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 Both authors recommended that Avandia be withdrawn.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 Both authors recommended that Avandia be withdrawn.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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PAXIL: Birth Defect Case: Test Case for Over 600 Lawsuit: USA- Pennsylvania

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.”

http://www.philly.com/inquirer/business/20090912_Glaxo_trial_opens_here_Monday_in_what_could_be_Paxil_test_case.html

Posted on Sat, Sep. 12, 2009

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 birthdefect 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.

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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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DEPRESSION MED: 15 Year Old Hangs Himself: Illinois

FDA ‘black-box’ warning – In 2003, the U.S. Food and Drug Administration began warning of an increased risk of suicidal thoughts among youths taking anti-depressants. In 2004, the agency required a new, more stringent label when antidepressants were prescribed to those under 18.

Between 2003-04 the youth suicide rate jumped 14 percent
– the steepest increase ever seen – while the number of antidepressant prescriptions for youths dramatically dropped during the same period: 20 percent for children 10 and under, 12 percent for 11-to-14-year-olds and 10 percent for 15-to-19-year-olds.

Paragraphs 29 & 30 read: “He stopped going to school and began attending an outpatient program, seeing a therapist and a psychiatrist and taking medication for depression and anxiety. He tried returning to school on a half-day basis, but soon became overwhelmed with makeup work and inquiries from classmates who heard rumors he had tried to kill himself. After a few days in school, Iain asked to be readmitted to the hospital, where he stayed for a week, his parents said.”

“But as summer approached, he began showing signs of improvement. He was easier to communicate with, did his chores when asked and his doctors believed they had found the right balance in his medication, his father said.”

Paragraph 32 reads: “Lain’s parents and friends say they do not know of any incidents that might have triggered what happened June 3, when his father found him in the basement. His death was ruled a suicide by hanging, according to the Cook County Medical Examiner’s Office. He did not leave a note.”

http://www.azcentral.com/news/articles/2009/07/05/20090705bullying.html

Bullied boy’s short life ends in suicide
Jul. 5, 2009 08:20 AM
Associated Press

CHICAGO – The bullying seemed inescapable.

His family and friends say it followed Iain Steele from junior high to high school
– from hallways, where one tormentor shoved him into lockers, to cyberspace, where another posted a video on Facebook making fun of his taste for heavy metal music.

“At one point, (a bully) had told (Iain) he wished he would kill himself,” said Matt Sikora, Iain’s close friend.

Iain’s parents know their son had other problems, but they believe the harassment contributed to a deepening depression that hospitalized the 15-year-old twice this year. On June 3, while his classmates were taking final exams, he went to the basement of his home and hanged himself with a belt.

His death stunned his quiet suburb west of Chicago and unleashed an outpouring of support for his parents, William and Liz, who say greater attention should be paid to bullying and its connection to mental health.

“No kid should be afraid for himself to go to school,” his father said. “It should be a safe environment where they can intellectually thrive. And he was, literally, just frightened to go to school, fearing what he would have to deal with on that day. And it was day after day.”

A school spokeswoman said she did not believe Iain was bullied. Police are investigating the allegations.

Nearly 30 percent of American children are bullied or are bullies themselves, according to the National Youth Violence Prevention Resource Center. Bullying can be physical, verbal or psychological and is repetitive, intentional and creates a perceived imbalance of power, said Dr. Joseph Wright, senior vice president at Children’s National Medical Center in Washington.

Soon, the American Academy of Pediatrics will for the first time include a section on bullying in its official policy statement on the pediatrician’s role in preventing youth violence.

Wright, a lead author of the statement, said the decision to address the issue was due to a growing body of research over the last decade linking bullying to youth violence, depression and suicidal thoughts.

Last year, the Yale School of Medicine conducted analysis of the link between childhood bullying and suicide in 37 studies from 13 countries, finding both bullies and their victims were at high risk of contemplating suicide.

In March, the parents of a 17-year-old Ohio boy who committed suicide filed a lawsuit against his school alleging their son was bullied. Instead of seeking compensation, they are asking the school to put in place an anti-bullying program and to recognize their son’s death as a “bullicide.”

Iain Steele enjoyed riding his skateboard, his father said, but after hip surgery in 8th grade limited his mobility, he picked up the guitar and impressed an instructor with his musical talent.

He was revered by younger kids in the neighborhood, often fixing their skateboards, settling their disputes and including them in games. “He was a very gentle, kind kid, compassionate to a fault,” his father said. But Iain’s embrace of heavy metal set him apart from classmates. He let his hair grow to shoulder-length and wore mostly black clothing, including jeans with chains and T-shirts of heavy metal bands with dark, sometimes morbid lyrics.

For this, his classmates at McClure Junior High School often called him “emo” – a slang term for angst-ridden followers of a style of punk music, said Sikora, 15.

The bullying could also be physical, Iain’s friends and parents said. In 8th grade at McClure, one bully pushed Iain into a locker while he was on crutches and accused him of faking an injury to get out of gym class. Iain rarely shied away from his tormentors, however, and in this case, he punched the bully in the jaw, his father said.

“He was mainly bullied only because he was different, or hurt, or stupid things like that,” said Sikora. “He never bothered anybody. … It was all just because he was different and an easy target.”

William Steele said his son had trouble ignoring the bullying because it “was just sort of relentless.” It got to the point where the father sat down with the principal at McClure and with a bully’s mother. But the harassment did not subside.

Steele said, “(Iain) had a real trust issue because he felt like, particularly at McClure, the system let him down, that it didn’t deliver on its promise to protect him from bullying.”

McClure Principal Dan Chick said in an e-mail “the District 101 community is deeply saddened by this recent tragedy of losing one of our children.” Chick said he takes bullying very seriously but declined to discuss details of Iain’s case because of privacy issues.

“As with all situations, I investigated this specific matter and took appropriate actions within the limits of my authority,” Chick said.

After graduating from McClure in 2008, Iain began attending the south campus for freshmen and sophomores at Lyons Township High School, where he found new friends – and new tormentors. A new bully emerged who at first acted friendly but then posted a homemade video on Facebook pretending to be Iain playing heavy metal on guitar.

“It was like a public humiliation to (Iain),” Sikora said.

The family of the student did not respond to requests for comment.

Jennifer Bialobok, a spokeswoman for Lyons Township High School, said “bullying is obviously not tolerated at LT,” but added, “I don’t think we’re naive enough to think that bullying behavior doesn’t exist.”

Two years ago, Lyons Township created a “speak up line” in which students can anonymously report “inappropriate or unsafe behavior,” and the school hangs posters defining bullying and explaining how to report it, Bialobok said. If any student reported being bullied, a thorough investigation would take place, with consequences ranging from parental notification to out-of-school suspension, she said.

Bialobok said she could not discuss Iain’s case because of student privacy laws, but, “we don’t believe that bullying was an issue while Iain was attending LT. Counselors and a host of other support personnel worked routinely to make his experience at LT a positive one.”

Local police have not documented incidents of bullying involving Iain but are still conducting interviews, Deputy Chief Brian Budds said.

By this winter, Iain’s mental health had begun a downward spiral, his parents said. In February, he told them he was having suicidal thoughts and asked to be admitted to the hospital.

He stopped going to school and began attending an outpatient program, seeing a therapist and a psychiatrist and taking medication for depression and anxiety. He tried returning to school on a half-day basis, but soon became overwhelmed with makeup work and inquiries from classmates who heard rumors he had tried to kill himself. After a few days in school, Iain asked to be readmitted to the hospital, where he stayed for a week, his parents said.

But as summer approached, he began showing signs of improvement. He was easier to communicate with, did his chores when asked and his doctors believed they had found the right balance in his medication, his father said.

“He seemed to be in a calm, happy place,” he said.

Iain’s parents and friends say they do not know of any incidents that might have triggered what happened June 3, when his father found him in the basement. His death was ruled a suicide by hanging, according to the Cook County Medical Examiner’s Office. He did not leave a note.

Looking back, Iain’s parents wonder what factors besides bullying may have contributed to their son’s depression.

Iain’s favorite heavy metal bands, such as Lamb of God and Children of Bodem and Bullet for My Valentine, often have lyrics with dark messages. One Bullet for My Valentine song is about being bullied, and another song contains the refrain: “The only way out is to die.”

Also, Iain was deeply hurt this spring after a brief relationship with a girl he met in his outpatient program. The two exchanged text messages, but her parents and therapists advised against them dating and about two months ago barred her from having communication with him.

Still, Iain’s parents remain convinced bullying played a significant role in their son’s depression. As Iain’s story spread through the community, many people approached Liz Steele to describe their own experiences with bullying, depression or suicide, she said.

“A lot of people don’t want to talk about mental health or bullying because it’s a difficult thing to talk about, but we need to talk about it,” she said. “It shouldn’t be a stigma.”

Meanwhile, the community has rallied behind the Steeles. In Iain’s memory, his classmates tied white ribbons around hundreds of trees in the neighborhood. On June 10, about 500 people attended a memorial service at First Congregational Church of Western Springs.

Rich Kirchherr, senior minister at the church, said the community has felt a “deep and abiding sadness” since Iain’s death. Kirchherr said few people seemed aware that Iain was bullied.

“There is an acknowledgment now, as people have discovered that Iain might not always have been treated with the respect that every person deserves,” Kirchherr said. “Many people were surprised to hear that.”

Friends have established several Facebook groups in his memory, including the “Iain Steele Remembrance Group,” which has more than 700 members. The commentary on the group’s wall was summed up by a Lyons Township High School student who said she did not know Iain but had learned an important lesson from his death.

“I’m learning to treat everyone with respect, even people who I don’t know well or people who I might not get along with,” she wrote. “If there is anything good that can come out of this tragedy, the responsibility lies with us to live with kindness and be aware that life is fragile.”

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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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12/29/2000 – FDA’s Expedited Drug Approvals Cost Lives

Please excuse the flood of new information. I have
been on the road lecturing for the last six months or
so and have several e-mails that have been waiting
for me to send them out to you.

Keep in mind as you read this article that the SSRI
antidepressants were among the first to be approved
after the expidited drug approvals began. If anyone
thinks these seven drugs have been deadly(and they
have taken a terrible toll while bringing in billions for
the drug companies), just wait until the death toll
comes in on the SSRIs!

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

FDA’s Expedited Drug Approvals Cost Lives

“They’ve lost their compass and they forget who it is that they are
ultimately serving,” said Lemuel Moye, a University of Texas School of Public
Health physician who served from 1995 to 1999 on an FDA advisory committee.
“Unfortu- nately the public pays for this, because the public believes that
the FDA is watching the door, that they are the sentry.”

Friday, December 29, 2000

BY DAVID WILLMAN
LOS ANGELES TIMES

WASHINGTON — For most of its history, the U.S. Food and Drug
Administration approved new prescription medicines at a grudging pace, paying
daily homage to the physician’s creed, “First, do no harm.”
Then in the early 1990s, the demand for AIDS drugs changed the political
climate. Congress told the FDA to work closely with pharmaceutical companies
in getting new medicines to market more swiftly. President Clinton urged FDA
leaders to trust industry as “partners, not adversaries.”
The FDA achieved its new goals, but now the human cost is becoming clear.
Seven drugs approved since 1993 have been withdrawn after reports of
deaths and severe side effects. A two-year Los Angeles Times investigation
has found that the FDA approved each of those drugs while disregarding danger
signs or blunt warnings from its own specialists. Then, after receiving
reports of significant harm to patients, the agency was slow to seek
withdrawals.
According to “adverse-event” reports filed with the FDA, the seven drugs
were cited as suspects in 1,002 deaths. Because the deaths are reported by
doctors, hospitals and others on a voluntary basis, the true number of
fatalities could be far higher, according to epidemiologists.
An adverse-event report does not prove that a drug caused a death; other
factors, such as pre-existing disease, could play a role. But the reports are
regarded by public health officials as the most reliable early warnings of
danger.
The FDA’s performance was tracked through an examination of thousands of
pages of government documents, other data obtained under the Freedom of
Information Act and interviews with more than 60 present and former agency
officials.

Not Needed to Save Lives: The seven drugs were not needed to save lives.
One was for heartburn. Another was a diet pill. A third was a painkiller. All
told, six of the medicines were never proven to offer lifesaving benefits,
and the seventh, an antibiotic, was ultimately judged unnecessary because
other, safer antibiotics were available.
The seven are among hundreds of new drugs approved since 1993, a period
during which the FDA has become known more for its speed than its caution. In
1988, only 4 percent of new drugs introduced into the world market were
approved first by the FDA. In 1998, the FDA’s first-in-the-world approvals
spiked to 66 percent.
The drug companies’ batting average in getting new drugs approved also
climbed. By the end of the 1990s, the FDA was approving more than 80 percent
of the industry’s applications for new products, compared with about 60
percent at the beginning of the decade.
And the companies have prospered: The seven unsuccessful drugs alone
generated U.S. sales exceeding $5 billion before they were withdrawn.
Once the world’s unrivaled safety leader, the FDA was the last to
withdraw several new drugs in the late 1990s that were banned by health
authorities in Europe.
“This track record is totally unacceptable,” said Curt Furberg, a
professor of public health sciences at Wake Forest University. “The patients
are the ones paying the price. They’re the ones developing all the side
effects, fatal and non-fatal. Someone has to speak up for them.”

Fatal Missteps: The FDA’s faster and more lenient approach helped supply
pharmacy shelves with scores of new remedies. But it has also yielded these
fatal missteps, according to the documents and interviews:
— Only 10 months ago, FDA administrators dismissed one of its medical
officer’s emphatic warnings and approved Lotronex, a drug for treating
irritable bowel syndrome. Lotronex has been linked to five deaths, the
removal of a patient’s colon and other bowel surgeries. It was pulled off the
market Nov. 28.
— The diet pill Redux, approved in April 1996 despite an advisory
committee’s vote against it, was withdrawn in September 1997 after
heart-valve damage was detected in patients put on the drug. The FDA later
received reports identifying Redux as a suspect in 123 deaths.
— The antibiotic Raxar was approved in November 1997 in the face of
evidence that it may have caused several fatal heart-rhythm disruptions in
clinical studies. FDA officials chose to exclude any mention of the deaths
from the drug’s label. The maker of the pill withdrew it in October 1999.
Raxar was cited as a suspect in the deaths of 13 patients.
— The blood pressure medication Posicor was approved in June 1997
despite findings by FDA specialists that it might fatally disrupt heart
rhythm and interact with certain other drugs, posing potentially severe risk.
Posicor was withdrawn one year later; reports cited it as a suspect in 100
deaths.
— The painkiller Duract was approved in July 1997 after FDA medical
officers warned repeatedly of the drug’s liver toxicity. Senior officials
sided with the manufacturer in softening the label’s warning of the liver
threat. The drug was withdrawn 11 months later. By late 1998, the FDA had
received voluntary reports citing Duract as a suspect in 68 deaths, including
17 that involved liver failure.
— The diabetes drug Rezulin was approved in January 1997 over a medical
officer’s detailed opposition and was withdrawn last March after the agency
had linked 91 liver failures to the pill. Reports cite Rezulin as a suspect
in 391 deaths.
— The nighttime heartburn drug Propulsid was approved in 1993 despite
evidence that it caused heart-rhythm disorders. The officials who approved
the drug failed to consult the agency’s own cardiac specialists about the
signs of danger. The drug was taken out of pharmacies in July after scores of
confirmed heart-rhythm deaths. Overall, Propulsid has been cited as a suspect
in 302 deaths.
The FDA’s handling of Propulsid put children at risk.
The agency never warned doctors not to administer the drug to infants or
other children even though eight youngsters given Propulsid in clinical
studies had died. Pediatricians prescribed it widely for infants afflicted
with gastric reflux, a common digestive disorder.
Parents and their doctors had no way of knowing that the FDA, in August
1996, had found Propulsid to be “not approvable” for children.
By the time the drug was pulled, the FDA had received reports of 24 deaths
of children under age 6 who were given Propulsid. By then the drug had
generated U.S. sales of $2.5 billion for Johnson & Johnson Co.
Questions also surround the recent approvals of other compounds that
remain on the market, including a new flu drug called Relenza. In February
1999, an FDA advisory committee concluded that Relenza had not been proven
safe and effective. The agency nevertheless approved it. After the deaths of
seven patients, the FDA last January issued a “public health advisory” to
doctors.
A total of 10 drugs have been pulled from the market in just the past
three years for safety reasons, including three pills that were approved
before the shift that took hold in 1993. Never before has the FDA overseen
the withdrawals of so many drugs in such a short time. More than 22 million
Americans — about 10 percent of the nation’s adult population — took those
drugs.
With many of the drugs, the FDA used tiny-print warnings or
recommendations in package labeling as a way to justify approvals or stave
off withdrawals. In other instances, the agency has withheld safety
information from labels that physicians say would call into question the use
of the product.

Lost Compass? Present and former FDA specialists said the regulatory
decisions of senior officials have clashed with the agency’s central
obligation, under law, to “protect the public health by ensuring . . . that
drugs are safe and effective.”
“They’ve lost their compass and they forget who it is that they are
ultimately serving,” said Lemuel Moye, a University of Texas School of Public
Health physician who served from 1995 to 1999 on an FDA advisory committee.
“Unfortu- nately the public pays for this, because the public believes that
the FDA is watching the door, that they are the sentry.”
The FDA’s shift is felt directly in the private practice of medicine,
said William Isley, a Kansas City, Mo., physician specializing in diabetes.
He implored the agency to reassess Rezulin three years ago after a patient he
treated suffered liver failure taking the pill.
“FDA used to serve a purpose,” Isley said. “A doctor could feel sure that
a drug he was prescribing was as safe as possible. Now you wonder what kind
of evaluation has been done, and what’s been swept under the rug.”

Withdrawals’ Consequences: FDA officials said they have tried
conscientiously to weigh benefits vs. risks in deciding whether to approve
new drugs. They noted that many doctors and patients complain when a drug is
withdrawn.
“All drugs have risks; most of them have serious risks,” said Janet
Woodcock, director of the FDA’s drug-review center. She added that some of
the withdrawn drugs were “very valuable, even if not lifesaving, and their
removal from the market represents a loss, even if a necessary one.”
Once a drug is proven effective and safe, Woodcock said, the FDA depends
on doctors “to take into account the risks, to read the label. . . . We have
to rely on the practitioner community to be the learned intermediary. That’s
why drugs are prescription drugs.”
In a May 12, 1999, article co-authored with FDA colleagues and published
by the Journal of the American Medical Association, Woodcock said, “The FDA
and the community are willing to take greater safety risks due to the serious
nature of the [illnesses] being treated.”
Compared to the volume of new drugs approved, they wrote, the number of
recent withdrawals “is particularly reassuring.”
However, agency specialists point out that both approvals and withdrawals
are controlled by Woodcock and her administrators. When they consider a
withdrawal, they face the unpleasant prospect of repudiating their original
decision to approve.
Woodcock, 52, received her medical degree at Northwestern University and
is a board-certified internist. She alluded in a recent interview to the
difficulty she feels in rejecting a proposed drug that might cost a company
$150 million or more to develop. She also acknowledged the commercial
pressures in a March 1997 article.
But last summer — following the eighth and ninth drug withdrawals —
Woodcock said the FDA cannot rely on labeling precautions, alone, to resolve
safety concerns.
“As medical practice has changed . . . it’s just much more difficult for
[doctors] to manage” the expanded drug supply, Woodcock said in an interview.
Yet the imperative to move swiftly, cooperatively, remains.
“We are now making decisions more quickly and more predictably while
maintaining the same high standards for product safety and efficacy,” FDA
Commissioner Jane Henney said in a National Press Club speech on Dec. 12.

The Role of AIDS: The impetus for change at the FDA emerged in 1988, when
AIDS activists paralyzed operations for a day at the agency’s 18-story
headquarters in Rockville, Md. They demanded immediate approval of
experimental drugs that offered at least a ray of hope to those otherwise
facing death.
The FDA often was taking more than two years to review new drug
applications. The pharmaceutical industry saw a chance to loosen the
regulatory brakes and expedite an array of new products to market. The
companies and their Capitol Hill lobbyists pressed for advantage: If
unshackled, they said, the companies could invent and develop more remedies
faster.
The political pressure mounted, and the FDA began to bow. By 1991, agency
officials told Congress they were making significant progress in speeding the
approval process.
The emboldened companies pushed for more. They proposed that drugs
intended for either life-threatening or “serious” disorders receive a quicker
review.
“The pharmaceutical companies came back and lobbied the agency and the
Hill for that word, ‘serious,’ ” recalled Jeffrey Nesbit, who in 1991 was
chief of staff to FDA Commissioner David Kessler.
In 1992, Kessler issued regulations giving the FDA discretion to
“accelerate approval of certain new drugs” for serious or life-threatening
conditions. That same year a Democrat-controlled Congress approved and
then-President Bush signed the Prescription Drug User Fee Act. It established
goals that call for the FDA to review drugs within six months or a year; the
pharmaceutical companies pay a user fee to the FDA, now $309,647, with the
filing of each new drug application.

Reinventing Government: The newly elected Clinton administration climbed
aboard with its “reinventing government” project. Headed by Vice President Al
Gore, the project called for the FDA, by January 2000, to reduce “by an
average of one year the time required to bring important new drugs to the
American public.” As Clinton put it in a speech on March 16, 1995, the
objective was to “get rid of yesterday’s government.”
For the FDA’s medical reviewers — the physicians, pharmacologists,
chemists and biostatisticians who scrutinize the safety and effectiveness of
emerging drugs — a new order had taken hold.
The reviewers work out of public view in secure office buildings
clustered along Maryland’s Route 355. They examine truckloads of scientific
documents. They are well-educated; some are highly motivated to do their best
for a nation of patients who unknowingly count on their expertise.
One of these reviewers was Michael Elashoff, a biostatistician who
arrived at the FDA in 1995 after earning degrees from the University of
California, Berkeley, and the Harvard School of Public Health.
“From the first drug I reviewed, I really got the sense that I was doing
something worthwhile. I saw what a difference a single reviewer can make,”
said Elashoff, the son and grandson of statisticians.
Last year he was assigned to review Relenza, the new flu drug developed
by Glaxo Wellcome. He recommended against approval, citing a lack of proven
effectiveness and potential risks.
An agency advisory committee agreed and on Feb. 24 voted 13-4 against
approving Relenza.
After the vote, senior FDA officials upbraided Elashoff. They stripped
him of his review of another flu drug. They told him he would no longer make
presentations to the advisory committee. And they approved Relenza as a safe
and effective flu drug.
Elashoff and other FDA reviewers discern a powerful message.
“People are aware that turning something down is going to cause problems
with [officials] higher up in FDA, maybe more problems than it’s worth,” he
said.
Elashoff left the FDA four months ago.
In 1994, the FDA’s goal was to finish 55 percent of its new drug reviews
on time; the agency achieved 95 percent. In both 1997 and 1998, the goal was
90 percent and the FDA achieved 100 percent.
From 1993-99 the agency approved 232 drugs regarded as “new molecular
entities,” compared with 163 during the previous seven years, a 42 percent
increase.
The time-limit goals quickly were treated as deadlines within the FDA —
imposing relentless pressure on reviewers and their bosses to quickly
conclude their work and approve the drugs.
“The goals were to be taken seriously. I don’t think anybody expected the
agency to make them all,” said William Schultz, a deputy FDA commissioner
from 1995 to 1999.
Schultz, who helped craft the 1992 user-fee act as a congressional staff
lawyer, added: “You can meet the goal by either approving the drug or denying
the approval. But there are some who argue that what Congress really wanted
was not just decisions, but approvals. That is what really gets dangerous.”
The user fees have enabled the FDA to hire more medical reviewers. Last
year, 236 medical officers examined new drugs compared with 162 officers on
duty in 1992, the year before the user fees took effect.

‘A Sweatshop Environment’: Even so, Woodcock acknowledged in an FDA
publication last fall that the workloads and tight performance goals “create
a sweatshop environment that’s causing high staffing turnover.”
Dozens of officials interviewed by the Times made similar observations.
The perception of coziness with drug makers is perpetuated by potential
conflicts of interest within the FDA’s 18 advisory committees, the
influential panels that recommend which drugs deserve approval or should
remain on the market. The FDA allows some appointees to double as consultants
or researchers for the same companies whose products they are evaluating on
the public’s behalf. Such was the case during committee appraisals of several
of the recently withdrawn drugs, including Lotronex and Posicor, the Times
found.
Few doubt the $100 billion pharmaceutical industry’s clout. Over the last
decade, the drug companies have steered $44 million in contributions to the
major political parties and to candidates for the White House and both houses
of Congress.
The FDA reviewers said they and their bosses fear that unless the new
drugs are approved, companies will erupt and Congress will retaliate by
refusing to renew the user fees. This would cripple FDA operations — and
jeopardize jobs.
Yet even if the user fees remain, the FDA is prohibited from spending the
revenue for anything other than reviewing new drugs. So while the budget for
pre-approval reviews has soared, the agency has gotten no similar increase of
resources to evaluate the safety of the drugs after they are prescribed.
Leading industry officials say Americans have nothing to fear from the
wave of drug approvals.
“Do unsafe drugs enter and remain in the marketplace? Absolutely not,”
said Bert Spilker, senior vice president for scientific and regulatory
affairs for the Pharmaceutical Research and Manufacturers of America, in
remarks last year to industry and FDA scientists.
But during interviews over the last two years, current and former FDA
specialists cited repeated instances when drugs were approved with less than
compelling evidence of safety or effectiveness. They also said that important
information has been excluded from the labels on some medications.

Salt Lake Tribune, December 29, 2000, pg. A10

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12/29/2000 – Sarafem Nation – Renamed Prozac Targets Huge Market: Premenstrual W

http://www.villagevoice.com/issues/0049/spartos.shtml

Published December 6 – 12, 2000

Renamed Prozac Targets Huge Market: Premenstrual Women

Sarafem Nation

by Carla Spartos

A visibly irritated woman yanks on a supermarket shopping cart that’s stuck
in its stack while a soothing female voice-over recites a litany of PMS
symptoms. She asks, “Think it’s PMS? Think again. . . . It could be PMDD.”

Premenstrual Dysphoric Disorder, or PMDD, is a fresh-minted mental illness
that purportedly affects 3 to 10 percent of all menstruating women. Mood
symptoms like depression, anxiety, anger, irritability, or sensitivity to
rejection are said to be so severe the week before a woman’s period that it
impairs her functioning. According to Dr. Jean Endicott, professor of
clinical psychology at Columbia University’s College of Physicians and
Surgeons, “What’s ordinarily irritating becomes enraging.”

To be diagnosed with PMDD, women must keep a daily diary of their symptoms
for the duration of two menstrual cycles. The symptoms must kick in after
ovulation and disappear once menstruation begins. “The timing is exquisite,”
remarks Endicott.

The timing is also exquisite for Eli Lilly and Company to make a financial
killing off of PMDD. Next year, the drug company will lose its patents on the
antidepressant Prozac, and with them its monopoly on the market. To ward off
declining profits, Lilly has found another use for its wonder drug—treating
PMDD.

In July, Lilly got Food and Drug Administration approval to market Prozac
under the new name Sarafem. The company is packaging the drug in pretty pink
and lavender capsules, exclusively for women, most in their late twenties or
early thirties. Says Laura Miller, a spokesperson for Lilly, “Women told us
they wanted treatment that would differentiate PMDD from depression.”

According to Endicott, the symptoms of PMDD primarily interrupt
“interpersonal relationships”—basically, those involving spouses, children,
and coworkers. In one group of women with self-described premenstrual
symptoms, researchers found no increase in absenteeism or decline in work
performance, although the women themselves perceived that to be the case.

“PMDD is unique because there is virtually no other disease that people
insist upon having,” says Dr. Nada Stotland, chair of psychiatry at Illinois
Masonic Medical Center. According to Stotland, the majority of women who go
to PMS clinics have symptoms that aren’t in fact related to their periods.
“Most are depressed everyday. Others have anxiety and personality disorders.
Some are in psychological pain because they are being abused.”

That women might seek help on the pretense their problems are hormonally
based makes PMDD more slippery to recognize and study. Stotland says she’s
particularly concerned that Lilly is targeting almost exclusively OB-GYNs as
Sarafem prescribers, which puts gynecologists in the position of treating
mental illness. She says Lilly’s advertising campaign may convince enough
women they need Sarafem, leading them to pressure their doctors to skip the
two months needed for diagnosis and instead send them straight to the
pharmacy. And since Sarafem will also work for those with chronic depression,
a misdiagnosis can go undetected.

Proponents of Sarafem downplay the potential for misuse. “I doubt that a lot
of people who don’t need the treatment would get it,” argues Endicott.
“First, it’s a prescription drug. Second, women are not big pill poppers.”
Sherry Marts, scientific director of the Society for Women’s Health
Research—a nonprofit organization that promotes research in women’s health
issues—concurs. “This is a real medical condition that requires treatment for
a small percentage of women,” she says.”Not, ‘I’m a little bloated, I’m gonna
pop some Prozac.’ ”

But critics claim that 3 to 10 percent of all menstruating women is no small
number. “That’s a minimum of half a million North American women suffering
from PMDD,” says Paula Caplan, a psychologist and affiliated scholar at Brown
University’s Pembroke Center for Research and Teaching on Women.

Whether PMDD is a real condition is still subject to debate. Although both
sides agree that a certain subset of women may be sensitive to normal
hormonal changes, that’s about all they agree on. The question remains, if
women sometimes snap at their husbands if they don’t pick up after
themselves, or at their kids if they do poorly in school, should they be
branded with a mental disorder? “Women are commonly in situations defined by
stress—responsibility without authority,” says Stotland. ‘That’s almost the
definition of a typical woman’s job.”

Some doctors fear that women who have legitimate reasons to be unhappy will
be silenced by the PMDD diagnosis, and that Sarafem could prove to be the
Valium of the naughts. “Ordinary, healthy changes in mood and emotion are
being pathologized when they happen to women, and since women believe they
shouldn’t feel irritable, angry, or depressed, they are quick to blame
themselves,” says Caplan. For men, “There’s no testosterone-based aggressive
disorder.”

Endicott disagrees. “If men had PMDD, it would have been studied a long time
ago.”

But would it? “To say that a huge proportion of the female population is
disabled represents a potentially horrendous setback for women in the
workplace,” says Stotland. She points to the woman who finally speaks up to
her boss and in return is asked, “Oh, is it that time of the month?” Agreeing
to that kind of put-down might save the woman her job. PMDD could reinforce
the stereotype of the hysterical woman not only to employers, but to women
themselves.

Caplan says that a diagnosis of PMDD will have far-reaching legal
implications as well. Might women who’ve been labeled as mentally ill be
deprived of the right to make their own decisions? Might they lose custody of
their children in divorce cases? In other words, will PMDD sufferers be seen
as the biological equivalent of Dr. Jekyll and Mr. Hyde?

That’s already the most common complaint of PMDD sufferers, says Endicott,
who reports women saying over and over, “This isn’t me.” Lilly promotional
literature echoes this sentiment. “The good news is there is treatment
available that can help you feel more like the woman you are every day of the
month,” the brochures say. But who is this woman? And why are we so concerned
with her hormones?

——————————————————————————

One thing is for sure: Eli Lilly and Company has a financial stake in PMDD.
Lilly’s Prozac patents are expiring in 2001 and 2003. This means the market
will open up to cheaper generic competitors. Analysts have estimated that
Prozac sales will decline drastically—from about $2.51 billion in 2000 to
$625 million in 2003. Sarafem will provide a significant new market—women—to
boost profits. That’s a smart move, since women are the primary users of
drugs that alter mood. And, according to documents posted on the FDA’s Web
site, Lilly has proposed a “pilot study of PMDD in adolescents to estimate
its response to treatment with fluoxetine.” Fluoxetine, by the way, is the
generic name for Sarafem (and Prozac).

Another plus for Lilly is that creating a new and separate trademark for
Prozac lessens the stigma associated with antidepressants, and lets the
company dodge some recent bad press, from the publication of Harvard’s Joseph
Glenmullen’s Prozac Backlash to a new study in Brain Research that suggests
the antidepressant may cut off axons of the nerves they target—in effect
causing brain damage.

By 2004, Sarafem sales are expected to climb to $250 million a year,
according to Bear Stearn’s Bottle Report. Lilly would not divulge projected
sales nor the amount of money spent marketing, researching, and developing
Sarafem, but their financial report shows a lot of zeroes. For the first
three quarters of this year, the corporation spent close to $2.3 billion in
marketing and administrative costs, much more than its research and
development, which totalled about $1.5 billion.

But most extraordinary is that the federal government is convinced of the
existence of PMDD, while the psychiatric community isn’t so sure at all. PMDD
is currently listed in the appendix of the DSM-IV—the psychiatrist’s bible of
mental illnesses—as “needing further study.”

The controversy began in 1987, when the compendium first included specific
criteria for Late Luteal Phase Dysphoric Disorder—the former name for
PMDD—in its appendix as a “proposed diagnostic category” needing more
research. In 1993, as the American Psychiatric Association’s task force was
compiling the fourth edition of the manual, the category was revisited.
Should it remain in the appendix, get moved to the body as a recognized
diagnostic category, or be removed altogether?

The committee decided to keep PMDD in the appendix. According to Psychiatric
News, the APA’s professional newsletter, “Members of the task force agreed
there were a number of problems with methodology within the PMDD literature.
The problems included unclear definitions, small sample sizes, lack of
control groups, lack of prospective daily ratings of symptoms, no
documentation of the timing and duration of symptoms, and failure to collect
appropriate hormonal samples.” However, the committee suggested specific
criteria for diagnosing PMDD, including specs for symptoms and timing.

Five years later, the fate of PMDD was still unclear. In October 1998, the
Society for Women’s Health Research organized a discussion, headed by
Endicott, to answer this question: “Is premenstrual dysphoric disorder a
distinct clinical entity?” Once again, experts reviewed the PMDD literature,
this time in the company of FDA and Lilly representatives.

Dr. Sally Severino, a now retired professor of psychiatry at the University
of New Mexico, reiterated flaws in the research. First, just because women
can be identified by PMDD criteria “is not proof that PMDD exists as a valid
diagnosis.” Second, although cross-cultural studies identified physical
complaints related to menstruation, mood symptoms like anger and irritability
were not found worldwide to the same degree as in America. Severino argued
that if PMDD can’t be identified in other populations, then “consideration
must be given to the criticism that PMDD is a culturally bound syndrome or an
unnecessary pathologizing of cyclical changes in women.”

Ignoring these objections, the round table concluded that PMDD was a
“distinct entity with clinical and biologic profiles dissimilar to those seen
in other disorders.” In other words, a mental illness.

What changed between 1993 and 1998? For one thing, Lilly funded a 1995 study
that showed Prozac was effective in treating PMDD. Published in The New
England Journal of Medicine, the study had a large sample size, and was
placebo-controlled and double-blind (meaning neither the doctor nor the
participant knows who’s getting drugs or a sugar pill)—all the makings of a
pristine scientific inquiry. A slate of studies followed suit, all with the
same results: About 60 percent of women diagnosed with PMDD respond to
Prozac.

Yet one 1998 study discussed by Endicott’s roundtable found that 55 percent
of women diagnosed with premenstrual symptoms got significant relief from
increased calcium intake. The group went on to comment that “the area of
calcium is not well explored.” That leads critics to wonder why other
treatment options are getting the cold shoulder. “Why not spend pages and
pages pushing calcium?” asks Caplan, who served on the 1993 DSM committee.
And although there is evidence that people with PMDD can feel better with
only intermittent doses of Prozac—and suffer fewer side effects like sexual
dysfunction—the studies Lilly presented to the FDA looked solely at the
effectiveness of daily doses, or roughly double the amount some researchers
say is needed.

According to Caplan, almost all of the data the roundtable evaluated fell
into two categories: the old problematic studies available to the DSM-IV
group or the new research into using Prozac to treat PMDD. “There was nothing
that looked at the validity of the PMDD construct,” says Caplan.

Did Lilly railroad Sarafem through? Two members of the 16-person roundtable
conducted PMDD research funded by Lilly, and another member has received
honoraria as a speaker for Lilly. Endicott, who hasn’t received research
funds or speaking fees from Lilly, opened the company’s November 1999
presentation to an FDA advisory committee, which voted unanimously in favor
of the new PMDD indication for Prozac. In addition, the Society for Women’s
Health Research trumpets on its Web site an “unrestricted educational grant
from Eli Lilly and Company,” which they’ve used to promote PMDD awareness,
including a national survey conducted in November to gauge women’s awareness
of PMDD and available treatment (i.e., Sarafem). “Lilly had done an
extraordinary job of getting this to the public,” says Stotland.

Researchers taking a ride on the drug-company gravy train is not unique to
those who studied PMDD, but it can have effects on scientific research. “I
don’t think people falsify results. But what kinds of questions do you ask?
Which results do you publish?” asks Stotland. “When I was a resident it was
the departments who had money to bring in speakers. Now, it’s the drug
companies who are flying people around.”

Incidently, at the time of the interview, Stotland was attending a PMDD
conference held at a Palm Springs resort, courtesy of Eli Lilly.

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10/09/2000 – Congressman attributes son’s suicide to Accutane

msnbc.com

Lawmaker tells of acne drug’s risk

Rep. Bart Stupak.

NBC’s Dr. Bob Arnot discusses the possible health risks of Accutane and
alternative treatments for severe cases of acne.

Congressman attributes
son’s suicide to Accutane

MSNBC STAFF AND WIRE REPORTS

TRAVERSE CITY, Mich., Oct. 5. A Michigan congressman whose
17-year-old son committed suicide earlier this year went public Thursday with
criticism of the Food and Drug Administration, charging on NBC’s Today
show that the agency had failed to warn consumers that the popular acne
medicine Accutane may cause depression.

If it can happen to our family it certainly can happen to you, and we
don’t want anyone to have to go through that. REP. BART STUPAK

BART STUPAK JR., known as B.J., shot himself in the head with his
father’s gun in the early hours of May 14. Stupak, a popular football player,
killed himself after a prom-night party.

His father, Rep. Bart Stupak, a four-term Democrat from Menominee,
said Thursday that he blames Accutane, a powerful acne drug B.J. had taken
for six months prior to his death. We knew our son, we loved our son, he
said.

The congressman and his wife, Laurie, said they had considered every
possible explanation for B.J.’s suicide and the only thing we can find is
Accutane.

FDA ADVISORY

In 1998, the Food and Drug Administration advised doctors who
prescribe Accutane to watch their patients for signs of depression.
Afterward, the company notified doctors that the drug may cause depression,
psychosis, and, rarely, suicidal ideation, suicide attempts and suicide.

But Stupak said the FDA had done a poor job spreading the word. B.J.’s
medication package included no warning and the doctor didn’t tell the parents
about the link to depression, his father said.

If it can happen to our family it certainly can happen to you, and we
don’t want anyone to have to go through that, Stupak said.

Hoffmann-La Roche, which manufactures Accutane, contends no
link has been proven between the drug and depression or suicide. In 1998, the
company argued that more than 4 million Americans have taken Accutane since
it was approved in 1982, and the possible side effect is very rare. It said
teen-agers, prime acne sufferers, often suffer depression, and hormones
involved with acne also may contribute to depression.

B.J.’s death stunned family and friends. In the Today interview,
his parents said he was a happy young man with a bright future.

COMPLETELY OUT OF CHARACTER

This is contrary to everything he lived for, everything he thought,
everything he wanted in life … completely out of character for him, Stupak
said. He would not do something like this.

B.J. left no note and the autopsy showed no drugs in his system,
although he apparently had taken a couple of drinks.
Advertisement

The only suggestion of odd behavior came the night before his death.
During a party following his junior prom, B.J. began reading the Bible and
said he wasn’t going to college because of his grades, and that his parents
probably hated him for that, according to an account on the Today program.
The Stupaks said there was no reason for him to think such a thing.

An FDA science advisory panel last month suggested requiring
Hoffman-LaRoche to give patients information about potential risks, agency
drug chief Janet Woodcock said.

INSUFFICIENT DATA

But Woodcock said there still was insufficient data to establish a
definite connection between Accutane and depression or suicide.

It’s really hard to nail this down, she said in a telephone
interview Wednesday. The bottom line is there is evidence against there
being a link and evidence for being a link.

During the advisory panel meeting, FDA staffers presented evidence
that some people had become depressed when taking the drug and had gotten
over their depression after stopping use of the drug, Woodcock said.

But experts for Hoffman-LaRoche countered with evidence suggesting no
link, she said. The committee recommended further study.

The Associated Press contributed to this report.

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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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