Is Seroxat a Teratogen? : All in 15 Days work

Image: randi.org


It is important, before you continue to read on, that you read the first part of this particular correspondence with the Medicines Healthcare and products Regulatory Agency [MHRA] HERE

On the 5th of November, 2009 I sent an email to Sarah Morgan, Head of Pharmacovigilance Risk Management, at the MHRA. I also copied in Simon Gregor, Director of Communications at the MHRA. The question was short and sweet, Is paroxetine a teratogen?

[–noun Biology.
a drug or other substance capable of interfering with the development of a fetus, causing birth defects.] Source

Never in my wildest dreams did I think that this one simple question would cause such a disarray within the confines of the MHRA. A simple, yet very important question that would take 15 days to answer.

Before their response I'd like to give you a timeline of how the events unfolded.

5th November 2009:

I send an email to Sarah Morgan, Head of Pharmacovigilance Risk Management, at the MHRA. I ask her if paroxetine is a teratogen. I also copy in Simon Gregor, Director of Communications at the MHRA.

Later that day

I receive a reply from Simon Gregor telling me that Sarah Morgan 'may be away at the moment'. Simon tells me he has passed my email on to 'one of her colleagues, and asked them to identify someone else in the team that can reply.'

6th November, 2009

I ask Simon if he has had an answer back yet?

11th November, 2009

I remind Simon that I have still not had an answer regarding the paroxetine/teratogen question.

14th November, 2009

I email Simon about a different issue but add:
"Also, could you chase up the paroxetine/teratogen question. I'm quite baffled as to why such a simple question is taking one hell of a time to answer."

16th November, 2009

I email Simon Gregor, Sarah Morgan and Kent Woods the following:
Dear all,

I have gone ahead and wrote my thoughts on the paroxetine/teratogenic link.

Paroxetine - The Teratogenic Effect by Bob Fiddaman

A simple question I put to the MHRA could not be answered. Other regulatory bodies recommend that I talk to my GP, whilst GlaxoSmithKline cannot even be bothered to answer me.

Now, without the need for me wasting my time with a Freedom Of Information request:

Is paroxetine a teratogen?

Yes or no?

It's a simple question that requires a simple answer.

Regards

Bob Fiddaman

Same Day

Simon Gregor answers me with:

Dear Bob

Thanks for this - I know you followed this up with me on Friday, and I have asked for a status update today. I'll let you know as soon as I hear more, but let me reassure you that we are working on an answer to your question.

Same Day

I respond with:

Dear Simon,

What is there to work on?

It either is or it isn't?

Your lack of transparency over this is noted. I don't know whether you [MHRA] have to run it by lawyers first?

Imagine, if two weeks ago I was offered paroxetine by my doctor. Imagine if I was unsure about it. Imagine if I was a woman who was pregnant.

Simon, with respect, this is just not good enough. The MHRA have not gave me an answer yet and as you will see from my article nor have GSK or other 'bodies' I asked.

I'm glad I am not a woman who is pregnant.

I am off out for a walk now.

This is poor performance on MHRA's part Simon, very poor.

Same Day:

There seems to be some confusion regarding emails sent to and from Simon, he writes:

Dear Bob

I am catching up on emails, and apologies as I don't think I am answering them in the order you sent them.

Re the paroxetine/teratogen question, I emailed you this morning and had asked for a status update. A response is in hand and we aim to have it with you in the next few days.

Re warnings on paroxetine in pregnancy, I have a colleague researching this and again will come back to you as soon as I can.

17th November, 2009

I write to both Kent Woods and Simon Gregor with regard to an answer I had received from GlaxoSmithKline, same question, Is Seroxat a teratogen?

18th November, 2009

I write the following to Simon Gregor:

Simon,

This is getting beyond a joke now. My request was not under the terms of the FOI Act. It was a simple question that required a yes or no answer.

I would like to know what the MHRA's position is regarding paroxetine and the teratogen link.

Is paroxetine a teratogen?

19th November, 2009

Frustrated, disillusioned, I write the following to Simon, MHRA staff and other interested parties.

Dear Simon,

I think it's 14 days since I first asked the MHRA the question, Is paroxetine a teratogen?

If I have not had an answer by the end today then I shall reluctantly pull out of any further communication with you re: Patient and Public Engagement Strategy.

I will however still request information from the MHRA but will use the official FOI Act to do so.

One simple question that seems to have divided a wedge between all the hard work that has gone on to build bridges with myself and other patient advocates and the MHRA.

The question is not difficult, it requires a yes or no answer.

The reluctance of the MHRA to answer leaves me in no doubt that the whole system of adverse drug reporting is a total sham and that the MHRA are NOT doing enough to protect the public from harmful drugs.

No answer by the end of the working day and I shall request it under the FOI terms.

Regards

Bob Fiddaman

**A number of interested [and maybe not so interested] parties have been copied in on this email.

Same Day

I text Simon Gregor and tell him he has an email that I would very much like him to read. Simon texts me back and tells me he is out of the office and won't be able to access his email.

November 20th, 2009

Simon Gregor responds to email I sent yesterday [19/11/09]

Dear Bob

Following our text exchange yesterday, this is just to confirm that I have now had an opportunity to read your email. I can assure you there is no reluctance on our part to answer, and I am sorry if it has seemed that way. A response is being worked on, but in fairness I doubt it will be a one word response - we generally try to provide some background and context to what we say, and that is what colleagues will be working on. When I last checked with colleagues, I was given to understand that the response would be ready about now, so I will ensure that it is sent to you as soon as it is.

Same Day

I reply with:

Simon - is Seroxat an SSRi?

You know that I know the answer.

All I require is a simple yes or no answer to the teratogen question. I don't wish to be directed to such and such a link.

Once you provide me with an answer, I will forward you documents.

Meantime, read this - Is Seroxat a teratogen. GSK: "discuss your concerns with your doctor"

GlaxoSmithKline are, like you, also giving me the runaround regarding this issue.

I am not an idiot Simon and I don't wish to be treated like one.

You have til 6pm today


Later that day

Finally, the MHRA respond.

That response will be uploaded to this blog later.

Fid

SEROXAT SUFFERERS STAND UP AND BE COUNTED
Beware of Obsessive freaks posting as me


Original Image: whitman-ma.gov



"This petition is to bring criminal charges against GlaxoSmithKline. The medication they made has caused numerous deaths not to mention birth defects. Many babies have died or been born with horrible birth defects caused by the use of Paxil [Seroxat]. Information that Paxil caused birth defects was hidden therefore taking the right to make an informed decision was taken away from Mothers. GlaxoSmithKline needs to be held criminally accountable for their misinformation and blantant lies. It is for all these babies to have justice."

SIGN THE PETITION HERE

JULY 2009 SSRI WITHDRAWAL GUIDE BY DAVID HEALY

Response From MHRA - "Is Seroxat/Paxil a Teratogen?"

Image: randi.org


I first started writing this blog in 2006. I was basically frustrated at the lack of transparency coming out of the MHRA - My first post pointed to a story from 2004, it was, in essence, an article by Richard Brook giving the reasons as to why he resigned from the Expert Working Group who reviewed the safety of antidepressants.

Brook was then the CEO for the mental health charity, MIND, and he had accused the MHRA of failing in its duty by not acting on data showing that thousands of people were taking unsafe doses of Seroxat.

Brook said: "On Thursday [last week] the agency at last published information advising that many thousands of men and women in this country may have been taking Seroxat at a dose that was unsafe.

"What it failed to mention is that the regulator had the data on which the basis of this decision was made for well over a decade as part of the original licence application.

"Despite four major regulatory reviews during this period and considerable consumer reporting and disquiet, the Committee of Safety of Medicines failed either to identify or communicate these key facts. As far as I am aware, the MHRA has not seen fit to acknowledge or address what in my view appears to be extreme negligence."

The article grabbed my attention so it became my first post on this blog, I was, at the time, having my own difficulties with the MHRA, which became apparent with my second post, "YOU CAN RUN ... BUT YOU CAN'T HIDE PROF. WOODS".

For those who don't know, Prof. Woods is the CEO of the MHRA and I had wrote him regarding my concerns over the running of the MHRA and the antidepressant drug, Seroxat. Back then it would have been easier to get a personal response from the Pope as the MHRA were pretty much a closed shop.

Almost four years on and I have corresponded with the MHRA via email, telephone and in person - I even had my day with Prof. Woods where I raised concerns regarding the difficulties people were facing when withdrawing from SSRi's. I found Prof. Woods to be very charming. Here was a man that I had lambasted many times on this blog and he had the decency to meet with me. For that, he has my respect.

The outcome of that meeting is still on-going. The MHRA have met with Dr. David Healy, something I urged them to do at the meeting. Healy met and put forward his two penneth regarding SSRi withdrawal. [Minutes of meeting with David Healy]

More recently I have met and corresponded with Simon Gregor, the Director of Communications at the MHRA. Simon wished to seek my views on the MHRA's 'Patient and Public Engagement Strategy.' Simon has since met with other patients/advocates to ask for their views. Like Prof. Woods, Simon is a very charming man who listens carefully and appears to show great empathy.

As readers of this blog will know I have, over the past few weeks or so, been trying to ascertain whether or not Seroxat is a teratogen [Any agent that can disturb the development of an embryo or fetus]

The makers of Seroxat, GlaxoSmithKline, won't tell me, they claim:

"GlaxoSmithKline works within the guidelines set out in the Code of Practice of the Association of the British Pharmaceutical Industry (ABPI). This does not allow us to provide advice on personal medical matters to individual members of the public so that we do not intervene in the patient / doctor relationship by offering advice which properly should be in the domain of your doctor. We would therefore recommend you discuss your concerns with him or her."

It would appear that this clause is a useful tool for GlaxoSmithKline. If a patient or advocate queries one of their drugs they can pull down the shutters and 'pass the buck' to doctors. The Medical Information Department at GlaxoSmithKline told me, "We would reiterate that your own doctor is in a far better position to advise you and would recommend you discuss your concerns with him or her."

Very strange behaviour considering I had previously mentioned to the MHRA that too much onus is put on to doctors regarding SSRi's. See Notes of a meeting held at MHRA on 2 September 2008

"He [Bob Fiddaman] 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."

It would appear that GlaxoSmithKline like to drum home the point of talking to your doctor if you have a problem with one of their products, in this instance, Seroxat!

I have not yet received a definitive answer as to whether Seroxat is a teratogen. Glaxo can't/won't tell me, they guard themselves with the ABPI guidelines.

Before I post the response given to me yesterday from the MHRA over the 'Is Seroxat a teratogen' question, I'd like to point out that the very same guidelines that GlaxoSmithKline use to get out of answering questions about their drugs is supported by the MHRA.

Earlier this year the MHRA joined forces with the Association of the British Pharmaceutical Industry [ABPI] - the same body that protect GlaxoSmithKline from answering direct questions from members of the public, the same body that like to put the onus on doctors rather than the manufacturers of the products.

What I find quite bizarre is the quote from Prof. Woods at this joining of forces:

"Medicines can bring big benefits, but as with any medical treatment, no medicine is risk-free. By making as much information as possible publicly available, we can help people make informed choices about the medicines they take"

To coin a phrase, this stuff just writes itself!

Now, I would like the readers of this particular post to bear in mind the above statement of Kent Woods.

Over two weeks ago I wrote to the MHRA, it wasn't a Freedom of Information request, it was just a simple question.

Is Seroxat a teratogen?

Come back later to find out their response.

Fid

SEROXAT SUFFERERS STAND UP AND BE COUNTED
Beware of Obsessive freaks posting as me


Original Image: whitman-ma.gov



"This petition is to bring criminal charges against GlaxoSmithKline. The medication they made has caused numerous deaths not to mention birth defects. Many babies have died or been born with horrible birth defects caused by the use of Paxil [Seroxat]. Information that Paxil caused birth defects was hidden therefore taking the right to make an informed decision was taken away from Mothers. GlaxoSmithKline needs to be held criminally accountable for their misinformation and blantant lies. It is for all these babies to have justice."

SIGN THE PETITION HERE

JULY 2009 SSRI WITHDRAWAL GUIDE BY DAVID HEALY

The Story of GlaxoSmithKline The Company Contracted to Make Your H1N1 Vaccine

Just found this on youtube.

Here's the blurb from Sharp Edge Studios, who made the video:

"This video was made to be displayed at the University of Windsor in the CAW center one day before the H1N1 vaccine clinic opens on November 26th. It was made to inform the public about GlaxoSmithKline before they decide to get the H1N1 flu shot."



Fid

SEROXAT SUFFERERS STAND UP AND BE COUNTED
Beware of Obsessive freaks posting as me


Original Image: whitman-ma.gov



"This petition is to bring criminal charges against GlaxoSmithKline. The medication they made has caused numerous deaths not to mention birth defects. Many babies have died or been born with horrible birth defects caused by the use of Paxil [Seroxat]. Information that Paxil caused birth defects was hidden therefore taking the right to make an informed decision was taken away from Mothers. GlaxoSmithKline needs to be held criminally accountable for their misinformation and blantant lies. It is for all these babies to have justice."

SIGN THE PETITION HERE

JULY 2009 SSRI WITHDRAWAL GUIDE BY DAVID HEALY

Is Seroxat a teratogen. GSK: "discuss your concerns with your doctor"

Image: blog.prescriptionaccess.org


Part III of this on-going saga.



I've had another reply from GlaxoSmithKline regarding the question I put to them last week.

'Is Seroxat a teratogen'?

It appears from their response that my doctor is in a better position to answer my query, despite Glaxo manufacturing the drug?

First, their third email to me: [You will note that they have now removed the 'IMPORTANT NOTE: PLEASE DO NOT REPLY TO THIS EMAIL AS IT ORIGINATES FROM AN UNATTENDED MAILBOX' statement.

GlaxoSmithKline UK Ltd
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
Tel: +44 (0) 20 8990 9000
Fax: +44 (0) 20 8990 4321
www.gsk.com

19th November 2009



Reference Number: REDACTED

Dear Mr Fiddaman

Thank you for contacting the Medical Information Department at GlaxoSmithKline regarding our product Seroxat* (paroxetine). You asked whether Seroxat is teratogenic.

GlaxoSmithKline works within the guidelines set out in the Code of Practice of the Association of the British Pharmaceutical Industry (ABPI). This does not allow us to provide advice on personal medical matters to individual members of the public so that we do not intervene in the patient / doctor relationship by offering advice which properly should be in the domain of your doctor. We would therefore recommend you discuss your concerns with him or her.

We are, however, able to provide you with information from the UK Summary of Product Characteristics for Seroxat. Should your doctor require additional information regarding the use of Seroxat in pregnancy, we are able to provide this to him or her.

With regards to your question, Section 4.6 (Pregnancy and Lactation) of the UK Summary of Characteristics for Seroxat states the following:

“Some epidemiological studies suggest an increased risk of congenital malformations, particularly cardiovascular (e.g. ventricular and atrial septum defects) associated with the use of paroxetine during the first trimester. The mechanism is unknown. The data suggest that the risk of having an infant with a cardiovascular defect following maternal paroxetine exposure is less than 2/100 compared with an expected rate for such defects of approximately 1/100 in the general population.

Paroxetine should only be used during pregnancy when strictly indicated. The prescribing physician will need to weigh the option of alternative treatments in women who are pregnant or are planning to become pregnant.”

For further information, the Seroxat UK Summary of Product Characteristics is available at: http://emc.medicines.org.uk/

We would reiterate that your own doctor is in a far better position to advise you and would recommend you discuss your concerns with him or her.

Yours sincerely,

Medical Information Department
GlaxoSmithKline

*Trademark of GlaxoSmithKline UK Ltd

----

My reply:

Dear Medical Information Dept,

I would prefer a name in future correspondence, I don't think that is too much to ask, do you?

A couple of points before I respond to your email in depth.

Firstly, the original email you sent me, you claimed to have attached a response. Why did you make this claim?

Secondly, on each of the emails [with the exception of your last one] it is written clearly, 'IMPORTANT NOTE: PLEASE DO NOT REPLY TO THIS EMAIL AS IT ORIGINATES FROM AN UNATTENDED MAILBOX' -

If the mailbox was unattended, as you claim, then you would not have responded to me.

Now to your recent response:

Are you asking me to book an appointment with my doctor so I can ask him if paroxetine is a teratogen?

Do you not think this is a drain on NHS resources?

It's basically a simple question that requires a yes or no answer. If I were to enquire as to whether Seroxat was an SSRi would you refer me to my doctor?

It seems very strange that the company who manufacture a product are referring me to a doctor whose knowledge of that product is far less knowledgeable than yours?

The ABPI guideline is:

GlaxoSmithKline works within the guidelines set out in the Code of Practice of the Association of the British Pharmaceutical Industry (ABPI). This does not allow us to provide advice on personal medical matters to individual members of the public so that we do not intervene in the patient / doctor relationship by offering advice which properly should be in the domain of your doctor. We would therefore recommend you discuss your concerns with him or her.

I am not seeking advice on a 'personal medical matter' and am currently not seeing a doctor for any illness, nor am I pregnant - as far as I know, men cannot fall pregnant, though I'm sure sometime soon there will be a miracle pill or vaccine that will put that right.

Forgive me for my flippancy.

Don't you think GlaxoSmithKline have a duty to warn patients as to whether or not one of their products is teratogenic? - If not the patients then maybe the Medicines regulator [MHRA].

Didn't Dr. Sparenborg, a toxicologist, who saw your original rat tests on Paxil [Seroxat] say that GSK needed to conduct further animal studies to account for so many deaths in the original rat studies?

According to trial transcript 9-15-09 Opening Statements - GSK declined to do the additional safety studies due to concern that they would move to the more adverse pregnancy category C while their SSRI competitors would share category B. This despite GSK scientist Dr. Wier, a teratologist, internally saying Paxil [Seroxat] should always have been a category C due to original animal studies deaths.

Would I be right in saying that All SSRIs except Paxil, are now classified as Category C medications, meaning they should only be used if the potential benefits outweigh the potential risks?

Would I also be correct in saying that since 2005 Paxil [Seroxat] has been classified as a Category D medication in the USA - in other words:

“Positive evidence of risk-studies in humans,” which means fetal risk has been demonstrated. “Nevertheless, potential benefits from the use of the drug may outweigh the potential risk. For example, the drug may be acceptable if needed in a life threatening situation or serious disease for which safer drugs cannot be used or are ineffective.”

Source


With the above in mind, do you think I should guide my doctor to the UK Summary of Product Characteristics for Seroxat or maybe guide him to the various testimonies from the recent GSK v Kilker trial. I'm a firm believer in transparency, you see and I think it only fair that my doctor know ALL the facts before prescribing Seroxat to a woman with child. Do you think that's a fair statement to make?

Furthermore, you suggest in your response that 'Should your doctor require additional information regarding the use of Seroxat in pregnancy, we are able to provide this to him or her.' Will this additional information include any of the above?


Finally, in the last para of your response you write:

"We would reiterate that your own doctor is in a far better position to advise you and would recommend you discuss your concerns with him or her."

I find this quite difficult to grasp, seeing as many of your employees have spoken in the media about the benefits of Seroxat, does GlaxoSmithKline not wish to discuss the risks with me? I already know of the 'benefits', I've read the Patient Information Leaflet.

Judging by your three replies to my initial query, 'Is Seroxat a teratogen', you are saying that my doctor will know the answer to this? Is this your position?

I understand that my in-depth response is rather long and suspect I have raised points that you may not wish to discuss with me.

For the record, I would like a response.

Regards

Bob Fiddaman

----

Related posts:

Paroxetine - The Teratogenic Effect by Bob Fiddaman

GSK Response to Teratogen question - Laughable

The GSK Teratogen Plot... Thickens!

Fid

SEROXAT SUFFERERS STAND UP AND BE COUNTED
Beware of Obsessive freaks posting as me


Original Image: whitman-ma.gov



"This petition is to bring criminal charges against GlaxoSmithKline. The medication they made has caused numerous deaths not to mention birth defects. Many babies have died or been born with horrible birth defects caused by the use of Paxil [Seroxat]. Information that Paxil caused birth defects was hidden therefore taking the right to make an informed decision was taken away from Mothers. GlaxoSmithKline needs to be held criminally accountable for their misinformation and blantant lies. It is for all these babies to have justice."

SIGN THE PETITION HERE

JULY 2009 SSRI WITHDRAWAL GUIDE BY DAVID HEALY