Panorama: Prescription For Stigma?

By Bob Fiddaman & Kristina Gehrki

This week I watched BBC's eagerly anticipated Panorama documentary, "A Prescription For Murder?" I say 'eagerly anticipated' because on the day it was scheduled to air, organizations that routinely run from public dialogue were tweeting away in the wee morning hours. This includes the Royal College of Psychiatrists (RCP) and the Medicines Healthcare Products Regulatory Agency (MHRA). They took to Twitter long before viewers had an opportunity to view and judge Panorama's programme on its own merits.

MHRA, RCP and other so-called "mental health" organizations, claim the show stigmatized those who use antidepressants. RCP tweets included:

#BBCPanorama claims irresponsible and unfounded. Scaremongering title alone shows real stigma people taking #antidepressants face.

More #antidepressant prescriptions=more people getting help. Not more potential murderers. Don't stigmatize people needing help #BBCPanorama 

Professor Louis Appleby later chirped:

A media throwback: sensationalist, exploitative, not even new, with stigma & risk to patients collateral damage.http://www.bbc.co.uk/programmes/b08zjyp1 …

The MHRA's limp-wristed, London-based suits tweeted:

SSRIs have been used to effectively treat millions of people worldwide & like all medicines, the safety is continually monitored. (Notice that MHRA did not state "SSRI drugs do not cause an increase in suicide or homicide.")

I immediately tweeted back:

You forgot to add that your CEO is the former World Safety Officer for @GSK

Many other mental health charities and patients tweeted their disapproval. A majority of complainers seemed annoyed by the documentary's title. I pointed out the title had a question mark after it, ergo it was posing a question, not making a statement. But this obvious fact seemed to be lost on those who bombarded Panorama's Twitter page.

Out With the Old, In With the New

For decades, Big Pharma has made wildly inaccurate claims about everything from the chemical imbalance theory to the legitimacy of their own "science." Today the old chemical imbalance campaign seems to be replaced by the new stigma campaign. It is an emotional appeal to try and convince the public that people who speak on behalf of drug safety are shaming those who consume prescription drugs. The reality is that drug safety advocates only want consumers to know the real risks so they can make an informed personal choice.

Drug companies, regulators and "mental health" organizations aggressively brand drug safety advocates as "stigmatizers." They want the word "stigma" to carry similar emotionally-charged perceptions as the word "racism." This diversion is sickly twisted, but a clever communications tactic nonetheless.

The problem is stigma isn't relevant to drug safety discussions. As Thomas Insel, former director of the National Institutes of Mental Health (NIMH), discusses in the documentary "Letters from GenerationRX," stigma isn't even much of an issue in seeking mental health "treatment." Insel states "The fact is that actually more people are getting more treatment than ever before" and yet the suicide rate "has not come down." The reason, surmises Insel, is "We (the mental health profession) don't know enough."

To see Insel's interview and the tragic SSRI experiences of many families, "Letters from GenerationRX" is available here.

The stigma campaign is designed to create a false public rift to hinder open dialogue about medical freedom of choice and drug safety. Drug companies don't want people to recognize it is a fundamental human right to know the real risks vs. benefits of their product before consumption. Few consumers would consciously choose to forego this right and Pharma, the MHRA, and RCP know it.

Their propaganda is a recipe for disaster. To ignore serious side effects causes thousands of deaths. These organizations create an imaginary enemy and imaginary "war" of sorts. Pit two sides against each other and stir the pot. They then sit back, enjoy the heated conflict, and stealthily pad their pockets.

Brief Summary of "A Prescription For Murder?"

Panorama's hour-long documentary mainly focused on mass murderer James Holmes. It posed the question of whether the SSRI Holmes was prescribed before the Colorado shootings played a role in his actions. The drug Holmes was prescribed in increasing doses is called sertraline, better known by its brand names of Lustral and Zoloft. It is made and marketed by Pfizer Pharmaceuticals. As Pfizer's own scientist, Dr. Roger Lane, has confirmed, Zoloft and other SSRIs can cause akathisia. Lane describes akathisia as "subjective distress" and "unbearable discomfort." He states akathisia sufferers "can feel death is a welcome result" to end their symptoms. (Source) - The source is hosted on Woody Matters, a website created by the wife of Woody Witczak, Kim. Woody died a violent death after taking sertraline for a total of 5 weeks with the dosage being doubled shortly before his death.

Panorama's investigative reporter, Shelley Jofre, interviewed many sources to include Holmes' parents, the prosecuting attorney, and several healthcare professionals. The show also briefly featured two other tragedies, that of Shane Clancy, who experienced adverse drug reactions (ADRs) from citalopram (1)  The programme's aim, as I see it, was to explore whether the connection between SSRIs and violence is legitimate.

The documentary, which hasn't yet aired outside the UK, was a year in the making and appeared well-researched. I won't give away too much program info because many people outside the UK haven't yet seen it. Suffice it to say; it was riveting.

(Note: In 2002 Jofre aired "The Secrets of Seroxat." It focused mainly on SSRI withdrawal problems but also shared the tragedy of 60-year-old Don Schell. After taking just two Seroxat tablets he killed his wife, daughter, and infant granddaughter before killing himself. ) Jurors ruled in favor of the man’s relatives and also ruled that taking Seroxat was the proximate cause of all these deaths.

Real Data Linking SSRIs to Violence

The MHRA is, according to the programme, aware of at least 28 homicides associated with SSRIs. Further, 32 additional reports have been sent to them showing an association between homicidal thinking and the use of SSRIs (Fig 1).

Fig 1

Predictably, the MHRA has never followed up these reports as it is not in their financial interests to do so. Therefore, they can then continue to claim that, "although these drugs have been associated with homicide and homicidal acts, it doesn't mean that the drugs caused the acts." It's akin to an airline ignoring reports of loose rivets and refusing to conduct any investigations in response to the reports received. After the plane crashes and innocent people die, the airline officially declares "We can't be certain loose rivets caused the crash."

This week's Panorama documentary further confirmed for me that those who cavalierly promote and push these drugs at alarming rates, while loudly crying "stigma," are actually trying to stigmatize those who have been harmed by the real effects of these drugs. Further, they don't value all human lives equally: those who suffer fatal side effects seem inconsequential.

A publicly-funded PR campaign doesn't exist for those who have suffered and/or died from these drugs. We don't have well-oiled PR machines to spin false data nor journalists ready to write misleading stories in the mainstream press. We don't take drug money in exchange for dishonest research. When we speak truth to medical power, it is we who are negatively labeled by an uncaring profession and corrupt regulators who have personally profited from drug industry ties.

But there is one thing we do have--something priceless that no marketing budget can buy: our honest and real lived experiences. If you're still uncertain about the adverse drug reactions Zoloft and other SSRIs cause, read the diary entries of a barely nineteen-year old girl who unwittingly documented her adverse drug reactions and psychiatric abuse. Natalie Gehrki, barely 5 feet tall and 110 pounds, was prescribed Zoloft in increasing doses. Her final dose was prescribed over the phone without ever being seen by her doctor. The doctor did not inform Natalie's mom that an increase had been directed and since Natalie already had the Zoloft prescription in hand, she simply took the maximum dose as her trusted doctor instructed.

Like Holmes' doctor, Natalie's doctor failed to recognize signs of SSRI-induced akathisia, and she increased the offending drug (Zoloft). Holmes was prescribed 150 milligrams of Zoloft at the time of his psychotic murders spree; Natalie was prescribed 200 milligrams and violence ensued a few days after consumption. Blood tests later showed Natalie was not an efficient metabolizer of SSRI drugs. Oh, well; perhaps the FDA might look into metabolization issues one day so other children might live?

"Netherworld," Natalie's story produced by Miller, is available for free here.

Further SSRI/Homicide related cases

Investigative reporter, Andrew Thibault, has uncovered much more through a series of Freedom of Information requests from the Food and Drug Administration (FDA). Many of the documents were heavily redacted, but all have one thing in common: All patients carried out an act of homicide whilst under the influence of a SSRI. The documents have been made public, and I wrote a series of blog posts about this back in 2016.

Seroxat/Paxil (paroxetine) - GlaxoSmithKline
Cipramil/Celexa (citalopram) &  Lexapro/Cipralex (escitalopram) - Lundbeck/Forest
Prozac (fluoxetine) - Lilly
Lustral/Zoloft (sertraline) - Pfizer

To view A Prescription For Murder, go to the BBC IPlayer here. (UK ONLY)

Shout out to Katinka Blackford Newman, author of The Pill That Steals Lives, who was the development researcher for this programme.

Bob Fiddaman & Kristina Gehrki


1. When Leonie and Tony Met Lundbeck (citalopram manufacturers)

The Homicide Files: Celexa & Lexapro

Following on from my last post, The Murderous Pills and The Keystone Cops (FDA), which highlighted 6 cases of Paxil related homicide, I now turn my attention to Celexa, known in Europe by its brand name of Cipramil and better known as its generic name of citalopram. Also included is the sister drug to Celexa, namely, Lexapro, known in Europe by its brand name of Cipralex and better known as its generic name of escitalopram.

Once again I will highlight just 6 cases of prescripticide* ~ there are many more in the Murder Meds database.


AERS Case Number 6301497

Homicide by male (age unknown. The patient was taking Celexa (40mg per day) between October 2003 to an unspecified date.

This was sent to Medwatch from a court clerk who had heard the evidence of the accused at trial. Pay particular attention to the side effects leading up to the murder. (Click on images to enlarge)

http://www.murdermeds.com/index.php/2016/01/30/aers-case-number-6301497/

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AERS Case Number 7574444

Homicide by male (78). The patient was taking Celexa (20mg per day) for just 5 days.

Notice, in the report, how his whole mood changed once he started Celexa therapy.

http://www.murdermeds.com/index.php/2016/01/22/aers-case-number-7574444/

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AERS Case Number 5850018

Homicide by male (54). The patient was taking Lexapro, unknown dosage, over a period of 2 to 4 weeks.


As you will see, the patient had no prior history of violence or aggression.

http://www.murdermeds.com/index.php/2016/01/16/aers-case-number-5850018/

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AERS Case Number 7274376

Homicide by male (37). The patient was taking Lexapro, 10mg, over a short period of time before he shot and killed his girlfriend and critically wounded a young man. He then failed in his own suicide attempt.

http://www.murdermeds.com/index.php/2016/01/21/aers-case-number-7274376/

--

AERS Case Number 6044971

Homicide by male, 55, (Initially the report said he was 40 but this was later rectified)  The patient was taking Lexapro, unknown dosage, over an unspecified time before he shot and killed his wife.

Remarkably, his treating physician did not consider that Lexapro played any part in the, seemingly, induced psychosis. Something that truly baffles me given that this is based on an assumption of the doctor and not scientific evidence.

http://www.murdermeds.com/index.php/2016/01/17/aers-case-number-6044971/

--

Finally, the last case is familiar as it concerns 22 year old Shane Clancy from Ireland. His name is omitted from this report. After reading it may be worth listening to the podcast (Link after images) 3 pages of the 6 page report have been redacted (for reasons unknown)

Shane was on citalopram for just 17 days.

AERS Case Number 7164838

(Listen to Podcast for full details)

http://www.murdermeds.com/index.php/2016/01/21/aers-case-number-7164838/

The above case is explained in great detail in the following Podcast recorded between myself and Shane's mother, Leonie Fennell, back in 2011.

Bob Fiddaman.

*Prescripticide ~  is defined as a death that is caused by an adverse reaction to a prescription drug.

Previously in this Homicide series...

The Murderous Pills and The Keystone Cops (FDA) - Paxil

Database available on Murder Meds.

This blog post is dedicated to the memory of Shane Clancy.

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)

Q&A With Leonie Fennell

Imagine, if you will, a Sunday morning. You have that extra hour in bed with your partner. You can hear the kids downstairs playing, the TV is blaring, their laughter makes you smile.

You climb out of your slumber and head for the kitchen, breakfast is soon on the go and you all sit down as a family to eat.

Imagine, if you will, a knock at your door. On answering you see two police officers.

They are the bearers of bad news ~ they tell you that your son is wanted for questioning, moreover, they tell you that he is suspected of killing someone.

Imagine, if you will, during this visit a message comes through on one of the officer's walkie-talkies. "We've found the suspect, he's at the rear of the property... he's dead."

The unthinkable.

Leonie Fennell and her husband Tony don't need to imagine. This is their reality.

I first met both Tony and Leonie at an award ceremony in East Grinstead. We stayed up until the small hours talking about their son, Shane. It, for me, was heart-wrenching to hear and see two broken parents, particularly as my roots stem from Ireland (my mother being born and raised there)

We kept in touch and I've popped across the Irish sea to see them both on a number of occasions. Words cannot describe this beautiful couple, this beautiful family ~ all plodding along after such a tragedy. I've met Leonie's extended family too, a wonderful bunch (clan) who made me feel so welcome.

Leonie, as you will see from the Q&A's, has been very vocal in her mission to raise awareness about antidepressants. Shane was just 22 when he broke up with his girlfriend. He was heartbroken - he was prescribed the powerful antidepressant, citalopram (known as Celexa in the US). A month or so later Shane committed homicide and then killed himself, two acts brought on by induced psychosis, an adverse side effect of citalopram.

Tony and Leonie have been a part of my 10 year journey with this blog. I love them both dearly.





Full name: Leonie Fennell
Age: 50
Location: Wicklow, Ireland.



Q: Leonie, now that you have established yourself as a blogger, do you feel that your work over the years has brought about change in the way that many feel about antidepressant use?

A: Surprisingly, I do. The feedback suggests that the public are far more enlightened to the harms that come directly from putting harmful chemicals into our bodies. It has taken a long time for people to realise that medicines (prescribed by a friendly GP), while often doing good, can equally cause huge harm. When I started out in 2009, antidepressants were mainly seen as harmless happy-pills. People now seem far more cautious and whether they believe me or not, is irrelevant. Being aware of issues can often mean an adverse reaction is recognised for what it is - caused by the drug and not the supposed ‘illness’.  I think, in Ireland at least, largely due to the work of Irish doctor David Healy, people are questioning over-medicalization, particularly of our children. The tide is definitely turning on the pharmaceutical industry.


Q: They say that behind every good woman is a good man (or something like that). Your other half, Tony, has, I know, been a tower of strength for you and your family. How important is it, for you, to have the support of Tony?


A: He’s amazing - my rock. Don’t tell him I told you though, wouldn’t want him to get a big head. Joking aside, Tony has kept us all going, through thick and thin, through the laughter and the tears. He’s like a big soft cuddly toy - a bit battered and bruised, but totally-loved teddy bear. He was a broken man when Shane died and while the scar tissue must surely be visible under a microscope, he’s survived to battle on, especially for Shane. As a family we still laugh often - sometimes at Tony, but usually with him. I think he quite likes it.

Q: Back in 2011 you and Tony travelled to Denmark to meet with Lundbeck. The subject matter, in the main, was about citalopram (Celexa), the antidepressant that induced psychosis is your son, Shane. Can you tell me more about that meeting and how you feel it went?

A: To be honest, it wasn’t too surprising. I think the Lundbeck officials we met actually expected us to accept their denials and walk away hand-in-hand into the Copenhagen sunset. Instead, they just confirmed what we knew already, that most pharmaceutical companies will lie and cheat in order to cover up the harms done by their chemicals. The many deaths, like Shane’s, are brushed aside as collateral damage, a nuisance. The meeting was a bizarre experience.

Q: On average, how much time do you spend with work that relates to your blog?

A: Many, many, hours. I could often spend entire days doing research, which may or may not turn out to be useful. It’s my form of relaxation and I could quite happily sit in the midst of chaos while working on a particular subject.

Q: 2011 was, it appears, a busy year for you. In the summer of that year you were contacted by solicitors with regard to something you wrote about Irish psychiatrist, Patricia Casey. Can you tell me what all that was about and what was the outcome?

A: Casey is probably one of Ireland’s most widely recognised psychiatrists. She often sends people solicitor’s letters when she gets offended – which is quite frequent. I have never been reticent about being shocked and distressed when she commandeered Shane’s inquest, arriving uninvited to offer her assistance to the coroner. After her offer was ignored, she then wasn’t happy with the jury’s decision (an ‘open’ verdict). Directly after the inquest, on the steps coroner’s court, she proceeded to speak to the waiting media, stating there were aspects of the evidence that the college (of psychiatry) took issue with. I think her issues were with Dr David Healy, who testified that these drugs can be dangerous, in particular that SSRI antidepressants can cause suicide and violence. Later, she took offence against a blog I wrote about her and sent me a solicitor’s letters for my troubles. I then published the letter saying I would not be bullied or intimidated by Lundbeck or anyone else – so she sent me another one and I published that too. I think you know you’re on the right track when you get a ‘Casey Correspondence’.

Q: Congratulations on graduating with a law degree. It's a wonderful achievement. What made you decide on studying law?

A: I started studying law the year after Shane died. I basically wanted to find out how the pharmaceutical companies were getting away with harming people on this side of the Atlantic, when in the U.S. cases are regularly settled or the pharmaceutical industry are found guilty. Same drugs, same humans but warnings provided in the U.S. and none here – it’s a ridiculous situation. There will be no accountability until the legal system and our governments takes steps to sanction wrongdoing by these enormous companies. At the moment companies like GlaxoSmithKline and Lundbeck are being permitted to run rough-shod over Europe. The law degree helped me to understand the situation, but not accept it. I should say though, that I thoroughly enjoyed every second of doing law with my lovely colleagues and lecturers -  it was a great distraction.

Q: Would you recommend blogging to parents, or anyone for that matter, who had lost someone dear to them through antidepressant induced suicide?

A: I certainly would. Apart from being another great distraction, it’s a cheap form of therapy. It helps to get things in perspective and enables many diverse conversations. I do know that my family was helped enormously by other bloggers, particularly you and Truthman. It’s such a huge revelation when you find others in a similar situation, having thought you were alone. Sadly, there are many more victims and bereaved families since – yet, as there are more experts willing to speak out (Peter Gøtzsche for example), I think positive changes are coming fast.

Q: As an outsider looking in (kind of) I am amazed at your commitment and tenacity. What is it that keeps you going?

A: That’s easy – Shane. He was just so lovely, kind, funny and caring. I think of him every second of every day and the injustice of his death keeps me going. He was very like me and would have fought many injustices in his 22 years. I believe with every fibre of my being that Shane died because of Citalopram.  Therefore, I could never have moved on, taken the other option - to live a relatively easy life, albeit one without Shane.  To do that would have been to actively enable similar deaths to happen to others. It was never an option. It helps that there are so many of us in the same boat, helping each other out.

Q: Have you ever considered writing a book about your journey?

A. I have and it’s about 2/3 of the way finished. It’s just a matter of time, which I never seem to have enough of. The goalposts keep moving, with so much emerging pharmaceutical information. Shane’s personal story is fighting with my academic side and I’m trying hard to marry both and still keep it interesting.

Q: What do you say to people who believe that antidepressants are safe and effective?

A: Some people seem to be able to take antidepressants without coming to any harm. Whether through the placebo effect, or otherwise, some say they are helped by them. There are many reasons for this, not least that people usually get better with or without medication. Nevertheless, we know that these drugs are neither safe nor effective for the majority of people that take them, with experts saying they are causing ‘more harm than good’. We know they can double the risk of suicide and violence, cause mania, increased depression and a myriad of other harmful effects, including heart problems and stroke (causing many fatalities). Two innocuously-sounding effects that fascinate me are emotional-blunting and disinhibition – effectively meaning that a huge percentage of people could be walking around with sociopathic tendencies. No doubt future generations will look back and see this era of mass-prescribing, as ludicrous. I would advocate vehemently for fully-informed-consent, a practice sadly lacking in Europe.

Q: I see from your Facebook profile that you have an annual dip in the river each December. Can you tell me more about that and other charity work that you are involved with?

A: My family do the Christmas Day swim in Sandycove every year, to raise money for the Simon Community. I don’t if I can get away with it and instead, I pay to get out of it. I spend from January to December dreading it, so I bribed Tony into doing it last time and happily looked on from the side-lines at all the blue bodies. For some strange reason, one that I could never fathom, my mother, brothers, sisters and cousins love jumping into the freezing Irish sea – I don’t.

Q: When I spent time with you and Tony in Ireland you told me about Shane's gesture on his 21st birthday. (Church) For the benefit of this Q&A can you tell the readers about this wonderful gesture?

A: It wasn’t the church, it was the St Vincent De Paul, a charity he was very fond of - he worked there as a volunteer. Shane was very kind-hearted, always eager to help those who were unable to help themselves - so much so that he was referred to by his lecturers as ‘an chroi mór’ (Irish for the big heart). For his 21st birthday party in 2008, Shane asked everyone to make a donation to the St Vincent de Paul rather than buy him a present.  He told everyone he didn’t need presents, that he had everything he could possibly need.  He wrote the following words on his official 21st party invites...

“…despite the fact that my parents neglect me [joke], believe it or not I am spoiled.  So instead of spending money on a card or anything else, please make use of the St. Vincent de Paul box on the night where you can give the money to someone who needs it as I have everything, thanks. Shane”

Q: For you, what is the most frustrating part about being a patient advocate?

A: What frustrates me most is lackadaisical journalists who come looking for newspaper fodder. They often look for contacts details (of medical experts and bereaved parents) and I’ll happily do what I can to help. Occasionally though, they look for ‘all the up-to-date evidence’ and I can spend days doing research, effectively doing their job for them. Nevertheless, I persevere just because I’m thankful that iatrogenic harm will be discussed – how sad is that? I wish there were more good scientific journalists, who would use their own initiative and do their own research. We could do with some good medical and science writers over here – I wonder could we adopt Robert Whitaker or Mikey Nardo?

Q: Where do you see yourself in 10 years time?

A: Besides pottering around Wicklow with Tony, having recovered from the empty-nest syndrome and if I haven’t kicked the bucket, I see myself teaching Pharma-Ethics (unethical ethics), or something similar. I hope to put my years of studying, research and life-experience to good use and have many projects in the pipeline. However, I wouldn’t have predicted living the life I now lead, so who knows?

Q: Finally Leonie, some personal questions...

1. What book are you currently reading?

A: I’m studying at the moment, so the book that comes everywhere with me is ‘Principle of Biomedical Ethics’ by Beauchamp and Childress. It’s actually not as bad as it sounds.

2. What was the last CD you listened to (in full)?

A: The Best of John Denver (in the car while I waited for the boys to come out from Jiu-Jitsu training).

3. What is the best movie you have seen this year?

A: ‘Daddy’s Home’ with Will Ferrell and Mark Wahlberg (in the cinema with my 17-year-old son Jack). Absolutely Hilarious - although I think Jack was a little mortified in certain parts.

4. What country would you most like to visit?

A: Italy. We went for a day-trip to Ventimiglia last year (from Monaco) and it was just so incredible. It made us want to return to see more: the old buildings, the markets, the food, the people, the sun, the double decker trains –  sweet memories!

5. If you had the choice of being either a defence or prosecution lawyer, which would you choose and why?

A: Not sure I understand the question, a good lawyer should do both I think. While we’d all love to change the world like Erin Brockovich, if the defending lawyer doesn’t defend the accused to the very best of his ability (particularly if he believes him to be guilty), that may leave the option open for a re-trial or a mistrial. We can all have subjective opinions, but a good legal system should be based on objectivity. HOWEVER, I can’t say I’d be very objective if I was to represent a victim of the pharmaceutical industry.



Leonie Fennell Blog

Leonie's Twitter Page



Bob Fiddaman



Previous Q&A's

Q&A With Ablechild's Sheila Matthews-Gallo

Lundbeck: Contradiction in Terms

One of the more popular posts on this blog over the past couple of years has been a guest post by Scottish mom, Cheryl Buchanan. In short, Cheryl aborted her fetus at 23 weeks because she was told that its chances of survival were slim due to several defects.

A series of other posts by Cheryl and myself have appeared on this blog and now, it seems, the mainstream media in the UK have taken an interest. All good, I hear you cry - I guess so, it's good when stories like this are highlighted in the British press but, to be honest, journalism isn't what it used to be. In fact, the article, published on Jan 10 in The Express, leaves more questions than answers, questions that really should have been asked by the reporting journalist, Paula Murray.

Her article highlights Cheryl's plight and also tries to offer balance in the shape of a quote from Lundbeck's Medical Director, Dr. Andrew Jones.

Dr Andrew Jones, Medical Director with Lundbeck, said citalopram should not be prescribed during pregnancy unless "clearly necessary and only after careful consideration of risk/benefit".

However, he said there was "considerable evidence" to show that women who stop taking antidepressants during pregnancy are more likely to suffer a recurrence with "greater risks to the woman and her unborn child than the potential risks of exposure to the medication".

Dr Jones added: "We are familiar with Ms Buchanan and have supported her with the information she has requested. It is always a tragic situation when one loses a child. We will not comment on her personal case in public but the safety of Lundbeck’s antidepressants is supported with the large amount of data that has shown no evidence of an increased risk of birth defects associated with treating pregnant women with citalopram."

I left a comment on the Express article suggesting that Jones was having his cake and eating it, sadly, for some bizarre reason, that comment has been removed. Kind of weird given that the journalist in question was given the links to Cheryl's story that have appeared on my blog over the past couple of years.

Why didn't the journalist ask Dr. Jones for the  "considerable evidence" that shows that women who stop taking antidepressants during pregnancy are more likely to suffer a recurrence with greater risks to the woman and her unborn child than the potential risks of exposure to the medication?

Why didn't the journalist ask Dr Jones about the citalopram animal reproduction studies where it was shown that citalopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects resulting in in decreased embryo/fetal growth and survival and an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects) (Source FDA)

Furthermore, why wasn't Jones pushed for an answer in defining the terminology, Possibly, Probably or Certain? There's a whole new can of worms there for anyone seeking that Pulitzer.

Contrast the citalopram animal reproduction studies with the claim of Dr Jones that women who stop taking antidepressants during pregnancy are more likely to suffer a recurrence with "greater risks to the woman and her unborn child - it's a theory folks, one that has been blown out of the water many times by other academics. The citalopram animal reproduction studies is the actual science here and really should have been picked up by the reporting journalist.

Dr Jones is towing the company line, ie; he's keeping lawyers at bay and expectant mothers at risk - throwing in the line, "citalopram should not be prescribed during pregnancy unless clearly necessary and only after careful consideration of risk/benefit", is nothing more than a mandatory disclaimer used by pharmaceutical companies, they know their drugs are being used in pregnancy yet they just sit back and allow it to happen because they believe the prescribing physician is in a better position to judge whether or not the patient will benefit from the drug. Lines such as " women who stop taking antidepressants during pregnancy are more likely to suffer a recurrence with "greater risks to the woman and her unborn child", will always persuade prescribing physicians that antidepressant drugs are a must for depressed mothers - even though this statement is merely a theory.

Begs the question why Jones failed to mention the citalopram animal reproduction studies to the investigating journalist.

Meantime, Cheryl Buchanan remains in limbo and her child, through no fault of her own, remains dead.




Bob Fiddaman.

Back Stories

Citalopram Birth Defects (Guest Post)

Are Lundbeck Luring Pregnant Mothers With a Red Apple?

Lundbeck: Possibly, Probably or Certain about Celexa Birth Defects?

Two Facebook Statuses That Say It All

Seroxat (Paxil) withdrawal...

If you, like many thousands, find difficulty when trying to wean yourself off Seroxat (known as Paxil in the US and Aropax in Australia) then you'll know that there is no guidance.

The manufacturers, GlaxoSmithKline, refuse to help - Any correspondence sent to them during your horrific withdrawal will be met with the bog standard replies of "We are not allowed to discuss individual cases blah, blah..."

Your prescribing healthcare professional will, more than likely, refer to the product monograph which really tells them that there isn't a huge problem when patients taper from Seroxat - the product monograph, if you didn't know, is crafted by the drug company.

The medicines regulator, be they the British MHRA, the American FDA or the Australian TGA, will shrug their shoulders then scurry back to their various rat holes in the hope that you don't disturb them again.

Internet forums will offer various tidbits of information, you'll show your prescribing physician and he/she will probably tell you that these types of forums are run by conspiracy theorists.

~Bob Fiddaman


--

As I was getting nowhere debating back and forth with the MHRA and Pharmaceutical company Lundbeck I decided to write to the Minister for Public Health, Jeremy Hunt, about my daughters death which I believe was caused by the SSRI Citalopram. She was fatally malformed, incompatible with life. I had been given a "prescribed overdose" (according to lundbeck) by my GP unwittingly throughout the pregnancy and thoroughly reassured that it was not a teratogen. I was on a prescribed dose of 60mg, this dosage was the maximum back in 2004, but was lowered a few years ago to 40mg by the manufacturer and the MHRA as it was known to cause the heart condition "Long QT syndrome" and sudden death in adults. Today I was very surprised to have received a response -

Dear Miss Buchanan,

Thank you for your correspondence of 5 October to Jeremy Hunt about citalopram. I have been asked to reply.

I was very sorry to read about the death of your daughter and the circumstances surrounding her cremation.

However, the Department of Health is unable to comment on individual cases.

The Medicines and Healthcare products Regulatory Agency (MHRA) has provided the following information.

Citalopram is a member of the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). SSRIs are used to treat depression in pregnant women in cases where there are no safer alternative effective treatments. The decision to prescribe SSRIs requires a careful evaluation of the need for treatment and any known risk of harm to the mother and/or foetus. Untreated depression during pregnancy is known to be harmful to the mother and foetus.

Some studies have suggested a small increased risk of birth defects with some SSRIs. Data has shown that paroxetine and fluoxetine are associated with an increase in risk of birth defects in the baby if the mother takes them in the first trimester. The background rate for birth defects is two to three per cent of all pregnancies. Current available data is insufficient to prove birth defects occur more commonly after taking citalopram than this background rate.

It is known that all the SSRIs can be associated with an increased risk of persistent pulmonary hypertension, a heart condition in the newborn, when taken later in pregnancy. Neonatal withdrawal and toxicity reactions have also been reported when SSRIs are taken in later pregnancy.

Several important changes to the citalopram prescribing information were introduced by the MHRA in 2011, including maximum dose restriction in adults after a detailed review of data showed citalopram was associated with a dose-dependent increased risk of abnormal heart rhythm.

The MHRA continues to monitor the safety of use of SSRIs in all patient populations very closely and all new data are rigorously assessed to evaluate the need for further regulatory action.

I am sorry I cannot be more helpful, but I hope this reply helps to clarify the situation.

Yours sincerely,

Malcolm Jones
Ministerial Correspondence and Public Enquiries
Department of Health

-------------------------------------------------------------------------------------------------------

I'm sorry to see that, once again, I have been given the usual spiel about the MHRA monitoring medications such as these, but what use is monitoring them if, when issues are flagged up, they chose to do absolutely nothing about it? I have never had once single invitation from the MHRA to converse with them or provide them with further information on my daughters death, this is despite me contacting them fairly regularly for over the past two years.

What else can I do? Is there anywhere else I can turn, anything I can try? I'm not giving up on this. I won't ever give up.


Cheryl Buchanan


--


Says it all really...



Bob Fiddaman

She Feckin Did It!

Imagine waking up Sunday morning to a knock on your door. Your Saturday night quickly forgotten as you open the door and are greeted by the Police, in this instance it was the Irish Garda (An Garda Síochána)

They ask you if you know the whereabouts of your son, furthermore, they tell you that he was involved in an incident where someone was killed.

What would your reaction be?

As your Sunday unfolds you are once again contacted by the law enforcement of your particular country. "Your son," they tell you, "has been found." They continue, "I'm sorry to inform you that your son is dead."

Just comprehend the above scenario. I've tried but plummeting myself into such a scenario really means nothing. Rik Mayall is on my TV, I don't need to put myself in anyone's shoes to feel their pain. I have potatoes on the hob boiling - why would I want to paint a picture of someone else's problem?

Leonie Fennell is a friend, more importantly, she is a mother. It was she that endured the above scenario, along with her husband, Tony.

I've heard them both relive that day and felt sickened. It would be a lie to say I felt their grief, how could I, how could anyone? Yes, of course, as a human I felt their pain, at least a very small amount of it. It's a pain that both Tony and Leonie carry around with them every day.

As the years have rolled on their nightmare has been rehashed in various newspapers and documentaries. Their dead son, Shane, has been labelled and mocked even though an inquest on his death returned an open verdict. This, after it was learned, that Shane stabbed himself in the chest 19 times after fatally wounding a young Irishman.

Psychiatrists, who, in the main, make their name through column inches in the press, have offered their opinion. Shane had a mental illness, he was driven to a mad rage of jealousy, etc, etc, etc.

These same interfering white-coated buffoons ignore the suicide/homicide link related to the drug Shane was taking at the time, Cipramil (citalopram) - marketed in the US as Celexa.

Anyway, I don't want to dwell on the past. Shane's story (the honest truth) can be read on Leonie's blog (link at the end of this article)

So, to the title of this post, "She Feckin Did It!"

Well, I can imagine Leonie now, speed reading through this piece of mine, uttering under her breath words such as 'fecker'. She'd be embarrassed by it all.

You see, despite suffering the heartache of losing her son, despite having fingers pointed at her and her other children, despite the chin-wagging of those that never really knew her son, Leonie has battled on. A popular blog, threatening letters from lawyers representing an Irish psychiatrist and even a trip across to Denmark to visit Lundbeck, the manufacturers of the drug that killed her son, a meeting that was covertly recorded too - much to my delight :-)

So, what do you do when something as hellish as losing a son in such a bizarre manner?

Leonie did what she was driven to do and now she has graduated with a LLB (Legum Baccalaureus or Honours Bachelor of Laws) from ITCarlow.

Leonie set out five long years ago on a journey, she writes...

Five years ago I ventured out of my comfort zone as a scared, scarred and grieving ‘40 something’ – as a third level rookie. I had decided on a ‘Foundation in Law’ course in Dublin’s Institute of Technology, Aungier Street, more by accident than any foregone design. Having attended an information evening (and handing over my Visa card), before I could utter “erm, not quite sure…”, I was duly plonked on a chair and photographed. Soon afterwards I found myself standing on the steps of DIT with a student card in hand, complete with obligitory dodgy student photo. I wasn’t sure whether to laugh or cry, but when I adjusted to the shock – it turned out to be one of my better decisions (the course, not the photo).

The whole story, ITCarlow – My Alma Mater, can be read here.

It's quite an achievement to pass any sort of course, particularly in that of law, which frankly is a mindfield of mind-boggling rules and regulations that we must all, apparently abide by.

I like Leonie's style, not her fashion sense, last I heard she was still wearing flared trousers and tartan scarves around her wrists. I just like her approach to blogging, her approach in offering support to those who need it, her approach to life in general.

Leonie is a funny woman, full of that stereotypical Irish wit. It's a pleasure to know both herself and Tony and their beautiful children. It's also my pleasure to publicly say, Leonie, you feckin did it!

Eiridh tonn air uisge balbh.


Bob Fiddaman.

Almost a Quarter of 'Suicide' Pilots on Psych Drugs

Well, wouldn't you know it.

CNBC are running with the headline, 'Germanwings crash prompts overhaul, calls for more mental health checks.' - only thing is, the article does not state who is actually 'calling.' Is it the airlines, is it worried passengers or is it those that work in the field of mental health?

On Thursday The Boston Globe ran a very thought-provoking article regarding the 24 US Aircraft-assisted suicides between 1993-2012.

The data collected showed toxicology reports for 21 of the 24 pilots. They were unable to obtain toxicology reports for 3 of the 24 pilots.

So, we have 21 pilots to work from.

Out of those 21 pilots, 5 were on psychiatric medication, or at least had psychiatric medication in their bloodstream at the time of the Aircraft-assisted suicide.

Case #8 - Pilot (41) - Diazepam, Nordiazepam (anti-anxiety)

Case  #9 - Pilot (40) - Alcohol, Cocaine, Diazepam & Nordiazepam (anti-anxiety), Temazepam (insomnia), Oxazepam (anti-anxiety/depression)

Case #14 - Pilot (54) - Venlafaxine, Desmethylvenalfaxine (depression)

Case #18 - Pilot (44) - Fluoxetine & Citalopram (depression), Diphenhydramine (allergic reactions/motion sickness), Alcohol

Case #22 - Pilot (25) - Alcohol, Citalopram (depression), Clonazepam (anti-anxiety)


It would be churlish of me to suggest that the drugs made them do it so, just like the Boston Globe data, I will show you the other mitigating circumstances.


Case  #8 - Marriage proposal declined

Case  #9 - Criminal history; suspect of arson

Case #14 - Under therapy for severe depression

Case #18 - History of depression w/ hospitalizations; shortly before the event, he was in hospital for attempted suicide

Case #22 - Distraught over breakup with girlfriend; alcohol and medication consumption prior to accident


Cases 14 and 18, it appears, show that the two pilots were diagnosed with depression and treated with medication. The other three cases don't seem so cut and dry.

Case 8 had a marriage proposal decline yet was found to have Diazepam and Nordiazepam (anti-anxiety) in his system. Was he being treated or did he just manage to get his hands on these tablets? If he was being treated then I cannot see anything in the Diagnostic Statistical Manual of Mental Disorders (DSM) that states that dealing with a marriage proposal decline is a mental illness.

Case 9 had a criminal history and was suspected of arson, yet in his blood system we find Diazepam & Nordiazepam (anti-anxiety), Temazepam (insomnia), Oxazepam (anti-anxiety/depression). Again, nothing in the DSM about using medication on someone with a criminal history.

Case 22 was distraught over breakup with girlfriend. In his system they found Citalopram (depression), Clonazepam (anti-anxiety). Since when does splitting up with a partner deem someone as being mentally ill?

So, a staggering 23.8% of pilots who took part in Aircraft-assisted suicides between 1993-2012 were on psychiatric medication/or had taken psychiatric medication prior to the suicide.

Now, we have more "calls" for mental health checks which will no doubt mean more pilots on psychiatric medication.



Now, let's take a look at the three pilots that they wasn't able to pull toxicology results from.

Case #11 - Restraining order; escorted away from home

Case #16 - Ongoing treatment for depression

Case #24 - Difficulties in personal life; joked about suicide


I think we can be, at the least, 90% certain that case 16 was on some form of antidepressant medication. If this was the case then it pushes the total figure of Aircraft-assisted suicides that were medicated up to 27.2% (6 out of 22 pilots)

If case 24 had difficulties in his personal life and was being treated, just as case numbers 8, 9 and 22 were, then the figure rises again to 30.4%

However, we cannot speculate.

The fact still remains. 23.8% of pilots who took part in Aircraft-assisted suicides between 1993-2012 were on psychiatric medication/or had taken psychiatric medication prior to the suicide.

Now let's breakdown the list of drugs.

Diazepam (2)
Nordiazepam (2)
Temazepam
Oxazepam
Venlafaxine
Desmethylvenalfaxine
Fluoxetine
Citalopram (2)
Clonazepam

Diazepam 

Side Effect Reports – By Outcome

Completed suicide (1,885 reported)

--

Nordiazepam 

Nordiazepam is the primary metabolite of diazepam

Completed suicide (1,885 reported) (diazepam)

--

Temazepam

Completed suicide (543 reported)

--

Oxazepam

Completed suicide (87 reported)

--

Venlafaxine

Completed suicide (1,818 reported)

--

Desmethylvenalfaxine

Completed suicide (147 reported)

--

Fluoxetine

Completed suicide (1,560 reported)

--

Citalopram 

Completed suicide (2,191 reported)

--

Clonazepam 

Completed suicide (1,924 reported)

I don't know about you but I'd much rather know if a pilot was on antidepressant-type medication given the above results, wouldn't you?

Now, here's the rub folks.

On April 5, 2010, the FAA announced that pilots who take one of four SSRi antidepressant medications – Fluoxetine (Prozac), Sertraline (Zoloft), Citalopram (Celexa), or Escitalopram (Lexapro) – will be allowed to fly if they have been satisfactorily treated on the medication for at least 12 months.

Two from that list, namely Fluoxetine and Citalopram, were found in the toxicology reports of pilots #18 and #22.

It begs the question, why did the FAA, in 2010, announce that pilots would be allowed to fly on 4 SSRi type medications, two of which have since been found in pilots who have used an aircraft as a choice of suicide?

Will be interesting if German authorities release details of the prescription medications they found in the apartment of Andreas Lubitz, although I suspect the media will focus on his state of mind rather that what prescription medication may have contributed to his state of mind.

It ain't rocket science folks but the mainstream media are still missing the bigger picture, as are the FAA and other aviation authorities.



Bob Fiddaman.



**Completed suicide figures obtained from RxISK drug database.



BACK STORIES

Co-pilot, Andreas Lubitz Germanwings

Andreas Lubitz - The Drugs Don't Work.

SSRIs Render Unfriendly Skies.

Documents obtained from the FAA under the Freedom of Information Act.

Shane 22nd February

Today marks the birthday of Shane Clancy. He would have been 28

Shane is yet another victim who fell foul of antidepressants. Sadly, another young man also became entangled in the adverse side effects caused by the citalopram (known as Celexa in US) Shane was taking.

Here's a podcast I did with Shane's mom, Leonie, back in 2011. Interview starts at the 5 minute 30 second mark.

Bob Fiddaman.

Lundbeck: Possibly, Probably or Certain about Celexa Birth Defects?

Possible or probable, so what is the difference?

I've struggled with these two definitions, really tried to get my head around them both.

First off I used Dictionary.com

Possible:
1. that may or can be, exist, happen, be done, be used, etc
2. that may be true or may be the case, as something concerning which one has no knowledge to the contrary

Probable:
1. likely to occur or prove true
2. having more evidence for than against, or evidence that inclines the mind to belief but leaves some room for doubt.
3. affording ground for belief.

When it comes to prescription medications causing adverse events, the World Health Organisation (WHO) use "causality categories" and define possible and probable as thus...

Possible:
• Event or laboratory test abnormality, with reasonable time relationship to drug intake
• Could also be explained by disease or other drugs
• Information on drug withdrawal may be lacking or unclear

Probable:
• Event or laboratory test abnormality, with reasonable time relationship to drug intake
• Unlikely to be attributed to disease or other drugs
• Response to withdrawal clinically reasonable
• Rechallenge not required

In essence both words have two possible outcomes yet both have different meanings.

I am going to focus on the case of Cheryl Buchanan here and her correspondence with citalopram makers Lundbeck. Citalopram is better known as Cipramil in the UK and Celexa in the US. ( Forest Laboratories)

Cheryl has been at loggerheads with Lundbeck regarding the death of her baby girl. Cheryl made the heart wrenching decision to abort her fetus at 23 weeks because she had been told that scans had detected a series of anomalies in her unborn child, namely...

• Diaphragmatic hernia or eventration
• Long bone immobility
• Cystic hygroma 
• Unilateral cleft hand
• Microgynathia

Cheryl had been taking Lundbeck's citalopram prior and during her pregnancy. She wrote a guest post for my blog back in 2013 and has since been trying to get answers from the Danish pharmaceutical giant Lundbeck.

Lundbeck carried out an assessment of Cheryl's claims and forwarded their findings to the MHRA.

Lundbeck, as far as I am aware, also use the World Health Organisation "causality categories".

Here's what they found.

(Foetal death in utero) - drug related - possible
(Pulmonary hypoplasia) - drug related - possible
(Diaphragmatic hernia) - drug related - possible
(Hand deformity) - drug related - possible
(Skin laxity) - drug related - possible
(Skin swelling) - drug related - possible
(Drug exposure in utero) - drug related - possible

Fig 1.

Fig 2. **Initial reporting from Lundbeck to the MHRA did not give any indication for Cheryl's fetus developing Pulmonary hypoplasia**

Fig 3. **Updated assessment by Lundbeck sent to the MHRA regarding a possible connection between citalopram related Pulmonary hypoplasia**

Sometime later Cheryl wrote to Lundbeck and asked if citalopram could cause birth defects?

Here's the reply from Lundbeck's Dr Andrew Jones, Medical Director, Medical Department.

"...there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population (i.e. of mothers not taking citalopram). " 

It was at this point that I wrote to Dr Jones to ask him if this was a personal opinion or an opinion of Lundbeck. He replied...

Dear Mr Fiddaman,

I confirm that this is the position of Lundbeck.

What I am struggling with here takes me back to the definitions of possible and probable.

Lundbeck assess Cheryl's case and write to the MHRA with their findings. They tell the MHRA that the birth defects (listed above) are possibly drug related. Using the WHO criteria this means that...

The defects could just be coincidental to Cheryl's "drug intake" or

The defects may possibly have been caused by "disease or other drugs" or

The Information Cheryl provided Lundbeck "may be lacking or unclear" 

Let's now take a look at the position of Lundbeck regarding citalopram use and birth defects. Remember, it was their own Dr Jones that told me that the following was the position of Lundbeck...

"...there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population (i.e. of mothers not taking citalopram). " 

So, how do we categorize the position of Lundbeck. Are they suggesting that it's possible that there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects?

Are they saying it's probable that there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects?

Or are they saying they are certain that there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects?

Back to the WHO criteria again.

Certain:
• Event or laboratory test abnormality, with plausible time relationship to drug intake
• Cannot be explained by disease or other drugs
• Response to withdrawal plausible (pharmacologically, pathologically)
• Event definitive pharmacologically or phenomenologically (i.e. an objective and specific medical disorder or a recognised pharmacological phenomenon)
• Rechallenge satisfactory, if necessary


Lundbeck have done nothing more than open the door for debate when sending information back to the MHRA.

Where the mother is concerned they have quite literally slammed the door on her face by telling her that their position is there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population.

Why would they (technically) tell the MHRA otherwise?

Why would Lundbeck tell the MHRA that it was possible that citalopram caused the birth defects in a mother's fetus but tell that same mother something completely different?

I'm confused by it all. Is the WHO criteria merely a set of probabilities with at least two possible outcomes? If so, it doesn't really tell us much does it?

Is the WHO criteria not as stringent as they think and each category open for debate?

What we basically have is two opposing statements of reality intertwined.

The third statement of 'certainty' by Lundbeck to Cheryl Buchannan being an ultimatum, in essence, "our drug does not cause birth defects", forgetting or purposely failing to add that they told the MHRA otherwise.

It's certain that Cheryl Buchanan aborted her fetus at the age of 23 weeks because, she was told, the chances of survival were minimal due to a series of internal defects.

My money is on citalopram being the cause of those defects.

Any good lawyers in the UK?

Bob Fiddaman.

Back Stories

Citalopram Birth Defects (Guest Post)

Are Lundbeck Luring Pregnant Mothers With a Red Apple?