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 Both authors recommended that Avandia be withdrawn.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 Both authors recommended that Avandia be withdrawn.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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4/15/2001 – Prozac critic sees U of T job revoked

This article makes it very clear what unethical tactics Lilly and other
pharmaceutical companies use regularly. With Lilly being the major
contributor to this university it should be obvious who pulls the strings in
this situation.

Who is pulling the strings at your alma mater? Drug companies have tied up
about every university in this country and around the world to gain control
over the disinformation coming out of those universities in the form of
“medical studies.” Yes, those same studies we just learned are being
“ghostwritten” by pharmaceutical companies and then pawned off to the public
as the “gospel truth” or “credible scientific evidence.”

You see they need that control over the studies so that they can make
statements like this: “There is no credible scientific evidence that
establishes a causal link between Prozac [fluoxetine hydrochloride] and
violent or suicidal behavior.”

Dr. David Healy is perhaps their greatest threat when it comes to the SSRIs.
I am sure that part of their motive was a hope that this move might become a
“black mark” on his resume that they could use against him in court to
discredit him. I know all too well that they will twist everything they can
to discredit those who have the courage to stand up for the truth against
them. And, Dr. Healy does that well.

I don’t know why they would not want anyone to hear what Dr. Healy is saying
about Prozac, such as: “the data show that Prozac and other popular
antidepressants in the same chemical family may have been responsible for one
suicide for every day they have been on the market.”

If I were the CEO of Lilly I would be thinking, “Wow! That would be a VERY
LARGE number of lawsuits to have to settle.” Now I can’t imagine what has
made them so upset as to ruin Dr. Healy’s new position, can you?

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

http://www.globeandmail.com/

Saturday, April 14

Prozac critic sees U of T job revoked

By ANNE McILROY
From Saturday’s Globe and Mail

A world-renowned scientist saw a job offer at the University of Toronto
evaporate after warning that the popular antidepressant Prozac may trigger
suicide in some patients.

The drug’s manufacturer, Eli Lilly, is an important private donor to a
mental-health research institute affiliated with the university.

Critics say it appears that David Healy’s job offer was rescinded to avoid
offending the corporate giant or for fear of compromising future fundraising
efforts.

Eli Lilly said it had no role in the matter. The university said the decision
not to hire Dr. Healy was made by the Centre for Addiction and Mental Health,
an affiliated teaching hospital, and that it would not be proper for the
university to question it. The Centre for Addiction and Mental Health, for
its part, steadfastly denies that it has allowed fundraising concerns to
interfere with academic freedom.

“If you are asking me if his comments influenced our decision, let me be
clear that there were a number of factors involved. We regret that our
actions have been misinterpreted as an attack against academic freedom and as
a conflict of interest,” said Paul Garfinkel, chief executive officer of the
CAMH.

Dr. Garfinkel said the reasons for the decision to revoke Dr. Healy’s job
offer are confidential. “Let me be clear, we’ve never made an offer or
withdrawn an offer on the basis of an impact on an outside donor.”

When initially approached by The Globe and Mail several months ago, Dr.
Healy, who works at the University of Wales, was reluctant to speak publicly
about what happened.

He said he decided to do so to publicize his concerns about Prozac and to
raise questions about the appearance of a conflict of interest at U of T.

“I’ve had people call from a number of countries asking whether it is safe to
say something [critical] about pharmaceutical companies. The public needs to
know what happened here,” he said in an interview.

Dr. Healy said that he made his views clear in private interviews with
university officials before the speech.

University of Toronto colleagues are providing a public platform for him to
express his views on Prozac next week. He will give a lecture at the Joint
Centre for Bioethics on Thursday evening.

U of T and CAMH had been courting Dr. Healy since July of 1999. They made him
a formal written offer of a combined faculty and clinical position in May of
2000, followed by a more detailed letter in August.
They hired a lawyer to help him immigrate.

Then, on Nov. 30, 2000, Dr. Healy gave a wide-ranging lecture at CAMH, part
of a colloquium titled Looking Back, Looking Ahead — Psychiatry in the 21st
Century: Mental Health and Addiction.

He criticized pharmaceutical companies for avoiding experiments that could
demonstrate problems with their drugs, and for not publishing unfavourable
results. He said the data show that Prozac and other popular antidepressants
in the same chemical family may have been responsible for one suicide for
every day they have been on the market.

A week later, Dr. David Goldbloom, physician-in-chief at CAMH and a professor
at U of T, rescinded the offer to Dr. Healy in an e-mail, a copy of which was
sent to The Globe and Mail in an unmarked brown envelope.

Dr. Goldbloom told Dr. Healy his lecture was evidence that his approach was
not “compatible” with development goals. Development, in the university
context, is widely understood to mean fundraising, although CAMH denies that
fundraising was what was meant.

Eli Lilly, the drug company that manufactures Prozac, is its “lead” donor
according to the CAMH Web site, contributing more than $1-million to the
centre’s $10-million capital-fundraising campaign.

Last year, Eli Lilly cancelled its $25,000 (U.S.) annual donation to the
Hastings Center in New York, a think tank that looks at ethical issues, after
it published a series of articles about Prozac, including a critical one by
Dr. Healy titled Good Science or Good Business.

“The centre had published articles that Lilly felt contained information that
was biased and scientifically unfounded and that may have led to significant
misinformation to readers, patients and the community,” said Laurel Swartz,
manager of corporate communications for Eli Lilly.

Two U of T professors, who have asked that their names not be published, said
that what happened to Dr. Healy in Canada raises disturbing questions about
whether professors are free to be critical of drug companies in an era where
medical schools are heavily dependent on them for financing.

James Turk, executive director of the Canadian Association of University
Teachers, said the paper trail appears to make it clear why Dr. Healy was no
longer welcome at U of T.

“The language they use indicates they feel they can’t hire this guy because
it will give them trouble raising money,” Mr. Turk said.

Experts such as Bob Michels, the former head of medicine at Cornell
University in New York, say Dr. Healy is internationally renowned, both as a
clinical psychopharmacologist and a historian of the role of drugs in modern
psychiatry.

He is also well-known for his outspoken criticism of Prozac and other similar
drugs and has appeared as an expert witness on behalf of families suing Eli
Lilly and other drug companies.

Dr. Healy says the data show Prozac and related medications, which are widely
prescribed for people who in the past would not be deemed sick enough to
require medication, can cause patients with no history of mental illness to
fall into a state of extreme agitation anxiety. In some cases it can lead to
suicide, or thoughts of suicide.

Last year, Dr. Healy published a study that found that two healthy volunteers
out of 20 who were given Prozac reported feeling extremely anxious and that
they entertained thoughts of suicide.

Eli Lilly says Prozac is safe. “There is no credible scientific evidence that
establishes a causal link between Prozac [fluoxetine hydrochloride] and
violent or suicidal behaviour,” Ms. Swartz said.

Dr. Healy insists warning labels are needed on Prozac so doctors will know to
watch for suicidal tendencies when they prescribe the antidepressant.

His speech did not go over well at U of T. Dr. Healy said Dr. Goldbloom
appeared unhappy when they discussed the lecture at a dinner that evening.

Dr. Healy said he understood Dr. Goldbloom to be critical of his speech
because people would take away from it the understanding that Prozac makes
people suicidal and the Eli Lilly knew about the problem but wouldn’t
acknowledge it.

Dr. Healy left that weekend for New York, where he was scheduled to give the
same speech at Cornell University.

On the Monday after the Thursday speech, Dr. Goldbloom began sending Dr.
Healy e-mails saying it was urgent they find a time to talk by telephone. Dr.
Healy kept copies of them, and has provided them to The Globe and Mail.

When the two men couldn’t arrange the phone call, Dr. Goldbloom sent the
e-mail rescinding the job offer on behalf of both CAMH and U of T.

“Essentially, we believe that it is not a good fit between you and the role
of leader of an academic program in mood and anxiety disorders at the Centre
and in relation to the University. This view was solidified by your recent
appearance at the Centre in the context of an academic lecture,” the message
said.

“While you are held in high regard as a scholar of the history of modern
psychiatry, we do not feel your approach is compatible with the goals for
development of the academic and clinical resource that we have.”

Dr. Goldbloom would not be interviewed for this story. Dr. Garfinkel said he
didn’t know what Dr. Goldbloom had said to Dr. Healy in person after the
speech. But he categorically denied that when Dr. Goldbloom referred to the
development of the centre he was referring in any way to the ability to raise
funds, either from Eli Lilly or other drug companies.

“Development is a technical term that many places use to talk about
fundraising. This is development of a program, totally different meaning,”
Dr. Garfinkel said.

He said the meeting where senior managers from U of T and CAMH made the
decision to rescind the job offer was on Dec. 8. Yet Dr. Goldbloom sent the
e-mail on Dec. 7, and began requesting an interview by phone several days
before that.

Dr. Healy didn’t quit his job in Wales and said he is not planning legal
action. He said he has asked for a more detailed explanation about why the
job offer was rescinded, but none was given. He said he would like to hear
from Dr. Garfinkel about the confidential reasons the job offer was revoked.

“Nobody has offered me any other reasons at all. I don’t believe there are
any other reasons. We have the paper trail, and what I am asking them to
explain is the paper trail. Maybe there is an explanation that will let them
off the hook, but if there is, maybe they could try explaining it to me.”

He certainly never imagined that his speech, which contained nothing he
hasn’t said before, would cost him the job.

In fact, Dr. Michels said the same speech did not cause problems at Cornell.

“He certainly has many people who sharply differ with him. That’s not unusual
in science. He has points of view that other people don’t agree with. He has
certainly been very open and expressive about his points of view. The
material is an area where there is great controversy, and he takes positions
in that controversy, but they are well within the dialogue in his field.”

This is the second controversy of its kind at the university. Researcher
Nancy Olivieri faced an ugly internal battle and a lawsuit in when she
published data unfavourable to the drug company that funded her work.

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10/19/1999 – PFIZER REJECTS NEUTRAL, COURT-APPOINTED EXPERT

Here is news release in a pivotal wrongful death case involving Zoloft.
For more information on this case, you may want to visit
(drugawareness.org/memorial/matt-miller)

FOR IMMEDIATE RELEASE (OCTOBER 19, 1999):

PLAINTIFFS WILLING TO HAVE SCIENTIFIC EVIDENCE IN WRONGFUL
DEATH/SUICIDE CASE AGAINST MANUFACTURER OF ZOLOFT MEASURED BY NEUTRAL,
COURT-APPOINTED EXPERTS. PFIZER IS NOT.

MARK AND CHERYL MILLER OF KANSAS CITY HAVE FILED SUIT AGAINST PFIZER,
ALLEGING THAT ITS $2 BILLION DOLLAR PER YEAR PSYCHOACTIVE DRUG “ZOLOFT”
CAUSED THEIR 13 YEAR OLD SON TO COMMIT SUICIDE 7 DAYS AFTER HE WAS
GIVEN SAMPLES OF THE DRUG. PFIZER VEHEMENTLY DENIES THAT ITS DRUG
CAUSES ANY PATIENT TO COMMIT ACTS OF VIOLENCE OR SUICIDE.

TAKING THEIR CUE FROM A RECENT SUPREME COURT OPINION, THE MILLERS HAVE
SUGGESTED THAT THE JUDGE COULD AND SHOULD APPOINT A “NEUTRAL”,
OBJECTIVE EXPERT TO ADVISE HER AS TO WHETHER THE EXPERTS ON BOTH SIDES
ARE USING “SCIENTIFICALLY RELIABLE” METHODOLOGIES AND REASONING.

THE MILLERS’ COUNSEL, ANDY VICKERY OF HOUSTON, TEXAS
(andy@…) SAID THAT HE WAS DISAPPOINTED WITH PFIZER’S
UNWILLINGNESS TO HAVE A NEUTRAL SCIENTIST ADVISE THE COURT. “THE DRUG
COMPANIES YAP AND YAP ABOUT JUNK SCIENCE ALL OF THE TIME,” VICKERY
SAID, “BUT IT SEEMS TO ME THAT `JUNK SCIENCE’ TO THEM MERELY MEANS
SCIENCE FROM SOMEONE THAT THEY AREN’T PAYING AND CAN’T CONTROL”. THE
MILLERS’ PRINCIPAL LIABILITY EXPERT, DR. DAVID HEALY, WROTE THE HIGHLY
ACCLAIMED HARVARD PRESS BOOK, “THE ANTIDEPRESSANT ERA”, AND HAS ALREADY
BEEN RECEIVED BY ONE FEDERAL COURT AS A QUALIFIED EXPERT IN THIS AREA.

FEDERAL JUDGE KATHRYN VRATIL OF KANSAS CITY WILL DECIDE THE MOTION.

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