As a society, we’re addicted to drugs. Almost all of them are legal, and we’re not abusing them per se, but we want them desperately. The problem is that so many of the new prescription drugs we take are no better than old drugs that are less expensive. Since new drugs are almost always more expensive, we’re wasting money. In some cases, the older drugs are actually better – meaning that we’re spending more for less benefit. Even more concerning, ‘new’ drugs sometimes aren’t actually new at all, making their production and marketing suspect at best.
We want to start with a caveat. We don’t hate drug companies. We don’t hate people who work for drug companies. We don’t even hate drugs. In fact, both of us, as practising doctors, have seen drugs save lives, improve health and make daily life incredibly better. But that doesn’t mean the pharmaceutical industry gets a free ride.
Often, completely new drugs come to market along with a huge advertising campaign and the promise of research showing their effectiveness. The problem is that to get MHRA approval drug companies only need to show that their drug is more effective than a placebo. That’s right – effective doesn’t mean better than what is already available, it means better than nothing. And often, unless a drug company pays for a head-to-head comparison, this type of research just won’t happen.
Once in a blue moon, however, these studies do happen. The biggest and best of them was the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Drugs for high blood pressure are intended to reduce the risk of complications or death due to coronary-artery or other cardiovascular disease. There were so many drugs to choose from (at different costs) that the National Heart, Lung, and Blood Institute (NHLBI) organized and supported a randomized controlled trial to examine which was best. This study was enormous; it took place in 623 centres in the United States, Canada, Puerto Rico and the US Virgin Islands between 1994 and 1998, and included over 33,000 participants. Patients received one of four drugs:
1. amlodipine, a calcium-channel blocker;
2. doxazosin, an alpha-adrenergic blocker;
3. lisinopril, an angiotensin-converting enzyme inhibitor;
4. chlortalidone, a diuretic.
The last of these, the diuretic, was the oldest of the drugs, and by far the cheapest. However, at the end of the study, the results were clear. This old, cheap diuretic was significantly better at preventing at least one of the major types of cardiovascular disease when compared to the other, newer drugs. Since the diuretic was also significantly less expensive, it should be the drug of choice in initial treatment of high blood pressure. However, it usually is not.
The other drugs were good-faith efforts to create new molecules to treat a chronic disease. However, in many other instances, new drugs are just ‘changed’ old drugs with no expectation that they will be better. When creating drugs through organic synthesis, mirror-image molecules are created. If drug D is created, you wind up with a compound consisting of half D and half D´(the mirror image of D). The mirror image is usually inert and has no effect on the drug or the individual taking the drug, but it is left in because there is an expense to remove it. Years ago, the drug companies hit upon a brilliant idea. If they removed that non-working, mirror-image part of the pill, they could claim they devised a new drug!
Think this is rare? Ever heard of Nexium (‘the purple pill’)? Nexium is just Losec, with the mirror-image part removed. And Losec is an effective, and now generic, drug for heartburn. Losec is D + D´; Nexium is just D. There is no reason to believe that equivalent amounts of the two drugs are not the same – and research supports this. Four head-to-head studies compared 20 milligrams of Losec to 20 or 40 milligrams of Nexium. But you have to remember – half of Losec is D´(filler)! So these studies really compared 10 milligrams of D to 20 or 40 milligrams of P. Shouldn’t more be better? One would think so, but it was barely so, and only in half the studies. And, of course, none of the advertising stated that you could get the same improvement just by taking more Losec.
This isn’t the only offender. In fact, since 1990, the proportion of these ‘half ’ drugs among approved new drugs worldwide has become greater than half of those new approvals.