NOVEMBER 2006: News on SSRIs, other Psych Drugs and Related IssuesNovember 16 2006 at 7:05 PM
16 Nov PRESS RELEASE-Swedish Psych Assoc: "IMMENSE NUMBER" patients worse on SSRI/SNRIs
|November 16 2006, 7:06 PM |
Press Release November 16, 2006
An immense number of patients get worse from new antidepressant drugs, says Vice President of The Swedish Psychiatric Association
|Speaking on antidepressants the Vice President of The Swedish Psychiatric Association, Dr. Christina Spjut, said Sunday that "an immense number of persons get worse from this". She said that many persons take these drugs for years "where the antidepressant drugs make them continue to be depressed".|
|/24-7PressRelease/ - HAGERSTEN, SWEDEN, November 16, 2006 - This announcement on Swedish national television, coming from one of the top psychiatric authorities in the country, is sensational. |
Millions and millions of persons take new antidepressant drugs - in the belief that they are "safe and effective" - as psychiatrists, pharmaceutical companies and medical agencies, like the FDA, have told them.
But now a top psychiatric authority tells them that they in an immense number of cases "get worse from this" and that the antidepressant drugs themselves in many cases "make them continue to be depressed". The VP of The Swedish Psychiatric Association - the national member organisation of the World Federation of Mental Health - further said about the harmful effects of antidepressant drugs and the fact that doctors don't believe what the patients tell them, that there is "a considerable lack of knowledge about these side effects" and that the patients must tell their doctors "that this exists, and then this doctor has to find out about it".
It is a little known fact that pharmaceutical companies have had to work hard to show any positive effect of new antidepressants (SSRIs and SNRIs) to get approval of the drugs. Even if they are experts in asking the right questions and getting the answers they want from their clinical trials, it has been almost impossible to complete two studies where the drug is more "effective" than placebo (which is the requirement for approval of the drug from a medical agency, like the FDA). From deep within the archives of clinical trials the hidden harmful effects of antidepressant drugs have emerged the last two years. But the fact that these drugs cause suicidality and violence is not what psychiatrists and pharmaceutical companies have told the public.
Instead the public and doctors have for many years heard that these drugs are "safe and effective" and if some bad effect showed up it was explained away with the "underlying disease". The problem was said to be compliance - the patients had to continue to take the drugs long enough for the depression to go away.
But the Vice President of The Swedish Psychiatric Association has now announced that this was false: For many persons "the antidepressant drugs make them continue to be depressed".
Patients should repeat the words of this psychiatric authority when speaking to their doctors: Tell the doctors about the harmful effects of antidepressants, "that this exists, and then this doctor has to find out about it". They should tell the doctors that the cause of their bad feelings very likely is that "the antidepressant drugs make them continue to be depressed". They should get their doctors to gradually reduce the antidepressant drug under careful supervision.
Patients should also be aware of the new deceitful campaign of biological psychiatry. As with all earlier psychiatric drugs the catastrophic effects can be announced first when a campaign for a new drug or drug cocktail is about to start. The coming campaign, (well-known for the VP Dr. Spjut), in Sweden and the rest of the Western world is the sale of "Bipolar Disorder" (Manic-Depression). Patients are to be told their "old" diagnosis of depression was a bit wrong and that the "correct" diagnosis was "Bipolar" (both these diagnoses are of course completely subjective, there is no objective confirmable evidence for any form of "chemical imbalance" in the brain). And then the treating doctor is supposed to add even more toxic substances - antipsychotic drugs like Zyprexa and Risperdal - to the antidepressants.
The antidepressant era is about to end - it should be replaced by real solutions to personal problems, not by more false diagnoses and more toxic psychiatric drugs.
writer from Sweden - investigating psychiatry
New UK Mental Health Bill still "too draconian".
|November 17 2006, 6:44 PM |
The mental health bill
The government has published yet another bill intended to replace the Mental Health Act. But campaigners say it is still too draconian. David Batty explains
Friday November 17, 2006
What is this bill?
The bill is the government's third attempt in eight years to reform the 1983 Mental Health Act. The government first published proposals to reform the act in 1999. A draft bill followed in 2002 but was strongly opposed by mental health campaigners and psychiatrists. A second draft bill was published in 2004, but this was again widely opposed. After the second draft bill was heavily criticised by a parliamentary committee, the government abandoned it in March this year but announced its intention to press ahead with the most controversial aspects of the draft mental health bill in shorter, streamlined legislation. A third bill was published after the Queen's speech in November 2006
What does the new bill consist of?
It retains the draft bill's proposal to remove a legal loophole that allows people with severe personality disorders, previously known as psychopaths, to avoid treatment by arguing they get no benefit from it. Psychiatrists oppose this measure, arguing it will turn them into jailers. Measures to extend the use of compulsory treatment outside hospital to patients in the community also remain. These will allow restrictions such as curfews to be imposed on patients in the community. Mental health charities and the Royal College of Psychiatrists fear this may dissuade people with mental health problems from seeking help.
Why do ministers want to remove the treatability clause?
Ministers' plans to detain people with personality disorders who have not committed a crime were first announced after the murder of Lin Russell and her six-year-old daughter Megan in Kent in 1996. Their killer, Michael Stone, had been left free to commit the crime because his severe personality disorder was considered untreatable and he could not be detained under the Mental Health Act. The government estimated there were up to 2,400 similar people in the UK, described as having dangerous and severe personality disorders, of whom it estimated between 300 and 600 lived in the community rather than prison or secure mental hospitals. However, the vice-president of the Royal College of Psychiatrists (RCPsych), Dr Tony Zigmond, believes there are as few as a dozen such people in the community.
What else will the bill do?
The Department of Health says the bill will close a legal loophole that means thousands of people with learning disabilities or dementia may be kept indefinitely in hospitals and nursing homes because they are unable to communicate their wishes. The health secretary and Welsh ministers will also be able to reduce the time before a patient undergoing compulsory treatment has their case reviewed by a mental health tribunal. The bill retains the plan to give patients the right to choose their own representative, who currently must be their nearest relative. This representative will be able to apply for a patient to be discharged from hospital or to trigger an assessment of their case.
Why does the government want to extend compulsory treatment?
The government says allowing the compulsory treatment of patients in the community will help those caught in a "revolving door" of relapse and readmission because they fail to take their medication. Ministers claim the shorter bill will limit these extended powers, so that only patients assessed in hospital can be forcibly treated in the community. But Dr Zigmond says this could still cover patients whose assessments were carried out years ago.
What do mental health campaigners think?
The Mental Health Alliance, a group of 78 organisations including the Law Society, the RCPsych and the charities Mind, Sane and Rethink, is opposed to the latest version of the bill. It is staging a lobby of Parliament on November 28 to protest against the proposed legislation."
WHITE HOUSE lobbies UK to allow Big Pharma Drug-Pushing scheme IN UK.
|November 17 2006, 7:03 PM |
Sarah Boseley, health editor
Tuesday November 14, 2006
The White House is lobbying British ministers to allow the world's main drug companies unrestricted access to the NHS as part of a package of free market reforms for the service.
The US government is positioning itself behind the giant pharmaceutical firms, predominantly based in America, which have been piling pressure on the body that approves drugs for use in hospitals and for prescription by GPs.
The drug companies claim that they are being held back by the National Institute for Clinical Excellence and have separately lobbied for it to be reformed.
In a surprising intervention, the US deputy health secretary, Alex Azar, forced the issue in London yesterday, ahead of talks with officials following a trip to the US last week by the health secretary, Patricia Hewitt. He said attempts to use rationing mechanisms such as Nice to cut soaring drugs bills would stifle innovation [! is that what they call toxic drugs!]- an argument that is constantly made by the pharmaceutical industry.
Allowing all new drugs to be used in the NHS would result in the companies "fighting it out" on price, Mr Azar said, which would drive the drug bill down.
He made it clear that he was also in favour of the drug companies being allowed to advertise directly to patients. At the moment they may only advertise to doctors.
He also wanted to share the US experience of offering private insurance packages to people on Medicare - the healthcare scheme provided by the government to the poor and elderly. It might be possible for the UK government to consider something similar, he suggested, so that everyone could choose either a basic healthcare deal or top it up themselves if they wanted to pay for more than the state could afford.
Speaking to the Guardian, Mr Azar said healthcare systems in all wealthy countries were expensive, and costs were increasing at a time when budget constraints were getting more real as the population aged. "On the other side we have to focus on long-term innovation," he said. "How are we making sure that we don't take steps on cost containment that are short-sighted and prevent the investment in long-term biomedical research and development and innovation, so that when my kids are senior citizens we have the next generation and next, next, next generation of drugs?"
The White House arguments will increase the mounting pressure on Nice, which is regularly castigated by patient groups and drug companies when it rejects a new medicine from use in the NHS on cost grounds.
Recently there was an outcry over its ruling that new drugs for Alzheimers should be given only to those with moderate disease, and yesterday cancer charities objected to its preliminary ruling that a new drug, Tarceva, for lung cancer, should not be used in the NHS. Ministers have been directly lobbied by drug companies arguing that its decisions are ill-founded and inappropriate.
Yesterday Mr Azar emphasised the close contact his office has with the Department of Health and with European ministries. The links had been particularly useful in dealing with pandemic influenza preparedness, he said.
He said he had "some great discussions" with Ms Hewitt in the US last week and had followed them up with her officials and the Treasury.
"In all of our systems it is so easy to make the decision to cut costs today by going after drug prices, and to not focus on what will be the impact on long-term innovation," he said.
"I try to remember to advise people first off that we will never balance our budget going after drug prices. They are a relatively small proportion of the entire healthcare budget in our system."
Drugs and devices could keep people out of hospital and allow them to be cared for in their own homes, so saving costs, he said"
Maybe NICE should point out the unusually high level of risks (considering its hardly been on the market) of serious side effects of the alzheimer's drug - instead of saying its because of the cash? Maybe then people will understand that the drugs aren't safe?
Check October's thread and you'll see how DEADLY those side effects have ALREADY proven to be, but...
...I suppose we musn't upset Pfizer Klaus or he won't leave a present under the government tree (in fact he'll avoid the UK altogether apparently, according to recent threats).
Alzheimer Drug's "FREQUENT" ADRs: Brain Hemorrage, Cardiac Failure,Pneumonia, Aggression..
|November 17 2006, 7:24 PM |
| So are those 'support groups' et al, AND THE WHITE HOUSE, while pushing for drug companies actually trying to kill UK grandmamas or grandpapas for pharma incentives? Or do they just not bother to research?
EBIXA is ALSO known as NAMENDA:
FREQUENT side effects ALREADY are listed as "Cardiac Failure" (Death), "Cerebrovascular Accidents and Transient Ischemic Attacks" (Strokes), "Pneumonia" (which often kills vulnerable elderly) - and re behavioural problems experienced by people with Alzheimers? "AGGRESSIVE REACTION" (ie AGGRESSION). All are listed under "FREQUENT".
"...Body as a Whole: Frequent: syncope. Infrequent: hypothermia, allergic reaction.
Cardiovascular System: Frequent: cardiac failure. Infrequent: angina pectoris, bradycardia, myocardial infarction, thrombophlebitis, atrial fibrillation, hypotension, cardiac arrest, postural hypotension, pulmonary embolism, pulmonary edema.
Central and Peripheral Nervous System: Frequent: transient ischemic attack, cerebrovascular accident, vertigo, ataxia, hypokinesia. Infrequent: paresthesia, convulsions, extrapyramidal disorder, hypertonia, tremor, aphasia, hypoesthesia, abnormal coordination, hemiplegia, hyperkinesia, involuntary muscle contractions, stupor, cerebral hemorrhage, neuralgia, ptosis, neuropathy.
Gastrointestinal System: Infrequent: gastroenteritis, diverticulitis, gastrointestinal hemorrhage, melena, esophageal ulceration.
Hemic and Lymphatic Disorders:Frequent: anemia. Infrequent: leukopenia.
Metabolic and Nutritional Disorders: Frequent: increased alkaline phosphatase, decreased weight. Infrequent: dehydration, hyponatremia, aggravated diabetes mellitus.
Psychiatric Disorders: Frequent: aggressive reaction. Infrequent: delusion, personality disorder, emotional lability, nervousness, sleep disorder, libido increased, psychosis, amnesia, apathy, paranoid reaction, thinking abnormal, crying abnormal, appetite increased, paroniria, delirium, depersonalization, neurosis, suicide attempt.
Respiratory System: Frequent: pneumonia. Infrequent: apnea, asthma, hemoptysis.
Skin and Appendages: Frequent: rash. Infrequent: skin ulceration, pruritus, cellulitis, eczema, dermatitis, erythematous rash, alopecia, urticaria.
Special Senses: Frequent: cataract, conjunctivitis. Infrequent: macula lutea degeneration, decreased visual acuity, decreased hearing, tinnitus, blepharitis, blurred vision, corneal opacity, glaucoma, conjunctival hemorrhage, eye pain, retinal hemorrhage, xerophthalmia, diplopia, abnormal lacrimation, myopia, retinal detachment.
Urinary System: Frequent: frequent micturition. Infrequent: dysuria, hematuria, urinary retention.
Events Reported Subsequent to the Marketing of Namenda Worldwide
The following adverse events of possible importance for which there is inadequate data to determine the causal relationship to memantine treatment have been reported to be temporally associated with memantine treatment and are not described elsewhere in labeling: atrioventricular block, bone fracture, carpal tunnel syndrome, cerebral infarction, chest pain, claudication, colitis, dyskinesia, dysphagia, gastritis, gastroesophageal reflux, grand mal convulsions, intracranial hemorrhage, hepatic failure, hyperlipidemia, hypoglycemia, ileus, impotence, malaise, neuroleptic malignant syndrome, acute pancreatitis, aspiration pneumonia, acute renal failure, prolonged QT interval, restlessness, Stevens-Johnson syndrome, sudden death, supraventricular tachycardia, tachycardia, tardive dyskinesia, and thrombocytopenia.
Memantine induced neuronal lesions (vacuolation and necrosis) in the multipolar and pyramidal cells in cortical layers III and IV of the posterior cingulate and retrosplenial neocortices in rats, similar to those which are known to occur in rodents administered other NMDA receptor antagonists. Lesions were seen after a single dose of memantine. In a study in which rats were given daily oral doses of memantine for 14 days, the no-effect dose for neuronal necrosis was 6 times the maximum recommended human dose on a mg/m2 basis. The potential for induction of central neuronal vacuolation and necrosis by NMDA receptor antagonists in humans is unknown.
DRUG ABUSE AND DEPENDENCE
Controlled Substance Class: Memantine HCl is not a controlled substance.
Physical and Psychological Dependence: Memantine HCl is a low to moderate affinity uncompetitive NMDA antagonist that did not produce any evidence of drug-seeking behavior or withdrawal symptoms upon discontinuation in 2,504 patients who participated in clinical trials at therapeutic doses. Post marketing data, outside the U.S., retrospectively collected, has provided no evidence of drug abuse or dependence.
N-methyl-D-aspartate (NMDA) antagonists: The combined use of Namenda with other NMDA antagonists (amantadine, ketamine, and dextromethorphan) has not been systematically evaluated and such use should be approached with caution.
Effects of Namenda on substrates of microsomal enzymes: In vitro studies conducted with marker substrates of CYP450 enzymes (CYP1A2, -2A6, -2C9, -2D6, -2E1, -3A4) showed minimal inhibition of these enzymes by memantine. In addition, in vitro studies indicate that at concentrations exceeding those associated with efficacy, memantine does not induce the cytochrome P450 isozymes CYP1A2, CYP2C9, CYP2E1 and CYP3A4/5. No pharmacokinetic interactions with drugs metabolized by these enzymes are expected.
Effects of inhibitors and/or substrates of microsomal enzymes on Namenda: Memantine is predominantly renally eliminated, and drugs that are substrates and/or inhibitors of the CYP450 system are not expected to alter the metabolism of memantine.
Acetylcholinesterase (AChE) inhibitors: Coadministration of Namenda with the AChE inhibitor donepezil HCl did not affect the pharmacokinetics of either compound. In a 24-week controlled clinical study in patients with moderate to severe Alzheimer’s disease, the adverse event profile observed with a combination of memantine and donepezil was similar to that of donepezil alone.
Drugs eliminated via renal mechanisms: Because memantine is eliminated in part by tubular secretion, coadministration of drugs that use the same renal cationic system, including hydrochlorothiazide (HCTZ), triamterene (TA), metformin, cimetidine, ranitidine, quinidine, and nicotine, could potentially result in altered plasma levels of both agents. However, coadministration of Namenda and HCTZ/TA did not affect the bioavailability of either memantine or TA, and the bioavailability of HCTZ decreased by 20%. In addition, coadministration of memantine with the antihyperglycemic drug GlucovanceÒ (glyburide and metformin HCl) did not affect the pharmacokinetics of memantine, metformin and glyburide. Furthermore, memantine did not modify the serum glucose lowering effect of GlucovanceÒ.
Drugs that make the urine alkaline: The clearance of memantine was reduced by about 80% under alkaline urine conditions at pH 8. Therefore, alterations of urine pH towards the alkaline condition may lead to an accumulation of the drug with a possible increase in adverse effects. Urine pH is altered by diet, drugs (e.g. carbonic anhydrase inhibitors, sodium bicarbonate) and clinical state of the patient (e.g. renal tubular acidosis or severe infections of the urinary tract). Hence, memantine should be used with caution under these conditions.
US and the White House: 'Just Say No To Drugs - Then Take your Prozac'.
|November 17 2006, 7:56 PM |
It could only happen in America. Couldn't it?
The answer it seems is NO. The White House are now lobbying the UK for more freedom for Big Pharma to push drugs on you and YOUR children - by direct advertising to people (just like in the US, and look what it did for them) here instead of Doctors only as has been the case up to now and by bypassing the safety net of NICE and going straight to the NHS.
DCI Crime and Narcotics Center
The Director of Central Intelligence Crime and Narcotics Center monitors, reviews, and delivers information about international trafficking in illegal drugs and international organized crime to our nation's leaders and law enforcement agencies.
Former Director of Central Intelligence William Webster created what became today's DCI Crime and Narcotics Center in April 1989. The center is staffed by people from the 13 agencies which make up the US Intelligence Community, including the CIA, and from law enforcement agencies.
The people who serve in the Crime and Narcotics Center can never say they have a slow day because the war on drugs and crime goes on around the clock and never takes a holiday. They have a big job, and many people look to them for help.
The Crime and Narcotics Center's staff's many jobs include:
Estimating the amount of illegal drugs—coca, opium poppy, and marijuana—produced around the world. Their estimates about illegal drugs help our government leaders determine the level of the drug threat to our country and also how committed other countries are to the war on drugs.
Assisting law enforcement agencies break up drug and organized crime groups
Helping law enforcement agencies detect and capture illegal drug shipments
By working closely with CIA offices and other agencies on crime and drug issues, the people who work in the Crime and Narcotics Center play a key role in helping destroy many drug and organized crime organizations.
What the Crime and Narcotics Center staff does seems like a lot of work, and it is. Did you know that the men and women of the Crime and Narcotics Center are moms and dads, too? They work hard to protect you and their own children from the pain and sorrow and criminal activities that are often the result of using illegal drugs.
The DCI Crime and Narcotics Center invites you to look at some of its publications about drugs..."
Clearly they don't have the time to spend looking at similar, but PRESCRIBED, drugs and their rates of increase or how it affects the real levels of crime:
"...Noting the millions taking high-powered antidepressants like Prozac, Grossman observes, ''we medicate, incarcerate and police ourselves at rates never seen before.''
Yet, he says, the biggest factor for lower crime rates is that ''we are lying about the data.''
''The ''Crimestat'' program made cops accountable for bringing down crime ... When the NYPD police union went over the data the crime rates doubled in New York City if the proper classifications were applied.''
Other than murder (held down by medical technology), the pressure on the cop on the beat means ''police artificially 'bring crime down' and the root causes of the crime get off scott free, because we cook the books.'' ..."
"...Just a few more examples:
''In 2004, the Policeman's Benevolent Association in New York City revealed officials were ''cooking the books'' to lower crime statistics.''
''Felonies were classified as misdemeanors, rapes were logged as ‘''inconclusive incidents.''
''Attempted murder in a drive-by-shooting where the victim is missed might be reclassified as ''criminal mischief.''
''LAPD reported a 28 percent drop in violent crime in 2005, the same year the department reclassified domestic assaults in which the victim suffered minor injuries or had no injuries.''
Since the FBI NIBRS counts only offense reports, not city charges, serious domestic violence – often tied to pornography use—is magically reduced by a city charge.
''On October 23, 2003, five New Orleans cops were fired for downgrading violent crime states.''
''On January 8, 2005, four members of the Broward County sheriff's command staff were fired. ''Sometimes a suspect would admit to dozens of crimes but only be charged with one.''
''In Atlanta, 22,000 crimes were left out of the crime reports. In New York, the crime rates doubled in a precinct when the proper classification was applied by the police union. The list goes on.''
''The cops try to do their job, but they are handcuffed by some feel-good administrators who will not back them on controversial issues.''
''Compstat relies on intimidation [and some] administrators will not investigate the numbers that make them look good.''
''Everyone is happy except the citizens who get nothing but a false sense of security about the safety of their cities.''
4-fold increase in UK Adhd drugs, and the "McDonaldisation of childhood mental health"
|November 17 2006, 8:42 PM |
Use of drugs to treat hyperactive children soars fourfold in ten years
By KIRSTY WALKER, Political Correspondent
Last updated at 23:07pm on 10th November 2006
Reader comments (4)
Hyperactivity: 32,000 children are being treated at a cost of £13.5million a year.
Prescriptions for so-called 'chemical cosh' drugs to treat hyperactive children have risen fourfold since 1997, official figures reveal.
The trend has alarmed experts because Ritalin-type drugs have been linked to sudden deaths in the U.S. and Britain and its use has been under review in this country.
Department of Health figures show GPs wrote a record 384,000 prescriptions for Ritalin and related drugs last year - nearly 7,400 a week.
The total of annual prescriptions has for the first time overtaken the number of youngsters thought to have Attention Deficit Hyperactivity Disorder.
Around 32,000 children are being treated at a cost of £13.5million a year. But the National Institute for Clinical Excellence says as many as 366,000 - or 5 per cent - of youngsters under 18 have the disorder.
This will fuel fears that Ritalin is being used as an easy option to sedate healthy children rather than tackling the cause of their hyperactivity through diet and other means.
Concerns about the use of such drugs have mounted in recent years, amid evidence that they cause heart problems, dizziness and insomnia.
They have been blamed for nine deaths in the UK and more than 50 in America in one year. Dozens of youngsters have had serious heart problems.
But a recent study found fish oil is better at treating hyperactivity. Experts say six capsules a day can vastly improve children's behaviour without the side-effects of the drugs.
Liberal Democrat spokesman for children Annette Brooke said: 'Parents will be eager that questions surrounding the safety of drugs like Ritalin are answered as soon as possible.
'The Government owes it to the thousands of concerned parents to be honest about the side-effects of these behaviour-altering drugs.
'More and more children are being prescribed drugs like Ritalin, but we must make sure parents are aware of all the available treatments.
'More GPs should be offering nutritional counselling and behavioural therapy before considering prescribing drugs to these young children.'
Dr Sami Tamimi, a consultant child and adolescent psychiatrist, said: 'This is a concerning trend which I call the McDonaldisation of childhood mental health.
'It is the search for an easy cure that fits in with our fast lifestyles and gives us a quick answer. This has resulted in an increase in the medicalisation of childhood problems.
'The long-term administration of these drugs can cause damage to the heart. There has been an increase in strokes, heart attacks and sudden deaths linked to these drugs.
'There is a worrying gap in our knowledge about what happens when they are given over a long period of time.
'There are already concerns about the psychological effects, but we do not know what will happen to people who have been taking these drugs for 20 or 30 years.
'These drugs have chemical elements which are the equivalent of speed and cocaine. It is time the medical profession held up its hands and said we have got this wrong.'
Swiss firm Novartis, maker of Ritalin - or methylphenidate - says the drug has a long record of being a safe and effective medication. [Site NB: New Labour won its first election with the aid of funding by Novartis and various other US sources - could that be something to do with it?]
Health Minister Andy Burnham said discussions are taking place in Europe about whether formal studies are needed into the drug's safety. [!!]
He said: 'Since methylphenidate was authorised in the UK, representations regarding its safety have been received from MPs, patients and healthcare professionals.
'Some of these have specifically questioned the need for further research into its long-term safety.
'It is recognised that there is limited information about the longterm efficacy and safety of methylphenidate. Stimulants such as methylphenidate are known potentially to affect weight gain and growth.'
Ritalin is one of at least three drugs recommended by the NHS for Attention Deficit Hyperactivity Disorder in young people for whom other treatments have failed - despite doctors' fears about side-effects.
But there have been reports of cardiovascular disorders, hallucinations, suicidal thoughts, drowsiness, dizziness, abdominal pain, decreased appetite, nausea and early waking. At least nine deaths have been reported to the UK's Medicines and Healthcare Products Regulatory Agency since it became available in the early Nineties.
It belongs to a class of drugs called methylphenidates - in the same pharmaceutical family as cocaine and amphetamines.
The stimulant fires up parts of the brain involved in concentration, attention and activity. But it also decreases restlessness, leaving ADHD sufferers calmer and moderating their moods. It is not known how it has these opposite effects on the brain.
But it can also raise blood pressure, which is thought to be responsible for triggering heart problems in some users.
U.S. research found Ritalin may cause lasting changes to the brain. Rats given it as infants felt less pleasure and were more prone to despair as adults. .."
PRESS RELEASE - MHRA & LILLY *FAIL* TO INVESTIGATE STRATTERA PSYCHIATRIC REACTIONS
|November 24 2006, 11:46 AM |
"Press Release November 20, 2006
ADHD drug Strattera - new warnings, but the British MHRA didn't care to investigate 600 cases of suicidality and 12 000 "psychiatric reactions"
The British medical agency MHRA will soon issue new warnings for Strattera but didn't care to investigate the reported 12000 "psychiatric reactions" from the drug. And even if number of reports of suicidality has doubled since last year the MHRA has accepted the PR-analysis of Eli Lilly as its own.
/24-7PressRelease/ - HAGERSTEN, SWEDEN, November 20, 2006 - In its new report about the ADHD drug Strattera, expected to be published by the end of the month, the British Medicines and Healthcare products Regulatory Agency (MHRA) will issue new warnings about the harmful effects of the drug. This time about the risk for sudden cardiac death in connection with Strattera "treatment".
But the report will not take up all the "psychiatric reactions" known by the agency for almost a year. The reason is the MHRA didn't care to investigate them.
In January the agency wrote in its Risk:Benefit Assessment about, what it called, the "large number of psychiatric reactions" from Strattera. It said it had requested Eli Lilly "to perform a cumulative review of all psychiatric disorders reported for atomoxetine [Strattera]".
This review was however not submitted in January and thus was not part of the evaluation done by MHRA at the time.
And still in the beginning of August no evaluation of these, at that time, more than 12 000 reported "psychiatric reactions", had been done. Eli Lilly had submitted no review. The MHRA explained that this would change: It had "asked [Eli Lilly] that it is submitted by 9 August. Upon receipt the data will be considered within Europe and consideration given to what regulatory action, if any, is appropriate."
But no consideration could be given, as Eli Lilly neither this time submitted any review.
As a consequence, in the beginning of September the MHRA announced there would be no review of all these "psychiatric reactions". When Eli Lilly didn't submit any documents to the MHRA by August 9 the agency dropped the request. Instead the agency started to refer to the analysis done by the FDA, considered by the FDA Pediatric Advisory Committee at its meeting on 22 March 2006. However the FDA review covered parts of all these reactions and was completed already in September 2005 - the MHRA knew all about it a long time ago.
This means that the British MHRA, leading the current "safety review" of Strattera in Europe, didn't care to investigate what the agency itself called the "large number of psychiatric reactions". It didn't even get in any biased data about these harmful effects from the manufacturer Eli Lilly.
Warnings that Strattera increase the risk of suicidality were issued internationally in September 2005 after Eli Lilly announced a "new analysis" of its clinical trials of the drug.
The number of reports of suicidality and self-injurious behaviour in connection with Strattera had as of May 2006 reached - 600! The number has doubled since September 2005.
Despite the fact that reported cases of suicidality are now over 600, the MHRA has failed to set up an independent investigation of these horrendous harmful effects.
The agency has - as earlier - just accepted the review of Eli Lilly. The Lilly review from January this year (of earlier cases of suicidality) is an excellent example of how to explain away suicides, suicide attempts and suicidal ideation caused by psychiatric drugs. That the reports of suicidality doubled in just some months has not affected the operation of the MHRA - the agency continues to let the manufacturer explain away the harmful effects caused by the psychiatric drug.
Instead of protecting the welfare of children, the MHRA takes part in the forceful drugging of created young "patients" with the alleged psychiatric brain disorder ADHD (without any objective abnormality).
For the sake of children a full independent review of Strattera and the large number of cases of aggression, hostility, homicidal behaviour and ideation, psychosis, abnormal behaviour, suicides, suicide attempts and suicidal ideation must be done promptly.
Psychiatrists, Eli Lilly and medical agencies should no longer be allowed to hide the harmful effects of the drug.
writer from Sweden - investigating psychiatry
CALIFORNIA top law official invesitgating Drug Makers ANTIPSYCHOTIC MARKETING
|December 1 2006, 5:55 PM |
California investigates antipsychotic medications
Update: 6:11 PM ET Nov 3, 2006
(Updates to include Pfizer's receipt of subpoena in the sixth paragraph and adds comment from Lilly spokesman in the fourth paragraph.)
California's top law-enforcement official is investigating drug makers' marketing practices for blockbuster antipyschotic medications.
At least four pharmaceutical companies - AstraZeneca PLC (AZN), Eli Lilly & Co. (LLY), Bristol-Myers Squibb Co. (BMY) and Pfizer Inc. (PFE) - have disclosed in recent days they received subpoenas from the California attorney general's office seeking information about their respective antipsychotics. The drugs are approved to treat bipolar disorder and schizophrenia.
Eli Lilly, which makes Zyprexa, and AstraZeneca, maker of Seroquel, indicated that the subpoenas received in September sought information about their marketing practices for the antipsychotics, as well as the drugs' status on California's "formulary," or list of preferred drugs for a state insurance program.
Lilly of Indianapolis said in a regulatory filing Friday its subpoena was related to "our efforts to obtain and maintain Zyprexa's status on California's formulary." Also, Lilly said the subpoena concerned "remuneration of health care providers." Lilly spokesman Phil Belt said the company is cooperating with the request for information. AstraZeneca of the U.K. disclosed its subpoena in a document posted on its Web site last week.
New York-based Bristol-Myers "has received a subpoena from the California state Department of Justice seeking documents in connection with" Abilify, Bristol-Myers' antipsychotic, spokesman Craig Stoltz told Dow Jones Newswires Friday. "Bristol-Myers is cooperating with the investigation." California's attorney general heads the state justice department.
Pfizer of New York also has received a subpoena from the California attorney general's office seeking information about the Geodon antipsychotic, spokesman Bryant Haskins told Dow Jones Newswires Friday. The company is cooperating fully with the request, which was received in September, he said.
Tom Dressler, a spokesman for the California attorney general, confirmed subpoenas were issued to AstraZeneca and Eli Lilly but declined to comment about other companies. He said the office is "trying to get more information about the marketing of these specific products and their status on the Medi-Cal formulary," referring to the state insurance program.
The marketer of another leading antipsychotic, Johnson & Johnson (JNJ) of New Brunswick, N.J., couldn't immediately be reached.
Newer antipsychotics have become big moneymakers for drug companies, with Zyprexa posting $4.2 billion in sales and Seroquel generating $2.76 billion last year. Abilify, a newer drug, posted sales of $912 million in 2005.
But the drugs also have faced scrutiny over their effectiveness and safety. One government-funded study released earlier this year found that an older drug, clozapine, was more effective in treating certain patients with schizophrenia than three newer drugs: Zyprexa, Seroquel, and J&J's Risperdal. Clozapine is sold under the brand Clozaril by Novartis AG (NVS) of Switzerland.
In another government-funded study, an older antipsychotic called perphenazine was found to have similar effectiveness to three newer ones: Risperdal, Seroquel and Pfizer's Geodon. This study showed Zyprexa to be more effective than the other drugs, but also linked it to more weight gain and higher blood sugar.
Last year, Lilly established a $690 million fund to settle lawsuits that generally alleged Zyprexa led to diabetes or related problems in people taking the drug. The company said the claims were without merit.
J&J has previously received inquiries from federal investigators over its marketing of Risperdal, according to regulatory filings. J&J said it was cooperating and responding to the subpoenas.
More recently, a study concluded there was little benefit of using antipsychotics to treat symptoms of Alzheimer's disease, despite the relatively common practice of doctors prescribing the drugs for that use.
AstraZeneca said last week it's in the initial stages of responding to the California request for information, but a spokeswoman declined further comment. "
Pfizer on defensive, defends its cunning plan to sell more drugs in the UK
|December 1 2006, 6:04 PM |
Pfizer defends its distribution deal
Pfizer, the world’s largest drugs company, has written to MPs to defend its new distribution deal with Alliance-Boots against accusations that it poses a threat to patient safety and a blowout in NHS costs, The Times
In a leaked letter, Pfizer addresses mounting concerns in Parliament about the new contract, which was signed in September and will mean that all UK chemists, dispensing doctors and hospitals buy Pfizer prescription medicines directly from Pfizer through UniChem, the wholesaling arm of Alliance-Boots.
The new system, which Pfizer says
is designed to prevent counterfeit drugs entering the supply chain, circumvents traditional UK pharmaceutical wholesalers and will mean that Pfizer deals directly with every chemist in the UK.
The American company is fighting a growing political backlash against the project. Critics say that it will create a monopoly over the supply of Pfizer drugs, which could cost the NHS money and lead to delays in getting key medicines to patients.
The Pfizer letter, dated October 27, claimed that 33 MPs who had signed up to an early day motion against the deal were the victims of “misconception and myths”.
“We believe (the early day motion) to be based on inaccurate information provided by wholesalers that we have not chosen to partner with,” Owen Smith, Pfizer’s head of government affairs, writes. “Pfizer ran a competitive appointment process . . . Other wholesalers . . . were intimately involved in this process. During this period they did not express any concerns regarding the impact of our reforms on either patients or the NHS. We feel their campaign to mobilise opposition . . . is entirely motivated by commercial self-interest.”
Mr Smith claims that concerns that UniChem may not be able to ensure complete coverage of all pharmacies across the UK, creating a possible threat to patients, were groundless.
Jim McGovern, Labour MP for Dundee West, who tabled the motion after complaints from constituents, rebutted Pfizer’s claims. He said that the suggestion that his efforts had been based on lobbying by the company’s competitors was “untrue” and “offensive”.
“Mr McGovern’s motion . . . is based on inaccurate information provided by wholesalers that we have not chosen to partner with.
“We feel that their [other wholesalers’] campaign to mobilise opposition to our proposals is entirely motivated by commercial self-interest.”
— Owen Smith, Pfizer’s head of government affairs
“Pfizer’s letter seems to suggest that my early day motion was based on my being lobbied by their competitors. This is simply untrue and the mere suggestion is slightly offensive.
“In my mind there are enough unanswered questions and serious concerns for the OFT to launch a full investigation into this deal. I hope that in the next few weeks they will be announcing that indeed they will.”
— Jim McGovern, Labour MP for Dundee West "
DANISH STUDY SSRIs in pregnancy 34% & 84% higher risks of congenital malformation
|December 1 2006, 6:13 PM |
http://www.indystar.com/apps/pbcs.dll/article?AID=/20061108/BUSINESS/61108031NEW YORK (Reuters Health) - The use of selective serotonin reuptake inhibitor (SSRI) antidepressant drugs early in pregnancy seems to moderately raise the risk of congenital malformations in offspring, suggests the results of a Danish population-based cohort study.
"Human data on the teratogenicity of SSRIs are limited," note Dr. Pia Wogelius from Aarhus University Hospital and colleagues in the November issue of Epidemiology.
During the study period, a reference cohort of 150,780 women who were not prescribed an SSRI gave birth to 5112 (3.4 percent) children with congenital malformations, whereas 1051 women who filled a prescription for SSRIs any time during early pregnancy gave birth to 51 (4.9 percent) children with congenital malformations.
Therefore, women who used an SSRI during pregnancy had a 34 percent higher relative risk of delivering an infant with a congenital malformation compared with those that did not.
The 453 women who filled SSRI prescriptions during the second or third month of pregnancy, a key time for "organogenesis," gave birth to 31 (6.8 percent) children with congenital deformities. These women had an 84 percent higher relative risk of having an infant with a congenital malformation.
It's unclear, the authors note, whether the effects of SSRI use were causal or due to factors related to the underlying disease for which SSRIs were prescribed. However, the finding that the association between SSRI use and risk of congenital malformations was stronger during the second or third month of pregnancy is consistent with a causal effect.
"There was no evidence that the association was specific to particular malformations."
Further studies, the team concludes, are needed to confirm these findings and to clarify whether the risk is attributable to SSRIs, to underlying psychiatric disease, or to other confounding factors.
SOURCE: Epidemiology, November 2006.
© Reuters 2006. All Rights Reserved. | Learn more about Reuters "
UK, GSK facing Bitter Pill, as NHS notes GSK's overcharge of £280 MILLION A YEAR x 5
|December 1 2006, 6:31 PM |
How greedy can these companies get?
Glaxo may face bill for £1 billion
09 November 2006
"BRITAIN'S largest drugs company is facing a bitter pill in the form of a bill from Whitehall that could be for over £1 billion.
An independent report on behalf of the Department of Health has revealed that GlaxoSmithKline, which has a research headquarters in Stevenage, may have over-charged the NHS by a staggering £280 million a year for at least five years.
GlaxoSmithKline, which sells over £1.3 billion worth of life-saving drugs to the NHS every year, agreed to price cuts in 1999 after talks with the Government.
But the Pharmaceutical Price Regulation Scheme (PPRS) independent arbitration panel, set up by the Department of Health and chaired by Lord Preston of Mile End, allegedly found the company had continued to bill the NHS the full price for another five years after agreeing the price savings.
Fearing the big bill, GlaxoSmithKline has even warned shareholders it may be financially liable for the error if they have to pay back the over-charging.
The company has also gathered a legal team to fight the claim in the high court.
A spokesman for GlaxoSmithKline said: "We believe we have delivered in excess of the savings required by the NHS under the 1999 scheme, and have asked to appeal the decision of the arbitration panel.
"In the meantime, we are continuing to work with the Department of Health to resolve the matter."
FDA put WARNING on TAMIFLU re DELIRIUM & HALLUCINATIONS
|December 1 2006, 6:50 PM |
FDA Put Warning On Bird Flu Meds
November 13, 2006 8:59 p.m. EST
Megan Shannon - All Headline News Staff Writer
(AHN) - The FDA is adding a new warning to the flu medication, Tamiflu. The new label will recommend that those who take the drug should be monitored closely as cases of delirium and hallucinations have increased this year.
The FDA received more than 100 reports of this adverse behavior in Tamiflu patients, mostly in Japan. The behavior, however, has not been linked to the drug as these can be sever flu symptoms.
The FDA is also afraid to take the medication off the market as it has proved to be the only things that can effectively treat Bird Flu.
[ADMIN NOTE: It hasn't proved effective and there IS something that research has shown to be VERY effective, but the pharma industry can't make a profit from it, and the FDA are only interested in passing profitable pharma products: http://www.nutraingredients.com/news/ng.asp?n=65394-razei-bar-sambucol-bird-flu 26/01/2006 - Sambucol, a standardized extract of black elderberry, has been found to fight the avian flu virus H5N1, revealed British researchers last week...]
If the disease is able to mutate into something passed easily amongst humans, officials say a pandemic is possible [ad nauseum. Say "Thank you FDA", Drug Companies].
The warning label already existed on Tamiflu bottles sold in Japan. There, 24.5 million prescriptions of Tamiflu were filled last year compared to only 6.5 million in the US. The FDA expects Tamiflu usage to increase in the US.
The FDA carried a former label mentioning seizure and confusion. When approached about the increased reports last year the FDA said it would monitor the reports and make a decision this year."
FDA, paid by the Drug Companies to review new drugs, seek "safety budget" increase
|December 1 2006, 8:38 PM |
So don't the FDA members get a salary outside of the industry they're "watching" (purportedly) - or are they like the MHRA - 100% funded by the pharmaceutical industry?
Perhaps the MHRA should follow the FDA's lead and ask their bosses, the drug companies, for a nice increase in salary as an incentive to do what they're meant to do. Getting around to investigating the 10,988 adverse psychiatric reactions reported in 3 years and the 600 cases of suicidality on Strattera springs to mind just as a start, being that they've approved that same old failed SNRI for children diagnosed as having 'ADHD'.
FDA seeks drug safety budget boost from pharma
by Emilie Reymond
21/11/2006 - The US Food and Drug Administration (FDA) and the pharmaceutical industry are in strong negotiations to decide how much drug companies will pay the agency to review new drugs from the end of next year, when the current law expires.
Last week, the FDA's deputy commissioner Scott Gottlieb said that pharma companies should contribute additional funds so the agency can study the drugs' safety once they reach the market.
The US drug industry is now negotiating the fourth version of the Prescription Drug User Fee Act (PDUFA) with the regulator – the outcome could change radically the landscape for pharma companies.
Until now, user fees paid by firms have primarily been used to review the safety and efficacy of new drugs before they are approved to be sold on the market.
However, during a speech at the Manhattan Institute last week, Gottlieb recommended to increase fees in order to hire extra staff to monitor pharmaceuticals once they are marketed.
The Pharmaceutical Research and Manufacturers of America, the industry's trade association which represents US leading pharmaceutical and biotech companies, refused to comment until the negotiations have concluded but stressed that the fee formula – which allows to calculate the fees – was among the features of the bill endorsed by the industry, and that it continues to support it.
Drugmakers began paying fees to the agency in 1992 in a bid to get a faster drug review system under PDUFA.
Since then, PDUFA has been renewed three times and the third iteration expires in October next year.
What was supposed to be only supplemental now represents more than half of the budget for drug review and in 2007, the FDA is expected to collect more than $86m (€67m) in new drug user fees.
However, it is important to put things into context and note that the European equivalent of the FDA, the EMEA, has three quarters of its budget based on industry fees and the UK's drug approval body is entirely funded by pharma companies.
Meanwhile a source close to the FDA told In-PharmaTechnologist.com that while boosting fees to increase the FDA's post-approval supervisory functions was a good intention, it would not change the fact that the pharma industry has a powerful voice and it will keep putting pressure on the regulator.
“PDUFA is a very attractive thing for pharma companies as it allows the FDA to speed up the drug review process,” the source said.
“It has been renewed until now not because it is good, but because it is convenient for the industry.”
The source added that it didn't mean that the FDA's drug safety system would be improved but the FDA would be more economically pressured by drug firms.
A single drug now takes over $1.2bn to develop due to the complexity and duration of the trials required, added to the need to comply with strict regulations, and the industry will be happy to pay more if it allows to speed up things but only if companies get to define the conditions, according to the source.
Drug safety concerns intensified after Merck pulled arthritis pill Vioxx from the market two years ago when a study showed long-term use doubled the risk of heart attack and stroke.
In addition, a report on the FDA's drug approval process by the Institute of Medicine (IOM) published in September said that the agency needs more budget and manpower to ensure it keeps its focus on the safety of the drugs it regulates, not only before approval, but also throughout the time they are on the market.
"We found an imbalance in the regulatory attention and resources available before and after drug approval," said at the time Sheila Burke, deputy secretary and chief operating officer of the Smithsonian Institution and chair of the committee.
"Staff and resources devoted to preapproval functions are substantially greater. Few high-quality studies are conducted after approval."
The FDA admitted that more needed to be done to ensure the safe and effective use of prescription drugs, however it pointed out that much progress and reform of its safety oversight enterprise was already under way. "
Despite the studies, Big Pharma continue to peddle SSRIs to PREGNANT WOMEN
|December 1 2006, 8:42 PM |
If Big Pharma cared one iota about the unborn fetus, at a bare minimum, it would call off its hired-guns traveling around the country peddling SSRI antidepressants to pregnant women by convincing doctors to prescribed the drugs and ignore the studies and FDA warnings that say SSRIs are associated with serious birth defects.
Less than a month ago, on October 16, 2006, the first lawsuit in the nation was filed against GlaxoSmithKline in which an infant charges that his life-threatening lung disorder was caused by exposure to the SSRI Paxil in the womb during his mother's pregnancy.
Eric Jackson was born in Denver, Colorado on October 28, 2004, with persistent pulmonary hypertension of the newborn (PPHN), a condition in which the infant,s arteries to the lungs remain constricted after birth and limit the amount of blood flow to the lungs and oxygen in the bloodstream.
Immediately after birth Eric had to be placed on a ventilator and eventually had to be placed on an oscillating ventilator for a month.
In his 2 short years on earth, Eric has undergone two cardiac catherizations, and another procedure to combat gastral reflux caused from being on a ventilator for so long. Since birth, he has remained on oxygen and medications to help him breathe and he continues to suffer with eating and digestive problems.
With their lawsuit, Eric's parents hope to recover the medical and other expenses incurred in treating, and attempting to cure Eric,s condition, as well as the related illnesses. Some of the related health problems may not even surface until Eric is a teenager.
A study in the October 3, 2006 Archives of Pediatrics and Adolescent Medicine by Dr Agnes Whitaker, MD, of Columbia University and the New York State Psychiatric Institute, and colleagues, reported that low birth weight infants who require mechanical ventilation, with no obvious disability early on, can have subtle and cognitive deficits discernable at age 16.
The study sample represented a cohort of babies who were born at or admitted to one of three hospitals in New Jersey between September 1, 1984 and June 30, 1987.
The research team said, two factors, male gender and days of ventilation were predictors of motor problems. For each additional week of mechanical ventilation, they said, total and oral motor problem scores were higher by 0.33 and 0.14 points, respectively.
Legal analysts predict that Glaxo will attempt to reach early settlements with the families of infants born with birth defects because the company in no way wants injured toddlers paraded in front of a jury.
Karen Barth Menzies is one of Eric's attorneys. She is a partner at Baum Hedlund, a national pharmaceutical products liability law firm with offices in Los Angeles, Washington, DC and Philadelphia, where she heads the Pharmaceutical Antidepressant Litigation Department.
Ms Menzies has been waging legal battles against the SSRI makers on behalf of injured consumers for more than a decade and she currently represents many other families in Paxil birth defect cases
Jennifer Liakos is an associate attorney at Baum Hedlund in Los Angeles, and she is also a member of the firm's Pharmaceutical Antidepressant Litigation Department, handling Paxil birth defect cases. She explains that between 10% to 20% of babies born with PPHN do not survive, even when they receive treatment.
Having been the leader in the Paxil litigation against Glaxo for years now, and through their intensive litigation and discovery, Baum Hedlund has evidence that reveals specifics relating to Paxil and birth defects. Eric's attorneys do not have to newly learn the inter-workings of Glaxo because they know how the company operates regarding Paxil and how they analyze or fail to analyze data.
According to Ms Menzies, studies have shown that infants who are exposed to selective serotonin reuptake inhibitor antidepressants (SSRIs), after the 20th week of gestation are more likely to develop PPHN than infants who were not exposed to an SSRI during pregnancy.
In addition to Paxil, the other SSRIs sold in the US include Prozac by Eli Lilly; Zoloft, from Pfizer; Celexa and Lexapro, from Forest Laboratories; and Luvox, from Solvay. Wyeth markets Effexor, a serotonin-norepinephrine inhibitor.
Adding to the problem of curtailing the prescribing of SSRIs to pregnant women, is the fact that SSRI makers have doctors prescribing the drugs for many other conditions besides depression, and often for off-label uses, meaning they are not approved by the FDA.
According to Dr Jay Cohen, author of, "Over Dose: The Case Against The Drug Companies," the "drug companies have marketed SSRI antidepressants vigorously not only to psychiatrists, who are supposed to have some expertise with these drugs, but also to family practitioners, pediatricians, gynecologists, internal medicine specialists, and anyone else who can pen a prescription."
"But this doesn't mean, he says, "that they possess in-depth knowledge of SSRIs or their actions and toxicities.
A study from the University of Georgia in the June 2006, Journal of Clinical Psychiatry, found that 75% of the people prescribed antidepressants received them for a reason not approved by the FDA.
Little Eric's lawsuit contends that when allowing Paxil to be prescribed to pregnant women, Glaxo has an ongoing duty of pharmacovigilance. The FDA describes the term pharmacovigilance to mean "all scientific and data gathering activities relating to the detection, assessment, and understanding of adverse events."
This includes, the agency notes, the use of pharmacoepidemiologic studies and activities "undertaken with the goal of identifying adverse events and understanding, to the extent possible, their nature, frequency, and potential risk factors."
"During the entire time Paxil has been on the market in the US," Ms Menzies says, "FDA regulations have required Glaxo to issue stronger warnings whenever there existed reasonable evidence of an association between a serious risk and Paxil."
"FDA regulations specifically state," she explains, "that a causal link need not have been proven before a new warning is issued and they explicitly allow Glaxo to issue a new warning without prior FDA approval."
Ms Menzies reports that research as far back as October 3, 1996 in the New England Journal of Medicine, by Dr Christina Chambers and colleagues, of the Department of Pediatrics, Division of Dysmorphology and Teratology, at the University of CaliforniaSan Diego, indicated a risk of PPHN in babies born to mothers taking SSRIs.
For this study, the researchers identified 228 pregnant women taking Prozac between 1989 through 1995, and compared the outcomes of their pregnancies with those of 254 women who were not taking Prozac.
The study found that babies exposed to the Prozac, during the third trimester of pregnancy, had significantly higher rates of premature delivery, respiratory difficulties, admissions to special care nurseries, jitteriness, and poor neonatal adaptation including cyanosis on feeding.
There have also been studies specific to the use of Paxil during pregnancy that have shown respiratory problems in exposed infants upon delivery. For instance, in 2003, researchers at the Motherisk Program at the University of Toronto, reported that exposure to Paxil in late pregnancy was associated with a significantly higher rate of neonatal complications among 55 exposed newborns, when compared to infants exposed to Paxil in early pregnancy or to newborns with no exposure, and respiratory distress was the most commonly reported adverse reaction.
In June 2004, the journal, Prescrire International, reported that newborns exposed to SSRIs toward the end of pregnancy had breathing and suction problems and showed signs of agitation, and altered muscle tone. The study estimated that 20% to 30% of infants were effected and warned that doctors should be aware of the risks when considering treatment during pregnancy with Paxil, Celexa, Prozac, Zoloft, and Lexapro.
The following month, on July 9, 2004, WebMd reported that over the past decade the FDA had received "hundreds" of reports of adverse effects with infants born to mothers taking SSRIs.
That same month, the FDA changed the labeling for all SSRIs, warning that upon delivery, some infants exposed to SSRIs required respiratory support, tube feeding and prolonged hospitalizations.
In May 2005, a University of Pittsburgh study in the Journal of American Medical Association, combined the previous research and found that women who took SSRIs late in pregnancy had a three times higher risk of giving birth to infants suffering from serious respiratory problems, jitteriness, and irritability in the first couple of weeks after birth.
The drugs involved in this study also included the serotonin norepinephrine reuptake inhibitor Effexor. The researchers estimated that in any given year in the US, at least 80,000 pregnant women are prescribed the drugs. According to psychiatrist, Dr Eydie Moses-Kolko, the lead author of the study, serious respiratory problems develop in about one out of 100 infants born to these women.
As a follow-up to her findings of breathing problems in the previous Prozac study in 1996, Dr Chambers, now an assistant professor of pediatrics at the University of California, San Diego, and colleagues, performed a case control study of women on SSRIs who gave birth between 1998 and 2003, to determine whether PPHN was associated with exposure to SSRIs in late pregnancy.
The results of the study published in the February 9, 2006, New England Journal of Medicine, reported that mothers who took SSRIs in the second half of their pregnancies were 6 times more likely to give birth to babies with PPHN.
The study found 14 infants with PPHN in the group who had been exposed to an SSRI, compared to 6 infants with the disorder in the group who were not exposed to the drugs.
The FDA found the study so alarming that it prompted the agency to hold a press conference. "This appears to be a very well-conducted study and we find the results to be very concerning, said Dr Sandra Kweder, deputy director of the office of new drugs at the FDA.
She also told reporters that women of reproductive age are the "biggest users of antidepressant drugs."
Instead of immediately taking action to warn doctors and consumers of this development, the pharmaceutical industry went into all-out damage control to protect SSRI profits by encouraging pregnant women to keep taking SSRIs.
A corresponding study in the February 2006, Journal of the American Medical Association, warned that pregnant women who stopped taking the drugs could greatly increase their risk of a relapse of depression. The authors of the study predicted that their findings would prompt some women to stay on SSRIs throughout pregnancy.
The JAMA study got much more media attention than Dr Chambers, and included headlines warning about the dangers of relapse in pregnant women going off SSRIs. Many local television news broadcasts even ran an unedited video provided by JAMA, featuring a study author and one of his patients.
However, 5 months later, on July 11, 2006, the Wall Street Journal published an expose on the researchers involved in the study who were encouraging pregnant women to keep taking SSRIs. "But the study," it reported, "and resulting television and newspaper reports of the research failed to note that most of the 13 authors are paid as consultants or lecturers by the makers of antidepressants."
Most of the authors, the WSJ noted, were leading psychiatrists at Massachusetts General Hospital, the University of California Los Angeles, and Emory University
The lead researcher, Dr Lee Cohen, a professor at Harvard Medical School, it reported, "is a longtime consultant to three antidepressant makers, a paid speaker for seven of them and has his research work funded by four drug makers."
Among the most significant of the missing financial disclosures, the Journal said, were those of study author, Lori Altshuler, director of the Mood Disorders Research Program at UCLA, who was a speaker or consultant for at least 5 antidepressant makers.
Vivien Burt and Victoria Hendrick were also authors who did not report financial relationships with SSRI makers, and Dr Viguera, another author, did not disclose her paid speaking relationship with Glaxo.
All total, the Journal said, "the authors failed to disclose more than 60 different financial relationships with drug companies."
"The work of these academic researchers, the article wrote, "highlights the role of "opinion" or "thought" leaders coveted by drug companies because of their ability to influence not only the practice of doctors, but popular opinion as well.
In the case of SSRI use by pregnant women, the WJS said, the industry-paid opinion leaders have become dominant authorities in the field and stated:
"They help establish clinical guidelines, sit on editorial boards of medical journals, advise government agencies evaluating antidepressants and teach courses on the subject to other doctors. In some cases, the financial ties between industry and these leading researchers are not disclosed.
According to the WSJ, as soon as their study was published, Dr Cohen and some the other authors went out on the lecture circuit, telling doctors about their findings and pointing out flaws in the studies that found an increased risks of birth defects with infants exposed to SSRIs.
For instance, the panel of experts who criticized the Chambers study during the May 17, 2006, continuing medical education lecture, "Psychotropic Drug Use During Pregnancy," sponsored by the Massachusetts General Hospital Psychiatry Academy, was comprised entirely of psychiatrists with financial ties to drug companies.
During the lecture, the panelists were also critical of the FDA for adding new warnings about birth defects to Paxil,s label. On December 8, 2005, the FDA issued a Public Health Advisory after US and Swedish studies showing that exposure to Paxil in the first trimester of pregnancy to be associated with an increased risk of heart birth defects.
With the warning, the agency for the first time placed an SSRI in the D category, its second highest for the risk of birth defects. Category D means that either controlled or observational studies of pregnant women "have demonstrated a risk to the fetus."
The agency did not ban Paxil from use with by pregnant women, but it did go so far as to say, "FDA is advising patients that this drug should usually not be taken during pregnancy."
At the May 17 conference, panelist, Zachary Stowe, from the women's mental health center at Emory University, described the FDA,s decision to change the label as "driven by a single set of data that is unpublished, non-peer reviewed, and somehow this trumps the very nicely done prospective investigations that have really failed to find this risk."
However, here once again, according to the WSJ, Dr Stowe has served as an paid adviser and speaker for several SSRI makers.
In July 2006, corresponding with the WSJ,s expose about the undisclosed financial relationships of the Cohen study authors with SSRI makers, JAMA published a correction to announce that 7 of the authors of the February 2006, study had failed to reveal their financial ties with drug companies.
Critics of Big Pharmas influence over studies published in medical journals were quick to respond to the disclosure. On July 11, 2006, Merrill Goozner, director of the Center for Science in the Public Interest, issued a statement saying: "It,s clear that the Journal of the American Medical Association does not evaluate conflict of interest disclosures when articles are submitted.
"As a result, Mr Goozner said, "some authors with blatant conflicts of interest apparently feel they can ignore the journal,s policy with impunity.
"The only solution, he added, "is for journals to adopt strong penalties for authors who fail to disclose a three-year ban from publishing in the pages in the journal.
A month later in August 2006, another study in the Archives of General Psychiatry, by Canadian researchers at the University of British Columbia, found babies born to women who took SSRIs during pregnancy to be at an increased risk of having respiratory distress and low birth weight.
Lead investigator, Dr Tim Oberlander, told Reuters Health on August 25, 2006, that "our study was undertaken to distinguish the effects of maternal mental illness -- pregnancy-related depression -- from its treatment -- SSRIs -- on neonatal outcomes."
The researcher reviewed health records for almost 120,000 live births between 1998 and 2001 and determined that 14% of the mothers were diagnosed with depression. They then compared the outcomes of infants born to women treated with SSRIs to those born to depressed women who were not treated with SSRIs and found a significantly higher incidence of respiratory distress in infants exposed to SSRIs by a ratio of 13.9% to 7.8%.
The study reported longer hospitalizations for infants born to mothers on SSRIs, and found birth weight and gestational age were also significantly less in SSRI exposed infants.
"These findings are contrary to an expectation that treating depressed mothers with SSRIs during pregnancy would be associated with lessening of the adverse neonatal consequences associated with maternal depression," Dr Oberlander told Reuters.
In October, 2006, the journal, Pediatrics, reported that CDC researchers cited preterm birth as the leading cause of infant mortality in the US, accounting for at least one-third of all infant deaths in 2002.
The contribution of prematurity to infant mortality may be twice as high as originally estimated, reported Dr William Callaghan, MD, MPH, and colleagues.
The research team looked at the top 20 causes of infant deaths in 2002, and found that 34% occurred in preterm infants, 95% of whom were born before 32 weeks gestational age of 32 weeks and weighed less than 3.3 pounds.
"The extreme prematurity of most of the infants and their short survival indicate that reducing infant mortality rates requires a comprehensive agenda to identify, to test, and to implement effective strategies for the prevention of preterm birth," the authors wrote in Pediatrics.
There are also studies showing infants born with symptoms of neurological damage associated with SSRI exposure in the womb. In February 2004 a study in the American Journal of Pediatrics reported abnormal sleeping patterns, heart rhythms and levels of alertness linked to SSRIs.
Dr Philip Zeskind, a developmental psychologist and research professor at the University of North Carolina, Chapel Hill, led the investigation and on February 22, 2006, told the Sunday Telegraph, "What we've found is that SSRIs disrupt the neurological systems of children, and that this is more than just a possibility, and we're talking about hundreds of thousands of babies being exposed to these drugs during pregnancy."
In reaching their results, the team of researchers compared 17 babies born to mothers who took the Prozac, Paxil, Zoloft or Celexa throughout their pregnancy, with 17 babies born to mothers who had never taken SSRIs.
According to Dr Zeskind, "These babies are bathed in serotonin during a key period of their development and we really don't know what it's doing to them or what the long-term effects might be."
"It could be that they go `cold turkey' when they are born, he explained in the Telegraph, "or the serotonin could be having an effect on their brains, or it could be a bit of both."
"We're not saying that pregnant women should not take the drugs, because depression is itself a big problem, he said. "But these drugs are being given away like smarties, and this is a big problem, Dr Zeskind warned.
Legal analysts predict that this first PPHN lawsuit is just the tip of the proverbial iceberg because there are tens of thousands of infants exposed to SSRIs in the womb each year.
After the results of her study were made public, Dr. Chambers says she heard from women all across the country who took SSRIs during pregnancy and had babies born with PPHN.
The fact that Glaxo has not ordered its hired-guns to stop promoting the sale of Paxil to pregnant women, proves that the company plans to go on sacrificing the lives of babies in the name of profits and that should be a fairly easy point to get across to a jury.
Families seeking justice for infants born with Paxil related birth defects can contact the Baum Hedlund Law Firm at: (800) 827-0087; http://www.baumhedlundlaw.com/
Evelyn Pringle is an investigative journalist. She can be reached at: email@example.com"
"Pope of ECT" HAROLD SACKEIM owns up at last that ECT causes brain damage
|December 1 2006, 9:21 PM |
A bit too late for all those people who suffered permanent brain damage due to Mr Sakeim's insistence on denying their damage over the last 25 years. Mr Sakeim is responsible for damage done to countless brains worldwide from ECT. He was the (only) one who procured NIMH research funding for the study of the adverse effects of ECT and it was given on a promise he would do so, but he chose not to keep that promise. In addition, the repulsive Mr Sakeim designs ECT machines for the industry that makes them and, just as applies to the pharma industry, your brain and your pain is his gain.
by Linda Andre
The Cognitive Effects of Electroconvulsive Therapy in Community Settings
NIMH-funded research study published in the January 2007 issue of Neuropsychopharmacology
Author and primary investigator: Harold Sackeim
Funding: NIMH grants
#35636, Affective and Cognitive Consequences of ECT, funded since 1981 for a total of approximately ten million dollars so far (grant has been renewed through 2009)
#59069, ECT Practices in Community Settings—Evaluating Outcomes, funded since 1999 for a total of approximately 3.5 million dollars so far
Summary: After 25 years and millions of dollars of federal funding to research the adverse cognitive effects of ECT—25 years in which not one single longterm followup study was ever published—self-proclaimed “world expert” on ECT Harold Sackeim has now reversed his position, admitting that ECT routinely causes permanent memory loss and deficits in cognitive abilities. His new study—the first to be published in which he followed patients as long as six months, and one of his only studies to use controls—validates a generation of patient reports of permanent iatrogenic disability, and disproves Sackeim’s previously published claims that these reports were simply symptoms of mental illness. Other findings: there is no evidence that ECT increases intelligence, as Sackeim has previously claimed; and women are much more likely than men to experience severe permanent amnesia.
Significance: Harold Sackeim has been called the Pope of ECT, and for good reason. He’s published more on ECT than anyone in the world, has received more money to research it than anyone in the world, and is the author of the American Psychiatric Association’s patient information statement and consent forms, which are used by most hospitals in America. Through his writing, teaching, testimony—and positions on peer review, editorial, and funding boards, including NIMH grant review panels—he has more influence on what the profession and the public believe about ECT than anyone in the world. What Harold says goes.
Conclusion: This study could have been done at any point in the past 25 years. If it had, a generation of patients could have been warned of the likelihood of permanent significant memory and cognitive deficits before, instead of finding out after, ECT. In fact, there is evidence—from Harold’s own statements—that over the years he has in fact conducted studies following up ECT patients for a long as five years…but never published the results. Why not? Why did it take 25 years and over ten million dollars to validate what patients have been saying all along? In other words: What did Harold know, when did he know it, and why wasn’t it revealed?
Quotable quote from the study: This study provides the first evidence in a large, prospective sample that the adverse cognitive effects can persist for an extended period, and that they characterize routine treatment with ECT in community settings.
For a detailed critique, see below.
For the past 25 years, patients who received electroconvulsive therapy (ECT) have been told by the nation’s top ECT doctor that the controversial treatment doesn’t cause permanent amnesia or cognitive deficits and, in fact, improves memory and increases intelligence. Psychologist Harold Sackeim of Columbia University also taught a generation of ECT practitioners around the world that permanent amnesia is so rare it could never be studied. Sackeim was the popularizer if not originator of the position that former patients who said the treatment erased memory were simply mentally ill and thus not credible.
His newest and perhaps last ECT research study disproves his tenaciously held claims about the treatment’s harmlessness. It is, in effect a stunning self-repudiation of a 25-year research career…one in which he accepted federal research money with one hand and consulting fees from shock machine companies with the other.
See, for instance, the key finding:
This study provides the first evidence in a large, prospective sample that the adverse cognitive effects can persist for an extended period, and that they characterize routine treatment with ECT in community settings.
Similarly, from the abstract:
Despite ongoing controversy, there has never been a large scale, prospective study of the cognitive effects of electroconvulsive therapy
Sounds like the research team is congratulating itself for being “the first,” as if they’d made a discovery before anyone else, doesn’t it? You might think that…if you didn’t know that Sackeim has held the only available NIMH research grant to study ECT’s adverse effects, titled “Affective and Cognitive Consequences of ECT,” continuously since 1981…
and if you didn’t know what Sackeim promised the federal government in his original application for grant funding:
“The major objective of the proposed research is to examine the effects of bilateral and right unilateral electroconvulsive therapy on affective and cognitive functioning. The consequences of the two treatment modes will be studied in regard to neuropsychological functions that have previously not been studied…Drug-free inpatients presenting major unipolar depressive disorder will be tested before, during and after treatment and a matched normal control group will be tested at comparably spaced times.”
Instead of doing this, however, he used his grant money largely to compare different types of ECT to each other, not to examine the effects of ECT; and only less than a handful of his 200+ published studies used normal controls, an absolute necessity to isolate the effects of ECT.
Why did it take 25 years to conduct one large, long-term controlled follow-up study? And in the absence on this research, why did Harold so confidently assure professionals, patients, legislators, and the public that ECT was safe?
A closer look at the study shows us that, in fact, Harold and his team are still not being honest with us, still not revealing all they know. They tried their damnedest not to find out what ECT really does…but failed. Here they reveal only the minimum information they had to concede after using every trick in the book to bias their research in favor of not finding negative effects of ECT.
What tricks did they use here?
1) The assumption that ECT does not cause permanent amnesia and cognitive deficits was built into the design of the study. How so? The study allowed subjects who’d had ECT before, as recently as two months prior, to be counted as the “before ECT” patients–meaning before this course of ECT. It assumed that any effects of ECT resolve within two months. 43% of the subjects had had prior ECT, so that at least half of the data involved comparing the effects of ECT to the effects of more ECT–not isolating the effects of ECT.
2) The outcome measures used to measure amnesia and cognitive function are irrelevant and inadequate to measure the known effects of ECT. Yet even deliberately using measures that would result in underestimating deficits, these deficits were still found to be profound and persistent!
For a critique of the tests used by Sackeim, see Robertson and Pryor’s article, Memory and cognitive effects of ECT: informing and assessing patients, in Advances in Psychiatric Treatment (2006), vol. 12, p. 228-238. For example, the Mini Mental Status exam used by Sackeim is a test that screens for dementia, the grossest and most glaring form of cognitive disability, and is useless for detecting the kinds of deficits caused by ECT.
Sackeim uses a memory test he invented himself, the Autobiographical Memory Inventory. This test is unpublished, not publicly available, not validated, and is not used except by ECT advocates. Robertson and Pryor note that the majority of questions are not relevant to the types of information forgotten by ECT survivors, nor can the test detect amnesia beyond a one-year period. A string of references in Sackeim’s new article attempt to provide support for the claim that the AMI “has shown strong reliability and validity as a measure of retrograde amnesia.” Not only do they not show this, but all the referenced articles were written by Sackeim himself!
3) Patient IQs were estimated pre-ECT using a method that underestimates intellectual ability especially with much higher than average IQs; no attempt was made to ascertain actual IQ. No one looked at these patients’ IQs post-shock to see what happened to them; why not?
Sackeim et al. conclude, based on inaccurate assumptions and no data from these or any other patients, that “Individuals with greater premorbid abilities can better compensate for the impact of ECT on cognitive functions” (references claiming to support this point have nothing to do with ECT but are articles about an unproven theory of “cognitive reserve”).
Even if the researchers didn’t choose to seek out survivors of ECT who once had very high IQs, or to respond to the many survivors of formerly superior IQs who have contacted them, there is a substantial record of accounts by persons who had extremely high or genius IQs who have spoken and written publicly of the devastating effects of having those IQs lowered by ECT (Jonathan Cott, Linda Andre, Anne Donahue, and Marilyn Rice are four such individuals.) None of these accounts suggests that people with “greater premorbid abilities” have an easier time after ECT; in fact, they strongly suggest the opposite.
In addition to these tricks, the researchers used one of the most reliable methods of biasing results: concealing data.
1) “A substantial number of secondary cognitive measures” are said to have been administered along with the named tests, yet the researchers nowhere reveal what they were and what the results were.
2) The names of the seven facilities in the New York City metropolitan area are not revealed. While this isn’t necessary for evaluating the results of the study, it means the facilities with the worst outcomes can’t be held publicly accountable, nor can the millions of city residents protect themselves from the worst offenders.
3) The results of the cognitive tests on the 24 control subjects are not revealed, nor is how they compared to the people who had ECT.
It’s a very big deal for the Sackeim team to use matched normal controls; in 25 years and hundreds of studies they have not done so. Normal controls are essential to ethical and valid research. This article states that “The comparison sample completed the same neuropsychological battery at time points corresponding to the assessment period in patients.” But you search in vain to find out how the controls did on the five named tests of memory and cognitive functioning and the unnamed “secondary measures”, and how they compared to the ECT patients immediately and six months after ECT. It’s not in the text, and it’s not in the tables. So why have the controls take the tests at all, if you’re not going to reveal the results?
Only one thing is revealed: The normal controls did much better than the bilateral ECT patients on the (flawed) measure of amnesia:
“The average decrement in AMI-SF scores in patients treated exclusively with BL ECT was 3.4 and 2.8 times the amount of forgetting seen in the healthy comparison groups at the post-ECT and 6-month time periods, respectively, suggesting that the deficits were substantial.”
4) Sackeim does not reveal—has never revealed in hundreds of published articles—his financial ties to the shock machine companies Mecta and Somatics. Yet in sworn testimony, Sackeim admits he has worked for Mecta for at least twenty years. He designs their shock machines for them. Not only is disclosure required by journals such as Neuropsychopharmacology (ironically, the subject of a recent scandal in which authors and even the journal’s editor did not reveal their ties to another company which has hired Sackeim, Cyberonics), it is also required by state law (because Sackeim is an employee of New York State) and federal law (because Sackeim accepts NIMH money).
Sackeim flaunts these laws by not disclosing the money he makes from the shock machine manufacturers.
This article is a damning critique of work done over 25 years (and at the expense of millions of taxpayer dollars) by this very team of researchers.
If you know that Sackeim’s been funded for decades to do this research and chose not to do it, the following statements read very differently than the researchers intended. Instead of self-congratulation, they read as condemnation.
“Empirical information about ECT’s long-term effects derives mainly from small sample studies conducted in research settings, with follow-up intervals limited to two months or less…These studies could not adequately assess the severity and persistence of long-term deficits.”
The use of small samples and short-term follow-up characterizes all of Sackeim’s work until now, and was their choice, deliberately made so as not to know (officially) about “the severity and persistence of long-term deficits.” These researchers single-handedly had the wherewithal to address these belatedly-acknowledged flaws in their own research at any time since 1981.
“We conducted the first large-scale, prospective study of cognitive outcomes following ECT.”
Why the first study only after 25 years? What of the generation of patients—two and a half million people according to their own estimate—who have received shock in those years without knowing the long-term consequences?
“Severity of depressive symptoms showed little relationship with the cognitive measures. At the post-ECT time point, none of the 11 measures were related to concurrent HRSD scores. Findings were also negative for 8 of the 11 measures at the six-month follow-up.”
Translation: patients aren’t just imagining or lying about their cognitive and memory deficits because they’re crazy. Yet in many published articles written on the NIMH dime, and over and over in public testimony and in court, that is exactly what Sackeim and Prudic have claimed. And they have influenced countless others to believe it.
DAMNING FINDING #1: amnesia is substantial and permanent
“The average decrement in AMI-SF scores in patients treated exclusively with BL ECT was 3.4 and 2.8 times the amount of forgetting seen in the healthy comparison groups at the post-ECT and 6-month time periods, respectively, suggesting that the deficits were substantial.”
“At the six-month time point, there continued to be a significant relationship between the number of BL ECT treatments and the extent of retrograde amnesia.”
“Greater amnesia for autobiographical events was significantly correlated with the number of ECT treatments received 6 months earlier.”
DAMNING FINDING #2: cognitive deficits are substantial and permanent
“Compared to baseline performance, at the postECT time point the total patient sample showed deficits in the mMMS, sensitivity of the CPT, delayed recall of the BSRT, delayed reproduction on the CFT…” (All are measures of memory and cognitive ability).
“This study provides the first evidence in a large, prospective sample that the adverse cognitive effects can persist for an extended period, and that they characterize routine treatment with ECT in community settings.”
DAMNING FINDING #3: ECT permanently affects reaction time
“Although psychomotor function is of practical importance with respect to driving and other motor activities, the impact of ECT on this domain has rarely been examined…”
(Once again: Whose fault is that?)
“The fact that relative reaction time deficits were observed at the 6-month follow-up indicates a persistent change in the speed of information processing, motor initiation, or response levels…The findings here raise the concern that this form of stimulation has deleterious long-term effects of elemental aspects of motor performance or information processing.”
DAMNING FINDING #4: Bilateral ECT is no good
“For decades, BL ECT represented the gold standard with respect to ECT efficacy…A majority (of US ECT practitioners) administer mainly or exclusively BL ECT…
There appears to be little justification for the continued first-line use of BL ECT in the treatment of major depression.”
(More than 90% of the ECT given in the U.S., and at least as high a proportion in other countries, is bilateral.)
DAMNING FINDING #5 They lied when they wrote in the APA consent form that ECT improves your memory
What this team has said in numerous published articles—and what Sackeim wrote into the American Psychiatric Association guidelines on ECT, the “bible” used by all rank and file shock doctors—that ECT improves memory and intelligence, is not true.
“It is noteworthy that most cognitive parameters were substantially improved at 6-month follow-up relative to pre-ECT baseline, presumably because of the negative impact of the depressed state on baseline performance…It cannot be concluded, however, that the extent of improvement in any group returned to premorbid levels.”
DAMNING FINDING #6: A much greater percentage of women than men are damaged by ECT than men: 81% vs. 18%.
“There was a gender difference, with a greater preponderance of women (81.6%) compared to men (18.4%) in the persistent deficit group.”
No doubt Sackeim and his handlers will try to “spin” this study as a scientific breakthrough, and hold him up as a reformer and patient advocate. Nothing could be farther from the truth.
Where is the apology to the generation of people who were lied to, who will never regain their memories and their cognitive abilities?
Added: Nov 24, 2006 3:24 pm | Trackback URI | Email This Article | Print
HAROLD SACKEIM LIED IN THE AMERICAN PSYCIATRIC ASSOCATION GUIDELINES
|December 1 2006, 9:30 PM |
From the article directly above this post:
"...The average decrement in AMI-SF scores in patients treated exclusively with BL ECT was 3.4 and 2.8 times the amount of forgetting seen in the healthy comparison groups at the post-ECT and 6-month time periods, respectively, suggesting that the deficits were substantial.”
What this team has said in numerous published articles—and what Sackeim wrote into the American Psychiatric Association guidelines on ECT, the “bible” used by all rank and file shock doctors—that ECT improves memory and intelligence, is not true..."
That kind of liar, one that does harm to hundreds of thousands of people should be in a criminal court.
NUREMBERG springs to mind.
Along with him all the many other liars that falsify negative drug trial data and submit instead 'clinical evidence' of safety.
FDA give WARNING to AstraZeneca over MISLEADING MATERIAL re SEROQUEL
|December 1 2006, 9:39 PM |
AstraZeneca given FDA warning over 'misleading' material
Last Update: 1:20 PM ET Nov 24, 2006
WASHINGTON (MarketWatch) -- AstraZeneca PLC (AZN) has been warned by the Food and Drug Administration that promotional material for its drug Seroquel is misleading and should no longer being distributed.
Seroquel is indicated for the treatment of acute manic episodes associated with bipolar disorder and for the treatment of schizophrenia.
According to the warning letter posted on the FDA Web site Wednesday, the sales material "minimizes the risk of hyperglycemia and diabetes mellitus and fails to communicate important information regarding neuroleptic malignant syndrome, tardive dyskinesia and the bolded cataracts precaution."
The drug's label says neuroleptic malignant syndrome, which can be fatal, has been reported in association with administration of antipsychotic drugs, including Seroquel.
The syndrome manifests as hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability, including irregular pulse or blood pressure, tachycardia and cardiac dysrhythmia.
The label also states that tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs.
The FDA requested that AstraZeneca stop disseminating the material, adding that the company has until Nov. 30 to respond to the warning.
A company representative wasn't immediately available to comment.
Seroquel had global sales of $2.8 billion last year.
American depositary shares of the U.K. pharmaceutical giant recently traded at $57.48, up 18 cents, or 0.3%.
AUSTRALIA: Studies show "Antidepressants NOT for cancer"
|December 1 2006, 9:48 PM |
Very similar results to studies on their efficacy in everyone else.
Anti-depressants not for cancer
November 30, 2006 12:00
ANTI-depressants taken by thousands of Australians with advanced cancer do nothing to improve quality of life, a world-first Australian study has concluded.
Cancer specialists say such drugs are effective for the quarter of advanced cancer patients that have full-blown clinical depression.
But they don't help the majority who are often prescribed them for relief from symptoms of depression, anxiety and fatigue, but no clinical diagnosis.
"Our findings suggest that if you've got these symptoms but not major depression you're better off doing something other than taking a pill,'' said specialist Martin Stockler, from the University of Sydney.
The surprise findings, presented today at a cancer congress in Melbourne, are drawn from a nationwide trial of 189 people in the late stages of cancer but without major depression.
Scientists used the common select serotonin re-uptake inhibitor (SSRI) Zoloft, known generically as sertraline, but they believe the results are applicable equally to other anti-depressants.
"Half the trial participants took sertraline...while the other half took a placebo that looked the same but had no sertraline in it,'' Prof Stockler said.
The team was disappointed to find little or no improvements in levels of depression, anxiety, fatigue, or well-being.
"Basically, benefits were minimal and insufficient to warrant its use,'' he said.
About 100,000 Australians die of cancer every year, with well over half falling into the category examined by researchers.
Their symptoms are troublesome but don't warrant a clinical diagnosis of depression or anti-depressant treatment.
However, these are widely prescribed anyway, by doctors keen to help ease their patients' burden.
Prof Stockler said the findings, presented to the annual scientific meeting of the Clinical Oncological Society of Australia (COSA), suggest such people should no longer be prescribed anti-depressants.
"Doctors give them out because they want to help, but they don't work,'' he said.
"We really ought to be looking instead at testing other interventions, like exercise, counselling, cognitive behavioural therapy and support groups ... That could be more promising.''
AMERICAN COLLEGE OF OBSTETRICIANS advise AVOID PAXIL IN PREGNANCY
|December 1 2006, 9:57 PM |
|Avoid Paxil in Pregnancy, ACOG Committee Advises
WASHINGTON, Nov. 30 -- The antidepressant Paxil (paroxetine) may cause fetal cardiac malformations, and the drug should be shunned if possible in pregnancy, recommended an advisory committee of the American College of Obstetricians and Gynecologists.
"At this time, paroxetine use among pregnant women and women planning pregnancy should be avoided, if possible," wrote members of the ACOG committee on obstetric practice in the December issue of Obstetrics & Gynecology
"Fetal echocardiography should be considered for women who were exposed to paroxetine in early pregnancy," they added. "Because abrupt discontinuation of paroxetine has been associated with withdrawal symptoms, discontinuation of this agent should occur according to the product's prescribing information."
Although several previous studies have failed to find a link between SSRI use in pregnancy and major congenital malformations, GlaxoSmithKline, the maker of Paxil, has revealed that unpublished reports from a U.S. insurance-claims database and a Swedish national registry have suggested a possible link between Paxil used in the first trimester and increased risk of atrial and ventricular septal defects, pointed out the committee.
An estimated 2% to 3% of women use Paxil or another selective serotonin reuptake inhibitor (SSRI) during pregnancy, the authors noted.
In the Swedish report, women who received Paxil in early pregnancy had about a twofold increased risk for having an infant with a cardiac defect compared to the entire national registry population.
In the U.S. study, children born to women who took Paxil in the first trimester had a 1.5-fold increased risk for cardiac malformations, and a 1.8-fold increased risk for congenital malformations overall compared with children of women who took other antidepressants, according to an FDA advisory issued in December 2005.
In both instances, the findings were restricted to Paxil, and not to other SSRIs.
The findings prompted a change in Paxil's labeling from Pregnancy Category C (drugs with a teratogenic effect in animal studies that have not been adequately studied in humans) to Category D (drugs that have been found to have harmful effects on human fetuses).
The committee members suggested that the decision to use or discontinue SSRIs during pregnancy is a difficult one, citing studies showing on the one hand that women who discontinued antidepressants during pregnancy had a fivefold greater risk for depression relapse than women who continued taking the drugs, and on the other hand a large case-control study that found a six-fold increase in the risk of persistent pulmonary hypertension for newborns whose mothers used SSRIs after 20 weeks of gestation.
"The potential risk of SSRI use throughout pregnancy must be considered in the context of the risk of relapse of depression if maintenance treatment is discontinued," they wrote. "Untreated depression may increase the risk of low weight gain, sexually transmitted diseases, and alcohol and substance abuse, all of which have maternal and fetal health implications."
The committee members recommended an individualized approach to treating pregnant women or women who are planning pregnancy with all SSRIs and/or selective norepinephrine reuptake inhibitors.
"Decisions about treatment of depression should incorporate the clinical expertise of the mental health clinician and obstetrician, and the process should actively engage the patient's values and perceptions when framing the discussion of the risks and benefits of treatment," the committee member wrote.
"Optimally, shared decision making among obstetric and mental health clinicians and women should occur before pregnancy. However, given that approximately 50% of pregnancies are not planned, preconception planning for women with depression will not always happen, and decisions regarding treatment with SSRIs will undoubtedly occur during gestation."