FDA World: 1965-2008 -
A tiny peek into the mind of the FDA

I know I said this ended in 2008 but I couldn't resist reporting on just one more FDA announcement below. While many others have come out between 2008 and 2014, this one simply couldn't be ignored.

2014

Scientists and statistics have already proven that cholesterol medications like statin drugs, while lowering cholesterol, have not been shown to reduce heart attacks or strokes or prolong life. Pharmaceutical companies are now developing a new class of cholesterol-lowering drugs called PCSK9 inhibitors. It was thought that the FDA would make the drug companies prove that these drugs actually provided some health benefits. The FDA recently announced that it will approve these drugs based on their ability to lower LDL, not on whether they can decrease heart attack or stroke. Wall Street is waiting with baited breath for this new drug that, when approved, will generate billions in annual sales.

Result: The FDA has made it clear where their loyalty lies. They don't even try to hide it anymore. Once again, the public is left at risk.

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Listed here is a summary of some of the actions and judicial records of court outcomes involving the Food & Drug Administration (FDA) from 1965 to 2008. This is not an all-inclusive list as that would take volumes.

2008

In response to a barrage of criticisms, FDA commissioner Dr. Edward von Eschenbach requested a special committee to assess if the FDA is capable of doing its job. The 60-page report that came back, called "FDA Science and Mission at Risk" was an emphatic NO. Basically it stated that the scientific world has undergone revolutionary change but the FDA's "evaluation methods have remained largely unchanged over the last half century."

Result: The FDA's admission that it cannot do its job ignited outrage from organizations who have long argued that the FDA is the greatest impediment to the advancement of medical science.

2008

Despite intense lobbying by pharmaceutical companies, the FDA could not rationally continue to block the sale of tryptophan as it had done since 1989. Tryptophan is the only substance to safely increase serotonin levels in the brain. Serotonin is the natural compound that promotes wellbeing, satiety, and relaxation. A deficiency can result in sleep disturbance, anxiety, depression, and overeating.

Result: Americans are once again able to treat their serotonin deficiency disorder with this simple amino acid.

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2007

An FDA medical officer revealed that the staff of the FDA's Office of Drug Safety recommended initiating measures similar to Great Britain to reduce acetaminophen toxicity; namely, limiting the number of pills in a package and packing the pills individually in foil packs.

Result: The recommendation never reached the FDA's Nonprescription Drugs Advisory Committee, where it could have been considered and approved. The American public was left at risk by the very organization sworn to protect them.

2007

Senator Charles Grassley from Indiana investigated the FDA for inadequate labeling of the diabetes drug Avandia. The FDA safety staff recommended a black box warning indicating that the drug might put some patients at increased risk of congestive heart failure but the FDA ignored the recommendation.

Result: Americans were left at risk.

2007

Due to the outstanding results of European preliminary dimethyl sulfoxide (DMSO) trials conducted by American Dr. Stanley Jacob on traumatic brain injury patients, the FDA gave his new drug application "fast track" designation and phase 2b trials began. (See 1965 - 1982)

Result: After halting all scientific studies on DMSO in 1965, and after 50 years of research since this versatile substance was discovered in 1960, and more than 10,000 scientific articles on its biological implications, and untold deaths and suffering that could have been prevented or alleviated if this information was allowed to be made public, this is the equivalent of too little too late.

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2006

The FDA took steps to suppress information about foods that reduce disease by issuing an edict that precludes cherry companies from posting scientific data on their websites, saying that when cherry companies disseminate this information, the cherries become unapproved drugs subject to seizure and, if it continued, criminal prosecutions would ensue.

Result: Consumers are denied access to information that could be used to make wiser food choices. Note: The scientific data showed that cherries were more effective than some FDA-approved drugs in alleviating arthritis inflammation and pain.

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2005

Rep. Edward J. Markey of Maine released a report on June 1, Conspiracy of Silence: How the FDA Allows Drug Companies to Abuse the Accelerated Approval Process, revealing that at least 17 drug companies did not complete the FDA required post-marketing studies. Of 42 pending studies, half have not even been initiated.

Result: Although the FDA has the authority to remove drugs from the market in the absence of supporting data, it has not done so in any cases.

2005

After a two year investigation, the book Dangerous Doses: How Counterfeiters Are Contaminating America's Drug Supply makes it's debut. Katherine Eban, investigative medical reporter, follows Florida criminal investigators as they exposes a sprawling national network of drug polluters that operates freely under the nose of the FDA. Even though the FDA has an Office of Criminal Investigations with the authority to prosecute counterfeiters aggressively, the agency does not usually pursue these matters and did nothing to bring these criminals to justice.

Result: America discovers that the high-price drugs we purchase in the US may actually be more dangerous than the less expensive Canadian and European drugs the FDA says we should not obtain.

2005

Dr. David Graham, associate director for the Office of Drug Safety and a 24 year FDA veteran, completed a three-year study on the pain drug Vioxx and testified before the US Senate Finance Committee that the approval and continued use of Vioxx was the equivalent of two to four deadly airplane crashes a week for five years. He described the explosive response he got from his superiors when he submitted his study conclusions for internal review by the FDA; which through harassment, intimidation, and attacks on his integrity, caused a two month delay in alerting the public.

Result: Before it was removed from the market, Vioxx was implicated in about 160,000 cases of heart attack and stroke in the US between 1999 and 2004 -- the equivalent of 100,000 unnecessary deaths.

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Quote: "the tradition at the FDA has been to react negatively to new information that illustrates how the FDA's policies are inadequate or wrong," Dr. Graham said. "When you illustrate that the FDA's policies are harmful, the reaction is negative and immediate." (He was referring to the fact that Vioxx was not an isolated case. The fact that it was made public was the exception rather than the norm.)

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Dr. Graham identified several other drugs that demanded immediate action:

• Meridia, used for weight loss - associated with high blood pressure and stroke.
• Crestor, used to lower cholesterol - linked to renal failure and other serious side effects.
• Accutane, used to treat acne - associated with birth defects.
• Serevent, used to treat asthma - can actually aggravate and cause death due to asthma

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Quote: "You want to be evidence based, but the FDA would rather suspend its judgment so it can better serve its clients... industry," said Dr. Graham. (He was referring to the fact that the FDA accepts money from the very industry its supposed to regulate.)

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2004

Dr. Mosholder conducted a meta-analysis of 22 studies showing a link between suicide and the use of antidepressants like Prozac and Zoloft in children, concluding that children on these medications were twice as likely to become suicidal. Senior FDA officials intervened before he could make his results public. He was told to alter his research findings in material that was submitted to Congress. He was threatened with disciplinary action if he went to the media. He was barred from testifying at a public hearing on antidepressants and children.

Result: A previously unpublished FDA internal management review was released in which 846 FDA scientists were asked to complete an extensive survey to which about half responded. The survey found that nearly 20% said they "have been pressured to approve or recommend approval (for a drug) despite reservations about the safety, efficacy, or quality of the drug."

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2004

A coalition of pharmacies from TX, AZ, AL, WS, CA and CO filed suit against the FDA claiming that it illegally enforces an arbitrary regulation out of its jurisdiction and conducts unlawful inspections, illegal interventions, and intimidation of law-abiding pharmacies. The issue was the centuries-old practice of compounding medications tailored to an individual patient's needs.   Note:   compounding protection laws were enacted in 1962 to ensure the best healthcare for patients and pets.

Result: Even though the FDA has no legal authority over pharmacies, they issued a compliance policy guideline that made the use of bulk ingredients in the preparation of medications illegal. They have since waged an aggressive inspection campaign to enforce the guideline.

2004

The FDA allows the following health claim on products containing the omega-3 fatty acids eiscosopentaenoic acid (EPA) and docosahexaenoic acid (DHA):

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Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.

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2004

FDA succumbs to pressure from family members of Alzheimer's patients and approved the sale of Namenda in the US... sold in Germany since 1990 under the name Memantine. Memantine blocks the excitotoxicity reaction, a pathological process where too much glutamate is released in the brain, severely damaging the neurons.

Result: That it took litigation, harsh media criticism, and a citizens' uprising to motivate the FDA to approve these drugs is a testament to the agency's inability to differentiate between safe, effective medications that should be approved and lethal drugs that should be removed.

2004

January 22, the FDA confirmed that acetaminophen (contained in 600 drug products) is extremely dangerous.  This was after ignoring their own scientific advisory committee's advice in 2002 that warnings be put on labels of acetaminophen drugs.   They also ignored research presented to them in 1992 showing that many more people are dying of acetaminophen than official statistics indicate and that regular users of acetaminophen may be doubling their risk of kidney cancer.

Result: The incidence of kidney cancer in the US rose 126% between 1960 and 2004, a jump that may be tied to the growing use of drugs containing phenacetin or acetaminophen. Phenacetin was a painkiller, banned because it caused severe kidney toxicity. Acetaminophen is the major metabolite of phenacetin. If even a fraction of the almost 12,000 annual deaths from kidney cancer could have been prevented from proper labeling, this huge denial on the part of the FDA may have resulted in tens of thousands of American deaths.

2004

Dr. Julian Whitaker filed a petition against the FDA that meticulously documented the many lethal effects of statin drugs when not accompanied by CoQ10. He wanted the following black box warning to be included on the package inserts:

Warning: HMG CoA reductase inhibitors (statin drugs) block the endogenous biosynthesis of an essential cofactor, coenzyme Q10, required for energy production. A deficiency of coenzyme Q10 is associated with impairment of myocardial function, with liver dysfunction and with myopathies (including cardiomyopathy and congestive heart failure). All patients taking HMG CoA reductase inhibitors should therefore be advised to take 100 to 200 mg per day of supplemental coenzyme Q10.

Result: Even though the underlying science presented was irrefutable, the FDA did not adopt the necessary language that could have saved countless lives and untold suffering if people only knew that this simple inexpensive supplement should be taken with the drug.

Note: Could there have been some bias involved since from 1985 - 1994 the FDA seized CoQ10 supplements and made a concerted effort to completely outlaw it stating that, since it was a prescription drug in Japan, it should not be freely available to Americans? This suggests that the FDA knew long ago of the power of this supplement.

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2003

Life Extension Foundation and Wellness Lifestyles, Inc. filed a health claim petition against the FDA to reconsider its permitted health claim for omega-3 fatty acids and coronary heart disease risk and to allow the following revised claim: "Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease." Also included in the petition was a calculation of how many American lives were needlessly being lost because of FDA restriction of this simple health claim.

Result: During the seven years it took to litigate this case, at great expense to the American public, it was estimated that Americans suffered over 1 million preventable sudden-death heart attacks.

2003

On November 17, PBS investigative series Frontline aired an hour long exposé on FDA complicity in allowing dangerous prescription drugs on the market with emphasis on the FDA's reliance on drug company flawed and altered research of their own products to determine safety. The most appalling disclosures were made by the FDA drug reviewers themselves who revealed incidences where clear dangers were ignored or covered up by higher-level FDA officials. Only after many injuries and deaths were these drugs withdrawn or relabeled.

Result: For the first time, the public is made painfully aware that a powerful regulatory body is not only at odds with its prime directive, the safety of the American public, but also has deliberately attempted to restrict consumer access to much safer method of healing using dietary supplements.

2003

The Washington Legal Foundation sued the FDA and the Department of Health and Human Services for "Better Access to Developmental Drugs" contending that the FDA's torturous drug approval process effectively denies terminally ill cancer patients access to experimental anti-cancer drugs, thereby violating their constitutional rights.

Result: Later the FDA would develop a "compassionate use" clause to make experimental drugs available to advanced cancer patients.

2003

FDA allows Phase I studies of Phenoxodiol, a drug that alters the signal pathway in cancerous cells to prevent them from undergoing programmed cell death or apoptosis. However, the FDA mandated that only low doses be used and only on advanced cancer patients that had failed to respond to proven therapies.

Result: Five Phase I trials had to be completed even though more than half of the patients tested showed some response with little or no side-effects. Therapeutic doses are not allowed until Phase II. Many years were wasted as advanced cancer patients died waiting for the drug to be approved.

2003

FDA allows the research firm, Geron Corporation, to enter into a Phase I study for a cancer vaccine that preliminarily showed a powerful effect against prostate, kidney, breast, melanoma and bladder cancer by boosting the immune system. However the FDA restricts the study to patients that fail all "proven" therapies first.

Result: It took a much longer time for Taxotere to gain FDA approval because it is very difficult to kill cancer cells once they become resistant to chemotherapy and the dosages allowed in Phase I trials are extremely low.

2003

The FDA supported an Oklahoma action against a pharmacy obtaining Canadian Drugs for US customers.

2003

After 20 years of denying the scientific research regarding the value of selenium in reducing certain cancers, and prosecuting anyone who dared to suggest it, the FDA finally capitulates and allows the labeling with a disclaimer, "The FDA has determined that this evidence is limited and not conclusive."

Result: The FDA continues with its extraordinary efforts to censor information about proper diet and supplementation.

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2002

FDA lost another court case, Whitaker vs. Thompson, over objection to the statement, "Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers." Judge Kessler ruled that these censoring actions were in violation of the Constitution's free speech clause.

Result: FDA continued to ignore court rulings regarding the First Amendment and denied manufacturers the right to state on the label the benefits of saw palmetto in reducing the symptoms of mild benign prostatic hypertrophy. They refused to review the claim, stating that it was a "treatment claim, hence was not covered under the provisions for health claims."

2002

FDA acquiesced to judicial pressure and created the "Better Health Information for Consumers" initiative, a policy that allowed for greater latitude when disseminating information about health foods and nutritional supplements.

Result: This later proved to be a public relations stunt.

2002

Despite lobbying efforts by the pharmaceutical industry, the Senate passed a bill to allow licensed pharmacists and drug wholesalers to import drugs that have been approved by the FDA from Canada. The bill was blocked in the House.

2002

The Supreme Court invalidated a provision of the FDA laws that banned pharmacies from advertising the availability of "compounded" pharmaceuticals, declaring that "regulating speech must be a last, not first, resort."

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2001

In an effort to protect the profits of the pharmaceutical industry, the FDA asked Congress to ban almost all drugs imported to consumers from other countries stating that "they may be counterfeit or worse." They wanted to waive the current requirement that Customs must contact recipients if it detains drugs at the border to give US citizens who paid for the drug notice and the opportunity to explain why they need them.

Result: The FDA still preys on fear while Americans are extorted into paying the highest prices in the world for prescription drugs. (See 1994 foreign drug Glucophage approval below)

2001

FDA suffers another scandal May 19 when The Lancet accused the FDA of receiving hundreds of millions of dollars in funding from the pharmaceutical industry over the drug Lotronex, approved in February 2000 but never approved by the European Evaluation Agency.   The devastating editorial revealed that although Glaxo-Smith Kline voluntarily withdrew the drug from the US market after five patients died, senior FDA officials were seeking to reintroduce it.   Reported were 49 cases of ischaemic colitis and 21 cases of severe constipation, including instances of obstructed and ruptured bowel.   Thirty-four patients had required admission to a hospital and 10 needed surgery.  Even though clinical data as early as July 2000 confirmed "substantial and potentially life-threatening risks," the FDA ignored the recommendation of its own scientists to advise people to stop taking the drug.

Result: The FDA still ignores the recommendations of its own scientists and often censures employees who disagree with the political decisions of the FDA to approve dangerous drugs.

2001

FDA lost a second time in "Pearson v Shalala" suffering court chastisement for acting with "less than reasonable speed" and consistently failing to comply with constitutional guidelines outlined by the courts.   Further, Judge Kessler stated that the FDA "must shoulder a heavy burden if it seeks to totally ban a particular health claim.   She also found the FDA's decision, "arbitrary, capricious and an abuse of discretion. "She explained that the continued violation of First Amendment rights constituted "irreparable harm" to the plaintiffs and that it "harmed the public interest."

Result: The court also held the FDA's interpretation of its health claims review standard unconstitutional and ordered the FDA to allow the four claims (see 1999 case) even if they failed to satisfy that standard. Today the FDA is still suppressing health claims in relation to other supplements.

2001

FDA fails to comply with its own food inspection program announced in 1997. The agency vowed to cut the 114,000 annual cases of seafood poisonings in half.   The total number of inspections dropped from 21,000 in 1981 to 5000 by 1996, a reduction of 76% citing budgetary constraints.   Yet they squandered millions of dollars a year in litigation expenses in futile attempts to suppress the free flow of information to the consumer, suffering one defeat after another in Federal Court.

Result: FDA reform is called for but not delivered.

2001

FDA suffers defeat when a Federal appellate court judge upheld a lower court ruling that, based on First Amendment rights, the FDA cannot restrict advertising by pharmacists who sell compounding drugs.

Result: A victory for freedom of speech that the FDA would later find a way to ignore. They found themselves in court again and again over this same issue as there is a direct competitive link to their "clients."

2001

FDA scandal attracts media attention when its discovered that over 50% of the FDA's expert committee members have financial ties to the pharmaceutical industry despite regulations that protect the American public from just such bias. The FDA granted 803 waivers over a two-year period (1998 - 1999) to skirt the regulations. Reports indicated that there were 146 out of 159 financial conflicts of interest in FDA advisory meetings during that same two-year period.

Result: To prevent additional publicity, the FDA stopped revealing financial conflicts on their committees in the name of "personal privacy."

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2000

The FDA recognized the limitations of its SPF rating system for sunscreens, discussing in its consumer magazine the inadequacy of UV-A rating as an "unresolved technical dilemma."   The flaw in the current system is that it only rates the UV-B radiation that causes sunburn and some types of non-malignant skin cancer.   It does not address the UV-A spectrum which has a longer wavelength that penetrates deeper and is responsible for malignant melanoma, the deadliest form of skin cancer.  UV-A damage is also responsible for premature aging of the skin.   This issue was never resolved.

Result: The American Cancer Society estimates that the mortality rate from melanoma has increased 50% since 1973. Nearly 8000 Americans die of the disease every year. Todays sunscreens may create a false and potentially disastrous sense of security in sunscreen users.

2000

Against FDA recommendation, and despite the FDA blockage of the importation of less expensive drugs from other countries, the US Senate and House of Representatives passed a bill that enables Americans to legally obtain lower cost prescription drugs from other countries.

Result: The pharmaceutical industry initiated a scare campaign stating that prescriptions from other countries are "counterfeit" and cannot be trusted, despite the fact that they are often manufactured by these very same pharmaceutical companies. The New England Journal of Medicine (June 22) editorial written by Dr. Marcia Angell attacks the pharmaceutical industries pricing structure. The Wall Street Journal (July 6) criticizes the drug industry's claims that high drug prices are needed to fund research stating that it spends far more (39%) on salesmen than it does on scientists (17%).

2000

Letter from Oligos Etc, Inc. provides an inside look at how the FDA inhibits innovation and how simple it would be to restructure the agency.

2000

FDA asks for ten million dollars to launch attacks on alternative health websites. They wanted to fine internet pharmacies $500,000 for filling FDA-unauthorized prescriptions.They wanted the power to issue subpoenas without first obtaining a court order.   They wanted to set up a "rapid response team" to investigate and prosecute websites.

Result: The FDA already had the power to "protect" consumers on the internet but they wanted to add another bureaucratic layer of law and money to suppress the dissemination of health information.

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1999

FDA suffered a legal defeat in the federal courts when a July 28 ruling gave pharmaceutical companies the right to give doctors copies of published medical studies that highlight their drugs for uses not approved by the FDA.

Result: Drugs like Ribavirin (FDA approved for limited use in 1998) could finally be used to save American lives as it had been doing for many years in other countries. 

1999

FDA loses in "Pearson v Shalala" in an 11-0 massacre.   The court ruled that the FDA had no power to ban nutrient-disease claims unless it had solid evidence that the claims actually mislead.   The court ordered the FDA to abide by the First Amendment free speech provision of the US Constitution. This lawsuit specifically targeted four claims as follows:

• Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers.
• Consumption of fiber may reduce the risk of colorectal cancer.
• Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.
• 800 mcg of folic acid is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form.

1999

FDA approved Tamoxifen as a cancer prevention for healthy women despite objections from women's health organizations and researchers around the world.   This occurred after 15 years of wrangling over research that cost hundreds of millions of dollars.  In the end approval was based on a single study that was stopped 10 years early and showed that the risk of endometrial cancer doubled for women under 50 and quadrupled for women over 50 but the reduction in breast cancer was 1.3% over a placebo. The study chosen by the FDA created fraud and prompted a congressional hearing.

Result: Many died and many developed endometrial cancer, serious eye damage and blood clots. Tamoxifen is also associated with stomach and colorectal cancer. Hormone treatment adds to the risk as does the lifetime dose. In other words, the longer you take it, the higher the risk.

1999

FDA argues against folic acid supplementation. It took the FDA more than 30 years to acknowledge that folic acid prevents neural tube birth defects.

Result: Tens of thousands of deformed babies have been born because the FDA prohibited claims that pregnant women should take folic acid. Studies also indicate that folic acid prevents against colon cancer, cardiovascular disease, and DNA damage.

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1998

Twelve years of FDA initiating several criminal investigations, felony indictments, stock market manipulation, and FDA agents traveling to Europe in an attempt to deny access to the drug Ribavirin instead of properly regulating blood banks. The nation's blood supply became contaminated with the Hepatitis C virus due to millions of squandered tax dollars pursuing a drug that was being used successfully in Europe and other countries to save lives. The drug was the primary treatment for influenza and Hepatitis C.

Result: Massive political pressure over 430,000 dead Americans forced the FDA to finally approve Ribavirin. However, this proved hollow because they only approved it for the limited use treatment of Hepatitis C. Influenza victims continued to die. Hepatitis C patients were required to first fail a grueling six-month therapy period with recombinant interferon-alpha before they could try the Ribavirin + Interferon combination therapy that was proven to work 10 times better than interferon by itself.

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1997

FDA loses a 14-year-old war against cancer pioneer Stanislaw Burzynski, the only doctor in the world with a successful track record for treating inoperable brain cancer with his patented antineoplastons.   The FDA brought 75 bogus felony charges against Burzynski who had been an FDA target for years, with his clinic raided continuously.  The cost to taxpayers was untold millions of dollars. Later the FDA would admit that they can't inspect the food supply adequately due to budgetary constraints.

Result: Prosecutorial misconduct by the FDA was investigated by the Justice Department at the close of the trial.

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1996

The Committee on Government Reform and Oversight issued the report, "Protecting the Nation's Blood Supply from Infectious Agents: The Need for New Standards to Meet New Threats" stating that current FDA and DCD regulatory systems were not adequate and urging greater efforts be made to convey risks to consumers who may wish to use alternative procedures or therapies.

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1994

Lawsuit filed against the FDA by Durk Pearson and Sandy Shaw seeking to allow the following health claim on fish oil supplement labels:   "Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease."   The FDA rejected this claim.

Result: After a seven-year litigation battle costing millions of tax dollars and an onslaught of irrefutable scientific evidence, the FDA capitulated and permitted the following claim:

Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease. FDA evaluated the data and determined that although there is scientific evidence supporting the claim, the evidence is not conclusive.

Today in 2010 there is a fish oil prescription on the market with a list of dangerous side-effects due to the fact that they have dissected the oil and removed the natural elements that make it work safely.

1994

FDA finally approves Glucophage for type II diabetes after several decades of banning its sale in the US stating that it was toxic.   Europeans did not agree and approved its use decades ago.   (Side note: The FDA rapidly approved Rezulin to treat type II diabetes.   Rezulin killed about 391 Americans before it was withdrawn.   Diabetics suffered and died waiting for the FDA to approve the relatively safe drug Glucophage.)

Result: A one-month supply of Glucophage in other countries costs $4.12 due to its "old drug" status, while Americans pay $32.83 for the same quantity.

1994

Congress passed the Dietary Supplement Health and Education Act (DSHEA) that took away the FDA's power to regulate dietary supplements as drugs.

Result: The FDA developed new rules classifying any reference to how supplements affect diseases to be illegal speech. No statements of any kind could be made stating that any disease could be helped with the use of supplements. This caused untold suffering for cancer patients who suffered greatly after chemotherapy because it was illegal to recommend coenzyme Q10 and vitamin E to reduce chemo-induced heart muscle damage, melatonin to reduce chemo-induced immune system damage, and n-acetyl-cysteine to reduce chemo-induced liver damage. The list goes on and on...

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1990

Dr. Joseph Feldschub's book debuts, Safe Blood: Purifying the Nation's Blood Supply in the Age of AIDS.The book documented his father's tragic 1988 death from transfusion acquired hepatitis and how one in 10 transfused patients met with the same fate.   He also explained how the blood industry could be made safer through increased screening for infectious diseases, and how individuals could ensure their personal safety by self-donating and storing their own blood.

Result :   Tests for hepatitis C and AIDS were developed and are now used to test donated blood.

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1989

The FDA restricted the importation of tryptophan.

Result :   Consumers switched to expensive prescription drugs that produced only partial effects.

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1985

Dr. Joseph Feldschub created the worlds first autologous blood bank where people could store their own blood over the long term.

Result :   He was vilified by the blood banking industry, ran afoul of government regulators, and attracted a whole host of professional trouble.

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1982

Dr. Stanley Jacob concluded from his 1978-1982 DMSO studies that, when the human brain was treated with intravenously administered DMSO after a head injury, the swelling was reduced within five minutes.   No other treatment came close to acting that quickly.

Result:   He was forced to start his clinical trials in Europe, where the regulatory environment was more favorable.

Personal Note:   I worked with Dr Jacobs for a frozen shoulder. He sent his proprietary DMSO serum to my young doctor who taught me how to give myself injecitons. It worked beautifully, My physical therapist was amased at how guickluy I recovered... half the time it normally took patients my age.

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1978

After 13 years, the FDA, knowing that the inexpensive compound called dimethyl sulfoxide or DMSO (an approved pharmacological agent in more than 125 countries) offers potent anti-inflammatory and analgesic properties, relieves painful musculoskeletal and urinary conditions, and may even fight Alzheimer's disease and cancer, approved it only for treating interstitial cystitis, or chronic inflammation of the bladder wall.

Result: Many Americans died or suffered needlessly due to ignorance about this inexpensive well kept secret.

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1965

FDA halted all studies of DMSO, even though they had data in their files on more than 70,000 patients submitted by about 1500 physicians in the US showing its safety and effectiveness.

Result:   Despite decades of research and thousands of studies attesting to its health-promoting properties, DMSO remains virtually unknown to medical professionals and the public.

The following statements all apply to the Food & Drug Administration (FDA) based on its actions over the last 70 years. In the interest of brevity, only the past 16 years are listed here. Even thought the FDA has repeatedly lost in the Federal courts, the problem has continued to escalate.  For the past 21 years, evidence exists that the FDA has been the #1 cause of death in the United States. The FDA has caused Americans to die by:

1.   Delaying the introduction of life-saving therapies
2.   Suppressing safe methods of preventing disease
3.   Causing the price of drugs to be so high that some citizens do without
4.   Denying Americans access to effective drugs approved in other countries
5.   Intimidating those who develop innovative methods to treat disease
6.   Approving lethal prescription drugs that kill
7.   Censoring medical information that would let consumers protect their health
8.   Censoring medical information that would better educate doctors
9.   Failing to protect the safety of our food
10.   Misleading the public about scientific methods to increase longevity

The greatest threat the FDA poses to our health is its function as a roadblock to the development of breakthrough medical therapies, thus stifling innovation in medicine and allowing Americans to continue to die from diseases that may have been cured long ago if a free marketplace in drug development existed.

The FDA is now on a rampage to completely control the American public by blocking your access to supplements and information about those supplements that could very well save your life or at the very least improve the quality of life for many who are in need.   We must ask ourselves the question, should "We the People" alter or abolish it?