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Health Policy, Research, Stem Cells

Stanford legal expert discusses future of stem cell research on ScienceLive

Stanford legal expert discusses future of stem cell research on ScienceLive

UPDATE: A transcript of the talk is now available. (Scroll down to “The Future of Stem Cell Research” box.)

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Ever since U.S. district court judge Royce Lamberth dismissed a case that threatened to ban federal funding for all human embryonic stem cell research, scientists and others in the biomedical community have wondered what’s next for the field. Today, Stanford law professor Hank Greely, JD, joins a live online chat hosted by Science to discuss the ups and downs of stem cell policy over the past decade and the latest legal ruling.

For a quick primer on the issue, read Greely’s informative blog post on Lamberth’s decision and then tune into the ScienceLive chat at 12 p.m. Pacific Time.

Previously: Stem cell funding injunction overturned by federal court , Judge Lamberth’s stem cell opinion is disappointingly bad, More concern over US judge’s stem cell ruling and Stanford stem cell expert weighs in on district court ruling
Photo by California Institute for Regenerative Medicine

In the News, Research, Science Policy, Stem Cells

After the lawsuit, what’s next for stem cell research?

After the lawsuit, what's next for stem cell research?

One week ago, a federal judge threw out a lawsuit against government funding for human embryonic stem cell research. But, as Nature’s Meredith Wadman is reporting, the field remains vulnerable:

…[R. Alta Charo, JD] who studies law and bio­ethics at the University of Wisconsin–Madison] notes that the current US Congress is so politically divided it is unlikely to enact a law either explicitly permitting or explicitly prohibiting government funding for the research. But, she says, “nothing in this decision and nothing in the Dickey–Wicker amendment” stops a new president from quashing research simply by refusing to fund it. [Stanford's Hank Greely, JD] says that the best way to protect the research “is to get some real medical progress with stem cells” to prove the worth of the field.

This may prove difficult in the short-term though, as the field took a hit from the funding threat:

Although NIH approval of new stem-cell lines has resumed, and even accelerated (see ‘Bouncing back’), some say that it will take years to recover from the impact of the shutdown. Scientists who left the field in the interim might never return.

“Things have changed permanently. It’s not just going to go back to the way it was — not immediately,” says Meri Firpo, who researches stem-cell therapies at the University of Minnesota Stem Cell Institute in Minneapolis.

Previously: Stanford law professor on embryonic stem cell ruling, Judge Lamberth dismisses stem cell lawsuit, Stem cell funding injunction overturned by federal court and NIH intramural human embryonic stem cell research halted

In the News, Science Policy, Stanford News, Stem Cells

Stanford law professor on embryonic stem cell ruling

Stanford law professor on embryonic stem cell ruling

I wrote yesterday about the dismissal of the lawsuit against federal funding for human embryonic stem cell research. Now Stanford law professor and bioethicist Hank Greely, JD, has an in-depth look at the case and what could come next:

I thought this was a graceful, gracious, and fully professional opinion by Judge Lamberth.  The poor man had been been reserved twice by the DC Circuit, in different directions.  He did not attempt to play games with the latest Circuit decision and follow its letter while avoiding its intent.  While making it clear that he thought he had been right, he did what a judge is a supposed to do in applying the law in light of his position in the judiciary hierarchy.

As a former scientist and science writer, it’s really fascinating to view the legal side of how court cases like these work. I’m learning a lot about the judicial process. And it appears my education isn’t over yet, according to Greely, who asks:

So now what?

The plaintiffs could do four things:

1.   Ask Judge Lamberth to reconsider his decision:   Good luck with that.

2.  Appeal to the DC Circuit:  I think this is likely.

3.  Ask the US Supreme Court to take the case directly:  Good luck with that, too – the Court does that very rarely and only in real emergencies.

4  Quit:  I doubt it.

It looks like an appeal could drag out this process even longer–as detailed in Greely’s post. But I can’t leave you this time without also calling attention to a related post today on Science Progress by Jonathan Moreno:

Stepping back from this legal meandering, the larger importance of this incident lies in the fact that only research on biology has been subject to such a challenge. Even at the fever pitch of our culture wars, no advocates have thought to bring suit against the federal government for funding, say, geological studies that confirmed that the earth is more than 6,000 years old. Indeed, from the infamous Scopes “monkey” trial to present-day creationism lawsuits, biology (in particular, the teaching of evolution) has been the wedge into literal readings of the Biblical period of creation. The fact is that modern biology is threatening in ways that the physical sciences are not, a challenge for a country that is both founded on the promise of science and needs science to sustain its leadership role in the 21st century.

As a church-going, science-loving believer of evolution and biology (hey, we do exist!), I say Amen to that. But it’s a challenge that can be overcome. Right?

Previously: Judge Lamberth dismisses stem cell lawsuit, Stem cell funding injunction overturned by federal court and NIH intramural human embryonic stem cell research halted

In the News, Science Policy, Stem Cells

Judge Lamberth dismisses stem cell lawsuit

This morning, U.S. district court judge Royce Lamberth dismissed a case that threatened to ban federal funding for all human embryonic stem cell research. At issue was the Dickey-Wicker amendment, which prohibits federal money from being used to destroy or harm a human embryo. Stem cell scientists have successfully argued in the past that using the money to support research on stem cell lines that had been derived with other sources of funding sidestepped that requirement; the two plaintiffs who brought the suit disagreed. They also argued that embryonic stem cell research unfairly diverted federal money from the study of adult human stem cells, which are not derived from embryos. From this morning’s Washington Post:

“This Court, following the D.C. Circuit’s reasoning and conclusions, must find that defendants reasonably interpreted the Dickey-Wicker Amendment to permit funding for human embryonic stem cell research because such research is not ‘research in which a human embryo or embryos are destroyed,’” Lamberth wrote.

We’ve written about this issue numerous times before (see below). But to quickly get up to speed, you may want to read an April blog entry from Amy Adams at the California Institute for Regenerative Medicine, which nicely summarizes the background of the case.

Previously: Stem cell funding injunction overturned by federal court, More on ongoing stem cell court case, Judge Lamberth’s stem cell opinion is disappointingly bad, Stanford stem cell expert weighs in on district court ruling

 

Cancer, Stanford News, Stem Cells

Stanford study shows stem cell treatment improves survival of patients with metastatic breast cancer

Stanford study shows stem cell treatment improves survival of patients with metastatic breast cancer

Treating Stage IV breast cancer patients with high-dose chemotherapy followed by a rescue with their own, specially purified blood stem cells that had been purged of cancer, could significantly increase their chances of survival, according to new research from Stanford.

The long-term study (subscription required) was published online last week in Biology of Blood and Marrow Transplantation and is the first to analyze the long-term outcomes of women who received their own (autologous) stem cells that had undergone this purification process. According to a release:

High-dose chemotherapy is considered to be an aggressive treatment because, in addition to killing cancer cells, it also destroys a patient’s blood forming system. Therefore, such patients need to be rescued with stem cells that can restore blood production, which includes red blood cells, platelets and infection-fighting white blood cells. To increase the proportion of blood-forming stem cells in the bloodstream patients routinely receive drugs that “mobilize” the stem cells out of the bone marrow into the blood. Unfortunately, studies by many groups have shown that cancer cells often stowaway in the blood as well and may cause an eventual relapse.

As a result, in the mid-1990s Stanford researchers headed by professors of medicine Karl Blume, MD, Robert Negrin, MD, and professor of pathology Irving Weissman, MD, wondered if there was a way to overcome this problem. They opted to use antibodies that recognized newly identified markers on the surface of the blood stem cells to purify the stem cells away from regular blood and any roving cancer cells. They then used this purified population of stem cells in 22 women with metastatic breast cancer who enrolled in the trial from December 1996 to February 1998. Then they waited as the years passed.

Last year, Mueller and the research team began to compare the progression-free and overall survival of their experimental group to those of a group of 74 women who received identical chemotherapy treatments between February of 1995 and June of 1999 but who received unmanipulated, mobilized peripheral blood.

Results showed five of the 22 women (23 percent) who received the purified stem cells are still alive and four have no sign of disease. Their median overall survival was 60 months. In comparison, seven of the 74 women (9 percent) who received the untreated cells are living and five have no sign of disease. Their median overall survival was 28 months. While the overall numbers were small, researchers hope the results will spur the medical community to revisit using such aggressive treatment options for patients with metastatic breast cancer.

The Stanford Blood and Marrow Transplant group are currently planning a larger clinical trial of the treatment, although the details are still being finalized.

Previously: Stanford Women’s Cancer Center opens Monday, Partial breast irradiation could sidestep side effects of traditional radiation therapy, New breast cancer finding suggests limiting surgery and Stanford researchers find new marker to identify severe breast cancer cases

Ethics, In the News, Stem Cells

Bioethicist Arthur Caplan slams unproven stem cell clinics

As my colleague reported, the International Society for Stem Cell Research (ISSCR) has been forced to shutter the portion of its patient education website “A Closer Look at Stem Cells” that promised to investigate clinics offering stem cell treatments directly to patients. The reason? Threatened lawsuits from the very companies that the society hoped to investigate. Nature published a nice summary (subscription required) of the situation last month.

Today, bioethicist Arthur Caplan, PhD, sounds off about the shutdown in a commentary on MSNBC’s Breaking Bioethics blog:

As Heidi Ledford reported in the June 28 issue of Nature, the ISSCR, which facilitates the exchange of research between over, 3,500 scientists worldwide, has suspended its website intended to help patients wade through the more crackpot claims about stem cell therapies and clinics.

All the ISSCR was going to do was to post information on what published evidence existed about claims of cures, which providers had medical-ethics oversight committees and which complied with regulatory agencies such as Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Instead, some in the industry launched a barrage of legal threats at the ISSCR which, as a small scientific organization, felt it could not afford to fight even if, in the end, they would win.

This is sad. I’ve written before about how these clinics prey on desperate patients and parents, and why the ISSCR (under the then-leadership of Stanford stem cell expert Irving Weissman, MD) chose to create the website to help the public understand some basic facts and stem cells and the “therapies” these clinics claim to offer. Without any way to judge whether a clinic is reputable, I expect many more people will spend tens of thousands of dollars to pursue unproven and potentially dangerous experimental treatments. As Caplan, who directs the Center for Bioethics at the University of Pennsylvania,  concludes:

So, the stem cell ‘therapy’ industry — many of whom seem more concerned with their pocketbooks than with giving patients information — and some of whom are involved in medicine that is more voodoo than science have bullied their critics into submission. If you are sick or know someone with an incurable disease, keep this in mind when considering the real value of a trip overseas to find a miracle stem cell cure.

Previously: International stem cell group provides website for patients seeking stem cell treatments, Beware: Stem cell treatments offering “miracle” cures and Stem cell researchers challenge clinics’ questionable practices
Photo by Axel Schwenke

Clinical Trials, In the News, Stem Cells

Two new human embryonic stem cell trials launched

There is much news today about two human embryonic stem cell trials that were launched on Tuesday at UC Los Angeles. That brings to three the number of ongoing human clinical trials of the cells. (The Stanford School of Medicine is a participating site in the first trial - one run by Geron, Corp to test the safety of hESC-derived cells in patients with spinal cord injury – although we haven’t yet treated a patient.) Nature sums up the two new trials in this blog post today:

Now, the second and third hESC trials have been launched. On July 12, in an operating room at the University of California, Los Angeles, the first subject in each of the trials — one for a rare form of blindness that usually begins in childhood, the other for a common cause of blindness in the elderly — was treated with retinal pigment epithelial (RPE) cells derived from hESCs. [...] One of the conditions being treated, Stargardt’s Macular Dystrophy, it is a degenerative disease of the retina that affects roughly 1 in 10,000 US youngsters. The other, a closely related cause of blindness, Age-related Macular Degeneration (AMD), affects millions of Americans. (The trial therapy is attacking “dry” AMD, which account for about 90% of all AMD.)

Both of the two new trials are sponsored by Santa Monica-based Advanced Cell Technology, which announced the procedures this morning.

Previously: Stanford joins first human embryonic stem cell trial

Cancer, Neuroscience, Research, Stem Cells

Could stem cells help brain-cancer patients regain cognitive abilities?

A new study, to be published in Cancer Research on July 15, suggests that stem cells may be the key to restoring cognitive functions such as learning and memory after brain tumor treatment.

Radiation therapy can be highly effective in eliminating otherwise-deadly brain tumors, but rarely without taking a toll on neighboring healthy brain cells. As described in a release, neural radiation can cause patients’ IQs to drop by as many as three points per year.

For this study, researchers from UC Irvine transplanted stem cells into the brains of rats whose brains had undergone radiation two days prior. They measured the rats’ cognitive abilities several months later and found that 15 percent of the stem cells that had survived in the rats’ brains had developed into neurons, while another 45 percent of the cells had developed into equally crucial supporting glial cells. The stem-cell-treated rats exhibited restored brain function, while irradiated rats that didn’t receive the stem-cell treatment showed no improvement.

Radiation oncology professor Charles Limoli, PhD, says the next step would be to test this in humans:

While much work remains, a clinical trial analyzing the safety of such approaches may be possible within a few years, most likely with patients afflicted with glioblastoma multiforme, a particularly aggressive and deadly form of brain cancer.

Podcasts, Stem Cells

New stem cell podcast from UC Davis researcher

A post today from the California Institute for Regenerative Medicine’s blog, Research Results, caught my attention with the announcement that noted UC Davis stem cell researcher and CIRM grantee Paul Knoepfler, PhD, has added a podcast feature to his stem cell blog. According to CIRM communications manager Amy Adams:

Several organizations such as CIRM, the Canadian Stem Cell Network and the Australian Stem Cell Centre also have blogs that promote stem cell science and attempt to put recent scientific advances into context. However, to my knowledge Knoepfler is the only stem cell scientist attempting to reach the public online. I look forward to hearing more podcasts from Knoepfler, and wish him much success in providing accurate information about stem cell research at a time when it is so clearly needed.

I haven’t listened to it myself yet, but it looks like the first 16-minute-long podcast takes on stem cell tourism in the US (a particular interest of mine), recent goings-on at CIRM and, intriguingly ‘stem cell hype on aging’. I’m going to cue it up as soon I can coax my reluctant computer speakers to work again by employing my tried-and-true combination of a reboot plus cursing. If you hurry you can beat me to it.

Photo by Carbon Arc

Ethics, Health Policy, In the News, Stem Cells

Stem cell researchers challenge clinics’ questionable practices

Regenerative medicine such as stem cell therapy has cast a ray of hope into many patients’ lives. Stem cell clinics, however, do not always offer patients the most effective treatments. According to a recent Nature article:

Many of the treatments such clinics offer — injecting a patient’s own stem cells back into his or her body in a bid to treat conditions ranging from Parkinson’s disease to spinal-cord injuries — are at best a waste of money, and at worst dangerous. “There’s real potential to damage the legitimacy of the field,” says Timothy Caulfield, who studies health law and policy at the University of Alberta in Edmonton, Canada.

The potential danger of these clinics is clear: In May, Europe’s largest stem-cell clinic was shut down after its treatments were linked to a child’s death.

Some stem cell researchers are frustrated with these clinics’ proliferation and the FDA’s relatively lax regulation. Last June, the International Society for Stem Cell Research (ISSCR) launched a website dedicated to providing patients with fact-based, on-demand analysis of the treatments that these clinics offer. When the ISSCR approached clinics asking for information on their services, however, many cited their lawyers, challenging the society’s right to question them. The ISSCR, whose resources were too limited to risk litigation, backed down:

At the society’s annual meeting in Toronto, Canada, this month, Irving Weissman, a stem-cell researcher at Stanford University in California, turned to the audience for advice. “What should we do?” he asked. “Should we risk litigation?” The audience could not come to a consensus, and the programme is still on hold.

Researchers still seek a way to educate patients on the dangers of unproven treatments, worrying that in the meantime patients will seek information from unreliable sources or from societies with potential conflicts of interests due to close connections with the regenerative-medicine industry.

For additional reading, my colleague Krista Conger delved into this topic in a recent Stanford Medicine piece.

Previously: Beware: Stem cell clinics offering “miracle” cures, International Cellular Medicine Society evaluates overseas stem cell clinics, The cruelty of fraudulent stem cell therapies

Stanford Medicine Resources: