Opin­ion: Con­gress needs to take a hard look at what went on at Trump's White House dur­ing the pan­dem­ic

Masks are com­ing off, restau­rants are fill­ing up again in­doors, and the US is, by all ac­counts, re­turn­ing to some sort of nor­mal-ish state.

But as the Covid-19 death toll slow­ly ticks up to the 600,000 mark, there’s a grow­ing con­sen­sus that at least some of those lives could’ve been saved. Where and how the past ad­min­is­tra­tion went wrong is easy to di­ag­nose as an arm­chair ex­pert, but Con­gress needs to be­gin what will like­ly be a gar­gan­tu­an and long process of ac­tu­al­ly sift­ing through the da­ta, in­ter­nal emails and de­ci­sion mak­ing to see what ex­act­ly hap­pened and what needs to be cor­rect­ed mov­ing for­ward.

With the help of the Free­dom of In­for­ma­tion Act, the pub­lic can now see a tiny glimpse of what some of the top health of­fi­cials in the Trump ad­min­is­tra­tion were do­ing at the height of the pan­dem­ic, and it isn’t pret­ty.

First and fore­most, the emails show how for­mer FDA com­mis­sion­er Steve Hahn lied to the pub­lic when he apol­o­gized for mis­s­peak­ing dur­ing a press con­fer­ence about how con­va­les­cent plas­ma would in­crease sur­vival. He didn’t mis­s­peak, his email shows he was plan­ning to note the 35% over­all in­crease in sur­vival all along.

And rather than of­fer­ing sup­port for what must’ve been a gru­el­ing sev­er­al months at the be­gin­ning of 2020 for those top ad­vi­sors like Deb­o­rah Birx and Hahn, se­nior Trump ap­pointees like Hope Hicks and Joe Gro­gan were in­stead push­ing their own agen­das, seek­ing fa­vors and mak­ing per­son­al ap­peals and de­mands — of­ten times for drugs like hy­drox­y­chloro­quine, which proved to be com­plete­ly in­ef­fec­tive.

And why was Katie Miller, the for­mer com­mu­ni­ca­tions di­rec­tor for Vice Pres­i­dent Mike Pence with no pub­lic health or med­ical ex­pe­ri­ence, telling Hahn what to look in­to ther­a­peu­tic-wise in April 2020?

Emails from a month pri­or to the Miller de­mand al­so show how celebri­ties with ac­cess to the top of­fi­cials (like Dr. Oz and Lau­ra In­gra­ham) were not on­ly grant­ed an au­di­ence but al­so mak­ing de­mands on how to run tri­als for hy­drox­y­chloro­quine.

Aaron Kessel­heim

And this is just the tini­est sliv­er of the ice­berg that Con­gress needs to look in­to and re­lease pub­licly, not on­ly for those who died of Covid-19 and their fam­i­lies, but for the next ad­min­is­tra­tion that has to deal with a sim­i­lar­ly mas­sive, time-sen­si­tive is­sue like this.

Tax­pay­er dol­lars shouldn’t be wast­ed on what celebri­ties think, par­tic­u­lar­ly dur­ing a pan­dem­ic.

Aaron Kessel­heim, pro­fes­sor of med­i­cine at Har­vard Med­ical School, put it best when he told me re­cent­ly, “I was most hor­ri­fied by the at­tempts by mem­bers of the Trump ad­min­is­tra­tion/Con­gress and celebri­ties to get fa­vors or make per­son­al ap­peals to the FDA Com­mis­sion­er, and to see such mi­nor, use­less stuff be el­e­vat­ed up to the high­est lev­els of the FDA.

“If com­mu­ni­ca­tions like this were more rou­tine­ly made pub­licly avail­able, then maybe such folks would feel less en­ti­tled to make them, and all of the peo­ple who re­ly on the FDA would bet­ter trust that cer­tain de­ci­sions were be­ing made on sci­en­tif­ic terms rather than po­lit­i­cal (or Dr. Oz’s!) in­ter­fer­ence,” he added.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

FDA un­veils new draft guid­ance to help with oligonu­cleotide ther­a­peu­tics de­vel­op­ment

While oligonucleotides, a wide variety of synthetically modified RNA or RNA/DNA hybrids that bind to a target RNA sequence to alter RNA and/or protein expression, have been winning approvals in recent years (e.g. Novartis’ cholesterol drug Leqvio), the regulatory agency is offering new draft guidance for those looking to follow a similar path.

The non-binding guidance, titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry” deals with pharmacokinetic, pharmacodynamic, and safety assessments required as part of oligonucleotide therapeutics R&D.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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