Is Paxlovid, the Covid pill, reach­ing those who most need it? The gov­ern­ment won’t say

As the na­tion large­ly aban­dons mask man­dates, phys­i­cal dis­tanc­ing, and oth­er covid-19 pre­ven­tion strate­gies, elect­ed of­fi­cials and health de­part­ments alike are now cham­pi­oning an­tivi­ral pills. But the fed­er­al gov­ern­ment isn’t say­ing how many peo­ple have re­ceived these po­ten­tial­ly life­sav­ing drugs or whether they’re be­ing dis­trib­uted eq­ui­tably.

Pfiz­er’s Paxlovid pill, along with Mer­ck’s mol­nupi­ravir, are aimed at pre­vent­ing vul­ner­a­ble pa­tients with mild or mod­er­ate covid from be­com­ing sick­er or dy­ing. More than 300 Amer­i­cans still die from covid every day.

Na­tion­al sup­ply counts, which the Biden ad­min­is­tra­tion has shared spo­rad­i­cal­ly, aren’t the on­ly da­ta lo­cal health of­fi­cials need to en­sure their res­i­dents can ac­cess the treat­ments. Re­cent fed­er­al changes de­signed to let large phar­ma­cy chains like CVS and Wal­greens ef­fi­cient­ly man­age their sup­plies have had an un­in­tend­ed con­se­quence: Now many pub­lic health work­ers are un­able to see how many dos­es have been shipped to their com­mu­ni­ties or used. And they can’t tell whether the most vul­ner­a­ble res­i­dents are fill­ing pre­scrip­tions as of­ten as their wealth­i­er neigh­bors.

KHN has re­peat­ed­ly asked Health and Hu­man Ser­vices of­fi­cials to share more de­tailed covid ther­a­peu­tic da­ta and to ex­plain how it cal­cu­lates uti­liza­tion rates, but they have not shared even the to­tal num­ber of peo­ple who have got­ten Paxlovid.

So far, the most de­tailed ac­count­ing has come from the drug­mak­ers them­selves. Pfiz­er CEO Al­bert Bourla re­port­ed on a re­cent earn­ings call that an es­ti­mat­ed 79,000 peo­ple re­ceived Paxlovid dur­ing the week that end­ed April 22, up from 8,000 a week two months ear­li­er.

Un­like covid vac­ci­na­tions or cas­es, HHS doesn’t track the race, eth­nic­i­ty, age, or neigh­bor­hood of peo­ple get­ting treat­ments. Vac­ci­na­tion num­bers, ini­tial­ly pub­lished by a hand­ful of states, al­lowed KHN to re­veal stark racial dis­par­i­ties just weeks in­to the roll­out. Fed­er­al da­ta showed that Black, Na­tive, and His­pan­ic Amer­i­cans have died at high­er rates than non-His­pan­ic white Amer­i­cans.

Los An­ge­les Coun­ty’s De­part­ment of Pub­lic Health has worked to en­sure its 10 mil­lion res­i­dents, es­pe­cial­ly the most vul­ner­a­ble, have ac­cess to treat­ment. When Paxlovid sup­ply was lim­it­ed in the win­ter, of­fi­cials there made sure that phar­ma­cies in hard-hit com­mu­ni­ties were well stocked, ac­cord­ing to Seira Kuri­an, a re­gion­al health of­fi­cer in the de­part­ment. In April, the coun­ty launched its own tele­health ser­vice to as­sess res­i­dents for treat­ment free of charge, a mod­el that avoids many of the hur­dles that make treat­ment at for-prof­it phar­ma­cy-based clin­ics dif­fi­cult for unin­sured, rur­al, or dis­abled pa­tients to use.

But with­out fed­er­al da­ta, they don’t know how many coun­ty res­i­dents have got­ten the pills.

Re­al-time da­ta would show whether a neigh­bor­hood is fill­ing pre­scrip­tions as ex­pect­ed dur­ing a surge, or which com­mu­ni­ties pub­lic health work­ers should tar­get for ed­u­ca­tion­al cam­paigns. With­out ac­cess to the fed­er­al sys­tems, Los An­ge­les Coun­ty, which serves more res­i­dents than the health de­part­ments of 40 en­tire states, has to use the lim­it­ed pub­lic in­ven­to­ry da­ta that HHS pub­lish­es.

That dataset con­tains on­ly a slice of in­for­ma­tion and in some cas­es shows months-old in­for­ma­tion. And be­cause the da­ta ex­cludes cer­tain types of providers, such as nurs­ing homes and Vet­er­ans Health Ad­min­is­tra­tion fa­cil­i­ties, coun­ty of­fi­cials can’t tell if pa­tients there have tak­en the pills.

Be­cause so lit­tle da­ta is avail­able, Kuri­an’s team cre­at­ed its own sur­vey, ask­ing providers to re­port the ZIP codes of pa­tients who have re­ceived the covid ther­a­pies. With the sur­vey, it’s now eas­i­er to fig­ure out which phar­ma­cies and clin­ics need more sup­plies.

But not every­one com­pletes it, she said: “Of­ten­times, we have to still do some guessti­mat­ing.”

In At­lanta, staff at Good Samar­i­tan Health Cen­ter would use de­tailed in­for­ma­tion to di­rect low-in­come pa­tients to phar­ma­cies with Paxlovid. Though the drug wasn’t read­i­ly avail­able dur­ing the first omi­cron surge, the next one will be “a new fron­tier,” said Bre­an­na Lath­rop, the cen­ter’s chief op­er­at­ing of­fi­cer.

Ide­al­ly, she said, her staff would be able to see “every­thing you need to know in one spot” — in­clud­ing which phar­ma­cies have the pills in stock, when they’re open, and whether they of­fer home de­liv­ery. Stu­dent vol­un­teers built the cen­ter a sim­i­lar data­base for covid test­ing ear­li­er in the pan­dem­ic.

Paxlovid and mol­nupi­ravir be­came avail­able in the U.S. in late De­cem­ber. They have quick­ly be­come the go-to treat­ments for non-hos­pi­tal­ized pa­tients, re­plac­ing near­ly all the mon­o­clon­al an­ti­body in­fu­sions, which are less ef­fec­tive against cur­rent covid strains.

Though the gov­ern­ment doesn’t record Paxlovid use by race and eth­nic­i­ty, re­searchers tracked those trends for the first-gen­er­a­tion in­fu­sions.

Amy Fee­han, co-au­thor of a CDC-fund­ed study and a clin­i­cal re­search sci­en­tist at Ochsner Health in Louisiana, found that Black and His­pan­ic pa­tients with covid were sig­nif­i­cant­ly less like­ly than white and non-His­pan­ic pa­tients to re­ceive those ini­tial out­pa­tient treat­ments. Oth­er re­searchers found that lan­guage dif­fi­cul­ties, lack of trans­porta­tion, and not know­ing the treat­ments ex­ist­ed all con­tributed to the dis­par­i­ties. Fee­han’s study, us­ing da­ta from 41 med­ical sys­tems, found no large dis­crep­an­cies for hos­pi­tal­ized pa­tients, who didn’t have to seek out the drugs them­selves.

Pa­tients at At­lanta’s Good Samar­i­tan Health Cen­ter of­ten don’t know that if they get test­ed quick­ly they can re­ceive treat­ment, Lath­rop said. Some as­sume they don’t qual­i­fy or can’t af­ford it. Oth­ers won­der if the pills work or are safe. There are “just a lot of ques­tions in peo­ple's minds,” Lath­rop said, about whether “it ben­e­fits them.”

When Jef­frey Klaus­ner was a deputy of­fi­cer at the San Fran­cis­co De­part­ment of Pub­lic Health, “our first pri­or­i­ty was trans­paren­cy and da­ta shar­ing,” he said. “It's im­por­tant to build trust, and to en­gage with the com­mu­ni­ty.” Now a pro­fes­sor at the Uni­ver­si­ty of South­ern Cal­i­for­nia, he said fed­er­al and state of­fi­cials should share the da­ta they have and al­so col­lect de­tailed in­for­ma­tion about pa­tients re­ceiv­ing treat­ment — race, eth­nic­i­ty, age, ill­ness sever­i­ty — so that they can cor­rect for any in­equities.

Pub­lic health of­fi­cials and re­searchers who spoke with KHN said that HHS of­fi­cials may not think the da­ta is ac­cu­rate or have ad­e­quate staff to an­a­lyze it. The head of HHS’ ther­a­peu­tics dis­tri­b­u­tion ef­fort, Dr. Derek Eis­nor, sug­gest­ed as much dur­ing an April 27 meet­ing with state and lo­cal health of­fi­cials. One lo­cal of­fi­cial asked the fed­er­al agency to share lo­cal num­bers so they could in­crease out­reach in com­mu­ni­ties with low us­age. Eis­nor re­spond­ed that be­cause HHS doesn’t re­quire providers to say how much they use, the re­port­ing “is kind of mediocre at best,” adding that he didn’t think it was his agency’s role to share that in­for­ma­tion.

Eis­nor al­so said that state health de­part­ments should now be able to see lo­cal or­ders and us­age from phar­ma­cy chains like CVS, and that the agency hopes to soon re­lease week­ly na­tion­al da­ta on­line. But coun­ties like Los An­ge­les — which has re­quest­ed ac­cess to the fed­er­al sys­tems with no suc­cess — still don’t have ac­cess to the da­ta they need to fo­cus out­reach ef­forts or spot emerg­ing dis­par­i­ties.

Spokesper­son Tim Granholm said that HHS is look­ing in­to ways to share ad­di­tion­al da­ta with the pub­lic.

Record­ings of the week­ly meet­ings, in which HHS of­fi­cials share up­dates about dis­tri­b­u­tion plans and an­swer ques­tions from pub­lic health work­ers, phar­ma­cists, and clin­i­cians, were post­ed on­line un­til March. HHS’ me­dia of­fice has since re­peat­ed­ly de­clined to grant KHN ac­cess, say­ing “the record­ings are not open to press.” That’s be­cause HHS wants to en­cour­age open con­ver­sa­tion dur­ing the meet­ings, ac­cord­ing to Granholm. He did not say what le­gal au­thor­i­ty al­lows the de­part­ment to bar me­dia from the pub­lic meet­ings. KHN ob­tained the pub­lic records through Free­dom of In­for­ma­tion Act re­quests.

A se­nior White House of­fi­cial said that the Biden ad­min­is­tra­tion is at­tempt­ing to col­lect ac­cu­rate da­ta on how many peo­ple re­ceive Paxlovid and oth­er treat­ments but said it doesn’t de­fine suc­cess by how many peo­ple do so. Its fo­cus, the of­fi­cial said, is on mak­ing sure the pub­lic knows treat­ments are avail­able and that doc­tors and oth­er providers un­der­stand which pa­tients are el­i­gi­ble for them.

We still need to know where the pills are go­ing, Fee­han said. “We need that da­ta as soon as hu­man­ly pos­si­ble.”

Un­til then, Los An­ge­les Coun­ty’s Kuri­an and her peers will keep “guessti­mat­ing” where res­i­dents need more help. “If some­one can just give us a re­port that has that in­for­ma­tion,” she said, “of course, that makes it eas­i­er.”

By Han­nah Recht

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.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Phil Sharp, Nobel Prize laureate (L), and John Carroll, Endpoints News co-CEO (via Michael Last)

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

On Thursday evening in Boston I had the great good fortune to talk about the creation of the biotech industry with Nobel Prize-winning scientist Phil Sharp. I learned quite a bit about the early days of Genentech, Biogen and Alnylam, which all helped birth this unusual drug development ecosystem. And that’s why we can do things like the Endpoints 11. Here’s my talk with Phil Sharp, which you can either watch or read below.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Petro Terblanche, Afrigen Biologics managing director (Kristin Palitza/picture-alliance/dpa/AP Images)

WHO-backed Afrigen plans a charge to­ward the clin­ic with Africa's first Covid-19 vac­cine

NEW YORK — When vaccines from high-income countries did not arrive in Africa, a local WHO-backed company decided to take the matter into its own hands.

The South Africa-based company Afrigen Biologics and Vaccines has developed the continent’s first mRNA Covid-19 vaccine that will enter clinical trials in early 2023. Afrigen developed the shot by copying publicly available sequencing information about Moderna’s shot after the biotech and Pfizer refused assistance.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

Covid-19 roundup: Mod­er­na sends in EUA for bi­va­lent teen boost­er; US trim­ming Pfiz­er/BioN­Tech do­na­tions

Though Moderna’s bivalent vaccine to counter the Omicron variant has cleared the initial hurdles in getting FDA authorization, the vaccine maker is moving on to the next step.

On Twitter, the company announced on Friday that it has filed a EUA for its bivalent vaccine for use in adolescents aged 12 through 17 and for smaller children aged six through 11.