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LETTER TO THE EDITOR |
Medical Oncology-Hematology Mt. Vernon, New Hampshire, USA e-mail: Bonnem{at}pol.net
TRUST FACTOR
To the Editor: I read your recent editorial "Trust Factor" and wished to comment [1]. For many years, I worked within both a large pharmaceutical company and later, within small biotech companies. I have no doubt that there are some biotech companies which, under the pressure of Wall Street, will do some of the things alluded to in your article. However, your editorial fails to discriminate between the behavior of a few and the behavior of the much larger group of ethical and well behaved within the pharmaceutical industry.
Many small biotech companies have no business doing clinical trials, and many of them are nothing more than outgrowths of university professors who suddenly find themselves running a company. They have no idea how to organize a clinical trial or what it takes or what the Food and Drug Administration (FDA) or the medical community is seeking.
When I worked in a large pharmaceutical company, we actually had planners—people who got paid to do this—to estimate the time from idea in head to Institutional Review Board review to document gathering to first patient being treated, and so on. And, in turn, looking over their shoulders were a group of compliance people who wanted everything done according to the regulations. The counterbalance to "short cuts" was, therefore, quite great and not mentioned at all in your editorial.
For the vast majority of your readers, they do not discriminate between a small biotech company with a great deal of näiveté and the larger pharmaceutical companies who are quite sophisticated. I do not think that your reaction fairly characterizes much of the pharmaceutical or biotech industry anymore than it would be fair to characterize the recent events with Enron as being representative of the commercial world of oil, any more than the events with National Surgical Adjuvant Breast and Bowel Project (NSABP) several years ago would characterize the cooperative group system. The errant behavior of one physician in Montreal did not bring down or undermine the trust of the cooperative group system.
In a similar sense, the errant behavior of a few should not lead to a massive characterization of an industry that has placed so many products in the hands of treating physicians which otherwise would still be sitting in a laboratory. Therefore, your "trust factor" was and remains in place for the vast majority of those on the industry side just as the trust in the cooperative group system remains in place.
Many of your prescriptions for repair are already in place in most companies. The issue of fraud is why the FDA has legions of inspectors to prevent such things from ever happening. To their credit, they do their own audits of the data and source material. The issue of proper review is also in place in most companies.
Rather than cast doubt on an entire industry, would it not be better to hand out a "contract of expectations" to small companies who come in? Such a contract would say something to the effect that this is the procedure and this is how long it takes etc., etc., and serve to educate them. It manages their expectations when often those expectations are unrealistic from a lack of experience coupled with pressure from the financial gurus.
Your editorial, while reflective of recent events with ImClone and probably accurately reflecting some of your experiences with small companies, seems a bit harsh and unfairly characterizes an industry in which there are many who do indeed follow the rules and who do so carefully.
Please do not create the illusion of a trust problem when a few errant groups behave as suggested in your editorial. The sum of the whole in terms of the partnership that exists between industry and academia is greater than the individual parts alone.
REFERENCES
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