Dr Joseph Mercola eHealthy News You Can Use
May 8, 2002 - Issue 322
Link Seen Between Cooking and Cancer
By Mark Kaufman
The process of frying and baking starchy foods such
as potatoes and bread causes the formation of potentially harmful
amounts of a chemical listed as a probable carcinogen.
Swedish officials said they were so surprised by the information that
they decided to make it public immediately, rather than wait for
publication in a scientific journal.
The chemical, acrylamide, which is used industrially in the
manufacture of some plastics, is also apparently formed by the heating
of starches. Foods with especially high levels of the chemical
included french fries, potato chips and crackers.
The governmental agency, following up on research by a group of
scientists at Stockholm University, studied more than 100 foods bought
in Swedish stores and restaurants and determined that "fried,
oven-baked and deep-fried potato and cereal products may contain high
levels of acrylamide."
The high acrylamide levels were initially discovered during a
University of Stockholm study at a factory that used them
industrially.
A Food and Drug Administration official said that the agency had not
reviewed the report but that it considered the source to be
"credible."
The Swedish report said that high doses of acrylamide have been shown
to cause cancers and that "it seems reasonable to conclude that a
significant number, perhaps several hundred, of the annual cancer
cases in Sweden can be attributed to acrylamide."
The U.S. Environmental Protection Agency describes acrylamide as
white, odorless, flake-like crystals that are used mainly in treating
drinking water and for industrial purposes and can cause cancer in
people exposed to high levels for a long period.
Findings unveiled at a news conference called by the food
administration showed that an ordinary bag of potato crisps may
contain up to 500 times more of the substance than the top level
allowed in drinking water by the World Health Organization (WHO).
WHO recommends one microgram (one-millionth of a gram) per litre as a
maximum permitted for drinking water.
Researchers were surprised by the high levels found in both the
workers and the people used for a control study. The Swedish
government began testing acrylamide levels late last year and found
that they were elevated in many starch-rich foods that had been baked
or fried. They were not found, however, in raw or boiled foods,
leading researchers to conclude they were formed by the cooking
process.
Washington Post , April 25, 2002; Page A13
Dr. Mercola,s Comment:
No real rocket science here. Breads and
most grain products, like potatoes, are not good for you anyway. Is it
any surprise that when you heat them at high temperatures even worse
things will happen?
Raw foods are key to your health. Most cooked foods will lose valuable
nutrients due to their fragile nature. However, high temperatures will
also potentially cause formation of carcinogenic substances as this
study shows.
This has been shown for cooking meats over a grill in which
heterocyclic amines are formed
My eating plan emphasizes the need for at least one-third of
your foods being consumed as raw.
This can even be translated to meats. I have recently started eating
raw ostrich, that was raised primarily on alfalfa, several times a
week and find it quite delightful.
I have been consuming raw egg yolks for several months now with major
benefits to my cholesterol level. The egg whites are one of the clear
exceptions to raw food as they should be cooked to avoid biotin (a B
vitamin) depletion.
I am not sure that eating a completely raw diet is practical for most
people, including me, but I do believe it is likely the higher
percentage of your food that is uncooked, or minimally cooked, the
healthier it will be for you.
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Dr. Joseph Mercola, eHealthy News You Can Use,
Issue 292 January 23, 2002
Warning: New
Hepatitis Vaccine Recs Can Devastate Newborn's Health
The newly released 2002 immunization schedule encourages the routine
use of hepatitis B vaccine for all infants before hospital discharge
to safeguard against maternal hepatitis B testing errors and test
reporting failures, protect neonates discharged to households in which
hepatitis B chronic carriers other than the mother may reside (and)
enhance the completion of the childhood immunization series.
The annual "Recommended Childhood Immunization Schedule" of the
American Academy of Pediatrics (AAP), the Advisory Committee on
Immunization Practices (ACIP) of the Centers for Disease Control and
Prevention (CDC), and the American Academy of Family Physicians (AAFP)
is issued in January of each year.
Pediatrics Vol. 109 No. 1 <http://www.pediatrics.org/cgi/content/full/109/1/162>
January 2002, pp. 162
How Serious Is a Hepatitis B Infection?
The numbers speak for themselves.
Approximately 50% of patients who contract Hepatitis B develop no
symptoms after exposure.
However, the exposure ensures that they will have life-time immunity.
An additional 30% develop only flu-like symptoms, and again, this
group will acquire life-time immunity.
Of the remaining 20% exposed to Hepatitis B will develop the symptoms
of the disease. 95% of this 20% will fully recover, with life-time
immunity.
Therefore, less than 5% of people who contract Hepatitis B will become
chronic carriers of the infection.
The numbers get even smaller: of that 5%, nearly 75% (or 3.75% of the
total exposed) will live with an asymptomatic infection and only 25%,
(or only 1.25% of the total number of people exposed) will develop
chronic liver disease or liver cancer, 10-30 years after the acute
infection. (Hyams, K.C. (1995) Risks of chronicity following acute
hepatitis B virus infection: A review. Clin. Infect. Dis. 20,
992-1000.)
Think of that in terms of probability: the possibility of contracting
the disease is exceedingly difficult for children and only 1.25% of
those that are exposed will actually develop the most serious
complication!
This type of a "protecting the needle in the haystack" medicine is
absurd at best, dangerous at worst.
The Vaccine Adverse Event Reporting System (VAERS) was developed by
the government to report vaccine reactions. Many experts believe that
only 10% of the adverse reactions are reported though as reporting is
not mandated by law.
Even with only 10% of the problems being reported there were nearly
25,000 VAERS hepatitis B reports from July 1990 to October 31,
1998, showing 439 deaths and 9673 serious reactions
involving emergency room visits, hospitalization, disablement or
death.
The presence of findings such as brain edema in healthy infants who
die very soon after receiving hepatitis B vaccine is profoundly
disturbing, especially in view of the frequency of neurologic
symptoms in the VAERS.
Does this make any
sense?
Is Hepatitis B Vaccine Effective in Newborns?
Vaccine derived immunity is thought to be short lived. Between 30-50%
of vaccinated individuals lose their antibiodies within 7 years.
Up to 60% of persons who initially respond will lose detectable
antibodies within 12 years.. So that means that these vaccines will
provide little to no protection to the real risks of acquiring
hepatitis B, promiscuous sexual behavior and IV drug abuse.
Does this make any sense?
How Many Children Are Hurt or Helped By Hepatitis B Vaccine?
Hepatitis B is a rare, mainly blood-transmitted disease. In 1996 only
54 cases of the disease were reported to the CDC in the 0-1 age group.
There were 3.9 million births that year, so the observed incidence of
hepatitis B in the 0-1 age group was just 0.001%. In the Vaccine
Adverse Event Reporting System (VAERS), there were 1,080 total reports
of adverse reactions from hepatitis B vaccine in 1996 in the 0-1 age
group, with 47 deaths reported.
Let us put this in simpler terms. For every child with hepatitis B
there were 20 that were reported to have severe complications. Let us
also remember that only 10% of the reactions are reported to VAERS, so
this means:
Traditional medicine is harming 200 children to protect one from
hepatitis B.
Does this make any
sense?
How Many Safety Studies Have Been Done On Hepatitis B Vaccine?
None.
A manufacturer's representative was asked in a 1997 Illinois Board of
Health hearing to show evidence that the hepatitis B vaccine is safe
for a 1-day old infant. The representative stated:
"We have none. Our studies were done on 5- and 10-year-olds."
--The Congressional Quarterly, August 25, 2000, pg. 647
One would think that these would be mandatory, but they are not. All
that is required is to show efficacy, (i.e. that the vaccine
stimulates an antibody response after it is given), not safety.
In most other industries the fraud represented here would lead to
criminal charges.
Please tell every pregnant woman you know about this issue. They
need to know the facts BEFORE they are in the hospital and have
time to make an informed objective decision. If they are still
convinced their child needs hepatitis B vaccine, beg them to make sure
their child does not receive the vaccine as a newborn. Delay the
vaccine until they really are at a possible risk, like late
adolescence.
I am not asking much here. Only some compassion for the helpless. If
you have ever seen the agony of families who are struggling with
****** for brain injured children you will know what I mean.
I have shown dozens of times in this newsletter, drugs that are
thought to be safe are pulled from the market after they have killed
dozens or hundreds of people. I am hopeful that hepatitis B
vaccinations in newborns will be stopped. Medical science will have to
recognize the truth sooner or later.
Folks, drug deaths pale in comparison to the devastation in lost lives
that is resulting from implementation of this hepatitis B
recommendation.
You can play a large role here. Most of all us did not have a chance
to make a difference in the 9/11 tragedy, but nearly everyone of us
can help protect the precious brain cells of a newborn.
Don't Delay.
Contact every pregnant woman you know immediately. Save a life.
God Bless you in your efforts to protect the future of our
civilization.
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'Wonder
drug Cipro could kill'
Date: Mon, 22 Oct 2001 06:04:00 -0400
Times of London, OCTOBER 20 2001
'Wonder drug Cipro could kill'
FROM KATTY KAY IN WASHINGTON
DOCTORS in America fear that more people could die from taking the
antibiotic Cipro unnecessarily than are at risk from the anthrax attacks
themselves.
As Americans flocked to their doctors to demand prescriptions for Cipro,
the "wonder drug" of the anthrax scare, health officials warned the
public of serious side-effects. Many people who have not even been close
to an anthrax incident are hoarding the drug just in case. Others are
taking it as a prophylactic because they may have been exposed. Doctors
said that those precautionary measures could cause serious problems.
The potential side-effects of taking Cipro range from nausea and
headaches to seizures and hallucinations. One in ten people who takes
Cipro suffers effects to the brain, including hallucinations, mood
changes and nightmares. While the most acute reactions are rare, they
can be
life-threatening.
Giving Cipro to children is particularly problematic since it can damage
the cartilage in joints, particularly in young bodies. Doctors said it
should be given to children only when absolutely necessary.
Dr Michael Miller, Professor of Immunology at Albany Medical College,
said: "My concern is that there may eventually be unnecessary deaths
because of this."
<http://www.thetimes.co.uk/article/0,,2001350020-2001364029,00.html>
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Warning Over Epilepsy Treatment
in the US
US patients using an epilepsy drug called Topamax (topiramate) should
contact their doctor if they experience blurred vision or eye pain
because the drug could cause a type of glaucoma. Manufacturer
Ortho-McNeil Pharmaceuticals issued a warning to more than 500,000
doctors who prescribe the drug to both adults and children. Stopping the
drug immediately seems to prevent the side effect, but if left untreated
it can lead to serious eye problems, including permanent vision loss.
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Psychiatrist
Launches Lawsuit
After Criticising Antidepressant
A psychiatrist has launched a $4.3 million court case in Canada,
claiming he lost a $180,000-a-year job for criticising Prozac (fluoxetine).
Dr David Healy claims that the job offer from the University of Toronto
and an affiliated teaching hospital was revoked the week after he linked
the antidepressant drug to higher suicide rates. Dr Healy claims his
future employers baulked at the comments, made in a lecture, because
Prozac's manufacturer Eli Lilly had contributed $650,000 to the teaching
hospital. Vivek Goel, vice-provost for the university, claimed that he
was surprised that the university had been named in the suit, and that
university's own investigations suggested that the drug company did not
play a role in the decision to revoke Dr Healy's offer.
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FDA asked for heart drug warning
BETHESDA, Md. (AP) - A federal advisory committee decided Thursday that
physicians need to have more information regarding the use of the heart
drug Cardura, but they made no decision on changing the label. Committee
chairman Dr. Jeffrey Borer, a cardiologist at Cornell University in New
York, said the consensus of the committee was that more data from a
federal study should be communicated to physicians, but "the forum is
not defined." Borer chaired an FDA advisory committee called to hear a
citizen's petition demanding that instructions on the label for the
heart drug be changed and that a warning be sent out because of a study
that linked the drug to congestive heart failure and stroke.
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Medical errors said greater in
kids
CHICAGO (AP) - Potentially harmful medication errors occur three times
more often among hospitalized children than adults, according to a new
study. Many mistakes - including prescribing medication at incorrect
dosages or drugs that could cause allergic reactions - could be
prevented by requiring physicians to enter orders into a computer and
clinical pharmacists to be more involved in pediatric wards, researchers
said. In the six-week study at Children's Hospital Boston and
Massachusetts General Hospital for Children, researchers found 616
medication errors out of 10,778 orders written - an error rate of 5.7%.
Of those, 26 were considered adverse drug events, meaning they harmed
the child. In 115 cases, the mistakes were caught before the medication
was administered or the error did not cause a bad reaction; of those,
physician reviewers said 18 were potentially fatal or life-threatening.
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Demands for Zyban ban
The father of an air stewardess who died shortly after taking Zyban is
calling on the Government to tighten controls on the controversial
anti-smoking drug. Kerry Weston, 21, collapsed and died in January after
taking Zyban for just two weeks. Ms Weston's father, Eddie Weston, has
been granted a meeting with the head of the Government's Medicines
Control Agency (MCA), Alisdair Breckenridge, on Wednesday to discuss his
concerns.
Mr Weston said: "Ideally, I would like to see Zyban taken off the market
until more research is done into its safety." An inquest ruled that Zyban, together with the anti-malaria drug chloroquine and an
over-the-counter treatment for insomnia, contributed to Ms Weston's
death from epileptic seizure.
However, the MCA maintains that Zyban is safe, while a spokesman for the
Department of Health said: 'In the majority of fatal cases, the
individual's underlying condition may provide an alternative
explanation.' Latest government figures show that 50 people have died
after taking Zyban and 6460 have suffered suspected adverse reactions.
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Dr. Joseph Mercola, eHealthy News You Can Use, August 29th,
2001 - Issue 250
Do You Have Sweaty Hands and Feet? Medicine's
Answer? Cut Out the Nerves!
About one person in 500 suffers
from hyperhidrosis, the cause of which is unknown, explained Keller, who
says he has performed 250 surgical procedures to correct the
sweating disorder over the last 3
years.
Cutting a nerve located in the chest cavity can effectively dry up
hyperhidrosis -- a debilitating condition that causes
excessive sweating of the hands and feet
-- and greatly improve patients' quality of life, according to a report.
It has been known for decades that cutting a specific nerve can often
stop sweating, but many people shied away from these types of chest
surgery procedures.
Now, recent surgical advances allow surgeons to operate through
incisions about a half-inch long
made in the armpit. A tiny scope with a TV camera is inserted into the
incision and moved along the chest until it reaches the nerve associated
with excessive sweating. The probe is also fitted with a cutter that is
used to sever the nerve, thus stopping the signal from the brain to the
hands.
The effect is immediate and permanent, especially with sweating of
the hands, but sweating of the feet is another story. Since the nerves
to the feet take a different route, the feet often
continue to sweat after surgery.
The procedure is not without side effects. About
50% of patients experience
compensatory sweating on the abdomen, back or thighs, but this sweating
is often not nearly as severe as was experienced on the hands.
In addition, some patients -- less than 1% -- experience a droopy
eyelid, "but another surgery can fix this," he said.
International Symposium of Sympathetic Surgery, Helsinki, Finland.
June 2001
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Dr. Joseph Mercola, eHealthy News You Can Use, August 29th,
2001 - Issue 250
Doctors Ignore Acne Drug Birth
Defect Warnings
The US Centers for Disease Control and Prevention
(CDC) released a report indicating that some women taking the acne drug
Accutane become pregnant despite efforts to warn them that the product
is known to cause severe birth defects.
The CDC also said that a symbol used to remind women of the teratogenic
effects of medicines is commonly misinterpreted. A teratogen is a
substance that causes birth defects.
According to the agency, current recommendations for Accutane suggest
that women have two negative pregnancy tests, including one on the
second day of their next normal menstrual period, before taking the
medication. Additionally, women taking Accutane should use two forms of
birth control, have repeat pregnancy tests every month and register with
a survey that monitors the experience of women taking the drug.
The CDC said that over 2,000 pregnancies in US women taking Accutane
were reported to the Food and Drug Administration (FDA) between 1982 and
March 2000. In its report, the CDC also said that many uncounseled women who saw the
teratogen warning symbol -- a pregnant woman depicted in a circle with a
slash through it -- were unable to tell what it meant. Many women
confused medication bearing this symbol with birth control.
Centers For Disease Control, Atlanta, GA August
17, 2001
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Dr. Joseph Mercola, eHealthy News You Can Use, August 29th,
2001 - Issue 250
Arthritis Drugs Have New Warnings, but
Will the Doctors Listen???
Johnson & Johnson's labeling for its drug Remicade
will be updated with a boxed warning stressing that the drug can
increase the risk of infections.
The company's statement comes just 2 days before an advisory committee
to the US Food and Drug Administration (FDA) is scheduled to discuss
whether stronger warnings are needed for Remicade and Enbrel.
The drugs are tumor necrosis factor (TNF) blocking agents. In excessive
amounts, TNF is believed to trigger joint inflammation -- but it also
helps combat infections.
As a result, TNF inhibitors may increase the risk of infection,
especially in elderly patients taking immune-system-suppressing
treatments for other conditions. Remicade has been associated with 84
cases of tuberculosis worldwide, including 14 fatal cases.
Along with strengthening the basic warning, the new label -- which was
devised in cooperation with the FDA -- will instruct physicians to
screen patients for tuberculosis and treat any such infections before
Remicade is prescribed.
The labeling revision also highlights the risk of various other
opportunistic infections, such as the serious lung infection
pneumocystis.
Centocor plans to send letters to healthcare professionals and create a
patient leaflet to help reinforce the new information. The company said
it would also continue to collect safety data on about 15,000 patients
to ensure that the labeling changes are sufficient.
Remicade has been prescribed to more than 170,000 patients since its
launch.
Immunex spokesperson Robin Shapiro said the company does not expect its
rheumatoid arthritis drug Enbrel to need a similarly strengthened
warning.
Last year, Enbrel's labeling was updated to include warnings about the
possibility of central nervous system disorders and pancytopenia, a drop
in the body's number of red and white blood cells.
Reuters August 15, 2001
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Dr. Joseph Mercola, eHealthy News You Can Use, August 29th,
2001 - Issue 250
Have Emphysema? Let's Cut Out
Some of Your Lung???
By Gina Kolata
A widely promoted lung operation for emphysema, so expensive that some
predicted it would bankrupt Medicare, did not help a group of the
sickest patients in a large, ongoing federal study.
The findings from the study will be published in The New England Journal
of Medicine on Oct. 11, but the journal made them public August 16
because its editors felt they were so important.
About two million Americans have emphysema.
The disease, almost always caused by smoking, destroys air sacs in the
lungs, leaving patients struggling for breath. Medical treatments offer
little relief.
But many surgeons have reported that the operation, which involves
removing as much as 30 percent of the lung, can greatly improve lung
function. Surgeons say the procedure works by removing damaged tissue
and giving the healthier parts of the lung more room to expand and
breathe.
The operation costs about $60,000.
It is not known how many patients have had the surgery, which came into
use in the early 1990's. In 1996, a government survey showed that more
than 3,000 had had the operation at 27 medical centers. There are no
national records of how many operations have been done since.
The new results are from 140 patients out of 1,033 who have enrolled in
the federal study and had their treatment assigned at random, either
surgery or medical treatment. The 140 patients, whose average age was
60, were so sick that their ability to force air out of their lungs was
no more than 20 percent of normal, and they had extensive lung damage.
Such severe illness means that a person might be able to walk around a
room, but could not walk half a block. Almost all needed supplemental
oxygen.
Sixty-nine of the 140 patients had the operation but had no improvement
in their quality of life.
Sixteen percent died in the month after the operation, as compared with
no deaths among study participants who were just as ill but did not have
the operation.
But even though the operation is still being studied, many surgeons are
selling it to patients because they believe it works. Unlike drugs or
medical devices, surgery is not regulated by the Food and Drug
Administration.
That means surgeons can offer new procedures without first proving that
they are safe and effective, Dr. Make said. It also means that when a
new operation seems promising, a market for it can spring up overnight.
That is what happened with the lung operation, medical experts said. By
the mid-1990's it had grown so popular that Medicare envisioned soon
paying for tens of thousands of operations a year.
But medical experts were concerned, because the positive reports were
from surgeons who did not did include, for comparison, a control group
of patients who were randomly assigned not to have the operation.
Such uncontrolled studies have often produced misleading results.
In 1996, the Centers for Medicare and Medicaid Services, which is
responsible for Medicare, and the National Heart, Lung and Blood
Institute agreed to begin a five-year national study that would include
such a control group.
And Medicare did something it had never done before. It said it would
pay for the experimental procedure only if patients joined the clinical
trial and agreed to be picked at random to have the operation or be in
the control group. The National Heart, Lung and Blood Institute insisted
that surgeons who were participating in the study not offer the
operation on the side to paying patients.
People with the worst emphysema have now been barred from the study, but
if the operation turns out to help most other participants, Medicare
could face a huge bill. About one out of three emphysema patients
qualifies for the federal study.
With two million emphysema patients in the country, most of Medicare
age, and at the discounted $30,000 price that Medicare pays for the
operation, it would cost $20 billion to operate on all who would be
eligible.
New York Times August 15, 2001
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Dr. Joseph Mercola, eHealthy News You Can Use, August 29th,
2001 - Issue 250
Drug Treatment of Vaginal Infections
Linked To Premature Delivery
Pregnant women should not be routinely screened
and treated for an infection that is associated with an increased risk
of preterm delivery, new study findings suggest.
In the study, pregnant women who received the drug metronidazole (Flagyl)
for a vaginal infection known as asymptomatic vaginal trichomoniasis,
were nearly twice as likely to deliver their babies early, compared with
women who received an inactive medication or placebo.
The investigators found that 19% of the women who received the drug
delivered their baby before 37 weeks' gestation.
Only 11% of the women who took the placebo experienced preterm delivery.
A full-term pregnancy is 40 weeks, but delivery anywhere from 38 weeks
to 42 weeks is considered safe.
Routine screening and treatment of symptomless pregnant women for this
condition cannot be recommended, the researchers concluded. The majority
of women who have vaginal trichomoniasis -- a sexually transmitted
infection -- do not have symptoms, which can include vaginal discharge
and burning.
Because the infection in pregnant women has been linked to an increased
risk of preterm delivery and low birth weight infants, screening and
treating the infection during pregnancy has been recommended, although
it was unclear whether the treatment reduced the risk of early delivery.
The New England Journal of Medicine August 16,
2001 ;345:487-493
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Dr. Joseph Mercola
eHealthy News You Can Use
Issue 196
February 21, 2001
Prevnar, Pneumococcal (Strep) Vaccine Does NOT Prevent
Ear Infections and Has Major Side Effects
Abstracted from lecture by Dr. Erdem Cantekin,
Ph.D. Professor of Otolaryngology at the University of Pittsburgh at the
Second International Vaccine Information Center Conference September 9,
2000; Washington D.C.
Prevnar is a new vaccine against pneumococcus. The alleged benefits are
greatly exaggerated and the risks are significant.
The least of the risks is the cost. This is the most expensive routine
vaccine to date. The wholesale cost is about $58.
There are over 90 different serotypes or (different strains based on
cell wall antigens) of pneumococcus. The vaccine only has 7 serotypes
assumed to be the common ones, but this is an uniformed experiment at
best as there is no way to know if this will be covering all of the
strains.
In the US pneumococcus causes the following:
3,000 cases of meningitis
50,000 cases of bacteremia
500,000 cases of pneumonia
7 million cases of ear infections
The FDA approval states the drugs is ONLY approved for invasive cases of
pneumococcal disease such as bacteremia and meningitis. It is NOT
approved for ear infections.
This is most peculiar as it is commonly recognized that bacterial
meningitis is primarily seen in adults not in infants for which this
vaccine is recommended.
The HMO trial in which Prevnar was approved had no placebo group. The
control group received another experimental vaccine for mennigococcus.
This was the ONLY trial that was done to establish the safety and
efficacy to recommend this vaccine for every newborn in the US.
There is an important concept known as serotype drift, which describes
the ability of the virus to actually shift and mutate. This phenomenon
is well documented in many HIV trials.
Well just how well did the vaccine work in the HMO trial? In the first
17 cases of bacteremia it worked perfectly.
However it was NOT effective for any cases of ear infections.
Ear infections are a BIG business in the US. It is estimated that 5
billion dollars a year are spent in treating ear infections.
If Prevnar could have stopped this or even reduced this problem it would
have been great. But that is not the case.
The FDA data from the HMO trial and that in Finland showed that the
prevention benefit is less than 4%.
The efficacy claims of Prevnar in ear infections and pneumonia remain
unproven.
What about adverse side effects of Prevnar?
The children who received Prevnar in the trial were
| 4 times more likely to have seizures
4 times more likely to have stomach problems |
Also, significantly more children developed asthma that had been given
Prevnar and there was also one death in the Prevnar group and none in
the other.
Prevnar also alters the developing immune system. Additionally it will
put selective pressure on the pneumococcal serotypes and has the
potential to change the natural pattern of strep infections.
Over one trillion dollars of health care system are under the watchful
eyes of the FDA, CDC and the NIH. These three pillars of our public
health care system have become to be more and more controlled by "expert
panels" advisory committees.
Such experts dictate policy and control the complex biomedical system.
They directly influenced taxpayers health and wealth.
However there is a huge conflict of interest as most of these experts
served the special interest groups who profit in their decision.
Many are in financial relationships with various manufacturers and are
registered as their paid speakers or as some
people might say paid
lobbyists
Back to the top
NEW YORK, Dec. , 2000
Anti-Flu Drug Under Scrutiny
CBS News Probe Obtains Reports Filed With FDA Respiratory Problems
Reported In 88 Cases By CBS News Correspondent Sharyl Attkisson
(CBS) A CBS News investigation has found the Food and Drug
Administration has received reports of 18 deaths of patients who were
taking the powder inhalant Relenza to combat the flu.
"Adverse event" reports filed with the FDA, the basis for stepped-up
warnings throughout the past year, have prompted some critics to
question whether Relenza's risks outweigh the benefits, reports CBS News
Correspondent Sharyl Attkisson.
When Relenza hit the market last flu season, it was aggressively
marketed by its maker Glaxo Wellcome Plc - Europe's second-largest drugmaker - as an exciting new treatment. The company claimed the
inhalant attacked a type of flu immune to older drugs.
The ads were flashy, but the medical claim was more modest - to get rid
of the flu one day faster.
Now with a new November-April flu season rapidly approaching, health
officials have been warning of serious, sporadic flu vaccine shortages.
That means more doctors and patients may be turning to prescription
drugs to treat the flu.
Each year, some 20 million Americans become ill with the flu; some
20,000 die from the flu or its complications.
More than a million people have tried Relenza, which was released onto
the market late last year. But as the drug's use has expanded, so have
complaints about dangerous side effects - especially breathing problems.
Respiratory problems were also noted in 70 other serious or
life-threatening cases reported to the FDA involving patients who took
Relenza. CBS News obtained copies of the "adverse event" reports by
filing Freedom of Information requests beginning last February
"If you're dealing with a drug and a disease that's very rare, you can't
do a large sample study because you don't have patients," said Janet Wittes, who was on the first FDA advisory committee to examine Relenza.
"But for flu? Flu is very common. You can do a very large study in not a
very expensive way. So part of the thinking for me was they could have
done the right study. They could have really gotten an assessment of
benefit. And they didn't."
Wittes said Glaxo Wellcome produced results from small foreign studies,
claiming that patients reported their flu symptoms were relieved a day
or two faster when they used Relenza. But Wittes said their relief was a
subjective and not a scientific measure and that flu symptoms usually
returned after the patient took the entire prescription.
Wittes also said that even a one-day benefit from the medication, as
claimed by Glaxo Wellcome, was a stretch. She said her committee voted
overwhelmingly not to allow it on the market, arguing that it did not
feel the manufacturer had proved it effective.
Some FDA scientists agreed, writing in internal documents obtained by
CBS News that Glaxo Wellcome "exaggerated" Relenza's benefits and that
it "has not been shown to be effective in this country ... and should
not be approved."
The FDA overruled the objections of other FDA scientists and the FDA
advisory committee's recommendation, instead rushing Relenza's approval
because there were no red flags about any significant health risks. The
FDA claimed even a small potential benefit could be of "substantial
public health importance."
But "adverse event" reports on Relenza quickly began piling up.
In January, the FDA issued a public health advisory urging "special
caution" for people with conditions like asthma. Three months later the
FDA ordered a stronger warning label emphasizing continuing reports of
breathing problems, noting "some...have had fatal outcomes." And in
July, the drug's maker sent a letter warning doctors about serious side
effects "in patients without a history of airways disease."
Wittes said that's the very reason Relenza should not have been put on
the market in the first place.
"To me, this confirms the importance of not approving a drug unless
there's really good evidence that it works," she said.
Glaxo Wellcome says "adverse event" reports are often complex and
incomplete, so it's impossible to know if theres' a direct link between
the drug and the deaths. Glaxo Wellcome declined to be interviewed.
Dr. Fred Hayden, a University of Virginia researcher who conducts paid
studies on Relenza and other drugs, said his research has proven
Relenza's effectiveness and that the drug may help patients recover even
faster than first thought.
"A one day reduction in (flu) misery, I think, is important to many
people," said Hayden, who said he could not address the drug's safety.
"Certainly, when one is talking about a two to three day reduction, as
has been seen in some of the studies with Relenza and other influenza
drugs, these are clinically meaningful benefits."
Hayden said Relenza also shows promise as a drug to prevent the flu, not
just treat it. Glaxo Wellcome hopes to soon win approval for preventive
use of Relenza. Ideally, the company would like the drug to be
prescribed to groups - such as students and nursing home patients -
where one person has developed the flu with Relenza used to help prevent
a wider outbreak.
But critics still warn of the potential side effects.
"One of the doctors on FDA's advisory committee ... who voted against (Relenza's)
approval said that he would never give this drug to people in his own
family," Consumer advocate Dr. Sidney Wolfe of Public Citizen told CBS
News. "That's something that people in this country should think about."
Nevertheless, FDA officials stand by their position that the drug is
safe and effective when the new label and warnings are followed, and has
now approved it for pediatric use.
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By LAURAN NEERGAARD
AP Medical Writer
WASHINGTON (AP) - Patients who take the powerful acne drug Accutane
will soon get special warning brochures outlining side effects -
including a possible, but not proven, link to suicide.
Patients must then sign a paper certifying they understand those
risks, health officials told Congress Tuesday.
The MedGuide warning brochures, attached to every bottle sold _ along
with tougher patient informed-consent forms _ may be distributed as
early as next month, said Dr. Jonca Bull, the Food and Drug
Administration's deputy drug chief.
Also, the FDA is developing tougher restrictions on who can take
Accutane and which doctors can prescribe it, Bull told the House
Government Reform Committee. This so-called registry is an attempt to
counter another Accutane problem: 2,000 women have gotten pregnant while
taking Accutane since the drug began selling in
1982. Accutane causes severe birth defects.
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Glaxo pulls controversial bowel drug
Latronex linked to serious side
effects, deaths
MSNBC NEWS SERVICES
Nov. 28 - The maker of a popular new treatment for
women's irritable bowel syndrome pulled the drug Lotronex off the market
Tuesday after it was linked to a growing number of deaths and
hospitalizations.
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By Don
Harkins
From the November 2000 Idaho Observer <http://www.proliberty.com/observer/20001108.htm>
Most people are by now aware that the artificial sweetener aspartame
becomes formaldehyde, a dangerous toxin for which neither the Food and
Drug Administration nor the Environmental Protection Agency has
identified a safe level of ingestion for humans. James Bowen, M.D., a
physician who has dedicated a tremendous amount of time and resources to
the study of aspartame, has identified the neurotoxin to be a catalyst
for polychemical hypersensitivity syndrome (PCS).
PCS is a condition that effects increasing
numbers of people who experience varying degrees of allergic reactions
to chemical exposure. According to Dr. Bowen, “The Persion Gulf Syndrome
is largely PCS from the massive NutraSweet [aspartame] exposure
experienced by our men in combat units in the Persian Gulf.” The
Pentagon has repeatedly denied such allegations since they claim that
PCS does not exist. The fact that nothing in orthodox medicine seems to
help soldiers stricken with Gulf War Illness (GWI) is an indication to
orthodox doctors that GWI symptoms are psychosomatic. “This illustrates
the highly significant feature of aspartame poisoning; that it is an
extreme hypersensitization agent which is highly reactive with other
chemicals -- especially toxic ones like the nerve gas and nitrogen
mustard gas to which our troops were exposed in the gulf when our
government tried to destroy the stockpiles of these gases they had
previously supplied to Saddam Hussein. This is a very poignant part of
the NutraSweet issue because those who had problems with NutraSweet will
now experience recurrences of those same problems when exposed to even
the most minute doses of various toxic agents,” explained Dr. Bowen. Dr.
Bowen's findings are supported by government studies regarding
formaldehyde sensitivity that were conducted many years ago. It was
found then that, once a person becomes hypersensitive to the toxin, he
can experience a violent physical reaction to a formaldehyde exposure of
as little as one billionth of a gram.
If Dr. Bowen's thesis is correct, the
millions of Americans who habitually drink sodas and eat foods
artificially sweetened with aspartame are not only vulnerable to the
entire menu of 92 aspartame-related complications <http://www.mercola.com/article/aspartame/symptoms.htm>
which range from impotence, hair loss, obesity and chronic irritability
to death, they are leaving themselves open to a lifetime of multiple
chemical sensitivity. “The reason I feel it's so important to
publish this information is that those who have been victimized by
aspartame really don't have a good shot at enjoying the health they had
before unless they recognize the problem and know how to deal with it,”
Dr. Bowen concluded.
The saddest joke on the American consumer is
that aspartame-sweetened sodas are marketed as “diet” soft drinks. The
truth is that aspartame suppresses the production of serotonin, which
makes them crave carbohydrates which, in turn, causes them to gain
weight.
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Dr. Joseph Mercola
eHealthy News You Can Use
Issue 264 </2001/oct/17/index.htm> October 17, 2001
Drug Companies Spend Two Billion to Advertise Directly
to Consumers
Magazine ads for prescription drugs are high on emotional appeal, but
short on evidence that they work. Urging consumers to help their
children fight allergies or to question whether their memory lapses
might be Alzheimer's, most drug ads favor "vague" claims over clinical
data.
Looking at ads in 70 issues of 10 leading US consumer magazines,
researchers found that 87% chose "vague, qualitative terms" to describe
the medication's benefits rather than providing research evidence.
These advertisements rarely quantify a
medication's expected benefit, and instead make an emotional appeal.
This strategy probably leaves many readers with the perception that the
drug's benefit is large and that everyone who uses the drug will enjoy
the benefit. The authors also argue that a key danger is that many of
these ads may "medicalize" run-of-the-mill problems in the public's
mind. A runny nose all of a sudden becomes allergic rhinitis.
The first direct-to-consumer advertisement
for a prescription drug appeared in Reader's Digest in 1981 in USA. Over
the next few years, other such advertisements were published, and the US
Food and Drugs Administration (FDA) became worried that little was known
about the potential effect of such advertisements on the public.
Consequently, in 1983, the FDA initiated an advertising moratorium while
it studied the issues and considered the regulatory options. Although
they concluded that "direct to the public prescription advertising was
not in the public interest," the FDA lifted the moratorium in 1985
because of concerns about freedom of speech and a general consensus that
regulations already in place were sufficient to protect the consumer.
After the moratorium had been lifted, direct- to-consumer advertising
was permitted provided that the advertisements met certain criteria;
specifically, that they presented true and balanced information about
the side-effects of the drugs, and their contraindications and
effectiveness. The FDA monitors compliance with these criteria. However,
prior approval of drug advertisements is not required.
Opponents of direct-to-consumer advertisements are worried that
direct-to-consumer advertisements might inappropriately increase patient
demand for specific, and generally costly, agents, and that this demand
might have a negative effect on medical practice and on the
physician-patient relationship.
Pharmaceutical companies spent $1.8 billion
on direct-to-consumer advertisements for prescription drugs in 1999.
Concurrently, many pharmaceutical companies have reduced the amount
spent on direct-to-physician advertising, which suggests a tactical
shift in their focus from physicians to patients. Last year, for
example, drug companies spent more on advertisements in newspapers and
popular magazines than they did in medical journals ($685 million vs
$473 million, respectively) (www.imshealth.com <http://www.imshealth.com>
accessed on Aug 25, 1999). Direct-to-consumer advertisements are common
in popular magazines, particularly in those aimed at women. Furthermore,
they all share a similar structure: they link the advertised product
with its target condition and invite consumers to share in their own
health management. Although most advertisements addressed the relief of
common symptoms that many consumers would normally treat themselves with
over-the-counter remedies (eg, runny nose), a substantial number
targeted more complex treatment decisions usually made by physicians (eg,
choice of antibiotic or type of insulin). Additionally, many of the
advertisements presented quantitative data about potential side-effects,
but very few provided any such data about benefit
In a nationally representative survey, two
thirds of adult Americans recalled seeing a prescription advertised, and
about 10% asked their doctor for that prescription (of these, 73% said
the prescription was made). Direct-to-consumer advertisements for
prescription drugs undoubtedly help to educate consumers about available
options. At the same time they encourage consumers to believe that a
problem might exist where they previously would not and that a
pharmacological solution is the appropriate way to deal with it.
The Lancet October 6, 2001;358:1141-1146
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Toxins in
the Environment
(AP) - New research
using rats suggests that long-term exposure to a widely used pesticide
kills brain cells and triggers debilitating physical symptoms associated
with Parkinson's disease. Scientists say the experiment's results
strongly indicate what scientists have suspected for several years -
that the most common form of Parkinson's disease might result from
toxins in the environment. Scientists who reviewed the experiment said
the results are powerful and should reinvigorate the search for
environmental toxins that may contribute to Parkinson's, the most common
neurological disorder after Alzheimer's. More than one million Americans
suffer from Parkinson's. Muscle control ebbs as brain cells in a region
called the substantia nigra produce less dopamine, a hormone vital to
normal nerve function. People most frequently would be exposed to
rotenone by ingesting residue in food or by handling the compound.
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Dr. Joseph Mercola, eHealthy News You
Can Use,
Issue 292 January 23, 2002
New Program
To Prevent Pregnancy In Accutane Users
Drug maker Hoffmann-La Roche on
January 7 began distributing to physicians and pharmacists updated
requirements aimed at preventing pregnancy in women who take the
company's acne drug Accutane.
Accutane is known to cause birth defects, and for 13 of the last 20
years the drug has been on the market, Roche has continually instituted
and revised restrictions on its use. Despite the company's efforts,
2,000 pregnancies occurred in women taking Accutane between 1982 and
2000, according to the Centers for Disease Control and Prevention.
Roche and the US Food and Drug Administration worked together to come up
with a new plan, and the System to Manage Accutane-Related
Teratogenicity (SMART) program was approved by the federal agency in
October.
Under SMART, which was mailed to 375,000 dermatologists, primary
physicians and pharmacists beginning Monday, female patients will now be
required to submit to a pregnancy test every month before receiving a
30-day refill of the medication. Before, the test was optional.
Also before receiving an initial prescription, women must have two
negative pregnancy tests, one as a screen and the second during the
first 5 days of the next menstrual period. They also must select and
commit to using two forms of birth control simultaneously for one month
before treatment, continue use during treatment, and for a month
afterwards.
Patients also have to read and sign an informed consent about the risk
of birth defects, and participate in the Accutane Survey, a
questionnaire about their use of the drug.
If a woman has complied with these criteria, the physician places a
yellow sticker on the paper prescription. The sticker acts as a
certification, and pharmacists will be warned to only fill prescriptions
with a sticker.
Women will not be allowed to request refills by phone--they must return
to the physician for the pregnancy test and certification.
Despite increasing numbers of prescriptions for Accutane, the numbers of
pregnancies were declining. About 550,000 prescriptions are written for
Accutane each year, and some 15 million have been issued since the drug
came on the market, she said.
Reuters January 8, 2001
DR. MERCOLA'S COMMENT:
Another example of a drug-based solution gone bad. This is especially
sad as changing one's eating choices seems to resolve most cases of
acne. Severe cases might require some additional, more sophisticated
natural medical therapies, but rarely, if ever is Accutane needed.
I have no problems with topical Retin A, which is most likely beneficial
and probably prevents and even reverses several types of skin cancers.
However, Accutane should be used with great caution and only if one has
not seen improvement with the eating plan and consulting with a natural
medical clinician.
In addition to Accutane, it would be best to avoid ALL medications, even
over-the-counter ones, if there is any chance of pregnancy. No drug has
been proven to be completely safe during pregnancy.
As I said in December when I reviewed the evidence that Accutane is also
associated depression and suicide:
Accutane is not the miracle cure-all for acne that it is promoted to be.
It has a category X for pregnancy which means that it causes birth
defects in nearly 100% of pregnant women.
The key to eliminating acne is to stop drinking soft drinks, juice, and
milk and to drink one quart of pure water for every fifty pounds of body
weight. It is also necessary to eliminate ALL sugar and chocolate. This
strategy works in the majority of people, but some have elevated
testosterone levels, which can promote acne.
In this case, non-synthetic vitamin A (the real McCoy-my favorite is
emulsified vitamin A from Biotics Research) is very helpful. It is
likely not toxic in pregnancy, but nonetheless should be avoided.
To be effective one must use a high dose of 100-200,000 IU per day. The
dose should not be used for longer than several months as toxicity could
be an issue (as detailed above) if taken much longer.
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