From: john on 3 Mar 2010 02:17
Glaxo Knew Avandia Caused Heart Risk, Report Says (Update1)
By Rob Waters
Feb. 20 (Bloomberg) -- Safety reviewers at the U.S. Food and Drug
Administration urged the agency to take GlaxoSmithKline Plc�s diabetes drug
Avandia off the market in 2008 because they said it was causing 500
additional heart attacks per month. Two U.S. senators say they want to know
why the medicine remains on pharmacy shelves.
A report released today by Senators Max Baucus and Charles Grassley said
Glaxo knew Avandia may cause heart damage several years before a study
documented the risk and the company pressed doctors to retract warnings
about side effects. Baucus, chair of the Senate Finance Committee, and
Grassley, the committee�s ranking Republican, are pressing the FDA for
Avandia came on the market in 1999 and achieved annual revenue of $3 billion
by 2006, including sales of a combination drug that includes Avandia. Sales
plummeted to $1.2 billion in 2009, two years after a study was published in
the New England Journal of Medicine that linked Avandia to a 43 percent
increased risk of heart attack. Two FDA officials also reviewed the drug�s
safety and concluded in their 2008 report that Avandia was exposing users to
higher risks for heart attacks, or myocardial infarctions, without being any
more effective than a rival drug, Tokyo-based Takeda Pharmaceutical Co.�s
�These increased risks have caused a substantial excess of acute myocardial
infarctions and heart failure that would not have occurred� had Actos been
used instead, wrote David Graham and Kate Gelperin, the two FDA officials,
in the report. Avandia �should be removed from the market.�
Glaxo, in a statement e-mailed today by Mary Anne Rhyne, a company
spokeswoman, said it rejects conclusions that Avandia is risky for patients.
�The scientific evidence simply does not establish that Avandia increases
ischemic cardiovascular risk or causes myocardial ischemic events,� she
�The FDA considered all the available scientific evidence on Avandia,
including Dr. Graham�s assertions of elevated heart attack risk and demands
that the product be withdrawn,� the statement said. �Based on the scientific
evidence and a recommendation by an independent advisory committee of
experts convened by the FDA, the agency has ruled that Avandia remain
available to patients for the treatment of Type 2 diabetes.�
Karen Riley, an FDA spokeswoman, said in an e-mail that the agency is
�reviewing the report from the senators, we take it very seriously and we
will reply quickly.�
In the 2008 report, the FDA safety officers also said that a medical trial
comparing Avandia with Actos that was being planned would be �unethical and
exploitive� because it would expose patients to unwarranted risks. That
trial, called TIDE, which was planned to involve 16,000 patients, is now
Baucus, a Montana Democrat, and Grassley, an Iowa Republican, sent a letter
Feb. 18 to FDA Commissioner Margaret Hamburg asking what steps the agency
was taking to protect patients in the TIDE trial and demanded a response to
their concerns by March 4.
Today�s Senate committee report said executives of London- based Glaxo
obtained a copy of the 2007 New England Journal study in advance of its
publication from a company consultant who also worked as a reviewer for the
journal. Although company scientists internally recognized the study�s
validity and acknowledged Avandia�s heart risks, Glaxo prepared a public
relations effort to refute suggestions that the drug triggered heart
attacks, according to internal e-mails reviewed by Senate researchers cited
in the report.
�It can be argued that GSK had a duty to warn patients and the FDA of the
Company�s concerns,� wrote Baucus and Grassley in the Senate committee
report. �Instead, GlaxoSmithKline executives attempted to intimidate
independent physicians, focused on strategies to minimize or misrepresent
findings that Avandia may increase cardiovascular risk, and sought ways to
downplay findings that a competing drug might reduce cardiovascular risk.�
The risks were described in today�s New York Times in a story based on the
Senate report and other documents.
Glaxo pressed medical researchers who observed the emergence of heart and
liver problems in patients taking Avandia to stop disseminating their
findings, contacting the doctors� superiors in several cases, according to
Glaxo fell 58 cents, or 1.5 percent, to $38.26 in New York Stock Exchange
composite trading yesterday. The stock is up 18 percent in the past 12
Sales of Actos, Takeda�s competing drug, were $4.4 billion for the year
ended March 2009.
To contact the reporter on this story: Rob Waters in San Francisco at
Last Updated: February 20, 2010 16:36 EST
From: Happy Oyster on 3 Mar 2010 10:52
On Wed, 3 Mar 2010 07:17:15 -0000, "john" <nospam(a)bt.com> wrote:
>Glaxo Knew Avandia Caused Heart Risk, Report Says (Update1)
But this still does not make homeopathy work.
Homneopathic is criminal bullshit and fraud.
Die volle H�rte: http://www.kindersprechstunde.at
Die Medienmafia � Die Regividerm-Verschw�rung
From: mainframetech on 6 Mar 2010 15:46
On Mar 3, 10:52 am, Happy Oyster <happy.oys...(a)ariplex.com> wrote:
> On Wed, 3 Mar 2010 07:17:15 -0000, "john" <nos...(a)bt.com> wrote:
> >Glaxo Knew Avandia Caused Heart Risk, Report Says (Update1)
> But this still does not make homeopathy work.
> Homneopathic is criminal bullshit and fraud.
> Die volle Härte:http://www.kindersprechstunde.at
> Die Medienmafia » Die Regividerm-Verschwörunghttp://www.transgallaxys..com/~kanzlerzwo/showtopic.php?threadid=5710
LOL! From your position at the top of the pyramid of wisdom I hear a
If Homeopathic were nothing more than the 'Placebo Effect', why
then it works. Placebos have been shown to work sometimes better than
test drugs in double blind studies.
From: Happy Oyster on 6 Mar 2010 15:16
On Sat, 6 Mar 2010 12:46:31 -0800 (PST), mainframetech <mainframetech(a)yahoo.com>
> If Homeopathic were nothing more than the 'Placebo Effect', why
>then it works.
"IF". But it does not work.
Die volle H�rte: http://www.kindersprechstunde.at
Die Medienmafia � Die Regividerm-Verschw�rung
From: Jan Drew on 6 Mar 2010 23:15
On Mar 6, 3:16ï¿½pm, Happy Oyster <happy.oys...(a)ariplex.com> wrote:
> On Sat, 6 Mar 2010 12:46:31 -0800 (PST), mainframetech <mainframet...(a)yahoo.com>
> > ï¿½ If Homeopathic were nothing more than the 'Placebo Effect', why
> >then it works.
> "IF". But it does not work.
Homeopaths point to the nearly two hundred years of clinical
experience of convinced doctors and satisfied patients. Homeopathic
remedies are believed to be effective in treating a wide variety of
illnesses: infectious diseases such as flu and colds; chronic
conditions such as allergies, asthma, migraines, and PMS. Conventional
medicine has not had much of success in treating many of these
Several clinical studies exist that show the effectiveness of
homeopathic remedies. Many of these studies employed double blind
studies, accepted by scientists. Recent clinical trials suggest that
homeopathic medicines have a positive effect on allergic rhinitis,
asthma, treatment of dermatological complaints, fibrositis, influenza,
and for the treatment of migraine.
In 1994, the first study that involved homeopathy was published in a
peer-reviewed American scientific journal. Jennifer Jacobs, M.D., led
the study, which was conducted in Nicaragua and included eighty-one
children with acute diarrhea. All the children received standard
antidehydration treatment for diarrhea, consisting of water containing
salt and sugar. In addition, half the children received homeopathic
treatment and half received a placebo. The study confirmed
homeopathy's effectiveness: the recovery time for children receiving
homeopathic treatment was 20 percent faster than those receiving the
placebo, reducing the bout of diarrhea by one day. These results are
heartening because diarrhea is the leading cause of death in
developing countries such as Nicaragua.
In 1991, the British Medical Journal published an analysis of 107
clinical studies published between 1966 and 1990. The authors found
that in 81 of the experiments, the homeopathic treatments were
successful. Even when they included only the 23 studies that they
considered to be of the highest quality, the vast majority of these
(15) showed positive results. Here's how the results broke down: 13
out of the 19 trials of respiratory infection treatment were
effective, 6 out of 7 were positive for other infections, 5 out of 7
were positive for digestive system treatment, 5 out of 5 were
successful for hay fever, 5 out of 7 showed accelerated recovery after
surgery, 4 out of 6 helped in rheumatological disease, 18 of 20 were
beneficial for pain or traumatic injury; and 8 out of 10 worked for
mental or psychological problems.
In one study published in Lancet by Dr. David Taylor Reilly and his
colleagues compared the effects of a homeopathic hay-fever remedy with
a placebo. In this double-blind controlled study, Dr. Reilly found
that those who received the homeopathic remedy had six times fewer
symptoms and were able to cut their use of antihistamines in half.
Another study published in 1989 in the British Medical Journal dealt
with fibromyalgia. The double- blind, controlled trial was also
"crossed over," meaning the treatment lots were switched after one
month so the subjects could be compared, not only with each other, but
also with themselves. The results were evaluated by a rheumatology
professional who was not a homeopath. The study found that the
homeopathic remedy provided highly statistically significant
improvement in both subjective and objective symptoms.
In a double-blind controlled study conducted in Britain in 1980, 82
percent of those receiving the homeopathic remedy enjoyed improvements
in rheumatoid arthritis versus 21 percent of the control group on
placebo. The subjects in this study received remedies that were
Other significant positive studies show homeopathy helps in pain
following tooth extraction (76 percent versus 40 percent for a
placebo}; reduces vertigo and nausea; reduces labor time in pregnant
women (5.1 hours versus 8.5 hours}; and reduces risk of abnormal labor
(11.3 percent versus 40 percent).
Two double-blind studies compared Quietude, a combination of
homeopathically prepared plant extracts that has been very popular in
France, with diazepam (Valium). The subjects were adults and children
who were nervous and suffered from sleeplessness. The results showed
that the homeopathic product increased sleep time, reduced
interruptions during sleep, and reduced nervousness. Both products
relieved insomnia and minor nervous tension 63 percent of the time.
However, the homeopathic remedy produced no side effects: there was no
daytime dizziness, as opposed to 13 percent of the diazepam group.
Homeopathic remedy group suffered no daytime drowsiness, but 53
percent of the diazepam group felt drowsy. In addition, Quietude was
better at reducing children's nightmares, and 74 percent of the
Quietude patients said the product was better than other treatments,
as opposed to 48 percent of the diazepam group who felt this way.
A study, conducted in 1985, found that patients who took the
homeopathic product Oscillococcinum, derived from duck heart and
liver, experienced reduction in their fever much rapidly (in two
days ) than those who took placebo. Shivering disappeared by day four.
In another controlled study, published in 1989 in the British Journal
of Clinical Pharmacology, 66 percent more of the Oscillococcinum group
recovered within forty-eight hours as compared to the placebo group.
Clinical studies show the effectiveness of homeopathic remedies in
treating infectious diseases. In a French study published in 1987,
silica, prepared homeopathically to the 10c potency, stimulated
macrophage activity by nearly 70 percent. Macrophages are white cells
belonging to the immune defense system that destroy harmful cells and
microorganisms. Homeopathic remedies were also shown to be effective
in correcting immunological disorders in mice. In other studies, eight
out of ten homeopathic remedies tested were able to inhibit the growth
of viruses (in chicken embryos) by 50 to 100 percent.
Other studies show the usefulness of homeopathic remedies in treating
diabetes. A 1992 study examined sixty people with retinal problems due
to diabetes. In approximately half of the patients taking the
homeopathic remedy (Arnica), the eye condition improved; only 1
percent of the subjects receiving placebo improved a like amount. The
subjects were evaluated using objective measuring instruments,
indicating that homeopathy may prove valuable in helping this group of
diabetics preserve their sight.
Conventional physicians often belittle homeopathic remedies and their
effectiveness to placebo effect. However, several studies on animals
and infants show that homeopathic remedies do work. Obviously, animals
and infants are less likely to be influenced by placebo. In Germany,
poultry farmers are treating their hens with homeopathic remedies
instead of antibiotics for coughs, colds, and digestive problems.
Farmers also treat their cats, dogs, horses, cattle, and birds
Other animal studies add to the evidence. A 3x potency of Chelidonium
lowered cholesterol in rabbits by 25 percent. Microdoses of Arsenicum
(10x up to 30x; and 5c up to 15c) helped rats eliminate toxic doses of
arsenic from their systems, a study that has important implications
for humans who are increasingly exposed to many heavy metals in the
environment. And pigs given Caulophyllum had half as many stillbirths
as those who received a placebo.
Homeopaths have been reporting good results when treating infants for
common health problems such as teething, colic, eczema, and fever.