TEDMED 2012
Ben Goldacre: What doctors don't know about the drugs they prescribe
Ben Goldejker (Ben Goldacre): Šta lekari ne znaju o lekovima koje prepisuju
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Kada se testira novi lek, rezultate ispitivanja bi trebalo učiniti dostupnim čitavom medicinskom svetu - ali negativni ili dvosmisleni rezultati gotovo nikada ne budu objavljeni, što ostavlja doktore i istraživače u mraku. U ovom vatrenom govoru, Ben Goldejker objašnjava zašto je neobjavljivanje negativnih podataka posebno varljivo i opasno.
Ben Goldacre - Debunker
Ben Goldacre unpicks dodgy scientific claims made by scaremongering journalists, dubious government reports, pharmaceutical corporations, PR companies and quacks. Full bio
Ben Goldacre unpicks dodgy scientific claims made by scaremongering journalists, dubious government reports, pharmaceutical corporations, PR companies and quacks. Full bio
Double-click the English transcript below to play the video.
00:16
Hi. So, this chap here,
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Zdravo. Dakle, ovaj momak
00:19
he thinks he can tell you the future.
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misli da može predvideti vašu budućnost.
00:21
His name is Nostradamus, although here the Sun have
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Zove se Nostradamus,
a časopis "Sunce" ga je
a časopis "Sunce" ga je
00:23
made him look a little bit like Sean Connery. (Laughter)
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prikazao tako da podseća na Šona Konerija.
(Smeh)
(Smeh)
00:27
And like most of you, I suspect, I don't really believe
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Pretpostavljam da većina vas, kao i ja
00:30
that people can see into the future.
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ne veruje da ljudi mogu videti budućnost.
00:31
I don't believe in precognition, and every now and then,
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Ne verujem u vidovitost, ali povremeno
00:33
you hear that somebody has been able to predict something that happened in the future,
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čujete da neko može
da predvidi događaje u budućnosti,
da predvidi događaje u budućnosti,
00:37
and that's probably because it was a fluke, and we only
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to je verovatno samo slučajnost, a mi samo
00:40
hear about the flukes and about the freaks.
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čujemo o slučajnostima i odstupanjima.
00:42
We don't hear about all the times that people got stuff wrong.
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Ne čujemo o svim onim situacijama
kada su oni pogrešili.
kada su oni pogrešili.
00:46
Now we expect that to happen with silly stories
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Mi očekujemo da se to dogodi u smešnim
00:49
about precognition, but the problem is,
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slučajevima vidovitosti, ali problem je
00:52
we have exactly the same problem in academia
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što se sa time nosimo i u nauci
00:55
and in medicine, and in this environment, it costs lives.
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i u medicini, a u tim okolnostima, plaća se životima.
01:00
So firstly, thinking just about precognition, as it turns out,
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Prvo, razmišljajući samo o vidovitosti,
01:03
just last year a researcher called Daryl Bem conducted
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prošle godine je istraživač Deril Bem sproveo
01:05
a piece of research where he found evidence
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istraživanje u kom je došao do dokaza
01:07
of precognitive powers in undergraduate students,
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o postojanju vidovitosti kod studenata.
01:11
and this was published in a peer-reviewed academic journal
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To je objavljeno u naučnom časopisu,
01:14
and most of the people who read this just said, "Okay, well,
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a većina ljudi koja je to pročitala
jednostavno je rekla:
jednostavno je rekla:
01:16
fair enough, but I think that's a fluke, that's a freak, because I know
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“OK, ali mislim da je to slučajnost,
to je odstupanje jer znam
to je odstupanje jer znam
01:18
that if I did a study where I found no evidence
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da ako bih ja uradio studiju koja ne dokazuje
01:21
that undergraduate students had precognitive powers,
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postojanje vidovitosti studenata,
01:23
it probably wouldn't get published in a journal.
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ona verovatno ne bi bila objavljena.”
01:27
And in fact, we know that that's true, because
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U stvari, znamo da je to tačno
01:30
several different groups of research scientists tried
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jer je nekoliko različitih grupa istraživača pokušalo
01:32
to replicate the findings of this precognition study,
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da ponovi nalaze ove studije o vidovitosti,
01:36
and when they submitted it to the exact same journal,
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a kada su ih predali istom tom časopisu,
01:38
the journal said, "No, we're not interested in publishing
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dobili su odgovor:
“Ne, nismo zainteresovani za ponovljenu
“Ne, nismo zainteresovani za ponovljenu
01:42
replication. We're not interested in your negative data."
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studiju. Nismo zainteresovani
za vaš negativan rezultat.”
za vaš negativan rezultat.”
01:46
So this is already evidence of how, in the academic
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Već ovo je dokaz kako u naučnoj
01:49
literature, we will see a biased sample of the true picture
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literaturi možemo videti
pogrešan uzorak stvarne slike
pogrešan uzorak stvarne slike
01:54
of all of the scientific studies that have been conducted.
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svih naučnih studija koje su sprovedene.
01:57
But it doesn't just happen in the dry academic field of psychology.
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Ovo se ne dešava samo u
akademskom izučavanju psihologije.
akademskom izučavanju psihologije.
02:02
It also happens in, for example, cancer research.
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Na primer, ovo se takođe dešava
u istraživanju karcinoma.
u istraživanju karcinoma.
02:06
So in March, 2012, just one month ago, some researchers
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Tako su pre samo mesec dana,
u martu 2012. neki istraživači
u martu 2012. neki istraživači
02:10
reported in the journal Nature how they had tried
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objavili u časopisu "Nature"
kako su pokušali
kako su pokušali
02:13
to replicate 53 different basic science studies looking at
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da ponove 53 različite studije
bazičnih nauka koje su
bazičnih nauka koje su
02:17
potential treatment targets in cancer,
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proučavale moguće ciljeve terapije karcinoma
02:20
and out of those 53 studies, they were only able
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i od te 53 studije, mogli su uspešno
02:23
to successfully replicate six.
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da ponove šest.
02:26
Forty-seven out of those 53 were unreplicable.
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Četrdeset i sedam od ovih 53 nisu mogli da ponove.
02:30
And they say in their discussion that this is very likely
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U diskusiji su tvrdili da je to verovatno
02:34
because freaks get published.
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jer se odstupanja objavljuju.
02:37
People will do lots and lots and lots of different studies,
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Ljudi će uraditi mnogo i mnogo različitih studija,
02:39
and the occasions when it works they will publish,
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uspešni slučajevi će biti objavljeni,
02:41
and the ones where it doesn't work they won't.
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a neuspešni neće.
02:43
And their first recommendation of how to fix this problem,
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Njihova prva preporuka
kako da rešimo ovaj problem,
kako da rešimo ovaj problem,
02:47
because it is a problem, because it sends us all down blind alleys,
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a to jeste problem,
jer nas sve šalje niz slepe ulice,
jer nas sve šalje niz slepe ulice,
02:50
their first recommendation of how to fix this problem
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njihova prva preporuka
kako rešiti ovaj problem je
kako rešiti ovaj problem je
02:52
is to make it easier to publish negative results in science,
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da se olakša objavljivanje
negativnih naučnih rezultata
negativnih naučnih rezultata
02:55
and to change the incentives so that scientists are
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i da se promene motivi tako da ohrabe
02:58
encouraged to post more of their negative results in public.
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naučnike da objave
veći broj negativnih rezultata.
veći broj negativnih rezultata.
03:02
But it doesn't just happen in the very dry world
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Ovo se ne događa samo
u veoma izolovanoj oblasti
u veoma izolovanoj oblasti
03:06
of preclinical basic science cancer research.
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prekliničkih bazičnih istraživanja karcinoma.
03:10
It also happens in the very real, flesh and blood
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Takođe se događa u veoma stvarnoj, od krvi i mesa
03:14
of academic medicine. So in 1980,
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oblasti naučne medicine.
Tako su 1980.
Tako su 1980.
03:17
some researchers did a study on a drug called lorcainide,
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neki istraživači proučavali lek lorkainid,
03:20
and this was an anti-arrhythmic drug,
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koji je antiaritmik
03:23
a drug that suppresses abnormal heart rhythms,
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i suzbija nepravilan srčani ritam,
03:25
and the idea was, after people have had a heart attack,
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a ideja je bila da će ljudi,
nakon doživljenog srčanog udara,
nakon doživljenog srčanog udara,
03:27
they're quite likely to have abnormal heart rhythms,
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vrlo verovatno patiti od nepravilnog srčanog ritma,
03:29
so if we give them a drug that suppresses abnormal heart
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pa ako im se da lek
koji sprečava poremećaj srčane
koji sprečava poremećaj srčane
03:31
rhythms, this will increase the chances of them surviving.
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ritmike, povećaće se verovatnoća
njihovog preživljavanja.
njihovog preživljavanja.
03:35
Early on its development, they did a very small trial,
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Na početku njegovog razvoja,
uradili su veoma malu studiju,
uradili su veoma malu studiju,
03:38
just under a hundred patients.
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uključujući manje od sto pacijenata.
03:40
Fifty patients got lorcainide, and of those patients, 10 died.
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Pedeset pacijenata je dobilo
lorkainid i 10 je umrlo.
lorkainid i 10 je umrlo.
03:43
Another 50 patients got a dummy placebo sugar pill
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Drugih 50 je dobilo praznu
placebo zašećernu tabletu
placebo zašećernu tabletu
03:46
with no active ingredient, and only one of them died.
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bez aktivnog sastojka i samo jedan je umro.
03:49
So they rightly regarded this drug as a failure,
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Dakle, ispravno su zaključili da je lek neuspešan,
03:52
and its commercial development was stopped, and because
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njegov komercijalni razvoj je zaustavljen, a zbog tog
03:55
its commercial development was stopped, this trial was never published.
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zaustavljanja, ispitivanje nikad nije bilo objavljeno.
03:59
Unfortunately, over the course of the next five, 10 years,
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Nažalost, tokom narednih 5 godina, 10 godina,
04:04
other companies had the same idea about drugs that would
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druge kompanije su došle
na istu ideju o lekovima koji bi
na istu ideju o lekovima koji bi
04:08
prevent arrhythmias in people who have had heart attacks.
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sprečili aritmije kod ljudi koji su doživeli srčani udar.
04:11
These drugs were brought to market. They were prescribed
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Ovi lekovi su izašli na tržište.
Oni su prepisivani
Oni su prepisivani
04:13
very widely because heart attacks are a very common thing,
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dosta često jer su infarkti srca česti
04:16
and it took so long for us to find out that these drugs
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i trebalo nam je dosta vremena
da otkrijemo da ovi lekovi
da otkrijemo da ovi lekovi
04:20
also caused an increased rate of death
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takođe povećavaju smrtnost,
04:23
that before we detected that safety signal,
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tako da je, pre nego što smo otkrili
znak za uzbunu,
znak za uzbunu,
04:25
over 100,000 people died unnecessarily in America
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preko 100 000 ljudi u Americi
nepotrebno umrlo
nepotrebno umrlo
04:32
from the prescription of anti-arrhythmic drugs.
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zbog prepisivanja antiaritmika.
04:35
Now actually, in 1993,
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U stvari, 1993.
04:39
the researchers who did that 1980 study, that early study,
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istraživači koji su uradili studiju 1980.
- tu početnu studiju,
- tu početnu studiju,
04:42
published a mea culpa, an apology to the scientific community,
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objavili su je kao mea culpa,
izvinjenje naučnoj zajednici
izvinjenje naučnoj zajednici
04:46
in which they said, "When we carried out our study in 1980,
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u kom su izjavili:
“Kada smo radili studiju 1980.,
“Kada smo radili studiju 1980.,
04:49
we thought that the increased death rate that occurred
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mislili smo da je povećana smrtnost
04:51
in the lorcainide group was an effect of chance."
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u lorkainid grupi slučajnost.”
04:54
The development of lorcainide was abandoned for commercial reasons,
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Razvoj lorkainida je napušten
iz komercijalnih razloga
iz komercijalnih razloga
04:56
and this study was never published;
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i ova studija nikad nije objavljena;
04:58
it's now a good example of publication bias.
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sada je to dobar primer
pristrasnosti objavljivanja.
pristrasnosti objavljivanja.
05:00
That's the technical term for the phenomenon where
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To je tehnički izraz za pojavu kada
05:02
unflattering data gets lost, gets unpublished, is left
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neželjeni podaci budu izgubljeni,
ostanu neobjavljeni,
ostanu neobjavljeni,
05:07
missing in action, and they say the results described here
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izgube se u akciji i oni tvrde
da su ovde opisani rezultati
da su ovde opisani rezultati
05:10
"might have provided an early warning of trouble ahead."
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“mogli da obezbede rano upozorenje na problem”.
05:15
Now these are stories from basic science.
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Ovo su priče iz bazičnih nauka.
05:18
These are stories from 20, 30 years ago.
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Ovo su priče od pre 20, 30 godina.
05:23
The academic publishing environment is very different now.
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Naučno izdavačko okruženje je danas veoma različito.
05:26
There are academic journals like "Trials," the open access journal,
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Postoje naučni časopisi kao što je “Trials”,
časopis slobodnog pristupa,
časopis slobodnog pristupa,
05:30
which will publish any trial conducted in humans
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koji će objaviti svako ispitivanje
sprovedeno na ljudima
sprovedeno na ljudima
05:33
regardless of whether it has a positive or a negative result.
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nezavisno od toga da li je ishod
pozitivan ili negativan.
pozitivan ili negativan.
05:36
But this problem of negative results that go missing in action
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Ali ovaj problem negativnih rezultata
izgubljenih u akciji
izgubljenih u akciji
05:40
is still very prevalent. In fact it's so prevalent
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je i dalje veoma prisutan.
U stvari toliko je prisutan,
U stvari toliko je prisutan,
05:43
that it cuts to the core of evidence-based medicine.
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da je u samom centru medicine
koja je zasnovana na dokazima.
koja je zasnovana na dokazima.
05:49
So this is a drug called reboxetine, and this is a drug
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Ovo je lek nazvan reboksetin, taj lek
05:52
that I myself have prescribed. It's an antidepressant.
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sam i ja prepisivao.
On je antidepresiv.
On je antidepresiv.
05:55
And I'm a very nerdy doctor, so I read all of the studies
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Ja sam doktor štreber,
tako da sam pročitao sve moguće
tako da sam pročitao sve moguće
05:57
that I could on this drug. I read the one study that was published
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studije o ovom leku.
Pročitao sam jednu objavljenu studiju
Pročitao sam jednu objavljenu studiju
06:00
that showed that reboxetine was better than placebo,
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koja je pokazala da je reboksetin
bolji od placeba
bolji od placeba
06:03
and I read the other three studies that were published
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i još tri studije koje su objavljene,
06:05
that showed that reboxetine was just as good as any other antidepressant,
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a pokazale su da je dobar
koliko i drugi antidepresivi
koliko i drugi antidepresivi
06:09
and because this patient hadn't done well on those other antidepressants,
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i budući da ovaj pacijent nije dobro odreagovao
na druge antidepresive,
na druge antidepresive,
06:11
I thought, well, reboxetine is just as good. It's one to try.
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pomislio sam, reboksetin je jednako dobar.
Mogu da pokušam.
Mogu da pokušam.
06:13
But it turned out that I was misled. In fact,
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Ali se ispostavilo da sam bio obmanut.
U stvari,
U stvari,
06:17
seven trials were conducted comparing reboxetine
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sedam ispitivanja je sprovedeno
poredeći reboksetin
poredeći reboksetin
06:19
against a dummy placebo sugar pill. One of them
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sa lažnom placebo šećernom tabletom.
Jedna od njih
Jedna od njih
06:22
was positive and that was published, but six of them
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je bila pozitivna i ta je objavljena,
ali šest ostalih
ali šest ostalih
06:24
were negative and they were left unpublished.
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su bile negativne i nisu objavljene.
06:28
Three trials were published comparing reboxetine
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Objavljena su tri ispitivanja,
koja porede reboksetin
koja porede reboksetin
06:30
against other antidepressants in which reboxetine
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sa drugim antidepresivima,
u kojima je reboksetin
u kojima je reboksetin
06:32
was just as good, and they were published,
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podjednako dobar,
06:34
but three times as many patients' worth of data was collected
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ali tri puta više valjanih podataka
o pacijentima je sakupljeno,
o pacijentima je sakupljeno,
06:38
which showed that reboxetine was worse than
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a oni pokazuju da je reboksetin lošiji
06:40
those other treatments, and those trials were not published.
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od tih drugih lekova
i ova ispitivanja nisu objavljena.
i ova ispitivanja nisu objavljena.
06:45
I felt misled.
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Osećao sam se obmanuto.
06:49
Now you might say, well, that's an extremely unusual example,
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Sada vi možete reći, pa dobro,
to je veoma neobičan primer
to je veoma neobičan primer
06:51
and I wouldn't want to be guilty of the same kind of
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i ne bih želeo da budem kriv za istu vrstu
06:53
cherry-picking and selective referencing
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probiranja i selektivnog obaveštavanja
06:56
that I'm accusing other people of.
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za koje optužujem druge ljude.
06:58
But it turns out that this phenomenon of publication bias
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Ali proizlazi da je ova pojava
izdavačke pristrasnosti,
izdavačke pristrasnosti,
07:00
has actually been very, very well studied.
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zapravo bila veoma,
veoma dobro proučavana.
veoma dobro proučavana.
07:02
So here is one example of how you approach it.
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Ovde je jedan primer kako da joj pristupite.
07:04
The classic model is, you get a bunch of studies where
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Klasični model je, dobijete grupu studija za koje
07:06
you know that they've been conducted and completed,
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znate da su bile sprovedene i završene,
07:09
and then you go and see if they've been published anywhere
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a zatim proverite da li su igde objavljene
07:11
in the academic literature. So this took all of the trials
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u naučnoj literaturi.
Znači, ovim pristupom su uzeta
Znači, ovim pristupom su uzeta
07:14
that had ever been conducted on antidepressants
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sva ikad sprovedena ispitivanja o antidepresivima,
07:16
that were approved over a 15-year period by the FDA.
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a odobrila ih je FDA tokom 15 godina.
07:20
They took all of the trials which were submitted to the FDA as part of the approval package.
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Uzeli su sva ispitivanja koja su predata u FDA
kao deo paketa za saglasnost.
kao deo paketa za saglasnost.
07:23
So that's not all of the trials that were ever conducted on these drugs,
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Dakle, to nisu sva ispitivanja o ovim lekovima
koja su ikad sprovedena
koja su ikad sprovedena
07:26
because we can never know if we have those,
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jer nikad ne možemo znati da imamo sva ispitivanja,
07:29
but it is the ones that were conducted in order to get the marketing authorization.
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ali to su ona koja su sprovedena
da bi se dobila dozvola za proizvodnju.
da bi se dobila dozvola za proizvodnju.
07:32
And then they went to see if these trials had been published
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A zatim su proverili da li su ova ispitivanja objavljena
07:34
in the peer-reviewed academic literature. And this is what they found.
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u kritički pregledanoj naučnoj literaturi.
Ovo su pronašli.
Ovo su pronašli.
07:37
It was pretty much a 50-50 split. Half of these trials
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To je podela gotovo pola-pola.
Stvarno, polovina ovih
Stvarno, polovina ovih
07:40
were positive, half of them were negative, in reality.
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ispitivanja je bila pozitivna,
polovina negativna.
polovina negativna.
07:44
But when they went to look for these trials in the peer-reviewed academic literature,
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Ali kada su tražili ova ispitivanja
u naučnoj literaturi,
u naučnoj literaturi,
07:49
what they found was a very different picture.
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dobili su veoma različitu sliku.
07:51
Only three of the negative trials were published,
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Samo tri negativna ispitivanja su bila objavljena,
07:55
but all but one of the positive trials were published.
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ali sva pozitivna ispitivanja, izuzev jednog,
bila su objavljena.
bila su objavljena.
08:00
Now if we just flick back and forth between those two,
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Ako ih sada samo rasvetlimo
08:04
you can see what a staggering difference there was
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možete uvideti upadljivu razliku koja postoji
08:06
between reality and what doctors, patients,
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između stvarnosti i onoga što lekari, pacijenti,
08:10
commissioners of health services, and academics
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zastupnici zdravstvene službe i naučnici
08:12
were able to see in the peer-reviewed academic literature.
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mogu da vide u kritički pregledanoj naučnoj literaturi.
08:15
We were misled, and this is a systematic flaw
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Mi smo obmanuti i ovo je sistemska mana
08:20
in the core of medicine.
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u samoj srži medicine.
08:23
In fact, there have been so many studies conducted on
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U stvari, postojalo je veoma mnogo
studija urađenih o
studija urađenih o
08:26
publication bias now, over a hundred, that they've been
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pristrasnosti izdavaštva,
preko sto, tako da su one
preko sto, tako da su one
08:29
collected in a systematic review, published in 2010,
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sakupljene u sistematskom prikazu objavljenom 2010.
08:32
that took every single study on publication bias
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Uzeli su svaku studiju
o pristrasnosti izdavaštva
o pristrasnosti izdavaštva
08:35
that they could find.
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koju su mogli da pronađu.
08:37
Publication bias affects every field of medicine.
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Pristrasnost objavljivanja utiče
na svaki deo medicine.
na svaki deo medicine.
08:39
About half of all trials, on average, go missing in action,
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Prosečno oko polovina svih ispitivanja
se izgubi u akciji,
se izgubi u akciji,
08:44
and we know that positive findings are around twice as likely
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a mi znamo da će pozitivni nalazi biti dva puta
08:47
to be published as negative findings.
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češće objavljeni nego negativni.
08:50
This is a cancer at the core of evidence-based medicine.
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Ovo je rak u srži medicine zasnovane na dokazima.
08:54
If I flipped a coin 100 times but then
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Ukoliko 100 puta bacim novčić, ali zatim
08:58
withheld the results from you from half of those tosses,
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uskratim razultate polovine ovih bacanja,
09:01
I could make it look as if I had a coin that always came up heads.
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izgledalo bi da imam novčić
koji uvek pokazuje glavu.
koji uvek pokazuje glavu.
09:04
But that wouldn't mean that I had a two-headed coin.
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Ali ovo ne bi značilo da imam novčić sa dve glave.
09:06
That would mean that I was a chancer
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To bi značilo da sam oportunista,
09:08
and you were an idiot for letting me get away with it. (Laughter)
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i da ste vi glupi što ste mi dozvolili
da se sa tim izvučem. (Smeh)
da se sa tim izvučem. (Smeh)
09:11
But this is exactly what we blindly tolerate
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Ali ovo je upravo ono što slepo dopuštamo
09:15
in the whole of evidence-based medicine.
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u celokupnoj medicini zasnovanoj na dokazima.
09:19
And to me, this is research misconduct.
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Za mene, ovo je istraživački prestup.
09:23
If I conducted one study and I withheld
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Ukoliko sam sproveo jednu studiju i uskratio
09:26
half of the data points from that one study,
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polovinu podataka iz jedne studije,
09:29
you would rightly accuse me, essentially, of research fraud.
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vi biste me ispravno optužili
za istraživačku prevaru.
za istraživačku prevaru.
09:33
And yet, for some reason, if somebody conducts
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Ali iz nekog razloga ako neko sprovede
09:36
10 studies but only publishes the five that give the result that they want,
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10 studija, ali objavi samo pet
koje su dale rezultat koji su želeli,
koje su dale rezultat koji su želeli,
09:41
we don't consider that to be research misconduct.
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ne smatramo da je to istraživački prestup.
09:44
And when that responsibility is diffused between
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A kada se ta odgovornost raspline u
09:46
a whole network of researchers, academics,
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celoj mreži istraživača, naučnika,
09:49
industry sponsors, journal editors, for some reason
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privrednih sponzora, urednika časopisa,
iz nekog razloga
iz nekog razloga
09:53
we find it more acceptable,
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mislimo da je prihvatljivija,
09:54
but the effect on patients is damning.
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ali efekat je sudbinski za pacijente.
09:58
And this is happening right now, today.
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Ovo se upravo sada događa, danas.
10:03
This is a drug called Tamiflu. Tamiflu is a drug
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Ovo je lek nazvan Tamiflu.
Tamiflu je lek
Tamiflu je lek
10:06
which governments around the world have spent billions
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na koji su vlade sveta potrošile milijarde i
10:08
and billions of dollars on stockpiling,
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milijarde dolara da bi stvorili zalihe
10:11
and we've stockpiled Tamiflu in panic,
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i napravili smo zalihe Tamiflua u panici,
10:14
in the belief that it will reduce the rate of complications of influenza.
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verujući da će smanjiti učestalost
komplikacija gripa.
komplikacija gripa.
10:18
Complications is a medical euphemism for pneumonia
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Komplikacije su medicinski eufemizam
za upalu pluća
za upalu pluća
10:21
and death. (Laughter)
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i smrt.
(Smeh)
(Smeh)
10:25
Now when the Cochrane systematic reviewers
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Kada su istraživači Kokranove biblioteke
10:29
were trying to collect together all of the data from all
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pokušali da sakupe sve podatke
iz svih istraživanja
iz svih istraživanja
10:31
of the trials that had ever been conducted on whether Tamiflu actually did this or not,
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koja su ikad sprovedena radi provere
da li Tamiflu ima taj efekat ili ne,
da li Tamiflu ima taj efekat ili ne,
10:35
they found that several of those trials were unpublished.
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pronašli su da nekoliko ispitivanja nije objavljeno.
10:38
The results were unavailable to them.
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Ovi rezultati su im bili nedostupni.
10:40
And when they started obtaining the writeups of those trials through various different means,
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A kada su počeli da dolaze do zapisa iz ovih ispitivanja, različitim putevima,
10:44
through Freedom of Information Act requests, through
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preko Zakona o slobodi informacija,
10:45
harassing various different organizations, what they found was inconsistent.
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uznemiravanjem različitih organizacija,
našli su protivurečnosti.
našli su protivurečnosti.
10:50
And when they tried to get a hold of the clinical study reports,
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Kada su pokušali da uzmu izveštaje kliničkih studija,
10:52
the 10,000-page long documents that have
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to su dokumenti dugi 10 000 stranica koji
10:56
the best possible rendition of the information,
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sadrže najbolje predstavljene informacije,
10:59
they were told they weren't allowed to have them.
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rečeno im je da nemaju dozvolu za njih.
11:02
And if you want to read the full correspondence
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Ukoliko želite da pročitate potpunu prepisku,
11:05
and the excuses and the explanations given by the drug company,
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opravdanja i objašnjenja
koja je dala farmaceutska kompanija,
koja je dala farmaceutska kompanija,
11:08
you can see that written up in this week's edition
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možete da ih vidite u ovonedeljnom izdanju
11:11
of PLOS Medicine.
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časopisa PLOS Medicine.
11:15
And the most staggering thing of all of this, to me,
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Ono što mene od svega najviše zbunjuje je
11:19
is that not only is this a problem, not only do we recognize
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da ovo nije samo problem koji prepoznajemo
11:22
that this is a problem, but we've had to suffer fake fixes.
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nego što moramo da trpimo lažna rešenja.
11:26
We've had people pretend that this is a problem that's been fixed.
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Ljudi su se pretvarali da je ovaj problem rešen.
11:29
First of all, we had trials registers, and everybody said,
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Prvo, imali smo registar ispitivanja i svi su tvrdili
11:32
oh, it's okay. We'll get everyone to register their trials, they'll post the protocol,
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oh, to je dobro. Svako će prijaviti svoja ispitivanja,
poslaće protokol,
poslaće protokol,
11:35
they'll say what they're going to do before they do it,
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reći će šta će šta želi da uradi
pre nego što počne,
pre nego što počne,
11:37
and then afterwards we'll be able to check and see if all the trials which
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a posle ćemo moći da vidimo i proverimo
da li su sva sprovedena
da li su sva sprovedena
11:39
have been conducted and completed have been published.
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i završena ispitivanja objavljena.
11:42
But people didn't bother to use those registers.
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Ali, ljudi se nisu zamarali upotrebom tih registara.
11:44
And so then the International Committee of Medical Journal Editors came along,
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Zatim se pojavio Internacionalni odbor
urednika medicinskih časopisa
urednika medicinskih časopisa
11:47
and they said, oh, well, we will hold the line.
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koji je tvrdio da će oni biti čuvari.
11:48
We won't publish any journals, we won't publish any trials,
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"Nećemo objavljivati nijedan časopis
i nijedno ispitivanje
i nijedno ispitivanje
11:51
unless they've been registered before they began.
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ukoliko nije bilo prijavljeno
pre nego što je započeto."
pre nego što je započeto."
11:54
But they didn't hold the line. In 2008, a study was conducted
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Ali nisu izdržali.
2008. sprovedena je studija
2008. sprovedena je studija
11:57
which showed that half of all of trials published by journals
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koja je pokazala da polovina ispitivanja
objavljenih u časopisima,
objavljenih u časopisima,
12:00
edited by members of the ICMJE
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koje su uređivali članovi Odbora,
12:03
weren't properly registered, and a quarter of them weren't registered at all.
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nije bila pravilno prijavljena,
a četvrtina uopšte nije bila prijavljena.
a četvrtina uopšte nije bila prijavljena.
12:08
And then finally, the FDA Amendment Act was passed
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Konačno, pre nekoliko godina
12:10
a couple of years ago saying that everybody who conducts
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usvojen je FDA amandman
koji traži da svako ko sprovodi
koji traži da svako ko sprovodi
12:13
a trial must post the results of that trial within one year.
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ispitivanje mora da dostavi
rezultate u roku od godinu dana.
rezultate u roku od godinu dana.
12:16
And in the BMJ, in the first edition of January, 2012,
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U BMJ, u prvom izdanju iz januara 2012.,
12:20
you can see a study which looks to see if people kept
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možete da vidite studiju
koja proverava da li su se
koja proverava da li su se
12:23
to that ruling, and it turns out that only one in five
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istraživači pridržavali ove odluke i proizlazi da
12:27
have done so.
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samo jedan od pet jeste.
12:30
This is a disaster.
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Ovo je katastrofa.
12:33
We cannot know the true effects of the medicines
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Ne možemo da znamo prave efekte lekova
12:36
that we prescribe if we do not have access
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koje prepisujemo ako nemamo pristup
12:40
to all of the information.
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svim informacijama.
12:43
And this is not a difficult problem to fix.
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A ovaj problem nije teško rešiti.
12:47
We need to force people to publish all trials
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Moramo da nateramo istraživače
da objavljuju sva ispitivanja
da objavljuju sva ispitivanja
12:52
conducted in humans, including the older trials,
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sprovedena na ljudima,
uključujući i ranija ispitivanja
uključujući i ranija ispitivanja
12:55
because the FDA Amendment Act only asks that you publish the trials conducted after 2008,
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jer FDA amandman zahteva objavljivanje
ispitivanja samo posle 2008.
ispitivanja samo posle 2008.
12:59
and I don't know what world it is in which we're only
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Ne znam u kakvom svetu živimo, ako
13:01
practicing medicine on the basis of trials that completed in the past two years.
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lečimo samo na osnovu ispitivanja završenih
u poslednje dve godine.
u poslednje dve godine.
13:06
We need to publish all trials in humans,
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Moramo da objavimo sva ispitivanja na ljudima,
13:08
including the older trials, for all drugs in current use,
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uključujući starija ispitivanja,
za sve lekove koji se sad koriste
za sve lekove koji se sad koriste
13:11
and you need to tell everyone you know
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i morate da obavestite sve koje poznajete
13:14
that this is a problem and that it has not been fixed.
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da je ovo problem i da nije rešen.
13:17
Thank you very much. (Applause)
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Hvala vam mnogo.
(Aplauz)
(Aplauz)
13:20
(Applause)
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(Aplauz)
ABOUT THE SPEAKER
Ben Goldacre - DebunkerBen Goldacre unpicks dodgy scientific claims made by scaremongering journalists, dubious government reports, pharmaceutical corporations, PR companies and quacks.
Why you should listen
"It was the MMR story that finally made me crack," begins the Bad Science manifesto, referring to the sensationalized -- and now-refuted -- link between vaccines and autism. With that sentence Ben Goldacre fired the starting shot of a crusade waged from the pages of The Guardian from 2003 to 2011, on an addicitve Twitter feed, and in bestselling books, including Bad Science and his latest, Bad Pharma, which puts the $600 billion global pharmaceutical industry under the microscope. What he reveals is a fascinating, terrifying mess.
Goldacre was trained in medicine at Oxford and London, and works as an academic in epidemiology. Helped along by this inexhaustible supply of material, he also travels the speaking circuit, promoting skepticism and nerdish curiosity with fire, wit, fast delivery and a lovable kind of exasperation. (He might even convince you that real science, sober reporting and reason are going to win in the end.)
As he writes, "If you're a journalist who misrepresents science for the sake of a headline, a politician more interested in spin than evidence, or an advertiser who loves pictures of molecules in little white coats, then beware: your days are numbered."
Ben Goldacre | Speaker | TED.com