Hetlioz: The Body Clock Brain Pellet

It's been a while since I last blogged. GSK has, seemingly, been good boys and girls for a while and Twitter seems to be where all the action is these days regarding the defence of brain pellets and some shocking behaviour from the field of psychiatry. More on that if you follow me on Twitter.

Today, I'm going to revisit a 2014 blog post of mine that was recently brought to my attention by a reader. The post, Blind Date With Vanda's Hetlioz, can be viewed here.

Hetlioz (tasimelteon) is an FDA approved medication for the treatment of Non 24 Sleep-Wake Disorder in the totally blind and is marketed and manufactured by Vanda Pharmaceuticals.

What is Non 24 Sleep-Wake Disorder?

According to Vanda Pharmaceuticals Hetlioz webpage, it's a "serious, chronic disorder that disrupts a person's circadian rhythms. Non-24 affects up to 70% of people who are totally blind, whether you were born blind or became so later in life."

All seems to be above board until you peel back some of the layers.

The clinical trials for Hetlioz are surrounded in controversy:

 - The design of Vanda's primary phase III study changed numerous times, including a complete replacement of the primary endpoint just one month before study results were announced

 - The replacement primary endpoint installed to assess tasimelteon's benefit was created by Vanda and has never been used before in sleep-drug clinical trials, nor was it endorsed by the FDA.

 - Vanda was forced to cut in half the patient enrollment into the tasimelteon clinical trials because totally blind patients with non-24 could not be identified. Even then, Vanda was only able to enroll patients by stretching the clinical definition of non-24.

 - Tasimelteon was only able to demonstrate a benefit for non-24 patients by combining data from two phase III studies. Despite Vanda's claims to the contrary, the phase III studies may have actually failed on their own.

The marketing of Hetlioz has also come under close scrutiny too. Back in 2015, Stat News ran an article regarding the airtime that Vanda Pharmaceuticals had bought to advertise its sleep/wake disorder drug, $29 million worth of airtime to be exact.

Stat News posed a pertinent point, they pointed out that the target audience for Vanda Pharmaceuticals were blind members of the public, so why the heavy promotional push on TV?

Here's one of the ads they ran across America.

Stat News also claimed that the adverts helped Vanda Pharmaceuticals net a tidy profit of $73 million in revenue.

Hetlioz Indications

The product labelling for the drug does not specifically state that it is to be used by blind people only. This leaves the door open for Vanda Pharmaceuticals to target other patients (non-blind).

Public Citizen, a nonprofit consumer advocacy organization, has filed a petition asking the FDA to correct the labeling to indicate the drug is only for patients with the disorder and who are totally blind, a population numbering approximately 100,000. Public Citizen is concerned the existing labeling may encourage off-label use in people who are not blind and have some other type of sleep disorder.

A Concerned Citizen

A concerned citizen recently wrote to me and told me he, and others, were digging into recent activities of the promotion of Hetlioz. He told me, "We are extremely confused by what we are finding. First off, it appears they are targeting Medicaid patients for Hetlioz with an estimated 80% of revenue coming from Medicare part D. Second, how can they be seeing 2x-3x demand from sighted patients vs blind if non-24 affects mostly blind people and is rare in sighted patients? Third, Cafepharma and glassdoor posts seem to indicate that there is rampant off-label promotion of Hetlioz going on via the company's psychiatric initiative.  This is just a sampling of what we are finding."

Vanda Drug Reps

The same citizen sent me two videos in which we can see Vanda Pharmaceuticals drug reps target patients and not doctors, as is the norm for drug company reps. The first video sees two reps for Vanda speak with what appears to be a mixed audience of visually impaired and blind subjects at Lighthouse, an organisation that promotes the independence, equality and self-reliance of people who are blind or have low vision. What is striking is the Vanda rep at the beginning of the first video asks the audience to fill out the paperwork if they feel they have any symptoms and give it to her and she will contact their physician. I'm unsure of the legality of this. The second rep throws out the question, "How many of you have difficulty sleeping at night?" When 6 or 7 raise their hands he tells them that it could be because they have 'Non 24 sleep/wake disorder'. He then goes on to tell the audience how everyone has a "master body clock in their brains."

I have to point out that neither of the reps mentioned the drug Hetlioz.

One of the audience members tells the rep she has Non 24 and takes Seroquel for it. Hmm.

If anything, this video gives an insight into how drug company reps play their audience. I found it fascinating, I hope you do too.

PS - He's not very good.

**Raw copies of both videos have been downloaded.

So, just as brain pellets were promoted because people had a 'chemical imbalance', along comes another mystery brain anomaly, this time it involves some sort of ticking clock. If you watched the video above you'll note how many times the rep drums home the 'body clock' claim.

The second video is much shorter than the first and shows pamphlets left behind by the Vanda reps. The leaflets, although visible are also written in braille and direct readers to http://www.non-24.com/ - where there's more talk about the 'body clock.' Again, there doesn't seem to be any direct-to-consumer advertising of Hetlioz on the webpage but there's plenty of talk about patients going to see their doctor to explain they may have symptoms of Non-24.

I can only speculate that Vanda reps have already visited their doctors and planted the 'Non-24' seed and what new drug can treat it.

As I mentioned above, I'm not sure if drug company reps targeting patients is entirely ethical so I wrote to a former drug company rep turned whistleblower for her opinion. I asked her if this was legal. She replied:

"No, this is not legal in the U.S. but I cannot provide any documentation to this effect. We were just instructed by the companies that I worked for that it was illegal to interact with patients regarding care/drug regimens. Unless something has changed...I left the industry in the year 2000."

In my 2014 blog post I mentioned the link between Vanda Pharmaceuticals and The National Sleep Foundation (NSF). 

New information I've learned is that Charles A. Czeisler, an American physician and sleep researcher, was President of NSF and is/was on Vanda's scientific advisory board. Also, Dr. Stephen Lockley, the Harvard sleep expert overseeing the Hetlioz clinical trials, received grant support from Vanda Pharmaceuticals.

Blogger, 'Frugal Nurse', has also been investigating Non-24 and Hetlioz. She writes:

On January 31, the Food and Drug Administration announced its approval of tasimelteon for treatment of Non-24.

Approval was based on results of 2 trials: . . . a 26-week study that included 84 patients, . . . and a 19-week trial that included 20 patients . . .

Really? Market approval based on 104 patients over 6 months?

And what were they testing for exactly? Patients experiencing a better night’s sleep, or less daytime drowsiness? No, something called “entrainment” or re-setting of circadian rhythm, measured by melatonin byproducts in the urine.

Frugal nurse also has an opinion on the Non-24 website. She writes:

The informational website for Non-24 is classic pharmaceutical advertising.

It’s not about selling a drug—at least not directly. It’s about helping you understand what Non-24 is and why you might suffer from it. The site helpfully (and slyly) provides a sidebar of symptoms to aid self diagnosis:

Not being able to sleep when you want

Excessive sleepiness during the day

Daytime napping or dozing off during the day

Periods of poor sleep quality at night

Sleeping through the night, but not waking up feeling alert and refreshed

Problems with focus and concentration; trouble with memory

Difficulty with daily tasks

Feeling irritable

Oh my God, I’ve got Non-24!!

If you are “experiencing any of these symptoms,” you are invited to fill out your name and address and “give permission” for Vanda to send you “information about Non-24 and about medicines that treat Non-24.”

As an added incentive, when you sign up, Vanda will make a $24 donation to the “blindness community.”

We can see from her research that Vanda's marketing is widening the net. They don't just want blind or partially sighted people to ask for this drug, they want, it appears, people with insomnia too, a condition that Hetlioz is not indicated for.

Jet Lag

In March this year, Vanda Pharmaceuticals announced that Hetlioz demonstrated significant and clinically meaningful benefits in nighttime and daytime symptoms of jet lag disorder. The press announcement stated:

Vanda intends to seek marketing approval for the use of Hetlioz in the treatment of jet lag disorder.  Vanda believes that if Hetlioz is approved by regulatory authorities for the treatment of jet lag disorder it will potentially offer a therapeutic solution to many travellers and will likely represent an important commercial opportunity for the company. 

You're not kidding! According to drugs.com the cost for Hetlioz oral capsule 20 mg is a staggering $15,186 for a supply of 30 capsules, depending on the pharmacy you visit.

It's no surprise that Vanda are trying to tap into the market of jet lag. It is reported that more than 30 million US residents make trips abroad each year to overseas destinations. Of these, 60% (approximately 20 million) travel to destinations in Europe, Middle East and Asia. That's an awful lot of potential customers for Vanda.

Another market they will no doubt be persuading doctors to prescribe to is the insomnia market. Around 1 in 3 people have at least mild insomnia. Many poor sleepers have developed poor sleep habits.

So, the body clock drug that was initially aimed at blind people now has a much larger potential. Jet lag and insomnia will become the new 'Non 24 Sleep/Wake Disorder'. Sufferers will be spun the story about 'body clocks' and the importance of setting the timing of that clock back to normal.

What next?

Will we see Hetlioz pushed on kids who can't sleep because they have normal teenage worries, or perhaps the man or woman who are facing employment stresses and can't sleep? Remember, the FDA left the door wide open when they agreed that this drug could come to market. Hetlioz has not been studied in children and it is not recommended for use in children but history shows that drug companies always try to widen the net when selling to the public. One only has to look at the group of SSRIs that are currently prescribed off-label to children.

How Does Hetlioz Work?

Hetlioz works to enhance the effects of the receptors for melatonin. In particular, it binds and augments the MT1 and MT2 receptors within the brain. This induces sleep.

So, is Hetlioz merely another brain pellet then, one being sold on the back of a spinning story that involves body clocks in the brain, just as SSRIs were heavily promoted on the spinning story of a chemical imbalance in the brain?

Finally, last month the FDA issued a warning letter to Vanda Pharmaceuticals. The warning letter chastized Vanda for failing to warn Hetlioz users of its most common adverse reactions, namely; headaches, increased alanine aminotransferase, which is the term used for elevated liver enzymes, nightmares or unusual dreams, and upper respiratory or urinary tract infection. These are common adverse reactions, folks!

Nightmares or unusual dreams? Nothing like taking a drug to help you with sleep, huh.

Bob Fiddaman

Back Story

Blind Date With Vanda's Hetlioz

Blind Date With Vanda's Hetlioz

An American friend of mine sent me an email the other day. She told me how she had seen an ad aired on TV for a drug called Hetlioz (tasimelteon). Apparently, it's a pill to help those who suffer with Non-24-hour Disorder.

I admit I had to look this disorder up. My first thought was, Christ! They want to treat people who refuse to watch Kiefer Sutherland's character Jack Baur in FOX TV's 24?

Alas, I was wrong.

Non-24-hour Disorder, according to Hetiloz manufacturers, Vanda Pharmaceuticals, is...

... a chronic circadian rhythm disorder that occurs when individuals are unable to synchronize their endogenous circadian rhythm to the 24-hour day. Non-24 is most commonly found in blind individuals lacking the ability to perceive light, the primary environmental cue for synchronizing the circadian system daily. In general, individuals with Non-24 suffer from a variety of clinical symptoms as they cycle in-to and out-of phase resulting in disrupted nighttime sleep patterns and/or excessive daytime sleepiness.

Vanda had to convince the American drug regulator, the FDA, that their drug worked and was safe through a series of clinical trials. These trials have been slammed.

For instance...

• The design of Vanda's primary phase III study changed numerous times, including a complete replacement of the primary endpoint just one month before study results were announced

.

• The replacement primary endpoint installed to assess tasimelteon's benefit was created by Vanda and has never been used before in sleep-drug clinical trials, nor was it endorsed by the FDA.

• Vanda was forced to cut in half the patient enrollment into the tasimelteon clinical trials because totally blind patients with non-24 could not be identified. Even then, Vanda was only able to enroll patients by stretching the clinical definition of non-24.

• Tasimelteon was only able to demonstrate a benefit for non-24 patients by combining data from two phase III studies. Despite Vanda's claims to the contrary, the phase III studies may have actually failed on their own.

[Source]


Despite all of the above, Hetiloz was approved by the FDA earlier this year.

Astroturfing

Now there's a word.

Astroturfing is the practice of masking the sponsors of a message or organization (e.g. political, advertising, religious or public relations) to make it appear as though it originates from and is supported by grassroots participant(s). It is a practice intended to give the statements or organizations more credibility by withholding information about the source's financial connection.

Step forward The National Sleep Foundation.

Trawling through their website I learned that their Non-24-Hour Sleep Wake Disorder section is sponsored by Vanda Pharmaceuticals. I flicked the following email to Vanda...

Dear Sirs,

Many pharmaceutical companies are now suggesting that they are going to be more transparent in regard to clinical trials and sponsorship's etc.

I noticed that the sleep foundation have a section on their website that is sponsored by Vanda Pharmaceuticals.

As a matter of public interest could you tell me if this was a financial arrangement, if so, how much?

In typical Pharmafia fashion Vanda did not reply, opting instead to check me out [fig 1] - Click image to enlarge.

Fig 1

I posed pretty much the same question to the National Sleep Foundation via their Twitter page. [Fig 2]

They had the decency to answer me but didn't really answer the question I put to them.

Fig 2

Not related in any way to Vanda?

Here's the sponsored section on the Sleep Foundation's website [Fig 3] - Click on image to enlarge and read the bottom left of the image.

Fig 3

Alternatively, click here.

I pressed the Sleep Foundation for an answer - to date, they have failed to respond.

I dug a little deeper regarding Vanda's drug Hetiloz.

In July 2013 it was reported that Vanda Pharmaceuticals Inc. were facing at least one shareholder lawsuit surrounding late-stage trials for the company's sleep disorder drug Hetiloz.

In one class-action complaint, Small v. Vanda Pharmaceuticals Inc. et al., it's alleged that Vanda and its officers issued materially false or misleading statements about Tasimelteon’s efficacy and the results of its Phase III clinical trials. Specifically, it is alleged that Vanda changed the design of the  primary Phase III study several times, including a complete replacement of the primary endpoint  one month before results were announced, because the company was in possession of data suggesting that the original primary endpoint was not going to be met; used a replacement primary endpoint that had never been used before in sleep-drug clinical trials and was not endorsed by the FDA; enrolled patients in the Phase III trials by “stretching” the clinical definition of Non-24; and combined data from two Phase III studies in order to demonstrate a benefit for Non-24 patients, where the two Phase III studies failed individually.

The full complaint can be read here.

Amazing that the FDA went ahead and gave a licence to Hetlioz... then again, the FDA are basically an extension of the pharmaceutical industry.

Non-24-hour Disorder is a new one on me. As for the treatment of it, Hetiloz, experiments with rodents revealed fertility impairments, an increase in certain cancers, and serious adverse events during pregnancy at dosages in excess of what is considered the "human dose". [1] [2]

I can only presume that these warnings will be printed in braille for expectant blind mothers?

Then again since when have pharmaceutical companies protected their patients?

Bob Fiddaman 

Blind people need all the facts too

References

[1] "Side Effects Drug Center: Hetlioz Clinical Pharmacology". RxList. February 10, 2014.

[2] Side Effects Drug Center: Hetlioz Warnings and Precautions". RxList. February 10, 2014. "In animal studies, administration of tasimelteon during pregnancy resulted in developmental toxicity (embryofetal mortality, neurobehavioral impairment, and decreased growth and development in offspring) at doses greater than those used clinically."

You can follow the National Sleep Foundation on Twitter here.

  

Anxiety UK Charity - Astroturfing?

Anxiety UK - Astroturfing?

An astute Seroxat Sufferers regular, Ruth, emailed me earlier with a charity she had stumbled across whilst researching. That charity is Anxiety UK.

Anxiety UK's 'About Us' page proclaims that it is a national registered charity formed 40 years ago by a sufferer of agoraphobia for those affected by anxiety disorders. It continues with:

Today we are still a user-led organisation, run by sufferers and ex-sufferers of anxiety disorders, supported by a high-profile medical advisory panel.

 All fine and dandy then. I have much respect for patient support groups...but a high-profile medical advisory panel?


The panel, which consists of medical advisers and patrons, throws up some names with interesting backgrounds in the field of psychiatry.

Top of the list is Professor David Clark. The Anxiety UK page describes him as thus:

Born in Darlington, England. He studied Experimental Psychology at Oxford University. His clinical training was at the Institute of Psychiatry, Kings College, London in Clinical Psychology. He was a lecturer in Clinical Psychology and Professor in Psychiatry research fellow at Oxford University.

A quick Google search shows that Clark is a firm believer in Cognitive therapy versus the use of medication. His co-authored paper, 'Cognitive Therapy Versus Fluoxetine in Generalized Social Phobia: A Randomized Placebo-Controlled Trial.' [1] found that Cognitive therapy is more effective than fluoxetine in people with generalised social phobia.

A decent approach but it leaves me somewhat baffled why Professor David Clark sits on a panel of a charity that directs readers of its website to Pfizer and Lundbeck?

"Generalised Anxiety Disorder" [GAD], writes Anxiety UK, "can be defined as a disorder in which the sufferer feels in a constant state of high anxiety and is often known as ‘chronic worrying’ or a ‘free floating’ anxiety condition."


Anxiety UK's GAD information page goes one step further, it would appear that they are cutting out the middle man [Doctor] as they offer you a self-assessment on their page.

If you can answer YES to most of the questions it is likely that you are affected by GAD.
During the past 6 months:- 

Do you feel that you have been nervous/on edge most days over the past 6 months?
Did you have problems falling asleep
Did you feel tension in your muscles because of feeling on edge?
Did you frequently feel tense and irritable? 

Anxiety UK strongly advises that people seek further information and guidance from their GP who will be able to make a formal diagnosis.

I cannot imagine for one minute that your average doctor would recommend Cognitive Therapy to any patient who had answered 'Yes' to most of the above questions. A prescription would more than likely be written for a medication that apparently can help with this 'disorder'.

The conveyor belt 


Fear not, even if you, like me, feel that medication can cause more harm than good, Anxiety UK are on hand to offer you more information. They do this by stating:


Want to know more?


The Anxiety UK site has information on a range of resources to provide more detailed information and help.

And that help directs you into the bowels of the pharmaceutical industry, whose main objective is to sell you drugs.

Here's a snapshot of Anxiety UK's GAD page:

Whilst I applaud the efforts of Professor David Clark to show that Cognitive Therapy works better than Prozac, I'm left scratching my head why he would wish to remain on a panel of a charity that directs its members to two pharmaceutical companies who manufacture drugs that, miraculously, can cure the very same symptom [GAD] that you have self-assessed yourself with.


Anxiety UK's medical advisers and patrons include:

Professor Cary Cooper CBE - Who is the author of over 100 books on occupational stress, stress medicine and industrial and organizational psychology.

Professor Robert Edelmann - Whose main research interests relate to chronic blushing.

Dr David Baldwin - Whose research interests include the clinical psychopharmacology of anxiety and depressive disorders and the prevention of suicidal behaviour.

I find myself wondering why Baldwin would be part of such a charity that directs members to Pfizer and Lundbeck, both have drugs known to cause suicide.

Pfizer's Sertraline, whose brand names are Zoloft and Lustral, has been reported to cause severe withdrawal problems, suicide and, some quarters now believe, birth defects.

Lundbeck's citalopram and escitalopram, whose brand names include Cipramil, Celexa, Lexapro and Cipralex, have all been associated with suicide, homicide, withdrawal problems and many believe, birth defects. More on Lunbeck and citalopram HERE.

Do you, like me, find it odd that a charity, with esteemed professionals as its medical advisers, would endorse the above pharmaceutical companies, or at least direct it's members to gain more information from these pharmaceutical companies?

With this in mind I contacted Anxiety UK early this morning with the following:

Dear Anxiety UK,


I am the author of the paperback, The evidence, however, is clear...the Seroxat scandal and also the blog, Seroxat Sufferers Stand Up And Be Counted.


An astute reader of mine recently alerted me to your page where I learned that you are directing readers/members to two pharmaceutical companies, namely Pfizer and Lundbeck, for 'recommended reading'


Question:


Why are you directing readers/members to two pharmaceutical companies whose antidepressant drugs are the subject of withdrawal problems, suicide ideation and birth defects?

By 5pm UK time, Anxiety UK had not responded.


Footnote:

In 2006 Pfizer announced that the European Commission has approved Lyrica [pregabalin] for the treatment of generalized anxiety disorder [GAD] in adults.

In early 2010 Pfizer announced that the Food and Drug Administration [FDA] issued a Complete Response letter regarding the company's New Drug Application [NDA] for Lyrica [pregabalin] capsules CV as a monotherapy treatment for generalized anxiety disorder [GAD]. The FDA determined that the data contained in the NDA were insufficient to support approval.

The registrant of Anxiety UK is listed as The National Phobic Society. Their website, aptly entitled, "No More Panic" also offers help of the medication kind.

So, are Anxiety UK an astroturfing group? If not, why are they directing its readership to two pharmaceutical companies, with a history of manufacturing drugs known to cause suicide?

It's medical advisers may wish to reconsider their position on Anxiety UK's panel, I know I would.







[1] Cognitive therapy is more effective than fluoxetine in people with generalised social phobia


Fid 


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


AUSTRALIAN ORDERS HERE

Australia: Beyond Blue... Beyond Belief!

I've been corresponding with an Australian author of late [Rebekah Beddoe] and we started musing over the help needed when withdrawing from SSRi's. Rebekah wrote a heart wrenching account of her time on a whole host of anti psychotic and antidepressant drugs, her book aptly entitled 'Dying For A Cure', is a terrific read and highlights the dangers of these drugs but more importantly the lack of knowledge the medical profession have regarding the addictive qualities and consequent tapering programs [or lack of] for patients.

Rebekah pointed me to Beyond Blue, an Australian organisation that provides information about depression to consumers, carers and health professionals. To be fair, I had heard of these before and have, in the past, visited their page. I seem to remember a conflict of interest regarding Beyond Blue but can't for the life of me remember whether I wrote it or read it elsewhere [my memory isn't what it used to be, thanks GSK]

The Beyond Blue website is pretty impressive, looks like a lot of time and effort [and money] has gone into its construction. They provide a wealth of information through various links, I say wealth in the 'an awful lot' sense.

Beyond Blue, it seems, are well respected throughout Australia and their mission reads: "Our mission is to provide a national focus and community leadership to increase the capacity of the broader Australian community to prevent depression and respond effectively"

They have disabled any right clicking on their web page so one cannot copy and paste. Their full mission statement can be found HERE.

My interest in Beyond Blue became heightened when I read their 'Medications' page.

I'm angry.

Angry because all the hard work myself and others are doing to raise awareness about SSRi's is single handedly being destroyed by advice given by Beyond Blue. Some of you may be aware of my recent meeting with the MHRA where the withdrawal process of SSRi's was discussed, certain campaigners for mental health wrongly assumed I was there to discuss Seroxat... I have still not received an apology for their wrongful assumption [I can live with it]

I digress.

Now, there are those that gently beat the drum and there are those that bang it loudly. Gently beating the drum is fine if you are a mouse politely asking the owner of your abode to buy more cheese. Banging it is a different matter, more of a demand. I believe that it was my 'banging' that got me my meeting with the MHRA. I'm not blowing my own trumpet here, although it may appear so. All I am saying is, everyone needs to stop pissing around being a mouse and start pissing on the likes of regulators and organisations such as Beyond Blue... not to mention the pharmaceutical companies that manufacture, market and promote pills that can possibly cause more damage than actually rectify the illness.

Beyond Blue - Medications

Why do I need to take antidepressant drugs?

• Medical research indicates that depression is often associated with specific changes in the chemical message systems of the brain (serotonin, noradrenaline, dopamine).

• Antidepressant medication can quickly relieve poor sleep, anxiety, tiredness, poor appetite, poor concentration and agitation.

• Antidepressant drugs do not change your personality.

• Antidepressants take several weeks to have their full effect.

• Antidepressants are usually prescribed for a period of time after your symptoms have stopped (six to 12 months) to prevent relapse of the depressive illness.

• For mild or moderate depression, psychological treatments alone may be sufficient.

• Antidepressant drugs do not make people more dangerous.

"Medical research indicates that depression is often associated with specific changes in the chemical message systems of the brain (serotonin, noradrenaline, dopamine)."

So where is this research? Was it conducted by Beyond Blue, if so was it funded by the likes of GlaxoSmithKline Australia who STILL tout the chemical imbalance nonsense on their Australian web page. The Therapeutic Goods Agency [TGA] don't seem that bothered by it, I've mailed them a few times about this fraudulent promoting of a dangerous class of drugs before [they have never got back to me on the issue] - maybe I am out of their 'jurisdiction' and they don't see my banging as a major concern? 'The Pom will stop mailing us if we ignore him'. Hmmm, Now where have I experienced that before? Here is what GSK Australia say about Aropax [Seroxat, Paxil, paroxetine]

Snip: "Aropax corrects the chemical imbalance and so helps relieve the symptoms of depression."

PROVE IT!

It's a great marketing strategy Glaxo, hats off to you for a great subliminal message to concerned patients who choose to browse your Aropax page looking to see if it is safe for them or their family, friends, neighbours to take.

Back to Beyond Blue

"Antidepressant medication can quickly relieve poor sleep, anxiety, tiredness, poor appetite, poor concentration and agitation."

It can also quickly bring on suicidal and homicidal thoughts or do Beyond Blue not know about the case of Donald Schnell? In 1998, GlaxoSmithKline, maker of Paxil, was ordered to pay $6.4 million to surviving family members after Donald Schnell, 60, just 48 hours after taking Paxil [Aropax], flew into a rage and killed his wife, daughter and granddaughter.

They were ordered to pay! That suggests to me that they played a part in that particular crime.

So apart from antidepressant medication quickly relieving poor sleep, anxiety, tiredness, poor appetite, poor concentration and agitation, it can also bring about rage, homicide and suicide. FACT! Unless Glaxo paid $6.4 million dollars to the Schnell family for another reason other than it was their drug that was partly responsible for the actions of Donald Schnell?

Maybe Glaxo's lawyers would care to comment?, they visit this blog on a regular basis.

"Antidepressant drugs do not change your personality."

No? Mild mannered Donald Schnell turned into a violent murderer. Some personality change doncha think? The current Paxil Petition will show you personality changes of people after taking the miracle pill that was supposed to help them! On a personal front, my personality changed when I was on it, reading Rebekah Beddoes book and one cannot fail to see the personality change in her. Quite where Beyond Blue get this information from is not known. I can tell them this - They are wrong and they are wrong big time. Check out Paxil forums, check out Efexor forums, Prozac forums... the list goes on and on.

"Antidepressants take several weeks to have their full effect."

But hit the bloodstream immediately. And what exactly is their 'full effect'?

Are we talking about numbing you into a zombie, stripping you of empathy, causing you sleep disturbances, causing you agitation, causing you audible problems. Forget the sickness, dizziness and diarrhea, they are an absolute breeze to deal with and one that Glaxo mouthpiece, Alistair Benbow, seems to think is the only problems with one particular SSRi.

"Antidepressants are usually prescribed for a period of time after your symptoms have stopped (six to 12 months) to prevent relapse of the depressive illness."

Subliminal message here folks. Can you read through the lines? I can.

It's genius Pharma marketing. Let's play it out. [Scenario]

PATIENT: I'm so low Doctor, I feel so blue and down.

DOCTOR: Here, take these twice daily [Hands patient prescription for SSRi's]

PATIENT: But these are addictive aren't they? I've heard so much bad press about them.

DOCTOR: Scaremongers, they are safe to take because the medicines regulators are on the ball, they wouldn't allow drugs like these onto the market if they didn't think they were safe.

PATIENT: Thanks for the reassurance Doc.

DOCTOR: No problem. Now, come back and see me in a month.

The patient goes back to see the doctor because their depression doesn't seem to be shifting. The Doctor increases the dose of the SSRi. Once again he puts the patient's mind at rest, telling them these drugs are not addictive.

So the patient remains on these SSRi's for a period of [let's say 8 months]

8 months later...

DOCTOR: It seems you are over your depression, I think it's time we tapered you from your medicine.

PATIENT: Tapered?

DOCTOR: Yes, these drugs are quite dangerous if you stop taking them abruptly.

PATIENT: You did not mention this when you first prescribed them to me?

DOCTOR: Come, come now, you will be fine. Snap the tablet in half and reduce your dosage by taking half a day instead of a full tablet.

The patient, on the advice of their Doctor, complies. One month or so later they are back in his surgery. Doctor 'Knowitall' writes them out another prescription for their SSRi and tells them that the depression hasn't quite lifted. He recommends they go back to the original dose.

Here we have what Pharma wanted. A brilliant marketing strategy that would dupe the public for years... still does unless one has successfully tapered off the shit.

"For mild or moderate depression, psychological treatments alone may be sufficient."

Also expensive and a drain on resources. Solution?

"Take these whilst we get you some counselling"

"Thanks Doc, but aren't they addictive..."

The cycle begins.

"Antidepressant drugs do not make people more dangerous."

Here's a question for Beyond Blue and I want them to take their time in answering it.

What do the following 'events' have in common:

Cho Seung-Hui's murderous rampage – during which he killed 32 students and faculty members at Virginia Tech

1988, 31-year-old Laurie Dann walked into a second-grade classroom in Winnetka, Ill., and began shooting. One child was killed and six wounded.

19-year-old James Wilson went on a shooting rampage at the Greenwood, S.C., Elementary School and killed two 8-year-old girls and wounded seven others.

Kip Kinkel, a 15-year-old of Springfield, Ore., in 1998 murdered his parents and proceeded to his high school where he went on a rampage killing two students and wounding 22 others

Patrick Purdy, 25, in 1989 opened fire on a school yard filled with children in Stockton, Calif. Five kids were killed and 30 wounded.

Steve Lieth of Chelsea, Mich., in 1993 walked into a school meeting and shot and killed the school superintendent, wounding two others.

10-year-old Tommy Becton in 1996 grabbed his 3-year-old niece as a shield and aimed a shotgun at a sheriff's deputy who accompanied a truant officer to his Florida home.

Michael Carneal, 14, opened fire on students at a high school prayer meeting in Heath High in West Paducah, Ky. Three died and one was paralyzed.

In 1998, 11-year-old Andrew Golden and 14-year-old Mitchell Johnson apparently faked a fire alarm at Westside Middle School in Jonesboro, Ark., and shot at students as they left the building. Four students and a teacher were killed.

In 1999, Shawn Cooper, 15, of Notus, Idaho, took a shotgun to school and injured one student.

April 20, 1999, Eric Harris, 18, and Dylan Klebold, 17, shot and killed 12 classmates and a teacher and wounded 24 others.

Todd Smith walked into as high school in Taber, Alberta, Canada in 1999 with a shotgun and killed one and injured a second student.

Steven Abrams drove his car into a preschool playground in 1999 in Costa Mesa., Calif., killing two.

In 2000, T.J. Solomon, 15, opened fire at Heritage High School in Conyers, Ga., six were wounded.

Seth Trickey of Gibson, Okla., 13, opened fire on his middle-school class, injuring five.

Elizabeth Bush, 14, shot and wounded another student at Bishop Neumann High in Williamsport, Pa.

Jason Hoffman, 18, wounded two teachers at California's Granite Hills High School.

Cory Baadsgaard, 16, took a rifle to his high schooland held 23 classmates hostage in 2001.

In Tokyo in 2001, Mamoru Takuma, 37, went into a second-grade classroom and started stabbing students. He killed eight.

Duane Morrison, 53, shot and killed a girl at Platte Canyon High School in Colorado in 2006.

In 2005, 16-year-old Native American Jeff Weise on the Red Lake Indian Reservation in Minnesota shot and killed nine people and wounding five before committing suicide.

In 1986, 14-year-old Rod Mathews of Canton, Mass., beat a classmate to death with a baseball bat.

William Cruse in 1987 was charged with killing six people in Palm Bay, Fla.

Bartley James Dobben killed his two young sons by throwing them into a 1,300-degree foundry ladle.

Joseph T. WesBecker, 47, shot 20 workers at Standard Gravure Corp. in Louisville, Ky., killing nine.

In 1991, 61-year-old Barbara Mortenson, "cannibalized her 87-year-old mother.

In 1992, Lynnwood Drake III, shot and killed six in San Luis Obispo and Morro Bay.

Sixteen-year-old Victor Brancaccio attacked and killed an 81-year-old woman, covered her corpse with red spray-paint.

Dr. Debora Green in 1995 set her Prairie Village, Mo., home on fire, killing her children, ages 6 and 13.

Kurt Danysh, 18, shot and killed his father in 1996.

Beyond Blue claim "Antidepressant drugs do not make people more dangerous." All of the above have one thing in common. ALL were on a variety of antidepressant medications! [Source]

Beyond Blue are 'bigging up' the use of antidepressants on their web page. To me they are putting lives at risk with false and misleading information, that's my opinion and if they or Pharma don't like it then tough titty. I'm not about to stand by and let Beyond Blue [respected or not] get away with the advice they give regarding antidepressant use.

Doctors all over the world need educating, as do the regulators. If organisations such as Beyond Blue continue to hand out advice straight from the book of Pharma then Doctors and patients will continue to go through the routine of the scenario I painted above. They will see the illness as the cause and not the antidepressant.

And that, ladies and gentlemen is what Pharma want you to believe.

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

CHOICE & MEDICATION ASTROTURFING?

Seroxat Secrets is currently running with two stories about a website that is offering support to mental health patients. The website, Choice and medication, offers advice on Seroxat and other SSRi's that seems to be straight out of the book of Pharma:

1 How does Seroxat work?
...It is known that this serotonin is not as effective or active as normal in the brain when someone is feeling depressed...

2 Are SSRIs addictive?
...They are not addictive, but if you have taken them for eight weeks or more you may experience some mild “discontinuation” effects if you stop them suddenly...

3 Can I stop taking an SSRI suddenly?
...It is unwise to stop taking them suddenly, even if you feel better. Two things could happen. Firstly, your depression can return if treatment is stopped too early (see “How long will I need to keep taking them for?”). Secondly, you might also experience some mild “discontinuation” symptoms (see also above)...

Stephen Bazire claims to be the author of the website, he also has a number of books available on Amazon that seem to promote use of drugs used in the treatment of mental health.

Choice and medication seems to be nothing more than an agent for Pharma.

Read what Seroxat Secrets has to say about the matter here and here.

Read the definition of Astroturfing here

Hats off to Seroxat Secrets for exposing this scam

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON