QDIS Blog

I listened to the podcast of the Newshour on PBS today and they had a good segment on the FDA looking into irradiation as a way to kill off harmful

FDA Weighs Approval of Irradiating Produce

It is a good piece and worth watching of listening to given the number of such outbreaks in the past year.

Technorati Tags: e coli, irradiation

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I’m at the Informex conference in San Francisco this week and so there will likely be if any postings. Once I’m back on Monday Feb 19, I’ll be back to my regular schedule of several postings each day M-F.

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The New York Times had a good article about biotech with a focus on Xoma but it does details the massive amounts of money that have been lost in the biotech sector. Definitely worth a read.

It’s Alive! Meet One of Biotech’s Zombies - New York Times:

Technorati Tags: biotech, biotech companies, Xoma

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According to Bloomberg News, the London Times is reporting (without naming source) that Sanofi-Aventis has decided not to pursue Bristol-Myers Squibb.

Sanofi Halts Takeover Talks With Bristol-Myers, Times Reports

This could be true but I don’;t think it changes the fact that BMS is looking for someone to merge with. Mark my words, before the end of this year, I think a merger for BMS is definitely in the cards. Again, I don’t personally think that approach is sound but think that is most likely what will happen.

Other Sources

Bristol falls, Sanofi rises on report - Yahoo! News

Technorati Tags: Bristol-Myers Squibb, pharma M&A, Sanofi-Aventis

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Seems China has had a problem in the past with their drug approval process. As many as 170,000 approved between 1999-202 drugs may be reviewed. There has been a string of deaths that have been blamed on the corruption of some individuals within the Chinese drug approval system.

China Launches Review of Drug Industry - washingtonpost.com:

Seems Zheng Xiaoyu, formerly director of State Food and Drug Administration (SFDA) in China was fired in 2005 for taking bribes and letting companies circumvent testing procedures and approval processes. Now, drugs approved in China in the time period of will be reviewed. It is good to see China confronting this problem and at least two other deputy director are under investigation.

With China becoming more of a factor in world healthcare it is good to see they are addressing issues to make sure drugs inside China are safe and effective.

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Bloomberg News is reporting that scientist David Ross a former FDA employee, who was one of the players regarding the antibiotic Ketek, is working with Congress to strengthen drug safety rules.

Whistleblowers Help Congress Strengthen U.S. FDA

Along with four other current and former FDA employees they are working with Congress on improving drug safety. I think having some defined process that brings together all potential resources for drug safety definitely needs to be done. However, there needs to be more than just a collection of information and if a new branch of the FDA is created, it may not solve the problem since it would be part of the culture that has created the current circumstances. I’m more in favor of changing the culture within the FDa and get it to focus back on it;s priority of protecting consumers.

I’m all for improving drug safety but think too many times the approach is too stringent or doesn’t address the root cause. Although there have been some high profile cases such as Vioxx and Ketek recently and the FDA really hasn’t done a good job of handling the media, I think that may be changing now that they have a full time Senate confirmed commissioner. I also think too many times there is a knee jerk reaction without thinking through the ever-present “law of unintended consequences”. This is an important issue and one that

If you want to keep up on legislation in Congress regarding pharmaceuticals and the FDA, Mark over at Eye on FDA had a nice posting listing legislation before Congress. I had been meaning to put something together but he beat me to it so I’ll just refer you to his posting.

Technorati Tags: antibiotics, Congress, drug safety, FDA, Ketek, Sanofi-Aventis

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The FDA approved the diet drug Xenical which has only been available by prescription for over the counter distribution. The new name for the lower dose OTC version will be Alli.

FDA Approves Orlistat for Over-the-Counter Use (FDA.gov)

The following Medical News Today article has more information.

FDA Approves Over The Counter Weight Loss Pills (Medical News Today)

I have mixed feelings about this. The article makes clear that this should be used in conjunction with diet and exercise but I think too many people may view it as an easy way to loss weight without any effort on their part. I think it appears to be useful for people in conjunction with diet and exercise and I am all for helping people become healthier. Bit it also seems to play into the American obsession with losing weight without putting forth any effort on their own part. It will be very interesting to see how Roche (the makers of Alli) what kind of advertising they use to promote this drug.

This is the first time the FDA has approved an over-the-conter weight loss drug.

Other Resources
Yahoo! News Search Results for xenical FDA over the counter
xenical FD over the counter - Google News

Google Blog Search: xenical FDA over the counter
IceRocket Blog Search: xenical FDA over the counter

Technorati Tags: Ali, FDA, weight loss, Xenical

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Seems the presidents budget for fiscal 2008 will contain massive cuts in domestic programs to pay for the war in Iraq. Bloomberg is reporting the cuts will be over $78 billion over five years.

Bush Seeks $78 Billion in Health Cuts Over Five Years

This will certainly lead to some interesting discussions in the Democratic controlled congress. Take a look at the article to see what programs will potentially be affected.

Technorati Tags: healthcare

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I found this report from the BBC to be interesting and an example of what I call thinking outside the box. By that I mean approaching a problem from a different perspective than normal.

BBC NEWS | UK | England | London | Anti-MRSA silver pyjamas trialled:

It describes research being done in England with sheets and clothing )pajamas) made with silver in the them to combat methicillin-resistant staphylococcus areus (MRSA) infection. These infections are the so-called superbugs that are resistant to most common antibiotics. Usually these sorts of infections only respond to Vancomycin and if strains develop a resistance to that and then become prevalent, the world could be back to the equivalent time when all we had were sulfa drugs to treat infections.

This approach is interesting since it . It is known that silver can be an effective anti-microbial and if this proves effect could be a wonderful way to prevent infections in hospitals.

I can say that I know first hand how devastating these infections can be as my wife developed a life threatening MRSA infection last summer and was in intensive care for about a week followed by another week in a regular hospital room and eight more weeks of daily IV Vancomycin therapy after that!! THese infections can come on very quickly and are very serious.

I will definitely keep an eye on this and am interested to see if it works. It certainly is a new way of thinking about preventing hospital infections.

Technorati Tags: MRSA, superbugs, silver cloth

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I’ve been busy with other projects recently but am not getting caught up on all the chemistry and science related news from the past few days. One of the important ones was a recent announcement about the government of Thailand breaking patents on Plavix (Sanofi-Aventis and Bristol-Myers Squibb) for heart disease and Efavirenz (Merck) an HIV drug.

FT.com / World / Asia-Pacific - Thai goverment to break drug patents:

This seems to have caught the pharmaceutical industry by surprise. The Thai government says they can not afford the drugs and there are legal processes in place for governments to break patents under World Trade Organization (WTO) rules. There is much conversation about under what circumstances this can take place since the law evidently is unclear and critics are saying that Thailand doesn’t have criteria outlined to determine when this should occur.

I have mixed feelings. I am sympathetic to the cost factor but think the Thai government should have enter into negotiations with the companies first. Also, you need to consider that the Thai government recently was overtaken by a military coup de’etat back in September 2006. So it is unclear how exactly this current government will operate.

I don’t think this will become a trend; I think this particular government may be a an aberration.

Technorati Tags: Thailand

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