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Wednesday 26 June 2013

The EMA should continue its new openness policy despite current lawsuits

Peter C Gøtzsche, Professor    



Nordic Cochrane Centre, Rigshospitalet, Copenhagen

21 June 2013
The EMA should continue its new openness policy despite current lawsuits

Open letter
To Guido Rasi, Executive Director of the EMA

Dear Guido Rasi,

The 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.

We 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:

"The 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 following documents..."

We 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.

When 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.

We 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).

We 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 patients.

On 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.

Whether 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.

The EMA's letter of 17 June 2013 to us refers to an EMA press release from 30 April 2013, which states that:

"Pending the outcome of the final judgement on the main cases, the EMA will continue with its policy to grant access to documents."

I 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.

yours sincerely

Peter C Gøtzsche
Professor, Director, MD, DrMedSci, MSc

1 Gøtzsche PC, Jørgensen AW. Opening up data at the European Medicines Agency. BMJ 2011;342:d2686.

2 Gøtzsche PC. Deadly medicines and organised crime: How big pharma has corrupted health care. London: Radcliffe Publications 2013 (in press).

Competing interests: None declared

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