Wednesday, June 28, 2006

Bad Math?

I have repeatedly warned you - Don’t Trust Them. Included along with religious zealots and politicians are, of course, the Pharmaceutical Companies. Merck Corporation produced and congratulated themselves on the sales of its pain killer, Vioxx. Vioxx is a COX-2 inhibitor classified as an NSAID (non-steroidal anti-inflammatory drug).

Here’s how it works. Your body produces a particular lipid called prostaglandin. Prostaglandin molecules do many things including interact with cells in the smooth muscle of your vascular system (to regulate constriction), spinal neurons (to regulate pain), and blood platelets (which can affect cell aggregation). Prostaglandin is first built up from a fatty acid molecule and one particular step in this molecule building process involves oxidation of a precursor of prostaglandin. The enzymes needed to facilitate this particular step are known as a cyclooxygenase. In short, they are referred to as COX-1 and COX-2. NSAIDs work to inhibit COX enzymes.

COX-2 is associated with tissue inflammation and therefore, pain. However, by inhibiting prostaglandin production you also alter the balance of other molecules closely related to the prostaglandin pathway like thromboxane and prostacyclin. This alteration could, hypothetically, lead to cardiovascular problems such as myocardial infarction. This is bad.

Originally, before 2000, Merck claimed that Vioxx was safe. People died. Merck removed Vioxx from the market in 2004. Then Merck claimed that Vioxx is only dangerous after 18 months of use. Now, according to the New England Journal of Medicine, it seems that many problems occur only 4-6 months after taking Vioxx and some patients experienced problems even earlier. The investigators for Vioxx claim that they only had “one-half the safety” data to analyze.

WHAT?! Half the data? Are you actually telling me that they had the ethical audacity to publish a paper, on a for human consumption product, before all the data were in? Worse, am I supposed to believe that they could only report on the data from the last half of the study before they had the first half? They’re lying! As is usual with pharmaceutical companies, their associated researchers cherry picked the data and the team supervisors and the corporate investors were happy. Merck, a company that at any time, can tell you their net worth, liquid assets, liabilities, stock exchange value, and a thousand other accounting notes suddenly claims “bad math.” Give me a break!

What is the cost of this cherry picking? At least 28,000 deaths domestically (FDA estimate) and perhaps 70,000 deaths internationally. Now that really is bad math.

-Just a peasant
Photo by Daniel Watson