Every day we get a call from someone seeking help. Some are battling a life-threatening or life-changing disease. Others call on behalf of a friend or loved one. All are looking for the same thing; a treatment, better still a cure, to ease their suffering.
Almost every day we have to tell them the same thing; that the science is advancing but its not there yet. You can almost feel the disappointment, the sense of despair, on the other end of the line.
If its hard for us to share that news, imagine how much harder it is for them to hear it. Usually by the time they call us they have exhausted all the conventional therapies. In some cases they are not just running out of options, they are also running out of time.
Chasing hope
Sometimes people mention that they went to the website of a clinic that was offering treatments for their condition, claiming they had successfully treated people with that disease or disorder. This week I had three people mention the same clinic, here in the US, that was offering them treatments for multiple sclerosis, traumatic brain injury and chronic obstructive pulmonary disease (COPD). Three very different problems, but the same approach was used for each one.
Its easy to see why people would be persuaded that clinics like this could help them. Their websites are slick and well produced. They promise to take excellent care of patients, often helping take care of travel plans and accommodation.
Theres just one problem. They never offer any scientific evidence on their website that the treatments they offer work. They have testimonials, quotes from happy, satisfied patients, but no clinical studies, no results from FDA-approved clinical trials. In fact, if you explore their sites youll usually find an FAQ section that says something to the effect of they are not offering stem cell therapy as a cure for any condition, disease, or injury. No statements or implied treatments on this website have been evaluated or approved by the FDA. This website contains no medical advice.
What a damning but revealing phrase that is.
Now, it may be that the therapies they are offering wont physically endanger patients though without a clinical trial its impossible to know that but they can harm in other ways. Financially it can make a huge dent in someones wallet with many treatments costing $10,000 or more. And there is also the emotional impact of giving someone false hope, knowing that there was little, if any, chance the treatment would work.
Shining a light in shady areas
U.C. Davis stem cell researcher, CIRM grantee, and avid blogger Paul Knoepfler, highlighted this in a recent post for his blog The Niche when he wrote:
Paul Knoepfler
Patients are increasingly being used as guinea pigs in the stem cell for-profit clinic world via what I call stem cell shot-in-the-dark procedures. The clinics have no logical basis for claiming that these treatments work and are safe.
As the number of stem cell clinics continues to grow in the US and morephysicians add on unproven stem cell injections into their practices as a la carte options, far more patients are being subjected to risky, even reckless physician conduct.
As if to prove how real the problem is, within hours of posting that blog Paul posted another one, this time highlighting how the FDA had sent a Warning Letter to the Irvine Stem Cell Treatment Center saying it had serious concerns about the way it operates and the treatments it offers.
Paul has written about these practices many times in the past, sometimes incurring the wrath of the clinic owners (and very pointed letters from their lawyers). Its to his credit that he refuses to be intimidated and keeps highlighting the potential risks that unapproved therapies pose to patients.
Making progress
As stem cell science advances we are now able to tell some patients that yes, there are promising therapies, based on good scientific research, that are being tested in clinical trials.
There are not as many as we would like and none have yet been approved by the FDA for wider use. But those will come in time.
For now we have to continue to work hard to raise awareness about the need for solid scientific evidence before more people risk undergoing an unproven stem cell therapy.
And we have to continue taking calls from people desperate for help, and tell them they have to be patient, just a little longer.
***
If you are considering a stem cell treatment, the International Society for Stem Cell Research had a terrific online resource, A Closer Look at Stem Cells. In particular, check out the Nine Things to Know about Stem Cell Treatments page.
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Guest Author Geoff Lomax is CIRMs Senior Officer for Medical and Ethical Standards.
In the spirit of Stem Cell Awareness Day, Cell Stem Cell has compiled a Public Interest collection of articles covering ethical, legal, and social implications of stem cell research and made it freely available. The collection may be found here.
The collection covers issues ranging from research involving human embryos to the use of stem cell therapies in patients. For those of you interested in a good primer on the history of stem cell controversies, Herbert Gottweis provides a detailed review of the federal policy debate in the United States. This debate has resulted in inconsistent policy and disrupted research. Gottweis uses this history to support his message that a comprehensive, and proactive policy approach in this field beyond the quick legal fix is needed for patients to ultimately benefit from the science.
What I found most interesting about this collection was the focus on stem cell treatments and tourism. A majority of the articles address the use of stem cells in patients. This focus is an indicator of how far the field has progressed. Stem cells clinical trials are now a reality and this results in two separated but related considerations. First, is how to make sure prospective patients are well informed should they participate in a clinical trial. Second, how to avoid stem cell snake oil where someone is pitching an unproven procedure. These issues are related by their solution that involves empowerment and education of patients and their support networks.
For example, in Stem Cell Tourism and Public Education: The Missing Elements, Master writes:
It is important for the scientific, medical, ethics, and policy communities to continue to promote accurate patient and public information on stem cell research and tourism and to ensure that it is effectively disseminated to patients by working alongside patient advocacy groups.
Masters team found that groups committed to the advancement of good science, including patient advocates and researchers, often lacked basic information about clinical trials and other options for patients. This lack of information may contribute to patients being wooed by those pitching unproven procedures. Thus, the research community should continue to work with patients and advocacy organizations to identity options for treatment.
Another aspect of patient empowerment is what Insoo Huyn refers to as therapeutic hope in his piece: Therapeutic Hope, Spiritual Distress, and the Problem of Stem Cell Tourism. Huyn suggests that a supportive system for delivering cell therapies should includes nurturing hope. He writes, patients might understand when an interventions chances of success are extremely remote at best, but may still want to give it a shot as long as a beneficial outcome cannot be ruled out as categorically impossible. Huyn recognizes that well developed early-stage clinical trials are not expected to provide a benefit to patients (they are designed to evaluate safety), but the nature of the therapeutic (often cells) means there may be some real effect.
A third piece by the ISSCR Ethics Taskforce titled Patients Beware: Commercialized Stem Cell Treatments on the Web presents a guide to evaluating therapies. They present five principles that patients, researchers and advocates can rally around to identify credible interventions. The taskforce states:
The guiding principles for the development of the recommended process were that (1) the standards for identifying and reviewing clinics and suppliers should be objective and clear; (2) the inquiry and review process should be publicly transparent and relatively straight- forward for any clinic or practitioner to comply with; (3) conflicts of interest, if any, of the declarant ought to be disclosed to the ISSCR; (4) there should be no actual or apparent conflicts of interest of staff or others involved in the inquiry or review process for any particular matter; and (5) any findings that a clinic fails to meet standards should be communicated in a specific factual way, rather than with broad conclusions of fraudulent practices.
While the Cell Stem Cell Public Interest series covers a range of issues related to stem cells and society, the emphasis on treatments and patients is a reminder of how far the field has come. There is broad consensus that patients, researchers and advocates have roles to play in advancing safe and effective cell therapies.
Geoff Lomax
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Here are some stem cell stories that caught our eye this past week. Some are groundbreaking science, others are of personal interest to us, and still others are just fun.
The zebrafish (Danio rerio) owes its name to a repeating pattern of blue stripes alternating with golden stripes. [Credit: MPI f. Developmental Biology/ P. Malhawar]
How the Zebrafish Got its Stripes. Scientists in Germany have identified the different pigment cells that emerge during embryonic development and that determine the signature-striped pattern on the skins of zebrafishone of sciences most commonly studied model organisms. These results, published this week in the journal Science, will help researchers understand how patterns, from stripes to spots to everything in between, develop.
In the study, scientists at the Max Planck Institute for Developmental Biology mapped how three distinct pigment cells, called black cells, reflective silvery cells, and yellow cells emerge during development and arrange themselves into the characteristic stripes. While researchers knew these three cell types were involved in stripe formation, what they discovered here was that these cells form when the zebrafish is a mere embryo.
We were surprised to observe such cell behaviors, as these were totally unexpected from what we knew about color pattern formation, says Prateek Mahalwar, first author of the study, in a news release.
What most surprised the research team, according to the news release, was that the three cell types each travel across the embryo to form the skin from a different direction. According to Dr. Christiane Nsslein-Volhard, the studys senior author:
These findings inform our way of thinking about color pattern formation in other fish, but also in animals which are not accessible to direct observation during development such as peacocks, tigers and zebras.
Sound Waves Dispense Individual Stem Cells. It happens all the time in the lab: scientists need to isolate and study a single stem cell. The trick is, how best to do it. Many methods have been developed to achieve this goal, but now scientists at the Regenerative Medicine Institute (REMEDI) at NUI Galway and Irish start-up Poly-Pico Technologies Ltd. have pioneered the idea of using sound waves to isolate living stem cells, in this case from bone marrow, with what they call the Poly-Pico micro-drop dispensing device.
Poly-Pico Technologies Ltd., a start-up that was spun out from the University of Limerick in Ireland, has developed a device that uses sound energy to accurately dispense protein, antibodies and DNA at very low volumes. In this study, REMEDI scientists harnessed this same technology to dispense stem cells.
These results, while preliminary, could help improve our understanding of stem cell biology, as well as a number of additional applications. As Poly-Pico CEO Alan Crean commented in a news release:
We are delighted to see this new technology opportunity emerge at the interface between biology and engineering. There are other exciting applications of Poly-Picos unique technology in, for example, drug screening and DNA amplification. Our objective here is to make our technology available to companies, and researchers, and add value to what they are doing. This is one example of such a success.
The Dangers of Stem Cell Toursim. Finally, a story from ABC News Australia, in which they recount a womans terrifying encounter with an unproven stem cell technique.
In this story, Annie Levington, who has suffered from multiple scleoris (MS) since 2007, tells of her journey from Melbourne to Germany. She describes a frightening experience in which she paid $15,000 to have a stem cell transplant. But when she returned home to Australia, she saw no improvement in her MSa neuroinflammatory disease that causes nerve cells to whither.
They said I would feel the effects within the next three weeks to a year. And nothing I had noticed nothing whatsoever. [My neurologist] sent me to a hematologist who checked my bloods and concluded there was no evidence whatsoever that I received a stem cell transplant.
Sadly, Levingtons story is not unusual, though it is not as dreadful as other instances, in which patients have traveled thousands of miles to have treatments that not only dont cure they conditionthey actually cause deadly harm.
The reason that these unproven techniques are even being administered is based on a medical loophole that allows doctors to treat patients, both in Australia and overseas, with their own stem cellseven if that treatment is unsafe or unproven.
And while there have been some extreme cases of death or severe injury because of these treatments, experts warn that the most likely outcome of these untested treatments is similar to Levingtonsyour health wont improve, but your bank account will have dwindled.
Want to learn more about the dangers of stem cell tourism? Check out our Stem Cell Tourism Fact Sheet.
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One of the big concerns among scientists including many at the International Society for Stem Cell Research (ISSCR) conference in Vancouver, Canada is that patient expectations about stem cells are often greater than researchers are able to deliver today. That can result in patients in search of a cure heading to overseas clinics that offer unproven therapies.
Megan Munsie head of the Education, Ethics, Law and Community Awareness Unit at the University of Melbourne in Australia wanted to find out what happens when patients hopes for new treatments come into conflict with scientific views on medical evidence. So she started with a small survey of 16 Australians, patients and patient-caretakers, who had travelled outside Australia for stem cell treatments for a variety of diseases including MS and cerebral palsy.
She says there were a number of interesting findings:
Perhaps the most surprising finding was that all of them talked about the benefits they gained from going abroad for the treatment, that it gave them a sense of hope even if there was no evidence of medical benefit.
What happens when patients hopes for new treatments come into conflict with scientific views on medical evidence?
This led to a bigger study where Munsie surveyed patients and patient advocates but also stem cell scientists and physicians. Not surprisingly the researchers had a very different view of the subject than the patients.
Researchers/doctors said they felt that patients dont understand science and dont appreciate the subtleties of clinical trials
What was interesting, however, is that many doctors said they didnt try to persuade their patients not to go, instead they chose to respect their autonomy but did at least try to give them the facts so that they could make a decision based on knowledge not ignorance.
When asked why they didnt tell patients not to go, they said they respected the patients need for hope and didnt want to take that away from them because they had nothing they could offer to replace it.
Munsie says recently some doctors have started offering these kinds of unproven therapies in Australia. She talked to four of them asking how they could justify it. All four said there is a huge unmet medical need and it was better to offer these therapies in Australia than have patients travel to other countries for them. They also said that they felt competent to provide treatment because they had undergone some kind of training or had a license to use equipment needed for the therapy.
Ironically while they all considered themselves legitimate providers of a needed medical therapy albeit an unproven one and only interested in the science, they regarded others doing the same as cowboys and only interested in the money.
When asked if they would support more regulation of the kinds of therapies they were already offering they said yes, saying that the other doctors who claimed they were self-regulating is like giving the keys to the asylum to the lunatics.
Munsie says its clear that its not just patients who could benefit from some guidance on expectations about stem cell therapies.
She says we need to do a better job of managing patient expectations without robbing them of a sense of hope, perhaps by offering them information that is more tailored to their particular needs.
We also need to manage what she called the unbridled enthusiasm of providers who are offering speculative treatments as medical practice. That might take regulatory change by the government.
She says its difficult to strike a balance between hope and scientific evidence, in maintaining a patients sense of optimism while acknowledging the reality of the science and the risks posed by unproven treatments.
Kevin McCormack
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One of the big concerns among scientists including many at the International Society for Stem Cell Research (ISSCR) conference in Vancouver, Canada is that patient expectations about stem cells are often greater than researchers are able to deliver today. That can result in patients in search of a cure heading to overseas clinics that offer unproven therapies.
Megan Munsie head of the Education, Ethics, Law and Community Awareness Unit at the University of Melbourne in Australia wanted to find out what happens when patients hopes for new treatments come into conflict with scientific views on medical evidence. So she started with a small survey of 16 Australians, patients and patient-caretakers, who had travelled outside Australia for stem cell treatments for a variety of diseases including MS and cerebral palsy.
She says there were a number of interesting findings:
Perhaps the most surprising finding was that all of them talked about the benefits they gained from going abroad for the treatment, that it gave them a sense of hope even if there was no evidence of medical benefit.
What happens when patients hopes for new treatments come into conflict with scientific views on medical evidence?
This led to a bigger study where Munsie surveyed patients and patient advocates but also stem cell scientists and physicians. Not surprisingly the researchers had a very different view of the subject than the patients.
Researchers/doctors said they felt that patients dont understand science and dont appreciate the subtleties of clinical trials
What was interesting, however, is that many doctors said they didnt try to persuade their patients not to go, instead they chose to respect their autonomy but did at least try to give them the facts so that they could make a decision based on knowledge not ignorance.
When asked why they didnt tell patients not to go, they said they respected the patients need for hope and didnt want to take that away from them because they had nothing they could offer to replace it.
Munsie says recently some doctors have started offering these kinds of unproven therapies in Australia. She talked to four of them asking how they could justify it. All four said there is a huge unmet medical need and it was better to offer these therapies in Australia than have patients travel to other countries for them. They also said that they felt competent to provide treatment because they had undergone some kind of training or had a license to use equipment needed for the therapy.
Ironically while they all considered themselves legitimate providers of a needed medical therapy albeit an unproven one and only interested in the science, they regarded others doing the same as cowboys and only interested in the money.
When asked if they would support more regulation of the kinds of therapies they were already offering they said yes, saying that the other doctors who claimed they were self-regulating is like giving the keys to the asylum to the lunatics.
Munsie says its clear that its not just patients who could benefit from some guidance on expectations about stem cell therapies.
She says we need to do a better job of managing patient expectations without robbing them of a sense of hope, perhaps by offering them information that is more tailored to their particular needs.
We also need to manage what she called the unbridled enthusiasm of providers who are offering speculative treatments as medical practice. That might take regulatory change by the government.
She says its difficult to strike a balance between hope and scientific evidence, in maintaining a patients sense of optimism while acknowledging the reality of the science and the risks posed by unproven treatments.
Kevin McCormack
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See more here:
stem cell tourism | The Stem Cellar
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