I know I said this ended in 2008
but I couldn't resist reporting on just one more FDA announcement below:
Scientists and statistics have already proven that cholesterol
medications like statin drugs, while lowering
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.
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..
* * *
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.
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."
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.
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.
Americans are once again able to treat
their serotonin deficiency disorder with this simple amino acid.
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.
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
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.
Americans were left at risk.
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)
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.
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.
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.
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.
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.
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.
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.
November 8, 2001, when talks with the FDA were not going to Merck's liking, the
head of Merck's research department sent an email to his top scientists stating:
"Twice in my life I have had to say to the FDA, "That label is unacceptable, we
will not under any circumstances accept it." ... I assure you I will NOT sign
off on any label that has a cardiac warning for Vioxx."
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
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.)
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 it's supposed to regulate.)
Conclusion: As long as the FDA remains beholden to the
pharmaceutical companies, financially and otherwise, it is unable to protect the
American public. Given its recent history, there is no reason to believe that
the FDA can reform itself. The only hope is that Congress act to dismantle and
rebuild the FDA, dividing the power into more than one impartial organization.
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
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."
Quote: "There is something terribly rotten at the FDA," Rep.
Peter Deutsch from Florida told the Los Angeles Times after Mosholder's
testimony. "No agency charged with protecting the public health should have
behaved with such indifference."
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.
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.
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.
The FDA allows the following health claim on products containing the omega-3
fatty acids eiscosopentaenoic acid (EPA) and docosahexaenoic acid (DHA):
Supportive but not conclusive research shows that consumption of EPA and DHA
omega-3 fatty acids may reduce the risk of coronary heart disease.
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.
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
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:
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
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.
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.
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.
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.
Later the FDA would develop a "compassionate use" clause to make
experimental drugs available to advanced cancer patients.
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.
FDA allows the research firm, Geron Corporation, to enter into a Phase I study
for the cancer vaccine Telomerase 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
The FDA supported an Oklahoma action against a pharmacy obtaining Canadian Drugs
for US customers.
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
Result: The FDA continues with its extraordinary efforts to
censor information about proper diet and supplementation.
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."
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
This later proved to be a public relations stunt.
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.
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,
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)
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.
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.
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.
FDA reform is called for but not delivered.
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
FDA scandal attracts media attention when it's 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
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. Today's sunscreens may create a false and
potentially disastrous sense of security in sunscreen users.
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%).
Oligos Etc, Inc. provides an inside look at how the FDA inhibits innovation
and how simple it would be to restructure the agency.
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
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.
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.
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.
Result: The FDA completely disregarded the court ruling and
continued to suppress the folic acid claim, depriving the public of health
information vital to every fertile American woman. Another lawsuit had to be
brought two years later, at great taxpayer expense, to force them to comply with
the original ruling.
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.
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.
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.
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
Prosecutorial misconduct by the FDA was investigated by the Justice
Department at the close of the trial.
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.
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
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.
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.
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...
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.
Tests for hepatitis C and AIDS were developed and are now used to test
restricted the importation of tryptophan.
Consumers switched to expensive prescription drugs that produced only
Feldschub created the world's first autologous blood bank where people could
store their own blood over the long term.
He was vilified by the blood banking industry, ran afoul of government
regulators, and attracted a whole host of professional trouble.
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.
He was forced to start his
clinical trials in Europe, where the regulatory environment was more favorable.
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.
Many Americans died or suffered needlessly due to ignorance about this
inexpensive well kept secret.
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
Despite decades of research and thousands of studies attesting to its
health-promoting properties, DMSO remains virtually unknown to medical
professionals and the public.
Declaration of Independence signed July 4, 1776,
addresses "Life, Liberty and the pursuit of Happiness. -
That whenever any Form of Government becomes destructive
of these ends, it is the Right of the People to alter or to
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:
Delaying the introduction of life-saving
Suppressing safe methods of preventing
Causing the price of drugs to be so high that
some citizens do without
Denying Americans access to effective dfrugs
approved in other countries
Intimidating those who develop innovative
methods to treat disease
Approving lethal prescription drugs that kill
Censoring medical information that would let
consumers protect their health
Censoring medical information that would
better educate doctors
Failing to protect the safety of our food
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
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
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