Treatment offers ray of hope<\/p>\n
One day recently, Jordan Blevins\u2019 sister, Sarah, caught him doing a newspaper crossword puzzle.<\/p>\n
\u201cI was just amazed,\u201d said Sarah, 19, who doesn\u2019t get to see her brother much between work and school \u2013 she\u2019s a sophomore at Indiana University-Purdue University Fort Wayne. Still, in the limited time they spend together, she\u2019s noticed marked changes in his spelling and sociability: \u201cHe\u2019ll take to people (where) he used to kind of hide and shy away.\u201d<\/p>\n
Jordan, 16, had been on the lower functioning end for children with Down syndrome, but now he\u2019s approaching the other end of the spectrum, says his mother, Linda Blevins. She owes that to an experimental protocol developed by a Houston-based woman and parent of a child with Down syndrome.<\/p>\n
The protocol Jordan is on is in its infancy. But early signs are encouraging, and some parents aren\u2019t waiting for a formal clinical trial to take action.<\/p>\n
Still, there\u2019s much pushback. Major Down syndrome advocacy groups and some doctors and scientists have signed an advisory letter warning that the treatments are untested and potentially harmful. Enthusiastic parents, who have children on the protocol, and some professionals, who have worked with those kids, also advocate more study. But they see the outspoken opposition as baffling and unfounded and an obstacle to what some consider the biggest breakthrough in Down syndrome therapies in decades.<\/p>\n
Jordan\u2019s change<\/span><\/p>\n Used to be, Linda Blevins said, \u201cWe couldn\u2019t get (Jordan) out of the basement.\u201d Now when he goes out, Jordan is the most animated in the group.<\/p>\n His eye-crossing has decreased dramatically. His reaction time, articulation and vocabulary have improved. Homework sessions, once a two-hour struggle, now last 20 to 45 minutes, Blevins said, because he\u2019s less distracted.<\/p>\n \u201cI just know that the kid is better, and I\u2019m so grateful that he\u2019s better,\u201d Blevins said.<\/p>\n It\u2019s not that he\u2019s cured; on a basic genetic level his condition is coded into his makeup. Down syndrome occurs when a person has three copies \u2013 instead of two \u2013 of the 21st chromosome. It affects more than 400,000 people in the U.S., altering development, causing cognitive delays, raising the risk of congenital heart defects, Alzheimer\u2019s disease and other medical conditions and decreasing life expectancy.<\/p>\n But the protocol \u2013 a combination of medications and supplements already on the market but not specifically indicated for treatment of people with Down syndrome \u2013 has improved his concentration and cognition, Blevins says. She\u2019s a parent adviser with the Changing Minds Foundation, formed to advance the protocol developed by Dr. Teresa Cody.<\/p>\n Cody, a dentist, leafed through volumes of research to design a daily herbal therapy that contains compounds shown in research at Stanford University to target the underlying cause of learning and memory problems.<\/p>\n At his home on a recent afternoon, Jordan downs some colorful capsules \u2013 medication for attention deficit hyperactivity disorder, fatty acids and an antioxidant combination not included in the protocol \u2013 reacting not unlike a child eating cooked spinach. He answers some questions, makes eye contact \u2013 something he didn\u2019t use to do \u2013 and talks excitedly about video games and bowling, before resisting his mother\u2019s attempts to make more small talk. Later, music \u2013 mostly rap \u2013 rises from the basement with low wailing, Jordan\u2019s attempt at a sing along. For Jordan, who also has autism, music and video games are part of his daily routine to unwind.<\/p>\n Jordan\u2019s mother says he meets the psychological criteria for prescribing Prozac. That\u2019s the portion of the protocol that draws the most concern from parents, in part because of Prozac\u2019s widely publicized link to suicidal thoughts and behaviors in teenagers. (A 2007 comprehensive analysis of antidepressants for children and teenagers says the benefits of treatment trump the small risk of increasing some patients\u2019 chances of having suicidal thoughts and behaviors.)<\/p>\n Linda Blevins says she\u2019s researched the risks and works closely with Jordan\u2019s doctors in implementing the protocol.<\/p>\n Although she\u2019s complimentary of Jordan\u2019s current physicians, Blevins and other parents say symptoms of ADHD \u2013 such as difficulty in focusing \u2013 often go unheeded. They say doctors, however, might treat those symptoms in patients without Down syndrome.<\/p>\n Others think it\u2019s unwise to use Cody\u2019s protocol without the backing of a large-scale clinical trial.<\/p>\n Waiting for proof<\/span><\/p>\n \u201cWe would not use this protocol with our daughter or recommend that others use it\u201d without an endorsement from the medical community, and that requires a clinical study, says Joe Bockerstette, a Fort Wayne resident and father of 10-year-old Amy who has Down syndrome.<\/p>\n Bockerstette is chairman of the National Down Syndrome Society, which instead endorsed \u2013 with about three dozen professionals and advocacy groups \u2013 an advisory statement cautioning parents and medical professionals against using Cody\u2019s protocol.<\/p>\n \u201cThere is no scientific evidence to support the use of any of this protocol with people with Down syndrome of any age in order to improve memory or any other aspect of cognition,\u201d a portion of the statement reads. \u201cNor is there any evidence that this protocol is safe for routine use with people who have Down syndrome.\u201d<\/p>\n This early indictment of the protocol has frustrated and infuriated parents who have seen profound changes in their children and say they\u2019ve been steadfast in their research and worked closely with their doctors in implementing the protocol. Cody, her son Neal and a handful of other children on the protocol and their parents were featured in a film, \u201cChanging a Mind,\u201d which premiered in September in New York City.<\/p>\n Those reached for this story substantiated the claims made in the film, saying their children connected more easily with others, communicated better, showed intellectual improvements in many subjects, were more diligent in their studies and had an easier time retaining information.<\/p>\n A Columbus, Ohio-based special education teacher who tutors kids with Down syndrome has recommended the protocol to families she\u2019s worked with and reported similar findings. Results varied, but side effects were typically non-existent or mild. Jordan, for instance, has trouble sleeping if he takes his ADHD medication too late in the day.<\/p>\n Cody estimated that hundreds of people with Down syndrome are on all, or part of, the protocol, including her son Neal, and there was at least one report of the protocol having initial success in adults. Neal\u2019s pediatrician, Dr. Louis Pottkotter, says it employs only time-tested elements with \u201cphenomenal\u201d results. Pottkotter says if he had a child with Down syndrome, he wouldn\u2019t wait a single day to put them on the protocol.<\/p>\n \u201cThese are things that we\u2019ve used for years really. It\u2019s not like it\u2019s anything radical or out of the ordinary,\u201d Pottkotter said. Although it hasn\u2019t previously been used to treat children with Down syndrome, he said, what Cody recommends is safe and proven effective in children.<\/p>\n Before Neal, now 11, was on the protocol, he was uncontrollable, Pottkotter said. Now he\u2019ll come into the office, talk with the doctor \u2013 his speech has improved dramatically \u2013 and calmly read a book. And he hasn\u2019t suffered any side effects. The blank behind his eyes from two years ago has been replaced by recognition. He\u2019s aware of his surroundings in a way he never was before, Pottkotter says.<\/p>\n Despite such results, Cody is used to her protocol being met with skepticism.<\/p>\n \u201cI\u2019m not saying this is a magic pill,\u201d Cody said. \u201cWhat I\u2019m saying is, \u2026 each kid has improved compared to themselves.\u201d<\/p>\n Bockerstette doesn\u2019t dispute the claims made by parents whose kids are on the protocol, but he says there have been a fair amount of alternative treatments over the years that didn\u2019t pan out for people with Down syndrome.<\/p>\n There is an Alzheimer\u2019s drug called Aricept that, when taken by people with Down syndrome in small-scale clinical trials, appeared to improve language skills. But according to publicly released results of the trials, it didn\u2019t affect cognitive capacities, said a physician board member of National Down Syndrome Society.<\/p>\n There is no medication to improve cognition in people with Down syndrome, said Dr. Brian Skotko, a pediatrician with Children\u2019s Hospital Boston. He acknowledged that drugs like Prozac have been on the market for years but said they haven\u2019t been tested for use in people with Down syndrome.<\/p>\n Bockerstette says he and his family take a conservative approach. He\u2019d consider drug therapy, but \u201cit would have to be something pretty spectacular.\u201d<\/p>\n Winning conservative adherents requires publicized research. And research for Down syndrome therapies is something most everyone \u2013 Bockerstette included \u2013 says is underfunded.<\/p>\n In the meantime, Skotko says it\u2019s up to parents, working with their doctors, to decide what\u2019s best for their children. But without more evidence he doesn\u2019t think many doctors will back the protocol.<\/p>\n No time to waste<\/span><\/p>\n So Craig Garner is busy trying to raise money.<\/p>\n Garner is a professor of psychology and behavioral science and the coordinator of the Down Syndrome Research Center at Stanford University. His research of mice modeling Down syndrome \u2013 with extra copies of the mouse equivalent to human chromosome 21 genes \u2013 is central to Cody\u2019s protocol. It showed that the inhibitory brain cells signal too strongly, impairing the brain\u2019s ability to retain what is learned.<\/p>\n \u201cDown syndrome is just like riding the brake all the time; you just can\u2019t encode new information,\u201d Garner said. His team discovered a drug therapy for Down syndrome that addresses the issue, essentially removing the brake.<\/p>\n He said he hopes to begin testing Cody\u2019s protocol as early as next spring but getting the necessary funding is a major obstacle.<\/p>\n The centerpiece of that protocol, Ginkgo biloba, is a plant extract made up of many compounds. The trick will be isolating and then developing a pure compound that can be tested and replace it. (Critics say since it\u2019s not entirely known how the plant extract works it shouldn\u2019t be used for treatment. Proponents say it\u2019s taken in small doses, adding that it\u2019s been used for thousands of years.) Cody has said that her protocol is just the first step \u2013 albeit a big one \u2013 and she\u2019s open to drugs that might replace individual components.<\/p>\n Garner estimates it would probably cost $1 million to appropriately test the protocol Cody developed. Initial testing of just one compound that could supplant Ginkgo biloba could reach $4 million to $5 million.<\/p>\n But if the treatment does get its day in the sun, it could prove the biggest conceptual shift in Down syndrome therapy since children were pulled from institutions in the 1960s, Garner said.<\/p>\n