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Download the Print Version of Inside Stanford Medical students found out March 17 where they would be STANFORD going for their residencies. Page 4 INSIDE Volume 9, No. MEDICINE6 March 27, 2017 Published by the Office of Communication & Public Affairs Stem cell ‘therapy’ blinds three patients By Becky Bach The three patients — all women, ranging in age cells injected intravitreal in dry macular degeneration.” from 72 to 88 — suffered from macular degeneration, a Some of the patients believed they were participating hree people with macular degeneration were common, progressive disease of the retina that leads to in a trial, although the consent form and other written blinded after undergoing an unproven stem cell loss of vision. Before the surgery, the vision in their eyes materials given to the patients did not mention a trial, Ttreatment that was touted as a clinical trial in ranged from 20/30 to 20/200. Now, the patients are Albini said. 2015 at a clinic in Florida. Within a week following the likely to remain blind, said co-author Thomas Albini, “There’s a lot of hope for stem cells, and these types treatment, the patients experienced a variety of com- MD, an associate professor of clinical ophthalmology at of clinics appeal to patients desperate for care who hope plications, including vision loss, detached retinas and the University of Miami, where two of the patients were that stem cells are going to be the answer, but in this hemorrhage. They are now blind. subsequently treated for complications from the stem case these women participated in a clinical enterprise A paper documenting the cases was published March cell treatments. “Although I can’t say it’s impossible, it’s that was off-the-charts dangerous,” Albini said. 16 in The New England Journal of Medicine. extremely unlikely they would regain vision.” Each patient paid $5,000 for the procedure. Any The article is a “call to awareness for patients, physi- Appealing to patients ‘desperate for care’ clinical trial that has a fee should raise a red flag, the cians and regulatory agencies of the risks of this kind of authors said. minimally regulated, patient-funded research,” said Jef- Two of the patients learned of the so-called clinical “I’m not aware of any legitimate research, at least in frey Goldberg, MD, PhD, professor and chair of oph- trial on ClinicalTrials.gov, a registry and results database ophthalmology, that is patient-funded,” Albini said. thalmology at the School of Medicine and co-author of run by the U.S. National Library of Medicine, where At the clinic, which is not named in the paper, the the paper. it was called “Study to assess the safety and effects of patients had fat cells removed from their abdomens NORBERT VON DER GROEBEN and a standard blood draw. The fat tissue was processed with enzymes, with the goal of obtaining stem cells. Platelet-dense plasma was isolated from the blood. The cells were then mixed with the platelet-dense plasma and injected into their eyes. Patients reported that the entire process took less than an hour, Albini said. The patients had both eyes treated at once — another red flag, Albini and Goldberg said, because most doctors would opt for a conservative approach to observe how one eye responds to an experimental treatment before attempting the other eye. Shoddy stem cell preparation may have led to some of the patients’ complications, which could have been caused by injection of a contaminant or the cell wash solution into the eye, Albini said. When injected into the eye, the stem cells also could have changed into myofibroblasts, a type of cell associated with scarring. No evidence of vision restoration But even if executed correctly, there is no evidence suggesting that the procedure could help restore vision, Goldberg and Albini said. In fact, there is sparse evi- dence that adipose-derived stem cells, the type of cells that the clinic claimed to use, are capable of differenti- ating, or maturing, into retinal pigment epithelium or photoreceptor cells, which play a critical role in macular Jeffrey Goldberg and his colleagues examined the cases of three women who were blinded after undergoing an unproven stem cell treatment. degeneration and are the See BLINDED, page 6 Initial hospital costs for gunshot Psychiatrist advised producers wounds just ‘tip of the iceberg’ on upcoming teen-suicide drama By Erin Digitale tion efforts for By Devika G. Bansal shot wounds: It does not include costs of Palo Alto teen- emergency room visits — medical costs When Stanford psychiatrist Rona Hu, agers, so she was Gun violence resulted in initial hospi- for patients who are treated and released MD, was invited to help shape the script already accus- talization costs of more than $6.6 billion or those who are treated but die before of a Netflix series about teenage suicide, tomed to discuss- nationwide from 2006 through 2014 — admission — or hospital readmissions. she knew it would be an unusually good ing the subject. an average of $734.6 million per year, ac- The study was published online opportunity to communicate with teen- In the novel, cording to a study by researchers at the March 21 in the American Journal of agers about mental health issues. Th1rt3en Reasons School of Medicine. Public Health. The lead author is medi- The new series, 13 Reasons Why, Why, the book’s VAL LAWLESS / SHUTTERSTOCK.COM cal student Sarabeth Spitzer. The senior which premieres March 31, is based on main character, Rona Hu author is Thomas Weiser, MD, associate a bestselling 2007 novel about a high- Hannah, records professor of surgery. school student who dies by suicide after cassette tapes that “There is a high cost for these injuries, being bullied by her classmates. she arranges to have sent to people who especially because they are preventable,” The show’s producers faced a chal- bullied her. Two weeks after her death, Spitzer said. The study included hospi- lenge: They wanted to retain the book’s they receive the tapes, on which Hannah talization costs of shooting injuries that basic plot without romanticizing suicide, explains how each of them contributed were self-inflicted, unintentional or due since such portrayals can contribute to to her desire to die. to assault. suicide contagion. Hu agreed to advise ‘Concerned by a number of things’ Little research on gun violence them. “It was a good opportunity to make “I was concerned by a number of At Stanford, 10 percent of trauma pa- sure that something about suicide was things,” Hu said, describing her reactions In an analysis of data from 267,265 tients are admitted with gunshot or knife handled responsibly in the media,” said to the novel. “There are only teenagers in patients who were admitted for firearm- wounds — a small but important pro- Hu, clinical associate professor of psychi- the book; parents are barely mentioned. related injuries during the nine-year pe- portion of the patient population, Weiser atry and behavioral sciences. “The pro- If teens are contemplating suicide to riod, the researchers reported that the said. duction team seemed very sincere about get back at bullies, they may not realize $6.6 billion figure is only a fraction of Despite the scale of the problem, there wanting to do good and not do harm.” how much collateral damage they can the total hospital costs incurred by gun- exists surprisingly See GUN, page 6 Hu has volunteered in suicide-preven- do to people See DRAMA, page 7 Studies of scientific bias targeting the right problems By Jennie Dusheck The team also found that small and highly cited studies because interventions might need to be tailored to the In all fields of science, small studies, early studies and those in peer-reviewed journals seemed more likely needs and problems of individual disciplines of fields. and highly cited studies consistently overestimate ef- to overestimate effects; U.S. studies and early studies One-size-fits all solutions are unlikely to work.” fect size, according to a study led by researchers at the seemed to report more-extreme effects; early-career Solutions and interventions School of Medicine. researchers and researchers working in small or long- A scientist’s early career status, isolation from other distance collaborations were more likely to overestimate Ioannidis likewise cautioned that the data are purely researchers and involvement in misconduct also ap- effect sizes; and, not surprisingly, researchers with a his- observational, not experimental, and the question of pear to be risk factors for unreliable results, the research tory of misconduct tended to overestimate effect sizes. how to reduce bias is far from clear. For example, he team reported. On the other hand, studies by highly cited authors said, just because small studies tend to give exaggerated A paper describing the work was published online who published frequently were not more affected by results doesn’t mean we should stop doing them. “One March 20 in the Proceedings of the National Academy bias than average. Research by men was no more likely might say immediately, well, we need to do large stud- of Sciences. The lead author is Stanford senior research to show bias than that of women. And scientists in ies,” he said. “That would be an intervention. But you scientist Daniele Fanelli, PhD, and the senior author is countries with very strong incentives to publish, such as can’t necessarily translate an association directly into an John Ioannidis MD, DSc, professor of medicine and of the United States, didn’t seem to have effective intervention.” NORBERT VON DER GROEBEN health research and policy. more bias than studies from countries “I think that one can take Virtually all scientific work may be afflicted by some where the pressure was less.
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