Jump to content

Alan Cassels

Moderators
  • Content count

    8
  • Joined

  • Last visited

About Alan Cassels

  • Rank
    Newbie

Recent Profile Visitors

The recent visitors block is disabled and is not being shown to other users.

  1. Alan Cassels

    Spinning the wonder drugs

    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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. Alan Cassels

    A pox on their house

    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.
  7. 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:
  8. 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.
×