OVERVIEW
· Rather than using drugs as a last resort, our motto has become ‘drug me first, and worry about the consequences later’.
· Understand why we’re a society that has become hooked on prescription drugs.
· Discover why our prescription drug culture is short-sighted and why the answers to some of our most pressing health problems can’t be found in a prescription pad.
· We reveal how even preventive medicine is being hijacked by the drug industry.
· A safer, more effective and more palatable alternative exists – the best preventive medicine of all can be found in the foods we eat and the lifestyles we lead.
While I was studying pharmacy, I learned an important lesson that has stayed with me. Wide-eyed and full of enthusiasm, I eagerly got stuck into a real-life practical. Confronted with a patient suffering from acid reflux, I immediately responded with the sage advice: ‘A few days of acid suppressant tablets for you sir, and if things aren’t better come back to see me’. This triumphant foray into the world of dispensing drugs was short-lived, courtesy of my esteemed lecturer. Acid reflux may be a common-or-garden complaint, she patiently counselled, but investigating its cause and offering lifestyle advice to prevent it was still important. ‘Remember,’ she said, ‘medicines are there to be used as a last resort’.
The truth is there’s no such thing as a perfectly safe medicine and every drug is capable of causing side effects. Sure, some have been around a long time and we have a pretty exhaustive knowledge of them. But as for the newer ones, the full profile of adverse effects cannot be confidently known until they’ve spent years on the market. We’re afraid to say that makes us the guinea pigs. Just take the decade 1998–2008, when 40 drugs were withdrawn from the market due to the severe side effects they caused1. Side effects that simply hadn’t surfaced during the clinical trials designed to test their safety. Liver and heart problems accounted for 62% of the drugs withdrawn.
I could be pretty confident that those acid suppressant tablets would do the job with no untoward effects, but I now know that’s not really the point. It’s the false sense of security it can create, that’s the problem. Fine, go ahead, take the pills, job done. What if it happens again? Don’t worry, you know the tablets will take care of it. And so our trust in pharmaceutical solutions becomes embedded. With this attitude firmly entrenched, the patient need not fear future conditions. As long as there’s a pill for it, all is well in the world. It might start with something reasonably trivial, like a bit of troublesome heartburn. But what if next time it’s a more serious, chronic condition? A condition requiring long-term drug treatment that carries with it a higher risk of adverse side effects? Never fear, for we have another tablet that will take care of that… and as for those troublesome side effects, well, we have just the thing for those too. And so begins the slippery slope of deteriorating health and pharmaceutical dependence.
What if there was a different way? What if sometimes, all that’s needed in the first place is the implementation of some carefully considered diet and lifestyle changes? Don’t get us wrong, in the arsenal of patient care, drugs are vital and effective weapons, and we’d be a whole lot worse off without them. But with their risk of collateral damage, any good strategist can see that they should be the final resort. What an important lesson I learned – a worthy imperative that I figured was the backbone of patient care.
Boy was I in for a shock on entering the world of pharmacy…
Drug dependence
The inconvenient truth is that we live in a drug-dependent society. In 2008, over $234 billion was spent on prescription medications in the USA, more than double that of 19992. Within the last month, 48% of Americans will have taken a prescription medication. This includes one in five children and a staggering nine in ten people aged over 60. In 1994, 2.2 million people experienced serious side effects, and more than 100,000 people died from prescription medicines, just in hospitals alone3. Prescription drugs are one of the biggest killers in the USA, yet, instead of serving a stark warning for prescribing practices, the consumption of prescription medicines has since increased dramatically. The stats aren’t pretty and we find it more than a little difficult to reconcile this with the idea that we live in a healthy society in the twenty-first century.
Let’s be clear on one thing: we’re not on some all-out anti-drug crusade. There’s no question of the value of medicines and that the vast majority are legitimately prescribed. In fact, there are probably many patients out there who aren’t on optimal therapy and would be better served by added medications, or higher doses. But as a society, we’re living in the midst of a delusion. We baulk at the dangers of recreational drugs and regard them with nothing short of horror. But we’re content to remain oblivious to the harm they do once they come courtesy of a prescription pad. Instead of showing the proper respect for these potential killers, we turn to them on a whim. A culture of using drugs as a last resort has morphed into a disturbing culture of ‘drug me first’ prescription junkies.
It’s hardly a surprise that we’re popping pharmaceuticals as if they were candy. The ‘drug me first’ doctrine was epitomized in 1997, when the FDA (US Food and Drug Administration) allowed direct-to-consumer advertising of prescription medicines. What an absolutely astonishing decision from an organization that is ‘responsible for protecting the public health’ when it comes to medicine! (Thankfully, for now, this decision is unique to the USA and New Zealand; the EU and other countries still have sense enough to prohibit it.) Sure, we’re all for patients taking an active interest in their health, knowing their options and being better informed. But are we really expected to believe that the best way this information is disseminated is from the people whose job it is to make profits from selling us the drugs in the first place?
With shareholders, profit margins and market share to contend with, do we really think ‘big pharma’ is immune to the shameless manipulation that commercial companies utilize so adeptly in ruthlessly pushing their sales?
Considering that one of the greatest public advertising expenditures by the pharmaceutical industry is for erectile dysfunction pills (not exactly the greatest health plight in the USA), you’ll forgive us for thinking the industry’s motives are more commercial than ethical4.
The revolution will be televised
Advertising companies want you, the consumer, to use their products, and they’ll try every last trick in the book, including playing on your emotions, to make it happen5. Lest we forget, in the words of Canadian economist Stephen Leacock, advertising is ‘the science of arresting the human intelligence long enough to get money from it’.
For example, in the USA there is a frequently run commercial for an antidepressant (we won’t name the drug but if you live in the USA and watch TV, it’s run so often that you’ll likely know the one we mean). It is introduced by a soporific, melancholic tune. The image: the face of a woman gazing forlornly down the camera lens. A wind-up doll becomes the analogy; its hunched, strained movements merely enduring until the encroaching, spluttering end. This is a bleak and desolate world. But after drug intervention, everything changes. The music picks up in pace and timbre. The doll moves proudly, and with purpose. A sparkle fills the woman’s eyes. Sunshine and euphoria now replace the void. Oh, and a voice comes on, listing the possible side effects, which seem quite serious, and I’m pretty sure death is mentioned, but he speaks so quickly and the transformation is so overwhelming that the words seem arbitrary, irritating even. For at this time, all was good with life, and for a fleeting moment even we craved this ‘wonder drug’.
There’s a reason why the pharmaceutical industry spent over $4.7billion on direct-to-consumer advertising in 20084 (a 260% increase from 19976), and there’s a reason why the majority of this goes on broadcast rather than print media. This is not down to bad business sense or the sudden development of a Mother Teresa persona. It comes down to dimes and dollars, and the more people they get taking their medicines, the more money they make.
A survey found that 71% of doctors believe that direct-to-consumer advertising pressures them into prescribing drugs that they normally would not7.
Weight loss in a pill
Let’s take a prime example of how the pharmaceutical industry plays on people’s emotions, and offers short-sighted pharmaceutical answers, by looking at weight loss pills. As we exposed in Part III, dieting just doesn’t work long-term. Dispirited by past failures and desperate for an answer (this is where big pharma’s marketing strategy really pays off), we discover there’s a prescription pill that will do the job. It has been approved by the drug agencies, and prescribed by a doctor, so surely it has to be effective and safe? Well, not exactly.
Until recently, there were three main weight-loss drugs available to physicians: Acomplia® (rimonabant), Reductil® (sibutramine) and Xenical® (orlistat). Acomplia and Reductil were similar. Acting on the brain to increase satiety, they made it easier to implement a low-calorie diet, meaning patients ate less. It seems these drugs had the advantage of counteracting the adaptive thermogenesis effect seen with weight-loss diets alone, as the initial weight loss in the first six to 12 months was pretty much maintained at two years. How cool is that? Just take the pill, get back on to your favourite diet, and shedding those extra kilos is easy. Except there’s one tiny hitch.
Rimonabant caused ‘serious neuropsychiatric effects’, with ‘depressed mood disorders and anxiety’ reported, along with ‘increased risk of suicide during treatment’8,9. Oh yeah, and rimonabant (unlike old-fashioned exercise) produced no improvement in cardiovascular outcome9. Rimonabant was withdrawn in November 2008, after spending two and half years on the European market. (Credit where credit is due, we must congratulate the FDA at least for not approving rimonabant for the US market in the first place.)
It wasn’t long (January 2010) before sibutramine was withdrawn from the European market too, this time for actually increasing cardiovascular disease (so much for the heart-healthy benefits of weight loss). In certain patients, it caused blood-pressure spikes as high as 20mmHg and heart-rate increases of 20bpm, resulting in 16% higher fatal or non-fatal cardiovascular complications (heart attacks and strokes)10. The credit the FDA gained for not approving rimonabant was negated, as they sat back for another ten months before requesting a ‘voluntary’ withdrawal from the manufacturer. But hey, let’s not fret too much; after all, it had only been on the market for almost 13 years, with millions of prescriptions written by US physicians.
So now there is just one approved weight-loss drug on the market, but it’s really nothing to boast about. Endorsed by health authorities for the obese or high-risk overweight, and touted as a long-term weight-loss solution, Xenical® (orlistat) is nothing more than the ultimate fad diet in pill form. It works by inhibiting the enzymes in the gut that break down fat, meaning that 30% of the fat eaten doesn’t get absorbed.
A four-year trial of Xenical® with a low-calorie diet showed a weight loss of 5.8kg in patients who were obese11. On average, that is just shy of a 1.5kg weight loss per year. Okay, so it’s not amazing, but maintain that for ten years and you’ve lost 15kg. But wait, a low-calorie diet (800kcals per day) with the added effect of inhibiting fat absorption – that’s just a double whammy of reducing calories. The problem is, this drug doesn’t counteract the effects of adaptive thermogenesis like rimonabant and sibutramine. Let’s take a step back and have another look at this study. In the first year, patients lost a truly impressive 10.6kg, but from years two to four they gained 4.8kg. The fact that they ‘only’ had a 45% weight regain was most likely due to the addition of 10km walking each week11.
In 2007, Orlistat got approved for over-the-counter sale in the USA, as the brand Alli® (half the dose of the prescription form), and was then approved in Europe in 2009. It is targeted at the overweight and obese masses (BMI >28) and promised ‘for every two pounds you lose Alli® will help you lose one more’. It might sound good, but we’re just back with the same old problems that beset fad diets. But this time, it just creates an even bigger calorie deficit and from one year onwards, predictably enough, the weight starts going back on.
Oh, and did we forget to mention the side effects? Excuse our oversight. Take a guess at what happens to all the malabsorbed fat? Common side effects include ‘oily spotting, flatus with discharge, faecal urgency, fatty oily stool, oily evacuation, flatulence and soft stools, abdominal pain, faecal incontinence, liquid stools and increased defecation’12. Enough said. The gut upset can be so bad that it’s thought to cause anxiety in up to 10% of people12. On top of that, absorption of the fat-soluble vitamins (A, D, E and K) might be impaired, and so too the healthful omega-3 fats, already in woefully short supply in our modern diets. Now we’re on a roll, I guess we should quickly mention the new warning added by the FDA in 2010, that in rare cases it may cause ‘severe liver injury’13.
Perhaps of most concern when it comes to the whole obesity drug fiasco, and a prime example of how overreliant we are on drugs, is the following quote taken from a 2010 article in the prestigious British Medical Journal (BMJ), written by Garth Williams, a UK Professor of Medicine:
Perhaps the time has come for us to face reality and admit defeat. Like climate change, nuclear waste, and other side effects of our current version of civilization, we shall just have to learn to live with obesity and its hazards10.
With all due respect to the esteemed professor, perhaps the time has come for us to realize that there is no quick fix and no magic bullets, and that our trust and overreliance on medications is severely and inappropriately misplaced.
Prevention in a pill
Pushing obesity to one side, we could take just about any of our major chronic diseases, say, heart disease, cancer or osteoporosis. While the diagnosis might come as a terrible shock, they didn’t just happen overnight. Rather, the condition would have been brewing for years, probably decades, before finally manifesting as a heart attack, a tumour or a fracture. When the diagnosis is finally made, what we’re faced with is the end product of years of progressive dysfunction in the complex machinery of the human body. When things have gone this far, how realistic is it to think that a pill will solve all of it? More often than not, the best the drugs can do is help manage the condition, buy us some time, or stop it from getting any worse. Rarely do they proffer a cure. It might not be sexy, but it’s for this very reason prevention makes for such a powerful medicine.
This leads us on to the ‘ingenious’ idea of the polypill. In 2003, Professors Wald and Law, of London’s Wolfson Institute of Preventive Medicine, suggested a blanket treatment for everyone over 55 for cardiovascular disease, based on the premise that the overwhelming majority of cardiovascular disease occurs in this age group14. An ‘all-in-one’, the polypill would be a low-dose cocktail of five different cardiovascular drugs (three for blood pressure, a statin and aspirin) and a vitamin (folic acid). The concoction was selected to modify four different cardiovascular risk factors simultaneously – blood pressure, cholesterol, blood clotting and homocysteine. It didn’t matter whether you had a problem with any of these risks factors or not, this would be preventive medicine for the masses. The authors estimated that cardiovascular disease could be cut by more than 80% (although 8–15% of the population would likely suffer side effects).
In December 2004, a series of US experts gathered in Atlanta to discuss the merits of the polypill15. The recommendation was that clinical trials begin in the USA and Europe without further ado. The committee expressed ‘excitement’ at this concept of ‘delivering health care in a wholly new way’, especially as ‘changing lifestyle is hard to achieve in current social and political environments’.
So that’s it then? Changing lifestyles is all a bit too much like hard work. Let’s just medicate great swathes of society instead. Once the polypill ‘cures’ cardiovascular disease, we’ll have cancer as the new number-one killer in the world. Maybe there could be a low-dose chemotherapy polypill for that, too? Then there’s diabetes, osteoporosis, Alzheimer’s and arthritis, all of which urgently need to be tackled. If we could just squeeze enough drugs into a big enough pill we could stop the lot of them.
Is this really what preventive medicine has come to? A pharmaceutical pick ‘n’ mix? Maybe we’re just naïve, but we have a very different vision of preventive medicine.
We can’t help but wonder what effects a polypill that proffers ‘immunity’ to heart disease will have on people’s behaviour? Let’s face it, if we were exempt from speeding tickets when driving, there are quite a few people who would probably drive faster. Yet the accident risk is still there, and would only increase. Is the concept of the polypill really so different to that? Who cares about quitting smoking, cutting down on alcohol, starting some exercise or eating less junk if you’ve got a polypill to protect you? You might not get heart disease, which is great; instead you’ll be hurtling for a head-on collision with any number of other chronic disease states instead.
Professors Wald and Law may have concluded that ‘No other preventive method would have so great an impact on public health in the Western world’, but we’ve got a different take on health. We already have just about the most amazing ‘polypill’ you could imagine. It helps prevent all prevalent Western diseases, and its key ingredients are a good diet and exercise.
Prevention on a plate
Some 18 months after Wald and Law proposed the polypill, the British Medical Journal published ‘The Polymeal’, a more natural and safer diet-based strategy16. The idea was to construct a diet that included a ‘recipe’ of cardio-protective foods that would reduce cardiovascular disease by more than 75% (putting it effectively on a par with the polypill). It sounds tasty too, consisting of dark chocolate (100g per day), fruit and vegetables (400g per day), wine (150ml per day), fish (114g four times per week), garlic (2.7g per day) and almonds (68g per day). The authors quip that ‘redundant cardiologists could be retrained as Polymeal chefs and wine advisers’, and while that may be a bit of light-hearted banter, there is an important underlying principle here. With a bit of ingenuity, the benefits of a wonder cure for cardiovascular disease could just as easily be replicated through food as by pharmaceuticals. As the authors so aptly put it, ‘finding happiness in a frugal, active lifestyle can spare us a future of pills and hypochondria’.
Despite all of this, plans for the polypill push ahead. The results of the first world study of a polypill were published early in 2011117. The pill, reduced to four drugs (aspirin for platelets, lisinopril and hydrochlorothiazide for blood pressure, and simvastatin for cholesterol), was found to reduce blood pressure by 9.9/5.3mm Hg and LDL cholesterol by 20%. With the added anti-platelet effects of aspirin, this is expected to reduce the risk of coronary heart disease and stroke by 60% and 62% respectively. However, there was a big trade-off. The trial only lasted 12 weeks yet one in six patients experienced side effects, and one in 20 people had to stop the drug as the adverse events were intolerable.
It’s not as though we don’t have well-researched dietary alternatives either. In patients with a similar baseline blood pressure, a well-conducted RCT (the DASH study) showed that a diet high in fruit, vegetables, poultry, fish, wholegrains, nuts and low-fat dairy products – and low in red meat, sugar, saturated and total fat intake, and limited in salt – reduced blood pressure by a similar extent (8.9/4.5mm Hg)18. When cholesterol levels were measured it was found that LDL cholesterol levels dropped 9%19.
Of course, as good as the DASH diet is, you needn’t stop there. As you’re about to see in the next chapter, greater cardio-protection could be achieved by adding plant phytostanols (2g per day) to reduce LDL levels by 10%, and eating oily fish, which proffer anti-platelet effects as well as lowering triglycerides, another important cardiovascular risk factor. Add to this the benefits of other healthy lifestyle factors – such as exercise, weight loss and smoking cessation – and it is clear to see how a comprehensive dietary and lifestyle strategy trumps the polypill big time.
Unlike the drugs, the side effects of dietary changes are all positive. Adhering closely to the DASH diet is associated with a 20% lower risk of colorectal cancer20, and a 70% lower risk of type 2 diabetes in Caucasians21, and as more research is published, we are expecting benefits for osteoporosis prevention to be revealed too22.
THE PARTING SHOT
The distinction between preventive medicine and medicating society is becoming increasingly blurred. In a society defined by convenience, maybe just popping a pill is the fitting answer, irrespective of the consequences. There’s a multi-billion dollar drug industry that’d be very happy with that result. But is it really such an attractive solution? Or, as we fear, is it set to unhinge the health of our society?
Since time immemorial, we’ve had to rely on the complex array of natural compounds found in the food we eat for real health. This won’t be changing anytime soon. These, not the drugs, should be pushed to the forefront of a truly preventive system of healthcare.
SUMMARY AND RECOMMENDATIONS
· Prescription drugs have their place, but think of them more as a last resort than a first port of call.
· This is especially the case when it comes to health problems that are related to diet and lifestyle – addressing the true cause is better than popping a pill.
· Changing eating habits and behaviour is tough, but you get all the rewards without the common side effects of drugs.
· When it comes to prevention, the natural compounds found in food can take on the might of the prescription agents and usually come out on top with aplomb.