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Thursday, December 6, 2007

Outsourcing Drug Fabrication to China posing a threat?

Until now 70% of readers of Pharmalot think that outsourcing to China poses a security risk.

China’s booming pharmaceutical industry has doubled exports to the US in the past five years, undercutting competitors and making American consumers reliant on the safety of Chinese factories and captive to any disruptions in trade relations.

I had never thought of this. In a previous post with reasons for Drug Companies to move to China I hadn't thought of this scenario:
Consider this scenario: If a major anthrax attack were to occur in the US — larger than the one in 2001, when five people died — the pharma companies that make the two antibiotics most suitable for treatment, Cipro and doxycycline, would have no choice but to rely on China or India for key ingredients once US stockpiles were exhausted, the Star writes. Those ingredients no longer are made in the West.

My main concerns were:
# Protection of patients in trials is probably not as solid as in Europe and the US.

# Data obtained from this research might not be applicable to patients in Europe and the US, two other important markets for these companies.

# This could be due to differences in pharmacokinetics as well as diagnostic differences between very different cultures. Is depression in China tolerated and is it the same as in the US and Europe?

# Do they adhere in the same manner to for instance the DSM IV criteria?

# Is money not a strong motivator for participation in trials?

Pharmalot has a lot more disadvantages of this development, please read on and don't forget to vote.

On Chine Hearsay, China law, business and economics commentary, there is also an interesting discussion on this subject, please read the comments

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