Monsanto Roundup Lawsuit

Sunday, June 29, 2008

A death without warning

It was a bewildering and catastrophic slide into the abyss of depression, which Nelson businessman Peter Noonan did not find his way out of. Gaile and Crissie Noonan talk about their experience of coping with suicide, in the hope that it prevents others having to deal with a similar tragedy. Tracy Neal reports.

Nelson coroner Ian Smith said in his findings that Peter was prescribed the selective serotonin re-uptake inhibitor anti-depressant drug Aropax days before his death in July, 2006.

FULL STORY HERE

Seroxat is known as Aropax in Australia and New Zealand

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

Friday, June 27, 2008

Are the MHRA NOT complying with EU guidance?

It seems the MHRA are failing to follow the guidance of the European Union (EU) regarding patient information leaflets in the UK. Ironic really as I have been banging the drum quite loudly in the direction of the MHRA to change the Seroxat Patient Information Leaflet. Well, it now appears that they are not only ignoring me (a concerned patient) but the EU guidelines too!

After they investigated (Ahem!) GSK they told us they could bring no prosecutions due to EU Law. I'm now using the EU excuse at them!

Question: Why are the MHRA failing to follow the EU guidelines regarding the adequacy of Patient Information Leaflets on Adverse Effects?

I will explain.

It appears that anecdotal evidence suggests that most leaflets give little indication of the likelihood of adverse effects. The MHRA suggests using a combination of words and numbers to convey this information.

The EU guideline on this matter is clear, they suggest using five verbal descriptors on a scale from common to rare leads to lead to gross overestimation of the risk of adverse effects.

A recent assessment (Authors: Carrigan, Neil1; Raynor, D.K.1; Knapp, Peter1) showed that 40% of 50 Patient Information Leaflets studied gave no indication of the likelihood of adverse effects occurring.

More worrying was that only 12% of the 50 Patient Information Leaflets studied used the recommended EU terms and a further 40% used a wide range of other verbal descriptors.

Only four leaflets (8%) provided any form of numerical indication of risk!

The conclusion of this assessment can be read in abstract form here.

Conclusions: Patient need is not being met in terms of the provision of usable information about the likelihood of adverse effects. Most patients receive no information, whereas some are given verbal descriptors, both of which lead to overestimation of the risk. Very few of the patient information leaflets assessed used currently described best practice, i.e. to present verbal descriptions alongside numerical information in the form of natural frequencies, e.g. `rare (affects less than 1 in 1000 people)'.

I have wrote to the MHRA with a simple question, a copy was also sent to my MP, Gisela Stuart and the CEO of the MHRA, Kent Woods.

Why are the MHRA failing to follow the EU guidelines regarding the adequacy of Patient Information Leaflets on Adverse Effects?

The MHRA proudly boast on their website:

"We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks."

Their answer should prove interesting.

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

Thursday, June 26, 2008

The true state of comments to GSK's weight loss petition

Source: Food Navigator

By Lorraine Heller

18-Jun-2008 - Last week, NutraIngredients-USA.com mistakenly reported that comments to the GSK weight loss petition were sparse. A re-examination of data reveals that public comments have been flooding in, with the large majority expressing strong opposition.

To date, there have been almost 600 public submissions in response to the citizen petition filed by drug firm GlaxoSmithKline requesting that weight loss claims be considered disease claims.

Filed on the regulations.gov website, these are principally comments from individual consumers, but also include submissions from health groups, consumer organizations, alternative medicine/treatment groups, academia, health professionals, and marketers of natural products.

A large majority of comments were filed using a standard letter prepared by consumer advocacy Citizens for Health, which urged its members to stand up for their rights to make purchasing decisions. The letter also directly implies that the petition is an attempt by the drug industry to remove the competition from dietary supplements.

Indeed, a general hostility and anger towards GSK and Big Pharma is evident in most of the submissions, which does not necessarily provide FDA with the crucial science-backed response that could counter the petition, but which does go a long way in gauging the public's feelings.

The request put forth by the petition has been called a "ridiculous idea" and a "ridiculous and self-serving claim".

"The drug company is obviously concerned about its bottom line and nothing more," runs the general thread. "It's very clear the pharmaceutical industry has undertaken a campaign to takeover the healthfood/supplement industry."

"It seems perfectly obvious to me that GSK is looking out for their own interests. They are not at all interested in 'protecting' the public," says one commentator that claims to be representing the organic retail giant Whole Foods.

Other thoughts commonly repeated include the consumer right to make choices for themselves, and the inappropriateness of classifying obesity as a disease state (the petition claims that although obesity is not a disease in itself, it is a significant risk factor for ailments like diabetes, cancer and heart disease.)

FDA's Lyle Jaffe, lead legal instruments examiner, division of dockets management, this morning confirmed that the list was "not an accurate reflection of what's in the docket".

The discrepancy, explained Jaffe, may be down to the petition-tracking code entered into the website (0001). He suggested that only the docket number (FDA-2008-P-0248) is used in future searchers, rather than the petition document ID (FDA-2008-P-0248-0001), which brings up the petition, but also an incomplete selection of public submissions.

To view the full list of comments, click here.

To comment on the petition, click here.


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

Alabama Sues GSK, Novartis for $800 Million in AWP Case

Source FDA News

Alabama Sues GSK, Novartis for $800 Million in AWP Case

The state of Alabama has begun its trial against Novartis and SmithKline Beecham, a subsidiary of GlaxoSmithKline (GSK), for as much as $800 million for allegedly overcharging Medicare, Medicaid and private insurers by inflating the average wholesale price (AWP) of drugs.

Read on


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

Sen. Grassley targets Stanford Psychiatrists Over Conflicts

Researchers Fail to Reveal Full Drug Pay

Senate Targets Stanford Psychiatrist Over Conflicts



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

Wednesday, June 25, 2008

New study about antidepressants – Big Pharma and medical agency working close together to save profits and careers

The news that antidepressants in actual fact don’t work better than sugar pills and increase the risk for suicide have filled major media the last year. Psychiatrists, Big Pharma and medical agencies, responsible for distorting the facts for many years, are now working hard to save profits and careers.
Sweden 6/25/2008 07:29 PM GMT (TransWorldNews)



Janne Larsson
Reporter – investigating psychiatry

Source: Transworld News

The new study, “A Regulatory Apologia - A review of placebo controlled studies of new-generation antidepressants”, claiming that antidepressants work well for all forms of depression should be seen in that light. It’s another good example of how alleged objective medical agencies work close together with the pharmaceutical industry and its paid psychiatrists to increase sales.

The study was announced in the journal of the Swedish Medical Association (Läkartidningen) April 15, 2008. In the article the longstanding advocate for antidepressant drugs Professor Björn Beerman from the Swedish equivalent to the FDA, the Medical Products Agency (MPA), promoted continued high level use of these drugs. Beerman did not believe in the data presented internationally and said (as many times before) “there is no doubt that the medication has effect and that this is independent of degree of depression”. He further stated that “the effect should be less good in milder depression, that we don’t believe in”.

In the article Beerman with pride announced the new study from the MPA; a study supposed to prove his statements. The study was said to be submitted for publication in the most prestigious medical journal on the planet, the Lancet.

But this part of the story needs to be told:

What Beerman didn’t say (April 15) was that the Lancet already, almost two weeks earlier, (April 4) had rejected the article – it was not to be published. The MPA then made another try, and submitted the data to the British Medical Journal (BMJ) – another journal with high impact. But the response was the same, the BMJ rejected the material.

So the agency – with its for Big Pharma so important “research message” – went directly to the manufacturers, or more correctly to a journal with an editor-in-chief who probably has meant more for the approval and sales of antidepressant drugs internationally than anyone else: The agency submitted its article to European Neuropsychopharmacology, with its editor-in-chief, Dr. Stuart Montgomery. And it was accepted.

For those not familiar with the work of Dr. Montgomery it can be said that he played a major role in helping Big Pharma to get new antidepressant drugs approved in the beginning of the 90-ties (despite that the actual data already at that time showed the drugs gave an increased risk of suicide). He was also responsible for the famous concealment of Seroxat/Paxil severe withdrawal symptoms. Instead of accepting the clear withdrawal symptoms so that patients and doctors could be warned Dr. Montgomery and colleagues misclassified these symptoms as signs of recurring depression – needing more drug treatment.

So a study with the PR-message that antidepressants work well for all forms of depression would most likely be very welcome in the European Neuropsychopharmacology. And it was. One of the reviewers of the article made the point very clear, saying: “This meta-analysis is very timely in the situation when the recent meta-analysis of Kirsch et al. (2008) induced a lot of uncertainty about the efficacy of antidepressants, both in the psychiatric community as well as in public opinion.” It was recommended that the article should be published “without any delay, given the situation mentioned above [“uncertainty … in the psychiatric community as well as in public opinion”].”

The MPA and its counterpart FDA have done almost nothing to use the wealth of data in its files to show the actual suicide risks with antidepressants, and to warn doctors and the public. (See the newly unsealed extensive analysis by Dr. Joseph Glenmullen of GlaxoSmithKline’s hiding of Seroxat/Paxil suicide data, as an example of how the pharmaceutical industry can act, and how ineffective and silent a regulatory agency can be in questioning the data in the drug applications http://finance.senate.gov/press/Gpress/2008/prg061208a.pdf , 4MB.) The lack of positive drug effects has always been denied by the MPA. The ineffective system for postmarketing surveillance of adverse drug effects is putting the public at severe risk – yet it is allowed unchanged year after year. The often horrible withdrawal symptoms of antidepressant drugs have been explained away as signs of recurring depression – and thus transformed to evidence of positive drug effects; and this manipulation has been accepted by the regulatory agencies. The MPA and the FDA, supposed to protect the public, are agencies out of control, and see the pharmaceutical industry as their real clients.

It’s first in a situation, where independent analyses of data submitted to the FDA show no positive effect of antidepressant drugs compared to placebo, that the Swedish MPA puts all its “research resources” in action to prove the opposite. The eagerness for collaborating with Big Pharma in getting out a PR-message, to handle the “uncertainty about the efficacy of antidepressants, both in the psychiatric community as well as in public opinion”, is yet another example of betrayal of the real clients – the public.


Janne Larsson
Reporter – investigating psychiatry

janne.olov.larsson@telia.com


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

Seroxat Linked To Dangerous Withdrawal Symptoms

Source HERE


I have substituted the word 'Paxil' for 'Seroxat' for the benefit of the English visitors to this site and for Google UK Web Crawlers.



Seroxat Linked To Dangerous Withdrawal Symptoms


Popular serotonin reuptake inhibitor (SSRI) antidepressant drug Seroxat has been linked to SSRI Discontinuation Syndrome, a severe and sometimes life-threatening condition that occurs upon withdrawal from the drug.


This is just one of many recent Seroxat side effects, such as complications in pregnancy, increased risk of suicide and serotonin syndrome, that have brought the drug and its manufacturer, GlaxoSmithKline, under fire.


What is SSRI Discontinuation Syndrome?


SSRI Discontinuation Syndrome occurs within 24 hours to one week of cessation of Seroxat or similar SSRI drugs. The syndrome is connected to a drug 's "elimination half-life", the period of time necessary before a pharmaceutical agent is completely out of a patient 's system.


Seroxat has a particularly long half-life and a higher incidence rate of SSRI Discontinuation Syndrome. While SSRIs like Seroxat have been touted as non-addictive, the withdrawal syndrome mimics some typical facets of withdrawal from addictive drugs such as alcohol or opiates and creates powerful symptoms including:


* Gastrointestinal disturbances, including nausea or diarrhea;
* Mood disorders, such as suicidal ideation (suicidal thoughts), tearfulness, mania, irritability and aggression;
* Sensory and movement disorders, such as vertigo, trembling, dizziness, tingling and numbness, difficulty moving or walking, and ringing of the ears (tinnitus); and
* Sleep disorders, such as fatigue, narcolepsy, insomnia or vivid dreams.


Since the withdrawal symptoms of Seroxat can be so strong, patients are encouraged to speak with their health care provider before going off the drug and are advised not to stop the drug suddenly.


An experienced Seroxat doctor can help you ramp down your dosage in appropriate amounts, tapering the dose off until you are no longer on the drug; however, Seroxat tapering has not been proven to prevent the symptoms of SSRI Discontinuation Syndrome.


Long-Term Effects of Paxil Use


Though most patients who experience SSRI Discontinuation Syndrome eventually get past their side effects, some patients who discontinue Seroxat and other SSRIs experience long-term effects. These include low-grade symptoms, such as persistent tinnitus or problems with concentration and memory, and more persistent and severe symptoms such as anxiety, sexual dysfunction, and others and may be present for the long-term.


While some patients have suffered from Seroxat side effects for as many as two years after withdrawal, others are suffering from SSRI Discontinuation Syndrome and its effects on an indefinite basis. However, the medical body of knowledge has not yet progressed far enough to be able to really assess or address SSRI Discontinuation Syndrome.


Suicidal Ideation: A Major Risk


SSRIs have notorious links to increased risks of suicide in patients, sometimes children, especially those withdrawing from the drug. Seroxat is not prescribed to patients under the age of 18; however, new warnings indicate that suicidal ideation is a risk in adults taking Seroxat, especially those between the ages of 18 and 30. Due to its continuing link with high risks of suicide and suicidal ideation, it is strongly recommended that patients who discontinue the use of Seroxat do so under controlled medical circumstances and with a doctor 's supervision.

**

http://www.mind.org.uk/Information/Seroxatwithdrawalinformation.htm


Withdrawal problems occur more commonly with paroxetine than with the other SSRIs. It is probable that these problems are associated with the fact that paroxetine has a short half-life, which means that it is metabolised and cleared from the body in a relatively short time. Withdrawal from drugs which have a long half-life (including Prozac) is naturally slower and more gradual than with those with a short half-life, and so causes fewer problems.



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

If Corporations were an individual

Dr Robert Hare: One of the questions that comes up periodically is to what extent could a corporation be considered to be psychopathic. And if we look at a corporation as a legal person, that it may not be that difficult to actually draw the transition between psychopathy in the individual to psychopathy in the corporation. We could go through the characteristics that define this disorder, one by one, to how they might apply to corporations. They would have all the characteristics, and, in fact, in many respects, the corporation of that sort is the proto-typical of a psychopath. (From the Documentary 'The Corporation')

Psychopath

Meaning #1:*someone with a sociopathic personality; a person with an antisocial personality disorder (`psychopath' was once widely used but has now been superseded by `sociopath')

Sociopath

*Someone whose social behavior is extremely abnormal. Sociopaths are interested only in their personal needs and desires, without concern for the effects of their behavior on others.

*Substitue the word 'Someone' to 'Corporation'

Does it remind you of any large corporation?

Here are some clues:

'Sociopaths are only interested in their personal needs and desires, without concern for the effects of their behaviour on others.'

'Sociopaths are only interested in their personal needs and desires, without concern for the effects of their behaviour on others' Part II

'Sociopaths are only interested in their personal needs and desires, without concern for the effects of their behaviour on others' Part III

See also -

GlaxoSmithKline, the Diabetes Drug Avandia and The Intimidation of Dr. John Buse

Glaxo, An Angry Blogger And Free Speech



Watch The Corporation.


HERE



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

Hurry up Dawn

It's one of those nights where I just cannot sleep. Time 3.09am as I write this. I've checked my mail, had the usual return from Google News Alerts, Paxil this, Seroxat that, GSK this, MHRA that. I've re-read emails sent to me during the day (yesterday), listened to the radio, a talk show about retro sweets. Aztec Bars, Mint Cracknell, Space Dust et al.

So here I am alone in my flat, save for my dog who is currently fast asleep on my bed... not a care in the world. The view from my flat is black at night, quite stunning in the day and simply divine as dusk breaks.

My thoughts go out to Shelly Hart and her family. Her husband, Gary, posted on her blog earlier that she was admitted to hospital because she was having life threatening withdrawal problems coming off Paxil. [Seroxat]

I remember my withdrawal hell like it were yesterday, in fact the blackness currently outside my window could be a painting of how I felt back then. The feeling of being totally alone, having nobody to turn to combined with the WHOOSH, WHOOSH, ZAP, ZAP head blasts caused by GlaxoSmithKline's wonder drug.

I used to sleep for England but since my three months of cold turkey some three years ago I haven't really had a decent sleep. It begs the question what the long term use of an antidepressant such as Seroxat is?

It's hard not to dwell on the past when one is left with such a scar as irregular sleep.

In truth I don't want to be here right now, my place reminds me of the hellish withdrawal. The fields that back on to my flat was where I used to walk during the early hours between the months of Feb & March. Uncontrollable zaps ripping through me, thoughts of harming myself... even worse harming others.

What has GlaxoSmithKline allowed to happen here? To market a drug that can have such an adverse effect on people is truly shameful. The consequences of withdrawal have had a devastating effect on my life. I am one of many thousands who have struggled at the hands of this drug. As I sit here typing there is some poor soul hospitalized because the sheer intensity of Seroxat withdrawal is too unbearable for them. Clinics up and down the UK... in fact all over the world, are treating people for SSRi addiction, an addiction that GlaxoSmithKline and other pharmaceutical companies along with the medicine regulators say does not exist.

It's a never ending nightmare and who knows if we will ever get any form of closure? Prosecutions would be nice. Someone MUST be held accountable for allowing this to happen... more importantly, allowing it to continue.

I'm think I will stay up to watch dawn break. A Dixie Chicks CD on in the background will be my company until then.

"And sometimes I don’t have the energy to prove everybody wrong and I try my best to be strong but you know it’s so hard, it’s so hard"

So Hard - Words & Music by Emily Robison, Martie Maguire, Natalie Maines, Dan Wilson

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

Tuesday, June 24, 2008

Musical Interlude - Inxs

My favourite Inxs track. The video was made by a fan. Job well done I think.

At times of sadness and regret I play this song to lift my spirits.

Michael Hutchence - Your spirit lives on.

Top man

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

Shelly Hart Hospitalized 'Life threatening withdrawal problems'

Shelly Hart, the writer of the PAXIL WITHDRAWAL HELL..THE BOOK IN PROGRESS blog was hospitalized yesterday due to her withdrawal problems. My thoughts go out to her,Gary, her husband and her children.

This is the second person I know [personally] who has been hospitalized due to withdrawal from an SSRi.

Shelly and Gary are currently in the process of writing a book about Seroxat withdrawal.

Keep strong. My thoughts are with you all.

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

COMMISSION ON HUMAN MEDICINES [FOI Request]

The Commission on Human Medicines (CHM) is a committee of the UK's Medicines and Healthcare products Regulatory Agency. It was formed in October 2005 by the amalgamation of the Medicines Commission and the Committee on Safety of Medicines.


The duties of the Commission which came into being on 30 October 2005, are set out in Section 3 of the Medicines Act 1968, as amended by the Medicines (Advisory Bodies) Regulations 2005 and include the following:


  • to advise Ministers on matters relating to human medicinal products (except those that fall under the remit of Advisory Board on the Registration of Homoeopathic Products (ABRH) and Herbal Medicines Advisory Committee (HMAC))

  • to advise the Licensing Authority (LA) where the LA has a duty to consult the Commission or where the LA chooses to consult the Commission including giving advice in relation to the safety, quality and efficacy of human medicinal products

  • to consider representations made in relation to the Commission’s advice (either in writing or at a hearing) by an applicant or by a licence or marketing authorisation holder

  • to promote the collection and investigation of information relating to adverse reactions for human medicines (except for those products that fall within the remit of ABRH or HMAC) for the purposes of enabling such advice to be given.

The Chair of the PATIENT INFORMATION EXPERT ADVISORY GROUP is Ms Joanne Rule.



Her DECLARED CURRENT PERSONAL AND NON- PERSONAL INTERESTS IN THE PHARMACEUTICAL INDUSTRY AS FOLLOWS:



3m Pharmaceuticals
Amgen Limited
Astrazeneca Plc
Baxter Healthcare Ltd
Bayer Plc
Bristol Myers
Cambridge Laboratories
Chiron UK Ltd
Eli Lilly & Co Ltd
Glaxo Smith Kline
Ipsen Ltd
Merck Pharmaceuticals
Napp
Novartis Pharmaceuticals
UK Ltd
Ortho Biotech
Pfizer Ltd
Pierre Fabre Ltd
Platon Medical
Roche Products Ltd
Sanofi Aventis
Schering Health
Schering Plough
Wyeth Laboratories



Q1. I would like to know what advice [if any] Ms Joanne Rule has given ministers regarding Seroxat?




Q2. I would like to know what advice [if any] Ms Joanne Rule has given to the Licensing Authority regarding the safety, quality and efficacy of Seroxat?



Q3. I would like to know if Ms Joanne Rule would be prepared to meet with a group of Seroxat campaigners/advocates/activists [call them what you will] at her earliest convenience?



Q4. I would like to know what Ms Joanne Rule has done to promote the collection and investigation of adverse reactions for Seroxat.




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, June 23, 2008

PAROXETINE

Rearrange the word Paroxetine and you will find a more apt name.

Axe Protein



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

Friday, June 20, 2008

Something of Interest for the FBI

Dear Sirs,

I give you one Martin B. Keller

The Life and Times of Martin B Keller, MD - Part I

The Life and Times of Martin B Keller, MD - Part II

The Life and Times of Martin B Keller, MD - Part III: Brown trousers

Journal Editor Unapologetic Over Paxil/Seroxat Article

Drs. Keller, Ryan & study 329…



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

FBI interested in how Study 329 was used to promote Paxil for teenagers and kids

It seems the shit has hit the fan, thanks in the main to Sen. Grassley.

Read Pharmalot's latest post - US Investigation Into Glaxo And Paxil Widens

The 2001 study has come under fire from several independent medical researchers. The prosecutor and FBI “were quite interested in how Study 329 was used to promote Paxil for teenagers and kids by clinical researchers Glaxo had underwritten,” Murgatroyd tells the paper.

Read all about it HERE





This video may guide the FBI to the truth.



See Also: FDA Got Left Out on Paxil Risk Documents

Litigation over GlaxoSmithKline’s handling of information about the suicide risk from antidepressant Paxil has turned up some documents that say a lot about why the FDA often seems to be in the dark when problems with drugs surface.... CONTINUES


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

Wednesday, June 18, 2008

Not so N.I.C.E

Have spent much of the past few hours reading through the N.I.C.E. guidelines on SSRi's. It prompted me to write an email to them. I must say some of the advice given is, at best, naive.

Is it any wonder that UK GP's are handing out SSRi's like candy!

Here is the email:


Dear Sir/Madam,

I have just downloaded a copy of CG23 Depression: Quick reference guide (amended) from the N.I.C.E. website ( http://www.nice.org.uk/guidance/index.jsp?action=download&o=29614) and as a former sufferer of Seroxat withdrawal would like to ask you a few questions. I have copied and pasted segments of the file and have followed each of them with a question. Please also find enclosed documents that should be of relevance to you when amending any future documents about SSRi's that you may offer healthcare workers in future.

I would like to add that SSRi withdrawal is a very serious problem and after reading your document I feel that N.I.C.E. are NOT taking this matter seriously.

My questions follow in blue text.

Yours sincerely

Bob Fiddaman

---

Prescription of an SSRI

• When an antidepressant is to be prescribed in routine care, it should be a selective serotonin reuptake inhibitor (SSRI), because SSRIs are as effective as tricyclic antidepressants and are less likely to be discontinued because of side effects.

Can you tell me why it took me 18 months to taper off Seroxat using the liquid suspension form? Please refer to attachment 1 and you will see horror story after horror story of patients who have had... and still are having severe problems tapering off Seroxat (Paxil in the States)

Tolerance and craving, and discontinuation/withdrawal symptoms

• All patients prescribed antidepressants should be informed that, although the drugs are not associated with tolerance and craving, discontinuation/withdrawal symptoms may occur on stopping, missing doses or, occasionally, on reducing the dose of the drug. These symptoms are usually mild and self-limiting but can occasionally be severe, particularly if the drug is stopped abruptly.

I would like for N.I.C.E. to consider amending the above paragraph. Firstly, one craves the drug when its effects wear off, this is not as a result of the illness, it is a result of the side effects. In layman's terms, the intake of serotonin wears off and the patient may get zaps, cold sweats etc, therefore they crave more. Could you also consider changing the last line of the above para? Please stress the point that these types of drugs SHOULD NOT be stopped abruptly and also add to the word 'severe' - tell patients and healthcare specialists exactly what you mean by severe. Would this be possible?

Maintenance treatment with antidepressants

• Patients who have had two or more depressive episodes in the recent past, and who have experienced significant functional impairment during the episodes, should be advised to continue antidepressants for 2 years.

What are the implications of long term use of SSRi's? Has there ever been any scientific study that shows it is safe to continue taking SSRi's after a two year period? Could N.I.C.E. show me this evidence?

Where mild depression persists after other interventions, or is associated with psychosocial and medical problems, consider use of an antidepressant.

Has N.I.C.E. not taken the recent study by a University of Hull team that concluded the drugs actively help only a small group of the most severely depressed into account? Why would N.I.C.E. state that mild depression be treated with an SSRi when it has been proven that an SSRi will be about as effective as a placebo for this level of depression?

Treatment of moderate to severe depression in primary care

Starting treatment

• In moderate depression, offer antidepressant medication to all patients routinely, before psychological interventions.

Once again, I refer you to the recent study that indicates that SSRi's do not work in mild to moderate depression. Once again I have to ask N.I.C.E. why they are advising the use of SSRi's in moderate depression?

Discuss the patient’s fears of addiction or other concerns about medication. For example, explain that craving and tolerance do not occur.

As I pointed out earlier and as you will see from attachment 1 - Craving and tolerance DO occur. I suggest to N.I.C.E. that Seroxat in particular IS an addictive drug.


When starting treatment, tell patients about:

– the risk of discontinuation/withdrawal symptoms
– potential side effects.

Could N.I.C.E. elaborate on ALL side-effects reported and please list them in any future files they may offer healthcare specialists? See attachment 1 for a rough guide to some of the more 'aggressive' reactions to Seroxat.


Inform patients about the delay in onset of effect, the time course of treatment and the need to take medication as prescribed. Make available written information appropriate to the patient’s needs.

Also warn patients of ALL ages about the possible risk of suicide/suicide ideation - see attachment 2 (Glenmullen Report)


Monitoring risk

• See patients who are considered to be at increased risk of suicide or who are younger than 30 years old 1 week after starting treatment. Monitor frequently until the risk is no longer significant.

If a patient is 31, 32, 33 et al are they not to be considered at an increased risk of suicide? Once again I refer you to attachment 2 (Glenmullen Report)

If there is a high risk of suicide, prescribe a limited quantity of antidepressants.

If a patient feels suicidal when tapering from SSRi's what advice would N.I.C.E. give?

Monitor for signs of akathisia, suicidal ideas, and increased anxiety and agitation, particularly in the early stages of treatment with an SSRI.

Would N.I.C.E. consider changing the above to 'IN ALL stages of treatment with an SSRi' rather than 'in the early stages of treatment with an SSRi'?

Advise patients of the risk of these symptoms, and that they should seek help promptly if these are at all distressing.

Can N.I.C.E. elaborate to healthcare specialists exactly what they mean by 'distressing'?

If a patient develops marked and/or prolonged akathisia or agitation while taking an antidepressant, review the use of the drug.

What are the guidelines when reviewing the use of an SSRi?


Continuing treatment

For patients with a moderate or severe depressive episode, continue antidepressants for at least 6 months after remission.

Why?

Once a patient has taken antidepressants for 6 months after remission, review the need for continued antidepressant treatment. This review may include consideration of the number of previous episodes, presence of residual symptoms, and concurrent psychosocial difficulties.

Could N.I.C.E. also add to the above para 'A patient maybe experiencing serotonin withdrawal, this should not be confused with a depressive illness'

Choice of antidepressants

• For routine care, use an SSRI because they are as effective as tricyclic antidepressants and less likely to be discontinued because of side effects.

Please refer to attachment 1

If increased agitation develops early in treatment with an SSRI, provide appropriate information and, if the patient prefers, either change to a different antidepressant or consider a brief period of concomitant treatment with a benzodiazepine followed by a clinical review within 2 weeks.

Seroxat discontinuation should be administered by use of the oral suspension form and an oral syringe. One CANNOT taper slowly off a tablet unless they suck it for a few minutes, leave it on the side then suck it again the next day!


Stopping or reducing antidepressants

• Inform patients about the possibility of discontinuation/withdrawal symptoms on stopping or missing doses or reducing the dose. These symptoms are usually mild and self-limiting but can occasionally be severe, particularly if the drug is stopped abruptly.

Once again, the word 'severe' is merely glossed over. Could N.I.C.E. explain what the severe symptoms are?

Reduce doses gradually over a 4-week period; some people may require longer periods, and fluoxetine can usually be stopped over a shorter period.

On a personal level it took me 18 months to taper down from 40mg of Seroxat to 22mg of Seroxat. Would N.I.C.E. consider dropping the 4 week period statement. Please refer to attachment 1 to see exactly how many patients have taken months and in some cases years to taper from Seroxat.

For severe symptoms, consider reintroducing the original antidepressant at the effective dose (or another antidepressant with a longer half-life from the same class) and reduce gradually while monitoring symptoms.

So N.I.C.E. are suggesting if someone is having difficulty tapering from an SSRi the GP should reintroduce the SSRi at the effective dose? How then does the patient withdraw?

Ask patients to seek advice from their medical practitioner if they experience significant discontinuation/withdrawal symptoms.

What advice have N.I.C.E. given to medical practitioners for patients experiencing significant withdrawal problems?


I look forward to your response.

As a matter of public interest I will republish this email in its entirety on my blog 'Seroxat Sufferers'

Bob Fiddaman

http://fiddaman.blogspot.com/

cc Janice Simmons Seroxat User Group

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

Parents blame Glaxo toothpaste for allergy death

News you may have missed. This from January 2008

Source: Daily Mail

A teenager died after suffering an extreme allergic reaction to toothpaste, her family said yesterday.



In the days before her death Francesca Sanna, 19, had complained her gums were sore.



She collapsed and died from anaphylactic shock minutes after brushing her teeth while preparing for a night out with friends, an inquest was told.



Francesca - known affectionately as Mim - suffered from asthma and severe allergies which dogged her life.



Her parents believed the newly repackaged Aquafresh toothpaste was the most likely cause of the fatal reaction.
But the inquest in Blackburn was inconclusive.



Pathologist Dr Richard Prescott told the hearing toothpaste could cause sever reactions.

Commenting on the post mortem findings, he said: "Both lungs were inflamed and the bronchials were plugged with mucus, but she did not die from an asthma attack."



"It could have been a number of different things. People have suffered severe reactions in the past from toothpaste, mouthwash or even tampons."



Coroner Carolyn Singleton recorded a narrative verdict and concluded Francesca died from an acute anaphylactic reaction and asthma.



She said: "She must have come into contact with or ingested something that caused her death. She was a young lady who was very careful, she knew what she could and could not touch."



Francesca's parents think she suffered a reaction to a newly opened tube of Aquafresh

"The cause of the reaction might have been new to her. It is possible to develop allergies to stuff that you have never been allergic to."



Francesca, of Oswaldtwistle, Lancashire, was in a car with friends heading for a night out in October when she suddenly lurched forward and went white. She was taken home, where she collapsed in the hall.

Her parents raced back from the family's Italian restaurant and a nurse, who happened to be nearby, tried in vain to revive her.



After the inquest Francesca's mother Kim warned allergy sufferers and manufacturers to take care to prevent future tragedies. She said the family believed the toothpaste was linked to her death.



Mrs Sanna said: "I think that further tests have to be done to determine what happened to Francesca, but I am happy with the results from the inquest."



"From the beginning I thought that toothpaste might have contributed to her death. We always used Aquafresh Mild and Minty and then the packaging changed."



"This is when Francesca started to complain of sore teeth and gums a couple of weeks before she died."



"We looked in her mouth but it looked fine, we were used to the classic symptoms of anaphylaxia."



"Her reaction was so severe and so quick the trigger must have been something she did before she left the house, like brushing her teeth."



"I want people to take allergies more seriously, almost from birth she suffered from allergies. But on this occasion she didn't have the usual warning signs."

A spokesman for GlaxoSmithKline, the manufacturers of Aquafresh, said despite the newlook packaging the product had not changed since 2001.



She said: "Although we have not yet had an opportunity to see the coroner's report, we understand that no conclusion was made as to the cause of the anaphylactic shock."



"We receive less than a handful of complaints of allergic reaction to Aquafresh Mild and Minty each year, all of which have been of a mild and localised nature."



"To put this in context, over 1.9million tubes are used by consumers in the UK every year."



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

PMT? - Try Seroxat!

It seems The National Association for Premenstrual Syndrome (NAPS) says more and more women are contacting them because they reckon they've wrongly been prescribed anti-depressants including Prozac and Seroxat.

As a man, I cannot begin to imagine the changes in a woman as she goes through her premenstrual cycle. For sure, I've witnessed it and have never really quite understood the mood changes in a woman during that particular 'time of the month'.

One thing I do know however is by giving Seroxat to a patient because they are going through what every single woman on this planet goes through is ludicrous.

Once again, GP's are prescribing antidepressants for something other than severe depression.

Why not just give the patient a gun!

The MHRA should contact NAPS and offer some advice. They should also send out a 'Dear Doctor' letter to every GP in the UK advising them that drugs such as Seroxat should not be given to women with period problems.

I think we have more chance of Hell freezing over before Kent Woods and his posse act upon this.

Read 'Drug warning for PMT sufferers' from Radio 1's Newsbeat here


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

Tuesday, June 17, 2008

Paxil on Trial - New book set to kick where it hurts.


Pharmalot has interviewed Alison Bass, the author of a new book 'Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial' (Now in stock on Amazon)


It's a great interview and I suggest you all read it. I will purchase a copy of the book by the end of this month. No doubt it will state what we already know but it just highlights how people have had enough of GlaxoSmithKline and Paxil.


Alison's blog can be read here



I'll reproduce Pharmalot's interview here but urge you all to nip over to Pharmalot to leave your comments (HERE)


From Pharmalot...



Perhaps no other drug over the past several years epitomized the controversy over antidepressants and suicidal side effects than Glaxo’s Paxil. The drug has become a sort of poster child for the debate over hidden clinical data, ghostwriting and failed FDA oversight. As a reporter at The Boston Globe during the 1990’s, Alison Bass began delving into pieces of the tale and returned to the topic several years later to write a fact-filled, yet breezy book that is being published this week: ‘Side Effects: A Best-Selling Drug on Trial.’ We chatted with Alison about the Paxil scandal…





Pharmalot: What prompted you to write the book?



Bass: When I heard about the New York Attorney General’s investigation, which was in 2004, I realized a source of mine had told me about Brown University and Martin Keller, a professor who ran Paxil studies, and how the studies were coded incorrectly. At the time (the source conveyed this information), I didn’t understand the significance, but then the investigation began. And I realized there was a very interesting and important story to tell. It was eye opening.



Pharmalot: There have been many troubled drugs, though. Why tell this story?



Bass: They’re all worth telling. I’m not saying this one is more important than another. I happened to have written about some of this while at the Globe. But I wanted to tell a story about people whose lives were affected by the extent to which some companies would go to boost sales of their products. Most people have no idea about the connections between some doctors and drug companies. This is largely out of sight and there’s very little oversight, in fact, of these sorts of things. And I believe there’s a need for reform, but the FDA still isn’t doing its job.



Pharmalot: What would you say is different about the Paxil tale?



Bass: Well, to some extent, it’s the people. Take Marty Teicher (a researcher at McLean Hospital), who was the first to speak out against Prozac. Here was someone who tried to make a difference and speak his mind, and he saw his reputation smeared. He was the first psychiatrist and researcher to publish findings of an increase in suicidal risk in Prozac. And most psychiatrists at the time thought Prozac was a magic bullet and a great improvement over older antidepressants. All he wanted to do was alert doctors to side effects in some people and that’s precisely what drugmakers didn’t want him to do.



And there was Rose Firestein, who’s legally blind. Because of her work for Children’s Rights (a nonprofit that works on behalf of foster children) and the way she saw drugs used in a vulnerable population, when she got to the New York Attorney General, she had a unique perspective and wanted to look at off-label use. But she came up with novel idea of using the New York State consumer fraud statute to go after drug companies. No one had ever done that before. And she had the goods and the evidence. So they were such interesting people who were involved in all this and they believed in a greater good.



But this is just one example of a bigger problem that has continued in a long line through Vioxx and Vytorin. Drug companies know the side-effect profiles of their drugs and hide something. In the case of antidepressants, these drugs do a lot of good for a lot of people, but for a small population, doctors didn’t know these drugs had (suicidal) side effects and, as a result, didn’t monitor patients as closely as they should have. But they didn’t have the information, because Glaxo didn’t publish its negative findings.



Pharmalot: What was the most surprising info you came across while researching the book?



Bass: What I found most surprising was they doctored the research on the Paxil study. When I looked back at memos I received from the Institutional Review Board from Brown, teenagers were withdrawn from the study and called non-complaint when they were in suicidal as a result from Paxil and should’ve been counted in the study as adverse effects. If these had been appropriately coded, there would have been an even greater risk of suicidal effects from Paxil. That was really amazing. There were many indications this Paxil study, it was called study 329, was doctored. But because it was published in a prestigious medical journal, Journal of the American Academy of Child & Adolescent Psychiatry in 2001, doctors paid attention.



Pharmalot: In reading the book, you don’t get much of Glaxo’s voice. Did the company not cooperate?



Bass: They didn’t respond to my requests. I spoke with Wick (Joseph Sollers, an attorney with King & Spalding, which represented Glaxo) on the phone a few times. I asked if I could interview some of their top officials, but they wouldn’t grant the requests. I did speak with the spokeswoman several times, as you could tell. But there were a lot of unseen documents from lawsuits. That’s how I got the smoking gun memo saying not to publish negative studies.



Pharmalot: What lesson can be learned from all this?



Bass: A few things. There has to be full disclosure of clinical trial data. And doctors have to acknowledge when they have conflicts of interest. Major academic centers should have requirements that doctors aren’t allowed to earn more than ‘X’ amount from a drug company. As I wrote in my blog recently, Marty Keller, the principal Paxil investigator at Brown University for the 329 study, acknowledged receiving consulting fees from Glaxo, but never reported them on his tax return. Researchers who are getting lucrative personal payments should be prohibited from studying these drugs if they’re making more than whatever minimum is established by the institution. But you know, these studies are a great source of income for these institutions.



Pharmalot: Have industry practices not changed since the Paxil scandal? That was a few years ago already, yes?



Bass: They’re still paying lucrative payments to doctors and researchers, and still misleading patients by not telling the full story about the risks, whether it’s in the advertising or the medical journals. The practices are still going on. Some companies are more ethical than others, but the business model is to develop blockbuster drugs. And the people in charge are marketers, not scientists. Which brings us to the FDA, which I don’t think has provided suffiicent oversight. Again, the drugs can help some people, but hurt others, and the oversight hasn’t been working.




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

Wall Street Journal Talk

Well it seems to be kicking off with Sen. Grassley, the FDA and GlaxoSmithKline over in the States. Where our own regulator failed perhaps the United States regulator [FDA] will carry a thorough investigation and prosecute those responsible.

I'm fed up of the EU Law bullshit the MHRA have used as an excuse not to prosecute. I'm fed up of GlaxoSmithKline spokespersons [Including Garnier] claiming they have done nothing wrong - when they clearly have!

The upshot is Glenmullen found there was an 8 fold increase in suicide when taking Seroxat and Glaxo played this down with 'dirty' numbers.

I had a conversation with a reporter from the Wall Street Journal earlier, they was of the opinion that the MHRA had come down hard on GlaxoSmithKline. I have to disagree. Personally, they have basically clipped them around the ear and told them in future they can't manipulate results.

We are talking about human life here! This is not a speeding offence and a cop who is on his way home and can't be bothered to do the paperwork.

THEY DID WRONG and our regulator wrote them a letter!

They mass produced a tablet for the masses and they KNEW there was an 8 fold increase in suicide for anyone taking it... and they said nothing!

We can point the finger at individuals - the likes of Martin Keller, Alistair Benbow even Garnier but without those arrests the MHRA failed to make we are more or less back to square one - We are at the start of the MHRA's four year investigation again.

End of the day our own regulator wrapped the Glaxo suspects up in cotton wool and treated them with kid gloves mainly because mud sticks.

Hopefully Sen. Grassley will kick some 'ass' and demand answers from the FDA - answers that our own regulator [MHRA] have failed to supply us (for whatever perverse reason)

Sen. Grassly has my backing on this - as do the Wall Street Journal for reporting it. I will do everything in my power to guide them to various places around the Internet where documents have been in the public domain for many years.

Alas, I will not hold my breath as the FDA seems about as useful as a chocolate teapot... pretty much like our own regulator.

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

More on GSK hiding data

Source: THE WALL STREET JOURNAL

Unsealed Report Claims Suicide Risk Was Miscalculated

By ALICIA MUNDY and JEANNE WHALEN

GlaxoSmithKline PLC faces new questions about whether it deliberately misrepresented data on suicide risk for its antidepressant Paxil when it applied for the drug's approval to the U.S. Food and Drug Administration at an advisory committee meeting in 1991, a charge the company has denied.

A study by a Harvard psychiatry instructor, underwritten by plaintiffs' lawyers and previously kept under seal by a court order, says that Glaxo "improperly" counted patients taking placebos during clinical studies. From 1989 through 1991, Glaxo then submitted information to the FDA that indicated no major difference in risk of suicidal behavior, or suicidality, as doctors call it, between patients who took Paxil and those who took a placebo.

However, Glaxo's counting minimized the differences between suicidality rates in the Paxil and placebo groups, according to the report. For instance, the company counted placebo patients who had attempted or committed suicide before the study formally started, which enhanced the results for Paxil.

The real risk for suicidality from Paxil, says the report's author, Joseph Glenmullen, was eight times its risk for patients on placebo. "Glaxo was aware of this risk, and hid it," Dr. Glenmullen's report states. The drug was approved for sale in the U.S. in 1992. Dr. Glenmullen said, in an interview Thursday, that if Glaxo had given the agency the "correct" data in 1991, the FDA would likely have added warnings about the risk for suicidality when it approved Paxil.

In 2004, the FDA called for added warnings on popular antidepressants known as selective serotonin-reuptake inhibitors, or SSRIs, about potential links to suicidal behavior. In 2006, Glaxo sent a letter to doctors stating that its studies showed that the risk of suicidality in depressed adults was 6.7 times as high in patients taking Paxil as in those taking a placebo.

Thursday, Sen. Chuck Grassley, an Iowa Republican, released Dr. Glenmullen's study and a letter to the FDA, asking it to investigate the original approval process for Paxil and Glaxo's application in light of Dr. Glenmullen's report.

A Glaxo spokeswoman emailed a company statement that was originally issued Feb. 6, when an earlier version of Dr. Glenmullen's report was first unsealed by a court. That version was missing nine pages that included information on Glaxo's counting methods.

"GlaxoSmithKline has provided the U.S. Food and Drug Administration over the years with numerous reports from its clinical studies," the statement says. "As soon as GlaxoSmithKline became aware of a potential increased risk in certain populations, it proactively brought it to the attention of FDA and other regulatory bodies."

The statement notes that Dr. Glenmullen was hired by plaintiffs' lawyers, and calls his report "unscientific and misleading."

Sen. Grassley also raised concerns about a British investigation that concluded this year that Glaxo should have alerted British regulators earlier than it did about a link between Paxil and suicidal behavior. He said evidence in the two reports raises questions about whether the company kept U.S., as well as British health officials, in the dark.

In March, British authorities concluded a four-year investigation on whether Glaxo failed to inform the U.K. drug regulator in a timely manner about a link between Paxil and suicidality in children and teens. They said they saw no basis for criminal prosecution of Glaxo because U.K. laws were unclear about whether companies were obligated to report certain drug data. But the regulator said it remained "concerned that GSK could and should have reported this information earlier than they did."

Glaxo at the time said: "We firmly believe we acted properly and responsibly."

Paxil was made by SmithKline Beecham, which merged with Glaxo Wellcome in 2000. SmithKline's former top executive, Jean-Pierre Garnier, who was Glaxo's CEO until last month, said in a 2006 deposition in a lawsuit that the original data given to the FDA shouldn't have included some of the placebo patients. In another 2006 court document, Glaxo "admits that five of six 'attempted suicide' events" in the placebo group took place before the studies began.

During the 1991 meeting, members of the FDA's advisory committee repeatedly said they wished there were more data to review on suicidality, but, the report said, "unbeknownst to the committee, the data already existed."

Write to Alicia Mundy at alicia.mundy@wsj.com and Jeanne Whalen at jeanne.whalen@wsj.com

Sen. Grassley's letter to the FDA and the Glenmullen Report on Paxil

...
...
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, June 16, 2008

Washout Or Whiteout? Paxil And Placebo Suicides

If the Ford Motor Company hid a defect in its product they would be hauled over the coals and sued by everyone and anyone who had ever had the misfortune to crash in one of their cars.

Why not Glaxo?

Unless of course, a ‘Don’t be naughty again’ type of letter sent to their CEO from the MHRA is that ‘hauling over the coals’?

Anyone with a decent amount of common sense here can see that they deliberately marketed a drug knowing that the suicide rate was abnormally high. This is not about ethics, surely this is about manslaughter?

If only the law were as simple huh?

Instead it takes years of legal wrangling between lawyers that ultimately ends up in a settlement with gagging orders placed on those who have endured unforeseen side effects from a drug that should never have been granted a license.

The company, in this case, GlaxoSmithKline offer a compensation payout - compensation that is in essence money they have earned from the sales of a defective drug. Money that could have… would have been better spent manufacturing a pill that actually carried no threat for the patient.

And still this drug is prescribed!

This from Pharmalot's Ed Silverman

Washout Or Wipeout? Paxil And Placebo Suicides

By Ed Silverman // June 16th, 2008

Last week, US Senator Chuck Grassley called for a probe into Glaxo and the FDA over their handling of the Paxil antidepressant. At issue are the long-standing allegations that the drugmaker knew about suicide risks in children for nearly 15 years but obscured evidence.

In demanding the probe, Grassley cited a report prepared by Joseph Glenmullen, a Harvard psychiatry professor, for litigation in federal court in California over Paxil side effects. The report was unsealed earlier this year, but was missing some pages. Last week, those pages became available and include a section that describes in some detail how Glaxo allegedly manipulated so-called placebo suicides.

These are deaths that occur among patients who are taken off other meds so they can participate in a trial. “The rationale from washing out all drugs is to prevent them from confounding the results of the study, so that all patients start out the study in similar conditions,” according to the Glenmullen report, which goes on to maintain Glaxo “improperly” minimized the differences between Paxil and placebo suicide data in order to obtain favorable results.

As a result, the actual suicide risk was eight times its risk for patients on placebo. “Glaxo was aware of this risk, and hid it,” the report states, as The Wall Street Journal noted over the weekend in a story that refers to the previously missing pages. Here is the full report and page 47 offers a summary of Glaxo’s efforts.

Related Links:

Glaxo Obscured Paxil Suicide Risks: Report
Grassley Probes Paxil Suicide Risks
Glaxo Escapes Prosecution Over Paxil In UK
What Negative Data? Paxil & Selective Reporting
...
...
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

Sunday, June 15, 2008

Dear Mr. Woods CEO of the MHRA...

----- Original Message -----
From: fiddaman
To: KENT WOODS
Cc: JOHN WATKINS
Sent: Sunday, June 15, 2008 6:20 PM
Subject: Paxil [Seroxat] Liability Report

Dear Mr. Woods,

Please find
attached something that has been in the public domain for over 2 years. I suggest you read it and amend the PIL for Seroxat immediately.

As usual I have blind copied in the main Seroxat 'voices'

Regards

Bob Fiddaman




Related Links:

Paxil Special Report I--"Court Filing Makes Public My Previously Suppressed Analysis of Paxil's Effects." Ethical Human Psychology and Psychiatry, 8, 77-84, 2006.

Paxil Special Report II--"How GlaxoSmithKline Suppressed Data on Paxil-Induced Akathisia: Implications for Suicidality and Violence", Ethical Human Psychology and Psychiatry, 8, 91-100, 2006.

Paxil Special Report III--"Drug Company Suppressed Data on Paroxetine-Induced Stimulation: Implications for Violence and Suicide", Ethical Human Psychology and Psychiatry, 8, 255-263, 2006.

"Suicidality, Violence and Mania Caused by Selective Serotonin Reuptake Inhibitors (SSRIs): A Review and Analysis." International Journal of Risk and Safety in Medicine, 16: 31-49, 2003/2004. Originally published in Ethical Human Sciences and Services, 5:225-246.

Source: http://www.breggin.com/

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

The FDA Wants to Stop You from Protecting Yourself Against Drug Companies

"But the federal agency continues to serve drug company interests by limiting the risk to children, youth and young adults. That's simply nonsense."



Source: The Huffington Post

Suing a drug company is your only way as an individual citizen of protecting yourself again drug company malfeasance. It's the only way for you or your survivors to get justice or compensation if you have been injured or killed by drug company negligence. It should be a basic right under the law, and right now it is; but the FDA and the drug companies are on the verge of taking it away from you.

Without the right to sue pharmaceutical companies, not only will individuals fail to obtain justice, sealed company data about the harmful effects of drug will remain secret. That can become a public health problem when serious adverse reactions are hidden from view. The Wall Street Journal has released data indicating that GlaxoSmithKline (GSK) may have manipulated research in order to hide that its antidepressant Paxil was causing people to attempt suicide. In the weekend edition of June 14-15, 2008, the newspaper described how the drug manipulated its figure to disguise the frequency of Paxil-induced suicide attempts.

I had known for years about GSK manipulating its data and had attempted without success to get the FDA to acknowledge and to examine the problem. I originally discovered the shenanigans eight years ago when I was examining the secret files of GlaxoSmithKline (GSK) as a medical expert in a product liability suit against the company. California attorney Don Farber and my assistant Ian Goddard accompanied me.

The suit was brought by the family of a man named Lacuzong who had drowned himself and his two young children in a bathtub a few days after starting to take Paxil. He had no previous history of violence or suicidal thoughts.

As I went through the hundreds of boxes of materials packed into a large room in the GSK company headquarters, I came upon something remarkable. GSK had managed to hide that Paxil was causing an increased rate of suicide attempts compared to placebo. The company jacked up the number of suicide attempts in the placebo group, until it looked more dangerous to take placebo than to take Paxil. In reality, there were more suicide attempts among the patients taking Paxil.

I wrote a lengthy report charging the company with negligence in the development and marketing of Paxil and it was submitted to the court in 2001. Despite attorney Don Farber's best attempts, the court refused to unseal the data, even though it disclosed a public health threat of suicidal behavior induced by an antidepressant drug that was being prescribed to millions of unsuspecting citizens. The case was settled for a substantial amount of money without GSK admitting any negligence, and the smoking-gun files were kept secret. Nonetheless, I wrote about my findings and even told the FDA about the manipulated data when I addressed the agency's panel on two occasions at its 2004 hearings on antidepressant-induced suicide. I invited the FDA to make use of my knowledge about how GSK was fudging its research findings, but the agency ignored my offer and my written reports. This was not unusual. The FDA has always failed to utilize the otherwise unavailable information gathered by medical experts, and yet it will not carry out its own investigations.

A few years later I participated along with attorney Farber in another product liability suit against Paxil and GSK involving suicide. Again the case was settled to the satisfaction of the plaintiffs without GSK admitting any wrongdoing. But this time the new court made public my original Lacuzong report. As a result, in 2006 I was able to write three articles about my findings in the scientific journal, Ethical Human Psychology and Psychiatry, and I put the articles along with the original Lacuzong product liability report on my website, www.breggin.com where they can still be found. The report and the articles describe many ways in which GSK managed to hide the truth that Paxil increases the risk of a person attempting suicide. This is the same information now released by TheWall Street Journal as a result of yet another expert's product liability case report that drew in part upon my original data.

To this day, the FDA continues to act as if drug company data can be trusted, including GSK's invalid manipulation of the Paxil suicide studies. The FDA has also ignored data that I discovered in product liability suits against Prozac and Eli Lilly. Eli Before Prozac went on the market, Lilly knew that patients taking their drug had a hugely increased rate of suicide attempts compared to similar or the same patients taking placebo. Even after the British medical journal BMJ released this data, the FDA has continued to ignore it.

In the meanwhile, I've continued to write about how GSK and Lilly have shamelessly distorted their research findings, and about how Paxil and Prozac cause mayhem, murder and suicide. The most vivid details involving dozens of cases can be found in my new book, Medication Madness: A Psychiatrist Exposes the Dangers of Mood-Altering Medications (2008).

Despite the flawed data, the FDA has finally warned that antidepressants like Paxil and Prozac (indeed, all of the newer antidepressants) cause suicidality. But the federal agency continues to serve drug company interests by limiting the risk to children, youth and young adults. That's simply nonsense. There can be no parsing of the data in that manner. If a drug-induced suicide risk shows up in short-term, heavily manipulated clinical trials, it's a serious signal that the drug will be a risk to a person of any age. And besides, the data itself is too flawed to make fine distinctions such as the age of the person at risk.

All of this critical information about drug safety, or the lack thereof, has come from product liability suits in which the courts have forced the drug companies to allow medical experts into their files to carry out an independent investigation. This November the U. S. Supreme Court will consider whether or not these suits should be permitted to continue. The drug companies and the FDA have joined together to argue that, once the FDA approves a drug, the manufacturer cannot be sued for its failures to disclose dangerous drug effects. This is called preemption. It should be called a political sleight of hand. It deprives the individual of his or her legal recourse, prevents physicians and scientists from learning the truth about harmful drug effects, and exposes the unwitting public to harm of potentially epidemic proportions.

Certainly drug companies have done a great deal to improve the health of people around the world. But they also have a bad record for hiding harmful and even lethal side effects of their products. If the Supreme Court supports preemption and hampers or stops product liability suits, it will be a bad day for people who use prescription drugs or prescription devices. That's pretty much all of us. Everybody's health will be put at risk when drug companies can no longer be monitored and scrutinized by product liability litigation.

Dr. Peter Breggin

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

Friday, June 13, 2008

The NHS on antidepressants

Quite laughable and contradictory if you ask me.

Information from NHS Foundation Trust

The page is entitled 'How SSRIs (probably) work'

Probably?

Straight away I have a tendency to take the information given with a pinch of salt.

The NHS giving information on how SSRi's probably work?

It's a bit like a car dealer telling you that the car you are about to buy will probably get you from A to B and you probably will be safe despite the engine not being thoroughly tested. Oh, and you will probably be safe wearing a seat belt with this particular model sir because it's probably passed all the test regulations!

How can the NHS get away with such vagueness? How have the MHRA got away with it for years? How have GlaxoSmithKline got away with it regarding Seroxat?

I'm sitting here with a wry smile on my face - there is nothing more left to do than to smile at the hypocrisy of it all.

The NHS site How SSRi's (probably) work kicks off with a marvellous piece of patronization.

It states:

In order to try to understand a little about how drugs work, it is best to first learn a few facts about the brain. Each human being has:

One head

One brain

Thanks for clearing that up - What would we do without you?

They then go on to explain to the layman (or the paupers) about brain cells and nerve fibres. They then tell us that... and I quote, 'the brain is an extraordinarily complex part of the body.'

Really?

Who needs to study a beginners course in psychology when we have the wisdom of the NHS!!!

Next up for us mere mortals is an explanation of synapses.

They state:

Synapses are very important because;-

There are a lot of them

Thank you oh wise ones. I sit in utter disbelief at your confound wisdom.

They then tell us what happens when a brain cell decides to send a message to another cell in order to make something happen.

This is all highly educational. There's talk of transmitters, electrical impulses, nerve fibres, and receptors.

Then our good friend Serotonin or 5-HT makes an appearance.

The NHS explain:

In the body, 5-HT is involved with blood pressure and gut control.
In the brain, it controls mood, emotions, sleep/wake, feeding, temperature regulation, etc.


More so they tell us what happens if problems get out of balance:

Too much serotonin and you feel sick, less hungry, get headaches or migraines
Too little and you feel depressed, drowsy etc.


Hmmm

In 2007 the MHRA told us “A variety of factors can contribute to an individual’s predisposition to depression. Although it is believed that depression may be caused by a biochemical imbalance and it is recognised that serotonin plays a role in the development of depression it is considered that there is more than one final common pathway in the aetiology of depression, and we are not aware of an internationally agreed ’proper chemical balance of serotonin in the brain’ that would prevent or reduce the likelihood of experiencing depression."

They added

"As the precise role that serotonin plays in depression is still subject to ongoing research we really are not best placed to provide you with a response on this particular issue.”

Hang on - The NHS say:

Too much serotonin and you feel sick, less hungry, get headaches or migraines
Too little and you feel depressed, drowsy etc.


Whilst the MHRA state:

"As the precise role that serotonin plays in depression is still subject to ongoing research we really are not best placed to provide you with a response on this particular issue.”

So what about GlaxoSmithKline? What exactly is their take on the whole serotonin issue?

In 1997 the patient information leaflet [PIL] that accompanied Seroxat told us that Seroxat:

"...boosts the levels of serotonin in your brain and that’s what makes you stop feeling depressed"

9 years later, GlaxoSmithKline had moved the goalposts. The patient information leaflet read:

"...It is not fully understood how Seroxat and other SSRIs work…"

Even more confusing is GlaxoSmithKline's Australian web page. It's now 2008 and they tell us:

"Aropax [Seroxat] corrects the chemical imbalance and so helps relieve the symptoms of depression."

Back to the NHS - Here they explain depression:

"In depression, it is known that there are reduced levels of serotonin and noradrenaline. These reduced levels lead to a lowering of mood. The full reasons are not fully known but stress may well play a part in causing this."

It is known that there are reduced levels of serotonin? The full reasons are not fully known...?

Thanks. That's clear as day!

Section 6 of the NHS page is entitled:

'HOW SSRI ANTIDEPRESSANTS PROBABLY WORK'

*Coughs*

Don't you just love the way they cover themselves [Probably]?

Face it. The NHS, the MHRA and GSK have not got a clue how this drug works, more importantly they went into this with eyes shut firmly and when the brown stuff hit the fan their eyes remained shut. People have died as a result of their probabilities, people have...and still are suffering because they cannot decide how the hell a drug works.

This is like some recurring nightmare. I may buy myself a chemistry set and manufacture a pill. I will tell the MHRA that it corrects the chemical imbalance of the brain - I'm sure it will get a licence, though Ian Hudson may be a stumbling block as he is head of licensing at the MHRA - he used to work at GSK [then SKB] and may see my new pill as a threat to his former employees miracle pill.

Hey, if it gets passed by the MHRA and later down the line I claim that it is not known whether or not it actually corrects the imbalance of serotonin then I'll still be sitting pretty. The MHRA won't remove it from the shelves even though I was adamant that it corrected the imbalance when I first told them but now I wasn't so sure?

Section 8 of the NHS page - 'DO THE SSRIs WORK, AND FOR HOW LONG?'

"We do not know for certain what happens after five years. Many people may be advised to carry on with an antidepressant for longer but that is a decision for you and your doctor to make."

Gee thanks. Talk about washing your hands of a problem!

Personally, I was on Seroxat for 6 years and now I read 'We do not know for certain what happens after five years'

So where does that leave me?

I have short term memory problems and an undesirable sleep problem - both of which I never had before taking Seroxat. I take it that the NHS don't know why I have this problem? Would they lean toward prolonged use of Seroxat? I think a court of law would don't you?

What kind of half assed system are we under here?

We have the NHS giving out messages contradicted by the MHRA who in turn are contradicted by GlaxoSmithKline!

It's an utter farce. A health system giving out information that is not scientific fact, a medicines regulator ignoring the problem of SSRi withdrawal and a manufacturer being allowed to do as it pleases. What a nightmare!

The Health Minister role in the UK changes like the wind - I have no idea who the current one is. Whoever it is I hope you sleep well.

The CEO of the MHRA is Kent Woods. I hope he sleeps well.

The CEO of GlaxoSmithKline is Andrew Witty. I hear rumours that on taking over his new role he turned to Garnier and said 'That's another fine mess you've got me into' - I hope he sleeps well.

I'd be embarrassed to show my face to any of my friends or family if I were any of the above.

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

Glaxo shares lower as Grassley asks for FDA Paxil review

LONDON (MarketWatch) -- GlaxoSmithKline (GSK)


UK:GSK 1,061.50, -12.50, -1.2%) shares slipped in early London trade as Sen. Charles Grassley, the senior Republican on the Senate Finance Committee, called for the Food and Drug Administration to review its Paxil depression drug. He cited a U.K. investigation that the company held back data on the suicide risk from taking the drug. "I am asking the FDA to take a look at the same information that was examined in the U.K. And I am asking the FDA if we need to change any laws here in the United States," he said

Any politicians with balls as big as Sen Grassley here in the UK?

Stand up and be counted.

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