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Death by Research

Adil ShamooAdil E. Shamoo is Professor of Medicine at the University of Maryland School of Medicine and Editor-in-Chief of the journal: Accountability in Research.

by Adil E. Shamoo

The media, legislators, and other organizations often raise concerns about human-rights violations and ethical breaches in clinical research. Such cases are legion. Human subjects are allowed to be bitten by 100 mosquitoes that could carry malaria in a study in Brazil. A French doctor performs a face transplant without the benefit of the usual research that would accompany such a high-risk procedure. An 18-year-old subject in a gene therapy trial dies, with numerous lapses in the clinical trial noted after his death.

The general public is aware of clinical research trials, but there is little awareness that the number of subjects enrolled in research is much larger than the number enrolled in clinical trials alone. While some research-related deaths reach the popular media, the actual number of deaths in research is higher. Even regulators and industry experts are not aware of the true numbers of deaths and adverse events, due to the lack of proper reporting.

The large numbers of human subjects in research are an outgrowth of the legitimate need for more and better health care throughout our ever-lengthening lifespan. No single entity keeps track of the real extent of the abuse of all human subjects engaged in research here in the United States or worldwide. I have estimated that in the US alone, there are more than twenty million subjects, half of whom represent drug trials. Worldwide, this number could exceed fifty million, with about half that number in drug studies. These staggering numbers present an awesome responsibility for our citizens and our governments alike.

The immediate ethical issue facing us is the real harm inflicted on unsuspecting subjects through a vast array of indignities, adverse events, injuries, and death. Many of those who are harmed are poor, uneducated, and politically powerless. Some are also impaired in their ability to give informed consent due to mental or cognitive disabilities, or are exposed to coercion, improper monitoring, and pervasive conflicts of interest. Moreover, the justice of the distribution of risks and benefits is questionable when research subjects are concentrated on a vulnerable segment of our society.

Bloomberg Market magazine recently published an extensive article on the unethical practices of the largest contract research organization conducting some clinical trials in Florida. Trial subjects from the Latin American illegal immigrant community were threatened with reporting of their status to the US Department of Homeland Security if they complained about the risks of the drug that they received.

That is only one example. The system of protections for human subjects worldwide is either non-existent or broken. In the US, this system has three levels: federal regulation, institutional oversight, and researchers’ ethical obligations. But there are serious shortcomings and gaps throughout the system. At the federal level, the protections apply to publicly funded research and those seeking a drug license, which probably covers 60-70% of all human subjects, although no one knows for sure. (Contrast this with the protection of animals in research, which since 1966 covers all animals, regardless of the sponsor.)

Further down the chain of supervision, research institutions are designated to “manage” their own conflicts of interests as well as those of their investigators. Yet many institutions and investigators have a financial stake in the clinical trials they are conducting. Most investigators have little or no training in ethics and regulatory compliance, for which there is no mandatory education.

Advocates in the US, such as the ten-year-old human rights organization, Citizens for Responsible Care and Research (www.circare.org), which I co-founded, have proposed a universal National Human Subjects Protection Act. However, there is no likelihood of passage anytime soon.

In the US, and most likely worldwide, opposition to serious reforms to protect human subjects in research comes from two groups: the pharmaceutical industry and universities. The objections of industry rest on the narrow issue of added financial cost. The objections of universities are more puzzling, as it is in their long-term interest to conduct research ethically.

In both cases, the effective protection of human subjects should receive much higher priority, thereby justifying the modest added expense, which probably would amount to no more than 1-2% of the overall cost of clinical studies. If such research is truly to serve the public good, the safety, health, and dignity of human subjects should not be compromised.

Copyright: Project Syndicate, 2006.


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See you share the fame Syd.

Syd, you might just get to help someone get his/her Nobel.  So if it works, make sure you get to share some of the fame! And don't blow it like my old mum. With one of the first knee joint replacements the doc was in with a chance.  Till dear old mum, (who insisted against his wishes at convalescing at home) saw a snake coming along the verandah and that was that. Snakes and mum were just not very compatible. So crutches went flying and she was up and away. I don't think that surgeon ever got over that. She wrecked the artwork just when he was upholding his great success to a group of med students from Sydney Uni. So don't be afraid Syd to acquaint the doc with all the possible complications that he may not have thought of! Cheers and best of luck.  


I hope I will be able to make a contribution on this topic in about 10 days.

Parsley , Parrots and People

It comes as no surprise that it is the pharmaceutical companies and the universities that are cited as being the greatest opponents of any reforms to protect human subjects in research. After all the drug companies are against anything that will put a dint in their profits. We all know that. Mind you they might be having second thoughts after the episode in the UK of late. And it hopefully will deter those of our young folk who have been funding some of their overseas trips this way and make them think again. Kids, is the Eiffel Tower really worth dying for? 

But I can understand the dilemma. Trialing drugs on animals, and then declaring them safe for us has proven more than a bit sus in the past. And why not? After all, we can eat parsley but it poisons a parrot I believe, and there are certainly many of examples like that. So in the end, it has to come down to just us .  So yes, there has to be much greater control over all this. Particularly to protect the vulnerable such as the mentally ill and poor and/or illegal immigrants. 

Where people are under guardianship, the decision is taken out of their hands as to the sort of medical treatment that can be imposed on them, and in the past that has led to abuse. It is still a very real worry for those with mentally disabled relatives under state guardianship in this country. And that number is likely to increase as the population ages.

As for the universities. What is their objective in opposing greater control? Well from my experience in the animal rights movement, academics like to think they are so valuable to society that no one should ever question what they do, or want to do. No, we're not looking for academic kudos. A Nobel. Who taught you to spell?  Its only noble work we do here. 

So you see, if it goes a bit pear shaped at times, they can say they were only doing their best to try and make it a better and healthier world for us all. You know, the common good.

I find particularly abhorrent those research trials that take on terminally or very ill people and some just get the placebo. If the damned thing is worth trialling in the first place, then at least give them all a fighting chance. I mean, who in their right mind would sign on for a trial if all you are going to get is a saline injection, live in hope, and then likely die anyway. No point in being the control if you are the one that ends up dead. Surely the control could be those people who never get near the trial in the first place.

Of course the research universities and other institutions don't like the world ethics very much. They arrogantly resisted broader representation in the 80s on ethics committees.  Just leave it to them to decide what is best for the beagles out the back. We won't be able to hear them howl in pain, agony or distress anyway.  And those people, they did volunteer after all.  Well, did they? How can we be so sure about that?

I put considerable effort some years back into trying to suggest ethics might be something the researchers would like to consider at a certain hallowed hall of learning where I spent four years of my life. Only to then find when it came to the crunch they would tell downright lies, to me, and to the public at large. And that about sums up why I would not put myself at their disposal for any drug trial. Never trust an academic. He probably is after that Nobel and you are just a pawn on the rocky road to fame. His fame that is.

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