If the 21st Century is going to be the bioscience century, as I believe it will, then every year will feature significant developments. However, I suspect that 2008 will, in particular, see the dawning comprehension that the tiny genetic differences between one person and another are more important than previously suspected, and are part of the reason why we get so many conflicting reports on issues like drugs and nutrition.
I’ve had lots of people complain to me that researchers don’t seem to be able to make up their minds. One report will suggest that coffee is good for you because they are high in anti-oxidants; then shortly after that another will suggest that they have no value as anti-oxidants, but can be bad for your heart, or your blood sugar levels. Some studies say vitamin D can help fight certain kinds of cancer, then others come out that seem to indicate that it doesn’t help at all. One report will say that men should eat more grapefruit, and another suggest that it’s bad for them. Meanwhile, drugs that seem very promising in stage II clinical trials, turn out to be disappointingly ineffective in stage III clinical trials, or have unsuspected, and unacceptable, side effects.
I believe that what we will find is that all of these conflicting opinions or results are correct – for different people. It may be that diet can help some people manage their cholesterol levels, for instance, while even extreme changes in diet will not affect cholesterol levels at all. Some drugs may work very well for certain people, but not at all for others, or have unacceptable side effects.
The problem is that, until very recently, researchers have generally assumed that one genotype fits all – or rather, all genotypes will respond the same way to different diet or drugs or treatment. Ironically, we already know this isn’t true, that SNPs (Single Nucleotide Polymorphisms – the subtle genetic differences between one person and another) do make a difference. For instance, there are already drugs, like Herceptin, a drug used in the treatment of breast cancer, which are known to be effective only with patients that have two specific genetic markers. If they don’t have those markers, then there is no point giving them Herceptin, because it won’t help them.
But pharmaceutical and nutritional researchers aren’t used to screening for genetic differences – and therefore aren’t generally set up to do so. The net result is that we are almost certainly throwing away valuable research studies, and discarding effective drugs, because we’re trying to apply them to too broad a population.
Moreover, at least in the pharmaceutical industry, there’s an institutional bias to avoid this kind of screening. Big pharma has dined out on developing blockbuster drugs that are sold to millions of people and bring in billions in revenues. More careful screening, and applying a new drug only to a small percentage of the market, means selling millions of dollars of drugs to thousands of people – a prospect major pharma companies don’t like, given the amount of money they have to spend to get a new drug approved.
Yet, they are only considering part of the equation. If they screened for genetic appropriateness, they would probably find that they could get more drugs through approvals. The most expensive part of the drug approvals process accrues from those drugs that make it to stage III clinical trials, and then fail and are discarded. If the number of such failures were to drop by an appreciable fraction, as I believe would happen, then the cost of getting drugs approved would drop significantly.
There would be a cost to society as well, though. The costs of drug research and approvals would still be high – but now those costs would be spread over a much smaller population, which would mean that the cost per dose would have to be significantly higher. Offsetting this is the fact that such drugs would be dramatically more effective for those people for whom they were appropriate. We would, therefore, have dramatically more effective drugs at substantially higher prices, when what we want is more effective drugs at lower prices. Unfortunately, that’s not the way reality works – at least, not in the short-run.
