mPedigree awarded $200,000 in Global Security Challenge

mPedigree was recently announced as the Best Security Start-up in 2010 by the Global Security Challenge.  mPedigree from Ghana is the first system in the world which enables consumers and patients to verify the authenticity of their medicines by sending a free text message of the unique, product-embossed codes.

Across the developing world, especially in West Africa, the issue of fake and counterfeit medication has become a huge problem – the WHO estimates that in many emerging markets, up to 30% of drugs are compromised. The growing sophistication of cheap graphic software and hardware kit means that packaging, including traditional security features such as holograms, can be perfectly replicated by even smalltime counterfeit operators making the need for a highly robust but economically feasible system urgent.

While being just as robust as emerging methods such as EMID and RFID, and far more secure than holograms, the mPedigree approach is widely accessible through basic text messaging, requires no specialist equipment or training, is free to access for consumers, and a fraction of the price of holograms, and RFID and EMID techniques.

mPedigree has been awarded $200,000 sponsored by the Technical Support Working Group of the US Department of Defense and mentorship from Advent Venture Partners.

Vaccine link to autism based on falsified data

The controversial study linking the measles mumps and rubella (MMR) vaccine to autism was based on falsified data and “manufactured at a London medical school,” according to a report in the British Medical Journal.  The investigative report includes a number of findings which suggest that the team at the Royal Free medical school, led by Andrew Wakefield, were not guilty of bad scientific practice but in fact engaged in deliberate fraud.

Wakefield et al sparked a major health scare when their paper was first published in The Lancet in 1998 linking MMR vaccine to a syndrome characterised by autism and bowel disease, with the after effects still apparent to this day.

Articles, editorials, tweets and other posts about this scientific fraud have been widely published following the release of this report, including:

• PharmaTimes - MMR link to autism based on falsified data, says BMJ study
• National Post editorial board: Lying about autism
• TIME – Study Linking Vaccines to Autism Is “Fraudulent”
• The Telegraph - The MMR scare was ‘deliberate fraud’ the British Medical Journal has said
• The Times of India - Study linking childhood vaccine to autism a fraud

US Bill proposes to strengthen drug safety laws

Leaders of four committees in the US House of Representatives have introduced a bill — Drug Safety Enhancement Act (Bill HR 6543) — which would upgrade America’s prescription drug safety laws.  This Bill proposes to equip the FDA with the authorities and resources it needs to adequately regulate the growing global marketplace for drugs.

HR 6543 would:

• create an up-to-date registry of all drug facilities, both foreign and domestic, serving US consumers;
• generate funding for increased Good Manufacturing Practices (GMP) inspections for brand and generic drugs;
• require parity between foreign and domestic inspections;
• prohibit entry of drugs coming from domestic and foreign facilities that limit, delay or deny FDA inspections;
• prohibit the entry of drugs into the US lacking documentation of safety;
• require manufacturers to know their supply chain, identify and mitigate risk throughout the chain, and to document measures taken to secure their supply chain;
• prohibit false or misleading reports to FDA;
• provide strong new enforcement tools, including mandatory recall authority, increased civil and criminal penalties and new FDA authority to subpoena records related to possible violations;
• provide protection for whistleblowers who bring attention to important safety information; and
• require unique identification numbers for drug establishments and importers to improve the FDA’s ability to identify parties involved in a crisis situation more quickly.

In 2009, there were a record 1,742 drug recalls in the US – a fourfold increase from the prior year – and the vast majority were related to manufacturing quality and testing.  Up to 80% of the active ingredients in US drugs are now made overseas, many in countries where regulatory oversight does not meet U.S. standards.

Source:  PharmaTimes.

 

Google and Microsoft help fight illegal internet pharmacies

Bloomberg reports that Google Inc. and Microsoft Corp. are helping to establish a nonprofit organization targeting illegal Internet pharmacies in support of Obama administration efforts.  The group is comprised of companies that serve as Internet choke points and was in response to a call from the administration for private efforts to police illegal pharmacies, said Victoria Espinel, the White House intellectual property enforcement coordinator.

Counterfeit drug sales account for about $75 billion in global sales, according to the National Association of Boards of Pharmacy. An estimated 1 percent to 2 percent of drugs in North America are counterfeit, according to the group’s website.

Companies participating in the effort include Yahoo! Inc., MasterCard Inc., Visa Inc., American Express Co., GoDaddy.com Inc., Neustar Inc., eNom Inc. and EBay Inc.’s Paypal Inc.

Google vs. illegal online pharmacies

On its official blog, Google says that it has filed a civil lawsuit against advertisers it believes has deliberately broken its rules in regards to obtaining prescription medication.  Scores of online pharmacies have set up shop and offer to illegally sell prescription medication over the Internet.

In recent years, we have noticed a marked increase in the number of rogue pharmacies, as well an increasing sophistication in their methods. This has meant that despite our best efforts, a small percentage of pharma ads from these rogue companies is still appearing on Google.

Rogue pharmacies are bad for our users, for legitimate online pharmacies and for the entire e-commerce industry—so we are going to keep investing time and money to stop these kinds of harmful practices.

– Google blog posting

Last year, Google filed a similar lawsuit against “Google Money” scammers (source: Mashable.com). As Google continues to rise in importance to brands and companies, keeping its search results and advertisement sanitized remains crucial for maintaining Google’s reputation.

WHO begins 63rd World Health Assembly – focus on disease prevention, MDGs and patient safety

Sixty-third World Health Assembly

Date: 17–21 May 2010
Location: Geneva, Switzerland

The 63rd session of the World Health Assembly began today in Geneva and will continue through to the 21 st of May. At this session, the Health Assembly will discuss a number of technical and public health issues, including:

• Monitoring of the achievement of the health-related Millennium Development Goals;
• Prevention and control of non-communicable diseases;
• Implementation of the International Health Regulations (2005);
• Public health, innovation and intellectual property:  global strategy and plan of action;
• WHO’s role and responsibilities in health research;
• Infant and young child nutrition; and
• Counterfeit medical products.

The Health Assembly will also discuss the programme budget, administration and management matters of WHO.

Source:  from Global Health Progress

Patient safety and counterfeit medicines

Discussions around counterfeit medicines – and the definition thereof — are heating up again prior to the start of the World Health Assembly.  While this has become a contentious issue, all sides can agree that counterfeit medicines pose a global public health risk, leading to resistance to treatment, illness, disability and even death.

A series of principles on counterfeit medicines were recently released by IFPMA to refocus attention on this important public health issue.  Key points included:

• Medicine counterfeiting is first and foremost a crime against patients.
• Counterfeit medicines threaten the full spectrum of legitimate medicines.
• Government regulatory and enforcement authorities must be fully vested with the proper power and adequately resourced to fight counterfeits.
• Global cooperation is needed.
• The leadership of the World Health Organization is crucial.

Stopping the international trade in counterfeit medicines is vital.   As the leader on global health matters, and particularly with respect to threats to public health in developing countries, the World Health Organization has a key role to play.

The bottom line is that patients – in developed and developing countries – need to be protected.

Internet drug sales to be included in new EU legislation aimed at preventing counterfeits

European parliamentarians voted yesterday in favor (51-0) of including Internet drug sales in European Union (EU) legislation aimed at preventing counterfeit medicines from entering the supply chain.

Under the proposal, Internet pharmacies would have to obtain special authorizations in EU member states where they are allowed to operate. Their sites would be required to bear a EU logo to indicate that they are linked to an authorized pharmacy, and they would be listed in a European database.

Mandatory safety features such as seals or serial numbers would be required for prescription medicines, although this obligation could be waived, for example in the case of generics, subject to an assessment by the European Commission.

They have also called for stronger sanctions against drug counterfeiters, supporting proposals from the Council of Europe to make the trade a criminal offence.

The European Parliament is due to vote on the Falsified Medicines Directive in July.

The economic impact of IP infringement: a report from the U.S. GAO

The United States Government Accountability Office recently released a report on efforts to quantify the effects of counterfeit goods (Intellectual property:  observations on efforts to quantify the effects of counterfeit and pirated goods).

Intellectual property is an important component of the U.S. economy, however the report noted that the illicit nature of counterfeiting and piracy makes estimating the economic impact of IP infringements extremely difficult.

The report covered a wide range of industries, but of particular interest to patients is the information on counterfeit medicines.  Between 2004 and 2009, counterfeit pharmaceuticals accounted for 5% of all goods seized by Customs and Border Protection.  In 2009, 91 percent of the counterfeit goods from India were pharmaceuticals and perfume.

Counterfeits threaten public health in Peru

The prevalence of counterfeit medicines in Peru has increased annually (since 2005) by an average of 45% – representing a significant threat to patient safety and public health.  Nearly a quarter of the counterfeit medicines found by Peru’s National Quality Control Center did not contain any active ingredient, providing no health benefit or protection to patients.