Pfizer to pay $75mil for unethical Nigeria drug trial
The Independent’s Daniel Howden reports that, for about $75 million, Pfizer has settled cases related to a disastrous unlicensed medical trial in Nigeria. The trial involved the experimental broad-spectrum antibiotic Trovan trial on 100 Nigerian children trapped in the midst of a devastating outbreak. Pfizer called the trial a humanitarian mission but did not get the consent of parents or the Nigerian government.
Howden tells the story of the trial itself, which Pfizer conducted near a legitimate Doctors Without Borders clinic:
From the crowd that had gathered at the Kano Infectious Diseases Hospital, 200 sick children were picked. Half were given doses of the experimental Pfizer drug called Trovan and the others were treated with a proven antibiotic from a rival company.
Eleven of the children died and many more, it is alleged, later suffered serious side-effects ranging from organ failure to brain damage.
Pfizer’s defense, meanwhile, was almost as sketchy as the trial itself:
Pfizer has denied this and says consent had been given by the Nigerian state and the families of those treated. It produced a letter of permission from a Kano ethics committee. The letter turned out to have been backdated and the committee set up a year after the original medical trial.
Finally, Howden notes that the legal wrangling isn’t over yet, thanks to a court ruling dictating that Pfizer could stand trial in the United States as well.
Foundation lived by big pharma, now dies by big pharma
Filed under: Hot Health Headline, Pharmaceuticals, Studies
Kris Hundley of the St. Petersburg Times reports that the Ischemia Research and Education Foundation, which maintained a massive patient care database intended to prevent heart attacks and strokes during and after surgery, is teetering on the brink of financial collapse. While his foundation relied on drug company grants for much of its funding, “monumentally stubborn and notoriously prickly” founder and leader Dr. Dennis Mangano insisted on IREF’s right to publish any and all of its findings, a move he said maintained its independence.
Despite its ties to pharmaceutical companies, Mangano’s foundation made some impressive discoveries, Hundley lists a few highlights:
He found that taking low-cost aspirin after bypass surgery reduces the risk of heart attack. He sounded the alarm about the deadly risks of using Bayer’s drug Trasylol to control bleeding during bypass surgery — nearly two years before the FDA suspended marketing of the drug.
And he warned that Pfizer’s painkiller, Bextra, raised the risk of heart attack and stroke in bypass patients. Bextra was pulled from the market in 2005.
The relationship between pharmaceutical companies and IREF seems to have always been an uneasy one. IREF’s recent troubles began when a rogue employee shared data with Pfizer for which the drug giant would otherwise have had to pay $15 million to $20 million. Mangano refused to settle with the company, instead taking it to court and winning damages totaling almost $60 million.
Now, a judge’s ruling has given Pfizer a second chance and Mangano says he can’t afford to match Pfizer’s resources in the courtroom a second time. He says his suit against Pfizer has made him a “persona non grata” in the pharmaceutical industry and thus cut off what used to be the foundation’s primary source of funding. IREF has gone from 80 employees to just three, and is bleeding money at an unsustainable rate.
Investigation of drug-trial suicide earns award
For a story on ethical issues in a drug trial that may have contributed to a patient’s suicide, St. Paul Pioneer Press reporters Jeremy Olson and Paul Tosto earned the Minnesota Journalism Center’s Frank Premack Public Affairs Journalism Award for excellence in investigative or analytical reporting about public affairs in the Twin Cities metro area.
Through the eyes of grieving mother Mary Weiss, Tosto and Olson followed Dan Markingson’s schizophrenia diagnosis, his participation in a University of Minnesota clinical trial for AstraZeneca’s Seroquel and his eventual suicide in 2004. Markingson was diagnosed, treated and enrolled in the study by Dr. Stephen Olson, who also happened to be looking for hard-to-find patients with Markingson’s symptoms for the psychiatric drug trial he was running.
From the judges:
In this piece, Olson and Tosto reported for the first time on schizophrenia patient Dan Markingson’s death and the resulting lawsuit and probes. In the process, they pulled back the curtain on the rarely viewed world of industry-funded clinical research and the financial incentives that can compromise a doctor’s decision-making.
Premack judges in this category said: “Through the eyes of one patient, this story shed considerable light on the complicated and competing interests between the development and path to market of new drugs, funding needs of the University and the integrity of medical research. The judges are hopeful that the new ethics task force implemented at the U of M is resulting in changes in conflict of interest policies.”
Olson and Tosto said Markingson’s death also raised “questions about why the Institutional Review Board, the internal group charged with protecting people in university studies, didn’t intervene.” The reporters also used the the $782,000 paid by drug companies to the two psychiatrists overseeing Markingson’s trial (including $261,000 from AstraZeneca) to highlight national criticism of the conflict of interest inherent in pharmaceutical-company funding of clinical trials and questioned whether study staff would be willing to let the public know if something untoward occurred during a trial.
“Physicians face a difficult choice,” testified Dr. Greg Rosenthal, an Ohio eye specialist. “One path is to go along. With drug company money, you can increase your income, prestige, build your practice or fund a department, research or professorships. The middle ground is to simply look away. The hard choice is to fight back.”
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