Chapter 3
1. Phase I is not designed to show whether the drug has an effect on cancer pain. It is designed only to establish that there are no unacceptable side effects of the drug and to establish the maximum safe dosage. The volunteers in phase I are not suffering from cancer or pain. Therefore, there is no harm in the subjects knowing that they are receiving the drug. Phase II, however, is designed to determine whether the drug really has a measurable effect on the pain felt by cancer patients. Pain relief is highly subject to psychosomatic effects, so a placebo group is needed to control for this effect. Otherwise, if patients reported that NoPain did not relieve their discomfort, the researchers would have no way of knowing whether this relief was due to a pharmacological action of NoPain or merely to a placebo (psychosomatic) effect.
2. Variation from patient to patient and atypical responses would have a strong effect on averages based on a small number of patients. Testing a small sample of people also may fail to reveal side effects and unusual responses that could affect a significant number of people if a drug is approved for the market and used by millions of people. Therefore, clinical trials must use a large enough sample that such responses have a high probability of being detected and individual variations do not greatly skew the data and lead to false conclusions.
3. NoPain is a palliative treatment because it is able to relieve patients’ pain and thereby make them more comfortable, but not able to cure or prevent their cancer.
4. Explain to Mae that U.S. regulations governing the safe development of drugs require years of clinical trials and the expenditure of millions of dollars before the drug company can market the product. Also, at any point during the process, the drug may fail to qualify for human use, in which case the expenses incurred during clinical trials may never be recovered. Even after a drug is approved, unexpected side effects can arise and force a company to withdraw it from the market. Therefore, drug companies must price a drug so as to recover the costs of its development, cover the risks of failure, and still make a sufficient profit to stay in business.
5. Available sterilization techniques include pressurized steam, dry heat, irradiation, and chemicals. The technique used depends on what equipment is available and how soon the sterile swabs are needed. Pressurized steam and irradiation are both relatively easy to accomplish with the appropriate equipment, and the sterilization process can be completed in less than 2 hours in most cases. Chemical sterilization, especially with alcohol and phenol, would not be suitable because it most often requires placing the item to be sterilized in direct contact with the chemical. In the case of cotton swabs, the chemical would then come in contact with patients’ skin.
6. Immunotherapy, chemotherapy, and radiotherapy are all used to treat cancer.
7. Although the hospital tries to minimize the presence and spread of infectious agents in many different ways, it is impossible to maintain a sterile environment in a hospital room. This infection probably occurred when the patient was exposed to a person carrying the infectious agent, such as another patient or a visitor, or the infectious agent may have been airborne.
8. The physician would most likely use an injection to rapidly produce a high circulating antibiotic concentration. For a more prolonged dose, the physician would probably follow the injection with oral medication to be taken at regular intervals.
9. International units provide a way of determining the response expected from a given amount of a compound. The biological activity of the same compound may differ based on the means of preparation. As a result, using the mass (weight) may not produce reproducible effects. Therefore, international units provide a means of producing a uniform response, regardless of the means of preparation.
10. Gastrotomy refers to an incision in the stomach. Gastrectomy means removal of part or all of the stomach. Gastroscopy means viewing the stomach, normally with an endoscope. Gastrocentesis means puncturing the stomach to remove fluid. Gastroclysis means irrigating the stomach with fluid.