n°85

October 2006

Issue Contents
Editorial

Free  The new charlatans

p.162
From obesiologists to specialists of pseudo illnesses

Marketing Authorisations

Insulin detemir (diabetes) (new drug)

p.163-167
A second long-acting insulin analogue: many uncertainties, few advantages

Duloxetine (depression and diabetic neuropathy) (new indication)

p.168-172
Uncertain efficacy, too many adverse effects

Ropinirole (restless legs) (new indication)

p.173-176
Disproportionate adverse effects

Treprostinil (pulmonary hypertension) (new drug)

p.177-179
Just another disappointing prostacycline analogue

Interferon gamma-1b (malignant osteopetrosis) (new indication)

p.179-180
Too many unknowns

Pegfilgrastim (neutropenia)

p.181
More convenient than filgrastim, but similar (limited) efficacy

Ibuprofen (patent ductus arterious)

p.181
No better than indometacin but officially approved

Adverse Effects

Oseltamivir: cutaneous and neurological adverse effects in children

p.182-183
Disturbing reports

Thyroid extracts as slimming aids: danger!

p.183
Severe thyrotoxicosis reported in France

Injectable sustained-release risperidone: recurrence of delirium and treatment failure

p.183
Use other long-acting neuroleptics instead

Appetite suppressants and pulmonary hypertension: a long-term risk

p.183
More than 5 years

Reviews

Pharmacological prevention of migraine

p.184-188
To be considered case by case

Granulocytic growth factors and cancer-related neutropenia

p.189-191
Limited effects

PART I 1963-2005: 10 randomised trials of mammographic screening

p.192
3 trials only, totalling 130 000 women, offer strong evidence. None showed a statistically significant reduction in overall mortality or breast cancer deaths

PART II Meta-analyses of mammography screening trials: inconsistent results

p.192-193
There is no strong evidence from meta-analysis supporting the use of mammographic screening to reduce overall mortality. There is weak evidence that mammographic screening reduces breath cancer deaths in women aged 40 to 74

Screening mammography

p.192-193
Not very favourable risk-benefit balance

PART III Mammographic screening and age

p.193
Age based analysis provides no convincing data favouring screening

PART IV Also in the balance: aggressive treatments, adverse effects

p.193
Problematic historical comparisons, adverse effects of mammography, and false negatives should be kept in mind. Available practice guidelines sometimes disagree

PART V Conclusions: not very favourable risk-benefit balance

p.193
The risk-benefit balance seems unfavourable in women (general population) less than 49; inadequately established between 50 and 69; not established after 69

Patients at high cardiovascular risk: excess mortality of about 1.6% on aspirin + clopidogrel

p.194
A disturbing trial

Acute myocardial infarction: aspirin + clopidogrel reduce mortality by about 0.5%

p.194
Short-term benefits

Headache and acupuncture

p.195
Chinese acupuncture no better than sham acupuncture, but both methods seem better than doing nothing

Outlook

Free  Scientific misconduct in biomedical research

p.196
Reprehensible

Free  Clinical trials in France: too many unpublished results

p.197
A publicly accessible trial registry could help

Free  Thyroid extracts: welcome measures...at last!

p.198
French authorities

Free  Conditional marketing authorisation in the EU: an improved regulation if properly applied

p.199
No early approval for drugs that offer no advantage

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