“I know one day I will get out of this chair and pick up my son
and hold him right. I promised my family that I would walk again, and I will make that dream come true.”
Roman Reed, paralyzed from the waist down, speaking about the lifting of the stem cell research ban in 2009.
It is a dream held by virtually every victim of crippling spinal cord injuries and their care-givers, a treatment that could bring back feeling and restore the use of disabled limbs. Stem cells have offered hope that the dream will soon come true. They are wondrous cells, able to transform themselves into any type of cell in the body, muscle, cardiac, even the mysterious neurons that make up our nervous system. Specifically, embryonic stem cells, typically derived from embryos produced for fertility treatments, had shown the greatest promise in the treatment of both injuries and disease.
Geron, a Menlo Park biotechnology company, was the undisputed pioneer in the field. They were the ones who funded much of the research by the University of Wisconsin that led to the discovery of embryonic stem cells in 1998. Geron helped fund the 2005 research, that found when rats paralyzed by spinal cord damage were injected with stem cells, transformed in the laboratory into nerve cells, they could actually regain the use of their paralyzed limbs. It was also Geron which in 2009 gained government approval to begin the first clinical study on humans of this promising therapy. This initial study was only designed to test whether the injection of modified stem cells was safe, but two years into the study, researchers had not found any significant adverse effects. George Q. Daley, a leading stem cell researcher at Harvard Medical School was recently quoted as saying, “A safe first trial would have paved the way for many others to follow.”
Notice the use of the words “would have.” On November 14th of this year, Geron announced that it was halting its stem cell research. It wasn’t because the treatment was dangerous. All four of the patients tested so far were fine. It wasn’t because the stem cells had proved ineffective. Their initial study was only on safety not efficacy. It wasn’t that they were concerned by bad publicity or protests by anti-abortion activists who objected to the use of embryonic cells. The company had successfully weathered that uproar for years. No, the sole reason given for cancelling this miraculous treatment, which had given hope to thousands, paralyzed by spinal cord injuries that they would one day be able to walk again, was financial.
John A. Scarlett, Geron CEO
John A. Scarlett, Geron’s chief executive officer said in a company news release, “In the current environment of capital scarcity and uncertain economic conditions, we intend to focus our resources on advancing our…two novel and promising oncology drug candidates.” Stem cells did offer tremendous profit for the company, but not fast enough. Because of the nature of the treatments and the requirements of the FDA regulatory process, stem cell therapy was not expected to show a profit for five to ten years. By shifting resources to the two cancer drugs the company executives expected to show a significant profit within 20 months. Scarlett went on to explain, “By narrowing our focus to the oncology therapeutic area, we anticipate having sufficient financial resources to reach these important near-term value inflection points for shareholders without the necessity of raising additional capital.” In order to achieve these goals, they will phase out all stem cell research, not just for spinal cord injuries, but other promising treatments as well to help heart patients, diabetics, people with autoimmune disorders and those suffering from Alzheimer’s disease. The company will also lay off 66 people, 38% of their workforce.
Christopher Reeve
Forget the dreams. Forget the hope. Even if other companies take up stem cell mantle, and at least one is doing just that, the Geron funded research was the first and only one approved for human testing. Geron’s abdication of the field will set back stem cell therapy for years. Daniel Heumann is a board member of the Christopher and Dana Reeve Foundation. The foundation was named for the Superman actor, paralyzed from the neck down in an accident ,who died waiting for a treatment like this. In response to the Geron decision Heumann expressed the anger of many when he said, “I’m disgusted. It makes me sick, to get peoples hopes up and then do this for financial reasons is despicable. They’re treating us like lab rats.”
Geron, a Menlo Park biotechnology company, was the undisputed pioneer in the field. They were the ones who funded much of the research by the University of Wisconsin that led to the discovery of embryonic stem cells in 1998. Geron helped fund the 2005 research, that found when rats paralyzed by spinal cord damage were injected with stem cells, transformed in the laboratory into nerve cells, they could actually regain the use of their paralyzed limbs. It was also Geron which in 2009 gained government approval to begin the first clinical study on humans of this promising therapy. This initial study was only designed to test whether the injection of modified stem cells was safe, but two years into the study, researchers had not found any significant adverse effects. George Q. Daley, a leading stem cell researcher at Harvard Medical School was recently quoted as saying, “A safe first trial would have paved the way for many others to follow.”
Mad4science 