Dy­ing pa­tients seek­ing drugs may not see much change with new law

Connecticut Post (Sunday) - - Business -

Cancer pa­tients who have run out of op­tions are the largest group that could ben­e­fit from the new Right to Try law in­tended to ease ac­cess to ex­per­i­men­tal drugs, thanks to the more than 1,000 on­col­ogy medicines in de­vel­op­ment in the U. S

But don’t ex­pect the flood­gates to open.

That is the con­sen­sus that emerged from more than two dozen in­ter­views at the re­cent Amer­i­can So­ci­ety of Clin­i­cal On­col­ogy meet­ing in Chicago, the big­gest cancer gath­er­ing in the world. Bloomberg talked to ex­ec­u­tives at phar­ma­ceu­ti­cal gi­ants from Merck & Co. to John­son & John­son; small biotech­nol­ogy com­pa­nies de­vel­op­ing what could be­come the hottest new treat­ments; and doc­tors at the fore­front of on­col­ogy re­search.

Merck, which has the block­buster cancer drug Keytruda and a pipe­line of ex­per­i­men­tal prod­ucts, typ­i­fied the in­dus­try’s view­point — that an ex­ist­ing sys­tem to pro­vide des­per­ate pa­tients ac­cess to ex­per­i­men­tal drugs works well enough. The drug­maker was one of the big winners at the Chicago meet­ing, pre­sent­ing data show­ing Keytruda pro­longed the lives of pa­tients with ad­vanced lung cancer longer than chemo­ther­apy.

“The best form of ac­cess is an ap­proved drug,” said Roy Baynes, se­nior vice pres­i­dent of global clin­i­cal de­vel­op­ment at Merck Re­search Lab­o­ra­to­ries. But be­fore a treat­ment is on the mar­ket, “there are ways, par­tic­u­larly if there is un­met med­i­cal need and there is noth­ing in the space, there are al­ready mech­a­nisms that can be ac­ti­vated.”

Akey com­po­nent of Right to Try is to al­low dy­ing pa- tients who run out of op­tions, through their doc­tors, to di­rectly ask drug­mak­ers for ac­cess to medicines un­der de­vel­op­ment, elim­i­nat­ing the Food and Drug Ad­min­is­tra­tion from the process. The goal was to re­move a hur­dle, al­though the FDA said that it has ap­proved more than 99 per­cent of ap­pli­ca­tions un­der its ex­panded ac­cess pro­gram.

“I’m not sure it re­ally changes things for pa­tients,” said Joanne Lager, head of on­col­ogy de­vel­op­ment at French drug­maker Sanofi. “I haven’t heard of any cases where a pa­tient wants a drug, the com­pany wants to give it and the FDA has said no.”

At the Chicago con­fer­ence, some doc­tors ex­pressed con­cern that des­per­ate pa­tients may be taken ad­van­tage of .

Gisueppe Del Pri­ore, chief med­i­cal of­fi­cer at Tyme Tech­nolo­gies Inc., agreed.

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“Peo­ple might be tempted to cir­cum­vent them; it could be dan­ger­ous,” said Del Pri­ore, whose small biotech firm is work­ing on its first cancer drug and has an ex­ist­ing process in place to pro­vide the treat­ment for com­pas­sion­ate use.

Tri­bune News Ser­vice

Pres­i­dent Don­ald Trump re­acts af­ter sign­ing into law the “Right to Try Act” in­tended to ex­pand ac­cess by ter­mi­nal pa­tients to in­ves­ti­ga­tional drugs on May 30.

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