Call to end exclusion of elderly from drug trials

A charter against ageism in clinical trials is being launched by a group of geriatricians from Europe.

The EU funded project, called PREDICT, says treatments are less likely to be tested on older people even though the elderly take the most medication.

Trial results from younger people cannot always be extrapolated to the elderly, say the authors.

They want older people to have access to drugs which have been shown to be safe and effective for their age group.

PREDICT set out assess the extent to which the elderly were excluded from clinical trials and to come up with solutions.

They surveyed the medical literature on treatments for conditions which were common among elderly people and found clear evidence that the elderly were underrepresented.

For example, the average age of patients in clinical trials of treatments for high blood pressure is 63, although 44% of patients are over 70 when they are first diagnosed.

The researchers interviewed health professionals in nine countries and conducted more than 50 focus groups with elderly people and their carers.

They concluded that both doctors and patients felt that more elderly people should be included in trials.

"If treatments are not evaluated for elderly people it is difficult for doctors to balance the risks and benefits" said Dr Gary Mills, Director of Medical Economics and Research Centre, Sheffield, who is one of the co-ordinators of the project.

'Practical steps'

Dr Mills said people conducting trials may need to take practical steps to help the elderly participate, such as going to their house rather than expecting them to travel.

The British Geriatrics Society welcomed the project. Their spokesman Professor David Oliver said the under-representation of elderly people in clinical trials was a "serious problem".

He said it was easier for drug companies to carry out testing on younger people, but this means the trial group is "not representative" of the majority of taking medicines.

He added that drugs might be more or less effective on the elderly than younger older people, and might have different side effects.

"Doctors try to practise evidence-based medicine, but this is not possible if there are not enough elderly people in the trials."

'Ageism'

Stephen Jackson, Professor of Professor of Clinical Gerontology from King's College, London, said the reasons why not enough elderly people are included in trails go beyond practical difficulties.

"The elderly are underrepresented in clinical trials because of ageism," he said.

He pointed out that elderly people often have more than one condition and that makes it more complicated for those conducting trials to include them.

People conducting trials think it is "too much trouble" to include older people he said. This would not change without regulation, he added.

Age Concern welcomed the initiative. Andrew Harrop their Head of Policy said: "More and more people will be living longer and many with multiple long-term conditions.

"Addressing the shortfall in the numbers of older people taking part in clinical trials is crucial to ensure the well-being of a growing proportion of the population."

Overweight elderly 'live longer'

Moderately overweight elderly people may live longer than those of normal weight, an Australian study suggests.

But being very overweight or being underweight shortened lives.

The report, which was published in the Journal of the American Geriatric Society, said dieting may not be beneficial in this age group.

But the study of 9,200 over-70s also found that regardless of weight, sedentary lifestyles shortened lives, particularly for women.

The study by the University of Western Australia set out to find out what level of body mass index (BMI) was associated with the lowest risk of death in the elderly.

For younger people, there is a well established health risk from being overweight or obese.

Overweight best

The team tracked the number of deaths over 10 years among volunteers who were aged 70 - 75 at the start of the study.

It found that those with a BMI which classed them as overweight not only had the lowest overall risk of dying, they also had the lowest risk of dying from specific diseases: cardiovascular disease, cancer and chronic respiratory disease.

The overall death rate among the obese group was similar to that among those of normal weight.

But those who were very obese had a greater risk of dying during the 10 year period.

Lead researcher, Professor Leon Flicker said: "Concerns have been raised about encouraging apparently overweight older people to lose weight.

"Our study suggests that those people who survive to age 70 in reasonable health have a different set of risks and benefits associated with the amount of body fat to younger people."

The conclusion of this study, that being overweight may be less harmful for elderly people, corroborates the findings of previous research.

Staying still

Sedentary lifestyles shortened lives across all weight groups, doubling the risk of mortality for women over the period studied, and increasing it by 25% for men.

Physical exercise "really matters", said Professor Flicker.

As well as helping to build muscle mass, it has broader health benefits for elderly people, he said.

The authors believe BMI may give a poor reflection of fatty mass in elderly people.

"It may be time to review the BMI classification for older adults," says Professor Flicker.

Professor Kay-Tee Khaw from Cambridge University agreed, noting that optimal weight appears to be higher in older age groups.

"This is important since under-nutrition is an important problem in older people.

"Waist circumference, which assesses abdominal obesity, appears to be a better indicator of health consequences of obesity" she said.