Health Canada appointed paid consultants of manufacturers to independent r

[Guest guest]

Bravo to all involved and thank you!

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

From Women and Health Protection

September 21, 2005

Financial conflict of interest for members on breast implant

advisory panel unacceptable

Health Canada appointed paid consultants of manufacturers

to " independent " review body

Public hearings to be held next week

Three members of the advisory panel appointed by Health Canada to

review the possible re-approval of silicone breast implants for the

Canadian market have ties to the manufacturers, and the government

does not appear to have any intention of removing them before the

public hearings taking place September 29, 2005.

" This is an unacceptable conflict of interest that questions the

legitimacy of the whole process, " says Prof. Abby Lippman of McGill

University and member of Women and Health Protection, a working

group that monitors the regulatory activities of Health Canada for

their impact on women's health. " What is the point of collecting

information about conflict of interest and then doing absolutely

nothing about it? " she adds.

Applications have been submitted to Health Canada by Inamed and

Mentor for the reintroduction of silicone breast implants, and are

currently under review. Health Canada has asked the panel to advise

the House of Commons Standing Committee on Health about the safety

and efficacy profile of the products based on scientific, medical

and clinical evidence. However, the panel was also asked to declare

any conflicts of interest prior to their participation on the panel.

According to the Canadian Medical Association Journal, three panel

members admitted to receiving funds directly from the manufacturers

whose products are under review.

Dr. Harold from Washington University in St. Louis Missouri

and Dr. Brook from McMaster University in Hamilton were

paid by Inamed to provide information to FDA advisory panel members

supporting Inamed's application for approval to sell the same style

of silicone gel breast implants at the FDA's meeting this past

April. This was only one month after their participation on a Health

Canada secret panel meeting on breast implants, and just five months

before being appointed to the current Health Canada panel to

consider silicone gel breast implants.

Dr. Brown of Sunnybrook and Women's College Health Sciences

Centre in Toronto has also received funding to take part in the

promotion of products made by the manufacturers of the silicone

implants under review. Advertising for his clinic that recently

appeared in a cosmetic surgery supplement in the Globe and Mail

promotes the wide-spread use of the unapproved silicone gel implants

(09/14/05). Also, a recent journal article of which Brown is the

lead author states that: " Cohesive gel implants are likely to play

an important role in aesthetic and reconstructive breast surgery

when silicone gel implants are reintroduced into the North American

market " (Plast. Reconstr. Surg. 116: 768). It sounds as if Brown

considers the approval process a foregone conclusion. Could his

bias be more clear?

" You would be hard pressed to find a more glaring, outrageous

conflict of interest other than having the CEOs and full-time

scientists of Inamed and Mentor on the panel, " says Dr.

Zuckerman of the Washington-based National Research Center for Women

and Families. " What are Health Canada officials thinking? There is

absolutely no way to justify their participation on the panel with a

straight face. "

Dr. Zuckerman was responsible for the US Congressional investigation

of the lack of safety data on breast implants in the early 1990s,

and testified at the FDA panel meetings on silicone gel breast

implants in 2003 and in April 2005. In the spring of this year, she

met with officials at Health Canada to discuss the need for a

transparent process in Canada that made room for consumer and expert

input. She was taken aback to read that three industry-sponsored

consultants were appointed to the panel. " It flies in the face of

everything we know about having objective scientific review, " adds

Zuckerman.

Canada repeating mistakes of FDA

According to the New England Journal of Medicine, and Brook

served to promote industry interests on the US FDA advisory panel

for silicone implants. The US Senate Health Committee is

investigating the FDA advisory panel on breast implants for possible

conflicts of interest.

The announcement that these consultants will also be sitting on what

is supposed to be an independent advisory panel for Health Canada

at the end of September is cause for concern to Joyce Attis, a

founding member of the Breast Implant Line of Canada, a support

group for women who have had breast implants.

" The Senate in the US is probing the Breast Implant Advisory Panel

conflict of interest. Kudos to them for following through on this

important issue. Will our government follow suit and address the

fact that there are three members of the breast implantadvisory

committe who were paid as consultants by the very two applicants

attempting to get their silicone gel breast implants back onto the

Canadian market? Something smells here. Let's clean up the stench! "

Continued safety concerns with silicone implants

Silicone breast implants were withdrawn from the Canadian market in

1992 after serious safety concerns were raised. A series of

successful lawsuits against the manufacturer followed. The move by

Inamed and Mentor to reintroduce an ostensibly improved model of the

silicone gel breast implant on the Canadian market has many health

and women's organizations very concerned.

" Silicone gel breast implants have greater risks than saline

implants, with no long-term safety data available from either

company submitting its application to Health Canada, " says Anne

Rochon Ford, Coordinator of Women and Health Protection. " This is

problematic asthe more serious health concerns with these implants -

mostly related to rupture -- tendnot to show up right away. "

A study of silicone implants conducted by FDA scientists in 2000

reported a failure rate of 55% per implant in women who had breast

implants for augmentation for an average of 16 years.

Other studies show much higher rates of rupture, pain, and other

complications among breast cancer patients using implants after a

mastectomy. " More and more women receiving implants at a young age

may anticipate multiple surgeries with added financial burdens, "

says Ford. " Teenaged girls are receiving them as birthday and

graduation presents from their parents, " adds Ford. " Does Health

Canada really want to be condoning such misguided promotion of a

distorted body image amongst young women and girls, especially with

a product with such a dubious track record? "

Research conducted at the British Columbia Centre of Excellence for

Women's Health (BCCEWH) also documented the growing costs to

provinces as more women develop complications from breast implant

surgery, and return continuously to the health care system for

additional surgeries and other interventions and treatment related

to implant rupture. " Would any other medical device that failed in

more than half the people in which it was used and that itself

created so many significant problems ever be approved? " asks Lippman.

Public consultation process also flawed Health Canada has invited

the general public to take part in the review of silicone breast

implant applications by asking individuals and organizations to

register to present their viewpoints and evidence to the Health

Canada appointed expert review panel, or by commenting in an online

forum.

However, in order to adequately comment on the applications, the

public needs to see the industry data on silicone implants, which

was not made available to the public on Health Canada's website

until September 13, 2005. Registration for public participation was

originally due September 9, and then extended to September 16,

leaving only 3 days for organizations and individuals to review the

data and register.

" The government has made a multitude of claims about a commitment to

transparency in the drug and devices regulation process, " says

Ford. " Transparency must include information about the products in

time for people to make substantive comments. This is a violation

of public trust. "

For interviews, contact:

Anne Rochon Ford, Coordinator

Women and Health Protection, www.whp-apsf.ca

(416) 712-9459

whp-apsf@...

Prof. Abby Lippman

McGill University

Joyce Attis, President

Breast Implant Line of Canada

Zuckerman, Ph.D., President

National Research Center for Women & Families,

www.center4research.org

For Health Canada's website about the breast implant

panel:

http://www.hc-sc.gc.ca/english/protection/implants/index_e.html