The FDA
by Hans Ruesch

People think the FDA is protecting them—it isn't. What the FDA is doing and what people think it's doing are as different as night and day.
Herbert L. Ley, Jr., M.D.,

former Commissioner of the FDA

The hearings have revealed police state tactics... possibly perjured testimony to gain a conviction... intimidation and gross disregard for Constitutional Rights.
Senator Edward Long,
U.S. Senate hearings on the FDA

The cancer conspiracy is led by the FDA-NCI-AMA-ACS hierarchy.

 

The initials stand for the Food and Drug Administration (FDA), the National Cancer Institute (NCI), the American Medical Association (AMA), and the American Cancer Society (ACS).

 

The cancer conspiracy also includes the large pharmaceutical companies and key research centers such as the Memorial Sloan-Kettering Cancer Center in New York City and selected university research labs.

 

The key personnel move in and out of official positions within these organizations, sit on common boards or investigation committees, and have both formal and informal networks. When a researcher or alternative medicine advocate is identified as a threat to the power or even the official views put out by the ruling hierarchy, the maverick is placed on various published and unpublished blacklists, Funding is stopped, legal harassment often begins, public denunciation as a quack frequently follows, and if the outsider persists in offering or advocating a non-sanctioned treatment, then rougher, clandestine methods can be employed.

It would take thousands of pages to describe various individuals who have fought the cancer conspiracy and how their threat to the ruling powers was neutralized. These pages can only summarize some of the more famous cases and facts which reveal how the cancer conspiracy functions, but those who wish to know more can pursue the details on their own, using the names and references offered here as a starting point. The people and procedures described in these pages are by no means inclusive, only the most notable or most promising.

The FDA (Food and Drug Administration) is the government police force which approves experimental studies for those it favors and hinders approval for those it dislikes. It conducts semi-legal break-ins (constitutional procedures are often ignored), confiscates records so that critical documentation is often lost or at least unavailable for months or years, and at times has interfered with constitutional protections through conspiratorial relationships with private organizations who share the same suppressive goals.

 

New medical breakthroughs that threaten the sanctioned and financially lucrative treatments are ignored or "studied" for years. The FDA thus frequently subverts its legislated purpose which is to promote and protect the public health. Having lived in Washington, D.C., I know that the FDA is regarded by many astute civil servants as the federal agency with the lowest morale. A dark cloud of oppressive inertia, corruption and bureaucratic sloth pervades its corridors.

Dr. J. Richard Crout, test director at the FDA Bureau of Drugs beginning in 1971, described the agency in Congressional testimony on April 19, 1976 as follows:

There was open drunkenness by several employees which went on for months... crippled by what some people called the worst personnel in government. Here was intimidation internally by people.... People, I'm talking about division directors and their staff, would engage in a kind of behavior that invited insubordination—people tittering in corners, throwing spitballs, I am describing physicians, people who would... 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.... Prior to 1974, not one scientific officer in our place knew his work assignments, nor did any manager know the work assignment of the people under him.

In 1967, the FDA stopped the use of an experimental cancer vaccine which was producing significant results. It was developed by H. James Rand, inventor of the heart defibrillator. J. Ernest Ayre, an internationally recognized cancer specialist (co-developer of the PAP test) and Dr. Norbert Czajkowski of Detroit, Michigan assisted Rand.

 

Treating only terminal cancer patients, the Rand vaccine produced objective improvement in 35 percent of 600 patients while another 30 percent demonstrated subjective improvement.

"One 65-year-old woman with spreading tumor" was "completely cured in four months."

Another woman with extensive breast cancer was cured in six months. The FDA stopped the vaccine's use in a federal court hearing where neither the cancer patients nor their doctors were allowed to testify. U.S. Senator Stephen Young of Ohio protested—to no avail. Senator Young could get nowhere with FDA Commissioner James L. Goddard.

 

Senator Young recalled:

I could not move them. They would not even agree to a modification of the ruling (banning the Rand vaccine), which would at least allow the 100 (cancer) patients at Richmond Heights (Ohio) to complete their injections. The Justice Department was prepared to go along, but the FDA Commissioner, Dr. James Goddard, was adamant, even belligerent. It's wrong of the government to snatch away this hope when there is no evidence against its use offered in court. It's damnably wrong.

It is known that when FDA Commissioner Goddard's own wife had serious health problems and orthodox medicine could not help her, Goddard contacted alternative health practitioners who quietly healed his wife. But for the suffering victims of cancer who needed the Rand vaccine or some other nontraditional treatment, Goddard lowered the boom, using the federal courts to enforce his dictum.

 

Such are the ways of the FDA.

Goddard's greatest disservice to the American people was his persecution of DMSO (dimethyl sulfoxide), a simple molecule which often brought miraculous pain relief and offered numerous possibilities for medical advancement in other areas, including cancer.

 

One respected science writer suggested that Goddard crushed DMSO research in order to gain increased police powers from Congress.

 

The FDA has never admitted its errors regarding DMSO although the positive studies from qualified scientists number over a thousand while the FDA's criticisms have been shown to be almost completely based on lies or unsubstantiated rumors. Yet by the late 1980s, twenty years later, the FDA continues to imprison DMSO advocates.

 

The malignity of Goddard's arbitrary and conscienceless acts in 1966-1968 against reputable scientists, dedicated doctors and the public good is one of the darkest chapters of FDA history.

No one is sure of the real reasons why it happened and why it continues to be covered up twenty years later. It has been suggested that one or more drag companies sabotaged DMSO because it threatened so many of their profitable products.

 

One drag company executive reportedly told the leading DMSO researcher:

I don't care if it is the major drug of our century—and we all know it is— it isn't worth it to us.

Who had the power to keep such a miraculous drug off the shelves? Surely not just an FDA Commissioner flexing his muscle. Was it a combination of drag companies whose individual profits were threatened by the miracle drag's possibilities?

[It is] not our [FDA] policy to jeopardize the financial interests of the pharmaceutical companies.

—from testimony before Congress of Dr. Charles C. Edwards, at the time commissioner of the FDA

It has also been surmised that FDA Commissioner Goddard used DMSO in 1966 in an attempt to become the medical dictator of America. In the years that followed, FDA officials simply refused to expose the agency's "dirty laundry." Hence the on-going suppression of what many recognize as "the major drag of the century."

 

In any case, Goddard instilled fear into honest researchers and physicians as no previous FDA Commissioner had done. He rained careers. He introduced an intensified police force mentality into the FDA with his emphasis on hiring ex T-men and G-men. He consciously blacklisted scientists as punishment for opposing him. And members of his agency, either with his encouragement or his acquiescence, openly began ignoring the Constitution for the sake of promotions and power.

Pat McGrady, Sr.'s book, The Persecuted Drug - The Story of DMSO, detailed what Goddard's FDA did.

 

McGrady described,

"the no-knock system, the photocopying of private papers, bugging, punitive investigations, slander and libel, character assassination, forgery, lying and blackmail."

One scientist declared to McGrady:

For the first time in my life I know fear. I'm afraid for my family and myself. I'm afraid for doctors and scientists. And I'm more afraid for our country. I can't believe these things are happening in the United States.

Another noted researcher maligned by Goddard's FDA observed:

The academic community and industry are so completely intimidated that one cannot look for any leadership to counteract some of the punitive actions of the FDA.... I am very pessimistic concerning the future status of medical research unless a mood arises to combat overzealous bureaucratic authority.

Dr. Walter Modell of Cornell University Medical College finally warned in a published article ("FDA Censorship" in Clinical Pharmacology and Therapeutics):

When the non-expert in-group of the FDA threatens to become the dictator of American medicine we believe it will lead medicine from its respected eminence to its ultimate decline.

A few years after the DMSO suppression, one of Goddard's top aides, Billy Goodrich, left the FDA with his pension and became president of a food association regulated by the FDA. A personal friend who had been president of the food association took over Billy Goodrich's position at the FDA. They simply switched jobs! Congressmen screamed in protest. It was such a blatant demonstration of the "musical shuffle" (which Congress had previously observed but ignored) that they had to make some noise this time in order to avert public wrath. Still after all the sound and fury, nothing happened.

Goddard himself became Chairman of the Board of Ormont Drug and Chemical Company a few years after leaving the FDA.

A study conducted by the U.S. Congress in 1969 revealed that 37 of 49 top officials of the FDA who left the agency moved into high corporate positions with the large companies they had regulated. A General Accounting Office (GAO) study of the FDA in 1975 revealed that 150 FDA officials owned stock in the companies they were supposed to regulate. The record of "conflict of interest" (or worse) within the FDA is deep and extensive.

In 1976, Dr. J. Richard Crout of the FDA admitted that "endless questions" was a favored technique within the agency to discourage any researcher who sought approval for an unorthodox cancer therapy. Bureaucratic obstruction is a weapon as deadly as a gun when the lives of innocent millions are at stake. It is a delusion to consider such institutionalized, orchestrated conduct, consciously chosen either because of orders from above or personal inclination, as anything other than white collar murder. In fact, it closely resembles the role carried out by the bureaucrats who pushed the paper in Nazi Germany. The policy-makers may not fully perceive the effect of their actions, but the horror has gone on for too many decades to allow a plea of ignorance to be totally convincing.

In 1972, Dean Burk, Ph.D., of the National Cancer Institute (head of their cytochemistry section and a veteran of thirty-two years at the agency) declared in a letter to a member of Congress that high official of the FDA, AMA, ACS and the U.S. Department of Health, Education and Welfare (now Health and Human Services or HHS) were deliberately falsifying information, literally lying, committing unconstitutional acts and in other ways thwarting potential cancer cures to which they were opposed.

Dr. Burk's famous May 30, 1972 letter to Congressman Louis Frey, Jr. dealt with the issue of why the FDA had revoked an Investigative New Drug (IND) application. The IND application, according to Dr. Burk, was superior to many routinely approved. But it involved testing laetrile, a controversial, non-patentable product opposed by the California Medical Association (CMA). FDA approved the original application, then rescinded the license, apparently because of pressure from the surgeon general, a member of the CMA and a laetrile foe.

Dr. Burk was not an advocate of laetrile. He was, however, in favor of fair testing. He was totally opposed to what he bluntly called "misleading and indeed fraudulent" FDA reports. In his correspondence with Congress, he openly referred to "FDA corruption."

Corruption indeed. It takes several forms. Refusing to allow investigation of a non-toxic compound which might help cancer patients is one. Failing to assert itself when a drug tested on human beings was deter-mined to cause cancer is another. Here are the facts of such a case:

In August 1969 it was learned that a drug called Cinanserin, produced by E. R. Squibb and Sons, Princeton, New Jersey, caused tumors in the livers of rats. Human testing of the drug was thus stopped. But Squibb's executives did not want to do follow-ups on the humans who had taken Cinanserim.

For three years, the FDA tried to persuade Squibb to do follow-up studies. (Compare this approach with what the FDA does to alternative cancer treatments which actually work—raids, confiscation of documents, jail, etc. With the large drug companies, FDA tries persuasion!)

Finally, in 1972, the FDA and the National Academy of Sciences set up a committee to examine procedures on follow-ups when a drug was found to be dangerous. Who was appointed to head the committee? The vice-president of Squibb whom the FDA had tried for three years to persuade to do follow-ups on those people who had been given the cancer-causing drug!

The FDA has a long history of ignoring dangerous drugs and chemical additives marketed by the big drug companies while using bureaucratic delays, legal harassment, unconstitutional procedures, and even falsified evidence to stop unorthodox cancer treatments. In 1964, the FDA initiated a multimillion dollar prosecution of Andrew Ivy, vice-president and professor of physiology at the University of Illinois. Ivy was former chair-man of the National Cancer Institute's National Advisory Council on Cancer. He was an internationally recognized scholar and a prolific author of scientific papers.

His sin was that he supported a cancer-curing serum called Krebiozen. Over 20,000 cancer patients had supposedly benefited from Krebiozen. One United States Senate Committee lawyer personally assessed 530 cases and concluded that Krebiozen was effective.

Krebiozen has never been tested objectively. The FDA used illegal methods to stop it, methods which have been part of a conscious goal of the FDA to dictate what medicine a citizen is permitted to use and what he may not use. Combined with the questionable behavior of FDA officials, the stock links to the large drug companies, and the testimony of FDA employees that conscious cover-ups were common, the intention of the FDA to dictate individual medicine has to be recognized as one of the most dangerous threats to freedom that has ever existed.

Peter Temin, a professor at MIT, carefully studied FDA history and policy for his 1980 book, Taking Your Medicine: Drug Regulation in the United States.

 

His conclusion, based on a very careful, close look at FDA is frightening:

The most important facet of FDA regulation is the agency's expression of its conviction that individuals—both doctors and consumers—cannot make reasonable choices among drugs. The agency tried with increasing success to deny drug prescribers and users the option of taking "innocuous" drugs, that is, to force them to use drugs the FDA regards as appropriate for their condition.

Despite evidence which extends for decades, revealing criminal behavior in the one agency that holds the power to permit tests of alternative cures for cancer, Congress has done nothing. One night in Washington, D.C., I found out why. I was introduced to the aide of one of the most powerful U.S. Representatives in Congress. His boss had been in Washington for many years. Yet, despite the Congressman's powerful committee position and ranking status in the majority party, he was unable to do anything with the health officials at FDA or NCI.

 

After a number of drinks, this Congressman's aide told me that FDA and NCI were protected fiefdoms. They wrote their own legislation, permitting only minor changes by Congress. They ignored Congressional complaints.

 

They were extensively tied to the big drug companies.

"They know no one controls them. No one is able to take a sword and tell them where to go," the aide said. He leaned across the table and whispered, "Only national security procedures are as tightly controlled, without outside examination. Only national security. Does that tell you something?"

It told me that the monster was real and dangerous if some of the most powerful men in the U.S. Congress, with their massive egos and independent political bases, were afraid of it.

G. E. Griffin, author of World Without Cancer, made explicit the fundamental, systematic wrong which has emerged out of the various cross-currents that make up the FDA—underpaid civil servants playing it safe; drug companies and their Washington lawyers putting unending pressure on the bureaucrats; academic medicos controlling the approval process and restricting the individual doctor's choice; revolving door employment between FDA and universities/drug companies, and behind-the-scenes political deals.

 

According to Griffin, the FDA did two things:

  1. they "protected" the big drug companies and were subsequently rewarded

  2. they attacked—using the government's police powers—those who threatened the big drug companies, be it a young company with a new product such as DMSO, or natural health store products such as food, vitamins, minerals or other self-healing (non-drug, non-doctor) methods.

Griffin wrote the following about the FDA:

  1. First, it is providing a means whereby key individuals on its payroll are able to obtain both power and wealth through granting special favors to certain politically influential groups that are subject to its regulation. This activity is similar to the "protection racket" of organized crime: for a price, one can induce FDA administrators to provide "protection" from the FDA itself.
     

  2. Secondly, as a result of this political favoritism, the FDA has become a primary factor in that formula whereby cartel-oriented companies in the food and drug industry are able to use the police powers of government to harass or destroy their free-market competitors.
     

  3. And thirdly, the FDA occasionally does some genuine public good with whatever energies it has left over after serving the vested political and commercial interest of its first two activities.

There is only one solution. No reform will work. No changing of personnel will have any long term effect. No new laws dealing with regulations. Only one solution.

It was provided by a southern doctor now living in New York City who has observed the monster in action for many years. Raymond Keith Brown, M.D., outlined the solution in his book, Cancer, AIDS and the Medical Establishment. He described how the power which FDA has to approve drugs and technology has to be eliminated and replaced with the solitary role of testing for effectiveness and safety, the results being the basis for FDA labeling. The individual physician and individual patient would regain the responsibility to use or not use a given-drug or technology.

Dr. Brown recommended that,

The FDA should follow a simple rating system for effectiveness and safety. Effectiveness would fall into one of three categories:

  1. "Effectiveness Unconditionally Proved"

  2. "Effectiveness Conditionally Demonstrated"

  3. "Effectiveness Undetermined"

Safety could also be categorized in the same manner and the appropriate designation then affixed to all products or containers. Judgment of the effectiveness of any medical product or device should not be vested in any governmental agency or institutions, but should be returned to the province of the individual physician. Freedom of choice for medical materials, therapy and methods must be put on the same footing as civil liberties and as vigorously protected.

One of the better scholars in this field—Robert G. Houston—says simply:

There should be curbs on the FDA—on its powers to intrude into the private practice of medicine ... the FDA should not be dictating to doctors what they can and cannot do.

Richard Ericson, a dedicated husband of a cancer victim, eloquently concurred (Cancer Treatment: Why So Many Failures?):

A physician should be able to prescribe any type of cancer treatment that he considers best for the patient, with the patient's consent and knowledge, without stringent governmental regulations that are now in force. Congress should consider such problems when new guidelines are enacted.

 

Only when FDA concentrates on the blatant health menaces such as overtly misleading health product claims or drugs shown to cause death and injury; only when FDA ceases to be the bully boy for the big drug companies and other vested interests; and only when FDA again allows physicians, nonconventional healers and their patients their choice of therapeutic treatments ... will it regain its legitimate government function.

 

In its present form, it is like a malignant beast, harming society rather than serving it.


AMERICAN CLINICAL LABORATORY CITES TOWNSEND LETTER
Excerpts (August 1992)

According to reports in the Townsend Letter for Doctors (#108, July 1992, p. 559) including the reprint of an editorial from the Seattle Post-Intelligencer (P-I), U.S. Food and Drug Agency (FDA) agents wearing flak jackets and accompanied by a contingent of King County (Washington) police with guns drawn broke into the Tahoma Clinic (Kent, The Washington) at 9 A.M. on May 6th without knocking on the door or accepting an offer to have it unlocked. Commanded to "freeze!" and put their hands in the air, the employees of the clinic were escorted from the building and refused re-admittance for 14 hours while an uncounted number of boxes of clinic records and equipment was taken to an unknown location.

The clinic is owned by Jonathan V. Wright, M.D. (Harvard University; University of Michigan Medical School), who has practiced medicine in Washington since 1970 and treated tens of thousands of patients, including 1,200 currently under his care. The warrant issued authorized the search and seizure of injectable materials, including vitamins; a vice; literature; and patient records. Also raided at the same time was the For Your Health pharmacy operated by Raymond Suen. As of mid-July, no charges had been filed against anyone.

Suen, together with Kent Littleton, Chief Chemist, Meridian Valley Clinical Laboratory (Kent, Washington), had collaborated with Wright to submit a well-documented article, "Testing for vitamin K: An osteoporosis risk factor." (Am. Clin. Lab. 8[2], 16 [1989]). Wright et al. traced the connection between vitamin K and bone formation in promoting the gamma carboxylation of glutamic acid in osteocalcin that binds calcium ions leading to bone calcification. (In its identical but much better known function in blood clotting, vitamin K promotes the binding of calcium toprothrombin in its transformation to thrombin.)

 

While considerable vitamin K is presumably synthesized by normal intestinal flora, many clinicians are aware that normal micro-flora are much less frequent today than in the preantibiotic days.

 

Care must be taken in sample preparation and in the frequently used HPLC analysis of vitamin K in serum, but Wright finds that appropriate dietary changes and supplementation almost always result in substantial improvement in serum levels in just a few weeks.

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