Seroxat : The Situation As It Stands : August 2008



(Note : I noticed that the MHRA and GSK were both looking in on this blog today after I posted a lengthy post yesterday, I often wonder what they make of the Seroxat Situation, surely they are aware that this drug needs to be pulled urgently ? So to the MHRA and GSK, how can you sleep at night knowing that Seroxat is destroying lives?)

I set up this blog over a year ago and I haven’t posted or updated it since that time. The reason I originally set up the blog was because I wanted to provide a portal to links documenting the many stories , experiences and news articles about Seroxat and also to bring awareness to the dangers of the drug. I had a terrible and painful experience with the drug myself and I hoped that upon discovering the information provided here , others could be spared the same fate as me. My fate being; a torturous 4 years on Seroxat which not only cost me my sanity at the time but also my mental, physical and emotional health. It took me some years to recover from a full blown withdrawal and the side effects still lingered long after my last toxic dose. I think Paroxetine (Seroxat-Paxil-Aropax) is one of the most dangerous chemicals ever created for human consumption and I think it is high time this medication was withdrawn from the market. It is astounding that it is still available as an “option” for depression and anxiety because as is evident, the case against its efficacy and effectiveness has long overwhelmed its purpose. Seroxat is lethal, and Seroxat should never have been licensed. 

During the past year or so since I originally created this blog ,the Seroxat Story raged on and many other people began to set up blogs and websites about Seroxat. I didn’t update my blog during that time, I just wanted the information to be available in one place so I left it up as a reference blog to provide easy access to links about the drug. Among the many voices now speaking out against the seroxat scandal and the behavior of GSK there are two whom I hold in very high esteem. If you want the definitive Story on Seroxat, the MHRA, GSK and their role in the Seroxat Scandal, you should begin with these two Seroxat blogs; “Seroxat Secrets” and “Seroxat Sufferers – Stand Up And Be Counted” 

http://seroxatsecrets.wordpress.com/

http://fiddaman.blogspot.com/

The sheer volume of information which has come out about Seroxat in the 18 months since this blogs creation is staggering. However, it is also heartening and inspiring to see more blogs and videos about Seroxat appearing on youtube. More brave voices are being heard and It seems the seroxat sufferers did indeed begin to “stand up and be counted”. 

This blog has had tens of thousands of hits in 18 months (the others much more, as far as I know) , and it is interesting to note also that GSK regularly monitor all of the blogs that I am aware of. It never ceases to amaze me just how widespread the Seroxat Scandal became and how many thousands of people’s lives have been negatively affected by Seroxat. It is also shocking to know that this drug is still being prescribed, not just to current addicts of the drug but also to “new users”. The Case against the current sale and promotion of this SSRI antidepressant is blindingly obvious and has been for years. The only solution to the current Seroxat Situation is a gradual banning of the Drug. It should be gradually withdrawn from pharmacy shelves and those currently unable to wean should be guided into a monitored tapering regime. It should not be prescribed to new users and it should eventually be banned from sale. It is defective and dangerous and it has destroyed countless lives. 

Amongst the current news about Seroxat , the following events are worth noting : 

http://www.iht.com/articles/ap/2008/03/06/business/EU-FIN-COM-Britain-GlaxoSmithKline.php

UK agency rules out prosecution of GlaxoSmithKline on Seroxat

The Associated Press
Published: March 6, 2008

LONDON: A British regulatory agency said Thursday that it will not prosecute pharmaceutical company GlaxoSmithKline for allegedly withholding data on clinical trials of Seroxat, an antidepressant drug.

Clinical trials have indicated that people under age 18 who took the medication had an increased risk of suicide.

The Medicines and Healthcare Products Regulatory Agency, announcing the conclusion of a four-year review, said Thursday that there was no reasonable prospect of a conviction in the case.

“The legislation in force at the time was not sufficiently strong or comprehensive as to require companies to inform the regulator of safety information when the drug was being used for, or tested outside its licensed indications,” the agency said. The drug was only licensed for adults.

Glaxo handed over data from clinical trials in 2003 which indicated that patients under 18 had a higher risk of suicidal behavior if they were treated with Seroxat compared to those receiving a placebo. The research also indicated that Seroxat was ineffective in treating depressive illness in under 18.

Andrew McCulloch, chief executive of Britain’s Mental Health Foundation, criticized the agency’s decision.

“It is totally unacceptable to hear that, when information can be made available at speed, young people may have taken their own lives due to a lack of transparency by a pharmaceutical company,” McCulloch said.

Kent Woods, the agency’s chief executive, said he was still concerned that Glaxo “could and should have reported this information earlier than they did.”This investigation has revealed important weaknesses in the drug safety legislation in force at the time. Subsequent legislation has partially addressed the problem, but we will take immediate steps to ensure the law is strengthened further, so that there can be no doubt as to companies obligations to report safety issues,” Woods said.

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So, after 4 years of investigating GSK, the MHRA decided not to prosecute because of “insufficiently robust laws” , which means that basically GSK were let off the hook because of a “loophole”. Children died because of GSK suppressing negative data and inflating the positives of their pediatric seroxat study , the infamous “study 329”, and does justice come? . No, it does not.

There was much outrage about this , particularly in the blogosphere 

Some comment and articles worth checking out about this can be found here : 

(MHRA Official Statement regarding 4 year criminal investigation of GSK) 

http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON014153 

(GSK , Seroxat investigation : the legal questions which must be answered) 

http://fiddaman.blogspot.com/2008_03_09_archive.html

(seroxat secrets : 3 questions for JP Garnier , who after all “has nothing to hide”) 

http://seroxatsecrets.wordpress.com/2008/03/16/3-questions-for-jp-garnier-who-after-all-has-nothing-to-hide/

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It seems to me, that although this investigation concluded with no criminal charges brought against GSK, it did not bring closure to those whose children were prescribed Seroxat and it also brought no justice for those who died from Seroxat induced suicide. The fact of the matter is, by attempting to close this can of worms , the MHRA indirectly opened many others. Many questions will continue to be asked for a long time to come. A crime of that magnitude does not just simply die with a whisper. And while the investigation in the UK came to a sad and unjust end, the situation in the US is only just beginning. For information on the current US investigation, check out these links :

Sen Grassley investigates GlaxoSmithKline and Paxil/Seroxat

http://seroxatsecrets.wordpress.com/2008/08/03/sen-grassley-investigates-glaxosmithkline-and-paxilseroxat/

 

Senator Charles Grassley (R-Iowa), a ranking member of the Senate Finance Committee, launched an investigation of GlaxoSmithKline (GSK) regarding its controversial antidepressant Paxil based on GSK documents collected by Baum Hedlund during Paxil suicide litigation.
See: http://finance.senate.gov/press/Gpress/2008/prg061208.pdf

The documents include a comprehensive report (based on GSK’s internal documents, studies and data analyses) from Harvard psychiatrist, Dr. Joseph Glenmullen. Dr. Glenmullen’s report has been provided to the FDA, which is said to be investigating the report, as well as accusations GSK hid Paxil’s link to suicidal behavior.

Concerned about the public health implications of the documents obtained in the Paxil suicide litigationBaum Hedlund asked GSK to allow it to share the documents with the FDA, but GSK declined to allow the firm to do so.

In addition to the Grassley investigation, Baum Hedlund attorneys were contacted by the Department of Justice for information concerning GSK’s marketing practices related to Paxil. Attorneys from the firm met with DOJ and other government attorneys and staff in 2007.

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It is not surprising to me that GSK were not prosecuted in the UK. They operate within a status in England which could only be described as “above the law”. They are a UK company and they contribute huge revenue to the UK economy. They have their monetary tentacles in almost every facet of the British health system,  from pharmaceutical research, regulatory affairs , sponsorship, universities, grants, scientific discovery , patient groups to corporate advice to the UK government. They are a certifiable English institution which provides a lot of employment and their stocks and shares are insidiously intertwined with the UK  economic system. Their sphere of influence is huge in the UK and it is also very powerful. Personally I think the UK failed to bring criminal charges against them because they dare not bite the hand which feeds them. It will be interesting to see how the scenario plays out in the US, they have power there too, but nowhere as close to what they yield on their home turf of England. Maybe the case against Paxil (Seroxat) there will be very different? Is GSK above the Law in the US? Or do the American authorities perceive GSK as an arrogant foreigner who dares to commit corporate crimes on American soil? The answer remains to be seen.

http://www.pharmalot.com/2008/06/us-investigation-into-glaxo-and-paxil-widens/

• Pharma Blog » 2008 » June » 20

US Investigation Into Glaxo And Paxil Widens


A Justice Department investigation of Glaxo’s handling of the marketing and safety research of its antidepressant, appears to be widening, The Wall Street Journal reports. The drugmaker confirmed that a previously disclosed Colorado-based Justice Department investigation of marketing practices also includes the US Attorney’s office in Boston and is being coordinated by the agency in Washington.

At a meeting convened in Boston by an agency prosecutor last year, plaintiffs’ lawyers representing families suing Glaxo say they were asked about info, documents and depositions concerning Paxil’s potential link to suicidal behavior in adolescents and adults, and how the company portrayed that risk to doctors and the FDA, the Journal writes.

This follows a recent demand by Chuck Grassley, the ranking Republican on the Senate Finance Committee, for an FDA investigation. Glaxo issued a statement to the paper saying it has responded to questions from the government and cooperated fully with the department, but couldn’t comment further, but has requested a meeting with Grassley’s staff to clarify “misunderstandings.”

The lawyers, George “Skip” Murgatroyd and Karen Barth Menzies, said in interviews that they were asked in detail about info they had collected for lawsuits about what Glaxo told the FDA about Paxil’s potential risk of suicidal behavior, between 1989 and 1992, while the drug’s approval was pending, the Journal writes.

They were also asked if they had info about any activities by company reps involving the promotion of Paxil’s safety and efficacy for teens and children, they told the paper. “They (government officials) wanted to know about the research Glaxo did that said there were no suicidality problems, and what the data really showed,” Murgatroyd tells the Journal.

Glaxo says it didn’t promote Paxil off-label to adolescents. However, the paper writes that, in 1998, the FDA sent a warning letter to SmithKline Beecham, which merged with Glaxo Wellcome in 2000, about a T-shirt distributed “by or on behalf of SKB” at a children’s health affair in Florida, saying the T-shirt “is promoting an unapproved use of Paxil.”

In setting up the conference, Menzies tells the paper, Jasperse told her his efforts “could take a while.” The Justice Department said it doesn’t comment about ongoing cases. A different witness who testified later in Boston confirmed to the Journal that he was asked about Paxil’s safety data, but he declined to give the date of his appearance.

The Justice Department was particularly interested in controversial documents disputing research conclusions that Glaxo submitted to the FDA on suicidality. Those documents had been sealed at Glaxo’s request, but the Journal reports the Justice Department asked Glaxo to release confidential material to them prior to their meeting.

In the meeting, Justice officials asked detailed questions related to a controversial medical analysis paid for by Glaxo that has become known as the infamous Study 329, which indicated Paxil was safe and efficacious for teens and children. You can read about 329 here.

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.

And this is interesting: Glaxo hasn’t allowed Baum Hedlund’s lawyers to share with the FDA the same sealed info the company gave the Justice Department. Glaxo’s outside counsel wrote, “If the FDA wanted additional information, such as the internal documents you propose providing it, they could have requested them from GSK,” in an October 15, 2007, letter. This is the letter.

This past March, UK authorities concluded a four-year investigation on whether Glaxo failed to inform regulators in a timely manner about a link between Paxil and suicidality in children and teens. But the government didn’t pursue a criminal prosecution of Glaxo because UK laws were unclear on whether companies were obligated to report certain drug data.

But the regulator said it was “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.”

As we can see, there are many questions which still need to be answered about Seroxat. GSK was under pressure from the UK regulator to reveal the truth about Seroxat in the UK, but they say because there was no chance of a conviction , they could not file criminal charges. Personally I find it strange that the UK authorities failed to secure a criminal conviction. Surely they would have known from the very beginning that GSK would have used the “loop” hole to get off? Why did they investigate GSK for four years if there was no possibility of a conviction? What documents did they find and who were the witnesses that refused to be interviewed? And why were they not forced to be interviewed? It was after all a “criminal investigation”. Some people might interpret the outcome as another “cover up” by the MHRA. Some might perceive it as a “white wash”. Personally, I am not sure, all I know is my instinct tells me that something stinks about the whole thing. I can only imagine how the families of people who committed suicide in a “seroxat induced-lapse of reason” feel. Disappointed , angry and let down again, I would imagine. We can only hope that the US authorities do not fail in their investigation of Seroxat (or Paxil, as it is called in America). People need closure. And they deserve it.

There are some interesting points raised relating to the GSK Seroxat investigation in the UK, they are contained in a letter from Kent Woods (MHRA CEO) to (ex) GSK CEO , JP Garnier and the subsequent reply by a representative of the company.

Links to the correspondence can be found here :

http://seroxatsecrets.wordpress.com/2008/03/09/jp-garnier-glaxo-has-nothing-to-hide-prove-it-then-jp/

http://fiddaman.blogspot.com/2008/03/kent-woods-sycophantic-letter-to-jp.html

letter from the Kent Woods at the MHRA to JP Garnier:

Dear Dr Garnier

I am writing to advise you that the Medicines and Healthcare products Regulatory Agency is today announcing the conclusion and outcome of its investigation into a number of allegations regarding GSK, in particular that the company withheld from the MHRA important clinical trial data relating to the safety and efficacy of Seroxat in children and adolescents, and promoted that product for use in this age group despite safety and efficacy concerns.

In immediate practical terms, the outcome of the investigation is that, having considered our investigation report, government lawyers have decided not to pursue a prosecution of GSK. Their view is that the law at the time these events took place did not require a pharmaceutical company to inform the regulator of clinical trials date in groups for whom the medicine was not licensed, and that there is insufficient evidence of GSK promoting the product for “off-label” use in under 18s. We will today be issuing a press release to confirm that, and will be publishing on our website a short report setting out the conduct and conclusions of the investigation. I am attaching both the press release and the report for your records.

This is the immediate practical outcome but there are a number of other issues arising from the process. There is obviously a need to tighten the law to make it absolutely clear that pharmaceutical companies have a legal responsibility to inform the regulator of any information that changes the benefit risk profile of their products, regardless of whether the information relates to a licensed indication. We will be using the current European Commission consultation on pharmacovigilance regulations and other opportunities to press for changes to the law in this area.

Such a course of action should be unnecessary in an industry which relies so heavily on public trust and aspires to high ethical standards. I would have thought it self-evident that such information should be made available promptly to the regulator in order that action can be taken to protect public health. However, that moral responsibility now needs to be insisted up by the unambiguous force of law.

You will be aware that we have reviewed a large quantity of documents from GSK. Legal provisions prevent us from releasing publicly any information gained under our statutory powers in the course of a criminal investigation. However, there has been a significant level of quite legitimate public interest in this case, and I would there like to release that information into the public domain. This of course requires your consent. GSK has regularly asserted that it has nothing to hide in this matter and so I should be grateful if you could confirm in writing your consent to the release.

Finally, I have no doubt that the content of this letter will be the subject of numerous Freedom of Information requests to the Agency in the coming weeks. The MHRA takes the view that any considerations of confidentiality are outweighed by the public interest in disclosure, and we will therefore be publishing this letter today alongside our investigation report.

If you have any queries about the contents of this letter, please do not hesitate to contact me.

It is clear that Kent Woods is far from satisfied with GSK’s conduct regarding the submission of Data about Seroxat harming children. It is also obvious that he is on some way rebuking JP Garnier and offering him the chance to possibly redeem the company by releasing all the data into the public domain. The letter from Kent Woods did receive a response, but it is far less interesting, and also in typical GSK style it was more of a standard corporate mantra and interestingly, (but not surprisingly) Garnier did not reply personally. 

A link to JP’s response can be found here :

http://seroxatsecrets.wordpress.com/2008/04/24/glaxo-refuse-to-co-operate-with-the-mhra-once-again/

“Finally, it is our strong wish to be as transparent as possible in disclosing information around this investigation. However, from GSK’s standpoint there are legitimate concerns which would need to be addressed prior to any disclosure. These include, for example, the identification of individual employees, independent clinicians and patients, as well as the need to preserve commercial confidentiality of certain information. On this basis, we would be happy to consider requests for information, under the Freedom of Information Act, on a case by case basis in relation to specific documents or categories of documents.”

Basically what GSK is saying here is , if you ask for specific information about the Seroxat criminal investigation we “might” give it to you. But how is the MHRA supposed to know what to ask for when it does not know what the documents are? Again, it seems that GSK have bamboozled the MHRA, and personally I think the only transparent thing about this exchange is the weakness of the MHRA and the arrogance of GSK.

On the Subject of “revelations” , amongst the many interesting news which surfaced about Seroxat this year was Dr Peter Breggins testimony. According to Breggin, GSK duped the FDA by doctoring the original clinical trials before submission for a license.

A link to Dr Breggins “Paxil-Seroxat revelations” can be found here :

http://www.huffingtonpost.com/dr-peter-breggin/the-fda-wants-to-stop-you_b_107162.html

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 byTheWall 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.

Although this information is hardly new to those of us who have researched Seroxat for many years now, it was widely publicized this time, even the Wall Street Journal did a piece about it. What I find shocking about this whole sordid affair is not that GSK duped the FDA and the MHRA, or GSK suppressed data or GSK deceived the public about Seroxat side effects, Seroxat induced suicide and Seroxat withdrawal. All that is bad enough, but what is worse is that there has been virtually no outcry from the medical community. Where are all the GP’s, Doctors and Psychiatrists who prescribed this toxic junk? Why are they not speaking out? Why are GSK still allowed to license drugs? Why are they not shunned by the medial community? Surely, this news should cause utter condemnation from every corner of the world of medicine, why is it always the patients who have to carry the burden of bringing awareness to all this? Why is a drug which increases the chances of suicide still being prescribed to vulnerable people? 

An answer could be found perhaps in the other big news about Seroxat in 2008

News concerning an investigation into Dr Martin Keller of Brown University. Dr Keller was involved in the infamous GSK “Paxil Study 329”.

http://seroxatsecrets.wordpress.com/2008/07/16/pressure-builds-on-marty-keller-as-grassley-senate-finance-committee-probe/

http://www.pharmalot.com/2008/07/grassley-targets-browns-keller-over-grants/

Among the 30 or so physicians at two dozen universities that the Senate Finance Committee is probing concerning disclosure of grants from drugmakers is Martin Keller, a psychiatrist at Brown University who is a controversial figure for his role in studying Glaxo’s Paxil antidepressant. The committee, according to sources familiar with the investigation, sent a letter to Brown as part of its investigation. We are awaiting a reply from Brown and will update you shortly.

In recent weeks, the committee has acknowledged focusing on three academic psychiatrists – Harvard University’s Joe Biederman, Stanford University’s Alan Schatzberg and the University of Cincinnati’s Melissa DelBello. Last week, Chuck Grassley, the ranking Republican on the committee, also asked the American Psychiatric Association to open its books (read the e-mail here).

Keller, you may recall, was the lead author of an infamous study published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry that Paxil, which is known as Seroxat in the UK, was “generally well tolerated and effective for major depression in adolescents.” Known as study 329, the findings were used to widely promote the drug, which became a huge seller.

However, the study was later held in disrepute after it was learned the results didn’t tell the whole story. In fact, 329 was one of three studies cited by former New York Attorney General Eliot Spitzer, who filed a suit charging Glaxo with “repeated and persistent fraud,” alleging the drugmaker had promoted positive findings, but hadn’t publicized unfavorable data (back story).

As it turns out, study 329, which already had a sordid history that included ghostwriting charges (here’s some background), were worse than imagined. A recent study in the International Journal of Risk & Safety of Medicine disclosed that, after sifting through some 10,000 documents that surfaced during Paxil litigation, highly selective reporting was used to skew the results favorably.

Curious to hear how Keller explains the process by which study 329 was drafted? Then feel free to wade through this lengthy deposition from September 2006 in which he discusses the role played by Scientific Therapeutics Information in preparing the study (see pages 242-266). You can also read more about Keller in the recent book about Paxil, Side Effects, by Alison Bass.

It seems to me that the medical community at large has remained silent about the Seroxat scandal because the medical community is complicit also in the Seroxat Scandal. So instead of condemning it, they choose to ignore it, but like a bad smell with a stink of epic proportions , the scandal of Seroxat will not go away. Another interesting development in so far as patients speaking out about the Seroxat debacle came in the form of a meeting between Seroxat Users Group (SUG) and the MHRA. The Audio of this meeting was recorded and released into the public domain by the mental health advocacy blog “Furious Seasons”. For those interested in gaining an insight into the attitude of the MHRA and their role in Seroxat, this audio is essential listening.

A Link to the MHRA-SUG meeting can be found here 

http://www.furiousseasons.com/archives/2008/05/recording_british_paxil_users_meet_with_brit_fda.htm

There was also a transcript of this meeting which was made available 

http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON014153

Another interesting audio recording which made its way on to the web from the BBC was an interview with (ex) GSK CEO JP Garnier. When asked about the Seroxat Scandal, Mr Garnier rudely abandoned the live interview and walked out of the broadcast. Read into that what you will. Personally, I gained more insight into the GSK corporate mindset from this short audio recording than I have from 6 years of researching the Seroxat Scandal. It’s well worth listening to.

See and Hear the BBC Audio Interview of JP Garnier here :

I won’t personally comment on this recording, I think it speaks for itself. 

During this year a book was written about Paxil (seroxat) study 329, it was written by Alison Bass

http://www.alison-bass.com/

Side Effects: A Prosecutor, a Whistleblower, and A Bestselling Antidepressant on Trial

Buy the Book

Buy Alison Bass´ books at your local independent bookseller (booksense.com) or online fromAmazon.com.

bookjacket

“Alison Bass has put on trial in her book far more than just a bestselling antidepressant–she has used the case of Paxil to expose the unsavory and self-serving relationships among members of the pharmaceutical industry, psychiatrists, and members of the FDA. And she does it in a book that has the brio of a crime thriller….”-The New England Journal of Medicine

I have not read the book yet, although I am pretty sure I would be knowledgeable about most of its contents, as most of it can be found in earlier posts of mine on this blog. Actually, I could have written the book myself and maybe I should have. But anyhow, it is good to see at least some aspects of the Seroxat Scandal in book format.

On the subject of books, there is another Paxil related book on its way. It is a very worthy project by another Seroxat sufferer, Shelly Hart. Shelly is documenting paxil withdrawal stories , for those that might be interested, you can contact her through her blog or videos about Paxil on Youtube (the blog and video’s are well worth checking out) :

http://shelly-hartheaven.blogspot.com/

Another topic which has always concerned me in relation to Seroxat is its effect on the unborn and newborn infants. I wrote a post on this blog over 18 months ago about the link between damage to the fetus and ingestion of Seroxat during pregnancy. I called It “paroxetine womb” . For more information about Seroxat effects on the fetus and the damage it can cause I suggest a read though the following blog “Big Pharma Victim”. The blog itself is written by the mother of Manie. Manie’s heart was damaged by Seroxat as his mother Julie took it during Pregnancy and was not warned of the dangers. The blog pulled at my own heart strings and I think Manie and all the other babies born with defects deserve to know why their mothers were not warned about the dangerous and deadly effects of Seroxat-Paxil. Check out Manie’s blog here :

http://bigpharmavictim.blogspot.com/

There has been so much news about Seroxat – Paxil so far during the last year that it is difficult to wade through, but thankfully , Bob fiddaman of “Seroxat Sufferers” has updated his blog almost daily, as has the author of “Seroxat Secrets” , so for more news stories, comment and articles relating to the Seroxat and Paxil Scandal, Please check out both blogs.

http://fiddaman.blogspot.com/

http://seroxatsecrets.wordpress.com/ 

On a (almost) final note for now from me, here are some more Seroxat-Paxil related articles which I think are very relevant and worth exploring further.

The first is an article about Paxil (Seroxat) promotion in Japan

It is a an excellent piece of journalism and also provides a valuable insight into how GSK markets Paxil in other countries. People have said that GSK and other pharmaceutical companies market the disease before they market the drug and I think this article illustrates that concept.

http://query.nytimes.com/gst/fullpage.html?res=9800EEDD133FF931A1575BC0A9629C8B63&sec=health&pagewanted=all

Here is an Excerpt :

Did Antidepressants Depress Japan?

Like the Bush administration, GlaxoSmithKline has spent the last four years staying relentlessly on-message. Its 1,350 Paxil-promoting medical representatives visit selected doctors an average of twice a week. Awareness campaigns teach general practitioners and the public to recognize the following symptoms of depression (the translation is the company’s): ”head feels heavy, cannot sleep, stiff shoulders, backache, tired and lazy, no appetite, not intrigued, feel depressed.”

The psychiatrist Yutaka Ono advocates raising awareness about depression, but GlaxoSmithKline’s marketing made him uncomfortable: ”They ran a very intense campaign about mild depression where a beautiful young lady comes out all smiles and says, ‘I went to a doctor and now I’m happy.’ You know, depression is not that easy. And if it is that easy, it might not be depression.”

Whatever misgivings Ono and other doctors may have about the medicalization of mild depression, it has been a resounding financial success. As one psychiatrist, Kenji Kitanishi, noted wryly, ”Japanese psychiatry is in the bubble economy now.” Between 1998 and 2003, sales of antidepressants in Japan quintupled, according to IMS Health. GlaxoSmithKline alone saw its sales of Paxil increase from $108 million in 2001 to $298 million in 2003. According to the company, during one seven-month ad campaign it ran last year, 110,000 people in a population of 127 million consulted their doctors about depression.

On the subject of Paxil In Japan, it seems that the UK, US and Canada are not the only places to experience cases of Seroxat and Paxil induced suicide. This article is from 2007.

http://www.hkllp.com/paxil-news/japan-sees-an-increase-in-suicide-among-paxil-users-2.html

Japan sees an increase in suicide among Paxil users

June 28, 2007
A Japanese health official says that cases involving suicide or suicidal behavior among patients taking Paxil were 13 times higher last year than in the previous year. The Minister of Health, Labor and Welfare says that approximately 920,000 people in Japan suffered from depression during 2005.According to reports by doctors to Japan’s Pharmaceutical and Medical Devices Agency, 15 patients taking Paxil committed suicide last year, compared with only one in 2005. An additional 24 patients attempted or contemplated suicide in 2006 while taking Paxil, compared with only two patients during the previous year.

In addition to the possible link between Paxil and suicide, reports suggest that birth defects in babies born to mother taking the antidepressant may be another possible Paxil side effect. In 2006, GlaxoSmithKline, the drug’s manufacturer, added a “black-box” warning to the drug’s labeling in the U.S. The label was designed to warn patients and doctors of the risk of suicide in children and adolescents taking Paxil. The Food and Drug Administration issued a warning about the risk of Paxil birth defects in 2005. Despite these measures, however, neither the FDA nor Glaxo have issued a Paxil recall.

—-

Another very sad article which caught my attention this year is the case of Sara Carlin , Sara was 18 when she killed herself in Paxil induced despair. More about Sara can be read here on the blog “Death By Paxil” (by Euchred).
Sara is one of many young persons who were driven to Suicide from Seroxat’s disturbing and frightening side effects. One such side effect is Akathisa, which is basically an inner turmoil and restlessness which literally drives sufferers to the absolute edge of sanity and reason. And because Seroxat also disconnects people from their minds and emotions through side effects like depersonalization and de realization for some users this proves too much to bear. Having experienced them myself, i know how this drug negatively affects the human mind and can induce a state of absolute physical and mental torture. My sincerest sympathies go to Sara’s family who were brave enough to speak out and have this letter printed in memory of their daughter.
July 16 2008

My Darling Sara,

Happy Birthday Baby.

July 21 1988 was such a happy day for us. You were such a gift and remained a gift for 18 short years. I guess that counting the birthdays you will never celebrate lets me age you in my mind;but the pictures and the memories all stay the same, no new ones to add. You only lived 18 years and nothing will ever change that. I miss you so much ‐ we all miss you so much. The pain is really not speak able, the intense longing unbearable. Your family, friends, and teachers they all are in shock at losing you. Even strangers wrote on your face book: “Sara, you probably don’t remember me, but you tutored me in Math, you were so beautiful and smart and made me feel so good about myself”. Your math teacher and the students you helped talked about your gifted nature in teaching others not as fortunate as yourself Your school hockey team had a service for you and Mr. Mac and your team was stunned in sorrow. You were so excited your last year of high school. You took calculus the summer before so that you could get top marks in your remaining courses. You got 98% on that calculus and you were so proud of yourself. You got accepted into Western Health Sciences and were set you go after your dreams. But you got a bit anxious in your last semester and went to the doctor about your anxiety. I didn’t agree that you should take Paxil® but you said the doctor said it would make you feel better. You told you sister that it made you “not worry about things”. It seemed to me that you became unwell when you started this antidepressant you had bad dreams, had trouble sleeping, started to go out more and stay up late, quit hockey. Then in the summer you became so tired and lethargic we found by September that you had mononucleosis affected by the medication you were taking. You told your doctor you had trouble sleeping and were not feeling well so she gave you sleeping pills, and when you couldn’t sleep through the night she gave you another antidepressant to take along with the Paxil® to help you stay asleep. When we questioned this you said the doctor knew best and didn’t agree that you should come off the Paxil®; and in fact doubled the dosage. Well, a few months later, you hung yourself in desperation. Afraid to go to sleep and face your dreams, sitting at your computer half way through taking off you make‐up, you decided to cut a length of electrical cord that your dad had left out to wire some lights, and you ended your life in an instant. Oh my God Sara, I am so sorry that I didn’t realize the depth of your pain, that I didn’t take you away and get you off these prescription drugs. We found out after, when we looked into the drugs that we had trusted to your doctors – that there was a Health Canada Warning about Paxil® to not prescribe the drug to anyone under 19 years of age, and to carefully take them off if they were currently on the drug. You were only 17 and you were prescribed this drug. If only we knew this before, but no one told you or us about the hazards of these drugs. Your dad is doing everything he can to help other families – there are so many others who are suffering as you did. Your dad’s life purpose now is to do everything he can to warn others of the dangers of these drugs. 

We have some of you friends coming over on Sunday to celebrate the beautiful life you lived. 

Wish you were here too.

With All My Love, Mom XXX OOO

Another interesting web site about Paxil-Seroxat which also sprung up in 2008 was

http://www.paxilharmschildren.com/

                                                                                                                        This web site was developed with the intention of bringing awareness to ordinary Canadians, and the general public worldwide, the dangers of the prescription drug Paxil  ( paroxetine HCL ), as it is marketed and known in Canada, and as Seroxat in the United Kingdom (UK), by the GlaxoSmithKline company (GSK).

This site is especially dedicated, in bringing attention to the deaths and damage that Paxil has caused, and continues to cause children, adolescents and young adults.

It would not be necessary to develop and maintain a web site such as this if GSK was an ethical pharmaceutical company, and if our doctors that prescribe Paxil were properly educated in its risks, and did provide proper medical care and monitoring of their young patients.

We truly believe that the medical community has relinquished their responsibilities to their patients, in favour of large pharma companies such as GSK.  We believe that this in part due to the slick, multi-billion dollar marketing campaigns targeted toward our primary care physicians.

It is very sad that we can no longer rely on our family doctors to protect us and our children…

 

Here is just one paragraph from the official GSK Paxil monograph (in quotation marks), a whopping 52 pages no less,  describing some of the very nasty negative effects associated with this drug.

And last, but by no means least ,another blog from a UK seroxat sufferer which contains links to more info about the drug, the MHRA/FDA and also petitions to the UK prime minister in relation to the drugs effects.

The Seroxat Web Log

http://shutah.wordpress.com/

News and Views about Seroxat/Paxil/Paroxetine

—-

For those of you who are currently taking Seroxat (paroxetine -Aropax -Paxil)and happen to stumble upon this blog searching for information on how to get off it or deal with side effects etc, I recommend you visit the following ” SSRI withdrawal forums” and ”  Paroxetine advice websites” for guidance on how to do so safely and effectively.

http://www.paxilprogress.org/forums/

http://www.seroxatmad.co.uk/

http://www.seroxatusergroup.org.uk

http://www.network54.com/Forum/182310/


Seroxat Link 9 : Side Effects Galore : PIL 1996 to 2006


In this post I am going to compare the differences and changes between the current (2006) Seroxat PIL ( Patient Information Leaflet) and the PIL from twelve years ago (1996)

There is an earlier one from 1991 ( But it is sensitive information apparantly and I cannot post about it)

So, I will focus mainly here on some key points from these two PIL’s. You will notice the differences between them and how the side effect profile of seroxat has increased massively in size in a decade, it is really quite remarkable. Just reading the sheer volume of “official” Seroxat side effects added to the 2006 PIL would make anyone feel depressed or anxious… ( not to mention dizzy and nauseous) (My comments will be in brackets in italics after each point)

    PIL 1996

:

What is “Seroxat”?

Everyone has a substance called Serotonin in their body. Low levels of Serotonin are thought to be a cause of Depression and other related conditions. This medicine works by bringing the levels of serotonin back to normal. ( Unproven pseudoscience nonsense )

Seroxat works by relieving symptoms of depression and any associated anxiety. It also treats obsessions , compulsions and panic attacks. These tablets are not addictive. Most people find that Seroxat does not affect their daily lives . ( Not Classed as Addictive, but does cause Dependence which is Addiction , and does cause withdrawal which is a criteria of physically addictive substances )

The usual dose to treat depression is 20mg a day but your doctor may tell you to take up to 50mg a day.
Some people find that if they suddenly stop taking these tablets they feel dizzy, shaky, sick, anxious, confused or have tingling sensations. They also may have difficulty sleeping, and have vivid dreams when they do sleep. But these symptoms are unusual and generally disappear after a few days. ( never proven to work over 20mg )

If you stop taking your tablets too soon your symptoms may return. Remember you cannot become addicted to Seroxat.
( Symptoms such as withdrawal? You can become addicted to Seroxat )

Does “Seroxat: cause side effects? Any medicine can cause unwanted effects, with Seroxat any side effects are usually mild and go away after a few weeks. The most likely side effect of seroxat is that you might feel slightly sick. When taking Seroxat some people may find they have an upset stomach, a rash, or dry mouth. They may sweat more than usual or feel drowsy but unable to sleep soundly. They may also lose their appetite or become constipated. Men may have difficluty having an erection and may find it difficult to ejaculate. All of these side effects will go away once you stop taking the tablets. ( some of these side effects are permanent)

Patients can occasionalyy feel dizzy, shaky or restless or they may feel faint when they stand up. Very rarely patients may feel fascial, body or muscle spasms or sudden mood changes. ( This is very common, NOT very rare )

Depression is a common illness. At any one time one in 20 people will be suffering from it.
The balance of chemicals in the brain is thought to affect the way we feel. Serotonin is one of these chemicals and also thought to be low in people who are depressed.

It is important that even when you feel better , you continue taking these tablets until your doctor tells you to stop. This will reduce the chance of your depression returning.
( GSK wanted you to take this stuff for a long time)

    PIL 2006

:

Seroxat treats depression and anxiety disorders. Like all medicines it can have unwanted effects.
It is therfore impotant that you and your doctor weigh up the benefits of treatment against the possible unwanted affects, before starting treatment. ( the risks clearly outweigh the so called “benefits”)

If you stop or miss a does you may get withdrawal affects

If you feel restless and like you cant sit or stand still tell your doctor

Possible Side Effects

Likely to affect up to one in 100 people

Unusual bleeding or bruising

Other possible side effect during treatment

Likey to affect up to 1 and 10 people

Feeling Sick
Change in Sex drive and Sexual Function

Likely to affect up to one in 10 people

Increases of cholestoral in the blood
Lack of appetite
Insomnia
Feeling Dizzy or Shaky ( tremors )
Feeling Agitated
Blurred Vision
Yawning, dry mouth
Weight Gain
Feeling Weak
Sweating

Likely to affect up to 1 in 100 people

Bried increase or decrease in blood pressure
Lack of movements, Stiffness , shaking or abnormal movements in the mouth and tongue
Skin rashes
Feeling confused
Hallucinations
Uritary incontinence

Likely to affect up to one in every 1000 people

Abnormal production of breast mik in both men and women
A slow heartbeat
Effects on the liver showing up in blod tests of your liver function
Panic Attacks
Overactive thoughts and behaviours (mania)
Feeling detatched from yourself ( depersonalization)
Feeling anxious
Pain in the joints or muscles

Likely to affect up to 1 in 10,000 people

Liver problems that make the skin or whites of the eyes go yellow
Fluid or water retention which may cause swelling of the arms and legs
Sensitivity to sunlight
Painful erection of the penis that wont go away
Unexpected bleeding .eg. Bleeding gums , blood in the urine or in vomit or the appearance of unexpected
bruises or borken blood vessels
Some patients have developed buzzing, whistling, ringing or other persistent noise in the ears (tinnitus) when they take seroxat

Seroxat is a treatment for adults with depression and anxiety disorders. It is not fully understood how Seroxat and other SSRI’s work but they may help by increaing the level of serotonin in the brain.
Other medicines or psychotherapy can also treat depression or anxiety.
( Seroxat is a lobotomy in pill form)

____________________________________________________________________

Seroxat Link 8 : The Norwegian Adult Suicide Study : 2005


I am going to focus on adult suicidality from Seroxat in this post. It is clear from the information in the previous posts how GSK hoodwinked the regulators for a licence to treat adults with Seroxat from 1991 onwards. They tried desperately to push for a licence to treat children with Seroxat as this would have increased its marketing profile, but they failed miserably.Also we can see from the previous links, that Seroxat clearly posed a danger to children and in the end GSK failed to prove the benefits outweighed the risks. The questions I want to ask here though are concerned with Seroxat use in the adult populations. If Seroxat greatly increases the risk of suicide, aggression and hostility in children with depression and other disorders then why wouldn’t it be the same for adults? No Doctor, psychiatrist or expert has ever been able to explain to me why the effects of Seroxat would be any different between a child or adolescent or an adult taking the drug. Why does GSK maintain that Seroxat is safe for use in the adult populations? when even they themselves admit that it can cause severe and dangerous side effects in children?

Are we to believe GSK’s original Seroxat adult clinical trial data submitted to the regulators to be an accurate and true representation of Efficacy?
Or, considering their history ,should we put our trust in an independently funded study? Well, there was an independent study done on Seroxat in August 2005. It caused a Media Storm at the time because it demonstrated that Seroxat is linked with up to a 7 fold increase in suicide compared to a placebo (sugar pill)… That means you are seven times more likely to kill yourself if you take Seroxat … And they prescribe this drug for Depression! ..
The mind boggles….

From The Times
August 22, 2005
Top-selling drug linked to increased suicide risk
By Nigel Hawkes, Health Edito
r

ONE of Britain’s most widely prescribed antidepressants has been linked to a seven-fold increase in suicide attempts.

An analysis of trials for Seroxat involving more than 1,500 patients found seven suicide attempts among those taking the drug and only one among those taking a placebo. Suicidal thoughts were also commoner among those taking Seroxat (paroxetine), by a factor of three to one.

Almost 2.4 million prescriptions for the drug were issued in England last year.

The data was available even before Seroxat was first licensed in 1990, the Norwegian researchers found. The findings are likely to be seized on by lawyers attempting to win damages against the drug’s manufacturer, GlaxoSmithKline, in the US and in Britain. The mental health charity Mind said the results were “extremely worrying” and confirmed what it had been arguing for years.

“By ignoring what mental health service users themselves have said about the medication and its effects, the drugs regulators may well have caused lives to be lost,” said Sophie Corlett, policy director of the charity.

Campaigners, including Mind, say the drug should be withdrawn from sale, but GSK and the Medicines and Healthcare products Regulatory Agency (MHRA) have defended it, arguing that its benefits outweighed the risks.

However the MHRA has said that too many drugs of this class, SSRIs (selective serotonin re-uptake inhibitors), have been prescribed, and has warned that they should not be given to under-18s.

The MHRA also said that an increase in suicidal thoughts among users of Seroxat “cannot be ruled out.” The new study suggests that such an increase should have been apparent from the beginning.

Sales of paroxetine have fallen sharply in the UK in the past three years after concerns about it were highlighted by the media.

A team led by Ivar Aursnes of the University of Oslo looked at 16 studies in which paroxetine had been compared with placebo, including previously unpublished data.

The trials covered a total of 190 patient-years of use of the drug and the results were published in the journal BMC Medicine.

Ms Corlett of Mind said: “This study would seem to be an extremely worrying addition to growing evidence raising serious concerns over the safety of paroxetine.

“Mind’s own research has revealed that 50 per cent of the people who contacted us to report a reaction to Seroxat had experienced feelings of wanting to self-harm or commit suicide, and 58 per cent of these people said they had not experienced these feelings before they started taking Seroxat.”

GSK said: “We will review this study carefully. However, these conclusions in no way reflect the picture that has been built up about the benefits and risks of paroxetine in adults through an extensive clinical trials programme involving 24,000 patients.”

The MHRA said that while a modest increase in suicidal thoughts and self-harm could not be ruled out for those on SSRIs, there was insufficient evidence to conclude that there is any marked difference between different SSRIs, or between SSRIs and other antidepressants.

The Norwegian group concluded: “The increased suicidal activity seen in children and adolescents on certain antidepressant drugs may well be present in adults. The restrictions in the use of paroxetine in children and adolescents conveyed by regulatory agencies lately should include usage in adults.”

__________________________________________________________________________________________

Drug suicide risk fears renewed

The researchers looked at 1980s studies into Seroxat

Further concerns have been raised about potential suicidal side effects of a commonly used antidepressant.
The drug Seroxat (paroxetine) is already banned from use by adolescents because of an increased risk of suicidal thoughts.

In the journal BMC Medicine, University of Oslo scientists said existing studies indicated these warnings should be extended to adults.

GlaxoSmithKline, which makes the drug, said it had helped millions.

“By ignoring what mental health service users themselves have said about the medication and its effects, the drugs regulators may well have caused lives to be lost “

Sophie Corlett, Mind

Paroxetine is one in a class of drugs known as Selective Serotonin Re-uptake Inhibitors (SSRIs).

In 2003, around 19 million prescriptions for SSRIs were handed out in England for the treatment of depression and anxiety.

Concerns over suicidal side effects for those taking paroxetine were first raised by the BBC’s Panorama programme in 2002.

Last year the Medicines and Healthcare products Regulatory Agency’s (MHRA) Committee on Safety of Medicines concluded that a modest increase in the risk of suicidal thoughts and self-harm for SSRIs could not be ruled out, but the benefits for adults outweighed the risks.

Safety review

The Norwegian researchers, whose study was triggered by a journalist from the Norwegian Broadcasting Corporation working on a medical information programme, analysed the results of 16 trials involving the drug.

The studies were presented to drug regulatory agencies in 1989, prior to the drug being licensed for use by doctors in the early 1990s.

In each, patients had either been given paroxetine or a placebo (dummy pill).

The researchers carried out a statistical analysis of all the results, taking into account the length of time patients were on the drugs.

The studies included 916 patients on paroxetine and 550 patients on placebo.

There were no actual suicides in any of the studies. However, there were seven suicide attempts in the group on paroxetine, and only one in the placebo group.

Writing in BMC Medicine, the team led by Dr Ivar Aursnes, said: “Patients and doctors should be warned that the increased suicidal activity observed in children and adolescents taking certain antidepressant drugs may well be present also in adults.

“We also conclude that the recommendation of restrictions in the use of paroxetine in children and adolescents conveyed by regulatory agencies lately should include usage in adults.”

‘Confirmation’

A spokesman for GlaxoSmithKline: “We take the safety of all our medicines extremely seriously and will, of course, review this study carefully when it becomes available.”

He added: “At this stage, it’s not clear what method the researchers have used to arrive at these numbers or which clinical trials they have selected.

“However, we can say that these conclusions in no way reflect the picture that has been built up about the benefits and risks of paroxetine in adults through an extensive clinical trials programme involving 24,000 patients or through the use of this medicine in tens of millions of people around the world.”

An MHRA spokeswoman said it kept the safety of all SSRIs under close review and all new evidence was carefully reviewed and considered to see if new advice was needed.

Sophie Corlett, director of policy at the mental health charity Mind, said: “This study would seem to be an extremely worrying addition to growing evidence raising serious concerns over the safety of paroxetine.

“It confirms what Mind service users have long been telling us anecdotally.

“By ignoring what mental health service users themselves have said about the medication and its effects, the drugs regulators may well have caused lives to be lost.”

Margaret Edwards, of the mental health charity Sane, said: “Seventy per cent of those being treated with the new anti-depressants respond well, and the risks of suicide from untreated depression must be borne in mind in balancing the risks and benefits.”

______________________________________________


Seroxat Link 6 : Scamming Seroxat : The Players ( Martin Keller)


Around the time of 1998, when GSK were pushing Seroxat for other “disorders” in their bid to steal the crown off Prozac , there was some other interesting stuff going on …
Mostly concerning a pediatric (child ) study , ‘The Infamous Study 329’ ..
Up until 1998 , Seroxat was not licenced for use in children (under 18’s ) , although it was at a doctors discretion and it could be prescribed “off label” to this age group…( and it often was)
But Glaxo desperately wanted to prove that Seroxat worked in this age group (Efficacy) , if they could get a licence to treat childhood disorders with Seroxat , it would increase sales. Their profits were already massive from Seroxat ,( over a billion by 1998 ) but GSK wanted to dominate the market and they stopped at nothing in their pursuit to make Seroxat/Paxil the number one psychotropic drug worldwide.
The only problem was , they were finding it difficult to prove that Seroxat worked for kids, in fact their studies were proving placebos ( sugar pills) to be more effective than Seroxat in under-18’s …
And most disturbing of all, there were indications from Glaxo’s own trials that Seroxat increased the risk of suicide and hostility in Under 18’s, but GSK carried on regardless…

See link :

In the link above, you can access documents relating to study 329 and study 377…
There have been many players in the Seroxat Scam ,One such player was The “Author” of Study 329, an academic psychiatrist called Martin Keller. In the business he is refered to as a “key opinion leader” ..
In other words, his psychiatric and academic voice or opinion is listened to and respected…
But, it seems that Mr Keller didn’t actually write Study 329, he said himself in an interview that he didn’t go through all the raw data… And it seems from interpreting these documents that the study could well have been “ghost written” … So who did Write Study 329? … Was it Glaxo? Was it Glaxo’s marketing team? …

These are excerpts from the Study 329 correspondence ( they were released to the public last year, before that, they were protected under a court order )

RE: PAXll ADOLESCENT DEPRESSION PAPER
Dear Jim:
I am pleased to enclose a small supply of reprints of the paroxetine-imipramine
adolescent depression paper that was recently pub I ished in Journal of the American
Academy of Child and Adolescent Psychiatry. GSK funded the purchase of the
reprints.
A total of 300 went to Marty Keller, who is corresponding author on the
paper, and the balance is being sent to Zach Hawkins for distribution to the
Neuroscience sales force.
Samples are also being sent to Rocco and Neil.
The paper looks excellent and demonstrates the commitment of GSK to the field of
psychiatry.
Thank you for your support.
Sincerely,
~
Sally K. Laden, MS
Associate Editorial Director

February 6, 2001
Martin B. Keller, MD
Department of Psychiatry and Human Behavior
Brown University School of Medicine
345 Blackstone Blvd
Providence, RI 02906
Dear Dr Keller,
We are pleased to enclose all of the materials you will need to resubmit your manuscript
“Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A
Randomized, Controlled Trial” to the Journal of the American Academy of Child and
Adolescent Psychiatry.
Enclosed in this package are the following items:

Two copies of the revised paper with changes highlighted

(submit 1 to the
journal. keep 1 for your files),
Four copies of the revised paper without the highlighting (submit 3 to the
journal, keep 1 for your files)

On behalf of Sally Laden, it has been a pleasure working with you on this project.
Please keep us apprised of the status of this paper at the journal. Thank you and please
do not hesitate to contact us if you have any questions or need additional assistance.

    To: All Sales Representatives Selling Paxil

From : Zachary Hawkins

Paxil Product Management

cc: RVPs
TSMs

Significance of article

“Efficacy of Paroxetine in the Treatment of Adolescent Major
Depression: A Randomized, Controlled Trial”
Martin B. Keller, M.D.
J. AM.ACAD. CHILD ADOLESC. PSYCHIATRY2001
2001, July, Vol. 40:7: 762-772

This “cutting-edge,” landmark study is the first to compare
efficacy of an SSRI and a TCA with placebo in the treatmen1 of
major,depression in adolescents. Paxil demonstrates
REMARKABLE Efficacy and Safety in the treatment of
adolescent depression
.

In conclusion, the findings of this study provide evidence of the
efficacy and safety of Paxil in the treatment of adolescent
depression. Here’s another example of GlaxoSmithKline’ s
commitment to Psychiatry by bringing forth “cutting l~dge”
scientific data. Paxil is truly a REMARKABLE product that
continues to demonstrate efftcacy, even in this understudied
population.

________________________________________________________

So…
GSK finally got what they wanted, an academic interpretation of a clinical trial advocating the use of Seroxat in children…

Only problem was…

Study 329 didn’t actually prove anything …

It was purely GSK marketing gloss…

On the other hand study 377, did prove something…
It proved that Seroxat was no more effective than a sugar pill for the treatment of adolescent/child depression …

Two Studies, Two Results, and a Debate Over a Drug

The two drug trials were known within SmithKline Beecham as Study 329 and Study 377.

Study 329 suggested that the company’s popular drug Paxil might help depressed adolescents. Study 377, completed not long afterward, indicated that Paxil provided no more benefit than a sugar pill in treating depressed young people.

But only the favorable study was widely publicized by Paxil’s maker. The company chose not to discuss publicly the trial with negative results, and those findings came to light only when an outside researcher on the study team decided to disclose them at a medical conference.

Federal regulators in this country are now scrambling to reassess the effectiveness and safety of antidepressants like Paxil, after British regulators touched off a controversy last year by asking drug companies for unpublished data from antidepressant trials. That data suggested that several antidepressants, including Paxil, might give rise to suicidal thoughts in some young users – a potential problem not revealed in any published studies.

Yesterday, the New York State attorney general, Eliot Spitzer, entered the fray by taking the unusual step of suing Paxil’s maker, which is now GlaxoSmithKline. Mr. Spitzer’s suit accuses the company of consumer fraud for not disclosing all of its Paxil data.

Officials of GlaxoSmithKline defend their record, saying they provided all the results of their Paxil clinical trials to the Food and Drug Administration, as required by law. But the stories of Study 329 and Study 377 provide a window into a far broader issue – the fact that the results of many human clinical trials of drugs are often never widely publicized and that, in some cases, doctors may never learn that the trials were even conducted.

These days, most drug trials are sponsored by pharmaceutical companies. And for more than a decade, a growing number of medical experts have been urging drug makers to release more trial data and to create uniform means of disclosing results through central registries, so that policy makers and doctors can easily learn the results. Those advocates argue that such central databases are necessary because drug companies, as well as medical journals and researchers, tend to spotlight only trials that show positive results

The fates of Study 329 and Study 377 appear to underscore that point. Both tests were conducted during the mid-1990’s at various hospitals and medical centers – Study 329 at facilities in the United States and Study 377 at test centers outside of this country, including Canada, Mexico, Europe, South Africa and the United Arab Emirates.

Study 329, with its potentially positive findings for Paxil, was completed first. Its results were presented beginning in 1998 at several meetings of medical professionals. Meanwhile, a report of the trial, which was led by Dr. Martin B. Keller, a department chairman at Brown University Medical School, was submitted to a medical journal for publication, a process that subjects a study to peer review by scientists not involved in the trial.

Dr. Keller declined to be interviewed for this article. But Dr. Neil Ryan, a professor at the University of Pittsburgh, who was also involved, said he believed that the study was rejected by some journals before The Journal of the Academy of Child and Adolescent Psychiatry accepted it for publication in 2001.

In the case of Study 377, the one with negative findings, there were no press releases or publications. And without the action of Dr. Milin and a Canadian colleague, Dr. Jovan Simeon, the study’s findings might have been seen only by regulators and a few researchers.

The writer of “clinical psychiatry a closer look” wrote a poignant artice about the the Study 329 shambles… Here are some excerpts …

Tuesday, January 30, 2007
Keller, Bad Science, and Seroxat/Paxil

I will focus on Dr. Martin Keller and some seriously poor science in this post. Panorama did an excellent job of profiling Keller’s role in helping to promote paroxetine (known as Paxil in the USA and Seroxat in the UK). Note this is a lengthy post and that the bold section headings should help you find your way.

Who is Martin Keller? He is chair of psychiatry at Brown University. According to his curriculum vita, he has over 300 scientific publications. People take his opinions seriously. He is what is known as a key opinion leader or thought leader in academia and by the drug industry. What does that mean? Well, on videotape (see the Panorama episode from 1-29-07), Keller said:

You’re respected for being an honorable person and therefore when you give an opinion about something, people tend to listen and say – These individuals gave their opinions; it’s worth considering.
Keller and Study 329: GlaxoSmithKline conducted a study, numbered 329, in which it examined the efficacy and safety of paroxetine versus placebo in the treatment of adolescent depression. Keller was the lead author on the article (J American Academy of Child and Adolescent Psychiatry, 2001, 762-772) which appeared regarding the results of this study.

Text of Article vs. the Actual Data: We’re going to now examine what the text of the article said versus what the data from the study said.

Article: Paroxetine is generally well-tolerated and effective for major depression in adolescents (p. 762).

Data on effectiveness: On the primary outcome variables (Hamilton Rating Scale for Depression [HAM-D] mean change and HAM-D final score What exactly were emotional lability and hostility? To quote James McCafferty, a GSK employee who helped work on Study 329, the term emotional lability was catch all term for ‘suicidal ideation and gestures’. The hostility term captures behavioral problems, most related to parental and school confrontations.” According to Dr. David Healy, who certainly has much inside knowledge of raw data and company documents (background here), hostility counted for “homicidal acts, homicidal ideation and aggressive events.”

Suicidality is now lability and overt aggression is now hostility. Sounds much nicer that way.

Conveniently defining depression: On page 770 of the study report, the authors opined that “…our study demonstrates that treatment with paroxetine results in clinically relevant improvement in depression scores.” The only measures that showed an advantage for paroxetine were either based on some arbitrary cutoff (and the researchers could of course opt for whatever cutoff yielded the results they wanted) or were not actually valid measures of depression. The only measures that were significant were either a global measure of improvement, which paints an optimistic view of treatment outcome, or were cherry-picked single items from longer questionnaires.

Also, think about the following for a moment. A single question on any questionnaire or interview is obviously not going to broadly cover symptoms of depression. A single question cannot cover the many facets of depression. Implying that a single question on an interview which shows an advantage for paroxetine shows that paroxetine is superior in treating depression is utterly invalid. Such logic is akin to finding that a patient with the flu reports coughing less often on a medication compared to placebo, so the medication is then declared superior to placebo for managing flu despite the medication not working better on any of the many other symptoms that comprise influenza.

Whitewashing safety data: It gets even more bizarre. Remember those 10 people who had serious adverse psychiatric events while taking paroxetine? Well, the researchers concluded that none of the adverse psychiatric events were caused by paroxetine. Interestingly, the one person who became “labile” on placebo – that event was attributed to placebo.
In this magical study, a drug cannot make you suicidal but a placebo can. In a later document, Keller and colleagues said that “acute psychosocial stressors, medication noncompliance, and/or untreated comorbid disorders were judged by the investigators to account for the adverse effects in all 10 patients.” This sounds to me as if the investigators had concluded beforehand that paroxetine is incapable of making participants worse and they just had to drum up some other explanation as to why these serious events were occurring. David Healy has also discussed this fallacious assumption that drugs cannot cause harm.

Did Keller Know the Study Data? I’ll paraphrase briefly from Panorama, which had a video of Keller discussing the study and his role in examining and analyzing its data. He said he had reviewed data analytic tables, but then he mentioned soon after that on some printouts there were “item numbers and variable numbers and they don’t even have words on them – I tend not to look at those. I do better with words than symbols. [emphasis mine].”

Ghosted: According to Panorama (and documents I’ve obtained), the paper was written by a ghostwriter. Keller’s response to the ghostwriter after he saw the paper? “You did a superb job with this. Thank you very much. It is excellent. Enclosed are some rather minor changes from me, Neal, and Mike. [emphasis mine].” And let’s remember that Keller apparently did not wish to bother with looking at numbers. It would also appear that he did not want to bother much with the words based upon those numbers.

Third Party Technique: This is a tried and true trick – get several leading academics to stamp their names on a study manuscript and suddenly it appears like the study was closely supervised in every aspect, from data collection to data analysis, to study writeup, by independent academics. Thus, it is not GlaxoSmithKline telling you that their product is great, it is “independent researchers” from such bastions of academia as Brown University, the University of Pittsburgh, and University of Texas Southwester Medical Center and the University of Texas Medical Branch at Galveston which are stamping approval of the product. More on this in future posts.

Keller’s Background… It is relatively well-known that Keller makes much money from his consulting and research arrangements with drug companies. In fact, several years ago, it was documented that Keller pulled in over $500,000 in a single year through these lucrative deals. When looking at how he stuck his name on a study he did not write, endorsing conclusions that were clearly far from the actual study data, can one seriously believe that Keller operated as an independent researcher? Can you believe that this is an isolated incident?

See, for example, Keller’s involvement in a study examining the effects of Risperdal (risperidone) for the treatment of depression. This study was presented a number of times, and he never appeared as an author of any of the presentations. Yet when the study was published, his name appeared as an author. The real kicker was that he allegedly helped to design the study, according to the published article. If he had played a major role in the study, he would have been acknowledged earlier (via being listed as a presentation author), so he apparently helped design the study after it was completed, which is obviously a major feat! The whole story is here. Why put his name on the paper? So that readers would believe more strongly in the study due to his big name status.

In addition, Keller wrote about how Effexor reduces episodes of depression in the long-term though he clearly misinterpreted the study’s findings. To be fair, many other researchers have made the same mistake in believing that SSRI’s reduce depression. To quote an earlier post:

In other words, because SSRIs and similar drugs (e.g., Effexor) have withdrawal symptoms that sometimes lead to depression, it looks like they are effective in preventing depression because people often get worse shortly after stopping their medication. The drug companies (Wyeth, in the case of Effexor) would like you to believe that this means antidepressants protect you from re-experiencing depression once you get better, that they are a good long-term treatment. A more accurate statement is that antidepressants protect you from their own substantial withdrawal symptoms until you stop taking them.
Again, Keller is way off from the study data.

Keller on Camera: Keller’s response to being asked about the increased suicidality among participants taking paroxetine in Study 329 was interesting:

None of these attempts led to suicide and very few of them led to hospitalization.

Well then I suppose a huge increase in suicidal thoughts and gestures is okay, then? This is the commentary of an “opinion leader” – if statements such as the above shape opinions among practicing psychiatrists, then we really are in trouble.

Next: Well, consider this post just the start regarding Paxil/Seroxat. The way the data were pimped by GSK merits more discussion as does more discussion of allegedly detached academics and their role in this debacle.

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Seroxat Link 5 : 1998 , Seroxat Holocaust , The Second Wave


So far , Through the links I have provided on this blog, we can see where Seroxat came from, How GSK unscrupulously hoodwinked it passed the regulators (MHRA and FDA) and obtained a market to promote what was originally classified as a “hypnotic” chemical as an “antidepressant” treatment… Seroxat was then released to an unsuspecting and trusting public in 1991 , I call this The first wave , because it seems that from this period until 1998 , GSK were testing the waters with Seroxat , gathering data on how it would perform …How much could they get away with?

But it was in 1998, (when Seroxat was relicenced )that GSK Stepped up a gear, GSK went on a marketing Blitz … A triumph of Marketing over Science.. With the help of devious sales tactics, In 1998 , GSK turned Seroxat into a blockbuster…

Here is how they went about it :

Seroxat : For Shyness

New pill to beat shyness
Sunday Mirror, Oct 4, 1998

A PILL to combat shyness is being launched this week and will be available on the NHS.

The drug, which could relieve the symptoms of up to three million chronically- shy people in Britain, is reported to improve the condition within a week in some cases.

Seroxat, which was originally licensed to treat depression, has now been given the go-ahead to fight shyness and “social phobias”.

The drug works by increasing the level of seratonin in the brain, and could cost the NHS up to pounds 700 million a year if all the country’s shy people took it.

Thursday, 23 July, 1998, 08:56 GMT 09:56 UK
Shy? Try taking a pill

Social wallflowers could be transformed into outgoing party animals with the help of a new drug.
SmithKline Beecham claims its anti-depression drug Seroxat, launched in the UK in 1992, has been shown in tests to cure ‘social phobia’.

It has applied to the US Food and Drug Administration for a licence to use the drug, now prescribed for panic attacks, for people diagnosed as having acute shyness.

The media has climbed onto the Seroxat bandwagon, hailing it as the big new thing in social drugs after anti-impotence pill Viagra.

They say Seroxat will help shy people get to the point where they might need Viagra.

    The downside is that Seroxat can reduce sexual drive and function.

Serotonin

The drug boosts the level of serotonin in the brain – the hormone which controls people’s moods.

It is already a major success at treating depression and its sales have risen by 23% in the last year.

It now accounts for one quarter of US anti-depressant drug sales and it was the fastest selling anti-depressant drug in the UK in the mid-1990s. In 1996, UK sales grew by 50%.

But if it gets approval to be used to treat acute shyness, sales are likely to soar.

    A spokesman for SmithKline Beecham said shyness was ‘ a serious condition’ and that only those who had acute problems would be prescribed the drug by doctors.

“It would be used for the sort of people who would have to run out of a crowded room. The underlying problem is usually extreme anxiety,” he said.

-SMITHKLINE BEECHAM: SmithKline Beecham’s Seroxat/ Paxil approved in UK to treat social anxiety disorder.

PHILADELPHIA, PA — Seroxat/Paxil (paroxetine HCl) has been approved for the treatment of social anxiety disorder in the United Kingdom, SmithKline Beecham announced today. It is the first selective serotonin re-uptake inhibitor (SSRI) to be approved for this severely debilitating and little known anxiety disorder. Seroxat/Paxil is currently under review for this indication throughout

Pill to melt shyness

Most people call it extreme shyness. According to some experts, up to eleven per cent of people in Ireland suffer from it. They prefer to call extreme shyness “social phobia” and they say that people who suffer from it experience unimaginable torment and isolation.

Now doctors believe Seroxat, a pill to counteract depression, can also help these social phobics or people who are, literally, painfully shy.

Now, new research in Britain which reveals that the anti-depressant drug Seroxat successfully treats the condition has brought the plight of social phobics into the public mind for the first time.

On 9th January 1998, in the face of mounting adverse reports from users and GPs, Seroxat was re-licensed for a wider range of symptoms including depression accompanied with anxiety, obsessive compulsive disorder and panic disorder. Off label prescription included pre-menstrual tension and irritable bowel syndrome. This wider remit increased sales dramatically and for the first time people who had never been depressed or suicidal were being prescribed Seroxat. Unbeknown to them, they were exposed to the additional risk of dependency syndrome and a raised risk of suicide. No longer could depression, suicidal thoughts and acts suffered by these people be attributed to a relapse of their depressive illness.

Revealed: secret plan to push’happy’ pills

Jamie Doward and Robin McKie
Sunday November 7, 2004
The Observer

Britain’s largest drug company drew up a secret plan to double sales of the controversial anti-depressant Seroxat by marketing it as a cure for a raft of less serious mental conditions,

The contents of the 250-page document have alarmed health campaigners who accuse the firm, GlaxoSmithKline (GSK), of putting profit before the therapeutic needs of patients by attempting to broaden the market for the drug which has been linked to a spate of suicides.

The internal report carries a section which outlines how GSK planned to double sales of ‘selective serotonin reuptake inhibitors (SSRI)’ – the industry term for anti-depressants – by winning the marketing war against Seroxat’s chief rival, Prozac, manufacured by Eli Lilly.

Written in 1998 and subsequently updated in following years, the section is entitled: ‘Towards the second billion – all SSRIs are not the same’ and discusses strategies to see off the threat posed by Prozac.

    The document outlined how GSK intended to market Seroxat for a range of conditions other than clinical depression. Chief among these was a condition the company identified as social anxiety disorder, although other forms of anxiety were also discussed internally.

‘What this document makes clear is that a number of different forms of anxiety were being targeted in a systematic way. The thrust was to move sales beyond the $1 billion to $2 billion mark by pushing it to people who were not clinically depressed,’ said Professor David Healy, a psycho-pharmacologist at Cardiff University, who has given evidence to the House of Commons Health Select Committee.

Richard Brook, chief executive of Mind, the mental health charity which submitted the document to the committee, told the MPs it was ‘all about developing new conditions for that drug and demolishing the arguments of other competitors about why their drug was not any good’.

In addition the document shows GSK made a great virtue of the fact that Seroxat had a relatively short ‘half-life’ compared with Prozac, an argument which has subsequently proven deeply controversial.

A half-life is the scientific term for how long it takes for the concentration of a drug to drop by 50 per cent in a patient’s bloodstream. The company suggested Seroxat’s short half-life meant patients could come on and off the drug easily, compared with those on Prozac, even to the extent that they could take ‘treatment holidays’. ‘There was an argument that a short half life was really good news,’ Brook said.

But five years later, Seroxat has withdrawal issues. It’s the short half life that causes the problems. The substances get into the body so quickly it causes some sort of dependency reaction. So one of the things the company was saying was a benefit was actually a problem.’

In its submission to the parliamentary committee Mind said the original trial data submitted to the UK regulators by GSK showed the claim was at best ‘naive and at worst seriously mislead ing’. It added that ‘the Seroxat file is highly illustrative of using marketing information as facts’.

Concerns about the addictive properties of Seroxat saw the government ban its prescription to people under the age of 18 last year. This followed a review which found children taking it were more likely to self-harm or commit suicide.

A spokesman for GSK said Seroxat could be marketed at new conditions only after stringent testing. ‘Medical authorities around the world have required that GSK study each condition separately in order to prove benefit in each condition specifically.’

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In 1998 , GSK also released a sales memo to their Paxil ( Seroxat ) selling team …
The memo speaks for itself…

For more GSK / Seroxat internal memos and documents see link :

http://abcnews.go.com/Health/story?id=311956&page=1

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Seroxat Link 4 : Seroxat Holocaust : The First Wave : 1991


The previous link was in regard to the FDA approval of Seroxat … (Paxil in the US) in 1993
But… It was actually first Licensed in the UK in 1991 (which undoubtedly swayed and influenced the FDA’s decision to grant it a licence too)…(Seroxat was then re-licensed by the MHRA in 1998.. )

Seroxat Link 3 : The Yugoslavia Trials : GSK & Paroxetine


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Ok, so we know that Seroxat (chemical : paroxetine ) first emerged from the labs at Ferossan , and we know that B.I. (boehringer-ingelheim) originally filed paroxetine in the class of “hypnotics”..

So how did GSK get it passed by the drug Regulators as an anti-depressant?…

This is how…. (for the full transcript of Breggins Article , click on the text )

From 1980-1991, approximately 5000 patients were tested on Paxil during SKB’s clinical trials.Eighty-three (83) different Paxil trials were conducted.Various time periods were involved in the individual trials.Many patients were tested for only a month or 6 weeks.Some were tested longer, including approximately 400 who were in trials longer than a year.SKB pulled out all the stops to ensure the trials were successful.Only two (2) positive trials are required for FDA market approval.By any reasonable person’s perspective, Paxil’s track record in the clinical trials was poor.After a decade of juggling data in the 83 different trials, SKB was finally able to cite four (4) “positive” trials and three (3) “supportive” trials to justify Paxil’s approval.Dropouts in most trials were rampant.Most of the dropouts occurred because Paxil caused adverse experiences, and the victims wanted nothing more to do with the drug.

Paxil’s clinical trials were a statistical sham.Rather than deal with real numbers, SKB created a fraudulent measuring standard called “patient years” (or “patient exposure years”).The need for “patient years” became obvious in the 1980’s.It was obvious in the late 1980’s and into the 1990’s that Paxil clinical patients were attempting suicide and suffering “adverse experiences” at an alarmingly high rate.Moreover, as indicated above, hundreds of Paxil volunteers dropped out because they could not tolerate the drug.The dropout rate was 20%.Fifty-eight (58) patients alone attempted suicide after they were given Paxil.Hundreds of additional Paxil patients suffered adverse experiences caused by the drug.In 1991, SKB “ran the numbers” and discovered the absolutely horrible Paxil record.The 58 attempted suicides out of the patient base constituted a suicide rate of 0.77% in real numbers.Under clinical standards, a rate of 1% is considered a “frequent” occurrence.On those numbers, Paxil patients approached a “frequent” suicide rate.This was a far greater suicide rate than “placebo” or the other active drug being tested on the patient population.To avoid a company disaster on the Paxil project, SKB had to change the rules, and shift to the “patient years” sham.

22.The “patient years” standard is a sham by anyone’s common sense.It works like this.Assume 366 patients are selected at random to test Paxil.Three hundred and sixty five (365) patients take Paxil and suffer horribly the first day–immediately quitting the test.These patients are called, not surprisingly, “losers.”The 366th patient, however, tolerates Paxil quite well, and even improves on the drug, staying in one or more trials for a full year.This patient is a “winner” by SKB standards.Like a champion race horse, this “winner” is entered in all the sweepstake trials for Paxil–and these trials are intentionally programmed to be long.Knowing they have a champion race horse, SKB racks up “points.”By anyone’s common sense standards, 365 failures out of 366 attempts would render the drug a dismal failure.But not so under “patient years.”Under patient years, the one Paxil patient who tolerated the drug for one year counts the same as the 365 patients who couldn’t tolerate the drug and dropped out the first day.The “score” in this example is “one patient year” for each side.Not surprisingly, the mathematicians who go along with this voodoo math are subordinate to the physicians and clinicians in the corporate chain of command, and the physicians at the top of the FDA chain of command.

.
In Paxil’s clinical trials, SKB ultimately achieved positive results–as it were–because of emphasis on “subjective” testing data.Objective data is very scientific.Subjective data is less scientific.The latter requires more stringent controls to be applied scientifically.Subjective data is subject to the biases, opinions, and prejudices of the person(s) collecting the data.SKB’s subjective data to justify Paxil’s approval was obtained both from physicians, principal investigators (“PI”) (most of whom were physicians) and from patients.The physicians and PI’s were compensated handsomely by SKB for their participation in the trials.On information and belief, plaintiffs allege these individuals were hired only after appropriate screening to ensure they were friendly to the drug industry and SKB.

.It was in mid 1992 that Dr. Laughren was directed by the FDA to be the staff point person for the October 5, 1992 Paxil committee hearing.Dr. Laughren had earlier concluded he would recommend Paxil’s approval.Dr. Laughren was also getting promoted and had only recently assumed the higher position.He was being assigned to take over the position occupied by the FDA official who had telephoned SKB on the PR nature of the Prozac problem.Dr. Laughren was taking over the higher position very late in the game insofar as Paxil’s application was concerned.The earlier incumbent–as described–had already taken a position favoring Paxil’s approval, and was not modest in voicing full support for SSRI’s.It would have been highly unusual for the FDA to place in that position an individual who would upset the apple cart and refute what his/her predecessor had committed to on the Paxil decision–and of course that didn’t happen.Dr. Laughren fell in line with his predecessor and validated all of his predecessor’s findings.In preparation for the upcoming October 5, 1992 committee proceedings, Dr. Laughren wished to be “hands on” before committee members.His wished to make it appear that the FDA staff was totally in command of their domain.Here, however, is where the FDA regulatory system breaks down–and was broken in this instance.It is where, essentially, the government bureaucrat depended on the “regulated” in order to look good in the job and get through a particular project–and that’s what happened here.Both players–FDA staff and SKB–recognized they were dependent on each other to look good before the committee.Like the telephone tipoff on the suicide issue, this was a poor environment for checks and balances, or fostering effective FDA regulation on behalf of public safety.For several weeks leading up to October 5, 1992, Dr. Laughren depended on SKB to get up to speed for his expected presentation before the committee.This was notwithstanding that FDA had been provided all of Paxil’s trial documentation as the clinical trials had progressed throughout the previous decade.As Dr. Laughren was preparing for the committee hearing, he made several urgent fax appeals to SKB headquarters to help him prepare his presentation.He was not modest.He asked numerous questions.He asked for numerous, individualized research scenarios.Some were provided immediately from SKB’s computer.Others had to be specially gathered by SKB and forwarded later.To facilitate Dr. Laughren’s support for their product, SKB promptly and fully complied with all of his requests.These SKB and FDA principals operated on a “first name” basis in their fax exchanges.SKB officials were so friendly with Dr. Laughren, they addressed him as “Tom” in front of the committee podium.

When the FDA committee convened in Rockville, Maryland, on October 5, 1992, the FDA staff made their presentation first.SKB’s presentation followed.Dr. Laughren’s presentation was lengthy, and essentially constituted the FDA staff’s position on Paxil.In his overview to the committee, Dr. Laughren addressed many Paxil issues.Knowing the six (6) voting members would be interested in the “withdrawal” issue, Dr. Laughren felt obligated to explain to the committee FDA’s understanding on the Yugoslavia trial.That was that the Paxil withdrawal issue was not formally studied during the tests.Laughren told the committee in regard to the Yugoslavia trial:”There was no systematic effort really to look at the withdrawal syndrome, but in looking at the patients coming off of…(Paxil)…in the clinical trials, there was no strong suggestion of a withdrawal syndrome.”That was strange language coming from a top FDA official commenting on clinical trials.Proper science and clinical analysis do not permit a “strong suggestion” of anything without scientifically imposed controls to justify such a conclusion.

.At that juncture, SKB’s plan for the committee was proceeding smoothly.The FDA was in their corner, and the FDA staff had told the committee exactly what SKB had hoped they would.Then in the afternoon it was SKB’s turn to address the committee.SKB was not content to rest on Dr. Laughren’s commentary regarding the Yugoslavia study.SKB boldly went to the next level.SKB asserted to the committee that SKB had studied “whether or not there is a discontinuation syndrome in patients who are abruptly discontinued from Paxil.”The SKB representative continued:”To end with a brief discussion of whether or not there is a clear withdrawal syndrome, we have pulled upon the …(Yugoslavia trial)…”Then, SKB made an outrageous and categorical falsehood.The SKB representative told the committee SKB in the Yugoslavia trial attempted to “systematically assess a discontinuation syndrome.”This statement was in direct contradiction of Dr. Laughren’s earlier statement in the day that “There was no systematic effort really to look at the withdrawal syndrome.”Having refuted the FDA representation that there were no “systematic” tests on Paxil withdrawal, SKB then further claimed the tests were successful in that regard.The SKB representative told the committee they examined the data on the Phase II placebo group and that “few numbers of patients experienced any adverse event after being randomized off…(Paxil)…into the placebo group and the percentages are certainly very small.”What SKB failed to add was that no “adverse events” were reported on the placebo group because the eighteen (18) placebo victims’ symptoms were reported by SKB to have been “relapse” symptoms.Given the high bar established by SKB for relapse, the 18 placebo victims constituted a staggeringly high 45% of the placebo group.Had a reasonable clinical standard for “relapse” been set, it is quite possible 75% or 90% an or even higher casualty rate would have been recorded.

.Then a most startling and telling exchange occurred before the committee.The SKB proclamation that “systematic” withdrawal testing had been accomplished in the Yugoslavia trial caught the FDA staff representative, Dr. Laughren, completely off guard.Hearing the SKB representative directly contradict him on “systematic” withdrawal testing, and further hearing that placebo patients suffered no adverse effects after being taken off Paxil, Dr. Laughren interrupted the SKB speaker.From his perspective sitting in the audience, Dr. Laughren understood there were “crossed signals” before the committee between the FDA staff and SKB, and that the discrepancy required immediate correction.Dr. Laughren additionally understood there was now a gap in the testimony.Dr. Laughren understood the placebo group’s statistics meant nothing without comparison to the Paxil group.He then yelled up to the podium to the SKB representative, and the following exchange occurred:
Laughren:”Unfortunately you did not contrast…(the placebo group)…with the rates…(of adverse experiences)…in the patients who continued on…(Paxil)…”
SKB:”Right.I know the point you are going to raise, that it really does not look that different…”
Laughren:”That was my impression.”
SKB:”…from what you saw in the…(Paxil)…group, and that is a well founded point.So we very much agree with your earlier conclusion that there is no clear withdrawal syndrome but this was our attempt to try and investigate it in somewhat of a controlled fashion.”
In effect, SKB had just pulled off a coup.SKB had successfully and deceitfully maneuvered Dr. Laughren into making the case before the committee that withdrawal tests were conducted, and they proved Paxil “clean” on the withdrawal issue.SKB got Dr. Laughren to do their heavy lifting before the committee on a subject the FDA official had no personal knowledge of.SKB simply stepped aside and put icing on the cake with a polite “we very much agree with…(Dr. Laughren’s)…earlier conclusion that there is no clear…(Paxil)…withdrawal syndrome.”

.SKB’s tactic to skirt the withdrawal issue at the committee hearing was thus successful.After representation to them that Paxil had been systematically tested for withdrawal and that the tests were successful, the committee voted to approve Paxil.

seroxat withdrawal

Seroxat link 2 : NeuroSearch/Buus Lassen : The Birth Of Seroxat


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Where did Seroxat Come from ?..
Who created it?..
What can we learn from its origins?…

In the middle of the 70s, reports of a new breed of antidepressant began emerging from small laboratories in Scandinavia. It was found that certain drugs like reserpine, a popular tranquillizer and anti-hypertensive treatment that depleted serotonin levels had an interesting side effect: it produced depression-like symptoms.

At the Danish firm of Ferrosan, the head of research was a man called Jørgen Buus Lassen, who supported the theory that the specific enhancement of serotonin might lift a depressive mood. He tested about 100 compounds before deciding on one that became known as paroxetine. ‘We did all the clinical trials,’ he says today from his office in Glostrup, near Copenhagen, ‘and what created most excitement among our scientists was that in some trials we saw that some patients who had been totally hopeless on the existing drugs and not at all responsive to treatment, were gradually becoming better and better. Some who had been unable to work for several years and had been in and out of psychiatric hospitals gradually came into normal life again.’

Dr Jorgen Buus Lassen wrote the first scientific paper on paroxetine in 1975, in the paper he was frank about the drugs limitations.’It didn’t work with all patients,’ he remembers. ‘In most studies we could just show that we had about the same efficacy as the older tricyclic antidepressants. We didn’t see a better effect, but we saw fewer side effects [mainly nausea].’

 

 

Dr. Jørgen Buus Lassen (Danish) received his DVM from the Royal School of Veterinary and Agriculture Science in Copenhagen. Dr. Lassen is co-founder of NeuroSearch A/S and has been the President and CEO of NeuroSearch since May 1989. He has more than 25 years’ experience within neuropharmacology and has authored or co-authored more than 30 publications, including the first paper published with respect to Paroxetin (Paxil, Seroxat), an antidepressant. From 1980 to 1988, Dr. Lassen served as Managing Director of Ferrosan A/S` research and development division, where Dr. Lassen was responsible for the expansion of all pre-clinical and clinical activities. He is chairman of the boards of NsGene A/S and Gudme Raaschou Healthcare Invest A/S and member of the boards of Bavarian Nordic A/S, Neurosearch A/S and NicOx S.A. Board member of Pharmexa since 1997. Reference is made to Pharmexa’s address.

Dr Jorgen Buus Lassen is also connected with NeuroSearch, he is the President and CEO of Neurosearch

 

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http://www.neurosearch.com/

Which is affiliated with GSK…

 

NeuroSearch and GlaxoSmithKline form strategic RD alliance

19 December 2003 – Announcement

PDF version

NeuroSearch and GlaxoSmithKline (GSK) today announced a five-year research and development alliance. The alliance comprises a number of research programmes within ion channels and the treatment of diseases of the central nervous system (CNS) including depression, anxiety, and schizophrenia. The new alliance combines NeuroSearch’s innovative research and development, and strong technology platform with GSK’s research, development, and commercial strength.

The option agreement gives GSK access to new drug candidates from NeuroSearch’s research and development within the defined area. This includes the Phase II triple monoamine re-uptake inhibitor NS2359, the Endovion programme and several other research programmes. The existing collaboration with GSK in depression disorders is integrated in the new agreement.

President CEO Jørgen Buus Lassen of NeuroSearch says, I am pleased that we were able to conclude this important strategic alliance with GSK as our two companies have had a well-functioning and trustful partnership within depression research for three years. I have a strong expectation that this extended partnership will be a major success for both companies.

http://findarticles.com/p/articles/mi_hb033/is_200301/ai_hibm1G197351003

GlaxoSmithKline (www.gsk.com) and the Danish company NeuroSearch (www.neurosearch.com) will collaborate to discover and develop “triple-action” monoamine reuptake inhibitors to treat depression and other mood disorders. (Development Updates).(depression and other mood disorders)(Brief Article)

For more info on Ferossan , Buus Lassen and the Origins of Paroxetine and how it came to be unleashed on an unsuspecting public see link on Seroxat link 1 (hypnotic narcotic) .. A very informative post by Rob Robinson on Paxil Progress…

www.paxilprogress.org/forums/showthread.php?t=11984&highlight=paroxetine+hypnotic

 

Seroxat Link 1 : The Hypnotic Narcotic


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What exactly is in the chemical compound of Seroxat which makes it so Addictive?…
Why do we call it a “Hypnotic Narcotic”?..
Why does it induce such horrific withdrawls?..

We believe the “hypnotic” element to be a very important part of the Seroxat Chain.

Seroxat/Paxil ( chemical name paroxetine) was first registered by a german drug company Boehrinnger Ingelheim as a ” hypnotic drug for human use”.So, effectively Seroxat is not and never has been an SSRI or an anti-depressant at all.It is in fact in the class of “hypnotics”. Strange how after been accquired by GSK it would then go on to be approved by drug regulatory bodies such as the American FDA and UK’s MHRA for depression, post traumatic stress disorder , generalised anxiety, panic disorder and OCD. Strange how it mysteriously moved from one category to another.

How could a Hypnotic drug be useful for these “disorders”?
How can a drug company get away with marketing a “hypnotic” drug for a wide variation of “psychiatric disorders”? How close to a narcotic is a hypnotic?

Some answers and some more questions can be found here :

http://www.paxilprogress.org/forums/showthread.php?t=11984&highlight=paroxetine+hypnotic

Paxil Us Patent ( Registered as a Hypnotic Drug For Human Use )

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A Seroxat Side effect called “Somnolence” Occurs in 23% of patients in a Clinical Trail Submited to the FDA in 2003 ( )
Somnolence is also a major characteristic of Hypnotic drugs…
And it is also a major characteristic of Narcotic drugs…

Hypnotic drugs are a class of drugs that induce sleep (which differentiates them from the sedative category), used in the treatment of severe insomnia and in surgical anesthesia. Often the treatment of insomnia will not begin with drugs at all; however, as many, though not all hypnotic drugs are habit forming.

 

http://en.wikipedia.org/wiki/Hypnotic

signs and symptoms of narcotic/opioid overdose include the following: euphoria, arousable somnolence (“nodding”), nausea, pinpoint pupils (except with Pethidine/Meperidine [Demerol]), hypoxia, or in combination with other types of drugs, coma, and seizures.

Could it be that Seroxat should have been classed as a “Hypnotic/Narcotic”… ?

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