Life Science Leader Magazine

NOV 2013

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Exclusive Life Science Feature stem cell research, but helping thought leaders of science and theology gain an understanding of one another. One of the best mechanisms by which to do this is through a conference with "open dialogue." It took about a year and a half to put together the first conference, held at the Vatican, Nov. 9-11, 2011, and titled, "Adult Stem Cells: Science and the Future of Man and Culture." It included adult stem cell research experts, recognized leaders in life sciences, medicine, religion, ethics, public policy, as well as CBS award-winning medical broadcast journalist, Max Gomez, Ph.D. "We felt that if we could get a statement from the pope during the event saying he supports adult stem cell therapies, people would truly believe the Catholic Church was supportive of this science, which would be monumental," says Smith in regard to gaining buy-in from the masses. "We told the pope we intended to write a book as another component of the educational process." Entitled, The Healing Cell: How the Greatest Revolution in Medicine Is Changing Your Life, the book is co-authored by Smith, with Monsignor Tomasz Trafny and Max Gomez. It also includes a foreword by Gianfranco Cardinal Ravasi, president of the Pontifical Council for Culture, and an address by Pope Benedict XVI, which states, "In general, no such ethical problems arise when stem cells are taken from the tissues of an adult organism, from the blood of the umbilical cord at the moment of birth, or from fetuses who have died of natural causes." This type of statement from the pope is exactly what the collaboration team hoped would move their educational initiative forward. The book, published April 2, 2013, was followed by the second international educational conference at the Vatican. Building upon the success of the previous conference, this year's tripled in the number of attendees and included correspondents from the Wall Street Journal, CBS, NBC, and Fox, actual stem cell patients, top-level researchers from the likes of the Dana-Farber Cancer Institute and the University of Texas MD Anderson Cancer Center, as well as numerous industry executives from such well-known companies as Pfizer and Celgene. "We also brought students in from around the world via a student ambassador program, to create a bigger education platform," states Smith. "Not only do we have to educate church leaders and individuals, but you have the whole secondary process to help the next generation of thought leaders understand the science, misconceptions, and the various issues surrounding stem cell research." According to Smith, the collaboration has set its sights on milestones around electronic media, e-learning, DVDs, and social media. The collaboration also would like to raise money to help fund stem cell research. "Until investors see there is a pathway to commercialization and a clear regulatory pathway to approval, funding will not be plentiful," she affirms. "In the meantime, we need to look for support through foundations, grants, and philanthropic money and create a forum for funding these programs." Smith believes the collaboration a success, pointing to the fact that even with the changing of the pope from Benedict XVI to Pope Francis, the partnership was extended through 2020. NeoStem's CEO has had a busy year, co-authoring and publishing a book, moving the company from trading on the NYSE to the NASDAQ, brokering an agreement with the Vatican, hiring a new CFO, CMO, and executive vice president, and receiving a Key Founder's Award from the Vatican. Investors have been taking notice of Smith's efforts. With the stock trading around its 52-week high of just under $10 (at the time of this writing), some analysts are anticipating an even greater upside, especially if the company gets good news on AMR-001, a treatment targeting patients at risk from congestive heart failure, significant arrhythmias, premature death, and acute coronary syndrome — a $1.2 billion market. IS MIXING RELIGION AND SCIENCE A GOOD IDEA? According to the University of Maryland Medical Center, a growing number of studies reveal that spirituality may play a bigger role in the healing process than previously thought. Qualities like faith, hope, forgiveness, and the use of social support and prayer seem to have a noticeable effect on health and healing. For example, a 35-year clinical study of Harvard graduates revealed that graduates who expressed hope and optimism lived longer and had fewer illnesses in their lifetime. Results from several studies indicate that people with strong religious and spiritual beliefs heal faster from surgery, are less anxious and depressed, have lower blood pressure, and cope better with chronic illnesses. "When people have a health illness, they either go to religion or reject it," says Robin Smith, M.D., the chairman and CEO of NeoStem. Some may argue that spirituality or prayer in treatment is merely a placebo effect. They may be right. In the January-February 2013 issue of Harvard Magazine, Ted Kaptchuk, a professor of medicine at Harvard Medical School and the director of the Harvard-wide Program in Placebo Studies and the Therapeutic Encounter (PiPS), reported a very interesting finding just two weeks into a randomized clinical drug trial. Nearly a third of the 270 subjects complained of awful side effects. All of the subjects had enrolled in the study hoping to alleviate severe arm pain. In one part of the study, half of the subjects received pain-reducing pills; the others were offered 40 LifeScienceLeader.com November 2013 acupuncture to alleviate the pain. In both cases, people began calling in complaining of side effects, which just so happened to be the same as the side effects they had been warned the treatment would produce. More astoundingly, other patients reported real relief, and those who received acupuncture felt better than those on the anti-pain pill. No study had ever proven acupuncture to be superior to painkillers — neither did Kaptchuk's. Here's why. The pills were placebos consisting of cornstarch. The acupuncture needles were retractable shams that never pierced the skin. The study was designed to compare two fakes. Researchers have found that placebo treatments can stimulate real physiological responses, and thus why one of the key components to gaining drug approval is proven superiority of an active medication over placebo. According to Kaptchuk, the challenge now is to uncover the mechanisms behind these physiological responses – what is happening in our bodies, brains, in the method of delivery (e.g. needle versus pill), in the room where placebo treatments are administered (e.g. calming physical surroundings, caring versus curt doctor) — because the effect is actually many effects woven together. While at it, perhaps researchers should investigate spirituality's impact on the placebo effect. Rather than trying to separate science and religion, let's take a closer look as to how they may, or may not be, inextricably intertwined.

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