By Sharon Kirkey In early December 2003 Gordon Mitchell took a family vacation to Puerto Vallarta, Mexico. There, 16-year-old Gordon, born into the world five weeks too soon weighing less than two kilograms, swung his strong, young body from the cables in the canopy of trees in the foothills of the Sierra Madre mountains. At Christmas that year, Gordon laughed and joked with his cousins, and teased his grandmother, the woman with an instinctive connection with kids who let him smear face paint on her cheeks when he was little and eat Mr. Freezees for supper. Four days after Christmas, his parents and little sister Kaitlyn went swimming in the Aquatic Centre in Olds, Alberta, a town north of Calgary "born in the dust of new turned sod" the year the CPR railway was built in 1890. Gordon Mitchell stayed home, and killed himself. Gordon had been taking Paxil, an antidepressant his doctors prescribed for anxiety, up until two months before he took his life. The drug has since been hit with mandatory warnings of a possible increased risk of suicidal "ideation" and self-harm in children and adolescents, and a complete British ban on its use in children. The medical examiner's report revealed Paxil could still be detected in Gordon's body. His parents were not told the antidepressant has never been licensed for children in Canada, that it was being prescribed "off label" - meaning for a way not approved by Health Canada - or that its prescribing information cautioned doctors that safety and effectiveness in children under 18 "have not been established." Thousands of times a day in Canada a child is given a drug that hasn't been adequately tested on children, if at all. Drug labels frequently provide doctors with little to zero information on the drug's effectiveness, age-appropriate dose or safety in youngsters. For most drug classes, there is virtually no information on use in children under two. Now, after years of glacial progress compared to the U.S. and European countries, Canada is moving to improve drug investigation in children. Health Canada has proposed giving companies an extra six months patent protection - meaning more time without competition from other drug makers - for doing pediatric studies if their drug is likely to be used in children.
A similar - and controversial - provision passed by American drug regulators five years ago has already led to major changes in the dosing and safety information for certain drugs. Back in 2003, Gordon Mitchell's parents learned of the new warnings about Paxil only from media reports. It took two visits to convince Gordon's doctor to take him off Paxil. He was switched to Zyprexa - an antipsychotic that has only ever been studied in adults. He was also taking the anti-acne drug Accutane, which, again unknown to his parents, has also been linked with aggression and suicidal thoughts in users. "It's realistic to expect full disclosure when making decisions about your family's health," Gordon's mother, Joyanne, says. She believes that, while some of Gordon's struggles were due to his generalized anxiety disorders, "in retrospect, many, if not most, were due to the medications that he was on." Every parent, she says, should be told if a drug is being prescribed "off label" to their child, and family's should sign a consent form acknowledging they've been advised as such. "I didn't even know what 'off label" meant until Gordon died." In fact, fewer than 30 per cent of drugs used in children - from inhaled steroids for asthma to drugs to treat epilepsy, high blood pressure, nausea, attention deficit disorder and anesthetics to sedate children before surgery - have been tested in children, or tested in the age groups for which they're used. According to an article published last year in the Canadian Medical Association Journal, much of pediatric prescribing boils down to "educated guesses" about doses and safety. It's a dangerous situation, experts say, that can do two things: make physicians reluctant or afraid to use promising new drugs that may help a sick child, or expose kids to needless risks. The potential for a serious or life-threatening drug reaction is already greater in children than it is in adults, partly due to the fact they can't express their own response to a drug the way adults can. According to Health Canada data provided to CanWest News Service, between January 1 2001 and October 2004, 96 children in Canadian died of a suspected adverse drug reaction. In all cases, the death was listed as "died, drug may be contributory" or "died due to adverse reaction." The reports are based on suspicion only. But doctors say it's almost certain that the true number of deaths and serious injuries involving a drug side effect is much higher. Only about 10 per cent - and possibly as few as one
per cent - of serious or fatal drug reactions are ever reported. Many drug reactions are due to error: With so little information, doctors are left to calculate doses based on weight, and pharmacists to dilute drugs for children. That can lead to huge calculation mistakes, mixing up milligrams for micrograms, or misplacing a decimal - mistakes that no one notices because the amounts sound so small. "If you say, 'this baby needs a teaspoon of medicine, that sounds right. But what if what they really needed was one-tenth - .5 ml, instead of 5 ml?" says Dr. Michael Rieder, a pediatrician at the Children's Hospital of Western Ontario in London. He works in an adverse drug reaction clinic that treat about 600 children a year. The problem could be solved with more "pediatric-friendly" dosing, Rieder says. Yet drug testing in children has lagged so far behind that in adults that, until recently, medicines weren't even tested for palatability. Rieder once took a "whiff" of liquid cloxicillin, an antibiotic used to treat staphylococcus infections, when he was a resident, and swore he'd never prescribe it to a child. "It smells like vomit and doesn't taste nearly as good. Yet, it's still around." The extra half-year patent protection for drug companies that test new medicines on children is a start, he and others say. But that financial carrot does nothing to address the bigger problem of older drugs already on the market and no longer under patent protection. "Most drugs we use in children are in that category, from digoxin to morphine," says Dr. Gideon Koren, senior scientist in the Sick Kids Research Institute in Toronto and professor of pediatrics, pharmacology, pharmacy and medicine at the University of Toronto. "Morphine is now the number one, or close to it, drug for causing serious adverse events in children. It's used by thousands of kids every day after surgery, but if you open the product monograph, it says not recommended for young children because there is not enough (safety) data." He and other doctors and drug experts want stable funding for "meaningful" studies in all drugs commonly prescribed to kids, and greater vigilance in tracking drug reactions in children. And they're not waiting: Next week, an $8.4-million, nationwide project partly funded by Genome Canada will be launched that could make drug use for children safer worldwide. Specially-trained doctors, nurses, pharmacists and other health professionals from at least seven major children's hospitals will work together to monitor and report adverse reactions to drugs in
children, from rashes and dry mouth to drug-induced hepatitis, lupus and Stevens-Johnson-Syndrome, a rare and potentially fatal blistering, burning disease caused by an allergic reaction. "Instead of passively waiting (for drug reaction reports in children), we're hiring people to go out and find them, catalogue them, put them in a central registry and share them among hospitals to see if there are any patterns," says co-principal investigator, Dr. Bruce Carleton, of Children's and Women's Health Centre of B.C., and the U of B.C.'s Centre for Healthcare Innovation and Improvement. DNA and blood samples will also be collected from the children to help scientists in their search for genetic markers to explain why one drug is safe for one child, but not another. The ultimate goal is for a simple blood test that could be used to predict if a child is likely to react badly to a drug, and to individualize doses. The timing is important: Growing numbers of Canadian children are taking prescription medicines, and it's not just antibiotics for raw throats and sore ears. Investigators who tracked prescription drug use among more than one million Canadian children between 1999 and 2000 found four million "scripts" were dispensed during the 12-month study period, an average of 3.9 prescriptions per child. Overall, nearly 1,400 different drugs were prescribed, many outside the age ranges approved by Health Canada, and many for which no safety or efficacy data in kids exists. Antibiotics were dispensed to 76 per cent of children (with amoxicillin the leading antibiotic for all ages), followed by respiratory drugs, analgesics, anti-inflammatories (including the anti-inflammatory Celebrex) anti-psychotic drugs, stimulants, anti-depressants and anticonvulsants. "We estimate there are 100,000 children alone in Canada on an anticonvulsant," says Rieder, of the University of Western Ontario. Researchers know the delicate line they trend in pushing for more drug investigation in kids: raise awareness without raising unnecessary fear and anxiety among parents. For some, the prospect of more drug trials in the most vulnerable patients raises the fear of Mengele-like experiments. And there is no greater public relations nightmare for a drug company than having a child die during drug testing. "Society wants to protect children from being used as guinea pigs," Carleton says. "But in protecting them, we make them guinea pigs each and every time we use a drug, if we don't really understand how best to use it in a clinical setting."
"We need more basic information about how drugs are absorbed, distributed, metabolized and excreted in children. There's a huge risk (to a drug company) involved in the discovery of an adverse reaction. But there's also a huge risk to ignoring a potential risk. We found that out with Vioxx, didn't we?" Joyanne Mitchell and her husband, Jim, are now advocating for other children as a legacy to their firstborn, a "preemie" who grew into a wrestler, long-distance runner, football player and wake-boarder. They're preparing to launch a website to encourage parents to report adverse drug reactions and force changes to Canada's voluntary reporting system. "We were very involved and asked the right questions. Even when we phoned the hospital to ask for advice on symptoms (of a drug reaction) they couldn't, or didn't, advise us this (suicidal thoughts) could be an adverse reaction," Joyanne says. "Drug companies don't feel the terror of losing a child."
MEDIA LAW SEMINAR – SPRING 2014 LAW 851.511 Mondays, 1:30-4:15 p.m., AL109 Syllabus Instructor: Prof. Eric B. Easton Texts: Lively et al., First Amendment Anthology ; Friendly, Minnesota Rag ; Lewis, Make No Law ; Lessig, Code v. 2.0 ; Netanel, Copyright’s Paradox . Readings to be assigned. Office: AL526 Office Hours: Monday 4:15-5:15 p.m.; any time by appointm
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