By Ed Silverman // June 20th, 2008 // 7:14 am
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 :
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 :
“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 :
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”.
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
There was also a transcript of this meeting which was made available
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
Side Effects: A Prosecutor, a Whistleblower, and A Bestselling Antidepressant on Trial
“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) :
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 :
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.
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.
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.
Japan sees an increase in suicide among Paxil users
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.
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
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
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.