Scientific Work in the Pharmaceutical Industry

Connecting medical education with Medical Affairs work.

Scientific work in the pharmaceutical industry belongs to a commercial organisation and is at the same time subject to the rules of scientific method. These two frames need not conflict; they conflict when the boundary between them is left undefined.

Separating the functions

Separating Medical Affairs from commercial functions protects which question a piece of scientific content answers: the scientific function answers "what does the data show", the commercial function "how is this product positioned". Where the two merge without distinction, a reader cannot tell which question was answered.

Obligations of transparency

What carries credibility in industry-supported scientific work:

• Registering the study before enrolment begins
• Publishing studies whose results are unfavourable as well as those that are not
• Stating the authors' access to data and their ability to verify the analysis
• Disclosing who held the decision to publish
• Declaring the funding source and any writing support

What these have in common is that none of them changes a result; all of them make a result independently appraisable.

Publication bias

The oldest criticism directed at industry-supported research is a tendency not to publish unfavourable results. Prospective registration answers that directly: a study registered but unpublished remains visible at least in its existence.

The quality of scientific exchange

Keeping an answer within the known data, not suggesting a use that has not been demonstrated, and saying plainly where data does not exist are what make exchange with a clinician scientific. "There is not enough data on this" is not a weakness of scientific communication but a requirement of it.

Separating education from promotion

Where the funding source, who determined the content and the speaker's relationships are all stated, educational content does not lose its value by having been supported.