Masterfully Harming Kids for Profit

eu·phe·mism (noun)

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

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

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

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

Spin Doctors At Work

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

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

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

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

Baum Hedlund states:

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

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

Wreckless Endangerment of Children

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

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

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

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

Bob Fiddaman

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

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/

--

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/

--

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.

Letters from Generation Rx - A Review

**Update April 7
The movie is now available to watch - see trailer at the foot of this review.

I was fortunate enough to be sent an advanced copy of Kevin P. Miller's groundbreaking new movie, Letters from Generation Rx, earlier this week. I pretty much knew that it would sadden me. I pretty much knew that it would, at the same time, make me angry. I wasn't wrong.

Award Winning Film-Maker, Kevin P. Miller

Kevin P. Miller has created something quite beautiful with his latest offering, beautiful yet tragic.

From the opening reel we are shown a woman driving her car with her children in the back passenger seats - the scenery is stunning, the whole cinematic event being a reconstruction, one in which the stunning scenery pales into insignificance when we realise that this is no opening scene about the beautiful countryside or, indeed, about a mother taking her children out for a ride to educate them about their surroundings.

From here we are taken on a journey, the driver, Kevin P. Miller, is an award-winning film-maker and he takes us carefully through a minefield of information and disinformation courtesy of global medicine regulators and pharmaceutical companies. The narration is provided throughout by Oscar winner Tilda Swinton. We, through Miller's careful navigation, are driven through the stench of the lies and deceit, along the way we meet the victims of those lies and deceit. We stop, look and listen to their stories, all sounding familiar, all with one common denominator. Selective Serotonin Reuptake Inhibitors (SSRIs)

I've met a good number of the victims in this movie, I wish I hadn't. Our paths crossed because they had lost someone loved to SSRI induced suicide. I have spoken with many more of the subjects featured in Miller's two hour long documentary - hearing their stories again doesn't make it any easier for me to hold back the tears, the anger.

This is a movie that those of us who choose not to read about children, teens and adults killing themselves will, no doubt, turn a blind eye to. "I know it goes on but it's too upsetting to read", are just some of the comments I have heard about the articles that I write. Sorry folks but that just isn't good enough.

Every one of us has a duty to protect the most vulnerable, just ask the parents, partners, featured in Letters from Generation Rx why they advocate for better regulations of prescription medications. Everyone of them have, since the death of their loved ones, made remarkable strides in creating an awareness about the dangers of drugs such as Zoloft, Paxil, Prozac, Lexapro, to name but a few.

Letters from Generation Rx shows us the human side of devastation, it also shows us the inhumane side of the pharmaceutical industry and global medicine regulators. It's jaw-dropping when we are shown by Miller how many of the regulators have vested interests at heart opposed to what they were put into place for - protecting public health.

The relationship between global medicine regulators and the pharmaceutical industry is incestuous and one that is based purely on profit margins.

Miller's movie will have you reaching for the pause button so you can compose yourself after each story is driven home, it did me anyhow.

I doubt if the findings in Letters from Generation Rx will bother the likes of pharmaceutical CEO's or any of the limp-wristed medicine regulatory authorities around the world. They have become too corrupt, too greedy - their hearts have been blackened as they all sit in their ivory towers counting the dollars whilst dismissing the death and destruction that paved way for those dollars.

The movie is harrowing, to say the least. One story is bad enough to endure but to assemble a bunch of stories and to craft them into a two-hour documentary is something that Kevin P. Miller should be applauded for.

To add further incestuous ties to pharma and the medicine regulators the movie shows how Health Canada saw fit to go after one of the victims featured... all because he came up with a healthy nutritional supplementation program after his wife died and two of his ten children later struggled to cope with the loss of their mother. TrueHope, became the target of Health Canada who tried to stop them selling and distributing EMPowerplus to the thousands of participants in the Truehope program in Canada. You'll have to watch the movie to find out the outcome.

Kevin P. Miller has, through his craftsmanship, created something that we should all be queuing to buy and then, once we've all watched and condensed it, we should all be busting a gut to make sure that we don't take this pharmafia abuse lying down anymore.

Letters from Generation Rx is essential viewing and is set for general release in the coming weeks.

Here's a teaser...

Bob Fiddaman.



Official Website for Letters from Generation Rx (Currently being updated)

Letters from Generation Rx Official Facebook Page

Recent Interview with Kevin P. Miller

Elizabeth Kenny, Caught in the System

Every now and again, in life, you stumble across something that is beautiful, sad and, at the same time, profound. Sometimes, you read or hear something that makes you shout out in total agreement, particularly if that something is the very same something that you have been saying for many years.

Elizabeth Kenny - Thank you

Elizabeth Kenny is an actor, writer and activist. She is also someone that could, just possibly, save many from a life time of psychiatric drugs. Her one-woman show, 'Sick', is a true story of misdiagnosis and medication.

At 32, Elizabeth went to see her doctor because she had developed ovarian cysts. 18 months later she was spending time with level 5 patients from the psych ward where she had been admitted to.

'Sick', written by Elizabeth, in collaboration with John Kazanjian, ran for three months and sold out night after night at the  New City Theater in Seattle. There's a trailer for 'Sick' after the first video I wish to show you.

In this first video, Elizabeth talks to an audience about her experience at the hands of a psychiatrist and her subsequent journey and introduction to psychiatric drugs, namely Paxil, Celexa, Zyprexa and Lexapro.

Her delivery will captivate you and many regular readers of this blog will be, like I was, shouting in total agreement at what Elizabeth has to say.

Elizabeth Kenny, I salute you.

And here's the trailer for her one-woman show, 'Sick.'

Elizabeth's website can be found here.

Bob Fiddaman.

Celexa and Lexapro Refunds

A federal judge has ruled that parents, whose children were prescribed the antidepressants Celexa [citalopram] and/or Lexapro [escitalopram] are entitled to refunds.

Forest Laboratories and its subsidiary Forest Pharmaceuticals, have agreed to shell out up to $10.4 million in refunds.

Back in 2010 Forest  pleaded guilty to federal charges that its sales force team illegally marketed Celexa and Lexapro for use in children and teenagers when they knew that both drugs were only approved by the FDA to treat depression in adults. According to the charges, Forest bribed doctors with cash, meals and travel in efforts to persuade doctors to prescribe the drugs to children.

Why aren't we surprised by this anymore?

Once again we are seeing a pharmaceutical company quietly settle matters, once again there is no jail time for any of the executives, once again money is thrown at the problem.

The 2010 charges also allege that Forest covered up the negative results of their pediatric trials.

So they knew their drugs were no better than placebo yet still targeted doctors to prescribe them to kids.

Anyone familiar with the story Hansel and Gretel?

Dr. Greg Mattingly with his wife Judi

Dr. Greg Mattingly, a psychiatrist in St. Charles, was also named in court documents as one of the country’s top prescribers of Celexa. Evidence shows notes made from a phone call with Mattingly and a Forest sales representative where he agreed to include information about Celexa for children into his talks. Mattingly is alleged to have received more than $107,000 from Forest Pharmaceuticals in meals, travel and speaking fees in 2012 and close to $38,000 in 2013, according to trial documents.

Dr. Brian D. Barash

Dr. Brian Barash, a Kansas City psychiatrist and chief medical officer of the Marillac Children’s Psychiatric Treatment Center, was paid “thousands of dollars to give dozens of speeches to Missouri doctors about Celexa,” according to trial docuuments.

Take a good look at the photos above. Both have, it seems, been promoting drugs that not only don't work in children but drugs that are dangerous for children.

Forest has already agreed to pay out $313 million to settle allegations with the government and millions more in dozens of personal injury lawsuits.

• 13-year-old Andrew Tradd of Massachusetts, who died of a brain injury days after he tried to hang himself in 2004, two years after being prescribed Celexa. 
• The family of Danielle Henrikson, 15, sued the company after she hanged herself in her Idaho home the same year, weeks after starting the drug. 
• Alex Kim of Georgia, hanged himself in 2004 after his dosage of Lexapro was doubled.

Full article, 'Parents can get refunds for some anti-depressant drugs given to kids', here.

Celexa is known in the UK as Cipramil. Lexapro uses the brand name Cipralex in the UK.

Both drugs are also under scrutiny for causing birth defects.

More on the settlement agreement here.

Bob Fiddaman.

Forest Illegally Promoting Antidepressants For Kids!

Forest Pharmaceuticals, Inc. and Forest Laboratories, Inc. have been up to no good. Yet another pharmaceutical company who have, according to a new lawsuit, been holding back information concerning the effectiveness of two company drugs for the treatment of depression in pediatric patients. Those two drugs being the antidepressants Celexa and Lexapro.

Naughty, naughty.

The lawsuit, filed by two mothers from Missouri who are being represented by Baum, Hedlund, Aristei & Goldman, PC and Pendley, Baudin & Coffin LLP, claims that "Forest marketed antidepressants Celexa (citalopram) and Lexapro (escitalopram) as effective for use in pediatric patients, even though studies showed evidence to the contrary".

The plaintiffs, Ruth Dunham and Tanya Shippy, allege "Forest deprived consumers of the ability to make an informed decision about whether to purchase or prescribe Celexa or Lexapro for their children by withholding information about the negative efficacy studies and engaging in an aggressive marketing campaign designed to mislead consumers and physicians".

A pharmaceutical company aggressively marketing drugs for kids when they knew the drugs weren't effective in kids?

Surely not, I mean stuff like this just doesn't happen, right?

U.S. District Judge Nathaniel M. Gorton of Massachusetts stated in his ruling that the allegations are viable under the Missouri Merchandising Practices Act (MMPA). The MMPA prohibits “deception, fraud, false pretense, false promise, misrepresentation, unfair practice or the concealment, suppression, or omission of any material fact in connection with the sale or advertisement of any merchandise in trade or commerce.”

Be interesting to see how this one goes. Forest will be up against it.

Baum Hedlund have represented more than 4,000 individuals across the US in personal injury and wrongful death cases involving harmful medications. They spanked those other pediatric suppressors, GlaxoSmithKline, on more than one occasion.

Celexa and Lexapro are antidepressants in the SSRi class, they work pretty much in the same way. Some believe [myself included] that Lexapro only ever came about because the patent for Celexa was running out. Change a molecule here and there, change the name, submit to the FDA and...VOILA...a new drug hits the market that does exactly the same as the older drug... in this instance does nothing, apart from causing suicidal ideation and self harm for pediatrics who take it!

Why promote anything that doesn't work? Moreover, why promote something that is dangerous for pediatrics?

Forest have, it appears, taken a leaf out of GSK's book here. Who can forget the Paxil 329 debacle?

Be interesting to see if any evidence comes out of this trial that shows yet more ghostwriting shenanigans or if Forest's reps were just as adamant as Glaxo reps to "get the sale" at whatever cost.

Grown men and women playing with children's lives. Don't you just love the pharmaceutical industry!

The full press release can be read on the Baum Hedlund website HERE.

Bob Fiddaman

A Message From RxISK

Have you developed visual problems on anti-depressants, or when stopping them? RxISK.org are looking for those that have.

http://wp.rxisk.org/keeping-an-eye-on-the-ball-visual-problems-on-ssris/

Although the person in the article lists a number of visual symptoms, it is worth noting that their main problem is blurred vision and poor night-vision.

If you experience these problems, please get in touch.

We're very keen to hear from SSRI users, but we would also be happy to hear from other anti-depressant users. You don't have to be based in the UK, providing you can arrange the same testing.

We need to get this message out to as many anti-depressant users as possible. Please help us to spread the word.

Many thanks.

James Bennett (assisting RxISK.org)

School Shootings and Other Bizarre Incidents

Bob Fiddaman

SSRi Withdrawal - A Lesson For Doctors

Far be it from me, a blogger, to give doctors a lesson in managing antidepressant withdrawal... but I'm going to anyway.

I've been writing this blog for 8 years now and, over this period of time, have been inundated with emails from patients struggling with withdrawal issues from their medication. Most popular question is along the lines of "How long does it take before these terrible side-effects go away?"

A good 90% of the emails start off by telling me the side effects, crying, sweating, electric-like zaps in the head, shaking, most of these conditions, if not all, appear when the patient starts to taper off the drug on the advice given by their healthcare 'professional'.



When I have told those who have contacted me about their medication being available in a liquid form they are flabbergasted. Why didn't my doctor tell me this? is the normal reply.

The liquid formulation for SSRi type medication came about as a result of pharmaceutical companies being able to persuade doctors [via their reps] that patients who had difficulty in swallowing their medication could always use the liquid. These 'patients' were the elderly and children. The liquid was never intended to be used as an aid to help people wean off the medication.

Wait a minute, these medicines aren't meant for children. Correct, but that has never stopped the pharmaceutical industry reps in their quest to boost company sales in return for that big bonus at the end of each month or quarter.

So, what about adults who have no trouble swallowing tablets? Well, the gist I'm getting from the emails I've received is that doctors tend to read the company spin on withdrawal.

Pharmaceutical companies never liked the word 'withdrawal' as it implied giving the patient a hard time so they changed it to 'discontinuation'. Doctor's when reading the product monograph for any of the SSRi's will read that 'discontinuation syndrome should only occur for around two weeks'. There is no information given to the doctor or patient about how much he/she should reduce their dosage by.

Contact the manufacturer of your particular SSRi and you are taken on a frustrating journey.

Pharmaceutical companies will tell you that they are not allowed to discuss individual patient cases and will refer you back to your healthcare professional, who remember has at his disposal the product monograph that claims 'discontinuation should only last around two weeks'.

Truth of the matter is, discontinuation/withdrawal can last months even years. Your healthcare professional won't acknowledge this because all he has to go on is what the pharmaceutical company have provided him [product monograph]

Some of the advice given by doctors that I've seen personally has ranged from the ridiculous to the sublime. Here's some:

• Cut your tablet in half
• Take 20mg Monday, 10mg Tuesday, 5mg Wednesday then stop.
• Try stopping altogether at the weekend as there will be less stress in your life, ie; work, dropping the kids to school. If you still feel bad then start again on Monday.

One patient, a 17 year old, was told by his trainee psychiatrist, to stop taking his Prozac at weekends so he could enjoy up to six bottles of beer then restart again after the weekend. That patient, Toran Henry, killed himself shortly after being prescribed a generic form of Prozac [Fluox]

So, where can doctor's go for their information on antidepressant reduction?

Product Monograph [Written by the manufacturers of the drug]
Patient Information Leaflet [Written by the manufacturers of the drug]
Medicines Regulator [A body fully funded by the pharmaceutical industry]

Where do patients go?

Well, they go to the one person they can trust, their doctor. It may take a while for the patient to realise that the doctor is as clueless as they are when it comes to withdrawal help, it's then that they turn to either friends or, more commonly these days, Google.

Many patients find themselves using search terms such as 'Escitalopram aggression', 'Seroxat Brain Zaps', 'Cipramil Agitation'. The hits, when I first started this blog, were few and far between. That's when I learned that Seroxat isn't called Seroxat in the USA, it's called Paxil. Back then I Googled the words 'Paxil + Withdrawal' - I hit the jackpot. Website after website, forum after forum appeared. Stories about brain-like zaps, aggression, suicidal thinking, self-harming. The same can be said today for Cipramil and Escitalopram [both brand names for drugs known in the US as 'Celexa' and 'Lexapro' - Try a Google search yourself and you will see much more can be learned by typing in the US brand names opposed to the British/European brand names.

Even if you do find evidence that you are not alone in this withdrawal hell don't expect your healthcare professional to thank you for bringing the evidence to his/her attention. More than likely you'll be told that it was he/she who went through med school, if he/she does tell you this then ask him/her how long he spent covering SSRi withdrawal.

He/she may also tell you not to do your own research as you are either not qualified in such matters or the information on the internet about SSRi's is just conspiracy theories.

What you, as a patient, must do is TELL your doctor that you need a liquid version of your antidepressant so you can taper safely and effectively. Remember, this is YOUR body.

Tapering by using the liquid is a very slow process but it is much safer than skipping doses or drastic reductions in dosage.

You may find the taste somewhat off-putting, Glaxo's Seroxat liquid is orange flavoured and tastes like 5 cups of sugar has been added. If you can get through the bad taste then it's better than having to endure mind-bending electric jolts through your head.

Apparently the liquid formulations of SSRi's cost more, probably one of the main reasons doctors won't write scripts for them.

Remember that SSRi withdrawal is your own experience, it does not belong to your doctor or anyone else for that matter. Don't frustrate yourself because the manufacturers of your medication won't help you - that's just their way of avoiding litigation. If they acknowledge you are having a bad time on their drug then they'd have to acknowledge that other people are too - that would just open the door and they'd be flooded with personal injury lawsuits.

So, how slow do you taper once you have the liquid? As slow as you need to is the answer. I came down 0.5mg per week. [20mg dose of Seroxat = 10ml of Seroxat liquid] It took me over a year to drop from 40mg per day to 22mg per day. I then quit cold turkey - not recommended.

So, if you are a healthcare professional using Google and you have stumbled on this post then I suggest you put your BNF to one side, disregard all the pharmaceutical propaganda you have at hand, take off your God hat and start listening to patients.

The pharmaceutical industry will get richer from you, the patient, snapping up their sickly, foul-tasting liquid but at least you will be reducing the money going in their pocket. What's it to be, a slow taper or a life-time hooked on SSRi's?

At the time of writing this I'm only aware of four SSRi's that are available in liquid. Namely, Fluoxetine, Sertraline, Paroxetine and Citalopram .








Bob Fiddaman

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Celexa/Lexapro... Or Your Money Back

Not for use in children and adolescents

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

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

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

How do we know this for sure?




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

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

We know how that works, right?

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

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

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

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

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

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

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

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

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

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

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

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

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

1. They should be held accountable.

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

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

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

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

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

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

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


Bob Fiddaman

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Health Canada Under Fire

Health Canada, the "independent" body of regulators who monitor the safety of drugs, have recently come under fire for failing to monitor the safety of drugs dished out to millions of Canadians every year.

I've highlighted Health Canada many times on this blog. They, just like other global medicine regulators, are about as useful as a waterproof teabag when it comes to safeguarding the public.

Yesterday The Star ran with the headline, 'Health Canada brushes off reports of serious side effects'. The article, written by David Bruser and Jesse McLean, heavily featured the story of Brennan McCartney, the 18 year old who killed himself just 4 days after being prescribed the powerful SSRi Lexapro [known as Cipralex in Canada] - Back story here.

Like many before her, Brennan's mother, Nancy, was shocked to find that the medication given to her son could actually induce suicide. This was learned after the event because the warnings about this adverse reaction are seen as a minor risk by Health Canada.

Lexapro - The Brennan McCartney Story

Brennan McCartney - A victim of Lexapro

You are young, you have relationship problems with your partner, you talk things through with your doctor, you are prescribed a drug, that drug is not recommended for people of your age group.

You kill yourself.

An all too familiar story has recently been aired on Canadian TV.

Brennan McCartney was just 18 years old when in November 2010, he was prescribed Lexapro [known as Cipralex in Canada]. 4 days later Brennan hanged himself.

Lexapro is the sister drug to Lundbeck's earlier antidepressant Celexa [also known as Cipramil]

Now, this is where pharmaceutical marketing comes into play.

Celexa's patent was running out, in other words, other companies could make generic versions of it, thus making heaps of money... money that Lundbeck wished to keep for themselves.

So, what do they do?

They play around with a molecule or two of Celexa then re-badge it as Lexapro. Voila! A new antidepressant hits the market.

The company hail it as a much better drug than their previous best-seller. Doctor's, convinced by pharmaceutical spin and ghostwritten articles start switching patients from one drug to another which is, in essence, the same drug.

Canadian Brennan McCartney was prescribed a sample pack of Lexapro, a pack that would have been left behind by a visiting Lundbeck rep who more than likely would have failed to mention the suicide link in Brennan's age group. The rep would not have cared who the doctor was prescribing it to, nor would he have intervened if the doctor was prescribing off-label to patients that the drug was not recommended for.

Brennan's doctor may or may not have told the 18 year old about the dangers of taking Lexapro, particularly during the first two weeks. Even if he did, Brennan really wouldn't have believed that a pill manufactured to help lift his apparent depression could actually make him worse.

SSRi's such as Lexapro make you do things that you wouldn't normally do. You lose your inhibitions, you lose your fear, two traits that are embedded in us for a reason. They tell us what is right and what is wrong, they are pre-cursors... warnings, insights into consequences.

Brennan was contemplating a split with his partner. He, like millions of others, was trying to deal with the heart-ache. His doctor, for reasons that I am unaware of, deemed Lexapro as a pill to help heal his heart, a heart, that remember, was broken...only metaphorically speaking.

Instead of healing the gut-wrenching feeling of a relationship split, Lexapro managed to do the complete opposite. It fixed nothing. The chemicals released into Brennan's system would have more than likely been the cause of his chemical imbalance - they would have changed because Lexapro gives you a re-uptake of serotonin - the substance, claim doctor's, psychiatrists and pharmaceutical companies, that needs boosting when one becomes depressed.

This, as many of you know, is pseudo-science, it's claptrap, it's pharmaceutical spin designed only to sell more and more drugs to an unsuspecting public.

Man in white coat treats poorly patient - man in white coat is deemed as God.

There is no better retailer for a product.

So, what happens when a patient commits suicide when taking one of these types of drugs?

We've all seen the warnings that they 'may' cause suicide...yet when they actually do cause a person to take their own life we get no admittance of liability from the companies that make them. The victim...or rather the victim's original illness is blamed, in Brennan's case, heartache.

Brennan's parents have called for toxicology reports to be carried out on their dead son. Those wonderful folk at the Coroner's Office in Brampton, Ontario have denied their request citing, "the results would be inconclusive"

Genetic testing could determine if Brennan was in a susceptible population, there are certain folk who metabolize these drugs better than others. By not allowing Brennan's parents this one simple test the Coroner's Office of Brampton, Ontario are failing to protect the public, they are sweeping a young death under the carpet because any result from a toxicology report that raised a red-flag to this particular patient population would have to be tackled and Coroner's just don't want to get involved in something so irrelevant.

The Coroner's Office in Brampton should be utterly ashamed of themselves. Quite how they arrived at such a decision is baffling...to say the least

Brennan became agitated, so much so that he told his parents that he 'had to get out'. Brennan left the family home - he never returned again.

It's plainly obvious, to me at least, that Brennan's agitation was a result of ingesting Lexapro...as was his suicidal act.

Brennan McCartney was not depressed, he was saddened because that's how people with a heart get when they split with partners.

Lundbeck, the manufacturers of Lexapro, will no doubt use that in a defence - they will use the fact that Lexapro was not indicated for someone with sadness, particularly someone who fell into the age-group of Brennan. They don't mind doctor's prescribing it though!

So, another kid dies because he was prescribed a drug 'off-label', a doctor who was given carte blanche by medicine regulators who stubbornly refuse to ban SSRi use in children and adolescents. Not recommending use of a drug is not the same as banning it. It's a limp-wristed gesture to show the public that the regulator, in this instance Health Canada, are doing their job correctly.

The segment [below] was aired on 16x9. In it, Lundbeck are quoted as saying that 'there is no evidence that the drug increases the risk of suicide'

According to the FDA, the American drugs regulator, Lexapro was given a black box warning because it indicated that it can cause serious side effects, including disabling reactions, life-threatening conditions or fatal results.

So, suicide isn't a fatal result then?

And what of an inquest for Brennan McCartney?

Well, we've seen just how utterly useless Coroner's courts can be in the past. Two in Canada spring to mind:

Vanessa Young [Prepulsid] and Sara Carlin [Paxil]

In both cases recommendations were made. None of the recommendations made have ever been implemented.

It's ironic that the word 'recommendations' is used twice here. Not recommended for children and adolescents and recommended that A,B or C be carried out to protect future patients.

The word 'recommendations' means nothing, it's yet another smokescreen to make it look like something will eventually be done about a problem...when in actual fact there is no intention to do anything about a particular problem.

The segment about Brennan's suicide can be seen from 7.14 onwards.




Brennan's mom, Nancy, can be followed on Twitter - @NancyMcCartney2

SSRi Benefit v Risk v Suicide

SSRi medication.

Endorsed by the regulators.

Manufactured, marketed and promoted by the pharmaceutical industry.

So, what are the benefits and exactly who is responsible for those that have tragically lost their lives?

Fid

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

AUSTRALIAN ORDERS HERE

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

The Shane Clancy Case: Celexa Induced Homicide/Suicide

22 Year Old Shane Clancy

Three striking articles to report on today, two from the Irish Examiner and one from the pen of SSRi withdrawal expert Prof. David Healy.

Each discusses the case of Shane Clancy, a young man from Ireland who, after digesting a large amount of Celexa, killed a young man before stabbing himself in the chest 19 times, resulting in his death.

At first glance the Clancy case seems open and shut. Young man breaks up with girlfriend, realises his mistake, tries to reconcile relationship, learns his former girlfriend is seeing someone else, kills 'someone else' in fit of rage.

You'd be hard put to find any kind of supporting evidence for the Clancy family... unless you knew about the way SSRi's such as Celexa work on young minds.

Delving deep into the history of Shane Clancy and you will learn that he was just your normal run of the mill young man. At 22 he was furthering his education at Dublin college, after his relationship breakdown he travelled to the far-east and Australia but returned early to try and reconcile.

Seemingly feeling the effects of a broken heart Shane was prescribed Celexa, [known as Cipramil in Europe] manufactured by Lundbeck [Forest Pharmaceuticals in the US]. Around three weeks later Shane was dead as was another young man, Sebastian Creane.

I found it difficult to write about this case when news first broke. I toyed with the idea that I would be upsetting the family of the victim. It was after some soul-searching that I realised that both young men were the victim and any one who doubts that need to see how Celexa use has been tied in with many suicidal acts in children and young adults.

The same story comes out almost every time...'just your average teen with no prior thoughts of suicide...'

It's safe to say that I may show a bias in my reporting of the Clancy case. I've met both Tony and Leonie [Shane's parents] and, as timing would have it, am meeting them again next month.

Ironically, it's almost 12 months ago that I interviewed Leonie Fennell in a special podcast for this blog, an interview that is hard hitting and one that I found difficult to play back and listen to once completed. The interview is below and lasts for about an hour.

There are those who sit on the side of the fence and say that parents will always try to blame anyone but their children for acts of homicide, these same people will also blame anything else but the medication the child was on. It's hard to argue against their stance until you see other cases of suicide on these drugs. One such case would be that of Matthew Steubing, an American teenager who, after being prescribed a course of antidepressants [Lexapro] jumped from a bridge and killed himself. He was just 18. Lexapro is the sister drug to Celexa and was heavily promoted to be safe and effective in the treatment of depression. Despite it not being recommended for children and adolescents, healthcare professionals were still allowed to prescribe it.

Just like many of the SSRi drugs out there today are not meant for this age group, they are still being prescribed. The pharmaceutical companies, who have studied the use of these drugs in children, don't speak out against doctor's prescribing them because it makes them lots of money. The regulator's sit and shrug their shoulders and claim that they have sent out warnings to healthcare professionals - that one simple act clears their conscience that they are doing the right thing and protecting this vulnerable population. It;'s akin to giving a small child a box of matches with a warning that they will harm if used incorrectly.

Shane Clancy should never have been prescribed Celexa. His prescribing doctor weighed up the benefits versus the risks. The benefits are what he/she would have been told by the travelling salesman [Lundbeck rep] and what published studies he/she may have read about Celexa in adolescent use, studies written by Lundbeck and Forest's handpicked key opinion leaders...any of the negative studies about Celexa would not have been made public, assuming that there were negative studies.

Pharmaceutical companies are in business to make money, they are not in the business to make you and I feel better - that would be corporate suicide. They want you to take their drugs for a lifetime and if you don't have any illness that fits then they just simply invent one or two disorders by proxy [DSM].

It's a licence to print money.

It's a licence to kill.

Here's the interview I did with Shane's mom last year.

Related Links

Professional suicide – the Clancy case - David Healy

Shane Clancy Blog

Irish Examiner

‘Too many’ suicides linked to depression tablets

Anti-depressant drugs - Investigate claimed link to suicides

SSRi Birth Defects

An article in today's Daily Mail confirms what's been known for some time, at least by those in the know. The British drug regulator, the MHRA, seem to be ignorant on this matter or just prefer to bury their heads in the sand about it.

The Daily Mail's Jenny Hope opens her article with:

Women taking antidepressants such as Prozac during pregnancy are more likely to give birth to children with life-threatening high blood pressure problems, researchers say.


They found that the risk doubles among those taking selective serotonin reuptake inhibitors – the most heavily prescribed antidepressants – in late pregnancy.

I'm pretty passionate about this issue. I've made many friends during my time writing this old blog of mine, many of whom have first hand experience of SSRi related birth defects.

The Daily Mail has published something today that needs to be highlighted. A warning on a packet of pills claiming that taking a pill during pregnancy benefits any risk is merely a smokescreen to the real problem - a weak regulator who cannot/will not acknowledge the teratogen link in SSRi's.

The article mentions a study carried out by researchers at the Centre for Pharmacoepidemiology at Karolinska Institutet in Stockholm Sweden, who reviewed 1.6 million births in total between 1996 and 2007 in five Nordic countries: Denmark, Finland, Iceland, Norway and Sweden.

The study analysed several drugs, including Prozac and our old friend Seroxat, and findings showed that out of 11,014 mothers who used antidepressants in late pregnancy, 33 babies (0.2 per cent) were born with persistent pulmonary hypertension after assessment at 33 weeks.

SSRi birth defect litigation is rife in the US, to my knowledge no such litigation has been started in the UK. It's a sad state of affairs that women and infants have no protection from the UK drug regulator, an example of which becomes apparent when you read the classification of Seroxat in the US.

In the US, Paxil [Seroxat] is classed as a 'Class D' drug. This classification was given by the Food and Drugs Administration [FDA] - The FDA are the American equivalent of our MHRA. [Fig 1]

Fig 1

Furthermore, I have wrote to Seroxat manufacturers GlaxoSmithKline and asked them if Seroxat was a teratogen, their answer?

"GlaxoSmithKline works within the guidelines set out in the Code of Practice of the Association of the British Pharmaceutical Industry (ABPI). This does not allow us to provide advice on personal medical matters to individual members of the public so that we do not intervene in the patient/ doctor relationship by offering advice which properly should be in the domain of your doctor. We would therefore recommend you discuss your concerns with him or her."

The same question was put to the MHRA, their response could only be described as toothless. They would not admit, one way or the other that Seroxat was teratogenic. Their full response is in my book, The evidence, however, is clear...the Seroxat scandal.

I posed this question to both GlaxoSmithKline and the MHRA because items of interest were aired in a US birth defect trial regarding Seroxat.

This from the Kilker v GlaxoSmithKline Birth Defect Trial:

Doctor Sloot's paper demonstrated that Paxil [Seroxat] was a clear teratogen, that it was not just an effect of developmental or birth-weight related effect, that it was a direct teratogen, and that there was a spectrum of defects observed in rat embryos at low doses, establishing that it was a very potent teratogen, more teratogenic than cocaine and retinol, clear teratogens in their own right.

Court documents from the Kilker v GlaxoSmithKline trial, where Glaxo were found guilty of Seroxat being the causation of Lyam Kilker's heart defects, can be found HERE.

Only in America folks.

I get many hits from America on this blog, for those wishing to seek action against pharmaceutical companies who have knowingly put their infants at risk, I suggest the following websites where advice can be sought.

Antidepressant Birth Defects

Prozac Birth Defects

Celexa Birth Defects

Lexapro Birth Defects

You will learn that Baum Hedlund report far more birth defects related to SSRi drugs, defects not mentioned in today's Daily Mail article.

If any British law firms show an interest then I'll big them up on this blog too. Sadly, litigation against pharmaceutical companies in this country is proving to be extremely difficult. The MHRA's failure to acknowledge the teratogen link is proving to be pharma's 'ace up the sleeve'.

Fid

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

AUSTRALIAN ORDERS HERE