Mysteriously, the hospital pushes forward with the study even though six patients have died since the start of the trial. Pescoe teams up with Clara Wong—a brilliant internist with a troubled past—to investigate the situation. Their inquiries lead them unwittingly into the cutthroat world of big-business pharmaceuticals, where they are threatened to be swept up and lost before they have the opportunity to discover the truth behind an elaborate cover-up.
With the death count mounting, Pescoe and Wong race against time to save the patients on the ward and to stop the drug manufacturer from unleashing a dangerous new drug on the general populace.
Alzheimer’s Disease, Clinic Trials, and the Novel Terminal Care by Christopher Stookey
Alzheimer’s disease is a devastating brain disorder that leads to memory loss and a steady decline in intellectual functioning. For people under the age of fifty, the disease is fairly rare. However, as people age, the disease becomes much more common. One in twenty people between the age of 65 and 74 will develop Alzheimer’s. By age 85, about half of all people will have the disease.
The hallmark of Alzheimer’s is a gradual progression of memory impairment to the point where a patient can no longer even remember the names of family members and loved ones. The patient becomes completely unable to take care of him- or herself. The disease, ultimately, is fatal.
The underlying cause of Alzheimer’s is still not completely understand. However, one thing is certain: the end result of Alzheimer’s is the death of neurons—brain cells. The overall size of the brain shrinks dramatically as the neurons die off. In Alzheimer’s disease, the brain literally shrivels up.
There is no cure for Alzheimer’s. However, because Alzheimer’s disease is so common and so devastating, efforts towards finding a cure are underway at many research centers. Alzheimer’s research is one of the most active areas of medical inquiry.
Right now there are dozens of clinical trials underway to test new drugs as treatments for Alzheimer’s. A wide number of different types of drugs are being looked at. For example, some researchers believe inflammation might be the cause of brain cell death in Alzheimer’s; consequently, clinical trials are underway to test the efficacy of anti-inflammatory drugs in treating Alzheimer’s. Other clinical trials are testing cholesterol-lowering drugs because there are theoretical reasons to think there might be a link between cholesterol and Alzheimer’s. Researchers are also studying antioxidants, certain vitamins, and females hormones as possible treatments.
Most clinical trials are designed in basically the same way. A group of people—the subjects of the trial—are divided into two halves. One half of the subjects get the new, experimental drug that is being tested. The other half of the patients get a placebo, that is, either a sugar pill or some other inert substance such as a saline (salt water) injection. The two groups are then compared in terms of some specific parameter. Thus, in a study of a new drug treatment for Alzheimer’s, memory tests might be given. If the drug group scores better than the placebo group, this is evidence the drug is working to improve memory.
The best clinical trials are those which go by the fancy title “randomized, double-blinded” studies. “Randomized” means subjects are put in the drug group or the placebo group in a random way. A simple coin toss could be used. More commonly a computer randomly put subjects into one group or the other (using a sort of computer-generated coin toss).
“Double-blinded” means neither the researchers conducting the trial nor the subjects, themselves, know who is getting the real drug and who is getting placebo. This may seem odd at first. How could scientists conduct a trial where no one knows who is getting what? Ultimately, of course, someone does know which subjects get the drug and which get the sugar pill. But this “someone” might be a pharmacist who is not otherwise involved in the trial or even a computerized drug dispenser. The “blinding” is done in order to avoid bias. Researchers who know which subjects are getting the real drug might tend to look upon such subjects with a more favorable eye. Subjects who know they are just getting a sugar pill, on the other hand, might not try so hard on, say, a memory test.
Once all the test results are in, then the researchers “break the seals” and reveal who is getting what.
Terminal Care is a novel about exactly this sort of drug trial. Researchers at a hospital in San Francisco are conducting a clinical trial to determine if the new, experimental drug, “NAF,” is a safe and effective treatment for Alzheimer’s disease. Half the patients on the Alzheimer’s ward are getting NAF and half are getting a salt water injection.
In good, scientific fashion, the trial is randomized and blinded. Neither the researchers nor the patients know who is getting NAF and who is getting placebo. Everything seems to be going well for the first six months of the trial, and then a problem starts to show up. The problem is patients on the ward begin to die off at an alarming rate.
The “seals” are broken early on the patients who die in order to determine if the deaths are occurring exclusively in the NAF subjects. The surprising answer is the deaths are occurring in both NAF subjects and placebo subjects. What, then, is really causing the subjects to die? This, ultimately, is the key mystery of the novel, and it takes two physicians who are not directly involved in the clinical trial—Phil Pescoe, an emergency room physician, and Clara Wong, an internist—to find the startling answer.
To find out more about Chris, visit his Amazon’s author page at http://www.amazon.com/Christopher-Stookey/e/B003UVLDI4.
This post first appeared at The Book Connection.