Fwd: American Children's Health in Acute Crisis

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ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIAmerican children's health is in a state of acute crisis--and children arethe fastest growing market for the pharmaceutical industry.Indeed, "an unparalleled rise in adolescent girls (aged 10--19) usingprescription drugs to treat diabetes, sleep problems, and psychologicaldisorders."http://ahrp.blogspot.com/2007/07/medco-report-girls-at-risk.htmlThe New York Times reports (below) that 30% of American children areoverweight--in some regions 45% are obese. According to data tracked byMedco Health Solutions, Express Scripts and Verispan, reveals that a growingnumber of American children--more than 600,000--are taking drugs for a widerange of chronic conditions related to childhood obesity. An alarming increase in pediatric prescriptions--between 2001-2007: Type 2 diabetes drugs prescribed off-label for children, jumped 151%;heartburn (acid reflux) prescriptions jumped 136.5%; high blood pressuredrugs increased 18.4%; and, high cholesterol increased 11.6%. All thesedrugs are prescribed for "problems linked to obesity that were practicallyunheard-of in children two decades ago."The Times quotes several concerned physicians: "We were amazed at howquickly the rates of drugs used have climbed," said Dr. Donna Halloran ofSt. Louis University.  And a recognition that the problem is systemic: "Someexperts have expressed concern that the increases in many of theseobesity-related drugs reflect a systemic failure, with doctors and parentsturning to them because they find life-style changes too difficult toimplement or enforce."Dr. David Collier, director of a pediatric weight management center inGreenville, N.C. is among doctors who support the controversialrecommendation by the American Academy of Pediatrics to use statins to lowerchildren's cholesterol. One of his patients prescribed statins is a 6 yearold girl.Dr. Francine Kaufman, a pediatric endocrinologist, recalls a 13-year oldteen age girl whose weight increased to 267 pounds. Dr. Kaufman prescribed 5drugs.An astronomical increase in U.S. pediatric prescriptions for powerfulpsychotropic drugs never before prescribed for children was also documentedby Medco.The company's chief medical officer, Dr. Robert Epstein, expressed concern:"While drug therapy is essential for certain patients, the risks andbenefits must always be weighed and, when clinically appropriate, non-drugtreatments should be the initial approach."Unfortunately, American medical practice is no longer governed by evidenceand the precautionary principle. Instead, American medicine is governed byindustry influence and profits, for corporations and (so-called)non-profits. Thus lack of efficacy and evidence of harm are disregarded: "Even in clinical trials where adult pills were crushed and such, you oftencan't even demonstrate that the medication works," said Dr. StephenSpielberg, former dean of Dartmouth Medical School.Surely, history will not deal kindly with a society that sacrifices itschildren's health for corporate wealth. Contact: Vera Hassner Sharavveracare212-595-8974http://www.nytimes.com/2008/07/26/business/26kidmed.html?_r=1 & scp=1 & sq=wight%20pills%20stephanie%20saul & st=cse & oref=sloginTHE NEW YORK TIMESJuly 26, 2008Weight Drives the Young to Adult Pills, Data SaysBy STEPHANIE SAULA growing number of American children are taking drugs for a wide range ofchronic conditions related to childhood obesity, according to prescriptiondata from three large organizations.The numbers, from pharmacy plans Medco Health Solutions, Express Scripts andthe marketing data collection company Verispan, indicate that hundreds ofthousands of children are taking medication to treat Type 2 diabetes, highblood pressure, high cholesterol and acid reflux - all problems linked toobesity that were practically unheard-of in children two decades ago.The data, disclosed publicly in recent months or provided at the request ofThe New York Times, shows that concerns that children will be taking adultmedications - heightened recently by a controversial recommendation by anational pediatricians group - are already a reality.This month, the American Academy of Pediatrics said that more children, asyoung as 8, should be given cholesterol-lowering drugs. The recommendationwas quickly attacked by some experts as a license to put children ongrown-up drugs.While the drugs do help treat the conditions, some doctors fear they aresimply a shortcut fix for a problem better addressed by exercise and diet.Even so, some pharmaceutical companies are developing new versions,including flavored ones, of adult medications for children.While some of the percentage increases in the three analyses aresignificant, doctors empha-size that prescriptions of these drugs tochildren still represent less than 1 percent of their sales.Express Scripts and Medco developed estimates of how many children might betaking such drugs by extrapolating their data - involving a total of morethan four million children - across the broader population.The companies use different assumptions to reach their estimates, but thedata suggests that at least several hundred thousand children are on variousobesity-related medications.The greatest increase occurred in drugs for Type 2 diabetes, with Medco'sdata showing a 151 percent jump from 2001 to 2007.Medco's data, released in May, showed that use of drugs to treat acid refluxproblems in children, often aggravated by obesity, increased 137 percentover seven years. Its analysis also showed an 18 percent increase in drugsto treat high blood pressure and a 12 percent increase incholesterol-lowering medications during the seven-year period.Express Scripts found a 15 percent increase over three years in drugs totreat cholesterol and other fats in the blood, a category that is primarilystatins."We were amazed at how quickly the rates of drugs used have climbed," saidDr. Donna R. Halloran, an assistant professor at St. Louis University whoworked on the Express Scripts analysis, presented at a meeting of theAmerican Public Health Association in November.Verispan data recorded a 13 percent increase in high blood pressureprescriptions in the under 19 age group from 2005 to 2007. Its numbers show,however, a less than 1 percent increase during the period incholesterol-lowering drugs in children.Doctors and some financial analysts have said that less pronounced increasesin cholesterol drugs compared with some other medications - seen in allthree analyses - reflect a wariness by some doctors about using those drugsin children.Some experts have expressed concern that the increases in many of theseobesity-related drugs reflect a systemic failure, with doctors and parentsturning to them because they find lifestyle changes too difficult toimplement or enforce."I think a lot of people in pediatrics, myself included, are struggling withwhat is the right management to do for these kids," said Dr. Russell L.Rothman, an assistant professor at Vanderbilt University, who recentlysurveyed doctors and found wide variations in how children were beingtreated."You see elevated blood pressure, or elevated sugars, or elevatedcholesterol and you try exercise and diet and you don't see anyimprovement," Dr. Rothman said. "I worry that some providers and somefamilies are looking for the quick fix, and are going to want to startmedication immediately." Some pediatricians say they have been treatingchildren with statins for several years.Dr. David Collier, director of a pediatric weight management center at EastCarolina University in Greenville, N.C., an area where 45 percent of thechildren are overweight, is among doctors who support the recentrecommendations that statins may be warranted in some children as young as8. "We have been using statins for two or three years now," he said.One of his statin patients, he said, was a 6-year-old girl.Dr. Collier, who describes his location as "right smack dab in the middle ofthe stroke belt," believes that aggressive therapy is needed to prevent ahealth crisis. "It's hard to overstate the size of the problem," he said.Dr. Francine R. Kaufman remembers a patient, a 13-year-old girl, whoseweight had ballooned to 267 pounds. The teenager appeared destined for thesame fate as her grandmother, who lost a leg to Type 2 diabetes."To control her high blood sugar level, her high blood pressure, and herhigh cholesterol, this young girl left my office with five medications," Dr.Kaufman, a pediatric endocrinologist in Los Angeles, told a Senatesubcommittee last week during hearings on obesity in children.The girl stood out as unusual more than 10 years ago, but children with thesame array of problems are increasingly seen in the diabetes center whereshe practices at Children's Hospital Los Angeles, Dr. Kaufman said.Diet and exercise are tried first, but "lifestyle is really tough," Dr.Kaufman said. Some of her patients live in neighborhoods without grocerystores and attend schools that do not offer physical education programs."They deserve to be treated," Dr. Kaufman said. "I think the slant from mostof the media is that pediatricians are jumping to put kids on medications.That's not true at all. Since lifestyle is so difficult, we have no otherchoice but to go to pharmacotherapy."At Camp Pocono Trails, a weight loss camp in Reeders, Pa., that enrollsabout 700 children each summer, owner Tony Sparber said that campers arearriving with medications, a pharmacopeia that include statins and diabetesmedications."You just look at these kids' medical forms," Mr. Sparber said. "You seekids with some very high-risk numbers. Cholesterol in the high 200s."Experts say that the trend could balloon health care costs. As many as 30percent of children nationwide are overweight. And children who start suchmedication often rely on the drugs for a lifetime and are prone to healthproblems as adults.Despite a push by the Food and Drug Administration to foster drug studies inchildren, many experts believe that many clinical studies in children havenot been extensive enough. And adult doses are often not correct forchildren.The agency publishes a list of drugs for which pediatric versions areneeded. So far, the size of the pediatric market is not big enough to makeit profitable for companies to make special children's formulas of drugs fordisorders that commonly go along with obesity and high-fat diets. Thatappears to be changing.Madeira Therapeutics, based in Leawood, Kan., is formulating a liquid statinfor children that will be sold in either grape, cherry or bubblegum flavor,according to the company's chief executive, Peter R. Joiner.Madeira became interested in the drug to treat children with a geneticcholesterol condition, familial hypercholesterolemia, which strikes 1 in 500children regardless of their diet. The recent American Academy of Pediatricsstatement adds to the potential market, according to Mr. Joiner.The company, whose liquid statin may be available by late 2010, is alsointerested in a liquid oral diabetes medication."Because of the obesity epidemic in the United States, we see diabetes asanother important area for contribution," Mr. Joiner said.A nonprofit group in Cambridge, Mass., the Institute for PediatricInnovation, is working to encourage the reformulation of medications forchildren.Dr. Stephen P. Spielberg, the former dean of Dartmouth Medical School, isleading the effort."What we've learned over the years is that the way in which the body handlesmedicines, the half life of a medicine, how it's metabolized, how it'sexcreted by the body, does vary, from babies all the way up to adolescents,"Dr. Spielberg said.Hypertension medications present a particular challenge in dosing forchildren. "Even in clinical trials where adult pills were crushed and such,you often can't even demonstrate that the medication works," he added.Medco cautioned that hypertension data can be misleading because somechildren with attention deficit disorder are treated with hypertensiondrugs.The most significant increase in the use of drugs for children has been inoral medication for Type 2 diabetes. And some doctors believe much of thoseprescriptions were "off-label" use of the drug, metformin, to treatprediabetes, which may affect two million children nationwide.But some doctors object to the use of metformin for that purpose inchildren, even though studies have shown it may prevent diabetes in youngadults."There are no studies like this in children," said Dr. Tamara S. Hannon, apediatric endocrinologist at the Children's Hospital of Pittsburgh."The argument may be that we know what happens in adults, so the same shouldhappen in children. It's been proven untrue in several cases in the historyof medicine."Copyright 2008 The New York Times CompanyFAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. Suchmaterial is made available for educational purposes, to advanceunderstanding of human rights, democracy, scientific, moral, ethical, andsocial justice issues, etc. It is believed that this constitutes a 'fairuse' of any such copyrighted material as provided for in Title 17 U.S.C.section 107 of the US Copyright Law. This material is distributed withoutprofit. _____________Infomail1 mailing listto send a message to Infomail1-leave =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.