Thursday, 28 June 2012

What is the true cost of counterfeit drugs?

The World Health Organization's International Medical Products Anti-Counterfeiting Taskforce (IMPACT) estimates that fake pharmaceuticals make up one per cent of drug sales in developed countries and approximately 30% in some countries in Asia, Africa and Latin America.

Counterfeit and substandard drugs kill over 100,000 people per year and may indirectly cause the death of nearly 1 million patients.

There is already a great degree of activity in the industry to help boost pharma security, reduce counterfeiting and ultimately protect patient safety and companies' bottom lines, and one growing trend is the use of serialisation systems. Cold Chain IQ editor Andrea Charles recently spoke to economist and author Roger Bate about the cost of counterfeit and substandard medicines to the global economy, where the greatest of counterfeiting threat comes from and the financial impact serialisation initiatives will have on the pharma industry.You can listen to the interview here:

The Financial Impact of Serialisation on the Pharmaceutical Industry

Sumit Dutta
Cold Chain IQ

PS Interested in learning more?

Read “Understanding the Importance of Cold Chain as Part of the Bigger Picture”
with Mohamed Nasser, MD, Eli Lilly Saudi Arabia for more.

Also read: Document written by the World Health Organisation (WHO) on quality control of pharmaceuticals (available in multiple languages)

Wednesday, 27 June 2012

Better Diagnostics Needed to Detect Aspergillosis

Tuberculosis rates worldwide
A recent story in the Malibu Times illustrates how badly we need rapid diagnostics for the detection of infections by Aspergillus. In some acute cases (e.g. if the patient has a poorly functioning immune system i.e. immunocompromised) we can detect aspergillosis but only after several days wait and this can often be too late for the patient.

In the case described in the Malibu Times the person suffering an infection seems to have had a fully functioning immune system but was apparently never diagnosed. Infections of these people (i.e. most of us) can happen if the person has some form of lung damage - perhaps from a different infection many years before and not necessarily Tuberculosis (Tb) which was ruled out in this case.

Infection of people who are not immunocompromised may be far more common than we used to think. Recent estimates suggest around 2% of people who have had Tb will become infected with Aspergillus which equates to nearly 400 000 people worldwide per year with nearly 2 million in total. All of those people need to be quickly and correctly diagnosed and treated with antifungal medication to improve their outlook and help prevent the sudden highly unpleasant deaths like that which suffered by Mr Rodas.

Global prevalence of chronic pulmonary aspergillosis following pulmonary tuberculosis

Tuberculosis (TB) is a common and often deadly disease caused by strains of mycobacteria. It attacks the lungs but can affect other parts of the body. Most infections are latent and asymptomatic - about 10% go on to develop active disease, which if untreated is fatal for about 50% of cases. One of the consequences of pulmonary TB is the development of chronic pulmonary aspergillosis (CPA).

The symptoms of TB are chronic cough, blood stained sputum, fever, night sweats and weight loss. These symptoms are remarkably similar to those of chronic pulmonary aspergillosis which could mean that CPA was underlying and undetected. Approximately one third of the world's population is thought to be infected with mycobacterium tuberculosis, predominantly in the developing world.

In 2007, WHO estimated 7.7million cases globally with 77% having a one year survival. A recent presentation to the British Thoracic Society in London (Denning et al) - analysing the global prevalence of CPA following TB, estimates that 372,000 patients worldwide developed CPA after TB in 2007. The distribution showed a predominance of cases in Africa (98,000), W Pacific (88,800) and SE Asia (145,700). The occurrence will be complicated where immunosuppression and HIV are more prevalent.

The analysis concludes that CPA after TB is a significant public health problem in SE Asia, Africa and W. Pacific areas, but that a lack of research, limits precise estimates of cases, both regionally and globally.

Friday, 22 June 2012

Newsbite: Deidre Wins the Day Against Mouldy Housing

Deidre Lodge has been working tirelessly over the last few years to try to get her local council to take the adverse health effects of allowing people to live in mouldy buildings more seriously. Herself a sufferer of aspergillosis Deidre has worked countless hours supporting local residents and lobbying council officers to look more closely at the problem and at practical ways to improve the situation.

Time after time she was discouraged by comments at meeting that mould was not a serious problem in the home, even when UK government guidelines were put in place that stated that mould in the home should be given the most serious category 1 hazard rating rather than the councils own category 4 hazard rating.

After a full council meeting Thurrock council have now agreed to give this subject some serious attention and has agreed to set up a series of consultation committees.

Newsbite: Alan Turing's 100th Birthday

Happy 100th birthday Alan Turing,  inventor of the free-standing programmable computer, forerunner of the PC we all have it sitting on our desks today without whom we may well not be able to read and write this blog (working at Manchester University, UK)! Not to forget his work as codebreaker in WWII which may have saved millions of lives. more...

Thursday, 21 June 2012

Aspergillosis of the Eye - New Potential for Treatment

Aspergillus infections of the eye are widespread and are relatively common in parts of the world that still commonly use labour intensive agricultural methods e.g. India. In such rural areas there is quite a high risk of people getting irritating foreign bodies into their eyes - commonly grain husks or damage caused by swipes of a cows tail.

The immune system of  the eye is slightly different to that of the rest of the human body. Immune privilege and lack of some inflammatory response enables the eye to carry on functioning if injured, but can also mean that if one eye is injured, both eyes can be lost. For these reasons infections of the eye warrant specialist consideration.

Red stained Aspergillus infecting the eye
This paper used an experimental model to study Aspergillus infection of the eye in which the fungus has been  genetically altered to glow red. This enables it to be easily observed when infecting an eye. This group demonstrate here that neutrophils and their ability to produce reactive oxygen are important for the prevention of infection of our eyes by Aspergillus.

The fungus is known to be able to respond to neutrophil attack by producing their own anti-oxidation chemicals. An important part of the metabolic pathways used by the fungus to produce anti-oxidation chemicals is the gene product Yap-1 so the importance of this gene product was tested in this study and it was found to be important for the establishment of infection of the eye.

As a result of this work we now have new clear targets for the development of new drugs to treat Aspergillus infection of the eye so perhaps there is hope that blindness caused by these infections (often following injury) will effect far fewer people at some point in the future.

Tuesday, 19 June 2012

When Aspergillus is NOT a Girls Best Friend

A recent research paper described a consignment of 100 000 jewelry boxes made in China, bound for a company in France arriving covered in mould - stained inside and out.
Workers refused to handle the boxes and they were send to a laboratory for testing. Aspergillus oryzae (closely related to A. flavus) was identified which closely resembled a strain commonly used for food production in China and Eastern countries in particular - this is unusual and not a strain commonly found in the environment. It is a strain of Aspergillus that is known to occasionally be a human pathogen.

The researchers could not rule out the possibility of this fungal strain producing 'unknown mycotoxins' though they did fail to detect any of several known toxins that were tested for.

If the moulds had been those commonly found in the environment the consignment could well have been cleared for use after cleaning but as this consignment seemed to be contaminated with very few strains (possibly only one) of a fungus not normally found in the environment potential harm to health was not ruled out and the boxes were destroyed.

The authors point out that this incident may be repeated more often in future as global commerce & manufacturing sourcing increases and that great care needs to be taken to prevent contamination of goods at the factory (not allowing the consumption of food in the same place as manufacturing occurs for example) and the accumulation of damp during what is often a lengthy period of transport.

The paper also points out that there may be some toxins hazardous to health  produced by fungi that we don't currently know about or detect, but then seem to only be worried about fungal strains that are not commonly found in the environment. This is a highly cautious approach which probably reflects the need to prevent all possible theoretical risks for the purpose of advising the industry - in point of fact there are many strains of microorganisms that are abundant in the wild capable of producing toxins, many of which we may not know about.

There is a final comment in the paper regarding the treatment of products with biocide
Current regulations (Registration, Evaluation, Authorization, and Restriction of Chemical substances, REACH) now prohibit the use of dimethyl fumarate (DMFu), and this could result in an increase of mold contamination of imported manufactured products. Research should be started to select alternative biocide to replace DMFu.
Overall we must encourage great awareness of the potential for moulds to contaminate goods both during manufacture and transport & storage. Companies were large scale manufacturing of biodegradable goods takes place need to put safeguards in place and companies receiving goods need to be aware of potential health hazards that their workers may come into contact with when opening consignments.

Friday, 15 June 2012

Wounded Soldiers Attacked by Aspergillus Infections

Soldiers sustaining blast injuries in Iraq and Afghanistan have been found to be suffering from invasive fungal infections at a higher rate than that expected. 75 out of 2755 injury cases have been positively identified as invasive fungal infection.

 The victims are mainly those suffering from explosions at very close quarters where large quantities if dust and soil are hurled into wounds, carrying large quantities of fungal spores and other material into those wounds. Until fairly recently no specific antifungal treatment was given until signs of infection were clear, but in many cases this takes days or weeks and in one case this was too late and the patient died of invasive aspergillosis and mucormycosis.

A recent article describes the steps taken to improve speed of diagnosis for these patients (via direct microscopic examination of tissue sections:
Frozen-section histopathology was initially used for diagnosis because of its quick turnaround, but resulted in a 33% negative predictive value in their lab and is no longer used, Dr. Malone said. This led to the 24-hour IFI protocol utilizing permanent sections. Periodic acid-Schiff and Gomori methenamine silver staining have proved efficacious for Aspergillus species, but not as efficacious for identifying Mucorales species. Calcofluor white staining is also used and may allow morphology-based speciation.
These steps decrease the time from injury to diagnosis of an invasive fungal infection from 10 days to 3, thus allowing earlier treatment and hopefully improving outcomes. Antifungal medication is also now given much earlier during treatment when fungal infection is only suspected rather than proven.

This type of injury is of course much rarer in civilian life, but the techniques learned in the intense arena of warfare may well contribute to improving the speed and efficacy of treatment for people suffering from invasive fungal infection after surgery or car accident for example.

Wednesday, 13 June 2012

Newsbite: Fungal Spore Concentration in the Air of Karachi, Pakistan

Dr Panjwani Centre for Molecular Medicine and Drug Research (PCMD) and University of Karachi (KU) recently conducted an aero mycological study to monitor and analyse airborne fungal flora of the Karachi environment. “Airborne fungal spores are well known to cause respiratory allergic diseases particularly bronchial asthma, allergic rhinitis, rhino-conjunctivitis and allergic broncho-pulmonary aspergillosis in both adults and children, especially in humid cities like Karachi." more...

Tuesday, 12 June 2012

200 Years of the New England Journal of Medicine - Aspergillus in the Archives

 The NEJM is one of the worlds most highly regarded and longest lived medical journals with a history that extends back to1812. The journal maintains an archive of all of its publications from the first day it began but sadly full access is restricted to subscribers.

We can however search the archives and we are then given a single page for each result which certainly gives us a strong flavour of how very different medicine was then compared to how it is today (each item in our list below is linked to NEJM archives and when clicked will provide that part of the archive we are allowed to see. This gives us an opportunity to trace a large part of the history of the diagnosis and treatment of aspergillosis as recorded in the pages of this journal.

The Aspergillus Website has carried out a search of the 19th century issues of NEJM (1812 - 1900) for references to Aspergillus and aspergillosis (the name of the infection caused by Aspergillus) and have listed them in a historical timeline. There are 38 items many of which are descriptions of some of the first cases of aspergillosis recorded.

Some articles refer to the beginnings of 'germ theory' and its opposing hypothesis 'spontaneous generation'. At this time (1861) the ancient belief that life occurred spontaneously was weakening after many examples had been demonstrated of life originating from particles. What was not understood was the nature of those particles as they were too small to see. Louis Pasteur in Paris carried out some elegant experiments, including finding fungal spores suspended in the air (as dust) which the NEJM (or as it was known then the Boston Medical and Surgical Journal) published having translated it from the original french. This was the first ever mention of Aspergillus in NEJM.

Take a look at the timeline here

Monday, 11 June 2012

Fuel Made From Woody Plant Material Using Aspergillus terreus

A research group in India has been looking for the best fungal strain to use as the basis of a project to develop biodiesel from plant material that is often thrown away as it is difficult to eat & digest as food for human or animal consumption. This is important to prevent the demand for fuel competing with the demand for food in the developing world - several existing alternatives use crops that can be used for food e.g. soya.

Khot et. al. have searched for isolates adapted to the process of digesting woody material in mangrove swamps, areas where there are already known to be rich in fungal species that can efficiently digest wood.

Oleaginous (oil producing) micro-organisms store oils within their cells as part of their normal process of storing energy for growth. If we can find food for them that we don't use then they will digest material we do not use and turn it into oils that we can use as fuel - all with very little need for energy.

Khot found several isolates from mangrove swamps that happily digested decomposing woody material and turned it into large amounts of oil - and the most efficient with the highest levels of oil produced (greater than 20% of their weight was oil) was an isolate of Aspergillus terreus. It is proposed to use this isolate to further explore the possibility of efficiently generating fuel from waste plant matter.

Monday, 4 June 2012

How Close Are We To Personalising Medicine?

April Cashin-Garbutt, writing for the website has reviewed a little of our progress towards making use of whole genome sequence information that is currently in the process of becoming cheap enough for general use.

April's article is excellent and well worth reading for the average man in the street as it illustrates not only the enormous potential for managing our health when this becomes a reality for most people, but also how far we have already come with our current ability to sequence far smaller parts of our genomes. 

April demonstrates that we have already entered the era of personalised medicine as some treatments are already tailored to the individual needs of some cancer patients

> Quoting April's article

For some tailored medicine for cancer does already exist. A breast cancer drug called Herceptin is already known to work in patients with an overactive HER2 gene.
A knowledge of the genetic basis behind a cancer means that it can potentially be attacked more specifically. For example, in the breast cancers that overproduce HER2, a monoclonal antibody has been developed that causes selective killing of cancer cells, without affecting normal cells which do not overproduce HER2.
This extraordinary technology will gradually become commonplace, enhancing the efficacy of some drugs, minimising side effects of others (familiar to anyine being treated for aspergillosis), cutting waste of drugs that will be ineffective in some people and in the above case enabling the use of specialised drugs that will only be active in a specific group of patients - perhaps eventually down to the individual level in some cases. 

Ethical and moral considerations of Human Genome Research by Craig Venter

There are ethical considerations & objections to be taken in for account, and there is a discussion of some of these is in the above video, but the potential benefits are so huge for us all surely these will be settled.

Friday, 1 June 2012

Englands First Professor of Nursing Dies

1 April 1926 - 13 May 2012

Lady McFarlane of Llandaff
Jean Kennedy McFarlane, Baroness McFarlane of Llandaff, who has died aged 86, was one of nursing's great pioneers. Her work on what has come to be called the nursing process is now an integral part of every nursing curriculum and every nurse's practice.
Jean joined the Victoria University of Manchester in 1971 and became England's first professor of nursing in 1974. Here, she developed a degree course and established the country's first professorial nursing department.
She was also responsible for England's first nursing research programme, and was mentor to many of those who became the nurse leaders of the next generation. She remained at Manchester until her retirement in 1989.
In 2009, the University honoured her when it opened the Jean McFarlane Building - the new home of the School of Nursing, Midwifery and Social Work, the School of Community Based Medicine and the Institute of Health Sciences.

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