Archive for the ‘glaxosmithkline’ tag
Treatment Effects

What ever happened to the part of the Hippocratic Oath that says «do no harm»?
Tucked away in one of my wife’s magazines this week was an advertisement for a drug called «alli». The drug, manufactured by GlaxoSmithKline, is a non-prescription version of an existing, so-called «weight-loss» drug called Orlistast (the prescription form of the drug is called «Xenical»), a lipase inhibitor (more on that in a moment). As far as I can see, the only difference between the prescription and non-prescription is the dosage, 60mg for the over-the-counter version versus 120mg for the prescription version.
Orlistat has to be one of the worst pharmaceutical products on the market right now.
What bothers me most about the drug is that it doesn’t seem to do anything useful at all. It certainly does things to you. A lipase inhibitor, for those who don’t know, is a chemical that binds to digestive enzymes that break down triglycerides (fats) from food that is eaten into monoglycerides and free fatty acids that the body can absorb and process. If these fats are not broken down, they simply pass through the digestive tract. As a result, a person who takes this drug and then eats too much fatty food will experience the «treatment effect» (GSKs term, not mine) of too much fat simply sliding through the digestive tract. Yuck.
It is this «treatment effect» that is supposed to show the patient that the drug is working. In reality, the only thing that Orlistat does is punish someone who cheats on their diet. I’m not sure when the only side effect of a drug becomes a main reason for taking the drug, but I’m sure someone will be suing GSK over this drug (either for this effect or for the marketing claims of a 50% reduction in weight versus not taking the drug).
The other potential health risks (including vitamin-deficincy diseases and conflicting research about colon cancer) aside, the drug has no positive benefits. In order to be effective, according to the marketing literature, you must “commit[] to a reduced-calorie, low-fat diet.” I’m not sure how they conducted a controlled study of the drug when there are also the free variables of «reduced-calorie diet», «low-fat diet», and, given the requirement implicit marketing materials, «exercise». What diet plan does not include these? Would there really be a 50% weight-loss benefit for taking this drug and doing the things you are supposed to do to lose weight? Given that the weight-loss industry is enormous ($35 billion according to CBS news), GSK has every incentive to push another drug onto the market, even if that drug has no pharmaceutical value at all.
The drug was just approved this February, and this is the first marketing material I’ve seen for the drug «alli». I’m not usually one for litigation, but I think this is an instance where the threat of a lawsuit will pull a legitimately bad product off the market.










