How Bad is Bad Pharma?

People reflecting on this decade will see clinical trials transparency as transformative movement in the pharmaceutical industry. It has received global attention, generated miles of column inches and at least one best selling book. The book in question, Bad Pharma, by Ben Goldacre is seen by many as having birthed (or at least resurrected) the movement. Their demands are relatively simple, but very controversial; the release of all clinical trial data on drugs currently in use.

The movement has sparked to life a range of the industry’s most influential organisations such as the EMA which is set to release a draft policy in June and has already (as we shall come to later) taken a more open approach to clinical trials data. The UK parliamentary Science and Technology Select Committee is currently hearing evidence on the topic. The National Audit Office is looking into the access to clinical trial information on Tamiflu. The ABPI announced new transparency measures in February and PhRMA released new principles of conduct of clinical trials in April.

There is a lot of change occurring and it is happening quickly but not everyone is happy about it. There are many reasons why this makes some individuals uncomfortable, but the three main reasons that opponents quote are: patient confidentiality, protecting trade secrets and preventing misunderstanding (intentional or otherwise) of clinical trial data.

Two of these factors collided in March of this year when AbbVie launched a suit against the EMA to prevent it from releasing clinical trial data on their rheumatoid arthritis drug Humira. Two other suits have also been filed, one by Intermune and another by AbbVie. AbbVie stated that they took action to protect confidential and commercially-sensitive information. With the current context, these cases were controversial enough on their own; however the General Court of the European Union issued an interim decision which ordered the EMA to desist from releasing information. This decision caused outcry from the proponents of transparency.  All Trials, the organisation set up in January to push for the release of clinical trial data described the injunction as “a huge backwards step”.

However unpopular the injunction is, it does highlight an interesting problem; to what extent are clinical trials commercially-sensitive? Is one company’s trial design proprietary information? And if so how would those companies publish their trials in order to meet regulatory obligations?

The issue is complicated one with many different and sometimes opposing facets and it is set to rumble on. The EMA is to put its new clinical trials policy into action by January of next year, so it seems likely that this topic may loom large on the regulatory landscape for some time yet.

What do you think about this issue and how does it affect you?