First published in Yoga & Health November 1996

This summer I presented details at a gathering of international scientists, outlining some major changes which appear to be taking place in orthodox medicine. One of those changes concerned a more critical approach to some conventional medical treatments, which so far have been used extensively and were considered to be 'safe'.

One such treatment approach relates to antibiotic use in general. This has come under severe scrutiny in recent years, not only from practitioners in the complementary sector, but at various levels also within the orthodox estab­lishment and in the public domain. At the official level, a 1993 WHO (World Health Organization) report stressed that antibiotics were used too frequently and often inappropriately for coughs, colds, sore throats and respiratory tract infections, especially in children and frequently because of parental pressure.

Secondary infections were uncommon, antibiotics for viral infections useless and could be harmful (1). As long ago as April 1991 Professor Richard Lacey, Consultant Microbiologist, Leeds University, stressed there was growing evidence of bacterial resistance to antibiotics in a World in Action programme SUPERBUG. He then referred to Septrin, one of many brand names of the frequently prescribed broad-spectrum antibiotic known generically as Co- Trimoxazole, as a 'highly dangerous drug'. which in his view should never have been released for general use.

Co- Trimoxazole usually consists of five parts Sulphamethoxazole (a sulphonamide) and one part Trimethoprim (a powerful antibacterial agent). It is also available under many other brand names, notably as Bactrim in the USE and elsewhere, and has been prescribed world-wide since 1969 for many infections, from acne to pneumocystis pneumonia in AIDS patients, but particularly for cystitis and urinary tract infections. Professor Lacey attributed its toxicity to the sulphonamide component.

Three major articles by Brian Deer published in The Sunday Times on the pharmaceutical company Wellcome(2, 3, 4) brought problems with Septrin into the public domain. A flood of letters from injured people followed, and a signi­ficant number were suffering from a 'seemingly disabling and unrecognized syndrome' (i.e.. M.E.).

This came as no surprise to me. I had identified this particular antibiotic as possibly playing a significant role in the onset and/or development of M.E. (Myalgic Encephalomyelitis) in some sufferers, based on questionnaires, which formed the basis of a large multifactorial MSc study into this disorder (5).

Not only had about one in every three females been prescribed this drug on one or more occasions for a variety of health problems (e.g. acne, sinusitis, tonsillitis, and especially cystitis and urinary tract infections) before developing ME or CFS (Chronic Fatigue Syndrome), as some doctors prefer to refer to this illness, but what worried me were an inordinate number of reported severe reactions to it. Antibiotic use was one of several link factors I looked at in my study, but I soon realized it was likely to be an important one. Other factors related to infections, vaccinations, oral contraceptives, stress and diet.

Some unexpected links emerged as well, such as exposure to toxic chemicals, pesticides and powerful electro­magnetic fields. I was not alone in observing the frequent use of anti­biotics prior to development of ME, CFS or CFIDS (Chronic Fatigue Immune Dysfunction Syndrome), the preferred American description. Carol Jessop found that 82% over 1300 CFIDS patients were positive for candida (a Superinfection which can occur after antibiotic treatment) and devoid of normal flora after purged stool specimens, and 84% had recurrent and prolonged antibiotic treatment (6). Many others have made similar observations.

Following the publication of Brian Deer's articles, Professor Lacey, a long­standing opponent of Septrin, addressed two meetings of' Septrin­Sufferers. The first was arranged by Zofia Mescall at High Wycombe in August, 1994 and led to the formation of the Victims of Septrin group; the second was arranged by Nina Hogan in September, 1994 and led to the formation of the Septrin Action Group. The aims of both groups were a complete ban or severe restriction of this drug and the Septrin Action Group also consulted solicitors with a view to taking legal action against the manufacturers.

I related these developments, the potential hazards of Co-Trimoxazole (Septrin) and Professor Lacey's 'Case against Septrin' to readers of InterAction, the journal of the ME patient organization Action for M.E. (7). Of particular significance appeared to be the drug's powerful inhibition of folic acid, a chemical which is essential for bacterial growth. Thus it effectively controls infections. However, folic acid is also essential for the activities of several enzymes and the manufacture of nucleic acids, the genetic material of cells, and hence for the processes of growth and reproduction. It is also vital for the formation of red blood cells by the bone marrow and the proper function of the central nervous system (CNS).

Deficiency can lead to abnormally low numbers of red blood cells (anaemia). The resulting main symptoms include fatigue, loss of appetite, nausea, diarrhoea and hair loss (8).

Professor Lacey in his enlightening talks also stressed the effects this drug can have on the skin, leading in severe cases to Stevens-Johnsons Syndrome, a potentially life-threatening reaction, and long-term problems in the form of blood dyscrasias (diseased constitution), as well as the common destruction of white cells, which fight infections, thereby rendering people more vulnerable to infections. Since many of these problems are part of the ME complex of symptoms, the significance of Septrin in the development and/or onset of ME began to dawn on me.

During the latter half of 1994 and early 1995 the issue of safety of Septrin received much media publicity, both at a local and national level. The most forceful probably was a BBC2 Newsnight item shown on 5.1.1995, in which the ex Chairman of the CSM (Committee on Safety of Medicines) stated he felt future use of Co­Trimoxazole should now be limited by law, and the ex Director of the ABPI (Association of British Pharmaceutical Industries) declared that with the knowledge of hindsight, this drug would probably not have received a product licence in 1994.

It was also announced that Wellcome made a profit of £47 Million in 1993 from the sale of Septrin alone.

In early March, 1995 the Victims of Septrin Group, presented the Chairman of the CSM and the Attorney General with a petition of 1000 signatures, calling for a ban of all brands of Co- Trimoxazole and Trimethoprim, 200 case histories selected from over 1000, and dozens of personal accounts of injuries sustained from these drugs. They also copied in the BMA (British Medical Association), all Health Authorities in England, Scotland and Wales, several MPs and the media. The issue was debated in the House of Commons on 22.3.1995. The drug was placed under full review from 1.5.1995 and on 6.7.1995 Junior Health Minister Tom Sackville announced that its future use would be severely restricted in the UK (9).

By July 1995, 28 ME sufferers had written to Action for ME in response to my article 'Septrin - The Aftermath' (7), reporting very severe reactions to these drugs, some horrific experiences and how they linked development or onset of their ME to their use.

Even more people contacted the Victims of Septrin and/or the Septrin Action Groups. Details of the 28 direct responses were given to the Chairman of the CSM and other drug regulatory authorities.

Additional questionnaire data on 25 of these subjects enabled me to submit an, ­abstract entitled Co-Trimoxazole/Trimethoprim ME Cases to the First World Congress on CFS and Related Disorders scheduled for November, 1995 in Brussels, Belgium. This was accepted for poster presentation and full details were shown at this event (10).

The adverse reactions reported by these ME subjects were even more severe than those reported by subjects of my earlier MSc study group. Again, cystitis and urinary tract infections were most prominent, and adverse reactions included severe skin rashes, immediate collapse and anaphylaxis, as well as muscle/joint pains and hair loss. Apart from having to cope with a crippling new illness, the main problems these subjects often had was to convince their GPs of the nature and significance of these adverse reactions.

However, as details of my latest study indicated, not only did Septrin cause severe reactions, and apparent subsequent ill health in susceptible individuals, but so could, less frequently, the single agent Trimethoprim, which was believed to be a safe drug. The December, 1995 Drugs and Therapeutics Bulletin, an independent review for doctors and pharmacists from the Consumers' Association, contained a review of the Co- Trimoxazole restriction and guide­lines for future use (11). They refer to earlier publications, urging doctors to use a single antibiotic in preference to the Co- Trimoxazole combination. By mid 1995, the CSM had received reports of 127 deaths associated with Co-Trimoxazole and 15 deaths linked to Trimethoprim, but true comparisons of the exact incidence of toxicity could not be made for a number of given reasons. They concluded: 'The change in the licensed indications for Co- Trimoxazole means that, in practice, there will be few occasion, apart from pneumocystis pneumonia (in AIDS) in which this drug should be prescribed in preference to a single antibiotic'.

A literature search revealed that not only were very severe reactions to Septrin documented in major medical journals and publications, but so were severe reactions to Trimethoprim given on its own, particularly if patients had an earlier adverse reaction to Co­ Trimoxazole. A restriction along UK lines was imposed in Sweden in the mid 1980s. A summary of the Septrin developments and possible dangers of Trimethoprim were published in 'What Doctors Don't Tell You' (12).

Since the autumn of 1995, more ME sufferers have sent details of their experiences with Septrin, Bactrim and/or Trimethoprim and subsequent ME, some responses coming from America, Canada and elsewhere. How many ME sufferers were prescribed these drugs is uncertain and exactly how, or indeed if, their use may have contributed to the development of their subsequent illness remains to be established. One thing is certain though: Many problems seen in ME are also documented as possible side effects following the use of Co­Trimoxazole.

This may be just a coincidence, but with growing evidence of the involvement of toxic substances like organophosphate pesticides in the development of this disorder (13), it seems feasible that this now restricted antibiotic could also have played a crucial role.

Only time will tell.

Meanwhile concerns over antibiotics were expressed in Geoffrey Cannon's book SUPERBUG - Nature's Revenge (14). These details were also discussed in a BBC1 Panorama programme with the same title, shown on 15.1.1996.

Of particular concern now are MRSA (Methicillin Resistant Staphylococcus Aureus), a bacterium which is resistant to most antibiotics, except Vancomycin, and VRE (Vancomycin-Resistant Enterococcus), which is resistant to all antibiotics. A further WHO report expressed similar concerns, particularly on TB.

So are we looking at a Doomsday scenario? And if this is so, why were the dangers of antibiotic use, so well documented in the pharmacological literature (15, 16, 17, 18) adamantly ignored by medical practitioners?

It seems it is time for a thorough reassessment of the most appropriate and effective use of these powerful magic bullets, which have saved so many lives in the past, and could still do so if used carefully and sensibly.

Invest in ME are grateful for permission from the editor of YOGA & HEALTH for permission to reproduce the above article.