----- Original Message ----- > > Copyright � 2000 The International Herald Tribune | www.iht.com > > Drug Companies' Tests in Poor Countries Raise Ethical > Questions > Joe Stephens Washington Post Service > Monday, December 18, 2000 > > Some Risky Experiments Are Done With Little Oversight > > KANO, Nigeria By the time word of the little girl's death reached the United > States, her name had been replaced by numerals: No. 6587-0069. > > She was 10 years old and a scant 41 pounds (18.6 kilograms). She lived in > Nigeria, and in April 1996 she ached from meningitis. > > An epidemic raged and scores lay dying in this frenetic city of amber dust. > Somehow the girl found a refuge: a medical camp where foreign doctors had > arrived to dispense expensive medicines for free. > > Behind a gate besieged by suffering crowds stood two very different clinics. A > humanitarian charity, Medecins Sans Frontieres, had erected a treatment > center solely in an effort to save lives. Researchers for Pfizer Inc., a huge > American drug company, had set up a second center. They were using > Nigeria's meningitis epidemic to conduct experiments on children with what > Pfizer believed was a promising new antibiotic - a drug not yet approved in the > United States. > > The experimental drug was a potential blockbuster: Wall Street analysts said > Pfizer might reap $1 billion a year if Trovan, as it was known, won approval for > all its potential uses. Pfizer also wanted to test the drug for use against > meningitis, including an epidemic strain. The company could not find enough > patients in the United States, so its researchers had come to Kano, among the > dying. > > Doctors working with Pfizer drew spinal fluid from the girl, gauged her > symptoms and logged her as Patient No. 0069 at Testing Site No. 6587 in > Experiment No. 154-149. They gave her 56 milligrams of Trovan. > > A day later, the girl's strength was evaporat- ing, Pfizer records show, and one > of her eyes froze in place. On the third day, she died. > > Pfizer records are explicit. Action taken: "Dose continued unchanged." > Outcome: "Death." > > Nobody can know for certain if the girl would have lived had she been taken off > experimental Trovan; perhaps she was beyond all hope. Yet the circumstances > of her death - while taking an unapproved drug, with alternative treatments at > hand, in a hurriedly established private-sector experiment - suggest much > larger problems. > > A Washington Post investigation into corporate drug experiments in Africa, > Asia, Eastern Europe and Latin America reveals a booming, poorly regulated > testing system that is dominated by private interests and that far too often > betrays its promises to patients and consumers. > > Experiments involving risky drugs proceed with little independent oversight. > Impoverished, poorly educated patients are sometimes tested without > understanding that they are guinea pigs. And pledges of quality medical care > sometimes prove fatally hollow, The Post found. > > Drugmakers hop borders with scant government review. Largely uninspected > by the U.S. Food and Drug Administration - which has limited authority and few > resources to police experiments overseas - U.S.-based drug companies are > paying doctors to test thousands of human subjects in the Third World and > Eastern Europe. > > The companies use the tests to produce new products and new revenue > streams, but they are also responding to pressure from regulators, Congress > and lobbyists for disease victims to develop new medicines quickly. By > providing huge pools of human subjects, foreign trials help speed new drugs to > the marketplace - where they will be sold mainly to patients in wealthy > countries. > > The Food and Drug Administration requires that patients in such tests, no > matter where they live, consent fully to the experiments if the results are to be > used to win marketing approval in the United States. And, in fact, many tests > conducted in the Third World are conducted carefully and serve to expedite the > creation of lifesaving drugs. But The Post's investigation found that in other > instances the rules are poorly enforced or ignored. > > The 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. > > A Nigerian physician who said he was present during the Kano experiment, for > instance, felt it was "a bad thing," but he did not object because Pfizer's test > appeared to have government backing. > > "I could not protest," said the physician, 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." > > Industry guidelines for conducting meningitis experiments never envisioned > testing an antibiotic amid a terrible epidemic in a squalid, short-staffed medical > camp lacking basic equipment. > > Dr. George McCracken, a Texas pediatrician and leading meningitis specialist > who co-authored the guidelines, said he was surprised that Pfizer's > researchers had attempted such a venture. "I just wouldn't do a study that way > myself," he said. "I know they wanted to get the data. They wanted to go fast. > They wanted to move ahead. I'm not sure they made a smart decision." > > Among the 200 stricken children enrolled in its experiment, 11 died and others > suffered meningitis-related symptoms such as deafness, lameness, blindness, > seizures and, in one case, an inability to walk or talk, company records show. > > Pfizer said its goal was to study the safety and effectiveness of its antibiotic > while simultaneously pioneering a breakthrough treatment for the Third World. > The company contends that its practices were validated - especially given the > horrendous conditions it found - by the number of children who showed > improvement and by a fatality rate of about 6 percent, which compares > favorably with those reported for bacterial meningitis victims treated at U.S. > hospitals. The Trovan experiment, a company spokeswoman said, was > approved by a Nigerian ethics board and "was sound from medical, scientific, > regulatory and ethical standpoints." > > Pfizer researchers prepared the study over six weeks, instead of the year or > longer common in the United States. And while American meningitis patients > generally receive fast-acting intravenous medicines, the researchers gave > most of the Nigerian subjects an oral form of Trovan that the company said had > never been tested in children. > > Ten doctors interviewed about Patient 0069's death - including pediatricians, > meningitis specialists and physicians who have practiced in developing > countries - said they were troubled by her case. Their questions focused in > part on whether doctors left her on the test drug for too long as her health > declined. Generally, if subjects are not responding to an experimental > treatment, they are removed from the test and given proven medicines. > > Industry guidelines governing meningitis experiments urge that researchers > conduct a second spinal tap a day or so after treatment begins, to see if the > medication is working. Pfizer researchers chose to make such exams optional > in Nigeria, and Pfizer said they did not perform one on Patient 0069, leaving > her on the experimental drug until her death. > > "It could be considered murder," said Evariste Lodi, the Medecins Sans > Frontieres physician who led the charity's efforts against meningitis in Kano, > after he reviewed a Pfizer description of Patient 0069's death. Added Agwu > Urondu, a Nigerian physician still working in the city: "The patient died because > the doctor refused to help." > > In a written statement, a Pfizer spokeswoman said a death such as Patient > 0069's could occur during treatment with any antibiotic and that researchers > had no reason to suspect the experimental medicine was not working. > > Abdulhamid Isa Dutse, a Nigerian doctor hired by Pfizer to run the experiment, > agreed that physicians should alter the medication of a patient who is not > improving. "To be very, very honest, in retrospect, maybe we should have done > something about that," he said of the girl. > > Dr. Yola and others who battled the epidemic said patients did not understand > they had been in an 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, saying that local nurses explained the research to families, > even though the company has no signed consent forms to prove it. > > Although Pfizer eventually won approval to sell the drug to adults in the United > States, in the end its push to bring Trovan to market turned out badly. > Authorities never approved marketing the antibiotic for use by children in the > United States or Nigeria. U.S. regulators discovered dozens of discrepancies in > the Kano test results. Last year, they advised doctors to restrict Trovan's use > in adults because patients had suffered liver damage and death. European > regulators suspended sales altogether. > > Pfizer's Nigerian clinic opened and closed in a relative eye blink: About three > weeks after the company's team roared in with a chartered DC-9, the team > roared out. Pfizer's doctors returned once to examine the patients but did not > track their long-term recovery. > > "If I had the power," said Dr. Lodi, who watched the experiment unfold from > across the compound, "I would take away their medical licenses." > > Copyright � 2000 The International Herald Tribune > > > > > > > _____________________________________________________________ > Get free, private email ---> http://www.serbiancafe.com > _______________________________________________ Crashlist resources: http://website.lineone.net/~resource_base To change your options or unsubscribe go to: http://lists.wwpublish.com/mailman/listinfo/crashlist
