Breast Implants Public Forum: Concerns about Health Canada's Process

Note that the deadline for registering to present at the breast implant hearings in Ottawa on Spet 29 has been extended to September 16th. Go to Breast Implants Public Forum for more details.

Letter #1

Toronto
July 29, 2005

(sent via Breast Implant Forum website)

To Whom It May Concern

Having looked over the site for the breast implant forum and read the "Affiliation and Interest Summary" for the panel members, I have a question for which I cannot find an answer on the site. Three of the panel members have identified competing interests in terms of their affiliations with the manufacturers whose submissions are before them (Inamed, Mentor ). How will this be treated by Health Canada ? Will they have a different status from the other members? Will they be required to remove themselves from the group for certain parts of the discussion?

Your prompt response to this query would be greatly appreciated. Please reply to me as well as to Dr. Abby Lippman who is cc'd on this message.

Sincerely
Anne Rochon Ford

Anne Rochon Ford, Coordinator
Women and Health Protection
P.O. Box 291 , Station Q
Toronto , ON M4T 2M1
www.whp-apsf.ca

Response from Health Canada to Letter #1

Ottawa
August 10, 2005

Dear Ms. Rochon Ford:

This is in response to your enquiry dated July 29, 2005 , regarding
information provided in the "Affiliation and Interest Summary" for the panel members.

Scientific/Expert Advisory Panels provide independent, expert health and science recommendations that Health Canada uses in its regulatory decision making.

Guidance on conflict of interest is provided to potential members when discussing the appointment. Before appointment, all potential Panel members are required to submit conflict of interest declarations to disclose to Health Canada any circumstance that may place, or be seen to place, the member in a real, apparent or potential conflict of interest. All Panel nominees are screened for perceived, potential or real conflicts of interest in accordance with Health Canada 's Conflict of Interest Policy.

The membership of the Expert Advisory Panel on Breast Implants as a whole covers areas of relevant expertise and knowledge such as chemistry, materials engineering, radiology, epidemiology, plastic/reconstructive surgery, psychology, ethics, rheumatology, toxicology, surgical oncology and patient needs and experience.

The Panel members have been selected according to three core principles:

They are experts in their field, with expertise and experience that are vital to the ability of the panel to provide high-quality advice;

They have pledged to be objective: they will listen to the evidence presented and keep an open mind;
They have no vested interest in the panel outcome.

In seeking out a high level of expertise in issues such as those under examination by the panel, it is not unusual to find individuals who have had relationships of varying types with the product manufacturers. The expert community in Canada is a small one and the expertise that Health Canada has gathered for this panel is in high demand. Experts who are leaders in their fields or who possess unique combinations of expertise and experience are often asked to provide advice to various organizations, including non-government organizations, governments and drug manufacturers. To obtain the advice or participation of experts, manufacturers frequently cover the costs associated with travel and other expenses.

Several of the members of this panel have provided advice to, or have
participated in conferences or activities sponsored by the product
manufacturers. Panel members were selected to provide an appropriate balance of views on the panel. They were specifically asked to declare this type of information, affiliation or activities, as set out in the summary of each member's information posted on the Health Canada website. Other panel members have spoken publicly about issues related to the safe use of breast implants.

When deciding to include a panel member who may be, or may be perceived to be, in a conflict of interest situation, Health Canada considers the following:

- the panel has an advisory function only ? Health Canada makes the decision;
- a panel member is only one voice among many on the panel;
- the panel member has to disclose any affiliation or potential conflict of interest to the Chair of the panel who can take action if a member advocates a biased position during the discussions.

In addition to screening at the time of the appointment, at the opening of the meeting there is a round table declaration and discussion of the panel's conflict of interest and acceptance of the Terms of Reference as written. In situations where conflict of interest, or the appearance thereof, arises in the course of the work of a Panel member, the individual involved must declare its existence. It is the role of the Chair to manage the Panel's deliberations in light of conflict of interest that has been disclosed. This includes resolving differences that may arise during the meetings, ensuring that Panel members are given adequate opportunity to provide opinions addressing questions posed by Health Canada , seeking to achieve consensus and ensuring if consensus cannot be reached, it will be reflected in the Record of Proceedings with no attribution to Panel members. The Chair must also ensure the Record of Proceedings sufficiently captures the discussion of the day and provides clear advice to Health Canada .

I hope this addresses your concerns.

Sincerely,
Hripsime Shahbazian

cc: Abby Lippman

Revised: August 8, 2005

Letter #2

Toronto
August 29, 2005

Dear Ms. Shahbazian

Thank you very much for your response (sent via Ms. Chantal Tremblay) to my earlier questions about the breast implant panel process, specifically relating to conflict of interest of panel members. A few additional questions have arisen as our group moves ahead in preparing for the hearings.

1) Timelines for response
We have concerns about the very short turnaround time for individuals wishing to prepare a thorough and thoughtful response to complex scientific questions. Your site states:

"Please note the following important deadline : The last day to register to present in person to the Expert Advisory Panel is Friday, September 9, 2005 . All the written and on-line input received at that date will be submitted to the Panel members. You are welcome to provide input past September 9th so it can be shared with others on the website. This information will be reviewed on-line by the Panel members at their discretion "

By this we understand that if interested individuals want to have input into the process that is anything more than the allowed 3 minutes on September 29, and that is guaranteed to make its way to the panel members, they must submit their commentary by September 9. And yet, to date (August 29) we have not yet seen the details of just what it is we are being asked to comment on. Indeed, we do not even know which products are under consideration. Presumably, the manufacturers will be supplying the public with information about the products in question, but nowhere on your site does it tell us when to expect that information. How can citizens be expected to provide substantive responses when at less than two weeks before the deadline, nothing about the products under review is up on the site?

2) Limitations of expected responses
The website provides a series of questions limited to the safety and effectiveness of silicone gel breast implants: preclinical data, clinical data and labelling. We understand that these are the areas that are mandated for consideration through the Food and Drugs Act and Medical Devices Regulations . And yet, as Health Canada staff and members of the panel are aware, discussions of these implants "in the real world" are taking place against a backdrop of concern about healthy body image, within much larger population health and women's health discourses. Are experts in the fields of sociology, psychology, psychiatry and gender studies - with important information to offer for the panel's consideration - expected to constrain their input to conform to these limitations? We would expect not, though this is not clear from the information on the site. What assurances does this much larger body of experts have that their input will be heard equally by the panel and by Health Canada ?

3) Issues relating to in-person presentations
i) We understand that those who request to make presentations must confine their oral delivery to a maximum of 3 minutes. Time restrictions are understandable in the event that a large number of people come forward wanting to present and, presumably, the time allotted has been based on calculations of an expected number of applicants and a reasonable amount of time that panel members can be expected to sit. If the numbers are lower than expected once the Sept 9 deadline for registration has passed, is there any chance this time restriction might be loosened? Frankly, we find it unfathomable how a learned expert in any field could say anything meaningful about this complex scientific and social issue within such a short timeframe.
ii) Are any provisions being made to cover travel and accommodation expenses for those registering to present? While we realize that participants may not need to stay in the same hotel that the hearings will be taking place in, it would be convenient to be on site; we find it regrettable that the venue chosen is one of the most expensive hotels in Ottawa .

4) Who can present
It is noted on the website that "priority will be given to presenters who are Canadians and residents of Canada ." While we support this focus within reason, we would be disappointed if the intelligence on this issue from other countries was completely lost in the process. Can you explain more clearly what this means for non-Canadians who wish to present? For example, is it conceivable that if large numbers of Canadians come forward to register, possibly no non-Canadians will be allowed to present, and how will that decision be made? If non-Canadians submit written input before September 9, will their input be passed on to the panel members for their deliberations?

Thank you for your consideration of our questions. We hope to hear back from you soon.

Anne Rochon Ford
Women and Health Protection
Toronto ON
www.whp-apsf.ca

Response from Health Canada to Letter #2

Ottawa
September 13, 2005

Dear Ms. Rochon Ford,

Thank you for your correspondence of August 29, 2005 . Health Canada is
happy to have the opportunity to provide further clarification to the
issues you have raised regarding the public forum process on silicone
gel-filled breast implants. Please find enclosed responses to your
questions:

1. Timelines for response
Health Canada received the manufacturers' information on September 12 and now that information is available on the HC website. Provision of this information by the manufacturers is voluntary. Health Canada appreciates that the public may need additional time to assess this information and has therefore extended the following deadlines:

In-person presentation to the Expert Advisory Panel:
- Deadline for registration has been extended to Friday, September 16, 2005 .
- Deadline for presenters to provide Health Canada with their final presentation and other material: September 21, 2005

On-line or in writing input to the Expert Advisory Panel:
- Deadline for submitting input on-line or in writing is September 21, 2005, in order for it to be provided to the panel for their review. - Input received after September 21, 2005 will be shared with others on-line and will be reviewed on-line by panel members at their discretion.

The above information was posted on the Health Canada website on September 9th, 2005

2. Limitations of expected responses
The public forum process is designed to provide an equal opportunity to speak and input to all those who have expressed an interest in participating. The Panel is mandated to provide advice on the questions posed by Health Canada and the public is encouraged to address the same questions in their input. However, the Panel will hear all relevant information on this issue and take it into consideration in its final recommendation to Health Canada .

3. Issues relating to in-person presentations
i) Health Canada anticipates having a considerable number of registered participants by September 16th which will not allow us to change the time limit for the public presenters. However, public presenters who wish to provide additional information to the Panel, apart from their presentation slides, can do so by submitting their material in writing by September 21st deadline.

ii) We regret to inform you that Health Canada is not resourced to cover any travel related expenses for the registered participants. Members of the public, who cannot participate in person, can provide their input via the written ( paper or on-line) consultation process. This strategy will allow for a broad range of the Canadian public to participate and provide their views.

4. Who can present
In order to maintain the focus of the Public Forum on the Canadian context, priority will be given to Canadian presentations. This means that any non-Canadian will be confirmed as presenters after all Canadian registered participants are accommodated. However, non-Canadians can provide their input on-line and if received prior to September 21st, it will be forwarded to the Panel members for their consideration.

The public forum is a relatively new practice for Health Canada and a learning experience for all involved. Health Canada is committed to openness and transparency in its decision-making process and, as we progress towards that goal, we will evaluate the Expert Advisory Panel meeting and public forum. Lessons learned will contribute to the current policy development work that the Department is undertaking on this type of public involvement mechanism. We would welcome input from you as part of this evaluation process.

I trust you will find that the information provided in this letter addresses your questions. Please do not hesitate to contact me at 946-4629 or Susan Gardner-Barclay, OCAPI's Director General at 946-6540, should you have any further questions.

Yours Sincerely,
Dhurata Ikonomi

___________________________________________
Dhurata Ikonomi
Senior Public Involvement Officer/Agente principale d'implication publique
Office of Consumer and Public Involvement / Bureau de la participation des
consommateurs et du public
Health Canada/Santé Canada

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