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Alan Cassels

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  1. The easiest ADR (adverse drug reaction) to avoid is the second one, not the first one. CLOSE TO A DECADE AGO Vancouver resident Johanna Trimble took a seaplane trip to Victoria for an important mission and she brought one important thing. A story. And that story has made all the difference. She travelled that day with two Vancouver emergency room physicians, who invited her along to a meeting with officials at the BC Ministry of Health. The trio’s goal was to try to convince officials at the Pharmaceutical Services Division that BC had a very big, but very solvable problem on its hands. It concerned adverse drug events (ADEs), drug reactions that can be serious enough to cause hospitalizations, serious illness and sometimes death. Johanna was unwittingly thrust into the position of witnessing the care of both her elderly mother-in-law, and her stepmother who were prescribed drugs and hospitalized due to adverse drug reactions. Equipped with both the wisdom to question a drug and the determination to question the doctors, in both cases she managed to get the culprit pills stopped. You’d think that would be the end of the story, but in both cases, the offending drug was represcribed by a different doctor, in a different clinic, and wham, back to the emergency room for a repeat episode. A doctor from a different mold Emergency room physician Dr Corinne Hohl has seen her share of people showing up in the emergency department suffering the effects of prescribed drugs. Adverse drug events are a leading cause of emergency department visits and unplanned hospital admissions. Shockingly, of those in the emergency department because of an adverse drug event, 29 percent are there because they are having a repeat adverse reaction to the same drug (or drug class) that had brought them to the ED previously. Dr Hohl accompanied Johanna on that trip to Victoria, and she speaks with the kind of verve and enthusiasm of someone who’s out to change the world. She recounted an incident that made its mark on her. An elderly woman was admitted to her emergency room in Vancouver General with subdural hematoma—a fairly serious head injury—related to a fall. The patient was taking fairly high doses of fentanyl patches, which were likely the cause of the fall. After being hospitalized for weeks, the patient was slowly switched off the fentanyl to a safer drug. Not long after, the same woman appeared in her emergency room after another fall, this time with multiple rib fractures. “And guess what?” she told me. “She was on the fentanyl again. Basically back on the drug that had previously been related to her fall.” Dr Hohl had been working on how to get a handle on this problem for several years before that meeting with the Ministry. “They thought we were going to show up on the phone but we showed up in their offices in person and their jaws were on the floor.” Her request was concise: she wanted a very simple change to PharmaNet, BC’s comprehensive province-wide drug data system that tracks every prescribed drug in the province. Why not modify it so that it would allow physicians and pharmacists working in hospitals to enter any drug-related ADEs on the patients’ chart? She reasoned that if that information, like an allergy, for example, was a routine part of a patients’ medical record, then the problem of repeat ADEs could be eliminated overnight. “We did all kinds of modelling, to show them how expensive and serious the issue of repeat adverse drug events was. In my presentation I compared it to the opioid epidemic and I showed them how many people died from this problem that is being completely ignored,” she said. Not to be outdone by the enormity of the problem, she also made a promise: “I told them I was going to design a solution for them that was unique across the world.” It helped immensely that Johanna was there—just a regular BC citizen who has seen this problem firsthand, twice. Her story probably helped convince the Ministry of Health officials that change needed to happen. After all, how many BC seniors are on the receiving end of an avoidable prescription mistake that could be fatal? The meeting was probably the inflection point that is now slowly reducing the problem of repeat ADEs in BC. But as Dr Corinne Hohl found out, big system or cultural changes in medicine don’t happen overnight. Research money and pizza From the time that Dr Hohl recognized the problem of repeat ADEs, until some (not all) hospitals began acting on the information from BC PharmaNet, eight years had passed. The delays were understandable but frustrating. Once she got over the bureaucratic hurdles that stymie all but the most determined, Dr Hohl saw that making software changes to a large and impossibly complex computer data system was no walk in the park. And then there’s what is known as the “human factor”—the culture of medicine would need clinicians, nurses, doctors and pharmacists to recognize, record and later seek out any ADEs that are in a patient’s chart. What fuelled her work to make headway on an impossibly complicated task came down to research money and pizza. Many times smart clinicians working in our medical system will see a problem that needs a solution, yet they hit the brick wall of their colleagues or administrators asking “where’s the evidence?” Inertia is easier, and if you don’t have a study to back up what you’re proposing, you better go get one. Dr Hohl went to the research world, getting grants from various sources including the Canadian Institutes of Health Research (CIHR), which helped pay for a gold-standard study, a randomized controlled trial (RCT), and allowed her to tap into the expertise of people on the front lines. A system like this needed a user-friendly interface for physicians and pharmacists, so that meant a kind of “action-research” approach. She worked tirelessly with Ellen Balka, a communications specialist and qualitative researcher at SFU, who helped her dig deep into the principles of behaviour change. This also meant constantly going back to those in clinical practice. “We really needed to bring in that expertise to figure out how clinicians think, work out the details of proper drop-down menus, data standards, and so on,” said Hohl. “We kept buying pizza for the pharmacists. They told us, change this, make this like this, and so on. All those sorts of design features were exceedingly important.” The software application Hohl and her team created is called ActionADE, designed to enable front line clinicians to document adverse drug events by communicating to a central medication dispensing database. Dr Hohl’s system is not province-wide yet, but it has been implemented in nine acute care hospitals already. It still needs ongoing investment to upgrade software and pay for staff, mostly pharmacists, to enter the data into patient records. At the end of the day she has shifted the culture, reminding her colleagues of the enormity of potential adverse drug events, and the need to make sure peoples’ medications are as safe as they can be. All this is part of the growing patient safety movement, where adverse drug events are better known, and many people are becoming aware that tracking and recording them can be lifesaving. Johanna Trimble doesn’t mind being “the voice of the patient” when it comes to speaking truth to power. And she’s darned good at it, becoming one of our province’s most vocal patient safety advocates. About ActionADE she says, “in the absence of such a system, it all comes down to the family. The family has to remember the drug information and these side effects, because nobody else is. The family is the continuity. If the family doesn’t know they have to do that, then somebody might die.” Luckily now in BC, the family is going to get some help in this area. Alan Cassels is a researcher and writer about pharmaceutical policy issues. He lives in Victoria. A webinar discussing Dr Hohl’s research is posted at the website of the Therapeutics Initiative.
  2. Health Canada has now recognized that patients taking certain antidepressants face potential risk of long lasting sexual dysfunction—even after usage stops. Go to story
  3. Health Canada has now recognized that patients taking certain antidepressants face potential risk of long lasting sexual dysfunction—even after usage stops. LATE IN 2019, I met a 23-year-old woman with an unimaginably tragic story. Believing that I might be able to help create some awareness of what she was experiencing, she travelled to Victoria from her home on central Vancouver Island. I knew it was a drug story, but I had no idea what kind of drug story it was. Emily met me in my office in Victoria and I turned on my voice recorder. For the next two hours, her voice often quivering with emotion, she told me how, at 17 and still in high school, she was prescribed the antidepressant citalopram. It is one in a class of selective serotonin reuptake inhibitor (SSRI) antidepressants, a class that includes drugs like escitalopram (Cipralex), sertraline (Zoloft), venlafaxine (Effexor), fluoxetine (Prozac) and paroxetine (Paxil). The psychiatrist told her that it might help her deal with her impulsiveness and depression. Emily admitted that over the years the drug might have helped some, but there was also something very worrying happening: she felt she was losing whatever libido she had. Growing increasingly concerned about how it might be affecting her sexuality, she asked her physician directly if her drug could be the problem. She was assured that the antidepressant might “lead to some loss of libido, but it would come back after she stopped the drug.” Emily was persistent, and eventually her doctor switched her to a different antidepressant which she stopped several months later. She described what happened then: “I woke up one morning to abruptly discover that all sexual sensation I had, disappeared from my body. My clitoris was now no more than an inert and sensationless nub of flesh. I was unable to feel attraction, arousal or orgasm.” Not only did her body seem incapable of responding, the emotional blunting that came with it was almost too hard to take. “Now I wonder if I will ever find romance or love, or have a normal life,” she says, eyes brimming with tears, “Instead of desire and libido returning, they disappeared.” How much do we know? Depending on who you talk to, the syndrome described by Emily, known as PSSD, (Post SSRI Sexual Dysfunction) is either widely known, or completely unknown. Sixty years ago psychiatrist Frank Ayd, credited with discovering the early antidepressant amitriptyline, noticed that this drug affected the libido, causing effects that weren’t otherwise due to the patients’ depression. While psychiatrists might maintain that being depressed can have a seriously debilitating effect on one’s sexual function, over the years published reports and case studies have accumulated, detailing a condition definitely linked to antidepressants, which some people can suffer for months, years or decades. It can include genital numbness, total lack of arousal or orgasm, and a blunted ability to feel emotions. Drug warnings are found in the official, regulator-approved product monograph for antidepressants. The monograph outlines a drug’s pharmacology, research evidence and adverse effects. When SSRIs were launched in the late 1980s, the monographs stated that less than 5 percent of patients reported experiencing some form of sexual dysfunction. This seemed a far cry from what was seen later in unpublished phase 1 trials, where as many as half the healthy volunteers reported some kind of severe sexual dysfunction, even cases where the dysfunction lasted after the treatment was stopped. It was only two years ago that PSSD was officially recognized by the European Medical Agency. Canada, slow as usual on these things, issued a warning in January 2021, signalling that the condition was now officially recognized by our drug regulator. The warning reads, in part: Health Canada will work with manufacturers to update the product safety information for all SSRIs and SNRIs to recommend that healthcare professionals inform patients about the potential risk of long lasting (possisbly weeks to years) sexual dysfunction despite discontinuation of SSRIs or SNRIs.” (serotonin-norepinephrine reuptake inhibitors, another class of antidepressant)… Thirty years to recognize a problem Thirty years ago the data establishing the link between sexual dysfunction and SSRIs in both men and women may have been hard to find in medical journals. Perhaps our prescribing physicians may have been lulled into complacency, hearing nothing from the drug salespeople of the potential sexual dysfunction linked to these drugs. Then along came something that was going to help change all that: the internet. What if there could be a simple, yet systematic way to actually document the experience of real-world patients, so that you could discover, beyond the drug company-massaged medical literature, the experience of the Emilys out there, who were enduring this life-altering, pharmaceutical-induced condition? Wondering how frequent these effects occurred, and generally concerned about the growing sexual problems linked to drugs like SSRI antidepressants, as well as drugs for prostate problems (finasteride) and acne (isotretinoin), Dr David Healy started a website to collect case studies. The key principle of his website, Rxisk.org, is captured in its subtitle: “No one knows a prescription drug’s side effects like the person taking it.” An Irish psychiatrist and psychopharmacologist who works at McMaster University in Hamilton, Dr David Healy has become, probably by accident, the world’s foremost expert on PSSD. Not only does he know the history of sexual dysfunction and psychiatric drugs, he knows about it from the ground up—from first-hand accounts of patients. He has studied and written about this extensively and told me that while some early reports were made to British regulators of a patient with post-treatment genital arousal disorder in the late 1980s, the first report of PSSD was filed with regulatory agencies in 1991. In 2000, he saw his first patient with what was later called PSSD, a 35-year-old woman who told him that three months after stopping treatment, “she could rub a hard-bristled brush across her genitals and feel nothing.” By the end of 2017, he had enough reports to publish his results, a series of almost 300 cases of sexual dysfunction collected from 37 countries and linked to 14 different drugs. He wrote that some symptoms were unique to antidepressants, such as premature ejaculation and persistent genital arousal disorder (PGAD), but other drugs were also linked to “genital anaesthesia, pleasureless or weak orgasm, loss of libido and impotence.” The implications of his paper were huge, because, finally, here was a body of research that could make regulators around the world act, and start warning physicians, and in turn patients, of the sex-destroying potential of these drugs. To strengthen the warnings on these drugs, Dr Healy and his colleagues filed petitions on the sexual side effects of SSRIs and SNRIs with the US FDA, Health Canada and the European Medicines Agency (EMA). Two years ago the EMA was the first to issue warnings of SSRI/SNRI antidepressants and their links to sexual side effects. Concerned that our regulator was dragging its feet, in March of 2020 he wrote Health Canada and said that if the regulator didn’t warn our doctors about the “persistent sexual dysfunction” associated with these drugs then patients were going to continue to be dismissed by their physicians when they try to report these problems. How aware are our physicians? It seems astonishing to say this but Dr Healy contends that almost everyone taking an SSRI/SSNI experiences some form of sexual dysfunction. Thankfully, some of that effect is transitory and minimal, yet for others, people like Emily who have been reporting their symptoms and joining online chat groups around the world to exchange information, this is no small matter. For them, the impact is profound, with faint hope of any cure at the moment. And they are angry. For David Healy, the facts indisputably show that SSRI and SNRI antidepressants often cause sexual dysfunction in both men and women. He estimates that given current prescribing rates, as much as 20 percent of the population may not be able to make love the way they want as a result of the drugs. He also believes that for the sake of prescribers and patients our regulators need to act immediately to implement an effective warning system that can reduce the potentially catastrophic impact on the sexual lives of our citizens. It all comes down to what Emily refers to as “informed consent.” She doesn’t think that antidepressants should be banned or that people shouldn’t be prescribed them, when there is no alternative. It was the not knowing that stings so much. “None of the doctors over the years ever mentioned the sexual side effects of these drugs. Not a word,” said Emily, the anger rising in her voice. Asked why she came to me to tell me her story she was firm: “I don’t want anyone else to go through what I’m going through.” What does this have to do with the pandemic? If there is one thing that is clear about the pandemic, it’s that many people are struggling with mental health issues. Physician visits via the internet are now a fixture, and a model that may even more rapidly expedite the prescribing of psychiatric drugs. SSRI/SNRIs are among the most widely prescribed antidepressants in the world and it is pretty clear that the use of these drugs during the pandemic has been skyrocketing. Reflecting a rate that is slightly lower than the Canadian average, about 15 percent of the population in BC was, pre-COVID, taking some form of antidepressant. The pandemic-related growth in those rates over the last year are concerning. A recent CBC news report says that insurance claims in Canada for SSRIs have grown by 25 percent over the last year. Time will tell whether that means many more people will suffer sexual difficulties due to antidepressants, but we know one thing: people in Canada cannot now say that they haven’t been warned. Alan Cassels is a drug policy researcher who lives in Victoria, BC.
  4. Posted October 20, 2020 Image: A coronavirus testing facility Are we headed to dangerous levels of overdiagnosis by interpreting a test in a way that labels people as sick and infectious when they may be neither? Go to story
  5. Are we headed to dangerous levels of overdiagnosis by interpreting a test in a way that labels people as sick and infectious when they may be neither? EIGHT MONTHS INTO THE PANDEMIC, here are some BC numbers to think about: 5,071,000: Population of BC (est. 2019) 38,471: Typical number of BC deaths in a single year (2019) 132: Number of BC deaths, on average, everyday. (est. 2019) 274: Number of days between Jan. 15 and Oct. 14, 2020 36,168: Estimated number of total deaths in BC between Jan 15 and Oct 14, 2020 250: Number of deaths in BC attributed to COVID-19 up to Oct 14, 2020 0.69: Percentage of total BC deaths over 8 months possibly due to COVID 10,836: Number of “laboratory confirmed” cases of COVID up to Oct 16, 2020 691,741: Number of SARS-CoV-2 tests Jan. 15– Oct 13, 2020 1.82%: Proportion of COVID-19 tests in BC showing as “positive.” As COVID’s daily data dump lands on our heads, shaped by scorekeeping, commentary and predictions, it’s pretty easy to get lost in the numbers and what to make of a nasty pathogen circulating in our communities. What stands out from these numbers? An extremely low likelihood of death by COVID-19 in BC. Certainly lower than any annual toll of the flu. Certainly lower than the numbers of people who have died from cancers, heart attacks, overdoses, suicides and the myriad of other things that take life every single day. If you take 2019 as an average, 132 people per day die in BC, from all causes. That was the last full year without a pandemic virus. With less than one person per day dying of COVID in BC, one is tempted to ask if we’re making a mountain out of a molehill. I’m increasingly surprised by the general subservience of the populace and the absence of thoughtful dissent against emergency measures that are undoubtedly causing all kinds of other suffering, wreaking long-term havoc on our society, our livelihoods and our economy. People are quick to point at our numbers and say what a wonderful job BC public health people are doing, keeping COVID cases down and deaths by COVID at a minimum. We are an obedient lot and so listen to Dr Bonnie, among others, who reminds us to limit contact, wear masks, and control the virus by widespread testing, even if some people have reported how hard the tests are to get. Yet, if it is true that the SARS-CoV-2 causes the respiratory disease COVID-19, how much effort has been put into ensuring the virus test is done properly, evaluated thoroughly and adequately interpreted? Basically, can we trust the test? What is it about the test? Kary Mullis won the Nobel Prize in chemistry 1993 for inventing the PCR (Polymerase Chain Reaction) test, the test that is now being used to ascertain whether or not a person has COVID-19. His test eventually became the standard test that drew the definitive link between the HIV virus and AIDS. Ironically, Mullis himself was at the forefront arguing that PCR should not be used as a tool to diagnose the disease. Why? Because even if it could identify the presence of a virus, that detection did not mean the virus was capable of infecting other cells. An eccentric and vocal iconoclast, with a penchant for dropping acid, Mullis went to his grave last year continuing to decry his test being misused to diagnose HIV. Like many jurisdictions in the world, BC employs RT-PCR to test for COVID. It uses an enzyme called reverse transcriptase to take a piece of RNA (ribonucleic acid) which comes from a swab deep inside the patient’s nose. Adding viral enzymes to the RNA converts it into DNA through what is called Polymerase Chain Reaction. The DNA is turned into billions of copies and a fluorescent signal is added, which, after being run through numerous cycles of heating and cooling, can be detected. This amplification allows the needle in the haystack to be seen. Here’s where things get interesting: The “Ct” or cycle threshold is the number of cycles needed to see the fluorescent signal. So how many cycles of heating and cooling do you need to determine a definitive “positive” or “negative” result? If you don’t detect the virus after a few dozen cycles does that mean the patient is negative? What if you do more than 30 which many molecular biologists say is like trying to squeeze blood from a stone? There may be detectable virus in that highly cycled sample but it is so small and so dead it’ll never be able to infect others. I put some questions about BC’s Ct cutoff to a spokesperson from the BC-CDC and here’s what she wrote back: “The cycle threshold number used to diagnose COVID-19 may vary based on the test used but we typically use a cutoff of 35 cycles.” She added that other targets (the RDRP and E gene) and certain assays “use cutoffs of 40 or even more cycles.” I’m no expert, but I wondered: Shouldn’t they have a constant Ct—because changing it can dramatically change the number of positives? It also makes me wonder that if BC uses a Ct of 35 and Ontario (whose Ct, I’m told, is set at 38) then can this alone explain why BC has a much lower level of positive cases? If some countries set the Ct at 20 (very low) and others set it at 40 (absurdly high), how can one even compare levels of positivity between jurisdictions? This really matters. I consulted a molecular biologist (who asked me to withhold her name as she works as a provincial government biologist) who said that we have to be very cautious in interpreting these tests because the reverse transcriptase enzyme has poor efficiency in converting RNA to DNA. She told me that if we do over 30 to 35 cycles “we can’t culture a live virus from the sample.” Basically, she added, “a high cycle threshold means we’re finding meaningless fragments that say nothing about the infectivity of the patient.” This is an expert who uses the RT-PCR test everyday in her work doing forensic science, so I trust she knows its limitations. She was quite forthright in saying that possibly as many as 90 percent of those testing positive for COVID-19 are probably not infectious. Which is to say they may have had “fragments” of the virus, but they couldn’t possibly spread the virus to anyone else. Is a “positive” test really positive? Where this is heading is a dangerous level of overdiagnosis. Other commentators have said the rate of false positives might be 50-80 percent. More testing and more false positives would help explain why deaths and hospitalizations aren’t rising on the same trajectory. It’s because some new “cases” are unlikely infectious or indicative of ill health. Again a “positive test” is about declaring a person “infected and infectious” but what follows from that? If we were to say maybe half of those 11,000 people in BC testing “positive”—and therefore have been subject to quarantines, social isolation and stigma—then that’s an awful lot of people who have been unfairly labelled and isolated with a disease they couldn’t possibly transfer to others. Maybe this comes down to a question of what we value. Is it better to have a non-sick person incorrectly labelled as sick (a false positive) than to have a sick person labelled as not sick (a false negative)? I can understand the BC CDC’s position, because it’s based on the greatest fear of all, the boogeyman of underdiagnosis. The CDC spokesperson explained it to me this way: “setting the detection threshold too low seems appealing until one misses that early case that can transmit infections to multiple people.” The implication here: we can’t be too careful. However, with screening people for disease you will always have overdiagnosis and underdiagnosis, and careful testing tries to eliminate the possibilities of both false positives and false negatives. It would seem to me that we are likely doing a serious disservice—to society and our economy—by interpreting a test in a way that labels people as sick and infectious when they may be neither. Alan Cassels is a drug policy researcher and author in Victoria. He is the author of Seeking Sickness: Medical Screening and the Misguided Hunt for Disease.
  6. Posted September 28, 2020 Image: Mask wearing in crowded spaces has become the norm. Mask or no mask? It depends...Go to story
  7. The science is thin whereas the symbolism is strong. ONE OF THE MORE FASCINATING THINGS that COVID-19 has brought us is a lot of pandemic-related discourse around masks. Wearing a mask seems like a fairly simple, non-invasive and inexpensive intervention to prevent the spread of a virus. Yet the virulence of arguments made on both sides of the issue is so forceful, and, at times, self-confident, it’s worth digging into the evidence to see what lessons we might find partly because I am a firm believer in the adage that all technology bites back. I’ll wear a mask when I’m sanding, or when exposed to smoke or dust during a renovation, or when I need to conceal my identity, such as at a costume party or when robbing a bank. Wearing a mask in a crowded place, like a store or a train, while the coronavirus still circulates seems reasonable. Yet in Victoria you see people wearing masks walking alone down the street, riding a bicycle, or even driving alone in a car. Sheesh. Even if there is some theoretical benefit to masking up in some situations, in the process have we lost our common sense? Like many things related to healthcare we think that if a little of something is good, then a lot is better. And we’re probably being misled. Wearing a mask in a crowded space during the pandemic seems reasonable. But is there evidence that it makes a difference? Weakness of the evidence base An alert Focus reader from Duncan sent us links to a handful of studies asserting the case that “mandating masks has not kept death rates down anywhere.” The 15 studies he used to support this provocative statement examined health professionals in medical settings over about a 45-year period and he claimed the results have been consistent: “masks are useless in preventing the spread of disease and, if anything, are unsanitary objects that themselves spread bacteria and viruses.” Often in medicine, reasonable-sounding recommendations, when poked, reveal an evidence base that is weak or non-existent. A review of the literature from 2015 of mask wearing in surgery confirmed that there’s very little evidence that “facemasks protect either patient or surgeon from infectious contamination.” Just last month researchers Tom Jefferson and Carl Heneghan at the Centre for Evidence Based Medicine in Oxford wrote that in the past three months there have been 15 evidence reviews on masks, but there is still not a single published trial on the effectiveness of masks for COVID-19. Let’s not forget that lack of evidence for effectiveness does not mean the contrary is true, that there is evidence for their ineffectiveness. What seems most true is that we simply don’t know. Is it possible to extrapolate from other situations, such as studying the spread of other infectious agents, such as the flu virus? In May, an article from the US Centres for Disease Control and Prevention looked at 14 randomized trials of non-drug measures to prevent the spread of the flu. Focusing just on face masks, they found 10 randomized trials of the effects of masks in reducing flu virus infections in the community and found “no significant reduction in influenza transmission with the use of face masks.” Shifting public health recommendations Earlier in the pandemic, the World Health Organization (WHO) reflected this evidence base, saying that “there is no direct evidence (from studies on COVID-19 and in healthy people in the community) on the effectiveness of universal masking of healthy people in the community to prevent infection with respiratory viruses, including COVID-19.” The WHO went on to state that since the community prevalence of COVID-19 is so low (such as here on Vancouver Island) “even if facemasks are assumed to be effective, the difference in infection rates between using facemasks and not using facemasks would be small.” The numbers, if true, are startling: “Assuming that 20 percent of people infectious with SARS-CoV-2 do not have symptoms, and assuming a risk reduction of 40 percent for wearing facemasks, 200,000 people would need to wear facemasks to prevent one new infection per week in the current epidemiological situation.” Even when the evidence case in support of masking shows a pretty small yield, the battle for and against mask wearing remains strong. Spend any time on social media and you’re sure to ingest a powerful dose of pro and anti-mask sentiment. Sidestepping the most vociferous of conspiracy theories, you’ll find those vigorously opposed to lockdowns and physical distancing measures are apoplectic about mandatory mask orders. On the other hand, people in Victoria, whether driven by fear, altruism or simply enacting the spirit of “let’s do what Bonnie asks” can be spotted masked up in the most preposterous of low-risk situations (such as being alone in a car). You can’t overlook the symbolism of masks, the wearing of which can be like a talisman, assert virtue and personal support for “doing whatever” to flatten the curve. Alternatively, not wearing one asserts the opposite: that no one is going to restrict my god-given freedom to do whatever the hell I like. Stanford scientists on COVID-19 mask guidelines Things began to shift in June when the WHO revised their guidelines, after apparently reviewing new information from researchers at Stanford and elsewhere. Claiming that wearing cloth coverings over nose and mouth can prevent the spread of the virus, the WHO guidelines shifted to say that when in close contact with others in crowded areas, with people over 60 or those with underlying health conditions, people should wear medical masks, such as surgical masks, in public. This recommendation might pass the test of common sense, noting that masks are just another form of “source control” to prevent the spread of respiratory droplets from infected people. Yet are there any harms in mandating masks? The Stanford researchers quickly discounted a number of arguments put forth that mask wearing can be harmful—curiously presenting no research to support that position—and concluded with a boilerplate platitude: as societies open up more, we need to protect vulnerable people around us and therefore it’s our duty to do what we can. What if we are all wrong about masks? One of the arguments against masks says that wearing face masks can adversely affect attitudes towards social distancing. Which is to say you’re more comfortable sitting or standing closer to someone else when wearing a mask, a case of risk compensation, similar to the argument that people wearing seat belts are more likely to drive recklessly. Certainly people with respiratory problems like asthma can find mask-wearing very problematic. Then there is the bigger picture about the virus and what is the ultimate effect of hand washing, social isolation and masking policies. Increasingly there is more heft in the discussion of herd immunity, absent a vaccine, and that we’re never going to get through the pandemic until enough of us have been exposed and developed some immunity. Others wonder how high the herd immunity threshold must be before we all basically develop some level of natural protection from the virus. It’s the most crucial unanswered question in this whole pandemic thing. Let’s say herd immunity is at 20 percent. That means about 1 in 5 people are immune. If it was this low, the number of people infected would just keep going down. The problem, of course, is that we have no idea where that number is, and whether, ultimately, all our efforts at social distancing and wearing masks are going to make a whit of difference. Then there is the big question of how long immunity lasts once people have been exposed to COVID-19 and developed some antibodies. No one knows how long antibodies last or how “protected” one is by previous exposure. We think that wearing a mask is protecting our loved ones, but we may be doing so with a price—prolonging the amount of time we’ll need to get to the other side of this pandemic. At the end of the day, no one would argue against an urgent need for scientists to deeply understand COVID-19 and herd immunity before we go overboard with more stringent mask-wearing public policies. Heneghan and Jefferson of the Centre for Evidence Based Medicine in Oxford also write that “masks are a symbol for society—[implying that] you are protected. The evidence says you may not be.” They conclude that in this kind of uncertainty, society has a deep responsibility to study the use of masks thoroughly. This can happen a number of ways, especially by examining the many “natural experiments” in different mask and distancing policies around the globe. The key is to refuse to jump to premature conclusions such as that tighter masking policies are nothing but beneficial. Only when public health officials are brave and willing to have their preconceptions challenged, can society arrive at a truer understanding of what behaviours are beneficial and which are harmful. Masking might seem like common sense for many people and only time and good research will uncover whether we are being mislead. Alan Cassels is a drug policy researcher and lives in Victoria.
  8. Posted August 10, 2020 As many people stop seeking medical help during the pandemic out of fear of catching the virus, fewer people may die as the result of adverse drug reactions to prescription medicine. Go to story
  9. Many people have stopped seeking medical attention during the pandemic out of fear of catching the virus at a doctor's office or clinic. As a result, fewer people may die from adverse drug reactions to prescription medicine. WHEN YOU WITHHOLD MEDICINE, people die, right? Well, not quite. We are currently living in a massive medical experiment that may reveal a number of surprises. Down the road, as researchers look back and parse through what happened in the year 2020, they will undoubtedly discover a goldmine of evidence of the impact of the pandemic—both the good and the bad. We know that things won’t be the same in many dimensions of our lives, and we may discover things that make us fundamentally rethink much of what we do in medicine. Despite all the hardship, anxiety, and economic impact inflicted on the world by the COVID pandemic, there may be some silver linings. One particular area of interest is the ceasing of the delivery of medical interventions. Undoubtedly many types of harm have been inflicted by imposed lockdowns, shutting hospital beds, cutting off of elective surgeries, isolating elderly people from their loved ones, and the general heightened level of fear imposed by social distancing rules. The fact that people have been generally fearful of going near any doctor or health facility may have prevented them from accessing important healthcare. At the same time, not going to the doctor on a massive scale will allow researchers to examine the full effects of stopping medical delivery and possibly uncover unexpected benefits. This is not the first time stopping medical delivery has been studied. Much has been studied about the impact of doctor strikes over the last 40 years, and the results generally point in the same direction: when doctors strike, fewer people die. A systematic review of five doctor strikes between 1976 and 2012 found that patient mortality either stayed the same or fell. It didn’t—as one might expect—increase. How does one explain this? One of the key answers is iatrogenesis, which is harm that is inflicted by the medical system itself—so that any medical activity, including tests, drugs, scans, and hospital stays, can involve harm. Less contact with the medical system, less avoidable death. At least that’s the theory. Currently there are many voices delivering dire warnings about the pandemic’s effects on the health of the population, beyond the risk of the virus. Other voices, perhaps more muted, include some who suggest there could even be some general health improvements. I talked to my friend Dr Eddy Lang, an emergency room physician from Calgary and a member of the Canadian Task Force on Preventive Health Care. He told me: “Some signals are suggesting increased mortality in countries hard hit by the virus, but it is unclear if this is uncounted COVID deaths or collateral damage, as others claim.” We know that, for example, during doctor strikes the kinds of hospital infections and other complications associated with surgery go way down. Some patients who might have mild heart conditions will avoid the hospital, where they may avoid the stent or other bypass surgery they’d get in normal times. This might be a good thing as there is some evidence that we are doing too many of these cardiac interventions in low-risk patients. In mid-July Dr Lang and colleagues published a piece in the British Medical Journal which echoed these thoughts and called for rigorous studies to investigate the effects of reduced healthcare. It noted that “looking beyond the crisis, our collective learning about the effects of the large falls in healthcare use can help inform and intensify efforts to reduce unnecessary care. This in turn can prevent avoidable harm to patients, enhance healthcare equity, and improve the sustainability of health systems everywhere.” What about drugs? If reductions in physician office visits mean that patients aren’t getting new prescriptions, or renewals of existing prescriptions, three things could happen: Their health may worsen, it may stay the same, or, possibly, it might improve. In those serious cases, such as when a person with asthma avoids getting a puffer prescription refilled or a diabetes patient avoids renewing their insulin prescription—this kind of avoidance could turn fatal. But for many conditions, a drug holiday might be very good for you. Dr Lang reminded me that many prescriptions for antibiotics, for example, are unneeded and often cause more harm than good. For longer-term drug use, people who take drugs in a class called proton pump inhibitors (PPIs) including Losec, Pariet, or Pantaloc, which are prescribed mostly for heartburn, might see their health improve if they slowly weaned themselves off the pills. A study published last year examined over 200,000 US veterans who took PPIs and found that long-term therapy with these drugs, with other things being equal, increases the risk of death. Adverse drug reactions (ADRs) associated with many commonly used prescriptions, are a real thing. As well, as Dr Lang points out: “The trials that looked at these drugs actively avoided recruiting frail folks with co-morbidities.” What this means is that older and more frail people are likely at even more risk. Being injured or hospitalized because of a medication reaction is commonplace and some estimates say as many as 220,000 Canadians suffer ADRs per year in Canada, of which about 10 percent, or 22,000, are fatal. “Not to mention the thousands of avoidable hospitalizations,” adds Dr Lang. Obviously if the harm exceeds the benefit of any medication, stopping it might be the right and healthy thing to do. ADRs are often overlooked and underreported, but if you broke down the estimated ADRS by province, BC alone would have about 2,860 ADR deaths per year, or about 8 deaths per day due to what are regular, normal prescribed drugs. As of mid-July in BC, we’ve had about 190 COVID deaths in the last 120 days, or about 1.5 per day. So you could look at it this way: If people stopped taking drugs that were causing excessive ADRs, that act alone could potentially save up to five times more lives than we are losing to the virus. In the future, stopping certain medications could be a lot more “normal” than it currently is. Some of the major chronic conditions like high cholesterol, type 2 diabetes or high blood pressure, result in a lot of long-term drug use, but probably not as much as you’d think. Many people naturally stop taking their drugs for whatever reason, or get to the point where they’d rather not live with the hassle or expense. Drugs for type 2 diabetes are almost universally prescribed to alter blood sugars, yet for most people any change in your numbers brought on by these drugs don’t automatically translate into a longer or healthier life. Even the guidelines (which are underwritten by the drug industry) advise that the most important step in helping type 2 diabetics is altering diet and exercise patterns—before you ever consider taking a drug. But what about high blood pressure? Stopping medications has always been difficult because clinicians and patients worry that stopping a drug will worsen their health. But what about drugs for high blood pressure? Well, even here there is growing evidence that stopping antihypertensive drugs (drugs to lower blood pressure) may not be bad for you, especially if you’ve never had a heart attack and are not afflicted by cardiac issues. Dr Lang reminds me that “elders have a higher risk of ADRs and may not benefit at all from a lower blood pressure.” A recent systematic review by Cochrane agreed with him. It looked at six studies with over 1000 healthy patients over 50 and found that those who stopped their high blood pressure pills did as well (in terms of heart attacks and deaths) as those who continued. This review was rated as “low certainty” of evidence, so it is not the last word on the question. What it did show is that there is no evidence of increased risk if older people without established heart disease stop taking their antihypertensive medications. The implications of this itself could be huge. Let’s not downplay the seriousness of hypertension, which is considered a risk factor for strokes, heart attacks, and chronic kidney disease. At the same time, you would only want to be taking these drugs if you were sure they are reducing your overall risks, instead of just altering your numbers. But as Eddy Lang notes: “Knowing for sure is almost impossible. Best you could hope for is a decent chance of benefit.” In any event, it’s certainly worth a discussion with your doctor. Stopping medications, for older people who face the many problems that often come with too many drugs, is becoming more and more mainstream. There are a number of groups who are actively concerned with overprescribing and working to reduce the harm of too much medicine.The Canadian Deprescribing Network, and Choosing Wisely Canada are two such organizations. As a researcher I’m particularly hopeful that this pandemic will prove to be an opportunity to discover which medical treatments or drugs we could use less of. It’s a natural experiment that is happening around the world. With some good international collaboration and good data on how we have faired with less medicine and less medication, we might learn some valuable lessons. Alan Cassels lives in Victoria where he studies and writes about pharmaceuticals. He works for UBC but the opinions represented here are his own.
  10. ...working on it.... Did you know there are over 500 trials registered with the USFDA that are recruiting patients for COVID-19 trials? Most of those are drug trials and so the race for treatments has never been this intense.
  11. Posted June 9, 2020 Photo: Healthcare worker administering a vaccine. Vaccines often seem to be in their own special, sacred category of pharmaceuticals, yet the science is often far from settled. Go to story
  12. Vaccines often seem to be in their own special, sacred category of pharmaceuticals, yet the science is often far from settled. THERE’S NEVER BEEN A VACCINE FOR A HUMAN CORONAVIRUS and yet a vaccine for SARS-CoV-2 seems to be the holy grail we’re all waiting for. If so, we could be in for a very long wait. Vaccine development is tricky and the kind of immunity that most would find acceptable—protecting against excess deaths and sickness—may never be achieved. There has never been an effective vaccine for a coronavirus, so to think we’ll develop one within 12-18 months, as experts are saying, seems farfetched. Any shortcuts taken to approve a vaccine may compromise safety and effectiveness for speed. We may all hope and pray for a vaccine, but it would be most preferable if we had a vaccine that worked. And it’s worth noting, that all technology bites back. Sometimes fatally. Before the pandemic, a friend, an expert who is writing a book on vaccine safety, thought I might have some thoughts on where we are going on vaccines and whether vaccine mandates might be used. He sent me a list of questions, which I answered and now have adjusted in light of COVID-19. 1. What have you learned about vaccines, their effectiveness against infectious diseases, and the risks they might pose for some individuals? I have learned a lot from the scientific literature and working with colleagues who study the safety of drugs. In the drug world, often experts will assert the “facts” of a drug’s safety are solid and unassailable, but we later find out we were mislead. In fact, if I had one universal thing to say it would be that expressing certitude concerning effectiveness or safety of a drug or vaccine is a naïve position. Those who are honest about the science will often say that proper and unbiased research to establish a true picture of safety is often not done. People need some level of comfort that they are making the right choices for themselves or their children. In this vein, the benefits of the six basic childhood vaccines (combined in the DPT—diphtheria, pertussis, and tetanus—and MMR—measles, mumps, rubella—vaccines) likely exceed the harms and can improve population health. Have some people been harmed by these vaccines? Yes. It’s very unhelpful to label people who have legitimate concerns about vaccine harms as “anti-vaxx” and disregard them. It is delusional to think vaccines only have benefits and no harms. 2. Do you believe vaccines are an important component of modern medicine? Please provide examples to illustrate your opinion. Nobody would ever say all drugs are important, but many will claim that “all vaccines are important.” For some vaccines, it’s not yet established if they are important or not. Asking people to “vote” on whether they’d get a COVID-19 vaccine (if it is ever produced) is stupid. Like any drug, the right answer is, it depends. On my list of “possibly useless” or “not yet proven to be beneficial” vaccines, I’d put shots for rotavirus, pneumonia, flu, chicken pox and HPV (human papilloma virus). Some people might benefit from a flu shot, but in a healthy population the benefit is vanishingly small. Despite the hype over the HPV, the first mass vaccination to prevent cervical cancer, it hasn’t shown any lifesaving benefits yet. And chicken pox? Meh. Most kids challenged by chicken pox will have a few days off school and be rewarded with lifetime immunity. Not a bad deal, huh? 3. Do you have concerns about vaccine adverse effects? Which ones in particular, if any? Indeed. For some vaccines we don’t know the magnitude of adverse effects, the type of person who might be at higher risk if immunized, whether the recommended vaccine schedule itself causes adverse effects, or even if medically-trained people can properly diagnose a vaccine-related adverse effect. Rare yet nasty immune-system harms have been linked to some vaccines. There are several medical clinics in Europe designed to help girls suffering the adverse effects of the HPV vaccine. Have these families cooked up a conspiracy against HPV vaccine manufacturers? Unlikely. Again, labelling vaccine-injured people as “anti-vaxx” isn’t helpful. It’s a much more mature conversation if you can accept that people are sometimes helped and sometimes hurt by vaccines. 4. Do you feel that on this subject the science is settled? Do you feel that the same claim can be made about any other branch of science or hypothesis/theory? No. No. No. Nothing is settled. Proclaiming “the science is settled” on the usefulness and safety of vaccines is the biggest barrier to producing quality, independent science. The scrutiny of any COVID-19 vaccine is going to be intense and before any mass immunization plans come together we need solid proof the real benefits exceed the harms. This may come as a shock to people but many prescription drugs swallowed by millions of us every day are either not proven in quality trials, have proof of harm, or haven’t been proven either way. A Health Canada stamp of approval is no guarantee that we can fully trust the science underlying that approval. Scientific debates over the value of some drugs and some vaccines are frequently “unsettled” and, frankly, unsettling. 5. What do you feel the role of the pharmaceutical industry is, if any, in controlling the discussion about vaccines in general? Like any big business or monopoly industry, the goal is to maintain and increase shareholder value. Pharma companies, which make both drugs and vaccines, have only one main legal requirement: to maximize shareholder value. Over the last 25 years I have seen how the pharmaceutical industry has used its prestige, power and financial might to purchase a central role in the practice of medicine. It holds inordinate power over how we think about sickness and medicine, a kind of “cultural hegemony” where the beliefs and explanations, perceptions, values and mores of a society have been imposed by a ruling class manipulating the culture of that society (rephrased from Wikipedia). Let’s be clear about one thing: The drug industry doesn’t just manufacture products, it manufactures consent about its products. Can our public health people work in a healthy alliance with the hegemony of the pharmaceutical industry? Will trustworthy, independent, evidence-based assessments of a new COVID-19 vaccine prevail? In our haste for a vaccine will we continue to live in this strange dual world where many of us are deeply and appropriately skeptical of the pharmaceutical industry’s hegemonic power in medicine, yet somehow blindly believe that vaccines are in a special, sacred category? 6. What is your opinion about the need for “vaccine mandates”? Why? Mandates are about forcing people to accept a medical treatment when they may not want it, for whatever reason. They are seen as a way to put pressure on vaccine-hesitant people, through regulations and laws. Problem is, mandates can be ineffective because they are likely to backfire. Mandating the injection of a chemical into someone’s body is unlikely to achieve the objective of increased immunization rates. Thankfully Dr Bonnie Henry, our Provincial Health Officer, doesn’t think a mandate is necessary. She told CTV news “we have no mandatory immunization in the province and I do not expect we will have mandatory COVID-19 immunization.” 7. Do you have any concerns about such mandates for civil or natural rights? Absolutely I’m concerned about legislating vaccines. The biggest problem with forced vaccines is that Canada has no compensation system for people who are vaccine-injured. Would it be good policy to order everyone to drive a car but tell them they can’t buy car insurance? If you are injured and medically damaged for the rest of your life, tough luck. Too bad sucker. You’re on your own. I would be very concerned if our politicians relied on a hastily developed and launched COVID-19 vaccine policy that could ultimately harm people. What if it produces antibodies but people get sick anyways? Or worse, healthy people become injured by a vaccine designed to help them? Lockdowns might drive people crazy, but an uninformed public might push hard for a mandatory immunization policy. Before even thinking of a mandate, public health people will need hard evidence that there is a vaccine that is rigorously scrutinized, proven effective and safe. This is a very, very tall order… Alan Cassels is a pharmaceutical policy researcher and lives in Victoria.
  13. May 15, 2020 Photo: Psychiatric drug expert Kim Witczak Media messaging that there’s a mental health epidemic could indeed lead to one—and cause other health problems. Go to story
  14. FIFTEEN YEARS AGO while writing our book Selling Sickness, Ray Moynihan and I probed deeply into the pharmaceutical industry’s involvement in the development and marketing of a little known condition called “social phobia.” Apparently, some people are so nervous in social situations that they rarely leave their house. Public speaking? Definitely out of the question for social phobics. While the extreme form of that condition could certainly be debilitating for some, with the financial might of one of the world’s biggest pharmaceutical companies, and the FDA approval for paroxetine (Paxil) to treat this new condition, “social anxiety disorder” (SAD) became a multi-billion dollar market almost overnight. With some of the slickest, award-winning drug marketing ever seen, the poster tagline behind Paxil read: “Imagine being allergic to people.” The ad didn’t even mention the name of the drug. Why? Because they were just marketing the condition, and they had (at that time) the only pill approved to treat it. The whole fascinating tale, complete with celebrity spokespeople, athletes on the payroll, and fake patient groups promoting the disease, was textbook bamboozlement, selling consumers and prescribers a company-sponsored version of “abnormal” mental health. Enter the pandemic, an unprecedented time of worry, where stress, fear and anxiety among a locked-down population become the perfect petri dish to spawn new customers of psychiatric drugs of all sorts. A report from the US pharmacy management company Express Scripts said that the number of prescriptions filled per week for antidepressant, anti-anxiety and anti-insomnia medications “increased 21 percent between February 16 and March 15.” The kicker here? Three quarters of these were for new prescriptions. The Council for Evidence-Based Psychiatry (CEP) in the UK reported that 20 percent of the adult population in the UK were taking antidepressants. They are worried that “reframing situational distress as a psychiatric condition” could lead to speculative, pre-emptive prescribing. That is, getting a script “just in case.” Suffice to say a whole lot more of us might be coping with their lock-down situation with the help of a new drug, an adventure that may not end when the pandemic has run its course. If you’re anxious, does that mean you’re sick? There are many things wrong with this picture. First of all, feeling anxious towards situations out of one’s control is normal. Feeling a sense of loss and worry given the rapid way in which society is being reshaped by the pandemic? Also normal. People need social interaction and the support of their families and peers, something which social distancing makes more difficult. Yet a pharmaceutical lifebuoy may not be the answer for most. The history of “selling” depression, which put generations of people on antidepressants, is built on a false narrative of “chemical imbalance” where wonky brain chemistry is blamed for your sorrow and thus tweaking your neurotransmitters fixes it. If it were only so simple. Today, most thoughtful psychiatrists have largely discarded the chemical imbalance theory, yet patients come to them for chemical help. Undoubtedly media saturation, and the infodemic of minute-by-minute death numbers due to COVID-19, adds to the stress of pandemic-induced isolation and disruption. Media reports claiming we’ve got a full blown “mental health crisis” on our hands—whether true or not—likely means that careful and cautious prescribing gives way to an epidemic of people taking antidepressants and anti-anxiety drugs. KIM WITCZAK BECAME A FIERCE DRUG SAFETY ADVOCATE 15 years ago, after her husband Woody took his own life after being prescribed Zoloft, a widely-prescribed SSRI antidepressant (this class of drugs include Prozac and Paxil). Well-versed on the dangers of antidepressants, Kim is one of the most coherent voices on the dangers of psychiatric drugs and sits as a patient representative on the US FDA’s Psychopharmacologic Advisory Committee. Advocates like Witczak have influenced regulators about drug warnings and in fact her testimony and others in front of the FDA on the risk of suicide related to SSRI depressants forced the US FDA to put black box warnings on those drugs. (See www.woodymatters.com) Kim Witczak I contacted her at her home in Minneapolis to talk about the impact of COVID on mental health. “So many lives have been greatly damaged or impacted by the economic toll on families,” she said, adding, “drugs are going to be thrown at people.” “People need to be informed…Pills are not a quick fix, but I fear they will be the easiest way to deal with mass mental health issues of society,” said Witczak. What adds fuel to this fire is the fact that telemedicine in both Canada and the US are loosening the requirements and making it a lot easier to prescribe a range of drugs. Witczak is concerned that many patients aren’t going to have needed conversations around the immediate and long-term harms including addition and withdrawal effects related to psychiatric drugs. “These are serious, mind-altering drugs that have real risks,” she told me. “It is normal to be struggling with intense emotions like anxiety, fear, sadness, anger given this global pandemic and no one having a clue what the future holds. But is it really mental illness? People should pause and think twice before quickly resorting to a pill.” There are effective alternatives to drugs including counselling, cognitive behavioural therapy, mindfulness-based stress reduction and “exposure therapy” which can effectively reduce anxiety without the potential problems that come with any drug. The normal advice about reducing stress applies even more: getting exercise, eating properly and getting out into nature. My lay advice would add one thing: stop squirrelling away with social media or reading the news all the time. The world might be crazy but you don’t have to be. Some people are questioning this premise that we’re facing a massive mental health crisis and noting that there is a flip side to all of this. George Monbiot, writing in the UK’s Guardian, noted that the pandemic is causing a global outpouring of community action—people getting to know and look after their elderly neighbours, volunteers delivering food for healthcare workers and first responders, kids building healthcare visors on their home 3D printers and so on. Maybe the inherent altruism of people is emerging as a way to deal with the pandemic’s stresses? But back to the selling of social anxiety. In surveys people often say they fear public speaking more than they fear death. But is being afraid of speaking in public a “disease?” Is the fear of death? Maybe imagining the worse makes us all eager to reach for any lifebuoy at hand. But for those of us who are well aware of the dangers of prescription drugs, we just want to make sure that what keeps you afloat is buoyant, and not another anchor. At the end of the day it’s OK to feel anxious. Our world is changing. What would be really bad is if the short-term solutions turn into much worse long-term problems. Alan Cassels studies pharmaceutical policy and works at UBC. His book Seeking Sickness: Medical Screening and the Misguided Hunt for Diseases is available from bookstores and libraries. You can follow him on twitter @akecassels.
  15. March 5, 2020 Thoughts around overdiagnosis after a visit to a medical specialist. A FASCINATING STUDY was published last month in Australia. It may not have got much press here in Victoria, but confirmed a lot of what the world is learning about overdiagnosis. That study, carried out by Paul Glasziou and colleagues, compared the year 1982 to 2012, analyzing changes in lifetime risks for prostate, breast, renal, thyroid cancers and melanoma. They concluded that 18 percent of all cancers diagnosed in Australian women (11,000 diagnoses each year), and 24 percent of those in men (18,000 each year) are overdiagnosed cancers. Screening programs (for cancers and other things) look for signs of disease detected in healthy people. Often those signs are just “prediseases,” benign signs which never go on to be lethal. Predisease is what might be diagnosed when a screening result isn’t quite normal, but is below the threshold of true disease. It is considered a potential precursor to a disease which may or may not be worrisome. The seriousness of “false positives” is also gaining worldwide attention, as this Australian study demonstrated. I wrote about the problems of overdiagnosis in my 2012 book Seeking Sickness and made the same case, where in condition after condition which involves some kind of medical screening, there is always overdiagnosis. There’s both benefits and harm in screening healthy people. It’s worthwhile if it finds signs of potential disease that will stop you getting a more serious disease. It can, however, lead to anxiety and often substantial medical activity, including biopsies, more screening, more procedures, surgery, radiation, and prescription drugs. Often all this anxiety and medical activity never actually extends the quality or quantity of your life. Here’s a scene that happened when I was partway through writing that book: I am in the chair at the optometrist, as he was about to blow a puff of air into my eyeball, checking for eyeball pressure. It dawned on me: “This is a screening test!” This is how I described it: “Things look different when you’re sitting in the chair, playing the role of the trusting patient. It was like I had two angels sitting on my shoulders. One was whispering in one ear: ‘What’s the big deal? It was just a puff of air to the eyes. C’mon.” On the other shoulder, the naysayer angel, armed with a pitchfork, was jabbing me in the ear: “Are you nuts? Do you have any idea what this screening test will lead to? False positives. False negatives. Overdiagnosis. Downstream effects. Worry. Anxiety. Depression. Say no!’” I was being overdramatic, yet I wrote that I learned a vital lesson: if you are about to face a health professional offering you a screening test, you need to have already done your research. Doing it afterward is getting things backward. The air-puff test showed normal eye pressure, but what if it didn’t? Thankfully, I didn’t find out. That experience became my operating axiom of why people need to go into medical screening test with their “eyes wide open.” Fast-forward eight years, and it was time for another trip to the optometrist. To get my eyes checked, maybe see if I needed a new eyeglass prescription. But darned if this didn’t turn out to be another “teachable moment,” this time with a much more potentially serious intervention. My optometrist said he saw something unusual in one of my eyes. He said I had a suspected case of narrow-angle glaucoma, a condition that could lead to an acute eye emergency and the potential loss of sight. That opened my eyes. He referred me to an ophthalmologist. The first trip to the ophthalmologist was just for a few tests and pictures of my eyes, collecting data. I was invited to watch a video of the doctor explaining the procedure he would offer, a quick operation called a laser peripheral iridotomy (LPI). Perfectly safe, right? But… Let’s be clear. I am a healthy patient, normal eyeball pressure, and a normal optic nerve. No history of eye disease and no family history either. I was what the literature called a PACS, which stands for “primary angle closure suspect.” I don’t have disease—I have the younger sister, predisease. I found an excellent paper by Dr H. George Tanaka, an ophthalmologist in Arkansas whose 2018 Review of Ophthalmology study gives considerable detail about the pros and cons of such a procedure. I learned quickly this was no slam-dunk, and I was right to be cautious. I tracked him down and arranged a phone interview. The main thing I learned is that for people without symptoms or family history of other types of eye diseases, there is no way to know how many PACS patients go on to have an “acute episode” that involves losing your eyesight. Is it one in ten, or one in ten thousand? We don’t know. He admitted that “unfortunately, we don’t have any good evidence for how to manage a PACS patient, and that we don’t know how many PACS patients go on to develop more serious eye problems.” For the sake of everyone in Victoria who (at a certain age) may well be diagnosed with suspected angle-closure glaucoma, there are a few things to know about the LPI surgery being offered. Angle- closure glaucoma can be an aggressive disease, probably the leading cause of glaucoma blindness in the world, and it is one of the few emergencies in ophthalmology. But as Dr Tanaka wrote: “We don’t actually know how many future angle-closure attacks we’re preventing by performing LPIs. That’s why we can’t say to a patient with narrow angles, ‘Mrs Smith, your risk of going blind is X percent (or your risk of getting glaucoma is Y percent), but the odds will improve by this much if I perform this procedure.’ We don’t have the numbers to support that.” It’s the conclusion that bothers me: “so we just treat everybody.” Clearly, this is textbook overdiagnosis: finding “predisease” in normal people, who are then given the impression they are now living under a dark cloud. The research suggests the LPI may delay or prevent primary-angle glaucoma. Luckily, the LPI is fairly benign. This operation used to be major surgery, but now is a couple of minutes in the clinic, with minimal risks of infection or bleeding. As for the cons, sometimes things go sideways. Sometimes patients get extra spots of light in their vision—dysphotopsias—which won’t go away. And believe it or not, some research says the LPI can accelerate cataract development, as well as make you more predisposed to getting a condition called posterior synechiae, making future cataract surgery more difficult. For me, saying no to the procedure was a no-brainer. If I had higher risks, a personal or family history of eye disease, high eyeball pressure, or if I was going to be hiking in the outback for months at a time where getting emergency medical care was difficult, my decision might have been different. But the doc was not impressed. I really liked the ophthalmologist. He was a very nice gentleman. He explained things well, but at the same time, I could tell he was taken aback when I refused the procedure. Perhaps he’s not used to patients doing a deep dive into the literature on the potential benefits and harms of surgical procedures. He pressed me, eventually turning up his hands and saying: “Oh well, I just want to tell you the risks, but you’re on your own,” later adding, “well, you’re the ticking time bomb.” Luckily I have a thick skin, though if you had taken my blood pressure at the time it, would have been through the roof. Not only does his comment not reflect the real research, it’s the height of insensitivity to call a patient a “ticking time bomb.” No one deserves to be intentionally frightened into getting an elective procedure, especially one with many unknowns and potential harms. As an aside, if the average person knew how much these doctors make by five minutes of lasering your eyes, they would be astounded (all in, close to $400 per eye—$116.76 for the actual few minutes of surgery, $35 for the office visit, $96 for the consultation, $60.42 for “orthooptic evaluation,” with likely extra charges for the photography of the eyes, etc. ). I found in the MSP bluebook that this ophthalmologist billed MSP $749,000 last year. Later, when I calmed down, I reflected on the “ticking time bomb” comment. Listen, dear reader. Like everyone on the planet, you could live another five minutes or another fifty years. We are all ticking time bombs, more or less. We are all “prediseased” and suffering from “predeath.” Being called a “ticking time bomb” made me angry but also sad for all the patients who are worried, who crave the trusted advice of a health professional, but then get bullied into procedures (or drugs) that they would rather not have. When I was in the navy, we had a principle: if you don’t know where you are, stop the ship. All signs of disease have uncertainties, and all surgeries and drugs have potential harms and potential benefits. Any honest health professional will tell you those uncertainties. When you don’t know where you are, don’t keep sailing. Alan Cassels studies pharmaceutical policy and works at UBC. His book Seeking Sickness: Medical Screening and the Misguided Hunt for Diseases is available from bookstores and libraries. You can follow him on twitter @akecassels.
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