MPHP 406 Tarique

Zaman
Assignment 4: Public Health Controversy Nov
17, 2010
Clinical Trials in Developing Countries

As pharmaceutical companies battle among each other for newer drugs

to beat the competition, some very challenging ethical situations are created. The
issue of clinical trials in the third world countries and the controversies related to it
are topics pertinent to this situation. With the growing competition and the difficult
economy, pharmaceutical companies have tapped the developing countries for their
huge patient load, lax monitoring agencies and corrupt officials all of which result in
cheaper avenues for drug trials. Due to illiteracy, low income and poor health care
situation in many of these targeted countries, patients consider themselves lucky,
to be able to participate in any trial which gives them a promise of relief from their
disease and suffering. The participating local physicians, mainly because of the
financial incentives, are close collaborators of the foreign companies while their
unsuspecting patients consider them to be his or her well wisher. This situation with
potential conflicting interest has the potential to irreparably damage the doctor-
patient.

Several instances of scandalous clinical trials have been uncovered in

the recent times. The 1996 trial of unregistered antibiotic, Trovan, for meningitis in
children in Nigeria by Pfizer resulted in 11 deaths and several permanent
neurological complications. The blatant disregards for consent from patients, lack
permission from the hospital, and attempts at forgery resulted in a lawsuit against
Pfizer. The case was finally settled out of court with Pfizer paying the Nigerian state
around 75 million dollars. Then there was the trial of genetically modified rice serum
trial in Lima by a California based company, Ventria Bioscience. Whether, informed
consent was taken was questionable. Because of the transgenic origin of the
supplement its trial was disapproved in the US but the company was able to go
ahead with the trial in Lima. Several complications have resulted in the 140 children
treated there. The long term effects still remain to be seen.

While the industry may have the natural inclination to blatantly

disregard ethics and human rights to play these “cheap” tricks, there is a need for a
global regulatory body to monitor clinical trials all over the world. The WHO with its
global reach has already initiated this change. The International Clinical Trials
Registry Platform was established in November 2004 with the main aim of clear
identification of trials all over the world. Its voluntary nature may be a big loophole
and the program would need more forceful implementation to ensure that trials all
over the world are run humanely.

References