Select Committee on Science and Technology Seventh Report


  6.1     Another way round the problem of resistance is by using new drugs. This approach depends on the willingness of industry to invest in developing new products in this area; their success in doing so; and the ability to pay for any new patent medicines which emerge.

How hard is industry trying?

  6.2     Professor Reeves of the AMM is under the impression that the pharmaceutical industry are not currently investing much in antimicrobials, because the chances of commercial return are small (Q 28). Several other witnesses told the same story (e.g. Chopra p 402).

  6.3     The ABPI (p 175; QQ 314-320) tell a different tale. They acknowledge that the 1980s saw little investment in new antimicrobials. However this changed around 1990, partly because of the rise in resistance (market pull) and partly because of the "explosion of information" from bacterial genetics[62], coupled with technological improvements in drug testing (science push). "Most of the major pharmaceutical companies have invested heavily in the last five years or so in the antibacterial area", and antimicrobials are now the third largest therapeutic class in R&D, accounting for 20 per cent of pre-clinical research projects and 9 per cent of clinical development projects. It is more than 20 years since the emergence of the last major new class of antibiotics; but industry is now using genetics to look for new drug targets and modes of action, including modes of action which would either not give rise to resistance[63], or even possibly reverse it. However, new antiviral and anti-parasitic drugs are "lagging behind" antibacterials—with the exception of drugs against HIV. Three British pharmaceutical majors told us their own stories: see Box 10.

Box 10
Glaxo Wellcome (p 405)
Since 1996, anti-infectives have been one of Glaxo Wellcome's priority areas for drug discovery, with increased investment, particularly in bacterial genomics, which in their view will "fundamentally swing the pendulum back" in favour of anti-infectives.
In 1994 Glaxo Wellcome launched "Action tb", a programme for collaborative research worth £2m p.a. for five years.
Glaxo Wellcome are major contributors to the Edward Jenner Institute for Vaccines Research (see Chapter 8).
Glaxo Wellcome have agents under development against penicillin- and cephalosporin-resistant pneumococcus and staphylococcus; resistant Gram-positive pathogens and TB; and azole-resistant fungal infections.
SmithKline Beecham (SKB) (p 473)
SKB hail the genomics "revolution": but they point also to developments in chemistry (combinatorial chemistry, and biotechnology) which have vastly increased the range of chemicals available for pharmaceutical applications; and to developments in screening, enabling the new chemicals to be tested faster for effects on the new targets identified by genomics.
SKB themselves claim to have "led the pharmaceutical industry" in investment in genome sequencing; and now have a joint venture with Glaxo Wellcome to sequence bacterial genomes. They have recently given their own antibacterial research special status and dedicated resources, under the tag "Manhattan Micro".
Despite all this effort, SKB warn of a "vulnerability window between 2000 and 2007, in which multi-resistant organisms will increase in clinical importance without parallel progress in the introduction of new antibiotic classes".
Zeneca Pharmaceuticals (p 544)
Zeneca has a "significant investment" in anti-infective discovery programmes, based on genomics, but does not expect results for "many years".


  6.4     The Chief Medical Officer expressed satisfaction with the industry's efforts (Q 791): "The fact that there are not lots of new drugs coming out does not mean to say there is not a lot of work going on in this area and a great deal of investment". Professor Finch said, "[The pharmaceutical industry] have done a terrific job up till now, and maybe the new genomics is going to open up new approaches". But he warned, "We cannot always rely on [them] to come up with new agents" (Q 386).

Licensing: fast-tracking and "orphan drug" designation

  6.5     The ABPI called for accelerated licensing procedures, subject to the necessary safeguards, for "new antibiotics that are acting by completely novel mechanisms of action and are active against resistant organisms" (Q 325; cp SKBp 484). The AMM make the same recommendation (Q 60); and the Chief Medical Officer is in favour of speeding up the process (Q 792). Professor Finch told us that the United Kingdom Medicines Control Agency's procedure is now very fast, and capable of responding to an application within 3-4 months. The system can be made to work even faster, and has done so for certain HIV treatments. There is also scope for compassionate use in advance of licensing. The EU Medicines Evaluation Agency takes rather longer (QQ 377-380).

  6.6     If the prospective market for a new drug is not sufficiently large or wealthy to justify the cost of development, the drug is known as an "orphan". Professor Finch was unable to envisage many situations where a drug effective against a resistant infection would require orphan status rather than the normal licensing regime (Q 381). However the USA has a programme of incentives for orphan drugs, including accelerated approval and extended patent protection, and the EU is

consulting on a similar scheme. The ABPI support it (Q 327); SmithKline Beecham, in particular, recommend it as a way to encourage development of agents against tropical parasitic diseases (p 485); the AMM call for a United Kingdom scheme (Q 60), and Professors D A Mitchison (p 432) and A R M Coates (p 470) of St George's Hospital call for a scheme in respect of TB.

62   See the evidence of the Centre for Applied Microbiology and Research (CAMR) (p 395), which also usefully surveys the leading edge of completely novel approaches to antimicrobial resistance. Novel approaches are also the subject of the evidence of Professors Brian Henderson and Michael Wilson of the Cellular Microbiology Group, Eastman Dental Institute, University College London (p 413), and are noted by the Society for General Microbiology (p 493). On bacteriophage in particular, see the evidence of Dr J Soothill (p 510). On alternative approaches involving complementary medicine, see the evidence of the Research Council for Complementary Medicine (p 447) and J Hoare (p 420). See also Appendix 6, paragraphs 49-50. Back

63   This "disease-based" approach is described by Glaxo Wellcome (p 406). Professor Ian Chopra, Director of a new Antimicrobial Research Centre at Leeds University, specifically seeking to promote academic-industry collaboration in discovery of antibacterial agents, warns (p 402) that there are "no reports yet even of lead molecules". Back

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