Natural Health News 2004 ArchivePain killers cause intestinal woes
Up to 70 percent of people using OTC and
Rx pain medications are subject to intestinal disorders leading to the use of
more drugs and OTC products to solve yet another problem.
Look at all of the drugs and OTC
products you are taking and consider the harm to your health that may be in the
making.
Don't forget that your health
care provider is required by law to tell you the risks and benefits of any drug
they prescribe.
If you are experiencing pain and
not getting relief, a short consultation with us may put you on a healthier
path. Contact us at
www.leaflady.org
BMJ 2005;330:7 (1 January),
doi:10.1136/bmj.330.7481.7
Jeanne Lenzer New York
The US Food and Drug
Administration has agreed to review confidential drug company documents that
went missing during a controversial product liability suit more than 10 years
ago. The documents appear to suggest a link between the drug fluoxetine
(Prozac), made by Eli Lilly, and suicide attempts and violence.
The missing documents, which were
sent to the BMJ by an anonymous source last month, include reviews and memos
indicating that Eli Lilly officials were aware in the 1980s that fluoxetine had
troubling side effects and sought to minimise their likely negative effect on
prescribing.
The documents received by the BMJ
reportedly went missing during the 1994 Wesbecker case that grew out of a
lawsuit filed on behalf of victims of a work-place shooting in 1989. Joseph
Wesbecker, armed with an AK-47, shot eight people dead and wounded another 12.
He then shot and killed himself. Mr Wesbecker, who had a long history of
depression, had been placed on fluoxetine one month before the shootings.
One of the internal company
documents, a report of 8 November 1988, entitled "Activation and Sedation in
Fluoxetine Clinical Trials," found that in clinical trials "38% of fluoxetine-treated
patients reported new activation but 19% of placebo-treated patients also
reported new activation yielding a difference of 19% attributable to fluoxetine."
The FDA recently issued a warning
that antidepressants can cause a cluster of "activating" or stimulating symptoms
such as agitation, panic attacks, insomnia, and aggressiveness. Dr Joseph
Glenmullen, a Harvard psychiatrist and author of The Antidepressant Solution,
published by Free Press, said it should come as little surprise that fluoxetine
might cause serious behavioural disturbances, as it is similar to cocaine in its
effects on serotonin.
Dr Richard Kapit, the FDA
clinical reviewer who approved fluoxetine, said he was not given the Lilly data.
"These data are very important. If this report was done by Lilly or for Lilly,
it was their responsibility to report it to us and to publish it."
Congressman Maurice Hinchey's
office is currently reviewing the documents to determine whether Lilly withheld
data from the public and the FDA. Mr Hinchey (Democrat, New York) said: "This is
an alarming study that should have been shared with the public and the FDA from
the get-go, not 16 years later. "
This case demonstrates the need
for Congress to mandate the complete disclosure of all clinical studies for
FDA-approved drugs so that patients and their doctors, not the drug companies,
decide whether the benefits of taking a certain medicine outweigh the risks."
The plaintiffs in the Wesbecker
product liability sought to show that Eli Lilly withheld negative study data
from the FDA and that fluoxetine tipped Wesbecker over into a homicidal rage.
Lilly won a 9 to 3 jury verdict in late 1994 and subsequently claimed that it
was "proven in a court of law... that Prozac is safe and effective."
The trial judge, Justice John
Potter, suspecting that a secret deal had been struck, pursued Lilly and the
plaintiffs, eventually forcing Lilly in 1997 to admit that it had made a secret
settlement with the plaintiffs during the trial. Infuriated by Lilly's actions,
Judge Potter ordered the finding changed from a verdict in Lilly's favour to one
of "dismissed as settled with prejudice," saying, "Lilly sought to buy not just
the verdict but the court's judgment as well."
David Graham, currently associate
director in the FDA's Office of Drug Safety, criticised the analysis of
post-marketing surveillance data submitted by Lilly to the FDA. After
discovering that Lilly failed to obtain systematic assessments of violence and
had excluded 76 of 97 cases of reported suicidality, Dr Graham concluded in a
memo dated 11 September 1990 that "because of apparent large-scale
underreporting, [Lilly's] analysis cannot be considered as proving that
fluoxetine and violent behavior are unrelated."
Congressman Maurice Hinchey said
that the internal Lilly data "should have been shared with the public"
An FDA advisory panel was
convened in 1991 to review the fluoxetine data. It concluded that fluoxetine was
safe despite the concerns raised by Dr Graham and others, leading critics to
point out that several of the panellists had financial ties to Eli Lilly.
Dr Glenmullen said the missing
documents obtained by the BMJ provide "the missing link" between the recent
advisory issued by the FDA and what Lilly scientists knew 16 years ago.
Since the 1991 FDA hearings Dr
Peter Breggin, who served as the medical expert in the Wesbecker case, has
warned that the stimulant effects of fluoxetine can cause suicide and violence.
He cautions that the 38% activation rate reported in the missing document is
probably low because "it doesn't include other symptoms of activation such as
panic attacks, hypomania, and mania."
Dr Kapit, the original reviewer
for fluoxetine, told the BMJ, "If we have good evidence that we were misled and
data were withheld then I would change my mind [about the safety of fluoxetine].
I do agree now that these stimulatory side effects, especially in regards to
suicidal ideation and homicidal ideation, are worse than I thought at the time
that I reviewed the drug."
Lilly declined to be interviewed
but issued a written statement saying, "Prozac has helped to significantly
improve millions of lives. It is one of the most studied drugs in the history of
medicine, and has been prescribed for more than 50 million people worldwide. The
safety and efficacy of Prozac is well studied, well documented, and well
established."
Dr. Edmund Tramont, director of the
National Institute of Allergy and Infectious Disease Division of AIDS, altered
the conclusions from a safety report on pregnant women taking the drug
nevirapine in order to cover up its negative side effects.
Since the mid-1990s, nevirapine, an antiretroviral drug, has been used despite
government warnings that it could cause deadly liver problems or rashes when
multiple doses were administered over time.
A study in 2002 was conducted to evaluate whether or not nevirapine could
possibly decrease the risk of mother-to-child HIV transmission.
Multiple Problems With Drug Research
Medical safety experts, an NIH auditor and the manufacturer of the drug agreed
that there were various faults discovered within the study. Some of these faults
included giving improper doses to study participants and neglecting to report
specific fatal and detrimental reactions to the drug.
A report compiled by a medical officer under Tramont, Dr. Betsy Smith, revealed
that the research lacked in safety reporting. Smith also reported that the
records kept of the patients failed to meet the standard level of clinical
research.
Tramont Puts Positive Spin on Drug Reports
Tramont requested to review the report before it was passed on to the FDA.
Interestingly enough, after his review the report showed very different
recommendations, none of which included any of Smith's prior recommendations.
Tramont's revised recommendations reported that any negative reactions regarding
the drug use were not of importance in assessing the safety of the drug.
Tramont also claimed he wrote the report after the inquiry into the changes in
Smith's report.
The family of Joyce Ann Hafford paid the ultimate price for the negligence of
the drug nevaprine -- her life. Despite the signs of liver failure, Hafford's
doctors continued to give her the experimental drug nevaprine throughout her
pregnancy as an attempt to save her unborn son from contracting AIDS.
It was only after the family received copies of NIH's internal case documents
from the Associated Press that they realized the experimental drug regimen was
the likely cause of Hafford's death.
See archives for earlier post on
Hafford.
"I had only a sprained ankle but 4 days
later a flesh-eating bug started devouring my body."
Police inspector Nigel Shambler,
37, developed a flesh-eating bacteria,resulting in amputation, after attending
hospital for a sprained ankle. The hospital told him to take Ibuprofen.
Nigel writes "In fact, taking
IBUPROFEN MAY HAVE EXACERBATED THE SITUATION. I learnt later that experts
believe there may be a link between the bug & common painkilling drugs such as
Ibuprofen that dampen the immune system, allowing the bacteria to fluorish."
(Edward Priestley, who studies
medical reference books, says that around 200 prescribed medical drugs which are
based on benzene-related molecules, are listed as causing bone marrow damage or
serious blood disorders, resulting in immune system depletion.)
Families Of Slain GIs Raise$600k For
Fallujah Refugees
Agence France Presse12-24-4
LOS ANGELES -- Families of US
troops killed in the offensive on the Iraqi city of Fallujah are to travel to
Jordan next week with 600,000 dollars worth of humanitarian aid for refugees of
the attack.
The November assault on Fallujah
left 71 US military dead, according to the families, and the Iraqi government
said more than 2,000 Iraqis were killed.
"This delegation is a way for me
to express my sympathy and support for the Iraqi people," said Rosa Suarez of
Escondido in California.
"The Iraq war took away my son's
life, and it has taken away the lives of so many innocent Iraqis. It is time to
stop the killing and to help the children of Iraq," she added in a statement
released by the families.
The families said with peace
groups, physicians' organisations and relatives of the September 11, 2001
attacks victims, they raised 100,000 dollars in an internet appeal. Humanitarian
groups such as Middle East Children's Alliance and Operation USA contributed
500,000 dollars worth of medical supplies.
The families are to fly to Amman
on December 26 and hand over the supplies to humanitarian and medical workers
there.
By David Stauth, 541-737-0787
SOURCES: Fred Stevens,
541-737-9534, Balz Frei, 541-737-5078
CORVALLIS – Researchers in the
Linus Pauling Institute at Oregon State University have made a major discovery
about the way vitamin C functions in the human body – a breakthrough that may
help explain its possible value in preventing cancer and heart disease.
The study, which explores the role of vitamin C in dealing with the toxins that
result from fat metabolism, was just published in a professional journal,
Proceedings of the National Academy of Sciences.
It contradicts the conclusions of some research that was widely publicized three
years ago, which had suggested that this essential nutrient might actually have
toxic effects.
The new OSU study confirmed some of the results of that earlier laboratory
study, which had found vitamin C to be involved in the formation of compounds
potentially damaging to DNA. But that research, scientists say, only provided
part of the story about what actually happens in the human body.
The newest findings explain for the first time how vitamin C can react with and
neutralize the toxic byproducts of human fat metabolism.
“This is a previously unrecognized function for vitamin C in the human body,”
said Fred Stevens, an assistant professor in the Linus Pauling Institute. “We
knew that vitamin C is an antioxidant that can help neutralize free radicals.
But the new discovery indicates it has a complex protective role against toxic
compounds formed from oxidized lipids, preventing the genetic damage or
inflammation they can cause.”
Some earlier studies done in another laboratory had exposed oxidized lipids –
which essentially are rancid fats – to vitamin C, and found some reaction
products that can cause DNA damage. These test tube studies suggested that
vitamin C could actually form “genotoxins” that damage genes and DNA, the types
of biological mutations that can precede cancer.
But that study, while valid, does not tell the whole story, the OSU researchers
say.
“It’s true that vitamin C does react with oxidized lipids to form potential
genotoxins,” said Balz Frei, professor and director of the Linus Pauling
Institute, and co-author on this study. “But the process does not stop there. We
found in human studies that the remaining vitamin C in the body continues to
react with these toxins to form conjugates - different types of molecules with a
covalent bond - that appear to be harmless.”
In human tests, the OSU scientists found in blood plasma extraordinarily high
levels of these conjugates, which show this protective effect of vitamin C
against toxic lipids.
“Prior to this, we never knew what indicators to look for that would demonstrate
the protective role of vitamin C against oxidized lipids,” Stevens said. “Now
that we see them, it becomes very clear how vitamin C can provide a protective
role against these oxidized lipids and the toxins derived from them. And this
isn’t just test tube chemistry, this is the way our bodies work.
“This discovery of a new class of lipid metabolites could be very important in
our understanding of this vitamin and the metabolic role it plays,” Stevens
said. “This appears to be a major pathway by which the body can get rid of the
toxic byproducts of fat metabolism, and it clearly could relate to cancer
prevention.”
Oxidation of lipids has been the focus of considerable research in recent years,
the scientists say, not just for the role it may play in cancer but also in
other chronic diseases such as heart disease, Alzheimer’s disease, and
autoimmune disorders.
The toxic products produced by fat oxidation may not only be relevant to genetic
damage and cancer, researchers believe, but are also very reactive compounds
that damage proteins. For instance, there’s a protein in LDL, the “bad”
cholesterol in your blood, which if damaged by toxic lipids can increase the
chance of atherosclerotic lesions.
In continuing research, the OSU team plans to study the role of this newly
understood reaction between vitamin C and toxic lipids in atherosclerosis. In
clinical studies they plan to examine the blood chemistry of patients who have
been diagnosed with coronary artery disease, compared to a healthy control
group.
“In the early stages of atherosclerosis, it appears that some of these toxic
lipids make white blood cells stick to the arterial wall, and start an
inflammatory process that ultimately can lead to heart disease or stroke,” Frei
said. “When we better understand that process and the role that micronutrients
such as vitamin C play in it, there may be strategies we can suggest to prevent
this from happening.”
The new findings, the OSU scientists say, also point to new biomarkers that can
be useful in identifying oxidative stress in the human body. They may provide an
indicator of people who may be at special risk of chronic disease.
Micronutrient Research for
Optimum Health
Linus Pauling Institute Oregon State University571 Weniger Hall Corvallis, OR
97331-6512phone: 541-737-5075 fax: 541-737-5077 email:
lpi@oregonstate.edu
Potential Depletion Problems from
Ibuprofen, Naproxen, Sulindac, Piroxicam, Diclofenac, Diflunisal,
Etodolac,Fenoprofen, Ketoprofen, Ketorolac, Meclofenamate, Nabumetone, Tolmetin,
Mefenamic Acid*, Celecoxib**, Indomethacin***
Folic acid depleted: may cause
anemia, birth defects,cardiovascular disease, cervical dysplasia,brittle nails,
fatigue, hair loss, weakness.
NSAIDs are taken for inflammatory
and rheumatoid disorders, fever and pain. A sampling of the brand names
available includes *Aleve, Motrin and Relafen;**Celebrex ;*** Indochron E-R and
Indocin.
The scientific basis for this
information is published from studies using these drugs or drugs from the same
pharmacological class.
Advise clients to ask their
doctor or pharmacist if any of their medications can cause nutrient depletions.
Reprinted with permission from
Drug-Induced Nutrient Depletion Handbook (Lexi-Comp, 1999) by
Ross Pelton, Ph.D., C.N.; James B. LaValle, N.D., C.N., D.H.M.; Ernest B.
Hawkins and Daniel L. Krinsky.
Your government at work: FDA does it
again!
The
antiviral combination drugs Nevirapine (Viramune) and Combivir causes death from
liver failure. FDA knew since 2002 that Viramune was potentially a cause of
liver failure.
Read more...
After 60 year of failed policies on
water fluoridation, things seem finally to be seeping into the open. Complaints
of increased bone density, tooth decay and gum problems; heart, kidney, stomach
and liver problems; sleep, mood and behavioral problems; cancer, bone density,
and undiagnosable aches and pains have all resulted from water fluoridation.
More problems are associated with glandular disturbances (mainly the thyroid)
than ever before, and diabetes along with obesity is on the rise. Fluoride
compounds in drugs like Fen-Phen, antibiotics and anti-depressants contribute to
heart problems (valve and heart beat irregularities), super-infection, suicide
and addictive behaviors.
For what you really need to know
about fluoride please go to
PFPC
So you think it can't effect you, right?
So if that is the case then why did ten top scientists leave there jobs to start
the
Radiation and Public
Health Project?
This group has published numerous books on the effects of low level radiation (LLR).
And so what is LLR? How about your wireless antenna, cell phone, microwave oven,
and all those kitchy little gadgets the marketing maniacs convince you can't
live without...
And what about the effects of pollution and the lung-clogging particulates. Ever
guess that these fine particle are ionised by LLR and it makes them stick like
glue to the lining of your lungs. Asthma increasing in your city these days?
The high frequency microwaves, low ELF waves at pulsed frequencies and known to
effect physical and mental capacities in humans and animals. This same effect
applies to viruses, bacteria, fungi, mycoplasma, blood cells, and more so that
the impact can be observed. An experiment by any other name is still an
experiment. When did you give permission to be a guinea pig?
See the
X-Rays and Health Project
too.
CVS is first
customer for American Express national ExpressPay program. All 5300
stores, in 2005, will be set up to take all your personal data so you can engage
in "cashless" transactions.
Is the convenience worth the violation of your privacy?
See more on this topic at
STOPRFID
Dr. David Graham is the FDA researcher who tore his bosses
to shreds over VIOXX, dangers of other drugs, and the FDA drug approval process.
http://www.forbes.com/home/sciencesandmedicine/2004/12/13/cx_mh_1213faceoftheyear
See
www.supplementinfo.org
for this important story.
Mainstream medicine sold out in the
1960s to the insurance companies. As a result, physician prescriptions can be
changed by some one else, w/o permission from or even knowledge by the
prescribing physician.
Pharmaceutical Benefit Management
(PBM) companies started up about this time and became the agencies for allegedly
controlling HMO drug costs.
Drug companies soon started
buying out the PBMs, and became able to control the use of their drugs and
getting money for it. All in the name of cost containment?
This is not about using generics,
but what the system became. It is all about money of course through substitution
of one drug for another. The substituted drug may be completely different than
the one initially prescribed by the doctor.
Research has shown that -
especially in HMOs - the drug received by the patient is not the one prescribed
or desired by the patient's doctor. Pharmacists are targeted to get $ if they
persuade the doctor to change to certain drugs manufactured by the drug company
controlling the PBM.
Eli Lilly, Merck and Smith-Kline
Beecham bought up the three largest PBMs for something in the range of $10
billion.
Do you see a connection with the
new prescription cards for Medicare, or those promoted by individual
pharmaceutical companies to people without insurance?
Ever wonder why all the pressure
is put on trial lawyers in the name of controlling health costs ?
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