Zantac Lawsuit

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

Sunday, April 29, 2012

Neonatal Abstinence Syndrome

Although the newborns featured in this video are mainly suffering from neonatal abstinence syndrome (NAS) as a result of their mothers taking pain medication during their pregnancies, there is an alarming number of babies that suffer the same when their mother's take SSRi medication throughout their pregnancy.

This has been admitted by GSK with regard to Paxil...but they didn't make a song and dance about it.

One would have thought an advertising campaign on national TV or full page newspaper spreads would have been the order of the day, alas, GSK much prefer to post their warnings on their website. One can only find it if one knows what they are looking for.

This from GSK's webpage:

Levinson-Castiel et al found a 30% (18/60) rate of neonatal abstinence syndrome (NAS) [45% severe and 55% mild] in a large population-based study that included infants with a reported prolonged in-utero exposure to SSRIs.(53) Of these neonates 62% (37/60) were exposed to paroxetine at a dose range of 10-40 mg.

To get some sort of idea what paroxetine withdrawal in newborns may look the video from CNN.

Neonatal abstinence syndrome is just one of many conditions SSRi can cause in newborns. The British drug regulator, the MHRA, and their American counterparts, the FDA, are in a position to put a stop to babies [like the ones featured in this video] being born with these conditions. By simply stating SSRi use is not recommended in pregnancy is clearly not good enough... they should be banning the use instead of touting the pathetic benefit v risk line. 

I'm left wondering if CEO officials at the MHRA and FDA would place a knife in a crib in the knowledge that there was only a 30% chance that the newborn may roll on to it or if they would leave a candle burning in a child's room if there was a 10% chance of it setting fire to nearby curtains?

A limp-wristed approach will only result in further babies suffering. Putting the onus on doctor's is simply a deflection to avoid personal responsibility.

The regulators are playing with fire.

If you were in a position of power to stop the above, would you?

In 2009 GlaxoSmithKline were found guilty by a verdict of 10 to 2 in a Paxil birth defect trial. The jury found that Paxil, an antidepressant manufactured by GlaxoSmithKline, was the causation of Lyam Kilker being born with heart defects. It was a landmark ruling and a further 800 cases were pending. It is believed that most, if not all of those 800 cases have been settled out-of-court by GlaxoSmithKline, settlements that omitted that GlaxoSmithKline were in any way responsible for the 800 or so babies being born with birth defects.

Evidence produced in the Kilker trial showed that Glaxo officials knew very early on that Paxil could cause birth defects because of its teratogenic effects.

The UK regulator, the MHRA, were sent all court transcripts from the Kilker trial.

They decided not to investigate GlaxoSmithKline.

The MHRA's Head of Licensing, Ian Hudson, was a former employee of GlaxoSmithKline [then SmithKline Beecham], in fact he was the global head of clinical safety. One would have thought the MHRA could have used his knowledge about the dangers of taking Paxil during pregnancy. He's mentioned in the following deposition by Jane Nieman, another former employee of GSK.

The MHRA's proud mission statement on their website reads:

We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe.

Do newborn babies fall under this apparent safeguard?

Other birth defects caused by SSRi use include:

Abdominal Birth Defects / Omphalocele
Autism Spectrum Disorders
Anal atresia (complete or partial closure of the anus)
Cardiac (heart) defects
Cleft lip and cleft palate
Clubfoot (one or both feet turn downward and inward)
Craniosynostosis (skull defect)
Limb Defects
Neural-tube defects (brain and spinal cord, spina bifida)
PPHN (Persistent Pulmonary Hypertension of the Newborn)

For more information visit the Antidepressant & Birth Defects Website HERE




Thursday, April 19, 2012

In Search of Paxil Birth Defect Woman

During the Lyam Kilker Paxil birth defect trial it came to light that GlaxoSmithKline had, in 2001, received correspondence from a woman who was concerned that the termination of her baby after just six months gestation may have been down to the Paxil she was taking.

Doctors had recommended that the unnamed woman abort her child [a boy] after he was diagnosed with Truncus arteriosis, congenital heart disease.

In an email to GlaxoSmithKline she writes:

“I wanted to know if you could direct me to any information you might have of any woman that has taken Paxil and still had healthy babies. My husband and I are ready to try again to get pregnant in the next month or two. I am so nervous. I don’t want to stop taking my miracle pill. But, then again, if there is a chance that this might hurt or affect the baby I want to know upfront. And I will somehow stop taking it for the time being.
 “Please contact me as soon as possible. I love everything this drug has done for me. I am so thankful that your company had this available for me. I just want to continue to have a normal life and have the child that I always wanted. Please contact me as soon as possible.
 “Please don’t forget about me, Thank you.”

The response from Glaxo was typical, inas much as they told her to 'talk to her doctor'.

Meantime, internal documents showed that Glaxo officials were 'almost certain' Paxil had caused her unborn child to develop heart defects. Once again, in typical Glaxo fashion, they kept this to themselves.

Due to legal reasons the woman's name never came to light in the Kilker trial. The only people that know her full name are GlaxoSmithKline.

Internationally respected psychiatrist, psychopharmacologist, scientist, and author, Professor David Healy, is now trying to find this woman.

More about the email she sent to GlaxoSmithKline HERE




Wednesday, April 18, 2012

Glaxo in Yet Another Out-of-Court Settlement

I can't think of any other corporation that have settled so many cases out-of-court than GlaxoSmithKline. Be it Paxil withdrawal cases or Paxil birth defect cases or even Avandia cases, Glaxo are the company that just likes to settle.

Makes one wonder why they actually contest any charges brought against them.

Yesterday they were doing what they do best and settling with Idaho taxpayers for their part in incorrectly reporting drug prices.

SmithKline Beecham Corporation, writes Legal Newsline, doing business as GlaxoSmithKline, will reimburse Idaho taxpayers $2.6 million for Idaho's share of the excessive prices Idaho Medicaid paid for prescription drugs due to the inflated average wholesale prices that were reported.

Part of Glaxo's settlement will reimburse the federal government for its Medicaid overpayments.

GlaxoSmithKline's corporate tagline is...

GlaxoSmithKline helps people to do more, feel better and live longer.

Hmmm, are they talking about themselves or their consumers?

Read more HERE




Big Country - The Kings of Emotion

Most people that know me will know of my love for music. I first got into to Big Country midway through the euphoria of their debut album, The Crossing, Quite fitting then that almost 30 years later I saw them perform this album in its entirety at the Olympia in Dublin last Friday.

I've followed this band for many years, made many friends with their loyal fans and spent numerous nights in Dunfermline, Scotland, the birthplace of Big Country.

Sadly, I missed Big Country in Birmingham this year because of other commitments but being the magnetic force that they are I was compelled to see them perform... and what a performance!

From the opening baseline of Angle Park, a song about a former mental institution in Dunfermline, to the finishing encores of Smokey Robinson's Tracks of my Tears, Neil Young's Rockin' in the Free World and a reprisal of In a Big Country, they had me beaming from ear to ear.

In between they performed the songs from The Crossing and those B-Sides I, as a fan, have been yearning to hear performed live. Balcony and The Crossing were a trip down memory lane, a lane where 12" vinyls were the only way to get the added bonus tracks of ones favourite band.

Other favourites plucked from the vast Big Country catalogue included East of Eden, Look Away, Wonderland, Another Country and the superb Restless Natives.

The band, now fronted by Mike Peters [The Alarm] and duel guitar turnaround of father and son Bruce and Jamie Watson, haven't lost what made them. Their live performances with the dear departed Stuart Adamson were part of my eighties, nineties and noughties upbringing. 2012 and they are still belting out seriously good rock n' roll music and filling venues, such as the Olympia with their electric, nae eclectic, style.

A special shout-out to Jamie Watson, he's had to fill his father's boots on the rhythm section, he's done so with great ease. He is now part of the Big Country furniture and I have nothing but admiration for him.

Even Irish rockers U2 paid homage, leaving the band a note that said "Welcome to Dublin. From the U2'ers" and a crate of Champagne in their dressing room.

If you think Big Country were a one album wonder, you are in a minority - just ask the sellout crowd in Dublin.

Thoroughly enjoyable night. I just hope they continue to flourish and prosper.

Bob Fiddaman

Here's Big Country performing The Crossing.




Tuesday, April 17, 2012

SSRI Completed Suicides

There's been much talk lately as to whether or not there is evidence that SSRi's can actually cause a patient to take their own life. For me, at least, the answer to the question is a no-brainer.

RxISK now has a searchable database where one can research just how many suicides are associated with prescription medication. The information was gathered from the FDA.

Citalopram [Cipramil, Celexa]
1,161 completed suicides.
447 suicide attempts
423 suicidal ideation [thoughts about suicide]

Escitalopram [Lexapro, Cipralex]

841 completed suicides.
472 suicide attempts
623 suicidal ideation

Fluoxetine [Prozac]

919 completed suicides.
457 suicide attempts
540 suicidal ideation

Paroxetine [Paxil, Seroxat, Aropax]

2,273 completed suicides.
1,886 suicide attempts
3,643 suicidal ideation

Sertraline [Zoloft, Lustral]

776 completed suicides.
585 suicide attempts
816 suicidal ideation

Venlafaxine [Effexor] *SNRi

1,117 completed suicides.
797 suicide attempts
1,233 suicidal ideation

The field of psychiatry and medicine regulators, including the FDA, will tell you that the benefits of taking SSRi-type medication outweighs the risks, some psychiatrists actually still deny there are suicidal risks associated with antidepressants. The 'risks' aren't just suicide, suicidal thoughts or attempts. There's a whole host of risks...but they all are apparently outweighed by the benefits.

What exactly are the benefits and how can anything that carries a risk of death be deemed 'beneficial'?

The above figures are just those that have been reported, many go unreported because loved ones left behind don't make the connection partly because the key opinion leaders in the field of psychiatry claim there is no link to antidepressant use and suicide.

Key opinion leaders are just that. They lead the field with their opinions and many doctor's look to their published papers as a useful resource tool before prescribing these drugs.

Reading the statistics above one would feel that it's hard evidence and that it should serve as a stark warning to prescribers. One would think...

RxISK can be found HERE

Monday, April 16, 2012

The Legacy of Shane Clancy

I've been fortunate enough to meet many people since I started writing this blog, sadly most of those I meet have suffered a great loss be it their wife, husband or child.

There can be nothing worse than losing your child particularly when that loss comes out of the blue as a result of suicide. There are no words of comfort I could possibly offer those I have met, I just listen and then, when the time is right, I ask about the life of those tragically taken from loving, caring parents.

I have, in the past, been fortunate to meet with the parents of Sara Carlin, a beautiful teenage girl prescribed Seroxat, an antidepressant that was supposed to help her, one that was supposed to keep her from harm - it didn't...she hanged herself.

This weekend I travelled across the sea to Ireland, the short 45 minute flight from Birmingham took me into Dublin where I was met by the father of Shane Clancy, yet another victim of suicide. Shane was prescribed the antidepressant Cipramil, known as Celexa in the US. 17 days later Shane took his life and the life of another. Shane didn't hang himself, he plunged a knife into his chest 19 times.

Shane's parents, Tony and Leonie, have become great friends over the past two years or so and I felt compelled to spend some time with them and their children. It was a social visit and one that I am so happy I made. Meeting Shane's siblings plummeted me into a world where pain is a daily occurrence, the feeling of loss hit me head on. You see, Shane Clancy wasn't just someones child, he was someones brother.

Leonie, Tony and I ventured out, an Indian curry followed by drinks and socialising with more of Shane's relatives ensued, all had memories of Shane, all told me of this kind-spirited human being who was loved by so many and who, in turn, showed so much love back.

Critics and the pro-antidepressant brigade will argue that his family members are bound to say nice things about him but Shane left a story behind for everyone he met. Restaurant owners, publicans [even though he didn't drink] friends who, like Tony and Leonie, were shell-shocked when they heard the news that such a mild-mannered young man had died in such a brutal manner.

One only has to look at his family home and meet with his brothers and sister to get a sense of how illogical those fatal events were. They make no sense and trying to piece together the reasons why leaves one frustrated and angry.

I am in no doubt that Cipramil turned Shane against all his beliefs. Those moments of madness induced by a drug that is widely prescribed across the UK and Ireland and one that is given a clean bill of health by those limpless wonders who regulate the drugs we all take.

It's a mockery to label a drug an antidepressant when in actual fact it's not anti at all, if it were then Shane's depression [a relationship break-up] would have been magically cured and not magnified. We drink water to quench our thirst, we don't expect it to make us thirsty.

Something is wrong with this world when children and adolescents are given such powerful drugs on prescription. Shane was actually given a month's supply after a short trip to see his doctor. Any person, be they a child or adult, are at risk during the first few weeks of taking an SSRi, to be given 30 days worth of medication was, in my mind, an act of insanity by his prescribing physician.

If a prescription drug is known to cause suicidal thoughts, particularly when first taking it, then why on earth would such a huge amount be prescribed? It leaves me baffled yet understanding the reasons. I understand because I've been involved in this cesspit of pharmaceutical manipulation for the past 6 years, I understand because I took an SSRi, I became suicidal, I became violent, I became a zombie who didn't care much for anything or anyone. It was only when I came off Seroxat [a 22 month withdrawal] that I found myself again. I also understand because I know how this industry works, how they are driven by money and how they will stop at nothing to sell a product to an unsuspecting public, a death here and there matters not a jot, not even in clinical trials.

Doctor's, in the main, believe SSRi type drugs are life savers, nobody under their care would ever die from them...that just doesn't happen on their patch. Well, it does and it did in the case of Shane Clancy.

Now we have a family left behind to pick up the pieces, a unit so strong and united that it overwhelmed me. Shane's family plod along because they have to. They weren't given an option. That's just the way it is and they are expected to deal with it.

On the flip-side we have key opinion leaders from Ireland who claim these drugs do not cause suicide or acts of violence. Their opinions only serve to reinforce the conscience of doctor's who prescribe these types of drugs on a daily basis. It must be safe because so and so said so.

My time with Shane's family and friends in Ireland was enjoyable yet tinged with sadness. I enjoyed the company... I would have enjoyed it so much more if Shane were there.

Ar dheis Dé go raibh a anam

Leonie and Tony - I salute you.

Leonie Fennell's blog can be found HERE.




Sunday, April 15, 2012

The Times They Are Changing...

...or not, as the Casey may be.

Irish Times Columnist and Psychiatrist, Patricia Casey

On Saturday 14th April the Irish Times published an extremely well written account regarding the use of antidepressants. The article, entitled, 'Bitter pills to swallow', should have created much debate, alas the powers that be at Ireland's best selling newspaper seem to cherry pick comments for approval.

The account itself was an unusual step for the Irish Times particularly as it threw up the question that many people have been asking for some time now. Do antidepressants really work? Regulary quoted by the Irish Times, Patricia Casey, seems to have all the answers and, it appears, is wrapped in cotton wool by the Irish Times staff.

I left a comment at the end of 'Bitter pills to swallow', sadly the moderators didn't allow it through. Maybe the mention of Patricia Casey raised a red flag. It seems that anytime an opinion is offered about Casey she threatens with a warning letter from her solicitors. The Irish Times have, in the past, fallen foul of Casey's iron fist. They had dared to allow a comment through that had criticised Ireland's darling of psychiatry, a comment that, apparently sent Casey running to her solicitors threatening the newspaper with legal action. Their apology to Casey came in August 2010 where they wrote:

On May 23rd, a comment related to this article was moderated and published by The Irish Times on its website in the “have your say” section. The comment concerned Professor Patricia Casey. The allegations published in the comment were without foundation and were seriously defamatory of Professor Casey and have caused her great personal hurt and distress. The Irish Times accepts that Professor Casey is an internationally-respected psychiatrist of the highest standing and reputation.

The content of the offending comment is unknown, as is the level of 'personal hurt and distress' it casued Casey. How would one measure levels of personal hurt and distress anyhow? Maybe the same way the field of psychiatry magically measure levels of serotonin in the brain's of their patients?

This isn't the first time Casey has ran to the protection of law firms. Last year Casey didn't like what she saw on Leonie Fennell's blog - Fennell, whose son, Shane, suicided after 17 days on Cipramil [citalopram] had wrote a piece involving a statement from another woman that prompted Casey to turn to her legal team. The opening paragraph of the letter from Brophy Solicitor's reads: "Our client has instructed us in relation to comments appearing on your internet blog in which you repeat a statement that another lady made to you that “Patricia Casey ruined my son’s life”.

I can only assume that my comment left yesterday was deemed inappropriate because I mentioned Casey's name. The Times, it appears, wouldn't dare allow a comment through that mentioned Casey - why would they want to go through the legal battlefield again?

It appears that many folk are frightened by Casey, I've spoken to one such person this week, he wishes to remain anonymous, sufficed to say he didn't speak too favourably of her.

Casey, like me, is opinionated. Where she believes that antidepressants cannot cause suicide, I, on the other hand, think the complete opposite. Where she claims there is no evidence that supports the antidepressant/suicide link, I, once again have an opposing view to hers. Quite why Casey believes there is no suicide link is a mystery given that the manufacturers of these drugs have admitted that there are suicide events associated with their products.

Casey, like me, is entitled to her opinions. She's wrong on the antidepressant/suicide link though, so very wrong.

My comment is below. I think it's fair and balanced. Casey, can use the comment section on this blog if she wishes to respond. Any move toward solicitor's offices will be seen, by me at least, as being rather churlish.

An extremely good article, not before time too.

The mainstream press seem to tow the pharmaceutical company line when reporting on antidepressant drugs due, in part, to being cautious as any negative reporting of SSRi type drugs may make those on them abruptly stop taking them.

The industry along with medicine regulators and healthcare professionals claim that the "benefits outweigh the risks" - What are the benefits? Do these drugs actually cure anything or do they merely paper over the cracks?

SSRi's are not just handed out for depression or anxiety - the marketing genius of pharma has branched out and now we see these drugs prescribed for all sorts of human emotion.

It's not okay to feel blue anymore because we are told feeling blue is a mental disorder, it's become as common as a sore throat and runny nose, one only has to look at the prescribing statistics to see this.

We have regulators in place to safeguard human health but are they really doing so? What do they actually do with the thousands of adverse events sent to them by patients and doctor's? Do they follow-up by visiting the GP or patient or do they just add the report to their bulging database of adverse events? We know the answer to this already, right?

Key opinion leaders have a huge part to play too. Those who oppose the over medicating of normality are rarely given their own newspaper columns where those who are pro-antidepressant are given weekly columns promoting the use of these drugs, it's advertising by proxy and really should be regulated.

Case in point being Irish psychiatrist, Patricia Casey, who is often quoted in The Irish Times where she speaks about the dangers of various mental illnesses and various 'fixes'. I don't see the Irish Times offering the same column inches to those who oppose her views.

In essence Casey's musings come without the black box warning or patient information leaflets, they are sugar-coated, unbalanced and all based without any scientific data.

What surprises me most about this is that the Irish Times always strive to report on the facts, they have to for fear of being dragged through the courts on a defamation charge. The reporting has to be accurate and backed up with evidence. It's the Editor's mantra but one that, it appears, does not apply to the thoughts and scribblings of an influential psychiatrist in Patricia Casey.

Carl O'Brien has offered readers a superb balanced argument in this article, one that is worthy of debate. The Irish Times should give themselves a huge pat on the back and maybe offer regular column inches to those who have a different opinion to that of Casey, what have they to lose by offering a different opinion?




Wednesday, April 11, 2012

GSK, Not So Corporate


Back Story

Read more in my book, links below.




Thursday, April 05, 2012

Ask Alfie Birmingham

I love people that have the gumption to get out there, I love people who have dreams and strive to make those dreams a reality, I love people who flourish, who have such a unique talent and recognise that they have that talent.

Ask Alfie, are a band from my hometown of Birmingham, UK. Their genre is unique, it's not pop, it's not rock, it's not hip hop - it's a combination of all three, a refreshing sound from a hard working band who are making waves across Birmingham's music circuit.

So, why is a pharmaceutical/regulator activist writing about an unknown bunch of musicians from Birmingham?

Two reasons:

1. They're bloody good


2. My nephew formed the band

He's a hard working kid, a family man, a talented lyricist.

Hey, maybe I'm biased but I have always had a love for music, from hard rock to classical. When I hear something that pleases the ear I like to tell people about it.

Ask Alfie have played the O2 Academy in Birmingham twice now, they are expected to headline their next gig there.

They are prospering but they need guidance, they need a manager to take them to that next level.

Who needs Britain's Got Talent when there are so many hard-working bands playing the local circuits every night across all the major cities in the UK?

Ask Alfie are one of those bands.

Two tracks below are:

Awkward Love and Karaoke.

Follow Ask Alfie on Twitter

Ask Alfie Website




Wednesday, April 04, 2012

Pharmageddon – David Healy

I was fortunate enough to receive an advanced copy of Dr David Healy's new book, Pharmageddon. It's taken me a while to read it due to other commitments.

Here's my review.

Pharmageddon – David Healy - University of California Press 2012

Pharmageddon is a meticulous look at the inside workings of the pharmaceutical industry and the way in which prescription drugs are marketed throughout the world and how this aids in the survival of some of the most richest and influential global organisations in the world today.

Dr David Healy, a Professor of Psychiatry at Cardiff University and the author of many publications, has painstakingly chartered the history of pharmaceutical wares and shows, in many instances, how ‘evidence-based’ medicines aren’t really evidence based at all. In fact, quite the contrary.

Clinical trials that were initially designed to find faults in a product have found their way into a world where time (and money) is of the essence and where trials carried out today appear to put the onus on the patient to report any faults in the product...after it has been granted a licence by the regulatory bodies...sometimes many years after its release into the market.

Medical journals, in which prescription drugs are often promoted as being safe and effective, have also played a huge role in the prescribing of drugs, that are, in many instances, not safe or effective at all.

Healy explains why this is so in a carefully crafted and extensively researched book that throws light on the internal misgivings of a complex industry where kickbacks and ghostwritten material are commonplace.

His walk through history and to present will leave the reader, be they professional or patient, in no doubt that Pharmageddon is just around the corner and we are, indeed, in our end days of pharmaceutical control and manipulation.

Pharmageddon is not a critique of the pharmaceutical per se but it does show how the dollar has become the main objective opposed to helping a patient battle an illness with drugs that, on many occasions, make the illness worse or, indeed, create a new illness for patients to deal with.

Many side effects to prescription drugs go unreported, more often than not those side effects are seen by healthcare professionals as a need to prescribe more drugs because they fail to see that the medications are actually making matters worse. Moreover, these same healthcare professionals are visited by pharmaceutical reps who, after leaving free gifts, tell them that their drugs are better than others, proving efficacy by pointing to opinions given by respected thought leaders that have published papers in medical journals showing how safe and effective the drug is.

It’s a marketing strategy played out to perfection by an industry whose promotional tools include marketing an illness before the product, to reel in prospective buyers of a future product.

The launch of Pharmageddon comes on top of Healy’s new website, RxISK, a domain that offers a reporting system for patients and doctors to report adverse reactions caused by a myriad of pharmaceutical products.

It is only by reading Healy’s book and using reporting systems such as Rxisk that the wheels of Pharmageddon can grind to a halt and that the concept of treating patients can return to the days of patient care rather than pharmaceutical profit.

Pharmageddon can be ordered via Amazon UK here or direct from the University of California Press, here.




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