Billions wasted on cholesterol myth

DRUG BUST
by Alan Cassels

The alleged benefits of lowering our cholesterol have never materialized and we have wasted tens of billions of dollars over the last two decades, deluded by a myth. It’s time to drop that myth.

Though it may appear to my readers that I have cried wolf far too often on cholesterol-lowering drugs, I’m prepared to howl at the moon at least one more time. If you’ve read my columns over the last decade, you’ve seen me rant about the futility and absolute waste involved in our society’s collective obsession with cholesterol and our foolishness in swallowing a paradigm promoted by the pharmaceutical industry and the specialists in their employ. The alleged benefits of lowering our cholesterol have never materialized and we have wasted tens of billions of dollars over the last two decades, deluded by a myth. It’s time to drop that myth.

Ever since the early 1990s when the first cholesterol lowering drugs were being introduced to the market, no one had really ever heard of “high cholesterol” and certainly no one was going to their doctor just to get something checked that they never knew existed, that they couldn’t feel and which was responsible for zero symptoms. Then along came the blockbuster statins and physicians followed guidelines that told them a patient’s cholesterol level was an important risk factor for death by coronary heart disease (CHD). The hypothesis said that if you measured and lowered the cholesterol of patients deemed “high risk,” those patients would live longer and avoid dying from heart attacks. So how’s that working out?

Not so well, according to a study published in March of this year that probably delivered some of the boldest evidence yet and which should absolutely trash our enthusiasm for lowering our cholesterol. A European research team led by Dr. Federico Vancheri of Italy looked at statin consumption across 12 countries in western Europe between the years 2000 and 2012. During that time, the use of statins increased dramatically all across Europe – as well as in North America – yet his team wanted to know how this increase was reflected in the numbers of people who died of heart attacks. After all, with statins being used by tens of millions of patients, how many fewer heart attack deaths were there?

Here’s the good news: in all countries over that 12 year period, there was lower CHD mortality in 2012 compared to 2000; that is to say, fewer deaths by heart attack. The drop in those numbers is thought to be attributed to a range of things: healthier diets, more exercise, lower rates of smoking, better treatment once you had established heart disease, and so on.

However, things didn’t look so good when you looked at individual countries. The researchers found that “when the different countries were compared, there was no evidence that higher statin utilization was associated with lower CHD mortality, nor was there evidence that a high increase in statin utilization between 2000 and 2012 was related to a larger reduction in CHD mortality.” In other words, despite all the statin prescribing, it had no effect on the one thing we expected to see: lower rates of heart attacks. This kind of research is not exactly new. There was an earlier Swedish study that showed the differences in a large sample of municipalities where the amount of statin prescribing had zero effect on the rate of heart attacks or CHD death.

Despite this kind of bad news for the statin manufacturers, the world is not exactly mourning the loss of a very costly – and now proven wastefully ineffective – pill. Just last month, many of us watched in horror as we witnessed a high-quality source of health information – the US Preventive Services Task Force (USPSTF) – come out with the astonishing recommendation that statins should be used by even more of us.

In their analysis, the USPSTF amassed a massive amount of data from over 70,000 patients from 19 different trials. They wrote that low-to-moderate-dose statins should be given to “adults aged 40 to 75 years without a history of cardiovascular disease (CVD), who have one or more CVD risk factors and a calculated 10-year CVD event risk of 10% or greater.” Practically speaking, this means tens of millions more Americans were offered statins.

Sounds good, right? Not so fast. Remember, the people they are recommending take statins are basically healthy, middle-aged people, folks with no established heart disease, 90% of whom will live perfectly happily without a heart attack or stroke over the next 10 years. These are NOT sick people perched on death’s doorstep.

So, what’s up? It always surprises me when an otherwise reputable and trustworthy source gives absurd advice, especially given all the statin scandals and shenanigans we’ve seen over the last two decades.

In case you don’t believe me, here are some key reasons we should ignore the advice to give more statins to more people, as the task force recommended. I must acknowledge Drs. Rita Redberg and Mitchell Katz who wrote a scintillating editorial on this USPSTF recommendation and whose arguments I am partially summarizing here.

The first thing to know is that the body of studies examined by the USPSTF is tainted, as it included many people taking statins for ‘secondary’ prevention – for example, people with established heart disease and hence considered at much higher risk. You cannot extrapolate how they fared on statins to healthier people without established heart disease.

The second thing is that the evidence they looked at didn’t contain the kind of detail we need. The USPSTF didn’t examine what we call primary data, which are the actual reports from the subjects in the statin trials. Without actual patient reports, we’re only getting the results of what someone has chosen to summarize for us. Sorry, that isn’t good enough. Also, if you only examined the published reports of statins, you are being naive because we know that most of the trials on statins were done by the manufacturers and they have a tendency to bury negative data. The result? An overly rosy picture of the effects of statins.

Thirdly, there was a major bit of missing information in those data, specifically what we call “all-cause mortality.” Only half of the trials they looked at reported how many patients died from cardiovascular causes, heart attacks and strokes. The problem with missing data is you are only getting half the picture so you end up concluding the drugs are safer than they actually are. You wouldn’t conclude how rich you are by only looking at your assets, would you? No, of course not. You need to know your liabilities and debts as well. Same with statins. Without both sides of the equation, you are at risk of being misled.

We need to remind ourselves of one key thing: people of ‘low risk’ may have very little chance of benefiting from a statin, but will have an equal chance of harm. In this group of healthy, low-risk people recommended to take statins, the benefit/harm math shifts and they are more likely to be hurt than helped.

Overall, the danger of recommendations like these is that more people will be convinced they are at high risk when they aren’t and take a drug that is unlikely to help because it is only proven to help those with established heart disease. We have known for a long time that statins can cause muscle aches, weakness, fatigue, cognitive dysfunction and an increased risk of diabetes. Why would you want to take your chances?

Maybe all the statin denialism is just part of the post-truth world and people tend to believe what they want to believe despite the overwhelming evidence in the other direction. Are you a ‘low-risk’ person who still wants to take a statin? Then you should have to pay for your denialism.

Statins are currently the fourth most costly drug to BC’s Pharmacare budget, and with over 400,000 British Columbians consuming statins every day, costing taxpayers and patients about $100 million per year, couldn’t we just admit the experiment is over, it was a failure and it’s time to move on?

Alan Cassels is a drug policy researcher and writer. In each of his past four books, the latest which is called The Cochrane Collaboration: Medicine’s Best Kept Secret, he has written about statins. Follow him on twitter @AkeCassels www.alancassels.com

The looming epidemic of overdiagnosis

Where are the leaders in eliminating waste in health system spending?

DRUG BUST
by Alan Cassels

Lately, I’ve got overdiagnosis on my mind.

Currently, we’re living through a perceived doctor shortage in BC, a crisis affecting as many as 600,000 British Columbians. In 2010, the governing BC Liberals promised that, within five years, everyone in BC who needed a family doc would get one. They even made this promise part of electioneering in 2013. How’s that plan worked out?

Well, it hasn’t. A few people may have been helped by a dating service set up to connect doctors and patients, but it was universally considered a bust. Despite promised government fixes, we have about 100,000 more people today without a doc they can call their own than we did five years ago. In early 2015, the government basically acknowledged it was a failure.

Read moreThe looming epidemic of overdiagnosis

Leave our prostates alone

Healthcare must engage in a wider discussion about preventive medicine

DRUG BUST
by Alan Cassels

• “Preventive medicine displays all three elements of arrogance…Aggressively assertive…Presumptuous…Overbearing.”

Dr. David Sackett wrote those words over a decade ago in a neat little column in the Canadian Medical Association Journal. He was, in this case, talking about hormone replacement therapy, after the publication of one of the world’s largest studies in preventive healthcare. The results of the Women’s Health Initiative showed that giving estrogen and progestin to healthy women going through menopause, on the assumption that this was vital preventive medicine, did not protect them from cardiovascular disease. In fact, it increased rates of some forms of cancer, heart attacks, blood clots and strokes. In trying to preserve and protect health, the recommended therapies were harming women. On a massive scale, I should add.

Read moreLeave our prostates alone

Hoodwinked by the diabetes industry

Drugs to lower blood sugars don’t do much for your health

DRUG BUST by Alan Cassels

 

Portrait of columnist Alan Cassels• In the last five years in British Columbia, taxpayers – that would be you and I – spent over $100 million on drugs and insulins for type-2 diabetes through our Pharmacare program. In addition, people in BC probably spent another $200 million out of their own pockets and the pockets of our employer-sponsored drug plans on diabetes treatments. Add to that the costs of all the doctor’s visits and the diabetes paraphernalia – including glucose test strips, lab tests and so on to keep blood sugars monitored – and two things are clear: this is one expensive disease and it creates a huge amount of medical busywork.

Maybe the hundreds of millions of dollars we’re spending on diabetes measurements and treatments is well spent. Surely, it would be if we could be sure people are getting the drugs they need so they don’t suffer heart attacks and strokes and the more serious complications of diabetes. But can we be sure of that? Hmm, probably not.

There is one particularly strong theme you’ll hear when doctors discuss diabetes: that if you have it, you are increasing your cardiovascular risk, for example, your risk of a heart attack and stroke, both which could be fatal. People with type-2 diabetes have difficulty processing sugar, a condition that is described in guidelines as a “complex chronic disease characterized by hyperglycemia due to defective insulin secretion, defective insulin action or both.” Insulin is produced by the pancreas and regulates both the breakdown and movement of glucose, which is critical to maintaining blood sugar levels within normal ranges. The good thing is if you’ve got too much sugar floating around in your bloodstream, there are many drugs to lower those sugars.

But if you read no further in this column, here’s the punch line: Most of the money we spend in this province on drugs to reduce blood sugars in type-2 diabetics achieves almost nothing. While the drugs can be extremely effective at lowering blood sugars – and so it appears they are doing something useful – they will do almost nothing at lowering serious health risks, such your chances of a cardiovascular event like a heart attack or stroke.

Don’t believe me? The latest newsletter put out by the Therapeutics Initiative at UBC, which assesses clinical studies of drugs, concluded, “Glucose lowering medications for people with type 2-diabetes are widely prescribed in Canada despite having been approved by Health Canada without credible evidence that they reduce mortality or major morbidity.”

The newsletter says a little bit more, but let’s consider the implications of this statement for the average person. A man named John is in his mid 70s and has lived all his life without any consideration that he may be ill. He has no symptoms, but after being sent for a routine blood test he is told he is now a diabetic and needs to take drugs and maybe insulins to control his disease. More specifically, he is told he has a “high” reading on his hemoglobin A1c test, (HbA1c), also known as a glycosylated hemoglobin test. This is a marker of how well one’s blood sugar has been controlled during the previous two to three months. If it is much higher than ‘normal’ the doctor will look for any signs of kidney or eye damage or damage to blood vessels in the legs, all of which are considered “microvascular complications” that are linked to diabetes. The next step is he’s put on a drug called metformin. This is how things usually roll.

In BC, the government sponsored diabetes care guidelines say that any hemoglobin A1c greater than 6.5% constitutes a diagnosis of type-2 diabetes. Most experts say that 7 percent is the magic threshold and keeping the HbA1c level below 7 percent will lead to fewer diabetes complications (eye or kidney disease). But again, this is controversial. Even Consumer Reports on Health in the US says there is no definitive proof that keeping HbA1c under 7 percent prevents heart disease or premature death and they remind us that most of the studies of HbA1c are short, a year or less. The upshot? Who knows what the long-term effects of driving blood sugars down below this level are?

But we push on. Why? Because John’s HbA1c is closer to 8.5 and the guidelines say it should be 6.5. The standard advice for anyone identified as having a “high” HbA1c level is to lose weight and control one’s blood sugars through diet and exercise. Controlling one’s diet – especially cutting back on carbohydrates – and getting more exercise can be the closest thing to a cure and the good news is you don’t have to be a marathon runner to get adequate exercise. In fact, daily walking is enough for many people to stave off diabetes, push their HbA1c down and avoid the worst complications of the disease.

Have you ever noticed how much activity there is around a disease if the drug industry can produce profitable products that appear to do something for it and can be sold for daily use over the long term? Well, type-2 diabetes is the poster-child for a drug-friendly disease, and you can imagine the absolute cornucopia of drug treatments for type-2 diabetics that are out there.

Diabetes is the marketer’s ideal condition as it allows a lot of profitable busywork around measuring blood sugar levels, altering those levels with drugs, and measuring again. Trying to get your blood sugars down to 7 or 6.5 percent makes for very good activity to distract people from the fact the drugs are doing almost nothing to alter the underlying course of the person’s diabetes.

Like most newly diagnosed type-2 diabetics, John first gets prescribed two of the oldest and cheapest drugs, metformin and glyburide. The real big money for the drug companies, however, comes from the newer treatments, including more than a dozen on-patent and much more expensive drugs that lower blood glucose. These include the Gliptins: sitagliptin (Januvia), saxagliptin (Onglyza), linagliptin (Trajenta), alogliptin (Nesina); the Tides: exenatide (Byetta), liraglutide (Victoza), albiglutide (Eperzan) and dulaglutide (Trulicity); and the Flozins: canagliflozin (Invokana), dapagliflozin (Forxiga) and empagliflozin (Jardiance).

Collectively, Canadians spend nearly $750 million per year on prescription drugs that lower glucose, an amount that works out to about 628 prescriptions per 1,000 people, about the same volume we consume in antibiotics. But how many drugs does one need to get those numbers down? In BC, about 100,000 people take a single drug (mostly metformin) every day to lower their blood glucose. But it doesn’t stop there. Nearly 65,000 BC residents take two or more diabetes drugs and nearly 30,000 take three or more.

A 2013 review from the Cochrane Collaboration found that ‘intensive glycemic control’ – trying to keep the HbA1c at or below the 7 percent mark – did not reduce rates of cardiovascular death, non-fatal stroke and end-stage kidney disease. What was cruelly ironic in that study – a meta-analysis of nearly 30 studies on the same question – is that patients who were subjected to intensive glycemic control had more serious adverse events, including severe hypoglycemia (which often ended in hospitalization). In other words, the taking of multiple drugs to drive one’s blood sugars lower and lower seems to be a fool’s game.

Who stands to benefit from the war on glucose? Just follow the money, I say. Driving for lower and lower blood sugars is big money in Canada. In BC alone we spend hundreds of millions of dollars chasing blood sugars into absurd territory. We allow the pharmaceutical companies to write the guidelines and our own doctors to be ‘educated’ about those pharma-funded guidelines.

Hoodwinked by the diabetes industry, we spend, as a society, tons of money treating this so-called risk factor called hemoglobin A1c, yet all that money does almost nothing to save lives or help people live longer. We should be spending healthcare dollars that purchase health. This diabetes scam just gives more profits to the drug companies while giving us nothing in return.

Alan Cassels lives in Victoria where he studies and writes about the pharmaceutical industry, disease mongering and overdiagnosis. His latest book is The Cochrane Collaboration: Medicine’s Best Kept Secret.

The growing backlash against medical guidelines

Doctors need to “show more spine”

DRUG BUST by Alan Cassels

 

PhotoHeadshotAlanCassels

• The disease-creation machine continues to creep forward, threatening to consume even more of us healthy people. Consider these recent news items:

– Americans, we are told, are facing an epidemic of heart disease. New cholesterol guidelines suggest that virtually the entire elderly population of Americans are “at risk” of having a heart attack and hence even more of them should consider taking cholesterol-lowering statins.

– Norwegians, among the healthiest people in the world, are also, apparently, facing an epidemic of cardiovascular disease. A recent European guideline suggested most Norwegians over 25 would be defined as ‘high risk’ of cardiovascular disease. If Norway were to take this guideline seriously, it would drain the country’s entire primary health care budget.

– Americans, the experts tell us, are suffering an epidemic of osteoporosis. A new US osteoporosis guideline says that 72% of women over 65 are considered ‘diseased’ – a number which rises to 93% for those over 75 years old – and hence in need of drug therapy.

What is going on here?

Clearly, the only real ‘epidemic’ is the growing phenomenon where risks for disease are being turned into diseases, in and of themselves. In this racket, ‘high’ blood pressure, elevated cholesterol, low bone density, fluctuating blood sugars, high eyeball pressure and low testosterone, among other things, become worrying signs of chronic, lifelong conditions that demand attention and medication. As I’ve said in the past, “If you want to know why pharma is increasingly targeting healthy people with ‘preventive medicine,’ it’s because that’s where the money is.”

One thing all these risks-as-disease models have in common is they are shaped and supported by clinical practice guidelines. In these guidelines, doctors are told to measure their patients’ parameters. If your measurements are outside some preset levels deemed ‘high risk’ by the expert guidelines, you know what that means: more frequent trips to the pharmacy. The main downside of guidelines is they slap labels on people who aren’t sick and instill in physicians the constant idea their healthy patients are really disease-ridden.

But this is a good news story and if you haven’t sensed it, there’s a rising backlash against medical guidelines, mostly led by doctors, researchers and even some patients outraged at what they see going on. These rebels have a right to be angry because the guideline-writing process is highly flawed and biased, created mostly by experts who see particular body parts in isolation – as if you were nothing but a hip, a liver or a pancreas. The guidelines are foisted on our doctors and treated as inviolable even though they are frequently corrupted by conflicts of interest so deep it’s no surprise they are at the heart of pharma’s marketing apparatus. Seems to me the only ones who like guidelines are the drug companies that fund them and the experts that participate in writing them.

Certainly, our family doctors have many types of illnesses to deal with and staying on top of changes in recommended treatments is difficult. Some guidance is clearly valuable if it helps inform doctors on new and better ways to treat people, but if we allow guidelines to widen disease definitions and dictate what patients must do to avoid potential future illnesses, we are in big trouble.

A colleague of mine at UBC, James McCormack, has a good eye for when disease definitions are being widened, and he tells me many guidelines are not a useful synopsis of the best available evidence. He says they rarely consider the most important thing: the preferences of the patient. I’ve often heard him ranting about guidelines in lectures, yet he has recently taken his rants to the next level – creating a music video (Google: James McCormack and The End of Guidelines) – which will leave you with little doubt as to what he and many of his colleagues around the world think of the present state of guidelines.

James likes to say guidelines are “thresholds for treatment” when what they need to be are “thresholds for discussion.” In other words, if a guideline is suggesting treating a person for a certain set of risk factors, this should be a signal for the doctor and the patient to start discussing those risks and the likelihood medications could help (what they call “shared decision-making”).

If you are told you have ‘risk factors’ for a future bad thing like a broken bone or a heart attack, you need to understand the magnitude of the risks. If I have a two percent chance of having a heart attack in the next ten years, that’s a very different picture than if the doctor tells me I have a 30 percent chance. And such information is vital because once understanding the risk, the next important thing is that the doctor and patient need to know how much a ‘guideline-recommended’ drug is likely to reduce those risks or potentially harm you. And you can then decide if it’s worth trying the drug, paying for it, and possibly facing annoying side effects.

A big part of the problem with guidelines is they exploit ambiguous definitions of disease. In the osteoporosis world, there are myriad different ways “vertebral fractures” are defined. These tiny cracks in the spine that tend to occur – mostly as people age and typically aren’t even felt – can be discovered on x-ray. But once discovered, does that mean you have to start taking a drug for the rest of your life?

Here’s how this maps out: If you take 100 asymptomatic older people (i.e. those who don’t have any pain or other symptoms related to their bones) and then x-ray all their spines, depending on what criteria you use, either three or 90 of them will be defined as having a “fracture.”

Osteoporosis guidelines – written mostly by experts with ties to osteoporosis drug makers – basically assert that if you discover one fracture, the goal becomes to avoid a second one (what they call ‘secondary prevention’). So if you x-ray Grandma’s spine – she had no idea she had these age-related vertebral fractures – you’re likely to make her worry and you start feeding her osteoporosis drugs. The guideline says, “A vertebral compression fracture signals a patient at high risk of subsequent fractures who should be managed appropriately. Vertebral fractures have debilitating consequences and even increase the risk of death.”

Since Grandma is old, she’s already at an ‘increased’ risk of death so labelling her as having a ‘high risk’ of a future fracture is just a label to get her to start swallowing more drugs. What makes this such a scam is that the bone-targeting drugs she’ll get prescribed won’t do anything to make her feel better or live any longer. This is so wasteful and so wrong on so many levels.

Among those riding a wave of rebellion against osteoporosis guidelines are a group of orthopedic surgeons in Helsinki who believe it’s time take a stand against crazy guidelines, and they want to start a conversation in the medical community. Since the definition of ‘vertebral fracture’ is being exploited, they say family doctors should stand tall and #show some spine on how vertebral fractures are defined. Not only do they want guideline writers to stop recommending stupid things based on shaky definitions, they want doctors to talk to their patients about so-called under-recognized, undiagnosed and untreated “vertebral fractures.”

Drug industry-sponsored guidelines and the doctors paid to write them should be exposed and challenged. And while waiting for the revolution, there is one thing you can do: as a potential ‘patient,’ you, dear reader, need to do your part and not so easily accept a new disease label. If you’re already healthy, a new disease label is unlikely to make you healthier.

These conversations seem long overdue. If our doctors are coming at us with new disease labels and the drugs that go with them, we should all hit the ‘pause’ button. We all need to have ‘the talk’ when it comes to how biased and unhelpful guidelines can be so we can avoid becoming a new patient.

Alan Cassels is a drug policy researcher in Victoria and the author of the new book called The Cochrane Collaboration: Medicine’s Best Kept Secret.

Concocted war on drug industry another Wag the Dog

BC Liberals can’t afford a real war against Pharma so they’ll fake one

 

DRUG BUST by Alan Cassels

Portrait of columnist Alan Cassels

• In the 1997 political satire film Wag the Dog, Anne Heche, playing an advisor to the US president, turns to Robert De Niro, another presidential aide and whispers, “We can’t afford a war.” De Niro waves his hand and replies confidently, “We’re going to have the ‘appearance’ of a war.”

The two are on a plane enroute to Los Angeles to recruit a famous Hollywood producer, played by Dustin Hoffman, whom they convince to work for them in constructing a fictional war. The sitting president of the US is caught up in a sex scandal 11 days before an election and, to distract the public’s attention, his advisers concoct a war with Albania. The De Niro character lays it out to Hoffman, waving his hands like a conductor: “It’s not a war, it’s a pageant. We need a theme, a song, some visuals. It’s a pageant.” The ensuing drama is ripe with scintillating satire, showing how craftily political operatives can manipulate the public’s attention and otherwise shape a narrative that can have a huge influence on world events – and elections.

How does this have anything to do with pharmaceuticals and drug policy?

Well, I found myself riffing on Wag the Dog when I saw a mini skirmish erupting between the BC Ministry of Health and the association of the Canadian brand-name drug industry known as Innovative Medicines Canada. This pageant included predictable talking points from astroturf activists and lobbyists berating the BC government and our Minister of Health while exhibiting unconvincing fearlessness.

If this was a war, I’d seen it before. But back then it was the real deal. In the mid 1990s, a newly elected NDP government in BC brought in one of the most radical and profit threatening changes the drug industry had ever seen in North America – at a time when ministries of health were embracing this new thing called Evidence-Based Medicine, where groups like the Oxford-based Centre for Evidence-Based Medicine, the Cochrane Collaboration and BC’s Therapeutics Initiative were being established. Basing policy on evidence instead of expert opinion allowed BC policymakers to consider Reference-Based Pricing to help reign in runaway drug costs.

Reference pricing was so simple a school child could understand it: if there was a bunch of products in a class of drugs that generally worked the same way – were ‘therapeutically equivalent’ – the government would pay for the cheapest one, the ‘reference’ drug. If you wanted a more expensive drug, you paid the difference. If the cheaper reference drug didn’t work for you, your doctor could ask PharmaCare for “Special Authority” and 95% of the time they were approved. The policy was a no-brainer and mirrored how many people shop: if there is no qualitative difference between competing products, why not buy the cheapest one?

By the end of the 1990s, Reference Pricing in BC covered five drug classes, including drugs for arthritis, ulcers, angina and blood pressure. Independent evaluations carried out by researchers found the policy saved the BC taxpayer about $44 million the first year in full operation, with no adverse impacts on health. With a provincial drug budget just over $400 million, this was a serious saving, yet the ensuing war between the BC government and the drug companies was a full-on, knock’em out fight.

For weeks, full-page ads ran in the Vancouver Sun and the Globe and Mail, paid for by the Pharmaceutical Manufacturers’ Association of Canada and the Canadian Association of Retired Persons. They featured a sorry looking senior helplessly staring into her medicine cabinet under the headline, “The Provincial Government wants to change your medication.” The Ministry responded in the press with its own ads and the media went crazy covering the story. One Vancouver Sun headline read, “Minister condemns drug manufacturers. Greedy multinational firms trying to terrorize British Columbians.”

Documenting this as a researcher was like getting a PhD in pharmaco-political propaganda. The BC Liberals listened to the lobbyists’ propaganda and promised to get rid of Reference Pricing if elected, which they were in 2001, helped by hundreds of thousands of Pharma money. After taking power, the Liberals commissioned several evaluations of the policy, which showed it was a great way to save money in the drug budget. Yet the policy was never expanded. We researchers knew of other drugs taxpayers were paying far more for than they needed to, yet the BC Liberals refused to expand Reference Pricing. The next class of drugs to be referenced – the cholesterol-lowering statins – was a big-ticket item when most of them were still under patent. Referencing them back in the 1990’s would have saved BC about $50 million per year. The Liberals refusing to implement this policy capable of saving $50 million a year for 16 years is an $800 million gift to the pharmaceutical industry. No wonder the drug companies were such avid donors to the BC Liberal party.

In the intervening years, other pro-Pharma policies under a BC Liberal government were shockingly generous to drug companies. In 2003, the Liberals created what they called “Fair PharmaCare,” which tied a citizen’s drug coverage to their income, proving to be a $100 million per year bonanza to the drug companies, right out of the pockets of BC citizens. Instead of ‘managing’ drug cost growth, the Liberals took the cowardly way out: shifting the cost growth onto consumers.

Perhaps the most blatant gift to Big Pharma was a 2007 commissioned review of PharmaCare designed to formulate recommendations on reform. The resulting Pharmaceutical Task Force was so stacked with drug industry executives and cronies, the recommendations were ridiculously generous to the drug companies. And then in 2012, we had the PharmaCare firing scandal, which destroyed the government’s own capacity to carry out proper drug safety research in this province, another massive gift to Big Pharma.

Fast forward to 2016 and an election looming; what do we see? The Liberals, to demonstrate how tough they are, dust off Reference Pricing, in the spirit of a wag-the- dog gimmick. This distraction is supposed to extend Reference Pricing to statins, angiotensin receptor blockers (for high blood pressure) and PPIs (proton pump inhibitors) for heartburn, but the savings, touted to be $9 million per year, are a drop in the bucket.

The drug industry has also played its dutiful part in this charade by launching a lobbying campaign asking BC citizens to write their MLA, the Premier and the Health Minister to complain they are being denied access to “world class” drugs. Astroturf activists in BC’s Pharma-funded Better PharmaCare Coalition are also pretending outrage and have weighed in on the debate too.

Terry Lake, our Minister of Health, told the Tyee he’s not a victim of lobbying by pharmaceutical companies. Really? Sorry, Terry, your whole government over the past 15 years has shown itself to be easily lobbied by the drug industry. We’ll know you’re serious about controlling drug costs when we see full-page attack ads in the Vancouver Sun. Until then, it’s a pageant.

A concocted war on the drug industry surely benefits the BC Liberal Party, which is desperate to prove it’s not in the pockets of the pharmaceutical industry. Historically, the drug companies that make up Innovative Medicines Canada are among the Liberals’ biggest donors. They are getting the government policies on pharmaceutical policy that they have bought.

I wonder what would happen if the Ministry brought in real, serious drug cost control policies such as halting the overprescribing of antipsychotic and diabetes drugs and oodles of other unsafe, and often useless, treatments? A government serious about playing hardball with the drug companies could probably save $300 million or more a year in BC and here’s the kicker: the health of the population would likely improve!

Just like in Wag the Dog, maybe the BC Liberals know they can’t afford a real war so they’ll just fake one.

Come election time, I’m hoping BC citizens can tell the difference between a government that has the cojones to take on the drug industry and one that is only faking it.

Alan Cassels is a drug policy researcher in Victoria and the author of the new book called The Cochrane Collaboration: Medicine’s Best Kept Secret.

Pharma’s predatory scare tactics

They have no place in Canadian universities

DRUG BUST by Alan Cassels

PhotoHeadshotAlanCassels• Wandering the halls of a college or university campus can be enlightening in seeing how the pharmaceutical marketing machine is insinuating itself into the lives of young people.

Last month, while giving a public lecture at the University of Victoria, I spotted a glossy poster entitled, “Reasons Why You Should Help Protect Yourself Against HPV.” It featured a man and two women staring provocatively into the camera. Since consumer-directed advertising of pharmaceuticals is illegal in Canada, I wondered what this drug ad was doing on a university bulletin board.

No doubt designed to entice university students of both genders to start worrying about something they’ve probably never even heard of – HPV (Human Papilloma Virus) – it included this bold stat that helpfully stokes fear: “It is estimated that 75% of sexually active Canadians will have at least one HPV infection during their lifetime.” After making the link between HPV, cervical cancer and genital warts, the poster hits the students with the sales hook – I’m paraphrasing here – “Come on down and get your Gardasil 9 vaccinations and your student health plan will save 80% of the cost!” For debt rattled students, the chance of saving $400 must surely be very enticing because, well, genital warts? Oooh, gross.

The grossest thing about this poster was the missing safety information related to the vaccine. But if you looked closely, you could see it had been covered up, as was the manufacturer’s name, Merck, with a sticker showing the potential cost savings. The headline “Gardasil is available at UVIC Health Services for Men and Women” was followed by how the three-dose regime of the Gardasil 9 vaccine would cost students $480 out of pocket but only $96 with their undergraduate Extended Health Plan. What a bargain!

If you held the poster up to the light, you could just make out the safety information. In this case, the vaccine was related to a number of minor things and the classic cover-all statement, “As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.”

What you don’t see on this poster is that Gardasil 9 is a highly controversial vaccine. Yet UVic’s communications spokesperson wondered why I thought the vaccines were controversial. He wrote to me, stating, “While the posters reference a specific drug manufacturer, the overall awareness message is one that benefits students in making an informed decision about immunization.” In a milieu that teaches critical thinking, do we really expect pharma’s propaganda to lead to more informed decision-making?

In my world of researchers, the university’s attitude seems quaint and naive given that many people worldwide consider the HPV vaccines to be poster children for “controversial.” Even though it’s designed to prevent infection by some strains of the sexually transmitted human papillomavirus (HPV), the vaccine has yet been proven to reduce cervical cancer rates. And the potential for harm is real and troubling.

Evidence from the company-sponsored, randomized trials used to approve the vaccine have shown it was generally safe, but ‘real world’ experience has been very different. In the US, for example, up to the end of September 2015, there were 37,474 adverse reaction reports made to the federal Vaccine Adverse Events Reporting System (VAERS) associated with Gardasil. These reports include 209 deaths. What does one make of this? It’s unclear because these deaths are deemed ‘associations’ and one cannot conclude the vaccine alone was directly responsible.

An Alberta study looking at adverse events following HPV vaccination from 2006 to 2014 found that one in 10 Gardasil users were either admitted to a hospital or an emergency room within 42 days of injection. And you can’t ignore groups like SaneVax and others around the globe that were created to deal with HPV vaccine-injured daughters.

Many scientists have been critical of the research and propaganda surrounding the HPV. A group who wrote in the journal Infectious Agents and Cancer said the two basic premises – “that HPV vaccines will prevent cervical cancers and save lives and have no risk of serious side effects” –are likely wrong. They note, “Careful analysis of HPV vaccine pre-and post-licensure data shows, however, that both of these premises are at odds with factual evidence…”

UVic is certainly not the only – or first – university in Canada to allow flagrant marketing of vaccines or drugs of dubious effectiveness and safety. I can think of two recent controversies and the targets again are young women.

Between 2002-2004, if you were in a women’s washroom in a Canadian university or college, you would’ve seen an ad for a drug featuring a glowing, healthy young woman with a shimmering smile and the caption: “Diane-35. Ask your doctor or your dermatologist.” Diane-35 contained two hormones: cyproterone acetate and ethinyl estradiol. The manufacturer, Berlex, advertised it on TV, in bus shelters and on posters at universities. Outraged colleagues of mine wrote letters to Health Canada asking why they were allowing the marketing of such a controversial drug in universities. Controversial, you say?

Everyone – except those who approve posters in the ivory tower – knew about the very dark cloud surrounding Diane-35, which came to Canada in 1998, but was never approved in the US due to safety concerns. After the death of a young woman in Germany from liver cancer linked to the drug, it was restricted in the rest of Europe and in Canada because of suggestions it was toxic to the liver and only recommended as a second-line drug for women with severe acne. Evidence from at least eight studies showed Diane-35 increased the risk of VTE – venous thrombotic events, or blood clots – more than other commonly used birth control pills. Even though Health Canada required the manufacturer to send a letter to all doctors in Canada stating that Diane-35 increased risks of blood clots, the drug was merrily advertised in Canadian universities, including UVic.

Monitoring these events, my colleague Barbara Mintzes at UBC wrote a paper in 2004 entitled, “Drug regulatory failure in Canada: The case of Diane-35.” She wrote, “The Diane-35 advertising campaigns make a mockery of claims that direct-to-consumer advertising educates the public about health treatments. These ads omit the key information young women need to know about this product: that safer alternatives are available.”

Then there’s the more recent case of Yaz or Yasmin, another birth control pill flaunted on campuses, including here at UVic. Like Diane-35, Yasmin increased the risk of venous thromboembolism (blood clots), was more risky than second-generation, older oral contraceptives and no more effective than other birth control pills.

Even though Yaz and Yasmin were touted to treat acne, the drugs weren’t proven to do that. After a short time on the market – but advertised more widely than any other birth control pill – blood clots, heart attacks, strokes and two dozen deaths in Canada were reported. Most of the victims were under 25. A Canadian class action lawsuit followed with more than 1,700 women registering with a Toronto law firm that they had been hurt by Yaz and Yasmin and were seeking compensation.

We know who benefits from widespread marketing of potentially unsafe products to students. But who at our universities and colleges is protecting students from the spin, and scare tactics, of pharma’s dangerous and potentially deadly marketing strategies?

Alan Cassels is a drug policy researcher in Victoria. His most recent book, The Cochrane Collaboration: Medicine’s Best Kept Secret, has just been published. Follow him on twitter @AKECassels

Proton pump inhibitors pose some very serious risks

Think twice about taking heartburn drugs

DRUG BUST by Alan Cassels

PhotoHeadshotAlanCassels

• Warning: this column is for people who are taking (or have been offered) heartburn drugs or are considering treatment for heartburn. In other words: most of us. If you develop heartburn or ulcers, there is a good chance you’ll be offered a prescription from the most effective – and possibly most inappropriately over-consumed – class of drugs on the planet: a proton pump inhibitors or PPIs.

PPIs include drugs like omeprazole (Losec® or Prilosec® in the US), lansoprazole (Prevacid®), rabeprazole (Pariet®), pantoprazole (Pantoloc®) or esomeprazole (Nexium®). They are given for a variety of things including dyspepsia (a catchall term for digestive problems such as stomach discomfort, gas, bloating, belching, appetite loss and nausea), peptic ulcer disease (PUD), gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome. Does stomach acid rising in your throat compel you to make a doctor’s visit? All I’m saying is there is a very good chance you’ll get a PPI faster than you can say “rebound acid hypersecretion.”

The popularity of these drugs is mind-blowingly huge and it’s not uncommon for people to wake up one day and realize they’ve been on the drug for a decade. Maybe you took your first one when you had a small developing ulcer or for an occasional bout of stomach acid that rises in your throat and burns like you’ve downed a red-hot poker. You feel bad because you have this nagging feeling you shouldn’t be taking the drug, but, at the same time, you’re strangely very happy because the little pill works really well in dowsing the flames.

There is one important thing you need to know from the approved product label for PPIs: they are approved for “short-term treatment” of GERD and duodenal and stomach ulcers that are “resistant” to antacids and H2-blockers. The operative phrase is “short term”, so what explains the fact there are upwards of 10 million scripts written every year for PPIs in Canada (about 100 million in the US), the third highest-selling class of drugs in North America?

For starters, PPIs are extremely effective at influencing the production of acid by the stomach. Remember, stomach acid is your friend, helping digest food and preventing infections, but too much of it in the wrong place can be uncomfortable. Up to 30 percent of Canadians will experience some kind of reflux in their lives and peptic ulcers affect roughly 10 percent of us. “Peptic ulcer” is an umbrella term for certain lesions – little pits or “craters” – in the mucous membranes or lining of the stomach and duodenum (top part of the small intestine), which can cause significant pain, bleeding, and, in rare cases, can erode all the way through the wall of the GI tract, leading to a perforated ulcer.

After we chew food, it makes its way down the esophagus and into our stomachs where the process of digestion begins: acid breaks down the food into its essential nutrients. GERD occurs when acid from the stomach ‘backs up’ into the esophagus, irritating it and, in the process, causing heartburn, nausea, burping or belching and an unpleasant taste in the mouth. A sphincter at the junction between the esophagus and the stomach is supposed to prevent your stomach contents from backing up into the esophagus, but it can malfunction for a variety of reasons. Generally, this happens after meals when the stomach is full and when lying down.

For eons, we thought ulcers were caused by stress and that the treatment was antacids, a bland diet or surgery. The ‘stress’ theory of ulcers soon came to be replaced by the ‘bacteria’ theory where a bacterium, Helicobacter pylori (H. pylori) was found to be one of the key causes of ulcers. In the early ‘70s, a revolutionary class of drugs – the H2 antagonists, including drugs like Tagamet or Zantac – were blockbusters in their own right, yet a mere shadow compared to the PPIs, which appeared on the scene in the mid ‘90s. Omeprazole (Losec® in Canada, Prilosec® in the US) was the first in a class of drugs that took the world of acid suppression drugs to a whole new level.

As I’ve said in the past, first comes the marketing, then comes the science, then comes the regret. I would say the PPIs are currently in the ‘regret’ stage. Soon after omeprazole hit the market in 1995, there were reports of adverse effects, including joint and muscle pain, muscle weakness and swelling. And cases of kidney inflammation were reported in some patients after the first few months of starting omeprazole.

In fact, during those early days, some doctors feared PPIs were too effective, because they allowed gluttony to run unchecked. They became a passport to stuffing one’s face without any consequences. In the early days, there were also concerns that prolonged use of PPIs could mask danger signs, such as cancer symptoms. In England, such concerns led to a 1998 warning from the Medical Research Council, which criticized doctors for putting all their indigestion patients on PPIs and failing to ‘step down’ to basic remedies. The Council warned patients would get put on a PPI and never actually have to deal with the lifestyle or other factors conspiring to cause the acid reflux in the first place.

Nearly 20 years later, what can we say? “Boy, were they ever right.” It seems that the strongest drugs to block acid, the high dose PPIs, turned out to be the most dangerous to use especially in the long term and in the elderly. But what sort of dangers do they pose?

The long-term consumption of PPIs has a range of potential dire consequences, which I’ve deemed the Four Risks of the PPI Apocalypse:

Rebound acid hypersecretion risk: wonder why so many people start the drug and can’t stop taking it? Dude, you can become dependent on PPIs in as little as four weeks on the stuff. This is a serious adverse effect that few people seem to be taking seriously. It is based on the fact that once you start feeling better, you stop taking the drug. The acid reflux comes back so strong it knocks you off your feet, therefore you go get another prescription. You have, sadly, become addicted to the stuff.

Fracture risks: taking PPIs for the long term in multiple daily doses increases risks of fractures of the hip, wrist or spine. When you’re tampering with the stomach flora, you’re also tinkering with the composition of your bones. Snap. Crackle. Pop.

Infection risks: the drugs are known to lead to an increased risk of infections, including pneumonia and C. difficile, which is particularly dire for elderly people who have spent time in a hospital. It could lead to them spending many more weeks in the hospital, or worse, dead.

Magnesium deficiency risk: it has taken a while, but information on the risk of severe magnesium deficiency has accumulated and is well known. If you are taking certain meds that alter your heart rhythm, low magnesium can make things a lot worse, including possibly life-threatening heart rhythm disruptions or arrhythmias.

Wait, there’s a fifth: a study out of Stanford University last summer found that “PPI use was associated with a roughly 20 percent increase in the rate of subsequent heart attack risk among all adult PPI users.” Those are pretty powerful words.

What to do when simple heartburn can lead you down a drug-filled path that could lead to a heart attack? Think alternatives.

There are tons of alternatives that can help relieve stomach acid and the best of these are lifestyle adjustments: losing some weight, eating more fibre, quitting smoking and drinking more water or green tea. Less restrictive clothing helps some people and some have found success with ginger, cabbage juice, digestive enzymes and probiotics.

In other words, you can search out alternatives, many of which might not be as powerful as a PPI, but there is something to be said for taking less powerful medicine; it is less likely to kill you or cause collateral damage that could make your life worse.

Alan Cassels is a pharmaceutical policy researcher in Victoria and author of the just-published The Cochrane Collaboration: Medicine’s Best Kept Secret. Follow him on Twitter at @akecassels

Big Data is spying on our doctors

Collected information helps sway doctors to prescribe certain drugs

DRUG BUST by Alan Cassels

Portrait of columnist Alan Cassels

• People often ask me if, given my research on pharmaceuticals, I could tell them why every time they go to the doctor, they always end up with another prescription. It’s impossible to answer that in a sound bite because many factors drive prescribing, including marketing, new research, patient demand, physician workloads and so on. The easy answer: it’s complicated.

Let me boil this issue down to one important ingredient: espionage. That’s right, spying. Both Canada and the US allow electronic spying on our doctors by companies that track, analyze and sell our physicians’ prescribing data.

This, of course, compounds the problems of our drug-addled health care systems, where Canada and the US spend more money per person on pharmaceuticals than every other country in the world and upwards of two thirds of our physician visits end in a prescription drug.

Those in positions of authority say this “intelligence gathering” regarding our doctors is a problem. Some US states have tried to outlaw it, without success. Everywhere in Canada, except BC, Manitoba and Quebec (where doctors can opt out), pharmacies collect complete data on our doctors’ prescriptions and sell them to a data company like IMS Health, which then repackages them to sell to the drug industry. These doctor-specific prescribing profiles are like gold in the hands of pharmaceutical marketers, the medical equivalent of having our doctors’ offices wiretapped, where every script they write tells the companies what kind of doctor you are, what marketing campaigns are (or are not) working on you and ultimately how much you are making for the company. Companies then become very efficient at finding what buttons they need to push to get the doctor to write scripts for their drugs.

It’s a massive problem and the evidence supports me. We know that 60 to 70% of Canadian doctors regularly see drug reps and the evidence around doctor-drug industry interactions show that the more contact doctors have with the drug industry, the worse prescribers they are, across a range of objective measures. Their prescribing is more expensive, they are more likely to prescribe brand name drugs when cheaper generic drugs are available and they tend to prescribe newer drugs faster before their full safety profile can be known. Most of us would accept that our doctors rely on clean, clear information about pharmaceuticals to do their jobs properly and that pharma marketing inevitably taints it. Big Data pushes this into the stratosphere with insights that work to turn our physicians’ thinking about new drugs into toxic sludge.

Consider this scenario: The drug salesman prepares to visit your doctor with a spreadsheet of prescribing data. He finds she tends to favour the antidepressant Cymbalta over others (even though it’s more expensive and probably not more effective than good, old generic Prozac). The drug salesman, representing the maker of a newer antidepressant, Pristiq, knows a lot about this doctor. He knows exactly how much Prozac, Cymbalta, Zoloft, Effexor or Pristiq she writes. He knows he has to use those data to put the best spin on Pristiq while knocking Cymbalta down a few steps. “Oh doctor, did you see this new warning about the suicidal side effects of Cymbalta?” or “Pristiq is so exciting all the psychiatrists in town are using it.” The drug rep might also have details covering the doctor’s personal information and, of course, a record of every single prescription she has ever written.

An article from Bloomberg last month talked about a new US company, Zephyr Health: “Zephyr builds digital dossiers on individual doctors. It starts with basic information on prescription patterns from data clearinghouses such as IMS Health and Symphony Health Solutions. Then its software, with some human assistance, scours the Web for more details.” The article describes how Zephyr parses the speaker’s lists of medical conferences and finds who is “well-regarded” by peers. It looks for those who sit on guideline writing committees or who might be ripe to become one of the company’s KOLs (Key Opinion Leaders). Zephyr’s approach ranks doctors on their perceived “influence and ability to drive sales” so when a new drug arrives that “needs the right kind of marketing and promotion,” Zephyr is there to help the companies quickly target the right people.

In Canada, the data company IMS Health Canada sells a product called “Xponent,” which deploys a “perfected geospatial methodology” to help “companies gain unequalled insights into prescription demographics and prescribing choices.” How it works would be purely farcical if it wasn’t so Orwellian: “IMS Xponent ranks and aggregates Rx volumes for each doctor, market and product combination [and] helps companies develop brand strategies based on unique customer attributes, identify and act on changes in behaviour and measure market share trends within key customer segments.” Given our somewhat sacred relationship between patients and doctors, you would think we’d have built up solid safeguards around the sale of the doctors’ prescribing information.

Murray Long, a retired privacy consultant in Perth, Ontario, attended a parliamentary committee hearing in 2006 when groups such as the Canadian Medical Association (lobbying to curtail such practices) and IMS (lobbying to maintain them) were examining Canada’s data privacy laws. Against the private interests lobbying to maintain “their right to unfettered access to this data,” the CMA maintained that national law should, at least, be brought in line with Quebec’s act, which allows doctors to “opt out” if they didn’t want their prescribing information to be sold to commercial entities. That failed. And many other factors have conspired to keep it that way. Murray Long thinks the issue in Canada is “as dead as a dodo, at least at the federal level” and even though it’s clearly not in the public interest in his mind to allow drug companies to buy that information, “we’re continuing to keep our heads in the sand.”

The way this war will be won is at the provincial level. According to Murray Long, to start to counter this, a complaint would have to be made to the federal Privacy Commissioner, but you would have to “swim very hard upstream” to convince the Commissioner to reverse previous decisions that say prescribing data is not a doctor’s personal information. He told me, “The best venues to see some controls on IMS access to this data are likely within the provinces.”

In BC, we can thank the NDP government in the early 1990’s for specifically disallowing “information related to a practitioner” to be used “for the purpose of market research.” This may have kept the gate closed for the meantime, but there are still many who would like to see BC’s “doctor-level” prescribing information collected and sold to the drug companies. On March 11, the Data Effect Conference in Vancouver will discuss, among other things, ways to leverage BC’s rich store of healthcare data into “multi-billion dollar public and private investments in health care.” Will the conference attendees be figuring out how to appease Big Data by engineering what they want: direct access to our physicians’ prescribing records?

Meanwhile, groups like IMS Health Canada and Zephyr Health are tracking and spying on our doctors and constructing even more insidious ways to market their wares. Again, why are we such incredibly heavy users of pharmaceuticals in Canada and the US? It’s complicated, but could it be at least partly due to the fact we’ve allowed the spies to insert themselves into the practice of medicine?

Where are the rebel doctors when we need them? Who will stand up to this lunacy and stop what is obviously a harmful, deceitful and deadly method of gathering intelligence on our doctors and using it against us? Will the Canadian Medical Association ever go to war against the spies? I’m putting this out there. Maybe we need a campaign and I’ve got a handy slogan: “Stop Spying on our Doctors.”

Alan Cassels is a pharmaceutical policy researcher in Victoria and author of the just-published The Cochrane Collaboration: Medicine’s Best Kept Secret. Follow him on Twitter at @akecassels

Prescribed opioid drug abuse in Canada

DRUG BUST by Alan Cassels

Portrait of columnist Alan Cassels

• Calvin, the central character of my column this month, is a nice, hard-working guy who could be anyone’s relative. But he’s not a real person; he’s a composite I created out of several people whose stories I have followed over the years. In this scenario, he’s a 32-year-old carpenter who had a minor accident a few years ago where he fell and hurt his back. He was prescribed tramadol and later oxycodone – a widely prescribed opioid narcotic – to help control the pain. Over the next few weeks, he got a bit of physiotherapy to strengthen his back and his pain slowly lessened, but not his use of the drug. After three weeks, he tried to stop taking the oxycodone, but he experienced such incredible aching, sweating and chills that he went right back on it. Calvin may not have needed the drug anymore, but he couldn’t stop because of the withdrawal symptoms every time he tried to quit.

Here’s where the story gets interesting. When his supply started running low, he went back to his doctor and after two refills, the doc told him he couldn’t prescribe them anymore. Desperate, Calvin found that, on the street, a single pill of “Hillbilly Heroin” – the street name for OxyContin – costs $10. So that’s where he got his supply from until one day, one of the dealers suggested he try heroin, advising him it was cheaper and easier to find. Within three months of his accident, Calvin was now an unemployed heroin addict, barely holding it together and wondering where he was going to get his next fix.

Today, when people use the term “abuse” in relation to prescription drugs, they are almost always referring to opioids – powerful, pain-relieving drugs like morphine, hydromorphone, oxycodone, tramadol, fentanyl and others. The abuser is often characterized as a crazed druggie whose unravelled life is due to his own character flaws. Yet when one considers that many people like Calvin became that way through serious flaws in the system, we have to ask, “Are we doing enough to avoid these preventable tragedies that destroy peoples’ lives?”

From 2010 to 2014, opioid prescribing in Canada jumped 25 percent to more than 22 million scripts going out the door every year, according to the pharmaceutical data firm IMS. Data from the Pain and Policy Studies Group at the University of Wisconsin-Madison show that Canada has the second highest opioid consumption in the world after the US. We swallow almost 10 times as many opioids per capita as people in the UK, five times as many as France and four times as many as New Zealand. According to data from Ontario’s coroner office, prescription opioid-related deaths in Ontario doubled between 1991 and 2004 and more than tripled between 2004 and 2012. In 2012, there were 536 opioid-related deaths in Ontario alone; extrapolated across the country, that would give us about 1,400 opioid-related deaths in Canada per year. The US, by contrast, has about 19,000 opioid related deaths per year. Other countries have people in pain who need pain relief; why are they not seeing the gross numbers of overdoses and deaths related to opioids as we are in North America?

Some people maintain the solution is to crack down on opioid prescribing because most of the “abusers” are getting the drug from a prescription pad. But it is highly problematic to make access to these drugs too strict; you would end up denying too many legitimate patients who need help for their severe pain. At the same time, making the drugs too easy to get means people can more easily become addicts, with more of the drug ending up on the street, adding to society’s overall toll of addiction, overdoses and deaths.

Clearly, one of the best ways to reduce the deaths from opioid abuse and overdose is to encourage doctors to consider other, possibly safer medications to start with. Most would agree that better education – both for physicians and patients – on the full range of possible pain treatments may steer more people towards drugs that are less addictive and less dangerous. Alternative ways to treat pain, such as physiotherapy, chiropractics and even cognitive behavioural therapy, can be very helpful for many people, but they are more difficult to access and not as widely covered. Pain clinics that specialize in treating patients with a range of measures are helpful, but waiting for a pain clinic might take months or years.

Things have radically changed in the last two decades around the use of these drugs. It used to be that opioids were only prescribed for people with the severe, acute pain that comes with surgery or cancer. There are very effective treatments for non-cancer pain that aren’t addictive like the opiates, but when OxyContin began to be widely promoted in the mid 1990s, physicians were told the drugs were less addictive and safer than they actually were.

Prior to about 1996, the year OxyContin was approved in Canada, overall opioid prescribing was a fraction of what it is today. Purdue Pharma, the drug company marketing OxyContin, crafted a narrative stating its new drug was a safe, long-acting drug designed to treat chronic pain. To enhance that message, the manufacturer funded promotional materials for medical students, including textbooks on prescribing for pain. By downplaying the addiction potential of opiates like OxyContin, not only were patients getting addicted, but doctors were exposed to biased and dangerous information. Patients suffered and died because of that faulty advice.

So back to Calvin. We might ask if he could have been better served with a non-opiate drug for his pain. Did anyone ever tell him he might become dependent on the drug? If someone recognized that things were going off the rails for him, wasn’t there a safer option than turning to heroin?

Two Toronto-based drug policy experts, Dr. Joel Lexchin and Jillian Clare Kohler, have studied the promotion of OxyContin in Canada and the US, which they think is behind the widespread use and abuse of that product. Writing in the International Journal of Risk & Safety in Medicine, they say that any drug with a “high potential for abuse” should be strictly overseen by regulatory authorities for the first two years it’s on the market. They also say “prescription event monitoring programs” should be set up for these drugs so that any adverse events experienced by the patients for at least six months after the drug is marketed can be collected and reported.

Dr. David Juurlink, a Toronto physician who is a stern advocate for rationality in the opioid wars, has followed the opiate issue intensely. He thinks things might be levelling off and slightly improving, but there is still a long way to go. He told me in an email that even when doctors agree about the dangers of opioids, many of them “have unreasonable views on the safety and effectiveness of these drugs and often look for excuses to blame what are clear drug-related problems on other things.”

At the end of the day, people like Calvin, when trying to stop or reduce their dose of an opioid, will develop early features of opioid withdrawal and that means they will continue to take the drug just to function.

I have a lot of sympathy for doctors on this issue and perhaps even more for patients like Calvin, whose life has fallen into a pain dumpster and he can’t get out. Since our doctors clearly want to help, but don’t have time to become detox experts, my non-expert opinion is that the Calvins of the world need better options and a better system to care for them. As an individual patient, what should you do? There are no easy answers except to say if you are in severe pain, you will want to go slow and go low on these drugs. You’ll need to work with your doctor to help minimize the harm and maximize the benefit for every single prescription you get.

This is not easy. We have a national tragedy on our hands, but we also have the means to fix it.

Alan Cassels is a drug policy researcher in Victoria. His most recent book, The Cochrane Collaboration: Medicine’s Best Kept Secret, has just been published. Follow him on twitter @AKECassels