Drugs, risks, spending cuts, deaths, new drugs, and so much more

As we reach the start of another year, it seems a good time for me to review the last 12 months, as seen through the eyes of 50shadesofsun.com.

January

The year began by focusing on hematopoietic stem cell transplantation (HSCT). Dr Denis Fedorenko of the HSCT centre in Moscow published a guide to the procedure.

Russian Physician’s Guide to HSCT in Moscow

people withFebruary

UK government policies grabbed my attention, along with actions regarding people with disabilities and benefits to which they are entitled.

Disabilities: Government loses tribunals, then changes rules

Disabilities: Government warned forced activities ‘could make health worse’

More flock to accuse disability assessors of lying

March

New treatments came to the fore this month. Ocrevus gained approval from the FDA, while Zinbryta got the go ahead for use in the UK.

After Long Wait, Zinbryta Gains Approval in Areas of the UK

Ocrevus: Counting Down to Expected FDA Approval

April

Allegations had been made that new disability access policies at Disney parks was discriminatory. However, a court decided that the new way of doing things was perfectly ok.

Disney Disability Access Rules Don’t Break Law, Court Rules

May

MS treatments were in the spotlight once again. Questions were being asked about the drug safety and why many people choose to avoid them.

Mixed messages about beta-interferon safety to treat MS

Why are DMTs – Drugs to treat MS – Resisted by so Many?

June

My attention was caught by one of the UK government contractors trying to put the chaotic assessment process behind it. It chose to change its name but that was fooling no one.

I also looked at the much valued and desired matter of independence.

Atos tries to escape its past though superficial rebranding

Even a little independence is a great feeling

July

Risks appeared on two fronts. First, death and serious injuries to patients to the use of Zinbryta being limited in Europe. Second, people with disabilities in the UK were still facing the risk of benefit cuts.

Zinbryta use restricted in Europe after a death and four serious liver injuries

Disability benefit cuts are still a real risk

August

Issues with lack of balance and mobility means that falls are a frequent reality. However, not all falls are the same.

I also looked at MS treatments and how close we might be to finding the holy grail – a cure.

Falls – the good, the bad, and the ……

Cure for multiple sclerosis: Are we close?

September

Inside criticism surfaced about mismanagement of disability benefits. Nothing new to me but good to have confirmation from within. On the same tack, the UK government department responsible for benefits was trying to hide assessment problems.

Talking of confirmation, my theory the MS is linked to glandular fever, or mononucleosis, was backed by researchers.

Department helpline worker lambasts mismanaged disability benefits system

I said it 14 months ago, now researchers agree: MS is linked to ‘mono’

DWP fights to hide WCA ‘under-performance’ and PIP assessments

October

A number of drugs were labelled ‘rip-offs’ in a new report. These included MS drug alemtuzumab.

UK government officials proved they do not understand variable conditions, such as those experienced by people with MS.   

MS therapy alemtuzumab is named a ‘rip-off’ drug, report

Disability benefits stopped because government doesn’t understand variable conditions

November

The number of people wth MS in the USA is more than double that previously thought. Could that be similar elsewhere?

We knew UK spending cuts were dangerous but now we know that they have ben responsible for needless deaths.

Nearly 1 million Americans have MS, not 400,000 as previously thought – NMSS Study

Needless deaths caused by government spending cuts

December

Great to see the doctor who first suggested CCSVI treatment could help people with MS now agrees this isn’t true.

However, shocking to see that someone assessed as ‘fit to work’ died before the appeal could be heard.

CCSVI treatment does NOT work for MS, says clinical trial

Assessment disgrace: ‘Fit for work’ man dies before ESA appeal can be heard

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Affiliate disclaimer: This affiliate disclosure details the affiliate relationships of MS, Health & Disability at 50shadesofsun.com with other companies and products. Read more.

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50shadesofsun.com is the personal website of Ian Franks, a freelance medical writer and editor for various health information sites. He enjoyed a successful career as a journalist, from reporter to editor in the print media. He gained a Journalist of the Year award in his native UK. Ian received a diagnosis of MS in 2002 and now lives in the south of Spain. He uses a wheelchair and advocates on mobility and accessibility issues.

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Note: Health-related information available on 50shadesofsun website is intended for your general knowledge only and is not a substitute for medical advice or treatment for specific medical conditions. I am not a doctor and cannot and do not give you medical advice. You should seek prompt medical care for any specific health issues and consult a doctor before starting a new diet or exercise programme. Any opinions expressed are purely my own unless otherwise stated.

Zinbryta use restricted in Europe after a death and four serious liver injuries

The European Medicines Agency (EMA) has restricted the use of multiple sclerosis drug Zinbryta. The agency took action after a patient died from liver injury (fulminant liver failure). The patient was in an ongoing observational study. Four cases of serious liver injury have also been reported.

We are all likely to experience some side effect of any medication we take, whether for multiple sclerosis or some other disease. Most of us, hopefully, will only have minor problems, if any, but some will be badly affected.

All medicine manufacturers provide a list of their drugs’ side effects, from major to minor, from common to rare. Pharmaceutical companies provide this information for the benefit of patients, not just healthcare professionals.

And, we need to take those lists seriously. After all, it is our health that is on the line.

I always pay close attention to news of new drugs approved for use in the treatment of MS. But, no matter how good the claimed benefits appear, I focus on the possible side effects admitted by the manufacturer.

Now, that is not to say that all disease modifying therapies (DMTs) are bad for us. But we need to balance benefits against the disadvantaged of possible side effects. Everyone must make their own decision.

Such decisions are personal. I have never accepted any DMT.

Zinbryta – liver damage risk known when approved

zinbrytaZinbryta (daclizumab) is one such DMT and its side effects include the risk of liver damage. The EU knew this when it approved the drug in July 2016. In fact, it put several measures in place to manage this risk. These included the requirement to monitor liver function and provide educational materials to healthcare professionals and patients on the risk of liver damage.

Now, though, a year later, the EMA has provisionally restricted the use of the medicine to:

  • patients with highly active relapsing remitting MS (RRMS) that has failed to respond to certain other treatment, and 
  • patients with rapidly evolving relapsing MS who cannot be treated with other medicines.

In addition, doctors must not give the medicine must to patients with liver injury.

It is not recommended for patients with autoimmune conditions other than MS. Medical professionals should be cautious when the give Zinbryta together with medicines that can damage the liver. Doctors are advised to monitor the liver function of patients to whom they give the medicine. They should closely watch patients for signs and symptoms of liver injury.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has issued these provisional recommendations as a precaution and to ensure that Zinbryta continues to be used as safely as possible while a review of its liver safety is ongoing.

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Affiliate disclaimer: This affiliate disclosure details the affiliate relationships of MS, Health & Disability at 50shadesofsun.com with other companies and products. Read more.

* * * * *

50shadesofsun.com is the personal website of Ian Franks, a Features Writer with Medical News Today. He enjoyed a successful career as a journalist, from reporter to editor in the print media. He gained a Journalist of the Year award in his native UK. Ian received a diagnosis of MS in 2002 and now lives in the south of Spain. He uses a wheelchair and advocates on mobility and accessibility issues.

 

Balancing safety with ‘thrills and spills’ of sport

nick blackwell_edited alonso crash_editedMarch 26: Boxer Nick Blackwell stopped by Chris Eubank Jnr.  March 20: Fernando Alonso walks away from the wreck of his car.

Why do you do it?

That’s a question posed to or asked of people who do things that they enjoy but carry a very real risk of injury, permanent disability or even death. The fact that they continue to do what they enjoy in the full knowledge of the dangers involved is, probably, the reason for that question.

Mountaineers climb mountains ‘because they are there’, racing drivers are motivated by speed and determination to be the best, boxers love the thrill of a fight, team players love their various contact sports – and so the list goes on and on.

Sky-diving, skiing, sailing and so many more all have their own risks.

In the last couple of weeks, we have seen two serious sporting incidents. In one, boxer Nick Blackwell, aged 25, was carried from the ring on a stretcher and placed in an induced coma as he had a brain bleed. In the other, double world motor racing champion Fernando Alonso, 34, walked away with just some fractured ribs from a horrifying accident in Australia. That was a testament to the great steps taken to protect drivers in Formula One. Alonso’s McLaren-Honda car was demolished but he was protected; a few years ago, an accident like that would have likely resulted in death.

On the playing fields, over the last year, the world has seen the death of cricketer Phillip Hughes, aged 25, after he was hit on the back of his neck by a ball during a match in Sydney; and at least 11 high school American Football players died last year, either from head or neck injuries or heat-related illnesses.

Rugby players now face mandatory concussion assessment and lengthy treatment protocols before being allowed to play again. This was introduced after some were allowed to play on, risking even more serious injury, instead of being replaced immediately.

There is no doubt that sporting bodies are intent on improving the safety of the contestants but there is only so far they can go without ruining the spectacle of the event.

Boxing injuries have to be assessed minute by minute by the referee who only calls for a doctor if he thinks it is necessary. Should a doctor have the power to intervene without being called by the referee?

Safety equipment, such as cricketers’ helmets, is always being reviewed and improved. The only way to improve rugby safety is likely to be rule changes to minimize risk of injury.

Thinking back to my sporting days, I played club cricket without a helmet or forearm protection and played (field) hockey for a club as goalkeeper also without a helmet. Why no helmet? In those days they hadn’t made it into common use. In fact, cricket helmets were not developed until the late 1970s.

Extremes: Communities can recover, lives lost cannot

Tornados in Texas.

Tornados in Texas.

Bad weather happens. We expect that, to a greater or lesser degree depending where we live in the world; sometimes where we live in a country.

From time to time, extremely bad weather happens. That, too, we expect but usually it can be predicted in certain areas.

Hurricanes, tornados, severe snowfalls, monsoons and so on tend to be restricted to particular regions. They still hit hard but through years of experience the authorities evolve better systems of protection and recovery.

It is important to make it absolutely clear that this blog is not referring, in any way, to natural disasters such as earthquakes and tsunamis – although they, too, are restricted to different regions.

What is disturbing about the current rash of storm force winds and flooding in both USA and the UK is that they are happening at the same time. And, while the US is used to encountering extreme weather conditions, the killer tornados now hitting the southern states have arrived months before the usual tornado ‘season’.

Added to that, the storm winds have arrived with the seasonally-expected snow and, together, that has led to a warning that the forecast 18 inches of the white stuff could lead to drifts up to 10 feet deep.

As I write this, 43 deaths have been confirmed across the south with several state governors each declaring a ‘state of emergency’.

A State of Emergency can be declared when a Governor believes a disaster has occurred or may be imminent that is severe enough to require State aid to supplement local resources in preventing or alleviating damages, loss, hardship or suffering.

It authorises the Governor to speed State agency assistance to communities in need. It enables resources to be made available immediately to rescue, evacuate, shelter, provide essential commodities (such as heating fuel and food) and even to quell disturbances in affected localities. It may also position the State to seek federal assistance when the scope of the event exceeds the State’s resources.

However well prepared they are in the US and other countries, the UK is notorious for its lack of readiness. The problem really seems two-fold. Firstly, they don’t believe they will experience very bad weather or, if they do, it will not happen very often; and, secondly, the cost of preparations and defences against a possible but unlikely threat will be too high.

They are the twin reasons why homes and businesses, indeed whole communities, across a wide area of northern England as well as some in Wales and Scotland, have been flooded. In some places, a month’s worth of rain fell in one day. Drains could not cope with the extra volume, rivers burst their banks and flood defences proved to be less than adequate.

Rooftop rescue in UK.

Rooftop rescue in UK.

People have been evacuated, some have had to be rescued from homes or trapped cars, farm animals have been swept away, army units have been sent to help in the worst affected areas. So far, there have been far fewer deaths in the UK but even one is too many.

The Government has said it will look again at flood defence spending in the wake of the deluge that has left thousands of communities flooded. Meanwhile, the Environment Agency said the number of properties at the highest risk of inundation could rise by 60% from current figures of 560,000, as it outlined a new five-year strategy, including plans to protect an extra 200,000 homes and businesses from flood waters.

It really is time that all authorities, everywhere, prepared properly for extreme weather, however unlikely such an event may seem to be. They need to put effective defences in place to protect their communities.

There should be no budgetary limits, no thoughts of value-for-money. No-one should try to put a value on a human life. It is about time that authorities realised that for every dollar, pound or euro spent on preventing a disaster, much more would need to be spent on recovery.

Also, if disaster is not prevented, while communities can be rebuilt, a human life once lost cannot be recovered.