Bristol-Myers Squibb to pay $515 million for doctor kickback scheme
Source: Boston Globe
Bristol-Myers Squibb Company and its subsidiary, Apothecon, have agreed to pay more than $515 million to settle a broad array of federal and state civil allegations involving their drug marketing and pricing practices, US Attorney Michael J. Sullivan said today.
The government alleged that from 2000 to mid-2003, BMS paid illegal remuneration to physicians and other healthcare providers to get them to promote BMS drugs. The payments were in the form of consulting fees and other programs, some of which involved travel to luxurious resorts.
The prosecutors also said that from 2002 through 2005 BMC promoted the sale and use of Abilify, an atypical antipsychotic drug, for pediatric use and to treat dementia-related psychosis, both of which were "off-label'' uses. The US Food and Drug Administration has approved the drug to treat adult psychiatric disorders but not for use in children, teenagers, or for dementia-related illnesses.
Doctors are allowed to prescribe drugs "off-label,'' but companies are not allowed to promote drugs for those uses.
Sullivan said his office is not bringing criminal charges and that the company cooperated with the investigation, which was prompted by information from whistleblowers.
In a statement posted on its website, the company said the settlement agreement will not affect the company's ongoing business with any customers, including the government.
"Bristol-Myers Squibb is pleased to have resolved these matters from the past and is proud of its commitment to conduct business with the highest standards of integrity in its mission to extend and enhance human life,'' the company said.
Zantac Lawsuit
Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Saturday, September 29, 2007
Monday, September 24, 2007
Request for victims to testify about their secret settlement in Congressional hearing
This one mainly goes out to our American friends who have had gagging orders placed on them by GlaxoSmithKline. I guess it's been hard on you all but.... read on.
A Congressional committee is looking for victims of defective products who settled, but had to keep the product details secret due to a secrecy clause in their settlement (i.e. Ford/Firestone, prescription drugs, medical device victims). Ideally, the defendant corporation settled previous cases in secrecy and did not resolve the product defect. Even if the victim cannot give specific details due to the settlement, it would still be helpful to have someone say, ‘I know about a dangerous product, but can’t tell you about it.’
If you know anyone who is willing to testify about their experience in a Congressional hearing, please contact Christine Zinner in the Public Affairs Department at (202)-944-2853 or christine.zinner@justice.org. Since the hearing is coming up very soon, we would appreciate any information as soon as possible.
A Congressional committee is looking for victims of defective products who settled, but had to keep the product details secret due to a secrecy clause in their settlement (i.e. Ford/Firestone, prescription drugs, medical device victims). Ideally, the defendant corporation settled previous cases in secrecy and did not resolve the product defect. Even if the victim cannot give specific details due to the settlement, it would still be helpful to have someone say, ‘I know about a dangerous product, but can’t tell you about it.’
If you know anyone who is willing to testify about their experience in a Congressional hearing, please contact Christine Zinner in the Public Affairs Department at (202)-944-2853 or christine.zinner@justice.org. Since the hearing is coming up very soon, we would appreciate any information as soon as possible.
Thursday, September 20, 2007
No posts for a while
Due to a recent heartbreak I won't be posting for a while.
I need some time alone and plenty of space to decide where my life is heading.
A future of uncertainty is not something I am particularly looking forward to
Be back soon
Fid
I need some time alone and plenty of space to decide where my life is heading.
A future of uncertainty is not something I am particularly looking forward to
Be back soon
Fid
Wednesday, September 19, 2007
Over 6,000 deaths - Zyprexa, rRsperdal, Clozaril and Paxil
Take a look at the stats from last week's adverse events report study in the archives of internal medicine. Over 1,000 deaths each caused by Zyprexa and Risperdal. more than 3,000 by Clozaril. 850 for Paxil. Somehow this completely missed the notice of the mainstream media. Excepting paxil, each of those drugs caused more deaths than vioxx, according to the study.
See more on Phil Dawdy's Furious Seasons
See more on Phil Dawdy's Furious Seasons
Tuesday, September 18, 2007
SmithKline Is Fined in a Reporting Failure
This article was sent to me by Dr Aubrey Blumsohn over at Scientific Misconduct
It shows clearly that GSK ... or then known as SmithKline have quite a habit of hiding data.
The article appeared in the New York Times in 27 February 1985.
The following is just a summary but it speaks volumes of the kind of people we are dealing with.
Federal District Judge Edward Cahn ordered SmithKline Beckman Corp topay $100,000 to a Child Abuse Program as a penalty for withholding word of dangerous side effects of a drug, Selacryn, designed to control blood pressure. Three physicians who were working for SmithKline in 1979 (when the data were withheld) were sentenced to five years' probation and ordered to perform 200 hours of public service in response to their pleas of no contest.
The firm had been charged with false labeling and with failing to file promptly evidence of the side effects. However, the judge is happy with his sentence because it is three times larger than what hecould have imposed as a fine ($34,000). The company does not argue with the
judgment.
Further research shows even more. I found this article from the NY TImes 1984
DRUG MAKER PLEADS GUILTY OVER LETHAL SIDE EFFECTS
Published: December 14, 1984
The SmithKline Bekman Corporation has pleaded guilty and two of its medical officials have pleaded no contest to charges of failing to report to the Food and Drug Administration the lethal side effects of the blood-pressure drug Selacryn.
In June the Philadelphia-based pharmaceutical giant and the three officers were charged with 14 counts of failing to file reports with the drug agency of adverse reactions to Selacryn and 20 counts of falsely labeling the drug with a statement that there was no known cause-and-effect relationship between Selacryn and liver damage.
Doctors across the country have reported 36 deaths and at least 500 severe cases of liver and kidney damage linked to Selacryn.
Two top officials of SmithKline's medical affairs department, Dr. Ralph M. Myerson of Merion, Pa., and Dr. Philip J. Tannenbaum of Broomall, and Dr. Theodore Selby of Haverford, a former official, pleaded no contest Wednesday in Federal District Court here to 14 counts of failing to file reports. The Government indicated it would drop charges against a fourth company official, Dr. Thomas G. Davis. Company's Guilty Plea
The company pleaded guilty to all 34 charges filed this summer.
Judge Edward Cahn, who heard the pleas at a two-hour hearing, set no date for sentencing.
J.Peter Smith, an assistant United States attorney, said part of the plea- bargain agreement was that the Government would make no recommendation on sentences.
Donald J. Goldberg, Dr. Selby's attorney, said the individual defendants would withdraw no-contest pleas and go to trial if Judge Cahn decided their sentences would include jail time.
SmithKline faces up to $34,000 in fines, and the individual doctors could receive up to 14 years in jail and $14,000 in fines. But Judge Cahn said community service could be part of whatever sentence he would impose.
The defendants were charged with failure to report to the drug agency within 15 days any unusual adverse effects of a drug.
Selacryn was developed 15 years ago by Anphar Laboratories, a subsidiary of Albert Rolland S. A., a French pharmaceutical company. In 1973, SmithKline obtained a license to develop and sell the drug in the United States.
Drug Won Quick Approval
The drug was introduced on May 2, 1979, after an unusually speedy review by the F.D.A. Typically the agency's approval of new drugs follows clinical tests on up to 1,500 patients. But in April 1979, after Selacryn had been tested on 533 patients, officials of the agency concluded that no further tests were required.
That same month, SmithKline and the three physician-defendants received reports from Anphar Laboratories that Selacryn had damaged patients' livers. The information was translated from French to English at SmithKline headquarters in Philadelphia in May 1979.
The information was never reported to the drug agency but ''dropped through the cracks,'' Mr. Goldberg told Judge Cahn Wednesday. ''There was a very human error here, and there was damage that resulted from it.''
The company and the drug agency removed Selacryn, which was sold from May 1979 to January 1980, from the market after the Federal agency learned of deaths among its users.
Jeremy Heymsfeld, a SmithKline spokesman in Philadelphia, said the company was now involved in 13 outstanding lawsuits involving the drug and had settled numerous other legal cases.
Dr. Sidney Wolfe, executive director of the Public Citizen Health Research Group, founded by Ralph Nader, said SmithKline had already paid $100,000 to $500,000 in out-of-court settlements in numerous cases.
Any High Court Judges reading this?
If a person has a history of murder he/she is locked up.
If a food company has a history of manufacturing food that makes people violently ill, they are closed down.
If a drugs giant have a history of hiding data thus causing death among patients - they are left to their own devices.
GlaxoSmithKline - Seroxat/Avandia - Which one of their high selling drugs is next? It could be one you or someone you know is taking.
Fid
For more information about the Selacryn cover up click HERE
It shows clearly that GSK ... or then known as SmithKline have quite a habit of hiding data.
The article appeared in the New York Times in 27 February 1985.
The following is just a summary but it speaks volumes of the kind of people we are dealing with.
Federal District Judge Edward Cahn ordered SmithKline Beckman Corp topay $100,000 to a Child Abuse Program as a penalty for withholding word of dangerous side effects of a drug, Selacryn, designed to control blood pressure. Three physicians who were working for SmithKline in 1979 (when the data were withheld) were sentenced to five years' probation and ordered to perform 200 hours of public service in response to their pleas of no contest.
The firm had been charged with false labeling and with failing to file promptly evidence of the side effects. However, the judge is happy with his sentence because it is three times larger than what hecould have imposed as a fine ($34,000). The company does not argue with the
judgment.
Further research shows even more. I found this article from the NY TImes 1984
DRUG MAKER PLEADS GUILTY OVER LETHAL SIDE EFFECTS
Published: December 14, 1984
The SmithKline Bekman Corporation has pleaded guilty and two of its medical officials have pleaded no contest to charges of failing to report to the Food and Drug Administration the lethal side effects of the blood-pressure drug Selacryn.
In June the Philadelphia-based pharmaceutical giant and the three officers were charged with 14 counts of failing to file reports with the drug agency of adverse reactions to Selacryn and 20 counts of falsely labeling the drug with a statement that there was no known cause-and-effect relationship between Selacryn and liver damage.
Doctors across the country have reported 36 deaths and at least 500 severe cases of liver and kidney damage linked to Selacryn.
Two top officials of SmithKline's medical affairs department, Dr. Ralph M. Myerson of Merion, Pa., and Dr. Philip J. Tannenbaum of Broomall, and Dr. Theodore Selby of Haverford, a former official, pleaded no contest Wednesday in Federal District Court here to 14 counts of failing to file reports. The Government indicated it would drop charges against a fourth company official, Dr. Thomas G. Davis. Company's Guilty Plea
The company pleaded guilty to all 34 charges filed this summer.
Judge Edward Cahn, who heard the pleas at a two-hour hearing, set no date for sentencing.
J.Peter Smith, an assistant United States attorney, said part of the plea- bargain agreement was that the Government would make no recommendation on sentences.
Donald J. Goldberg, Dr. Selby's attorney, said the individual defendants would withdraw no-contest pleas and go to trial if Judge Cahn decided their sentences would include jail time.
SmithKline faces up to $34,000 in fines, and the individual doctors could receive up to 14 years in jail and $14,000 in fines. But Judge Cahn said community service could be part of whatever sentence he would impose.
The defendants were charged with failure to report to the drug agency within 15 days any unusual adverse effects of a drug.
Selacryn was developed 15 years ago by Anphar Laboratories, a subsidiary of Albert Rolland S. A., a French pharmaceutical company. In 1973, SmithKline obtained a license to develop and sell the drug in the United States.
Drug Won Quick Approval
The drug was introduced on May 2, 1979, after an unusually speedy review by the F.D.A. Typically the agency's approval of new drugs follows clinical tests on up to 1,500 patients. But in April 1979, after Selacryn had been tested on 533 patients, officials of the agency concluded that no further tests were required.
That same month, SmithKline and the three physician-defendants received reports from Anphar Laboratories that Selacryn had damaged patients' livers. The information was translated from French to English at SmithKline headquarters in Philadelphia in May 1979.
The information was never reported to the drug agency but ''dropped through the cracks,'' Mr. Goldberg told Judge Cahn Wednesday. ''There was a very human error here, and there was damage that resulted from it.''
The company and the drug agency removed Selacryn, which was sold from May 1979 to January 1980, from the market after the Federal agency learned of deaths among its users.
Jeremy Heymsfeld, a SmithKline spokesman in Philadelphia, said the company was now involved in 13 outstanding lawsuits involving the drug and had settled numerous other legal cases.
Dr. Sidney Wolfe, executive director of the Public Citizen Health Research Group, founded by Ralph Nader, said SmithKline had already paid $100,000 to $500,000 in out-of-court settlements in numerous cases.
Any High Court Judges reading this?
If a person has a history of murder he/she is locked up.
If a food company has a history of manufacturing food that makes people violently ill, they are closed down.
If a drugs giant have a history of hiding data thus causing death among patients - they are left to their own devices.
GlaxoSmithKline - Seroxat/Avandia - Which one of their high selling drugs is next? It could be one you or someone you know is taking.
Fid
For more information about the Selacryn cover up click HERE
Monday, September 17, 2007
TGA & Delphi Centre - 'Commercial in Confidence'
Well, the Therapeutics Goods Administration did help remove the Aropax advertising from the Delphi Centre website (A Small Victory for Seroxat Sufferers)but it seems they don't want to do anything more about it.
I emailed them with the following:
I notice now that ALL advertisements have been removed. I thank you.
However, could you tell me if you will be investigating this matter further
as these adverts have been running on that very page since 2003?
Bob Fiddaman
Seroxat Sufferers
Their reply:
Dear Mr Fiddaman
The TGA have no objections to the Delphi Centre website as it currently stands.
Any information on the dealings between the TGA and Delphi Centre are considered to be 'commercial in confidence'. We now consider this matter closed.
Regards
Susan AnidoHead - Advertising Unit
Non Prescription Medicines Branch
Hmmm
I emailed them with the following:
I notice now that ALL advertisements have been removed. I thank you.
However, could you tell me if you will be investigating this matter further
as these adverts have been running on that very page since 2003?
Bob Fiddaman
Seroxat Sufferers
Their reply:
Dear Mr Fiddaman
The TGA have no objections to the Delphi Centre website as it currently stands.
Any information on the dealings between the TGA and Delphi Centre are considered to be 'commercial in confidence'. We now consider this matter closed.
Regards
Susan AnidoHead - Advertising Unit
Non Prescription Medicines Branch
Hmmm
Saturday, September 15, 2007
GRASSLEY SAYS E-MAILS SHOW GSK SILENCED AVANDIA CRITIC
Thanks to my good friend Stu who sent the following to me:
GRASSLEY SAYS E-MAILS SHOW GSK SILENCED AVANDIA CRITIC
FDA Week - Sep. 14, 2007
Sen. Charles Grassley (IA) said in a Senate floor speech Wednesday (Sept. 12) he has two internal e-mails from GlaxoSmithKline showing the company tried to silence a medical researcher who suggested Avandia may have health risks beyond those stated on the label.
John Buse, a medical researcher at the University of North Carolina, is the subject of the e-mails.
"Based on this e-mail exchange, it seems to me that at least two drug company officials did attempt to silence a critic," said Grassley, ranking Republican on the Finance Committee. "In fact, Dr. Buse stopped making any critical statements about Avandia shortly after this e-mail exchange," which is dated June 25, 1999.
One e-mail, titled "Avandia Renegade," says Buse has "repeatedly and intentionally misrepresented Avandia data."
"The sentiment of the [SmithKlineBeecham] group was to write him a firm letter that would warn him about doing this again...with the punishment that we will complain up his academic line and to the [continuing medical education] granting bodies that accredit his activities. There was a brief mention of a law suit but this was reserved for a later approach," the e-mail states.
SmithKlineBeecham is now part of GSK. The e-mail response states that Buse's supervisor would be spoken to.
"The question comes up as to whether you think this is a sensible strategy, whether you know any of the principals at UNC (I don't), and whether we have other avenues to ensure his accuracy in the future (we don't really do too much work at UNC to make any threats)?" the e-mail continues.
"I think that there are two courses of action. One is to sue him for knowingly defaming our product even after we have set him straight as to the facts--the other is to launch a well planned offensive on behalf of Avandia so that the listeners begin to understand at the very least that there are two sides to this story."
Buse testified in June at a House hearing that company employees threatened and harassed him after he raised concerns in 1999 that Avandia could increase the risk of heart attacks (see FDA Week, June 8). He also said company employees called higher-ups in his department to complain about him.
GSK at the time said Buse misinterpreted their actions.
"Action was taken at the time to correct any misconceptions that may have arisen," according to a GSK statement issued following Buse's testimony.
The Senate Finance Committee launched its investigation the day of the House hearing.
FDA recently announced the drug class that includes Avandia will soon bear stronger "black box warnings" that the drugs should not be prescribed to patients with a history of heart failure.
Also this week, the Journal of the American Medical Association published two studies questioning the safety of the diabetes drug.
GSK says the studies are flawed and Avandia is effective and safe when used appropriately.
Grassley also said on the floor the Avandia e-mails show how drug companies can influence continuing medical education course material.
Senate Finance Committee Chair Max Baucus (D-MT) and Grassley sent a letter in April to the organization that accredits CME stating that its retrospective, self-reported review of CME providers is not adequate to pick up industry influence (see FDA Week, Sept. 4).
Grassley and Sen. Herb Kohl (D-WI) last week introduced the Physicians Payments Sunshine Act. It requires drug and device companies to report payments and other gifts they give to doctors, which Grassley said would bring "a little transparency to the practice of companies such as GlaxoSmithKline."
GRASSLEY SAYS E-MAILS SHOW GSK SILENCED AVANDIA CRITIC
FDA Week - Sep. 14, 2007
Sen. Charles Grassley (IA) said in a Senate floor speech Wednesday (Sept. 12) he has two internal e-mails from GlaxoSmithKline showing the company tried to silence a medical researcher who suggested Avandia may have health risks beyond those stated on the label.
John Buse, a medical researcher at the University of North Carolina, is the subject of the e-mails.
"Based on this e-mail exchange, it seems to me that at least two drug company officials did attempt to silence a critic," said Grassley, ranking Republican on the Finance Committee. "In fact, Dr. Buse stopped making any critical statements about Avandia shortly after this e-mail exchange," which is dated June 25, 1999.
One e-mail, titled "Avandia Renegade," says Buse has "repeatedly and intentionally misrepresented Avandia data."
"The sentiment of the [SmithKlineBeecham] group was to write him a firm letter that would warn him about doing this again...with the punishment that we will complain up his academic line and to the [continuing medical education] granting bodies that accredit his activities. There was a brief mention of a law suit but this was reserved for a later approach," the e-mail states.
SmithKlineBeecham is now part of GSK. The e-mail response states that Buse's supervisor would be spoken to.
"The question comes up as to whether you think this is a sensible strategy, whether you know any of the principals at UNC (I don't), and whether we have other avenues to ensure his accuracy in the future (we don't really do too much work at UNC to make any threats)?" the e-mail continues.
"I think that there are two courses of action. One is to sue him for knowingly defaming our product even after we have set him straight as to the facts--the other is to launch a well planned offensive on behalf of Avandia so that the listeners begin to understand at the very least that there are two sides to this story."
Buse testified in June at a House hearing that company employees threatened and harassed him after he raised concerns in 1999 that Avandia could increase the risk of heart attacks (see FDA Week, June 8). He also said company employees called higher-ups in his department to complain about him.
GSK at the time said Buse misinterpreted their actions.
"Action was taken at the time to correct any misconceptions that may have arisen," according to a GSK statement issued following Buse's testimony.
The Senate Finance Committee launched its investigation the day of the House hearing.
FDA recently announced the drug class that includes Avandia will soon bear stronger "black box warnings" that the drugs should not be prescribed to patients with a history of heart failure.
Also this week, the Journal of the American Medical Association published two studies questioning the safety of the diabetes drug.
GSK says the studies are flawed and Avandia is effective and safe when used appropriately.
Grassley also said on the floor the Avandia e-mails show how drug companies can influence continuing medical education course material.
Senate Finance Committee Chair Max Baucus (D-MT) and Grassley sent a letter in April to the organization that accredits CME stating that its retrospective, self-reported review of CME providers is not adequate to pick up industry influence (see FDA Week, Sept. 4).
Grassley and Sen. Herb Kohl (D-WI) last week introduced the Physicians Payments Sunshine Act. It requires drug and device companies to report payments and other gifts they give to doctors, which Grassley said would bring "a little transparency to the practice of companies such as GlaxoSmithKline."
Friday, September 14, 2007
A Small Victory for Seroxat Sufferers
You may remember last week I reported about the Delphi Centre in Melbourne and their sponsorship page which carried the GSK logo and also the Aropax Logo - see HERE.
I wrote to the Therapeutics Goods Administration (TGA) who immediately wrote back to tell me the Aropax logo had been removed... it clearly had not - as Furious Seasons and many comments on here would prove.
Much to my delight the 'offending' logo has now been removed, for that I have to applaud the TGA.
Imagine if it was in this country and I had reported it to the MHRA!
It probably would have taken a five year investigation before the logo was removed.
So now, the Aropax logo isn't there - Sorry Glaxo, I just couldn't have you advertising your poison to our Australian friends.
Special thanks to all those who spread the word and also those who emailed the TGA
Fid
I wrote to the Therapeutics Goods Administration (TGA) who immediately wrote back to tell me the Aropax logo had been removed... it clearly had not - as Furious Seasons and many comments on here would prove.
Much to my delight the 'offending' logo has now been removed, for that I have to applaud the TGA.
Imagine if it was in this country and I had reported it to the MHRA!
It probably would have taken a five year investigation before the logo was removed.
So now, the Aropax logo isn't there - Sorry Glaxo, I just couldn't have you advertising your poison to our Australian friends.
Special thanks to all those who spread the word and also those who emailed the TGA
Fid
Thursday, September 13, 2007
GlaxoSmithKline caught... again!
Source: Bloomberg
GlaxoSmithKline Plc hid the risks of its Avandia diabetes drug to protect more than $2 billion in annual sales, according to a lawsuit filed by a lawyer who has won multimillion-dollar verdicts against other drugmakers.
FULL STORY
If GlaxoSmithKline were a group of people living in a house they would be facing the death penalty what with hiding Avandia data and the Paxil Study 329. But, no, they are still allowed to walk the streets and continue manufacturing poor drugs which always seem to slip by the MHRA!
Fid
GlaxoSmithKline Plc hid the risks of its Avandia diabetes drug to protect more than $2 billion in annual sales, according to a lawsuit filed by a lawyer who has won multimillion-dollar verdicts against other drugmakers.
FULL STORY
If GlaxoSmithKline were a group of people living in a house they would be facing the death penalty what with hiding Avandia data and the Paxil Study 329. But, no, they are still allowed to walk the streets and continue manufacturing poor drugs which always seem to slip by the MHRA!
Fid
Wednesday, September 12, 2007
Medicines Australia & The TGA Looking In
It seems rather than answer emails I sent to Medicines Australia and the Therapeutic Goods Administration (TGA), they would both rather look in at my blog!
12 September 07:59 Medicines Australia Incorporated, Napier, Western Australia, Australia
12 September 08:00 Cybertrust Australia Pty Ltd, Canberra, Australian Capital Territory, Australia
Shouldn't you be contacting The Delphi Centre, Melbourne and asking them to remove GlaxoSmithKline's blatent advertising of Aropax? Shouldn't you be both asking them why they allowed GlaxoSmithKline to advertise a prescribed drug when it is clear they are breaking an Australian law?
Therapeutic Goods Regulations (available at www.tga.gov.au) which apply to therapeutic goods, and aim to ensure their quality, safety and efficacy. We do not have any regulatory control over sponsorship arrangements by drug companies provided individual products are not promoted.
Seeing as neither of you will answer my emails - I hereby publically ask you - WHAT ARE YOU GOING TO DO ABOUT THE DELPHI CENTRE?
Fid
12 September 07:59 Medicines Australia Incorporated, Napier, Western Australia, Australia
12 September 08:00 Cybertrust Australia Pty Ltd, Canberra, Australian Capital Territory, Australia
Shouldn't you be contacting The Delphi Centre, Melbourne and asking them to remove GlaxoSmithKline's blatent advertising of Aropax? Shouldn't you be both asking them why they allowed GlaxoSmithKline to advertise a prescribed drug when it is clear they are breaking an Australian law?
Therapeutic Goods Regulations (available at www.tga.gov.au) which apply to therapeutic goods, and aim to ensure their quality, safety and efficacy. We do not have any regulatory control over sponsorship arrangements by drug companies provided individual products are not promoted.
Seeing as neither of you will answer my emails - I hereby publically ask you - WHAT ARE YOU GOING TO DO ABOUT THE DELPHI CENTRE?
Fid
Xenical/Alli - Can it cause heart attacks?
Earlier this year I posted about Alli, GlaxoSmithKline's new wonder diet pill. Much has been said about Glaxo's new baby but one comment after my post caused me great concern, so much so that I will republish it here.
I believe this product caused me to have a heart attack.I started having unusual symptoms, not the kind described with their product. I started having extreme sleeplessness. Couldn't go to sleep even at midnight and then wide awake at 5 AM. A nauseated stomach, a pain where I didn't want to eat much or it would make me sick. Then two days before the heart attack I started bleeding rectally with BM. Two days later, I had a short period of extreme dizziness, then sat down and had a heart attack.
I do not have a history of any heart problems or arrythmia's. And the follow-up echocardiogram and angiogram could see no abnormalities. And I have not had these problems since I stopped taking the product.
Anyone else out there having similar complaints?
katwilo2
I believe this product caused me to have a heart attack.I started having unusual symptoms, not the kind described with their product. I started having extreme sleeplessness. Couldn't go to sleep even at midnight and then wide awake at 5 AM. A nauseated stomach, a pain where I didn't want to eat much or it would make me sick. Then two days before the heart attack I started bleeding rectally with BM. Two days later, I had a short period of extreme dizziness, then sat down and had a heart attack.
I do not have a history of any heart problems or arrythmia's. And the follow-up echocardiogram and angiogram could see no abnormalities. And I have not had these problems since I stopped taking the product.
Anyone else out there having similar complaints?
katwilo2
Tuesday, September 11, 2007
Video for Australian & New Zealander Visitors to this Blog
I've had a lot of hits from down under this past week or so, probably down to the fact that Melbourne's Delphi Centre gets a mention on here for allowing GlaxoSmithKline to blatently advertise Aropax (Seroxat)
Most of the regular visitors on here will be familiar with Alistair Benbow of GSK UK.
Here's a chance for those down under to get aquainted with him.
Most of the regular visitors on here will be familiar with Alistair Benbow of GSK UK.
Here's a chance for those down under to get aquainted with him.
Reports of Adverse Drug Effects Up
Reports of Adverse Drug Effects Up
Increase Is ‘Cause for Alarm,’ Researchers Say
Source: Web MD
A similar story also runs in the Chicago Tribune
By Kathleen Doheny WebMD Medical News
Reviewed by Louise Chang, MD
Reports of adverse drug effects reported to the U.S. Food and Drug Administration (FDA) more than doubled in the last decade, according to a new study. Deaths associated with the serious effects also more than doubled.
"A change of this magnitude ought to be cause for alarm," says Thomas J. Moore, senior scientist, drug safety and policy, for the Institute for Safe Medication Practices in Huntingdon Valley, Pa., and the lead author of the study.
Moore and his colleagues analyzed serious adverse drug events voluntarily reported to the FDA though the Adverse Events Reporting System (AERS), known as the "MedWatch" reports, from 1998 to 2005. A serious adverse drug event is defined as one that results in death, a birth defect, disability, hospitalization, was life-threatening, or needed intervention to avoid harm.
The "hit list" of drugs often associated with adverse side effects includes the over-the-counter pain reliever acetaminophen (Tylenol) as well as insulin, the antidepressant paroxetine (Paxil), the anti-inflammatory drug celecoxib (Celebrex), and the painkiller fentanyl.
The report is published in the Sept. 10 issue of the Archives of Internal Medicine.
In all, 467,809 serious adverse events were reported during the years 1998 to 2005. But annually, the number of reports rose 2.6-fold from the years 1998 to 2005, Moore found.
In 1998, 34,966 adverse events were reported, but by 2005, the number had grown to 89,842.
Fatalities from adverse drug events rose from 5,519 in 1998 to 15,107, a 2.7-fold increase.
The Drug List
On the list of drugs most commonly identified in fatal events:
1. Oxycodone (OxyContin and others)
2. Fentanyl (Duragesic and others)
3. Clozapine (Clozaril)
4. Morphine
5. Acetaminophen (Tylenol)
6. Methadone
7. Infliximab (Remicade)
8. Interferon beta (Rebif, Betaseron, Avonex)
9. Risperidone (Risperdal)
10. Etanercept (Enbrel)
11. Paclitaxel (Taxol)
12. Acetaminophen-hydrocodone (Vicodin, Lortab, and others)
13. Olanzapine (Zyprexa)
14. Rofecoxib (Vioxx)*
15. Paroxetine (Paxil)
Drugs on the list of those most commonly identified in disability or serious outcomes:
1. Estrogens
2. Insulin
3. Infliximab (Remicade)
4. Interferon beta (Rebif, Betaseron, Avonex)
5. Paroxetine (Paxil)
6. Rofecoxib (Vioxx)*
7. Warfarin (Coumadin)
8. Atorvastatin (Lipitor)
9. Etanercept (Enbrel)
10. Celecoxib (Celebrex)
11. Phentermine (Pro-Fast)
12. Clozapine (Clozaril)
13. Interferon alfa (Alferon N, Infergen, Intron A, Roferon-A)
14. Simvastatin (Zocor)
15. Venlafaxine (Effexor)
* This drug is no longer available in the U.S.
What the Numbers Mean
"We are losing substantial amounts of ground in protecting people against serious injury and death from prescription drugs," Moore says. The rise in reports, he says, can't be explained by the fact that doctors are more willing to report adverse events under the voluntary reporting system.
Nor can the increase be explained totally by the rise in prescriptions, Moore says. The overall relative increase in adverse events was four times more than the growth of outpatient prescriptions, he says.
"About 25% of the change [in numbers of reports] is explained by more drug prescriptions to a growing, aging population." As expected, the number of adverse drug effects was higher in older people than younger ones. While people 65 and older account for 12.6% of the total U.S. population, they accounted for 33.6% of the reported adverse drug effects, Moore says.
Children under age 18 accounted for 7.4% of the serious adverse effects, he says, although they make up 25.8% of the population.
Biotechnology drugs, a whole new kind of drugs and products created by genetic engineering, is another reason for the increase, Moore tells WebMD. An example is Remicade, prescribed for rheumatoid arthritis and other problems, which is on the list of drugs that commonly cause adverse effects, including death.
"Painkillers have always been a problem, especially the opioids, but it seems to be getting worse," Moore says. "They are being used more." Fentanyl patches, for instance, made the list of common offenders, and Moore say they are "hugely powerful and very addictive."
Other Experts Weigh In
Increase Is ‘Cause for Alarm,’ Researchers Say
Source: Web MD
A similar story also runs in the Chicago Tribune
By Kathleen Doheny WebMD Medical News
Reviewed by Louise Chang, MD
Reports of adverse drug effects reported to the U.S. Food and Drug Administration (FDA) more than doubled in the last decade, according to a new study. Deaths associated with the serious effects also more than doubled.
"A change of this magnitude ought to be cause for alarm," says Thomas J. Moore, senior scientist, drug safety and policy, for the Institute for Safe Medication Practices in Huntingdon Valley, Pa., and the lead author of the study.
Moore and his colleagues analyzed serious adverse drug events voluntarily reported to the FDA though the Adverse Events Reporting System (AERS), known as the "MedWatch" reports, from 1998 to 2005. A serious adverse drug event is defined as one that results in death, a birth defect, disability, hospitalization, was life-threatening, or needed intervention to avoid harm.
The "hit list" of drugs often associated with adverse side effects includes the over-the-counter pain reliever acetaminophen (Tylenol) as well as insulin, the antidepressant paroxetine (Paxil), the anti-inflammatory drug celecoxib (Celebrex), and the painkiller fentanyl.
The report is published in the Sept. 10 issue of the Archives of Internal Medicine.
In all, 467,809 serious adverse events were reported during the years 1998 to 2005. But annually, the number of reports rose 2.6-fold from the years 1998 to 2005, Moore found.
In 1998, 34,966 adverse events were reported, but by 2005, the number had grown to 89,842.
Fatalities from adverse drug events rose from 5,519 in 1998 to 15,107, a 2.7-fold increase.
The Drug List
On the list of drugs most commonly identified in fatal events:
1. Oxycodone (OxyContin and others)
2. Fentanyl (Duragesic and others)
3. Clozapine (Clozaril)
4. Morphine
5. Acetaminophen (Tylenol)
6. Methadone
7. Infliximab (Remicade)
8. Interferon beta (Rebif, Betaseron, Avonex)
9. Risperidone (Risperdal)
10. Etanercept (Enbrel)
11. Paclitaxel (Taxol)
12. Acetaminophen-hydrocodone (Vicodin, Lortab, and others)
13. Olanzapine (Zyprexa)
14. Rofecoxib (Vioxx)*
15. Paroxetine (Paxil)
Drugs on the list of those most commonly identified in disability or serious outcomes:
1. Estrogens
2. Insulin
3. Infliximab (Remicade)
4. Interferon beta (Rebif, Betaseron, Avonex)
5. Paroxetine (Paxil)
6. Rofecoxib (Vioxx)*
7. Warfarin (Coumadin)
8. Atorvastatin (Lipitor)
9. Etanercept (Enbrel)
10. Celecoxib (Celebrex)
11. Phentermine (Pro-Fast)
12. Clozapine (Clozaril)
13. Interferon alfa (Alferon N, Infergen, Intron A, Roferon-A)
14. Simvastatin (Zocor)
15. Venlafaxine (Effexor)
* This drug is no longer available in the U.S.
What the Numbers Mean
"We are losing substantial amounts of ground in protecting people against serious injury and death from prescription drugs," Moore says. The rise in reports, he says, can't be explained by the fact that doctors are more willing to report adverse events under the voluntary reporting system.
Nor can the increase be explained totally by the rise in prescriptions, Moore says. The overall relative increase in adverse events was four times more than the growth of outpatient prescriptions, he says.
"About 25% of the change [in numbers of reports] is explained by more drug prescriptions to a growing, aging population." As expected, the number of adverse drug effects was higher in older people than younger ones. While people 65 and older account for 12.6% of the total U.S. population, they accounted for 33.6% of the reported adverse drug effects, Moore says.
Children under age 18 accounted for 7.4% of the serious adverse effects, he says, although they make up 25.8% of the population.
Biotechnology drugs, a whole new kind of drugs and products created by genetic engineering, is another reason for the increase, Moore tells WebMD. An example is Remicade, prescribed for rheumatoid arthritis and other problems, which is on the list of drugs that commonly cause adverse effects, including death.
"Painkillers have always been a problem, especially the opioids, but it seems to be getting worse," Moore says. "They are being used more." Fentanyl patches, for instance, made the list of common offenders, and Moore say they are "hugely powerful and very addictive."
Other Experts Weigh In
Monday, September 10, 2007
GSK Australia continue to dupe their public!
I actually thought it was well known now that the chemical imbalance theory was nothing more than a marketing ploy by Pharma to get their drug onto the shelves... not according to GlaxoSmithKline Australia who use the following on their Aropax product page:
Depression is longer lasting or more severe than the 'low moods' that everyone has from time to time. It is thought to be caused by a chemical imbalance in parts of the brain. This imbalance affects your whole body and can cause emotional and physical symptoms.
Aropax corrects the chemical imbalance and so helps relieve the symptoms of depression.
You have to really study the language used here, firstly ' It is thought to be caused...' - A clever cover-up by GlaxoSmithKline should things go tits up - you can imagine their defence in a courtroom can't you? 'We never claimed, we actually said it was thought'. However they shoot themselves in the foot by stating that their product, 'Aropax, corrects the chemical imbalance' - so from a chemical imbalance being merely a thought we now, later in their description, take it as given that there is a chemical imbalance!
Silly Glaxo
Question is... Why are they still claiming this on the Australian GlaxoSmithKline page?
The UK patient information leaflet (PIL) currently available for download here is even more ridiculous.
'People who are depressed or anxious have lower levels of serotonin than others.'
'It is not fully understood how Seroxat and other SSRIs work but they may help by increasing the level of serotonin in the brain.'
'May help' eh?
Not fully understood how it works? Roll up roll up ladies & gentlemen, I have with me the most amazing invention, there is no secret to how it works but you may or may not suffer with it, as a matter of fact I don't even know how it works but it will probably make you feel better by correcting something in your head that I don't even know exists! £5 anyone?
The creme de la creme on the UK patient information leaflet (PIL) is this wonderful advice from GSK... or is it the MHRA who sanction what is written on the PIL?
It reads:
If you get thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
So let me get this straight, if you are about to kill yourself you have probably been through the motions about who you will leave behind etc - the last thing that comes into the mind of someone who is suicidal is such a rational thought as 'Hey I should go see my doctor'
I'm not making light of suicide... it's actually the PIL that I am making light of.
Chemical Imbalance, my arse!
Fid
Depression is longer lasting or more severe than the 'low moods' that everyone has from time to time. It is thought to be caused by a chemical imbalance in parts of the brain. This imbalance affects your whole body and can cause emotional and physical symptoms.
Aropax corrects the chemical imbalance and so helps relieve the symptoms of depression.
You have to really study the language used here, firstly ' It is thought to be caused...' - A clever cover-up by GlaxoSmithKline should things go tits up - you can imagine their defence in a courtroom can't you? 'We never claimed, we actually said it was thought'. However they shoot themselves in the foot by stating that their product, 'Aropax, corrects the chemical imbalance' - so from a chemical imbalance being merely a thought we now, later in their description, take it as given that there is a chemical imbalance!
Silly Glaxo
Question is... Why are they still claiming this on the Australian GlaxoSmithKline page?
The UK patient information leaflet (PIL) currently available for download here is even more ridiculous.
'People who are depressed or anxious have lower levels of serotonin than others.'
'It is not fully understood how Seroxat and other SSRIs work but they may help by increasing the level of serotonin in the brain.'
'May help' eh?
Not fully understood how it works? Roll up roll up ladies & gentlemen, I have with me the most amazing invention, there is no secret to how it works but you may or may not suffer with it, as a matter of fact I don't even know how it works but it will probably make you feel better by correcting something in your head that I don't even know exists! £5 anyone?
The creme de la creme on the UK patient information leaflet (PIL) is this wonderful advice from GSK... or is it the MHRA who sanction what is written on the PIL?
It reads:
If you get thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
So let me get this straight, if you are about to kill yourself you have probably been through the motions about who you will leave behind etc - the last thing that comes into the mind of someone who is suicidal is such a rational thought as 'Hey I should go see my doctor'
I'm not making light of suicide... it's actually the PIL that I am making light of.
Chemical Imbalance, my arse!
Fid
Sunday, September 09, 2007
Some worthwhile links
Seroxat Secrets tackles the latest in Wikepedia and the deletion of many sources of reference from the anti-Seroxat brigade. It seems someone by the name of Paul Gene has deleted many entries, including: Lawsuits against GSK, the alleged gag placed on Rob Robinson, author of Paxil Protest, the UK litigation against GSK, Robbie Williams link with Seroxat. Something is obviously afoot, is Paul Gene a pseudonym or just another Marty Keller? You can read more over at Seroxat Secrets HERE & HERE
Phil Dawdy shows off his writing skills over at Furious Seasons. There's a great piece on The Times failure to recognise a major conflict of interest in a recent interview with Sanjay Gupta, a psychiatrist at the University of Buffalo. Phil writes that Gupta 'fibbed when he claimed there was no proof of a link between suicides and suicidality and anti-depressants, specifically Prozac. Not only was his claim incorrect, but as it now turns out Gupta has received honoraria and other funding from Eli Lilly in the past. This was not noted in his interview which recently ran in the New York Times.'
Phil also adds that Dr. Gupta is a consultant for Eli Lilly; has received research/grant support from Eli Lilly, Janssen, and Abbott; has received honoraria from Eli Lilly, Janssen, Forest, and Pfizer; and is on the speaker or advisory boards of Eli Lilly, Janssen, and Forest. Phil thanks CL Psych for the tip.
There's a much more poignant piece on Furious Seasons about a guy who shared the same name as Phil. I must admit it kind of brought home to me how valuable life is. I'm unsure how to link from Phil's site so you will just have to go to the homepage and read through his most recent articles. It's a thoroughly good read as are most of the level headed, non funded websites out there. Furious Seasons can be found HERE
Seroxat Sufferers regular Matthew Holford has been causing a stir within the MHRA it seems. I highlighted his email to Professors Breckenridge and Woods - there are many more emails to and from the MHRA on his blog 'It's Quite An Experience'
Fid
Phil Dawdy shows off his writing skills over at Furious Seasons. There's a great piece on The Times failure to recognise a major conflict of interest in a recent interview with Sanjay Gupta, a psychiatrist at the University of Buffalo. Phil writes that Gupta 'fibbed when he claimed there was no proof of a link between suicides and suicidality and anti-depressants, specifically Prozac. Not only was his claim incorrect, but as it now turns out Gupta has received honoraria and other funding from Eli Lilly in the past. This was not noted in his interview which recently ran in the New York Times.'
Phil also adds that Dr. Gupta is a consultant for Eli Lilly; has received research/grant support from Eli Lilly, Janssen, and Abbott; has received honoraria from Eli Lilly, Janssen, Forest, and Pfizer; and is on the speaker or advisory boards of Eli Lilly, Janssen, and Forest. Phil thanks CL Psych for the tip.
There's a much more poignant piece on Furious Seasons about a guy who shared the same name as Phil. I must admit it kind of brought home to me how valuable life is. I'm unsure how to link from Phil's site so you will just have to go to the homepage and read through his most recent articles. It's a thoroughly good read as are most of the level headed, non funded websites out there. Furious Seasons can be found HERE
Seroxat Sufferers regular Matthew Holford has been causing a stir within the MHRA it seems. I highlighted his email to Professors Breckenridge and Woods - there are many more emails to and from the MHRA on his blog 'It's Quite An Experience'
Fid
MHRA, TGA, FDA - On the same page?
Youi have to ask yourself whether or not these three agencies are actually on the same page when it comes to safeguarding the health of their relevant citizens.
I am adding a recent email Matthew Holford has recently sent to Professors Breckenridge and Woods at the MHRA.
My past experience with Woods and Breckenridge would suggest that Matthew's mail will not even be acknowledged by Breckenridge and if Woods replies it will be in the manner of a bombastic nature.
Anyway, here's his email to messrs Woods & Breckenridge:
Dear Professors Breckenridge and Woods,
My apologies, I should have copied you in on this, earlier. There appears to be a consensus amongst the (disinterested) scientific community that the withholding of data on drugs is unscientific. I would argue that it is unlawful, although I am interested to understand whether that view is shared by the Establishment.
Either way, the practice of suppressing negative data has contributed significantly to the Seroxat farce, in all its ignominy. To date, the MHRA has done nothing to ensure that that does not happen again. I would hold that that is incompetence of the highest order, and I can only imagine that it is not doing anything, because it is not in the interests of the Worshipful Company to do anything. That is corruption, if it be true. Are you corrupt, gentlemen?
Best regards
Matthew Holford
Well gentlemen, are you?
I am adding a recent email Matthew Holford has recently sent to Professors Breckenridge and Woods at the MHRA.
My past experience with Woods and Breckenridge would suggest that Matthew's mail will not even be acknowledged by Breckenridge and if Woods replies it will be in the manner of a bombastic nature.
Anyway, here's his email to messrs Woods & Breckenridge:
Dear Professors Breckenridge and Woods,
My apologies, I should have copied you in on this, earlier. There appears to be a consensus amongst the (disinterested) scientific community that the withholding of data on drugs is unscientific. I would argue that it is unlawful, although I am interested to understand whether that view is shared by the Establishment.
Either way, the practice of suppressing negative data has contributed significantly to the Seroxat farce, in all its ignominy. To date, the MHRA has done nothing to ensure that that does not happen again. I would hold that that is incompetence of the highest order, and I can only imagine that it is not doing anything, because it is not in the interests of the Worshipful Company to do anything. That is corruption, if it be true. Are you corrupt, gentlemen?
Best regards
Matthew Holford
Well gentlemen, are you?
Seroxat Safe for adults eh?
This from the Therapeutic Goods Administration webpage. 11 years ago folks!
About halfway down the page - http://www.tga.gov.au/docs/html/aadrbltn/aadr9602.htm#ssris
Australian Adverse Drug Reactions Bulletin
Volume 15, Number 1, February 1996
SSRIs and withdrawal syndrome
Withdrawal syndromes have long been recognised with the opioids and benzodiazepines but are rarely reported with other drugs. Fluoxetine (Prozac), paroxetine (Aropax) and sertraline (Zoloft) are antidepressant drugs belonging to the class of selective serotonin reuptake inhibitors (SSRI's). To date the Committee has received 26 reports of withdrawal symptoms in connection with the use of these drugs as summarised in the table below. (Table can be found by clicking on above link)
The age (range 23 to 68 years) and sex distribution (23 females and 9 males) probably reflect usage. In those reports which included the information, duration of therapy ranged from several weeks to months and onset of the reaction was within the first week (usually in the first couple of days) after ceasing therapy. In 8 cases the symptoms abated on recommencing the drug but recurred in 3 of these after the drug was again stopped. One patient experienced withdrawal symptoms in connection with sertraline and later, also with paroxetine.
The symptoms most commonly reported on withdrawal were dizziness (15 reports) and nausea (10). Anxiety, headache (both 5 reports), agitation, insomnia, increased sweating, tremor and vertigo (4 of each), hallucinations, and depersonalisation (3 of each) were also described. There was a total of 51 different symptoms documented in the reports with a wide range of other neurological and psychiatric symptoms including amnesia, ataxia, blurred vision, confusion, dysarthria, delirium, fatigue, hyperacusis*, hypertonia, meningism, mood swings, neurosis, nervousness, nightmares, paraesthesia, rigors, sensory disturbance, tinnitus, and twitching. There was also a report of a neonatal withdrawal reaction. Eighteen of the patients had recovered at the time of reporting and there were no fatalities.
Interestingly, paroxetine accounted for the majority of reports and its shorter elimination half-life in addition to the fact that it lacks active metabolites are possibly pertinent in this context. In contrast, fluoxetine has a longer half-life and its active metabolite, norfluoxetine has a half-life of 6-9 days.
Ed:
Hyperacusis*
Hyperacusis is a health condition characterized by an over-sensitivity to certain frequency ranges of sound (a collapsed tolerance to normal environmental sound). A person with hyperacusis has difficulty tolerating everyday sounds, some of which may seem unpleasantly loud to that person but not to others.
It can be acquired as a result of damage sustained to the hearing apparatus, or inner ear. There is speculation that the efferent portion of the auditory nerve {olivocochlear bundle} has been affected (efferent meaning fibers that originate in the brain which serve to regulate sounds). This theory also suggests that the efferent fibers of the auditory nerve are selectively damaged, while the hair cells that allow us to hear pure tones in an audiometric evaluation remain intact. In cases not involving aural trauma to the inner ear, hyperacusis can also be acquired as a result of damage to the brain or the neurological system. In these cases, hyperacusis can be defined as a cerebral processing problem specific to how the brain perceives sound. In rare cases, hyperacusis may be caused by a vestibular disorder. This type of hyperacusis, called vestibular hyperacusis, is caused by the brain perceiving certain sounds as motion input as well as auditory input.
To this day I still suffer with this... and I've been Seroxat free for over two years!
Fid
About halfway down the page - http://www.tga.gov.au/docs/html/aadrbltn/aadr9602.htm#ssris
Australian Adverse Drug Reactions Bulletin
Volume 15, Number 1, February 1996
SSRIs and withdrawal syndrome
Withdrawal syndromes have long been recognised with the opioids and benzodiazepines but are rarely reported with other drugs. Fluoxetine (Prozac), paroxetine (Aropax) and sertraline (Zoloft) are antidepressant drugs belonging to the class of selective serotonin reuptake inhibitors (SSRI's). To date the Committee has received 26 reports of withdrawal symptoms in connection with the use of these drugs as summarised in the table below. (Table can be found by clicking on above link)
The age (range 23 to 68 years) and sex distribution (23 females and 9 males) probably reflect usage. In those reports which included the information, duration of therapy ranged from several weeks to months and onset of the reaction was within the first week (usually in the first couple of days) after ceasing therapy. In 8 cases the symptoms abated on recommencing the drug but recurred in 3 of these after the drug was again stopped. One patient experienced withdrawal symptoms in connection with sertraline and later, also with paroxetine.
The symptoms most commonly reported on withdrawal were dizziness (15 reports) and nausea (10). Anxiety, headache (both 5 reports), agitation, insomnia, increased sweating, tremor and vertigo (4 of each), hallucinations, and depersonalisation (3 of each) were also described. There was a total of 51 different symptoms documented in the reports with a wide range of other neurological and psychiatric symptoms including amnesia, ataxia, blurred vision, confusion, dysarthria, delirium, fatigue, hyperacusis*, hypertonia, meningism, mood swings, neurosis, nervousness, nightmares, paraesthesia, rigors, sensory disturbance, tinnitus, and twitching. There was also a report of a neonatal withdrawal reaction. Eighteen of the patients had recovered at the time of reporting and there were no fatalities.
Interestingly, paroxetine accounted for the majority of reports and its shorter elimination half-life in addition to the fact that it lacks active metabolites are possibly pertinent in this context. In contrast, fluoxetine has a longer half-life and its active metabolite, norfluoxetine has a half-life of 6-9 days.
Ed:
Hyperacusis*
Hyperacusis is a health condition characterized by an over-sensitivity to certain frequency ranges of sound (a collapsed tolerance to normal environmental sound). A person with hyperacusis has difficulty tolerating everyday sounds, some of which may seem unpleasantly loud to that person but not to others.
It can be acquired as a result of damage sustained to the hearing apparatus, or inner ear. There is speculation that the efferent portion of the auditory nerve {olivocochlear bundle} has been affected (efferent meaning fibers that originate in the brain which serve to regulate sounds). This theory also suggests that the efferent fibers of the auditory nerve are selectively damaged, while the hair cells that allow us to hear pure tones in an audiometric evaluation remain intact. In cases not involving aural trauma to the inner ear, hyperacusis can also be acquired as a result of damage to the brain or the neurological system. In these cases, hyperacusis can be defined as a cerebral processing problem specific to how the brain perceives sound. In rare cases, hyperacusis may be caused by a vestibular disorder. This type of hyperacusis, called vestibular hyperacusis, is caused by the brain perceiving certain sounds as motion input as well as auditory input.
To this day I still suffer with this... and I've been Seroxat free for over two years!
Fid
The drugs don't work for GlaxoSmithKline
Source: The Business - London's first global business magazine
Jean-Pierre Garnier has no idea what his shares closed at last night but the chief executive of GlaxoSmithKline, Europe's largest drugs company, could be forgiven for not keeping up with what the market thinks.
GSK's shares have remained firmly stuck in the doldrums in recent months - in fact, they have gone south since the merger seven years ago of Glaxo Wellcome and SmithKline Beecham in 2000. Over that time, GSK's market value has dropped by a massive £54bn to £74bn.
In an interview with The Sunday Telegraph, Garnier admits the share price could be better but insists critics are wrong to focus on just that. "You need to be careful that you don't look at the tree - you've got to look at the forest," he says.
Garnier's argument is that over the longer term - since 1985 - the industry has created more value than any other. The year 2000 was "an abnormal peak" when share prices hit a high, he says, since when there has been a huge derating of the sector.
"The pharma industry has the potential to create enormous value for shareholders and has done so consistently until the recent past. That is not indicative of the future," he adds.
But it is the recent past that has been occupying Garnier's shareholders of late, many of whom bought into the story that bigger was better seven years ago. A number have even begun to wonder if there is not a more radical solution that could cure GSK's ills, such as spinning off the company's consumer business.
GSK insists no such radical surgery is necessary but has responded by hiking its dividend and increasing its share buyback. The move has been welcomed by investors but the company's share price and those of its peers remain sluggish. The dismal performances have led to some serious soul-searching within the industry and even prompted some to think the unthinkable: has Big Pharma become too big?
Unfortunately for Garnier, who is retiring at the company's annual meeting in May, it is difficult to think of a miracle cure that could allow him to depart on a high - at least when it comes to the share price.
Industry experts argue the traditional business model - where companies placed expensive bets on a few molecules and used their huge sales forces to market them to doctors in the hope they would turn into best sellers - is broken.
The Holy Grail of the industry is to develop new medicines. But despite billions of pounds put into research and development (R&D), most companies' laboratories are failing to come up with the goods. "Even allowing for inflation, the industry is investing twice as much in R&D as it was a decade ago to produce two-fifths of the new medicines it then produced," says a recent report from PricewaterhouseCoopers.
Last year, a record $55.2bn (£22.5bn) was spent on R&D in North America, but "the US Food and Drug Administration (FDA) approved only 22 new molecular entities (NMEs) and biologics (drugs from natural sources), a far cry from the 53 it approved in 1996," continues the report.
Moreover, only nine of the new treatments launched in the US last year came from the labs of the world's top 13 drugs companies.
More worrying, Big Pharma is relying for the bulk of its revenues - some 90 per cent - on medicines that have been on the market for more than five years. "Yet the patents on many of these products are due to expire quite shortly, exposing an estimated $157bn worth of sales (in 2005 terms) to generic erosion"," says the report.
Garnier is the first to admit that the average performance across the industry is not good enough.
"The opportunity to create significant value for our shareholders is right in front of us", he says. "The number-one mission of society is health. They want better health, people want to live forever and be fit and well".
The caveat, however, is productivity. "We have to be productive in terms of R&D, we have to come up with the drugs? If you crack this one, you will create enormous value for your shareholders."
GSK, he believes, is doing better than its rivals. The company is on the right path "to improve its fundamentals". But seven years after the merger is that really good enough? The question hits a nerve.
"When I took over as CEO I had two drugs in the late-stage pipeline. We have 33 today. Think about that," he hits back. "That is remarkable progress because the cycle of R&D is 15 years."
The company expects to launch 25 new products over the next five years, including at least two potential blockbusters, Cervarix, its cervical cancer vaccine, and Tykerb, a treatment for breast cancer.
One of the reasons GSK's pipeline is looking more healthy than that of many of its peers is because it has already changed the way its scientists work. As part of the merger in 2000, the company decided to split its research activities into a number of smaller units focused on different therapeutic areas. These so-called Cedds - Centres of Excellence for Drug Discovery - are run autonomously. The aim was to inject the entrepreneurial spirit of a biotechnology company into an organisation that employs more than 100,000 people in 117 countries.
The experiment has undoubtedly worked, but there is a difference between the number of medicines in a pipeline and the quality of these medicines; not all will be blockbusters.
"Why is our stock price not double what it is?" asks Garnier. "It has nothing to do with our pipeline, nobody has made the change in their structures in R&D that we have. The reason may be because some of the older drugs of GSK are being threatened by generics."
He knows what he is talking about. Since taking over at GSK, the company has lost three products - Paxil, for depression, the antibiotic Augmentin for infections and Wellbutrin, also for depression - with combined annual sales of £4bn to generic competition.
Garnier believes the market has misunderstood the extent of the company's exposure to generics. Advair, the company's best-selling asthma drug which generates sales of £3bn each year is due to come off patent in the US in 2010 and in Europe in 2013. Prescription medicines typically lose 90 per cent of their sales as soon as they come off patent, but Garnier argues that because Advair is an inhaled drug and not a pill, it is an exception. The delivery system is protected until 2018 so generics shouldn't have the automatic impact they would normally have.
"Nobody is unhappy about the derating of an industry," he says, "but we have improved our cost ratios every single year since the merger so this has been a very successful effort to strengthen the fundamentals of the company."
But even though GSK's laboratories appear to be delivering, there are many more that are not. Some long-term industry watchers argue that the poor stock prices across the sector are evidence that investors are unable to differentiate between those companies doing well and those that are not. The share prices of the top 12 companies are trading on a huge range of earnings multiples - between 11 and 22 times for 2008. This range narrows to just 9.5 to 11 times for 2010.
"That is telling you investors don't believe in the sustainability of the model any more," says one industry expert. Scenarios being mooted include companies reducing the time and costs involved in research by trying to gain a more holistic understanding of diseases early on. Others argue that companies need to change the way they market their products or even consider splitting off their sales activities from the research business. The trick is to provide more transparency for investors.
"There is so much subsumed within the pharma monolith," is how one analyst puts it.
Garnier believes the Big Pharma model still works "as long as you evolve it". "It is part of what we are doing and firmly part of what my successor will have to do. Some of the big pharma companies have not moved on their productivity problems and they will pay the price and some of them will not be around in the future," he says.
Would he back the merger that created GSK today? Yes, he says, adding that without a merger neither Glaxo nor SmithKline would have survived.
And given the challenges that are facing the industry, does a company such as GSK need a scientist or a marketer to lead it? Garnier is too circumspect to be drawn on this point but says: "They should be led by leaders with character and integrity."
Whoever ends up succeeding Garnier had better be ready to lead. Times will only get tougher.
Jean-Pierre Garnier has no idea what his shares closed at last night but the chief executive of GlaxoSmithKline, Europe's largest drugs company, could be forgiven for not keeping up with what the market thinks.
GSK's shares have remained firmly stuck in the doldrums in recent months - in fact, they have gone south since the merger seven years ago of Glaxo Wellcome and SmithKline Beecham in 2000. Over that time, GSK's market value has dropped by a massive £54bn to £74bn.
In an interview with The Sunday Telegraph, Garnier admits the share price could be better but insists critics are wrong to focus on just that. "You need to be careful that you don't look at the tree - you've got to look at the forest," he says.
Garnier's argument is that over the longer term - since 1985 - the industry has created more value than any other. The year 2000 was "an abnormal peak" when share prices hit a high, he says, since when there has been a huge derating of the sector.
"The pharma industry has the potential to create enormous value for shareholders and has done so consistently until the recent past. That is not indicative of the future," he adds.
But it is the recent past that has been occupying Garnier's shareholders of late, many of whom bought into the story that bigger was better seven years ago. A number have even begun to wonder if there is not a more radical solution that could cure GSK's ills, such as spinning off the company's consumer business.
GSK insists no such radical surgery is necessary but has responded by hiking its dividend and increasing its share buyback. The move has been welcomed by investors but the company's share price and those of its peers remain sluggish. The dismal performances have led to some serious soul-searching within the industry and even prompted some to think the unthinkable: has Big Pharma become too big?
Unfortunately for Garnier, who is retiring at the company's annual meeting in May, it is difficult to think of a miracle cure that could allow him to depart on a high - at least when it comes to the share price.
Industry experts argue the traditional business model - where companies placed expensive bets on a few molecules and used their huge sales forces to market them to doctors in the hope they would turn into best sellers - is broken.
The Holy Grail of the industry is to develop new medicines. But despite billions of pounds put into research and development (R&D), most companies' laboratories are failing to come up with the goods. "Even allowing for inflation, the industry is investing twice as much in R&D as it was a decade ago to produce two-fifths of the new medicines it then produced," says a recent report from PricewaterhouseCoopers.
Last year, a record $55.2bn (£22.5bn) was spent on R&D in North America, but "the US Food and Drug Administration (FDA) approved only 22 new molecular entities (NMEs) and biologics (drugs from natural sources), a far cry from the 53 it approved in 1996," continues the report.
Moreover, only nine of the new treatments launched in the US last year came from the labs of the world's top 13 drugs companies.
More worrying, Big Pharma is relying for the bulk of its revenues - some 90 per cent - on medicines that have been on the market for more than five years. "Yet the patents on many of these products are due to expire quite shortly, exposing an estimated $157bn worth of sales (in 2005 terms) to generic erosion"," says the report.
Garnier is the first to admit that the average performance across the industry is not good enough.
"The opportunity to create significant value for our shareholders is right in front of us", he says. "The number-one mission of society is health. They want better health, people want to live forever and be fit and well".
The caveat, however, is productivity. "We have to be productive in terms of R&D, we have to come up with the drugs? If you crack this one, you will create enormous value for your shareholders."
GSK, he believes, is doing better than its rivals. The company is on the right path "to improve its fundamentals". But seven years after the merger is that really good enough? The question hits a nerve.
"When I took over as CEO I had two drugs in the late-stage pipeline. We have 33 today. Think about that," he hits back. "That is remarkable progress because the cycle of R&D is 15 years."
The company expects to launch 25 new products over the next five years, including at least two potential blockbusters, Cervarix, its cervical cancer vaccine, and Tykerb, a treatment for breast cancer.
One of the reasons GSK's pipeline is looking more healthy than that of many of its peers is because it has already changed the way its scientists work. As part of the merger in 2000, the company decided to split its research activities into a number of smaller units focused on different therapeutic areas. These so-called Cedds - Centres of Excellence for Drug Discovery - are run autonomously. The aim was to inject the entrepreneurial spirit of a biotechnology company into an organisation that employs more than 100,000 people in 117 countries.
The experiment has undoubtedly worked, but there is a difference between the number of medicines in a pipeline and the quality of these medicines; not all will be blockbusters.
"Why is our stock price not double what it is?" asks Garnier. "It has nothing to do with our pipeline, nobody has made the change in their structures in R&D that we have. The reason may be because some of the older drugs of GSK are being threatened by generics."
He knows what he is talking about. Since taking over at GSK, the company has lost three products - Paxil, for depression, the antibiotic Augmentin for infections and Wellbutrin, also for depression - with combined annual sales of £4bn to generic competition.
Garnier believes the market has misunderstood the extent of the company's exposure to generics. Advair, the company's best-selling asthma drug which generates sales of £3bn each year is due to come off patent in the US in 2010 and in Europe in 2013. Prescription medicines typically lose 90 per cent of their sales as soon as they come off patent, but Garnier argues that because Advair is an inhaled drug and not a pill, it is an exception. The delivery system is protected until 2018 so generics shouldn't have the automatic impact they would normally have.
"Nobody is unhappy about the derating of an industry," he says, "but we have improved our cost ratios every single year since the merger so this has been a very successful effort to strengthen the fundamentals of the company."
But even though GSK's laboratories appear to be delivering, there are many more that are not. Some long-term industry watchers argue that the poor stock prices across the sector are evidence that investors are unable to differentiate between those companies doing well and those that are not. The share prices of the top 12 companies are trading on a huge range of earnings multiples - between 11 and 22 times for 2008. This range narrows to just 9.5 to 11 times for 2010.
"That is telling you investors don't believe in the sustainability of the model any more," says one industry expert. Scenarios being mooted include companies reducing the time and costs involved in research by trying to gain a more holistic understanding of diseases early on. Others argue that companies need to change the way they market their products or even consider splitting off their sales activities from the research business. The trick is to provide more transparency for investors.
"There is so much subsumed within the pharma monolith," is how one analyst puts it.
Garnier believes the Big Pharma model still works "as long as you evolve it". "It is part of what we are doing and firmly part of what my successor will have to do. Some of the big pharma companies have not moved on their productivity problems and they will pay the price and some of them will not be around in the future," he says.
Would he back the merger that created GSK today? Yes, he says, adding that without a merger neither Glaxo nor SmithKline would have survived.
And given the challenges that are facing the industry, does a company such as GSK need a scientist or a marketer to lead it? Garnier is too circumspect to be drawn on this point but says: "They should be led by leaders with character and integrity."
Whoever ends up succeeding Garnier had better be ready to lead. Times will only get tougher.
Friday, September 07, 2007
Work for GSK India
Ever fancied yourself as a hot shot rep?
GSK have a vacancy in India - why not apply?
It should be a breeze seeing as Seroxat is called Paradise CR over there.
Let's define the word Paradise
1 a : EDEN 2 b : an intermediate place or state where the souls of the righteous await resurrection and the final judgment c : HEAVEN
2 : a place or state of bliss, felicity, or delight
Hardly seems appropriate for Seroxat does it?
Anyway back to the application which can be viewed HERE
I just love the opening paragraph:
Every second 35 people around the world are given a GlaxoSmithKline vaccines; every minute, 1,100 people receive a prescription for one of our products; every hour, GlaxoSmithKline globally spends half a million dollars on research and development.
In India, we are the country's largest pharmaceutical company. We market a wide range of ethical formulations & are the leaders in several therapeutic areas.
Then there is the job 'responsibilities'
Responsibilities:
Meeting daily minimum 11 Doctors & 6 retailers, detailing about gsk Medicines and generating targetted Sales.
There are of course requirements but no mention of how one must lie through their back teeth about withdrawal.
So, you fancy your chances as a GSK Medical Representitive?
Those without a conscience need not apply.
http://myjobstreet.jobstreet.com/_oa/online_apply.asp
A job made in Paradise
Fid
GSK have a vacancy in India - why not apply?
It should be a breeze seeing as Seroxat is called Paradise CR over there.
Let's define the word Paradise
1 a : EDEN 2 b : an intermediate place or state where the souls of the righteous await resurrection and the final judgment c : HEAVEN
2 : a place or state of bliss, felicity, or delight
Hardly seems appropriate for Seroxat does it?
Anyway back to the application which can be viewed HERE
I just love the opening paragraph:
Every second 35 people around the world are given a GlaxoSmithKline vaccines; every minute, 1,100 people receive a prescription for one of our products; every hour, GlaxoSmithKline globally spends half a million dollars on research and development.
In India, we are the country's largest pharmaceutical company. We market a wide range of ethical formulations & are the leaders in several therapeutic areas.
Then there is the job 'responsibilities'
Responsibilities:
Meeting daily minimum 11 Doctors & 6 retailers, detailing about gsk Medicines and generating targetted Sales.
There are of course requirements but no mention of how one must lie through their back teeth about withdrawal.
So, you fancy your chances as a GSK Medical Representitive?
Those without a conscience need not apply.
http://myjobstreet.jobstreet.com/_oa/online_apply.asp
A job made in Paradise
Fid
How Does It Feel GSK?
Paxil/Seroxat/Aropax videos popping up all over youtube lately. People have just had enough!
Here's a hard hitting one from Julie, the mother of Manie, a Seroxat victim without being given a choice or say in the matter. Julies Blog can be found here
Julie Edgington started taking Paxil one month before she became pregnant and stopped taking it by the end of the third month of pregnancy.
"I asked the doctor about Paxil and he said 'Paxil shouldn't be a problem," Edgington says, but she decided to stop taking it after three months. Unfortunately, her unborn baby had already been exposed to Paxil and even three months was long enough for the drug to have a serious effect on him.
The pregnancy itself was problem-free. "I had no idea there were any complications," Edgington says. Right up until Edgington went into labor the pregnancy seemed fine. However, once Manie was delivered, his problems began right away.
"He started turning blue," Edgington says. "The doctor said he was blue as a smurf." The more Manie cried the more blue he turned and the doctor had no idea what was wrong with him. A specialist was called in but even he did not know what was wrong. So Manie was airlifted to a different hospital.
At the new hospital doctors performed a procedure--known as a balloon atrial septostomy--in which a hole was created in Manie's heart to keep him alive. This kept him alive until he was able to have open-heart surgery for an atrial switch performed when he was eight days old. Manie had been born with transposition of the great arteries.
In addition to his heart problems, Manie developed acid reflux, which caused extensive damage to his throat and teeth. For a few months, Manie was required to take an adult dose of Prevacid to combat his acid reflux.
At only three years old, Manie has endured medical procedures that most people probably could not imagine undergoing. He has had open-heart surgery, balloon atrial septostomy, four cardiac catheterizations, and numerous scopes performed. During one of the catheterizations, doctors discovered collaterals growing off of his heart which caused his hart and lungs to work extra hard. Coils were put in to treat the collaterals, but more coils will be needed.
Additionally, Manie will require further medical procedures as he grows. Those include surgery to fix a leaky valve that resulted from his first open heart surgery and another open heart surgery when he is fully-grown.
For right now, Manie is on medication for his high blood pressure, a side effect of the leaky valve in his heart. Edgington says he keeps up with other children with little difficulty, except that he tires easily.
Edgington wants the makers of Paxil to be held accountable for their actions. "This is affecting newborns," Edgington says. "Where's it going to stop? How can they do this to newborns?"
She wants people to know that Manie is a person, not a statistic. "He's gone through more than most people can imagine," Edgington says.
Edgington says that her fight against Paxil is like a mission. "I want to keep this from happening to others," she says. "They keep saying that the risk is small, but the benefits do not outweigh the risks. I just want to tell women not to take Paxil when they're pregnant."
Public Health Advisory
The FDA issued a Public Health Advisory for Paxil on December 8, 2005 based on U.S. and Swedish studies showing that exposure to Paxil in the first trimester of pregnancy may be associated with an increased risk of heart birth defects. Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed. In general, septal defects are among the most common congenital malformations.
Source: Lawyersandsettlements.com
Here's a hard hitting one from Julie, the mother of Manie, a Seroxat victim without being given a choice or say in the matter. Julies Blog can be found here
Julie Edgington started taking Paxil one month before she became pregnant and stopped taking it by the end of the third month of pregnancy.
"I asked the doctor about Paxil and he said 'Paxil shouldn't be a problem," Edgington says, but she decided to stop taking it after three months. Unfortunately, her unborn baby had already been exposed to Paxil and even three months was long enough for the drug to have a serious effect on him.
The pregnancy itself was problem-free. "I had no idea there were any complications," Edgington says. Right up until Edgington went into labor the pregnancy seemed fine. However, once Manie was delivered, his problems began right away.
"He started turning blue," Edgington says. "The doctor said he was blue as a smurf." The more Manie cried the more blue he turned and the doctor had no idea what was wrong with him. A specialist was called in but even he did not know what was wrong. So Manie was airlifted to a different hospital.
At the new hospital doctors performed a procedure--known as a balloon atrial septostomy--in which a hole was created in Manie's heart to keep him alive. This kept him alive until he was able to have open-heart surgery for an atrial switch performed when he was eight days old. Manie had been born with transposition of the great arteries.
In addition to his heart problems, Manie developed acid reflux, which caused extensive damage to his throat and teeth. For a few months, Manie was required to take an adult dose of Prevacid to combat his acid reflux.
At only three years old, Manie has endured medical procedures that most people probably could not imagine undergoing. He has had open-heart surgery, balloon atrial septostomy, four cardiac catheterizations, and numerous scopes performed. During one of the catheterizations, doctors discovered collaterals growing off of his heart which caused his hart and lungs to work extra hard. Coils were put in to treat the collaterals, but more coils will be needed.
Additionally, Manie will require further medical procedures as he grows. Those include surgery to fix a leaky valve that resulted from his first open heart surgery and another open heart surgery when he is fully-grown.
For right now, Manie is on medication for his high blood pressure, a side effect of the leaky valve in his heart. Edgington says he keeps up with other children with little difficulty, except that he tires easily.
Edgington wants the makers of Paxil to be held accountable for their actions. "This is affecting newborns," Edgington says. "Where's it going to stop? How can they do this to newborns?"
She wants people to know that Manie is a person, not a statistic. "He's gone through more than most people can imagine," Edgington says.
Edgington says that her fight against Paxil is like a mission. "I want to keep this from happening to others," she says. "They keep saying that the risk is small, but the benefits do not outweigh the risks. I just want to tell women not to take Paxil when they're pregnant."
Public Health Advisory
The FDA issued a Public Health Advisory for Paxil on December 8, 2005 based on U.S. and Swedish studies showing that exposure to Paxil in the first trimester of pregnancy may be associated with an increased risk of heart birth defects. Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed. In general, septal defects are among the most common congenital malformations.
Source: Lawyersandsettlements.com
Thursday, September 06, 2007
Youth Suicides Increased As Antidepressant Use Fell
Quite a startling headling from the Washington Post.
Maybe we've all been wrong and anti-depressants are really a great source of help.
The full story can be read here
Once you have read the story you might want to learn that Thomas Insel, director of the National Institute of Mental Health, who is quoted in the article as saying "We may have inadvertently created a problem by putting a 'black box' warning on medications that were useful." He added, "If the drugs were doing more harm than good, then the reduction in prescription rates should mean the risk of suicide should go way down, and it hasn't gone down at all -- it has gone up," may have more than one or two shared interests to be so one track minded.
Lets see who the National Institute of Mental Health's Corporate Partners are shall we:
Abbott Laboratories
Alamo Pharmaceuticals
AstraZeneca Pharmaceuticals
BIO
Bristol-Myers Squibb Company
Cyberonics, Inc.
Eli Lilly and Company
Forest Laboratories
GlaxoSmithKline
Janssen Pharmaceutica
Magellan Health Services
Neuronetics
Otsuka America Pharmaceutical, Inc.
PhRMA
Pfizer, Inc.
Solvay Pharmaceuticals
WellPoint Health Networks
Wyeth Pharmaceuticals
Now correct me If I am wrong but don't these pharmaceutical companies manufacture anti-depressants?
Over to you Mr Insel
Fid
Maybe we've all been wrong and anti-depressants are really a great source of help.
The full story can be read here
Once you have read the story you might want to learn that Thomas Insel, director of the National Institute of Mental Health, who is quoted in the article as saying "We may have inadvertently created a problem by putting a 'black box' warning on medications that were useful." He added, "If the drugs were doing more harm than good, then the reduction in prescription rates should mean the risk of suicide should go way down, and it hasn't gone down at all -- it has gone up," may have more than one or two shared interests to be so one track minded.
Lets see who the National Institute of Mental Health's Corporate Partners are shall we:
Abbott Laboratories
Alamo Pharmaceuticals
AstraZeneca Pharmaceuticals
BIO
Bristol-Myers Squibb Company
Cyberonics, Inc.
Eli Lilly and Company
Forest Laboratories
GlaxoSmithKline
Janssen Pharmaceutica
Magellan Health Services
Neuronetics
Otsuka America Pharmaceutical, Inc.
PhRMA
Pfizer, Inc.
Solvay Pharmaceuticals
WellPoint Health Networks
Wyeth Pharmaceuticals
Now correct me If I am wrong but don't these pharmaceutical companies manufacture anti-depressants?
Over to you Mr Insel
Fid
MHRA Correspondence
Seroxat Sufferers regular, Matthew Holford, is the preverbal thorn in the side of the MHRA over on his new blog 'It's Quite An Experience'. With correspondence between himself and the various puppets at the MHRA it makes very interesting reading indeed.
Some of their replies are laughable to say the least... this from an agency who boast transparency.
Way to go Matt.
Some of their replies are laughable to say the least... this from an agency who boast transparency.
Way to go Matt.
Still no reply from...
...The Therapeutic Goods Administration in Australia regarding the Delphi Centre and their close relationship with GlaxoSmithKline... so close that they allow GSK to advertise Aropax on their sponsorship page
This blog was hit by a lot of IP's from Australia and New Zealand yesterday, I hope it is the general public and not those from the TGA and Delphi flapping around wondering what the hell they should do to cover up their embarrassment. God help me I just wouldn't be able to sleep at night if I hurt them.
TGA, Delphi - I await your replies. C'mon, simple enough
Fid
This blog was hit by a lot of IP's from Australia and New Zealand yesterday, I hope it is the general public and not those from the TGA and Delphi flapping around wondering what the hell they should do to cover up their embarrassment. God help me I just wouldn't be able to sleep at night if I hurt them.
TGA, Delphi - I await your replies. C'mon, simple enough
Fid
Wednesday, September 05, 2007
Seroxat and Mathematics
A person on 40mg of Seroxat for 6 years will intake 87,600mgs. That's 3.08 ounces.
Now say this person had tried to stop taking Seroxat three years in.
GlaxoSmithKline and the MHRA have a lot to answer for don't they?
Now say this person had tried to stop taking Seroxat three years in.
GlaxoSmithKline and the MHRA have a lot to answer for don't they?
Delphi Centre, GSK and the TGA
This is so bizzare. You may recall one of my earlier posts regarding The Delphi Centre in Melbourne, Australia - they were allowing GlaxoSmithKline (and others) to blatantly advertise Aropax on their webpage. See HERE & HERE
I wrote to the Therapeutic Goods Administration (TGA) - I think they are the equivalent of the MHRA and the FDA.
Now either the TGA are lying to me or are about as useful as a chocolate kettle!
Here is the email I received and underneath my subsequent response.
----- Original Message -----
From: TGA.Advertising@tga.gov.au
To: fiddaman
Sent: Wednesday, September 05, 2007 1:01 AM
Subject: Fw: Disgraceful behaviour [SEC=UNCLASSIFIED]
Dear Mr Fiddaman,
Thank you for your email of 4 September 2007. Upon review of the Delphi Centre homepage today, all advertisements for the product "Aropax" appear to have been removed.
For your information, the Therapeutic Goods Administration (TGA) administers the Commonwealth Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations (available at www.tga.gov.au) which apply to therapeutic goods, and aim to ensure their quality, safety and efficacy. We do not have any regulatory control over sponsorship arrangements by drug companies provided individual products are not promoted. Thank you again for bringing this matter to the attention of the TGA.
Regards
Susan Anido Advertising Unit
Therapeutic Goods Administration
and my response...
----- Original Message -----
From: "fiddaman" fiddaman
To: TGA.Advertising@tga.gov.au
Sent: Wednesday, September 05, 2007 3:09 AM
Subject: Re: Disgraceful behaviour [SEC=UNCLASSIFIED]
Are you lying to me or do you just have incompotent staff?
It's just gone 3am here in the UK and a quick glimpse of the webpage shows that GSK are still blatantly advertising Aropax here -http://www.delphicentre.com.au/conference/sponsors.htm
I've taken 3 snapshots of the webpage too - see attached. What are you going to do about this?
Sincerely
Mr Robert Fiddaman
It is clear that both GlaxoSmithKline and the Delphi Centre are breaking the Australian Advertising law '
Therapeutic Goods Regulations (available at www.tga.gov.au) which apply to therapeutic goods, and aim to ensure their quality, safety and efficacy. We do not have any regulatory control over sponsorship arrangements by drug companies provided individual products are not promoted.
What on earth is going on here?
I wrote to the Therapeutic Goods Administration (TGA) - I think they are the equivalent of the MHRA and the FDA.
Now either the TGA are lying to me or are about as useful as a chocolate kettle!
Here is the email I received and underneath my subsequent response.
----- Original Message -----
From: TGA.Advertising@tga.gov.au
To: fiddaman
Sent: Wednesday, September 05, 2007 1:01 AM
Subject: Fw: Disgraceful behaviour [SEC=UNCLASSIFIED]
Dear Mr Fiddaman,
Thank you for your email of 4 September 2007. Upon review of the Delphi Centre homepage today, all advertisements for the product "Aropax" appear to have been removed.
For your information, the Therapeutic Goods Administration (TGA) administers the Commonwealth Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations (available at www.tga.gov.au) which apply to therapeutic goods, and aim to ensure their quality, safety and efficacy. We do not have any regulatory control over sponsorship arrangements by drug companies provided individual products are not promoted. Thank you again for bringing this matter to the attention of the TGA.
Regards
Susan Anido Advertising Unit
Therapeutic Goods Administration
and my response...
----- Original Message -----
From: "fiddaman" fiddaman
To: TGA.Advertising@tga.gov.au
Sent: Wednesday, September 05, 2007 3:09 AM
Subject: Re: Disgraceful behaviour [SEC=UNCLASSIFIED]
Are you lying to me or do you just have incompotent staff?
It's just gone 3am here in the UK and a quick glimpse of the webpage shows that GSK are still blatantly advertising Aropax here -http://www.delphicentre.com.au/conference/sponsors.htm
I've taken 3 snapshots of the webpage too - see attached. What are you going to do about this?
Sincerely
Mr Robert Fiddaman
It is clear that both GlaxoSmithKline and the Delphi Centre are breaking the Australian Advertising law '
Therapeutic Goods Regulations (available at www.tga.gov.au) which apply to therapeutic goods, and aim to ensure their quality, safety and efficacy. We do not have any regulatory control over sponsorship arrangements by drug companies provided individual products are not promoted.
What on earth is going on here?
Monday, September 03, 2007
Taken On Trust - New Zealand News Video
You can view the programme aired on 30 August 2007 in New Zealand
'Click here to watch the Taken on Trust video '
Hope the Delphi Centre are looking in AND GSK!
Fid
'Click here to watch the Taken on Trust video '
Hope the Delphi Centre are looking in AND GSK!
Fid
The Delphi Centre Melbourne...
How can the Delphi Centre allow blatant advertising from Pharmaceutical Companies on their web page.
Surely this is against Australian law?
Click on pics to see each segment of the page I'm referring to.
Pic one is top of Delphi Page
Pic two, middle
Pic three, bottom
Surely this is against Australian law?
Click on pics to see each segment of the page I'm referring to.
Pic one is top of Delphi Page
Pic two, middle
Pic three, bottom
More on the Delphi centre HERE and HERE
They still haven't answered the email I sent them!
An email has been sent to the Therapeutic Goods Administration
Hey GSK, Ickenham, Slough...
... SHOULDN'T YOU BE WORKING INSTEAD OF READING THIS BLOG?
3 September 08:51 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 08:59 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 09:00 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 09:07 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 09:26 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 10:53 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 11:20 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 15:43 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 15:44 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 15:46 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 16:58 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 17:03 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 17:05 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 17:11 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 17:16 GlaxoSmithKline, Ickenham, Slough, United Kingdom
An employee with a crisis of conscience?
Benbow getting off on his quotes again?
Team briefing showing staff how to improve their image?
Ain't you supposed to be making tablets or hiding information?
Hope you like what you read.
I just love the webstats tracking device don't you?
Fid
3 September 08:51 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 08:59 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 09:00 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 09:07 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 09:26 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 10:53 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 11:20 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 15:43 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 15:44 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 15:46 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 16:58 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 17:03 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 17:05 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 17:11 GlaxoSmithKline, Ickenham, Slough, United Kingdom
3 September 17:16 GlaxoSmithKline, Ickenham, Slough, United Kingdom
An employee with a crisis of conscience?
Benbow getting off on his quotes again?
Team briefing showing staff how to improve their image?
Ain't you supposed to be making tablets or hiding information?
Hope you like what you read.
I just love the webstats tracking device don't you?
Fid
New subsidised anti-depressant for New Zealand
Source: tvnz.co.nz
The nearly 50,000 New Zealanders taking the anti-depressant Aropax will soon be offered a new subsidised drug to replace it.
Funding for Aropax is being phased out in favour of the clinically identical Loxamine, which will be available from April.
Pharmac says because Loxamine is being sold at a lower price by its makers, it will free-up an extra $45 million to spend on other drugs.
Nothing to do with the fact that Aropax causes severe side effects during withdrawal or the fact that there are and have been numerous class action lawsuits against GlaxoSmithKline regarding this particular drug?
The nearly 50,000 New Zealanders taking the anti-depressant Aropax will soon be offered a new subsidised drug to replace it.
Funding for Aropax is being phased out in favour of the clinically identical Loxamine, which will be available from April.
Pharmac says because Loxamine is being sold at a lower price by its makers, it will free-up an extra $45 million to spend on other drugs.
Nothing to do with the fact that Aropax causes severe side effects during withdrawal or the fact that there are and have been numerous class action lawsuits against GlaxoSmithKline regarding this particular drug?
Sunday, September 02, 2007
Investors call for surgical strike on GSK
Source: The Guardian Unlimited
Shareholders want new boss to streamline firm
Richard Wachman, city editor
Sunday September 2, 2007
The Observer
GlaxoSmithKline, the UK drugs giant, faces a shareholder revolt over its dismal share price performance. Anger has spilt into discussions between investors and chairman Sir Christopher Gent over who should succeed chief executive Jean-Pierre Garnier. He is due to retire in May 2008.
GSK's big institutional shareholders have held meetings with Gent and told him in no uncertain terms that Garnier's successor should be someone who is prepared to undertake a fundamental overhaul of the company and consider a radical streamlining of its operations, including a possible break-up.
The company, formed out of a merger between Glaxo and SmithKline in 2000, has been swept up in a tide of shareholder discontent with questions being asked about whether the giant pharmaceutical companies - Big Pharma - operate effectively and efficiently.
An analyst said: 'GSK is facing a backlash from investors who want the company to consider whether large, and sometimes cumbersome operations, such as GSK, are best placed to come up with new medicines.'
Shareholders want Garnier's successor to look at all options. These include: demerging manufacturing and/or the research and development arms, shrinking the firm's massive sales force, and offloading non-core operations such as the drinks subsidiary which owns brands including Ribena and Lucozade.
One institutional investor says: 'What we are telling the chairman is that with the industry facing a regulatory clampdown that makes it more difficult to get new medicines approved, GSK should look at ways to release shareholder value. The status quo is no longer an option.'
Another shareholder, who spoke on the basis of anonymity, says: 'GSK should recognise that Big Pharma is broken and needs to be fixed. Garnier's successor needs to take that on board. It's no good producing more of the same.'
Four potential candidates are jostling for the top job: David Stout, president of pharmaceutical operations; Chris Viehbacher, head of the US side, who is thought to be the frontrunner; Andrew Witty, the British head of European operations; and Russell Greig, head of the international division.
GSK's shares traded at close to £15 in early 2000 against a Friday close of £12.79. The stock price has been hit by safety fears linked to Avandia, one of its leading drugs, worries about generic competition and concern about a possible dearth of new blockbuster medicines in GSK's R&D pipeline.
Neil Ransome, head of the pharmaceuticals department at PricewaterhouseCoopers' corporate finance arm, said recently: 'Evidence that mega-mergers in this sector improve the rate of discovery of new drugs isn't compelling.'
Experts say the industry could move towards a model where companies farm out R&D to small biotech companies.
Analysts Citigroup shook the market earlier this year with research suggesting breaking up GSK could boost the value of the firm by half and enable the company to return £20bn to shareholders.
Shareholders want new boss to streamline firm
Richard Wachman, city editor
Sunday September 2, 2007
The Observer
GlaxoSmithKline, the UK drugs giant, faces a shareholder revolt over its dismal share price performance. Anger has spilt into discussions between investors and chairman Sir Christopher Gent over who should succeed chief executive Jean-Pierre Garnier. He is due to retire in May 2008.
GSK's big institutional shareholders have held meetings with Gent and told him in no uncertain terms that Garnier's successor should be someone who is prepared to undertake a fundamental overhaul of the company and consider a radical streamlining of its operations, including a possible break-up.
The company, formed out of a merger between Glaxo and SmithKline in 2000, has been swept up in a tide of shareholder discontent with questions being asked about whether the giant pharmaceutical companies - Big Pharma - operate effectively and efficiently.
An analyst said: 'GSK is facing a backlash from investors who want the company to consider whether large, and sometimes cumbersome operations, such as GSK, are best placed to come up with new medicines.'
Shareholders want Garnier's successor to look at all options. These include: demerging manufacturing and/or the research and development arms, shrinking the firm's massive sales force, and offloading non-core operations such as the drinks subsidiary which owns brands including Ribena and Lucozade.
One institutional investor says: 'What we are telling the chairman is that with the industry facing a regulatory clampdown that makes it more difficult to get new medicines approved, GSK should look at ways to release shareholder value. The status quo is no longer an option.'
Another shareholder, who spoke on the basis of anonymity, says: 'GSK should recognise that Big Pharma is broken and needs to be fixed. Garnier's successor needs to take that on board. It's no good producing more of the same.'
Four potential candidates are jostling for the top job: David Stout, president of pharmaceutical operations; Chris Viehbacher, head of the US side, who is thought to be the frontrunner; Andrew Witty, the British head of European operations; and Russell Greig, head of the international division.
GSK's shares traded at close to £15 in early 2000 against a Friday close of £12.79. The stock price has been hit by safety fears linked to Avandia, one of its leading drugs, worries about generic competition and concern about a possible dearth of new blockbuster medicines in GSK's R&D pipeline.
Neil Ransome, head of the pharmaceuticals department at PricewaterhouseCoopers' corporate finance arm, said recently: 'Evidence that mega-mergers in this sector improve the rate of discovery of new drugs isn't compelling.'
Experts say the industry could move towards a model where companies farm out R&D to small biotech companies.
Analysts Citigroup shook the market earlier this year with research suggesting breaking up GSK could boost the value of the firm by half and enable the company to return £20bn to shareholders.
Email to the Delphi Centre
Following on from my previous post 'The Delphi Centre & GlaxoSmithKline Advertising' I felt the need to email The Delphi Centre to get some answers.
Here is my email:
----- Original Message -----
From: fiddaman
To: info@delphicentre.com.au
Sent: Sunday, September 02, 2007 10:22 AM
Subject: Sponsorship
Dear Sir/Madam,
For a website that proudly boasts the following:
"Over the last 16 years, they have designed various stress management programs and provide counselling and coaching."
I find it astonishing that you allow GlaxoSmithKline to blatantly advertise what is probably the most toxic drug of the past 50 years.
Why are you allowing GlaxoSmithKline to advertise Aropax on your following page?
http://www.delphicentre.com.au/conference/sponsors.htm
Surely this goes against everything that you stand for?
Was it a condition GlaxoSmithKline laid down to you regarding them sponsor your special events?
I am quite shocked by this and eagerly await your feedback on this very urgent matter.
Yours sincerely
Mr Robert Fiddaman
Seroxat/Aropax/Paxil Sufferers Blog
Here is my email:
----- Original Message -----
From: fiddaman
To: info@delphicentre.com.au
Sent: Sunday, September 02, 2007 10:22 AM
Subject: Sponsorship
Dear Sir/Madam,
For a website that proudly boasts the following:
"Over the last 16 years, they have designed various stress management programs and provide counselling and coaching."
I find it astonishing that you allow GlaxoSmithKline to blatantly advertise what is probably the most toxic drug of the past 50 years.
Why are you allowing GlaxoSmithKline to advertise Aropax on your following page?
http://www.delphicentre.com.au/conference/sponsors.htm
Surely this goes against everything that you stand for?
Was it a condition GlaxoSmithKline laid down to you regarding them sponsor your special events?
I am quite shocked by this and eagerly await your feedback on this very urgent matter.
Yours sincerely
Mr Robert Fiddaman
Seroxat/Aropax/Paxil Sufferers Blog
The Delphi Centre & GlaxoSmithKline Advertising
From the 'About Us' section on the Delphi Centre website:
The Delphi Centre, based in Melbourne Australia, draws its inspiration from a temple at Delphi in ancient Greece. Although famed for the wisdom of its Oracle, it relied on a timeless truth; that for every question or problem we experience, we have the capacity for creative resolution within ourselves.
Founders Susan Henry and Naomi Halpern have learned much about human potential and resilience. They have achieved international recognition for their pioneering work developing education, conferences and resources for Australia's health care profession in the field of trauma and extreme stress. Over the last 16 years, they have designed various stress management programs and provide counselling and coaching.
All well and good - I'm a firm beleiver in counselling before ramming pills into your mouth.
However, The Delphi Centre's co-principal sponsor is Pfizer not only that... the special event sponsor is none other than our good friends, GlaxoSmithKline. What amazes me is that the Delphi Centre's sponsors page not only lists GlaxoSmithKline as their 'special event sponsors' they also carry the GSK logo..... not so bad I hear you cry. Have a look and see what is next to the GSK logo though and maybe you will become outraged.
For a centre that provide stress management programs and provide counselling and coaching they quite clearly are giving off the wrong signals when they allow blatant advertising by one of their sponsors. You intrigued as to what this blatant advertising is?
Here's the GSK logo that runs on their webpage:
And here is what sits proudly next to it
For those who don't know, Aropax is the Australian name for Seroxat and Paxil.
Fid
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