Introduction

In phase 1 trials, small groups of healthy humans are the first to try investigational drugs. Some companies, like Eli Lilly, have gone to the fringes of society—the homeless–to find these subjects.

Background

In 1996, the Wall Street Journal,  and Desecret News, revealed that Eli Lilly hired homeless alcoholics for their phase 1 clinical trials.  As discussed by Desecret, subjects received thousands of dollars in compensation.  Lilly asserts that all its subjects were screened properly to prevent harm to them and the data.  While the interviewed subjects in the Desecret article did not experience side effects, phase 1 trials are not always so safe, as one “professional guinea pig” testifies in this Time video. According to the video and the article, some subjects do not honestly report medical history and side effects in the interest of getting their payment.

Concern

Was Eli Lilly’s payment of homeless alcoholics in phase 1 clinical trials considered coercive due to the subjects’ susceptible position?

The Declaration of Helsinki‘s primary purpose is to protect patient rights and interests.

Article 9 of the Declaration defines vulnerable populations as people who are in positions where they cannot make clear choices, especially in regards to consent, and may be easily affected by pressure from other persons. The Declaration’s

Thus, recruiting and testing homeless alcoholics would be a violation of the Declaration if they are:

  • vulnerable
  • likely to be coerced by the monetary compensation offered

Analysis

Vulnerability

  • Some subjects “participated in Lilly’s trials shortly after drinking binges” (Desecret). After such binges, the subjects were unlikely to be able to think clearly and, hence, were unable to formulate a sound decision to participate in the trials.
  • Additionally, being homeless, these subjects had a desperate need for money and shelter. These homeless individuals were paid and provided lodging by the clinical trial specialists, which may have clouded their decision-making ability.
  • Their drinking binges and desperate desire for money and shelter rendered these subjects vulnerable.

Coercion

  • In the Desecret article, one subject received $4200 and another received  approximately $2000. One subject called this “easy money.” These amounts attracted the homeless and may have also coerced them to consent to greater risks.
  • Subjects were informed that if they dropped out of a trial, they would not get all the money they were previously promised. Some recognized this as the cost of dropping out; thus, allegedly lied about the adverse effects to stay longer in the trial (Desecret, New England Journal of Medicine).

Despite the above facts, some believe that offering money is not coercive or an inappropriate influence for this population as long as researchers aren’t actually forcing the subjects into the trial (see this Virtual Mentor article). While Lilly may have not forced homeless people into unethical trials, this population still lacks legal protection and resources (see New England Journal of Medicine). Since subjects must finish trials to collect payment, their need for money overrides concern for their health. Rather than exploiting homeless alcoholics and justifying it with money, Eli Lilly should have gone to a population that can make decisions less based on desperation for cash.

Conclusion

Article 9 of the Declaration of Helsinki applies to the homeless alcoholics employed by Lilly’s 1996 phase 1 trials because homeless alcoholics are a vulnerable population and the amount of money is coercive to them. Monetary compensation does not justify using this vulnerable population.

For more information, contact the Kulkarni Law Firm.