Why you should be suspicious of new drugs
There is a simple financial fact you need to be aware of. Drug companies can only make lots of money on patented drugs for which they effectively have a monopoly and hence can charge a high price and fund massive marketing campaigns. Once a patent runs out, usually after fifteen years, anyone can produce the drug so the price and profit comes right down. Metformin, for example, is off patent and much less expensive. (More on this drug in a minute).
A case in point is Avandia (rosiglitazone), one of a new family of diabetes mellitus drugs called glitazones (also known as thiazolidinediones), licensed over a decade ago to treat diabetes. It works by increasing your body’s sensitivity to insulin. Sounds like a good thing to do. It’s very effective at bringing blood sugar levels down, but at a cost. Well-known side effects include: significant weight gain, fluid retention, a raised risk of heart failure and a link with osteoporosis.
What you may not have been warned about is growing evidence that it can increase your risk of a heart attack even though the first warning bells were sounded four years ago. The evidence for harm continued to grow but so too did the prescriptions. By 2009 around 500,000 prescriptions were written for the drug.
By July 2010 both the American drug regulator – the FDA – and the European one – EMA (European Medicines Agency) – considered taking it off the market and strengthening the warnings about it. The EMA did neither.
Behind the scenes a fight was on to keep the drug on the market. For instance a major plank in GlaxoSmithKline's evidence was a big trial that reported no increase in the risk of heart disease among nearly 4,500 patients getting Avandia. Called Record it began in 2002/3 and the results were published in 2009.
However Dr Thomas Marciniak, a scientist working for the Food and Drug Administration described it as “seriously flawed” because, he ......
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