War on can­cer, take two

Modern Healthcare - - NEWS - By Sabriya Rice and Maria Castel­lucci

With the sign­ing of the Na­tional Can­cer Act and the re­quested ap­pro­pri­a­tion of $100 mil­lion for re­search, Pres­i­dent Richard Nixon launched the first “war on can­cer” in 1971. It was a cam­paign “to find a cure.” To give hope to can­cer pa­tients, Nixon as­serted dur­ing a tele­vised ad­dress that ev­ery­thing pos­si­ble “will now be done.”

The past 40 years have brought a greater un­der­stand­ing of the dis­ease’s ge­nomics and the re­lated mor­tal­ity rate has dropped by 23% since 1991, trans­lat­ing to more than 1.7 mil­lion deaths averted through 2012. Yet op­ti­mism about find­ing cures has tem­pered, damp­ened by high drug costs, lack of col­lab­o­ra­tion and un­ful­filled prom­ises.

“Let’s make Amer­ica the coun­try that cures can­cer once and for all,” said Pres­i­dent Barack Obama, re­ceiv­ing a round of ap­plause dur­ing his fi­nal State of the Union ad­dress. Obama tasked Vice Pres­i­dent Joe Bi­den with spear­head­ing a new “moon­shot” ap­proach to fight­ing can­cer. Bi­den said he would break down si­los that pre­vent datashar­ing and ul­ti­mately, “make a decade worth of ad­vances in five years.”

Last week, some of that work be­gan. The Na­tional Can­cer In­sti­tute said it would launch a data­base this sum­mer that con­tains in­for­ma­tion about ge­netic mu­ta­tions and can­cer treat­ments. Data will come from as many as 50,000 pa­tients and clin­i­cal-trial par­tic­i­pants in the Ther­a­peu­ti­cally Ap­pli­ca­ble Re­search to Gen­er­ate Ef­fec­tive Treat­ments pro­gram, as well as the Can­cer Genome At­las.

“There’s never go­ing to be (just) one cure,” said Dr. Julie Vose, pres­i­dent of the Amer­i­can So­ci­ety of Clin­i­cal On­col­ogy. Can­cer is thou­sands of dif­fer­ent dis­eases. Pre­sen­ta­tions and treat­ment can vary from pa­tient to pa­tient. Vose warned that it’s “im­pos­si­ble to gen­er­al­ize treat­ments to all pa­tients with can­cer.”

To that end, ASCO is­sued a timely pol­icy state­ment last week not­ing how the per­son­al­ized na­ture of can­cer treat­ment has re­sulted in a flood of clin­i­cal path­ways—pro­to­cols that guide which treat­ment should be cho­sen for a pa­tient’s spe­cific di­ag­no­sis. The ad­min­is­tra­tive bur­den of man­ag­ing those path­ways “is at a break­ing point,” ex­perts say.

Also at a break­ing point are the over­whelm­ing costs of con­duct­ing clin­i­cal re­search, com­par­ing ex­ist­ing ther­a­pies and the steep prices that pre­clude some pa­tients from af­ford­ing life-sav­ing treat­ment.

The num­ber of Amer­i­cans tak­ing at least $100,000 worth of pre­scrip­tion drugs an­nu­ally from 2013 to 2014 tripled, ac­cord­ing to Ex­press Scripts. High-cost can­cer med­i­ca­tions were partly to blame.

The most promis­ing re­cent ad­vance­ments— such as im­munother­apy, which uses the body’s nat­u­ral de­fenses to fight can­cer—could cost as much as $130,000 for a 12-week course of treat­ment. On­col­o­gist Dr. Peter Eisen­berg at Marin Gen­eral Hos­pi­tal in Green­brae, Calif., said he is fed up with pre­scrib­ing “fab­u­lously ex­pen­sive and marginally ef­fec­tive” drugs.

And prof­i­teer­ing from drugs is a trend that “shows no sign of slow­ing,” added Dr. Lee New­comer, se­nior vice pres­i­dent of on­col­ogy, ge­net­ics and women’s health at Unit­edHealth­care. To help con­trol costs, the in­surer—the largest in the coun­try—in 2009 launched a col­lab­o­ra­tion with five on­col­ogy groups. They use a value-based pay­ment model based on best prac­tices and pa­tient out­comes.

The na­tional fo­cus on qual­ity and value has also bol­stered in­ter­est in com­par­a­tive ef­fec­tive­ness stud­ies that as­sess the mer­its of new drugs. But even that re­search faces chal­lenges.

A 2014 NCI anal­y­sis found that some can­cer drugs are so ex­pen­sive they hin­der post-mar­ket tri­als that com­pare which ones work best. It’s not in the best in­ter­ests of the man­u­fac­turer of a more ex­pen­sive drug to pro­vide free med­i­ca­tion for those tri­als, mak­ing it nec­es­sary for a third party to fi­nance the re­search. A study com­par­ing the brand and generic ver­sions of two prostate can­cer drugs could rack up to $70 mil­lion in drug costs alone, the au­thors wrote. On­col­o­gists have urged changes in fed­eral law to al­low Medi­care to ne­go­ti­ate drug prices.

Dr. Vin­cent DeVita, for­mer di­rec­tor of the NCI and a pi­o­neer in on­col­ogy re­search, ar­gues that the U.S. Food and Drug Ad­min­is­tra­tion could help by speed­ing up the ap­proval process, which now can take more than two years. “The abil­ity to in­no­vate is gone,” DeVita said. “The FDA has be­come the on­col­o­gist.”

Also, the na­tion’s in­vest­ment in can­cer re­search has been drop­ping since 2003, partly be­cause the NCI has lost nearly 25% of its bud­get, the agency said. Its bud­get was in­creased by $260 mil­lion in the re­cent 2016 bud­get, but the agency had re­quested more. Ad­di­tional fund­ing could help cover ex­penses for trans­porta­tion and lost work time, is­sues that of­ten pre­vent par­tic­i­pa­tion in clin­i­cal tri­als.

Less than 5% of adult pa­tients par­tic­i­pate in stud­ies, ac­cord­ing to ASCO. And as physicians see more pa­tients in the chang­ing health­care cli­mate, they may be too busy to dis­cuss the op­tion.

Most pa­tients don’t even know to ask about stud­ies, said Dr. Michael Sei­den, chief med­i­cal of­fi­cer of the US On­col­ogy Net­work and McKes­son Spe­cialty Health. In light of the chal­lenges seen over the past 40-plus years, ex­perts say any new ap­proach to cur­ing can­cer, moon­shot or oth­er­wise, must get back to the ba­sics.

His­tor­i­cally, clin­i­cal break­throughs, in­clud­ing drugs and other ther­a­pies, have been the shiny new thing. Most re­cently, the pend­ing 21st Cen­tury Cures Act aims to fast-track the most promis­ing treat­ments. But the “gee whiz stuff” isn’t all there is to it, said Dr. Len Licht­en­feld, deputy chief med­i­cal of­fi­cer for the Amer­i­can Can­cer So­ci­ety.

Ef­forts to re­duce obe­sity and smok­ing and boost ac­cess to pri­mary and preven­tive care could sig­nif­i­cantly cut the can­cer mor­tal­ity rate. “We could do much bet­ter in co­or­di­nat­ing our ef­forts in that re­gard,” Licht­en­feld said.

Eisen­berg added that spe­cialty can­cer drugs have di­verted at­ten­tion from re­search into the chro­mo­so­mal ab­nor­mal­i­ties that re­sult in can­cer vari­a­tions among pa­tients. “Ba­sic re­search is not very sexy,” he said. But “if we bet­ter un­der­stood the sci­ence, we could bet­ter de­sign the drugs.”

Dr. Chris­tian Hin­richs, as­sis­tant clin­i­cal in­ves­ti­ga­tor at the Cen­ter for Can­cer Re­search at the Na­tional Can­cer In­sti­tute, helped de­velop ad­vanced, cut­ting-edge pro­ce­dures to cure two women of a rare form of cer­vi­cal can­cer.

Source: Amer­i­can So­ci­ety of Clin­i­cal On­col­ogy

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