health news tool #1: you are not goo

At the risk of getting fire-bombed by PETA, let me describe Tool #1 this way: test tube goo and lab rats are not people. This seems pretty self-evident, doesn’t it? Yet you’ll be amazed (and infuriated) at how many breathless media reports of fabulous new discoveries don’t bother to explain whether the miracle in question worked for people, rats, or a glob of cells in a petri dish. This is the first and most fundamental tool for evaluating a news report, whether you’re reading about it in the USA Today or in a medical journal, and you should actively seek out this information. (In fairness, if you’re reading a medical or science journal article, it’ll be impossible to miss.)

Amazing Cancer Cure….for Rats

To understand just how important this factor is, consider this: fully 95% of new cancer drugs that looked oh-so-promising in test tubes or in lab rats fail by the clinical trial phase. And while other drugs do a little better (e.g., heart drugs fail at a “mere” 70% by phase III clinical trials), they still fail more than half the time.

There are a variety of reasons drugs flunk out of the process, but chief among them are:

• Toxicity: the drug was too toxic in people (liver damage being a big one for cancer drugs)
• Metabolism: the drug worked great in rats, but humans didn’t metabolize it so it never took effect
• Distribution: it killed (or protected) lots of cells in the petri dish or in rats, but in humans not enough of the drug reached the target

With this kind of failure rate between in vitro (cells in a petri dish) and clinical (human) trials, why bother to report the petri dish experiments at all? The answer is complicated, like the drug discovery process itself. Let’s start with a high level (like, as-seen-from-the-moon high level) view of the drug development process:

Those early in vitro and animal studies are largely translational research. Translational means studies aimed at taking the “basic” (also called “fundamental”) research and inching it towards “applied” — something we can use. It’s akin to the difference between theoretical physics, where researchers might struggle to create a new sub-atomic particle (making us all ask: why?), and applied physics, like the research that brought you wrinkle-free chinos (I know, I know…again, why?).

In drug development, fundamental research includes efforts to simply isolate a new chemical or manufacture a slightly different structure. For example, let’s say a vine is known for killing off its neighbors. Researchers might work to identify and isolate the toxin produced in its roots (sort of early phase Little Shop of Horrors).

Translational research picks up these interesting chemicals, whether they’re good interesting (keep cells in a petri dish from aging) or creepy interesting (cause cells to explode on contact), and begins to experiment with potential uses. This is where, for example, the compound taxol, first isolated from the Pacific Yew tree, was found to be effective at killing certain cancer cells, eventually leading to the drug Taxol (paclitaxel), the chemotherapy so many cancer patients love to hate.

Translational research can branch in a number of directions, like research to figure out how to package a drug for human consumption or distribution, or research to figure out how to industrialize a very laborious drug extraction method. More importantly, this is where animal studies happen, to see if the new chemical has the same effect inside a complex animal (like a rat or a human) that it had in a glob of cells in a petri dish. And this is where things fall apart for a lot of drugs.

It should be pretty clear that a tremendous amount of research goes into a chemical before anyone even starts fantasizing about stock prices (and why that research is critical). The problem is, what happens when your average Joe Blogger gets wind of these experiments? Or when a thoughtful science report gets a headline-grabbing makeover? Or when someone fishing for a quick buck reads of a petri dish breakthrough? What happens is a headline like this: Curry cures cancer. This is where your toolkit comes in.

Recap: You are not Goo

Nobody I know

The next time you read of a fabulous new drug that sounds like a death ray for the common cold, the first question you ask is “for who?” (or, for whom according to my 6th grade English teacher). Did it cure people or mice or goo? Any description of its effect on cells is a red flag, especially if it’s the only description of effectiveness you hear (rather than, say, tumor shrinkage or symptom relief). Ditto any other new miracle product: if it’s anti-aging, did it result in smoother skin or is the result explained in terms of how long “cells survived”?

If the article describes the effects in terms of organs you can identify on your own body (skin, for example, rather than cell membrane), chances are that the research was at least conducted on animals — but don’t assume this. Read closely for this information, and if it’s not in the media report, then try emailing the reporter for the actual journal article title and publication and try to find it online and read it for yourself. Or, try Google to see if a trusted source (like those in PlinkTank’s resources menu) has covered it.

The bottom line: in vitro and animal studies have a long, long way to go before they are proven relevant to you. If you decide to change your lifestyle around these studies, you need to think carefully about unintended consequences. (Do I even need to mention the great butter-versus-margarine debate of the last few decades?)

What about scary-hard decisions, like cancer treatment, you ask? What if you don’t have the luxury of sitting back and waiting a decade for “more research”? That’s when you most need a set of trusted analytic tools. If there is one consistent trend in drug reporting it’s this: time and again, everyone from the researchers to the investors is “surprised” by the serious side effects of new drugs. Everyone, that is, but the patients–they’re just horrified. Even when you’re facing a miserable lesser-of-two-evils choice, you should still demand to see the facts behind the claims. You don’t want to waste your time or compound your misery.  This idea was at the heart of the debate over Avastin for breast cancer patients–that oncologists would, out of an admirable desire to offer hope, oversell a drug to agonized patients. You still have every right to choose a potentially dismal quality of life in exchange for uncertain benefit, and the risk of an even speedier death. The purpose of an analytic toolkit in a nothing-but-bad-choices scenario is to help you make that choice knowingly and intentionally, and to make room for the soul-searching that that kind of decision requires.

References

Stephen Neidle, ed. Cancer Drug Design and Discovery

On recent drug development failure rates:

CancerNetwork, “Phase III failure rates in oncology drugs unacceptable”
See also Neidle, at page 8.