Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Showing posts with label Sertraline. Show all posts
Showing posts with label Sertraline. Show all posts

Friday, July 28, 2017

Panorama: Prescription For Stigma?



By Bob Fiddaman & Kristina Gehrki

This week I watched BBC's eagerly anticipated Panorama documentary, "A Prescription For Murder?" I say 'eagerly anticipated' because on the day it was scheduled to air, organizations that routinely run from public dialogue were tweeting away in the wee morning hours. This includes the Royal College of Psychiatrists (RCP) and the Medicines Healthcare Products Regulatory Agency (MHRA). They took to Twitter long before viewers had an opportunity to view and judge Panorama's programme on its own merits.

MHRA, RCP and other so-called "mental health" organizations, claim the show stigmatized those who use antidepressants. RCP tweets included:
#BBCPanorama claims irresponsible and unfounded. Scaremongering title alone shows real stigma people taking #antidepressants face.
More #antidepressant prescriptions=more people getting help. Not more potential murderers. Don't stigmatize people needing help #BBCPanorama 
Professor Louis Appleby later chirped:
A media throwback: sensationalist, exploitative, not even new, with stigma & risk to patients collateral damage.http://www.bbc.co.uk/programmes/b08zjyp1 …
The MHRA's limp-wristed, London-based suits tweeted:
SSRIs have been used to effectively treat millions of people worldwide & like all medicines, the safety is continually monitored. (Notice that MHRA did not state "SSRI drugs do not cause an increase in suicide or homicide.")
I immediately tweeted back:
You forgot to add that your CEO is the former World Safety Officer for @GSK
Many other mental health charities and patients tweeted their disapproval. A majority of complainers seemed annoyed by the documentary's title. I pointed out the title had a question mark after it, ergo it was posing a question, not making a statement. But this obvious fact seemed to be lost on those who bombarded Panorama's Twitter page.

Out With the Old, In With the New

For decades, Big Pharma has made wildly inaccurate claims about everything from the chemical imbalance theory to the legitimacy of their own "science." Today the old chemical imbalance campaign seems to be replaced by the new stigma campaign. It is an emotional appeal to try and convince the public that people who speak on behalf of drug safety are shaming those who consume prescription drugs. The reality is that drug safety advocates only want consumers to know the real risks so they can make an informed personal choice.

Drug companies, regulators and "mental health" organizations aggressively brand drug safety advocates as "stigmatizers." They want the word "stigma" to carry similar emotionally-charged perceptions as the word "racism." This diversion is sickly twisted, but a clever communications tactic nonetheless.

The problem is stigma isn't relevant to drug safety discussions. As Thomas Insel, former director of the National Institutes of Mental Health (NIMH), discusses in the documentary "Letters from GenerationRX," stigma isn't even much of an issue in seeking mental health "treatment." Insel states "The fact is that actually more people are getting more treatment than ever before" and yet the suicide rate "has not come down." The reason, surmises Insel, is "We (the mental health profession) don't know enough."

To see Insel's interview and the tragic SSRI experiences of many families, "Letters from GenerationRX" is available here.

The stigma campaign is designed to create a false public rift to hinder open dialogue about medical freedom of choice and drug safety. Drug companies don't want people to recognize it is a fundamental human right to know the real risks vs. benefits of their product before consumption. Few consumers would consciously choose to forego this right and Pharma, the MHRA, and RCP know it.

Their propaganda is a recipe for disaster. To ignore serious side effects causes thousands of deaths. These organizations create an imaginary enemy and imaginary "war" of sorts. Pit two sides against each other and stir the pot. They then sit back, enjoy the heated conflict, and stealthily pad their pockets.

Brief Summary of "A Prescription For Murder?"

Panorama's hour-long documentary mainly focused on mass murderer James Holmes. It posed the question of whether the SSRI Holmes was prescribed before the Colorado shootings played a role in his actions. The drug Holmes was prescribed in increasing doses is called sertraline, better known by its brand names of Lustral and Zoloft. It is made and marketed by Pfizer Pharmaceuticals. As Pfizer's own scientist, Dr. Roger Lane, has confirmed, Zoloft and other SSRIs can cause akathisia. Lane describes akathisia as "subjective distress" and "unbearable discomfort." He states akathisia sufferers "can feel death is a welcome result" to end their symptoms. (Source) - The source is hosted on Woody Matters, a website created by the wife of Woody Witczak, Kim. Woody died a violent death after taking sertraline for a total of 5 weeks with the dosage being doubled shortly before his death.

Panorama's investigative reporter, Shelley Jofre, interviewed many sources to include Holmes' parents, the prosecuting attorney, and several healthcare professionals. The show also briefly featured two other tragedies, that of Shane Clancy, who experienced adverse drug reactions (ADRs) from citalopram (1)  The programme's aim, as I see it, was to explore whether the connection between SSRIs and violence is legitimate.

The documentary, which hasn't yet aired outside the UK, was a year in the making and appeared well-researched. I won't give away too much program info because many people outside the UK haven't yet seen it. Suffice it to say; it was riveting.

(Note: In 2002 Jofre aired "The Secrets of Seroxat." It focused mainly on SSRI withdrawal problems but also shared the tragedy of 60-year-old Don Schell. After taking just two Seroxat tablets he killed his wife, daughter, and infant granddaughter before killing himself. ) Jurors ruled in favor of the man’s relatives and also ruled that taking Seroxat was the proximate cause of all these deaths.

Real Data Linking SSRIs to Violence

The MHRA is, according to the programme, aware of at least 28 homicides associated with SSRIs. Further, 32 additional reports have been sent to them showing an association between homicidal thinking and the use of SSRIs (Fig 1).


Fig 1

Predictably, the MHRA has never followed up these reports as it is not in their financial interests to do so. Therefore, they can then continue to claim that, "although these drugs have been associated with homicide and homicidal acts, it doesn't mean that the drugs caused the acts." It's akin to an airline ignoring reports of loose rivets and refusing to conduct any investigations in response to the reports received. After the plane crashes and innocent people die, the airline officially declares "We can't be certain loose rivets caused the crash."

This week's Panorama documentary further confirmed for me that those who cavalierly promote and push these drugs at alarming rates, while loudly crying "stigma," are actually trying to stigmatize those who have been harmed by the real effects of these drugs. Further, they don't value all human lives equally: those who suffer fatal side effects seem inconsequential.

A publicly-funded PR campaign doesn't exist for those who have suffered and/or died from these drugs. We don't have well-oiled PR machines to spin false data nor journalists ready to write misleading stories in the mainstream press. We don't take drug money in exchange for dishonest research. When we speak truth to medical power, it is we who are negatively labeled by an uncaring profession and corrupt regulators who have personally profited from drug industry ties.

But there is one thing we do have--something priceless that no marketing budget can buy: our honest and real lived experiences. If you're still uncertain about the adverse drug reactions Zoloft and other SSRIs cause, read the diary entries of a barely nineteen-year old girl who unwittingly documented her adverse drug reactions and psychiatric abuse. Natalie Gehrki, barely 5 feet tall and 110 pounds, was prescribed Zoloft in increasing doses. Her final dose was prescribed over the phone without ever being seen by her doctor. The doctor did not inform Natalie's mom that an increase had been directed and since Natalie already had the Zoloft prescription in hand, she simply took the maximum dose as her trusted doctor instructed.

Like Holmes' doctor, Natalie's doctor failed to recognize signs of SSRI-induced akathisia, and she increased the offending drug (Zoloft). Holmes was prescribed 150 milligrams of Zoloft at the time of his psychotic murders spree; Natalie was prescribed 200 milligrams and violence ensued a few days after consumption. Blood tests later showed Natalie was not an efficient metabolizer of SSRI drugs. Oh, well; perhaps the FDA might look into metabolization issues one day so other children might live?

"Netherworld," Natalie's story produced by Miller, is available for free here.

Further SSRI/Homicide related cases

Investigative reporter, Andrew Thibault, has uncovered much more through a series of Freedom of Information requests from the Food and Drug Administration (FDA). Many of the documents were heavily redacted, but all have one thing in common: All patients carried out an act of homicide whilst under the influence of a SSRI. The documents have been made public, and I wrote a series of blog posts about this back in 2016.

Seroxat/Paxil (paroxetine) - GlaxoSmithKline
Cipramil/Celexa (citalopram) &  Lexapro/Cipralex (escitalopram) - Lundbeck/Forest
Prozac (fluoxetine) - Lilly
Lustral/Zoloft (sertraline) - Pfizer

To view A Prescription For Murder, go to the BBC IPlayer here. (UK ONLY)

Shout out to Katinka Blackford Newman, author of The Pill That Steals Lives, who was the development researcher for this programme.

Bob Fiddaman & Kristina Gehrki


1. When Leonie and Tony Met Lundbeck (citalopram manufacturers)








Monday, July 17, 2017

Paxil/Zoloft Homicide - "Unlabelled Potential Side Effects"





Last year I wrote about Andrew Thibault who, just like me, has been at loggerheads with the those who oversee the safety and efficacy of drugs on the market. Thibault has successfully obtained many documents off the FDA, which he has made public at murdermeds.com.

Earlier today a series of tweets peaked my interest. Pharmabuse is a Twitter account that has the tagline, 'Parents Against Pharmaceutical Abuse (PAPA)', and their website, pharmabuse.com is a minefield of information.

Rather brilliantly, Thibault has filed a lawsuit against the FDA because, well, because they don't seem to be playing ball with requests he made to them under the Freedom of Information Act. (Sound familiar?)

Thibault's series of FOIA's involved questions relating to documents that the FDA had in their possession regarding psychiatric medication and homicide, moreover whether or not there was a link to the two.

A 25 page document highlights the FDA's obvious stonewalling of Thibault, a game that drug regulators like to play with anyone who asks for records that may show them in a bad light. The document is a fascinating read and I urge you all to read and share it, if only to see the outcome :-)

So, what has the title of my blog post got to do with the MHRA?

Well, earlier today Thibault made another document publicly available, a document which he obtained under the FOIA from the FDA. It involves two antidepressants, namely setraline (Zoloft) and paroxetine (Paxil/Seroxat). The document is AERS Case Number 6330848 and is just 4 pages in length. It's an adverse event report from an unknown person (it's been redacted) who experienced the following side effects whilst taking both paroxetine and sertraline...

Agitation
Depression
Homicide
Restlessness
Suicidal ideation
Suicide attempt
Tension

As you will note, there is one adverse event in the list that sticks out like a sore thumb: Homicide.

The causality assessment regarding homicide reads "possible."

When carrying out an assessment of the adverse reaction report the MHRA , according to the tweet I recieved earlier, had this to say about both drugs. Pay particular attention to the last paragraph.



CLICK IMAGE TO ENLARGE



I'm not quite sure what "unlabelled potential side effects" means? According to Pfizer  an unlabelled side effect is an unexpected adverse event. Begs the question, how many more have they had?

It's interesting, to me at least, that the MHRA have thrown in the word 'potential' which, in essence, means possible, likely, or probable.

It's quite bizarre that, in its assessment, the MHRA can state quite clearly that agitation
depression, restlessness, suicidal ideation and a suicide attempt were assessed and rated as possibly related to paroxetine use yet, despite this, they claim there is insufficient evidence to assess the causality regarding the homicide, opting instead to label it as an "unlabelled potential side effect." They do pretty much the same in their assessment of sertraline.

When you read this four page adverse event in conjunction with the 25-page court document filed by Thibault all, it seems, becomes crystal clear. In filing his lawsuit Thibault claims that the FDA told him in a telephone conversation the subject matter he had requested "did not make for fun reading", adding that he (Thibault) "should take into account "psychiatric diagnoses of the patients."

It's almost as if they have resigned themselves to the fact that the information is explosive yet, on the same hand, they are guiding Thibault away from the medication causing the adverse events and leading him toward their blame the patient mantra which they have spewed for many years.

Both the FDA and the MHRA maintain that SSRIs do not cause a person to carry out a homicidal act. This despite a large number of high profile cases that implicate many SSRIs. I covered many of Thibault's FOIA documents last year that, to me at least, show a very worrying link. Back stories at the foot of this post.

For years they have covered up the withdrawal problems patients face when taking these drugs, they have covered up the suicide links regarding these drugs. Safe to assume then they are sitting on more information regarding the homicide link with these drugs. But hey ho, I'm just a smeary conspiracy theorist.

The full 4-page document is now available here.

Thibault's lawsuit against the FDA can be accessed here.

Well done Mr. Thibault. I salute you, sir.

On Wednesday July 26, 2017 Panorama will air in the UK in an hour long special and will reveal the devastating side effects that can lead to psychosis, violence, possibly even murder.

The BBC website reads...

With exclusive access to psychiatric reports, court footage and drug company data, reporter Shelley Jofre investigates the mass killings at the 2012 midnight premiere of a Batman movie in Aurora, Colorado. 24-year-old PhD student James Holmes, who had no record of violence or gun ownership, murdered 12 and injured 70. Did the SSRI anti-depressant he had been prescribed play a part in the killings?
Panorama has uncovered other cases of murder and extreme violence which could be linked to psychosis developed after the taking of SSRIs- including a father who strangled his 11-year-old son.
Panorama asks if enough is known about this rare side effect, and if doctors are unwittingly prescribing what could be a prescription for murder.

I, for one, will be watching it.

Bob Fiddaman



Previously in the Homicide Files series.







Thursday, May 19, 2016

The Homicide Files: Zoloft






The is the sixth in the Homicide Files series (previous 5 are at the foot of this post)

Today I focus on Zoloft (sertraline), an antidepressant of the selective serotonin reuptake inhibitor family.

Zoloft is manufactured and marketed by Pfizer and is the subject of many lawsuits in the United States, alleging, amongst other things, that Zoloft is ineffective (doesn't work), that it causes birth defects and that it causes violence and suicide.  It is known as Lustral in the UK.

The first file today is 99 pages in length and concerns a 27 year-old male. I'm not going to publish all the 99 pages, if you want to view the whole document then you can do so here.


AERS Case Number 4073159

27 year-old male, prescribed 100mg Zoloft per day between 1996-1998. Patient, according to the first page of the document, murdered an acquaintance of his. Moreover, the report says, "Either chronic use or sudden involuntary withdrawal caused a major psychotic event where "patient" murdered an acquaintance of his.




--

AERS Case Number 4088468

20 year-old male prescribed 50mg of Zoloft per day between Oct 24, 2003 - January 23, 2004.

The report was sent to Medwatch by the parents of the 20 year-old who state that their son experienced an adverse reaction to Zoloft and killed a "friend of a young woman" in their home.




--


AERS Case Number 5838493

19 year-old male. Prescribed Zoloft between 2003-2004. The report was sent in by a psychologist who said, "The patient started taking Zoloft (50mg) for one week then 25mg daily for two weeks." The psychologist also states, "On day 13 of his Zoloft therapy he decided it was not working and stopped taking in for 3 days, then he restarted Zoloft at 25mg daily."

Days later he killed someone.

His parents said, he committed the murder because of persistent severe agitation and aggression from Zoloft.




--

AERS Case Number 6100809

Homicide by a 32 year-old female who was taking Zoloft (dosage unknown) because she was having 'mental problems' for 3 to 4 months.




--

AERS Case Number 5837912

37 year-old female. Prescribed 200mg of Zoloft per day. She killed her son then attempted to kill her daughter. You'll note in this document how the reporter makes claims that the female patient may have been taking another prescription drug at the time of the murder. This, according to the document, was never proven. 




--

AERS Case Number 5668352

70 year old male. Was taking Zoloft (date unknown)  - He killed his wife and them himself. The report was sent in by one of the children. It states, "He did not have a history of depression... we all knew it was the drug when this happened"




--



So, six more cases of prescripticide. Feel free to read the links below to cases of other antidepressant medication.



Bob Fiddaman.



Previously in the Homicide Files series.








**Prescripticide is defined as a death that is caused by an adverse reaction to a prescription drug.










Tuesday, May 19, 2015

Danilo Terrida - Zoloft Suicide







Danilo Terrida (20)




It's been said that writing with emotion can either a, turn you into a great writer or b, land you in hot water.

This is the story of  Danilo Marcello Terrida, a 20 year-old student from Denmark.

What you are about to read defies all belief, it's malpractice of the highest order. Its secrets and lies designed to make one pharmaceutical company rich at the expense of taking a kid in his prime, a young man that had his whole life in front of him and everything to live for.

Danilo was 5 hours away from home - he'd enrolled at the Maritime college in Frederikshavn, Denmark and on one evening in mid-October 2011 he was missing his family and friends back home in Sjælland.

Feeling low and lonely Danilo decided to visit the Emergency Medical Service in Frederikshavn for help. Once there he was given an antipsychotic and told by staff that he should go back to Maritime College and contact a General Practitioner (GP)

Danilo contacted a GP in Frederikshavn but was told that it would be best to contact his own GP in  Hellerup, some 400 km away.

What happened next really does not surprise me. It still shocks and saddens me that doctors can be so ignorant when it comes to diagnosing someone who was just feeling lonely and distant from his family.

Danilo made the call to his GP, Dr. Ole Knudsen. and, after just 8 minutes, was prescribed sertraline (Zoloft) - Remember, this was not a face-to-face consultation, this diagnosis and subsequent prescription was all done over the phone. Zoloft is manufactured and marketed by pharmaceutical giants, Pfizer.

The prescription, I presume, was faxed to Danilo who then dispensed it.

This from his parents...

"In the following 11 days, Danilo followed the doctor’s recommendations about how many pills he should take, and after seven days, he doubled his dose, as he had been told, despite the fact that research has shown how dangerous high doses of Sertraline can be to young people. Meanwhile he got worse and worse. He complained of extreme headache, could not concentrate or sleep and had nausea.

"On October 25, 11 days after Danilo had begun his recommended treatment with “happy pills”, he hanged himself from a crane on the Maritime College. Family and friends were shocked. Danilo had no history of mental illness, he had never before been on antidepressants and that he could kill himself, came as a shock to all who knew Danilo."

 So, another kid killing himself. He was depressed and that's what depressed people do, right?

His prescribing doctor, Ole Knudsen, somehow waved a magic wand, looked into his crystal ball and, after just 8 minutes, deemed that 20 year-old Danilo was in need of a box of pills to make his loneliness disappear. What kind of knucklehead thinks he has the right to prescribe a lonely 20 year-old powerful mind-altering drugs over the phone?

Hey, Knudsen, I'm talking to you!

As if losing their son wasn't bad enough, Danilo's parents then learned, six months after Danilo’s death, that Dr Ole Knudsen had been modifying and adding to Danilo’s health records.

They also learned that the Danish National Board of Health, the limp-wristed equivalent to the FDA and MHRA, had known since 2003 that sertraline increased the risk of suicidal thoughts and behavior among children and adolescents up to 25 years of age.

After being stonewalled, down almost every avenue they have walked, Marianne and Denis Terrida, Danilo's parents, have now decided to go public and a new website has been launched that highlights the story of their son and their son's drug pusher, Ole Knudsen. (Because that's what you are, Knudsen!)

The website is in both Danish and English and shows how a doctor at the emergency medical service chose to hand over 25 grams Buronil – an antipsychotic agent also known Melperone. It is indicated for use in Treatment refractory schizophrenia and, in the UK at least, has not been granted a licence.

So, just to clear things up. Danilo was feeling lonely, he missed his family so some lunatic in a white coat decided that he needed a drug that was suitable for those with Treatment refractory schizophrenia.

It's normally prescribed to patients who cannot tolerate clozapine. So, why did Moron number one prescribe it to Danilo?

Moving on to Moron number two, Dr Ole Knudsen.

This from the Danilo website...

"In eight minutes you can boil an egg. Or run the subway from Nørreport to Flintholm. If you are a busy practitioner, you can also manage to diagnose a patient telephonically and prescribe a dangerous medicine in that time. It did not take longer for Danilo’s own general practitioner, Ole Knudsen to make the decision to prescribe antidepressants to Danilo. A medication that 11 days later would cost him his life. Eight minutes on the telephone was all Ole Knudsen needed to diagnose Danilo with depression and prescribe the antidepressant “Sertraline." Usually, it is normal professional standards for doctors to see the patient for a personal consultation at least twice before a depression diagnosis is made and treatment begins. The fact that Ole Knudsen had only spoken on the phone with Danilo one single time, is very much against the proper treatment when prescribing antidepressants."

You can see the discrepancies Danilo's parents found in Dr Ole Knudsen's notes on this page here.

Toward the end of 2013, some two years after Danilo's suicide was induced by Zoloft, Dr Ole Knudsen was criticized by the Health Authorities Disciplinary Board. They found that Knudsen's record-keeping was inept, that he hadn't given informed consent to Danilo, and never followed up (made contact with Danilo to see how he was coping on the drug)

Knudsen was further criticized by several other authorities for his role in the case, but despite this, according to his parents, he can now continue as a practitioner – without being subject to any legal or economic punishment.

The findings were never made public, they were just sent to Danilo's parents.

The story continues on the website here.

Now, please run the hot water and let me immerse myself.

Dr Ole Knudsen, you are one incompetent asshole. You hide behind the nonsense notion that a 20 year-old who is lonely must be mentally ill because you gave him a whole 8 minutes, during which time you miraculously diagnosed him and treated him with a pill to help with the diagnosis. Well, Knudsen, your diagnosis was wrong as was your treatment and no altering of medical notes can change those two simple facts.

He was just 20, Knudsen. 20 years-old and you gave him a box of pills that are known to induce suicide. Moreover, you didn't even bother to see how he was doing. Your ignorance and lack of care is staggering. Hey, don't worry about it though. Danilo was 'just one of them things that happen', right?

It couldn't have been the drug, the kid had mental health problems, right? He had a shift in the chemicals in his brain and you was only trying to correct that shift, right Knudsen?

If there were a shit list, Knudsen, you'd be sitting at number one.

My thoughts are with the Terrida family.


Bob Fiddaman.


More Info - http://daniloforlivet.dk/english/








Saturday, April 11, 2015

Pfizer in Denial About Zoloft Birth Defects





So, multi-billion dollar making pharmaceutical company, Pfizer, are in court. They are (as expected) denying the link between their antidepressant drug, their multi-billion selling blockbuster Zoloft (Sertraline) and birth defects.

Are we surprised at their denial or surprised that Zoloft can cause birth defects?

Well, neither really.

So here's the case.

Logyn Pesante, (11) from California, was born with multiple heart defects, the most serious being transposition of the great arteries. In a nutshell, transposition of the great arteries occurs when the two main arteries going out of the heart (the pulmonary artery and the aorta) are switched in position, or “transposed”.Since his birth Logyn has undergone 25 procedures and six operations and has a pacemaker. The brave 11 year-old has also had to undergo three open-heart surgeries to address his multiple defects.

His mother, Kristyn Pesante, took Zoloft during the first trimester of her pregnancy and her attorney, Joseph Zonies of the Colorado law firm Reilly Pozner LLP, is claiming that birth defects and fetal deaths, reported by patients to Pfizer as early as 1991 should have seen Pfizer change its label on Zoloft or, at the very least, communicate these adverse events to physicians.

Pfizer's attorneys, Paul Weiss Rifkind Wharton & Garrison LLP. are arguing that that there is no evidence to prove Zoloft causes birth defects. This, despite the adverse events reported to them by patients and also a study published in the New England Journal of Medicine in 2007 which found that pregnant women taking Zoloft faced double the risk of having a child with a birth defect.

More damning, for Pfizer at least, is a document submitted as evidence by Pesante's attorneys that shows a May 2014 internal report at Pfizer sees them admit that women taking Zoloft (sertraline) had an increased risk of having babies with heart defects. The document, Pfizer claim, has been taken out of context. Pfizer claim that, “Plaintiffs have taken a single statement in one document, summarizing the results of a few studies, out of context.”

Robert Cabera, a doctor at a University of Texas institute, has been called as an expert witness for Pesante and told jurors that his review of research on babies born with medical issues convinced him that Zoloft was clearly “a risk factor for birth defects, especially heart defects.”

I'll leave the last words with Beth Wilkinson, (Pictured) one of the lawyers representing Pfizer.



"None of the mother’s doctors had identified Zoloft as the cause of her son’s birth defects and experts say its impossible to know exactly what causes such problems.

“Sometimes, bad things happen to good people,”

Hmmm.

The case is Pesante v. Pfizer Inc., 1222-CCO-2441, Missouri Circuit Court, 22nd Judicial District (St. Louis).

Sources:

Pfizer Accused of Knowing Zoloft Posed Birth-Defect Risk

St. Louis jury hears nation's first suit claiming Zoloft caused birth defects


Bob Fiddaman.






Saturday, January 10, 2015

Key Expert To Give Evidence Against Zoloft (Birth Defects)




A group action seems to be in full flight against in the United States whereby hundreds of mothers are claiming that Zoloft (sold and marketed by Pfizer) caused birth defects in their children.

Initially U.S. District Judge Cynthia Rufe of the Eastern District of Pennsylvania barred the testimony of the group's previous expert,Dr. Anick Bérard, citing several problems with her research.

Plaintiffs sought a new expert and Pfizer objected, claiming that plaintiffs had plenty of time to put in place a reliable expert and bringing a new one forward was merely down to Bérard's testimony being dismissed.

Judge Cynthia Rufe ruled in favour of the plaintiffs and they can now move ahead in their case against Pfizer where they allege that Zoloft (Sertraline) caused a number of heart defects in their children.

Pfizer remains confident that there is no reliable scientific evidence demonstrating that Zoloft causes the injuries alleged by the plaintiffs.

Full story here (subscription only)

Bob Fiddaman

Friday, February 01, 2013

Baum Hedlund Home In on Pfizer's Zoloft



Glaxo's nemesis, Baum Hedlund, Aristei & Goldman, have teamed up with Pendley Baudin & Coffin and filed a lawsuit against pharmaceutical giants Pfizer Inc. regarding the promotion of their antidepressant, Zoloft.

The suit, filed in the United States District Court for the Northern District of California, San Jose Division, alleges that Pfizer, Inc deliberately and falsely misled consumers regarding the effectiveness of the company’s $30 billion blockbuster antidepressant, Zoloft [sertraline].

The lawsuit also alleges that Pfizer, despite knowing the ineffectiveness of Zoloft, went on a huge marketing campaign that, amongst other things, showed how effective Zoloft was.

Documents, obtained through disclosure, hope to prove that Pfizer...



Tuesday, June 05, 2012

Guest Post: Sertraline Sufferers Stand Up and Be Counted!




Today's guest post comes from Sheila Herd who authors the Prozac Withdrawal blog. Sheila, like many others, feels the need to share her experiences because doctor's, drug companies and medicine regulators seem far too busy burying their heads in the sand.

Here's Sheila's story:

Sertraline Sufferers Stand Up and Be Counted!


It can often seem like it’s all about seroxat (paxil) to us folk struggling with the other SSRI’s; Seroxat Mad, Seroxat Sufferers, Paxil Progress, Seroxat User Group, Seroxat Secrets and so on, which is how this post came about, someone piped up  “hey what about us Sertraline sufferers?”, and then I commented about also being a Sertraline sufferer, we were both invited to do a guest post about Sertraline [Zoloft]

I was prescribed Sertraline in 1998 when I had postnatal depression. I went from deep depression/anxiety to euphoria in the space of about two weeks, I felt pretty damned fantastic and became super mum, there was nothing I couldn’t handle. As time went on I continued to feel well but my emotions were dampened down, so I was functioning well, no depression, but no “joy” either, my libido was totally gone but hell who has time for that anyway with a new baby?


After about five months I decided I was feeling so well I didn’t want to be on Sertraline anymore, didn’t read the patient information leaflet or talk to a doctor, not that that would have helped anyway (hollow laugh). I just stopped taking them. My head felt terrible, it began to feel water logged, if I turned my head there was a time lag between my eye balls catching up with the fact that my head had turned, so dizzy, gradually intense sadness would kick in, really really intense sadness and anxiety, oh the anxiety, pumping adrenaline and nerves shot to bits. I went back on the Sertraline.

The doctor told me to do the alternate day thing, alternate days for a fortnight, then every third day for a fortnight, then one tablet a week, I did this various times over the next few years to no avail. I tried a pill cutter and halving the tablet, it wouldn’t break down easily without crumbling so that was unsuccessful. Every time I tried something, I ended up in worse shape than the time before, it was all getting steadily worse. I tried meditation, healing, exercise, cognitive behavioural therapy, counselling, fish oil capsules, NOTHING touched it. I pressured my doctor to refer me to a psychiatrist for advice, but she had no clue and could only recommend switching to another drug. I did switch to Citalopram for a while, and Mirtzapine, I felt constant fatigue on Mirtzapine, and then back to Sertraline.

This is my description of how withdrawal felt from my blog, I only recently found out that what was happening had a name, akathisia:

“5am and for about the 3rd night in a row I’ve barely slept, I can’t stop the adrenaline pumping round my body, my stomach is tightly knotted, I’ve barely been able to eat properly it makes me feel sick. I’m clammy, sweating and crying and P is trying to reassure me, but he has to go to work. I get up and drag myself through all the motions of the day and making sure boys get to school, I feel like the living dead, I make sure they get fed and make sure they and no one else is aware of what’s going on, I don’t hang around at the school gates. Oh I do kind of tell a few people I’m not really feeling right but I play it down. The constant adrenaline is tormenting me on the inside and I can’t stop it. It’s been building up over a period of months and I’ve been fighting and fighting the feelings but it seems to have reached a peak of exquisite torture. It’s like being at the top of a roller coaster that never stops. Someone else mentioned birdsong, and it was a funny thing, the torture was worse in the mornings and over the summer months while it was slowly building, birdsong in the morning outside the window had become a kind of torture as well. I had to go to work only 2 days a week and God only knows how I managed it. I had taken my last Sertraline tablet months ago, and come off it as per the doctors instructions, and now my depression/anxiety was back tenfold to punish me for daring to presume I could stop taking it. I must be wired up wrong, no one else feels like this do they? What is wrong with me? Maybe I really am insane, maybe I just can’t cope with life without my tablets, how come everyone else can cope with life, and I can’t? There must be something fundamentally wrong with me. By now the Orwell Bridge was beginning to look a bit attractive and I just wanted to escape the adrenaline surges torturing me, my nerves were in shreds”.

This was 2003, at the end of 2003 I gave in and went back on the sertraline.

I can honestly understand how suicide happens on these drugs.

In 2006 I attempted another withdrawal, at the same time my father in law became terminally ill, I helped a lot with the hospital appointments and helping my mother and father in law to cope while Peter was working in London, I tried toughing out the withdrawals again, and gave in again. I spent my father in laws final days and his funeral in an unnatural state of euphoria from going back on the sertraline.

So here I was, several years later and no further forward, and not for wont of trying! Everytime I went in a book shop or library I would try and find anything I could about antidepressants and depression, but nothing really enlightened me. I rummaged around on the internet but couldn’t find the answers. Until one day, I was browsing around Waterstones, and “Coming off Antidepressants” by Joseph Glenmullen jumped out at me, I read it avidly, and discovered TAPERING!!!  But, all the examples in the book referred to liquid Seroxat or Prozac, I was really upset to find Sertraline was not available in liquid form. Armed with my new information about the simple concept of tapering, further digging led me to Dr Healy’s protocol of switching to the equivalent dose of liquid Prozac. These two pieces of information became my secret hope, I latched onto them. I decided to take a leap of faith and switch to liquid Prozac. At the beginning of 2007 I marked up my calendar with a schedule, I was going to go down from 5ml to 4.90ml the first week, 4.80ml the next week and so on, as my sons would say “epic fail”.  By about mid February the nightmare was unfolding again and I had to give in and go back to the top of my Prozac dose, I was devastated.

Still I hadn’t given up hope, Peter was sympathetic but he couldn’t understand why I didn’t just give it up and accept I “needed” the drugs like a diabetic needs insulin.

After lots more research, and Peter having interesting and enlightening conversations with a client who was a pharmacist about my problem, I started my taper again in May 2008, this time much much slower and here I am four years later down to 1ml liquid Prozac and still tapering. It has needed a lot of self-discipline. I kept a blog of my progress; I’ve been amazed to meet a few others who have been tapering longer than me.

My blog gradually opened up a whole world of people to me, and many heartbreaking stories of careers ruined, relationships broken and lives destroyed through these drugs. Seems I got away relatively lightly. Every time I hear a story on the news about a high school shooting, the shootings in Cumbria, violent suicides I wonder what the “hidden” story is. There is a huge assumption that these drugs are benign and harmless, they are not; they can cause extreme agitation and internal torture. They are dished out like smarties and people left to deal with the results. Starting them is like playing a game of Russian Roulette, you might be a lucky one who can take them and come off them with ease, or you might not. My understanding was that they were meant to be taken for only a year or so after you feel “well” but many many people are stuck on them for years or forever, I know many people who’ve given up hope of coming off SSRI’s and I hear many people say “oh I’ll be on these the rest of my life”. There is NO support or advice in place through doctors or psychiatrists on how to taper safely off the drugs.  I know Bob has been looking for it as well and has yet to find it....if anyone does find any help in the UK, please let me know, although it’s a bit too late for me now as I’ve almost done it myself bar the last 0.90ml but I know a lot of other people who might like to know!

Thanks Bob for inviting me to write a guest post here, huge admiration for the work you do, keep on keeping on!

----

Sheila's blog can be read HERE





Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE



Thursday, May 24, 2012

Antidepressant Use in Children




Antidepressant use in children.

It's a no-brainer.

Same as it is with adolescents and adults too.

Two videos to watch.






Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE




Tuesday, April 17, 2012

SSRI Completed Suicides



There's been much talk lately as to whether or not there is evidence that SSRi's can actually cause a patient to take their own life. For me, at least, the answer to the question is a no-brainer.

RxISK now has a searchable database where one can research just how many suicides are associated with prescription medication. The information was gathered from the FDA.

Citalopram [Cipramil, Celexa]
1,161 completed suicides.
447 suicide attempts
423 suicidal ideation [thoughts about suicide]

Escitalopram [Lexapro, Cipralex]

841 completed suicides.
472 suicide attempts
623 suicidal ideation

Fluoxetine [Prozac]

919 completed suicides.
457 suicide attempts
540 suicidal ideation

Paroxetine [Paxil, Seroxat, Aropax]

2,273 completed suicides.
1,886 suicide attempts
3,643 suicidal ideation

Sertraline [Zoloft, Lustral]

776 completed suicides.
585 suicide attempts
816 suicidal ideation

Venlafaxine [Effexor] *SNRi

1,117 completed suicides.
797 suicide attempts
1,233 suicidal ideation



The field of psychiatry and medicine regulators, including the FDA, will tell you that the benefits of taking SSRi-type medication outweighs the risks, some psychiatrists actually still deny there are suicidal risks associated with antidepressants. The 'risks' aren't just suicide, suicidal thoughts or attempts. There's a whole host of risks...but they all are apparently outweighed by the benefits.

What exactly are the benefits and how can anything that carries a risk of death be deemed 'beneficial'?

The above figures are just those that have been reported, many go unreported because loved ones left behind don't make the connection partly because the key opinion leaders in the field of psychiatry claim there is no link to antidepressant use and suicide.

Key opinion leaders are just that. They lead the field with their opinions and many doctor's look to their published papers as a useful resource tool before prescribing these drugs.

Reading the statistics above one would feel that it's hard evidence and that it should serve as a stark warning to prescribers. One would think...




RxISK can be found HERE











Monday, February 27, 2012

Leeds 1983 - The Hidden Zoloft Clinical Trial



Far be it from me to promote David Healy but his latest posts on his blog have certainly left food for thought.

Yesterday I wrote about one of the two published papers from Healy with regard to the safety and efficacy in antidepressant medication, a paper that should be downloaded, printed and shown to healthcare professionals next time you visit their surgeries.

Today sees Healy write about an early clinical trial for Zoloft [sertraline], a trial from 1983 that was undertaken in Leeds, UK.

He writes:

There were 12 female volunteers aged between 34 and 40. The study was supposed to randomize half to sertraline and half to placebo for a week followed by a cross-over between drugs. It was abandoned before the first week was out.

And why was the trial abandoned?

Side effects.

So, back in 1983 Pfizer learned that Zoloft could cause  apprehension, insomnia, movement disorders, tremors and akathisia, what did they do about it?

Nothing.

The study was never published but Healy got to hear about it in 1998 from Ian Hindmarch, the doctor who ran the trial. Hindmarch went on to conduct another Zoloft trial in later years, this time the patients were given much lower doses of Zoloft resulting in more favourable results for Pfizer. That particular study, unsurprisingly, was published but very little is known about the Leeds study...until now.

Healy, who has had access to Pfizer's archives, also notes that, "...many years before these drugs triggered tens of thousands of suicides and acts of violence, was a great deal of evidence outlining the nature of the problem and their understanding of it."


The British drug regulator should investigate but they are probably too busy writing to doctors about SSRi specialists...that don't exist.

I'm not alone in thinking that pharmaceutical companies do everything in their power to make the 'perfect product' - trouble is...they don't pull it if it's not perfect, they simply hide the fact that it's defective.

The 7 women who received doses of Zoloft in the 1983 study may still be alive today. According to Healy these women would now be between the ages of  61 and 69 and may still be living in or around Leeds.

Wouldn't it be interesting if these women came forward. Where are the media when you need them, eh?

Healy's post, Mystery in Leeds, can be read HERE



Fid


ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE


AUSTRALIAN ORDERS HERE






Wednesday, September 07, 2011

Anxiety UK Charity - Astroturfing?

Anxiety UK - Astroturfing?


An astute Seroxat Sufferers regular, Ruth, emailed me earlier with a charity she had stumbled across whilst researching. That charity is Anxiety UK.

Anxiety UK's 'About Us' page proclaims that it is a national registered charity formed 40 years ago by a sufferer of agoraphobia for those affected by anxiety disorders. It continues with:

Today we are still a user-led organisation, run by sufferers and ex-sufferers of anxiety disorders, supported by a high-profile medical advisory panel.
 All fine and dandy then. I have much respect for patient support groups...but a high-profile medical advisory panel?


The panel, which consists of medical advisers and patrons, throws up some names with interesting backgrounds in the field of psychiatry.

Top of the list is Professor David Clark. The Anxiety UK page describes him as thus:

Born in Darlington, England. He studied Experimental Psychology at Oxford University. His clinical training was at the Institute of Psychiatry, Kings College, London in Clinical Psychology. He was a lecturer in Clinical Psychology and Professor in Psychiatry research fellow at Oxford University.

A quick Google search shows that Clark is a firm believer in Cognitive therapy versus the use of medication. His co-authored paper, 'Cognitive Therapy Versus Fluoxetine in Generalized Social Phobia: A Randomized Placebo-Controlled Trial.' [1] found that Cognitive therapy is more effective than fluoxetine in people with generalised social phobia.

A decent approach but it leaves me somewhat baffled why Professor David Clark sits on a panel of a charity that directs readers of its website to Pfizer and Lundbeck?

"Generalised Anxiety Disorder" [GAD], writes Anxiety UK, "can be defined as a disorder in which the sufferer feels in a constant state of high anxiety and is often known as ‘chronic worrying’ or a ‘free floating’ anxiety condition."


Anxiety UK's GAD information page goes one step further, it would appear that they are cutting out the middle man [Doctor] as they offer you a self-assessment on their page.

If you can answer YES to most of the questions it is likely that you are affected by GAD.
During the past 6 months:- 

Do you feel that you have been nervous/on edge most days over the past 6 months?
Did you have problems falling asleep
Did you feel tension in your muscles because of feeling on edge?
Did you frequently feel tense and irritable? 

Anxiety UK strongly advises that people seek further information and guidance from their GP who will be able to make a formal diagnosis.

I cannot imagine for one minute that your average doctor would recommend Cognitive Therapy to any patient who had answered 'Yes' to most of the above questions. A prescription would more than likely be written for a medication that apparently can help with this 'disorder'.

The conveyor belt 


Fear not, even if you, like me, feel that medication can cause more harm than good, Anxiety UK are on hand to offer you more information. They do this by stating:


Want to know more?


The Anxiety UK site has information on a range of resources to provide more detailed information and help.

And that help directs you into the bowels of the pharmaceutical industry, whose main objective is to sell you drugs.

Here's a snapshot of Anxiety UK's GAD page:



Whilst I applaud the efforts of Professor David Clark to show that Cognitive Therapy works better than Prozac, I'm left scratching my head why he would wish to remain on a panel of a charity that directs its members to two pharmaceutical companies who manufacture drugs that, miraculously, can cure the very same symptom [GAD] that you have self-assessed yourself with.


Anxiety UK's medical advisers and patrons include:

Professor Cary Cooper CBE - Who is the author of over 100 books on occupational stress, stress medicine and industrial and organizational psychology.

Professor Robert Edelmann - Whose main research interests relate to chronic blushing.

Dr David Baldwin - Whose research interests include the clinical psychopharmacology of anxiety and depressive disorders and the prevention of suicidal behaviour.

I find myself wondering why Baldwin would be part of such a charity that directs members to Pfizer and Lundbeck, both have drugs known to cause suicide.

Pfizer's Sertraline, whose brand names are Zoloft and Lustral, has been reported to cause severe withdrawal problems, suicide and, some quarters now believe, birth defects.

Lundbeck's citalopram and escitalopram, whose brand names include Cipramil, Celexa, Lexapro and Cipralex, have all been associated with suicide, homicide, withdrawal problems and many believe, birth defects. More on Lunbeck and citalopram HERE.

Do you, like me, find it odd that a charity, with esteemed professionals as its medical advisers, would endorse the above pharmaceutical companies, or at least direct it's members to gain more information from these pharmaceutical companies?

With this in mind I contacted Anxiety UK early this morning with the following:


Dear Anxiety UK,


I am the author of the paperback, The evidence, however, is clear...the Seroxat scandal and also the blog, Seroxat Sufferers Stand Up And Be Counted.


An astute reader of mine recently alerted me to your page where I learned that you are directing readers/members to two pharmaceutical companies, namely Pfizer and Lundbeck, for 'recommended reading'


Question:


Why are you directing readers/members to two pharmaceutical companies whose antidepressant drugs are the subject of withdrawal problems, suicide ideation and birth defects?

By 5pm UK time, Anxiety UK had not responded.


Footnote:

In 2006 Pfizer announced that the European Commission has approved Lyrica [pregabalin] for the treatment of generalized anxiety disorder [GAD] in adults.

In early 2010 Pfizer announced that the Food and Drug Administration [FDA] issued a Complete Response letter regarding the company's New Drug Application [NDA] for Lyrica [pregabalin] capsules CV as a monotherapy treatment for generalized anxiety disorder [GAD]. The FDA determined that the data contained in the NDA were insufficient to support approval.

The registrant of Anxiety UK is listed as The National Phobic Society. Their website, aptly entitled, "No More Panic" also offers help of the medication kind.

So, are Anxiety UK an astroturfing group? If not, why are they directing its readership to two pharmaceutical companies, with a history of manufacturing drugs known to cause suicide?

It's medical advisers may wish to reconsider their position on Anxiety UK's panel, I know I would.







[1] Cognitive therapy is more effective than fluoxetine in people with generalised social phobia


Fid 


ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING 


AUSTRALIAN ORDERS HERE



Thursday, July 28, 2011

Psychiatric Drugs - Even Psychiatry Isn't Sure.




A recent article on the CNN Health web page asked the question, Is it OK to be on antidepressants for years?

The answer, given by a psychiatrist, should embarrass those that manufacture these drugs, it should embarrass those that regulate these drugs. It should embarrass those that continue to prescribe these drugs.

Dr. Charles Raison, an associate professor of psychiatry and behavioral sciences at Emory University, and an expert in the mind-body connection for health.


Ten years ago my answer to this question would have been, "Certainly not."

A year ago my answer would have been, "Almost certainly not."

Now, unfortunately, the most honest answer I can give you is, "I'm not sure."

Coming from a guy who has treated thousands of people over the years with antidepressants, I have to admit that my uncertainty both shocks and distresses me.

I should probably get over my sense of shock. One of the glories of science is that it keeps moving forward, and as it does so, it usually sweeps old certainties into the dustbin.

Psychiatry's commitment to the unqualified goodness of antidepressants is one of those old certainties. That I'm distressed is understandable.

Dr Raison's full response HERE

If you put all the pieces of the jigsaw together, the picture becomes so much clearer folks.

Now watch the video:





Fid


ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
US & CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE 
 




Sunday, June 12, 2011

Researchers Seek Prolonged Antidepressant Withdrawal Cases



An Italian researcher is collecting case reports of prolonged antidepressant withdrawal syndrome for important research papers now in progress. Something that should have been done by the pharmaceutical companies and medicine regulators years ago!

Please send your case report immediately -- instructions and an e-mail address are given below. Reports may be in English, French, Spanish, or Italian.

The research effort is led by Dr. Carlotta Belaise, a colleague of Dr. Giovanni A. Fava and frequent co-author with him of scientific papers challenging the long-term use of antidepressants.

Dr. Belaise is a research fellow in the Affective Disorders Program of the department of psychology at the University of Bologna in Italy. Her research team is collecting data on antidepressant withdrawal syndrome, "which we strongly believe is a very important, common and delicate clinical problem."

"A couple of manuscripts on this important issue are in progress."

Please send your case report immediately in this format:

Your pseudonym (to use if your report is published)
The date of this report
Your current age
Gender (if female, menopausal?)
Psychiatric drug history
When and how did you taper off each medication?
Your symptoms in the earlier phase of withdrawal
Your current symptoms
Which symptoms have gotten better? Which have gotten worse? What treatments have been helpful?
Is there anything else you would like to say about withdrawal and withdrawal syndrome?


Your identity will remain confidential. Researchers may contact you through your e-mail address for clarification, if necessary, and possibly for longitudinal follow-up periodically to track your recovery. Your e-mail address will not be used for any other purpose.

Send your e-mail HERE

HAT-TIP: SURVIVING ANTIDEPRESSANTS FORUM

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

US/CANADA COPIES HERE 
UK/IRELAND FROM CHIPMUNKA PUBLISHING 

Please contact me if you would like a guest post considered for publication on my blog.