Trial behind closed doors?

Posted on by Mark

“An MP’s Committee has warned that drugs companies routinely withhold results of clinical trials from doctors, leaving them poorly informed about how to treat patients”

This report from the Public Accounts Committee arose as a result of the Department of Health having to destroy £74 million of the drug Tamiflu as a result of poor record keeping by the NHS; they originally stock-piled £424 million of the drug.

So what’s the fuss about?

Former students of the Primary Care Training Centre will be well aware of the Phase 1-4 process of testing new drugs before and as they are released onto the market.  All this testing has to be carried out at the expense of the pharmaceutical company producing the new drug.  As a result of this testing, which is published in the form of trials in reputable journals, the powers-that-be decide whether or not a new drug should receive a licence.

It has been known for ages that reputable journals are about twice as likely to publish trials which resulted in positive results rather than those which had negative or neutral results.  By “negative” or “neutral” results we mean that a new drug was either worse than or at least no better than existing therapies.

Now let’s look at a likely scenario.  A company has spent hundreds of millions of pounds developing a new drug.  At Phase 3 trials, they are carrying out a series of trials comparing their new drug with a placebo or comparable existing therapy.  They submit for publishing those trials which show the biggest benefit of their new drug and are therefore the most likely to be published.  Hard-nosed economics or human nature?

Is there an answer?  Probably not, because there is nothing to stop a pharmaceutical company terminating a trial before its conclusion if it is not worth carrying on.

As a matter of fact, the boot can be on the other foot.  GlaxoSmithKline lost hundreds of millions of pounds of income due to the banning of rosiglitazone following an extremely dubious meta-analysis in the USA about the causation or not of cardiovascular disease.  The conclusions of the trial have become more and more doubtful as the years have gone by but it is highly unlikely that the drug will ever get its licence back.

Let’s be honest, pharmaceutical companies are not public charities.  They are answerable only to their shareholders.  As long as they pay the costs and are not dishonest, they can publish whatever they like.

If the NHS want a completely unbiased assessment on the effectiveness or not of Tamiflu, they should pay for the appropriate trial themselves rather than complaining about the availability or not of information.  Richard Bacon is being rather disingenuous when he says “It’s very difficult to tell what is and what is not dangerous when the information is not publicly available.”  No it’s not; go out and get some research done yourself.  That is exactly what the British Hypertension Society did with blood pressure lowering therapies.