Tuesday, May 17, 2011

Drug Shortages

"The global market is starting to show cracks; the world is definitely not a flat billiard table. It's looking more and more like an out-of-balance roulette wheel."
-Edward Tenner, The Atlantic.com
I've seen a lot of buzz lately regarding a Washington Post story about a Shortage of Key Drugs.
A record 211 medications became scarce in 2010 — triple the number in 2006 — and at least 89 new shortages have been recorded through the end of March, putting the nation on track for far more scarcities. The paucities are forcing some medical centers to ration drugs — including one urgently needed by leukemia patients — postpone surgeries and other care, and scramble for substitutes, often resorting to alternatives that may be less effective, have more side effects and boost the risk for overdoses and other sometimes-fatal errors.
The article identifies three factors for the increasing scarcity:

1. Major pharmaceutical companies purchased smaller companies with patents on life-saving drugs. But when the patents expired, the big company abandons production because it will now be less profitable.

2. The pharmaceuticals claim there is tougher regulation of production by the FDA (which the agency denies).
"Shortages of pre-loaded epinephrine syringes and propofol, for example, occurred when suppliers dropped out just as the FDA was demanding additional documentation."
3. Globalization of manufacturing means a storm or natural disaster anywhere in the world can stop production of an item with many components. Globalization also raises concerns about the quality of the ingredients used.
The drug cytarabine has caused the most concern and gotten the most attention because it is highly effective for treating several forms of leukemia and lymphoma. [...] Many hospitals are running low, and some have run out completely. [...] Cytarabine’s scarcity was caused by hitches that two out of the three manufacturers hit in obtaining raw materials, as well as the discovery of crystals in some shipments.
At least 19 patients were sickened and nine died in Alabama this year after being infused with a solution through their feeding tubes that was apparently contaminated with bacteria by a pharmacy using an unfamiliar ingredient because of a shortage
Bottom Line

A common knee-jerk reaction is, "See this is what happens when companies control the heath industry. Government needs to be in control."  But look at Russia, Cuba, England for counter examples of lack of care and resources for the common man when the government runs the show.

The solution is greater competition (not patents). But reform is also needed at the FDA level. When regulation is too strict it becomes a barrier to entry and small companies can not compete. Regulation can also ban foreign companies. But too little regulation is also a problem as we know companies will cheat and defraud the consumer with fake or even dangerous drugs.

So how about this. Every day(?) take one random sample from production. Have a competitor test it for quality control. Perhaps monthly have FDA also test a sample to ensure that competitors are not in collusion and hiding bad test results.

When contamination is found, don't fine the company - that is not really a deterrent; that just pushes the fine to the consumer with higher prices. Instead prosecute the CEO for endangering the health of the public. Having a CEO (and other company officers) go to jail seems more effective than paying a fee from company profits. Prosecute for allowing a dangerous drug to be released. Not for intent or ill will. But negligence for failing to adequately test the quality of inputs and outputs. A company must be responsible for the drug it creates - no excuses.

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