Glaxo's Avandia Drama

Yesterday I wrote about how the fallout from a recent study that found Glaxo' Avandia has potential to increase heart attack and death. Yesterday i came out this nice coverage of the Avandia drama at BioHealth Investor, on how the media overdramatized the case. I think this has a potential for the Vioxx/Cox2 case redux. That dramatically changed the modd and behavior of the FDA. FDA's approval rate dramatically declined after that, mostly because of public outcry blaming the regulatory body for approving the drug and well, public's sad mastery of statistics. I am for public disclosure of all information but not mis-information.

Even the author of the Avandia study, Dr. Nissen cautiouned the public, “I do not want our study to lead to a public panic... Patients should not stop taking the drug on the basis of a news report.” in a CBS coverage.

The study found that 0.44% of the 10 thousand people from various Avandia clinical trials developed heart attacks compared to 0 .33% taking placebo, and death resulting from cardiovascular causes was 0.38% in Avandia group compared to 0.19% for the placebo group. After crunching the numbers, the authors came up with the odds ratios that taking Avandia has 1.43 times the odds of developing heart attack and 1.64 of dying (the confidence interval was a little broad). So as you can see the odds of dying and getting heart attack despite being significantly elevated, was still relatively small. All drugs have side effects and elevates risk of developing something. Some of these risks might show up during trials, some won't until the drug is widely used. Hell, I don't have hard data, but I guess French Fries might have similar effect to Avandia.

A lot of people are panicking, a family member asked if it's true that taking Avandia will give him 43% chance of developing heart attack and death. This is serious matter, and I think Avandia patients should discuss with their doctors if taking the drug is still worth the drug's increased risk. But there is no need to panic and stop taking the drug for no reason. I think instead of spreading uncontrolled wildfire, the media might be better off giving the public (and probably capitol hill) statistic 101 refresher before oversimplifying and misinterpreting the facts.

The sad part is that I think this will make the FDA less efficient in performing its duties. No FDA official will want to face congressional hearings or public outcry for his/her head in the future ifor a drug being approved today ended up having have unknown side effects/risk. The Vioxx case have made the FDA slower and being overly conservative in approving drugs. I won't be surprised if in the future the FDA won't approve any new drugs at all because of this fear.

I think the FDA is only a front line gate for drugs. Ultimately it is the patients and physicians' (well and payors, etc.) decision whether a drug's benefit outweighs its risk to be prescribed in case by case basis. I think it is better off that patients and doctors are given the chance to use as much choice of arsenal in fighting diseases and improve quality of life.

Grrh part 2.

Well, My portfolio is rather heavy in biotechnology and Chinese stocks. So as you can imagine the past few days were pretty bad.

Now I am betting that the FDA will be scared to approve any drug that has even the slightest safety problem after the recent Glaxo Avandia bruhaha. Thing has been tough after the Vioxx case, that resulting the FDA approving less drug. Now, I bet the FDA will be scared to approve any drug application, even when the potential benefit may greatly outweigh the risk, unless it has squeaky clean profile. No one wants to be in congressional/senate hearing years from now if a drug approved today ended up having higher risk profile than initially thought.

I was enjoying some nice run with my little portfolio of Asian and Chinese stocks and ETF's. But then my old friend, Alan Greenspan, just had to take the punch bowl away, warning the market that a correction in Chinese market is imminent.

OK maybe now I should start buying gold bullions instead.

Grrrh

I am mad.

I am reading some market updates when i found this article at Marketwatch, it says "India's PT Telekomunikasi Indonesia (TLK : Perusahaan Perseroan (Persero) P.T. Telekom. Ind., 44.88, +0.88, +2.0% ) picked up 2%."

Well, P.T. Telekomunikasi Indonesia, as its name suggests is an Indonesian company, not Indian. Indonesia is about 3000 miles away from India. I just can't believe a Marketwatch reporter missing basic fact.

Well, maybe I am just angry because people are having a lot misconception about Indonesia. I think most people in the West thinks that the country's all jungle and all schools in Indonesia are Madrassas (but what's wrong with madrassas anyway? Yes, some has been misused by some interest group of the violent kind). Or that the whole country was swept by tsunami and all babies are up for adoption by Britney. I seriously think that an orphanage might be better place to grow up in than the Spears household).

OK enough of this random pointless rant.

Champions League Final

Ok getting ready to watch the Champions League final between AC Milan and Liverpool. This is bigger for me than Super bowl or NBA finals for me. I enjoyed 2005 final between featuring the same match-up when down 0-3 Liverpool came back to tie the game in regulation and won it in the shootout after scoreless extra time.

I don't know whom to side. I think Milan plays better football and I like their Brazilian infused Joga-Bonito style better with their 6 Brazilian players. However, I think it's wrong for them to win it all after match fixing the scandal.

Well, I guess I'll just enjoy the football who knows there is gonna be another Peter Crouch unforgettable moment. Like the scissors kick vs. Galatasaray earlier in the tournament (I wonder how the heck he didn't break anything).



Update: a bit disappointed to see Crouch missing from the starting lineup, especially after all he has done to get his team here... but oh well... I hope he gets some minutes.

An Ode to Open Source

OK after I finished setting up my new Vista laptop and got everything going (well almost), my fiancee told me to do something about a 6 yr old desktop collecting dust in a corner. Besides that desktop, we have 4 laptops. So while the old Dell desktop still can be useful for basic stuff, it was too slow and less productive compared to the newer PC's in the house. We wanted to donate it to a school or other non profits at first but lazy me kept procrastinating.

All our PC's in the apartment share one printer and scanner, the old fashioned way, by plugging and replugging cables. I tried turning on Windows' File and Printer Sharing, but then decided that it was too sluggish for the old desktop. I was preparing the PC to be donated to a local charity, when I then decided that I want to check out Linux and that old PC would be the perfect sandbox machine for me. So I downloaded and installed Ubuntu 7.04 (Feisty Fawn) on the machine.

Well, I was very surprised that the installation was pretty painless, considering my recent bout with Vista. Ubuntu recognized almost all of my hardware devices during installation and I was up and running within an hour or so. I was surprised that the old clunker now feels faster than even my newer PCs running windows. Applications launch and close in a blink and booting up takes only less than a minute. I set up file and print sharing using Samba, and it actually worked pretty seamlessly with my Ubuntu/Linux, XP and Vista mixed environment and felt much faster than Windows file and print sharing. I even went out and upgraded the hard drive, and make it a backup file server for our laptops.

I also got a chance to play around with OpenOffice and was quite pleased to learn that it is pretty compatible with MS Office documents and at a glance, I would think that for most users OpenOffice can be a good alternative for MS Office without the $400 price tag. I can pretty much do almost all the daily task I normally do in Windows with Ubuntu (at much lower cost). Well yeah, I wish that I can play games like World of Warcraft on it (actually some people managed to do it with some emulators, I tried wine but decided it might not worth the effort considering I have other Windows PC's at home).

The bottom line is I am blown away by the fact that all these quality softwares are available for free, built by an army of volunteer developers working gratis, collaborating from all corners of the world. I think sooner or later, Microsoft and others might have to rethink their business and revenue model. Linux has gained good acceptance in the enterprise and development world, but it was mostly in the back end, running database and web servers. But now I can see that some savvy mainstream consumer and business users may use Linux like Ubuntu in the front end too, running daily task like web browsing, email, word processing, spreadsheet, etc. using free open source applications llike Firefox, OpenOffice, etc. Actually Dell is planning to start shipping PC's preloaded with Ubuntu. I will be closely watching this development.

We have seen how the internet and especially open source community developed products disrupted many traditional business models. For example, Wikipedia has managed to challenge Britannica's domination in the encyclopedia world. Web 2.0 innovations that among others include blogs and blog aggregators like Seeking Alpha and wiki based community like ValueWiki are starting to challenge the business model of traditional Sell-Side Wall Street Research.

Well, I guess the world is getting flat after all.

Wrestling with Vista and my New Laptop

Finally my new laptop finally arrived. I was like a kid, quickly opening the box and plastic wrappers. But the joy didn't last too long. My new laptop comes with this little thing called Windows Vista.

For the most part, Vista is a looks cool, but I still need to get used to the new interface. I ended up uninstalling many of the preloaded software, most of them useless but launches automatically at startup, and turning off most of Vista's nifty cosmetic features just because it took me too long to do anything (mostly boot, reboot and launch applications). I am trying to figure out if there's a way to turn off or at least reduce the security messages asking me permission to launch, install or have access to anything.

For the most part, the migration from my old computer has been pretty decent. I managed to reinstall most software I had in my old computer, well it would be nicer if I could reboot less between installations. Yes, my IM buddies, that's why I logged in and out every 2 minutes or so. I was happy that it took me only a few seconds to get my old outlook 2003 data file to work with Outlook 2006. Some software, like Adobe Acrobat 7 kept telling me that I need administrator rights to install it, I thought I was the master of the universe.

It is more challenging to get my hardware to work properly with Vista (e.g. printers and scanner). I guess the trick is just to install the driver without its accompanying software (like HP's officejet utility/manager).

Anyway I expect to fight little fires here and there with my new computer for now. Maybe I should have listened to Chris Pirillo and get XP with my new laptop. Here's Chris Pirillo ranting about his Vista experience... I can't think of anything else to add. Well, I didn't exactly have a great experience with Vista so far, but my nightmare's not as bad as Chris described.