Health: The No-Man's-Land Between Physics and Biology.

Health as a positive attribute is poorly understood because understanding requires concepts from physics, of which physicians and other life scientists have a very poor grasp. This paper reviews the physics that bears on biology, in particular complex quaternions and scalar fields, relates these to the morphogenetic fields proposed by biologists, and defines health as an attribute of living action within these fields. The distinction of quality, as juxtaposed with quantity, proves essential. Its basic properties are set out, but a science and mathematics of quality are awaited. The implications of this model are discussed, particularly as proper health enhancement could set a natural limit to demand for, and therefore the cost of, medical services.

Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review.

BACKGROUND: Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing. METHODS AND FINDINGS: We searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise). Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians' prescribing. We searched Medline (1966 to February 2008), International Pharmaceutical Abstracts (1970 to February 2008), Embase (1997 to February 2008), Current Contents (2001 to 2008), and Central (The Cochrane Library Issue 3, 2007) using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians' prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies) and other sources (138 studies). Articles were then excluded because they did not fulfil inclusion criteria (179) or quality appraisal criteria (18), leaving 58 included studies with 87 distinct analyses. Data were extracted independently by two authors and a narrative synthesis performed following the MOOSE guidelines. Of the set of studies examining prescribing quality outcomes, five found associations between exposure to pharmaceutical company information and lower quality prescribing, four did not detect an association, and one found associations with lower and higher quality prescribing. 38 included studies found associations between exposure and higher frequency of prescribing and 13 did not detect an association. Five included studies found evidence for association with higher costs, four found no association, and one found an association with lower costs. The narrative synthesis finding of variable results was supported by a meta-analysis of studies of prescribing frequency that found significant heterogeneity. The observational nature of most included studies is the main limitation of this review. CONCLUSIONS: With rare exceptions, studies of exposure to information provided directly by pharmaceutical companies have found associations with higher prescribing frequency, higher costs, or lower prescribing quality or have not found significant associations. We did not find evidence of net improvements in prescribing, but the available literature does not exclude the possibility that prescribing may sometimes be improved. Still, we recommend that practitioners follow the precautionary principle and thus avoid exposure to information from pharmaceutical companies. Please see later in the article for the Editors' Summary.

Do advertisements for antihypertensive drugs in Australia promote quality prescribing? A cross-sectional study.

BACKGROUND: Antihypertensive medications are widely prescribed by doctors and heavily promoted by the pharmaceutical industry. Despite strong evidence of the effectiveness and cost-effectiveness of thiazide diuretics, trends in both promotion and prescription of antihypertensive drugs favour newer, less cost-effective agents. Observational evidence shows correlations between exposure to pharmaceutical promotion and less ideal prescribing. Our study therefore aimed to determine whether print advertisements for antihypertensive medications promote quality prescribing in hypertension. METHODS: We performed a cross-sectional study of 113 advertisements for antihypertensive drugs from 4 general practice-oriented Australian medical publications in 2004. Advertisements were evaluated using a quality checklist based on a review of hypertension management guidelines. Main outcome measures included: frequency with which antihypertensive classes were advertised, promotion of thiazide class drugs as first line agents, use of statistical claims in advertisements, mention of harms and prices in the advertisements, promotion of assessment and treatment of cardiovascular risk, promotion of lifestyle modification, and targeting of particular patient subgroups. RESULTS: Thiazides were the most frequently advertised drug class (48.7% of advertisements), but were largely promoted in combination preparations. The only thiazide advertised as a single agent was the most expensive, indapamide. No advertisement specifically promoted any thiazide as a better first-line drug. Statistics in the advertisements tended to be expressed in relative rather than absolute terms. Drug costs were often reported, but without cost comparisons between drugs. Adverse effects were usually reported but largely confined to the advertisements' small print. Other than mentioning drug interactions with alcohol and salt, no advertisements promoted lifestyle modification. Few advertisements (2.7%) promoted the assessment of cardiovascular risk. CONCLUSION: Print advertisements for antihypertensive medications in Australia provide some, but not all, of the key messages required for guideline-concordant care. These results have implications for the regulation of drug advertising and the continuing education of doctors.

Do advertisements in clinical software influence prescribing?

Pharmaceutical companies must believe there are benefits from advertising, but just what these benefits are, and how they are measured, is not clear.

Is Australia's national medicines policy failing? The case of COX-2 inhibitors.

Australia has a National Medicines Policy with aims that include quality use of medicines, but policy stakeholders failed to protect Australia from the COX-2 (cyclo-oxygenase-2) inhibitor disaster. Drug regulators did not warn prescribers appropriately about potential cardiovascular risks. The Pharmaceutical Benefits Scheme did not limit unjustified drug expenditures on COX-2 inhibitors. Drug companies ran intense and misleading promotional campaigns on COX-2 inhibitors without adequate controls. Independent drug information was insufficient to counter the effects of the millions of dollars spent on advertising. Core elements of the National Medicines Policy--in particular the drug approval process, the post-marketing surveillance system, the control of drug promotion, and the quality of independent drug information--require major reappraisal if we want to avoid similar disasters in the future.

General practitioners and pharmaceutical sales representatives: quality improvement research.

BACKGROUND AND OBJECTIVE: Interaction between pharmaceutical sales representatives (PSRs) and general practitioners (GPs) may have an adverse impact on GP prescribing and therefore may be ethically questionable. This study aimed to evaluate the interactions between PSRs and GPs in an Australian general practice, and develop and evaluate a policy to guide the interaction. METHODS: Doctors' prescribing, diaries, practice promotional material and samples were audited and a staff survey undertaken. After receiving feedback, the staff voted on practice policy options. The resulting policy was evaluated 3 and 9 months. RESULTS: Prior to the intervention, GPs spent on average 40 min/doctor/month with PSRs. There were 239 items of promotional material in the practice and 4660 tablets in the sample cupboard. These were reduced by 32% and 59%, respectively, at 3 months after policy adoption and the reduction was sustained at 9 months. Vioxx was the most common drug name in promotional material. Staff adopted a policy of reduced access to PSRs including: reception staff not to make appointments for PSRs or accept promotional material; PSRs cannot access sample cupboards; GPs wishing to see PSRs may do so outside consulting hours. At 3 and 9 months, most staff were satisfied with the changes. Promotional items/room were not significantly reduced at 3 months (-4.0 items/room ; 95% CI -6.61 to -1.39; p = 0.066) or 9 months (-2.63 items/room; 95% CI -5.86 to 0.60; p = 0.24). Generic prescribing significantly increased at 3 months (OR 2.28, 95% CI 1.31 to 3.86; p = 0.0027) and 9 months (OR 2.07, 95% CI 1.13 to 3.82; p = 0.016). CONCLUSION: There was a marked reduction in interactions with PSRs with majority staff satisfaction and improved prescribing practices. The new policy will form part of the practice's orientation package. Reception staff give PSRs a letter explaining the policy. It is hoped that the extra 40 min/doctor of consulting time translates into more time with patients and time to evaluate more independent sources of drug information.

Attendance of paediatricians at elective Caesarean sections performed under regional anaesthesia: is it warranted?

AIM: Whether or not a paediatric registrar or consultant paediatrician trained in advanced neonatal resuscitation is needed at elective Caesarean section (CS) deliveries remains controversial. The objective of this study was to provide recent population-based data comparing the need for resuscitation of babies born at >or=37 weeks gestation by elective CS under regional anaesthesia with those born by spontaneous, unassisted vertex vaginal delivery. METHODS: We performed a population-based cohort study in Tasmania using data collected between January 1998 and December 2003 inclusive. Data on all singleton births>or=37 weeks gestation was analysed from the Tasmanian Obstetric and Neonatal Audit database to determine the number and type of resuscitations, and the number of low 1-min Apgar scores for each mode of delivery. RESULTS: There were 31 820 singleton deliveries born at >or=37 weeks gestation over the 6-year period. Of these 21 733 (68.3%) were spontaneous unassisted vertex vaginal deliveries and 2918 (9.2%) were elective CSs performed under regional anaesthesia (2620 spinal and 298 epidural). The incidence of a 1-min Apgar score of <4 and a 1-min Apgar score of >or=4 and <7 for elective sections under spinal was significantly lower when compared with unassisted, spontaneous, vertex vaginal delivery at 0.57% and 11.8% respectively. The relative risks when compared with unassisted, spontaneous, vertex vaginal delivery were 0.36 (95% confidence interval (CI) 0.21-0.60, P<0.05) and 0.73 (95% CI 0.65-0.81, P<0.05), respectively. There was a small but statistically significant difference between unassisted, spontaneous, vertex vaginal delivery and elective CSs performed under regional anaesthesia in the requirement for resuscitation in the form of bag and mask ventilation. The relative risk for the need for bag and mask ventilation was 1.33 (95% CI 1.11-1.58, P<0.05) for spinal anaesthesia and 1.99 (95% CI 1.33-2.96, P<0.05) for epidural anaesthesia. There was no difference in the need for bag and mask ventilation or low 1-min Apgar scores between non-cephalic and cephalic presentation at elective CS under regional anaesthesia. CONCLUSION: Elective CSs performed under regional anaesthesia are low-risk deliveries. The slight increased requirement for bag and mask ventilation is not practically significant. Such deliveries do not require the routine attendance of experienced paediatric medical staff.

What are the public health effects of direct-to-consumer drug advertising?

BACKGROUND TO THE DEBATE: Only two industrialized countries, the United States and New Zealand, allow direct-to-consumer advertising (DTCA) of prescription medicines, although New Zealand is planning a ban. The challenge for these governments is ensuring that DTCA is more beneficial than harmful. Proponents of DTCA argue that it helps to inform the public about available treatments and stimulates appropriate use of drugs for high-priority illnesses (such as statin use in people with ischemic heart disease). Critics argue that the information in the adverts is often biased and misleading, and that DTCA raises prescribing costs without net evidence of health benefits.

Banning all drug promotion is the best option pending major reforms.

Drug promotion should be evaluated according to its impact on health, access to information, informed consent, and wealth. Drug promotion currently does more harm than good to each of these objectives because it is usually misleading. This is a systemic problem. Whilst improved regulation and education will address it to some degree, major reforms to payment systems for drug companies and doctors are also required. Until all these systemic reforms can be put in place, the best policy option is to ban the promotion of drugs to doctors and the public. Consequently, pending major reforms, it is appropriate for governments to restrict drug promotion as much as is politically achievable.