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TEDMED 2012

Ben Goldacre: What doctors don't know about the drugs they prescribe

ベン・ゴールドエイカー: 医者も知らない薬の秘密

June 5, 2012

新薬の治験の際には結果は医学界の皆のために公開されるべきです。しかし否定的だったり結論が出ないという結果はわずかな例外を除いて報告されずじまいとなり、医師や研究者は闇に取りのこされます。この情熱的なトークでベン・ゴールドエイカーは、これらの否定的なデータが公開されなかった例が、いかに危険で判断を誤らせるものかを説明します。

Ben Goldacre - Debunker
Ben Goldacre unpicks dodgy scientific claims made by scaremongering journalists, dubious government reports, pharmaceutical corporations, PR companies and quacks. Full bio

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Double-click the English subtitles below to play the video.
Hi. So, this chap here,
さてこの男は 自分には
00:16
he thinks he can tell you the future.
未来のことがわかると考えていました
00:18
His name is Nostradamus, although here the Sun have
ノストラダムスです
00:21
made him look a little bit like Sean Connery. (Laughter)
サン紙では ショーン・コネリーのように見えますね (笑)
00:23
And like most of you, I suspect, I don't really believe
大半の人と同じく 私も未来のことがわかるとは思いません
00:26
that people can see into the future.
大半の人と同じく 私も未来のことがわかるとは思いません
00:29
I don't believe in precognition, and every now and then,
予知は信じません ときおり 誰かが
00:30
you hear that somebody has been able to predict something that happened in the future,
未来を予知していたという話もありますが
00:33
and that's probably because it was a fluke, and we only
それはまぐれ当たりでしょう
00:36
hear about the flukes and about the freaks.
まぐれとか極端な話だけが話題になり
00:39
We don't hear about all the times that people got stuff wrong.
失敗した場合については話題にならないのです
00:42
Now we expect that to happen with silly stories
予言のようなどうでもいい話は
00:46
about precognition, but the problem is,
そんなものでしょう
しかし困ったことに
00:48
we have exactly the same problem in academia
全く同じ問題が学術や医学の世界にも はびこっており
00:51
and in medicine, and in this environment, it costs lives.
時として命にも関わる問題になっているのです
00:54
So firstly, thinking just about precognition, as it turns out,
最初に 予言の話だけを考えてみます
00:59
just last year a researcher called Daryl Bem conducted
つい昨年 ダリル・ベンという研究者が
01:02
a piece of research where he found evidence
つい昨年 ダリル・ベンという研究者が
01:05
of precognitive powers in undergraduate students,
学生達に予知能力があると証明する研究をまとめ
01:07
and this was published in a peer-reviewed academic journal
査読付きの学術論文として掲載されたことがわかりました
01:10
and most of the people who read this just said, "Okay, well,
読者の大半の反応です
01:13
fair enough, but I think that's a fluke, that's a freak, because I know
「なるほど でもまぐれか例外だろう
01:15
that if I did a study where I found no evidence
学生達に予知能力があるという
01:17
that undergraduate students had precognitive powers,
証拠が得られなかったという研究だったら
01:20
it probably wouldn't get published in a journal.
論文誌に載らないことは明らかなんだから」
01:23
And in fact, we know that that's true, because
そして まさにそのとおりだと判っています
01:26
several different groups of research scientists tried
別の複数のグループが
01:29
to replicate the findings of this precognition study,
この予知の実験結果を再現しようと試みて
01:32
and when they submitted it to the exact same journal,
同じ学術誌に投稿したときに
01:35
the journal said, "No, we're not interested in publishing
その雑誌からは「反復実験に興味はありません
01:38
replication. We're not interested in your negative data."
ネガティブデータに興味はございません」と言われたのです
01:41
So this is already evidence of how, in the academic
この例は 学術誌において
01:46
literature, we will see a biased sample of the true picture
我々が目にする姿と
実際に行われた科学的研究の全体像とが
01:48
of all of the scientific studies that have been conducted.
ずれていることの証拠です
01:53
But it doesn't just happen in the dry academic field of psychology.
心理学という生死に関わらない学術分野だけの
問題ではありません
01:57
It also happens in, for example, cancer research.
例えば癌の研究でも同じ問題が起きます
02:01
So in March, 2012, just one month ago, some researchers
ほんの一ヶ月前の2012年3月に
02:05
reported in the journal Nature how they had tried
ネイチャー誌に出た報告です
02:09
to replicate 53 different basic science studies looking at
癌の治療ターゲット候補に関する53件の基礎研究の
02:12
potential treatment targets in cancer,
再現を試みた研究ですが
02:16
and out of those 53 studies, they were only able
53件のうち 再現できたのは
02:20
to successfully replicate six.
わずか6件でした
02:22
Forty-seven out of those 53 were unreplicable.
53件中47件は再現できなかったのです
02:26
And they say in their discussion that this is very likely
おそらく 特異的な結果が論文にされるので
02:30
because freaks get published.
こうなるのだろうと論じられています
02:34
People will do lots and lots and lots of different studies,
よってたかってたくさんの研究をして
02:36
and the occasions when it works they will publish,
うまくいった研究は公表され
02:38
and the ones where it doesn't work they won't.
失敗すると公表されません
02:41
And their first recommendation of how to fix this problem,
この問題に対処するため こんな提案がされています
02:42
because it is a problem, because it sends us all down blind alleys,
これは問題であり
行き止まりの袋小路に至る問題だからです
02:46
their first recommendation of how to fix this problem
この問題を回避するために
02:50
is to make it easier to publish negative results in science,
科学的に失敗した結果の公表を簡単にすることに加え
02:51
and to change the incentives so that scientists are
科学者にネガティブデータの公表を奨励するような
02:55
encouraged to post more of their negative results in public.
インセンティブを与えるべきだと
提案されています
02:58
But it doesn't just happen in the very dry world
さらに この問題は癌の基礎研究という
03:02
of preclinical basic science cancer research.
治験前の基礎研究のみならず
03:06
It also happens in the very real, flesh and blood
さらに生々しく肉と血を相手にする医療の学術分野でも
03:10
of academic medicine. So in 1980,
起きる問題です
1980年に
03:13
some researchers did a study on a drug called lorcainide,
ロルカイニドと呼ばれる抗不整脈剤の
03:17
and this was an anti-arrhythmic drug,
研究が行われました
03:20
a drug that suppresses abnormal heart rhythms,
心拍の異常を抑える薬です
03:22
and the idea was, after people have had a heart attack,
心臓発作のあとに
03:24
they're quite likely to have abnormal heart rhythms,
不整脈が現われることが多いので
03:27
so if we give them a drug that suppresses abnormal heart
抗不整脈剤を投与すれば
03:28
rhythms, this will increase the chances of them surviving.
生存率が向上するだろうという考えです
03:31
Early on its development, they did a very small trial,
開発初期に極めて小規模の治験を行い
03:34
just under a hundred patients.
100人の患者を対象にしました
03:37
Fifty patients got lorcainide, and of those patients, 10 died.
50人にロルカイニドを投与し 10人が死亡しました
03:39
Another 50 patients got a dummy placebo sugar pill
残りの50人には薬効成分を含まない砂糖でできた
03:43
with no active ingredient, and only one of them died.
偽薬を投与し 死亡したのは一人でした
03:46
So they rightly regarded this drug as a failure,
研究者たちは この薬は駄目だと直ちに判断し
03:49
and its commercial development was stopped, and because
新薬開発は中止されました
03:51
its commercial development was stopped, this trial was never published.
新薬開発は中止されたので
治験の結果は公表されませんでした
03:54
Unfortunately, over the course of the next five, 10 years,
不幸にして その後五年 十年のうちに
03:58
other companies had the same idea about drugs that would
他の会社も同じように
心臓発作の後に投与する
04:04
prevent arrhythmias in people who have had heart attacks.
抗不整脈剤のことを考えついたのです
04:08
These drugs were brought to market. They were prescribed
これらの薬は上市され
04:10
very widely because heart attacks are a very common thing,
何しろ心臓発作は多いだけに
たくさん処方されました
04:12
and it took so long for us to find out that these drugs
これらの上市された薬もまた
死亡率を高めてしまうことが
04:15
also caused an increased rate of death
判明するまでには長い時間がかかったので
04:19
that before we detected that safety signal,
その赤信号に気付くまでに
04:22
over 100,000 people died unnecessarily in America
アメリカでは死ななくてよかったはずの人が
10万人以上も亡くなりました
04:25
from the prescription of anti-arrhythmic drugs.
抗不整脈剤を処方されたための死者です
04:31
Now actually, in 1993,
さて1993年になると
04:34
the researchers who did that 1980 study, that early study,
1980年に初期の研究をした研究チームは
04:38
published a mea culpa, an apology to the scientific community,
科学界への告解文というべき論文でこう述べています
04:42
in which they said, "When we carried out our study in 1980,
「1980年に我々の研究を行ったときに
04:45
we thought that the increased death rate that occurred
ロルカイニドを投与した群における
04:49
in the lorcainide group was an effect of chance."
死亡率上昇は偶然のものと考えていた
04:50
The development of lorcainide was abandoned for commercial reasons,
ロルカイニドの開発は事業判断により中止され
結果は公にならなかった」
04:54
and this study was never published;
ロルカイニドの開発は事業判断により中止され
結果は公にならなかった」
04:56
it's now a good example of publication bias.
これは「公表バイアス」のわかりやすい例です
04:57
That's the technical term for the phenomenon where
この専門用語は
05:00
unflattering data gets lost, gets unpublished, is left
嬉しくないデータが失われたり 公表も
05:02
missing in action, and they say the results described here
対応もされずに放置される現象を示します
05:06
"might have provided an early warning of trouble ahead."
論文には「後から生じた問題は
早期に警告できるはずだった」と書かれています
05:09
Now these are stories from basic science.
ここまでの話は20−30年前の
05:14
These are stories from 20, 30 years ago.
基礎科学におけるエピソードでした
05:17
The academic publishing environment is very different now.
今では学術出版の環境もすっかり変わりました
05:22
There are academic journals like "Trials," the open access journal,
オープンアクセスの「トライアル」のような学術誌は
05:25
which will publish any trial conducted in humans
結果のいかんを問わず人間を対象とした治験を
05:29
regardless of whether it has a positive or a negative result.
掲載しようという方針です
05:32
But this problem of negative results that go missing in action
それでも否定的な結果が失われがちという問題は
05:35
is still very prevalent. In fact it's so prevalent
やはり広く見られるものであり
05:39
that it cuts to the core of evidence-based medicine.
「根拠に基づいた医療」の中核にかかわる問題です
05:43
So this is a drug called reboxetine, and this is a drug
これはレボキセチンという薬で
05:49
that I myself have prescribed. It's an antidepressant.
私も処方したことがある抗うつ剤です
05:52
And I'm a very nerdy doctor, so I read all of the studies
オタク気味の医者なので この薬に関して
05:54
that I could on this drug. I read the one study that was published
読みうる全ての論文を読みました
レボキセチンは
05:57
that showed that reboxetine was better than placebo,
偽薬よりも良いと示す論文を1本 そして
06:00
and I read the other three studies that were published
別の3つの論文ではレボキセチンは
06:03
that showed that reboxetine was just as good as any other antidepressant,
他の抗うつ剤と同等の効果を認められていました
06:05
and because this patient hadn't done well on those other antidepressants,
私の患者には他の薬は効かなかったので
06:08
I thought, well, reboxetine is just as good. It's one to try.
レボキセチンが同等というなら試すべきだと考えました
06:10
But it turned out that I was misled. In fact,
それは誤った判断とわかりました
実際は
06:13
seven trials were conducted comparing reboxetine
砂糖で作った偽薬とレボキセチンとの
06:16
against a dummy placebo sugar pill. One of them
治験は7つ行われ
そのうち1つの治験では
06:19
was positive and that was published, but six of them
効果が認められ論文となりました
06:21
were negative and they were left unpublished.
他の6つの治験では否定的な結果となり
公開されないまま終わったのです
06:24
Three trials were published comparing reboxetine
レボキセチンと他の抗うつ剤を比較した—
06:28
against other antidepressants in which reboxetine
3つの治験が公開され 同等の効果が
06:29
was just as good, and they were published,
認められていますが
06:32
but three times as many patients' worth of data was collected
その3倍もの患者数を調べ レボキセチンは
他の抗うつ剤よりも劣るとわかったのに
06:34
which showed that reboxetine was worse than
その3倍もの患者数を調べ レボキセチンは
他の抗うつ剤よりも劣るとわかったのに
06:38
those other treatments, and those trials were not published.
これらの処置や治験については論文になりませんでした
06:40
I felt misled.
私は誤った判断に導かれたようです
06:44
Now you might say, well, that's an extremely unusual example,
極端に例外的なケースと
06:48
and I wouldn't want to be guilty of the same kind of
思われるかもしれません
06:50
cherry-picking and selective referencing
今 問題にしている人たちのように都合のいいデータを
06:52
that I'm accusing other people of.
選ぶようなことを 私はしたくありません
06:55
But it turns out that this phenomenon of publication bias
結局 公表バイアスという現象は
06:57
has actually been very, very well studied.
これまで大いに研究されてきたものです
06:59
So here is one example of how you approach it.
たとえばこんなふうに調べます
07:01
The classic model is, you get a bunch of studies where
古典的モデルですが 実施されて
07:03
you know that they've been conducted and completed,
完了した治験を集めて
07:06
and then you go and see if they've been published anywhere
これがどこかの学術雑誌に
07:08
in the academic literature. So this took all of the trials
出版されているかどうかを調べます
さてここに示すのは
07:10
that had ever been conducted on antidepressants
この15年間に FDA が承認した
07:13
that were approved over a 15-year period by the FDA.
抗うつ薬の治験の全てです
07:15
They took all of the trials which were submitted to the FDA as part of the approval package.
承認手続きの一環としてFDAに
提出された治験を集めたのです
07:19
So that's not all of the trials that were ever conducted on these drugs,
実際にどれだけの治験が行われたかを
知ることはできないので
07:23
because we can never know if we have those,
全てが網羅されているとは限りませんが
07:26
but it is the ones that were conducted in order to get the marketing authorization.
製品を承認させるために行われた治験なのです
07:28
And then they went to see if these trials had been published
さてこれらの治験について
査読付学術誌での出版状況を
07:32
in the peer-reviewed academic literature. And this is what they found.
調べたところ
こんなことがわかりました
07:34
It was pretty much a 50-50 split. Half of these trials
治験の成績は五分五分で
治験の半分は成功
07:36
were positive, half of them were negative, in reality.
半分は否定的な結果というのが実状でしたが
07:40
But when they went to look for these trials in the peer-reviewed academic literature,
これらの治験についての査読付き論文を探してみると
07:43
what they found was a very different picture.
違う描像が浮かび上がってきます
07:48
Only three of the negative trials were published,
否定的な治験で論文公開されているのはわずか3報です
07:50
but all but one of the positive trials were published.
肯定的な治験は1件を除いて全て論文公開されています
07:55
Now if we just flick back and forth between those two,
この2つの結果をよく見比べると
07:59
you can see what a staggering difference there was
驚愕すべき違いがわかります
08:03
between reality and what doctors, patients,
医師や患者や
08:06
commissioners of health services, and academics
健康保険の理事や学会の人々が
08:09
were able to see in the peer-reviewed academic literature.
査読付き論文誌を通して知る姿と現実との間のギャップです
08:12
We were misled, and this is a systematic flaw
我々は誤った判断に導かれます
08:15
in the core of medicine.
これは医学の根本にあるシステム的な欠陥です
08:19
In fact, there have been so many studies conducted on
実際 公開バイアスに関してはこれまでに100件以上の
08:23
publication bias now, over a hundred, that they've been
研究が行われてきましたが
08:25
collected in a systematic review, published in 2010,
さらにその体系的なレビューが2010年に出版されました
08:29
that took every single study on publication bias
公開バイアスに関してのあらゆる研究を
08:32
that they could find.
取扱ったものです
08:35
Publication bias affects every field of medicine.
公開バイアスは医学のあらゆる領域に影響しています
08:36
About half of all trials, on average, go missing in action,
平均すると 全ての治験のうち半分がやりっぱなしで失われ
08:39
and we know that positive findings are around twice as likely
肯定的な結果が論文になる割合は
08:43
to be published as negative findings.
否定的な結果の2倍となるとわかりました
08:46
This is a cancer at the core of evidence-based medicine.
これは根拠に基づく医学の根本におけるガンです
08:49
If I flipped a coin 100 times but then
私がコインを100回投げてそれから
08:53
withheld the results from you from half of those tosses,
その結果の半分を隠すことをしたら
08:57
I could make it look as if I had a coin that always came up heads.
いつも表の出るコインを持っていると
思わせることができますが
09:00
But that wouldn't mean that I had a two-headed coin.
実際は違っています
09:04
That would mean that I was a chancer
私はペテン師で
09:06
and you were an idiot for letting me get away with it. (Laughter)
いんちきを許す皆さんがアホなのです(笑)
09:07
But this is exactly what we blindly tolerate
でもこれが根拠に基づく医療において
09:11
in the whole of evidence-based medicine.
見過ごされていることです
09:14
And to me, this is research misconduct.
私見ですが 不適切な研究とも言えます
09:18
If I conducted one study and I withheld
一つの研究として行った中で データの半分を
09:22
half of the data points from that one study,
隠してしまったら
09:25
you would rightly accuse me, essentially, of research fraud.
間違いなく不正な研究として非難されます
09:28
And yet, for some reason, if somebody conducts
しかしながら 理由はともあれ
10件の研究を行い
09:33
10 studies but only publishes the five that give the result that they want,
自分の望む結果の得られた5件だけを論文にする人がいても
09:36
we don't consider that to be research misconduct.
これを不正な研究とは呼ばないのです
09:40
And when that responsibility is diffused between
さらに その責任は
09:43
a whole network of researchers, academics,
研究者全体のネットワークや学会や
09:46
industry sponsors, journal editors, for some reason
支援する企業や 学術誌の編集者までにわたって
希薄に広がり 許容されがちです
09:49
we find it more acceptable,
支援する企業や 学術誌の編集者までにわたって
希薄に広がり 許容されがちです
09:52
but the effect on patients is damning.
しかし 患者に及ぼされた影響こそが
逃れようもない証拠です
09:54
And this is happening right now, today.
影響は今まさに生じていることなのです
09:57
This is a drug called Tamiflu. Tamiflu is a drug
この薬はタミフルです
10:02
which governments around the world have spent billions
世界中の政府が何十億ドルもかけて
10:05
and billions of dollars on stockpiling,
タミフルを備蓄してきました
10:08
and we've stockpiled Tamiflu in panic,
パニックに陥ったように競って備蓄してきました
10:10
in the belief that it will reduce the rate of complications of influenza.
この薬がインフルエンザ合併症の割合を
低減するだろうと信じたのです
10:13
Complications is a medical euphemism for pneumonia
合併症というのは医学的な婉曲表現で肺炎と
10:17
and death. (Laughter)
死亡のことです(笑)
10:20
Now when the Cochrane systematic reviewers
さてコクランの体系的レビュアーが
10:25
were trying to collect together all of the data from all
タミフルが合併症を抑えるかどうかという
10:28
of the trials that had ever been conducted on whether Tamiflu actually did this or not,
治験の全てのデータを収集しようとしたとき
10:31
they found that several of those trials were unpublished.
いくつかの治験の結果が
公表されていないことがわかりました
10:34
The results were unavailable to them.
レビュアーは結果を入手できないのです
10:37
And when they started obtaining the writeups of those trials through various different means,
別の様々なルートを通じて詳細記録を集め始めましたが
10:39
through Freedom of Information Act requests, through
情報公開法に基づいたり
10:43
harassing various different organizations, what they found was inconsistent.
いくつもの組織に嫌がられながら集めたデータは
整合しませんでした
10:45
And when they tried to get a hold of the clinical study reports,
そして臨床研究の報告書を入手しようとしたとき
10:49
the 10,000-page long documents that have
その文書は1万ページにもわたって
10:52
the best possible rendition of the information,
この研究についての最良の記述をしているのに
10:55
they were told they weren't allowed to have them.
これは渡せないと言われました
10:59
And if you want to read the full correspondence
このやりとりの全てと
11:01
and the excuses and the explanations given by the drug company,
製薬会社による弁解と説明にご興味があれば
11:04
you can see that written up in this week's edition
全ては今週の PLOS メディスンに
11:07
of PLOS Medicine.
掲載されています
11:10
And the most staggering thing of all of this, to me,
この中で私を何よりも愕然とさせたのは
11:15
is that not only is this a problem, not only do we recognize
このことが問題だったことに留まらず
11:18
that this is a problem, but we've had to suffer fake fixes.
これが問題だとわかってなお
偽りの対策でごまかされていることです
11:22
We've had people pretend that this is a problem that's been fixed.
この問題は解決済みだというふりをする人がいるのです
11:26
First of all, we had trials registers, and everybody said,
最初に 治験を申請するときには口を揃えて
11:29
oh, it's okay. We'll get everyone to register their trials, they'll post the protocol,
治験参加者全員に登録させ
実施要綱も公開させると言います
11:31
they'll say what they're going to do before they do it,
申請時に言っていたとおりであれば
11:35
and then afterwards we'll be able to check and see if all the trials which
実施して完了した全ての治験が
11:37
have been conducted and completed have been published.
出版されたかどうかは
後から誰でも確認できますが
11:39
But people didn't bother to use those registers.
実際にはきちんと登録されていなかったのです
11:41
And so then the International Committee of Medical Journal Editors came along,
ここで国際医学雑誌編集者委員会(ICMJE)が登場し
11:44
and they said, oh, well, we will hold the line.
我々が方針を定めよう
11:46
We won't publish any journals, we won't publish any trials,
開始前に登録されなかった治験や論文誌には
11:48
unless they've been registered before they began.
出版させないことにしようと言いました
11:50
But they didn't hold the line. In 2008, a study was conducted
でもその方針は守られませんでした
2008年に行われた研究によれば
11:53
which showed that half of all of trials published by journals
ICMJE 会員が編集する学術誌に掲載された
11:57
edited by members of the ICMJE
治験の半分は 登録が不適切で
12:00
weren't properly registered, and a quarter of them weren't registered at all.
4分の1はそもそも登録されていなかったことがわかりました
12:02
And then finally, the FDA Amendment Act was passed
そしてようやく FDA 改正法が成立しました
12:07
a couple of years ago saying that everybody who conducts
数年前のことです
治験を行うものは誰でも
12:10
a trial must post the results of that trial within one year.
その治験の結果を1年以内に投稿せよと規定しています
12:12
And in the BMJ, in the first edition of January, 2012,
BMJ の2012年1月号には
12:16
you can see a study which looks to see if people kept
この規定が守られているかどうかの調査が掲載され
12:20
to that ruling, and it turns out that only one in five
ルールに従っていたのは5件に1件に過ぎないことが
12:22
have done so.
明らかになりました
12:26
This is a disaster.
ひどい状況です
12:29
We cannot know the true effects of the medicines
全ての情報にアクセスできないようでは
12:32
that we prescribe if we do not have access
処方する薬の効果について本当のところを
12:36
to all of the information.
知ることができません
12:39
And this is not a difficult problem to fix.
この問題を解決するのは難しいことではありません
12:42
We need to force people to publish all trials
ヒトを対象とした全ての治験について
12:46
conducted in humans, including the older trials,
古いものも含めて公表させる必要があります
12:51
because the FDA Amendment Act only asks that you publish the trials conducted after 2008,
FDA 改正法は 2008年以降の治験に対してのみ
公開を求めています
12:54
and I don't know what world it is in which we're only
医療を実践するのに
12:58
practicing medicine on the basis of trials that completed in the past two years.
過去2年の治験のみを参照することなどありえません
13:01
We need to publish all trials in humans,
ヒトに対する治験全てを遡って
13:05
including the older trials, for all drugs in current use,
現在使用されている全ての薬を対象にして
公開する必要があります
13:07
and you need to tell everyone you know
この問題のこと それが未解決であることを
13:10
that this is a problem and that it has not been fixed.
どうか広く伝えて下さい
13:13
Thank you very much. (Applause)
ありがとうございます(拍手)
13:17
(Applause)
(拍手)
13:20
Translator:Natsuhiko Mizutani
Reviewer:Tomoshige Ohno

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