FDA ab­sent from Trump opi­oid panel

Modern Healthcare - - NEWS - By Steven Ross John­son

Ex­perts fo­cused on find­ing ways to curb the num­ber of over­doses in the U.S. say there’s one very im­por­tant per­son miss­ing from Pres­i­dent Don­ald Trump’s com­mis­sion—any rep­re­sen­ta­tive from the fed­eral agency reg­u­lat­ing pre­scrip­tion drugs.

“There’s quite a bit the Food and Drug Ad­min­is­tra­tion could be do­ing and hasn’t done,” said Dr. An­drew Kolodny, co-di­rec­tor of opi­oid pol­icy re­search at Bran­deis Univer­sity, re­fer­ring to stricter fed­eral reg­u­la­tion of pre­scrip­tion painkillers, which physi­cians have of­ten used to treat com­mon chronic con­di­tions such as back pain and fi­bromyal­gia.

Trump last week in­tro­duced a high­pro­file group that is tasked with re­port­ing on ideas and progress to­ward curb­ing the num­ber of peo­ple who die from drug over­doses every year. The com­mis­sion in­cludes New Jersey Gov. Chris Christie—who has led sev­eral statewide ef­forts to ad­dress heroin ad­dic­tion—U.S. At­tor­ney Gen­eral Jeff Ses­sions, De­fense Sec­re­tary James Mat­tis and HHS Sec­re­tary Tom Price.

But Kolodny and other ad­dic­tion ex­perts say the FDA could help tighten reg­u­la­tions over drug­mak­ers, os­ten­si­bly stem­ming the tide and in­ten­sity of prod­ucts that the Cen­ters for Dis­ease Con­trol and Pre­ven­tion has iden­ti­fied as hav­ing heav­ily con­trib­uted to the over­dose epi­demic. Af­ter years of heavy crit­i­cism by pa­tient ad­vo­cacy groups, pre­scrip­tion painkillers now carry stronger warn­ing la­bels and un­dergo a more strin­gent re­view.

Kolodny says those are good first steps, but he wonders whether Trump’s nom­i­nee to head the FDA, Dr. Scott Got­tlieb, can make greater in­roads given his deep ties to the phar­ma­ceu­ti­cal in­dus­try. Got­tlieb serves on the boards of three drug com­pa­nies and his ven­ture cap­i­tal firm funds 150 oth­ers. If he’s con­firmed, Got­tlieb must step down from those boards and sell any shares in those com­pa­nies. He has said he will re­cuse him­self from any de­ci­sions that might re­sult in the ap­per­aance of a con­flict of in­ter­est.

Kolodny isn’t so sure Got­tlieb is the right per­son to lead the FDA’s anti-opi­oid abuse ef­forts. “I’m wor­ried that we’ll con­tinue to see FDA poli­cies that are 20 years old that re­ally al­low opi­oid mak­ers to con­tinue to pour fuel on a fire.”

The FDA long has been ac­cused of ex­pe­dit­ing the ap­proval of highly ad­dic­tive opi­oid-based pain killers. One of the most no­table ex­am­ples oc­curred in 2013, af­ter the FDA ap­proved the drug Zo­hy­dro, the first ex­tended-re­lease pure form of hy­drocodone. It was ap­proved with­out tam­per-re­sis­tant pro­tec­tions, so it could be eas­ily crushed to max­i­mize po­tency. In ap­prov­ing the drug, the FDA ig­nored the rec­om­men­da­tions of its own ad­vi­sory panel, which voted 11-2 to re­ject it.

At the time, pub­lic health of­fi­cials called for then-FDA Com­mis­sioner Dr. Mar­garet Ham­burg to step down. She ar­gued the painkiller would help pa­tients with chronic pain not re­lated to can­cer—the same ar­gu­ment pub­lic health ex­perts say led physi­cians to over­pre­scribe the drugs.

Scru­tiny con­tin­ued even af­ter Ham­burg left her FDA post in 2015. Her suc­ces­sor, Dr. Robert Califf, a for­mer med­i­cal re­searcher, was also ac­cused of go­ing easy on drug­mak­ers be­cause of his past work with them. In re­sponse to the crit­i­cism, Califf an­nounced just prior to his confirmation that the FDA would re-eval­u­ate its ap­proach in re­view­ing opi­oid pain re­liev­ers. He pledged the agency would add new warn­ing la­bels to the most com­monly pre­scribed opi­oids and re­quire new opi­oid drugs to go be­fore an out­side panel of in­de­pen­dent re­view­ers.

But a num­ber of sen­a­tors, say­ing the moves were too lit­tle, too late, placed a hold on Califf’s nom­i­na­tion. Sen. Joe Manchin, a Demo­crat from West Vir­ginia, said he was not im­pressed by the plans and wanted the FDA to “get se­ri­ous about the dan­gers of pre­scrip­tion drugs.”

“The FDA is part of the opi­oid prob­lem when Amer­ica is de­pend­ing on it to be part of the so­lu­tion,” Sen. Ed­ward Markey (D-Mass.) said at a Fe­bru­ary 2016 news con­fer­ence.

The ab­sence of any FDA of­fi­cial from Trump’s com­mis­sion does not mean that the agency’s role and suc­cess in the bat­tle against over­doses will not be as­sessed. The com­mis­sion is to de­liver “in­terim rec­om­men­da­tions” in the next 90 days on how the fed­eral gov­ern­ment can ad­dress ad­dic­tion and how to prop­erly fund treat­ment and pre­ven­tion ef­forts and iden­tify un­der­served ar­eas. A fi­nal re­port is due in Oc­to­ber.

“I think it’s a great idea that th­ese are a group of lead­ers that have the author­ity to act,” said Anne Wood­bury, ex­ec­u­tive di­rec­tor of Ad­vo­cates for Opi­oid Re­cov­ery, about the com­mis­sion. She added that the pres­i­dent is mak­ing prom­ises to quickly de­liver re­sults and is putting a lot of his po­lit­i­cal cap­i­tal and rep­u­ta­tion be­hind the ef­fort.

Oth­ers say the com­mis­sion is a step back from the more force­ful and ac­tion-driven lan­guage Trump used dur­ing the cam­paign. “It’s time for us to go be­yond the rhetoric,” said Dr. Leana Wen, health com­mis­sioner for the city of Bal­ti­more. She says the sever­ity of the epi­demic calls for proven, ev­i­dence­based strate­gies and money to fund those so­lu­tions.

“There’s quite a bit the Food and Drug Ad­min­is­tra­tion could be do­ing and hasn’t done.” DR. AN­DREW KOLODNY Co-di­rec­tor of opi­oid pol­icy re­search Bran­deis Univer­sity

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