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 Both authors recommended that Avandia be withdrawn.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 Both authors recommended that Avandia be withdrawn.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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DR. IRVING KIRSCH: EXPLODING THE ANTIDEPRESSANT MYTH

http://reporter.mcgill.ca/2009/10/antidepressants-medical-boon-or-bust/

Home > Reporter

The
Reporter

McGill University | Montreal, Quebec |
Oct 09 2009

Antidepressants: medical boon or
bust?

The Biomedical Ethics Unit of the Faculty of Medicine is
proud to present Dr. Irving Kirsch who will deliver a lecture titled “The

Emperor’s New Drugs: Exploding the Antidepressant Myth,” on Oct. 14.

When asked about the subject matter of his lecture, Dr. Kirsch, a Psychology
professor at the University of Hull, in England, said this. “Antidepressants
work – everyone knows they do. That’s what I thought too, until my colleagues
and I analyzed the clinical trial data. When I obtained the unpublished as well
as published data from the Food and Drug Administration, I found that what
everyone knew about antidepressants was wrong. Instead of treating depression
with drugs, we’ve been treating it with suggestion. A thorough review of the

research demonstrates that the chemical imbalance theory of depression is wrong.
The effect of antidepressant drugs is independent of their chemical composition.
Depression can be treated more effectively and more safely without drugs.”

The Emperor’s New Drugs; Oct. 14; 12:30 – 1:30 p.m. 3647 Peel St., room
101. Lecture is free, all are welcome. For more information contact Audrey M.
Prosser at 514-398-6980 or by email at

audrey.prosser@mcgill.ca.

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PAXIL: BIRTH DEFECTS – TEST CASE FOR OVER 600 MORE CASES – USA

First two paragraphs read:  “GlaxoSmithKline P.L.C., the
world’s second-biggest drugmaker, begins a trial in Philadelphia next week in
what may be a test case for more than 600

lawsuits over claims that the company’s antidepressant drug Paxil causes birth defects.”

“Patients and their parents say internal company documents
show Glaxo failed to warn consumers about the risks of Paxil until forced
to do so in 2005 by the Food and Drug Administration.
In the trial set
to start Monday, Michelle David blames the drug for causing life-threatening
heart defects in her son, Lyam Kilker, now age 3.”

Glaxo trial opens here Monday in what could be Paxil test case

By Sophia Pearson and Margaret Cronin Fisk

Bloomberg
News
GlaxoSmithKline P.L.C., the world’s second-biggest drugmaker, begins a
trial in Philadelphia next week in what may be a test case for more than 600

lawsuits over claims that the company’s antidepressant drug Paxil causes birth
defects.

Patients and their parents say internal company documents show
Glaxo failed to warn consumers about the risks of Paxil until forced to do so in
2005 by the Food and Drug Administration. In the trial set to start Monday,
Michelle David blames the drug for causing life-threatening heart defects in her
son, Lyam Kilker, now age 3.

The company, based in London and with major
operations in Philadelphia and its suburbs, faces two more such trials each
month from October through January in state court in Philadelphia.

“The
early cases set the parameters for any global settlement negotiations,” said
David Logan, dean and professor of law at Roger Williams University in Bristol,
R.I.

Paxil, approved by the FDA in 1992, generated about $942 million in
sales last year, 2.1 percent of the total for the company.

Glaxo has
settled other Paxil-related cases, including a suit brought by the New York
Attorney General’s Office accusing the company of withholding safety data about
the antidepressant.

The drugmaker isn’t liable for Lyam Kilker’s heart

defects, and it acted responsibly in testing Paxil and updating safety
information, Kevin Colgan, a Glaxo spokesman, said in an e-mail.

“The
scientific evidence simply does not establish that exposure to Paxil during
pregnancy caused Lyam Kilker’s condition,” Colgan said. “Very unfortunately,
birth defects occur in 3 to 5 percent of all live births, whether or not the
mother was taking medication during pregnancy.”

The FDA said in an alert
to doctors on Dec. 8, 2005, that preliminary studies suggested Paxil might
contribute to heart defects in infants when taken in the first three months of
pregnancy. The government asked the company to update the label enclosed with
the medicine, changing its birth-defect warning.

The FDA’s action does
not prove any connection between Paxil use and birth defects, Glaxo said in
court filings in July.

“GlaxoSmithKline will show it acted properly and
responsibly in conducting its clinical trial program for Paxil, in marketing the
medicine, in monitoring its safety once it was approved for use and in updating
pregnancy information in the medicine’s label as new information became
available,” Glaxo’s Colgan said.

Lawyers for patients say Glaxo
documents show the company had known since 1980 that Paxil could raise the risk
of birth defects.

Buzz
up!
Buzz this story.

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4/9/2001 – FDA Doc Claims Fen-Phen Cover Up

Once again the CBS Health Watch has given us another great article – this
time on the subject of corruption in the FDA.

With this revelation about the cover up with Fen-Phen let us hope that the
truth will begin to come out about the rest of these dangerous serotonergic
drugs. The real shame about Fen-Phen and Redux is that the drug company is
still getting away with all the psychiatric side effects their drugs
produced. The serotonergic effect with these drugs produced as many psychotic
breaks as the SSRIs have and in the end we will see that the SSRIs are
producing similar heart and lung problems as Fen-Phen and Redux did.

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

http://cbshealthwatch.medscape.com/SRS/c/ShowDoc.asp?ContentID=214123&ContentType=5

FDA Doc Claims Fen-Phen Cover Up

April 7 (CBS) The drug company that manufactured “fen-phen,” a diet
medication linked to heart ailments, covered up problems with the drug that
emerged during Food and Drug Administration testing, a former FDA scientist
tells CBS News.

Fen-phen was removed from the market in 1997. Thousands of people who took
the drug have sued American Home Products of Madison, N.J., for health
problems they claim the drug caused.

In an Eye on America investigation, CBS News Correspondent Sharyl Attkisson
reports the FDA’s key reviewer of fen-phen, Dr. Leo Lutwak, claims the
company knew about the problems long before the drug was pulled.

“I felt from the very beginning the drug companies were covering up. I felt
from the very beginning that these drugs were dangerous,” said Lutwak.

He claims American Home Products twisted the meaning of his research to make
it seem as if there was no way to predict fen-phen’s hazards.

“What I had actually written was, that in view of the covering up of
information by the drug company, the FDA had no way of predicting some of
these side effects,” he said.

One of those who sued American Home Products was Patricia Buol, who developed
severe heart problems after taking fen-phen. She’s now in line for a life
saving heart-lung transplant.

The company settled with Buol this week.

“Being part of my kids’ lives and doing their everyday activities is a
struggle,” said Buol. “But I just take one day at a time and do the best I
can.”

Dr. Lutwak’s testimony is crucial to fen-phen cases like Buol’s. But the FDA
won’t let him testify. Now Lutwak says he’s planning to retire, making him
free to testify at will.

“I followed the rules and regulations, I didn’t go public. I tried to work
within the system, it didn’t work. People died as a result of a dangerous
deadly drug being released,”he said.

Defendant American Home Products would not be interviewed, but has said in
the past it “acted responsibly and lawfully.”

FDA Commissioner Jane Henney refused a CBS News request to answer the
allegations.

The agency’s last commissioner, Dr. David Kessler, criticized the agency’s
current approach to drug regulation.

“I have some concerns that we may be losing sight of what the FDA is all
about,” said Kessler. “The question is, who’s the agency’s customers? Who’s
the agency partner?”

Consumer advocates say the FDA is constantly keeping damaging information
from the public.

“They view the drug industry in many ways as their customers, at least the
bosses do, as opposed to viewing the public as the customers they need to
protect from some of the excesses of the drug industry,” said Sidney Wolfe of
Public Citizen.

Concerns about the FDA also emerged during the controversy over the diabetes
drug Rezulin.

Kessler said the agency needs to realize the American consumer is its
customer.

American Home Products also makes such drugs as Caordarone, Sectral,
Protonix, Synvisc and Pnu-Imune.

Fen-phen is actually a combination of two drugs, fenfluramine and
phentermine, which work by suppressing the appetite of a person who is trying
to lose weight.

It was estimated that in 1996, 18 million Americans took the drugs.

But a report in the August 1997 New England Journal of Medicine found that
fenfluramine can in some cases lead to pulmonary hypertension, a rare, almost
always fatal, disease. It was also linked to heart valve malfunction.

In September, 1997, the FDA, saying it was “acting on new evidence about
significant side-effects,” asked the manufacturers to voluntarily withdraw
both medications, marketed under the names Pondimin (fen-phen), and Redux, a
similar medication.

Wyeth-Ayerst Laboratories, a subsidiary of American Home Products, complied.

However, the company continued to deny the drugs caused the alleged problems.
In November, 1998, Wyeth-Ayerst published a study that compared heart
function in people who had taken fen-phen and a group who hadn’t, and
concluded there was “no significant differences in cardiovascular clinical
outcomes.”

But that didn’t stop the fen-phen fallout.

A February, 1999 60 Minutes II investigation with U.S. News & World Report
revealed that Wyeth-Ayerst knew more than it told about the pulmonary
hypertension risks, a charge the company denied.

In September 1999, the Wall Street Journal reported that the FBI was
investigating the FDA’s approval of Redux.

A month later, American Home Products agreed to pay up to $4.83 billion to
settle the more than 11,000 fen-phen lawsuits, one of the biggest product
liability settlements ever.

As part of the settlement agreement, the company admitted no wrongdoing.

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4/14/2000 – FDA Doc Claims Fen-Phen Cover-Up

More “hanky-panky” in the pharmaceutical industry. Did you see
this article posted this week on the CBS news site? There is a
link on our site to the class-action lawsuit suit if you or someone
you know has been effected by fen-phen. Mark

http://cbsnews.cbs.com/now/story/0,1597,181616-412,00.shtml

FDA Doc Claims Fen-Phen Cover-Up

* Says Drug Maker Altered His Findings
* Diet Drug Linked To Heart, Lung Maladies
* Company Agreed To $4.8 Billion Settlement Last Year

WASHINGTON
CBS
Fen-phen

(CBS) The drug company that manufactured “fen-phen,” a diet
medication linked to heart ailments, covered up problems with
the drug that emerged during Food and Drug Administration
testing, a former FDA scientist tells CBS News.

Fen-phen was removed from the market in 1997. Thousands of
people who took the drug have sued American Home Products
of Madison, N.J., for health problems they claim the drug caused.

In an Eye on America investigation, CBS News Correspondent
Sharyl Attkisson reports the FDA’s key reviewer of fen-phen, Dr.
Leo Lutwak, claims the company knew about the problems long
before the drug was pulled.

“I felt from the very beginning the drug companies were covering
up. I felt from the very beginning that these drugs were
dangerous,” said Lutwak.

He claims American Home Products twisted the meaning of his
research to make it seem as if there was no way to predict
fen-phen’s hazards.

“What I had actually written was, that in view of the covering up of
information by the drug company, the FDA had no way of
predicting some of these side effects,” he said.

One of those who sued American Home Products was Patricia
Buol, who developed severe heart problems after taking
fen-phen. She’s now in line for a life saving heart-lung transplant.

The company settled with Buol this week.

“Being part of my kids’ lives and doing their everyday activities is
a struggle,” said Buol. “But I just take one day at a time and do
the best I can.”

Dr. Lutwak’s testimony is crucial to fen-phen cases like Buol’s.
But the FDA won’t let him testify. Now Lutwak says he’s planning
to retire, making him free to testify at will.

“I followed the rules and regulations, I didn’t go public. I tried to
work within the system, it didn’t work. People died as a result of a
dangerous deadly drug being released,” he said.

Defendant American Home Products would not be interviewed,
but has said in the past it “acted responsibly and lawfully.”

FDA Commissioner Jane Henney refused a CBS News request
to answer the allegations.

The agency’s last commissioner, Dr. David Kessler, criticized the
agency’s current approach to drug regulation.

“I have some concerns that we may be losing sight of what the
FDA is all about,” said Kessler. “The question is, who’s the
agency’s customers? Who’s the agency partner?”

Consumer advocates say the FDA is constantly keeping
damaging information from the public.

“They view the drug industry in many ways as their customers, at
least the bosses do, as opposed to viewing the public as the
customers they need to protect from some of the excesses of the
drug industry,” said Sidney Wolfe of Public Citizen.

Concerns about the FDA also emerged during the controversy
over the diabetes drug Rezulin.

Kessler said the agency needs to realize the American
consumer is its customer.

American Home Products also makes such drugs as
Caordarone, Sectral, Protonix, Synvisc and Pnu-Imune.

Fen-phen is actually a combination of two drugs, fenfluramine
and phentermine, which work by suppressing the appetite of a
person who is trying to lose weight.

It was estimated that in 1996, 18 million Americans took the
drugs.

FDA: Under The Micriscope
Click here to read CBS News Correspondent Sharyl Attkisson’s
reports on the FDA and the diabetes drug RezulinBut a report in
the August 1997 New England Journal of Medicine found that
fenfluramine can in some cases lead to pulmonary
hypertension, a rare, almost always fatal, disease. It was also
linked to heart valve malfunction.

In September, 1997, the FDA, saying it was “acting on new
evidence about significant side-effects,” asked the
manufacturers to voluntarily withdraw both medications,
marketed under the names Pondimin (fen-phen), and Redux, a
similar medication.

Wyeth-Ayerst Laboratories, a subsidiary of American Home
Products, complied.

However, the company continued to deny the drugs caused the
alleged problems. In November, 1998, Wyeth-Ayerst published a
study that compared heart function in people who had taken
fen-phen and a group who hadn’t, and concluded there was “no
significant differences in cardiovascular clinical outcomes.”

But that didn’t stop the fen-phen fallout.

A February, 1999 60 Minutes II investigation with U.S. News &
World Report revealed that Wyeth-Ayerst knew more than it told
about the pulmonary hypertension risks, a charge the company
denied.

In September 1999, the Wall Street Journal reported that the FBI
was investigating the FDA’s approval of Redux.

A month later, American Home Products agreed to pay up to
$4.83 billion to settle the more than 11,000 fen-phen lawsuits,
one of the biggest product liability settlements ever.

As part of the settlement agreement, the company admitted no
wrongdoing.

Copyright 2000, CBS Worldwide Inc., All Rights Reserved.

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4/14/2000 – Safety Study Skimping?

This article appeared yesterday on the ABC News site. We know
that drugs are given only cursory tests before being introduced
into the marketplace. Pharmaceuticals counter that they do
extensive follow-up testing (post-marketing) to assure that the
drugs are in fact safe. Now, it appears that this is something to
which they only give lip service. Mark

http://abcnews.go.com/onair/WorldNewsTonight/wnt_000413_fd
a_feature.html

Report Says Drug Companies Fail to Complete Required Tests
When the Food and Drug Administration approves a drug it may
still have lingering questions about its safety or effectiveness
which it expects will be answered by the drug company.
(ABCNEWS.com)

By John McKenzie

N E W Y O R K, April 13 Evidence gathered by an
independent advocacy group suggests that many drug
companies in the United States are not keeping all of their
promises.

When a drug is approved by the Food and Drug Administration,
pharmaceutical firms are required to fulfill “post-marketing”
commitments to continue studying the safety and effectiveness
of the new product. Such research is necessary because the
FDA often approves drugs that have been tested on only a few
thousand people and lingering questions may remain about
how the drugs interact with other medicines or foods and what
kinds of side effects they may create in various patients.

The new study indicates, however, that many companies
routinely fail to follow through with these studies after the new
drugs reach the market. And the FDA is virtually powerless to do
anything about their lack of compliance.

The group that issued the report, Public Citizen, presented the
evidence to the FDA today, based on information obtained
through the Freedom of Information Act.

“Reliance on post-marketing studies as a way of safely
approving drugs is a dumb idea,” says Dr. Sidney Wolfe of Public
Citizen. “And a very dangerous idea because the studies mainly
are not getting done.”

Non-Compliance, No Consequences

According to Wolfe and the other authors of the report, FDA files
reveal that five drugs that were approved in the past decade and
later withdrawn from the market for safety reasons never had all
of their required follow-up studies completed.

And as of last December, only 11 out of the 88 new drugs that
were approved with post-marketing commitments between 1990
and 1994, had been subjected to the necessary studies or
properly filed the results. That€ ‘²s a compliance rate of just 13
percent.

“Five to ten years is certainly more than enough for the
overwhelming majority of these studies to be completed,” says
Dr. Brian Strom of the University of Pennsylvania. “The longer it
takes to answer these questions the longer patients are
exposed to potentially unnecessary risks.”

FDA Lacks Power

Representatives for the drug industry, however, say such studies
require greater patience.

“Specific studies that have to be designed, executed’. and if
they’re done in a comprehensive way they take a long time
to
do,” says Wayne Pines, a pharmaceutical industry spokesman.

But while the FDA can tell the drug companies to conduct
additional post-marketing studies, the fact is that once a drug is
on the market there’s little it can do to enforce the order.

Consumer advocates say Congress needs to give the FDA the
authority to impose fines on drug companies that break their
promises.

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