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  1. What’s happening in the world of antipsychotics might keep you awake at night. WHY DOES IT SEEM LIKE everyone has an antipsychotic story they want to tell me? For Victoria resident Roedy Green, his troubles hit a peak when he found he couldn’t haul himself out of a bathtub. He felt things had already begun going seriously sideways after a series of falls, then the 71-year-old computer programmer found that he was constantly sleeping—sometimes for up to 20 hours a day—which made Roedy feel like he was losing his grip on life. In addition to starting to feel demented, the final straw was the loss of muscle strength while trying to exit the bathtub. He and his housemate Geneva Hagen began to search for answers. This Victoria pair discovered that in addition to many other pills he was taking to manage his HIV, diabetes and bipolar disorder, Roedy was being prescribed an antipsychotic—supposedly to help him sleep. Ironically, insomnia was one problem that he had never had, and what he needed was to stay more alert. The drug quetiapine (also sold under the brand name Seroquel) is widely used to promote sleep, though that is not an approved use. It is formally approved by Health Canada to treat major depressive disorder, schizophrenia, and episodes of mania associated with bipolar disorder, but is often used in low doses for insomnia. When the doctor asked, “So how are you doing on the Seroquel?” Roedy and Geneva were shocked. They hadn’t realized that a previous visit had resulted in a prescription for this antipsychotic. Apparently doctors at the geriatric clinic had misunderstood his complaint. “With Seroquel he was just a zombie,” Geneva told me. “He was sleeping 18-20 hours a day. He couldn’t get anything done. It was like having a potted plant.” THE INDISCRIMINATE USE OF ANTIPSYCHOTICS is likely one of the biggest pharmaceutical scandals of our time, centred around one of the most expensive and inappropriately used drug classes in modern society. The problems of antipsychotics being used to treat sleep problems have been on the radar of the medical establishment for many years. Even though antipsychotics like quetiapine are not approved to treat insomnia, they are often prescribed for that purpose. Some have blamed the growing use of antipsychotics on the recognition that other pills used for sleeping and anxiety—the benzodiazepines—are addictive and, over time, ineffective, but that is only part of the explanation. What often comes up is the issue of “management” in long-term care. People with dementia can often become agitated and aggressive, and therefore antipsychotics seem helpful, especially in dealing with someone who can be physically abusive to staff or other residents. In low doses, antipsychotics can be very sedating. Plus they come with a whole host of adverse effects, including a kind of unpleasant agitated restlessness called akathisia, and tardive dyskinesia, quirky movements and tremors that can be mistaken for Parkinson’s disease. The weight gain and diabetes associated with antipsychotics are also legendary. A Victoria psychiatrist once told me the story of prescribing an antipsychotic to a new patient. By his next visit a month later, the psychiatrist couldn’t recognize the patient, due to the ballooning weight he’d gained. SINCE 2003, there have been many regulatory actions against quetiapine and other “atypical” antipsychotics, which include drugs like olanzapine and risperidone, both in Canada and the US. Warnings from the FDA and Health Canada have included increased risk of diabetes symptoms, of death in elderly people with dementia, increased blood pressure in children and adolescents, arrhythmia (heartbeat rhythm abnormalities), sleep apnea (which can cause breaks in breathing or very shallow breathing during sleep), excessive sleepiness, low blood pressure upon sitting up or standing (postural hypotension), and problems with balance, effects that increase the risk of falls. In 2010, Quetiapine’s manufacturer agreed to pay a US $520 million fine over allegations of promoting off-label (unapproved) uses, such as for anger management, dementia and insomnia. A report commissioned by the BC Ministry of Health in 2011 said that 50.3 percent of all residential care patients in BC “were prescribed an antipsychotic between April 2010 to June 2011.” Since then, this problem has been the subject of numerous reports and guidelines trying to tackle the issue, with limited success. In 2015, the BC Seniors Advocate Isobel Mackenzie identified the continued overuse of antipsychotics and antidepressants in residential care as worrisome, noting that while only four percent of BC seniors in long-term care have a diagnosed psychiatric disorder, 34 percent of them were prescribed antipsychotics. According to the Alzheimer’s Society of Canada, about one-third of Canadian residents in long-term care are prescribed antipsychotic medications, despite the fact that professional geriatric societies have long warned against the use of these drugs in the elderly, especially those with dementia. THE PRESCRIBING OF ANTIPSYCHOTICS is not only controversial but expensive. BC Pharmacare lists quetiapine as the tenth most expensive drug on the Pharmacare formulary, paying over $16 million in 2017/2018 for the drug. Three of the top 20 drugs in BC Pharmacare’s list of most costly drugs are antipsychotics. Nationally, antipsychotics prescribed for non-seniors were the third highest public drug expenditure of all drug classes (fifth highest for seniors). In Canada this drug class consumes about $600 million in annual public expenditure. Last year Mackenzie slammed the Province again for making very little headway in reducing the use of antipsychotic medications in BC’s seniors. While numbers have decreased slightly in recent years, compared to other provinces, she complained that BC had made little headway in 2018. In that year, a quarter of BC seniors living in long-term care were still getting an antipsychotic medication without a supporting diagnosis, which is to say, they may be getting them for off-label uses. Physicians know that the elderly need much more delicate prescribing, partly because as we age, our bodies change, and the ability to metabolize drugs is also reduced. Kidney function often diminishes with age, and without appropriately clearing drugs from your body, drugs can build up in your system, causing other problems. Geneva told me that on the antipsychotic, Roedy became so impaired and disoriented that “we were both worried about dementia.” “What made you think that the problem might be due to the drug?” I asked. Geneva said there were two things: A friend had warned her several months earlier that many local patients are being prescribed Seroquel for sleep, and had advised her to avoid it. When she heard Roedy’s psychiatrist mention Seroquel, she remembered this warning and realized that something was amiss. “The bubble-pack had listed only the generic name quetiapine, but not its purpose,” she said. Questioning that drug and immediately withdrawing it, they both believe, had Roedy back to normal within a few days. His scores on cognitive function tests improved dramatically. “I’m not very social,” says Geneva, “yet since this happened I have had three other people tell me they are regularly using Seroquel for sleep.” She adds that none of those people seem very functional. The stories of patients prescribed drugs, often without awareness of their purpose, are endless, and the concept of “informed consent” seems to not apply. Many of us are too shy to question the safety and appropriateness of what is being prescribed, not wanting to be a prickly patient in a world where primary care doctors are a scarce commodity. As well, many busy physicians may not know, nor have the time to lay out the possible complications of an antipsychotic prescription. But often they’ll respond if asked. The inappropriate use of drugs such as quetiapine could be costing society immensely—not just in cost for the drugs themselves, but also in the rate of falls, broken bones, head injuries, drug-induced diabetes, motor vehicle accidents, and commitments to long-term care facilities. The wrong prescription drugs can be as dangerous as street drugs. But it doesn’t have to be that way. Roedy Green, who was losing his ability to function, was halted in his spiralling downhill by questioning the drugs he was being prescribed. Asking questions and questioning answers can often help change the course of one’s treatment. The medical world is slowly starting to wake up to the dire harms related to antipsychotics, and turning to safer, more effective ways to help people sleep. Doctors know that managing insomnia needs to focus on education and encouraging good sleep hygiene. The other issue too is that maybe our obsession with getting eight hours of uninterrupted sleep every night is downright harmful. Drugs, if needed, should only be used for the shortest possible time in exceptional cases. Now it’s important for patients to insist on this. This is true for antipsychotics, and almost every other drug you may be offered. Alan Cassels is a drug policy researcher and works at UBC.
  2. Psychiatrist Dr Joanna Moncrieff says “often there are better ways to deal with things” than taking drugs. IT IS ONLY AFTER AFEW SECONDS into my conversation with Dr Joanna Moncrieff, a psychiatrist based in London, UK, when her fresh perspective on psychiatry strikes me. “I think mental illnesses are more like aspects of our personality than they are illnesses that come over us. People can struggle with their feelings and behaviour, but usually they can learn ways to manage and deal with them. Sometimes that might involve taking drugs, but often there are better ways to deal with things.” The British psychiatrist is a leading figure in what is known, broadly speaking, as the critical psychiatry movement. As the author of several books including The Myth of the Chemical Cure, Dr Moncrieff is a prominent critic of the modern “psychopharmacological” approach to treating mental health challenges. Dr Joanna Moncrief She is in Vancouver next month as the keynote speaker at a conference for BC physicians and pharmacists, and agreed to speak with me in advance of her trip. Our wide-ranging discussion delved into how society uses an array of psychiatric drugs including antipsychotics, drugs for ADHD, and antidepressants. It is the latter class of drugs—antidepressants—that I want to focus on, particularly because I want to try to understand one simple fact: why are so many of us taking them? A study released this August found that 8.8 percent of Canadians between the ages of 40 and 79 took an antidepressant in the last month. In the US, that number is 15.4 percent. When you tease apart the utilization data on these drugs, you find women are twice as likely as men to be on an antidepressant. In British Columbia, close to 20 percent of women between ages 19 and 55 are taking an antidepressant. Canadian data from 2016 found that 60 percent of seniors in long-term care are on antidepressants (compared with 19 percent of seniors living in the community). With a bit of census data and some quick math, I roughly calculate that in Greater Victoria alone, there are close to 30,000 women under 65 who are taking an antidepressant. Let’s be clear, depression can be serious and debilitating, and there should be no stigma associated with taking an antidepressant or on any drug that is helpful; yet at the same time, these kinds of statistics raise many questions. If one in five women in Victoria are on an antidepressant, why? Is depression really as widespread as the drug stats might indicate? Does this really indicate that a lot of people are medically sick and receiving an effective treatment, or are we medicalizing the ordinary difficulties of life? To be fair, antidepressants are prescribed for a variety of things, including anxiety, obsessive compulsive behaviour, premenstrual symptoms, and panic disorder, among others. But most of their use would likely be linked to persistent sadness and hopelessness. I asked Dr Moncrieff how we arrived at this point. She quickly pointed to a number of factors, particularly that taking mood-altering drugs is not a new phenomenon. For nearly half a century, women especially have been plied with drugs such as benzodiazepines or barbiturates for anxiety and depression. One way to explain this, she said, is that “women might be more likely to internalize their distress. Men are more likely to get angry and drink. Men are likely to blame outwardly.” As for the statistics, she’s as astonished as I am: “It’s extraordinary, isn’t it? It’s an indicator of a number of factors—there are a pool of people whose lives are miserable, who go to the doctor looking for a solution; years ago they would have been put on a benzo, or a barbiturate, and so on.” She noted some people do seek a chemical solution to their problems—but, she added, “this view reflects the huge marketing efforts that happened in the 1990s.” This coincided with the first Selective Serotonin Reuptake Inhibitor (SSRI) type of antidepressant, Prozac, coming into use. In her estimation, when it became apparent that benzodiazepines like Ativan, Valium or Xanax “were being handed out like sweets, that’s when the drug industry came up with this idea of the chemical imbalance, in association with launching the new SSRI antidepressants.” Prozac was followed by other drugs intended to alter serotonin in the brain, like Zoloft, Paxil, Effexor and others. The “chemical imbalance” theory is one of the biggest controversies in psychiatry; it is often hauled out to explain a person’s depressed mood, and how a drug which tweaks the level of serotonin in the brain might actually help. The problem is that there is little, if any, proof to support such a theory. “The evidence for a link between serotonin and mental illness is all over the place,” said Dr Moncrieff. “The idea that psychiatric drugs are tweaking some underlying abnormality is completely misleading,” yet this hasn’t stopped these drugs from becoming the mainstay treatment for depression. The automatic prescribing of antidepressants, in Moncrieff’s opinion, is fraught with problems. “If you tell a person going through depression that they need a drug, you are giving them a message that they are biologically abnormal. Not only are drugs chemicals that interfere with normal biological responses,” she says, “the ‘chemical imbalance’ idea is also disabling. It often ends up with the patient trying one, then another, then another different drug. They just end up being on a cocktail, because none of them actually work,” she said. While some sorts of psychiatric drugs can help some people some of the time, Moncrieff believes other factors are likely leading to society’s over-reliance on antidepressants. As Jiddu Krishnamurti famously said: “It is no measure of health to be well-adjusted to a profoundly sick society.” There is no shortage of adverse societal influences causing many of us to feel anguish and despair. Dr Moncrieff’s UK perspective includes “things such as austerity, following the financial crash in 2008—and a general income drop in the last few years—that has likely created a genuine large amount of distress and misery.” And let’s not forget more recently that her country has been dealing with the deep uncertainty caused by Brexit, undoubtedly adding anxiety to peoples’ lives. While it might be understandable why so many people are initially put on antidepressants, the question arises, how come so many people stay on them for the long haul? Part of this has to do with dependence. As Joanna Moncrieff says, “Some antidepressants are very difficult to get off—many people don’t realize they have withdrawal symptoms. They try to stop, and they think they have a relapse, and it confirms their status as a patient.” Moncrieff agreed the very mention of “withdrawal symptoms” associated with SSRIs is controversial. Earlier this year, a newsletter produced for BC doctors and pharmacists by the Therapeutics Initiative was attacked by a vocal Vancouver psychiatrist who dismissed the seriousness of the withdrawal effects of SSRI antidepressants. Yet the notion of dependency is gaining traction. Moncrieff cited a recent high-profile example published earlier this year in the medical journal The Lancet. Author Mark Horowitz wrote: “All classes of drug that are prescribed to treat depression are associated with withdrawal syndromes. SSRI withdrawal syndrome occurs often and can be severe, and might compel patients to recommence their medication.” Patients have reported such symptoms as nausea, headache, dizziness, chills, body aches, paresthesias, insomnia, electric-shock-like sensations, panic attacks, dramatic mood swings, suicidal thoughts, and exhaustion. Horowitz’s coauthor, David Taylor, the director of pharmacy and pathology at a London hospital, described his own withdrawal from Effexor as a “strange and frightening and torturous” experience that lasted six weeks in a recent New Yorker article. Instead of denying the existence of withdrawal symptoms, these two authors make a strong case for tapering antidepressants very slowly. Among the known side effects of antidepressants are those affecting sexual function. Dr David Healy, a psychiatrist from Wales, runs a website that tracks the effects of SSRI antidepressants (RxISK.org) and other drugs. For many years, he has been collecting data from real-world patients who reported losing their sexual function even after stopping their antidepressant. Healy has used these data to petition the European Medicines Agency to put a warning about persistent sexual dysfunction on these drugs. Moncrieff, who is very familiar with this literature, reminded me that often the studies on antidepressants are simply too short to detect the effects such as long-term sexual dysfunction. In terms of SSRIs’ effectiveness on depression, Moncrieff said, “sometimes [patients] feel better, sometimes they don’t.” With her own patients, she said, “I couldn’t convince myself that antidepressants were having any significant effect. Some have said they’re basically active placebos.” A large meta-analysis (a summary of a large number of studies in the same area) published last year was reported extensively in the media with the message “antidepressants do work!” But Dr Moncrieff found many flaws. “They looked at response rates which inflate the actual effects, [whereas] if the results are looked at in the usual way, the analysis showed a very small and clinically irrelevant effect.” Moreover, she pointed out, in this meta-analysis, “an awful lot of those studies were withdrawal studies.” They studied people who were on antidepressants, comparing those who continued on their regimen to those who were switched to a placebo. So instead of measuring the effects of the SSRIs, they were finding that those switched to the placebo were doing worse—probably because they were suffering withdrawal symptoms. Moncrieff has a different approach to mental illness and its treatments than many other physicians. She spends a lot of time helping patients get off psychiatric drugs, but also trying to avoid putting patients on them in the first place. She told me most cases of depression “are responses to things that happen in people’s lives—and we need to figure out ways to help people to manage or address their problems—it’s dealing with the causes.” She mentioned a number of options—CBT (cognitive behavioural therapy), exercise, and mindfulness training, among them—that enable people to manage their mood or anxiety in a non-drug way. When a patient says, “I’ve done all those things and nothing works,” she recommends physicians discuss with those patients the evidence on antidepressants, how there is little to support their effectiveness, as well as the pros and cons of medication. She said that if antidepressant medication is prescribed, it should be viewed as a short-term measure, one which needs constant review and a willingness to stop. This is the evidence-based message she’ll be bringing to BC doctors in Vancouver on October 5 at a conference sponsored by the Therapeutics Initiative (see www.ti.ubc.ca). Alan Cassels is a drug policy researcher in Victoria.
  3. “Floxxed” patients are calling for better consumer drug information. APRIL GOODMAN had an appendix attack in 2015 and ended up in the hospital. Her appendix surgery wasn’t without its drama, but it was the drug that was prescribed afterwards that still haunts her to this day. Speaking to me from her home in New Westminster, she tells me she was prescribed an antibiotic called ciprofloxacin (Cipro), one of a number of fluoroquinolone antibiotics (these are drugs that end in floxacin). “No one—neither the doctor who prescribed it, nor the pharmacist who dispensed it mentioned a thing about the drug,” she said. She didn’t think anything about the drug’s safety either, until about a year and a half later when one of her back teeth broke. “When I read that Cipro has caused dental problems, such as teeth breaking off at the gumline, and further dental problems, which can continue indefinitely, I was quite alarmed.” What she uncovered in the course of several years of research is a truly astounding story of the floxacins, a widely popular class of drugs, wreaking devastation on an alarming number of people. She pointed me in the direction of a website, www.ciproispoison.com, where I learned a new word: “floxxed,” referring to a state of suffering from one or more of a long list of adverse effects related to this class of drugs. It seems mind-numbing that a drug you might take for less than two weeks to deal with an infection could cause long-term, and for some, irreversible adverse effects. This has taken a long time to acknowledge. April certainly wasn’t the first person to contact me about damages suffered due to fluoroquinolones. Over the last decade, I’ve had at least four different people write to tell me a tale of something truly horrendous, such as tendon rupture or retinal detachment, after taking a fluoroquinolone. Her concerns are echoed by official documents put out by various drug agencies in Canada. A 2017 report issued by CADTH (the Canadian Agency for Drugs Technology in Health) said this: “The use of systemic [taken by mouth or by injection] fluoroquinolones is associated with serious adverse events, [including] effects on the central and peripheral nervous system, hypersensitivity, myasthenia gravis exacerbation [a chronic autoimmune disease], phototoxicity, QT prolongation [a heart rhythm disorder], and tendon rupture. Rarely, some of these adverse events have the potential to lead to persistent disabilities.” Probably one of the more known risks of fluoroquinolones is its effect on tendons, which can sometimes become inflamed or even rupture. Health Canada warns that “rare cases of disabling and persistent serious adverse reactions including tendinopathy, peripheral neuropathy, and central nervous system disorders have been reported to Health Canada for fluoroquinolones.” In the glib, somewhat bureaucratic way they issue drug safety warnings, Health Canada helpfully reminds health professionals of the patently obvious: “Consider the potential for disabling and persistent serious adverse events when choosing to prescribe a fluoroquinolone. Avoid fluoroquinolones in patients who have previously experienced serious adverse reactions associated with them. Stop fluoroquinolone treatment if a patient reports any serious adverse reaction.” While there is growing public alarm at the overprescribing of antibiotics, fluoroquinolones can be effective if used properly. But they can also be terribly misused. WorstPills, an independent drug bulletin produced in the US, is direct and forceful in discussing the overprescribing of antibiotics in the US. It reports that “despite congressional hearings and numerous academic studies on this issue, it has become the general consensus that 40 to 60 percent of all antibiotics in this country are misprescribed. New studies continue to confirm the fact that a large proportion of antibiotic prescribing for both children and adults continues to be inappropriate.” WorstPills singles out the fluoroquinolones as “one of the biggest-selling and most overprescribed classes of drugs in the United States,” noting that these drugs should only be used for those allergic to alternatives or those with an infection resistant to other antibiotics. The problem here is typical of drug therapy—using the wrong drugs in the wrong patients and using fluoroquinolones for colds, sore throats, and bladder infections. How poorly they are used was captured in a 2003 study carried out in two American academic medical centres. The researchers looked at 100 patients who were prescribed a fluoroquinolone in an emergency room. Of those patients, 81 received a fluoroquinolone for an inappropriate indication (a use not officially approved by the regulator). Of those 81, half of the prescriptions were “judged inappropriate because another agent was considered first line.” Worse yet, for a third of those 100, there was no documented evidence that an infection was even present. In British Columbia, since the year 2000, when more than 150,000 patients were prescribed a fluoroquinolone, that number steadily increased until about 2010 when Health Canada started issuing the first of its warnings. Numerous programs have been launched to try to stem the inappropriate prescribing of antibiotics, including the public education campaign Do Bugs Need Drugs (www.dobugsneeddrugs.org). We are seeing that the number of patients who are prescribed fluoroquinolone antibiotics in BC has been steadily dropping since 2010. Yet even last year, almost 200,000 BC patients were dispensed a fluoroquinolone. THE WARNINGS AROUND fluoroquinolones continue to mount ever since the USFDA, in 2011, required that fluoroquinolone antibiotics must be dispensed with a Medication Guide, which is essentially a consumer-oriented operator’s guide to your drug. While the FDA has the authority to order that Medication Guides be distributed in pharmacies (and given out to patients who are getting new scripts or refills), no such authority exists in Canada. The safety information Canadians receive on most prescribed drugs is almost certainly inadequate, as April Goodman learned the hard way. For anyone prescribed a new drug, an important question might be: “is there a Health Canada warning on this drug?” Before new medicines hit the market, each country’s regulatory agency must first approve them for use, often based on limited safety evidence. After a drug enters general use, other safety issues can become apparent, including rarer or longer-term effects, prompting regulators to issue safety advisories on how to avoid or manage these risks. Barbara Mintzes, a researcher originally from Vancouver but now working in the Faculty of Pharmacy at the University of Sydney, is studying drug safety advisories issued by regulators around the world. She is running an international study looking at drug advisories, and discussed her study with me in Victoria last month. In a research letter she published in JAMA Internal Medicine, she looked at, in total, 1441 drug safety advisories issued in four countries—Canada, Australia, the US and UK—over a 10-year period, covering 680 drug safety concerns. Sadly, Canada didn’t fare too well. “Between 2007 and 2016, Canada’s drug regulator, Health Canada, issued safety warnings only about half the time related to issues identified by regulators in Australia, the US and UK,” said Barbara. “It’s concerning that all countries, including Canada, were seriously deficient in how they communicated emerging health risks of medicines.” She added that there were nine fluoroquinolone warnings for the study period (from 2007 to 2016 inclusive), in all four countries: four from Canada, four from the US, one in Australia, and zero in the UK. “Clearly if a drug has a safety advisory issued in one country, the same drug sold in another country should also come with similar warnings,” said Associate Professor Mintzes. “Overall, we found that regulators in these four nations were only consistent in the decision to warn 10 percent of the time.” According to research from the Canadian Institute for Health Information, from 2006 to 2011, emergency department visits and hospital admissions due to Adverse Drug Reactions (ADRs) among seniors in Canada cost an estimated $35.7 million. Much of this is preventable. For Barbara Mintzes, the prescription is clear: “We would like to see much more attention paid to ensuring that doctors and patients are informed of new evidence of harmful side effects of medicines, and what to do to prevent them.” April Goodman heartily agrees with that sentiment. If there’s one thing I’ve discovered after looking closely at drug safety for over two decades, it’s that people who have been through a drug disaster often become the most knowledgeable educators about the issue. These citizen experts can and do help educate the people around them to the dangers that could come via a simple pill. April Goodman, who has become extremely knowledgeable about fluoroquinolones, is a good example. She told me, “You have to be the CEO of your own health.” As for possible damages to teeth, she’s disappointed that neither Health Canada nor the US FDA has added that specific warning to the labels for these drugs. She has collected numerous articles warning of the potential for dental harm. “Many people, even young ones, are losing their teeth and get dentures after this Cipro harm.” With all the dangers she’s become aware of, she thinks that it might be time to pull the plug on this entire class of drugs. “I don’t think this is something that should be still on the market now.” Alan Cassels studies and writes about pharmaceuticals. He currently works at UBC.
  4. Are broken bones “hiding in plain sight” of heartburn meds? LAST YEAR MORE THAN 30,000 people in Greater Victoria took a pill from a class of drugs called Proton Pump Inhibitors (PPIs). This class includes drugs like omeprazole (Losec), esomeprazole (Nexium), rabeprazole (Pariet) or pantoprazole (Pantaloc). They are effective weapons in the fight against the scourge of modern heartburn, or what doctors call Gastro-esophageal Reflux Disease (GERD). Among the most popular and highest-selling of any drug class in the history of the world, PPIs have been an enormous success story both for the companies that make them, and the tens of millions of people around the world who swallow them every day. For many people, PPIs effectively suppress stomach acid in a way that makes the burning discomfort in your throat a long-forgotten memory. They work through blocking an enzyme in the wall of the stomach that produces acid. PPI is often a physician’s first choice of drug when a patient shows up complaining about heartburn. And did I say they were popular? In BC, nearly half a million people filled a PPI prescription last year, and in some parts of Canada, up to a third of the over-65 population may be chronically—that is, daily—swallowing a PPI. All of this comes with a hefty cost. At one point, British Columbians (through Pharmacare, extended health insurance and out-of-pocket payments) were spending $100 million every year on PPIs. That financial toll has dropped in recent years (down to about $60 million) due to PPIs coming off patent, allowing generic companies to sell cheaper versions of these drugs. Clearly, the massive consumption of even an effective drug raises many questions, the first being: Is there really an epidemic of heartburn in Canada? Is it wise to jump straight to a pill when there are several non-drug ways to prevent heartburn? If you really do need a drug, why this one? And lastly, if these drugs effectively relieve short-term heartburn, are they also safe if taken for months or years on end? Remember, stomach acid plays a key role in digestion. Because so many people take them, even if adverse effects are considered rare—occurring somewhere between one in 1,000 to one in 10,000 patients—the toll of injury could indeed be quite large. And many, many people will take them longer than the 4-8 weeks recommended for treating heartburn. The first PPI came on the market 30 years ago, and now there are six different ones available. I was drawn to research on the newest drug in this class, a product called dexlansoprazole (Dexilant), because of a question of rare but potential serious adverse effects. On PPIs in general, the medical literature contains no shortage of warning signals, which tells me that long-term chemical alteration of human stomach acid may be wreaking havoc on other body systems, raising rates of C. difficile infections, pneumonia and even possibly gastric cancers. There are numerous precautions listed in the Canadian dexlansoprazole product monograph, but I was drawn to the bottom of page four which read: “Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.” (Italics added.) Because patent-protected drugs are the newest and most widely promoted, I suspect that dexlansoprazole (still sold under patent) is the kind of drug that doctors in BC are currently stocking in their sample cupboards. NOAH NATHAN worked for Takeda, a pharmaceutical company, when it launched dexlansoprazole in 2009, under the brand name Kapidex (which was changed to Dexilant a year later). He was among the first salespeople in America to promote it. Speaking to me from his home in Ellicott City, just outside of Baltimore, Maryland, he told me he loved his job as a pharma sales rep. To keep the sales reps happy, he said, “the company treated us really well and spared no expense.” He had a company car and an expense account. During his 15-year career at Takeda, he was often among the top 10 percent in sales, and won awards including an all-expenses-paid trip to Australia. Whistleblower Noah Nathan His sales area was in Virginia, just outside of Washington, DC and his days would consist of driving around, making calls on doctors including gastroenterologists, ENTs (Ear, Nose Throat) specialists, and rheumatologists, pitching his company’s drugs, including Dexilant. In the course of his work, he fed a lot of physicians and their staff. “I really went for the comfort food,” he said, “rotisserie chicken, meatloaf with potatoes and gravy, that sort of thing.” He explained that the food might win him a valuable minute or two to talk up his products. Getting that face-time was crucial: “There’s such a big difference in prescribing, between those [doctors] who see us sales reps and those who don’t.” Yet over time, all of this delivery of food, samples, and information was starting to give Nathan indigestion. There was something about dexlansoprazole that didn’t exactly go down easy with him. He worried about the side effects and the dosages. When dexlansoprazole came to the market, Nathan explained, it came in two dose sizes—30mg and 60mg. The company tried to get a 90mg dose approved, but it was turned down. As a sales rep, however, it was only the higher 60mg tablet being promoted. All the sales materials were built around the 60mg dose. In fact, Noah explained, the newer company reps often didn’t even know about the 30mg dose, and many doctors in the field didn’t either. Currently in North America, more than 90 percent of the prescriptions for dexlansoprazole are in the higher 60mg doses. When dexlansoprazole was being reviewed by the US FDA to determine whether the drug should be allowed on the market, two FDA reviewers didn’t like the look of it. In their judgment, one of the reviewers wrote that not only was there no additional benefit of dexlansoprazole over the other five PPIs already on the US market, but that the evidence showed a higher incidence of fracture/injury-related adverse events with dexlansoprazole compared to other drugs. To grant the company marketing approval, the FDA required the company to carry out a “post-marketing clinical trial.” Basically, the FDA allowed dexlansoprazole on the market as long as Takeda promised to produce additional safety data, which was due to the FDA in December 2011. Over seven years later, no results have been posted to the FDA website. Nathan became an unexpected whistleblower and later an author. In his self-published book, Heartburn, Broken Bones, and the False Claims Act: Nathan v. Takeda Pharmaceuticals—Why You Should Care About the Case You Never Heard Of, he estimates that half a million Americans are taking 60mg doses of dexlansoprazole. The court case that he launched in 2009, and which ended in 2014, was premised on the issue that the company was likely promoting the drug “off label” for the higher dose, possibly putting patients at risk for fractures and other complications related to high dose PPIs. Promoting a drug for unapproved uses is illegal in the US, yet quite hard to prove, even if you’re someone like Noah Nathan with insider knowledge on how the company worked. After gathering further data (including wearing a wire to record company meetings) his case was rejected. His case probably wasn’t as solid as it needed to be to pass the court’s strict standards, but as he told me, had he been in a different state, things could have looked a lot differently. He said that “the courts ruled against me, while potentially putting American patients at risk.” Over those five years, Nathan lost his marriage, his job, and the case that could have strengthened safety precautions for other patients. Admittedly he was outgunned, facing off against some of the biggest law firms money could buy. I asked him if it was worth it, and he was quick to admit “being a whistleblower is hard,” but he’s more worried about the overall issues for public health. It’s possible that Nathan vs. Takeda might set a dangerous precedent, making it harder for other whistleblowers to succeed. Ultimately, he thinks that justice will eventually be done: “public opinion will eventually catch up,” he said, “when the lawsuits start piling up and people are suing for bone fractures related to the drug.” He adds, “for sure, there are broken bones out there, hiding in plain sight.” The lesson here is a precautionary one—that effective drugs in the short term can often wreak havoc in the long term. Taking any new drug is often a gamble, and the statement in the product monograph to “use the lowest dose for the shortest period of time” is an axiom that stands the test of time not only for PPIs, but for almost all drugs. Victoria resident Alan Cassels has spent 25 years researching and writing about pharmaceuticals. He currently works at UBC.
  5. The government doesn’t pay for it yet, but the pressure from Big Pharma is on. IN THE FALL OF 2016 a new flu vaccine became available in Canada, promising to provide much better protection for senior citizens. Known as a high-dose trivalent inactivated vaccine (HD-TIIV) and sold under the brand name Fluzone, the vaccine was promoted as a weapons-grade tool in the fight against the flu among our most vulnerable population—seniors. We were told it contained four times as much antigen compared to standard-dose quadrivalent inactivated vaccine (QIV), for the three strains the vaccines share in common. While this is not the first time I’ve tried to inform Focus readers about campaigns to shape our thinking about diseases and drugs, or questioned whether the best available evidence supports mass influenza vaccination, the high dose of propaganda floating around this flu season seems particularly noxious. The drama hinges on a key question: Would millions of dollars more—either from BC taxpayers or the pockets of seniors themselves—make any real difference to the annual burden of influenza? The so-called “awareness-raising” (mostly by industry) around this new flu vaccine is not only exposing all of us to the scariest of statistics around the flu, but seniors’ groups, doctors and pharmacists have been even more intensely targeted. “Seniors are at high-risk for the most severe consequences of flu, including hospitalization and death,” we are told in ads and public service announcements, adding that “up to 91 percent of flu-related deaths occur in those 65 years of age and older.” Repeated public health appeals to get the flu shot seem to be singling out older people and their weaker immune defenses, but for me this targeting raises a contentious question: If the flu is so bad, how many people die of it every year? The Public Health Agency of Canada, which runs the FluWatch program, says they get, on average, 23,000 lab-confirmed cases of influenza reported to them each year. Acknowledging that the “burden of influenza can vary from year to year,” they estimate that in Canada there are an average of 12,200 hospitalizations related to influenza, and approximately 3,500 flu deaths every year. These are projections, based on modelling, but that 3,500 number gets repeated ad nauseum. But is it true? Two months ago, a CBC story reported actual FluWatch data that said Canada had 302 flu deaths last year. In whose interest is it to exaggerate these numbers? I guess it only matters when you thoughtfully consider what game is going on. As every marketer knows, you don’t sell the steak, you sell the sizzle. Big Pharma is happy to have the projections and estimates sound dramatically scary, even if they are as much as ten times inflated from reality. In Canada, a national body called the National Advisory Committee on Immunizations, or NACI, said that Canadians over 65 should be offered this high-dose flu vaccine on the basis of “good evidence of better efficacy compared to standard-dose” flu vaccines. They suggested that older people suffer from “immunosenescence”—a waning immune system as they age—and hence older people are at greater risk of severe illness from the flu. This apparent need for stronger stuff buttresses the case that an “extra strong” vaccine is needed to protect our seniors. NACI’s Canadian Immunization Guide said that Canadian provinces “may use any of the four influenza vaccines available for use in adults aged 65 years and older: standard-dose TIIV, the HD-TIIV, adjuvanted TIIV, and QIV (quadrivalent influenza vaccine).” However, the organization also recommended “at an individual level, the HD-TIIV should be offered over standard-dose TIIV to persons 65 years and older because of the expectation of higher effectiveness.” This means it’s better, right? Others aren’t so sure. The BC Centres for Disease Control looked closely at the science behind the vaccine and said additional studies were needed to confirm whether the HD-TIIV vaccine’s effects are consistent “across seasons and vaccine strains.” They also said they didn’t know if the vaccine “warrants preferential recommendation and public funding over other available options.” The new high-dose vaccine costs about $80-$90 per shot, about five times as much as a standard flu shot. Saying yes to the vaccine would cost BC taxpayers millions more than we already spend. This would be money well spent if it saved more lives and kept more people out of the hospital, but…let’s dig into the numbers. The pivotal trial of HD-TIIV enrolled more than 30,000 people comparing it to standard-dose TIIV. The results? The HD-TIIV reduced the risk of influenza by 24 percent. It sounds pretty impressive, but what does that number really mean? The study, carried out in seniors who lived in their own homes, found 1.9 percent of those getting the standard-dose vaccine developed the flu, versus 1.4 percent who got the high-dose vaccine. While it’s a 24 percent drop to go from 1.9 to 1.4, it’s also a 0.5 percent difference (1.9 percent subtract 1.4 percent = 0.5 percent). This means that half a percent of seniors were saved from the flu. The CDC concludes that “an additional 200 such individuals would need to be immunized with the high-dose product to prevent 1 additional case of influenza.” Also, one person in 4,000 vaccinated would avoid a hospitalization. The high-dose vaccine showed no effect on deaths. So if you trust the study, the HD-TIIV vaccine increases grandma’s chances of avoiding the flu by 1 in 200. The converse of this is that 199 of every 200 people vaccinated with the HD-TIIV will see no benefit. The researchers’ conclusion and recommendation to the Ministry of Health speaks volumes: “the strength of the evidence and anticipated incremental benefit of HD-TIIV relative to standard dose TIIV is not commensurate with the additional 5-fold cost...” As of press time, the BC Ministry of Health seems to agree. It does not cover the HD-TIIV, likely because it costs five times as much but doesn’t help 199 of the 200 people who get it. My back-of-the-envelope math says that for $16,000, the high-dose flu shot will help prevent one additional flu case in seniors; it would cost $320,000 to prevent one hospitalization (that’s just for the vaccine, not for administration costs). And there is no evidence the high-dose vaccine saves lives. For drug companies in Canada, however, the big enchilada in sales is provincial coverage. If their drug or vaccine isn’t covered by the provincial government, their profits will be smaller, and they will have to rely on people paying out of their own pockets or having private insurance. Among Canada’s 13 provinces and territories, only Ontario funds the HD-TIIV for all adults aged 65 and older. Saskatchewan, Manitoba, Nova Scotia, P.E.I. and Northwest Territories cover it for seniors in care facilities. BC does neither. But the pressure is on. Over the last year I became aware of at least four different Canadian seniors’ organizations who have been lobbied by the company promoting the high-dose vaccine. The company offers conference speakers, workshops and webinars to “educate” seniors about the threat of influenza and the benefits of various vaccines. The punchline: You deserve the best, so lobby your government to pay for this vaccine! (The BC Liberal Opposition introduced legislation in October to cover costs of the high-dose drug for seniors.) These promotions have the veneer of being public-spirited and helpful, especially when the companies propose their own speakers to educate senior’s groups, offering free sessions on the dangers of influenza and so on. Putting vulnerable seniors into the cross hairs of big Pharma’s direct marketing tactics doesn’t please everyone. One member of a seniors’ organization based in Vancouver (who asked that his name not be used) was blunt with me: “Sanofi, the third-largest drug corporation in the world, has generously provided expensive restaurant meals and delivered their sales pitch to retired teachers’ groups in BC as part of promoting their new and very costly flu vaccine.” He added that “BC seniors cannot easily access independent information about the efficacy of new drugs, and neither can family doctors for that matter, so some seniors are now lobbying their provincial government to cover them. Constant TV advertisements marketing these new vaccines reinforce a message of fear and the need for urgent preventative action.” Also jumping on this bandwagon are a variety of national patient and seniors groups “partnering” with the vaccine makers to sponsor flu awareness campaigns. There is evidence that the marketing to health professionals is also in full action mode, and the way this works is usually through the digestive system. The manufacturer will sponsor a dinner at a nice local restaurant and invite community pharmacists or local GPs to attend a dinner lecture. They’ll either feature their own “Key Opinion Leader” or work with a local GP or pharmacist to deliver the goods with a company-provided slide deck. Don’t be shocked, this is Drug Marketing 101, and a time-worn way for the company to make sure our doctors and pharmacists buy into their version of this lifesaving vaccine. All this is perfectly legal, of course, despite the fact the doctors and pharmacists I know become somewhat red-faced when I ask them what they think of their colleagues being wined and dined with company presentations and other pharma-funded schmoozing. What can we do about this? I’d recommend a much higher dose of skepticism among the public and our health professionals as a partial antidote. We need to be reminded that we allow this kind of sneaky marketing and flu-mongering at our peril. But here’s my big worry: Maybe the growing distrust that many Canadians feel around flu propaganda will lead to a greater public reaction, causing fewer and fewer people to trust what they are being told about the value of other vaccines. Alan Cassels is a Victoria-based drug policy researcher and author whose motto is “We need clean, clear health information as urgently as we need clean, clear water.” He works for UBC’s Therapeutics Initiative but the opinions represented here are his and his alone. Follow him on twitter @akecassels.
  6. Can we trust health-related media to deliver clean, clear health advice? FREQUENTLY THE MEDIA does a fabulous job of informing the public on health-related matters. Many Canadians trust health journalists to deliver factual and important assessments of new drugs and other medical treatments. But sometimes they miss the mark by a wide margin and deliver messages that threaten to turn more people than ideal into patients. The most recent example comes via one of CBC’s house doctors, Dr Peter Lin, who frequently appears on CBC radio talking about medical matters. A few months back, he spoke about a new trial around blood pressure-lowering which suggested that there were millions of Canadians who needed to be working even harder to bring their blood pressures down. He was referring to a trial which generated a lot of media coverage called SPRINT, which examined this question. In our assessment, his interpretation of that study was completely backwards. A quick search of the medical literature revealed that Dr Lin is not only a CBC regular commentator on medical affairs, but also consults with several drug companies—18 to be exact. His online bio discloses that he has consulted with Astra Zeneca, Bristol Myers Squibb, Takeda, Purdue, Boeringher Ingelheim, Bayer, Eli Lilly, Amgen, Jansen, Forest Laboratories, J&J, Merck, Novartis, Pfizer, Servier, Sanofi, Abbott, Mylan, and that he also does continuing medical education for the companies. These drug companies pay him. It is common for researchers or physicians to have financial conflicts of interest related to the pharmaceutical industry. We know that those conflicts can affect drug recommendations. In fact, most high-quality evidence on this issue comes to the same conclusion: compared to non-conflicted commentators, those with ties to the drug industry have much more positive opinions about the good effects of drugs, and tend to ignore or downplay the adverse effects of those drugs. Furthermore, they are more likely to recommend more costly, branded drugs rather than cheaper generic or non-drug options. These facts are supported by decades of research on drug marketing, and are at the heart of the drug industry’s return on investment (ROI) analyses. Those ROI analyses demonstrate that investing in key opinion leaders, such as Dr Lin, is a useful strategy that delivers high returns: more prescriptions and more revenues. When I (Alan) complained in an email to the CBC Ombudsperson about the CBC not dislosing Dr Lin’s conflicts of interest, a managing editor at CBC News acknowledged the importance of the issue, but stated, “The issue is not, then, whether Dr Lin has relationships with private companies. It’s whether those relationships create a conflict by influencing the medical decisions he makes—and in particular whether they affect the advice he gives our listeners. To that point, we are not aware of any such conflict affecting the work he has done for us. If you have a specific such instance to flag for us, we would be happy to look into the circumstances.” My follow-up letter will address the SPRINT example. One of the most contentious areas of drug utilization is the use of pharmaceuticals to lower blood pressure. It is true that high blood pressure can raise the risks of stroke and heart attacks, an association that has been known for years. The question anyone with high blood pressure might have is this: How low do I need to go? In other words, what optimal target blood pressure should I be aiming for if I want to maximize the length and quality of my life? In a city like Victoria, with many older adults who have been told they have “high” blood pressure, or hypertension, this is not a moot point. Too aggressively lowering blood pressures in older people can be serious because it can lead to dizziness, falls and fractures. Our research found that most of the trials of blood pressure medications are on younger, healthier populations, and so cannot be extrapolated to older, more frail people where slightly higher blood pressure is normal. The largest trials in an older population suggest being very conservative with treatment. One Swedish study of individuals over 85 said that the ideal systolic blood pressure is in the range of 140 to 160 mmHg. In other words, the sweet spot of ideal blood pressures changes as you get older, and doctors should not try to treat your grandmother’s blood pressure like she was 20 years old. On this subject, Dr Lin quoted on CBC from the SPRINT trial, a trial designed to answer the question of the optimal blood pressure target. He discussed how this study showed that aiming to get blood pressure levels to a lower target (say around 120 systolic, the upper number) is a strategy that would save more lives. Urging those with “moderate” high blood pressure to do what they can—sometimes taking three or even four different antihypertensive drugs—to achieve these lower targets is a message the pharmaceutical industry would appreciate. What he didn’t mention is that the best answer to this question doesn’t come from a single study, it comes from examining the global body of studies designed to answer the question. He failed to mention there was a published Cochrane Review on this question of blood pressure targets. That review, which summarizes the best available evidence, concluded “treating patients to lower than standard BP targets,” (that is, less than 140-160/90—100 mmHg), “does not reduce mortality or morbidity.” Our researchers with the Therapeutics Initiative at UBC have analyzed the SPRINT trial. Contrary to Dr Lin’s opinion, that analysis found that the benefits of lower blood pressure targets do not outweigh the harms. In fact, in the SPRINT trial, the magnitude of the harms was greater than the magnitude of the benefits. (ti.ubc.ca and search for “SPRINT.”) The main thing you should know is that we are not alone. Hundreds of researchers around the world are involved in deeply analyzing drug trials as part of groups like the Therapeutics Initiative, and the Cochrane Collaboration. They work independently from pharmaceutical industry funding, and cautiously examine the evidence of drug effects. If physicians want to be credible, authoritative and trustworthy media commentators about drugs, they need to refer to the best, least-biased information possible, looking at the totality of evidence, not single trials that are islands unto themselves. Is it even reasonable to expect an unbiased view of drug therapy effects from spokespeople who have multiple close ties to pharmaceutical companies? We would never expect this in other domains: think about an expert from the oil and gas industry talking about global warming, or a judge deciding the merits of a case, but not telling anyone he was married to the defendant, or owed the defendant money. Certainly you would call those flawed, potentially-biased situations. The same is true with the pharmaceutical industry, where funded experts with financial ties are more likely to see the evidence a certain way. When physicians or other media spokespeople speak about medical matters, we should expect nothing less than full disclosure about any ties to makers of drug products. Medical media that might be skewed towards the private interest of companies instead of the public interest of citizens has the potential to hurt the people it is intended to help. Alan Cassels’ disclosure: “I have been an independent pharmaceutical policy researcher for 25 years and have never taken any money from the pharmaceutical industry. I currently work for UBC’s Therapeutics Initiative, which is funded by the BC Ministry of Health, and have, in the past, been paid on contract as a contributor to CBC Ideas and CBC Syndication. I have also authored a book about the Cochrane Collaboration.” Dr Jim Wright’s disclosure: “I am the founder and Co-Managing Director of the Therapeutics Initiative at UBC and the Coordinating Editor of the Cochrane Hypertension group. Hypertension reviews can be found at www.cochrane.org.” This article represents the opinion of Alan Cassels and Jim Wright, and should not be construed as an official viewpoint of the Cochrane Hypertension Group or the Therapeutics Initiative.
  7. Why hope, hype and headlines should never substitute for clean, clear analysis. SO-CALLED "RARE DISEASES" are those that affect less than one in 2000 Canadians (.05 percent), and for which companies often sell drugs priced at hundreds of thousands of dollars per patient per year. Parsing the pharmaceutical forecasting literature, I’ve come to understand that the drug market for rare diseases is huge, growing, and seems to be the main area where the industry is putting much of its current research efforts. Why? For the same reason famous bank robber Willie Sutton kept robbing banks: “Because that’s where the money is.” Money, and lots of it, seems to be at the heart of a narrative that repeats with alarming frequency: along comes a new and expensive drug—characterized in the press as “lifesaving” and essential, yet priced into the stratosphere. It could mean a slight increase in a patient’s quality of life, yet priced at $250,000 per patient per year, how much “quality” are we really buying? Here in Victoria over the last year, headlines have been filled with heart-wrenching stories featuring drugs like Orkambi for cystic fibrosis, and Ilaris, which treats a rare disease called systemic juvenile idiopathic arthritis (SJIA). Then there was Soliris, which treats atypical hemolytic-uremic syndrome (aHUS), an extremely rare disease. It is among the priciest drugs we’ve ever seen, costing around $700,000 per patient per year. It’s no wonder governments everywhere in the world are reluctant to pay for these medications, and that the stories of patients being denied access make headlines. Each time a new “breakthrough” drug is either so expensive, so experimental (where there’s little data on the drug’s efficacy and safety)—or both—that the provincial drug plans won’t cover it, there is public outcry. Sometimes the Ministry of Health gives in, and sometimes it doesn’t—leaving one with the distinct impression that political pressure might play a larger role than science when determining whether a new, expensive drug becomes a covered benefit. Would any of us call this an optimal system? The narrative never seems to change—only the drug names. While some journalists love to advocate for a good cause, what if the cause they are jumping aboard is one where they only know half the story? Maybe instead of providing lifesaving treatment, the new drug actually leads to more people suffering and dying, due to some unknown toxicity. Could that happen? It happens all the time. The Michener Award is considered one of the most prized honours in journalism, recognizing “meritorious public interest journalism in Canada.” A Michener is like an Olympic Gold Medal for reporters, recognizing the best of the best in what is the highest calling in journalism: the public interest. In 2006, I wrote a letter to the Michener Awards committee complaining about the 2005 winner. I felt that the Globe and Mail writer who won the award did so with a series of articles about a new and expensive breast cancer drug, Herceptin, that was so biased and misleading, it most certainly caused great harm to the psyches of women with breast cancer, as well as wasting huge amounts of money in funding from public drug plans. I felt the articles undermined the independent scientists who were suggesting caution. The committee ignored me. I based my letter to them on work I and my colleagues did, documenting the reporting of trastuzumab (brand name: Herceptin), a treatment for adjuvant breast cancer, for over a year. Here’s an excerpt of what I wrote: “From our perspective, 2005 was a long summer of frustration as Herceptin generated breathless front page coverage based on a poor explanation of the drug’s absolute benefits, and an improper assessment of risks and uncertainties related to this treatment. We found that the Globe’s news reports of Herceptin routinely broke simple principles of proper pharmaceutical reporting, creating excitement and demand for what are unproven treatments. This has the effect of driving provincial health departments into rapid, yet potentially harmful funding decisions which can have serious adverse effects on patients and the health system; not what you’d call ‘public interest’ journalism.” Herceptin, used after chemotherapy treatment, was advertised, promoted and lobbied for on the basis of a “50-percent reduction in tumour recurrence for all clinical-trial participants.” The drug was tested in a special population of those with breast cancer: the 30 percent of them who have the HER2 gene, which can affect growth of breast tumours. The women in the trials had been treated for breast cancer, and the drug was prescribed to avoid a recurrent tumour. But that figure of 50 percent is misleading; the Globe (as well as other media outlets) were reporting the relative numbers from the clinical trials. In one of the key randomized trials of the drug, about 10 percent of the women given the placebo developed a new breast tumour over 3 years. Of those who took Herceptin, only 5 percent developed a recurrent breast cancer in that time. Using relative math logic, if you go from a 10-percent risk (placebo patients) down to 5 percent (Herceptin patients), that’s a 50 percent reduction. “Cuts cancer risk in half!” proclaim the headlines. But whoa! In absolute terms, the drug really only contributes to a five-percent reduction, because 10 minus 5 leaves 5. In other words, the difference in benefit of the drug over the placebo is only 5 out of 100—only one in 20 taking this drug will benefit. Based on those data, doctors would have to give Herceptin to 20 women with this certain type of gene—after being treated for breast cancer—for 3 years, to prevent one recurrent breast tumour. In the Herceptin stories we examined, another thing was obvious: the harms of the drug were consistently downplayed, or simply not mentioned. We knew (closely parsing the clinical trials) that Herceptin increased risks of congestive heart failure, infection, and vascular disorders. In this case, 3.5 percent more women taking the drug experienced these effects than those who took the placebo. And here’s the kicker: there was no overall improvement in survival in the Herceptin group. Basically, after a summer of hyped headlines, lobbying, and beating up the Ontario government for not covering Herceptin, it turned out the drug was not a lifesaver. Why was the Ontario government reluctant to pay for it? Maybe because it cost somewhere between $30,000 to $45,000 per patient per year (now about double that), and would “break the bank” of the Ontario drug plan. The citation for the Globe’s 2005 Michener Award for meritorious public service journalism reads: “One series about the breakthrough breast cancer drug Herceptin prompted provincial government to fast-track the drug approval process and expand use of the drug. It had been restricted to women who were dying of breast cancer.” Let’s be clear: all the media activity, all the personal heart-wrenching narratives of individuals begging for a drug that they claimed was helping them wage their personal war on cancer, was genuine and heart-felt. But it was also based on a big misunderstanding of the facts. The company made millions on the basis of that one drug, and the media campaign was so powerful, and so overwhelming, even women who didn’t have the HER2 gene started pestering their doctors for prescriptions for Herceptin. (It’s now on BC’s list of approved drugs for treating breast cancer.) It is possible that certain people may be helped by new and expensive drugs. It is also possible they may be harmed, or die taking the new treatment—at the expense of millions of dollars wasted. Original drug trial reports contain both spin and bias, and it seems most reporters aren’t asking enough tough questions. Tragically, many vulnerable patients get an unnaturally rosy picture of a new medication through these media reports and end up feeling desperate—that without this wonder-drug, they will surely die. A few years after the Herceptin debacle, I saw a major Canadian study which emerged with this headline: “What we know of breast cancer drugs may be spin & bias.” This examination found that of 164 major cancer drug trials, a third were biased in how they reported the benefits of the treatment, and two-thirds spun the reporting of the toxic effects, downplaying or ignoring them. In other words, what we discovered around the Herceptin story is not an outlier. Spin and bias are all part of the packaging around a new drug. Noteworthy villains in any media/drug saga include the academic researchers who produce slanted reports—sometimes quite unreliable—of the drugs they study; and the “advocacy” journalists who allow themselves to be unwittingly employed as part of the drug company’s PR strategy. The collateral damage is clear—just ask the terrified patients who get caught up in the corporate profit machine. Here’s the lesson I learned many years ago, which we must keep relearning: we need clean, clear, health journalism as urgently as we need clean, clear water. Our lives depend on it. Alan Cassels is taking a break from pharmaco-journalism for the time being. He continues to work as a reviewer with healthnewsreview.org which analyzes and evaluates health reporting, and now works at UBC.
  8. The growing movement to wind back excess medication. JOHANNA TRIMBLE KNEW SOMETHING WASN'T RIGHT with her mother-in-law Fervid. Fervid Trimble was an energetic 87-year-old living in a seniors’ residence who woke up one morning feeling dizzy. Found to be dehydrated, she was treated and admitted to the health centre for a few days of recuperation. New medications were prescribed: digoxin for her heart, antibiotics for an infection, and drugs for pain. Fervid was unhappy. She grieved for her independent life—so then came the antidepressants. She was now on nine different medications. What worried Johanna was the more drugs that were added, the worse Fervid’s mental health became. She became confused and delusional, totally unlike the Fervid her family knew. Johanna’s library background led her to start researching. Her research told her that drug side effects and drug interactions commonly cause older people to suffer from the medicine that is supposed to help, and that those problems were rarely discussed with doctors. Fervid’s decline was likely drug-related. Her family then insisted on a “medication review” to distinguish the helpful drugs from those causing problems, and Johanna got her wish: a staff-directed “drug holiday” which started a reduction in medications that essentially brought her mother-in-law back to life. Fervid was able to enjoy several more years of relatively healthy living surrounded by a family who loved her, instead of living in a scary drug-induced haze, getting more medication than she needed. Since those events more than a decade ago, Johanna, who lives in Vancouver, has become a champion for the rights of patients, especially when it comes to overdrugged seniors. As a member of the BC Patient Voices Network and the Canadian Deprescribing Network, she advocates for better, more rational drug therapy for older people. The key problem that she and others have long identified is one called “polypharmacy,” which is often defined as taking five prescription drugs or more at a time. This is not a small problem. Two-thirds of Canadians over the age of 65 take at least five prescription medications per day, and one-quarter of Canadians take ten or more. Greater Victoria has the country’s fifth-highest percentage of people aged 65 and better—about 70,000 people. According to statistics, seniors have a one-in-200 likelihood of being hospitalized due to the harmful effects of their medication. This translates to 350 hospitalized seniors in Victoria per year—almost one every day. The bigger picture isn’t bright either: drug safety experts estimate that adverse drug reactions (ADRs) are endemic in our drug-centric health care system, and considered to sit somewhere between the fourth and sixth leading cause of death. According to material produced by the Canadian Deprescribing Network (deprescribingnetwork.ca), which is made up of interested health care leaders, researchers and patient advocates, older people are particularly vulnerable to the effects of too many medications. While these advocates are trying to bend the curve on overprescribing, and ensuring that there is both the confidence and mechanisms in place to help people stop medications that may be useless or harmful, the reasons older people end up on so many drugs is complex and sometimes difficult to unravel. Victoria resident Janet Currie is currently attending UBC doing a PhD in drug safety. She is a long-time advocate for better awareness of psychiatric medications and founded a website— www.psychmedaware.org—devoted to helping people stop these medications. Also on the executive of the Deprescribing Network, she describes a typical patient this way: “This patient is on ten or more drugs and they are taking drugs that they might have been prescribed decades ago, including sleeping pills and benzodiazepines” (which are typically prescribed for anxiety and insomnia). The problem is that nobody is tracking possible drug effects which could cause dangerous falls, problems with memory, insomnia, indigestion or pain. Anytime a person is on multiple drugs, the risk of adverse drug reactions is increased. Also, seniors have reduced ability to metabolize drugs, and should be given lower drug doses than other adults. Janet Currie How does one counter the inevitable accumulation of drugs in the medicine cabinets of elderly people? Currie is quick to respond: “The first thing they need to know is what drugs they are on—and this is not always easy to find out.” You can request a “medication review” by a doctor or pharmacist, where they’ll methodically go through a person’s medications, determining what they are for and if they are still needed. Within the deprescribing community there is some debate about whether to worry most about the types of drugs being prescribed or the numbers. Clearly you have to consider both, but for Currie, mostly the numbers count. “Anyone on 10 or 12 drugs is going to have a real risk of drug interactions. The main thing is to reduce the total number of drugs.” AROUND THE COUNTRY there are people working to resolve the problems of deprescribing. There are research groups at Hamilton, Ottawa and Montreal that I am aware of that are testing ways to help doctors reduce the medication burden of seniors. There are conferences where new guidelines for deprescribing are being launched, and others developed. Though I’ve long understood polypharmacy from an academic point of view (full disclosure: I worked with a group to develop www.medstopper.com as a tool to help doctors deprescribe), it wasn’t until I took my own 81-year-old mother to the doctor for what is called a “complex care visit” that I truly understood the magnitude of the problem. This visit with my mom’s doctor was longer than most visits, and designed for the doctor to take the time to do a complete assessment, and suggest therapies for many of the multiple challenges that many older people have. It also involves an extensive medication review. This was a big eye-opener. I intimately knew which drugs my mother was on—a total of 7 outside a few puffers and asthma medications. Over the years I had shielded her from taking what we considered the more useless and potentially harmful drugs typically thrown at seniors. I acknowledged that anyone who has survived a few heart attacks may benefit from some meds, and those “necessary” drugs were on her list. As well, however, there was a heartburn pill (pantoprazole) which I couldn’t figure out. Why was she taking that? “Mom do you have heartburn?” “No,” she said, “Never had heartburn in my life.” “Well you’re on a heartburn drug.” (I know that pantoprazole is routinely prescribed in hospitals.) “Why am I on a heartburn drug if I don’t have heartburn?” she asked. “Maybe you got it when you were in the hospital?” I said. But that was years ago. “Do you want to keep taking it?” I asked her. “No. I tell you, I don’t have heartburn,” she insisted, getting a bit feisty. So I gently suggested to my mother’s doctor that the heartburn pill was probably unnecessary and she’d like to stop it. Then I got to see how even the thought of stopping a drug seemed to make the doctors nervous (there was my mother’s doctor and a resident who was shadowing her). “Are you sure?” they wondered aloud. “Maybe she was on the drug for a reason? Maybe the specialist put her on it?” they mused. Their hesitancy seemed bizarre. After all, I have studied prescribing for many years: no one puts that much thought and hesitancy into prescribing a new drug. But stopping one? Wow. You’d think the heavens would fall. I said something like: “You know the main thing that matters to my mother is her comfort. If she’s not comfortable being on a drug which no one can justify, why not just stop it? If she develops any heartburn symptoms, you can start her up again, ok?” And in the end, this was agreed to. I always thought deprescribing would be easy. It’s harder in real life. With a ton of drugs, you certainly should stop the ones that can’t be explained. Then you should eliminate those that are useless, harmful, or seriously degrade the person’s quality of life. At the end of the day, there is one inviolable principle: the patients’ wishes trump all. This is not easy, especially in a world where “do what you’re told” medicine dominates. Challenging your medication regime takes energy, commitment, and some assertiveness. I remember what Currie said on that topic: “It is important that the family be involved—and both the senior and the family be clear on why a drug is being taken. Does it make sense to have a senior on a lot of prevention drugs like statins if they have never had a heart problem or stroke? Remember that all drugs cause side effects, so a drug should be really needed before it is taken.” After all, for many people the drugs aren’t going to give them a lot more life, but they can seriously affect the life they’ve got left. It’s never too late to start questioning and cutting back. Alan Cassels has studied pharmaceutical policy and prescribing for 24 years. He is currently transitioning to a new position at UBC.
  9. Exposing Big Pharma’s dark influence on doctors who diagnose and prescribe. DAVID HUNTLEY HAD AN INFECTED TOOTH, so his dentist referred him to an oral surgeon who told David he needed surgery. But when David explained which drugs he was taking, the surgeon refused to do it. I had never met David, an 81-year-old retired professor of physics who lives in Burnaby, but I knew pretty quickly why oral surgery wasn’t an option for him: He was being treated for osteoporosis, and had been prescribed denosumab to treat the disease, colloquially called the “silent thief,” which puts people at risk of fractures. Now what does the bone-thinning disease have to do with dentists refusing to perform surgery? One of the most serious, but rare, adverse effects of osteoporosis drugs—known as bisphosphonates—is osteonecrosis of the jaw. If it sounds nasty, well, consider this: Osteo=bone + necrosis=death. The jaws of some patients taking bisphosphonates can literally fall to pieces. Many adventures in the medical world often start with a trip to a specialist, which leads to a test, then a diagnosis, then a drug. David doesn’t remember why his GP sent him to get the initial X-ray, but that led to a referral to an endocrinologist in Vancouver who I’ll call “Dr X.” Dr X used a specialized X-ray machine called a DXA, which measures bone density and spits out a figure known as a “T-score.” David’s T-score was -2.8, and he asked the doctor to explain what it meant. “After some questioning, [Dr X] mentioned ‘standard deviation,’ but beyond that, I don’t think he knows. Either he doesn’t know or he wouldn’t explain it,” David told me. Dr X told David that given his T-score, he had a “high probability of breaking something in the next several years.” He prescribed David a twice-yearly injectable bisphosphonate drug called denosumab (Prolia) and vitamins. I have been more than a casual observer of the osteoporosis industry for over 20 years, and I can be confident about only one thing regarding this disease: Everything about it is controversial. For starters, its very basis, the “T-score,” which defines what is and isn’t osteoporosis, was crafted during a critical meeting at the World Health Organization (WHO) in 1994. Attended by specialists in bone health—as well as various pharmaceutical company officials—that WHO meeting defined “normal” bone density as that of an average 30-year-old woman, which automatically meant that nearly 30 percent of post-menopausal women had the disease, and were hence deemed “high risk” of having a fracture. After that crucial meeting, women who were 50, 60 or 70 years old, with normal bone density for their age, were told they had a disease. Some loss of bone density happens naturally over time, a process as natural as grey hair and wrinkles. Yet once it is measured, along comes a diagnosis, and then the drugs. The bisphosphonates, which include drugs like Fosamax, Actonel and Zometa, are also controversial, due to their minimal effectiveness and toxicity. There’s very little evidence that they actually help patients avoid future bone fractures, and longer-term use of bisphosphonates actually increases one’s risk of bone fractures. Having pharmaceutical companies sitting at the table defining disease usually ends the same way: The disease appears more common, bigger, more dangerous, and more likely to lead to some kind of drug therapy. By mid-1995, the world’s osteoporosis industrial complex was launched, boosted into orbit by major pharmaceutical company Merck, which bought up and distributed DXA machines around the world—while their bisphosphonate, Fosamax, became an über-blockbuster. Fast-forward 20 years or so, and there are at least half a dozen bisphosphonates on the market, taken by millions of people. The most effective ones may help prevent one out of 100 women with established osteoporosis from having a hip fracture. Which is to say, on that function alone, they are 99 percent ineffective. And they make dentists nervous. David didn’t recall being told about osteonecrosis of the jaw related to bisphosphonates, nor did he know that FDA warnings on bisphosphonates indicate they can cause severe and occasionally incapacitating bone, joint, and/or muscle pain, dangerously low levels of blood calcium, as well as serious infections of the skin, abdomen, urinary tract and heart valves. I told David that his story seemed so familiar because the industry around measuring and medicalizing bone density has been colonized by the pharmaceutical industry, and underwritten largely by those companies selling bisphosphonates. I really didn’t want to get into it, but I was pretty sure Dr X was on the pharmaceutical industry payroll. WHY WOULD A PROMINENT VANCOUVER SPECIALIST be so swayed to prescribe denosumab to a relatively healthy man? Follow the money. Most of the major osteoporosis societies in the world receive substantial injections of funds from the makers of bisphosphonates, and, with some easy searching, I found Dr X sits on osteoporosis committees at the provincial, national and international level. He lobbies for the DXA scans and drugs to be covered. He also has extensive ties to global drug companies that make bisphosphonates. How extensive? One of his conflict-of-interest disclosures (taken verbatim from a peer-reviewed journal) reads: Dr X “consults for, receives research grants from, or is on speakers bureau for Procter & Gamble, Merck, Novartis, Eli Lilly, Wyeth, GlaxoSmithKline, Biosante, Servier, Amgen, Johnson & Johnson, and Pfizer.” Amgen, by the way, makes denosumab (Prolia). We are all, in a way, like David, unaware of the possibility that the specialist giving us advice is also financially tied to the companies making the pills being prescribed. Here in BC, it appears we’ve banned big money in BC politics, and that’s a good thing. But have we banned big money in medicine? Not yet. At the national level, a campaign called Open Pharma is calling for a “dose of transparency” (www.openpharma.ca) and wants “all drug companies with products listed on their formularies to publicly report any transfers of value, e.g., money, gifts, meals, made to doctors.” The issue here is not about disallowing payments between doctors and drug firms, but about making those payments transparent. Right now, as a first in Canada, Ontario has introduced legislation forcing drug companies to divulge their payments to health professionals. As well, one drug company (GlaxoSmithKline) has started voluntarily disclosing payments to physicians and healthcare organizations. Ontario’s new legislation looks a bit like the US Physician Payments Sunshine Act, which forces medical and drug companies in the US to reveal their compensation to individual physicians, whether they sit on advisory boards, and so on. Some European countries, plus Australia and Japan, have sunshine laws. But mostly, in Canada, any money passing between a drug company and physicians remains largely secret. Given the world’s attention on the opioid epidemic, and emerging evidence that opioid makers in the US and Canada spent millions of dollars to educate physicians about the alleged safety of opioids, you can understand why consumers might be alarmed. What if the specialists who are seeing us, testing us, and prescribing drugs are working “under the influence” of millions of dollars of pharma funding? As of now, BC has no “sunshine” legislation, but our Health Minister says it’s coming soon. Here in BC, it’s clear our doctors haven’t gotten that memo. The Doctors of BC has no existing policy on this. As its communications spokesperson Sharon Store wrote in an email: “The closest we have is the following recommendation from one of our policy papers from a decade ago: The BCMA supports the CMA [Canadian Medical Association] guidelines on appropriate relationships between physicians and the pharmaceutical industry and encourages other health care providers to adopt similar guidelines.” To update that a bit, in 2012 the CMA’s General Council approved a motion calling on “pharmaceutical companies to make information concerning their relationships with all physicians receiving any financial or non-financial compensation publicly available.” In my opinion, being transparent is only the start. The long-term goal should be to remove any corporate influence on prescriber education. Up to half of the funding for ongoing education of BC prescribers is coming from the pharmaceutical industry. We know, for example, that osteoporosis specialists, many of whom are highly financially conflicted, are often the ones who teach other doctors. Astonishingly, we allow this. Do our doctors learn of the controversies of the disease, the problems with the medicines, or the potential for serious adverse effects of the drugs? Some might, but that doesn’t seem good enough. We shouldn’t have to rely, as David did, on our dentist to inform us that yes, sometimes drugs have dangers. Alan Cassels is a Victoria writer and health researcher. His most recent of four books is The Cochrane Collaboration: Medicine’s Best Kept Secret.
  10. Can a new government remove the stench of Big Pharma’s lobbying at the BC Legislature? ONE THING I MOST REMEMBER about living in Asia 20 years ago was the ever-present smell of sewage. It was fairly subtle most of the time, but occasionally I would catch a powerful whiff of something rising from faulty plumbing or seeping up from the street drains. It’s the metaphor I think of when I consider politics here in BC, where every so often the stong scent of corruption wafts from the comingling of business and government. But maybe that will all change if a breeze of transparency—in the form of campaign finance reform and limits to lobbying—starts to blow through Victoria. Getting big money out of the political system and changing the legislation that affects the behaviour of lobbyists could certainly help clear the air. People who spend any time in the BC Legislature or work in the various ministries will tell you that lobbyists representing petroleum, real estate or pharmaceuticals (among others) roam the halls like they own the place. These “government relations” people (former MLAs among them) fill the calendars of our legislative members, snatching face-time to air their views and ensure the government maintains the “right” perspective on policies affecting their industry. Currently, other than being required to register that they are lobbying and who they might be lobbying, there is no way to find out who was actually lobbied or what was talked about. The centrepiece of the new provincial government’s lobby reforms is a mere tweaking, a required two-year “cooling off” period where those leaving public office are prohibited from acting as lobbyists (this includes cabinet ministers, their political staff, and other senior people, down to the assistant deputy minister level). Lobbyists must also disclose the names of any staff person working in the minister or MLA’s office with whom they speak. Dermod Travis with Integrity BC probably knows the activity of BC’s lobbyists better than almost anyone in the province. He is adamant that “we need checks and balances—knowing who was actually lobbied and what was discussed,” but unfortunately that information won’t be found in the BC Lobbyist Registry. Travis laments how close the relations can be between government and business, recalling a 2013 BC Chamber of Commerce private, $275-per-plate dinner with all of the Deputy Ministers. Participants (mostly lobbyists) paid to dine with the deputy of their choice. The Deputy Minister of Health at the time, Stephen Brown, was photographed with officials from Purdue Pharmaceuticals (famous makers of Oxycontin, believed to be the key gateway drug responsible for our opioid epidemic)—not exactly the kind of people you want to be glad-handing our senior bureaucrats. So who is keeping an eye out for the public when it comes to pharmaceuticals? With BC Pharmacare spending upwards of $1.5 billion every year on public drug coverage, does this not make the BC Ministry of Health a prime target for drug lobbyists? Let’s say you are a drug manufacturer producing many products you believe doctors should be prescribing. Your singular goal is driving profits and growing customers. You therefore put a very high priority on getting BC taxpayers to pay for your products; with over four million potential customers eligible for coverage through Pharmacare, government payors may mean the difference between success and failure. What complicates this is that you’re also competing with other companies who make similar products, and they want their drugs covered. Enter the lobbyists. BC’s Lobbyist Registry is a good way to find out who has been registered to lobby for whom, and which ministers they wish to influence. In it are dozens of drug companies. Let’s choose one at random, starting with A: AstraZeneca Canada, a major pharmaceutical company making 50 or so drugs, not all of which are covered by Pharmacare. The diabetes drug exanatide, sold in two forms by AstraZeneca under the trade names Bydureon ($2,493 per year) and Byetta ($1,457 per year) are classed by Pharmacare as “non-benefits,” so if your doctor prescribes those drugs, there is a good chance you’re paying for them on your own, or hoping your employer’s health coverage will kick in. Brillinta (ticagrelor), another Astra product, is an antiplatelet drug used to prevent blood clotting, heart attacks and strokes. It used to be available for coverage through Pharmacare, but now it is not. Drug companies like Astra are so profitable they can hire some of the best lobbyists (I mean, er, “government relations” people) around. If you are one of our newly-elected MLAs—and especially if you work in health, education, or economic development—expect to be on the sharp end of the lobbying activities of Big Pharma companies like Astra. On July 27, 2017, AstraZeneca Canada registered seven people as lobbyists in BC. Their “business or activity summary” on the BC Office of the Registrar of Lobbyists website says they focus on “Innovative Life Sciences/Economic Development Policies; Health as an Economic Generator of Wealth in British Columbia; and Health Policy/Reimbursement decisions.” Let me translate: Even if Astra asserts that they “push the boundaries of science to deliver life-changing medicines” (according to their website), they are there to meet with our MLAs for business reasons. They will say their drug products might be beneficial to our economy, but the bottom line is to make sure taxpayers pay for Brillinta, Byetta, Bydureon and the dozens of other drugs they make. In late September, the group tasked with assessing new cancer drugs in Canada (called the pan-Canadian Oncology Drug Review or pCODR) gave a positive “recommendation for the reimbursement of Lynparza® (olaparib).” Astra’s so-called “first-of-its-kind treatment for BRCA-mutated ovarian cancer” promises patients “improved progression-free survival.” Sounds great, and why wouldn’t you want the government to pay for that drug? As an MLA or a minister, it would be hard to say no to a drug that appears to help people suffering from what is often a fatal cancer. We only know, broadly, what companies like Astra want from our politicians. Astra’s filing on the lobbyist registry says they are lobbying for “Information in support of provincial access and reimbursement of AstraZeneca’s medicines.” In other words, how do we get BC Pharmacare to pay for our drugs? Lobbyists have a financial incentive to paint their company’s products in the best possible light. (Some are even paid on contingency: If they earn their company positive cash flow from a policy decision, then ka-ching!) BUT WHAT WILL OUR MLAs LEARN about the drugs they are asked to cover? Will they learn that Byetta (according to its product monograph) has been “associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis?” Will they learn that there are lawsuits against the company suggesting that the link between Byetta and inflammation of the pancreas means the drug may actually cause pancreatic cancer? Will they learn that Astra may have submitted false data to the FDA to get Brillinta approved in the US, and is alleged to have omitted information regarding deaths and other adverse events associated with it? When it comes to olaparib, are there going to be any lobbyists telling Adrian Dix and his staff that if you look closely at the clinical trials, it actually made life worse for patients? (Its cost, if covered by the Province, will likely be in the millions.) What’s the takeaway? Seven lobbyists from one company, multiplied by dozens of drug companies, against one health minister. We need a stiff breeze of transparency blowing through the halls of the legislature, especially when it comes to the millions we spend on pharmaceuticals. There is some suggestion that recent reforms are only a first step. Maybe there will be, somewhere down the road, some real deodorizing acts that can freshen up the close, sweaty relations between drug lobbyists and those who decide on how to spend our health dollars. The future, if we choose, could smell really great. Alan Cassels is a Victoria writer and health researcher. His most recent of four books is The Cochrane Collaboration: Medicine’s Best Kept Secret.
  11. Our new provincial government faces a litmus test in how it deals with diabetes-mongering. THE FIRST LINE of Diabetes Canada’s 2017 Report on Diabetes in British Columbia contains a whopping big lie. But let me get to that in a bit. The report outlines outrageous levels of diabetes in BC, how it costs the provincial health-care system over $400 million per year and how BC is awfully stingy in paying for diabetes-related products. For example, did you know that in BC not everyone can get a subsidized insulin pump? Nor do we pay for the newest diabetes medications. And don’t ask about foot care, because the state of foot care for people with diabetes in BC is appallingly bad. In other words, we’ve got an epidemic on our hands and we are inadequately supporting people living with diabetes. The report is basically saying to our new NDP government: Time to ante up. Thank you for waiting, here’s the whopper: Today, more than 1.4 million British Columbians, or 29 percent of the provincial population, are living with diabetes or prediabetes. I remember standing on a parade square, an officer cadet in boot camp, with a bunch of other skinny teenagers with shaved heads and a sergeant yelling at us: “Look to the person on your left, then look to the one on your right. And by the time we’re done here, one of youse will be gone.” That’s the kinda drama that certainly gets your attention—because you, or your closest buddy, could easily become a statistic. But wow. Nearly a third of us have diabetes or almost have diabetes? Diabetes can be serious, and if so many are at risk of getting it, it surely demands a weapons-grade response from someone. Hence the report and the eye-popping stats. But we are nowhere near having 29 percent of British Columbians living with diabetes or prediabetes. Why? It’s waaaaay more than that. Statistically, almost everyone who lives long enough will develop some kind of elevated blood sugars that are associated with diabetes. Not only do we all have pre-prediabetes, let’s not forget that 100 percent of us are also “pre-deceased,” struck by a condition that is universally fatal. But I digress. Diabetes Canada is—how do I say this nicely—marinating in pharmaceutical funding. Able to hire some of the best public relations firms in the business, their job is to get provincial health officials focused on their bottom line, increasing the market for drugs, insulins and assorted diabetes paraphernalia. Maybe their report reads like it was written by a drug company because it is funded by Novo Nordisk Canada, one of the world’s largest producers of insulin; and it directs questions to Hill and Knowlton Strategies, a PR behemoth. BOTH TYPES OF DIABETES, the adult-onset type, known as Type-II, and Type-I which typically develops in childhood and requires daily use of insulin, can undermine the quality of one’s life. The vast majority (over 90 percent) of people living with diabetes in BC are type-II diabetics, and so that’s where most of the marketing is targeted. The term “prediabetes” has long been a controversial term so I turned to a colleague, Colleen Fuller, a Vancouver-based diabetes policy expert, and asked what she thought of the report. Fuller started her answer with a question: “Why does Diabetes Canada use terms like ‘prediabetes?’ In Europe they are highly critical of the term. Why? It causes panic. It is designed to scare people,” she said. Fuller thinks that current Canadian diabetes guidelines should be used with caution, “because they are mainly designed to increase sales of drugs and devices.” She adds, “It is clear that the drive for these companies is to consistently grow the market.” Sure enough, the report’s three key recommendations are focused on public spending for more diabetes stuff, recommending that “the Government of British Columbia immediately…Expand the provincial insulin pump program to include all British Columbians with type 1 diabetes who are medically eligible, regardless of age.” It also urges the government to “List diabetes medications with proven efficacy on the provincial drug formulary” and “Commit to public funding of offloading devices and foot care specialist visits, and improve screening for diabetic foot ulcers and education.” I asked Don Husereau, an Ottawa-based expert on evidence-based policy who has a graduate degree in pharmacy, whether he thought the recommendations had any basis in evidence. He was quick to respond: “The first one will significantly increase expenditures for little advantage—pumps are only useful [for a] few people and necessary in fewer.” As for the paying for diabetes drugs, Don Husereau asks: “What is ‘proven efficacy’? Is that code for A1C [a test for measuring the blood glucose level] or code for heart attacks?” The latter, drugs that prevent heart attacks, might indeed be a good thing, yet the former, drugs that do nothing but alter the level of haemoglobin A1C, he says, could be “useless.” As for avoiding diabetic foot ulcers, which the report says costs us up to $120 million a year, Colleen Fuller supports that recommendation, because “people need to pay attention to their feet,” but she adds, “they should educate people generally about diabetes, not just about feet.” She reminded me that we used to have very good diabetes education programs operating out of hospitals in BC. “If you went to a diabetes educator [she went every year for 20 years] it was good—you found out about food, and different aspects about what you need to know about diabetes.” In her opinion, “the lack of education about food is a major contributor to the increase in Type-II diabetes.” But what has happened in BC? “They got rid of the education programs,” says Fuller. Even though the World Health Organization tells us that “unhealthy diets and low physical activity are among the key risk factors for major chronic, non-communicable diseases such as cardiovascular diseases, cancers and diabetes,” this merits a small mention in the Diabetes Canada report: “about 40 percent of residents are not physically active, 60 percent do not eat enough fruits and vegetables, and half of the adult population is overweight or obese.” Instead of suggesting ways to get people more active and eat better, let’s just berate the BC government for not paying for more diabetes stuff. As Don Husereau reminded me, the bulk of the evidence on diabetes drugs shows that they may be very effective at lowering blood sugar, but have very little effect on the things that matter: the complications of diabetes that include kidney disease, strokes and heart disease. In fact, despite the piles of medications available to treat type-II diabetes, there is shockingly little evidence of overall benefit. A recent report by the Therapeutics Initiative at UBC was an eye-opener. It found that most of the drugs that lower glucose for people with type II diabetes are “approved without any evidence that they reduce mortality or major morbidity.” They are, of course, very effective at making massive amounts of money for the companies producing them. DIABETES COULD BE the poster-child for what happens when we allow the medical-industrial complex to “educate” governments about diseases: disease-mongering on a massive scale. Convince policymakers that we have an out-of-control epidemic of “predisease” (which some say doesn’t really exist) and then promote the most expensive drugs and devices to deal with it. Colleen Fuller, who has watched the diabetes industry for decades, has a suggestion about such “polluted” recommendations: “The government needs to raise the bar of evidence to justify public funding.” She wants more independent study, and more objective analysis of public coverage of diabetes paraphernalia, and adds that “Pharmacare as our public drug program has to be an advocate for rigorous studies around diabetes.” Groups such as UBC’s Therapeutics Initiative have spent the last decade in the wilderness, sidelined by the Liberal government, the Ministry of Health firing scandal, and numerous attempts to disrupt their work. Things now may be looking up, especially since Premier John Horgan recently mandated our new Minister of Health Adrian Dix to, among other things, “provide the Therapeutics Initiative with the resources it needs to do its job effectively.” This means better science and independent advice—not tainted by the drug companies and the societies they fund—so that our diabetes-related resources will be used to maximum impact. This was confirmed when I asked the Ministry of Health what they thought of the report. Spokesperson Laura Heinze wrote that the ministry “will be looking at enhancing evidenced-informed decision-making for new and existing drugs in relation to formulary coverage decisions.” As a final note, Colleen Fuller reminds me that the World Health Organization has linked the growth in diabetes to poverty. Too often, she says, people with type-II diabetes are “blamed for being lazy and fat, yet if we want to prevent diabetes we’d address the socioeconomic or environmental causes of the disease.” Those don’t seem to be priorities of the disease-mongers, which Fuller characterizes this way: “Their job is to push products—not strategies, not things that would prevent people from getting diabetes in the first place.” There is hope. However, this new report shows the Diabetes-Industrial Complex has targeted our new NDP-Green government. The ministry will need all the help it can get to stand up to them. Will the ministry have the cajones to take on the Diabetes-Industrial Complex? This is a litmus test. We’re watching. Alan Cassels is a Victoria writer and health researcher. His most recent of four books is The Cochrane Collaboration: Medicine’s Best Kept Secret.
  12. Confusion around chicken pox and shingles could be costly to Victoria consumers. I WAS HALFWAY THROUGH writing my Focus article about the way prescribing guidelines have been hopelessly infected by pharmaceutical industry funding, when two strong wind gusts changed my tack. The first pushed me toward a sandwich board in front of Shoppers Drug Mart on Douglas Street, urging passers-by to come in and get a shingles vaccine. The second was a June 20 report in the Globe and Mail that pretty much sucked the wind from my sails on the issue of corrupted prescribing guidelines. Some of us have been writing about this problem for decades, so I’m happy to see that the scribes at Canada’s national paper have discovered that maybe drug-company corruption of prescribing is actually a major problem. Sandwich board in front of Shoppers Drug Mart on Douglas Street But that sandwich board’s bold message of the link between chicken pox and shingles rang like a symphony of bells at Christ Church Cathedral. I’m attuned to a deep ringing chorus of mistruths, but the sorry gap between the medical science and the marketing in this case was begging for a comeuppance. It’s especially urgent given that this case involves someone coming at you with a hypodermic needle. For starters, the link between varicella zoster (also known as chicken pox) and herpes zoster (also called shingles) is anything but certain. In 1888, Bokai, a Budapest physician, may have been the first to hypothesize the link, but many others have since suggested the same thing. Today the US Centers for Disease Control and Prevention says point-blank that “shingles is caused by the reactivation of the varicella zoster virus (VZV), the same virus that causes varicella (chickenpox).” According to current medical thinking on the issue, it is believed that once a person has had chicken pox (which is usually mild and happens in early childhood), the virus is thought to remain dormant in the dorsal root ganglia, which are nerve cells. The virus can sometimes erupt (usually in people older than 65) to cause a painful rash, known as shingles. If you’ve seen ads for Zostavax, Merck’s vaccine against shingles, you’ve an idea of how nasty the condition can be. Rows of red, painful, itchy welts can wrap around your torso, and even infect your neck, face or eyes. While the disease can be particularly bad, and the desire to avoid the torture suggested by fiery strings of barbed wire wrapping around you understandable, the main question we need to ask is: For most of us who had chicken pox as a child, how likely are we to get shingles? The quick answer is not very. For starters, the research says shingles is simply not that common. One report, examining 21 studies in Europe, found that for kids and young adults it’s rare—somewhere between one to two cases per thousand people per year. That increases to about four per thousand up to age 50, and seven to eight per thousand for people over 50. About one percent of people over 80 are at risk every year for contracting shingles. Despite the rarity of the disease, fear-mongering and vaccine shilling abounds. Medical journal articles, the Shopper’s pamphlet, and Merck’s ads all tout the “one-in-three odds of getting shingles in your lifetime!” This is the same category of misleading information that says all women have a “one-in-eight lifetime chance of getting breast cancer,” ignoring the fact that this only applies to women who live to be 85. You can, however, get shingles at any age, and those with immune-deficient conditions, such as HIV, leukemia or lymphoma, have to be very careful. Many otherwise healthy people who get shingles might have a few weeks of troublesome symptoms as the disease goes away on its own. Only about a quarter of shingles cases will result in complications, such as severe rash and pain. As for the causal link between having chicken pox when you’re younger and developing shingles when you’re older, the jury is still definitely out. One researcher, Dr Chris Shaw, who studies vaccine safety, told me from his office at UBC that in his mind there “is no strong link between chicken pox and shingles,” even though he acknowledges that the official story says the opposite. I found one study which said that exposure to chicken pox increases your risk of developing shingles later in life, but also showed that adults who live with children are naturally exposed to a lot of chicken pox. The result? This exposure can be “highly protective” against developing shingles later in life. This is echoed by Dr Eva Vanamee, an adjunct assistant professor at the Icahn School of Medicine at Mount Sinai in New York, who told me by email: “If you are exposed to chicken pox from time to time then your chances of getting shingles is much lower.” What she says next is compelling, and reminds me of the power of immunity: “Pediatricians used to have the lowest incidence [of shingles] due to their constant exposure. So the virus hides out and can cause shingles but the boosting provides protection, which is now pretty much lost with the vaccine.” So, what does all this mean? Should we allow our kids to naturally get chicken pox, or try to vaccinate against it? WHEN MY KIDS WERE IN PRESCHOOL, now more than a decade ago, I remember a notice coming home alerting parents that chicken pox was in the school. How did we react? Like most Fairfield parents, we sent our kids off to the pox-infected school anyway. After all, getting exposed to “the real thing” will make you develop the immunity you need, right? We were told that a person seriously doesn’t want to get chicken pox as an adult, so better to expose the little ones now. The funny thing I remember is that a few of the kids who did get the pox had already been vaccinated. The manufacturer of the Varivax (chicken pox) vaccine admits this possibility on its label: Protection isn’t guaranteed, nor is the duration of protection really understood. Funnily, it adds that the vaccine’s effects on preventing (or getting) shingles downstream are unknown. Some experts are decidedly wary of the value of the chicken pox vaccine. According to the Vaccine Information Center in the US, “Mass use of chickenpox vaccine by children in the US has removed natural boosting of immunity in the population, which was protective against shingles, and now adults are experiencing a shingles epidemic.” I’d say the prevalence to date I’ve seen hardly suggests an “epidemic,” but it is clear the number of annual cases of shingles have been rising for at least a decade. So, even if it may not be true, as Shoppers Drug Mart tells us, that chicken pox puts us “at risk” of developing shingles, should we get the vaccine anyway? Based on my reading of the evidence, the shingles vaccine “works,” but I would add one qualifier: “barely.” A 2005 trial studying the effectiveness of the shingles vaccine published in the New England Journal of Medicine enrolled more than 38,000 people over 60. Over three years, Zostavax reduced “the occurrence of herpes zoster by 51.3 percent.” Here’s the kicker though: The vaccine is measured in “1000-person years” where the effects are noted among 1000 people for one year. The study found that the vaccine dropped the rates of shingles per 1000 person-years from 11.12 (those on placebo) to 5.42 (those given the vaccine). The difference is only 5.7 people per thousand per year (11.12 minus 5.42 equals 5.7). Since 5.42 is “51 percent” less than 11.12, that’s where you get the “51 percent reduction” number. Let’s be clear: The shingles vaccine won’t make your risk go from 100 percent down to 50 percent—which is what most people think when they see “a 50 percent reduction.” Actually it helps about five people per thousand per year. With those sorts of numbers, the NNV (Numbers Needed to Vaccinate) is 233—the pharmacy would have to vaccinate 233 customers to avoid one person getting shingles. At $230 per dose (current price at Shoppers Drug Mart, including the $20 injection fee), it would cost more than $50,000 to prevent one case of the shingles. Like those odds? How about the fact that in August 2014, the vaccine’s label was updated, telling us that Zostavax might actually cause shingles. What a strange world this is. THE GOOD NEWS, for me, is that the BC government won’t pay for it. Why? They won’t say, but Lori Cascaden at the BC Ministry of Health told me by email, “the Ministry continues to consider it alongside other vaccines for British Columbia’s publicly funded immunization schedule.” I have to say, I have a good feeling about pharmacists. The Douglas Street Shoppers pharmacist I chatted with was a very nice guy, and it was clear to me that he went to pharmacy school to help people. I’m sure many pharmacists will have mixed feelings about the business they’re in, working in tandem with corporations flogging vitamins and other supplements, pharmaceuticals that have little effect, or vaccines that are marketed with scare tactics on sandwich boards. I feel for them, and I’d like to see them more as allies in distributing good information about diseases and vaccines, rather than propaganda produced by manufacturers. Alan Cassels is a Victoria writer and health researcher. His most recent of four books is The Cochrane Collaboration: Medicine’s Best Kept Secret.
  13. The Ombudsperson’s 500-page report delivers condemnation, but leaves us hungry for an answer to “Why?” IN JANUARY OF 2013, I took a felt pen, and wrote on a sticky note: “Who killed Rod MacIsaac?” I stuck it in the corner of my computer monitor and it stared at me for the next two years, a daily reminder of a big unknown that many of us have struggled to piece together and understand. What kind of cruel, twisted logic operating within the bowels of the BC Ministry of Health would have ordered the termination of this UVic co-op student three days before his work term was set to complete, an event which undoubtedly contributed to his suicide three months later? While the 2012 firing of six other Ministry drug safety researchers and a contractor was utterly dumbfounding, nothing was more inexplicable than the brutal efficiency of MacIsaac’s termination. With the April publication of the BC Ombudsperson’s report Misfire: The 2012 Ministry of Health Employment Terminations and Related Matters some say the whole sordid episode is over and we now have answers. The report is a complete and total vindication of all of those fired employees, and is a monumental attempt to explain how this train wreck happened. While its 512 pages identify many wrongs, and recommend measures to ensure no fiasco like this ever happens again, one can still be left feeling hungry after parsing its contents. It explains in great detail how Rod MacIsaac and his colleagues were fired, but it fails to deliver on the most important question of all: “Why?” Maybe the best way to describe the health firings scandal as summarized in the Ombudsperson’s report is: “Mistakes were made (but not by me).” Carol Tarvis’ excellent book by this title delves into the self-justifying human brain that, in response to mistakes of our own making, creates fictions which “absolve us of responsibility, restoring our belief that we are smart, moral, and right.” The corollary to this, of course, is that these fictions can work to keep us on a “course that is dumb, immoral, and wrong.” The most obvious missing ingredient in the report is responsibility. No one owns this mess, and no heads will roll—neither the premier, the various political operatives, ministers of health, their deputies and assistant deputies who oversaw the investigation and firings, nor the staffers who carried out the investigation with the élan of Gestapo police. The biggest human resources scandal in BC government history, and not a single person will be punished. Astonishing, no? Produced after apparently reviewing millions of documents, and interviewing 170 people under oath, the Ombudsperson has officially captured the obvious: This has been an unmitigated disaster, a gross miscarriage of justice, and was followed by a cover-up that has left an essential part of BC’s health system in smoldering ruins. Despite the apologies, settlements and promises of ex gratia payments to demonstrate goodwill to those who were so wronged, the lack of any accountability is stunning. In fact the opposite has occurred. The deputy minister who signed the letters terminating the employees was himself fired, with a nice $461,000 golden handshake to guide him on his way as he turns his health file connections into a lucrative job in the medical marijuana industry. Other high officials who dishonestly said the RCMP was involved, and tainted everyone with an unjustified criminality, are still in office. Some of the staffers have been promoted, moving on as people do in a government town to other ministries and other jobs. And other senior executives have retired and moved to warmer climes, living worry-free knowing that whatever destruction they may have helped orchestrate in the Ministry of Health, it will never come back to haunt them. The investigation which led to the firings, was, according to the Ombudsperson, heavy-handed, mean-spirited, and acted far beyond the standards expected of the public service. The descriptors “flawed,” “biased” and “unfair” litter the document, yet any fingerprints that may have linked the fiasco to the BC Liberals, and their pharma-friendly policies, have been “disappeared.” Nothing to see here, folks. Most of us knew all along that the investigations and the firings were unjustified, but the most troublesome thing is how long it took to try to refloat the ship. Once eight people were thrown out the door in September 2012, it took nearly two and a half years of foot-dragging, public demands for justice, and one failed mini-inquiry (the Marcia McNeil Report) before the matter got handed over to Jay Chalke, the Ombudsperson. While it was even clear several months after MacIsaac was terminated that mistakes were made, no one owned up or tried to fix things. Why? That question still haunts me. I know I’m not the only one to notice the happy coincidence between the needs of Big Pharma (not wanting independent drug safety research done on their products) and the politicians (on the receiving end of drug lobbying and political donations) who kept staff in the Ministry from really trying to get to the bottom of this and fixing things. JAY CHALKE'S REPORT contained 41 recommendations, all of which were accepted with alacrity by the government. Those 41 items mostly relate to reparation payments to those affected, and suggestions to improve Ministry policies. The most important, in my mind, relate to resuming the culture of research we used to have in the Ministry of Health. For instance, the report recommends: “By September 30, 2017, the Ministry of Health review and assess the extent to which the termination of evidence-based programs during the internal investigation may have created gaps that now remain in providing evidence-informed, safe, effective and affordable drug therapy and related health care services to British Columbians.” The government promised to release a plan to address any identified gaps by December 31, 2017. These so called “gaps” are what affects us all, because halted research doesn’t just affect the people who do it (including myself), it endangers public safety. Anyone in this province who takes drugs for cholesterol, high blood pressure, infections, Alzheimer’s disease, smoking or ADHD is affected because programs we had to study drug use, and try to educate physicians, have been halted and not resumed. The state of data analysis paralysis, which consumed the Ministry of Health in the wake of the firings, continues to haunt it today. If the Liberals wanted to kill the research and evaluation activities of its Pharmacare branch, they couldn’t have found a more effective way to do it. Many of the staffers in the Ministry of Health know this, and want to fix things—and they need to know that the public and the politicians have their backs. But it’s going to take time, and, most of all, political will. BC has an asset that is truly “world class,” established by an NDP government back in 1994. It is PharmaNet, one of the most comprehensive, linkable pharmaceutical databases in the world. Having this makes BC one of the world’s best places to study drug policies, and could also likely make it the easiest place in the world to ensure we use pharmaceuticals safely and wisely. The biggest potential downside to this fiasco going forward is fear about using BC data to evaluate policies. Not evaluating our own drug- use data and using it to improve prescribing will continue to foolishly sacrifice lives. The starkest example of inaction on that front is the current opioid epidemic, where BC could be a world leader in safe, appropriate opioid use, instead of the epicentre of a disaster that kills, on average, three people per day. What do we need going forward? We need risk-takers in government. I know it’s awfully hard to change any organizational culture, especially one that has been through the wringer like the Ministry of Health. We need people to make decisions in the right direction, and people willing to rebuild a culture of inquiry committed to using public data in the public interest. You don’t get let off the hook when public health is at stake. The politicians need to realize this: that what happens under their watch is their responsibility. People in the senior civil service serve “at the pleasure” of the politicians. There is no “off the hook” with public health. We don’t know who killed Rod MacIsaac, but maybe we can make sure he didn’t die in vain, and that the career he aspired to—doing independent analysis of drug-use decisions—is something that can grow and thrive in BC. The Ombudsperson recommended establishing a scholarship in memory of Rod MacIsaac at UVic. In a gesture that is highly symbolic, it could also be seen as hugely aspirational. We cannot begin to undo the damage done until we recognize that we are all wearing the mistakes that led to Rod MacIsaac’s death. We have allowed a government to be tainted by pharmaceutical interests, where a fiasco like this can happen and the perpetrators go free. Future governments that forget where the public interest lies will do so at their peril, and ours. Alan Cassels is a Victoria writer and health researcher. His most recent of four books is The Cochrane Collaboration: Medicine’s Best Kept Secret. CTV legislative reporter Stephen Andrew filed this story about Rod MacIsaac's death in January 2013: City filed this report in October 2014, including a statement by Rod MacIsaac's sister:
  14. The “selling sickness” model is in full display in pushing grade 6 boys towards a questionable vaccine. DESPITE THE TITLE, be assured I am addressing this to all busy parents—both moms and dads who juggle households, careers and kids in sports—in the hope that you might take a few minutes to learn about a decision you will soon be asked to make. If you are the parent of a middle-school boy in the fall of 2017, you will be asked to get your son vaccinated for the human papilloma virus (HPV) that is linked to cervical cancer. Since your son doesn’t have a cervix, you might be wondering, uh, WTF? To which I would say, haven’t you heard of the worldwide epidemic of anal and penile cancers, not to mention an incredible rise in HPV-related genital warts? I know this because I follow health media closely and followed a huge bolus of vaguely familiar scare stories passing through the digestive system of the media last fall. These stories featured the same prominent patient “spokespeople” telling us that we need to be worried about the genital health of our boys. Clearly this was a textbook disease-mongering campaign, where the marketers know that raising the spectre of a horrific epidemic of something (in this case it’s a virus, but it could be your cholesterol or bone density) will often drive you to the doctor to demand something to deal with or avoid it. Well, the BC government decided last month they might as well just give in and submit to the corporate-sponsored media messages linked to the HPV vaccine makers Merck and GlaxoSmithKline, two of the world’s biggest pharmaceutical companies. Along for the ride were the Canadian Cancer Society and assorted industry-linked cancer researchers who were all playing their part in the lobbying machine designed to get the government to subsidize the vaccine for boys. Promotions even featured a 13-year-old boy from BC who apparently was part of a human rights complaint against the BC government because they only paid for the HPV vaccine for girls. Sheesh. Using kids for a pharma-sponsored marketing schtick strikes me as a crime against humanity. But I digress. At the very least, the $400 vaccine becomes a seamless way to transfer our tax dollars to two big pharmaceutical companies via your boy. I’ve been a professional chronicler of selling sickness for over 20 years. Selling Sickness is the name of the 2005 book I wrote with Australian journalist Ray Moynihan. Way before there was even an HPV vaccine, Ray and I were documenting the pharmaceutical industry’s thorough involvement in the creation and selling of disease in order to expand markets for their products. From pumping up a little-known risk factor into a disease, then funding the care and feeding of researchers and specialists, while enlisting the professional media to drive interest, and fuelling the legislative campaigns to get a new drug covered, we’ve seen it all before—because that’s how the model works. In the marketing of the two HPV vaccines which target a few strains of the virus believed to lead to some forms of cancer, they often downplay one simple fact: The vast majority of us will get HPV in our lives and clear it like the common cold virus. Gardasil, the first vaccine for HPV, started being recommended for girls in 2006, despite the lack of any proof it has prevented a single case of cervical cancer. Persistent HPV infections may increase a woman’s risk of cervical cancer and a man’s risk of HPV-related anal, penile, mouth and throat cancers (especially if they sleep with other men). Even though the Centres for Disease Control (CDC) recognizes over 40 distinct types of HPV infection which can infect the genital tract, they say “about 90 percent of infections are asymptomatic and resolve spontaneously within two years.” Then why is there such a push to vaccinate all boys? (Boys with “increased risk” because they have sex with men, are questioning their sexual orientation, are street-involved, infected with HIV, or are in care or in custody, are already eligible for free vaccination.) Well, the two vaccine makers are doing what drug companies do best: They are trying to expand their markets and bring increased profits to shareholders. That means selling the disease. One study that came out last month said half the men in the US are infected with HPV, yet only “11 percent of men and 33 percent of women have been vaccinated.” This is a classic tactic in selling sickness: point out the incredible underserved population. The companies have already developed the vaccine, now they just have to get more and more people to think about the spectre of genital warts—and get governments to pay for it. As a parent, you might have had your daughter immunized with the HPV vaccine. I hope that went ok, but let me tell you, it hasn’t been ok for some parents. Did you know that the vaccine is highly controversial, and that, for example, the Japanese government withdrew its recommendation of the HPV vaccine back in 2013, citing serious vaccine-related adverse effects. You probably don’t know about groups in places like Spain, Denmark and France that are petitioning governments to remove the HPV vaccine due to what they see as a large number of young girls suffering serious adverse events following an HPV vaccination (e.g. headache, nausea, fainting, fatigue, loss of memory and numbness in their hands and legs). Public health authorities in the US maintain the vaccine is safe, yet as of December 2016 the Vaccine Adverse Event Reporting (VAER) system in the US lists 49,033 adverse events linked to the HPV vaccine and 300 deaths. Remember, these are associations, not proven causation. Experts almost always call adverse event reports made to regulators “anecdotal,” but does that mean we should ignore them altogether? Does that mean the vaccine will be perfectly safe for boys? Global concern over the many unexplained adverse effects of the HPV vaccine was so high that the European Medicines Agency ordered a review of the HPV vaccine. This extensive study eventually reported that it was generally “safe.” Unfortunately that EMA assessment is most certainly flawed, according to Dr Tom Jefferson, who works with the Cochrane Collaboration and Oxford’s Centre for Evidence Based Medicine. He understands why European countries were questioning the HPV vaccine’s safety, writing that “there is a possible association between exposure of young women to human papillomavirus (HPV) vaccines and two ‘dysautonomic syndromes’ (a collection of signs and symptoms thought to be caused by autoimmunity)—complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS).” There have been reports of girls developing weird autoimmune disorders and a range of other symptoms. Dr Jefferson has examined the EMA’s evaluation in great detail and found this “safety review” was hardly an independent assessment as it mostly relied on manufacturer-supplied data. This is like letting the kids mark their own papers. Meanwhile, that EMA report is cited by public health officials, including our own Provincial Health Officer Dr Perry Kendall, as proof of the vaccine’s safety. Of the HPV vaccine, he said in a news release, “Vaccine safety monitoring continues to show the safety of the HPV immunization,” adding that “it’s just as effective in preventing HPV-related cancers in males as it is in females, and the benefits are long-lasting.” I hope he’s right. But hang on, “long lasting benefits”? C’mon, even the highest-ranking doctor in BC doesn’t have any access to data on the long-term effects of these vaccines. No one does. Remember, soccer moms and dads, HPV is an incredibly common virus, which happens to spread mostly (but not always) through sexual contact, and more than 90 percent of people clear the virus on their own with no problem. You may find yourself asking: Why haven’t I heard about this before? Some of you might have caught wind of parts of the controversies, but the guiding hand of pharma’s marketing machine, their influence on the media, patient groups, physicians, researchers, and politicians is professional, thorough and mostly invisible. Given the many unanswered questions, you might wonder why the BC government is now interested in paying for the HPV vaccine for boys. Lori Cascaden, a spokesperson at the BC Ministry at Health, wrote me to say: “when a new or improved vaccine is approved for use, BC considers it for inclusion in the publicly-funded schedule using a number of factors to inform the decision, including: efficacy, burden of illness, cost-effectiveness, feasibility of delivery, and public acceptability.” Sounds good, except to say on all those factors, immunizing our boys with the HPV vaccine simply doesn’t pass muster. Me? I’d prefer if the Ministry just admitted what is really going on. Why don’t they tell us that despite the $2.2 million (plus “operational costs”) this decision will cost us, everyone who has a prominent opinion on HPV is in on the lobbying game. The Canadian Cancer Society, for instance, proudly displays Merck’s logo on its website and tells us that they, “along with 25 other health organizations, submitted a letter to BC Health Minister Terry Lake in early June requesting an expansion of BC’s vaccination program to include all genders.” Is it worth noting that in 2016 the Society received a one-million-dollar contribution from Merck, the maker of Gardasil, to create a new website about the latest scientific discoveries in cancer? So, soccer parents, you’ve got a few months to think about this decision and do some research. Try to steer clear of the HPV propaganda if you can, and remember, in this government where “pharma-friendly” should be the logo of the Ministry of Health, your boys are a really convenient way to transfer money to the pharmaceutical companies—which have also donated generously to the BC Liberal Party. Health policy is something we all need to consider as we head towards the May 2017 provincial election. Alan Cassels is a Victoria author and pharmaceutical policy researcher. He has written four books on the medical screening and pharmaceutical industry including the latest, The Cochrane Collaboration: Medicine’s Best Kept Secret.
  15. Policies friendly to the manufacturers of prescription drugs bear a lot of responsibility for the current opioid crisis. I WITNESSED THE EFFECTS OF THE OPIOID CRISIS first hand in November. It was a Sunday afternoon and my brother and I were driving from East Vancouver into Downtown. In the space of about five blocks along Hastings Street we saw no less than three clusters of fire engines and ambulances, their lights flashing while swarms of first responders scurried to administer to those overdosing in broad daylight. As we wove our way through the melee my brother and I looked at each other and said: Is this what the opioid crisis looks like in BC? Surely this is the most visible face of the crisis, but it’s also unfolding in middle-class homes as young people experiment and others manage chronic pain with some of the most powerful drugs on the planet. Back in April, as the Provincial Health Officer was declaring a public health emergency in BC, people were dying from overdoses at astonishing rates. They still are. As of the end of November, BC Coroner’s service reported 755 illicit overdose deaths for 2016 in BC. A Canadian Research Initiative report noted that “the number of pharmaceutical opioid-related deaths exceeds the number of deaths from motor vehicle accidents involving alcohol in BC.” The question we need to answer, especially given that these deaths often involve legally-obtainable, provincially-covered painkillers, is this: Who is responsible and how can we stop the mounting death toll? It’s worth thinking of the parable of the bridge. You know the old story where babies are spotted floating down a river, and a village is mobilized to jump in and save them one by one. The villagers become very busy saving babies from drowning, but it isn’t until someone asks, “How are those babies ending up in the river?” that a search party is sent upstream only to discover someone flinging them off a bridge. It’s pretty clear British Columbians are mobilizing to save those babies, yet some would argue we haven’t a clue how to mount an effective search party. Let’s be clear: Death by overdose is a very small but very noticeable part of a very large problem that is threatening entire communities. Some say political attention is happening now because it’s not just marginalized Canadians who are dying, but also young people from middle-class families who are consuming and dying from weapons-grade opioids. Andrew Weaver, the Green Party MLA from Oak Bay-Gordon Head, wants to know what is happening. “Why is it people are getting addicted? That’s a key thing.” But he also reports, “I’ve had constituents who have died—kids who come from decent homes. Those who are recreational drug users.” While there is certainly a criminal element linked to the current spate of fentanyl deaths, many researchers are focusing some blame at prescribing policies, as well as political leaders who, the researchers say, have been asleep at the switch. A November 2015 report from the BC Node of the Canadian Research Initiative on Substance Misuse states that “ultimately, prescribers are largely responsible for the burgeoning illicit market in pharmaceutical opioids that has developed on the streets of BC. In fact, the entry of organized crime groups into the manufacturing of counterfeit pharmaceutical opioids (which often contain fentanyl) to fuel the street market for illicit or diverted opioids is arguably a direct result of longstanding unsafe physician prescribing practices.” Dr David Juurlink, an opioid expert at the University of Toronto, told the Evidence Network that “with the benefit of 20 years of hindsight we have seen we’ve harmed patients and we have introduced into circulation millions upon millions of opioid tablets that have fallen into the wrong hands and it’s a direct result of our prescribing.” He also noted that “many of the companies who made these drugs have a role in the genesis of the problem—they have to face up to it.” He added that the drug companies “continue to advocate for the continued use of these drugs and, in some instances, have obstructed efforts to attenuate this crisis.” Many of the addicts turning to street-level drugs probably had their first taste of opioid from a doctor, a fact even the BC College of Physicians and Surgeons recognizes. A news release from June this year had Registrar and CEO Dr Heidi Oetter cut to the chase, writing that “physicians also play a role by over-prescribing opioids, sedatives and stimulants.” Tom Evans, a New Brunswick doctor told CBC News that “most people who try fentanyl have already tried many other prescription drugs.” He also said: “You don’t get to fentanyl without passing through codeine, OxyContin, MS Contin, Tramacet—you don’t get there without being exposed to the narcotics first—you have to have the gateway drug.” There’s clear evidence that when scripts for legal opioids run out, people turn to other places. Research in Canada and the US has found that most new heroin addicts turned to heroin after their supply of an opioid (maybe morphine or oxycontin) ran out. According to the National Institute on Drug Abuse, “Nearly half of young people who inject heroin surveyed in three recent studies reported abusing prescription opioids before starting to use heroin.” Yet the focus in BC doesn’t come close to tackling problems related to the behaviour of the pharmaceutical industry or the prescribing by doctors. Why is that? Perhaps one has to follow the money. IT DOESN'T TAKE A ROCKET SURGEON to see how close the BC Liberals are to the pharmaceutical industry. For example, in late November, a news release entitled “Transforming drug research and development in BC” announced that the BC Liberals tossed another $13 million to UBC’s Centre for Drug Research and Development (CDRD), which was on top of the previous $29 million they gave them in 2012 in order to support the centre’s goal of “bringing new drug therapies to the market.” This centre’s purpose, of commercializing drug discoveries, is basically to help industry make drugs that make money. As far as I can tell, the only new therapy that is being brought to market in BC (though not by the CDRD) in any enthusiastic way is naloxone, the antidote to help prevent death by opioid overdose. While naloxone saves lives, one cannot miss the massive dose of cynicism around the fact that some of the same companies selling fentanyl are also selling the antidote. How’s that for double dipping? While everyone welcomes any efforts to stop overdosers from dying, one might legitimately ask: “Where is the action to prevent the babies being tossed off the bridge in the first place?” To their credit, besides increased access to naloxone, the BC government has injected $10 million into an addiction treatment research and training centre, as well as set up a Joint Task Force on Overdose Prevention. In announcing this task force, the Premier said that they want to work with the feds to expedite safe injection sites, restrict the sale of pill presses, and limit access to the constituent ingredients of black-market fentanyl. All decent actions to deal with the supply, but what about the demand? And there’s still little help for those wanting off the drugs. MLA Judy Darcy, the BC NDP Health Critic, told me she attended a City of Vancouver forum on the fentanyl crisis. “We heard loud and clear that treatment and recovery has fallen off the table,” she said, adding, “We have no funded treatment programs in British Columbia.” Darcy said that treatment in BC is really only for those who can afford the immense cost (often $30,000 or more), and even then, many addicts need several expensive tries at rehab before they get to sobriety. The Liberals’ 2013 election promise of 500 treatment beds has failed to materialize, though they are now aiming to have them in place by March. Andrew Weaver characterized the BC Liberals’ mode of action as “all reactive, not proactive.” That could be, he surmised, due to the Liberals’ own addiction—to money. From his perspective, “the BC Liberals are beholden to their donors and they only listen to their lobbyists.” A quick search of the lobbying registry in BC finds that more than 20 percent of the lobbying in BC happens around healthcare; pharmaceutical companies are among the most active lobbyists in that sector. There are dozens of registered drug lobbyists in BC, many representing drug giants like Pfizer, Eli Lilly and Novartis, which make opioid painkillers. Since the late 1990s, drug manufacturers in Canada have underwritten the writing of pain guidelines, and paid “key opinion leaders” in the physician community to downplay the dangers of opioids. This helps explain why, globally, Canada is second only to the US in per capita prescription opioid consumption. In November 2016, six officials connected to Subsys, the company that makes prescription fentanyl in the US, were indicted on a range of charges, including conspiring to bribe physicians and offering kickbacks for getting them to prescribe their fentanyl-based pain drug. The extent to which this kind of thing is happening in BC is impossible to determine, because the BC Ministry of Health has no program in place that tracks physician payments by pharmaceutical companies. Three years ago the Vancouver Sun reported that drug companies and pharmacies donated $582,549 to the BC Liberals between 2005 and 2012, an amount that is 14 times what those organizations gave to the NDP. (During those same years, opioid prescriptions rose by around 30 percent.) Astonishingly, the BC Liberal convention this fall was underwritten by at least two drug companies and a chain drug store! Does all this drug money and influence work? According to Andrew Weaver, “There is no question that the BC Liberals are influenced by those with the deepest pockets.” The result is pro-pharma policies that have fuelled the opioid epidemic in BC. Since the mid-1990s, for instance, liberal prescribing of opioids can be linked to the message-crafting activities of the pharmaceutical industry that helped shape both patient perceptions of pain and influenced how doctors thought about the safety of these drugs. Here in Victoria, we’ve seen ongoing efforts to destroy independent research and evaluation, most spectacularly through the ongoing saga of the 2012 Ministry of Health firing scandal, including the suicide of one of the researchers. The estimated $100-million price tag for that fiasco, and the death of a culture of drug safety evaluations, has not yet ended as the government has punted this embarrassing problem to Ombudsman Jay Chalke. Programs that we had in place to monitor prescribing and to educate physicians have been scrapped by this government. The torpedoed research and evaluation branch of BC Pharmacare has never been resuscitated. Independent evaluators, like those at the Therapeutics Initiative at UBC, could be used to help document and evaluate opioid prescribing in BC, but they have been pushed to the sidelines. The College of Physicians and Surgeons new guidelines are attempting to crack the whip on opioid prescribing, but they may just end up driving even more people to the street to find the pain relievers they’ve become addicted to. Ultimately, we have the capacity to mount a search party and find out who is flinging those babies off the bridge. But with an election looming, don’t expect any serious attempts to stop the flow of opioids or to stand up to the culture of pharmaceutical industry largesse that continues to percolate through the Ministry of Health’s decision making. Alan Cassels is a Victoria author and pharmaceutical policy researcher. He has written four books on the medical screening and pharmaceutical industry including the latest, The Cochrane Collaboration: Medicine’s Best Kept Secret.
  16. A local doctor helps wind back the harms of too much medicine. IT'S PRETTY EASY TO FEEL WORRIED about health care. Doctor shortages. Unvaccinated children. Fentanyl overdoses. Neglected seniors. Wait lists. Zika virus. The things that concern us about our health and medical care make for a long and overwhelming list. And the one-word response to the slow and sometimes inept nature of our health care system always seems to be “More.” We need: more doctors, more nurses, more vaccinations, more operating rooms, more long-term care, more overdose prevention medications, more funding, more, more, more. At the same time, and out of the glare of marquee health headlines, there’s a growing movement that sees many major problems in health care in another light. This movement maintains that a lot of health care turmoil is due to medical excessiveness—particularly the overuse and inappropriate use of medical interventions. It warns that for people who are otherwise healthy, overdiagnosis and overtreatment are real and worrisome problems and despite some clear underserviced areas of the medical system, there is a need to wind back the harms of too much medicine. Currently, pockets of resistance are springing up around the world attempting to put the brakes on medical overuse, overdiagnosis, and overtreatment and there are even international conferences of resistors meeting to discuss what to do about this problem. One of the resistors is Dr. Jessica Otte, a physician who took a small break from treating her mostly elderly patients in Nanaimo to go to Barcelona last month to present at the annual Preventing Overdiagnosis conference. She was one of over 400 researchers, health policy makers, clinicians and consumer activists who came together to discuss, debate and ultimately try to strategize ways to rein in the worst excesses of medicine. Otte exudes enthusiasm and energy, the kind of articulate and thoughtful doctor you’d want at the bedside to help sort out your elderly grandmother’s medications. While she could have come to Barcelona to talk about what she does everyday—overcoming the challenges of reducing the medication burden of frail seniors, for example—this time she facilitated a workshop about the many organizations around the world that are working to prevent overdiagnosis and overtreatment. (In the interest of full disclosure, I was in Barcelona, too, working on a different campaign and Otte invited me to be part of her presentation, though I assure you, she did all the work.) As I listened to her talk about the dozens of groups around the world tackling overdiagnosis, I looked out over a packed audience that included people from every country in Europe, Canada, the US, and even China. It struck me what a global concern this has become. Then something else dawned on me: The person who probably has the best grasp in the world on the global movement to prevent overdiagnosis lives in Nanaimo. Now, how cool is that? (See Dr Otte’s website www.lessismoremedicine.com.) Among the many organizations and researchers tackling overdiagnosis, cancer screening is a particularly strong focus. This is due to the fact that although we once believed that early detection was key to fighting aggressive cancers, it hasn’t borne out. When you screen healthy populations for cancers you inevitably capture a large numbers of people with “pseudo disease.” Through an X-ray or blood test you may capture something—a shadow, a nodule or something else unusual—that will be labelled as cancer, but will never go on to hurt the person. Yet the very nature of the testing means you’ll turn that person into a patient, and treat them anyway, sometimes with disastrous consequences. In Barcelona over three days there were whole workshops discussing just the overdiagnosis that comes with particular types of cancer screening. For example, one group of researchers from Korea, experts on thyroid cancer overdiagnosis, presented a study that showed when thyroid cancer screening took off in Korea in the early 1990s (because there was a new ultrasound test paid for by the government), the rate of thyroid cancers grew by 1500 percent over the next 20 years. The ultimate kicker: Despite the near “epidemic” rate of people in Korea being told they had thyroid cancer, the actual death rate remained unchanged over that nearly 20-year span. Which is to say, all the screening, treating and surgery on those unsuspecting Korean patients didn’t change one iota the number of Koreans who ultimately died of thyroid cancer. This is one example, and there were oodles of them at this conference, of how putting a screening program under strong scientific scrutiny can reveal a motherlode of pseudo disease, the treatment of which causes untold suffering to no overall benefit. Barcelona saw numerous workshops around the two most popular yet most overdiagnosed types of screening in Canada: Prostate cancer screening and mammographies for breast cancers. It’s clear that both those types of screening programs are undergoing a deep global rethink. Countries like France have pledged to “radically redesign” its mammography screening programs because of all the harms related to overdiagnosis. Just last month, the storied New England Journal of Medicine published a damning study of mammography which found that women were more likely to be overdiagnosed with breast cancer screening than to find a tumour that was going to go on to get large and possibly hurt them. But perhaps the poster child for overdiagnosis is the PSA test, a blood test which is used as a screening test for prostate cancer. For over two decades, men have been told that, once they reach the age of 50, they should get a PSA test. A study last month in the New England Journal of Medicine showed how bad that advice is. It looked at a study of more than 1,600 men in the UK, aged 50 to 69, diagnosed with localized prostate cancer (via a “high” PSA or prostate specific antigen reading). Many things could affect a PSA reading, but once you get a high reading and are diagnosed with prostate cancer, you are advised to get surgery, have radiation, or just “do nothing” and wait and see what happens. The researchers did a randomized trial. Dividing the men into three groups of roughly equal size, the first group were given radiation, the second had surgery, and the third were given “active monitoring,” which is to say the last group essentially had no treatment whatsoever. The trial followed these three groups of men for 10 years, and found that 99 percent of them were still alive, regardless of which path they were on. Those men who had surgery and radiation didn’t live any longer than those who avoided such treatment. And they didn’t live any healthier either, as some of those treated faced the adverse effects of the treatment. Sadly, there are thousands of men in Canada and several million in the US who have been made incontinent or impotent due to the overdiagnosis that comes with the last 20 years of PSA testing. This is the real face of overdiagnosis and the problem is that most men may never be told that they are about to get a life-altering test. The conversation they needed didn’t happen. Of course, there are few absolutes, and appropriate health care is really about having the right conversation. Otte spoke to me about the campaign she is most familiar with, the Choosing Wisely Canada campaign originally started to foster discussions between physicians and patients around unnecessary and harmful tests, treatments, and procedures. Doctors themselves recognize the problem, and one study in the US found that 75 percent of doctors report prescribing an unnecessary test or procedure at least once a week and about half the doctors surveyed said that patients are simply receiving too much medical care. Otte tells me: “The broad idea is that more is not always better in health care; when someone is sick, they need help, but when they are healthy we should encourage them to stay that way and not try to turn them into patients.” She pauses to add, “If we would address overuse, harm, and waste in the medical system, we will have the resources to tackle areas of significant need, like treating poverty, food insecurity, and inactive lifestyles.” I asked for another example of where she sees waste and overdiagnosis. Without a pause she points to a single recommendation: “Do not screen for thyroid function in a patient who doesn’t have any symptoms.” Why? “Well,” she says, “we often over-order that test and are surprised when the result is high or low. We label people with minor abnormalities as having a disease. Attaching labels and diagnoses to people is not always helpful, as for the rest of their life they can never feel truly healthy again.” Jessica Otte, like many of her colleagues in Barcelona, recognizes that part of the problem with overdiagnosis is the strong motive of health care workers to do good, to not miss anything. But doing something can be more harmful than doing nothing beyond having an educating, reassuring discussion. Alan Cassels is a Victoria author and pharmaceutical policy researcher. He has written four books on the medical screening and pharmaceutical industry including the latest, The Cochrane Collaboration: Medicine’s Best Kept Secret.
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