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Answer4AChapter14.docxChapter 14
The medical-industrial complex is a large and growing network of private and semi-public corporations engaged in the business of providing medical care and medical care products, supplies, and services for a profit. Included in the medical-industrial complex are, among other things, hospitals and nursing homes, home-care services, diagnostic services, including expensive CT scanners and MRIs, hemodialysis supplies and equipment, pharmaceutical companies, medical tools and technology, and even laundry and food-packaging companies that supply hospitals and other health-care organizations. This complex is global and is a part of a new world order (Usher & Skinner, 2012) under neo-liberalism. The pharmaceutical industry, an important component of the medical-industrial complex, will be discussed in detail in this chapter.
When do you decide to go to the pharmacy for over-the-counter medication? Some of you try to become aware of the side effects of various over-the-counter and other medications. Some of you ask the doctor about long-term effects. Some of you take your prescribed medication exactly as directed—over the length of time suggested and at the prescribed intervals. Most of us assume that all the drugs available in Canada have been adequately tested and are safe. However, this assumption is not true (Canadian Foundation for Health Care Improvement, 2010). Many of you will have heard of thalidomide, Vioxx, Ritalin, Diane-35, or DES. Do you know some of the devastating results of their use? You may have considered the question of the extent to which the pharmaceutical, medical device, and biotechnology companies are reliant on and motivated by making a profit as compared to serving those suffering sickness and pain. Have you ever thought about the effects of pharmaceuticals on the environment? They may be excreted from our bodies (our bodies only absorb a portion of the drugs we routinely administer to ourselves) or flushed as tablets or syrups down a drain when we no longer think they are of use. After a person dies, as the body decomposes, the drugs (or chemicals) leech from the body and are absorbed by the earth. These are among the issues that will be addressed in this chapter.
Any discussion of the pharmaceutical industry and the use of drugs in contemporary Canadian society must be fairly wide-ranging because this topic involves a large number of sociological issues. The drug industry is a major actor in Canadian medical care, and its share of health spending in Canada grew from 9.8 per cent in 1983 to 12.6 per cent in 1990. In 2019, according to the Canadian Institute for Health Information, 15.3 per cent of the total Canadian health-care budget was spent on pharmaceuticals (CIHI, 2019; see Figure 14.1). Prescribed drugs make up the largest component at 84.6 per cent and over-the-counter drugs comprise 15.4 per cent. There is evidence of the flattening of this upward trend line because several “blockbuster” drugs used to treat the high-prevalence conditions of hypertension and high cholesterol have moved off patent and thus are now available in the much less costly generic form. Still, drugs continue to be the second largest expenditure in the health-care system after that spent on hospitals. Although the proportion spent on physicians has been growing lately, as doctors’ salaries and numbers have both grown, it is still somewhat less than that spent on drugs. While the Canada Health Act covers all necessary hospital, physician, surgical-dental, and a portion of long-term care services, it does not include prescription drugs outside of hospital. Thirty-one per cent of prescription drug costs are covered by private insurance plans, often associated with the workplaces of Canadians, 33 per cent of costs are paid for out of pocket, and 36 per cent by government programs (for Indigenous people, older people, and those in the military). The costs to consumers who either lack drug insurance altogether or have limitations in respect to drug coverage have grown more quickly than the overall health budget. This relative cost of pharmaceuticals constitutes another element of mounting privatization in health care in Canada. The proposal for universal pharmaceutical coverage (Morgan et al., 2015) paid through taxation seems to be gaining support. According to OECD data, Canada is near the top of the OECD countries with respect to the out-of-pocket cost of pharmaceuticals (see OECD, 2018).
In the latest figures, more than 15.3 per cent of Canada’s health budget went for out-of-hospital drugs, or $1,078 per person. Slightly less was spent on physicians—$1,064 per person or 15.1 per cent (CIHI, 2019). Hospital expenditures amounted to 26.6 per cent or $1,880 per person, which included in-hospital pharmaceutical spending. The amount spent reflects the growing reliance on drugs for treatment and for prevention. It also represents the adoption of new and thus more expensive drugs, according to CIHIs National Health Expenditure Trends. Greater spending includes an increase in cost for newer anti-psychotics and the uptake of prevalent anti-anxiety and anti-depression drugs. Drug cost increases constitute another element of mounting privatization in health care in Canada, and, needless to say, drug coverage varies by socio-economic and socio-demographic groups in Canada.
A significant cause of the increase in drug expenditures is the development of new and often me-too drugs. In the last few years these have been drugs to treat hepatitis C and macular degeneration (CIHI, 2018). Drugs designed to mitigate the inflammation of diseases such as arthritis and Crohn’s disease reflected the highest proportion of expenditure for the sixth year in a row. These are newer, more expensive drugs marketed and used for the same conditions in the place of older, less expensive pharmaceuticals (Canadian Health Coalition, 2006). The new drugs may or may not be better than the older versions and they may or may not be safe (Canadian Foundation for Health Care Improvement, 2013).
The increase in drug expenditures is also due to aggressive advertising both to physicians and to consumers. This advertising is global and highly influential, especially in the presence of the World Wide Web (Usher & Skinner, 2012); plus, in Canada, televised drug commercials from American networks and cable channels have become ubiquitous. Drug “scandals” are frequent. Hormone replacement therapy (HRT) was prescribed to millions of women for a number of years. Then, epidemiological research demonstrated that it caused an increase in strokes, heart attacks, breast cancer, blood clots, and gallstones. It is now to be used only in exceptional circumstances (Canadian Health Coalition, 2006). Another prescription drug for women, Yasmin or YAZ is suspected to have caused at least 23 deaths in Canadian women ( CBC News, 2013). Possibly the most widely prescribed drug class in Canada is a cholesterol-lowering statin called Lipitor for which there were many millions of prescriptions per year ( CBC News, 2013). This drug is intended for basically healthy people to prevent high cholesterol, despite the fact that its value as a preventive is not clear and is hotly debated. In addition, it does have side effects. About 450,000 prescriptions of Diane-35, a drug marketed for acne and sometimes used for birth control, were sold to Canadian women annually. This drug was responsible for the deaths of 11 young women and over 200 adverse reactions reported to the Toronto Star (Zlomislic & Teotonio, 2013). Diane-35 was removed from sale in France because it was considered unsafe after four girls apparently died as a result of taking it. Such a finding may point to the relative weakness of the Canadian government in the face of the pharmaceutical industry (Zlomislic & Teotonio, 2013) and the difficulties in removing a drug from the market once it has been approved.
It may be helpful to begin our discussion in this chapter with a pictorial representation of the various levels of analysis that will be considered in our explanation and description of pharmaceutical use in Canada (see Fig
At the first level the discussion will focus on how the socio-demographic characteristics of patients—age, gender, class—correlate with their legal drug-taking habits. The social characteristics of physicians, too, influence drug prescription—such as the form of medical practice (e.g., solo as compared with group practice), the amount of continuing education, and the size of the practice.
Pharmacists and the pharmaceutical industry, of course, are important forces in drug use as well. Cost, availability, advertising, pharmaceutical company websites, perks and benefits offered by pharmaceutical companies, and special pricing arrangements are among the factors known to influence physicians’ decisions on what to prescribe and pharmacists’ decisions on what to stock. Drug payment schemes—whether government-controlled, those offered by private insurance, or individual payment alternatives—also affect drug use. Much of the recent sociological research on drug use in Canada has focused on the pharmaceutical industry, its organization and structure, and especially on the fact that under capitalism and global neo-liberalism it must be guided by the profit motive, which at times conflicts with the goal of promoting health. The power of the pharmaceutical industry in negotiating with the Canadian government and in determining how drugs are regulated, brought onto the market, and monitored after they are on the market must be examined, too. All of these play a role in the safety, efficacy, and side effects related to the prevalence of drug use by Canadians.
Rates of Drug Use and Patient Variables: Age, Gender, and Class
Considerable evidence suggests that drugs are frequently over-prescribed in Canada. For example, it has been estimated that about half of the anti-depressants prescribed do not work except as placebos (Smith, 2012). Today at least 14.3 per cent of children in Canada and 16.7 per cent of children in the US have been diagnosed with one mental illness or another, and if addictions are added then the number jumps to 25.6 per cent in the US (a comparable figure for Canada is not available) (Perou et al., 2013). The majority of these children are prescribed medications. Different drugs may be used together, and because many of the drugs prescribed are used “off-label” (not for the condition for which they have been approved) they are tried in the hope that they might work. Some argue that this experimenting essentially violates the human rights of children. This practice and others related to diagnosing and treating children with mental health and developmental issues have been said to contribute to “surplus suffering” (Clarke, 2013). Between 5 per cent and 23 per cent of hospital admissions result from drug-related illnesses. Approximately a third of all emergency room visits among people over 65 are due to adverse drug reactions (Budnitz et al., 2011). Inappropriate prescribing or prescribing a number of medications at one time (polypharmacy) leads to additional expense to the health system because of hospitalization resulting from drug reactions (Votova et al., 2013). Aside from children, two groups, the elderly and women, are particularly vulnerable to mis-prescribing and over-prescribing (Votova et al., 2013; Rachlis & Kushner, 1994). It is very difficult to accurately estimate the effects of mis-prescribing or over-prescribing because of the lack of systematic community-based follow-up and measurement. Nevertheless, a long history of evidence from a variety of types of studies shows that women are especially likely to be over-prescribed or mis-prescribed psychotropic drugs or sedatives (Harding, 1994; Currie, 2004). Women are also likely to become addicted at an earlier age and tend to show quicker movement to drug addiction with opioids (Unger et al., 2010), and they are more likely to be prescribed pain medications such as opioids that can become addictive. Men, on the other hand, are more likely to turn their addiction to licit opioid use to illicit street-sourced use (Gerum & Choo, 2015).
Medication errors are relatively common in Canada and can be life-threatening. Approximately 24 per cent of all adverse health events (caused by medical treatment) may be due to medication errors (CIHI, 2007, citing Baker et al., 2002). Moreover, this figure is likely to represent under-reporting. The most frequent causes of these medication errors include inappropriate prescribing, incorrect use by patients, and the lack of a follow-up monitoring system by regulatory bodies. The proportion of seniors who have been and continue to be incorrectly prescribed drugs has been such a problem that an online list regularly updates prescribed drugs that are internationally recognized to be inappropriate for seniors (the Beers list, named after Mark H. Beers, the geriatrician who first published the criteria for evaluating the safety of pharmaceuticals for aging bodies in 1991). Provincially, of four provinces with available records, the prescription errors among seniors range from 18.8 per cent in New Brunswick to 12.9 per cent in Alberta. Concerted efforts are now being made to reduce these numbers (Butt, 2010) as a part of the new focus on the reduction of all medical errors since the 1999 publication, by the Institute of Medicine Committee on Quality of Health Care in America, of To Err Is Human: Building a Safer Health Care System.
About 9 million people in the US, or 4.3 per cent of the adult population, are using prescription sleeping pills, and most of these people are white, educated women over 50, according to a survey by the Centers for Disease Control and Prevention (Chong et al., 2013). Market research has reported a tripling of the use of sleep aids from 1998 to 2007. Some have linked this rising rate of insomnia to the increasing stress of modern life, while others point to the marketing successes of the pharmaceutical industry. This incidence of medication use does not include the many over-the-counter sleep aids or those sold as health products or teas through health food stores. Moreover, because stigma is associated with sleeping pill use, these figures are probably underestimates. Sleeping medications may be especially problematic because they are addictive and can cause impaired cognition, memory, and balance. Women also are more likely to be prescribed such sleep aids for longer periods of time and they may be more likely to be prescribed for “problems in living,” such as grief and adjusting to new motherhood.
Addiction is especially acute among women over 60. Benzodiazepines are often prescribed for elderly adults with sleep or anxiety problems, for longer periods of time, and at levels that may be unsafe. Benzodiazepines are especially associated with falls and hip fractures, motor vehicle accidents, accidental poisoning, hospitalization for depression, and other psychiatric problems resulting from their chronic use (CIHI, 2010). Moreover, the incidence of multiple drug use, including sleeping pills and other “hypnotics” among women and the elderly (who are more likely female), is well substantiated in the literature. In 2005 a national survey of medication use found that almost all seniors (97 per cent) living in long-term care institutions had taken prescription medications in the past two days, as had 76 per cent of those living in private households (Ramage-Morin, 2009), as compared to 14 per cent of all Canadians. Further, more than half (53 per cent) of those in institutions and 13.5 per cent in private households reported taking multiple medications. In Canada, 39 per cent of people in long-term care are prescribed an anti-psychotic (Acosta et al., 2017). At times they may be effective with the delirium that sometimes accompanies dementia but they have serious side effects, too, including strokes, kidney failure, and heart disease, and may lead to earlier mortality (Elmi et al., 2015). Older people in the community generally do not need these drugs, yet those in long-term care institutions apparently do, which may raise serious questions about over-medicating in institutions and possibly other institutional practices.
Multiple drug use increases as Canadians age. One-quarter of all potentially inappropriate drug combinations results from overlapping and similar prescriptions prescribed by two doctors for one patient. There are many potential sources of problems in drug use, especially if a person is at home alone and has been prescribed more than one medication. Table 14.1 outlines inappropriate drug use and inappropriate prescribing. You may be able to add to this list of potential problems with some that you are aware of. I, for example, remember talking with a student a while ago who had received anti-depressants from the health services at the university. She mentioned that she just took them a few at a time when she was depressed. This was despite the fact that they were to be taken daily and that the level necessary for an effective dose level was not usually reached until a person had taken them for about one month. What makes this story all the more telling is that this was a bright, relatively well-educated, and healthy young woman who was taking a potentially dangerous drug casually and on her own whim.
Social as well as medical explanations contribute to our understanding of drug use—including the more and the less dangerous of these sleeping pills, tranquilizers, pain medications, heart and blood pressure medications, stomach remedies, and laxatives. Opioid drug use is a particular case in point. It is often prescribed first for pain relief in cases of intractable and serious pain. Often, however, these drugs become addictive and people may move into an addiction that can only be satisfied by the non-medical use of such drugs. The non-medical (street) use of opioid analgesics is considered an epidemic in Canada today and has resulted in many deaths, particularly among young people (Shield et al., 2011).The government even has a website dedicated to the opioid crisis in Canada.
Taking more than one drug at a time can lead to unpredictable problems whether the drug is non-prescription, prescribed, or a vitamin (or other “healthy” drug). Drug interactions can affect the absorption rate, distribution throughout the body, metabolism, and the elimination of a drug, and one drug can diminish or exacerbate the pharmacological effects of another drug. Drug effects are known to be somewhat different among the elderly as well as among people of different weights and overall health, among other things. Pharmaceuticals are routinely tested and prescribed on the assumption that the average user is a male in his thirties. The elderly, on average, differ significantly from the average 30-year-old male. They are more likely to be female, to have slower metabolic rates, to weigh less, and to have some cognitive deficits. For those reasons alone, aside from multiple medication use, the elderly are more likely to experience drug reactions than younger adults.
The use of over-the-counter drugs , including supplements and natural health products, often exacerbates the problems noted above. One study found that as many as 70 per cent of the elderly take over-the-counter medication without discussing this with their physicians. Incidences of medication errors by the elderly have been well documented and many of them are in addition to the standard problems elucidated in Table 14.1. These include: forgetting to take medication, taking a smaller or larger dose than that prescribed, taking medication for the wrong reasons, being unable to read labels, having difficulty opening containers, and having impaired memory. Consequences of such drug misuse include falls, dizziness, various illnesses, hospitalization, and even death. If current trends continue, drug use will increase because the rate of drug use for those over 65 is higher than for any other age group, and this part of the population is growing the most quickly.
Females are consistently heavier prescription drug users than males. This pattern of greater use of prescription drugs among females is true of a wide variety of drugs. Those in lower-income groups spend a greater percentage of their incomes on prescription drugs. They also spend a higher percentage of income on food and shelter. In regard to prescription drugs, however, this may be the result of more expensive drugs, as there is some evidence that prices for the same drug can vary considerably, depending on the location where it is sold. It bears mention that pharmacies are essentially competitive businesses and are governed, therefore, by market principles. People in poorer, rural, or isolated neighbourhoods tend to lack the mobility (e.g., automobile transportation) required for comparison shopping and are thus more apt to pay whatever the going rate in the local pharmacy happens to be—or to not use the drug.
All provinces have introduced drug programs to subsidize medication purchases by low-income families (Lexchin, 1996; Dewa et al., 2005; Esmail, 2015). However, these programs vary widely from one province to another. The income level at which coverage begins varies. The deductible varies, and the premium varies. Everywhere there is coverage for catastrophic illness for low-income Canadians. People on social assistance also have universal access to drugs at a very reduced cost with low premiums and low deductibles. While efforts are being made, the cost of drugs for a low-income person may be significant relative to discretionary income. Moreover, the presence of a deductible, a premium, or a required out-of-pocket payment from a person with lower income can decrease the likelihood that the prescription will be filled (Law et al., 2019). In this context there are calls for pharmacare or universal drug coverage similar to medicare.
There is a high correlation between the number of visits to a physician and the number of prescriptions. In the US, 76.1 per cent of doctor visits result in a prescription for a medication (Centers for Disease Control and Prevention, 2019). The figures in Canada may be somewhat lower because we tend to have a slightly less interventionist/aggressive system. On the other hand, a sizable proportion of Americans do not go to the doctor at all because they lack medical insurance. Thus, it is difficult to estimate the correlation between doctor visits and prescription receipt. In Chapter 10 we saw that the number of physicians in a society affects the degree of medicalization. Physicians in general have a tendency towards medical intervention (e.g., to prescribe drugs) when confronted with a patient exhibiting a problem. Various social characteristics and conditions of patients affect the rates at which doctors prescribe drugs just as they affect other aspects of medical care.
Research has documented significant deficiencies in doctors’ knowledge about drugs (Tannenbaum & Tsuyiki, 2013). Commercial sources of information, including drug advertising and salespersons, are significant influences on doctors’ prescribing habits: the more heavily a drug is promoted the more it is prescribed, despite the fact that doctors themselves believe that “they used scientific sources and shunned commercial ones” (Mintzes, 2010). This may be a growing problem as physicians and patients come to rely more and more on the Internet, where health sites are frequently funded by the pharmaceutical industry even though this link may be invisible or obfuscated in one way or another (Usher & Skinner, 2012). One study, for example, found that more than 70 per cent of physicians made claims about particular drugs that reflected the claims made in drug advertisements even though these claims were diametrically opposite to those in the scientific literature (Mintzes, 2010). Doctors have tended not to be critical of drug advertising. They have tended to trust it and it has been incorporated into medical education through textbooks and guest speakers. Medical schools have just recently begun to develop policies limiting the potential for conflict of interest in medical education among both students and faculty (Glauser, 2013). Still, numerous studies have found that when patients go to doctors asking for particular drugs they have seen advertised, they are more likely to get them (including the particular brand requested) than not.
Good prescribing by physicians involves maximizing effectiveness, minimizing risks, minimizing costs, and respecting the choices of patients (Lexchin, 1988, p. 254). In the context of widespread direct-to-consumer advertising , this list now needs to include patient education because patients are often demanding drugs they have seen advertised on television, in magazines, or online, such as anti-depressants that may be of less help and that may be harmful. Even though there are very few studies of appropriate drug prescribing in Canada, those that do exist do not suggest that the values elucidated above are often realized. Drugs may be prescribed when less invasive options such as diet change should be tried first, as is the case in many of the cholesterol-reducing drugs that are so widely prescribed. Even if drugs are prescribed when needed, there may still be problems in drug administration such as dose, rate of absorption, and duration. Studies of elderly people have examined and confirmed the potential of inadequate prescribing. For instance, a study of prescribing in Alberta found that over 2,600 of the elderly population (1.1 per cent) had prescriptions for two or more non-steroid anti-inflammatory drugs (NSAIDs) dispensed on the same day, despite the fact that there is little, if any, rationale for such a practice. In addition, with respect to one of the mood-altering drugs—diazepam—a detailed study found that 14,000 elderly people (3.7 per cent of the province’s elderly) received a potentially inappropriate prescription—often from a single physician, i.e., this over-prescription was not entirely or largely the result of seniors visiting more than one doctor at a time for the same problem. Adverse drug reaction is one of the top 10 causes of death in Canada today (Canadian Foundation for Health Care Improvement, 2010; Talmazan, 2017). This problem is exacerbated by the uptake of higher-cost newer drugs designed to replace older drugs, which thus increases the profit for pharmaceutical companies. In fact, one in five such new drugs will likely be found to be unsafe or will be withdrawn from the market (Canadian Foundation for Health Care Improvement, 2010), despite the fact that new drugs have to have regulatory approval after having gone through clinical trials to ensure their safety and effectiveness. This problem is exacerbated by the difficulty that Canada faces in removing drugs from the market once they have been approved.
“Safe” is a relative term, as there are virtually always some side effects and some of these may be more or less severe for users. Moreover, clinical trials are not absolutely perfect. As with all research, there are limitations. For example, women have long been excluded because of the possibility of pregnancy and because of the known cyclical and changing nature of their biochemistry through their reproductive cycles. The elderly have often been excluded for convenience or because of the (presumed) possibility that they may be suffering from another disease other than the one whose treatment is being evaluated. Also, while clinical trials may ensure the new drug is being used explicitly and exactly for the problem for which it is designed, off-label use and prescription are endemic. In fact, clinical trials are able, for a variety of reasons, to predict only about half of all serious adverse effects. In addition, all adverse effects are never known because reporting is voluntary and many people either do not know to or know how to report adverse effects (Canadian Foundation for Health Care Improvement, 2010)
The typical Canadian doctor prescribes only a very limited number of the many thousands of drugs presently on the Canadian market. Doctors in different specialties tend to have different drugs that they typically prescribe. Sometimes these go-to drugs are the new drugs that have been recently been developed and aggressively advertised. At times any given patient goes to more than one doctor, including different specialists, because of having different chronic or acute conditions. This can lead to polypharmacy. If each doctor prescribes medications for discreet issues but does not know that the patient is taking a number of pharmaceuticals a patient can end up taking too many drugs or drugs that interact with one another. Also, some or many practising doctors, even though they know that reliable sources of information about prescribing include continuing medical education, peer-reviewed journals (many of which are now easily available online), and association meetings, rely largely on pharmaceutical company sales representatives. These sales reps, as a rule, avoid discussing the side effects and contraindications of their medications, or their efficacy as compared to other drugs. Drug salespeople are incentivised to make only positive and, thus sometimes, incorrect statements about the drugs they are promoting.
Research has repeatedly shown that the more frequently physicians see drug sales representatives:
· •the more likely they are to prescribe drugs even when not using drugs is the best option;
· •the more often they adopt the commercial view of a given medicine;
· •the more likely they are to prescribe inappropriately;
· •the less likely they are to prescribe generically;
· •the more likely they are to use more expensive medications when equally effective but less costly drugs are available.
· Pharmaceutical firms are a major source of information for doctors and now patients and consumers about to become patients. The pharmaceutical industry works to control information about its products in a variety of ways. This influence is increasingly powerful in the context of globalization, the Internet, and Internet advertising (Usher & Skinner, 2012). Drug companies fund researchers to test their new products (and have been known to contractually prohibit publication of any but positive results from such research (Mather, 2005). Further, industry-sponsored research has a far greater likelihood of generating positive responses from physicians and the public than non-company-supported research, because the drug companies have the money to advertise their research and corporate involvement in research leads to a greater likelihood of positive results than non-company-sponsored research. The industry also financially supports medical conferences, clubs in medical schools and hospitals, and continuing education events. Numerous gifts are given directly to physicians, including free drug samples, wall charts and posters, three-dimensional models, pen sets, and notepads. They serve to influence doctors to use their drugs. Unfortunately, many sources of information provided by industry to doctors have been found to be in error or misleading (Mather, 2005).
· Nonetheless, many doctors learn much of what they know about medicines and their “appropriate” use from drug firms. There is no lack of evidence to document that the drug company representatives who call on physicians regularly with brochures, samples, and gifts are a major source of information about drugs for doctors. If expenditures by drug companies on promotion and advertising are any indication—they spend twice as much on pushing their products as they do on research and development—then these activities have an important impact on prescribing (Rachlis & Kushner, 1994; Gagnon & Lexchin, 2008). In the United States, pharmaceutical companies spend more on advertising than does, for example, the alcoholic beverage industry. Drug advertisements have repeatedly been criticized as misleading and incomplete, and as portraying people in stereotypical ways. For instance, the elderly may be seen engaging in passive activities wearing depressed faces or acting childishly (Foster & Huffman, 1995). Advertisements recommend drugs for such a variety of everyday, “normal” concerns that drugs seem to be suggested as useful to everyone at least some of the time. Drug prescribing, then, is often a symptom of the tendency towards the expanding medicalization of social issues.
· Another major source of information for most Canadian doctors is the regularly updated Compendium of Pharmaceuticals and Specialties (CPS), a Canadian Pharmaceutical Association publication. Although the Canadian Medical Association Journal has recommended this as a source of information (Lexchin, 1984), it may be inadequate in a number of ways. It may not be comprehensive, and it is known to have continued recommending certain drugs long after research documenting dangerous side effects had been published in medical journals. The most thorough study of its value, done over 30 years ago, found that 46.3 per cent of the drugs listed by the Compendium were “probably useless, obsolete, or irrational mixtures” (Bell & Osterman, 1983). Well-known risks and negative effects were ignored for over 60 per cent of the drugs listed. Scientific errors regarding the biochemical effects of nearly 40 per cent of the entries were evident. Bell and Osterman were led to conclude that the CPS at that time was basically a tool to promote the interests of drug companies. More recent critiques of pharmaceutical regulation suggest ongoing reasons for skepticism and caution in assuming drug safety (e.g., Stelfox et al., 1998; Whitaker, 2010; Lexchin, 2012) and effectiveness even when drugs are used for the purposes officially intended.
· What other factors influence doctors’ decisions about prescribing drugs? Freidson (1975) distinguishes between client-dependent and colleague-dependent forms of medical practice. His argument is that regulation is more effective in colleague-dependent than in client-dependent practices. When doctors have to account to other doctors for the diagnoses they make and the treatments they choose, they are likely to exhibit higher medical standards than when primarily seeking to satisfy the patient. Following this line of reasoning, it can be predicted that doctors who are involved in medical networks or in some form of group practice are more likely to have appropriate prescribing habits.
· Surprisingly, perhaps, especially as it contradicts the common perception, physicians who see fewer patients may spend more time with them but also prescribe more medications. A Canadian study compared a group of doctors who worked on the basis of fee-for-service with a group of doctors who worked on salary (Lexchin, 1988). Approximately one-half of the doctors in private clinics, as compared to one-quarter in community health centres, prescribed drugs inappropriately. Doctors in private clinics spent less time per patient. Salaried physicians were more likely to warn patients of side effects and other potential problems. The researchers explained that because salaried physicians had more time per patient, they were able to take the time to prescribe appropriately and to explain when and how to use the drug, as well as potential side effects.
· Several studies (e.g., Lexchin, 1994b) have shown that both drug advertisements and drug detail men and women (pharmaceutical company representatives who visit doctors with samples and information about drugs) significantly affect the drug-prescribing habits of doctors. Lexchin (1994b) indicates that much of the over-prescription of antibiotics, stomach ulcer medications, and anti-hypertensives results from drug advertising. The Canadian Medical Association and its journal historically defend the pharmaceutical industry and support its viewpoints (Lexchin, 1994a). Given the amount of money involved, perhaps this is not surprising. The drug industry is also heavily involved in supporting medical education. Apparently almost 56 per cent of the medical residency programs in the US received monies from the pharmaceutical industry (Kondro, 2010a, 2010b). The pharmaceutical industry also is heavily involved in the publication of medical journals and in medical research (Insel, 2010).
· Robert Whitaker, who makes the case in Anatomy of an Epidemic that the rise of mental illness in the US is the result of pharmaceuticals, cites evidence of the biased trials of psychotropics funded by pharmaceutical companies (Whitaker, 2010, pp. 299–300); of the rescinding of an appointment to the University of Toronto of a researcher for having exposed his findings that suicidal thoughts are caused by SSRIs (pp. 305–6); of the suppression of the results of research studies (pp. 307–11); of inappropriate acceptance of money by academic psychiatrists (pp. 322–5); and of the invention of psychiatric categories of illness to “cover” the conditions created in children by the effects of drugs unnecessarily prescribed (pp. 325–6). The psychiatric profession routinely emphasizes to schizophrenic patients “the importance of remaining on medications as prescribed”; however, the spectrum of outcomes in schizophrenia patients has been shown at times to be superior when they are off antipsychotic medications (p. 117).
· Another powerful influence on the prescribing habits of doctors is direct-to-consumer (DTC) advertising. Although this form of advertising is illegal in Canada, Canadians view television from the US and read newspapers and magazines published in the United States. One study found that 87.4 per cent of Canadian patients reported seeing DTC advertising (Mintzes et al., 2003). Interestingly, physicians were likely to give patients drugs that the patients, having seen advertisements, had requested (between 72 and 78 per cent of patient requests were filled). These figures compare to a rate of 12.4 per cent of prescriptions given to patients who had not specifically requested them. Direct-to-consumer advertising has been shown to be effective in increasing the sales of particular drugs (Mintzes et al., 2002). According to a cross-sectional survey of primary care physicians in Vancouver and Sacramento, there is a significant likelihood, regardless of the patient’s health status, drug payment method, or gender, or of the medical specialty of the physician or number of years in practice, that patients who request a particular drug will be given it. Furthermore, physicians indicated that in at least 40 per cent of the cases in which they prescribed a drug at the request of the patient the physicians were ambivalent about the prescription of the particular drug. Clearly, patients’ requests for certain drugs are a powerful factor in the prescribing habits of physicians, despite their possible professional reluctance. There is a direct link between the amount of advertising for a particular drug and the rate of its prescription (Mintzes et al., 2003).
· This evident lack of respect for good and systematic knowledge about the efficacy and safety of drugs is exacerbated by the fact that there is no routine, ongoing monitoring of drug effects on an individual or population level in Canada. It is impossible, then, to link specific health outcomes to specific pharmaceutical interventions. It also is impossible to determine whether the use of newer and more expensive drugs results in better outcomes. As Zitner says, “auto repair shops, computer service technicians, and many other industries routinely contact people to learn if service was satisfactory” (Zitner, 2002, p. 2). By comparison, he argues, it would seem to be a good thing if our health-care system provided more systematic follow-up. Furthermore, Health Canada apparently has no record of what drugs have been withdrawn (or why) because of safety concerns (Lexchin, 2005). As Lexchin (2009, p. 3) writes, “Health Canada has explicitly rejected the development of quantitative standards for evaluating its post-marketing pharma-surveillance system.” The present methods of monitoring the effects of drugs, once they are on the market and used by the public, are very weak. The post-market surveillance system is underfunded and understaffed. As a consequence, there is a significant level of under-reporting of adverse effects both by the public and by health professionals (Fuller, 2010).
There were approximately 42,500 licensed pharmacists working in Canada in 2019, according to the Canadian Pharmacists Association. This number represents a substantial rate of growth over the past decade or so. Little sociological analysis exists of the role of pharmacists with respect to prescription and non-prescription drugs. Unquestionably, however, they have considerable discretionary influence in making recommendations both to doctors and to individuals who shop for prescribed drugs as well as for over-the-counter drugs. Consumers frequently ask the pharmacist for advice on over-the-counter medications for a cough, sleeplessness, pain, or anxiety. The pharmacist may suggest a particular brand-name drug or a range of suitable products of different brand names. A number of factors will affect the pharmacist’s recommendation. Discussion about legally broadening pharmacists’ scope of practice beyond these limited tasks has been ongoing for some time. Among the reasons given for altering their present legal status are the following:
1. 1.The accessibility of pharmacists to the public is greater than that of physicians, and pharmacists already have been advising and monitoring patients in regard to drug therapy for decades.
2. 2.Pharmacists may have a professional relationship with patients that is legislated and that encompasses ethical and professional responsibilities.
3. 3.Usually, the pharmacist is expected to assess prescriptions independently. Frequently, the pharmacist questions the patient to ensure that the need for and the use of the drug are fully understood.
4. 4.Physicians often lack sufficient and appropriate information regarding the drugs they prescribe for patients.
5. 5.Pharmacists already give a significant amount of advice on over-the-counter medications to patients.
Pharmacists do have discretionary power when presented with a drug prescription. Unless the physician has written “no substitution” on it, pharmacists are free to dispense any company’s brand of a particular drug. They are also now able to renew prescriptions, refuse to fill prescriptions, initiate drug therapy for a number of self-limiting conditions, and substitute prescriptions (Tannenbaum & Tsuyiki, 2013). Depending on the province in which they work, pharmacists can order and interpret the findings of lab tests. Further, there is evidence of the effectiveness of an expanded role for pharmacists in the management of a number of chronic diseases such as diabetes and in avoiding or predicting adverse drug events.
The Canadian drug industry has always been divided into domestically owned companies, the first one founded by E.B. Shuttleworth in Toronto in 1879, and foreign-owned subsidiaries, the first of which was established in Windsor by Parke, Davis and Company (Lexchin, 1984, p. 331). The industry grew slowly (the foreign-owned companies stayed in Canada because they could obtain tariff and tax advantages) until the 1940s. The antibiotic revolution and the development of medications to control patients in mental hospitals spurred the rapid growth of the industry. Economies of scale became possible in the manufacture of these drugs, and production was centralized. Centralization, plus the increasing openness of world trade—globalization—meant the small Canadian companies could not compete with the larger foreign-owned companies.
After World War II, only one Canadian company of any consequence—Connaught Laboratories—was left, but today Canada’s domestic drug manufacturing industry is significant. Indeed, the pharmaceutical industry is one of the more profitable manufacturing activities in Canada. The median rate of return for shareholders of large pharmaceutical companies is about twice the median for all manufacturing: 20.1 per cent as compared to 9.8 per cent (Lexchin & Wiktorowicz, 2009). High profitability and the probability of consistent growth due to long-term demographics (e.g., the aging of the population) provide reasons for the likely continuation of this trend. What strategies do the drug companies use to maintain their profitability? What is the impact of the great financial success of the multinational drug companies on the health of Canadians and on the health of the people in less-developed countries? In what way do the profit-making strategies of the drug companies affect health negatively? These three questions will be discussed here.
The pharmaceutical industry has been successful in maintaining its position as one of the most profitable industries through a variety of strategies, including: (1) the absence of a link between manufacturing cost and price; (2) patent protection; (3) competition and drug development focused on drugs with widespread potential for use (and thus profit) rather than on drugs for rare conditions; (4) production of brand-name rather than generic products; (5) drug distribution (dumping) in less-developed countries; (6) the change in the availability of many drugs from prescription only to over-the-counter consumer purchase; (7) drug shortages; and (8) advertising and providing select information to physicians and consumers
One of the major reasons for the high profits in the drug industry is that the selling price of drugs is not directly related to drug production costs (Lexchin, 1984, pp. 41–8). Manufacturers are free to determine prices in the interest of maximizing their profits. Variations in the cost to the consumer bear little or no relationship to manufacturing costs. Instead, prices reflect Canada’s patent system, the relationship between Health Canada and the industry, the types and costs of research and development undertaken, and advertising costs, among other things (Lexchin & Wiktorowicz, 2009). This is intended as a profit-making industry. It is not dedicated to service or the well-being of the citizenry. It is accountable to its stockholders. While high profitability is the case in the pharmaceutical industry worldwide, it appears to be particularly so in Canada. Individual Canadians have the fifth highest expenditures on pharmaceuticals among countries in the OECD. The average per capita expenditure in the United States is $1,162, followed by Switzerland at $982, Japan at $798, Germany at $766, and then Canada at $756 per capita. There is wide variation in pricing for drugs from country to country. This is also reflected in the fact that, in recent years, some US citizens from border states have regularly crossed into Canada to buy prescription drugs with Canadian dollars in order to save, and others have bought online using the relative advantage of today’s American dollar. In the recent past, though, when the Canadian dollar was about at par with the US dollar, Canadians could sometimes save by crossing the border (virtually and actually) to fill prescriptions in the US. Online purchasing of pharmaceuticals may save money for the consumer and it is expanding. However, it challenges all of the patenting and safety concerns discussed. Errors and adverse effects will be even less likely to be monitored when purchases are across borders through the Internet and the global pharmaceutical industry. Moreover, the future ability of individual countries to regulate drug costs and availability is threatened today by the accessibility of online pharmaceuticals.
Patent protection is the second technique used to maintain the high level of profits. Patents limit competition. Once the company has invented a new drug, patent protection gives the company an exclusive right to manufacture and distribute the drug for a period of years. Determining the length of time that a new drug is protected from competition is a difficult matter. It depends on the relative power of the industry as compared to the governmental options. Industry pays taxes, offers jobs, and employs workers who also pay taxes. Canada provides patent protection for a minimum of seven years but generally 10 years for new drugs before generic drugs are marketed (Lexchin & Wiktorowicz, 2009). This period can be extended if the company takes out additional patents on associated drugs. Drug companies claim that patent protection allows them to pay for the research and development involved in the invention of new drugs. However, critics challenge this idea because much of the research done in any drug company is directed towards developing imitative medicines that can compete with products already successfully developed and marketed.
Highlighted Issues
Box 14.3 • Antibiotic Resistance
In the 1940s antibiotics were introduced. They were viewed as “miracle” drugs. They were able to keep people alive who would have died from pneumonia, tuberculosis, infections in wounds, and sexually transmitted diseases. Now, however, antibiotic resistance (or ineffectiveness) is growing (Branswell, 2002). The US Centers for Disease Control has confirmed that one of the most common and difficult of infections is becoming resistant to vancomycin, the strongest antibiotic presently available. The presence and spread of vancomycin-resistant staph aureus (VRSA) may herald a day when there is no antibiotic solution for the many bacterial diseases whose treatments, since the 1940s, we have come to take for granted (Branswell, 2002). Bacterial diseases have again become a serious threat to health here and around the globe (Ventola, 2015)
The major reasons for the growth of antibiotic resistance appear to be their inappropriate use for treating infections in people, animals, and plants. Sometimes antibiotics are prescribed when they are not necessary because the presence of bacterial rather than viral infection has not been documented. Sometimes people fail to take antibiotics as they have been prescribed. Bacteria are able to constantly adapt to survive. When antibiotics are used inappropriately bacteria have opportunities to change. When antibiotics are used in animals and plants they enter the human food chain and the water, land, and even air (Batt, 2010). Dumping of excess antibiotics and their excretion via the human body are other processes that increase the growth of antibiotic resistance in populations. The popular use of anti-bacterial soap and alcohol-based hand sanitizer is also associated with the development of resistance (Batt, 2010).
The third strategy is that the drug companies rarely do research or attempt to develop medicines in areas where there is unlikely to be a large market or with a view to addressing the needs of people with less-than-common diseases or when the materials for the medication are not subject to patent (Lexchin & Wiktorowicz, 2009). Rather, they tend to develop and produce new drugs based on similar existing drugs, thus maintaining patent protection for large markets that have already been developed. As an example, numerous anti-inflammatory (anti-arthritis) and benzodiazepine (minor tranquilizer) and anti-depressant drugs are currently on the market in Canada (Lexchin, 1988a; Lexchin & Wiktorowicz, 2009). Such a wide choice is of virtually no therapeutic or medical value; indeed, the value of benzodiazepine and of anti-depressants (Whitaker, 2010, pp. 126–47, 149–71) is open to question. However, because of the huge market for these two drugs, most every pharmaceutical company has a similar product. The development and introduction of “new” drugs sometimes appears to have more to do with profitability than with medical value.
Fourth, the use of brand-name rather than generic products contributes significantly to the profits of the pharmaceutical companies. (The generic name is the scientific name for a particular drug, while the brand name is the name given to, and advertised by, the drug by the pharmaceutical company that produces it.) On average, generics cost considerably less than the most expensive brand-name equivalents. It is clearly to the advantage of the pharmaceutical industry to promote brand-name products. Although when brand-name products are prescribed, the pharmacist may substitute a generic if it is available (unless otherwise directed by a physician). Paradoxically, however, that may not always be done because the economic viability of the pharmacies selling drugs is an important part of the pharmaceutical industry and another source for profit potential.
Fifth, the history of the pharmaceutical industry is replete with stories of drug-related illness and death. The dumping of out-of-date drugs in the developing countries is one example. The health-destroying side effects of many drugs, whether they are taken alone or in combination with other drugs, are an ongoing problem. The industry sometimes markets drugs for a wide variety of symptoms when they are appropriate for only a limited number of purposes.
Many countries in the developing world face serious problems in relation to pharmaceuticals. One problem is a lack of drugs, including vaccines that have come to be considered essential in the developed North. Other drugs known to extend or improve the quality of life in a chronic and potentially fatal disease, such as AIDS, are much too expensive for the vast majority of the world’s population. For instance, while protease inhibitors could lengthen the lifespan of people diagnosed with HIV/AIDS, they are completely out of financial reach for most people in many countries where people cannot even afford a condom. Aside from the costs and the lack of availability, there are other equally serious problems in less-developed countries: at times, drugs are used inappropriately because they lack directions for use or these directions are written in a foreign language (i.e., English), or the consumer lacks literacy, or they are to be taken with water that may be unsafe or lacking. Sometimes drugs banned in one country are shipped to and sold in a different country that lacks the regulatory infrastructure to protect its population (Ollila & Hemminki, 1997, p. 309).
Sixth, a number of drugs that were formerly available only by prescription are now available as over-the-counter (OTC) purchases. This may increase the sales of such medications. Emergency contraception (the so-called “morning-after” pill) is one example (http://www.planb.ca/where.php). Now that this emergency contraception can be purchased over the counter it may be more widely used in a situation of fear of pregnancy. This trend to over-the-counter medications may seem a progressive step in that it promotes self-care, but the availability of OTC medications that formerly had to be gotten by prescription also boosts sales. In addition, this move saves medical insurance companies money because they do not pay for any but prescription drugs, and this increases the size of the private health-care system and the out-of-pocket expenses for many Canadians.
It is incorrect to assume that a drug licensed in one country is necessarily appropriate for another group because populations may differ in “metabolism, weight, and nutrition—and these are known to affect the efficacy, safety, occurrence of side effects, and acceptability of a drug” (Ollila & Hemminki, 1997, p. 323). For example, the World Health Organization found that schizophrenics had a better outcome in the less-developed world, presumably because they were far less likely to be drugged and because their social policies and cultural values for the mentally ill were more supportive (Whitaker, 2010, pp. x–xi).
Drug licensing is important for ensuring safety and efficacy. National governments are responsible for drug regulation. This inevitably means that prescription drug regulation is uneven around the world. Even in the industrialized world conflicts of interest are faced by pharmaceutical companies and their scientists regarding the need for licensing and regulation. Because a patent gives a drug company the exclusive right to manufacture and sell a particular drug for a limited period of time—and because patented drugs are much more profitable to drug companies—it is in their interest to speed a newly patented drug through the approval and regulatory boards in order to have the longest time possible to gain from the patent status (Abraham, 1995).
The Dalkon Shield IUD (an intrauterine device for birth control) is one example of the great health costs of a profit-driven industry (Vavasour & Mennie, 1984). The Dalkon Shield went on the market in 1971 in the United States. By early 1972 there were numerous reports of adverse reactions, such as pelvic inflammatory disease, blood poisoning, and tubal pregnancies. By 1974, 17 people had died from its use. Because the US market began to look very poor, the manufacturer offered the Dalkon Shield to developing nations at a discounted price of 48 per cent of the original price. The shields were distributed to the developing nations even though they were unsterilized and nine out of 10 lacked the necessary inserter. Furthermore, only one out of 1,000 was distributed with any instructions for insertion (and their insertion is a delicate and potentially dangerous procedure). In 1975, the United States banned the Dalkon Shield, while continuing to sell them to the developing world (Miller, 1996).
A seventh strategy for maximizing pharmaceutical profits is the intentional creation of drug shortages of particular drugs in Canada and around the world in order to increase prices, even though such shortages can potentially be life- and health-threatening. Several different policy options to prevent drug shortages are being considered (Gagnon, 2012).
The eighth profit strategy is to provide only select information to doctors and consumers about the efficiency and safety of various drugs. On average, drug companies in Canada invested about $10,000 per physician in advertising as long ago as the early nineties (Williams et al., 1993). The advertisements are frequently presented as information. In the event that doctors are very busy with their practices they may be willing to rely on such advertising for information. Drug industry contacts with physicians are systematic and persistent and often include “perks” such as meals, stationery, conference fees, travel expenses, and computer equipment (physicians who prescribe most are most likely to receive these additional perks) (Williams et al., 1993). There is also considerable evidence that pharmaceutical companies restrict the information resulting from research studies that could inform doctors and the public, if the research is not supportive of the companies’ bottom lines (Olivieri, 2010; Whitaker, 2010).
Fifteen general practitioners in Australia were asked to audiotape three encounters with pharmaceutical representatives (Roughead et al., 1998). Seven of these GPs agreed to take part. They asked 24 pharmaceutical representatives to participate; 16 agreed to do so. They were informed that they were being taped. A total of 64 medicines were described (“detailed”) in the recordings. The interpretations averaged 2.75 minutes per drug. However, the information provided by the pharmaceutical company representatives bore very little similarity to the Australian Approved Product Information categories. Thus, there was very little correspondence between the information provided by the drug company representatives and the views and position of the Australian government in respect to indications (for use), pharmacology, pharmacokinetics, side effects, precautions, warnings, interactions, use in special groups, dosage and administration, and availability. Despite the fact that the Australia Pharmaceutical Manufacturers’ Code of Conduct is in place to regulate the marketing of drugs and “includes standards for printed promotional material, pharmaceutical representatives’ activities, competitions, gifts, samples, trade displays, and symposia” (Roughead et al., 1998, p. 270), the results of this study indicate that pharmaceutical company representatives do not comply with standards outlined in their codes of conduct. As recently as 2017, the Ontario government enacted legislation that would have forced doctors to disclose payments from pharmaceutical representatives and companies. Under the Health Sector Payment Transparency Act, passed in December 2017, the province would have developed an online database wherein patients could search to see whether or not their physicians demonstrated a conflict of interest. The implementation of this legislation was delayed pending further consultation with the health sector after the Conservatives took power in 2018. In its policy on “Physicians and the Pharmaceutical Industry,” updated in 2007, the Canadian Medical Association has expressed its concern about the conflict of interest that may confront physicians in their dealings with the pharmaceutical industry. The policy contains separate sections on industry-sponsored research, industry-sponsored surveillance studies, continuing medical education and development, electronic continuing development, advisory consultation boards, clinical evaluation packages, gifts, medical students and residents, and other considerations. While the Pharmaceutical Manufacturers Association of Canada is among the many organizations that have developed codes of ethics similar to those of the CMA, the enforcement of these codes remains somewhat uneven and unreliable.
In sum, the pharmaceutical industry invests in “educating” doctors because this has proven to be an effective strategy for sales in the developed and developing worlds, particularly as direct-to-consumer advertising is illegal in most of the world with the exceptions of the US and New Zealand. If the industry did not know from experience that marketing to doctors and consumers is effective, it would not have spent billions of dollars annually in recent years on this marketing.
The Case of Thalidomide
Just as the pharmaceutical companies have shown that their marketing strategies in developing countries take health less seriously than profits, so, too, have profits come first in Canada at times, and with deleterious consequences. Probably the incident with the most visibly tragic consequences was the thalidomide disaster, which resulted in the birth of over 100 babies in Canada with phocomelia (the absence of limbs and the presence of seal-like flippers instead).
A West German company developed thalidomide in 1954. It was called GRIPPEX, and was initially recommended for the treatment of respiratory infections, colds, coughs, flu, nervousness, and neuralgic and migraine headaches. It was widely available without prescription, quite cheap, and, therefore, very accessible. It was manufactured in West Germany, Canada, Great Britain, Italy, Sweden, and Switzerland under 37 different brand names (Klass, 1975, p. 92). Later it was marketed in Germany as the “safest” sleeping pill available because it was impossible to take enough at any time to commit suicide. It was advertised in Great Britain (where it was called Distavel) as so safe that the picture accompanying an advertisement was of a little child in front of a medicine chest. The caption read, “This child’s life may depend on the safety of Distavel.”
By the summer of 1959 a number of reports in Germany, Australia, and Britain had noted serious side effects. These indicated that the drug caused nerve damage, affected balance, and caused tingling in the hands and feet. This should have been a warning about the potency of the drug and its effects on the central nervous system (Winsor, 1973). But the manufacturer continued to market the drug in Germany and licensed another company to produce and market the drug in Canada and the US. The drug was tested briefly in the US and then samples were distributed. It was manufactured, beginning 1 April 1961, under the name KEVADON in Canada. A warning was included in the package about peripheral neuritis. It was distributed in Canada under a number of different names.
By 1 December 1961 two representatives of the German companies reported to Ottawa that a number of babies with congenital deformities had been born in Germany and that the mothers of these babies had taken thalidomide. Rather than contacting the research centres in Germany, England, and Australia directly, the Canadian government relied on the ambiguous and evasive reports presented by the pharmaceutical companies involved. It was not until three months later, on 2 March 1962, that the Food and Drug Directorate of National Health and Welfare decided to withdraw the drug, claiming that, until then, the evidence for its removal was “only statistical” (Winsor, 1973). Removing the drug was complicated. Unlike France, Belgium, the US, and Britain, Canada did not require the drug manufacturers to label the drug with its international name—thalidomide—under which its side effects were being publicized (Kitchener-Waterloo Record, 1972). As a result, a number of pharmacists were not aware that their shelves contained the drug in question. By the time it was removed the damage had been done.
Approximately 125 babies were born in Canada with phocomelia (Peritz, 2010). Other external defects included small ears, eye defects, depressed noses, and facial tumours. Internal problems were found in the cardiovascular system and the intestinal tract. There were several cases of missing organs, such as gall bladder or liver. These physical anomalies meant emotional traumas for those born with health and body-function problems, as well as for the mothers, fathers, siblings, other family members, and anyone who was involved with the “thalidomide babies.” In some communities the birth of the deformed children made local newspaper headlines, and townspeople “flocked” to the hospital to see for themselves. Some people blamed the mothers for having taken the drug. Whole families were stigmatized. There were approximately 3,000 disabled babies in West Germany and 500 in Great Britain. When Belgium, Sweden, Portugal, and other affected countries are included, the number of babies reached more than 10,000 (Dove, 2011).
Very few cases ever occurred in the US. Dr Frances Kelsey, the medical officer who reviewed safety data for the Food and Drug Administration, was skeptical and critical of the drug. She had, by chance, read a letter to the editor in a medical journal, which presented negative information about the drug ( Kitchener-Waterloo Record, 1972). She was dissatisfied with the available information on the safety of the product and did not allow it to be marketed. In particular, she was concerned that the drug could cross the placenta of the mother. In the US, only the few samples of the drug given to doctors were ever used. Apparently, Dr Kelsey resisted extraordinary pressure from the drug company, which made “no less than 50 approaches of submissions to the FDA” (Winsor, 1973). (Kelsey, who was a Canadian doctor, died in August 2015 at the age of 101.)
The drug companies had used a number of tactics to increase the sales of thalidomide. One involved planting an article in the June 1961 issue of the American Journal of Obstetrics and Gynecology, allegedly written by Dr Ray Neilson of Cincinnati. The article said that the drug was safe for pregnant women (Winsor, 1973). Later, Dr Neilson admitted that the article had been written by the medical research director for the manufacturer and was based on incomplete evidence, i.e., on evidence only that the drug was harmless when taken in the last few months of pregnancy, when, of course, the limbs had already developed. Nevertheless, it was advertised as safe for pregnant women when it was clearly known to be unsafe if ingested in the early months. Canadians were reminded of this tragedy, and of the outcome for the people who suffered physical anomalies and emotional and social scars as a result, when the Canadian Broadcasting Company aired a documentary, Broken Promises, on the events and their aftermath. This documentary revealed the culpability of the Canadian government in failing to keep the drug out of Canada. The Globe and Mail (1989) reported on the program as follows: “the most striking impression left by ‘Broken Promises’ is that a number of pharmaceutical companies, druggists, doctors and prosthesis manufacturers have callously exploited the victims of thalidomide with the crudest and most obvious motive—profit.” In addition, the Canadian government was criticized for failing to provide compensation. It has subsequently compensated and continues to compensate those who were directly affected by thalidomide. An additional class action lawsuit was pursued by others who could not prove their disabilities were caused by thalidomide, i.e., they were unable to provide 60-year-old prescription receipts or affidavits from long-deceased doctors. A hearing for approval of a Settlement Agreement was held in Federal Court in late February 2020 (Koskie Minsky, 2020). However, financial compensation can never be a completely satisfactory conclusion to such a life-changing mishap.
The Globe and Mail reported in February 2010 that many of those affected by thalidomide at birth have numerous health problems and have aged prematurely. As of that date, only 96 people of the estimated 125 born with phocomelia—or rather, those who could prove their mothers had taken thalidomide—were still alive. Some were shunned by their parents throughout their lives. Some now live alone and in poverty. According to the spokesperson for the survivors, “Today, some of Canada’s ‘thalidomiders,’ as they call themselves, live fulfilling lives, with jobs, spouses and children. Most, however, are struggling” (Peritz, 2010).
The Case of DES
From the 1940s through the 1960s, many physicians prescribed the synthetic estrogen hormone DES (diethylstilbestrol) , also called simply stilbestrol, to pregnant women who had histories of miscarriage, diabetes, or toxemia during pregnancy. More than 4 million women worldwide took DES over this period. In the US, approximately 2 million male and 2 million female children of these women were exposed to DES in utero; there are approximately 400,000 children of “DES mothers” in Canada. The girl children have developed a number of health difficulties, including a rare vaginal cancer, adenocarcinoma, and a variety of apparently benign structural changes of the uterus, cervix, and vagina. As many as 97 per cent of the DES daughters have cervical abnormalities. Adenosis, the most common problem, is estimated to occur in 43 to 95 per cent of the women. About one-half of DES daughters have had or may have problems with pregnancy, including primary infertility (difficulty in becoming pregnant), premature births, stillbirths, and ectopic pregnancies (gestation outside the uterus). Ectopic pregnancies, which may be dangerous to the mother as well as the fetus, appear to occur in five times as many DES daughters as in other women. Problems have been seen in DES sons as well. About 30 per cent have genital tract and semen abnormalities, including cysts and extremely small and undescended testicles. The impact of DES has become evident only over the past three decades or so. There may be links between DES exposure in mothers and testicular and prostate cancers in sons. However, all of the long-term effects may not yet be known.
DES is one of a series of hormone-based drug interventions developed in the last century for women. For more than a decade women had been advised to take hormone replacement therapy (HRT) to prevent the “symptoms” of menopause such as hot flashes and night sweats. Millions of women responded and began to take various admixtures of HRT despite the ongoing questioning of the severity of the side effects by the women’s health movement (O’Grady, 2003). Hormone replacement therapies were widely prescribed before research by the National Heart, Lung, and Blood Institute of the National Institutes of Health in the US, with large and significant collaboration of the Women’s Health Initiative, was complete. In the middle of the research on the effects and safety of hormone replacement therapy—three years before all the data were collected—the study was abandoned because HRT was found to be associated with an increased risk of breast cancer, stroke, and blood clots (O’Grady, 2003). After the publication of these results in 2002, the prescription of HRT decreased and, at the same time, the prescription of anti-depressants increased, and it appears that anti-depressants are sometimes being prescribed for the same symptom presentation as HRT.
Other Negative Effects of the Pharmaceutical Industry
Finally, the pharmaceutical industry must also be challenged for being part of a larger set of industries causing ill health. Harding (1987), for example, suggests, “the pharmaceutical industry is an outgrowth of the interlocking petrochemical industry, which also produces pesticides, herbicides and fertilizers.” Toxins from the petrochemical industry have been responsible for environmental health calamities. Sharon Batt (2010) has documented the difficulties we face because of how the drugs we use and those that we throw out unused become a part of our natural world and pollute it in untold ways. For example, there are already trace amounts of pharmaceuticals to be found in the streams, rivers, lakes, and tap water that Canadians rely on. Remember, as you think about this, that pharmaceutical manufacturing is a relatively new phenomenon and thus the effects of long-term and increasing “dumping” of drugs into the environment are not yet known. Chemicals from food and personal products, such as those for cleaning, hygiene, shampooing, and food additives, and new genetic and biological chemicals have all been found in the ecosystem. Just as the methods for detecting such chemicals are improving, so is the growing inventory of the pollutants being uncovered. Although the short-term and the long-term consequences of this pollution are not known, a few cases for concern are already evident. The deleterious consequences for birds and fish of the excess of estrogen products in the water are beginning to be documented. For example, fish living downstream from sewage treatment plants have been found to be feminized and to have lost interest in spawning. Trace amounts of antibiotics, painkillers, anti-inflammatory drugs, hormones, tranquilizers, chemotherapy drugs, and drugs for cholesterol and epilepsy have been observed. Without knowing much about the specific effects of such pollutants, it is easy to imagine possibilities. Drinking water, too, has been found to carry personal care and pharmaceutical products. Some of these chemicals are persistent and do not dissolve or breakdown. The precautionary principle declares that we should not act until we know the consequences of the action. Clearly, the evidence is in that we are already causing harm to the ecosystem by the use of medical, cosmetic, and cleaning and health products. The public health dangers of these industries are potentially widespread and serious.
Issues in Drug Regulation
Governments can have an important role in the regulation of the drug industry and ultimately in the drug-related health of their citizens. However, most government regulations are inadequate. As a result, in Canada: (1) half the drugs now on the Canadian market have never passed modern tests regarding safety or effectiveness; (2) even where regulations are in place in the industrialized world, substandard drugs are being marketed and distributed overseas; (3) drug companies have a monopoly on the information available to doctors as well as on the side effects of various drugs. One reason that the safety and effectiveness of drugs in Canada may even be declining is that responsibility for testing new drugs is increasingly being given over to the industry that manufactures and sells drugs for profit (Armstrong & Armstrong, 2003; Silversides, 2010). The balance of power between the Health Products and Foods Branch and the industry has been moving towards the industry as Canadian government policies have generally moved to the ideological right, with an emphasis on relying on market principles and globalization. In practical terms, this means that the pharmaceutical industry “is now providing a substantial fraction of the money needed to run the drug regulatory system” (Lexchin, 2012, p. 285). Since 1994, pharmaceutical companies have been charged a fee every time they submit a new drug for approval. In return, they have asked for a speedier approval process for new drugs (Lexchin, 2012). “Greater public scrutiny of the drug approval process is essential” (Silversides, 2010, p. 138).
A study of drug withdrawals from the Canadian market between 1963 and 2004 because of safety concerns is instructive in regard to the historical safety of the drugs introduced (Lexchin, 2005). Lexchin undertook a systematic study of drugs that had been removed from the market over a period of more than 20 years. He found it very difficult to get the information because Health Canada “does not maintain a comprehensive list of drugs that have been removed from Canada because of safety concerns” (p. 765). In addition, he notes that even asking the question about withdrawals led to further questions and concerns, such as the fact that drugs tend to be tested for a short period of time on a highly select group of patients, including “those with clear evidence of disease, who are not taking other products and who do not have other conditions that might interfere with an analysis of the efficacy of the product being tested” (p. 765). By contrast, many patients have multiple conditions and unknown conditions, and many use the drugs over a long period of time. In conclusion, Lexchin, who has been studying issues related to the pharmaceutical industry for many years, states that “the current safety system is inadequate” (p. 767).
However stringent the laws, the government cannot guarantee that any drug is safe for all the uses to which it may be put. It is not difficult to imagine a situation in which a drug is prescribed for one use or for one person, and is then used again by the same person on another occasion when the symptoms seem to be similar or is passed on to a friend or a family member who seems to have the same problem. People often regulate their drug use, ignoring the specific directions given by the physician and/or the pharmacist. In addition, people have been known to develop drug allergies very suddenly and unpredictably.
While the government can insist that patients be told about drug interactions, it cannot regulate the actual mixture of drugs taken by any one individual. Some drugs react negatively when taken in conjunction with alcohol. One characteristic of many alcoholics or even people who now and then have a glass or two of wine or a couple of bottles of beer is that they may try to keep their drinking habit secret—even from their doctor. Untold problems result from drug–alcohol interactions. In addition, a number of drug-related problems or side effects are only discovered after long-term use. For these and other reasons, the drug regulations established by the government can only be considered as partial protection.
The Canadian government is also in a weak position because of the Canadian branch-plant economy in the pharmaceutical industry. Most drugs are developed and tested elsewhere. The Canadian government frequently relies on tests done abroad by other governmental bodies or by the drug firms’ research departments. This raises complex problems of biased information from pharmaceutical companies and political problems of intergovernmental relations. Moreover, as Lexchin documents, in spite of the fact that Canadian drug laws are among the strictest in the world, there are still major gaps that may jeopardize people’s health.
Medical Devices and Bioengineering
Medical devices range from contact lenses to CT scanners, MRI machines, knee and hip replacement parts, prosthetics, and beyond. Companies that produce and sell various medical devices, such as artificial heart valves, artificial limbs, kidney dialysis machines, anaesthesiology equipment, surgical equipment, and heart pacemakers, are all medical device companies and are among the largest growth industries in the world. The regulations controlling the industry are uneven, especially under globalization and in the context of free trade. Health Canada has a continuous list of advisories, warnings, and recalls for all sorts of health-related products that are often used by people before they are found to cause death, disability, or disease.
Among the responsibilities of biomedical engineers are the evaluation and testing of equipment, the investigation and explanation of the causes of accidents, and the supervision of the repair of biomedical equipment. There is, however, a shortage of such personnel in Canada, owing in part to the lack of training programs as well as the lack of adequate government investment in monitoring and surveillance. From what limited information is available, it is clear that the whole issue of medical devices and bioengineering needs a great deal of research and more thorough and systematic regulation. At present, the Health Products and Foods Branch of Health Canada does not generally require adequate evidence concerning the potential for harm or benefit, or assurance of the safety of the various devices. The exceptions are for tampons, condoms, contact lenses, and devices implanted in the body for more than 30 days (see the website of the Health Protection Branch of the federal government: www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/index-eng.php). These are accepted for marketing only after the government has examined the evideA study of drug withdrawals from the Canadian market between 1963 and 2004 because of safety concerns is instructive in regard to the historical safety of the drugs introduced (Lexchin, 2005). Lexchin undertook a systematic study of drugs that had been removed from the market over a period of more than 20 years. He found it very difficult to get the information because Health Canada “does not maintain a comprehensive list of drugs that have been removed from Canada because of safety concerns” (p. 765). In addition, he notes that even asking the question about withdrawals led to further questions and concerns, such as the fact that drugs tend to be tested for a short period of time on a highly select group of patients, including “those with clear evidence of disease, who are not taking other products and who do not have other conditions that might interfere with an analysis of the efficacy of the product being tested” (p. 765). By contrast, many patients have multiple conditions and unknown conditions, and many use the drugs over a long period of time. In conclusion, Lexchin, who has been studying issues related to the pharmaceutical industry for many years, states that “the current safety system is inadequate” (p. 767).
However stringent the laws, the government cannot guarantee that any drug is safe for all the uses to which it may be put. It is not difficult to imagine a situation in which a drug is prescribed for one use or for one person, and is then used again by the same person on another occasion when the symptoms seem to be similar or is passed on to a friend or a family member who seems to have the same problem. People often regulate their drug use, ignoring the specific directions given by the physician and/or the pharmacist. In addition, people have been known to develop drug allergies very suddenly and unpredictably.
While the government can insist that patients be told about drug interactions, it cannot regulate the actual mixture of drugs taken by any one individual. Some drugs react negatively when taken in conjunction with alcohol. One characteristic of many alcoholics or even people who now and then have a glass or two of wine or a couple of bottles of beer is that they may try to keep their drinking habit secret—even from their doctor. Untold problems result from drug–alcohol interactions. In addition, a number of drug-related problems or side effects are only discovered after long-term use. For these and other reasons, the drug regulations established by the government can only be considered as partial protection.
The Canadian government is also in a weak position because of the Canadian branch-plant economy in the pharmaceutical industry. Most drugs are developed and tested elsewhere. The Canadian government frequently relies on tests done abroad by other governmental bodies or by the drug firms’ research departments. This raises complex problems of biased information from pharmaceutical companies and political problems of intergovernmental relations. Moreover, as Lexchin documents, in spite of the fact that Canadian drug laws are among the strictest in the world, there are still major gaps that may jeopardize people’s health.
Medical Devices and Bioengineering
Medical devices range from contact lenses to CT scanners, MRI machines, knee and hip replacement parts, prosthetics, and beyond. Companies that produce and sell various medical devices, such as artificial heart valves, artificial limbs, kidney dialysis machines, anaesthesiology equipment, surgical equipment, and heart pacemakers, are all medical device companies and are among the largest growth industries in the world. The regulations controlling the industry are uneven, especially under globalization and in the context of free trade. Health Canada has a continuous list of advisories, warnings, and recalls for all sorts of health-related products that are often used by people before they are found to cause death, disability, or disease.
Among the responsibilities of biomedical engineers are the evaluation and testing of equipment, the investigation and explanation of the causes of accidents, and the supervision of the repair of biomedical equipment. There is, however, a shortage of such personnel in Canada, owing in part to the lack of training programs as well as the lack of adequate government investment in monitoring and surveillance. From what limited information is available, it is clear that the whole issue of medical devices and bioengineering needs a great deal of research and more thorough and systematic regulation. At present, the Health Products and Foods Branch of Health Canada does not generally require adequate evidence concerning the potential for harm or benefit, or assurance of the safety of the various devices. The exceptions are for tampons, condoms, contact lenses, and devices implanted in the body for more than 30 days (see the website of the Health Protection Branch of the federal government: www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/index-eng.php). These are accepted for marketing only after the government has examined the evidence—provided by the manufacturing firm itself---- as to the safety of the device.
1. 1.There is a correlation between people’s socio-demographic characteristics and their drug-taking habits.
2. 2.Psychoactive drugs are among the most heavily prescribed and often misprescribed drugs in Canada. Females, the elderly, and the unemployed are high users. Frequently, chronically ill patients are prescribed two or more psychoactive drugs simultaneously. Often, these mood-modifying drugs are given for social and personal reasons and not for medical problems.
3. 3.Large differences exist in rates of prescription from doctor to doctor and even from one geographic area to another. Doctors receive much of their “information” about drugs from pharmaceutical companies. Other factors in the rate at which doctors prescribe drugs include education, type of practice, and method of remuneration.
4. 4.Pharmacists may tend to recommend drugs that will maximize their profit. Pharmacists may often choose between a brand-name (more expensive) and a generic drug for a customer when filling a prescription. Pharmaceutical companies offer incentives to ensure that the pharmacist will choose their brand.
5. 5.Multinationals control the vast majority of the Canadian prescription drug market. Pharmaceutical manufacturing is one of the more profitable manufacturing activities in Canada. Some of the reasons for this are: the absence of a link between manufacturing cost and price, the presence of patent protection, price-fixing, discount pricing, advertising, and drug distribution (dumping) in the less-developed countries.
6. 6.In several Canadian instances, drug company profits have come before health. One is the case of thalidomide, which resulted in the birth of an untold number of babies in Canada with phocomelia. DES is another drug that was used by pregnant women with disastrous consequences. It is now known that it has caused cancer and many other many abnormalities in the reproductive systems of the offspring of these mothers.
7. 7.The government has not adequately regulated the use of pharmaceuticals in Canada. After-market surveillance continues to be weak. Drug companies control much of the information available to doctors regarding various drugs, including the side effects.
8. 8.The medical devices industry is a profitable and growing industry. Government regulation and monitoring of this industry needs improvement.
C
hapter
14
Introduction
The
medical
-
industrial complex
is a large and growing
network of private and semi
-
public corporations engaged in the business
of providing medical care and medical care products, supplies, and services for a profit. Included in the medical
-
industrial
complex are, among other things, hospitals and nursing home
s, home
-
care services, diagnostic services, including
expensive
CT
scanners and
MRI
s, hemodialysis supplies and equipment, pharmaceutical companies, medical tools and
technology, and even laundry and food
-
packaging companies that supply hospitals and other
health
-
care organizations. This
complex is global and is a part of a new world order (
Usher & Skinner, 2012
) under neo
-
liberalism. The pharmaceutical indus
try,
an important component of the medical
-
industrial complex, will be discussed in detail in this chapter.
When do you decide to go to the pharmacy for over
-
the
-
counter medication? Some of you try to become aware of the side
effects of various over
-
the
-
co
unter and other medications. Some of you ask the doctor about long
-
term effects. Some of you take
your prescribed medication exactly as directed
—
over the length of time suggested and at the prescribed intervals. Most of us
assume that all the drugs availab
le in Canada have been adequately tested and are safe. However, this assumption is not true
(
Canadian Foundation for Health Care Improvement, 2010
). Many of
you will have heard of thalidomide, Vioxx, Ritalin, Diane
-
35, or
DES
. Do you know some of the devastating results of their use? You may have considered the question of the extent to
which the pharmaceutical, medical device, and biotechnology companies are
reliant on and motivated by making a profit as
compared to serving those suffering sickness and pain. Have you ever thought about the effects of pharmaceuticals on the
environment? They may be excreted from our bodies (our bodies only absorb a portion of
the drugs we routinely administer to
ourselves) or flushed as tablets or syrups down a drain when we no longer think they are of use. After a person dies, as the
body
decomposes, the drugs (or chemicals) leech from the body and are absorbed by the earth. T
hese are among the issues that will be
addressed in this chapter.
Drug Use
Any discussion of the pharmaceutical industry and the use of drugs in contempor
ary Canadian society must be fairly wide
-
ranging
because this topic involves a large number of sociological issues. The drug industry is a major actor in Canadian medical car
e, and
its share of health spending in Canada grew from 9.8 per cent in 1983 to 12
.6 per cent in 1990. In 2019, according to the Canadian
Institute for Health Information, 15.3 per cent of the total Canadian health
-
care budget was spent on pharmaceuticals (
CIHI
, 2019;
see
Figure 14.1
). Prescribed drugs make up the largest component at 84.6 per cent and over
-
the
-
counter drugs comprise 15.4 per
cent. There is evidence of the f
lattening of this upward trend line because several “blockbuster” drugs used to treat the high
-
prevalence conditions of hypertension and high cholesterol have moved off patent and thus are now available in the much less
costly generic form. Still, drugs co
ntinue to be the second largest expenditure in the health
-
care system after that spent on
hospitals. Although the proportion spent on physicians has been growing lately, as doctors’ salaries and numbers have both
grown, it is still somewhat less than that
spent on drugs. While the Canada Health Act covers all necessary hospital, physician,
surgical
-
dental, and a
portion of long
-
term care services, it does not include prescription drugs outside of hospital. Thirty
-
one per
cent of prescription drug costs are
covered by private insurance plans, often associated with the workplaces of Canadians, 33 per
cent of costs are paid for out of pocket, and 36 per cent by government programs (for Indigenous people, older people, and th
ose
in the military). The costs to co
nsumers who either lack drug insurance altogether or have limitations in respect to drug coverage
have grown more quickly than the overall health budget. This relative cost of pharmaceuticals constitutes another element of
mounting privatization in health
care in Canada. The proposal for universal pharmaceutical coverage (
Morgan et al., 2015
) paid
through taxation seems to be gaining support. According to
OEC
D
data, Canada is near the top of the
OECD
countries with
respect to the out
-
of
-
pocket cost of pharmaceuticals (see
OECD
, 2018).
In the latest figures, more than 15.3 per cent of Canada’s health budget went for out
-
of
-
hospital drugs, or $1,078 per person
.
Slightly less was spent on physicians
—
$1,064 per person or 15.1 per cent (
CIHI
, 2019
). Hospital expenditures amounted to 26.6
per cent or $1,880 per perso
n, which included in
-
hospital pharmaceutical spending. The amount spent reflects the growing
reliance on drugs for treatment and for prevention. It also represents the adoption of new and thus more expensive drugs,
according to
CIHI
s
National Health Expend
iture Trends
. Greater spending includes an increase in cost for newer anti
-
psychotics
and the uptake of prevalent anti
-
anxiety and anti
-
depression drugs. Drug cost increases constitute another element of mounting
