When the CDC’s top ad­vi­so­ry com­mit­tee met last week to re­view whether a hand­ful of very rare but po­ten­tial­ly fa­tal blood clots with low platelets might be linked to J&J’s Covid-19 vac­cine, the as­sump­tion was that the com­mit­tee would, at the very least, fol­low its own agen­da and vote on whether to wait for more da­ta, or make in­ter­im age- or risk-based rec­om­men­da­tions for the vac­cine.

In­stead, the com­mit­tee did nei­ther, punt­ing its vote un­til this Fri­day when it can hold a longer dis­cus­sion with the lat­est da­ta. None of the ACIP mem­bers raised ma­jor con­cerns with the de­ci­sion, or lack there­of, de­spite some calls to not pause the vac­cine in­def­i­nite­ly.

But the in­ac­tion al­so raised con­cerns about whether the CDC and FDA were shirk­ing their re­spon­si­bil­i­ties and un­nec­es­sar­i­ly de­lay­ing J&J vac­ci­na­tions as the race to slow the spread of the coro­n­avirus con­tin­ues.

In con­trast, the Eu­ro­pean Med­i­cines Agency’s safe­ty com­mit­tee quick­ly con­clud­ed its re­view of the blood clots and the J&J vac­cine on Tues­day, de­cid­ing the vac­cine’s ben­e­fits out­weigh the risks, while adding a warn­ing to the vac­cine’s la­bel, even as no one in Eu­rope has re­ceived the vac­cine yet. Fol­low­ing the com­mit­tee’s an­nounce­ment, J&J said it would re­sume ship­ments of the vac­cine.

At first blush, the EMA, which just went through a sim­i­lar re­view with As­traZeneca’s vac­cine and came to a sim­i­lar con­clu­sion, seems to have been the more proac­tive reg­u­la­tor. The EMA made a quick de­ci­sion on the avail­able da­ta and re-start­ed the process for get­ting more shots in­to arms.

But be­yond the head­line and fi­nal de­ci­sion lies a very dif­fer­ent sto­ry.

In the case of the CDC’s com­mit­tee, any mem­ber of the pub­lic (any­where in the world) could turn on a com­put­er and watch the pro­ceed­ings, lis­ten to the se­ri­ous­ness of the de­tails, hear the ar­gu­ments and see the slides that each of the com­mit­tee mem­bers re­view. The pub­lic even has an op­por­tu­ni­ty to weigh in at the CDC meet­ing, al­though it’s un­clear how those com­ments are ac­tu­al­ly used.

The ACIP de­ci­sion to de­lay ac­tion and wait for more da­ta on the blood clots may seem like an al­most neg­li­gent re­sponse, es­pe­cial­ly giv­en the EMA’s snap de­ci­sion, when time is of the essence. But the risk cal­cu­la­tions for the two re­gions are very dif­fer­ent. The US has more of the Pfiz­er and Mod­er­na Covid vac­cines than the EU to fill the gap left by the J&J pause. The US al­so has about 10 mil­lion dos­es of the J&J vac­cine wait­ing on shelves so if the FDA and CDC of­fer a green­light, those dos­es will im­me­di­ate­ly be ad­min­is­tered.

Al­so, the EMA’s safe­ty com­mit­tee com­plet­ed its analy­sis of the J&J and As­traZeneca vac­cine da­ta be­hind closed doors, on­ly of­fer­ing a peek in­to what oc­curred via lim­it­ed press re­leas­es and press con­fer­ences that usu­al­ly lead to as many new ques­tions as an­swers.

Pe­ter Ar­lett

For in­stance, at each of the EMA press con­fer­ences on the vac­cine la­bel up­dates, Pe­ter Ar­lett, the head of phar­ma­covig­i­lance at the EMA, has un­veiled new fig­ures on the cas­es of blood clots with low platelets for each of the vac­cines au­tho­rized in the EU.

But in do­ing so, Ar­lett fails to of­fer any fur­ther in­for­ma­tion on how many to­tal dos­es of the vac­cines have been ad­min­is­tered or where these new cas­es oc­curred. At least twice now, ei­ther Ar­lett or some­one else at the EMA has had to cor­rect or clar­i­fy what the num­bers mean, or where the cas­es did or did not oc­cur.

If the EMA is go­ing to re­lease these num­bers, why not put them in a press re­lease and ful­ly ex­plain them? In­stead, the agency leaves it to the pub­lic to de­cide on what they might mean, which is con­cern­ing as they are not ap­ples-to-ap­ples com­par­isons. Pfiz­er see­ing 25 cas­es of the blood clots and low platelets ver­sus J&J see­ing 8 cas­es are not com­pa­ra­ble con­sid­er­ing how many tens of mil­lions of more dos­es of the Pfiz­er vac­cine have been ad­min­is­tered.

In oth­er in­stances (e.g. re­leas­ing clin­i­cal tri­al re­sults), the EMA has tak­en a lead­ing role in show­ing the world how trans­paren­cy works. But in this case, even with the FDA and CDC tak­ing ex­tra days to make its de­ci­sion, and even if the de­ci­sion is to re­strict the use of the J&J vac­cine to a spe­cif­ic pop­u­la­tion, the im­por­tance of trans­paren­cy is clear.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.