Open Medicine EU

In an unusual move the European Medicines Agency has criticised the Roche pharmaceutical company for not analysing and reporting on over 100 000 suspected adverse drug reactions in the US and elsewhere.

About 80 000 reports from a company sponsored “patient support programme” were not evaluated. These included 15,161 reports of deaths, but it is not known if these had any causal links to the medicines concerned.

The agency also cited “deficiencies” in the evaluation and reporting of suspected adverse reactions from the company’s reporting systems (around 23,000) and clinical trials (around 600).

The company acknowledged that it did not fully comply with regulations. It is addressing the issue “expeditiously” and hopes to have final numbers by January….

According to the EMA, “there is at present no evidence of a negative impact for patients and while the investigations are being conducted, there is no need for patients or healthcare professionals to take any action”.

We are not talking here about 100 000 adverse reactions as such but about 100 000 suspected adverse reactions; the company will now evaluate them to decide which are “genuine” adverse reactions and which are not. This is the standard pharmacovigilence process, although health professionals also file reports. Patients may now do so too but it is not always easy. (There is now an EU database on adverse reactions.

Companies often encourage patients, patient groups and health professionals to report suspected side effects directly to them. This does not exclude, but may reduce, reporting to regulators. Much will then depend on how well the company will analyse and evaluate reports of problems with its own medicines…

In this case the alleged deficiency in reporting 600 adverse drug reactions in clinical trials is of particular concern – food for thought in the proposed revision of the Clinical Trial Directives, and yet another argument for open access to clinical trial data.

In preparing this post I checked the Roche global website to see what they might be saying. I found nothing on this case, only good news about the company. (Click on the “search” button.)

The website does however include the following reassurance: “Roche employs a vast number of people in drug safety whose job is to protect patients from adverse drug reactions. They do this by identifying reactions to Roche drugs as early as possible and classifying them in terms of their severity. Roche’s drug safety departments systematically monitor all Roche drugs worldwide — both before and after they are launched. Whenever a new adverse event is identified in connection with a Roche drug, we work with the health authorities to update the product labelling appropriately”.

Author :