n°81

February 2006

Issue Contents
Editorial

Free  On whose behalf ?

p.2
Loyalty towards patients is undermined

Marketing Authorisations

Trastuzumab (metastatic breast cancer) (new indication)

p.3-5
A hope for some women with breast cancer, more research is needed in order to answer important unresolved questions

Docetaxel (prostate cancer) (new indication)

p.6-7
The likely benefits are only modest and the adverse effects are potentially severe.

Efalizumab (plaque psoriasis) (new drug)

p.8-11
Do not use: it has not been compared with other treatments.

Liposomal cytarabine (lymphomatous meningitis) (new drug)

p.11-12
Prolongs the interval between intrathecal injections but provides no survival benefit and causes more adverse effects.

Celecoxib (prevention of colorectal cancer in familial polyposis) (new indication)

p.13-15
Efficacy is unproven and the risk of haemorrhagic and cardiovascular adverse effects is increased.

Packaging: Injectable morphine

p.16-17
Improvements have been made in France to the labelling of morphine vials for injection. But there is still no unit dose product.

Doxycycline (malaria prophylaxis)

p.17
In case of mefloquine resistance or contraindication, doxycycline is analternative to the atovaquone + proguanil combination.

Gemcitabine (metastatic breast cancer)

p.17
It is just one of many possible combinations.

Adverse Effects

Statins: beware during pregnancy

p.18-19
CNS and limb defects were reported.

Nicorandil: anal ulcerations, an additional concern

p.19
Cases of anal ulceration have also been reported, which heal very slowly (several weeks) after nicorandil withdrawal

Trastuzumab cardiotoxicity

p.19-20
FDA data: the drug can cause ventricular dysfunction and congestive heart failure

Dextropropoxyphene combinations : Swedish market withdrawal

p.20
If the French authorities are really concerned with public health, they will rapidly follow the example of the Swiss, British and Swedish authorities.

Reviews

Antiviral drugs in influenza

p.21-30
Despite the lack of convincing efficacy data on oseltamivir in preventing complications of influenza, its effect on documented infections suggests it may be useful for unvaccinated individuals who are at high risk of infection and severe complications.

Outlook

Free  Opinion leaders: expensive, but cost-effective for drug companies (p. 31)

p.31
Opinion leaders have a key role in promotional strategies, whether they recognise it or not. Students of medicine and pharmacy should be informed of this situation early in their curriculum.

Free  European Regulation on paediatric medicines: some improvements but still far from perfect

p.32-33
Incentives and rewards offered to companies fail to take into account the notion of true therapeutic advantages and R&D expenditure.

Free  The French regulatory agency: where do its true priorities lie

p.33
The Agency has reached new heights of incoherence when it comes to dextropropoxyphen.

Free  Website DIPEx.org (p. 39)

p.39
Database of Personal Experiences of Health and Illness.

Forum

Free  What matters most to the French regulatory agency: public health, or the health of drug companies ?

p.34-36
The French Agency challenges Prescrire allegations of failings.

Why does Servier refuse to inform Prescrire?

p.37
Servier challenges the accuracy of Prescrire statements on strontium, and Prescrire confirm Servier

RisperdalConstaLP: was the clinical evaluation inadequate?

p.38
Janssen-Cilag challenges Prescrire assessment of risperidone.

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