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People on
psychiatric drugs should report side effects directly to drug safety
watchdog
January
17, 2005
by Adam James
Patients
- including those on psychiatric drugs - should be encouraged to
report unexpected side effects directly to the drug safety watchdog,
the lobby group for the pharmaceutical industry has recommended.
Patients
have to presently go through their GP or doctor's "Yellow Card"
system to officially report adverse drug reactions (ADRs) to the
drug regulator, the Medicines and Healthcare Products Regulatory
Agency
But the Association of the British Pharmaceutical Industry (ABPI)
has now called for direct patient reporting of ADRs to be more "aggressively
promoted"
The
ABPI has also demanded doctors be assessed to ensure they are properly
using the Yellow Card system.
The
recommendations were part of a written ABPI submission to an inquiry
into the influence of the pharmaceutical industry by the House of
Commons Health Select Committee.
The
safety of SSRI (selective serotonin reuptake inhibitor) anti-depressants
has become one of the central concerns of the inquiry. However,
the Medicines and Healthcare Products Regulatory Agency stated last
month that evidence of a relationship between suicidal behaviour
and increasing/decreasing dose of SSRIs is not robust. The agency
had assessed Yellow Card data in helping it to arrive at this decision.
Nevertheless,
thousands of patients complain of disabling side-effects when both
starting - and withdrawing from - SSRIs.
In
addition , Stuart Dollow, vice president of the UK medical division
at GlaxoSmithKline, told the health select committee that the Yellow
Card scheme "doesn't work" and should be re-examined.
The
ABPI proposed that the Medical and Healthcare Products Regulatory
Agency should receive more funds for drug safety monitoring and
should regularly publish Yellow Card data.
Responding
to concerns that it uses 'ghost writers' to write clinical papers
on behalf of researchers, the ABPI stated: "As in many other
contexts, it is common practice for specialist medical writers to
raise the quality of publications through their skills in language
and communications, expertise in presenting data, understanding
of publication guidelines and convention, and/or time.
"But
the industry does not support the presentation of reports that do
not reflect the considered views of the stated authors. No serious
investigator would risk their reputation by simply adding their
name to a paper."
As
for allegations that drug firms effectively bribe doctors to prescribe
drugs with gifts and hospitality, the ABPI stated its code of practice
"requires that gifts to healthcare professionals must be relevant
to their work and never above the value of £6, and that hospitality
must be secondary to the purpose of any meeting and not out of proportion."
Nevertheless,
the ABPI added it is reviewing its code.
The
select committee, chaired by Labour MP David Hinchcliffe, is expected
to publish recommendations from its inquiry by the end of March.
Read for
yourself:
Submission
by the Association for the British Pharmaceutical Industry to the
Health Select Committee inquiry into the pharmaceutical industry
See also:
Dec
6, 2004: No evidence that SSRI antidepressants likely to increase
suicidal behaviour, watchdog announces - guidelines also issued
for treatment of depression
Nov
16: Reform of system for regulating psychiatric drugs outlined by
ministers - Commission for the Safety of Medicines members can
not have interests in pharmaceutical industry.
Oct
21: Professor of psychological medicine claims half of journal articles
written by those with interest in selling researched drugs -
health select committee also told drug firms bribe doctors and "ghostwrite"
articles
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