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Forced treatment: Psychopharmacological Warfare
They say we are crazy. Or "psychotic". Or "schizophrenic". Because our behavior seems strange and unusual, or because we quarreled with our families, or for other reasons. They want us to take horrible mood-altering, brain damaging drugs. They try to subject us to "treatment" like electroconvulsive therapy (ECT). If we refuse, or try to, our resistance is considered a symptom of our illness
All over the world, psychiatric patients treated with neuroleptic drugs say the same thing: the drugs produce suffering you can't imagine if you have never taken them. They cause suffering in body and soul.
Many patients have the terrible feeling that their body does not belong to them anymore. Limbs and face can be subject to involuntary movements. This side effect is called Tardive Dyskinesia. Psychiatrists admit that this happens in 20 % of all cases. In at last 2% of all cases it remains irreversible, even when the patient stops taking the drug.
Most psychiatrists insist that new classes of neuroleptics, developed in recent years, called "atypical" neuroleptics, have far fewer side effects. But these drugs have been in use for only a few years. Nobody can predict their long-term effect.
The effects on the soul can also be terrible. Neuroleptics can make you unable to feel happiness about anything. Some patients say that these drugs "kill their souls".
Some readers would be tempted to ask: "Why are these drugs given, if they produce such unbearable suffering?"
My answer to this question is: these drugs are given because in some situations, they can be useful. They can help when a person has lost his sense of reality, when communication with him has become impossible. And neuroleptics are not too dangerous if taken for, say, three months.
But most psychiatrists insist that neuroleptic drugs should be taken for a lifetime. And in several States in the US, psychiatrists can obtain a court order to force a person to take a drug for years.
neuloeptics
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Columbine revisited
The Columbine High School massacre occurred on April 20, 1999 at Columbine High School in Littleton, Colorado, United States, when two teenage students, Eric Harris (born April 9, 1981) and Dylan Klebold (born September 9, 1981), executed a planned shooting rampage, killing 12 other students and a teacher before committing suicide. Some argue that one of the shooters killed the other and then himself.
[snip]
It's been publicly revealed that Harris had been prescribed and was taking Luvox (Fluvoxamine maleate), a powerful antidepressant, at the time of the shooting spree. Although Klebold's medical records have been sealed, there is strong reason to believe that he too had been prescribed one of several popular drugs for depression. Throughout the 1990s these drugs arguably became the standard response to a wide variety of behavioral problems in schools, especially for boys. An alleged side-effect of these drugs is a loss of empathy for other human beings. Of the various USA "school shooters" whose medical history has been made public, all were either currently taking or had recently gone off one of these powerful mind-altering prescription drugs given to them to treat various serious behavioral problems.
brainy encyclopedia
The Columbine syndrome
back up on indymedia
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A special room under strict lock-and-key, filled with evidence from two settled Columbine cases, is being shut down and a federal magistrate has ordered some of the materials - including depositions of the killers' parents - destroyed.
The room, in the federal courthouse in downtown Denver, was set aside in 2002 to "house particular documents and materials deemed to be worthy of special handling and security," according to court documents.
newsmine
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Jeff Weise: Cointelpro operation?
Columbine - the Sequel?
The Making of monsters out of
corporate-fascist-
state-drugged kids continues:
In an attack eerily similar to the 1999 Columbine massacre,
another student embarked on a school 'rampage' in Minnesota.
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Uzbek human rights activist Elena Urlaeva was detained and forcibly committed to a psychiatric institution for distributing this flyer. The cartoon mocks government corruption, portraying well-known officials suckling from a cow that represents Uzbekistan. - also see here and here
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Uzbekistan: Psychiatric Drugs Used to Punish Activist
(Tashkent, October 21, 2005)-The Uzbek authorities today subjected one of the country's prominent human rights defenders to forcible psychiatric treatment even though Uzbek law prohibits compulsory treatment until the appeals process has expired, Human Rights Watch said today. "Using psychiatric treatment to silence Elena Urlaeva is a gross violation of medical ethics and international standards," said Holly Cartner, Europe and Central Asia director at Human Rights Watch. "It's shocking that the hospital began the treatment without even waiting for the courts to consider her appeal."
Urlaeva told a representative of Human Rights Watch that this morning she was given a dose of Rispolept (also known as Risperidone) by doctors at the Tashkent City Psychiatric Hospital. Rispolept is used to treat schizophrenia. Common side effects include nausea, anxiety, dizziness, insomnia and blurred vision. The medication can have several serious side effects which may be permanent, including tardive dyskinesia, an involuntary and often continuous movement of the tongue and lips, accompanied by grimacing.
Urlaeva reported that she experienced dizziness and shaking after taking the medication, symptoms that are consistent with the drug.
In a visit today with a Western diplomat, Urlaeva was light headed, experienced shaking, and blacked out for several minutes. She was having difficulty with her memory. "I need to hurry to write my legal appeal while I am still functioning," Urlaeva told the diplomat.
Yesterday, the head doctor at the hospital assured a Human Rights Watch representative that Urlaeva would only receive treatment after a period of observation and as her behavior warranted. When Urlaeva asked this morning why she was being medicated, the doctor told her that the clinic has the right to treat her 48 hours after her committal. However, according to Uzbek law, the court's decision ordering committal and compulsory treatment cannot take effect until the appeal period expires on October 28.
Powerful antipsychotic drugs were previously forcibly administered to Urlaeva in 2001 and 2002.
"Elena Urlaeva is being exposed to drugs that have a potential for serious and permanent side effects," said Cartner. "The only reason for this treatment is to punish her and silence her for her human rights work."
The Uzbek authorities detained Urlaeva on 27 August and have kept her in forced psychiatric detention since then. - alertnet.org
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Independent human rights groups estimate that there are more than 600 politically motivated arrests a year in Uzbekistan, and 6,500 political prisoners, some tortured to death. According to a forensic report commissioned by the British embassy, in August two prisoners were even boiled to death. The US condemned this repression for many years. But since September 11 rewrote America's strategic interests in central Asia, the government of President Islam Karimov has become Washington's new best friend in the region. - memory hole
"We all knew basically that if we really wanted to keep access to the base, the way to do it was to shut up about democracy and turn a blind eye to the refugees," said the senior official, on the condition of anonymity because of the sensitive diplomacy. "We could have saved the base if we had wanted." - U.S. Evicted From Air Base In Uzbekistan
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Government connections enable "teen help" industry to thwart regulation.
This sidebar is associated with a full-length feature article, - guerrillanewsAt Some Youth 'Treatment' Facilities, 'Tough Love' Takes Brutal Forms
The controversial world of youth behavior-modification facilities intersects with a web of intricate political connections. And where the treatment industry sees cooperation with government entities, activists warn, these links could cloud the prospects for public oversight of the "teen-help" market.
The influence of the behavior-modification industry is felt on Capitol Hill. Four members of the House of Representatives and one senator serve as honorary board members of Kids Helping Kids, a company with corporate links to a now-defunct behavior-modification program for teen drug users known as Straight Incorporated. The various franchises of that program dissolved in the early 1990s following allegations of child abuse, as well as criticism for using cruel, prisoner-of-war-style brainwashing techniques on adolescents.
Watchdog groups report that Straight Inc. has since morphed into the Drug Free America Foundation, a conservative anti-drug advocacy group. The co-founder, Mel Sembler, is a longtime Republican Party donor and fundraiser who served as ambassador to Italy for the current administration and ambassador to Australia under George H.W. Bush.
The connections are even more direct on the state level. Earlier this year in Montana, a landmark bill to impose regulatory guidelines on adolescent residential treatment facilities was squelched by a powerful lobbying campaign from private service providers. Proposed partially in response to reports of abuse and deaths in some treatment programs, the bill would have authorized the state Department of Health and Human Services to monitor private behavior-modification programs. According to government estimates, Montana contains over two dozen of these institutions, ranging from "wilderness"-based programs to disciplinary boarding academies.
To eclipse the bill, private treatment companies pushed their own legislation, which would effectively place regulatory authority not with the health department but with a five-member board under the Department of Labor. Three of the board's members are representatives of the teen treatment industry, including state Representative Paul Clark, who directs a local therapeutic wilderness program. The bill, which was recently approved by the legislature, requests no public funding and specifically exempts church-affiliated and "faith-based" programs.
According to state records, Spring Creek Lodge, an affiliate of World Wide Association of Specialty Programs and Schools (WWASPS), spent over $50,000 on lobbying activities to help push the bill through the legislature.
In Utah, the WWASPS name is prominently linked to the Republican Party. The Salt Lake City Tribune reported that between 2002 and 2004, WWASPS founder Robert Lichfield, his family, and business associates have contributed a total of more than $1 million to Republican candidates and party organizations - a financial push that coincided with the killing of a 2004 initiative in the state legislature to regulate teen residential treatment facilities.
Charles Huffine, an adolescent psychiatrist who has joined other mental health professionals in urging stronger oversight of residential treatment facilities, is wary of attempts by industry interests to co-opt the regulatory process. "It's the fox-guarding-the-chicken-coop kind of thing," he remarked.
But rather than a conflict of interest, some in the teen help industry see a healthy partnership with officials. In interviews with The NewStandard, WWASPS representatives described a good working relationship between their enterprises and the agencies charged with checking up on them, like state departments of education and, at Tranquility Bay in Jamaica, the United States Embassy.
"I'm all for law enforcement," said WWASPS President Ken Kay. "I think all of our schools work closely with law enforcement and would welcome their visit every day." - guerrillanews
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Antidepressants Double Children's Suicidal Thinking, Study Says
March 6 2006 (Bloomberg) -- Antidepressants appear to double the risk of suicidal thoughts and actions in children who take them, U.S. regulators said in a study outlining the methodology used for a 2004 report that led to warnings on drugs including Eli Lilly & Co.'s Prozac and GlaxoSmithKline Plc's Paxil.
The Food and Drug Administration first presented the findings, detailed today in the Archives of General Psychiatry, to an advisory panel in September 2004. The agency followed the next month with a requirement that makers of antidepressants warn patients and doctors with a notice in prescribing information highlighted with a so-called black box.
The warning led to a 20 percent drop in antidepressant prescriptions for children between March 2004 and June 2005, according to Psychiatric News, the newspaper of the American Psychiatric Association, which cited NDC Health Inc., an Atlanta- based prescription-tracking service. The FDA study examined data from 24 clinical trials of nine antidepressants involving 4,582 children and adolescents. No suicides occurred in the trials.
In addition to Prozac and Paxil, the trials examined Glaxo's Wellbutrin, Pfizer Inc.'s Zoloft, Wyeth's Effexor, Bristol-Myers Squibb Co.'s Serzone, Forest Laboratories Inc.'s Celexa, Akzo Nobel NV's Remeron and Solvay SA's Luvox.
The analysis of findings from all the studies found that, overall, about 4 percent of children taking the drugs thought about or attempted suicide, compared with 2 percent of those taking a placebo. The degree of risk varied from trial to trial.
The FDA announced last July that it was assessing whether antidepressants also increase the risk of suicidal thinking or actions among adults. The agency plans to release data from that review about midyear, said Thomas Laughren, director of the division of neuropharmacological drug products.
- bloomberg
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Experts Defining Mental Disorders Are Linked to Drug Firms
By Shankar Vedantam - Washington Post Staff Writer - Thursday, April 20, 2006; washingtonpost.com
Every psychiatric expert involved in writing the standard diagnostic criteria for disorders such as depression and schizophrenia has had financial ties to drug companies that sell medications for those illnesses, a new analysis has found.
Of the 170 experts in all who contributed to the manual that defines disorders from personality problems to drug addiction, more than half had such ties, including 100 percent of the experts who served on work groups on mood disorders and psychotic disorders. The analysis did not reveal the extent of their relationships with industry or whether those ties preceded or followed their work on the manual.
"I don't think the public is aware of how egregious the financial ties are in the field of psychiatry," said Lisa Cosgrove, a clinical psychologist at the University of Massachusetts in Boston, who is publishing her analysis today in the peer-reviewed journal Psychotherapy and Psychosomatics.
The analysis comes at a time of growing debate over the rising use of medication as the primary or sole treatment for many psychiatric disorders, a trend driven in part by definitions of mental disorders in the psychiatric manual.
Cosgrove said she began her research after discovering that five of six panel members studying whether certain premenstrual problems are a psychiatric disorder had ties to Eli Lilly & Co., which was seeking to market its drug Prozac to treat those symptoms. The process of defining such disorders is far from scientific, Cosgrove added: "You would be dismayed at how political the process can be."
The American Psychiatric Association, which publishes the guidelines in its bible of disorders, the Diagnostic and Statistical Manual (DSM), said it is planning to require disclosure of the financial ties of experts who write the next edition of the manual -- due around 2011. The manual carries vast influence over the practice of psychiatry in the United States and around the world.
Darrel Regier, director of the association's division of research, said that concerns over disclosure are a relatively recent phenomenon, which may be why the last edition, published in 1994, did not note them. Regier and John Kane, an expert on schizophrenia who worked on the last edition, agreed with the need for transparency but said financial ties with industry should not undermine public confidence in the conclusions of its experts. Kane has been a consultant to drug companies including Abbott Laboratories, Eli Lilly, Janssen and Pfizer Inc.
"It shouldn't be assumed there is a true conflict of interest," said Kane, who said his panel's conclusions were driven only by science. "To me, a conflict of interest implies that someone's judgment is going to be influenced by this relationship, and that is not necessarily the case. . . ."
The DSM defines disorders in terms of constellations of symptoms. While neuroscience and genetics are revealing biological aspects to many disorders, there has been unease that psychiatry is ignoring social, psychological and cultural factors in its pursuit of biological explanations and treatments.
"As a profession, we have allowed the biopsychosocial model to become the bio-bio-bio model," Steven Sharfstein, president of the American Psychiatric Association, said in an essay last year to his colleagues. He later added, "If we are seen as mere pill pushers and employees of the pharmaceutical industry, our credibility as a profession is compromised."
He stressed that the association has strict guidelines to police the role of the pharmaceutical industry but said the profession as a whole needs to do a better job monitoring ethical conflicts.
Sharfstein added yesterday that the presence of experts with ties to companies on the manual's expert panels is understandable, given that many of the top experts in the field are involved in drug research.
"I am not surprised that the key people who participate have these kinds of relationships," he said. "They are the major researchers in the field, and are very much on the cutting edge, and will have some kind of relationship -- but there should be full disclosure."
At least one psychiatrist who worked on the current manual criticized the analysis. Nancy Andreasen of the University of Iowa, who headed the schizophrenia team, called the new analysis "very flawed" because it did not distinguish researchers who had ties to industry while serving on the panel from those who formed such ties afterward.
Two out of five researchers on her team had had substantial ties to industry, she said. Andreasen said she would have to check her tax statements to know whether she received money from companies at the time she worked on the panel, but said, "What I do know is that I do almost nothing with drug companies. . . . My area of research is neuroimaging, not psychopharmacology."
The analysis could not determine the extent or timing of the financial ties because it relied on disclosures in journal publications and other venues that do not mention many details, said Sheldon Krimsky, a science policy specialist at Tufts University who also was an author of the new study. Whether the researchers received money before, during or after their service on the panel did not remove the ethical concern, he said.
Krimsky, the author of the book "Science in the Private Interest," added that although more transparency is welcome, the psychiatric association should staff its panels with disinterested experts.
"When someone is establishing a clinical guideline for the bible of psychiatric diagnosis, I would argue they should have no affiliation with the drug companies in those areas where the companies could benefit from those decisions," he said.
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Tots Used as Human Guinea Pigs?
May 12, 2006 10:56 AM Joseph Rhee Reports: ABC
ABC News has learned that a Massachusetts hospital is currently recruiting pre-schoolers to test the safety and effectiveness of a powerful antipsychotic drug called Quetiapine.
The study, conducted by the Department of Pediatric Psychopharmacology at Massachusetts General Hospital, is testing subjects from four to six years of age with Bipolar Disorder. An earlier Massachusetts General study of the antipsychotic drugs Risperidone and Olanzapine recruited children as young as three years old.
These antipsychotic drugs are only approved for use by adults and are so toxic they carry a "black box warning." The drugs have been found to cause diabetes; a life-threatening nervous system problem called Neuroleptic Malignant Syndrome; low blood pressure; and have also led to higher death rates in the elderly. Despite these serious potential side-effects, a patient recruitment video obtained by ABC News contains no mention of any of these risks.
Vera Hassner Sharav of the Alliance for Human Research Protection said, "Antipsychotics were never approved for use in children whose developing brains and central nervous system may be irreversibly harmed. We believe that physicians who subject children to the toxic effects of these drugs...are practicing outside medically accepted standards."
A previous clinical trial of Olanzapine was conducted by UCLA in 1998 on five children, aged 6 to 11. The authors of the study said treatment was discontinued within the first six weeks "because of adverse effects or lack of clinically significant therapeutic response."
Sharav also said it's questionable whether or not three or four year-olds can be accurately diagnosed for Bipolar Disorder. According to a 1999 Surgeon General report, "The signs and symptoms of mental disorders are often also the characteristics of normal development." The National Institute for Mental Health has concluded that "diagnostic uncertainty...surrounds most manifestations of psychopathology at such an early age."
Neither the hospital nor the lead investigator for the trials, Dr. Joseph Biederman, responded to our requests for a comment on the trials.
Click here for information on the Massachusetts General clinical trial.
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GlaxoSmithKline Reverses Decade of Denial:
in Clinical Trials Paxil Triggered Significantly More Suicide Attempts in Adults than Placebo
Friday, 12 May 2006 - source
A faith-based belief system masquerading as science is collapsing under the weight of evidence that has, for so long been denied by drug manufacturers, by the FDA, and by psychiatry.:the best selling, most profitable antidepressants pose an increased risk of suicide for children and adolescents, for “young adults”—in fact, no age group is exempt. [1]
1. GlaxoSmithKline (GSK) has submitted documents to the FDA and other regulatory agencies, contradicting its decade long denial that its antidepressant drug, paroxetine (Paxil / Seroxat) increased the risk of suicidal behavior in the company’s controlled clinical trials,. http://www.gsk.com/media/paroxetine_adult.htm
2. In a letter to healthcare professionals this week, GSK warned about the increased suicide risk stating:
"There is a possibility of an increased risk of suicide related behavior in young adults ages 18-29" -- whether the drug is prescribed for depression or for other conditions not associated with suicide. http://www.gsk.com/media/paroxetine/adult_hcp_letter.pdf
3.GSK is the first of the SSRI drug manufacturers to acknowledge in the Paxil label that the drug may trigger more than “suicidal thoughts.” The drug increases the risk of “suicide attempts.” The Paxil CR label now includes the following warning:
“young adults, are at an increased risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.”
GSK added warnings acknowledging that patients on the drug may experience “persistently worse” depression, or may “experience emergent suicidality or symptoms that might be precursors to worsening depression or suicidality” and “these symptoms” may be “severe, abrupt in onset, or were not part of the patient’s presenting symptoms."
The company advises doctors: “"Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication.”
When was the link between SSRI antidepressants to suicide first reported?
In 1990 by Dr. Martin Teicher warned that Prozac (the first SSRI antidepressant) could cause suicidal behavior: “At the present time we recommend that this drug be used cautiously and that the practitioner be attentive to the possible emergence of suicidal ideation, even in those patients without a previous history of suicidal thoughts or actions.” [2]
In 1991 Dr. Robert King reported that the same phenomenon happens in children. [3] Yet, for more than a decade, drug companies indignantly denied any suggestion of such a risk, attacking those who were able to see the risk and dare to disagree.
In 1991, the FDA convened an advisory committee whose financial ties to Eli Lilly, allowed them to equivocate enough for the FDA to conclude “there is no credible evidence” that Prozac increases the risk of suicide… This imprimatur became the watchword of the industry and the new antidepressants skyrocketed to a $17 billion dollar market.
But the human casualties who had been prescribed Paxil and other SSRIs mounted, and in October, 2002, the BBC-Panorama aired an investigative report whose after-effects still reverberate on both sides of the Atlantic, as well as in Australia. BBC not only introduced the public to victims of irresponsible prescribing of the drug, and GSK’s drug marketing tactics, making visible the collision between patients' physical and mental well-being and corporate marketing tactics, but the program laid bare the indifference of regulatory agency officials to a serious threat to public health safety.
In May, 2003, a BBC follow-up report provided the opportunity for two expert psychiatrists to express their opposing views publicly. Dr. David Healy, psychopharmacologist, medical historian, and Director, North Wales Department of Psychological Medicine, cited evidence of a suicide risk, and Dr. Alastair Benbow, GSK’s Head of European Psychiatry, defended the drug and denied the risk. [4]
Dr. Healy: “The evidence is that roughly one person in sixty that goes on this drug makes a suicide attempt. Now you have to contrast that with the people going on placebo or sugar pill, and the rate there is one person in five hundred and fifty. That's nine or ten times less. The risk on the drug is nine or ten times greater than the risk on sugar pill.”
Dr. Benbow: “We have been asked by the regulatory authorities to provide all our information related to suicides and I can tell you the data that we provide to them clearly shows no link between Seroxat and an increased risk of suicide – no link.”
BBC reporter asked Dr. Benbow if he was “absolutely confident” that Dr. Healy is wrong on this issue and will be shown to be wrong?”
Dr. Benbow replied:
“Yes, absolutely. Not only that but Doctor Healy has made the same claims about a range of other medicines. He made the same claims about Prozac… [repeats]…he made the same claims about a range of other SSRIs. On every occasion he has been found to be wrong.”
In September, 2004, Alan Metz, GSK North American medical director told the Wall Street Journal: “Each time it has been looked at, there is no suggestion of an association with suicidal tendencies in adults, with relation to SSRIs.”
For more than a decade, they claimed that depression causes suicide, not the drugs. Since then, the backtracking of the naysayers has taken on an almost comedic air. In 2004, they acknowledged "suicidality" in kids, but not suicide, and certainly not adults. Now, GSK admits the drug is associated with increased risk of suicide attempts in adults, but only in young adults. Well, okay, the fine print states “the higher frequency observed in the younger adult population may extend beyond the age of 24.” But “it is difficult to conclude a causal relationship.”
No it’s not difficult to conclude a causal relationship. This double speak is reminiscent of comedian Steve Martin’s admission to smoking marijuana:
"I used to smoke marijuana. But I'll tell you something: I would only smoke it in the late evening..... Oh, occasionally the early evening, but usually the late evening - or the mid-evening...... Just the early evening, midevening and late evening. Occasionally, early afternoon, early midafternoon, or perhaps the late-midafternoon. Oh, sometimes the early-mid-late-early morning. . . . But never at dusk.."
This week's GSK acknowledgements put to rest the hackneyed defenses:
“it’s the disease not the drug” and “no evidence of a drug-induced suicide risk in adults.”
The simple truth is this: these drugs can cause violent suicidal behavior and death: in kids and in adults, in depressed people and in nondepressed people. The data do not demonstrate that any segment of the population is not susceptible to this risk.
Industry’s denials were buttressed by the FDA.
Daniel Troy, FDA’s former chief counsel, intervened in judicial procedures on behalf of drug companies by invoking FDA authority which he falsely claimed pre-empts state laws protecting public health safety. In a 2002 Amicus Curiae brief, Troy wrote: “…had Pfizer given a warning as to a causal relation between Zoloft and suicide, FDA would have disapproved the warning. Indeed, based on its current scientific knowledge, FDA would still do so today.” [5]
Then, senior FDA officials tried to suppress a report by FDA’s own safety officer, Dr. Andrew Mosholder, whose pediatric SSRI data analysis confirmed a twofold suicidal risk. [6]
Only under intense pressure (in 2004) from parents whose children became suicidal after an SSRI was prescribed; and only after Congress applied pressure on the FDA were warnings of suicidality added to these drugs’ label. However, complaints by drug companies led the FDA to weaken the warnings, removing the following sentence from the label: “A causal role for antidepressants in inducing suicidality has been established in paediatric patients.”
Even as black box warnings were being crafted senior FDA officials denied the existence of evidence the drugs increase the risk of suicide. Dr. Robert Temple testified before a Congressional committee: “At the time ... it was not an issue that was prominent in our thinking," Temple testified. "We had never seen a signal for suicidality in the adult data." [7] And Dr. Thomas Laughren said his agency had a database of about 40,000 adult patients involved in clinical trials and that "so far, we have seen no signal" indicating the drugs might increase suicide risk.”
GSK’s public admission that in fact, in some cases, young adults (18-24) who take Paxil (paroxetine) are at increased risk of suicide, is based on clinical trial data that GSK and the FDA have been sitting on since the early 1990’s. This acknowledgement of the evidence contradicts its repeated pronouncements and contradicts the sworn congressional testimony of these FDA officials.
Despite the acknowledged suicide risk, GSK attempts to persuade physicians (in the letter to healthcare professionals) to continue to prescribe their drug, offering the company's faith-based "belief" in the drug's benefit: "GSK continues to believe that the overall risk-benefit of paroxetine in the treatment of patients with MDD and other non-depressive disorders remains positive…"
http://www.gsk.com/media/paroxetine/adult_hcp_letter.pdf
But here again, the evidence does not support GSK’s claim of SSRI drug efficacy. A meta-analysis of the clinical trial evidence from short and long-term clinical trials by Professor Irving Kirsch and colleagues, showed that 83% of the effect of these drugs is duplicated by placebo. [8]
The question is: Should drugs be approved and marketed on the basis of what the drug company believes, or what the evidence shows?
The pharmaceutical industry is regulated because drugs have the potential to cause serious harm, and industry, with its obvious financial conflict of interest cannot be relied upon to serve the public interest. This is the reason we have an FDA—its mission is to protect us from harmful drugs that companies may want to market. How has this regulatory system been working?
For 15 years the FDA has stood firm in support of drug companies even as they misinformed physicians and the public with false assurances about the safety of these drugs, claiming that there is no evidence of a drug-related risk of suicide. FDA’s policy allowed drug companies to market SSRI’s aggressively by flooding the media with deceptive advertisements. The drugs became blockbusters and companies raked in billions of dollars in sales. All the while, both the industry and the FDA covered their eyes and ears to the human tragedies and the rising number of drug-related casualties.
GSK now reluctantly acknowledges the evidence linking the risk of suicide to its antidepressant, evidence whose existence GSK had denied for so long. That evidence is not new. Dr. Teicher, Dr. King, and all the physicians and lay people who recognized the red flags about these drugs’ hazards, and were courageous enough to speak out, were right all along. And the FDA was wrong all along. Even today, the FDA has not acknowledged the lethal risk that GSK has finally admitted. The evidence has been in FDA’s files for years. Thus, its failure to warn to protect the lives of children and adults is either due to their incompetence or their complicity with drug manufacturers. Either way, their inaction is a dismal failure and betrayal of the public trust.
Earlier this month, the GAO issued a report about its investigation of the FDA, concluding that the FDA is broken and unable to fix itself. [9] The GAO suggested that new legislation is needed to correct the corruption at the current FDA that today is costing people their lives. This latest installment in the book of FDA failures confirms the GAO report. The only question now is whether congress cares more about public health or the financial interests of the pharmaceutical industry.
References:
1. Juurlink, DN, Mamdani, MM, Kopp, A, Redelmeier, DA. The Risk of Suicide With Selective Serotonin Reuptake Inhibitors in the Elderly, The American Journal of Psychiatry (May 2006).
2. Teicher, M. H., Glod C., & Cole J. O. (1990). Emergence of intense suicidal preoccupation during fluoxetine treatment. American Journal of Psychiatry, 147, 207–210. See also case report by Creaney, W, Murray, I, and Healy, D. Antidepressant Induced Suicidal Ideation, Human Psychopharmacology, 1991, Vol. 6:329-332.
3. King, R. A., Riddle, M. A., Chappell, P. B., Hardin, M. T., Anderson, G. M., & Lombroso, P. (1991). Emergence of self-destructive phenomena in children and adolescents during fluoxetine treatment. Journal of the American Academy of Child and Adolescent Psychiatry, 30, 171–176.
4. BBC Panorama: Postcards from the Edge, 5/11/03
5. Daniel E. Troy, Chief Counsel Food and Drug Administration Amicus Brief, September 3, 2002 ; See also: Gary Young, FDA legal strategy would pre-empt tort suits National Law Journal March, 2004, vol. 128; Pg. 3 www.law.com/jsp/nlj/PubArticleNLJ.jsp?id=1076428430132
See also, http://www.ahrp.org/infomail/05/09/30.php
6. Dr. Mosholder's embargoed report and the accompanying FDA memos are posted on the AHRP website at: http://www.ahrp.org/risks/SSRImosholder/index.php
7. Anne C. Mulkern, Panel hammers FDA on antidepressant issue Kids' suicide risk cited, Denver Post, September 24, 2004.
8.Irving Kirsch, Alan Scoboria, Thomas J. Moore, Antidepressants and Placebos: Secrets, Revelations, and Unanswered Questions, Prevention & Treatment, Volume 5, Article 33, posted July 15, 2002 http://journals.apa.org/prevention/volume5/pre0050033r.html
9. GAO Report http://www.ahrp.org/cms/content/view/148/28/
Contact: Vera Hassner Sharav
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Improper sales of medicines targeted:
Drug firms have paid fines of $3.5 billion since 2001 for wrongful promotions
By Jonathan D. Rockoff - May 7, 2006 - THE BALTIMORE SUN WASHINGTON --
A Civil War-era law designed to root out fraudulent Army contracts has been quietly employed by whistleblowers and federal prosecutors in recent years as a powerful tool for cracking down on pharmaceutical companies wrongly promoting their drugs.
Companies prosecuted under the federal False Claims Act have paid nearly $3.5 billion in penalties since 2001 for giving doctors televisions, selling them drugs at undisclosed discounts and taking other improper steps to encourage sales.
Such intensive drug marketing campaigns have led doctors to give patients drugs they don't need, sometimes with dangerous results, according to
watchdog groups and academics.
Industry lawyers and consultants say the risk of hefty fines has become as potent as the threat of congressional action in prompting pharmaceutical
companies to reform their sales practices, especially after studies linking painkillers and anti-depressants to deaths and suicides.
To avoid prosecution under the act, drug companies are hiring compliance officers, re-training sales staff and creating hot lines so employees can
alert them of wrongdoing. Concern is so heightened, said one lawyer, that companies interested in acquiring competitors first investigate employee
firings and grievances that could result in a whistleblower's filing a false claim complaint.
"There's no facet of pharmaceutical company activities that has not been affected," said William A. Sarraille, another lawyer representing drug
manufacturers, who has defended six cases.
Federal law permits companies to promote drugs only for uses approved by the Food and Drug Administration. For decades, that agency, almost exclusively, policed advertising. When it found "off-label" -- not FDA-approved -- promotions or misleading marketing, it sent a warning letter. Occasionally, companies signed a consent degree, but they did not face fines.
Then in 1991 prosecutors began looking into claims that Genentech had marketed the growth hormone Protropin by suggesting that doctors prescribe it to healthy children who did not suffer from a hormone deficiency, an unapproved use. While doctors and patients are free to depart from FDA guidelines for drug use, companies cannot promote off-label prescriptions.
Prosecutors alleged improper marketing under the False Claims Act --- an obscure federal law that had been on the books for more than 100 years --and Genentech paid $50 million in 1999 to settle the case.
Lincoln backed law
The False Claims Act, passed in 1863 with the strong support of President Abraham Lincoln, was enacted to prevent arms manufacturers from sending to the Union Army crates stuffed with sawdust instead of guns. The act was strengthened in 1986, after criticism that the Pentagon had paid exorbitant prices for toilet seats and hammers.
Until Genentech, the law had been applied only to military procurement. But federal prosecutors realized that they could use it also for pharmaceutical companies that marketed drugs to patients for unapproved purposes and had been reimbursed for the medicine by a federal program, such as Medicare and Medicaid.
"Health care spending was high. There was concern about fraud and abuse issues. Pricing was becoming more complex," said Wayne Pines, a former FDA associate commissioner who now consults for the pharmaceutical industry and who is writing a book about false claims prosecutions. "All those were the variables that led to the enforcement."
Since the Genentech case, prosecutors have used the law in 15 cases involving such major companies as AstraZeneca, Bayer, GlaxoSmithKline,
Schering-Plough and Pfizer. Those cases were settled, and another 150 are pending, according to Taxpayers Against Fraud, a nonprofit group that
assists whistleblowers and tracks False Claims Act litigation.
One reason the law has been effective is its reward to tipsters, who can receive 15 percent to 30 percent of the penalties against a company. A
formal complaint is typically kept under seal while prosecutors decide whether to take the case. The litigation sometimes includes criminal charges
under other federal laws. It usually takes 38 months for a case to go from complaint to settlement, according to Taxpayers Against Fraud, and the
average award to whistleblowers is $120,000.
A Baltimore woman, Sandra Boucher, was among several whistleblowers who tipped off prosecutors in what turned out to be one of the largest
settlements. Last year, Serono Laboratories of Rockland, Mass., agreed to pay $704 million to resolve charges that it had illegally marketed the drug Serostim to patients who didn't need it. Boucher, who was a sales representative, declined through her lawyer to comment.
At $21,000 for a course of medication, Serostim aimed to reverse the profound weight loss often experienced by AIDS patients. But the development of other treatments soon limited the AIDS wasting. Prosecutors said Serono tried to spur sales anyway, offering doctors free trips to a medical conference in Cannes, France, in exchange for writing more prescriptions for the drug. The company also allegedly gave doctors a device designed to show patients were losing body mass and needed the drug, though the FDA never approved use of the device for that purpose. From 1997 to 2004, prosecutors said, Medicaid paid more than $600 million in claims for Serostim.
Incentives
Given the potential for such large sums from federal programs, attempts to cheat the government are inevitable, lawyers for whistleblowers say. But
without the financial incentives for whistleblowers, they say, the government would be unlikely to unearth such fraud. "A regulator sitting in an office in Washington isn't going to know that a sales rep sitting in a doctor's office is going to offer a trip to Cannes," said J. Stephen Simms, a Baltimore lawyer who represented Boucher. Simms said he has 50 whistleblower cases under seal.
Lawyers who represent drug companies say oversight is better left to the FDA because it understands the industry and the practice of medicine. And prosecutors' legal premise -- that marketing a drug for off-label use can defraud the government -- might not even stand up in court, the lawyers add, although drug companies have chosen to settle cases rather than risk losing lucrative government reimbursement for their drugs.
"Everyone wants to kick around [pharmaceutical companies] these days, and you don't really want to go through a trial about your marketing activities, even if you think they are appropriate," added John Kamp, executive director of the Coalition for Healthcare Communication, a group of trade associations.
Prosecutors, Kamp says, have unfairly criminalized activities that federal drug regulators and courts had permitted. Doctors often prescribe drugs
off-label, and if the physicians inquire about such uses, manufacturers can legally provide copies of journal articles and other information. But Kamp
says some prosecutors have used such information exchanges against companies.
The industry has asked the Department of Justice to reconsider the prosecution tactics, Kamp says. Meanwhile, conservatives have reportedly
lobbied Congress to cut whistleblower awards. The Washington Legal Foundation, a pro-business group, has also stepped in, filing briefs in a
few false claims cases defending drug manufacturers and seeking to reduce whistleblower awards. It has also urged the Justice Department to involve the FDA more in deciding when to prosecute.
"The FDA, in general, gets it," said Richard Samp, the foundation's chief counsel. "But the FDA is very much out of the loop in many of these criminal prosecutions."
Patrick L. Meehan, a U.S. attorney in Pennsylvania, says whether or not the FDA condoned the practices, the companies broke the law. "If that's the way things work, then it's wrong," he said.
As a condition of the settlements, prosecutors require drug companies to institute programs to prevent further improper marketing. When it agreed in 2001 to pay $875 million to settle charges -- the largest penalty so far --TAP Pharmaceutical Products also pledged to reform its promotional
practices.
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