VANCENASE THE POLITICAL PROCESS
Has government decided in blood feud between Red Cross and Connaught? SARAH HENRY
The 2-year battle between the Canadian Red Cross Society and Connaught Laboratories Limited over control of future plasma processing in Canada has emerged as a sharply divisive and emotional issue within the health care field. Conflicting ideologies and reciprocal charges of inefficiency and factual distortion have left an aftertaste of bitterness and distrust. The federal-provincial committee, set up in 1976 to study plasma fractionation in Canada, has passed along its recommendations to the two levels of government and, by year's end, the Red Cross hopes to learn whether its bid for a $20 million plasma fractionation plant has been successful. And Connaught will know whether it has lost a relatively lucrative division which it says showed a 6% profit on $4.5 million in sales last year. If it gets the go-ahead, the Red Cross says the plant will be in operation by 1982, will pay for itself in 6 years, then provide plasma processing at a lower cost than Connaught, a projection Connaught flatly says is impossible. Blood relations The blood feud, and government's involvement in it, takes on an added dimension in light of both Connaught's and the Red Cross's firstcousin relationship to Ottawa. The Red Cross blood transfusion service receives almost all its funding ($32 out of $34 million last year) from federal-provincial grants; Connaught is owned by ConnLab Holdings Ltd., which in turn is controlled by the
Canadian Development Corporation, a crown corporation answering to the minister of finance. The Red Cross's position is an amalgam of ethical and economic considerations. A national non-profit approach to the collection, processing and distribution of blood products, it maintains, would protect the volunteer system from commercial intrusion and promote Canadian self-sufficiency, thus reducing Canada's reliance on imports and consequent vulnerability to international blood shortages. "We're not dealing in nuts and bolts here, we're dealing with human blood from volunteer donors," says Dr. Roger Perrault, director of the blood transfusion service and architect of the Red Cross proposal. "We don't want profit made in this area and Connaught is a profit corporation... Connaught has said that if it lost fractionation it would have to increase the price of insulin and vaccines. That shows there are a lot of things that fractionation is picking up in terms of overhead on other products. We feel human plasma and animal products should not be lumped together on a profit basis." Dr. Perrault is also mindful that blood donations inevitably slump when any hint of profit reaches the public ear: "We are dealing with the 4% of the population who give blood to satisfy the needs of the whole country. The minute we are not totally responsible and ethical, we are in trouble." Connaught, under orders to be profitable, resents the Red Cross's depiction of its commercial activity as
(Beclomethasone Dipropionate Nasal Inhaler) IndIcatIons: VANCENASE Is Indicated for the treatmont of perennial and seasonal rhinitis, when tolerance to, or effectiveness of, conventional treatment is unsatisfactory. ContraIndications: Active or quiescent untreated pulmonary tuberculosis or untreated bacterial, viral and fungal infections. In children under the age of 6 years and in patients with known hypersensitivity to any of the ingredients of the preparation. WarnIngs: In patients previously on high doses of systemic steroids, transfer to VANCE NASE may cause withdrawal symptoms: tiredness, aches and pains, and depression. In severe cases, acute adrenal insufficiency may occur necessitating the temporary resumption of systemic steroids. The safety of VANCENASE in pregnancy has not been established. The use of VANCENASE during the first trimester of pregnancy is not recommended. If used during the second and third trimester, the expected bene its should be weighed against the potential hazards to the foetus. VANCENASE is not recommended for those patients with a history of recurrent nasal bleeding. Precautions: The transfer of a patient from systemic steroids to VANCENASE has to be very gradual and carefully supervised by the physician. The guidelines under Dosage and Administration should be followed. There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those patients with cirrhosis. Fluorocarbon propelants may be hazardous if they are abused deliberately. Inhalations of high concentrations of aerosol sprays has brought about cardiovascular toxic effects and even death especially under conditions. of hypoxia. However, evidence attests to the relative safety of aerosols when used properly and with ide. uate ventilation. VANCENASE is not to be used urin ga n asthmatic attack. Acetylsalicylic acid should be used cautiously in conjunction with corticosteroids in hypothrombinemia. Patients should be advised to inform subsequent physicians of the prior use of corticosteroids. During VANCENASE therapy, the possibility of pharyngeal candidiasis, atrophic rhinitis or other changes in nasal mucosa should be kept in mind. Corticosteroid therapy can cause decreased resistance to localized infection. Should nasopharyngeal infections occur during therapy, appropriate alternate treatment should be instituted. The replacement of systemic steroids with VANCENASE may unmask symptoms of allergies which were previously suppressed by the systemic drug. If hypersensitivity reactions occur during therapy, the drug should be discontinued. Adverse Reactions: The most frequently observed side effects were those consistent with what one would expect in applying a topical medication to an already inflamed membrane. These include mild transient burning and stinging which occasionally required discontinuance of therapy. Other side effects seen in patients treated with VANCENASE were: nasal irritation, nose bleed, sneezing, throat irritation and sore throat. Dosage and AdmInIstratIon: VANCENASE is to be administered by the intra-nasal route only. The usual dose for adults and children over 6 years of age is one metered dose (50 pg) into each nostril three to four times daily. Maximum dai.. dose should not exceed 20 metered doses (100 pg or 1 mg) for adults and 10 doses (500 pg or 0,5 mg) for ch IIdren. Subsequent dosage maybe modified according to patient response. Insufficient information is available to warrant the safe use in children under age 6. When VANCENASE is used concurrently with VANCERIL, the combined total daily dose should not exceed the maximum daily recommended dose of beclomethasone dipropionate. Physicians should emphasize to patients the need for the regular use and proper operation of the pressurized canister. It Is important in the use of the product that the nasal passages be clear before using VANCENASE. This may be done simply by blowing the nose or by taking other appropriate medical measures when necessary. Careful attention must be given to patients previously treated for prolonged periods with systemic corticosteroids when transferring them to VANCENASE, Initially, VANCENASE and the systemic steroid must be given concomitantly for 10-14 days, followed by a gradual withdrawal of the systemic steroids. Dose reductions should be at a rate not to exceed 1 mg (prednisone) every 10-14 days if close continuous medical supervision is not feasible. It may be possible to withdraw systemic corticosteroids more rapidly if the initial dosage was 7,5 mg daily of prednisone (or equivalent) or less, or if the patient is under close continuous medical supervision. In patients who are not able to completely discontiflue the use of systemic steroids, a minimum maintenance dose should be continued in addition to VANCENASE. Dosage Form: VANCENASE is a metered dose aerosol contained in a canister fitted with a specially designed nasal adaptor which delivers 50 pg beclomethasone dipropionate per metered dose. Canisters are filled to provide a minimum of 100 doses, or 200 doses depending on the dosage size specified. Product monograph available to health professionels on request. Schering Corporation Limited, Pointe Claire, Quebec, HQR 1B4. T.M. MEMER
1088 CMA JOURNAL/NOVEMBER 4, 1978/VOL. 119
"some sort of legalized vampirism," says executive vice president Alun Davies. "It really comes down to whether you believe making money out of sickness is bad or, in fact, earning your revenue out of people getting well is good. I say if you can make an honest living out of people getting well and by preventing disease which is what the medical profession and everyone else in the health care industry does - then there's nothing wrong with it. But then that's translated into making money out of blood." In its brief to government, the Red Cross says its relationship with Connaught underwent an about-face when Connaught Medical Research Laboratories, affiliated with the University of Toronto, became Connaught Laboratories Ltd. in 1972, because it "placed the Red Cross in the position of answering 1 million volunteer blood donors as to why profit should be made on their gift." This pronouncement lightly skips over Connaught's history with the Red Cross, a relationship that generated profit long before Connaught moved into the private sector. In 1963, 9 years after Connaught set up its fractionation plant to process Red Cross plasma, the two organizations agreed that Connaught could export excess supplies of plasma products. The Red Cross received 10% of the earnings to cover collection costs of the exported goods. Over the years this comfortable, though unpublicized, arrangement generated close to $7 million for Connaught, $700 000 for the Red Cross. This arrangement ended in 1974, after Connaught exported a $200 000 shipment of serum albumin at a time when Canada was said to have a serious shortage. It also coincided with Dr. Perrault's arrival at the Red Cross. He ordered an immediate stop to the practice and export controls were subsequently introduced to prevent a repeat of the incident. The Red Cross was badly stung when this discontinued arrangement came to public attention in 1976. "We weren't making any money on it, nor did we intend to. But even that 10% was criticized," says Dr. Perrault. The question of exporting surpluses still requires a government
The non profit credit card
.iAIdar.tazid. .w uw..W ww. - w
AGE AND TOTAL DAILY DOSAGE NOTE 6.0mg THISISTHE (12.0 ml)' TOTAL DAILY MEDICATION hto8years 8.0mg TOBEGIVEN (150m1)' 1N30R4 9tol2years 100mg DIVIDED (20 OmI)' DOSES 'Volume of Lomotil Liquid containing approxImate total daily dosage of diphenoxylate HCI. Adjustment of dosage downward should be made as soon as initial control of symptoms is accomplished. 2to5years
The Connaught counterproposal calls for a system whereby the blood transfusion would supply and transfer ownership of plasma to Connaught ("ludicrous," says Dr. Perrault) with a guarantee of product quality and quantity from both sides. Connaught would like to sell to the Red Cross, it says, at prices reflecting its production and overhead costs plus a margin similar to that accepted by the federal government in the swine 'flu program (an ironic comparison in view of the $2 million lawsuit Connaught is currently pursuing against Ottawa for non-payment for the final batches of swine 'flu vaccine). Anomalous position Connaught is in an anomalous position, expected to be profitable, yet faced with the responsibility of providing Canada with its biologicals, some of which are inevitably unprofitable. Its financial involvement with the Winnipeg Rh Institute provides an interesting illustration of the complex machinations required to make ends meet. The institute collects virtually all Canada's high titre Rh plasma and all its tetanus antitoxin plasma through plasmapheresis (donors are paid for their time rather than their blood), which it sells to Connaught for production of Rh and tetanus immune globulin. At the beginning of the year, Connaught doubled its selling price for Rh immune globulin to $15.50 a vial, a rate still only half the US price. The increase, according to the Rh Institute brief to the fractionation committee, was necessitated by the need to offset the price of tetanus immune globulin, a market Connaught and the institute entered because the federal government did not want Canada to be dependent on US supplies in emergency. US commercial fractionators frequently sell tetanus immune globulin for as little as $1.28 a vial on a large tender basis by underwriting the costs through the $60 to $80 they receive from the sale of albumin produced from the same plasma. Connaught has not been competitive in this market, partially because its yields are lower than those it gets from Rh immune globulin, but mainly because it has only been able to get the $30a-vial price for albumin that it has agreed to with the Red Cross. To
balance the scales, Connaught lowered the price it pays for tetanus antitoxin plasma to the point where the institute has a deficit of $20 for each kilogram it sells to Connaught, it doubled the price of Rh immune globulin and increased the price it pays the institute for each kilogram of Rh plasma by $100. Thus, the institute is receiving an inflated price for one product to offset a loss incurred from the sale of another. The institute, in its brief to government, notes: "In the context of a relatively small country with specific requirements the profit motive will either destroy the program or the company, if the company has to compete with licensed American commercial products." If the Red Cross proposal is accepted, the institute will likely become an arm of the blood transfusion service. Government decision The manner in which the Red Cross proposal has been handled has been viewed as heavy-handed and secretive by some private businesses in the field. They think government has favoured the proposal from the beginning and has only gone through the motions of listening to all sides. In June 1976, the Red Cross submitted its first brief, outlining its hopes to control a blood fractionation plant and become a manufacturer of diagnostic reagents. Three months later, the ad hoc committee on plasma fractionation was formed and authorized the Red Cross to spend $150 000 for a comprehensive feasibility and site study, to be conducted by a firm chosen by the Red Cross. Dominion Biologicals Ltd., an allCanadian commercial enterprise engaged exclusively in making blood bank diagnostic reagents, said in its brief to the committee that "it would be wiped out by implementation of the Canadian Red Cross proposal." And yet, Dominion says, it knew nothing of the plan until September 1977, well after the study by Surveyer, Nenniger and Chenevert Inc., was under way. Comments Dominion: "We suspect that officials of the Department of National Health and Welfare are, or have been, predisposed to the Canadian Red Cross proposal irre-
1094 CMA JOURNAL/NOVEMBER 4, 1978/VOL. 119
.j[ucopkAqF! INDICATIONS: To control hyperglycemia in Glucophage responsive, stable, mild, nonketosis prone, maturity onset type of diabetes which cannot be controlled by proper dietary management, exercise and weight reduction or when insulin therapy is not appropriate. Glucophage can beof value forthetreatmentof obese diabetic patients. CONTRA INDICATIONS: * Unstable and/or insulin dependent diabetes mellitus, history of ketoacidosis with or without coma. * In the presence of severe liver disease. In the presence of renal impairment or when renal function is not known and also in patients with serum creatinine levels above 1.5 mg/100 ml. * In chronic alcoholism with hepatic damage. * In patients undergoing medical or diagnostic examinations, such as intravenous pyelography or angiography which could lead to a temporary function oliguria (see Warnings). * In cases of cardiovascular collapse and in disease states associated with hypoxemia such as cardiorespiratory insufficiency, which are often associated with hyperlactacidemia. * In patients suffenng from severe dehydration. * During stress conditions, such as severe infections, trauma or surgery and the recovery phase thereafter. * Known sensitivity or allergy to the drug. * In patients with a history of lactic acidosis irrespective of the precipitating factors. WARNINGS: The use of Glucophage will not prevent the development of complications peculiar to diabetes mellitus. Use of Glucophage must be considered as treatment in addition to proper dietary regimen and not as a substitute for diet. Glucophage should be immediately discontinued in the presence of acidosis. Lactic acidosis can be precipitated during therapy with biguanides and some cases have been reported with metformin. In all the reported cases, patients were suffenng either from s.nificant functional or organic renal insufficiency or from hepatic failure. In isolated instances, hepatic necrosis, acute pancreatitis, drug overdose, intravenous pyelography and aortography leading to oliguriawere suspected as contnbutoryfactors (see Adverse Reactions). The risk of lactic acidosis increases with the degree of renal dysfunction, impairment of creatinine clearance and age of the patient. Patients with serum creatinine above the upper limit of the normal range should not receive metformin. In patients undergoing intravenous pyelography or angiography, Glucophage should be discontinued 2 days prior to the procedure and therapy may be reinstituted afterthe renal function has been re-evaluated. Discontinue Glucophage 2 days before a surgical intervention. Therapy may be reinstituted following the operation after the renal function has been re-evaluated. Patients should be warned against using alcohol in excess while on metformin therapy. Alcohol in a diabetic subject may cause an elevation of blood lactate. PRECAUTIONS: Patient aelection and follow-up: Careful selection of patients is important. Ills imperative that there be rigid attention to diet, and careful adjustment of dosage. Drug interactions with metformin: Certain drugs may potentiate the effect of Glucophage, particulatfy sulfonylures type of drugs used in the treatment of diabetes. The simultaneous administration of these two types of drugs could produce a hypoglycemic reaction, especially if they are given in patients aireadyreceiving other drugs which, themselves, can potentiate the effect of the sulfonylureas. These drugs can be: long-acting sulfonamides, tuberculostatics, phenylbutazone, clot ibrate, monoamine oxidase inhibitors, salicylates, probenecid and propranolol. Other drugs tend to produce hyperglycemia and may lead to a loss of blood sugar control. These include diuretics (thiazides, furosemide), corticosteroids, oral contraceptives (ostrogen plus progestogen) and nicotinic acid in pharmacologic doses. ADVERSE REACTIONS: The mostfrequentiy reported adverse reactions are: metallic taste in the mouth, epigastric discomfort, nausea and vomiting; rarely: diarrhea and anorexia. Most of these reactions are transient and can be brought under control by reducing the dosage or by discontinuing therapy. DOSAGE AND ADMINISTRATION: In diabetic patients, individual determination of the minimum dose that will lower the blood glucose adequately should be made. The usual starting dose is one tablet (0.5 g) three times a day. Maximal dose should notexceed 2.5 grams (5 tablets) a day. To minimize gastric intolerance such as nausea and vomiting, Glucophage should be taken with food whenever possible. AVAILABILITY: Tablets (500 mg) white, round, convex, scored, imprinted NORDIC. Botfies of 100 and 500 tablets.
PHARMACEUTICALS LTD Laval,Que. Canada.
spective of its weaknesses and potential negative impacts." Dominion and several other diagnostics concerns submitted lengthy briefs to the committee in an effort to prevent the Red Cross from entering their territory. But because the SNC study was kept confidential until all briefs had been lodged, they had no way of knowing that the Red Cross had been advised by the consultants to stay away from diagnostics manufacturing for the time being. Connaught, after submitting two lengthy counter-briefs and attending the 1-day public hearing earlier this year, continues to feel concern. "We have felt from the beginning we have been on the defensive," says Mr. Davies. "When we tried to introduce the socioeconomic benefits question, it was essentially thrown out. They didn't seem to want to know the other side of the argument." Other views
Within the health care field, support has varied: the Canadian Hospital Association, for example, supports the Red Cross proposal to build a fractionation plant while the Canadian Medical Association advised the committee it had not changed its policy since its investigation of criticisms concerning Connaught's operations. In 1977, the CMA committee concluded that: "Connaught should continue in association with the Red Cross to provide blood products for Canada; collaboration with the Red Cross should be improved. Improvements must be made to the production facilities and procedure in the blood products division at Connaught."
The Red Cross's desire to take over fractionation is understandable. From an organizational standpoint, plasma processing is the only step it is missing in its role as Canada's blood collector and blood supplier. Whether it is wrong to sell excess blood fractions, or use human blood products to defray overhead contributing to the production of biologicals produced from animal products, is a matter for personal conjecture. Certainly, at the government level, the desirability of "gratuity of blood products" has been clearly enunciated. Connaught's position is also understandable. The corporation has estimated it would have to increase the price of other Connaught products by $2.2 million a year, it would face closing down its $1.1 million plant and laying off 50 staff. The loss of fractionation, one of the few areas where Connaught is making money, would represent a serious blow to the corporation, a loss that could be reflected in the price paid for future federal and provincial vaccination programs as well as the cost of insulin to Canadian diabetics. It is difficult to envision how the fractionation committee can reach an informed decision based on the widely conflicting information it has received from both the Red Cross and Connaught. And because of its relationship with the two organizations, it is also hard for any decision to be free of the taint of politics. And perhaps most important, it is unlikely that a decision either way will address itself to the larger problem of national self-sufficiency in blood products, a goal still far in the future.E
Health records confidentiality The rights of the individual and society ANNE GILMORE
Scene: an airport in Canada. A mentally disturbed gunman is holding hostage 150 innocent people. The police call in to a psychiatric hospital for his medical record. Does the hospital give it? The law says no. This was the dilemma that Mr. Justice Horace Krever posed to 300plus delegates to the annual convention of the Canadian Health Records
Dyazide® To lower blood pressure and conserve potassium. Before prescribing, see complete prescribing information in CPS. The following is a brief summary. ADULT DOSAGE: Hypertension: Starting dosage is one tablet twice daily after meals. Dosage can be subsequently increased or decreased according to patient's need. If two or more tablets per day are needed, they should be given in divided doses. Edema: Starting dosage is one tablet twice daity after meals. When dry weight is reached, the patient may be maintained on one tablet daily. Masimum dosage four tablets daily. INDICATIONS: Mild to moderate hypertension in patients who have developed hypokalemia and in patients in whom potassium depletion is considered especially dangerous (e.g. digitalized patients). Medical opinion is not unanimous regarding the incidence and/orclinical significance of hypokalemia occurring among hypertensive patients treated with thiazide-like diuretics alone, and concerning the use of potassium-sparing combinations as routine therapy in hypertension. Edema of congestive heart failure, cirrhosis, nephrotic syndrome, steroid-induced edema and idiopathic edema. Dyazide is useful in edematous patients whose response to other diuretics is inadequate. CONTRAINDICATIONS: Progressive renal dysfunction (including increasing oliguria and azotemia) or increasing hepatic dysfunction. Hypersensitivity. Elevated serum potassium. Nursing mothers. WARNINGS: Do not use potassium supplementation or other potassium-conserving agents with Dyazide since hyperkalemia may result. Hyperkalemia (>5.4 mEq/t) has been reported ranging in incidence from 40/a in patients less than 60 years of ageto 2./. in patients 60 and older, with an overall incidence of less than 8%. Rare cases have been associated with cardiac irregularities. Make periodic serum potassium determinations, particularly in the elderly, in diabetics, and in suspected or confirmed renal insufficiency. If hyperkalemia develops, withdraw Dyazide and substitute a thiazide atone. Hypokalemia is less common than with thiazides alone, but if it occurs it may precipitate digitalis intoxication. PRECAUTIONS: Check laboratory data (e.g. BUN, serum electrolytes) and ECGs periodically, especially in the elderly, in diabetics, in renal insufficiency, and in those who have developed hyper kalemia on Dyazide previously. Electrolyte imbalance may occur, especiatly where salt-restricted diets or prolonged high-dose therapy is used. Observe acutely ill cirrhotic patients for early signs of impending coma. Reversible nitrogen retention may be seen. Observe patients regularly for blood dyscrasias, liver damage or other idiosyncratic reactions; perform appropriate laboratory studies as required. Sensitivity reactions may occur, particularly in patients with history of allergy or bronchial asthma. Periodic blood studies are recommended in cirrhotics with splenomegaly. Adjust dosage of other antihypertensive agents given concomitantly. Antihypertensive effects of Dyazide may be enhanced in the post-sympathectomy patient. Hyperglycemia and glycosuria may occur. Insulin requirement may be altered in diabetics. Hyperuricemia and gout may occur. Thiazides have been reported to exacerbate or activate systemic lupus erythematosus. Pathological changes in the parathyroid glands have been reported with prolonged thiazide therapy. Triamterene may cause a decreasing alkali reserve, with the possibility of metabolic acidosis. Serum transaminase elevations sometimes occur with Dyazide. Thiazides can decrease arterial responsiveness to norepinephrine and increase tubocurarines paralyzing effect; exercise caution in patients undergoing surgery. Thiazides cross the placental barrier and appear in breast milk: this may result in fetal or neonatal hyperbilirubinemia, thrombocytopenia, altered carbohydrate metabolism arid possible other adverse reactions that have occurred in the adult. Use in pregnancy only when deemed necessary for the patients welfare. ADVERSE REACTIONS: The following adverse reactions have been associated with the use of thiazide diuretics or triamterene: Gastrointestinal: dry mouth, anorexia, gastric irritation, nausea, vomiting, diarrhea, constipation, jaundice (intra-hepatic cholestatic) pancreatitis, sialadenitis. Nausea can usually be prevented by giving the drug after meals. It should be noted that symptoms of nausea and vomiting can also be indicative of electrolyte imbalance (See Precautions). Central nervous system: dizziness, vertigo, paresthesias, headache, xanthopsia. Dermatologic- Hypersensitivity: fever, purpura, anaphylasis, photosensitivity, rash, urticaria, necrotizing angiitis. Hematologic: leukopenia, thrombocytopenia, agranulocytosis, aplastic anemia. Cardiovascular: orthostatic hypotension may occur and may be potentiated by alcohol, barbiturates, or narcotics. Electrolyte imbalance (See Precautions). Miscellaneous: hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness, transient blurred vision. SUPPLY: Scored light orange compressed tablets monogrammed SKF E93 in bottles of 100, 500, 1,OOOand 2,500 DIN 181528
Association in Ottawa last month. "What do you do?" asked Krever. "Is society willing to risk the lives of 150 people on a hijacked airplane to hydrochlorothtaztde protect the hijacker's right to privacy?" He paused, then said, "I don't makes sense 50 mg triamterene know the answer to that question." Judge Krever, chairman of the Ontario royal commission into the con. Smith Kline & French Canada Ltd. fidentiality of health records, was S Montreal,Quebec H4M
1096 CMA JOURNAL/NOVEMBER 4, 1978/VOL. 119