One man has been pronounced brain dead and another six are in a critical condition after a stage-one pain-relief drug trial was carried out in France.
The men were among 90 participants in the trial of an endocannabinoid inhibitor produced by the Portuguese pharmaceutical firm Bial.
The drug, a so-called FAAH inhibitor, was intended to reduce pain in the patients. The affected patients, however, have experienced serious adverse side effects and some face permanent handicaps.
The brain dead patient was admitted hospital in Rennes on Monday. Other patients went in on Wednesday and Thursday. The trial, which has only been running for a week, was cancelled after the incidents were reported. All patients taking part in the trial have been called back for medical examination.
French officials expressed their concern about the incident, but argued that the trial was carried out in accord with existing regulations.
In 2006 a leukaemia drug trial in the UK at Northwick Park Hospital resulted in the hospitalisation of six men, some of whom now have permanent disabilities.
Dr Ben Whalley, a neuropharmacology professor at Britain’s University of Reading, said standardised regulations for clinical trials were “largely the same” throughout Europe. “However, like any safeguard, these minimise risk rather than abolish it,” Whalley said. “There is an inherent risk in exposing people to any new compound.”
Dr Anna Smajdor, lecturer and researcher in biomedical ethics, University of East Anglia’s Norwich Medical School, is awaiting more information:
“Phase one trials often involve young participants who take part in return for payment. The nature of clinical research means that every so often, people will be seriously harmed or even killed in the process of research, there is no way round this.
“The question in this case is whether, as in Northwick Park, there were any failures of protocol that meant participants suffered more damage than necessary – in Northwick Park, they administered the drug to all volunteers at once instead of staggering it so they could avoid a bad reaction affecting all of the participants.”
BioEdge: Is US medicine becoming an assembly line?
Two physicians from Beth Israel Deaconess Medical Center and Harvard Medical School in Boston complain in the latest New England Journal of Medicine that “Taylorism has begun permeating the culture of medicine” with the implementation of electronic health records. Here are excerpts from their attack on what they believe to be a drive to treat patients like cars on an assembly line:
Physicians sense that the clock is always ticking, and patients are feeling the effect. One of our patients recently told us that when she came in for a yearly “wellness visit,” she had jotted down a few questions so she wouldn’t forget to ask them. She was upset and frustrated when she didn’t get the chance: her physician told her there was no time for her questions because a standardized list had to be addressed — she’d need to schedule a separate visit to discuss her concerns.
We believe that the standardization integral to Taylorism and the Toyota manufacturing process cannot be applied to many vital aspects of medicine. If patients were cars, we would all be used cars of different years and models, with different and often multiple problems, many of which had previously been repaired by various mechanics. Moreover, those cars would all communicate in different languages and express individual preferences regarding when, how, and even whether they wanted to be fixed. The inescapable truth of medicine is that patients are genetically, physiologically, psychologically, and culturally diverse. It’s no wonder that experts disagree about the best ways to diagnose and treat many medical conditions, including hypertension, hyperlipidemia, and cancer, among others.
To be sure, certain aspects of medicine have benefited from Taylor’s principles. Strict adherence to standardized protocols has reduced hospital-acquired infections, and timely care of patients with stroke or myocardial infarction has saved lives. It may be possible to find one best way in such areas. But this aim cannot be generalized to all of medicine, least of all to such cognitive tasks as eliciting an accurate history, synthesizing clinical and laboratory data to make a diagnosis, and weighing the risks and benefits of a given treatment for an individual patient. Good thinking takes time, and the time pressure of Taylorism creates a fertile field for the sorts of cognitive errors that result in medical mistakes. Moreover, rushed clinicians are likely to take actions that ignore patients’ preferences….
Medical Taylorism began with good intentions — to improve patient safety and care. But we think it has gone too far. To continue to train excellent physicians and give patients the care they want and deserve, we must reject its blanket application. That we’re beginning to do so is shown, for example, by a bill before Congress that would delay implementation of the Meaningful Use Stage 3 criteria for information-technology use in health care. We need to recognize where efficiency and standardization efforts are appropriate and where they are not. Good medical care takes time, and there is no one best way to treat many disorders. When it comes to medicine, Taylor was wrong: “man” must be first, not the system
In his State of the Union address President Obama announced a cancer moonshot: an ambitious plan to cure cancer. "The same kind of concentrated effort that split the atom and took man to the moon should be turned toward conquering this dread disease," he said.
Oops. He didn’t say that. Richard Nixon did in his 1971 State of the Union address. “We want to be the first generation that finally wins the war on cancer,” then-Vice President Al Gore said in 1998. “For the first time, the enemy is outmatched.”
It’s not just the politicians who know how to cure cancer. Scientists make big promises as well. In 2005 the Director at the National Cancer Institute, Andrew von Eschenbach, said “Our plan is to eliminate the suffering and death that result from this process that we understand as cancer, and we are committed to a goal of doing so as early as 2015.”
That commitment was made only ten years ago and cancer is still the second leading cause of death in the United States.
It’s great to feel optimistic, but one has the feeling that promises like these are made to distract voters from other issues. “It’s a bit utopian at this point,” agreed Barrie Bode, a professor at Northern Illinois University and a 20-year cancer researcher, told MarketWatch. “It’s like saying we need to fix the economy once and for all. Right, like that’s going to happen,” he said.
However, if you are looking for a job in cancer research, now looks like a very good time.
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