Breaking news: What can MSers learn from Cladribine tablets being brought to market?

Breaking news: What can MSers learn from Cladribine tablets being brought to market?


One last question. What can the MS community
learn from the challenges of bringing cladribine to the market? What can… I think people have got to understand
that drug discovery and drug development takes decades. I mean this was
a repurposed drug, this drug came out in the eighties to treat a type of leukaemia called
hairy cell leukaemia. It went into MS at the Scripps Institute in the nineties, then got
bought by a pharma company in early 2000 and then the whole development programme, getting
a licence, all took 15 plus years. So there is no rapid, I mean the whole regulatory environment
around drugs now is so complicated, there is no rapid path to people with MS,
they’ve got to appreciate that. Things have to be
done according to the rulebook, and those take time. I mean each phase of drug
development takes time, and also the costs of the, what they call the final phase, which
is the Phase III programme, is so, so high, you
know, it’s billions of dollars, billions. And so the
pharmaceutical companies have to de-risk that as much as possible and they therefore have
to do the, what they call the initial phases, very carefully to make sure that when they
do go to Phase III at least they are loading the
dice as much as possible to get a positive result.
And every time they have a negative study, they’ve just wasted, you know, maybe one,
one and a half billion dollars. And, you know,
they are public companies, they have shareholders and their shareholders get very upset with
them when they lose money, so their shareholders want them to make money. Interestingly
enough, most of the shareholders are, you know, Joe Soap, people living in
the general community. Because pharmaceutical companies are called blue chip because they
tend to deliver profits regardless of what happens in the economy, because everybody
needs to be treated, and so the people that hold the shares are usually your pension funds
and they rely on a pharmaceutical company to deliver profits for, to pay our pensions.
And so a lot of people don’t understand the
economics and the way pharmaceutical companies have to work. They try not to be too high
risk, but they have to take risks to get therapies, so it’s a balancing act. Anyway, the other
thing we’ve got to realise is, it’s almost impossible nowadays in the modern era to develop
pharmaceutical products outside of a big pharmaceutical environment, it’s just too risky, too
expensive and we can actually do what we would call innovative proof of concept, but to get
to the next stage you need enormous investment. And so this is another example- some
people are criticising this as they’re just another repurposing, pharmaceutical companies
taking a low risk, but it wasn’t. I mean the company almost didn’t get this drug
to market, and so they did take a risk and they spent
quite a substantial amount of money developing 2 the product. But the good news is that NICE
has considered the price, whatever it is, to be
cost effective, and so therefore it’s worth spending that money on people who are eligible
for the drug, because in the long run it’s going
to save the NHS money, so I think that’s what we
have to be positive about it.

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