Masterfully Harming Kids for Profit

eu·phe·mism (noun)

1. the substitution of a mild, indirect, or vague expression for one thought to be offensive, harsh, or blunt.

"Part of my job is to create ‘masterful’ euphemisms to protect Medical and Marketing." -- Guess Who?

If you think the above quote is from a sleazy character in the hit TV series Mad Men, you'd be partly right. It is indeed uttered by a sleazy character, but in this case, it's a real person, a mad woman named Amy Rubin. When you learn what Rubin did, you'll understand why this woman can't accurately be called a lady.

As a Regulatory Affairs Manager for Forest Pharmaceuticals, Rubin proudly used her marketing skills to help pull the wool over the FDA's eyes regarding Forest's dangerous, ineffective drug, Celexa, which carries the generic name of citalopram. Rubin made her self-aggrandizing declaration in a memo sent to Dr. Charles Flicker, Senior Medical Director of Forest Laboratories as the two concocted ways to stretch the truth so that more doctors would prescribe Celexa for children and adolescents.

Spin Doctors At Work

Forest Pharmaceuticals conducted the MD-18 study involving Celexa, an SSRI now owned by Allergen. MD-18 was supposed to be a double-blind, placebo-controlled clinical trial of pediatrics. According to unsealed documents and testimony, MD-18 was only able to achieve a positive result by including nine patients in the study that were, as Forest’s medical director stated, “automatically unblinded” due to a supposed dispensing error. (Blinded means that a study's investigators are not supposed to know who consumed the product and who consumed the placebo.) The MD-18 investigators did know who was consuming Celexa and who was consuming placebo. And Forest Pharmaceutical execs knew this, too. The MD-18 study was flawed and biased.

The company then whitewashed the data in a draft letter to the FDA stating that incorrectly dispensed pills could have “potentially unblinded the study,” - After the draft was passed around Forest Labs they decided to rephrase the term and acknowledged that the wrongly dispensed pills could have the  “potential to cause bias.” By omitting the word 'unblinded' Forest was deliberately trying to hoodwink the FDA and create the false impression of positive results.

Forest then actively promoted the MD-18 study to encourage doctors to prescribe Celexa for children. The company later used the flawed MD-18 study to gain FDA approval for its other SSRI, Lexapro (escitalopram) and promoted it for adolescents. The result: Forest made money peddling snake oil to doctors knowing that unsuspecting parents would likely later make funeral plans for their children.

Last month Los Angles law firm, Baum, Hedlund, Aristei & Goldman, wrote a letter to Greg Shapiro, Chief of the Affirmative Civil Enforcement Unit, regarding a series of agreements that Forest made in 2010 with the United States Attorney’s Office for the District of Massachusetts. (USAO). Baum Hedlund points out that the 2010 settlement agreement missed some crucial evidence.

Baum Hedlund states:

"Over the past several years, our litigation has revealed that the scope and extent of Forest’s fraud was not honestly disclosed to the USAO (or, to the Food and Drug Administration) and that Forest misrepresented material facts underlying the USAO’s prosecution.  Documents and testimony obtained in our litigation have been unsealed, over Forest’s objection, and we have prepared a detailed memorandum outlining Forest’s misconduct and fraud with the hope the USAO will consider reopening its investigation."

The unsealed correspondence between Rubin and Flicker shows how pharmaceutical companies intentionally and routinely put the public--including children and teens--at great risk of harm and death from their products.

Wreckless Endangerment of Children

I tried to find a photo of Amy Rubin to show you what an evil spin doctor looks like, but it seems Rubin is camera shy. For her role in creating a medical holocaust that harms and/or kills thousands of innocent children, I've chosen a makhsheyfe or Baba Yaga photo to represent Rubin. If today Rubin is a mother, I imagine the reckless endangerment she helped unleash in neighborhoods across the globe isn't something she'd want to do to her children or grandchildren. But harming children is merely business as usual for Amy Rubin and her pharma colleagues.

So, as Forest's Rubin once wrote that it was part of her job to "create ‘masterful’ euphemisms to protect Medical and Marketing", it's part of my job to protect children and adolescents.

I hope Amy Joyce Rubin, age 64, has no contact with the innocent children in her Paterson, New Jersey neighborhood.

There are many appropriate adjectives we could use to describe Rubin, most of which are four-letter words. I'll leave it to you to fill in the blanks.

Bob Fiddaman

Baum Hedlund's letter to the Chief of the Affirmative Civil Enforcement Unit can be read here.

Court Documents Show Celexa in Bad Light for Kids

The above meme is applicable to doctors and patients alike. The 'open your mouth' line fits perfectly for both. Doctors should know all the facts before they recommend a treatment to a patient, a patient should know all the facts about the said treatment before they open their mouths to ingest it.

Which brings me nicely to a study recently published regarding a clinical trial involving a widely prescribed antidepressant. Citalopram, known better by its brand names of Celexa in the US and Cipramil in the UK.

Citalopram was tested in kids between 1999 and 2002 and was known as CIT-MD-18 pediatric depression trial. The results and subsequent publication of those results were, as we've come to expect, ghostwritten by PR company Weber Shandwick, more specifically it was ghostwritten by Natasha Mitchner at Weber Shandwick Communications, under instruction from Jeffrey Lawrence (Product Manager Forest Marketing)

For those who don't know, Forest Labs are the American pharmaceutical company that market Celexa. Forest Labs are a subsidiary of Forest Pharmaceuticals.

“A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents,” was published in the American Journal of Psychiatry in June 2004. However, its lead author wasn't neither Mitchner or Lawrence.

Some 10 years after publication a lawsuit against Forest was, in part, settled. The lawsuit, Celexa and Lexapro Marketing and Sales Practices Litigation, had during its intensive investigation, found the confidential documents relating to CIT-MD-18, 750 of which, have now been made public on the on the Drug Industry Document Archive (DIDA) website. In all, over 63,000 documents were handed over to plaintiff lawyers who were suing Forest Labs for the safety and efficacy of Celexa and Lexapro (US trade names for citalopram and escitalopram respectively) in marketing the drugs “off-label” for pediatric use.

The 750 public documents have been desconstructed by Jon N. Jureidini, Jay D. Amsterdam, and Leemon B. McHenry and the results are startling, to say the least.

"The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance" shows, amongst other things, that;

CIT-MD-18...

• Contained efficacy and safety data inconsistent with the protocol criteria.
• Procedural deviations went unreported.
• Negative secondary outcomes were not reported.
• Adverse events were misleadingly analysed.
• Manuscript drafts were prepared by company employees and outside ghostwriters with academic researchers solicited as ‘authors’.
• Authors failed to mention that the five citalopram-treated subjects discontinuing treatment did so due to one case of hypomania, two of agitation, and one of akathisia, none of these conditions were found in the placebo group.

The deconstruction of the 750 documents also showed the authors that protocol-specified outcome measures showed no statistically significant difference between citalopram and placebo. In other words, children taking citalopram found it as effective as taking a sugar-coated pill.

This is contrary to the 2004 study published in the American Journal of Psychiatry in June 2004 where it was stated that, "In this population of children and adolescents, treatment with citalopram reduced depressive symptoms to a significantly greater extent than placebo treatment and was well tolerated."

Fig 1

The 2004 study shows that its lead author was Karen Dineen Wagner (Fig 1) but as the deconstruction study shows Wagner merely added her name to the study (as lead author) that was penned by Natasha Mitchner at Weber Shandwick Communications.

Wagner is no stranger to controversy, she'd previously added her name to the Paxil 329 ghostwritten paper without actually looking at the raw data [which showed an increased rate of suicidal thoughts in kids taking Paxil]. It's also been learned through various litigation in the US that Wagner was paid to deliver lectures promoting the use of Paxil for depressed kids and teens to both GSK’s sales reps and doctors, this despite ever taking a look at the raw data of 329. Maybe she had faith in the ghostwriter of Paxil 329, Sally K. Laden, just as she did with the Celexa ghostwriter Natasha Mitchner ~ Who knows what makes Wagner tick?

In the complaint filed against Forest Labs it was alleged that the American pharmaceutical company arranged for Karen Wagner to give promotional presentations on the pediatric use of Celexa and to serve as the chair of a seven-city Continuing Medical Education ("CME") program on treating pediatric depression... even though the CIT-MD-18 trial was a failure.

So, to recap...

• Forest conduct clinical trials then write up the results of that trial via a ghostwriter.
• Once the study result are written, Forest hire well known pediatric psychiatrists to claim the the ghostwritten work is theirs.
• Despite Celexa showing no efficacy over placebo, the study (now allegedly written by Karen D. Wagner) shows that it "reduced depressive symptoms to a significantly greater extent than placebo."
• Forest Labs are denied a licence to sell Celexa for child depression but, none the less, send out reps to promote it's safety to prescribing physicians, who were often "dined and dashed" in efforts to get them to prescribe Celexa, the drug that was shown not to work in kids, to kids.

Oh, I forgot to mention, the kids targeted by Forest, Wagner et al were age 7 to 17.

Jon N. Jureidini, Jay D. Amsterdam, and Leemon B. McHenry conclude their findings with...

"It is important to make these articles transparent to correct the scientific record. It is furthermore imperative to inform the medical community of mischaracterized data that could lead to potential harm to children and adolescents who are vulnerable to the effects of medication on the growing brain and may increase suicidal thinking and behaviour."

I couldn't agree more.

Jureidini, Amsterdam, and McHenry ~ take a bow. I salute you all.

Drs. Amsterdam and Jureidini were engaged by Baum, Hedlund, Aristei & Goldman as experts in the Celexa and Lexapro Marketing and Sales Practices Litigation. 

Dr. McHenry was also engaged as a research consultant in the case. Dr. McHenry is a research consultant for Baum, Hedlund, Aristei & Goldman.

"The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance" appears in the International Journal of Risk & Safety in Medicine, vol. 28, no. 1, pp. 33-43, 2016

Fiddy Rant.

So, here we see yet another pharmaceutical company hiring the ghost writing services of a PR firm. Yet another pharmaceutical company who make claims that a drug is safe and effective when it isn't. Once again we see prominent psychiatrists adding their names to published papers when their input to these published papers is minimal to say the least. Furthermore, and yet again, we see a pharmaceutical company promote the use of a non-efficacious drug by wining and dining health care professionals.

Citalopram is from a group of medicines known as Selective Serotonin Reuptake Inhibitors (SSRIS). It has been well documented that Citalopram can induce thoughts of suicide and homicide in many numbers of people that take it. Why then, did Forest Labs spin the data on the CIT-MD-18 pediatric depression trial? Why did Karen Wagner et al claim to have written the study when court documents show that it was written by someone else?

Moreover, what is it with pharmaceutical companies and top paediatric psychiatrists and their apparent lack of care for the safety of 7-to 17 year-olds?

Criminal charges need to be brought against those who played a part in the manipulation of this study. That goes for the top executives at Forest Labs, the reps who promoted its use in kids and the top psychiatrists who put their names to support the data (without actually looking at the data). Charges too should be brought against any doctor who received a bribe from Forest Lab reps, be that a free dinner of tickets to the baseball game.

Off-label prescribing of antidepressants to kids is wrong. I know there are some that disagree with me but look at the facts now. Study 329 (Paxil didn't work in kids) - CIT-MD-18 (Celexa didn't work in kids) ~ So, why prescribe something that doesn't work? 

The side effects of Celexa are pretty horrific for adults let alone children ~ don't even get me started on they harm the can cause to fetuses!

The evidence in these two recent cases now show that neither Paxil or Celexa is beneficial to children yet in 2016 both drugs are still prescribed to children. The heavy illegal promotion undertaken by GlaxoSmithKline and Forest Labs reps still works to this day.

Shit doesn't just stink, it sticks.

Over to you, DOJ.

Bob Fiddaman.

Related

The jewel in the crown ~ Mikey Nardo

The Shane Clancy Case: Celexa Induced Homicide/Suicide

Citalopram Birth Defects (Guest Post)

GUEST POST - The Lundbeck Runaround

The following is a guest post from Cheryl Buchanan. Cheryl has previously written a guest post on this blog [link at bottom] - this is an update regarding her mission to seek the truth from Lundbeck, a Danish pharmaceutical company who manufacture the antidepressant citalopram, known by its brand name of Cipramil and known in the US as Celexa.

It's worthy to note that both citalopram and its sister drug, escitalopram, are both the subject of litigation in the United States. For further information please visit Forest Illegally Promoting Antidepressants for Kids!


GUEST POST - The Lundbeck Runaround

Back in December Bob Fiddaman very kindly invited me to write a guest post for his blob. I had contacted him after finding his blog while scouring the Internet for information about anti depressants and birth defects. I had just discovered that before, and during, the time of my first pregnancy in 2004 I had been prescribed the SSRI antidepressant citalopram. My daughter was born at 23 weeks gestation, she had multiple abnormalities and was incompatible with life.

Upon speaking to Bob I sadly discovered I was not alone and that there have been many women whose children developed birth defects in pregnancy while their mothers were taking citalopram and other SSRIs.

At the time I was assured it was safe and was wholeheartedly encouraged to keep taking it. I was on a very high dose (60mg) which is no longer prescribed as its known to cause long QT syndrome in adults.

It has now also been proven that it can cause birth defects, especially those related to the heart and abdominal wall. My daughter had no diaphragm and other abnormalities, all of the details are included in my previous guest post 

I have been in contact with Lundbeck to ask them a series of questions, in the beginning they were more that happy to accommodate, every email was replied to promptly. That was until the chat I had with Bob where we decided it was a good idea to copy Bob in on all the correspondence between myself and Lundbeck. It appears Lundbeck did not like this.

The first email I sent, with Bob cc'd, went unanswered. I waited a good few weeks but still nothing, I gave them the benefit of doubt and emailed again just in case they hadn't received it but yet again, no reply. Bob also told me that he had noticed an IP address he did not recognize had visited his blog, he decided to trace the IP and yep, you've guessed, it was Lundbeck in Copenhagen. By now I was getting majorly pissed. I decided to call Lundbeck and ask why they hadn't answered. This is the conversation that followed.

Conversation with Lundbeck employee 1.30pm 22/07/14

(CB - me, LU - Lundbeck)

CB - Hi can I speak to Ms Warrilow please?

LU - I'm sorry but she is not in today, it is anything I could help you with?

CB - Maybe you could but I'll have to explain the situation I'm in first.

LU - OK, go ahead.

CB - Back in 2004 I had a baby who developed severe abnormalities, she was incompatible with life and passed away at 23 weeks gestation. I was prescribed Citalopram at a dose of 60mg prior to, and during pregnancy. My GP knew I was trying to conceive and prescribed folic acid to me.

I was also told by more than one GP at my surgery that SSRI antidepressants were safe. I have a fair feeling citalopram caused my daughters birth defects. I had been in correspondence with Ms Warrilow who was answering some questions I had. We were in contact for several weeks but I have not had a reply to the last email I sent with a question, this was in December, or any subsequent emails asking why I was not being replied to.

LU - Oh, that's strange, maybe the question you had didn't have an answer. Why do you seem to think citalopram caused the birth defects, that's not a question there is an answer to, that's like asking if the sky is blue.

CB - I want to know because I am her mother and at the time no cause was found for her problems, she had normal chromosomes. I know from researching that SSRI's can cause birth defects.

LU - We recommend that the patient speaks to their GP, that is our guidance.

CB - I am way beyond "Speaking to my GP", I have had a meeting with the Clinical Director of the maternity hospital my daughter was born in, its in my records that he sent a yellow card warning to the Centre for Adverse Reactions in Scotland about the adverse reaction to Citalopram.

LU - When was this again, 2004, Oh I don't know if you will get any information, it was a long time ago.

CB - I have contacted the MHRA as my consultant contacted them. I wanted to ask if they had any information.

LU - The MHRA won't have any information, all reports are anonymous. I don't understand why you want to know, there is nothing that can give you a definitive yes or no.

CB - Would I be better contacting Lundbeck in Denmark directly? Or is there someone else I could speak to?

LU - Why would you want to do that, Eve already told you, we recommend you go back and see your GP.

CB - So all of this is my GP's fault for prescribing it?

LU - We tell the GP's to read the PIL, and the information we give them, and make their recommendations from that.

CB - But did the PIL or your information for GP's state the risk of birth defects in babies back in 2004?

LU - Oh we never recommend prescribing antidepressants in pregnancy, no studies have been done.

CB - There are other SSRI's, paroxetine being one, which is known to cause birth defects, I know citalopram is a category C, paroxetine is D.

LU - Oh, but we still do not recommend it in pregnancy.

CB - When will Ms Warrilow  be back?

LU - Tomorrow, what is your name and I will get her to contact you?

CB - Cheryl Buchanan, I have emailed a couple of times and had no reply.

LU - It must be the spam filter, we have been very busy and maybe just haven't gotten to your emails.

CB - It is possible its because I have copied Mr. Bob Fiddaman in on the correspondence? He has been giving me help and advice and has a lot of knowledge about SSRI's. He also has a blog and told me his blog has been visited a number of times by an IP he did not recognize, after checking it he found it belongs  to Lundbeck in Denmark so I think that you have been receiving my emails.

LU - I don't know anything about it. I will have Ms Warrilow contact you. Are you still taking Citalopram?

CB - No.

LU - Are you on a different SSRI?

CB - Yes but I am withdrawing from using it as I will not be a hypocrite and take something which more than likely killed my daughter.

LU - Are you doing this under GP's guidance.

CB - Yes. Thanks you for your time. Goodbye.

LU - No problem, bye.

I was dumbfounded. I awaited a response but once again was ignored. So I waited some more, just long enough for them to think I had gone away.

Then I called their head office again, this time the person who answered the phone was the one who I'd been speaking with by email.

Conversation with Ms W (Lundbeck) 17/02/14 - 4.30pm

CB - Hi can I speak to Ms Warrilow please?

LU - This is her speaking...

C - Hi, I am not sure if you know who I am but my name is Cheryl Buchanan, I was speaking to you through email a couple of months ago, about my daughters birth defects?

LU - Yes, I do remember

CB - I sent you an email back in December and I never got a response, I have since then emailed you several times and never got a reply.

LU - Oh, er, I think that was because there wasn't really anything else we could say to you.

CB - I understand that but it would have been more courteous if you could have replied telling me that, this situation is consuming my life at the moment and having to send repeated emails, with no answer, it doesn't help.

LU - Oh, yes, I do apologize.

CB - I actually called a couple of weeks ago and spoke to a colleague of yours, she took my details and assured me she would have you contact me.

LU - Oh, erm...

CB - I hope you understand I'm not blaming you personally, I know its absolutely nothing to do with you but a reply would have been helpful, even if to say you didn't have anything else to tell me.

LU - (Silence)

LU - The MHRA have been in touch with us, you asked in your email if they contacted us in 04, they didn't but have since, they might be able to help you. Would you like a copy of the information they sent us? It is anonymous but we figured it was you.

CB - I filled in another yellow card a couple of months ago and asked for them to contact me, I never got a reply, I imagine they have contacted you about the Yellow card I sent recently. If you could send me a copy of what they sent you I would really appreciate it.

LU - OK, that's not a problem.

CB - Can I ask a question? Do you know what the PIL stated about prescribing citalopram in pregnancy back in 2004, or could you find out? What I'm trying to figure out is if GP's would have known citalopram was a teratogen back then?

LU - I can get a copy of it, I'm sure it said use with caution but I can find out for you and send a copy of the 04 PIL to you.

CB - Do you know when the risks of prescribing in pregnancy were was added to the PIL, was it 2004?

LU - I'm not sure, the PIL changes all the time.

CB - I'm trying to figure out if GP's would have known Citalopram was a teratogen.

LU - I can get you a copy of the GP information and send it to you? I'm sure it would have said use with caution in pregnancy.

CB - That would be great

LU - Do we have your address, I don't think we do?

CB - No you wouldn't have, all our conversations were by email. (I give her my address)

LU - I will get that sent to you tomorrow, do you remember us sending you a permission form for you to sign so we can contact your GP?

CB - Yes but I don't have a printer so can't return it, could you send me a paper copy please?

LU - Of course, Ill get it send out to you along with the other information.

CB - Thank you for your time, bye.

LU - Bye.

While I had been awaiting a reply I decided to complain to the MHRA about Lundbeck's lack of response, just today they sent me a reply which seems to have been written by a robot and in no way at all answers the complaint I put to them.

Dear Ms Buchanan,

Thank you for your email regarding the lack of response from Lundbeck and your concerns regarding the product Citalopram. We are very sorry to hear about what has happened to you and your daughter.

Your email was treated as a patient report and we were as a consequence able to link this up with your previous correspondence with the Vigilance and Risk Management of Medicines Division.

In relation to Lundbeck your information has been passed to the Inspection, Enforcement and Standards Division who have responsibility for conducting Pharmacovigilance inspections of Marketing Authorization Holders (MAHs) such as Lundbeck. This information will be entered into the risk information system; this system is used to determine how often organizations are inspected. At such inspections we check how the MAH handles reports such as your own as they have responsibility for the on-going safety of products on the market. During any such inspection we do of course preserve the identity of any individuals such as yourself.

Once again, thank you for alerting us to this potential adverse reaction and the actions of the company.

Kind Regards,

Customer Services External Relations Medicines and Healthcare Products Regulatory Agency

Right now I am furious. This morning on my daily hunt of the net for info I was on Lundbeck's LinkedIn page. In the careers section their is a large photo header with the statement "Everyone deserves quality of life". How completley and utterly hypocritical. What about my daughters "quality of life"?

Because of a medication, made by them, which they knew in studies killed of the fetuses of pregnant rats and they marketed as being safe in pregnancy, my daughter is dead. She never got a chance of life. So Lundbeck, if you are reading this, please know that I'm not going to go away. I will keep doing my utmost to prove your are responsible for my child's and hundreds, possibly thousands, of other children's birth defects.

I have had several women come to me in the past few of weeks to tell me their story and how their children were born with birth defects after taking SSRI medication. I am not only doing this for my child, but for all the children whose lives have been damaged by your drugs.

To Bob Fiddaman, thank you from the bottom of my heart.


Back Stories

Citalopram Birth Defects (Guest Post)

The Lundbeck Emails [Citalopram Birth Defects]

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.

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.

Patient Information or Litigation Disclaimer?

I was browsing through some SSRi patient information leaflets [PILs] earlier and have come to the conclusion that the manufacturers warnings about this, that and the other are merely coded messages to the consumer.

Years ago, when SSRi's first hit the market, there were few warnings of side-effects. Sure, back then we had dizziness, nausea, sweating etc but that's standard for most, if not all, prescription medicines.

Today, after US litigation, patient reporting and, it has to be said, internet activism, the PILs take on a completely different look. They [the manufacturer] are telling us we can't sue because we were told.

It's almost as if pharmaceutical compliance departments had a eureka moment and turned really bad news into something that could be productive in the future. "Hey if we stick broad but vague warning labels on our drugs then we cover ourselves from future litigation... quick, get the number for that medical ghostwriting team we used back in 1998"

Let's take a look at Seroxat for example. [NHS Information]




Motion to dismiss

1. Some people who take Seroxat may find that it intensifies depression and suicidal feelings in the early stages of treatment. 

Very vague statement but one that would certainly be used by GlaxoSmithKline attorneys if they were ever faced with a lawsuit. "There is no case for your client as my client clearly stated in the patient information leaflet that Seroxat wasn't for everyone."

2. "If you are taking Seroxat, or you care for someone who is taking Seroxat, you need to look out for changes in behaviour that could be linked to self-harm or suicide.

"If you notice any of these changes or are worried about how Seroxat is affecting you or someone you care for, you should contact your prescriber, a mental health professional or NHS Direct as soon as possible."

Again, Glaxo attorneys could have a field day, "Your honour, we have reason to believe that the deceased did not contact their prescriber, yet my client clearly stated in the patient information leaflet for them to do so if they were feeling suicidal, therefore we argue that there is no merit in this case" 

 3. Seroxat is not suitable for everyone and some people should never use it.

"Your honour, if the deceased had killed themselves by touching an electrical fence despite there being a warning not to do so would my learned friends still be representing him in court?" 

4. Over time it is possible that Seroxat can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Seroxat has become unsuitable, it is important that the prescriber is contacted immediately.

"Your honour, the plaintiff may have become, over time, unsuitable for our client's product, he may also have had an adverse reaction to my client's product. At no time, leading up to his attempted suicide, did he contact his prescriber despite the fact that my client had advised this in the patient information leaflet."

5. You should only take this medicine during pregnancy if your doctor thinks that you need it

"Your honour, whilst my client has every sympathy for the birth defects the child in this case was born with, it was not my client's fault. My client never prescribed Seroxat to this young mother, it was her doctor."

6. If you take this medicine during the late stages of pregnancy your baby may have some problems after birth

"Your honour, how many warnings did this mother need, was she illiterate, could she not read? My client refutes any responsibly with regard to the plaintiff's son being born with septal heart defects. In fact, my client believes that it should be the plaintiff who should be facing prosecution for acting irresponsibly."

 7. This medicine may decrease fertility in men.

"Your honour, he was warned."

8. Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife.

"Your honour, my client blames the plaintiff and both the doctor and midwife, they should have read the patient information leaflet."


Judge's summation - Sadly, it is with great regret that I am granting GlaxoSmithKline motion to dismiss on the grounds that they covered all bases for any future litigation by applying warnings to their patient information leaflet. I am, however, recommending that in future Glaxo elaborate on the warnings. My recommendations are underlined:


1. Some people, particularly those who are poor metabolizers, who take Seroxat may find that it intensifies depression and suicidal feelings in the early stages of treatment. GlaxoSmithKline nor your prescriber cannot tell you if you are a poor metabolizer so, in essence, by administering Seroxat you are playing solo Russian roulette.

2. If you are taking Seroxat, or you care for someone who is taking Seroxat, you need to look out for changes in behaviour that could be linked to self-harm or suicide. Changes such as an increase in depression, anxiety, an inability to sit still, a lack of empathy toward others, excruciating electric-like zaps in your head, horrific nightmares where the subject matter is death, homicide, suicide. Outbursts of anger, for no apparent reason, aimed at those you love. If you notice any of these changes or are worried about how Seroxat is affecting you or someone you care for, you should contact your prescriber, a mental health professional or NHS Direct as soon as possible. NHS Direct et al should then telephone a 24 hour hotline, manned by an independent body who have no financial ties to GlaxoSmithKline, and request a safe withdrawal protocol. The patient should be hospitalized, at GlaxoSmithKline's expense, and monitored at regular intervals. Any item of clothing that could be used as an instrument for suicide must also be removed. GlaxoSmithKline's CEO, Sir Andrew Witty, should be contacted, no matter what time of day or night it is. Sir Witty may then realise that bad things didn't just happen to patients under JP Garnier's watch, they are still happening and are not part of "an era". Sir Witty can sit with the patient while he/she experiences thoughts of self-harm and/or suicide. Because of the logistics and vast number of people who suffer these kind of adverse reactions to Seroxat it is recommended that Sir Witty handpicks a team of GlaxoSmithKline executives to be on emergency call to tend to the needs of Seroxat induced suicide victims.


3. Seroxat is not suitable for everyone and some people should never use it. Some people cannot excrete Seroxat from their system quicker than others. This means that they build up toxic levels of the drug, in fact these people are overdosing on Seroxat without actually knowing it. This simple fact should be made crystal clear in future patient information leaflets. Sir Witty and his handpicked team of executives should disseminate this information to the public by word of mouth. Alternatively  a full page advertisement can be used in popular mainstream newspapers to warn this vulnerable patient population. "Toxic levels of Seroxat may lead to self harm and suicidal thoughts" should also be added to the patient information leaflet.


4. Over time it is possible that Seroxat can become unsuitable for some people, particularly those who are poor metabolizers, or they may become unsuitable for it, particularly those who are poor metabolizers, If at any time it appears that Seroxat has become unsuitable, it is important that the prescriber is contacted immediately. The Prescriber should then contact GlaxoSmithKline to file an adverse reaction report. In turn GlaxoSmithKline should investigate the adverse reaction and report back to the prescriber with a causality assessment. This will then help the prescriber decide, in future consultations with patients, if Seroxat is the drug for them.

5. You should only take this medicine during pregnancy if your doctor thinks that you need it - This whole sentence needs drastic change. A doctor does not have access to the rat pup studies that GlaxoSmithKline has and kept from the public. Expectant mothers should be made aware of the Sloot study whereby Seroxat and other SSRi's were exposed to rat fetuses. Out of all the SSRi's used in this study only one came out as a clear teratogen - Seroxat. Another example of a teratogen, in case consumers are not aware of the word, is the anti-nausea and sedative drug, Thalidomide.

6. If you take this medicine during the late stages of pregnancy your baby may have some problems after birth. The sort of 'problems' are:


Persistent Pulmonary Hypertension of the Newborn (PPHN) – 6 times increased risk
Anencephaly (fatal neural tube defect) – 2.5 times increased risk
Clubfoot – 5 times increased risk
Craniosynostosis (craniofacial defect) – 2.5 times increased risk
Omphalocele (abdominal wall defect) – nearly tripled risk
Gastroschisis (abdominal wall defect) – 30 percent increased risk
Pulmonary Atresia – 3 times increased risk
Spina Bifida – 60 percent increased risk
Diaphragmatic Hernia – 80 percent increased risk
Anal and Esophagal Atresia – 30 percent increased risk
Heart Defects – nearly doubled risk
Septal Defects, including Atrial and Ventricular (also known as “hole in the heart” defects)
Hypoplastic Left/Right Heart Syndromes
Malformed or blocked heart valves that will not close
Transposition of the Great Arteries
Tetralogy of Fallot
Mitral Valve
Heart murmur

Like packets of cigarettes I make the recommendation that GlaxoSmithKline add a photograph to the packaging of Seroxat. An example is below.

Spina Bifida – 60 percent increased risk when taking Seroxat [1]

7. This medicine may decrease fertility in men. Given recommendation 6 this may not be such a bad thing, particularly if the female partner is also digesting Seroxat. Sir Witty and his team of handpicked executives may wish to visit any male patient who has decreased fertility as a result of taking Seroxat and, if requested, help to fill out some adoption forms for the wannabe father. GlaxoSmithKline shall foot the bill for the whole adoption procedure, including lawyers fees and expenses for the child up to the age of 19.

8. Before you have your baby you should discuss breast-feeding with your doctor or midwife as Seroxat can find a way into your baby when he/she breast feeds. This can cause serious implications for the newborn child and may result in Seroxat overdose, addiction, agitation and in some instances death. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. They will also offer you the court transcripts from the Kilker Vs GlaxoSmithKline birth defect trial where GlaxoSmithKline were found guilty for manufacturing a drug [Seroxat] that caused Lyam Kilker to be born with heart defects. This will  help expectant mothers to make a fully informed decision and may deter them from breast feeding given that Seroxat can harm a baby whilst it is still in the womb so chances are the baby can be harmed if ingesting breast milk that is still in the mother's system. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife and with the knowledge that your doctor or midwife actually know what they are talking about.


I make these recommendations with the knowledge that healthcare professionals and GlaxoSmithKline have the right to ignore them as do global medicine regulators and coroners. In fact, the word 'recommendation' means nothing. It just makes people like me seem as if I really care when in actual fact I'm just recommending what I think should be done but I know that the likelihood of any recommendations made simply means that nothing has to be adhered to. I'm a Judge and I have to be seen to be doing something. I use war as an example. World leaders got together to fight the might of Hitler. At some point it was only recommended that they intervene. They didn't have to but because they did they stopped Hitler, some would suggest that those recommendations to intervene should have been carried out earlier, maybe more lives would have been saved. Thing is, those recommendations were listened to, they were put into place and we are a better world for it.

I would urge for GlaxoSmithKline's CEO and handpicked executives to search their consciences but past litigation [in the US] has shown that these individuals blame everyone and everything but their product.

I would like to recommend that Seroxat is removed from the shelves but know I would face tough opposition from those who have been duped into believing that the benefits of this particular antidepressant outweigh the risks. The risks, all of them, should be printed out in clear laypersons terms, again, I can only recommend this. I do know that, after reviewing all the court documents in cases such as Seroxat induced suicide, Seroxat birth defects, Seroxat withdrawal/addiction, that I will never allow any family member of mine to take this drug. That's my privilege as I am a Judge.

Glaxo's motion to dismiss - Granted.

Rt Hon Judge I.M Pointless


**Footnote**

Later that year the Rt Hon Judge I.M Pointless granted the same motions to Eli Lilly, Wyeth, Pfizer, Forest Labs, Lundbeck and other SSRi manufacturers, including those manufacturers that make generic versions of SSRi medication. 

He also made similar recommendations.


[1] Birth Defects Cased By Seroxat [Birth Defect Resource]




Bob Fiddaman

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Celexa/Lexapro... Or Your Money Back

Not for use in children and adolescents

Celexa [citalopram] and Lexapro [escitalopram] are two antidepressants in the family of SSRi's. Some would argue [I'm one of them] that both antidepressants are pretty much the same. Let's face it, Lexapro only ever came to market because the patent was running out on Celexa.

Forest Labs, the manufacturer, have argued that the two drugs differ, maybe so but the end result is the same particularly when it's been down to the marketing team of Forest Labs.

Once again, kids have been targeted despite these group of drugs bearing warnings that they were not recommended for pediatrics.

How do we know this for sure?




Well, in 2010 Forest Labs settled with the US government. Forest Labs were accused of illegally promoting Celexa for use in children and adolescents despite the fact it had not been approved for marketing in the United States.

In other words, they were promoting the use of Celexa in kids to doctors through "off-label" marketing.

We know how that works, right?

Kickbacks, holding back negative study results, ghostwritten papers, in general bending the law to suit their needs.

Forest Pharmaceuticals, a subsidiary of Forest Labs, also pled guilty to a whole range of underhand practices including misbranding Celexa by marketing it for use in children from 1998 to 2002.

With these two settlements Forest Labs and Forest Pharmaceuticals have paid out a wad of cash, moved on and now, it seems, it's business as usual.

But there's one final twist in the Forest saga.

Both Forest Labs and Forest Pharmaceuticals, because of their illegal promotion, now may have to reimburse the families of those who paid for prescriptions of Celexa and Lexapro. Rightly so too.

A consumer fraud class action is underway, meaning that if you as a parent of a child who took Celexa or Lexapro can claw back what you paid. Quite a hefty amount if your child was on either drug for a long time.

These types of consumer fraud cases need a lead plaintiff, someone that not only represents their child or children but one who represents the whole class action. It's like a lead case. Classic example here being the Kilker V GlaxoSmithKline case. Lyam Kilker was born with heart defects as were 800 other kids. Kilker et al represented the class action, they won the case against Glaxo which meant Glaxo settled the majority of other cases.

The Forest lawsuit is looking for additional class representatives. There are already some lead cases in places for many of the US states but more are needed. I'm pretty sure those that represent a group action are compensated handsomely, and why not - putting yourself out front deserves to be rewarded.

I think it's important to keep the pressure on Forest. Settling with the government is one thing, now it's time to settle with the people they duped - the public.

A cynic would suggest that this is just about the dollar, they'd be wrong. This is about getting your teeth into a pharmaceutical company and biting them so hard that they think twice about doing any dirty deeds again.

If I had my way I'd put those responsible behind bars, to promote something that is harmful to any human is wrong, to promote it for children is despicable and abhorrent. Sadly, the only way to hurt big bad pharma is in the pocket and media.

Forest have made two settlements, they should now cough up to those who matter, the parents who forked out money for weekly prescriptions of Celexa and Lexapro.

The fact that some kids never experienced any adverse reaction is irrelevant here. The fact is both Forest Labs and Forest Pharmaceuticals played Russian roulette with children and for that two things should happen.

1. They should be held accountable.

2. They should compensate those they played Russian roulette with.

Both Forest Labs and Forest Pharmaceuticals made huge profit from Celexa and Lexapro, they did so by basically using children as guinea pigs, they did so by wining and dining doctors so they would prescribe more Celexa and Lexapro to children, they did so by withholding negative data about both drugs, data that showed that Celexa was no more effective than placebo for pediatric use.

Why should any company, be they pharmaceutical or a fizzy soda drinks company benefit from putting children's lives at danger?

So, did you or do you know anyone that paid for prescriptions for their children and/or adolescents for Celexa and Lexapro between 2001 and the present day? If so, then you may want to represent a class action in your state.

You can find out more information by calling 800-827-0087 or by filling in an online form HERE.

Forest Labs and Forest Pharmaceuticals should not benefit from your purse, particularly when the products they promoted for children and adolescents were actually dangerous for this vulnerable population. Their shareholders should not benefit from your purse either, namely, Wellington Management Company, LLP, Icahn Associates Corp and many more.

The full complaint can be read, in PDF form, HERE.


Bob Fiddaman

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