Steve Anthony: True Canadian Pharmacy

p ‘In every instance, the published article made the drug look better than it would have. We cannot be certain that selective reporting was a decision made by employees of Pfizer and Parke-Davis, since the authors of the published reports included nonemployees, the researchers wrote. 3 billion US — including an unprecedented $1. According to the report, when a company-funded study’s primary finding wasn’t favorable, that result was usually buried !–more– and something else positive was highlighted, without disclosing the switch. This results in harm. Sidney Wolfe, head of health research at consumer group Public Citizen, called it the first comprehensive look at studies in which a company and people working for it so maliciously manipulated the data to make a drug look more effective than it actually was. In eight of the 12 published studies, the main outcome listed in internal documents differs from the one later given in the published report. Experts believe most Neurontin sales were for off-label uses — the ones in the reviewed studies. Sidney Wolfe
The documents used in the review were obtained by lawyers suing Pfizer for refunds on prescriptions paid for by insurers and consumers. ‘
— Dr. The study descriptions also list their primary and secondary outcomes. By last year, Neurontin sales fell to $387 million US due to cheaper generic versions sold as gabapentin. gov, to be eligible for publication. Pfizer disputes the report’s conclusions, saying the company never attempted to mislead the medical community about the effectiveness of the drug for certain uses. While doctors can prescribe drugs for unapproved, or off-label uses, drug companies are legally barred from promoting their products for such uses. The report appears in Thursday’s New England Journal of Medicine. 2-billion US criminal fine — for illegally marketing other blockbuster drugs. In every instance, the published article made the drug look better than it would have, said Wolfe, a member of the Food and Drug Administration’s drug safety advisory committee. We believe the review suffers from significant bias, insufficient data, poor methodology, and cannot pass the threshold of credible scientific research, Pfizer said in a statement. Sales peaked at $2. But they don’t always seek approval for those new uses, particularly if the new findings aren’t convincing. Drugmakers often test drugs for additional conditions and publicize the results. Arthur Caplan, director of the University of Pennsylvania’s Center for Bioethics, called the report one of the most ethically disturbing papers I’ve read in some time and an indication that people have been playing fast and loose with studies, particularly industry ones. epilepsy drug found that reporting of the results was often misleading, indicating the medicine worked better than internal company documents showed. Medical journals in recent years have required that studies be listed on a federal website, called ClinicalTrials. Its potential side-effects include suicidal tendencies and depression. In half the cases, a new primary outcome was substituted and in others, the original main outcome was instead reported as a secondary measure or wasn’t disclosed at all. One of the report’s authors is an expert witness for the plaintiffs; another has received fees from the lawyers. The studies were published in medical journals or presented at conferences, mostly over the last decade. Wolfe said there should be bigger fines and jail terms for manipulating study data, plus tougher rules for studies being published in journals. Dr. For the new review, the researchers examined 20 patient studies funded by New York-based Pfizer and its Parke-Davis unit on use of Neurontin for preventing migraines or treating nerve pain or bipolar disorder. The lawyers, who are seeking class action status for the cases, claim Pfizer concealed evidence the epilepsy drug Neurontin didn’t work for those unapproved uses, including nerve pain, migraines and bipolar disorder. Caplan said the FDA should have the power to audit industry drug studies. That move was made partly to make it harder for industry to hide studies on products that don’t pan out and only publish those with good results. Analysis of a dozen published studies testing possible new uses for a Pfizer Inc. The report, by researchers at the University of California at San Francisco and the Johns Hopkins Bloomberg School of Public Health comes two months after Pfizer was fined a record $2. Pfizer said it now has 1,245 company-sponsored studies listed on the website.
Neurontin was approved by the FDA a decade ago for treating seizures and later for pain caused by shingles — but not for other conditions. The authors cited some limitations to their review, including not knowing who made the changes. 7 billion US in 2004, when Pfizer paid $430 million US in government fines to settle allegations it improperly marketed the epilepsy drug for unapproved uses.

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Hundreds of natural health products could disappear from store shelves next spring because of a Health Canada backlog in approving licences, warns the Canadian Health Food Association.
We’re at a critical stage, said Carl Carter, director of regulatory affairs and policy development for the CHFA.
The biggest concern we have at this point is the standards of evidence Health Canada has been requesting for products’ efficacy, he told CBC News.
!–more– Firms that make and sell natural health products are not opposed to being regulated. In fact, they welcome the Health Canada stamp of approval, said Carter. However, he said the pendulum has swung too far in terms of proving that a drug works.

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When the blockbuster heart pill Norvasc lost its patent protection earlier this year, generic manufacturers couldn’t wait to get into the lucrative market for Canada’s third top-selling prescription drug, predicting they could save patients $180-million a year with their cheaper copies.
But the Saskatchewan government has just awarded its first contract for a generic version of the medicine to a generic branch of Pfizer, the pharmaceutical giant !–more– that makes Norvasc itself, feeding concerns that such tendering systems will become the norm and inadvertently leave Canadians paying much more for prescription drugs.
Pfizer lost a drawn-out court battle recently to try to keep its patent-protection in force longer and delay any generic competition for another year.
Like other brand-name companies, though, the world’s largest pharma firm sometimes enters the generic market when its drugs go off patent, and its GenMed division offered Saskatchewan’s drug plan the lowest price among the eight competitors that started selling copies of Norvasc when the patent expired last week.

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p But as of Tuesday, three new groups were eligible for the H1N1 vaccine:
As of Tuesday, Nova Scotia had received 207,400 doses of H1N1 vaccine and about 15 per cent of the population has been inoculated. Dr. Once the vaccine was restricted to only priority high-risk groups, the company offered to give the vaccine back but was turned down, said Derek Estabrook, vice-president of marketing for Farmers Dairy. Vaccination clinics in the province !–more– are closed for Remembrance Day, though flu assessment centres are still open. Ultimately, all Nova Scotians are at some risk, so while it’s not following our current rules, they were given the vaccine under a different set of rules and we just need to keep using it, Strang said. It’s far better they just keep using it than just have it sit in the fridge unused. Robert Strang, Nova Scotia chief public health officer
The company requested the doses weeks before the current restrictions were put in place, when the Department of Health allowed big employers to look after the vaccination of their own staff. Robert Strang, the province’s chief public health officer, said it’s a matter of quality control, and the dairy company did the right thing by using the doses. A major dairy company serving Atlantic Canada did nothing wrong in immunizing employees against swine flu even though they weren’t a priority group, Nova Scotia public health officials say. Estabrook said the company was told there was no guarantee the doses had been kept at the proper temperature. —Dr. Nova Scotia narrowed the list of people who can get the shot to only priority groups because of a Canada-wide vaccine shortfall. About 100 Farmers Dairy employees in Hammonds Plains and Truro received the H1N1 shot on Monday, including those outside the announced high-risk categories. Strang said it could take until February before all Nova Scotians have access to the vaccine. Health said that they could not take it back and that we should use our best judgment and administer it from there, he said.

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p Regina General Hospital is $1. When the lab is in place, the region hopes it will be able to recruit more specialists to diagnose and treat such patients. The lab would fill an urgent need in southern Saskatchewan, the foundation says. The donation, aimed at establishing an electrophysiology lab at the hospital, was announced Thursday by the Kinsmen Telemiracle Foundation. The new lab will diagnose and treat arrhythmias, which are life-threatening !–more– abnormal heart rhythms. Currently, arrhythmia patients in south Saskatchewan are given medication — considered an inadequate treatment — or are sent out of province for treatment, the health region says. Last year, around 700 patients were admitted to the Regina Qu’Appelle Health Region for atrial fibrillation, the most common type of arrhythmia. 25 million closer to building a laboratory to help people with heart rhythm disorders. Electrophysiology concerns problems related to electrical activity of the heart. George Garbe, the section head of cardiology for the health region, said in a release. Heart rhythm abnormalities are a major cause of death and disability in heart patients, Dr.

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p News of the pending amendment, to be introduced when the health-care reform bill makes it to the Senate floor, has alarmed some Canadian observers who fear re-importation could lead to shortage of drugs in Canada. law, only pharmaceutical companies are allowed to import prescription drugs approved by the Food and Drug Administration into the United States. Consequently, Dorgan has long maintained, Americans pay higher prices for prescription drugs !–more– than anywhere else in the world. Bennett herself raised that concern in her testimony on Wednesday.
My goal over time is for us not to pay more than you, because you set prices and cause us to pay more when we’re doing all the innovation, Corker added. S. S. Drug companies import more than US $40 billion in drugs into the United States, while drug wholesalers and consumers are shut out of the global marketplace. Please don’t think that you can import cheap drugs from Canada … it will last us about 36 days, she told Corker. Dorgan will introduce an amendment to the health-care reform legislation currently before the Senate finance committee that would legalize so-called re-importation. He replied: That’s a silly way of dealing with it. Under current U. It’s the drug companies, sir, and they’re multinational — it’s nothing about the United States of America, she told him. In essence, the Canadian government and its citizens are taking advantage of our citizens by virtue of setting prices that are lower than competitive prices. One of the things that has troubled me greatly about our system is the fact that we pay more for pharmaceuticals and devices than other countries, and yet it’s not really our country so much that’s the problem, it’s the parasitic relationship that Canada and France and other countries have towards us, the Tennessee lawmaker told Carolyn Bennett. … You benefit from us, and we pay for that, and I resent that. The panel, chaired by Democratic Sen. Democratic senator Byron Dorgan from North Dakota is preparing to make a legislative push in the days to come that would legally allow Americans to buy cheaper Canadian drugs. Their debate comes as U. Senate committee. Herb Kohl and including newly minted Sen. She seemed puzzled by Corker’s remarks, reminding him that drug pricing was a global concern, not part of a plot by Canada.
Canada benefits financially from America’s role as a world leader in medical advances, Republican Senator Bob Corker charged in an exchange with a Liberal MP as she testified before a U. S. An American legislator called Canada parasitic on Wednesday for siphoning U. Al Franken, was examining how successful health-care systems keep their costs low while maintaining quality care. dollars to Canada with low prescription drug prices while his country does all the innovation.
Bennett, a family doctor and one-time minister of state for public health, was one of five people testifying before the Senate special committee on aging. Meaning that you set prices and unfortunately all the innovation, all the technological breakthroughs, just about, take place in our country. S.

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p Canadian researchers have used computer modeling and international aviation data to predict infectious disease outbreaks by tracking patterns of travel between countries. Any air that’s been recycled through so called HEPA filter will be clear to all intents and purposes of any harmful viruses or bacteria, Evans said. The Public Health Agency of Canada and the World Health Organization are studying the research. Anthony Evans, chief of aviation !–more– medicine for the Montreal-based International Civil Aviation Organization. We’re able to look at the air transportation network and … predict very accurately, no matter where a disease shows up in the world, we can say where it’s going to go, said Gardam. Michael Gardam, director of infection prevention and control at Toronto’s University Health Network. Passengers may worry viruses will spread around planes in recirculated air, but that isn’t a concern thanks to the high efficiency particulate filters that catch microbes, said Dr. Jets transport two billion passengers every year, and can take a disease anywhere on Earth within 48 hours. In the early stages of outbreaks of both SARS and the H1N1 pandemic, people who weren’t showing symptoms carried the viruses to unsuspecting countries. The real risk, whether on a plane or at a theatre, comes from being in close contact with someone who is infected, he said. It’s too late to use travel restrictions on airline passengers to stop the spread of the H1N1 virus, but the findings could help health agencies to get a jump on the next viral threat, said study co-author Dr. Air travel doesn’t pose extra risks for individuals, infectious disease experts say, but it does spread diseases between populations.

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p That’s because fashion is so much more important to us [women], said Dufour, laughing at the contradiction. There’s not a whole lot of different shoes that men can wear that aren’t flat, she said. Researchers found one-quarter of participants reported generalized foot pain on most days, with 19 per cent of men and 29 per cent of women falling into this category. Yet even the lead researcher admitted she would not likely stop wearing heels, !–more– despite the mounting evidence against them. The study will be published in the October issue of the journal Arthritis Care Research.
The study offered one unexpected finding in that women reported pain only in their hind foot.
The study analyzed data from 1,900 women and nearly 1,500 men enrolled in the Framingham Foot Study between 2002 and 2008. The study is one of the first to examine the association between footwear beyond just high-heel use and foot pain. There’s nothing to hold your foot in. High-heels, pumps, sandals and slippers were classified as poor. Women who regularly wear high heels can expect to suffer heel pain as they age, according to a study from a Harvard-affiliated institute. They found no significant link between foot pain and the types of shoes men wear, something that did not surprise Dufour. The real issue is designing a good high heel that is affordable. She would like to see her research used by shoe designers and manufacturers. Hard- or rubber-soled shoes and work boots were average, and athletic and casual sneakers were good. According to this newest study, it’s not just high heels. Flip-flops are terrible for your feet. High heels need not be so damaging, said Dufour, but sadly, good high heels — those that offer good padding and strong support — are very expensive. The flattest of the flat shoe, the flip-flop, is one of the worst shoes a woman can wear, said Dufour. Dufour, a graduate student at the Institute for Aging Research of Hebrew Senior Life. Eleven shoe types were considered. Past studies have shown women who wear high heels are more likely to fall or develop a variety of painful, degenerative muscle and joint diseases. More than 60 per cent of women reported wearing poor shoes in the past, compared to only two per cent of men. Dufour said she and her researchers had expected more reports of pain all over the foot. In her own experience, she finds the ball of her foot become sore when she wears heels. I thought about it after I started doing all this research and seeing pictures of feet disfigured by wearing bad shoes, but no, I haven’t given anything up, said lead author Alyssa B. The researchers say past shoe-wear among women is a key factor for hind-foot, or heel, pain.

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p
At one point, the family took the boy to the emergency department of an Edmonton hospital, where he was later admitted to the psychiatric unit, Phillips said. On Sunday, police found the bodies of the man, 39, and the boy in a home in northeast Edmonton, after they received a call from the man’s common-law wife. The case highlights a lack of emergency services to help the families of autistic children, Phillips said. She was worried because !–more– she couldn’t get in touch with him. The family had become desperate for help because the little boy had become difficult for the family to manage, said Karen Phillips, who works with the Autism Society of Edmonton Area. They try their best, but they’re not trained in autism and the doctors there will say clearly, this is not the place for children with autism. The boy was autistic and had been living at a group home. (CBC)
The deaths of a man and his 11-year-old autistic son on Sunday were the result of a murder-suicide, Edmonton police said Tuesday, after receiving confirmation from the Edmonton Medical Examiner’s Office. There is no emergency service. The dad just felt he couldn’t do it any longer and he just didn’t think he could get the help he needed. Eventually, a place was found for the boy in a group home, but that search was a struggle, because many group homes are not set up to deal with autistic children with extreme behavourial problems. Karen Phillips, from the Autism Society of Edmonton Area, worked with the family.
Families are told to call police who in turn will take the child to the psychiatric unit of a hospital, but the staff there don’t have the kind of training required to help the child, Phillips said. , they found the man and the boy dead in the basement. They will also not be releasing the cause of death. They would think, ‘none of us could cope with that. When officers arrived at the home around 12:42 p. Police said they will not be releasing the names of deceased in order to protect the privacy of the family and to protect the identity of other children in the family. behaviourally out-of-control children with autism. ‘ But it’s an everyday occurrence for families who have. . . So parents are stuck at home with their children in situations that, if the general public knew, they’d be appalled, she said. Phillips had worked with the family and said the mother asked her to share their story.
The government was working on emergency respite services for families, but recent cutbacks mean the plans have been put on hold, she said. m. To say that this can’t happen for other families, Phillips said as her eyes welled up with tears talking about the tragedy. They’re very good. But the staff there weren’t equipped to help a child with autism.

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p If a boy is in the 30th percentile for weight then 70 per cent of children his age weigh more than him. There is something real and important going on here — something that, despite the overgrowth of children that is characteristic of the obesity epidemic and the sprouting of adult-type cardiovascular diseases in children related to excess weight, makes parents still more worried about underweight than overweight, even now, Jain wrote. S. !–more– Previously, Canadian researchers have expressed concerns over whether standardized growth charts that were based on European newborns reflect healthy growth for babies of south or Chinese ancestry. study suggests. Since the two dimensional lines and plots are not speaking a language that parents understand, Jain suggested using other approaches to getting parents to see when a child is underweight, overweight or obese, such as measuring abdominal circumference or discussing weight in terms of clothing size. But only 64 per cent could tell a child’s weight when shown it plotted on a growth chart in response to multiple-choice questions, Dr. For example, if a girl who is in the 90th percentile for height, she is taller than 90 per cent of other children her age. Elana Pearl Ben-Joseph of Nemours Center for Children’s Health Media in Wilmington, Del. The Canadian Pediatric Society is currently updating its guidelines on growth charts. , and her colleagues reported in the October issue of the journal Pediatrics. S. Centers for Disease Control and Prevention, World Health Organization and pediatric health-care groups in Canada encourage parents to use growth charts as monitoring tools.
About one-third of parents could find a child’s age, weight and percentile on a chart and define percentile correctly. However, just over half of parents were unconcerned about a very overweight child in the 10th percentile for height and 90th percentile for weight, Anjali Jain of the Children’s National Medical Center in Washington said in a journal commentary accompanying the study. This finding is significant because many parents prefer to be shown growth charts by their health-care provider, and many parents report recording their children’s measurements on growth charts at home. Parents often ask pediatricians to see their children’s growth chart but many don’t seem to know how to interpret the information, a new U. schools are calculating students’ BMI or weight-to-height ratios in an effort to fight childhood obesity. S. Percentiles are used on a growth chart to show how a child compares to his or her peers. Although growth charts are used frequently as visual aids to educate parents about their children’s growth, many parents cannot comprehend the data, the study’s authors concluded. In an online survey of 1,000 parents, 64 per cent of respondents said it was important to look at growth charts to see how their child was growing, and 40 per cent said they needed to see it to confirm what the health-care provider said verbally. The findings showed a well-proportioned short and light child was fretted about. The U. Some U.

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