Diet, Statins, Drug Marketing and Medical Practice

Partly because I can’t access an online version of a article that ran in the print version of the Financial Times, we will turn to a story that may seem tangential but in fact has something to say about economic self interest versus the common good.

From the BBC’s website, a story about how a small group went on a radical diet to improve their health:

What if humans cast aside processed foods and saturated fats in favour of the sort of diet our ape-like ancestors once ate? Nine volunteers gave it a go… and were glad they did so.
Being locked in the zoo and offered bananas to eat is the kind of extreme diet scenario to wake some of us screaming in the night. But that was how a group of volunteers opted to try to cut their blood pressure and cholesterol levels.

They set up home in a tented enclosure at Paignton Zoo, Devon, next to the ape house, in an experiment filmed for TV. The idea, says Jill Fullerton-Smith, who helped organise the trial, was that modern diets, often dominated by processed foods and saturated fats, cause costly health problems.

For example, nearly half Britain’s 117,000 annual deaths from coronary heart disease are linked to high cholesterol, according to the British Heart Foundation. And while the government urges everyone to eat five portions of fruit and veg a day, obesity is still rising.

So could an experiment on ordinary people’s lives deliver the healthy eating message?

Nine volunteers, aged 36 to 49, took on the 12-day Evo Diet, consuming up to five kilos of raw fruit and veg a day.

The regime was devised by nutritionist and registered dietician Lynne Garton and King’s College Hospital. It was based on research showing such a diet could have health benefits for cholesterol levels and blood pressure, because it is made up of the types of foods our bodies evolved to eat over thousands of years.

Ms Garton looked for inspiration to the plant-based diet of our closest relatives, the apes, and devised a three-day rotating menu of fruit, vegetables, nuts and honey. The prescribed menu was:

• safe to eat raw;
• met adult human daily nutritional requirements; and
• provided 2,300 calories – between the 2,000 recommended for women and 2,500 for men,

Volunteers could also drink water. In the second week, standard portions of cooked oily fish were introduced – a nod to a more hunter-gatherer lifestyle.

Among the volunteers was Jon Thornton, 36, a driving instructor from Sheffield, who had never eaten vegetables, from childhood upwards.

Weighing in at almost 19-stone, his typical diet read like the children’s book, Mr Strong. Breakfast was four slices of toast; at 10am a bacon sausage and egg sarnie followed; fish and chips for tea and a Chinese take-away before bed…

Despite nearly backing out at the start – the first day’s food arrived in a cool-box, was raw and he was distinctly uncomfortable with the idea of broccoli – he was converted to eating vast portions of fresh fruit and veg.

“I didn’t feel any loss of energy, I didn’t feel ill at all,” he says. “It’s not a diet you’d recommend as a diet itself, but it worked to bring my cholesterol and blood pressure down.”

With so much food bulk and plenty of calories the subjects did not go hungry – indeed most failed to finish their daily ration. And once they were over the withdrawal from caffeinated drinks and some foods, says Ms Garton, they enjoyed good energy levels and mood.

So the “moments of unhappiness and grumpiness” that the TV crew was primed to capture failed to happen.

Driving instructor Jon cut his cholesterol and his weight

Overall, the cholesterol levels dropped 23%, an amount usually achieved only through anti-cholesterol drugs statins.

The group’s average blood pressure fell from a level of 140/83 – almost hypertensive – to 122/76. Though it was not intended to be a weight loss diet, they dropped 4.4kg (9.7lbs), on average.

The regime provided an education for all, and a permanent change for some.

“The main lesson that they took away was to eat more fruit and veg,” says Ms Garton. They also cut salt intake from a group average of 12g a day, to 1g (against a guideline maximum of 6g) and reduced saturated fat – which makes cholesterol – from 13% to 5% of calories (recommended, 11%).

At the same time, they increased the soluble fibre which binds cholesterol in the gut, so that it is expelled, and increased the intake of plant sterols – which help to lower cholesterol.

For Jon, life has changed since he was “released” from the zoo. He has gained a little weight but now says he only eats when hungry and knows good food can help health and longevity. He can play football because his knees no longer hurt under the extra weight and he goes cycling.

He even managed to hold out at the most tempting time of year. “For the first time in 36 years this year I had vegetables with my Christmas dinner,” he says. “Usually, I say no to them and have a few extra roast potatoes instead.”

Now this was a small sample, but it illustrates that diet change can be as effective in lowering the risk factors associated with heart disease, namely, high blood pressure, high cholesterol, and being overweight.

The reason this little story merits comment is that most American doctors believe that their patients aren’t capable of what is called “lifestyle modification,” meaning eating better and exercising more.

What is wrong with this line of thinking? Plenty. First, low expectations are self-fulfilling (read Pygmalion in the Classroom, whose findings have been confirmed in later studies, if you beg to differ), so the very fact that doctors don’t believe their patients can behave responsibly is contributing to the problem.

Second, the fact that modern medicine is not intersted in diet as a solution to a problem largely caused by diet means that the remedies are in the hands of women’s magazines, “nutritionists,” and food companies, many of which have been labeling foods as “light,” “natural” or “healthy,” when they are in fact not all that different from regular processed fare. There is virtually no science being applied here, largely because results can’t be patented or otherwise protected.

Look at the regime used in the BBC case. It was by design extreme. Yet it worked far better on just about every axis than conventional diets: the participants had high energy levels, they felt they had enough food, they quickly came to like what they were eating, they lost weight and showed markedly better blood pressure and cholesterol readings, and many continued to adhere to the diet (admittedly less rigorously) after it was over.

Most diets, by contrast, are based on calorie restriction (note that this one wasn’t), and therefore result in subjects eating either smaller portions or less tasty versions of foods they generally eat. And most diets are ineffective because people resume their old habits and put the weight back on. Yet despite the failure of these traditional weight loss approaches, most so-called experts continue to recommend them.

Third, the use of drugs to combat what is often bad lifestyle, is costly and may not be as safe as is generally believed. To combat the three problems alleviated by the EVO diet – high cholesterol, high blood pressure, and overweight – would take three separate drugs (at least). Let’s look at just one remedy, statins, which are one of the most widely used drugs and are generally considered to be safe.

Statins are top sellers. Worldwide revenue approached $30 billion. There is some evidence to suggest that they help combat other ailments, including Alzheimers, multiple sclerosis, and diabetes. Indeed, some researchers have gone as far as suggesting that statins be put in the water supply.

However, the downside (aside from the cost) of blockbuster drugs like statins seem to be underreported. For example, the University of California, San Diego (UCSD) School of Medicine has launched a website, www.staineffects.oom, so that users can report adverse effects. Beatrice A. Golomb, M.D., Ph.D., Associate Professor of Medicine, discussed some of her findings:

The most common problems we hear reported pertain to muscle pain or weakness, fatigue, memory and cognitive problems, sleep problems, and neuropathy. Erectile dysfunction, problems with temperature regulation (feeling hot or cold, or having sweats), are among the other problems reported…

…benefit to survival with statins or other cholesterol-lowering agents has never been demonstrated in women (even those at high cardiac risk), in the older elderly, or in men at lower cardiac risk…

There are an increasing number of reports in the medical as well as lay press arguing that the statins can have serious side effects and should be dispensed more selectively. But that view, so far, has not gotten anywhere as much press as new, but largely unproven, uses.

Fourth, and most damning, it isn’t clear that lowering cholesterol levels is beneficial to health. Remember, cholesterol is a “risk factor.” That’s a polite was of saying that it is correlated with heart disease, but causality hasn’t been established. That means that both heart disease and elevated LDL levels could be the result of other, unknown, factors. (Indeed, there is increasing and robust debate on this topic, but it would take a good deal of space to do it justice).

But given the profits at stake, is it any wonder that popping pills holds sway over simply eating better?