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Reposted
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The FDA's War Against America's Health
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https://substack.com/inbox/post/151965456
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Story at a Glance:
•In 1906, the first FDA (Food and Drug Administration) was created in response to massive public protests against adulterated food and drugs (e.g., rotting food partially preserved with food additives or counterfeit consumer products). To stop it, food industry lobbyists attempted every tactic imaginable, eventually taking over the Department of Agriculture and in time forcing the dedicated public servant leading it (Harvey Wiley) to quit. Because of this, many toxic food additives Wiley fought against gained “generally recognized as safe” (GRAS) status and remain in use today.
•The handicapping of the FDA came to a head in 1962, when thalidomide was just barely prevented from devastating America’s children, prompting Congress to give the FDA much broader powers to police the safety and efficacy of drugs.
•Unfortunately, this law backfired, as the FDA created an impossible to reach standard of efficacy that it selectively enforced to protect the pharmaceutical industry and simultaneously began utilizing increasingly brazen (and illegal) police tactics against anyone promoting effective natural therapies.
•Because of this, many life-changing medical therapies (discussed throughout this article) were blacklisted by the FDA and faded into obscurity. This, along with the FDA’s tendency to push unsafe and ineffective therapies (e.g., vaccines or antidepressants) onto the market regardless of how much data argued against doing so, led to the FDA becoming the most protested agency in the federal government.
•Nonetheless, every attempt to fix the FDA failed. In this article, I will review the structural issues that have perpetually caused the FDA to succumb to incompetence and corruption. I propose potential solutions that can utilize the unprecedented window created by the Make America Healthy Again movement to end the FDA’s war against America’s health.
For most of my life, I have observed the FDA belligerently suppress natural treatments and any unorthodox therapy which threatens the medical monopoly while simultaneously railroading through a variety of unsafe and ineffective drugs regardless of how much public protest the agency meets. Consider for example, this 2004 Senate testimony by the FDA scientist who got Vioxx banned that accurately described exactly what would come to pass with the COVID vaccines two decades later:
As such, I do not hold the FDA in a positive light, especially given that during COVID-19, I (like many others) spent hundreds of hours trying to get the agency to allow the limited use of off-patent therapeutics for COVID-19—all of which ultimately went nowhere due to the unjustifiable roadblocks the agency kept putting up.
Note: given my familiarity with the FDA’s conduct, I felt the odds were against those endeavors succeeding, but I nonetheless exhausted myself supporting effective alternative therapies because I didn’t want to live with the knowledge I could have done something that could have prevented the unfolding tragedy but chose not to.
Over the last year, and especially since Trump won the election, I have received a lot of inquiries as to how the FDA could be reformed over the next four years. Given the importance of presenting the issue correctly, I’ve spent a lot of time trying to look at both sides of the question.
In medicine, “sensitivity” denotes how likely a test is not to miss something that’s there, while “specificity” denotes how likely a test is not to have a false positive. The great challenge with these two concepts is that there’s almost always a trade-off. Hence, as you increase one, the other reciprocally declines (e.g., as the PCR cycle threshold was increased on COVID tests, while it was harder to miss an infection, you also became more and more likely to get false positives from the tests—which is frequently what happened). In turn, many issues in medicine result from a poor balance between the two (e.g., Peter C. Gøtzsche made a good case that the sensitivity for routine breast cancer screening is too high, which leads to many women being erroneously diagnosed with dangerous breast cancers and subject to unnecessary treatments).
This same trade-off also exists throughout politics as there are often two conflicting positions (e.g., wanting a robust death penalty to serve as a deterrent against violent crimes but also not wanting to execute innocent individuals), and in many cases the eventual position that’s settled on is the result of a prolonged battle that eventually reaches a midpoint between sensitivity and specificity that while not ideal, is begrudgingly acceptable to both sides. In my eyes, the most important thing to understand about this dynamic is that it typically takes an incredible amount of work to reach the functional compromise that’s eventually settled upon, so if the existing process is scrapped (e.g. because people who are polarized on the issue can only see it from their side’s perspective) what follows (e.g., a complete lack of police enforcement in high crime areas) is often much worse than what preceded it.
In the case of the FDA, the agency’s situation has run into a similar issue—the FDA is expected to keep bad foods and drugs off the market while not blocking good ones from getting to the public. While this seems “simple,” it’s actually an incredibly challenging task, and the agency's history is one of it frequently abysmally failing at both—even when its leadership was composed of dedicated public servants who put the wellbeing of the American people before everything else.
Crime Against the Food Law
In the late 1800s, food producers would constantly sell adulterated food, while early pharmaceutical companies would sell a variety of proprietary medicines with secret ingredients that were inevitably things like opium and alcohol. Gradually, public outrage built around this, particularly since journalists and newspapers were willing to expose the issue (e.g., Upton Sinclair’s 1904 book The Jungle played a pivotal role in awakening the public to the immense problems with the meat industry).
Eventually, in 1906, the Pure Food and Drug Act was passed, which gave the Bureau of Chemistry the authority to ensure products sold in America were accurately labeled (e.g., no hidden opium or counterfeit foods), and that the food was not adulterated.
While the publicly strongly supported this law (e.g., the public did not want to eat potentially dangerous food additives), the industry resisted and relentlessly fought Congress not to pass the law, using many of the same lines and ploys we would see today (e.g., industry lobbies would always appear to shut down any attempts to legislate against this). Eventually, it passed with the compromise that the courts would be the means to challenge enforcement actions by the law.
The director of the Bureau of Chemistry (and thus the first head of the FDA), Harvey Wiley, felt very strongly about the dangers of chemical additives being put into our foods and in 1905, began a series of tests where he gave young healthy government volunteers (e.g., those most resistant to chronic poisoning) higher doses of the additives commonly being used in foods and was able to demonstrate the recipients gradually became ill.
Now, I want to say this, because I regard it as important. For fifteen or twenty days, or even longer in some cases, no visible effects were produced in what you would call "symptoms." The young men had normal appetites and performed their work without any discomfort, and had no complaints. After that time they began to eat their ration with some little discomfort. They were under obligation to do it, but they often said: "I wish you could let this go ; I don't want it." Their appetites began to fail. At the end every one of their appetites was very badly affected, and some of them were unable any longer to eat the full amount. Of course we never required anything that was impossible. They developed persistent headaches in most cases, followed by general depression and debility. It was extremely well marked in every instance.
It had a worse effect in the food when they knew it was in the food, because it became repugnant to them.
Unfortunately the effects in some cases were very much prolonged. Some of the young men—the experiments ended in July, or in June, the end of the year—and some of the young men complained even through the summer, and it was late in the autumn before they recovered their full normal appetites.
Note: the additives Wiley tested were boric acid and borax, salicylic acid (aspirin) and salicylates, benzoic acid and benzoates, sulfur dioxide and sulfites, formaldehyde, sulfate of copper (used to green produce), and saltpeter (nitrates).
In turn, a schism gradually developed in the scientific community, where Wiley (and many other respected doctors and physiologists) argued evidence showed those additives were dangerous. At the same time, a variety of scientists (who were paid off by the food industry) misleadingly testified to both Congress and then later the courts that the additives were “safe” or necessary (e.g., to prevent microbial food poisoning).
He came up and introduced himself to me [Wiley] and attempted to make some apology for his part in the activities of the Remsen Board [which was created to sabotage the FDA]. He realized very keenly the condition they were in, in espousing the cause of adulteration, becoming the paid agents of the adulterators, and incurring the universal condemnation of the press and the people of the country. Dr. Herter was then a very sick man. In a few months from that date he died.
Initially, the honest scientists (fully backed by the public) won, and Congress gave the Bureau of Chemistry the full authority to clean up the food. Still, the industry was relentless, and after failing in the courts (even in friendly jurisdictions), decided to target the executive branch directly, and successfully convinced the Secretary of Agriculture to sabotage Wiley’s work. At first, President Theodore Roosevelt vigorously opposed these efforts, and protected Wiley, but eventually he sided with the industry, and created a board (not authorized by the 1906 Food and Drug Act), which overrode everything Wiley tried to do.
Roosevelt’s about-face in turn, occurred for four key reasons.
•The food law that was passed was different from what Roosevelt had initially wanted (he wanted it to focus on meat, but the eventual meat provision that was added at the very end differed was considerably altered).
•He experienced an increasing number of complaints that the Food and Drug Act was costing industry and trading partners money.
•The Secretary of Agriculture forced Wiley to testify against Roosevelt’s position on importation taxes for Cuban sugar in front of Congress (which greatly offended Roosevelt).
•When Roosevelt was alerted to the fact Wiley wanted to remove saccharin from the marketplace (Roosevelt’s favorite sweetener), this exchange took place (which due to its consequences, tormented Wiley for decades):
This answer was the basis for the complete paralysis of the Food Law. Turning to me in sudden anger the President changed from Dr. Jekyll to Mr. Hyde, and said: "You tell me that saccharin is injurious to health?" I said, "Yes, Mr. President, I do tell you that." He replied, "Dr. Rixey gives it to me every day." I answered, "Mr. President, he probably thinks you may be threatened with diabetes." To this he retorted, "Anybody who says saccharin is injurious to health is an idiot"
Note: I share this passage to illustrate how things that go catastrophically awry can often result from one unfortunate domino rippling out over decades.
In turn, while courts, state governments, legislatures, and most importantly the public supported what Wiley wanted to do, key parts of the executive branch did not. As such, his agency’s enforcement ability continually declined (e.g., virtually no enforcement actions were allowed to be brought against the thousands of cases of food adulteration they encountered), his inconvenient scientific research (e.g., on the dangers of arsenic, food colorings and preservatives in foods) was blocked from publication, partially successful attempts were made to frame him and evict him from his post (along with other types of retaliation occurring against other government employees who tried to fight for clean food), and once Taft became president in 1909, it became even more challenging for Wiley to enforce the laws (e.g., Taft overturned the ban on selling fake whiskey).
Note: in parallel to this, the Department of Agriculture created a “Bureau of Soil,” which usurped the Bureau of Chemistry’s responsibility for analyzing soil around the country (but ultimately never got anything meaningful done). This was highly problematic as it both handicapped the Bureau of Chemistry’s ability to do research, but also removed the systematic analysis of the chemistry of the nation’s soils (which was/is necessary as the trace minerals present make a considerable impact on the health of the plants and those who eat them). Likewise, another agency (the Bureau of Standards) decided it wanted to expand its influence and partnered with industry to create a variety of profitable technologies (that lay outside its Congressional mandate) while simultaneously usurping the Bureau of Chemistry’s resources and responsibilities to advance its own interests.
Eventually, in 1912, Wiley, one of the most respected public servants in the country, resigned because he realized he could do more to help the public as a private citizen than within the government and in 1927, the Bureau of Chemistry was turned into the FDA (at which point it lost the ability to do many of the critical functions it had provided to monitor the safety of the country). Far later, Wiley wrote the book “The History of A Crime Against The Food Law” (which can be read here and details much of the same abhorrent behavior we see now happening over a hundred years ago). To quote one newspaper from the time:
He [Dr. Wiley] has been practically without power to put the law into effect against strong offenders. He has been humiliated by being overruled by his subordinates. He has suffered from an inefficient administration of the Department of which his bureau is a part; for the venerable Secretary of Agriculture is too old vigorously to administer his great Department. Yet Dr. Wiley, purely for patriotic reasons, has suffered this hindrance and humiliation till some change might come which should unshackle him. On the outside the bad food and drug interests—or some of them—have maintained a lobby in Washington, have kept "syndicate" newspaper writers in their pay to write about the unfairness and the injustice of the law and the unreasonableness and "crankiness" of Dr. Wiley. One such organization—or pretended organization—some time ago sent a threatening letter to all the most important periodicals, saying that large advertisers would withdraw their patronage if they published articles favorable to the law!
To illustrate how much things remain the same, a series of investigative reports have recently shown that the lobbyists from the processed food industry are now working fervently behind the scenes to block RFK’s nomination and prevent him from reforming the industry as Secretary of HHS. Beyond the tactics being remarkably similar to what Wiley detailed the industry doing over a century ago, they also touch on a central point Wiley raised—the only way to create change in this industry is to coax the public at large to demand it, as the moment you rely upon the members of the government to fix it, lobbyists will crush those efforts. In turn, had RFK not created the Make America Healthy Again Movement and been very strategic in how he leveraged its clout, we’d never have a chance of cleaning up the food supply.
Generally Recognized as “Safe”
Many of the additives in our foods are “generally recognized as safe” (GRAS) and as such, very little regulation exists regarding their widespread use, regardless of their toxicity.
At the time Wiley was trying to correct the nation’s food supply, he faced two primary issues.
The first issue was that the industry constantly made counterfeit foods to save money. For example, one of the major controversies Wiley dealt with (that Roosevelt backed him on) was people trying to make fake whiskey by taking grain alcohol (which was much cheaper to produce than whisky) and then flavoring it to taste like whiskey and labeling it as such (which Roosevelt did not approve of). Another was that oyster farmers would often float oysters in (polluted) waters to make them bulk up, a practice quite similar to how many meats now are injected with water to increase their weight, while a third was that small fish which were not sardines were being widely sold as such.
The second issue was that he (and many individual states) tried to outlaw many of the more problematic additives put into our foods. Unfortunately, due to the FDA getting corrupted from the inside and the Supreme Court eventually siding with the food manufacturers, those additives were propped up despite widespread opposition to them, eventually achieving GRAS status, and since then have been widespread in our food supply.
Note: those additives included sodium benzoate, sulfur dioxide, alum (potassium aluminum sulfate), sulfur dioxide, saccharin, modified corn sugars (which preceded high fructose corn syrup), saccharin, and nitrogen bleached flour—many of which were linked to cancer. Sadly, since 2000, nearly 99 percent of new food chemicals added to the food supply chain have exploited the GRAS loophole. Of these additives, I personally believe the widespread use of aluminum in processed foods is likely the most detrimental (due to it greatly impairing the physiologic zeta potential and causing micro-clotting throughout the body), and provides a key explanation for why you often see certain rapid improvements in individuals once they stop eating processed foods.
Wiley in turn, argued that if these additives could cause acute toxicity at higher doses, they likely caused chronic toxicity and accelerated aging at lower doses (yet remarkably paid-off scientists were able to argue that it was acceptable to give food additives at ranges just below their recognized toxic doses). Unfortunately, as the FDA became progressively more corrupt, Wiley’s arguments became forgotten, and these “safe” additives have chronically poisoned our society.
Note: a key point Wiley emphasized is that unhealthy conditions would cause organs to hypertrophy (enlarge) and lose their function—which was especially consequential once the organs responsible for detoxification began to fail.
One of the most remarkable things about this debacle was that the food industry would continually insist that the “safe” additives urgently needed to remain legal, as without them, producing their foods would no longer be possible. Yet, in case after case (e.g., sodium benzoate preserving ketchup or sulfur dioxide for preserving rotting fruit), competing companies arose that could produce the foods without the toxic additives. More importantly, they successfully argued that the primary purpose of the additives was to make it possible for an inferior quality (adulterated) product to be still sellable (e.g. by preserving something that was rotting like moldy grains or artificially coloring something that had visibly lost its nutritional value). In many cases, the companies actually switched to not using the additives because the products without them were of higher quality and, thus more popular with consumers.
“Are you Dr. Wiley?” I said I was. He said: "A few years ago I was the president of the Long Island Oyster Association. We regarded you as the arch-enemy of our industry when under your direction the ruling was issued that we should not add water to oysters that we shipped, nor place ice in contact with the oysters that we shipped. We considered you a devil incarnate. Now we know that decision was the salvation of our industry and I want to take your hand and congratulate you on doing the greatest service to the oyster industry that could possibly have been done. We are selling a dozen times as many oysters now in a perfect condition as they come from the water as we did at the time of your ruling."
The Williams Brothers Company later came to believe that benzoate, or any other preservative was entirely unnecessary in such food products as ketchup, sweet pickles, preserves, etc., and then withdrew as a party to the suit [that fought to keep benzoate in use]. Not only did Williams Brothers find that a preservative such as benzoate was unnecessary, but were convinced that permission to use it allowed food manufacturers to be very careless in their methods of manufacture.
In the early days of enforcement many of us thought, Dr. Wiley, that you were too radical in your ideas of pure food and felt that you were doing harm to our industry. When I look back over the changes that have come to the food industry during the past twenty-five years and see the great changes for the better that have come to our methods and our products, I wonder why we were all so blindly asleep as we were and why, much sooner than we did, we did not welcome and follow your teaching.
A final point Wiley made about chronic illness and our food supply also holds just as true now as it did then:
The deplorable condition of our young men was vividly shown in the Great War [World War 1]. Fully one-third of those called to the colors were found to be physically and mentally unfit to serve their country in its hour of need. Another third could only attend to camp and hospital tasks. Only one-third could go into the trenches and serve their country on the field of battle.
It was a matter of supreme importance to endeavor in all honorable ways to remove the possibility of a similar stigma which might arise from any future crises of the republic. To instruct young persons to be parents, to teach them how to bring up their children after they are born, and to eliminate such a percentage of unfit are problems which require careful study.
Note: RFK has repeatedly emphasized that our nation faces a grave national security risk as a recent Pentagon study found 77% of young Americans are ineligible to serve in the military due to their pre-existing health issues (e.g., obesity).
The Kefauver–Harris Amendment
In the years that followed Wiley’s departure, the handicapping of the FDA continued and it drifted towards specificity (making sure it did not act in error) rather than sensitivity (taking bad things off the market) until thalidomide completely flipped things in the other direction.
Discovered in 1952, thalidomide began being marketed in 1957 (initially over the counter) as a miracle cure for morning sickness, insomnia, colds, and headaches, and before long 14 pharmaceutical companies were selling it in 46 countries under at least 37 trade names. Reports soon emerged of infants born with partially missing limbs. In 1959, it was observed to cause peripheral neuritis. At the end of 1961, it was taken off the German market in November and then globally in December after an Australian doctor was finally able to get a letter published in the Lancet about it causing birth defects (after having unsuccessfully tried to sound the alarm since June of 1961).
Note: during its brief availability in Germany, thalidomide was estimated to have caused over 10,000 birth defects and the deaths of approximately 2,000 children.
Thalidomide’s adoption in America was slower since the initial American company its manufacturer approached found it lacked efficacy in their preliminary trials and hence didn’t want to market it. By the time a second company began testing it across America at the end of 1960, widespread concerns existed about thalidomide. This led the FDA reviewer assigned to thalidomide, Frances Oldham Kelsey, who was not allowed to block thalidomide from coming to market, to instead repeatedly stall its approval.
As a result, roughly 20,000 American women received it during the extended clinical trials (with many injuries being observed throughout that period by the FDA). Still, it was kept away from the general population (excluding doctors who gave it to their personal circle because the manufacturer had not told them it was still experimental). Kelsey’s actions in turn, resulted in only 17 American birth defects occurring (from the preliminary testing done across America) and earned her a presidential medal from John F. Kennedy on August 7, 1962.
Since the FDA had lacked sufficient authority to block toxic drugs from coming to market, the near miss with thalidomide got Congress to unanimously pass the 1962 Kefauver–Harris Amendment, a law that required drug manufacturers to prove their drugs were “safe and effective” before bringing them to market, and
While this law was necessary, it also was highly misguided as it allowed the Secretary of Health and Human Services to also block a drug if:
There is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.
The term 'substantial evidence' means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof."
All of this led to a few major problems.
First, Kelsey’s actions dramatically increased the prestige of the FDA, both emboldening the agency and simultaneously leading to many other jealous officials wishing to get the recognition she did for stopping the next thalidomide (which DMSO, discussed later in this article, conveniently fit the profile of).
Because of this, the pace of new drugs entering the market dramatically slowed, and ever since then, a consistent complaint of Congress has been the FDA blocking medical therapies the public needs. For example, in each Congressional hearing over the FDA stonewalling DMSO, the Senators and Congressmen always emphasized the importance of a proper balance between the FDA being able to block harmful drugs while approving good drugs, but stated the pendulum had swung too far towards specificity, as since the law had passed the number of new drugs entering the market had slowed to a standstill.
Secondly, it galvanized the FDA into rapidly establishing its authority and creating numerous divisions to “police” questionable drugs without the organization being structured to effectively or appropriately administer that authority (which led to perpetual mismanagement, chaos, and frequent abuse of that power). For example, James Goddard (the FDA commissioner from 1966-1968) believed the organization required police powers to keep the scientific community in line, and used a variety of chilling tactics to enact this precedent (e.g., conducting unannounced raids and defaming researchers in the national media). On the one hand, I can sympathize with this perspective because over the decades the FDA had lost so much of its “sensitivity” in keeping harmful drugs off the market, but at the same time, he swung the pendulum far too far, and left the FDA with such poor specificity that it began habitually engaging in unjustified enforcement actions that significantly harmed the American people (e.g., by keeping DMSO from the country).
Third, the law required efficacy to be a “well-controlled” trial. This became a massive problem as the FDA relentlessly chose to define “well-controlled” as a double-blind trial (to the point they clung to this specific argument in 1980 when Congress and the Senate grilled them over their decision to stonewall DMSO).
This was a huge issue because:
•I believe it enshrined the scientific supremacy of randomized controlled trials (RCTs).
•RCTs are extremely expensive. As such, most can only be done by the pharmaceutical industry, which due to their cost, consistently frames them (presented in favorable ways, ignoring or adjusting harmful data) to protect the company’s investment (which leads to RCTs frequently being highly inaccurate). This in turn, rapidly increased the cost of drug approval, effectively turning drug approval into a pay-to-play type situation (e.g., currently, the cost to bring a new drug to market is estimated to be between 0.98-4.54 billion dollars, which makes it impossible for any unpatentable product ever to get FDA approval).
•RCT fundamentalism is highly misguided as smaller observational unblinded trials will typically yield the same results as large (non-corrupt) RCTs (proven by this 2014 Cochrane Review), especially if the effect of a drug is significant (rather than a tiny one that can only be detected in a large controlled study and hence is likely inconsequential). This matters because most innovative therapies are developed by clinical observations that lead to those smaller trials, but due to RCT fundamentalism, all of that compelling research is inevitably thrown in the trash. For example, anytime someone uses an effective therapy that competes with the medical monopoly, if costly RCTs have not been performed, the establishment always cries “there’s no evidence” for the therapy. It uses this to justify stonewalling it and targeting anyone who provides it.
Finally, once these provisions became enacted and the FDA began targeting “unapproved” therapies, the number of remarkable medical innovations produced in America dramatically declined. This decline in turn, paralleled the overall decline in disruptive science, which swept America as scientists faced more and more pressure (e.g., from the grant system they depended upon) never to investigate unorthodox ideas that challenged existing paradigms. As such, in recent decades, we’ve had surprisingly few major discoveries that rewrite the rules of science despite the technology that could make those discoveries having significantly advanced.
What’s particularly sad about this is that many of the forgotten medical therapies I use in practice were developed between the 1920s to 1960s, as this was the time when technology had advanced enough to begin making “cutting edge” medical therapies, while the censorship apparatus had not yet evolved enough to keep them from seeing the light of day.
The FDA in the 1970s
Because the FDA had rapidly expanded in numerous directions it was not prepared to do, it frequently failed to fulfill its primary responsibilities (e.g., taking something harmful off the market), and it simultaneously took things away Americans actually wanted. This in turn led to numerous committees investigating the FDA (e.g., Commissioner Lay’s Kinslow report of his agency’s serious shortcomings) and key officials with integrity like Lay being kicked out, all of which were encapsulated a series of scathing articles that were published in the New York Times in 1977 (e.g., this, this, this and this one), which included passages such as:
But the agency, a bureaucratic waif that is responsible for overseeing a staggering $200 billion worth of products yearly, is not only whipsawed by the public controversy, it is so demoralized that a number of its top positions long go unfilled, so burdened that it cannot keep up with the explosion of consumer goods and so battered by lawsuits and outside pressures that its power to make its decisions stick is sometimes undermined.
Its bureaucratic problems have been so vexing that in just the last three years the agency has been the target of more than 100 Congressional investigations, 50 highly critical reports by the General Accounting Office and a series of internal inquiries despairing of ever setting the place right.
The Congressional hearings in the last couple of years just about destroyed the agency,” an agency official said privately. “The staff has been torn by dissension and strife, the morale is bad, there's no direction and stagnation has set in.”
Indeed, after his departure as Commissioner of the agency in 1969, Dr. Herbert E. Ley said that “what the F.D.A. is doing and what the public thinks it's doing are as different as night and day.” He complained further that during his 18‐month tenure he had been under “constant, tremendous, sometimes unmerciful pressure” from drug industry officials.
As problems arise the agency becomes embroiled in thousands of cases, some of which develop into national controversies, and at times it seems that the agency lurches from crisis to crisis.
A year ago the Ford Administration was on the verge of releasing an economic‐report containing scathing criticism of the agency's utility and effectiveness. The comments were later deleted for unexplained reasons.
Key administrative positions at the agency have sometimes gone unfilled for years and as a result various departments have been allowed to drift and founder through lack of leadership and authority.
Groups of dissident employees have trooped to Capitol Hill to testify against their superiors, plunging the agency into name‐calling internal squabbles that remain unresolved.
The internal complaints have also concerned lower level employees, with some agency officials privately describing members of the F.D.A.'s professional staff as “retreads” and “has beens.” In testimony a year ago dealing with low morale at the agency, Dr. J. Richard Crout, director of the Bureau of Drugs, said this about the chaos in which he had found the agency:
“There was an enormous documents room . . . where some people said fights went on and there was absenteeism. There was open drunkenness by several employees, which went on for months. There was intimidation internally. I tell you that in my first year at F.D.A., even lasting longer than that, 1972‐73, going to certain kinds of meetings was an extraordinarily peculiar kind of exercise.
“People—I'm talking about division directors and their staffs—would engage in a kind of behavior that invited insubordination. People tittering in corners, throwing spitballs—I'm describing physicians. People who would, let me say, slouch down in a chair, not respond to questions, moan and groan with sweeping gestures, a kind of behavior I have not seen in any other institution as a grown man.”
In summing up hearings of the two subcommittees, Senator Kennedy said last summer: “During the past two years these subcommittees have received testimony from 30 F.D.A. employees about the practices and internal management of the agency.
“These accounts included serious allegations of undue industry influence, improper transfers, details or removals, alteration of files and forced withdrawal of memoranda, bias toward drug approvals, improper manipulative use of advisory committees, disappearance of critical agency action memoranda into what the F.D.A. Commissioner termed ‘a mysterious bottomless pit,’ and incredibly slow moving ineffective enforcement and compliance programs with years elapsing between the discovery of a problem and the initiation of a solution, and inappropriate use of medical officer recommendations.”
Such disputes wear and divide further an agency that in recent years has been accused in lawsuits of incompetence or wrongdoing, has been investigated more than 100 times by Congressional panels and has had its intent challenged by liberals and conservatives. All the while, new products continue to be spewed out by the score, while the agency says it cannot monitor those already on the market.
The 766‐page report of the group, headed by Norman Dorsen, a professor at the New York University Law Center, cited detailed cases of harassment of staff by F.D.A. officials, insubordinate behavior by professional staff and inordinate delays in making recommendations on the quality of new drugs.
In my eyes, the most important thing about this period of FDA reforms was that the FDA was the most complained about agency in the government, and Congress made numerous attempts to fix it (and ethical FDA officials). Still, nonetheless, the situation described in the NY Times series persisted throughout the agency.
The DMSO Saga
Over the last three months, I’ve begun exploring a remarkable forgotten side of medicine—DMSO, a simple and freely available natural chemical that is one of the safest substances in existence and incredibly effective at treating a variety of conditions, including many which are otherwise impossible to treat.
In turn, once DMSO discovered in the early 1960s, it spread across the country like wildfire as patients immediately saw it treat a variety of debilitating conditions (e.g., chronic pain or severe arthritis), and researchers realized that it represented a new therapeutic principle that would completely transform medicine. Before long, the entire research community had gotten behind it, as they realized DMSO’s remarkable properties would completely transform the practice of medicine. Likewise, since opening up this topic, I’ve received over a thousand reports from readers who have had almost unbelievable results from DMSO that precisely match what many reported in the 1960s and 1970s.
For reference, those conditions included:
•Strokes, paralysis, a wide range of neurological disorders (e.g., Down Syndrome and dementia) and many circulatory disorders (e.g., Raynaud’s, varicose veins, hemorrhoids), which I discussed here.
•A wide range of tissue injuries such as sprains, concussions, burns, surgical incisions, spinal cord injuries (discussed here).
•Chronic pain (e.g., from a bad disc, bursitis, arthiritis or complex regional pain syndrome), which I discussed here.
•A wide range of autoimmune, protein and contractile disorders such as scleroderma, amyloidosis, and interstitial cystitis (discussed here).
•A variety of head conditions, such as tinnitus, vision loss, dental problems, and sinusitis (discussed here).
•A wide range of internal organ diseases such as pancreatitis, infertility, liver cirrhosis (discussed here).
•A wide range of cancers, infections, and skin conditions.
This all raises a simple question. How is it that no one knows about DMSO or that an agent which could dramatically reduce the need for opioids or prevent millions with stroke and spinal cord injury from having a life of disability never saw the light of day?
Quite simply, the FDA and the pharmaceutical industry were initially extremely interested in DMSO. However, once the FDA recognized the scale of new drug applications they would need to process, to get out of having to do that, they reversed their position and declared (without evidence) that DMSO was an extremely dangerous substance, and threatened both the pharmaceutical companies (who had already made significant investments to bring DMSO to market) and each researcher in the country who was giving it to patients in an unapproved manner.
Before long, the head of the FDA (Goddard) realized demonizing DMSO (a “dangerous” drug that was rapidly spreading across the country and being used by “irresponsible” researchers in an “unapproved” fashion) would give the FDA justification for the police powers he sought for the agency. In turn, due to both Goddard’s crusade and the FDA (like any other government agency) not wanting ever to admit they had been at fault, the agency continued to double down on the claim “DMSO was dangerous” even after an exhaustive safety study demonstrated that taking 10 times the typical DMSO dose for 90 days posed no risk to human participants.
Note: one journalist who interviewed multiple successive FDA commissioners and reviewed all the guidances the FDA put out about DMSO was struck by how little the FDA’s leadership understood about the most controversial drug in America and how misleading and inaccurate (and unreferenced) the FDA’s DMSO guidelines were.
Since many people relied upon DMSO to treat their chronic pain (along with a variety of other debilitating injuries), physicians, patients, politicians, and celebrities resisted this encroachment, and after years eventually forced a Congressional and then a Senate hearing. In these hearings, the FDA was confronted with a mountain of evidence (and numerous compelling patient stories) showing DMSO did indeed work (including for numerous terminal conditions which desperately needed treatment). Nonetheless, the FDA continually stuck to the claim there was “no evidence” DMSO worked, as blinded placebo controlled trials had never been conducted with DMSO—something which had never been done because of DMSO’s unique properties (e.g., the temporary skin irritation, characteristic odor and rapid dramatic improvement it frequently causes) made it impossible ever to conduct a truly blinded trial on it.
At both hearings, the FDA promised the legislators that any future drug applications for DMSO would be given a fair chance. However, this never happened, and the embargo persisted for decades as the FDA continued to escalate its war against natural medicine. This eventually cumulated in a completely unjustified 1992 raid on a famous integrative medicine clinic (which Dr. Wright describes below).
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