[TerryH]

European Patient Organizations

by TerryH on Thu Sep 22, 2011 10:52 am

I came across the press release below this morning.

Can someone explain to me why European patient organizations would be *complaining* about off-label use of drugs?

I know based on this press release and things I've read elsewhere that there have been safety issues related to the off-label use of Avastin.

Okay, so people need to be more careful about using drugs off-label. That's a good thing to bring to people's attention.

But does it mean that we have to start recommending complicated new rules that are going to make off-label access to drugs even harder than it already is in Europe?

As a myeloma patient, you should care about this. Some of the most effective treatments for myeloma right now are ones that are not strictly "on-label." These "patient" organizations are making it more likely that European myeloma patients won't get access to those kinds of treatments.

Why are these patient organizations urging stricter control of off-label drug use?

Well, just go to the list of sponsors of the "European Alliance for Access to Safe Medicines", which issued the press release:

http://www.eaasm.eu/About_the_EAASM/Members_and_funders

You can bet that these sponsors make expensive drugs that are threatened by off-label use.

It reminds me of the times when I've seen International Myeloma Foundation or MMRF press releases which basically seemed like advertisements for their major sponsors.

I don't know if there is anything we can do about this kind of stuff. I just don't like it when I see it, and I think we should call people on the carpet, as they say, when we see things like this happening.

Cheers!

Terry


European patient groups call for Code of Practice following FDA alert

London, 20 September 2011: Four European patient organisations today published a consensus statement raising concerns about the unlicensed and off-label use of medicines, and calling for a professional Code of Practice.

The consensus statement follows recent warnings by the US Food and Drug Administration (FDA) about a cluster of serious eye infections in Florida associated with the off-label use of an unlicensed medicine.1 Although the exact cause is currently under investigation, the common link for the infections is the repackaging of an unlicensed medicine for use in eye clinics.

Whilst all the patients involved had visual defects before their injections with this unlicensed medicine, some patients lost all remaining vision in that eye due to endophthalmitis (an inflammatory condition in the eye usually caused by infection). There have since been other cases reported by the media in other parts of the United States. The New York Times reported five patients blinded through off-label eye injections in Los Angeles, and also reports another earlier situation in Tennessee which is subject to legal action. 2,3

There have also been reported cases of adverse events in Europe caused by similar off-label use of the same medicine. In Germany, five cases of serious eye inflammation has resulted in legal action by the patients involved, and in Austria, eight cases of eye inflammation have been reported.4,5

The patient organisations’ concern is that the true extent of the problem is not known and there are likely to be unreported occurrences across Europe due to there being no formal and obligatory mechanisms (unlike the case where a medicine is prescribed within its licensed clinical indication) for reporting adverse events involving unlicensed and off-label medicines.

“Our message is enough is enough,” said Jim Thomson, Chair of the European Alliance for Access to Safe Medicines (EAASM). “The FDA was able to act because it was made aware of the problem. In Europe it’s a matter of chance as to whether the regulatory authorities are made aware of similar problems because there is no mandatory mechanism to report adverse events in medicines used this way.

“We strongly believe unlicensed and off-label medicines should only be used when a licensed product is unavailable. In addition, patients should be informed and provide written consent for the medicine to be used and there should be a mandatory adverse event reporting system in place, just like there is for medicines when used for their approved licensed indications.”

The patient organisations involved have put their name to the consensus statement and will be urgently seeking meetings with European regulatory and professional bodies over the coming weeks.