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Tuesday, June 22, 2010

Sara Carlin Inquest - The Eli Lilly 'Links' & Today's Recommendations.


Image: Sara Carlin


The Oakville Beaver has now posted the list of recommendations.

Lawyer Gary Will, on behalf of the Carlin family, submitted 26 recommendations to the jury examining the suicide of Sara.

As you will note, the Carlin's have put forward these recommendations for the future safety of other children and adolescents in Canada.

It's taken a gruelling two weeks for them to get to this stage.

Another inquest into the death of a child/adolescent taking Paxil or any other SSRi/SNRi should never have to happen again.

If these recommendations are carried then the citizens of Canada, indeed the world, owe the Carlin's a huge thanks. They have sacrificed pain to get to this point and it has been a journey faced with lawyers who have tried to paint Sara Carlin in a bad light. This also, should never be forgotten.

Neil, Rhonda and Meghan Carlin have been to Hell for every single parent in Canada. They have sat and listened to 'expert' witnesses claim that it was Sara's drinking and substance abuse that caused her to kill herself and that it had nothing to do with Paxil. They have relived the moments when they found their beautiful daughter hanging from a wire in their basement on May 6th 2007. They have faced TV camera's upon entering and leaving the Coroner's Court. They have read one sided articles with eye-catching headlines from the Canadian mainstream media who print the 'meaty' bits just to sell their newspaper.

The majority of Newspapers reporting on this inquest have failed the Carlin's, they, like GlaxoSmithKline, have put profit before morality.

The Carlin's have also had to endure Michael Blain, Coroner's Counsel, appear in front of a TV camera and state during a court recess on Day One of the inquest.

His appearance in front of TV camera's outside the Coroner's Court on day one served no purpose other than to defend Paxil.

The video, now hosted on YouTube sees Blain categorically state:

"The courts acknowledge that this medication can increase thoughts of suicide in particular patients but they don't think that the medication played a role in Sara Carlin's death."

Quite an astonishing statement considering this was day one of Sara's inquest.

Before viewing the recommendations put forward today by the Carlin family, I'd like to show you what the papers didn't. They have their reasons I guess but by failing to show the public of Canada exactly what the Carlin's have been up against at this inquest is unforgivable.


First, I'm going to throw a question out:

Just what makes a good [reliable] expert witness?

One would assume someone who is impartial and has nothing to gain by defending this or that.

Certain questions have to be raised regarding the witnesses called by the Coroner's Counsel and GlaxoSmithKline in the Inquest of Sara Carlin. In fact, one of the biggest failings thus far in this inquest was the Coroner's Counsel, Michael Blain, desire to appear in front of TV camera's during a short recess on day one of the inquest.

For me, Michael Blain had a duty to remain impartial in this case.

Other witnesses called to give testimony also, it would appear, have more of a reason not to chastise SSRi type drugs.

See if you can join the dots here.

Dr. Lynne Benjamin -> Dr. Paul Links -> Andrew Merrick

I'll help.

The odd one out, at first glance, would appear to be Andrew Merrick as he had nothing to do with this inquest...at first glance.

However, something of significance, that neither the Toronto Star or Oakville Beaver showed with their various reports of this inquest, becomes apparent when you join the dots.

It's difficult at first as Dr Lynne Benjamin, the doctor who increased Sara's Paxil from 20mg to 30mg, prefers not to use her married name.

Her married name being Merrick - her husband being Andrew Merrick, Director of Corporate Affairs for Eli Lilly Canada.

So where does Dr. Paul Links fit in?

Dr. Paul Links is a professor of psychiatry at the University of Toronto, deputy chief of psychiatry at St. Michael's Hospital, and past president of the Canadian Association for Suicide Prevention.

He was called as an expert, one would assume, because he works daily with suicidal patients and holds an academic chair dedicated to the study of suicide, the Arthur Sommer Rotenberg Chair in Suicide Studies at the University of Toronto.

GlaxoSmithKline invested more than $178 million in Canadian research and development (R&D) in 2007 alone, ranking it among the top 15 contributors to R&D in Canada, across all industries.

Here's some instances where the University of Toronto pops up on the Canadian GlaxoSmithKline page.

$1 million endowed Chair in Pharmaceutics at the University of Toronto.

GlaxoSmithKline is contributing $3.75 million to the Structural Genomics Consortium (SGC), a three-year project led by Dr. Aled Edwards at the University of Toronto. The SGC will contribute to the discovery of new products for unmet medical needs.

Links has also, in the past took an “unrestricted educational grant” from Eli Lilly Canada, the very same Eli Lilly Canada where Andrew Merrick is Director of Corporate Affairs, the same Andrew Merrick who is married to Dr. Lynne Benjamin.

Quite why the media have failed to report this is quite bewildering.

Benjamin's deposition is quite staggering, a snippet of which is included in this post.

There is an issue, again not reported by the mainstream media, whereby Benjamin, after talking with Sara Carlin, prescribed her 30mg of Paxil.

In Benjamin's two notes there seemed to be a discrepancy. One said that she had increased Sara's Paxil dosage from 20 to 30mg, the other mentions an increase to 25mg using Paxil CR.

Paxil CR is a controlled release version.

Under cross examination from the Carlin's lawyer, Gary Will, Benjamin was asked about this discrepancy.



GARY WILL: You made a decision to increase her [Sara's] Paxil dosage from 20 to 30

DR. LYNNE BENJAMIN: Yes, I did.

GARY WILL: Now, er, did you know what the actual prescription was that you wrote... was it for 30 milligrams?

DR. LYNNE BENJAMIN: I wrote that I increased her Paxil to 30 milligrams, yes.

GARY WILL: Who actually wrote her prescription?

DR. LYNNE BENJAMIN: I wrote the prescription at the end of her visit.

GARY WILL: And was that prescription for 30 milligrams?

DR. LYNNE BENJAMIN: Yes

GARY WILL: And you note in the other note that the Paxil dosage was CR 25.

DR. LYNNE BENJAMIN: Right.

GARY WILL: Did you write a prescription for Paxil CR 25?

DR. LYNNE BENJAMIN: I don't think I did, I think I wrote the initial prescription for 30.

GARY WILL: Right. You didn't write her two prescriptions?

DR. LYNNE BENJAMIN: I had no reason to do that.

GARY WILL: But you did in this case?

DR. LYNNE BENJAMIN: No.

GARY WILL: Do you have a memory of what prescription you wrote her?

DR. LYNNE BENJAMIN: My memory is of 30...but I'm also going by what I wrote to jog my memory.

GARY WILL: You'd agree it's a little confusing?

DR. LYNNE BENJAMIN: Yes it is.

GARY WILL: Could have been 25 or it could have been 30?

DR. LYNNE BENJAMIN: Well the 25 CR is the equivalent to 30 and I think that's why I made the error.

GARY WILL: But, er, Paxil CR 25 is a Paxil medication but it's a slow release medication.

DR. LYNNE BENJAMIN: It's supposed to be more effective... or in some cases.

GARY WILL: More effective for what?

DR. LYNNE BENJAMIN: Uh, the company I guess recommended to us that it would be...get better blood levels for treatment of anxiety and depression.

GARY WILL: Is that what GSK told you?

DR. LYNNE BENJAMIN: I have been aware of that through CME, some how. [The Canadian Journal of CME]


I can't quite grasp Benjamin's selective memory here. There is much, much more that I will post at a later date.


The whole of Canada owes the Carlin's an immense show of gratitude. Health Canada should be totally embarrassed by all of this. They, like the MHRA and FDA have heard countless stories regarding suicide and Paxil. They have not done enough and it now takes the parents suffering the loss of their dead daughter to put forward recommendations that these limp-wristed agencies should have, could have done years ago. Had they have then Sara Carlin would probably still be alive today as would UK teenager Sharise Gatchell, another teenager who hanged herself whilst on Paxil.

Neil, Rhonda, Meghan, I salute you all. Your bravery throughout this ordeal has been inspirational.

Finally, I want to pay tribute to Sara Carlin. A beautiful looking teenager whose life is now but a memory for those that knew her.

Sara, you too have given me the drive to do what I do. You and the countless others who have lost their lives to these family of drugs give me great strength to continue to do what I do.

In the name of justice and common sense - you, Sara, will forever be etched in my memory as the one person I wish I could have met, if only to say, everything will be alright. If only to show you what Paxil can do to kids of your age.

Sara Carlin, 18 years on this earth, your death a constant reminder of the failure of the regulatory system, the medical profession and a pharmaceutical company who prefer profit before human life.

You shall go down in history Sara. The jury owe you that.

Bob Fiddaman.


Here are the recommendations put forward by the Carlin family earlier today.

This, I recommend, is Sara's Law:

1. We recommend that all doctors be required to provide informed consent to all patients being prescribed antidepressant drugs, including Paxil and all other SSRI and SNRIs, using the model currently considered good clinical practice in British Columbia for anyone under 18 years of age. (Ex. 20)

This includes an SSRI/SNRI monitoring form and information sheet being provided to patients (and their families) and a requirement for the doctor to discuss the true risk/benefit analysis with the patients, and document that discussion.

This discussion should also include a discussion of all reasonable alternative treatments and any material risks and benefits of such alternative treatments.

This discussion should include all material risks and the risk of suicide and record exactly how the patient will be monitored for suicide.

2. Patients should have a published Bill of Rights which incorporates as a principle: “The Right to Informed Consent”. This means good, complete and balanced information based on scientific evidence of a drug’s efficacy and safety.

3. That in all cases where a drug has not been approved for use in children where there are potential life threatening adverse consequences that the doctor must discuss the drug with the parents or legal guardians of the patient unless there is a written direction from the patient that which prohibits this communication.

4. That the College of Physicians and Surgeons of Ontario provide practice guidelines and training to family physicians on administering and monitoring the use of antidepressants (SSRIs) in adolescents.

5. The information provided to patients should be standardized and handed out with the drugs and be in plain language.

6. The information provided to patients should include:
(i) the benefits of the drug, not just “it might help”. That includes the real effects of the drug, how many people it helped and under what conditions, and how much better it was than a placebo;
(ii) the risks of taking the drug: not just the common side effects, but the things that might happen and the rare serious side effects. A layperson should be able to understand the true level of risk in their personal situation and make an informed choice;
(iii) the alternative treatments to the drug: including what would happen if you do nothing, any lower cost treatment that might work as well, or a lifestyle change that might help the condition.

7. Drug labels and patient safety information leaflets should make patients prescribed a drug aware of any safety issues related to that drug in other countries, including but not limited to any related deaths or serious injuries due to drug reactions.

8. Consumer Package Inserts should state up-front in plain language, any warnings patients may need to decide whether or not this drug is safe for them, or if they wish to go back to their doctor for more advice.

9. Monographs should not list only officially reported adverse reactions, which are a tiny fraction of real reactions, but the fact that reported adverse reactions represent only a tiny fraction of actual events.

10. Any and all clinical studies that are sponsored by drug companies or their affiliates should be registered when begun and the results reported to a Canadian drug safety agency by law.

11. The Dear Healthcare Professional letters issued by drug manufacturers and/or Health Canada when issuing a drug warning should include other suggested alternative treatments.

12. Patients should know when a drug has never been tested on a large group of people or never tested on children.

13. Drug companies should provide software and updates to doctors which list all contraindications for their products in plain language on the Internet available by download to PCs and hand-held computers on demand.

14. Drug companies should be required to report all serious adverse events associated with their drugs from all foreign jurisdictions within 30 days of the adverse event.

15. Any company that blocks the dissemination of significant safety / efficacy information on drugs sold in Canada, or withholds such information, should face significant penalties commensurate with their financial position.

16. That drug manufacturers be required to report the results of all clinical trials to Health Canada.

17. That drug manufacturers be prohibited from requiring researchers to sign non-disclosure contracts.

18. Patients should also be able to get this approved information from an independent drug safety agency by calling a free 1-800 # as well as information regarding their right to be properly informed.

19. There should be an arms length body independent from Health Canada called the Drug Safety Board which is solely dedicated to drug safety and which reports to Parliament and is funded by the Federal Government, which receives no money from drug companies. Amongst its mandated responsibilities should be investigating adverse reactions and issuing warnings to the public and health care professionals and hospitals.

20. Health Canada, or the new Drug Safety Board, should study the extent to which serious adverse events remain unreported. This data should then be used when sending out information to physicians or the public concerning reported adverse events by cautioning the reader that actual adverse reported events likely only represent 10% of the actual adverse events.

21. Health Care Professionals should be required by law to report any suspected adverse drug reaction to Health Canada, or the new Drug Safety Board, within 48 hours. This would act as an early warning system with new drugs, and help identify rare but serious reactions and dangerous contraindications.

22. There should be a presumption that all health care records concerning a patient are to be forwarded to the patient’s family physician unless there is a written direction from the patient that particular records are not to be forwarded to the family physician.

23. Ontario should adopt a Provincial Suicide Prevention strategy.

24. Canada should adopt a National Suicide Prevention strategy.

25. The Province should develop a strategy to create a single prescription drug database to facilitate research into drug safety issues.

26. The Provincial Ministry of Education should incorporate into its high school curriculum courses directed towards dealing with alcohol and drug abuse issues.

BACK STORIES ABOUT THIS INQUEST

Sara Carlin Inquest – Latest

Sara Carlin Inquest – Failure of Oakville Medical Profession

Sara Carlin – ‘Death by Paxil’ Inquest – The ‘Expert’

Sara Carlin Inquest – Coroner’s Witness In U-Turn… And That Man Shaffer!

SARA CARLIN Ontario, Canada

Coroner’s Inquest – Glaxo & Friends Vs The Carlin Family

Sara Carlin Inquest – Local MP Slams GlaxoSmithKline

SARA CARLIN PAXIL INQUEST VIDEO FOOTAGE

SARA CARLIN PAXIL INQUEST GLOBAL TV NEWS

SARA CARLIN INQUEST - What The Jury Should Know

Sara Carlin Inquest - "Paxil likely played important role in teen's suicide"


On May 6, 2007, Sara Carlin, a beautiful 18-year-old girl with everything to live for, grabbed a piece of electrical wiring, fashioned a crude noose and hanged herself in the basement of her parents house while under the influence of the antidepressant drug Paxil (Seroxat in the UK). Paxil/Seroxat is an antidepressant documented by international drug regulatory agencies as causing worsening depression and suicide particularly in children and young adults.

Please help inform others of the risks of these drugs. Forward this video to everyone you know.

RIP Sara Alison Carlin

Nessun Dorma



Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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