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“If You See Something, Say Something”
Cell Stem Cell
Editorial ‘‘If You See Something, Say Something’’ The ISSCR Annual Meeting in June was packed to the gills with interesting talks. Many of these were about science, and they were a great way to get updated about how leaders in the field are thinking about a broad range of issues. But ISSCR 2016 gave us more than that as well: a call to action. During the Saturday morning session, the prominent University of Wisconsin ethicist Alta Charo spoke about translational applications of genome editing and the lessons we can learn from ‘‘stem cell tourism.’’ Alta outlined her perspective that the scientific community has to a significant extent missed the boat on speaking up about and trying to counteract misleading claims by stem cell clinics that have led patients to, at best, spend money on treatments that have unknown effects and, at worst, do something that causes them actual harm. The recent example of Jim Gass, as reported in the New York Times (Kolata, 2016), who has a mass in his spine caused by stem cell transplantation he received outside the US, was fresh in our minds. Since the meeting, we’ve also heard about Sheila Drysdale, who passed away after a stem cell treatment in Australia (Arnold, 2016). And, as is evident from the articles we have in this issue from Turner and Knoepfler, focusing on the US, and from Rasko et al., with a more global perspective, this is not just a problem that happens ‘‘somewhere else.’’ It’s an issue even in countries with strong regulatory systems that pride themselves on providing high-quality medical care. Alta’s focus for her talk was on using the lessons from past experience to prompt more proactive action as genome editing starts to become a new ‘‘magic word,’’ but I would also argue that there’s still time and space for us to apply her suggestions to the stem cell arena as well. Of course this is not a new topic. Many in the scientific and medical communities have been highlighting it for some time, through presentations at meetings, journal articles, and interviews with the mainstream media, but that evidently hasn’t been enough to stem the tide. The ISSCR has also taken a proactive stance by putting together their ‘‘A Closer Look at Stem Cells’’ website (ISSCR, 2015), an online resource to help patients navigate the overall landscape and make informed decisions about which healthcare options they choose. They have also provided a comprehensive set of guidelines about responsible clinical translation covering the conduct of research and clinical trials and encouraging the community to speak up when something seems amiss (ISSCR, 2016). Another scientific organization, the ISCT, has issued its own set of guidelines about unproven treatments as well (ISCT, 2015). We do need to be mindful of the important balance that society has to strike between providing appropriate safeguards and supporting medical progress. However, even with innovative treatments, it’s important for all of us—scientists, physicians, and patients alike—to base our choices on sound science and accurate information. One of the main hopes for dealing with these situations, at least in the US, is that the FDA will take more proactive action and re-examine the way that these types of treatments are assessed and regulated, perhaps as a result of their forthcoming meeting (FDA, 2016). Most of us don’t hold a ton of sway with the FDA and, while we can make points and arguments, the likeli-
hood that we as individuals will be able to influence their processes may not be particularly high. However, Alta highlighted another route that is considerably more accessible. One of the major issues with unproven treatments is direct-to-consumer advertising, circumventing the usual medical channels and going straight to the patients. These advertisements are out in public, and we can all see them. I’ve certainly noticed them while flipping through in-flight magazines on planes, and I have had a personal experience of a relative highlighting one that appeared in a local newspaper and asking me if I thought it was a good idea to pursue. This is a place where we as consumers and scientists could have a more direct effect. In the US, the FTC has very clear rules about truth in advertising (FTC, 2016), and they will pursue and even litigate in situations where they find that advertising is clearly false or misleading. They are very clear that advertisers need to have data to support claims that they make. But, the FTC needs to know that a problem exists in order to do anything about it, and Alta argued strongly that they take particular notice of the volume of complaints! So, that’s where the community could come in—if we see something we think is misleading, we have the power, and one might even argue the responsibility, to say something about it, and if enough of us do we could even bring about meaningful change. The FTC has online information about how to contact them, and they encourage use of their ‘‘complaint assist’’ site (see Web Resources section for links). I tried it out for an advertisement I saw recently that I felt made misleading medical claims, and it was quite straightforward and easy to use. The online form is designed to be multi-functional and some of the questions are clearly aimed at people who have actually experienced a misrepresented service as opposed to just seeing an advertisement about it. Testimonials from patients who are directly affected would be particularly effective, so if you do come across people who are in that situation it is a good idea to encourage them to take action themselves. But, there’s no need to have information to put in all of those boxes to register a concern about presentation of unsupported claims. If you’re as inspired by this idea as I am, there’s more you can do as well. I’m sure you are well aware of legislative efforts in the US to look at regulation of stem cell treatment options, including particularly the REGROW Act, which could encourage further expansion of clinics offering unproven treatments. If you have comments or concerns, you have the option of expressing those to elected representatives or committee members through various different routes, and again we in the scientific and medical communities can add weight to these discussions through our background expertise and through sheer force of numbers. The title of this piece comes from a US Department of Homeland Security campaign, but I thought it seemed very fitting—a call to all of us to use the mechanisms we have available to us to make our voices heard. Most of what I have covered focuses on US-based activities, but similar advertising standards organizations and legislative processes exist in many other countries, so there’s no reason why this couldn’t be a global effort. The UK, for example, has an Advertising Standards Authority and Cell Stem Cell 19, August 4, 2016 ª 2016 Elsevier Inc. 139
Cell Stem Cell
Editorial Australia has an Advertising Standards Bureau, and both clearly accept consumer complaints. And, as is the case for many global action initiatives, the first stage begins with us as individuals stepping up and doing something ourselves.
WEB RESOURCES
The URLs for data presented herein are as follows: Advertising Standards Authority, https://www.asa.org.uk/ Advertising Standards Bureau, https://adstandards.com.au/ Arnold, A. (2016). The life and death of Sheila Drysdale. ABC AU. http:// www.abc.net.au/radionational/programs/backgroundbriefing/the-lifeand-death-of-sheila-drysdale/7641124 FDA (2016). Draft Agenda: Part 15 Hearing: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products, http://www.fda.gov/biologicsbloodvaccines/newsevents/ workshopsmeetingsconferences/ucm509279.htm
140 Cell Stem Cell 19, August 4, 2016
FTC (2016). Truth in Advertising, https://www.ftc.gov/news-events/ media-resources/truth-advertising FTC Complaint Assist, https://www.ftccomplaintassistant.gov/ Information#crnt&panel1-1 FTC Contact, https://www.ftc.gov/contact ISCT (2015). ISCT Presidential Task Force on the Use of Unproven Celluar Therapies: Reference Guide, http://www.celltherapysociety.org/? page=PTF2015 ISSCR (2015). A Closer Look at Stem Cells, http://www. closerlookatstemcells.org/ ISSCR (2016b). Guidelines for Stem Cell Research and Clinical Translation, http://www.isscr.org/home/publications/2016-guidelines Kolata, G. (2016). A Cautionary Tale of Stem Cell Tourism. The New York Times. http://www.nytimes.com/2016/06/23/health/a-cautionarytale-of-stem-cell-tourism.html?_r=1
Deborah J. Sweet
Editor, Cell Stem Cell http://dx.doi.org/10.1016/j.stem.2016.07.014
Editorial ‘‘If You See Something, Say Something’’ The ISSCR Annual Meeting in June was packed to the gills with interesting talks. Many of these were about science, and they were a great way to get updated about how leaders in the field are thinking about a broad range of issues. But ISSCR 2016 gave us more than that as well: a call to action. During the Saturday morning session, the prominent University of Wisconsin ethicist Alta Charo spoke about translational applications of genome editing and the lessons we can learn from ‘‘stem cell tourism.’’ Alta outlined her perspective that the scientific community has to a significant extent missed the boat on speaking up about and trying to counteract misleading claims by stem cell clinics that have led patients to, at best, spend money on treatments that have unknown effects and, at worst, do something that causes them actual harm. The recent example of Jim Gass, as reported in the New York Times (Kolata, 2016), who has a mass in his spine caused by stem cell transplantation he received outside the US, was fresh in our minds. Since the meeting, we’ve also heard about Sheila Drysdale, who passed away after a stem cell treatment in Australia (Arnold, 2016). And, as is evident from the articles we have in this issue from Turner and Knoepfler, focusing on the US, and from Rasko et al., with a more global perspective, this is not just a problem that happens ‘‘somewhere else.’’ It’s an issue even in countries with strong regulatory systems that pride themselves on providing high-quality medical care. Alta’s focus for her talk was on using the lessons from past experience to prompt more proactive action as genome editing starts to become a new ‘‘magic word,’’ but I would also argue that there’s still time and space for us to apply her suggestions to the stem cell arena as well. Of course this is not a new topic. Many in the scientific and medical communities have been highlighting it for some time, through presentations at meetings, journal articles, and interviews with the mainstream media, but that evidently hasn’t been enough to stem the tide. The ISSCR has also taken a proactive stance by putting together their ‘‘A Closer Look at Stem Cells’’ website (ISSCR, 2015), an online resource to help patients navigate the overall landscape and make informed decisions about which healthcare options they choose. They have also provided a comprehensive set of guidelines about responsible clinical translation covering the conduct of research and clinical trials and encouraging the community to speak up when something seems amiss (ISSCR, 2016). Another scientific organization, the ISCT, has issued its own set of guidelines about unproven treatments as well (ISCT, 2015). We do need to be mindful of the important balance that society has to strike between providing appropriate safeguards and supporting medical progress. However, even with innovative treatments, it’s important for all of us—scientists, physicians, and patients alike—to base our choices on sound science and accurate information. One of the main hopes for dealing with these situations, at least in the US, is that the FDA will take more proactive action and re-examine the way that these types of treatments are assessed and regulated, perhaps as a result of their forthcoming meeting (FDA, 2016). Most of us don’t hold a ton of sway with the FDA and, while we can make points and arguments, the likeli-
hood that we as individuals will be able to influence their processes may not be particularly high. However, Alta highlighted another route that is considerably more accessible. One of the major issues with unproven treatments is direct-to-consumer advertising, circumventing the usual medical channels and going straight to the patients. These advertisements are out in public, and we can all see them. I’ve certainly noticed them while flipping through in-flight magazines on planes, and I have had a personal experience of a relative highlighting one that appeared in a local newspaper and asking me if I thought it was a good idea to pursue. This is a place where we as consumers and scientists could have a more direct effect. In the US, the FTC has very clear rules about truth in advertising (FTC, 2016), and they will pursue and even litigate in situations where they find that advertising is clearly false or misleading. They are very clear that advertisers need to have data to support claims that they make. But, the FTC needs to know that a problem exists in order to do anything about it, and Alta argued strongly that they take particular notice of the volume of complaints! So, that’s where the community could come in—if we see something we think is misleading, we have the power, and one might even argue the responsibility, to say something about it, and if enough of us do we could even bring about meaningful change. The FTC has online information about how to contact them, and they encourage use of their ‘‘complaint assist’’ site (see Web Resources section for links). I tried it out for an advertisement I saw recently that I felt made misleading medical claims, and it was quite straightforward and easy to use. The online form is designed to be multi-functional and some of the questions are clearly aimed at people who have actually experienced a misrepresented service as opposed to just seeing an advertisement about it. Testimonials from patients who are directly affected would be particularly effective, so if you do come across people who are in that situation it is a good idea to encourage them to take action themselves. But, there’s no need to have information to put in all of those boxes to register a concern about presentation of unsupported claims. If you’re as inspired by this idea as I am, there’s more you can do as well. I’m sure you are well aware of legislative efforts in the US to look at regulation of stem cell treatment options, including particularly the REGROW Act, which could encourage further expansion of clinics offering unproven treatments. If you have comments or concerns, you have the option of expressing those to elected representatives or committee members through various different routes, and again we in the scientific and medical communities can add weight to these discussions through our background expertise and through sheer force of numbers. The title of this piece comes from a US Department of Homeland Security campaign, but I thought it seemed very fitting—a call to all of us to use the mechanisms we have available to us to make our voices heard. Most of what I have covered focuses on US-based activities, but similar advertising standards organizations and legislative processes exist in many other countries, so there’s no reason why this couldn’t be a global effort. The UK, for example, has an Advertising Standards Authority and Cell Stem Cell 19, August 4, 2016 ª 2016 Elsevier Inc. 139
Cell Stem Cell
Editorial Australia has an Advertising Standards Bureau, and both clearly accept consumer complaints. And, as is the case for many global action initiatives, the first stage begins with us as individuals stepping up and doing something ourselves.
WEB RESOURCES
The URLs for data presented herein are as follows: Advertising Standards Authority, https://www.asa.org.uk/ Advertising Standards Bureau, https://adstandards.com.au/ Arnold, A. (2016). The life and death of Sheila Drysdale. ABC AU. http:// www.abc.net.au/radionational/programs/backgroundbriefing/the-lifeand-death-of-sheila-drysdale/7641124 FDA (2016). Draft Agenda: Part 15 Hearing: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products, http://www.fda.gov/biologicsbloodvaccines/newsevents/ workshopsmeetingsconferences/ucm509279.htm
140 Cell Stem Cell 19, August 4, 2016
FTC (2016). Truth in Advertising, https://www.ftc.gov/news-events/ media-resources/truth-advertising FTC Complaint Assist, https://www.ftccomplaintassistant.gov/ Information#crnt&panel1-1 FTC Contact, https://www.ftc.gov/contact ISCT (2015). ISCT Presidential Task Force on the Use of Unproven Celluar Therapies: Reference Guide, http://www.celltherapysociety.org/? page=PTF2015 ISSCR (2015). A Closer Look at Stem Cells, http://www. closerlookatstemcells.org/ ISSCR (2016b). Guidelines for Stem Cell Research and Clinical Translation, http://www.isscr.org/home/publications/2016-guidelines Kolata, G. (2016). A Cautionary Tale of Stem Cell Tourism. The New York Times. http://www.nytimes.com/2016/06/23/health/a-cautionarytale-of-stem-cell-tourism.html?_r=1
Deborah J. Sweet
Editor, Cell Stem Cell http://dx.doi.org/10.1016/j.stem.2016.07.014