Side effects risks
Septrin Cotrimoxazole Bactrim Septra TMP-SMZ Sulfatrim

The chronology of a campaign over Bactrim-Septra-Septrin-Sulfatrim

brian

Award-winning investigative reporter Brian Deer (left) recalls his
campaign in the 1990s over side effects caused by the drug often

marketed as Bactrim, Septra, Sulfatrim and co-trimoxazole


Septrin Bactrim Septra Cotrim Sulfatrim TMP/SMX cotrimoxazole TMP-SMZ side effects

This page is from a campaign by Brian Deer in The Sunday Times of London over risks and side-effects from this antibiotic, marketed under many names, such as Bactrim, Bactrim DS, Septra, Septra DS, Septrin, Sulfatrim, SMZ/TMP, Septran and co-trimoxazole | Introduction | Symptom searcher | Tell Brian & help others

The controversial drug containing sulfamethoxazole and trimethoprim continues to be prescribed throughout the world. A plethora of generic and brand names are deployed, especially Septrin, Bactrim, Septra, Sulfatrim, Septran, Cotrim, TMP-SMX, SMZ-TMP, Trimeth-Sulfa, Sulfa-Trimeth, co-trimoxazole, cotrimoxazole - often designated Forte or DS.

Brian Deer's 1990 campaign over side effects

After what amounted to a journalistic fishing expedition in 1993 into the activities of the curious organisation founded by Sir Henry Wellcome, which was part-medical charity and part-pharmaceutical group, several stories ran in The Sunday Times of London in February and March 1994, including a page 1 story about deaths and serious side-effects caused by the synthetic antibiotic (or antibacterial) Bactrim - Septrin (also marketed under scores of names worldwide, such as Septra, Septran, co-trimoxazole, cotrimoxaxole, Sulfatrim, Cotrim, and SMZ-TMP). A news-feature followed, recounting the horrific story of one victim and her family - where the death certificate named the drug.

The core of the allegation against Wellcome, and against the Swiss pharmaceutical giant Hoffman-La Roche, was that a marketing deal in the 1960s to push two synthetic antibiotics led to trimethoprim(from Wellcome) and sulfamethoxazole, (or sulphamethoxazole) (marketed by Roche as Gantanol) to be combined in a single, large pill, in proportions roughly corresponding with the relative sizes of the two manufacturers. It was revealed that the combination conferred no therapeutic benefit in the overwhelming instances where it was used, but inflicted unwarranted risks of side-effects on patients. The combination nevertheless made Bactrim - Septrin vastly profitable by:

* extending patent life on both compounds;

* fostering the marketable (but unwarranted) concept of synergy, which appealed to doctors who might otherwise prescribe single-substance products from rival companies;

* keeping the obsolete sulfonamide, sulphonamide, class of drugs in widespread use when they were otherwise being withdrawn as offering the public a poor risk-benefit profile.

These claims were strenuously denied, particularly by Wellcome plc, trading, confusingly, as The Wellcome Foundation.

In the run of Sunday Times stories, a chart was published, suggesting that a conflict of interest existed in the structure of the Wellcome organisation worldwide, created under the will of Henry Wellcome, through which potentially independent authorities, including academics and members of regulatory bodies such as the UK Committee on Safety of Medicines, might believe that financial advantage to Wellcome would trickle into their own funding or research areas in the form of grant support. This suggestion, implying that Bactrim - Septrin may have flourished as a result of negligence or even collusion by doctors, scientists and regulators - was strenuously denied.

Following the initial stories, and more in 1995, a huge volume of complaints were received from readers saying that they, or a relative, had suffered serious side-effects after taking Bactrim - Septrin. Wellcome, meanwhile, rattled sabres of possible litigation against the paper. Many doctors accused The Sunday Times of being unnecessarily alarmist.

Faced with isolated apparent victims, saying much the same kinds of things, Brian Deer prepared a numbered and standardised form for taking medical histories. The structure of the form was based on the first complaints, and gives a glimpse of the issues that were then coming to the fore.

On April 7 1994 Deer issued a letter and coupon to the first 70 who approached him, to establish whether they would like to make contact with each other: both for personal support and to pursue any campaigning they may feel to be appropriate, at arms' length from the newspaper or Deer. As a result, three groups were formed, all of which attracted further publicity and found many new cases of hidden suffering.

Zofia Mescall, case 3 on Deer's list, and Judith Mullan, the mother of case 2, started Victims of Septrin, which held its first meeting at Sands village hall in Buckinghamshire on August 6 1994. The main orientation of this group was to campaign for restrictions on Bactrim - Septrin.

Nina Hogan, case 25, and Trina Becket, case 4, started the Septrin Action Group, which held its first meeting at the Ibis Hotel, Birmingham, on September 17 1994. This group was primarily focused on claims for compensation, and much of its activity was financed by lawyers seeking clients.

A third group formed around Kate Reid, case 8 (now deceased), which did not hold formal meetings.

Following Deer's criticism of the arrangements under which a grant-giving medical charity controlled a drug company whose products were used, evaluated and supervised by potential - and sometimes actual - recipients of the charity's money, on March 16 1995 the trustees of the Wellcome Trust divested the charity of its interest in Wellcome plc to Glaxo, receiving the biggest single cheque in the history of banking: £2,474,655,000. The merger created GlaxoWellcome plc and, after another merger, GlaxoSmithKline plc.

As a result of the various groups' campaigning, a half-hour debate took place in Britain's House of Commons on March 22 1995, initiated by Kate Reid's member of parliament, Margaret Hodge. A junior health minister denied any cause for concern.

The combination product continued to be marketed throughout the world under dozens of brand and generic names, but in July 1995, four months after the demise of Wellcome plc, the UK Committee on Safety of Medicines, with the Medicines Control Agency, issued a change to the indications of Bactrim - Septrin, which were published to British doctors in an amended data sheet and other documentation, implicitly admitting the campaign's key allegation.

Nevertheless, the toll of deaths, injuries and other side-effects from products containing sulfamethoxazole and trimethoprim continues throughout much of the rest of the world, as emails to this site, beginning in 2002, reveal.

Updated September 2011


Copyright, Brian Deer. All rights reserved. No portion of this article on Bactrim, Septra, Septrin, Co-trimoxazole, Sulfatrim, TMP-SMZ etc may be copied, retransmitted, reposted, duplicated or otherwise used without the express written approval of the author. Your feedback is appreciated - via the briandeer.com contact page