS
Give all the power to the many, they will oppress the few.
Give all the power to the few, they will oppress the many.
—Alexander Hamilton
History is a later event because those involved in the events:
Those who might be able to contradict what is accepted are no more,
Thus, the truth of history is a fable agreed upon.
—Napoleon
By 1985, the US government, Robert Gallo, and Anthony Fauci had gotten what they wanted by messaging scientific truths and throwing competitors under the bus for their own purposes.
The government got a scientific hero who justified all increased funding.
Gallo was recognized as a co-discoverer of HIV, theoretically putting him on the way to winning a Nobel Prize.
Because of his alliance with Gallo, Fauci secured a promotion to the directorship of NIAID in 1984.
There were persistent rumors that the three final candidates for the directorship of NIAID were two members of the national academy and Anthony Fauci. In my estimation, the academy members were both far superior scientists to Fauci, as well as being men of outstanding character. The candidates were told they had to give up their laboratories in order to assume the directorship. The academy members withdrew and Fauci got the position by default and never gave up his lab, proving once again that Fauci’s word cannot be trusted.
One of the many terrible decisions made by President Reagan was to eliminate the retirement age for federal employees. As a result, Fauci has been a virtual emperor at NIAID for thirty-seven years, since before many of the current employees were born. The result of Reagan’s decision has been that the average age of the men in charge of medical research has substantially increased and women who could be leaders are essentially non-existent. Scientists know that most of the innovative, groundbreaking ideas come from younger researchers in any given field so as NIH becomes older it becomes less relevant.
One of the best things Reagan did, in the face of his drastic funding reductions, including a 25 percent reduction in the Health and Human Services budget, was to give increases for research funding. This led to an expansion of the Biological Response Modifiers Program (BRMP) at the Frederick Cancer Research Facility, directed by Dan Longo from 1985 until its final closure.
However, the program was effectively dismantled in late 1996 when the government declared in its infinite wisdom that the public did not need a translational research component!
The BRMP had basic laboratories to discover useful biological and clinical information, then quickly translate them into therapies. The enthusiasm in the program was so great that an after-work “Amazing Papers Journal Club” sprung up which the researchers eagerly looked forward to each week. They could share their latest findings with all the members of the program, from the most senior scientist to the most recent hire. The BRMP brought together clinicians and basic research scientists focused on understanding the response to therapies designed to modulate the immune system. The biological agents studied by many programs led to a great increase in the understanding of functional cellular immunology, particularly the activation of innate immune response to pathogens, or what we have come to understand better as an inflammatory cytokine storm.
It was the best program Judy and I were ever associated with at the NCI and we never understood why it closed. We were told only that translational research was not needed at the NCI-Frederick.
Sure, we wouldn’t want to “cure” cancer at the NCI, would we? What would happen to the jobs of all those researchers?
Our suspicion was that other, more politically connected scientists lobbied better than our advocates for those research dollars. The Society for the Immunotherapy of Cancer later honored our whole team at an awards ceremony at the Smithsonian National Museum of Natural History in 2010 where they said our team had, “imagined, developed and sustained immunotherapy of cancer for more than a quarter century and continued to make seminal contributions to the field.”1
When Reagan became president, America was the largest creditor in the world, and when he left, we were the largest debtor in the world. I believe his anti-government fervor, deregulation, and massive budget reductions fueled corporate America’s exceptional rise in wealth at the expense of the common man.
The “greed is good” approach swept through the health-care industry as it did every other segment of the economy.2 Twenty-five percent of the federal health-care budget disappeared in a single day, eliminating many worthwhile programs. For example, one program sent physicians into isolated, underserved communities. Reagan’s devastating budget cuts resulted in the closure of 250 community health centers and over six hundred rural and urban hospitals, leaving many of these communities without health professionals.3 Infant mortality increased and African American life expectancy decreased.4 During the Reagan years, 35 percent of Native American deaths were younger than forty-five years old.
One example of the disastrous results of these decisions was that, in the 1980s, it was claimed that the United States had brought tuberculosis under control. This statement was based on little or no evidence that I could ever discover. As a result, drug resistant TB, which develops when patients do not complete the standard therapy regimen, surged, especially in poorer areas. Because of these budget cuts, Native Americans were 400 percent more likely to die of tuberculosis than other Americans.5
I believe Reagan’s “pull yourself up by your bootstraps” philosophy also encouraged people to view public health programs as a handout for the poor. The legacy of medical misogyny and racism has a long history in our country, and these devastating cuts made the situation even worse. Minority groups and people of different sexual orientations are generally those most damaged by the system and more reluctant to seek treatment for problems. Unfortunately, it is among the conditions of poverty that most diseases arise.
Before COVID-19 hit in 2020 many people were dying in America, with 70 percent of these deaths linked to chronic diseases or medical “mistakes,” such as the wrong medication o
r dosage. In 2018–2019, it was estimated that these medical “mistakes” were the third leading cause of death in our country with, depending on the study, between 250,000 and 440,000 victims.6
Several studies have shown a curious pattern that American citizens in the twenties and thirties do not have the same robust health that their parents did.7 Who is in control of regulating air quality, food safety, water purity, and the very medications we put into our bodies? All these things have become more or less privatized, legal protections have been loosened, and companies have been given “immunity” from being sued, and I credit much of this to Reagan’s mania for deregulation. It seems like-minded Democrats have no interest in fixing the system either, I have reluctantly concluded. Consumers have no protection from the harm inflicted by unaccountable corporations, and as a result, we are getting sicker and sicker.
Ironically, as an editor of the New England Journal of Medicine remarked in 1986, a medical industrial complex was developing because of these actions.8 Reagan’s policies allowed drug makers, dialysis companies, and others providing profitable, high-cost medical treatments to greatly expand their influence.
In my estimation, it all began with the Bayh-Dole Act of 1980 signed into law by President Jimmy Carter. This act allowed universities, small businesses, and other non-profit organizations to elect to retain any patentable invention made with federal funds. That’s right. The taxpayers funded it, but it’s owned by somebody else. The institution retaining the title must commit to commercialization of the invention. The university is also required to share a portion of the royalties with the inventors and must also dedicate a portion of the money earned to laboratory purposes, such as buying new equipment and performing maintenance.
In the forty years since the act’s passage, Big Pharma and the universities have not become centers of innovation, as the act was intended to do. In fact, none of the universities or Big Pharma companies which received money because of Bayh-Dole created their own drugs or therapies.9 A study reviewing the 210 medicines approved by the FDA from 2010 to 2016 found that all of them had been developed from NIH-funded research.10 In other words, the money from the inventions went somewhere other than to the taxpayer. The money went to Big Pharma and the stockholders, not the US taxpayers, the patients and stakeholders.11 In my estimation, universities aren’t using the money as a public trust to fund the next generation of therapies. Instead, Big Pharma is probably just lining the pockets of its executives or Wall Street profiteers.
For example, the NIH funded sixty-two million dollars for the development of a Hepatitis C drug to a company called Pharmasset. That company was then bought for eleven billion dollars by another company, Gilead, which then decided to price the treatment at six figures, even though the treatment itself costs less than a hundred dollars to produce. From a New York Times article on the sale:
Gilead Science made a bold move on Monday to capture the lead in developing the next generation of hepatitis C drugs, agreeing to pay $11 billion in cash for Pharmasset.
The treatment of hepatitis C has undergone a revolution this year, with new pills from Vertex Pharmaceuticals and Merck sharply increasing the cure rates and also often cutting the required duration of treatment. But those new drugs still must be used with alpha interferon, a type of drug injected once a week that can cause severe flulike symptoms and other side effects.
Pharmasset, based in Princeton, N.J., is pushing to develop the first all-oral treatment regimen, doing away with the need for interferon.12
Stories like that turn my stomach. Why are scientists interested in becoming billionaires? This is not science; it’s commerce.
This is what our tax dollars are being spent on.
Seed money goes to companies, then they make billions by jacking up the price of their treatment.
Is it clear why so many scientists, like Harold Varmus, travel so easily between government work and outside groups? The system works great for insiders who want to cash in. Maybe somewhere in their souls they believe they’re helping people, but I doubt it.
Furthermore, by allowing universities and Big Pharma to have patent monopolies, Bayh-Dole inhibited the open flow of knowledge so other scientists could not use the information to develop better and safer therapies, or ones that cost less.
Do you really believe that these organizations will kill the goose that lays so many golden eggs for them?
For many common diseases, progress in treating them has slowed to a crawl. The laborious construction and development of knowledge paid for by the taxpayer must be communicated in order to fulfill the scholar’s obligation.
Another example is that since the development of recombinant insulin in 1977, age-related deaths due to diabetes have increased. The $250 billion industry for the treatment of diabetes has inhibited a public health campaign to greatly decrease the incidence of diabetes through dietary changes.13 This slow-down in innovation has had a harmful effect on urgent research needs in essentially all chronic and infectious diseases.
Since only about 5 percent of drugs designed to treat neurodegenerative diseases make their way to clinical trials, Big Pharma has essentially stopped all research into these diseases.14 Second, there exists a drought in alternative strategies of antibiotic drug development. Drug companies do not do this research because antibiotics are not very profitable, in that they are only needed for a short time and the pathogens become resistant to them. Those which do remain in use eventually go off-patent and are inexpensive, thus not greatly contributing to the company’s bottom line. Other technologies, like specific bacteriophages which would be used to kill drug resistant bacteria, are not being pursued with any vigor.
A publicly funded system of drug development in this arena is urgently needed and would be less costly to the taxpayers.
The worst result has been the corruption of evidence-based medicine, which results in the all-too-often killing of the patient for profit. In 2002, Dr. Relman, former editor-in-chief of the New England Journal of Medicine, said,
The medical profession is being bought by the pharmaceutical industry, not only in terms of the practice of medicine, but also in terms of teaching and research. The academic institutions of this country are allowing themselves to be paid agents of the pharmaceutical industry. I think it’s disgraceful.15
Dr. Relman’s replacement as editor-in-chief at the prestigious publication sounded a similar warning note in 2009: “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians.”16
It is not possible to discuss all the reasons for this sorry state of affairs, but I can briefly mention some of the most glaring examples. They would include: the rigging of outcomes of clinical trials, selective and biased publications, commercials for drugs posing as publications written by industry scientists (learned from the tobacco industry), and the outright bribery of journal editors. As has been said by many others, some universities and doctors have become willing participants in this game of killing for profit.
Never has this corruption been more apparent to me than during the COVID-19 crisis.
But surely, we can expect our huge number of regulatory bodies to protect us, like the Centers for Disease Control and Prevention (CDC) or Food and Drug Administration (FDA)?
We cannot. Since Reagan’s time these agencies have been consistently weakened to the point where they have become inept and useless. In my estimation, Republicans do the most damage to kill these agencies, but by the same token, when Democrats come to power, they do little to restore them.
For me it’s easy to identify at least three “man-made plagues” caused by this lack of effective oversight.
First, many FDA failures have contributed to the opioid epidemic. Opioid use disorder is now common in patients, and opioid overdose is the leading cause of accidental death.17 Proper oversight could have prevented most of this tragedy, as could the federal legalization of cannabis and FDA appro
val of Peptide T and low dose interferon alpha.
Second, after lawsuits against vaccine manufacturers and health-care providers threatened to cause vaccine shortages, the National Childhood Vaccine Injury Act of 1986 was passed, spearheaded by Democratic Congressman Henry Waxman of California and reluctantly signed into law by President Reagan.18 This act removed all legal liability from vaccine makers and instead put the federal government on the hook for any vaccine injuries, creating in effect a special “Vaccine Court” with its own rules of evidence and capping damages. This was tantamount to letting the fox guard the henhouse.
With the Department of Justice and its battalion of lawyers deployed against the distraught and exhausted parents of vaccine-injured children in what was claimed to be a “no-fault system” of compensation, it was clear that no incentive existed for vaccine makers to improve the safety of their products.
A counterpoint to this act was occurring at the time because the “blood shield laws” financially protected the blood banks for giving HIV to patients through a contaminated blood supply.
Third, in what I consider one of the most cynical and tragic of the man-made plagues, I talk about the so-called “War on Drugs.” Even from its inception, it was a scam. For decades, the federal government has secretly engaged in a shifting series of alliances with some of the most notorious drug cartels to ever exist, often providing them with the highest level of protection, usually through the CIA.19 This included cartels run by the Mexicans, Panamanians, and Columbians. American drug agents were allowed to be captured and killed by these cartels, in what I consider to be the ultimate act of betrayal.
While Nancy Reagan was imploring inner-city youth to “just say no” to drugs, her husband was running a secret war in Nicaragua, financed by the Contras who were selling cocaine in American cities. This resulted in a five- to ten-fold increase in the number of people jailed for drug offenses.20
Ending Plague Page 9