In the Independent on 8th December, Allen Roses was quoted as saying
that “The vast majority of drugs – more than 90% - only work in 30 to 50
per cent of the people.” The enormous media response to this remark
should serve as a warning to all those involved in the provision of
health care.
For many of the most lucrative drugs, the benefits of treatment are
of an order of magnitude less than the figures mentioned by the vice-
president of genetics at GlaxoSmithKline. For example, less than five per
cent of patients receiving long-term treatment with statins are likely to
obtain any benefit whatsoever.[1,2] Put another way, of every one million
pounds spent on lipid-lowering agents, more than £950,000 is wasted.
Imagine the media outcry to such a revelation?
But, even these miserably small benefits may be nothing but a
fiction, a statistical sleight of hand or – to use the current vernacular
– a “sexing-up” of the data by interested parties. For all the accolades
bestowed upon large-scale randomised trials, their methodology is deeply
flawed and their results are highly questionable.[2,3] Yet, patients
continue to be prescribed long-term treatment with expensive drugs with
little prospect of benefit, scarce health care resources continue to be
squandered, and those with a vested interest in the results of large-scale
randomised trials continue to promote their wares to a bemused – if not
frankly gullible - medical profession.
We are urged to “Let the sun shine in.” [4] If, as it seems, this is
a call for honesty and openness, then few would disagree. But, let this
honestly and openness extend to the foundations of clinical research. And,
of course, let those – including the editor of the BMJ – who endlessly
extol the virtues of large-scale randomised trials, bring honesty and
openness into the murky world of this flawed methodology.
References
1. Freemantle N, Hill, S. Medicalisation, limits to medicine, or
never enough money to go around? BMJ 2002;324;864-5.
2. Penston J. Fiction and Fantasy in Medical Research: the Large-Scale
Randomised Trial. The London Press. London, 2003.
3. Charlton BG. Fundamental deficiencies in the megatrial methodology.
Curr Control Trials Cardiovasc Med 2001;2;2-7.
4. Smith R. Editor’s choice: The drugs don’t work. BMJ 2003;327; 13th
December.
Competing interests:
None declared
Competing interests:
No competing interests
18 December 2003
James G Penston
Consultant Physician/Gastroenterologist
Scunthorpe General Hospital, Cliff Gardens, Scunthorpe, North Lincolnshire DN15 7BH
Rapid Response:
Let the sun shine in
Sir,
In the Independent on 8th December, Allen Roses was quoted as saying
that “The vast majority of drugs – more than 90% - only work in 30 to 50
per cent of the people.” The enormous media response to this remark
should serve as a warning to all those involved in the provision of
health care.
For many of the most lucrative drugs, the benefits of treatment are
of an order of magnitude less than the figures mentioned by the vice-
president of genetics at GlaxoSmithKline. For example, less than five per
cent of patients receiving long-term treatment with statins are likely to
obtain any benefit whatsoever.[1,2] Put another way, of every one million
pounds spent on lipid-lowering agents, more than £950,000 is wasted.
Imagine the media outcry to such a revelation?
But, even these miserably small benefits may be nothing but a
fiction, a statistical sleight of hand or – to use the current vernacular
– a “sexing-up” of the data by interested parties. For all the accolades
bestowed upon large-scale randomised trials, their methodology is deeply
flawed and their results are highly questionable.[2,3] Yet, patients
continue to be prescribed long-term treatment with expensive drugs with
little prospect of benefit, scarce health care resources continue to be
squandered, and those with a vested interest in the results of large-scale
randomised trials continue to promote their wares to a bemused – if not
frankly gullible - medical profession.
We are urged to “Let the sun shine in.” [4] If, as it seems, this is
a call for honesty and openness, then few would disagree. But, let this
honestly and openness extend to the foundations of clinical research. And,
of course, let those – including the editor of the BMJ – who endlessly
extol the virtues of large-scale randomised trials, bring honesty and
openness into the murky world of this flawed methodology.
References
1. Freemantle N, Hill, S. Medicalisation, limits to medicine, or
never enough money to go around? BMJ 2002;324;864-5.
2. Penston J. Fiction and Fantasy in Medical Research: the Large-Scale
Randomised Trial. The London Press. London, 2003.
3. Charlton BG. Fundamental deficiencies in the megatrial methodology.
Curr Control Trials Cardiovasc Med 2001;2;2-7.
4. Smith R. Editor’s choice: The drugs don’t work. BMJ 2003;327; 13th
December.
Competing interests:
None declared
Competing interests: No competing interests