Tuesday, July 31, 2007
On the 18th June 2007 a meeting was held with the Seroxat Users Group and Lord Hunt. Minutes of the meeting have now been posted via the Seroxat Weblog page and I have attached them for your perusal.
Reading through it, it seems Lord Hunt has made many promises. Only time will tell if Hunt sticks to these promises.
A point of interest though is the fact that Hunt has said that the MHRA's investigation into GSK WILL be made public. Now call me cynical but what's the betting that much of the 'report' will be undisclosed because of some rule that the MHRA invent so the public cannot see the truth?
You may like to know that the Seroxat Sufferers site has now reached in excess of over 23,000 hits.
After almost of three years of asking you, I think it's about time you said something in the house about Seroxat, GSK and the MHRA don't you Gisela?
Mr Bob Fiddaman
GlaxoSmithKline (GSK) is sponsoring an educational program and Web site called the State of Diabetes Complications in America, which boasts as spokespeople former Dallas Cowboys running back Ron Springs and his son, Washington Redskins cornerback Shawn Springs. According to the campaign's Web site, about three out of five people with type 2 diabetes have at least one of the other serious health problems associated with the disease. The site includes maps of the United States showing diabetes prevalence and blood sugar levels in each state. There are also resources for patients, including a diabetes complications risk assessment tool and steps to take for better blood sugar control. Ron and Shawn Springs will appear in Dallas next week on behalf of the campaign to talk about Ron's experience with the disease, as the campaign presents new report findings.
Great eh? Manufacture a drug to help diabetes patients, sit back and deny there is any problems with said drug once reports filter in about patients suffering heart attacks on drug. Then the creme de la creme - Hire a well known face to say how great GSK are.
You ever heard the Carly Simon song Glaxo?
You bunch of half assed fuckwits!
July 30th, 2007
A striking young woman with a talent for painting, Sharise Gatchell was - like many teenagers - painfully self-conscious. At 14, she moved with her family from South Africa to England where at first she found it hard to make friends. By the age of 16 she was acutely embarrassed that her periods hadn't started and felt she was sweating excessively. Just the sort of thing to make adolescence even more painful than usual. Her mother, Stephanie, took her to see a consultant physician at the local hospital. Stephanie Gatchell recalls:
"During that consultation she became a bit emotional because she was explaining to him about the problems she had and how it affected her social life. Then she started crying and I was amazed. He asked her, 'Sharise, do you sometimes feel like ending it all?', and I couldn't believe it when she said 'Yes I do.' And then he started talking about paroxetine and suggesting that she try it."
Paroxetine - better known as Paxil in the U.S. - is an antidepressant. It is licensed only for adults, but doctors are allowed to prescribe any medicine if they think it will help their patient, a practice called "off-label" prescribing. Sharise was not the only teenager getting paroxetine off-label. Around 7,000 children a year were on the drug in the UK; and many more in the U.S.
Within days of starting on paroxetine, Stephanie noticed a dramatic change in her daughter: she became more confident. But with the confidence came aggression and worse:
"One day in the kitchen her sleeve pulled up slightly and I noticed that there were cut marks on her left arm. I couldn't believe my eyes. She was obviously self-harming while she was on the drug, something she's never ever done before."
Stephanie persuaded her daughter to stop taking paroxetine. But in 2003 Sharise went back on it without telling her mother. When her parents returned from a weekend break, Stephanie immediately realized something was terribly wrong:
"I went upstairs before my husband came in, and the moment I got to the landing at the top and I turned round and looked, she was hanging from the loft hatch. I tried to revive her, but before I even started I realized I was too late."
Next to her daughter's suicide note lay a packet of paroxetine. Stephanie instinctively blamed the drug and now blames herself for letting her daughter take it. But she couldn't have known what the drug's manufacturer had known for years.
GlaxoSmithKline Experiments on Children
UK-based GlaxoSmithKline (GSK), the second largest drug company in the world, which recorded 2006 sales of over $45 billion, had begun a series of clinical trials in the mid-1990s to test whether paroxetine would work in depressed children. Paroxetine had already been hailed as a wonder drug in adults as a treatment for everything from depression and stress to anxiety and even shyness. By the new millennium 100 million paroxetine prescriptions had been written worldwide, bringing in $2 billion a year for GSK and placing the antidepressant a close second to Prozac in popularity.
With the adult market sewn up, the company sought new ways to make money from the drug, or "life cycle management," as the approach is known in the pharmaceutical industry. The U.S. Food and Drug Administration wanted to boost the number of medicines tested for children and had introduced an incentive that would give companies a six-month extension on their patent just for carrying out pediatric trials. For paroxetine alone that would be worth $1 billion. And if GSK could be the first company to prove its antidepressant was safe and effective for children, the rewards would be even higher, as paroxetine could become the market leader.
Hundreds of children were recruited from around the world to take part in three clinical trials. One group was given the drug, the other a placebo. They were randomized controlled trials (RCT) where neither the children nor their doctors knew whether they were taking the active drug or the placebo until the end of the study. This is widely accepted as the best way of working out whether a drug causes a particular effect: the gold standard in terms of evidence.
But the outcome of these the trials was not what GSK had been hoping for. Paroxetine proved no better than placebo. In the biggest trial, Study 329, which was conducted across several sites in the U.S., 11 of the 93 children who took paroxetine developed serious side-effects; seven had to be hospitalized. Significantly more had self-harmed or attempted suicide on the drug than on placebo.
The BBC (British Broadcasting Corporation) obtained confidential case reports from Study 329 which detail what happened to them:
"[13 days after starting paroxetine] the patient became very angry. He punched pictures, broke glass and sustained lacerations that required six sutures... he expressed hopelessness and possible suicide thoughts."
"The patient began exhibiting symptoms of disinhibition, grandiosity and expansive mood around week four [after eight weeks] the patient became agitated and said she would kill herself."
"[11 days after starting paroxetine] the patient was hospitalized for psychosis with auditory hallucinations and superficial cuts."
Yet this was a drug that was supposed to make children happier and reduce the risk of suicide.
The company knew it had a problem. In an internal memo to senior executives in 1998 the product director for paroxetine admitted:
"The results of the studies were disappointing. The possibility of obtaining a safety statement from this data was considered but rejected. Consultation of the marketing teams confirmed that this would be unacceptable commercially."
In other words, publishing the data in full would undermine the drug's safety profile and put profits at risk. It took five years for this information to reach the public domain and only then as a result of the BBC investigation. In the intervening years doctors continued to prescribe a drug to tens of thousands of vulnerable children, ignorant of the fact that it had not been shown to work and was harmful to some.
Lawsuits Reveal Questionable Paper Trail
This has been described by British psychiatrist Dr. David Healy as "the biggest medical scandal since thalidomide." Dr. Healy, rather than the regulatory authorities charged with monitoring the safety of medicines, was instrumental in uncovering the evidence at the heart of the scandal. It was a series of U.S. legal actions that led Dr. Healy, as an expert witness, and the legal team with whom he was working, deep into GSK's secret archives, where they found a series of damning internal documents.
What this paper trail reveals is how the company, with no hope of obtaining a children's license, devised a back-door method of marketing paroxetine for childhood depression. In came the spin-doctors to bury the inconvenient facts and spread the good news to doctors around the world that paroxetine was safe and effective for children.
Drug companies discovered long ago that doctors are much more likely to be persuaded by their peers than by the hard sell of sales reps. So GSK built a business relationship with several leading academics to write articles and speak at conferences, effectively selling paroxetine for the company. They are known in the trade as "Key Opinion Leaders."
Internal company documents reveal that Professor Martin Keller, Chair of Psychiatry at Brown University in the U.S., was one of the company's leading Key Opinion Leaders. He was named as the author of Study 329. But the documents cast doubt on whether he actually analyzed the data himself and wrote the final paper. In a memo, Professor Keller thanks a ghost writer for the initial preparation of the study manuscript - a ghost writer who works for a medical public relations company hired by GSK:
"You did a superb job with this. Thank you very much. It is excellent. Enclosed are some rather minor changes from me."
It is clear from the internal correspondence that the ghost writer was making some important decisions about how to present the data for publication. At one point a senior GSK executive comments that: "It seems incongruous that we state that paroxetine is safe yet report so many Serious Adverse Events."
GSK suggests to the public relations person that she make clear paroxetine may have caused all 11 of the serious side-effects. But the final article says: "Of the 11 patients, only headache (1 patient) was considered to be related to the treatment."
The paper never states clearly how many children became suicidal, nor does it explore whether the drug was to blame. Instead, it concludes that paroxetine is "generally well-tolerated and effective".
The next step in GSK's marketing plan was to get the study published. Doctors rely on medical journals to give them advice they can trust. The first journal GSK approached spotted flaws in the study and rejected it. So the company sent it to the premier children's mental health magazine, the Journal of the American Academy of Child and Adolescent Psychiatry. Its peer reviewers also spotted the flaws, as is clear from their confidential comments:
"Overall. Results do not clearly indicate efficacy, authors need to clearly note this."
"The relatively high rate of serious adverse effects was not addressed in the discussion."
"Given the high placebo response rate, are [these drugs] an acceptable first-line therapy for depressed teenagers?"
Nevertheless, the journal published the study. Who knows how many child and adolescent psychiatrists around the world were influenced by the article's misleading conclusion?
At the same time, another of GSK's PR people was saying in an internal memo:
"Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results. Essentially the study did not really show paroxetine was effective in treating adolescent depression, which is not something we want to publicize."
Objective Medical Opinion?
When I first started looking at Study 329 for the BBC in 2002, I was confused about its findings. The published article's conclusions seemed at odds with the details of the study. I went to Philadelphia to interview one of the authors and came across another of GSK's Key Opinion Leaders - Dr. Neil Ryan, an eminent child psychiatrist at the University of Pittsburgh. He was speaking at an American Psychiatric Association symposium sponsored by GSK but I had no reason at that time to think he was anything other than independent.
Dr. Ryan told the audience that paroxetine was effective for children with depression. He didn't mention anything about the apparent high rate of psychiatric side-effects of paroxetine in Study 329. But the more I studied the data, the more convinced I became that paroxetine was causing serious problems for some kids who took it. When I returned to Britain, I pursued him by telephone but he refused to talk to me about it.
Fast forward four years, when the internal GSK documents revealed what had actually been going on behind the scenes. Dr. Ryan had been asking the company that sponsored his research how he should deal with my awkward questions, emailing all my correspondence to them. In one email he said:
"I'll call you again later today and you can advise on how might be best to handle this."
GSK denies that it promoted paroxetine for off-label use through Key Opinion Leaders or any other route, laying the responsibility firmly at the door of individual clinicians.
A statement issued by the company reads: "Any decision to prescribe a medicine outside its authorized indications, in the EU or the U.S., is made by a doctor on the basis of his/her clinical judgement and the interests of their patient."
But where do doctors get the information from that gives them the confidence to prescribe off-label? From medical journals and conferences.
It was the documents that in the end exposed the Key Opinion Leaders and the drug company. Without the U.S. legal action we would have been none the wiser. The drug is now effectively banned in the UK for use in under-18s and in the U.S. it carries a "black box" warning about the risk of suicidal behaviour.
This drug was GSK's golden egg for many years and a lucrative business was built around its promotion. So it is perhaps not surprising the company dismissed my investigation as media scaremongering. What is surprising, though, is how many doctors on both sides of the Atlantic who claim to practice evidence-based medicine still refuse to acknowledge the damage the drugs can do - even though the evidence comes from GSK's own RCTs and the company's internal correspondence clearly shows how they tried to cover it up.
Sales Affected by Warning Labels
Dr. Mike Shooter, former President of the Royal College of Psychiatrists and a child psychiatrist who used to prescribe paroxetine, says:
"I personally felt cheated and heaven only knows what the children, adolescents and their parents and their doctors on the other end of that felt. Very much the same. This has huge implications, right through medicine."
Professor Keller and Dr. Ryan seem unabashed by their role in the scandal. A few months ago Professor Keller co-authored another paper, on the impact of media reporting on prescribing. Rather than exploring how those conducting the trials overlooked the damage to children caused by the drug, he and his co-authors expressed concern that prescriptions of antidepressants to children have declined sharply in the U.S. since the addition of the black box warning - as if the increased risk of suicidal behaviour on the drugs wasn't something that should affect prescribing.
The FDA is now considering whether to remove the black box warning on paroxetine and other similar antidepressants because it is scaring doctors. In the UK, the regulatory authorities are investigating whether GSK acted fraudulently in its conduct over Study 329. Theoretically, criminal charges could be brought, but the medicine's regulator is fully-funded by the drugs industry, so don't hold your breath.
Meanwhile, Stephanie Gatchell and her husband have moved away from the home that holds so many awful memories, to start a new life in Ireland. They can't forgive GlaxoSmithKline for concealing what it knew about paroxetine:
"I can't understand how they could possibly be so devious, and all just because of profit. I think the decision-makers in that company should be brought to justice. They have a lot to explain."
*Shelley Jofre is a reporter with BBC TV's flagship current affairs program: Panorama. To learn more about Sharise Gatchell, see http://www.gevil.netopti.net/.
GlaxoSmithKline issued a statement in response to Shelley Jofre's investigation.
WATCH SHELLY JOFRE'S POWERFUL INVESTIGATION
Video 'Secret Emails' kicks in around the 2.50 mark.
GAITHERSBURG, Md, July 30 —A federal drug advisory committee voted 20 to 3 late this afternoon that Avandia, a controversial diabetes drug made by GlaxoSmithKline, raises the risks of heart attacks, but it then voted 22 to 1 that it should nonetheless remain on the market.
How fucking absurd!
Source: Fiddy News (Fictional)
BIRMINGHAM, Wm, July 31 - Benz Baked Beans , which are consumed my millions of consumers was today found that their product raises the risk of heart attacks. However, the federal drug advisory committee voted that it should remain on the market
Same thing and the FDA know it.
I wonder if those on the FDA who have shares in GSK will review the situation regarding Avandia once they have sold their shares?
Monday, July 30, 2007
GAITHERSBURG, Md. -- - Avandia should be pulled from the market, a high-profile drug safety reviewer from the Food and Drug Administration testified today.
Dr. David Graham, who has been a critic of his own agency's handling of drug safety imbroglios in the past, believes the controversial diabetes pill should be removed from the market, in a presentation this morning before expert panels advising the FDA.
"(Avandia) increases the risk of cardiovascular risk compared to its non-use," he said. "A wrong decision will cost thousands of lives."
In his testimony, Graham said 70 percent of all diabetes patients eventually die of heart disease so any drug that raises that risk is "unacceptable."
What GSK Say - HERE
One post in particular made me sit up.
It's powerful and aimed at GSK's drugs reps (scum in my books)
I've corrected the spelling mistakes for convenience.
Here it is:
Have U GSK Reps NO HUMAN QUALITIES?
Does Money Blind you so to the reality of what your corporation gets away with?
Avandia - Heart Attacks
Paxil - Suicide and Homicide
Myodil - Crippling nerve damage
Ribena - Lies and false advertising
Inhuman testing methods on orphans without consent!
Overpricing AIDS Drugs!
Illegal off label practices
The list goes on and on!
Of course You want to believe that you make miracle drugs and that you are helping people! Well tell me what drugs GSK make that actually save lives? What lives do you save to counter act the ones you take away? GSK makes primarily consumer crap like toothpaste and lucozade !!!
You can fool yourself into thinking what you like but the truth is GSK Make crap and harmful drugs!And being a drug rep ,you have been used as a pawn in a money making machine! That's the reality! Wake up to it!!!
Your conscience will catch up with you some day!
And if it doesn't then KARMA will!!!
Wake UP !!!
Have You no conscience????
GSK could possibly be responsible for the deaths and injuries of hundreds of thousands if not millions of people! WAKE UP !
SSRI Makers Use Media To Reel In Pregnant Women as Customers
By Evelyn Pringle
Big Pharma's regular use of the media as paid shills, masquerading as caring doctors while feeding the public misinformation about the risks of prescription drugs, is disturbing, to say the least. However, when the goal is to increase profits through the sale of drugs to pregnant women that are known to be harmful to the fetus, the media's participation is downright despicable.
Since June 27, 2007, nearly every major news outlet in the US has broadcast the story that two new studies published in the New England Journal of Medicine found a low risk of birth defects in babies born to women who took selective serotonin reuptake inhibitor antidepressants (SSRI's) during pregnancy.
SSRI's include Paxil by GlaxoSmithKline; Zoloft marketed by Pfizer; Prozac by Eli Lilly; Celexa and Lexapro from Forest Laboratories; Luvox by Solvay, and generic SSRI makers Barr Pharmaceuticals, Ranbaxy Labs and Genpharm.
On June 27, 2007, the headline that appeared in countless news outlets that run articles from the Associated Press stated: "Antidepressants Not Risky for Defects."
ABC News reported on June 29, 2007, "Antidepressants Safer Than Believed During Pregnancy,"
"Antidepressants not linked to birth defects," stated the internet headline for News-Medical.net, on July 5, 2007.
These headlines outraged experts knowledgeable about the true risks of birth defects, but none drew more outrage than the headline in a press release put out by the US Centers for Disease Control the day before the story broke which stated: “New Study Finds Few Risks of Birth Defects from Antidepressant Use During Pregnancy.”
"The reassuring attitude promoted in the CDC's press release flew in the face of evidence linking SSRI exposure during pregnancy to increased birth defects, and the additional evidence of SSRI toxicity in the developing brain," says Dr Peter Breggin, author of The Antidepressant Fact Book and an expert on SSRIs.
"Women and their doctors who only catch the headlines created by these studies are being grossly misled," he advises. "SSRI's should never be used during pregnancy."
Dr Breggin notes that the CDC instructs pregnant women to speak to their doctors about the risks and benefits of taking SSRI's, but says, "doctors will have read the headlines inspired by the CDC and imagine there is little risk."
The paper, "Exposure to SSRI Antidepressants In Utero Causes Birth Defects, Neonatal Withdrawal Symptoms and Brain Damage," by Dr Breggin and Ginger Breggin, will be published in the upcoming issue of the Ethical Human Psychology and Psychiatry journal to refute the findings of the NEJM studies.
CDC Report and Media Coverage Misleading
The CDC claims the use of SSRI's during pregnancy is justified on the basis that depression has its own hazards. "But these hazards," Dr Breggin states, "pale in comparison to the upheaval that will befall new mothers, fathers and the extended families of the children who are born with profound birth defects."
In addition to disputing the claim that birth defects are rare, experts say the headlines are deceptive because: (1) the studies referred to were limited to women taking SSRI's in the first 3 months of pregnancy; (2) some birth defects develop later in pregnancy; (3) stopping the drugs at the end of 3 months, or at any time, can result in a serious withdrawal syndrome; (4) infants experience a withdrawal syndrome after birth, and (5) the headlines do not mention all the other adverse effects associated with SSRI's.
The headlines dilute the findings of the many studies that have shown serious withdrawal symptoms in newborns exposed to SSRI's, including high-pitched or weak crying, tremors, irritability, convulsions, poor muscle tone, abnormal sleep patterns, feeding difficulties, rapid breathing and respiratory distress, and increased admissions to intensive care units.
In discussing a 2004 study published in the Pediatrics journal, lead author Dr Philip Zeskind was quoted in the February 22, 2004, Sunday Telegraph as stating: "What we've found is that SSRI's 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."
"These babies are bathed in serotonin," he said, "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."
Experts say the headlines are also misleading because they infer that no birth defects were found in the studies when, in fact, the CDC study further confirmed associations between SSRI use and the occurrence of craniosynostosis and omphalocele, as well as certain types of heart defects.
The study also found anencephaly, babies born without a forebrain, to be 2.4 times greater in women taking an SSRI in the first trimester. "This is a catastrophic fatal birth defect that is not correctable," Dr Breggin points out. In babies born with anencephaly, much of the brain does not develop, and the babies are either stillborn or die shortly after birth, according to the National Institute of Child Health and Human Development.
Babies born with omphalocele, an abnormality in which the infant's intestine or other abdominal organs protrude from the navel, were 2.8 times higher in women taking SSRI's.
The severity of this condition varies, but can be life-threatening and usually requires surgery as well as weeks to years of adapting.
Craniosynostosis, a condition in which connections among skull bones close prematurely, was 2.5 times more prevalent. "A 2.8 times greater occurrence of this condition," Dr Breggin explains, "will cause 2,305 more US babies to be born each year with this birth defect as a result of their mothers taking SSRI's in the first trimester of pregnancy."
In September 2005, Glaxo sent out a "Dear Doctor" regarding a label change based on a recent study wherein women who took an SSRI were more likely to have an infant with omphalocele, in addition to craniosynostosis.
The CDC study also found that babies exposed to Zoloft had twice the risk of having a heart defect and 3 times the risk with Paxil. In October 2006, the journal, Epidemiology, reported that babies born to women who took SSRI's during the second or third month of pregnancy had nearly 2 times the risk of having congenital malformations, with the most common being cardiovascular in 29%, muscle and bone malformations in 31% and 14% had digestive malformations.
According to SSRI expert, Dr Grace Jackson, "It was already known in the 1980's and 1990's that the administration of SSRI's to embryonic cultures of rats and mice leads to craniofacial and cardiac defects."
The NEJM studies also showed an increased risk of neural tube defects, which are birth defects of the brain and spinal cord, with the two most common being spina bifida and anencephaly.
With spina bifida, the fetal spinal column does not close completely during the first month of pregnancy, and there is usually nerve damage that causes at least some paralysis of the legs.
A recent study conducted by the Institute of Reproductive Toxicology at the University of Ulm, Germany, and the new NEJM article noted that some women who took SSRI's throughout pregnancy had infants born with a club foot, where the foot is turned in, stiff and cannot be brought to a normal position. According to the NEJM, women who took Paxil during pregnancy were at a 5.8% increase of having a child born with this defect.
The NEJM articles also suggest that there is an association between SSRI's and anal atresia, a malformation in which the normal perforation or opening for the anus is absent where the end of the intestinal tract has not perforated the skin in the perineal area.
Industry Influenced Media
The industry's control over the mainstream media, evidenced by the broadcast of the NEJM studies, did not happen overnight. It began in the late 1990's when drug companies were granted permission to advertise their products to the public.
Over the last decade, the drug companies have intentionally poured so much money into advertising that the overall operating budgets of the major media outlets and television networks are now highly dependent on the pharmaceutical industry.
In addition to advertising dollars, Big Pharma has mastered the art of using the media to promote the sale of drugs and downplay their risks. Stories featured as health care news, based on rigged studies carefully planted in medical journals are promoted through reports written by PR firms and sent out to all the major media outlets in press releases.
A 2005 report by the UK Parliament found that 75% of clinical trials published in the major journals, including The Lancet, New England Journal of Medicine and the Journal of the American Medical Association, were funded by the drug industry.
Experts say medical professionals can no longer rely on what they read. "The sources of knowledge that doctors have been trained to trust have been taken over by the medical marketing community," says Dr John Abramson, author of the book Overdosed America.
Each year, the Prescription Access Litigation Project announces the "Bitter Pill Awards" to expose Big Pharma's efforts to manipulate consumers through the media. For the year 2004, the group granted, "The Cure for the Human Condition Award," to Paxil maker Glaxo, "For Hawking Pills to Treat the Trials of Everyday Life."
In support of the award, PAL cited an FDA warning letter sent to Glaxo about false advertising in a Paxil TV ad, saying it wrongfully “suggests that anyone experiencing anxiety, fear, or self-consciousness in social or work situations is an appropriate candidate for Paxil CR,” when these are simply not approved uses of the drug, PAL noted.
For 2007, the Bitter Pill Award could to go to CNN for granting the most airtime to industry-paid front men to downplay the risk of birth defects, with special thanks to Dr Sanjay Gupta.
After hearing Dr Gupta say the use of SSRI's was ok for nursing mothers on CNN on June 12, 2007, without discussing any of the risks of drugs, Larry Bone, an avid advocate for protecting the unborn child from the birth defects linked to SSRI's, wrote this author to state that the use of the TV news segments in recent weeks to promote the sale of these drugs to pregnant women and nursing mothers was "horrifying" and must be stopped.
"The public has a right to be honestly informed about the dangers of SSRI's," he wrote, "and the media has an ethical responsibility to see that pregnant women and nursing mothers are adequately informed about the dangers of these drugs."
"At the very least," he says, "media companies should carry disclaimers at the end of such news segment stating that SSRI's all carry warnings on their labels that the public should read."
The Reported Risks
Experts say it's a crapshoot prescribing these drugs to nursing mothers. "No one yet knows what effects SSRI's may have on nursing infants," Dr Jackson warns, "because no one has studied the long term consequences of administering SSRI's to infants via breast milk."
Furthermore, she adds, no one understands how the in utero exposure to SSRI's changes the wiring of the newborn's brain and, "it has never been proven that there is no effect of giving infants these drugs during the first months or years of post-uterine existence."
Researchers from Columbia University published a study in the October 2004 journal Science, suggesting that exposure to Prozac in the womb and in early childhood may permanently alter the brain's circuitry and disrupt neural development, leading to serious emotional disorders later in life.
The warnings that Mr Bone says viewers should be instructed to read are many. On December 8, 2005, the FDA issued a Public Health Advisory and a press release to announce that the agency was asking Glaxo to change the pregnancy category from C to D, a stronger warning which means, "studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus."
The Advisory said that the FDA "has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations."
The FDA also said that physicians who are caring for women receiving Paxil should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy.
On July 19, 2006, the FDA issued another Advisory after a study lead by Dr Christina Chambers in the February 9, 2006, New England Journal of Medicine, reported a 6-fold increased risk of the life-threatening lung disorder, persistent pulmonary hypertension, in babies born to mothers taking SSRI's and said, "the FDA has asked the sponsors of all SSRI's to change prescribing information to describe the potential risk for PPHN."
According to the FDA Advisory: "Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies. Babies with PPHN can be very sick and may die."
The risk of PPHN was first found by Dr Chambers in a 1996 study where the researchers found 2 cases of PPHN, an unexpected finding since there were relatively few women in the study and both women had taken Prozac late in their pregnancies.
Warnings about the adverse effects of SSRI's in the patient information sheet on the FDA's web site as of July 13, 2007, states: "babies delivered to mothers taking Paxil late in pregnancy have developed problems, such as difficulty breathing and feeding."
"Babies delivered to mothers taking Paxil early in pregnancy are sometimes born with heart problems," it states.
The Web Site Also Warns:
"Persons taking Paxil may be more likely to think about killing themselves or actually try to do so, especially when Paxil is first started or the dose is changed."
"Paxil may cause bleeding problems," the FDA warns, "especially if taken with aspirin, NSAID's (nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen) or other drugs that affect bleeding."
The information sheet also advises that Paxil patients, "may become hyperactive, excitable or elated," and, "have problems with impotence (erectile dysfunction), abnormal ejaculation, difficulty reaching orgasm, or decreased libido (sexual desire)."
Other side effects currently listed include weakness, dry mouth, constipation, yawning, infection, diarrhea, sweating, dizziness, tremor, nervousness, nausea, difficulty sleeping, decreased appetite and sleepiness.
According to Mr Bone, CNN is not the only guilty provider of misleading information about SSRI's. "Major broadcasting companies like CBS, FOX, ABC and NBC," he says, "are no longer worthy of trust when they shamelessly promote a class psychotropic drugs that threaten the public safety."
"Such promotion," he states, "constitutes a flagrant breach of basic television broadcasting ethics and fairness standards each and every time."
Mr Bone also says that the media should acknowledge whether the doctors featured in these segments have received grants or gratuity payments from SSRI's makers.
Risks Versus Benefits
Finally, experts point out that the headlines fail to disclose that SSRI's are ineffective. Clinical psychologist Dr Bruce Levine, author of a new book due out this fall entitled, "Surviving America's Depression Epidemic: How to Find Morale, Energy, and Community in a World Gone Crazy," says, "legitimate science shows that these antidepressants are no more helpful for depression than a placebo or no treatment at all."
"Even the dice-loaded drug company studies show that antidepressants are, in a scientific sense, a failure," he notes.
"For example," Dr Levine points out, "in 2002 the journal Prevention & Treatment analyzed 47 studies that had been sponsored by drug companies on Prozac, Paxil, Zoloft, Effexor, Celexa, and Serzone, and it reported that in the majority of the trials, the antidepressant failed to outperform a sugar pill placebo."
Another of the world's leading authorities on SSRI's, Dr David Healy, also says that the effectiveness of SSRI's has been exaggerated, and the actual data reveals that only one in 10 patients on SSRI's can be shown to respond specifically to the drug rather than a nonspecific factor or a placebo.
Dr Healy is the author of numerous books on psychiatric drugs including, "The Antidepressant Era" and "The Creation of Psychopharmacology."
He says that, in prescribing SSRI's to pregnant women, he is concerned about "the benefit-harm trade-off," because "without any benefits, the child runs all the risks including the neonatal withdrawal syndrome and birth defects."
Dr Healy points out that the CDC study focuses on linking particular specific defects to particular drugs, and once you do this, "you end up with very small numbers in each group and not a lot of significant findings," he says.
Evelyn Pringle is a regular columnist for YubaNet and investigative journalist focused on exposing corruption in government and corporate America.
All eyes are on the US Food and Drug Administration advisory panel meeting later today which will go some way to determining the future of Avandia but in the meantime, GlaxoSmithKline has signed a deal worth over $1.5 billion with the USA’s Targacept which will develop drugs for central nervous system disorders....
GSK’s shares, meanwhile, fell again ahead of the FDA committee meeting today which will discuss the thiazolidinedione class of antidiabetic drugs, and Avandia (rosiglitazone) in particular, as briefing documents from agency staff raised questions over the conflicting data relating to cardiovascular events.
sErOxAtMaDHas your wonder medication seroxat turned you seroxatmad? If so this site is for you!
So says the blurb at the head of the site HERE
A rather interesting post caught my attention:
I want my old life back, thanks very much. I bought your product, and by its addictive qualities you are forcing me to continue to buy it, and I dont like it anymore. Specifically, I want you to
Stop my crashing depression
Stop my head zaps
Stop me feeling totally spaced out all the time
Stop me getting short tempered with my kids who do nothing wrong except be kids
Allow me to return to work and regain some professional respect and integrity
Allow me to concentrate on more than one task at a time
Allow me to return to my normal weight and stop me looking like ive shoved a cushion down my shirt
Allow me to spend time with large groups of people without being convulsed with fear
Its not too much to ask is it?
I don't want any nonsense about a 'gradual improvement' either. I dont want to work at feeling better. I dont want to stuff my face full of magnesium citrate, vitamin B, fruit and vegetables, fish oil tablets or stugeron. I don't want to have to hang around in saunas, steam rooms, flotation tanks or new age hippy remedy treatment centres that do no bloody good.
I would also like a refund of the approximately £800 i have spent on your 'medicine' over the last 10 years, which has made me MORE ILL.
Male, Married with 3 great kids including a new baby who all tire me out! Seroxat 20mg for 11 years. Always struggled to come off. Now attempting for the 3rd time by coming off very slowly at 1mg per 2 months, although thinking of speeding up to 1mg per month. I'm now on 10mg and will be completely weaned off by 2008/9!- Also supplementing with fish oil and vitamin B
Kinda sums it up up eh?
There are many more posts from sufferers HERE
Sunday, July 29, 2007
It's a blog by Steve Poceta, a sleep expert.
The particular post I found rather interesting and (confusing) was about Restless Legs Syndrome. Interesting because I suffered with RLS whilst taking Seroxat. Confusing because Steve Poceta applauds GSK for sponsoring the first large multi-center trials in RLS but cynically adds '...ultimately resulting in the FDA indication and thus the ability to market and advertise their drug.'
It's a decent piece of bloggery, though unlike Steve Poceta I cannot applaud any trial GSK sponsor. They only do it to push whatever pill they manufacture that will combat the disease they sponsor.
Anyway, make of it what you will. You can see his musings here
Reading through it, it seems Lord Hunt has made many promises. Only time will tell if Hunt sticks to these promises.
A point of interest though is the fact that Hunt has said that the MHRA's investigation into GSK WILL be made public. Now call me cynical but what's the betting that much of the 'report' will be undisclosed because of some rule that the MHRA invent so the public cannot see the truth?
Friday, July 27, 2007
Thursday, July 26, 2007
Source: The Telegraph
One third of deaths in hospital investigated by a patient safety watchdog could have been avoided, claims a report released today.
The National Patient Safety Agency looked into 1,804 fatal hospital incidents reported to it in 2005. It found that 576 were "potentially avoidable" if there had been better communication between staff, faster recognition of the patient's deteriorating state, improved training and more accurate interpretation of test results.
Some 425 of the deaths investigated by the NPSA in 2005 were in acute or general hospitals. Of these, 71 were reported to be related to diagnostic errors, in 64 cases the patient's deteriorating condition was not recognised or not acted upon, and 43 involved a problem with resuscitation after cardiac arrest.
The remainder were connected to medication errors, suicide or still-birth.
Go take a look at the 'It's Quite An Experience' blog to read some rather interesting correspondence between its author and the MHRA and other rather dubious organisations.
It's a blog that I shall certainly be keeping my eye on
DRUGS USED AS CHILDREN`S COSH, CLAIM
A PSYCHIATRIC watchdog has highlighted the Island having the biggest increase in the country of doctors prescribing so-called kiddie coke for children’s attention deficit hyperactivity disorder (ADHD).
But the Island Primary Care Trust (PCT) said the criticism was out of step with national and international advice and the number of children being treated with the drugs was proportionate to elsewhere.
The Citizens Commission on Human Rights (CCHR) accused the PCT of dishing out a 452 per cent increase in drugs to treat ADHD, a condition the organisation claimed did not exist.The CCHR, which was co-founded in 1969 by a emeritus professor of psychiatry and the Church of Scientology to expose what it described as psychiatric violations of human rights, said the figures it obtained highlighted an explosion in the number of children being labelled with the equivalent of a psychiatric ASBO.
FULL STORY ISLE OF WIGHT COUNTY PRESS
Like them or loathe them, the Church of Scientology, certainly seem to be banging from the same drum as many of us 'activists'
Wednesday, July 25, 2007
On June 27, 2007 Bush's Big Pharma friendly CDC issued a press release clearly aimed at increasing the sale of SSRIs to pregnant women. "Use of certain antidepressants, selective serotonin-reuptake inhibitors most commonly known as SSRIs, during pregnancy does not significantly increase the risk for most birth defects," the CDC wrote.
The press release cited a new CDC study released in the New England Journal of Medicine and further stated, "a second study on SSRI and birth defects, also published in the June 28 issue of NEJM, did not find such an association with birth defects overall, but did find significant associations between specific SSRIs and several birth defects."
Continue reading her five page story HERE
The Belfast Telegraph has, in recent times, covered the tragic and distressing subject of suicide and examined the reasons which may lie behind people's decision to end their lives.
It is important also to acknowledge the fact that anti-depressants can lead to suicide.
The Seroxat scandal should be a warning to people and doctors about the very real dangers of these drugs, as well as the increased anxiety, agitation, emotional instability, aggression and other behavioural abnormalities which may result from such prescription drugs.
Research in Northern Ireland must urgently investigate how many people were on anti-depressants at the time of their suicide.
Depression and suicide have social environmental causes which require solutions in the form of greater social support, rather than chemical approaches which are often biased in favour of marketing, profit making and skewed clinical trial results.
Sean Fleming, Belfast
Tuesday, July 24, 2007
Snazzy backgrounds, hip kinda music, games, video comics ...and WOW!! What a great play on words for Asthma sufferers - 'Battle of the Bronchs'
Does anyone else find this sick?
Jesus! We used to go to our docs, get prescribed the pill, take the pill... and think no more. Now, it seems, Pharma need to push the pills with sugar coated advertisements and games that attract the vulnerable.
PS - Your site sucks, the music is like something from Starsky & Hutch.
For those wishing to see this sickening promotion visit http://www.battleforthebronchs.com.au/
The disclaimer claims the site is suitable for people aged 18 and over - The imagery and hip layout would suggest otherwise.
Naughty GlaxoSmithKline - surely this is breaking some sort of ethical code?
I met up with old friends and made new ones too and will see Big Country perform again on the up and coming mini tour of the UK.
For those interested there are a few videos on youtube of the two gigs I attended, this one from Glasgow and this from Aberdeen.
I owe a lot to music - AC/DC, Dixie Chicks and Big Country helped me through my Seroxat withdrawal - so thanks go in particular to these artists.
*Many thanks to the well wishes for my son Gary. He has now had his stitches removed and had them replaced with butterfly stitches. He's doing ok.
In my absence I received many emails regarding Paxil/Seroxat stories - I'm just going through them now but one that is of importance is the Seroxat Petition. Please visit the link and sign (if you haven't already) HERE
Monday, July 16, 2007
He went to the Isle of Wight to celebrate with his friends.
On Saturday night he was stabbed in the stomach in an unprovoked attack along a coastal path.
His friend, James, was slashed across the face and stabeed in the leg resulting in a severed artery.
Both, I'm pleased to say, are doing fine. My son, Gary had stitches to the 4cm deep wound he recieved whilst James was kept in hospital for two nights.
What a crazy fucked up world we live in.
Saturday, July 14, 2007
Another one for GSK's lawyers to settle out of court. I bet the gagging orders are being drafted up as I type.
Charles H. Johnson & Associates Announce Filing of Securities
MINNEAPOLIS, July 13, 2007 LAWFUEL - The Law Newswire -- Charles H. Johnson & Associates announces that a class action has been commenced in the United States District Court for the Southern District of New York, on behalf of purchasers of GlaxoSmithKline PLC ("GSK" or the "Company")(NYSE:GSK) publicly traded securities during the period October 27, 2005 through May 21, 2007 (the "Class Period).
If you are a member of the proposed Class, you may move the court to serve as a lead plaintiff for the Class on or before August 10, 2007.You do not need to be a lead plaintiff in order to share in any recovery that may be obtained.
The Complaint alleges that GSK failed to adequately disclose the fact that it had performed a meta-analysis (a pooled analysis of several clinical trials) related to Avandia which showed an increased risk of heart attacks. Preliminary results of this analysis were presented to the FDA in September 2005 and updated results were disclosed to the FDA in August 2006. However, results of GSK's meta-analysis were never adequately disclosed to the investing public.
As alleged in the Complaint, on May 21, 2007, before the close of trading, the results of a meta-analysis on Avandia conducted by a doctor with the Cleveland Clinic was reported and published in the New England Journal of Medicine (the "Journal"). Similar to GSK's meta-analysis conducted in 2005 and 2006, results of the meta-analysis published in the Journal revealed that Avandia increased the risk of heart attacks and possibly heart related deaths. As a result of the reports regarding the meta-analysis, the price of GSK securities declined $4.53 per share, or 7.8%, to close at $53.18 per share.
If you purchased GlaxoSmithKline PLC securities during the Class Period, or have any questions concerning this notice or your rights with respect to this matter, please contact:
Neal Eisenbraun, Esq.
Charles H. Johnson & Associates
2599 Mississippi Street
Wednesday, July 11, 2007
Concord, NH: "Every time I saw my Ob/Gyn during my pregnancy, I asked if it was safe to be taking Paxil, and every time he said there were absolutely no risks," says Tanya Barnes. But Tanya doesn't blame the doctor -- he was also kept in the dark about Paxil. "Paxil didn't mention anything about possible birth defects." (FULL STORY)
Batavia, IL: "I took Paxil for two months before I knew I was pregnant," says Shae Conlin. "My daughter lived for one hour until she passed away in my husband's arms." (FULL STORY)
Toledo, OH: " In 2004, my wife took Paxil during the first trimester of her pregnancy," says Roy Gueldenzoph. "Two days after our daughter was born, our doctor gave us two options: do nothing and she dies, or get her to a heart specialist immediately. We opted for the latter." (FULL STORY)
Omaha, NE: "My wife took Paxil before and during her pregnancy and everything was fine," says Trever Hargitt. "This was going to be our third so we knew what to expect -- or thought we did..." Keagan Hargitt lived only three short weeks due to heart and lung failure. "Now we will never know what our son could have grown up to be." (FULL STORY)
Watertown, SD: "Several months after my son Nathan passed away, I started to do a lot of research on PPHN and discovered there was a link between Paxil and the birth defects he had," says Jennifer Berg. "I felt sick, I felt it was my fault." (FULL STORY)
Rutherfordton, NC: "To the makers of Paxil I want to ask this: how you can live with yourselves, when you know that Paxil can cause heart and lung defects and PPHN in babies?" says Wendy Tinsley. "For five months we didn't know if our son was going to survive." (FULL STORY)
Whitby, ON: Due to a bad car accident in 1998 that led to depression and anxiety, Lisa Goring was prescribed Paxil. She became pregnant in 2001 and her doctor said it was safe to stay on this SSRI. Most doctors today know otherwise. (FULL STORY)
Austin, TX: Susie Collins and her husband were thrilled when they found out she was pregnant. But their happiness was shortlived: after an ultrasound, Susie regretted having taken Paxil during her pregnancy. (FULL STORY)
Kentucky:" The doctors told us it was a miracle that our son is alive," said Stephen Buchanan. Kaden was born in May 2004 but Stephen only recently found out about the link between his son's heart defects and Paxil. (FULL STORY)
Many more accounts can be found HERE
I think patients have nothing to fear from taking Seroxat.
Dr. Alastair Benbow
GlaxoSmithKline’s European Medical Director6/13/2002
Thank you GlaxoSmithKline. You truly are a caring company
Tuesday, July 10, 2007
While the maker of Paxil and Paxil CR, GlaxoSmithKline (GSK), was required by law to announce the settlement terms of a parent-driven class action lawsuit in October 2006, it was not required to publicize the fact that those terms were greatly improved and simplified in April 2007. Because of legal actions taken by Public Citizen, many more parents whose children took Paxil before the age of 18 could benefit from the settlement if they only knew about it.
Public Citizen posted a YouTube video to tell these parents that there is a $48 million dollar fund created by GSK to pay them back. Even without receipts, parents can recover up to $100. Any money that is not claimed prior to the August 31, 2007 deadline will revert back to the drug company.
GSK and the FDA warned doctors only last year that Paxil increased suicidal thoughts in this age group, and yet this "popular" anti-depressant has been prescribed to children and teenagers since 1992. Parents believed this information was known and withheld by the company, which opted to settle the case rather than go to trial and be forced to answer some very difficult questions.
Watch the video, spread the word and help parents get the refund they deserve. Visit http://www.paxilpayback.org/
GlaxoSmithKline was required to announce the settlement terms last October, but wasn’t to publicize that the terms were improved and simplified in April.
$48 million is sitting in a fund waiting to pay back parents whose children were on Paxil before their 18th birthday.
If they don't claim it then GlaxoSmithKline will keep it.
Help spread the word
Monday, July 09, 2007
July 7, 2007
Glaxo hobble the Tempus Ten
Halfway through 2007, there is still plenty of room for improvement in this year’s Tempus Ten. After a slow start during the first quarter, the portfolio has lost further momentum over the past three months.
...The biggest disappointment during the second quarter came from GlaxoSmithKline (GSK), which, having been up 9.7 per cent in the first three months of the year, is now showing a 2.9 per cent loss. The culprit is Avandia. A study published in May by The New England Journal of Medicine argued that the bestselling diabetes treatment was linked to increased heart attack risk. That claim has sent prescriptions for Avandia, GSK’s second biggest drug, plunging. It has also brought into further question the longer-term success of the £130 billion merger of Glaxo Wellcome and SmithKline Beecham (SB) in 2001: not least, the fact that the three blockbuster treatments brought to the deal by SB – Augmentin, Paxil/Seroxat and Avandia – are those that have caused the combine, now valued at £74 billion, its biggest headaches.
It was the picture of the perfect Toronto family--David Carmichael, a nationally-known fitness guru, his two children and wife, Elizabeth.
"We had a great life," says David. But in 2003, with mounting financial pressures and increasing work demands, David began to change in ways that alarmed his mother, Doreen.
"He lost weight very quickly--and his colour changed. It was not his normal colouring. It was more gray... and it wasn't the way it should have been," she says.
David went to his family doctor, explained his symptoms and was told he was in a major depression. His doctor prescribed a daily dose of 40 mgs of Paxil, one in a group of antidepressants called SSRIs, or Selective Serotonin Reuptake Inhibitors.
After eight months, David was feeling himself again, and weaned himself off the drug.
But a year later, in the summer of 2004, depression returned with a vengeance.
"It was like a freight train. You know, the symptoms just suddenly reappeared and within a matter of days I knew I was in trouble."
Instead of going back to his doctor, David started himself back on 40 mgs of Paxil.
What David didn't know was that new studies were raising concerns about the side-effects of SSRIs, and that by mid-2004, Health Canada was advising Canadians of stronger warnings for SSRIs and other newer anti-depressants. These new warnings indicated that patients taking these drugs may experience behavioural or emotional changes that could increase their risk of harming themselves, or others.
"I started to have suicidal thoughts after I put myself back on Paxil," he explains.
The drug wasn't working for him the way it did the first time, and he'd read in a book that a dosage up to 60 mgs was safe, so he upped his own dose.
"I became delusional, I started thinking that my son was in a living hell," says David.
Ian Carmichael, then 11, did have some minor learning disabilities, but he also had a winning personality and a passion for BMX biking that David encouraged. He had had a few epileptic seizures, but in David's mind, the epilepsy became permanent damage. David fell under the delusion that Ian was going to become violent and hurt other children.
What David didn't know was that he was falling into a deep state of psychosis.
"When you're in that state, you don't realize that your mind is thinking in such a distorted way," he says.
On July 31st, 2004, under psychotic delusions, David took Ian to a hotel in London, Ontario, and strangled him.
David was charged with first-degree murder, but found not criminally responsible due to his mental illness, and transferred to the forensic psychiatric facility at the Brockville Mental Health Centre in Ontario for treatment.
What wasn't brought up in court, was whether the drug he was on at the time had anything to do with David's psychotic state.
"... it has the pattern of 50 or 100 cases I've looked at fairly closely where people have committed mayhem, murder or suicide under psychiatric drugs," says American psychiatrist Dr. Peter Breggin.
"The pattern is that the person stopped the drugs and then started the drug. Carmichael started the drug again, less than three weeks before he kills his child. And what we find is that it's that initial few weeks when the drug has the most impact, when it's either increased in dose, decreased in dose, or stopped."
W-FIVE approached GlaxoSmithKline, the makers of Paxil, for an interview on possible links between their antidepressant and this violent act, but they declined to participate. In a newspaper report this summer, spokesperson Peter Schram said:"David Carmichael's case is certainly a terrible tragedy, however we do not believe Paxil played any part in this situation."
Dr. John Bradford, forensic psychiatrist with the Royal Ottawa Health Care Group, does not subscribe to the theory that Paxil triggered David's psychosis. He was one of the first to assess David's mental health after the tragedy.
"I'm not purely in myself entirely convinced it's the drugs that are at fault," he says. "I think it would be a very wrong message to give. These drugs have ... helped millions of people and I have no reservation in prescribing them. I've been prescribing them for years."
We may never know exactly what caused David's psychotic state, which leads to the question, could it happen again?
Dr. Bradford says it's unlikely. What he's more worried about is whether David can ever really forgive himself for killing Ian.
"...David is doing well at this time, but I'd always worry about suicide risk in the future, because whether he is actually able to ever come to absolute terms with himself about forgiving David for what he did is going to be an open question."
W-FIVE: Over the edge, part one
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W-FIVE: Over the edge, part two
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David Carmichael's website
2004 release: Health Canada advises Canadians of stronger warnings for SSRIs and other newer anti-depressants
Health Canada Endorsed Important Safety Information on PAXIL® (paroxetine)
The memo also shows that FDA reviewer Dr David Ross recommended a highlighted boxed warning for CHF, a life-threatening condition that occurs when fluid builds up in the lungs causing a severe shortness of breath that requires immediate medical attention.
The memo also recommended that macular edema, a condition that causes swelling of the retina and can lead to blindness, be listed as a serious adverse event on the label.
Full story by Evelyn Pringle HERE
Wednesday, July 04, 2007
'Upset and angry' at lack of action
by Richard Brook Chief Executive, Mind
The so-called recent independent enquiries into the safety of SSRI's, a type of antidepressant - which include Seroxat - have been beset by scandal and failure.
These drugs have been reviewed by the UK government regulator five times over the last decade yet the most recent review has highlighted some disturbing facts.
First, in March 2003, the Medicines Control Agency (MCA) expert group had to be reconvened after it was revealed that two members of the group held shares in GlaxoSmithKline, the manufacturer of Seroxat, one of the very drugs they were supposed to be investigating.
Secondly, in June 2003, I was quite horrified when GlaxoSmithKline handed the Medicines and Healthcare Products Regulatory Agency (which replaced the MCA) evidence demonstrating that Seroxat can cause some young people under 18 to become suicidal.
Yet, this evidence came from studies predominantly carried out in the late 1990s and the last one completed by early 2001.
Thirdly, in March this year, I learnt that the agency had possessed information for more than 10 years about significant withdrawal effects if Seroxat was taken in doses of more than 20mg.
This had been included in the original data submitted by GlaxoSmithKline from which the licence for Seroxat had been first awarded a decade previously.
Around 17,000 people were taking a dose of more than 20mg, but the MHRA had failed to take action before this.
I was, at this time, serving on the MHRA's expert group examining the safety of SSRIs, and felt no option but to resign.
The MHRA had tried to pressurise me not to publicly reveal that it was, in my view, effectively ignoring data from 10 years ago. I was not prepared to go along with such secrecy over what is a matter of public safety.
" I said at the time of my resignation that the MHRA was either guilty of extreme negligence or worse dishonesty, and I stand by that now "
The agency then accused me of causing unnecessary alarm by revealing the truth. Either the agency didn't understand the full implications of the medical data or, worse, that the data was fully understood and they failed to act.
Whatever way you look at it, by enclosing itself in secrecy the MHRA was failing its duty to the public. This is unforgivable.
Despite the previous four major regulatory reviews during the ten years and considerable consumer concern in the media, the public has never heard the truth about Seroxat - something that is the responsibility of the MHRA.
I said at the time of my resignation that the MHRA was either guilty of extreme negligence or worse dishonesty, and I stand by that now.
It was only this week a woman told me how her 18-year-old daughter committed suicide shortly after starting to take Seroxat again and days before it was banned for children and young people.
If that ban had been in place earlier it would have meant that she wouldn't have used it during the last two years of her life.
This mother was convinced that if she and her daughter had known about the risks of Seroxat she would not have taken it.
She will always be haunted by wondering whether her daughter would be alive today if she had not taken a drug which, we were all told, had no dangerous side effects.
My job at Mind is to try and act on behalf of mental health service users. The MHRA should, at the end of the day, be doing the same for all patients.
There should be a public enquiry into drug regulation. If the sorry story of Seroxat is not convincing enough, look at past events.
Remember the scandal in the Eighties of the benzodiazepine drugs, such as Valium, when tens of thousands of people told of their horrors of addiction?
People who took benzodiazepines complained - and still do - of blackouts, epileptic seizures, memory loss, brain damage, insomnia and personality change. At first the drug regulators did not accept benzodiazepine addiction, or "dependence".
" It makes me upset and angry that no real action is as yet resulting from this tragedy unfolding before our eyes "
It was only when, once again, Mind teamed up with another TV programme, "That's Life", to survey evidence from thousands of benzodiazepine users that the regulators were forced to face up to the scourge of addiction.
Subsequently, in 1988, the Committee of Safety of Medicines advised for benzodiazepines not to be prescribed for more than four weeks. Too late, I'm afraid, for thousands of people up and down the country.
We must urgently establish an independent drug regulatory agency which is supported with adequate government funding and operates independently from the drug industries' influence.
This is even more vital considering that more than 90 per cent of published research into antidepressants is funded by pharmaceutical firms. Yet, their raw data is often hidden away, unavailable to scrutiny from independent researchers.
At the moment, the MHRA receives its entire funds from drug firm licence fees, and some of the professionals sitting on key MHRA committees own shares in or work in institutions that receive research grants from pharmaceutical firms.
Having shares does not prohibit you from serving with the MHRA. It just means you must not give your opinion on the particular drug whose manufacturer you own shares.
Upset and angry
This arrangement is simply not robust enough to give us confidence that undue influence does not occur.
The MHRA also only takes seriously clinical trials and clinical data and, in reality, ignores the experiences of people actually using the drugs they regulate.
Shocking testimony of those who say their lives have been ruined by horrendous side effects of Seroxat is abundant, and much of it has been recorded on side-effect reporting cards - called "Yellow Cards - submitted to the agency. In light of the lack of influence they have had, these Yellow Cards might as well have been thrown in the bin.
It makes me upset and angry that no real action is as yet resulting from this tragedy unfolding before our eyes. I am not against the prescribing of any medicines including anti-depressants that are beneficial and work for individuals.
But I am against inappropriate and dangerous prescribing brought about by the failure to license medicines adequately.
Related to this story:
Taken on trust (21 Sep 04 Panorama )
Medicines regulator 'under fire' (02 Oct 04 Health )
Q&A: Medicines regulation (03 Oct 04 Panorama )
Panorama's two year journey (03 Oct 04 Panorama )
Information and helplines (01 Oct 04 Panorama )
Self harm and stress groups (01 Oct 04 Panorama )
Useful websites (03 Oct 04 Panorama )
Seroxat and Panorama: Timeline (03 Oct 04 Panorama )
Why we needed to regulate (03 Oct 04 Panorama )
Seven years of struggle (03 Oct 04 Panorama )
Seroxat: The viewers stories (03 Oct 04 Panorama )
Your comments (01 Oct 04 Panorama )
RELATED INTERNET LINKS:
Panorama: The Secrets of SeroxatPanorama: E-mails from the edge
Then write to the Chief Executive of the MHRA, Kent Woods, here:
Professor Kent Woods
Medicines and Healthcare Products Regulatory Agency
1 Nine Elms Lane
Or you could email him here: firstname.lastname@example.org
If he chooses not to answer then you can email the MHRA and ask them to forward your concerns on to Kent Woods. Email them here: email@example.com
It seems GSK didn't put up much of a fight - that in itself should have had alarm bells ringing within Caraco
Personally, I think it is a huge risk by Caraco Pharmaceutical Laboratories Ltd but hey ho, it's their loss at the end of the day and I won't be losing any sleep over it.
Generic drug developer Caraco Pharmaceutical Laboratories Ltd. said Tuesday the Food and Drug Administration granted final approval for a version of GlaxoSmithKline PLC's antidepressant Paxil.
The FDA approved the Detroit-based company's version, called paroxetine hydrochloride, which is indicated for the treatment of major depressive disorder, panic disorder, obsessive compulsive disorder, social anxiety disorder, generalized anxiety disorder and posttraumatic stress disorder.
Caraco offers 10-, 20-, 30- and 40-milligram strengths.
British drug maker GlaxoSmithKline (nyse: GSK - news - people ) booked 620 million pounds ($1.25 billion) in Paxil worldwide sales in 2006.
GlaxoSmithKline's patent on Paxil expired on June 29.
Shares of Caraco rose 33 cents, or 2.2 percent, to close at $15.62. Trading ended at 1 p.m. in an abbreviated session ahead of the July 4th holiday.
Prescription weight-loss drug Xenical hit drugstore shelves on Friday with a new name -- Alli (pronounced: "Al-eye") and with a new non-prescription strength. The newly-named drug is to be more effective with less unpleasureable side effects. Still, there's a problem surrounding this drug, regardless of its name. It's thought to cause colon cancer
The nonprofit group Public Citizen says Alli, made by GlaxoSmithKline, has been shown in mice studies to cause pre-cancerous lesions in the colon. Since there are no long-term studies on humans, this group believes the FDA should not have approved the drug for non-prescription use. It's not clear whether or not the pre-cancerous spots will lead to colon cancer but the mere suggestion that it might is enough, says a Public Citizen spokesperson.
"What we do know is that these lesions occur much more frequently in people who do get colon cancer," he said. "Why do we recommend that everyone get a colonscopy at the age of 50? Because you pick up on these polyps when you do one. And, even though not all of the polyps are pre-cancerous, no (doctor) does a colonscopy without removing every single polyp that is found. And you do this because you know if you don't, it greatly increases the chances of getting cancer."
The FDA says there is not enough evidence to link Alli and colon cancer -- or breast cancer, another Public Citizen concern.
Monday, July 02, 2007
NEW ORLEANS -- Dr. Maria Carmen Palazzo was indicted by a federal grand jury on 55 counts of health care fraud and false documentation in connection with a clinical trial of Paxil in children and adolescents, U.S. Attorney Jim Letten said on Thursday.
The indictment alleges that during approximately a five-year period, Palazzo, 55, of New Orleans, defrauded Medicare in connection with services she claimed to have rendered to patients in a Psychiatric Partial Hospitalization Program at Touro Infirmary.
The indictment also charges that Palazzo defrauded Medicare by submitting fraudulent invoices to Touro for consulting and medical director services. The indictment says because of that Medicare paid Palazzo over $653,000 she was not entitled to receive.
Palazzo, who specializes in psychiatry, is also charged with offenses relating to clinical trials involving Paxil.
According to the indictment, Palazzo, as a clinical investigator for SmithKline Beecham doing business as GlaxoSmithKline, fraudulently failed to maintain and prepare records required by the FDA for evaluation the drug's safety and effectiveness in children and adolescents.
If convicted, Palazzo faces a maximum term of 445 years, and a fine of $10.15 million, Letten's office said.
Copyright 2007 The Associated Press. All rights reserved
Sunday, July 01, 2007
I, myself, and a whole host of others have wrote to the GMC regarding the actions of Dr Alistair Benbow, Head of European Clinical Psychiatry GlaxoSmithKline. We have ALL been stonewalled by the GMC. It seems evidence provided is not good enough to warrant an investigation.
Yet another industry/agency out to protect themselves rather than the British public.
Alistair Benbow has continuously denied any links between Seroxat and addiction, suicide, violence - yet the company he works for, GlaxoSmithKline, contradict these statements.
Charles Medawar of Social Audit has also been having a great deal of trouble getting his complaint recognised by the GMC. The following link provides correspondence between Mr Medawar and various 'employees' of the GMC.
Judge for yourselves HERE
Harold Shipman was one of the most prolific known serial killers in modern history. He was convicted on 15 sample charges in 2000 and sentenced to 15 consecutive life sentences.
Alistair Benbow has sat back and allowed people to die - he has robustly denied any link between Seroxat and Suicide. Was he around during the Paxil 329 study?
My message to the GMC is plain and simple:
GET YOUR FINGER OUTTA YOUR ASS AND STOP PROTECTING THIS MAN WHO HAS COMMITTED ONE OF THE MOST HEINOUS CRIMES IN MEDICAL HISTORY.