Fear of Reprisals Keeps Hon­est FDA Re­searchers Gagged

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How the FDA keeps its re­searchers from say­ing what the agency wants kept quiet.

Many have lev­eled charges against the Food and Drug Ad­min­is­tra­tion (FDA) for cor­rup­tion in the ranks. Re­cently, those con­cerns reached a new level of anger as sci­en­tists from the FDA sent new let­ters to Congress doc­u­ment­ing se­ri­ous cases of FDA re­tal­i­a­tion for those who chal­lenged or­ders by its se­nior man­age­ment.

Among the many claims in­cluded in the let­ters is a fed­eral dis­trict court case go­ing back to 2009 that was sum­ma­rized by FDA sci­en­tists in a 2009 let­ter to Pres­i­dent Obama: “The lat­est ex­am­ple of wrong­do­ing was re­ported on March 23, 2009, from a Fed­eral Dis­trict Court Judge who ruled that [the] FDA’S de­ci­sion on the Plan B drug [in a par­tic­u­lar case] was ‘ar­bi­trary and capri­cious be­cause [it was] not the re­sult of rea­soned and good faith agency de­ci­sion-mak­ing.’ [The] FDA’S top lead­ers at the Cen­ter for Drug Eval­u­a­tion and Re­search (CDER) tes­ti­fied that they ‘didn’t have a choice and ... [weren’t] sure that [they] would be al­lowed to re­main [in their po­si­tions if they] didn’t agree’ to ig­nore the sci­ence and the law. To the con­trary, they should be re­moved from their po­si­tions of au­thor­ity pre­cisely be­cause they didn’t fol­low the sci­ence and the law. The judge fur­ther ruled that there was ‘un­re­but­ted ev­i­dence that the FDA’S [de­ci­sion] stemmed from po­lit­i­cal pres­sure rather than per­mis­si­ble health and safety con­cerns.’ The im­proper po­lit­i­cal in­flu­ence and the many de­par­tures from its own poli­cies re­veal that such FDA of­fi­cials are in­ca­pable of en­sur­ing in­tegrity and sci­ence at [the] FDA.”

1

The same doc­u­ment cites an­other ex­am­ple: “On Oc­to­ber 14, 2008, FDA physi­cians and sci­en­tists wrote to mem­bers of the House En­ergy and Com­merce Com­mit­tee re­port­ing that top FDA of­fi­cials at the Cen­ter for De­vices and Ra­di­o­log­i­cal Health (CDRH) had dis­torted the sci­en­tific re­view of med­i­cal de­vices and then re­tal­i­ated against those who brought this to light. Con­gress­man John Din­gell (then Chair­man) and Con­gress­man Bart Stu­pak (Chair­man, Sub­com­mit­tee on Over­sight and In­ves­ti­ga­tions) wrote to then FDA Com­mis­sioner Dr. An­drew C. von Eschen­bach (since re­signed), stat­ing that there were ‘well-doc­u­mented al­le­ga­tions that se­nior man­agers within CDRH’ had ‘acted in vi­o­la­tion of the law ... [and that] sweep­ing mea­sures may be nec­es­sary to ad­dress the dis­tor­tion of sci­ence al­leged by so many CDRH sci­en­tists.’”

1

“… vi­o­la­tions of the fed­eral Rack­e­teer In­flu­enced Cor­rupt Or­ga­ni­za­tions Act (RICO) on be­half of Plain­tiffs Terry As­ton, John Fratti, Linda Martin, David Melvin, Es­ter Schulkin, and Jen­nifer Wil­cox, who were di­rectly and prox­i­mately in­jured by the in­ten­tional, will­ful, and neg­li­gent ac­tions and in­ac­tions of each and ev­ery De­fen­dant, in­clud­ing John­son & John­son, John­son & John­son Phar­ma­ceu­ti­cal Re­search & De­vel­op­ment, L.L.C., Or­tho-mcneil-janssen Phar­ma­ceu­ti­cals, Inc., Re­nais­sance Tech­nolo­gies, L.L.C., Peter F. Brown, Dr. Mar­garet A. Ham­burg, Robert L. Mercer, and James H. Si­mons. De­fen­dants, each and ev­ery one of them, act­ing in con­cert jointly and sev­er­ally, through the use of the in­ter­state mail and wires, en­tered into and fur­thered a con­spir­acy to il­le­gally and crim­i­nally in­flu­ence the Com­mis­sioner of the Food & Drug Ad­min­is­tra­tion and the Food & Drug Ad­min­is­tra­tion to mis­la­bel and mis­brand a drug in or­der to make and sell an in­her­ently dan­ger­ous drug by de­fraud­ing con­sumers such as Plain­tiffs in or­der to ac­quire and reap fi­nan­cial gain, in­clud­ing but not lim­ited to:

“1) driv­ing up or main­tain­ing the price of shares of De­fen­dant John­son & John­son stock

“2) in­creas­ing the fi­nan­cial hold­ings and value of De­fen­dant John­son & John­son stock held by De­fen­dant Re­nais­sance Tech­nolo­gies, L.L.C.

“3) in­creas­ing De­fen­dant Re­nais­sance Tech­nolo­gies, LLC’S cor­po­rate in­come thereby in­creas­ing fi­nan­cial re­mu­ner­a­tion and gain to De­fen­dants Peter F. Brown, Robert L. Mercer, and James H. Si­mons by virtue of Dr. Mar­garet A. Ham­burg’s mar­riage to Peter F. Brown

“4) in­creas­ing cor­po­rate in­come of the of­fi­cers of De­fen­dant John­son & John­son, De­fen­dant John­son & John­son Phar­ma­ceu­ti­cal Re­search & De­vel­op­ment, LLC, and Or­tho-mcneil-janssen Phar­ma­ceu­ti­cals, Inc.

“5) avoid­ing po­ten­tial law­suits against De­fen­dant John­son & John­son, De­fen­dant John­son & John­son Phar­ma­ceu­ti­cal Re­search & De­vel­op­ment, LLC, and Or­tho-mcneil-janssen Phar­ma­ceu­ti­cals, Inc.

“6) in­creas­ing the com­bined wealth of De­fen­dants Dr. Mar­garet A. Ham­burg and her hus­band, De­fen­dant Peter F. Brown, by virtue of the above.” 2

For those won­der­ing what the quote about the “com­bined wealth” is all about in the com­plaint, it has come to light that Dr. Ham­burg’s hus­band’s hedge fund held over a half a bil­lion dol­lars of stock from Le­vaquin’s man­u­fac­turer, John­son & John­son.

With the pres­sure of the grow­ing pub­lic out­rage over the FDA’S be­hav­ior in ma­nip­u­lat­ing its staff, as well as word of the rack­e­teer­ing charges against Dr. Ham­burg and the drug’s man­u­fac­turer hit­ting the press, the FDA fi­nally or­dered that Le­vaquin be re­moved from the mar­ket on May 12, 2016. It did so with the state­ment, long over­due, that the use of Le­vaquin can pro­duce “dis­abling and po­ten­tially per­ma­nent se­ri­ous side ef­fects.”

With the ma­nip­u­la­tion process so em­bed­ded in the FDA, the gov­ern­ment that sup­pos­edly pro­vides over­sight over it, and the drug com­pa­nies whose ex­ec­u­tives’ bil­lions of dol­lars in bonuses de­pend on it, this is far from the end of this story.

As just one more ex­am­ple, an­other let­ter by FDA sci­en­tists plead­ing for help had its own sep­a­rate list of ad­di­tional ev­i­dence of cor­rup­tion, in­clud­ing the or­der­ing of physi­cians and sci­en­tists to ig­nore guid­ance doc­u­ments pre­pared by the FDA it­self, re­mov­ing black box warn­ings sup­plied by FDA ex­perts and even al­low­ing FDA sub­or­di­nates to pro­vide writ­ten threats of dis­ci­plinary ac­tion if physi­cians and sci­en­tists did not change their of­fi­cial sci­en­tific opin­ions and rec­om­men­da­tions to prop­erly align them with man­age­ment.

The let­ter con­cluded that the “cul­ture of wrong­do­ing and cover-up is noth­ing new but is part of a long­stand­ing pat­tern of be­hav­ior.”

No one in any se­nior po­si­tion se­ri­ously be­lieves that even these let­ters, law­suits and pub­lic al­le­ga­tions will change things quickly. But with strong pub­lic sup­port for change, more law­suits and per­haps one or two brave souls at the top, maybe that change will hap­pen soon enough to pre­vent any­one else from be­ing phys­i­cally hurt be­cause the wrong prod­uct was ap­proved by a cor­rupt FDA.

Ref­er­ences:

1) Let­ter from FDA rep­re­sen­ta­tives to Pres­i­dent Barack Obama on April 2, 2009.

http://a.abcnews.go.com/im­ages/pol­i­tics/grass­ley-let­ter-fda.pdf

2) Case Com­plaint 1:16-cv-00086, Doc­u­ment 1, Filed 01/18/16 by Terry As­ton, John Fratti, Linda Martin, David Melvin, Es­ter Schulkin, and Jen­nifer Wil­cox, Plain­tiffs, vs. John­son & John­son, John­son & John­son Phar­ma­ceu­ti­cal Re­search & De­vel­op­ment, L.L.C., Or­tho-mcneil-janssen Phar­ma­ceu­ti­cals, Inc., Re­nais­sance Tech­nolo­gies, L.L.C., Peter F. Brown, Robert L. Mercer, James H. Si­mons, and Dr. Mar­garet A. Ham­burg.

http://www.lar­ryk­lay­man.com/pdf/160119-fi­nal%20 Filed%20lev­aquin%20com­plaint%20.pdf

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