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Throughout the information presented on this website you will see the notation "not approved by the FDA".
This page is intended to provide some insight into what that means.
There is no doubt that the US FDA has authority.
In fact, the FDA authority over the manufacture, sale and use of drugs is unprecedented in human history.
FDA regulations and approvals are even routinely adopted by foreign governments (such as Australia & New Zealand) for their INTERNAL regulation of products regulated by the FDA in the US.
The FDA has established standards for food processing and manufacture that affect virtually everything we eat or drink. The FDA even requires:
The FDA "Stamp Of Approval" implies a sort of impartial recognition of a productࡴtributes AND an endorsement of the productೡfety when used in accordance with the manufacturer੮structions.
That impression may be, and usually is, highly optomistic.
Medical Devices
The FDA does minimal testing of a device if the manufacturer says it is similar to a device already on the market. This means the impression that a "Surgically Implanted Medical Device" has been "tested and approved by the FDA" is "optimistic", at best and possibly totally false.
The FDA "approves" drugs, but it only "clears" medical devices. This leaves patients at the mercy of device manufacturers, who can easily mislead patients and doctors about the safety of devices.
Case in Point: Several women are suing the manufacturer of a device called a vaginal sling, that is surgically inserted under the urethra to treat urinary incontinence. However, to date over 266 women have reported serious problems with it such as painful, bloody vaginal discharges. the Senior Voice, June 2009, pp11
Drugs and Medicines
In fact, at times it appears the FDA has chosen to "squander" itsꣲedibility for the sake of political advantage or even the economic gains offered by large fees (paid by manufacturers).
Even when the FDA does insist that manufacturers fully disclose side effects, that information might never reach the end user. Much of the most critical information is included in "Black Box" warnings which modify the prescribing information given to medical professionals衲ing that information with a patient is "optional" for the physician.
Bear in mind, the FDA is a GOVERNMENT AGENCY, subject to POLITICAL PRESSURE.
The employees of the FDA are people峴 like us.
Sometimes they make mistakes.
I believe the majority of FDA employees are well educated, highly motivated individuals, operating with "good intentions. However, they have families, mortgages, kids, college tuition(s), car payments, etc. , just like we do.
When they are under pressure, they will do "whatever it takes" to stay employed楮 if itࢮot quite right" just like anybody else.
As you will see in the following paragraphs (mentioned products are only examples...our attention span prohibits a full and inclusive listing), the FDA has "approved" products or treatments that :
You will also see that some products have never received, and never will receive, FDA approval for any given purpose due to:
It is also fair to say that the exclusion of the aforementioned types of information (especially if it happens to be negative) along with the ability of a manufacturer to "bury" unfavorable test results may lead to "approvals" that are not entirely in the public interest.
(When a Manufacturer pays for a study, it "owns" the results. Such results are not necessarily included in the information submitted for FDA approval. Researchers are routinely barred from releasing test or study results without the prior approval of the "sponsor". After all, the sponsor "paid for" and "owns" that information. Giving away property that you do not own is theft.)
"As a part of the Department of Health and Human Services (DHHS), FDA's mission is to promote and protect the public health by ensuring that safe and effective products reach the market in a timely way, and to monitor products for continued safety after they are in use. FDA's mission is a blending of science and law directed at protecting consumers by focusing on patient, food, and consumer safety.
To fulfill its mission as effectively as possible, FDA must allocate its available resources to have the greatest impact on public health given the risks and opportunities available."
To achieve these ends, the FDA, in FY 2004, budgeted 1.7 billion dollars.
1.4 billion of that amount was derived from the national budget
300 million dollars was derived from "user Fees". This amounts to roughly 17.6% of the total annual budget. Of this 300 million dollars, $249,825,000 is requested to support the Prescription Drug User Fee Act. (end of quote)
To say the very least, the FDA has a meaningful stake in the use of "controlled substances".
Additionally, the FDA (an agency dependant upon public funds) is highly susceptible to political pressure奠"aspartame" below.
In order to get an FDA approval, for any medicinal product (or presumably food additive), a corporation (the FDA has a long standing policy of not issuing approvals to individuals) must present data showing levels of toxicity, efficiency for the specified use, etc.
The data must be supported by test results, double blind trials (where the participants & test monitors do not really know who is getting what substance until the trial is completed), human trials etc.
Not counting FDA fees, the process of obtaining an FDA approval is expensive (some estimates for drug approvals range from $10,000,000 to $150,000,000 per approval).
To say the least, no Corporation is going to expend that amount of funds unless there is a reasonable probability of making a profit.
If a product壨 as silver㠮ot patentable毮t color="#000080">there will be no FDA approval
, because no corporation will even apply for one. No patent means no profit.The following list has some products with medical uses, commonly acknowledged to work, that do not have FDA approvals. This list of examples is short, and by no means complete, but it does provide some insight into the fact that an FDA approval is not REQUIRED for a product to perform any given function.
The fact that a product (food or drug) has FDA approval will not, in and of itself, guarantee that the product is "safe" or that it will actually perform as described.
The example of "VIOXX" comes right to mind if we are speaking about drugs.
"On September 30, 2004, the international prescription drug company Merck announced the recall of its arthritis and pain medication Vioxx because a study showed an increased risk of heart attack and stroke. The study that led to the recall of Vioxx showed that patients regularly taking Vioxx faced twice the risk of a heart attack compared to patients not taking Vioxx." [www.vioxxlegalresources.com/ ]
"In May 2000, executives at Merck, the
pharmaceutical giant under siege for its handling of the
multibillion-dollar drug Vioxx, made a fateful decision. The company's
top research and marketing executives met that month to consider
whether to develop a study to directly test a disturbing possibility:
that Vioxx, a painkiller, might pose a heart risk. Two months earlier,
results from a clinical trial conducted for other reasons had suggested
such concerns.
Merck decided not to conduct a study solely to determine whether Vioxx
might cause heart attacks and strokes - the type of study that outside
scientists would repeatedly call for as clinical evidence continued to
show cardiovascular risks from the drug. Instead, Merck officials
decided to monitor clinical trials, already under way or planned, that
were to test Vioxx for other uses, to see if any additional signs of
cardiovascular problems emerged.
It was a recurring theme for the company over the next few years - that
Vioxx was safe unless proved otherwise. As recently as Friday, in
newspaper advertisements, Merck has argued that it took "prompt and
decisive action'' as soon as it knew that Vioxx was dangerous. But a
detailed reconstruction of Merck's handling of Vioxx, based on
interviews and internal company documents, suggests that actions the
company took - and did not take - soon after the drug's safety was
questioned may have affected the health of potentially thousands of
patients, as well as the company's financial health and reputation." [November
14, 2004 The New York Times, "In Face of Warnings, Drug Giant
Took Long Path to Vioxx Recall" ]
"Merck knew it had trouble
on its hands and took action. At the same time, instead of acting as a
public watchdog, the Food and Drug Administration was busy challenging
its own expert and calling his work 'scientific rumour.' "
source of the preceding quote [link]
[http://www.fda.gov/ohrms/dockets/dailys/04/oct04/101504/02p-0317-emc00376.txt]
Prozacuote Marilyn Elias | Sep 14 '04 issue of USA Today " BETHESDA, Md. -- Prozac, the only antidepressant certified as safe for children, may make kids more suicidal, according to evidence out Monday.
A large, new study added to previous research on Prozac shows that kids taking the drug have about a 50% higher risk of suicidal thoughts and suicide attempts than those getting placebosꏴher major antidepressants prescribed for kids already have been found to raise the risk of suicidal behavior. Prozac had been an exception. "What's interesting and persuasive is that these studies now all lean the same way," Temple says." (Robert Temple, director of the Office of Drug Evaluation at the FDA..ed) ⼢>Dozens of parents testified at the hearing that antidepressants had caused their children to kill themselves -- or others. Their claims were "passionate and plausible," says psychiatrist Wayne Goodman, chairman of the FDA advisory panel. 꼦ont color="#000080">Drug company spokesmen argued that antidepressants are safe. Company studies show most suicide attempts by children on Zoloft are linked to stress, not to taking the drug, says Steve Romano of Pfizer Inc., which makes Zoloft.
Although antidepressants seem to generate more suicidal behavior, "we can't forget all those who are protected from suicide by treatment," Goodman says." (龓ilver Bullet editor࣯mment..When a Manufacturer pays for a study, it "owns" the results. Such results are not necessarily included in the information submitted for FDA approval or made available to the general public. Researchers are routinely barred from releasing test or study results without the prior approval of the "sponsor". After all, the sponsor "paid for" and "owns" that information. Giving away property that you do not own is theft.)
Paxil an FDA "Approved" drug for depression 寴ing FDA TALK PAPER.. T03-43 June 19, 2003
"Three well-controlled trials in pediatric patients
with MDD failed to show that the drug was more effective than placebo.
The new safety information that is currently under review was derived
from trials of Paxil in pediatric patients.
Following its review of the same data, the
UK Department of Health issued
a Press Release on June 10 stating that paroxetine (brand name Seroxat
in the UK) must not be used to treat children and teenagers under the
age of 18 years for depressive illness because UK authorities have
concluded that there is an increase in the rate of self harm and
potentially suicidal behavior in this age group, when paroxetine is
used for depressive illness."
Quoting "the Hormone Replacement Therapy Information Resource" [http://www.hrt-info.com/index.html]
"For many years, women have been prescribed hormone replacement drugs as therapy for symptoms associated with menopause. 幯nd treating symptoms associated with menopause, doctors also believed that hormone replacement therapy (HRT) also protected women from the risks of osteoporosis, heart disease and other ailments associated with aging.
In 1993, the Women's
Health Initiative (WHI), a project sponsored by National Institutes of
Health (NIH), began a study of approximately 160,000 women aged 50 -
79. Part of the WHI study examined the benefits and risks associated
with hormone replacement therapy (HRT), studying approximately 16,600
women.
In July 2002, the portion of WHI study
involving women who were prescribed combination hormone replacement
therapy (HRT) was halted due to the increased risks of breast cancer
that were observed in the study༯font>
Also in 2002, the
National Cancer Institute published a study that suggested an
association between the use of estrogen-only hormone replacement
therapy (HRT) and the development of ovarian cancer. The data suggested
that the risk of developing ovarian cancer increased with the length of
time estrogen-only HRT was used.
From 1960 until 2002, hormone replacement therapy (HRT) evolved as a generally accepted, first-line treatment option for women experiencing the effects of menopause. Moreover, hormone replacement therapy (HRT) was also touted for it protective benefits - offering women protection from increasing risks of osteoporosis, heart disease, Alzheimer's disease, and other age-related ailments.
Until the late 1970s, Premarineth's blockbuster
estrogen-only, hormone replacement drug, was the "cure" of choice for
menopause and its dreaded effects. At its peak, Premarin祮erated
approximately 30 million prescriptions annually. However, beginning in 1976, scientific studies
demonstrated that estrogen-only therapy was associated with an
increased risk of uterine (endometrial) cancer among women who used
such drugs. (gee, it only took 26 years to let
consumers know the risks鬶er bullet editor)
Findings
The data collected by the Women's Health Initiative (WHI) and the
National Cancer Institute demonstrated that the use of both combination
(estrogen and progestin) hormone replacement therapy (HRT) and
estrogen-only hormone replacement therapy (HRT) carried certain health
risks.
For combination (estrogen and progestin) hormone replacement therapy
(HRT), the data indicated the following:
For estrogen-only hormone replacement therapy (HRT),
the data suggested that the risk of developing ovarian cancer increased
with the length of time estrogen-only HRT was used. According to this
study, women who were using estrogen-only hormone replacement therapy
(HRT) for 20 years or longer are subject to a three-fold greater risk
of developing ovarian cancer than women who did not use such therapy.
HRT & non-Hodgkins lymphoma
In 2002, Cerhan, J. et
al reported the results of their study of 37,220 women living in Iowa
with no prior history of cancer. The results of the study, published in
the November, 2002 issue of Cancer Epidemiology Biomarkers and
Prevention, concluded that women taking hormone replacement therapy
(HRT) were at greater risk for developing a particular B-cell type of
non-Hodgkins lymphoma known as Follicular Cell Lymphoma, particularly
the Nodal form of the disease. Nodal Follicular Cell Lymphoma involves
clusters of cancerous B-cells within a lymph node. This type of
non-Hodgkins lymphoma tends to be indolent or low-grade, i.e.
slow-growing.
The strongest association between Follicular Cell Lymphoma and hormone
replacement therapy occurred in women who were current users
estrogen-only HRT (drugs like Premarin and Estradiol) - a 3.3 increase
in risk over women who had never used HRT. For women who were current
uses of estrogen-only HRT for more than 5 years, there was a 3.9 times
greater risk than those who never used HRT. For former users of
estrogen-only HRT, the risk was 2.6 times greater.
Gall Bladder Cancer and Hormone Replacement
Therapy (HRT)
In 2002, the
results of a case control study conducted in Italy demonstrated that
women who had a history of using hormone replacement therapy (including
drugs such as Premproвoveraвemphaseвemarin, Estradiol,
FemHRTᮤ the generic medroxyprogesterone acetate) were three times
more likely to develop Gall Bladder cancer than women who had never
used hormone therapy. The study, reported in the International Journal
of Cancer, also indicated that the longer hormone therapy was used, the
greater the risk of developing Gall Bladder cancer.
Although the incidence of Gall Bladder cancer is rare - approximately
4,200 cases in women diagnosed annually, the findings of the Italian
study "⯶ide the first epidemiological evidence of an association
between HRT and Gall Bladder cancer." [Drs. Silvano Gallus and Eva
Negri, co-authors of the study] The study was funded by the Italian
Association for Cancer Research."
END OF QUOTED SECTION
HRT & Hearing Loss
BBC NEWS Wednesday, 25 February, 2004
"A team from the University of Rochester Medical Center in the US found women who had HRT were up to 30% more hard of hearing than other women.
They studied two groups of 32 women and measured their hearing in noisy areas and ability to process informationԨe women were tested by being asked to decipher sentences while listening to someone talking in a noisy area.
The team found women who had undergone HRT suffered a particular type of age-related deafness called presbycusis.
Presbycusis is a condition where high pitched sounds are harder to hear, while deeper, lower sounds are magnified. For example, it would be easier to hear a man's voice than a woman's.
It can be linked to physical changes in the middle ear or to complex changes in the nerve pathways leading to the brain.
The researchers are unsure why hormone therapy would have this effect. "
Alzheimer's disease & HRT [http://www.breastcancer.org/research_hrt_alzheimers.html]
Sally A. Shumaker et al., Journal of the American Medical Association, May 28, 2003
Background and importance of the study: In the past, doctors advised post-menopausal women to take the hormones estrogen and progestin to help relieve symptoms of menopause. This hormone replacement therapy (HRT) was thought to help strengthen bones and prevent heart disease. A few small studies also suggested that HRT might lower a woman's risk of developing Alzheimer's disease. ﰾ
Study design: For about four years, more than 4,000 women who were 65 or older received either estrogen and progestin or a fake (placebo) pill. Neither the women nor their doctors knew whether the women were receiving HRT or the placebo. Researchers made that decision randomly to get two similar groups of women, so that at the end of the study they could make solid comparisons.
If the women had chosen their own treatment, the groups might not have been balanced. For example, more health-conscious women might have chosen to take HRT. These women might also have been more likely to do things (such as eating a healthier diet or getting more daily exercise) that lowered their risk of developing the diseases HRT was thought to protect against. In that case, it would have been impossible to tell what was protecting the women: their healthier lifestyle or the HRT.
The researchers compared the number of women who developed Alzheimer's disease during the study period in the two groups: the group of women who got the placebo and the group that got HRT.
Study results: During the study, 21 women in the placebo group and 40 in the HRT group were diagnosed with major thinking impairments (dementia) most likely caused by Alzheimer's disease. (Alzheimer's disease can only be diagnosed for sure by an autopsy after a person dies.) This means that the women who took HRT had double the risk of developing dementia of the women who took the placebo.
Conclusion: The researchers concluded that HRT did not protect women from Alzheimer's disease. Instead, it appeared to increase their risk of developing this disorder. These findings also support the conclusions of previous studies that the risks of taking estrogen and progestin on a long-term basis outweigh the benefits for most women.
ASPARTAME...an FDA approved food additive...subject of multiple lawsuits due to consumer injury...allegations of FDA wrong doing (evildoers in the US FDA?)
If we are only thinking about "food additives", Aspartame comes to mind. Aspartame is one of the most common synthetic food additives.
The FDA licensed it for use in 1981.
To quote Roberta Bellon, National Justice League, April 6, 2004
Aspartame causes headache, memory loss, seizures, vision loss, coma and cancer. It worsens or mimics the symptoms of such diseases and conditions as fibromyalgia, MS, lupus, ADD, diabetes, Alzheimer's, chronic fatigue and depression.
Aspartame liberates free methyl alcohol. The resulting chronic methanol poisoning affects the dopamine system of the brain causing addiction. Methanol, or wood alcohol, constitutes one-third of the aspartame molecule and is classified as a severe metabolic poison and narcotic.
Recent news is full of reports of world-class athletes and other healthy consumers of aspartame suddenly dropping dead. Sudden death can occur from aspartame use because it damages the cardiac conduction system.
Dr. Woodrow Monte in the peer reviewed journal, Aspartame: Methanol and the Public Health, wrote: "When diet sodas and soft drinks, sweetened with aspartame, are used to replace fluid loss during exercise and physical exertion in hot climates, the intake of methanol can exceed 250 mg/day or 32 times the Environmental Protection Agency's recommended limit of consumption for this cumulative poison."
The effects of aspartame are documented by the FDA's own data. In 1995 the agency was forced, under the Freedom Of Information Act, to release a list of ninety-two aspartame symptoms reported by thousands of victims. This is only the tip of the iceberg. H. J. Roberts, MD, published the medical text "Aspartame Disease: An Ignored Epidemic" -- 1,000 pages of symptoms and diseases triggered by this neurotoxin including the sordid history of its approval
Since its discovery in 1965, controversy has raged over the health risks associated with the sugar substitute. From laboratory testing of the chemical on rats, researchers have discovered that the drug induces brain tumors. On Sept 30, l980 the Board of Inquiry of the FDA concurred and denied the petition for approval. In l981, the newly appointed FDA Commissioner, Arthur Hull Hayes, ignored the negative ruling and approved aspartame for dry goods. As recorded in the Congressional Record of 1985, then CEO of Searle Laboratories Donald Rumsfeld said that he would call in his markers to get aspartame approved. Rumsfeld was on President Reagan's transition team and a day after taking office appointed Hayes. No FDA Commissioner in the previous sixteen years had allowed Aspartame on the market.
In 1983, aspartame was approved for use in carbonated beverages. Today it is found in over 5000 foods, drinks and medicines.
Numerous lawsuits are currently pending against the manufacturers of aspartame.
The bottom line is this:
The presence or Absence of an FDA approval, in and of itself does not clearly indicate whether a product will or will not work as advertised.
The presence or Absence of an FDA approval, in and of itself does not clearly indicate whether a product is safe or unsafe.
I have no clear notion about how to "Fix" the FDA.
What FDA Insiders Tell The Senate Nov 18, 2004
We are not licensed Medical Professionals. We endeavor to provide accurate and useful information BUT we do not guarantee the accuracy of information on this site or any site to which we have linked. We specifically deny all liability for the use of any information on this site. We strongly recommend consultation with licensed professionals prior to beginning, ending or changing the course of treatment for any medical condition.
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