PubMed · 12024869
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P David Jarry. 2002. Deception, perception, and P values.. https://pubmed.ncbi.nlm.nih.gov/12024869/
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Statins are lipid-modifying drugs which dramatically lower the total and low-density lipoprotein cholesterol levels and have been shown in large clinical trials to reduce the rate of vascular events, including heart attacks, strokes, and death. For every 1% reduction in the LDL cholesterol level, the relative risk for major coronary heart disease events is reduced by approximately 1%. Since the landmark Scandinavian Simvastatin Survival Study (4S) was published in 1994, multiple further clinical trials have reinforced the benefits of treating large numbers of patients with statins with the emphasis on achieving low LDL cholesterol levels (currently 1.6 mmol/L) for the optimal management of patients at very high risk. However PHARMAC's actions since statins were first available have significantly impaired the optimal management of New Zealand patients. A review of the methods employed during the statin era is a useful exercise in understanding how PHARMAC functions and emphasises the point that rather than achieving low-cost prices for drugs, PHARMAC simply impedes the timely delivery of modern medicines to New Zealand patients.
BACKGROUND: 99mTc-sestamibi is a useful radiopharmaceutical for myocardial perfusion imaging, parathyroid imaging and breast tumour imaging. However, the preparation is time consuming and the limit of 3 ml on the volume of liquid that can be added to the Cardiolite kit vial means that it is often difficult to draw up small doses for patient studies. AIM: To modify the method of preparation of 99mTc-sestamibi in order to reduce the preparation time and to give a preparation which is more convenient for withdrawing patient doses. METHOD: A modified kit was prepared by reconstituting a Cardiolite kit vial with 3 ml Sodium Chloride Injection (0.9%) BP, sub-dividing it into two separate nitrogen-filled vials before adding sodium pertechnetate and boiling for radiolabelling. 99mTc-sestamibi was also prepared according to the manufacturer's recommended method and diluted with sodium chloride injection after preparation. Radiochemical purity was assessed by thin-layer chromatography and high-performance liquid chromatography. RESULTS: 99mTc-sestamibi prepared according to the manufacturer's recommended method had high radiochemical purity (96.9%+/-1.1%) and retained >90% radiochemical purity over 8 h following dilution. However, 99mTc-sestamibi prepared by the modified method gave variable and inconsistent results. CONCLUSION: The modified method of preparation was not robust enough to give reproducibly high radiochemical purity. However, dilution of 99mTc-sestamibi prepared according to the manufacturer's recommended method was satisfactory. This study highlights problems with the analysis of 99mTc-sestamibi and the limitations of modifying the method of preparation.
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