Daily Mail

Can­cer drugs de­layed by up to 14 years – and it’s down to red tape

- By Ben Spencer Med­i­cal Cor­re­spon­dent

Can­cer pa­tients’ lives are at risk be­cause red tape means it takes 14 years for cut­ting edge medicines to reach them af­ter be­ing patented, ex­perts have warned.

New can­cer drugs are tak­ing longer to get to pa­tients than they did a decade ago be­cause of de­lays in the drug de­vel­op­ment and reg­u­la­tory sys­tems, ac­cord­ing to a re­port by the In­sti­tute of Can­cer Re­search.

Drugs that do come through are fo­cused on a tiny mi­nor­ity of can­cer types – with not a sin­gle new medicine in­tro­duced for blad­der, brain or oe­sophageal tu­mours in nearly two decades.

the youngest pa­tients are also miss­ing out, with only 6 per cent of new can­cer drugs since 2000 li­censed for chil­dren.

Pro­fes­sor Paul Work­man, chief ex­ec­u­tive of the In­sti­tute of Can­cer Re­search, said a ‘herd men­tal­ity’ among drugs com­pa­nies is slow­ing down in­no­va­tion. the com­pa­nies are go­ing af­ter the same drugs in the search of prof­its, he said, mean­ing very few truly in­no­va­tive treat­ments reach the NHs.

‘Can­cer pa­tients do bet­ter when they are given ac­cess to the best treat­ments as early as pos­si­ble,’ Pro­fes­sor Work­man said last night. ‘Our anal­y­sis shows that pa­tients are wait­ing longer than be­fore for new can­cer drugs to be­come widely avail­able on the NHs. Can­cer won’t wait and pa­tients shouldn’t have to ei­ther.’

Be­tween 2000 and 2008 it took an av­er­age 12.7 years for a can­cer drug to go from get­ting a pa­tent to be­ing ap­proved for NHs pa­tients by drugs watch­dog Nice – the Na­tional In­sti- tute for Health and Care Ex­cel­lence. Be­tween 2009 and 2016 the time from pa­tent to pa­tient in­creased to 14.1 years, the re­port au­thors found.

‘I don’t think this is about be­ing over­cau­tious about safety – this is reg­u­la­tory red tape,’

‘Tak­ing new ap­proaches’

Pro­fes­sor Work­man said. He warned tri­als are tak­ing longer be­cause of new reg­u­la­tions over data use and the way stud­ies are con­ducted. and, even when they are com­plete, reg­u­la­tors take months to make de­ci­sions. Drugs are nor­mally re­jected on the grounds of cost ef­fec­tive­ness. Nice has tried to tackle this by start­ing ap­praisals ear­lier – of­ten be­fore li­cens­ing has been com­pleted – but de­ci­sions have barely sped up. Drugs took an av­er­age of 16 months to go through Nice ap­praisal be­tween 2009 and 2016, com­pared with 16.7 be­tween 2000 and 2008.

Of 175 drugs given a safety li­cence be­tween 2000 and 2016, 64 – more than a third – were for blood can­cers such as leukaemia and lym­phoma. twen­tythree were for lung can­cer and 15 for breast can­cer.

Only six were for prostate can­cer and four for pan­cre­atic can­cer. there were no au­tho­ri­sa­tions at all for brain, oe­sophageal, blad­der or womb can­cer. Only ten of the 175 au­tho­ri­sa­tions were for treat­ing chil­dren.

Cost ef­fec­tive­ness is the usual rea­son for not li­cens­ing a drug.

Pro­fes­sor Work­man said ‘no­body is pri­ori­tis­ing in­no­va­tion’, with phar­ma­ceu­ti­cal com­pa­nies each try­ing to de­velop al­most iden­ti­cal drugs.

Nice is not help­ing this ten­dency, ap­prov­ing only 38 per cent of drugs it as­sessed which work in a com­pletely new way or for a new can­cer type – com­pared to 53 per cent of drugs that are very sim­i­lar to ex­ist­ing treat­ments.

Dr Olivia Ros­sanese of the In­sti­tute of Can­cer Re­search, said: ‘We need more drugs tak­ing new ap­proaches to tar­get­ing can­cer, rather than more of the same “me too” drugs.’

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