Zantac Lawsuit


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

Thursday, December 31, 2009

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' By Bob Fiddaman
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Wednesday, December 30, 2009

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

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Tuesday, December 29, 2009

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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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Monday, December 28, 2009

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

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Sunday, December 27, 2009

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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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Friday, December 25, 2009

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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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Wednesday, December 23, 2009

MERRY CHRISTMAS TO ALL MY READERS

Clipart



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

Clipart



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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Tuesday, December 22, 2009

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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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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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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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Monday, December 21, 2009

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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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Sunday, December 20, 2009

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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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Friday, December 18, 2009

**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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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Wednesday, December 16, 2009

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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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Tuesday, December 15, 2009

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
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

Monday, December 14, 2009

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.



Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Sunday, December 13, 2009

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.

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Saturday, December 12, 2009

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


Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Friday, December 11, 2009

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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Thursday, December 10, 2009

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

Fid

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Wednesday, December 09, 2009

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


Fid

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Tuesday, December 08, 2009

MY REPLY TO MHRA CEO, KENT WOODS


Image: angela-stevens.com



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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Monday, December 07, 2009

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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Saturday, December 05, 2009

"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.


Fid

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Thursday, December 03, 2009

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

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Tuesday, December 01, 2009

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

Fid

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Please contact me if you would like a guest post considered for publication on my blog.