ANTIDEPRESSANT, PAIN KILLER & ALCOHOL: Soldier: Suicide Attempt: Iraq/Colorado

Paragraphs three through five read: “It did not work. He was prescribed a
list of medications for anxiety, nightmares, depression, and headaches
that made him feel listless and disoriented.”

“His weekly session with a nurse case manager seemed inadequate to him.
And noncommissioned officers ­ soldiers supervising the unit ­
harangued or disciplined him when he arrived late to formation or violated rules.”

“Last August, Crawford attempted suicide with a bottle of whiskey and
painkillers. By the end of last year, he was begging to get out of the unit.”

http://www.boston.com/news/nation/articles/2010/04/25/some_soldiers_find_no_
relief_in_transition_units/

Some soldiers find no relief in transition units

Army defends efforts to help returning troops

By James Dao and Dan Frosch

New York Times / April 25, 2010

COLORADO SPRINGS ­ A year ago, Specialist Michael Crawford wanted
nothing more than to get into Fort Carson’s Warrior Transition Battalion, a
special unit created to provide closely managed care for soldiers with
physical wounds and severe psychological trauma.

A strapping Army sniper who once brimmed with confidence, he had returned
emotionally broken from Iraq, where he suffered two concussions from
roadside bombs and watched several platoon mates burn to death. The transition
unit at Fort Carson seemed the surest way to keep suicidal thoughts at bay,
his mother thought.

It did not work. He was prescribed a list of medications for anxiety,
nightmares, depression, and headaches that made him feel listless and
disoriented.

His weekly session with a nurse case manager seemed inadequate to him. And
noncommissioned officers ­ soldiers supervising the unit ­
harangued or disciplined him when he arrived late to formation or violated rules.

Last August, Crawford attempted suicide with a bottle of whiskey and
painkillers. By the end of last year, he was begging to get out of the unit.

“It is just a dark place,’’ said the soldier, who is waiting to be
medically discharged from the Army. “Being in the WTU is worse than being in Iraq.
’’

Created in the aftermath of the scandal in 2007 over shortcomings at
Walter Reed Army Medical Center, Warrior Transition Units were intended to be
sheltering way stations where injured soldiers could recuperate and return to
duty or gently process out of the Army. There are about 7,200 soldiers at
32 transition units across the Army, with about 465 soldiers at Fort Carson’
s unit.

But interviews with more than a dozen soldiers and health care
professionals from Fort Carson’s unit, along with reports from other posts, suggest
that the units are far from being restful sanctuaries.

For many soldiers, they have become warehouses of despair, where damaged
men and women are kept out of sight, fed a diet of powerful prescription
pills, and treated harshly by noncommissioned officers. Because of their
wounds, soldiers in Warrior Transition Units are particularly vulnerable to
depression and addiction, but many soldiers from Fort Carson’s unit say their
treatment there has made their suffering worse.

Some soldiers in the unit, and their families, described long hours alone
in their rooms, or in homes off the base, aimlessly drinking or playing
video games.

“In combat, you rely on people and you come out of it feeling good about
everything,’’ said a specialist in the unit. “Here, you’re just floating.
You’re not doing much. You feel worthless.’’

At Fort Carson, many soldiers complained that doctors prescribed drugs too
readily. As a result, some soldiers have become addicted to their
medications or have turned to heroin. Medications are so abundant that some
soldiers in the unit openly deal, buy, or swap prescription pills.

Heavy use of psychotropic drugs and narcotics makes it difficult to
exercise, wake for morning formation, and attend classes, soldiers and health
care professionals said. Yet noncommissioned officers discipline soldiers who
fail to complete those tasks, sometimes over the objections of nurses and
doctors.

At least four soldiers in the Fort Carson unit have committed suicide
since 2007, the most of any transition unit as of February, according to the
Army.

Senior officers in the Army’s Warrior Transition Command declined to
discuss specific soldiers. But they said Army surveys showed that most soldiers
treated in transition units since 2007, more than 50,000 people, had liked
the care.

Those senior officers acknowledged that addiction to medications was a
problem, but denied that Army doctors relied too heavily on drugs. And they
strongly defended disciplining wounded soldiers when they violated rules.
Punishment is meted out judiciously, they said, mainly to ensure that soldiers
stick to treatment plans and stay safe.

“These guys are still soldiers, and we want to treat them like soldiers,’’
said Lieutenant Colonel Andrew Grantham, commander of the Warrior
Transition Battalion at Fort Carson.

The colonel offered another explanation for complaints. Many soldiers, he
said, struggle because they would rather be with regular, deployable units.
In some cases, he said, they feel ashamed of needing treatment.

“Some come to us with an identity crisis,’’ he said. “They don’t want to
be seen as part of the WTU. But we want them to identify with a purpose
and give them a mission.’’

Sergeant John Conant, a 15-year Army veteran, returned from his second
tour of Iraq in 2007 a changed man, according to his wife. Angry and sullen,
he reported to the transition unit at Fort Carson, where he was prescribed
at least six medications a day for sleeping disorders, pain, and anxiety,
keeping a detailed checklist in his pocket to remind him of his dosages.

The medications disoriented him, Delphina Conant said, and he would often
wander the house late at night before curling up on the floor and falling
asleep. Then in April 2008, after taking morphine and Ambien, the sleeping
pill, he died in his sleep. A coroner ruled that his death was from natural
causes. He was 36.

Delphina Conant said she felt her husband never received meaningful
therapy at the transition unit, where he had become increasingly frustrated and
was knocked down a rank because of discipline problems. “They didn’t want
to do anything but give him medication,’’ she said.

© Copyright 2010 Globe Newspaper Company.
.

 2,798 total views

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

 1,394 total views

7/25/2000 – Ewing’s Letter to the New York Times

Mr. Rick Ewing, a trial attorney for the firm of Vickery and Waldner,
responds to the purported balance of opinions expressed in the
New York Times article on Prozac and violence (Article #108 on
our eGroups list).

It is a wonderful analysis, and I hope you’ll read it. Mark
——-

Ms. Goode’s article is a balanced account of an ongoing debate
about suicide and violence temporally associated with the SSRI
drugs. If “opinion leaders” differ sharply then we are in
intellectual equilibrium.

Right? Wrong. The leaders are as data-starved as the public.
The FDA is charged with accumulating and interpreting
post-marketing data on drug adverse events, and there is data
on well over a million events in the records of that agency. There
is no funding for meaningful analysis, and no initiatives for
funding. The data simply sit there. Neither is there any
requirement that drug companies investigate and report in detail
to the agency on adverse events. They are simply reported. If
the death and injury toll from a particular formulation, such as
“Oraflex” or “Fen-Phen” is overwhelming, the drug may be
withdrawn, not because of a systematic analysis, but because
the death toll speaks for itself.

What about less blatant data? By the fall of 1997, the FDA had
collected more than 44,000 adverse event in connection with
Prozac, more than the sum total of all reports on all psychoactive
drugs in history. The FDA receives reports on less than 10% of
the actual events by its own estimates. www.fda.gov. Those
reports now include more than 2500 deaths reasonably related
to suicide and violence. In fact, the pre 1998 reports are
scattered among some fifteen different “CO-START” terms
depending on the subjectivity’s or thoroughness of the reporting
physician. (There were 15 single-spaced pages of such terms,
a monument to ambiguity when applied to psychoactive drugs.)
Interestingly there was no term for either “suicide” or “murder.”
The majority of deaths (OUTCOME: DIE) are coded to the terms
“suicide attempt”, somewhat euphemistic applied to completed
suicides. By October of 1997, there were more than 1500 Prozac
deaths clearly coded to suicide or murder and another 300 for
which suicide or murder was the most plausible conclusion.

The United States Army developed an accepted technique for
investigating an alarming suicide rate among recruits – the
psychological autopsy, based on in-depth study of the subject’s
psychological history, and immediate life circumstances. It is
accepted as a generally useful technique. What kinds of
questions could have been answered if drug companies were
required to utilize psychological autopsies through independent
investigators?

Were there suicidal thoughts before the administration of the
drug? Did the suicide appear impulsive? Was the suicide
inconsistent with life-affirming elements? Did survivors consider
the suicide shocking and inconsistent? Did the deceased use
violent or grotesque modalities for suicide?
……………………..

Would it be useful and germane to the ongoing debate which
Ms. Goode so ably describes to have answers to those
questions for some 2500 deaths under SSRI drugs?

Would it be of interest that while men in the general population
are more than 8 times as lethal in their suicidal gestures as
women, that under these drugs men and women commit
suicide at almost equal rates? The suicide rates in the United
States hover around 30,000 per year, varying a few hundred.
Men commit suicide at a rate 4.3 to 1 over women. But
depression is thought to be twice as prevalent in women. It
would follow that men are more than 8 times as lethal in
depression suicides as women. Yet the demographic figures
connected with the adverse reports on Prozac (and other SSRI
drugs) show that women commit suicide at almost equal rates
with men, over 40%. Are these drugs obliterating what is
otherwise an immutable behavioral difference between men and
women?

If anyone has struggled through this letter, I have to admit that I
am a plaintiff’s lawyer who has been involved in SSRI litigation
for the past 10 years. You can now turn me into a cartoon
symbol of unalloyed greed, but before you do, isn’t it a frightening
thought that the only people on the trail of SSRI tragedy are
people like me? Shouldn’t there be others?

Congratulations on a very professional article. How I would love
to see you take on an in-depth study of the sources of
information and misinformation relating to licensed drugs!

Sincerely,
Richard W. Ewing
rick@…

 2,065 total views

09/24/1999 – John Horgan New York Times Interview

Here’s an insightful interview from the New York Time with Mr. John
Horgan, entitled “A Heretic Takes On the Science of the Mind.”

In 1996, Mr. Horgan, then a senior writer with The Scientific American,
published “The End of Science: Facing the Limits of Knowledge in the
Twilight of the Scientific Age,” a 281-page essay in which he argued
that scientific inquiry has gone about as far as it can go and that the
questions remaining for it to answer are unanswerable. Many scientists
were outraged, but the book sold nearly 200,000 copies.

This month, Mr. Horgan will no doubt be making a new set of enemies
with the release of his latest work — “The Undiscovered Mind — How
the Human Mind Defies Replication, Medication and Explanation” (Free
Press, $25). “I think of myself as a heretic,” he says, “who is
challenging the central dogma that scientific progress is eternal.”

Copyright 1999 The New York Times Company

http://www10.nytimes.com/library/national/science/092199sci-conversatio
n-horgan.html

 1,893 total views