Healthy liaisons with the drug barons

January 17, 1997

Frank Wells on the relationship between university research and pharmaceutical companies

There has never been a more important time for industry and academia to be working together. Industry needs ideas from academia and then a sound environment in which to develop those with potential. Academia needs support and funding from industry to encourage research in an appropriate environment and to see its successful ideas realised.

The relationship exists on several fronts. Pharmaceutical companies may provide whole university departments, such as the Roche neurosciences department at Cambridge, or may fund a personal chair, such as the Sandoz professor at University College, London. They frequently collaborate with university scientists in the early development of new molecules or place contracts with academic units for the conduct of clinical trials.

On all these fronts there is evidence of a better understanding of the needs and expectations of each other than used to exist.

The study of the way in which medicines are metabolised and affect the outcome of disease in human beings is the science of clinical pharmacology. Training in clinical pharmacology, however, was in the doldrums until recently. Academic clinical pharmacologists tended to train budding specialists in their own image. The end product was an individual unsuited for a career in industry or in a medicines' regulatory authority. Yet there was a pressing need for appropriately trained specialists.

Collaboration was called for to tackle training and a programme was devised with the unqualified support of both academia and industry, as well as the Departments of Health in England and Scotland.

Trainee clinical pharmacologists can now get two years' experience in an academic department, two years' work in the National Health Service and one year in the clinical pharmacology unit of a major pharmaceutical company. The trained doctor at the end of the five-year scheme, which has just started, will be pluripotential, finding posts available in academia, the industry, the NHS or equivalent elsewhere, or in a regulatory authority.

This scheme has proved to be very attractive and clearly demonstrates an effective working relationship between the disciplines involved.

For clinical trials involving patients, industry has for many years been required to conduct such studies to so-called "GCP" standards. GCP stands for Good Clinical (Research) Practice - as opposed to Good Manufacturing Practice (GMP) or Good Laboratory Practice (GLP) - and the guidelines setting out these standards are those issued by the European Commission, drafted by its committee on proprietary medicinal products.

This committee is the advisory body to the European regulatory authority, the European Medicines Evaluation Agency (EMEA), and the GCP guidelines clearly spell out the responsibilities of companies sponsoring studies, investigators conducting them and research ethics committees reviewing them. No company can afford not to adhere to these guidelines as it would be unlikely to obtain marketing authorisation for its new products if it did not.

Because these quite tough "rules" exist - and early next year the European guidelines will be subsumed by international guidelines agreed by the United States and Japan as well as Europe - the standards of the clinical research process, including the conduct of clinical trials, with which pharmaceutical companies readily comply, are high.

The Association of the British Pharmaceutical Industry (ABPI) produced guidance for investigators conducting clinical trials on its behalf some years ago, based on the requirements of the European guidelines.

It was felt that the 30 or so points that an investigator had to take into account should clearly be set out, not only for his or her own benefit, but for the benefit of colleagues so they could easily see the reasons why certain procedures had to be followed during the course of a clinical trial.

The danger inherent in creating two standards of clinical research - one complying with regulatory requirements, the other complying with no set guidelines at all - was recognised by the ABPI, the medical royal colleges, the British Medical Association and the Medical Research Council at their regular liaison meetings.

Consequently academia asked the industry, through the ABPI, to produce further guidance for investigators, based on the GCP guidelines, but leaving out the purely regulatory requirements demanded of pharmaceutical companies.

This guidance has now been available for two years, and has proved very popular, once again confirming the value of liaison and understanding between academia and the pharmaceutical industry.

The pharmaceutical industry is by now very familiar with the GCP guidelines, and has adopted a forthright policy in the UK for dealing with investigator fraud if it occurs. Any doctor who, beyond all shadow of doubt, has exploited patients or a pharmaceutical company and fabricated data with the intent to deceive, should be dealt with summarily by reference to the disciplinary machinery of the General Medical Council.

Rigorous application of this policy has led to a number of doctors being found guilty of serious professional misconduct for research fraud and admonished, suspended or erased from the medical register.

The policy could not have worked so well without the rigorous support of the leaders of the medical profession including the royal colleges and universities.

On other issues there is similar accord. For example, both academia and industry subscribe to and recognise the need for the highest standard of ethical review that can be provided by local research ethics committees.

Both sides have supported the initiative of Sir Kenneth Calman, chief medical officer of England, to find a solution to the problems created for multi-centre research projects by their having to be referred to every ethics committee in the area of responsibility in which an investigator practises. A system whereby the protocols of such studies can be considered by a single committee, leaving solely local issues to be determined locally, is a very sound concept.

Turning to the issue of genetic testing and gene therapy, both the industry and academia have stated their support for the Human Genetics Advisory Commission set up under the chairmanship of Sir Colin Campbell and on which the pharmaceutical industry will be represented by George Poste of SmithKline Beecham.

The pharmaceutical industry's future is likely to depend on the outcome of genetic research, biotechnology and processes yet to be discovered. That all this will to a great extent depend on the outcome of the research conducted in universities means that the greater understanding which now exists between industry and academia must be taken even further. The future, as the result of this, looks very exciting.

Frank Wells is former medical director of the Association of the British Pharmaceutical Industry.

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