An­tipsy­chotic Re­ac­tion

THE RECK­LESS OVER­PRE­SCRIB­ING OF AN­TIPSY­CHOTICS IS CRE­AT­ING A DEADLY COCK­TAIL FOR TOO MANY VETS

Newsweek International - - OPIOIDS - —ART LEVINE

THE LAST TIME JANETTE LAYNE saw her hus­band alive, Sergeant Eric Layne was doz­ing on their couch with the TV on. That was in Jan­uary 2008. Be­cause of his mount­ing out­bursts of rage and para­noia since re­turn­ing from Iraq, psy­chi­a­trists at two Veter­ans Af­fairs hos­pi­tals had been pre­scrib­ing him in­creas­ing doses of a drug cock­tail for post-trau­matic stress dis­or­der that in­cluded the pow­er­ful an­tipsy­chotic Sero­quel. Al­though not ap­proved by the FDA for such “off-la­bel” uses, Sero­quel is among the most pre­scribed drugs in its class and at its peak brought in more than $5 bil­lion a year for its man­u­fac­turer, As­trazeneca, de­spite side ef­fects rang­ing from di­a­betes to sud­den car­diac ar­rest.

Eric kept com­plain­ing of headaches and tremors—con­cerns that were dis­counted by the VA med­i­cal staff— while he gained weight, had trou­ble breath­ing and was so overse­dated that, Janette says, he had be­come a “zom­bie.” Two weeks after he re­turned from a spe­cial­ized in­pa­tient PTSD pro­gram that in­creased his med­i­ca­tion, he was dead. “All these doc­tors and medics and Ph.d.s kept telling us that he was fine,” Janette says. “We trusted the doc­tors.”

Crit­ics of the VA es­ti­mate that more than 400 com­bat veter­ans and other mil­i­tary per­son­nel have died sud­denly after be­ing over­med­i­cated with PTSD “cock­tails.” These fa­tal­i­ties aren’t sys­tem­at­i­cally mon­i­tored or stud­ied. The few mil­i­tary and VA in­quiries into this is­sue have largely blamed these mys­te­ri­ous deaths on sui­cides and nat­u­ral causes—or, in a few cases, on some in­ex­pli­ca­ble “drug tox­i­c­ity.”

Dur­ing the same post-9/11 years that an­tipsy­chotic pre­scrib­ing in­creased at the VA, it was in the early stages of an ini­tia­tive to cut down on pre­scrib­ing for PTSD pa­tients re­ceiv­ing po­ten­tially ad­dic­tive ben­zo­di­azepines such as Klonopin, Xanax and Resto­ril. Mean­while, the depart­ment al­lowed the use of Sero­quel to jump more than 770 per­cent be­tween 2001 and 2010, al­though, ac­cord­ing to the As­so­ci­ated Press, the num­ber of pa­tients in­creased only 34 per­cent.

Over $1.8 bil­lion was spent by the VA from 2001 through the first half of 2015 on the two most pre­scribed an­tipsy­chotics for PTSD, Ris­perdal and Sero­quel, al­though they were never proved ef­fec­tive or even ap­proved by the FDA for use with the dis­or­der. Sero­quel re­mains the most heav­ily pre­scribed an­tipsy­chotic in the VA sys­tem, with nearly 800,000 pre­scrip­tions an­nu­ally.

All of As­trazeneca’s mar­ket­ing of Sero­quel for off-la­bel uses, as the Jus­tice Depart­ment found when it reached a $520 mil­lion set­tle­ment with the com­pany in 2010, has con­tin­ued to pay off. The drug re­mains off-la­bel for PTSD, anx­i­ety, in­som­nia and de­pres­sion in youth, but vir­tu­ally no one in the VA ap­pears to be pay­ing at­ten­tion. As a psy­chi­a­trist at the Hunt­ing­ton VA hos­pi­tal tells this

re­porter, “The drug companies pushed these new drugs for ev­ery­thing from alope­cia to hem­or­rhoids to lum­bago.”

That push ig­nored the data. “The ev­i­dence for us­ing an­tipsy­chotics with PTSD pa­tients isn’t very good, and the po­ten­tial side ef­fects can be deadly,” says Dr. J. Dou­glas Brem­ner, the chief of Emory Univer­sity Med­i­cal School’s Clin­i­cal Neu­ro­science Re­search Unit.

Part of the VA’S re­luc­tance to rein in the high-risk, off-la­bel pre­scrib­ing of an­tipsy­chotics traces back to “the code,” but also to the un­due in­flu­ence of the drug in­dus­try. Some of the ear­li­est work that pushed Sero­quel on veter­ans came from Dr. Mark Ham­ner, the direc­tor of psy­chophar­ma­col­ogy re­search and PTSD clin­i­cal care at the Ralph H. John­son VA Med­i­cal Cen­ter in Charleston, South Carolina. With sup­port from As­trazeneca, he re­searched a se­ries of longun­pub­lished stud­ies boost­ing Sero­quel.

As­trazeneca was ap­par­ently so pleased with Ham­ner’s work that it funded di­rectly or served as a “col­lab­o­ra­tor” with the VA on two ad­di­tional 12-week stud­ies on Sero­quel for PTSD symp­toms. For nearly a decade or more, the stud­ies’ out­comes were known only to Ham­ner and, pre­sum­ably, As­trazeneca. Re­tired Bri­gadier Gen­eral Dr. Stephen Xe­nakis, a pi­o­neer­ing PTSD re­searcher who re­viewed Ham­ner’s stud­ies for Newsweek, thinks he knows why the re­sults weren’t made pub­lic for years: “As­trazeneca clearly de­layed pub­lish­ing be­cause the data in gen­eral is weak.” Ham­ner de­nied that his ties to the com­pany played any role in his pub­lish­ing de­lays.

The drug in­dus­try and VA of­fi­cials have kept veter­ans and their fam­i­lies ig­no­rant about many of the dan­gers posed by these psy­chi­atric med­i­ca­tions. Sero­quel and other an­tipsy­chotics can in­duce sud­den car­diac ar­rest that, al­though a rare side ef­fect, of­ten causes brain death in un­der five min­utes. Atyp­i­cal an­tipsy­chotics have been iden­ti­fied in over 100 stud­ies since the 1990s as per­haps the sin­gle riski­est class of drugs for in­duc­ing a par­tic­u­larly dan­ger­ous form of ar­rhyth­mia. Dr. Fred Baugh­man, a re­tired Cal­i­for­nia-based neu­rol­o­gist who launched a cam­paign rais­ing alarms about Sero­quel-re­lated deaths in West Vir­ginia, was blunt in his many press re­leases and let­ters to med­i­cal jour­nals, start­ing in 2008: “There is an epi­demic of sud­den deaths oc­cur­ring through­out the U.S. mil­i­tary.”

His de­ter­mi­na­tion to discover what led to the med­i­ca­tion-linked deaths didn’t seem to be matched by the VA’S Of­fice of the In­spec­tor Gen­eral, which con­cluded there was no link be­tween Sero­quel and other lead­ing an­tipsy­chotics with sud­den car­diac death in its re­port on the death of Eric. All of the in­spec­tor gen­eral’s work ig­nored the most salient med­i­cal re­search and the VA’S pre­scrib­ing guide­lines in place since 2004. “They turned a blind eye to the med­i­cal con­sen­sus,” says Baugh­man of the in­spec­tor gen­eral’s re­port.

The most telling sign of a cover-up, he con­tends, is the fail­ure to men­tion the most thor­ough re­view then avail­able: an Ex­pert Opin­ion on Drug Safety journal re­view, pub­lished sev­eral months be­fore the in­spec­tor gen­eral’s re­port. “It took an overt act of omis­sion to miss this article,” he says, not­ing how widely it was cited in the med­i­cal lit­er­a­ture. Xe­nakis, the for­mer Army psy­chi­a­trist, is just as blunt: “They cherry-picked the stud­ies.” The VA’S Of­fice of the In­spec­tor Gen­eral de­clined to re­veal what med­i­cal guide­lines or sci­en­tific re­search was re­viewed be­fore re­leas­ing its re­port.

Dr. Grace Jackson, a for­mer Navy psy­chi­a­trist and au­thor of Re­think­ing

Psy­chi­atric Drugs, says after re­view­ing the in­spec­tor gen­eral’s re­port and White’s pre­scrip­tion his­tory, “This is a white­wash that san­i­tizes [White’s] med­i­cal records. It’s a com­plete em­bar­rass­ment. The way these drugs were used was overkill.”

Nearly a decade after the in­spec­tor gen­eral ig­nored the drugs’ car­diac dan­gers, the VA’S new Psy­chotropic Drug Safety Ini­tia­tive, mod­eled in part on its opi­ate cam­paign, still hasn’t flagged the car­diac risk of Sero­quel, the agency’s most pre­scribed an­tipsy­chotic. “It’s out­ra­geous,” Xe­nakis says of this omis­sion. “Peo­ple are talk­ing about re­form in the VA, but with these kinds of things, it re­ally ex­poses how far we have to go to change ba­sic prac­tices, cul­ture and at­ti­tudes.”

There is an epi­demic of SUD­DEN DEATHS oc­cur­ring through­out the U.S. mil­i­tary.”

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