QDIS Blog

I came across this article and think there may be a point to it. The authors claim that outsourcing in the pharmaceutical industry is no longer an option but a necessity.

BMS claims outsourcing no longer an option

While there is some truth to this, it also ignores what would happen if there is a down-turn in the industry or if a major problem should happen at a contract manufacturer. Although I hope it doesn’t happen, if such an event would occur, it would definitely have a major impact on the industry. Also, I think if major pharma companies have an excess of capacity, they won’t outsource but keep it in-house.

I firmly believe that outsourcing is indeed important but I don’t share the opinion that it is no longer optional. The choice to outsource should be made carefully and with a eye on what is important. not all activities can or should be outsourced. Outsourcing of activities that bring an added value to the company are ones that are prime candidates for outsourcing.

Technorati Tags: Bristol-Myers Squibb, drug development, outsourcing

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I’ve posted several times that I think Roche is doing a great job getting the capacity to provide Tamiflu to the world. Roche today announced that they now have in place a supply chain for the US.

U.S.-BASED SUPPLY CHAIN FOR TAMIFLU FULLY OPERATIONAL

They don’t specify who is providing the bulk active, but I have my suspicions. It is again good to note that if something should occur and Tamiflu is needed on a vast scale, Roche already has a supply chain in place.

Technorati Tags: Roche, Tamiflu

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It seems everything these days is becoming more and more polarized and it has me concerned. There are a whole variety of issues where this has come to the fore.

• 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

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I read in a recent Chemical and Engineering news issue that Cambridge Major Labs will be launching a cut-rate research service. They are evidently trying to compete head-to-head with cheaper labor sources in China and India. To do this, they will hire industrial post-docs to do the work. The typical rate for an FTE in the US is $200,000 vs $60,000 annually in India or China. Cambridge Majors will be offering their industrial post-docs to their customers for a rate of $120-150,000.

Personally, I think this is a poor decision trying to compete on price. If price is truly the reason that process development and research is going to China or India, then offering only a 25% discount isn’t going to do it. They could go to India or China and save 50% over the low end of their offer.

I also firmly believe you get what you pay for. I’d much rather spend the extra $50,000 and get experienced people who have been in the industry for a while rather than a new industrial post-doc fresh out of graduate school.

I think this whole mentality in the US of focussing almost entirely on price is very detrimental. It serves to erode the expectations for price in the future. When you start offering low prices, this becomes the new norm and further price reductions are expected in the future. I’ll keep my eye on this to see what develops in the future.

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A recent article from Nature caught my eye concerning bird flu.

news @ nature.com - Controlling immune response may cut bird flu death rate - Study shows how H5N1 ravages the body.:

It seems the H5N1 replicates at a much greater rate than typical flu viruses and it basically causes the body to over-respond creating what is referred to as a cytokine storm. This eventually leads to organ failure particularly the lungs.

One of two things could be happening. First the body over reacts simply because the virus replicates so rapidly. The second could b that the virus produces a compound that over stimulates the immune response. This second explanation may be a reason as to why Tamiflu which inhibits viral replication, has not proven very useful. Another reason could be that the proper dose of Tamiflu for fighting avian flu has not yet been determined.

Technorati Tags: avian flu, bird flu, H5N1

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The FDA has given the okay to Iomai to test their flu vaccine in a patch based delivery system. They will compare it against the standard flu shot.

United Press International - Health Business - FDA OK’s trial of Iomai’s flu vaccine patch:

I find this an interesting delivery system for vaccines and this could be a major step forward. THeir are some people I know who don’t get the flu shot each year mainly because they have a fear of needles. I do know though that getting any sort of medicine across the skin barrier is difficult and one of the primary reason there aren’t more drugs delivered by patches.

Technorati Tags: flu, Iomai, vaccine

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A recent article from NY Times talks about how airlines are responsible for spreading SARS.

Speed of the Spread of Flu Is Linked to Airline Travel - New York Times

Most people I think came to this conclusions just based on what was reported in the main stream media.

Here’s the actual article:

PLoS Medicine: Empirical Evidence for the Effect of Airline Travel on Inter-Regional Influenza Spread in the United States

They also used the flight ban after Sept. 11, 2001 to see what affect that had on the spread of flu. Flu that winter was delayed and also prolonged and this is likely due to the changes in airline travel.

Here is the conclusion:

Although the mechanisms driving the seasonality of influenza epidemics are still not well understood, our findings do suggest that fluctuations in airline travel have an impact on large-scale spread of influenza. At the regional level, our results suggest an important influence of international air travel on influenza timing as well as an influence of domestic air travel on influenza spread in the US. However, for the global influenza pandemic widely believed to be inevitable, the efficacy of travel advisories, flight restrictions, or even complete flight bans as a control measure is still uncertain.

Other Resources

PLoS Medicine: SARS: Systematic Review of Treatment Effects:

Technorati Tags: air travel, flu, SARS

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The Journal of American Medical Assoc (JAMA) has released an article on renal and arrhythemia events related to Cox-2 inhibitors.

JAMA — Abstract: Adverse Effects of Cyclooxygenase 2 Inhibitors on Renal and Arrhythmia Events: Meta-analysis of Randomized Trials, September 12, 2006, Zhang et al. 0 (2006): 296.13.jrv60015:

The drugs studies were rofecoxib, celecoxib, valdecoxib + parecoxib, etoricoxib, and lumiracoxib.
It should be pointed out that this is a meta analysis.

Here’s there conclusion.

In this comprehensive analysis of 114 randomized trials with 116 094 participants, rofecoxib was associated with increased renal and arrhythmia risks. A COX-2 inhibitor class effect was not evident. Future safety monitoring is warranted and may benefit from an active and continuous cumulative surveillance system.

Here is a link to the pdf of the full article.

Adverse Effects of Cyclooxygenase 2 Inhibitors on Renal and Arrhythmia Events: Meta-analysis of Randomized Trials — Zhang et al., 10.1001/jama.296.13.jrv60015 — JAMA: The Journal of the American Medical Association

It seems the take home lesson is that Vioxx (rofecoxib) definitely has problems with both renal events and arrhythmia. Celebrex (celecoxib) did not show any increase in the risk of cardiovascular events. For the other drugs the results were unclear.

Other Resources

• Hotline: March, 2005 - The Safety of COX-2 Inhibitors
• Citebase - Practical approaches to minimizing gastrointestinal and cardiovascular safety concerns with COX-2 inhibitors and NSAIDs
• COX-2 Inhibitors – Cardiovascular and Gastrointestinal Safety (pdf)

Technorati Tags: Celebrex, COX-2 inhibitors, celecoxib, rofecoxib, Vioxx

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A recent press release from St. Jude Children’s hospital says they have found an early biochemical step that bacteria use to make their membranes.

St. Jude Children’s Research Hospital :: Solution to Bacterial Mystery Promises New Drugs:

This may lead to new drugs since this particular biochemical step does not occur in humans. They have discovered an enzyme that is vital to building the bacteria’s membranes and it is early in the biochemical sequence. This means it should be very effective and should not cause side effects in humans once drugs are identified to inhibit this enzyme.

Technorati Tags: antibiotics

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Tuberculosis (TB) has been making a come back for a long time. Although it has been practically wiped out in the Western world it is still fairly prevalent in other parts of the world. Now it seems there is a strain that can not be treated by the commonly used prescription drugs.

TB strain identified as ‘virtually untreatable’

There are over 425,000 cases of multi-drug resistant (MRT) TB each years world-wide mostly in India, China and the former Soviet Union. The resistance develops primarily because treatment isn’t followed through completely.

Also, TB isn’t the only bacteria developing resistance. many common bacteria are now occurring that are resistant to many common anti-biotics and the number of drugs to treat these is not increasing at a equivalent pace.

The main problem is these drugs don’t generate huge financial numbers for big pharma and something is going to have to change before advances are made. Maybe once it again becomes a common problem like it was back in the early 20th century will there again be a resurgence in discovery activities related to antibiotics.

Other Resources

• WHO | Tuberculosis
• Center for Disease Control | Tuberculosis
• MedlinePlus: Tuberculosis
• Tuberculosis - Wikipedia, the free encyclopedia

Technorati Tags: antibiotics, drug resistance, tuberculosis

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