Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Saturday, August 13, 2011

GSK Respond - "Dr Benbow is no longer with GlaxoSmithKline."



Some of you may know that I have been requesting information from British pharmaceutical giant GlaxoSmithKline regarding comments made by their employee Alastair Benbow on national TV and to BBC investigative journalist Shelley Jofre.

A recent document that surfaced shows an exchange of words between Benbow and Jofre from October 2002. This actual transcript shows Jofre press Benbow for an answer regarding Seroxat withdrawal, much of the transcript never made the final edit.

My request to GSK was thus:


To whom it may concern,

1. In a 2002 interview with BBC TV's Shelley Jofre, GlaxoSmithKline spokesperson, Alastair Benbow, claimed that, "... the majority of patients who experience withdrawal symptoms - and the majority of patients actually do not experience any withdrawal symptoms - of those that do the majority of those symptoms are mild to moderate in nature and will go away without any treatment within two weeks." He was, of course, referring to the antidepressant Seroxat. Under the FOIA I would like GlaxoSmithKline to provide me with the study/studies that substantiate Dr Benbow's claim.

2. Furthermore, in the same interview, Dr Benbow claimed, "maybe that a small proportion of patients do get more severe symptoms...". Under the FOIA I would like GlaxoSmithKline to provide me with the study/studies that substantiate Dr Benbow's claim. The full transcript, which has recently been released, was part of disclosure and used in litigation against GSK in the United States and is attached for your perusal.

Yours sincerely,

Bob Fiddaman


On Thursday August 11, I wrote a scathing article and published it on my blog. An hour or so before I published the article I announced on Twitter, "**Exclusive - GSK's Andrew Witty in Patient Aftercare Snub - Keep your eye on the Seroxat Sufferers blog" [Fig 1]

Fig 1

At 4.47pm, just 13 minutes before I was due to publish my article, GSK replied to my request, a request that I had sent them three times!

When I say replied, it was basically GSK side-stepping what I had asked for.


Here's the reply:


Dear Mr Fiddaman,

Thank you for contacting the Medical Information Department at GlaxoSmithKline regarding our product Seroxat* (paroxetine hydrochloride hemihydrate) and thank you for providing us the transcript of the Panorama interview.

You have requested information on study/studies that substantiate some selected quotes from Dr Alastair Benbow with regard to Seroxat during that interview back in 2002. Dr Benbow is no longer with GlaxoSmithKline and therefore it would be inappropriate to attribute substantiation data to him without any consultation. However, the tenor of what is quoted is supported 9 years later in the current prescribing information for Seroxat, namely that:

· in clinical trials adverse events seen on discontinuation occurred in 30% of patients treated with paroxetine compared to 20% of patients treated with placebo;

and

· generally these symptoms are mild to moderate, however, in some patients they may be severe in intensity;

and

· generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more)

For your information some of the clinical trial data for paroxetine in terms of nature and frequency of withdrawal reactions are available in the public arena and discussed via the information presented on p126 of the CSM EWG report of 2004. Lastly, and as before, information about GSK’s clinical trials is available on the GSK Clinical Trial Register at GSK.com.


You will notice GSK's selective choice of words, such as, “generally” and “most”. What I actually requested were the studies that could back up Benbow's claims. So I wrote back the following:


Dear GSK,

With respect, you have not provided me with the information I requested.

Your employee, Alastair Benbow made the statements on national TV.

I would like to see the evidence that backs his claims.

If I wanted a snapshot of a patient information leaflet I would have downloaded one. You are not being transparent here.

Best

Bob Fiddaman


As yet, GSK have not replied to me.

It is interesting to learn that Alastair Benbow is no longer with GSK, quiet convenient that the one person who has the answers to why he said what he did no longer remains as GlaxoSmithKline's spokesperson.

So, in essence, I have requested studies that back up Benbow's claims - GSK cut and paste information off the Seroxat patient information leaflet and send it to me.

Clearly not good enough! I'll keep you posted should GSK ever send me the evidence that supports Benbow's claims.

Back story: **Exclusive - GSK's Andrew Witty in Patient Aftercare Snub



Fid 

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

AUSTRALIAN ORDERS HERE



Thursday, August 11, 2011

**Exclusive - GSK's Andrew Witty in Patient Aftercare Snub




I'm on a quest around the world to find Bigfoot.

I'd originally set out to see if GlaxoSmithKline would actually help patients affected by Seroxat... but I decided to keep my goals realistic.

Here's why.



A short time ago I highlighted the plight of "Zoe", a Seroxat sufferer who has been screaming for help in getting off her daily dose of Seroxat.

Zoe, you see, wants to try and kick her Seroxat addiction into touch. She's currently down to 2.4mgs and is having to use the sickly oral suspension that comes complete with an oral syringe.

She drops by 0.5mgs per week, anything higher is intolerable. It was myself who recommended to Zoe that 0.5mg would be slightly easier than a whole 1mg.

I've previously suffered the addictive qualities of Seroxat. It took me 18 to19 months to taper from 40mg per day to 22mg per day...in the end I went cold turkey. The 'two weeks' of tapering quoted by Alastair Benbow and Mary Anne Rhyne, both GlaxoSmithKline spokespersons, was poor advice based on...um...well, it's not known what their claims were based on. I have been asking GSK via the Freedom of Information Act but, despite two requests, they have failed to answer me. More about that later.

I gave Zoe the suggestion because neither her psychiatrist or doctor could recommend a tapering regime for her, neither could GlaxoSmithKline. Zoe had contacted them and asked for help... they told her to 'talk to her doctor.' When I say 'they' told her, I actually meant they got one of their highly paid lawyers to speak with her on the phone. Classy huh? Even more astonishing was this lawyer's apparent ability to predict the future. Zoe pressed him about the current UK Seroxat litigation, he replied by telling her there would be a major announcement about that soon. [Still waiting Mr Blabbermouth]

You see, there is no advice that GlaxoSmithKline can offer because they just don't know. The Seroxat clinical trials went on, at a guess, for approximately two years. Any person, today that goes over two years on Seroxat are basically venturing into the land of the unknown.

Another patient who contacted me [who wishes to remain anonymous] also wrote to GSK asking for help. Here's their reply:

Click on image to enlarge

The frustrated patient wrote back an angry response to GSK:

I recently E mailed you concerning my terrible experience while discontinuing , and after Taking your so called wonder drug Seroxat !!

And I must say that I am not impressed with your response !! And that I refuse to sign the consent form to give you access to contact my GP and investigate my medical files !! why you may ask ?? I’ll tell you !! you only wish to investigate for your own benefit !! and have absolutely no intention or interest in helping myself or anyone else in my situation !! You manufacture these products so must have a resolution to put things right when they go wrong as they have !! DO YOU ?

The reply continued with...

Mr Witty and Mr Benbow should be thoroughly Ashamed of themselves for defending this Drug !! I hope you pass on this letter to them so they can read for themselves what SEROXAT has done to Me...

Benbow, not shy in front of TV camera's, accepts there may be patients who take longer to 'discontinue', Glaxo's spin for 'withdrawal'. He does not tell us why though, nor does he tell us how. Why? Because he doesn't know.

A university student also contacted me, he, just like the above two patients, was trying to taper from Seroxat. Things got so bad for this particular patient that even a reduction of 1ml per month on the liquid form of Seroxat was proving to be too difficult.

He was given a reduction plan by his local prescribed medication support service, a service ironically run by the NHS. He told me, "I think part of the problem was making a reduction and then waiting for my brain to adjust. This method seems to attempt to get around that problem, and seems be set out over a realistic time span."



The current advice on the Seroxat patient information leaflet is to taper by 10mg per week. The above tapering plan appears to show that Glaxo's advice is way too ambitious - The above withdrawal plan, for the patient who is stuck on 10mg, is expected to last a staggering 71 weeks!

Don't you find it astonishing that the NHS acknowledge that SSRi withdrawal is severe, or at least this one small centre does, yet the manufacturers of these drugs and those that are supposed to regulate them, don't?

The Pwll Glas Resource Centre is a small centre servicing a small town [Mold] and the Prescribed Medicine Support Service is only a small part of what they do. The centre is mainly where Community Psychiatric Nurses [CPN's] are based and deal predominantly with mental health problems and run Cognitive Behaviour Therapy counselling services. I wonder if they have contacted the manufacturers of these drugs and asked for help in getting their patients off them, I wonder if they were told to refer to the patient information leaflets? It's utterly absurd that we have an acknowledgement from a small centre in a small town which is run by the NHS, yet we have no acknowledgement from our own government, medicine regulators and pharmaceutical industry!

71 weeks is 1.3 years. An astonishing length of time to taper off a drug that Glaxo claim takes just 2 weeks!

I'm neither shocked or surprised at the attitude of GlaxoSmithKline with regard to the above three patients and for the hundreds of thousands who are guided by Glaxo's advice on the patient information leaflets. This isn't the first time they have shirked their responsibilities, it won't be the last.

In 2009 a jury concluded by a majority of 10-2 that Seroxat was the causation in Lyam Kilker being born with heart defects. Internal documents to surface from that trial showed how Glaxo knew as early as 2001 that Seroxat may cause pregnant women to give birth to children with defects. The internal document showed how a woman had wrote to Glaxo in May 2001, she wrote:

**Paxil is the US brand name for Seroxat.
"I was diagnosed with panic disorder about four-and-a-half years ago. Since that time I've been taking Paxil, which is truly a miracle drug. I've been panic-free with this drug and have been able to go on with a normal life.

"I was married in October of 2000. My husband and I found out we were pregnant at Christmas time. I was so excited. I love children. The only problem is that I carried the baby to six months gestation and then had to have a termination.

"The doctors diagnosed my son with Truncus arteriosis. They said he would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered (if he was able to make it to that time).

"To say the least, I was absolutely distraught with this news. I thought this was something that I did [...] because I stayed on the Paxil for selfish reasons.

"I wanted to know if you could direct me to any information you might have of any woman that has taken Paxil and still had healthy babies.

"My husband and I are ready to try again to get pregnant in the next monthor two. I am so nervous. I don't want to stop taking my miracle pill. But, then again, if there is a chance that this might hurt or affect the baby, I want to know upfront. And I will somehow stop taking it for the time being.

"Please contact me as soon as possible. I love everything this drug has done for me. I am so thankful that your company had this available for me. I just want to continue to have a normal life and have the child that I always wanted.

"Please contact me as soon as possible ... Please don't forget about me."

The same woman sent a second email on June 1 2001, this time she wrote:

"This response is in regards to an e-mail that I had sent you previously. I was asking to see if you have any or are in the process of any clinical trials for women who are currently on Paxil and pregnant. I wanted to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have healthy babies.

"I am in no way insinuating your product did this to my child. I love the product, and I don't think I could have gotten through my panic attacks without the wonderful help of this miracle drug.

"I just want to start to try and get pregnant again soon. I do not want to put my unborn child through anything that would hurt him/her.

"Please, if you do not have this information, where is this information held? Does anyone do studies like this? Please, any information you may give me would be great. Thanks again for your help."

Glaxo responded to the distraught woman five days later on June 6 2001:

"Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition.

"Because patient care is individualised, we encourage patients to direct questions about their medical condition and treatment to their physician.

"We believe that because your physician knows your medical history, he or she is best suited to answer your questions.

"Our drug information department is available to answer any questions your physician or pharmacist may have about our products. Your healthcare professional can call our drug information department ..."

Once again, Glaxo were telling a patient to talk to their doctor!

What they didn't tell either this woman or her doctor was the discussions they had after they had received her emails.

An internal document shows them blaming their own drug Paxil [the US brand name for Seroxat]

Case number A0348482B", dated 13 June 2001, states: "Relatedness assessment to medication – almost certain."

Still, Glaxo never told this woman or her doctor! One has to ask the question why?

During testimony presented to a Pennsylvania jury, Glaxo officials indicated in 2001 that they were “almost certain” that Paxil caused a heart defect in an unborn fetus. Former Glaxo drug-safety executive Jane Nieman testified that the determination was made by an unidentified Glaxo employee in the company’s database after the mother emailed the company inquiring if there was a connection between her use of Paxil and the birth defect.

In fact, Sean Tracey, the lawyer representing the Kilker family, said in his opening statement of the trial that Glaxo executive, Bonnie Rossello, wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. She wrote, “If neg results. can bury.” This statement by Rossello was to do with withdrawal.

Do you see a pattern forming here?

Janice Simmons, who operates the Seroxat User Group, has amassed over 60,000 emails from Seroxat patients, most of them are struggling to get off Seroxat. Janice cannot tell them how to combat the side effects such as; electric zaps, suicidal thoughts, intolerance to sudden loud noises, bouts of crying, headaches and visionary disturbances etc.

So, Janice decided to request a meeting with GlaxoSmithKline's CEO, Andrew Witty. To her surprise, GSK’s UK medical director Dr Pim Kon wrote back asking what she wished to discuss...adding that they cannot give advice to patients, they need to seek that from their healthcare professionals. [Yawn]

Janice informed Dr Kon that she wished to discuss the issue of Seroxat withdrawal. Kon wrote back telling Janice that they was not allowed to discuss personal matters with patients and that they should 'talk to their doctor'. [Another yawn]

Is that  building in Brent surrounded by mountains? The echo is unmistakably obvious. YODEL-AY-EE-OOOO


Kon added that the Seroxat patient information leaflet had been updated with information about [ahem] 'discontinuation' .

Dr Pim Kon is no stranger to controversy. Last year she told the InPharma magazine that European regulators [EMA] were wrong to withdraw its diabetes drug Avandia from the market. Avandia was suspended by the EMA last year because of high levels of heart attack, heart failure and strokes in patients

Let's take a gander at Glaxo's Seroxat withdrawal advice:

Do not stop taking Seroxat until your doctor tells you to.

When stopping Seroxat, your doctor will help you to reduce your dose slowly over a number of weeks or months - this should help reduce the chance of withdrawal effects. One way of doing this is to gradually reduce the dose of Seroxat you take by 10 mg a week.

10 mg per week? Ah, I can see why they have plucked this amount out of thin air. The maximum dosage for mild depression is 20mg, if you drop by 10mg per week Glaxo have their "It takes the majority of patients two weeks to discontinue." I'm reminded of a song by Ian Dury and the Blockheads, "There Ain't Half Been Some Clever Bastards" - (Dury, Jankel - 1979)

INTERLUDE



Janice wrote back to Kon and asked if GSK could provide her with any studies that GSK had carried out on withdrawal from Seroxat to back up GSK's statement that 'it may be helpful to reduce by 10mg per week and withdraw over the course of 2 weeks. - Kon, after a period of two weeks, has failed to provide Janice with any such evidence.

So, it's a given that I am not fond of GlaxoSmithKline, in particular their spokespersons Mary Anne Rhyne and Alastair Benbow. I'm not particularly fond of their highly paid lawyers either, have any of them ever seen the movie The Devil's Advocate? Keep on telling yourselves that you are doing a great job folks. You know, I'd really like to see things from your point of view but I can't seem to get my head that far up your arses!.

Here's the paradox. GSK refuse to help patients who contact them with regard to difficulties weaning off Seroxat. They quote the ABPI Code of Practice and tell the patient to 'talk to their doctor'. The doctor either thinks their patient is still suffering from the original illness or knows that the drug is addictive but still prescribes it anyway! A recent survey showed that almost 80% of doctors routinely prescribe drugs to which they believe the patient may be addicted! GSK's lawyers support them [GSK] to the hilt despite witnessing the devastation this drug has caused. Round and round we all go, caught in the psychopharmaceutical trap folks. It's a merry-go-round that isn't very merry at all. We want to get off but the pharmaceutical industry, doctors, psychiatrists and lawyers won't let us, they just keep on spinning the ride and the truth.

By Glaxo's own admission, Seroxat can cause withdrawal problems for some. Yet they have defended every single accusation that Seroxat has caused problems for their consumers, instead they blame the original illness or other mitigating factors, anything but the very same drug they say 'can' cause withdrawal problems for some people. Glaxo's Seroxat now carries a warning for pregnant mothers, yet every single mother whose child has been born with defects get no admission of liability from Glaxo. Glaxo's wonder pill can also cause suicide, once again they have never once admitted liability for any suicide on Seroxat. They defend this medication yet say all of the above are possible. That's like a chef presenting you with a steak, the steak may kill you or give you botulism but the Chef, although admitting that the steak he cooked could be harmful, will deny any wrongdoing if you pursue the matter, he, in actual fact, will blame everything...but the steak. It's GSK having their cake and eating it.



The Olive Branch snapped in half.

Had Witty been brave enough to meet with Janice Simmons I would have just loved to have been present. I would have liked him to help people come to terms with their Seroxat addiction, I would have liked him to acknowledge that people, like Zoe, need help and I would have liked his company to pay for that help by way of offering her, and people like her, a placement on a detox program.

I would have also have liked Andrew Witty to help those who have been off Seroxat for sometime but have been left with long term side effects. Long term effects that they, once again, deny.

Now, Witty, and indeed all of Glaxo's spokespersons, can continue down the road they've all been stuck on for all these years and deny Seroxat causes a myriad of side effects or they can start helping those that their product has harmed.

Any response along the lines of, "Seroxat is not addictive" or "Seroxat has benefited millions of people worldwide" would have been seen as an attempt of impunity and would have been greeted with a two finger salute, by me at least. It would also have been acknowledged that the only reason GSK roll out these boring statements is to protect themselves from litigation.

On the subject of litigation, I would have liked Andrew Witty to give those that have been harmed by his company's drug some closure. Let them be allowed to turn around to all those finger pointers and say, "I told you it was a side effect and not the 'real' me."

I guess any admittance would have had repercussions on the benefits system here in the UK too. Any acknowledgement that Seroxat can debilitate people during withdrawal and even years after stopping it could see a deluge of disability claims. The government wouldn't want that now, would they? And with Mr Witty appointed as Lead Non-Executive Board Member for the Department for Business, Innovation and Skills in 2010, I can only assume that they would take a dim view if he were to admit his company's product harmed people to the point where they could not function properly. I can only begin to imagine the amount of money Mr Witty is saving the UK government by not announcing that his company's product has caused so much pain and misery to thousands of UK residents. Of course, he will argue that it has helped "millions of people worldwide", which doesn't really address the outstanding issue, does it?

You see Mr Witty, I've got the staying power of an energy saving light bulb. I can, and will continue to highlight articles in the press regarding your company. I'll also continue to offer readers of this blog court documents if and when they become available, documents from the USA where your attorneys have struck deals with claimants, only to be silenced by gagging orders because, it would appear, you want the truth suppressed.

I'm like one of those little bunnies that play the drums in the TV adverts, I can keep on going because I've been loaded with the Duracell batteries and not the normal ones, capice?

Oh, and please don't quote the safety reviews carried out by the 'expert' working committees either. An expert would be able to tell me and the thousands of others how to wean off your product without having to experience the intolerable side effects for days, weeks, months and years on end. The committees are basically the MHRA with a few 'outsiders' thrown in to show there is no conflict of interest...we all know there is though.

Any association with the MHRA is seen, by me at least, as a total embarrassment. Both the expert working group and MHRA are clueless and, it would appear, they have no desire to change. You could, however recommend a decent shampoo for employees of the MHRA, their scalps must be terribly itchy with all that sand their heads have been buried in all these years. Not to mention the kind of 'expert' witnesses Glaxo's lawyers have called upon to defend their product in the current UK Seroxat litgation. Remind me who Rashmi Shah used to work for again please?


  • Dr. Rashmi Shah is the owner of Rashmi Shah Consultancy Ltd, located in Slough, Berkshire, UK.
  • Shah was employed by the MHRA between 1987 and 2004. Positions held were: Senior Medical Officer, Senior Clinical Assessor and Senior Medical Assessor.
  • An employee of the MHRA for 17 years.

The regulator and Pharma, as one. Snug as a bug on a rug.

Let's not forget the head of licensing at the MHRA, Dr Ian Hudson, whom were his previous employers?

SmithKline Beecham!

And his role at SmithKline Beecham?

World Safety Officer!

In fact, one of Hudson's significant involvements was with paroxetine, that's Seroxat for those that don't know. [Source]

Is it any wonder the MHRA give Seroxat a clean bill of health each time it is reviewed?

Their Chairman's embarrassing performance in front of TV camera's trying to defend Seroxat was plain to see for the millions that tuned in BBC's Panorama exposĂ©. And who is their Chairman?

Alasdair Breckenridge.

His former employers?

GlaxoSmithKline [Formerly SmithKline Beecham]

To coin a phrase, "This crap just writes itself."



You want to improve Glaxo's image? Make a stand, be the first pharmaceutical company to hold up their hands and say, "You know what, the customers are right...they do need our help." I guess that would boil down to an admission of guilt though. When was the last time Glaxo ever admitted any wrong-doing...apart from when they were forced to?

An apology would have been nice but I can't say for sure if it would have been accepted by the likes of the Gatchell, Carlin and Keegan families, whom have each lost a precious life because they actually believed it when they were told their teenage children would be okay taking your product.

It takes a big man to step up to the plate, are you that man Mr Witty? Obviously not.

Can you imagine how good it would have felt if you, Mr Witty, were part of the solution?

Alas, it appears you are not up to the challenge. Why am I not surprised! Maybe you are allergic to people? Isn't that how Glaxo first promoted Seroxat in the US with a huge poster campaign? [SOURCE]

Seroxat is rarely prescribed any more in the UK, recent figures show that it is, in fact, the least prescribed SSRi in the UK today - why is that?

Don't bother answering...we all know why, don't we?

I am left wondering how your company came up with the idea to treat depression, anxiety and shyness. Did you ever think about how one could be diagnosed? It amazes me that psychiatrists and doctor's can diagnose a patient without any form of removal of bodily fluids. Nothing was taken from my brain when I was prescribed Seroxat nor did I have to urinate into a jar or have blood taken to show I had the blues.

One would think that a manufacturer of a product would act upon a defective product, particularly if that product was to be used by millions of people. Then again, sadly, the UK public aren't even considered when it comes to your company acknowledging Seroxat withdrawal. Readers of this blog will be surprised to know that GlaxoSmithKline have made over 3,000 out-of-court settlements in America, all those settlements were to do with the withdrawal issue. A settlement means no liability, once again Glaxo can refer those left suffering to their doctors.

Glaxo launched Seroxat in direct competition to Eli Lilly's Prozac. Lilly, being Lilly, saw this as a threat. So battle did commence.

According to this recently surfaced internal file, GlaxoSmithKline [then SmithKline Beecham] knew of two studies that Lilly had carried out, those studies showed that Seroxat showed significantly higher rates of withdrawal problems when compared to Prozac.

How did GSK handle this?

Well, instead of addressing Lilly's findings they decided to play down the issue of Seroxat withdrawal. The fact that Seroxat withdrawal problems were significantly higher than Prozac saw Glaxo's team pull together the following plan.

Click to enlarge
Click to enlarge

You will note the date of the memo is July 1997, that's 14 years ago!

It would appear, Mr Witty, that your company were already debunking the withdrawal problem with spin way back then.

Personally, I believe your company royally ballsed up by not carrying out any extensive studies into the protracted withdrawal of your product, choosing instead to set money aside for future out of court settlements to consumers that had to go through the legal system to get some kind of justice after being harmed by your drug. Money well spent for Glaxo, probably all part of the insurance cover your company takes out when they launch a product. I believe that money would have been better used on a withdrawal study, then again you already knew about the withdrawal problems early on, didn't you...well maybe you didn't but your predecessor, JP Garnier, must have known, right?

Is it any wonder that you have decided not to manufacture or invest any more of your billions into antidepressant medication?

"You don't need a weatherman to know which way the wind blows" - Bob Dylan

I'd also be grateful if you could ask your company's spokespersons to put a lid on making statements every time another child or teenager dies whilst on your product. Statements with the tired out phrases, "we utterly refute" and "Seroxat has benefited millions of people worldwide" really do nothing to ease the pain of the parents, brothers and sisters left behind.

It would be real nice if you could chase up a couple of Freedom of Information requests, they are just basically questions, I understand that, even by using the FOIA, you are not obliged to answer... be worth your while if you did though. I will understand if you don't want to - any answers would kind of leave a door open to further probing of Seroxat, wouldn't it?

GSK Customer Relations - UK


The following request I make under the Freedom of Information Act.



To whom it may concern,

1. In a 2002 interview with BBC TV's Shelley Jofre, GlaxoSmithKline spokesperson, Alastair Benbow, claimed that, "... the majority of patients who experience withdrawal symptoms - and the majority of patients actually do not experience any withdrawal symptoms - of those that do the majority of those symptoms are mild to moderate in nature and will go away without any treatment within two weeks." He was, of course, referring to the antidepressant Seroxat. Under the FOIA I would like GlaxoSmithKline to provide me with the study/studies that substantiate Dr Benbow's claim.

2. Furthermore, in the same interview, Dr Benbow claimed, "maybe that a small proportion of patients do get more severe symptoms...". Under the FOIA I would like GlaxoSmithKline to provide me with the study/studies that substantiate Dr Benbow's claim.

The full transcript, which has recently been released, was part of disclosure and used in litigation against GSK in the United States and is attached for your perusal.

Yours sincerely,

Bob Fiddaman

And this one to GSK Australia:

I've recently learned that GSK Australia rolled out the a plus project in 2002 The project, as I understand, was for the promotion of the antidepressant Aropax.

My questions, submitted to you under the FOIA, are thus:

1. How many patients were enrolled in the a plus project?
2. How many of the patients were under the age of 18?
3. Did the starter packs just contain packets of Aropax with 20mg tablets or were there starter packs with lower doses?
4. What were the qualifications and training of the counsellors on the a plus project?
5. What were the sales trends of Aropax in Australia before, during and after the a plus project?
6.How much did GlaxoSmithKline pay individual key opinion leaders, including (but not limited to) Professor Graham Burrows and Professor Bruce Singh? What were the services for which each was paid?
7. What were the goals of the a plus project?
8. How long did the a plus project run for?
9. How many adverse reactions were reported for Aropax during the project?
10. Were participants on the a plus project ever followed up or did GlaxoSmithKline Australia lose touch with the participants once the project had finished?
11. Why was the project ended?
12. Was the a plus project deemed a success by GlaxoSmithKline?.
13. Has GlaxoSmithKline or its subsidiaries ever offered similar counselling sessions to patients taking other drugs manufactured by the company?
14. How much did GlaxoSmithKline pay for sponsorship of the Depression Awareness Journal around the time of the a plus project?

Mr Bob Fiddaman

Chase these FOI requests for me Mr Witty, there's a good chap.


Finally, could you ask GSK Japan to justify the money they have recently spent on a Seroxat clinical trial aimed at 7-17 year old children.

Oh, don't bother screaming like a big girl to your lawyers. I'm merely asking for things and making a mockery of your company and their stance toward making people do more, feel better and live longer. Ironic that you have never changed that motto despite all those that have been harmed by your drugs.

I'm ashamed that GlaxoSmithKline are a British company. I'm astounded that you continue to refuse to help patients who are suffering at the hands of your product. To me that's an intention to inflict emotional distress, you merely hide behind the Association of the British Pharmaceutical Industry code of practice, a great weapon of mass deflection you have there Mr Witty. Ooh look I just did a play on words, "Weapon of mass deflection." [Scroll up and play Ian Dury again if you feel inclined]


Our current government, in fact any party voted in, see you as the jewel in the crown.

One only has to look at the 2001 Pharmaceutical Industry Competitiveness Task Force Final Report to see how the industry is revered.

Page 20 - 'The UK benefits in the following ways from the pharmaceutical industry...

Returns to UK shareholders, tax revenues accruing to the UK Exchequer and benefits arising from terms of trade.

I can only guess that if they were to ever mess with GSK, you could always move your business elsewhere. That's quite a grip of the gonads Glaxo have on the UK economy.


Looks like I have chosen my unpaid career as someone who will continue to write about you and your company until you put things right. Any threatening letters by your lawyers will be copied and re-published on this blog.

I'd copy in the press with this post but seeing as you have one of the Murdoch's on your board at GSK I can only assume that they will only print what you want them to. Remind me, what exactly is James Murdoch's role at GSK? Did he have any input into your promotion/protection of the MMR Jabs? There are many that are suggesting he did. [Rupert Murdoch, Brian Deer, Dr Andrew Wakefield and fabricated lies]

Tut tut - children the targets yet again!

I guess it will all come out in the wash eh Mr Witty? - Just like your product, Ribena, you know, the one that you said was "Full of Vitamin C", when actually it wasn't! [SOURCE]

It's entirely up to you whether you wish to reply, I doubt you will.



**Inserts Duracell battery and proceeds to bang the drum.









Bob Fiddaman
Former Seroxat addict
Left with long term adverse reactions due to ingesting Seroxat for 6 years

"When stopping Seroxat, your doctor will help you to reduce your dose slowly over a number of weeks or months - this should help reduce the chance of withdrawal effects. One way of doing this is to gradually reduce the dose of Seroxat you take by 10 mg a week." - Seroxat Patient Information Leaflet 2010









Wednesday, August 10, 2011

The Parental Consent Act - The Petition



Dear readers,

I'd be really grateful if you could head on over to a petition that I am fully behind. Although this is an American petition, it's purpose is to send out a crystal clear message to those who feel psychiatric drugs are safe to use in children.

The madness must stop, you can help by signing the petition.

Here's part of the blurb:

This petition is in support of The Parental Consent Act, a federal bill introduced by Congressman Ron Paul, which prohibits federal funds being used to establish or implement any mandatory or universal mental health/psychiatric screening of schoolchildren. It also establishes a parent's right to refuse mental health screening of their child. This is a crucial bill which must be passed to guarantee parental rights. We urge everyone to sign the petition in support of this bill. 

SIGN HERE 

For more information on The Parental Consent Act please visit Ablechild, an organisation co-founded by a good friend, Sheila Matthews.





Fid


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Tuesday, August 09, 2011

UK Civil Unrest - Is It Time For the Army To Step In?

Image: Daily Mail


Three nights of violence, looting and civil unrest in London, surrounding areas and other parts of the UK and the coalition government have called for an emergency meeting. Great, superb - sorry to spoil your holiday Mr Cameron.

Earlier this year the coalition government announced plans to cut the police force by 34,000. Last night, in London, the police called for reinforcements - reports claim they were given an extra 300 or so officers. Whoopy Doo!

What we have here is civil unrest, this has nothing to do with the shooting of Mark Duggan a few days ago. It's opportunistic youths who have seized their chance to take what isn't there's, to act out what they play on games consoles.

The TV pictures show us young children roaming the streets, God only knows where their parents are...or if they even care.

There have been many arrests overnight, most will be charged and bailed only to appear in court at a later date and given a fine [that they can't pay] community service [that they won't do] or a slap on the wrists. Our prisons are full to the brim, the likelihood of sending these yobs to Her Majesty's hotels is pretty slim - the yobs know this.

I understand the youth have grievances with the establishment, I understand that they don't wished to be tarred with the same brush by the police force, I understand they want respect. It has to be earned.

There has been a strong call for the British Armed Forces to intervene. I envisage they will have to wrap cotton wool around their weapons and any 'plastic bullets' will be exchanged for bullets made from marshmallows.

Meantime, local businesses are losing their livelihoods, property is being damaged and police officers are working 17+ hour shifts, armed only with a shield to fend off the bricks and bottles thrown at them.

So, what is the answer? Do we all sit around tables and work out our differences? Do we acknowledge that there is a problem policing the UK or do we strip the police 34,000 officers?

Last night youths approached the lines of officers, they goaded them. Why? Because they could. To make an arrest would see, at the very least, a couple of officers pulled from the front line - the endless hours of paperwork to secure a prosecution that would more than likely end up in a slap wrist is utterly ridiculous.

There are some quarters calling for national service - no thanks. I would much prefer people in the army and not animals.

It's time to flex the muscle - send in the army, let them do what they are trained to do. Someone only has to break wind in Belfast before the water cannons and plastic bullets are called for, why are we any different?

The Home Secretary, Teresa May, has claimed we don't need water cannons or the assistance of the British Army. This video suggests otherwise.
 




Rant over.

Fid


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Monday, August 08, 2011

Riots/Looting Spreads to Birmingham

See - Is It Time For the Army To Step In?

Fresh reports coming in of looting in Birminghm city centre.

Twitter is awash with updates, some false, some genuine.

Recent photo's are also surfacing at http://birminghamriots2011.tumblr.com/

Image: http://birminghamriots2011.tumblr.com/

Image: http://birminghamriots2011.tumblr.com/
Image: http://birminghamriots2011.tumblr.com/
Image: http://birminghamriots2011.tumblr.com/
I can't really see that this has anything to do with the shooting of Mark Duggan in Tottenham, north London. It's opportunistic youths who wish to take what doesn't belong to them.

The police, it appears, have a long night ahead of them.

I think the answer is pretty simple - send in the armed forces...and let them be armed.

The live pictures from parts of London today saw young men [animals] goading the police then throwing missiles at them. They [police] can only do so much - if they arrest an offender then the paperwork and logistics of such an arrest will leave them thin on the ground.

It's utterly ridiculous that one of the most highly regarded fighting forces in the world [the British Army] are not being called upon to, at the very least, assist the police.

The yobs must be so proud of themselves.

For the latest news on the civil unrest, I suggest Sky News

Fid


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The Goose That Laid The Golden Egg - Book Review




Doug Bremner's aptly titled second book, 'The Goose That Laid the Golden Egg', arrived in the post last week. A reader had kindly sent it to me after telling me how riveting a read it was...she wasn't wrong.

Bremner, a Professor of Psychiatry and Radiology and Director of the Emory Clinical Neuroscience Research Unit, lifts the lid on the way pharmaceutical companies protect their products at all costs, in this instance, it's Hoffman-La Roche, the manufacturers of the acne medication Accutane, known as Roaccutane in the UK.

After being approached to carry out a study on Accutane, Bremner finds his life turned upside down as he finds opposition to his findings that Roche's drug has a sinister side. Bremner goes on a journey that sees him called as an expert witness where he is grilled for hours on end in a 'breaking of the spirit' fashion by Roche's lawyers who cross examine him during deposition.

Bremner is as open as one can possibly be when writing. His story also deals with his deceased mother and his thirst to battle his demons in seeking her final resting place [she had died when Bremner was just 4 years old] and her biological family. The 'Goose' moves from Bremner's past and present in unrelenting fashion and highlights the mechanics of the human psyche when faced with the need for truth.

One feels for Bremner in his quest to bury his own demon and, at the same time, seek justice for those harmed by Accutane. It clearly shows that speaking out against the pharmaceutical industry can have dire consequences as lawyers pull out all the stops to try and discredit.

From the off Bremner lays his cards on the table and tells the reader how he was wined and dined by the industry with lavish trips and hotels thrown in for good measure. It's an insight into the internal workings of Emory, more importantly the free luncheon vouchers supplied to key opinion leaders in return for favourable reviews of pharma drugs.

It's a journey that sees a passionate man fall foul of dirty tricks and one which sees him fight for his own sanity, his quest for the truth and even his marriage.

The world needs more Doug Bremner's, his offering is, indeed, a golden egg.

'The Goose That Laid the Golden Egg' is available as both paperback and Kindle HERE and you can read more of Bremner's work on his website, 'Before You Take That Pill, HERE.

Fid


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Friday, August 05, 2011

Irish Hound Sniffs Out Paper Trail of Dr Harry Barry [Ireland]

Irish doctor, Harry Barry



Irish hound Leonie Fennell has been sniffing the paper trail left by Irish doctor, Harry Barry.

Leonie, whose son, Shane, took Cipramil [US Brand name - Celexa] for just 17 days before killing himself and another young man, is causing a bit of a stir within the dark walls of psychiatry in Ireland. Last month she was sent two letters from Brophy Solicitors who were representing their client, Patricia Casey [Psychiatrist]. Apparently Casey took umbrage to what Leonie wrote on her blog, leoniefennell.wordpress.com.

Today, Leonie has made some startling associations between Irish GP and author Harry Barry and Lundbeck, the manufacturers of the antidepressant Cipramil.

She has also made me aware of Lundbeck's "Mental Health Barometer” - Here's the blurb straight from Lundbeck:

Lundbeck Mental Health Barometer has researched Irish peoples’ attitudes towards depression, anxiety and mental health as well as the stigma and misunderstanding that pervades in this area.

As specialists in psychiatry, Lundbeck is committed to education and raising awareness through the provision of information which will enhance the perception of people living with mental health issues in the community.

The Barometer shows us that friends and family would listen and be sympathetic to someone with depression, but still view the GP as the best person to provide assistance. However, most people still find it difficult to discuss depression with a healthcare professional.

This research also confirms there is still a lack of understanding about depression and mental health in Ireland. In order to remove the stigma of depression we must undertake to educate about it – what causes it, who is affected by it and how it can be overcome. Only by bringing this conversation into the open can we hope to bring about real understanding of this condition.

I used to have an old weather barometer...that was never accurate either!

Her post and her announcement that she is to meet with Lundbeck officials, can be read HERE

In the meantime...

There will be a fair amount of cloud around for most places to start Friday morning. This will be breaking though and so some bright or sunny spells will be coming through for most. There is the risk of a few showers over western Ireland.....




Fid


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Thursday, August 04, 2011

Death by Effexor? - "Talk To Your Doctor"



I'm not surprised to see another pharmaceutical company rolling out the worn phrase, "Talk to your doctor." This time it's Pfizer covering themselves by using the classic buck-passing trend that attempts to bury the truth.

Amery and Christiane Schultz from BC, Canada are generating media interest with regard to the way their son, Matthew, died just two hours after being born. The Schultz family firmly believe his death was a result of Christiane taking Effexor during her pregnancy.

Health Canada, the Canadian medicines regulator, warned doctors in 2004 that SSRi/SNRi type drugs, such as Effexor, and cited "adverse effects" during the third trimester of pregnancy. The Schultz family were unaware of this warning, they, like millions of other Canadians don't tend to read the Health Canada webpage. Neither, it seems, did their doctor. When confronted with this information the Schultz family doctor told them, "I've never seen these before, I prescribe these drugs to women all the time and I've never seen these before."

Pfizer's response, ironically, is: "...Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during pregnancy."


It's hardly comforting is it?

A few weeks ago Amery wrote to the BC Premier, a letter that appears on his blog HERE. Despite what the reporter says in Video 2, Amery and Christiane have still not received a reply from BC Premier, Christy Clark.

Amery and Christiane are now spreading the word via the media in Canada.







Two Hours With Matthew Blog



Fid


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Wednesday, August 03, 2011

Dr. John Virapen, Eli Lilly and Prozac



Irish blogger Leonie Fennell has a fascinating post up regarding the SSRi Prozac [fluoxetine]

Her post focuses on a recently released video where Dr. John Virapen, who worked in the pharmaceutical industry for over 35 years, opens the seedy door to the psychiatric and pharmaceutical industry.

Leonie writes:

"I bribed the Swedish Government to get the licence for Prozac". These are the words of Dr. John Virapen who worked in the pharmaceutical industry for over 35 years. I have written about Dr. Virapen before because he told me about the corruption he got up to when he worked for Lundbeck. Anyway before he was employed by Lundbeck he worked for Eli-Lilly who are the manufacturers of Prozac. He refers to bribing Swedish officials because Eli-Lilly told him his job depended on it. He also says that the pharmaceutical industry have been buying doctors, picking them up in medical scool and paying their tuition to influence their prescribing.

He was at one stage in charge of a clinical study for Prozac in one of the largest hospitals in Stockholm. The first week of the trial two of the volunteers tried to commit suicide which he admits is a major side-effect of ssri medication.

He says that the pharmaceutical industry is now trying to target children with these drugs, Strattera, Prozac, Ritalin, Paxil, Zoloft, Ect. and that hand picked psychiatrists, paid for by the pharma industry, meet once a year to come up with new "disorders".

He says in one year 157 people were either killed or seriously injured by Strattera, among the victims was a 3 year old girl.

The video, which I have just watched from start to finish, is something that all readers of this blog should watch. It's a fascinating insight into the world of the psychopharmaceutical monopoly.

Leonie's post can be read HERE

In the meantime, take out 38 minutes of your time and watch this revealing video.






Fid


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Tuesday, August 02, 2011

Why Did the Children Cross the Street? - Because they didn't want to be diagnosed with ADHD



It appears those men in white coats will do anything to support the ADHD invention. The latest 'study' apparently shows children with attention deficit hyperactivity disorder [ADHD] have more trouble avoiding traffic when crossing streets than other children.

The cynic in me sees psychiatrists attending the bedsides of children knocked over by cars. "Once your child is on the mend Mrs Jones, we will see about putting him/her on some medication so he/she doesn't get knocked over again." The ambulance chasing lawyers really have their work cut out these days.

Researchers at Alabama University devised a computer-generated street intersection to see if 39 children, ages 7 to 10 with ADHD crossed the street less safely than 39 ADHD-free kids. They found that children with 'ADHD' looked both ways before crossing the street, just like the control group. The difference was that they opted to cross under more dangerous conditions.

Gadzooks! Those pesky little risk-takers eh?

More worringly, the study tells us that the children with 'ADHD' had their medication stopped 24 hours prior to the study. On this basis, researchers have deemed that those with ADHD are more likely to be involved in car accidents.

Here's an idea.

Why don't these researchers claim kids who miss a dose of their medications are more susceptible to road traffic accidents? They could then spin their findings and announce how important it is to take these mind-altering drugs!

For the love of God, why oh why are these white coated pill pushers always trying to find ways to convince themselves and parents that children need drugging?

This study is utterly ridiculous and deeply flawed.

I put it to Alabama University that these 'ADHD' kids were more than likely experiencing withdrawal, their senses were not heightened as much as the 'normal' kids.

Despina Stavrinos, co-author of the study and an assistant professor at the University of Alabama at Birmingham Injury Control Research Center, said she hopes to conduct a similar test with children while they're taking ADHD medication to see if their street-crossing behavior is any safer. She'd also like to follow the children into adulthood to study whether they become risky drivers.

I foresee a future where car accident victims legs and arms are put in plaster and their heads are bandaged. The doctor will do the hospital rounds and it won't just be pain-killers the child will be offered.

The world has gone crazy. The white coated pill pushers are part of that craziness.

Full article HERE.

**In other news:

Green Cross Code Man Loses Job


Fid


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Monday, August 01, 2011

DING DING: Marcia Angell v Psychiatry

Image: images.fastcompany.com


Back in June and July Marcia Angell wrote reviews for four books [one a manual] - each of her reviews was critical of the psychiatry profession and the way that antidepressant type drugs are dished out.

The reviews for all four publications appeared in The New York Review of Books, a fortnightly magazine with articles on literature, culture and current affairs.

Marcia reviewed:

The Emperor’s New Drugs: Exploding the Antidepressant Myth
by Irving Kirsch


Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America
by Robert Whitaker


Unhinged: The Trouble with Psychiatry—A Doctor’s Revelations About a Profession in Crisis
by Daniel Carlat


Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
by American Psychiatric Association

Daniel Carlat, author of Unhinged: The Trouble with Psychiatry—A Doctor’s Revelations About a Profession in Crisis, came under particular fire from Marcia Angell. So much so that he felt the need to respond to Angell's criticism.


To the Editors:

In her two articles, “The Epidemic of Mental Illness: Why?” [NYR, June 23] and “The Illusions of Psychiatry” [NYR, July 14], Marcia Angell takes aim at modern American psychiatry, and finds plenty of shortcomings. Her argument is correct in its essentials. Psychiatrists often overdiagnose disorders of questionable scientific validity, they have become overly fixated on medication solutions to life’s problems, and many have accepted a steady flow of drug industry money, creating so many conflicts of interest that it is impossible to know who we can trust.

But missing from her review is an unequivocal if perplexing truth about psychiatric drugs—on the whole, they work. Antipsychotics for schizophrenia, stimulants for ADHD, hypnotics for insomnia, benzodiazepines and SSRIs for anxiety disorders—in all these cases, drugs are robustly more effective than placebos in double-blind controlled trials. Even Robert Whitaker, in his Anatomy of an Epidemic, concedes that these drugs are effective in the short term—it is the potential long-term effects that he discusses. Whitaker makes the argument that used long-term, all psychiatric drugs are essentially poisonous to the brain and have led directly to skyrocketing rates of psychiatric disability. While his arguments are intriguing, I agree with Dr. Angell that there are significant weaknesses in the evidence he marshals.

Dr. Angell makes much of the fact that we do not understand the mechanism of mental illness, nor of the drugs we use to treat it. While this is true, it does not mean that the drugs are ineffective—only that as psychiatrists, we should stop overselling ourselves as possessors of a sophisticated neurochemical knowledge of our craft.

My chief criticism of Dr. Angell’s review is an uncritical acceptance of the premises in Irving Kirsch’s book, The Emperor’s New Drugs. Dr. Kirsch, in reviewing his lifetime of research on antidepressant efficacy, concludes that antidepressants are no more effective than placebo pills for depression. But his actual research demonstrates quite the opposite. In his meta-analysis of six drugs, he found that active drugs were, in fact, significantly more effective than placebo. Kirsch then dismisses this statistical difference as having no “clinical significance,” with which Dr. Angell concurs.

Other researchers disagree. For example, Erick Turner and colleagues (with no industry funding) conducted an even larger analysis, examining all available data, published and unpublished, on twelve of the most commonly used antidepressants. They found an almost identical benefit of drug over placebo as did Kirsch. While acknowledging that drug companies had boosted the apparent effectiveness of antidepressants by selective publication, they still found that, even including the negative data, all twelve antidepressants were statistically superior to placebo. Furthermore, in an editorial, they pointed out that Dr. Kirsch’s judgment about the lack of “clinical” significance was based on an arbitrary cut-off point suggested by the UK’s National Institute for Health and Clinical Excellence, a cut-off point with little if any scientific validity.

There is no question that among the medical professions, psychiatry is the most scientifically primitive. We have no more than the most rudimentary understanding of the pathophysiology of mental illness and we have resorted to tenuous and ever-shifting theories of how our treatments work. Dr. Angell’s review highlights these truths well, but at the same time gives short shrift to the very real benefits that we still provide our patients.

Daniel Carlat, M.D.
Associate Clinical Professor of Psychiatry
Tufts University School of Medicine
Boston, Massachusetts


Others to respond were

Richard A. Friedman, M.D.
Professor of Clinical Psychiatry
Director, Psychopharmacology Clinic
Weill Cornell Medical College
New York City

John Oldham, M.D.
President
American Psychiatric Association
Houston, Texas

and

Andrew A. Nierenberg, M.D.
Director
Bipolar Clinic and Research Program
Associate Director, Depression Clinical and Research Program
Massachusetts General Hospital
Professor of Psychiatry
Harvard Medical School
Cambridge, Massachusetts


There appears to be a game of ping pong going on here. One critic gives her views whilst her opponents return her serve with little, or no, meat behind their return of service.

It's fascinating to read MD''s, professors and psychiatrists offer opinion...because at the end of the day, that's really all their whole profession is based upon.

One only has to pick up a copy of the Diagnostic and Statistical Manual of Mental Disorders [DSM] to see how utterly absurd some of the invented disorders are.

I do have to applaud the aforementioned for going public with their beliefs, quite often the field of psychiatry digs itself an even deeper hole when trying to protect their theories. It remains to be seen if that is the case here.

I have asked many times what the benefits are of taking antidepressant medication. Carlat's last line goes someway to answering that question but again, it's just a personal opinion. He writes: "Dr. Angell’s review highlights these truths well, but at the same time gives short shrift to the very real benefits that we still provide our patients."

He failed to clarify what the benefits actually are.


Marcia Angell has, as one would expect, come back with a rebuttal. It makes fascinating reading and I'm sure will add further fuel to the psychiatry fire.

Her response to the criticism can be read, along with letters to the Editor from Carlat etc, HERE

Fid


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