Dr Karen Wagner, "no financial relationships with pharmaceutical companies"
You'd have to be from the planet Zog if you didn't know who Karen Wagner was.
Her name is synonymous with antidepressant pediatric studies. She added her name to the Paxil 329 ghostwritten paper without actually looking at the raw data [which showed an increased rate of suicidal thoughts in kids taking Paxil] - The result of that piece of Pharmafia fraud told millions of prescribing physicians that Paxil was safe to use in children and adolescents...when in actual fact it wasn't.
Wagner has been relentless to disprove those who believe antidepressant use in kids is wrong. She sees no problem with it...despite overwhelming evidence that shows just how dangerous antidepressant use in kids can be.
An article published in Clinical Psychiatry News a couple of days ago shows Wagner, once again, promoting the use of SSRi medication in children and adolescents.
Wagner was present at a psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry where she claimed that "...60% of youngsters will respond favorably to their first antidepressant medication – generally a selective serotonin reuptake inhibitor (SSRI)"
Wagner also went on to claim that Switching to a different antidepressant will help about 50% of those who don’t respond. But adding psychotherapy will grab about 10% more – bringing the total response rate up to around 70%". She was referring to a 2008 study, TORDIA (Treatment of Resistant Depression in Adolescents)
So, Wagner hits the stage at these types of events, she's a key opinion leader, in other words, those employed in the same field as her look up to her, respect her, hang on to her every word. She is the Geldof of the pop world, pushing her message at every given opportunity. Quite why she sticks her middle finger up at evidence that shows kids kill themselves whilst on these drugs kind of alarms me.
So, is Wagner on a mission to help depressed children and teens, does she genuinely care about this population or are there more sinister undertones?
It would help if she and the article published in Clinical Psychiatry News was actually more transparent about her relationship and financial ties to the pharmaceutical industry [Pharmafia].
Upon reading the article I had to do a double take at the end... "Dr. Wagner has no financial relationships with pharmaceutical companies."
Um, excuse me?
Was this a line Wagner told the writer of the article, Michele Sullivan, or has Sullivan just not done her homework?
The content of the article doesn't interest me. Anything that comes out of the mouth of Karen Wagner should be carefully scrutinised given her links to the Paxil 329 study...and other studies for that matter.
What interests me is the startling revelation that Wagner has "no financial relationships with pharmaceutical companies."
Let's just dispel this shoddy piece of journalism.
An article from Alicia Mundy in 2009 [Wall Street Journal] shows that Wagner didn't report some $150,000 in funds such as speakers fees received from GlaxoSmithKline, she also failed to report a trip to Paris.
In fact the then Iowa Republican, Senator Charles Grassley, claimed that the amount Wagner didn't report may have been as high as $230,000.
Wagner, who at the time was working out of the University of Texas, had the backing of her peers who told Grassley they were never aware of any discrepancies regarding Dr. Wagner’s reporting of income from GSK.
Wait a minute... Let's just go back to the recent article in the Clinical Psychiatry News. "Dr. Wagner has no financial relationships with pharmaceutical companies."
Maybe someone should inform Michele Sullivan that she has dropped a clanger in her article.
Sullivan should have also noted that Wagner, according to documents disclosed by GSK under court order, was paid to deliver lectures promoting the use of Paxil for depressed kids and teens to both GSK’s sales reps and doctors.
At a training session for the sales reps, Wagner told the sales force that depression in adolescents was a lethal disorder that, if untreated, could lead to suicide and linger into adulthood. Wagner told the sales reps that the study in question demonstrated that Paxil was both safe and effective treatment for adolescent depression, and that they could expect the positive results for the first of the Paxil studies to be published in early 2000. [Complaint, United States v. GlaxoSmithKline, et al. (“GSK Complaint”), para 52, and Ex. 3 thereto]
Wagner also appeared at no less than 5 “Paxil forum” meetings, which were resort holidays sponsored by GSK for high-prescribing psychiatrists. In these meetings, Wagner falsely claimed that adolescent patients who received Paxil in GSK’s study “showed significantly greater improvement.”
She was also persuasive: according to internal memos, to psychiatrists attending the meetings who reported feeling more comfortable prescribing Paxil to young patients. Paxil revenues went up at least $900,000 from these doctors in 2000 alone. [GSK Complaint, para. 72-76]
Wagner has also been named in a complaint against Forest Labs. In a nutshell the complaint alleges that Forest promoted its antidepressants for pediatric use without FDA approval, and paid kickbacks to doctors to encourage prescriptions. The complaint also alleges that Forest Labs arranged for Karen Wagner to give promotional presentations on the pediatric use of Celexa and to serve as the chair of a seven-city Continuing Medical Education ("CME") program on treating pediatric depression.
Are we expected to believe that Wagner received no payment for this and she just attended the promotional presentations out of the goodness of her heart?
As, I said earlier, the content of Sullivan's article in the Clinical Psychiatry News is irrelevant. It should, however, be scrutinised given what we know about Wagner's links to the Pharmafia dollar. If the author of the article cannot even get one simple fact correct, a very important fact, then the content, in my opinion, is highly questionable.
I'll leave it to Michele Sullivan to rectify.
Forest Pharmaceuticals and Forest Labs are on the verge of getting a severe spanking after a lawsuit filed by two mothers from Missouri has alleged that Forest Pharmaceuticals and Forest Labs “misrepresented and concealed” information concerning the effectiveness of two company drugs for the treatment of depression in pediatric patients. It will be interesting to see if Wagner is brought to task over her dealings with Forest in this particular case. The suit was filed on behalf of the two Missouri mothers by Baum, Hedlund, Aristei & Goldman, PC and Pendley, Baudin & Coffin LLP.
Peter hits the nail on the head throughout this 15 minute interview.
He points out that drugs are the third leading cause of death in the world today, after heart disease and cancer. He also points out that the business model of the drug industry is organised crime and that they steal far more money and kill more people than the mob.
I'm thinking the word Pharmafia should now be used by as many patient safety advocates and groups as possible.
#Pharmafia
Gøtzsche is Co-Founder of The Cochrane Collaboration, and Director of the Nordic Cochrane Center in Copenhagen, Denmark.
Not quite chains but one could argue that Christina Schumacher, (Pictured) was held under duress for five weeks at the secure psych ward at Fletcher Allen Health Care in Burlington, VT.
So, is this just another case of a person who has found daily living unbearable, so unbearable that, overnight, they have developed a chemical imbalance in their brain thus rendering them mentally ill?
Well, if mourning the loss of a child is a mental illness then Schumacher deserved to be held. The thing is, and this is the crux of the argument, mourning is not a mental illness.
What this particular story shows us is how very easy it is to make money from the dead.
Schumacher's son, Gunnar, 14, was strangled by his father, Ludwig "Sonny" Schumacher Jr., 49, who later took his own life by hanging. Christina had separated from "Sonny" in July last year.
One day after learning her son was killed by her ex, Christina is admitted to a psychiatric unit because because mental health workers believed she posed a danger to herself and others.
It's called grief.
Schumacher has now been billed for her stay at the Fletcher Allen Health Care Centre.
So, let's just get this straight.
Your son is murdered.
You learn it was an ex-spouse who murdered him.
You then learn your ex-spouse killed themselves.
Ah, yes...most obvious reaction to this would be to become dangerous to yourself and/or others.
I'm not disputing that Schumacher felt suicidal, who wouldn't after hearing such devastating news? But who in their right minds would incarcerate a woman [because that's what it is] hours after she had learned her child had been murdered?
Mental Health Services had a couple of options here.
1. They could have, quite easily, "monitored" the situation.
As patients we are constantly told by antidepressant manufacturers that we may feel suicidal during the first few weeks of taking medication. We are told...or rather our doctor's are told, that the patient should be 'monitored' during this period. Why was Schumacher singled out for a 5 week stay at the 'Nutjob Hilton' then?
2. They could have listened to Schumacher and her friends who, according to reports, "disputed her need to be confined."
Her friends didn't have white coats and stethoscopes around their necks though...they did not have the skill to see Schumacher's chemical imbalance.
If indeed Christina Schumacher did pose a threat to herself and others then what changed over the five weeks she was held against her will? Did medication help her, is there some miracle pill that can, after five weeks, cure suicidal and homicidal thoughts?
I'm thinking there's money to be made here... I'm a bit late to jump on this particular bandwagon though as pharmaceutical companies and mental health services have been doing it for years.
I could, however, get some sort of loan and open up a motel or guest house. I'd pay the unemployed to scour the streets for anyone who looked remotely sad [Are you listening Cameron?].
My 'spotter' could then text me, "Woman, mid-fifties, looks sad, just saw her purchase a condolence card...obviously a danger to herself and others. I've attached a photo."
Great! A quick phone call to Mick "The Bruiser" Jones. "Hey Bruiser, get yourself down to the card shop on the High Street, attached is photo"
Mick "The Brusier" could then wait outside and nab the woman as she came out of the card shop.
I could then hold her for five weeks, bill her, and claim I was only acting in her best interests.
Isn't this, in essence, what Fletcher Allen Health Care have done with Schumacher?
Welcome to the world of mental health folks. A world where the actions of crazy people are actually committed by those employed in the system and not those dragged into it against their will.
A post appeared on the WZZM 13 website a few days ago that caught my attention and caused yet another deep sigh.
78 year-old Bob Farthing [Pictured] was found dead in the back of his car on Friday 17th January. Farthing was reported missing by his family on Wednesday, Jan. 15.
Details are emerging that show Farthing was having difficulty withdrawing from the antidepressant Seroxat, better known in the US by the brand name Paxil.
Farthing's daughter, Denise Shaheen, said there is only one explanation for the disappearance. "He is struggling with the withdrawal from the drug Paxil."
After using the antidepressant for 15 years, his family says doctors were weaning Farthing off of the powerful drug and putting him on other medicine. But it was a difficult process.
"He would have a couple good days, he would have a couple bad days. His bad days were very bad days," said Shaheen. "He became very depressed, very confused."
A video report of Farthing's disappearence and death is below.
Having experienced severe Seroxat withdrawal myself I really feel for this guy.
Of course, those who defend Seroxat, namely GSK and their attorneys, will argue that Farthing had been taking Seroxat for 15 years and the withdrawal he was going through was possibly his original depression returning.
Witnesses told police Farthing appeared confused when he was spotted later Wednesday afternoon at Blodgett Hospital. He had asked for help with directions.
Farthing was also reportedly seen Thursday in East Grand Rapids' Gaslight Village, where he stopped in Edward Jones to ask for directions to Blodgett Hospital.
His daughter, Denise Shaheen, earlier said Farthing was recently taken off a medication and may have been confused or suffering from medical problems. He reported not feeling well on Wednesday, she said.
Cause of death is unknown and is currently under investigation.
The withdrawal issue surrounding Seroxat has been debated many times. There are a number of people who suffer mild or no withdrawal problems at all.
So, what is being done to help those at the other end of the scale, those who suffer severe Seroxat withdrawal?
In a word, nothing!
The British drug regulator, the MHRA, have played down the issue of withdrawal time and time again, not only with Seroxat but with other SSRis too.
In fact, I personally met with the Chief Executive of the MHRA, Kent Woods, back in 2008, some 6 years ago, to discuss the withdrawal issue regarding Seroxat and other SSRi's.
Here's a summary of the minutes from that meeting.
Guidance on the Management of Withdrawal from Seroxat (Paroxetine) and Other SSRIs
Notes of a meeting held at MHRA on 2 September 2008
Present:
Robert (Bob) Fiddaman (RF), Campaigner, Author of Seroxat Sufferers Blog
Prof. Kent Woods (KW), Chief Executive, MHRA
Sarah Morgan (SM), Head of Pharmacovigilance Risk Management, MHRA
John Watkins (JW), Communication Manager, MHRA, acting as secretary
1. RF said he would like to discuss problems of withdrawing from Seroxat. He said that though his concerns centred around Seroxat, he recognised that other SSRIs posed similar problems which ought also to be addressed.
2. He produced copies of the Patient Information Leaflet (PIL) for Seroxat in which he had highlighted the 32 places where patients were told to talk with their doctor about various issues. He felt that too much of an onus was put on doctors, many of whom did not know enough about withdrawal problems and their management.
3. In answer to a question from KW, RF agreed that the focus of the meeting should be on the information going to doctors and perhaps also on their training.
4.KW noted that doctors do not generally refer to the PILs, nor indeed to the similar but more technical Summaries of Product Characteristics (SPCs). Instead, they use the British National Formulary (BNF), revised twice each year, and guidance produced by NICE. The NICE guidance on the management of depression was currently being revised; a draft is due to go out for public consultation in December 2008 with a view to publication in June 2009.
5. He emphasised that MHRA controls neither the BNF nor NICE in any of the matters they cover, but the Agency can and does make suggestions to both organisations about the information they provide.
6. RF illustrated the practical problems encountered by patients in withdrawing. He offered each of the others a jelly baby and asked them to bite off one-third. No problem. He then produced some Tic-Tacs (mints). It was immediately acknowledged that biting off a third was very difficult. Likewise with a Seroxat tablet, said RF. The liquid preparation was much better suited to dose tapering but doctors seemed largely unaware of it. He outlined his own experience of withdrawing over a period of 21 months. The liquid, administered through a syringe, helped that process, though – for him – not even tapering took him beyond the point where he felt he had to “go cold turkey”. He did that because he did not want the drug to continue to have a hold over him.
7. During withdrawal he experienced severe “zaps” in his brain. He described his dependence on the drug as an addiction, and exemplified that by relating his feelings of wanting to “rip the shop apart” if it turned out that they were out of stock.
8. KW noted that the term “addiction” ought to be reserved for circumstances which typically entailed cravings leading to increase in dosage, but suggested it was less important to argue about terminology than to acknowledge, as he did, that there are significant problems associated with withdrawal; the issue was how best to manage withdrawal. He noted that, as with benzodiazepines, those SSRIs which both act and disappear more quickly are more likely to pose problems with withdrawal. He did not know whether a switch to slower acting SSRIs had been researched as a potential solution, as it had proved to be for benzodiazepines.
9. KW said he was aware that RF had had some very good support from his doctor and wondered how widespread such support would be. RF believed that many doctors would not be able to provide that level of help, due to not knowing how to manage withdrawal. RF had sent the Agency a very large number of personal testimonies about difficulties that others had experienced during withdrawal.
10. RF pointed to guidance on withdrawal produced by Dr David Healy; KW said he had seen it but his concern about any guidance would be whether “one size fits all”, given the range and diversity of withdrawal experiences. That should not however prevent the development of authoritative guidance.
11. RF asked what authority MHRA had to issue warnings. Could it for example require warnings to be put on packaging like those on packets of cigarettes?
12. KW replied that the place for warnings to patients is within the PIL. If they were very prominent on the packaging then that might well deter patients who really needed the medicine from taking it. The Agency has control over PILs. KW outlined the improvements to PILs in recent years, largely due to testing them with users; a programme which will end very soon has been reviewing and revising the PILs for all medicines. RF acknowledged that there had been significant recent improvements in the Seroxat PIL. KW noted that there is still room for improvement in PILs but the Agency is now starting to explore other initiatives relating to PILs. It might for example become feasible to ensure that PILs are available to patients beforehand rather than at the time they start to take their medicines.
13. RF wondered whether MHRA had thought of including Yellow Cards with or in the PILs. SM replied that we had considered asking pharmacists to include them in the bag holding the package. KW noted that every edition of the BNF had a Yellow Card at the back but there was no obvious place for making it available to patients other than placing them in pharmacies and GP surgeries. Reports from patients were still relatively new. So far only about 10% of all reports come from them, but the quality of the information they contain is every bit as good as that from healthcare professionals.
14. KW asked RF what he thought of the Seroxat PIL’s Section 5, “Stopping Seroxat”. Early in the section it says “When stopping Seroxat your doctor will help you to reduce the does slowly …”. RF felt that this was over-optimistic. He also felt that the advice about dosage reductions of 10mg a week (which SM noted was based on clinical trials) was too large an increment in view of his own experience – he needed to reduce by 1mg a week, only practicable with the liquid – and the experiences of others. And he felt that the signposting to the liquid form, “It may be easier for you to take Seroxat liquid during the time that you are coming off the medicine” was inadequate. SM agreed that steering patients towards the liquid could be made more obvious; and it could be helpful if such a steer was also given to doctors, in some document such as the NICE guidance.
15. Referring again to the management of withdrawal in relation to benzodiazepines, KW read out the advice on management of withdrawal for that class of drugs that is in the current edition of the BNF. RF said he would have found it very helpful if that kind of advice, but about Seroxat / SSRIs had been available to him at the time he started to withdraw. He wondered how many doctors used the BNF. KW reckoned that almost every doctor will use it, with many of them referring to it frequently. When he was a clinician, he always carried around a copy of the BNF in his coat pocket.
16. KW thought that the inclusion of similar advice in relation to SSRIs could be suggested to the BNF. It might also be suggested to NICE for their guidance. And a potentially useful way of drawing prescribers attention to any new advice that emerged would be MHRA’s monthly Drug Safety Update. KW again stressed that though we might make suggestions about this to the BNF and to NICE, it would be for them to decide. While MHRA’s primary role is to regulate industry – with no jurisdiction over doctors, it is within the remit of both the BNF and NICE to inform and indeed to influence doctors.
17. RF asked whether MHRA would talk with David Healy. KW said he would be happy to have that happen. But it would be useful if others with experience of managing withdrawal were also consulted. Those present at the meeting could not immediately identify anybody else in the UK but MHRA would try to do that, perhaps with the help of one of its Board members.
18. RF asked whether the management of withdrawal could be covered in the training of doctors. KW explained the difficulty any organisation would have in influencing medical schools when each school determines its own curriculum.
19. RF enquired how the Agency kept up to date on research and indeed legal issues surrounding Seroxat. Had the Agency for example been aware of the “Glenmullen report” before he drew attention to it at a time when the Agency was still investigating GSK? KW could not recall at exactly what stage he personally became aware of the document but assured RF that the Agency kept track of developments generally, not just in the context of a particular investigation. SM described how her group undertake a weekly review of the literature in respect of all drugs, covering all the major journals. And pharmacovigilance also takes account of clinical trials and trends in Yellow Card reports.
20. The meeting concluded by recognising that though the focus had been on Seroxat, there were other SSRIs that posed similar problems, and that changes in prescribing practices, such as a reduction in prescriptions for Seroxat in recent years and increases for other drugs, for example Venflaxine, mean that some of the issues deserve to be dealt with in terms of the class of drugs rather than in relation to individual members of that class.
Almost a year later the MHRA did meet with David Healy. Here's the notes from that meeting:
Meeting to discuss awareness and management of withdrawal reactions with SSRIs and related antidepressants 26 June 2009
1. Introductions and background
MHRA explained that the background to this meeting was a meeting held with Mr Fiddaman in September 2008. Mr Fiddaman had raised concerns about a lack of awareness on the part of health professionals of withdrawal reactions with SSRIs and related antidepressants. Prof Healy explained that he had had a long term involvement with the safety of SSRIs and that he received a large number of e-mails directly from people withdrawing from SSRIs asking for advice on management of withdrawal symptoms. Before the meeting Prof Healy had provided documents that he had produced relating to the management of withdrawal from SSRIs.
2. Existing advice on management of withdrawal reactions with SSRIs/SNRIs
All agreed that most health professionals get their information from guidelines issued by the National Institute for Health and Clinical Excellence (NICE) and the British National Formulary (BNF) rather than directly from the Summaries of Product Characteristics (SPC), although it was noted that the SPC was very important as it dictated the information that would be available to the patient through the Patient Information Leaflet. MHRA informed Prof Healy that they had provided input to the recent consultation for revision of the NICE depression guideline and that the revised guideline would be available towards the end of the year. MHRA had also informed the BNF that they were looking at the area of withdrawal reactions and would contact them in the future regarding proposals for updates to the relevant sections of the BNF. MHRA also raised the important role played by Prescribing Advisors in the Primary Care Trusts in influencing prescribing practice. Prof Healy said that a key point not included in the guidance currently available was the existence of liquid formulations of SSRIs which could be useful in the management of withdrawal to allow slow tapering. Prof Healy also stated that before treatment started there should be a discussion between the prescriber and the patient about the possibility of withdrawal reactions.
3. Awareness of withdrawal reactions in clinical community
Prof Healy expressed the view that general practitioners (GPs) were not aware that withdrawal reactions on stopping SSRIs could be prolonged in some patients and were not aware of how to manage withdrawal reactions in these patients. Prof Healy was concerned that GPs may instinctively advise patients to withdraw by taking tablets on alternate days and this was not an appropriate approach.
4. New evidence relevant to management of withdrawal reactions
Prof Healy was not aware of any new evidence relevant to the management of withdrawal reactions. When asked if he had a view on the size of the problem of serious and prolonged withdrawal reactions with SSRIs, Prof Healy said that this was not possible to measure. Prof Healy said that while the propensity of an SSRI to cause withdrawal reactions was often thought to be only related to the half-life of the drug, this seemed unlikely to be the case – it could also be related to the potency of the different drugs at the serotonin reuptake site. The lack of understanding of the problem contributes to a lack of effective solutions.
MHRA asked whether in his view there was any way that patients who were more at risk of prolonged withdrawal reactions could be identified. Prof Healy said that he felt that from his experience women seemed to be more at risk than men but it was unknown whether this was because more women than men were treated with SSRIs. MHRA said that their review of the issue had not identified any link between the risk of withdrawal reactions and the gender of the patient. Prof Healy considered that there was little evidence available on how to manage patients who had difficulty withdrawing from SSRIs. All agreed that this was a very difficult area to study as the management of the patient would differ depending on the patient.
5. Dependence/withdrawal for women of child-bearing years
Prof Healy had asked for the issue of use of SSRIs in pregnancy to be included in the agenda. He said that it was an important issue and the subject of upcoming court cases in the USA. Prof Healy said that it was important that women of childbearing years were appropriately informed of the risk of withdrawal reactions with SSRIs before beginning treatment and stated that in his view doctors may be liable under the Congenital Disabilities Act 1976 if they did not adequately inform patients of the risks of treatment during pregnancy.
MHRA said there had been communications about a small risk of congenital malformations associated with paroxetine and this issue was under further discussion at EU level. Prof Healy highlighted a recent publication describing an animal study looking at reproductive toxicity of a variety of SSRIs. MHRA asked for the reference and to be kept informed of any further new evidence of relevance to this issue.
MHRA noted that NICE had published its antenatal and postnatal mental health: clinical management and service guidance and that it was important that NICE was kept informed of any new evidence or advice in this area. MHRA agreed to find out whether review of the guideline was planned and to let Prof Healy know the best contact point for communication on this issue. Post meeting note: Prof Healy confirmed post-meeting that he had contacted NICE on this issue.
6. Opportunities for better communication with health professionals
Prof Healy said that the focus should be on highlighting to GPs that withdrawal reactions could be serious and prolonged in some patients and agreed that NICE and the BNF would be reasonable routes.
MHRA thanked Prof Healy for attending the meeting and agreed that it would be important to keep in contact on important new evidence in this area.
So, two meetings in the space of approx 12 months.
To my knowledge the MHRA have not kept in contact with David Healy.
I severed ties with my communications with them in 2009. I had brought the Lyam Kilker trial to their attention. Lyam was born with heart defects. His mother had taken Seroxat during her pregnancy. A jury found Seroxat to be the cause of his heart defects.
After many emails back and forth to the MHRA I decided that I was flogging a dead horse. The MHRA were just never going to acknowledge that Seroxat was a teratogen.
Here's the email I sent them.
Simon was, at the time, Director of Communications at the MHRA.
----- Original Message -----
From: fiddaman
To: Gregor, Simon
Cc: REDACTED
Sent: Sunday, November 22, 2009 8:11 PM
Subject: MHRA - I am done!
Dear Simon Gregor, and other MHRA staff included in on this email; namely Kent Woods, Alasdair Breckenridge and Sarah Morgan.
You will note from the Cc list I have included some familiar faces, I think all but one of them will be familiar to you.
The 'give2manie' email address is an email that you have probably not come across before. It is the email address of Julie Edgington, an American. Her child, Manie, was born with transposition of the great arteries [TGA].
GA means the aorta and pulmonary arteries in the heart are switched. When a child is born with TGA there is very little oxygen in the blood. The aorta receives the oxygen-poor blood from the right ventricle, but it's carried back to the body without receiving more oxygen. The pulmonary artery receives the oxygen-rich blood from the left ventricle but carries it back to the lungs.
Manie's mother, Julie, took paroxetine whilst she was pregnant.
The reason behind this email and the reason I have included the familiar faces is because I want them all to know where I currently stand with the MHRA.
Your limp-wristed response to my question, Is Seroxat a teratogen, was really the straw that broke the camel's back. You have gone back to your old ways of fence sitting on life threatening issues.
Time and time again you are faced with evidence yet you refuse to acknowledge it. Seroxat IS a teratogen, you know it and so do I... and I imagine the others included on this email do too.
Over the past couple of years the MHRA have opened their doors to Seroxat campaigners, it was a nice gesture but I firmly believe it was merely a token one. Maybe you thought by opening your doors, the problem would simmer - Keep your friends close, and your enemies closer.
Simon, you have picked my brains over the past year or so with regard to your yellow card system, a system that is troubled, outdated and, dare I say it, about as useful as a chocolate teapot.
You are very good at what you do Simon, I bear you no malice.
Moving on to your CEO, Kent Woods. Charming man, well he was for the hour meeting I had with him. Since then he has failed to answer any of my emails. Whether he thinks I'm some ruffian from a council estate should not alter the fact that I have some serious complaints that need answering.
He has had plenty of opportunities to correspond with me but has chosen not to. The 'Kent gets hundreds of emails a day' excuse does not wash with me. Even if he did, does he ignore them all or does he just choose to answer the one's he thinks are important?
Alasdair Breckenridge is big enough to proclaim on national TV that there is nothing wrong with Seroxat, and so I gather at various dinner functions he has attended. Remind me of his role again at the MHRA?
Your recent response regarding the teratogen issue was expected. It was a classic cover your ass answer - in fact I shouldn't really use the word 'answer' as you never actually answered the question did you?
As you are well aware GlaxoSmithKline were just found guilty by a Jury in the United States. Paxil [Seroxat] was found to be the cause of the heart defects Lyam Kilker was born with. If a jury can find that Seroxat caused heart defects in a child then I have to ask myself why regulator's can't. Your Chairman being a former employee of GlaxoSmithKline does not really help matters nor does your Head of Licensing, Ian Hudson, another former employee of Glaxo.
You are not protecting the public with regard to Seroxat and other SSRi's. Your stubborness is staggering. You choose to protect GlaxoSmithKline and anyone who sides with them, is, in my opinion woefully misguided and/or corrupt.
Seroxat IS a teratogen, I should not have to send you the evidence - you should already have it, you are a regulator after all.
I have decided to call it a day with the MHRA. There is no reason for me to correspond with you anymore. I cannot and will not have my name associated with cowards - because that's what you are. There is no direct accusation at individuals here - this is aimed at the MHRA as a whole.
You need to take a good look at yourselves and ask whether or not you are doing enough to protect the public, in particular children. Personally, I don't think you are.
For the other patient/advocates involved with the MHRA on the patient and public engagement (PPE) it is entirely up to you if you wish to continue engaging in talks with the MHRA. My decision is based on my own belief that the MHRA are simply not protecting the public and no matter how many doors they open to patients will not matter a jot because they will never take the side of the likes of myself or young Manie Edgington.
There are a further 630 cases to be heard in the USA regarding children being born with heart defects. The Kilker trial was a landmark case and has set a precedent, the others, I assume, will be settled out of court. No liability. No public record that Seroxat is a teratogen.
Which, will suit the regulators just fine.
I do not want a detailed explanation of the reasons why you could not answer a simple question. My main concern is doctor's in the UK are still prescribing a teratogen - because the MHRA are too limp-wristed to condemn it.
Approx two years later the MHRA announced that they were rolling out an SSRI Learning Module for healthcare professionals. It would be nice to think that the meetings with myself and David Healy had some influence on this project but the more I looked into it, the more dumbfounded I became.
On the subject of severe SSRi withdrawal the MHRA were telling healthcare practitioners to recommend "specialists" to patients.
With this in mind I sent the following to the MHRA:
Can the MHRA provide me with a list of specialists experienced in SSRi withdrawal that are a; in the UK and b; available on the NHS.?
They couldn't provide me with any such list of 'specialists.
I wrote a series of articles on the SSRi Learning Module, all of which can be found at the foot of this post.
It's not just the MHRA that should come under fire.
On May 6, 2007, Neil Carlin found his 18-year-old daughter, Sara, hanging from an electrical cord in the basement of the family’s Oakville, Ontario. A bottle of Seroxat, which her family doctor had prescribed to her 14 months earlier, was found at the scene.
The inquest into Sara's death was high profile and was covered extensively by the Canadian media. I covered the inquest myself, reporting what the media failed to report through fear of lawsuits from GlaxoSmithKline.
After a gruelling 10 day inquest a jury issued 16 recommendations on June 28, 2010.
It fell short of blaming Seroxat on Sara's death.
To date not one of the 16 recommendations have been implemented.
“We realized it’s a bullsh–t process,” Neil Carlin said. “They go through the motions to give the public a sense of confidence they’re on top of it. Nobody really cares or follows up.”
The inquest that the Carlins had pushed for became, in their eyes, nothing more than “window-dressing.”
“It’s sort of a hollow victory,” Carlin said. [1]
I've met Sara's parents. Spent some time with them in Canada. They remain firm friends.
So, with all of the above, exactly what is it we have learned? well, as consumers we pretty much know how dangerous Seroxat is. Those that regulate drugs like Seroxat have failed and continue to fail. Coroner's who carry out inquests into suicide, in the main, fail to make any connection between suicides and SSRi's. If they opened their eyes they could be doing the public a great service. Alas, they are blinkered and convinced that drugs do not cause a person to kill themselves...it's the illness.
Chief Executive of the MHRA, Kent Woods, retired last year. His position was filled by Ian Hudson.
I'll leave you with an email I sent to Hudson on Nov 8 2013. He never replied.
Dear Mr Hudson,
As I understand you are now Chief Executive of the MHRA. I'd congratulate you but we both know that I'd be lying with those congratulations given your past links to GlaxoSmithKline and Seroxat.
That aside, I have to remain professional.
My question to you is one of great concern and one that I shall be making public on my blog http://fiddaman.blogspot.com
Are you, or do the MHRA plan to reevaluate the current recommendations that pediatrics should not be prescribed SSRi's?
I ask as it has come to light that MHRA consultant, Stephen J W Evans, has recently co-authored a study where he and the other authors call for a re-evaluation of the current prescription of SSRIs in young people - Back story here.
This email, along with your answer, if you are brave enough to answer that is, will be published on my blog.
Forest Pharmaceuticals, Inc. and Forest Laboratories, Inc. have been up to no good. Yet another pharmaceutical company who have, according to a new lawsuit, been holding back information concerning the effectiveness of two company drugs for the treatment of depression in pediatric patients. Those two drugs being the antidepressants Celexa and Lexapro.
Naughty, naughty.
The lawsuit, filed by two mothers from Missouri who are being represented by Baum, Hedlund, Aristei & Goldman, PC and Pendley, Baudin & Coffin LLP, claims that "Forest marketed antidepressants Celexa (citalopram) and Lexapro (escitalopram) as effective for use in pediatric patients, even though studies showed evidence to the contrary".
The plaintiffs, Ruth Dunham and Tanya Shippy, allege "Forest deprived consumers of the ability to make an informed decision about whether to purchase or prescribe Celexa or Lexapro for their children by withholding information about the negative efficacy studies and engaging in an aggressive marketing campaign designed to mislead consumers and physicians".
A pharmaceutical company aggressively marketing drugs for kids when they knew the drugs weren't effective in kids?
Surely not, I mean stuff like this just doesn't happen, right?
U.S. District Judge Nathaniel M. Gorton of Massachusetts stated in his ruling that the allegations are viable under the Missouri Merchandising Practices Act (MMPA). The MMPA prohibits “deception, fraud, false pretense, false promise, misrepresentation, unfair practice or the concealment, suppression, or omission of any material fact in connection with the sale or advertisement of any merchandise in trade or commerce.”
Be interesting to see how this one goes. Forest will be up against it.
Baum Hedlund have represented more than 4,000 individuals across the US in personal injury and wrongful death cases involving harmful medications. They spanked those other pediatric suppressors, GlaxoSmithKline, on more than one occasion.
Celexa and Lexapro are antidepressants in the SSRi class, they work pretty much in the same way. Some believe [myself included] that Lexapro only ever came about because the patent for Celexa was running out. Change a molecule here and there, change the name, submit to the FDA and...VOILA...a new drug hits the market that does exactly the same as the older drug... in this instance does nothing, apart from causing suicidal ideation and self harm for pediatrics who take it!
Why promote anything that doesn't work? Moreover, why promote something that is dangerous for pediatrics?
Forest have, it appears, taken a leaf out of GSK's book here. Who can forget the Paxil 329 debacle?
Be interesting to see if any evidence comes out of this trial that shows yet more ghostwriting shenanigans or if Forest's reps were just as adamant as Glaxo reps to "get the sale" at whatever cost.
Grown men and women playing with children's lives. Don't you just love the pharmaceutical industry!
The full press release can be read on the Baum Hedlund website HERE.
My hits went over the one million mark a short while ago. My original Blogger counter went from 999,999 to 100,000 at around 11.30am UK time. I think Blogger counters only have 6 digits so I've just installed a new counter.
A few thanks must go out to the following...
Dad - His sense of pride in me has kept my feet firmly on the ground. - I salute you
Mom - You passed on that old Irish stubbornness, I hope you are still throwing those bricks. - I salute you
My sisters, Deb and Jan. There may have been times when I've appeared frustrated and distant. Thanks for standing by me and showing your support.
My boys - Danny, Marc and Gary - Collectively you are alive in me. Part of you all has become the writer.
Benn - My four-legged friend, thank you for the walks and the company when I was mulling things over. - I salute you
CCHR International, UK, and Canada - These guys rock and they honoured me a few years back with a couple of awards. I met people because of them. I travelled because of them. I learned that this wasn't just about Seroxat and withdrawal. It was about many other antidepressant type medications. Marla, Jan, Lori, Margaret, Sue & Brian, for showing me how to flourish as a writer, as a human. CCHR still rock, they still honour the men and women on the street, normal people, like you and me. - I salute you
Rob Robinson - The Godfather of Paxil activists. You kicked some serious ass my friend. Thank you. - I salute you David Healy - An inspiration and not a maverick. - I salute you
Shelley Jofre - The BBC's own ankle-biter who has investigated GSK, the MHRA and Seroxat on four separate occasions. She kept the fire going in my belly. - I salute you
Neil and Rhonda Carlin - Parents of Sara, who tragically killed herself whilst on Paxil. Your friendship has kept me going, your belief in me has kept me strong. - I salute you
Baum, Hedlund, Aristei & Goldman - Top US Attorneys with a great track record against GlaxoSmithKline. I will live forever in your debt. Gary, Rob, Ash, Foz, Mo, Peggy, Liz, Twyla, Michael, Leemon, Cindy - I salute you
The Dixie Chicks, without whom I wouldn't be here. They, unknowingly, helped me through severe Seroxat withdrawal. - I salute you
Sarah-Jane Richards - For the many chats over the phone, for giving me hope, for showing me what tenacity and doggedness are all about. - I salute you
Evelyn Pringle - Investigative journalist who had a real influence on me with her work on the early Paxil cases. - I salute you
Stuart and the late Claudette Jones - A Christmas present every year, you never forgot. Much love to you both. - I salute you
Chipmunka Publishing - For having the balls to publish my book. - I salute you
To all bloggers past and present - you have all been part of my journey. - I salute you
GlaxoSmithKline and their Attorneys - For spectacularly giving me stories to write. As long as you keep messing up, I'll keep writing. - Middle finger salute to you
There are many, many more people I'd like to thank, the list is endless, you all know who you are. - I salute you
A huge thank you to you, the readers. Thank you for your support over the past 8 years. Thank you for coming back time and time again. - I salute you
This post is dedicated to every single man, woman and child [including fetuses] who have lost their lives because of the side effects of SSRi medication. - I salute you.
I salute you all.
The year ahead is looking pretty damn good. Time to stretch those legs.
Bob Fiddaman
Coming soon - A 17 page blog post - Ryan, Glaxo's "Non-Viable" Fetus
Although the person in the article lists a number of visual symptoms, it is worth noting that their main problem is blurred vision and poor night-vision.
If you experience these problems, please get in touch.
We're very keen to hear from SSRI users, but we would also be happy to hear from other anti-depressant users. You don't have to be based in the UK, providing you can arrange the same testing.
We need to get this message out to as many anti-depressant users as possible. Please help us to spread the word.
Everyone and anyone that knows me will tell you that I am an AC/DC nut. They'd be right.
I first heard them in 1978. I was at the local youth club disco and listening to the usual disco stuff, some Mud, Slade and Sweet being thrown in for the glam rock fans. Then, BAM! I heard them. Little did I know that they would have such a profound effect on me, one that I still carry today, some 36 years later.
Whole Lotta Rosie [1] from the Let There Be Rock album was the first song I heard. My leg just started moving along to the rhythm, worse case of restless leg syndrome anyone would ever likely encounter.
[1] Whole Lotta Rosie
From that point I was hooked. I saved and purchased my first AC/DC album, Powerage. It was played to death, quite literally as I had to go out and purchase another copy some years later.
Powerage, for me, and many other hardcore AC/DC fans, stands out there as one of the finest rock n' roll albums ever recorded. It still stands up today. For me, Gone Shootin' [2] pretty much defines what AC/DC are all about - the groove.
[2] Gone Shootin'
The back catalogue was purchased and a year later I was rushing to HMV for their new release, Highway To Hell. They didn't disappoint. It's a work of art that sees the then vocalist, Bon Scott, belt out songs that would later become classics, still being used on AC/DC's set list today. For me, Night Prowler [3] is one of the most underrated songs on the album, to my knowledge AC/DC have never performed this live. Night Prowler has quite a history, Google "Richard Ramirez + AC/DC" to get the back story. Night Prowler is dark, it's bluesy, it's pure genius.
[3] Night Prowler
So, why am I writing about AC/DC on a blog that essentially takes a critical look at the pharmaceutical industry and medicine regulators?
Well, because I want to is the simple answer.
AC/DC have been, and still are, a huge part of my life, they are my natural antidepressant, better still, one doesn't endure side effects when listening to AC/DC.
Bon Scott [AC/DC vocalist 1975 - 1979] tragically died in 1980. I've been lucky enough to visit his birth place, Kirriemuir, Scotland, and his place of rest, Freemantle, Perth W. Austraila.
AC/DC, thankfully, continued and soon found a replacement vocalist in Brian Johnson.
Johnson had had previous chart topping success in the UK with Geordie, their most successful single release being All Because Of You which entered the top 10 in the UK charts.
Being an AC/DC fan has its downside. The years between studio albums can be tedious. They keep themselves to themselves and rarely do interviews [unless they are promoting a tour or album].
They've kept my interest going for 36 years, they are, without doubt, the finest rock n' roll band of all time.
They have given millions of people pleasure over those 36 years, one only has to look at the joy on the faces of the Argentinian fans in the video below [4]
I thought I'd just mention them before my blog hits one million views. They helped shape me into the person I am today.
I salute them.
[4] You Shook Me All Night Long
Who needs medicating when you have five guys who can rock like these guys?
Watching AC/DC perform live isn't just about witnessing the best rock n' roll band on the planet, it's a spiritual experience.
I decided to look into the law/rules of disclosure of documents and found it fascinating. Law fascinates me, it also makes me laugh, at times, because it can be so perverse.
Anyway...
Disclosure Of Documents
If you are a party to a litigation you are required to share information with your opponent. This includes documentation that supports your case and documentation that can potentially be detrimental to your case.
This process, known as disclosure, requires parties to make all documentation relevant to the matter in dispute available. The objective aim being to enable the Court to ensure that justice is done.
Pre-action disclosure
Before commencing proceedings parties are required by the pre-action protocols to share information.
Standard disclosure
Standard disclosure requires the parties to carry out a reasonable search for documents which record information that they intend to rely on, or which adversely affect or support another party’s position.
The parties are required to search for all documents that relate to the issues in dispute.
"Parties should remember that the disclosure obligation continues until the proceedings are concluded. The duty does not simply come to an end once the initial disclosure process has been complied with. If a relevant document comes to light after initial disclosure, or even if it is created after initial disclosure, it must be disclosed." - David Rosen, Head of Litigation, Darlingtons Solicitors LLP
I'm unsure what would happen if a party was found to have not adhered to the above. Is it a criminal offence? Could a Judge call for a mistrial if he/she were to find out that one of the parties [let's say defence] had withheld information on purpose because it was of benefit to the prosecution and detrimental to the defence?
Fascinating stuff. It doesn't go on today though... or does it?
It would make quite a story if it did, don't you think?
Fraudulent concealment (1) , I'm sure, would be frowned upon by many Judges, particularly those in the Supreme Courts.
Bob Fiddaman
(1) Fraudulent concealment - Deliberate hiding, non-disclosure, or suppression of a material fact or circumstance (which one is legally or morally bound to reveal) with intent to deceive or defraud in a contractual arrangement.
I started writing this blog back in 2006. I was peeved at the way the MHRA [UK Medicine (ahem) Regulators] were handling a series of emails I had sent to them about the antidepressant Seroxat [known as Paxil in the US]
I'm not going to go into detail of why I pursued and dug deeper, I've already done that in my book.
Well, one look at my blog counter and you will note that I'm just over 5,000 clicks off a million hits.
With that in mind I wish to share with you all an open letter to Glaxo CEO, Andrew Witty - that's Sir Andrew if you believe all the hype behind that regal pomp.
Dear Mr Witty,
Seeing as your American lawyers King & Spalding have been keeping tabs on me over the past few weeks I feel it's a great opportunity to ask you if you would like to donate a couple of bottles of the finest champagne to a worthy cause?
As you are probably aware my blog has been running for some considerable time now and I am fast approaching 1 million views. I'd love to celebrate that millionth hit with a couple of bottles of champagne. I'll toast your [ahem] good name and those of past employees of Glaxo.
You may think I'm being greedy asking for two bottles but there's a reason I am requesting a set. You see, one is for me and me alone. I think I deserve it after highlighting stories of GSK, stories that the mainstream have avoided like the plague. You should be thanking me for bringing these stories to your attention Andy baby.
The other bottle will be for more sombre purposes. I wish to toast the dead kids killed by Seroxat. I wish to toast the dead fetuses mothers were forced to abort because Seroxat caused severe birth defects. I wish to toast all those who suffered severe withdrawal at the hands of Seroxat. I also wish to toast those who are still hooked on Seroxat because they have become addicted to it.
Hmmm, I'm thinking two bottles won't even scratch the surface. Maybe a crate will suffice?
I'm not much of a connoisseur when it comes to champagne, I'm more of a beer person, but this is a special occasion, don't you think Andy?
One million hits, that's one million people who have read the work of a nobody. The guy who was wasting his time because GSK will just ignore him and he will, like so many others, just disappear.
I'm still here Andy.
I may just be a flea on a giant sewer rat but I'm betting that I have become annoying hey? How's that itch on the rat, has it spread to a rash yet?
Your American attorneys will no doubt tell you that I'm sitting on something pretty powerful, something that will question your recent comments regarding Glaxo's past behaviour. "All part of an era", I think you were quoted as saying?
Well, sadly, it's not all part of an era. The concealment is very much alive today, just ask King & Spalding.
Hey, you ever thought about meeting with Seroxat victims, you know, the parents who lost their kids because they killed themselves whilst on your drug. How about the mother's who gave birth to babies who had birth defects or those who had to abort because the Seroxat had caused so much damage that the chances of survival for the children they were carrying were slim to zero.
So, just a simple request. A crate of your finest.
Oh, don't get popping those corks and replacing them either.
Bizarre behaviour coming from King & Spalding, GSK's highly paid defence lawyers.
No sooner was the year over when they were checking me out to see if I had wrote anything on a particular Paxil birth defect case that they successfully argued. [Fig 1]
Fig 1
What's up K&S, is something niggling at you?
What possible information do you think I have that you don't have?
Great question huh? If you, as [ahem] respected attorneys had information detrimental to your defendant you'd still be obliged to hand it over, wouldn't you?
I'm left wondering who are the bad guys here, is it GSK or is it their attorneys King & Spalding?
That's a question I will ask soon.
I've wrote a 16 page blog post entitled, "Ryan, Glaxo's Non-Viable Fetus". I've been sitting on it for some time out of respect for the mother concerned.
You see I, just like King & Spalding, know how to play the game. I know the mechanics of the waiting game GSK and their lawyers play. I know that litigation isn't about justice, it's just about getting the best deal for all concerned. I know that neither GSK or King & Spalding want this particular case to go to trial again and I know they will use delay tactics to their advantage to grind the plaintiff down. I think this woman has been through quite enough but she remains strong.
As for the information I hold and how I obtained it... well, that's a story just waiting to be told.
I can wait.
Meantime, this is for King & Spalding. (Not so much of a mystery girl anymore, eh guys?)
