Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Friday, February 28, 2014

Marriott Hotels and the Case of Justina Pelletier

One way to give stubbornness a swift kick to the nether regions is to talk money... or lack of it.

Yesterday I Tweeted an article I wrote about Justina Pelletier to the Boston Children's Hospital's corporate sponsors. One of those sponsors, namely Marriott Hotels, replied. The reply [below] has since been circulated around social networks and Marriott are receiving much acclaim for their stance.

Here's the tweet...

The article I tweeted to Marriott and the Boston Children's Hospital five other corporate sponsors was critical of the treatment of Justina and can be read here.

The response from Marriott should raise the red flag for the 5 remaining corporate sponsors who have failed to speak out  regarding the treatment of 15 year-old Justina, namely; Aquafina, Roche Bros, TD Bank, Waste Management and Toyota.

Those that are up to speed on the whole Justina Pelletier case will know that there's debate between doctors about her diagnosis. On one hand we have a disease doctor at Tufts Medical Center who diagnosed Justina with mitochondrial disorder, a chronic, genetic disorder that occurs when the mitochondria of the cell fails to produce enough energy for cell or organ function. Then we have another opinion of another doctor/psychologist who claims Justina has somatoform disorder, an apparent mental disorder characterized by symptoms that suggest physical illness or injury.

Last year Stephen Marriott, whose father presided over the Marriott International business empire, died at age 54. The cause of death, according to his father, was complications from mitochondrial disease. The very same disease Justina Pelletier had been diagnosed with. The very same disease that those involved within the mental health system are claiming Justina does not have.

Stephen's father also added, that his son was "...properly diagnosed about 20 years ago and in recent years had taken an experimental drug that probably helped prolong his life."

There have been many media reports that have suggested that Justina's medication to treat her mitochondrial disease have been stopped.

One has to applaud Marriott Hotels for taking a stand here. Okay, they are only looking in to the issues surrounding the case but to publicly admit that they have notified the 'appropriate people within the organization' is a brave move and one that may just haunt the Boston Children's Hospital.

It will be very interesting to see how this one develops.

I will, of course, keep you posted.

Bob Fiddaman.

Back Stories:

Boston Children’s Hospital - A Prison For Children

Justina Pelletier: A Pawn in a Psychiatric Game of Chess

Thursday, February 27, 2014

Justina Pelletier: A Pawn in a Psychiatric Game of Chess

Earlier this week I wrote about 15-year-old Justina Pelletier, a young girl caught in the mental health system and the opinions of apparent professionals.

In brief, Justina was diagnosed with mitochondrial disorder, a chronic, genetic disorder that occurs when the mitochondria of the cell fails to produce enough energy for cell or organ function.

Her parents, Lou and Linda Pelletier, took her for a routine visit to a Connecticut Children's Hospital back in 2013. Justina had come down with the flu, which can affect mitochondrial disease sufferers in a more pronounced way than the average person.

Instead of being treated for her flu, Justina was referred to a psychologist who, after a brief conversation, diagnosed her with somatoform disorder, an apparent mental disorder characterized by symptoms that suggest physical illness or injury.

24 hours later Justina's parents were served a 51A, a report of alleged physical or emotional abuse. By treating their daughter with medication for her mitochondrial disorder they were deemed to be 'abusing' her by over-medicalizing her.

This was back in 2013.

A few days ago, her parents attended a hearing at a Boston courthouse opposing the wishes of the Department of Children and Families who wanted to place their teenage daughter in foster care on Boston’s North Shore.

Bizarrely, Juvenile Court Judge Joseph Johnston agreed with the Department of Children and Families.

A gag order has been in place since 2013 that prohibits Justina's parents from speaking to the press about their daughter's plight.

Yesterday, the Boston Globe, who have been covering this story for a while, reported that Justina "is likely to remain for now at a Framingham residential facility where she’s been for the past month and not move to a Merrimac foster care placement that was discussed in juvenile court Monday."

This from the Boston Globe:

At the closed-door hearing this week, Juvenile Court Judge Joseph Johnston spoke about a plan by the state Department of Children and Families to transfer 15-year-old Justina Pelletier to Shared Living Collaborative in Merrimac. But this facility has apparently backed away from the idea, largely because of the highly contentious nature of the case and the national media attention it has drawn, these sources said.
Meanwhile, one of the sources said the judge on Monday expressed openness to allowing Justina to return to her West Hartford, Conn., home to live with her parents, as long as certain oversight conditions were met.
Many social networks have been outraged by the treatment of Justina and various campaigns have been started, I myself suggested that Boston Children's Hospital's corporate sponsors be boycotted whilst others created Facebook pages and expressed their anger via Twitter.

It would appear that the "professional adults" just haven't got a clue what they are doing.

We have the medical opinion of a mitochondrial disease doctor at Tufts Medical Center who took into account all the evidence so diagnosed and prescribed drugs to treat Justina's mitochondrial disorder [part of his evidence was that Justina's sister also had the hereditary disorder].

Then we have the opinion of a psychologist who, after a brief conversation with Justina, decided she was 'faking it' - This opinion led to Justina being taken away from her parents and having her treatment for mitochondrial disorder stopped and being treated for an "illness" that she probably hasn't got.

After being passed around from pillar to post Justina still, after many months of uncertainty, still remains in limbo.

This is nothing more than Justina being used  as a pawn in a game of psychiatric chess, and not a very good one at that.

It's time for Justina to go back to where she belongs - to her family home - to her loving parents.

It's also time for the mental health services involved in the decision making of this poor girl to take a long, hard look at themselves.

Chess just isn't for them. One has to have a certain level of skill to play the game.

Bob Fiddaman

If you are going to Tweet this story, please use #FreeJustina as a hash-tag.

Wednesday, February 26, 2014

Will Cameron Call off the GSK Hounds?

The South China Morning Post is reporting that Britain's Serious Fraud Office plans to prosecute or fine GlaxoSmithKline for engaging in bribery in China.

For those that don't know, GlaxoSmithKline were implicated in a series of bribery allegations last year in China. The Chinese government accused British pharmaceutical giant, Glaxo of paying almost $500 million in bribes, mainly to doctors who prescribed its products.

The allegations have been played down by Glaxo chief, Andrew Witty, who last year claimed, that there are control mechanisms in place to prevent bribery and other forms of corruption, but that the methods these individuals used “would have been difficult to find using our controls.”

The allegations also claim that Glaxo reps were trained to offer sexual services to Dr's in an effort to get them to prescribe more drugs. China’s official news wire, Xinhua, last year quoted a 35-year-old female “medical representative” who reportedly worked for a GSK regional sales manager named only as Mr Li.

The woman, named as Ms Wang, said “some executives gave clear directives to the sales department to offer bribes to doctors with money or opportunities to attend academic conferences.”

Ms Wang said she would even go so far as fulfilling some doctors’ “sexual desires” in order to “meet their needs” and persuade them to prescribe more drugs.

Furthermore, it's been alleged that Glaxo reps organised all expenses paid trips for Chinese doctors to tour the scenic river town of Guilin, China's most picturesque region which has long been one of the world's most famous travel destinations.

It's also alleged that Chinese healthcare professionals were also sent to other exotic destinations such as Hungary and Greece in an effort to get them to prescribe Botox, best known for its ability to combat crow's feet and other facial wrinkles. Botox has another 26 treatable indications which include chronic migraines,  uncontrollable blinking and overactive bladders, ironically, losing control of your bladder is one of the side effects associated with Botox.

It will be interesting to see how this unfolds. Personally, I don't think the British government or fraud squad will intervene. Witty is a close friend of British PM, David Cameron and his leverage to pull GSK out of the UK should persuade Cameron to call off the hounds.

Bob Fiddaman

Monday, February 24, 2014

Boston Children’s Hospital - A Prison For Children

15-year-old Justina Pelletier was diagnosed with mitochondrial disorder, a chronic, genetic disorder that occurs when the mitochondria of the cell fails to produce enough energy for cell or organ function. From that point on she was being treated by physicians at Tufts Medical Center.

Her parents, Lou and Linda Pelletier, took her for a routine visit to a Connecticut Children's Hospital back in 2013. Justina had come down with the flu, which can affect mitochondrial disease sufferers in a more pronounced way than the average person.

Because of this, Justina was, on the 13th February 2013, transferred to the Boston Children’s Hospital.

Upon her arrival Justina, suffering from the flu and dealing with her mitochondrial disorder was sent to see a neurologist, who, Justina's father said, didn't look at her medical history or contact her other doctors. This neurologist, according to Justina’s father, said he thought the illness was all in Justina’s head — that it was somatoform disorder, a mental disorder characterized by symptoms that suggest physical illness or injury. In other words, Justina was faking it. Had this quack of a neurologist bothered to look at Justina's family history he would have learned that Justina's elder sister, Jessica [25], also has mitochondrial disorder. He would also have learned that mitochondrial disorder is hereditary. Justina was kept in hospital.

The following day, on the 14th of February, her parents went back to the Boston Children’s Hospital with a couple of advocates intending to have her discharged and returned to Tufts.

Too Late

By now, mental health services had dug in its heels and had decided that Justina could not be released. Her parents were faced with security guards and served a 51A, a report of alleged physical or emotional abuse.

To add insult to injury the Pelletiers were accused of over-medicalizing their daughter. Can anyone else see the irony in this?

Since when did mental health care about how many illnesses teenagers were diagnosed with or how many prescription drugs teenagers took? If anything, it's mental health services who dish out more harmful drugs to kids than your average drug pusher standing on a street corner, it's also mental health that label kids at the drop of a hat with fictitious mental disorders.

Justina was transferred to Boston Children’s Hospital’s Bader 5 psychiatric unit on April 9, 2013. There she was treated for somatoform disorder. According to a document from Boston Children’s given to the Pelletiers, Justina’s treatment included a “behavioral plan formulated with input from all relevant disciplines which will day schedule, feeding and functioning plans with a therapeutic approach.” Physical therapy was included as well.

Pretty safe to assume then that Justina would have been treated with some kind of "mental illness" drug. And these knuckleheads had the audacity to accuse Justina's parents of 'over-medicalizing'!

This is just utterly ridiculous. Exactly who is the ass in charge here? Which knucklehead oversees operations here? Has anyone within mental health got an actual brain in their head? Why on earth are they disputing Justina's diagnosis, furthermore, why have they held this 15 year-old girl prisoner for the last year?

Justina's parents are, today, holding a rally to create awareness about the abhorrent treatment of Justina and her incarceration at the hands of mental health buffoons who couldn't tell their own arse from their elbow.

Support is growing via the Protest for Justina Pelletier's Custody To Be Returned To Her Parents Facebook page and also via Twitter and other social networks.

Let's put things into perspective here.

Your child has a rare disorder. They develop the flu and you know that this could cause them problems. You take them to hospital because you are, obviously, concerned. Your child is then taken away from you, locked in a mental health unit and [we can only assume] drugged up to the eyeballs with drugs that can increase suicide, cause diabetes and that are highly addictive.

Let's hope these half-witted morons involved in the decision making are brought to task over their treatment of this young girl.

What an utter embarrassment.

Definition of hospital, by the way... an institution providing medical and surgical treatment and nursing care for sick or injured people.

...then mental health get involved.

Utter madness from these white-coated lunatics!

If you decide to retweet this story please use #FreeJustina as a hashtag.

Bob Fiddaman.

Related stories

Rally For Justina Pelletier This Morning At Boston Courthouse

Father So Heartbroken About Daughter Held at Hospital Against His Will He Just Defied a Judge’s Order to Talk to Us: ‘I Want to Have All My Guns Blazing’

UPDATE - Parents of Justina Pelletier upset after learning teenager will now be sent to DCF foster care

Thursday, February 20, 2014

Seroxat Implicated in Death of Musician

Derek Roger Smith (pictured) of Bridport was 65. He had been prescribed GlaxoSmithKline's antidepressant Seroxat. His body was found at the foot of West Bay cliffs last December.

The inquest into his death was, as we've come to expect with antidepressant related deaths, a bit of a sham.

No evidence that Smith had been prescribed Seroxat was entered into the inquest. Quite often a coroner will decide what evidence can or cannot be heard prior to the inquest. If he decided in this case that Smith's use of Seroxat was irrelevant then one has to ask why, something his partner, Annette Woolley, has done after an open verdict was issued at the end of the inquest.


An open verdict in an inquest is when the Coroner decides that the evidence given is insufficient to deliver one of the specific verdicts; natural causes, unlawful killing, suicide, accidental death or death due to industrial disease. However, if new evidence becomes available at any time which varies the verdict, the inquest can be re-opened.

Serious questions need to be raised here. Why did the coroner not allow the evidence of Smith's Seroxat use in, on what basis did he deem Smith's use of Seroxat was irrelevant to the investigation into his death?

The inquest focused on Smith's "mental health" issues  and how he had attended a mental health course earlier in the year, no further evidence was presented about his medical history or the drugs he had been given.

I find this utterly baffling given that the role of a coroner is that they have a duty to investigate the circumstances of sudden, unnatural or uncertified deaths that are reported to them. They have to find out the medical cause of the death, if it is not known, and to enquire about the cause of it.

How much effort would it have taken for the coroner in this case to enquire about Seroxat use and suicide? I mean, it's plastered all over the Seroxat patient information leaflet about the suicide risk and there have been many documented cases since the birth of this toxic drug.

Both GlaxoSmithKline and the British drug regulator, the MHRA, need to step up to the plate here. Glaxo, obviously have something to hide because Seroxat is manufactured and marketed by them. The MHRA are the 'independent' drug regulator who tell us what's safe and what's not. They have failed on a gigantic scale where Seroxat is concerned. Time and time again they have been bombarded with patient reports regarding the suicide link and Seroxat...they pass them off as being 'anecdotal'. If the likes of the MHRA won't come out publicly and slam Seroxat then coroners will take the side of the pharmaceutical industry, in this case, GlaxoSmithKline who, even after being found guilty, still deny that Seroxat causes suicide. [See Tobin v SmithKline Beecham Fig 1]

Fig 1

The above case clearly shows what the jury thought after hearing all the evidences put to them in the Tobin v SmithKline Beecham case.

Even after this verdict Glaxo still denied Seroxat [known as Paxil in the US] could cause suicide.

This would be like you or I being found guilty of a heinous crime and protesting our innocence. Only difference being...we'd be protesting our innocence behind bars. Glaxo shelled out $8 million for the above case. This after the decision was appealed by them and they were allowed to settle 'out of court'.

The coroner in the smith case said “Having looked at the evidence in this case, I am going to return an open verdict because I am not satisfied on the evidence I have before me that Mr Smith intended to take his own life.”

Too right he didn't...he was pushed over the edge, quite literally, by Seroxat.

Bob Fiddaman.

Wednesday, February 19, 2014

Paxil May Promote Breast Cancer

So, we know about Paxil and it's propensity to increase suicidal thoughts, we know it is a teratogen and has caused birth defects, we know that it has been the cause of completed suicides, we know that it causes severe withdrawal for many that try to come off it.

Surely we know all there is to know about Glaxo's toxic wonder drug? Apparently not.

A new study has identified paroxetine as having a weak estrogenic effect, which could promote breast cancer in women.

Don't you just love the folk over at GSK, what's the chances that they knew about this link and sat on it?

The Los Angeles Times ran the story yesterday.

Melissa Healy writes...

A team of researchers from the City of Hope in Duarte has developed a speedy way to identify drugs and chemicals that can disrupt the balance of sex hormones in human beings and influence the development and progress of diseases such as breast cancer.
In a trial screening of 446 drugs in wide circulation, the new assay singled out the popular antidepressant paroxetine (better known by its commercial name, Paxil) as having a weak estrogenic effect that could promote the development and growth of breast tumors in women.
Last summer, the Food and Drug Administration approved the marketing of a low dose of paroxetine  repackaged under the commercial name Brisdelle  as a nonhormonal treatment for hot flashes and other menopausal symptoms.

For more about the Paxil in disguise, Brisdelle, read Shionogi to Co-Promote Paroxetine Use in Menopausal Women

Nothing really surprises me anymore about Paxil. The only thing that really astounds me is that it's still being given a clean bill of health by drug regulators around the world. Mind you, when you learn that the drug regualtors are actually funded by the pharmaceutical industry it really shouldn't surprise anyone.

It's all about making money folks. So what if men, women and children kill themselves, so what if babies are born with limbs missing, so what if women are forced to abort their deformed children, so what if it causes horrific withdrawal what it it increases a woman's chance of developing breast cancer.

GlaxoSmithKline's corporate tagline is... GlaxoSmithKline is a global healthcare company that is committed to helping people to do more, feel better and live longer.

The British drug regulator, the MHRA, also have a laughable tagline... We protect and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

One word, four syllables.


Bob Fiddaman

Tuesday, February 18, 2014

GUEST POST - The Lundbeck Runaround

The following is a guest post from Cheryl Buchanan. Cheryl has previously written a guest post on this blog [link at bottom] - this is an update regarding her mission to seek the truth from Lundbeck, a Danish pharmaceutical company who manufacture the antidepressant citalopram, known by its brand name of Cipramil and known in the US as Celexa.

It's worthy to note that both citalopram and its sister drug, escitalopram, are both the subject of litigation in the United States. For further information please visit Forest Illegally Promoting Antidepressants for Kids!

GUEST POST - The Lundbeck Runaround

Back in December Bob Fiddaman very kindly invited me to write a guest post for his blob. I had contacted him after finding his blog while scouring the Internet for information about anti depressants and birth defects. I had just discovered that before, and during, the time of my first pregnancy in 2004 I had been prescribed the SSRI antidepressant citalopram. My daughter was born at 23 weeks gestation, she had multiple abnormalities and was incompatible with life.

Upon speaking to Bob I sadly discovered I was not alone and that there have been many women whose children developed birth defects in pregnancy while their mothers were taking citalopram and other SSRIs.

At the time I was assured it was safe and was wholeheartedly encouraged to keep taking it. I was on a very high dose (60mg) which is no longer prescribed as its known to cause long QT syndrome in adults.

It has now also been proven that it can cause birth defects, especially those related to the heart and abdominal wall. My daughter had no diaphragm and other abnormalities, all of the details are included in my previous guest post 

I have been in contact with Lundbeck to ask them a series of questions, in the beginning they were more that happy to accommodate, every email was replied to promptly. That was until the chat I had with Bob where we decided it was a good idea to copy Bob in on all the correspondence between myself and Lundbeck. It appears Lundbeck did not like this.

The first email I sent, with Bob cc'd, went unanswered. I waited a good few weeks but still nothing, I gave them the benefit of doubt and emailed again just in case they hadn't received it but yet again, no reply. Bob also told me that he had noticed an IP address he did not recognize had visited his blog, he decided to trace the IP and yep, you've guessed, it was Lundbeck in Copenhagen. By now I was getting majorly pissed. I decided to call Lundbeck and ask why they hadn't answered. This is the conversation that followed.

Conversation with Lundbeck employee 1.30pm 22/07/14

(CB - me, LU - Lundbeck)

CB - Hi can I speak to Ms Warrilow please?

LU - I'm sorry but she is not in today, it is anything I could help you with?

CB - Maybe you could but I'll have to explain the situation I'm in first.

LU - OK, go ahead.

CB - Back in 2004 I had a baby who developed severe abnormalities, she was incompatible with life and passed away at 23 weeks gestation. I was prescribed Citalopram at a dose of 60mg prior to, and during pregnancy. My GP knew I was trying to conceive and prescribed folic acid to me.

I was also told by more than one GP at my surgery that SSRI antidepressants were safe. I have a fair feeling citalopram caused my daughters birth defects. I had been in correspondence with Ms Warrilow who was answering some questions I had. We were in contact for several weeks but I have not had a reply to the last email I sent with a question, this was in December, or any subsequent emails asking why I was not being replied to.

LU - Oh, that's strange, maybe the question you had didn't have an answer. Why do you seem to think citalopram caused the birth defects, that's not a question there is an answer to, that's like asking if the sky is blue.

CB - I want to know because I am her mother and at the time no cause was found for her problems, she had normal chromosomes. I know from researching that SSRI's can cause birth defects.

LU - We recommend that the patient speaks to their GP, that is our guidance.

CB - I am way beyond "Speaking to my GP", I have had a meeting with the Clinical Director of the maternity hospital my daughter was born in, its in my records that he sent a yellow card warning to the Centre for Adverse Reactions in Scotland about the adverse reaction to Citalopram.

LU - When was this again, 2004, Oh I don't know if you will get any information, it was a long time ago.

CB - I have contacted the MHRA as my consultant contacted them. I wanted to ask if they had any information.

LU - The MHRA won't have any information, all reports are anonymous. I don't understand why you want to know, there is nothing that can give you a definitive yes or no.

CB - Would I be better contacting Lundbeck in Denmark directly? Or is there someone else I could speak to?

LU - Why would you want to do that, Eve already told you, we recommend you go back and see your GP.

CB - So all of this is my GP's fault for prescribing it?

LU - We tell the GP's to read the PIL, and the information we give them, and make their recommendations from that.

CB - But did the PIL or your information for GP's state the risk of birth defects in babies back in 2004?

LU - Oh we never recommend prescribing antidepressants in pregnancy, no studies have been done.

CB - There are other SSRI's, paroxetine being one, which is known to cause birth defects, I know citalopram is a category C, paroxetine is D.

LU - Oh, but we still do not recommend it in pregnancy.

CB - When will Ms Warrilow  be back?

LU - Tomorrow, what is your name and I will get her to contact you?

CB - Cheryl Buchanan, I have emailed a couple of times and had no reply.

LU - It must be the spam filter, we have been very busy and maybe just haven't gotten to your emails.

CB - It is possible its because I have copied Mr. Bob Fiddaman in on the correspondence? He has been giving me help and advice and has a lot of knowledge about SSRI's. He also has a blog and told me his blog has been visited a number of times by an IP he did not recognize, after checking it he found it belongs  to Lundbeck in Denmark so I think that you have been receiving my emails.

LU - I don't know anything about it. I will have Ms Warrilow contact you. Are you still taking Citalopram?

CB - No.

LU - Are you on a different SSRI?

CB - Yes but I am withdrawing from using it as I will not be a hypocrite and take something which more than likely killed my daughter.

LU - Are you doing this under GP's guidance.

CB - Yes. Thanks you for your time. Goodbye.

LU - No problem, bye.

I was dumbfounded. I awaited a response but once again was ignored. So I waited some more, just long enough for them to think I had gone away.

Then I called their head office again, this time the person who answered the phone was the one who I'd been speaking with by email.

Conversation with Ms W (Lundbeck) 17/02/14 - 4.30pm

CB - Hi can I speak to Ms Warrilow please?

LU - This is her speaking...

C - Hi, I am not sure if you know who I am but my name is Cheryl Buchanan, I was speaking to you through email a couple of months ago, about my daughters birth defects?

LU - Yes, I do remember

CB - I sent you an email back in December and I never got a response, I have since then emailed you several times and never got a reply.

LU - Oh, er, I think that was because there wasn't really anything else we could say to you.

CB - I understand that but it would have been more courteous if you could have replied telling me that, this situation is consuming my life at the moment and having to send repeated emails, with no answer, it doesn't help.

LU - Oh, yes, I do apologize.

CB - I actually called a couple of weeks ago and spoke to a colleague of yours, she took my details and assured me she would have you contact me.

LU - Oh, erm...

CB - I hope you understand I'm not blaming you personally, I know its absolutely nothing to do with you but a reply would have been helpful, even if to say you didn't have anything else to tell me.

LU - (Silence)

LU - The MHRA have been in touch with us, you asked in your email if they contacted us in 04, they didn't but have since, they might be able to help you. Would you like a copy of the information they sent us? It is anonymous but we figured it was you.

CB - I filled in another yellow card a couple of months ago and asked for them to contact me, I never got a reply, I imagine they have contacted you about the Yellow card I sent recently. If you could send me a copy of what they sent you I would really appreciate it.

LU - OK, that's not a problem.

CB - Can I ask a question? Do you know what the PIL stated about prescribing citalopram in pregnancy back in 2004, or could you find out? What I'm trying to figure out is if GP's would have known citalopram was a teratogen back then?

LU - I can get a copy of it, I'm sure it said use with caution but I can find out for you and send a copy of the 04 PIL to you.

CB - Do you know when the risks of prescribing in pregnancy were was added to the PIL, was it 2004?

LU - I'm not sure, the PIL changes all the time.

CB - I'm trying to figure out if GP's would have known Citalopram was a teratogen.

LU - I can get you a copy of the GP information and send it to you? I'm sure it would have said use with caution in pregnancy.

CB - That would be great

LU - Do we have your address, I don't think we do?

CB - No you wouldn't have, all our conversations were by email. (I give her my address)

LU - I will get that sent to you tomorrow, do you remember us sending you a permission form for you to sign so we can contact your GP?

CB - Yes but I don't have a printer so can't return it, could you send me a paper copy please?

LU - Of course, Ill get it send out to you along with the other information.

CB - Thank you for your time, bye.

LU - Bye.

While I had been awaiting a reply I decided to complain to the MHRA about Lundbeck's lack of response, just today they sent me a reply which seems to have been written by a robot and in no way at all answers the complaint I put to them.

Dear Ms Buchanan,

Thank you for your email regarding the lack of response from Lundbeck and your concerns regarding the product Citalopram. We are very sorry to hear about what has happened to you and your daughter.

Your email was treated as a patient report and we were as a consequence able to link this up with your previous correspondence with the Vigilance and Risk Management of Medicines Division.

In relation to Lundbeck your information has been passed to the Inspection, Enforcement and Standards Division who have responsibility for conducting Pharmacovigilance inspections of Marketing Authorization Holders (MAHs) such as Lundbeck. This information will be entered into the risk information system; this system is used to determine how often organizations are inspected. At such inspections we check how the MAH handles reports such as your own as they have responsibility for the on-going safety of products on the market. During any such inspection we do of course preserve the identity of any individuals such as yourself.

Once again, thank you for alerting us to this potential adverse reaction and the actions of the company.

Kind Regards,

Customer Services External Relations Medicines and Healthcare Products Regulatory Agency

Right now I am furious. This morning on my daily hunt of the net for info I was on Lundbeck's LinkedIn page. In the careers section their is a large photo header with the statement "Everyone deserves quality of life". How completley and utterly hypocritical. What about my daughters "quality of life"?

Because of a medication, made by them, which they knew in studies killed of the fetuses of pregnant rats and they marketed as being safe in pregnancy, my daughter is dead. She never got a chance of life. So Lundbeck, if you are reading this, please know that I'm not going to go away. I will keep doing my utmost to prove your are responsible for my child's and hundreds, possibly thousands, of other children's birth defects.

I have had several women come to me in the past few of weeks to tell me their story and how their children were born with birth defects after taking SSRI medication. I am not only doing this for my child, but for all the children whose lives have been damaged by your drugs.

To Bob Fiddaman, thank you from the bottom of my heart.

Back Stories

Citalopram Birth Defects (Guest Post)

The Lundbeck Emails [Citalopram Birth Defects]

Elementary, My Dear Dawson

Dr Dawson, I presume, is either getting his rocks off or away licking his wounds somewhere as he comes under fire from a number of patient advocates.

George Dawson, MD, a psychiatrist from the United States has, it appears, bitten off more than he can chew by responding to a blog post written by Peter Gøtzsche, who is a critic of antidepressant use and the pharmaceutical industry. I highlighted an interview with Gøtzsche a few weeks ago. [See Pharmafia: An Interview With Peter Gøtzsche]

Dawson took umbrage to most, if not all of the things Gøtzsche had written in his blog post, Psychiatry Gone Astray. The Gøtzsche post appeared on Dr David Healy's website and he has now, unwittingly, become a target of Dr Dawson.

It's Elementary school time folks and Dawson is shouting over everyone else because, well, isn't that what psychiatrists do when one questions the science behind their profession?

Dawson's critique of Gøtzsche's blog post was, as expected, one-sided. Dawson is very much in the pro-antidepressant use camp. His critique highlights his leaning toward drugging patients who suffer with a chemical imbalance, this is the same imbalance that has been poo-poohed many times by leading experts. Even pharmaceutical companies, who came up with the term originally, now have to admit defeat. Patient information leaflets now add the word "May" or "It is thought" in front of this speculation, an example being, "It is thought your depression is caused by a chemical imbalance".

Lets just look at the two blog posts of Gøtzsche and Dawson

Gøtzsche takes popular psychiatry beliefs and adds them to the myth pile, his first...

Myth 1: Your disease is caused by a chemical imbalance in the brain

Dawson responds with...

"This is a red herring that is frequently marched out in the media and often connected with a conspiracy theory that psychiatrists are tools of pharmaceutical companies who probably originated this idea."  He adds... "the alleged myth fails at the clinical level."

Dawson offers no concrete proof, just beliefs, which is, in essence, what psychiatry is all about.

Myth 2: It’s no problem to stop treatment with antidepressants.

Dawson responds...

"Another red herring.  I have trained psychiatrists, internists, family physicians and medical students and taught them psychopharmacology.  A general principle of psychopharmacology is no abrupt changes in therapy and most drug prescribing information suggests that.  I routinely address this issue as part of informed consent and advise people that there may be difficulty discontinuing antidepressants and describe the potential symptoms."  He adds, "It is quite easy to criticize if you are never faced with the prospect of discontinuing therapy."

Dawson kind of contradicts himself here. On one hand he claims that Gøtzsche's statement is a red herring then continues with  "there may be difficulty discontinuing antidepressants." So, not such a red herring after all then.

Dawson continues to critique all 10 of Gøtzsche's myth list. You can put them up side by side if you open the two links in different tabs in your browser. Gøtzsche versus Dawson.

Both Gøtzsche and Dawson have their supporters, this becomes evident when one looks at the comment section of each post. They make interesting reading and highlight Dawson's defence of his belief that antidepressants do not cause severe withdrawal.

A commentator, Altostrata, writes:

"As for antidepressants not being addictive -- this is a semantic argument."

Dawson responds...

"The idea that antidepressants and addictive medications is an irrational belief that I doubt I will be able to talk out of. I would recommend you abandon at least that part of it because it leaves you with a serious credibility problem..." 

So, according to Dawson, anyone who believes antidepressants are addictive are "irrational".

This statement in itself pretty much sums up the field of psychiatry. Here we have someone who believes in something because they have experienced it first hand. Because their belief doesn't fit in with the blinkered views of psychiatry, they are labelled "irrational".

Further afield, Irish blogger, The Truthman, has wrote about Dawson here. It's a great post as Truthman actually gets down to the nitty gritty of it all. He talks as a former patient and user of Seroxat [known as Paxil in the US]

Truthman writes in an open letter fashion to Dawson...

It is clear to me that your audacity and arrogance towards criticism of the profession goes beyond mere rebuttal, and disturbingly into the realm of utter derision. You have a total disregard for the views and the opinions of those you treat. Your psychiatric paradigm, and the ideology it contains, seems sacrosanct to you, this is dangerous, it is also gravely unwise.
The reason people like you are so dangerous is: you hold power and authority over extremely vulnerable people. Decisions you make about how a vulnerable patient is treated can literally mean the difference between life and death. Your hostility towards valid criticism (and the expression of that opposition) even from within your own profession, seems to matter more to you than compassion and proper care of the mentally (emotionally) ill. This is profoundly unsettling.
For me, at least, Truthman hits the nail on the head with one single paragraph...

I was prescribed Seroxat by a psychiatrist, the psychiatrist told me I had a chemical imbalance, my doctor told me that anti-depressants are like insulin to Diabetics, and that I would be on them for life. I was on them for 4 years, I couldn't come off them because if I did then I would hit a severe withdrawal. That may not be the classical definition of addiction but it was total dependence, the withdrawals were also horrific. Depression is not merely a cluster of symptoms, you are not the authority on it, depression sufferers are. Your profession is not the authority on mental and emotional despair and anguish, those that suffer its depths are!

Amen to that.

Dawson continues to defend his stance on antidepressant use and psychiatry... one wouldn't expect anything less.

Dawson, to my knowledge, hasn't yet been asked for his opinion on antidepressant use in pregnancy. I'd love to hear his blinkered views on this.

Meantime, this is for Dawson and his supporters.

It leaves me wondering [but not for long] if those featured in the video below all had a chemical imbalance and were all mentally disturbed in the way that psychiatry says they were. All I ask Dr Dawson is this... Is it just a coincidence?

Bob Fiddaman

Author of The evidence, however is clear, the Seroxat scandal

Monday, February 17, 2014

Quit Smoking the Safe Way - Glaxo Oppose.

So, I've been a smoker since the age of 14...I'm approaching 50 now so thought it would be a good idea to kick the habit.

Early in November I started using e-cigs, namely, the 10 Motive brand. You can buy them at Tesco, they are very cheap and still give you the nicotine hit. After three weeks I moved on to the menthol version and, I have to say, they have helped me a great deal. If I crave a cigarette now I just inhale on the e-cig - Job done.

They are still banned on most, if not all, airlines...this baffles me as no smoke is emitted from them.

There are rumours abound that the UK government are seeking to target the e-cig industry as more and more smokers switch to them - No surprise there.

On average a pack of smokes in the UK cost around £8.

With the e-cigs being considerably cheaper and the government losing revenue in tobacco you can see that these rumours may not be rumours after all.

Step in to the melting pot one GlaxoSmithKline. The British pharmaceutical company who just can't stay out of the news. If they are not denying their medicines kill people [babies included] they are covering themselves in garlands and boasting how they help third world countries. It's a bit like a serial killer giving money to charity. has opened a can of worms, they write...

Leaked correspondence between major pharmaceuticals company GlaxoSmithKline and EU regulators have revealed that the company is seeking harsh regulations against electronic cigarettes.  This comes as no surprise to many electronic cigarettes community members and business leaders who have long suspected major pharmaceuticals companies would view the products as a threat to their smoking cessation profits.

 Ecigadvanced quote The Times as the news breaker.

Let's look at the evidence.

E-Cigarettes, to my knowledge, have not caused anyone to kill themselves. They do not cause horrific withdrawal, they do not make you feel suicidal, they do not make you feel homicidal, they do not give you electric zaps in the head, they do not give you violent thoughts or visual or sleep disturbances.

Now, let's take a look at Glaxo's smoking cessation drug, Zyban.

First off, Zyban is a trade name. The active ingredient for Zyban is Bupropion.

When we look at the history of Glaxo's Bupropion we can see that it wasn't originally a medication to help people stop was in fact, and still is, an antidepressant marketed and sold by GlaxoSmithKline as one of its other trade names, Wellbutrin. [Don't you just love they way they use the word 'Well']

Let's just take a look at the side effects associated with Glaxo's smoking cessation drug/antidepressant.

This from the MHRA website. The MHRA are the [ahem] regulatory agency that safeguard us Brits from dodgy prescription drugs.

To date there have been a total of 20,469 reported reactions to Bupropion.

There has been 9,329 adverse reactions. Adverse means harmful.

And how many deaths have been linked with Glaxo's Bupropion?

Ah, just 83, a small number when one is conducting a mafia-like business.

There have been over 500 cardiac disorders reported with Bupropion use, 33 of which have been fatal.

Almost 4,000 Nervous system disorders reported with Bupropion use, 11 of which have been fatal.

670 Respiratory disorders reported with Bupropion use, 7 of which have been fatal.

The full list is available on the MHRA website, I'm unsure if this link will take you directly to the Bupropion drug analysis print, if it doesn't then interested parties can contact me by leaving a comment underneath this post.

The scandal doesn't end here. In fact it just gets better and better.

On the 21st December 2012 GSK, the company who pay fines and settlements whilst never admitting to any wrong-doing, paid $21.5 million to plaintiffs who had claimed that GSK had forced them to pay higher prices for antidepressant Wellbutrin SR, also known and branded as the smoking cessation drug, Zyban.

The settlement resolves [ahem] allegations that GSK violated antitrust, consumer fraud and consumer protection laws and made an unjust profit from the sale of Wellbutrin.

Way to go Glaxo!

For those who don't know, last year GlaxoSmithKline, the company that want us to believe that their violations are a thing of the past, entered a guilty plea into, amongst other things, the off-label promotion of drugs. One such drug was Wellbutrin. Glaxo were subsequently fined a massive $3 billion.

So, not only were they promoting this antidepressant cum smoking cessation drug to people it should never have been prescribed to, they were also forcing those buying it to pay higher prices.

More on the $21.5 billion settlement here [subscription needed]

Friend of David Cameron and Glaxo CEO, Andrew Witty is no stranger to Wellbutrin. I wrote about his involvement with Wellbutrin before.

Glaxo Wellcome'sVP-General Manager of Marketing Andrew Witty, as he was known between 1997/98, worked very closely with prescription drug ads on TV. This is known as DTC or Direct to Consumer advertising.

In August 1997 the US Food and Drug Administration [FDA] relaxed its rules on DTC, it basically meant that the FDA were giving carte blanche to the pharmaceutical industry whereby they could promote their products in TV ads without giving detailed medical information on the indications, potential side effects, or proper use.

Witty was quick to pounce. Why wouldn't he? DTC is lucrative for the pharmaceutical industry, well, it is in America and New Zealand as these are the only two countries that allow TV ads for prescription medication.

Witty added more products in 1997 with Glaxo's new anti-smoking pill Zyban, [buproprion] which got an estimated $55 million in support (the brand is even got TV teaser ads prior to its launch)

You see bupropion is used to treat major depressive disorder and seasonal affective disorder and it is also used to help people stop smoking by reducing cravings and other withdrawal effects.

So, in 1997, Witty pushed Zyban, Wellbutrin, call it what you will, onto the TV screens and into the homes of millions of Americans. He was in actual fact pushing an antidepressant onto an unsuspecting public.

Here's a Zyban ad from 1997, this is one that Witty would have been behind as Glaxo Wellcome'sVP-General Manager of Marketing. What I find remarkable about this ad is that they do not distinguish the two brand names as being practically the same. The only warning they off is, "Don't take Zyban if you are taking Wellbutrin" - Surely it would have been morally ethical to tell the consumer, "If you take Zyban and Wellbutrin together you will actually be overdosing on the active ingredient, bupropion." But hey, why would a pharmaceutical company, like Glaxo, wish to inform its consumers that a drug that could help you quit smoking was  really an antidepressant?

Glaxo never stopped there.

Back in 2010 GlaxoSmithKline associate general counsel, Lauren Stevens, was indicted with making false statements and obstructing a federal investigation into illegal marketing of the a 'drug' for weight loss.

That drug, ladies and gentlemen was Bupropion, Glaxo's antidepressant/smoking cessation drug. It's akin to giving athletes foot powder to someone with a headache. [Back story]

So Glaxo oppose e-cigarettes huh?

Well, I oppose their Seroxat birth defects, Seroxat suicides, horrific Seroxat withdrawal along with all their other drugs and vaccines that have harmed and killed men, women and children over the years.

Get your e-cigarettes won't be too long before the MHRA join forces and call for a ban folks.


According to GlaxoSmithKline's disclosure of contributions for the years 2009, 2010, 2011 and for the first two quarters of 2012, eight anti-smoking groups which have all called for a ban on electronic cigarettes received nearly $1.4 million during the period 2009-2012 from GlaxoSmithKline alone.

The contributions by organization are as follows:

American Cancer Society: $602,010
American Lung Association: $143,461 
Association for the Treatment of Tobacco Use and Dependence: $5,000
Campaign for Tobacco-Free Kids: $400,000
American Heart Association: $115,000
American Medical Association: $15,000
American Academy of Pediatrics: $65,075
American Legacy Foundation: $10,000

Total: $1.36 million [Source]

Bob Fiddaman

Sunday, February 16, 2014

The Boss Plays the Music of His CEO's

Bruce Springsteen is da man, the guy richly deserves all the plaudits. He's known as "The Boss", and rightly so. His music has inspired many, his concerts have sold out across the world. He is, without doubt, the main man.

Imagine my deep joy when a good friend of mine, and massive Springsteen fan, Arun Bhanot, sent me a link to a video of Springsteen opening his show in Adelaide.

Springsteen has been touring Australia and opening up his shows with AC/DC's Highway To Hell. Most of you will know I am a huge fan of AC/DC. In fact, chapter one of my book is subtitled 'Highway To Hell'

So, why am I writing about Springsteen and AC/DC on a blog that is predominently about pharmaceutical companies and piss poor regulators? Well, because even I need a break from all this dark, seedy stuff.

Writing and researching about the death of someone kinda takes its toll... so allow me to indulge.

Here's Springsteen covering AC/DC's Highway To Hell.

For Bon

AC/DC are set to hit the studio in May this year to record a new album. A 40 date tour will follow shortly after [source]

Bob Fiddaman

Friday, February 14, 2014

MHRA - "Your Views Matter"

I think it's safe to say that I, over the years I've been writing this blog, have had a lot of correspondence with the British drug [ahem] regulator, the MHRA.

Most of my correspondence with them, at least 80%, has been bog standard replies that they send out to anyone questioning their stance on antidepressants. I've publicly chastised them on here and in my book many times. Had a meeting with their CEO and met other officials on numerous occasions both in London and Birmingham.

Thing is... they've never really invited me to leave any comment about how I rate their performance.

Imagine my surprise then when I learn that they are now offering that service to members of the public who request information from them.

The MHRA Customer Services Feedback, aptly run via the surveymonkey website, invites you to leave comments regarding their performance of answering requests you have made to them. Hmmm, they have never offered me any such link in any of the emails they have sent me.

Anyway, why look a gift horse in the mouth. Armed with a snipping tool I've filled in the forms on the survey and added them as jpgs for your perusal.

The MHRA recently appointed a new CEO. His name is synonymous with Paxil litigation. Dr Ian Hudson took over the helm from Kent Woods last year. Hudson had previously been depositioned by US Attorneys in a Paxil suicide case. You see, the man who is now head of the MHRA once worked at GlaxoSmithKline, moreover, he was head of World Safety at GSK [Then Smith Kline Beecham] and worked closely with Paxil.

Nice to have some impartial at the head of a drug regulatory agency, huh?

Hudson, unlike Woods, chooses not to correspond directly with consumers [stakeholders], instead emails are answered by other employees at the MHRA.

Anyway...I've wrote about the conflict of interests at the MHRA many times before. Back to the The MHRA Customer Services Feedback.

Here's my feedback...

Bob Fiddaman


Another Boob From the MHRA

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"

MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine

MHRA - More on the Mysterious "Ghost Specialists" 

UK Drug Regulator [MHRA] Cosy Up to Sir Andrew Witty

Pfizer team up with the Medicines and Healthcare Products Regulatory Agency

MHRA: Disrespectful, Uncaring or just Downright Liars?

MHRA Described As "Toothless Watchdog

SEROXAT - The Legal Questions that must be answered

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part I of IV

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part II of IV - Witness For The Defence

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part III of IV - Expert Statistician

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part IV - The Colour of Money

MHRA Consultant Calls for Antidepressant Use in Young

Madison Holleran - The Needless Loss of Life

19 year-old Madison Holleran

19 year-old Madison Holleran had, it seemed, everything going for her. She was a promising scholar-athlete at the University of Pennsylvania. The burning question, and one that is being debated on social forums now, is why did Madison jump to her death from a Philadelphia parking garage on Friday Jan.17?

Pressures of trying to achieve has been batted around in many articles regarding the teen's suicide as has those two dreaded words "Mental Illness".

Madison's father, James Holleran, told the New York Post, "We knew she needed help. She knew she needed help," he stated. "She had lost confidence in academics and she also lost confidence in her track abilities."

James also shared the news that his daughter was also seeking help from a therapist in December after she had told her family that she had suicidal thoughts.

It's unknown, at this time, if Madison was taking any medication.

According to, Holleran had gone to Penn's counseling center for help and didn't like it, her father said. So her parents found her a therapist near home. She had gone several times, most recently on Jan. 10, the day before her father took her back to Penn.

"Her therapist said if you get a suicide plan in your head, you will call your dad, you will call your mom or you will call me," Jimmy Holleran said. "Madison said, 'I will.' "

The therapist recommended that Holleran take medication, and she made an appointment to see a doctor in Philadelphia, her father said.

It's difficult to comprehend what was going through Madison's mind when she decided to end her life. Many questions will be asked why she decided to call it quits. Pressure from school work, boyfriend troubles, fear of being labelled as someone who had a mental illness, fear of under-achieving...and many more.

Most of the articles I've read about Madison call for more input from mental health authorities. I couldn't disagree more.

I don't know what the relationship was like between Madison and her therapist but it didn't seem to prevent what Madison was feeling. If Madison's therapist had recommended she take antidepressant medication and Madison had complied then we have a whole new story on our hands.

If Madison was taking antidepressants would it have made any difference? Well, we know the first few weeks of treatment on antidepressants have to be carefully monitored due to the suicidal thoughts drugs such as Prozac, Paxil, Zoloft, Celexa, Lexapro, causing these thoughts in teenagers. What they basically do is numb you, they give you no fear, you don't think about the consequences of your actions whilst you are taking them...that's exactly what they were designed for.

Not one single antidepressant manufacturer can claim that taking antidepressants can stop a person from killing themselves. They do, however, have to warn that antidepressants may trigger suicide. Quite surprising then that there are calls for teens, as young as Madison, to seek mental health assistance. First route of mental health is medication.

My heartfelt condolences go out to Madison's family and friends.

Bob Fiddaman.


Madison Holleran laid to rest; was the track star on antidepressants? Dad at her Funeral: ‘We have to be strong’

Addressing suicide among seemingly successful college students

Thursday, February 06, 2014

Are Deaf People Immune From Schizophrenia?

I was just looking at the check list for schizophrenia. More often than not, "hears voices inside head" appears. It got me thinking.

If a person is born deaf they do not no what a voices sounds like...ergo they cannot ever hear voices in their heads.

So, are deaf people [those that were born deaf] immune from schizophrenia?

If yes, then surely this raises some serious questions when diagnosing, right?

Quite often psychiatrists label people who hear voices inside their heads as "schizophrenics". Find me a person who hasn't ever heard a voice inside his head [those born deaf excluded] and I'll dance naked in the street with peanuts adhered to my body. [Peanut Fetish Disorder PFD]

I've tried Googling the answer but can't come up with anything.

So, I guess this post will now fall into the annals of Googlesphere and when people Google the question, "Are Deaf People Immune From Schizophrenia?", they will end up landing on this post.

Ask a psychiatrist, if you know any one in that field... chances are they won't be able to give you a definitive answer, basically because their whole profession is based upon supposition rather than actual scientific fact.

Yet they hand out drugs based on supposition.

Calls for psychiatry to be abolished has [excuse the pun] fallen on deaf ears.

Bob Fiddaman

Wednesday, February 05, 2014

Christina Schumacher: An Update

Christina Schumacher told Vermont legislators on Thursday night that she opposes involuntarily hospitalization.

Regular readers will know that last month I wrote about the plight of Vermont's Christina Schumacher.

Schumacher had been locked up for 5 weeks or so [against her will] at the secure psych ward at Fletcher Allen Health Care in Burlington, VT.

Mental health assessors [armed with their crystal balls] had deemed Schumacher a danger to herself and others after she had recently learned that her 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.

Despite her protests, and the protests of close friends, Schumacher was held under duress and billed for the 5 week stay.

Here's the latest...

On Jan. 24 Vermont Superior Court Judge Kevin Griffin ruled that he could not find "by clear and convincing evidence" that Schumacher was in need of treatment when she was admitted Dec. 19.

Last week, during a two-hour joint session of the Legislature, Schumacher to lawmakers she had gone through hell the day she was admitted to Fletcher Allen Health Care in Burlington after learning about the killing of her teenage son by her estranged husband, who then killed himself. She added, "The bottom line is nobody should have to endure the death of their son and the death of their husband and then be put into the situation,"

USA Today takes up the story...

Schumacher said she was fortunate to have a lot of support from friends after the bodies were found Dec. 18, and she decided to keep her therapy appointment the following afternoon.
"I thought it would be a logical thing to do, to actually go to that therapy appointment," she said. "So I made a choice to go."
Schumacher said she was surprised to find that her therapist had been joined by the director of the counseling program, another doctor and two guards.
"They all made a decision before I even arrived that they were going to check me in. Check me into a mental health facility. A woman that just experienced the hell of her life," she said.
"That night I went through the fires of hell just dealing with what I dealt with," Schumacher said.
Schumacher said in an interview prior to the Senate hearing that she went public with her story in the Burlington Free Press while she was hospitalized to try to ensure nobody ever again has to endure what happened to her and also to be released so she could support her teenage daughter. Schumacher said her visit to the Legislature is a continuation of her fight.
The doctors told Schumacher they wanted her to take stronger drugs, she told lawmakers.
Once Lindsey Owen of Disability Rights explained to Schumacher her legal rights while she was hospitalized, she said she began to fight.
"I started standing up to the doctors," Schumacher said. "They did not know whether to kick me out or lock me up forever. So guess what? I fought for my rights, and I'm out of there."
"And no one should ever have to endure what I have gone through," she added. "It has been hell. I will not stop fighting this fight."

"The doctors told Schumacher they wanted her to take stronger drugs"

Since when has grief, or shock for that matter, been a mental illness?

This is yet another example of the white-coated jumped up little Hitler's wishing to play God...and failing miserably.

Thanks goodness Schumacher was able to show some fighting spirit. Who knows where she would be now if her natural instinct for survival had been suppressed by mental health services and the drugs they hand out like candy.

Heads should roll at Fletcher Allen Health Care in Burlington, VT.

This is for Christina Schumacher. She stood up to be counted... I salute her.

Bob Fiddaman

Tuesday, February 04, 2014

Shionogi to Co-Promote Paroxetine Use in Menopausal Women

Back in June last year I wrote about how the FDA had approved a rebadged version of Paxil for women who suffered hot flushes.

The unsuspecting public [women] will now be greeted with a perfect pink package with the brand name Brisdelle emblazoned on it.

So, how can a pharmaceutical company possibly promote paroxetine given it's horrendous side effect profile?

Simple...hire another pharmaceutical company to co-promote it for you.

Step forward Shionogi, a U.S.-based group company of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company. Their global mission? "Shionogi strives constantly to supply the best possible medicine to protect the health and wellbeing of the patients we serve." 

Shionogi's women's health sales force will now promote Brisdelle in the US to a range of healthcare providers, including some primary care doctors.

Wouldn't you just love to be a fly on the wall for this particular promotion?

No doubt Shionogi's managers will train their sales force well. You know, questions to avoid, how to use clinical information spin, how to avoid potential lawsuits, how to play down the side effect profile of paroxetine...etc. Maybe they could ask GlaxoSmithKline how they promoted Paroxetine use in kids and pregnant mothers before they were caught out by the authorities?

I'm going to cut and paste the post I did back in June last year. It pretty much sums up how Brisdelle could be promoted... and probably will be.

Saturday, June 29, 2013

FDA Approve Re-badged Paxil for Hot Flashes - By Bob Fiddaman

Those 'wise' folk over at the FDA in the US have gave the thumbs up for a new drug that's hit the market.

Brisdelle, marketed by Noven Therapeutics, LLC, is in fact a low dose of Paxil [Known as Seroxat in the UK and Aropax in the southern hemisphere].

The drug, which apparently treats moderate to severe vasomotor symptoms [that's hot flashes and night sweats to you and me] will be available in US pharmacies by November 2013.

Ah, the good old FDA approving Paxil yet again for conditions that will no doubt increase the risk of suicide and/or homicide in this patient population.

Brisdelle is a low dose treatment of Paxil, trust me, there ain't no such thing, any dose of Paxil is too much.

Noven Therapeutics claim that "At the unique low dose of 7.5mg of paroxetine as a mesylate salt, Brisdelle was specifically developed for and studied in women who experience hot flashes and night sweats associated with menopause." They add, "Brisdelle contains a lower dose of paroxetine than is indicated for any other condition."

Indications mean nothing, we all know that. This approval basically means Brisdelle will be prescribed for a whole host of conditions. It's perfect for pediatrics out there to prescribe off-label. Only 7.5mg you see, much safer, they will have parents believe, than a single 10mg tablet [currently the lowest single tablet dose]

Hooray, finally a treatment for something that is perfectly natural. I'm not scoffing at this problem, obviously I'm just a guy and, thankfully, I'll never have to experience something like menopause.... wait a minute...

Let's go back in time, just so I can show you how pharmaceutical companies work.

The website was launched in 1999. Here's what they were saying about male menopause. [1]

The existence of Andropause is now recognized by the medical world - including the Canadian Andropause Society - and by Canadians alike.
In fact, a recent Angus Reid survey found that 70% of the general public share the belief that men experience a mid-life stage similar to women's menopause. Andropause (also called "male menopause") is a normal part of aging; although, for some men it is accompanied by a gradual and undesired decline in their sexuality, mood and overall energy. Sometimes it can even expose men to more serious health risks.
As with women, Andropause begins at a time when life often offers some of its greatest rewards.

There was even an "Andropause Quiz" for males to take. [2]

So, what is Andropause?

Well, here's what the website told us back in 1999: [3]

By the time men are between the ages of 40 and 55, they can experience a phenomenon similar to the female menopause, called Andropause. Unlike women, men do not have a clear-cut external signpost such as the cessation of menstruation to mark this transition.
Unlike menopause, which generally occurs in women during their mid-forties to mid-fifties, men's "transition" may be much more gradual and expand over many decades.
Although with age, a decline in testosterone levels will occur in virtually all men, there is no way of predicting who will experience Andropausal symptoms of sufficient severity to seek medical help.

Medical help?

The website made claims that "Andropause was first described in medical literature in the 1940's. So it's not really new. But, our ability to diagnose it properly is."

By March 2002 the website changed in appearance and, in addition to explaining what Andropause was, they now had a treatment for it.


Hey, and if you wanted to know more about this treatment there was even a special website for you to read about it,

Here's how looked in 2002. [Fig 1]

Fig 1

Both and carried the copyright symbol of NV Organon.

By 2006 that symbol was clickable. You'd never guess in a million years where it led to? [Fig 2]

Fig 2

In fact, click on both links today and see where you are redirected to. Try them

Just cut and paste them into your browser. I won't hyperlink them because you need to do this for yourselves folks.

So, having covered the marketing of a drug to treat [ahem] andropause lets now turn our attention back to the 7.5mg Paxil pill, to be marketed as Brisdelle.

What you won't hear in the huge marketing campaign that will no doubt ensue are the side-effects to this drug.

This from the Brisdelle webpage:

Suicidal thoughts or actions:  
BRISDELLE, and related antidepressant medicines, may increase suicidal thoughts or actions within the first few months of treatment.

The website then goes on to tell us, "Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions."

But wait, Brisdelle isn't for depression or other serious mental illnesses is it?

They also warn you to call your healthcare provider right away if you have any of the following symptoms:

Serotonin Syndrome: Nervousness, hallucinations, coma, or other changes in mental status; coordination problems or small movements of the muscles that you cannot control; racing heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle rigidity; dizziness; flushing; tremors; seizures.
Bone Fractures: Women who take BRISDELLE may have a higher risk of bone fractures.
Manic Episodes: Greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual.
Restlessness: Women who take BRISDELLE may feel an inner restlessness, nervousness, or be unable to sit still or stand still especially when they start taking BRISDELLE.

The restlessness they refer to is more commonly known as akathisia.

Akathisia has been studied as the mechanism by which SSRI-induced suicidality occurs and can be reduced by withdrawing or decreasing the dose of the causative agent.

In other words, if you take Brisdelle it may induce your own suicide.

Most strikingly the makers of Brisdelle have gone out on a limb. It's a refreshing move. They write the following:

Do not take BRISDELLE if you:
Are pregnant. BRISDELLE is not for pregnant women. Paroxetine can harm your unborn baby.

Nice job Noven Therapeutics!

I've screen captured the above line for prosperity [Fig 3]

Fig 3

I'm unsure what clowns at the FDA granted license to this particular brand of Paxil. I can, however, be reasonably sure that more and more women are going to become addicted to this very powerful drug. But hey, don't worry about your addiction, that's easy enough to cure - just wrap a rope around your neck, pop a hose in a car, aim that gun at your head - Bang - addiction over.

Brisdelle [7.5mg of Paxil] is the new kid on the block.

I'm guessing that Noven Therapeutics pharmaceutical reps will have those cheque books ready to dine and dash those pediatric quacks and ask them to prescribe off-label. They may as well, every other pharmaceutical company who have manufactured SSRis have done it.

Bob Fiddaman

[1] [1999]
[2] Andropause Quiz [1999]
[3] What is Andropause? [1999]

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