Monday, 29 November 2010

Latest update on Isavuconazole trials


Isavuconazole is a novel, water-soluble, broad spectrum antifungal medicine developed by Basilea. It is available in an intravenous form or orally - with high bio-availability, as a capsule. It is currently undergoing multiple clinical trials - for yeast infections, aspergillus infections, aspergillosis in renally impaired patients and for rarer mould infections.

The pharmaceutical companies Astellas and Basilea have a co-development and co-promotion agreement for a worldwide license - agreed earlier this year.

Pre-clinical and clinical data so far indicated that isavuconazole has the potential to overcome many limitations of current therapies for invasive fungal infections. It has predictable and dose proportional pharmacokinetics - which is important to maintain therapeutic drug levels in patients.

Importantly the IV- dose form has a good potential to be given safely to patients with kidney impairment.

The phase III clinical trial for the treatment of invasive aspergillus infections will be continued as recommended by the Data Safety Monitoring Board based on results from the first 180 patients. Basilea and Astellas have announced a change in the primary endpoint for monitoring the phase III trial (more info here) which will mean that the trial will need to show that isavuconazole is actually saving lives instead of just improving clinical symptoms- when compared to first line treatment - in this case voriconazole. Basilea states that this change will not impact on the trial's timeline, which should be complete by early 2011 with results due in 2013. Isavuconazole has been fast tracked in the US by the FDA.

Thursday, 25 November 2010

Advice for people with asthma as temperatures set to plummet

Asthma UK is today urging people with asthma to prepare themselves for the extreme cold weather as Britain braces itself for temperatures reaching as low as -5C this week.

Cold weather can have a severe impact on the 5.4 million people with asthma in the UK. Three quarters of people with asthma tell us that cold air is a trigger for their symptoms and 90% highlighted that having a cold or flu makes their asthma considerably worse.

Cher Piddock, lead nurse for Asthma UK says: ‘Hospital admissions for asthma traditionally peak during periods of particularly cold weather. This can be due to breathing cold air into the lungs which can in turn trigger asthma, as well as picking up colds and flu.

‘People whose asthma is well-controlled are more likely to be able to withstand the dangers of winter months and you can help keep your asthma under control by making sure you have a regular asthma review with your doctor or asthma nurse and that you have a personal asthma action plan. This is a plan which should be completed by your doctor or asthma nurse in discussion with you, and contains the information you need to manage your asthma, including information about your medicines, key things to tell you when your asthma is getting worse and what you should do about it, as well as emergency information on what to do if you have an asthma attack.’

To help minimise the need to go to hospital during this cold spell, Asthma UK is offering the following important advice about how to control asthma symptoms during the cold weather.

5 tips for keeping asthma at bay as the weather gets colder
Asthma UK recommends:

  1. Keep taking your regular preventer medicines as prescribed by your doctor
  2. If you know that cold air triggers your asthma, take one or two puffs of your reliever inhaler before going outside
  3. Keep your blue reliever inhaler with you at all times
  4. Wrap up well and wear a scarf over your nose and mouth – this will help to warm up the air before you breathe it in
  5. Take extra care when exercising in cold weather. Warm up for 10–15 minutes and take one or two puffs of your reliever inhaler before you start.

You might be having an asthma attack if: you are coughing more than usual, experiencing shortness of breath, wheezing, feeling tightness in the chest, having difficulty speaking in full sentences

The steps to take if you are having an asthma attack:

  • Keep calm – do not panic
  • Sit down and try to take slow steady breaths
  • Take one or two puffs of your reliever inhaler (usually blue), immediately

If there is no improvement – Continue to take two puffs of your reliever inhaler every two minutes. You should take up to ten puffs.

Call 999 urgently if:
  • your symptoms do not improve in 5 – 10 minutes
  • you are too breathless to talk
  • you are worried at any time

If an ambulance does not arrive within 15 minutes, repeat step 3 while you wait.

Even if your symptoms improve and you didn’t need to call 999, you should still see a doctor or asthma nurse within 24 hours.

For more information about managing asthma during the cold months please visit asthma.org.uk or call our dedicated asthma nurse specialists on the Asthma UK Adviceline 0800 121 62 44   

Monday, 22 November 2010

Recreational Divers Need Awareness of Aspergillus

A recent case in the diving world has outlined the lethal perils of not thinking before you breathe & ensuring any air you breathe in is coming from a verified clean source.

Mike Firth was a very accomplished recreational diver who was technically capable of diving to depths of 50m (160 feet) in search of rarely found wrecks to explore - not a feat to be taken lightly unless highly trained with a lot of specialist equipment.

In 2008 he started having breathing problems`following dives with symptoms including hacking cough, shaking and intermittantly raised temperature. After some time this was identified as a huge Aspergillus infection (aspergillosis) of his lungs which soon resulted in him being unable to walk for 25m as he rapidly lost lung function.

He was referred to the National Aspergillosis Centre in Manchester, UK which managed to get some control over his symptoms but it was still something of a mystery how this highly fit & active man could be infected by a fungus that normally only affects those who are heavily immunocompromised.

We know that this type of infection can sometimes occurr in a fully fit person if they directly inhaled huge amounts of fungal spores. These spores are incredibly tiny, some being only 2-3micrometre in diameter and as such can penetrate our lung very deeply, ultimately into the smallest air sacs (alveoli) from where if enough spores are involved our immune systems can sometimes be overwhelmed. A recent case involving a person opening a sac of compost for his garden and being exposed to a cloud of spores was probably a similar situation.

In this situation Mike seems to have inhaled spores when testing past of his equipment was working fully. The Bouyancy Compensation Device (BCD) bladder is not part of the normal breathing apparatus (and thus was not subject to the normal routine of cleaning & sterilizing of all parts that are breathed through) but is used to provide bouyancy while the diver swims - it helps the diver maintain a 'flat' position as he swims through the water by being filled with air.

Mike admitted that he liked the safeguard of being able to take a few breaths from the BSD should his main source of air fail while underwater - it was an emergency measure. For this reason he liked to be sure that the tube it was manually filled and emptied from was clear and unobstructed. Prior to going diving he blew into the tube and also sucked to check it worked in both directions, and indeed it checked out perfectly but he remembered that there was a strange taste.

After he was admitted, researchers at the National Aspergillosis Centre tested and verified that the BCD bladder was infested with Aspergillus - consequently Mike would have breathed in large amounts of Aspergillus spores when he sucked air out of the bladder.

Mike's lungs were so badly damaged that his only chance of a cure would now be a lung transplant. He submitted his story to many Divers publications in order to raise awareness of this serious problem and to try to prevent anyone else suffering the same fate as himself. We do it here for the same reason

Friday, 19 November 2010

Mycotoxins Linked to Low Growth Rate in Children

Scientists in Tanzania, Africa have found that one year old children fed on a staple diet of corn flour-based foods tend to consume levels of the mycotoxin fumonisin above that with is considered to be safe. The fumonisin comes from fungi (principally made by Fusarium but also Aspergillus) growing on the corn as it is grown and stored. The contamination can happen invisibly, giving no clues to the farmer that there is a problem and there is no way for most poor farmers to test his crop for mycotoxins.

Corn is staple food in many parts of the world (around a billion tons are produced annually) and is widely grown in warmer climates, so this problem could be far more widely spread than Africa, though in the developed world storage techniques after harvesting and screening for mycotoxins will help prevent the problem cropping up in those countries.

It is thought that this could be an important reason why many of these children have a low growth rate and is in addition to other possibilities such as poor diet and sanitation. Now this problem has been identified steps can be taken to reduce the levels of fumonisin in corn meal fed to humans and in particular young children.

Fumonisin levels are controllable by improving storage conditions and this can be achieved by greater investment in drying machinery and better education of the farmers.

NICE loses power to ban use of new drugs

Many of the new drugs used to treat aspergillosis are extremely expensive to use. A course of Voriconazole to treat a chronic infection for example could cost £30 000 per year. Naturally this causes significant problems for the funding bodies and a decision must be made on whether the cost is affordable and justifiable.

There are several factors taken in for account prior to this decision being made, but one of the basic decisions that have to be arrived at is whether the cost is justified for a given group of patients as judged by questions on how much improvement they will see in their general condition, symptoms, longevity or quality of life. An important part of the answer to some of these questions are published research that demonstrates the effectiveness of a drug for that group of patients.

Once all the information that can be collected to support a particular drug application has been gathered it has to be sent to the organisation required to make the funding decision. In the UK that responsibility belonged to the National Institute for Clinical Excellence (NICE). This single body was able to pass binding resolutions that banned the purchase of any drugs using NHS funds that it found to be too expensive to use considering the benefit it brought a particular group of patients. As you might imagine many battles were fought by patients groups against NICE each time new evidence of efficacy of a new drug came to light, and the decisions of NICE were often controversial.
Decisions often took years to arrive and now health budgets are falling all round the world it is likely that more controversy will follow. Despite this NICE is used as a model system around the world to control spending on drugs.

The UK government is now proposing to take the power to ban the use of new drugs away from NICE and give it to local funding bodies run by local general doctors (GP's in the UK) who they think will be better suited to deciding which patients groups get new drugs. These groups may well be less remote from patients but they will be bound by the same shortage of money that NICE had to deal with - in fact probably worse! At least patients groups can now appeal to authorities closer to home and some may get funding rather than there being a single blanket ban.

NICE had yet to produce guidelines for the use of antifungals in respiratory infections, or at least I cannot find any on their website. They will apparently continue to work on those documents.

So how are antifungal funded for respiratory infections in the UK? The decisions are already made at a local level, currently by the Primary Care Trust. Funding is allowed in the NHS until such time as NICE guidelines say otherwise - and of course now NICE guidelines will not have the power to ban the use of antifungals for this purpose - perhaps that is good news for some patients as the status quo may continue but not for those patients already waiting for funding as they have had funding refused by their local PCT.

Tuesday, 9 November 2010

Migration of Loon 55482 ended by Aspergillosis

The annual migration of the Common Loon (listen to their call ) is regularly followed by scientist from the Upper Midwest Environmental Centre in Wisconsin, USA. Little is known about their route after they leave their inland breeding lakes with many turning up on the Atlantic shoreline weeks later.
This study is an important part of efforts to care for the welfare of this bird as once it is known where it goes and how long it stays in various places then we can start to take action to reduce the hazards - natural and man made - that these birds come across on their journey.
In order to track these birds nine were given a radio transmitter implant and the re-released. The signal from these implants can be picked up by satellite telemetry and the location of each bird recorded at regular intervals. The locations are presented for each bird here - remarkably viewers can follow the route as the bird migrates.

Unfortunately one bird was tracked to its doom. Loon 55482 was tracked over 500 miles to the shores of Green Bay near Lake Michigan whereupon it stopped moving. It remains were found and a post mortem revealed that it had died of pulmonary aspergillosis.

This is usually a symptom of a bird that has become stressed by lack of food/poor food/exhaustion/cold/age weather as under these condition their immune system tends to work less well and they can become infected - much as happens in humans when their immune system fails. Perhaps in this case exhaustion was a key as it was a member of the group that seems to have migrated the furthest?

Wednesday, 3 November 2010

Regulation of herbal remedies in Europe

April 1st 2011 marks the day when all products sold as herbal remedies or food supplements (including fungi) over the counter in the European Union will have to conform to new regulations. Specifically they will have to have:
  1. Proved to the satisfaction of the regulatory authority that the drug has a beneficial effect
  2. Be provided with full instructions on what specific use the medication is intended for and how to use it
  3. Be proven to have no harmful effects
In other words, herbal remedies will have to pass some of the regulatory checks that 'conventional' drugs have to pass prior to going to market.

There is some opposition to the new regulations as there are large numbers of herbal medications that will have to comply and relatively little time to do so (though the industry has known that this regulation was coming into force since 2004).
Sceptics may say that the herbal industry will not be happy because many of their current medications have no scientific evidence to support their use and little hope of obtaining any proof  because they are either ineffective or testing would cost too much money. They may also argue that many herbs have been in use for thousands of years and thus must work and must be safe otherwise they would no longer be used.

Hard headed scientists would no doubt contend that if a substance cannot be proven to be effective or safe then it has no business being sold by multibillion dollar industries as remedies for a multitude of ills, regardless of their quaint antiquity.

There does still seem to be a way to access otherwise illegal herbalist remedies after April 1st and again this looks like an effort to bring them into line with 'conventional' drugs - these remedies will still be available via qualified herbalist practitioners after consultation with the patient.

From a neutral viewpoint it is difficult to criticise the new regulations. If the remedy has never been tested and proved to be safe & effective then its sale is at best a gamble for the patient. At worst a patient may feel embarrassed about telling their doctor about this untested remedy or feel that because it is marketed as a 'natural' product it must be harmless. They may then experience harmful effects caused by taking it alongside a conventional drug ordered by their doctor.

Once the regulations are in place people will be able  take a herbal remedy with more confidence that it has a proven value and that it is safe on its own and alongside other medications - the remedies move out of the 'housewives cure' category and into the realm of a properly verified treatment.

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