This drug may cause cancer!

We hear about the ubiquitous medical breakthrough or new drug development in the media on an almost weekly basis. Journalists regularly bubble excitedly about a critical or earth shattering breakthrough in cancer research or some other disease that will likely be on the market in ‘only’ 5-10 years. The fact that 5-10 years later we still have no cures and the breakthrough is consigned to the rubbish heap is usually due to the fact that the “discovery” was based on animal studies – the results of which did not extrapolate well (or in fact at all) to humans.

There was one such claim this week though that I found very unusual. Natpara, a (hormone treatment) drug to control low blood calcium levels in patients with hypoparathyroidism, has been approved by the U.S. Food and Drug Administration. It should be available commercially in the second half of 2015. What I did find interesting in this case however is that the drug carries “a boxed warning that bone cancer (osteosarcoma) has been observed in rat studies with Natpara.”

Now I’m not saying that this drug is not going to be successful, and indeed I hope that it will be, but it causes bone cancer in rats and yet it was approved for human use. My point here being is that why were the studies carried out in rats if the results are going to be disregarded? Isn’t the whole premise for using animals supposed to be based on eliminating safety concerns prior to clinical trials? Why did it even proceed to human trials let alone gain FDA approval?

We all know the ratio of drugs that succeed in animal trials but fail in humans (now over 90% - these are the FDA’s own statistics not mine) and this causes grave concerns about the potential human cures that may have been inadvertently discarded due to their failure to provide good results in animals. This Natpara situation seems like a revolutionary step forward – approving a drug, which causes cancer in rats, for human use is surely an acknowledgment that rats differ to humans and are therefore not suitable models for human disease.

So, could we perhaps leave the rats and other animals alone now and focus on HUMAN studies?  Or is this too much like common sense?

Further info: http://www.clinicaspace.com/News/shires-5-2-billion-bet-pays-off-as-nps/362127

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