By Stuart Chaifetz

There’s been a lot in the news recently regarding Pharmaceutical companies and related issues, so, instead of focusing on one specific story, this time I am going to hit a few at a time.

I’ve written a lot about Big Pharma and their business practices. In this story from the NY Times, November 15, “Drug Makers Raise Prices in Face of Health Care Reform” we see how Big Pharma is preparing for health care reform by socking consumers with major hikes in prices.

“In the last year, the industry has raised the wholesale prices of brand-name prescription drugs by about 9 percent, according to industry analysts. That will add more than $10 billion to the nation’s drug bill, which is on track to exceed $300 billion this year. By at least one analysis, it is the highest annual rate of inflation for drug prices since 1992.”

By Stuart Chaifetz

If you like this blog, and the other work that we do with the ARISE campaign, then please consider joining or making a donation to our mother organization, the Animal Protection League of NJ. APLNJ (formerly NJ Animal Rights Alliance) is a grass-roots group that has been fighting for animals for more than 25 years. Any donation you can make will truly be appreciated! http://aplnj.org/donation.htm

Thank you!

Animal Protection League of NJ

www.AskUsWhy.com

And now back to our regularly scheduled blog.

By Stuart Chaifetz

Tales from the Dark Side of Big Pharma, Part 14,638

The Never Ending Story

When I started the “Dark Side of Big Pharma” series, I envisioned three or four blogs that dealt with fraud and corruption within the Pharmaceutical industry. I thought that under this banner I could take a little time and explore the human ramifications of drug testing, and then go back to more animal centric experimentation.

Once I began to research these issues, and saw how seemingly endless the controversies regarding Human Clinical Trials and fraud were, what started out as “Dark Side” I, II, III, expanded quickly to IV, V, and then threatened to escalate to blogs X, XX and that most interesting of all Roman numeral combinations, good ol’ XXX (perhaps then I would have found a ‘happy ending’ to this series).

By Stuart Chaifetz

The Dark Side of Big Pharma V

Over/sight

I’ve been spending a lot of time exploring Human Clinical Trials (HCT), because they are the bridge between animal experiments and wide spread use of pharmaceutical drugs. This pivot is where millions of dollars and years of research are put to the test - a test that they fail 90% of the time. The reason why HCT’s fail so dramatically is because animals are poor models for gauging human responses to drugs.

Even though the FDA has cited certain clinical trials for fraud and abuse, their oversight is merely the proverbial drop in the bucket. For this blog, I want to show you just how tiny that drop is - and why the FDA can’t even find the bucket.

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.