Experts criticize new smoking calculus, call FDA’s pleasure quotient bad math

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WASHINGTON — Rarely has the con­cept of hap­pi­ness caused so much con­ster­na­tion in pub­lic health cir­cles.

Bur­ied deep in the fed­eral gov­ern­ment’s vo­lu­mi­nous new to­bacco reg­u­la­tions is a lit­tle-known cost-ben­e­fit cal­cu­la­tion that pub­lic health ex­perts see as po­ten­tially poi­son­ous: the hap­pi­ness quo­tient. It as­sumes that the ben­e­fits from re­duc­ing smok­ing — fewer early deaths and dis­eases of the lungs and heart — have to be dis­counted by 70 per­cent to off­set the loss in plea­sure that smok­ers ex­pe­ri­ence when they give up their habit.

Ex­perts say that cal­cu­la­tion wipes out most of the ben­e­fits from the reg­u­la­tions and could make them far more vul­ner­a­ble to le­gal chal­lenges from the to­bacco in­dus­try. And it could have a per­verse ef­fect, ex­perts said. The more suc­cess­ful reg­u­la­tors are at re­duc­ing smok­ing, the more it hurts them in the fi­nal eco­nomic ac­count­ing.

“This threat­ens the FDA’s abil­ity to take strong ac­tions against to­bacco,” Frank J. Cha­loupka, an econ­o­mist at the Univer­sity of Il­li­nois at Chi­cago, said of the Food and Drug Ad­min­is­tra­tion. “If they can’t demon­strate that there is a sig­nifi­cant eco­nomic ben­e­fit to do­ing it, then it makes their job much harder.”

On Wed­nes­day, Mr. Cha­loupka and other prom­i­nent econ­o­mists pub­licly took is­sue with the anal­y­sis. In a pa­per sub­mit­ted to the FDA as the pe­riod for pub­lic com­ment on the reg­u­la­tions neared its end Fri­day, the group said the hap­pi­ness quo­tient was way too high and should be changed be­fore the reg­u­la­tions take ef­fect. “There’s rea­son to be­lieve that num­ber is much too big,” said Jon­a­than Gruber, an econ­o­mist at the Mas­sa­chu­setts In­sti­tute of Tech­nol­ogy who was an au­thor of the pa­per. In his view, the agency’s anal­y­sis cited his past work er­ro­ne­ously.

The idea of lost hap­pi­ness is new for health reg­u­la­tion. But it has sur­faced as part of a long­stand­ing re­quire­ment — first cod­i­fied un­der for­mer Pres­i­dent Bill Clin­ton — that ev­ery set of fed­eral reg­u­la­tions with more than a $100 mil­lion ef­fect on the econ­omy needs an anal­y­sis to pre­vent the adop­tion of reg­u­la­tions with high costs and low ben­e­fits.

The cost-ben­e­fit anal­y­sis is em­bed­ded in a pro­posal from April that would ex­tend the FDA’s au­thor­ity, for the first time, to elec­tronic cig­a­rettes and other to­bacco prod­ucts such as ci­gars and pipe to­bacco — with po­ten­tially large con­se­quences for the mul­ti­bil­lion-dol­lar to­bacco in­dus­try.

The FDA re­leased a state­ment Wed­nes­day morn­ing de­tail­ing the eco­nom­ics be­hind its anal­y­sis, but the ex­pla­na­tion did not ad­dress the cen­tral as­ser­tion made by the econ­o­mists. An FDA spokes­woman said there is “still a great deal of un­cer­tainty” sur­round­ing the cal­cu­la­tion, and that the agency was help­ing to fund re­search to ex­plore the is­sue.

The spokes­woman em­pha­sized that the whole pur­pose of a pub­lic com­ment pe­riod was to get the best in­for­ma­tion for new reg­u­la­tions be­fore they be­came fi­nal. “Com­ments are en­cour­aged, and all will be con­sid­ered,” she said.

United States government - Bill Clinton - U.S. Food and Drug Administration - U.S. Department of Health and Human Services


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