The legal mess around embryonic stem cell research just got messier. Yesterday a U.S. district judge ruled that President Obama’s expansion of federal financing for the research, enacted last year when he lifted the Bush-era restrictions on creating new stem cell lines, was a violation of federal law.
Judge Lamberth ruled that the administration’s policy violated the clear language of the Dickey-Wicker Amendment, a law passed annually by Congress that bans federal financing for any “research in which a human embryo or embryos are destroyed, discarded or knowingly subjected to risk of injury or death” [The New York Times].
Here’s the gist of what happened: The Obama Administration said that its policy fit with Dickey-Wicker because no federal dollars financed the destruction of embryos. Under the new rules the few stem cell lines approved by the Bush administration were OK, and so were new ones from embryos that had already been discarded because they weren’t needed for fertility treatments anymore—if the donors had given their consent to the embryos being used for research purposes. In this compromise position, taxpayer money wouldn’t be used to create new stem cell lines from embryos, but federally funded researchers could work with new stem cell lines created by privately financed scientists.
Yes, you saw a similar headline in 80beats in January of 2009, but this time we mean it. We think.
Back in 2009 the FDA approved an application from Geron Corporation to begin the first human safety trials of a therapy derived from embryonic stem cells, a move that was heralded as a strong vote of confidence in this controversial but exciting area of medicine. But before the treatment of patients with spinal cord injuries could begin, the FDA reversed course and put a hold on the trial, noting that Geron had discovered cysts in some rats injected with the cells.
Since then, Geron has been scrambling to prove that its treatment is safe via new animal studies, and has agreed to change some procedures to minimize the likelihood of cyst formation. Now that the FDA has signed off, Geron expects to begin the small safety trial (involving only 7 to 10 patients) before the year’s end.
When scientists first created induced pluripotent stem cells (iPS cells) three years ago, they were hailed as a game-changing advance for medicine: Scientists hoped the engineered cells could duplicate the talents of embryonic stem cells, which can develop into any kind of cell in the body, while avoiding the destruction of embryos. However, a new study by one of the leading U.S. cell labs suggests that iPS cells, at least right now, have serious problems keeping them from reaching their potential.
Advanced Cell Technologies, the Massachusetts lab led by stem cell guru Robert Lanza, released a study of 25 embryonic lines and eight iPS lines in the journal Stem Cells last week. At first they found that human iPS cells could indeed generate blood vessel, blood precursor and retinal cells with characteristics similar to ones derived from embryonic stem cells, albeit with significantly reduced efficiency [Scientific American]. But the blood and retinal cells showed much higher rates of cell death and premature aging. According to Lanza, “there was a 1,000- to 5,000-fold difference” between the iPS cells’ ability to keep growing and dividing and the true embryonic cells’ ability, he says. “In terms of whether you can use the cells therapeutically or to study disease, that’s the difference between getting the study to work and being dead in the water” [Newsweek].
President Obama followed through yesterday on his plan to ease restrictions on stem cell use in research funded by taxpayer money. National Institutes of Health leader Francis Collins announced that the organization has approved 13 new lines of embryonic stem cells for research, and will consider 96 more lines for approval.
In March, Obama lifted President Bush’s restrictions on federally-funded research on embryonic stem cells, which limited research to a handful of lines created before August 2001. Obama could not on his own reverse the Congressional ruling that forbids scientists from using taxpayer money to create new stem cell lines from embryos, but the ruling allows researchers to use cell lines created by others in an ethical fashion. The NIH set up a panel to decide which stem cell lines met strict ethical restrictions. The cells, for instance, have to have been made using an embryo donated from leftovers at fertility clinics, and parents must have signed detailed consent forms [Reuters].
The South Korean stem cell scientist who falsified cloning data was convicted today of embezzlement and illegally buying human eggs. The Seoul Central District Court sentenced Hwang Woo-suk to two years in prison for embezzling research funds and illegally buying human eggs. However, it suspended the penalty, allowing him to stay free if he breaks no laws for three years [Washington Post]. The judge stated Hwang has shown remorse and said that despite his fraudulent research the scientist has made other genuine advancements in cloning.
In May 2005, Hwang published a paper in the journal Science, saying his team had extracted material from cloned human embryos that identically matched the DNA of 11 patients. It was claimed such a technique could be the key to providing personalized cures for diseases such as cancer, Alzheimer’s and Parkinson’s [BBC News]. The paper garnered worldwide attention, along with heightened suspicion, because cloning embryonic stem cells was thought to be impossible due to the complexities of human cells. Proving the critics right, an investigation later concluded that the data were intentionally fabricated. Hwang later confessed to obtaining eggs for the research from his female colleagues, a clear violation of research ethics guidelines. However, he maintained that he did not fake his research, and is still working on animal cloning at a local institute.
80beats: Obama’s Guidelines for Stem Cell Research Dodge Controversial Bullets
80beats: Is It Ethical to Pay Women to Donate Eggs for Medical Research?
80beats: Disgraced South Korean Cloning Scientist May Face Jail Time
The disgraced South Korean researcher whose breakthrough cloning research was exposed as a fraud in 2005 now faces up to four years in prison. Prosecutors asked for the four-year sentence in court today, where the researcher, Hwang Woo-suk, is standing trial for fraud, misusing $2.25 million in state funds, and violating bioethics laws by illegally buying human eggs for his research. “The people’s disappointment was very serious because their expectation for his stem cell research had been high,” an unidentified prosecutor told the courtroom. He said Hwang tarnished South Korea’s image abroad…. Hwang pleaded for leniency, saying if the court forgives him he is ready to “pour the last of my passion” into research [AP].
Hwang became a national hero to South Korea in 2004, when he claimed to have cloned human embryonic stem cells, a feat that was thought to be impossible because of the complexities of human cells. Embryonic stem cells are of great interest to medical researchers because they can develop into any kind of adult cell, and could theoretically be used to replace malfunctioning cells that cause disease. A year later, Hwang said the team created human embryonic stem cells genetically matched to specific patients — a purported breakthrough that promised a way to withstand rejection by a patient’s immune system [AP].
From reprogrammed skin cells, scientists have made live mice.
The accomplishment is the latest step forward in the exciting new field of reprogrammed cells, which may offer an alternative to embryonic stem cells…. [It's] the most definitive evidence yet that the technique could help sidestep many of the explosive ethical issues engulfing the controversial field [Washington Post]. Two new studies describe the process, and one team of researchers reports producing 27 live mice. While there were abnormalities and unusual deaths with some of the first generation of mice, [the] team produced enough normal mice this way to create hundreds of second and third generation mice [AP].
It was only three years ago that Japanese stem cell researchers found a way to reprogram ordinary skin cells to behave like embryonic stem cells, which are thought to hold vast potential for medical research because they can develop into any kind of body tissue–from heart cells to toenail cells. But researchers didn’t know if the reprogrammed adult cells, known as induced pluripotent stem cells or iPS cells, were capable of differentiating into every type of tissue, the way embryonic stem cells do.
To obtain a steady supply of unfertilized human eggs for medical research, New York’s Empire State Stem Cell Board recently authorized paying women to donate their eggs. The decision has set off a new round of discussion about whether paying for eggs is ethical. The board agreed that women can receive up to $10,000 for donating eggs, a painful and sometimes risky process…. Proponents say compensating women for their eggs is necessary for research, and point out that women who give their eggs for fertility purposes are already paid. Others worry that the practice will commodify the human body and lead to the exploitation of women in financial need [The New York Times].
At the annual meeting of the International Society for Stem Cell Research this week, British researcher Alison Murdoch described a less controversial “egg sharing” program that has met with success. Women struggling to conceive can obtain IVF at a discounted rate, in exchange for donating some of their eggs for research…. In 2008, Murdoch’s team had 191 enquiries from interested women and ended up obtaining 199 eggs from 32 couples. “We are getting donors and we are getting eggs,” says Murdoch. The team is using the eggs in experiments into “therapeutic cloning”, which could ultimately produce stem cells matched to individual patients [New Scientist].
British researcher Karim Nayernia says he has produced human sperm from embryonic stem cells for the first time, but his claims have been met with some skepticism. Embryonic stem cells can develop into any kind of cell in the body, but researchers have struggled for years to produce reproductive cells from stem cells. The task is particularly difficult because it requires a complex form of cell division called meiosis, which reduces the number of chromosomes per cell by half [Nature News]. In the new study, published in the journal Stem Cells and Development, Nayernia says his team used a special cocktail of growth factors to transform stem cells into sperm.
But male fertility expert Allan Pacey says the lab’s creations are too abnormal to be called sperm. “I am unconvinced from the data presented in this paper that the cells produced by Professor Nayernia’s group from embryonic stem cells can be accurately called ‘spermatazoa.” … Pacey said in a statement that the sperm created by Nayernia did not have the specific shape, movement and function of real sperm [AP].
Although ethical debates about the use of embryonic stem cells continue to rage, stem cell technology is beginning to make its way into the medical marketplace. Yesterday, General Electric division GE Healthcare announced that it’s teaming up with the biotechnology company Geron in a venture that will use embryonic stem cells to develop products that could give drug developers an early warning of whether new medicines are toxic [Reuters].
The agreement marks the first time that a company of GE’s stature and size has announced a business venture involving the controversial field of embryonic stem cells. That could reflect a more tolerant climate for the technology in the wake of the Obama administration’s recent relaxation of restrictions on embryonic stem-cell research [The Wall Street Journal]. Supporters of embryonic stem cell research say the work will lead to a host of treatments for cancer and other diseases, while opponents believe that the destruction of any human embryo is unacceptable.