This page is from a
collection of materials indexed at this website
arising from an investigation and campaign by
Brian Deer in The Sunday Times of London
over serious risks and side-effects from this
antibiotic, marketed under many names, including Bactrim,
Septra, Septrin, Sulfatrim, SMZ/TMP and co-trimoxazole.
Go to side-effects homepage
Bactrim
-Septrin -Septra: chronology of a campaign
After
what amounted to a 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, SMZ-TMP, including Forte
and DS formulations). 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 reported 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otherwise being withdrawn as offering the public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. 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 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. 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
four months after the demise of Wellcome plc, in July
1995, 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, as emails to this site, beginning in 2002, reveal.
Brian Deer,
November 2003
Copyright,
Brian Deer. All rights reserved. No portion of this
article on Septrin, Bactrim, Septra, Sulfatrim,
SMZ-TMP, Cotrim, co-trimoxazole may be copied,
retransmitted, reposted, duplicated or otherwise used
without the express written approval of the author.
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