I’ve always been a big fan of Nova and it is on my season pass on my tivo. My only disappointment was how it ended and I won’t ruin it for anyone who hasn’t seen it but thought they could have done more. Then I find out there is going to be another follow on called “Absolute Zero: The Race for Absolute Zero”. I’m hoping my disappointment will be cured with this next episode. It is set to air on Jan 15 at 8 pm at least according to the PBS website.

I highly recommend this Nova episode for anyone with even a passing interest in science. They did an excellent job of covering the history of the study of cold and even though I’ve been a life long scientists, I still learned something, especially about the first use of “air conditioning”.

I am constantly amazed at how little knowledge some of my fellow scientist have of the history of science Many do not seem to be at all interested in the historical aspects of science but I think you can learn a lot about science itself and how it interfaces with society by understanding where we come from. A great example of the history of science not being taught in the area of chemistry (my special area of interest) is the program “Forgotten Genius - Percy Julian“. Although I have taken a course on the history of chemistry and read a couple of books about the history of chemistry and had never heard of Percy Julian. You can also view this program online for free and read a lot of other information on this black chemist and his accomplishments.

I always enjoy these sort of science and history related shows and this reminds me a lot of the Connections series with James Burke that the BBC did several years ago. I really wish TLC of Discover would re-air those episodes. You can still get them on DVD but they are expensive; $149 for 5 DVD ten programs. Connections 2 is also available for the same cost but it doesn’t look like Connections 3 is available.

Technorati Tags: absolute zero

FDA

‘Accelerated Enforcement’ Now Against Unapproved Drugs: FDA will be accelerating enforcing regulations against unapproved and unregulated drugs and are having weekly meetings to discuss priorities.
Killing the Goose That Lays the Golden Drugs: An article stating that there is a need to balance drug safety with access to new therapies.
Press Release: Sanofi-Aventis Announces Update To U.S. Prescribing Information For Ketek - FierceBiotech: More on the Ketek fiasco.
PharmaLive: FDA Announces Label and Indication Changes for the Antibiotic Ketek
Sanofi shares slide as FDA delays Acomplia–again - FierceBiotech: More delays for Acomplia in the US; decision to be made by July.
FDA deny drug application from Advancis - Washington Business Journal: Another antibiotic has hit a snag; Advancis NDA is said to be incomplete and unable to be approved.
US warns Abraxis BioScience about plant problems | Health | Reuters
Abraxis Bioscience, Inc., Warning Letter: From the FDA website.

Government and Congress

GAO warns of Medicare drug overcharging - Boston.com: The GAO is worried about schemes to overcharge the US government for the Medicare Part D Prescription Benefit. The basis is that the complex set of rules makes it difficult to verify the accuracy of drug prices.
Biotech trade group warns of price controls - MarketWatch: The leader of BIO warned against the HHS being able to negotiate drug prices and calls them defacto price controls.
Democrats plan bill for generic biologics - washingtonpost.com: This could be big and I’ve posted before about biogenerics.
Generic Biotech Drugs Could Save $71B - washingtonpost.com: Another article on biogenerics and what impact it may have.
Lawmakers unveil bill to create clear pathway for generic biologic drugs
Newsvine - Texas Gov., Lawmakers in Vaccine Dispute: more about the Gardasil vaccine being required by the govenor for girls in Texas.
Pfizer’s AIDS drug to get faster review - Yahoo! Finance

Pharma News

PharmaLive: Lovenox Patent Infringement Suit Decided Against Sanofi-Aventis
PharmaLive: New Campaign Champions Changes in Medical Prescribing to End Conflicts of Interest
Bayer to file for Nexavar approval for liver cancer - Boston.com: I know folks at Onyx and am glad to see this drug proceeding so well.
Thailand threatens to produce more copycat drugs | Science | Reuters
Thailand plans to break patents on 14 drugs: firms - Yahoo! News
British pharmacy pilots over-the-counter Viagra - International Herald Tribune: Brings new meaning to the question, What’s Up? PharmaLive: Merck Settles Tax Dispute with Internal Revenue Service
Eli Lilly Regains Leaked Papers - washingtonpost.com: A judge orders papers related to Zyprexa to be returned to Eli illy.
PharmaLive: Telik Announces Corporate Restructuring: More lay-offs.
Ariad says close to cancer drug partnership deal | Health | Reuters
PharmaLive: Ranbaxy: Press Statement: Federal officals conducted a suprise search of Ranbaxy’s NJ offices.

Biofuels

Philadelphia Inquirer | 02/12/2007 | Oil firms speak up on alternative fuels: Major oil companies now want a seat at the table for discussing alternative fuels.
New theme heard at oil gathering - Los Angeles Times: Another article on big oil and their interest now in biofuels.
Big Oil says biofuels won’t meet U.S. energy demands - Feb. 15, 2007: more on the big oil views of biofuels.

Biotech

United Press International - Health Business - Seattle Genetics’ drugs get orphan status: I know people at Seattle Genetics and think they have a good business model and am glad to see these products get orphan drug status.
Wired News: Pharm Animals Crank Out Drugs: Another article on pharming, using animals to produce drugs. Covers GTC Biotherapeutics who I’ve mentioned before here and here.
Biotech posts fastest growth globally: Article on the double digit growth (35%) in India’s biotech industry.
Hawaii has more biotech bills - Pacific Business News (Honolulu): The Hawai’i state government had 44 bills before it relating to biotech in 2006.

Other
Refusing to share samples ‘may cause a vaccine delay’-News-World-Asia-TimesOnline: GSK has attacked the Indonesian government for refusing to supply bird flu samples to other companies for research to develop vaccines.
Technology Review: Discovering Drugs with Bubbles: I’ll share my views on this in a later post.
I’ll try to comment on some of these in more detail later this week if I can get some spare time.

Seems that biotech crops are big there and second only to pineapple in terms of dollars generated. The genetically modified seed business is valued at over $70 million. I also know that the industry employes about 2,000 jobs many of which are well paid and they contribute over $7 million in taxes to the local government.

Biotech now second only to pineapple - Pacific Business News (Honolulu)
I have mixed feelings about GM crops in Hawaii. I have posted about this before. While I am a supporter of GMO and think it can greatly benefit person-kind, I also know how fragile small isolated environments such as the Hawaiian Islands can be. I also understand and respect those who have concerns and think those need to be adequately addressed.
Technorati Tags: biotech crops, Hawaii

For those of you not familiar with Tamiflu, here is the structure.

And then here is the reaction that forms four sterocenters and three carbon-carbon bonds. It is asymmetric and catalyzed by a proline derivative. [Control of four stereocentres in a triple cascade organocatalytic reaction, Dieter Enders, et. al., Nature 441, 861 - 863 (15 Jun 2006)].

What is amazing to me is that the author of the C&EN review didn’t comment on how related these two items are. I did not read the Nature article and maybe it does mention the possibility of using this reaction for this specific compound. I’ve not sat down to analyze what would be needed and am not familiar enough with this reaction to know what groups it might tolerate without affecting the overall reaction, but it certainly is a fascinating idea.

Technorati Tags: Chemical & Engineering News, Tamiflu

This article looks at a variety of reaction solvents; DMSO, DMF, NMP, DMAc, TMU, DMI, THF, 1,4-dioxane, diglyme, and acetonitrile and how they perform with extraction solvents such as toluene, EtOAc, iPrOAC, 1-chlorobtuane and heptane in aqueous solutions such as water and salt water.

The article is well wroth reading and noting for future use.

This is in the first issue of the journal for this year and is available to everyone. Typically for some ACS journals the first issue of the year is free and available to everyone.

Removal of Reaction Solvent by Extractive Workup: Survey of Water and Solvent Co-extraction in Various Systems (pdf) or alternative html

Here is the Supporting Info.

Technorati Tags: extraction solvents, solvents

This article looks at a variety of reaction solvents; DMSO, DMF, NMP, DMAc, TMU, DMI, THF, 1,4-dioxane, diglyme, and acetonitrile and how they perform with extraction solvents such as toluene, EtOAc, iPrOAC, 1-chlorobtuane and heptane in aqueous solutions such as water and salt water.

The article is well wroth reading and noting for future use.

This is in the first issue of the journal for this year and is available to everyone. Typically for some ACS journals the first issue of the year is free and available to everyone.

Removal of Reaction Solvent by Extractive Workup: Survey of Water and Solvent Co-extraction in Various Systems (pdf) or alternative html

Here is the Supporting Info.

Technorati Tags: extraction solvents, solvents

Solvent Applications of 2-Methyltetrahydrofuran in Organometallic and Biphasic Reactions (abstract)
Aycock, D.F. Org. Process Res. Dev., 11, 1, 156 - 159, 2007, 10.1021/op060155c

Luckily for most, this is in the first issue of the year and is avaiable to everyone. Typically, it is for subscribers only. Free full aticle link Solvent Applications of 2-Methyltetrahydrofuran in Organometallic and Biphasic Reactions (pdf) or an alternate html.

I should point out though that the article is by David F. Aycock who works for Penn Speciality Chemicals and is a primary supplier of MeTHF.

There are several factors that make it such an interesting solvent.

• Unlike THF, it is not completely water miscible and does not readily form emulsions or rag layers.
• Its water solubility is low, 4 g per 100 g water.
• Moderate boiling point of 65.7 °C.
• Available from readily renewable resources (2-furaldehyde from corncobs).
• Forms azetropes with several solvents including water (10.6% water).
• Three times more stable than THF to 5N HCl at 60 °C.
• About the sme tendency as THF to form peroxides.
• Works well for forming Grignard reagents. Can form much more concentrated solutions than is possible with THF.
• Is a suitable replacement for dichloromethane.
• Effective for extracting polar alcohols such as 2-propanol from water. Two extractions with equal volumes extracted 94% of 2-propanol from water. Only 68% was removed using toluene.

On the downside though, this solvent is significantly more expensive than THF. Penn makes the argument though that you don’t have to use an extraction solvent that you must use with THF or that you can make more concentrated solutions of Grignard and so therefore use less solvent.

It is a good article and well worth reading and noting for future use for all chemists.

You can also view other articles in this free issue of Org. Proc Res. & Dev.

Other Resources

Products”>Penn Specialty Chemical Inc. > Products MeTHF
Methyltetrahydrofuran: How to Recover and Dry MeTHF Batchwise (pdf)
Penn Specialty Chemicals Inc.
ChemExper - catalog of chemical suppliers, physical characteristics and search engine (methyltetrahydrofuran)

Technorati Tags: MeTHF, PennSpeciality Chemicals, 2-methyltetrahydrofuran

This article from mid-Dec from the BBC News gives some idea of the extent of the problem.

BBC NEWS | Science/Nature | US scientists reject interference

The statement they report on was signed by over 10,000 scientist from a wide variety of the sciences and included 52 Noble prize winners. I am hopeful that with the last elections, their will again be some oversight and sanity brought back to the topic of using science to help Americans and the world as a whole.

I have mentioned Chris Mooney before and his book The Republican War on Science” (Chris Mooney). He also has a great blog The Intersection. I highly recommend both.

Other Resources
A to Z Guide to Political Interference in Science

Dear Kitty. Some blog :: USA: voice of science stifled in Bush administration :: December :: 2006
Dear Kitty. Some blog :: USA: Bush administration gags scientists :: December :: 2006
AlterNet: Junking Science (interview with Chris Mooney)
New Statesman - Right and wrong (review of Republican War on Science)
Spot-On: Christopher Brauchli: Closed Doors, Closed Minds, Closed Science

Lettuce May Have Caused Taco Bell E. Coli Outbreak

Now the likely culprit is lettuce. Cheese has been ruled out because all the cheese use is pasteurized and therefore it is unlikely to be the source of the contamination.

Being as there is no clear answer, this may lead to lingering problems for Taco Bell.

Technorati Tags: e coli, food safety, Taco Bell

Process Engineering | R&D takes the fast track | Chemical Processing

Many of these articles focus on automated systems working overnight and lowering labor costs. While I don’t dispute that, I think there needs to be more thought put into what you can learn from this and how it can be used effectively. In some ways, it reminds me of when desktop publishing first came to personal computers and people used dozens of fonts, formatting and colors simply because they were could. After a while, people realized that using these indiscriminately just because you could, did not result in better communication of ideas. The same holds true with automated high throughput experimentation. Just because you can perform thousands of experiments in a week doesn’t mean you should or that you are getting the best answer. Doing 1,000 reactions in two weeks isn’t as productive as 200 carefully chosen and designed experiments done in three days.

Here are my basic points.

1. There is a need to work smarter not faster.
2. Better use needs to be made of the data generated.

First, I am a firm believer in spending time up front thinking about the problem before starting to do experimentation. This avoids the “Ready, Fire Aim” mentality that seems to be so pervasive in some R&D departments. I understand this tendency and fell into that trap myself early in my career. However, taking the time to think through the possible variables that could have an impact is a worthwhile exercise.

One of the most important aspects of this thinking ahead before performing experiments involves, design of experiments. This is a way of running reactions to get the greatest amount of information from the smallest number of experiments. While it may not be as imperative as it was in the past to run a small number of experiments, it still is valuable to run the best set of experiments possible. Using advanced software, it is possible to get the best set of experiments regardless of how many variables there may be or whether or not those variables are discrete in nature (such as which catalyst to use) or non-continueous (where only a given set of of conditions can be ran). I would point out that QD Information Services has the capability to design experiments specifically for your situation.

The second point involves better use of the data generated. I have come across too many situations where the approach was to run hundred or thousands of experiments and then sort those in a spreadsheet and go forward with the top one or two choices. At a major process development conference last year, one of the top ten pharmaceutical process development directors made a point of listing all the reactions they had run to find the “best results”. At the end I stood up and asked what they did with the data and got the reply that basically they had solved the problem and moved on to the next problem.

The problems with this approach is it does not take advantage of all the experiments that have been performed. Why invest the amount of time into setting up that many experiments and collect that much data and not try to get as much information as possible out of it? Also, how do you know you have found the “best answer”? Too many times, it is settling for what is acceptable instead of what is best. This leads to openings for your competitors to come in, find the true optimum and possibly patenting that and preventing you from using the best possible conditions.

The best approach is to design the experiments up front but even if that doesn’t occur it is possible to do data mining and possibly find meaning in the data. It continues to amaze me the number of large and mid-sized pharmaceutical companies that don’t take advantage of all the data generated to get the most out of their investment. And too many times, the answer I get is they don’t have time to do more and must move on to the next problem. I often offer to do this data mining for them but they still fail to see any value in this activity. To me, I think this is poor decision making and not getting the most out of your investment and it could come back to haunt you.

I just want to remind folks that QD Information Services can help in these sorts of situation so if you have a need for this, please feel free to contact me and I’ll help you understand how you can get the most out of your data.

Technorati Tags: data mining, design of experiments, high throughput

R&D’s Dirty Little Secret

This article by Robin Y. Smith comments on the elephant in the room for most pharmaceutical companies as well as fine chemicals companies in R&D. The problem is the incomplete and sloppy notebooks. This is the elephant in the room that no one wants to talk about.

He found, based on auditing 10 years of lab notebooks from a top 10 pharmaceutical company, that 15% of the pages had major problems such as being illegible, incomplete, or had some other error meaning the experiment could not be reproduced.

In some of the worst cases, 60% of the pages were deemed not reproducible and this did not count vague phrases such as “worked up in the usual fashion”. If there was ever an area in R&D that could is ripe for improvement, this is it.

Cases of scientists being judged on the number of notebooks filled leading to “dry labbing”. This is where lab notebooks are padded with many planned experiments which are never carried out. Just looking at the number of notebooks filled these scientists appear to be very productive.

I’ve always been frustrated when trying to find info in others lab notebooks. Lack of table of experiments in the front resulting in having to flip through the notebook until you find the right result. Not knowing which of dozens of lab notebooks contains the information you need. Experimental results such as chromatograms or NMR printouts not being in the notebook or even worse, being in another 3 ring notebook that isn’t identified by anything other than a volume number. I have spent too much time trying to find information rather than analyzing and coming up with new experiments.

The problem is at its worst in discovery or med chem groups but I will note that even in most process development groups it is better but still not great.

The article doesn’t comment on stats for use of phrases such as “typical work-up procedure”, “standard procedure”, etc. without referencing some other document or lab notebook page. As a process development chemist, I always found this sort of documentation mind boggling. I had one case were I was repeating a drug discovery process on a small scale to become familiar with the process and at one point encounter a horrible emulsion. I went to the discovery chemist and asked if this is what he saw and if so, what did he do about it. He said yes, he saw that too and he just left it to sit overnight until it separated. This was NOT noted in his lab notebook! Needless to say, this required a lot of work in process development to get a process that would work on even a 22L scale.

The other complaint I have is even when a work-up procedure it listed, most of the time in my experience, the procedure did not list volumes of solvent or aqueous washes used. In another case, it said the organic layer was washed repeatedly with water. I found out that it was washed 15 times with huge amounts of water each time!!! None of that was documented. When I asked the chemist, they said all these washes with that large of volume of water was indeed required to get rid of some inorganic salts. Ends up, using equal volumes and doing 3 washes worked fine.

All of these are huge problems and I do indeed think that electronic notebooks are needed. I’d like to see them used much more widely than they are currently and think this could go a long way towards increasing R&D productivity.

I should point out that the author, Robin Y. Smith is Vice President of Product Strategy at Symyx Technologies and they make software for electronic notebooks.

Technorati Tags: documentation, lab notebooks, R&D productivity

This was published in the Proc Nat Acad Sci. and here is the abstract. The article is Estimating the diversity of dinosaurs (pdf).

Technorati Tags: dinosaur, paleontology

Democrats Plan to Revive Stem Cell Bill - washingtonpost.com:

I really think there are other things I’d like to see at the top of congresses agenda. While I think this is important, I doubt there would be enough votes in congress to override a certain presidential veto. The president has already veto it once and there is no reason whatsoever to expect it not to happen again. However, there could be consideration beyond just getting the bill passed as is common in politics. This may be a way for Democrats to benefit from the debate and ensuing media attention after a second veto and would certainly bring the issue to the forefront for the presidential elections in 2008.

My impression is that the majority of people think there should be funding for such research. It brings to my mind the times when the church and other groups felt that cutting up human bodies to understand the various system such the the respiratory system or the circulatory system was unconscionable and an abomination. I don’t know of anyone today who would say that was wrong given the enormous impact of such knowledge on medicine today.

I truly hope stem cell research can be funded and continued in order to keep the US at the forefront for such research.

Technorati Tags: stem cells

Chemist to lead study of Titan’s moon - Yahoo! News

This five year $2.5 million dollar grant from the National Science Foundation will use the NASA infrared telescope located on Mauna Kea on the big island of Hawaii. The hope is that by studying the atmosphere of Titan insight may be gather about earth’s early atmosphere. One of the major issue to be investigated is to see how hydrocarbons in the atmosphere absorb damaging ultraviolet radiation from the sun and preserve some compounds that are may play a role in the early development of molecules essential to life.

The first workshop is scheduled for February of 2007.

Other Resources

• Reaction Dynamics, University of Hawaii at Manoa
• Titanworkshop 2007
• SPACE.com — Titan: A World that Never Grew Up

Technorati Tags: chemist, NASA, space, Titan

Biotech’s Beef

The main complaint is that they lack some technical skills and have no understanding of the concepts of quality control and regulatory issues. I personally think there are several reasons for this and I’ll discuss each of them below.

Let’s first talk about colleges. There are two major reasons that colleges and universities don’t do a better job at preparing students for jobs in technical fields such as biotech. In regard to technical skills, many colleges do not have the sophisticated equipment needed to train their students. Money is a constant problem and my personal experience is that the equipment in colleges and universities is sometimes decades out of date. This is especially true for expensive equipment. When I was studying as an undergraduate in the early 1980’s, we didn’t even have a working mass spectrometer to use in the advanced analytical lab. We barely had an NMR (60 MHz continuous wave). When I went to graduate studies at a large state university known for its chemistry program, the situation was much better, but still many of the day-to-day instruments such as the gas chromatography equipment was from the 1970’s, although we did have access to high filed FT-NMR.

The second reason that colleges and universities don’t do a better job has to do with make up of those teaching, i.e. the professors. My experience is that many of them have never spent anytime in industry so how can they teach what they don’t know or understand themselves? My personal experience was that in tens years of college, none of the science professors I took a class from or who I knew had ever held a job in industry. They all had graduated, gone on to a post-doc position, and eventually worked in a college or university. It is practically impossible to talk about topics such as the regulatory environment or quality control without any experience in those areas.

In some cases it goes beyond jut not knowing; there are some who seem to have an attitude of contempt for those in industry who may express a desire to teach. Many professors have a certain disdain for industry and those outside their small cliche. As an example, a small community college in my area had an opening for a chemistry professor. I applied and was told that I they had “grave concerns” about my teaching abilities since I hadn’t “taught” for over 14 years. I replied that although I had not taught in a college or university since my graduate school days, I did a lot of teaching in my community, my church, my corporate life and even taught paid training courses in my own consulting business. This didn’t count according to them. They seemed to feel that the lack of teaching experience in the exact environment of a college outweighed the practical, real world experiences I could bring from industry. After several months of not hearing form them, I called and was told they had forgotten about my application and would send me a notice in the mail soon. A couple of days later, I received a very short rejection notice.

All though universities and colleges are to blame for much, some of that blame also lies with biotechs themselves. In many cases, they seem to want fully trained robots that they employ without difficulty. One of the first things cut in down times at companies are the training budgets. Also, there is much talk about employee loyalty and that if they train someone, they will leave for another job before they benefit from the training. This may be true, but, when this is brought up to me, I always ask when was the last time they had a lay-off due to a temporary set back. Invariably within the last 16 months or so they have had some sort of major “restructuring” which included people losing their jobs. Today, companies that complain about employee loyalty but then have lay-offs every time there is a down turn, have no room to complain. To make matters those who have to find other jobs,find upper management at their former company gets rewarded for getting rid of employees?!

Then end result of the short-term short-sightedness of many companies is that the employees are over-worked and pay doesn’t keep up with the increased responsibilities. The motto of corporations today seems to be” do more with less for less”. This means that those workers don’t have the chance to work as an adjunct professor at their local college or university (see my ideas for improving this situation below).

Here are a few of my ideas for improving the situation.

1. Allow industry folks to have a sabbatical to teach in a local college. This could be for just a portion of a semester or quarter; maybe three or four weeks.
2. Industry should encourage colleges to hire adjunct industry faculty (see #1 above). They could earmark money for equipment and then set up a schedule for them to have access to that equipment. At a former university I attended this was done successfully. The company helped purchase a new high-field NMR and in return, they were given one day a week full access to the machine. Then they also did not have to worry about routine maintenance. That was taken care of by the university.
3. Industry needs to set up and effectively run programs to give students industrial experience. This is more than just allowing an intern to flounder for 6 weeks in one of their labs. THere needs to be a culture of showing students what the industry is about if industry is serious about solving this problem.
4. Expose college faculty to industrial positions. Encourage industry to accept professors during their sabbatical to learn about the industry and the various roles needed. This also means industry has to be willing to give this sort of experience to professors.

I am hopeful that the situation can be improved, but it requires more than just talking from both sides. There is a need to implement these sorts of programs in order to keep America competitive in an increasing technological society.

Technorati Tags: science education

• ScienceDaily: Second-generation Antipsychotic Medications Appear To Offer Little Advantage Over Older Drugs
• Newer Schizophrenia Drugs May Be No Better - Yahoo! News

Both these news stories refer to a recent article in the October issue of the Archives of General Psychiatry which showed that after a year, there was no significant difference between those on older medications (118 patients) from those on newer medications (109 patients). iI was based on a quality of life score and after a year the group on the older medications were 53.2 and with the newer medications was 51.3.

Now granted, the number of patients is small but the results seem to indicate that older cheaper medications could be used in some cases. The thing I think that always needs to be kept in mind is that the results vary with individual patients and this is the reason I have reservations about health plans that try to “encourage” patients to use older medications when studies such as this come out. I understand the need to have access to affordable drugs, but i also firmly believe the decision on what to prescribe should be between the patient and their doctor. I understand the need for a preferred formulary, but think that the hurdles put in place up to prevent the use of newer mediations in some cases is detrimental to the patients health. If a patient tries the first generation drug and it either does not work effectively for them or has side effects, then there should be an easy way for them to get access to the second generation drugs. I some cases, the health insurer may refuse to pay for any costs of these newer drugs. While I think paying a larger co-pay is reasonable, not covering the drug at all is not.

Technorati Tags: antipsychotic drugs, schizophrenia

New drug provides effective defence against bird flu

The above headline is misleading since the work has only been done in vitro and not in patients. I don’t have access to the actual article so I can’t comment on the amino acid sequence.

The peptide seems to prevent viruses from entering the cell and the survival rate for the animal models was 100%. While this is promising, there have been many cases of drugs showing excellent activity in animal models but never working in humans. It will be interesting to see if this develops and goes beyond the preclinical stage. Since this work comes from the University of Wisconsin-Madison, it would take a deal with a pharmaceutical or biotech company before it moves to the next stage.

Sources

Abstract: INHIBITION OF INFLUENZA VIRUS INFECTION BY A NOVEL ANTIVIRAL PEPTIDE THAT TARGETS VIRAL ATTACHMENT TO CELLS — Jones et al., — The Journal of Virology

Technorati Tags: avian flu, bird flu, antiviral, virology

United Press International - Health Business - Analysis: FDA comes up short on nanotech:

The above UPI report was released before the FDA meeting mentioned above. This paragraph caught my attention.

Taylor noted that the FDA’s budget would have to be increased by 50 percent to bring it up to its 1996 level. And the agency’s budget for next year won’t improve without action by Congress. President Bush’s 2007 proposed budget will increase the gap between responsibilities and capacity to 56 percent.

Given how important the FDA is (they oversee 25% of the gross national product) and how much work they have to do an increasing budget gap is cause for alarm. Especially in light of the recent rash of problems with spinach and lettuce which seems to indicate that there may not be enough oversight in this area. Add to this trying to keep up with the rapid advances in many areas particularly nanotechnology and you have a recipe for disaster.

There are at least 320 products using nanotechnology already on the market although many of these fall outside the purview of the FDA and about 200 products that would fall under the FDA’s rules are under development.

This is another example of science leading public policy when it comes to cutting edge technologies. I have some experience in this regard when I worked for a company developing polymer based drugs and educating the FDA on how the polymers were characterized. We had to educate some FDA folks as to what the analytical methods were we were using and how the technology worked and why we were using as well as other methods we tried that may not have worked and why they didn’t work.

FDA told to watch nanotech products for risks - Yahoo! News

The above story focuses on the fact that the FDA is ill equipped to deal with nantech products and the possible safety questions. The FDA has created an internal task force to look into nanotech and should have a report out in about nine months (mid-summer 2007). While I applaud them doing this, it seems to be quite late to the party. Nanotechnology has been popular for some time now and many products have been developed based on it. As quick search of Google news archive on nanotechnology shows articles back to March 1991.

A quick search for nanotechnology in Google trends shows searches for it being fairly flat but the really interesting fact to note is that the US does not even appear in the top 10 cities searching for this term. india occupies 6 of the top ten cities

Looking at the trends by country is even more revealing.

Another interesting tidbit is that Iran is number two for searching for the term nanotechnology. The US is down at the number 8 position. I’m not sure what to make of this but it is interesting.

Some other news stories:

• FDA gets mixed advice on nanotechnology
• Experts give FDA advice for regulating nanotechnology
• Nanotechnology: It’s Knocking on FDA’s Door

Other Resources

• FDA web page on Nanotechnology
• FDA nanotechnology - Yahoo! Search Results
• FDA nanotechnology - Google Search

• Yahoo! News Search Results for fda nanotechnology
• FDA nanotechnology - Google News

Technorati Tags: FDA, Google Trends, nanotechnology

Test to predict response to chemotherapy drug | Top News | Reuters.com

This is exciting news. Basically, people with lung cancer that express a gene called ERCC1 will likely not respond to cisplatin. For these patients, other chemotherapy should be considered. While not proven yet in large studies, this is interesting and might in the future allow oncologists to select the proper treatment based on genetic testing. Since chemotherapy can have devastating side effects, it is important to get a treatment that has the highest probability of success for a given patient. If you are one of those who would not respond to a given drug, regardless of how effective it is in the given population, you would want to know that before going through a treatment with nasty side effects that won’t work for you. The fact that 75% of people respond doesn’t do you any good if you are in the 25% group. I also think that until recently there seemed to be much more emphasis on finding genes that indicated a person would respond to treatment rather than identifying those who would not respond. I think both are important and in the case of oncology identifying those who would not respond is very important to avoid going through a treatment that causes serious side effects but with no really benefit.

Another example is the HER2 and Herceptin. Women with early breast cancer who have higher levels of HER2 are at significant increase risk of the disease recurring and worst prognosis. However, these very patients respond quite well to treatment with Herceptin. This test is routinely used now for women with breast cancer.

I see this as the future of personalized medicine and not the process of making a specific compound for an individual. Finding out who will and who will not respond to a given treatment will be of tremendous importance to medicine in the 21st century.

Other Sources

• HER2/neu - Wikipedia, the free encyclopedia
• NEJM — HER2 and Responsiveness of Breast Cancer to Adjuvant Chemotherapy
• Adjuvant Trastuzumab: A Milestone in the Treatment of HER-2-Positive Early Breast Cancer — Baselga et al. 11 (Supplement 1): 4 — The Oncologist
• Low ERCC1 Expression Correlates with Prolonged Survival after Cisplatin plus Gemcitabine
• Chemotherapy in Non-Small Cell Lung Cancer — Lord et al. 8 (7): 2286 — Clinical Cancer Research

Search Results

• her2 - Yahoo! Search Results
• her2 - Google Search
• ERCC1 - Google Search
• ERCC1 - Yahoo! Search Results

Technorati Tags: chemotherapy, cisplatin, genetic testing, Herceptin, personalized medicine, trastuzumab

CBS News recently had a good article about this.

Home Genetic Tests For Disease - CBS News

One of the problems with these mail-in testing is that, in the vast majority of cases, there is no counseling involved. What about the situation where a woman has sent in a DNA testing for breast cancer and the results come back that she has the gene in question. What does this mean to her? Does that mean she will definitely develop breast cancer? All of these are sure to be though about and without any access to genetic counseling how are they to get answers. Hopefully, most would turn to their primary care physician but some studies indicate they aren’t informed on what these various genetic testing results mean.

Seems that in some cases, these are like the old snake oil salesmen. They claim to test for all sorts of things but don’t disclose the limitations. There is also the worry of counseling if the results are potentially devastating. THen there is the fact that this industry is largely unregulated.

I think this area will be one that sees a dramatic increase in use in the next few years but like any tool, it needs to be used correctly. I can’t say, based on what I know now, that I think the mail order genetic testing is worth the cost, both monetary and psychological. This is another case where science is far ahead of public policy.

Other Resources

Genetic testing - Wikipedia, the free encyclopedia
DNAPolicy
Talk to Your Doctor or Healthcare Practitioner About Home Genetic Tests

Technorati Tags: genetic testing

Click here for a larger image.

The best part was the class was taught in New Mexico at Ghost Ranch where the quarry was discovered (you can see photos of the are here).

Click here for a larger image.

The above photo is by UGAclint from his flickr account. This photo shows that at Ghost Ranch you can view a very large portion of the earth’s history as seen through the rock layers.

So I was very interested to read this recent article concerning some new developments with this very old dinosaur.

Myth Busted: Dinosaur Not a Cannibal - Yahoo! News

One of the famous fossils from there was one that distinctly looks like there are bones of a small dinosuar which looks like Coelophysis inside the abdomen of another large adult dinosaur. This is currently at the American Museum of Natural History and here is a photo of it. I have seen this one as well as another in the Ruth Hall Museum of Paleontology at Ghost Ranch.

Click here for a larger image.

Seems the bones inside the adult Coelophysis are NOT a infant Coelophysis but another small crocodilian species that lived during the same time period (early Triassic). So Coelophysis was NOT a cannibal! It’s too ad this happenedafter Ned Colbert passed away.

Here is a link to the abstract of the article from Biology Letters.

Prey choice and cannibalistic behaviour in the theropod Coelophysis

Here is the Edwin Colbert biography from Wikipedia.

Other Resources

“The Little Dinosaurs of Ghost Ranch” (Edwin Harris Colbert)

“Digging into the Past” (Edwin Harris Colbert): great autobiography of Ned’s early life.
“Great Dinosaur Hunters and Their Discoveries” (Edwin H. Colbert)
Coelophysis- Enchanted Learning Software

Technorati Tags: Coelophysis, dinosaur, Ned Colbert, paleontology

‘Pharm’ goats give birth to new drugs - Sunday Times - Times Online

The drug being produced is ATryn, an anti-clotting drug used to treat patients with hereditary antithrombin deficiency (HAD). This makes the patients vulnerable to deep-vein thrombosis. The drug is being developed by a US company called GTC Biotherapeutics.

There is also mentioned another company developing the drug Rhucin for treatment of angioedema (swelling of soft tissue). This is being developed by the Dutch company Pharming.

It is great to note that these life-savings drugs are being approved. I would note that this really only applies to biologics. I can’t see small molecules being produced in this way anytime in the near future.

Other resources

• Transgenic Animals
• Transgenic animal - Wikipedia, the free encyclopedia
• GlaxoSmithKline: The role of transgenic animals in biomedical research
• Public Perception of Transgenic Animals (pdf)
• Barnyard 101: An Introduction to Transgenic Farm Animals

Technorati Tags: ATryn, GTC Biotherapeutics, pharming, Rhucin, transgenic animals

• Stem Cells
• Drug Pricing
• Global Climate Changes
• Alternative Fuels
• Drug Safety
• Teaching Evolution

I’m sure there are many more but these are the ones that came to mind that relate to issues I discuss here.

I am disturbed by the observation I’ve made that it seems that those who speak out loudest and most often are “right”. It seems many people don’t want to stop and think and just accept whatever they hear. Also, more and more, neither side is really interested in truly listening and hearing what the other side is saying. They are only concerned with being the loudest and getting heard as often as possible.

I think major media contributes to this problem. They want short, concise, black and white views put forth that fit into the 2-3 minutes they allot to each issue. This contributes to everyone speaking in sound bites and no real meat being added to the bones of the issue. Other than a few non-major media outlets, there is no real discussion of the issues. Some exceptions are Democracy Now and Radio Open Source.

Another issue that concerns me is all the talk about being “fair and balanced”. It seems no matter what the topic, you have to have a so called expert from each side. Now for some topics this may be appropriate but for other topics it gives a very misleading representation of where things stand. Take global climate change as an example. Almost every TV show wants to have someone from “each side” and they always seem to be able to dig up the one or two people who (for a variety of reasons I won’t go into) who disagree with the majority of scientists. This leads

All of this leads me to be less trusting of any source and to have to do research to find out where the “truth” lies. Fortunately, I am an information professional and so have experience in evaluating sources, but not every does that.

I am hopeful that things may change in the future but it will likely not be the near future. Maybe in the future there will be true debate on issues instead of the talking points and sound bites we currently get.

Technorati Tags: polarization