Tag: stem cell research

Blog Posts (21)

November 23, 2014

Deregulation and Free Markets for Stem Cell Products

<p class="MsoNoSpacing" style="line-height: 19.0400009155273px;"><span style="line-height: 19.0400009155273px;">Paolo Bianco and colleague Douglas Sipp wrote a very provocative and interesting piece recently published in the journal</span><em style="line-height: 19.0400009155273px;">Nature</em><span style="line-height: 19.0400009155273px;"> (</span><a style="line-height: 19.0400009155273px;" href="http://www.nature.com/news/regulation-sell-help-not-hope-1.15409">http://www.nature.com/news/regulation-sell-help-not-hope-1.15409</a><span style="line-height: 19.0400009155273px;">)discussing a movement to permit stem cell medicines, among others, to be sold in the market without the requirement to show much safety and efficacy data permitting the market to determine safety and effectiveness of compounds. Here, patients would basically pay to obtain products and also be research subjects. Certain powerful groups are calling for the deregulation of clinical medicine as a business model to bring innovative products to the marketplace. But before I begin explaining what Bianco and Sipp discuss, we need to cover the current system of regulatory oversight of medical products.</span></p> <p class="MsoNoSpacing" style="line-height: 19.0400009155273px;"><strong style="line-height: 19.0400009155273px; color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px;">The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our <a style="color: #000099; text-decoration: underline;" href="/Academic/bioethics/index.cfm">website</a>.</strong></p>
September 2, 2014

Holding Institutions Responsible for Research Misconduct: the recent case of a death of stem cell scientist

<p class="MsoNoSpacing"><span>Scientist Yoshiki Sasai, age 52, committed suicide and was found dead on August 5, 2014. Sasai was deputy director of the Center for Developmental Biology (CDB) at RIKEN in Kobe, Japan, and coauthor on two recently retracted <em>Nature </em>papers about an easier way to make induced pluripotent stem cells. The papers were retracted due to duplication and manipulation of images done by the main researcher and lead author on the two papers – Haruko Obokata. Although cleared of any direct involvement, Sasai was under immense pressure and heavily scrutinized by the media, public and peers. This involved speculation about Sasai’s intentions to orchestrate a media frenzy, and for being overly ambitious and motivated to win future grants overlooking the integrity of the science.</span></p> <p class="MsoNoSpacing">According to colleagues at RIKEN, Sasai was receiving counseling since the scandal broke headlines and he was also hospitalized for about a month in March (1). He was found hanging in a stairwell of a neighboring building and beside him were three letters addressed to CDB management, his laboratory, and Obokata. On August 12, Kazuhiro Nakamura, the family lawyer explained the contents of Sasai’s suicide note left for the family. Sasai was “worn out by the unjust bashing in the mass media and the responsibility he felt towards RIKEN and his laboratory” (2). But unsubstantiated claims in the media were not the only source of stress for Sasai. The speculation in tabloids might have also influenced how RIKEN and other colleagues behaved towards Sasai. In June, a report released by an independent RIKEN reform committee criticized CDB leaders for hyping the science and did not interview Sasai about such accusations. Their final recommendation was to dismantle CDB. According to the family lawyer, this was a tremendous shock for Sasai (2).</p> <p class="MsoNoSpacing"><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 20px;">The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our <a style="color: #000099; text-decoration: underline;" href="/Academic/bioethics/index.cfm">website</a>.</strong><span style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 20.399999618530273px;"> </span></p>
April 2, 2014

Another Scandal Rocks the Stem Cell World

<p>The scientific and medical potential of stem cells hold so much promise that progress in this area is widely followed with intense interest. Since pluripotent stem cells are able to differentiate into any cell type they hold the promise of leading to therapies for a wide variety of diseases and disabilities which cause human suffering and end lives prematurely. This field of research and development has attracted the efforts of large numbers of the most brilliant and talented biomedical researchers in the entire world. This raises the vexing question of why some of these brilliant and talented researchers are doing some very stupid things.</p> <p class="MsoNormal">It seems like only yesterday (it was actually in 2004 and 2005) that Hwang Woo-Suk a renowned Korean veterinarian and researcher published the first reports in Science Magazine of the derivation of pluripotent stem cells from human embryos and subsequently the successful cloning of human embryonic stem cells. Hwang was a national hero. However these studies were recognized in 2006 as being the result of fraud.  I remember wondering then, just as I am wondering now, how someone could risk all that they had earned by committing such blatant fraud. How could they not realize that misconduct in such important work would be discovered and punished. I do not get it.</p> <p class="MsoNormal"><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 20px;">The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our <a style="text-decoration: underline; color: #000099;" href="/Academic/bioethics/index.cfm">website</a>.</strong></p>
March 30, 2014

Stem Cell Tourism & Education

<p class="MsoNoSpacing"><span>I have written on this blog about the topic of stem cell tourism and the different strategies that have been proposed to stop the phenomenon. Just to provide a background on the topic from a previous blog: stem</span> cell tourism is used to describe an internet-based direct-to-consumer advertised industry where clinics offer untested and unproven stem cell interventions as bonafide therapies to patients with a range of diseases and injuries including Parkinson’s disease, multiple sclerosis, ALS, blindness, cancer, cerebral palsy, spinal cord injury and many others. Basically there is no scientific evidence of safety of efficacy of these modalities to offer them on a for-profit basis to patients. The term was originally coined as a form of tourism because patients traveled from countries like the U.S., U.K., Canada and Australia to clinics in countries with lax regulations, but this simply is not the case anymore. There are several clinics within highly regulated countries like U.S. that offer stem cell interventions.</p> <p class="MsoNoSpacing">Of the several strategies people have discussed, one of the first has been on the topic of providing education to patients and the public. Here, people argue that providing education on the dangers of stem cell tourism might actually sway patients to not undertake unproven stem cell interventions. As some scholars have mentioned, education might not be as effective because it depends on a “rationale actor model” where we assume that patients will behave rationally and make choices based on weighing the harms and benefits of seeking unproven treatments. More so, such an argument does not sufficiently consider the hope patients have to ameliorate their disease, reduce pain or other symptoms, and increase their quality of life. While these counterarguments are certain rational and likely to be true, there is yet no solid evidence showing whether education on stem cell tourism is effective at swaying people from traveling for unproven interventions. But even if before we go into whether education might influence a patient’s decision to travel for unproven stem cell treatments, I think we need to assess the role of patient education in medicine.</p> <p class="MsoNoSpacing"><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 20px;">The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our <a style="text-decoration: underline; color: #000099;" href="/Academic/bioethics/index.cfm">website</a>.</strong></p>
October 5, 2011

Happy Stem Cell [Awareness] Day!

There is a day for virtually everything these days. Forget the old school Valentine’s and Sweetest Day, or even Administrative Professional’s or Grandparents’ Day.…

February 4, 2011

Caplan Discusses Ghosts of Bioethics' Present, Past and Future

On Point of Inquiry, Art Caplan discusses how bioethics has “come of age” and what questions are likely to engage the field in the future.…

November 18, 2010

Moreno Delves Deeper into Bush and Kass' "Decision Points"

Fascinated by Bush’s moral reasoning when it came to his stem cell decision of August 9th, 2001, Jonathan Moreno delves even deeper into the passages of the former president’s autobiography to explore the faulty logic of his position regarding embryonic stem cell research.…

November 10, 2010

Glenn McGee Was Right: It was Leon Kass' "Decision Point"

For those of you who will not be reading former President George W. Bush’s autobiography, Decision Points (I am among them), the National Journal has pulled out some choice selections of those items that might not make the headlines.…

September 1, 2010

McGee: Back on the Embryonic Stem Cell Merry-Go-Round, But Going In A New Direction

On the Bioethics Channel, Dr. Glenn McGee, the John B. Francis Chair in Bioethics at the Center for Practical Bioethics, stakes out his own position regarding the recent U.S.…

August 25, 2010

Caplan: America's Sick Deserve Better

Many have called it legislating from the bench. Others have called it sending us back to the stone age. But as Arthur Caplan puts it in this week’s MSNBC column Judge Royce Lamberth’s ruling preventing the use of federal funding for embryonic stem cell research hasn’t just hobbled stem cell research–it has killed the hopes for recovery of tens of thousands if not millions of Americans.…

View More Blog Entries

News (6)

November 14, 2012 3:50 pm

Stem Cell Finding Could Advance Immunotherapy for Lung Cancer (Science Daily)

A University of Cincinnati (UC) Cancer Institute lung cancer research team reports that lung cancer stem cells can be isolated — and then grown — in a preclinical model, offering a new avenue for investigating immunotherapy treatment options that specifically target stem cells.

June 1, 2012 8:58 am

Another Korean Stem Cell Study Scandal (First Things)

At the height of the great Embryonic Stem Cell Hype, Hwang Woo-suk fraudulently claimed to have created human cloned embryos and derived stem cells therefrom. He paid a price in reputation but not his freedom, despite obtaining research grants under false pretenses. Now, another Korean stem cell scientist stands accused of falsifying research reports.

May 31, 2012 11:43 am

Did the California stem cell program promise miracle cures? (Los Angeles Times)

You be the judge. Alan Trounson and Jonathan Thomas, the president and chairman of California’s stem cell program, have taken issue with how I characterized their program in a column this week. I pointed out that its founding 2004 initiative, Proposition 71, “was sold to a gullible public via candy-coated images of Christopher Reeve walking again and Michael J. Fox cured of Parkinson’s.”

May 14, 2012 11:14 am

Michigan lawmakers have no business meddling in stem cell research (AnnArbor.com)

If there was any serious question in Michigan whether stem cell research is a valuable and morally acceptable means of advancing medical science, it was resolved in 2008 when voters approved a constitutional amendment that allows researchers to create embryonic stem cell cultures and use them in medical research. The people of Michigan understood that embryos used in this form of research would be discarded otherwise, and the potential benefit to human health is too great to shut down such promising avenues of study. Unfortunately, there are lawmakers who would defy the will of the people by attacking stem cell research through backdoor means.

May 7, 2012 11:17 am

NY medical schools chart progress with stem cells (New York Times)

Almost halfway through a $600 million state program supporting stem cell research, eight medical schools around New York are reporting progress on projects such as replicating liver cells and eradicating leukemia cells. A new report from Associated Medical Schools of New York updates work at the institutions where hundreds of researchers are starting to unravel causes and potential treatments for conditions ranging from autism to heart disease and cancer.

May 2, 2012 11:14 am

South Korea steps up stem-cell work (Nature)

South Korea has been trying to restore its tarnished image in the field after the fall of one of its stellar stem-cell scientists, Woo Suk Hwang, who was convicted in 2009 for embezzlement and bioethics violations after falsifying results. The country has begun to regain confidence from a series of successful research projects, and is ranked in the world’s top ten for stem-cell and regenerative medicine research in terms of number and quality of publications. The South Korean government thinks that the country can be a top global competitor if the field is given enough support.