ACCEPTABLE RISK by Robin Cook; G. P. Putnam's Sons, New York, 1994, 404 pages, $23.95. Audio Renaissance Tapes, read by Jill Eikenberry, Four Tapes, 6 hour abridgement, 1995, $22.95.
There is a risk in every order or every prescription we write. Since these are in the mainstream of approved items they generally represent acceptable risks for the patient involved; for a specific patient some are not acceptable. The risk benefit ratio must be discussed with every patient. It was perceived by the public that we were not doing this consistently and "informed consent" discussions became a legal requirement to make sure that patients understood and accepted the risks of a procedure or treatment.
For those of us who have done clinical research enroute to our subspecialty, very real risks always existed when we subjected our patients to new drugs or procedures. It was frequently a department wide discussion and decision as to whether the risks were acceptable risks. "Informed consent" in these cases was always a lengthy document. Sometimes new procedures have reduced risks, and are readily assumed to have acceptable risks. When we introduced fiberoptic bronchoscopy to Sacramento in 1971, the risks were immediately seen by patients and physicians as being less than with the prior rigid Jackson bronchoscope.
Robin Cook (MD, Columbia; Ophthy, Harvard,) takes us on a fictional, if not surrealistic, journey concerning the research and risks of a new psychotropic drug. The protagonist, Dr. Edward Armstrong, sets up a research laboratory in Salem, Mass in order to prevent Harvard from obtaining patent rights on his new drug discovery which he thinks will be the next generation after Xanex and Prozak. To obtain investors, Armstrong decides to legally bypass the 10-12 years of FDA red tape and decrease the average $200 million costs by taking the drug himself. He invites his colleagues and laboratory assistants to participate voluntarily. The drug, ULTRA, an alkaloid, is studied and modified. The hallucinatory effects are eliminated by altering the side chains. (But will this totally eliminate hallucinatory flashbacks when it is withdrawn?) It is found to have a positive effect on mood, works like a general tonic in combating fatigue (all the laboratory workers/subjects required less and less sleep), enhances clear thinking by improved long term memory (the workers all seem to even remember childhood phone numbers), and decreases anxiety. Is this a billion dollar drug?
Thus far, the above story on the book market would probably not replace Cook's ophthalmologist income. But he expands Acceptable Risks by revealing why ULTRA may not, after all, be the ultimate psychotropic drug since short term memory is impaired, and cortical societal inhibitions are removed. This allows the baser human, or reptilian urges to be played out at night and not recalled during the day. The doctors and researchers can't seem to remember how they got so dirty during the night, why their nails got grimy, how their bodies got scratched, why their night clothes are bloody, or why their bedrooms have leaves and twigs scattered about when they awaken in the morning. When pets are found dead, the Salem witch industry goes into high gear. Cook does a skillful job of weaving Salem witch stories with the various personality changes in the physicians and research workers. In the rush to get this drug to market, they failed to determine accurately when steady state is reached as ULTRA concentrates progressively in the midbrain, hindbrain, and limbic areas before this oversight is realized. The PET scans are then done more frequently but it may be too late.
The reader is called upon for considerable suspension of disbelief as Cook makes a case for a particular alkaloid having caused the hysteria and subsequent hanging of Salem witches. But then to have an eighth generation offspring fall in love with the researcher, to have the original house of a witch occupied by this eighth generation nurse after 300 years, to have all the records of 3 centuries, in one house... well, if you can suspend reality longer, you may just want to read this well crafted story.
Cook even gives us seven additional volumes to read concerning the background research he did for this book. These range from basic neurophysiology to the history of the Salem witches. This will probably be Doctor Robin Cook's 15th multi-million dollar medical thriller. He has obviously found an alternate form of income that far exceeds the usual practice income.