QDIS Blog

It seems 2006 will be the year of finding out all kinds of things about drugs once though safe.
From Vioxx to everyday over-the-counter pain relievers we have seen unintended consequences raise its ugly head. The latest is the proton pump inhibitor class of compounds including Prilosec, Nexium, Prevacid, Aciphex and Protonix.

Heartburn drugs raise risk of hip fractures: study | Health | Reuters.com

The study is fairly large; 150,000 Britons over the age of 50. It found they had 13,556 hip fractures which is higher than expected. There was also a correlation to fractures with how long the drug was used and how high of a dose was taken. This is likely due to the drugs inhibiting calcium absorption. The good news is that by increasing calcium consumption these side effects can likely be overcome although studies would need to be done to prove that.

Here is a quote from the article.

“At this point, physicians should be aware of this potential association when considering (proton pump inhibitor) therapy and should use the lowest effective dose for patients with appropriate indications,” said study author Yu-Xiao Yang.

The report on the study, published in this week’s issue of the Journal of the American Medical Association, also said that elderly patients requiring long-term and high-dose drug therapy should consider increasing calcium intake.

I have always said that some of this problem is that pharma companies do not want to find out potentially negative information and avoiding doing studies that have a potential for a large downside but little to no upside. While I understand this from a business perspective, I think if there is any data that there could be unintended consequences, they should be investigated.

Technorati Tags: Aciphex, drug safety, Nexium, Prevacid, Prilosec, proton pump inhobitor, Protonix

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This Forbes article continues on what will likely be a major trend in 2007 for big pharmaceutical companies; downsizing if the sales force, especially internationally.

Analyst: Big Pharma Wields Axe - Forbes.com:

I’ve commented on this previously and think that it is something that has been a long time in coming. This report even believes that Pfizer who started this trend, may get rid of even more in its sales force. They have already let 2,200 people go but the article states that the international sales force of ~20,000 could be downsized by 30% or another 7,000 positions.

While I am always sorry to hear about job losses in the industry, this is an area I think could use it. With the lacking pipelines in many companies today and changes on how medications are purchased the need for them has diminished.

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I spent some time working in Seattle and still keep a close eye on the biotech industry there. I was glad to see that Zymogenetics has submitted a new drug application (NDA) to the FDA for Thrombin. Thrombin is a genetically engineered human protein that inhibits bleeding.

The Seattle Times: Business & Technology: ZymoGenetics seeks OK to market drug

I do have a former colleague of mine who now works for Zymogenetics and I do like to see them prosper. Having said that, I am a little concerned that the patient size was fairly small; 411 patients, only half of which were on their drug, the other half received the standard of care; that being a cow derived product . They both worked equally well but those treated with the genetically engineered product did not develop antibodies to the protein; only 1.5% in the Thombin group vs 22% treated with the cow derived product.

The market for the drug is not huge; King Pharmaceuticals’ Thombin-JMI is about $250 million per year in sales. Zymo’s Thombin product will likely replace most of that and have some growth perhaps being a $400-500 a year product. Zymo’s product is being manufactured under contract with Abbott and there are no capacity limits as there is with the KIng Pharmaceutical product.

Technorati Tags: Zymogenetics, Thrombin

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