As Big Phar­ma los­es in­ter­est in new an­tibi­otics, in­fec­tions are on­ly grow­ing stronger

For­get Covid-19, mon­key­pox, and oth­er virus­es for the mo­ment and con­sid­er an­oth­er threat trou­bling in­fec­tious dis­ease spe­cial­ists: com­mon uri­nary tract in­fec­tions, or UTIs, that lead to emer­gency room vis­its and even hos­pi­tal­iza­tions be­cause of the fail­ure of oral an­tibi­otics.

There’s no Op­er­a­tion Warp Speed charg­ing to res­cue us from the germs that cause these in­fec­tions, which ex­pand­ed their range dur­ing the first year of the pan­dem­ic, ac­cord­ing to a new Cen­ters for Dis­ease Con­trol and Pre­ven­tion re­port. In the past year, the FDA de­clined to ap­prove two promis­ing oral drugs — su­lopen­em and tebipen­em — to treat drug-re­sis­tant UTIs, say­ing it need­ed more ev­i­dence they work as well as cur­rent drugs.

Sarah Do­ern­berg

In the mean­time, some UTI pa­tients “have to get ad­mit­ted and get an IV treat­ment for a blad­der in­fec­tion that typ­i­cal­ly would be treat­ed with oral an­tibi­otics,” said Sarah Do­ern­berg, an in­fec­tious dis­ease spe­cial­ist at the Uni­ver­si­ty of Cal­i­for­nia-San Fran­cis­co Med­ical Cen­ter.

Re­bec­ca Clausen, an of­fice work­er in Durham, North Car­oli­na, was pre­scribed sev­er­al cours­es of a cheap oral an­tibi­ot­ic for a per­sis­tent UTI ear­li­er this year, but it “just seemed to keep com­ing back,” she said. Doc­tors con­sid­ered a six-week treat­ment with an in­tra­venous drug, er­tapen­em, that would have cost her about $2,000 out-of-pock­et, but de­cid­ed it prob­a­bly wouldn’t help. For now, she’s sim­ply hop­ing the in­fec­tion won’t wors­en.

While spe­cial­ists say they are see­ing more uri­nary tract in­fec­tions that oral an­tibi­otics can’t elim­i­nate, the prob­lem is still thought to be rel­a­tive­ly rare (fed­er­al health of­fi­cials don’t di­rect­ly track the is­sue). How­ev­er, it’s em­blem­at­ic of a fail­ure in the an­tibi­otics in­dus­try that ex­perts and even US sen­a­tors say can be fixed on­ly with gov­ern­ment in­ter­ven­tion.

The CDC re­port, re­leased Ju­ly 12, showed that af­ter most­ly de­clin­ing dur­ing the pre­vi­ous decade, the in­ci­dence rates of sev­en dead­ly an­timi­cro­bial-re­sis­tant or­gan­isms surged by an av­er­age of 15% in hos­pi­tals in 2020 be­cause of overuse in Covid pa­tients. Some of the sharpest growth oc­curred in bugs that cause hard-to-treat UTIs.

Al­though near­ly 50,000 Amer­i­cans — and about 1.3 mil­lion peo­ple world­wide — die of re­sis­tant bac­te­r­i­al in­fec­tions each year, the FDA has not ap­proved a new an­tibi­ot­ic since 2019. Big Phar­ma has most­ly aban­doned an­tibi­otics de­vel­op­ment, and sev­en of the 12 com­pa­nies that suc­cess­ful­ly brought a drug to mar­ket in the past decade went bank­rupt or left the an­tibi­otics busi­ness be­cause of poor sales.

Sameer Kadri

That’s be­cause of a cen­tral para­dox: The more an an­tibi­ot­ic is ad­min­is­tered, the quick­er bac­te­ria will mu­tate to get around it. So prac­ti­tion­ers are ag­gres­sive­ly curb­ing use of the drugs, with 90% of US hos­pi­tals set­ting up stew­ard­ship pro­grams to lim­it the use of an­tibi­otics, in­clud­ing new ones. That, in turn, has caused in­vestors to lose in­ter­est in the an­tibi­otics in­dus­try.

A pipeline of new drugs is vi­tal, giv­en the im­placa­ble ca­pac­i­ty of bac­te­ria to mu­tate and adapt. But while re­sis­tance is an ever-present dan­ger, some 90%-95% of fa­tal in­fec­tions in­volve mi­crobes that are not mul­tidrug-re­sis­tant but dif­fi­cult to treat for oth­er rea­sons, such as the del­i­cate con­di­tion of the pa­tient, said Sameer Kadri, head of clin­i­cal epi­demi­ol­o­gy at the Na­tion­al In­sti­tutes of Health Clin­i­cal Cen­ter’s Crit­i­cal Care Med­i­cine De­part­ment.

Ja­son Gal­lagher

“As bad as an­tibi­ot­ic re­sis­tance is, it’s bad against a mi­nor­i­ty of peo­ple,” said Ja­son Gal­lagher, a pro­fes­sor and in­fec­tious dis­eases phar­ma­cist at Tem­ple Uni­ver­si­ty Hos­pi­tal in Philadel­phia. Since clin­i­cians usu­al­ly can’t quick­ly de­ter­mine a bug’s re­sis­tance lev­el, they start with the old drug most of the time. “That makes an­ti-in­fec­tives a pret­ty tough in­vest­ment from a drug com­pa­ny per­spec­tive,” he added. “You’re go­ing to de­vel­op your drug and peo­ple are go­ing to do their best to not use it.”

As an­tibi­otics com­pa­nies dis­ap­pear, so does their sci­en­tif­ic ex­per­tise, said David Shlaes, a re­tired phar­ma­ceu­ti­cal in­dus­try sci­en­tist. Should a par­tic­u­lar­ly dead­ly pat­tern of re­sis­tance de­vel­op with no drug pipeline, it could cause de­struc­tion on a hair-rais­ing scale, he said.

“An­tibi­otics are an es­sen­tial part of civ­i­liza­tion,” said Kevin Out­ter­son, a Boston Uni­ver­si­ty law pro­fes­sor who leads a pub­lic-pri­vate fund that helps com­pa­nies de­vel­op an­timi­cro­bials. “They must be re­newed every gen­er­a­tion or we will slip back in­to the pre-an­tibi­ot­ic era.”

The road­blocks to ap­proval of the UTI drugs tebipen­em and su­lopen­em il­lus­trate the com­plex­i­ty and reg­u­la­to­ry chal­lenges of the an­tibi­otics are­na.

In a big clin­i­cal tri­al com­plet­ed last year, Iterum Ther­a­peu­tics’ su­lopen­em was far bet­ter than an old­er drug, ciprofloxacin, at re­duc­ing UTI symp­toms, but it didn’t seem as adept at killing bac­te­ria, which the FDA con­sid­ered to be an equal­ly im­por­tant mea­sure of suc­cess. At a June 3 work­shop, FDA of­fi­cials in­di­cat­ed they might be will­ing to change their stan­dard in fu­ture tri­als.

An­oth­er com­pa­ny, Spero Ther­a­peu­tics, pub­lished what looked like a suc­cess­ful tri­al for oral tebipen­em in the New Eng­land Jour­nal of Med­i­cine in April. But FDA of­fi­cials re­ject­ed Spero’s ap­pli­ca­tion for li­cen­sure be­cause a species of bac­te­ria in­clud­ed in the analy­sis was deemed ir­rel­e­vant to the drug’s ef­fi­ca­cy.

A Life­line for Pa­tients

Though new oral drugs against UTIs are sore­ly need­ed, IV drugs can still con­quer most rou­tine UTIs. But the broad­er threat of a fu­ture with­out new an­tibi­otics is par­tic­u­lar­ly fright­en­ing to pa­tients with se­ri­ous chron­ic dis­eases, who are per­ma­nent­ly en­gaged in strug­gles with bac­te­ria.

Two or three times a day, Mol­ly Pam, a 33-year-old chef and pa­tient ad­vo­cate in San Fran­cis­co, in­hales neb­u­lized blasts of col­istin or aztre­on­am. These are an­tibi­otics that the typ­i­cal per­son stays away from, but for the 30,000 US cys­tic fi­bro­sis pa­tients like Pam, dead­ly bugs and pow­er­ful drugs are a fix­ture of life.

Sev­er­al times a year, when fever or ex­haus­tion sig­nals that the bugs col­o­niz­ing her dam­aged, mu­cus-clogged lungs are get­ting over­ly pro­cre­ative, Pam heads to a clin­ic or hos­pi­tal for IV treat­ment. In 2019, just as she was ap­proach­ing re­sis­tance to all an­tibi­otics, the drug Zer­baxa re­ceived FDA ap­proval.

Pseudomonas and MR­SA bac­te­ria have col­o­nized Pam’s lungs since she was a child, their mu­ta­tions re­quir­ing fre­quent an­tibi­ot­ic up­dates. In 2018, she was struck down with a drug-re­sis­tant, tu­ber­cu­lo­sis-like bac­te­ria that re­quired a year of three-times-a-day IV drug treat­ments on top of her oth­er drugs. Last year, she was air­lift­ed to Stan­ford Med­ical Cen­ter af­ter she be­gan cough­ing up blood from a dam­aged lung.

Doc­tors test Pam’s spu­tum four times a year to de­ter­mine which bugs she’s har­bor­ing and which an­tibi­otics will work against them. She’s al­ways on­ly a few mu­ta­tions from dis­as­ter.

“I ab­solute­ly de­pend on new drugs,” Pam said.

Steer­ing Stew­ard­ship Pro­grams

The de­vel­op­ment and test­ing of these new mol­e­cules is hard­scrab­ble ter­rain, fea­tur­ing fre­quent con­flicts be­tween the FDA and in­dus­try over how to mea­sure an an­tibi­ot­ic’s ef­fec­tive­ness — is it pa­tient sur­vival? Symp­tom im­prove­ment? Bac­te­ria count? And over how long a pe­ri­od?

Mean­while, Con­gress has aid­ed the in­dus­try with patent ex­ten­sions, and fed­er­al agen­cies have poured in hun­dreds of mil­lions in grants and part­ner­ships. The World Health Or­ga­ni­za­tion and the drug in­dus­try in 2020 cre­at­ed a $1 bil­lion ven­ture cap­i­tal fund to sup­port wor­thy an­tibi­otics com­pa­nies.

Still, stew­ard­ship of an­tibi­otics ar­guably has had the biggest in­flu­ence in re­duc­ing the threat of re­sis­tance. A 2019 CDC re­port found an 18% re­duc­tion since 2013 in deaths caused by drug-re­sis­tant or­gan­isms, and a 21% de­cline in in­fec­tions of MR­SA, or me­thi­cillin-re­sis­tant Staphy­lo­coc­cus au­reus, once a lead­ing med­ical bo­gey­man.

But progress can make it hard­er to test new drugs. With high­ly re­sis­tant bac­te­r­i­al in­fec­tions still rel­a­tive­ly un­usu­al, clin­i­cal tri­als for new drugs gen­er­al­ly mea­sure their ef­fec­tive­ness against all bac­te­ria in the rel­e­vant class, rather than the most re­sis­tant bugs.

Emi­ly Spi­vak

And since new drugs of­ten gain ap­proval sim­ply by show­ing they are rough­ly as ef­fec­tive as ex­ist­ing drugs, in­fec­tious dis­ease doc­tors gen­er­al­ly shun them, at least ini­tial­ly, skep­ti­cal of their rel­a­tive­ly high prices and ques­tion­able su­pe­ri­or­i­ty.

“There aren’t that many peo­ple with an­tibi­ot­ic re­sis­tance,” said Emi­ly Spi­vak, who leads stew­ard­ship pro­grams at the Uni­ver­si­ty of Utah and VA Salt Lake City hos­pi­tals. “When peo­ple get these in­fec­tions, it’s hor­ri­ble. But there aren’t enough to make the kind of prof­its the com­pa­nies want.”

For ex­am­ple, hos­pi­tal­ized pa­tients with MR­SA-re­lat­ed pneu­mo­nia of­ten can be treat­ed with van­comycin (start­ing at about $15 per day), said Spi­vak, who chairs the In­fec­tious Dis­eases So­ci­ety of Amer­i­ca’s an­timi­cro­bial re­sis­tance com­mit­tee. She some­times turns to a new­er al­ter­na­tive, cef­taro­line ($400 a day), which can have few­er side ef­fects. “But even so, we are not crank­ing through these drugs, and we nev­er will, be­cause luck­i­ly we can do oth­er things to pre­vent MR­SA, such as clean­ing skin be­fore surgery and keep­ing catheters clean.”

Time for ‘Warp Speed’?

In the ear­ly days of Covid, many hos­pi­tals des­per­ate­ly threw an­timi­cro­bials at the mys­te­ri­ous virus, and the pan­dem­ic cri­sis strained stew­ard­ship teams, Spi­vak said. The new CDC da­ta showed that clin­i­cians gave an­tibi­otics to 80% of hos­pi­tal­ized Covid pa­tients in the first eight months of the pan­dem­ic, al­though such drugs have no im­pact on Covid in­fec­tion.

But the up­take of new an­tibi­otics has been slow. A re­port on 17 new an­tibi­otics mar­ket­ed in the Unit­ed States over the past five years showed on­ly three with sales over $100 mil­lion per year. The 17 av­er­aged sales of about $44 mil­lion for the 12 months end­ing in June 2020.

A few of the new drugs, such as a com­bi­na­tion an­tibi­ot­ic mar­ket­ed in the US as Avy­caz, have grad­u­al­ly re­placed col­istin, a high­ly tox­ic 1950s com­pound that was brought back in 2000 be­cause of its ef­fi­ca­cy against cer­tain re­sis­tant bac­te­ria.

Do­minic Chan

Yet even that tran­si­tion, rec­om­mend­ed by in­fec­tious dis­ease spe­cial­ists, was grad­ual. That’s not sur­pris­ing since col­istin costs about $140 for a 10-day treat­ment, while a course of Avy­caz might set a hos­pi­tal back $14,000 to $28,000, not­ed Do­minic Chan, chief of phar­ma­cy ser­vices at Lega­cy Health in Ore­gon.

Medicare re­im­burse­ment for treat­ing hos­pi­tal in­fec­tions is low, Chan said, “so there’s no in­cen­tive for the hos­pi­tals to in­vest that type of cap­i­tal in­to bring­ing these agents in — oth­er than do­ing the right thing.”

In most cas­es, hos­pi­tals do ap­pear to be do­ing the right thing, how­ev­er. Re­cent CDC da­ta shows that 90% of US hos­pi­tals have stopped us­ing col­istin, said agency spokesper­son Martha Sha­ran.

Ex­ec­u­tives from the dwin­dling num­ber of an­tibi­otics mak­ers com­plain that stew­ard­ship pro­grams are too stingy, to the detri­ment of pa­tients. In part, they blame Medicare pro­grams that pay hos­pi­tals a lump sum for treat­ment of a giv­en con­di­tion. A con­gres­sion­al bill filed in 2019 and re­sub­mit­ted last year would re­quire Medicare to pay for new an­tibi­otics sep­a­rate­ly. De­moc­rats blocked the bill, but an­tibi­otics pro­duc­ers ar­gue it would in­cen­tivize hos­pi­tals to use their drugs.

Ted Schroed­er

Hold­ing back on the new an­tibi­otics al­lows re­sis­tance to old drugs to grow worse, and “that makes it hard­er and hard­er for a new an­tibi­ot­ic to do its job,” said Ted Schroed­er, CEO of an­tibi­otics mak­er Nabri­va and leader of an in­dus­try in­ter­est group.

But the bot­tom line is that most pa­tients don’t need the newest drugs, Kadri said.

In a 2020 NIH study that the FDA helped fund, Kadri and his col­leagues re­viewed records from 134 hos­pi­tals from 2009 to 2015 to find ex­am­ples of dif­fi­cult-to-treat, high­ly re­sis­tant bac­te­ria of the gram-neg­a­tive type — a key area of con­cern. Of about 139,000 gram-neg­a­tive in­fec­tions, on­ly 1,352 fell in­to the dif­fi­cult-to-treat cat­e­go­ry — rough­ly 1%.

“There are just not enough cas­es” to cre­ate an ad­e­quate mar­ket for new an­tibi­otics, Kadri said.

Ex­trap­o­lat­ing from the study, the mar­ket for new an­tibi­otics against high­ly re­sis­tant gram-neg­a­tive bac­te­ria would range from $120 mil­lion to $430 mil­lion a year, com­pared with the av­er­age $1 bil­lion need­ed to de­vel­op a sin­gle drug, wrote Neil Clan­cy and Minh-Hong Nguyen of the Vet­er­ans Af­fairs Pitts­burgh Health­care Sys­tem.

In the ab­sence of a vi­able mar­ket, in­fec­tious dis­ease ex­perts, drug com­pa­nies, and pa­tient groups have ral­lied be­hind the PAS­TEUR Act, in­tro­duced by Sens. Michael Ben­net (D-Co­lo.) and Todd Young (R-Ind.) last year. The bill would cre­ate a fund of up to $11 bil­lion over 10 years to award promis­ing an­timi­cro­bials that were close to or had re­ceived FDA ap­proval. The gov­ern­ment would guar­an­tee pay­ments of up to $3 bil­lion for each drug, re­mov­ing the in­cen­tive for overuse.

PAS­TEUR has 40 co-spon­sors in the Sen­ate. Ex­perts think its pas­sage is cru­cial.

“Even though, on a pop­u­la­tion ba­sis, the need for new drugs is small, you don’t want to be that pa­tient” who might need them, Kadri said. “If you are, you want to have an ar­ray of drugs that are safe and ef­fec­tive.”

By Arthur Allen

First pub­lished at KHN (Kaiser Health News) — a non­prof­it news ser­vice cov­er­ing health is­sues. It is an ed­i­to­ri­al­ly in­de­pen­dent pro­gram of KFF (Kaiser Fam­i­ly Foun­da­tion), which is not af­fil­i­at­ed with Kaiser Per­ma­nente.

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