Medicines and Healthcare products Regulatory Agency

In April 2005 the House of Commons health select committee in its report on the influence of the pharmaceutical industry found that the agency was complacent. The government then  abolished the agency's two key advisory bodies—the Medicines Commission and the Committee on the Safety of Medicines. These are to be replaced by the Commission on Human Medicines (CHM). This will advise licensing of drugs, have overall responsibility for drug safety issues, advise on the appointment of members of the other professional bodies serving the MHRA and hear appeals from drug companies when a licence application has been rejected.

The new commission will be advised by three standing committees and around 15 expert advisory groups (EAGs). The standing committees will deal with biologicals and vaccines, pharmacovigilance, and pharmacy and standards. The expert advisory groups will probably have a dozen or so members, including four or five specialists. The job of these expert advisory groups will be to scrutinise the licence application and ultimately recommend to the CHM whether a licence should be awarded.

The MHRA will also have three statutory committees and a new advisory committee on herbal medicines. Like the CHM these will advise ministers directly. Chairs of the standing committees and expert advisory groups will not be permitted to have personal interests in the pharmaceutical industry.

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Deaths and obesity

Being obese or underweight is associated with increased mortality, but the number of deaths associated with obesity appears to be decreasing over time, possibly due to improved management of other cardiovascular risk factors, according to survey data from the United States.

The researchers looked at the relative risks of mortality associated with different levels of body mass index (BMI) from a nationally representative National Health and Nutrition Examination Survey and a series of previous studies.  The results showed that obesity (BMI>30) was associated with 112,000 excess deaths in the year 2000 and underweight (BMI<18.5) with 33,746 excess deaths compared with people of normal weight (BMI<25). However people being overweight (BMI 25-30) was not associated with excess mortality.

Looking at trends over time, the relative risks of mortality associated with obesity were lower in more recent data. The lead author of the study, said, "The differences between earlier and the later surveys suggest that the association of obesity with total mortality may have decreased over time,  perhaps because of improvements in public health or medical care for obesity related conditions."

A second analysis of the data looking at 40 year trends in cardiovascular disease risk factors by BMI categories, showed that the prevalence of high cholesterol levels (>240 mg/dl), hypertension (>140/90 mm Hg), and current smoking had declined, particularly in people who were overweight or obese. Diabetes was the only risk factor that had remained stable in prevalence over the 40 years.

Compared with obese people in the first data from 1960-2, the obese group in 1999-2000 had a 21% lower prevalence of high cholesterol level, an 18% lower prevalence of high blood pressure, and a 12% lower rate of smoking. The prevalence of high cholesterol had fallen more in people who were obese and overweight than in those who were normal weight or below. Changes in risk factors were accompanied by increases in lipid lowering and antihypertensive drug use, particularly in obese people.

Total diabetes prevalence was stable within different BMI groups over time, with a non-significant increase between 1976-80 and 1999-2000. However, this was accompanied by a 55% increase in total diabetes among the overall population (all BMI groups combined).

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Pain in the knee

Knee pain is common, especially in older people. Much is mild, and has little impact on how those with knee pain get on with their lives. As with most conditions, there is a gradation in severity, so that some have more pain, or are disabled, some should be getting specialist advice, and some of those perhaps need a joint replacement. Knowing the numbers would be helpful in planning services, and a Manchester study, quoted by Bandolier provides them.

The first questionnaire asked about musculoskeletal symptoms, pain in various sites for more than one week in the past month, demographics, and employment status. A second questionnaire was sent to those reporting knee pain. This asked about severity, and consultations for knee pain. The prevalence of knee pain was similar in adult men and women at about 19%, but was higher than this in older persons.

Responses to the second questionnaire showed the same gradation with age. Overall, 12% of adults had knee pain that was moderate or severe, 9% had knee pain of more than five years, and 3.4% had moderate or severe pain and disability. Factors associated with increased knee pain were higher BMI, social deprivation and South Asian ethnicity. A significant proportion of knee pain could be ascribed to being overweight or obese. Of all knee pain, this was 21%, and up to 37% for moderate or severe pain with disability. Most of this came from being overweight.

From an analysis of patients seen by a consultant rheumatologist it was estimated that 4.5% of the adult population needed specialist treatment, most (2.8%) for orthopaedics. The unmet need was about twice the level of need currently being met. In a practice population of 10,000 adults, this unmet need amounts to 320 patients.

Bandolier 103 reported a survey showing a large unmet need for hip replacements, and the present survey shows another large unmet need for knee pain, probably including replacement.

But it also demonstrates that there is an opportunity to reduce the burden of knee pain, by showing the link with being overweight.

Reducing excess weight in the community will have many paybacks, not just heart disease and cancer, but also in a reduced requirement for specialist services for musculoskeletal conditions.

Web: Bandolier

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