The Trust Factor: Editorial

EDITORIAL

The Trust Factor

Bruce A. Chabner, M.D., Editor-in-Chief

The Oncologist

I believe that most of us trust what we hear at talks and read in journals from our colleagues in oncology. We exercise our own judgment about the reliability of the data and their meaning, but, allowing for honest mistakes, we trust the good intentions of those in our field.

However, with growing regularity, those of us engaged in clinical research find our institutions and our field deeply engaged with a private sector that has at times different motives and agendas than our own, and different standards of public representation.

As Harold Varmus stated in a recent editorial in The New York Times (reprinted in February's issue of The Oncologist) [1], there is an inherent tension between the aim of researchers to discover the truth and the need for companies to sell their product, raise the price of their stock, and make money.

Thus we find ourselves dependent on the biotechnology industry for access to interesting new products and for financial support for clinical trials. We become invested in the success of those products. At the same time, we have little control over industry actions in promoting the product and a company's prospects to the investment public.

My own recent experience in this regard is instructive. Most of my interactions with industry have been very positive, and have focused on determining the clinical value of a new product.

At times, however, I have had less than positive experiences. I have been told by one biotech favorite to expedite review of a protocol because the investors are anxious to see the new product in the clinic, and "the stock is falling" as time passes.

I have been pressured by colleagues to speed up, change, or forget about scientific review of new protocols, because companies do not like to deal with our ponderous system. I have seen recent corporate announcements that obfuscate negative results by associating them with positive outcomes from unrelated trials.

On the public side, we have all witnessed unnecessary hyping of the newest molecules and targets based on preclinical experiments. The public and the investment community are slow to learn the most important principle in cancer biology, that man and mouse are not the same, and that most things that work in mice fail in man.

The rise and fall of ImClone, and the attendant publicity, represent perhaps the most visible example of the increasingly high profile nature of research in cancer therapeutics. Amid front page stories, TV features, and billion dollar corporate investment, the company and its lead product became the darling of Wall Street and then its whipping boy when the Food and Drug Administration rejected this novel and potentially valuable agent.

In the aftermath, a disappointed and angry investment community, cancer patients, and the public at large feel misled by corporate claims of success. There is a real danger that, in the backlash, the field of clinical oncology in general will be damaged, and public trust in our enterprise will be eroded.

In the case of ImClone, the pity is that the laboratory research on monoclonal antibody C225 has been nothing short of spectacular, and the drug itself is likely of significant value. We have work to do if we are to win back that most precious of all commodities, public trust.

How are we to repair the damage? We must be careful to separate our academic mission, to cure disease, from the interests of our corporate collaborators. Our partners in industry must respect the importance of the process of scientific review of proposed studies. The rules of scientific review and approval of protocols, free of conflict of interest, must be adhered to by our institutions, even in the face of corporate pressure.

Individuals must be willing to speak out against any incursions into this process. The use of "quick fixes" to the problem of scientific review should be resisted, including most pointedly the "IRB-for-hire" concept.

Additionally, we must actively monitor any attempt to exploit or misrepresent our research findings, and their implications. As researchers, we need to keep a low profile until we have certain proof of success. We must refrain from over-representing the importance or relevance of preclinical experiments or the data of early clinical trials. We can no longer disregard the potential for the major financial impact of what we say to the press or to TV reporters.

Our major corporate collaborators have been reliable partners with academia in the past, and the progress in cancer chemotherapy is evidence of the success of that partnership. Going forward, we will continue to need corporate, and especially biotechnology partners, no doubt, but they need us as well, and in the long run, respect for a process that seeks the truth will benefit all of us, including most importantly our patients.

The trust invested by patients in their caregivers and in the research-intensive drug industry is, after all, the most sacred trust.

The Oncologist, Vol. 7, No. 2, 94-95, April 2002 2002 AlphaMed Press

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