Bravo to all involved and thank you, Zee.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
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 Brandon from Washington University in St. Louis Missouri
and Dr. Michael  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. Mitchell 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. Diana 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, Brandon 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@web.ca

Prof. Abby Lippman
McGill University

Joyce Attis, President
Breast Implant Line of Canada

Diana 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