(Clinical) Trials and errors

The new anticoagulants are a cause for concern. The brilliant medical marketing has meant that so many of our patients are on them.
Perhaps as the years go by, we will get a better understanding of the adverse effects and interactions which are ever so slowly coming to light.

When you consider the number of legal actions against the manufacturers of these drugs, I’m surprised at how commonly they are being prescribed.

Patients are now asking questions.

We are the medication experts, so how are you reassure your patients after they read some ”google” news?

I find it quite difficult when a patient who takes a number of supplements quite satisfactorily for years, is told to stop everything because “we don’t know if those supplements  can be taken with…….”. Many patients just steam ahead, confident that they will be OK. That’s a bit “hit and miss” in my view.

Experts across the world are now calling for the results of all clinical trials to be published.

Consumers aren’t told that companies are allowed to run many trials, and allowed to publish the ones they like, and not the ones they don’t see as favourable.

Independent valuations were important in raising concerns about the heart-attack risks associated with Vioxx, and we don’t want to see another episode like that.

At best, this bias in published results has produced a polluted evidence base.

In fact, I can see the day where in Phase-III trials, patient volunteers won’t be getting involved – the unknown risks are too great when the unpublished stuff is analysed.

Legislators in America and Europe want the problem of missing trials fixed. New legislation is on the way there, but I wonder how strictly that legislation will be enforced.

Regulators can order companies to release their results within an appropriate time frame. Drug firms can only keep investors happy if data is disclosed more freely.

Academics who routinely fail to publish results ought to be followed up by the companies who pay them for that research.

The great unknown here though, is that the problem remains as to what to do about the evidence base for drugs already in use.

The novel anticoagulants might have just squeezed though in time.


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