Pharma Regulations

Ever since the new millenia of the 20th century, many people feared doctors.  Their treatments often worked, often didn't, and when the happenstance was of the latter, people were not the happiest of people.

Ben Goldacre outlines the process of how bad pharmaceuticals come to market in his book, "How Drug Companies Mislead Doctors and Harm Patients."  The process goes something like this:

A drug is manufactured for the market.  The drug is then tested thoroughly by the Federal Drug Association and associated corporations; however, the only regulation is that the drug must be better than a placebo.  It's an extremely lax regulation.

However, often the drug is tested by the manufacturer themselves.  This means that they can simply throw away all of their negative trial data and put forth only the positive in order to set their product to market.

Side effects are only tested by a few thousand people.  Therefore, niche communities and sub-populations are not tested.  Meanwhile, when follow-up studies are conducted, many negative results are still not published (nearly five times as many positive results are, however).  Therefore, a grossly incompetent or outright unhealthy drug can stay on the market for years before it is finally removed from pharma shelves.

Often, screening is lackluster in the first place, with drugs only being tested for a short period of time.  It is difficult to test drugs for the entire lifespan of their trials due to the length of modern lifetimes and therefore many settle for indicators of health, such as blood pressure, that indicate whether the drug is helping or hurting a patient.  However, failure to investigate long-term effects can lead to drastic mis-prescriptions.

Public health is a federal concern.  It is the government's responsibility to tighten these regulations in order to minimize the number of deaths caused by medical complications of lackluster-screened drugs.  However, it isn't quite so simple, as often the government must put a drug on the market immediately during a crisis (such as Tamiflu during the bird flu scare a few years ago).  Life-long screening and follow-up studies are impractical to do in such scenarios, and often times there is no true way to solve the pharma crisis aside from a wait-and-see approach.

OH NO SCALE: Very bad

[1] http://arstechnica.com/science/2013/01/profits-over-your-dead-body/