9-28-05, 10:42 am

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 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 implant advisory 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 as the more serious health concerns with these implants – mostly related to rupture – tend not 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.'

From Women and Health Protection