For a while now I've been at loggerheads with the British drug regulator, the MHRA. (Back stories below)
I've been asking them to send me a detailed list of the benefits of taking Prozac - Yesterday they sent me the following. My response to them follows...
Dear Mr Fiddaman
Apologies for the delay in responding.
Regarding your below enquiry, benefits are considered to be the therapeutic effects of the product to improve the medical conditions for which a product licence has been granted. These are set out as the Therapeutic Indications in the Summary of Product Characteristics (SmPC) and in the uses of the product in the Patient Information Leaflet (PIL). To further understand these benefits, you have asked what positive thing is going to happen to alleviate your depression. The way in which the therapeutic effects are achieved is also explained in these documents. In the case of fluoxetine, it raises the level of the neurotransmitter, serotonin, in the brain which can improve symptoms of depression (and the other indications listed). The MHRA does not promote medicines, but agrees in the SmPC a factual summary of the effects of taking a particular medicine based on the results of clinical and non-clinical studies.
I hope this answers your question.
Best regards The FOI Licensing Team --
My response...
Thank you for this. So, in essence you are telling me that, "In the case of fluoxetine, it raises the level of the neurotransmitter, serotonin, in the brain which can improve symptoms of depression." is the one benefit and that this one benefit has been measured against the risks and the MHRA have granted Prozac a licence because they see that this one benefit outweighs the following reported risks with Prozac use... Please try and help me (and others) understand how one benefit of a product outweighs the following risks associated with Prozac use. All risks taken from the MHRA fluoxetine Drug Analysis Print (DAP) (http://www.mhra.gov.uk/home/groups/public/documents/sentineldocuments/dap_19529665880175380.pdf)
Benefits v Risk
Prozac Use.
Benefits
It raises the level of the neurotransmitter,
serotonin, in the brain which can improve
symptoms of depression
Risks
Blood disorders
Cardiac disorders
Congenital disorders
Ear disorders
Endocrine disorders
Eye disorders
Gastrointestinal disorders
Asthenic conditions
Death and sudden death
Febrile disorders
Feeling abnormal
Feeling jittery
Fibrosis
Gait disturbance
Peripheral swelling
Face oedema
Chest pain
Drug withdrawal syndrome
Hepatic disorders
Immune system disorders
Infections
Exposure during breast feeding
Foetal exposure during pregnancy
Fractures and dislocations
Electrocardiogram QT prolonged
Heart rate increased
Abnormal liver function
Blood sodium decreased
Weight decrease
Weight increase
Blood prolactin increase
Platelet count decrease
Haemoglobin decrease
Blood creatine phosphokinase increase
Blood pressure increase
Blood pressure decrease
Metabolic disorders
Muscle & tissue disorders
Neoplasms
Nervous system disorders
Seizures and seizure disorders
Tremors
Foetal growth complications
Ectopic pregnancy
Foetal death
Abnormal behaviour
Agitation
Anxiety
Nervousness
Aggression
Disinhibition
Homicidal ideation
Hostility
Paranoia
Personality change
Violence-related symptoms
Confusion and disorientation
Delusion
Depression
Depersonalisation/derealisation disorders
Insomnia
Eating disorders
Emotional and mood disturbances
Fluctuating mood symptoms
Impulsive behaviour
Restlessness
Mental disorders
Tearfulness
Apathy
Orgasmic disorders and disturbances
Panic attacks
Nightmares and abnormal dreams
Hallucinations
Personality disorders
Acute psychosis
Psychotic behaviour
Psychotic disorders
Schizophrenia
Libido decrease
Libido increase
Loss of libido
Sleep disorders
Dysphemia
Bruxism
Alcohol abuse
Akathisia
Completed suicide
Intentional self-injury
Suicidal ideation
Thinking abnormal
Tics
Renal & urinary disorders
Reproductive & breast disorders
Respiratory disorders
Skin disorders
Homicide completion
Vascular disorders
Following on from a series of posts on this blog regarding GSK motions being denied by the Judge in charge of the Dolin v GSK case (Case: 1:12-cv-06403), comes news hot off the press that GSK have, once again, been denied further motions to get this and that pulled. Most notably is the evidence of expert witnesses for Dolin. In brief, GSK wanted to try and stop Dr Joseph Glenmullen and Dr David Healy from giving evidence. Their reasoning behind this motion bordered on desperation because GSK know that both Glenmullen and Healy have worked on Paxil litigation before, both have given evidence that has been damning for GSK.
GSK tried to exclude Healy's evidence based upon a General Medical Council (GMC) hearing that acquitted Healy. Not content with this, GSK wanted to hold their own hearing into the GMC matter, a kangaroo court, if you will. The Judge presiding over matters in the Dolin case has denied them this. GSK claimed that Healy has a "bias" against them (Insert tears here)
Other motions filed by GSK...
- To exclude any reference to GSK’s conduct and Paxil labeling prior to 2004 is DENIED.
- To exclude evidence with respect to FDA’s authority or GSK’s interactions with the FDA is DENIED.
- To exclude hearsay statements and opinions of Dr. Joseph Glenmullen is DENIED.
- To exclude evidence that GSK had a duty to directly warn patients of the risk of taking paroxetine is RESERVED.
- To exclude evidence of marketing and promotion is RESERVED.
- To exclude certain evidence is RESERVED.
Motions Granted,,,
- To exclude evidence of pediatric use of Paxil is GRANTED except as to the FDA’s review of the issue of suicide and the FDA’s review of GSK’s submission in 2003.
- To exclude references to other claims, lawsuits, investigations and reports is GRANTED.
- To exclude evidence of Any plea agreement and settlement is GRANTED.
- To exclude any reference to the “Lilly Protocol” is GRANTED.
- To exclude any reference to foreign labeling or warnings for Paxil is GRANTED.
What does this all mean?
For some, legal jargon is a turn off (not for me though, it's quite the opposite)
Let's break this down in laypersons terms...
GSK wanted to bar the testimony of Dolin's expert witnesses - they failed, in other words, the Judge, more or less, told them that despite filing reasons why experts testimony should not be heard - experts testimony shall be heard and there is nothing more that GSK can do about this. Furthermore, GSK wanted to see documents relating to an unrelated inquiry into Dr Healy. The inquiry was carried out by the GMC and exonerated Healy. Not, seemingly, happy with this, GSK wanted to be allowed to carry out their own interrogation of Healy relating to the GMC investigation - they, once again, failed, the Judge, more or less, told them that the GMC inquiry had nothing to do with the Dolin case, ergo, Healy shall be allowed to give his testimony without being badgered by GSK's attorneys regarding the GMC inquiry.
GSK wanted to exclude evidence relating to their interactions with the FDA, this would include emails, minutes etc. - They failed. The Judge has, more or less, told GSK that they will now have to show why they failed to sit down and discuss Paxil's propensity to induce akathisia and suicide with the American drugs regulator.
GSK wanted to exclude any evidence submitted by Dolin in relation to their conduct and Paxil labeling prior to 2004 - The evidence and conduct of GSK prior to 2004 is something they don't want the jury to see, nor, indeed, the public. In 2004 a black box warning was introduced regarding Paxil's propensity to induce suicide, they (GSK) feel that anything prior to that, ie; evidence that shows they knew long before 2004 that Paxil could induce suicide should not be submitted - they failed, in other words, the Judge, more or less, told them that evidence of them hiding the data and not warning the public about that danger shall be heard by the jury.
GSK wanted to exclude hearsay statements of Dolin's expert, Dr Joseph Glenmullen - Meaning that he would not have been able to offer an opinion based upon documents and clinical trials of Paxil - in a nutshell, GSK wished to gag him. - They failed. The Judge, more or less, told them that Glenmullen is a relevant expert in the field of Paxil inducing akathisia and suicide so they (GSK) cannot suppress his opinions.
Reserved Judgments
A reserved judgment is basically a decision that has not been made by the Judge, in other words, he may need more time and may, at a later date, deliver his judgement.
GSK asked the judge to exclude evidence that they had a duty to warn patients about the risks of taking Paxil. In essence, they don't want Dolin to show the jury that GSK had a moral and ethical duty to provide information regarding Paxil inducing akathisia and suicide. To use an analogy, it's akin to a chef preparing a meal with contaminated food. The chef knew he was using contaminated food but failed to warn the diners in the restaurant. The chef later argues that he had no duty to warn the diners. This motion has been RESERVED by the Judge.
GSK wanted to exclude evidence of the marketing and promotion of Paxil. This includes internal documents and (probably) pharmaceutical rep notes showing how they played down the risk of Paxil inducing suicide. Marketing could be anything from running an advert on television to bribing doctors to prescribe more Paxil, something that they have already been found guilty of in the US. This motion has been RESERVED by the Judge.
Granted Judgments
GSK have been granted a total of five judgments, all of which are common knowledge to the layperson. You'd have to be from the planet Zog to not know about the Paxil pediatric evidence they manipulated (Paxil 329)
They were also granted their motion to not have references to other claims, lawsuits, investigations and reports aired in the Dolin case. Again, Planet Zog inhabitants would be oblivious to GSK's dark history of Paxil causing severe withdrawal (Over 3,000 cases 'resolved' in the US) - Paxil being found responsible for a homicide and suicide - a jury arriving at this decision (See Tobin Vs SmithKline Beecham - Fig 1) - Paxil causing birth defects (Over 800 cases 'resolved' in the US)
Fig 1
Also granted was the exclusion of evidence showing plea agreements GSK have made in the past, this would, more than likely include the above mentioned cases and, of course, the recent plea of guilty and subsequent fine of over $3 billion. Planet Zog inhabitants are probably the only species not to be aware of this. More of GSK's nefarious activities can be seen in video form here, here and here.
More recently, we can see how they handled the widespread bribery and corruption in China, and how, it's alleged, their CEO, Sir Andrew Witty, lied to the media regarding his knowledge of the violations - here and here.
GSK were also granted motions to exclude any reference to the 'Lilly protocol' and also to exclude any reference to foreign labeling or warnings for Paxil.
**Updated**
The "Lilly Protocol" involved using suicidal people in Prozac clinical trials to make it so there were a lot of placebo suicidal behavior events to offset and “hide” the elevated on drug events in meta-analyses of suicidal behavior. Wheadon, the Lilly employee that came up with this idea, transferred to GSK and implemented the same idea which became Paxil MD-057 and 106 which for years were used to undermine the suicidal behavior rates.
As for the exclusion of evidence pertaining to foreign labeling or warnings for Paxil, GSK probably don't want the jury to see how the labeling differs from country to country, or, at the very least, how it used to differ.
Since the claim was filed in 2012 GSK have sent Wendy Dolin more than 30 subpoenas, they have also made over 70 record requests and have shown the Dolin children their father’s private medical notes. To top it all, GSK’s lawyers have been asking (goading) Wendy about her love life since her husband killed himself.
In 2010, Stewart Dolin (pictured) killed himself by leaping in front of a Chicago Transit Authority train at the Blue Line station at Washington and Dearborn streets in the Loop. Dolin was just 57.
He had started taking a generic version of Paxil six days before he leaped to his death.
Following on from the first parter, Lawsuit Alleges GSK's Witty Lied to the Media - Part I, today sees part 2 (The claims of ChinaWhys against GSK) - Part 3 (Coming later this week) will focus on the incarceration of Peter Humphrey and his wife, Yu Yinzeng and also the rehiring of accused whistleblower, Vivian Shi)
Here is what Peter Humphrey and his wife, Yu Yinzeng, of ChinaWhys, are alleging...
- Between 2010-2013 GSK spent nearly $225 million on planning and travel services. Approx 44% of the sampled invoices were inflated and approximately 12% were for events that did not occur. - GSK set up a special "crisis management" team in order to bribe Chinese regulators with money and gifts. A GSK executive attempted to bribe a Chinese investigator with an IPad and a lavish dinner. All bribes were approved by the head of Chinese operations, Mark Reilly. - GSK planned to suppress evidence of its illegal bribery activities. - As far back as 2008, GSK China deliberately falsified its books and records in order to conceal its illegal practices in China. These included, bribery and promotion of drugs for purposes that have not been approved by the Chinese authorities. - GSK paid a patient RMB 50,000, who nearly died after being given Lamictal off-label. Despite having knowledge of Lamictal causing near death in this patient, GSK still told its reps to promote the use of Lamictal for off-label purposes. - GSK targeted 'persuasive doctors' in attempts to influence purchasing decisions at their hospitals. GSK are to said to have forged a connection with these doctors by taking them to expensive lunches and dinners and also giving them gifts and cash. - GSK paid between 500 and 1,000 doctors to go on an all-expenses paid holiday to locations such as Brazil, India, Israel, Greece, Japan and Hungary. GSK covered all costs, including cash to cover meals and sight-seeing excursions. These were disguised by GSK as "Conference trips." - Head of Chinese operations, Mark Reilly, received a bribe in the form of 'sexual relations' in return for passing business on to China Comfort Travel, a travel agency who organised 'conference sevices' for GSK. - GSK paid doctors based on their prescription numbers. - GSK's senior legal counsel, Jennifer Huang, asked private investigator, Peter Humphrey, to investigate the Public Security Bureau and to prepare an analysis of the Chinese political regime. Huang told Humphrey that she wanted to find out who's who regarding the team who were investigating GSK. - Humphrey became concerned that GSK were trying to obstruct the investigation and declined to investigate state secrets. - Humphrey was also asked, by GSK, to look into the Ministry of Public Security, the Economic Crimes Investigation Department regarding the relationship between them and the Public Security Bureau. Humphrey, once again, declined. - Head of Chinese operations, Mark Reilly, told Humphrey that the alleged whistleblower, Vivian Shi was "coming after him." (Humphrey). Reilly then fled China the following day. - GSK China told its employees to "destroy all non-compliant promotional materials and gifts." They also implemented a new email system and deleted emails that were more than a year old. They claimed this was to "reduce unnecessarily legal costs."
Lawsuit Alleges GSK's Witty Lied to the Media - Part I
~ Bob Fiddaman
A 42 page complaint was filed on November 15, 2016, by Peter Humphrey and his wife, Yu Yingzeng, in relation to GSK's nefarious activities in China which saw the pair incarcerated for around 2 years in Chinese slum-like conditions prison cells.
The complaint delves deep into the whole sordid affair and alleges bribery on a huge scale, more importantly, the complaint alleges that GSK hired the services of Humphrey and Yu in efforts to smokescreen the corruption in China, corruption, according to the complaint, that they had known about for many years. Furthermore, the 42 page document alleges that GSK's CEO, Andrew Witty, lied to the media when he was asked about the corruption in China.
Humphrey and Yingzeng were the founders of ChinaWhys, a professional-services consultancy that specializes in discreet risk mitigation solutions, consulting and investigation services to corporate clients in matters of high sensitivity across Greater China and the Asia Pacific.
On April 15, 2013, Humphrey met with GSK's Head of Chinese operations, Mark Reilly, April Zhao, GSK China legal counsel and Brian Cahill, also GSK legal counsel. It was at this meeting that Humphrey was told that GSK had been sent a series of emails from a whistleblower alleging widespread corruption - GSK told Humphrey that they believed they knew who the whistleblower was.
Vivian Shi had previously worked for GSK as a government affairs director, GSK had terminated her services with them in December 2012. According to the complaint GSK claimed that Shi had orchestrated a "smear campaign" against GSK involving a total of 23 emails that had been sent to Chinese officials throughout the country, a letter had also been sent to GSK's 'top management' alleging widespread corruption in GSK's pharmaceutical and vaccine business that had been approved by GSK China's senior management.
These were allegations brought to Humphreys attention just months after GSK had been fined a record breaking $3 billion by the Department of Justice in America - the fine was handed down after a guilty plea by GSK who, after the settlement, entered into a five-year Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services. The agreement requires enhanced accountability, increased transparency and wide- ranging monitoring activities conducted by both internal and independent external reviewers.
One month after meeting with GSK officials Humphrey was told that GSK's global CEO, Andrew Witty, had been made aware that GSK had been using a travel agent to channel kickback to customers and doctors throughout China. Days after Witty had been made aware, the whistleblower also sent a video to him and other senior management that showed GSK China's Mark Reilly engaged in sexual activity - Reilly later claimed that the woman in the video was his "regular girlfriend".
GSK officials told Humphrey that they had launched their own internal inquiry regarding the whistleblower allegation and that they were false. They told Humphrey, "There is nothing there". This, according to the complaint, was a lie.
Humphrey and his wife offered to investigate the whistleblower allegations but GSK declined the offer, opting instead for Humphrey to investigate Vivian Shi, the woman they believed was the whistleblower.
Two months after Humphrey and Yu started their background search of Vivian Shi, GSK received another letter from the whistleblower alleging that GSK China continues to engage in systematic bribery of doctors, this email focused on GSK China's botox business whereby the whistleblower claimed that...
GSK had a 'pay to prescribe' scheme that funneled money through a central source at Beijing Medical College whereby 'lecture fee payments' were made to doctors who could "...incentivize and reward doctors for prescribing Botox."
At no point did GSK show either Humphrey or Yu this letter.
On June 12, 2013, the Wall Street Journal (WSJ) ran an article highlighting GSK China's massive bribery network. In July of that year 4 senior GSK China executives were arrested and, according to Humphrey's filed complaint, GSK CEO, Andrew Witty told the worlds media that "...it appears that certain senior executives in the Chinese business have acted outside of our processes and our controls to both defraud the company and Chinese healthcare system." Witty also claimed that GSK's Head office in London lacked knowledge of the whistleblower allegations and "had no sense of this issue."
According to the complaint, this made no sense as since the previous month GSK did, indeed, "have a sense" of the issue since it announced its 4 month internal investigation into allegations of bribery and corruption in China and found "No evidence of corruption or bribery."
The complaint states...
Witty argued, nonsensically, that the previous whistleblower allegations were "quite different" from the more recent charges, saying, "they are two completely different sets of issues, we fully investigated the first and, of course, this has now surfaced in the last couple of weeks."
This was a lie, since "what surfaced" in the PSB investigation and raids of GSK offices in July was precisely the illegal activity that the whistleblower had documented and threatened to reveal in January.
The complaint was filed in The United States District Court for the Eastern District of Pennsylvania.
Humphrey and Yu are represented by Boies, Schiller & Flexner LLP
**Coming in Part 2**
- A full and comprehensive list of the allegations made by Peter Humphrey and Yu.
- GSK ask Humphrey to 'overtly' obstruct the Chinese government investigation.
- Evidence, including emails, to be destroyed as not to implicate any wrong-doing by the company. Bob Fiddaman Back stories. Glaxo - The Sex Tape Scandal
Although this blog is, in the main, about the dangers of SSRI type medications I have, over the years, also read many horrific stories about those who, through no fault of their own, have become dependent to benzodiazipines. Barry Haslam (below) is one such victim. His account regarding his time on Ativan is strikingly similar to other guest posts on this blog.
Barry, now a sprightly 73, has been campaigning for many years and during my own 10-year research into this murky world of pharma and limp-wristed regulators his name has always popped up from time to time, hardly surprising as he has been banging the drum loudly for many years.
Described by some as 'a pain in the ass', Barry gets things done and with the support of his wife, Sue, whom he has been married to for 45 years, he is a force to be reckoned with.
Be sure to watch the video at the foot of his guest post.
Barry is a fine example of someone standing up to be counted - at 73 he shouldn't have to be doing this, he chose to because he wants to, he chooses to help others because he knows the hell of benzo withdrawal. He chooses to because he is a humanist.
As employees of the British drug regulator sit and drink their lattes they should take a long, hard look at the work that Barry has done, work that they get paid to do yet are failing miserably to deliver.
Take a bow young sir.
Bob Fiddaman.
My Story by Barry Haslam
My story starts in 1976. I had a nervous breakdown whilst studying for my Accountancy Technician examination ( which I passed with distinction ). Plus I was holding down 2 jobs and bringing up a young family. My daughters where then aged 5 and 7 .
I was then prescribed a series of benzodiazepine /antidepressant drugs for 5 years. This information was gleaned from my medical records at a later date (from 1976 until 1986) I have complete memory loss, no memory at all. Then in 1981 I was prescribed 10 mgs daily of the drug Ativan, until in 1985 I was being doctor prescribed 30 mgs of Ativan daily. This amount of Ativan is equal to 300 mgs of Diazepam daily or 15 mgs of Klonopin daily. In addition by this time my headaches where so severe, because of the Ativan, that my doctors where prescribing me 12 opiate painkillers daily.
"My drug induced coma destroyed 10 years of my memory bank permanently."
As a direct result of this horrendously prescribed drug polypharmacy I had become extremely violent towards my wife Sue, who I love dearly. I never actually hit her but came close to doing so. After another violent episode, I actually realised in a moment of lucidity that it must be the drugs causing my perverse behaviour. I am actually a very quiet person but the drug Ativan turned me into a Monster. So on the 19th of March 1986 I withdrew myself from all prescribed drugs, with no help at all from my doctors, who where clueless or frightened of their medical negligence towards me. The factual contents of this story were taken from my medical records years later when I moved to another doctor and my wife, Sue, also verified the drug regime I was on at the time. My drug induced coma destroyed 10 years of my memory bank permanently.
By this time I had lost half my body weight and was down to 7 stone, my rib cage could be clearly seen. The withdrawals where horrendous over my 15-month self-withdrawal period. Vomiting daily, hallucinations, sweats, creatures crawling under my skin and scalp, severe headaches, stomach and urinary problems, intense neuropathic pain all down my right leg, horrendous nightmares where I was frightened of going to sleep, manic anger, joint pains and many other symptoms. I withdrew at home during this entire period.
Due to benzos being stored in the blood, fat tissue and the bone marrow, my immune system was badly affected. I have permanent brain damage (proved by 2 MRI brain scans which show atrophy ie shrinkage.) I also suffer with hypothyroidism, daily chronic migraines, memory and concentration problems and spinal arthritis. Despite these iatrogenic drug-induced injuries I love life and its challenges. My lovely wife, Sue, has supported me throughout. We have now been married for 45 years and have 3 lovely grandchildren. I can now watch them grow up, an experience denied to me with my own 2 daughters which I regret dearly.
I have now been campaigning at local, national and international level on this public health scandal and government cover up for the last 28 years. The following questions need to be asked to those responsible, certainly in the UK where government departments and ministers have thrown this issue in the long grass, terrified of taking the lid off this Pandora Box, prescribed drug epidemic, where no one has ever been held responsible or made accountable for this national scandal.
Why have the doctors and psychiatrists ignored the 1988 Committee on Safety of Medicines Guidelines on the prescribing of benzodiazepines? Ie. prescribe for 2 to 4 weeks only?
Why are the same physicians making the same mistakes with the newer Z drugs which are a benzo by another name? These drugs act on the same brain receptors and transmitters.
Why are alternative therapies such as CBT not more available for patients rather than being given addictive, mind-altering chemicals? Benzodiazepines are a derivative of ammonia.
"For decades the British Government have perpetuated iatrogenic drug addiction by sweeping the issue under the carpet and walking away from accountability to its citizens."
Why have we over 1 million dependent on benzodiazepine, which has been deliberately allowed to grow by the medical profession and weak and ineffective government? Warning signs were there in the 1970s and 80s. The Committee on Review of Medicines in 1980 stated that the efficacy of benzodiazepines was 4 months only for use as anxiety and 7 to 21 days for use as a hypnotic. So what went wrong? The above CRM fudged the issues by stating that that from 1960 to 1977 only 28 persons had become dependent on benzodiazepine drugs. Complete utter rubbish and a massive cover-up by all concerned as during that period 350 million scripts were issued to patients. A SCANDAL OF GIGANTIC PROPORTIONS. Swept under the carpet by those very health officials whose responsibilities should have been to innocent patients and not the Profit and Loss Account of the Pharmaceutical Industry and its shareholders. For decades the British Government has perpetuated iatrogenic drug dependency by sweeping the issue under the carpet and walking away from accountability to its citizens. Cowards the lot of them.
"All our work at Tranx is done by volunteers, ex-benzo patients and carers with no remuneration, just the love of helping people recover their way through drug dependency and return back to themselves and their families."
In 2004 I managed to ‘persuade’ Oldham Primary Care Trust to fund a Benzodiazepine Withdrawal Service for persons living in the town. We estimated that at the time we had 5,200 such long-term prescribed benzodiazepine drug dependents in our area. The contract to provide such services was won by a Charity called Addiction Dependency Solutions which has over 30 branches in the North West of England. It is the only National Health fully funded service in the country and it is still ongoing and successfully withdrawing patients from benzos, z drugs and painkillers. Plus ADS also link up with Oldham Tranx of which I am the Chairman. Tranx has now been giving peer support to the prescribed drug dependents and surrounding districts for 25 years now. All our work at Tranx is done by volunteers, ex-patients and carers with no remuneration, just the love of helping people recover their way through drug dependency and return back to themselves and their families. We put our ‘acquired’ knowledge to good use. Plus we also refer to Professor C.Heather Ashtons of Newcastle University Benzodiazepine Withdrawal Protocol and I count Heather as a good friend and colleague. She is a remarkable lady.
It is this combination of an NHS fully funded facility allied to a voluntary support group such as Tranx that I feel is the way forward in order to tackle this man-made epidemic.
I invited the Minister for Public Health in England to Oldham a couple of years ago to see for herself the progress that we are making. At the meeting, she turned to speak with the Director of Public Health in Oldham and asked “ How did you get involved in all this? “ Smiling he pointed his finger at me and said, “ It was because of Barry, he was a pain in the backside with us, so we had to actively look for a solution to Oldham’s prescribed drug problems.”
So by being a pain in the butt to health officials I have managed to obtain such services to help those who are in desperate need. I am only a little guy and no braver than the next person but I do know right from wrong. This prescribed global prescribed drug epidemic is so wrong. Can I please say to my US friends and fellow benzo patients and ex-patients, never give up hope because YOU can make a difference as an individual and as a group. We keep fighting for recognition, justice, and dedicated services.
God Bless You,
Barry Haslam
Chair, Oldham Tranx. England.
Oldham Tranx
The Link Centre for Independent Living,
140 Union Street, Oldham OL1 1DZ
on Mondays from 11:00am - 1:00pm Contact Barry
A truly fascinating read regarding the corruption in China, all committed by the hand of British based pharmaceutical giant, GlaxoSmithKline.
The New York Times (NYT) recently ran a superb article regarding GSK's nefarious activities in China, activities that saw them plead guilty, a result of which saw them being handed down a $500 million dollar fine.
The article by David Barboza, although brilliant, is tantalizing, in as much that The Times claims to have in its possession emails and documents, none of which they have provided, at least in their entirety.
The China scandal is a story of greed, corruption, cover-ups, bribery and pay-offs, all combined with a sex scandal video and a company burying it's head in the sand over its China practices - preferring instead to go after the person who blew the whistle on the whole sordid affair.
It's a subject I covered many times on this blog (Links at the foot of this post) and one that seems to be rehashed with additions on a regular basis.
The Times article throws out some very interesting facts about the case that were previously kept under wraps - one such fact being that they (The Times) have evidence that "Glaxo “almost killed one patient by illegally marketing its drug Lamictal,” said the email, which was obtained by The Times. “GSK China bought the patient’s silence for $9,000.”"
Glaxo buying a patient's silence? Surely not?
There was me thinking they only did that in litigation, Paxil withdrawal (Over 3,000 patients 'paid off') - Paxil Birth defects (Over 800 patients 'paid off')
So, who was the patient in receipt of Glaxo's $9,000, moreover, what did this patient have that GSK didn't want others to see?
According to the NYT...
The email was one of nearly two dozen that the whistle-blower sent over the course of 17 months to Chinese regulators, Glaxo executives and the company’s auditor, PricewaterhouseCoopers.
In 2012 Glaxo plead guilty to a whole host of violations throughout America, the guilty plea resulted in a record breaking fine of $3 billion. At the time, Glaxo Chief, Andrew Witty, pledged, “We’re determined this is never going to happen again.”
Witty, who had been made aware of the unfolding stench in China shortly after the 2012 guilty plea in the US, is stepping down from his CEO position in April next year - It's quite a legacy he has left behind, one which he took over from former Chief, JP Garnier who, in essence, oversaw the corruption in America and left Witty to suck up the fallout.
What an abhorrent company this is. Corruption, bribery (of officials and patients) and the manufacturer of prescription meds that have either killed people or disfigured them in such a way that they need to continue having surgery for the rest of their lives. Let's not forget those that have suffered as a result of becoming addicted to GSK's medications either.
The Times article also digs deeper into the involvement of Mark Reilly, who, at the time, was Head of GSK's China operations. They claim...
An email alleged that Mr. Reilly, a British national who had helped manage the company’s China operation for four years, was complicit in a bribery scheme tied to a travel agency called China Comfort Travel, or C.C.T. According to the email, Glaxo funneled money through the travel agency to pay off doctors. The travel agency also supplied Mr. Reilly with women, as a way to secure that business.
“In order to acquire more business, C.C.T. bribed Mark Reilly, the general manager of GSK (China) with sex,” the email said. “Mark Reilly accepted this bribery and made C.C.T. get the maximized benefits in return.”
That's some perk to have! China Comfort Travel bring a whole new meaning to the word 'comfort'.
Any jobs going whereby the employer offers a bonus of playing hide the salami?
I'm sure red-blooded males would have been first in-line for such a job working for a company complicit in fraudulent activities. Sadly, for those red-blooded males at least, Reilly was offered (and took) the perk - I wonder if he claimed for the 15 minutes of overtime too? (Assuming that Reilly could last that long in the sack)
When faced with over 17 months of emails from the whistleblower Glaxo decided to seek help, they did so by hiring a private investigator, Peter Humphrey and his wife, Yu Yingzeng.
Humphrey did some digging and, at the time, provided information to Glaxo that pointed to the possible whistleblower. Vivian Shi, was a 47-year-old executive handling government affairs in Glaxo’s Shanghai office, I say former because she was previously fired by GSK for their belief (Before Humphrey was hired) that she was behind the whistleblowing allegations. The 'official' line of her dismissal was that she had been falsifying travel expenses.
Humphrey, it appears, was merely suggesting that Shi may have been involved - he, at no time, ever provided GSK with any evidence that their former executive was the one who was whistleblowing. Shi, who remember had already left GSK, denied any part in the whole Chinagate scandal.
During his investigations Humphrey obtained information that was deemed to be by false means according to Chinese officials. Both he and his wife were later arrested, charged then sent to prison. Meantime, Reilly, who was the mastermind of the whole scam, was sent back home to the UK - No jail time. It's unknown what Reilly is doing today, presumably he doesn't work for GSK in any capacity, although I wouldn't put it past them to re-hire him, just as they did with Vivian Shi, the very person they had fired because they thought she was the one blowing the whistle on its Chinese operations.
GSK must be a truly great company to work for, not only do they offer, by proxy, free blowjobs to heads of operations but they re-hire you after previously sacking you for, ahem, "falsifying travel expenses."
The Timesarticle is a must read and once again highlights how GSK prefer to target people who bring the company's misdemeanors to their attention rather than target the person carrying out the misdemeanors.
GSK Corporate motto claims, "We are dedicated to improving the quality of human life by enabling people to do more, feel better, live longer." - I just never knew this included blowjobs via complicit bribery deals - the re-hiring after breaking rules - and buying patients silence.
One thing you won't see on SSRI patient information leaflets is how to combat the withdrawal effects. There are literally dozens and dozens of Facebook groups offering support to those struggling the debilitating withdrawal effects of SSRIs such as Prozac, Paxil, Zoloft etc. These groups are patients who have either gone through or are going through SSRI withdrawal - they shouldn't be dismissed, in fact, they are far better than what health care professionals have to offer.
The drug companies or medicine regulators won't help, to do so would be an admittance that SSRIs can, for many, cause serious problems when withdrawing and if they admit there's a problem then this will be a sign that they have licensed a drug, or drugs, to the public that can make matters worse rather than rectify or subdue the problem they were originally prescribed for.
When one takes a look at the patient information leaflet one sees the phrase that the benefits of taking an antidepressant outweigh the risks - the risks being thoughts of self-harm, suicide and akathisia, which, in essence, is a pre-cursor to completion of suicide.
Health committees spring up every now and again, their sole purpose, it appears, is to recognise there is a problem withdrawing from SSRIs and, well, and nothing. They offer no advice, they don't tell us why - they merely give you hope by stopping the carousel, asking you for your story then, putting you back on the carousel, ergo leaving you to deal with your problems by yourself - they will of course throw out the one line that covers their arse, "Talk to your doctor."
Most people that have wrote me over the years have told me that their doctors either up their dose when they experience withdrawal or change/substitute one SSRI for another - these patients then leave armed with a prescription and a ticket to ride the carousel.
For years the line 'Talk to your doctor' has been used as a tool by the pharmaceutical industry. To promote the use of SSRIs adverts have appeared on TV, in magazines, by proxy on radio shows where the host has been paid vast amounts of money to persuade listeners to use a certain brand of drug. When the problem of withdrawal kicks in, pharmaceutical companies and medicine regulators continue to use the 'Talk to you doctor' line, knowing that any prescribing doctor does not have a clue how to help people suffering severe withdrawal - Okay, there are some who know how to help, eg; Healy et al, but these are few and far between - perfect for the industry and regulators because it means they continue passing the buck, at the same time avoiding potential lawsuits for defective products.
Speaking of lawsuits, in 2002 GlaxoSmithKline settled with over 3,000 plaintiffs who had claimed that Paxil caused serious withdrawal problems of many kinds, resulting in patients unable to stop taking the drug. The settlement (with each plaintiff) saw them sign a confidentiality agreement whereby they could not discuss the award (monetary) they received from Glaxo. Here's how it works...
Any lawsuit claiming severe withdrawal effects from an SSRI will be denied and defended in a number of stages.
A - We warned them (the patient) already.
B - It was the condition whereby the patient declined into a spiral of decline, ergo this caused depression and the patient suffered anxiety as a result of his underlying illness and coming off the drug that was treating his underlying illness.. (In other words it wasn't a withdrawal effect, it was agitation caused by him stopping the drug. We utterly refute this claim as our drug has benefited millions of people world wide...yadda yadda.
Prosecution team will point out that even by the drug company's own admission their drug can induce severe withdrawal effects and this is where the pharmaceutical company will argue point C.
C - Yes your honour, but we don't believe that to be the case in this particular litigation, we believe it to be the underlying illness that caused what plaintiff deems as 'withdrawal effects'.
When they feel the case slipping out of their hands they offer a settlement, one which they don't have to admit any wrong-doing.
It's a game and pharmaceutical companies play it to their advantage.
Brain zaps
One problem that exists with SSRI withdrawal is the "brain zaps" - if you've never experienced these you are one of the lucky ones - the only way to combat these (to make them go away) is to stop withdrawing and start taking your medication again at the prescribed dose (back on the carousel you go)
Looking through the Facebook support groups it seems the brain zaps is one of the more common side effects - it's played down by pharmaceutical companies and regulators.
In laypersons terms, or to use an analogy, brain zaps is basically your brain trying to deal with something it has become accustomed to over the months, years you having been taking the drug - it's no different to any other reduction you may encounter apart from the fact it gives you this feeling like your brain is being poked by a cattle prod, resulting in your whole body jerking, twitching. Turning your head too quick gives the effect of dizziness - this 'dizziness' is, once again, played down by the pharmaceutical industry and regulators. When reading the patient information leaflet you will see 'dizziness' as a common side effect - it looks harmless - hey, what's a bit of dizziness? For some the dizziness is best described as feeling like a cartoon character, you know they type, the kind of characters whose eyes are able to be pulled out before being let go and retracting at high speed back into their sockets.
More often than not withdrawal will cause this problem. You may turn your head and feel that your eyes do not follow your turn, they are left temporarily stationary in their original position. Once your head is turned it will take them a split second longer to follow the movement of your head - this will cause you the 'dizziness' referred to in the patient information leaflets - this is what taking, or withdrawing from an SSRI, can be like for a lot of people. The vast majority of which find it difficult to describe this 'dizziness' to their doctors.
The brain zaps (your brain wanting it's normal daily fix) is your brain reminding you to feed it. For months or years you have been feeding it a regular dose - so, if you lived on three potatoes, chicken and vegetables for a year, and that meal satisfied you, gave you a sense of being full upon eating it, it then stands to reason if someone came along and removed a piece of chicken or potato, you'd be pretty pissed off - your meal wouldn't satisfy you anymore - you'd be left unfulfilled and you'd probably reach for a snack to fill the gap that the missing potato or chicken piece had left. Same goes for when you are tapering from an SSRI - Your brain has become used to it's regular meal of potatoes, chicken and vegetables.
Now, imagine if just one pea was taken from your daily meal, it wouldn't be so bad, and you probably wouldn't even notice it, right? This is how you have to taper. Personally, I came down by just half a milligram per week. Some weeks, when I wasn't ready to drop another half, I didn't. My body, my rules.
The God Factor
Throw a stethoscope around a neck, give that stethoscope-wearing person a title, such as 'Dr', and you have before you a person that can fix any ailment you may have. These people have been through years of training, they are clever, so much more intelligent than you and I, right?
Wrong.
They have been trained to basically spot symptoms then use a medicine to treat that symptom - that is all - they don't have a magic wand, they do not have healing hands - they are not your modern day Jesus Christ nor indeed should they be treated as such. They are just normal people who chose a career path because they felt the need to want to help people - it's admirable that any human would want to care for another human - Sadly, the pharmaceutical industry is a machine that is constantly striving to see a niche in the market - to take control of that niche they first need to target the agents who sell their wares - namely; your prescribing physician. They, through various methods, convince the young Dr going through med school that they are the good guys, that depression is a disease that can be stabilized and controlled. Somewhere along the line financial and marital problems have become a disease as have fears that have been with us since the year dot. Shyness, being anxious because you have to give a speech are just two examples - both treatable with an array of meds, or so we are told.
If you've read this far down then you are probably here because of the title of this post, "SSRI Tips and Tricks on Withdrawal."
It's important to know why you are here and reading all of the above will, hopefully, give you the reason. You are not crazy, you are not in the minority, you are not abnormal - the drug you were prescribed was licensed by a regulator based upon the benefits you may receive from it. To date, the British drug regulator, cannot list one single benefit for any of the SSRIs on the market. They claim that these invisible benefits outweigh the highly visible risks - You've been duped ladies and gentlemen, just like your prescribing physician. (Source -Correspondence between myself and the MHRA)
So, the zaps - horrible aren't they? Kind of make you curl up into the fetal position because that's the only way you can cope, right?
There is a way that may or may not help you. It's free, it doesn't involve putting anything into your body apart from tap water (or bottled water if you prefer) - in fact, water is used a lot in these series of tips.
You won't see these on the patient information leaflet because, well, because the whole idea of selling sickness is to not warn you about the severe side effects you may experience.
1. If you decide to taper do so in the winter months and not the summer months. I can't quite put my finger on why you should choose the colder months but I know, through my own tapering experience of Paxil withdrawal, that it seemed to be worse when it was warmer outside.
2. Never try to quit by going cold turkey. Don't attempt to taper by missing doses every other day. Don't attempt to taper by halving your pill, although for some (Cymbalta for example) there is no liquid formulation, which brings me on to tip number three.
3. Taper using the liquid formulation (if you can) - Don't ask your Dr for the liquid, tell him/her - Dr's are there to help you and, at the end of the day it is you that is suffering the withdrawal, it is your brain crying out for its extra potato each time you skip or halve a dose. Tell your Dr you wantto be prescribed the liquid - Do not ask.
4. Go at your own pace when withdrawing, this is not a sprint, it's a marathon and may take many months or even years to get completely off the drug. Again, many Dr's will dispute this, if they do then give them the middle finger - remember, this is your plate you are eating from and not theirs.
5. The dreaded brain zaps - Okay, this is my own personal tip, it helped me somewhat.
Run a bath full of cold water. Find a suitably sized bath towel and soak the towel in the water. Wring the towel and wrap it around your head in the style of a turban. Keep repeating this process once the towel starts to dry or if the zaps appear again.
6. Run cold water over your wrists (the part where you feel your pulse)
7. Go for walks (again the winter months is probably best) - Don't overdress - wear loose clothing - this may be difficult as you have probably gained a lot of weight during your time on your SSRI. Walk and push yourself - don't just walk around the block, find a park, tell yourself you are going to lap the park just by walking - treat the cold weather as your friend. Treat the walk as a way of helping you and not as a chore - at the same time weight will fall off you - let the daily walk be your addiction.
8. Drink lots of water, up to 8 pints a day - yes, it seems a ridiculous amount but you are basically helping flush out the culprit causing you the problem - If you can't manage 8 pints then just drink as much as you can - in any event, water is good for you.
None of the above will cost you a single penny - give it a try and write to me in a few months time to let me know if you feel you are on the road to recovery after using these tips.
In the meantime, good luck - you willget there - maybe once you do, you can advocate and help others stuck in this rut of SSRI withdrawal, particularly children.
