Yellow Cards

Too funny: this is a real bonus, because I wasn't expecting a reply to my original message. "The benefits outweigh the risks". Not for me, they fucking didn't, Mr Phul, and I would have appreciated being told that I could have had the benefits, without the risks, by exercizing for an hour, three times a week, or with psychotherapy. The MHRA's Great Words of Wisdom are in bold, as usual:


Dear Mr Phul,

Thank you for taking the time to respond, although it is something of a non-answer, from my perspective. SSRIs are a placebo substitute (given their level of efficacy), but have extreme side effects, which are acknowledged. It is regrettable that the Worshipful Company has chosen to profit from the fact that it is regarded as unethical to prescribe placebos.

Please do not express your regret at my experience. First, because you do not know what I have experienced (and thus you do not know what you are apologizing for), and second, because it is evident that you have no intention of seeking an understanding and making redress. What I experienced is not acceptable, irrespective of the pharmaceutical industry's lack of understanding of mental illness. The lack of concern that has been demonstrated subsequently, by all interested parties, merely suggests to me that not only are those parties determined to lock down their own position, but also to ensure that it is made clear to me that the only possible explanation for my experience is down to me. In other words, the MHRA, with others, is justifying what happened to me. I think you understand how I need to respond to that.

For the record, I do not accept that interpretation of events. Unpleasant as it is to conceive, the logical, alternative explanation for my experience is that the MHRA (and others), is incompetent. There are many factors that contribute to this being an reasonable alternative explanation, not least because it is apparently driven by the marketing concerns of the industry (which is itself marketing-led), that it purports to regulate. When an organization's culture is geared towards sales and marketing, compliance tends to go out of the window, in my experience.

When the MHRA speaks as freely to patients as it does to the companies it regulates, I will review my position. The problem is still Ms Raine's.

Best regards


Matthew Holford

********************************
Subject: Re: Yellow Cards
Date: Thu, 21 Feb 2008 13:43:13 +0000
From: [redacted]@mhra.gsi.gov.uk
To: [redacted]@hotmail.co.uk


Dear Mr Holford,

Thank you for your recent e-mail to Dr Raine regarding your concerns about fluoxetine and the side effects you experienced. I have attached a response to this message.

Kind regards

[redacted], BSc (Hons) Ph.D
Senior Pharmacovigilance Scientist
Vigilance and Risk Management of Medicines
Medicines and Healthcare products Regulatory Agency

Attachment:
Dear Mr Holford,

Thank you for your recent e-mail to Dr Raine regarding your concerns about fluoxetine and the side effects you experienced. I have been requested to reply on her behalf. I am sorry to hear of the problems you have had since taking this medicine.

I understand you have been in correspondence with other colleagues in the Agency and we have noted your concerns regarding the use of SSRIs and I would like to assure you that as with all medicines, the safety of fluoxetine is closely monitored by the Medicines and Healthcare products Regulatory Agency/Commission on Human Medicines to ensure that the benefits of this medicine outweigh any potential risks, and when evidence of a new safety issue comes to light, appropriate action is taken.

Thank you again for contacting us and taking the time to fill in a Yellow Card, your contribution to the scheme is important.

Yours sincerely

[redacted]
Senior Pharmacovigilance Scientist
Pharmacovigilance Information Unit
Vigilance and Risk Management of Medicines
Room 15-208
cc: [redacted], Pharmacovigilance Information Unit Manager

********************************
From: Matthew Holford
Sent: 18 February 2008 13:26
To: Raine, Dr June
Subject: Yellow Cards


Dear Ms Raine,

I understand that the following quotation is attributable to you:

"If you suspect that you have had a side-effect to your medicine, please tell us about it via the Yellow Card scheme."

I have filled out a Yellow Card report, as it happens, but I'll tell you about the side effect that I experienced consequent to using fluoxetine, too. It made me suicidal. I think it was the sense, as I paced in between my front room and kitchen, unable to settle, like a hunted animal (I believe this is known as akathasia), that it would never end. And that nobody cared, either. Do you care (servant) Raine? Really? How about you (servant) Texture? (servant) Johnson? (servant) Vara? Anybody? No, I didn't think so.

There: I've told you about it. Now, it's your problem.

Best regards


Matthew Holford