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Thursday, March 12, 2009

Email from Health Canada [Canada's MHRA]

A while ago I wrote to Health Canada [Canada's equivalent of the MHRA/FDA] regarding Conflict of Interest Declarations for members of the 2004 Scientific Advisory Panel on Selective Serotonin Reuptake Inhibitors (SSRI) and Serotonin/Norepinephrine Reuptake Inhibitors (SNRI).

The members in question were:

Dr. Yvon Lapierre, Dr. Clive Chamberlain, Dr. Jane Garland, Dr.Paul Links, Dr. Aidan Stokes, Dr. Nicole Thibodeau Health Canada (HC)

Working Group Members:
M. Davis (SAP Secretariat Officer, PB), L. Kelly (BCANS), S. Mithani(BCANS), E. Ormsby (SAP Scientific Advisor, PB), C. Petersen (BCANS), Karen Reynolds (BCANS)

Today they mailed me back:

Dear Mr. Fiddaman,

I am contacting you to respond to your request through for information regarding Conflict of Interest Declarations for members of the 2004 Scientific Advisory Panel on Selective Serotonin Reuptake Inhibitors (SSRI) and Serotonin/Norepinephrine Reuptake Inhibitors (SNRI). I apologize for the delay in replying but the records for this panel were archived and had to be retrieved.

Your request came to me because the Office of Science (OoS) was responsible for the running of this panel. I will give you a brief outline of how the Conflict of Interest (COI) declarations were handled in 2004, with some additional information that will hopefully answer some of your questions.

When Health Canada identifies a post-market drug issue which requires external expert advice (especially one such as the use of SSRI's in the paediatric population) , a request is made to OoS to put together a panel with individuals who have required expertise in the area of concern. We find these members through various means such as nomination calls to targeted relevant medical/health organizations and associations, universities and hospitals, patient interest groups, etc. We can also post the call letter to our web site.

Nominations are sent to us, and we contact the nominees to ask them to fill out a Conflict of Interest Declaration form as part of their membership selection process. (Today, we refer to this form as a Statement of Affiliations and Interest Declaration. A full detailed explanation of this can be found in the following two documents, URL listed below:)

Health Products and Food Branch Guidance on Advisory Bodies

Health Products and Food Branch Review of Regulated Products: Policy on
Public Input

As you can well imagine, it is difficult to find an expert that has the experience and expertise required to give solid, leading edge advice without having had some degree of interaction with related industries. Therefore, once Health Canada receives the completed COI declarations from the nominees, an internal COI review committee assesses the responses and decides if the nominee can participate on the panel. Advice is sometimes sought from the Chair of the Panel as well. As outlined in the Guidance on Advisory Bodies document listed above, in keeping with Health Canada's commitment to openness and transparency, we presently advise the nominees that a summary of their declaration will be drafted for their approval, and that this summary will then be posted on our web site. However, in 2004 when this panel was held, this was not our policy and the nominees were advised that this information would remain confidential.

Since our processes have changed on this topic over the years since this panel was held, and in an attempt to provide you with a sense of how we assessed the COI for this particular panel, I have attached a blank version of the exact COI form that was used for the SSRI Panel for your convenience. You will see on page 5 the list of questions that the members were asked regarding these drug products, and without giving names, I have provided a tally of how many said yes or no in red text below each question. Again, upon referring to the guidance document listed above, you will note that the direct financial interest is generally the most important consideration that could limit a nominee's participation in the panel.(In the attached form used for this panel, please refer to question 3.)As you can see, all members replied "no" to question 3.

You will also note that most members have had some involvement with the industry that markets SSRI's. However, their specific involvement, which we cannot disclose, was not related specifically to the use of SSRI's in the paediatric populations.

I hope that this information meets your needs. Please do not hesitate to contact me if you have further questions.


Marilyn Davis
Manager, External Scientific Consultation
Gestionnaire, la Consultation Scientifique Externe
Office of Science, TPD / Bureau de la science, DPT
Tel: 613-957-6260
Fax: 613-941-5035

(See attached file: SAP-SSRI_COI summary.doc)


Page 5 of the doc reads thus:

Conflict of Interest Checklist
[pertaining to SSRI & SNRI]

SSRI & SNRI teleconference
February 20, 2004

Please check the appropriate response for each of the following questions and provide additional details as needed. Use a separate sheet of paper if required.

1. Have you:

a) had any direct dealings with a pharmaceutical manufacturer which sells SSRI or SNRI products? Yes 5 No 1

b) participated as the principal investigator in research, scientific studies or clinical studies related to SSRI or SNRI? Yes 5 No 1

c) participated (does not include attendance) in seminars or promotional meetings that dealt with SSRI or SNRI? Yes 4 No 2

d) authored or co-authored or do you have in preparation any scientific paper or other document concerning SSRI or SNRI? Yes 4 No 2

If Yes, please provide a copy of the manuscript or journal citation.

2. Have you attended conferences and meetings where all or part of the travel and accommodation costs were paid for by a manufacturer of SSRI or SNRI?
Yes 2 No 4

If Yes, please give the dates and details.

3. Do you own shares apart from mutual funds in one or more pharmaceutical companies manufacturing SSRI or SNRI? Yes 0 No 6

If Yes, what is their current value?

NAME OF COMMITTEE: Scientific Advisory Panel on SSRI & SNRI

Full doc can be downloaded HERE


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