A “panel of experts” at the Food and Drug Administration voted 12-4 yesterday in favor of allowing AstraZeneca to market its cholesterol pill, Crestor, to patients with healthy cholesterol levels. In other words, we can expect to see a big push by AstraZeneca drug reps to convince physicians to prescribe even more statins to patients under the guise of promoting public health.
The most disturbing thing about this decision is that it has very little to do with public health and everything to do with creating an additional “market” for AstraZeneca. The UK-based drug maker is currently facing fierce potential competition from generic drug makers, and this initiative is largely about expanding its sales to stem the projected revenue losses once Crestor goes off-patent.
In fact, it’s quite compelling that the entire decision stems from a study that clearly implicates inflammation as being the key factor in coronary artery disease:
The company based its request on a much-heralded study published last year, showing a 44 percent reduction in heart problems even among patients with normal cholesterol levels. All the patients had elevated levels of the so-called C-reactive protein, however, a key indicator of inflammation that can lead to clogged arteries, causing heart attack or stroke. Scientists are still unsure whether the positive results were due to lower cholesterol or C-reactive protein, since Crestor reduces both [ed. emphasis mine] .
Bottom line – It’s not the LDL, it’s the inflammation. And you don’t need a statin to reduce your overall levels of systemic inflammation.
Until this issue gets addressed at a higher level, the FDA will continue to be overly influenced by Big Pharma when it comes to most issues of public health. In the meantime, remember that drug companies are businesses with profit motives – just like physician practices.