blogs created to prevent or detect a crime http://www.opsi.gov.uk/acts/acts1997/ukpga_19970040_en_1

This blog is brougt to you consistent with subsection 3 of the Protection from Harassment Act - i.e. blogs created to prevent or detect a crime http://www.opsi.gov.uk/acts/acts1997/ukpga_19970040_en_1



Tuesday 30 November 2010

GLAXO NAMED AND SHAMED IN BOOK SCAM! - but check the details for the bits Fiddaman fails to quote

The book has never been in wide circulation and has not been sold for a few years. Guidelines restricting the use of industry money to support medical journal articles or doctors’ research have come into wide acceptance within the last several years, to try to minimize the influence of companies’ marketing on medical practices.

The book sold about 26,000 copies, including 10,000 bought by SmithKline Beecham for American family doctors and 10,000 purchased by the Dutch pharmaceutical company Organon, Mr. McMillen said. The authors together received a 15 percent royalty of the $120,000 sales, or about $18,000, he said.





Since there are about 100,000 family physicians in the United States, the book reached only a small percentage of them and has probably declined in usage since 1999.



















Drug Maker Wrote Book Under 2 Doctors’ Names, Documents Say


Two prominent authors of a 1999 book teaching family doctors how to treat psychiatric disorders provided acknowledgment in the preface for an “unrestricted educational grant” from a major pharmaceutical company.


http://www.nytimes.com/2010/11/30/business/30drug.html?_r=2&src=busln

Enlarge This Image 



From the book “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care.”

Related





A 1997 Letter From Scientific Therapeutics Information (pdf)






But the drug maker, then known as SmithKline Beecham, actually had much more involvement than the book described, newly disclosed documents show. The grant paid for a writing company to develop the outline and text for the two named authors, the documents show, and then the writing company said it planned to show three drafts directly to the pharmaceutical company for comments and “sign-off” and page proofs for “final approval.”



“That doesn’t sound unrestricted to me,” Dr. Bernard Lo, a medical ethicist and chairman of an Institute of Medicine group that wrote a 2009 report on conflicts of interest, said after reviewing the documents. “That sounds like they have ultimate control.”



The 269-page book, “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care,” is so far the first book among publications, namely medical journal articles, that have been criticized in recent years for hidden drug industry influence, colloquially known as ghostwriting.



“To ghostwrite an entire textbook is a new level of chutzpah,” said Dr. David A. Kessler, former commissioner of the Food and Drug Administration, after reviewing the documents. “I’ve never heard of that before. It takes your breath away.”



The book has never been in wide circulation and has not been sold for a few years. Guidelines restricting the use of industry money to support medical journal articles or doctors’ research have come into wide acceptance within the last several years, to try to minimize the influence of companies’ marketing on medical practices.



The book’s listed co-authors were Dr. Charles B. Nemeroff, chairman of psychiatry at the University of Miami medical school since 2009 and Emory University before that, and Dr. Alan F. Schatzberg, who was chairman of psychiatry at the Stanford University School of Medicine from 1991 until last year.



The letter documenting the relationship between Dr. Nemeroff, a writing company and SmithKline was dated Feb. 4, 1997. It and a “preliminary draft” of the book, dated Feb. 21, 1997, and adding Dr. Schatzberg’s name were released Monday by the Project on Government Oversight, a Washington advocacy group. They were attached to a letter of complaint to Dr. Francis S. Collins, director of the National Institutes of Health. In the letter, Danielle Brian, executive director of the project, and Paul Thacker, an investigator, formerly with the staff of Senator Charles Grassley of Iowa, also cited other examples of what they termed ghostwriting and asked the N.I.H. for better policing of such practices.



The documents were separately obtained by The New York Times from the Los Angeles law firm of Baum Hedlund, which received them as part of discovery in lawsuits against the drug company, now known as GlaxoSmithKline, involving Paxil. Leemon B. McHenry, a bioethicist with California State University, Northridge, who consults for the law firm, said many similar documents remain sealed. “This is only the tip of the iceberg,” he said.



Responding to questions by e-mail last week, Dr. Nemeroff and Dr. Schatzberg emphasized the “unrestricted” nature of the grant from the drug maker to develop the book and said they did most of the work. SmithKline “had no involvement in content,” Dr. Schatzberg said, adding, “An unrestricted grant does not give the company any right of sign-off on content and in fact they had no sign-off in content.”



Dr. Nemeroff said he and Dr. Schatzberg “conceptualized this book, wrote the original outline and worked on all of the content.”



But the writing company, Scientific Therapeutics Information of Springfield, N.J., had developed “a complete content outline” for Dr. Nemeroff’s comment, according to the 1997 letter from one of the company’s officials. The company also said it had “begun development of the text.” The writing company did not respond to requests for comment.



Kevin G. Colgan, a spokesman for GlaxoSmithKline, said the company’s role in the book was described in its preface. In recent years, he added, the company has tightened its internal guidelines for medical writers.



Ron McMillen, chief executive of American Psychiatric Publishing, which published the book, said he reviewed files on it Monday and found no evidence of influence by the writing company or GlaxoSmithKline. But Mr. McMillen also said he had been unaware of the plan outlined in the two-page letter to Dr. Nemeroff.



“This would show more involvement than we would accept,” he said after reviewing it.



The book sold about 26,000 copies, including 10,000 bought by SmithKline Beecham for American family doctors and 10,000 purchased by the Dutch pharmaceutical company Organon, Mr. McMillen said. The authors together received a 15 percent royalty of the $120,000 sales, or about $18,000, he said.



Since there are about 100,000 family physicians in the United States, the book reached only a small percentage of them and has probably declined in usage since 1999. Dr. Howard A. Brody, an author, blogger and professor of family medicine at the University of Texas Medical Branch at Galveston, speculated that family doctors may have had some resistance to a book from a psychiatric press.



Mr. McMillen said the book was co-published with the American Medical Association. He said it was distributed until a few years ago.



Dr. Nemeroff said the book was written to fill an unmet need in educating family doctors and primary care physicians on how to provide adequate treatment for people with mental illness. “Remarkably, the book remains quite accurate and relevant to clinical practice today,” he said.



Dr. Nemeroff said he and Dr. Schatzberg “scrutinized every page and rewrote and edited as we deemed necessary,” keeping control of the final draft.



Dr. Schatzberg said he had not seen the 1997 letter to Dr. Nemeroff. He termed it “a theoretical proposal that bears little, if any relationship to what actually happened.”



Dr. Lo, who is a professor of medicine and director of the medical ethics program at the University of California, San Francisco, said that medical textbooks and handbooks should make it clear — as peer-reviewed journals now do — whose idea it was, who wrote the first draft, and who edited. Dr. Lo and other experts said ghostwriting has receded in recent years with tougher journal standards.



Dr. Nemeroff and Dr. Schatzberg have been listed on other titles, including co-editors of the Textbook of Psychopharmacology, a book for psychiatrists and medical students, whose third edition appeared in 2003. In 2008, Emory University imposed a two-year ban on Dr. Nemeroff receiving N.I.H. grants after a Senate inquiry found that he had failed to disclose at least $1.2 million in industry financing over seven years from pharmaceutical companies, including GlaxoSmithKline.



Monday 29 November 2010

Epilim case shows the flaws in the legal aid regime

Epilim case shows the flaws in the legal aid regime

http://www.guardian.co.uk/law/2010/nov/29/epilim-legal-aid-flaws

Families who claim the epilepsy drug was linked to birth defects have few options left after the LSC withdrew funding






Share Comments (10)

Jon Robins guardian.co.uk, Monday 29 November 2010 13.40 GMT Article history

Epilim, the anti-epilepsy drug. Photograph: Zak Waters/Alamy



Earlier this month a legal action involving 100 families seeking compensation for their children collapsed within weeks of the court hearing after a six-year fight. The families in question are suing over a range of claims for birth defects such as spina bifida, heart damage, cleft palates, deformed hands and feet – some claims are in the region of £6m – which they argue are the result of the children's mothers having taken an anti-epilepsy drug when pregnant.



The Legal Services Commission (LSC), which runs the legal aid scheme in England and Wales, says of its decision to withdraw funding that it "can only spend taxpayers' money where we believe there is a reasonable prospect of success". Taxpayers can make up their own minds as to whether spending £3.25m over the past six years supporting the litigation only to pull the plug within weeks of the case going to court represents good value for money.



I spoke to Emma Friedman, mother of 12-year-old Andy, this week. She took Epilim, manufactured by Sanofi-Aventis, when pregnant to prevent epileptic fits. "Andy is 12 years old now with a mental age of a three year old," she tells me. Her son is at secondary school in a special autistic unit and will need life-long care.



What does Emma make of the LSC's decision to pull the plug? "This sounds cold. But after paying £3.25m so far it doesn't even make good business sense to quit before the taxpayer gets the opportunity for a return on their investment. The taxpayer will pay for my son until the day he dies." She worries this is her son's last chance for justice because of the limitation bar on bringing cases. So where do the families go now? They are looking at judicially reviewing the LSC's decision. But as Emma puts it: "I feel intimidated by the prospect of challenging the LSC, government and the fourth largest drug company in the world."



Sir Menzies Campbell MP, the former Liberal Democrat leader, recently accused the LSC of playing "judge and jury". It's a good point. We are seeing brutal cuts to legal aid – £325m out of £2.1bn. One reason why the LSC was created separate from government was to allow it to make funding decisions without the accusation of being treasury-led or politically-driven. Now the LSC is about to be flung on to the quango bonfire, and its role subsumed into the Ministry of Justice.



Suing a drug company in the UK courts for a case such as Epilim appears to be nigh on impossible. It joins a truly dismal roll call of failed group actions: the 2002 oral contraception pill litigation (fell apart following 44 days of legal argument), the MMR litigation (collapsed in 2003 having cost £15m), and the notorious benzodiazepine tranquilliser cases, which swallowed up £30m of taxpayers' money without even seeing the inside of a courtroom.



It is this "bitter experience" – the LSC's words – that led to the funding regime we now have: there is only £3m available a year for major multiparty actions and any litigation is subject to an annual affordability review.



Increasingly, legal aid isn't there for such complex cases. The expectation from this month's green paper on legal aid is that the private sector steps in and lawyers run these cases on "no win, no fee" backed by after-the-event insurance. The reality is that insurers don't back families fighting multinational drug companies.



Consider the plight of the Vioxx litigants. In November 2007 the manufacturer Merck paid more than $4.85bn to Americans who claim to have suffered heart attacks and strokes as a result of the anti-arthritis drug. By contrast, the UK legal action never really got off the ground. The claimants couldn't get legal aid nor could they find an insurer to back their case. They were left taking their cases to New Jersey where the judge ruled against them on the grounds that their home country had "a perfectly appropriate judicial system". The problem is they could not get their case into court at all.



David Body, the partner at Irwin Mitchell representing the Epilim families, is sceptical about the prospects of funding the case privately. "It's late in the day and there is likely to be an enormous insurance premium to deal with the potential cost for a trial against a multinational drugs company." And as he puts it: "That is why legal aid is there. It is designed to enable people of modest means to get through the courtroom door." Quite; the problem is it's not working.



Jon Robins is a freelance journalist and director of the research company Jures

Sunday 28 November 2010

wikileaks El Pais, Le Monde, Speigel, Guardian & NYT will publish many US embassy cables tonight

wikileaks El Pais, Le Monde, Speigel, Guardian & NYT will publish many US embassy cables tonight, even if WikiLeaks goes down


about 1 hour ago via web

Retweeted by you and 100+ others

http://twitter.com/wikileaks

Wikileaks 'hacked ahead of secret US document release'

Wikileaks 'hacked ahead of secret US document release'


Wikileaks has previously released documents relating to Iraq and Afghanistan

Continue reading the main story http://www.bbc.co.uk/news/world-us-canada-11858637?utm_source=twitterfeed&utm_medium=twitter

Wikileaks War Files

Tidal wave of secret files raises new questions

Key issues in Iraq documents release

Excerpts: Iraq war logs

Pressure for openness

Whistle-blowing website Wikileaks says it is under attack from a computer-hacking operation, ahead of a release of secret US documents.



"We are currently under a mass distributed denial of service attack," it says on its Twitter feed.



It adds that several newspapers will go ahead and publish the documents released to them by Wikileaks even if the site goes down.



The US state department has said the release will put many lives at risk.



Wikileaks founder Julian Assange has said the US authorities are afraid of being held to account.



Wikileaks has said the release of classified messages sent by US embassies will be bigger than past releases on Afghanistan and Iraq.



The newspapers set to publish details of the US embassy cables include Spain's El Pais, France's Le Monde, Germany's Speigel, the UK's Guardian and the New York Times.



The latest leak is expected to include documents covering US dealings and diplomats' confidential views of countries including Australia, Britain, Canada, Israel, Russia and Turkey.

"The material that we are about to release covers essentially every major issue in every country in the world," Mr Assange told reporters by video link on Sunday.



A journalist with Britain's Guardian newspaper, which has been working with Wikileaks on publishing the files, said they would include an unflattering US assessment of UK PM David Cameron.



No-one has been charged with passing the diplomatic files to the website but suspicion has fallen on US Army private Bradley Manning, an intelligence analyst arrested in Iraq in June and charged over an earlier leak of classified US documents to Mr Assange's organisation. "

Scientology cult contract - From Wikileaks

Scientology cult contract


From Wikileaks    http://web.archive.org/web/20101128123214/http://https:/secure.wikileaks.org/wiki/Scientology_cult_contract


•scientology-staff-contract.pdf (click to view full file)


•scientology-staff-contract.pdf (alternative address)

Analysis

No analysis or reportage yet. Please carefully read this document and submit your findings.

Summary



Scientology "enrollment application, agreement and general release" form (section 1).", which according to document time stamps was scanned in from paper form on Sat Apr 26 11:08:04 2008.



Anyone who wishes to attend or participate in one of Scientology's religious services MUST sign this document before they can do so. Section two of the contract effectively defines everything Scientology does as a "religious service".



Those who wish to attend or participate in one of Scientology's "religious services" must sign this document before they can do so. Section two of the contract effectively defines everything Scientology does as a "religious service".



By signing the contract a person agrees that any and all disputes they have with Scientology and its affiliates that cannot be resolved informally will be handled by an internal arbitration system. Under no circumstances will they or anyone acting on their behalf take any sort of legal action against the Church/affliliates/employees. If they (or someone acting on their behalf) does try to take legal action, this contract will be presented as sufficient evidence for having the case dismissed immediately and with prejudice.



By signing this contract a person is also stating that they fully agree with Scientology's opposition to Psychiatry and that they themselves absolutely do not want to be committed to Psychiatric care.



The document's primary effect appears to prevent members of Scientology from suing the Scientology for any abuses, negligence or to regain donated moneys or course fees.

Context

United States

Church or religious organization

Scientology

Wikileaks release date



Sunday April 27, 2008

Primary language



English

File size in bytes



4747281

File type information



PDF document, version 1.6

Cryptographic identity



SHA256 7e34adf08dc0908a50cb8652179af25135eef01f6e969b388c1c5d0dabb725fa

Description (as provided by the original submitter)



This is the Staff Contract all non-Sea Org staff members are required to sign before ANYTHING.



1. Possible partial excerpts, not aware of entire document being released.



2. It demonstrates the control it exerts on its members, and it's hostility to mental health practitioners.



3. Anyone with an interest in the subject.



4. Any ex-member could verify, as well as via the Religious Technology Center (http://web.archive.org/web/20080508162657/http://www.rtc.org/contacts.html)



5. To help increase understanding of what joining the cult entails.

Saturday 27 November 2010

WILILEAKS - D notice revealed

From: Andrew Vallance


Sent: Fri 26/11/2010 12:42



To: Sunday Telegraph; Ian Martin; Sunday Telegraph; Channel Five; Caroline Wyatt; C4 News Desk; Sun; Kevin Brown; Sunday Mail; Mail on Sunday; Five TV; Associated Press TV; William Lewis; Tim Marshall; Press Gazette; Allister Heath; Jonathan Collett; Daily Telegraph; Daily Record; Evening Standard; Daily Star; Independent on Sunday; Observer; Foresight News; Daily Express; Sunday Times; Financial Times; Associated Press; Times; Spark FM; chris wissun; Sunday Mirror; Sunday Herald; News of the World; Tom Newton-Dunn; Stephen Abell; Scotsman; Press Association; BFBS Will Inglis; Will Gore; Mark Birdsall; Guardian; Daily Mail; Daily Mirror; People; Foresight News; Telegraph Legal; Glenmore Trenear-Harvey; Sunday Post; Reuters; ITV News Desk; Independent; Evening Times; Jonathan Grun; Glasgow Herald; Five TV



Subject: DA Notice Letter of Advice to All UK Editors – Further Wikileaks Disclosures



To All Editors



Impending Further National Security Disclosures by Wikileaks



I understand that Wikileaks will very shortly release a further mass of US official documents onto its internet website. The full scope of the subject matter covered by these documents remains to be seen, but it is possible that some of them may contain information that falls within the UK’s Defence Advisory Notice code. Given the large number of documents thought to be involved, it is unlikely that sensitive UK national security information within these documents would be recognised by a casual browser. However, aspects of national security might be put at risk if a major UK media news outlet brought such information into obvious public prominence through its general publication or broadcast.



Therefore, may I ask you to seek my advice before publishing or broadcasting any information drawn from these latest Wikileaks’ disclosures which might be covered by the five standing DA Notices. In particular, would you carefully consider information that might be judged to fall within the terms of DA Notice 1 (UK Military Operations, Plans and Capabilities) and DA Notice 5 (UK Intelligence Services and Special Forces). May I also ask you to bear in mind the potential consequential effects of disclosing information which would put at risk the safety and security of Britons working or living in volatile regions where such publicity might trigger violent local reactions, for example Iran, Iraq, Pakistan and Afghanistan?



As always, I am available 24/7 to offer DA Notice guidance…



Yours Sincerely,



Andrew Vallance



Air Vice-Marshal

Secretary, Defence Press and Broadcasting Advisory Committee

WIKILEAKS - Citizens Commission on Human Rights exposed as a Scientology front

Citizens Commission on Human Rights exposed as a Scientology front - wikileaks


Release date



http://sunshinepress.org/wiki/Citizens_Commission_on_Human_Rights_exposed_as_a_Scientology_front





March 7, 2008







Note







Wikileaks has made public the submission, since the material is no longer available at the link described earlier today.



Download 



http://file.wikileaks.org/file/cchr-mails.zip



File

Torrent

Magnet



Further information







Context



United States



Non-governmental organization



Citizens Commission on Human Rights



Primary language







English



File size in bytes







282977



File type information







Zip archive data, at least v1.0 to extract



Cryptographic identity







SHA256 bcf6936c8d2d4865d1802b334934e4bb72db7b7b2d2a32b494d1a0d0c9473895



Description (as provided by our source)







1. Download link just released into the chat forums at: http://forums.enturbulation.org/viewtopic.php?f=12&t=6059







2. The file contains e-mails between members of CCHR (an anti-psychiatry front group of the Church of Scientology)







3. Likely audience: anyone seeking psychological care for themselves or a loved one.







4. Visit the forum via the link above to join in the discussion of these leaked e-mails, and view the original post by the individual who leaked them. You may private message the individual there.







5. It was leaked for a number of reasons:







- Scientology denies that it is behind CCHR (which is clearly contradicted by the references in the emails)







- It shows, clearly, how Scientologists and the CCHR are deliberately manipulating the media... using false accounts and sock puppetry to skew information.







- It shows just how Machiavellian and hypocritical the CCHR is in their planning and execution of attacks against peer-reviewed medical science.







6. Yes. The CCHR's campaign of misinformation is designed specifically to derail people seeking psychiatric help, and instead funnel them toward Scientology. This nonsense, and lack of peer-reviewed treatment CCHR recommends instead (vitamins, niacin, hot saunas) is likely to harm rather than hel

WIKILEAKS - on twitter - UK Government has issued a "D-notice" warning to all UK news editors

http://twitter.com/wikileaks


. The D-notice is type 1 and type 5.


7:43 PM Nov 26th via web

Reply Retweet . UK Government has issued a "D-notice" warning to all UK news editors, asking to be briefed on upcoming WikiLeaks stories

WIKILEAKS - what America REALLY thinks of its friends .....???

U.S. warns world leaders that new WikiLeaks revelations will 'expose corruption between allies' and show what America REALLY thinks of its friends


By Daily Mail Reporter

Last updated at 5:27 PM on 27th November 2010   

3 million documents set to go online

U.S. diplomats face being kicked out of countries in backlash

Corrupt politicians expected to be named and shamed

Bombshell leak thought to include U.S. assessments of Gordon Brown

Secret talks on return of Lockerbie bomber to Libya may also be leaked

Allegations 'include U.S. backing of Kurdish terrorists'

Blowing the whistle: Julian Assange, the founder of WikiLeaks (pictured earlier this month), is said to be preparing to release more sensitive documents

World leaders were warned last night by America that damaging secrets about their nations were about to be laid bare.

The documents include highly damaging and embarrassing communiques from U.S. embassies around the world, especially from London - revealing the truth behind the so-called 'special relationship' between the U.K. and the U.S.

The U.S. ambassador to London made an unprecedented personal visit to Downing Street to warn that whistleblower website WikiLeaks was about to publish secret assessments of what Washington really thinks of Britain.


The website is on the verge of revealing almost three million documents, including thousands of sensitive diplomatic cables sent to Washington from the American embassy in London.


The bombshell leak is thought to include U.S. assessments of former British prime minister Gordon Browns personality and his prospects of winning the General Election, and secret discussions on the return of the Lockerbie bomber to Libya.


Assessments of current Prime Minister David Camerons election chances and his private assurances to U.S. officials may also be included, Government sources believe.


They fear they will emerge on Sunday in co-ordinated releases in newspapers in Britain, Germany and America.

The British government is so worried that last night it issued a D-Notice, warning that publishing the secrets could compromise national security.

The website has previously released secret details of allied military operations in Iraq and Afghanistan.

Revelations of American brutality in Iraq and Afghanistan created shockwaves, made WikiLeaks notorious and led to its founder Julian Assange - an Australian-born computer hacker - being vilified by governments around the world. He is now wanted for alleged rape in Sweden.

In total, around 2.7million confidential messages between the U.S. government and its embassies around the world are to be released.


Read more: http://www.dailymail.co.uk/news/article-1333532/WikiLeaks-revelations-expose-corruption-allies-U-S-warns.html#ixzz16Vi7rrIV

Tuesday 23 November 2010

GSK countersue seroxatUSERSgroup ???

The Tightening of the Screw - UK Litigation.





Litigation sees David go up against Goliath.



Goliath are currently turning the screw on the David's - money being their ammunition.




Q: What can you gain by trying to get blood out of a stone? Fear, insecurity, confusion?

And they really think this won't go public.



Trust me, it will.    




Fiddly

Dr Douglass Condemns GSK - snake oil salesman


Dr Douglass Condemns GSK


Bad batch proves shots not safe




Let’s stop pretending: There’s no way in hog heaven these swine flu vaccines are safe.


Need more proof? Look north – at least one Canadian is dead and dozens of others are recovering from severe allergic reactions to the vaccine.






Many of those cases were linked to GlaxoSmithKline’s Arepanrix swine flu vaccine, which prompted a recall of 172,000 doses. But by the time word got out, all but 15,000 had been used.


If you already rolled up your sleeve in Canada – too bad. Just be glad you’re still alive to read about it............. zzzzzzzzzzzzzzzzzzzzzzzz zzzzzzzzzzzzzzzzz zzzzzzzz
 
read on

Dr Douglass Condemns GSK

see also  

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Ultra Turbo HG


Get rock solid results for as long as you want

Forget the letdowns and embarrassment

Monday 22 November 2010

Drugs licensing flaws exposed - By Sarah Boseley posted 6 October 04

Drugs licensing flaws exposed


http://nswcnna.blogspot.com/2004/10/drugs-licensing-flaws-exposed.html


Special report: Pfizer advised on how to get antidepressant approved by member of body deciding on application.



A leading figure in the world of psychiatry gave a pharmaceutical company advice on how to get its new drug approved while he was sitting on the committee which was deciding the licence application.



An internal memorandum from Pfizer, the world's largest drug company, says Stuart Montgomery would be happy to become a paid adviser and declare an interest to the Committee on the Safety of Medicines (CSM) once the drug, an antidepressant to rival Prozac, had been through the licensing process.



The drug, sertraline, which acquired the brand name Lustral, became a billion-dollar success, but is now one of several banned from use in children in the UK because of evidence they can cause them to become suicidal. Their use in adults is under investigation.



Dr Montgomery says his ad vice to Pfizer in 1989 was permissible because he was not receiving money from the company at the time. But Kent Woods, chief executive of the drug regulatory body which grants licences on the advice of the CSM, said such conduct was "absolutely unacceptable".



"Not only does each member [of the CSM] on appointment sign a letter ensuring confidentiality but at every meeting, the chair as a matter of routine reminds everybody that proceedings are confidential," he said. If the company had questions, they should have talked to officials of the Medicines and Healthcare products Regulatory Agency (MHRA), not the independent CSM experts.



Critics say the case exposes weaknesses in the drug licensing system, run by a regulatory body which, other papers obtained reveal, it has an unquestioning relationship with drug companies.



That relationship is so close that the pharmaceutical trade body in June drew up a business plan for the regulator, concluding: "Our priorities are aligned."



In the first of a two-part investigation into the influence of the drug companies over doctors and government intimacy between the industry and the regulator.



The MHRA is responsible for licensing medicines and regulating the industry. It relies on the advice of the independent experts on the CSM when it grants a new product licence. These experts, from all fields of medicine, are supposed to declare any pharmaceutical company interests, such as consultancies, fees and shareholdings, and must leave the room when drugs from companies that have paid them are discussed.



During his time on the CSM, Dr Montgomery disclosed payments for lectures and advice from Eli Lilly, the makers of Prozac, and from Organon, Beecham, Merck, Sanofi, Glaxo, Novo, Jouveinal, Duphar, Wyeth and Almirall.



Dr Montgomery, who held a joint post with St Mary's hospital, Paddington, and Imperial College in London, was a psychiatric expert on the CSM. His opinion was crucial in 1989, when the Medicines Control Agency as it was then known was considering an application from Pfizer for a licence for sertraline.



A confidential internal memorandum from Pfizer, dated April 24 1989, which was submitted in evidence to a recent court case in the US, has together with Mind, the national association for mental health, which has been campaigning for better drug regulation. Richard Brook, its chief executive, will today call for an external inquiry. "There is clear confusion about the role that Dr Montgomery was playing in this situation," he said.



"It also makes it very difficult for outsiders to believe there was not a serious conflict of interest when one of the major experts on depression involved in the CSM is actually speaking to a drug company about how they best present their results for licencing."



Dr Montgomery became a professor of psychiatry at Imperial College in 1993. The journal he edits, International Psychopharmacology, regularly publishes company-funded studies of antidepressants, as other journals do. He authors many of the papers, often jointly with other senior figures in the field.



The memo reveals that Dr Montgomery met Pfizer officials at St Mary's. He told them the committee had accepted that the drug was effective but "the safety analyses require re-presentation" and he advised them how to go about it.



He told Pfizer they must appeal against the CSM's initial decision. The memo reveals that Dr Montgomery is not going to declare an interest in Pfizer.



"He would still like to remain a disinterested party at the CSM till the appeal was heard," says the memo. "Thereafter he would be happy to act as an adviser to Pfizer and declare an interest."



The Pfizer drug got its approval first in the UK. Other European regulators were not happy that the data from clinical trials proved it worked.



Dr Montgomery said he had no conflict of interest over Pfizer. "My comments to Pfizer in 1989 were the usual clarification of the objections of the CSM to their application. At that time I had no conflict of interest with Pfizer, I was not a paid consultant, I was not in receipt of research grants from Pfizer, and I did not own shares in Pfizer," he said.



"The extracts from the memorandum make it clear that I was a disinterested party and was not prepared to consider a relationship with Pfizer while an application was under review."



By Sarah Boseley posted 6 October 04

Friday 19 November 2010

AVANDIA informed consent - if u don't like it, don't take it !

AVANDIA informed consent - if u don't like it, don't take it !



http://health.groups.yahoo.com/group/criticalpsychiatry/message/64675




http://www.fileden.com/files/2008/5/6/1899375//Avandia%20-%20HC%20Nov%2018-2010.pdf



AVANDIA® /AVANDAMET®/AVANDARYL® Patient Informed Consent -4- My doctor has recommended one of the following medicines to treat my diabetes (please check one of the boxes below, as appropriate):



â–¡ AVANDIA® â–¡ AVANDAMET® â–¡ AVANDARYL®



Please read this Patient Informed Consent ("Consent") and the individual Consumer Information for AVANDIA®/AVANDAMET®/AVANDARYL® and discuss any questions or concerns with your doctor before you sign this Consent.



Do not sign this Consent and do not take AVANDIA®/AVANDAMET®/AVANDARYL® if there is anything you do not understand about the information you have received.



I am aware that:



AVANDIA®/AVANDAMET®/AVANDARYL® are medicines used in addition to diet and exercise to lower blood sugar in people with type 2 diabetes when all other diabetes medicines taken orally (by mouth), either alone or in combinations, have not lowered blood sugar enough or are not appropriate.



Rosiglitazone, the active ingredient in AVANDIA® and one of the active ingredients in AVANDAMET® and AVANDARYL®, may increase the risk of serious heart problems, including:



• heart failure



• angina (chest pain)



• heart attack (myocardial infarction)



• fluid retention (with or without weight gain)



AVANDIA®/AVANDAMET®/AVANDARYL® should not be used if I have or have had heart problems.



There are other options to treat my diabetes, as explained by my doctor.



There are other risks associated with AVANDIA®/AVANDAMET®/AVANDARYL® that are outlined in the individual Consumer Information for AVANDIA®/ AVANDAMET®/AVANDARYL® and I have been given the opportunity to ask and discuss any questions or concerns about those risks with my doctor.



I understand that in order to be prescribed AVANDIA®/AVANDAMET®/ AVANDARYL®, I am required to sign this Consent.



AVANDIA® /AVANDAMET®/AVANDARYL® Patient Informed Consent -5- My doctor has explained the above to me, I have been given time to read this Consent and the individual Consumer Information for AVANDIA®/AVANDAMET®/AVANDARYL® carefully, and to discuss it with my doctor. I now authorize my doctor to continue/begin my treatment with AVANDIA®/AVANDAMET®/AVANDARYL®.



Patient or Legally Appointed Guardian signature lines are below. AVANDIA®/ AVANDAMET®/AVANDARYL® are not recommended for use in people under the age of 18.



Patient (and Legally Appointed Guardian if applicable) Name(s)



Please Print:________________________________________________________________



Patient / Legally Appointed Guardian Signature:



______________________________________________________________________________



Date _________________________

Wednesday 17 November 2010

Jon Medland - video - APRIL interview "forgets to mention" the Cipramil, why?


A father talks about his medical student son's suicide and the acne treatment Roaccutane from APRIL on Vimeo.


Jon's father, Jonathon Medland Snr, is interviewed by founder of the APRIL charity, Millie Kleve. APRIL stands for Adverse Psychiatric Reactions Information Link ......yet he starngely fails to point out that Jon junior was also taking Cipramil !

Jon Medland - Cipramil (citalopram) suicide ? .... Guardian Oct 2004

The inquest heard that the following day he returned to Manchester where his flatmates noticed that he was uncharacteristically quiet. He began acting strangely and told them he had been experiencing suicidal thoughts.



http://www.guardian.co.uk/society/2004/oct/20/health.medicineandhealth  




Though Mr Medland had been due to see Dr Muston for a follow-up appointment that week, his flatmates urged him to see his GP, which he did on January 12, and was prescribed the anti-depressant Citalopram. The following day, Mr Medland's flatmate found him dead in his room

Tuesday 16 November 2010

Roaccutane - Jon Medland medical student who knew the risks ?

Medical student's suicide after taking acne drugCoroner calls for 'clear warnings' on skin remedy


http://www.guardian.co.uk/society/2004/oct/20/health.medicineandhealth

Share Laura Barton The Guardian, Wednesday 20 October 2004 02.11 BST Article historyA promising medical student killed himself four weeks after being prescribed a controversial acne drug, an inquest in Manchester heard yesterday.



Jon Medland, 22, was in the final year of his medical degree at Manchester University when  he hanged himself at his student lodgings early on January 13 this year.



Leonard Gorodkin, the Manchester coroner, was told that in a short time Mr Medland had been transformed from a "bubbly, outgoing" young man with a love of student life and Manchester United to becoming withdrawn and depressed with suicidal thoughts. Mr Medland had suffered from mild acne for several years, but the inquest heard that he had become self-conscious about dealing with patients.



By last autumn he had tried three different types of antibiotic and various topical treatments, and although he had noticed some improvement in his skin, the acne had not cleared.



Through his own research, Mr Medland had learned of the drug Roaccutane, used to treat more severe cases of acne. Mr Medland was referred by his GP to Dr Haydn Muston, consultant dermatologist at Withington Hospital, Manchester, and attended his first appointment on December 11.



Dr Muston told Mr Gorodkin that it was not standard practice to prescribe treatment at the initial appointment, but as Mr Medland was a medical student and had already researched the possible side-effects of the drug, he wrote him a prescription that day. "I felt Jon wanted to get started," he said.



Mr Medland went home to Devon for Christmas, where his family and his girlfriend noticed nothing unusual about his behaviour, the hearing was told. It was only once he had begun a placement at a medical practice in Shrewsbury on January 5 he began to complain of feeling tired and stressed, and had doubts about his academic abilities.




He told friends and family that he feared his mental state was somehow connected to the Roaccutane, and that he had "read somewhere" that the effects might not cease when he stopped taking the drug. They told him to stop taking the Roaccutane tablets, which he did on January 8.



The inquest heard that the following day he returned to Manchester where his flatmates noticed that he was uncharacteristically quiet. He began acting strangely and told them he had been experiencing suicidal thoughts.



Though Mr Medland had been due to see Dr Muston for a follow-up appointment that week, his flatmates urged him to see his GP, which he did on January 12, and was prescribed the anti-depressant Citalopram. The following day, Mr Medland's flatmate found him dead in his room.



Recording a verdict that Mr Medley killed himself, Mr Gorodkin said: "For a drug to affect a person of a very solid life foundation, if it can lead them to take their own life, then it deserves further investigation, if a link can be proved.



"But I cannot say with any certainty that the effects of the drug Roaccutane led him to take his own life. All I can say is that the warnings that are already present should be made very clearly and strongly."



Earlier this year, European medicine watchdogs announced a review of Roaccutane's safety record, following concern regarding alleged links to suicide and depression.



The drug's manufacturer, Roche, says that 13 million people worldwide have used Roaccutane, and although it is not possible to say how many of these are in Britain, by last January an estimated 375,000 treatment courses may have been prescribed.

Sunday 14 November 2010

will claim compensation for the use of the drug as well as the cost for them to safely come off the drug

Lawyers representing the UK Seroxat Users Group are planning to launch a multi-million pound lawsuit against GSK next month. The 3,500 members of the group allege that the antidepressant is a defective product under the Consumer Protection Act. The members say that they experienced dependency/withdrawal symptoms and will claim compensation for the use of the drug as well as the cost for them to safely come off the drug

http://webcache.googleusercontent.com/search?q=cache:4ZNzX-vz7JUJ:www.youclaim.co.uk/Personal_Injury_News.asp%3Fspid%3D143+seroxat+legal+aid+3500&cd=1&hl=en&ct=clnk&gl=uk


http://www.youclaim.co.uk/Personal_Injury_News.asp?spid=143

Seroxat Litigation - Report of the Committee on Safety of Medicines Expert Working Group on SSRI Antidepressants, 2004 - ‘Regulatory History’

Seroxat Litigation - Report of the Committee on Safety of Medicines Expert Working Group on SSRI Antidepressants, 2004 - ‘Regulatory History’

http://the-uk-seroxat-litigation-chronicles.blogspot.com/

The much publicised Committee on Safety of Medicines (CSM) Expert Working Group (EWG) report “On the Safety of Selective Serotonin Reuptake Inhibitor Antidepressants” published December 2004 has been haled as a victory in raising awareness about the problems associated with the drug class – which it was.

Mark Harvey of Hugh James, BBC Panorama’s Shelley Jofre, the Seroxat User Groups and Campaigners have laid claim to this as their achievement - although the drug regulatory and safety authorities were aware of the and investigating the issues of the drug class’ safety, propensity to cause suicide, dependency and withdrawal problems from the early 1990’s.



The issue of dependency associated with the SSRIs had already been discussed at European level by the Committee on Proprietary Medicinal Products (CPMP) and its Pharmacovigilance Working Party (PhVWP), in December 1998 the PhVWP decided France and Germany should further evaluate this issue resulting in a CPMP position paper published April 2000;



“The conclusion of the CSM and the CPMP was that all SSRIs are associated with withdrawal reactions; however, they are not drugs of dependence.”

on completion of the review on SSRIs drug class safety profile in relation to the dependence, withdrawal reactions and review of suicidal behaviour with SSRIs issue, a further article covering both aspects was published in 'Current Problems in Pharmacovigilance' September 2000.



As a result of the CPMP position paper (2000) product information for all SSRIs throughout Europe were changed in relation to inclusion of withdrawal reactions, UK product information for all SSRI, SNRIs were updated accordingly.



The following excerpt from the CSM EWG report briefly explains the history of the concerns, investigations and actions, early 1990’s to date of it’s publication December 2004



“2 REGULATORY HISTORY

This chapter outlines the regulatory history of SSRIs in the UK with particular referenceto the two mains areas of concern - withdrawal reactions and suicidal behaviour.

2.1 Withdrawal reactions in association with SSRIs

It has been known for many years that symptoms can occur on the withdrawal of antidepressants. Syndromes occurring on the withdrawal of tricyclic antidepressants (TCAs) have been defined and severe reactions have been noted on the withdrawal of monoamine oxidase inhibitors (MAOIs)[1]. Since the early 1990s, it has become clear that the SSRIs can also be associated with withdrawal reactions, although different SSRIs appear to cause withdrawal reactions to different extents[2]. The greatest number of spontaneous reports of withdrawal reactions have been associated with paroxetine. An article in 'Current Problems in Pharmacovigilance' in 1993 highlighted the risk of withdrawal reactions associated with paroxetine[3].



In late 1997, an article entitled 'The Antidepressant Web' by Charles Medawar raised concern that some people may become dependent on SSRIs[4]; this prompted a review of withdrawal reactions and dependence with these drugs. The related antidepressants venlafaxine and nefazodone (which is no longer marketed within Europe) were also included in the review. The CSM considered this issue in early 1998.



The issue was also discussed at European level by the Committee on Proprietary Medicinal Products (CPMP) and its Pharmacovigilance Working Party (PhVWP). At the December 1998 meeting of the PhVWP it was decided that France and Germany should carry out further evaluation of the issue of dependence associated with the SSRIs. The outcome of this review was a CPMP position paper which was published in April 2000[5].

The conclusion of the CSM and the CPMP was that all SSRIs are associated with withdrawal reactions; however, they are not drugs of dependence. Following the completion of a class review of the safety profile of SSRIs and a review of suicidal behaviour with SSRIs, a further article covering these aspects and the issue of withdrawal reactions was published in 'Current Problems in Pharmacovigilance' in September 2000[6].



The CPMP position paper (2000) contained key principles in relation to withdrawal reactions for inclusion in the product information for all SSRIs throughout Europe. The UK product information for all SSRIs and venlafaxine was updated accordingly.



Concern about withdrawal reactions with SSRIs continued and more recently has focused primarily on paroxetine. The BBC's Panorama programmes in October 2002 and May 2003 highlighted the level of public concern.”

The issue of all drugs in the SSRI, SNRI class causing dependency or being addictive had been addressed in the UK and Europe, both the CSM and CPMP had opined that the drugs, including seroxat did not meet the World Health Organisation (WHO) criteria for addiction by April 2000.



This opinion was not changed by the CSM EWG investigation as described in the earlier post “The “Addiction” Issue & Hugh James’ need to change the Patient Information Leaflet (PIL)” that can be found here.



The closing paragraph of the above excerpt draws attention to the recent (2002 to 2004) primary focus being placed on paroxetine (Seroxat) and the “BBC's Panorama programmes in October 2002 and May 2003 highlighted the level of public concern”.



Although the CSM EWG report is quite explicitly centred on all SSRIs and venlafaxine (Efexor) - the media, Hugh James’ Mark Harvey, the Seroxat User Group and Seroxat Campaigners’ selective interpretation of this statement is that Seroxat is the worse drug in the class because recent (2002 - 2004) concern about all drugs had shifted and “focused primarily on paroxetine”; However, would be more reasonable to say the drug Seroxats’ notoriety was generated by the “level” of adverse media coverage and the BBC Panorama’s two Seroxat focused programs?





CMS EWG Quote References





1 - Lejoyeux M et al (1996) ‘Antidepressant withdrawal syndromes’ CNS Drugs 5: 278-292.



2 - Stoukides J A & Stoukides C A (1991) ‘Extrapyramidal symptoms upon discontinuation of fluoxetine (letter).’ Am J Psychiatry 148(9): 1263.



3 - MCA/CSM (1993) Current Problems in Pharmacovigilance 19



4 - Medawar C (1997) ‘The Antidepressant Web.’ Int J Risk Safety Med 10: 75-126.



5 - http://www.emea.eu.int/pdfs/human/press/pp/277599en.pdf



6 - MCA/CSM (2000) Current Problems in Pharmacovigilance 26



7 - Teicher MH et al (1990) ‘Emergence of intense suicidal preoccupation during fluoxetine treatment.’ Am J Psychiatry 147:207-210



8 - MCA/CSM (1992) Current Problems in Pharmacovigilance 18.



9 - Healy D (1999): ‘A Failure to Warn [editorial].’ Int J Risk Safety Med 12: 151-6



10 - Lane RM (1998). ‘SSRI-induced extrapyramidal side effects and akathisia: implications for treatment.’ J Psychopharmacology. 12: 192-214.

Tobin v. SmithKline - Schell first suffered from his nerves in the mid-1980s

Tobin v. SmithKline






In February 1998, Donald Schell, a 60-year-old living in Gillette, Wyoming, became withdrawn and began to complain to his wife Rita of difficulty in sleeping. Schell first suffered from his nerves in the mid-1980s, with approximately five subsequent nervous episodes centred on work stressors or bereavements. Don and Rita appeared to most of those who knew them to be a close couple. They were married for 37 years. They had two children, Michael and Deborah. Deborah married Tim Tobin in 1992 and in 1997 she gave birth to the Schell’s first grandchild, Alyssa. Deborah and Alyssa, now nine months old, came down from Billings, Montana to stay for a few days with Don and Rita in February 1998.







Don’s means of handling his nerves was to take time off work, as he could easily get someone to deputize for him. He went for walks with his wife and spent time talking with friends or with Tim, if he was around, in addition to taking care of his diet. He had got on well with a Dr. Suhany in 1990, so if he remained low after a week or two, either Rita or Don himself would suggest going along to see the doctor. Suhany had first put Schell on Prozac and noted that it made him tense, anxious and jittery, despite the fact that he was on several antidotes such as Inderal, Ativan, and Desyrel. Suhany stopped Prozac and put Schell on imipramine, to which he responded rapidly.[lxxix] What Suhany didn’t know was that Schell might have even been hallucinating while on Prozac. Having responded to imipramine in 1990, in two further brief episodes in the 1990s Schell was put on tricyclic antidepressants and again responded rapidly.







In February of 1998, when Schell began to complain about his sleep, he and Rita went to see a primary care physician, Dr. Patel. Dr. Patel did a thorough examination, which included rating scales that indicated Schell’s main difficulty was poor sleep and that he felt hopeful about the future and thought well of himself. Patel diagnosed an anxiety state and, unaware of the significance of a prior adverse response to Prozac, put Schell on Paxil, without any covering antidotes. Forty-eight hours later Don Schell put three bullets from two different guns through Rita’s head, and then through Deborah and Alyssa’s heads before shooting himself.







After more than a year in a mental wilderness, Tim Tobin sought out Andy Vickery and took an action for wrongful death against SmithKline Beecham, then in the process of becoming Glaxo-SmithKline, the worlds largest pharmaceutical company. I was retained in the case.



http://webcache.googleusercontent.com/search?q=cache:VmoUVgyT6gAJ:www.healyprozac.com/Book/Chapter10.doc+donald+schell+depressed&cd=6&hl=en&ct=clnk&gl=uk

Saturday 13 November 2010

K D Lang's Crying

40 deaths linked to child vaccines - MHRA confirm - source Sunday Times







40 deaths linked to child vaccines over seven years

Childhood vaccinations are suspected to have left two children with

brain injuries and caused 1,500 other neurological reactions

Sarah-Kate Templeton, Health Editor

Published: 24 October 2010



Forty children are suspected to have died as a result of receiving

routine vaccines in the past seven years.



Childhood vaccinations are also suspected of having left two young

children with brain injuries and caused more than 1,500 other

neurological reactions, including 11 cases of inflammation of the

brain, 13 cases of epilepsy and a coma.



The data, disclosed by the Medicines and Healthcare products

Regulatory Authority (MHRA) following a request by The Sunday Times

under the Freedom of Information Act, shows that, since 2003, there

have been more than 2,100 serious adverse reactions to childhood

vaccines, some of which were life-threatening.



Fifteen injections are given routinely to young children as part of

the governments vaccination programme. They offer protection against

diseases such as polio, diphtheria, mumps and measles.



The MHRA says the deaths and neurological reactions should be seen in

the context of the 90m doses of childhood vaccines which have been

given since 2003.



Details of the suspected deaths and neurological problems have been

released just two months after a legal ruling forced the government to

accept that its vaccination programme had left a baby severely brain

damaged.



Thirteen years after first refusing to acknowledge that Robert

Fletcher, now 18, had been left severely brain damaged by the MMR

vaccine for measles, mumps and rubella, the government was forced to

pay him compensation.



Roberts mother, Jackie, who founded Jabs, a support group for

families with vaccine-damaged children, said: It is generally

accepted within the medical profession that only about 10% of

suspected adverse reactions get put forward in the correct way. It is

accepted by the Department of Health that the full scale of the

problem is far greater than these statistics show.



Jake Dukes, 18, from Weymouth, Dorset, was left severely brain damaged

by the whooping cough vaccine, which he received when he was two

months old. He has the mental age of a toddler, is incontinent and

uses a wheelchair. He was awarded £91,500 under the governments

vaccine damage payment scheme.



The family of George Fisher are convinced that the MMR vaccine

contributed to the death of their 18-month-old son. He died 10 days

after being inoculated in January 2006.



His mother, Sarah, a hotel receptionist from Cheltenham,

Gloucestershire, believes that an existing illness made him

susceptible to an adverse reaction to the vaccine. Four months before

receiving the jab, George had suffered a fit brought on by a high

fever. Sarah said: George had had a bad virus. He had been very ill

and had suffered a convulsion due to his high temperature. I dont

think it was just the MMR, but I think it was a factor in his death.

Friday 12 November 2010

Mark Harvey's firm takes legal aid funding then drops depression drug case !!!!

Mark Harvey's firm takes legal aid funding then drops depression drug case !!!!


British firm of solicitors that received legal aid to pursue litigation against Roche five years ago has now dropped the actions,believing that the cases would be impossible to prove.



Copyright 2004 Times Newspapers Ltd  



Roaccutane.Campaigners against the drug believe that the exercise would demonstrate a strong link between use of the drug and suicide.However, a British firm of solicitors that received legal aid to pursue litigation against Roche five years ago has now dropped the actions, believing that the cases would be impossible to prove."About 80 or 90 claimants came forward but we had to report that we did not think the claims could be won," said Mark Harvey, now a partner in Hugh James, the solicitors in Cardiff. "You have to beable to link depression to the drug and it would be difficult to prove that it might not have arisen anyway and to eliminate other causes. Isn't depression a side effect of puberty or acne in any event?



It is going to be difficult to get the Legal Aid Board to reopen this."





Copyright 2004 Times Newspapers Ltd

Acne drug not found to increase suicide risk

People being treated for severe acne should have their mental health closely monitored, a study reports.


http://www.bbc.co.uk/news/health-11734080

But a popular acne drug was not found to increase the risk of suicide, despite previous findings.



The study of 5,700 people, in the British Medical Journal, was carried out at the Karolinska Institute, Sweden between 1980 and 2001.



Acne can have serious psychological effects, say experts.



Severe acne sufferers are commonly prescribed a drug called isotretinoin, also known as Roaccutane, Accutane, Amnesteem, Claravis, Clarus or Decutan.



It has been used since the 1980s to treat severe acne if a course of antibiotics does not prove effective.



But there have been reports linking isotretinoin to depression and suicidal behaviour.



So Dr Anders Sundstrom and his research team from Sweden studied suicide attempts before, during and after treatment with this drug for severe acne.



Continue reading the main story



Start Quote

Acne can have significant psychological effects .”

End Quote

Dr Sarah Bailey



University of Bath

They found that 128 of the 5,700 patients investigated who were taking the drug were admitted to hospital for attempted suicide.



The risk of suicide was highest within six months of ending treatment - but the researchers say this is most likely to be because patients whose acne improved following treatment were distraught if there was no improvement in their social life, rather than anything to do with the treatment itself.



They stress that attempted suicide was a rare event - the figures suggest just one person out of every 2,300 individuals taking isotretinoin will make a first suicide attempt.



Monitor patients



Dr Sundstrom said of his findings: "The underlying condition of acne is a more important factor for suicide attempts. We are not certain the drug adds anything."



Writing in an editorial in the BMJ, Australian acne experts John Sullivan and Parker Magin say that the Swedish research is important given the complexity of the issue.



"It is difficult to tease out the relation between mental health and isotretinoin because acne itself is associated with psychiatric morbidity, including depression."



They also say that the study shows GPs must closely monitor acne patients on isotretinoin.



"During and after treatment with isotretinoin (perhaps, especially, unsuccessful treatment), patients should be carefully monitored for depression and suicidal thoughts."



Dr Sarah Bailey, lecturer in the Department of Pharmacy and Pharmacology at the University of Bath, said: "This is an important paper that strengthens the view that acne itself can have significant psychological effects and that there is a low risk of suicide for some acne patients.



"However, the controversial issue of increased suicide risk with isotretinoin use is not resolved by this paper, which the authors themselves acknowledge.



"Perhaps their most interesting and novel finding is that the risk of suicide is increased AFTER treatment has stopped and therefore it is essential to continue to monitor patients carefully."

Thursday 11 November 2010

Good Relations & Hugh James are carefully controlling Seroxat media


Litigation and individual members’ cases should not be discussed at support meetings.

Contacting the media. Please do not encourage your members to contact the media. The Group, with Hugh James and Good Relations, are co-ordinating a carefully controlled media approach. If a member of the group asks for your advice on approaching the media, please put them in touch with the committee.

Medical advice. Be careful not to give, or appear to give, medical advice.

Please do not contact any organisation or individual on behalf of the Seroxat Users Group unless you have discussed this with the committee first.

Please do not claim to represent the views of the Seroxat Users Group.

Handling the press and making statements


Unless you are promoting the launch of your group, please do not contact the press. Before contacting the press about your group, it is important you contact John Wilkinson of Good Relations. His telephone number is 029 2034 4888 and his email address is jwilkinson@goodrelations.co.uk. Please advise Hugh James and the committee of your contact with the press so that they can be prepared for enquiries.



If you are contacted by a member of the press on any topic, it is important that you do not make any statement, provide information or take part in an interview without talking to John Wilkinson. Please take the journalist’s name, organisation and contact details and promise to get back to them. Do not feel pressurised to answer questions or respond immediately.



http://www.seroxatusergroup.org.uk/Documents/regionalsupport.doc

Seroxat Janice Simmons knew nothing about medical background of Seroxat issue

Andrew Isaac said Date: 2003/06/30 Mon AM 08:30:08



I am in > correspondence with GSK, I wrote the four papers in the info section and > I also spent a very large amount of time analysing the Patient > Information Leaflets for Seroxat from countries around the world - the > resulting document being used by the solicitors. Due to my background as > a medical student I also explain the medical aspect of things to Janice > and Sarah so that we can present ideas to the MHRA in a coherent manner. > For example, Sarah was a bit confused as to how Seroxat work at the > receptor level and I explain this like this to her. > > As to your grave concerns about the management of the group if you can > give me a list clearly giving your explicit concerns I will do my best > to address them along with the rest of the committee. > > My apologies for any distress and inconvenience that this hiccup may > have cause and rest assured that we are on to it! > > Kind regards > > Andrew

Online donations have been drawn on by Sarah V (venn) - a large sum (from Best Magazine) was used > to pay for the website

 Online donations have been drawn on by Sarah V and then Paid to myself > to cover costs I have incurred re: the group. Things like train tickets > for the protest, postage and a large sum (from Best Magazine) was used > to pay for the website. Everything is above board and documented. > > I agree that it must be very frustrating that you cannot access the > website and would also agree that from a member's perspective the delay > in getting the bank account open can be seen as unacceptable. Please > remember that we are doing this in our spare time and work very hard.

http://www.hardwicke.co.uk/barrister-profile/_/14/sarah-venn


http://bobfiddaman.blogspot.com/2010/11/charity-co-ordinator-dr-andrew-isaac.html

"charity co-ordinator" Dr Andrew Isaac replies - confirms seroxatUSERgroup had no bank account

> From: "Andrew Isaac" andrew@seroxatusergroup.org.uk> > Date: 2003/06/30 Mon AM 08:30:08 GMT > To: red.ordead@ntlworld.com> > Subject: RE: urgent seroxat user group > > Dear Claire, > > Many thanks for your email and I will try and answer your questions as > best I can. The Bank account was due to be opened in January this year > but, because the committee members live so far apart it meant that every > one had to send their ID to their branch so that it could then be > forwarded to the branch we wanted to open it at - my local branch! There > was an error on the form that Janice Simmons had to correct, so the form > was sent to her. > > Janice was in the process of moving and caring for her husband John who > is going through the hell of withdrawal. This lost/cost us 3mnths where > it just wasn't possible for her to get to the bank. Since then the > problem has been when Janice has gone to her branch they say they cannot > open the account and it looks as though we will all have to be in the > same place at the same time - this will be on the 10th July - and the > account will be opened then. > > Online donations have been drawn on by Sarah V and then Paid to myself > to cover costs I have incurred re: the group. Things like train tickets > for the protest, postage and a large sum (from Best Magazine) was used > to pay for the website. Everything is above board and documented. > > I agree that it must be very frustrating that you cannot access the > website and would also agree that from a member's perspective the delay > in getting the bank account open can be seen as unacceptable. Please > remember that we are doing this in our spare time and work very hard. I > realise form the perspective of people who use the message board it > looks as though Sarah does everything but that isn't the case. > > Sarah definitely had the most public exposure but we all have > contributed roughly equal amount to the running of the group. I am in > correspondence with GSK, I wrote the four papers in the info section and > I also spent a very large amount of time analysing the Patient > Information Leaflets for Seroxat from countries around the world - the > resulting document being used by the solicitors. Due to my background as > a medical student I also explain the medical aspect of things to Janice > and Sarah so that we can present ideas to the MHRA in a coherent manner. > For example, Sarah was a bit confused as to how Seroxat work at the > receptor level and I explain this like this to her. > > As to your grave concerns about the management of the group if you can > give me a list clearly giving your explicit concerns I will do my best > to address them along with the rest of the committee. > > My apologies for any distress and inconvenience that this hiccup may > have cause and rest assured that we are on to it! > > Kind regards > > Andrew

Wednesday 10 November 2010

Sarah Venn advises me there is no bank account for me to pay funds into - Claire Doherty > Red.ordead@ntlworld.com

-----Original Message----- > From: red.ordead@ntlworld.com [mailto:red.ordead@ntlworld.com] > Sent: 30 June 2003 01:12 > To: andrew@seroxatusergroup.org.uk; ABennett@bluepumpkin.com; > trish@canutewalk.fsnet.co.uk; sarah@seroxatusergroup.org.uk; > lydia@hastingsdiving.com; charliegreig@hotmail.com > Subject: urgent seroxat user group > > Dear committee member, > I would like to donate money to the group. > Sarah Venn advises me there is no bank account for me to pay funds into > Why? > What is happening to the online donations? > Why in six months has a bank account not been opened? > It is vital to the running of the group > I have grave concerns about the groups management > Also the site has now exceeded its bandwidth so members will not be able > to access it. > > This bank account needs to be open, otherwise how can we make donations > and how can the group continue, with such limited funding. This is a > grave worry to me as the seroxat user group is my life line and many > other members too. > I can honestly say without it I wouldnt be here. > Please can you get this sorted > I look forward to your response > > Yours hopefully > Claire Doherty > Red.ordead@ntlworld.com > >

seroxatUSERgroup who lied when they claimed to be a charity - via "wayback machine"

http://web.archive.org/web/20050427235427/www.seroxatusergroup.org.uk/who_we_are.htm







Who We Are





Janice Simmons - Charity Co-Ordinator



"I am the wife of a long term Seroxat user, and therefore I'm particularly interested in those of you who have partners, family and friends that need help in understanding the problems of taking Seroxat. I know how much it can affect all members of a family, as well as the user."



Email: janice@seroxatusergroup.org.uk











Andrew Isaac - Charity Co-Ordinator



"I took Seroxat for approximately four years and despite a protracted withdrawal, I have now successfully withdrawn from the drug. I am 30 years old and am studying medicine."



Email: andrew@seroxatusergroup.org.uk







Can You Help?



We are a self funding, non profit making organisation, and hope that you may be able to make a donation towards funding our operational costs.




Glaxo's Wellbutrin Class Action Lawsuit Certification Denied

Wellbutrin Class Action Lawsuit Certification Denied


Published: October 26th, 2010 • No Comments


http://www.aboutlawsuits.com/wellbutrin-class-action-lawsuit-denied-13699/


A federal judge has refused to grant certification for a Wellbutrin class action lawsuit filed on behalf of consumers who were allegedly forced to pay higher prices for the antidepressant due to GlaxoSmithKline’s attempts to keep a generic form of the medication off the market.

The class action lawsuit over Wellbutrin was brought by the Health & Welfare Plan for the Sheet Metal Workers Local 441 in Mobile, Alabama, in the U.S. District Court for the Eastern District of Pennsylvania. The plaintiffs sought class action status on behalf of all individual consumers and more than 20,000 third-parties, such as health care plans and insurers.



The lawsuit claimed that Glaxo was attempting to delay the release of generic Wellbutrin versions through frivolous patent lawsuits against generic drug makers. Earlier this month, U.S. District Judge Lawrence F. Stengel declined to give the lawsuit class action status, saying that it would be impossible for plaintiffs to prove that the class members were financially injured by Glaxo’s actions.



Stengel determined that it would be impossible to determine which customers would have exhibited brand loyalty to GlaxoSmithKline, meaning that they would continue to buy brand-name Wellbutrin even after generic versions were released. Without being able to determine who would buy generic versions and who would not, the plaintiffs do not have a class action case, he ruled.



Wellbutrin (bupropion HCI), which is manufactured by GlaxoSmithKline, was first approved by FDA as an antidepressant in December 1985. The drug was pulled a year later due to the high number of seizures associated with Wellbutrin side effects, but it was reintroduced in 1989 after federal reviewers determined that the seizures were dose specific and lowered the daily dosage of the drug.



Wellbutrin has come under closer scrutiny recently after a study published in May in the American Journal of Obstetrics & Gynecology suggested that there may be an increased risk of heart birth defects from Wellbutrin when the medication is taken during pregnancy.



Researchers found that mothers who were given Wellbutrin in their first trimester had double the chance of giving birth to a child with a congenital heart problem than mothers who did not take the drug. However, they were not able to establish a cause-and-effect relationship between the drug and the birth defects.

Paxil birth defect mother became pregnant late in life - child plays volleyball and takes tae kwon do lessons

Glaxo officials contend Paxil played no role in Anna’s heart defects. They were most likely caused by genetics or the fact that her mother became pregnant late in life, Chilton Varner, a lawyer for the drugmaker, told jurors.




The deaths of Paxil animal test subjects had nothing “to do with Anna Blyth’s heart defects,” Varner said.


http://www.bloomberg.com/news/2010-11-09/glaxo-failed-to-warn-about-paxil-risks-lawyer-says-at-philadelphia-trial.html

Varner also said Anna, an honor student who plays volleyball and takes tae kwon do lessons, has suffered no lasting effects from her early heart problems.




“She is not on any heart medications and hasn’t suffered any palpitations,” Varner said. “That’s the good news in the case.”

Tuesday 9 November 2010

Baum Hedlund - Paxil / Seroxat's Donald Schell was depressed

extract

'Three-Legged Stool'




There was no question that Donald Schell was depressed. Before taking Paxil, he had been on other antidepressants including Prozac.






Furthermore, there seemed to be no other motivation for the murder-suicide. He had no obvious marital problems and clearly adored his daughter and granddaughter. So the pivotal question of the trial was: Did taking Paxil for two days - one pill each day - cause Schell to go berserk? Or did he become violent because he was already depressed?



This chicken-and-egg-type question had been at the heart of other the other antidepressant trials, as Vickery knew well. He had tried and lost a similar case - Forsyth v. Eli Lilly & Co. - in Hawaii in 1999.



"In Hawaii, I stupidly [bought into their] either/or argument: Was it the drug or the depression? Here I just focused on the drug." By doing so, he reframed the debate for the jury from, "Was it the depression or the drug?" to "Is it possible for the drug to produce a violent reaction in some people?"





http://www.baumhedlundlaw.com/media/ssri/Paxil_murder.htm

The Evidence, However, Is Clear - only 102 votes in entire year

Seroxat withdrawal poll results

Sarah Venn barrister in breech of Seroxat group finance rules !

Finance


1.The funds of the Group, including all donations, contributions and bequests, shall be paid into an account operated by the Committee in the name of the Group at such bank as the Committee shall decide.

2.Group funds must only be spent in furtherance of the objects and activities ancillary to the objects.

3.At least two committee members will be authorised signatories of the bank account, one of which must be the Treasurer.

4.No committee member must withdraw funds from the bank account unless there are cleared funds to cover the withdrawal.




http://www.seroxatusergroup.org.uk/Documents/rulesgroup.doc

Monday 8 November 2010

Devenish Nutrition Ltd v Sanofi-Aventis SA (France) and others [2008] EWCA Civ 1086; [2008] WLR (D) 317

Devenish Nutrition Ltd v Sanofi-Aventis SA (France) and others [2008] EWCA Civ 1086; [2008] WLR (D) 317




CA: Tuckey, Arden and Longmore LJJ: 14 October 2008


http://www.lawreports.co.uk/WLRD/2008/CACiv/oct0.5.htm


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Irwin Mitchell loses vitamins appeal - Class action lobby dealt body blow

Irwin Mitchell suffered a blow in the Court of Appeal last week in a case that could spell the end for US-style class actions in the UK.

http://www.thelawyer.com/class-action-lobby-dealt-body-blow-as-irwin-mitchell-loses-vitamins-appeal/135288.article



In ;2004 ;the ;firm embarked on a mission to bring the first multi-party action for damages. The case was brought against a series of vitamins companies, including Switzerland’s Hoffman-La Roche and Germany-based BASF, which had been on the receiving end of an e855m (£669.94m) fine after being found guilty of colluding on price-fixing.



Irwin ;Mitchell ;was brought ;on ;board ;to ­represent a number of clients from the poultry and animal feeds sector, which alleged that the activities of the companies unfairly inflated the prices they were paying for vitamins.



.The ;lead ;claimant, Devenish Nutrition, a Belfast-based supplier of pig and poultry feed, was seeking a share of the cartelists’ profits, despite being unable to prove that it had made a financial loss as a result of the cartel.



The Court of Appeal was asked to determine whether the claimants were entitled to compensatory damages, exemplary ;damages, ­restitutionary damages and an account of profits.



Irwin Mitchell instructed Christopher Vajda QC of Monckton Chambers and Andrew Burrows QC of Atkin Chambers to argue that compensatory damages alone would not be an ­adequate remedy.



The claimants argued that, if the court ruled in their favour, it would act as a deterrent against other cartelists.



In an ideal world the case would have been brought in the US, where claims such as these are seen as the key deterrent in preventing cartels from being established.



However, here in the UK, where class actions are still unusual, Irwin Mitchell was forced to go to the Court of Appeal after the claim was rejected by the High Court.



The Court of Appeal’s 14 October decision could be another nail in the coffin for the class action lobby in the UK. For several years it has been pushing for a change in UK law to allow more ­people to participate in class actions.



“It’s certainly the end of people trying it on,” said one senior partner close to the case. “These people seem to be encouraged by lawyers who want them to get damages for losses they haven’t suffered. This is a sensible ruling which sits within the law as it is. The judges couldn’t have done anything else.”



According to Cohen ­Milstein Hausfeld & Toll ­partner Vincent Smith, the Devenish litigation is a good example of how cases can collapse if ­collective claimants ;fail ;to ;act ­together.



Smith said: “This wasn’t an unexpected ruling – [the judges] are bound by ­previous precedent. What it does show is that we need to choose claimants very ­carefully and make sure everybody’s involved from the very beginning.”



Smith said the case highlighted an urgent need for a framework on which to bring class actions.



“The Government is expected to respond to the CJC recommendations on class actions shortly and we expect it to come out in favour of the proposals,” he added.



To some extent the ruling recognises that changes are afoot in the class action arena. Yet Mr Justice ­Longmore pointed out that the court cannot act alone.



Longmore J, who sat alongside Mr Justice Tuckey and Lady Justice Arden, said: “The only real argument in favour of an order for an account of profits is the argument of policy that cartels are a notorious evil and the civil courts should in some way provide an incentive for their eradication by making such an order.



“But it doesn’t seem to me to be right for the courts to take this step on their own initiative.



“Neither the law of ­restitution nor the law of damages is in the business of transferring monetary gains from one undeserving recipient to another undeserving recipient, even if the former has acted illegally while the latter has not.”



With this single sentence, Longmore J must have shaken the confidence of every claimant lawyer looking to bring a class action.



“I think the class action lobby are on a hiding to nothing in the UK court,” said one litigation partner. “These are claimants who’ve suffered no actual loss – why should they be entitled to damages?”



But Irwin Mitchell’s lead partner on the case Jeremy Marshall is now planning to seek leave to appeal to the House of Lords. “This isn’t yet over, and the Court of Appeal’s given us the inkling that this should go to the Law Lords,” Marshall said.



It is understood that Irwin Mitchell is working on a contingency fee basis and therefore has a lot ­riding on the success of this case. If the firm wins in the Lords it will certainly be able to say that it won against the odds.



Claimant lawyers have for some time been calling on the Government to improve access to justice by modifying the class action framework and allowing more people to participate. Yet at every corner the lobby is curtailed by current UK case law. Only the case against the BA-­Virgin cartel has been ­successful and that was largely because it was first brought in the US.



And while the defendant has the cash to pay for ­powerful lawyers and the claimant still scratches around for suitable funding, the situation will remain.