Asparaginase And Health Canada

Yesterday, the CBC released a story informing Canadians of the possibility of introducing a new “additive” to the foods Canadians eat called Asparaginase. Asparaginase is a “cancer fighting” drug, which the CBC incorrectly refers to as an additive. The purpose of this introduction, would be to fight off a chemical byproduct called Acrylamide, which is thought to be produced when carbohydrates, in foods such as bread or potatoes, are cooked at high temperatures.

According to the CBC article, the evidence that Acrylamide causes cancer is not readily abundant in humans, although it has been found in some studies concerning mice. With this finding, the Government is looking to combat this slight possibility by introducing Asparaginase in to our foods.

Health Canada is open to public comments from December 9 to February 21. You can find the public consultation information here. I am unsure as to why this story has been released on the 22nd of December.

The purpose of this blog is to discuss the use of Asparaginase, to provide information to those who are interested in exactly what this product is, and to provide resources to those who wish to NOT have this product added. I fully encourage all to email Health Canada to voice your displeasure over this possibility.

What Is Asparaginase

“Food manufacturers say adding it could bring down levels of acrylamide in heated foods since the enzyme breaks down the acrylamide.”

According to the Health Canada public consultation, their website states:

Health Canada’s Bureau of Chemical Safety has recently completed a detailed safety assessment of the enzyme asparaginase after receiving petitions requesting that the Food and Drug Regulations be amended to include this enzyme produced by 2 separate microbial sources: Aspergillus oryzae (pCaHj621/BECh2#10), and Aspergillus niger ASP72.

The cause of the possibility of this product being officially added as a food additive was due to Health Canada receiving petitions that the Food and Drug Regulations be amended to include this product. It makes no mention of Food manufacturers. I have recently submitted a Freedom of Information request in to this particular petitions and will post all info as I receive it. I do feel, however, that someone other than Food manufacturers may be interested in having this product added.

What CBC fails to mention is the well marketed name for Asparaginase. The product, on the shelf, is called Elspar. Elspar is manufactured by Merck. You can read the information on Elspar directly from Merck. In case you are a little short on time, I’ve summarized some points regarding this specific document:

It is recommended that asparaginase be administered to patients only in a hospital setting under the supervision of a physician who is qualified by training and experience to administer cancer chemotherapeutic agents, because of the possibility of severe reactions, including anaphylaxis an sudden death.

In a significant number of patients with acute leukemia, particularly lymphocytic, the malignant cells are dependent on an exogenous source of asparagine for survival. Normal cells, however, are able to synthesize asparagine and thus are affected less by the rapid depletion produced by treatment with the enzyme asparaginase. This is a unique approach to therapy based on a metabolic defect in asparagine synthesis of some malignant cells. ELSPAR, derived from Escherichia coli, is effective in inducing
remissions in some patients with acute lymphocytic leukemia.

While I am certainly not a doctor, if I understand the above quote correctly, it says that normal cells are able to synthesize asparagine, while those with leukemia are dependent on an external source of asparagine. This drug is for those who have leukemia, and does not appear to be one to combat it, nor to combat cancer.

ELSPAR is indicated in the therapy of patients with acute lymphocytic leukemia. This agent is useful primarily in combination with other chemotherapeutic agents in the induction of remissions of the disease in pediatric patients.3,4 ELSPAR should not be used as the sole induction agent unless combination therapy is deemed inappropriate. ELSPAR is not recommended for maintenance therapy.

In otherwords, Asparaginase should not be given for maintenance, nor given on it’s own, rather, it should be given in combination with other chemotherapeutic drugs.

Allergic reactions to asparaginase are frequent and may occur during the primary course of therapy. They are not completely predictable on the basis of the intradermal skin test. Anaphylaxis and death have occurred even in a hospital setting with experienced observers.

In view of the unpredictability of the adverse reactions to asparaginase, it is recommended that this product be used in a hospital setting. Asparaginase has an adverse effect on liver function in the majority of patients. Therapy with asparaginase may increase pre-existing liver impairment caused by prior therapy or the underlying disease. Because of this there is a possibility that asparaginase may increase the toxicity of other medications

Unpredictible adverse reactions? Adverse effect on the liver? May increase the toxicity of other medications?

Asparaginase has been reported to have immunosuppressive activity in animal experiments.

L-asparaginase has been reported to interfere with the interpretation of thyroid function tests by producing a rapid and marked reduction in serum concentrations of thyroxine-binding globulin within two days after the first dose. Serum concentrations of thyroxine-binding globulin returned to pretreatment values within four weeks of the last dose of L-asparaginase

Some rabbits that died showed small thymic and lymph node hemorrhages and necrosis of the germinal centers in the lymph nodes and spleen.

While the Government is concerned over acrylamide causing cancer in mice, the negative impacts on mice and other animals given Asparaginase have been equally terrible. Why would they want to add this product to our food if animal studies show many negative impacts? Does this make sense?

In mice and rats ELSPAR has been shown to retard the weight gain of mothers and fetuses when given in doses of more than 1000 I.U./kg (the recommended human dose). Resorptions, gross abnormalities and skeletal abnormalities were observed. The intravenous administration of 50 or 100 I.U./kg (one-twentieth or one-tenth of the human dose) to pregnant rabbits on Day 8 and 9 of gestation resulted in dose dependent embryotoxicity and gross abnormalities. There are no adequate and well-controlled studies in pregnant women. ELSPAR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Allergic reactions, including skin rashes, urticaria, arthralgia, respiratory distress, and acute anaphylaxis have been reported. (See WARNINGS.) Acute reactions have occurred in the absence of a positive skin test and during continued maintenance of therapeutic serum levels of ELSPAR.

Pancreatitis, sometimes fulminant and fatal, has occurred during or following therapy with ELSPAR.4-7,20 The complications of pancreatitis, including pancreatic pseudocyst and hemorrhagic pancreatitis, have also been reported.

Asparaginase is not a food additive currently, nor should it be. It is currently used as a medication to TREAT leukemia, not to prevent it. Why would anyone in their right mind approve this, and start to call it a food additive? Do you really want this in your food?