Happy Early Halloween from Fiddy.
Awesome video please check it out.
October 21, 2009 • 12:53 am 1
Happy Early Halloween from Fiddy.
Awesome video please check it out.
March 20, 2009 • 11:58 pm 0
Yes, this is the same guy who earlier stated that he was ranked right below God. Things that make you go, “hmmmmmmm.”
Court documents are coming to light that suggest Harvard psychiatrist Joseph Biederman told Johnson & Johnson, before certain trials of its drugs were started, that he expected positive results.
Biederman is one of a number of prominent doctors targeted by Sen. Chuck Grassley’s investigation into conflicts of interest among doctors. Late last year, he agreed to stop working on clinical trials sponsored by industry until completion of a probe of his alleged lack of disclosure of more than $1.6 million in payments he received from companies including J&J and Eli Lilly, both makers of prominent psychiatric drugs.
According to court documents, Biederman made a presentation to J&J execs in which he displayed a slide that referred to a proposed study of the company’s antipsychotic Risperdal, known generically as risperidone, in preschool children, the New York Times reports. The trial “will support the safety and effectiveness of risperidone in this age group,” as NYT quotes the slide.
Another slide discussed a trial that would compare Risperdal with competitors in managing pediatric bipolar disorder. The trial “will clarify the competitive advantages of risperidone vs. other neuroleptics,” as NYT quotes it the documents.
Biederman’s attorneys are trying to get a judge to seal his testimony and accompanying documents in a multistate suit in which he is a key witness, saying they “could be immensely damaging to him, both personally and professionally,” the Boston Globe reports. The suit involves more than 2,000 patients, including children, who say they have been injured by drugs known as atypical antipsychotics. Growing use of psychiatric drugs in children has been a center of controversy in the past couple of years.
Biederman didn’t comment in the NYT or Globe stories, but he has written before that J&J’s financial support for a research center with which he was involved didn’t interfere with the center’s research findings. J&J has also said funding it provided the center “followed strict guidelines to ensure scientific independence and did not direct the content or conclusions of the research.”
December 7, 2008 • 3:39 pm 0
November 25, 2008
The New York Times
Research Center Tied to Drug Company
By GARDINER HARRIS
When a Congressional investigation revealed in June that Dr. Joseph Biederman, a world-renowned child psychiatrist, had earned far more money from drug makers than he had reported to his university, he said that his interests were “solely in the advancement of medical treatment through rigorous and objective study.”
But e-mail messages and internal documents from Johnson & Johnson made public in a court filing reveal that Dr. Biederman pushed the company to finance a research center at Massachusetts General Hospital, in Boston, with a goal to “move forward the commercial goals of J.& J.” The documents also show that the company prepared a draft summary of a study that Dr. Biederman, of Harvard, was said to have written.
Dr. Biederman’s work helped to fuel a fortyfold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful, risky and expensive antipsychotic medicines in children.
Although many of his studies are small and often financed by drug makers, Dr. Biederman has had a vast influence on the field largely because of his position at one of the most prestigious medical institutions.
Massachusetts General said in a statement Monday that it took the accusations related to the research center “very seriously” and intended “to investigate these issues thoroughly.”
Johnson & Johnson makes a popular antipsychotic medicine called Risperdal, or risperidone. More than a quarter of its use is in children and adolescents.
Last week, a panel of federal drug experts said that medicines like Risperdal were being used too cavalierly in children and that regulators must do more to warn doctors of their substantial risks. Other popular antipsychotic medicines, also referred to as neuroleptics, are Zyprexa, made by Eli Lilly; Seroquel, made by AstraZeneca; Geodon, made by Pfizer; and Abilify, made by Bristol-Myers Squibb.
Thousands of parents have sued AstraZeneca, Eli Lilly and Johnson & Johnson, claiming that their children were injured after taking the medicines; they also claim that the companies minimized the risks of the drugs.
As part of the lawsuits, plaintiffs’ lawyers have demanded millions of documents from the companies. Nearly all have been provided under judicial seals, but a select few that mentioned Dr. Biederman became public after plaintiffs’ lawyers sought a judge’s order to require Dr. Biederman to be interviewed by them under oath.
In a motion filed two weeks ago, lawyers for the families argued that they should be allowed to interview Dr. Biederman under oath because his work had been crucial to the widespread acceptance of pediatric uses of antipsychotic medicines. To support this contention, the lawyers included more than two dozen documents, among them e-mail messages from Johnson & Johnson that mentioned Dr. Biederman. A judge has yet to rule on the request.
The documents offer an unusual glimpse into the delicate relationship that drug makers have with influential doctors.
In a November 1999 e-mail message, John Bruins, a Johnson & Johnson marketing executive, begs his supervisors to approve a $3,000 check to Dr. Biederman as payment for a lecture he gave at the University of Connecticut.
“Dr. Biederman is not someone to jerk around,” Mr. Bruins wrote. “He is a very proud national figure in child psych and has a very short fuse.”
Mr. Bruins wrote that Dr. Biederman was furious after Johnson & Johnson rejected a request that Dr. Biederman had made for a $280,000 research grant. “I have never seen someone so angry,” Mr. Bruins wrote. “Since that time, our business became non-existant (sic) within his area of control.”
Mr. Bruins concluded that unless Dr. Biederman received a check soon, “I am truly afraid of the consequences.”
A series of documents described the goals behind establishing the Johnson & Johnson Center for the study of pediatric psychopathology, where Dr. Biederman serves as chief.
A 2002 annual report for the center said its research must satisfy three criteria: improve psychiatric care for children, have high standards and “move forward the commercial goals of J.& J.,” court documents said.
“We strongly believe,” the report stated, “that the center’s systematic scientific inquiry will enhance the clinical and research foundation of child psychiatry and lead to the safer, more appropriate and more widespread use of medications in children.
“Without such data, many clinicians question the wisdom of aggressively treating children with medications, especially those like neuroleptics, which expose children to potentially serious adverse events.”
A February 2002 e-mail message from Georges Gharabawi, a Johnson & Johnson executive, said Dr. Biederman approached the company “multiple times to propose the creation” of the center. “The rationale of this center,” the message stated, “is to generate and disseminate data supporting the use of risperidone in” children and adolescents.
Documents show that Johnson & Johnson gave the center $700,000 in 2002 alone. Massachusetts General said in its statement on Monday that grant agreements indicated the center “was for scientific and educational purposes only and not for purposes of promoting, directly or indirectly, the products of Johnson & Johnson and its affiliates.”
A statement Monday from Janssen Pharmaceutica, a unit of Johnson & Johnson, said it helped finance the research center in 2002 “with an objective to conduct rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children.”
A June 2002 e-mail message to Dr. Biederman from Dr. Gahan Pandina, a Johnson & Johnson executive, included a brief abstract of a study of Risperdal in children with disruptive behavior disorder. The message said the study was intended to be presented at the 2002 annual meeting of the American Academy of Child and Adolescent Psychiatry.
“We have generated a review abstract,” Dr. Pandina wrote, “but I must review this longer abstract before passing this along.”
One problem with the study, Dr. Pandina wrote, is that the children given placebos and those given Risperdal both improved significantly. “So, if you could,” Dr. Pandina added, “please give some thought to how to handle this issue if it occurs.”
The draft abstract that Dr. Pandina put in the e-mail message, however, stated that only the children given Risperdal improved, while those given placebos did not. Dr. Pandina asked Dr. Biederman to sign a form listing himself as the author so the company could present the study to the conference, according to the message.
“I will review this morning,” responded Dr. Biederman, according to the documents. “I will be happy to sign the forms if you could kindly send them to me.” The documents do not make clear whether he approved the final summary of the brief abstract in similar form or asked to read the longer report on the study.
Drug makers have long hired professional writers to compose scientific papers and then recruited well-known doctors to list themselves as the author. The practice, known as ghostwriting, has come under intense criticism recently, and medical societies, schools and journals have condemned it.
In June, a Congressional investigation revealed that Dr. Biederman had failed to report to Harvard at least $1.4 million in outside income from Johnson & Johnson and other makers of antipsychotic medicines.
In one example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked by Senator Charles E. Grassley, an Iowa Republican who is leading the Congressional inquiry, to check again, Dr. Biederman said he had received $3,500. But Johnson & Johnson told Mr. Grassley that it paid $58,169 to Dr. Biederman in 2001.
A Harvard spokesman, David J. Cameron, said Monday that the university was still reviewing Mr. Grassley’s accusations against Dr. Biederman. Mr. Cameron added that the university had not seen the drug company documents in question and that it was not directly involved in the child psychiatry center at Massachusetts General.
Calls to Dr. Biederman were not returned.
November 25, 2008 • 11:42 am 1
Johnson & Johnson spent at least $700,000 to fund the Johnson & Johnson Center for Pediatric Psychopathology at Massachusetts General Hospital. The purpose of the center, according to an internal company e-mail contained in the court documents, was to “generate and disseminate data supporting the use” of Risperdal in children and adolescents.
Risperdal is used to treat bipolar disorder and schizophrenia.
The e-mails were from 2001 and 2002, long before the U.S. Food and Drug Administration approved Risperdal for use in children in 2006. Physicians are allowed to prescribe drugs for unapproved uses or patients, but drugmakers are barred from marketing drugs for such off-label uses and can face civil charges and steep fines.
Officials at Ortho-McNeil-Janssen Pharmaceuticals Inc., the Johnson & Johnson subsidiary in Titusville, N.J., that makes Risperdal, said they funded the center “to conduct rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children.”
The company said it promoted its products “only for their FDA-approved indications.”
Biederman did not return a phone call.
The documents were provided by plaintiff lawyers pursuing a class-action suit against Johnson & Johnson, contending that such a powerful drug should not have been widely recommended for children.
The court papers show Johnson & Johnson:
Budgeted $6.4 million to hold “educational summits” and sponsor advisory panels in part to counter negative media reports on the research, diagnosis and treatment of children with mental illness;
Was actively involved in drafting research that Biederman was to present at a medical conference and asked him how to deal with unfavorable research results suggesting that a placebo worked as well as Risperdal;
Discussed clinical trials for drugs as “growth opportunities” and tied trial proposals to sales potential.
Biederman is a Harvard researcher and psychiatrist whose work has fueled a rapid rise in diagnoses of bipolar disorder in children. His studies, often on small numbers of children and funded by drug companies, have expanded the use of what are known as atypical antipsychotics in children.
Children are believed to be much more vulnerable to the side effects of these drugs, which include weight gain, breast milk production in both sexes, facial tics and muscle tremors.
Last Tuesday, a panel of federal drug experts said antipsychotic medicines were overused in children and urged the Food and Drug Administration to do more to warn doctors of their risks.
Besides Risperdal, atypical antipsychotics include Zyprexa, made by Eli Lilly & Co.; Seroquel, made by AstraZeneca P.L.C. and others.
The documents, which resulted from discovery efforts in the lawsuits, portray Biederman as using his influence to get money out of Johnson & Johnson.
In an e-mail from November 1999, for example, Johnson & Johnson marketing executive John Bruins warned his bosses to quickly issue a $3,000 check to Biederman to pay for a lecture.
“Dr. Biederman is not someone to jerk around,” Bruins wrote. “He is a very proud national figure in child psych and has a very short fuse.”
Bruins also suggested that Biederman had taken business away from Johnson & Johnson after the company turned down the doctor’s request for a $280,000 research grant. “I have never seen someone so angry,” Bruins wrote. “Since that time, our business became non-existant (sic) within his area of control.”
In the court documents, e-mails from Johnson & Johnson executives said Biederman had asked the company to fund a pediatric research institute at Massachusetts General Hospital, resulting in a donation of at least $700,000 in 2002. Biederman is listed as the chief of the Johnson & Johnson Center for Pediatric Psychopathology.
Biederman is the subject of investigations by Harvard and by Sen. Charles Grassley (R., Iowa) for failing to disclose to Harvard at least $1.4 million in funds from Johnson & Johnson and other companies. Laws require researchers to disclose such relationships to their employers, to protect the integrity of medical research.
Massachusetts General said yesterday in a statement that it planned to investigate the allegations raised in the court documents.
Harvard said it was not connected to Massachusetts General Hospital or to the pediatric institute there. A university spokesman said he could not comment on Harvard’s review.
Biederman first told Grassley he had received $3,500 from Johnson & Johnson, but the company told the senator’s office the figure was $58,169 in 2001.
November 18, 2008 • 7:19 pm 0
To gain approval for treating children, all a drug company has to do is submit two positive studies to the FDA to prove a medication is safe and effective for kids. However, after 20 years of feeding the new generation of antidepressants to tens of thousands of kids in clinical trials, the only one ever approved is Prozac.
Collectively, these antidepressants are referred to as SSRI’s (selective serotonin reuptake inhibitors) and include Paxil, Zoloft, Celexa and Lexapro. When the term SSRIs is used, it often refers to their chemical cousins Effexor, Wellbutrin and Cymbalta as well.
The drug companies, “by their sheer economic clout,” have become the single most dominant influence in our healthcare system, and the “ambiguities of children’s mental health and illness make child psychiatry the most vulnerable branch of medicine open to such influence,” says Dr Lawrence Diller, a behavioral-developmental pediatrician and author of, “The Last Normal Child,” in the July 13, 2008, San Francisco Chronicle.
“In this climate,” he explains, “drug company research money, professional medical education and direct advertisements to parents tilt families and doctors to biologically brain-based solutions, rather than non-drug (e.g., parenting and education) approaches.”
That is why we are seeing famous (or infamous) Newsweek cover boys – like a 10-year-old “who has taken 38 psychiatric medications in his short, unhappy life,” he says.
Dr Joseph Glenmullen, author of “Prozac Backlash,” testified at a hearing before the US House Energy and Commerce Committee on February 10, 2005, and explained how important lawsuits have been in unearthing the internal company documents, which reveal the antidepressant-induced suicidality risk. Both the FDA and the pharmaceutical industry knew about this side effect over a decade ago, he said.
Dr Glenmullen noted that the FDA failed to adequately educate doctors and the public and called it a “most dangerous scenario” when neither the doctor nor the patient knows how to recognize antidepressant-induced suicidality.
He pointed out that only Prozac was FDA approved for depressed children, and all other antidepressants studied had failed to demonstrate they were more effective than placebo. He faulted the FDA for failing to require drug manufacturers to tell doctors in the labels that the drugs had been studied and failed to show efficacy.
He noted that one million American children were on antidepressants for everything from shyness to school anxiety to headaches to attention deficit disorder. “How can the FDA allow this to happen when it has acknowledged that the drugs can make children suicidal?” he asked.
“Family doctors write 70% of prescriptions for antidepressants and know little about how to diagnose and treat antidepressant-induced suicidality,” he pointed out.
Once the FDA approves a drug, doctors can prescribe it for any purpose, a practice called off-label prescribing. “Many doctors prescribe many medications off label for children, but none do it as frequently as child psychiatrists,” says Dr Diller.
He advises that none of the psychiatric drugs have been studied for more than two or three months regarding long-term safety or effectiveness with children, with the exception of stimulants used for ADHD. Drug companies oppose this kind of thorough follow-up on drugs “not only because it is expensive, but because they don’t really want to find out whether their drugs continue to work over time or if long-term side effects develop,” he states in the paper, “A Prescription for Disaster,” published by Salon.com on May 23, 2002.
“Currently, that kind of research is a job for the country’s trial lawyers,” he writes.
“But this de facto system of monitoring the effects of drugs requires many casualties before an adverse outcome is discovered or established in the medical and popular literature,” Dr Diller points out.
Highly Paid Hustlers in motion
The “failure of clinical trials to provide safety information about the effects of long-term use is at the heart of the debate about the legitimacy of prescribing psychotropic drugs for children,” according to Vera Hassner Sharav, President of the Alliance for Human Research Protection in the 2003 paper, “Children in Clinical Research: A Conflict of Moral Values,” published in the American Journal of Bioethics.
No SSRI was approved for children before 2003. However, by “the early 1990′s, it didn’t matter that they were not officially approved for use in children: they were commonly given to children as young as 6 years old,” says Professor Jonathan Leo in the 2006 paper, “The SSRI Trials in Children: Disturbing Implications for Academic Medicine.”
He points out that “the child psychiatry profession fully endorsed the use of these drugs well before the FDA approved them, and, in an even odder twist,” he says, “the profession endorsed the use of them well before any of the major studies in children were even published.”
“It appears that one reason for doing the studies in the first place was to justify already well-accepted prescribing patterns,” according to Professor Leo.
“If a trend is created ‘because everyone else is doing it’ then it appears that the child psychiatry profession’s use of these drugs in the late 1990′s more closely resembled a trend instead of a logical scientific undertaking,” he explains.
The first major studies claiming SSRI’s were safe and effective for children began to appear in the late 1990′s. In all the published studies, papers and poster presentations used at medical seminars, conferences and other events to expand the “well-accepted prescribing patterns,” to doctors in every field of medicine, there are the names of the same “Highly-Paid Hustlers,” also known as “key opinion leaders,” because they are supposedly so highly respected by their peers.
They include, but are not limited to, Drs Joseph Biederman, David Dunner, Graham Emslie, Daniel Geller, Robert Gibbons, Frederick Goodwin, Martin Keller, Andrew Leon, John Mann, John March, Charles Nemeroff, John Rush, Neal Ryan, David Shaffer and Karen Wagner.
Dr Biederman and the gang at Harvard almost single-handedly instigated the epidemic in the off-label prescribing of drug cocktails to children, of 2, 3 or even 4 drugs at a time, in combinations that have never been tested on animals much less humans. The mental illness always known as “manic-depression” was now “bipolar disorder,” and in the mid-90′s, Dr Biederman, and a few more “opinion leaders” started claiming that a great number of children were afflicted, possibly even as early as in the womb, some said.
“Most parents have never heard of him, but Joseph Biederman of Harvard may be the United States’ most influential doctor when it comes to determining whether their children are normal or mentally ill,” says Dr Diller, in an article entitled, “Are Our Leading Pediatricians Drug Industry Shills?” in the July 13, 2008, San Francisco Chronicle.
“Biederman and his team,” Dr Diller writes, “are more responsible than anyone for a child bipolar epidemic sweeping America (and no other country) that has 2-year-olds on three or four psychiatric drugs.”
“The science of children’s psychiatric medications is so primitive and Biederman’s influence so great,” he says, “that when he merely mentions a drug during a presentation, tens of thousands of children within a year or two will end up taking that drug, or combination of drugs.”
“This happens in the absence of a drug trial of any kind – instead,” Dr Diller notes, “the decision is based upon word of mouth among the 7,000 child psychiatrists in America.” ”That’s why Iowa Sen. Charles Grassley’s recent revelation that Biederman did not declare $1.6 million in drug company consulting fees is so important, scary and tragic,” he says.
“If true,” Dr Diller notes, “this scandal is yet one more stake in the heart of American academic medicine’s credibility with frontline doctors like him, and more importantly, with the parents of the children he deals with every day.”
Until the “bipolar” profiteering scheme was set in place by publishing a couple bogus studies and then passing them around to doctors all over the country at medical seminars and conventions, manic-depression was unheard of in children. It still is in other counties.
Most parents are not aware of the life-long consequences of a childhood mental-illness diagnosis. Children with medical records showing treatment become ineligible for a wide range of occupations. An early diagnosis can also make it difficult to obtain health insurance for life.
In the age of computerized recordkeeping, there can be no deleting of this damning information. Just as there is no scientific way to prove that anyone has a mental disorder, there is no way to disprove it either. Once diagnosed, a child will never escape the label.
Dr Emslie was busy pumping out new marketing tools last year, this time in the form of a treatment guideline to promote the off-label use of psychiatric drugs to toddlers. However, the “respectable” medical journals continue to publish this kind of trash.
He is the first author on a December 2007 paper in the Journal of the American Academy of Child & Adolescent Psychiatry that reviewed the developmental considerations related to preschool psycho-pharmacological treatment, presenting current evidence bases for specific disorders in early childhood and described the recommended algorithms for medication use in 3- to 6-year-olds.
This “Preschool Psychopharmacology Working Group” claims it was developed to review existing literature and to develop recommendations to guide clinicians considering psycho-pharmacological treatment in very young children. “The purpose of this effort,” the authors note, “is to promote responsible treatment of young children, recognizing that this will sometimes involve the use of medications.”
Not one single psychiatric drug is approved for children under 6; not alone and not together with any other. Yet the Group says it has established algorithms for the treatment of ADHD, disruptive behavior disorders, major depressive disorder, bipolar disorder, anxiety disorders, posttraumatic stress disorder, obsessive-compulsive disorder, pervasive developmental disorders (such as autism) and primary sleep disorders.
On May 5, 2006, United Press International reported on a Duke University study where investigators studied 307 children between the ages of 2 and 5 and claimed they detected signs of depression, anxiety and other mental illnesses. The rate was about the same as with older children and not much lower than within adults, they said. UPI made sure to mention that the research was funded in part by the “pharmaceutical giant Pfizer.”
Judging by the results of this “study,” the “Hustlers” recruited another 30 toddlers as potential customers for daily drug cocktails in one sweep. Notably missing from all the above lists of “disorders” is a condition that could account for half of the stigmatizing labels in one age group, commonly known throughout time as the “Terrible Twos.”
Of all the harmful actions of modern psychiatry, the mass diagnosing and drugging of children is the most appalling with the most serious consequences for the future of individual lives and for society, says Dr Peter Breggin, author of the new book, “Medication Madness.”
Many children who end up seeking help from Dr Breggin are already on four or five drugs at one time. He says millions of children are growing up with “drug-intoxicated brains.”
Not only do these medications suppress spontaneity and volition, he warns, but the psychiatric approach teaches children that they cannot, without medication, learn to manage their own behavior. In effect, the children are taught that they cannot exercise and develop self-determination, autonomy or free will, he explains.
Pennsylvania psychiatrist Dr Stefan Kruszewski also warns that “young children who are medicated do not learn to adapt and develop coping strategies as they move through the developmental stages of childhood.”
“They rely on a false belief that drugs can solve problems,” he says, “rather than relying on their own innate creative potential or the help of family, friends, and schooling.”
“Psychiatry was once plagued by ‘boundary violations,’ where physicians exploited the dependence of their patients,” Dr David Healy explains in the 2006 paper, “The Latest Mania: Selling Bipolar Disorder.” But he says:
“All the indications are that we are now in a new era of drug-related boundary violations. There is perhaps nowhere in medicine where this is more obvious than in the case of bipolar disorders, with adults treated with bizarre cocktails and children put on some of the most lethal drugs in medicine.”
“The extensive prescription of these medications for children,” Dr Diller warns, “without adequate testing for safety and effectiveness in children constitutes a hidden time bomb that could explode with still more casualties.”
“Catastrophic side effects may be rare,” he says, “but they become predictable when we treat so many children with so many drugs.”
“There is nothing more despicable than a doctor knowingly telling normal children they are mentally ill for profit,” says Dr Fred Baughman, author of, “ADHD Fraud – How Psychiatry Makes Patients of Normal Children.”
“Because the children made into ‘patients’ are normal to begin with,” Dr Baughman contends, “those who treat them with psychiatric drugs are guilty not of an iatrogenic medical mistake, but a willful for-profit poisoning.”
“What should we call it when children die pursuant to a fraudulent diagnosis,” he asks. “First degree murder? Second degree murder? Justifiable homicide? Manslaughter?”
In an expert report recently submitted in litigation involving a Paxil-induced suicide by a 13-year-old boy, Dr Glenmullen discusses a case where that question begs to be answered when he tells the court: “It is my opinion to a reasonable degree of medical probability that if GlaxoSmithKline had provided a warning all these years, Benjamin Bratt would still be alive today.”
There are many families suffering all over the country as a result of the drugging-children-for-profit schemes set in place by the Highly-Paid Hustlers. “For us it has been four and a half years without resolution or closure,” says Mathy Milling Downing, whose daughter Candace hung herself in January 2004 after being prescribed Zoloft at age 12 because she was nervous when taking tests at school.
“Every day hurts,” Mathy says. “One never gets over the loss.” Prior to her death, the Downings saw no signs of Candace being depressed or suicidal.
They were not told to watch for signs of suicide. The doctor did not inform them that Zoloft was not approved for children, and they were assured that Zoloft was safe.
The Downings would later learn that their daughter’s physician was on Pfizer’s payroll. “Although we realize that Candace’s doctor only made about $12,000 acting as a Pfizer consultant, it’s not the amount that bothers us,” Mathy says.
“It’s the medical compromise. It’s the lack of informed consent. It’s placing economical gain above the well-being of an innocent child and a trusting family,” she states.
“I just want to know when ‘Greed before Need’ will diminish and doctors will once again place a patient’s well-being first,” she says, “before financial gain.”
“What has happened to the Hippocratic Oath that doctors are supposed to take?” Mathy wants to know.
In “Let Them Eat Prozac,” Dr Healy discusses how he reached his estimates for the high number of suicides and suicide attempts that could be attributed to Prozac alone. An April 2000 paper in the Archives of Psychiatry looked at the rates for suicide attempts on newer antidepressants compared to placebo and reported SSRI rates higher than placebo.
These figures made it possible for him to estimate how many people had made suicide attempts. “If ten per thousand make an attempt on Prozac and five per thousand or less do so on placebo or other antidepressants, and if (as is conventionally estimated) 40 million people worldwide have had Prozac,” he writes, “then there will have been 200,000 more suicide attempts on Prozac than had Prozac not been used.”
“Conventional wisdom is that there is one suicide for every ten attempts,” he explains. “These would give 20,000 suicides over and above the number who would have committed suicide if they had been left untreated or been treated with older agents.”
Dr Healy then accessed the FDA’s Adverse Event Database to look at suicides reported and found there were over 2,000 as of October 1999. “The FDA estimated their database picked up only between one and ten per cent of serious adverse events,” he writes.
“This gives a spread between 20,000 and 200,000 suicides on Prozac,” he concludes.
There is no way to know how many people have suffered needlessly because the drugmakers lied about the suicide risk for so many years. According to Dr Healy, aside from the need to save lives, if emergent suicide linked to a drug is not correctly attributed to treatment, patients suffer a long-lasting injury to their self-esteem and self-confidence as a consequence.
“If patients have engaged in actual suicidal acts as a result of treatment and the connection to treatment is not made, given that prior suicide attempts appear to increase the risk of future successful suicides, it appears possible that the risk of a future successful suicide has been increased accordingly,” he warns in a June 2003 briefing paper on “Antidepressants and Suicide.”
(Written as part of the Paxil Litigation Round-Up, Sponsored by Baum, Hedlund, Aristei & Goldman’s Pharmaceutical Litigation Department www.baumhedlundlaw.com)