The polio vaccine: Fast is good, isn’t it? The polio…
Everybody lies says the neurotic Dr House when a very unlikely diagnosis would only make sense if someone were not telling the truth. “Clinicians realize that making an accurate diagnosis relies on the provision of reliable information by patients and their family members and that timely, astute, and compassionate care depends on effective bidirectional communications (between the patient and the physician).
Unfortunately, both patients and physicians are often challenged by complicated communications; each group withholds, distorts, obfuscates, fabricates, or lies about information that is crucial to the doctor-patient relationship and to effective treatment. What doctors reveal, withhold, or distort matters greatly to their patients. Such untruths and manipulation of information can damage relationships and compromise clinical care. Further, information exchanges are increasingly (via e-mail and medical records) electronic; fewer face-to-face interactions make communication even more challenging. Managed care and time constraints add further pressure.
People lie for a variety of reasons, including the avoidance of punishment, for preservation of autonomy, for aggression/power, for the delight of putting one over on another, for wish fulfillment, for furtherance of self-deception or repression of conflict, for manipulation of others, for the accommodation of the self-deception of others, to assert one’s sense of self, to maintain self-esteem, and to solve role conflicts. In the clinical encounter, themes of exploitation, protection, and shame predominate.
Philosophers have long argued about lying. St. Augustine says lying is both illegal and inmoral. Immanuel Kant’s premise is that truth telling is a moral duty and that lies would eventually become self-defeating as people learn that they cannot rely on the word of others (lying in even the most seemingly justifiable is wrong).
Others, however, have taken a less definitive position on deception. Accordingly, lying can be thought of as a normal part of human development and may even be adaptive in certain situations. For example, utilitarians have viewed lying as more or less justifiable according to the goodness or badness of its consequences. Similarly, the philosopher Sartre argued that there is no universal law to guide choices (eg, in matters of truth and deception).
Why do Physicians lie? Physicians selectively use information exchanges as part of a therapeutic regimen. Doctors cite reasons for limiting such exchanges and for not wanting to confuse patients, to cause unnecessary pain, or to eliminate hope. In such circumstances, the altruistic desire to do no harm may conflict with patient´s autonomy; it may be unclear whose feelings are actually being protected. In addition, physicians may lie to displace culpability for poor outcomes or to deny their ignorance or powerlessness to control disease processes.
Physicians also lie to respond to intense competitive pressures. Lying may help a physician avoid interpersonal or intrapsychic conflicts or difficult topics (eg, talking openly about disability or death). Prevarication may also represent an effort to encourage a particular treatment agenda. Sadly, there are also cases in which physicians exploit patients (eg, sexually or financially).
Why do patients lie? Patients lie to avoid negative consequences, to achieve secondary gain (eg, to obtain medication or disability payments), out of embarrassment or shame, or to present themselves in a better light (eg, as dutiful and compliant). While the full spectrum of what drives a patient or a physician to lie is extensive, several schools of thought make important contributions to our understanding. (1)
The above concepts are related to practical medicine.
And what about clinical trials?
Do doctors lie? Yes, several cases that back up this asseveration.
How and why do the investigators lie? In many ways and for different reasons and this kind of behavior receives the name of misconduct.
Is Innocent Ignorance or Malicious Malfeasance? Both of them. “The famous compliance Advisor, Mr. Stan Woollen, the former FDA Advisor, proposes the following “misconduct scale”
a) Innocent Ignorance- misconduct of the uninformed kind
b) Surprising Sloppiness- misconduct of the lazy kind
c) Malicious Malfeasance- misconduct of the sleazy kind (usually noncompliance due to deliberate action to deceive or mislead. That includes the F word of Fabrication, Falsication and Fraud”. (2)
“David B. Resnik, J.D., Ph.D., and David J. McCann, Ph.D. say “Regulations and policies of federal agencies and academic institutions prohibit misconduct in research, including data fabrication and falsification. These rules, however, focus exclusively on researchers and their institutions. If a research participant fabricates or falsifies his or her medical history to qualify for enrollment in a study, that behavior would not violate federal rules or institutional policies.” (3)
How would the research participants like to lie? Because it was said above ”lying is a normal part of human behavior and may even be adaptive in certain situations”.
“A recent study by Devine and colleagues suggests that misconduct by research participants is a serious problem in clinical trials that provide financial compensation (e.g., for a participant’s time and inconvenience)”.
The investigators surveyed 100 people who had participated in at least two studies in the past year or at least four studies in the past 3 years. Twenty-five percent admitted to exaggerating symptoms in order to qualify for enrollment in a study, and 14% admitted to pretending they had a health problem that they did not have in order to qualify for enrollment.
In addition, participants admitted that they failed to disclose important information, including concurrent enrollment in another study (43%), health problems (32%), prescription drug use (28%), and recreational drug use (20%). Failing to disclose requested information is not the same as fabricating information, but it is nonetheless deceptive.
Some people participate in research to earn money and may have economic motives for deceiving investigators. Indeed, the survey by Devine and colleagues suggests that such motives are the main reason why frequent clinical trial participants deceive investigators.
Other participants may deceive investigators because they are embarrassed to disclose information pertaining to sexual abuse, mental health problems, or illegal activities (such as recreational drug use).
Fabrication or falsification of information by research participants can undermine the integrity of a study by biasing the data.
As a result, pharmaceutical companies may inappropriately continue or discontinue the development of new medications, without having the precise data.
Similarly, results related to safety could be affected if healthy prospective participants falsify their medical history to qualify for a study.
Failure to disclose requested information could also affect safety-related study outcomes. And if a participant fails to disclose that he/she’s taking an investigational product as part of another clinical study, a serious adverse event could be attributed to the wrong compound.
Off course, study participants may also place themselves at risk when they fail to disclose important aspects of their medical history, fabricate a medical condition, or inaccurately report symptoms.
There are several strategies investigators can use to address the problem of deceptive behavior by research participants.
They can use physical exams and laboratory tests (specific for each protocol for instance measuring some drugs level) to verify information disclosed by participants.
If investigators obtain evidence during screening that a participant has failed to tell the truth, that person can be excluded from the study
Finally, investigators could require participants to be listed in a clinical trial participant registry that maintains records of study enrollment. Such a database can be used to check for current enrollment in other studies and to ensure that an appropriate washout period has passed since a previous medication study.” (3)
National registries could play an important role in promoting research integrity and protecting subjects from harm. Therefore the Investigators, the Ethics Committees, the Sponsors and CROs should ask the regulatory authorities for the creation of these registries.