Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Showing posts with label Health Canada. Show all posts
Showing posts with label Health Canada. Show all posts

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

Wednesday, March 16, 2016

Letters from Generation Rx - A Review





**Update April 7
The movie is now available to watch - see trailer at the foot of this review.

I was fortunate enough to be sent an advanced copy of Kevin P. Miller's groundbreaking new movie, Letters from Generation Rx, earlier this week. I pretty much knew that it would sadden me. I pretty much knew that it would, at the same time, make me angry. I wasn't wrong.



Award Winning Film-Maker, Kevin P. Miller


Kevin P. Miller has created something quite beautiful with his latest offering, beautiful yet tragic.

From the opening reel we are shown a woman driving her car with her children in the back passenger seats - the scenery is stunning, the whole cinematic event being a reconstruction, one in which the stunning scenery pales into insignificance when we realise that this is no opening scene about the beautiful countryside or, indeed, about a mother taking her children out for a ride to educate them about their surroundings.

From here we are taken on a journey, the driver, Kevin P. Miller, is an award-winning film-maker and he takes us carefully through a minefield of information and disinformation courtesy of global medicine regulators and pharmaceutical companies. The narration is provided throughout by Oscar winner Tilda Swinton. We, through Miller's careful navigation, are driven through the stench of the lies and deceit, along the way we meet the victims of those lies and deceit. We stop, look and listen to their stories, all sounding familiar, all with one common denominator. Selective Serotonin Reuptake Inhibitors (SSRIs)

I've met a good number of the victims in this movie, I wish I hadn't. Our paths crossed because they had lost someone loved to SSRI induced suicide. I have spoken with many more of the subjects featured in Miller's two hour long documentary - hearing their stories again doesn't make it any easier for me to hold back the tears, the anger.

This is a movie that those of us who choose not to read about children, teens and adults killing themselves will, no doubt, turn a blind eye to. "I know it goes on but it's too upsetting to read", are just some of the comments I have heard about the articles that I write. Sorry folks but that just isn't good enough.

Every one of us has a duty to protect the most vulnerable, just ask the parents, partners, featured in Letters from Generation Rx why they advocate for better regulations of prescription medications. Everyone of them have, since the death of their loved ones, made remarkable strides in creating an awareness about the dangers of drugs such as Zoloft, Paxil, Prozac, Lexapro, to name but a few.

Letters from Generation Rx shows us the human side of devastation, it also shows us the inhumane side of the pharmaceutical industry and global medicine regulators. It's jaw-dropping when we are shown by Miller how many of the regulators have vested interests at heart opposed to what they were put into place for - protecting public health.

The relationship between global medicine regulators and the pharmaceutical industry is incestuous and one that is based purely on profit margins.

Miller's movie will have you reaching for the pause button so you can compose yourself after each story is driven home, it did me anyhow.

I doubt if the findings in Letters from Generation Rx will bother the likes of pharmaceutical CEO's or any of the limp-wristed medicine regulatory authorities around the world. They have become too corrupt, too greedy - their hearts have been blackened as they all sit in their ivory towers counting the dollars whilst dismissing the death and destruction that paved way for those dollars.

The movie is harrowing, to say the least. One story is bad enough to endure but to assemble a bunch of stories and to craft them into a two-hour documentary is something that Kevin P. Miller should be applauded for.

To add further incestuous ties to pharma and the medicine regulators the movie shows how Health Canada saw fit to go after one of the victims featured... all because he came up with a healthy nutritional supplementation program after his wife died and two of his ten children later struggled to cope with the loss of their mother. TrueHope, became the target of Health Canada who tried to stop them selling and distributing EMPowerplus to the thousands of participants in the Truehope program in Canada. You'll have to watch the movie to find out the outcome.

Kevin P. Miller has, through his craftsmanship, created something that we should all be queuing to buy and then, once we've all watched and condensed it, we should all be busting a gut to make sure that we don't take this pharmafia abuse lying down anymore.

Letters from Generation Rx is essential viewing and is set for general release in the coming weeks.

Here's a teaser...





Bob Fiddaman.



Official Website for Letters from Generation Rx (Currently being updated)

Letters from Generation Rx Official Facebook Page

Recent Interview with Kevin P. Miller



Sunday, June 29, 2014

Health Canada Secrets and Birth Defects




Canada's medicine watchdog, Health Canada, are in the news once again.

Last week it was reported that Health Canada were refusing to release its own internal report on the state of a GlaxoSmithKline plant in Quebec.

The American medicine regulator, the FDA, had previously found  bacterial contamination problems and had raised concerns about the purified water system at the plant. Health Canada carried out their own inspection but refused to release their findings [Health Canada Refusing to Release Glaxo's Dirty Secret]

Coming on the back of this is news is a report that Health Canada are also refusing to publish data on off-label drug side effects.

In a revealing editorial in The Star, David Bruser, Jesse McLean and data analyst Andrew Bailey report that Health Canada have been collecting the adverse reaction reports but refusing to publish them on the grounds that "It’s been collecting this information for six years but technical limitations with the database have prevented the public release."

"Indeed, the Star analyzed the information collected in the FDA database and found nearly 400 off-label cases from 2010 to 2013 that involve a range of side effects ranging from death to heart attacks, strokes, birth defects and organ failure.
"In Canada, the federal regulator collects the same information but removes the off-label details before publishing its side-effects database. Without this information, doctors and patients can’t ask the proper questions. It’s an offensive lack of transparency."

Dr. Joel Lexchin, one of Canada s leading authorities on drug safety, says, “There are significant public safety implications. This is a major problem for doctors and patients alike.”

Health Canada must publish this information and they must do it now. They have no right to keep this information from the public or health care professionals.

If evidence was needed as to why playing God has implications then one only has to read the latest news coming out of Canada regarding  a powerful anti-nausea drug being prescribed to women who are pregnant.

Zofran [ondansetron] has been approved by Health Canada to treat nausea and vomiting in chemotherapy and surgery patients but it has never been approved for use in pregnancy. However, like most drugs, Zofran is being prescribed in this population off-label.

The Star are reporting...

"At least 20 Canadian women treated with ondansetron for vomiting in pregnancy experienced serious suspected side-effects, including two infant deaths and multiple cases of newborns with heart defects and kidney malformations."

Back in 2013 I was contacted by Tomisha LeClair. She informed me that she fell pregnant in 1999 and like many women developed  nausea and vomiting and was prescribed Zofran.

At seven months gestation Tomisha was given an ultrasound and was told by doctors that her unborn daughter had a renal cyst; a fluid filled sac on one of her kidneys. The medical staff explained there are many children born with this complication and if necessary she could be treated with antibiotics upon birth.

She told me:

In the latter part of 2000 I wrote to the (FDA) the Food and Drug Administration to complete a Med-Watch form reporting my daughter’s “abnormalities”. I initiated a (FOIA) a Freedom of Information Act request to the Food and Drug Administration inquiring about the adverse reactions reported by other patients who had also been prescribed this drug, to compare them to Ahjanee’s abnormalities. My suspicions were that the “wonder drug” had caused Ahjanee’s abnormality’s. Several weeks later I received a 20 page alphabetical list of all the reported adverse reactions reported by other patients, compiled into percentiles.

She added...

The "adverse reaction" list from the FDA is 26 pages long and contains every "abnormality/anomaly" my daughter and many of the other children have.The Center for Drug Evaluation and Research (CDER) Report is alarming to say the least! If I had to be scientifically specific regarding what Zofran has caused within the children, I would say that Zofran prescription during pregnancy causes clusters of symptoms such as cranial abnormalities; my daughter has microcephaly  [Fig 1], and another child hascutis cutis aplasia (characterized by the absence of a portion of skin in a localized or widespread area at birth), and there is one more cranial/skull abnormality that I can't recall by name. One child has Ebstein anomaly (a congenital abnormality that is present from birth and affects flaps that make up the tricuspid heart valve) and another has Hirschsprung syndrome (missing nerve cells in the muscles of part or all of the baby's colon) and another has clubfoot.[Fig 2] - [See Are GSK Concerned About the Zofran Noise?]

Fig 1




Fig 2

Zofran is manufactured and marketed by GlaxoSmithKline.

Are we really surprised anymore?

In Canada the generic version of Zofran is sold by Mylan.

What exactly are Health Canada playing at here?

I thought you'd have to go a very long way to beat the ineptitude of the MHRA and FDA...Health Canada have beaten them in the Stupidity Stakes by a number of lengths!

For more information on Zofran birth defects visit MA'Z (Mother's Against Zofran Birth Defects), a Facebook community page created by Tomisha LeClair.

Bob Fiddaman






Friday, June 27, 2014

Health Canada Refusing to Release Glaxo's Dirty Secret




The Canadian medicine's regulator, Health Canada, are reportedly sitting on information pertaining to a recent FDA  inspection of a GlaxoSmithKline plant in QuĂ©bec, Canada.

In a letter to John Glavas Site Director, Quebec Operations GSK Biologicals, North America, the FDA raised concerns that related to bacterial contamination problems that were ongoing and may date back to 2011. Moreover, the FDA raised concerns about the purified water system at the plant.

The FDA also noted that since 2011 a total of 60 lots of vaccine from the plant have been rejected due to endotoxin levels that are over a pre-specified limit. Endotoxins are created by bacteria.

Glaxo manufactures roughly half of Canada’s seasonal flu vaccine order and has the country’s pandemic flu vaccine contract.

Health Canada carried out its own inspection of the plant but, according to The Toronto Star, are refusing to release its findings,

“Health Canada seems to be prioritizing what the companies claim is confidential business information over patient safety and that really isn't acceptable,” said Dr. Joel Lexchin, a health policy professor at York University and drug safety expert.
Health Canada refused to release the eight-page report in an emailed response. The agency said the inspection found no “critical risks” and the factory was given a “compliant” rating, but that it documented problems with contamination levels.

Great line, “Health Canada seems to be prioritizing what the companies claim is confidential business information"

So, if there is information that could be potentially damaging Glaxo scream, "Hey that's confidential business information".

Back in April  the FDA sent GlaxoSmithKline a warning letter listing a series of violations regarding one of their plants in Ireland. The plant, located at Currabinny, Carrigaline, Cork, Ireland, had been inspected by FDA officials back in October 2013 and it was found that batches of paroxetine [Known by it's brand names of Paxil, Seroxat and Aropax] had become contaminated with material from Glaxo's waste tank, which contained APIs [Active Pharmaceutical Ingredients], intermediates, and solvents.

A month later the Brazilian drug regulatory agency, ANVISA, sent Glaxo a warning letter stating that batches of Paxil may have been manufactured with the use of active ingredient in the presence of residues. As a result, the sale of Paxil was temporarily suspended.

Furthermore, in 2010 Glaxo were fined $750 million for failing to meet government standards for their drugs that were being manufactured at their Cidra plant in Puerto Rico. Violations that included...


  • Antidepressants containing different dosage strengths.
  • Heart medication containing different strengths.
  • A diabetes medication with a defect.
  • A children's ointment that was contaminated with a microorganism associated with bacteranemia, urinary tract infections, meningitis, wound infection, and peritonitis.
  • And a injectable drug used to treat nausea and vomiting in patients undergoing chemotherapy that was contaminated with micro-organisms.


Glaxo's mission statement is that they are "are committed to fighting disease by bringing innovative medicines and services to patients throughout the world".

Maybe they should start by reassuring consumers that there are no contaminated medicines leaving their plants!

Bob Fiddaman.


Monday, October 29, 2012

Health Canada Under Fire





Health Canada, the "independent" body of regulators who monitor the safety of drugs, have recently come under fire for failing to monitor the safety of drugs dished out to millions of Canadians every year.

I've highlighted Health Canada many times on this blog. They, just like other global medicine regulators, are about as useful as a waterproof teabag when it comes to safeguarding the public.

Yesterday The Star ran with the headline, 'Health Canada brushes off reports of serious side effects'. The article, written by David Bruser and Jesse McLean, heavily featured the story of Brennan McCartney, the 18 year old who killed himself just 4 days after being prescribed the powerful SSRi Lexapro [known as Cipralex in Canada] - Back story here.

Like many before her, Brennan's mother, Nancy, was shocked to find that the medication given to her son could actually induce suicide. This was learned after the event because the warnings about this adverse reaction are seen as a minor risk by Health Canada.


Saturday, July 21, 2012

Sara Carlin: She Would Have Been 24




Happy Birthday Sara Carlin.

24 today.

It's a cruel world when a life so precious is taken away. So many young lives lost to pharmaceutical companies and their lust for power, lies and greed.

Nessun Dorma, Sara.





Back stories HERE




Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

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Sunday, May 06, 2012

Sara Carlin - 5 years on

On May 6, 2007, Sara Carlin, a beautiful young woman from Ontario, tragically took her own life.

Her parents requested  an inquest to try to get to the bottom of why such a bright teenager would do such a thing.

A three week inquest culminated in the 5 person jury making 16 recommendations, one of which was a call for an independent regulator to monitor the safety of prescription drugs.

Not one of those recommendations have been implemented.

Sara Carlin was prescribed Paxil [known as Seroxat in the UK]. Paxil is not recommended for use in teenagers but doctor's still prescribe it anyway.

I've since met with Sara's family, they remain firm friends. They always will.

I created this video sometime ago, it's had over 11,000 views on youtube.

Today, just before 11am, my son and his wife gave birth to a bouncing 10 pound baby girl, Ruby Rose Fiddaman. I'm not going to draw any comparisons here.

Sara's voice is being heard

Nessun Dorma




Sara Carlin - coverage of the inquest HERE


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Friday, December 02, 2011

Health Canada Under Scrutiny



Health Canada, the Canadian medicine's regulator are to be examined and reported on with regard to prescription pharmaceuticals in Canada.

In a recent motion the Honourable Senator Ogilvie moved, seconded by the Honourable Senator Frum that the Senate Standing Committee on Social Affairs, Science and Technology be authorized to examine and report on prescription pharmaceuticals in Canada, including but not limited to:

(a) the process to approve prescription pharmaceuticals with a particular focus on clinical trials; 

(b) the post-approval monitoring of prescription pharmaceuticals;

(c) the off-label use of prescription pharmaceuticals; and

(d) the nature of unintended consequences in the use of prescription pharmaceuticals.

The committee are to submit its final report no later than December 31, 2013, whereupon it is hoped that by March 31, 2014 all findings will be made public.

I'm always weary of "investigations" into the way pharma does it's business through agents, end of the day Health Canada are merely batting for the same side as the pharmaceutical industry, I see no implementations of the 16 recommendations made at the Sara Carlin inquest almost a year and a half ago.

What's needed from this investigation is not the bog-standard recommendations, Health Canada will more than likely ignore them anyway. What is needed is for Health Canada to be more transparent, to open it's doors to the parents that have lost children to the very same drugs they were supposed to regulate.

I don't really care much for medicine regulators, it's apparent to me since I have been writing this blog that they are about as useful as chocolate teapot. Some will argue that we need them in place to protect us from harmful drugs, experience tells me that they do everything but that.

Regulators do not regulate, they merely pass the buck, they are pretty powerless and exist, it appears, to protect the purse strings of the pharmaceutical industry.

I hope the Senate Standing Committee on Social Affairs, Science and Technology can bring about some changes with implementations and not recommendations.

The motion can be viewed HERE





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Tuesday, November 01, 2011

Canadian Psychiatric Association Roll Out The Pregnancy and Depression Tool





Self reinforcing delusion:


1. a delusion is a false belief or opinion
2. and a self-reinforcing delusion is one that creates conditions that reinforce that false belief or opinion.



October 14, 2011 the Canadian Psychiatric Association [CPA] presented their 61st Annual Conference where they rolled out a soon-to-be published tool that, they claimed, may help ease the decision-making process for physicians and patients alike.

Sophie Grigoriadis, MD, PhD, from Sunnybrook Health Sciences Centre in Toronto, Ontario, Canada, presented preliminary data from a pilot test of an "urgently needed" tool to help clinicians assist pregnant patients who have moderate to severe depression make more informed treatment decisions.

Urgently needed?

Informed treatment decisions?


"Conflicting information about antidepressant medications in pregnancy has made it difficult for clinicians to figure out how to treat these women. What we're trying to do is help them cut through some of the confusion by summarizing the literature in a way that will make it easier apply to clinical practice," Dr. Grigoriadis told Medscape Medical News.

And what exactly was that help in summarizing literature?

Grigoriadis explains:

There were conflicting reports about antidepressant use in pregnant women. In addition, evidence was also published highlighting the risks associated with discontinuing antidepressant medication, and specifically highlighting the increased risk for depression relapse in women.

In the end we need to understand that patients are at risk no matter what decision they make. They are at risk because they are exposed to depression, and they are at risk because they may be exposed to antidepressant medication.


Fair enough, although I would err on the side of caution when treating a pregnant mother with antidepressant treatment, the risk of malformations in the fetus would far outweigh any benefit.

Grigoriadis continued with:

The investigators looked at more than 38,000 abstracts and 821 scientific papers. Of these, 187 articles were selected for inclusion in the tool and underwent a quality assessment by 2 independent reviewers, based on a number of predetermined criteria, and received a final quality rating: high, moderate, low, or very low.

Not surprisingly, she said, almost none of the papers garnered a high rating because very few were randomized controlled trials. Most, she added, were deemed to be of moderate or low quality.
In the face of FDA warnings, she added, one of the finer points about antidepressant medications that is often lost is that these drugs still confer minimal risk to the offspring.

"Depending on the number of studies, the results change slightly, but what we're seeing is that these drugs are not hugely teratogenic, and I think people may feel more comfortable regarding that when they understand that these are not huge effect sizes. You have to consider that 3% to 4% of women can have a baby with a congenital malformation just by chance alone, and people need to understand that," she said.

Not hugely teratogenic?

How huge does it have to be?

Sagar Parikh, MD, FRCPC, a psychiatrist and researcher with the University Health Network in Toronto, who was not involved in the development of the tool, said it will definitely help fill a clinical gap.

He concluded: "There are clearly some studies that show some harm from some medications, but studies like the Paxil study are difficult to interpret on a case-by-case basis. Even from a societal perspective, it is difficult to interpret. If I told you 100 children in Canada were hospitalized at birth because of their mothers were on Paxil, but that the drug prevented 300 women with depression from being hospitalized because they were on Paxil, how do we weigh that? And right now, no one knows how to approach this dilemma."


Ah, no one knows.


Pretty much like a game of Russian roulette then, huh?

The CPA could always ask the pharmaceutical companies that manufacture these drugs if they are teratogenic, or maybe even approach Health Canada and ask them.

It's simple really but would, of course, throw a spanner in the works of this latest tool rolled out by psychiatry.

I applaud the Ying and Yang arguments but the debate about whether or not antidepressant medication can cause birth defects is a no-brainer - See Kilker Vs GlaxoSmithKline

Or, if you can stomach it, watch this short video:




The study was supported by the Canadian Institutes of Health Research. Dr. Grigoriadis reports she is on the advisory board of Servier Canada. Dr. Parikh reports he has financial/research relationships with Mensante, AstraZeneca Canada Inc, Bristol-Myers Squibb Inc, CANMAT, Eli Lilly Canada Inc, Lundbeck Canada Inc, and Pfizer Canada Inc.

Say's it all really.



Fid

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Tuesday, October 18, 2011

Baby Matthew's Voice Is Finally Heard



I've highlighted the story of Matthew Schultz on my blog many times in the past. Matthew was just two hours old when he died in the arms of his parents Christiane and Amery. Christiane had been taking the powerful antidepressant Effexor during her pregnancy and shortly after giving birth to Matthew it became apparent that he had breathing problems. Two hours later he was pronounced dead, leaving both Christiane and Amery in complete shock, leaving them with many questions that hospital staff could not answer.

Upon learning of the dangers of taking SSRi/SNRi medication during pregnancy, the Schultz family started to ask questions, once again nobody could give them any definitive answer.


Matthew died Feb. 21, 2009, some two and a half years later a glimmer of progress has been made toward creating an awareness about the dangers of antidepressant use during pregnancy.

Yesterday, Kamloops This Week,[KTS] a local newspaper, broke the news that the Royal Inland Hospital, where Matthew was born, had deemed, via their perinatal review committee, that there was “value” in exploring the issues raised by the Schultz family. "The review", writes KTS, "has been forwarded to RIH’s quality committee, another group that can continue to study the issue."

Christiane and Amery have never given up in their battle, in doing so they have created an awareness for pregnant mothers and those wanting to fall pregnant. In their pain they may just have allowed another couple to experience the joy of life, an unselfish act that should be commended.

I salute you both.

Full story HERE

More about Matthew HERE

The following video was made with the permission of the Schultz family.

RIP Little Man.



Fid

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Saturday, October 01, 2011

Judge Agrees Prozac Made Teen a Killer.



It's always difficult writing about murder, particularly as it may upset the family of the victim. Many families who seek justice through the courts would no doubt feel that there is simply no excuse for anyone who takes the life of another - self-defence may be a decent argument, pleading insanity may also be a first line of defence... but what about murder induced by prescription medication?

Well, a Manitoba judge has ruled that a Winnipeg teen was driven to commit an unprovoked murder because of the adverse affects of taking Prozac. The Judge, Robert Heinrich, came to this conclusion after listening to the testimony of Psychiatrist Peter Breggin MD.

PRLOG reports:


This was the first criminal case in North America where a judge has specifically found that an antidepressant was the cause of a murder.

The case involved a teenage high school student with no prior history of violence who, while chatting in his home with two friends, abruptly stabbed one of them to death with a single wound to the chest. The boy had been taking Prozac for three months, during which time his behavior deteriorated. He became impulsive and unpredictable, and suicidal. He also began to talk at times as if fantasizing about violence. He seemed to become a different person to his distraught parents. Dr. Breggin testified that his primary care physician and his parents alerted the prescribing psychiatric clinic to the boy’s deteriorating condition, but the clinic continued the Prozac and then doubled it. Seventeen days after the increase in dosage, the teen committed the violence.


The news first broke in the Winnipeg Press on 17 September and can be viewed HERE

As a parent I would find it difficult to accept that a prescription drug had caused someone to murder my child but knowing what I know about this class of drugs [SSRi's] and having experienced homicidal thoughts myself whilst taking and withdrawing from Seroxat [Paxil] I am in no doubt that SSRi medication can cause feelings such as homicidal thoughts. It's well documented that antidepressants can cause suicidal thoughts yet kind of sniffed at when homicide is mentioned as an adverse side effect.

A life is a life, whether it be your own or someone else.

Pharmaceutical companies and medicine regulators all over the world have been told of the link time and time again. They have chose to ignore, blaming the "illness" instead of the medication.

They will no doubt refute the findings of the Judge in this particular case, the same as they do with other claims of antidepressant related homicidal crimes.

I fully expect the bog-standard reply from an Eli Lilly spokesperson, it will no doubt be along the lines of, "Prozac has benefited millions of people worldwide."

They fail to tell you about those it has not benefited or those that have taken their own lives or the life of another whilst on it.

Recommended reading: - The Power to Harm: Mind, Medicine, and Murder on Trial

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Monday, July 18, 2011

Health Canada Continue to Ignore the Voices of the Dead

Sara Carlin


One of Canada's biggest selling newspapers, The Globe and Mail, last week featured an update on the recommendations made last year at the inquest of Oakville, ON, teen Sara Carlin.

It was made apparent for all to see that Health Canada, the nation's drug regulator, intend to do nothing to warn doctors and patients about the dangers of children and adolescents being prescribed SSRi type drugs.

Personally, this comes as no surprise to me, Health Canada are basically the same as other drug regulators around the world in as much that they are a limpless machine churning out the same old bullshit when a drug they are supposed to regulate comes under fire.

Back in June last year I covered every day of the Sara Carlin inquest, I labelled it the 'Sara Carlin Vs GSK and friends inquest' because it was pretty obvious from the start that the Coroner wished to completely exonerate Glaxo's Paxil [known as Seroxat in the UK] from causing 18 years old Sara Carlin to take an electric piece of wiring, wrap it around her neck and hang herself in the basement of her family home.

Halfway through day one of that inquest saw Coroner's counsel, Michael Blain, appear in front of TV camera's outside the inquest. Here's what he had to say:



Nice of Blain to offer his opinion halfway through the first day of the inquest!

The jury in the inquest, who actually waited until the inquest was complete, made 16 recommendations, one of which was a call for an independent drugs regulator, it was apparent that they too were not confident in Health Canada's role of monitoring drugs.

Last week the Globe and Mail issued a statement from Health Canada regarding this one particular recommendation, a statement that merely highlights their lack of care and buck passing because they don't want to take accountability for their own incompetence in monitoring drugs such as Paxil.

Health Canada, writes the Globe and Mail, responded by saying it already implemented that recommendation, citing the 2002 creation of the Marketed Health Products Directorate within the department that focuses on surveillance of drugs. It also noted the government set up the Drug Safety and Effectiveness Network, which operates as part of the Canadian Institutes of Health Research.

Health Canada's full response is posted on their website, a labyrinth to navigate around.

Here's what Health Canada failed to add.

Health Canada, in typical buck-passing style, responded by stating that they had, in 2002, already implemented the creation of a board that would operate independently from Health Canada. What they didn't add was that Pfizer Canada VP, Dr. Bernard Prigent was appointed to the governing board of Canadian Institute for Health Research (CIHR) which oversees the Drug Safety Effectiveness Network (DSEN) - the very same body that Health Canada tout as an independent Drug safety agency!

This conflict of interest raised eyebrows with the Canadian House of Commons Committee back in 2009.

Prof. Jocelyn Downie (Canada Research Chair in Health Law and Policy, Professor of Law and Medicine, Dalhousie University addressed the committee and made three points regarding Pfizer's Dr. Bernard Prigent's appointment:

First, Dr. Prigent's ability to bring his expertise in innovation and commercialization to the GC table is fatally limited by the fact that he is currently a Vice-President at Pfizer. A qualified candidate must not only have certain knowledge and skills but must also be able to use his knowledge and skills. This is a significant problem for Dr. Prigent.

Second, commercialization is not CIHR's objective. Rather, it is but one means for realizing CIHR's objective, which is, in fact, “the creation of new knowledge and its translation into improved health for Canadians, more effective health services and products and a strengthened Canadian health care system”.

Third, not only are innovation and commercialization only a means to CIHR's objective, but they are not the only nor the most important of CIHR's statutorily mandated means of achieving its objective. The CIHR Act requires CIHR to meet its objective by, among other things, “promoting, assisting and undertaking research that meets the highest international scientific standards of excellence and ethics”. By contrast, “encouraging innovation, facilitating the commercialization of health research” is but one of 12 means available to CIHR.

It's amazing isn't it? Time and time again these lilly-livered drug regulators shirk their responsibility and think everything will be just peachy clean if another board is created to help regulate drugs...providing that board has someone at the helm who has an Oh so obvious conflict of interest.

Health Canada's response to this particular recommendation smacks of a 'couldn't give a shit' attitude. It highlights their failure to protect children and adolescents from harmful drugs and shows their lack of care when it comes to giving impartial voices to 'independent bodies' that actually wish to protect the patients rather than the pharmaceutical industry.

I'd love to meet with Health Canada, it would be like Groundhog Day for me as I have already met with their British counterparts, the MHRA. I wonder if Health Canada would nod their heads and show empathy just as the MHRA did to me. I wonder if Health Canada would pretty much ignore the problems patients are facing once I left the meeting table...just like the MHRA did with me.

To be honest, I've got far better things to do than to meet with limp-wristed cowards who are severely lacking in the gonad department. I'd rather bang my head against a brick wall than meet with medicine regulators whose sole purpose is to protect themselves from their own failures at the expense of human life.

I'll be in Canada later this year, I'll pay my respects to Sara Carlin in a private moment by her resting place. I'll tell her I tried my hardest to give her a voice and I'll tell her that, in her death, she has created an awareness for many parents across Canada, an awareness that the limpless folk at Health Canada should have been on top of years ago.

The Globe and Mail article can be read HERE - The comment section sees the pharmacuetical shills at work once again. Those who have left appalling comments and sided with GlaxoSmithKline and their shills should be utterly ashamed of themselves. [1]

Related:

Sara Carlin - Death by Paxil Inquest [PDF]

[1] The Inquest of Sara Carlin and the Moderation of Yahoo Groups

Sara's Voice [Over 6,000 views]



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Wednesday, June 15, 2011

It's Official: Antipsychotic Drugs Labelling Update



Health Canada has released a warning to Healthcare professionals and consumers regardng Antipsychotic drugs and the risk of abnormal muscle movements and withdrawal symptoms in newborns exposed during pregnancy.

Now they tell us!



Antipsychotic drugs: Labelling update regarding the risk of abnormal muscle movements and withdrawal symptoms in newborns exposed during pregnancy.

Health Canada is informing healthcare professionals and consumers that the prescribing information for the entire class of antipsychotic drugs is being updated. The updated labelling will contain safety information on the potential risk of abnormal muscle movements and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of their pregnancy.


So, if a child in its mother's womb can suffer withdrawal by proxy, just imagine what suffering the children throughout classrooms of the UK, Canada, America, Australia etc will have to endure.

Here's a list of some antipsychotic drugs that are causing severe withdrawal problems with children today. Will the regulators be doing anything to help the millions of children worldwide that are hooked on these?


aripiprazole - Abilify

clozapine - Clozaril

olanzapine - Zyprexa

quetiapine - Seroquel

risperidone - Risperdal

ziprasidone - Geodon

Do you wish to continue labelling children with psychiatric disorders just so drugs [such as the above] can be ingested by children?

Wake up world. It's fraud, pure and simple.



Fid





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Tuesday, March 22, 2011

Two Hours With Matthew - The Story of "Effexor Baby", Matthew Schultz.







Over the years I have been writing this blog I have come across some truly heart rending stories with regard to the loss of life. I've spoken at length with parents of those who have fallen foul to the greed of pharmaceutical companies, strived to highlight the truth that the mainstream media are too afraid to publish for fear of lawsuits hanging over their heads from manufacturers of antidepressants who wish to keep the truth within the confines of their vaults. Up to now, I've never really dived into the death of newborns, those unfortunate souls who died within months, weeks, days, and in the case of Matthew Schultz, hours.


Matthew was born on February 21, 2009. His parents, Amery and Christiane, spent just two hours with him before he passed away. He weighed just 7 pounds 3 ounces. He went into cardiac arrest shortly after he was born.


Matthew died from Effexor exposure, although at the time his parents didn't know this. Why would they? Effexor carried no warning. Neither Amery or Christiane were warned about the potential dangers of taking Effexor whilst pregnant, they were told many, many times that Effexor was safe.


Matthew's mother had been taking Effexor during her pregnancy, she was prescribed it by her doctor, who had diagnosed that she was suffering with "severe chronic depression", as a matter of fact, Christiane had been taking Effexor for 8 years prior to giving birth to Matthew.


"Christiane was never really truly depressed", recalls husband Amery, "Effexor never really changed her moods at all. However, once Christiane was on Effexor she found it almost impossible to get off." Amery added, ".. they turned her into an emotional zombie. Although she still had depressive symptoms, she never truly had happy moments."


During her 8 years on Effexor, Christiane had given birth to three other children, two of them were born with heart murmers whilst the third was born extremely under-weight at full term and also had a lung disorder. At no point did doctors associate Effexor being the causation of the three children being born with defects.


During her pregnancy with Matthew, Christiane asked the OBGYN, the physician who specializes in medical and surgical care to women with expertise in pregnancy, childbirth, if it was safe to take Effexor whilst pregnant. The reply, recalls Amery, was, "Women take this stuff all the time, we don't see any problem with it."


Christiane recounts on an early blog post of hers that both her and husband, Amery, had done a lot of research since their son had died. She writes:


Since Matthew died, we have done a lot of research. Turns out that my antidepressants have serious side effects. Not only to me, but my children through me. That would explain why out of 5 pregnancies, I have had something wrong with all of them. And why each subsequent pregnancies were more and more difficult.


Furthermore, both Christiane and Amery supplied their doctor with large amounts of evidence regarding Effexor and infant death they had obtained off the internet. Their doctor was astonished.


Too little, too late for Amery and Christiane.


The Canadian drug regulator, Health Canada, have, in the past, issued warnings to doctors regarding taking SSRi/SNRi medication whilst pregnant. This, however, is just not implemented, in fact, doctor's don't even have to read any warnings they get from Health Canada.


On June 28, 2004 some 5 years before Matthew was born, the FDA and Wyeth [Effexor's then manufacturer] issued a new MedWatch drug Alert to healthcare professionals: [1]


"Neonates exposed to Effexor, other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors), late in the third trimester of pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding."


This information was sent out to the medical profession in America. Two years later, in 2006, Health Canada issued a warning to all pregnant women considering becoming pregnant that SSRI drugs similar to Effexor may pose life-threatening risks to their babies. Nursing mothers were also warned that SSRIs could be secreted in milk and could have an effect on nursing infants. [2]


So, why, if this information was out there, did Christiane continue taking Effexor?


It's simple really, the public are rarely told by the medical profession about such warnings because the doctor's, nurses, OBGYN's, psychiatrists, rarely read the warnings. Like the UK, there is no system in place to make the medical profession read the warnings. The regulator has a clear conscience because they can profess that they did everything to warn about the dangers.


We know that's bullshit, right?


If the CEO of Health Canada saw his daughter climbing into a rubber dinghy and he knew that rubber dinghy had two holes in it, do you honestly think he would send her a letter of warning?


Of course not, it's absurd.


With millions of dollars spent on the promotion of these drugs, is it too much to ask Health Canada, or any other regulator for that matter, that when a warning as severe as death occurs, they shout it from the rooftops rather than send a letter that may never be opened by the recipient?


It's common sense really...then again, if Health Canada are anything like the British drug regulator, the MHRA, common sense won't be in their dictionary.


Amery and Christiane have been at loggerheads with their coroner regarding Matthew's death. In February, 2011, Amery received the final coroner's report. It was delivered to him on the 21st February, Matthew's 2nd birthday and 2nd anniversary of his death.


Fantastic timing huh?


What is utterly perverse about the coroner's report is that Coroner Robert Saunders, Province of British Columbia, stated that there was no anatomical or toxicological cause of death. Yet under the heading, "Other Significant Conditions Contributing to Death", Exposure to venlafaxine in utero is listed? Furthermore, the coroner adds that this is "Natural" [See pic below]


Click to enlarge




In essence, Saunders is stating that it is natural for anyone to die after being exposed to Effexor in utero.


Amery, obviously, was incensed, who wouldn't be? This prompted him to write a blog entitled, "How far could your head be up your ass?" He opens with the paragraph;


This past week I recieved what is supposed to be the final report from the Coroner on Matthew’s brief life and death. As I allude to in the title of this posting, the presiding coroners have their heads firmly implanted in their collective asses. I have taken the liberty of uploading the three pages of the report here. The irony of this report being issued on Matthew’s second birthday was not lost on us.


One has to question the insensitivity of the coroner here. He can't claim to not know the date of Matthew's death as it is plastered all over the report, so why send it out to parents on what would have been such a sombre date for them?


The Coroners Service of British Columbia is responsible for the investigation of all unnatural, sudden and unexpected, unexplained or unattended deaths. It makes recommendations to improve public safety and prevent death in similar circumstances.[3]


I've said in previous articles I have wrote that coroner's deal with death on a daily basis, seeing a dead body is like eating a bowl of cornflakes, it's such a regular occurrence but for crying out loud, show some tact when sending out reports to grieving parents!


Amery and I have corresponded over the years. I feel for him and I also greatly admire him. Yet again, life has been snatched away from loving parents, a life that was not given a chance because a greedy pharmaceutical company and an inept medicines regulator failed in their duty to give Matthew Schultz a chance of life. It's a despicable act and one that should never be forgotten.


Fid


[1] http://www.ahrp.org/infomail/04/06/29.php
[2] http://www.lawyersandsettlements.com/case/effexor-heart-birth-defects.html
[3] http://www.pssg.gov.bc.ca/coroners/


Further reading


http://twohours.wordpress.com/


Matthew's Facebook page


**The following video contains images that some viewers may find deeply upsetting. It is with the wishes of both parents that these pictures be shown to highlight the dangers of taking SSRi/SNRi medication whilst pregnant.




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