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News
Triclosan Under Attack
Total Toothpaste is safe, Colgate says, citing the rigorous FDA process that led to the toothpaste's 1997 approval as an over-the-counter drug. Triclosan is also an ingredient in many soaps and other cosmetics. Regulators are reviewing whether it's safe. Meanwhile, millions of Americans are putting it in their mouths every day. Colgate said Total's effectiveness and safety are supported by more than 80 clinical studies involving 19,000 people, and that it gave the FDA 98 volumes, numbering hundreds of pages each, in support of Total. Colgate submits annual reports to the FDA.
http://www.bloomberg.com/news/2014-08-11/in-35-pages-buried-at-fda-worries-over-colgate-s-total.html
Cancer Drugs: The Irrational Rationale for their Incomprehensible Prices
Cancer drug prices keep rising. The industry blames the rising costs of drug development and the business risks they must take. Some think they charge what they can get away with, and the prices go up every year.
Look at Zykadia! The drug was approved by the FDA in April of this year, and the company charges $13,200 per month for it.
Its competitor is the older drug Xalkori approved in 2011, costing $11,500 per month. In other words, Zykadia (the newer drug) costs almost $2000 more per month.
Relating to the risk that a drug they develop may not work, Novartis took that risk with Zykadia, a me-too drug. However, Xalkori, the drug it imitates, was the first of its kind. So the risk with Xalkori was greater, but Zykadia costs more!
Regarding clinical research costs, Novartis had to run a trial of 163 patients to convince the FDA about Zykadia. But Pfizer had to run two studies with 255 patients in total. More studies with more patients means Pfizer spent more than Novartis on clinical research, but Novartis drug costs more!
So, the pricing of Zykadia has nothing to do with what it cost to bring it to market, it has to do with when it came on the market. We seem to be more tolerant to high drug prices than three years ago and much greater than a decade ago when the median price of cancer drugs was about $5,000 per month (in today's dollars).
http://www.forbes.com/sites/matthewherper/2014/08/13/cancer-unpronounceable-drugs-incomprehensible-prices/?
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