Thursday, 23 October 2014

Bad News as first PML case appears to be linked to Tecfidera/BG-12

#MSResearch PML case associated with Tecfidera/BG-12
With every new hope in MS there appears to be a dash to break that hope and news just coming in from Reuters suggests that there has apparently been a case of PML with Tecfidera, which was announced to analysts i.e. investors who promptly dumped stock.

There are scant details at present from Reuters or notably the Company Website .

Was this person on other immunosuppressive DMT before Tecfidera?   Was this associated with a white blood cell count drop? They were apparently on the drug for 4 and a half years,
Is it really PML as the person apparently died of Pneumonia.

However, the New York Times have reported the story the Boston Globe has said that the person had had low white blood cell levels for many years. This means they may not have enough white cells to drive MS, but on the flipside you may not fight infections as well. All of the highly effective MS drugs target a drop in white cells and so PML is a risk. The question remains how low is low? Which cells are the problem.  

Low white cell counts apparently occurs in about 5% of people using Tecfidera and this may take some time to occur. 

There have been cases of PML reported following fumaderm and therefore the risk was there.. for this occurring after Tecfidera. 
This had been put down to the poly-medical mixture of treatments that the affected people were taking. However, the biology indicates that it is a risk of any potent immunosuppressive agent, especially with persistent leucopaenia.  

This is sad news if this media report turns out to be true, however in the media there are quotes from the company supporting the media claims. 

Although, I am not a clinician and as ProfG is away, I would recommend that you do not panic in response to this media alert and stop taking your drug. We need to know more about this case in more detail. Maybe the company will do a press release to clarify this. At present their most recent news was only talking about their large profits.

Remember any change of highly active drugs needs to carefully considered and planned because of the real risk of disease re-activation, we have seen this with people switching from Tysabri. 

Following the news that Tysabri causes some people to get PML a risk management scheme was put in place and I suspect the company will have to think about risk management scheme too, it probably already has. They will be guided by the regulators who apparently have been informed according to the media reports.

Again those who don't have the JC virus will have low risk of PML. As to leucopenia what is the level to avoid and was this the problem? This is impossible to say with just one case. 

Every immunosuppressive drug has side-effect issues,the only way to avoid these is through antigen-specific imunotherapy

Conflicts of Interest of NICE Advisors

There was an apparent report yesterday that Members of Parliament and being asked to investigate the Conflicts of Interest of the Advisors to NICE.

There is a view that people who advise NICE all have conflicts of Interests because they may be recieving funds from pharma. 

If they are not recieving anything from Pharma are these the people we want advising on Pharma Issues, because if they are not advising pharma are they any good? 

The problem is finding a neuro who doesn't have a conflict and importantly as virtual all academic neurologists will have had some dealings with pharma. We could ask were does the funding for regulators come from......Pharma perhaps?

However if the people advising are so in the pocket of pharma, why is it that NICE have delayed and rejected most MS drugs in their time...Which drugs get an easy ride to prescription.

However the central issue is cost, if the drug is expense NICE play a delaying role to beat down the price, if the drug is cheap you don't really need a nice...There seems to be a mess up about over prescribing a statin, it wouldn't have happened if the drug cost more than £2.30 a month:-). Get a cheap drug for MS and you don't have to worry about nice.

However, it is right that the procedures are reviewed such that this can be transparent.