Drug safety, IP and innovation news of the week

Bill Clinton is backing Brazil’s trial use of the international compulsory licensing agreements for anti-retroviral AIDS therapies, which allow them to make the drugs and pay the patent-holding pharmaceutical companies a fair but reasonable compensation. Bill also is working to get more drugs made generic so they can be made and sold more cheaply.

The US Senate has approved an expansion of the US Food and Drug Administration’s powers to monitor drug safety, change drug labeling, regulate drug advertising, and otherwise do the job its supposed to be doing. One important provision is the requirement that the FDA expand its monitoring of the safety of drugs after they’ve approved its use. Until now that process consisted of collecting and filing voluntary adverse reaction reports from physicians. Now they are required to establish a monitoring system analyzing data from tens of millions of patients. The bill is expected to pass in the House. Big Pharma is even happy with the new FDA powers, after having knocked out a provision which would have allowed the importation of cheaper drugs from Canada.

One of the ways to more rapdily ensure drug safety, before it hurts any human patients, is by testing drugs on animals with human genes, creating human immune, nervous, reproductive or histological tissues. Consequently the UK has just legalized the use of human-animal chimeras in experimentation, to the sturm and drang of bio-con echo chamber. Another way to ensure drug safety is to model genes and body systems in computers, and test the drugs “in silico.” This week another step in that direction was taken by a Swiss team who completed a dynamic computer model of the cellular development of the C. elegans nematode.

The US FDA is approving a 24/7/28 menstruation suppression pill, Lybrel, otherwise know as a regular birth control pill without a set of blanks. Biocons shoul be happy with this one since menstruation is actually a very unnatural activity: until invention of contraception, few of our ancestresses menstruated more than a couple times. They got pregnant shortly after their first period, suppressed menstruation through nursing after birth, and then died. Modern menstruation causes mood swings, pain and endometrial cancer. Stop that unnatural bleeding!

The UK Daily Mail reviews the spread of the black market in cosmetic pharmaceticals, from diet pills, to sex drive enhancers, to pills that give you a tan.