Wednesday, 12 September 2012

What price would you put on your bladder?


My mum is awesome. She is. For a million reasons. This is just one. Here's another. Decades of being a palliative care nurse and undertaking various forms of volunteer work is reason three, four, five, six, seven...

She was born in the war (as she will tell you many, many times, particularly if you ever mention wasting food or throwing anything away), and she hates bananas, and sugar in her tea. She also has bladder cancer.

Now this isn't a why do bad things happen to good people rant. It may still be a rant, but it's a specific rant about the treatment that my mum should be getting and now isn't.

In 2009, 10,540 people in the UK were diagnosed with bladder cancer. When the 2012 figures are released, my mum will make up one of the overall number.

Bladder cancer is the seventh most common cancer in the UK. Cancer Research UK has lots of information about it herehere and here.

My mum was diagnosed earlier this year with pretty advanced, pretty aggressive bladder cancer. She had the cancerous tissue removed, and undertook a six week induction course of intravesical therapy, which involves putting liquid drugs directly into the bladder through a catheter. Because she has a grade 3 tumour, she was given intravesical BCG (yep, the same BCG that resulted in a scar on your upper arm that would get punched at school, but in much higher doses).

Interestingly, no-one's that sure why BCG treatment is so effective for treating bladder cancer, but it is, and it was in the case of my mum. She completed the course, had a follow up investigation, and there was no sign of the cancer having reappeared.

She should now have moved on to what is called maintenance BCG therapy - having it every few weeks or months for the next three years. But she hasn't, because there is a worldwide shortage of it.

Professor Sir Mike Richards, National Cancer Director, notified the NHS about the shortage in a letter dated 6 July 2012. In it, he writes:

"I am writing to draw your attention to the current global shortage of products used to treat patients with bladder cancer"

"Two companies normally manufacture Intravesical BCG. Production of one of the two products (Immunocyst - manufactured by Sanofi Pasteur and distributed in the UK by Alliance Pharmaceuticals) has been stopped and is unlikely to resume before late 2013. The manufacturer of the second product (oncoTICE - MSD) is working hard to increase production, but this will take time"

"In any one year, 2000 patients will receive induction therapy with BCG and a further approximately 4000 will receive it as maintenance therapy"

"Initial estimates are that around 200 (patients) would normally start BCG each month and that 10-20% of these might now undergo surgery. This equates to around 20-40 additional patients undergoing cystectomy for every month that the shortage lasts"

Cystectomy is the partial or complete removal of the bladder. It's also what my mum most fears since being diagnosed.

The British Association of Urological Surgeons also provided information regarding the shortage on its website in July 2012, stating that the 'production difficulties' have not been clarified, but production is unlikely to recommence before the end of 2013.

Sooooo, now that I've set the scene, here's a list of my naive questions, given that hundreds of British citizens will most likely need to have their bladders removed prematurely/unnecessarily as a direct result of the BCG shortage:

1. How often do shortages like this occur?

2. How are existing stocks being rationed?

3. Why is the Secretary of State for Health (previously Andrew Lansley, now Jeremy Hunt) not addressing the patients affected directly and committing to do everything in his power to help resolve it as soon as possible?

4. Sanofi Pasteur is the largest company in the world devoted to vaccines. Why is it not addressing the patients affected directly and committing to do everything in its power to help resolve it as soon as possible? A sprinkler flood affected one of its factories, but why did it then choose to "temporarily suspend manufacturing of all BCG products in order to renovate the factory"? Was there no way in which ongoing production could have been better managed and maintained?

5. Heaven forbid that I encroach upon capitalism, market advantage and patents, but given that we are talking about people's lives, not about delays to the iPhone 555 caused by production problems, is there really no way in which in the year 2012 other companies could have helped manage and maintain production? And if either side needed a helping hand / push / carrot / stick, could Governments not have provided that?

There is clearly a market for the product. There is clearly a serious and urgent need for the product. And yet seemingly nothing is going to happen for more than 12 months.

Can that be right?


P.S. The image at the top of this post comes from this systematic review.


  1. Q1: perhaps more often than we know!
    I went for my chemo treatment for bowel cancer last week and one of the drugs I was due to receive wasn't available due to a national supply issue (i.e. shortage) - unf***ingbelievable!

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