ppp 03-28-08

Quote of the day: Remember that there is nothing stable in human affairs;

therefore avoid undue elation in prosperity,

or undue depression in adversity.

Socrates (469 BC - 399 BC)

I continue to furiously help my son with his house, my "grand house", as we have but 6 weeks until the birth of his child. Last weekend we worked on the basement bathroom. We enlisted the aid of my brother who is a wizard with a propane torch. Plumbing is a lesson in management. The supply of ram material (hot and cold water) must be managed through a distribution system (pipes) so that each appliance (producer) can perform its proper function. Similarly, the waste water must be managed as well as the venting to assure that the traps are not siphoned dry. Grabbing pipe, wrenches, solder and cutting tools and beginning without a plan would be a formula for disaster. There are strict rules to follow to assure safe distribution of the water and to avoid contamination. Plans must be approved and building inspectors assure that all is done well.

We hear a lot about the "pharmaceutical pipeline". The pharmaceutical pipeline has similar challenges; a safe and reliable source of the raw materials as well efficient distribution systems for the finished products. The FDA approves the plans and certifies the processes. The recent globalization of pharmaceutical supplies could be considered as the addition of another bathroom. The lack of the FDA as "building inspector" lead to recent problems with Chinese heparin. It is fortunate that the monitoring system in the USA worked well to limit the damages to the population.

What good is a good set of pipes if they remain empty? What is of most concern to the pharmaceutical companies and one that should be shared by the general population is the dearth of new chemical compounds to fill the pipeline. The disposition of the patents is similar to water flowing through supply pipes to a shower and the return out of the house. I offer no lament for lost patents. The path is defined and its life of potability limited. Reimportation and litigation (from which the FDA should provide some shield) are taking their toll on pharmaceutical company resources... the same resources which should be used for additional research into new chemical entities. May the pipes remain clear and the supply meet demand.

ps. Best answer this week to the question "How are you?" was "Swell... just swell"

pps. Occasionally, some of the links require FREE registration.... I'm sure you can handle THAT slight inconvenience.

In response to the Chinese heparin debacle the FDA will now open eight offices across China. Hiring will occur over the next 18 months. 好運氣 (good luck).

This week there should be some news about a generic version of the antipsychotic quetiapine, Seroquel. As a $4 billion a year drug, there is a lot riding on this one.

One way that cancers spread and invade other organs is by proliferation of blood vessels, called angiogenesis. Instead of large sporadic doses, a small group of children were given small daily doses of anti-angiogenesis drugs to see if the spread of their cancers could be controlled. Read about the good results and the start of a larger study.

Presidential hopeful, John McCaine, is pushing for “reimportation” of pharmaceuticals from Canada just as the practice is in decline due to Medicare Part D effects. Looks like we will all end up in the short end of the pharmaceutical stick whether a Democrat or Republican wins in the fall. Each side panders to the people who do not understand the macroeconomic scope of this practice and that it amounts to price controls on pharmaceutical. (Not to mention the dangers inherent the practice… counterfeit, adulterated, subpotent, placebo or poisonous.)

Treanda, bendamustine HCl, was just FDA approved for use against Chronic Lyphocytic Leukemia (CLL). Another weapon against cancer forged and approved.

With a potential drug bill of $300,000 per year some are calling for a reduction in the dosage of Cerezyme for Gaucher’s disease. Two sides argue; one that drug companies have inflated the dosage needed to pad profits and the other that patients are being under dosed for financial reasons. The voice of reason (me) would argue that individualization of dosing based upon objective evidence makes the most sense. While giving too much respresents a very expensive calorie source, too little can result in advancing anemias, pain, and organ failure. A very good friend of mine died of the disease last year so dollars and cents have to weighed by the real pain and suffering. Rationing will not be pretty but rational drug dosing is the only acceptable alternative. (ps there is an oral form under development that is expected to be eventually sold at the bargain price of $50,000 per year)

The adulterant in the Chinese heparin has been found, oversulfated Chondroitin sulfate. While this is the adulterant the FDA has yet to prove the link to the allergic reactions produced by the bad products. Will continue to follow this and provide updates.

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