COVER

The new medicine’s grave risks

Linda McQuaig September 6 1982
COVER

The new medicine’s grave risks

Linda McQuaig September 6 1982

The new medicine’s grave risks

COVER

Linda McQuaig

Beneath a high-powered microscope, the patient lies motion-

less on an operating table, a patch of his brain exposed.

A piece of his skull lies in a jar on a table nearby. Dr.

John S. Peerless, chairman of neurosurgery at the University of Western Ontario, stares through the lenses while he tries to attach two arteries, using a device smaller than a strand of human hair. The operation—a cerebral bypass, modelled after the widely used coronary bypass—is on the verge of becoming an accepted medical procedure.

Already 1,200 a year are performed in the United States and 150 in Canada in the hope of reducing the risk of strokes. Yet for all the brilliant technological and human precision required, there is not a scrap of hard evidence that the operation actually works.

The cerebral bypass is just one example of how, in the past few decades, medicine has undergone dramatic changes as electronic, computer and nuclear technologies have replaced the limited range of remedies in

range the doctor’s bag. From their traditional role as healers and soothers, doctors have been transformed into sophisticated technocrats with arsenals of machinery to analyse, diagnose and sustain the human body. Advancing into uncharted waters, doctors and medical scientists have captivated the press and the public with miraculous new gadgets and techniques—from test-tube conception to promises of a mechanical heart that will do everything short of falling in love.

In reality, the flashing lights of the new gadgets may have blinded many to the fact that the benefits of much of modern medical technology remain unproven. Clothed in the mantle of science, a good deal of medical procedure has become accepted practice more through the faith of its practitioners than through scientific assessment, with some doctors being openly hostile to attempts at measurement. Austra-

lian physician Richard Taylor, author of the 1979 book Medicine Out of Control: Anatomy of a Malignant Technology, has even charged that much of modern practice is “science-fiction medicine.”

Taylor’s attack may seem jarring to a society that is as dazzled by the advances of modern medicine as it is by space shuttles and microchips. Indeed, there have been breakthroughs in the past century that have dramatically improved the ability of doctors to care for the sick. Appendicitis used to claim the lives of one-third of those who developed it before doctors figured out how to remove the appendix safely. Similarly, the development of chemotherapy has allowed physicians to cure more than half of the victims of a once fatal form of childhood leukemia. Furthermore, certain technological advances—such as dialysis machines— have definitely saved lives, and new di-

agnostic equipment has allowed life-threatening conditions to be detected and treated earlier.

But perhaps because of these well-known successes, society has embraced nearly all medical innovation approvingly, without any real attempt to evaluate it and control its application. Doctors, for the most part, have been given a free rein to regulate their own profession and its tools, and, not surprisingly, their assessment of both has been generally favorable. One of the few organizations that has attempted to take a critical look at medical technology is the Office of Technology Assessment (OTA), an advisory group set up by the U.S. Congress in 1972. Challenging the popular orthodoxy of medical technology, the OTA has dared to suggest that the emperor, if he is wearing any clothes at all, is at best scantily clad. In a 1978 report the OTA put forward the startling assessment that only 10 to 20 per cent of present medical procedures have been proven to be beneficial. “The surprising thing,” says OTA As-

sistant Director Dr. David

Banta, “is that nobody has quarrelled with those figures.”

The question of technology’s benefits becomes all the more charged when its costs are brought into the equation. While provincial health care budgets are being badly squeezed in the current recession, the technology explosion continues, producing ever more sophisticated and costly devices. This has meant a greater concentration of resources on fewer patients. Anne Toupin, vice-president of patient services at Burnaby General Hospital in British Columbia, says, “A machine may seem like a neat piece of equipment, but it may only benefit five per cent of the patient population.”

Still, the machines proliferate. Some of the advances have been truly astonishing from a technological point of view. Highly sophisticated Computer Tomography (CT) scanners can detect tumors and abnormal tissue formations

by sending X-rays through a patient’s body. And Positron Emission Tomography (PET) creates a visual computercompiled account of the circulatory system. Technology has also made dramatic strides in developing elaborate life-support systems and lab tests that screen patients’ body fluids for literally thousands of diseases—including abnormalities that have yet to be labelled.

Surprisingly, however, there has been little effort made to control this expanding market. Out of some 5,000 classes of medical devices sold in Canada, a mere five are subject to premarket government review and those only because public pressure forced the government to act. As a result, while tampons, lUDs, heart pacemakers and two kinds of eye lenses must be approved in Canada, there are no regulations governing heart valves, dialysis machines and brain implants. “You can make any

device in your basement and sell it on the market,” says Dr. Ajit Dasgupta, director of the federal government’s Bureau of Medical Devices, although he points out that the bureau plans to introduce regulations for body implants. The general lack of regulation has been a boon to manufacturers and means potentially higher profit margins in the sale of medical devices than in the sale of drugs, which are subject to government review. It has also meant that some medical equipment sold in Canada is inadequate. “Most of them [the devices] don’t do what they say,” comments Dasgupta. For example, a certain blood-test kit used to measure glucose levels at home was found to give false readings that, if acted upon, could send a diabetic into a coma. (The manufacturers recently corrected the malfunction.)

Canada is a major user of medical technology, but it imports more than 80

per cent of its devices—including many from underdeveloped countries. These devices are not subject to review by Canadian authorities, and few Canadian hospitals have biochemical engineers to assess new equipment. The result is that a lot of defective or unevaluated devices end up in Canadian hospitals, according to Dasgupta. The Bureau of Medical Devices sent out 48 alert letters during the past three years warning hospitals about dangerous equipment and received some 400 complaints last year, which Dasgupta figures represents a small proportion of the actual problems. Some doctors are not even aware that the devices they implant into patients are being scrutinized only by the companies that sell them.

Indeed, last week the Department of Health and Welfare Canada issued a§ bulletin warning doctors that an esti-1 mated 1,000 heart-valve implant pa-1 tients may be at risk from defective

valve devices. In the past three years Canadian authorities have notified doctors to watch patients carefully who receive certain valve models that, it was later discovered, disintegrate inside the body. In some cases particles of cloth from the valve break off, float through the bloodstream and end up in the heart, the liver or even the brain. This latest medical alert was prompted by the death of a 49-year-old Regina clergyman last May. One of the tiny balls that control the flow of blood through the device broke off and the valve stopped functioning, killing the man. Says Pierre Blais, a biochemist in the Medical Devices Bureau: “When that goes, the patient has about one

minute to live.”

While most attention paid to medical technology has focused on the more spectacular devices, many of the less obvious changes technology has brought about may be more worrisome, according to physicist David Johnson, chief of the research and standards division of the Bureau of Medical Devices.

Johnson points to the example of the infusion pump, a highly complex piece of technology used in hospitals to control the flow of fluids intravenously. Traditionally, intravenous flow was controlled simply by the gravitational pull created by placing fluids in bottles above the patient. Now, infusion pumps equipped with

computers and micro-

processors can more accurately monitor and control the flow. But, unlike the old intravenous system, which simply stopped operating when the fluid ran out, the computerized ones can start pumping air into the bloodstream when the fluid is gone—a phenomenon that has led to a number of deaths in Canadian hospitals.

Even when technology clearly does work, its exorbitant costs raise other problems. By making possible so many new procedures, technology can create an almost unlimited medical bill. Canada, with its centralized public-funding system, has kept health care spending to about seven per cent of the GNP. But in keeping overall costs down, provincial governments are increasingly faced with the prospect of cutting hospital staff or services in order to cope with the rising technology bill.

CT scanners alone cost $1 million to buy, $200,000 to install and $80,000 a year to maintain. And already there are 45 CT scanners in Canada. But while the scanners have proven to be highly effective in identifying certain kinds of problems, such as tumors, debate rages over whether they are being overused. Some critics charge that doctors are now using scanners as a first diagnostic tool for patients with such symptoms as recurring headaches. Dr. William Dorsett, a special projects analyst with the Saskatchewan government’s Hospital Services Plan, also points out that such devices as CT scanners have honed modern medicine’s diagnostic abilities in many areas well beyond its ability to cure. Asks Dorsett: “What benefit is it to the patient to be able to get ever more

precise information about his disease without being able to do anything about it?”

Technology has also created a costly boom in lab testing, with little assessment of the benefits. There are now more than a billion lab tests done in Canada annually—800 million more per year than were carried out a decade ago. Yet one 1971 Vancouver study by internist Christopher Korvin suggests that much of the testing that goes on may be unnecessary. Korvin evaluated the use of an autoanalyser, a blood-testing machine that was heavily promoted by its manufacturer. The machine was used to test the blood of all patients admitted to St. Paul’s Hospital, but Korvin found that only one out of 1,000 patients tested derived potential benefit from such screening. “We found that this was an extremely low-yield procedure

for a very considerable expense,” says Korvin.

Vancouver health economist Robert Evans points out that, as more and more conditions become diagnosable through testing, a case can be made for screening everyone for a wide variety of possible ailments. “The costs are literally limitless,” he says. One 1975 study published in The New England Journal of Medicine discovered just how limitless when it examined the costs of the American Cancer Society’s recommendation that a test for cancer of the colon be done six times to make sure all possible cases are detected. If applied to the general population, the study found, the cost of diagnosing colon cancer on the sixth test would turn out to be an astonishing $47 million per

case. Johnson, from Canada’s Bureau of Medical Devices, also points to a further consideration: the test occasionally gives a false reading. When people are told they have cancer, he says, “they have been known to commit suicide.”

Perhaps the most devastating potential costs of technology lie in the expectations it has unleashed. Traditionally, doctors accepted the notion that there were limits to what they could do once an organ had deteriorated beyond a certain stage. But now medicine is more aggressive, as doctors try to replace failing or defective human parts with plastic or metal substitutes. This aggressive approach

produced some

clear-cut benefits. About 3,000 Canadians who would otherwise have died due to malfunctioning kidneys are now kept alive by having a dialysis machine function as their kidneys—at a cost of roughly $25,000 per patient.

But artificial kidney devices are only the beginning. Scientists are now working on an artificial pancreas, an artificial lung and even an artificial heart. Dr. Dimitrios Oreopoulos, a nephrologist at Toronto Western Hospital, points out that if these prostheses were made available to everyone who needs them, the costs would be enormous. “If the artificial heart costs $50,000 per operation, what if there turn out to be thousands of people willing to try it?”

One of the difficulties in assessing technology is deciding who will make the assessment. Indeed, it may be unre-

alistic to expect doctors to be objective about the necessity and desirability of the procedures they have to offer. “You don’t go to a barber to find out if you need a haircut,” says Dr. Murray Enkin, assistant professor of obstetrics and gynecology at McMaster University in Hamilton, Ont. Often, doctors become convinced that a procedure works simply from their clinical experience. “Some clinicians would die on behalf of their faith that an operation works,” says McMaster epidemiologist Peter Tugwell. “But clinical findings have been proven wrong so many times.” These mistakes can have serious implications, however, since doctors play a key role in determining which technologies will be developed. The potential problems can perhaps best be seen in the case of a gastric freezing procedure. In 1961 Minnesota surgeon Owen Wagensteen developed a procedure for treating duodenal ulcers by circulating low-temperature alcohol through a tube that ran in and out of the patient’s stomach via his nose. Wagensteen teamed up with Swenko, a refrigerator company, to develop an $1,800 machine that would refrigerate and pump the alcohol. Doctors who experimented with it quickly became enthusiastic, and glowing accounts soon appeared in medical journals and the popular press. Two years later, however, investigators began to discover that the procedure was not effective—and that it posed substantial risks to patients. By 1966

Wagensteen’s gastric freezing procedure was discontinued—after 2,500 machines had been sold and more than 25,000 patients had been treated.

Many physicians have also showed little skepticism about adopting risky operations for heart disease, the leading killer in North America. Over the past half-century, five different heart operations were developed and keenly promoted by doctors, only to be eventually abandoned as useless. Then, in the early ’70s, surgeons developed a procedure to bypass a blocked artery. They removed a piece of artery from the leg and attached it to the outside of the blocked passage, thus creating a bridge for the blood to flow through. Despite the costs of coronary bypasses—about $20,000 in Canada—and the risks of such major surgery, the operation became quickly and widely accepted before its benefits were measured. Currently, an estimated 100,000 bypasses are performed each year in the United States, 5,000 in Canada. Recent studies indicate that the procedure is beneficial in reducing pain from angina, although the pain sometimes reappears. But original expectations that it would prolong life have not proven to be true, except in about 15 to 20 per cent of cases that can be diagnosed prior to surgery. In 1977 there were 369 bypasses performed in the United States for every one million people, as compared to 20 bypasses per million in Sweden, yet both countries had roughly the same death rate from heart disease. OTA’s Banta estimates that about half the bypasses in the

United States are performed prema-g turely, when there is no indication that? the patient is going to benefit. “I’m con-£ vinced that that form of surgery is 2 grossly overused,” he says. “There is a| large number of surgeons who keep5 themselves busy doing it.” 8

The keenness of doctors to adopt newïï procedures has led to a bizarre ethic in the medical community—a procedure is considered acceptable until it is proven to be unacceptable. Dr. Sydney Segal, head of a committee that studies medical ethics at the University of British Columbia, criticizes that tendency. He says that before a procedure becomes accepted it should be tested through the use of random trials in which patients who are aware that they are participating in an experiment are divided into two groups; one group is given the procedure, the other is not. Instead, however, procedures—such as the coronary bypass—often become popular without that kind of assessment, and the onus is then on critics to prove that they are not beneficial. Such attempts to challenge accepted procedures have run into difficulties because doctors asked to participate in the control trials sometimes refuse, arguing that they do not want to deny their patients any possible benefits. Furthermore, according to the OTA, some heart surgeons refused to participate in the coronary bypass trials, then turned around and attacked the results

on the grounds that some of the best surgeons had not participated in them.

Peerless, from the University of Western Ontario, is attempting to prevent the cerebral bypass from becoming as accepted as its popular cousin before its benefits are established. He points out that the simple taking of ASA, which is found in Aspirin, for example, has successfully reduced a male patient’s chance of a stroke—by about 50 per cent. Unless the cerebral bypass further reduces that likelihood, its use would be seriously questioned. With that in mind, Peerless and others set up an international study in which candidates for the surgery were randomly divided—with their consent—between simple ASA treatment and ASA plus surgery. While Peerless will not reveal any preliminary findings, there is some indication that the operation has not, so far, proven to be much more effective than simple ASA treatment. An independent committee that monitors the results is empowered to call off the study at any point if one form of treatment appears to be producing significantly better results. Yet, five years into the study, the committee has not called a halt.

The arrival of new technology sometimes leads doctors to abandon simple procedures that may have been less convenient but safer, says Johnson. In put-

ting a patient under anesthetic, doctors have traditionally used perhaps the crudest and simplest procedure of all to check that the patient is getting enough oxygen—they watch to see if his face turns blue.Yet when technologically sophisticated oxygen monitors became widely used two years ago, doctors in a few cases relied on the machine alone and thus failed to double-check for problem signs in the patient—resulting in

several deaths.

Technology’s ever increasing ability to diagnose problems can also lead to more intervention by doctors. Doctors used to monitor the heartbeat of a fetus during labor by pressing a stethoscope to the mother’s abdomen. But in the past decade that simple technique has been replaced in many hospitals by electronic fetal monitors, which involve attaching a belt around the mother or electrodes to

the head of the fetus through the mother’s vagina. However, monitors can falsely indicate fetal distress, leading doctors to perform caesarean surgery. In the past 10 years caesareans in Ontario increased to 18 per cent from six per cent. Recent studies, conducted well after the monitors achieved their popularity, have failed to substantiate their usefulness, according to Enkin. Comments Dr. David Naylor, a Canadian doctor studying medical ethics at Oxford: “Surely common sense tells us the uterus was not constructed to suffocate the fetus.”

Technological intervention can pose high risks to patients. Taylor, from Australia, suggests that some patients may experience considerable stress in coronary care units, where they are hooked up to numerous machines, have tubes running in and out of their bodies and bright lights beaming into their eyes 24 hours a day. “It is just conceivable that the whole medical technology of coronary care units designed to prevent deaths may actually cause them,” he says.

Although medical technology has often succeeded in sustaining life, it has not always been as successful in improving the quality of life. Machines can now support body functions, allowing elderly or chronically ill patients to live longer, often in miserable circum-

stances, strapped to monitors and undergoing unpleasant treatments. But the question of quality of life has perhaps been raised most poignantly in relation to the complex technology that allows doctors to keep alive premature, underweight infants who, 20 years ago, would have died. Such babies have a higher risk of handicap, including cerebral palsy, brain damage, blindness and mental retardation. A massive study by the OTA found that in 1978 intensive care helped save more than 16,000 premature infants who would otherwise have died. But among those saved were 350 severely handicapped babies. Asks obstetrician Enkin: “How many blind babies justify saving one life?”

In aggressively trying to sustain life, doctors are now experimenting with procedures that, at least in their developmental stages, raise some doubts as to their necessity. Most ambitious—and gruesome, perhaps—is the operation for an artificial heart, a plastic device that pumps blood through a pneumatic mechanism hooked up to a console outside the body. The device is used to keep the patient alive long enough for a heart donor to be found so doctors can perform a transplant—a highly risky procedure in itself. So far, three patients in the United States have had such devices implanted. Two died. The most recent to receive the device “lived” for 55 hours—

semiconscious, hooked up to a console, with his rib cage open—but died of complications after receiving a human heart.

For all that, the operation has won its practitioners considerable fame. A cover story in Life magazine last fall referred to pioneer surgeon Denton Cooley as “God,” as well as describing him as a “blond, movie-star handsome hero of medicine . . . with the instincts of a champion.” Life also described the competition between the leading heart surgeons to be the first to perfect the procedure as well as how frustrated they become when others appear to be pulling ahead. Cooley is leading, so far, with a score of two, but wDr. Willem Kolff, who yfirst implanted an artificial heart in a dog in 1957 |and now heads up an artificial organ program at gthe University of Utah, ¿still considers himself in

the race. Kolff dreams of creating a heart that will keep a patient alive indefinitely and is not fazed by the fact that, for now at least, a patient must remain strapped to a machine. He counters that this still leaves the patient better off than many paraplegics and quadraplegics.

And there remains the question of costs. The price of the artificial heart operation runs close to $50,000, and an estimated $70 million has been spent on developing the device. This leaves less money to solve the more basic medical problems that affect a far larger number of patients. For instance, plastics used for hospital blood-storage bags, catheters and intravenous tubing—devices used on just about all hospitalized patients—contain potentially harmful chemicals, including a plastic softener called DEHP.

Last month the Bureau of Medical Devices warned hospitals that these chemicals end up in the bloodstream. (In fact, U.S. food manufacturers voluntarily removed packaging containing DEHP from

market.) Yet, despite mounting evidence in medical literature about the problems with these plastics, manufacturers are actually increasing their use in Canada. The two largest producers— Abbott Laboratories and Baxter-Travenol—have recently notified hospitals across the country that previously available glass storage bottles will be replaced by plastic bags. Abbott Director of Manufacturing Jim Dunnsmuir and Baxter-Travenol National Marketing Manager Richard Doherty both say the plastics are safe. But Vancouver pediatrician Segal—and many of his colleagues—questions the safety. Ironically, Abbott’s conversion into plastics, which will mean increased use of the controversial plastic softener in Canada, is being carried out with the help of a grant from the federal government.

Concentration of funding on technology takes money away from programs aimed at prevention. Asks Enkin: “Are we better off spending $20,000 on a fetal

monitor or on hiring an extra public health nurse?” Dr. Trevor Hancock, of Toronto’s public health department, points out that the most dramatic reduction in the incidence of communicable diseases actually came about before the introduction of immunization and was largely due to improved sanitation, nutrition and living conditions. He argues that 20th-century living is now plagued with a different set of environmental hazards, but research funding is heavily concentrated on last-ditch medical intervention techniques. Canada’s Medical Research Council, which primarily channels research funds into technology, distributed $110 million in grants last year, while the National Health Research and Development Program had only $14 million to dispense toward solving public health problems.

The issue can perhaps be seen most dramatically in the debate about how to deal with the problem of premature

infants. Dr. James Roxburgh of the Medical Research Council says the council plans to increase funding for research into neonatal intensive care units—a highly technological approach to the problem. On the other hand, a Montreal project found that when pregnant women were given a daily litre of milk, an egg and an orange, they had fewer premature infants, thus reducing the major cause of handicaps. Furthermore, the cost of providing a few dairy products and fruit pale against the cost of neonatal intensive care. One 1978 study, published in the U.S. medical journal Pediatrics, found that the cost of saving a child weighing 1,000 gm or less through intensive care can exceed $40,000.

The days of limitless funding for health care clearly seem to be numbered, and with greater competition for what is left of the health pie inevitably will come calls for a harder look at the ^benefits of various technological advances. The ^decisions are particularly poignant because 5they involve such high stakes—nothing less

than human life. B.C.

health economist Evans poses the question as to whether or not $100,000 would be wisely spent on a screening procedure that found only one case of operable cancer. To the family of the victim, whose life might be saved by the early diagnosis, the procedure would be worth every penny. But, he asks, what about the families of 10 or 100 or 1,000 victims of other ailments who might have been saved had that money been spent on some other health program?

Until now there has been surprisingly little attempt to make these kinds of calculations, leaving the decisions up to individual doctors—or often to the marketplace. Cautions Evans: “The market has never been a good way to answer the question of who should live and who should die.” It is a question that, up until now, few have even been willing to

address.__

With Jane Mingay and Lori d 'Agincourt in Toronto.