FDA Claims Human Body Is a Drug and the Authority to Regulate It

According to the National Institutes of Health, Stem cells are cells with the potential to develop into many different types of cells in the body and serve as a repair system for the body. There are two main types of stem cells: embryonic stem cells and adult stem cells. Scientist believes they may be used to make cells and tissues for therapy of many diseases, including Parkinson's disease and Alzheimer's disease.

Now the Federal Drug Administration (FDA) and the government want to make a ridiculous claim suggesting they own your stem cells because they are drugs. This has come about as a consequence of the FDA’s latest claim in its dispute with a Colorado clinic over its Regenexx-SD™ procedure, a non-surgical treatment for people suffering from moderate to severe joint or bone pain using adult stem cells. The Food and Drug Administration has filed an injunction to stop the clinic from using a person's own stem cells to alleviate pain.
The FDA argues that the clinic is violating federal standards by injecting patients with their cultured stem cells. The clinic's doctors remove cells from the patient and grow them in an outside lab before injecting the cells into painful joints. The backwards logic proffered by the FDA in court documents suggesting it has the right to regulate the clinic is twofold. First they state that “Stem cells are drugs and therefore fall within their jurisdiction.” Last, that the Colorado clinic “is engaging in interstate commerce and is therefore subject to FDA regulation because any part of the machine or procedure that originates outside Colorado becomes interstate commerce once it enters the state.”

The FDA in its own legal briefs and documents state that the agency wants to protect the market for FDA-approved drugs more than all else. If upheld in the courts, the implication of the FDA’s interpretation of the law, is that al cells produced by the human body are the property of the FDA and any use of these cells, even by the person that produces them would be against the law, even if it is to treat their own body. Because according to the FDA, “Stem cells, like other medical products that are intended to treat, cure, or prevent disease, generally require FDA approval before they can be marketed. At this time, there are no licensed stem cell treatments.”

This is just another example of how the FDA is concerned more with serving the interest of large drug and pharmaceutical companies over the people they supposedly are in existence to protect. They are quick to approve questionable medications like the chemical aspartame when it has been shown to cause cancer in rats.

Similar outcomes have occurred with Yaz (birth control), which the FDA first approved in 2001, with Yasmin to follow in 2006, but since then he two studies by Boston University School of Medicine and published in the British Medical Journal had shown that the risk for blood clots, or venous thromboembolism (VTE), was 2-3 times higher for those women who were taking pills that had drospirenone.

Still the query remains, how far can the FDA go into our private lives and are they actually concerned with protecting the public or making drug companies wealthier?

swear to blog

Given that I am still suspended with pay, I have more time to read scientific journals. When I was on the job, outside of teaching Research Methods and a Theory class, lecturing around the country on prison health, writing grants and publishing scientific papers, I rarely had time to read scientific journals as I would have liked. Sure I did, but on my free time my preferences was to consume newspapers, books of history and fiction.

Recently I read an article that caught my attention in the Journal Cell. To summarize it, it revealed that skin cells could be used to make embryonic stem cells. This was without the use, need or requirement of an human embryo. This was amazing to me. I mean, just by adding 4 genes to a skin cell, they could be made in essence "Tab-la rasa" to develop any of the 220 known cell types of the human body (so much for the debate on stem cell research based on the creation and destruction of human embryos for the same purpose). These cells were named pluripotent stem cells.

Now this is why I love science and always wanted to be one, outside of Mr. Wizard and Mary Shelly. Namely because science forces one to make use of prior information and think outside the box - such to create just as writing does.

Dr. Shinya Yamanaka of Kyoto University of Japan and the Gladstone Institute of Cardiovascular Disease in San Fransisco (in picture), found out he could try and do this procedure in mice. Taking it a step further, showing he could make these cells into any type of mouse cell, he used the cells he made to create 20 new mice. Although about 20 percent of the mice developed some form of cancer - he showed and did it.

I know that the replication studies in humans is some ways off, not to mention such studies in the mind of this humble scientist would have to be preceded by studies that show the procedure can be employed to make the 220 know human cell types in vitro first. Even with all of this, i do not think the debate on stem cell research is over. There is always room for the "holier than thou" to ad their two cents in two forms I figure. First President Bush, whose megalomania will lead him to say that he is responsible for the discovery via his policies that cut funding for human embryonic stem cell research and second, those who were against such research for theological reasons, who now will move the debate to saying only God can make life and man should not, even in the name of disease prevention and treatment, even if it from skin cells. Swear to Blog, i mean God.