Zantac Lawsuit


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

Monday, August 31, 2009

The Waltons - The Lost Episode - "John Boy Is A Dysfunctional Scientologist"

For the background on this story read the following links at the bottom of this post.





The Mothers Act Disease Mongering Campaign - Part I


The Mothers Act Disease Mongering Campaign - Part II


The Mothers Act Disease Mongering Campaign - Part III


The Mothers Act Disease Mongering Campaign - Part IV


The Mothers Act Disease Mongering Campaign - Part V


Pro-Antidepressant Brigade Use Scientology As Their Defence.

Fid

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Pro-Antidepressant Brigade Use Scientology As Their Defence.

It does seem rather odd to me that individuals who appear to promote the use of antidepressants like to label anyone against antidepressants as 'Scientologists'.

It's an old ploy to discredit. Quite why they use Scientology is unknown - to be honest I'd be more offended if they labelled me as a follower of any of the mainstream religions.

I am not even sure if Scientology can be deemed as a religion as such - do they worship a God?

For the record, I'm not affiliated with the Church of Scientology and even if I was would it make my opinion any less valuable than that of a Christian or Muslim?

Evie Pringle's recent series of installments regarding the Mother's Act has shown the lack of defence in the pro-antidepressant brigade. Scream out against the use of antidepressants and the defenders scream back 'SCIENTOLOGIST!'

Imagine years ago if one was to speak out against mind-bending drugs. DON'T LISTEN TO THEM, THEY ARE A CHRISTIAN, A MUSLIM! [delete where applicable]. Ironic really that the aforementioned 'religions' have been the cause of endless bloody wars. This post is not meant as a slur on religion - each to their own. Does a super power exist? I don't know. Do I care? No.

It's absurd and, it seems, the only defence of the pharma whores, because that's what they are.

There are no better critics of antidepressants than those who have taken them and experienced the adverse effects of them. To dispel what this group of people have to say smacks of ignorance and stubbornness. Can you imagine a patient telling his doctor that the drug they are taking is causing diarrhea and the doc telling them that they only think it's the drug when in fact it's probably down to their connections with Scientology!

The pro-antidepressant brigade seem to have cleaned the cobwebs off their broomsticks lately after Evie Pringle's 5 part installment - 'The Mothers Act Disease Mongering Campaign.'

Part 4 of Evie Pringle's series highlights this coven of individuals. Evie refers to them as the 'A Team' and writes:

"In review, the main leaders of the Mothers Act disease mongering campaign include Susan Dowd Stone and Karen Kleiman, two social workers who own treatment centers recruiting customers via their websites, PerinatalPro and Postpartum Stress Center, and who also sell books. The two most prominent "victims" or "human faces" in the campaign are Katherine Stone with the "Postpartum Progress," website and Lauren Hale with a site called "Sharing the Journey."

All the websites follow the lead of a group called, "Pospartum Support International," and parrot the buzz words and phrases invented by the self-interested specialists and experts, such as "women's reproductive mental health," and "pregnancy related mood disorders," and "reproductive psychiatry.""

"The Mothers Act campaign has now taken aim at new fathers", writes Pringle. She continues, "All the gals provide links to the "PostpartumMen," website. And in return, PostpartumMen dedicates a whole webpage to promoting the Mothers Act, complete with a link that takes readers directly to the website of Susan Stone's treatment center."

PostpartumMen is a website for men with concerns about depression, anxiety or other problems with mood after the birth of a child. Oh, if only they were around back in the old days when father's worked their fingers to the bone down some dark shaft digging for coal so he could provide for his family. If only the blackened, tired father, who emerged from exhausting shifts down the pit could have had the opportunity to visit PostpartumMen.

We have come a long way since the days of exhausting shift work down holes where one could barely breathe but in the world of Mental Health it seems they see progress as a chance to promote drugs.

PostpartumMen offers men the chance to see if they have Postpartum Depression [PPND]. Men are invited to participate in a research study conducted by Dr. Will Courtenay. To be honest I was going to take the test and base it on how I felt 23 years ago when I had my first child but I became bored very quickly of the questions and kind of knew where they were leading. One of the True/False questions was eye opening though - "If taking medication to help me be a better father, I'd do that TRUE/FALSE. Dr. Will Courtenay is also the Registrant of PostpartumMen.com and also hosts the following websites, the majority of which are still under construction:

Mens Depression
Helping Men Beat Their Silent Killer


Mens Therapy
Helping Men Overcome The Problems Mixed Messages About Manhood Create


Help for Nice Guys
When Just Being “Nice” Isn’t Working Anymore


Men’s Health Consulting
Promoting Better Health and Welness In Men and Boys


Help For Angry Men
When You’re Ready To Become The Man You Know You Can Be


PPND surfaces again and Courtney claims it, "is a very serious condition," he adds that, "it's also a very treatable condition."

It's hard to decipher whether or not Courtenay advocates the use of antidepressants. One thing, the guy is making money for his services - therapy for father's who are merely experiencing parenthood.

It's a huge spider's web and if one is to be unfortunate enough to become tangled within then expect the big, bad spiders to come and gobble you up. Lucky for them, they have 8 limbs to hold aloft the 'YOU ARE A SCIENTOLOGIST' placards and bite with venom at anyone who dare question their ethics.

Pharma want your children, they want their mother's and now, it seems, they want the very seed of life itself.

Pharma has more cult members than Scientology apparently does and if Pharma was a living entity it would have been executed years ago. Instead, it continues to thrive, it recruits and doctronizes with money and when its disciples are called to task they act in a way that is akin to many of the religious fanatics we see on our daily news bulletins. Scream, "CONFLICT OF INTEREST" and expect those with interests to scream back, "SCIENTOLOGIST". It's the only weapon they have.

My Internet stalker has labelled me a Scientologist, for some reason they think this blog is funded by the Church of Scientology. I wish someone would fund it because I'd be able to pay my bills on time and buy a packet of cigarettes occasionally

Evie Pringle's 5 part installments need to be read from start to finish. She has cast out the line and, it appears, someone has took the bait.

Reel em in Evie.


The Mothers Act Disease Mongering Campaign - Part I


The Mothers Act Disease Mongering Campaign - Part II


The Mothers Act Disease Mongering Campaign - Part III


The Mothers Act Disease Mongering Campaign - Part IV


The Mothers Act Disease Mongering Campaign - Part V


I was tempted to sign off this post as L. Ron Hubbard to give the pharmaceutical whores ammunition to throw back at me. Hey, if people like Joseph Beiderman think they are God then I can play with fiction too, can't I?

Fid

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Sunday, August 30, 2009

SSRi's - "DO NOT STOP ABRUPTLY"

We are warned by the patient information leaflets and by the regulators to not stop SSRi treatment abruptly.

It would be nice if we had a choice!

Monday, 24 August 2009

Concerns over vital drugs shortage

Shortages of certain medicines is causing patients "extreme distress" and even seeing them admitted to hospital, pharmacists have warned.

Of more than 150 community pharmacies surveyed, nearly a third said patients had suffered because they had difficulty sourcing medicines including those for breast cancer, blood clots and anti-depressants.

One pharmacist reported that a patient had panic attacks waiting for the anti-depressant Cipralex, and another said the wait for the breast cancer drug Femara had caused "extreme distress".

In another case, a shortage of the blood clot drug Plavix had contributed to a hospital admission, it was claimed.

More HERE

Hat-Tip - Janice Simmons

Fid

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Friday, August 28, 2009

The SSRi Road To Hell by Bob Fiddaman

I have previously wrote about Pfizer's anti-smoking [mind-warping] drug, Champix [Chantix in the US], where I had learned that both the Federal Aviation Administration [FAA] and the Civil Aviation Authority [CAA] had banned this particular drug for use in their pilots and Air Traffic Controllers [ATCO's].

It came as no surprise to me seeing as Champix can cause some pretty nasty side-effects, some that could basically turn those prescribed it into a raving lunatic.

It got me thinking. If Champix was banned for use in our pilots and ATCO's then what of other mind-altering drugs such as SSRi's?

It's two-fold really. Who would want to fly with 'Loony Airlines' whose pilots and ATCO's are drugged up on SSRi's? And being treated for an illness that needed SSRi's has to come into the equation too... unless of course they had been given an SSRi for premature ejaculation - no problem with a pilot who arrives to quickly in my book.

I wrote back to the CAA and also made a fresh request to the MHRA.

Have pilots and ATCO's been banned from taking Seroxat and other SSRi's?'

The answer is a resounding Yes. This from Jill Vening, Senior Aeromedical Adviser, CAA, Gatwick:

"Dear Mr Fiddaman,

Thank you for your e/mail query regarding Seroxat & pilots/ATCO's. I can confirm that the UK CAA does not permit this medication or any other of the SSRI group of drugs and psychotropic medication in general to be taken whilst holding a valid medical certificate. This is because of the side effect profile and the condition for which it has been prescribed."


Short and sweet but transparency at its best.

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The Mothers Act Disease Mongering Campaign - Part IV

Read Evie Pringle's next installment - 'The Mothers Act Disease Mongering Campaign - Part IV'.

Here's a segment that will have you wondering just who is in control...or rather who wants that control.

Sad Daddies

As part of this overall disease mongering scheme, the Mothers Act campaign has now taken aim at new fathers. All the gals provide links to the "PostpartumMen," website. And in return, PostpartumMen dedicates a whole webpage to promoting the Mothers Act, complete with a link that takes readers directly to the website of Susan Stone's treatment center.

"PostpartumMen is a place for men with concerns about depression, anxiety or other problems with mood after the birth of a child," according to its website.

Dr Will Courtenay runs the site. Courtenay is a Licensed Clinical Social Worker and has served on the clinical faculty in the Department of Psychiatry at Harvard Medical School, and the University of California, San Francisco, Medical School, according to his bio.

"Yes, men do get postpartum depression," he writes on PostpartumMen.

"It's a fact that most people – and even many health professionals – don't know," he claims.

"Depression, anxiety or other problems with mood can occur anytime during the first year of your child's life," he tells men.

"The truth is, depression, anxiety and other mood disorders are common," he states. "In fact, they're just as common – and just as real – as physical problems, like heart disease and diabetes."

"It really pains me to see so many men suffering alone, in silence," Courtenay says on PostpartumMen. "Especially since depression, anxiety and the other mental health problems that afflict us are treatable."

For men, the newly coined disorder is called "paternal postpartum depression," and referred to as "PPND."

"Up to 1 in 4 new dads have PPND," Courtenay tells readers on PostpartumMen. "In the United States alone, that amounts to 2,700 new fathers who become depressed every day."

And as it turns out, Courtenay hosts a total of six websites for men, accessible with live links from PostpartumMen, including one for his "Men's Health Consulting," firm.

In advertising for this firm, he provides a webpage on, "Media Coverage of Dr. Will Courtenay," and posts selective remarks and comments made regarding himself or PPND and men.

For instance, this description of himself was listed as coming from Newsweek: "An expert on why fathers can also become depressed after the birth of a child, and what couples can do about it."

Read the whole article - it will have you uttering profanities under your breath. This is not Hollywood folks - this is real. Pharma are running the show.

Fid

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Thursday, August 27, 2009

Madness Radio: Paxil [Seroxat] On Trial Alison Bass - The Podcast




Source: Madness Radio

When GlaxoSmithKline was caught lying about the risks of its blockbuster anti-depressant Paxil [Seroxat], it set off ongoing investigations. How did New York state take on one of the world's most powerful companies? Was NY Governor Eliot Spitzer driven out by his corporate enemies? Pulitzer-nominated Boston Globe journalist Alison Bass, author of Side Effects: A Prosecutor, A Whistleblower, And A Bestselling Antidepressant On Trial, discusses legal battles to clean up drug company corruption, including pay-offs to the National Alliance for the Mentally Ill.

Duration: 51:47


If you have not read Alison's book yet then I recommend you do. It's a fascinating read and highlights how far GlaxoSmithKline went to suppress information regarding their best-selling antidepressant drug Paxil/Seroxat.

Fid

Madness Radio: Voices and Visions From Outside Mental Health is a weekly FM show produced through WXOJ-LP in Northampton MA, aired on KWMD in Anchorage Alaska. Madness Radio is syndicated through the Pacifica community radio network and shows are picked up by stations around the country and internationally.

Here is a list of their Latest Shows

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Tuesday, August 25, 2009

Recent paroxetine Literature

Reading through this recent paper [Paroxetine-induced increase in LDL
cholesterol levels] it appears that paroxetine [Seroxat] can significantly increases your LDL [bad] cholesterol level.

“A similar 9% paroxetine-induced increase in LDL-C observed in the large number of psychiatric patients suffering from comorbid established CHD would be detrimental from a cardiovascular perspective and would oppose the new NCEP therapeutic goals of decreasing LDL-C levels by 30–40% in high and moderately high-risk patients.”

Venlafaxine [Effexor] is also mentioned in the paper:

"A double-blind, randomized, placebo-controlled efficacy study comparing the efficacy of short-term administration of paroxetine, venlafaxine and placebo in patients with social anxiety disorder (SAD) found that paroxetine and venlafaxine, a serotonin and norepinephrine reuptake inhibitor, induced a statistically significant rise in total cholesterol, but the increase in LDL-C did not reach statistical significance (Liebowitz, et al., 2005)."

Two antidepressant drugs - both with a high number of adverse reaction reports.

Both remain on the market.

The paper can be downloaded here.

Fid

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Podcast from Shelley Jofre BBC Panorama

Podcast from Shelley Jofre BBC Panorama speaking at Coventry University UK.

Shelley has taken on the likes of GSK, The MHRA - Confronted the patronizing Martin Keller.

She has grilled MHRA Chairman, Alasdair Breckenridge, put GSK's Head of European Clinical Psychiatry, Alastiar Benbow, on the spot ["We haven't got a licence in children yet"]

In this Podcast, Shelley discusses the four Panorama programmes where Seroxat was highlighted.

We all owe a great deal of thanks to Shelley - The decline in Seroxat prescriptions since the airing of her investigative programmes is not a coincidence.

This blog gives Shelley a 21 gun-salute.

You rock!





Fid

Buy the book - The evidence, however, is clear...the Seroxat scandal.

US - HERE
UK - HERE

FDA probes liver damage with Glaxo'sl Alli




August 24th [SOURCE]

The Food and Drug Administration is investigating reports of liver damage in patients taking alli, the only nonprescription weight loss drug approved by the agency.

Read more HERE




Fid

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Monday, August 24, 2009

NEW SEROXAT VIDEO AND AUDIO BLOG

http://seroxatvideos.blogspot.com/

Fid

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The Pharmaceutical Redemption



Fid

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Sunday, August 23, 2009

Victorious England regain Ashes






Congratulations to England on regaining the Ashes.

Fid

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Saturday, August 22, 2009

ABILIFY - LIKELY TO DRIVE YOU INSANE!

With more and more reports coming in of adverse reactions to SSRi's such as Prozac and Seroxat and non-SSRi's like Effexor, you may be surprised to learn that ABILIFY is designed to help people already on antidepressants!

According to the advertisement, 2 out of 3 people being treated for depression still have depression symptoms.

If it wasn't so serious this would be laughable. I'm scratching my head at ways to write about ABILIFY. The marketing defies all belief - it's basically saying 2 out of 3 people on antidepressants are... um...still depressed and because they are still depressed they need more drugs on top of the one's they are already taking. In other words - a chemical lobotomy.

Don't worry though folks, the advertisement carries the reassuring news that ALBILFY is FDA approved to treat depression in adults when added to an antidepressant [such as Lexapro, Zoloft, Effexor XR or Paxil CR]

The ad shows a young woman staring into space with the words, "I'm taking an antidepressant, but I think I might need more help"

Then comes the money line:

"Approximately 2 out of 3 people being treated for depression still have depression symptoms. If an antidepressant alone isn't enough, talk to your doctor. Your options may include adding ABILFY to the antidepressant you're already taking."

It's an advertisement that raises bile and gives you a taste of vomit in the mouth, it's akin to giving the owner of a gun an extra bullet - just in case the 6 bullets they already had, didn't do the job!

I'm not astounded anymore. Pharmaceutical companies are literally getting away with murder - the regulators [enforcers] are allowing them to.

ABILIFY is a product of Bristol-Myers Squibb.



Fid

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Friday, August 21, 2009

SEROXATBUSTERS


Feat. Ali Benbow [GSK] & Ali Breckenridge [MHRA]
Special Guest Appearance by Shelly 'Ankle Biter' Jofre [BBC]


Mixed By Bob Fiddaman

Fid

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Passenger Safety - The Champix Scandal

Special thanks to Janice Simmons of the Seroxat User Group for bringing this to my attention.





What is Champix?

Pfizer's Champix tablets contain the active ingredient varenicline, which is a medicine used to help people who are addicted to nicotine to give up smoking. It acts in the brain, but is not the same as nicotine replacement therapy.

*There have been reports of suicidal thoughts or behaviour in people taking this medicine to help them give up smoking.

Although Chantix [Champix] has never been classed as an antidepressant it does have some indirect actions on dopamine, which is a neurotransmitter that some anti-depressant medications work on.

This article throws further speculation on Chantix.

"I had a feeling that once varenicline started to be widely prescribed, that patients might start reporting to their doctors that they felt less depressed,"says Marina Picciotto, a professor of psychiatry at Yale University.

Chantix is a partial agonist of the nicotinic acetylcholine receptors, which means that it both stimulates them and blocks them simultaneously — like cupping a hand over a button while pressing it gently.

"The potential of nicotinic partial agonists for treatment of depression has not been formally evaluated in humans, Says Tony George. "But, I think there is lots of evidence to speculate that such a mechanism might be therapeutic in depression at least as an adjunct to standard antidepressant treatments."




In 2008 the Federal Aviation Administration [FAA] took the unusual step of banning the use of varenicline [Champix] after it learned the anti-smoking medicine might lead to safety problems, it ordered pilots and air traffic controllers to stop taking it immediately. Strangely it is called Chantix in the USA.

The FAA took this action one week after a medical safety group, the Institute for Safe Medication Practices, released the results of a study that found evidence for the occurrence of seizures, loss of consciousness, heart attacks, vision problems, and various psychiatric instabilities in individuals who use Chantix.

In November 2007, the FDA began to receive reports of psychiatric problems associated with the medication. The FAA’s Federal Air Surgeon Fred Tilton said he was aware of the anecdotal information circulating about Chantix, but chose to rely on hard data as it became available. “There were indications, but no clear data,” he said. “We don't just act indiscriminately.”

When more conclusive data was published, Tilton's Office of Aerospace Medicine moved quickly in response. [Source]

On July 10, 2008, The Washington Times reported that the Department of Veterans Affairs watchdogs concluded that the department failed to alert veterans suffering from post-traumatic stress disorder in a timely manner to the dangers posed by a drug it was prescribing. That drug was Chantix.

The Food and Drug Administration [FDA] approved the Pfizer's drug for sale in 2006, and the FAA first approved Chantix for pilot and controller use in July 2007.


So what of the UK aviation authority - have they banned Champix? [Chantix]

I wrote to The Civil Aviation Authority, the UK's specialist aviation regulator, and asked them if Pfizer's Champix had been banned in Pilots. Dr Paul Collins Howgill, Head of Aviation Medicine Training at Gatwick wrote back the following resonse:

Dear Mr Fiddaman

Thank you for your email of the 15th August concerning Varenicline.

I can confirm that the United Kingdom CAA has not permitted pilots or air traffic controllers to take this drug whilst holding a valid UK CAA issued medical certificate. This is because of the side effect profile.

We are also aware that although the FAA initially allowed this drug to be taken by pilots and air traffic controllers certificated by the FAA, they subsequently withdrew this approval.

I am unsure as to what the regualtory policy is in other National Aviation Authorities within Europe.

Kindest regards

Dr Paul Collins Howgil


If Champix/Chantix has been banned for use in pilots and air traffic controllers then one could assume that train drivers and controllers and possibly bus/coach drivers would be told to abstain from this particular drug too?

I contacted the relevant departments - as yet I have received no response. I hope Champix has been banned for use in drivers/operators of public transport, if it hasn't then it begs the question, why?


And what of Pfizer, the manufacturer of Chamtix? Here's the Patient Information Leaflet for Chantix [US].

WARNINGS

Neuropsychiatric Symptoms and Suicidality

Serious neuropsychiatric symptoms have been reported in patients being treated with CHANTIX (See Boxed Warning, PRECAUTIONS/Information for patients, and ADVERSE REACTIONS/Post-Marketing Experience). These post-marketing reports have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide.

In the UK it is known, confusingly, as Champix. Here's the UK patient Information Leaflet

4. POSSIBLE SIDE EFFECTS

"There have been reports of heart attack, hallucinations, depression, suicidal thoughts and hypersensitivity reactions (such as swollen face or tongue) in patients attempting to quit smoking with CHAMPIX."

Hardly the strongest of warnings compared to the US Patient Information Leaflet is it?

In fact two lines stating that there have been reports would hardly deter a doctor from prescribing it.

The difference in the warnings is staggering:

US WARNING: Which is at the very top of the PIL [Fig1]



UK WARNING: Which is listed within the 'Uncommon side effects' section. [Fig2]



Quite a contrast. It makes one wonder if Champix should carry a government health warning the same way cigarettes do here in the UK. In fact images of lung cancer and other smoking related diseases now appear on packets of cigarettes - maybe Pfizer should add images of psychiatric instabilities to packs of Champix, then again, maybe they should just pull the thing off the shelves?

Finally, a documentary aired on 'BBC Scotland Investigates' - "Ashes to Ashes". I'm unsure when it was aired.

It's in four parts [part four just over an hour in length] and well worth watching:










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Thursday, August 20, 2009

The Caspper Files [GSK's Ghostwriting Machine]




So, what exactly is CASPPER?

CASPPER stands for, Case Study Publications For Peer Review.

The fact that the name is synonymous with a ghost [Casper] is probably just down to high jinks from the Glaxo [SmithKline Beecham] team. It could also be high jinks that the name 'Paxil' could possibly be named after a toxic fungi [Paxillus involutus] although that is just supposition on my part.

Okay, let's dissect Caspper.

The Paxil Product Management launched Caspper, an apparent innovative program that was intended, it appears, to bring to the attention of 'important psychiatrists' by

**Offering assistance in the preparation and publication of case studies and other short communications relevant to the features and benefits of PAXIL.

** Encouraging the timely publication of responses to unbalanced information from competitors.

It appears the goal of Caspper was to benefit the salesforce by expanding the database of published data to support PAXIL. Furthermore, Caspper was also intended to strengthen relationships between the salesforce team [Reps] and 'key physicians and thought leaders in the psychiatric field.'

The objectives of Caspper were to 'strengthen the product positioning and overcome competitive issues.'

Some of the target areas for topic were:

**Anxiety disorders [eg; panic disorder, social anxiety disorder, and Obsessive Compulsive Disorder [OCD]

**Long term use of Paxil

**Use in the elderly

**SSRi use in women

** Successful management of sexual dysfunction


Quite ironic that they should target these particular topics. Long term use of Paxil has always been a grey area, in fact I don't even think GlaxoSmithKline have any answers to what damage prolonged use of Paxil can cause those taking it... if they do, then they are hiding it well.

Use in the elderly - hasn't there been studies that show vulnerability in children and the elderly taking Paxil?

SSRi use in women - Funny they should target this particular area. Here is a snippet from Dr. David Healy's withdrawal protocol JULY 2009 SSRI WITHDRAWAL GUIDE BY DAVID HEALY

"One of the biggest problems of SSRI dependence involves women who are on treatment and unable to stop who wish to become pregnant. Getting off an SSRI at present seems more difficult for women than men, even with the incentive of wishing to become pregnant."

Wasn't Healy the same man GSK targetted many years ago when he first spoke out against SSRi's?

I seem to recall Dr. Alastair Benbow, Head of European Psychiatry for Glaxosmithkline, claim that "Doctor Healy has made the same claims about a range of other medicines. He made the same claims about Prozac, he made the same claims about Prozac, he made the same claims about a range of other SSRIs. On every occasion he has been found to be wrong."

I think it is safe to assume now that Healy was right all along don't you Dr. Benbow?

Caspper continues to explain to the salesforce team that they should encourage physicians to author a paper regarding the benefits of Paxil. With the help of Caspper, it seems, writing a paper was never easier! In fact, Caspper seemed to do everything for the physician:

The full range of editorial assistance that CASPPER can offer contributing physicians is:

**Developing a topic

**Coordinating the editorial review process

**Submitting to the target journal

It even went as far as:

**Copy editing and proofreading

**Production of tables and graphics

** Preparation of the submission package

**Follow-up

It seems from this document that the aim was to more or less let Glaxo take control. [GHOSTWRITER]

The closing remarks of the 14 page document sums it all up.

"PAXIL Product Management has budgeted for 50 articles for 2000. Your participation in CASPPER will enable your physicians to add to the literature supporting the use of PAXIL, strengthen your relationships with key physicians and thought leaders in the psychiatric field, and ultimately, help you meet your sales goals."

The document is now hosted online.

Please disseminate.





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

Possible Caspper Articles

McHenry - Industry-Sponsored Ghostwriting in Clinical Trial Reporting- A Case Study

On the Origin of Great Ideas Science in the Age of Big Pharma



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WHO YOU GONNA CALL?




Fid

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Glaxo used ghostwriting program to promote Paxil

Hat-Tip - Ruth

Source: - Associated Press

Glaxo used ghostwriting program to promote Paxil
By MATTHEW PERRONE (AP)

WASHINGTON — Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.

An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.

Known as the CASPPER program, the paper explains how the company can help physicians with everything from "developing a topic," to "submitting the manuscript for publication."

The document was uncovered by the Baum Hedlund PC law firm of Los Angeles, which is representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects.

A spokeswoman for London-based Glaxo said the published articles noted any assistance to the main authors.

"The program was not heavily used and was discontinued a number of years ago," said Mary Anne Rhyne.

According to the memo, which dates from April 2000, the CASPPER program was designed to "strengthen the product positioning and overcome competitive issues."

At the time, Paxil was competing with rival antidepressant blockbusters like Eli Lilly's Prozac and Pfizer's Zoloft. Paxil has since lost its patent protection and competes against cheaper generic versions. Sales of Paxil last year totaled $849 million.

Drug companies frequently hire outside firms to draft a manuscript touting a company's drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work.

But the use of ghostwriting by drug companies has come under increased scrutiny by members of Congress, including Sen. Charles Grassley, R-Iowa, a longtime critic of the industry's influence over physicians. Grassley and Sen. Herb Kohl, D-Wis., are pushing a bill that would require companies to disclose all payments to physicians over $100.

According to ghostwriting expert Dr. Leemon McHenry, Glaxo's program was unusually intertwined with its internal sales and marketing department.

"We know that GSK has engaged in ghostwriting for many years," said McHenry, who works as a research consultant for Baum Hedlund. "But to create an internal ghostwriting program and have the gall to name it after a cartoon ghost demonstrates their juvenile attitude and careless disregard for patients."

McHenry acknowledged that ghostwriting is legal in principal, but said it could contribute to illegal activity if the information is misleading and causes harm.
"If these ghostwritten publications are contributing to the harm of patients because they're making false claims, then that's illegal," McHenry said.

Articles from the company's program appeared in five journals between 2000 and 2002, including the American Journal of Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry.

Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective.

Publication in a medical journal also is a point of prestige for physicians, a fact Glaxo's memo seems to acknowledge: "Physicians will be eager to participate in CASPPER regardless of their professional stature," the brief notes.


Copyright © 2009 The Associated Press. All rights reserved.

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Wednesday, August 19, 2009

Ghostwriting in drug research back in the spotlight

Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial author, Alison Bass has a great post on her blog entitled, "Ghostwriting in drug research back in the spotlight."

Alison highlights New York Times journalist, Natasha Singer, who focuses on Wyeth's use of a ghostwriting firm to prepare an estimated 60 articles favorable to its hormone drugs.

Alison writes:

"Wyeth's use of ghostwriters to prepare favorable studies and then find doctors willing to put their names on them is, of course, only the latest in a long string of drug industry campaigns to present new products in the most positive light possible. The makers of the SSRI antidepressants were masters at this tactic. As I reveal in Side Effects, GlaxoSmithKline hired a ghostwriting firm, Scientific Therapeutics, to write the first draft of the controversial Paxil study 329. That draft concluded that Paxil was effective and well tolerated in adolescents, even though the actual data in the clinical trial showed otherwise. See back story here. Indeed, in its re-examination of clinical trial data for all the antidepressants, the FDA labeled study 329 a negative study, finding that Paxil was no more effective than placebo in treating depression in adolescents. Yet Martin Keller, the principal investigator of the Paxil study, and his co-authors, did not object to the ghostwritten version of the study and despite its inaccuracies (which were flagged by peer reviewers), the study was published in The Journal of the American Academy of Child and Adolescent Psychiatry in 2001 and used by GlaxoSmithKline to heavily flog the drug for use in children and adolescents."


Full article can be read HERE


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The Department of Healh on CYP2D6 Deficiency

DE00000433477

Dear Mr Fiddaman,

Thank you for your email dated 24 July to the Department of Health expressing your view that patients should be tested for deficiency in CYP 2D6 before being treated with Selective Serotonin Reuptake Inhibitors (SSRIs). I have been asked to reply.

I understand that you have had correspondence with the Medicines and Healthcare products Regulatory Agency (MHRA) on this issue, and that you are aware of the conclusions of the Committee on Safety of Medicines' Expert Working Group on the Safety of SSRIs that a number of different factors, including genetic variation, could potentially impact the effectiveness and safety of SSRIs for individual patients.

Before a test for CYP 2D6 deficiency could be recommended for routine clinical use, there would need to be evidence from specific clinical trials which demonstrated the value of such a test in predicting which patients would suffer adverse reactions. Research of this nature has been very limited and we currently do not have good evidence to suggest that people who are CYP 2D6 deficient are at higher risk of adverse reactions to SSRIs. A recently published article on this subject - Pharmacogenetics of Selective Serotonin Reuptake Inhibitors and Associated Adverse Drug Reactions (Pharmacotherapy 2009;29(7):822-831) - has reviewed the available evidence for a genetic basis of adverse reactions to SSRIs. The review highlights the large number of genetic variations which could affect the response of the individual to SSRIs, and the authors conclude that ‘no clear associations have been established between CYP 2D6 and the risk of adverse reactions’.

It is important that patients are monitored for adverse effects of SSRIs, whatever the underlying reason is for them experiencing the adverse effects. There are warnings present in the product information in line with this. Where there is evidence that the effect of paroxetine on CYP 2D6 has clinically relevant impact on patient safety - in the area of interactions between paroxetine and other drugs - there are detailed warnings in the product information.

The impact of genetic variation is important for the effectiveness and safety of many drugs, but the science of pharmacogenetics still has limited application in clinical practice. The MHRA is working with other European regulatory authorities and the European Medicines Agency to identify where there are screening mechanisms available to identify patients who will gain the greatest benefit from a particular medicine, or who may have an increased risk of adverse reactions.

You may be interested to know that the Department recently awarded Liverpool University and Professor Munir Pirmohamed the first NHS Chair in Pharmacogenetics. Professor Pirmohamed leads a team of clinicians, scientists and nurses in identifying genetic variations that dictate a patient’s positive or negative response to a drug.

The Chair will complement a £10million Centre for Personalised Medicines created at Liverpool University . In addition to contributing to research on pharmacogenetics, the remit of the NHS Pharmacogenetics Chair includes helping to establish a UK Pharmacogenetics Forum.

The Department had previously targeted funding for pharmacogenetics, and funded six research projects at a cost of around £4million. The focus of the research is on existing medicines, the pharmacogenetics of which are unlikely to be addressed without public sector funding. This included research on certain generic medicines used in the NHS, such as warfarin, an anti-clotting drug used to treat thrombotic disorders, and drugs involved in epilepsy and hypothermia or drugs that have been implicated in toxicity.

I hope this is helpful.

Yours sincerely,

Martin Gatty
Customer Service Centre
Department of Health

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Tuesday, August 18, 2009

Stalkers Request Information from MHRA

The following are requests under the Freedom of Information and other correspondence made to the MHRA by a couple [could be more] of stalkers who seem to take great delight in wasting the MHRA's time and seem to have a very unhealthy interest in me.

The following are all jpg files. For clarity, all images will be opened FULL screen when clicked on.

More about stalkers and their disdain toward Seroxat campaigners, lawyers and litigants can be found at 'In The Pocket of GlaxoSmithKline' blog [Now removed]

Request for Minutes of MHRA meeting I had on Sept 2nd 2008.
The request was made on the day of the meeting. Also, on the same page, a Freedom of Information request for minutes to the meeting I had with MHRA Communications Director, Simon Gregor on the 15th May 2009. This request was made 3 days after I met with Simon and also appears on the 'Tuesday 1st Correspondence with the MHRA' blog. For those that don't know, 'Tuesday1st' is a name used by Mardi Bennett of the Blackheath area of Colchester, UK. Her blog seems to be a fixation on what I am talking about to the MHRA with various meetings. In fact, I find her blog to be bordering on the obsessive. [Stalker material, but that is just my opinion] You would have to check it out for yourself to draw your own conclusions. [HERE]



Email from MHRA Communications Director, Simon Gregor to person/s whom had wrote him suggesting names that I had put forward for Simon to meet with were in some way connected to Scientologists.



And here is the suggestion that names I put forward for Simon Gregor to meet with were connected with Scientologists.



On the following jpgs, Simon Gregor ia asked a series of questions relating to Dr. David Healy and whether or not the MHRA 'endorse' Dr. Healy's new protocol for SSRi withdrawal [June 09 SSRi withdrawal Protocol]




The following is a strange request. When I met with Simon on the 15th May 2009, I gave him some names of people I thought he should speak to with regard to the patient and public strategy initiative by the MHRA. This person, Mardi Bennett, from the Blackheath area of Colchester, UK has already gone on public record and showed an un-redacted version on her blog

At the top of this jpg Simon Gregor explains how I put her name forward after she had previously sent him an email [included in jpg] asking: "Please can you confirm if Mr Fiddaman proffered details of mine to enable you to contact me and if so, please can you tell me exactly what details he disclosed?"

I merely put her name forward to Simon as someone he may find useful to talk to. Despite this, it seems, Mardi wanted to believe otherwise:



Mardi had previously enquired about my article on the meeting with yet another email to Simon Gregor a day previous: - Once again, an un-redacted version appears on her blog



Here Simon gets a thank you reply with the message: "...being new to the area of the prescription drugs boards you were not to know the history of actions the Seroxat campaigners have do use to protect their fragile litigation - to the detriment opf raising awareness about problems with other drugs in the class."

It is very strange that someone would think this despite evidence to the contrary



JPGS 14 & 15 are extensions of the correspondence [above]





Here the MHRA are sent a 'Blog Review Report' The report highlights another blog authored by Mardi Bennett - http://tuesday1st.blogspot.com

The report also highlights Matt Holford's blog, 'It's Quite An Experience'



Page two of the email regarding the 'blog report' highlights the 'Anti-Fiddaman Blog'

It appears the MHRA have an opinion of who is behind the blog as they have redacted the name for data protection purposes. The email shows blog links that are similar to my blog - whereas my blog is fiddaman.blogspot, this particular blog, the 'Anti-Fiddaman' one, uses bobfiddaman.blogspot.





The last two jpgs refer to a recent post of mine regarding the revised version of David Healy's withdrawal plan. It is a Freedom of Information request. The same request appears on the UK Survivors forum - it was signed and posted by Jeremy Bryce.





I am baffled as to why these two individuals seem to want to put me on a pedastal, further more it astounds me that they have so much time on their hands, time that would be better spent highlighting the dangers of SSRi's.

There are more lucid claims by this duo at 'In The Pocket of GlaxoSmithKline Blog' - be sure to scroll down to see Jeremy Bryce's obvious obsession with me.


It would appear that former Strangford resident Jeremy Bryce and resident of Blackheath, Colchester, Mardi Bennett, are hell-bent on trying to discredit me.

Jeremy Bryce currently denies being behind the 'bobfiddaman.blogspot' blog.

I'm still scratching my head at Mardi Bennett's interest in the current Seroxat litigation - I stopped scratching my head regarding Jeremy sometime ago after a member of his immediate family wrote me suggesting that 'Jeremy was okay whilst on his medication'

I'll never figure out what motivates certain people to do what they do? A sick desire, jealousy, narcissism? Who knows?

Jeremy Bryce now has a fake 'Bob Fiddaman' Twitter account HERE


Fid

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IMB advises against 'Seroxat' in pregnancy

Source: The Irish Times

Tuesday, August 18, 2009

THE IRISH Medicines Board (IMB) has advised women who want to become pregnant and are taking the antidepressant Seroxat to discuss the risks and benefits of continued treatment beforehand with their doctor.

It has also advised that pregnant women who are taking the antidepressant should not stop their treatment without seeking advice from their doctors.

Some studies have found an increased risk of birth defects, particularly heart defects, associated with the use of Seroxat during the first three months of pregnancy. These findings are not new, but last week Irish psychiatrist Prof David Healy, who is based in Wales, said he believed many GPs still prescribed Seroxat to women without adequately informing them of the risks.

He pointed to studies showing that the rate of birth defects and miscarriage doubled if a woman was taking Seroxat.

“Ten to 15 years ago, most doctors would have been quite cautious about the idea of putting any woman who was pregnant or thinking about becoming pregnant on one of these drugs but the culture has changed,” he said.

The IMB said it had highlighted the link between birth defects and Seroxat to healthcare professionals in a newsletter three years ago.

It also approved a letter from Seroxat manufacturer GlaxoSmithKline, which was sent to all healthcare professionals in the same year. That letter highlighted that paroxetine (Seroxat) should be used in pregnancy only when strictly indicated and said doctors should prescribe Seroxat to pregnant women only if the potential benefits outweigh the potential risks.

Thousands of Irish women are prescribed antidepressants but it is not known how many pregnant women are taking Seroxat.

Dr Mark Walsh, chairman of the Irish College of General Practitioners (ICGP), said he did not believe the prescribing of Seroxat to pregnant women was widespread in Ireland. “The ideal thing is not to prescribe anything at all during pregnancy,” he said.

However, people did become depressed and GPs had to make a clinical decision based on each individual case. The potential risks of any medication should always be discussed with the patient, he said. He said Seroxat was a good drug in certain cases but other antidepressants had a lower risk factor if a pregnancy was involved and GPs were aware of the potential risks.

The prescribing of the antidepressant to women who might become pregnant could also be problematic as some women find themselves unable to stop taking the drug when they become pregnant.

FULL STORY

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Sites of interest that relate:

The Truthman's excellent - Seroxat Kills Babies


Monday, August 17, 2009

GlaxoSmithKline Pregnancy Registries

Stumbled upon this website from GlaxoSmithKline. It's information 'intended only for healthcare providers.'

A paragraph that really caught my eye was the following:

"The safety of the products (listed below) during pregnancy has not been established, and no adequate human studies have been performed. None of these products, except RETROVIR® (zidovudine, AZT) after the first trimester, is approved for use during pregnancy. Except for RETROVIR®, these products should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus."

Did I read correctly?

'...these products should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus'

Maybe GlaxoSmithKline should add Paxil [Seroxat] to the pregnancy registry or maybe they already have the data for the risks of taking Paxil during pregnancy but have decided not to 'come across it' yet?

There's a LYMErix® Pregnancy Registry on the website. To learn more about GSK and LYMErix® read this fascinating article from 2001

Remember folks, GlaxoSmithKline is a leading healthcare company that helps people to do more, feel better and live longer.

Go check out the GlaxoSmithKline Pregnancy Registries

Fid

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Sites of interest that relate:

The Truthman's excellent - Seroxat Kills Babies


JULY 2009 SSRI WITHDRAWAL GUIDE BY DAVID HEALY


Sunday, August 16, 2009

SSRi's and non-SSRi's into Liquid

The likes of GlaxoSmithKline will tell you the liquid formulation is for people who have difficulty in 'swallowing' the tablets.

Many SSRi's are not available in liquid form, making it harder for the patient to taper.

If your doctor suggests cutting your tablet in half or skipping a dose, show him the following [FIG 1]

Your medicine CAN be changed into a liquid to help you taper more easily. Pharma want you hooked - the liquid will help ease the addiction - because addiction is what it is.

Print off the following for your doctor.

Fid




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David Healy Withdrawal Protocol **Updated

On June 28, 2009, I announced on this blog that David Healy had put forward a withdrawal protocol to the MHRA with regard to SSRi and non-SSRi withdrawal. After much correspondence between David and patient advocates he has now revised this protocol.

Because of obsessive individuals who chose to slander myself, Healy and other advocates, the new protocol is available via my email address ONLY.

Those of you who want a copy, please contact me by scrolling down my blog until you find the animated letterbox [right hand sidebar] or click on the following link -
JULY 2009 SSRI WITHDRAWAL GUIDE BY DAVID HEALY

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Saturday, August 15, 2009

Diseased African Monkeys Used to Make Swine Flu Vaccines!

Conspiracy?

You decide.

Diseased African Monkeys Used to Make Swine Flu Vaccines; Private Military Contractor Holds Key Patents.

To most people, vaccines sound medically harmless. “They’re good for you!” say the doctors and drug companies, but they never really talk about what’s in those vaccines. There’s a good reason for that: If people knew what was really in those vaccines, they would never allow themselves to be injected with them.

Aside from the dangerous ingredients many people already know about (like squalene or thimerosal), one of the key ingredients used in flu vaccines (including the vaccines being prepared for the swine flu pandemic) is the diseased flesh of African Green Monkeys. This is revealed in U.S. patent No. 5911998 - Method of producing a virus vaccine from an African green monkey kidney cell line. (http://www.patentstorm.us/patents/5911998/claims.html)

As this patent readily explains, ingredients used in the vaccine are derived from the kidneys of African Green Monkeys who are first infected with the virus, then allowed to fester the disease, and then are killed so that their diseased organs can be used make vaccine ingredients. This is done in a cruel, inhumane “flesh factory” environment where the monkeys are subjected to a process that includes “incubating said inoculated cell line to permit proliferation of said virus.” Then: “harvesting the virus resulting from step (c); and… (ii) preparing a vaccine from the harvested virus.”

FULL STORY

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Thursday, August 13, 2009

SEROXAT IN THE MEDIA

GlaxoSmithKline's Seroxat seems to have had a lot of coverage in the mainstream media over the past couple of weeks. All for the wrong reasons it seems.

Any time the words 'antidepressant ' or 'SSRi' are used, Seroxat seems to be in the forefront of any particular news story, in the UK at least.

I cannot think of any other product that has received so much bad press that still remains on the market. The manufacturers, GlaxoSmithKline, continue to robustly defend it whilst the UK medicine regulator [MHRA] remain tight-lipped about the current news events.

Personally, I cannot see why Seroxat still remains on the market. With reports and academic papers suggesting that it causes a vast array of severe problems, I am astounded as to why it has not been either recalled or banned.

Seroxat is one of many SSRi's, prescription figures would have declined due, in the main, to four [count them] programmes on BBC TV's Panorama that have highlighted the dangers of this particular SSRi.

What would the consequences be if Seroxat was pulled from the market?

It's pretty obvious really, well to me at least. If Seroxat was pulled from the market it would raise concerns about other SSRi's, concerns that are only raised by campaigners and get very little coverage in the mainstream media. Seroxat seems to be the daddy of all SSRi's, the Coca Cola of the soft drinks world. Remove it from the market and the mainstream media would probably focus on the next SSRi.

I can see no benefit of Seroxat, none whatsoever. The longer it remains on the market will mean countless suffering for people on other SSRi's. Once removed, it will open the doors for other SSRi's to be thoroughly investigated and maybe other bloggers, campaigners, advocates can start banging the drum and asking the regulator about Prozac, Zoloft and other SSRi related drugs.

In Seroxat we have one drug of a whole class. To play down it's side-effects is playing down the side-effects of every other SSRi. Seroxat is a celebrity, it's one that the media have got their fingers into. Once this celebrity is dead and gone they will move on to something else. Then, and only then, will other SSRi's get the press coverage other advocates seem to be calling for.

As far as I'm aware Seroxat is the only SSRi in the UK that is currently going through the High Court with regard to it being a defective product. With the recent press reports, it would appear that it is defective. GSK lawyers can argue that it is only as defective as other SSRi's on the market - not much of an argument but one that they will no doubt use. Probably another reason why the MHRA won't intervene and say 'enough is enough.' To pull Seroxat would have a devastating effect on the outcome of any lawsuit.

I never used to be in the camp of banning Seroxat but if one looks at the bigger picture you will see that it is the only way forward. There is no benefit of Seroxat... and even if it could be argued that there was then the risks would far outweigh any benefit. When a drug is licensed by the MHRA the main focus on whether it is safe and effective is the risk/benefit ratio. Somewhere along the line we have been lied to - either that or we have a bunch of very incompetent people regulating the drugs you, I and our children take.

Ban Seroxat... then start looking closely at the other SSRi's. Glaxo are not the only pharmaceutical company who have been less than forthright with the truth.

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12/08/2009 Depression pills 'double suicide risk in young adults'

08/08/2009 Doped and duped

08/08/2009 GPs still handing out antidepressants linked to birth defects

07/08/2009 Women given antidepressant that can cause birth defects

More HERE


Fid

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Wednesday, August 12, 2009

Safety information on oseltamivir (Tamiflu) and zanamivir (Relenza) for pandemic swine influenza A/H1N1

Latest Safety Information from the MHRA

Tamiflu and Relenza are both neuraminidase enzyme inhibitors. They act by inhibiting entry of influenza virus into uninfected cells and preventing the release of recently formed virus particles from infected cells. Tamiflu is given orally (capsules and solution) and Relenza is given by inhalation (Diskhaler system).

Both have substantial experience of use and favourable benefit-risk profiles.

Tamiflu Side effect profile

The most common side effects of Tamiflu are nausea, vomiting, diarrhoea, abdominal pain, and headache. These may usually occur after the first dose and will usually stop as treatment continues. The frequency of these effects is reduced if Tamiflu is taken with food. More-serious side effects are very rare (see Summary of Product Characteristics for further information).

The product information for Tamiflu lists neuropsychiatric disorders (reports of convulsions and delirium) in the side-effects section. These events were added to the product information as a precautionary measure—a causal association between Tamiflu and the reported events is uncertain.

Drug interactions

Clinically important drug interactions with Tamiflu are unlikely, including those involving competition for renal tubular secretion. However, care should be taken when prescribing Tamiflu for patients who are taking co-excreted medicines with a narrow therapeutic margin (eg, chlorpropamide or methotrexate).

No dose adjustment is required when coadministering with probenecid in patients with normal renal function. Coadministration of probenecid, a potent inhibitor of the anionic pathway of renal tubular secretion, results in an approximate two-fold increase in exposure to the active metabolite of oseltamivir.

Renal impairment

Dose adjustment is recommended for adults with severe renal insufficiency (ie, ≤30 mL/min). Tamiflu is not recommended for patients with a creatinine clearance of ≤10 mL/min or in those undergoing dialysis.

Full Update

Press reports and comment regarding Tamiflu and Relenza:

Swine flu: more than 400 cases of Tamiflu side effects

Flu drug 'nearly killed daughter of TV presenter'

Leading article: This abuse of Tamiflu is dangerous for all of us

Government virus expert paid £116k by swine flu vaccine manufacturers GlaxoSmithKline

GlaxoSmithSwine



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Fid

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SSRi Antidepressant Drugs - Jeffrey Dach

A must read for patients, doctors and regulators.


SSRi Antidepressant Drugs
Jeffrey Dach




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Fid

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Depression pills 'double suicide risk in young adults

Source: Mail Online

*Snip:

Latest figures show in the UK in 2007 there were 34 million prescriptions for antidepressants, of which 18 million were for SSRIs.

Between 1993 and 2002, there were 4,767 deaths in England and Wales involving antidepressant drugs, according to the Office of National Statistics.

A spokesman for the Medicines and Heathcare Products Regulatory Agency said the UK's Yellow Card system recorded side effects and adverse reactions associated with medicines.

She said: 'We monitor the Yellow Card reports so we can look for any trends in this area.'

FULL STORY

4,767 'KNOWN' deaths.

The Yellow Card system barely scratches the surface. The time has come for the thousands of anecdotal reports available on the Internet to be taken into consideration.

If the MHRA wish to call themselves regulators then they should regulate ALL the available evidence and not rely on a system that is flawed.

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Fid

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Tuesday, August 11, 2009

Woman Charged With Smothering Grandson Was On Paxil!

Source: WCCO

"According to the Dakota County Attorney, Miller-Steiner told police she was on some prescription drugs, Paxil and an antidepressant, and she had two martinis over two hours. She laid down in bed with the child as she fed him and she fell asleep."


Aug 11, 2009

A grandmother has been charged with manslaughter after she fell asleep in bed with her infant grandson and rolled onto him, suffocating him.

Tina Louise Miller-Steiner, 45, of Lakeville was charged on Tuesday with two counts of second-degree manslaughter. The incident happened in May while Miller-Steiner was babysitting 6-month-old Evan Michael Berney.

According to the Dakota County Attorney, Miller-Steiner told police she was on some prescription drugs, Paxil and an antidepressant, and she had two martinis over two hours. She laid down in bed with the child as she fed him and she fell asleep.

One of her daughters came home and found Miller-Steiner on the child, and Evan was pale. Miller-Steiner told her daughter to call 911 while she performed CPR, but Evan was pronounced dead at the hospital.

"This was a tragic death which could have been avoided. Our sympathy is extended to parents and family of Evan Berney," said Dakota County Attorney James Backstrom.

In June, Miller-Steiner told WCCO's Bridgette Bornstein that she is heartbroken as she struggles with the death of a grandson she adored.

"I think about my grandson all the time. I think about how tragic the accident was," she said.

Tears streamed down Miller-Steiner's face as she described what happened the night she was babysitting her grandson.

"He was everything to me. I was totally in love with him. I was there when he was born. I got to help bring him into the world," she said. "Everybody who knows me knows how much I loved that baby. I would have never intentionally hurt him."

At the time, Miller-Steiner said she created a garden as a tribute to her grandson. She was in counseling, had trouble sleeping but she was trying to be strong for her daughters who were also having a terrible time dealing with the child's death.

"It is an accident no matter what the circumstances are and I will live with this for the rest of my life," she said.

Because of what happened to Evan, Miller-Steiner wanted to send out a warning not to share beds. She didn't think it was dangerous but now she realizes it can be.

Miller-Steiner made her first court appearance on Tuesday. Her bail was set at $200,000 and her next court appearance scheduled for Aug. 25.

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Fid

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