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I came across this article recently and having worked for BMS years ago, I always find it interesting to see what the company is up to.

For Bristol, steady course may be best navigation

In the past I’ve not been very hot on some of the deal makings of BMS and I still have my doubts but converting into a biopharma is fraught with challenges.

In “The Development Factory: Unlocking the Potential of Process Innovation” (Gary P. Pisano) he talks about the pharmaceutical industry as one that” learns before doing”. By that he means that we can do some experiments in the lab and then somewhat reliably scale those up to large scale with some probability of success.

The biopharmaceutical industry on the other hands “learns by doing”. That is, the knowledge in how to scale these processes is not there and many things can go wrong when you change scale. Therefore you almost invariably have to run large scale experiments to figure out what parameters to control to give you the product you desire. This is one of the reasons that biopharmaceutical products are so much more expensive then your normal pill, tablet or capsule.

My point in bringing this up is it is hard to take a certain mindset and approach to development that has been instilled at BMS for a long time, and change that mentality i a short period of time and be successful at it. While they may have a chance, there still are no examples of big pharma becoming biopharma. There are examples of biopharma becoming big pharma or at least very big pharma-like (think Amgen and Genentech).

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While I wish BMS the best (I still own a few shares of their stock as well as Genentech mentioned in this article) I don’t look for them to pull it off anytime soon and definitely not soon enough to become attractive prey for another big pharma.

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After being away for sometime for a variety of reasons including a pinched nerve in my neck, I’m finally back and hoping to post to this blog several times a week, although I doubt I will be able to get back to posting daily due to work and other issues.

I did find the following article I found recently interesting as it talks about differences in Congress regarding biogenerics.

AMNews: Aug. 11, 2008. Disagreements slow progress on biogenerics legislation … American Medical News:

I think the point about the period of exclusivity is a valid point and where I think the the greatest debate will occur. While it may take a while to get compromise I think something will indeed happen on this front in the next year. It may not be a great bill but at least it will be something
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Wow! I read today that the EU performed raids on almost all the major drug companies on Wednesday. This includes Pfizer, Sanofi-Aventis, GlaxoSmithhKline, Astrazeneca, Merck, and Johnson & Johnson.

E.U. raids drug companies in broad inquiry

The authorities are looking for evidence of abuse of patents and illegal deals to keep cheaper generics off the market. Here is a quote form the article.

The raids will help establish if companies created barriers to competitors, whether they misused patent rights or engaged in “vexatious litigation” and if some firms abused their dominance of the market.

It will be interesting to see what comes of this if anything. I’ll but we don’t hear anything else about this for months but I’ll certainly be keeping my eyes open for further information.
Technorati Tags: GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Sanofi-Aventis
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As you may have noticed I’ve had some time to get caught up on programs I tivo’ed. Another program I really enjoyed was Nova’s “Absolute Zero: The Conquest of Cold” which you can watch online for free.

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.

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I Tivo’ed Frontline’s “The Medicated Child” recently and finally got around to watching it the other night. This is a follow up from an episode they did on this back in 2001. You can watch and read about it online. It was somewhat disturbing at parts especially when they mentioned a young child who was on several atypical anti-psychotics at the age of four! Here are some of the interesting points brought up:

1. There has been a 4,000% increase in diagnosis of psychiatric problems in young children over the last ten years

2. Although doctors do not agree about bipolar in young children many kids are being diagnosed as being bipolar at ages as young as four years old.

3. There is a growing number of strip mall places offering “brain scans” looking at blood flow to the brain to give a diagnosis. The company featured was co-founded by a social worker and she was the one featured giving the family the diagnosis of the problem. To me this edges on the verge of giving medical advice but not being a medical doctor.

4. In one case they highlighted it was teachers who told the parents their child had ADHD. I know teachers and I do not envy their job but I think suggesting an actual diagnosis is inappropriate.

5. Another big problem mentioned only in passing on the program was that many of these children are being treated by family pediatricians and not by child psychiatrists.

I’m not always a fan of highlighting individual cases which may or may not be typical. However, these do pull on our heart strings and it does highlight how desperate these families become when dealing with “the problem child”. I truly feel for these parents who are trying everything to help their child but nothing seems to work. Just take a look at the discussion page and read what some of these folks have gone through. This situation is what leads to some of these snake oil salesmen mentioned in point 3 above.

Part of the problem is the whole quick fix attitude especially in the US and the resulting expectation (re-inforced by the pharmaceutical industry) that a few pills can solve all your problems. I have always believed that in the case of mental issues that medication and therapy together are much more beneficial than drugs along.

I really liked the program and highly recommend it. You can watch it for free online and they also have lot of information and further interviews with experts here. There is also a Parents Guide.

I personally look forward to the day when we can run a blood test or do a brain scan and come up with a definitive diagnosis and be able to confidently prescribe medications that will solve the problem >90% of the time. Unfortunately, I don’t know if this will occur in my lifetime. This is one situation where I truly hope I am wrong.

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The subject of pharma spending on R&D versus Marketing is one that comes up frequently. Recently FierceBiotech has had an article on this.

Drug industry spends nearly twice as much on marketing than on research and development - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News:

Here is the link to the PLoS Medicine journal they refer to.

PLoS Medicine - The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States

It makes for some interesting reading. I personally think that there tends to be a discussion more on what should or should not be included as “marketing expenses” and the big picture tends to get overlooked. Maybe this is the tactic that is being used to avoid talking about the real issue.

The article does a good job I feel of at least explaining how they came up with their numbers. I’m sure there will be debate on what they decided to include and some of their assumptions but the very fact that it confirms the suspicions of the public will mean it will be readily accepted.

Their figure is $57.5 billion spent on promotion or 24.4% of every dollar versus $31.5 billion for R&D or 13.4%. THis means there is almost twice as much (1.8 actually) spent on promotion over R&D.

Here is the conclusion from that article.

From this new estimate, it appears that pharmaceutical companies spend almost twice as much on promotion as they do on R&D. These numbers clearly show how promotion predominates over R&D in the pharmaceutical industry, contrary to the industry’s claim. While the amount spent on promotion is not in itself a confirmation of Kefauver’s depiction of the pharmaceutical industry, it confirms the public image of a marketing-driven industry and provides an important argument to petition in favor of transforming the workings of the industry in the direction of more research and less promotion.

The article make the point that according to their figures the industry spends twice as much on promotion as it does on R&D. This will be controversial since it is counter to the common claim made by the pharmaceutical industry and confirms some of the perceptions of the man on the street.

I personally feel and have stated here several times that the industry as a whole does not seem to take seriously the perceptions on the street and the industry’s very actions taken to counter some of these perceptions only serves to reinforce some of those negative images out there. The industry seems to forget that perception matters and can be very damaging.

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This is the kind of stuff that gives the pharma industry a bad name. I’ve long had a problem with some of those on the marketing side who see

Congress questions Jarvik’s Lipitor lip service, credentials as part of celebrity-pitch probe - International
Herald Tribune:

I think the pharma industry needs to think about the “ethical” part of the name ethical pharmaceuticals, a term that isn’t used much anymore (maybe for good reason). I personally feel too many large pharma marketing departments are run by “soap and toothpaste” marketers who don’t understand (or don’t want to understand) the impact of what they are putting out there in terms of advertisements.

I feel there is too much emphasis on stretching the envelope of what is permissible and try to see what they can get away with and not enough focus on the perception of the drug industry in the eyes of the person on the street.

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Here are a couple of good blog postings about the low number of drug approvals in 2007.

The IN VIVO Blog: Another Dismal Year for New Drug Approvals:

Where have all the new drug’s gone: Industry’s medicine cabinet running empty on compounds- NJ.com

With only 18 approvals it is the lowest since 1983 when there were only 14. The FDA says final figures won’t come out until March but even then most of us think the total will likely not be any higher than 19. While there seem to be a lot of theories as to why this is the case, I don’t think there is any one singular explanation. I personally think it is a combination of the FDA being more cautious (although the FDA denies this and says there has been no policy change) and the fact that all the low lying fruit has been picked and it is indeed much harder now to find new and innovative therapies.

I do believe that some of the recent breakthroughs in basic research such as the human genome will eventually lead to new drug discoveries but that one of the primary issues is everyone under estimates how long it takes to go from basic research to commercial application, especially in the drug industry. This is one of the primary mind traps that everyone falls into in all industries but it seems to be exaggerated in the pharmaceutical industry.

I’m not sure what will help the situation and I’m not confident it will turn around soon. I am confident that in the long run, the issue will be resolved. I just hope it doesn’t take too long.

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Here is the first of what I am sure will be plenty of approvable letter from the FDA this year. Pfizer received an approvable letter for dalbavancin, a once weekly two dose antibiotic useful for methicillin resistant bacteria. Note that this drug came to Pfizer by way of their acquisition of Vicuron.

PharmaLive: Pfizer Receives Approvable Letter from FDA for Dalbavancin :

Basically the FDA wants more evidence regarding non-inferiority as the basis for approval.

I personally think that antibiotics is NOT an area where the FDA needs to be seen as holding things up. With the rising number of MRSA infections occurring even outside the hospital the need for new antibiotics is growing and will continue to grow. Having been affected by this personally and knowing that only vancamycin worked in that case the need for new antibiotics will continue to be of concern.

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It will be interesting to see how things develop with regards to new drug approvals and the FDA in 2008.
My guess is that for new drugs for which treatment already exists that the FDA will continue to demand evidence of not only of safety and effectiveness but also that is is an improvement over the currently available treatments. This seems to be shared by Fierce Biotech.

The FDA: Caught between a rock and a hard place - FierceBiotech

I can understand the FDA reacting to recent situations such as Vioxx but they do indeed seem to be sending a mixed message; emphasizing the need for speeding drugs to market but then seeming to have set a higher standard. THe FDA says therre jave been no policy changes but the fact that only 15 new drugs were approved in 2007 seems to indicate otherwise.

I just hope that we can have a open and honest discussion about risk management and acknowledge that all drugs have risk and many times that full impact of that will not be determined until after the drug has gone on the market.

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