Monsanto Roundup Lawsuit


Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Saturday, December 28, 2013

Top 12 Posts of 2013




Another year of blogging and the views have increased considerably. I'm not all that far off a million hits now, I still find this hard to take. I'm just a normal guy with a gripe.

Anyway, here's 12 reasons why you all kept coming back in 2013.

For Claudette - Rest In Peace



January - Tenacity Pays Off For Swedish Journalist Larsson

February - Psychiatric Medication or Play Therapy?

March - Sometimes the New Zealand Government Get It Wrong

April - Global Medical (Mis) Information

May - Reporting Adverse Events to Pharmaceutical Companies

June - FDA Approve Re-badged Paxil for Hot Flashes

July - Witty Plays Down China Scandal

August - Witty Witty Bang Wang. The Glaxo Gangbang...Allegedly

September - GSK - A Runaway Train...Running Right Off The Track

October - Mylan Pharmaceuticals: "Make My Baby Come Alive"

November - ADHD - Making the invisible visible

December - Citalopram Birth Defects (Guest Post)


As long as you keep on coming back, I'll keep on writing.

Have a Happy New Year folks and thank you for reading.


Bob Fiddaman.


Tuesday, December 24, 2013

Merry Christmas




Christmas wouldn't be Christmas without the obligatory Christmas message. It's hard these days knowing what to say without causing offence. Someone sent me the following which I found rather amusing.

"Wishing you a merry politically-correct non-denominational 'Winterfest'-type holiday, and a happy new Gregorian calendar reset."

Very clever and, one has to say, non-offensive.

I hope to publish a story I've been sitting on soon. It's a real eye-opener regarding GSK and their American lawyers, King & Spalding. I won't be accusing them of anything, I'll merely be throwing some questions out relating to fraudulent concealment. It will be up to you, the readers, to decide whether or not you think GSK and King & Spalding play fairly.

Anyway, until then...

Have yourselves a great Christmas.


Bob Fiddaman


Friday, December 20, 2013

Christmas Message For GSK and Their Attorneys

Christmas message for GlaxoSmithKline and their attorneys, King & Spalding...





HO! HO! HO!


Bob Fiddaman

Thursday, December 19, 2013

The Lundbeck Emails [Citalopram Birth Defects]



Two weeks ago Cheryl Buchanan wrote a guest post for this blog entitled 'Citalopram Birth Defects'.

Cheryl told how, after just 12 weeks, she was informed that the child she was carrying had a series of anomalies. Cheryl wrote:

The most severe of which included suspected diaphragmatic hernia or eventration, long bone immobility (I had never felt her move but as this was my first pregnancy I didn't know, I had nothing to compare it to), a cystic hygroma, unilateral cleft hand and microgynathia. I was also told that she might have brain damage which would explain the fact she didn't (or possibly couldn't) move.

Lundbeck are the manufacturers of citalopram, also known by its brand names Cipramil and Celexa, and Cheryl felt compelled to write to them for answers. Who can blame her?

I'm publishing Cheryl's emails with her permission. I don't need permission to publish Lundbeck's responses.



Nov 4 - Cheryl to Lundbeck

Dear Sir or Madam,

I am contacting you regarding the death of my daughter in 2004. I was taking citalopram at 60mg and became pregnant, I was told to continue the citalopram (it's physically written in my medical records) and as such my daughter whom I was pregnant with developed major abnormalities which meant she was incompatible with life. She died at 23 weeks gestation as I had to have a feticide procedure and induced Labour. I have recently come to believe upon gaining access to my medical records that citalopram was to blame and I have several questions I would like to ask your company. If someone could reply to me I would be very grateful, I plan on acquiring as much information as possible and have done a lot of research and spoken to other people who's families have been affected by citalopram. I have also spoken with some journalists who, if I give consent, plan on publicising my case in the newspapers in Scotland. I hope lundbeck are going to take my questions and claim that your drug was to blame very seriously. My daughter is dead because of this and I will not stop until I get the answers I deserve.

Cheryl Buchanan
File(s) attached

----

Nov 5 - Lundbeck to Cheryl

From: UKInfo@Lundbeck.com
To: REDACTED
Date: Tue, 5 Nov 2013 18:04:37 +0100
Subject: FW: Email sent from Lundbeck.com

Dear Ms Buchanan

I am just following up concerning your recent email to us on.  You mentioned that you had a number of questions you'd like us to respond to, however, as yet we haven't had an email from you with the questions on, and I was just wondering if this had gone astray on its way to us?  If you send any future emails or request to our Medical Information mailbox in the UK (ukmedicalinformation@lundbeck.com) we will be happy to address the points that you needed information on.

We can understand your reluctance for us to write to your doctor at this time.  However, I wonder if we could ask for one small piece of information?  In your email to us at the end of last week, you mentioned that when you obtained your records your doctor had reported the case to the MHRA.  Would you happen to have a case reference number for this that would be possible to let us know at all?  As mentioned in my email of last week, we do treat any report of unwanted effects seriously and have a obligation to also follow them up and obtain as much information as possible.

With kind regards

Medical Information Manager

Lundbeck Ltd, Lundbeck House
Caldecotte
Milton Keynes
BUCKS MK7 8LG
Tel: 01908 638972
Fax: 01908 372967

----

Nov 8 - Cheryl to Lundbeck

From: REDACTED
Sent: Friday, November 08, 2013 3:10 PM
To: UK Medical Information
Subject: RE: Email sent from Lundbeck.com

Dear Lundbeck, these are the questions I would like answered with regards to my daughters death while taking Citalopram.

1. Were Lundbeck contacted by the MHRA after being sent the Yellow Warning card by my consultant at the Princess Royal Maternity hospital in 2004?

2. What is the process when an adverse reaction of this nature is reported to Lundbeck?

3. Do Lundbeck ever follow up these reports and, or, contact the patient involved?

4. In the time leading up to 2004 (the year of my daughters death) there were 16 adverse reactions reported for congenital and familial /genetic disorders.

By September 2013 according to the D.A.P. for Citalopram the reported side effects of congenital disorders had risen to 82. 5 of these cases were stated as "fatal".

Also in the "pregnancy" section of the report 6 fatalities implicating citalopram were also recorded. So, according to the information stated in the D.A.P. Citalopram was an indicated factor in the death of 11 babies. One of which being my daughter. Very sadly, I also read that there were 20 "spontaneous abortions", four premature birth ands 2 still births. So that brings the total to 13. This is only the totals of cases which have been reported through the yellow card system to the MHRA, what about the cases that do not get reported, for instance if the woman was only on citalopram in early pregnancy, for example up to 4 - 6 weeks, finds out she is pregnant, stops this drug but subsequently in later pregnancy finds there is fetal abnormalities or that their baby has passed away. Do you have any idea, on average, of what percentage of suspected adverse affects are reported by the primary caregiver of the woman? There must be many cases where the medication was stopped very early on and then if abnormalities are found the drug citalopram is not indicated as it was stopped earlier in the pregnancy or, even if it was suspected, it was not reported to the MHRA. I understand it is not compulsory.

5. Has Lundbeck recently done, or plans to carry out, any studies into the iatrogenic affects of their medication?

6. If Lundbeck believe that citalopram does not cause birth defects then why have warnings been been introduced into the P.I.L.?

"When taken in pregnancy, particularly in the last 3 months of pregnancy, medicines LIKE citalopram may increase the risk of a serious condition in babies, called Persistent Pulmonary Hypertension."

PPHN is classed as a birth defect or congenital abnormality. My daughter suffered from Pulmonary Hypoplasia due to Diaphragmatic Hernia. This is closely associated with PPHN.
 
According to the website ChildrensColarado.org
       
"PPHN sometimes develops as the result of another event during delivery or from a disease or congenital condition affecting the newborn (usually one that either directly affects the lungs or oxygen supply to the baby before or after birth)."
       
"Certain congenital conditions that result in immature or incomplete lung development (such as diaphragmatic hernia) may also be associated with PPHN."
 
So basically, you could say by theory of logic, my daughter had no diaphragm and her lungs were less than a third of the size they should have been for her gestation, this would have more than likely caused PPHN, which is stated on your P.I.L. as being an "adverse reaction" to your medication Citalopram. So not only did your medication cause my daughter not  to develop normally, (which isn't really suspiring considering I was told to stay on it and at a dose of 60mg which is horrendous to think about), it would have contributed to my daughters demise had she been born alive. Neither myself or my partner have any history in our families of miscarriage, still birth or congenital (or hereditary) abnormalities or syndromes. As my daughters Karotype was normal this rules out tow of the three main factors. The last one is environmental which would include subjecting the much loved and wanted fetus, growling in my tummy, to a horrific amount of serotonin, an amount which has been proven to be unsafe in fully grown adults. Do you have an explanation for this and why it was deemed to be safe for a pregnant woman when it is not prescribed to adults at this dose anymore? I was not informed of any side effects of this drug by anyone, at any point in my care, I was told it was safe by numerous healthcare professionals.

7.  I have read a lot about the "benefit outweighing the risk". I don't see how a mother, whoso depression has been under control for a long time, she is happy and looking forward to the birth of her newborn, can benefit by being prescribed a drug, which then goes on to cause major abnormalities, weeks of tests, scans and hospital visits, all the while being absolutely devastated and clinging on to every hope her child would be OK and spending every night forcing herself to stay awake as she was so scared her baby would die, talking and singing to her baby, telling her baby how much she loved them and how sorry she was that she could not protect her baby, Contacting specialists in hospitals all over the UK to finally have to death with the death of her child and go through induced labor knowing that her child is dead, and then to see all of the malformations her beautiful angel had, and to have to live with the loss and huge hole in her heart every second of every day, blaming herself, torturing herself with guilt... What benefit did citalproam give this mother. I know the answer. None, that mother is me. This drug destroyed my daughters life and left an irreplaceable whole in my heart which will never heal until I join my daughter in heaven. So please, tell me again, what was the benefit?
   
I would be very grateful if you could answer my questions as honestly as possible, but to be honest I don't hold out much hope. I just want you to understand the "adverse reaction" your drug has had on my life.
   
I have lived with this "adverse reaction" every day for the past nine and a half years and will continue to live with it till the day I die.

Cheryl Buchanan

----

Nov 8 - Lundbeck to Cheryl

-----Original Message-----

From: UK Medical Information
Sent: 8 Nov 2013 16:58:05 GMT
To: REDACTED
Subject: RE: Email sent from Lundbeck.com

Dear Ms Buchanan

A quick note to confirm that I have received your questions this afternoon. I have forwarded these on to our global safety team at our headquarters in Copenhagen, and we will give these our full attention and should be able to get back to you with a response, early next week.

With kind regards

Karen Warrillow

----

Nov 13 - Cheryl to Lundbeck

From: REDACTED
Sent: Wednesday, November 13, 2013 5:24 PM
To: UK Medical Information
Subject: RE: Email sent from Lundbeck.com

Dear Lundbeck,

I am writing to ask if there has been any response from your safety team in Copenhagen yet? The reason I ask is you had stated in your last email to me that I would receive a reply early this week, tomorrow is Thursday and I am very anxious for a reply. I have been speaking with the MHRA and UKTIS and I am awaiting a response from them too. If it is going to take longer than first anticipated that is not a problem but either way if you could let me know what's happening I would really appreciate it, thank you.

Cheryl Buchanan

----

Nov 14 - Lundbeck to Cheryl

From: UK Medical Information
Sent: 14 Nov 2013 09:47:06 GMT
To: REDACTED
Subject: RE: Email sent from Lundbeck.com

Dear Ms Buchanan

I apologise that I have not been able to be in touch as I had hoped, earlier in the week.  I am still awaiting for some information from our global team and also from the MHRA in order for us to be able to fully answer your questions.  I would hope that I should receive this information later today, so I can put the information together and send a response to you tomorrow.

Karen Warrillow
Medical Information Manager

Lundbeck Ltd, Lundbeck House
Caldecotte
Milton Keynes
BUCKS MK7 8LG
Tel: 01908 638972
Fax: 01908 372967

----

18 Nov - Cheryl to Lundbeck

From: REDACTED
Sent: Monday, November 18, 2013 12:21 PM
To: UK Medical Information
Subject: RE: Email sent from Lundbeck.com

Dear Lundbeck,

I am writing to ask if there has been any progress on your reply to me regarding the questions I had sent you? I don't like to keep bothering you but I was told I would have had a reply by early last week. I know you were waiting on information and was wondering if you received it yet? If not that's fine but I am suffering from quite a lot of anxiety at the moment, due to this situation and also the fact I am trying wean myself off of an antidepressant as I will not be a hypocrite and take something which more than likely caused my daughter's problems. Having been on prescribed anti depressants since the age of 14, and only having stopped them for the period of my second pregnancy, that is 20 years I have put this medication into my system and I do not know how well my brain is going to function but we shall see. I find it appalling, now knowing what I know about ssris, that I have been encouraged to take something for a "chemical imbalance" in my brain which has not even been proven to be a cause of depression ect. I am suffering with horrible withdrawal symptoms and if the medication can cause this upon stopping them then what must they be doing to your brain to cause this. If you could let me know if you have a timescale in which you plan to reply it would be greatly appreciated.

Cheryl Buchanan

----

18 Nov - Lundbeck to Cheryl

From: UK Medical Information
Sent: 18 Nov 2013 16:11:25 GMT
To: REDACTED
Subject: RE: Email sent from Lundbeck.com

Dear Ms Buchanan

Please forgive the further delay in getting information across to you.  I have now received all the information back concerning your questions, and am just collating this for you.

I will make sure you receive a reply tomorrow.

With kind regards

Karen Warrillow

----

Nov 19 - Cheryl to Lundbeck

Date: Tue, 19 Nov 2013 15:33:53 +0000
Subject: RE: Email sent from Lundbeck.com
From: REDACTED
To: UKInfo@Lundbeck.com

Hi, just wondering if you have gotten any further on with regards to a reply to me questions?

Cheryl

----

Nov 20 - Lundbeck to Cheryl

-----Original Message-----

From: UK Medical Information
Sent: 20 Nov 2013 17:18:08 GMT
To: REDACTED
Subject: Information relating to citalopram (Request ID 0005-8858, UK 8637)

20th November 2013

Dear Ms Buchanan

Thank you for your recent emails.  Firstly, I would like to say how saddened we were to hear of your experiences.  I have addressed the questions that you raised, and hope that the information below helps to clarify things.

The methods of collecting and reporting safety data about medicines available in Europe are governed by Pharmacovigilance Regulations issued by the European Medicines Agency. I am sure you will probably have already done this, but you might find it helpful to have a look at the MHRA's information on the Yellow Card Process; this includes information on how reports are handled and what is done with the reports. This can be found at the following link; http://yellowcard.mhra.gov.uk/faqs/ .

Adverse events assessed as 'serious' reported by healthcare professionals and patients to the MHRA via the yellow card system are normally forwarded to the company responsible for inclusion in the company's safety database. The reports are anonymised by the MHRA before forwarding to us, so we are unable to then make contact with the patient concerned or the reporting healthcare professional. All pharmaceutical companies also have a process in place to forward on to the MHRA any reports received directly from healthcare professionals or patients . We also collect information on any cases of exposure to medicines during pregnancy, and whether or not problems are reported.

Periodically, at intervals specified in the safety regulations, companies must also submit a summary report of all safety-related information which has come to their attention, including reports of usage in pregnancy, to the regulatory authorities in the countries where a product is available (i.e the MHRA for the UK). The authorities review this information and make recommendations on whether the prescribing information (SPC & PIL) should be updated to include any information on newly identified possible side effects. The authorities may additionally sometimes request that SPCs are updated to incorporate new information which comes to light in the published literature about the medicine or similar products . In this way the SPC is a living document which at any one time reflects the currently known information about a medicine.

When looking at the figures provided in the Drug Analysis Prints (DAPS) on the MHRA website, it is very important to be aware that the figures listed are not necessarily cases where the event is specified as being causally-related to the medicine in question, in this case citalopram. The MHRA state themselves in their guidance notes about DAPS; "The fact that a report has been submitted does not necessarily mean that the medicine has been proven to cause a reaction." The listings do not provide further information about the cases reported which also need to be taken into consideration, such as any medical conditions the patient might have or details on other medicines taken, or take into account the likelihood that all of the events listed are also reported in the general population.

To put this information into context a little we know that worldwide more than 140 million patients have been treated with Lundbeck-manufactured citalopram over a 20-year period (and many more when generic preparations are included). This large volume of data includes cases of usage in pregnancy and through our frequent analysis and evaluation of this data reported to the company, and regularly forwarded to the drug regulatory authorities for their assessment, there is no evidence to indicate that usage of citalopram in pregnancy increases the risk for birth defects over the background risk. There are a number of reviews which have been published in the scientific literature which support this finding.

You are correct in stating that fairly recently we have added information on PPHN into our leaflet for Cipramil. This occurred in July 2010 and was the result of an assessment by the European Regulatory Authorities who evaluated three new epidemiological studies published in the scientific literature. These evaluated the pattern of PPHN occurrence across large defined populations and generated evidence to support the conclusion that the use of SSRIs in pregnancy, particularly in the later stages, may increse the risk of PPH in the newborn. PPHN may be casued by a number of factors, not necessariliy related to malformations and although the risk of PPHN is still very small, the risk is slightly increased in babies born to mothers taking antidepressants, such as SSRIs. Consequently the same wording was introduced to the pregnancy section for all the SSRI medication leaflets and SPCs in 2010. This quantifies the risk for clinicians and patients to try to assist decision making and is an example of the product information developing as more becomes known about a medication over time.

Medical treatment of pregnant women will always produce challenging clinical judgements, and whether or not to take a medication during pregnancy is a complex decision. A body of literature has now been published discussing the benefits and risks of antidepressants treatment during pregnancy. It should be kep in mind that depression and anxiety in pregnancy are risk factors for adverse outcomes for both mothers and their newborn children. It is also now known that untreated depression can itself affect neonatal growth and has also been linked to e.g. miscarriage, preterm birth, and impaired foetal and postnatal development.
As we mentioned in my earlier email, it would also be most helpful if you would report your experiences. I have re-attached a consent form for you to sign and return to us. If you do not wish to do this directly to us, you could submit a yellow card report yourself directly now to the MHRA via their website; http://yellowcard.mhra.gov.uk/. If you do this, if you quote the Reference ADR 10748808, they will add this information to the original record that was reported in 2004.

Kind regards
Karen Warrillow
Medical Information Manager
Lundbeck Ltd, Lundbeck House
Caldecotte
Milton Keynes
BUCKS MK7 8LG
Tel: 01908 638972
Fax: 01908 372967

----

Dec 12 - Cheryl to Lundbeck

Date: Thu, 12 Dec 2013 10:11:26 +0000
Subject: RE: Information relating to citalopram (Request ID 0005-8858, UK 8637)
From: REDACTED
To: UKInfo@Lundbeck.com
CC: REDACTED

Dear Lundbeck,

Thank you for taking the time to reply to the question I posed to yourselves. I do not, however, feel that any of them were clearly answered, in fact all of the information you stated I had already found for myself by researching online. I do understand that you cannot admit any facts that can be used to hold you responsible for my daughter's death but I did expect, considering the time you took to respond, that there may have been something which was new to me.

I have asked the MHRA under the freedom of information act for all correspondence between them and yourself in which my name is mentioned. I would like to ask if the MHRA have contacted you recently about my case I have submitted yet another yellow card.


In response to the following statement,

"When looking at the figures provided in the Drug Analysis Prints (DAPS) on the MHRA website, it is very important to be aware that the figures listed are not necessarily cases where the event is specified as being causally-related to the medicine in question, in this case citalopram. The MHRA state themselves in their guidance notes about DAPS; "The fact that a report has been submitted does not necessarily mean that the medicine has been proven to cause a reaction." The listings do not provide further information about the cases reported which also need to be taken into consideration, such as any medical conditions the patient might have or details on other medicines taken, or take into account the likelihood that all of the events listed are also reported in the general population. To put this information into context a little we know that worldwide more than 140 million patients have been treated with Lundbeck-manufactured citalopram over a 20-year period (and many more when generic preparations are included). This large volume of data includes cases of usage in pregnancy and through our frequent analysis and evaluation of this data reported to the company, and regularly forwarded to the drug regulatory authorities for their assessment, there is no evidence to indicate that usage of citalopram in pregnancy increases the risk for birth defects over the background risk. There are a number of reviews which have been published in the scientific literature which support this finding."

I would like to clarify your position, are you telling me that citalopram was not to blame for any of the cases referred to in the DAP?

I would also like to invite you to read a guest blog I wrote for Bob Fiddaman's blog? I will pop a link for you below. If you would like to reply on the blog please feel free to leave a message.

http://fiddaman.blogspot.co.uk/2013/12/citalopram-birth-defects-guest-post.html


I will be cc ing Mr Fiddaman in on all correspondence from now on. I hope that is not a problem.

Cheryl Buchanan

----


Lundbeck have yet to reply.

I think it's important that we, as patients, query the drugs we are given when things go wrong. In Cheryl's case she lost a child. She has a right to question Lundbeck as they made the drug that Cheryl claims caused the birth defects.

It's also important to post emails publicly because other women who have taken citalopram and whose children were born with defects or whose pregnancies were terminated may just make that link and may also start to throw questions at Lundbeck.

Without mothers coming forward and reporting their adverse events to Lundbeck they can always turn a blind eye to something that has been staring them in the face for many years. Lundbeck, just like their rivals GlaxoSmithKline, have produced a drug that can cause birth defects. Instead of warning the public they choose to send meaningless emails to those whom question their drug. So be it. The more uncaring and meaningless emails they send, the more uncomfortable questions they will have thrown at them.

Cheryl is a tenacious woman. I think she is going to be around for a very long time. I think she is going to keep on asking Lundbeck those uncomfortable questions. I think she's right.

Bob Fiddaman


Speaking of emails...

I've been sitting on some Paxil ones for a few days. I'll release my findings soon.






Wednesday, December 18, 2013

Superior Court Sides With GSK [Paxil Birth Defects]



Paxil birth defects.



This is wrong on so many levels...

A state appellate court panel has sided with pharmaceutical giant
GlaxoSmithKline in a Paxil wrongful death claim that had been filed by a woman who maintained she was essentially forced to have an abortion because her unborn child developed severe, in-utero birth defects due to her use of the antidepressant medication during pregnancy.
In a non-precedential decision filed on Nov. 27, the three-judge Superior Court panel wrote that a Philadelphia Common Pleas Court judge was correct in July 2012 to issue summary judgment to the drugmaker in a case initiated by Joanne Thomas on behalf of her deceased child, Ryan Swindle. [Source - Pennsylvania Record]

Want to know why it's wrong?


I'm about to drop a bombshell for GSK and their attorneys, King & Spalding, something I'm sure they are already aware of as they searched frantically through a series of Paxil posts on this blog 5 days ago. [Fig 1]



Fig 1


All one had to do was join the dots...but nobody did... until now.

Who was it that said GSK's history of fraud and concealment was just part of an era?

Funnily enough, I was prepared to let this go but Glaxo, it appears, just don't want to play ball with a woman they have known for some time, 2001 to be precise.

Stay tuned for the exclusive.

Meantime here's some food for thought for King & Spalding.







Bob Fiddaman.






Child Medication [ADHD] Linked to Sexual Organ Abnormalities




So, we know about Risperdal causing breast enlargement in boys. Janssen's own clinical trials, with just 1,885 children, showed that 43 of them developed abnormal breasts. [1]

Now we learn that boys, such as the four year-old who developed a breast on one side and began producing milk, are at further risk. This time, we are told, it's priapism, a condition that can permanently damage a patient's penis.

So, let's just get this straight.

Using psychiatric medication in children can cause suicidal thoughts, completed suicide, abnormal breasts in boys and now permanent penis damage.

If that wasn't enough we already know that these drugs, when taken by pregnant mothers, can cause birth defects. If your child is lucky enough not to develop birth defects in the womb then they can die from overdose when ingesting breast milk from their mother.

That some huge net pharma have cast out.

Psychiatry and Pharma must be very proud of themselves.

Who needs birth control pills when psychiatric medication does pretty much the same thing.



Priapism story here


Bob Fiddaman


[1] The New Drug Of Choice - CBS Video - May 2009

Tuesday, December 17, 2013

GSK: No More Payments to Doctors




Photoshop of Glaxo Chief Andrew Witty with a Cleft Palate, one of the many birth defects associated with Paxil [Seroxat]

Hardly surprising that Glaxo chief, Andrew Witty, has recently claimed that his company will [ahem] no longer pay doctors to promote its drugs, is it?

They are currently under investigation in China for doing just that.

Witty made the announcement in a phone conversation with the New York Times according to journalist Katie Thomas.

Wow, an announcement in a one on one phone conversation. Way to go Andy baby.

Witty, who recently flew to China with British PM David Cameron to convince the Chinese to trade with Britain, has come under fire many times, from me at least, for his excuses for Glaxo's past history of off-label promotion and failure to warn the public about Glaxo's unsafe drugs causing addiction, suicide, heart strokes and birth defects.

"All part of an era" was Witty's lament, an era that he was very much part of. Just ask the Whistleblowers in the recent $3billion dollar lawsuit.

There are many that suggest that I should give Witty a break. Hey, he's trying his hardest to be as transparent as possible. Yeh, right, maybe he should start by correcting the wrongs from the "era" he uses in his excuses.

A retraction of the embarrassing fraudulent clinical trial results of the Paxil pediatric studies would be a good start. Then maybe he can move on to the adults currently pursuing GSK through the British courts who claim that Paxil [known as Seroxat in the UK] caused them a whole host of withdrawal problems (including addiction) - something his company never warned them about.

There's also a number of Paxil birth defect cases to be settled, maybe instead of settling Witty should apologise to the kids born with heart defects because of their mothers ingesting Paxil during pregnancy. Maybe offer condolences to those who had to terminate pregnancies because his company failed to warn them of Paxil's teratogenic effects on the fetus, be it a viable or [ahem] non-viable fetus.

Just because the above didn't happen on Witty's watch should not make him shirk his responsibilities. He knew what he was taking on when Garnier handed over the reigns to him. If the Frenchman was not prepared to apologise to all those his company's drugs have harmed then maybe Witty should swallow his pride, ignore what his attorneys tell him and just apologise for the appalling behaviour of GlaxoSmithKline.

Glaxo have claimed that under their new plan, which would be completed worldwide by 2016, they would no longer pay key opinion leaders to speak on its behalf about its products or the diseases they treat “to audiences who can prescribe or influence prescribing,”

Full story here.

In other news...

Cat shocks judges by playing fiddle, a cow jumps over the moon and scientists baffled at dog laughing.


Bob Fiddaman





Monday, December 16, 2013

Tenacity Pays Off For Irish Mom.



Leonie and I. A friend and fellow ass-kicker.




I just love it when the David's are recognised.

I just love to see the Goliath's put firmly in their place.

Irish mom, blogger, law student and thorn in the side of Lundbeck, Leonie Fennell, has just been honoured by the Well-Being Foundation...and rightly so.

The Well-Being Foundation have given Leonie an award so richly deserved for her work in the field of creating drug awareness. Woman of the Year is quite an achievement when one takes into account the brick walls Leonie has been faced with when trying to unearth the truth.

She's swallowed hard and met with Lundbeck officials where she grilled them about their antidepressant Cipramil [known as Celexa in the US] - She even secretly recorded this meeting! Video footage here, audio footage here.

She has met opposition, in the form of threatening attorney letters, from Irish psychiatrist Patricia Casey, yet still she continues her pursuit for the truth.

Leonie and I first met a few years back. She and her husband Tony relayed their story to me about their son, Shane. We have since met up a further 3 times where I have met her wonderful family and circle of friends.

I have watched from a distance and witnessed a truly great woman take on the might of the pharmaceutical industry. I have nothing but sheer admiration for any person that shows the strength and courage that shows the world that they will never take things lying down.

Leonie has stood up - she has been counted.

One word.

Proud.

Here's a Podcast I did with Leonie back in 2011.





Leonie Fennell Blog


Bob Fiddaman




Friday, December 13, 2013

Paxil Birth Defects Teaser.





For King & Spalding.

I don't particularly like GlaxoSmithKline or their attorneys King & Spalding. This is for them both. I think they should know by now what it is in reference to.

Let's give the little guy some respect here. Let's give his mother some respect too.

Merry Christmas Y'all.






:-)

Bob Fiddaman








Thursday, December 05, 2013

Citalopram Birth Defects (Guest Post)



Pictured - Scottish Mom Cheryl Buchanan



For the past week or so I have been speaking with a mother who terminated her pregnancy because she was told her fetus had severe birth defects. That woman, who at present I can't name, was taking Paxil. It's a future story for this blog.

About two weeks previous to the Paxil contact, I received an email from Cheryl Buchanan, another mother who had a similar story to tell, this time the drug involved was another SSRi, citalopram, also known as Cipramil and Celexa.

I asked if she would like to write a guest post for my blog, she agreed. I'm glad she did because she writes beautifully.

I really don't have much to add to Cheryl's story other than I admire her for speaking out. Far too many of these birth defect cases are settled by pharmaceutical companies in courts throughout the US. To bring such cases to Great Britain is notoriously difficult, such is the pharmaceutical industry's stranglehold on the UK government policy to fund such litigation.

In the US, the same pharmaceutical companies are sued, they settle with the plaintiff on the proviso that the plaintiff keeps quiet about the terms of that settlement. By keeping these 'gagging orders' in place it allows them to continue pushing the drug on pregnant mothers, it allows them to to quicken their pace to the end of the statute of limitations... meaning that no other cases can be brought against them.

By not allowing such litigation in the UK, or by the government putting blocks on legal funding for these types of cases it could just be the chink in the armour for activists like myself and for those who wish to seek justice.

No pharmaceutical company likes it when they are accused of putting pregnant women at risk, they don't like it when they are accused of forcing the hand of women to have abortions either.

I believe the following will help more and more mothers speak out.

This is Cheryl's story...

Bob Fiddaman.




"I will lend you, for a little time,
A child of mine, He said.
For you to love the while he lives,
And mourn for when he's dead.
It may be six or seven years,
Or twenty-two or three.
But will you, till I call him back,
Take care of him for Me?"

(A child of mine - Edgar Albert Guest)






God lent me my child, physically, for 23 weeks. Now she is back in the arms of the lord but also tucked away in my heart for eternity. She never got to take her first breath, I never got to see her smile or hear her cry. My child was born, and died, at 23 weeks gestation of pregnancy. I was told she had severe abnormalities which meant she  was incompatible with life. There was no explanation as to why it might have happened, the words "it just wasn't meant to be" did not console me, they angered me. Why did God choose my child, what had we done to deserve this? I was so angry with God, but I placed blame for it on myself. I hated myself for failing my child. For nine years I gave myself hell, mentally berated and tortured myself. I thought if I stopped feeling so bad, my daughter might think that I didn't love her as much. Now I am suffering in a different way, I discovered not long ago that my child may have developed congenital abnormalities because of a medication called Citalopram, which I had been prescribed before and throughout pregnancy. Shockingly I also discovered that I am not alone and every day pregnant women are still being prescribed antidepressants.

Since I was a child I suffered from anxiety, as a teenager I was prescribed Prozac (Fluoxatine), due to being bullied at school. I took them on and off for a few years, my family went through a series of bereavements, I did not cope very well. I was admitted to a psychiatric unit 3 times at the age of 22. I was diagnosed with psychosis and Bi-Polar disorder. Looking back I know now it was caused by grief, I did not have Bi-Polar disorder. I was given the usual concoction of anti psychotic medications (Risperdal, Olanzapine,Effexor). I was unwell for around a year but got off of the medication, was in a good place mentally and had the support of my lovely partner. Then suffered more bereavement in our families. This time I did not let the grief overwhelm me as it had done before, this time we decided to do something to try bring some happiness back into our lives, we decided to try for a baby. I informed my GP who prescribed folic acid for me, I was also taking prescribed Citalopram, at a dose of 60mg, a dose which is no longer prescribed as its known to cause heart problems in adults. The GP told me it was fine to keep taking it so I carried on, completely oblivious to the damage I was about to do to my unborn child.

Within a couple of months I discovered I was pregnant,  the time flew in until the 12 weeks scan, I so exited to see my baby for the first time, I had no fears, didn't know that it was possible for things to go wrong, now I realise how incredibly naive i was. The sonographer was carrying out the scan, pointing out my daughters heart, head ect but then stopped and became very quiet, I asked what was wrong but she excused herself from the room, went to get a consultant to speak to me. That was the beginning of the end, after only 12 short weeks of existence they could already tell me daughter was very ill. The scan, and subsequent scans, detected a series of anomalies. The most severe of which included suspected diaphragmatic hernia or eventration, long bone immobility (I had never felt her move but as this was my first pregnancy I didn't know, I had nothing to compare it to), a cystic hygroma, unilateral cleft hand and microgynathia. I was also told that she might have brain damage which would explain the fact she didn't (or possibly couldn't) move.



The post mortem revealed half of my daughter diaphragm was absent, her lungs were very small, some of her organs had moved up into the thoracic region. Her neck had webbing, nose was small, chin recessed.  No one could tell me why this had happened, my consultant tried his best, geneticists looked at my files but no one had a reason why my baby's development had gone so catastrophically wrong. I was thoroughly reassured citalopram was not to blame. My daughter was cremated two weeks after her birth, it was all arranged by the hospital, we had a service for her at the crematorium and I will never forget the image of her being carried down the aisle in her coffin, going through the curtains to be cremated. I wanted to run over and stop them, grab my daughter and run away. Previously I hadn't thought it possible for any human to ever experience the amount of pain I suffered and survive.

After the cremation I was told to collect the ashes the following day, when I called I was told there were no remains. I was devastated, I just wanted something of her, something physical that said she had existed. In January of this year I found some news articles from Edinburgh that Mortonhall Crematorium had routinely been retaining baby's ashes, telling the parents there were no remains, then "interring" them in a field. Immediately I thought of my daughter, although I live in Glasgow I decided to try and find out if this practices had occurred here too. Quickly I discovered my gut instinct was right, I found other parents in Glasgow who had recently discovered their baby's ashes had to been returned to them and scattered by the staff at Daldowie Crematorium, the place my daughter was cremated. We have been working hard to convince the Scottish Government that a public inquiry is necessary, so far however, our pleas to The First Minister and Scottish Government, have fallen on deaf ears. At the moment Lord Bonomy is heading up a "Cremation Commission" looking into ways in which to change cremation practices in Scotland, also in Edinburgh Dame Eilish is carrying out an investigation into the practices at Mortonhall crematorium. Through my own investigation I asked the Princess Royal Maternity Hospital for a copy of my records from the time of my pregnancy. Now this is where the fun really begins.

Upon receipt of my records I noticed a photocopied page of something called a "Yellow Card Warning", it was sent by my consultant, to the MHRA, advising them of the outcome of my pregnancy and that i had been taking Citalopram. I was devastated when I looked through my records, I had to read through her post mortem, several letter from my consultant to geneticists and other information that realistically, I should never have had to see. I googled "citalopram birth defects" and was horrified to find that there were 385,000 search results, I also discovered the existence of Lundbeck, a Danish pharmaceutical manufacturer, the inventor of citalopram.

My blood was boiling, I had to do something so I contacted just about everyone and anyone who had a blog or website dedicated to the side effects of SSRI's. I was very lucky to have found some wonderful people, people who had suffered because of these drugs, people who had lost loved ones to them. I also contacted the Centre for Adverse reactions in Scotland (they were useless), Lundbeck were next on my list so I asked them series of questions, I don't think they answered even one of them. The majority of their reply was information I had already found on the internet, total garbage I could have copy and pasted myself. Once of the points I made to them was "My daughters lungs were a third of the size they should have been, she had pulmonary hypoplaisa due to diaphragmatic hernia. Pulmonary Hypoplaisa is a known cause of Persistent Pulmonary Hypertension of the newborn (PPHN), so its quite reasonable to say my daughter would have had this condition had she been born alive, had she had it, it would have been down to the citalopram." If this was to be the case then Lundbeck would have been held responsible, after all they have it stated on the Patient Information Leaflet the "SSRI medications of this type can cause PPHN". They dodged that question, just like every other one. To me, its blatantly obvious citalopram killed my child. Had she been born alive she would have not been able to breath and would have endured an intolerable amount of suffering. Lundbeck also said in their reply that when prescribing SSRI's in pregnancy "the benefit has to outweigh the risk". I do not believe, prior to my pregnancy, that I was suffering from depression, quite the opposite in fact. I would have happily stopped the citalopram had I been advised that it can cause birth defects. In fact with my second pregnancy, although I did not know anything about citalopram causing these problems, I stopped taking it the day I found out I was pregnant, I was not taking any chances. I now have a beautiful, healthy seven year old daughter but every so often I look at her and feel intense sadness at the fact I should have two children on earth with me.

At this moment in time I am a bit lost. I have been told that it will be very difficult to have a case against Lundbeck heard in court but that doesn't mean I cant try. I have to do something, my conscience wont sit still for a second, it always on at me to look for more info, ask more questions. At first I was in shock at all of this now I believe my child was "lent" to me for a reason. God must have known I would fight, not just on my own behalf but on the behalf of every parent and child affected by these drugs.  He must have known the intensity of the love I would have for her, I am very blessed and humbled that he chose me. My daughters death will not be in vain, I will not back down until those responsible are held to account. In may of next year some of the Class Action Lawsuits against Forest Laboratories (a license holder for citalopram in the USA) are due to begin. I am hoping this will shed more light on the ill practice of Lundbeck and Forest, I am hoping it will pave the way for parents like myself to bring similar actions in the UK. I want to make one thing clear tho, I am not doing this for money, it means nothing to me. All the money in the world wont bring my daughter back. What I want is for SSRI medications to be reclassified as a class D drug. Also an apology, an acceptance of guilt would be nice.

Guess I better not hold my breath...

Cheryl Buchanan

Glasgow, Scotland



Coming Soon - GlaxoSmithKline's attorneys, King & Spalding, argue a fetus is non-viable if under 23 weeks old. A truly shocking story of injustice regarding a mother forced to abort because of birth defects caused by Paxil.





Monday, December 02, 2013

Cronyism, Chinese Style





Cronyism - Favoritism shown to old friends without regard for their qualifications, as in political appointments to office.

British PM, David Cameron, is off to China, apparently he needs to drum up some business. It appears that the Prime Minister can't do this alone, he needs to convince the Chinese government that the UK are good guys to deal with.

So, who better to tag along with Cameron than his old chum, Andrew Witty.

Witty, whose company, GlaxoSmithKline, are currently being investigated by Chinese officials for corruption, bribery and other misdemeanors, is part of David Cameron's business council.

I find this really amusing. Here we have the leader of a country who wishes to convince Chinese officials that business with the UK is the way forward. To help convince China that the UK have wonderful business practices the UK bring along a knight, a sir, if you will, whose company, a British one, who are currently under investigation by Chinese authorities.

Laugh? I almost soiled myself!

However, this knight is not shining, in fact Witty must be cringing at the thought of being asked about Glaxo's behaviour in China. I can just imagine how the phone call between Cameron and Witty went. Maybe it was something like this...

DC - Hey, Andy me old mucka, DC here, you fancy an all expenses paid trip to China?

AW - Are you taking the piss, DC?

DC - No mate, honest, we seriously need to drum up some business and investors. The UK has pretty much had it and nobody really trusts me anymore, if you believe the polls that is.

AW - But you are aware the Chinese authorities are investigating my company, aren't you?

DC - Of course Andy but why are you worried about something so trivial, it never happened on your watch did it?

AW - No, and that's the position that I have taken. I would have used the era excuse but it was fairly recent and I just didn't think people would buy into it again.

DC - So, let's have dinner. I've invited some of our business greats along too.

AW - But don't you think it will be awkward for me if the press start to ask probing questions about the bribery allegations?

DC - Andy, Andy, Andy. C'mon, It's just a few bad eggs, don't stress my friend. Bring some Seroxat with you in case you get an anxiety attack.

AW - Sod that, have you seen what that shit does to kids?

DC - Just part of an era though, hey mate.

**Laughter**


Back stories on the China scandal below.

Bob Fiddaman


Witty Plays Down China Scandal

Witty Witty Bang Wang. The Glaxo Gangbang...Allegedly

Andrew Witty... I know narrrrrrrrthing

葛兰素史克公司 腐败 For Researching Chinagate

Glaxo's Private Investigator Arrested

Book Your Holidays With GSK Travel

Andrew Witty... I know narrrrrrrrthing - Part II

Hammer to Fall on GSK's Chinese Executives









Thursday, November 28, 2013

Adam Lanza and the GC/MS Screening Method




A few weeks ago I wrote about Adam Lanza, moreover, the secrecy surrounding his medical records. [See
Adam Lanza - Why the Secrecy Over His Medical Records?]

Lanza fatally shot twenty children and six adult staff members in a mass murder at Sandy Hook Elementary School in the village of Sandy Hook in Newtown, Connecticut. He then took his own life by shooting himself in the head.

Now, it seems, we can simply put to bed the link between Lanza and any medication he may have been taking prior to his murderous and suicide act, at least that's what the mainstream media are telling us.

There are many conspiracies that have evolved since Lanza killed himself and others. He never acted alone, he doesn't even exist, are just a couple of theories doing the rounds.

Quite often the truth is missed by misinformation. Now I'm not suggesting for one minute that the US government or the pharmaceutical industry would start such rumours but it's one we have to take on board if we are to get to the truth about Lanza and the treatment he was receiving.

Open the Lanza files and you are faced with the proverbial can of worms, with each wriggle and slither these worms are telling us that there is more to this than meets the eye.

A few days ago Connecticut authorities released a 44-page summary of their investigation into the Sandy Hook shootings, 'summary' being the operative word here because none of it really adds up, particularly with regard to Lanza and any treatment he may have been receiving.

By way of proving that Lanza wasn't on any medication at the time of his 11 minute rampage officials have released his toxicology report [Fig 1] which, bizarrely, is incomplete and, let's say, less than vigourous if we see the tests that were carried out during post-mortem.

Fig 1 - Click to enlarge
The cause of death was pretty obvious, Lanza shot himself in the head. As I am led to believe a medical examination would not routinely look for recent past use of prescription medicines including psych drugs where the cause of death is obvious.

If Lanza had abruptly stopped taking medication then this could have led to akathisia and rage, meaning that the parent substance may not have been detectable.

If we look at Fig 1 we can see the term 'GC/MS'. This stands for gas chromatograph/mass spectrometry. What it does not tell us, however, is the Limit of Detection (LOD) when using the GC/MS method.

A 2011 published paper by Thomas G. Rosano, Michelle Wood and Thomas A. Swift highlights just how limited the GC/MS test is when it comes to detecting medications.

The study, Postmortem Drug Screening by Non-Targeted and Targeted Ultra-Performance Liquid Chromatography–Mass Spectrometry Technology, was published in the Journal of Analytical Toxicology [1]

It showed that the detection sensitivity using the GC/MS screening method came in at just 71%.  However, when combined with other screening methods, the GC/MS performed much better. In Lanza's toxicology report we see no sign of any medication. We also see that the GC/MS screening method was used.

Let's just take you through some of their findings.

When using the GC/MS screening method no traces of Aripiprazole [Abilify] were found.

However, when they combined GC/MS with other screening methods they found 7 traces of Aripiprazole.



Here's some more.

Fluoxetine [Prozac]

GC/MS found 11. When combined with other screening methods 14 were found. In other words using the GC/MS screening method alone missed 3.

Nortriptyline [a tricyclic antidepressant]

GC/MS found 9. When combined with other screening methods 12 were found. GC/MS screening method alone missed 3.

Quetiapine [Seroquel]

GC/MS found 8. When combined with other screening methods 15 were found. GC/MS screening method alone missed 7.

Risperidone [Risperdal]

GC/MS found 0. When combined with other screening methods 5 were found. GC/MS screening method alone missed 5.

Trazodone, an antidepressant of the serotonin antagonist and reuptake inhibitor (SARI) class.

GC/MS found 10. When combined with other screening methods 17 were found. GC/MS screening method alone missed 7.

Lorazepam [Ativan] 

GC/MS found 1. When combined with other screening methods 2 were found. GC/MS screening method alone missed . [Just a 50% success rate]


So, the burning question here is why did Adam Lanza's medical examiner just use the GC/MS screening method?

Was it purely down to the fact that the cause of death was obvious so there was no need to determine if Lanza was on any particular type of medication? Was it down to cost? To run a combination of screening methods would cost a lot of money. Or, in Dr H. Wayne Carver [Chief Medical Examiner], do we have a professional who is already of the opinion that psychiatric medications do not cause homicidal and suicidal acts - ergo no reason to screen for specific medications using more robust screening methods?

The investigation [44-page summary] suggests that Lanza had "significant mental health issues". Such statements would suggest that Lanza was, or had at some point, been on medication.

Today we see some of the parents of those who died at Sandy Hook asking why Nancy Lanza [Adam's mother] didn't do more for her son. If the GC/MS screening method had been combined then maybe we might have been asking different questions. If Lanza's psychiatrist/psychologist were to step forward then maybe they could shed light on whether or not Lanza was, at any point, taking prescription medication.

Adam Lanza, like other school shooters before him, had, according to the mainstream press, mental problems. What exactly were those problems, what was he diagnosed with? Depression, Bi-Polar, ADHD, Aspergers? Which one of the many hundreds of psychiatric disorders show a symptomatic checklist that states "Patient may have the urge to kill his mom" or "Patient may have the urge to kill innocent adults and children then self".

The parents have a right to know and they have a right to call it as they see it.

Unfortunately using the GC/MS screening method as a standalone may be sending out the wrong messages and, once again, giving a clean bill of health to psychiatric medication. Or maybe we just need to convince medical examiners that there is an undeniable link to prescription medications and homicidal/suicidal acts.

It may be worth revisiting this post, if only to witness Assistant Attorney General for Connecticut, Patrick B. Kwanashie and his two minute performance captured on film. The whole reason why this video surfaced on youtube is explained in the post.



Bob Fiddaman







[1] Postmortem Drug Screening by Non-Targeted and Targeted Ultra-Performance Liquid Chromatography–Mass Spectrometry TechnologyJournal of Analytical Toxicology, Vol. 35, September 2011


Letters From Generation RX - Radio Interview



Kevin has been instrumental in creating awareness regarding the way psychiatric prescription medications are handed out willy-nilly to patients whom are rarely informed about the side-effects.

In Kevin's ground-breaking first movie, Generation RX, he showed the infiltration of the DSM and FDA by pharmaceutical companies and the volume of people who seem to be profiting from the sales of these drugs.


In this interview, from Truth News Australia, Miller talks about his new movie, 'Letters From Generation RX'.
It's well worth the listen particularly for the way Miller explains how people are targeted when they speak out against the pharmaceutical industry and psychiatry.







If you are having difficulty with the player then you can download the MP3 direct HERE


Kevin P. Miller can be followed on Twitter here and the 'Letters' Facebook page is here.



Bob Fiddaman



Related:

Exclusive: Interview With Kevin P. Miller (Letters From Generation RX)





Tuesday, November 26, 2013

ADHD - Making the invisible visible






ADHD - Making the invisible visible.

Quite a catchy title and one would expect anything that followed such a headline would be groundbreaking news.

In fact, the title should be ADHD - Making the backroom staff visible.

Alas, 'ADHD - Making the invisible visible.' is nothing more than an apparent  "Expert" White Paper on the 'disease' that nobody can see or prove yet is diagnosable and treatable.

The paper, we are led to believe, was put together by Susan Young (King’s College London, Institute of Psychiatry, UK), Michael Fitzgerald (Trinity College, Dublin, Ireland) and Maarten J Postma (University of Groningen, the Netherlands). I say 'led to believe' because we really don't know anymore if anything published by key opinion leaders is actually their own work. I guess we just have to accept that Young, Fitzgerald and Postma are the original authors and these are their own findings.

The paper, we are told, was "initiated, facilitated and funded by Shire AG and supported by the European Brain Council and GAMIAN-Europe (Global Alliance of Mental Illness Advocacy Networks.)"

We are also told that "Medical writing support was provided by APCO Worldwide and Complete Medical Communications, and funded by Shire AG."


Ah, I see. So, it probably was ghostwritten, right?

What exactly is "Medical writing support" and who, exactly, are APCO Worldwide and Complete Medical Communications?

APCO are an independently-owned PR firm in the United States who have an impressive list of former and current clients including, Bristol-Myers Squibb and Merck Sharp & Dohme.

Complete Medical Communications [CMC] are, in essence, a retail by proxy outlet for the pharmaceutical industry. A 2012 snapshot of their webpage clearly shows the service they offer:

"CMC is a leading healthcare communications company, in business for over 20 years. Over that time we have helped global clients negotiate an array of challenges along the drug-development pathway, combining tried and trusted approaches with fresh and creative ideas."


So, it's really quite easy to see why the financial backers of this paper, Shire AG, wanted CMC on board. CMC have nothing to do with diseases [ADHD is supposedly a brain disease.] By CMC's own admission they "negotiate an array of challenges along the drug-development pathway" - in layman's terms, they think of ideas to promote a drug without it actually looking like promotion.

Furthermore, CMC offer the following services:


  • Brand consultation at all phases of product life-cycle (pre-launch, launch, post-launch) 
  • KOL programs
  • Journal submissions and supplements 
  • Slide kits
  • Posters 



They also plan events for...


  • Regional, national and international meetings 
  • Advisory boards
  • Speaker tours 
  • Preceptorships 


Do Shire AG have any interest in getting this ADHD information out there to the masses?

You betcha.

Shire, market and manufacture Adderall, one of the most popular ADHD drugs in the world. The patent for Adderall expired in 2009 but it was soon back in the hands of Shire when, in 2011, they released Adderall XR (extended release) - basically, they changed a molecule here and there, rebadged the original Adderall and came up with Adderall XR.

Genius hey?

Not quite, we've seen this happen so many times with other drugs. Celexa patent runs out and Lexapro arrives [same drug] Wellbutrin patent runs out and Zyban arrives [same drug], Prozac patent expires and Sarafem appears to treat premenstrual dysphoric disorder, that's PMS to you and me. Prozac and Sarafem are the same drug. Eli Lilly saw sales of Prozac fall when the patent expired around 2001 so they, probably with the help of someone like CMC, re-evaluated the situation and overnight Prozac was changed from a neutral green and white capsule to a feminine Pink-and-purple capsule.It was then aggressively marketed with women being the target population.

In 2007 the FDA granted a licence for another Shire drug, namely Vyvanse. In 2008 it was approved for use in adults, in 2010 the FDA approved it to be used in adolescents.

So, what is Vyvanse indicated for?

In a nutshell, ADHD.

Back to the 'expert' paper "ADHD - Making the invisible visible"


Without looking into it's content we see that it is funded by Shire AG and supported by the European Brain Council.

I've wrote about the European Brain Council before.

In 2012 the European Brain Council  launched "The Year of the Brain". It's something that the EBC have been promoting for the past few years now, so much so that they are pushing for 2014 to be made the European Year of the Brain.

Here's their goals:

1. Increased public profile of all brain diseases in every member state
2. Increased access to education and information for patients
3. A measurable reduction in stigma
4. Raising the profile of good brain health and how to optimise brain health /prevent deterioration
5. Draw political attention to the costs and impact of brain diseases now and into the future
6. Increased research funding through the framework programmes and in the member states

And who is the Executive Director at the European Brain Council?

Step forward Mr Alistair Benbow, former European medical director at GlaxoSmithKline. Benbow was also Glaxo's Seroxat spokesperson back in the early 2000's. Seroxat, if you didn't know, is the UK brand name for paroxetine, better known as Paxil in the US and Canada and Aropax in Australia and New Zealand.


So, do we really need to open this 'expert paper' to read it's content or does the financial backing, medical writing and conflict of interest already tell us that it is going to be nothing more than a push to use more drugs on a condition that was invented by the pharmaceutical industry?

The paper is split into three chapters:

Chapter 1 provides information on the burden of ADHD on the individual, families and society.

Chapter 2 reports data from recent studies of ADHD, which further highlight the need for timely diagnosis and effective management approaches.

Chapter 3 outlines a number of policy considerations and recommendations for action with regard to raising informed awareness of ADHD, improving access to early and accurate diagnosis, improving access to treatment and care, involving and supporting patient organisations and encouraging a patient-centred research agenda.

I don't know about you but it's hardly going to be a cliffhanger, is it?

None the less, it's probably a great work of fiction.

You can download it here, if you so desire.






ADHD is a huge cash cow for the pharmaceutical industry. They have, over many years, carefully structured a marketing plan of which the first rule is to get the public to fear ADHD. A disorder becomes a disease because the word 'disease' has negative connotations.

ADHD - Making the invisible visible is just part of a huge jigsaw. When the jigsaw is complete it will have a hidden message, one that reminds me of the movie 'Contact' with Jodie Foster. Basically, Dr. Eleanor Arroway [Jodie Foster] works with SETI (Search for Extraterrestrial Intelligence Institute).

One day Arroway unexpectedly hears a powerful signal: a prime number pattern emanating from the star Vega, confirmed by others the world over, undeniable and strong in its pulsing power.

However, a video feed of Hitler is found mixed into the prime number pulse pattern. It is from the 1936 Olympics.

Look carefully into the whole ADHD promotion and you will see pretty much the same, a hidden message so famous that we have all started to accept it without questioning it.

Slice ADHD in half and you will see something not to dissimilar to what Arroway witnessed in Contact.

You just have to join the dots until eventually it hits you in the face.

"If you tell a lie big enough and keep repeating it, people will eventually come to believe it. The lie can be maintained only for such time as the State can shield the people from the political, economic and/or military consequences of the lie. It thus becomes vitally important for the State to use all of its powers to repress dissent, for the truth is the mortal enemy of the lie, and thus by extension, the truth is the greatest enemy of the State." - Joseph Goebbels, Reich Minister of Propaganda 

Question I'm asking here is quite simple, who is the modern day Goebbels, is it the medical writers, the key opinion leaders, Alistair Benbow or Shire?

Contrast all of the above with two recent news stories.

This one from the Irish Examiner, "Children prescribed ADHD medication unnecessarily, study claims", which highlights a 60% increase in the prescription of drugs for children with ADHD in the past six years.

...and this one that appeared on the CCHR website yesterday, With Nearly 5 Million U.S. Children on ADHD Drugs, Doctors Finally Express “Concern”, an article that states, "Recently published research in the British Medical Journal says doctors are concerned that children may be receiving an inappropriate diagnosis of ADHD."

So, you want to know who is telling the truth here?

Do what Dr. Eleanor Arroway [Jodie Foster] did.

Investigate it!







Bob Fiddaman




Monday, November 18, 2013

Sally K. Laden, The Paxil Ghostwriter Part III - Summation








"So Sally can wait, she knows it's too late as we're walking on by
Her soul slides away, But don't look back in anger, I heard you say."

"Don't Look Back In Anger" - Noel Gallagher



My summation is based upon two previous entries.

PART I

PART II




Raw data is like raw sewage. Dive into it and you'll be able to taste a lot of shit.

Fellow blogger and ex-psychiatrist, Mickey Nardo, who writes the 1boringoldman blog, hit the nail on the head a couple of days ago.

Nardo, like many others, has been writing about Study 329. He's dissected it bit by bit and thrown up some valid points. One such point, which really sums 329 up, came about after he read the depositions of both Sally K. Laden and Marty Keller.

"Neither the first author nor the ghost·writer looked at the actual data. I find that remarkable…", Nardo writes.

My  previous two posts highlighting Laden's deposition show that she was handed a summary of the clinical trial GlaxoSmithKline carried out in depressed kids. The actual clinical trial findings were bundled into a 1400 page document. Laden worked from just 200 pages that Glaxo gave her.

Keller, who was paid by Glaxo to add his name to Laden's work, had this to say when he was deposed:

"I've reviewed data analytic tables. I don’t recall how raw it was. Huge printouts. You know, that list items by item number. Item numbers and variable numbers. And don’t even have words on them. I tend not to look at those. I do better with words than I do with symbols."

Let's imagine for one minute that Laden and Keller are airline crash investigators and GlaxoSmithKline are an airline company. [GSK Airlines]

One of Glaxo's aircraft, Flight 666, goes down, killing all passengers on board. Laden and Keller are called upon to investigate the crash. The black box is found, it contains an hour of audio that is vital to the investigators but Glaxo, for some reason, deleted 40 minutes of that audio before handing it over to Laden and Keller.

Laden and Keller then work from the 20 minutes of audio that they have. As experienced investigators neither ask Glaxo if there is any more audio, they are happy to work from just 20 minutes of audio.

With the investigation complete Laden and Keller lay no blame on GSK Airlines, they blame pilot error.

Just before the press release GSK Airlines contact other experts in the field of aviation. They show them the findings of Laden and Keller and ask them if they would lend their names to the report. The following internationally respected air crash investigators add their support to the findings of Laden and Keller, like Laden and Keller none of them have had access to the original 60 minutes of audio from the black box.

Boris Birmaher, Gabrielle Carlson, Gregory Clarke, Graham Emslie, David Feinberg, Barbara Geller, Owen Hagino, Rachel Klein, Harold Koplewicz, Vivek Kusumakar, Stan Kutcher, James McCafferty, Rosemary Oakes, George Papatheodorou, Neil Ryan, William Sack, Michael Strober, Michael Sweeney, Karen Wagner, Elizabeth Weller and Nancy Winters.

This, for me at least, is the perfect analogy but there's a further twist...

Some years down the line GSK Airlines are sued by a passenger. John Doe slipped on an apple peel whilst walking to his seat on Glaxo's 747.

During the trial, John Doe v GSK Airlines, items of disclosure reveal secret emails between GSK Airlines, Keller and Laden that pertain to the crash investigation. Doe's law team have stumbled upon something that they weren't supposed to. They learn that GSK Airlines have covered-up the crash, they learn that the principle investigators, Laden and Keller worked from 20 minutes of audio and not 60. Further investigation shows that the missing 40 minutes of audio highlights what really happened aboard Flight 666. It was not pilot error, the airline company [GSK Airlines] were at fault. Ground control at GSK Airlines had put in the wrong flight coordinates causing Flight 666 to crash into a hillside killing all on board.

These findings are handed over to the Civil Aviation Authority who, after a 4 year investigation, find that GSK Airlines withheld vital information. However, the Civil Aviation Authority announce that no criminal charges will be brought against GSK Airlines, instead they send a letter to GSK Airlines CEO telling him that they are not happy with the cover-up/fraud [See GSK investigation concludes]

In one final twist, it is learned that the Civil Aviation Authority have two ex-employees of GSK Airlines on their board, one of whom, Ian Hudson, was a former airline safety expert during his time at GSK Airlines, he also worked very closely with overseeing the safety of Flight 666.

Perversely, and some years down the line, Ian Hudson accepts the role of CEO of the Civil Aviation Authority [See Former Glaxo Safety Officer Becomes Head of MHRA]


You smell corruption here?

There are a number of reasons why I chose, back in 2006, to create this blog. There are many more reasons why I continue to write.

You see, I was prescribed Paxil and I had a number of adverse reactions to it. I became addicted to it, I couldn't get off it, any attempt to do so was met with severe electric head zaps, feelings of aggression and, more importantly, one suicide attempt.

The more I dug, the more I learned.

A hat tip goes out to investigative journalist Evelyn Pringle. It was only through reading her work that I continued to push for answers from both GSK and the UK Medicines Regulator, the MHRA.

Another hat tip must go to BBC journalist Shelley Jofre. Four Panorama investigations into GSK, Paxil and the MHRA put fire in my belly.

Alison Bass, who wrote Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial, also deserves a lot of credit for highlighting the fraud behind Study 329.

There's also the work of David Healy, originally chastised by fellow psychiatrists for speaking out about the suicide link between kids and Paxil and other antidepressants.

Plaudits must go to John Jureidini and Leemon McHenry. Their tireless pursuit in trying to get Study 329 retracted from the Journal of the American Academy of Child and Adolescent Psychiatry should be met with a standing ovation.

The guys and gals over at Healthy Skepticism, who really started the ball rolling when they published 329 study documents online. A huge thanks should go to the team there.

The Citizen's Commission on Human Rights, have been banging the drum since God knows when regarding the suicide link and antidepressants, they too should take credit here.

Former US Senator Charles Grassley for giving GSK many headaches deserves, at the very least, an honourable mention as do the team at Baum, Hedlund, Aristei & Goldman, California's top ranked law firm who have spanked Glaxo and King & Spalding on numerous occasions.

There are many more who deserve credit, many of them bloggers...far too many to mention.



I walk alone across the outskirts of town
I can’t control what I’m going through now
Will you light the fire that I need to survive
Will you donate the life blood
Coursing through my veins
Will you open up the door & let me out of this place

"Strength" - The Alarm 1985




Further down the line I learned of the devastation Paxil had caused to families who were left to grieve the loss of their children, namely Sharise Gatchell and Sara Carlin, two young teens who both hanged themselves after being prescribed Paxil.

I have since met a number of families who have lost children and partners to a number of selective serotonin reuptake inhibitors [SSRIs] of which Paxil is one. As a parent I would just hate to utter those words, "my child killed himself/herself". It would be so hard for me to accept that one of my children had killed themselves, even harder to accept that they had suicided as a result of the drug they were taking. A pill that was meant to help them actually caused psychosis resulting in them killing themselves. The company/s that made the pills knew that this was a possibility but failed to warn because it would have affected their sales.

Death by hanging, death by jumping from a bridge, death by stabbing, death by overdose all because top pharmaceutical companies wanted to stay ahead of competitors.

It's the loss of life that carries me. It was so needless, particularly when we learn that these deaths could have been avoided if it wasn't for greed.

I am an extremely lucky person. My own experience at the hands of Paxil has, quite possibly, saved the lives of my three children. I was the guinea pig and I am thankful for experiencing Paxil induced suicide and the horrific withdrawal problems [addiction]. It was information that I was able to relay to my children. They, in turn, will relay the same information onto their children.

I'm lucky I can write about other people's kids killing themselves because I can always switch off and sleep at night, I don't have that overwhelming burden of grief to carry.

It's quite a position to be in. My heroes are not the academics, lawyers, journalists and human rights movement I listed above. My heroes are the parents of the dead children and partners. Neil and Rhonda Carlin, Steph Gatchell, Maria Bradshaw, Leonie Fennell and Tony Donnolly, Elaine Billings, Sara Bostock, Kim Witczak, Mathy Downing, Stuart and Claudette Jones, Celeste Steubing. And these are just the people I have met or corresponded with. My heroes are also those parents who lost their children because they were not warned about the risk of SSRI toxic poisoning during pregnancy. Christian and Matt Delahunty, Amery and Christiane Schultz, all of whom lost their babies to the antidepressant Effexor.

I've met many more in passing.

Each time I look at the list of my heroes I feel terrible sadness but a deep, underlying fighting spirit emerges from within. My sadness for their loss is insignificant. Why should I care about my own sadness when it is nothing compared to theirs? These parents and partners don't need my sympathy or empathy, they need answers as to why their children and partners were allowed to be given a drug that could induce their suicide and/or toxic poisoning. I want to embrace each and every one of them and somehow make their pain go away. I know that is an impossibility. Their loss will be with them forever, meantime I can sleep it off.

I will never be able to understand where they get their strength from to continue, they will probably tell me it's just a natural instinct to survive but as I sit here now and ponder... or at least try to ponder the unthinkable, I don't actually know if I could find the strength in me to survive after such a loss. All of the above have and continue to do so, each of them spreading awareness when it would have been so much more easier [and beneficial to the pharmaceutical companies] for them to accept death, deal with the rawness of the loss then try to move on in life as best as they could. For that they are heroes in my eyes. they are dealing with their own loss yet preventing, or trying to prevent the loss of others with the awareness they create. That's heroic by anyone's standards, it's a superhuman effort and they should each stand tall.

If I knew something was afoot about their deaths and did nothing about it then I, unlike the Paxil 329 Study authors, wouldn't be able to sleep at night.

If 329 was an airline crash study then the general public would, I'm sure, be outraged. At the very least there would be calls for a retraction of the findings from Laden, Keller et al. There would, I'm sure, be calls for the Civil Aviation Authority to be policed due to the blindingly obvious conflict of interest.

Alas, GSK are not an airline.

The MHRA are not an airline regulator.

Laden, Keller et al are not airline crash investigators.

They are all, in essence, part of a huge cover-up instigated by a British pharmaceutical company who sought profit before safety.

Sally Laden, Marty Keller, Boris Birmaher, Gabrielle Carlson, Gregory Clarke, Graham Emslie, David Feinberg, Barbara Geller, Owen Hagino, Rachel Klein, Harold Koplewicz, Vivek Kusumakar, Stan Kutcher, James McCafferty, Rosemary Oakes, George Papatheodorou, Neil Ryan, William Sack, Michael Strober, Michael Sweeney, Karen Wagner, Elizabeth Weller and Nancy Winters should all take a bow. They each have a responsibility to safeguard the public. Not one, to my knowledge, has called for Study 329 to be retracted. Not one, to my knowledge, has been angered enough to publicly chastise GlaxoSmithKline for duping them [if indeed they were duped]

All of the above should acknowledge that the study, initially drafted by Sally K. Laden, is misleading. By adding their names they have each persuaded a doctor to write a prescription for Paxil... for kids.

They should be utterly ashamed of themselves for duping fellow professionals and for putting kids in danger. They can each argue that they didn't know. Maybe so, but two points here.

1. They would have known if they would have asked for the full data

and

2. They know now but continue to defend their corners.


Finally, for now at least, there is one more twist in the tail.

The CEO of GlaxoSmithKline, Andrew Witty, was knighted back in 2012 for services to the economy and the UK pharmaceutical industry. For this he was given the title of 'Sir' and handed a medal from the Queen.

Witty has been asked, in a series of letters, to retract study 329 from the Journal of the American Academy of Child and Adolescent Psychiatry [see Witty's Era Still Smells of 329 Rotten Eggs]

Witty, via his spokespersons, does not agree that Study 329 was fraudulent and misleading.

Only John Grisham could come up with such a story.

I guess Witty has been instructed by Glaxo lawyers to never admit Study 329 is fraudulent. Deny, deny, deny is the rule of thumb here.

Glaxo's American lawyers, King & Spalding, who have defended Paxil on many occasions, have a Twitter account. If after reading Parts I, II & III of my Sally K. Laden series of posts you feel inclined to drop them a message then please feel free to do so. - @kslaw

They probably won't answer you but someone on their friend list may just get into debate with you. Glaxo, their lawyers and the likes of Sally K. Laden and Keller et al cringe at Study 329 debate, particularly when members of the public call for its retraction.

If, after reading this series of posts about Laden and 329 you feel compelled to share via Twitter and/or Facebook you, like me, will become frustrated at the lack of response from those on your friend lists who take little interest in antidepressants and suicide. I call these the 'fluffy  bunny brigade', although they are good people and great friends they much prefer not to involve themselves in your world of grief. A photograph of a fluffy bunny, cute kitten or puppy would get more responses if you were to post it on Twitter or Facebook.

These are the people that need educating because they too need to warn their children and their children's children that there's a bunch of adults who ghostwrite and add their names to published studies who really have no interest whether children or grandchildren live or die. We have, in GlaxoSmithKline, a company who have kept social media acquaintances in the dark about the safety of Paxil in children and adolescents, a company who refuse to retract 329.

I'll always strive to do my bit.

The rest is up to you.


Bob Fiddaman



Sally K. Laden's deposition can be downloaded here.







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