The genuine danger of Counterfeit Medicines
November 19th, 2008
Learn how counterfeit medicines can affect patients’ health in Europe from the EFPIA.
Archive
Archive for November, 2008
Men Ignorant About True Risk Of Fake Medicine
November 17th, 2008
New research released today (12 November) highlights the risk men are taking by purchasing counterfeit medicines. The ‘Cracking Counterfeit’ report commissioned by Pfizer reveals one in ten men interviewed - which would equate to more than 335,931 men living in major cities alone - admit to purchasing prescription only medicines without a prescription.1* ,2
Half (50%) of the men who have purchased medicine without a prescription have done so via the internet - a worrying statistic when you factor in that 90% of all medicines sold on the internet are thought to be fake.1** ,3
The reality is that counterfeit medicine can damage one’s health, and in some cases cause death. 4 Counterfeit medicine can contain high levels of toxic solvents5 for example, rat poison has been found in a counterfeit blood pressure lowering treatment, while boric acid and lead based road paint have both been found in a counterfeit medicine used to ease severe pain.5
The study also highlights the ignorance amongst men about which medicines actually require a prescription - only 40% of the men interviewed knew that erectile dysfunction medicine was in fact legally available only with a prescription.1**
The report also illustrates just how big the counterfeit medicine market is - with men potentially pouring more than £10 million into the counterfeit medicine market annually.1*, 2
The ‘Cracking Counterfeit’ report reveals:
– 68% of male respondents suspect ingredients found in counterfeit medicine to be very different from authentic medicines.1**
– 37% of men cited convenience and speed as the key reasons why they purchase medicine without prescription.1**
– The majority (60%) of the men who have bought medicine without prescription admit that if there was a possibility their medicine was counterfeit, it would have a great impact on their likelihood to purchase.1**
– Almost half (45%) of men purchasing without a prescription agreed that it was easy to get hold of.1**
Dr David Gillen, Pfizer’s Medical Director said: “Men bypassing the health system to purchase medicines is a growing problem in the UK, particularly relating to the increased availability of counterfeit medicines. These new findings show that men are not only often ignorant about what medicine actually requires a prescription but worryingly they know buying medicine from illicit sources might be harmful but convenience and anonymity often outweigh their fear levels.”
“Today, 12% of UK men like to gamble online.6 Almost the same proportion, 11%, may be literally gambling on life through purchasing potentially counterfeit medicine.1* The findings paint an interesting picture and help us to further educate the public around the risks of purchasing medicine through unregulated sources, ultimately reducing exposure to counterfeit medicine.”
Read more about the dangers men face when purchasing fake medicine.
Web 2.0
FDA - Pharmaceutical News Feed
- Debate Over GSK’s Avandia Focuses on Trial Data, Use of Meta-AnalysesThe debate over Avandia could have far-reaching consequences for other drug sponsors as the crux of the controversy focuses on clinical trial data and their interpretation in meta-analyses.
- IOM Report: Informed Consent Should Be an Ongoing Process Throughout a TrialThe “kitchen sink” approach to informed consent should give way to an ongoing process that is adjusted as necessary throughout a clinical trial, the Institute of Medicine (IOM) recommends in an interim report to the FDA.
- OIG Calls for More Oversight of Foreign Clinical TrialsMore than half of all clinical trials for FDA-regulated drugs and biologics were conducted outside the U.S. in fiscal 2008, yet the agency inspected fewer than 1 percent of foreign trial sites, a report by the HHS Office of Inspector General (OIG) concludes.
- Citing Confirmatory Trials, Panel Votes No on AvastinAn FDA advisory panel voted overwhelmingly to recommend removing an indication for Genentech’s Avastin as a first-line treatment for metastatic breast cancer (MBC).
- ACRO: Proposed HHS Rule Balances Research Access, Patient PrivacyHHS’ proposed privacy rule that loosens restrictions on clinical trials strikes an appropriate balance between a researcher’s need for access to health information and protection of a subject’s privacy, according to the Association of Clinical Research Organizations (ACRO).
- FDA Guidance Sets Endpoint for Lupus Clinical TrialsDrugmakers developing products for the treatment of systemic lupus erythematosus (SLE) should use a disease activity index such as the British Isles Lupus Assessment Group as the primary efficacy endpoint in clinical trials, a new guidance says.
- Diverse EU Insurance Regulations Cause Delays in Clinical TrialsA hodgepodge of liability insurance requirements is keeping some device sponsors from starting clinical trials on time in the EU, delaying the approval process.
- Site Contract Breaches May Invite an Inspection, Data InvalidationBreaches of a trial contract can result in an FDA inspection and invalidate the data gathered at a trial site, a former FDA official says.
- Managing Risk in Clinical Trials Best Defense Against LawsuitsOne of the rising costs sponsors face in bringing a new medical product to market stems from lawsuits involving clinical trials.
- New Guidance Details Conditions for Using Foreign Data for PMAData from foreign clinical studies can be used as the sole support of a premarket approval (PMA) for an in vitro diagnostic (IVD) as long as the data meet specific criteria, the FDA says in a new guidance.