Health Canada Under Scrutiny

Health Canada, the Canadian medicine's regulator are to be examined and reported on with regard to prescription pharmaceuticals in Canada.

In a recent motion the Honourable Senator Ogilvie moved, seconded by the Honourable Senator Frum that the Senate Standing Committee on Social Affairs, Science and Technology be authorized to examine and report on prescription pharmaceuticals in Canada, including but not limited to:

(a) the process to approve prescription pharmaceuticals with a particular focus on clinical trials; 

(b) the post-approval monitoring of prescription pharmaceuticals;

(c) the off-label use of prescription pharmaceuticals; and

(d) the nature of unintended consequences in the use of prescription pharmaceuticals.

The committee are to submit its final report no later than December 31, 2013, whereupon it is hoped that by March 31, 2014 all findings will be made public.

I'm always weary of "investigations" into the way pharma does it's business through agents, end of the day Health Canada are merely batting for the same side as the pharmaceutical industry, I see no implementations of the 16 recommendations made at the Sara Carlin inquest almost a year and a half ago.

What's needed from this investigation is not the bog-standard recommendations, Health Canada will more than likely ignore them anyway. What is needed is for Health Canada to be more transparent, to open it's doors to the parents that have lost children to the very same drugs they were supposed to regulate.

I don't really care much for medicine regulators, it's apparent to me since I have been writing this blog that they are about as useful as chocolate teapot. Some will argue that we need them in place to protect us from harmful drugs, experience tells me that they do everything but that.

Regulators do not regulate, they merely pass the buck, they are pretty powerless and exist, it appears, to protect the purse strings of the pharmaceutical industry.

I hope the Senate Standing Committee on Social Affairs, Science and Technology can bring about some changes with implementations and not recommendations.

The motion can be viewed HERE





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ABC News Foster Care Investigation

Following on from Part I, ABC News aired the second part of their investigation into the mass drugging of children in Foster care homes across America. Part II centered around the death of 6 year-old Gabriel Myers who, after being placed in a Foster care home, was prescribed a powerful mix of antipsychotic drugs after a 5 minute consultation with his psychiatrist, Dr. Sohail Punjwani.

ABC News catches up with Punjwani to ask him why.

Also featured in the ABC News investigation is FDA spokesperson, Robert Nelson. Nelson is asked, in essence, who is going to accept responsibility for the mass drugging of children. His response and demeanor during the short interview leaves a lot to be desired.



Later today ABC News will air the third part of their investigation.

The 'off-label' prescribing of powerful mind altering drugs to children is a huge problem of epic proportions not only in America but other countries too. Limp-wristed medicine regulators shirk any responsibility claiming that the warnings about prescribing these medications to children are clearly stated on the labelling and in warning letters to doctors. They then sit back and allow the very same doctors they have warned to prescribe the medication to children 'off-label'.

It's mindless and the only industry that I can think of where an unapproved product is...well, approved.

My disdain for medicine regulators is well known, only last week I covered the MHRA's proposed SSRI Learning Module for Clinical Practitioners in the UK and showed how utterly contradictory it is. [Parts 1, 2 and 3.]

What we have here is a failure by adults to hold up their hands and accept responsibility. It's buck-passing of the highest order and is basically putting children on a never ending Highway to Hell.

Senators and congressmen take note: The root of this problem is The Diagnostic and Statistical Manual of Mental Disorders [DSM]. Once you see how utterly ridiculous the "illnesses" are, you will be able to understand why tax payers are being ripped off at the expense of the welfare and safety of children. You want to eradicate the problem, then go to the root cause and ask the authors of the DSM for scientific proof. It's a manual that is basically a licence to print money for the pharmaceutical industry.

Related links:

12 Year-Old Kid Speaks before Senate and Congress about Psychiatric Drugs

U.S. Government Fails to Oversee Treatment of Foster Children With Mind-Altering Drugs ABC News Part I

Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System

In Memory of Gabriel Myers






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12 Year-Old Kid Speaks before Senate and Congress about Psychiatric Drugs

Sen Tom Carper: "We need to figure out what works." 

There's always a defining moment in history, I believe I just witnessed it, I never expected that defining moment to come from the voice of a 12 year old boy from the state of Texas.

Ke' Onte Cook gave evidence before the Senate and Congress today regarding his experience in Foster care. The Subcommittee on Federal Financial Management, Government Information, Federal Services, and International Security had gathered in the wake of a report by The US Government Accountability Office [GAO] that showed that the prescribing of drugs to children in state care is out of control.

Startling facts were revealed in the online stream:

• Children in Foster care were prescribed mind altering drugs up to 4.7 more times than children not in care.

• Thousands of children had received more than the recommended dose of mind altering drugs

• Over 600 children in state care were on 5 or more mind altering drugs at any given time

• 5,265 infants [under the age of 1] were prescribed mind altering drugs.

The bullet points above may shock you, what's even more shocking is that this data comes from just 5 States pooled in the GAO investigation. Can you begin to imagine the figure if all the US States were pooled?

Sen Brown [Massachusetts] told the congress that nearly 40% of Foster children in Massachusetts had been prescribed 1 or more psychiatric drug. On learning that over 5,000 infants across five States had been prescribed these drugs he said it was "shocking and disturbing".

Sen Carper, who chaired the meeting, added, "We can't stand idly by while children's lives are put in danger."


Sen Collins [Maine] added her disgust with, "I am troubled by the use of psychiatric drugs for use in children in Foster care." She also told congress that the GAO report had found that in Texas children in care were 53 more times likely to be prescribed 5 psychiatric drugs at once more than children not in care and added that there was thousands of infants on psychotropic drugs.

The Senate sat in stunned silence as they listened to a statement from 12 year-old Ke' Onte Cook. Ke' Onte had been place in care from the age of 6 and a half. He told the panel that he was told that if he didn't take his drugs he would be punished by not being allowed to watch TV. He did not know why he was on drugs or how many he was taking, he could not remember. Ke' Onte also informed the panel that later on he had been diagnosed with Post Traumatic Stress Disorder [PTSD] Insomnia, Depression and Attention Deficit Hyperactivity Disorder [ADHD] during which he could not process thoughts, felt glazed and tired, had stomach aches and a "lights out" mood. He added that he was first prescribed the medications [3 different drugs a day] because he was throwing tantrums and was upset after being taken into State care.

Sen Carper asked Ke' Onte how he managed to get off the medication. Ke' Onte informed him that he sought the help of an Attachment Therapist who talked to him about his history and added that "It helped me to get over the anger." When asked by Sen Carper if he had a message he would like to add Ke' Onte replied, "Medication isn't going to help children with problems, it just sedates them."


Sen Carper concluded that "We need to figure out what works." and told Ke' Onte, "Some good is going to come out of what you experienced."


Ke' Onte received a round of applause from the Senate and Congress... I would have given him a 21 gun salute.

GAO's full report can be read HERE

Here's Sen Carper's Opening Statement.


Back in March 2011 myself and Ablechild's Sheila Matthews exposed a billion dollar drug company law firm and their involvement in the Connecticut Foster care system. Full article HERE

Sitting Back in Anger

There are those that do then there are those that...well, that just sit there shrugging their shoulders not giving a toss.

There is a global problem with children being prescribed mind-altering drugs, in fact the increase in drug prescriptions stranglely does not run concurrent with the increase in apparent mental disorders. The drugs, the system, is being manipulated.

Put a bunch of children on courses of powerful antipsychotics, chances are their reactions to them will mimic the traits of a depressive or someone who shows a lack of interest. Solution? Feed them more drugs.

The term "chemical cosh" has been used by many people to describe these drugs, they whip the child into submission - Go and sit in the corner and be quiet, I'm not putting up with your tantrums today.

It's all well and good writing blogs about this problem or posting videos to Twitter and Facebook, chances are that only a small number of people on friend lists will retweet or share on the social networking websites. People these days seem more moved by a dog being mistreated or a cat being thrown into a bin by a passer-by. There's public outrage [and rightly so] at seals being clubbed to death or secretly filmed videos of animals being mistreated by the travelling circus. I've seen campaigns on Facebook that range from the ridiculous to the sublime and seen grown adults post links to the various games on Facebook, "You have been invited to play Mafia Wars." Hey, each to their own, whatever gets you through the day, I'm not knocking the fact that you wish to escape from reality, we all need that escapism at some point in our lives.

There are far too many shoulder shruggers, The why should it bother me, my kids are fine type. Sometimes we, as adults, have to step out of our own bubbles to see the true state of humanity. Yeh, it sucks, it's depressing and why should we take on other people's problems when we have so much crap in our own lives?

Nice take on life folks.

There are those that do then there are those that sit back and watch those that do. "You are doing great work", "Thanks for highlighting this", "Thanks for posting, I'll read after I have planted the seeds in my garden on Farmville."


I'm of the opinion that the people that highlight these stories about the ever-increasing drugging of children do not want the thanks, they'd much prefer people to do something about it. Recognition is nice but what is it worth if your message gets lost amidst the back-slapping and high fives? By all means thank those that highlight these stories but please remember what you are thanking them for then ask yourself what you can do about the reason why you thanked them.

There is a trend for those that do, they never stop at one story, they continue to highlight the plight of children being drugged because they know they have to. Repetition is the key.

Next, we have the haters. Those people that just don't like to see good triumph over evil, the anonymous knuckleheads who are so hellbent on discrediting that they fail to realise that they are no better than the white-coated buffoons that hand out these drugs, the pharmaceutical companies that manufacture them and the independent bodies that, apparently, regulate them.

Yesterday saw me join a bunch of folk for a demonstration in my hometown of Birmingham. It was to protest against the use of ECT, otherwise known as Electroconvulsive therapy. Two incidents that struck me were thus:

Scene: Standing outside Maple House where there was a symposium for psychiatrists who were gathered to discuss the benefits of ECT.

A psychiatrist, who bore a striking resemblance to comedian Billy Connolly, came outside for a cigarette break, he couldn't help but look in the direction of the protesters as we were only about 5 yards away from him. He, like so many before him, had the usual smirk on his face, the patronising kind that suggests that he knows best. He looks toward our direction and says, "So, I hear you are Scientologists", then exhaled cigarette smoke in one of those laughing fashions. "Well, I'm not", I replied. His bottom lip quivered, he shuffled, shrugged his shoulders and eventually said, "Good for you." Hey great Mr Psychiatry man, if you are going to make a broad statement toward a crowd then, at the very least, have some form of defence if you are wrong. Then again, they do like to label people eh?

Scene: Standing around the corner from Maple House holding a banner.

A member of the public stops and asks me what ECT stands for. I explain and he shakes his head before coming back with, "I thought they stopped doing that in the age of the witch.". He then walked away, hopefully better educated for that brief minute we spoke.

Two incidents, two very contrasting points of view.

One has to throw a stone to get the pool to ripple, I do my bit and many other bloggers out there do the same. The Citizen's Commission on Human Rights [CCHR] have been doing it for many years, their stones being boulders. They don't stop at isolated cases, they add more coal to the fire because the train track is never ending, boy, do I know that feeling.

This post isn't about singing the praises of CCHR, they pretty much know how I feel about their organisation. This post is one that wishes to tap into the conscience of those that feel that there IS a problem but there isn't much they can do about it. They are wrong, they need to start making the pool ripple because psychiatry, the pharmaceutical industry, medicine regulators and those haters will continue to induce harm to children around the world.








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Rise In Antipsychotic Drugs Taken By Children

Last week Channel 4 News aired a special report regarding the prescribing of antipsychotics to children.

For those that didn't get a chance to see it, now's your chance.

 

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MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine

Following on from parts I & II, today I'm covering the withdrawal effects advice given to clinical practitioners by the MHRA. You will note that I refer to it as withdrawal whilst the MHRA add [in brackets] the word "discontinuation," it's almost as if they are explaining the word withdrawal to clinical practitioners, as if they didn't know what the word withdrawal meant! Then again, the pharmaceutical line is "discontinuation" so no surprise that the 'impartial' regulator should go against their paymasters. I'm not convinced the MHRA are behind this at all. Read on.

Section - Principal Risks - Page 7

SSRI learning module: Withdrawal (discontinuation) effects


The MHRA relay the following information to clinical practitioners:

Withdrawal effects may occur, particularly after abrupt discontinuation of SSRI treatment. Patients most commonly report dizziness, anxiety, insomnia and vivid dreams, tremor, paraesthesia, headache, nausea, and lethargy. Other symptoms may also occur including, vomiting, ‘electric shock’ sensations, ’flu-like symptoms, agitation, emotional lability, and confusion. 

I am now convinced that the MHRA's SSRi Learning Module is in fact not the MHRA's at all. I'll go out on a limb here and state, for the record, that it is my belief that this module was either put together by the pharmaceutical industry or was heavily influenced by them.

"Discontinuation", "Emotional lability"?

You notice how they painstakingly inform doctors that withdrawal also means "discontinuation" yet fail to explain to doctors what "emotional lability" actually means..

Nothing like spin coming from a regulator who, at the end of the day, is supposed to be looking after the welfare of patients.

What the MHRA do not inform the unsuspecting clinical practitioners is that the term "emotional lability" covers a wide-ranged of emotional changes, including suicidal thoughts. Very convenient that the MHRA should leave this particular adverse event out considering the number of SSRi incidents associated with deaths that have been reported to the MHRA via their yellow card reporting system..

So, they inform the clinical practitioners about withdrawal effects [minus the suicidal thoughts] - what advice do they recommend?

This is the pure genius of the MHRA/Pharmaceutical industry at work..


Risk-reduction measures

On commencing treatment with SSRIs, the patient should be advised as with all psychotropic medicines to consult their clinician before suddenly reducing or stopping the dose.

When planning to end SSRI treatment, clinicians should reduce the dose gradually in staged intervals over at least four weeks (some patients will require longer) and review the patient for symptoms of withdrawal.

Treatment 

Symptoms after sudden SSRI discontinuation usually last about one to two weeks and then resolve spontaneously, but they can persist for longer in some patients. Close clinical observation is required to ensure that withdrawal symptoms are not getting worse. Severe cases may call for specialist advice and possible switch to an SSRI with longer half-life before gradual tapering.

"Discontinuation lasts usually about one to two weeks" - Bullshit!

"...but they can persist for longer in some patients." - How long?


"Close clinical observation is required to ensure that withdrawal symptoms are not getting worse." - How close, is it being suggested that the clinical practitioner move in with their patient to monitor them? Define close?


"Severe cases may call for specialist advice..." - Name the specialists, what training have they had, who have they been taught by?


"...possible switch to an SSRI with longer half-life before gradual tapering." - Round and round a garden, like a teddy bear...


It would appear that the so-called minority who get the worst out of these drugs are being ignored in favour of the supposed majority who can withdraw from an addictive medication apparently at the drop of a hat. The fact that many thousands of patients have been taking these drugs for 5 years plus does not seem to be important enough to mention to clinical practitioners, just the same old company line spewed out so many times by pharmaceutical spokespersons defending their drug's withdrawal problems, "Discontinuation usually last about one to two weeks." The addition of the line, "but they can persist for longer in some patients", is a throw away comment with no offer of a; an explanation and b; help. Severe cases may call for specialist advice? Name me one GP in Britain who knows of a specialist who is expert in the field of SSRi withdrawal. I can think of one but I bet my left testicle that a good majority of family doctors have never heard of Professor Healy [and I say that with respect]

It was Healy who met the MHRA back in 2009. It was the MHRA who clearly stated, "MHRA thanked Prof Healy for attending the meeting and agreed that it would be important to keep in contact on important new evidence in this area."


FACT:


Since that 2009 meeting the MHRA have made no effort to contact David Healy.


So who are these "specialists" that can offer 'severe cases of withdrawal' advice?

They don't exist, they exist only in the minds of the creators of the SSRI Learning Module. Unless of course the MHRA can provide me with a list of specialists experienced in SSRi withdrawal that are available on the NHS?

Well, it's in black and white so I guess I can ask them. [request sent]

I was going to cover more of the SSRI Learning Module but I see little benefit it counterpointing what the pharmaceutical industry have to say, they are more powerful than I and have so much more money to throw at the promotion of their drugs and they have a huge advantage by having the people that are supposed to protect patients on board their gravy train.

It's apparent that all the consultations the MHRA has had over the years with stakeholders has meant nothing. Once again they ignore the huge problem of SSRI withdrawal. Simply recommending alternatives and specialists that don't exist is clearly an agency shirking its responsibility, simply because they do not know how to deal with this problem, they never have...they never will.

Hats off to the creators of this module. You have created a genius work of fiction [probably ghost-written] with characters [specialists] and solutions [alternatives] that are merely ghosts in your well-oiled machine of denial.

The SSRI Learning Module can be read in its entirety HERE






Previously in this series:

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I 
MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"

Following on from Part I , today I assess more of the MHRA's SSRi Learning Module for clinical practitioners throughout the UK.


SSRI learning module: Sexual dysfunction



The MHRA write:

Sexual dysfunction is a common reason for the patient to discontinue SSRI treatment. Sensitive and frank questioning and discussion of sexual side effects during medication review can help promote adherence to treatment. 

Their advice to clinical practitioners:

Sexual counseling may be called for and specific treatment for erectile dysfunction can be considered. If symptoms persist, consider reduction in dose or alternative treatment.

There they are again banging on about "alternative" treatment without actually mentioning what that alternative treatment is.

No surprise, from me at least, that the MHRA are recommending specific treatment for erectile dysfunction. My only surprise here is that they didn't actually name the actual drug.

Back in 2009 I wrote a blog about how the MHRA had teamed up with Viagra manufacturers Pfizer to air a series of ads on national TV and also in cinemas across the UK. The ads warned of the dangers of purchasing medication online. The commercials showed a man opening a package which contained a packet of pills, he opened the pills, swallowed one then seconds later is seen pulling a dead rat from his mouth. The purpose of these 'public safety' commercials was to warn the public that buying drugs online was dangerous.

I was kind of skeptical about the whole exercise and saw it more of a promotional tool for Viagra, allbeit by proxy as it is illegal to advertise prescription drugs in the UK.

Here's the Ad.

This wasn't the first time advertising by proxy had hit UK TV screens. The following ad promoted the website 40over40.com, a website sponsored by Eli Lilly and Company.

I pondered complaining to the MHRA but it seems they had already received a complaint about this particular ad, a complaint that they did not uphold!

Is it just me or can others see a different reason behind the MHRA recommending erectile dysfunction drugs to patients... who, let's face it, have only got erectile dysfunction because of the SSRi medication they were prescribed, a medication given the all clear by the very same people who are now trying to educate doctor's about their dangers.

[Insert laughter here]


Page 6 of the SSRi Learning module - SSRI learning module: Other common adverse effects.


The MHRA write:

Sweating may occur and in some patients can be profuse. Some patients may experience numbness or tingling (paraesthesia), pain in joints (arthralgia) or muscles (myalgia) or muscle cramps.

and their risk reduction measures...

Profuse sweating may indicate that the dose of SSRI is excessive. If symptoms do not improve, switching to another SSRI may resolve the adverse effects.

I scratch my head at this logic. What is the point of switching to another SSRi when all SSRi's may cause the above? It's hardly reducing risk, it's more of a 'put the patient on a carousel and watch him/her go round and round until they eventually fall off'.

I love the use of the word "may". In truth, they just don't know, it's guesswork and poor guesswork. Switching to another SSRi can cause a whole heap of problems...something the MHRA fail to mention in this section of the "Learning" module.

Coming up in Part III - SSRI learning module: Withdrawal (discontinuation) effects.


I'm going to need a few hours to assess that particular advice!


In the meantime, keeping to the theme of erectile dysfunction, here's a video to enjoy. Courtesy of the double entendre masters AC/DC.






If clinical practitioners are going to be re-educated on the dangers of SSRi's, the last people I'd want teaching them would be an agency wholly funded by the pharmaceutical industry. - Bob Fiddaman


Previously in this series:


PART I




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MHRA To 'Re-educate' UK Doctor's on SSRi's Part I

SSRi problem?

What problem?

One would think that the British drug regulatory agency, the MHRA, would eventually admit there was a problem with SSRi's, so much of a problem that the risks of prescribing them outweigh the potential benefits of taking them.

Now, after years of being bombarded with yellow cards, anecdotal reports and meetings with SSRi patient advocates, they have decided to offer advice to clinical practitioners in the form of an "SSRi Learning Module."

Fantastic, superb, about bloody time, may be some of the terms used upon hearing this news. I agree that is a step in the right direction but, through experience liaising with the MHRA in the past, I see it as a mere 'cover our ass' type of module. The MHRA want to be seen to be doing something about the SSRi problem yet the module offers nothing that isn't already on the patient information leaflets that accompany this family of medicines.

I have to admit that browsing through the module had me shaking my head in disbelief, it's more of an industry stance than one that is impartial and protecting the consumers. It offers nothing new to clinical practitioners and appears to be yet another buck-passing operation that shows the MHRA admit there is a problem but they really do not know how to handle it.

I'd like to know where they gained their information from, particularly the section entitled "Principal Risks."

Before I dissect what I believe to be a token gesture to all those suffering SSRi withdrawal problems, I'd like to ask why this Learning Module is flying under the radar, why hasn't this been announced to the mainstream press by MHRA CEO Kent Woods? One can only assume that the MHRA don't want people like me shouting from the rooftops, "I told you so". Assumptions is all people like me are left with when a body of regulators are less than transparent.


SSRI learning module: Principal risks


The MHRA module states:

Some noteworthy risks for SSRIs are discussed in this module. Summaries of product characteristics and the BNF should be consulted for a fuller account of the risks of individual SSRIs.

The BNF is close to my heart. On 2 September 2008 I pointed out to Kent Woods that the advice given for SSRi withdrawal in the BNF was minimal. Kent, without making any promises [cover your ass stance] told me that the MHRA would approach the BNF to see if the advice could be changed. In the same meeting I also urged Kent Woods to seek the advice of an expert on SSRi withdrawal. I put forward the name of Professor David Healy. A year or so later, 26 June 2009, MHRA officials met with Healy in a meeting to discuss awareness and management of withdrawal reactions with SSRIs and related antidepressants.

To my knowledge the BNF gives no sound advice on SSRi withdrawal, three years after I asked for it. Healy's withdrawal protocol he offered the MHRA over two years ago remains on the table collecting cobwebs no doubt.

Back to the module.

Two items of note on page 1 of the 18 page module:


Pregnancy and breast-feeding:
The decision to prescribe an antidepressant during pregnancy involves very careful assessment of risks to the mother and fetus of untreated depression during the pregnancy and the risks to the fetus of adverse effects including teratogenic [1] effects from exposure to an antidepressant.

and

Overdose:
Features of overdose include the usual adverse effects of SSRIs, but very large overdoses can also lead to cardiac features (tachycardia, rhythm disorders, hypotension or hypertension), convulsions, and coma. SSRI overdosage is managed by treating specific symptoms as they arise.

It appears that the MHRA are clearly stating here that SSRi's are teratogenic. Bravo. The penny has finally dropped.

In my book, The evidence, however, is clear...the Seroxat scandal, I dedicate a chapter to my correspondence with the MHRA when I wrote them and asked a specific question, 'Is Seroxat a teratogen?' The response I got was limp-wristed at best and about as clear as mud. It took the MHRA over three weeks to give me an answer that was basically them fence-sitting.


Dear Mr Fiddaman, 


The question “Is paroxetine a teratogen?” is not as straightforward as it may appear, set the tone for what must have caused a severe case of splinters on the ass for whoever drafted it. No doubt it was run by lawyers first...and probably GlaxoSmithKline too, whom I had also contacted with the same question, their response was about as useful as an inflatable dartboard in as much that they told me to "talk to my doctor."

On overdosing, the module now admits that a large overdose may cause cardiac features (tachycardia, rhythm disorders, hypotension or hypertension), convulsions, and coma.

Here's what the MHRA wrote in 2008 [2]:

Selective Serotonin Re-uptake Inhibitors (SSRIs) are a class of medicines that have been used in the treatment of depressive illness and anxiety disorders since the late 1980s. The general adoption of SSRIs into clinical practice reflected in particular their greater safety in overdose, an important advantage in comparison with risks associated with the previous generation of antidepressants, known as tricyclic antidepressants.

Ho hum, what a difference almost 4 years make.

I'm probably being pedantic here, they never actually said that SSRi overdoses didn't cause cardiac features (tachycardia, rhythm disorders, hypotension or hypertension), convulsions, and coma back in 2008 - at least that's probably the argument they'd use in their defence today. It appears that one has to ask these questions before the MHRA answer them, they don't think it important enough to tell you first and, hey, if you don't ask then that kinda leaves them in the clear.

Page two of the module leads with...

SSRI learning module: Gastrointestinal adverse effects.


The module goes on to say that "Gastrointestinal side effects increase with the dose. Drugs that raise the concentration of SSRIs (eg cimetidine with citalopram, escitalopram or sertraline) may increase the risk of side effects. There is no specific treatment for gastrointestinal adverse effects of SSRIs. If unwanted effects do not subside over time and continue to be troublesome then dose reduction can be considered; alternatively, the antidepressant could be changed."


In other words, we don't really know so we suggest doctor's reduce or change the antidepressant. And this is a 'learning module'? Exactly what are clinical practitioners learning from this advice?

Page three moves on to:

SSRI learning module: Central nervous system adverse effects.


Here they mention the more 'common' side-effects, I beg to differ. The ones they list as being rare seem to be more prominent these days.

I'm finishing off Part I of this blog post with section 4 of the module;

SSRI learning module: Psychiatric adverse effects.


This is head-shaking stuff, yet more of 'we don't know what to suggest so we'll just put the patient on a carousel until we can figure out how to combat this problem.

They write:

SSRIs can produce an uncomfortable mental sensation of tension, restlessness or anxiety (akathisia—feeling of restlessness and inability to sit or stand still). This paradoxical state of anxiety can occur when initiating treatment. Severe agitation, psychotic symptoms and suicidal ideation are rare but these serious symptoms must be recognised and addressed.

As far as treating the above symptoms, the MHRA offer this advice:

Anxiety symptoms often settle within a few days of treatment. Regular review and reassurance of the patient may be all that is required. If anxiety symptoms do not abate, the dose of SSRI may have to be reduced. For severe and distressing symptoms use of a benzodiazepine early in the treatment may be considered but, to reduce the risk of benzodiazepine dependence, the duration of such treatment should not exceed two weeks. If symptoms persist, an alternative treatment should be considered.

What alternative treatment? Chicken in a basket, fried eggs on toast, jogging on the spot perhaps? It's all well and good offering advice to doctors but when that advice is so blatently vague it just leaves the doctor's who, like all human beings, have differing opinions on matters. If the MHRA are going to go to great lengths of an SSRi Learning module then for the love of God don't be half-arsed about it. Don't leave the doctor to make his own decision because you just don't know?

In truth, the MHRA are burying their heads in the sand. The 'alternative' treatment is not mentioned here because they don't know what the alternative treatment is - they are putting the onus on the doctor to make that call which, in my opinion, is basically a Carte Blanche for more prescription scribbling for more medication that the patient does not need. A blank cheque, if you will.

Judging by the advice given to doctors by the MHRA on patients suffering psychiatric adverse events it would appear that they are shrugging their shoulders and muttering, "Um...we dunno." They are merely disguising that 'advice' as "alternative."

If clinical practitioners are going to be re-educated on the dangers of SSRi's, the last people I'd want teaching them would be an agency wholly funded by the pharmaceutical industry. - Bob Fiddaman


Part II coming soon.






[1] Teratogenic: Able to disturb the growth and development of an embryo or foetus
 Teratogen: Any agent that can disturb the development of an embryo or foetus. Teratogens may cause a birth defect in the child. Or a teratogen may halt the pregnancy outright. The classes of teratogens include radiation, maternal infections, chemicals, and drugs

[2] MHRA Investigation into Glaxosmithkline/Seroxat


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FDA Approve Another Addictive Drug

I thought I was seeing things when I read this. The FDA, in their infinite wisdom, has just approved Intermezzo, the pill that... well, it basically knocks you out for the count.

Designed by Transcept Pharmaceuticals Intermezzo is for people who wake in the middle of the night. Slip it under your tongue and you'll be out like a light. It's basically the equivalent of stepping in to the ring with Iron Mike Tyson.

Intermezzo - nice brand name. I have a thing about brand-names, I briefly touch on it in my book.

Intermezzo is is interesting. Inter - (tr) to place (a body) in the earth; bury, esp with funeral rites. Mezzo - (a person having) a singing voice between soprano and alto. In music, an intermezzo (Italian, plural: intermezzi), in the most general sense, is a composition which fits between other musical or dramatic entities. Oh, and it's also a coffee so there may be some objections to the name at some point down the line.

The FDA had on two occasions previously refused to approve Intermezzo, their main worry being that people might get up and try to drive before the drug fully wears off. Studies clearly show that the drug badly impairs driving, and that this effect lasts longer in some people than in others. To get around this the manufacturers changed the labelling to state that the drug should only be taken when people have at least four hours of sleep time remaining. They also added, "Moreover, people should not take Intermezzo if they've been drinking alcohol or if they've taken other sleep aids."


A simple tweak of a label and the FDA give it a clean bill of health. Amazing aren't they?

The final three paragraphs from the WebMD website say it all really:

Intermezzo, like other sleeping pills, can cause serious side effects. These include getting out of bed not fully awake and being unaware of doing things or remembering you did them.

Activities reported to the FDA while under the influence of sleep medicines include driving a car, making and eating food, having sex, talking on the phone, and sleep walking. Alcohol or other sleep medicines increase the risk of doing such things.

And like other forms of zolpidem, Intermezzo is a controlled substance that can be abused or that can lead to drug dependence.

"...getting out of bed not fully awake and being unaware of doing things or remembering you did them."

Any defence lawyers out there, I feel a bank robbery coming on.

Ironically, after taking Seroxat for 6 years I now have a sleep disorder, I wake in the middle of the night and can never get back to sleep. In fact, I can fall asleep at inopportune moments too and in the past I have fallen asleep waiting to be served at a bar, on a bus and even a telephone box! Thank you GlaxoSmithKline.

Will I be sampling Intermezzo?  HAHA! Once bitten...

WHAT DO WE WANT?

A CURE FOR INSOMNIA

WHEN DO WE WANT IT?

Zzzzzzzzzzzzzzzzzzzzzzzzzzz

I'm left scratching my head at the logic of this approval. It's not a cure, it's merely papering over the cracks and I can guarantee that more cracks will appear, they always do with these drugs that act on the brain.

Nice job FDA.

GlaxoSmithKline Parodied

I do love it when a good post comes along using the art of parody to slam GlaxoSmithKline.

Two posts of note are by two separate bloggers. First off is The Truthman with the brilliantly titled blog, GSK Licence to [Kill]

The Truthman has been hard at it for years, posting relevant information relating to GlaxoSmithKline's unsavory history.

His latest post is in comic-strip form and rips a new hole into GSK CEO Andrew Witty.

The Truthman living up to his name and spreading the truth.

You can read the full comic over at The Truthman's blog HERE

Next up is one of the most consistently funny bloggers out there. Pharma Giles has been kicking ass for some time now, his latest parody is a work of genius.

You can read the full parody over at Pharma Giles' blog HERE

Keep up the great work guys. One thing I've learned during my years writing this blog is that Glaxo, the regulators and psychs hate it when you make fun at their expense.

Bravo.




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Drug Pushers Target 4 Year Old Kids

"You are depressed because you have a chemical imbalance"


"You are shy because you have a chemical imbalance"


"You are anxious because you have a chemical imbalance"


""You have ADHD because we said so"

Back in the day, when SSRi's such as Prozac and Seroxat came to market, the drug companies reeled in the consumers by telling them they had something wrong with them, a chemical imbalance was deemed to be the cause of their feeling anxious, shy or depressed. "Seroxat", we were told, "corrects that chemical imbalance."

Amazing how they actually got away with such false and misleading statements.

These days it would appear that no explanation is needed. Psychiatrists and drug companies no longer use the chemical imbalance fact...because it never was fact. If they do tout the chemical imbalance theory at you then I recommend you watch the short video at the end of this post for a suitable response to them]

Today sees drug companies advertising by proxy. Key opinion leaders, better known as leading psychiatrists in the world of pediatrics, do the pushing for them. They promote illnesses such as ADHD then announce that there is a cure...in the shape of a pill. Because there are no advertising guidelines for a psychiatrist's opinions they can say pretty much what they want to without backing up their claims with any scientific data.

Apparently it's heredity that is one of the causes of ADHD. That's right folks, if you were a little boisterous in childhood then chances are that your offspring will be born mentally ill.

Now, I wasn't the model pupil in my schooldays, quite the opposite in fact. I kind of questioned what was being taught, it was confusing to be told in history lessons that we derived from apes yet an hour or so later, in Religious Education , I was told that we were created in the image of God. "So God looks like an ape, right?", I'd ask. This was usually greeted with the cane or a detention or in some cases I was told to seek confession for my sins. The sin of an inquisitive mind - where's that in the Bible?

There were lessons where I would get bored so I'd craft paper aeroplanes or flick paper pellets with an elastic band. Then there were the times of puberty when all I could think of was mattress dancing with any of the girls whose eyes I happened to meet. This, in turn, would have me day dreaming out of the window and thinking of The Bionic Woman [Lindsey Wagner] or tennis ace [Chrissie Evert]

Nowadays such behaviour would be deemed as something only a mental child would do and I'd probably be carted off to the headmaster [straightjacket affixed] and be sent home on the proviso that I met with my GP to discuss my 'abnormalities'.

Puberty huh, such an imbalance on the brain.

Today, it seems, kids can have a mental disorder before they attend their senior schools, in fact before they attend their primary schools...which leads me nicely to a recent article published in today's Telegraph.

The headline reads "Give Ritalin to four-year-olds with ADHD, say experts." The article, by Stephen Adams, reports on how the American Academy of Pediatrics [AAP] claim, "Treating children at a young age is important, because when we can identify them earlier and provide appropriate treatment, we can increase their chances of succeeding in school."

He [Dr Mark Worlaich, professor of paediatrics at the University of Oklahoma College of Medicine] and colleagues, writes Adams, advised that a doctor "should initiate an evaluation for ADHD for any child four through 18 years of ago who presents with academic or behavioural problems and symptoms of inattention, hyperactivity, or impulsivity".

Ah, I see. So, four year-olds who are not interested in learning the alphabet or reading along to Thomas the Tank Engine stories are actually mentally ill?

WAY TO GO Mr Pediatric man!

You know, it would be great if you could give 4 year-olds a leg up to childhood rather than drug them and turn them into a dribbling mess. Interestingly, the AAP came under fire, albeit moderately, from Dr John Houston, a consultant paediatrician based at Lorn and Islands Hospital in Oban, who said, "In the UK we are more reluctant to medicate our kids, and I think that's a very good thing."

Reading between the lines it would be nice to think that Dr Houston was telling the AAP to head on back to America with their delusions. Sadly, it's the opposite as more and more UK doctor's have bought into the idea that normal behaviour [daydreaming, tiredness, being boisterous] is now treatable with mind altering drugs.

I can't wait for their day of Judgement.

This post is dedicated to Chrissie Evert and Lindsey Wagner, whom collectively made my childhood and teen years so much more pleasurable than any doctor today thinks they can.






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OR UK FROM CHIPMUNKA PUBLISHING

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GlaxoSmithKline's Cervarix Under The Spotlight [Again]

Fresh from paying off a recent fine of $3 billion for illegally marketing it's brand of drugs, Paxil, Wellbutrin and Avandia, pharmaceutical giants, GlaxoSmithKline, were yesterday embroiled in another tale of woe regarding another of their products.

This time it's their widely promoted safe vaccine for teenage girls, Cervarix.

Many of the British newspapers are covering the story of Lucy Hinks who, at the age of just 13, has been left in a "waking coma" after suffering suspected side effects from the Cervarix vaccine.

Glaxo, in usual style, have rolled out the tired and trusted one-liners that has stood them firm for years when defending drugs such as Avandia and Seroxat.

This from MSN News:

"It [Cervarix] has been shown to be generally well tolerated".

and the old faithfull:

"...we take these reports very seriously."


Ring any bells?

2002 [BBC] GlaxoSmithKline spokesperson Alastair Benbow defending Seroxat with:

"Seroxat is an effective and generally well tolerated treatment for the management of depression."

Or

"We take the safety of our medicines extremely seriously." - Transcript GSK Tape – Panorama Interview – Dr Alastair Benbow 9 October 2002


Personally, I think the comments from GSK spokespersons are being generally well tolerated by the British public, be nice if we had some transparency occasionally, doncha think?

In June 2008 a promotional DVD was sent to every G.P in the UK just hours before the launch of the Cervarix vaccine in the UK. The DVD was posted with the G.P. magazine and was a clever marketing strategy aimed at busy G.P.'s to 'brainwash' them into believing that the Cervarix vaccine protected young women from the perils of cervical cancer.

The comments at the start of this video juxtapose the claims made by GSK in the promotional video.



For more information:

http://sanevax.org/ 
http://www.americanchronicle.com
http://vactruth.com/