October's Ontario Provincial Elections Are Last Window of Hope For Many Cancer Patients

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The plight of Ontario's citizens with cancer only seem to be heard in those critical few days and weeks prior to an election, after which it reverts back to deaf ears. This will happen at this week's critical elections. Life saving cancer curing drugs made within Ontario's own borders, cannot make it through the province's beaurocratic red tape, while a multinational pharmaceutical from the States enjoys a monopoly. Deceased cancer patient, Gloria Knezic, is not so much a victim of a disease as she is a victim of regulatory entanglements.

A lot hands in the balance this week at the Ontario elections. Cancer patients need a sympathetic ear from elected officials to assure the best care and drugs are available, and to make the Ministry of Health abide by the laws of Bill 102.

In March of 2005, 53-year-old Gloria Knezic, a vibrant, intelligent, university educated nurse, noticed a change in her health and upon the insistence of her mother went for a gynecological exam. An irregularity then led to a series of testing which confirmed she had contracted life threatening endometrial and peritoneal cancer.

Although other countries were currently using chemotherapy for this type of cancer, radical surgery and standard radiotherapy were the only therapies allocated in the Ontario health plan for this type and stage of cancer.

After having no success in lobbying the province to pay for her form of treatment she was on her own. Undaunted, she began her own research to find proper and affordable treatment. One solution was to go to the U.S. but, at $30,000 -$40,000, that proved cost prohibitive on a long term care facility nurse's salary.

Lorraine Knezic age 80, Gloria's mother said in a recent interview that "my daughter didn't fight the system the system fought her". Gloria then, by sheer coincidence, discovered there was a pharmaceutical company, in her hometown of St. Catharines, with a federally approved cancer drug to treat her type of cancer.

The firm, Biolyse Pharma Corporation (http://www.biolyse.ca), has been providing world markets with Paclitaxel for Injection since 1997. The product was developed in Canada, and was administered in a Canadian clinical trial setting for the first time in 1994. Since receiving its Health Canada approval, the company has been providing Paclitaxel for Injection throughout Canada. Although the company is allowed to sell in Ontario, the product has not been approved for reimbursement in this province.

Gloria contacted Biolyse and received a warm reception from its CEO, Brigitte Kiecken, and a pledge to help her receive the affordable drug, paclitaxel, through her pharmacist for less than $1,000. Gloria worked to receive the cooperation of the Hotel Dieu Hospital, which was just days away from joining the Niagara Health System, to properly administer the drug treatment.

Regrettably, the treatment was started much too late to save her life. Sadly, Gloria passed away on January 18, 2006. Paclitaxel gave her comfort and quality of life in her final days and allowed her to continue working during the treatment, but more so than anything, it gave her hope and a shot at life.

Gloria's story is overtly symptomatic of a flawed government -- one that has violated its mission to protect its citizenry.

The System is Broken
As of this date, although Biolyse's paclitaxel has passed the federal Ministry of Health's stringent approval process, and Biolyse is the exclusive provider of this vital chemotherapy treatment for British Columbia, Saskatchewan, Alberta, and Québec as well as other foreign countries, it has only run into logger jams with the Ministry of Health in Ontario with no plausible explanation.

Since 1991, Biolyse has filed three times for approval to Ontario's Ministry of Health, and all three times have been rejected without comment. "We have been stonewalled in Ontario with no scientific reasons given", said Biolyse's Kiecken, "While mega-giant, Bristol-Myers Squibb enjoys a monopoly in our province for a similar drug."

Biolyse is the originator of the natural chemotherapy drug, paclitaxel from Taxus canadensis. It is equivalent to that of Bristol-Myers Squibb's Taxol©. The Federal Ministry of Health found paclitaxel and Taxol© to have the same degree of safety and efficaciousness.

This means that in the eyes of the federal agency, both drugs are effective and provinces could base their purchasing decisions on price. Unfortunately, even if the Ontario hospital system would favor Biolyse paclitaxel, they would not be refunded for its procurement. In fact, this past April, Bristol-Myers Squibb was stocked out of Taxol©, and hospitals were clamoring for the readily available paclitaxel from their own back yard, but the Ontario Ministry of Health would not yield.

Through a fair competitive bid process Biolyse now supplies amongst other Canadian provinces, all of the hospital centers in the province of Québec. The competition between paclitaxel providers has permitted these hospitals to triple their procurements in the last two years.

"This is not likely to happen here" says Kiecken, "Keeping the Biolyse product off the list in Ontario is keeping competition away making buying groups vulnerable to price hikes"

It appears that some effort was made to correct Ontario's Ministry of Health's unaccountable behavior. In June 2006, Bill 102, The Transparent Drug System for Patients Act was passed to infuse discipline and transparency into the department's decision-making process. As of this date, the edicts of the bill have not been implemented.

A Challenge to Elected Officials
With the elections to occur this Wednesday. It is time for pledges by both candidates, James Bradley and Bruce Timms to fix a system that is not only an embarrassment to Ontario but is costing lives and taxpayers money.

The provincial Conservative candidate for St.Catharines Bruce Timms, agrees "The provincial drug regulation is a mess, it's time for a change". Mr. Bradley the Liberal candidate, was not available for comment.

It is estimated that in the past five to six years, that Biolyse's paclitaxel, a cost effective, efficacious cancer drug could have benefited approximately 40,000 cancer stricken citizens of Ontario.

"It's unfortunate, but the only time cancer patients can get news coverage in a country that is rich like Canada, and rich like Ontario, one of the most affluent places on the planet, is a week before the election", said Kiecken, "That is a symptom that something is wrong."

How many more Gloria Knezics will it take before corrective action by our elected officials is finally taken?

About Biolyse Pharma
Biolyse Pharma, established in 1980, is located in St. Catharines, Ontario. Biolyse focuses on the extraction, concentration and purification of bioactive compounds. Biolyse defines its mode of operation through its name, meaning "the separation of biological substances into their component parts." http://www.biolyse.ca.

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John Fulton
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