The 4-Hour Body_ An Uncommon Guide to Ra - Timothy Ferriss [205]
Next up, you could compare your drug against a useless control. Many people would argue, for example, that you should never compare your drug against placebo, because it proves nothing of clinical value: in the real world, nobody cares if your drug is better than a sugar pill; they only care if it is better than the best currently available treatment. But you’ve already spent hundreds of millions of dollars bringing your drug to market, so stuff that: do lots of placebo-controlled trials and make a big fuss about them, because they practically guarantee some positive data. Again, this is universal, because almost all drugs will be compared against placebo at some stage in their lives, and ‘drug reps’—the people employed by big pharma to bamboozle doctors (many simply refuse to see them)—love the unambiguous positivity of the graphs these studies can produce.
Then things get more interesting. If you do have to compare your drug with one produced by a competitor—to save face, or because a regulator demands it—you could try a sneaky underhand trick: use an inadequate dose of the competing drug, so that patients on it don’t do very well; or give a very high dose of the competing drug, so that patients experience lots of side- effects; or give the competing drug in the wrong way (perhaps orally when it should be intravenous, and hope most readers don’t notice); or you could increase the dose of the competing drug much too quickly, so that the patients taking it get worse side-effects. Your drug will shine by comparison. You might think no such thing could ever happen. If you follow the references in the back, you will find studies where patients were given really rather high doses of old-fashioned antipsychotic medication (which made the new-generation drugs look as if they were better in terms of side-effects), and studies with doses of SSRI antidepressants which some might consider unusual, to name just a couple of examples. I know. It’s slightly incredible.
Of course, another trick you could pull with side-effects is simply not to ask about them; or rather—since you have to be sneaky in this field—you could be careful about how you ask. Here is an example. SSRI antidepressant drugs cause sexual side-effects fairly commonly, including anorgasmia. We should be clear (and I’m trying to phrase this as neutrally as possible): I really enjoy the sensation of orgasm. It’s important to me, and everything I experience in the world tells me that this sensation is important to other people, too. Wars have been fought, essentially, for the sensation of orgasm. There are evolutionary psychologists who would try to persuade you that the entirety of human culture and language is driven, in large part, by the pursuit of the sensation of orgasm. Losing it seems like an important side-effect to ask about.
And yet, various studies have shown that the reported prevalence of anorgasmia in patients taking SSRI drugs varies between 2 per cent and 73 per cent, depending primarily on how you ask: a casual, open-ended question about side-effects, for example, or a careful and detailed enquiry. One 3,000-subject review on SSRIs simply did not list any sexual side-effects on its twenty-three-item side-effect table. Twenty-three other things were more important, according to the researchers, than losing the sensation of orgasm. I have read them. They are not.
But back to the main outcomes. And here is a good trick: instead of a real-world outcome, like death or pain, you could always use a ‘surrogate outcome’, which is easier to attain. If your drug is supposed to reduce cholesterol and so prevent cardiac deaths, for example, don’t measure cardiac deaths; measure reduced cholesterol instead. That’s much easier to achieve than a reduction in cardiac deaths, and the trial will be cheaper and quicker to do, so your result will be cheaper and more positive. Result!
Now you’ve done your