Originally Posted by FloorJack
Doing a clinical trial in the US is difficult and expensive. I wouldn't say "they're still doing all kinds of things behind the scenes still in the US that never get 'inspected'".
I actually do clinical trials for devices and can tell you the companies I work with have take their trials to other countries because it's cheaper. They can do the same trial with same level of ethics and respect for the participant for far less money overseas.
Well you can't argue there isn't good cause for being suspicious that there may be.
I'm sure there's a mixed bag of companies out there, some very ethical and some less so-
"Pfizer’s Trovan clinical trial-
In early 1996, an epidemic of bacterial meningitis broke out in the state of Kano, Nigeria. Bacterial meningitis is an infection of the meninges (the membranes around the central nervous system) that is diagnosed by the presence of infectious material and other changes within the cerebrospinal fluid, and if not properly treated, can result in hearing loss, brain damage, or death. However, with early diagnosis and treatment, the risk of death is less than 15%. Doctors Without Borders/Médecins Sans Frontières (MSF), a nonprofit humanitarian organization, arrived in Kano shortly after the initial outbreak to provide humanitarian and medical aid. The organization began to treat the victims of the outbreak with the intravenous form of chloramphenicol, a WHO-endorsed generic antibiotic for bacterial meningitis in low-income countries.
Within six weeks of hearing about the epidemic, Pfizer drew up a plan to test an oral form of the antibiotic trovafloxacin, trade-named Trovan, on the children in the Kano clinic. If the oral form of Trovan could be shown to be as effective as the intravenous antibiotics were for children, it would be a tremendous “breakthrough in battling epidemics” worldwide.
Children could simply swallow a pill rather than receive injections that increase the risk of blood-borne diseases, such as HIV and hepatitis. Further, a pill would remove the need for skilled healthcare workers to administer the treatment. Wall Street analysts predicted that, if the Food and Drug Administration (FDA) approved the oral form, it would be a US$1 billion blockbuster drug.
On April 3, 1996, Pfizer’s team of physicians arrived in Nigeria to conduct clinical trials on children infected with bacterial meningitis. Nigerian officials authorized Pfizer to conduct the testing in two wards of the Infectious Disease Hospital. Pfizer selected two hundred sick children from the many children who were awaiting treatment, divided the children into two groups, and treated one group with Trovan. The other group of children was “purposefully ‘low-dosed’” with ceftriaxone, an FDA-approved drug. According to Pfizer protocol, the children were supposed to have their blood tested at the point when they were diagnosed and entered into the trial and again after five days of treatment. If a child was not responding well to Trovan, protocol required switching the child’s medication to ceftriaxone. According to an internal Pfizer document, however, this plan for follow-up blood testing was generally abandoned “due to the shortage of medical staff.”
As a result, Pfizer did not analyze the children’s blood samples and therefore could not determine those cases in which the medication was not an effective treatment until the child manifested visible and often permanent impairment.
Pfizer protocol required injecting ceftriaxone into the subject’s vein or muscle. Again, due to the shortage of skilled workers, the drug was usually injected into the child’s buttocks or thighs (i.e., muscle injections) to save staff time and trouble. The shots were severely painful, leading to reports of “great fear and sometimes dangerous struggles with children.”
To lessen the pain after initial injections, the report indicated, researchers reduced the amount of antibiotic given to children who were improving to one-third of the recommended amount. Pfizer maintained that the reduced dose was more than sufficient. The drug’s manufacturer, Hoffmann-La Roche, however, reported that the reductions could have lowered the drug’s efficacy and skewed any comparison to Trovan. There is also evidence that Pfizer failed to switch to standard therapy the children who were receiving Trovan but not showing any signs of improvement. This breach in standard protocol allegedly led to severe brain damage or death for several children.
The requirement of informed consent from either children or their guardians is part of Pfizer’s protocol and is also found clearly stated in a number of related international documents; these include the international human subject protections contained in the Nuremberg Code, the Helsinki Declaration, Article 7 of the International Convent on Civil and Political Rights (ICCPR), guidelines by the Council for International Organization of Medical Services (CIOMS), and certain WHO guidelines.
However, Pfizer could not produce any evidence that its staff had informed the children’s parents that the proposed treatment was experimental, that they could refuse it, that serious risks were involved, or that other organizations at the same site offered more conventional treatments for free. In addition, Pfizer failed to follow its own protocol that required staff to offer or read documents to participants in either English or Hausa to facilitate their informed consent. When interviewed later, many of the patients and their parents claimed that they did not know they were participating in an experimental drug trial. Pfizer described the lapse as a procedural error, but stressed in a written statement that “verbal consent was obtained.”
After spending two weeks in the Kano camp conducting tests, Pfizer withdrew its personnel without administering any post-trial care. Five children who received Trovan and six children to whom Pfizer had administered a low dose of Ceftriaxone died. Others suffered blindness, deafness, and paralysis. While US medical guidelines recommend that meningitis experiments include long-term follow-up, Pfizer’s clinical trial protocol made no mention of the need for long-term monitoring.
In 2001, the families of the dead and injured children filed suit against Pfizer under the Alien Tort Statute (ATS) for violating a norm of “customary international law prohibiting medical experimentation on non-consenting human subjects.”
Specifically, Pfizer was sued for violating the principle of informed consent, refusing to provide the best treatment available when it supplied low doses of the drug approved by the FDA and when it failed to monitor the progress of the children in the study, and for its decision to conduct a trial using a medication that is known to cause liver damage in children. What the families soon learned however — and arguably what Pfizer had known all along — is that neither international nor US law provided redress against American companies for human rights violations committed abroad."