Mrs. Eloise Jones (Saskatoon):
Mr. Speaker, by virtue of Standing Order 26 I would ask leave to move the adjournment of the House for the purpose of discussing a definite matter of urgent public importance. Last November in a meeting of the Special Committee on Food and Drugs I made mention of the concern of my fellow medical practitioners about the long term effects of some of the potent drugs we are now using in the treatment of psychiatric patients. I referred then to a paper delivered to the Canadian Psychiatric Association making observations about skin pigmentation problems following long-term treatment on high dosages of the medication known generically as chlorpromazine. I referred also to a report in the Journal of the Canadian Medical Association on liver damage, and deaths resulting from the use of this drug.
Use of Chlorpromazine
At that time I asked the witness drug manufacturer, who was not the original developer of the drug, about his studies and clinical testing of his product. He stated that he had none; that he was not making, nor did he seem to intend to have made, any clinical studies on the ground that this was only the responsibility of the original developer. I also discovered that this manufacturer had no staff physician to whom physicians could immediately refer if they encountered some unexpected side effect in the use of this potent drug.
Medical integrity insists that the best interest of the patient is served by treating him with medicines compounded under the most scrupulous conditions, that have been clinically proven for efficacy as to purity, solubility and stability of the active chemical and the dosage form offered to the patient, whose supplier's processes are under continuous medical supervision, and who have a staff physician available continuously for consultation by the patient's physician in the event of unexpected reactions.
It was my intention to wait until the deliberations of the Committee of this House offered an appropriate moment to accent this problem and concern. But in a recent issue of the Canada Gazette, part I of May 8, I observed a notice that a chemical company was applying to the Commissioner of Patents for the right to a manufacturing patent developed by another pharmaceutical house. As I understand it, there is no legal block to the Commissioner ordering this. As it is not regarded as a new drug, the Federal Government requires no clinical tests, no studies, no reporting of any nature of the dosage form to be presented, simply the right to compound the chemical.
Yet this is even more potent a drug than the one with which the scientists were concerned at the Canadian Psychiatric Association. Trifluoperazine, as I discovered the application to concern, is the most potent of all the potent phenothiazines. The tablet form of it never contains more than 10 milligrams of the active ingredient. The present manufacturer's literature states that:
At the dosage levels used in mental hospitals, neuromuscular reactions are seen in a significant number of patients. These side effects are manifested not only as a transient stimulation or jitteriness, but also as dystonias, or pseudo-Parkinsonism.
Obviously it must not only be administered with great care, but the physician and patient must know that it is manufactured under the
June 4, 1965
Use of Chlorpromazine conditions and to the standards upon which medical integrity insists.
I submit therefore that this is more-much more-than a simple patent matter to be settled by even good technicians. I hold no brief for the owners of the patent per se. But I do hold a brief for the protection and welfare of the Canadian people. So I urge the Minister to bring this immediate matter into the purview of her Department and also all future applications for the licensing of potent medicines made under patent; or I urge that all arrangements between the owner of the patent to make potent medicines and other drug manufacturers shall be conditional upon:
(a) Being in possession of a certificate indicating that the proposed new producer complies with the manufacturing standards of the Food and Drug Directorate of Canada;
(b) That the new producer is in possession, and prepared to submit evidence to the Food and Drug Directorate of Canada, of studies of a controlled laboratory of a clinical nature demonstrating safety and availability or efficacy of the dosage form offered;
(c) That the dosage form employed in the aforementioned studies shall have been manufactured by the same method and process as that proposed to be sold by the applicant;
(d) That the processes of the proposed new product are under the medical supervision of a physician licensed to practice in Canada and that a physician on the full time permanent staff of the applicant is available for consultation at any hour by any physician in practice in Canada or by the Food and Drug Directorate.
I, and other physicians in medical practice, realize that the drugs we have have proven efficacious when made under the supervision of the medical profession. Yet they can be a two-edged sword. So for the sake of the people of Canada I ask the Minister to act now, under an emergency order if necessary, and set strict standards before we encounter a situation that should-and could-have been prevented.
Subtopic: EXTERNAL AFFAIRS