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Letters to the Editor Issue 122

by Letters(more info)

listed in letters to the editor, originally published in issue 122 - April 2006

Seeking Arthritis and MS Sufferers

Kinohimitsu UK is seeking to recruit practitioners to each clinically monitor a specific group of perhaps 8-10 people suffering from Arthritis or MS over a 3-6 month period, using health detox foot pads. This would involve monitoring patient progress during the trials on a weekly basis, which would include improvement of blood cells etc. Such tests would need to be carried out by the practitioner specifically treating these patients.

Results from Kinohimitsu foot pads have indicated significant clinical improvements in many people internationally. As an incentive to practitioner sponsors, and pursuant to a positive outcome, practitioner sponsors of these trials would receive a lifetime discount on any future supplies required. Please reply to the undersigned.
Margaret Knox
Tel: 0800 781 1734
Fax: 0800 781 1735

90% Of Medicines used on New Born Babies Not Properly Tested

90% of the medicines used to treat newly born babies have not been tested to ensure their appropriateness, and 50% of all medicines given to children of all ages are similarly untested.

These figures are highlighted in a House of Lords report published today on the European Commission’s proposals for paediatric medicines.

The report by the Lords EU Sub-Committee on Social Policy and Consumer Affairs praises the Commission for attempting to set up common EU-wide procedure for testing and approving medicines for use in children and incentives to encourage manufacturers to develop or adapt medicines specifically for children.

Baroness Thomas of Walliswood, Chair of the Committee, said:

“We are pleased that the European Commission has taken the lead on this important issue. It is worrying that so many of the medicinal products used by our children have not been properly tested to ensure the appropriateness of their use.

“Children are not simply small adults and it cannot be right that 90% of the medication given to new born babies has only ever been tested on adults. This will be a concern for all parents.

“We were satisfied that the basic framework proposed by the Commission was right and gave the Government the go-ahead to accept them, which they have done. But a lot of care has to be given to the guidelines that will be needed to carry out the procedures for testing and authorising drugs to make sure that ethical considerations are fully considered and clearly explained. The Government has promised to give us progress reports on this.

“While we accept that incentives are needed to encourage pharmaceutical companies to develop drugs specifically for children. The arrangements proposed are based on a system that seems to work well in the USA and is accepted by most professionals here. We’ve recommended that they should be rigorously examined in a few years’ time to make sure they are working properly, giving drug companies fair rewards for their R&D, but ensuring that the cost to the NHS and the health services of other Member States is reasonable.”

Conclusions of the Report Include:
•    Too many children’s prescriptions and over-the-counter drugs have not been properly tested on children prior to launch;
•    Children are not simply small adults and their medication should not be treated as if they were. There is an overwhelming and urgent need to take action at a European level to promote and govern clinical trials of medicines on children;
•    Guidelines covering medical trials must take into account the vulnerability of children. They will need to consider ethical issues around consent to trials by children, the effects of different drugs on children of different ages and access to research databases;
•    Medical products should be properly labelled to indicate their suitability for Children;
•    It is impossible to judge at this stage how well the incentives designed to stimulate the development of drugs for children will work. The Government must press the Commission to carry out a full economic review of the incentive arrangements after a few years of operation.

1.    The members of the European Union Sub-Committee G (Social Policy and Consumer Affairs) who conducted the inquiry were:
Baroness Thomas of Walliswood; Baroness Howarth of Breckland; Lord Colwyn Baroness Massey of Darwin; Earl of Dundee Lord Moser; Baroness Gale Baroness Neuberger; Baroness Greengross Lord Trefgarne; Lord Harrison
2.    The report is published by The Stationary Office: Paediatric Medicines: Proposed EU Regulation, House of Lords, EU Sub-Committee on Social Policy and Consumer Affairs, 20th report of session 2005/06, HL paper 101, ISBN 010 400809 1, Price £15.50.
3.    The full report will available shortly after publication on the internet at:
4.    The Committee received evidence from a wide variety of sources including the British Medical Association, Professor Sir Cyril Chantler, Chairman of Great Ormond Street Children’s Hospital and The Royal College of Paediatrics and Child Health.
5.    The report is a response to EU Commission Proposals for a Regulation on Medicinal Products for Paediatric Use.

Further Information

Owen Williams, Press and Publicity Officer (Committees)
Tel: 020 7219 8659

Take a Second Look:  Calcium and Vitamin D Really Don’t Reduce Fractures?

The New England Journal of Medicine published new findings of the Women’s Health Initiative Study looking at Calcium and Vitamin D for hip fracture reduction.1 Headlines around the country read, Calcium
and Vitamin D Supplements Don’t Cut Fracture. But, we at the Osteoporosis Education Project ask,
“Is this true?”

Sure enough, a more careful look at the study suggests that the headlines are misleading and that Calcium and Vitamin D are indeed helpful in preventing osteoporotic fractures.

In this study 36,282 postmenopausal US women were given the daily treatment of either 1,000 mg of Calcium plus 400 IU Vitamin D or placebo (sugar pills).  After seven years there was no reported significant reduction in hip fractures in the group as a whole – thus the headline, ‘Calcium and Vitamin D Don’t Cut Fracture.’ However, when researchers looked only at women over 60 years of age (those most likely to experience a hip fracture) they found there was a 21% reduction in hip fractures. Further, when researchers looked just at the women who actually took the Calcium and Vitamin D supplements on a regular basis over the seven year study, they found a 29% decrease in hip fractures.

Thus, just the simple addition of 1,000 mg Calcium and 400 IU Vitamin D did help reduce hip fracture by almost one-third among older women.

Most important of all, however, is the issue of supplement doses.

While the dose of Calcium used in the study was appropriate (1,000 mgs), the dose of Vitamin D (400 IU) used in the study was only half of the amount known to be needed to reduce hip fractures. Several good studies in the US and Europe have recently shown that supplementation with 700 to 800 IU Vitamin D (not 400 IU as used in this study) along with Calcium reduced osteoporotic fractures by some 30 to 50 or even 60%.

So the byline of this $725 million study segment should be that an adequate amount of Calcium (1,000 mg) plus half of the Vitamin D necessary to reduce fractures was able to decrease hip fractures by 29% in those women using the supplements daily. Preventing nearly one in three hip fractures with Calcium and low dose Vitamin D is not bad. Further, we surely would have seen a much greater fracture reduction if the
appropriate amount of Vitamin D had been used in this study and had all the subjects really taken the supplemental nutrients.


1.    The Women’s Health Initiative Trial of the Effect of Calcium Plus Vitamin D Supplementation on Risk of Fractures and Colorectal Cancer. New England Journal of Medicine. 354 (7): 684-96. 2006.
Susan E Brown PhD CNS, Director
The Osteoporosis Education Project,
Tel: 001 315-432-1676;
Source: Elwood Richard


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