Memorandum submitted by Lois Rogers, Medical
Editor, Sunday Times (PI 116)
I have offered below, some broad comments on
the subject headings being considered by the committee. This is
purely to give a sort of shorthand overview of the concerns that
I think are felt by the public:
DRUG INNOVATION
There is a concern that this may be driven more
by profit than need. Lifestyle products with large potential markets,
may be looked up more favourably than research for cures for killer
diseases. The best-selling drugs in Britain are cholesterol-lowering
tablets, stomach ulcer and blood pressure drugs. These conditions
could be largely avoided by changes in lifestyle. There is currently
a lack of innovation in the pharmaceutical industry. Of 487 new
products proposed for licence applications in America since the
late 1990s, the Food and Drug Administration ruled that more than
three quarters of them were unlikely to represent improvements
over drugs already on the market, and the majority of them were
merely reformulations of existing products.
THE CONDUCT
OF MEDICAL
RESEARCH
There is felt to be a suppression of neutral
or negative findings, and data is manipulated to present results
in the most favourable light. Few people understand the way statistics
are presented. Devices such as confidence intervals, used to validate
statistical findings, appear to be subject to reinterpretation.
There is an impression that epidemiology is used to sustain bogus
arguments. For example, research is often presented as impartial
when it is not. Sales of a painkiller called Bextra rose by 60%
in 2002, following publication of research results in the Journal
of the American Dental Association. It later emerged the study
had been planted by the manufacturers Pharmacia, and was actually
commissioned from an offshoot of an advertising agency. It was
also promoting the unlicensed use of Bextra for an additional
unapproved condition.
THE PROVISION
OF DRUG
INFORMATION AND
PROMOTION
There is a concern that dissemination of information
about medicines and the way they are promoted, is open to abuse.
There are any number of examples of this, but the promotion of
testosterone patches for female sexual arousal disorder, is a
case in point. The licence application for the drug was recently
rejected by the Food and Drug Administration in America, but its
manufacturers Proctor & Gamble, intend to resubmit the proposal.
Although they plan at first to market the patches only to post-menopausal
women who have had their ovaries removed, large numbers of articles
have appeared in the media reporting the general problem of "hypoactive
sexual disorder", or low libido, and the potential of testosterone
patches to treat it. Questions are now being raised about the
long-term risks of dosing women with testosterone—a hormone
which can cause raised cholesterol and heart disease—as
well as leading to the development of male sexual characteristics.
The promotion of anti-depressant drugs to treat
children has been equally questionable. Earlier this year a confidential
GlaxoSmithKline (GSK) document from October 1998, was published.
It revealed that results from two large clinical trials designed
to test the safety of paroxetine, marketed as Seroxat in Britain,
were "insufficiently robust" to convince regulators
to approve it for use in adolescents. One of the trials did not
demonstrate a statistically significant difference from placebo
on the "primary efficacy measures", and the other showed
no significant difference at all between the drug and the placebo.
The confidential GSK document said the results of the first trial
would be reported only as showing a "trend in efficacy in
favour of Paxil across all indices of depression". The results
of the second trial would not be published at all. Doctors admit
that much of their post-qualification education and information
comes from drug companies. The companies each budget an average
of £10,000 for marketing to every doctor in the UK. Marketing
is growing in importance possibly because of the lack of any new
real "wonder drug" to sell. 44,000 of GSK's workforce
of about 101,000 is in sales.The number of people employed by
American drug companies in research and development, has increased
by 2% since 1995. The number employed in marketing has risen by
59% in the same period
PROFESSIONAL AND
PATIENT EDUCATION
Funding for most disease awareness or treatment
campaigns, is provided by pharmaceutical companies with a product
to sell. Most medical research is funded by drug companies, which
drives the agenda of what are considered important health issues
and what sort of research is published in the scientific journals.
The British Medical Journal itself is distributed free to doctors
in Britain because it is subsidised by the drugs industry. The
health issues it highlights are widely reported by the rest of
the media, an effect which arguably distorts the public and professional
perception of the importance of different conditions, or their
prevalence in the population.
REGULATORY REVIEW
OF DRUG
SAFETY AND
EFFICACY
It is undoubtedly detrimental to the public
interest, and to the public's perception of impartiality in the
regulatory process, to allow a situation where the very great
majority of government advisors have direct financial links to
the manufacturers of products they are meant to be evaluating.
This system is under review and is in urgent
need of reform.
PRODUCT EVALUATION
INCLUDING ASSESSMENTS
OF VALUE
FOR MONEY
I am not sufficiently close to the process to
comment on this aspect of the select committee's investigation,
but I am aware of specific circumstances which have aroused concern—notably
the argument about the approval of the influenza treatment Relenza.
This drug was rejected by the National Institute for Clinical
Excellence for use in the NHS, but following a public debate about
the possibility of GSK relocating its scientific research base
outside the UK, the Institute decided Relenza should after all,
be purchased on behalf of NHS patients.
For informed members of the public, episodes
of this nature arouse suspicion.
| 
