HALF A MILLION DOWNLOADS REACHED - Helping Safeguard children from psychiatric drug harm due to possible severe toxic side effects. We need alternatives like psychological interventions, physical activity, or mindfulness training as a first course of action. Let's 'Enable not Label' kids to give them better futures - - - - - - - - -"There can be no keener examination of a society's soul than the way it chooses to treat its children." - - - - -
- Nelson Mandela
Nordic Cochrane Centre, Rigshospitalet, Copenhagen
21 June 2013
EMA should continue its new openness policy despite current lawsuits
To Guido Rasi, Executive Director of the EMA
Nordic Cochrane Centre has for more than a year now received clinical study
reports and protocols from the EMA for duloxetine, an anti-depressant drug
marketed by Eli Lilly. These reports have been highly valuable for our research
and will also benefit public health, as they are more comprehensive and less
biased than what Eli Lilly has published in medical journals.
are continuing our research in this area but the EMA wrote to us on 17 June
2013 that we cannot get the remaining reports on duloxetine:
Agency's Policy has not been the object of detailed analysis by the President
of the General Court. However, in light of the on-going legal proceedings, in
particular, the Court's consideration of whether disclosure of the sort
documents you have requested might undermine the commercial interests of a
natural or legal person as laid down in Article 4(2) of Regulation (EC) No
1049/2001, please be informed that the Agency cannot grant access to the
note that the current cases at the General Court of the European Union do not
involve duloxetine or Eli Lilly but two other companies, AbbVie and Intermune,
and concern biologicals.
we asked the EMA in 2007 to share the clinical study reports and protocols for
orlistat, an anti-obesity drug, with us, our request was turned down by the
EMA's former director, Thomas Lönngren. We appealed Lönngren's decision to the
European ombudsman who inspected the reports we requested and concluded that
they did not contain commercially confidential information (1). After the ombudsman
had criticised the EMA for its decision, we were granted access in 2010. This
case is the basis for the EMA's new openness policy, which we wholeheartedly
support, as it will lead to tremendous progress in public health, less harm
caused by drugs, and economic savings for the European Union.
believe we are now at a watershed. The public's confidence in the drug
industry's working practices has never been lower, and it is clear that the
business model of big pharma is organised crime, which is immensely harmful to
our citizens (2). It is also true that drugs are the third leading cause of
death in Europe and the United States, after heart disease and cancer, and that
the lack of access to the clinical trial data to a considerable extent is
responsible for this public health disaster (2).
must do - and can easily do, if we get access to the data - better than this
and we should not allow drug companies to bully our societies, patients and
public institutions with their lawyers. The current cases at the European Court
could potentially take years before they are resolved, and we should not accept
that the EMA's new openness policy is put to a halt in the meantime because of
shameful court cases filed by two drug companies who evidently put profits over
a more practical note, we should have received the remaining duloxetine files a
long time ago, but fully understand that the increased workload that the EMA's
new openness policy has created for the agency has caused delays. It seems that
Eli Lilly has not protested earlier when the EMA informed the company that it
intended to send the reports on duloxetine to us, most of which we have already
received. It is therefore highly unlikely that Eli Lilly would now drag the EMA
to court, just because the EMA decides to send us the remaining few files on
duloxetine. And even if it did, the EMA should be prepared to defend the
patients' rights to trustworthy information about drugs.
it comes from the mob or from the drug industry, organised crime is very
serious and it must be fought with all posssible means. If we give in to it, we
also accept its hugely damaging influence on our societies, including the many
deaths it causes.
EMA's letter of 17 June 2013 to us refers to an EMA press release from 30 April
2013, which states that:
the outcome of the final judgement on the main cases, the EMA will continue
with its policy to grant access to documents."
therefore suggest you do exactly this and send us the few remaining files. I
also suggest that the EMA continues to send files and information other parties
ask for, like the EMA has done on an ongoing basis since 2010. We should not be
afraid when people who engage in organised crime send their lawyers. We must
all stand firmly behind the good cause we are defending.
Professor, Director, MD, DrMedSci, MSc
Gøtzsche PC, Jørgensen AW. Opening up data at the European Medicines Agency.
Gøtzsche PC. Deadly medicines and organised crime: How big pharma has corrupted
health care. London: Radcliffe Publications 2013 (in press).