I have recently been writing letters to our local newspaper “The Craven Herald” (1) in which I have advocated a fundamental shift in NHS policies. My stance is that pouring more and more money into the system is a dead end approach. In particular, there needs to be a switch in emphasis towards prevention at the expense of the current curative approach. A good start would be to evaluate the expenditure on drugs. Many of those currently in use are totally ineffective and when allowance is made for the impact of adverse side effects, most patients would be better off without them. Statins are a very good example because the benefits are minimal. NICE has accepted that for those who have heart problems, 77 individuals have to be treated for one to benefit (2). Dr Malcolm Kendrick has worked out that this benefit equates to an extra 6 months of life for 1.8%. For the remaining 98.2% there will be no life extension and of course many will have deal with the side effects.

Another example is Type 2 Diabetes (T2D) which currently costs the NHS £10Bn per annum to treat, of which about £1Bn is for drugs. The official position is that if you are diagnosed with T2D you cannot be cured, the disease will get worse and you may expect to be on drugs for the rest of your life. This is absolute rubbish because there is convincing extensive evidence to show that it can be cured by simple changes to diet (3). All that is necessary is to reduce sugar and other sources of carbohydrates, such as potatoes, bread, rice and pasta. These can be replaced by healthy fats such as olive oil, coconut oil and the fats in meat and milk, ideally from animals which have been fed on grass. There are also hundreds, if not thousands, who have successfully cured their own T2D by using this approach and most of these have been able to come off drugs completely. Others have reduced the amount needed. It is therefore absolutely bizarre that the official advice is usually to reduce fat intake and increase the amount of carbohydrates. So it is no great surprise to discover that the rather dire prognosis is fulfilled. If people were given the correct advice the disease could be cured for many of those currently afflicted and the savings would be immense. By contrast, the present trends are expected to continue, which means that the number with T2D will double again within the next 15-20 years.

During 2013, in England alone the total expenditure on medicinal drugs was about £15Bn, although many of these were of very limited value (4).

I was somewhat surprised to be challenged by the candidate for the Green Party in this constituency (Skipton & Ripon) on the grounds that some drugs do work. In particular he claimed that;

“Cancer survival rates are massively improved and much of this is down to expensive new drugs”.

First of all, the conclusion that survival rates have improved is questionable. A recent article in the Lancet states quite bluntly:

“Current strategies to control cancer are demonstrably not working. Already one of the world’s leading causes of death, the annual death toll from cancer has risen by almost 40% since 1990 and this rate of increase is set to continue. WHO predicts deaths from cancer will rise from the current level of around 8 million lives a year to more than 13 million by 2030” (5).

Secondly there is widespread concern in the medical profession about the very high charges for drugs generally. In the USA, the average price of 1 year of treatment with a new cancer drug now exceeds $100,000, and the benefits of many of these therapies — often improvement in median survival of the order of weeks to months — do not appear commensurate with their prices (6). It is very common for new drugs to be introduced which are no more effective than those already available but are much more expensive. There is genuine concern that the drug companies exploit the systems to overcharge by huge amounts.

For example in 2008, the drug cetuximab was hailed as a major breakthrough in cancer treatment but actually when used in conjunction with other drugs to treat lung cancer it was found that the benefit was just an extra 5 weeks of life which was accompanied by some nasty side effects. The cost of treatment of lung cancer with this drug is $80,000 for 18 weeks (7).

Despite the claims by the pharmaceutical companies that they make a huge contribution to society, the reality is that they are developing drugs that are mostly little better than existing products but have the potential to cause widespread adverse reactions even when appropriately prescribed. The fundamental objective of the industry is to maximise profits by developing lots of drugs which have clinically minor additional benefits.

In fact the Food and Drugs Administration (FDA) in the USA can actually approve drugs even if they are inferior to those which are already on the market. An evaluation conducted in France concluded that of all the new drugs approved between 1981 and 2001, about 12% offered therapeutic advantages. However between 2002 and 2011, only 8% were assessed as genuinely better than existing ones. In addition almost 16% were judged to be more harmful than beneficial. As few as 1.6% were considered to be substantially better. Assessments by the Canadian advisory panel to the Patented Medicine Prices Review Board and by a Dutch general practice drug bulletin have come to similar conclusions (8).

Two studies have found that 80% of the increase in drug expenditures was to pay for these minor-variation new drugs, rather than for important advances. Companies claim that R&D costs are “unsustainable.” But the reality is that revenues have increased six times faster than has investment in R&D over the past 15 years. The drug industry has been able to manipulate decisions taken by government for the following reasons:

  • Because politicians are dependent on drug companies for financial support to get elected as public representative, there has been a reluctance on their part to ensure that the regulatory process is completely thorough and effective. This can be demonstrated as follows:
  1. New drugs are often tested against placebos rather than against established effective treatments.
  2. Surrogate or substitute end-points instead of the actual effects on patients’ health are often used to assess the effectiveness of new drugs.
  3. Noninferiority trials which show that the product is not worse than another drug used to treat the same condition by more than a specified margin are accepted. Ideally there should be a requirement to show that the new drug is significantly better than one already on the market. These criteria do not conform to international ethical standards because they provide no useful information for prescribing.
  • Companies are allowed to test their own products. Hence the trials are designed in such ways that they minimise the detection and reporting of harms and maximise evidence of benefits. They are permitted to exclude patients who are most likely to have adverse drug reactions, while including those most likely to experience benefit. Therefore drugs can be marketed as safe and more effective than they are in the real world.

As a consequence it is approving drugs which are little better than those available, is failing to ensure there is sufficient testing to control serious risks in order that the public is protected from harmful side effects. Essentially these failings serve commercial interests well and public health suffers.

Although the industry justifies its high costs on the grounds that the research is expensive, it is revealed that net of government subsidies, only 1.3% of revenues is spent on discovering genuine innovations, which contrasts with the 25% spent on promotion.

In recent years there have been various exposures of how the drug companies operate and it is evident that they are not genuinely interested in improving health. It is somewhat ironic that in the USA drugs are the third leading cause of deaths after heart disease and cancer, which is horrendous. The position in Europe is much the same. Anyone who is interested in understanding what is actually going on should read the excellent exposé by the distinguished Danish scientist, Peter Gøtzsche, entitled:

Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare” (9).

Here are just a few of the points he makes:

  • In 2004-5, the House of Commons Health Committee examined the drug industry in detail and found that its influence was enormous and out of control. It was revealed that the industry buys influence over doctors, charities, patient groups, journalists and politicians, and whose regulation is sometimes weak or ambiguous. It found that the Department of Health (DoH) was responsible for representing the interests of the drug industry. The government did nothing and the DoH even defended the industry. As Gøtzsche commented:
  • With a governmental attitude of total denial it’s no great wonder that crime flourishes in the drug industry and spreads like weeds”.
  • Erlotinib is a drug which is used to treat pancreatic cancer which has been approved in Europe and in the USA, although it only prolongs life by 10 days. It is toxic and has very unpleasant side effects. For one extra year of life (36 patients in all) the cost would be $500,000.
  • Peter Rost is a whistle blower who used to be in a senior position with Pfizer and has described the industry as follows:
  • “It is scary how many similarities there are between this industry and the mob. The mob makes obscene amounts of money, as does this industry. The side effects of organized crime are killings and deaths, and the side effects are the same in this industry. The mob bribes politicians and others, and so does the drug industry …”

The extent of the illegal activities of the pharmaceutical companies is shown by the penalties levied on them by the authorities in the USA (10). Between 1991 and 2010, there were at least 165 settlements for offences which included illegal off-label promotion of pharmaceuticals and deliberatively overcharging. The total amount paid was almost $20Bn of which 75% was in the period 2005-2010. An update has found that in the 21 months ending in July 2012, a further $10Bn was paid (11).

Conclusion

It is clear that this industry is totally out of control. It is making enormous profits and has been extremely effective in using its resources to gain unfair advantage in the market place. It does not hesitate to use unethical, unscrupulous and illegal activities in the course of its business. Given the large number of deaths which can be attributed to drugs, it is doubtful if this industry makes any positive net contribution to improved public health.

 

REFERENCES

  1. http://www.cravenherald.co.uk/
  2. http://linkis.com/drmalcolmkendrick.org/EWaOW
  3. http://www.nutritionjrnl.com/article/S0899-9007(14)00332-3/fulltext
  4. http://vernerwheelock.com/?p=667
  5. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)60059-8/fulltext
  6. http://www.nejm.org/doi/full/10.1056/NEJMp1400104#t=article
  7. T Fojo and J Grady (2009) Journal of National Cancer Institute 101 (15) pp 1044-1048
  8. D W Light, J Lexchin & J J Darrow (2013) Journal of Law, Medicine and Ethics 14 (3) pp 590-610
  9. Peter Gøtzsche(2013). “Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare” Radcliffe Publishing London
  10. http://www.citizen.org/hrg1924
  11. http://www.citizen.org/hrg2073