[e-drug] Contents of Prescrire International, February 2008 Volume 17 N° 93

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E-DRUG: Contents of Prescrire International, February 2008 Volume 17 N° 93
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Prescrire International is the English language edition of the reference French journal la revue Prescrire. It contains comparative evaluation of new drug interventions, reviews of adverse effects, and papers on drug policy issues.

Prescrire International is totally funded by subscribers, with no support from pharmaceutical industry or government. It is published six times a year and health professionals in low income countries can also benefit from the journal thanks to Solidarity Subscription Rates. Drug companies are excluded from applying to Solidarity Rates.

Contents of Prescrire International,
February 2008 Volume 17 N° 93

Editorial

. Experts and conflicts of interest
EMEA should not call on 'conflicted' experts

New Products

. Ranibizumab (macular degeneration)
Second-line use due to risks

. Erlotinib (metastatic cancer of the pancreas)
Palliative care is still the best option

. Natalizumab (multiple sclerosis)
Risky market approval

. Ibandronic acid IV (osteoporosis)
Unconvincing evidence

. Ibandronic acid tablets (osteoporosis)
1 tablet a month but risk of a flu-like syndrome

. Sitagliptin (type 2 diabetes)
Limited efficacy, too many unknown risks

. Methotrexate (idiopathic juvenile artritis)
The standard immunosuppressant

. Common stems - INNs
-gliptin and -tinib

. Telbivudine (chronic hepatitis B)
Similar to lamivudine

Shortcuts

. Mitoxantrone - Cetuximab
Adverse effects

. Hepatitis B vaccines (continued)
. Haemorrhage due to Ginkgo biloba
. Fluoroquinolones: psychiatric adverse effects
. Inhaled and nasal steroids: mental disorders
. Liver damage with the amoxicillin-clavulanate combination
. Cholinesterase inhibitors: numerous and serious interactions
. Nimesulide and hepatitis
. Omalizumab: anaphylactic shock
. Antidepressants: suicide among young adults
. Varenicline: myocardial infarction
. Efalizumab: inflammatory neuropathies
. Glitazones: fractures

Reviews

. Mammographic screening for breast cancer
Few new data
- Prescrire's advice : Mammographic screening: towards an informed choice for women

. Seasonal allergic rhinitis
Limited effectiveness of treatments
- Prescrire's advice : Drug therapy for seasonal allergic rhinitis

. Oral mucositis due to cancer treatments
Orodental hygiene and ice cubes
- Prescrire's advice : Oral mucositis and cancer therapy

Minireview

. Lymphatic filariasis

Outlook
Editorial
. Breast cancer screening : honest information please

Medicines in Europe
. Application of the European regulation on paediatric drugs : remain vigilant !

Influence
. Compliance programmes : not to be confused with risk management plans

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E-DRUG: Workshop in API and dosage form production March 18-20
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Dear E-Druggers,

PLEASE RESPOND TO THIS MESSAGE AS QUICKLY AS POSSIBLE IN ORDER TO SECURE POTENTIAL SUPPORT FOR YOUR ATTENDANCE AND TO ENSURE TIME FOR PROCESSING A VISA IF NEEDED

This message is to invite attendance at a Workshop in New Product Introduction and Green Chemical (GC) Manufacturing to be held in Abuja, Nigeria, the week of March 17 - 21, 2008. Attendance is free and limited funding is available to pay for expenses of attendees. The intended audience is companies and individuals who are practicing or actively planning cGMP production of Active Pharmaceutical Ingredients or finished dosage forms in Africa.

The National Institute of Pharmaceutical R&D, Nigeria; Howard University of Washington, DC, USA, and the US National Science Foundation are providing support for this workshop. The intended outcomes include an increased awareness of (a) API and finished dose form manufacturing to meet cGMP requirements; (b) Regulatory requirements for drug approvals by Stringent Regulatory Authorities (SRAs); (c) eligibility for bidding on tender offers and demand for essential medicines by International Donor Agencies; and (d) BENIGN, GREEN manufacturing to ensure that production does not create long-term Environmental, Health and Safety (EHS) issues..

Several world' experts will be giving presentations at the Workshop including Professor Stephen Byrn of Purdue University; Professor Robin Rodgers of the University of Alabama GC Manufacturing Institute and University College Dublin (joint); Dr. Eloan dos Santos Pinheiro, formerly of WHO and FIOCRUZ, Brasil; Dr. Uford S. Inyang, the Director-General and CEO of NIPRD; and Professor Joseph Fortunak of Howard University. Presentations from the Clinton HIV/AIDS Initiative and multiple companies practicing production in Africa are also on the agenda.

RATIONALE:
International Donor Agencies and national governments are beginning to recognize the need to produce APIs and finished dose forms for essential medicines in Africa to promote sustainability and national independence. Quality, price and long-term viability are key ingredients for the production of essential medicines. India and China have built industries upon supplying medicines for the "rest of the world." And yet, in doing so these countries have imported Environmental, Health and Safety problems that counterbalance the economic and health benefits that national pharmaceutical production has conferred.

The production of quality pharmaceuticals in Africa is not widely practiced. A number of African companies produce finished dosage forms under local cGMP. It is rate, however, that companies in Africa meet eligibility requirements (primarily WHO PQ or US FDA) to bid on tender offers from International Donor Agencies. This is largely not a matter of lacking knowledge or skills. The biggest gaps to be overcome are a familiarity with the overall process of becoming cGMP compliant, business planning, capital investment and adequate training for production personnel. THIS WORKSHOP IS INTENDED TO HELP COMPANIES AND INDIVIDUALS ADDRESS THESE ISSUES. The Workshop organizers frankly believe, from international experience, that Africa has the opportunity to build manufacturing "from the ground up" that (a) is sustainable for long-term production, (b) intelligently avoids the EHS liabilities that could not easily be anticipated in India and China and (c) is cost-competitive for the production of high-quality essential medicines.

WE LOOK FORWARD TO RECEIVING EXPRESSIONS OF INTEREST FROM POTENTIAL ATTENDEES. PLEASE RESPOND TO BOTH OF THE FOLLOWING ADDRESSES TO REQUEST ATTENDANCE:

  jfortunak@comcast.net
  kunleoo@hotmail.com

Joseph M. Fortunak
Associate Professor
Chemistry and Pharmaceutical Sciences
Howard University
Washington, DC 20059 USA
+1 202 806 6880
+1 301 928 7568
jfortunak@comcast.net