Corporate Responsibility for a Drug Trial Gone Bad

I’m not sure why I haven’t blogged about this case before. Everyone in the world of bioethics / health-care ethics knows about it, but maybe not everyone with an interest in business ethics, though it’s as much a story about corporate ethics as it is about health.

It’s a story about 6 healthy young British men who were paid to be part of what’s called a “Phase 1” clinical trial, to determine whether a new drug was safe for use in humans.

It was not safe. Definitely, devastatingly not safe.
Indeed, the 6 men “ended up in intensive care, their heads swollen like balloons and their immune systems seriously damaged.”

Here’s the story, from The Mirror ONE YEAR AFTER DRUG TEST HORROR…NO APOLOGY NO MONEY

The drug is called “TGN1412,” and was developed for treatment of leukemia and certain inflammatory conditions. The young men were each paid £2,000 (about $4,000) for their work as human guinea pigs. For this, they were to undergo several injections and a few days in hospital under observation. That much is pretty standard. Every new drug has to be tried on someone first (following, of course, trials in animals — which, unfortunately, don’t always give definitive evidence of a new drug’s safety for humans).

The result in this case was very nearly a worst-case scenario: all 6 men had nearly immediate, serious reactions to the drug. All of them ended up in the intensive care unit, in excruciating pain. As the Mirror puts it, “The drug was destroying their immune systems and shutting down their vital organs.”

Here are some of the ethically interesting elements of this case:

1) The company running the study had an insurance policy to help in case of adverse outcomes — but the policy is too small (£2million, or about $4 million) to cover the health-related expenses the 6 men are likely to face as a result of the drug trial.

2) The manufacturer of TGN1412, a German company called TeGenero, has gone out of business. As a corporate entity, it no longer exists. An American firm, Parexel, was running the drug trial, but has refused to accept responsibility. (This highlights one of the down-sides of the limited liability corporation. Once a corporation has folded, no one is left to take responsibility.)

3) From what I can read, the consent the men gave to participate in the trial was pretty far from the standard of “free and informed.” Well, it was free, but not terribly well informed. According to the Mirror, the men were told that the only risks were things like nausea and headache. The physician in charge of the trial apparently reassured the men that this was “certainly” not a risky trial.

I don’t have a lot to add by way of analysis, except this:

One important note has to do with the role of physicians. There’s some dispute, in the research ethics literature, about the role of physicians in clinical trials. In conducting such trials, is a physician “primarily” a health-care provider, with overriding fiduciary obligations to the patients involved, or is she “primarily” a researcher, with an overriding obligation to the advancement of science? Or, again, is she “primarily” a corporate employee or consultant or contractor? I don’t have space to offer a full argument here, but I’m of the view that physicians cannot — ever — shed their role as trusted providers of healthcare. A physician conducting a clinical trial is still a physician. (In the eternal words of Marge Simpson, “A professional in a gorilla suit is still a professional.”) No matter how useful it might be, in some circumstances, for corporations to be able to treat physicians as their private consultants, physicians remain publicly-licensed professionals, trusted and generally held in high esteem by the patients in their care. It’s quite likely that the young men in the TGN1412 were greatly reassured by the presence of a physician, and trusted that physician to protect them.

A second point to make is that this case should be studied by business ethics scholars and taught in business ethics classrooms, just as it ought to be (and likely will be) talked about by scholars and students of bioethics (and, in particular, of research ethics). It’s a case about health, and about health research, but it’s clearly also a case about corporate responsibility. How much should health-research corporations do to protect the people who participate in drug trials? How much insurance ought they carry? What attitude ought such corporations adopt with regard to the physicians (or other professionals) in their employ? And what is the pharmaceutical industry as a group going to do to better self-regulate, so that incidents like this don’t happen, given that such incidents are clearly detrimental to the industry as a whole, as well as to the public interest?

See also:

From the New York Times (last April): British Rethinking Rules After Ill-Fated Drug Trial

Relevant Books:
Case Studies in Biomedical Research Ethics
The Ethics of Biomedical Research: An International Perspective
Belmont Revisited: Ethical Principles for Research with Human Subjects

No comments yet

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

w

Connecting to %s

%d bloggers like this: