International action needed to tackle fake drugs trade

Substandard and fake medicines harm and kill patients - urgent action needed to tackle this scandal, say experts.

A global treaty is urgently needed to tackle the deadly trade of substandard and fake medicines, say leading experts in a paper published on bmj.com.

Their call comes just days before 100 World Health Organisation member states hold their first meeting to discuss the problem, and the authors hope it will help to influence the debate and lead to some concrete actions.

The lethal meningitis outbreak in the US due to contaminated steroid injections has again highlighted the serious consequences of this global problem. Other recent examples include a heart medicine containing a toxic overdose of a malaria drug, which led to 125 deaths in Pakistan, and a fake cancer medicine containing starch and acetone trafficked to Canada and the US. The extent of harm to patients is still unknown.

Substandard and fake medicines harm and kill patients, write an international group of experts led by Amir Attaran from the University of Ottawa in Canada, with the help of the World Federation of Public Health Associations, International Pharmaceutical Federation and the International Council of Nurses.

In poor countries, the World Health Organisation estimates that over 10 percent of medicines may be “counterfeit” and, although medicine safety is better in rich countries, fake drugs still cause thousands of adverse reactions and some deaths. In the European Union medicines are now the leading illegitimate product seized at the border, increasing 700 percent from 2010 to 2011. Yet despite years of debate, no agreement on how best to tackle this scandal has been reached, they argue.

They say that progress on the twin challenges of safeguarding the quality of genuine medicine and criminalising falsified ones “has been held back by controversy over intellectual property rights and confusion over terms.”

They believe that to move forward, several challenges must first be overcome.

For example, anti-counterfeiting laws must shift from protecting commercial interests to protecting public health interests; there must be clear, internationally agreed definitions for different types of illegitimate medicines; and more transparent surveillance and research is needed to measure the global scale of the problem.

“We argue that tackling the challenges of poor quality, unsafe medicines requires a comprehensive global strategy on which all stakeholders agree,” say the authors.

They point to other global treaties, for example on human trafficking or money laundering, that “have helped governments strengthen their laws and cooperate internationally to clamp down on the havens.”

They also point out that under today's leading public health treaty - the Framework Convention on Tobacco Control (FCTC) - the law is now tougher on fake tobacco than on fake medicines.

They urge WHO to embark on a similar process to that used to create the FCTC, which they believe “avoids unnecessary controversy and can better enable governments, companies, advocates, and the health professions to protect the public's health.”

-MNT

Skin cancers and sun exposure

Those who work outdoors with resultant sun exposure are at increased risk for non-melanoma skin cancers, such as squamous cell carcinoma and basal cell carcinoma.

Manige Fartasch shows that the connection between occupational UV exposure and squamous cell carcinoma is now well-established in her review article in issue 43 of Deutsches Arzteblatt International (Dtsch Arztebl Int 2012; 109(43): 715-20).The results are less clear for basal cell carcinoma, another form of non-melanoma skin cancer. Skin cancers caused by UV light have not yet been considered work-related diseases in accordance with the Ordinance on Occupational Diseases (BKV, Berufkrankheitsverordnung).

These cancers in the accepted list of occupational diseases is being discussed.

For now, the authors recommend that if a squamous cell carcinoma is suspected of being caused by occupational UV exposure, it should be reported as a quasi-occupational disease under §9, paragraph 2 Social Security Statues (SGB, Sozialgesetzbuch) VII. The authors also call for preventive measures for workers with increased occupational UV exposure.Non-melanoma skin cancer is the most common cancer in Western lands with an incidence of around 10 per 100,000 inhabitants in Europe. Pale individuals with a sun-sensitive skin type are especially likely to be affected.

- MNT

Pneumonia - still number one killer but there are simple solutions

Marking the fourth annual World Pneumonia Day, November 12, world leaders and the Global Coalition Against Child Pneumonia are calling for major efforts in the fight against childhood pneumonia, which remains the number one killer of children under age five. Pneumonia claimed 1.3 million lives in 2011 alone, and was responsible for nearly one in five global child deaths.

“Pneumonia can be prevented and cured. Yet, for too long it has been the leading cause of global deaths among children. We know what to do, and we have made great progress - but we must do more. We must scale-up proven solutions and ensure they reach every child in need,” said UN Secretary-General Ban Ki-moon, who spearheads Every Woman Every Child, an umbrella movement that has leveraged more than $20 billion in new money for women's and children's health and aims to save 16 million lives by 2015.

Investments in preventing, treating, and protecting children against pneumonia have contributed to significant declines in child mortality over the past decade, but access to healthcare facilities and treatment remains out of reach for many children in the developing world, where 99 percent of deaths from pneumonia occur.

According to the Global Coalition Against Child Pneumonia, country leaders and funders must prioritise efforts and investments in proven interventions, including access to vaccines, proper antibiotic treatment, and improved sanitation, as well as the promotion of practices such as exclusive breastfeeding, frequent hand washing, care seeking, and the use of clean cookstoves to reduce indoor air pollution. Several of these interventions also help address the second leading killer of children - diarrhea.

For pneumonia cases that do occur, antibiotics such as amoxicillin are one of the simplest and least expensive methods of treatment.

However, antibiotics are administered to less than one third of children with suspected pneumonia, and only a tiny minority receives amoxicillin in the ideal form for small children: a tablet that dissolves in a very small amount of liquid or breast milk. According to the UN Commission on Life-saving Commodities for Women and Children, making amoxicillin available in a dissolvable tablet form to the children most at risk of dying from pneumonia would potentially save 1.56 million children over five years.

According to a Pneumonia Progress Report released by the International Vaccine Access Center (IVAC) at Johns Hopkins, 75 percent of all childhood pneumonia deaths worldwide occur in just 15 countries, demonstrating the impact we can have with targeted efforts. The report also notes that none of these countries have reached the 90 percent coverage targets for key pneumonia interventions recommended in the Global Action Plan for the Prevention and Control of Pneumonia (GAPP).

GAPP, issued by the World Health Organization (WHO) and United Nations Children's Fund (UNICEF) in 2009, specified that child pneumonia deaths could be reduced by two-thirds if three child health interventions - breastfeeding, vaccination and case management including the provision of appropriate antibiotics - were scaled up to reach 90 percent of the world's children.

Over the past three years, the GAVI Alliance has assisted over 20 countries to introduce the pneumococcal conjugate vaccine, which prevents the most common cause of childhood pneumonia. While progress is being made, currently only seven of the 15 countries profiled in IVAC's report have vaccine coverage levels at or above 80 percent. Coverage of breastfeeding and access to antibiotics are similarly low in most countries.

Key to getting vaccines and treatments to the children who need them most are frontline health workers, who are the first and often only link to healthcare for many children.

However, WHO estimates there is currently a shortage of at least one million frontline health workers, particularly in Africa and parts of Asia. Efforts such as Save the Children's Every Beat Matters campaign are bringing attention to this shortage to spur action.

- MNT

Preterm - infants born between two and six weeks

Delivery at any time before the 39th week of gestation increases the risk of postnatal problems and mortality. A team of authors has analysed mortality and morbidity data from epidemiological studies of infants born between two and six weeks preterm, comparing them with infants born at full term. They present their findings in issue 43 of Deutsches Arzteblatt International.

As a rule, elective Caesarean sections are performed somewhat before full term, in order to prevent spontaneous delivery. However, the earlier delivery occurs, the greater the risks to the child. The risk of neurological complications or death rises from 0.15 percent for births at 39-41 weeks’ gestation to 0.66 percent for births at 35 weeks’ gestation.

A higher percentage of children born before term require special educational support in elementary school. This may be one reason preterm birth is associated with an increased risk of subsequent entitlement to welfare benefits. Overall, approximately 20 percent of all children born in Germany are two to three weeks preterm, and 5 percent are 4 to 6 weeks preterm.

The authors therefore advocate establishing clear prohibitions and informing parents, in order to reduce dramatically the rate of elective deliveries before the 39th week of gestation. Attempts to do this in US hospitals have so far been successful.

- NYT

Brain gene APOE e4 linked to dementia

A gene with links to late-onset dementia is also suspected of boosting people's brains in their youth, according to a study.

People who inherit one copy of the gene variant, known as APOE e4, have up to four times the normal risk of developing Alzheimer's disease in later life.Neuroscientists tested the cognitive skills of those with the gene variant, which is found in around a quarter of the population, against those without it.

They also looked at the brain structure and brain activities of both groups during the tasks.

The study, led by the University of Sussex, found that young people with the same variant performed better in attention tests, including episodic memory of words and spotting number sequences.

Experts suggested that while the e4 variant might help boost the brain in early life, it could also increase the possibility of “burnout” in old age.

Lead researcher Prof Jennifer Rusted said: “Earlier studies suggested that those with the e4 variant outperform those without it in tasks such as memory, speed of processing, mental arithmetic and verbal fluency.

“But it is also well-established that this gene is a risk factor for Alzheimer's disease.

“The suggestion is that while this confers cognitive advantages in early life, leading to higher achievement, it may also increase susceptibility to memory failure as we enter old age.

“Our study is the first to show that subtle differences in the structure and activation of the brain during cognitive tasks in APOE e4 carriers are linked to their cognitive performance.

“It is possible that the brain over-activations that we see in youth have negative effects over the longer term and contribute to a kind of ‘burnout’ in older adulthood.”

The study - APOE e4 polymorphism in young adults is associated with improved attention and indexed by distinct neural signatures – was funded by the Biotechnology and Biological Sciences Research Council and is published in NeuroImage.

- PA