Saying no to chemo – the medical and media backlash

DRUG BUST
by Alan Cassels

“I don’t know how to lay an egg, but I know when it’s rotten.” That’s the translation of the title of the just-published book by Quebecois journalist Josee Blanchette whose clarion voice is creating waves in the cancer world. (Je ne sais pas pondre l’oeuf, mais je sais quand il est pourri.)

Facing a cancer diagnosis herself, Ms. Blanchette decided to look closer at the treatment offerings and she was astounded at what she saw. By drilling into clinical trials, she found that many of the modern cancer drugs on offer do almost nothing to alter the length and quality of a person’s life. She also found that most oncology experts seem unable to divert from the guidelines they are told to follow and that the indifference to patients’ deep wishes to know the truth about their disease means that a lot of heroic, but degrading, care is dealt to people at the end of their lives. And, of course, the massively powerful pharmaceutical industry is there giving a decidedly dark tone to the enterprise of modern cancer care.

As a media personality herself, Ms. Blanchette is articulate and forceful. She appeared on a number of high profile Canadian media outlets talking about her findings, including CBC radio’s Sunday Edition. In a documentary called Saying No to Chemo, she discussed, among other things, her decision not to undergo chemotherapy. She cited an Australian study published in 2004, which looked at five-year survival rates for those who underwent chemo for 22 different types of cancer. With success rates averaging between 2.1 to 2.3 percent (treating adults) in addition to the well-known fact that the effects of chemotherapy range from the merely uncomfortable to the fatal, she found comfort in refusing further chemo. But what a sin that was.

Talking to the media was like throwing a hand grenade into the cancer world. Oncologists went ballistic, jumping all over her, saying she was going to scare people off their treatment. Vilified in the press and accused of being a hack for holistic treatment that promotes organic vegetables and turmeric, Ms.Blanchette discovered something very vital: that when journalists look too closely at medical care and point out all its failings, the truth of what they find can be measured in the size of the backlash. And this backlash was fierce.

What Josee Blanchette found is supported by other research. Last month, in a series of articles, the BMJ (British Medical Journal) looked closely at those cancer drugs approved in the US and Europe between 2008 and 2013. It found that most were approved on the basis of surrogate outcomes (ie: things like tumour shrinkage or a blood marker that often doesn’t correlate to survival or quality of life). One major UK newspaper summed it up with this headline: “The costly cancer drugs that don’t help patients.” One oncologist responding to the BMJ articles said the system of cancer care in the UK “encourages doling out of chemotherapy without thought.”

Despite these studies questioning the basis of much of what passes for cancer care in the modern world, is there a rich and energetic level of debate among those who are charged with dealing with cancer? Sadly, there seems to be little debate, or if there is, very little reaches the public airwaves. I wonder if debates within the cancer world could be shared? (Maybe any oncologists out there could contact me and tell me what they are, hint, hint.)

As the #2 killer (beside heart disease), Canadians should all be concerned about the quality of cancer care in this country and the grossly inflated costs for the newer, high-tech cancer drugs, which many would admit are toxic, minimally helpful and often make peoples’ final months sheer misery.

The media cannot escape blame here. Many media outlets don’t have the courage to do what CBC did in airing the documentary; they are too scared to upset the cancer orthodoxy. Much of the reporting covering cancer therapies is lame and propagandistic, describing “miracles” and “cures” and hyping treatments far beyond what is reasonable.

You’ve seen the stories, often featuring a sympathetic patient who has a desire to ‘do anything’ in waging their personal war on cancer. By the way, the military analogy about fighting “wars” on cancer is repugnant and doesn’t advance our understanding of the complexity of cancer. But it’s great grist for fundraising in cancer charities or building markets for new drugs. Often, the patients featured in these stories are lucky enough to show some response to a drug, but they are almost never the patient who faces the drug’s adverse effects – the one who ends up in the ICU with kidney failure or whose life ends earlier because of a drug’s fatal toxicity.

Most people given a cancer diagnosis find that their world suddenly becomes numb. Everything else in your life goes straight into the backseat. You’re not in the driver’s seat any more and, from now on, cancer care is basically ‘what you do.’ Your life becomes a series of appointments, scans, biopsies and tests with drugs, more drugs and even more drugs to deal with the side effects of the side effects of the drugs you’re told are essential. Then there is the waiting, the uncertainty and the many unanswered questions, which get repeated and bounced around inside a team of professionals until you feel you’re losing your mind because no one seems to be talking to anyone else. It’s like hell, but probably worse.

I’ve had two very close people in my life die from cancer and I can tell you there is no lower time in your life than when you are a witness to someone facing terminal cancer. In the cases of my family members, there was a declared, and strongly supported, desire for “no heroics.” There were no last-ditch efforts at doing this or that, no heavy-duty toxic drugs to deal with and minimal travelling back and forth to clinics and hospitals for doctor visits and X-rays and all those things that define a cancer patient at the end of their days. Their care to the end was excellent, compassionate and attentive, but it was minimally invasive.

What I saw in the death of my loved ones by cancer was a dignity that I think is often stripped from people. This dignity is born of acceptance and tolerance, with the knowledge that though you’re going to die, your job comes down to one thing: enjoying the days you have left with the people you love. Many patients who face the painful side effects of cancer therapies will do so because they feel “that’s the price to pay.” They may be told the therapies on offer are their “last chance.” Many will struggle with the toxicity of those therapies, but feel they have to tolerate it, at great cost to their dignity and the quality of their few remaining days.

In healthcare, people often discuss “patient preferences” and the importance of the patient’s desires when it comes to determining their course of care. Sometimes, “what the patient wants” is at the centre of the orbit and good physicians will always circle back to it, saying, “This is what you said you wanted; do you still want it?” Other times, it will be paid brief lip service, as in, “Yeah, yeah, we know what you want, but you gotta keep taking that drug because your hemoglobin is blah, blah, blah…” Numb.

What to do?

A recent essay in the BMJ on this subject of cancer care may have nailed the one key thing that needs to happen. An *article by BMJ editor Tessa Richards, who was treated for cancer, stresses how important it is for the public to know about the problems, and even scandals, in cancer care. Pretending things are just ducky is no way forward. She suggests that, if we really want to serve patients, we need them involved in research and medical conferences. We need their voices and we need them telling their stories.

Josee Blanchette may be vilified by the cancer industry for speaking the truth, but it is a truth that needs to be heard more often and by more people, hopefully before any of us have to face the cold, hard face of a cancer diagnosis.

* The responses to the “cancer drugs scandal” must fully involve patients www.bmj.com/content/359/bmj.j4956

Alan Cassels is a pharmaceutical policy researcher in Victoria who has lost his father and a sister to cancer.

Mass murderers and SSRIs

Connecting the dots

DRUG BUST
by Alan Cassels

I write this as the US is wallowing in another round of hand-wringing from another mass shooting. The carnage in Las Vegas featured a guy with a dozen or so probably legally obtained rifles raining bullets on the crowd attending an outdoor concert. His actions resulted in nearly 60 dead and 500 or so wounded. News reports say the police continue to probe the shooter’s motives. After all, don’t we all want to know the ‘why’ of what seems like a senseless act of violence? Maybe if we understood what happened, we could prevent such events in the future, right?

Yet as his motives are hypothesized, dissected and discussed, most of us just wonder if the guy was ‘crazy’ and what made him so. The killer’s background, his childhood, his links to terrorists organizations and his state of mental health will be extensively probed. But here’s one dominant theory that won’t get much airtime, but which has been circulating for at least two decades: maybe it’s the drugs.

Even before the 1999 horror of the Columbine High School shootings, theories about the effects of psychiatric drugs had been proffered. We know that one of the Columbine shooters, a boy named Eric Harris, was taking the SSRI Luvox. Psychiatrist Peter Breggin, author of Toxic Psychiatry and Talking Back to Prozac has written extensively about violence in association with taking SSRI antidepressants. He wrote that Eric Harris was probably suffering a “drug-induced manic reaction caused by Luvox,” adding, “The phenomenon of drug-induced manic reactions caused by antidepressants is so widely recognized that it is discussed several times in the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association.”

It could be that taking any number of psychiatric drugs may be like putting a match to a powder keg of an angst-ridden and suicidal person, who is heavily armed. We have long known that the most commonly-prescribed antidepressants – selective serotonin reuptake inhibitors (SSRIs) – sold as Prozac, Paxil, Effexor, Celexa, Luvox and Zoloft, can trigger impulses that lead to suicide or homicide. While these drugs are prescribed for depression and mood disorders, they have carried FDA black-box warnings since 2004 and are associated with “a risk of suicidal thinking, feeling and behaviour in young people.” Whether or not this association happens in adults has been roundly debated for years, yet there are other adverse effects related to SSRIs that can be equally deadly.

Akathisia – a reason for suicide?

All of the SSRIs can cause akathisia in some patients. Akathisia has been described as “subjective distress,” a state of unbearable discomfort where the person suffers extreme restlessness and agitation. It is an emotionally turbulent state that some say can lead to a sort of ‘out-of-body’ feeling. One expert witness in a lawsuit involving Zoloft described it this way: “It may be less of a question of patients experiencing [SSRI]-induced suicidal ideation than patients feeling that death is a welcome result when the acutely discomforting symptoms of akathisia are experienced on top of already distressing disorders.” He went on to say that “akathisia has the potential, when it is severe, of contributing to suicidality and aggression.”

The numbers of people taking SSRIs in our society are huge, yet the rates of those who commit violent acts of rage are, thankfully, small. Or are they? It’s likely those data aren’t collected, but there seems to be growing evidence these drugs sometimes play a role in the commission of violent acts. The website SSRI Stories (www.ssristories.org) describes itself as containing “over 6,000 stories that have appeared in the media – newspapers, TV, scientific journals – in which prescription drugs were mentioned and in which the drugs may be linked to a variety of adverse outcomes including violence.”

Some might debate these ‘data,’ saying it is always ‘crazy’ or deranged people who commit these violent crimes. In fact, the lawyers defending the drug companies in hundreds of class action lawsuits almost always point out that, if people commit suicide or other acts of violence while on their drugs, it is because those people are severely depressed and that it’s not the fault of the drug. At the same time, it is well known that stopping, starting or altering doses of SSRI medications can cause terrible, adverse effects in some people.

One such incredibly heartbreaking story concerns a man in Ontario who suffered one of the rare, but more serious, adverse effects related to SSRIs: severe psychosis and delusions. In 2004, David Carmichael, suffering from psychosis, killed his 11-year-old son, Ian. He was taking the antidepressant Paxil at the time and was immediately charged with first degree murder. Later judged to be “not criminally responsible” for murdering Ian on account of a mental disorder and freed from jail, David Carmichael has a different take on what was actually going on. He carefully documents his story on the website www.davidcarmichael.com and has become a bit of a local champion in terms of publicizing the many scandals around the SSRI antidepressants.

Carmichael writes that, according to Andy Vickery, a trial lawyer from Houston, “Big chemical drug pharmaceutical companies argue in wrongful death claims involving SSRIs that suicides and/or homicides are triggered by the ‘disease’ (e.g., major depression), not the ‘drug.”

He adds, “The evidence that my lawyer collected immediately after I killed Ian contradicts this argument. My ‘psychosis’ was not triggered by my ‘major depression.’ Results from the psychometric tests indicate that I was not in a major depression at the time of the killing. It appears that Paxil shot me out of my depression into a severe psychotic state within three weeks of starting the drug and within two weeks of increasing my dosage from 40 to 60mg a day.”

This observation is backed up by a psychiatric assessment. In his PDF-available book entitled Killer Side Effects, Carmichael writes that a forensic psychiatrist at the Brockville Mental Health Centre told him that, while he was in a severe state of depression, it was Paxil that “likely triggered the psychotic episode that caused me to kill my 11-year-old son Ian on July 31, 2004, not my major depression.”

Prescripticide

David Carmichael is articulate in describing what he thinks killed his son and has coined a word to describe it: “prescripticide.” He writes, “Adverse reactions to SSRIs are causing people to commit suicide and homicide and, in fact, adverse reactions to prescription drugs are the 4th leading cause of death in Canada after cancer, heart disease and stroke.” He came up with a single word to explain what is happening: “prescripticide.” (See https://rxisk.org/three-weeks-to-prescripticide/)

Is “prescripticide” really a ‘thing’? Are widely used prescription drugs facilitating behaviour that may sometimes lead to murder? Maybe it’s best to look at what the manufacturers themselves are required to say: as of 2004, all labels for SSRI antidepressants are required to list the following adverse effects: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity and akathisia.

It might be too early to tell what drug the killer in Las Vegas was taking, if anything, but you can be sure there will be other mass killings and likely other mass murderers who were acting under the influence of an SSRI. People worry about the uncontrolled gun culture in the US, but perhaps most worrisome is that we’ve also got an uncontrolled population of millions of people taking psychiatric drugs as well and the two are a potentially toxic combination.

When David Carmichael says, “If I’m not criminally responsible for murdering Ian, maybe someone else is,” I think there is a whole range of possible suspects, many who, unfortunately, will still be getting away with murder.

Alan Cassels is a writer and former drug policy researcher. His latest book is The Cochrane Collaboration: Medicine’s Best Kept Secret. @AKECassels

The Daisy Project

One woman’s inspiring journey through BC’s mental health system maze

DRUG BUST
by Alan Cassels

When you spend as much time as I do reading medical literature, parsing studies and thinking about their statistically significant ‘findings,’ you get a certain view of medicine. Research is not created equal and there is a strict hierarchy of evidence where randomized trials are considered superior forms of evidence in evaluating treatments. Better yet are those meta-analyses; the combined summaries and syntheses of many randomized controlled trials (RCTs) are considered the gold standard in determining if there is ‘proof’ of a treatment’s benefits. At the other end of the spectrum are ‘case studies’ that may be just the observations of one or several patients. Then there are personal stories which tend to be ignored, dismissed as ‘anecdotal’ and said to be of limited usefulness.

While I am all for good-quality meta-analyses, I also think we have a lot to learn by reading case studies and personal stories. They are really important and can be very illuminating, often revealing, in excruciating detail, how our health system works in the real world to help sort out peoples’ health problems.

Over the last 20 years or so, I have been contacted by hundreds of people, all with a story to tell, often with an altruistic motive which says, “I don’t want others to suffer the way I have.” Among those who have called me, those taking statins often ask if their muscle weakness could be due to those cholesterol-lowering drugs. “Likely,” I say. Others wonder if their mother’s anti-alzheimer’s pill could be causing her to feel nauseous. “Probably, yes.” Others question the prescription for an amphetamine for their 10-year-old boy who can’t sit still (sheesh). These people all have stories to tell and they are rich and rewarding.

What many of these people have in common is that they have been harmed by the treatment they’ve been prescribed. But what isn’t common are those who have gone through terrible medical experiences yet can move beyond the trauma to meaningfully communicate it to others.

Over the last 30 years or so, Daisy Anderson has seen 18 different psychiatrists, been prescribed more than 30 different medications, was given electric shock treatments, been hospitalized repeatedly and faced the stings of rejection and isolation. With an admittedly difficult childhood, marred by various types of abuse, she documents her slow journey through BC’s mental health system in incredible detail. Her story, just published in the book, The Daisy Project: Escaping Psychiatry and Rediscovering Love, speaks to those who find themselves navigating what passes for mental health care in BC.

I asked her why she wrote such a book, painfully recalling and documenting her struggles in what seemed like an incredibly uncaring, hostile system. Her answer was simple: she wanted to tell the world when she got better. She didn’t like the way she was being treated and she wanted her life back.

The problem, of course, is being diagnosed with a mental illness and trying to get well when it seems everything – including your family, the medical system and even the lawyers – might be working against you. It means negotiating for yourself and being your own advocate. As Daisy writes, “Disability was about letters, forms and proving that I was extremely ill. It also meant having to ask a hotheaded psychiatrist to write a letter and sign his name.”

Thankfully, she did find people along the way, particularly a psychologist, and others who were able to help her. As she writes, “I sought solace from anyone who would listen.” A switch happened when she admitted to her very helpful psychologist that “psychiatry may have harmed me.” For her, “it felt like a turning point, a sign of my transformation from an indoctrinated psychiatric patient into a strong independent woman.”

Many of the people who end up in the mental health system are there not because they have a ‘brain disease,’ but because they may have ended up with a diagnosis of ‘anxiety’ or ‘depression,’ which started them down a cascade of anti-anxiety drugs or antidepressants. Daisy’s life might be a testament to what happens to adults who have been through childhood abuse, yet it was the abuse by the mental health system that really slowed her recovery. But Daisy survived the dismissive psychiatrists and their armamentarium of toxic drugs and thrived in spite of them, refusing to accept the view that others had of her. Thankfully, she found a psychologist who “really listened,” helping immensely. Unfortunately, psychological help can be very expensive and not readily available for people on limited means. As to the ‘secret’ of her survival, she told me, “I just had to tell my story.” Being a natural documentarian where her diary was her “release,” her pages and pages of records and copious notes all helped her advocate for herself based on the facts of her own case.

As for getting off drugs, she comments on the system I know about, in which people take prescriptions with very limited ‘informed’ consent. As for all the drugs, she told me, “You need to know a lot and you need to be given time to think about it. You need to be given alternatives and you need to know the problems you will face on the drugs.” For example, you can develop diabetes with the newer antipsychotics, but nobody is typically informed of this or really understands what the full ramifications are of getting a ‘new’ disease. The drugs, she says, are “complicating things immeasurably because the doctors don’t see the side effects or underestimate their effects on one’s day to day living.”

Most people might not know that stopping many psychiatric drugs involves a “withdrawal effect,” which can make them terribly ill. Unfortunately, tapering patients is not a speciality of most doctors and, for Daisy, stopping her benzodiazepines (drugs prescribed for anxiety or sleeping) was difficult. Along the way, she had to research the best ways to do so (discovering the Ashton Protocol) and take information to her doctors so they could reduce her drugs slowly and safely.

Above all, Daisy’s “project” is a plea for people to be “listened to.” She shows that to improve the care of people with mental health difficulties, the system needs to be adaptive. “Not everyone will benefit from counselling, medication or cognitive behavioural therapy,” she says, but people should be offered these options. “There has to be far fewer medications” and most importantly, she says, people with mental health problems need “someone who can listen and understand.” What also helped her return to health was many of those other things that generally increase our enjoyment in life: yoga, walking, being in nature, belonging to art and craft groups and spiritual practice. “Basically, being in a community of people who accept you as you are.”

I asked Daisy what is causing the growing sense of mental ill health in society and she responded immediately, “Lots of people go through tough times. But when you lose your husband, etc, you may need support, but you don’t need medication.” She adds, “Sometimes, we get blamed for being sick when, in fact, society is doing it to us.” For her, the solutions are complex, but she emphasizes going to the root: “The first thing we need to do is care for our children… but don’t blame parents.”

The new NDP government created a new Ministry of Mental Health and Addictions to deal with the issues. According to the Ministry, “One in five British Columbians will be affected by a mental health and/or substance use problem this year.” Minister Judy Darcy received a ‘mandate’ letter from the new premier which stated that her job, in part, was to ”guide the transformation of BC’s mental-health-care system” and to “focus on improving access, investing in early prevention and youth mental health.”

I’m hoping Judy Darcy will have people like Daisy Anderson advising her.

EVENT

September 14, 7PM: Vancouver book launch of The Daisy Project: Escaping Psychiatry and Rediscovering Love. At the Unitarian Church of Vancouver, 949 West 49th Ave. All are welcome. Free.

Alan Cassels writes about pharmaceutical policy in Victoria and is the author of Seeking Sickness: Medical Screening and the Misguided Hunt for Disease. www.alancassels.com

More cholesterol craziness

DRUG BUST
by Alan Cassels

Ask if Repatha can get you on the path to way lower LDL. – Advertisement for the new LDL-lowering drug Repatha.

Some days I love this crazy drug world where there is a never-ending trove of stories that continue to amaze and entertain. This summer, it’s worth introducing my readers to a very new and ultra expensive class of cholesterol-lowering drugs known as proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitors. They do an amazing job of lowering LDL, known as the “bad” cholesterol.

Certainly, on that parameter alone, they are much better than the oft maligned statins, but the main question is whether governments, and individuals, will be able to afford PCSK9 inhibitors. At $8,000 or so per year, this injectible drug will cost about 50 times more than statins.

While I’ve often maligned statins myself, it’s more due to the very real questions around the alleged dangers of ‘high’ cholesterol and what kind of meagre impact we see when medicating a normal and vital substance in our blood. To summarize in one sentence the arguments I’ve made over the last decade, lowering cholesterol with statins makes astonishingly small differences to the length and quality of most people’s lives.

Even for those who are at ‘very high’ risk of a heart attack or stroke, taking daily statins for five years might, at best, reduce their risks by two to three percent. Which is to say, 97 to 98% of people swallowing a daily statin are unlikely to see any benefit from them. Besides wasting their money and unnecessarily exposing themselves to statin dangers such as muscle weakening, cognitive effects and other bad effects, people can do many more things to improve their cardiovascular health.

So along come the PCSK-9s with another aggressive war on high LDL and some pundits predicting “blockbuster” status for these drugs. Some predictions say this class of drugs could cost as much as $100 billion per year in the US, making the PCSK9 inhibitors the costliest drug therapy class in the history of humankind. As we surpass new heights on the pinnacle of pharmaceutical absurdity, I am still jaw-droppingly awed by the length to which we humans will go to medicalize and medicate our cholesterol levels. And because of the mind-boggling amounts of money at stake, you can imagine there will be lots of high-priced rhetoric in the medical press working to get you to take these drugs.

The first two approved PCSK9 inhibitors in Canada are alirocumab (Praluent™) and evolocumab (Repatha™). They are approved for “the treatment of primary hyperlipidemia and mixed dyslipidemia (high levels of “bad” cholesterol).” Basically, looking at the ads, they seem to be pitched to anyone who requires “additional lowering of LDL-cholesterol.” In other words, “all of us.”

Let me summarize six reasons why you should probably not get too excited by this new class of drugs and why we need to be skeptical of many new drug claims.

1. Big trials: If you have to enroll a ton of people into your trial, that’s a sign the drug has a very small effect. The Praluent (ODYSSEY) trial enrolled 18,000 patients and the Repatha (FOURIER) trial enrolled 27,000 to see if the drugs reduced cardiovascular risk. Another trial (SPIRE-1 and 2) testing Pfizer’s PCSK9 inhibitor, bococizumab, enrolled 32,000 patients and was stopped early because even with that many people, the drug turned out to be a dud.

2. Exaggeration of the treatment effects: Many media reports on the PCSK9 inhibitors tended to exaggerate the effectiveness of the drugs, saying they reduced the risk of heart attack and other major cardiovascular problems by “more than half,” compared with standard treatment alone. One study in the New England Journal of Medicine showed patients taking evolocumab had about a 1% risk of cardiovascular events compared with 2.2% in the control group, for a 1.2% absolute risk reduction. But since one is “50% less” than two, you can imagine how the spin doctors repeat ad nauseam the impressive sounding “50% reduction.” Basically, it’s better to say the drug reduces risk by “50%” than to say the drug may have helped one in 100 people, which, um, is not so impressive.

3. Too many safety unknowns: Like any new drug, there are things we don’t yet know. The concerns here are around the neurocognitive effects of the drugs and whether they may also cause cataracts and type 2 diabetes. In the pre-approval studies, there were more strokes among the patients taking the PCSK9 inhibitors, compared to placebo. There is good reason that in the US insurance companies and pharmacy benefit companies are restricting the use of these drugs. Not only are they costly, but they could possibly be less safe than the alternatives. They typically require a patient to have tried at least two statins and ezetimibe – a statin ‘booster’ – before considering a PCSK9 inhibitor.

4. There are alternatives: For many, statins “work.” Some commentators have argued that PCSK9s will never be mass market drugs like statins. Statins are now generically available, tolerable to many people and easily available. Plus, you don’t have to get an injection with a statin. Unless there is some serious science discrediting the statins, they may remain the king of the cholesterol-lowering world for a long time yet.

5. Market forces and prescribing habits seem to be working against these new drugs: Since they were introduced in the US and the UK, uptake has been very slow, not even reaching a quarter of analysts’ projections. Added to this are skeptical clinicians who are not all (yet) convinced of the overall benefits and safety of these more difficult to administer treatments. You can imagine the PR world is working on that particular problem. Doctors have been fooled in the past due to the frequent exaggeration around the benefits of statins and the downplaying of the risks, so maybe they’re more cynical this time around.

6. Sticker shock: Governments, insurers and others have been dragging their heels due to the sticker shock. In Canada, the annual price tag for the PCSK9s will probably range from $8,000 to $11,000 compared to the annual statin bill which is somewhere between $90 and $1,400 in BC. In the UK, the National Institute for Health and Care Excellence (NICE), which appraises new medicines and health technologies initially rejected both PCSK9s. They have now approved evolocumab. In the US, the New England Comparative Effectiveness Public Advisory Council said the PCSK9s were “effective but overpriced.”

One wonders what is happening in BC and whether or not these drugs will be approved for coverage and prescribed by our doctors?

Those are both good questions and seeing as we’ve got a new government coming in, we have lots of opportunity to improve drug coverage decisions. The BC Ministry of Health recently sent out a notice requesting “Public Input into PharmaCare Drug Coverage reviews,” adding that “the Ministry of Health is considering evolocumab (brand name, Repatha) for coverage.

BC’s Drug Review Process, however, is not perfect. Right now, our Drug Benefit Council (DBC) gives advice to the Ministry. The DBC looks at research around the drugs, consulting the national Common Drug Review (CDR) as well as considering if the drug represents “good value for the people of BC.” They tend to collect input from doctors, patients, caregivers, patient groups and the manufacturers and use this information to make coverage decisions.

There are a million ways for the pharmaceutical manufacturers to insert themselves into the process. They will want the government to spend our money on these new drugs. Other more sober voices, including mine, would say we need to study them more and decide if they represent good value.

BC has a chance to be wise, to resist the lobbying and PR efforts designed to spend money on drugs like this. Our new government is going to be surrounded by lobbyists representing companies that make such drugs. We hope they will be wise and not fall prey to all the PR tricks used to spend our money on questionable forms of healthcare.

Alan Cassels is a writer and former drug policy researcher. His latest book is The Cochrane Collaboration: Medicine’s Best Kept Secret. @AKECassels

We’ve got good people and evidence

All we need now are good institutions

DRUG BUST
by Alan Cassels

Consider just a few classes of drugs that are pretty universally, but irrationally, used. For example statins, drugs that lower cholesterol, likely produce very little benefit for the vast numbers of the population who swallow them, and some are harmed in the process. Antihypertensives, drugs that lower blood pressure, are prescribed to seniors to such an extent that they are more likely to increase the risk of hip fractures than prevent a heart attack. And attention deficit disorder drugs are often prescribed to boys who can’t sit still in boring and unstimulating school classes.

These are just three examples emblematic of the problems of overuse and inappropriate use of pharmaceuticals, in which we see major waste in drug spending and possible harm to the population.

Even though physicians want to do the right thing, and we consumers are often reluctant to take drugs if we don’t absolutely need them, why do we see so much irrational pharmaceutical consumption? What if I told you part of the answer comes down to politics? For a provincial government that spends upwards of $1.5 billion per year on medications, decisions around drug coverage and prescribing policies are often political, not medical.

Ensuring that drugs are only prescribed when needed, to patients who would derive great benefit from taking them, needs to be reinforced by a system based on good scientific evidence, not politics. So how do we get there?

What we’ve seen in BC and around the world is that when a democratically elected government enacts policies that lead to rational and better prescribing (sometimes causing drug companies to see their profits suffer), the pharmaceutical industry will not hesitate to resort to all manner of political games. And when those fail, they use the courts.

We saw this in 1996 when BC PharmaCare was sued by Big Pharma under the banner of PMAC (Pharmaceutical Manufacturers Association of Canada) for implementing evidence-based drug coverage rules that saved the taxpayers millions. At stake was a policy of paying for a ‘reference’ price in a class of drugs, forcing the competing drug makers to lower their prices. It worked and was supported by both the public and the courts (Big Pharma lost the lawsuit), but it also sent a clear message to future governments: you will anger us at your peril.

About a decade ago, Big Pharma also sued the National Institutes of Clinical Excellence (NICE) in the UK. This group examines the evidence of benefit and harm of new pharmaceuticals and then makes recommendations on whether the drugs should be covered in UK’s National Health System. They have turned down drugs for colon cancer (Avastin) that show little benefit and drugs for Alzheimer’s (Aricept), which are widely prescribed but almost completely ineffective, if not harmful. Whenever a government has good scientific evidence to show that coverage of a drug or certain class of drugs is not in the public interest, one major tactic from Big Pharma is to destroy the group that produces the evidence.

That’s one tactic we’ve seen here in BC with our own group, the Therapeutics Initiative (TI) at UBC, whose commitment to the evidence make them a natural drug industry target. Over the years, the drug lobbyists, speaking into the ears of legislators, have said the TI has an anti-drug bias and isn’t transparent when it comes to assessing new drugs, but I would disagree. As a group that favours conservative, rational prescribing, in contrast to the hucksters out there, the TI’s advice to doctors is that they shouldn’t use a new drug until there is positive (and independent) evidence of benefit.

Now that we have a new government in BC, or at least the political structure where compromise and consensus will be necessary, it’s prime time to create a system shielded from the political power of the pharmaceutical industry. Because pharmaceuticals are such a vital, costly and central part of our health system, any reforms brought in on the provincial health front must be structured to reduce the waste and inefficiency in the drug budget. And those reforms must be resilient, above politics so to speak, to ensure they can’t be thrown aside the moment one drug company is upset because their blockbuster drug isn’t deemed worthy of public coverage, and they send their lobbyists to sort out the Minister of Health or the Premier.

There is a short list of examples of models from around the world to emulate. A group in Ontario called ICES (Institute for Clinical Evaluative Sciences) gets provincial money to evaluate drug evidence and medical procedures and they are independent from government. The scientists who work there are (generally) protected from the mud-wrestling of provincial or pharmaceutical politics so their reports can be trusted. And as previously mentioned, there is NICE, established in the late 1990s as part of the UK’s Department of Health, and now called NIHC, the National Institutes for Health and Care Excellence). While it has weathered political attacks, the structure of the organization as an independent agency allows it to sustain pharma’s frequent criticism, emboldened to serve the health care needs of UK’s citizens.

The new NDP-Green accord is getting set to run the province. One of their platforms is to get back to essentials and implement an “essential drug program.” This is a fabulous idea, but in order to determine what is essential from the drug cabinet, you need weapons-grade expertise and a resilient political structure to be able to withstand Pharma’s political slings and arrows. Making provincial-level decisions about what new drugs to cover, needs, most of all, scientific certainty, untainted by the manufacturer’s one-sided view of the value of their products.

Such a structure should be like the Therapeutics Initiative, funded for studying evidence and supplying government decision makers with distilled summaries of research to support the hard decisions on drug funding. The TI’s UBC affiliations have been helpful in fending off pharma attacks, but this new institution would need multi-year, stable funding. You could easily fund such an institution by halting the automatic coverage of classes of drugs that are deemed unnecessary, unhelpful and possibly harmful. Hmm, maybe statins for everyone, antihypertensives in the elderly or ADHD drugs in children?

Providing independent and science-based decisions around drug coverage decisions would make such an institution a big target of Pharma’s attacks. In fact, the more successful it is in asserting evidence around the value and cost effectiveness of new drugs, the more it will be hated by Big Pharma, and their minions, including specialists and patient groups who are often used as Pharma’s foot soldiers in battling for the control of the public narrative.

Why is now the time for such an initiative? For starters, the Green Party says they are committed to evidence-based policy and so it makes sense they’d be natural supporters of making evidence and evaluation centrepieces of healthcare services. They want to get the ‘big money’ out of politics and policymaking so what would be better than an agency free from political influence to produce evidence on policy and program effectiveness, protected from Big Pharma and other vested interests?

We’ve seen groups like NICE or ICES have a big influence on policy and practice, free from the whipsawing of politics and able to focus on local policies and programs. In BC, we have another great asset in our PharmaNet system so that rapid, low-cost evaluations of drug policies can happen. We’ve been world leaders and we have some of the best scientists able to use these administrative databases to study drug policy. What we need now is a politics-free institute to house them. A great opportunity for a new government in this province.


Alan Cassels is a writer and former drug policy researcher. His latest book is The Cochrane Collaboration: Medicine’s Best Kept Secret. Follow him on twitter @AKECassels

Medical variation

All healthcare systems and doctors are not created equal

DRUG BUST
by Alan Cassels

Let’s compare doctor A and doctor B.

A 70-year-old man with high blood pressure and high cholesterol goes to see Dr. A. Even though the man is otherwise healthy, Dr. A thinks a few pills might bring down his blood pressure so he prescribes hydrochlorothiazide (a diuretic) and ramipril (an ACE-Inhibitor). He also writes a script for rosuvastatin for the high cholesterol. Because high blood pressure and elevated cholesterol are associated with an increased risk of heart attacks, the doctor is trying to reduce those risks. Later, the patient complains about his aching muscles – possibly caused by the statin – so Doc A also prescribes an anti-inflammatory drug. This man has two ‘conditions’ identified and four drugs recommended.

Imagine, instead, that the same man went to see Dr. B. This doctor doesn’t seem too worried by this patient’s high blood pressure. After all, ‘high-normal’ doesn’t constitute much risk so he tells the man to exercise more and watch how much salt he puts in his food. He jokes that, if his patient got off the couch more often and lost 10 pounds, his blood pressure would probably come back to normal. He also doesn’t think his high cholesterol is worth treating and he tells him not to stop eating the foods he loves just because of cholesterol worries. So with doctor B, the patient walks out of the clinic with the same condition, but no drugs whatsoever.

Of course, the big question we all have is “Does the 70-year-old man with high blood pressure and cholesterol live longer (or better) under doctors who practise like Dr. A or Dr. B?”

This is known as “medical variation,” a very important aspect of the practice of medicine. And it is worth studying if you want to make healthcare safer, of higher value and more effective. Studying the differences between healthcare systems can tell us a lot about whether high-spending areas versus low-spending areas get better or worse outcomes. The most famous of medical variation studies is probably the Dartmouth Atlas, which 20 years ago began looking at the differences in medical variations across the US. It found that although some states spent three times more per capita on certain medical procedures, those patients were no healthier and didn’t live any longer.

Last month, a report entitled “Unnecessary Care in Canada” came out, created by the people at the Canadian Institutes of Health Information and Choosing Wisely Canada. Choosing Wisely is a “national, clinician-led campaign committed to helping patients and clinicians engage in conversations about unnecessary care.” For the last few years, the group has compiled lists from almost every medical speciality on what is considered unnecessary or questionable care. For example, ordering a patient to have a CT scan for a mild head injury or an X-ray for lower back pain are unlikely to produce information of any value and shouldn’t be routinely done. With over 70 specialties producing lists of questionable care (see www.choosingwiselycanada.org), I’d encourage anyone who might be facing a medical procedure or test to see whether it might be considered unnecessary and potentially harmful. It might be too early to say if these lists are affecting the kind of care Canadians are getting, but I’m hoping they are giving ammunition to patients – and a good rationale for doctors – to start asking, “Is that test, drug or procedure really necessary?”

Knowing that unneeded tests or treatments can be harmful and lead to more wasted health care resources, the Choosing Wisely people have also examined the fact of medical variation in Canada.

One example is what is called preoperative testing, the kinds of tests and blood lab work you may be asked to undergo before you have an operation. If you’re asked to take tests, have X-rays or give blood samples before surgery, do they actually make a noticeable difference in the kind of healthcare that results? Choosing Wisely’s report said that one in three patients having eye surgery had a preoperative test in Ontario, yet that rate in Alberta for the same surgery is about one in five. Do patients in Ontario do that much better than patients in Alberta? Not at all.

There are some very good reasons why two different healthcare professionals (or clinics, hospitals or even health systems) treat the same patient in vastly different ways. For one, the doctors may have different training, they may be more or less influenced or aware of evidence-based recommendations or guidelines or they may just be expressing the culture of the clinic or group they work with. Health agencies’ policies, insurance and patient demand all go into determining the rate at which certain tests, treatments or drugs are ordered.

I called up Don Husereau in Ontario – he’s an expert on using and interpreting health research and also a former pharmacist – and asked what he thought about medical variation.

“It sometimes gets abused,” Don tells me. “They find variation and then say it’s just ‘uninformed clinicians’ who are deviating from a ‘gold standard.’ But sometimes there is something not accounted for in the variation. This notion that they are doing it poorly and are not evidence based and that they are ‘stupid’ is an overinterpretation of data.”

He says that, ultimately, “Data sometimes doesn’t tell the whole story.” There may be real differences between patients and he sees this in reference to vascular surgeons he works with. He says, “Some take high risk patients. Some won’t. Some might do more heroic things or seek out the highest risk patients.

“When we looked at the adoption of a new minimally-invasive approach to repairing damaged aortas, it is clear Canadian doctors were less enthusiastic than their US counterparts.” He went on to say, “Canadian doctors used the new approach half as much, were likely less susceptible to promotion and peer pressure and knew there was no clear evidence that either approach was better.”

I agree with Don Husereau that we have to be very careful when we compare doctors or health systems because there may be other factors affecting how much or what kind of medicine is being offered.

For me, a major difference comes down to the patient and their preferences. Even though doctors are trained to encourage “patient empowerment,” they may not have enough time to really probe what it is their patient actually wants. If the doctor feels the patient won’t be satisfied leaving without a script, guess what happens? They’re likely going to get one. Equally true is that if your physician doesn’t think you really want any drugs, she is also likely going to respect that, hopefully explaining the pros and cons of avoiding a new prescription.

So the next time you’re waiting at the doctor’s clinic, take some time to think about variation. Ask yourself if what you’re being offered is due to the doctor, the culture or the rules or regulations of a clinic? And maybe ask yourself what you can do to respectfully present your preferences. Take a look at what Choosing Wisely says about the conditions you’re interested in because those lists will remind you of a very important fact: some of the medical care being offered may not be necessary or perhaps is even harmful and worth asking questions about.

We should expect some degree of variation in the kind of care our doctors and health systems deliver. We can accept that every patient is different.

Whether you go to Doctor A or Doctor B, your job is to learn what you can. Take the effort to make your preferences known –in very clear ways – because at the end of the day, you are the one that has to swallow the medicine.

For you, asking questions and questioning answers are about the most important things you can do to stay healthy.

Alan Cassels is a former drug policy researcher, a writer and the author of several books on the pharmaceutical industry. www.alancassels.com

Which party has your back on health care?

DRUG BUST
by Alan Cassels

There are stark contrasts between the BC Liberals and the NDP

Let us say to the people not ‘How much have you got?’ but ‘How best can we serve you?’
– Dr. Norman Bethune

An election is looming and this may be one of the most crucial turning points in our province’s history. The market for prescription drugs is worth about $4 billion in annual spending in BC, and the way governments set policies around prescription drug approval, coverage and safety are vital to all of our futures. So the question is “Who do you trust?”

Below are six insights I’ve gathered over the last 23 years of watching provincial pharmaceutical policy, under both the NDP and Liberal governments. You may want to think of these when you step into the voting booth on May 9.

1. Evidence: When the NDP formed government in the early ‘90s, it was notable in how quickly they fostered a culture of evidence based policymaking at the Ministry of Health. They established an independent drug watchdog (UBC’s Therapeutics Initiative) and made sure science based decisions were going to undergird provincial drug coverage decisions. When the Liberals took power 16 years ago, they started to erode that base almost immediately, appointing drug industry lobbyists to oversee a panel on Pharmacare reform, sidelining the Therapeutics Initiative and ramping up the pharmaceutical industry’s involvement in drug coverage decisions. The quality of pharmaceutical governance under the BC Liberals, concerning approval, monitoring and safety of prescription drugs, has been an epic failure, and is the best way to explain why BC leads the country in opioid deaths.

2. Lobbying: Under the NDP, you almost never saw drug lobbyists wandering the halls of the Ministry of Health. Back in the ‘90s, the head of Pharmacare forbade his staff from meeting with them. The noticeable absence of pharmaceutical reps in the apparatus of government meant the ministry could get on with its job, unbefuddled by marketing messages and lobbying pressures. What a contrast to today where the BC Liberals have kicked open the door and invited industry officials, their experts and their funded patient reps right into the heart of government. The result? Even though the Liberals spout the aphorisms of evidence based policymaking, we can’t avoid watching a steady stream of often useless and expensive medicines being approved for coverage, and wasteful health spending decisions that may please Big Pharma’s lobbyist donors, but deliver little impact on public health.

3. Drug research: Under the NDP, BC established an internationally recognized cohort of independent drug policy researchers who studied changes in drug coverage policies, such as Reference-Based Pricing, which was responsible for eliminating much waste in the system. We studied the safety of drugs for acne (which cause birth defects), smoking cessation products (which cause psychiatric episodes) and drugs for ADHD (which are inappropriately prescribed), yet the message was loud and clear. The Liberals and their “partners” in the pharmaceutical industry didn’t want any independent research sullying their brands and most of that independent research was killed during the Health Ministry firing scandal in 2012. Meanwhile, millions in funding was ponied up for UBC’s Centre for Drug Research and Development designed to recycle our tax dollars into commercially viable products for private companies.

4. “Patient” groups: From the ‘90s onward, I remember seeing groups, such as the Osteoporosis Society, the BC Alzheimer’s Society and assorted astroturf patient groups, viciously attack the NDP. While patient groups can do good work for the diseases they represent, because so many of them are soaking in Big Pharma funding, they found allies in the Liberals. When the BC Liberals took office and warmly invited these patient groups into consultations and asked for their opinions about the latest pharmaceuticals, they were made to feel special. Sadly, the fine folks at BC Pharmacare who feel they are genuinely working in the public interest have been silently worn down by a steady stream of industry funded opinions and the drug-addled patient groups just make things worse.

5. Transparency: Under NDP premier Mike Harcourt, BC produced “model legislation for access to information,” according to the Vancouver Sun’s Vaughn Palmer. Palmer is certainly one who knows what a farce it is trying to access government documents through Freedom of Information (FOI). Hiding misdeeds from the public has become high art under the Liberals where politicians and bureaucrats routinely omit to write things down, use personal email or cell phones and “triple delete” to avoid anyone learning about government business. This corruption helps to partly explain why drug coverage decisions are often suspect and how the mysterious health firing scandal from 2012 remains the most expensive scandal in the BC Ministry of Health’s history.

BC’s Ombudsman may soon release his report on who called in the drone strike on the Health Ministry, resulting in the firing of eight drug safety researchers and millions of dollars of associated costs. Don’t tell me that the influence of pharmaceutical companies, many of which donate to the political BC Liberal Party, may not have wanted their products independently analyzed by those researchers. One of them, Rod MacIsaac, committed suicide before he could complete a study on Pfizer’s controversial smoking cessation drug. And yes, Pfizer, one of the world’s biggest pharmaceutical companies, has multiple ties to people within the BC Liberals. Quelle surprise!


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6. Wastebusting: One thing I noticed under the BC NDP’s culture of evidence based drug decision-making was a commitment to reduce waste. Not all new prescription products coming to market (happening all the time) are going to be worthy of coverage. Paying for the most expensive newer medicines, which aren’t any more effective or safer than those currently covered, only benefits the manufacturers. The BC Liberals have eroded this culture of wastebusting, allowing itself to be swindled on million-dollar drug coverage decisions. Is this because they’ve spent too much time cozying up to the drug companies and listening to the entreaties of officials, lobbyists and patient groups? Suffice to say every dollar spent on a useless, unnecessary drug is a dollar that isn’t going to be used where it is actually needed in the healthcare system. The Liberals don’t get this, while the NDP, in my opinion, always did.

Finally, when it comes to elections and political discussion, we all need to talk about what underpins health coverage decisions. Is it the needs of manufacturers and their armies of lobbyists? A conservative estimate would say we waste about $10 billion per year on what are sometimes unnecessary, useless or potentially harmful medicines, diagnostic tests and procedures. Every single person working in the health system has seen this shameful waste, yet the independent analysis and research needed to keep people from taking harmful drugs or useless tests no longer exists under the Liberals.

If a new government were to start by eliminating the pharmaceutical corruption of our health decision making, we’d be able to spend millions more on what is actually needed: more affordable drugs, better care for seniors, thorough homecare, manageable childcare and getting serious about affordable housing in BC. Let’s be clear, Alan Cassels is not about sticking it to the pharmaceutical industry. I’m about defeating waste because much of the money we send to the drug companies isn’t being used where it needs to be.

The BC Liberals have, for the last 16 years, shown their capacity to be tainted by drug industry messages, lobbyists and donations. At the end of the day, we need clean, clear health decisions as urgently as we need clean, clear water.

That’s what I think, but what do you think? Visit my website www.alancassels.com and answer my survey. Or tweet me at @AKECassels and put this in the tweet: #healthcarewastebusting Tell me what we need to do to make BC’s drug coverage affordable and appropriate. We need a dialogue on avoiding waste and I need your voices.

Eating our way to better mental health

Science shows we can

DRUG BUST
by Alan Cassels

Let food be thy medicine and medicine be thy food. – Hippocrates

There are very few golden bullets in medicine, very few. But some pharmaceuticals are extremely useful, especially if you’ve got type 1 diabetes, heart disease, severe pain or asthma. Then your drugs may be saving your life.

But, as I’ve said before, the problem with an overly drug-centric approach to healthcare is that it relentlessly eclipses other options. Much of our medical care is underpinned by research dominated by drug makers with the resources to conduct large, randomized, controlled trials. We need those studies, but we find the treatments that do not fit the profit paradigm are starved for respect and research funds, meaning the bias deepens and we end up with the kind of health care that society has decided to pay for.

Particularly problematic in our pharma-centric world are psychiatric treatments, often studied in questionable trials for short periods of time on people with indeterminate diagnoses. They are then used incredibly liberally even when evidence emerges, as it has with antidepressants and antipsychotics, that many people are being hurt by them.

Increasingly, even though society is swallowing growing amounts of drugs for such conditions as anxiety, depression, ADHD, mood and anxiety disorders, the prevalence of those disorders continues to climb. Where is the kid asking why the Emperor is naked? If we’re spending so much more every year on drugs for psychiatric illness, why aren’t the rates of mental illness dropping? Something is wrong here.

I think about this in the context of some friends of mine. They are having a terrible time with their daughter, who is so anxious she can’t go to school. I’m not sure what’s going on, but it appears she’s in a real rough space. She’s been taken to the hospital on numerous occasions and there have been several attempts to get her to see a child psychiatrist. She hasn’t been prescribed any drugs yet, but I’m pretty sure that when she finally gets in to see the psychiatrist, she’ll begin her entrée into the world of psychiatric drugs.

This is the standard road travelled by many people who are depressed, anxious, sleepless or hyperactive, yet there may be other options worth exploring. Certainly, cognitive behavioural therapy (‘talk’ therapy) and exercise come to mind. We’re also witnessing the growing area in the use of micronutrients – the essential minerals and vitamins we consume in our food and its importance to our mental health.

Bonnie Kaplan, an emeritus professor at the University of Calgary, has spent much of her professional life studying micronutrients, particularly in the context of mental health. The body and brain require a fairly large array of vitamins, minerals and essential fatty acids and when we have deficits it’s possible our brains suffer even more than our bodies. In our phone conversation, Bonnie tells me, “This is all about nutrition above the neck. The brain is the biggest consumer of nutrients.”

Because people have genetic differences, respond to stress differently and, hence, have different micronutrient needs, it is plausible that many of us could have nutrient deficiencies that affect our mood. We have to remember that nutrients are involved in every biologic, chemical and physiologic process.

“There are 50 known genetic mutations in the realm of physical health, where an alteration in the ability of enzymes to grab and hold the nutrients that they need for optimal metabolism is impaired. They need extra nutrients to make the pathways work,” Bonnie says.

She brims with enthusiasm noting there are somewhere in the neighbourhood of 45 clinical trials testing micronutrients in a variety of mental health conditions, including insomnia, ADHD, psychotic disorders, mood and anxiety. And she’s seen the greatest benefits using them to treat irritability, mood dysregulation, bipolar-type symptoms and explosive rage.

As an example of the kind of research out there, she describes an “amazing study from Spain,” best known for studying links between nutrition and cardiovascular disease, but which has also evaluated links to mental health. The researchers took about 9,000 people with no mental disorders and looked closely at what they ate, quantifying their intake of prepared pastries, processed foods and other forms of junk food. They divided the participants into three groups, depending on their consumption of processed foods, and waited about six years to find out who would be diagnosed with a mood or anxiety disorder.

“Those in the study who consumed the least processed food had a very low probability of developing mood and anxiety disorders. The group in the middle were generally ok, too,” Bonnie told me. “But those with the highest intake of processed foods were at high risk of becoming depressed or anxious.”

Bonnie is well aware of the difficulty this research has in making any inroads in the pharma-dominated world of psychiatry. Whether it is Omega-3s, vitamin D or calcium, so much research energy is put into studying single nutrients at a time. Many times she has seen researchers unable to get funding to study broad-spectrum micronutrients because of the central research tendency – and perhaps human nature – to want to find a single magic bullet. One reviewer asked, while looking down the list of 40 or so micronutrients in a nutritional formula proposed for a study, “Which is the important one?”

“They’re all important!” Bonnie exclaims. There is a strong rationale for studying a large batch of micronutrients together, which comes in a ‘broad spectrum formula,’ because the body requires all kinds of vitamins and minerals to work properly.

Another surprising finding came from a study in adults with psychotic disorders. Everyone was initially given a broad-spectrum micronutrient supplement. After a month, they were supposed to be randomized to receive either the supplement or a placebo in a blinded fashion. The wheels fell off the study when the patients refused to be randomized because they didn’t want to take a chance in giving up the formula. If the study participants themselves are that adamant about the effectiveness of the formula, there is probably something there!

There are a number of companies that produce broad-spectrum formulas containing vitamins, minerals and antioxidants and one might wonder how much bias seeps into this research, as we see in the pharmaceutical world, when the manufacturer pays for the research, gives out research grants and otherwise shapes the research in ways that support its product?

Having witnessed the intertwining of the pharmaceutical industry and the mental health world, and the resulting corruption of the mental health scientific literature, Kaplan and her colleagues have insisted on putting a firewall between the manufacturers and the research: they won’t accept research money from those making micronutrient formulas.

Researchers like Bonnie Kaplan are doing exactly the type of research the world needs more of. Most probably, there is a great link between nutrition and mental health. The way we currently treat mental illness needs a complete rethink and it must include better research and a better use of a range of treatments – even things we eat.

Kaplan sees the huge price governments and individuals are currently paying for the relatively ineffective pharmaceutical model of psychiatric care. They need to know that micronutrients, while no magic bullet, could be a very effective and safe way to help many people with mental health challenges. In two published studies, they have shown that micronutrient treatment was not only more effective, but it also cost less than10% of conventional care. It seems that governments could save a bundle if they helped contribute to the research and the treatments.

Kaplan has established two donor-advised charitable funds and has already raised over half a million dollars to support the clinical trials of junior colleagues around the world who are passionate about studying the use of nutrition for mental health. Contact her at kaplan@ucalgary.ca or donate directly to this kind of research through the Calgary Foundation.

Alan Cassels is a former drug policy researcher, a writer and the author of several books on the pharmaceutical industry.

Getting to the bottom of the opioid crisis

It starts by looking at prescribing practices

DRUG BUST
by Alan Cassels

More than a decade ago, UBC’s Therapeutics Initiative (TI) published a very alarming newsletter. It made virtually no waves at the time, but it struck me as a dire prediction of the state of prescribing in British Columbia.

The newsletter simply asked two questions about benzodiazepine use in BC. This class of drugs include products like Ativan and Valium ­– or generic drugs that end in ‘pam’ – and zopiclone and are typically prescribed for anxiety and insomnia. The TI asked how many people in BC were using benzos and of those, how many were using them contrary to recommendations?

As prescription drugs go, benzos are widely, widely used even though they are recommended only for “short-term” use, typically less than 14 days. The benzos are not supposed to be taken over the long term because they are considered highly “habit forming,” the euphemistic way of saying they can be addictive. Once you take them for too long, stopping can be hell and those who try to quit abruptly will face withdrawal symptoms so bad they’ll just go back on the drug.

Over time, benzodiazepines lose their effectiveness, yet there is good evidence that when a patient becomes tolerant, the doctor may just increase the dose. Long-term use of the drugs can cause learning, memory and attention problems and their use is linked to falls, injuries, hip fractures and other types of accidents. The other important thing is that the benzos are frequently found on the street and up to 80% of street drug users are also taking benzos.

The TI’s analysis found that nearly 10% of the BC population – about 400,000 people at the time – used benzos (based on 2002 data) and of those, 170,000 people received amounts “incompatible with short-term or intermittent use.” In other words, almost 5% of the BC population were essentially at risk of being physically dependent on a drug they got from a prescription pad.

The current opioid crisis seems a modern version of the same phenomenon replaying itself, but this time the stakes are much, much higher. Even though we have some of the best monitoring systems in the country – e.g. BC PharmaNet, a computerized, province-wide drug data system – it doesn’t stop dangerously poor prescribing and poor monitoring by those whose job it is to protect patients: the BC College of Physicians and Surgeons.

Searching for insight into BC’s current opioid crisis, I came across a 2015 report titled “Together We Can Do This,” written by a panel of 73 experts in addiction medicine and pharmaceutical policy in BC. It helpfully maps out why BC broke all records in overdose deaths last year (914) and why, unless there is drastic action to improve prescribing, people in this province will continue to die from overdoses in massive rates. These experts lay out a series of strategies to address BC’s opioid addiction, an urgent cause given we’ve got among the highest overdose-related death rates in the world.

The report noted BC “dispenses more than double the amount of opioids compared to Quebec, the lowest opioid dispensing province. Additionally, from 2005 to 2011, the rate of dispensing strong opioids in BC increased by almost 50% overall, including a 135% increase in oxycodone dispensation.”

Now, with thousands of addicts in BC and daily reports of new deaths, there is a lot of pre-election interest on the part of the reigning BC Liberals, as money is doled out for safe injection sites, naloxone kits – the drug to revive a person who is overdosing – and increasing the training of emergency personnel. BC’s provincial health officer is talking about “clean heroin” and giving addicts provincially subsidized opioids, yet all this energy trying to clean up the damage misses the point that it was mostly created in the first place by poor prescribing and poor drug policies.

That’s the view of this expert panel, which concluded, “Despite the scale of the present public health problem, strategies to meaningfully address unsafe prescribing have not been implemented.” They add that many people who are addicted to heroin or other intravenous drugs started out with pharmaceutical opioids and “ultimately, prescribers are largely responsible for the burgeoning illicit market in pharmaceutical opioids that has developed on the streets of BC.” And here’s the kicker: “The entry of organized crime groups into the manufacturing of counterfeit pharmaceutical opioids, which often contain fentanyl, to fuel the street market for illicit or diverted opioids is arguably a direct result of long-standing, unsafe physician prescribing practices.”

Added all together, the crisis is a political and medical boondoggle. Like the dangerous abundance of benzodiazepine use in BC the TI documented a decade ago, we are seeing the same sort of lax approach to prescribing around the opioids. The headlines may focus on the illicit fentanyl-spiked drugs killing citizens at astonishing rates, but the real story is in the high rate of opioid abuse and addiction happening in the wider BC population. In the wider pool of opioid addicts are our friends and neighbours who have thousands of prescription pills, including Dilaudid, Oxycontin, morphine, T-3s and many other opioid pills, sitting in their medicine cabinets, leaving them and other family members who might want to experiment open to abuse.

In my small circle of friends, I know of at least two men who had hip surgery last year and both were discharged with scripts of 100 pills of Oxycontin, enough to turn both of those men into addicts. I know teenagers who were given Oxycontin following wisdom teeth extraction. And another friend, a very successful professional, came within inches of being addicted to the painkillers he was prescribed for a lower back problem.

What can we do if those prescribing the opioids simply don’t know the potential harm they could be causing? It has been well documented that our physicians’ dependence on weapons-grade opioids has been shaped by the drug industry. In the mid-1990s, Purdue Pharma, the makers of Oxycontin, spent millions underwriting Canada’s pain guidelines, paying “key opinion leaders” in the physician community to downplay the dangers of opioids and infiltrating medical school textbooks and medical schools, teaching our young doctors about managing pain. Opioids are very effective for pain, but for many people, there are many cheaper, safer, simpler and far less addictive medicines that can effectively treat pain instead of the expensive patented opioids pushed by their makers.

To my mind, the biggest scandal is that physicians continue to allow themselves to listen to pharmaceutical industry messages and to be educated by the drug salesmen and tainted experts. Many doctors won’t be schmoozed by drug reps, but others don’t see a problem. Hence, this is not the last prescribing disaster we will have to deal with.

I wish I could say the BC Liberals are doing all the right things, carefully monitoring prescribing and using their considerable clout through PharmaCare to stop this carnage. But they’re not. Beholden to pharma’s donations, they act as if powerless to stop the flow of prescribed opioids. We used to have programs in place that monitored prescribing, but there has been no political will to restart them. BC PharmaCare no longer takes advice from the Therapeutics Initiative and we’ve seen the slow death of drug safety evaluations in BC since the 2012 Ministry of Health firing scandal.

The BC College of Physicians and Surgeons will pretend to be tough with new guidelines and try to crack the whip on flagrantly bad opioid prescribing, but it may just drive even more people to the street to find the pain relievers they’ve become addicted to.

We’ve got many reasons to vote in a new government in May. Our spectacular rate of overdose deaths continues to climb. It is a national shame that deserves local blame. Christy Clark’s government’s addiction to donor dollars continues to make us a laughingstock of the world and the only ones not laughing are the dead, the dying and the addicted.

Alan Cassels is an author and drug policy researcher in Victoria.

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