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Impatient Patients Drive Market for Hope from Stem Cells to Jail Cells

On August 22, 2011, in Attorney Cory Reiss, Consumer Safety, General, Government, by Attorney Cory Reiss

When you’re sick, ethical debates about developing a treatment for your ills can look a lot less attractive than someone selling hope, pure and simple.  But someone has to do the dirty work.

A 57-year-old woman pleaded guilty August 18 to federal charges of trafficking in illegal stem cells.  Yes, stem cells: those cells that scientists can manipulate to make different tissues, that have raised hopes high for curing dread diseases, that prompted partisan and theological warfare over their collection from human embryos during the Bush years and beyond.

The U.S. Attorney for the Southern District of Texas issued a press release reporting that Fredda Branyon teamed up with a medical school professor in Charleston, S.C., to create stem cells from umbilical cord tissue.  She bought the umbilical cords from a birthing facility in Del Rio Texas, manufactured the stem cells through her company, Global Laboratories, LLC, and sold them to a person in Brownsville, Texas, on 27 separate occasions from April 2009 through February 2010.  The purchaser used the 183 vials of stem cells, which all told netted about $300,000, on patients with autoimmune diseases.

None of this was done with FDA approval, so Branyon pleaded guilty to introducing an unapproved new drug into interstate commerce.  She faces some jail time and a fine.

The case shines a light on a global trend in the trafficking and use of illegal stem cells.  From Hungary to India to the Dominican Republic, and now to Brownsville, Texas, patients are either desperate enough to seek illicit stem cell treatments or are being duped into believing they are getting a the legitimate treatment they are paying for—but the former is more likely than the latter.

One thing is clear, stems cell researchers have promised a lot more than they have delivered and a black market is moving forward without them.  How much of that is a product of the political wrangling over stem cell production from human embryos I don’t know, but supply-and-demand is a powerful force that will be exploited where the law ends and the jungle begins.  Criminal aspects aside, this U.S. case raises some interesting legal questions and potential causes of action involving, for example, the birthing center that sold women’s umbilical cords for a side profit.

It’s also poignant that the case is in Texas, home of staunchly conservative Governor Rick Perry, whose presidential bid has scrambled the 2012 race.  The Associated Press reports that Perry underwent a stem cell procedure on July 1 on his back.  Doctors injected stem cells into his spine that were made from his own fat cells with the apparent intent of building bone.

The FDA hasn’t approved this treatment and some doctors blasted him for having it, not only because it could be dangerous for him but also because it could be dangerous generally.  Dr. George Q. Daley, a past president of the International Society for Stem Cell Research, put it this way: “As a highly influential person of power, Perry’s actions have the unfortunate potential to push desperate patients into the clinics of quacks,” who are selling unproven treatments “for everything from Alzheimer’s to autism.”

In other words, quackery is Perry tested, Perry approved.  At least he knows where his stem cells came from—and didn’t come from.  But don’t be surprised if Perry touts his own procedure at some point as proof that stem cell therapies need not involve human embryos.

For Perry, this isn’t much of a logical leap. When you’ve already dismissed the pretty broad consensus that climate change and the human role in it are real and dangerous; when you treat evolution and creationism as equivalent “theories” in public schools; and when you pretty much ignore the scientific method as an actual method, approval by the FDA and scientific community for a new medical procedure is pretty much optional.

So now I’m confused: why is Fredda Branyon going to jail?

 
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