The wait is over: Even with­out social­ist health­care you can enjoy drug rationing. More than 200 drugs – from chemother­a­py sta­ples to antibi­otics, from anes­the­sia to mor­phine – are now being denied to crit­i­cal­ly ill peo­ple, rationed or scalped at stratos­pher­ic prices. Qual­i­ty prob­lems, includ­ing poten­tial­ly dead­ly micro­bial con­t­a­m­i­na­tion, caused more than half the recent short­ages in injectable drugs, accord­ing to the Food and Drug Administration.

‘A lot of companies are making money hand-over-fist and not caring, not putting resources into old drugs with proven track records, and instead into ones that might be more profitable.’

​”Phar­ma­cists are scram­bling and des­per­ate,” says Aman­da Forster of Pre­mier Inc., a major hos­pi­tal drug-pur­chas­ing coop­er­a­tive. Five years ago the FDA report­ed only 55 drugs in short sup­ply; by 2010, there were 178; and this year, Pre­mier pre­dicts, 350. The major­i­ty are low-prof­it gener­ics, but big-name drugs are also affect­ed. Hard-to-make ster­ile injecta­bles such as anes­the­sias and chemother­a­pies are par­tic­u­lar­ly hard hit.

Ondis Ear­den­sohn dis­cov­ered the prob­lem first­hand on August 8, when the for­mer rur­al Ver­mont post­mas­ter and part­ner of the state archivist drove two hours to New Hampshire’s Dart­mouth Hitch­cock Hos­pi­tal for an infu­sion of Dox­il. The John­son & John­son (J&J) chemother­a­py drug is one of the only remain­ing treat­ments for her stage‑4 can­cer. She went through the usu­al tests and was wait­ing for the infu­sion when her doc­tor walked in. “‘I’m sor­ry,’ he told me, ​‘but we don’t have enough Dox­il to treat you.’ “

“I drove home with no treat­ment. I was in shock,” said Ear­den­sohn, 58, a warm and usu­al­ly opti­mistic moth­er of two. ​“When you are at stage‑4, your options get more and more lim­it­ed. If you have one option tak­en away, it may have been your last.” A week lat­er, the region’s major teach­ing hos­pi­tal called her at home the night before her appoint­ment to can­cel anoth­er Dox­il treatment.

Short­age fatalities

Dart­mouth Hitch­cock is not alone in being unable to sup­ply some life-sav­ing drugs, and in shop­ping for oth­ers on the gray mar­ket, where unof­fi­cial, unau­tho­rized mid­dle­man-com­pa­nies shill vital drugs like Times Square scalpers. In the first six months of 2011, some 99.5 per­cent of hos­pi­tals report­ed at least one drug short­age, accord­ing to a June Amer­i­can Hos­pi­tal Asso­ci­a­tion sur­vey; 44 per­cent fell short on more than 20 drugs, and 78 per­cent rationed supply.

Short­ages cost hos­pi­tals about $200 mil­lion a year. But there is a deep­er price. The AHA sur­vey revealed that short­ages have caused ​“adverse patient out­comes” at 35 per­cent of facil­i­ties. The non­prof­it Insti­tute for Safe Med­ica­tion Prac­tices linked short­age-relat­ed drug sub­sti­tu­tions to patient deaths.

In June, J&J had warned that no new patients could be start­ed on Dox­il, but that old patients like Ear­den­sohn would be giv­en pri­or­i­ty for the life-extend­ing drug through its warm­ly acronym-ized pro­gram: C.A.R.E.S. But on August 26, the hos­pi­tal decid­ed to switch her to a dif­fer­ent drug. Eardensohn’s doc­tors had appar­ent­ly lost faith in J&J’s abil­i­ty to sup­ply Dox­il – even for the con­tin­u­ing patients for whom they C.A.R.E.[D].

“There are some [old users] that are qual­i­fied, but haven’t got­ten Dox­il,” admits J&J spokesper­son Mon­i­ca Neu­fang. How many? The length of the ​“wait­ing list” is ​“pro­pri­etary,” she says, and J&J ​“wouldn’t give that infor­ma­tion to the FDA.”

The caus­es for the short­ages are almost as var­ied as the drugs affect­ed, but prof­it con­sid­er­a­tions are almost always a fac­tor. In addi­tion to con­t­a­m­i­na­tion, cost-cut­ting man­u­fac­ture, lack of raw ingre­di­ents, just-in-time pro­duc­tion, Medicare price con­trols, pay-to-delay gener­ic sweet­heart deals, dis­con­tin­u­a­tion of less lucra­tive prod­ucts, out­sourc­ing and sub­stan­dard ingre­di­ents can impact sup­ply and quality.

J&J insists that the Dox­il short­age is ​“not due to con­cerns about prod­uct qual­i­ty or safe­ty.” The prob­lem, says Neu­fang, is ​“pro­duc­tion delays.”

In fact, it is not J&J that is doing the pro­duc­ing. Although Dox­il bears the J&J brand, it is out­sourced and pro­duced by Ben Venue Lab­o­ra­to­ries, an Ohio-based third-par­ty con­tract man­u­fac­tur­er. BVL press mate­ri­als also vague­ly blame ​“man­u­fac­tur­ing capac­i­ty constraints.”

But Health Cana­da sug­gests an alter­na­tive. On August 17, Canada’s FDA coun­ter­part banned impor­ta­tion of some BVL drugs for ​“qual­i­ty defi­cien­cies” and what Health Cana­da spokesper­son Olivia Caron calls ​“short­com­ings in the Good Man­u­fac­tur­ing Prac­tices … includ­ing prod­uct ster­il­iza­tion and qual­i­ty oversight.”

Rec­og­niz­ing that des­per­ate patients have nowhere to turn, Cana­da is allow­ing impor­ta­tion of Dox­il and a few oth­er ​“med­ical­ly nec­es­sary drugs from BVL as the health ben­e­fits of these drugs out­weigh the risk asso­ci­at­ed with the qual­i­ty concerns.”

BVL spokesper­son Jason Kutz said that con­clud­ing there was a link between the Cana­di­an ban and qual­i­ty issues was ​“inac­cu­rate and misleading.”

With­in days of the Cana­di­an actions, and also fac­ing restric­tions on its prod­ucts in Europe, BVL announced it was quit­ting con­tract-man­u­fac­tur­ing. A divi­sion of Boehringer Ingel­heim, based in Ger­many with affil­i­ates in more than 100 coun­tries, BVL also pro­duces for Pfiz­er, Take­da and Bris­tol-Myers Squibb. BVL is part of a vast $46 bil­lion glob­al con­tract-man­u­fac­tur­ing indus­try that plays a major role in the increas­ing glob­al­iza­tion of the drug industry.

The glob­al drug sup­ply chain

Dox­il is just one break in a world-wide sup­ply chain cor­rod­ed by Washington’s lax reg­u­la­tion and industry’s need to turn a profit.

Some indus­tries more than oth­ers: In a move that makes Big Phar­ma look like Doc­tors With­out Bor­ders, gray-mar­ket price gougers are spec­u­lat­ing, prof­i­teer­ing and cash­ing in, big time. Con­cen­trat­ing on the scarce, essen­tial drugs that treat patients extreme­ly ill with can­cer and infec­tions, or need­ing surgery, the gray mar­keters are extort­ing price hikes aver­ag­ing 650 percent.

Which sounds almost human­i­tar­i­an com­pared to the ​“aston­ish­ing markup of 6,213 per­cent” report­ed by the San Anto­nio Express-News. The faxed gray-mar­ket price for the life­sav­ing leukemia drug Cytara­bine was among many offers del­ug­ing pharmacists.

“It’s shock­ing behav­ior,” says Premier’s Forster. ​“Peo­ple are hoard­ing and prof­i­teer­ing on essen­tial drugs to squeeze mon­ey out of hos­pi­tals.” Gray-mar­ket drugs raise safe­ty con­cerns, she says, since before reach­ing a hos­pi­tal phar­ma­cy, they can pass through five or six bro­kers, get­ting repack­aged, rela­beled and pos­si­bly stored under poor conditions.

But qual­i­ty and safe­ty prob­lems also affect drugs obtained through nor­mal chan­nels. ​“The largest per­cent­age of cur­rent short­ages is caused by domes­tic qual­i­ty prob­lems,” Mike Levy, act­ing direc­tor of Drug Secu­ri­ty, Integri­ty and Recalls at FDA, told In These Times.

“[D]rugmakers in the U.S. are increas­ing­ly imple­ment­ing cost-cut­ting mea­sures that may direct­ly or indi­rect­ly con­tribute to an increas­ing num­ber of man­u­fac­tur­ing qual­i­ty issues,” Busi­ness Mon­i­tor Inter­na­tion­al wrote. Last year Teva and Hos­pi­ra – two of the Unit­ed States’ largest mak­ers of gener­ics, includ­ing key chemother­a­pies – closed fac­to­ries because of ​“man­u­fac­tur­ing prob­lems.” J&J units had to issue mas­sive recalls, and the FDA placed three of its plants under con­sent decrees for per­sis­tent fail­ures to meet qual­i­ty standards.

Big Pharma’s ris­ing reliance on cheap­er import­ed ingre­di­ents and fin­ished drugs is com­pound­ing the prob­lem. ​“The race to the bot­tom has led to an increase of prod­ucts com­ing from plants in Chi­na and India that may have uncer­tain sup­ply and may have nev­er been inspect­ed,” Heather Bresch, pres­i­dent of the gener­ic drug giant Mylan told The New York Times. A 2007 GAO report found that 586 U.S. drugs were made in Chi­na and 299 in India.

The avail­abil­i­ty and puri­ty of for­eign ingre­di­ents is a fac­tor in the U.S. drug sup­ply chain since – accord­ing to Huas­car Batista, act­ing chief of the Import Oper­a­tions Branch, Office of Com­pli­ance at FDA – ​“80 per­cent of all active phar­ma­ceu­ti­cal ingre­di­ents con­sumed in the U.S. are imported.”

While J&J and BVL deny qual­i­ty prob­lems with Dox­il, both stonewall ques­tions on for­eign sourc­ing. ​“It’s pro­pri­etary,” Ney­fang said. ​“Ask Ben Venue.” BLV’s Kurtz sug­gests ask­ing J&J.

Mean­while, the FDA, which is charged with ensur­ing safe­ty, is hob­bled by bud­get con­straints, indus­try ties and the irre­press­ible demands of BigPharma’s deep-pock­et­ed con­gres­sion­al lob­by­ists. ​“The grow­ing chal­lenges of glob­al­iza­tion have far out­stripped the nation’s prod­uct safe­ty inspec­tion and qual­i­ty mon­i­tor­ing resources,” FDA Senior Reg­u­la­to­ry Coun­sel Car­olyn Beck­er told a $1,995-per-person phar­ma­ceu­ti­cal indus­try con­fer­ence in ear­ly August.

It’s bad enough that the FDA inspects domes­tic facil­i­ties about once every 2.5 years, but it would take 9 years to inspect the pri­or­i­tized list of com­pa­nies in the 150 or so coun­tries that export drugs or ingre­di­ents into Amer­i­ca, the GAO reports. It cer­tain­ly doesn’t help that the FDA lacks author­i­ty to man­date recalls, require pri­or noti­fi­ca­tion of impend­ing short­ages and force com­pa­nies to con­tin­ue man­u­fac­tur­ing essen­tial drugs.

And even when prob­lems are found with imports, the FDA can’t destroy poor qual­i­ty or dan­ger­ous drugs. It can only refuse them entry, after which importers can ​“port shop” the reject­ed prod­ucts: ​“They try at sev­er­al dif­fer­ent ports, and some­times they are suc­cess­ful [in get­ting them into the U.S.],” says the FDA’s Batista.

That there is plen­ty of blame to go around is no help to Ear­den­sohn. She won­ders why gray mar­keters were able to hoard essen­tial drugs when hos­pi­tals and gov­ern­ment agen­cies did not ade­quate­ly antic­i­pate or pre­pare for short­ages: ​“A lot of com­pa­nies are mak­ing mon­ey hand over fist and not car­ing, not putting resources into old drugs with proven track records, and instead into ones that might be more prof­itable.” Indeed, while Dox­il is a main­stay chemother­a­py agent, it earns J&J less than 1 per­cent of its revenue.

“This thing hor­ri­fies me, and not just for me,” says Ear­den­sohn, who has devel­oped a cough dur­ing the extra month she waits with­out treat­ment. ​“This is a kind of health­care rationing. Why hasn’t some­thing been done?”