Medication civil disobedience

DRUG BUST
by Alan Cassels

One of the first duties of the physician is to educate the masses not to take medicine. – Dr. William OslerYou may have heard about Stanley Milgram, the American psychologist who carried out some of the most infamous research on obedience back in the 1960s, but have you heard of the psychiatrist Charles K. Hofling?

Hofling carried out a very interesting hospital-based experiment in 1966, in which hospital nurses were given orders by an unknown doctor to administer a potentially life-threatening dose of a drug to a particular patient. The fake doctor phoned the nurse on night duty and told her to administer 20 mg of “Astroten” – a fake drug – to a patient, promising he would drop by later for the required signature. A bottle of “Astroten” was in the drug cabinet with its label clearly stating that 10 mg was the maximum daily dose.

The result? Twenty-one out of the 22 nurses were prepared to give the patient the Astroten as ordered and actually had to be prevented from doing so during the experiment. Like Milgram’s experiments, Hofling showed that even when people have strong reasons to question authority – such as being asked to deliver a potentially lethal drug– they often won’t question the orders they received. You likely wouldn’t get the same result today, but undoubtedly one stark fact remains: the authority of doctors or specialists over nurses and patients can seem invincible.

While Milgram and Hofling’s experiments have been criticized for cruelly tricking people into following orders, they are incredibly insightful, showing that many of us are hard-wired to not question or disobey authority. After all, “just following orders” is the oldest excuse in the world to explain away bad behaviour, even that of Nazis and those who carried out atrocities on an industrial scale.

In the modern world of pharmaceutical consumption, complying with authority – following a doctor’s prescription, for example – is considered one of the highest duties of a patient. Despite all the new-age assurances around “informed consent” and “doctor-patient collaboration,” we still live in a world where expecting and rewarding obedience endure and thrive.

Patients who are ‘non-adherent’ to their doctors’ orders do so at the risk of souring their good relationship with their GPs. Healthcare professionals understandably expect compliance from patients because they believe that not listening to good medical advice could be risky. Yet in the prescribing world, how big and how bad is this problem?

“Medication non-adherence is truly an epidemic,” according to Mary De Vera, a pharmacoepidemiologist and assistant professor in the Faculty of Pharmaceutical Sciences at UBC. Last summer, she was awarded a university position funded by AbbVie, a major pharmaceutical company.

The “Professorship in Medication Adherence” focuses on, as far as I can tell, the problem of disobedient patients; this is a head scratcher worthy of being filed in the “truth is stranger than fiction” file. What’s clear to me is that Big Pharma’s business model depends on drug sales so they must do their best to squash disobedience. After all, disobedient patients who won’t buy their products are bad for business.

There are certainly times when refusing a prescription may be fatal – getting bitten by a poisonous snake and refusing the antidote or having an asthma attack and refusing a bronchodilator, for example – but the vast majority of prescription drugs don’t fall into that category.

Clearly, not adhering to your doctor’s script is wasteful from an economic point of view. As a patient, if you get a prescription from your doctor, pay for it, but then don’t take it, you’re wasting your doctor’s time and the drug insurer’s and your money. You might also be missing out on something that works to deal with your health complaint.

Dr. De Vera maintains that “non-adherence is a leading cause of preventable morbidity, mortality and cost,” but I would beg to differ. As Peter Gotzsche so colourfully outlines in his book Deadly Medicines and Organized Crime, prescription drugs are the third leading cause of death so how could refusing prescribed drugs be a leading cause of dying or getting sick?

But that’s the line the drug industry and its surrogates like to peddle. One of my colleagues has a good counter to this. He pointed to the arthritis drug Vioxx – likely 150,000 dead after three years on the market – and said, “Nobody died by not taking Vioxx.” How true. Now substitute Prepulsid, Bextra, Baycol, Rezulin (etc.) and dozens of pharmaceuticals removed from the market in the last decade because of their propensity to kill and this ‘medication non-adherence’ crusade seems almost preposterous.

The theme of “non-adherence” isn’t a sentiment that would sit well with the doctors I know because they’ve been raised drinking a different Kool-Aid where “shared decision making” rules. Instead of ‘non-adherence,’ progressive doctors are now talking about “minimally disruptive medicine” and ways to rationalize and reduce peoples’ prescription regimes because they are aware of one indisputable fact: more drugs often lead to more harm.

I looked for research to see if it was harmful to patients if they did not adhere to their prescriptions, but there is very little information available. A recent systematic review by the Cochrane Collaboration found that, even though only about half of all patients take their medication as prescribed, there was scant evidence to show that this made much of a difference. Only five of 180 studies on how to improve “adherence rates” could show any improvements in health outcomes for patients. As the authors noted, “Even the most effective interventions did not lead to large improvements in adherence and treatment outcomes.”

While it seems the pharmaceutical industry’s “take-your-meds” approach is working under the 1950s banner of “Father knows best,” a noticeable counter-movement called “de-prescribing” is starting to emerge. Because the problem of excessive medication use in the elderly is becoming more and more known, efforts to ‘deprescribe’ – especially among the overdrugged and frail elderly – are expanding. New educational programs and tools are springing up all over the place to help doctors recognize and act on the problems related to polypharmacy (multiple drug prescriptions) and to try and reduce the potential harm related to all those drugs.

Doctors are starting to recognize that the more drugs you take, the more problems such as drug-to-drug interactions, errors and serious adverse drug reactions you are likely to have. This means – especially in older people – more falls, confusion, delirium and otherwise feeling sicker. One of the biggest reasons many seniors end up in hospitals – and have prolonged stays there – is that they have actually taken the dozens of drugs as prescribed, probably from multiple doctors. As foolish and as crazy as it sounds, many of those drugs were given to deal with the side effects of drugs the patient is already taking!

Even though doctors are starting to work to reduce the risk of polypharmacy, we can all be involved. Here’s one suggestion for seniors and those who care for them. Try taking this line for a test-drive: “Doctor, I don’t want to take all these drugs because they make me feel bad – weak, dizzy, confused, restless, etc. Can you do a trial on me and cut out those drugs that are not essential to keep me alive or which control my symptoms? Can you help me do this?”

No reasonable doctor will refuse this request, if you ask nicely. This is not being disobedient to your doctor’s orders. It’s not about being “non adherent.” It’s about reminding yourself that sometimes you have to be the first one to say, “enough is enough.”

Alan Cassels is a drug policy researcher in Victoria. He is currently working with other researchers in BC and across Canada to develop and test deprescribing tools. Follow him on twitter @akecassels or read his other writings at www.alancassels.com

Cradle-to-grave DNA screening

DRUG BUST
by Alan Cassels

What are health authorities doing with all that information?

“This will only hurt a little,” says the nurse as she cradles a brand new baby girl, all glowing pink and wrinkly. “We’re just going to take a little blood from her heel,” she adds, as she swabs the tiny foot, no bigger than the nurse’s thumb.

With one poke, a few droplets of blood are squeezed onto a filter paper and the baby’s brief, high- decibel howl signals the nurse’s job is done here. The blood spot card dries and is quickly whisked off to the lab for analysis.

The nurse assures the new parents, a bit bemused and exhausted from the birth ordeal, the heel prick test is necessary to find certain congenital disorders they should know about right away. The test can be used to detect hypothyroidism, an inability to produce thyroid hormone or phenylketonuria (PKU), a problem with amino acid metabolism, both of which are worth finding out about sooner rather than later.

But how many tests will that little blood spot go through? According to Perinatal Services BC, the group that runs newborn screening in BC, the blood of all BC babies is tested for 22 different diseases. Other jurisdictions might screen the blood for as many as 100 different conditions.

If there are markers for cystic fibrosis and sickle cell disease or other treatable disorders, signalling the child will need special treatment in order to avoid developmental disorders, liver problems or brain damage, these tests might find them. But are there any downsides to starting so early in our cradle-to-grave medical screening culture?

Well, for one, it’s not cheap. BC’s revamped newborn screening program cost about $2.3 million to set up and it takes another $2 million per year to collect blood samples from about 45,000 BC babies annually. The tests might find a problem in roughly 20 babies who will have one of a handful of treatable conditions. Another 20 might be found with a rare disease and they might benefit from the discovery. But 40 kids a year, out of 45,000 tested, means that for every 1,100 babies screened, you might find one with an abnormality you can do something about. Not bad, but not all diseases screened for at childbirth are easily treatable and it is possible the test might miss something important or find something that turns out to be insignificant. Can we be confident that whomever controls this little baby’s genetic sample won’t make it available to insurers, health authorities or even the police sometime in the future? Hmmm, I think maybe not.

Regardless of the best intentions of our medical authorities, we can’t ignore powerful commercial interests swirling around the decoding of the human genome and the fact companies will pay handsomely for the kind of data generated by our databank that contains the DNA of all of our children. Health authorities, including the ones in BC, are tasked with an incredibly important job: ensuring babies’ blood samples are collected in the most ethical way (which usually means through fully informed consent) and guarded by the strongest protection possible. But how does it work out in the ‘real world?’

A lawsuit against the PHSA (Provincial Health Services Authority), on behalf of a parent is currently before the courts. It charges that the BC government has been collecting and storing newborn blood samples from BC and the Yukon without the consent of parents.

According to Jason Gratl, the Vancouver lawyer arguing the case, the consent provisions around newborn screening have improved somewhat since he filed his claim in May 2010, but he maintains the BC government “has a secret and long-term DNA storage bank that was obtained unlawfully.” He says this DNA information “can say a lot about the children who donated the blood, but it could also say something about their parents.” Are the samples being used in research?

Yes they are, Gratl admits, but he adds, “The precise conditions under which the samples are being used for research have yet to be explored.” He says he doesn’t think there’s anything malignant going on with the screening, but the “lack of consent over the long-term storage of the blood samples” is the real issue at stake. A judge will likely rule in the case this month.

While this lawsuit might improve consent provisions around newborn screening, there are a few general questions that anyone proposing population, “healthy-person” screening should answer, including:

Can the disease only be found with the test? Are there other more reliable ways to diagnose or predict this condition? Is the test always accurate in finding the disease in question? Does the disease occur with a high enough frequency in the general population? Does the disease have some urgency? Does it need to be found right away so things can be done to mitigate the disease’s burden?

The tests for PKU and hyperthyroidism are generally accepted because the tests are accurate and early intervention will help treat the kids with these conditions. But what about the range of DNA tests that could be performed on this baby’s blood? Is it wise to be carrying out genetic horoscoping on this baby just because we can?

GeneWatch UK, a non-profit group focused on genetic testing issues, has been a major critic of the modern push to use DNA to test everything. The organization wrote a paper in strong reaction to a government committee’s suggestion that all babies born in the UK should have their genome sequenced.

Helen Wallace, GeneWatch’s director, gets right to the heart of the issue when she says, “Genes are poor predictors of most illnesses so most children would get misleading information about their genetic risk.” She added, “Most diseases in most people depend much more on social and environmental factors. Better school dinners are much more important for most children than genetic testing.”

Should we be concerned about DNA testing of our babies in BC or anywhere else for that matter?

The answer is “It depends.” It depends how authorities intend to use our baby’s DNA. Will they eventually attach it to her electronic health record, fusing personal genetic and health information so research and monitoring of disease can be done more efficiently? In some eyes, that scenario would be ideal.

According to GeneWatch, “Billions in taxpayers’ money has been wasted in both Britain and the USA and medical privacy has been jeopardized, in an attempt to create the vast databases of electronic medical records linked to DNA that will supposedly allow scientists to ‘predict and prevent’ disease. A massive expansion in the drug market is predicted if everyone is tested.”

What is clear to me – perhaps best symbolized by this ritualistic bloodletting of a day-old infant – is that genetics is going mainstream and playing an increasingly larger role in medical screening and the provision of healthcare. The heel-prick hurts the baby temporarily, yet her first outside-the-womb screening test will surely not be her last. With modern healthcare systems driven to screen for any and all diseases, this baby will face a lifetime of attempts to find disease in her body.

Right now, parents hand over their infant’s DNA because it appears the benefits exceed the risks. The problem is we are not clear what we are risking. Will that little girl face a black cloud of a disease (which might be benign) hanging over her head or a greater lifetime risk of depression or anxiety? Or will she be discriminated against or stigmatized? Those are things we can’t yet answer.

Genetic screening of our babies may allow us to know many things even as it undermines something many of us hold as sacred: the right, sometimes, not to know.

Alan Cassels is the author of numerous books, including The ABCs of Disease Mongering, The Cochrane Collaboration, Selling Sickness and Seeking Sickness.

Healthcare poverty and inequity in the developing world

Neglected people, overlooked diseases

DRUG BUST
by Alan Cassels

Inequity. It’s a damnable word, a cruel word. A word that characterizes the most distasteful, egregious thing that we humans tolerate – namely, the very inequitable way human health is distributed across our planet. One part of the world drowns in medicines and potions for the most trivial of ‘diseases’ and conditions while the other part of the world dies for the lack of the most basic of life-sustaining things: clean water, adequate food, basic medicines. Inequity in the world is at the heart of the great divide between those who will live long and productive lives and those who won’t. Inequity is irascible, callous and shameful. It is entirely human-created and its existence diminishes our humanity.

Not only does modern society seem to accept inequity, but our policies also tend to breed it. Even as we delude ourselves with lofty pronouncements and say we are working hard to reduce inequity, in reality, we mostly just tolerate it.

The reality of life for those on the other side of the inequity divide – the world’s poorest countries – is the daily grappling with real epidemics, which leaves nothing extraneous to put towards a health risk that is merely a “potential” emergency. There, several million people die every year from diseases due to poor community hygiene and lack of clean water, in situations where dysentery, cholera and other entirely preventable water-borne diseases wreak an incredible burden of ill health throughout the developing world.

Can we really understand dire poverty in the same way as the inhabitants of poor countries who witness their children dying of diarrhoea for the lack of 25 cents worth of oral rehydration therapy? It is almost as if ‘we’ and ‘they’ lived on separate planets.

Far be it for me to proffer solutions for the most dire problems of planetary inequity, but let me suggest at least two interim suggestions for how Canada and Canadians could work to reduce that inequity: the first serious and the other more glib.

For immediate needs, we need to be creating more toilets.

Before you go thinking that’s the glib answer, consider this: the lack of access to toilets is one of the world’s most dire health emergencies. Many diseases of poverty wouldn’t survive or thrive if proper human sanitation denied them the opportunity to do so. Effective sanitation has long been recognized by physicians and other health experts around the world as the world’s most pressing health issue. Don’t believe me?

More than 11,000 readers of the prestigious British Medical Journal (whose readership consists mostly of physicians) were [once] asked to vote for what they thought were the most important medical advancements in the last 150 years. What won the contest? Antibiotics? Anaesthesia? Vaccines? Nope, nope, nope. Access to clean water and sewage disposal – “the sanitary revolution” – was judged the world’s most important medical achievement.

In her book, The Big Necessity: The Unmentionable World of Human Waste and Why It Matters, author Rose George notes that access to a toilet is not a laughing matter. It is a matter of life and death. Nearly half the world’s population, or about 2.6 billion people, lack access to a toilet and Rose George notes that nearly 80 percent of the world’s illnesses are caused by fecal matter. Diarrhoea, the key consequence of poor sanitation, is a lethal condition that kills 2.2 million people a year in the developing world – more than AIDS, tuberculosis or malaria.

I thought that such an urgent issue would mean that Canada’s development agency CIDA, which dispenses nearly $3 billion a year in foreign aid, would be a major contributor to the world’s sanitation revolution. I was dead wrong. Canadian taxpayer-funded aid, directed towards solutions that flush, gets almost nothing. In fact, the Global Sanitation Fund, claimed as one of the best global sanitation initiatives in existence, has never seen Canada contribute a single penny. That stinks. And, perhaps most of all, it shows Canadian unwillingness to contribute to what is probably seen in development circles as a very ‘unsexy’ cause. C’mon – saving lives with low-tech, high impact solutions is very, very sexy.

You might say that, after sanitation and clean water, what the poorest of the poor need is access to proper food and medicine. The unique forms of medicine, which would actually address the neglected diseases that afflict the poor most, are almost nowhere to be seen on the pharmaceutical research and development agenda. Again, inequity raises its ugly head and the poorest are left to suffer.

Modern medical science has been missing-in-action for quite a while when it comes to creating new treatments for diseases afflicting the very poor. According to the medical humanitarian group Médecins Sans Frontières (MSF), of all new medicines developed between 1975 and 1999, only one percent was developed for tropical neglected diseases and tuberculosis.

So how do we ramp up the investment in the neglected diseases that most affect the poor?

The major impediment to directing resources towards diseases of the poor is the fact that the drug industry is largely uninterested. There’s no money in treating poor people. Some groups, such as the Institute for OneWorldHealth (www.oneworldhealth.org/) and MSF’s “Drugs for Neglected Diseases Initiative” (www.dndi.org) have recognized this reality and are on the front lines of using both public and private money to develop novel therapies for some of the most common tropical diseases.

While pharma companies understandably want a return on investments in research, the lack of any promising commercial returns for diseases of poverty seriously slows the flow of capital needed to develop and deliver those treatments. When you look at the historical development of tropical disease treatments, many were developed by the simple fact that we (we who inhabit the rich ‘developed’ world) felt threatened. The drugs currently available to prevent and treat malaria emerged out of the American and French experiences in Vietnam, where our scientists were given the resources they needed to create treatments which would keep their soldiers out of harm’s way.

The lesson here seems simple: being in foreign places may not be so good for our soldiers’ health, but it could be good for the development of treatments for infectious diseases that exist primarily in poor countries. When our armed forces are sent abroad, our governments suddenly become seriously interested in investing in researching new treatments.

I am proposing it is high time we started ‘catching’ the same diseases of the poor. Malaria in Southern Alabama? Now here comes some serious antimalarial research. Hmm, maybe that would be a positive side effect to climate change? Tuberculosis outbreak in Toronto? Watch out for the new development of novel antibiotics. Chagas disease in cottage country? Instant research money for that disease.

In terms of one of the world’s biggest killers, malaria, the World Malaria Report (2008) reported there were as many as 247 million cases of malaria across the globe. In light of this epidemic, the drug company GlaxoSmithKline is opening up access to an extensive dataset on 13,500 compounds, which could be potential malaria fighters. These data are on chemical entities that have been tested against the Plasmodium parasite that causes malaria and researchers will use it to help isolate those compounds most likely to work.

These are all very important developments and even as we may one day see research and development for neglected diseases becoming the highest of priorities – and the gross inequity in the health of the world’s population starts to shrink – we shouldn’t just sit here and wait for things to happen.

Let’s get cracking on exporting toilets and importing diseases. While improving access to clean water and sanitation can improve the fundamental building blocks of any healthy nation, let’s see a little more tuberculosis and malaria in North America and stimulate our research enterprises where, at the end of the day, the inequity of healthcare will shrink even further.

Just a thought.

Alan Cassels is the author of numerous books, including The ABCs of Disease Mongering, The Cochrane Collaboration, Selling Sickness and Seeking Sickness.

The new shingles vaccine: hype or good value for your money?

DRUG BUST
by Alan Cassels

A ‘game changing’ new vaccine arrived on the Canadian market last month, promising to relieve you of the pain associated with shingles. Shingles is caused by the varicella-zoster virus, which can appear as a blistering, painful rash that occasionally leads to complications. There is already a shingles vaccine on the market, but this new one, named Shingrix, is being promoted as “90% effective.” If it’s that good, why would anyone hesitate in getting it?

Since I have studied the marketing messages, I wondered whether Shingrix conforms to my theory that “the bigger the hype, the smaller the likely impact.”

If you were unaware of shingles up to now, that will soon likely change due to what seems to be a heavy, corporate-sponsored PR campaign designed to do what pharma campaigns do best: drive you to your doctor. In this case, by making the disease look incredibly painful and ubiquitous – one in three Canadians will get shingles we are told – our doctors’ offices will soon be flooded with people asking for this new vaccine.

Numerous talk shows on TV and radio, as well as newspaper and magazine articles, have warned of the dangers of the disease. The message here is simple and direct: if you want to avoid the dreaded shingles, you better get the shot. This is like other disease-mongering I’ve seen in the past where conditions like herpes, low testosterone or toenail fungus, among many other conditions, are running rampant and threatening the health and safety of populations. Fear sells and as any marketer knows, “You don’t sell the steak, you sell the sizzle.”

The corporate drug world is hoping this one pays off. FiercePharma (fiercepharma.com), a drug information news site, says that GSK, the manufacturer of Shingrix, “has big expectations for its new vaccine,” also noting, “Analysts have predicted more than $1 billion in 2022 sales for the shot.” Health departments around the country are understandably hesitant to pay for the vaccine because it’s expensive and would add millions to our annual provincial drug bill. There is no firm price yet set in Canada, but in the US, the cost is $280USD for the two-shot regime.

I can understand this hesitancy for three reasons. Given the nature of the research on the vaccine, surprisingly, few of us will ever get shingles (more on that in a bit). Secondly, given the research on the vaccine, based on a three-year trial in 14,000 people, the vaccine doesn’t seem very effective. The final, and perhaps the most worrisome thing, is the research which underpins the vaccine has a high risk of bias, which is to say, there is a high degree of doubt the results seen in the trial are even possible in the real world.

While governments everywhere will be asked to pay for this vaccine and seniors’ groups are already lobbying for coverage, I think we probably have better things to do with our health dollars.

For starters, the major clinical study paid for by manufacturer GSK shows a lot of promise, with newspaper headlines around the world promoting the vaccine as having an efficacy rate of “more than 90%.” That figure is essentially meaningless without important context. In the study of over 14,000 people over 50 who were followed for three years, half were given the vaccine and half the placebo. Of the 7,698 people who got the vaccine, nine developed shingles (a rate of about 0.1%). Of the 7,713 who got the placebo, 235 people got shingles (about 3%). This difference, of 2.9%, translates into what is called a NNV: numbers needed to vaccinate. In this case, it’s about 35, meaning that for every 35 people over 50 who get the two-shot dose of Shingrix, one case of the shingles will be prevented. Another way to say this is 34 out of 35 people will see no benefit whatsoever from the vaccine over three years.

One of the real concerns about shingles is whether it leads to complications such as neuralgia (nerve pain in your face or head). This only happens in about 10-15% of shingles cases and, in terms of the trial, it essentially showed doctors would have to vaccinate 261 people to prevent one case of neuralgia.

People bamboozled into thinking the vaccine is “90%” effective, as opposed to 2.9% effective, might be why we see seniors’ groups begging the government to pay for it. At a cost that could be as high as $300 for the two shots of Shingrix, this means millions of dollars if you were to vaccinate everyone over 50.

While shingles can be nasty and debilitating for some, if we take this study into account, most people don’t develop shingles. In this study, only about 1% of the placebo population develop shingles each year and while that rate may increase with age, can we say this is really a major public health problem deserving of millions of dollars of public money being spent?

There is one other nagging problem with the research on Shingrix: it hurts. In fact, the company’s own reports detailed the commonly reported side effects of the vaccination, which include “pain, redness and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever and upset stomach.” Over 80% of the patients given the shot had some level of pain, as opposed to about 10% of the placebo patients.

My reading of this is the vaccine does not dish out an ordinary “ouchie” typical of when someone puts a needle in your arm. Commentators have explained Shingrix is an ultra painful shot because it’s an ultra potent vaccine. Compared to the placebo, the severity of the side effects of the vaccine were much more intense. The study showed 17% of the patients injected with the vaccine, versus 3% on placebo, had “grade 3” symptoms, defined as symptoms that “prevented normal everyday activities.” This gives a rate of 14% who were harmed to this level. The NNH (number needed to harm) is seven. So for every seven persons injected with the vaccine, one person will have “grade 3” symptoms and have difficulty functioning in everyday activities.

I don’t think the fear of a painful needle should prevent you from getting any vaccine, but there is a problem with this high rate of injection injuries: it unblinds the study.

In other words, if a randomized controlled study is to be believed, patients and clinicians involved must be blind to which treatment individual patients receive. If you know that patients in group A suffer a much higher rate of a certain type of effect over patients in group B, it is much easier to discern whether they were getting the intervention or the placebo. In this case, if the treating doctor knows his patient is getting the vaccine versus the placebo, there may be subtle ways in which his assessment of the patient’s health changes. Basically, it injects a level of subjectivity into the results and we all know “unblinded” trials must always be treated with caution.

There is another type of bias at play here and it’s called “funding” bias. Also known as “sponsorship bias,” the fact is the manufacturer and the researchers had a financial incentive to see a certain result, unlike the independent researchers who were only interested in the ‘truth’ of the vaccine. Again, this means we have to be cautious in interpreting the results.

This is not to besmirch the reputation of the manufacturer or the investigators who studied the vaccine. But, as we do with any drug, we have to ask ourselves, “Is the research believable and if it is, is it likely to be of an overall benefit?”

This is what our doctors and you, the prospective patients, need to ask. Do you want to spend $300 on a vaccine for a one in 35 chance of benefit and a one in seven chance of being harmed? We all need to be involved in ensuring governments and individuals spend their health dollars wisely. And that is why when a new drug or a new vaccine comes around, promising to be ‘game changing,’ everyone would benefit from a sober second opinion.

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

Blood supply donors and privateers

DRUG BUST
by Alan Cassels

I get a regular phone call that I won’t answer. I know what the caller wants and I’m not willing to get into a discussion about why I don’t want to talk to them. The caller? Canadian Blood Service (CBS), an organization whose sole mission is to collect blood donations to meet the health needs of Canadians, a huge, vital service that depends on volunteers like me.

Last year, I got a nice little certificate from the Canadian Blood Service honouring me for my “generosity and commitment to helping others” in recognition of the 50 blood donations I’ve made over the last decade or so. The bargain always felt good: as a donor, I give them a pint of the red stuff, “the gift of life,” and, in return, I get some juice and a few cookies. But, for now, I’ve taken a hiatus. Let’s call it a one-man boycott.

In Canada, over the last few decades, we’ve seen the slow privatization of many things related to healthcare. Each time, when the moneylenders are let into the temple, a little bit of our public healthcare system dies. We are now seeing the beginnings of the privatization of our blood supply. Not quite blood, per se, but a component of blood: plasma. Plasma is the clear, yellowish liquid part of blood that remains after you’ve removed the red and white blood cells and platelets. Plasma is essential for delivering proteins for blood clotting and fighting diseases. It helps treat hemophilia, shock and trauma. It is also made into products, such as drugs to treat bleeding disorders and immune deficiencies. And that’s what has the moneylenders mighty interested.

An Iran-based pharmaceutical company called Canadian Plasma Resources has already set up plasma donation centres in New Brunswick and Saskatchewan and they want to set up more. The argument they give is that Canada needs to move towards self-sufficiency in blood products. Canada is currently 100% self-sufficient in fresh plasma, however, for the stuff needed to make plasma-based drug products, we currently import about 70% of those products from the US. The key difference between Canadian Plasma Resources (CPR) and the Canadian Blood Services is the plasma folks are a for-profit company and they pay donors to donate their plasma, which you can do about every two weeks. Once you’ve passed the initial screening, every donation you make will earn you a $50 VISA-card type reward. The company then turns that plasma around and makes plasma-based pharmaceuticals out of it, which they can then sell to other countries or back to Canadians. Sounds good, right?

There are many reasons some think allowing for-profit plasma donations in Canada is just plain wrong. In fact, it is indefensible. We’ve just celebrated the 20th anniversary of the Krever Inquiry on Canada’s notorious tainted blood scandal where over 2,000 Canadians contracted AIDs and another 30,000 or so got Hepatitis C from tainted blood. That report was a damning indictment of the way blood was screened and distributed in Canada and showed how good, old government incompetence, ass-covering and unaccountability conspired to kill and injure Canadians. But what have we learned? One of the key recommendations of the Krever report was that Canada should maintain a volunteer-only blood system in order to have a safe and guaranteed supply of blood and blood products.

Yet 20 years later, we see the Canadian government granting licenses to a private company so they can expand their private plasma drug business. In November, a shocking, in-depth article in Maclean’s magazine drew heavily from an 800-page freedom-of-information request and showed the extent to which our regulator – Health Canada – is trying to open the doors to the moneylenders. That article, examining correspondence between CBS and Health Canada, clearly showed Health Canada has been colluding with this company and essentially helping them establish their private blood donation clinics in Canada. Some provinces have responded by banning for-profit private blood donation clinics (Quebec, Ontario and Alberta so far), but that hasn’t stopped the other provinces from being courted.

Many people have argued that the for-profit system won’t be as safe as the purely voluntary system we have now, a position staunchly defended by the Canadian Blood Service, which maintains the blood Canadians voluntarily donate is so thoroughly screened, another tainted blood scandal is highly unlikely. Even though the level of blood screening is more thorough than perhaps 20 years ago, the safety of our blood supply is not the biggest issue. The bigger danger is that the volunteer aspect of our blood supply now has to compete with for-profit companies that pay donors.

The CBS already collects plasma and has seven voluntary donor plasma collection sites, but how long will they last when they have to compete against a private company setting up clinics near universities, luring students who need a few bucks? Adrienne Silnicki with the Canadian Health Coalition told me, “We have evidence that, in Saskatoon, CBS has seen a reduction in donations from their target demographic 17-24 year olds.” In other words, the worry that for-profit clinics will steal blood that volunteers would otherwise donate is justified.

CBS, in a letter to Maclean’s magazine, cited the example of Hungary which has seen its voluntary service drop off after the for-profit plasma organizations set up shop.

Publicly, the CBS has warned Health Canada and provincial governments they shouldn’t be allowing private collection of blood products, yet those requests seem to be falling on deaf ears. This has led groups like the Canadian Health Coalition and BloodWatch to start a campaign to oppose any expansion of for-profit plasma centres. In their press materials, they say our plasma will be sold overseas and once that happens, because of international trade deals, “We will not be able to safeguard and store Canadian plasma for Canadian use even in the event of a blood borne virus which may affect the international plasma supply.”

Adrienne Silnicki reminded me the Canadian Health Coalition’s mandate is to protect and expand public healthcare so they are naturally opposed to these for-profit clinics. The company, however, is blasting ahead. Apparently, they need 10 Canadian clinics to be profitable and are currently proposing a new clinic for Saint John in New Brunswick.

What can the feds do? Well, at the very least, the regulators can, well, regulate. The federal government can revoke the establishment licenses of these clinics and refuse to issue any new ones. But will this happen?

What was so appalling in the Maclean’s article was how “cosy” the relations were between the Canadian Blood Services and Canadian Plasma resources. Adrienne Silnicki called it a “disgusting cosiness,” noting, “We’re obviously very concerned about it.”

CBS immediately sent a letter to Maclean’s slamming the magazine for “fostering panic over unfounded safety concerns.” But why didn’t they slam Health Canada for mismanaging this file? Their response seems to be to just increase the amount of voluntary plasma donations they can get. Seems they have convinced the provincial health ministers to go along with that plan. A health minister meeting in Edmonton in October resulted in a consensus statement stating, “Immediate action is needed to improve and expand domestic plasma collection.” Good luck on that front.

This isn’t good enough for me. If the Canadian Blood Service wants to keep the voluntary blood donation system going, they will have to play hardball with the regulators in Canada and tell them, in no uncertain terms, that the viability of our voluntary blood system is in jeopardy.

Will this happen? Hmm, good question.

We have seen on the pharmaceutical file that Health Canada seems to think its job is to protect companies and not patients, so don’t expect them to crack down anytime soon on the moneylenders. Not unless they get the right pressure. It’s too bad CBS is caught in the middle, trying to be nice. But let’s face it, they’re cowards.

In the meantime, I’ll do without the cookies and the juice while they’ll have to do without my blood.

Alan Cassels is a pharmaceutical policy researcher in Victoria. www.alancassels.com

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