Senate Hearing: Medical Errors Are Third Leading Cause of Death???

medical errors

Third Leading Cause of Death – Medical Errors

and When You Add In Medications How High Is The Toll Really?

July 17, 2014 the US Senate Committee on Health, Education, Labor, & Pensions held a hearing on the number of deaths caused by preventable medical errors.

http://www.sanders.senate.gov/newsroom/medical-mistakes

C-SPAN has a video of those Senate hearings posted here… http://www.help.senate.gov/hearings/hearing/

But before going to those links if you will go to our website to read our mission statement at http://www.drugawareness.org/mission/ you will see how long this situation has been going on and find a link to a study done by pharmacists who were tired of seeing patients die from the drugs they were handing out. They found that the Third Leading Cause of Death in America is “properly prescribed prescription drugs” (prescribed according to what the FDA has judged to be “safe and effective”.) This is a study done in 1995 so you can imagine how much worse it would be by now. If you add that together with these deaths plus add in the medication-induced heart attacks and medication-induced cancer and medication-induced suicides you will find medical treatment to be the leading cause of death in America!

To all that add to it the warning from Dr. John Ioannidis, the world’s leading expert on medical research, who says that 90% of medical research is now tainted or just plain bogus and that he fears that medical science will not be able to survive this. http://www.drugawareness.org/recentcasesblog/lies-damned-lies-and-medical-science

From all this information the lesson seems clear…Keep your loved ones away from doctors and nurses and their treatments!!!

Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org & http://ssristories.drugawareness.org
Author: ”Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

WITHDRAWAL HELP: You can find the hour and a half long CD on safe and effective withdrawal helps here: http://store.drugawareness.org/ And if you need additional consultations with Ann Blake-Tracy, you can book one at www.drugawareness.org or sign up for one of the memberships for the International Coalition for Drug Awareness which includes free consultations as one of the benefits of that particular membership plan.

WITHDRAWAL WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

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PROZAC: Worsening Depression & Panic Attacks: England

Paragraph twelve reads: “The next day was a Friday and I started taking
the Prozac extremely reluctantly. The side effects listed on the pack
included headaches, dizziness, diarrhoea, nausea, vomiting, abdominal pains, dry
mouth, loss of appetite, anxiety, sleeplessness, nervousness. If I am
anxious now, I thought, how anxious will I be on Prozac? If I wake at four each
morning now, and toss and turn for many of the hours that follow, will I get
any sleep on Prozac?”

Paragraph fourteen reads: “By Monday I could not move. I felt sick, heavy
as a rock, everything ached, and my head swam. I had the pains and sort of
breathlessness associated with heart attacks and I was, of course, crying.
I rang work to say I had some sort of bug and that I hoped to be right the
next day. Speaking was an effort. It was hard convincing myself that the
advantages to leaving the house and seeing the doctor outweighed those of
staying inside where I wanted, desperately, to be, but I knew I needed to
seek advice. Dr Fahey offered, again, to sign me off work; my response, again,
was an adamant no. I was going into work as soon as I could.”

Paragraph 20 reads: “After the second visit to Dr Fahey everything
changed. She made me realise that whatever self-deceptions I had entered into,
the reality was that I had not been into work for several days, nor was I
currently fit to go in. She signed me off for two weeks and gave me
tranquillisers to moderate the increasingly severe panic attacks. She advised me
strongly to leave London. The idea of being on my own without work for two weeks
was unthinkable, unbearable. Amanda was off to visit our parents in the
country and taking the children with her. My brother-in-law Neil was staying
at home an extra night then would join her there. Amanda’s suggestion was
that I drive to be with Neil and then the following day he would drive us
both to Suffolk to be with the whole family.”

http://www.guardian.co.uk/lifeandstyle/2010/apr/18/depression-and-recovery-c
amilla-nicholls

Woman on the verge
She was a media executive at the top of her game. But a debilitating
midlife crisis forced Camilla Nicholls to hit rock bottom. In a searingly honest
account, she details her nervous breakdown – and her tentative steps back
to recovery

It all started slipping away from me in July 2000. Depression had been
part of my life for a long time, but that summer it ceased to be under
control. It was shortly after a married friend’s party that I had the first
significant “What is the point?” conversation.

Every guest had brought with them a child, or a swelling stomach. Hardly a
conversation was had at head height; we were all dipping and bending or
squatting to catch half a sentence with someone too heavy to stand for long.
There was no chance of eating as little hands pawed at the snacks, and
pregnant women, picking through the non-pasteurised, took precedence around the
table. Sentences were left hanging in the air as parents attended to
toddlers’ or babies’ urgent needs.

My friends will bear testimony that I am very fond of children. But I was
bitter because, aged 39, I had no partner, no prospect of a partner and,
more significantly, no prospect of motherhood. Maybe the party felt harder to
cope with that day because my hopes had just taken a severe knock. I had
been told by an unsentimental doctor’s receptionist that I was
peri-menopausal (ie approaching the menopause) and the possibility of my bearing
children was lodged somewhere between zero and infinitesimal.

The “what is the point?” conversation is the one for friends and family to
look out for as a first clue to depression. This is not the “what is the
point?” response of a child to doing homework or cleaning a bedroom; it is,
rather, “what is the point of my being alive?” For depressives the feeling
is often heightened when the reasons for depression are not obvious to
themselves or, more importantly, to others. This leads to the cajoling (or
worse, hectoring) question: “What have you got to be depressed about – you have
a great job/partner/house/body?”

I come from a small, loving, middle-class family. I was not brought up to
follow a particular religion, although as a child my grandmothers took me,
and my only sister Amanda, to Sunday services at the local church in the
Surrey town where we spent all our youth. What my parents did adhere to with
near religious fervour was the observation of good manners. A framework of
politeness in all situations was my firmest mould. Now, grown up,
approaching a milestone of middle age, it was safe to say on paper I had more than
most: a well-paid, challenging job in the media, to which I was virtually
married, a lovely house without an enormous mortgage, often exciting
relationships, great friends and I remained close to my stable family. And yet by
August 2000 my predominant talent was for crying.

I wish when I had first asked “What is the point?” I had been advised to
seek medical help urgently. I was talking to my friend Amy, who was no
stranger to depression herself, so I may have acted had she done so. Instead,
Amy told me a story of finding love herself, unexpectedly, and how it could
happen to me. She may even have taken the phrase “You often find someone
when you are not looking” for another turn. What I do vividly remember is
putting my feet up against the cool marble side of my fireplace, saying “I just
cannot see the point any more”, and crying.

A strong feeling of sadness about my childlessness had persuaded me to
seek the help of a psychotherapist, Judy, in the autumn of 1999 and I had been
visiting her regularly since. Judy, like the majority of therapists, took
the month of August as holiday, leaving me and a whole host of other therapy
regulars in a limbo land of summer anxiety. I looked to herbal drugs – St
John’s wort and others – to boost my spirits and, as ever, I threw myself
into the full responsibilities of my job.

What I was far from realising was that none of these tactics were enough.
Therapy alone cannot conquer a depressive illness, and neither can herbal
drugs. Making work the focus of your life is certainly not the answer. I
felt under-appreciated in my job, believed that my contribution counted for
nothing. I felt my body had let me down, and that I was useless physically as
well as professionally. The feeling was exacerbated when the last person
with whom I had had a physical relationship (and with whom I was still
involved) took up with someone more than 10 years younger. I found out,
painfully, through a third party. This was when my emotional strength started to
give out.

The crying got worse. At work, tears would inconveniently start to fall
down my face in the middle of writing an email or at the point of making a
phone call. In the past many had taken refuge in my office seeking privacy, a
shoulder, advice, a place to scream, and now the adjustable blinds became
an essential masking tool for my own distress. I frequently took time out to
weep in a neighbouring colleague’s office. She began to beg me to seek
help, but because I was in professional mode, I assured her I was really
working hard in therapy and a day didn’t go by without my taking the St John’s
wort. All would be fine.

Finally, I began to realise that taking pride in hiding the fact that I
was on the emotional skids was not a good end in itself. I rang my GP, Dr
Fahey, a plain-speaking, wise Irish woman. I was brave, then sniffled, then
howled, and she said there would be a prescription for me at the surgery that
night for Prozac. She assured me I could ring if I felt I needed to talk
before our appointment in a week’s time, and then she asked if I wanted time
off work. My response was an emphatic no. “I have to keep going into work.
Work is what I do.”

The next day was a Friday and I started taking the Prozac extremely
reluctantly. The side effects listed on the pack included headaches, dizziness,
diarrhoea, nausea, vomiting, abdominal pains, dry mouth, loss of appetite,
anxiety, sleeplessness, nervousness. If I am anxious now, I thought, how
anxious will I be on Prozac? If I wake at four each morning now, and toss and
turn for many of the hours that follow, will I get any sleep on Prozac?

The first night, I was lucky – friends invited me to stay, friends who
understood. But on Saturday, as I prepared to leave, I began to sink at the
thought of being alone. My friend was pregnant and to make more demands on
her and her partner felt wrong. We stood on her doorstep and she held me
close, hugging me and asking if I would be OK. “Yes,” I lied, then, more
truthfully: “I have to be.” But I cried all weekend.

By Monday I could not move. I felt sick, heavy as a rock, everything
ached, and my head swam. I had the pains and sort of breathlessness associated
with heart attacks and I was, of course, crying. I rang work to say I had
some sort of bug and that I hoped to be right the next day. Speaking was an
effort. It was hard convincing myself that the advantages to leaving the
house and seeing the doctor outweighed those of staying inside where I wanted,
desperately, to be, but I knew I needed to seek advice. Dr Fahey offered,
again, to sign me off work; my response, again, was an adamant no. I was
going into work as soon as I could.

Everyone has different experiences of how they interact with family while
in the grip of a depressive illness: some gain no support, some seek no
support, some have in mind that individual members of their family are largely
or totally responsible for their illness. Despite our lifestyles being
completely different, my sister, Amanda, was the one I could turn to at any
time.

I was struck by an inability to talk to my parents. I simply could not
pick up the phone, or see them. I keenly felt the weight of their love, and
therefore the weight of their disappointment that I was childless,
partnerless. I saw my own confusion and grief reflected back at me. Eventually I
began emailing them messages telling them a little – oh, such a little – of
what I was experiencing. I am sure it was partly a result of the good manners
they themselves had instilled in me that I made this faint but direct
contact. My preferred position was really to remain silent. What child wants to
tell the parents that gave them life that they want it ended?

By the time I returned to Dr Fahey three days later Amanda knew that
something was really wrong. I had told her that I found eating difficult and
that I was afraid to leave the house. I was ringing work each day to say I
still had not improved enough to go in. Mornings are the worst time for
depression and I was piling on the agony by setting myself the unrealistic target
of going to work and then feeling a failure when I was unable to meet it.
Dr Fahey advised that I cancel the regular appointment with Judy, my
therapist, for that week. At first I suspected professional competitiveness
(“I’ll save you” – “No, I’ll save you!”), but she was trying to prevent any
further introspection on my part. I could not see how I was going to get the
few miles across north London that the visit required anyway.

So for three days my sister and Judy coaxed me, by telephone, out of the
house. A 20-yard trip to the newsagent was fine, a trip to M&S was less
successful. I made it to the shop, but halfway round I froze. All that food,
all those people. I loaded up a basket then had to leave it mid-store and
struggle out of the shop to lean against the wall and gasp. I clutched at my
chest, I thought something might rupture.

All this time I kept thinking I would be back at work any minute. That I
had to be back at work. It was essential that people did not know there was
anything wrong. And, really, there was not anything wrong. I was barely
eating, I could barely leave the house, but I was surely fit for work. Surely.

After the second visit to Dr Fahey everything changed. She made me realise
that whatever self-deceptions I had entered into, the reality was that I
had not been into work for several days, nor was I currently fit to go in.
She signed me off for two weeks and gave me tranquillisers to moderate the
increasingly severe panic attacks. She advised me strongly to leave London.
The idea of being on my own without work for two weeks was unthinkable,
unbearable. Amanda was off to visit our parents in the country and taking the
children with her. My brother-in-law Neil was staying at home an extra
night then would join her there. Amanda’s suggestion was that I drive to be
with Neil and then the following day he would drive us both to Suffolk to be
with the whole family.

At their house that evening I crept into my nephew’s room, in his narrow
bunk bed and under his Star Wars duvet. I gasped and sweated through the
night. In the morning, Neil appeared with some tea and suggested we have
breakfast. Fine, I said, yes. Then I realised I might split in two if he left
the room. I gestured that I could do with a hug – and then I started the real
drop to the bottom. It was as if my chest was going to be rent in two.

As Neil pulled gently away I kept up appearances and said I would be down
for breakfast in a minute. I got as far as the bottom of the stairs and
realised I could not breathe, was going to faint, and sat there bleating for
Neil like some injured animal. You need to eat, he asserted. You need some
sugar, something. It had been so long since I had eaten properly my throat
was constricted; my head, heart, lungs felt squeezed. And the panic was
rising: what if I never eat again? What if I have to stay in this state? What
if? What if? I began to hyperventilate. Neil collected me up and calmly set
me on the sofa. He found some dextrose tablets and crammed them into my
mouth, he lifted my feet above my head and he repeated over and over again that
this was the worst, it would get better. But when I could speak I just
begged him tearfully to ring my doctor, to get me to hospital, to put me out
of my misery. To stop everything, to make it stop.

When Neil felt the panic attack had subsided enough he did go to the
phone. He did not ring my doctor, nor the hospital, but Amanda, who got in the
car and came back to be with me. In the following days I frequently asked if
I could be taken to hospital. I wanted, demanded, a lobotomy. I wanted
something to stop the pain, the panic, the screaming, the crying, the
darkness. I wanted some peace.

Amanda and Neil withstood my pleas and I am glad they did. I am not sure I
would have survived hospital. And I could not give up with my niece,
Jessica, and her brother, Alexander, around. “What is actually wrong with you?”
12-year-old Alexander asked repeatedly in the first few days, until my
sister took him to one side and gave him an explanation in her determined and
straightforward way. I was relieved. I did not know how to answer him, I did
not want to scare him and I did not want to lie. But apart from this one
small challenge the children were nothing but help to me. They would appear
in the morning and scramble on or into my bed and tell me what lay ahead
for them that day. And when there is someone so trusting asking you questions
as if your opinion still mattered and telling you stories as if it was
still important to impress you it is hard to plot and plan death, or much
harder anyway.

Amanda brought me breakfast in bed before she left for her teaching job.
Breakfast was a small glass of orange juice placed in the centre of a plate
with toast fingers arranged around the glass to look like a flower or a sun
– something hopeful. I did not feel worthy of such treatment and it would
make me cry. Neil worked from home so I was never alone, and Amanda would
ring me when she got to work, in her break and at lunchtime.

If my illness put a strain on Amanda and Neil’s marriage or their family
life as a whole they did not say. To help the days pass I did my best to
read carefully selected books – nothing with relationships in, nothing about
family love. I met Neil for lunch in the kitchen. I had become, as my mother
was to remark unforgettably, “a vegetable”. Most evenings were spent
inert, watching the family life go on around me. I listened to the children’s
music practice and I made occasional attempts to help with homework. I should
have known that a night of fractions with Jessica was unlikely to be good
for either of us. I had to leave her with her homework book pages rubbed raw
and almost transparent to howl in the bathroom. She clearly felt this was
a topsy-turvy world of role reversal. Wasn’t the child supposed to be in
tears of frustration not the adult?

While the family watched TV I tended to lie behind it as it continued to
induce a state of panic. I tried to hold on to vestiges of my own lifestyle.
Neil recorded The Sopranos for me, but I managed no more than a few
minutes. It did not induce panic, but anguish. Mine was no longer the life of a
sharp, media-savvy woman with sophisticated tastes – after all Amanda had to
gently chivvy me to wash my hair. I found that Alan Titchmarsh and other
toilers on the land and in the kitchen posed no threat. Being so far removed
from my former life made them oddly bearable to view.

Outside scared me. I felt flimsy and exposed. I did not want to be seen or
heard. When Amanda was home I followed her round like a shadow, always
keen to be in the same room, always keen to be held. I ate a little more food
and gained some substance, I had a few more hours’ sleep a night. Armed
with a mobile phone and a huge send off from Neil one day I left the house to
buy a paper. It is several hundred yards to the paper shop from their home,
but it felt like a major adventure, and as I paid for the paper I felt a
surge of spirit, a lightheartedness I had not experienced for some time.

And then my mobile rang. It was one of my friends, and I was able to share
my achievement with her: I had made it to the paper shop on my own. She
was so delighted she asked if I had planted a flag there. It was great. But
the next day I wept over our celebration. How pathetic. I was a 39-year-old
woman, a senior executive at a national newspaper, someone who at the
office made hundreds of decisions a day, a woman with a reputation for being
scary, and the biggest achievement of that week was leaving the house and
handing over loose change to buy the newspaper for which I was still officially
the spokesperson.

When the next visit to Dr Fahey loomed I decided I should venture back to
London a day or so earlier, the logic being that if I could not be on my
own in the house then I should not be going back to work. And going back to
work was my goal, and what I expected my doctor to be helping me to do. It
was a disaster. The appetite which had been coaxed into some sort of life in
the bosom of my sister’s family disappeared. There was no room in the
house that I could settle in. I could not sleep. I used the time to make my
will to plan which friends of mine struggling with infertility I would endow
with financial gifts when I was gone.

Dr Fahey was prepared to give me a very, very limited supply of sleeping
tablets but “not enough to kill yourself with”. I think I smiled at that.
“Do you ever think of killing yourself?” she asked quickly. “I rarely think
of anything else,” was my response. “And how would you feel about seeing a
psychiatrist?” Fine, I said, fine. They would make a home visit. Fine. On
returning home I panicked. Was I going to be sectioned?

I immediately rang my friend Roger who had had a hand in sectioning
someone in the past. His advice was that it takes two to section. If I saw two
through the fish-eye in the door then I should not let them in.

A short time later my doctor rang and told me that there would probably be
two people who would visit me, a psychiatrist and a psychoanalyst. Two? I
started to shake. “Will they take me anywhere?” I asked coyly. “I do not
know,” my doctor replied. “Only if they think it is necessary.” As soon as I
put down the receiver there was an incoming call from Siobhain, a lawyer as
well as a friend, who, alerted by Roger, was offering to come and be in
loco parentis to prevent a sectioning. And then Martin, the psychiatrist,
rang. “I will be with you in half an hour.”

Perhaps I could convince them that I was not mad. The lethargy which
almost permanently overwhelmed me was temporarily thrown off as I set about
making my house look sane. I made piles of paper, I cleaned the tea mugs, I
folded the rug under which I spent most time. Then I had an inspiration.
Recycling. If I put some paper in the recycling bin it would look as if I was
investing in the future.

When Martin arrived on the doorstep he appeared to be on his own. I made
tea for us in a scene straight from a badly acted kitchen drama; the spoons
and china clattered as I tried, unsuccessfully, to keep the shaking under
control. We sat in my living room. I questioned him. “Are you really on your
own?” and “Are you going to take me anywhere?” He stated reassuringly that
there was no one waiting outside.

Things got better after that. He gave a name to what I was suffering – a
serious depressive illness – which at its worst was a killer. He identified
a singular problem and spoke it out loud. “So you feel you are incapable of
doing anything, of being good at your job, of holding down a relationship,
of being a mother, and now you cannot even kill yourself, is that right?”
So right, so right, I could not speak. This was a jam I could not see my
way out of – and I was not at all sure that Martin, or any other well meaning
person, could help me out of it either.

It was months into my illness before any of the professionals ventured to
use the term breakdown. It was several more before I learnt that this was
not a cause to feel ashamed.

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Ban Avandia & Save Per Month 300 from Heart Failure & 500 from Heart Attacks!

The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.
“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the F.D.A. to issue a warning, and sales plunged.

http://blogs.healthfreedomalliance.org/blog/2010/02/22/once-again-big-pharma-lies-and-people-die/

Feb

22

Once Again Big Pharma Lies And People Die

Filed Under Big Medicine, Big Pharma, FDA, Medical Maiming

Bush lied people died, whoops wrong website. Big Pharma lied people died. There that’s better. In what should be a shocking report but now is all to common, Glasko Smith Kline got caught lying about the dangers of their blockbuster diabetes drug named Avandia. Health Freedom Alliance assumes the penalty will be a small fine and increased campaign contributions. Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.

The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.

“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” the risk of heart attacks.

The battle has been brewing for years but has been brought to a head by disagreement over a new clinical trial and a Senate investigation that concluded that GlaxoSmithKline should have warned patients earlier of the drug’s potential risks.

Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the F.D.A. to issue a warning, and sales plunged. A committee of independent experts found in 2007 that Avandia might increase the risk of heart attack but recommended that it remain on the market, and an F.D.A. oversight board voted 8 to 7 to accept that advice.

Hundreds of thousands still take the medicine, although some top endocrinologists say they have sworn off the drug.

Since 2007, more studies have been done. In a December 2009 internal memorandum, Dr. Janet Woodcock, director of the F.D.A.’s drug center, wrote that “there are multiple conflicting opinions” about Avandia within the agency, and she ordered officials to assemble another advisory committee, expected this summer, to reconsider whether the drug should be sold.

“I await the recommendations of the advisory committee,” the agency’s commissioner, Dr. Margaret Hamburg, said Friday night. “Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved.”

The bipartisan multiyear Senate investigation — whose results are expected to be released publicly on Monday but which were also obtained by The Times — sharply criticizes GlaxoSmithKline, saying it failed to warn patients years earlier that Avandia was potentially deadly.

“Instead, G.S.K. 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,” concludes the report, which was overseen by Senator Max Baucus, a Montana Democrat, and Senator Charles E. Grassley, an Iowa Republican.

Mr. Baucus said of the report, “Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.”

In response, GlaxoSmithKline said that it disagreed with the Senate investigation’s conclusions. The company said that it could not comment on internal F.D.A. documents but that “the official ruling from F.D.A. is that Avandia remain on the market.”

In the wake of the controversy, agency officials ordered GlaxoSmithKline to undertake a study comparing how many heart attacks, strokes and heart-related deaths occur among patients given either Avandia, Actos or a placebo. Studies suggest that Actos, made by Takeda, lowers blood sugar as well as Avandia but without hurting the heart as much.

But Dr. Graham and Dr. Gelperin, working in the F.D.A.’s office of surveillance and epidemiology, argued in two separate internal reports that the new GlaxoSmithKline study, called TIDE, is “unethical and exploitative” because patients given Avandia face far greater risks than those given Actos, with no promise of any additional benefit. The trial may include patients who have had heart attacks or chest pains even though some foreign drug authorities have warned against Avandia’s use by precisely such patients, the reports note.

“Although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable,” one of the reports concludes.

These concerns, in internal reports dated October 2008 but not made public until now, were later overruled by other agency officials, and GlaxoSmithKline is currently enrolling patients in the TIDE trial. The trial is not expected to be completed until 2020, although the company is hoping to report some results to the F.D.A. by 2014. The company’s patent on Avandia expires in 2012, and generic versions will probably swallow most remaining profits.

http://www.nytimes.com/2010/02/20/health/policy/20avandia.html?hp

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Antidepressants and anti-anxiety medications & heart risks

NOTE FROM Ann Blake-Tracy:

Although there have been concerns voiced and many other
studies released on this issue here is a study that was just released yesterday
morning – the morning after Britney Murphey’s sudden death.
____________________________________
Antidepressants and anti-anxiety medications may increase the
risk of heart disease, heart attacks and stroke in women, a new study
indicates.

Antidepressants up heart disease risks

[Posted: Mon 21/12/2009 by Olivia Fens]

Antidepressants and anti-anxiety medications may increase the
risk of heart disease, heart attacks and stroke in women, a new study
indicates.

According to researchers, from Uniformed Services University
in the US, women with suspected coronary artery disease (CAD) who were taking
antidepressant and anti-anxiety medications had an increased risk of
cardiovascular events, compared to women not taking these
medications.

“It needs to be considered that taking antidepressant and
anti-anxiety medications may not be beneficial, and may in fact be harmful for
some women,” the researchers said.

The authors of the study, however,
said further research was needed to examine whether factors such as underlying
depression and anxiety, and not medications per se, may be responsible for these
results.

Nevertheless, they added that the findings of the study
emphasised the importance of emotional and psychosocial factors in women with
suspected coronary artery disease.

The paper was published in the journal
Heart.

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