The growing backlash against medical guidelines

Doctors need to “show more spine”

DRUG BUST by Alan Cassels

 

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

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

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

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

What is going on here?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

—

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