Convention to Combat Fake Medicine Signed

(Moscow Times)  Russia, France, Germany and several other mostly European countries on Friday signed the first-ever international treaty to combat the growing multibillion-dollar counterfeit drugs industry.

The Council of Europe-sponsored Medicrime Convention, signed in Moscow, obliges signatory states to criminalize a broad range of activities that make possible the sale of fake medicines that harm patients and deprive legal producers of revenues.  The convention introduces minimum standards for the criminal law of the signatory countries, said Council of Europe media officer Estelle Steiner.

Ambassadors and diplomats of Austria, Finland, Italy, Israel, Iceland, Portugal, Switzerland and Ukraine have signed the treaty. It establishes as criminal offenses such activities as the manufacturing of counterfeit medical products (including equipment), their supply and offers to supply, trafficking and the falsification of related documents.

Many fake drugs contain an insufficient amount of active ingredients, which could cause fatal consequences for the patient.

According to the World Health Organization, counterfeit medical products represent between 6 percent and 20 percent of the market in some parts of Europe.

Malaria vaccine could save millions of children’s lives

Millions of small children’s lives could be saved by a new vaccine that has been shown to halve the risk of malaria in the first large-scale trials across seven African countries.

The long-awaited results of the largest-ever malaria vaccine study, involving 15,460 babies and small children, show that it could massively reduce the impact of the much-feared killer disease. Malaria takes nearly 800,000 lives every year – most of them children under five. It damages many more.

The vaccine has been in development for two decades – the brainchild of scientists at the UK drug company GlaxoSmithKline, which has promised to sell it at no more than a fraction over cost-price, with the excess being ploughed back into further tropical disease research.

“This data bring us to the cusp of having the world’s first malaria vaccine, which has the potential to significantly improve the outlook for children living in malaria endemic regions across Africa,” said GSK’s chief executive, Andrew Witty.

“The addition of a malaria vaccine to existing control interventions such as bed nets and insecticide spraying could potentially help prevent millions of cases of this debilitating disease. It could also reduce the burden on hospital services, freeing up much needed beds to treat other patients who often live in remote villages, with little or no access to healthcare.”

Witty told the Guardian he was thrilled for the scientists who were thought by many of their peers to be attempting the impossible when they started work on a vaccine 25 years ago.

“When the team was first shown the data, quite a number of them broke down in tears,” he said. “It was the emotion of what they had achieved – the first vaccine against a parasitic form of infection. They were overwhelmed. It says something about the amount of heart that has gone into this project.”

In an indication of the weight of expectation around this vaccine, still known only as RTS,S , the results were announced at a malaria forum in Seattle called by Bill and Melinda Gates, with World Health Organisation director general, Margaret Chan, and the UK development secretary, Andrew Mitchell, present. They were published at the same time online by the New England Journal of Medicine.

Small-scale studies, in a few hundred children, have shown promising results in the past, but a trial of this size is needed to prove the vaccine’s usefulness across populations. It is being carried out in seven countries – Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania.

This early data from five- to 17-month-old children is the first of three important results; the second outcome from the vaccination of newborn babies will be published next year. These are crucial, because the malaria vaccine needs to be incorporated into the infant immunisation schedule, alongside the usual diptheria and measles jabs, but earlier small-scale trials suggest the results in six- to 12-week-old babies will also show around 50% protection.

The third important outcome, on how well the protection lasts, will not be known until 2014. The data so far, over 22 months, suggests there may be a drop in the numbers protected from severe malaria from half of children to about a third.

The WHO has said that if the results are satisfactory, it will issue a recommendation for its use and the vaccine may begin to be rolled out as early as 2015, but it will need to be used in conjunction with all the other existing tools of malaria prevention, such as bednets and insecticide spraying on the inside of homes.

Questions remain over the price of the vaccine and whether donors will be willing to pay for it. Dr Regina Rabinovitch, from the Bill and Melinda Gates Foundation, declined to say if they would fund it, saying they would want to look at the final data on efficacy, duration and safety. “Would I prefer to see a 100% effective vaccine? Certainly,” she said in response to questions at a press conference.

Witty says he is exhorting everybody involved in the vaccine’s production to pare their costs to the bone. “We are absolutely dedicated to making it as low as possible,” he said.

Christopher Elias, president and chief executive of Path, a non-profit organisation that has helped fund and push the study on, with the assistance of the Gates Foundation, said such high-quality science was moving the fight against malaria on.

“The Path malaria vaccine initiative’s mission is to deliver a vaccine to the children of Africa so that instead of carrying near lifeless babies to crowded paediatric wards, mothers will carry their infants past noisy school playgrounds to bustling immunization clinics. Today, we are an important step closer to realising that vision, and we look forward to continuing our drive, together with our partners, to bring this vaccine home to the children of Africa.”

Bill Gates said a vaccine is the simplest, most cost-effective way to save lives. “These results demonstrate the power of working with partners to create a malaria vaccine that has the potential to protect millions of children from this devastating disease,” he said

All the children in the trial received three doses either of vaccine or an ineffective placebo.

The analysis published in the journal relates to the first 6,000 children, aged five to 17 months, to be immunised. Over the 12 months after immunisation, the vaccine reduced their risk of developing clinical malaria – meaning the high fevers and chills that need medical treatment – by 56% and of developing severe malaria by 47%. Severe malaria affects the brain, kidneys and blood and can kill. Most children still suffered malaria, but fewer and less serious bouts. For every 1,000 children who received the vaccine there were 750 cases of malaria over a year, compared with 1,500 per 1,000 children who were given a dummy jab. Side-effects were roughly the same in both the vaccine and placebo groups and relatively high, at around 20%, but investigators say this has to do with other health problems among rural African children.

To coincide with the United Nations High-Level Meeting on NCDs, the research-based pharmaceutical industry today outlined the steps it is taking to address the rise of NCDs in the developing world. Building on its Framework for Action released earlier this year, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) revealed the findings of the first report of an independent policy research programme focused on identifying the most significant obstacles to stemming the tide of NCDs in developing countries.

The top line findings of the research show that effective first-line NCD medicines exist and are now available in generic form, but, in many instances, these medicines are still failing to reach many people living in the developing world.

The study identified four priority areas for the research-based pharmaceutical industry to consider:

• innovative ways to improve NCD medicine adherence

• overcoming barriers to availability in poor and remote areas where large mark-ups, tax and duties, along the supply chain, as well as counterfeit products, are an issue

• improving access to primary care

• removing regulatory restrictions that hamper medicine availability in developing countries.

These priority areas provide the basis for the next four studies in the IFPMA NCD research series. The aim is that the studies will help the research-based pharmaceutical industry and its partners develop and carry out the actions that will most effectively improve access to NCD medicines in developing countries. In parallel, IFPMA and its member companies continue investing in NCD health partnerships and prevention programmes.

Eduardo Pisani, Director General of the IFPMA said, “50 percent of NCDs are avoidable, therefore prevention measures, including lifestyle modifications – doing more physical exercise, stopping smoking and a healthy diet – are some of the most cost-effective and efficient ways to tackle the magnitude of NCDs across the developing world. But we know that while prevention is imperative and cost-effective, its impact can only be felt over the longer term. We also need to know how best to improve access to treatments that patients in developing countries need more urgently. The launch of the first in the series of IFPMA reports illustrates how the research-based pharmaceutical industry is committed to this challenge, and how we want to understand what areas require particular focus.”

David Brennan, CEO AstraZeneca and President of the IFPMA said, “The increasing burden of NCDs in low and middle-income countries poses an economic, social and moral stumbling block to global health and prosperity. There is no silver bullet solution because the scale of the problem is so complex. This underscores the importance of partnership to understand what the most significant problems are and to work together to solve them.”

Today, the research-based pharmaceutical companies are committed to 213 health partnerships, a quarter of which deal directly with NCDs or help strengthen the primary care to deliver treatments. The IFPMA is also committed to forging new NCD partnerships. On 12 September, the World Health Professions Alliance announced an NCD Health Improvement Card and toolkit, sponsored by the IFPMA. This NCD toolkit will be shared with over 26 million health care professionals in more than 130 countries to help encourage patients to identify and prevent risky behaviours.

David Brennan explains: “The research-based pharmaceutical industry’s framework for action clarifies many areas where we are already actively making practical contributions. From training healthcare professionals on diabetes in India, to providing state-of-the-art diagnostic equipment to assist in breast cancer treatment in Ethiopia, we continue to invest in programmes that address the public health needs in developing countries by focusing on strengthening healthcare systems, improving health education and building capacity. We all have an interest in ensuring patients in developing countries have access to the care and treatments they need. Effective first-line NCD medicines that were developed by the industry decades ago are now available in generic form; however, in many instances, these are still out of reach for people who need them. Improving access to these and other effective medicines that we continue to develop remains a priority for us all.”

The drugs will be provided to the World Health Organization for use in its Stop Tuberculosis Partnership, with the WHO expected to provide the antibiotics to China’s national tuberculosis programme.

In 1980, before widespread vaccination, measles caused an estimated 2.6 million deaths each year. With accelerated immunization activities spearheaded by governments and the Measles Initiative, global measles mortality has decreased by an impressive 78 percent worldwide from 733,000 deaths in 2000 to 164,000 in 2008. Reductions in measles-related deaths during that same time period accounts for nearly a quarter (24 percent) of the overall decrease in childhood mortality, representing significant progress toward Millennium Development Goal 4 (MDG4).

The measles epidemic affected a total of 115,600 children between January and June, the UN Office for the Coordination of Humanitarian Affairs (OCHA) said in a press release issued yesterday, adding that the vaccination campaign was funded with $1.9 million.

The campaign, which kicked off on 10 May, was coordinated by the UN World Health Organization (WHO) in the provinces of Katanga, Kasai Occidental, Bas-Congo, Equateur and Orientale.  “The funding – equivalent to 61 cents per child – helped protect the health of millions of children,” said Fidèle Sarassoro, the UN Humanitarian Coordinator for DRC.

Measles is a highly contagious viral disease, which mostly affects children. It is transmitted through droplets from the nose, mouth or throat of infected persons. Initial symptoms, which usually appear between eight to 12 days after infection, include high fever, a running nose, bloodshot eyes, and tiny white spots on the inside of the mouth. A rash then develops, starting on the face and upper neck and gradually spreading to the rest of the body.

In malnourished children and people with reduced immunity, the disease can cause serious complications, including blindness, encephalitis, severe diarrhoea, ear infection, pneumonia and even death.

Source – UN Daily News

The Dengue Vaccine Initiative just launched a new site to provide a central resource for information about the disease, vaccines and other efforts.

Substantial progress towards finding a vaccine has been made in the last decade. Several vaccines are in various stages of advanced development, with clinical trials currently underway on five candidate vaccines. Trials in the most advanced stages are showing encouraging preliminary data.

Dengue is a major cause of morbidity and mortality and a leading cause of hospitalization of children in many countries in tropical and subtropical areas of the world. The greatest documented burden of dengue occurs in Asia and Latin America, but the disease is now appearing in previously unaffected areas. The cost of illness to society is considerable, from lost wages and decreased productivity to costs associated with seeking care and direct medical expenses. An estimated 60% of the economic strain caused by dengue is a result of indirect costs. The cost of dengue in the Western Hemisphere alone is estimated at $2.1 billion per year.

Read more about the NCD Framework for Action:

PharmaTimes – IFPMA pledges action on non-communicable diseases

IFPMA – Research-based pharmaceutical industry launches collaborative framework to tackle NCDs

Some of the areas of progress cited were:

• The number of deaths of children under the age of five declined from 12.4 million in 1990 to 8.1 million in 2009, which means nearly 12,000 fewer children die each day.
• Increased funding and intensive control efforts have cut deaths from malaria by 20 per cent worldwide – from nearly 985,000 in 2000 to 781,000 in 2009.
• New HIV infections have declined steadily. In 2009, some 2.6 million people were newly infected with HIV – a 21 per cent drop since 1997, when new infections peaked.
• The number of people receiving antiretroviral therapy for HIV or AIDS increased 13-fold from 2004 to 2009, thanks to increased funding and expanded programs.

The study, which was funded by the Bill and Melinda Gates Foundation and the World Health Organisation, took worldwide data on diabetes since 1980 and found that the number of adults with the disease reached 347 million in 2008. This is more than double the number in 1980 and way up on a previous study in 2009 which put the number worldwide at 285 million.

The results, which revealed that high blood glucose and diabetes are responsible for over three million deaths worldwide each year, show that 70% of the rise was due to population growth and ageing, with the other 30% due to higher prevalence. The proportion of adults with diabetes rose to 9.8% of men and 9.2% of women in 2008, compared with 8.3% and 7.5% in 1980.

The study was co-led by Majid Ezzati from Imperial College London and Goodarz Danaei from the Harvard School of Public Health. Prof Ezzati noted that diabetes “is becoming more common almost everywhere in the world”, which is in contrast to blood pressure and cholesterol, which have both fallen in many regions. Dr Danaei added that “unless we develop better programmes for detecting people with elevated blood sugar and helping them to improve their diet and physical activity and control their weight, diabetes will inevitably continue to impose a major burden on health systems around the world.”

 2.7 million study participants

The study included blood sugar measurements from 2.7 million participants aged 25 or more across the world. It found that diabetes has taken off most dramatically in Pacific Island nations, which now have the highest diabetes levels in the world.

In the Marshall Islands, for example, a staggering one in three women and one in four men have diabetes. Glucose and diabetes were also particularly high in south Asia, Latin America, the Caribbean, Central Asia, North Africa and the Middle East.

However, the rise in diabetes was relatively small in western Europe and highest in North America. Off the richer nations, diabetes and glucose levels were highest in the USA, Greenland, Malta, New Zealand and Spain, and lowest in the Netherlands, Austria and France.

Of the aforementioned 347 million people with diabetes, 138 million live in China and India and another 36 million in the USA and Russia. The region with the lowest glucose levels was sub-Saharan Africa, followed by east and southeast Asia.