HAPPY NEW YEAR

HAPPY NEW YEAR.

MAY 2010 BRING YOU ALL PEACE AND HAPPINESS.


Fid


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The Evidence, However, Is Clear...The Seroxat Scandal

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More Advertising Woes for GlaxoSmithKline

Image: aboutus.org


If the latest news regarding GlaxoSmithKline's false claims with advertisements wasn't enough to shake your head in disbelief then this latest should leave you scratching the scalp on your bonce!

James Williams, who writes for the Atlanta Wellness Examiner, has recently told of his journey into the world of GSK marketing where he stumbled upon a GSK advertisement on a children's gaming site!

Williams writes:

"My friends' son, who is eight, was playing an online game yesterday. It was a harmless activity where he had to breakup icebergs to save the crew members on a stranded ship.

While he was waiting for the game to load, I noticed that an advert appeared in the gaming window. It was on the screen for precisely 10 seconds before the game started.

The wording on the advert read: This time, talk to your doctor about VESIcare. This medication, produced by GlaxoSmithKline, relates to blocking the symptoms of urinary leakage."

I've viewed the website in question, nitrome.com, and it is most definitely aimed at young children, its background being a mish-mash of cartoon images set against a Christmas type scene, normally reserved for kids advent calendars.

Last year I reported that Lola's Land, a UK children's website, were promoting Glaxo's Cervarix. Strangely, Lola's Land has now been removed as has the promotion for GSK's Cervarix. Slogans that ran on Lola's Land included; “Remember chica, this is a totally life-saving, revolutionary vaccine!” and “Let’s fight cervical cancer together and arm ourselves against it!”

It does seem rather odd that this website has now been removed, don't you think?

Lola's Land was registered to Freida A Tallon, the contact address for Freida being none other than British Sky Broadcasting Ltd. Now why would a TV Company promote a pharmaceutical product?

Here is how Lola's Land promoted Glaxo's "totally life-saving, revolutionary vaccine!"


CLICK ON IMAGE TO SEE GOOGLE CACHE OF PAGE

So, it would appear that GlaxoSmithKline struck a deal up with the UK government and British Sky Broadcasting, a deal that, at the time, told the young readers of Lola's Land, how dangerous Cervical cancer was and how they need not worry as a "totally life-saving, revolutionary vaccine!" was just around the corner to help them.

With this in mind, I have wrote to the registrant of Lola's Land, an address that has a bskyb domain.

Dear Freida,

Researching GlaxoSmithKline's Cervarix vaccine I stumbled upon your name as the registrant of Lola's Land - I had previously wrote about Lola's Land on my blog here - http://fiddaman.blogspot.com/2008/09/lolas-land-promoting-hpv-vaccine.html

I notice that Lola's Land has now been taken down. Could you tell me why please?

Could you also tell me why British Sky Broadcasting were behind such an advertising venture?

Many thanks

Bob Fiddaman
---

Author of Seroxat Sufferers
http://fiddaman.blogspot.com


I will of course let you all know should I receive a response from Freida Tallon.


Fid

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Glaxo asked to remove advertisement!

The Indian drug regulator, the Drug Controller General of India [DCGI] has asked GlaxoSmithKline to withdraw its promotional advertisement for Cervarix with immediate effect.

The ad claims that Cervarix can prevent cervical cancer but the DCGI blame the advertisement for oversimplifying the complexity of cervical cancer thus misleading the consumers. According to them it does not provide relevant information for helping consumers to make an informed decision, including the fact that it violates Rule 106 and Schedule J of the Drugs and Cosmetics Act, 1940 under which no cancer prevention claim can be made.[1]

The Act states that "no drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure one or more of the diseases or ailments..."

The Act also states that before launching any campaign, prior permission of the government is needed.

However, GSK has not taken any such permission.

More can be read HERE


[1] Rumpus About Cancer Vaccine Advertisement

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PAXIL [SEROXAT] MARKETING

What GlaxoSmithKline tell you...

PAXIL TV AD 2000




What GlaxoSmithKline's consumers tell you...

TAPERING OFF PAXIL




What GlaxoSmithKline tell you...

PAXIL TV AD 2002




What GlaxoSmithKline's consumers tell you...

TAPERING OFF PAXIL METHOD




What GlaxoSmithKline tell you...

PAXIL CR AD 2003





What GlaxoSmithKline's consumers and the media tell you...

PAXIL ADDICTION STORY




SEE: 15 QUESTIONS TO ASK YOUR DOCTOR


Fid

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TOPSY TURVY CHRISTMAS

It's Christmas time again

The snow is falling down.

Its flakes are made of sugar

And are coloured chocolate brown.

There's snowmen without hats on

Dogs with ten foot tails

And Santa's sleigh with bells on

Is pulled by killer whales.

Christmas trees lean sideways

And monkey's live within.

They swing from branch to branch

And they make an awful din.

Holly is not prickly,

Bells don't make a sound.

Baubles on the Christmas trees

Are triangular, not round.

There's turkey's playing football

Against the three wise men.

They play with rolled-up stuffing

And the referee's a hen.

Cats sing Christmas carols,

Toys all come alive.

Action men have dresses

While Barbie scuba-dives.

There's gravy over puddings

And peas are filled with cream.

In my topsy-turvy Christmas,

My topsy-turvy dream.

© BOB FIDDAMAN

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MERRY CHRISTMAS TO ALL MY READERS

May you get everything you wish for.

Thanks for stopping by this past year.

Keep warm, stay safe and don't drink too much.

Fid

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Miserable Christmas For Wonderful Advocate

I was alerted to a recent post by Phil Dawdy over at Furious Seasons this morning. He writes about Steph, who writes the hugely popular Soulful Selpulcher blog.

For the last three years Steph has been battling against the Washington State Mental Health System.

Personally, I find the ruling absurd. Steph's daughter, Lindsey, was found NOT to be a danger to her self or others. Perversely, she was found to be at danger from society as she often wanders off.

It would appear that the Washington State Mental Health System have failed Lindsey here. Nobody knows their own child like their mother. Linds, as Steph likes to call her, has been diagnosed with apparent schizophrenia - Steph believes her daughter has autism.

Phil Dawdy goes into more detail and briefly touches on the history of Western State Hospital, the place where Linds has been ordered to.

As for Steph, she will visit her daughter tomorrow, knowing that she will have to leave at some point because of some perverse ruling by an even more perverse mental health system.

My heart goes out to Steph. She has supported the work of many bloggers over the years I have known her. She always has time to read about other advocay work, despite her own struggles.

Steph, this blog salutes you and hopes the Washington State Mental Health System will see sense and allow a loving mother to look after her child, I also hope the ruling made by the King County Superior Court can be overturned and common sense can prevail.

I urge those of you reading this to head on over to Steph's blog to offer your support. She's a true gem with a heart of gold.


Fid

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Balancing act: Moms-to-be weigh risks, benefits of antidepressants

Image: www.ecobiz.ie

Source: WCFCOURIER.COM

Good friend of mine and fellow advocate Julie Edgington has recently been interviewed by the WCF Courier.

They write:

In 2003, Julie Edgington was among the roughly 13 percent of expectant U.S. women to take an antidepressant during pregnancy. The Waterloo woman started a Paxil regimen a few weeks before she became pregnant with her son, Manie.

"I really didn't feel right about taking it because with all my other children I never took anything - I was even careful with Tylenol," said the mother of five. "I was completely off it by the end of the third month of my pregnancy, but by that time it was too late."

Manie was born with his aorta and pulmonary arteries switched. At just 8 days old he underwent open-heart surgery. Manie will have to repeat the procedure when he is 17 and requires continued care. Edgington and her husband, Russell McNamee, along with several other families across the country, have a lawsuit pending against GlaxoSmithKline, which manufactures Paxil.

Today, Edgington blogs about her experiences. Although Manie's case is rare, she warns other moms that - in her opinion - antidepressant use during pregnancy is too big of a risk.

"What benefits could be great enough to put your child through a lifelong battle with their health?" she asked. "I'm not a doctor, but I would definitely tell someone to try some other type of therapy before taking anything. It's not worth it."


Julie's blog, Birth Defects Caused by Antidepressant, can be viewed HERE

Her son, Manie, is a little diamond and a constant reminder of how difficult it is for expectant mothers to weigh up the benefits v risks when trying to make an informed decision of whether to take Paxil [Seroxat] A decision that cannot be easily made without knowing the full facts - facts kept from doctor's and patients with regard to Paxil [Seroxat] being a teratogen.

Manie Rocks!

Fid

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Christmas comes early for 3,700 US doctors on GlaxoSmithKline's payroll

Image: versacreations.net

Interesting post from the author of Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial, Alison Bass, on her blog.

Alison writes:

"GlaxoSmithKline became the third pharmaceutical giant to start disclosing all the speaking and consulting payments it makes to US doctors, and its list is an eye-popping illustration of the rampant corruption that runs through our current system of medical research."

She adds:

"Surprise, surprise, one of the drugs given an enthusiastic thumb's up in this review is Xyzal, an antihistamine made by GlaxoSmithKline."

You can read more HERE

Also, you may want to check out her book. If you get a book token as a Christmas present Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial comes highly recommended.

Fid

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15 Questions To Ask Your Doctor

Image: maaadddog.files.wordpress.com



Myself and Janice Simmons, co-ordinator of the Seroxat User Group, have compiled a list of questions for UK readers of this blog to print off and to ask their doctors.

Personally, I believe we will never get help from the UK Medicines regulator [MHRA] nor the UK government regarding the safety of Seroxat and other SSRi's.

I also believe that it is the patient who has to educate the doctor because too many of them have been indoctrinated by ghost-written papers in medical journals and the hard sell of pharmaceutical reps.

This questionnaire, depending on the answers given to you by your doctor, should highlight the failings of the MHRA. Their 'don't give a damn' attitude is staggering as is their ignorance at accepting that there is a major problem with this particular class of drugs.

While pharmaceutical companies like GlaxoSmithKline continue to make out of court settlements to people who have complained that Seroxat has caused heart defects, suicide and withdrawal problems, the MHRA will bury their heads in the sand. The undeniable proof that is kept hidden from the public in sealed files suits both pharma and the MHRA. If there is no admittance then there is no problem.

Doctors need to be made aware of the truth - the MHRA have been made aware but continue to hold hands with their paymasters.

The safety of patients should be paramount and not the protection of pharmaceutical products and their reputations.

'15 Questions To Ask Your Doctor' are questions we should all be asking. There should be no problem asking these questions - even GlaxoSmithKline told me to ask my doctor if Seroxat was a teratogen - they refused to answer it themselves. The MHRA, as is the norm, sat on the fence with a limp-wristed and cowardly answer.

The MHRA are well aware that patients are struggling with Seroxat and other SSRi's. Listening to patient stories is simply not good enough. They have to act and the only way to get them to act is to highlight their failings.

There is a printible PDF for you to download. Ask your doctor, don't be afraid to ask questions regarding these drugs - any patient information leaflet will direct you to 'ask your doctor' if you have a problem with the drugs. Way I see it is their is a problem with doctor's not knowing the full facts because the UK medicines regulator are stuck in an outdated system of regulatory madness that protects the product and its manufacturer and NOT the patient.

For ease you can cut and paste the questions into your own word document.

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**EXCLUSIVE VIDEO: LAWYERS DISCUSS THE RECENT GLAXO V KILKER CASE

This is pretty riveting stuff - I only wish they could do this on national TV with an audience and I do hope that one day GlaxoSmithKline actually go the distance with an appeal and lose... instead of settling the case.

There are an awful amount of Internal documents from the Kilker case that have been sealed, they will remain sealed if Glaxo settle the appeal - which, they probably will.

Personally, I think this is appalling behaviour by GlaxoSmithKline. Lyam Kilker was born with heart defects [3 different heart defects as it happens] - A jury found GlaxoSmithKline's Paxil [Seroxat] to be the causation of his heart defects. Glaxo appeal the decision - yet settle other 'birth defect cases'. Meantime, the family of Lyam Kilker are plunged into another long wait which, I think, will result in an out of court settlement some time down the line.

It's one thing to manufacture a drug that harms a child, but to then punish the family and child because they won at trial is pretty despicable even by GlaxoSmithKline's standards.

Everyone, even GSK, have a right to appeal but we all know what the outcome of this tragic case is going to be - Glaxo will settle, they cannot afford for the sealed documents to be made public property.

My heart goes out to Lyam Kilker and his loving family. All his mother is guilty of is taken Paxil for what can only be deemed as mild depression. She never knew the damage it could cause her fetus because GlaxoSmithKline never told her... more importantly, they never told her doctor.

The case of Lyam Kilker was a 'test' case - basically Glaxo dipping their toes in the water to see how hot it is. It appears their toes were scolded.

Expect settlements with the other 630 birth defect cases they dispute.

Did they know of the dangers of pregnant women taking Paxil?

Watch the video.

The first 30 seconds is audio only, while the team prepare to go on air. The video is uncut and exclusive to Seroxat Sufferers blog.




Special thanks to the production team at Law Journal TV for passing this on to me and granting me permission to use on Seroxat Sufferers.

After watching the video, take a look at the files that have been made public from the recent Kilker v GSK trial, including a testimony from Ex-GSK executive Jane Nieman which was pretty damning for GlaxoSmithKline.

**Footnote

The MHRA have access to the documents. They refuse to act on them. A strong message of support for GlaxoSmithKline it would appear.

Fid

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Im Memory of Stuart Adamson

Image: multinet.no


For the late William Stuart Adamson. You'll always be where the heart is. Cheers Big Man

8 years gone but still very much in the hearts of the adoring fans of Big Country.



BIG MAN

Such pleasure you gave me with your prose
Now you have been flung just akin to the rose.
The hills seem so distant, the clouds have departed
Into the valleys of the broken hearted.


With your back against the wall all you saw was pain
Not even the Big Man could find strength to abstain.
The perils of booze was clear, the despair became threefold
Now all that’s left is memoirs of a chronicle left untold.


It must have been so lonesome, you must have felt so sad,
Trying to evaluate the good from the bad.
The choice was not yours, which I can recognize
So short your years devoid of compromise.


The angels are singing, home came their own
Upon the hills with your name cast in stone.
Thanks for all you gave me in that all you knew
But most of all Big Man thanks for being you



© BOB FIDDAMAN



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Paxil CR

Image: blogs.nashvillescene.com

Interesting find this morning.

A web page, http://paxilcr.info/ seems to have surfaced out of nowhere.

One would think it was an advertising page for GSK's Paxil [Known as Seroxat in the UK] but on closer inspection it would appear that this website has nothing good to say about Paxil.

If the recent posts are anything to go by then it would appear that the creator/s [possibly lawyers] of this website are trying to get a simple message out.

DON'T TAKE PAXIL

"Recent Posts"

Relationship Between Birth Defects, Strokes and Paxil
Dealing With a Paxil Birth Defect/Who Should Not Take Paxil
Paxil Not Safe for Children & Teens
Paxil Birth Defects
Paxil Recall Lawyer Discusses Paxil Addiction
Paxil (paroxetine)
Paxil May Increase Risk of Birth Defects
Paxil Birth Defects
Paxil Side Effects : the Ugly Side of Paxil
Paxil As We Know It Today

Read more HERE

Fid

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GSK’s $15m fees data go online

Image: ght.org.uk


The Financial Times is reporting that GlaxoSmithKline paid a staggering £9 Million in speaking and consulting fees to US doctors in the second quarter of this year.

GSK's website now shows 121 pages listing more than 3,700 doctors who had received fees for work including speaking to other doctors, appearing at conferences and consultancy.

The Financial Times writes:

"The details are published as pressure intensifies for the industry to highlight substantial support to doctors, whose authority can help prescription sales. Different draft US healthcare bills threaten to make disclosures compulsory."

This documentary made by investigative journalist, Shelley Jofre, further highlights how influential key opinion leaders are paid by Glaxo to basically promote the use of their drugs.


Watch Seroxat in News  |  View More Free Videos Online at Veoh.com
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By Bob Fiddaman

ISBN: 978-1-84991-120-7
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Glaxo Said to Have Paid $1 Billion to Settle Paxil/Seroxat Lawsuits

Image: i.dailymail.co.uk


Bloomberg is reporting that GlaxoSmithKline has shelled out almost $1 billion to settle lawsuits over Paxil [Seroxat] since its introduction to the population in 1993. $390 million is reported to have been paid out to settle lawsuits regarding suicides or attempted suicides said to be linked to Glaxo's Paxil [Seroxat]

According to the Bloomberg article, Glaxo so far has paid $200 million to settle Paxil/Seroxat addiction and birth-defect cases and $400 million to end antitrust, fraud and design claims.

Glaxo declined to confirm the $1 billion figure. “Paxil has been on the market in the U.S. since 1993. Like many other pharmaceutical products, it has been the subject of different kinds of litigation over the years,” said Sarah Alspach, a spokeswoman for Glaxo, in an e-mailed statement. “It would be inappropriate and potentially misleading to aggregate payments in these various types of litigation.”

Bloomberg add:

450 suicide-related Paxil cases were settled. Only about a dozen haven’t been, the people said. The $1 billion total doesn’t include more than 600 claims that Paxil caused birth defects.

Dan Carlat, a psychiatrist at Tufts University School of Medicine in Boston who writes and edits a blog and a monthly Psychiatry Report, added:

“It’s important to disclose such settlements because it raises the red flag for both doctors and patients that there might be a problem. It would motivate doctors to dig into the literature even more before prescribing these drugs.”

In GlaxoSmithKline's 2008 annual report officials noted that they had reached a “conditional settlement agreement” in January 2006 with Paxil/Seroxat users who alleged they suffered withdrawal symptoms after taking the drug.

You can read the full Bloomberg article HERE

Meantime, a UK Group Action lawsuit against GlaxoSmithKline trundles along with the claimants alleging that they all had difficulties withdrawing from Seroxat. On 19 May 2009 the High Court ordered that any individual who wishes to pursue a compensation claim must join the Group Action before 15 January 2010.

Seroxat is the most widely reported SSRi for adverse reactions according to the MHRA website.



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US Kids Represent Psychiatric Drug Goldmine

Image: Jared Rodriguez / t r u t h o u t; Adapted: zaxl4, Thom Watson)


New article from Evie Pringle:

US Kids Represent Psychiatric Drug Goldmine

Parents can now have their kids declared disabled due to mental illness and receive Social Security disability payments and free medical care, and schools can get more money for disabled kids. The bounty for the prescribing doctors and pharmacies is enormous and the CEOs of the drug companies are laughing all the way into early retirement.

Read more HERE

Evelyn Pringle is an investigative journalist focused on exposing corruption in government and corporate America. She won multiple awards for her investigative reporting from the International Center for the Study of Psychiatry and Psychology.

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DEAR DOCTOR, DO YOU KNOW WHAT YOU ARE PRESCRIBING?

Image: webmd.com


A good friend and fellow advocate recently carried out an experiment at their local Doctor's surgery. The aim of this Q&A session with their Doctor was to highlight just how much Doctor's know about the SSRi's they prescribe, how much they know about the side effects and how much they know about reporting these side effects.

As suspected, this particular Doctor chooses not to prescribe Seroxat any more, you will see why with the following.

The results were startling!

Q: - Do you think depression is caused by a chemical imbalance?
Reply: Yes.

Q: - Can you give me any evidence of this?
Reply: Well it is in the papers that GPs read regarding drugs etc. That is what we are told.

Q: - Who by?
Reply: As I said we look at medical journals etc.

Q: - I don't think so, as there is no scientific evidence to support this theory. Is it what the drug company reps have told you?
Reply: Yes, I suppose so. But I didn't think you were coming here for an arguement.
[I told him it makes me very angry that GPs are prescribing SSRIs on this basis etc.]

Q: - What do you think of the Yellow Card System?
Reply: Well it is quite a good system.

Q: - Why doesn't this surgery advertise the fact that patients can report ADRs themselves?
Reply: Umm Ahh. If I was to report every ADR I would spend the whole day filling out Yellow Cards.

Q: - Yes, but patients can report themselves now. Would you be willing to put up a poster and have Yellow Cards displayed in the surgery?
Reply: Yes, I suppose so.

I answered, "Good, I will bring you a poster and some yellow cards."
He then showed me a yellow card in the back of the BNF and asked if I would like one!

I answered, "No, I have lots at home."

Q: - So what ADRs do you report regarding SSRIs?
Reply: If I reported every ADR such as nausea, vomiting, dizziness etc I would not have the time for anything else. Anyway, the MHRA only ask for serious ADRs to be reported. I only report on Black Triangle drugs.

Q: - Really, so you really believe that you are only supposed to report on Black Triangle Drugs?
Reply: Yes, that's what it says on the Yellow Card in the back of the BNF.

I replied, "I don't think this is what the MHRA are aiming for at at all but I will tell them what you have said, not mentioning your name or the surgery because I appreciate that you have answered my question honestly."

Q: - Do you adhere to the NICE guidelines on SSRIs?
Reply: Well they are always changing the guidelines so not really.

Q: - Have you seen the latest guidelines that came out in October this year? There is a lot of new info about SSRIs, especially withdrawal?
Reply: No. GPs do not generally look at the NICE guidelines.

Q: - Why is that - because they are only guidelines and don't have to be adhered to?
Reply: Well, yes.

He said that the surgery does not prescribe Paroxetine [Seroxat/Paxil] anymore due the controversy in the media etc. They have switched to other drugs such as Citalopram [Cipramil], Prozac and Venleafaxine [Effexor].

----

Let's scrutinise this Doctor's answers.

This Doctor thinks depression is caused by a chemical imbalance, he adds weight to his belief because, "...it is in the papers that GPs read regarding drugs."

The papers that Doctor's read are, in the main, written [or ghost-written] by influential key opinion leaders who are paid by pharmaceutical companies!

Here's how Glaxo promoted Paxil [Seroxat] on TV in 2002. Here they claim that "a chemical imbalance could be to blame" and that "Paxil works to correct this imbalance."



Next, the Doctor lays claim that the Yellow Card System is, "...quite a good system."
He later adds, "...the MHRA only ask for serious ADRs to be reported. I only report on Black Triangle drugs."

This, to my knowledge is NOT true. The MHRA ask for ALL adverse drug reactions to be reported and NOT just the 'serious ones.' Why would a Doctor think otherwise?

He was asked whether or not he adhered to the NICE guidlines with regard to new information about SSRi's. His answer was kind of worrisome. "Well they are always changing the guidelines so not really." He added, "GPs do not generally look at the NICE guidelines."

Finally, the Doctor stated that he did not prescribe Seroxat any more due to the controversy about it in the media. He added that his surgery have switched to other drugs such as Citalopram [Cipramil], Prozac and Venlafaxine [Effexor]

I wonder if this Doctor thinks Cipramil, Prozac and Effexor are more safer than Seroxat?

Although this experiment cannot be classed as 100% proof that Doctor's are being duped and kept in the dark about the safety of these drugs, it does, however, highlight the incompetence of our medicine regulator, the MHRA.

It is plainly obvious, to me at least, that they are NOT promoting drug safety. They are NOT doing enough to educate Doctor's with regard to prescribing this class of drugs and they are clearly misguided about the 'success' of their deeply inaccurate reporting of adverse drug reactions.

With so much effort to stop the sales of online drugs and clamping down on herbal medicines, one would think that the MHRA could spend the money they receive from pharma in a way that actually protected the patient rather than protect the sales of pharmaceutical products.

I wonder if the Doctor who was interviewed is aware that Seroxat is classified as a Class D drug in the United States? [See Fig1] A class by the FDA's Pregnancy Category Definition that states: "Clear evidence of risk in humans. Studies, adequate, well-controlled or observational, in pregnant women have demonstrated a risk to the fetus." [See Fig2]

It would appear that even the UK regulator dispute the FDA's findings.

And MHRA CEO, Kent Woods, wonders why I criticise!


Fig1




Fig2


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GlaxoSmithkline Shuts Down Unit

Image: i.ehow.com

Prokerala.com is reporting that GlaxoSmithKline have "temporarily" suspended operations at one of its factories located in Dowlaiswaram, Andhra Pradesh, India because of civil unrest regarding the proposed division of the state.

In a statement they said:

"The management of GlaxoSmithKline Consumer Healthcare has decided to suspend operations temporarily at one of its factory located at Industrial Estate Dowlaiswaram, in the interest of safety of its employees and to protect the assets of the company."

Maybe they should hand out FREE Seroxat to its employee's, then ask them to taper using the Patient Information Leaflet as a guidance.

I guarantee their employees will find an inner rage and lose any fear of confrontation. Then again, some of them may have suicidal thoughts, some of them may even carry out those thoughts.

Incidentally, an anagram of paroxetine is AXE PROTEIN.

Strange but true.

Fid

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The End For European Medicine Regulators?

Image: cientifica.eu


I was sent a link by a reader of Seroxat Sufferers that, if true, could have severe implications for those taking prescription drugs in the UK and rest of Europe.

The website, prescrire.org, is predominantly written in French, however the following has been translated into English.

The post was made on the 1st December, 2009 and, if true, will leave you shocked and stunned at the latest European Commission proposal.

It would appear that they wish to hand over post-marketing monitoring to the pharmaceutical companies, the same pharmaceutical companies that have a history of covering up adverse reactions that harm the sales of their products!

Prescrire writes:

Confronted with this fundamental problem, rather than attack the causes (including inadequate risk evaluation before drugs are approved), the European Commission has proposed a dangerous reform of the pharmacovigilance system. The Commission plans to turn the problem over to the very parties who have a strong direct interest in burying it: pharmaceutical companies.

You can read the article for yourself here

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Paxil Changes Your Personality

Image: api.ning.com

I can't argue with the title to this post. Paxil [Seroxat] does indeed change your personality.

It appears that it changes it for the good, if a recent study is to be believed.

The study, 'Personality Change During Depression Treatment' appeared in the Archives of General Psychiatry - Vol. 66 No. 12, December 2009.

In a nutshell, the study found no significant differences between the two active treatments, the SSRI paroxetine [Paxil/Seroxat] and cognitive behavioral therapy [CBT]. But both paroxetine and the CBT treatment outperformed placebo in changing depression, neuroticism, and extraversion scores significantly. [1]

Peter D. Kramer, the psychiatrist and author of the 1993 book 'Listening to Prozac,' has said that he felt "vindicated" by this newly published study. The LA Times reports that Kramer thought this study might have been funded by the makers of Paxil/Seroxat, GlaxoSmithKline. However, to back up his [vindication] the LA Times reports that the study was funded by Northwestern University initially, and then continued under a pair of grants from the National Institute of Mental Health.

So, all seems well in Peter Kramer's world - he feels vindicated that this study has proved him right.

Let's try not to rain on Kramer's parade here... I prefer the term 'Piss on one's cornflakes.

On Monday December 1st, 2003, Emory University, GlaxoSmithKline, and National Institute of Mental Health Create Partnership announced that they were going to develop new treatments for depression.

Wait a minute... The National Institute of Mental Health?

The same institute that continued the 'Personality Change During Depression Treatment' study?

Yes, you read correct folks.

Strange that Kramer doesn't mention this whilst blowing his own trumpet at his vindication.

We all know of Emory University and their connections with GlaxoSmithKline and Paxil/Seroxat don't we?

Here, Emory researchers found Paxil/Seroxat improved memory and brain structure in people with post traumatic stress disorders.

More worryingly, here, we find that Charles Nemeroff, prominent Emory University psychiatrist, failed to tell the Emory officials about $500,000 he received from GlaxoSmithKline while heading a government-funded research project studying Glaxo drugs.

I think we can safely say there is a conflict of interest here.

But what of The National Institute of Mental Health?

Well, scientists from Emory University School of Medicine, GlaxoSmithKine (GSK), and the National Institute of Mental Health (NIMH) have worked together since 2003 to accelerate the development of drugs to treat depression and other mood disorders. They were funded through a $4.9 million, five-year grant from the National Institutes of Health.

When I hear of Paxil/Seroxat being heralded as this or that, I tend to think there is a conflict of interest. It's a risk vs benefit thing with me you see. I like to weigh up the evidence that is out there and not the evidence we are just told to accept.

Kramer conveniently forgets to mention the on-going partnership between GSK, Emory and the National Institute of Mental Health.

See for yourselves here

Maybe Kramer just didn't know?

Enjoy those cornflakes.


[1] Personality Change During Depression Treatment


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MY REPLY TO MHRA CEO, KENT WOODS

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Following on from Kent Woods email to me yesterday regarding my criticism of the MHRA.

I would now like to offer you my response.

Before doing so I would like to point out the related links to Kent Woods at the foot of this post.

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CEO of MHRA, Kent Woods, responds to criticism.

I have received a response from the CEO of the MHRA regarding the recent teratogen correspondence

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"Paxil on Trial: Antidepressants, Kids & Birth Defects"

Image: schmidtandclark.com


Lawyers, doctors and a law professor argue the merits of a recent Philadelphia case where a woman prevailed in her claim that an antidepressant that she was taking caused severe harm to her child. Attorneys Jamie Sheller, Anthony Marchetta, Drexel Health Law Professor Barry Furrow and Rajnish Mago, MD of Thomas Jefferson University Mood Disorders Clinic answer viewer calls at 1-800-426-4526.

Viewer calls are screened and moderated. Please call only with questions that would help other viewers. Visit the program’s Facebook page, The American Law Journal, to share your story and post your thoughts.

You can watch this on Monday, December 7th - 7-8pm US EST at the following link:

www.wfmz.com

Jamie Sheller, Esq., one of the attorneys in the recent $2.5 million Paxil birth defect verdict will be on the show.


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WARNING SLAMMED ON DEPAKOTE!

Phil Dawdy over at Furious Seasons is reporting that Depakote, Abbott's widely-used anti-convulsant for epilepsy and bipolar disorder was today slammed with a major warning from the FDA.

Dawdy is bemused as to why this has not made the major press outlets in the States.

Thanks Phil, for keeping an eye on things over there.

Read his article, FDA Issues Major Birth Defects Warning For Depakote, HERE

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European Regulators And Their Conflicts Of Interest

Image: randi.org


Ed Silverman over at Pharmalot writes about the conflicts of interest involving the pharmaceutical industry, the Irish Medicines Board, the Medicines and Healthcare products Regulatory Agency and the European Medicines Agency.

Findings, published in Social Science & Medicine, suggests there is reason for concern.

They found that the MHRA executive board since 2004 had five people who had industry backgrounds before joining the agency, one went on to an industry job after leaving and one participated in research funded by a drugmaker before joining the MHRA. In total, seven of 25, or 28 percent of MHRA personnel had a relationship with drugmakers.

“We found that of the 26 chairs of various Working Groups, Panels and Expert Advisory Groups 15 had personal interests, 12 had non-personal interests, 6 had both personal and non-personal interests and 10 had neither type of interest,” wrote the researchers. “Our review of the publicly available declarations of interests of the EMEA Management Board found that 25 percent of members declared interests in the pharmaceutical industry…

Read Ed's article HERE

Related links:

TALES OF THE PAROXETINE TERATOGEN BY BOB FIDDAMAN

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Pfizer and MHRA Pushing the Boat Out With Message

It would appear that there is a lot of money being splashed around by pharma giants Pfizer with regard to them 'helping' curb the popularity of people buying prescription drugs online.

The latest, in what seems to be a massive PR exercise, sees a new website called, 'REALDANGER. Get Real, Get a Prescription.'

The venture is led by Pfizer but has gained the support of, amongst others, the MHRA.

One would think that the MHRA have more important things to deal with, if their yellow card adverse reports are to be believed.

The latest number of reported reactions for Seroxat is 32,100 with a reported 169 deaths.

The image Pfizer are using to promote this initiative could also be used for those 169 people.


Image: realdanger.co.uk

Forgive me for being cynical but I do think the MHRA seriously need to get their house in order before they start proclaiming that 'fake drugs' are inferior to the ones that are currently under licence from them!

**Pfizer are the makers of Viagra, a drug that has been targeted by counterfeiters online.

Related posts: Is Seroxat a Teratogen?

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Update on my book

Image: summit.k12.co.us


It's pretty hard to juggle in between blog posts and the book I've been writing. Today I drafted three Chapters, up to 18 so far and over 58,000 words.

I find it easier once I knuckle down. It is still in its infancy with regards to the way books are written [or should that be wrote?]

Anyway, it's basically about my journey so far- the trials and tribulations of writing a blog, corresponding with the Medicine regulator and of course GlaxoSmithKline.

I have no idea when it will be finished, maybe it will be Part I and another book will follow?

Who knows?

Anyway... until then

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Angry Parent Sends Letter to School Re: GSK's Cervarix Vaccine

Image: pharmamarketeer.nl


Quite a superb letter from an angry parent was sent in to the Headmaster of The Thomas Aveling School, in Kent, UK.

The letter appears on the blog Everyday Catholic Woman and highlights many of GlaxoSmithKline's misdemeanours.

The letter, which is a fine example of research finishes with:

My daughter REDACTED will no longer be vaccinated by anybody through your school, as this major Pharmaceutical Cartel (GlaxoSmithKline) cannot be trusted with the welfare of our children and as the Treasonous criminals who are currently employed by the United Kingdom Corporation have consistently abused their powers and deceived the people of this fine country.

If you have any question, queries and concern do not hesitate to contact me. I trust that you understand my wishes so the matter will not need to be taken further.

Yours sincerely,


REDACTED
(Father of the child)

The full letter can be read HERE

Related links:

Cervarix Tested For Boys!

GlaxoSmithKline challenged safety Cervarix anti-cancer vaccine left girl partially paralysed

4,602 Suspected Adverse Reactions to GSK's Cervarix!

Girls used as Guinea Pigs in HPV Trials Admits GSK

GSK - A Catalogue of Disasters!

Glaxo: "Promote More, Feel Better and Live a Life of Luxury"

Glaxo Goes Head-to-Head on HPV

Teenage Girls Sue Over GSK's Cancer Jab, Cervarix!

GlaxoSmithKline submits final study data to FDA for cervical cancer vaccine

HPV Vaccine Video on Youtube

Concerns over GSK's Cervarix vaccine

UP YOURS GLAXO!

Mindy Merck & Gail Glaxo Dilemma

LOLA'S LAND PROMOTING HPV VACCINE

GlaxoSmithKline's Cervarix. Is Your Daughter Safe?

More debate on GSK's Cervarix

Cervical Cancer, Ofsted & GlaxoSmithKline

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SEVERING TIES WITH THE MHRA

It seems uncanny that the first ever post on this blog, back in 2006, was to highlight the failings of the MHRA. Over three years has passed since that first post, 3 years, 7 months, and 16 days, 1,326 days, to be exact.

I was quite shocked when I worked this out. I've been writing for that length of time about something I am passionate about. I don't get paid for what I write, quite a lot of man hours put in for voluntary work one would think.

During these 3 years, 7 months, and 16 days the MHRA have investigated the safety and efficacy of Seroxat and other SSRis/SNRi's. Each time, they have concluded, that the benefits outweigh the risks.

On the 6th March 2008, the MHRA issued a press release, 'GSK investigation concludes'

Part of that statement reads:

The MHRA has concluded its four year investigation into Glaxosmithkline and its antidepressant drug Seroxat. The investigation focused on whether GSK had failed to inform the MHRA of information it had on the safety of Seroxat in under 18’s in a timely manner.

The investigation was undertaken with a view to a potential criminal prosecution for breach of drug safety legislation. It was the largest investigation of its kind in the UK, and included the scrutiny of over 1 million pages of evidence.

The decision taken by Government Prosecutors, based on the investigation findings and legal advice, is that there is no realistic prospect of a conviction in this case, and that the case should not proceed to criminal prosecution.

It continued with:

Professor Kent Woods, MHRA Chief Executive, said: “I remain concerned that GSK could and should have reported this information earlier than they did. All companies have a responsibility to patients, and should report any adverse data signals to us as soon asthey discover them. This investigation has revealed important weaknesses in the drug safety legislation in force at the time.

It is interesting to note that the deflection away from the behaviour of GlaxoSmithKline is directed toward the drug safety legislation in place at that time.

It is also interesting to note that in the four paragraph press release the MHRA choose not to chastise GlaxoSmithKline.

I, along with others, was never happy with the way this investigation was handled and, as with others, I made my feelings clear on this blog and in various other forms of communication with the MHRA. It was, however, something that I and others had anticipated.

The one chance at a criminal prosecution being brought against GlaxoSmithKline, scuppered by an antiquated drug safety legislation. To put it into layman's terms, The MHRA and GlaxoSmithKline had squared up for a fight in the ring. GlaxoSmithKline won on points. There was to be no re-match.

The response from GSK into the MHRA's conclusion of this 4 year investigation was more like a 'thank you' note if one reads between the lines. It smacked of smugness and a severe lack of conscience.

Both the MHRA and GlaxoSmithKline rode the storm that ensued, "Today's newspaper is tomorrow's fish and chip paper."

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MHRA Response: Limp-Wristed and Cowardly

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So here is the response the MHRA gave me.



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Is Seroxat a Teratogen? : All in 15 Days work

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It is important, before you continue to read on, that you read the first part of this particular correspondence with the Medicines Healthcare and products Regulatory Agency [MHRA] HERE

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Response From MHRA - "Is Seroxat/Paxil a Teratogen?"

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I first started writing this blog in 2006. I was basically frustrated at the lack of transparency coming out of the MHRA - My first post pointed to a story from 2004, it was, in essence, an article by Richard Brook giving the reasons as to why he resigned from the Expert Working Group who reviewed the safety of antidepressants.

Brook was then the CEO for the mental health charity, MIND, and he had accused the MHRA of failing in its duty by not acting on data showing that thousands of people were taking unsafe doses of Seroxat.

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The Story of GlaxoSmithKline The Company Contracted to Make Your H1N1 Vaccine

Just found this on youtube.

Here's the blurb from Sharp Edge Studios, who made the video:

"This video was made to be displayed at the University of Windsor in the CAW center one day before the H1N1 vaccine clinic opens on November 26th. It was made to inform the public about GlaxoSmithKline before they decide to get the H1N1 flu shot."



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Is Seroxat a teratogen. GSK: "discuss your concerns with your doctor"

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Part III of this on-going saga.



I've had another reply from GlaxoSmithKline regarding the question I put to them last week.

'Is Seroxat a teratogen'?

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The GSK Teratogen Plot... Thickens!

Image: blog.prescriptionaccess.org



Bizarre behaviour happening over at the enquiries desk at GlaxoSmithKline. They still have not answered a question I put to them - Is paroxetine a teratogen?

Teratogen: Any agent that can disturb the development of an embryo or fetus. 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.

Following on from yesterday's answer, where they apparently included a response in an attachment to me via email, they, today, wrote the following to me:

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GSK Response to Teratogen question - Laughable

Image: e-architect.co.uk



Well, I have kind of seen every trick in the book now...

A few days ago I wrote to GlaxoSmithKline enquiries to ask a simple, yet very important question.

Is paroxetine [Paxil, Seroxat] a teratogen?

To be honest I didn't think they would answer me, and even if they did they would probably direct me to part of their website where one would need a degree in bio-chemistry to fathom out what was written.

I was wrong.

Their response was far more off the wall than the above.

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Art Auction for Paxil Heart Defect Victims

The Bitter Pill, the Official Blog of UNITE – uniteforlife.org, is running a campaign for the parents of Manie, a child born with Transposition of the Great Arteries.

The family has a case pending against Glaxosmithkline for Manie’s heart defect caused by Paxil. The case, like so many against GlaxoSmithKline, is moving along at a snail's pace and medical and travel expenses for Manie are hitting the family hard.

Manie needs this treatment and his family need help with the expenses. GlaxoSmithKline deny that Paxil causes heart defects, despite being found guilty in the recent GSK v Kilker trial - a decision that they are appealing against.

There are approx another 630 cases pending with regard to Paxil causing heart defects in children. Rather than do the right thing [admit liability] Glaxo are choosing to dig in their heels and plead their innocence. Meantime, folks like Manie's parents are faced with the daily struggles of juggling money for their child to survive.

The legal system needs changing. If a company or person is found guilty of manufacturing a harmful product then they should compensate the victims whom that product has harmed or at the very least pay for the travel and medical expenses!

Manie's mother, Julie, tells her story of her son's plight on the excellent blog, 'Big Pharma Victim'

To make ends meet the family is now auctioning off some of their artwork, some of which can be viewed HERE

Ten percent of the sales will be donated back to the UNITE / MADNAP cause for public awareness to help save other babies. For more information on how UNITE / MADNAP utilize donations send an email to amy@uniteforlife.org

To donate commissioned artwork or other goods to this auction, contact Julie & Russell at give2manie@yahoo.com

To read more on the previous Paxil/Birth Defect trial click HERE

To read about the teratogen link in Paxil read HERE


Here is a short clip of Manie at hospital a couple of days after airtubes were removed.



Hat - Tip: Amy Philo


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Paroxetine - The Teratogenic Effect by Bob Fiddaman

Now there's a word, "Teratogenic" - one most of you will be unaware of - one that has caused me considerable confusion over the past few weeks. I shall explain.

The recent GSK vs Kilker case saw files flood the Internet, many of which, if not all, are featured on this blog and my sister blog, GlaxoSmithKline Internal Files

What I find astounding is that this word, "Teratogenic" and/or "Teratogen" often appears throughout the Kilker files. A quick search of the word/s simplifies it into laymans terms:

Teratogenic: Able to disturb the growth and development of an embryo or fetus.

Teratogen: Any agent that can disturb the development of an embryo or fetus. 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.

What has caused me much confusion over the past few weeks is the lack of help I have received trying to find out more about the paroxetine [Paxil, Seroxat] and teratogen link.

The Kilker case files show a link between paroxetine and its teratogenic effect, such a strong link that the jury in that case found that paroxetine was the causation of young Lyam Kilker being born with heart defects.

As a patient/concerned UK citizen I have tried to ask questions regarding this link.

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Seroxat: Risk v Benefit - Kevin's Story

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I stumbled across this fascinating story of one man and his time on GlaxoSmithKline's Seroxat. It fascinates me in as much as the author, 'Kevin', seems to be a very articulate who writes skilfully and, I'm sure you will agree, without bias.

It's difficult, for me anyhow, to deem whether or not this is a Seroxat success story, indeed if any one person's time on Seroxat can be deemed a success, particularly when one experiences the 'risks' as opposed to the benefits.

Kevin eloquently puts his points across.



Reproduced in its entirety with permission from Social Anxiety UK


Kevin's Story


If it’s something you have never tried, then it’s something you will surely be aware of by now. Seroxat, the drug used to help treat both depression and anxiety has been causing a stir in the mainstream media, derided for it’s alleged link with suicide cases.

Of course, what many scribes tend, or choose, to ignore that people will turn to the drug as a last resort to help them climb out of depression and possibly allay suicidal thoughts.

Whatever, anyone still reading this probably wants the answer to one question: does it work?

Well, before attempting to answer that I must supply the obligatory disclaimer. I am NOT a doctor; I don’t claim to be, and I don’t claim to be an expert on anything drug-related. There is one thing we’re all an expert on, and that is knowing our own experiences, and that is what I intend to share.

To the question above, you will, unsurprisingly as it’s a ‘yes’ or ‘no’ question, usually receive one of two answers. Sadly for you, I’m going to take the mantle of that annoying itch on your buttocks and answer “yes… and no”.

I started taking Seroxat in early 2001. I’d been suffering from what I eventually came to know as Social Anxiety (SA) for approximately seven years, fluctuating in school between the popular guy who mixed with all crowds and banged in goals for the football team, and the misfit who avoided speaking to anyone and didn’t really do anything at all. In college my attendance eventually dropped to 40% for all my classes, and when I went to Essex University for three months I didn’t attend anything at all. I’d been to a private psychiatrist, albeit briefly, prior to going, and I’d made my parents well aware that without something else, without some sort of a treatment, there was no way I would make it beyond a few weeks.

So I saw my local GP when I arrived back home, and with the NHS not being particularly useful in fixing me up with a psychiatrist, he reluctantly prescribed me this ‘wonder drug’. I’m not entirely sure how the reluctance arose; I mean the potentially negative aspects of the drug will surely have been well-circulated amongst the medical community; but then again he was keen to stress it was important not to rely on it as a crutch. Either way, put me on it he did, and to be quite honest, fuelled by it I had the greatest summer since I was a primary school kid. I didn’t go on holiday anywhere; just a stack of nights out with mates, and of the side effects extensively listed in the pamphlet I had my fair share. But it gave me such freedom; after time I didn’t have to worry about waking up the next day too afraid to leave my house, or too afraid to answer the phone.

Never did I think penis-related difficulties and insomnia would be paradise, but, compared to what I was experiencing before, that’s exactly what it was. But these side effects didn’t last that long, maybe three months or so. There are plenty of others, which I escaped; nausea, headaches and loss of appetite to name a few. It seems they’re inevitable, but a lottery as to the ones you get. Test one is valuing the potential benefits of Seroxat against these side effects. Personally, the exhaustion of the sleepless nights and the, uh, discomfort of impotence was nothing compared agony of facing an everyday social situation.

At the onset of autumn 2001, I was back at university, this time Staffordshire, with a renewed confidence. For the first time I was entering an academic year free of the constraints of my SA. Seroxat, to this point, had been saving my life. But it didn’t last. After six months, this was the first time I had been back, consistently, amongst society. For the last six months I had chilled out at home, living at my own pace. As soon as I was back under social pressure, amongst people I didn’t know, the effects of Seroxat slipped, hence the “…no” aspect of my earlier answer. Of course I can only relay my own experiences, and in my case Seroxat only seemed to work when I knew I could enter social situations at my own free will, when I wasn’t being forced to do so via circumstances on a daily basis.

It may have continued to help to a degree. My SA has always fluctuated. Some people who have only met me once or twice would describe me as hilarious, confident while showing great humility, as well as open yet polite, and tremendously sociable. Others would say I’m passive to the point of rudeness, and verbally clumsy in conversation, losing my train of thought and not paying great attention in conversation. I know which ‘me’ I prefer, but even with Seroxat I can’t achieve that consistently. Continuing to take it for a few months I was able to sustain a 66%-good record for a while, but this dipped and by Christmas I was back down to, at best, 50-50. I even took the unadvised route of taking five pills a day instead of the maximum dosage of three, desperate to regain the normality I was living throughout the summer.

After my SA took unmanageable control I dropped out once again.

Last year and this, my SA has been just as bad. But somehow, I don’t know how, I’ve fought it with inner strength that I hadn’t found before. In the past, pre-Seroxat, I had forced good spells by just being out there, be it at school, college or forcing myself out socially with my mates. I’m forcing myself into social situations now more than any other time in the last three years, and more consistently than ever since I finished college four years ago. I still get desperate, and dabble with periods of Seroxat when I feel desperate. But I’ve done so enough times now to know that it will never have the same effect as it did back when I first started taking it. Unless I experiment with an alternative at some stage, I’m battling SA with my own homemade weapons for the foreseeable future.

To someone seeking medication and wary of but willing to face the early side effects, Seroxat may be worth a try. Whether it works for you or not, one must be very careful when coming off it. I hadn’t entirely trusted the journalist hyperbole about its failings until late last year, and I still don’t really, but then I experienced its potential dangers for the first time. I had been struggling immensely, forcing myself to class as much as possible but slipping too often. I was back on it for a few weeks, taking, again, an unrecommended dosage. No luck. The day I came off it I was hit by incredible panic. Suddenly, I was asking myself what the point was. Suddenly, the reality of my situation was I was fighting a pointless battle. I hadn’t felt this way for two years; and back then no-one understood my situation. It made sense to panic; but this time it didn’t. But, whether or not it was the Seroxat making me delusional, rationality wasn’t something I particularly cared about.

That was the only time I have ever truly come close to suicide. I had emptied several weeks’ dosage of Seroxat into a glass, along with 50-odd paracetemol. I’m quite sure I would have gone through with it, too, but a random phone call from a friend, catching me in floods of tears, probably saved my life. I came out with dismissive rhetoric (“if I tell you I’m not going to do it will you go away?”) but the call itself disrupted my loneliness for long enough for the adrenaline to subside.

The timing was too coincidental too be anything but withdrawal. If anything it’s taught me a lesson to pass on: be careful, be responsible. You’re taking Seroxat to help you control your life, don’t let it control you.

Original story can be found on the Social Anxiety UK website

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