Pharmaceutical physicians companies

Although, like statistics, the details of pharmacokinetic analysis are best left to the experts, a pharmaceutical physician who is familiar with the basic concepts of how pharmacokinetic information contributes to a dossier will be able to interact more effectively with company colleagues and regulatory authority staff, it is the aim of this chapter to provide such a preliminary grounding. 

This section aims to provide sufficient information for the pharmaceutical physician to effectively prepare and support a clinical trial. However, clinical trials come in many forms and what is appropriate for a single-centre non-sponsored trial is totally inappropriate for a multicentre global study sponsored by a big pharmaceutical company or institution. Similarly, a Phase 1 non-patient volunteer study... 

Laboratory safety data When the CRFs arrive at the data manager s office, questions will arise relating to laboratory safety data. Queries may occur at the investigator site and advice can be requested from the pharmaceutical physician associated with the clinical trial in the sponsor company. 

The medical department is usually headed by a senior pharmaceutical physician (the medical director), who is supported by a team consisting of other physicians, graduates and administrative staff. The non-medical graduates are normally pharmacists or life scientists and, in addition to providing informed scientific input, may look after some administrative areas. In some companies they, rather than the physicians, may be responsible for staff management, thus allowing the physicians to concentrate on their advisory roles. 

It is expected that, before entering the industry, the physician has acquired a good base of medical knowledge and broad clinical experience. However, pharmaceutical physicians are not usually employed for their clinical expertise because although some retain honorary clinical posts, with the consent of their employing companies, this is rarely sufficient for them to remain clinical experts and clinical advice is best sought from current full-time clinicians. On the other... 

There are certain personal attributes over and above a medical degree and clinical experience that make for a successful pharmaceutical physician. To be valued, the pharmaceutical physician must be able to provide insight into the clinical benefit, and hence the commercial potential, of a compound at any stage in its development. He or she must also have the planning skills to realise that potential, and an ability to communicate at all levels, both inside and outside the company. If the medical department is to act as the compan)r s medical conscience (see Section 10.2),... 

The ratio of pharmaceutical physicians in each area is approximately 1 4 8. In some small companies, a physician s responsibilities may extend across more than one of these areas. In larger companies, clinical pharmacology is likely to be the responsibility of the research part of a company, while the medical-services function resides within local operating companies. 

The medical director is, of course, not only a senior pharmaceutical physician but a senior manager and needs to be fully conversant with all the issues facing the company and understand all the principles and procedures which... 

It is undoubtedly difficult for pharmaceutical physicians, even up to the level of medical director, to have an all-seeing eye as to the perceptions that may prevail in the minds of the recipients of promotional material. What may be entirely clear to the informed approver of material may be entirely unclear in the mind of the uninformed or even informed recipient. After all, if the recipient is misled, no defence is possible that says that material is not misleading. It really is essential for the approver of promotional material to stand back and say to him/herself Is what we say capable of misleading or being misimderstood . As an Appeals Board member, I would say that at least half the complaints that come to the PMCPA relate to Clauses 7.2, 7.3, 7.4 and 7.10 of the Code. These relate to accuracy, balance, fairness, objectivity, lack of ambiguity and the full reflection of the total and up-to-date evidence comparisons must be carefully and appropriately presented information claims or comparisons must be capable of substantiation. So often defences presented by companies are ill-prepared and... 

The pharmaceutical physician has an important role to play in the training of representatives, who are required to have gained significant expertise with respect to their products and the manner in which they are promoted. The ABPI requires of member companies that all medical representatives are professionally trained imder the Code of Practice, and are required to pass an examination set by the ABPI within 2 years. The pharmaceutical physician will generally be asked to teach representatives sufficient imder-standing of the diseases (and their conventional treatment) to which the compan) s products are relevant. He or she will be familiar with the clinical data for the product(s), and the published and impublished reports and manuscripts, and can therefore teach the representatives about the issues that are important for the proper discussion of the product characteristics when the representative meets the prescribing physician. 

As a pharmaceutical physician, one has to be alert to the modern methods of publication of information that, by virtue of industry sponsorship, then becomes promotional in nature. One is wise to review material, both written and verbal, that is to be disseminated as information or a service to medicine. The rules require that such items report the data fairly and without bias and that if made available in support of a product as information or promotion, the relevant rules are observed (see below Section 12.5). Companies have been found in breach of the Code of Practice when so-called independent speakers of known opinion have been used too frequently in support of a product. 

The pharmaceutical industry presents many new challenges to such a person which include the interface with pharmacy and pharmacology, toxicological research, human volunteer studies, clinical trials and post-marketing surveillance to name just a few. Product safety is a factor which impacts on all of those endeavours and the pharmaceutical physician will be expected to work and provide advice within that framework. It will be clear to anyone that evidence of lack of safety in a medical product is not good news for the company concerned and that some level of protective action will often be required which in extreme circumstances may involve product withdrawal. It is, therefore, essential that the pharmaceutical physician should be absolutely clear what constitutes lack of safety in relation to the intended use of the product. 

There has never been any incentive for the pharmaceutical industry to pursue research along these lines even though, as in the case of Vioxx, the end results of neglecting adverse effects may be very costly. The aim of the industry has usually been to extend the market size irrespective of potential risk and attempts to implement effective post-marketing surveillance has received little enthusiasm. It is to be hoped that company medical departments and pharmaceutical physicians will continue to support the need for a broad range of safety evaluation studies to be conducted on new medicinal products. 

The most familiar story of a new and unexpected adverse effect starts in a dense fog of uncertainty. The pharmaceutical company may have received a few reports from doctors or other healthcare workers, there may be a letter in the medical press describing six or so cases of a suspected adverse effect or the regulatory authority may tentatively draw attention to a possible problem. The pharmaceutical physician may, quite reasonably, assess the small number of reports... 

Most (if not all) companies within the pharmaceutical industry have recognised that such requirements are now a permanent part of doing business, and are developing internal health economics expertise, both on a global (corporate) and on a country-specific level. It should be noted that because of the multidisciplinary nature of this area of research, pharmaceutical company-based health economists cannot operate in isolation from the other disciplines within the company. It is therefore vital that pharmaceutical physicians understand the basic principles of health economic evaluations in order to work with the health economists in the development of high-quality analyses. 

Doctors working with the pharmaceutical industry as pharmaceutical physicians are encouraged to undertake training in pharmaceutical medicine which is the medical discipline or speciality which encompasses their work in medical departments of the pharmaceutical and related healthcare companies, in clinical research units and regulatory bodies. Courses covering general and specialized aspects of pharmaceutical medicine have been established for many years in a number of European countries and elsewhere around the world. 

Training opportunities currently available and recommended for pharmaceutical physicians in the international field of pharmaceutical medicine in a global industry have increased enormously in recently years and space available here cannot possibly cover them all exhaustively. A recommended source of specific training opportunities originates from the professional bodies that support, deliver and endorse training opportunities. Many commercial training companies run competitive alternatives, and the trainee is advised to consider all the options that appropriate to their individual training as well as experience of others. 

Pharmaceutical physicians in large pharmaceutical companies will only very rarely be exposed to the need for press releases concerning their clinical trials. In contrast, the small entrepreneurial pharmaceutical company may live or die on the outcome of a single clinical trial. The rapid dissemination of the results of such a clinical trial to the appropriate audience (shareholders and investment community) is legally required when material to the prospects of a small, public company. The press release then becomes an important tool for publishing clinical trial results. 

The circumstances in which a pharmaceutical physician will personally be sued under the civil law are relatively infrequent. The individual doctor or pharmaceutical physician, who is usually an agent of the company, does not fall within the definition of a producer or manufacturer , although the pharmaceutical company usually will. Therefore, the individual pharmaceutical physician is unlikely to have proceedings brought against him or her personally, except in rare circumstances. It is much more likely that the company will be a defendant to an action by an individual patient or by another company, whether in tort or in contract. The deeper pockets of the company, in comparison to the individual pharmaceutical physician, practi-... 

Fortunately, instances where pharmaceutical physicians face criminal prosecution are rare. There are a number of specific ways, however, in which the criminal law can affect pharmaceutical companies and their physicians. One significant area is in the regulatory context, which may vary from country to country. For example, in the United Kingdom, the Medicines Act of 1968 creates some statutory offences, such as providing false information when applying to license a product. 

The pharmaceutical physician will be very familiar with certain types of contracts, depending on his/her role within the company. Examples include agreements with contract research organisations, contracts for the sale of the finished pharmaceutical product and licensing or distribution agreements. 

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