ARE DRUG STUD­IES MA­NIP­U­LATED?

likely to be pub­lished than neg­a­tive ones. And even seem­ingly small dif­fer­ences can “rep­re­sent bil­lions of dol­lars on the world mar­ket,” says Gøtzsche. The prin­ci­ple, nonethe­less,

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“The ma­nip­u­la­tion of clin­i­cal stud­ies is so wide­spread and so se­ri­ous that you should only con­sider the re­ports on these stud­ies as ad­ver­tise­ments for med­i­cal drugs,” says Pro­fes­sor Peter Gøtzsche, direc­tor of the Nordic Cochrane Cen­ter in Copen­hagen – a state­ment that is sure to make him some en­e­mies. These are ex­tremely harsh words, di­rected not only against the phar­ma­ceu­ti­cal industry but also against those doc­tors and re­searchers who re­main silent on the mat­ter. The truth is, that’s what most doc­tors do. But what does that mean for pa­tients?

New re­search has found that clin­i­cal tri­als and re­search funded by phar­ma­ceu­ti­cal com­pa­nies is more likely to pro­duce re­sults that are bi­ased in favour of the spon­sor’s medicine.

Joel Lexchin, a Toronto doc­tor, an­a­lysed 30 re­ports ex­am­in­ing phar­ma­ceu­ti­cal industry-funded re­search and found that the stud­ies were four times more likely to be pos­i­tive than re­search funded by in­de­pen­dent spon­sors. “What we found was that in al­most all cases there was a bias – a rather heavy bias – in favour [of a drug] when the study was industry funded,” said Lexchin. In ac­tual fact, phar­ma­ceu­ti­cal com­pa­nies don’t need to in­vent or make up re­sults – it’s enough to weigh facts dif­fer­ently or leave them out en­tirely. Pos­i­tive stud­ies are far more

“The phar­ma­ceu­ti­cal industry spends twice as much on ad­ver­tis­ing as it does on re­search and de­vel­op­ment.” DR JOEL LEXCHIN, YORK UNI­VER­SITY OF TORONTO

seems sim­ple: those who have the fi­nan­cial clout de­cide the re­sults, some­thing con­firmed by ran­dom spot checks car­ried out by the Cochrane Cen­ter. These showed that at least 50% of funded drug stud­ies fi­nanced by phar­ma­ceu­ti­cal com­pa­nies are in­flu­enced in their favour. How­ever, such ma­nip­u­lated stud­ies do not stand in the way of drugs be­ing ap­proved – be­cause to date there are “nei­ther cross-dis­ci­plinary stan­dards for the peer review process, nor mea­sur­able qual­ity cri­te­ria” ac­cord­ing to Pro­fes­sor Flaminio Squaz­zoni from the Uni­ver­sity of Bres­cia in Italy.

The real scan­dal, how­ever, is that it is no se­cret.

Ac­cord­ing to re­search car­ried out by the Cochrane Col­lab­o­ra­tion, tens of thou­sands of ma­nip­u­lated stud­ies have been pub­lished. Doc­tors should know about this. They have a huge re­spon­si­bil­ity to their pa­tients, who ex­pect them to be in­formed about sig­nif­i­cant med­i­cal de­vel­op­ments, par­tic­u­larly when these per­tain to a drug that they pre­scribe. But his­tory shows that many drugs or treat­ments con­tinue to be pre­scribed even though stud­ies no longer sup­port their use. Con­sider PSA tests for the early di­ag­no­sis of prostate can­cer. Even the man who de­vel­oped them, Dr Richard Ablin, now ad­vises against their use be­cause most of these can­cers are slow-grow­ing and do not re­quire treat­ment. But doc­tors con­tinue to use them. The same is true of the seda­tive di­azepam (Val­ium). Al­though it’s been known for 30 years that the drug is as ad­dic­tive as heroin, it is still pre­scribed.

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