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Wednesday, April 06, 2016

10 Years of Blogging - Q&A With Neil Carlin

Today marks the 10th anniversary of this blog. What started as a gripe against the British drug regulator (MHRA) has led me on a journey, one that I could never have dreamed of.

In 2010, four years into blogging I was at a bit of a stalemate, I was finding it increasingly frustrating trying to get the answers from both GlaxoSmithKline and the MHRA as to why I suffered at the hands of Seroxat. Neither of them, to this day, have ever been able to answer me.

Then it happened. The start, or rather the change in direction of this blog of mine.

I stumbled on a post from Canada. A young woman, known as Sara Carlin, had hit the news ~ her parents were seeking an inquest into her death, a suicide in 2007 - May 6 to be precise.

The date is significant as I will mention later.

I reached out to her father, Neil, and we were soon communicating. Sara, his daughter had been prescribed the very same drug that I was asking questions about ~ Seroxat (known as Paxil in Canada)

In 2006, a year or so prior to her death, Sara had been to see her doctor (Dr Stanton) who had diagnosed her with panic disorder and depression. This, he claims, was based on a 30-minute visit to his medical office. Sara, he claimed, had told him that she was having trouble sleeping, that she was having lots of nightmares, that she had no energy and was feeling very negative and depressed.

Sara was prescribed Paxil. She, at the time, was just 17 years-old.

Sara's parents, Neil and Rhonda, were not told.

The possible increased risk of suicide with Paxil usage was not mentioned by Dr Stanton either.

What happened over the course of a year or so is well documented on this blog (just type Sara Carlin in the search box at the top left of this blog)

Neil and I became quite close during Sara's inquest, an inquest that, I believe, was incredibly biased into protecting GlaxoSmithKline and its antidepressant. Remarkably, the press just couldn't see the protective cloak thrown around Paxil during Sara's inquest, this despite the coroners lawyer, Michael Blain, going in front of TV camera's on day one of Sara's inquest and announcing that the court "don't think that the medication played a role in Sara Carlin's death" (Video) ~ This before her inquest actually started!

Furthermore, at the end of her inquest the jury was told that they could not name or blame any party in this inquest, including the three doctors from Oakville, Ontario Canada and the drug company GlaxoSmithKline.

Despite these restraints the 5 person jury returned with a list of 16 recommendations, including...

  • An arm's-length body independent from Health Canada dedicated to drug safety funded by the federal government with no money from drug companies with mandated responsibilities to research drug safety, investigate adverse reactions and issue warnings to the public, health-care professionals and hospitals.
  • A standard, plain language information leaflet for patients filling a prescription that includes what the medication is for, its risks, under what conditions the drug should not be taken, interactions, proper use, side-effects and what to do about them.
  • Mandatory reporting by health professionals of serious drug-related adverse events to Health Canada.
  • A provincial-wide suicide prevention strategy, such as Alberta has done.
  • Guidelines and training for family physicians on prescribing selective serotonin reuptake inhibitors or SSRI antidepressants.

Fair to say then that despite the restrictions placed on them, the jury were in no doubt certain about the cause of Sara's death.

Neil and I had an emotional conversation on the final day of the inquest and the following year we both finally met in Canada. I was introduced to his wife (Sara's mom), Rhonda, and they both welcomed me into their family home. We laughed, we cried. I even spent time alone at Sara's final resting place.

I've always had this connection with Sara, maybe it's because Sara, played a significant part in how I, as a writer, changed my direction as a blogger/activist. ~ Sara showed me the bigger picture, if you will.

Neil and I have remained in touch all these years and although we don't talk as much as we used to we still have a tremendous bond. I hope one day to travel to Canada again so I can spend more time with both he and Rhonda.

The significance of the date of Sara's death May 6, 2007, may not mean a lot to readers.

On May 6, 2012, exactly five years after Sara's passing, my eldest son phoned me to tell me that his wife had given birth to a baby girl.

They called my granddaughter Ruby-Rose, she, just like Sara Carlin, is, and always will be, a gem and a symbol of life.

Here's Neil's Q&A...

Full name: Neil Patrick Carlin
Age: 64
Location: Simcoe County, Ontario, Canada

Q: Neil, as you know Sara has played huge role in putting my blog on the map - My hits went into overdrive when I was reporting on her inquest and really changed the direction of my thinking with regard to writing about the whole pharmaceutical/regulatory aspect of things. It was a tough period in your life, Rhonda's too. Can you tell me a little bit more about the outcome of Sara's inquest and if recommendations made have been implemented?

A:  Thanks Bob. We truly appreciate your hard work in letting people know what was happening at her inquest. Rhonda & I are forever grateful.

There were 16 recommendations from the jury all of which we thought were quite good – a couple of them were ours. (I think you covered them quite well in one of your past blog posts so I won’t list them here) but to the best of my knowledge none have been acted upon as of this time. In Ontario, as in most parts of Canada, there is no legal requirement for a party to even acknowledge a recommendation directed at them. They do not have to respond in any way to any government agency, which seems to make a sick joke of the whole process. This issue was covered quite extensively in a series of well written articles by Doug Quan of the National Post in 2014 – Dying to be Heard. Rhonda & I were interviewed for that series with a video included at the link for those interested. (1)


Q: Have you at any point corresponded with Paxil manufacturer, GlaxoSmithKline, with regard to Sara's Paxil induced suicide or have they ever apologised for the role Paxil played in Sara's induced suicide?

A: No to both questions. We never even received any condolence from any of the doctors involved in Sara’s care.


Q: Since I've known you, you have always had a grasp on the role of how metabolism works with regard to antidepressant use. Can you, for the benefit of the readers, explain this in layman's terms?

A:  Wow, that is a big order. You really do ask tough questions. It is a complicated process that I’m still learning about, but here’s my lay person’s explanation.

Metabolism is the process of removing toxins from the body including drugs (pharmaceutical or illicit). Psychiatric drugs including antidepressants are usually formulated as fat soluble agents so they can easily cross the Blood-Brain Barrier to exhibit their targeted effect.  For complete elimination, primarily in urine & stool, they must be reduced to inactive metabolites that are more water soluble. This process occurs mainly in the liver and begins with phase I oxidative metabolism by one or more of the CYP enzyme systems or P450 enzymes as they commonly called. There have been dozens of these enzymes identified to date, although only six are thought to be responsible for most of human phase I metabolism. SSRI antidepressant drugs extensively use these enzymes, often in combination. Two areas of importance regarding drug metabolism are 1) Genetic variance in expression of these enzymes – i.e. polymorphisms. 2) Drug-drug interactions.

Paroxetine (Paxil , Seroxat, Aropax), as an example, primarily uses the P450-2D6 enzyme. Its, what’s called, a substrate of 2D6. Somewhere around %10 of the Caucasian population are, genetically speaking, considered to be 2D6 poor metabolizers - they can’t make or synthesise it in significant amounts and may experience adverse effects (because of higher than usual blood concentrations) at low or so-called normal doses.

The other big problem with paroxetine, as I see it, is that as well as being a substrate for 2D6 it is also a potent inhibitor of the enzyme. So as dosing increases, paroxetine will paradoxically shut down synthesis of its own primary metabolic pathway (2D6) resulting in what is called non-linear pharmacokinetics, which simply means that, for example, doubling the dose may more than double the circulating blood concentration. Paroxetine seems to be the only SSRI medication that exhibits this effect, at least to the degree that it does. Some will say that this is not terribly important because paroxetine has large therapeutic range. I don’t buy into that argument because if you increase anything to a large enough level something will eventually break. See this article - 'Higher Antidepressant Doses Increase Suicide Risk for Young Patients' (2). This might explain, in part, why paroxetine has been significantly associated with teenage suicide.

You can also get into significant drug interactions because of competitive inhibition - where paroxetine hogs the 2D6 enzyme pushing other drugs off. The pro drugs (where the major metabolite is the active agent) Codeine & the breast cancer drug Tamoxifen are two good examples of other drugs that need 2D6 and can be rendered ineffective by paroxetine.

That’s about as short an explanation I can give.

Q: Spending time with you and Rhonda was, for me, one of the highlights of the past ten years, truly great company. You and I both went to visit Conservative member of the Canadian House of Commons, Terrence Young. Can you tell me the role Terrance has played with regard to stringent warnings being place of prescription medication in Canada?

A: First off, I wish to say that Terence is a great man who has been and continues to be a good friend and staunch supporter of our family.

As you know, Terence testified at Sara’s inquest on the then current state of prescription drug approvals & adverse event reporting/ handling by Health Canada. He did not have anything good to say. He told the jury that Canada badly needed an independent Drug Safety agency to protect patients.  The jury listened to him and recommended that the government of Canada develop an independent (from Health Canada) Drug Safety organization.  At that time Terence was a sitting MP on the government side and his Minister of Health eventually helped usher through new legislation aimed at beefing up Health Canada’s post-market pharmacovigilance program. This was eventually passed into law and named Vanessa’s Law in memory of his late daughter who died of a prescription drug (Prepulsid) adverse event when she was a young teenager. I know there was a process developed toward implementation of these changes in the law and at this point I can’t tell you exactly where that whole thing presently sits or if it has yet to have had any significant impact on prescription drug safety in Canada.


Q: Both you and Rhonda appear in Kevin P. Miller's new movie, 'Letters From Generation RX'. What do you hope that this movie achieves?

A: First off I want to tell you what a wonderful human being Kevin is. The man is a genius with a tremendous empathetic capacity for human suffering. I don’t know how someone can have such unwavering dedication & tenacity for a cause with so many grim stories. Having said that, I think Rhonda & I just wanted to be a part of the message that we think Kevin is trying to deliver. That is, for people to be very cautious regarding psychiatric drugs, and that there are alternative treatments available. Also, that people, being fully informed, should to take their health care decisions into their own hands.


Q: Many people won't know that you're an avid guitar player. Can you tell me about the guitars you own and if you have written material for songs?

A: I’m down to a few of my favourites. I have a beautiful Marc Beneteau handmade acoustic guitar I bought nearly 20 years ago when my eldest daughter started taking lessons (and yes it is difficult to teach your own child how to play). Also a Gibson Marauder electric I bought 40 years ago when I was playing in a part-time bar band. A big 40 year old Ventura 12 string with great sound that I got on a trade. A very nice Godin Freeway bass guitar and a Cort classical guitar that is great for finger picking. I have several songs I’ve written over the years. One of my goals in retirement is to re-start my little digital recording studio (a computer with a good sound card and a couple of microphones) and to record them, just for fun of it.


Q: Would you recommend blogging to parents, or anyone for that matter, who had lost someone dear to them through antidepressant induced suicide?

A: I don’t blog so that is probably not something I might suggest. I would only say that they should find something, anything that helps get them through in a non-destructive way. Loss of a child under any circumstance is a horrific loss to suffer through. Suicide has its own challenges and it takes a lot of time to get back a just little bit of your life as you knew it.


Q: Difficult question, but what is your fondest memory of Sara?

A: Yes, that is a tough one as there are many, but I will say that watching her gracefully skate when playing ice hockey is one of my fondest. She started figure skating at age 5 and by 11 made hockey style skating look easy. She could skate backward faster than most could forward.


Q: Have you ever considered writing a book about your journey?

A: I have thought about it but I doubt I ever will. We now have our first grandchild and I want to stay focused on family. However, I would consider doing short pieces on specific topics. In any case, I’m not a naturally skilled writer as are some people I know.


Q: What do you say to people who believe that antidepressants are safe and effective?

A: There is really nothing much I can say if people have no ability to think critically about the harms and benefits of antidepressants or any pharmaceutical drug. If someone believes that medications are significantly improving the quality of their life then I’m glad for them. I will tell them that they are one of the lucky ones.


Q: What advice would you give to Coroners faced with suspected suicides of teenagers?

A: I highly doubt that the Office of the Chief Coroners of Ontario (OCCO) would listen to any advice from me. I’ve tried, believe me.

But I would tell them that they should be doing a proper investigation without just signing off on paperwork. I firmly believe, at the very least, confirming post-mortem toxicology should be done in every case of suicide – not just teens and not only in cases of suspected overdose. Violent suicide should be a red flag for psychiatric-drug-related death. An autopsy with collection of femoral vein blood is now routinely done in these cases.  Toxicology should be done in every case of sudden death in a young person.  The Swedes routinely do it so why can’t we?

The cardio-toxicity of citalopram & its derivative s-citalopram is a good example of a drug that can cause sudden death that is not a suicide. The information gathered through on-going toxicology and post-mortem examination may help the understanding of how prescribing practices affect public health/ safety. The OxyContin ® disaster comes to mind here.


Q: What advice would you give to parents whose children/teenagers are on antidepressant medication?

A: Watch carefully for untoward changes in behaviour and contact the prescriber if the drug is not helping or appears to be making their teenager worse. If the doctor won’t listen (as in Sara’s case) find another doctor who will (which we did not because of lack of knowledge). The reality is that by the age of 16 years doctors can prescribe anything to teens without parental knowledge or consent. There is not much a parent can do except to contact the doctor/s and threaten them with a complaint to their professional regulator.


Q: For you, what is the most frustrating part about the coronial system?

A: Well at least here in Ontario, coroners must legally be medical doctors. The chief coroner routinely uses family doctors as investigating coroners in their own communities, on a fee for service basis. I think this leaves a serious potential conflict of interest when it comes to these coroners investigating the death of their colleagues’ patients or the investigation of deaths in the hospitals where they may work on rotational ER duties.  I often wonder who investigates the death of one of their own patients?

There was an attempt to overhaul the Ontario death investigation system in 2012 – a recommendation that came out of the Goudge Inquiry -  but that was successfully beat down (3). There appears to be no political will to overhaul the Ontario death investigation system.


Q: Where do you see yourself in 10 years time?

A: Hopefully above ground and vertical. But seriously I want to be an active granddad still playing rock n roll and enjoying the things I do. But I know how precarious life is so I don’t think too many years ahead.


Q: Finally Neil, some personal questions...

1. What book are you currently reading?

A: The Emperor of all Maladies: A Biography of Cancer by Siddhartha Mukherjee.

His section on tobacco-related lung cancer is quite interesting. The tactics used by the by the pharmaceutical industry today seem to be identical to the ones used by the tobacco industry decades ago. Which are to deny a causative link by stating, as often as possible, that “association does not equal causation”, and then hire academic shills to publish scientific literature to support that position, while at the same time spending millions on advertising. They learned the lessons well.

2. What was the last CD you listened to (in full)?

A: A few months ago - Crosby, Stills & Nash – their self-titled debut album, released in 1969 during my first year in college. There is a track on that album called Long Time Gone that I have always especially liked and wanted to learn to play & sing. It was a Vietnam protest song but I think the lyric lends itself to what is now happening with the psychiatric drugging of children. You should probably have asked what was the last full CD I’ve listened to that is not more than 40 years old.

3. What is the best movie you have seen this year?

A: It is always difficult to pick a best of anything, but if I must I would pick The Revenant starring Leonardo DiCaprio. Without giving away any of the plot, I will only say that I think it is a story about a man who’s driving force for survival was retribution. Something I can relate to.

4. What country would you most like to visit?

A: Scotland, where I was born.  My parents immigrated to Canada when I was 5 years old and I’m the only one in my family who has not been back for a visit. Besides my wife Rhonda is a fan of the TV series Outlander and wants to see the highlands. I would include Ireland in that trip, because that’s where my ancestors are from.

5. If you had the choice of being either a defence or prosecution lawyer, which would you choose and why?

A: A criminal defense lawyer. I believe that the good ones are true advocates that keep the justice system honest. Without them we would have many more wrongful convictions. The very best are highly skilled in the art of cross-examination, especially of lying police officers.

(1) Dying to be heard: Families, safety advocates often frustrated at lack of action on inquest findings

(2) Higher Antidepressant Doses Increase Suicide Risk for Young Patients

(3) Ontario coroners to retain control of death investigations

Bob Fiddaman.

For Sara
Nessun dorma