Discussion

From Cyberlaw

There are all sorts of practical and ethical issues raised in this story that is dominating the news in England. Apparently, it's by far the worst drug trial results that they have ever had. Of particular interest to us is that the drug was a biological drug, not a chemical one. Some are beginning to speculate that this may have been an enabling factor in this disaster. The question this poses, of course, is whether there needs to be extra precautions for biological-based drugs trials, given their novelty and our relative lack of understanding about how they work.

One possibility, it seems to me, is that since bioloogical drugs are often specifically tailored for human genes, the initial round of animal testing may no longer be a reliable indicator of how humans will react to the drugs. If so, this would require radical rethinking of the trial process for biological druges, and if the problem is bad enough, it may call into question the ethical feasibility of testing of this entire class of drugs. One thing is for sure (in my mind): there is a lot of money at stake, and if there are deep ethical problems with the entire class of drugs, then many powerful, moneyed interests will do their best to obfuscate and bury them.

Here's an excerpt from the article on the point (I heard a story on BBC radio this morning that also suggested that the biological nature of the drug might be a leading explanation of what went so horribly and unprecedentedly wrong with this trial):

"It is increasingly likely that the drug itself, given at the right dose, was to blame - an explanation that could have very serious consequences for research into the biological drugs called monoclonal antibodies which are the bright hope for better treatments in the future. The trial drug is not a chemical but a biological product, a genetically engineered "humanised" protein. Unlike the old chemical entities, these monoclonal antibodies are designed to be accepted by the human body, which experts say makes it difficult to work out by animal testing what dose would be toxic to humans."

-Seth

• Here's a BBC News article discussing the failed trial of TGN 142. In addition to explaining how and why the trial might have gone awry, the article cautions against abandoning monoclonal antibodies as a source of disease treatments, and offers several suggestions for designing future clinical trials of these drugs that might be safer and more accurately predictive. The situation in England is not good, to be sure, but it's important not to overreact... DVorhaus 12:21, 17 March 2006 (EST)

This is a nice article you link to, DVorhaus, but I came away from it with a rather different impression than the one you give. The article says:

{Dr Glover carried out a large number of studies into monoclonal antibodies in the 10 years he spent as chief medical officer at Cambridge Antibody Technology. He said that, in this case, animal studiesmay have given falsely positive safety and effectiveness results prior to the human trial. He told the BBC: "This is a novel target, an antibody against human CD28 on human white blood cells. "Therefore, there may be differences in animals, and tests may be very difficult to do or interpret."}

The good doctor Glover then goes on to discuss "one possible way" of testing these drugs. To me, this sounds like a rather frank admission that animal testing of these drugs may not be reliable in the way we normally depend on their being. This, I take it, would be a rather significant admission from an ethical standpoint. Is there not equally a danger of underreaction? How many lives before the moral questions become acute? (i'm not being facetious; i think it's a tough question) -Seth