Clinical Trials Go Shopping for Subjects

Human beings are the raw material of science, and there are rich rewards for anyone who is willing to take one for the team. In my case, my main motivation was curiosity. And the crisp £5 notes I was given for each hour of time with my brain. During my years at the University College London, I was a lab rat in the psychology department and its Institute for Cognitive Neuroscience several times over.  It was an experience I would recommend to anyone. I got free tea, biscuits and some pocket money. Not to mention lovely images of my own brain (yes, that’s my brain in the background of the artwork above).

The business of testing on humans is a minefield. Whenever anything goes wrong (and when it does go wrong it goes very wrong), it makes a big splash. The drug companies are denounced as evil, the subjects as greedy, and everyone agrees that acting the human guinea pig is about as tempting as having your eyeballs poked out. But that is to miss the point. If doctors and scientists can’t test on humans, they can’t make new medicines. And there are benefits of taking one for the team that go way beyond a stack of crisp £20 notes. If researchers are developing a new treatment for something you’ve got, and you’re in the experimental group, you essentially get first dibs. If you’re getting the placebo but the results of the experiment were positive, you’re first in line for the new wonder drug. 

The nearest I have ever come to a drug trial was an experiment which showed that anti-depressants play havoc with short term memory. It also gave me the rare opportunity to try said anti-depressant in the presence of a trained medic, and showed that sitting blankly in front of a panel of doctors trying in vain to remember the sample story you told them just a week before is really rather embarrassing. I also once spent an hour doing reaction-time tests while high as a kite on nitrous dioxide, and I can categorically say that it’s called laughing gas for a reason!

Of course clinical trials aren’t always delightful or hazard free. When it comes to testing new pharmaceuticals, trials can be a whole minefield of trouble. People die, vast quantities of money are wasted and the lawsuits – oh, the lawsuits. The means are a hotbed of controversy and scandal, but in the end we do get a few miracle pills.

By the numbers:

2,000: amount (in British pounds) paid to the six male volunteers of London’s Northwick Park Hospital, which tested the anti-inflammatory compound TGN 1412. Upon receiving the test drug, each man went into multi-organ failure and nearly died. Researchers now believe earlier test on animals missed this side effect due to the sterile conditions lab rats live in.

20: amount (in British pounds) I was paid to let researchers at the Institute for Clinical Neuroscience in London peer into my brain with fMRI.

15,279: number of trials registered at ClinicalTrials.gov that are currently recruiting volunteers.

90: percentage of Phase I (first human-safety) trials that fail.

5,413: number of sponsored clinical trials registered with the FDA in 2003.

36: number of new drugs the FDA approved on average per year between 1994 and 1997. 

23: the same number between 2001 and 2004.

6.5: average number of years it takes to conduct enough animal and Petri-dish experiments to determine a drug is promising enough to be tested on people.

7: average number of years it takes to test the drug on people.

1 billion: average cost (in dollars) to get a single drug to market.

11: percentage decline in the number of principal investigators leading clinical trials in the U.S. between 2000 and 2002.

8: percentage by which the number of investigators working on FDA-approved trials abroad increased.

29: percentage of clinical trials that GlaxoSmithKline (a U.S. company) conducted abroad in 2005.

50: percentage of clinical trials that GlaxoSmithKline is expected to conduct abroad this year.

2 billion: predicted spending (in dollars) on outsourcing clinical trials to India by 2010.

42: number of countries that approved thalidomide as a sedative and antinausea drug before its tendency to cause birth defects was discovered.

2 out of 3: number of judges in the U.S. Court of Appeals for the District of Columbia that upheld the constitutional right of access to experimental drugs last May in the case “Abigail Alliance v. Andrew von Eschenbach.”

A lot: number of lawsuits filed against drug companies for knowingly covering up or under-reporting dangerous side effects of their products, such as Vioxx (a painkiller that raises the risk of heart attacks), Seroxat and similar drugs (SSRI antidepressants that raise the risk of suicide among teen users), Baycol (a cholesterol-lowering drug), hormone replacement therapy (treatment for postmenopausal women that can increase the risk of breast cancer)...and...and....you get it.