For the people of StemCells, Inc., one of the most respected stem-cell companies in America, the work they do is more than just a job. They are fighting to ease suffering and save lives. When they use stem cells to challenge spinal-cord injury, it is for people like my son, Roman Reed, paralyzed from the shoulders down. Every step of the way is hard as they struggle to do the impossible with the invisible, using microscopic cells to fight conditions that have never been defeated in the history of the world. And every detail of their work must comply with the rigorous standards of the Food and Drug Administration (FDA), which controls the approval process.
Now imagine trying to cure paralysis, blindness, children's brain disorders, and Alzheimer's disease while being sued in court! Unfortunately, that is the situation faced by StemCells, Inc. The company is being sued by a former employee, Rob Williams. In his complaint, Williams alleges that he "noted poor sterile technique, failure to adhere to current Good Manufacturing Practices in the company's manufacturing process, and substantial deficiencies in the company's Manual Aseptic Processing of HuCNS-SC (Human Central Nervous System Stem Cells) cell lines...."
And the company's response?
The Company has reviewed the complaint filed by Mr. Williams, a former employee whose employment was terminated for performance deficiencies, and finds no merit to the allegations. ...
[T]he elements of manufacturing practices that concerned Mr. Williams were immediately and carefully reviewed by the Company. ... Over the years, we have consulted with multiple experts in the field and we believe our processes, procedures and controls, as fully described in our regulatory filings, are appropriate for a company at our early stage of clinical development and comport with applicable guidelines and regulations. To date, no patients participating in the Company's clinical studies have experienced any product related safety concerns.
My non-lawyer interpretation of all this? A former employee, fired for "performance deficiencies," is suing the company, accusing it of dangerous sloppiness.
If you have ever visited a modern and reputable research lab, I am sure you remember the "clean room" sterility that is standard operating procedure for today's science. I find it hard to believe that one of the nation's most preeminent stem-cell companies would not abide by normal safety regulations.
Nor can we forget the FDA, which will ultimately decide which stem-cell products are allowed to reach the patients of America. Do you remember the years of tests, pre-tests, and re-tests that the FDA put Geron through as they struggled to get their stem-cell product to market? Every procedure was examined with a near-brutal thoroughness, literally studied under a microscope, to make certain that whatever was put in a patient was safe. A frequent complaint against the FDA is that they are too careful, too cautious, too conscientious. I cannot imagine that they have suddenly changed their ways. If, God forbid, there are procedural shortcomings or errors, that is what the FDA is for. They are quite capable of saying no, in which case the project stops -- until and unless the deficiencies are remedied.
May I suggest two points of principle as the long court process begins? First, American law stands on four words: "innocent until proven guilty." Anyone can make accusations of wrongdoing, but those charges must be also proven, and these charges have absolutely not been proven yet. And second, let's remember the importance of sheer common sense. Is it likely that a company on the verge of colossal success would jeopardize everything they have worked toward for so long with sloppy housekeeping?
Follow Don C. Reed on Twitter: www.twitter.com/diverdonreed