Drug Research Crisis

3 October 2019

Governments say that they want to fund research, but think that they are very clever if they can do it ‘in cooperation with the private sector’.  They think that they will save money and get some inside running to a share of profits.  Mostly they are played for mugs.  The private sector does research that it might not have done if it had to pay the full cost.  They also get to distort the agenda towards what is more profitable rather than what it might be socially useful to know.  And they see what the lab is doing and can do while they lock up the intellectual property rights and the profits.

But this is only a fraction of the problem.  Much research today is unsuccessful- the drug tested does not work or is not better than the one it is tried against.  The research labs are under pressure to prove it ‘works’, so they will get more work.  Also as the trials get more complicated they involve many centres, huge amounts of data, coordination, management and then to be written up, all by specialist people who have big clinical and academic loads and are ‘time poor’.  Enter the funders and ‘ghost writers’, to help.  One wonders how much input the eminent people whose names are on the paper actually wrote.

But another problem is that the FDA (Food and Drug Administration in the US) has to see all data written about a drug.  This is confidential.  The company gets to decide what is released publicly.  The FDA gets to decide if there is any public detriment to having the product on the market. i.e. they do not actually have to decide it works, they only have to decide that it does not have an overall detriment.  So if it is no better than something else, it is still OK to be released and the marketing decides which product is preferred.  Most people think that the FDA has to decide if something works- this is not so.  If there were a number of studies and half of they showed a drug was better, and half of them showed it was not, the drug companies could simply release the ones that showed it worked better, and keep the other half secret.

A Welsh researcher, Dr David Healy, pointed out the FDA situation and drew attention to the case of new psychiatric drugs, where a large percentage of the papers given to the FDA never saw the light of day.  His own career suffered.  He got the offer of a university post in Canada but this offer was withdrawn, allegedly because the Uni was threatened with withdrawal of drug company funding if he was appointed.  There have been suggestions that the drugs increased the suicide rate, so Healy has just said, ‘give us all the data and let us decide’.  Still no deal.

Some years ago, a scientist called Cochrane who got lymphoma was somewhat horrified about the way that his treatment was decided and set up the ‘Cochrane Collaboration’ to look at all published data and work out which treatments are evidence-based.  The concept of ‘evidence-based’ medicine was given a boost.  Many governments have cooperated with Cochrane and it rates treatments more rigorously than anyone else.

But Healy drew attention to the fact that Cochrane has the flaw that they can only work on published data, so since what they evaluate cannot not be trusted, their conclusions are still problematic.

Healy is now drawing attention to some troubles within the Cochrane movement with some high-profile people leaving.  One could ask why his paper is in the ‘Indian Journal of Medical Ethics’. No Anglo journals interested?