Tag Archives: stem cells

Stem cells: Hope or hype? #ahcj13

Lisa Krieger

About Lisa Krieger

Lisa Krieger is a science and medicine writer at the San Jose Mercury News. She is attending Health Journalism 2014 on an AHCJ-California Health Journalism Fellowship, which is supported by The California HealthCare Foundation.

The public’s hope for stem cell cures remain high, but scientists warn that many basic problems with this approach remain to be solved – and that investors demand profits far faster than research can be finished.

“We’ve created a system that is unrealistic and short sighted,” said Dr. Darrell Kotton, director of Center for Regenerative Medicine at Boston University’s Boston Medical Center.

Few of the 38 publicly traded stem cell companies will survive, said Philip Reilly, a physician, attorney and venture partner with Third Rock Ventures.

It is very difficult to produce returns in “venture time,” defined as less than five years, said Reilly. “There is tremendous disconnect,” between investors and biologists’ timelines, he said.

The best strategy, he believes, is for a small company to show data with enough promise – what he called “an inflection point” – that it wins the interest of a larger company, with the resources to carry the research across the finish line.

“Few will make it,” he said, of existing companies. At almost all, the cost per share has fallen below the opening price. “They were launched too soon.” Continue reading

Case could set precedent for regulating stem cells

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism, and he has blogged for Covering Health ever since.

On Forbes.com, Gergana Koleva digs deep into the ongoing court battle between Regenerative Sciences and the FDA over the question of whether stem cells “should be federally regulated as drugs.” While the treatment at issue isn’t generally a matter of life or death, the courts’ decisions in this case will have implications for other headline-grabbing stem cell treatments.

Human embryonic stem cells

(Photo: National Institutes of Health)

At the heart of the debate is a therapy that uses stem cells derived from bone marrow to repair damaged joints. It was developed in 2005 by the Colorado-based company, which began offering it to patients around 2007, and has since gathered a raft of clinical evidence and testimony about its safety and efficacy. The FDA is questioning its legality, alleging that the stem cells it uses are more than minimally manipulated drugs and should be regulated and subject to approval as drugs. In 2008, the agency accused Regenerative of practicing medicine without a license required for the introduction of a new drug, and in 2010 sued to stop it from performing the procedure.

Regenerative and its allies argue that, because the therapy re-injects a patient’s own cells, it creates, as Koleva writes, “fewer and less severe complications than the more invasive and costlier surgical procedures it helps many patients avoid.” For its part, the FDA calls the therapy unproven and not guaranteed to be safe. In the end, the FDA indicates, it boils down to semantics.

Regulators have argued that the Regenexx procedure is equivalent to the administration of a drug because the stem cells that are re-injected into patients constitute an “‘article’ that is intended to treat, cure, and mitigate diseases and to affect the structure and function of the patient’s body,” therefore fitting within the definition of “drug.”

Society ‘snookered’ by research that isn’t new

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

Peggy Peck of MedPage Today found that research presented as new at the European Society of Cardiology’s annual meeting this weekend was actually published in July, despite the society’s requirement that information submitted for presentation must be new, unpublished data.

When asked by MedPage Today to point out the “news” in the Hot Line presentation, STAR lead investigator Bodo-Eckehard Strauer, MD, of the Heinrich Heine University of Düsseldorf, Germany, said the news was that bone marrow cell therapy significantly improved survival in patients with chronic cardiomyopathy, which he illustrated with a slide showing a Kaplan-Meier curve – the same graph that was published in the July issue of the European Journal of Heart Failure. Moreover, every data slide in Strauer’s presentation matched the tables in the published paper.

Following questions from MedPage Today, the organization acknowledged its error and has announced the researcher will not be allowed to present at its meetings for two years. Roberto Ferrari, M.D., president of the society, said the research had been accepted for presentation because they thought it had new data but that “We were snookered.”

Ruling puts stem cell research on hold

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

A federal judge’s ruling has, at least temporarily, blocked efforts to expand stem cell research, based on a decision that says “regulations designed to expand federal funding for embryonic stem cell research violated a law [the Dickey Wicker Amendment] prohibiting destruction of embryos for research purposes.”

When stem cells like these human embryonic stem cells divide, each new cell has the potential to remain a stem cell or become a cell with a more specialized function, such as a muscle cell or a red blood cell. Photo: National Institutes of Health

When stem cells like these human embryonic stem cells divide, each new cell has the potential to remain a stem cell or become a cell with a more specialized function, such as a muscle cell or a red blood cell. Photo: National Institutes of Health

It’s yet to be determined what the implications of this ruling [PDF] will be if it stands, but it could affect millions of dollars of federally-funded research. AHCJ has some background and links to help reporters who might be looking at how this will affect local researchers.

NIH rules more stem cells eligible for funding

Scott Hensley

About Scott Hensley

Scott Hensley runs NPR's online health channel, Shots. Previously he was the founding editor of The Wall Street Journal's Health Blog and covered the drug industry and the Human Genome Project for the Journal. Hensley serves on AHCJ's board of directors. You can follow him at @ScottHensley.

Right off the bat let’s just note that the promised cures from stem cells have been slow in coming.

Science is hard. But many researchers trying to harness embryonic stem cells, which have the potential to produce any kind of cell in the human body, say restrictions on the cells that qualify for federal funding have made the work even harder. (AHCJ article – Covering stem cells: Background on science, politics and global competition)

Human embryonic stem cellsWhen stem cells like these human embryonic stem cells divide, each new cell has the potential to remain a stem cell or become a cell with a more specialized function, such as a muscle cell or a red blood cell. Photo: National Institutes of Health

Earlier this year the Obama administration rolled back limits from the Bush era that restricted federal funding to only a few cell lines. But it still hasn’t been clear which stem cells are OK and which are verboten.

The National Institutes of Health has waded in with clarifying guidelines that take effect today. The upshot: if the old cell lines were created ethically, then they should be good to go. The main issue is whether researchers got the appropriate consent of donors.

Next up, an NIH committee will pass judgment on existing cells and produce a Web site itemizing the ones that are legit.

“Every institution shouldn’t have to rediscover which cell lines are eligible for NIH funding, so having a registry is very practical,” George Q. Daley, a stem-cell researcher at Children’s Hospital Boston told The New York Times.

AHCJ resourcesCovering stem cells: Background on science, politics and global competition

Tip Sheet: Stem cell research in California

Intense competition in stem cell research: Mark Johnson of the Milwaukee Journal Sentinel writes a three-part series detailing the discovery of how to create embryonic stem cells out of normal cells. The online package includes a time-lapse video of an embryo’s first five days of development and links to a discussion about the ethics of stem cell research.

Obama order expected to increase speed, efficiency of stem cell research

National Center for Biotechnology Information

Medical Advances: Treatments, Cures, Possibilities: Presentations from this Knight Center for Specialized Journalism seminar are available.

NY stem cell researchers can pay egg donors

Scott Hensley

About Scott Hensley

Scott Hensley runs NPR's online health channel, Shots. Previously he was the founding editor of The Wall Street Journal's Health Blog and covered the drug industry and the Human Genome Project for the Journal. Hensley serves on AHCJ's board of directors. You can follow him at @ScottHensley.

The ethical thicket that is stem cell research just got a little more complex. New York became the first state to allow taxpayer-funded researchers to pay women to donate eggs specifically for stem cell experiments.

“Stripped” human oocyte; granulosa cells that had surrounded this oocyte have been removed. Courtesy: RWJMS IVF Laboratory via Wikimedia Commons

The compensation could run as high as $10,000. Supporters argue it will spur better, quicker research results. Opponents say paying for eggs crosses an ethical line.

The state board that made the new policy says it’s just like compensating women for donating eggs for reproductive purposes. But the National Academy of Sciences doesn’t see it that way, saying in its guidelines for stem cell research that payment to donors for eggs is a no-no.

Some scientists in the field say the main source now — eggs left over from in vitro fertilization procedures — hasn’t been adequate. (New York won’t pay for those eggs under the new policy anyway.)

Scientists outside New York are already envious. Harvard stem cell researcher George Q. Daley, told The New York Times, the payment policy “will mean a tremendous advantage” for labs in New York.

Obama order expected to increase speed, efficiency of stem cell research (#ahcj09)

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

On the same day that Health Journalism 2009 featured a panel on “Second wind for stem cell research,” The National Institutes of Health issued draft guidelines to allow government funding for stem cell research.

Lawrence Goldstein, Ph.D., a stem cell researcher with the University of California San Diego and a member of the board of the International Society for Stem Cell Research, and Chuck Murry, M.D., Ph.D., co-director of the University of Washington’s Institute for Stem Cell and Regenerative Medicine, commented on the executive order, as well as on the chilling effects of President Bush’s order that limited stem cell research.

Read about what the researches said about the order and the future of stem cell research.

CJR: Be skeptical of miraculous study results

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism, and he has blogged for Covering Health ever since.

In the Columbia Journalism Review, Katherine Bagley urges journalists to use caution when reporting the results of medical studies, citing reports on a recent study on the effectiveness of using stem cells to halt or even reverse multiple sclerosis as an example.

Done with caution and a critical eye, coverage of limited but promising research can provide a needed dose of optimism for people with MS and their families. Unfortunately, in this case, that journalistic prudence was almost totally missing.

Bagley said that, through over-the-top reporting and selective coverage of the small-scale control-free study had inspired false hope and misled readers.

Covering Obama’s stance on stem cell research

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

President Barack Obama is expected today to overturn the Bush-era policy that restricted federal funding of embryonic stem cell research. In his official agenda that lays out his positions on issues, Obama said he would “support increased stem cell research. Allow greater federal government funding on a wider array of stem cell lines.”

Human embryonic stem cells
When stem cells like these human embryonic stem cells divide, each new cell has the potential to remain a stem cell or become a cell with a more specialized function, such as a muscle cell or a red blood cell.
Photo: National Institutes of Health

Terri Somers of The San Diego Union-Tribune wrote an article for AHCJ about covering stem cells that includes background on the science, politics and global competition of stem cell research. AHCJ also has a presentation from Zach W. Hall, former president of the California Institute for Regenerative Medicine, that looks at stem cell research in that state. And Al Tompkins at the Poynter Institute provides some background and links on stem cells.

According to Chris Cillizza of The Washington Post, Obama will sign an executive order that will allow study of a broader group of stem cell lines. Cillizza looks at some of the politics surrounding the issue, as well as polls that attempt to measure Americans’ position on stem cell research. The New York Times reports that Obama is leaving some of the more difficult questions about stem cell research to Congress to resolve, such as “whether taxpayer dollars should be used to experiment on embryos.”

Arthur Caplan, Ph.D., director of the Center for Bioethics at the University of Pennsylvania, writes that “This reversal of former President George W. Bush’s ban on such funding is good news for the science needed to find treatments for currently incurable conditions and for the ethics at stake in the issue.”