The articles noted that most (75%) of US drug trials are now done by commercial firms, rather than by academic researchers. In 1991, 80% of trials were done in academia. Most of these trials have been approved by commercial, rather than academic IRBs.
This arrangement may have inherent conflicts of interest. For example, former New England Journal of Medicine Editor Marcia Angell charged, "the fundamental problem is a system in which investor-owned businesses have control over the evaluation of their own products. Oversight of clinical trials is too important to leave in the hands of drug companies and their agents."
The Bloomberg News articles suggest that there are major problems afflicting the conduct of these commercial trials. Visits by reporters to a 675-bed trial site in Miami owned by SFBC International revealed the shoddy condition of its physical plant (a bathroom with "chipped white tiles [which] reeks with urine; its floor is covered with muddy footprints and paper towels.")
The reporters suggested that trial subjects are frequently poor. They may ignore study rules to forego alcohol and narcotics. Most trial participants stated that "they barely read" informed consent documents. Reporters noted that "participants in the Miami clinical trials openly talk about how they violate SFBC rules intended to protect the integrity of the research findings."
Ken Goodman, the Director of the Bioetics Program at the University of Miami, visited the SFBC International Center, and declared
The setting is jarring. It's an eye-opener. Every one of these people should probably raise a red flag. It these human-subject recruitment mills are the norm around the country, then our system is in deep trouble.The reporters reviewed FDA records that also suggest that commercial trial centers "have used poorly trained and unlicensed clinicians." They "sometimes have incomplete or illegible records. In California and Texas, clinicians have used themselves, staff or family members as drug-trial participants."
Dr. Joanne Rhoads, who directs the FDA Division of Scientific Investigations, noted, "unfortunately, I don't think it's been recognized how important it is that people who actually conduct the trial be trained. We oftentimes see people with no qualifications whatsoever, but they'll go to a one-day training course and they call themselves a certified study coordinator."
The reporters also suggested that oversight by commercial IRBs is weak. For example, Western IRB, which is responsible for overseeing 17,000 US trials, had approved trials whose investigators ended up convicted of "lying to the FDA and endangering trial participants." Leaders of commercial IRBs have been accused of conflicts of interest. For example, Bloomberg News noted that Southern IRB, which has approved SFBC International's trials, is owned by Alison Shamblen, wife of the SFBC International vice president of clinical operations, E. Cooper Shamblen.
Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, commented,
This whole world gives me hives, this privatized review process. They've had conflicts of interest since the beginning.We previously have posted about how commercial research sponsors may try to manipulate the design, conduct, and reporting of studies to increase the likelihood of results favorable to their interests. These concerns mainly applied to studies done in academic settings.
These disturbing articles suggest that we should be even more skeptical about trials conducted by commercial firms.