Comments on: The road to nanomedicine may not always be quick or easy

By: Richard Jones

Richard Jones — Mon, 26 Jun 2006 14:01:04 +0000

That looks an interesting blog, but I’m probably too squeamish to follow it! Good luck, anyhow, and I agree with you that this is something with a real benefit to society.

By: yugyug

yugyug — Mon, 26 Jun 2006 10:36:55 +0000

I am currently particpating in a clinical drug trial in Japan. The money is definitely an incentive, but as long as adequate information is provided about the drug prior to consent, then I feel these studies have some altruistic merit. In anycase, the experience is very interesting and I am publishing an online diary about it at http://whitemice.wordpress.com/

By: nanotech

nanotech — Fri, 21 Apr 2006 09:23:29 +0000

These kinds of incidents can happen in any of the clinical trial irrespective of nature of product under investigation. All clinical scientist has to follow guidelines and cGCP to conduct study and generate data for submission to the regulatory authorities like FDA or MCA. No one will be dare enough to put their molecule under clinical test if they get a slightest hit of possible acute or chronic toxicity. However, nanotechnology based products has to be handled with extra care as by the virtue of their size they might pose a total different clinical manifestations. Recently a consumer product based on nanotechnology was recalled from the market in Germany. FDA will be more coutisious in dealing with application of (IND/NDA) nanopharmaceuticals.

Some links for more information
http://www.nanopharmaceuticals.org
http://www.nanopharmaceuticals.org/news_2006/First_nanoproduct_recall.html

By: Richard Jones

Richard Jones — Fri, 31 Mar 2006 09:16:11 +0000

Hal, I appreciate your gracious clarification.

By: Hal

Hal — Fri, 31 Mar 2006 07:19:20 +0000

I apologise for missing the point of the article. I thought Richard was saying that the suffering of these two unfortunate experimental subjects outweighed the potential good of even a cure for cancer. The Hippocratic Oath says, first, do no harm; and it seemed that Richard was advocating such a standard for scientific research. He would not be alone in doing so: the so-called Precautionary Principle extends this concept into a larger arena, and is widely supported. It is this direction of thought that I think is fundamentally misguided and which I thought was important to take issue with.

However, on reading Richard’s comment and re-reading his essay, I now think that I misinterpreted his point, and that in fact he was saying that biology is complicated, medicine is complicated, and even interventions that seem likely to be safe and effective may not work the way we expect. Hence, progress in medicine, nanomedicine, and biology will continue to be slower than we might wish.

I find this unarguable, and I assume most other people would, too.

By: Tom Wynne-Morgan

Tom Wynne-Morgan — Tue, 28 Mar 2006 09:33:49 +0000

well said. I wonder how many others in the medical community think so too? I fear that the majority grab the same end of the stick as Hal

By: Eric Arsenault

Eric Arsenault — Fri, 24 Mar 2006 06:02:52 +0000

I totally agree with Richard. Hal didn’t get the point at all.

By: Richard Jones

Richard Jones — Wed, 22 Mar 2006 08:37:02 +0000

Hal, there’s a great deal that can be written about the ethics of clinical trials, but that wasn’t really my main point here. The point is that the people who developed this drug undoubtedly did think it had a good chance of working, and they did have a lot of good scientific reasons to think that it might be a cure for cancer (at least some types, in some circumstances). We will undoubtedly learn from the inquiries that will follow whether they were too hasty in taking the drug to human trials, but the bottom line is that when confronted with the complexities of a real human, their scientific assumptions proved to be very fallible. It’s assumptions of precisely this kind that underlie judgements of the kind you imply in the phrase “something that had a good chance of working” so we’d better be very clear about how reliable these assumptions are likely to be.

By: Hal

Hal — Wed, 22 Mar 2006 00:41:59 +0000

I’m not sure we should be so quick to accept the ethical balance presented here. There are a lot more than two people struggling for their lives due to cancer or ageing. Why exactly do the two people in North London outweigh the billions who will suffer from these other conditions?

Well, of course this particular treatment was not going to cure cancer or ageing. But if someone came up with something that had a good chance of working, wouldn’t it make sense to accept an expedited path through clinical trials, even if it did increase the risk to experimental subjects?

An ethical principal that we cannot risk even one person’s life in pursuit of a treatment that could save billions seems far too conservative to me.