By Stuart Chaifetz

The Dark Side of Big Pharma IV

Fraudorama

Fraud is a pretty powerful word. When something is painted as being a fraud, we immediately begin to dismiss it as being illegitimate, corrupt and deceitful.

It’s also a dangerous word to use, because the person wielding it can be dismissed if there is no evidence to back up their claim. It’s not something that I throw out casually and I am not at all comfortable simply accusing someone, or in this case members of the Pharmaceutical industry, of fraud.

By Stuart Chaifetz

The Dark Side of Big Pharma III:

Institutional Review Boards

The first line of defense against dangerous practices occurring in Human Clinical Trials are Institutional Review Boards (IRB). These boards are meant to monitor and approve research that has been taken to the human level, and, specifically, to protect the rights of people who are being tested.

Thankfully, with these IRB’s Elliot Ness style of Untouchability, there are never any problems and corruption doesn’t exist at all within the biomedical/human research community.

Right.

By Stuart Chaifetz

The Dark Side of Big Pharma, Part II

Because animal biology is so different than ours, and drugs react differently on different species, nine out of ten animal tested drugs fail when taken to the human level. This 90% failure rate means that when drugs are sent for human clinical trials, researchers are literally experimenting on human beings.

While we know of the poor translation of animal data to human use, there is a lot about human clinical trials that is not well known, such as what happens when experimental drugs are given to human test subjects, who watches out for these people, is it an honest process, and how do business concerns factor in?

I’ll be exploring all of these questions and their ramifications in the coming weeks. First though, let’s take a look at the US Food and Drug Administration (FDA), the government agency that investigates human clinical trials, and what information they have that sheds some light on these studies.