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News and Opinions about MS, Health & Disability

Registry set up to compare approved MS therapies

I think it’s great that therapies approved as treatments for multiple sclerosis are to be compared for safety and effectiveness. The move is long overdue.

Corrona Multiple Sclerosis Registry, which is to carry out the work, has been set up as a result to an important collaboration. A meeting of minds of the US’s National Multiple Sclerosis Society (NMSS) and Corrona led to the launch of the new registry.

effectivenessThe Corrona company is based in Cambridge, Massachusetts, and conducts observational cohort studies. These offer analytic expertise for clinical data, patient-reported measures and others to compare effectiveness, post-market safety reporting and commercial applications.

USA’s Food and Drug Administration (FDA) approved the first MS disease modifying therapy (DMT) in 1993. Today there are many more.

The registry will collect and analyze outcomes associated with several MS therapies. It has already enrolled its first patient, but plans to recruit 5,000 people with MS.

Effectiveness and safety: Data collection lags behind

Founding president of the Medical Partnerships 4 MS, Daniel Kantor, said in a press release: “MS research in the US lags behind other fields in collecting reliable real-world data to compare the safety and effectiveness of these therapies.”

Corronna says the registry will collect data from patients and their treating neurologists through questionnaires. It will include physician assessments and patient-reported outcomes.

Executive vice president of research at NMSS, Bruce Bebo, said: “Identifying the optimal treatment strategy is critical for people with MS and their healthcare providers. The collaboration with Corrona on the MS registry addresses this challenge. It furthers our goal of ensuring that people with MS have information, tools and resources to live their best lives.”

“Corrona is honored to partner with the National MS Society and US neurologists to create a national MS registry that can help guide treatment decisions for patients based on real-word comparative effectiveness and safety analyses,” said Jeff Greenberg, Corrona’s chief scientific officer.

For more information about the Corrona MS Registry, including enrolment details, you can contact ms@corrona.org or call (508) 408-5398.

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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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Mixed messages about beta-interferon safety to treat MS

Research that is meaningful is essential. It is what, after all, what we need to find a cure for multiple sclerosis and other debilitating diseases.

However, a new study from the University of British Columbia, Canada, puzzles me. The study “Evaluating the safety of beta-interferons in MS” looked at potential adverse events when treating relapsing remitting MS (RRMS).

When the findings were published in Neurology, they came with a strangely conflicting narrative.

Let me explain.

Increased risk

The study found an increased risk of events such as stroke, migraine and depression, as well as abnormalities in the blood, when beta-interferon is taken for MS. The team discovered this by analysing the health records of more than 2,000 British Columbians with MS between 1995 and 2008.

beta-interferon

Professor Helen Tremlett.

So, that’s not so good. But Professor Helen Tremlett, senior author of the study, said that beta-interferons have a favourable safety profile, especially compared to the newer therapies for MS. And she added: “That is still the case; our study does not change that.

“However, very few studies had comprehensively and quantitatively assessed their safety in real world clinical practice. Our findings complement and extend on previous observations.”

Tremlett is a Professor in the department of medicine at the Djavad Mowafaghian Centre in Brain Health. She also said: “Once a drug is released on the market, there are very few ways to systematically monitor adverse events. 

“Clinical trials cannot identify all adverse effects of a drug treatment partly due to small sample sizes and relatively short follow-up periods.”

Beta-interferon research undermined?

So, the study shows that people taking beta-interferon for MS are at great risk of having a stroke, migraine and depression, as well as abnormalities in the blood. But they stress that patients and physicians should not change their treatment plans. They say that the risk to individual patients will vary greatly depending on individual factors.

To me that attitude, of ‘yes, the risks are greater but never mind’, devalues the results. In fact, to my mind, it undermines the whole study. The question I must ask is: why waste money on research if you are going to go against the results?

On the plus side, besides the negative effects, Tremlett and her colleagues made a positive discovery. They found a reduced risk of bronchitis and upper respiratory infections with taking beta-interferon for more than two years. These infections can be common and problematic for people living with multiple sclerosis.

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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 has enjoyed a successful career as a journalist, from reporter to editor, in the print media. During that career he gained a Journalist of the Year award in his native UK. Diagnosed with MS in 2002, he continued to work until mobility problems made him retire early in late 2006. He now lives in the south of Spain. Besides MS, Ian is also able to write about both epilepsy and cardiovascular matters from a patient’s perspective. Besides that, he is a keen advocate on mobility and accessibility issues.

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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.

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Danger, corruption and drugs but no rock and roll

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Danger is part of an F1 driver’s life. Carlos Sainz survived this crash during practice for the Russian Grand Prix but other safety lapses need attention. (Pic: Rex)

In life there will always be lots of ups and downs, just ask any sportsman or woman, but sport in general seems to be going through some very hard times at the moment.

Thankfully, the troubles are varied, there does not appear to be one underlying cause. In fact, there are many; so many that it is impossible to mention them all here. That being the case, my remarks will be confined to just a few of them.

Drug-taking has created problems in more than one sport, with athletics and cycling bodies being determined to stamp it out. Both international organisations have chosen new presidents, coincidentally both British, with Brian Cookson now in charge of cycling while Lord Coe is now leading athletics. As Sebastion Coe, he won middle-distance Olympic gold medals in 1980 and 1984.

On being elected in September two years ago, Cookson said: “My first priorities as president will be to make anti-doping procedures in cycling fully independent……..(and) to ensure a swift investigation into cycling’s doping culture.”

Meanwhile Coe’s attitude to drugs in athletics can be shown by his words on being elected in August this year. He said: “There is a zero tolerance to abuse of doping in my sport and I will maintain that to the very highest level of vigilance.”

But the problems in those two sports combined are dwarfed by the goings-on in the world of international football, or soccer, this time not by the players but those who are in charge.

There have been allegations of corruption, illegal payments, unfavourable contracts and vote-buying in the run up to the decisions on where to hold the next two World Cup tournaments.

Internal investigations have taken place, criminal proceedings have been started in Switzerland and the USA, arrests have been made and extraditions started, It’s a mess.

Everyone involved has denied any wrong-doing but now FIFA’s Ethics Committee has suspended international president Sebb Blatter and UEFA (European) president Michel Platini because of criminal investigations.

I have no idea where this is all going to end, how high up the tree the allegations will be proved, but one thing is needed – transparency. Football fans everywhere need to be assured that all the guilty have been removed and steps taken to ensure that nothing like it can ever happen again.

Formula 1, the pinnacle of world motorsport, has its own issues but not of the kind plaguing other sports. In motor racing, the problems seem more about management and engineering shortcomings. The breakdown in the relationship between the Red Bull team and its engine provider Renault is one example of the latter.

The division of F1 income between the teams, however, is pure management of the financial side of the sport. The money is not distributed fairly and, although the top teams would say they deserve the lion’s share, the smaller teams really need greater support for their efforts. If F1 management want small teams to survive, they need more of the cash.

Safety is another area that needs greater attention. Great steps have been taken over many years but it has not been enough. Jules Bianchi died as the result of a crash at the Japanese Grand Prix in 2014; on Saturday, Carlos Sainz suffered a high speed crash in the final practice for the Russian Grand Prix and this just one day after diesel oil was spilled on the track by a truck – although those events do not appear to be connected. And you can add to that the spectacle of an F1 fan walking along the track during this year’s Japanese Grand Prix!

For a sport that prides itself on doing all it can to enhance the safety of everyone involved, whether in-car, in the pit lane and paddock or spectator areas, it is clearly not enough.

I could go on, about deflated balls in American Football and a lot more, but don’t want to risk becoming boring. It all needs to be fixed NOW.

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