Guest guest Posted December 12, 2004 Report Share Posted December 12, 2004 After reading the transcript of this program and actually poring over the documents that this evil Nazi company generated to cover-up the fact that they KNEW that Paxil was addictive, I can only say this: These bastards deserve to get skewered. And GSK, if you're reading this, and I know you are, I suggest that you never ever put that odious Dr. Wheadon in front of the public again. If ever there was a man who looked evil, oozed evil, and personified evil, it is this person, and I'm not the only one who thinks so. He needs to be hidden away, not making public statements that only give away your diabolical intent. You're going down GSK because you lied and you covered up this insidious deadly poison and its side effects. May every single one of you rot in hell, including that jackass who runs your company, J-P Garnier. A pox on all of you. Dec. 9, 2004 — New documents uncovered by ABC News suggest GlaxoKline, the maker of the popular antidepressant Paxil, failed to disclose important information about the possibility of an increased risk of suicidal behavior in some children taking the drug, as well as serious withdrawal symptoms when some patients stop taking Paxil. The new documents obtained by the ABC News program " Primetime Live " have never before been made public. Earlier this year, the Food and Drug Administration ordered manufacturers to place a warning in bold print on antidepressants, alerting consumers that the drugs can cause suicidal tendencies in children and teenagers. E-mail Us: Antidepressant Side Effects? Additional Information on Depression and Treatment [see the attached file] Paxil Sales Memo Business Plan Guide Money Bag Memo " Where's My Paxil! " PR Firm Memo [see the attached file] Drug Maker Withheld Paxil Study Data Does Chocolate Qualify as a Health Food? Flu Shot Supply Grows, but Demand Withers The FDA's move raised the issue of how much antidepressant manufacturers knew about this increased risk and when. While Congress and the FDA have held hearings questioning GlaxoKline and other drug manufacturers about suppressing studies that cast their products in a negative light, " Primetime Live " has obtained actual copies of GlaxoKline reports from its own internal studies. In these studies, some children showed the same types of suicidal thoughts and behaviors that parents had for years claimed their children were exhibiting. According to these documents, internal studies by GlaxoKline concluded that Paxil had little or no effect in treating depression in children and adolescents. And as far back as 1997, the company was aware of studies reporting suicide-related behaviors in young patients taking the drug. In spite of this information, GlaxoKline distributed a memo to its sales force in 2001 touting the drug's " remarkable efficacy and safety in the treatment of adolescent depression. " See the memo. Additionally, the internal documents reveal GlaxoKline had scientific evidence Paxil could cause mild to severe withdrawal symptoms in some patients when they abruptly stopped taking the drug. A document the company distributed to sales staff referred to " withdrawal symptoms " and said they included problems like dizziness, nausea, fatigue, insomnia and nightmares, but advised the sales representatives to use the less-alarming term " discontinuation symptoms. " The documents suggest GlaxoKline's sales strategy was to downplay this information in order to maintain its share of the billion-dollar antidepressant market. " This is about money, " said Rep. Henry Waxman, D-Calif., who is on a congressional committee investigating antidepressant manufacturers. " This is not about science, because what they're doing is withholding the scientific information, suppressing the studies that could have a negative impact on their sales and their profits. " Drug Maker Under Attack In addition to the investigation by Congress, the New York attorney general's office in June of this year leveled charges of consumer fraud against GlaxoKline. The lawsuit alleged that the drug giant repeatedly concealed information about Paxil from doctors. The attorney general's lawsuit noted that GlaxoKline conducted at least five studies of Paxil's use in children and adolescents, but the company only published one of these studies — a decision at the heart of the controversy. Central to the attorney general's allegations were two Paxil studies for depression in children and adolescents. ABC News has obtained original documents from those studies. In one study, referred to by the company as Study 377, researchers noted some children exhibiting suicidal behaviors and attempts to kill themselves. Referring to that study and another, Study 329, an internal GlaxoKline memo acknowledged that Paxil " failed to demonstrate a statistically significant difference from placebo on the primary efficacy measures. " [see the attached file] E-mail Us: Antidepressant Side Effects? Additional Information on Depression and Treatment [see the attached file] Paxil Sales Memo Business Plan Guide Money Bag Memo " Where's My Paxil! " PR Firm Memo [see the attached file] Drug Maker Withheld Paxil Study Data Does Chocolate Qualify as a Health Food? Flu Shot Supply Grows, but Demand Withers The same internal memo went on to identify a single goal: " to effectively manage the dissemination of these data in order to minimize any potential negative commercial impact. " The document recommends that the company not seek government approval for Paxil's efficacy or safety in treating depression in adolescents at that time because they believed that they would not get that approval and " it would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of [Paxil]. " Finally, the memo concludes, " Positive data from Study 329 will be published in abstract and a full manuscript of the 329 data will be progressed. " The results from Study 329 were ultimately published in the Journal of American Child Adolescent Psychiatry in 2001 with the conclusion " Paxil is generally well tolerated and effective for major depression in adolescents. " The New York attorney general criticized the publication of this article, saying, " Although it allowed the data from study 329 to be published, GlaxoKline concealed and suppressed studies 377 and 701, which failed to show that [Paxil] was more effective than placebo in treating [depression] in children and adolescents. " Nonetheless, a 2001 internal memo to the company's sales reps touted the study as showing Paxil is " truly a remarkable product that continues to demonstrate efficacy " in adolescents. See the memo. GlaxoKline says its reps were not supposed to discuss the memo with doctors and notes it was stamped " For representatives' information only, " but the New York attorney general's complaint charged that the company would only have sent the memo to its reps " to falsely characterize Study 329 in their communications with physicians. " GlaxoKline later settled the lawsuit, without an admission of wrongdoing, but paid a $2.5 million fine and promised to make all of its research available online. GlaxoKline defends its public disclosures regarding suicide risks, saying that in each individual pediatric study the numbers were too small to be statistically significant. GlaxoKline also claims that it wasn't until data were pooled from all antidepressant studies that the increased risk of suicide became clear. It and other drug companies also say there's no way to prove that any individual suicide-related behavior was caused by the drug and not the patient's underlying depression. The makers of Paxil, Effexor and Zoloft said they have not endorsed the use of their antidepressants in children or adolescents. They also point out that during their pediatric trials no one actually committed suicide. Downplaying Withdrawal SymptomsPaxil belongs to a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. Like other SSRIs, Paxil can cause withdrawal symptoms when patients stop using the drug. Until 2001 there was no clear warning or precaution in the prescribing information provided to doctors by GlaxoKline. In prescribing information up to December 2001, the company only mentioned " withdrawal syndrome " as a rare potential side effect associated with the nervous system, but without explaining what " withdrawal syndrome " is. GlaxoKline also mentioned spontaneous reports of " discontinuation symptoms, " but explained these reports " may have no causal relationship with the drug. " [see the attached file] E-mail Us: Antidepressant Side Effects? Additional Information on Depression and Treatment [see the attached file] Paxil Sales Memo Business Plan Guide Money Bag Memo " Where's My Paxil! " PR Firm Memo [see the attached file] Drug Maker Withheld Paxil Study Data Does Chocolate Qualify as a Health Food? Flu Shot Supply Grows, but Demand Withers But " Primetime Live " discovered an internal safety review dating from 1997 that provided scientific evidence from GlaxoKline studies of withdrawal effects caused by Paxil. There was never any mention of these studies and the specific results in any of the official prescribing information made available to American doctors and patients. Starting in December 2001, GlaxoKline included a precaution to make doctors and patients aware of some possible " discontinuation " side effects affecting " 2 percent or greater " of patients based on studies. According to the 1997 review, one study found that 25 percent of patients taking Paxil in one experienced discontinuation symptoms (vs. 5.9 percent for patients taking a placebo). In a study of patients with major depression, 42 percent of the patients taking Paxil experienced one discontinuation symptom. GlaxoKline told " Primetime Live " that " most of the individual studies have been made public either through publication in a peer-reviewed journal or presentation at a major medical meeting. " But none of the medical experts contacted by " Primetime Live " knew about this data, and GlaxoKline did not make those publications or presentations available, despite repeated requests. Despite these studies, these documents reveal that GlaxoKline instructed its sales force to downplay or minimize the negative effects of discontinuing Paxil from doctors A 1998 " business plan guide " for sales reps instructed them to " minimize concerns surrounding discontinuation symptoms. " Sales reps were also told to explain to doctors that the " discontinuation incident rate is two in 1,000 patients. " This rate is markedly different from the results of the studies in the safety review published nine months earlier. See the Business Plan Guide. In a company-sponsored education program for sales representatives, " withdrawal syndrome " was clearly defined as " a class effect that can occur when an SSRI is stopped abruptly. Symptoms may include asthenia, flu-like symptoms, fatigue, dizziness, nausea, and sleep disturbances (insomnia, vivid dreams or nightmares). " However, the next direction recommended reps avoid using the term: " instead of 'withdrawal syndrome,' which implies addictive properties, try to refer to this phenomenon as 'discontinuation symptoms.' " One vivid reminder of the importance of Paxil to GlaxoKline is found on a May 1997 sales memo. Sales reps are reminded, " Let's face it in the end. [sic] The only thing the anxious and agitated patient will be saying is: 'Where's my Paxil!!!!!!' " The comment is illustrated by a cartoon of a screaming woman. As if to underscore the importance of Paxil to GlaxoKline, another company sales document graphically explained why discontinuation is an issue. The answer: $1 billion, the total sales of Paxil and Seroxat (a related SSRI) as of September 1997. This statement is illustrated by a large, black money bag. See the " money bag " memo. [see the attached file] E-mail Us: Antidepressant Side Effects? Additional Information on Depression and Treatment [see the attached file] Paxil Sales Memo Business Plan Guide Money Bag Memo " Where's My Paxil! " PR Firm Memo [see the attached file] Drug Maker Withheld Paxil Study Data Does Chocolate Qualify as a Health Food? Flu Shot Supply Grows, but Demand Withers A Publishing Coincidence In a 1997 memo, a public relations firm working for GlaxoKline drafted a letter on the topic of discontinuation symptoms that was apparently intended for publication by a company spokesperson or possibly a physician. The memo explained that " complete duplication will look fishy if we decide to submit both. Are there other references we could draw on for the various drugs? At the very least, we can't have the references appear in the same order. " The draft letter listed three physicians as the intended senders, including Dr. Bruce Pollock of the University of Pittsburgh. A letter by Pollock appeared in the October 1998 issue of the Journal of Clinical Psychiatry. Although Pollock's letter was not the same as what the PR company drafted, it made nearly every point in the draft — almost in the same sequence. See the PR company's draft letter and Dr. Pollock's letter to the journal. Pollock, who was on the company's advisory board at the time, told " Primetime Live " he wrote the published letter and stands by its accuracy. He did say, however, he " could imagine a scenario where a representative from the makers of Paxil said, 'Could you make this point?' " because it was well-known that he had studied Paxil in elderly patients. But he denied that he had any knowledge of intentions to use his letter in a marketing plan, or that he had any knowledge of the draft letter prepared by the PR firm that included his name. This published letter resurfaced once again in the internal memorandum obtained by " Primetime Live. " The company's 1998 business plan guide for sales reps cited Pollock's letter as " an effective tool for addressing discontinuation. " GlaxoKline declined to comment on these documents, saying " it is difficult to respond to court documents taken out of context. " In court, they have said they provided adequate and complete warnings to physicians about the risks of withdrawal. In a letter to " Primetime Live, " they also said the majority of patients who experience any symptoms have mild to moderate symptoms that are usually self-limiting within two weeks. ABCNEWS' Greg Fisher, Kate Sheekey, Kim Launier and Marc Lallanilla contributed to this report. " Blind Reason " a novel of pharmaceutical intrigue Think your antidepressant is safe? Think again. It's Unsafe At Any Dose Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 12, 2004 Report Share Posted December 12, 2004 Glitter If I were where you are I'd hug you right now. (No Offense) One thing I'd like to know is how much the kickbacks were to DR's for prescribing this toxic waste. If there is one among them that can stand up like a descent human being should and expose the company and their poison for what it really is and what it does I'd like to see you step up NOW. I'll promise all of them one thing they'll answer to GOD for what they're doing to people on a daily basis and I wouldn't want to be in their shoes when that time comes. I'll shut up for now Charlie > After reading the transcript of this program and actually poring over the > documents that this evil Nazi company generated to cover-up the fact that they > KNEW that Paxil was addictive, I can only say this: These bastards deserve to > get skewered. And GSK, if you're reading this, and I know you are, I suggest > that you never ever put that odious Dr. Wheadon in front of the public > again. If ever there was a man who looked evil, oozed evil, and personified > evil, it is this person, and I'm not the only one who thinks so. He needs to be > hidden away, not making public statements that only give away your diabolical > intent. You're going down GSK because you lied and you covered up this > insidious deadly poison and its side effects. May every single one of you rot in > hell, including that jackass who runs your company, J-P Garnier. A pox on all > of you. > > > Dec. 9, 2004 †" New documents uncovered by ABC News suggest GlaxoKline, > the maker of the popular antidepressant Paxil, failed to disclose important > information about the possibility of an increased risk of suicidal behavior in > some children taking the drug, as well as serious withdrawal symptoms when some > patients stop taking Paxil. The new documents obtained by the ABC News program > " Primetime Live " have never before been made public. Earlier this year, the > Food and Drug Administration ordered manufacturers to place a warning in bold > print on antidepressants, alerting consumers that the drugs can cause suicidal > tendencies in children and teenagers. > E-mail Us: Antidepressant Side Effects? > Additional Information on Depression and Treatment [see the attached file] > Paxil Sales Memo > Business Plan Guide > Money Bag Memo > " Where's My Paxil! " > PR Firm Memo [see the attached file] > Drug Maker Withheld Paxil Study Data > Does Chocolate Qualify as a Health Food? > Flu Shot Supply Grows, but Demand Withers The FDA's move raised the issue of > how much antidepressant manufacturers knew about this increased risk and when. > While Congress and the FDA have held hearings questioning GlaxoKline and > other drug manufacturers about suppressing studies that cast their products > in a negative light, " Primetime Live " has obtained actual copies of > GlaxoKline reports from its own internal studies. In these studies, some children > showed the same types of suicidal thoughts and behaviors that parents had for > years claimed their children were exhibiting. According to these documents, > internal studies by GlaxoKline concluded that Paxil had little or no effect > in treating depression in children and adolescents. And as far back as 1997, > the company was aware of studies reporting suicide-related behaviors in young > patients taking the drug. In spite of this information, GlaxoKline > distributed a memo to its sales force in 2001 touting the drug's " remarkable efficacy > and safety in the treatment of adolescent depression. " See the memo. > Additionally, the internal documents reveal GlaxoKline had scientific evidence > Paxil could cause mild to severe withdrawal symptoms in some patients when they > abruptly stopped taking the drug. A document the company distributed to sales > staff referred to " withdrawal symptoms " and said they included problems like > dizziness, nausea, fatigue, insomnia and nightmares, but advised the sales > representatives to use the less-alarming term " discontinuation symptoms. " The > documents suggest GlaxoKline's sales strategy was to downplay this information > in order to maintain its share of the billion-dollar antidepressant market. > " This is about money, " said Rep. Henry Waxman, D-Calif., who is on a > congressional committee investigating antidepressant manufacturers. " This is not about > science, because what they're doing is withholding the scientific information, > suppressing the studies that could have a negative impact on their sales and > their profits. " Drug Maker Under Attack In addition to the investigation by > Congress, the New York attorney general's office in June of this year leveled > charges of consumer fraud against GlaxoKline. The lawsuit alleged that the > drug giant repeatedly concealed information about Paxil from doctors. The > attorney general's lawsuit noted that GlaxoKline conducted at least five > studies of Paxil's use in children and adolescents, but the company only published > one of these studies †" a decision at the heart of the controversy. Central to > the attorney general's allegations were two Paxil studies for depression in > children and adolescents. ABC News has obtained original documents from those > studies. In one study, referred to by the company as Study 377, researchers noted > some children exhibiting suicidal behaviors and attempts to kill themselves. > Referring to that study and another, Study 329, an internal GlaxoKline > memo acknowledged that Paxil " failed to demonstrate a statistically significant > difference from placebo on the primary efficacy measures. " [see the attached > file] > E-mail Us: Antidepressant Side Effects? > Additional Information on Depression and Treatment [see the attached file] > Paxil Sales Memo > Business Plan Guide > Money Bag Memo > " Where's My Paxil! " > PR Firm Memo [see the attached file] > Drug Maker Withheld Paxil Study Data > Does Chocolate Qualify as a Health Food? > Flu Shot Supply Grows, but Demand Withers The same internal memo went on to > identify a single goal: " to effectively manage the dissemination of these data > in order to minimize any potential negative commercial impact. " The document > recommends that the company not seek government approval for Paxil's efficacy > or safety in treating depression in adolescents at that time because they > believed that they would not get that approval and " it would be commercially > unacceptable to include a statement that efficacy had not been demonstrated, as this > would undermine the profile of [Paxil]. " Finally, the memo concludes, > " Positive data from Study 329 will be published in abstract and a full manuscript of > the 329 data will be progressed. " The results from Study 329 were ultimately > published in the Journal of American Child Adolescent Psychiatry in 2001 with > the conclusion " Paxil is generally well tolerated and effective for major > depression in adolescents. " The New York attorney general criticized the > publication of this article, saying, " Although it allowed the data from study 329 to be > published, GlaxoKline concealed and suppressed studies 377 and 701, which > failed to show that [Paxil] was more effective than placebo in treating > [depression] in children and adolescents. " Nonetheless, a 2001 internal memo to the > company's sales reps touted the study as showing Paxil is " truly a remarkable > product that continues to demonstrate efficacy " in adolescents. See the memo. > GlaxoKline says its reps were not supposed to discuss the memo with > doctors and notes it was stamped " For representatives' information only, " but the > New York attorney general's complaint charged that the company would only have > sent the memo to its reps " to falsely characterize Study 329 in their > communications with physicians. " GlaxoKline later settled the lawsuit, without > an admission of wrongdoing, but paid a $2.5 million fine and promised to make > all of its research available online. GlaxoKline defends its public > disclosures regarding suicide risks, saying that in each individual pediatric study > the numbers were too small to be statistically significant. GlaxoKline > also claims that it wasn't until data were pooled from all antidepressant > studies that the increased risk of suicide became clear. It and other drug companies > also say there's no way to prove that any individual suicide- related behavior > was caused by the drug and not the patient's underlying depression. The > makers of Paxil, Effexor and Zoloft said they have not endorsed the use of their > antidepressants in children or adolescents. They also point out that during > their pediatric trials no one actually committed suicide. Downplaying Withdrawal > SymptomsPaxil belongs to a class of antidepressants known as selective > serotonin reuptake inhibitors, or SSRIs. Like other SSRIs, Paxil can cause withdrawal > symptoms when patients stop using the drug. Until 2001 there was no clear > warning or precaution in the prescribing information provided to doctors by > GlaxoKline. In prescribing information up to December 2001, the company only > mentioned " withdrawal syndrome " as a rare potential side effect associated with > the nervous system, but without explaining what " withdrawal syndrome " is. > GlaxoKline also mentioned spontaneous reports of " discontinuation symptoms, " > but explained these reports " may have no causal relationship with the drug. " > [see the attached file] > E-mail Us: Antidepressant Side Effects? > Additional Information on Depression and Treatment [see the attached file] > Paxil Sales Memo > Business Plan Guide > Money Bag Memo > " Where's My Paxil! " > PR Firm Memo [see the attached file] > Drug Maker Withheld Paxil Study Data > Does Chocolate Qualify as a Health Food? > Flu Shot Supply Grows, but Demand Withers But " Primetime Live " discovered an > internal safety review dating from 1997 that provided scientific evidence from > GlaxoKline studies of withdrawal effects caused by Paxil. There was > never any mention of these studies and the specific results in any of the official > prescribing information made available to American doctors and patients. > Starting in December 2001, GlaxoKline included a precaution to make doctors > and patients aware of some possible " discontinuation " side effects affecting " 2 > percent or greater " of patients based on studies. According to the 1997 > review, one study found that 25 percent of patients taking Paxil in one experienced > discontinuation symptoms (vs. 5.9 percent for patients taking a placebo). In > a study of patients with major depression, 42 percent of the patients taking > Paxil experienced one discontinuation symptom. GlaxoKline told " Primetime > Live " that " most of the individual studies have been made public either > through publication in a peer-reviewed journal or presentation at a major medical > meeting. " But none of the medical experts contacted by " Primetime Live " knew > about this data, and GlaxoKline did not make those publications or > presentations available, despite repeated requests. Despite these studies, these > documents reveal that GlaxoKline instructed its sales force to downplay or > minimize the negative effects of discontinuing Paxil from doctors A 1998 " business > plan guide " for sales reps instructed them to " minimize concerns surrounding > discontinuation symptoms. " Sales reps were also told to explain to doctors > that the " discontinuation incident rate is two in 1,000 patients. " This rate is > markedly different from the results of the studies in the safety review > published nine months earlier. See the Business Plan Guide. In a company-sponsored > education program for sales representatives, " withdrawal syndrome " was clearly > defined as " a class effect that can occur when an SSRI is stopped abruptly. > Symptoms may include asthenia, flu-like symptoms, fatigue, dizziness, nausea, and > sleep disturbances (insomnia, vivid dreams or nightmares). " However, the next > direction recommended reps avoid using the term: " instead of 'withdrawal > syndrome,' which implies addictive properties, try to refer to this phenomenon as > 'discontinuation symptoms.' " One vivid reminder of the importance of Paxil to > GlaxoKline is found on a May 1997 sales memo. Sales reps are reminded, > " Let's face it in the end. [sic] The only thing the anxious and agitated patient > will be saying is: 'Where's my Paxil!!!!!!' " The comment is illustrated by a > cartoon of a screaming woman. As if to underscore the importance of Paxil to > GlaxoKline, another company sales document graphically explained why > discontinuation is an issue. The answer: $1 billion, the total sales of Paxil and > Seroxat (a related SSRI) as of September 1997. This statement is illustrated by > a large, black money bag. See the " money bag " memo. [see the attached file] > E-mail Us: Antidepressant Side Effects? > Additional Information on Depression and Treatment [see the attached file] > Paxil Sales Memo > Business Plan Guide > Money Bag Memo > " Where's My Paxil! " > PR Firm Memo [see the attached file] > Drug Maker Withheld Paxil Study Data > Does Chocolate Qualify as a Health Food? > Flu Shot Supply Grows, but Demand Withers A Publishing Coincidence In a 1997 > memo, a public relations firm working for GlaxoKline drafted a letter on > the topic of discontinuation symptoms that was apparently intended for > publication by a company spokesperson or possibly a physician. The memo explained > that " complete duplication will look fishy if we decide to submit both. Are there > other references we could draw on for the various drugs? At the very least, > we can't have the references appear in the same order. " The draft letter listed > three physicians as the intended senders, including Dr. Bruce Pollock of the > University of Pittsburgh. A letter by Pollock appeared in the October 1998 > issue of the Journal of Clinical Psychiatry. Although Pollock's letter was not > the same as what the PR company drafted, it made nearly every point in the draft > †" almost in the same sequence. See the PR company's draft letter and Dr. > Pollock's letter to the journal. Pollock, who was on the company's advisory board > at the time, told " Primetime Live " he wrote the published letter and stands by > its accuracy. He did say, however, he " could imagine a scenario where a > representative from the makers of Paxil said, 'Could you make this point?' " because > it was well-known that he had studied Paxil in elderly patients. But he > denied that he had any knowledge of intentions to use his letter in a marketing > plan, or that he had any knowledge of the draft letter prepared by the PR firm > that included his name. This published letter resurfaced once again in the > internal memorandum obtained by " Primetime Live. " The company's 1998 business plan > guide for sales reps cited Pollock's letter as " an effective tool for > addressing discontinuation. " GlaxoKline declined to comment on these documents, > saying " it is difficult to respond to court documents taken out of context. " In > court, they have said they provided adequate and complete warnings to > physicians about the risks of withdrawal. In a letter to " Primetime Live, " they also > said the majority of patients who experience any symptoms have mild to > moderate symptoms that are usually self-limiting within two weeks. ABCNEWS' Greg > Fisher, Kate Sheekey, Kim Launier and Marc Lallanilla contributed to this report. > > > > > > > " Blind Reason " > a novel of pharmaceutical intrigue > Think your antidepressant is safe? Think again. It's > Unsafe At Any Dose > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 13, 2004 Report Share Posted December 13, 2004 Glitter why do you say that they would be reading this ? also what is a pox... Re: GSK and PrimeTime After reading the transcript of this program and actually poring over the documents that this evil Nazi company generated to cover-up the fact that they KNEW that Paxil was addictive, I can only say this: These bastards deserve to get skewered. And GSK, if you're reading this, and I know you are, I suggest that you never ever put that odious Dr. Wheadon in front of the public again. If ever there was a man who looked evil, oozed evil, and personified evil, it is this person, and I'm not the only one who thinks so. He needs to be hidden away, not making public statements that only give away your diabolical intent. You're going down GSK because you lied and you covered up this insidious deadly poison and its side effects. May every single one of you rot in hell, including that jackass who runs your company, J-P Garnier. A pox on all of you. Dec. 9, 2004 — New documents uncovered by ABC News suggest GlaxoKline, the maker of the popular antidepressant Paxil, failed to disclose important information about the possibility of an increased risk of suicidal behavior in some children taking the drug, as well as serious withdrawal symptoms when some patients stop taking Paxil. The new documents obtained by the ABC News program " Primetime Live " have never before been made public. Earlier this year, the Food and Drug Administration ordered manufacturers to place a warning in bold print on antidepressants, alerting consumers that the drugs can cause suicidal tendencies in children and teenagers. E-mail Us: Antidepressant Side Effects? Additional Information on Depression and Treatment [see the attached file] Paxil Sales Memo Business Plan Guide Money Bag Memo " Where's My Paxil! " PR Firm Memo [see the attached file] Drug Maker Withheld Paxil Study Data Does Chocolate Qualify as a Health Food? Flu Shot Supply Grows, but Demand Withers The FDA's move raised the issue of how much antidepressant manufacturers knew about this increased risk and when. While Congress and the FDA have held hearings questioning GlaxoKline and other drug manufacturers about suppressing studies that cast their products in a negative light, " Primetime Live " has obtained actual copies of GlaxoKline reports from its own internal studies. In these studies, some children showed the same types of suicidal thoughts and behaviors that parents had for years claimed their children were exhibiting. According to these documents, internal studies by GlaxoKline concluded that Paxil had little or no effect in treating depression in children and adolescents. And as far back as 1997, the company was aware of studies reporting suicide-related behaviors in young patients taking the drug. In spite of this information, GlaxoKline distributed a memo to its sales force in 2001 touting the drug's " remarkable efficacy and safety in the treatment of adolescent depression. " See the memo. Additionally, the internal documents reveal GlaxoKline had scientific evidence Paxil could cause mild to severe withdrawal symptoms in some patients when they abruptly stopped taking the drug. A document the company distributed to sales staff referred to " withdrawal symptoms " and said they included problems like dizziness, nausea, fatigue, insomnia and nightmares, but advised the sales representatives to use the less-alarming term " discontinuation symptoms. " The documents suggest GlaxoKline's sales strategy was to downplay this information in order to maintain its share of the billion-dollar antidepressant market. " This is about money, " said Rep. Henry Waxman, D-Calif., who is on a congressional committee investigating antidepressant manufacturers. " This is not about science, because what they're doing is withholding the scientific information, suppressing the studies that could have a negative impact on their sales and their profits. " Drug Maker Under Attack In addition to the investigation by Congress, the New York attorney general's office in June of this year leveled charges of consumer fraud against GlaxoKline. The lawsuit alleged that the drug giant repeatedly concealed information about Paxil from doctors. The attorney general's lawsuit noted that GlaxoKline conducted at least five studies of Paxil's use in children and adolescents, but the company only published one of these studies — a decision at the heart of the controversy. Central to the attorney general's allegations were two Paxil studies for depression in children and adolescents. ABC News has obtained original documents from those studies. In one study, referred to by the company as Study 377, researchers noted some children exhibiting suicidal behaviors and attempts to kill themselves. Referring to that study and another, Study 329, an internal GlaxoKline memo acknowledged that Paxil " failed to demonstrate a statistically significant difference from placebo on the primary efficacy measures. " [see the attached file] E-mail Us: Antidepressant Side Effects? Additional Information on Depression and Treatment [see the attached file] Paxil Sales Memo Business Plan Guide Money Bag Memo " Where's My Paxil! " PR Firm Memo [see the attached file] Drug Maker Withheld Paxil Study Data Does Chocolate Qualify as a Health Food? Flu Shot Supply Grows, but Demand Withers The same internal memo went on to identify a single goal: " to effectively manage the dissemination of these data in order to minimize any potential negative commercial impact. " The document recommends that the company not seek government approval for Paxil's efficacy or safety in treating depression in adolescents at that time because they believed that they would not get that approval and " it would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of [Paxil]. " Finally, the memo concludes, " Positive data from Study 329 will be published in abstract and a full manuscript of the 329 data will be progressed. " The results from Study 329 were ultimately published in the Journal of American Child Adolescent Psychiatry in 2001 with the conclusion " Paxil is generally well tolerated and effective for major depression in adolescents. " The New York attorney general criticized the publication of this article, saying, " Although it allowed the data from study 329 to be published, GlaxoKline concealed and suppressed studies 377 and 701, which failed to show that [Paxil] was more effective than placebo in treating [depression] in children and adolescents. " Nonetheless, a 2001 internal memo to the company's sales reps touted the study as showing Paxil is " truly a remarkable product that continues to demonstrate efficacy " in adolescents. See the memo. GlaxoKline says its reps were not supposed to discuss the memo with doctors and notes it was stamped " For representatives' information only, " but the New York attorney general's complaint charged that the company would only have sent the memo to its reps " to falsely characterize Study 329 in their communications with physicians. " GlaxoKline later settled the lawsuit, without an admission of wrongdoing, but paid a $2.5 million fine and promised to make all of its research available online. GlaxoKline defends its public disclosures regarding suicide risks, saying that in each individual pediatric study the numbers were too small to be statistically significant. GlaxoKline also claims that it wasn't until data were pooled from all antidepressant studies that the increased risk of suicide became clear. It and other drug companies also say there's no way to prove that any individual suicide-related behavior was caused by the drug and not the patient's underlying depression. The makers of Paxil, Effexor and Zoloft said they have not endorsed the use of their antidepressants in children or adolescents. They also point out that during their pediatric trials no one actually committed suicide. Downplaying Withdrawal SymptomsPaxil belongs to a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. Like other SSRIs, Paxil can cause withdrawal symptoms when patients stop using the drug. Until 2001 there was no clear warning or precaution in the prescribing information provided to doctors by GlaxoKline. In prescribing information up to December 2001, the company only mentioned " withdrawal syndrome " as a rare potential side effect associated with the nervous system, but without explaining what " withdrawal syndrome " is. GlaxoKline also mentioned spontaneous reports of " discontinuation symptoms, " but explained these reports " may have no causal relationship with the drug. " [see the attached file] E-mail Us: Antidepressant Side Effects? Additional Information on Depression and Treatment [see the attached file] Paxil Sales Memo Business Plan Guide Money Bag Memo " Where's My Paxil! " PR Firm Memo [see the attached file] Drug Maker Withheld Paxil Study Data Does Chocolate Qualify as a Health Food? Flu Shot Supply Grows, but Demand Withers But " Primetime Live " discovered an internal safety review dating from 1997 that provided scientific evidence from GlaxoKline studies of withdrawal effects caused by Paxil. There was never any mention of these studies and the specific results in any of the official prescribing information made available to American doctors and patients. Starting in December 2001, GlaxoKline included a precaution to make doctors and patients aware of some possible " discontinuation " side effects affecting " 2 percent or greater " of patients based on studies. According to the 1997 review, one study found that 25 percent of patients taking Paxil in one experienced discontinuation symptoms (vs. 5.9 percent for patients taking a placebo). In a study of patients with major depression, 42 percent of the patients taking Paxil experienced one discontinuation symptom. GlaxoKline told " Primetime Live " that " most of the individual studies have been made public either through publication in a peer-reviewed journal or presentation at a major medical meeting. " But none of the medical experts contacted by " Primetime Live " knew about this data, and GlaxoKline did not make those publications or presentations available, despite repeated requests. Despite these studies, these documents reveal that GlaxoKline instructed its sales force to downplay or minimize the negative effects of discontinuing Paxil from doctors A 1998 " business plan guide " for sales reps instructed them to " minimize concerns surrounding discontinuation symptoms. " Sales reps were also told to explain to doctors that the " discontinuation incident rate is two in 1,000 patients. " This rate is markedly different from the results of the studies in the safety review published nine months earlier. See the Business Plan Guide. In a company-sponsored education program for sales representatives, " withdrawal syndrome " was clearly defined as " a class effect that can occur when an SSRI is stopped abruptly. Symptoms may include asthenia, flu-like symptoms, fatigue, dizziness, nausea, and sleep disturbances (insomnia, vivid dreams or nightmares). " However, the next direction recommended reps avoid using the term: " instead of 'withdrawal syndrome,' which implies addictive properties, try to refer to this phenomenon as 'discontinuation symptoms.' " One vivid reminder of the importance of Paxil to GlaxoKline is found on a May 1997 sales memo. Sales reps are reminded, " Let's face it in the end. [sic] The only thing the anxious and agitated patient will be saying is: 'Where's my Paxil!!!!!!' " The comment is illustrated by a cartoon of a screaming woman. As if to underscore the importance of Paxil to GlaxoKline, another company sales document graphically explained why discontinuation is an issue. The answer: $1 billion, the total sales of Paxil and Seroxat (a related SSRI) as of September 1997. This statement is illustrated by a large, black money bag. See the " money bag " memo. [see the attached file] E-mail Us: Antidepressant Side Effects? Additional Information on Depression and Treatment [see the attached file] Paxil Sales Memo Business Plan Guide Money Bag Memo " Where's My Paxil! " PR Firm Memo [see the attached file] Drug Maker Withheld Paxil Study Data Does Chocolate Qualify as a Health Food? Flu Shot Supply Grows, but Demand Withers A Publishing Coincidence In a 1997 memo, a public relations firm working for GlaxoKline drafted a letter on the topic of discontinuation symptoms that was apparently intended for publication by a company spokesperson or possibly a physician. The memo explained that " complete duplication will look fishy if we decide to submit both. Are there other references we could draw on for the various drugs? At the very least, we can't have the references appear in the same order. " The draft letter listed three physicians as the intended senders, including Dr. Bruce Pollock of the University of Pittsburgh. A letter by Pollock appeared in the October 1998 issue of the Journal of Clinical Psychiatry. Although Pollock's letter was not the same as what the PR company drafted, it made nearly every point in the draft — almost in the same sequence. See the PR company's draft letter and Dr. Pollock's letter to the journal. Pollock, who was on the company's advisory board at the time, told " Primetime Live " he wrote the published letter and stands by its accuracy. He did say, however, he " could imagine a scenario where a representative from the makers of Paxil said, 'Could you make this point?' " because it was well-known that he had studied Paxil in elderly patients. But he denied that he had any knowledge of intentions to use his letter in a marketing plan, or that he had any knowledge of the draft letter prepared by the PR firm that included his name. This published letter resurfaced once again in the internal memorandum obtained by " Primetime Live. " The company's 1998 business plan guide for sales reps cited Pollock's letter as " an effective tool for addressing discontinuation. " GlaxoKline declined to comment on these documents, saying " it is difficult to respond to court documents taken out of context. " In court, they have said they provided adequate and complete warnings to physicians about the risks of withdrawal. In a letter to " Primetime Live, " they also said the majority of patients who experience any symptoms have mild to moderate symptoms that are usually self-limiting within two weeks. ABCNEWS' Greg Fisher, Kate Sheekey, Kim Launier and Marc Lallanilla contributed to this report. " Blind Reason " a novel of pharmaceutical intrigue Think your antidepressant is safe? Think again. It's Unsafe At Any Dose Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 13, 2004 Report Share Posted December 13, 2004 A pox is: pox noun 1. venereal disease: a venereal disease, especially syphilis ( informal ) 2. disease causing spots on skin: a viral disease such as smallpox or chickenpox that causes pus-filled blisters (pustules) to form on the skin, and often leaves scars (pockmarks) [Alteration of the plural of pock] a pox on somebody or something used to express a wish that misfortune will come to somebody or something (archaic) Best, Jim you also can lookup words! www.onelook.com is the gateway to understanding Jim Glitter why do you say that they would be reading this ? also what is a pox... Re: GSK and PrimeTime After reading the transcript of this program and actually poring over the documents that this evil Nazi company generated to cover-up the fact that they KNEW that Paxil was addictive, I can only say this: These bastards deserve to get skewered. And GSK, if you're reading this, and I know you are, I suggest that you never ever put that odious Dr. Wheadon in front of the public again. If ever there was a man who looked evil, oozed evil, and personified evil, it is this person, and I'm not the only one who thinks so. He needs to be hidden away, not making public statements that only give away your diabolical intent. You're going down GSK because you lied and you covered up this insidious deadly poison and its side effects. May every single one of you rot in hell, including that jackass who runs your company, J-P Garnier. A pox on all of you. Dec. 9, 2004 — New documents uncovered by ABC News suggest GlaxoKline, the maker of the popular antidepressant Paxil, failed to disclose important information about the possibility of an increased risk of suicidal behavior in some children taking the drug, as well as serious withdrawal symptoms when some patients stop taking Paxil. The new documents obtained by the ABC News program " Primetime Live " have never before been made public. Earlier this year, the Food and Drug Administration ordered manufacturers to place a warning in bold print on antidepressants, alerting consumers that the drugs can cause suicidal tendencies in children and teenagers. E-mail Us: Antidepressant Side Effects? Additional Information on Depression and Treatment [see the attached file] Paxil Sales Memo Business Plan Guide Money Bag Memo " Where's My Paxil! " PR Firm Memo [see the attached file] Drug Maker Withheld Paxil Study Data Does Chocolate Qualify as a Health Food? Flu Shot Supply Grows, but Demand Withers The FDA's move raised the issue of how much antidepressant manufacturers knew about this increased risk and when. While Congress and the FDA have held hearings questioning GlaxoKline and other drug manufacturers about suppressing studies that cast their products in a negative light, " Primetime Live " has obtained actual copies of GlaxoKline reports from its own internal studies. In these studies, some children showed the same types of suicidal thoughts and behaviors that parents had for years claimed their children were exhibiting. According to these documents, internal studies by GlaxoKline concluded that Paxil had little or no effect in treating depression in children and adolescents. And as far back as 1997, the company was aware of studies reporting suicide-related behaviors in young patients taking the drug. In spite of this information, GlaxoKline distributed a memo to its sales force in 2001 touting the drug's " remarkable efficacy and safety in the treatment of adolescent depression. " See the memo. Additionally, the internal documents reveal GlaxoKline had scientific evidence Paxil could cause mild to severe withdrawal symptoms in some patients when they abruptly stopped taking the drug. A document the company distributed to sales staff referred to " withdrawal symptoms " and said they included problems like dizziness, nausea, fatigue, insomnia and nightmares, but advised the sales representatives to use the less-alarming term " discontinuation symptoms. " The documents suggest GlaxoKline's sales strategy was to downplay this information in order to maintain its share of the billion-dollar antidepressant market. " This is about money, " said Rep. Henry Waxman, D-Calif., who is on a congressional committee investigating antidepressant manufacturers. " This is not about science, because what they're doing is withholding the scientific information, suppressing the studies that could have a negative impact on their sales and their profits. " Drug Maker Under Attack In addition to the investigation by Congress, the New York attorney general's office in June of this year leveled charges of consumer fraud against GlaxoKline. The lawsuit alleged that the drug giant repeatedly concealed information about Paxil from doctors. The attorney general's lawsuit noted that GlaxoKline conducted at least five studies of Paxil's use in children and adolescents, but the company only published one of these studies — a decision at the heart of the controversy. Central to the attorney general's allegations were two Paxil studies for depression in children and adolescents. ABC News has obtained original documents from those studies. In one study, referred to by the company as Study 377, researchers noted some children exhibiting suicidal behaviors and attempts to kill themselves. Referring to that study and another, Study 329, an internal GlaxoKline memo acknowledged that Paxil " failed to demonstrate a statistically significant difference from placebo on the primary efficacy measures. " [see the attached file] E-mail Us: Antidepressant Side Effects? Additional Information on Depression and Treatment [see the attached file] Paxil Sales Memo Business Plan Guide Money Bag Memo " Where's My Paxil! " PR Firm Memo [see the attached file] Drug Maker Withheld Paxil Study Data Does Chocolate Qualify as a Health Food? Flu Shot Supply Grows, but Demand Withers The same internal memo went on to identify a single goal: " to effectively manage the dissemination of these data in order to minimize any potential negative commercial impact. " The document recommends that the company not seek government approval for Paxil's efficacy or safety in treating depression in adolescents at that time because they believed that they would not get that approval and " it would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of [Paxil]. " Finally, the memo concludes, " Positive data from Study 329 will be published in abstract and a full manuscript of the 329 data will be progressed. " The results from Study 329 were ultimately published in the Journal of American Child Adolescent Psychiatry in 2001 with the conclusion " Paxil is generally well tolerated and effective for major depression in adolescents. " The New York attorney general criticized the publication of this article, saying, " Although it allowed the data from study 329 to be published, GlaxoKline concealed and suppressed studies 377 and 701, which failed to show that [Paxil] was more effective than placebo in treating [depression] in children and adolescents. " Nonetheless, a 2001 internal memo to the company's sales reps touted the study as showing Paxil is " truly a remarkable product that continues to demonstrate efficacy " in adolescents. See the memo. GlaxoKline says its reps were not supposed to discuss the memo with doctors and notes it was stamped " For representatives' information only, " but the New York attorney general's complaint charged that the company would only have sent the memo to its reps " to falsely characterize Study 329 in their communications with physicians. " GlaxoKline later settled the lawsuit, without an admission of wrongdoing, but paid a $2.5 million fine and promised to make all of its research available online. GlaxoKline defends its public disclosures regarding suicide risks, saying that in each individual pediatric study the numbers were too small to be statistically significant. GlaxoKline also claims that it wasn't until data were pooled from all antidepressant studies that the increased risk of suicide became clear. It and other drug companies also say there's no way to prove that any individual suicide-related behavior was caused by the drug and not the patient's underlying depression. The makers of Paxil, Effexor and Zoloft said they have not endorsed the use of their antidepressants in children or adolescents. They also point out that during their pediatric trials no one actually committed suicide. Downplaying Withdrawal SymptomsPaxil belongs to a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. Like other SSRIs, Paxil can cause withdrawal symptoms when patients stop using the drug. Until 2001 there was no clear warning or precaution in the prescribing information provided to doctors by GlaxoKline. In prescribing information up to December 2001, the company only mentioned " withdrawal syndrome " as a rare potential side effect associated with the nervous system, but without explaining what " withdrawal syndrome " is. GlaxoKline also mentioned spontaneous reports of " discontinuation symptoms, " but explained these reports " may have no causal relationship with the drug. " [see the attached file] E-mail Us: Antidepressant Side Effects? Additional Information on Depression and Treatment [see the attached file] Paxil Sales Memo Business Plan Guide Money Bag Memo " Where's My Paxil! " PR Firm Memo [see the attached file] Drug Maker Withheld Paxil Study Data Does Chocolate Qualify as a Health Food? Flu Shot Supply Grows, but Demand Withers But " Primetime Live " discovered an internal safety review dating from 1997 that provided scientific evidence from GlaxoKline studies of withdrawal effects caused by Paxil. There was never any mention of these studies and the specific results in any of the official prescribing information made available to American doctors and patients. Starting in December 2001, GlaxoKline included a precaution to make doctors and patients aware of some possible " discontinuation " side effects affecting " 2 percent or greater " of patients based on studies. According to the 1997 review, one study found that 25 percent of patients taking Paxil in one experienced discontinuation symptoms (vs. 5.9 percent for patients taking a placebo). In a study of patients with major depression, 42 percent of the patients taking Paxil experienced one discontinuation symptom. GlaxoKline told " Primetime Live " that " most of the individual studies have been made public either through publication in a peer-reviewed journal or presentation at a major medical meeting. " But none of the medical experts contacted by " Primetime Live " knew about this data, and GlaxoKline did not make those publications or presentations available, despite repeated requests. Despite these studies, these documents reveal that GlaxoKline instructed its sales force to downplay or minimize the negative effects of discontinuing Paxil from doctors A 1998 " business plan guide " for sales reps instructed them to " minimize concerns surrounding discontinuation symptoms. " Sales reps were also told to explain to doctors that the " discontinuation incident rate is two in 1,000 patients. " This rate is markedly different from the results of the studies in the safety review published nine months earlier. See the Business Plan Guide. In a company-sponsored education program for sales representatives, " withdrawal syndrome " was clearly defined as " a class effect that can occur when an SSRI is stopped abruptly. Symptoms may include asthenia, flu-like symptoms, fatigue, dizziness, nausea, and sleep disturbances (insomnia, vivid dreams or nightmares). " However, the next direction recommended reps avoid using the term: " instead of 'withdrawal syndrome,' which implies addictive properties, try to refer to this phenomenon as 'discontinuation symptoms.' " One vivid reminder of the importance of Paxil to GlaxoKline is found on a May 1997 sales memo. Sales reps are reminded, " Let's face it in the end. [sic] The only thing the anxious and agitated patient will be saying is: 'Where's my Paxil!!!!!!' " The comment is illustrated by a cartoon of a screaming woman. As if to underscore the importance of Paxil to GlaxoKline, another company sales document graphically explained why discontinuation is an issue. The answer: $1 billion, the total sales of Paxil and Seroxat (a related SSRI) as of September 1997. This statement is illustrated by a large, black money bag. See the " money bag " memo. [see the attached file] E-mail Us: Antidepressant Side Effects? Additional Information on Depression and Treatment [see the attached file] Paxil Sales Memo Business Plan Guide Money Bag Memo " Where's My Paxil! " PR Firm Memo [see the attached file] Drug Maker Withheld Paxil Study Data Does Chocolate Qualify as a Health Food? Flu Shot Supply Grows, but Demand Withers A Publishing Coincidence In a 1997 memo, a public relations firm working for GlaxoKline drafted a letter on the topic of discontinuation symptoms that was apparently intended for publication by a company spokesperson or possibly a physician. The memo explained that " complete duplication will look fishy if we decide to submit both. Are there other references we could draw on for the various drugs? At the very least, we can't have the references appear in the same order. " The draft letter listed three physicians as the intended senders, including Dr. Bruce Pollock of the University of Pittsburgh. A letter by Pollock appeared in the October 1998 issue of the Journal of Clinical Psychiatry. Although Pollock's letter was not the same as what the PR company drafted, it made nearly every point in the draft — almost in the same sequence. See the PR company's draft letter and Dr. Pollock's letter to the journal. Pollock, who was on the company's advisory board at the time, told " Primetime Live " he wrote the published letter and stands by its accuracy. He did say, however, he " could imagine a scenario where a representative from the makers of Paxil said, 'Could you make this point?' " because it was well-known that he had studied Paxil in elderly patients. But he denied that he had any knowledge of intentions to use his letter in a marketing plan, or that he had any knowledge of the draft letter prepared by the PR firm that included his name. This published letter resurfaced once again in the internal memorandum obtained by " Primetime Live. " The company's 1998 business plan guide for sales reps cited Pollock's letter as " an effective tool for addressing discontinuation. " GlaxoKline declined to comment on these documents, saying " it is difficult to respond to court documents taken out of context. " In court, they have said they provided adequate and complete warnings to physicians about the risks of withdrawal. In a letter to " Primetime Live, " they also said the majority of patients who experience any symptoms have mild to moderate symptoms that are usually self-limiting within two weeks. ABCNEWS' Greg Fisher, Kate Sheekey, Kim Launier and Marc Lallanilla contributed to this report. " Blind Reason " a novel of pharmaceutical intrigue Think your antidepressant is safe? Think again. It's Unsafe At Any Dose Quote Link to comment Share on other sites More sharing options...
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