Editorial: Are You Underexposed?

By Len Monheit
[email protected]

As our industry evolves, it faces new challenges, that if well-anticipated and well-managed, will contribute to its growth and credibility. If poorly handled, industry's traction with the pharmacist and medical communities, as well as with mainstream consumers could be permanently stalled.

In business, the process of determining what not to present or communicate is as critical as making the decision about what specifically to present. If you're introducing a product or concept, you want to leave the audience hungering for more, if it's a science or technical topic, chances are you want to appropriately support your thesis will all pertinent information. In most cases, you will not divulge everything you have. You will present mainly those facts and details which support your argument - no more, no less.

We act in a similar fashion in many of our conversations - we don't feel this urge to undermine our own credibility by inserting disclaimers or qualifiers with every other sentence. We also take leaps as we skip from data point to data point in our arguments, and we generally leave the other person in our debate to refute or note contradictory evidence, without trying to do so ourselves. This works, when you're in an actual dialogue.

In our business environment, we are expected to be professional at all times, and to not misrepresent our status, our products, our science and our capabilities. Certainly as companies report financial information, they are expected to disclose anything important to the market and their shareholders. On the science side, they are expected to communicate positive, negative and neutral results and on a personal level, although this sometimes doesn't occur, researchers are expected to disclose associations, affiliations, funding sources and other potential sources of conflict of interest.

What you say or do not say obviously impacts both the content of the message ultimately communicated as well as the effectiveness of this communication - the impact it will have. We see evidence of this in the media treatment of the supplements industry, the focus on negative issues, and the persistent myth of the 'unregulated' supplements industry. Recent negative Vitamin E research, and the ensuing headlines has created an interesting industry dilemma. We are crying for more directed research on supplement efficacy, and whether we credit this latest research or not, as the volume goes up, so will the numbers of neutral or negative results.

The pharmaceutical industry has been under pressure for some time to more thoroughly disclose affiliations and conflicts, and with the recent focus on risks associated with Cox-2 inhibitors such as Vioxx, the suppression of negative or neutral results has become an important issue. As we strive to become more mature and science-based, these same expectations will be placed on this industry, and the scrutiny will only intensify. We've seen a heightened interest, within the sector, in the fine print of communications describing science and clinical studies.

Issues such as number of patients, study funding, credentials of organizations and scientists, outcome measurement, study parameters and quality are beginning to be of interest, certainly to industry colleagues and potential collaborators, but also to a more skeptical media, consumer population and the pharmacist and medical communities. We'd be terribly naive to think that this scrutiny will do anything but rise in the future, and presumably, companies are forming the scientific advisory boards and relationships with CRO's now that will position them best for this scrutiny.

From a policy standpoint, companies at Board level are likely contemplating how to deal with these disclosure-related issues. The financial they've always had to deal with, but now the scientific could become a significant business risk. As regulatory agencies increase scrutiny of claim substantiation, it's obvious that the burying of neutral, inconclusive or negative results will become a bit more difficult.

And certainly if we, as an industry, want to 'play with the big boys' we've got to eliminate all manageable 'skeletons in the closet' - it's just good risk management.

My crystal ball suggests to me that we'll begin to see more transparency and more disclosure, particularly among the industry leaders. There will continue to be 'industry's lower tier', secretive or outright misleading companies, who because of lack of enforcement initiative and the huge reward:risk ratio will keep on operating with murky practices in this area.

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