2/28/2002 • Antidepressant drug trials turn away most of the depressed population

2/28/2002 • Antidepressant drug trials turn away most of the depressed population

Mark Zimmerman, associate professor of psychiatry and human behavior, director of outpatient psychiatry at Rhode Island Hospital

Brown University

While antidepressants are among the most frequently prescribed medications, most patients treated for major depression in a typical outpatient psychiatric practice would not qualify to take part in a clinical trial for a new antidepressant drug, according to a new Brown University study.

Antidepressant drug trials turn away most of the depressed population

http://www.brown.edu/Administration/News_Bureau/2001-02/01-091.html

Mark Zimmerman, associate professor of psychiatry and human behavior, director of outpatient psychiatry at Rhode Island Hospital

Brown University

While antidepressants are among the most frequently prescribed medications, most patients treated for major depression in a typical outpatient psychiatric practice would not qualify to take part in a clinical trial for a new antidepressant drug, according to a new Brown University study.

Trials to determine the effectiveness of antidepressants have historically evaluated only a small subset of depressed individuals with a very specific clinical profile. People diagnosed with other psychiatric problems and people with mild depression are among those excluded, says the study, which appears in the March 2002 American Journal of Psychiatry.

“When you take any medicine you assume it‚s been found to be effective for your condition,” said Mark Zimmerman, associate professor of psychiatry and human behavior, director of outpatient psychiatry at Rhode Island Hospital, and the study‚s lead researcher. “No one knows for sure whether antidepressants are effective for most of the patients we treat.”

As few as 15 percent of 346 depressed patients evaluated in the Rhode Island Hospital Department of Psychiatry outpatient clinic would have met the eligibility requirements of a standard drug trial, depending on the criteria.

To determine whether the clinic patients would qualify for the drug studies, the researchers reviewed inclusion and exclusion criteria used in 31 antidepressant trials published from 1994 to 1998 in five leading psychiatric journals. Many of the studies excluded patients who had psychotic features, a history of manic episodes, suicide risk, unstable medical illnesses, or a history of drug or alcohol abuse. Several also excluded subjects with eating disorders, obsessive-compulsive disorder or panic disorder.

Nearly all of the studies excluded patients who fell below a cutoff score on a measure of symptom severity, even though they were diagnosed with major depression. “We are not aware of any other medical condition in which individuals with the disorder are routinely excluded because they are not sick enough,” said Zimmerman.

“Drug companies are concerned that individuals with mild depression will respond just as well to a placebo as they will to antidepressant medication,” said Zimmerman. “However, this represents a sizable number of individuals who are prescribed these medicines, especially by primary care physicians.”

The researchers conducted diagnostic evaluations of patients at the Rhode Island Hospital Department of Psychiatry outpatient practice, a group ranging in age from 16 to 65. Excluding patients with any of the features commonly used in efficacy trials eliminated two-thirds of the patients. If patients with an anxiety disorder were also excluded, then more than 85 percent of the patients would not have qualified for a drug study of antidepressants ˆ yet more than 90 percent of the patients in the study for whom prescribing information was available were being treated with antidepressants at the time of the evaluation.

Some extrapolation of antidepressant studies by clinicians will always be necessary, Zimmerman said. It would be impossible to establish the effectiveness of antidepressant medications in every conceivable population of depressed patients. But the current practice of limiting studies to only “pure” moderate-to-severely ill depressives may skew the findings of drug trials, he added. If antidepressants are, in fact, not effective for some of these large subgroups of depressed individuals, their prescription incurs an unjustifiable exposure of risks and side effects, and alternative treatments need to be considered.

Opening antidepressant trials to patients with a wider range of symptoms would allow researchers to learn whether any specific subsets respond or do not respond to a drug. The question now is whether government mandates are necessary to make trials more inclusive, Zimmerman said. There is little motivation for drug companies ˆ whose primary aim is to show that their medication is safe and that it works for some patients ˆ to do this.

“Drug companies have been correct in assuming that if they show their medicine works for a highly select group of depressed patients, physicians will use it for all patients,” said Zimmerman.

This study was supported by grants from the National Institutes of Mental Health. Zimmerman worked with Jill I. Mattia, clinical assistant professor, and Michael A. Posternak, research fellow, in the Department of Psychiatry and Human Behavior at Brown University.

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2/13/2002 • Psychiatrists shift the mood on antidepressants

2/13/2002 • Psychiatrists shift the mood on antidepressants

Matt Weaver

Society-Guardian

The professional body for psychiatrists has conceded that antidepressant pills such as Prozac may only have a 50% success rate in treating depression.
Psychiatrists shift the mood on antidepressants

http://society.guardian.co.uk/mentalhealth/story/0,8150,649503,00.html

Matt Weaver

Society-Guardian

The professional body for psychiatrists has conceded that antidepressant pills such as Prozac may only have a 50% success rate in treating depression.

The Royal College of Psychiatrists, which represents around 10,000 psychiatrists, has withdrawn previous advice that said “six or seven in every 10 depressed people will get better on antidepressants”. Based on the most recent research, new draft advice seen by SocietyGuardian.co.uk says that between only 50% and 65% “will be much improved” if they take antidepressants. For the first time, the new advice also concedes that herbal remedies made from the flower St Johns wort are “about as effective as antidepressants in milder depression”. The latest research, which the RCP stresses has not yet been finalised, is expected to be available next month. The college’s old advice said that antidepressants are not addictive. “There is no evidence that antidepressant drugs caused dependence syndromes,” it said. The new study acknowledges that there is a debate on the subject and points out that “up to a third of people experience withdrawal”. It says withdrawal “seems to be greatest” with Seroxat, the biggest selling antidepressant in the UK which, like Prozac, works by boosting the levels of the brain chemical serotonin. Withdrawal symptoms included nausea, flue like symptoms, anxiety and sweating. In the last few years, prescriptions for antidepressants have more than doubled in England, from 9m in 1991 to 22m in 2000, due largely to the increase of drugs such as Seroxat and Prozac, known technically as selective serotonin reuptake inhibitors or SSRIs. One of the reasons for this sharp uptake was the view that SSRI were effective and relatively problem free, a view brought into question by the RCP’s new advice. The study comes after a report by Health Which? claiming that official advice on antidepressants was misleading. Health Which? also pointed out that recent research suggests a link between suicide and SSRI. The draft RCP guidelines claim that “suicidal thoughts will pass once the depression starts to lift”.

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2/7/2002 • Scandal of scientists who take money for papers ghostwritten by drug companies

2/7/2002 • Scandal of scientists who take money for papers ghostwritten by drug companies

Sarah Boseley
health editor

Guardian

Scientists are accepting large sums of money from drug companies to put their names to articles endorsing new medicines that they have not written – a growing practice that some fear is putting scientific integrity in jeopardy.

Scandal of scientists who take money for papers ghostwritten by drug companies

http://www.guardian.co.uk/Archive/Article/0,4273,4351264,00.html

Sarah Boseley
health editor

Guardian

Scientists are accepting large sums of money from drug companies to put their names to articles endorsing new medicines that they have not written – a growing practice that some fear is putting scientific integrity in jeopardy.

Ghostwriting has become widespread in such areas of medicine as cardiology and psychiatry, where drugs play a major role in treatment. Senior doctors, inevitably very busy, have become willing to “author” papers written for them by ghostwriters paid by drug companies.

Originally, ghostwriting was confined to medical journal supplements sponsored by the industry, but it can now be found in all the major journals in relevant fields. In some cases, it is alleged, the scientists named as authors will not have seen the raw data they are writing about – just tables compiled by company employees.

The doctors, who may also give a talk based on the paper to an audience of other doctors at a drug company-sponsored symposium, receive substantial sums of money. Fuller Torrey, executive director of the Stanley Foundation Research Programmes in Bethesda, Maryland, found in a survey that British psychiatrists were being paid around $2,000 (£1,400) a time for symposium talks, plus airfares and hotel accommodation, while Americans got about $3,000. Some payments ran as high as $5,000 or $10,000. “Some of us believe that the present system is approaching a high-class form of professional prostitution,” he said.

Robin Murray, head of the division of psychological medicine at the Institute of Psychiatry in London, is one of those who has become increasingly concerned. “It is clear that we have a situation where, when an audience is listening to a well-known British psychiatrist, you recognise the stage where the audience is uncertain as to whether the psychiatrist really believes this or is saying it because they themselves or their department is getting some financial reward,” he said. “I can think of a well-known British psychiatrist I met and I said, ‘How are you?’ He said, ‘What day is it? I’m just working out what drug I’m supporting today.'”

Marcia Angell, former editor of the New England Journal of Medicine, wrote a year ago that when she ran a paper on antidepressant drug treatment, the authors’ financial ties to the manufacturers – which the journal requires all contributors to declare – were so extensive that she had to run them on the website. She decided to commission an editorial about it and spoke to research psychiatrists, but “we found very few who did not have financial ties to drug companies that make antidepressants.”

She wrote: “Researchers serve as consultants to companies whose products they are studying, join advisory boards and speakers’ bureaus, enter into patent and royalty arrangements, agree to be the listed authors of articles ghostwritten by interested companies, promote drugs and devices at company-sponsored symposiums, and allow themselves to be plied with expensive gifts and trips to luxurious settings. Many also have equity interest in the companies.”

In September her journal joined the Lancet and 11 others in denouncing the drug companies for imposing restrictions on the data to which scientists are given access in the clinical trials they fund. Some of the journals propose to demand a signed declaration that the papers scientists submit are their own.

The success of Prozac, the antidepressant which became a cult “happy” drug in the 1990s, substantially raised the stakes in psychiatry. Its promotion coincided with the decline of state funding for research, leaving scientists in all areas of medicine dependent on pharmaceutical companies to fund or commission their work. That in turn gave the industry unprecedented control over data and ended with research papers increasingly being drafted by company employees or commercial agencies.

The responsibility of scientists for the content of their papers takes on serious significance in the context of court cases in the US, where relatives of people who killed themselves and murdered others while on SSRIs (selective serotonin reuptake inhibitors) – the class of drug to which Prozac belongs – claimed the drugs were responsible.

According to David Healy, a north Wales-based psychopharmacologist who has given evidence for the families, the companies have relied on articles apparently authored by scientists who may in fact have not seen the raw data.

Dr Healy, who had unprecedented access to the data that the companies keep in their archives, said: “It may well be that 50% of the articles on drugs in the major journals across all areas of medicine are not written in a way that the average person in the street expects them to be authored.” He cites the case brought last year against the former SmithKline Beecham (now GlaxoSmithKline) by relatives of Donald Schell. The court found that the company’s best-selling antidepressant, an SSRI called Seroxat, had caused Schell to murder his wife, daughter and granddaughter and commit suicide.

The company’s defence was based on scientific papers which analysed the results of trials comparing Seroxat with a placebo and found there was no increased risk of suicide for depressed people on Seroxat. But the raw data probably does not support that, argues Dr Healy. Some of the placebo suicides took place while patients were withdrawing from an older drug. When the figures are readjusted without these, he says, they show there is substantially increased risk of suicide on Seroxat.

This raises the question of whether the eminent scientists whose names were on the papers ever saw the raw data from the trials – or saw only tables compiled by company employees, he says.

David Dunner, a professor at the University of Washington, who co-authored one of the papers in 1995, admits he did not see the raw data. “I don’t know who saw it. I did not,” he said. “My role in the paper was that the data were presented to us and we analysed it and wrote it up and wrote references.” His co-author Stuart Montgomery, then of St Mary’s hospital medical school in London, declined to answer calls and emails from the Guardian. The third name on the paper is that of Geoff Dunbar, a company employee.

The World Health Organisation has expressed concern about the ties between industry and researchers. Jonathan Quick, director of essential drugs and medicines policy, wrote in the latest WHO Bulletin: “If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken.”

Guardian Unlimited © Guardian Newspapers Limited 2002

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2/6/2002 • Scientists Find Little, If Any, Proof Ritalin Is Effective

2/6/2002 • Scientists Find Little, If Any, Proof Ritalin Is Effective

Brad Evenson

National Post – Canada 2-6-2

After a painstaking analysis of 62 studies of Ritalin treatment for attention deficit disorder, a team of Canadian researchers says it has found little scientific evidence the drug lives up to its reputation.
Scientists Find Little, If Any, Proof Ritalin Is Effective

http://www.cma.ca/cmaj/index.asp

Brad Evenson

National Post – Canada 2-6-2

After a painstaking analysis of 62 studies of Ritalin treatment for attention deficit disorder, a team of Canadian researchers says it has found little scientific evidence the drug lives up to its reputation.

More than 200,000 Canadian schoolchildren take methyl-phenidate, the generic name for Ritalin, a stimulant drug prescribed to help them concentrate and control their impulsive behaviour. Many parents, teachers and doctors praise the drug for turning around the tumultuous lives of millions of young children.

Yet a meta-analysis published today in the Canadian Medical Association Journal says the clinical trials of the drug have often been biased and poorly constructed. For example, although patients may take Ritalin for years, most trials comparing the drug with a placebo lasted three weeks, with none lasting longer than seven months. In some cases, scientists studying Ritalin ignored or downplayed the impressions of schoolteachers, who thought children taking the drug were no better off than those taking a placebo. Finally, such adverse side effects as insomnia and loss of appetite have not been carefully measured.

“Collectively, these observations likely reflect a less than an ideal state of affairs given the long history of extensive, and ever increasing, use of methylphenidate for ADD particularly in North America for groups that now include pre-schoolers and adults,” conclude the researchers, from the Children’s Hospital of Eastern Ontario and the University of Ottawa.

For a disease that didn’t officially exist before 1987, attention deficit disorder has been remarkably catching. An estimated 5% of children are affected. Several years ago, the definition was expanded to the new name, attention deficit/hyperactivity disorder [AD/HD]. The symptoms include trouble concentrating, talking constantly, running around in a disruptive way, fidgeting and acting impulsively.

Surprisingly, little is known about how Ritalin tames these symptoms, but scientists agree it clearly works in the short term. A positive response to Ritalin, however, does not mean a child has AD/HD; stimulants can temporarily sharpen anyone’s focus. Also, the drug does not raise IQ or remove the learning disabilities that often accompany AD/HD.

“Short-term managed behaviour – that’s important for a lot of kids, but it’s not going to give them the skills that they need to manage for the rest of their lives, because when the medication wears off, they’re back at square one and, in some cases, maybe a little worse off,” says Toronto psychologist Lynda Thompson, co-author of The A.D.D. Book.

As a result, many people are seeking alternatives, including biofeedback and nutritional regimens. These have less dramatic results than Ritalin, but they make parents more comfortable.

Indeed, a University of British Columbia study, also published today in the CMAJ, raises concerns that many children who are prescribed Ritalin don’t need it.

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12/3/2001 • STUDIES ON RITALIN ARE CHILD ABUSE

12/3/2001 • STUDIES ON RITALIN ARE CHILD ABUSE

DOUGLAS MONTERO

NEW YORK POST

“They want to see how much these children can tolerate,” said Vera Hassner Sharav, who heads the New York-based Alliance for Human Research Protection. “The research is absolutely child abuse.”
STUDIES ON RITALIN ARE CHILD ABUSE

http://www.nypost.com/cgi-bin/printfriendly.pl

DOUGLAS MONTERO

NEW YORK POST

“They want to see how much these children can tolerate,” said Vera Hassner Sharav, who heads the New York-based Alliance for Human Research Protection. “The research is absolutely child abuse.”

THE federally funded abuse of children, some as young as 3, has begun in New York City, critics charge. The alleged torture chambers are located at two city locations where doctors will conduct Ritalin experiments on more than 80 city kids between the ages of 3 and 8.

Advocates, handcuffed by the lack of money, are waging a battle to stop the nationwide $6 million, 72-week study at the six institutions, which include NYU Medical Center and the New York Psychiatric Institute.

Two-thirds of the 264 kids will be under 5. Researchers want kids with symptoms of attention deficit hyperactivity disorder (ADHD) who have never been medicated.

Advocates who have seen the protocol describing the study say the experiment will subject kids to a “horrific” psychological hellride.

The kids will start getting Ritalin at small daily dosages, which will gradually increase to 7.5 mg and 10 mg three times a day, depending on how the drug affects them.

The side effects that, in part, determine dosage limits are headaches, abdominal pain, difficulty sleeping, fever, nausea, dizziness, chest pain and, in some rare cases, Tourette’s disorder, depression and psychosis.

The kids who cope with 10 mg will get a dosage of 15 mg – so researchers can see what happens.

“They want to see how much these children can tolerate,” said Vera Hassner Sharav, who heads the New York-based Alliance for Human Research Protection. “The research is absolutely child abuse.”

Once a dosage amount is established, researchers will spend five weeks alternating amounts and sometimes giving placebo sugar pills to see how the kids react. Parents and teachers who record the reaction won’t be told about the dosage change.

Fake classrooms with two-way mirrors will be set up to study the kids like lab rats when researchers wean them off Ritalin. The “child’s behavior could get worse,” the protocol states.

The protocol says kids will be referred by schools, clinics and hospitals. The authors apparently didn’t know recruiting for such experiments in schools violates city laws. In any case, parents can pull their kids out at any time.

An official at the Psychiatric Institute, who didn’t want to be identified, said more than a quarter-million pediatricians already prescribe Ritalin to children under 6, and the study will help doctors “make intelligent decisions.”

Advocates question why nearly 70 percent of the kids in the Psychiatric Institute study are black and Latino. A racial breakdown for the NYU study was unavailable because its researcher, Dr. Howard Abikoff, didn’t return messages left at his office.

Dr. Ellen Isaacs, a member of an advocacy group in Washington Heights, where the Psychiatric Institute is located, plans to meet with the local community board to complain.

“They want poor minority kids because their parents are more easily coerced to sign up,” she said.
Copyright 2001 NYP Holdings, Inc. All rights reserved.

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11/12/2001 Prozac triggers increase in aggression in mice

11/12/2001 • Prozac triggers increase in aggression in mice

Emma Young
San Diego

New Scientist

The anti-depressant Prozac causes a dramatic increase in aggressive behavior in mice the day after the drug is administered, US researchers have found.
Prozac triggers increase in aggression in mice

http://www.newscientist.com/news/news.jsp?id=ns99991553

Emma Young
San Diego

New Scientist

The anti-depressant Prozac causes a dramatic increase in aggressive behavior in mice the day after the drug is administered, US researchers have found.

Prozac, or fluoxetine, has been associated with isolated reports of suicide and crimes of violence in people. “But this has been difficult to study in other animals,” says George Wagner of Rutgers University. “Our findings represent the first demonstration that the drug can actually increase defensive aggression in other species.” When the mice received alcohol along with Prozac, their aggression scores on the following day were even higher. “Our data indicate a potentially serious interaction between Prozac and alcohol,” Wagner adds.

However, the implications for the millions of people who take Prozac worldwide are unclear, Wagner says. The mice in his study were given a single, very high dose of the drug. The effects of regular, much smaller doses over a long period of time might be different, he says. John Mann of Columbia University, US, says: “This is a very interesting observation. But individual case reports of people exhibiting suicidal or aggressive behavior have been found with practically every psychotropic medication. Every double blind study of people taking Prozac to date has not indicated an association with increased aggression.

“Protruding object Mann’s team investigated the effects of Prozac alone, alcohol alone, and Prozac plus alcohol on two types of aggression: offensive and defensive. “Offensive would be two males fighting over territory, for example,” says Mann. “Defensive involves an aggressive response to a painful or frustrating stimuli. “Mice in the three drug groups were put in a cage together, to investigate offensive aggression, or given a mild electric shock, to investigate defensive aggression.

In the second case, the mice’s tendency to bite an inanimate object protruding into their cage in response to the shock was measured. Prozac is thought to work by prolonging the presence of the neurotransmitter serotonin in the brain. Low levels of serotonin are associated both with alcohol consumption and with aggression. The team expected that alcohol alone would boost aggression – and that this effect would be counteracted by an accompanying dose of Prozac. Prozac alone was expected to decrease aggressive behavior. On the day the drugs were given, that was exactly what they found. But on the second day, they found that defensive aggressive behavior in mice that had received Prozac alone rocketed by between 15 and 20 per cent, compared with baseline measurements.

In mice that had also received alcohol, it increased by between 20 and 25 per cent. There was no effect on offensive aggressive behavior. Impulsive behavior Prozac causes a decrease in levels of a serotonin metabolite called 5-hydroxyindoleacetic acid (5HIAA). Low levels of 5HIAA have been associated with suicides, especially violent ones, as well as with other violent or impulsive behavior. Wagner’s team recorded the lowest levels of 5HIAA on the day after the mice received the Prozac. “We found lower levels of 5HIAA in our mice long after they received fluoxetine,” says Wagner. “That may help explain their increased aggression. “The team now plans to investigate the effects of chronic Prozac use on aggression in animals. Wagner presented his research at the Society for Neuroscience annual conference in San Diego.13:10 12 November 01For exclusive insights into the most important developments in science and technology this week, see New Scientist Print Edition Subscribe to New Scientist Print Edition and get free access to 10 years of the magazine in our online archive Correspondence about this story should be directed to latestnews@newscientist.com. Sign up for our free newsletter

The Society for Neuroscience

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6/10/2001 • SSRI treatment suppresses dream recall frequency but increases subjective dream intensity in normal subjects.

6/10/2001 • SSRI treatment suppresses dream recall frequency but increases subjective dream intensity in normal subjects.

Pace-Schott EF, Gersh T, Silvestri R, Stickgold R, Salzman C, Hobson JA.

Laboratory of Neurophysiology, Department of Psychiatry, Harvard Medical School, Boston, MA 02115, USA. edward_scott@hms.harvard.edu

The decrease in dream frequency during SSRI treatment may reflect serotonergic REM suppression while the augmented report length and bizarreness during acute SSRI discontinuation may reflect cholinergic rebound from serotonergic suppression.

SSRI treatment suppresses dream recall frequency but increases subjective dream intensity in normal subjects.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11422727&dopt=Abstract

Pace-Schott EF, Gersh T, Silvestri R, Stickgold R, Salzman C, Hobson JA.

Laboratory of Neurophysiology, Department of Psychiatry, Harvard Medical School, Boston, MA 02115, USA. edward_scott@hms.harvard.edu

The decrease in dream frequency during SSRI treatment may reflect serotonergic REM suppression while the augmented report length and bizarreness during acute SSRI discontinuation may reflect cholinergic rebound from serotonergic suppression.

Clinical lore and a small number of published studies report that the selective serotonin reuptake inhibitors (SSRIs) intensify dreaming. This study examines the dream effects of paroxetine and fluvoxamine in order to both increase clinical knowledge of these agents and to test an important potential method for probing the relationship between REM sleep neurobiology and dreaming in humans. Fourteen normal, paid volunteers (4 males, 10 females; mean age 27.4 year, range 22–39) free of medical or neuropsychiatric symptoms as well as of psychotropic or sleep affecting drugs completed a 31-day home-based study consisting of: 7 days drug-free baseline; 19 days on either 100 mg fluvoxamine (7 Ss) or 20 mg paroxetine (7 Ss) in divided morning and evening doses; and 5 days acute discontinuation. Upon awakening, subjects wrote dream reports, self-scored specific emotions in their reports and rated seven general dream characteristics using 5-point Likert scales. Dream reports were independently scored for bizarreness, movement and number of visual nouns by three judges. REM sleep-related measures were obtained using the Nightcap ambulatory sleep monitor. Mean dream recall frequency decreased during treatment compared with baseline. Dream report length and judge-rated bizarreness were greater during acute discontinuation compared with both baseline and treatment and this effect was a result of the fluvoxamine-treated subjects. The subjective intensity of dreaming increased during both treatment and acute discontinuation compared with baseline. Propensity to enter REM sleep was decreased during treatment compared with baseline and acute discontinuation and the intensity of REM sleep increased during acute discontinuation compared with baseline and treatment.

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9/25/2000 – FDA – “Safety For Sale” – USA Today

More evidence of the FDA’s “dirty laundry” was exposed in today’s USA Today
this morning. Although nothing new, it is marvelous to see the mainstream
press exposing it once again.

Let’s hope that soon something will be done to address this serious public
health risk – the “safety assurances for sale” policies of the FDA. Generally
all that is done is something to assure the public that “all is well” and
there is nothing to fear as they did in the FDA hearings on Prozac and
suicide in 1991. One month after I returned to Utah after that FDA hearing
that assured us of the safety of Prozac, a mother, in my own neighborhood,
butchered and bludgeoned her three children with a hammer and sheep sheering
knife before stabbing herself to death in a cold turkey attempt to get off
Prozac and several other meds her doc (also on Prozac) had put her on. She as
so many could find no one who would wean her off the drugs that she continued
to complain were “turning her brain to mush”.

Do I believe that the blood of those innocent children and their mother is on
the hands of the FDA? You bet I do! I had just witnessed my friend Suzanne
Johnson of Atlanta, GA stand before the FDA and tell them how Prozac had
induced a rare blood disorder that was slowly taking her life and that her
blood was on their hands. (She died the following year.) She also said that
the blood of many others would be on their hands if they did not take a firm
stand in warning the public of the dangers of this drug. They refused and
thousands, upon thousands more have had their lives destroyed as a result.
Five on the panel who voted that day had financial ties to the pharmaceutical
companies, but they were allowed to sign a wavier stating that they would not
allow their money to sway them. Obviously they think we were all born
yesterday.

This practice of buying safety assurances from the FDA MUST end. Hopefully
the we, the ICFDA, can help that to happen. The FDA has not protected the
public for years. That is extremely well documented in Morton Mintz’s
wonderful book A THERAPUTIC NIGTHMARE (1969).

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org
_______________________

http://www.usatoday.com/news/washdc/ncssun06.htm

09/25/00- Updated 12:24 AM ET

FDA advisers tied to industry

By Dennis Cauchon, USA TODAY

More than half of the experts hired to advise the government on the safety
and effectiveness of medicine have financial relationships with the
pharmaceutical companies that will be helped or hurt by their decisions, a
USA TODAY study found.

These experts are hired to advise the Food and Drug Administration on which
medicines should be approved for sale, what the warning labels should say and
how studies of drugs should be designed.

Number of drug experts available is limited

The experts are supposed to be independent, but USA TODAY found that 54% of
the time, they have a direct financial interest in the drug or topic they are
asked to evaluate. These conflicts include helping a pharmaceutical company
develop a medicine, then serving on an FDA advisory committee that judges the
drug.

The conflicts typically include stock ownership, consulting fees or research
grants.

Federal law generally prohibits the FDA from using experts with financial
conflicts of interest, but the FDA has waived the restriction more than 800
times since 1998.

These pharmaceutical experts, about 300 on 18 advisory committees, make
decisions that affect the health of millions of Americans and billions of
dollars in drugs sales. With few exceptions, the FDA follows the committees’
advice.

The FDA reveals when financial conflicts exist, but it has kept details
secret since 1992, so it is not possible to determine the amount of money or
the drug company involved.

A USA TODAY analysis of financial conflicts at 159 FDA advisory committee
meetings from Jan. 1, 1998, through last June 30 found:

At 92% of the meetings, at least one member had a financial conflict of
interest.

At 55% of meetings, half or more of the FDA advisers had conflicts of
interest.

Conflicts were most frequent at the 57 meetings when broader issues were
discussed: 92% of members had conflicts.

At the 102 meetings dealing with the fate of a specific drug, 33% of the
experts had a financial conflict.

“The best experts for the FDA are often the best experts to consult with
industry,” says FDA senior associate commissioner Linda Suydam, who is in
charge of waiving conflict-of-interest restrictions.

But Larry Sasich of Public Citizen , an advocacy group, says, “The industry
has more influence on the process than people realize.”

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Study Links Older Bipolar Drug to Fewer Suicides

http://www.nytimes.com/2003/09/17/health/17SUIC.html

Dr. Frederick K. Goodwin, senior author of the study and director of the psychopharmacology research center at George Washington University Medical Center

Journal of the American Medical Association

The new study, published today in The Journal of the American Medical Association, found that patients taking Depakote were 2.7 times as likely to kill themselves as those taking lithium. Earlier studies by others had also found that lithium could prevent suicide, but today’s report is the first to compare suicide and attempted suicide rates in lithium and Depakote users. The study was based on medical records of 20,638 patients aged 14 and older in Washington State and California who were treated from 1994 to 2001.

Lithium, an old and inexpensive drug that has fallen out of favor with many psychiatrists, is better than the most commonly prescribed drug, Depakote, at preventing suicide in people who have manic-depressive illness, researchers are reporting.

People with the illness, also called bipolar disorder, swing back and forth between bleak spells of depression and periods of high excitability that may run the gamut from euphoria to rage. From 1.3 percent to 1.5 percent of people in the United States suffer from bipolar disorder, and their risk of committing suicide is estimated to be 10 to 20 times that of the rest of the population.

Perhaps because patients are more likely to seek medical help when they are depressed than when they are manic, the disorder is often misdiagnosed at first as depression alone, but antidepressants are not the correct treatment for bipolar disorder and may in fact make it worse.

The new study, published today in The Journal of the American Medical Association, found that patients taking Depakote were 2.7 times as likely to kill themselves as those taking lithium. Earlier studies by others had also found that lithium could prevent suicide, but today’s report is the first to compare suicide and attempted suicide rates in lithium and Depakote users. The study was based on medical records of 20,638 patients aged 14 and older in Washington State and California who were treated from 1994 to 2001.

Solvay Pharmaceuticals, a maker of lithium, paid for the study, but did not influence the findings or the way they were reported, the authors said.

The study included 53 actual suicides and 383 attempted suicides that led to hospitalization. But the researchers, as well as Depakote’s manufacturer, cautioned that because this study was based only on patients’ records, it was not conclusive.

Precisely how lithium might prevent suicide is not known, although it is believed to help regulate levels of serotonin, a brain chemical that influences mood.

“Lithium is clearly being underutilized,” said Dr. Frederick K. Goodwin, the senior author of the study and director of the psychopharmacology research center at George Washington University Medical Center. The drug can save lives, he said, adding, “The real tragedy is that a lot of young psychiatrists have never learned to use lithium.”

Lithium, which can smooth out the highs and the lows of bipolar disorder, was first used in the 1950’s, and in the 1970’s was the first drug to be designated a “mood stabilizer” by the Food and Drug Administration. But the drug has been around for so long that its patent has expired and generic versions exist, meaning that lithium cannot generate substantial earnings for industry, Dr. Goodwin said. Drug companies promote newer, more profitable drugs like Depakote.

Some difficult cases referred to Dr. Goodwin turn out to be people who have never taken lithium because their psychiatrists, often under 40, never thought of prescribing it. But Dr. Goodwin also emphasized that lithium did not work for everyone and that other drugs like Depakote were also needed.

Dr. John Leonard, a spokesman for Abbott Laboratories, the maker of Depakote, questioned the findings. Dr. Leonard said that studies looking back at patients’ records were inherently flawed and not as reliable as studies in which patients were randomly assigned by researchers to take one drug or the other. He said conclusions could not be drawn from the data, and doctors should not base treatment decisions on it.


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9/1/1999 • Persistently increased density of serotonin transporters in the frontal cortex of rats treated with fluoxetine during early juvenile life

9/1/1999 • Persistently increased density of serotonin transporters in the frontal cortex of rats treated with fluoxetine during early juvenile life

V V, Moll GH, Bagli M, Rothenberger A, Ruther E, Huether G
Department of Adult Psychiatry, University of Gottingen, Germany.

J Child Adolesc Psychopharmacol 1999; 9(1); 13-24; discussion 25-6

This is the first empirical demonstration of long-lasting effects of the administration of a selective serotonin reuptake inhibitor during juvenile life on the maturation of the central serotonergic system.
Persistently increased density of serotonin transporters in the frontal cortex of rats treated with fluoxetine during early juvenile life.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10357514&dopt=Abstract

V V, Moll GH, Bagli M, Rothenberger A, Ruther E, Huether G
Department of Adult Psychiatry, University of Gottingen, Germany.

J Child Adolesc Psychopharmacol 1999; 9(1); 13-24; discussion 25-6

This is the first empirical demonstration of long-lasting effects of the administration of a selective serotonin reuptake inhibitor during juvenile life on the maturation of the central serotonergic system.

This experimental animal study was performed in order to assess possible long-term effects of the administration of the selective serotonin reuptake inhibitor fluoxetine (Prozac) during early periods of juvenile life on the developing central serotonergic and noradrenergic systems. Fluoxetine was administered via the drinking water (5 mg/kg/day) for a period of two weeks to very young (day 25) and somewhat older (day 50) rats. The effect of this treatment on the density of serotonin and noradrenaline transporters was measured by ligand-binding assays in various brain regions. The Bmax-values of [3H]-nisoxetine binding were not affected by either treatment schedule, but a significant increase of the Bmax-values of [3H]-paroxetine binding was found in the brains of early fluoxetine-treated rats. This increase was restricted to the frontal cortex and persisted long after the termination of the treatment into adulthood (day 90). The most likely explanation of this observation is a stimulatory effect of the fluoxetine treatment on the outgrowth of serotonergic projections in the frontal cortex of very young rats.

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