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Convoluted conversations


Convoluted conversations

Our correspondent discovers that when it comes to genomics, it appears that the genie's out of the bottle.

I occasionally get sent press releases that some kind soul in the editor's office think might interest me. This one was headed: "Sangamo announces UK authorization of clinical trial evaluating zinc finger nuclease in vivo genome editing treatment for hemophilia B".

Headlines are supposed to sell a story. If so, this one didn't do it for me. I've never heard of Sangamo and I don't have a clue what a "zinc finger nuclease" is.

In the hope of some enlightenment I continued to the opening paragraph, which told me that the MHRA had granted the company a clinical trial authorisation. The paragraph concluded with: "The CTA allows for the initiation of Europe's first in vivo genome editing study".

I ploughed on, then did a quick double take - the first European in vivo genome editing study. Surely this is something of a milestone?.

It transpires that the company aims to treat haemophilia B by using its proprietary zinc finger nuclease (ZFN) genome editing technology to insert a corrective gene into a precise location in the DNA of liver cells, with the goal of enabling a patient's liver to produce a stable supply of Factor IX protein.

To restrict the gene editing to liver cells, the ZFNs and the corrective gene are delivered in a single IV infusion using AAV vectors that target the liver. The ZFNs enter the cells as inactive DNA instructions in a format designed only for liver cells to unlock. Once "unlocked", the ZFNs then identify, bind to and cut the DNA in a specific location. Using the cells' natural DNA repair processes, liver cells can then insert the corrective gene for Factor IX at that precise location.

Well, I get the big picture, but the detail of "how" is way beyond my understanding- and, yes, I did go to Wikipedia to find out what AAV vectors are. Trease & Evans was at the cutting edge of pharmacy science when I was a student, and things have clearly moved on since then. Last month I recall reading somewhere that the Department of Health and Social Care's 100,000 Genome Project has reached its halfway mark in sequencing 50,000 human genomes from patients with rare diseases and their families, and that this sets the UK on track to fully realise the potential of genomic medicine.

At a more mundane level I see that Lloydspharmacy has teamed up with an outfit called myDNA to offer what is described as a "breakthrough in personalised weight management". It offers a DNA testing kit that "examines key genes that impact on your diet, appetite and body fat, [and] takes these insights to provide an innovative, personalised diet report and sample meal plans based on your unique DNA profile". It will cost you £59 and looks a bit gimmicky, as many diet related products do, but no doubt Lloyds has done its market research and think it will sell.

What all this tells me is that genomics is no longer fascinating science, but is "coming to market" and it's time I learned a little more about what it all entails. Yet another CPD opportunity - as if you need one! Where
do you go to learn about this kind of thing, though? CPPE does not look as though it has much to offer...

Meanwhile, back with the reality of community pharmacy... It's good to see that dialogue continues between PSNC and the DHSC. Given the hard time contractors have faced over the past couple of years, some might even take comfort from the news that fees and allowances will remain unchanged for the time being.

I'm not one of them, and am wary of the DHSC's future intentions for NHS community pharmacy services since, unlike in Scotland, there has never been a clearly articulated policy (or if there is, it isn't being well communicated).

I am intrigued, though, by PSNC's announcement that "interim arrangements have been put in place because the DHSC and NHS England are not yet in a position to begin negotiations for 2018/19. PSNC has put forward proposals about how it wishes to develop future community pharmacy services, and we hope to begin formal negotiations soon."

So what are these proposals? There was talk of community pharmacies taking on the management of patients with long term conditions. Can we anticipate a shake-up of the existing contract? I hope our own negotiating body is not going to adopt a "mushroom management" approach and keep us all in the dark about its plans to develop community pharmacy services.

And doesn't PSNC have some unfinished business following last year's judicial review of the decision by the Health Secretary to impose funding cuts on community pharmacies?

I had pretty much forgotten that leave to appeal had been granted after the court's decision went against PSNC. The latest on PSNC's website - dated December 2017, so not exactly recent - says the appeal was listed to be heard between January and March.

Unless a pharmaceutical "D notice" has been slapped on proceedings, I haven't heard about the appeal. A search on casetracker. (wonderful thing, the internet, and you need to spell out PSNC in the search window) indicates the appeal is due to be heard on May 22.

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