Ottawa funds breast implants, refuses AIDS drugs

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Ottawa funds breast implants, refuses AIDS drugs

Sharon Kirkey, CanWest News Service

Published: Tuesday, June 06, 2006

A leading Canadian AIDS researcher and doctor says he

is " morally outraged " that Health Canada has approved

more than 21,000 requests for banned silicone breast

implants but continues to deny patients with advanced

HIV access to potentially life-saving drugs.

''Let me be perfectly clear: I have no problem with

women accessing this program whatsoever,'' Dr. Julio

Montaner, director of the B.C. Centre for Excellence

in HIV/AIDS, says. ''But, to us, this is a sort of

perverted irony.''

Health Canada's Special Access Program (SAP) is

designed for patients with serious or life-threatening

conditions who require emergency or compassionate

access to drugs or treatments not licensed in Canada.

Another separate program covers medical devices.

Doctors can apply to have devices released for

emergency cases or when conventional therapies " have

failed, are unavailable or unsuitable to treatment. "

Montaner says he was ''flabbergasted'' to learn

through a Global National report in February that more

than 21,000 requests for silicone implants have been

approved. According to new figures provided to CanWest

News Service Monday, as of June 5, Health Canada had

released 26,000 breast implants through the special

access program.

''With all due respect for women who need breast

implants, I think that nobody can deny that emergency

access to anti-retroviral therapy for people with

advanced disease may be a bit of a priority over and

above the accessing of these silicone implants,''

Montaner says.

In a letter published in today's Canadian Medical

Association Journal, Montaner and health care ethicist

Christie describe applying in April 2005 for

emergency access to two experimental drugs on behalf

of six HIV-positive patients who had become resistant

to all conventional treatments. ''SAP denied our

application and all appeals,'' they write.

''One of our patients died during this 10-month

battle, but no one has ever died from ''small

breasts'' or ''slight rippling of the skin'' from

saline implants.

''Without disparaging the difficulties experienced by

women who need breast implants, we cannot contain our

moral outrage at the ineffectiveness of the SAP in

dealing with this truly life-threatening matter.''

A Health Canada official says that at the time, there

was no evidence to show that the drugs, when used

together, would be safe and effective.

Following public pressure, Health Canada eventually

approved the medicines, TMC125 and TMC114, through a

special clinical trials program. Five patients began

treatment in January.

''Every one has tolerated the regimen extremely

well,'' Montaner said in an interview. ''There have

been no significant side effects of any kind. The

virological and immunological responses have been

extremely gratifying.''

He says he could ''come up with a dozen people

tomorrow'' who might benefit from the drug combination

but who do not qualify for the clinical trial. But,

''it continues to be very difficult to access these

kind of medications for people who need them.''

''At the end of the day what really troubles me is

that there is no sense of accountability on the part

of the SAP.''

Montaner, who begins his term as president-elect of

the International AIDS Society at the international

AIDS conference in Toronto in August, says the issue

goes beyond HIV and AIDS, and could affect people with

cancer, Parkinson's disease and other life-threatening

illnesses.

Dr. Supriya Sharma, associate director of Health

Canada's therapeutic products directorate, says new

information about the use of the experimental HIV

drugs has become available since Montaner first made

his request last April.

''We're not saying that if a request came in to

special access that we wouldn't consider it for those

two drugs, " she said.

skirkey@...

© CanWest News Service 2006