Saturday, September 12, 2009

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.

When the FDA discovers that there are problems with a clinical trial, they issue warning letters, such as this one that was sent just over a month ago to “Johnson & Johnson Pharmaceutical Research & Development, LLC” which is stationed right here in New Jersey. This letter goes into detail about the problems with the study, including “Failure to ensure proper monitoring,” “Failure to ensure that an investigation was conducted in accordance with the general investigational plan,” “Failure to secure investigator compliance,” and “Failure to ensure that only investigators who were qualified by training and experience were selected as appropriate experts to investigate a drug.”
Here are two more warning letters issues in 2009. This one to Psypharma Clinical Research, Inc. and this one to HealthwoRx. You’ll notice in these and other such letters there are deep concerns over “informed consent” and poor record keeping. Here’s a particularly disturbing letter sent to the Children's Hospital Boston where, according to the letter, there was no information that consent was given for one child from their parent.
By the way, the use of the word “child” is my own design; in the letter and study they are referred to as being a “subject,” the same terminology used for rats, mice or any of the other millions of animals that are experimented on. It seems we all lose our individuality when the experimenters come to town.
Bearing off from vivisection issues for a moment, check out some of the other warning letters the FDA has issued regarding animals that are slaughtered for food, such as this one sent on August 28 to a dairy farm in Minnesota, and which you might want to pass on to your friends who eat meat and drink milk:
“Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.”
The FDA also keeps a list of “Disqualified / Totally Restricted” Clinical Investigators, which can be found here. Here’s just one case, involving a William H. Ziering, M.D.
“The Center for Drug Evaluation and Research (the Center) of the United States Food-and Drug Administration (FDA) has information indicating that your client, William H. Ziering, M.D., repeatedly and/or deliberately violated federal regulations in his capacity as an investigator in clinical trials with investigational new drugs. Additionally, the Center has information indicating that Dr. Ziering submitted false information to the sponsors of the clinical trials.”
Falsified data in human clinical studies is a major issue, as are the problems with Institutional Review Boards, and human trials conducted in third world countries.
And that’s where we are headed to in the next blog.

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