Vol. 1 Issue 1

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From Bench to Bedside:  A Useful Formulation?
By Paul Roman

From the perspective of what I have learned over 40-plus years in the substance abuse treatment field, I realize that my vision of the Dupont chemist working carefully and confidently to make my life easier and happier was a bit simplistic.  My imagery did indeed ignore the concept of technology transfer.   Between the scientist’s “bench” and the patient’s “bedside” there is indeed a very wide space…a gap, a breach, or even a chasm, according to the titles of books and articles that have recently flooded health care libraries.  Understanding what may or may not be in that space is more complicated that many would seem to believe.

Thinking about the new ideas and practices that have become prominent in substance abuse treatment, understanding seems simple.  Let's just assume the process indeed begins with a white-coated scientist, or more likely, a team of such women and men.  The example that is easiest to follow here is that of medications that have been developed to aid in treating addiction.  On the basis of previous research, and sometimes following intuition, scientific teams experiment with the impact of chemicals on simulated addiction-related behavior of "lower" animals. 

When adequate evidence has accumulated regarding the desired impact of the chemical, and when the relative safety of the use of the chemical has been established, it is administered to human subjects.  As an example, let us assume that a research team has discovered a chemical that appears to reduce the desire for repeated dosages of cocaine, i.e. what clinicians call cocaine dependence.  Let us assume the administration of this new medication has worked in both animal and human subjects and has produced results in the desired direction that are statistically significant.

This would appear to be the point of breakthrough, and any of us reading about these results in the media would be excited to learn that a major step forward in treating cocaine dependence has been established.  In point of fact, it is at this point that many drug developments stop.  Without being exhaustive, let's look at just two sets of barriers that could have come into play.  The first can be called “physical” barriers, while the second can be labeled “primary organizational” barriers.

- Physical Barriers -

It may be that the proposed medication that has proven effective in these experiments is extremely expensive to either obtain in nature or to synthesize.  This is a definite show-stopper, but may just be a show-postponement if it encourages research oriented toward more efficient and less costly means to produce the medication.

Other possibilities:

  • It may be that this particular proposed medication, while feasible to produce, is chemically unstable and has a minimal shelf-life, making transport and storage difficult, as well as raising the possibility that patients may receive dosages that have lost their effectiveness. 
  • It may be that in order to obtain the desired effects of reducing craving for cocaine, both animal and human subjects were shown to require frequent and large doses of the medication.  Succeeding with such dosages in the normal context of outpatient care creates significant challenge unless the use of the medication itself is or can be made to be rewarding.
  • Finally, it is not at all unlikely that when the medication was administered to human subjects over a longer period of time than was available in the clinical trials, frequent and/or unpleasant side effects came into evidence.

- First Stage Organizational Barriers -

Assuming that the physical barrier problems did not arise, numerous other steps are necessary before the proposed medication could find its way to the hypothetical bedside.  These matters are, at the next stage, largely regulatory, requiring detailed documentation of repeated clinical trials before a drug can receive federal approval.  But preceding the process of meeting the regulatory requirements are requirements of financial sponsorship and support for the trials.  After completion of the trials and Federal approval,  there must be substantial financial commitments from one or more commerical organizations for manufacturing and effectively marketing the medication to the target community.

Following the time of discovery at the “bench,” there is usually a very long delay before a medication effective in the treatment of substance abuse reaches the point of manufacture and marketing. Health services researchers and practitioners specializing in substance abuse do not generally begin their efforts until the medication has reached this stage. This is the stage where most of the actions associated with technology transfer and carried out by the ATTC Network and others commence. Here we face many issues associated with education and persuasion, as well as providing experiential satisfaction for the organizations and individuals who are expected to adopt and use these new practices. We also face the issue of financing the use of these new practices. Finally, if all else is successful, we hope that the use of the innovation can be sustained until such time as a new and better evidence-based practice appears on the scene. We might consider these issues to be “second stage organizational barriers” that center around adoption, implementation, and sustainability in treatment delivery organizations.

While the “bench to bedside” is a temptingly simplistic concept, it is important to understand that there are many other challenges between the bench and the bedside other than the ones that we have been addressing.  Thus, the matter of moving quickly from bench to bedside is an appealing and attractive myth.  It is not only a myth for the substance abuse treatment community, but also a myth in practically every other area where technology transfer is an issue.  Looking at this vast range of issues is among the aspirations of this new publication.

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