Canada’s pa­tients need the ‘Right to Try’

The Aurora (Labrador City) - - EDITORIAL - Leo Plumer St. John’s

Ter­mi­nally ill pa­tients should have ev­ery chance to ac­cess po­ten­tially life-sav­ing treat­ment.

This is com­mon sense to vir­tu­ally ev­ery­one. We like to think that our health-care sys­tem does the best it can. Health Canada’s re­view and ap­proval process at­tempts to en­sure that only safe, ef­fec­tive treat­ments go to mar­ket, while help­ing to fund new re­search.

How­ever, this process can take many years and dol­lars be­fore bear­ing fruit. While drugs are stuck in a reg­u­la­tory bog, pa­tients with life-threat­en­ing dis­eases may ex­haust con­ven­tional op­tions for treat­ment, and be stuck wait­ing for new ones, or hop­ing to be se­lected for clin­i­cal trial. Cru­cial drugs may some­times be avail­able over­seas, but can­not be pre­scribed in Canada be­cause they haven’t been li­censed here. Not un­com­monly do pa­tients pass away or suf­fer ter­ri­bly in the mean­time.

If this sounds un­con­scionable to you, then you’re not alone. In Canada and the United States, “Right to Try” (R2T) move­ments have taken root, ar­gu­ing to al­low ter­mi­nally ill pa­tients ac­cess to un­proven treat­ments as a last re­sort. Thirty-three U.S. states have man­aged to pass R2T laws, with over­whelm­ing bi­par­ti­san sup­port. In Canada, this is reg­u­lated at the fed­eral level, and we have taken only baby steps.

Health Canada has a spe­cial ac­cess pro­gram for un­ap­proved phar­ma­ceu­ti­cals which at­tempts to of­fer a way around bar­ri­ers. But ap­pli­ca­tions must pass through Ot­tawa, and the cri­te­ria can be re­stric­tive. Nor does it ad­dress dis­in­cen­tives to drug com­pa­nies to of­fer up their ex­per­i­men­tal prod­ucts.

In re­sponse, a group of amy­otrophic lat­eral scle­ro­sis (ALS) pa­tients has cam­paigned for R2T in Canada — many are par­tic­u­larly in­ter­ested in stem cell treat­ments. They pro­pose a stream­lined process, with el­i­gi­ble pa­tients by­pass­ing bu­reau­cracy and work­ing closely with doc­tors and re­searchers. The pa­tient, pro­vid­ing full in­formed con­sent, would as­sume all risk in try­ing the drug.

This is not un­like ex­ist­ing leg­is­la­tion in the U.S., which stip­u­lates that a pa­tient is el­i­gi­ble for R2T pro­vided they have ex­hausted all other op­tions, and that the drug has passed Phase 1 safety tri­als.

As with any vul­ner­a­ble group, there is po­ten­tial for ex­ploita­tion. Would Big Pharma at­tempt to rip off those who don’t know bet­ter? For­tu­nately, it’s worth not­ing that a pa­tient’s trusted physi­cian would be the in­ter­me­di­ary. R2T law could man­date that all prior in­for­ma­tion on the drug be made avail­able to the physi­cian, who could then ed­u­cate the pa­tient on risks and ben­e­fits. Ad­di­tion­ally, these drugs would be those al­ready in clin­i­cal tri­als, in­tended for fu­ture sale. A com­pany would not risk its rep­u­ta­tion and mil­lions of dol­lars of in­vest­ment to rip off a small pool of brave pa­tients. No­tably, most com­pa­nies al­ready pro­vide drugs through the spe­cial ac­cess pro­gram at a steep dis­count or en­tirely free; plus, there’s no rea­son these costs can’t be cov­ered by our ex­ist­ing health-care sys­tem.

A more com­pelling ob­jec­tion is that com­pa­nies have lit­tle in­cen­tive to re­lease these drugs to the pub­lic. Not­with­stand­ing that many firms al­ready do (where al­lowed), this may be more of a case of dis­in­cen­tives. As it stands, many com­pa­nies have lim­ited funds, mostly ded­i­cated to get­ting through ap­proval. Yet, there’s no rea­son why firms couldn’t sell will­ing buy­ers (or the gov­ern­ment) the drugs at cost, to com­pen­sate them.

An­other im­por­tant dis­in­cen­tive is the need for a good trial record to present to reg­u­la­tors. Any cases of ad­verse ef­fects or in­ef­fec­tive treat­ment serves as a knock against the drug, and most com­pa­nies are acutely risk-averse in this re­gard. A pos­si­ble fix could be to ex­clude from the eval­u­a­tion the drug’s track record in R2T. In­deed, the pur­pose of clin­i­cal tri­als is to be test­ing the drug in a con­trolled en­vi­ron­ment. R2T is there to save lives, not to give data for an eval­u­a­tion.

Fun­da­men­tally, it comes down to con­trol over one’s life. Re­mem­ber, we have re­cently le­gal­ized the “right to die,” which rests on sim­i­lar premises. It seems per­verse to al­low the ter­mi­nally ill ac­cess to as­sisted sui­cide, but not a chance to fight back.

Ac­tively pre­vent­ing a con­sent­ing, com­pe­tent adult from tak­ing a risk to save their own life is pa­ter­nal­is­tic at best, and nearly cruel at worst. For op­po­nents of R2T, this truth may be a pill too hard to swal­low.

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