Forbes reported that Astra Zeneca sponsored a drug trial where their lipid-lowering drug, Crestor, went head-to-head with Pfizer’s Lipitor, a strange battle from the start since many considered Lipitor the underdog in the battle. But the results showed no difference in outcome, which for this study was how blockages in the arteries of the heart progressed after treatment.
In other words, the trial resulted in a draw, and delivered a huge blow to Crestor, since it will retain its patent, and associated high price tag, until 2016, while Lipitor’s constituant, atorvastatin, will be available as a generic this week at a fraction of the price of the brand-name cholesterol-lowering meds (http://ti.me/tZf3j6).
This story was intriguing in many ways. First, I think it’s great that the researchers published the results of the study, which Astra Zeneca funded, in the New England Journal of Medicine. It would have no doubt been much easier to sweep these results under the carpet, where they’d join the other dark data of failed clinical trials (http://bit.ly/tn7dBr).
Second, I think it’s important to set a precedence that drugs intended to treat the same condition go head-to-head in properly designed clinical trials. As consumers and patients, we deserve to know how each treatment measures up.
So kudos to Astra Zeneca for taking the high road. The results of the trial will cost the company money in terms of decreased sales. But they made infinite strides in forging a transparent relationship with their customers.
Photo via Flickr / Grumpy-Puddin
A huge boost to treatment for the Hepatitis C virus (HCV) is on the horizon, as two pharmaceutical companies are set to release new drugs to market. And with development complete, the marketing war begins.
Forbes reports that Merck has won FDA approval for Victrelis, and the drug, which costs $35,000 for the course of treatment, will hit pharmacies’ shelves by next week, along with the company’s targeted marketing campaign.
But Merck is on the clock, since a favorable approval from the FDA expected on rival drug, Incivek, manufactured by Vertex Pharmaceuticals by the end of the month.
A quick look into the Phase III studies conducted by Merck and Vertex reveals that both HCV drugs are protease inhibitors intended to be given in combination with other currently available treatments. And a paper published this past February in Science Translational Medicine provides a plausible explanation why, going forward, choosing the proper drug cocktail for each patient will be crucial.
It seems that HCV can rapidly mutate, perhaps even faster than HIV or Hepatitis B, and successfully combating this disease will require substantial efforts in personalized medicine:
Overall, this study predicts that rapid emergence of HCV protease inhibitor resistance in patients, particularly those with genotype 1a infection and with high viral loads, is expected. Combination therapies of direct antivirals with/without IFN+/-RBV would be promising to combat drug resistance. However, as with HIV, they need to be chosen carefully and with regard to both preexisting and on-treatment generated drug-resistant variants.