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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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FDA re­view­ers head back to White Oak in 2023, with lead­er­ship look­ing to ap­pease a new Con­gress

Republicans have taken a stand against the pandemic era habit of lax work-from-home schedules. Now that they’ve wrestled control of the House majority, the FDA’s leadership is playing ball, sending many of the agency’s more than 18,000 employees back to their desks early next year.

Whether this exodus back to White Oak in Silver Spring, MD (many staff will still be allowed to work from home for multiple days per week) will mean more defections to industry and elsewhere remains to be seen.

Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.

Bro­ken promis­es? FDA needs more pow­er to re­move drugs from mar­ket­place, JA­MA analy­sis finds

The FDA is struggling to remove drugs from the marketplace that don’t show effectiveness in late stage trials, new JAMA analyses found, thanks to the persistent tension between speed and confidence in early clinical data.

Congress, regulated industry and patients have urged the FDA to shorten the amount of time that the market has to wait for drugs to become available that may help severe and prevalent diseases – and the FDA has listened, offering up a quick accelerated approval pathway that’s frequently used by new cancer drugs.