Research scare

The report shocked many doctors on both sides of the Atlantic.

Some parts of the media used it as an example yet again of the way medical authorities were failing to protect patients from the ill-effects of new drugs, and Glaxo, the company marketing rosiglitazone, suffered a melt-down in its shares.

On the face of it, a good job was done. Millions of people taking the drug could now switch to another one that wasn't so dangerous, and Big Pharma had got yet another well-deserved kick in the teeth.

So why is it that when the story is re-examined, and found to be wanting in many details, no-one takes up the real news, which is that rosiglitazone isn't dangerous after all?

As far as I know this is the only newspaper column that has looked at the other side of the claim. In the meantime, many people who depended on rosiglitazone for their good diabetic control are going without it - and that really could be harmful.

So what are the facts? The American claim was that in an analysis of many trials of the safety of the drug, there were around 43 per cent more heart attacks in people taking the drug than in others who did not. Sounds devastating evidence, doesn't it?

Yet when the data are studied more closely, only six in every thousand people taking part in the trials actually had heart attacks.

The difference between the numbers having heart attacks on rosiglitazone and those taking control drugs or placebo (dummy tablets) was less than one in a thousand.

There was no massive epidemic of heart attacks in people taking the drug - far from it. Yet that's what the authors seemed to imply, and that's why so many people asked to come off their drug.

The problem with the American report was that the people publishing it hadn't actually done the trials themselves.

All they had done was to trawl through the world-wide literature for dozens of trials, with different designs and widely different people, added up the numbers with and without heart attacks in each trial, summed all the totals, then analysed the numbers statistically.

The flaws in such methods are huge. It is far better to look at trials in which large numbers of similar people with similar problems are enrolled with the specific intent to assess health and safety on the drug, then analyse them one by one only after the trial period is up. There are three such trials of rosiglitazone.

The first looked at 4,360 people newly diagnosed with diabetes, and followed them for up to six years. Very few of them had heart attacks, and there was no difference in the numbers of heart attacks between rosiglitazone and the other drugs with which it was compared.

The second trial, in 5,269 patients with diabetes, in which the drug was compared with a blood-pressure-reducing drug and placebo, rosiglitazone was not linked with any more heart attacks than in the people who were given placebo or the blood-pressure lowering agent alone.

The third trial started in 2000 and looked deliberately for evidence that the drug might harm the heart. Recent analysis of its safety has persuaded the independent board overseeing the trial to continue with it, because it shows no evidence of an excess of heart attacks in the rosiglitazone group.

Finally, Glaxo itself has initiated a study of 33,363 people who started on pills for diabetes, including rosiglitazone, between 2000 and 2004. So far there is absolutely no difference in heart disease rate between those taking rosiglitazone and those taking other drugs.

If you are taking Avandia, and are worried about the publicity, please stop worrying. Talk to your doctor about your fears, and be reassured. There is no need to stop taking it. It is a highly effective medicine.

If you have diabetes and wish to prevent a heart attack, then you need to keep your risk factors' under control. That means having a normal blood pressure, not smoking at all and if your cholesterol level is high, get your doctor to help you bring it down.

Avandia, if it is a risk at all, which I doubt, is far, far below them in priority.

Q Over the last two months I've lost all my body hair, but I'm embarrassed to see my doctor about it. Is this common, and what can I do about it? I'm 50 and female.

A No, it's not common. You may have a thyroid problem, but it could be a form of alopecia. You will have to bite the bullet and see your doctor. You can't treat yourself. . Depending on tests your doctor may do, you may be sent to a dermatologist or a specialist in hormones - an endocrinologist.

Q I have severe arthritis which means I have to use a Zimmer. In the last few weeks my feet and ankles have been swelling. Is this due to my arthritis, and if so why do the co-codamol tablets I'm prescribed not help?

A Swollen ankles are not a sign of arthritis, but of fluid retention, and co-codamol, which is a painkiller, won't reduce that. Fluid retention can have several causes, for which you ought to see your doctor, who will do tests to check on them. You may be given treatment to deal with the excess fluid (a diuretic), but the type of treatment depends on the cause indicated by the tests.

Q I get tingling down my right arm. I'm told I have arthritis in the neck. How are the two connected?

A The arthritis narrows the space in the spine through which the nerve to the arm has to pass, putting pressure on it. The brain feels this pressure as a tingling sensation. The treatment may involve taking the pressure of the weight of your head off your neck bones. That can be done by stretching exercises or a collar, or, if things are really bad, by surgery.

Q I'm due to have an injection into a swollen vein below my left knee. What are the possible adverse effects? We hear such a lot about leg vein thrombosis these days - could the injection cause one?

A The injection does cause the vein to close off, but the effect is localised to the superficial vein under the skin, and does not affect the deep veins underneath. You will be red and sore at the injection site for a few days, but that is a minor inconvenience, and does not lead to the deep vein thrombosis that has caused so much concern, say, among long-distance travellers.

Q I often have a pain in my left side between my hips and my ribs, that sometimes gets better when I pass wind or open my bowels. What could this pain be?

A The commonest cause of this combination of symptoms is irritable bowel, due to cramps in the lower part of the large bowel. It is a real nuisance. Other less probable causes are diverticular disease (in which there are blebs' of bowel forming pouches that contain gas) or a stone in the tube (the ureter) from the kidney to the bladder. You need to see your doctor to have the diagnosis confirmed. Until it is, you will not know how it can be treated.