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FDA’s Unfortunate Ruling about Vaccine Monitoring

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COMMENT: With all of the alarm­ing dis­in­for­ma­tion being dis­sem­i­nat­ed about microchips being intro­duced into unsus­pect­ing sub­jects via vac­cines, we can’t stress strong­ly enough that we are NOT “anti-vaxxers.”

When prop­er­ly man­u­fac­tured and vet­ted, vac­cines are fun­da­men­tal to the main­te­nance of pub­lic health.

Nonethe­less, there have been instances where improp­er­ly vet­ted vac­cines have caused dev­as­tat­ing health effects, such as the ini­tial polio vac­cine. Con­t­a­m­i­na­tion of that vac­cine with a dead­ly, can­cer-caus­ing mon­key virus (the SV40) has pre­cip­i­tat­ed a soft-tis­sue can­cer epi­dem­ic in those who were vac­ci­nat­ed, many years after they got the vac­cine.

Oth­er con­sid­er­a­tions to; be weighed include:

  • We have not­ed in the past that the mil­i­tary is fun­da­men­tal­ly involved with the U.S. vac­ci­na­tion pro­gram.
  • Mod­er­na’s his­to­ry is Inex­tri­ca­bly linked with DARPA.
  • Mod­er­na’s vac­cine devel­op­ment was super­vised by an unnamed Pen­ta­gon offi­cial known only as “the major.”
  • Mod­er­na as a com­pa­ny is to be viewed askance, as dis­cussed in FTR#1131.
  • The pub­licly tout­ed suc­cess of vac­cines is based on press releas­es, not peer-reviewed stud­ies.

In that con­text, it is impor­tant to stress that the FDA, in the clos­ing months of the Trump admin­is­tra­tion, elim­i­nat­ed the require­ment for long-term mon­i­tor­ing of vac­cine results for pos­si­ble neg­a­tive side effects.

We are not alone in our reser­va­tions.

” . . . . This deci­sion to cut the tri­als short could come back to haunt the FDA. For one thing, get­ting more data could have reas­sured mil­lions of Amer­i­cans who are cur­rent­ly ‘vac­cine hes­i­tant’ that the agency is look­ing out for them. These aren’t cranks. Some are health care work­ers, includ­ing doc­tors and nurs­es, peo­ple you would think would be the first in line to get their shots giv­en their expo­sure to the virus. We’ve talked to sev­er­al peo­ple in health­care who have eschewed the vac­cine. Many of them have been around long enough that they’ve come to dis­trust Big Phar­ma and/or the FDA. Stop­ping the tri­als ear­ly didn’t help. . . .”

“The FDA Cut Off Covid Vac­cine Test­ing. That Was a Real­ly Bad Idea.” by Shan­non Brown­lee and Jeanne Lenz­er; Wash­ing­ton Month­ly; 03/26/2021

The shots are sav­ing lives, but we don’t know their long-term effects thanks to an agency that often answers to indus­try instead of the pub­lic.

Not since the polio vac­cine became avail­able in April 1955 have Amer­i­cans been so excit­ed about get­ting a shot. After a year of iso­la­tion, fear, and death, most of us can hard­ly wait to get vac­ci­nat­ed against Covid-19. Grand­par­ents want to be able to hug their grand­chil­dren. Doc­tors and nurs­es want to care for their patients with­out hav­ing to wear the equiv­a­lent of a body con­dom, and many work­ers actu­al­ly want to go back to the office. The two of us are grate­ful to be among those who have already got­ten our shots.

From every­thing we know about the var­i­ous Covid-19 vac­cines, nor­mal life, or some sem­blance of it, could return as ear­ly as late sum­mer or fall in the Unit­ed States. The first two vac­cines, made by Pfiz­er and Mod­er­na, appear to be more than 90 per­cent effec­tive. The John­son & John­son vac­cine also looks to be quite effec­tive. Thus far, the side effects seem tol­er­a­ble. If there’s a prob­lem with the vac­cines, it’s that pro­duc­tion has not kept up with demand and rich coun­tries are scoop­ing up the major­i­ty of avail­able dos­es, leav­ing poor­er coun­tries to fend for them­selves.

But behind the scenes, there’s a lot we don’t know, espe­cial­ly about the vac­cines made by Pfiz­er and Mod­er­na, which employ a com­plete­ly nov­el tech­nol­o­gy involv­ing mRNA, a type of genet­ic mate­r­i­al. The rea­son we don’t know it is because of a deci­sion made back in Decem­ber by the U.S. Food and Drug Admin­is­tra­tion (FDA). The agency allowed man­u­fac­tur­ers to effec­tive­ly stop their clin­i­cal tri­als as soon as they were autho­rized to mar­ket their vac­cines. While the ear­ly results from the clin­i­cal tri­als look incred­i­bly promis­ing, we don’t actu­al­ly know with any pre­ci­sion just how effec­tive and safe they real­ly are – and we prob­a­bly nev­er will. That might sound like the kind of hair­split­ting that hard­ly mat­ters when a pan­dem­ic is rag­ing and people’s lives are at stake, but it does mat­ter for future vac­ci­na­tion cam­paigns. It’s worth con­sid­er­ing why the FDA did it and whether or not that’s how vac­cines and oth­er med­ical prod­ucts should be reg­u­lat­ed in the future.

First out of the gate was Pfizer’s vac­cine, which then-Pres­i­dent Don­ald Trump pro­nounced a “med­ical mir­a­cle” on Decem­ber 11 that would “save mil­lions of lives and end the pan­dem­ic once and for all.” The FDA grant­ed the vac­cine an emer­gency use autho­riza­tion (EUA) in record time. By Jan­u­ary, thou­sands of essen­tial work­ers in the Unit­ed States had already been vac­ci­nat­ed with either the Pfiz­er or Mod­er­na shot. The FDA grants an EUA based on pre­lim­i­nary data only in emer­gen­cies, and obvi­ous­ly the pan­dem­ic qual­i­fies. Full approval is with­held until clin­i­cal tri­als are com­plete. In the case of the Covid-19 vac­cine tri­als, a lot of experts were pray­ing the FDA would require the com­pa­nies to con­tin­ue the tri­als for a full two years as orig­i­nal­ly planned.

That’s because many vac­cines, along with drugs and med­ical devices, look “mirac­u­lous” at first – only to turn out to be less so as more data comes in. Most of these “med­ical rever­sals” occur because the prod­uct is less effec­tive than it first appeared. But some prod­ucts wind up being far more dan­ger­ous – like the pain med­i­cine Vioxx, which killed 55,000 Amer­i­cans before it was final­ly pulled from the mar­ket, and the Sprint Fidelis pace­mak­er, a device with faulty wires that caused hun­dreds of deaths and put anoth­er 150,000 peo­ple at risk of sud­den death.

Even before the first vac­cine came out, there were wor­ries the FDA would not hold the com­pa­nies’ feet to the fire and make them fin­ish the tri­als. In an edi­to­r­i­al pub­lished on Sep­tem­ber 10, Howard Bauch­n­er, the edi­tor in chief of the Jour­nal of the Amer­i­can Med­ical Asso­ci­a­tion and col­leagues wrote, “pre­ma­ture­ly approv­ing a vac­cine could under­mine Covid-19 vac­cine efforts and erode con­fi­dence in vac­cines more gen­er­al­ly.”

Bauch­n­er and oth­ers also pre­dict­ed that once the shots were avail­able to the pub­lic, study vol­un­teers would leave the vac­cine tri­als in droves in order to find out if they had got­ten the real vac­cine or a place­bo (dum­my shot) – so they could get the vac­cine as soon as pos­si­ble if they were on place­bo. That would under­mine the stud­ies, effec­tive­ly stop­ping them after just a medi­an of two months of data had been col­lect­ed. Once the stud­ies were stopped and the vac­cines were released to the gen­er­al pop­u­la­tion, it would be very hard to track side effects and effi­ca­cy.

It seemed like a dilem­ma with no solu­tion. The pan­dem­ic was rag­ing and ear­ly results from the tri­als looked high­ly promis­ing. The FDA could hard­ly with­hold autho­riza­tion of seem­ing­ly effec­tive vac­cines in the face of a rag­ing pan­dem­ic and a des­per­ate pub­lic. At the same time, the pos­i­tive ear­ly results from the tri­als, show­ing the vac­cines to be extreme­ly effec­tive with vir­tu­al­ly no side effects, might not stand the test of time.

Back in Sep­tem­ber, Antho­ny Fau­ci, who was then head of Pres­i­dent Trump’s Covid-19 task force and remains the chief of the Nation­al Insti­tute of Aller­gy and Infec­tious Dis­eases, had already pro­posed a clever plan. He rec­om­mend­ed a “blind­ed crossover design.” Vol­un­teers who had been in the place­bo group would be giv­en the real vac­cine, while vac­cine recip­i­ents would receive placebo—without any­body being told which they had got­ten first. In this way, all vol­un­teers would receive the vac­cine while allow­ing ongo­ing sur­veil­lance regard­ing long term safe­ty and effi­ca­cy. When the FDA called in Steven Good­man, an expert in clin­i­cal tri­al design from Stan­ford, he too endorsed the blind­ed crossover design, which is com­mon­ly used in med­ical research.

The man­u­fac­tur­ers were less than enthu­si­as­tic. They told the FDA that exe­cut­ing crossover stud­ies would be “oner­ous.” In this case, that word trans­lates to “expen­sive,” and there’s no doubt that con­tin­u­ing the tri­als would cost more mon­ey. Not to men­tion the fact that the longer the tri­als went, the more like­ly it would have been that the vac­cines would look a lit­tle worse than they did at first, at least in some pop­u­la­tions, like peo­ple with immune dis­or­ders. That’s pre­cise­ly the kind of data the FDA needs to pro­tect the pub­lic health. Nev­er­the­less, with a solu­tion offered by top experts on the one hand, and indus­try oppo­si­tion on the oth­er, FDA high­er ups made their deci­sion. Instead of insist­ing on the tri­als con­tin­u­ing, they asked the com­pa­nies to “inform the agency” of their plans. Was it pres­sure from the Trump White House, mem­bers of Con­gress, or some oth­er rea­son the FDA caved to indus­try, as often hap­pens? We can’t be sure, but the test­ing design Fau­ci and Good­man endorsed would have let the wider pub­lic get the vac­cine just as quick­ly.

This deci­sion to cut the tri­als short could come back to haunt the FDA. For one thing, get­ting more data could have reas­sured mil­lions of Amer­i­cans who are cur­rent­ly “vac­cine hes­i­tant” that the agency is look­ing out for them. These aren’t cranks. Some are health care work­ers, includ­ing doc­tors and nurs­es, peo­ple you would think would be the first in line to get their shots giv­en their expo­sure to the virus. We’ve talked to sev­er­al peo­ple in health­care who have eschewed the vac­cine. Many of them have been around long enough that they’ve come to dis­trust Big Phar­ma and/or the FDA. Stop­ping the tri­als ear­ly didn’t help.

Anoth­er rea­son longer tri­als would have been good pol­i­cy: Pub­lic health offi­cials and indi­vid­ual patients would prob­a­bly like to know who is least like­ly to be pro­tect­ed by the vac­cines and who is most vul­ner­a­ble to their side effects. Diana Zuck­er­man, pres­i­dent of the non-prof­it Nation­al Cen­ter for Health Research, says, “I’m espe­cial­ly con­cerned that Pfizer’s vac­cine tri­als includ­ed only five peo­ple aged 75 and old­er who were diag­nosed with­Covid-19.” She adds: “That makes it impos­si­ble to deter­mine how effec­tive the vac­cine is for frail elder­ly patients.”

There’s rea­son to wish we knew more about side effects for old­er patients. In a report from Fin­land, 23 frail, elder­ly peo­ple died short­ly after receiv­ing the vac­cine. Finnish researchers wrote that it was pos­si­ble that com­mon side effects of the vac­cine, such as vom­it­ing and diar­rhea, “that are not dan­ger­ous in fit­ter, younger patients … may aggra­vate under­ly­ing dis­ease in the elder­ly.” If the vac­cines turn out not to be ter­ri­bly effec­tive for old­er people—as is the case for the flu vaccine—and their side effects pose real dan­gers, nurs­ing homes and care facil­i­ties may need to use dif­fer­ent meth­ods to pro­tect elder­ly res­i­dents and patients. As things stand, it’s very hard to know because the tests were short-cir­cuit­ed.

This episode in the annals of poten­tial­ly wrong­head­ed FDA deci­sions bears direct­ly on the Biden administration’s deci­sion about who to nom­i­nate as FDA com­mis­sion­er. The two top picks are Janet Wood­cock, cur­rent act­ing com­mis­sion­er and 35-year vet­er­an at the agency ver­sus Joshua Sharf­stein, vice dean for pub­lic health prac­tice at Johns Hop­kins. Both are physi­cians and both have expe­ri­ence at the agency, and that’s pret­ty much where the sim­i­lar­i­ty between them ends. Wood­cock has presided over many of the most ques­tion­able drug approvals the FDA has made in recent mem­o­ry. She sees indus­try as a “part­ner,” and she’s the pre­ferred can­di­date of Phar­ma, device mak­ers, and sev­er­al patient groups, most of which receive indus­try fund­ing – pre­cise­ly because she has weak­ened the FDA’s over­sight.

Sharf­stein comes with a pub­lic health per­spec­tive and an acute aware­ness of the need to rebuild the agency’s rep­u­ta­tion as inde­pen­dent from both pol­i­tics and indus­try. As deputy com­mis­sion­er of the FDA dur­ing the Oba­ma pres­i­den­cy, he proved his met­tle when he head­ed an inter­nal inves­ti­ga­tion into the approval of an inef­fec­tive and harm­ful med­ical device. The inves­ti­ga­tion found that the FDA had caved to polit­i­cal and cor­po­rate inter­fer­ence by allow­ing the device, Menaflex, a knee implant made of cow car­ti­lage, on to the mar­ket over the objec­tions of agency sci­en­tists. . . . .

Discussion

One comment for “FDA’s Unfortunate Ruling about Vaccine Monitoring”

  1. Women report­ing swollen lymph nodes after COVID-19 vac­cine

    As more peo­ple are get­ting vac­ci­nat­ed doc­tors are see­ing an influx of women mak­ing mam­mo­gram appoint­ments after notic­ing swollen lymph nodes in the arm region where they got vac­ci­nat­ed.

    https://abc7news.com/health/women-reporting-swollen-lymph-nodes-after-covid-19-vaccine/10581619/

    Posted by Roberto Maldonado | May 5, 2021, 7:31 am

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