Monday, October 31, 2011

Daily dose of statins could cut risk of breast cancer by 30%

I knew this would be an epidemiological rather than an experimental finding as soon as I saw the heading. Although they are downplayed below, very troubling side-effects are common with statins. So it is only the unusually healthy who can tolerate them. And the unusually healthy are unusually healthy in other ways too. What the finding below again shows, therefore, is that good health has some generality

A daily dose of drugs designed to lower cholesterol could also slash the risk of breast cancer recurring, say researchers.

They found that women who had developed a breast tumour were nearly 30 per cent less likely to suffer a relapse if they took a type of statin called simvastatin.

Millions take statins to combat heart disease by lowering cholesterol, but research has suggested that high cholesterol could also be a key factor in the development of breast cancer.

The latest findings raise the possibility that the pills, at around 40p a day, could be a cheap and effective way of helping to prevent breast cancer returning, if future large-scale investigations confirm the results.

A team of U.S. and Danish researchers, led by Dr Thomas Ahern from Harvard Medical School in Boston, looked at nearly 19,000 Danish women diagnosed with breast cancer between 1996 and 2003.

The women were tracked for nearly seven years to see if they suffered a recurrence. Researchers also found out whether they had taken statins and, if so, which type.

Those on simvastatin were 30 per cent less likely to see their tumour return than those who had taken no form of statin.

It belongs to a class of drugs known as lipophilic statins, which means they dissolve easily in fat.

But women who took another class, known as hydrophilic statins, saw little or no reduction in cancer risk. Hydrophilic drugs, such as pravastatin, dissolve better in water.

In a report on their findings, in the Journal of the National Cancer Institute, the researchers said the results are promising enough to warrant a large clinical trial to see if statins could be routinely used to treat breast cancer.

‘In the interim, doctors prescribing statins to breast cancer survivors should favour simvastatin over other types,’ they said.

All statins attack the enzyme that produces low density lipoproteins or ‘bad cholesterol’ which can form fatty deposits in the arteries. But they are classed as either water or fat soluble depending on how they are absorbed by the body.

Fat-soluble statins enter cell membranes more easily. Scientists think statins that are more fat soluble may for some reason have a more powerful effect in terms of keeping cancer at bay.

Simvastatin is available as a generic drug or under the brand names Ranzolont, Simvador and Zocor as tablets.

It is one of the cheapest statins and is available in low doses from pharmacies without a prescription.

The National Institute for Health and Clinical Excellence recommends doctors prescribe statins to those whose chance of having a ‘cardiovascular event’ – such as a heart attack – in the next ten years is 20 per cent or higher.

Although the drugs are effective and generally safe, they can cause side-effects ranging from mild symptoms – such as headaches, pins and needles and nausea – to a rare condition called rhabdomyolysis, where muscles become sore and inflamed.

The research is the latest in a long line of studies to suggest statins may have powerful cancer-fighting properties.

In September, research revealed that men with suspected prostate cancer who had been taking statins before they had their biopsy were nearly 10 per cent less likely to be diagnosed with a tumour and 24 per cent less likely to have an aggressive cancer.

Around 48,000 women in Britain are diagnosed with breast cancer each year, equal to more than 130 a day.


We're going to have to abolish drug licencing you know

Yes, I do mean health type drugs, not fun type ones, for the latter a system of licensing would be a tremendous step forward from the current position. But for health type drugs we really are going to have to abandon drug licensing. Or at he very least, our current system of licensing them.

The reason is that currently we've a system which, however bad it is, however many people it kills by keeping new drugs off the market through the expense of getting a license, is aimed solely and purely at mass market drugs. If, as we move to more personalised medicine, we stop having mass market drugs then we cannot have a drug licensing system which is set up only for those mass market drugs that no longer exist.
If each drug takes $1 billion to reach the market and 10 million people use it over its patent protected lifetime, then each patient contributes, on average, $100 to the development of that drug. If we keep shrinking the denominator, then the economics become more difficult. Taken to the extreme of personalized medicine, with one specific drug for each person, we cannot expect that one person to cover the $1 billion development cost. Even if the development cost drops to $1 million per new drug, the economics won't work.

I think the average development cost would need to drop to $10,000 per drug to be reasonable. To reach this price, we would need to exclude the FDA completely--allow drugs to be marketed without prior FDA approval--or allow the FDA to approve the process of drug development instead of each specific drug.

And there are drug treatments out there which are tantamount to a new drug or each person: cancer treatments that study the DNA of the cancer, the specific immune system and which then turbocharge one to attack the other as an example.

Even where we retreat from such extremes we already know that different drugs have different effects on different parts of the population even when being used to treat the same disease. Those of West African derivation can react quite differently, as a group, to a drug than those of northern European, or East African, or Australasian genetic heritage as can each group from the other. We're finding certain gene combinations which mean that certain drugs will or will not work in sub-groups of such larger collectives as well. All in all, we're finding that ever more drugs have ever smaller target populations, to say nothing of those drugs we've developing, or would like to, to treat complaints that only strike a few people.

We therefore have to reduce the cost of a license for each and every drug: which means abandoning out current methods of licensing drugs. We simply cannot continue to use methods solely appropriate for mass market drugs when we're not in fact trying to develop mass market drugs.

All of which is rather alarming really. For you could, I am sure, talk to any individual who works in or with the drug licensing authorities and easily gain agreement with the basic thesis above. But there's nothing quote so conservative as a bureaucracy when acting collectively, however reasonable or intelligent the component parts of it.


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