Die
Cochrane Collaboration – Ein sinkendes Schiff?
Professor
Peter Gøtzsche ist der Leiter des nordischen Cochrane Centers
in Kopenhagen und ein bekannter Publizist (z. B. „Deadly
Medicines and Organised Crime: How Big Pharma has Corrupted
Healthcare”).
Seine Meinungen sind mitunter polarisierend, oft sehr radikal –
ebenso wie auch sein Diskussionsstil. Aber der wissenschaftliche und
politische Diskurs lebt ja auch von extremen Positionen, wenn sie gut
begründet sind.
Bis
vergangene Woche war Peter Gøtzsche auch im Vorstand der
Internationalen Cochrane Collaboration, die ein sehr hohes Ansehen
bei Verfechtern der evidenzbasierten Medizin genießt. Dieses
Ansehen basiert auf einer sauberen wissenschaftlichen Methodologie
und auf Unabhängigkeit.
An
dem Cochrane Review zur HPV-Impfung aus dem Mai entzündete sich
nun ein scheinbar unüberbrückbarer Streit innerhalb des
Vorstandes, an dessen vorläufigem Ende die Abwahl von Gøtzsche
aus dem Vorstand der Internationalen Cochrane Collaboration und der
solidarische Rücktritt von vier weiteren Vorstandsmitgliedern
stand.
Gøtzsche
und sein Koautor Jørgensen kritisierten an dem Cochrane Review
zur HPV-Impfung in einem Artikel im British Medical Journal schwere
methodische Mängel. Außerdem weisen sie ausdrücklich
auf relevante Interessenkonflikte des Hauptautors und der Reviewer
hin, die das Urteil des Reviews beeinflusst haben könnten
(https://www.bmj.com/content/362/bmj.k3945/rr-0).
Der
Vorstand der International Society of Drug Bulletins (ISDB), in der
auch DER ARZNEIMITTRELBRIEF Mitglied ist, hat zu diesen Vorgängen
nun eine Stellungnahme verfasst, die wir an dieser Stelle
veröffentlichen wollen:
Cochrane’s
sinking ship and conflicts of interest.
We
believe Cochrane is a key source of scientific evidence on diagnostic
and therapeutic medical issues. The very recent expulsion of Peter
Gøtzsche from the Cochrane Board and subsequent retirement of
four Board members have great impact on the existence of this
organisation. Beside issues mentioned by other authors1-3
we believe this crisis is a good opportunity to fix a big problem
raised by Peter Gøtzsche and others about Cochrane’s
conflict of interest policy.
Currently,
Cochrane allows some authors of its reviews to have conflicts of
interest with drug companies, a policy that is widely criticized by
insiders, and largely unknown to the public.
It
is well known that researchers with conflicts of interest judge more
positively about drug therapies than researchers without such ties.
Gøtzsche said that Cochrane’s policy regarding conflicts
of interest of authors of reviews was inadequate. But Cochrane did
not solve this problem. The
International Society of Drug Bulletins (ISDB) has criticized this
policy already in 2013.4
Because
organisations like Cochrane play a key role in assessing clinical
trials and other evidence regarding medicines, it is essential that
they have robust policies with regard to conflicts of interest.
The
International Society of Drug Bulletins (ISDB) is a worldwide network
of bulletins and journals on drugs and therapeutics that are
financially and intellectually independent of the pharmaceutical
industry.5
Cochrane reviews have been considered important scientific and
trustworthy references for ISDB members.
In
2016 ISDB adopted a policy that will be totally implemented in 2019,
in which members are not allowed to have conflicts of interest with
the healthcare industry. Those who have not fulfilled the criteria
will be removed from the full membership list.
A
Conflict
of interest
is defined as any financial or advisory relationship (paid or unpaid)
with the pharmaceutical industry or related healthcare industry (e.g.
medical devices or diagnostics), including the conduct of industry
funded clinical trials. Members of the editorial team must be free
from conflicts of interest with these industries. All authors who
write articles which could influence therapeutic choices (e.g. drug
and treatment reviews or guidelines) must be free from conflicts of
interest.
What
is at stake is the not the transparency of conflicts of interest or
whether or not it is feasible to get rid of conflicts of interest it
is definitely about trust,
credibility and scientific integrity.6
Cochrane
is damaging the trust and credibility doctors, pharmacists,
scientists and patients have put in them. Cochrane’s
credibility and trust are largely at stake if they do not adequately
deal with this issue immediately.
ISDB
therefore supports Gøtzsche’s claim that a recovery from
this dire situation would call for the dissolution of the present
board, new elections and a broad-based participatory debate about the
future strategy and governance of the organisation.
Dick
Bijl, president International Society of Drug Bulletins (ISDB),
on
behalf of the ISDB Committee: Luis Carlos Saiz Fernandez, Maria Font,
Ciprian Jauca, Christophe Kopp, Benito Marchand, Joerg Schaaber.
1.
Demasi M. Cochrane – A sinking ship?
https://blogs.bmj.com/bmjebmspotlight/2018/09/16/cochrane-a-sinking-ship/
2.
Greenhalgh
T. The Cochrane Collaboration – what crisis?
https://blogs.bmj.com/bmj/2018/09/17/trish-greenhalgh-the-cochrane-collaboration-what-crisis/
3.
Moynihan R. Let’s
stop the burning and the bleeding at Cochrane — there’s
too much at stake.
https://blogs.bmj.com/bmj/2018/09/17/ray-moynihan-lets-stop-the-burning-and-the-bleeding-at-cochrane-theres-too-much-at-stake/
4.
Schaaber J. Cochrane under influence: assessment of the HPV vaccines
and conflict of interest. ISDB Newsletter 2013;2:8.
5.
www.isdbweb.org
6.
Menkes D, Bijl D. Credibility and trust are required to judge the
benefits and harms of medicines. BMJ 2017;358:j4204.