"It's not about what they tell you, it's about what they don't."
~ Bob Fiddaman, Author, Blogger, Researcher, Recipient of two Human Rights awards
Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Showing posts with label Off-Label. Show all posts
Showing posts with label Off-Label. Show all posts
Monday, June 19, 2017
UK Figures See Rise in Antidepressant Use in Under 18's
Data obtained from The Guardian newspaper has revealed that over 166,000 consumers under the age of 18 were given antidepressant medication between April 2015 and June 2016, including 537 aged six or under.
These figures really shouldn't shock and are, more than likely, underestimated. Quite why the Guardian is only revealing statistics for those 18 and under is a mystery. The current recommendations is for antidepressants not to be used in treating anyone 24 and under - so we have a absence of data here.
To offer balance, albeit in the form of professionals with links to the pharmaceutical industry, the Guardian quoted David Taylor, who is a spokesperson for the Royal Pharmaceutical Society. He claimed, “Antidepressants are only used in children in circumstances where there is clear support from robust clinical trials. Adolescents with anxiety, obsessive compulsive disorder and post-traumatic stress disorder may be prescribed antidepressants, and fluoxetine is used in depression.”
Robust clinical trials?
Where are those 'robust' clinical trials he refers to?
Offering balance, Dr Antonis Kousoulis, a clinician and assistant director at the Mental Health Foundation, said the figures show “we are failing to provide a choice of age-appropriate psychological treatments at the point of the need”. He continued, “GPs over prescribe antidepressants often because of the long waiting lists for specialist services,” adding. “But the evidence that these medicines are effective in children is not as comprehensive as is it for drugs for other conditions.”
Surely we can't use long-waiting lists for psychological treatments as an excuse to put children and adolescents in danger?
The National Institute for Health and Care Excellence (NICE) also weighed in with, "antidepressants should be given only to teenagers and children with moderate or severe depression."
This goes against the recommendations of both the manufacturers of these drugs and the limp-wristed regulatory agency who claim to protect the public from harm from unsafe drugs.
NICE also claimed, "Fluoxetine (Prozac), which is sold under the trade name Prozac, is the only drug recommended for younger people, but other medication can be used as second-line treatment if fluoxetine does not work."
Really, other medication can be used?
I've long had a beef about the word 'recommendation'. In a blog post of mine from 2014, "Not Recommended", I highlighted how this term is, in essence, nothing more than a legal requirement. It protects the pharmaceutical industry and the regulator because they can always claim, after an antidepressant-induced death that, they have both warned about antidepressant use in this age group. It covers them legally and the only ones left to blame are the prescribing doctors who, in their defence, will claim there's a long waiting list for psychological treatments so "I had to prescribe something."
What they are prescribing are a series of mind-altering drugs known to cause suicidal feelings and, in many instances, suicidal completion. With comments and advice from the likes of NICE, the Mental Health Foundation, and the Royal Pharmaceutical Society doctors in the UK must be as confused as I.
It's crystal clear, to me at least, that the warning needs to change. "Not recommended" needs to be dropped and replaced with “must not be used” in children and adolescents.
Of course, it would be too much to ask the British drug regulator (MHRA) to come out and oppose the prescribing of these drugs to kids. Recent communications between the MHRA and myself shows MHRA wants citizens to pay them for information regarding suicides in SSRI clinical trials - see MHRA Seek Payment For Info on Deadly Drugs.
If a regulator is reluctant to release the full information about these drugs then what hope do doctors have when deciding whether or not they are safe? Oh, I know, the "not recommended" cop out!
What is startling about these recent figures is that 537 consumers, aged six or younger, were prescribed these mind altering drugs. But don't expect any response other than, "We have warned practitioners that these groups of meds are not recommended for this age group."
The Guardian article can be read here.
Bob Fiddaman
Tuesday, July 15, 2014
Not Recommended
People that know me pretty much know that the words 'not recommended' mean absolutely nothing to me.
When used on drug information leaflets, 'not recommended' serves as a reminder to prescribing physicians that the drug they are about to prescribe to the patient is not recommended for them, be it because they don't have an illness that the drug is indicated to treat or that it could be potentially dangerous.
Last week British tabloid, The Mirror, ran with an article about pensioner Ron Sheppard.
Sheppard had been campaigning for almost 22 years to force changes to the way a steroid [Depo-Medrone] was used on millions of patients. And now, writes The Mirror, "drug company Pfizer has applied to UK drug regulators to change the drug labelling.
"It is likely to be switched from “not recommended” for use in epidurals to “must not be used”."
22 years on and now Pfizer decide that the drug must not be used in epidurals. It would appear that Pfizer know the difference between “not recommended” and “must not be used”, either that or they fear future lawsuits.
“Not recommended” is simply not good enough, particularly when it comes to children being prescribed antidepressants.
Would it be practical for the likes of antidepressant manufacturers to change the patient information leaflets for antidepressants from 'Not recommended for children' to 'Must not be used in children'?
The defence of the pharmaceutical industry has, for many years, been this 'not recommended' nonsense.
"It specifically states that our product is not recommended for use in children", is a line thrown around when pharmaceutical products have been implicated in child/teen suicides. Hidden in their defence, however, are facts that they have promoted the use of antidepressants in children - reps, armed with cash incentives or other lavish gifts have, for decades, persuaded doctors that "not recommended" are just two words that have to appear on leaflets for legal reasons. A rep from Glaxo would have told doctors that Paxil was safe to use in kids...it was the other SSRi's that were unsafe. A rep from Lundbeck would have told doctors that Celexa was safe to use and that it was other SSRis that were dangerous.
That's how marketing works and it was those two words that allowed pharmaceutical companies to get away with it for decades.
If a rep had visited a doctor and offered him cash incentives to prescribe a drug that said “must not be used”, would the outcome have been the same?
"Not recommended" can be written off as a legal requirement, it can be a discussion starter with a pharma rep and doctor, it can be twisted to convince the doctor that it's okay to prescribe adult drugs to children or drugs with a link to birth defects to pregnant mothers.
It's time to change all of that.
The following “must not be used” in children, adolescents and pregnant mothers.
Citalopram
Fluvoxamine
Escitalopram
Paroxetine
Sertraline
Fluoxetine
They “must not be used” to treat illnesses other than those indicated on the leaflet.
It doesn't take a rocket scientist to figure out why this has never been done.
'Not recommended' has helped the pharmaceutical industry get away with murder and, at the same time, earned them billions of dollars. Money over life.
Just a small example here.
Bob Fiddaman.
Sunday, June 29, 2014
Health Canada Secrets and Birth Defects
Canada's medicine watchdog, Health Canada, are in the news once again.
Last week it was reported that Health Canada were refusing to release its own internal report on the state of a GlaxoSmithKline plant in Quebec.
The American medicine regulator, the FDA, had previously found bacterial contamination problems and had raised concerns about the purified water system at the plant. Health Canada carried out their own inspection but refused to release their findings [Health Canada Refusing to Release Glaxo's Dirty Secret]
Coming on the back of this is news is a report that Health Canada are also refusing to publish data on off-label drug side effects.
In a revealing editorial in The Star, David Bruser, Jesse McLean and data analyst Andrew Bailey report that Health Canada have been collecting the adverse reaction reports but refusing to publish them on the grounds that "It’s been collecting this information for six years but technical limitations with the database have prevented the public release."
"Indeed, the Star analyzed the information collected in the FDA database and found nearly 400 off-label cases from 2010 to 2013 that involve a range of side effects ranging from death to heart attacks, strokes, birth defects and organ failure.
"In Canada, the federal regulator collects the same information but removes the off-label details before publishing its side-effects database. Without this information, doctors and patients can’t ask the proper questions. It’s an offensive lack of transparency."
Dr. Joel Lexchin, one of Canada s leading authorities on drug safety, says, “There are significant public safety implications. This is a major problem for doctors and patients alike.”
Health Canada must publish this information and they must do it now. They have no right to keep this information from the public or health care professionals.
If evidence was needed as to why playing God has implications then one only has to read the latest news coming out of Canada regarding a powerful anti-nausea drug being prescribed to women who are pregnant.
Zofran [ondansetron] has been approved by Health Canada to treat nausea and vomiting in chemotherapy and surgery patients but it has never been approved for use in pregnancy. However, like most drugs, Zofran is being prescribed in this population off-label.
The Star are reporting...
"At least 20 Canadian women treated with ondansetron for vomiting in pregnancy experienced serious suspected side-effects, including two infant deaths and multiple cases of newborns with heart defects and kidney malformations."
Back in 2013 I was contacted by Tomisha LeClair. She informed me that she fell pregnant in 1999 and like many women developed nausea and vomiting and was prescribed Zofran.
At seven months gestation Tomisha was given an ultrasound and was told by doctors that her unborn daughter had a renal cyst; a fluid filled sac on one of her kidneys. The medical staff explained there are many children born with this complication and if necessary she could be treated with antibiotics upon birth.
She told me:
In the latter part of 2000 I wrote to the (FDA) the Food and Drug Administration to complete a Med-Watch form reporting my daughter’s “abnormalities”. I initiated a (FOIA) a Freedom of Information Act request to the Food and Drug Administration inquiring about the adverse reactions reported by other patients who had also been prescribed this drug, to compare them to Ahjanee’s abnormalities. My suspicions were that the “wonder drug” had caused Ahjanee’s abnormality’s. Several weeks later I received a 20 page alphabetical list of all the reported adverse reactions reported by other patients, compiled into percentiles.
She added...
The "adverse reaction" list from the FDA is 26 pages long and contains every "abnormality/anomaly" my daughter and many of the other children have.The Center for Drug Evaluation and Research (CDER) Report is alarming to say the least! If I had to be scientifically specific regarding what Zofran has caused within the children, I would say that Zofran prescription during pregnancy causes clusters of symptoms such as cranial abnormalities; my daughter has microcephaly [Fig 1], and another child hascutis cutis aplasia (characterized by the absence of a portion of skin in a localized or widespread area at birth), and there is one more cranial/skull abnormality that I can't recall by name. One child has Ebstein anomaly (a congenital abnormality that is present from birth and affects flaps that make up the tricuspid heart valve) and another has Hirschsprung syndrome (missing nerve cells in the muscles of part or all of the baby's colon) and another has clubfoot.[Fig 2] - [See Are GSK Concerned About the Zofran Noise?]
Fig 1
Fig 2
Zofran is manufactured and marketed by GlaxoSmithKline.
Are we really surprised anymore?
In Canada the generic version of Zofran is sold by Mylan.
What exactly are Health Canada playing at here?
I thought you'd have to go a very long way to beat the ineptitude of the MHRA and FDA...Health Canada have beaten them in the Stupidity Stakes by a number of lengths!
For more information on Zofran birth defects visit MA'Z (Mother's Against Zofran Birth Defects), a Facebook community page created by Tomisha LeClair.
Bob Fiddaman
Thursday, June 26, 2014
Hey Glaxo, Guess Who's Been Talking?
GSK Whistleblower Blair Hamrick & Bob Fiddaman
I started writing this blog back in 2006. I had some issues with the antidepressant drug manufactured and marketed by British pharmaceutical giant GlaxoSmithKline. I also had some issues with the way drugs were regulated in this country by the British drug regulator, the MHRA.
Eight years on and I have learned so much about GlaxoSmithKline... I learned more about them yesterday evening as I sat down to dinner with Blair Hamrick, one of the whistleblowers who blew the lid on Glaxo's fraud in the US, a blow which, after 11 years of legal wrangle, Glaxo settled for a record breaking $3 billion.
Blair is a very brave soul for going up against the company that he once worked for. His life is now back on track after Glaxo sacked him then muddied the waters so he couldn't get a job elsewhere in the pharmaceutical field. Yes, he was paid handsomely for his bravery and is now living a life that most could only dream of.
Despite the publicity, fame and riches Blair is one of the most down to earth people you could ever wish to meet, a trait that became evident when he just couldn't bring himself to promote the antidepressant Wellbutrin off-label to doctor's.
Wellbutrin is an antidepressant and indicated to treat adults that are depressed. Blair, whilst working for GSK, was prompted by senior management to promote it off-label to doctors for treating children. He just couldn't bring himself to do that. One of the side effects of Wellbutrin is seizures and Blair envisaged kids going into seizure. "It was wrong, it wasn't indicated for kids and I just couldn't bring myself to tell doctor's it was okay for kids to take," Blair told me over a glass of wine in the plush settings of one of Westminster's finest hotels in London. "They also tried to market it as the happy-horny-skinny pill because they had learned through post marketing that patients taking it for depression were losing weight and reporting high sex drives." [increased libido] Wellbutrin was not indicated for this but the Glaxo marketing team came up with the "happy-horny-skinny pill" line so reps could convince doctors to prescribe it to patients who were overweight and also those who were experiencing a low sex drive [decreased libido]
Wellbutrin is an antidepressant and indicated to treat adults that are depressed. Blair, whilst working for GSK, was prompted by senior management to promote it off-label to doctors for treating children. He just couldn't bring himself to do that. One of the side effects of Wellbutrin is seizures and Blair envisaged kids going into seizure. "It was wrong, it wasn't indicated for kids and I just couldn't bring myself to tell doctor's it was okay for kids to take," Blair told me over a glass of wine in the plush settings of one of Westminster's finest hotels in London. "They also tried to market it as the happy-horny-skinny pill because they had learned through post marketing that patients taking it for depression were losing weight and reporting high sex drives." [increased libido] Wellbutrin was not indicated for this but the Glaxo marketing team came up with the "happy-horny-skinny pill" line so reps could convince doctors to prescribe it to patients who were overweight and also those who were experiencing a low sex drive [decreased libido]
Blair also spoke about the doctors who were paid by GlaxoSmithKline, a staggering 48,000 doctors were paid speaker fees, attendance fees and given lavish gifts, all in an attempt to get them to prescribe more of Glaxo's drugs.
"We'd pay doctor's between $2-4000 to give a talk to other doctor's.
"6 or 7 doctors would be invited out for dinner, sometimes with their spouses in tow, they'd be wined and dined and then the speaker would talk about the wonders of drug a or b, of course these were off-label "wonders" - that's how Glaxo rolled.
"Our marketing team would send them a slide-show and a carefully scripted narrative so they could convince other doctor's that it was okay to prescribe a number of drugs off-label.
"Some doctor's, whose basic annual salary was around $150,000, could give 2 or 3 talks in a week, giving them a potential to earn up to an extra $12,000 per week.
"I was also given luxury private box tickets for sporting events, these would be given to doctors as a 'thank-you' or incentive to prescribe more and more of Glaxo's drugs."
Glaxo, at some point during these wanton violations, caught wind that their off-label promotion had been leaked and reps were told to be careful what they added to their call-notes.
Call-notes are what pharmaceutical reps use to familiarize themselves with a doctor.
Call-notes are what pharmaceutical reps use to familiarize themselves with a doctor.
"The way it worked was that a doctor would be visited by a rep who would then add notes to a hand-held device.
"It was useful because we knew what these doctor's liked, be it a particular football, baseball team or if he had a sweet tooth - on the next visit we would bring in a small token of gesture, be it tickets to the game or sweet tasting delicacies - it was just a way to keep them prescribing more drugs."
Blair recalled a meeting where reps were told to be careful what they wrote in the call-notes, the crux of the meeting was basically to tell reps to "write right", in other words write down the legal stuff and not the violations.
I asked Blair about Glaxo's recent announcement that they are going to be more transparent.
"The whole transparency thing wasn't a conscious decision by Glaxo, their hand was forced, it was all part of the settlement - it makes me laugh when I now read how they are claiming to offer up the results of their clinical trials, they were told that's what they had to do as part of the agreement they entered into with the Department of Justice."
Regular readers of this blog will note the tagline I use, "It's perverse when GSK claim that they are going to be more transparent when they do not offer transparency when writing about their transparency."
I could have listened and talked to Blair all night, alas I had a train to catch back home, a train that I almost missed due to losing track of the time.
Blair Hamrick, along with the other whistleblowers in this particular case, should be applauded for their efforts. It's no coincidence that Glaxo are now being investigated for the same type of violations in other countries.
Blair Hamrick, along with the other whistleblowers in this particular case, should be applauded for their efforts. It's no coincidence that Glaxo are now being investigated for the same type of violations in other countries.
Blair blew the whistle and it almost took the roof off GSK, for that he deserves a future of happiness. His conscience not to promote a drug that could cause kids to have seizures was frowned upon by senior management at GSK - what kind of human being could promote a drug that could be potentially harmful to children, moreover, what type of human being could sanction such a promotion?
On a side note, I wasn't just in London yesterday to meet Blair. Earlier on I met with a film-maker who is in the process of making a documentary about antidepressants. The film-maker also dined with myself, Blair and his partner. More about the documentary in a future post.
I now have something to tell my grandchildren.
I once had dinner with Blair.
On a side note, I wasn't just in London yesterday to meet Blair. Earlier on I met with a film-maker who is in the process of making a documentary about antidepressants. The film-maker also dined with myself, Blair and his partner. More about the documentary in a future post.
I now have something to tell my grandchildren.
I once had dinner with Blair.
Bob Fiddaman
Monday, June 23, 2014
Critics Slam New Antidepressant-Suicide Study
A new study has recently been slammed by fellow professionals in the field of medicine and a top US law firm.
The study, "Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study", was published in the British Medical Journal [BMJ ] last week and, basically, makes outrageous claims based on findings that seem to be based on bizarre methodology.
I had to look up the word 'quasi' as I didn't know what it meant. I'd assumed for many years it was a shortened version of Quasimodo [ The Hunchback of Notre Dame]
The authors have, it would appear, cherry-picked studies in an attempt to manipulate the outcome.
In a nutshell the authors are suggesting that teenage suicide increased after the FDA toughened antidepressant warning [Black Box Warning]
Two things strike me here.
1. The BMJ is widely read by doctor's, many of whom have been fence-sitting for years regarding the off-label prescribing of antidepressants to children and adolescents. This study is the proverbial splinter up the backside for those doctors, with a sharp prick to the the buttocks they fall from their fence on to the side of the pro-antidepressant brigade.
2. The media reporting of this particular study is worrying. Retired psychiatrist Mikey Nardo, who writes the 1 Boring Old Man blog, breaks the media coverage down...
First the Washington Post (Dennis) reports:
As a result [of the FDA warnings] antidepressant prescriptions fell sharply for adolescents age 10 to 17 and for young adults age 18 to 29. At the same time, researchers found that the number of suicide attempts rose by more that 20 percent in adolescents and by more than a third in young adults.
Comment from a non-study affiliated expert? YES
How many limitations are discussed? NONE
According to NBC News (Raymond) :
New research finds the warning backfired, causing an increase in suicide attempts by teens and young adults. After the FDA advisories and final black box warning that was issued in October 2004 and the media coverage surrounding this issue, the use of antidepressants in young people dropped by up to 31 percent.
Comment from a non-study affiliated expert? NO
How many limitations are discussed? NONE
Reuters (Seaman) reports that:
Antidepressant use decreased by 31 percent among adolescents, about 24 percent among young adults and about 15 percent among adults after the warnings were issued. At the same time, there were increases in the number of adolescents and young adults receiving medical attention for overdosing on psychiatric medicines, which the authors say is an accurate way to measure suicide attempts. Those poisoning increased by about 22 percent among adolescents and about 34 percent among young adults after the warnings. That translates to two additional poisoning per 100,000 adolescents and four more poisoning per 1,000 young adults, the researchers write.
Comment from a non-study affiliated expert? YES
How many limitations are discussed? ONE (limitation #5)
According to USA TODAY (Painter):
Warnings that antidepressant medications might prompt suicidal thinking in some young people may have backfired, resulting in more suicide attempts, new research suggests.
Comment from a non-study affiliated expert? YES
How many limitations are discussed? NONE
Forbes (DiSalvo) reports:
Antidepressant use fell 31 percent among adolescents and 24 percent among young adults after the FDA warnings, according to the study. Suicide attempts increased by almost 22 percent among adolescents and 33 percent among young adults in the same time period. Suicide attempts tracked in the study were largely the result of drug overdoses.
Comment from a non-study affiliated expert? NO
How many limitations are discussed? NONE
NPR (Stein) also reports on the story:
Antidepressant use nationally fell 31 percent among adolescents and 24 percent among young adults, the researchers reported. Suicide attempts increased by almost 22 percent among adolescents and 33 percent among young adults.
Comment from a non-study affiliated expert? YES
How many limitations are discussed? ONE (limitation #5)
Finally, the Boston Globe (Freyer) concludes that...
instead of declining as hoped, suicide attempts over the next six years showed a “small but meaningful” uptick among people ages 10 to 29, according to a study published Wednesday in the journal BMJ. That increase followed a substantial drop in the use of antidepressants.
Comment from a non-study affiliated expert? YES
How many limitations are discussed? NONE
A perfect proxy for advertising the safety of antidepressant use in kids.
The study, which is open to opinion has, thus far, received a number of comments from fellow-professionals.
Gerald W Gaines, who owns Depression Recovery Centers in Arizona, writes...
" The study presents a statistical association and proposes a causal relationship with no proof and three key assumptions that anti-depressants have efficacy, increases in overdose were due solely to suicide attempts and the two were somehow linked. The study does not demonstrate causality and the preponderance of secondary evidence would suggest there is no causality at all in the way implied."
Worryingly Gaines uses the horse tranquilizer Ketamine to treat his depressed patients.
Peter C Gøtzsche of the Nordic Cochrane Centre in Denmark is highly critical of the study...
"The FDA’s large meta-analysis of 100,000 patients who had participated in placebo-controlled randomised trials found that antidepressants increase suicidal behaviour up till about the age of 40, and in young people, the risk was doubled"
He adds, "The findings in the report by Lu et al. should be ignored. SSRIs don’t decrease suicidal behaviour in young people, as they claim. SRRIs increase it, and it seems that the risk increases with dose, as would be expected."
Associate Professor, Dept. of Family Medicine, McMaster University Dee Mangin, hits the nail on the head with...
"Almost none of these drugs are licensed for use in depression in this age group. This article could by its implications endorse off-label use."
Psychiatrist Bernard J Carroll of California adds input to the controversial study with, "I won’t even bother to critique the special pleading and the tendentious tone of this report. The decision to publish it was not the BMJ’s finest hour."
While David Healy, Professor of Psychiatry Bangor University, adds, "There is in summary so little basis in the data presented here for the argument being made that this paper perhaps offers better evidence of an agenda than anything else."
It's a pity the mainstream media chose not to ask any of the above professionals for their expert advice, opting instead for sensationalism and eye-catching headlines.
The lead author [instructor] of the study is one Christine Y Lu.
Lu is a a pharmacist, pharmacoepidemiologist, and health policy researcher. She also mentors students and fellows through the Harvard Medical School Fellowship in Pharmaceutical Policy Research.
Her findings, along with her co-authors, must be a kick in the teeth for the parents who have lost children and other family members to antidepressant induced suicide. Their findings border on moronic given that the methodology used was just a means to widely promote using this group of medications on children and adolescents. At least that's the way I see it... hey I'm an old cynic approaching 50, what do I know?
Even if the study has been criticized they have successfully spread the word without actually lifting a finger.
The BMJ publish it, doctor's read it.
The mainstream press run with it with very few opposing views - the public read it.
Your average family may have been considering their family doctor's offer of an SSRi to help treat their child.
"But don't these drugs cause suicide?"
"No, in fact a new study has shown that suicides have increased since the warning came out... your child is perfectly safe...here's a prescription for Paxil, Zoloft, Celexa, Lexapro, Prozac." [delete where applicable]
I've not yet witnessed a study [so fresh] that has caused so many fellow-professionals outrage. To my knowledge I've never witnessed a law firm come out and chastise the findings of a study so soon after its publication.
Step forward Baum Hedlund, a top US law firm operating out of Los Angeles, Washington, D.C, New Orleans, Philadelphia, and Tallahassee.
They've taken the unusual step of issuing a press release via their webpage.
You can read their full press release here.
In the meantime it's job done for the pro-antidepressant crowd. Their goal may not have been to change the opinion of the FDA, it may have been much simpler. Get the story in a journal widely read by white-coated prescription pad bearers and convince the public [via shoddy journalism] that it's okay to give antidepressants to kids [albeit off-label]
The FDA have issued a statement saying that they have no plans to change the black box warnings [See the Baum Hedlund article for more details.]
Christine Lu has, in my opinion, unleashed a sugar-coated turd. One only has to scratch at the surface to smell the stench. Pinch your nose when going through the study.
Bob Fiddaman.
Labels:
antidepressants,
Baum Hedlund,
BMJ,
Christine Y Lu,
FDA,
Off-Label,
pediatrics,
SSRis,
Suicide
Friday, December 20, 2013
Christmas Message For GSK and Their Attorneys
Christmas message for GlaxoSmithKline and their attorneys, King & Spalding...
HO! HO! HO!
Bob Fiddaman
Labels:
Andrew Witty,
Birth defects,
China,
DOJ,
Fraud,
GLAXOSMITHKLINE,
King and Spalding,
Off-Label,
Paroxetine,
Paxil,
Seroxat
Friday, May 17, 2013
Guest Post: Life ‘at’ and Escape ‘from’ Paroxetine Island
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| The hell of Aropax withdrawal |
Following on from Part I [Like a Lamb to the Slaughter] of Mark's trilogy of guest posts.
This post sees Mark describe the frustrations and hardships of withdrawing from GlaxoSmithKline's Aropax, known in the UK as Seroxat and in the US and Canada as Paxil.
Life ‘at’ and Escape ‘from’ Paroxetine Island [PI]
Life at Paroxetine Island(PI) can only really be described in hindsight and with insight once one has spent time back on the mainland and drug-free. Here are some observations:
- On arrival at PI one has all motivation, passion, spontaneity and confidence taken away and one is given yawning, fatigue and indecisiveness 24/7 in exchange.
- On my 1st night at PI I experienced the most real, horrific and terrifying dream of my life. It involved my death. At the time I was clueless as to what caused this.
- Like creeping mold is to the internal walls of a house in winter so too was paroxetine to my brain. It was a slow, insidious takeover of not just my brain but also my soul. Dulling my emotions and senses, and even when the wallpaper started falling off I was clueless as to the cause.
- My quality of life grew worse and worse, as I became more and more removed from reality.
- Life was sucked out of me and I was no longer living I was simply existing.
- I became a loner and yet I wasn't lonely.
- Much time and effort was spent fighting back evil intrusive thoughts, thoughts that did not belong to me, thoughts that were extraordinarily immoral, offensive and almost audible in my mind beckoning me towards self-destructive behaviour. Thoughts that were demonic in nature.
- Personality and behavioural changes occur on PI perhaps best described as a severing of the conscience.
- Loss of feelings and caring occurred, a total disconnect from reality. The mantra of PI was:
- ‘So what, who cares’! And I was soon singing it.
- An early attempt to break free and swim to the mainland resulted in such psychological, emotional horror and panic I rushed back to my doctor and asked to go back to PI. I was sent back no questions asked.
- Despite promising to never swim away again several more failed attempts to escape left me in a state of learned helplessness, a massive major paradigm shift now occurred in my being. I now believed that I needed to be on Paroxetine Island!
- One day I learned of a person who had escaped from PI and swum back to the mainland. I became very envious, jealous even!
- I was now determined that I too would get back to the mainland. Little did I know that I was about to start a 3-year traumatizing nightmare, a journey through ‘Hell,’ that was going to require every ounce of strength to survive, fighting for my life, daily.
My Escape from Paroxetine Island (PI)
I would like to start by just saying that my escape from PI was the most difficult thing I've ever done in my life. No non-poisoned-by-an-SSRI-brain can conceive, imagine, or understand the traumatising nature of this ordeal.
- I presented to my doctor in January 10, after 10 years use, wanting to get off paroxetine. His reply “okay come off slowly”, and sent me on my way. (Absolutely criminal!)
- I had no idea what slowly was. But decided to start to alternate doses 20 mg one day and 10 mg the next.
- After 6 months I was on 10 mg and in a distraught state.
- The distress drove me to seek counselling, yet it offered no relief. Except lighten my wallet.
- At 9 months and on 5 mg feeling death would be a welcome relief I reluctantly presented to my Doctor (Dr W), only to be told I had an underlying depression and I needed to up dose. At this point I realised Dr W was clueless. I replied, ‘that is not right’. He referred me to a psychiatrist Dr S.B.
- Confused, distraught, frustrated, and in a very dark place, somehow knowing deep down something was not right here but what could it be, I confided in the neighbouring pharmacist. He leaned over and quietly whispered, “Mark I’m not supposed to tell you this but it’s not you it’s the drug”.
- It was like a light switch was flicked, the light bulb went on, I came to my senses. Of course it’s not me, it’s the drug! It was the damn drug! How could I have been so stupid! Words cannot describe the humiliation that started to flood my being followed by anger and disbelief.
- I immediately started digging, and stumbled upon an SSRI addict’s and survivors support group. I realised I had found a place ‘sought by millions but found by few’. I owe my life to them.
- On asking the psychiatrist Dr S.B. if he was aware of any problems with people getting off Paroxetine he replied, “Well if there were problems with people getting off paroxetine people would be suing the drug companies” [I was later to realize this was a Dr who clearly had his initials around the wrong way].
- He also okay’d a Healtheries supplement I wanted to take to try to get some relief. I was sent on my way. I now realised I was on my own.
- I broke free of PI on 28 September 2010.
- The 9 month taper down and the next 2 years drug free was hell. The nightmare I had to suffer (believe me to call it a nightmare is an understatement) coming off this drug had nothing to do with me and everything to do with this drug!
- I wouldn't want my worst enemy to go through this. I was unable to function experiencing daily uncontrollable restless anxiety, endless crying and drug induced suicidal ideations starting from 6 a.m. lasting throughout the day and receding somewhat in the evening. I felt as if I was being psychologically and emotionally raped daily. This withdrawal horror went on for almost 3 years, with the drug induced withdrawal hell pushing me for months to cut my wrists, then for months it tried to get me to hang myself, then it wanted me to shoot myself, and if that wasn't enough drive my car into oncoming traffic. I still remember the day I fought off an overwhelming desire to jump off a bridge.
- These drugs are not given to patients under 18 because they cause suicide …well if my experience is anything to go by they should extend the relabeling ban to those under 50!
- In order to get through this hell alive I dragged several family members so far into emotional overdraft I will never be able to repay them. You can forget being able to hold down a job during this ordeal it’s a battle to just survive each day.
- I so much wanted to reinstate to take the horror away, yet I was driven by a sense of unbelievable anger and humiliation to not do so. Often chanting back ‘it’s not me it’s the drug’ when waves of hell flooded me.
- All I wanted was an opinion on my sore arm, I never consented to this.
- At about 18 months drug free I felt the shark infested waters start to recede, a few months later I washed ashore onto the mainland, exhausted, traumatized and in total disbelief that I was still alive.
- I felt like Rip Van Winkle coming to after being placed in a living coma becoming acutely aware of the damage done to me, waking up in shock and disbelief.
- Let there be no mistake about it, if I was an enemy combatant and the NZ army did this to me, someone would have been dragged to the Hague and jailed for this!
- Hippocratic Oath…..Yeah Right!
- I was determined to get an explanation for this insult to my humanity an answer for something no human should have to endure.
Mark Carter NZ
Coming soon Part III
Bob Fiddaman
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Saturday, May 04, 2013
Guest Post: Like A Lamb to the Slaughter
As this blog grows I get more and more requests from readers asking if they can write a guest post. This has proved very popular and gives a chance for people, patients to vent... none more so than the author of this post, Mark Carter.
As you will learn, Mark is yet another victim of the over prescribing of psychiatric medication, another victim of off-label prescribing.
Mark's story... and this is just part 1 of 3, is nothing new. Thousands, if not millions, of unsuspecting patients are, within minutes, walking out of consultation rooms with pills that are nothing more than loaded bullets. They are being diagnosed with ailments, in Mark's case sore wrists and arms, and then prescribed drugs that have no indication to treat the diagnosis.
This is, sadly, on-going globally.
Mark is from Auckland, New Zealand.
Here's part I of his story.
Like A Lamb To The Slaughter - Part I
I have decided to do a posting for Bobs blog for the following reasons:
1. It’s not acceptable to me, for SSRi’s especially paroxetine [Seroxat, Paxil, Aropax] and including venlafaxine [Effexor] to continue to be on the market.
2. It is my wish that these drugs be exposed for what they truly are; toxins that disrupt and chemically damage the brain and body.
3. I feel morally obligated to communicate to the general public the dangers of these poisons , as I have been grievously injured by taking and subsequently discontinuing them,
4. A dangerous, negligent and appalling level of ignorance from doctors who have thoroughly hoodwinked patients into believing black is white, and from whom no one has a chance of being informed of the truth.
5. I have nothing to hide only devastation to human life to expose
6. If I can stop one person from taking an SSRI or its evil cousins then its been worth it.
It all began in the summer of 2000. In December I presented to an Occupational Specialist Doctor D. with sore wrists and arms from keyboard overuse at my work site.
I was a 37 year old single, cheerful, happy, sports loving, opera chorus singing male. I had never smoked, drunk alcohol, or taken any drugs prior. I also had never had any psychological issues.
I was diagnosed with chronic pain syndrome and given what I now know to be a smorgasbord of poisons.
At the time I was like a lamb to the slaughter, naive, trusting and oblivious to oncoming danger.
I asked the right questions as anyone would, are these addictive, are there any side-effects?
I left assured they were not addictive but may find they give me a dry mouth.
I was also assured they would heal my arm.
Arrived home that day with canisters of amitriptyline, nortriptyline, venlafaxine, and paroxetine . I was told nothing regarding tapering down or not stopping abruptly.
I never felt comfortable with the diagnosis of chronic pain syndrome. The term at the time was repetitive strain injury or occupational overuse syndrome.
I also was filled with dread at being sent back to a job that I clearly could not do any longer. I clearly had an injury in my hand in which pain and an inability to type was amplified when using a keyboard and receded when not using the keyboard.
I was told to take a course of each drug and if no benefit move onto the next one.
I was totally unaware that I was about to expose myself to some of the most dangerous addictive mind-numbing soul destroying potent body damaging chemicals ever manufactured for human consumption.
I was totally unaware of the nature or the toxic effects of venlafaxine and paroxetine.
In hindsight I felt pressured to take these drugs, I mean not taking anything was never a tabled option.
I worked my way through the drugs, on starting the venlafaxine I immediately started getting floaters in my eyes. I was clueless. I also recall being incredibly fatigued, my walking became labored. I rang Dr D at the time from my former work site regarding the struggle to cope and was told to double the dose. Not long after this, my employer, as I could no longer use a keyboard, fired me.
As I no longer had to bare a workload and didn't really want to take drugs I quit cold turkey the venlafaxine, as one would with a so-called non-addictive drug that was doing nothing except fatigue me.
What I didn't know at the time, but I do now, is Dr D had persuaded me to take a sequence of drugs not authorized for use for my injury. He had in fact persuaded me to participate in the off-label use of the drugs and did it by obtaining my uninformed consent.
Shortly after this I started to manifest an uncontrollable anxiety, a kind of psychological panic, a distressed tearful state. There was something clearly wrong with me and something I had never experienced before.
I was clueless as to the cause of this, and thought it may be due to some external stresses at that time.
Concerned I now presented tearful agitated and confused to my family Doctor W of 20 years,… like a lamb to the slaughter. I can still remember my exact words at the time.
“There is something wrong with me, I don’t know what it is, you know me I’m so against the taking of drugs, but do you think I need something for this.”
Without any hesitation, enquiry or diagnostic checklist I was presented with a prescription for paroxetine 20 mg per day and sent on my way assured it was not addictive, safe and may cause a little weight gain.
And that was to be the start of a 10 year drug addiction with a sore arm somehow morphing into a drug induced 'mental illness'.
Stuck on paroxetine-Island only to be met by psychological and emotional shark infested waters every time I tried to leave.
And in addition totally unaware that I was now exposing myself to a slow chemical castration.
Mark Carter - New Zealand
Part II Coming Soon
If you would like to write a guest post then I can be contacted via the 'Contact' tab at the top of this blog.
Bob Fiddaman
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