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Chapter: Basic & Clinical Pharmacology : Development & Regulation of Drugs

Conflicts of Interest, Adverse Drug Reactions - Evaluation in Humans

Several factors in the development and marketing of drugs result in conflicts of interest.

Conflicts of Interest

Several factors in the development and marketing of drugs result in conflicts of interest. Use of pharmaceutical industry funding to support FDA approval processes raises the possibility of conflicts of interest within the FDA. Supporters of this policy point out that chronic FDA underfunding by the government allows for few alternatives. Another important source of conflicts of interest is the dependence of the FDA on outside panels of experts that are recruited from the scientific and clinical community to advise the government agency on questions regarding drug approval or with-drawal. Such experts are often recipients of grants from the com-panies producing the drugs in question. The need for favorable data in the new drug application leads to phase 2 and 3 trials in which the new agent is compared only to placebo, not to older, effective drugs. As a result, data regarding the efficacy and toxicity of the new drug relative to a known effective agent may not be avail-able when the new drug is first marketed.

Manufacturers promoting a new agent may pay physicians to use it in preference to older drugs with which they are more famil-iar. Manufacturers sponsor small and often poorly designed clini-cal studies after marketing approval and aid in the publication offavorable results but may retard publication of unfavorable results. The need for physicians to meet continuing medical education (CME) requirements in order to maintain their licenses encour-ages manufacturers to sponsor conferences and courses, often in highly attractive vacation sites, and new drugs are often featured in such courses. Recognition of the obvious conflicts of interest is leading some clinical specialty organizations to reject industry support of such conferences. Finally, the common practice of dis-tributing free samples of new drugs to practicing physicians has both positive and negative effects. The samples allow physicians to try out new drugs without incurring any cost to the patient. On the other hand, new drugs are usually much more expensive than older agents and when the free samples run out, the patient (or insurance carrier) may be forced to pay much more for treatment than if the older, cheaper, and possibly equally effective drug were used. Finally, when the patent for a drug is nearing expiration, the patent-holding manufacturer may try to extend its exclusive mar-keting privilege by paying generic manufacturers to not introduce a generic version (“pay to delay”).

Translational Research

Unfortunately, the rate of introduction of new drugs has fallen during the last two decades. This has raised concerns about our ability to deal with the increasing prevalence of resistant microor-ganisms, and the problems of degenerative diseases in an aging population. In an effort to facilitate this process, the National Institutes of Health are currently (2011) considering the establish-ment of a new institute specializing in translational research.

Adverse Drug Reactions

An adverse drug event (ADE) or reaction to a drug (ADR) is a harmful or unintended response. Adverse drug reactions are claimed to be the fourth leading cause of death, higher than pul-monary disease, AIDS, accidents, and automobile deaths. The FDA has further estimated that 300,000 preventable adverse events occur in hospitals, many as a result of confusing medical informa-tion or lack of information (for example, regarding drug incompat-ibilities). Some adverse reactions, such as overdose, excessive effects, and drug interactions, may occur in anyone. Adverse reactions occurring only in susceptible patients include intolerance, idiosyn-crasy (frequently genetic in origin), and allergy (usually immuno-logically mediated). During IND studies and clinical trials before FDA approval, all adverse events (serious, life-threatening, dis-abling, reasonably drug related, or unexpected) must be reported. After FDA approval to market a drug, surveillance, evaluation, and reporting must continue for any adverse events that are related to use of the drug, including overdose, accident, failure of expected action, events occurring from drug withdrawal, and unexpected events not listed in labeling. Events that are both serious and unex-pected must be reported to the FDA within 15 days. In 2008, the FDA began publishing quarterly a list of drugs being investigated for potential safety risks. The ability to predict and avoid adverse drug reactions and optimize a drug’s therapeutic index is an increasing focus of pharmacogenetic and personalized medicine. It is hoped that greater use of electronic health records will reduce some of these risks .

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