Sunday, June 30, 2019

Bottle of Lies

Bottle of Lies: The Inside Story of the Generic Drug Boom is one of the most shocking books I have ever read. It is a rare book that manages to change how I shop, but how I buy pharma products has completely reversed: no longer will I buy any generics that are made in developing countries like India or China until they commit to fixing their issues.

I can't believe this book and its contents are not getting more press. It does a deep dive on the generic drug industry, illustrating how drugs are investigated/approved by the FDA and other agencies, even when they are highly unsafe. Despite a plethora of whistle-blowers who speak out because of their consciences, a huge number of unsafe drugs have come to market, and there are several reasons.

Firstly, international norms are not the same as they are in the US. Part of it is structural; employees in some jurisdictions have little training, are beholden to their employers (i.e. if they get fired, they may not eat), and live in societies where "greasing the wheels" and taking shortcuts are the way to get anything done. There is also a regulatory problem; while the FDA can make surprise visits to any plants in the US, the system is very lax with overseas facilities, with companies often receiving several weeks or months notice of an investigator's arrival. Furthermore, it's almost impossible to apply criminal charges to individuals who are caught cheating (with fake tests or weakened active ingredients etc.) when they're in foreign jurisdictions.

Second, the FDA's budget is based on the number of drugs it approves. So even when on-the-ground investigators want to shut a plant/company/drug down, they are overruled by higher-ups in the organization who may have different motives.

Third, there is political interference. Generic drugs are viewed as a cheap alternative in a country with soaring medical costs, and anything that slows down the process of bringing these to market is viewed as a problem.

Fourth, and this is a problem with all regulatory agencies, is that the FDA is subject to capture by the industry it seeks to regulate. People from private industry end up working with the FDA and vice versa, resulting in a cozy relationship that is not as strict and separate as it should be.

While many of these issues tend to apply mostly to the way generic drugs are regulated, they can even apply to branded drugs in some cases. The problems are so widespread that some hospitals have become their own little FDA's, identifying which sources of drugs they trust for their patients and which they don't, which makes you wonder just how asleep the regulators are. Some doctors even prescribe their patients ten times (!) the dose they're supposed to, knowing that the generics contains a watered-down active ingredient.

Read the book! It may change the way you think!

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