Select Committee on Health Minutes of Evidence

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:


  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.


  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.


  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


  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.


  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.


  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.

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