On Saturday 29th September 2009 an article appeared in the Guardian one of the UK’s wider read broadsheets entitled ‘Soaring Drugs Bill Threatens to Bankrupt NHS’. The article refers to a report published on the same day by left leaning think-tank Compass, an organization that describes itself as ‘Direction for the Democratic Left’. It reports amongst other things that innovation within the pharmaceuticals industry is in decline, with the majority of new medicines in the market place neither improving on older versions nor offering new lines of treatment and aimed solely at gaining market share for their producers. The authors argue that this model does not represent a sustainable way to proceed.

One of the co-authors of the report Zoe Gannon argues that the industry is in need of regulation due to its social importance, and the other co-author Jon Cruddas MP believes that government intervention is necessary to ‘stop biased clinical trials and excessive influence over the medical profession’.

Finding this argument interesting and extremely relevant for the foundation I contacted Compass who kindly sent me a press copy of the report and the following is an outline of the findings. As this was a press copy I cannot put a link through to it, but a PDF version is available from the Compass website at a cost of £5.00 but I will try to cover all the points raised in this article.

The report is in fact entitled ‘A Bitter Pill To Swallow, Drugs for people, not just for profit’, and the executive summary begins by comparing the present state of the pharmaceutical industries (the third largest industry in Britain) to the state of the financial industry (the second largest) before the crash, stating that lack of regulation and drop in productivity but a rise in profits and executive pay are already visible warning signs of a looming social and economic disaster. Although the cost for the NHS of buying medicines has rocketed by more than £7.5 billion over the last 15 years drugs companies are producing fewer new drugs that improve upon those already existing with more than half of all new medicines offering no improvement over the older versions. The number of new molecular entities introduced each year has halved since the 1960’s and this lack of innovation leads to non-sustainability within the industry . The report continues by stating that this industry cannot be allowed to fail as this would have a direct effect upon the welfare and health of the population, and therefore these things cannot just be of interest to the various boards of directors but must be of interest to society at large.

The summary continues by describing how drug companies fund and regulate their own trails and also spend huge amounts of money on trying to influence choices made by medical practitioners, in fact these companies spend 300 times as much money as the UK government on post graduate doctor training aimed according to the authors at guiding their prescription choices.

The report makes 5 priority policy proposals:
Make a greater investment in publicly funded science with £1 billion of extra funding between 2010 and 2011
Make clinical trials open to public scrutiny
Educate doctors through public funding
Review progress made since the 2005 Health Select Committee Report
Control pay and bonuses

After the introduction that gives a background to current situation including government policies in the post war NHS years the report is presented in 7 large sections, the first entitled ‘The Problem, The cost of drugs and declining innovation’.

This section begins by offering some data regarding the cost of medicine to the NHS. As noted above the medicine bill is exploding, shooting from £2.5 billion in 1991 to almost £11 billion today. These rises are accompanied by a rise in profits for the drug companies, but these very companies seem to have changed their approach to the market. Each year the number of drugs offering marked therapeutic advantages declines, and although new drugs are placed in the market they are more and more new versions of older drugs with no therapeutic innovation. One of the causes is given as the way that trials are adjudicated. As the drugs are tested and the results are processed, a decision is made as to whether to continue the trail. This decision is not however solely based upon the efficiency of the drug in question but on its profitability. The result is that the re-marketing of older medicines is seen as a better financial option, little difference in efficiency but an already tried and tested waiting market.

The companies are also searching for what the report calls ‘blockbuster drugs’, medicines that are for long term use and can gross large profits for their manufacturer, and this obsession conditions the types of research carried out. The authors claim that this is not a sustainable model and that investment in research and design (R&D)must increase.

Investment in R&D is not however only carried out by drugs companies, and although public investments amounts to less in terms of money more than 70% of new molecular organisms that have entered the market over the last decade are the results of publicly funded science.

The report offers some suggestions already mooted by the UK government including a pricing scheme that reflects the therapeutic value of the medicine to its end user and a scheme in which the companies agree to lower the prices of less effective drugs in the short term, but allowing for a possible price rise if they can demonstrate that the product was more efficient than at first thought.

The second section is entitled ‘Bias in Industry Sponsored Clinical Trials’ and the content is easy to imagine. The industry conducts its own drugs trials and the authors claim that it is easy to hide unwanted data. Unfavourable trial results are under-published or delayed and favourable results are over-published. The design of the trial can also contain bias. If the trial does not look for side effects then no side effects will be found. One study reported that independent research is 8 times less likely to reach favourable qualitative conclusions than industry sponsored research. Obviously there are enormous ethical implications here but also enormous economic implications for the companies.

The report recommends the mandatory disclosure of research results, the setting up of a national standards committee and the setting up of independent research trials to counter the above problems and allow greater transparency.

The third section is entitled ‘The medical professional and the pharmaceutical industry’.
The influence that pharmaceutical companies can exert upon medical practitioners seem to be much greater in America with many doctors conducting what they describe as a relationship with drug companies and their representatives. The equivalent of almost half of the R&D budget is spent on relationships with doctors with the aim of changing their prescribing practices. This includes lectures and postgraduate education, and some studies show that doctors that attend lectures in which certain drugs are highlighted tend to prescribe that drug more. Also in the UK more than 30% of post grad training is funded by drugs companies and so could potentially be biased towards those companys’ products.

Possible solutions include the ‘no free lunch’ pledge by which doctors do not accept gifts and promotions from drug companies, the on-line publishing of gifts received by doctors, the funding of medical training by the taxpayer instead of by drugs companies and training for trainee doctors on how to deal with drug reps.

The section entitled ‘The pharmaceutical industry and the public’ goes on to show that the industry’s influence within the public sphere does not just end with doctors. Burgeoning advertising budgets prevail not only here in the UK but throughout the world. The problem that the authors feel should be highlighted in the UK is the industry’s growing involvement in the funding of patients’ groups. It would appear from the report that the majority of these groups in the UK take money from drugs companies, and this has obvious implications for their status as independent when offering advice to patients. The report recommends that all sponsorship should be made transparent, additional funding should come from the government with the aim of lowering the drug company’s influence in this sphere and that funding should go into a blind pool so that it can be distributed independently of industry influence.

The next section entitled ‘The human consequences of market failure in the pharmaceutical industry’ offers 4 case studies in which bias in science and ineffective regulation have had human consequences.

The first is the story of the development and use of SSRI drugs such as Prozac. Prozac for example provides its manufacturers Eli Lilly with more than 25% of its $10 billion a year revenue. These types of drugs have been criticised for their effectiveness (studies have found that in most cases a placebo has the same effect) and damaging side effects (including suicides) but they are still prescribed to millions of people across the globe and seen as wonder drugs.

The description of the clinical trials for Voixx that follow would make your toes curl. 6 years after its introduction as a safe alternative to non-steroidal ant inflammatories the drug was removed from the market because it significantly increased the risk of cardiovascular incidents. It appears that there had been suggestions that this might have been the case before the trials were started and that they were designed to not reveal this possible problem. It is estimated that between 88 and 130 000 American had heart attacks in the 5 years that this drug was on the market as a result of its consumption.

A further example is of Baycol (only 52 deaths though) manufactured by Bayer as an anti cholesterol drug and prescribed to millions of people. Legal claims over the health implications of taking this drug have resulted in Bayer having to pay out (so far) $872 million in compensation, something that the report argues could have been avoided through better trials procedures.

Retalin and Concerta are amphetamines for children. In the UK about 1% of children take these drugs (at a cost of £28 million for the NHS) as treatment for Attention Deficit Hyperactivity Disorder, but in the US it is estimated that 10% of all children take it. The original study into the efficiency of these drugs found that after 1 year’s use the effects were better than behavioural therapy, but one of the co-authors stated in 2007 that benefits were being exaggerated and that in the long run there were ‘no beneficial effects’. It is also becoming clear that there are side effects in growth patterns associated with their use. Other alternative treatments that have been found effective are diet and exercise but they are apparently not favoured over the chemical approach.

And on to the interestingly titled ‘Why is the pharmaceutical industry getting away with it?’ section. The authors open this section by laying the blame at the feet of neo-liberalist economics, the idea that the market regulates itself through profit making and so regulating reforms are not seen as a priority.

The authors also criticise the funding system of The Medicines and Healthcare Products Regulatory Agency (MHRA) that is funded through licensing fees for the pharmaceutics industry. In giving licenses however the agency is in competition with The European Medicines Agency so in some way has to attract license applications. This obviously has implications for the agency’s independent status and one visible effect of the pressure that the industry can lay to bear on the agency could be the shortening of the time needed to grant a license.

Other problems cited are that the MHRA does not put pressure on companies to demonstrate that their new drug is therapeutically more effective than existing drugs and is also under funded and so cannot effectively regulate already licensed medicines.

The Pharmaceutical Price Regulation Scheme also comes under fire as a recent Office Of Fair Trading report argued that there is a serious question as to whether value for money is being secured. The authors propose the replacement of the scheme with a value-based system that could incentivise innovation and save money.

The report praises the work of the National Institute for Clinical Excellence but also makes several recommendations including that the institute should receive more funding, have access to all licensing data, should assess the data it receives and be more transparent in its decision making process.

The final section entitled ‘policy recommendation’ outlines the report’s recommendations as given at the beginning of this article.

Make a greater investment in public funded science funded through the savings that a value-based pricing scheme would generate.

Make clinical trials open to public scrutiny with all phase 3 trials carried out independently of the industry.

Educate doctors through public funding in order to avoid possible industry bias.

Review progress made since the 2005 Health Select Committee report. This is a long governmental report that addresses many of the issues raised in today’s report and comes to similar conclusions. See the link above for PDF download.

Control pay and bonuses so that pay awards do not disfigure the product market.

And finally to the report’s conclusion.

The conclusion states that the industry is of great socio-economic importance and that it cannot be allowed to fail in the way that the financial services industry has, as this would wreak serious consequences for society as a whole. Innovation must improve but this will only happen when the industry looks less towards profit and more towards therapeutic improvement as its goal. We cannot expect the industry to act as a charity while the health market is determined by profitability and not by need, so this needs to change.

This report is interesting to me as it raises all kinds of questions regarding the institutional role and ethical and social responsibilities of an industry governed by profit making. As noted in previous posts and in the Hastings Centre’s dedicated blog, Medicare and Medicaid are also struggling under the weight of drugs bills and the difference in advertising laws can only make the problem worse (in the USA all types of medicine can be advertised on TV, in the UK only those that do not require a prescription). I imagine that people present themselves at the doctor’s surgery already knowing the trade name of the product they ‘require’. Drugs prices also vary throughout the world and the US is the most expensive market and this certainly will not help the government budget.

On a personal note I see the difference between Italy and the UK. Medicines in Italy cost a lot more than they do in the UK, in many cases 4 times the price, and a trip to the chemist is a dear do here.

The fact that many of the patents for the so-called superdrugs are about to expire means that generic copies of some of the most profitable medicines will come onto the market next year, so large drug companies will lose a lot of their profits exacerbating the current situation. Cost-cutting exercises and mergers may not plug the gap and action needs to be taken that employs long-term thinking and policy-making.

For an light hearted look at the problem watch the video below. Entitled ‘Cradle to the Grave‘ it shows the ammount of prescribed medicine that the average person takes in a year and is part of an instalation at the British Museum.

(photo: Med Alert – by El Freddy from Flickr)