It so happened that Russian doctor Karlov was trying to find patients for another clinical trial for an experimental drug, and Ershov fit the requirements to enter the study. "They told me the treatment was safe," says Ershov. "I trust my doctor completely." Like 90% of Karlov's other clinical-trial patients, he immediately signed the consent form (Lustgarten, p. 1). Russia is one of those countries that suffers from high costs and low standards of medicine as well as lack of doctors.
Outsourcing of medical trials is on the rise. As many as 40% of all drug testing is going to "emerging markets" and this number is rising. Vioxx and Zocor, created by Merck, tested in Russia as well as a few other developing nations, and many of Pfizer's drugs that earned them billions of dollars (AP, p. 1).
These experiments "raise questions about corporate ethics and profits on a frontier of globalization where drug companies wield enormous influence, and where doctors paid by U.S.-based corporations sometimes perform experiments on ill-informed patients in authoritarian societies" (Stephens, p. 1). A Nigerian physician who was present during the Kano experiment felt it was "a bad thing," but because Pfizer's test appeared to be backed by the U.S. And his own government, he did not object. "I could not protest," said Amir Imam Yola. "The system you have in America and the system we have here, there is a wide gap. Freedom of speech is still not here" (Stephens).At that time a military junta ran Nigeria's government, with a record of corruption and of being one of the world's worst human rights violators.
While 11 of the 200 stricken children enrolled in Pfizer's experiment died, others suffered an inability to walk or talk, deafness, blindness, lameness, seizures, and disorientation, which are meningitis-related symptoms, Pfizer records show (Stephens, p. 1). This analysis will look at the operational, strategic and ethical ramifications of these results.
Pfizer said it wanted to study the effectiveness and safety of the antibiotic while providing a breakthrough treatment for this suffering Third World country. It validated its practices, given the horrendous conditions found, by showing how many children's health improved while maintaining a fatality rate of 6%, comparing favorably to bacterial meningitis victims treated by hospitals in the U.S. A company spokeswoman said the Trovan experiment was approved by the Nigerian ethics board to be "sound from medical, scientific, regulatory and ethical standpoints" (Stephens, p. 1). However, it was later revealed that there was no Nigerian ethics board. In addition, the samples were not tested correctly, resulting in study results so tainted that the results wee not accepted (Spar, p. 3).
As far as operational analysis, it took Pfizer researchers just over six weeks to prepare the study, instead of a year or so, as is common in the U.S. And here meningitis patients usually receive intravenous medicines, while the researchers gave the Nigerian subjects oral Trovan, which had never been tested (Stephens, p. 1).
During the trial, the ten doctors, including physicians practicing medicine in developing countries, meningitis specialists and pediatricians, were interviewed about Patient 0069's death and were troubled by her case. They focused on whether doctors "left the child on the drug too long while her health declined." Normally, if a human subject is not responding to an experimental drug, they are given already proven medication and are removed from the test. In addition, guidelines urge researchers to conduct a second spinal a day or so following commencement of treatment to...
Pfizer researchers said they did not perform a second spinal tap on Patient 0069 and left her on the drug until she died. Pfizer chose to make such spinal exams optional in Nigeria. A Nigerian physician still working in Kano said "The patient died because [the doctor] refused to help." (Stephens, p. 2).
Pfizer spokeswoman said Patient 0069 could have died with treatment by any antibiotic and their researchers did not suspect Trovan was not working (Stephens, p. 1). A Nigerian doctor hired by Pfizer to run the experiment, Abdulhamid Isa Dutse, said physicians should change medication of any patient who is not improving on the current one. "To be very, very honest, in retrospect, maybe we should have done something about that," he said of the girl. Dutse has since been removed from his post, (Stephens, p. 1).
Patients did not understand they were part of an experiment, said the doctors who had been involved in the experiment. "The patients did not know if it was research or not," agreed a Nigerian laboratory technician who took part. "They just knew they were sick." Pfizer disputes that, and said local nurses explained to families who participated, but did not have them sign consent forms (Stephens, p. 1).
In the United States Pfizer got approval to sell Trovan to adults, but bringing it to market turned out badly. It was never approved for use by children in the U.S. Or in Nigeria. Regulators found dozens of discrepancies in Kano experimental results. They advised doctors that use in adults might cause liver damage and death. European regulators forbid sales altogether (Stephens, p. 1).
As far as strategic critiquing, Pfizer's Nigerian clinic opened and closed in a relative short time: Three weeks after they arrived in a chartered plane, the team flew out again. The doctors involved returned once more to examine their patients but did not follow up for long-term recovery. "If I had the power," said a doctor who watched the experiment across the compound, Dr. Lodi of Doctors Without Borders, "I would take away their medical licenses." (Stephens, p. 1)
For Pfizer, the timing was oddly fortuitous. The New York-based, then-$11 billion-a-year corporation was pushing to submit Trovan for FDA approval. A bacteria fighter, Trovan had shown promise against a broad range of infections - sinusitis, bronchitis, gonorrhea and pneumonia. Thousands of patients had enrolled in international drug studies in the company's biggest testing program ever. Wall Street analysts predicted that Trovan could be one of the most financially successful new drugs of its kind in years. There were worries, however, about possible side effects in children. Trovan belonged to the quinolone class of antibiotics, and quinolones had caused joint damage in experiments on young rabbits and puppies (Stephens, p. 2).
We had to move quickly," explained Pfizer's Betsy Raymond. "You would not be able to find those numbers of children with spinal meningitis in the U.S." (Stephens, p. 2)
Hopkins who then headed Trovan development, pushed for the experiment in Africa, saying its success would make all their drugs look good (Stephens). So Pfizer authorized the venture to win FDA approval for Trovan use in meningitis epidemics. Hopkins says that the designation proved the experiment philanthropic rather than a cheap, unethical way to get drugs approved for use on American children (Stephens, p. 1).
But of course Pfizer was hoping to gain from this venture. Even though the drug was not approved by the FDA, had never been used with an oral administration, and the experiment was conducted under the worst conditions by unethical supervisors, under unsanitary and haphazard conditions, with faulty record-keeping, Pfizer still hoped to gain a useful drug which would be in demand. A specialist, Creighton University pediatrics department Chairman Stephen Chartrand, said use of an oral drug under those circumstances would be "unconscionable." (Stephens, p. 1)
Though most of the trials in Third World countries and Russia are conducted without troubling issues, there are enough instances of breakdowns in the scientific process and ethical abuse to create a concern. Other charges concerning other trials which have endangered unwitting patients or which were followed through lacking proper ethical review have occurred over the years. (Lustgarten, p. 1)
Some of the materials we needed to establish that Pfizer was fraudulent only came out after we filed the suit," said Irukera of the trial now going on in Nigeria. An earlier suit only levied a lesser charge of "fraudulent representation." (AP, p. 1)
We stand by our previous statements on this issue," Pfizer said. "The Trovan study was approved in advance by the federal government of Nigeria, it was conducted in an ethical and appropriate manner, and it helped save lives. To our knowledge there is no additional information in the case. Any purported new facts more than 11 years after the study was conducted are simply rehashed allegations dressed up differently, and equally without merit." (AP, p. 1) This statement only underlines the unethical basis upon which Pfizer stands, as the fact that its "approval" by the Nigerian board of ethics was found to be fabricated.
While the authorities in the state and city of Kano blame the Pfizer controversy for creating suspicion of government public health policies, Islamic leaders in the mainly Muslim city of Kano have pointed at the Pfizer controversy as sure evidence of an overall U.S.-led conspiracy. (AP, p. 1).
Recommendations for better handling of this situation follow.
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