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#ThinkSpeak & #PolitcalSpeak: a balancing act

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Safety vs. rare, but life threatening adverse events. #ThinkSpeak #PoliticalSpeak

My oldest daughter recommended I watch the BBC Panorama programme about the HIV contamination of blood products in the 1980s. She is horrified by the Government's response to the crisis and has no doubts about who is to blame. 

It tells a harrowing story of haemophiliacs being saved but a technological advance (Factor VIII concentrate) on the one hand and being exposed to, and infected by, HIV on the other hand. The story is not a simple one. It involves doctors trying to save lives, and improve the quality of life, of their patients with the latest innovations and the perceived slowness of public health officials and politicians to act on an emerging risk of HIV, and hepatitis C, from high risk blood donation practices in the USA. The documentary alludes to the dark arm of the Pharmaceutical industry who were processing, manufacturing, marketing and distributing the Factor VIII concentrate to be responsible, despite no evidence being presented to support the claim. 

The programme raises very important issues about at what point in an emerging epidemic, AIDS in  people with haemophilia in the USA, do public health officials and doctors act? Scotland responded quicker than England and hence the rate of HIV infection in people with haemophiliac in Scotland was half that of England. England is larger than Scotland and it was suggested that they couldn't respond as quickly because of a much greater demand and relatively lower supply of plasma donors in England. 

The story is relevant to MS. When PML emerged as a risk factor for pwMS on natalizumab treatment, Biogen withdrew natalizumab from the market and did a risk assessment. Biogen then relaunched natalizumab with a 'black box' warning and regulators restricted natalizumab to a group of pwMS with very active disease (rapidly evolving severe). Despite the risks neurologists and pwMS continued to use natalizumab with a resulting epidemic of PML that as of the 1st December 2016 there have been 698 confirmed cases of PML (695 with MS and 3 with Chron's disease) with 161 deaths. Who is responsible for these deaths; Biogen for wanting to relaunch natalizumab, regulators for allowing natalizumab back on the market, neurologists for prescribing it or patients for choosing natalizumab over other, albeit limited, options? In my opinion no one is to blame. The relaunch of natalizumab allowed people with very active, and disabling MS, to be treated,  the risk of PML to be better defined and for natalizumab to be derisked. In 2017 there should be very few new cases of natalizumab-associated PML. From a public health perspective the above process saved natalizumab for future generations of pwMS. The sad side of the story is that over 160 people have had to die. In the case of haemophilia-HIV story lessons were learnt and heat-inactivation was rapidly shown to destroy the HIV virus rendering the Factor VIII concentrate safe from HIV. Plasma derived Factor VIII has subsequently been superseded by the development of recombinant factor VIII. 

Are there lessons to be learnt? Yes, transparency and honesty is needed. The Government was not, and subsequently has not been, transparent in relation to haemophilia-HIV epidemic. May be someone in the Department of Health should study the natalizumab-PML story as a case study on how to manage an emerging healthcare crisis. 

We will almost certainly have other crises like this going forward. In the MS space we don't really know what the risk of secondary malignancies is from the various licensed, or to be licensed, MS DMTs. What will happen if in the future a major cancer risk emerges with one of the MS DMTs? Who will be to blame? Sometimes risks only become clear with time and provided we all admit that the risk can't be defined at present and we make sure that all parties are aware of this and then we collect the data and act on it in a timely fashion no one will be blamed and everyone will benefit. 

I have been hypercritical of Genzyme and the emerging Listeriosis crisis with alemtuzumab for similar reasons. It is clear that Listeriosis is a problem with alemtuzumab. However, we have been kept in the dark about the number of cases and the mortality associated with Listeria infection in alemtuzumab-treated patients. The only reference to the number of cases is in the small print of a poster at the AAN that stated the incidence of Listeria to be 0.26%. What we don't know is how many cases have there been and what was the mortality of alemtuzumab-associated Listeriosis. How many cases were meningitic and how many systemic? If only Genzyme could learn from Biogen's experience we would all be in a better place. Genzyme have no idea how difficult they are making if for neurologists on the coalface. What do we tell our patients? Wouldn't it be better if we had hard facts? I would urge Genzyme executives to watch 'Contaminated Blood' and imagine themselves as a patient with MS trying to weigh-up the risks and benefits of the various treatments on offer. 

BBC Panorama. Contaminated Blood: The Search for the Truth. First shown: 10 May 2017

It has been called the worst treatment disaster in the history of the NHS. More than 2,000 people died and thousands more were infected with HIV and Hepatitis C after being treated with contaminated blood products. All the victims were infected over 25 years ago, but even now new cases are still being diagnosed. Survivors and their families are trying once more to persuade the government to hold a UK public inquiry.

Panorama examines recently released documents, and asks if the government could have done more to save lives. The film hears the heartbreaking testimony of some of the victims and their families and explores the dilemmas of doctors who had to carry on treating their patients through the unfolding crisis.

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