Pretty eye-opening stuff right from the horse's mouth.
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=36747
*** quote ***
Increasingly, R&D and even clinical and scientific affairs functions
work more closely with marketing so that planned trials, selected
publications, and presentations support the brand and differentiate it
in the marketplace-from the beginning, not after the fact.
Communications specialists need to be part of development teams, so
that they not only can understand and easily explain the science but
also direct the process of communications influence.
That is not to suggest that public relations specialists should direct
the work of scientists and clinicians. But it is to strongly propose
that communications specialists provide guidance about how particular
trials may play in the public arena: that experts in media and
communications be allowed to decide how to highlight the science.
The launch of Celebrex (celecoxib)-one of the most successful
roll-outs in the history of the industry-proves just how successful
such integration can be. Celebrex is one of many drugs that relieve
the pain caused by osteoarthritis, which isn't much of a story. But
because of the way it blocks pain, Celebrex is less likely than
aspirin and other non-steroidal anti-inflammatories to cause
gastrointestinal bleeding. And that is a terrific news hook.
So the story of the science behind the product paved the way to the
successful launch. The discoverer himself also became a large part of
the story, and, by the time the product was approved, Searle and
marketing partner Pfizer were taking Celebrex into a marketplace and
to media primed with the science. It wasn't just the launch of another
pain killer; it was a triumph of scientific discovery made possible by
the integration of communications with the R&D teams.
Similarly, that kind of integration can prove incredibly effective in
the publication planning process. Left to its own devices, clinical is
often inclined to try to publish in what at first glance are the most
prestigious publications, such as the New England Journal of Medicine
and the Journal of the American Medical Association. But it may be
that publication in smaller, more targeted journals will reach
precisely the opinion leaders whom companies need to reach to make a
particular product successful.
Communications integration is not only vital in planning publication
placements, it must also be a part of trial planning. Again, that
doesn't mean that communications should drive science. It means that
communications specialists should help scientists and clinicians
clarify the messages they want to derive from trials. For the right
messages to emerge, the trials must be designed to elicit particular
kinds of findings. Such planning is particularly important in an era
when new products are far more likely to be slight improvements on
older products rather than significant breakthroughs.
*** end quote ***
The science is to be designed to derive the message needed for
marketing, for "the right message to emerge". "to elicit particular
kinds of findings".
One would think that the design of a study would be to ensure
scientific credibility and to determine, in a scientific credible and
definitive way, if a drug works or not. But I guess the idea really is
to design the research to "elicit a finding" that "allows the right
message to emerge" from the get go.
The research is to be designed to market the drug, not to determine if
it is safe and/or effective.
"Such planning is particularly important in an era when new products
are far more likely to be slight improvements on older products rather
than significant breakthroughs."
So much for the "experimental breakthrough drug" that's always being
developed in the wings, that's going to save countless lives, which
some people use to justify the behavior of pharma.
TC