ABSTRACT

The New England Journal of Medicine (NEJM) recently published ground-breaking Australian medical research confirming that by taking a cocktail of Glargine, Metformin, Gliclizade, Avpro and Lipitor you can lower the risk of worsening nephrology in diabetics by 21%. What they didn’t say was that this intensive drug regime had about the same effect as one less chocolate frog and one more 10 minute walk around the block every day.

INTRODUCTION

Champagne corks were popping and press releases flying down at the gorgeous King George V Institute for International Health recently with the ground-breaking announcement they’d discovered that diabetics could lower the risk of serious kidney dysfunction by 21% if they underwent an intensive drug treatment using the Servier diabetes drug Gliclazide.

And ground-breaking news it was indeed. Having secured the financial success of the project with funding from Servier and the NH&MRC, 1400 odd researchers from prestigious diabetes institutes around the world (including doctors, Fu, Lu, Wu, Zu, Ding and Honka), rounded up 11,140 subjects and divided them into two groups of equal size. One, the ‘standard group’, was provided with  ‘standard’ drug treatment and the other group, the ‘intensive’ group with Gliclazide and other drugs in higher doses.

(Note the emphasis on 'standard' drug treatment. Drug treatment is the only standard treatment of diabetes in this country.)

On the question of funding, the George was very secretive about what the project cost and in particular the funding they received from Servier. The head medical man from Servier wrote to say they 'actually don't have the information ...'  The NH&MRC did their best to follow their own money trail but came to a dead end somewhere in the bowels of the University of Sydney. They couldn't quite work out how the university had parcelled out money for cardiac and diabetes research to it's various subsidiary institutes. Presumably it doesn't matter. What's a few million between mates.

FINDINGS

Anyway, this is what the researchers found.

In the intensive group, the number whose kidney function worsened was only 4.1%.

In the standard group the number of people who suffered from worsening kidney function was only 5.2%.

To the untrained eye the difference doesn’t seem to be highly significant. It's not. But to the eager George Institute it’s a massive difference, a 21% difference, presumably enough to cause a run on Gliclazide stocks in pharmacies across the country. 

The New England Journal of Medicine picked up on this breath-taking result and published a paper prepared by the research team. 21%, that’s definitely something the rest of the world needs to know about.

The American Diabetes Association liked the idea too and reserved a spot on the podium at its San Francisco Conference (code for brown nosing, back scratching, head patting, curry favouring and drug company advertising). This is exceptionally good news for the diabetes industry

The NH&MRC, joint funders of the project were so impressed they got the press secretary of the Minister for Health to dash off a press release saying how marvelous it was.

But here’s what really happened.

There was a lot of collateral damage in this project – and this is just the 'intensive' group!

•     9.25% of people died

•     10% had heart attacks and stokes

•     5% died of heart attacks.

•     6% of people had strokes

•     22% had secondary cardiovascular events

•     54 % suffered from visual deterioration

•     16 % suffered from cognitive decline

•     44% were hospitalized.

NOW FOR THE EARTH-SHATTERING NEWS 

For those of you who missed the trick here it is in slow motion replay.

1. Divide 4.1 by 5.2. You’ll come up with the answer of 78.846.

2. Take 78.846 away from 100. You should get 21.154.

3. Round it off and add a percent sign and you get 21%.

Did you just feel the earth move?

NUMBER TO TREAT

Putting the results into perspective, what the 21% really means is that out of every 100 people, over a five year period, there is a probability that 1 less person from the ‘intensive’ group is likely to have some kind of kidney dysfunction compared with the ‘standard’ group. This figure is known in the trade as the number to treat. Keep you eye out for it in research reports. When 21% is actually 1 in a hundred over 5 years you know the 21% is bunkum.

THE SWIFTIE

If that’s success I’d hate to see failure! It’s a pharmaceutical research swiftie, beefing up the importance of the relative results, and playing down the importance of the absolute results and the number to treat. It's a junk pharmaceutical research trick, a legerdemain.

It's the same swiftie that propelled sales of cholesterol lowering and hormone replacement drugs into the stratosphere. John Abramson in his book 'Overdosed America' picked over the entrails of the AFCAPS/TexCAPS cholesterol study. Here's what he found. 'In order to prevent one death from cardiovascular disease, 100 people in this study would have to be treated with a statin drug for 25 years.'

Compared with 1000 aerabytes a week all at a heart rate greater than 120 beats per minute and a reduction in body fat to less than 20% for men and less than 30% for women the George's results are piffling. They pale into insignificance when stacked up against the results on the Biggest Loser

ANATOMY OF AUSTRALIAN MEDICAL RESEARCH

The great tragedy is that this project is representative of a lot of medical research projects being carried out around Australia. The system works like this.

A group of researchers look in the cupboard. It’s bare. They dream up a project that’s then whipped around the drug companies to see who’s interested. This is not a tough assignment when, like the George Institute, research staff are on drug company boards and receive drug company lecture fees, grants and awards.

One of the drug companies with an eye to gaining a cheap commercial advantage gives the project the nod.

(The routine also works back the other way. The drug companies dream up a marketing ploy and then call the boys in from the sheltered workshops and induce them to do a research study, the underlying effect being to increase drug sales. The boys love this one. As well as money to play games with people and numbers, they also get lecture fees to drum up sales to local GP’s who take time off from their gut-busting routines to attend silver service dinners at the Opera House.)

Then it’s off to Tullamarine or Mascot for the flight to Canberra to pass the hat around at the NH&MRC branch of Centrelink. That’s not too tough an assignment either, particularly if your staff, like those of the George Institute are on NH&MRC committees, grant review panels, interview panels, award ranking panels and clinical trial committees.

Peer review isn’t too much of a problem either. The word ‘peer’ is code for ‘mate’ or 'club member'.

Then comes the easy part, the research, followed by the hard slog of writing papers, getting suits dry-cleaned and booking airfares for overseas conferences. (The list of cities visited by George Institute staff last year reads like a Peter Stuyvesant commercial.)

Then, before you can say 'Bob's your uncle',  the cupboard is bare, begging bowls are brought out and letters to editors dashed off calling for more money for medical research.

If anything what the (inappropriately named) ADVANCE project highlights is the fact that this research methodology is perverting the course of both public and private health; where selective-evidence, pharmaceutically-based, junk medicine becomes the treatment of choice for the majority of the population and paid for by the Government. Poor function is not restored to good. People are lulled into the false sense of security that they are getting better and that they don't have to do anything to themselves.

THE OVERSIGHTS

The fitness of participants wasn’t measured, a serious oversight when aerobic fitness stands in equal stature (at least) to blood pressure and glucose in understanding the aetiology of diabetes.

There is no record of anybody becoming fitter or healthier because of the project. We do know that as a group they didn’t take the opportunity offered by the program to trim down and/or increase lean muscle mass.

There was no scientific prescription or monitoring of aerobic exercise or the development of muscle bulk, and to my knowledge no scientific measurement of body fat. Diets were not monitored.

Some of the people in the intensive group attended a clinic 30 times in the five years of the project. No one took the opportunity offered by those visits to spend an extra ten minutes checking to see whether they had developed more lean muscle tissue or were aerobically fitter. The research staff sat on their hands and watched as the health of their subjects deteriorated.

When it comes to medical and pharmaceutical research, it seems to be par for the course to ignore the pivotal role that the scientific measurement and prescription of exercise has in the treatment of metabolic dysfunctions. The AusDiab study didn’t measure how fit people were either.

When asked why this aspect of the study was ignored, a spokesperson for the George Institute said ‘you have to remember that people find it very hard to adhere to intensive lifestyle interventions. In addition, delivering and maintaining intensive lifestyle interventions is incredibly resource intensive.’

Hello! I never thought that going for walk every morning was particularly resource intensive. I’m sure former Prime Minister John Howard doesn’t think that way either.

Throughout the study no one was checking to see whether the health of the participants was getting better. Why? Because it didn’t matter. The only result that mattered was that blood glucose levels were lower when using an intensive drug regime that included Gliclazide; putting to one side the fact that increased doses of any diabetes drug may well have had the same effect.

THE MASQUERADE - quack!

If it looks like a duck, swims like a duck, flies like a duck and quacks like a duck, there's a good chance that it's a duck. This study looks like, swims like, flys like and quacks like a marketing exercise engineered by Servier, masquerading as a research project.

And once George Institute staff have done the usual rounds of the medical lecture circuit, (which they do according to one of the appendices to the study), thousands of doctors will reach for the pad and prescribe another billion dollars worth of Gliclazide. The Pharmaceutical Benefits Scheme will foot the lion’s share of the bill. Servier will put some of it aside for the next project. Presumably tongues at the George Institute will be hanging out to get the job!

THE CARDINAL SINS

The NH&MRC had a comparatively small stake in this project, but that should not have stopped it from letting the George Institute commit the cardinal medical research sins, which are

•  limiting the research to a comparison of one drug regime with another

•  not comparing like dosage with like dosage and

•  not including a comparison of the drug regime to a known, successful, non-drug

    treatment.

Excuses that it’s too hard, takes too long, costs too much won’t wash. Without this comparison the public is left with the belief that they can rely on the junk pharmaceutical option to make them better.

COLLATERAL DAMAGE

Spare a thought for the people who took part in the survey thinking it might be helpful to them. For a sizable proportion of participants their health deteriorated while they were under doctors orders in some of the most prestigious diabetes research institutes, hospitals and universities in the world.

In these studies one of the fundamental tenants is to ‘first do no harm.’ The second is to do something during the study that contributes to an improvement in the health, fitness and wellbeing of the subjects.

The George Institute failed on both accounts. What they did was nothing less than carry out a junk survey of dubious worth. It's the sort of project that could have been executed by a gaggle of undergraduate nurses.

THE GOOD NEWS

There’s good news all round. Servier's happy - gaining some cheap publicity. The George Institute's happy, having come out of the exercise with its reputation for cosying up to drug companies intact.

CONCLUSION

40 years ago people with a catalogue of metabolic dysfunctions were rolled into the Pritiken Centre in wheelchairs and after a couple of months strolled out in sandshoes as fit as trout and lean as greyhounds.

In the George Institute project, of the 44% of the subjects hobbled into hospitals, 1013 of them never returned home; just tragic, heart-rending, gut wrenching.

This was research that didn’t need to be done. A lot of this sort of research doesn’t need to be done. We know enough about diabetes to know that it is not prevented by a lack of medical research and that it is not caused by a lack of Gliclazide.

The results of this research are trivial when compared with people putting themselves on an Exercise for Dummies program.

THE PENULTIMATE WORD

The NEJM editorialist (Dr. Cefalu) gave it a shellacking, even though he published it. ‘... there should be no misunderstanding that the ADVANCE (George Institute) trial had clearly negative results.' ie, it was a waste of time.

But why would the NEJM publish it if they though it was a useless piece of research?

First, the club members who reviewed it must have thought it was spot on.

Second, the stats were blinding. You couldn't let all that crunching go to waste.

Third, editor Cefalu is one of the club members. ‘Dr. Cefalu reports serving on advisory boards and receiving lecture fees from Eli Lilly, Amylin, Pfizer, and Merck and receiving grant support from Eli Lilly, Pfizer, and Merck.’

If this research proves anything it’s that it’s time that the primary healthcare management of metabolic dysfunctions, including diabetes, was handed over to the fitness profession.

THE MORALS OF THE STORY

First, the morals of the pharmaceutical industry are not above reproach. The literature is littered with the skeletons of frauds, hoaxes and swifties all perpetuated in the name of evidence-based medicine in search of a quick buck.

Second, snake oil now comes in capsules.

Third, what with all the palm greasing, back handing, Grange Hermitage quaffing, seminar presenting and committee sitting there's a big amber light on the independence of some medical/pharmaceutical research.

Fourth, next time you're on the receiving end of ground-breaking news about a new drug treatment for one of the metabolic dysfunctions, look for the absolute results and the number to treat.

Frequently the absolute results and the number to treat are piffling compared with what you can do yourself to get your body back into exceptionally good nick.

If you don't know how to do that send me an email. I'll ask you 8 questions that will set you on the right track. If you want to know what those 8 questions are, don't unsubscribe until after you receive the next newsletter. I'll also direct you to the place where you can purchase some of my ebooks.

Regards

John Miller

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