The mak­ing of an opi­oid epi­demic

When high doses of painkillers led to wide­spread ad­dic­tion, it was called one of the big­gest mis­takes in mod­ern medicine. But this was no ac­ci­dent.

The Guardian - Journal - - Front page - By Chris McGreal

Jane Bal­lan­tyne was, at one time, a true be­liever. The British-born doc­tor, who trained as an anaesthetist on the NHS be­fore her ap­point­ment to head the pain depart­ment at Har­vard and its as­so­ci­ated hos­pi­tal, drank up the prom­ise of opi­oid painkillers – drugs such as mor­phine and methadone – in the late 1990s. Bal­lan­tyne lis­tened to the evan­ge­lists among her col­leagues who painted the drugs as magic bul­lets against the scourge of chronic pain blight­ing mil­lions of Amer­i­can lives. Doc­tors such as Rus­sell Portenoy at the Me­mo­rial Sloan Ket­ter­ing Can­cer Cen­ter in New York saw how ef­fec­tive mor­phine was in eas­ing the pain of dy­ing can­cer pa­tients thanks to the hospice move­ment that came out of the UK in the 1970s.

Why, the new think­ing went, could the same opi­oids not be made to work for peo­ple grap­pling with the phys­i­cal and men­tal toll of de­bil­i­tat­ing pain from arthri­tis, wrecked knees and bod­ies worn out by phys­i­cally de­mand­ing jobs? As Portenoy saw it, opi­ates were ef­fec­tive painkillers through most of recorded his­tory and it was only out­dated fears about ad­dic­tion that pre­vented the drugs still play­ing that role.

Opi­oids were lan­guish­ing from the legacy of an ear­lier epi­demic that prompted Pres­i­dent Theodore Roo­sevelt to ap­point the US’s first opium com­mis­sioner, Dr Hamil­ton Wright, in 1908. Portenoy wanted to lib­er­ate them from this taint. Wright de­scribed Amer­i­cans as “the great­est drug fiends in the world”, and opium and mor­phine as a “na­tional curse”. Af­ter that the med­i­cal pro­fes­sion treated opi­oid pain re­lief with what Portenoy and his col­leagues re­garded as un­war­ranted fear, stig­ma­tis­ing a valu­able medicine.

These new evan­ge­lists painted a pic­ture of a na­tion awash in chronic pain that could be re­lieved if only the med­i­cal pro­fes­sion would over­come its prej­u­dices.

They con­structed a web of claims they said were rooted in sci­ence to back their case, in­clud­ing an as­ser­tion that the risk of ad­dic­tion from nar­cotic painkillers was “less than 1%” and that dosages could be in­creased with­out limit un­til the pain was over­come. But the ev­i­dence was, at best, thin and in time would not stand up to de­tailed scru­tiny. One the­ory, pro­moted by Dr David Had­dox, was that pa­tients gen­uinely ex­pe­ri­enc­ing pain could not be­come ad­dicted to opi­oids be­cause the pain neu­tralised the eu­pho­ria caused by the nar­cotic. He said that what looked to pre­scrib­ing doc­tors like a pa­tient hooked on the drug was “pseudo-ad­dic­tion”.

Portenoy toured the coun­try, de­scrib­ing opi­oids as a gift from na­ture and pro­mot­ing ac­cess to nar­cotics as a moral ar­gu­ment. Be­ing pain-free was a hu­man right, he said. In 1993, he told the New York Times of a “grow­ing lit­er­a­ture show­ing that these drugs can be used for a long time, with few side-ef­fects, and that ad­dic­tion and abuse are not a prob­lem”.

Long af­ter the epi­demic took hold, and the death toll rose into the hun­dreds of thou­sands in the US, Portenoy ad­mit­ted that there was lit­tle ba­sis for this claim and that he had been more in­ter­ested in chang­ing at­ti­tudes to opi­oids among doc­tors than in sci­en­tific rigour.

“In essence, this was ed­u­ca­tion to des­tig­ma­tise and be­cause the pri­mary goal was to des­tig­ma­tise, we of­ten left ev­i­dence be­hind,” he ad­mit­ted years later as the scale of the epi­demic un­folded.

Like­wise, Had­dox’s the­ory of pseudo-ad­dic­tion was based on the study of a sin­gle can­cer pa­tient. At the time, though, the new think­ing was a lib­er­a­tion for pri­mary care doc­tors frus­trated at the limited help they could of­fer pa­tients beg­ging to get a few hours’ sleep. Bal­lan­tyne was as en­thu­si­as­tic as any­one and be­gan teach­ing the gospel of pain re­lief at Har­vard, and em­brac­ing opi­oids to treat her pa­tients.

“Our mes­sage was a mes­sage of hope,” she said. “We were teach­ing that we shouldn’t with­hold opi­ates from peo­ple suf­fer­ing from chronic pain and that the risks of ad­dic­tion were pretty low be­cause that was the teach­ing we’d re­ceived.”

But then Bal­lan­tyne be­gan to see signs in her pa­tients that ex­pe­ri­ence wasn’t match­ing the­ory. Doc­tors were told they could re­peat­edly ratchet up the dosage of nar­cotics and switch to a new and pow­er­ful drug, OxyCon­tin, with­out en­dan­ger­ing the pa­tient, be­cause the pain, in ef­fect, can­celled out the risk of ad­dic­tion. To her dis­may, Bal­lan­tyne saw that many of her pa­tients were not bet­ter off when tak­ing the drugs and were show­ing signs of de­pen­dence.

Among those pa­tients on high doses over months and years, Bal­lan­tyne heard from one af­ter an­other that the more drugs they took, the worse their pain be­came. But if they tried to stop or cut back on the pills, their pain also wors­ened. They were trapped.

“You had never seen peo­ple in such agony as these peo­ple on high doses of opi­ates,” she told me. “And we thought it’s not just be­cause of the un­der­ly­ing pain; it’s to do with the med­i­ca­tion.”

As Bal­lan­tyne lis­tened to rel­a­tives of her pa­tients talk about how much the drugs had changed their loved ones, her mis­giv­ings grew. Hus­bands spoke of wives as if a part of them were lost. Moth­ers com­plained that chil­dren had be­come sullen and dis­tant, their judg­ment gone, their per­son­al­ity warped, their char­ac­ter al­tered. None of this should have been hap­pen­ing. Pain re­lief was sup­posed to free the pa­tients, not im­prison them. It was all very far from the prom­ise of a magic bul­let.

As the ev­i­dence that opi­oids were not de­liv­er­ing as promised piled up, the Har­vard spe­cial­ist be­gan to record her find­ings. By then, though, there were other pow­er­ful forces with a big fi­nan­cial stake in the wider pre­scrib­ing of painkilling drugs. Phar­ma­ceu­ti­cal com­pa­nies are not slow to spot an op­por­tu­nity and the push for wider pre­scrib­ing of opi­oids had not gone un­no­ticed by the drug-mak­ers, in­clud­ing the man­u­fac­turer of OxyCon­tin, Pur­due Pharma, which rapidly came to play a cen­tral role in the epi­demic.

As the in­flu­ence of the opi­oid evan­ge­lists grew, and re­straints on pre­scrib­ing loos­ened, the phar­ma­ceu­ti­cal in­dus­try moved to the fore with a push to make opi­oids the de­fault treat­ment for pain, and to take ad­van­tage of the huge prof­its to be made from mass pre­scrib­ing of a drug that was cheap to pro­duce.

The Amer­i­can Pain So­ci­ety, a body par­tially funded by phar­ma­ceu­ti­cal com­pa­nies, was push­ing the con­cept of pain as the “fifth vi­tal sign”, along­side other mea­sures of health such as heart rate and blood pres­sure. “Vi­tal signs are taken se­ri­ously,” said its pres­i­dent, James Camp­bell, in a 1996 speech to the so­ci­ety. “If pain were as­sessed with the same zeal as other vi­tal signs are, it would have a much bet­ter chance of be­ing treated prop­erly. We need to train doc­tors and nurses to treat pain as a vi­tal sign.”

The APS wanted the prac­tice of check­ing pain as a vi­tal sign as a mat­ter of rou­tine adopted in Amer­i­can hospi­tals. The key was to win over the Joint Com­mis­sion for Ac­cred­i­ta­tion of Health­care Or­ga­ni­za­tions, which cer­ti­fies about 20,000 hospi­tals and clin­ics in the US. Its stamp of ap­proval is the gate­way for med­i­cal fa­cil­i­ties to tap into the huge pot of fed­eral money pay­ing for health­care for older, dis­abled and poor peo­ple. Hospi­tals are care­ful not to get on the wrong side of the joint com­mis­sion’s “best prac­tices” or to fail its reg­u­lar per­for­mance re­views.

In re­sponse to what it called “the na­tional out­cry about the wide­spread prob­lem of un­der-treat­ment” – an out­cry in good part gen­er­ated by drug man­u­fac­tur­ers – the com­mis­sion is­sued new stan­dards for pain care in 2001. Hos­pi­tal ad­min­is­tra­tors picked over the doc­u­ment to en­sure they un­der­stood ex­actly what was re­quired.

Ev­ery pa­tient was to be asked about their pain lev­els, no mat­ter what the rea­son they were see­ing a doc­tor. Hospi­tals adopted a sys­tem of colour-coded smiley faces, to rep­re­sent a ris­ing scale of pain from 0-10. The com­mis­sion ruled that any­body iden­ti­fy­ing as a five – a yel­low neu­tral face de­scribed as “very dis­tress­ing”

– or above was to be was to be re­ferred for a pain con­sul­ta­tion.

The com­mis­sion told hospi­tals they would be ex­pected to meet the new stan­dards for pain man­age­ment at their next ac­cred­i­ta­tion sur­vey. Pur­due Pharma was ready. The com­pany of­fered to dis­trib­ute ma­te­ri­als to ed­u­cate doc­tors in pain man­age­ment for free. This amounted to ex­clu­sive rights to in­doc­tri­nate med­i­cal staff. A train­ing video as­serted that there is

“no ev­i­dence that ad­dic­tion is a sig­nif­i­cant is­sue when per­sons are given opi­oids for pain con­trol”, and claimed that some clin­i­cians had “in­ac­cu­rate and ex­ag­ger­ated con­cerns about ad­dic­tion, tol­er­ance and risk of death”. Nei­ther claim was true.

Some doc­tors ques­tioned the value of pa­tient self­assess­ment, but the com­mis­sion’s reg­u­la­tions soon came to be viewed as a rigid stan­dard. In time, pain as the fifth vi­tal sign worked its way into hos­pi­tal cul­ture. New gen­er­a­tions of nurses, steeped in the opi­oid or­tho­doxy, some­times came to see pain as more im­por­tant than other health in­di­ca­tors.

Dr Roger Chou, a pain spe­cial­ist at Ore­gon Health and Sci­ence Univer­sity who has made long-term stud­ies of the ef­fec­tive­ness of opi­oid painkillers and helped shape the Cen­ters for Dis­ease Con­trol and Preven­tion’s pol­icy on the epi­demic, said the fo­cus on pain caused pa­tients to give it greater weight than made sense.

“When you start ask­ing peo­ple: ‘How much pain are you hav­ing?’ ev­ery time they come into the hos­pi­tal, then peo­ple start think­ing: ‘Well, maybe I shouldn’t be hav­ing this lit­tle ache I’ve been hav­ing. Maybe there’s some­thing wrong.’ You’re med­i­cal­is­ing what’s a nor­mal part of life,” he said.

One con­se­quence was that peo­ple with rel­a­tively mi­nor pain were in­creas­ingly di­rected to­ward medic­i­nal treat­ment while con­sid­er­a­tion of safer or more ef­fec­tive al­ter­na­tives, such as phys­io­ther­apy, were marginalised. An­other, said Chou, was the in­creased ex­pec­ta­tion that pain can be elim­i­nated. Chas­ing the low­est score on the pain chart of­ten came at the ex­pense of qual­ity of life as opi­oid doses in­creased. “It’s bet­ter to have a lit­tle bit of pain and be func­tional than to have no pain and be com­pletely un­func­tional,” said Chou.

Health in­sur­ance com­pa­nies piled yet more pres­sure on doc­tors to fol­low the path of least re­sis­tance. This meant cut­ting con­sul­ta­tion times and pay­ments for more costly forms of pain treat­ment in favour of the di­rect ap­proach: drugs.

The joint com­mis­sion needed a way to judge whether its 2001 edict on pain was be­ing ad­hered to and latched on to pa­tient sat­is­fac­tion sur­veys. It took a de­ter­mined doc­tor to re­sist the pres­sure to pre­scribe. Physi­cians could spend half an hour press­ing a per­son to take more re­spon­si­bil­ity for their own health – eat bet­ter, ex­er­cise more, drink less, find ways to deal with stress – only to watch an un­happy pa­tient make their views known on the sat­is­fac­tion sur­vey and face a dress­ing down from hos­pi­tal man­age­ment. Or they could quickly do what the pa­tient came in for: give them a pill and get full marks.

In Detroit, Dr Charles Lucas’s three decades of ex­pe­ri­ence as a sur­geon told him it was pos­si­ble to what was easy and sign the pre­scrip­tion, or to do what was hard. Lucas grew up in the city and had been in­stru­men­tal in es­tab­lish­ing Detroit’s pub­licly owned hos­pi­tal as the high­est-level trauma cen­tre in Michi­gan and one of the first top-tier cen­tres in the coun­try.

Emer­gency de­part­ments be­came bea­cons for the opi­oid de­pen­dent, who quickly learned to game the sys­tem to get drugs on top of their pre­scrip­tions. They turned up feign­ing pain, know­ing ha­rassed med­i­cal staff un­der pres­sure of time and the com­mis­sion’s stan­dards were likely to pre­scribe nar­cotics and move on with­out too many ques­tions.

“Some of the old-time nurses, they have that jaun­diced look in their eye and say ‘So-and-so’s com­plain­ing of pain’. You can tell by the look in their eye that they don’t think it’s jus­ti­fied that they get any more medicine,” said Lucas. “The younger nurses, they say we have to treat this pain – be­cause they’ve been in­doc­tri­nated – they’ve got to get rid of the pain. God for­bid you don’t get rid of the pain. That would be like a mor­tal sin.”

But there was a price for re­sist­ing the pres­sure to pre­scribe ever higher doses of pain re­lief.

Lucas was knocked back in sur­prise, and then in­fu­ri­ated, to be sum­moned to ap­pear be­fore his hos­pi­tal’s ethics com­mit­tee af­ter a nurse re­ported him for fail­ing to pro­vide ad­e­quate pain treat­ment.

The sur­geon’s long­stand­ing pa­tients in­cluded Gail Pur­ton, the wife of a well-known Michi­gan ra­dio per­son­al­ity. Lucas op­er­ated on Pur­ton a few times, and she was back for surgery af­ter her ovar­ian can­cer spread. “It was a big op­er­a­tion. Cut off all sorts of can­cer.” The next day, a nurse asked Pur­ton if she was in pain. Pur­ton said she was. The nurse re­ported Lucas for fail­ing to prop­erly ad­dress a pa­tient’s pain. “I got re­ported be­cause I wasn’t giv­ing her enough pain medicine. She had a big cut from here to here,” Lucas said, run­ning his fin­ger across the front of his shirt and scoff­ing at the idea that she could be pain-free af­ter an op­er­a­tion like that.

The sur­geon re­sponded with a five-page let­ter to the ethics com­mit­tee chair­man, whom he hap­pened to have trained, chal­leng­ing the ques­tion­ing of his pro­fes­sional judg­ment. Pur­ton wrote her own let­ter, prais­ing Lucas’s care and say­ing that she never ex­pected not to have pain af­ter a ma­jor op­er­a­tion.

The case was dropped, but it was not an iso­lated in­ci­dent. Lucas has worked closely with an­other sur­geon, Anna Ledger­wood, since 1972. She too was hauled be­fore the ethics com­mit­tee on more than one oc­ca­sion, on the same charge. It cleared Ledger­wood, but Lucas said more ju­nior sur­geons buck­led to the pres­sure to ad­min­is­ter opi­oids just to stay out of trou­ble.

Lucas re­garded the new pain or­tho­doxy as a grow­ing tyranny. He also thought it was killing pa­tients. He be­gan to col­lect his own data.

As the joint com­mis­sion was push­ing out its new stan­dards for pain treat­ment in the early 2000s, the in­dus­try was driv­ing a par­al­lel ef­fort to in­flu­ence the pre­scrib­ing habits of doc­tors in small clin­ics and pri­vate prac­tices across the coun­try. Many were still hes­i­tant to pre­scribe nar­cotics, in part be­cause of fear of le­gal li­a­bil­ity for over­dose or ad­dic­tion.

The Amer­i­can Pain So­ci­ety and Had­dox, who was by then work­ing for Pur­due Pharma, were in­stru­men­tal in writ­ing a pol­icy doc­u­ment re­as­sur­ing doc­tors they would not face dis­ci­plinary ac­tion for pre­scrib­ing nar­cotics, even in large quan­ti­ties. The in­dus­try latched on to the Fed­er­a­tion of State Med­i­cal Boards be­cause of its in­flu­ence over health pol­icy in­di­vid­ual US states which reg­u­late how doc­tors prac­tise medicine.

In 2001, Pur­due Pharma funded the dis­tri­bu­tion of new pain treat­ment guide­lines drawn up by the FSMB that sounded many of the same themes as the stan­dards writ­ten by the joint com­mis­sion.

The doc­u­ment picked up on Had­dox’s pseu­doad­dic­tion the­ory. “Physi­cians should recog­nise that tol­er­ance and phys­i­cal de­pen­dence are nor­mal con­se­quences of sus­tained use of opi­oid anal­gesics and are not syn­ony­mous with ad­dic­tion,” it said.

The pa­tients more took, drugs the worse their pain be­came. But cut­ting back did not p

Big pharma poured money into keep­ing the drugs flow­ing, claim­ing there was an epi­demic of un­treated pain

The FSMB pressed state med­i­cal boards to adopt the guide­lines and to re­as­sure doc­tors that ad­her­ing to them would di­min­ish the like­li­hood of dis­ci­plinary ac­tion.

Over the fol­low­ing decade, the FSMB took close to

$2m (£1.52m) from the drug in­dus­try, which mostly went to pro­mote the guide­lines and to fi­nance a book, Re­spon­si­ble Opi­oid Pre­scrib­ing, writ­ten with the over­sight and ad­vice of a clutch of doc­tors who were strong ad­vo­cates of wider use of pre­scrip­tion nar­cotics. The book was sold to state med­i­cal boards and health de­part­ments for dis­tri­bu­tion to physi­cians, clin­ics and hospi­tals. The drug in­dus­try paid for the pub­li­ca­tion but the FSMB kept the $270,000 prof­its from sales.

Within a few years, the model guide­lines were adopted in full or in part by 35 states, and the flood­gates were open to mass pre­scrib­ing of what Drug En­force­ment Ad­min­is­tra­tion agents came to call “heroin in a pill”. Opi­oids were soon the de­fault treat­ment even for rel­a­tively mi­nor pain. Den­tists gave them to teenagers af­ter pulling their wis­dom teeth. Not just one or two days’ worth of pills, but a fort­night or a month’s worth, which, if they did not draw the in­tended re­cip­i­ent in, fre­quently sat in the medicine cabi­net wait­ing to be dis­cov­ered by some­one else in the fam­ily. The lack of cau­tion in pre­scrib­ing left an im­pres­sion among the users that the drugs were harm­less, and some peo­ple shared them with oth­ers as eas­ily as they might an as­pirin. Pre­scrib­ing es­ca­lated year on year. So did prof­its. OxyCon­tin sales passed $1bn a year in 2000. Three years later they were twice that. Other opi­oid mak­ers were pulling in huge prof­its too.

By the time the FSMB guide­lines were land­ing in doc­tors’ in­boxes in the early 2000s, Bal­lan­tyne had reached her own con­clu­sions about the im­pact of es­ca­lat­ing opi­oid pre­scrib­ing. In 2003, she co-au­thored an ar­ti­cle in the New Eng­land Jour­nal of Medicine high­light­ing the dearth of com­pre­hen­sive tri­als and say­ing that two im­por­tant ques­tions re­mained unan­swered even as mass pre­scrib­ing of opi­oids took off. Do they work long term? Are higher doses safe to take year af­ter year? The drug in­dus­try and opi­oid evan­ge­lists said yes, but where was the ev­i­dence for it?

Bal­lan­tyne wrote that there was ev­i­dence that putting some pa­tients on se­rial pre­scrip­tions of strong opi­oids has the op­po­site of the in­tended ef­fect. High doses not only build up a tol­er­ance to the drug, but cause in­creased sen­si­tiv­ity to pain. The drugs were de­feat­ing them­selves.

Her as­sess­ment seemed to warn that if there was an epi­demic of pain, it was partly driven by the cure. On top of that, there was ev­i­dence that the drugs were toxic. Then came the con­clu­sion that stuck a dag­ger into the heart of the cam­paign for wider opi­oid pre­scrib­ing. “Whereas it was pre­vi­ously thought that un­lim­ited dose es­ca­la­tion was at least safe, ev­i­dence now sug­gests that pro­longed, high-dose opi­oid ther­apy may be nei­ther safe nor ef­fec­tive,” she wrote.

Bal­lan­tyne was also in­creas­ingly aware that the claim that pain neu­tralised the risk of ad­dic­tion was false. Quan­ti­fy­ing ad­dic­tion, and who may be vul­ner­a­ble, is no­to­ri­ously dif­fi­cult. Bal­lan­tyne, like a lot of doc­tors, es­ti­mated that be­tween 10 and 15% of the pop­u­la­tion is vul­ner­a­ble, but that it de­pends on the sub­stance and cir­cum­stances. What she was cer­tain of was that Pur­due’s high-strength pill, OxyCon­tin, had been a game changer. “The long-act­ing opi­ates sud­denly put much higher doses into peo­ple’s hands and much more of it, and tak­ing it around the clock made them de­pen­dent on it.”

From her re­search, Bal­lan­tyne con­cluded that OxyCon­tin su­per­charged what was al­ready wide­spread de­pen­dence on weaker opi­oid pills by draw­ing a new group of peo­ple into the cat­e­gory at risk of ad­dic­tion and death. The dan­ger was com­pounded by OxyCon­tin’s fail­ure to live up to its prom­ise of hold­ing pain at bay for 12 hours. For some pa­tients, it wore off af­ter eight, caus­ing them to take three pills a day in­stead of two, greatly in­creas­ing their over­all dose of nar­cotic and with it the risk of ad­dic­tion.

Bal­lan­tyne thought the ar­ti­cle would at least cause her pro­fes­sion and the drug in­dus­try to take stock of the im­pact of mass pre­scrib­ing. By the time the ar­ti­cle ap­peared, the doc­u­mented death toll from pre­scrip­tion opi­oids was run­ning at around 8,000 a year.

“When the 2003 New Eng­land jour­nal ar­ti­cle came out, I thought it was go­ing to make the med­i­cal com­mu­nity sit up and say: ‘Wow. These drugs that we’ve been think­ing are help­ing peo­ple are not. We have a real prob­lem.’ But the med­i­cal com­mu­nity didn’t at all say: ‘Wow,’” Bal­lan­tyne said with half a laugh, 15 years later.

“Peo­ple in my field who had been, like me, taught we have to do this – peo­ple who’d been lob­by­ing to try and in­crease opi­ate use, like the pal­lia­tive care physi­cians – said: ‘What are you do­ing? We worked so hard to get to this point, and now you’re go­ing to turn it all around. They be­come so rat­tled when you sug­gest you shouldn’t give the opi­ates – it’s partly peo­ple in the pain field and es­pe­cially peo­ple in pharma – be­cause it’s big busi­ness.”

Lucas and Ledger­wood had their own study on the im­pact of opi­oids in the works. They came to be­lieve the tyranny of the colour-coded smiley faces was cost­ing lives. Years of surgery have given Lucas a healthy re­spect for pain as a tool for re­cov­ery. To sup­press it was dan­ger­ous. But as large doses of opi­oids be­came the norm, the sur­geon noted an in­creas­ing num­ber of in­ci­dents of pa­tients strug­gling to breathe af­ter rou­tine oper­a­tions and be­ing moved to in­ten­sive care.

Lucas and Ledger­wood vis­ited trauma cen­tres to col­lect data on deaths be­fore and af­ter the joint com­mis­sion stan­dards on pain treat­ment. In 2007, the two doc­tors pub­lished their find­ings. Be­fore the com­mis­sion’s dic­tum, 0.7% of trauma cen­tre pa­tients died from “ex­cess ad­min­is­tra­tion of pain medicines”. The death toll rose to 3.6% af­ter the com­mis­sion’s poli­cies kicked in.

“In each case, ad­min­is­tra­tion of se­da­tion led to a change in vi­tal signs or a de­te­ri­o­ra­tion in the res­pi­ra­tory sta­tus re­quir­ing some type of in­ter­ven­tion which, in turn, led to a cas­cade of events re­sult­ing in death,” the pa­per said. Those were only the deaths in which there was lit­tle doubt opi­oids were re­spon­si­ble, and the real toll was al­most cer­tainly higher. “Over­med­i­ca­tion with seda­tives/nar­cotics … clearly con­trib­uted to deaths,” the study con­cluded.

“I’m con­vinced that be­cause of the pres­sures brought to bear by the joint com­mis­sion, we are killing peo­ple,” Lucas told me. The study said the med­i­cal staff lived in fear of the joint com­mis­sion stan­dards which cre­ated “great psy­cho­log­i­cal pres­sure on care­givers” to use nar­cotics.

In a damn­ing cri­tique, the pa­per said that the com­mis­sion’s re­liance on pain scales to guide treat­ment had cre­ated an “ex­ces­sive em­pha­sis on un­der­med­i­ca­tion at the same time ig­nor­ing over­med­i­ca­tion”. The ob­ses­sion with en­sur­ing peo­ple were not in pain came at the ex­pense of ig­nor­ing the dan­gers of giv­ing large amounts of opi­oids to peo­ple re­cov­er­ing from surgery or se­ri­ous in­jury. The drugs may kill the pain but they also risked killing the pa­tient.

The two doc­tors made no se­cret of who they blamed for “this pre­ventable cause of death and dis­abil­ity”. “It’s about money. Money has in­flu­ence, and it in­flu­enced the joint com­mis­sion,” said Lucas.

The sur­geon pre­sented the pa­per to a meet­ing of the Cen­tral Sur­gi­cal As­so­ci­a­tion and saw it pub­lished by the Jour­nal of the Amer­i­can Col­lege of Sur­geons un­der the head­line “Kind­ness Kills: The Neg­a­tive Im­pact of Pain as the Fifth Vi­tal Sign.”

Af­ter­wards, Lucas got a stream of let­ters and emails from doc­tors who recog­nised the prob­lem. But, un­like Bal­lan­tyne, he wasn’t sur­prised when the pol­icy re­mained the same. “Did I ex­pect a change? No. It is too in­grained into the med­i­cal pro­fes­sion. It’s be­come fi­nan­cial just like the drug in­dus­try is fi­nan­cial. It’s noth­ing to do with right or wrong. It’s about how the money flows,” he said. “When you write a pa­per you want there to be un­emo­tional data out there. You want that un­emo­tional data to be an­a­lysed and in­ter­preted in one way or the other, but you don’t ex­pect the Re­nais­sance.”

In 2012, nine years af­ter Bal­lan­tyne’s cau­tion­ing against the mass pre­scrib­ing of opi­oids as a quick fix for pain was pub­lished in the New Eng­land Jour­nal of Medicine, a renowned British pain spe­cial­ist, Cathy Stan­nard, called the doc­tor’s pa­per “a dis­tant warn­ing bell”, chal­leng­ing the open­ing of the flood­gates to strong opi­oids.

Bal­lan­tyne con­tin­ued to col­lect data and pub­lish ever more de­tailed in­sights into the im­pact of painkillers. A less ra­pa­cious drug in­dus­try might have paused in its head­long charge to sell opi­oids, and less blink­ered and com­pli­ant reg­u­la­tors might have de­ter­mined that this was the mo­ment to weigh the claims made in favour of per­mit­ting such wide­spread pre­scrib­ing.

In­stead the phar­ma­ceu­ti­cal com­pa­nies took the warn­ings as a chal­lenge to their busi­ness in­ter­ests. Through the 2000s, in­dus­try poured money into a po­lit­i­cal strat­egy to keep the drugs flow­ing. It funded front groups and stud­ies to claim that there was in­deed an epi­demic – but it was of un­treated pain. The mil­lions cop­ing with chronic pain were the real vic­tims, the in­dus­try said, not the “abusers” hooked on opi­oids they of­ten bought on the black mar­ket or ob­tained from crooked doc­tors. That one fre­quently be­came the other was con­ve­niently over­looked.

Pharma’s lob­by­ists worked to per­suade Congress and the reg­u­la­tors that to curb opi­oid pre­scrib­ing would be to pun­ish the real vic­tims be­cause of the sins of the “abusers”, and it worked. As a re­sult, the dev­as­ta­tion ran unchecked for an­other decade and more. By 2010, doc­tors in the US were writ­ing more than 200m opi­oid pre­scrip­tions a year. As the pre­scrib­ing rose, so did the death toll. Last year, more than 72,000 Amer­i­cans died of drug over­doses, the vast ma­jor­ity from opi­oids, nearly 10 times the num­ber at the time Bal­lan­tyne pub­lished her warn­ing.

The head of the FDA at the time OxyCon­tin was ap­proved for dis­tri­bu­tion two decades ago, Dr David Kessler, later de­scribed the opi­oid cri­sis as an “epi­demic we failed to fore­see”. “It has proved to be one of the big­gest mis­takes in mod­ern medicine,” he said.

Kessler was wrong. It wasn’t a mis­take. It was a be­trayal. •


Pur­due Pharma’s pre­scrip­tion painkiller OxyCon­tin


A me­mo­rial to peo­ple killed by pre­scrip­tion opi­oid over­dose, Wash­ing­ton DC

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