Online debate at - 22 February 2005

See notes below, prepared for the 'DRUGS AND HEALTH' online debate organised by SPIKED. The debate kicks off with a live event, at the Society of Chemical Industry, 14-15 Belgrave Square, London SW1X 8PS, 6.30pm-8.30pm on Tuesday 22 February 2005. Speakers include: Diarmuid Jeffreys  (author, Aspirin: The Story of a Wonder Drug); Charles Medawar  (executive director, Social Audit); and Richard Sullivan  (head of clinical programmes, Cancer Research UK)

"Do we need tougher measures to ensure drugs are safe?
Or does regulation already mean we wait too long for
new and better drugs to reach the market?"

This response to the debate is structured around the four main questions arising, but in a rather back-to-front order: [1] Are new drugs better drugs? [2] Does drug regulation delay therapeutic gain? [3] Can drugs be "safe"? [4] Would "tougher" regulation make drugs safer?

1. Are new drugs better drugs?
The notion that newer drugs are better drugs is an essential feature of the "Conspiracy of Goodwill". It is not only a daft generalisation, but also encapsulates the drug-centred mindset that spoils so much understanding. Even the notion that genuinely "better" drugs have to be new products is suspect. The reality is that, whatever the importance of new products, better use of (and access to) existing drugs, and improved understanding of drug benefits and harms, present the best opportunities for improving treatment and making health gains.

Obviously, we need new drugs and, if we don’t invest in drug innovation, we won’t get the better ones we urgently need. That is not in dispute. The key issue is whether it makes (either health or economic) sense to rely so much on the Pharmas and on market forces to spearhead this vital social endeavour. I cannot accept this, but is very much the prevailing wisdom in market economies, the ‘official’ view. The Department of Health, for example, "believes that the current model – whereby medicines are developed by the private sector in response to what they perceive to be the demand of healthcare systems – is more effective and efficient than alternatives that could be considered …"

The European Commission’s Directorate for ‘Enterprise’ (i.e. trade promotion), which has oversight responsibility for drug regulation throughout the EU, has proved especially uncritical in its conviction that new drugs are better ones. The evidence just isn’t there: a probably generous estimate would be that about one in four drugs offers some real therapeutic gain.


2. Does regulation delay therapeutic gain?
The short answer is no. Average new drug approval times are measured in days (in the range 50 – 100 days). Much more significant factors would be drug performance and the type and scale of drug promotion – and their influence on the rate of ‘take up’ of new drugs by prescribers. The pharmaceutical industry doesn’t complain much about the impact of drug regulation:

"The MCA is one of the best and most efficient regulatory agencies in the world, and it is a real asset to the pharmaceutical industry, the NHS and patients." (ABPI, 16 January, 2003).

The industry has criticised UK doctors for a ‘take up’ rate of new drugs to be compared with Croatia (but without mentioning that it is higher than in Japan). The counter argument is that a cautious approach to new drugs is appropriate and well justified: news of really important advances in drug therapy will always spread fast – very much sooner, alas, than evidence of drug risks and harms.

The real problem is that it often takes years of post-marketing experience to establish the real value and utility of new drugs. Recent experience with Vioxx and similar drugs and with the SSRI antidepressants highlights this. Recently, the Chairman of the UK Medicines and Healthcare products Regulatory Agency (MHRA) was asked what had been learned from the experience with SSRI antidepressants. He said: " …the main lesson which has been learnt … the first lesson, is that the safety profile of a medicine, when it is licensed, is not very well known …" In 1988, a former Chairman of the Committee on Safety of Medicines said much the same: "by the time a new drug is licensed we really know very little in the case of a new chemical entity about its possible risks".

It follows that real risks are involved in permitting the intense promotion of drugs at launch, at precisely the time we know least about their harmful effects. The lack of sophistication in present systems of drug licensing is underlined by the extent to which dosage recommendations are changed (about one in six drugs), or major new warnings added (over half), after drugs have been approved.  

3. Can one ensure that drugs are "safe"? 
Again, the short answer is no – and that this focus is quite wrong. We need to stop thinking about "drug safety", as if ‘safety’ is some property that resides in the drug. The focus should instead be on:

  • the safety of drug users (including both doctors and consumers);
  • the quality of drug regulation and the probity of commercial endeavour;
  • the relationship between the probability of benefit and/or harm – always taking into account the alternatives to drug treatment, including non-intervention;
  • the relationship between the medical, social and personal significance of positive and adverse "drug effects"; and
  • the extent to which studies of drug effects in specific populations can predict outcomes for you and me.

3. Would "tougher" measures help?
"Tougher" would be one of the last words I’d use. If the end point is ‘health’, I’d sooner argue the need for a complete overhaul of present-day drug policies and systems of drug control. I am optimistic enough to believe that my grandchildren, when they are my age, will look back at 2005, and feel rather the same as I do when contemplating the state of drug utilisation in my grandfather’s day.

Today, it seems there is some real confusion between commercial imperatives and health needs – evident enough nationally, but in less developed countries, above all. The remedies, in relation to drug policy and regulation already seem clear enough, and apply globally. The top priorities are:

1. Dedicated concern for health priorities;

2. Commitment to transparency and accountability;

3. Focus on human experience, values and needs.

I recently saw, for the first time, the British Medical Journal obituary of my grandfather. He qualified as a doctor long before there were many useful drugs around, but he got exactly the point that we seem to be missing today. This extract refers to his practice in Cambridge, after the 1914-1918 War: 

"He soon became acknowledged as an authority on the degree of ‘well-ness’ of the individual rather than on the ‘ill-ness’ of a patient. Though he was always experimenting with apparatus for measuring different functions of the body, he never lost sight of the fundamental importance of variations in individuals. In consequence, he never tried to squeeze those he examined into stereotyped moulds, and throughout all his researches and all his investigations he retained his love of the individual and its wonderful variations."

(British Medical Journal, 6 July 1935, ii, 41).


Charles Medawar
31 January 2005