Billing the Victims of Unethical Medical Research

Carl Elliott, MD, PhD
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Imagine for a moment that you are seriously injured in a medical research study and require expensive medical care.   Imagine further that the study in which you are injured is scientifically worthless, deceptive and exploitative – sort of like the Tuskegee syphilis study, for example.  Who ought to be responsible for paying for your medical care?

In the United States, the answer is: You are.  There is no legal obligation for a research sponsor to pay for your medical care, even if the sponsor is directly responsible for your injury.  In the United States, only 16 percent of academic health centers make it a policy to pay for the care of injured subjects, and none of them compensate subjects for lost wages or suffering.  As a consequence, the risks of participating in medical research in America do not merely include illness, injury and death.  They also include financial ruin.

Last week I published an article about the injustice of this policy in the New England Journal of Medicine. But the best scholarship on the topic comes from Elizabeth Pike, a research analyst with the Presidential Commission for the Study of Bioethical Issues.  She graciously consented to an interview.

I think a lot of outsiders are shocked to find out that if research subjects are injured in a clinical trial, they are usually responsible for paying their own medical bills.  In this, as in many other things, American medicine stands apart from the rest of the developed world.  You make it clear in your article that you believe this is unjust, but I wonder: Can you hazard any guesses as to why the injustice has endured for so long?

I think one reason the injustice has endured for so long is that we lack empirical data about the scope of the problem. We don’t know how many people are injured as a result of their participation in research. We don’t know whether serious research injuries are routine or rare. A number of national commissions have considered the issue of compensating injured research subjects, and have concluded that they cannot take concrete steps forward until the scope of the problem is better understood.

Why is the scope of the problem so important?  I’d have thought that even if injuries are rare, it is still unjust to force the injured subject to pay for his or her own medical care.

I agree that forcing injured research subjects to pay out-of-pocket for medical care necessitated by research is unjust. But people are hesitant to implement a solution they fear may be expensive to something they worry may not actually be a problem. Many people also think—incorrectly, as it turns out—that injured research subjects can just bring a lawsuit to receive compensation. As my article “Recovering from Research” points out, this is just not true. Without hard data showing that research subjects do get injured and are forced to pay for the resulting medical care themselves,  implementation of a comprehensive solution will likely remain on the back burner.

Every other developed country in the world has taken measures to fix the injustice anyway.  We’re the exception.  What’s different about us?

One reason may be that in countries with universal health insurance, injured research subjects likely have their medical bills covered; any obligation to provide compensation for research-related injuries may end up being relatively inexpensive. In the United States, some research subjects are uninsured and medical care for serious injuries can be quite expensive. This may mean that, depending on how implemented, requiring no-fault compensation for research injuries could be costlier in the United States. The United States has, however, implemented several successful and cost-effective no-fault compensation systems, including workers’ compensation and car insurance, so fears of an expensive no-fault compensation system may be overblown. We should also recognize that requiring compensation does not add new costs to research; rather, it shifts costs that are already being borne by injured research subjects or their insurers.

You recommend a no-fault compensation system as a solution.  Can you say a few words about why you think that’s the best option?

The alternative to a no-fault compensation system is continued reliance on the legal system. My article “Recovering from Research” details the many ways the legal system—and the tort system, in particular—falls short. International research subjects and subjects injured in federally conducted research are essentially unable to receive compensation through the courts. All other research subjects face serious challenges, including difficulty proving causation and the chance that a signed informed consent document may be viewed as assuming the risks of research. Given that the alternative to a no-fault compensation system is continued reliance on a legal system that denies most research subjects access to compensation, no-fault compensation seems like the better choice.

Once you decide to implement no-fault compensation, there are several possibilities for no-fault compensation systems. In the United States, the two leading possibilities are an insurance/self-insurance requirement comparable to our workers’ compensation system and a no-fault compensation court modeled on the Vaccine Court.

An insurance/self-insurance requirement has several advantages that, to my mind, make it the best solution for compensating injured research subjects. First, an insurance/self-insurance requirement could be implemented with minimal centralized bureaucracy. Second, depending on how implemented, an insurance/self-insurance requirement could retain economic incentives for sponsors to minimize risks to subjects. Third, and perhaps most importantly, an insurance/self-insurance requirement would bring our laws into accord with the laws of much of the rest of the world. Many of the countries most involved with research—including 31 European Union countries, Brazil, China, India, and South Africa—have implemented an insurance/self-insurance requirement. Given that so much research is conducted multinationally, bringing U.S. law into closer conformity with the laws of other countries could benefit researchers who conduct multinational research.

Unlike an insurance/self-insurance requirement, the Vaccine Court model is incompatible with no-fault compensation systems around the world, so could cause problems for researchers who conduct multinational research. A Vaccine Court model also requires a centralized bureaucracy, and may implement a risk-pooling system that reduces researchers’ economic incentives to minimize risks to research subjects.

Acknowledgement: This interview was first posted on the Chronicle of Higher Education Brainstorm blog.

9 COMMENTS

  1. You think that’s bad? Think about the people who are forced to pay for involuntary treatment. I think there used to be someone who commented here who had a story about that. Imagine being dragged out of your home by the police and taken to a hospitals psych unit, then imagine being forced to take powerful neuroleptic drugs either by force or coercion, then imagine either suffering serious adverse events or not but most importantly imagine that two weeks after you’re released you get a ten-to-twenty thousand dollar medical bill. That’s tremendously unjust, but then again so is the forced “treatment” in the first place.

    • Ten to twenty thousand dollar bill? I stayed two and a half months in a state hospital. My bill for that stay totaled $364,000! I have no insurance. They want me to give them $4,000, which I still can’t pay at this point. I guess $4,000 is better than $20,000d and it’s one heck of a lot better than $364,000! I still can’t believe that my care cost that much. I should have been in aluxury hotel with servants and a limo for that kind of money!

      • I know, it’s ridiculous. It’s a giant scam and yet if you try to expose and argue against it to the general public you’ll get accused of not caring about mentally ill people by the liberals and progressive types or get a “hell ya, kick them out on their ass!” by libertarian conservative types. Everyone chooses to stay blind to the scam. Too many people watch shows like House and think that mental hospitals are places of love and care where trained psychotherapists get to the root of your deepest memory and bring greater meaning to your life. Psych units will charge UPWARDS of 1,000 dollars a day to just drug someone, feed them three times, sit them in front of a T.V., have someone run a few pointless group sessions (never even for therapy anymore since confidentially is too important) and then put them back to bed. This same care, THIS SAME EXACT CARE, could be offered at less than $100 dollars a day if it weren’t for psychiatry and it’s scam.

        • dYou’ve hit the proberbial nail directly on it’s head! The groups I was assigned to go to were absolutely the most ludicrous things I’ve ever attended in my life. I am a former high school steacher and a retired certified hospital chaplain with clinical training in both medical and psychiatric hospitals. I kow what groups are supposed to be like. I refused to go to them and when my psychiatrist finally got around to asking me why I wasn’t attending them I told him it was because I didn’t waste my time going to things that I could do a better job of running. I go to groups to learn about things, not to be bored to absolute tears. So you’re right; what they charged me $364,000 for was three meals and a bed, plus the toxic drugs they wanted to push down my throat. What a laugh. The eight peer respite houses in the United States can provide great care (without durgs and coercion) for about $250/day as opposed to $1,000+/day at the so-called psychiatric hospitals. What is wrong with this picture. thanks for responding to my post. You helped me feel better about my decision not to pay the $4,000 even.

      • Oh and don’t ever pay a penny of that bill. I’m assuming you’re from the U.S. and there are no laws here that would punish you for not paying. If debt collectors have told you otherwise then they are simply lying. The most they can do is just put it on your credit record and it’s already there and even if you paid it off 100% in full it would still affect your credit rating since you didn’t pay it right away. I would never pay a penny to fund psychiatric crimes. I actually fought with my fathers FEP insurance that I was covered under from paying for a coerced commitment I had in my early 20’s that came out to approximately 13k and then just buried the bill on my credit record. I don’t even want other people paying such bills on my behalf. Psychiatric crimes should not be paid for.

  2. The unethical medical research conducted in the United States is often a violation Federal Law, and a violation of participants Individual Rights; supposedly protected under the US Constitution. It is also a violation of International Law i.e. The Nuremberg Code.
    Voluntary agreement of the participant is required
    Research must help society
    Research should be based on previous knowledge
    Should not cause mental and physical suffering, and avoid risk of injury and death.

    Very little (if any) of the research in this country on psychiatric drugs is in fact based on previous knowledge; but is conducted in spite of knowledge gained from previous research. Standard Clinical practices, treatment protocols, algorithms, and practice parameters for the psychiatric diagnoses are not based on the evidence base; but are often obviously contradictory to the data collected from the drug trials conducted to gain FDA approval for the drugs which are then recommended by a consensus of opinion, as ‘necessary medical treatment.’ I’ve said it elsewhere: A consensus of opinion is evidence of agreement. A consensus is not empirical evidence. It is used as a substitute for the empirical data which an ethical medical recommendation should be supported by and based upon. These recommendations which are used in Standard clinical practice do not have the empirical support demonstrating efficacy, effectiveness or safety. This being the case, it is in fact a massive fraud that is being perpetrated; in effect, psychiatric care in standard clinical practice is Human Experimentation, care that is being ‘provided’ often without Informed Consent, and worse, compelled under Court Order and forced upon in spite of the overwhelming evidence of harm. Standard psychiatric care induces iatrogenic diseases, causing disability which lowers quality of life; and inevitably leads to early death.

    I am a MadMother whose son has been a victimized because he was a victim of violent crime when he was a three year old foster child. Instead of providing ethical compassionate care he was given Risperdal—which was illegally marketed and not approved for any use in children until ten years later. It did not help him; it hurt him. He and I were blamed for the failure of this unethical treatment that did not treat his symptoms but in fact traumatized him further–he was ‘treated’ for severe PTSD, and Left Temporal Lobe Epilepsy. Both of which were from having been physically assaulted, then put in a freaking closet by a Washington State foster parent. the woman killed four infants and was not licensed for children my son’s age when he was placed in her ‘care.’

    I am disgusted, to say the very least. How in the hell could my son being victimized and traumatized lead educated professionals to conclude that my son has a genetic neuro-biological disease–it is akin to blaming the victim, and these professionals who in fact perpetrated crimes which violate the Nuremberg Code, victimized him further by the unethical treatment they provided to ‘treat’ his injuries…

    Since the Risperdal didn’t work; he was then used in the TEOSS Drug Trials and ultimately disabled. While the cost of his care was paid for with Federal Medicaid and Federal Child Welfare funds, amounting to over a million dollars in fraud; the toll paid by my son continues to be steep.

    • I am saddened for your son. I have a good friend who is very similar to your son and it breaks my heart to watch him struggle with everything.

      Thank you for sharing your story. It’s in telling our stories over and over that we might force a change in all of this. But I know that it’s not easy for you or your son.

      The fact is that they have more concern for animals that they experiment on more than they do us. We’re just supposed to shut up and take whatever happens to us. I follow your posts here in MIA and thank you again for stepping up and speaking out.