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Week in Review Editorial: 7 to 13 September

Takeda can finally breathe a sigh of relief, as Actos doesn't cause microvascular events...

Actos is safe
Takeda can finally breathe a sigh of relief. Actos doesn't cause microvascular events. The PROactive study published in JAMA has supported Takeda's original data, which is more than can be said for GlaxoSmithKline.

Takeda's flagship diabetes drug is now the only thiazolidinedione to have safety data included in its labelling. A good thing too, considering that Actos is the company's best selling drug. The focus now shifts back to GSK. Japan's largest pharmaceutical company has shown that even slight molecular differences can create yawning chasms between what are essentially very similar drugs.

Can GSK ever get a break? Not for Avandia, it seems. It has even been suggested that GSK's own data provided a signal for a cardiovascular safety problem. Some experts have extrapolated this to cast doubt on the whole class, but Actos has come up smelling of roses.

Safety first
Drug safety continues to dominate the headlines. An analysis in Archives of Internal Medicine exposed increases in dangerous side effects and deaths from approved drugs in the US.

The study adds to increasing criticism of the FDA's lack of progress, including its handling of serious problems connected with Merck's Vioxx, which was removed from the market in 2004.

The study authors said the increasing incidents of serious injury showed that the existing system was not adequately protecting patients and emphasised the importance of recent reports urging far-reaching legislative, policy and institutional changes.

The FDA defended itself by saying it was aware of the growing number of reported problems and took them seriously, but the reason for the increase was not completely known.

Risk perception management
The concept of risk-avoidance dominates the drug approval process. One the one hand, risk is minimised through rigorous testing, but no system is perfect. A number of high-profile drugs have slipped through the net and will continue to do so, as long as public demand for life-saving treatments continues to rise.

Public perception of risk itself is a sensitive subject. People perform risk/ benefit assessments every day, even unconsciously. But for Pharma, making a mistake can have profound implications. Can anything ever be totally risk free? Of course not.

Again, it's how the industry is perceived that continues to confound and surprise in equal measure. One the one hand, the industry produces products of incredible benefit to the public, helping to keep us healthy. At the same time, however, Pharmaís business model can foster mistrust of the motives behind drug discovery, development and marketing.

Is Pharma doing all it can to be transparent? Is the healthcare industry able to educate the public on a much deeper level than it is currently doing? Can regulatory bodies create a better interface between the public and healthcare? The current changes in the industry are a challenge, but they are also a huge opportunity to build a better and healthier future.

30th September 2008

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