Posts Tagged ‘Health Canada’

Canada’s soon-to-launch clinical trials database: how does it measure up?

By Julia Belluz - Monday, May 13, 2013 - 0 Comments

Neeta Lind / Flickr

Any day now, the Canadian government is going to announce a website that federal health minister Leona Aglukkaq is calling a coup for transparency and patient access. The soon-to-be-launched database of clinical trials happening in Canada will go live before the end of May (Health Canada could not confirm the date), which means Canadians will soon have a one-stop shop for information about what pharmaceutical products are being tested on humans in this country.

Before your eyes glaze over at what sounds like a regulatory snooze fest, know that how our government regulates clinical trials impacts anyone who uses or prescribes pharmaceuticals. It also affects all those brave souls who give their bodies over to science in the hope that they’ll not only get help with an ailment, but also contribute to the advancement of knowledge about treatments and human health.

Right now, it’s estimated that about half of all trials run globally never see the light of day. This is because scientists—both independent and those working for the pharmaceutical industry—are more inclined to publish studies about drugs that have positive results, a phenomenon known as publication bias. As Sir Iain Chalmers, a British researcher and one of the founders of the Cochrane Collaboration, asked, “How many (patients) would have agreed to participate (in a trial) if researchers had told them, ‘If the results of this trial don’t serve our academic or commercial interests we won’t make them public?’”

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  • Gov’t says new cars will need shoulder belts for rear centre seats

    By The Canadian Press - Thursday, February 14, 2013 at 2:09 PM - 0 Comments

    OTTAWA – All new cars built in Canada as of September 2015 will come…

    OTTAWA – All new cars built in Canada as of September 2015 will come equipped with shoulder safety belts for the rear centre seat, a change that’s part of an alignment of auto safety regulations in Canada and the United States.

    New crash test standards are also being adopted that could both improve automotive safety and save car makers millions of dollars, Health Minister Leona Aglukkaq said Thursday as she took part in announcing the changes.

    “Seat belts do save lives,” Aglukkaq said. “Improving (seat belts) based on new tests and whatnot is important and we need to continue to do that.”

    On top of adding a mandatory requirement for lap and shoulder seat belts in the rear centre seat, new crash test standards are being adopted.

    Car makers will have to use female and child-sized dummies in their crash tests, says Transport Canada.

    Those tests must also be conducted at higher speeds for front-end crashes and improvements will be required in air bag deployment testing.

    Canada has good auto safety regulations now, but more can always be done, Transport Minister Denis Lebel told the news conference at a department testing facility in Gatineau, Que.

    “We’ll continue to improve our safety (tests) day after day,” Lebel said. “We have very strong regulations and we will continue to work on that.”

    The changes are being made to bring Canadian safety standards in line with those already adopted in the United States, under an agreement signed in February 2011 by Prime Minister Stephen Harper and U.S. President Barack Obama.

    The move to align regulations will mean big savings for the automotive manufacturing sector, said Kash Ram, director general of Transport Canada’s road safety and motor vehicle regulation division.

    “Costs are expected to decrease because the manufacturers would not have to test to a unique Canadian requirement,” Ram said. “Typically for any of these standards there are millions of dollars in expenses involved.”

    Older model cars will not have to be retrofitted with shoulder belts.

  • Health Canada pulls licenses for pregnancy, drug tests sold by B.C. company

    By The Canadian Press - Friday, February 8, 2013 at 6:39 PM - 0 Comments

    DELTA, B.C. – Health Canada has pulled the licenses for all medical devices sold…

    DELTA, B.C. – Health Canada has pulled the licenses for all medical devices sold by a Delta, B.C., company, including home test kits to detect pregnancy and ovulation.

    IND Diagnostic sold the kits directly or through 13 private label manufacturers, but Health Canada became concerned after learning the company was importing unlicensed products for export to other countries.

    Among the company’s products are kits for screening for urinary tract infections, infectious diseases and illicit drugs and some were sold for home use in retail outlets, including dollar stores, while others were sold only for use by health professionals.

    Health Canada says in a news release the decision to suspend the medical device licenses for the products means they cannot be sold legally in Canada, though the department says it is not aware they ever were.

    The department also says the decision to suspend IND’s licenses is not based on any identified issue with the safety or effectiveness of the products, though it urges anyone with complaints about the products to call 1-800-267-9675.

    A person answering the phone at the company, who refused to be identified except as an employee, said the company is seeking legal advice and he declined further comment.

  • Bureaucrats concerned with drug-shortage plan later backed by minister

    By The Canadian Press - Thursday, December 27, 2012 at 7:30 AM - 0 Comments

    TORONTO – The federal health minister’s move to let drug makers voluntarily alert doctors…

    TORONTO – The federal health minister’s move to let drug makers voluntarily alert doctors and pharmacists of medication shortages went against concerns the approach could put Canada’s drug supply at risk, documents show.

    Civil servants at Health Canada warned in February of last year that the voluntary-notice option subsequently chosen by Leona Aglukkaq was “susceptible to bad company behaviour” because there would be no way to punish manufacturers who fail to report production gaps that leave health practitioners scrambling to get drugs to their patients.

    Three weeks later Aglukkaq wrote to drug industry associations requesting they voluntarily release information on the increasingly common problem of medication shortages.

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  • Heartburn pills that cause heart attacks, antidepressants that lead to suicide

    By Anne Kingston - Tuesday, November 20, 2012 at 5:10 AM - 0 Comments

    Why does Canada trail U.S. and EU in protecting citizens from dangerous meds?

    JENNIFER ROBERTS

    On Oct. 17, 2012, Terence Young’s tireless 12-year crusade took him before a Senate committee looking into the safety and regulation of prescription drugs in Canada. The Conservative MP for Oakville, Ont., gave the panel an earful. “Doctors and patients have no way to know when a drug is safe and when it is not,” he argued, noting that his own government’s drug monitoring system is “primarily in the hands of the big pharma companies themselves, even as a growing number of injuries and deaths are reported related to their use.”

    Young was there not as a politician but as a father seeking to redress colossal systemic failure—a mission dating back to March 19, 2000, the day he watched his 15-year-old daughter Vanessa collapse on the floor at home. She was rushed to hospital, where she died a day later. The cause: cardiac arrest.

    None of it made sense. Vanessa was a healthy girl. She didn’t drink or smoke or take drugs— with one exception: over the past year, she had periodically taken cisapride, an acid-reflux drug marketed as Prepulsid. Her doctor, who’d diagnosed her with a minor form of bulimia, prescribed it after she complained of reflux and feeling bloated after meals. Neither their doctor or pharmacist mentioned risks; her parents considered it “super Rolaids.”

    But when Young dug deeper, he found cisapride was far more toxic than the heartburn it treated: it was linked to 80 deaths in Canada and the U.S. and had generated a total of 341 “adverse reaction” reports in the two countries. More shocking to the former Ontario MPP, Health Canada knew of these risks: since approving Prepulsid in 1990, the agency, which approves and monitors prescription drugs through its Therapeutic Products Directorate, had sent four letters to doctors, the last in 1998, warning about serious adverse effects, including heart risks in children, women and infants.

    Had the family lived in the U.S., Young learned, Vanessa might not have been prescribed cisapride. In 1998, the U.S. Food and Drug Administration (FDA) had given it its ominous “black box” warning, an alarm bell that makes doctors far less likely to prescribe a drug. In January 2000, two months before Vanessa died, the FDA issued an advisory alerting doctors of heart attack risks and rewrote label warnings; in April, it announced cisapride would be pulled from the market in July 2000. Health Canada followed suit that May, taking Prepulsid off the market in August.

    In 2001, Young marshalled his political connections and demanded an inquest into Vanessa’s death; the 16-day hearing resulted in 59 recommendations, including mandatory reporting of adverse drug reactions by health care professionals and clearer label warnings. A Canadian Medical Association Journal (CMAJ) editorial on the inquest’s findings noted Vanessa’s death was “undoubtedly caused by cisapride” and criticized Health Canada’s response as another example of its “advisory and regulatory actions lagging behind the FDA’s.”

    Young also launched a $100-million class-action suit, naming Janssen-Ortho Inc., Prepulsid’s marketer, Johnson & Johnson, its parent company, and Health Canada. And he filed an individual suit against all three parties. The six-year battle, settled out of court, is chronicled in his book Death by Prescription: A Father Takes on his Daughter’s KillerThe Multi-Billion Dollar Pharmaceutical Industry, published in 2009.

    His journey into the netherworld of Canadian drug surveillance revealed a system structured to serve the interests of the industry it regulates before the public it’s entrusted to protect. Under the “user-fee” model adopted in 1995, drug companies pay to submit a drug for approval and provide the supporting research. The result is an industry-regulator alliance primed to bring drugs to market. Health Canada has an online database listing adverse reactions to drugs. But navigating it is next to impossible, and reporting adverse effects is voluntary for doctors and pharmacists. Even if a drug is found unsafe, the agency lacks the authority to unilaterally revise the label or remove it from market—or order a company to do so.

    Young’s quest to improve drug safety spurred his entry to federal politics. In 2009, a year after he was elected, he tabled a private member’s bill calling for an independent drug-monitoring agency with the power to order unsafe drugs off the market and issue plainly worded risk warnings. It won’t be debated until late next year, at the earliest.

    Sitting in his constituency office in October, Young expresses incredulity that prescription drugs aren’t regulated as stringently as other public safety threats: “The minister of transportation doesn’t ‘negotiate’ with truckers to keep unsafe vehicles off roads,” he says. By law, doctors must report unfit drivers, and are paid to do so. Fast-tracking drugs to market is like “air-traffic controllers being told to land planes more quickly,” he says. Eleven years after his daughter’s inquest, none of its major recommendations have been implemented, he says: “Nothing has changed since Vanessa died. It has only gotten worse.”

    Vanessa Young’s tragic death thrust her into a big, undiscussed demographic: the 10,000-plus Canadians estimated to die each year from a prescription drug taken exactly as prescribed. And that figure is likely a gross understatement: it is extrapolated from a 14-year-old study, led by University of Toronto researchers and published in the April 1998 Journal of the American Medical Association, that found deaths linked to prescription drugs accounted for some 106,000 fatalities annually in the U.S., making it the fourth-leading cause of death, behind cancer, heart disease and stroke. A 2011 Health Council of Canada study additionally estimated that 150,000 people annually experience serious reactions from prescription drugs.

    Those numbers are destined to rise given a market growing by $1 billion a year, according to the Canadian Institute of Health Information (CIHI), which estimates that Canadians spend nearly as much on prescription drugs ($26.9 billion) as on doctors. These medications can improve and save lives. But they’re increasingly prescribed from cradle to grave for an expanding list of syndromes, dysfunctions and disorders—infant reflux, ADHD, adult ADD, social anxiety disorder, female sexual arousal disorder—as well as new health “risks” to manage, such as high cholesterol.

    When concerns are raised about prescription drugs, they invariably focus on misuse or abuse: sports doping, OxyContin addiction, teenagers taking parents’ pain meds to get high. That more Canadians are harmed or killed by drugs taken as prescribed than by tainted meat, tainted water and handguns combined is not a blip on the public radar.

    But this is changing: a growing number of voices are putting the spotlight on the risks of “proper” drug use. At the Senate committee hearing, Janet Currie, a social worker with the Victoria-based Psychiatric Medication Awareness Group, called prescription-drug side effects “one of the most serious public health problems we have.” Physician David Juurlink, a drug-safety expert and scientist with Toronto-based Institute for Clinical Evaluative Sciences, agrees: “It’s an enormous problem,” he says.

    Two new books—Pharmageddon, by Irish psychiatrist David Healy, and Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients, by British doctor Ben Goldacre—present scathing critiques of the $800-billion pharmaceutical industry, including evidence of its routine suppression of negative clinical trial results, something Goldacre calls “a global scandal that puts patients at risk.” The issue was raised in British parliament last month as Conservative MP and family doctor Sarah Wollaston accused drug companies of burying bad news about medicines’ effectiveness and side effects.

    Meanwhile, the problem continues to grow. The need for change is reflected in a Canadian study that reveals that serious drug dangers are frequently identified after they come to market. Almost one-fifth (19.8 per cent) of 434 new active substances approved by Health Canada between 1995 and 2010 were later given serious safety warnings—some only months after approval—Joel Lexchin, a physician and professor in the school of health policy and management at Toronto’s York University, found. The study, published last month in the Archives of Internal Medicine, shows risks are higher for drugs fast-tracked in 180-day “priority reviews” (versus the 300-day norm): 34.2 per cent had serious warnings.

    Clinical trial results offer a rosy, unrealistic picture of how a drug works, says Juurlink: “In the real world, we don’t monitor people as closely and we don’t select people as carefully. And we don’t apply the same restrictions to a drug’s use.” No one should think a new drug is safe, he says. “Most are overhyped and brought out to maximize appearance of benefit and minimize harm.” Recognizing this, Britain puts an inverted black triangle on new drugs and advises all adverse reactions be reported, says Lexchin: “It’s an extra indication not a lot is known about safety, so be on the lookout.” Pulling drugs from market is rare. One notorious exception was the arthritis drug Vioxx, fast-tracked in 1999 despite known risks; it was removed in 2004 amid a flood of lawsuits after at least 55,000 deaths worldwide. According to Lexchin, only 55 prescription drugs have been withdrawn in Canada for safety reasons since 1963 (Health Canada doesn’t keep track of this data). In comparison, there were 4,852 prescription drugs on the market as of September 2012; 410 new prescription drugs came to market in 2011.

    Far more common is a wallpapering of additional warnings that doctors often can’t keep on top of, or find readily on Health Canada’s website. Champix, a popular smoking-cessation drug, for example, was linked to risk of suicide, heart attacks and angioedema, a life-threatening condition characterized by swelling of the skin—all within a year of its 2007 approval. In May 2010, Health Canada and manufacturer Pfizer released a new safety warning telling users with “neuropsychiatric symptoms or behaviours that are not typical for the patient” to stop taking the drug and talk to their doctor. By then, France had stopped insuring it, and doctors in the U.S. were demanding it be pulled from market. In June 2011, Health Canada announced “an ongoing review” that concluded this year with new “precautions for patients with respect to cardiovascular safety.” Even while under review, Champix ads ran with an upbeat “I did it!” tag line, marketing not allowed in the U.S., where stricter rules surround “black box” drug advertising. As of this month, MedEffect Canada’s database lists 1,940 adverse reaction reports for Champix, including 33 “completed suicides.” Yet it’s covered on the formularies of seven provinces, five of which took it on after June 2011.

    Drug side effects can end up triggering a “cascade of risks,” says Alan Cassels, a drug policy researcher and professor at the University of Victoria. He points to cholesterol-lowering drugs, or statins, such as Lipitor, Zocor and Crestor, the most widely prescribed drugs in the world. They’re prescribed to manage heart-attack risk, rather than an actual condition, but come with common side effects—muscle pain, anxiety and Parkinson’s-like symptoms—that lead doctors to prescribe additional drugs, with side effects of their own. Cassels wrote of the accumulated risks in July: “Some day, I suspect, we will regard statins as an unmitigated scandal in medicine.”

    Eking out patterns of risk is difficult and can take decades, says Juurlink. A study he led, published in the CMAJ in August, tracked 144 patients aged 66 and older who were admitted to Ontario hospitals with acute liver damage; none had a history of liver disease but all had started taking one of five broad-spectrum antibiotics within the previous 30 days. Eighty-eight—61 per cent—died in hospital. The study, which required nine years of data to confirm a pattern, concluded that two specific antibiotics—moxifloxacin (brand name Avelox) and levofloxacin (Levaquin)—“were associated with an increased risk of acute liver injury” in older people, compared with clarithromycin. Hospital records didn’t provide a cause of death, and nobody would think to associate it with antibiotics, Juurlink says. “But I think it’s fair to speculate that the majority of them died of the consequences of their liver injury.” Risks of undetected prescription drug death is highest in older people, he says.

    Because deaths linked to prescription drugs are considered to be from “natural causes” in hospital records and coroners’ reports, they’re impossible to trace. That’s something Terence Young wants to change. In 2009, he appeared before an Ontario committee to ask for a new category of death: “related to a medical treatment including a drug prescribed or otherwise recommended by a medical professional.” He was shot down. Coroners can keep drug-related deaths under the radar, Young says: “It’s a conspiracy of silence. They’ve been content to cover up medical errors and harmful drugs for years.”

    Yet to hear Health Canada tell it, Canada’s drug regulatory system is not only competent but world-class. Last month, Health Minister Leona Aglukkaq (who declined an interview request from Maclean’s) told the Toronto Star that our drug regulatory system is “one of the safest and most rigorous in the world.”

    Many disagree, vehemently. “France and even the United States have regulatory regimes that are much more rigorous and safe,” says Cassels. Juurlink calls Health Canada “a lot of bureaucracy with very little independent action compared to the U.S. and Europe.” The 2011 auditor general’s report criticized the agency for lack of transparency regarding drug approvals, clinical trial data and the status of drugs “approved with conditions,” and for taking years to report safety issues.

    The FDA and the European Medicines Agency have made far bigger strides in transparency. In 2010, the FDA adopted “plain language” labelling, something Health Canada has talked about for a decade. The value of clarity is evident in the U.S. monograph for antidepressant Paxil: it refers to “suicidality” at the top in bold type in a black box, plus “risk of increased suicidality” in people under 24 and “the need for close observation.” The Canadian version only starts mentioning anything relating to suicide on page six of its 55 pages.

    Extracting information from Health Canada is an exercise in frustration. Drug company information is protected as commercial “trade secrets,” which means it’s withheld from the public. Health Canada spokesperson Sean Upton said many of Maclean’s questions (such as, “How many drugs were approved under ‘priority review’ in 2011?”) would require access to information requests, which can take years, and yield nothing—although he responded a month later saying there were eight. The FDA has the corresponding information on its website, for all to see. Asked what Health Canada did with “adverse effect” reports, Upton responded with boilerplate: they are “systematically monitored to identify rare, new or unexpected adverse reactions,” he said.

    Juurlink says that’s a joke. Post-market monitoring of drugs is “a national embarrassment,” he says, calling MedEffect an “electronic dumpster.” As a trained pharmacist, he has trouble navigating it, unlike the FDA’s site. And if reporting of adverse effects by health care professionals was mandatory, as it is in France, Sweden, Spain and Norway, he says, we’d have better data. Cassels estimates 90 to 99 per cent of adverse reactions are never reported.

    The lack of transparency runs through the entire drug-approval chain. The FDA, for instance, reveals what clinical trial data was used to support a drug’s approval; Health Canada doesn’t. “It might get a dozen studies and three are favourable and that will be the basis of the approval, but they won’t tell you,” Cassels says. Instead, the agency releases a “summary document” that omits key elements, Lexchin says. “They don’t tell you what trials were submitted, what information confirmed safety and efficacy, the number of people in the trials, the number of subjects who dropped out due to bad side effects.” Data on dropouts is crucial, he says; they’re the first indication that safety problems exist.

    Such opacity keeps doctors in the dark, says Matthew Herder, a lawyer and professor at Dalhousie University’s faculty of medicine. In an article published in the CMAJ last year, Herder cites Health Canada’s failure to publicly disclose in 1999 that selective serotonin reuptake inhibitor (SSRI) antidepressants were not authorized to be given to people under 19. By 2004, he notes, SSRIs were widely prescribed “off-label” for teens by physicians who hadn’t been apprised of the risks. Health Canada later claimed the information constituted “confidential” trade secrets, and so couldn’t be divulged by the agency. (“There are no legal boundaries preventing disclosure,” Herder told Maclean’s.)

    Health Canada trails regulators in the U.S., Europe, Australia, Brazil and India, who have made registering clinical trials mandatory, a bid to prevent companies from burying negative data. Last month, it announced it was setting up a “web-based list” of Canadian clinical trials—which drew criticism that registration still isn’t mandatory.

    “It’s a dysfunctional system,” says physician and pharmacologist Michele Brill-Edwards, who headed Health Canada drug approvals between 1987 and 1992 and quit in 1996 after blowing the whistle on the agency’s suppression of prescription drug risks; she won a 1992 federal court case against her employer. Industry influence only grew as Health Canada switched to the user-fee model in 1995, Brill-Edwards says. Even the language is telling. Internal emails from the period refer to the industry as “the client,” and the job once done by the Health Protection Branch now fell to the mercantile-sounding Marketed Health Products Directorate. A regulator biased to industry interests puts patients at risk, Brill-Edwards says: “The industry’s quest is to get that drug out there and get it used as much as possible. But the more widely we use a drug, the greater the risk that we’re going to end up giving it to people for wrong reasons in ways that will harm them.”

    Canada’s small market is a disadvantage when negotiating with industry, she says: “The FDA has a far bigger stick.” But a strong health minister could do it, she says: “You could demand plain-language labelling. They’re already doing it for the U.S. market.”

    Drugs produced primarily in offshore factories add another layer of risk, says Cassels, who wrote on the topic in the October 2012 CMAJ. He asked Health Canada about how it monitors this, only to be told it conducted 35 inspections from 2006 to 2011; the agency wouldn’t say which countries were involved or reveal its findings, citing proprietary trade secrets. “That’s a bulls–t excuse,” Cassels says. “Whose team are they on?” He’s doubtful the agency is up to the task, especially after recent budget cuts: “If they can’t or won’t regulate drug advertising, what’s the chance they’ll go to the backwaters of China?”

    For now, the task of advocating for better drug regulation continues to fall to those, like Young, whose advocacy is born of tragedy. In November 2010, Nancy and Shaun McCartney’s 18-year-old son, Brennan, went to their family doctor in Bolton, Ont., with a chest cold. The extroverted high school student mentioned feeling sad over breaking up with a girl he’d been seeing for three months. He left with a script for an antibiotic, a puffer— and a sample pack of Cipralex, an SSRI antidepressant. Nancy, a high school vice-principal, expressed concern; Brennan had no history of depression. He assured her the doctor said it would help. On the fourth day taking it, Brennan seemed agitated when he left the house, his mother says. He failed to come home. The next day his body was found. He had hung himself in a local park.

    Sitting at their kitchen table, Nancy flips through a binder documenting systemic failure. Brennan wasn’t given the full drug monograph that mentions suicide risk; the sample pack (she has the brochure) notes only “self-harm.” There’s also correspondence with the coroner’s office denying the McCartneys’ request for a toxicology scan. They’ve sent a forensic sample to Australia. “We’ve lost trust in the Canadian health care system,” Nancy says. “Until people have been in our shoes,” says Shaun, “they can’t understand how bad the system is.”

    Even their attempts to warn other Canadians about the drug they believe caused their son’s death have been thwarted. After Nancy submitted an adverse-reaction report in April 2012, she noticed a typo on her entry so she called the Vigilance Branch requesting a correction. She also asked for an updated copy. She was told she’d have to file an access to information request. Seven months later, anyone searching Cipralex on MedEffect would find 317 reports, including five “completed suicides,” 12 “suicide attempts” and many references to “suicidal ideation,” but not McCartney’s submission. When Maclean’s asked Health Canada why, Upton responded by email weeks later, saying the entry is in the database, providing a screen grab. Yet subsequent searches using the same terms failed to find it.

    “It’s a lot easier to access the system from the inside,” Upton explained. He’s right. And until it isn’t, Canadians shouldn’t believe that our drug-regulatory system is one of the “safest and most rigorous” in the world.

  • Health Canada responds to questions about hidden clinical trial data

    By Julia Belluz - Friday, November 2, 2012 at 12:24 PM - 0 Comments

    (Jeffrey Coolidge/Getty Images)

    In Canada, pharmaceuticals are one of the fastest-growing cost drivers in our health system. And we are gobbling up prescription drugs with increasing enthusiasm. Between 1997 and 2007, Canadians were second only to Americans when it came to increases in per capita drug spending.

    Yet the data we collect from clinical trials about the drugs we take remains largely hidden from view: it’s not available for examination by independent researchers, and the information about drugs that is published tends to be positive, an unrepresentative sliver of all that’s known. As the editor of the British Medical Journal and other doctors around the world have pointed out, this means patients, doctors and governments can’t make fully informed decisions about treatments.

    This is a problem that affects anyone who uses pharmaceuticals — or their loved ones who do. Because of this situation, jurisdictions around the world have been working to make the clinical trials process, the testing of drugs, more open and transparent.

    Yet Canada lags here. As Science-ish noted in an open letter to the Federal Health Minister Leona Aglukkaq, and subsequently, letters from researchers, the recent announcement about the government’s intention to create “a web-based list” of clinical trials for Canadian patients seems to reflect what was known about this issue over a decade ago, and ignores the evidence that’s been gathered since then.

    Continue…

  • Health agency warns of ‘death by hospital bed’

    By The Canadian Press - Monday, August 13, 2012 at 2:51 PM - 0 Comments

    OTTAWA—Health Canada is warning hospitals and other health-care facilities about the risk of entrapment of patients in hospital after three people died and several were injured.

    OTTAWA – Health Canada is warning hospitals and other health-care facilities about the risk of entrapment of patients in hospital after three people died and several were injured.

    In a notice to hospitals issued Monday, the health agency says 12 incidents have been reported of patients becoming trapped in hospital beds since 2009, including three deaths.

    Four similar deaths were reported between 2007 and 2009.

    The notice says unprotected side rails and unfitted mattresses are the main hazards for patients, while beds made prior to the year 2000 are identified as being particularly problematic.

    Eight out of the 12 cases of injuries and deaths have occurred in nursing homes or long-term care facilities, while three incidents happened in hospitals and one at home.

    Health Canada says in one incident, a patient became trapped in the opening between the split side rails of a Stryker Model FL14E1 long-term care electric bed, which is no longer manufactured but is still in use.

    The agency advises health-care facilities that still use beds made before 2000 to contact manufacturers for advice on reducing entrapment hazards, including using covers to fit over the gaps between rails and ensuring that replacement mattresses are the correct size for the bed frame.

  • A mighty wind

    By Aaron Wherry - Monday, July 30, 2012 at 11:43 AM - 0 Comments

    Leona Aglukkaq’s request for a Health Canada study of wind turbines wins support from another Conservative MP, this one in Britain.

    Andrew Percy says, “Many people living close to these giant wind farms report health impacts including depression, sleep disturbance and behaviour changes and it is important we have a proper study of these impacts. I live opposite a wind farm in Airmyn and whilst it hasn’t affected me, other people do report disturbances.

    “I have long believed that we need to set strict limits on how close these farms can be built to properties and last year sponsored a Bill in Parliament to set minimum distances. For the past two years I have also been demanding a cut in the subsidy for on-shore wind.

    “Given that the Canadian Government is listening to the concerns of residents living near to wind farms, it seems sensible to me that we should approach Health Canada to make this a joint study. I have written to Ministers asking them to do just that. ”

    Previous coverage of the wind farm debate herehereherehere and here.

  • Harper’s anti-drug strategy gets a little less compassionate

    By John Geddes - Wednesday, July 25, 2012 at 6:50 AM - 0 Comments

    For the next five years, the focus will be more on busting drug users than helping them

    Drug money

    Tara Walton/Toronto Star

    When Stephen Harper launched his high-profile National Anti-Drug Strategy in the fall of 2007, he took aim at critics who were already saying his new Conservative government was putting too much emphasis on more drug arrests and longer prison sentences, and not enough on helping addicts. “This approach will be tough on crime and compassionate for victims,” the Prime Minister said in a speech in Winnipeg announcing the policy. “If you’re addicted to drugs, we’ll help you, but if you deal drugs, we’ll punish you.”

    The blueprint Harper unveiled that day would bring more than $500 million in spending by a dozen federal departments and agencies under one umbrella. Spending was mapped out for five years, the period that ended this past spring. Now, a plan for the next five years of anti-drug programs, again worth more than half a billion dollars, has been drafted. Despite Harper’s early emphasis on balance, though, the planning and priorities report tabled with the federal Treasury Board for the next five years reveals deep cuts in Health Canada’s budget for drug treatment—but hefty increases in budgets for drug enforcement by police and prosecutors.

    The spending squeeze that’s likely to be most demoralizing for groups running street-level rehabilitation programs for addicts is the reduction of Health Canada’s Drug Treatment Funding Program to $80 million for the next five years, down from $122 million in the previous five years. In sharp contrast, the RCMP will see its five-year funding for investigating marijuana growers and clandestine drug labs rise to $113 million, up from $85 million in the previous five years. As well, support for the federal Office of the Director of Public Prosecutions will rise to $61 million for the coming five-year stretch, up from $43 million for the strategy’s first half-decade.

    Continue…

  • Laissez-faire food

    By Aaron Wherry - Tuesday, July 24, 2012 at 1:21 PM - 0 Comments

    Sarah Schmidt reviews the last few years of rejection at the Health department.

    Aglukkaq’s office confirmed this week that the recommendations have been rejected … Aglukkaq prematurely disbanded her much-touted expert panel on sodium in December 2010 … Aglukkaq immediately shot down the idea and defended the way companies label their food products … After sitting on the report for over a year, Aglukkaq finally announced she was rejecting the advice … Five years after unveiling a proposal to end consumer confusion over “whole wheat” claims on bread products, Health Canada confirmed earlier this year it has no plans to change the food-labelling rule.

  • ‘Just sit back and wait and see what the results are’

    By Aaron Wherry - Thursday, July 19, 2012 at 5:31 PM - 0 Comments

    Add Patricia Davidson to those Conservative MPs calling for a moratorium on wind turbines in Ontario.

    “We know that there’s a tremendous amount of concern in the community,” Davidson said. That’s why MPs in southwestern and eastern Ontario pushed Health Canada for a study, she said. “In the meantime, I think that it makes perfect sense for all of us to just sit back and wait and see what the results are.”

    Suncor Energy is proposing to build the Cedar Point Wind Power Project, which could see as many as 62 wind turbines placed in Plympton-Wyoming, Lambton Shores and Warwick Township as early as 2013. More turbines are proposed for other projects in Lambton Shores and neighbouring Middlesex and Huron county’s. “If all of these turbines go ahead and we find that there are health issues,” Davidson said, “then that’s really putting the horse before the cart. I think we need to have the results first.”

    See previous coverage here, here and here.

    Ontario’s chief medical officer reported on the available scientific evidence on wind turbines in 2010. Health Canada has extended the deadline for public submissions ahead of its study.

  • Worrying about windmills

    By Aaron Wherry - Monday, July 16, 2012 at 2:57 PM - 0 Comments

    Conservative MPs Bev Shipley, Larry Miller and Garry Schellenberger support a moratorium on wind turbine development until Health Canada’s study is completed.

    Speaking from his cottage at Grand Bend, Schellenberger said he and other members of the Conservative rural caucus took their constituents’ concerns about wind farms to Minister of Health Leona Aglukkaq. ”It’s a big issue all over Ontario, not just in Perth-Wellington,” he said “In Huron and Bruce they are very concerned and in eastern Ontario – it’s all over the place.”

    He recalled attending a meeting in Sebringville about a year ago and hearing presentations about the health effects on people and “about how it has ruined their lives.” ”We took it to the minister over the course of the year and we did request something be done by Health Canada — that a proper study be done so that everyone can be heard and we can work on scientific evidence.”

    “It’s not just a question-and-answer form. It (the study) will be quite involved and I look forward to that. My concern with this is that’s it’s done properly and that when the results come out that either side — there are two sides to this — that whatever the findings are the differences can be resolved.”

    See previously: All politics is local wind turbines and Wind turbines and the need for consultation and evidence

  • Wind turbines and the need for consultation and evidence

    By Aaron Wherry - Thursday, July 12, 2012 at 12:53 PM - 0 Comments

    I asked Megan Leslie for an NDP response to the general issue of wind turbines and the recent announcement of a Health Canada study. Here is what she wrote in reply.

    The NDP is very supportive of renewable energy technologies. However, as with any project, there needs to be true community consultation. There is tremendous insight and expertise at the community level, and we need to tap into this resource.

    As we have said with the oil sands, all energy sources in Canada should be developed in a way that is safe for Canadians and for our environment. This study is a good example of how proper scientific evidence, led by public research, can help people understands the impact of these systems. More of these studies should be conducted to better understand the impact of other sources that have raised public concern, like cellphone towers. The NDP supports the use of science and evidence in decision making, which is in stark contrast to the way Conservatives have been making their decisions lately.

    Speaking of evidence, it’s odd to see the Conservatives funding studies on green energy technology while at the same time they’re killing environmental assessments for fossil fuel projects. Why the double standard? While the health and environmental concerns of large wind turbines merit study, the huge problems of smog and the thousands of deaths directly attributed to air quality, mercury contamination, and climate change, all deserve immediate and decisive action, and this government has provided neither. And where are the long-promised studies of oil sands development on the First Nations downstream of the oil sands?

    When the PMO directly calls the group lobbying for this delay, I can’t help but think that this is a crass political move to undermine the development of renewables. I don’t remember the PMO calling anyone in Ft Chipewan about their health concerns living downstream, or any of my constituents with concerns about cell towers in their neighbourhoods.

    This last bit is reference to the Globe’s report this morning that the Prime Minister’s Office contacted Wind Concerns Ontario to let the group know the study was being pursued.

    Health Minister Leona Aglukkaq’s office explains that the minister requested the study after hearing from MPs—primarily from Ontario—that constituents had concerns about the health impacts of wind turbines. The department had apparently been working with the provinces and territories to establish voluntary guidelines for “set backs,” but that process concluded without firm decisions.

    The official notice to stakeholders is here. Relevant questions and answers are posted here and the members of research design team are listed here.

  • Caitlin Cronenberg’s pop-up photo exhibit exposes truths about MS

    By Anne Kingston - Friday, June 8, 2012 at 4:16 PM - 0 Comments

    The dream-like images were commissioned by a PR firm that represents Novartis Canada, makers of a controversial MS drug

    CNW Group/Novartis Pharmaceuticals Canada Inc.

    Caitlin Cronenberg is a young photographer who has made a name for herself chronicling fashion and celebrity—as well as the cinematic process of her filmmaker father, David Cronenberg. So a press release issued last week headlined “Caitlin Cronenberg Exposes the Reality of Young Women Living with MS” appeared to signal a bold—even brave–departure for her. Multiple sclerosis, or MS, is a chronic degenerative condition that can lead to paralysis, depression, and blindness. It’s a mysterious condition; progression varies radically; its cause is unknown. Nobody even knows how many Canadians have it: the much-repeated statistic of 50,000 to 75,000 people is out of date, an MS Society of Canada spokesperson told me months ago.

    It doesn’t lend to easy imagery. So I wondered: Is Cronenberg now delving into the dark, uncomfortable territory annexed so well by her dad?

    But the “reality” that Cronenberg’s one-night exhibit, DREAM/AWAKE, exposes is less about MS than about how a pharmaceutical giant can create buzz amid advertising restrictions—in this case, by linking a fashionable female photographer to a prescription drug targeted at young women. That’s whom multiple sclerosis strikes most—three times more frequently than men.

    Cronenberg was hired for the gig a few months ago by Weber Shandwick, the PR firm that represents Novartis Canada, a sub of the US $46-billion Swiss pharmaceutical giant Novartis AG. “They told me they came up with the idea for the installation with me in mind,” Cronenberg told me in a telephone interview. She was flattered.  She also has family friends afflicted with MS, she says. A former neighbour she’s fond of is now wheelchair-bound.

    Cronenberg was given “total artistic freedom” on the project, she says, although the client provided three women to be photographed, all of whom were diagnosed with MS in their 20s or 30s, when the condition often strikes. Rebecca Webster of Weber Shandwick explains the women were chosen after they were “nominated by their treating neurologists who felt strongly that this project was important to raise awareness about MS, especially among women.”

    The three had had success taking Novartis’s Gilenya, a $31,000-a-year oral MS pill approved by Health Canada in March 2011 (until then, MS drugs had to be injected). Gilenya isn’t explicitly mentioned in the press release. But as it happens, one of the women, Himani Ediriweera participated in Gilenya’s clinical trials and was quoted enthusing about the drug in a 2011 press release.

    CNW Group/Novartis Pharmaceuticals Canada Inc.

    Cronenberg says she based 12 photographs on the women’s stories. The resulting staged tableaux exude a dreamy, unworldly vibe that make no reference to illness—one woman appears to be in a childhood bedroom; another stands next to a red BMW and a toy sailboat; a third is in a shadowy room festooned with pages of paper. The press release describes the photographs in dramatic, yet upbeat terms: “The images demonstrate the feelings of loss—of body, family, opportunity or work–and how each woman has reclaimed her life through treatment and become a figure of inspiration for young women fighting the disease.”

    The exhibit of Cronenberg’s photographs was a one-night pop-up event on May 30, “World MS Day,” staged at a Toronto gallery that rents out to corporations wanting to imbue an event with arty patina (Loblaw Companies launched a new packaged food line there last year). Webster describes the affair as “invitation-only for media and influential people.”  Cronenberg donated the work to a silent auction with proceeds going to the MS Society of Canada. “Several thousands of dollars were raised,” says Webster, declining to be more specific.

    The show was marketed as bringing “awareness” to MS—and received media attention as a result, including Cronenberg being interviewed on the CBC. The line between “awareness” and “promotion,” however, is fragile, given Health Canada’s strict regulations governing direct-to-consumer advertising of prescription drugs. Regulations allow drug companies to use a brand name but not talk about what a drug does. Direct to consumer information—those public awareness ads on TV discussing a specific condition—has to be balanced and can’t use brand names.

    But social networking has created new grey areas. Cronenberg’s photographs themselves contain no branding, no mention of Gilenya or Novartis—though the exhibit and press release mentioned the company and there are now plentiful linkages between Cronenberg, the MS Society of Canada, Novartis and Gilenya exist online. (Health Canada is investigating the exhibit to see “if it was promotional in nature,” a spokeswoman told me.) Where the hopeful claim that “each woman has reclaimed her life though treatment” in art show PR fits into the rigid regulatory equation is new territory.

    What also doesn’t have to be mentioned in the press release for the exhibit—because the photographs are technically part of an art exhibit and not a commercial—is “side effects.” And in Gilenya’s case, 84 people died during its worldwide clinical trials, though some of those deaths were not directly linked to the drug. Instances of adverse effects are so high that neurologists must monitor people closely for six hours after the first dose. In February, 2012, Health Canada put Gilenya under review, though the drug still can be prescribed. Concerns were raised after 11 new deaths (a number that has since risen to 15) were linked to it (none were in Canada but there were more than 50 averse-effect reports).

    One woman with MS expresses conflicted feelings about the exhibit. “Positive images are a great thing,” says Chrystal Gomes, 46, who was diagnosed with MS when she was 28 and has never taken MS drugs. She “loved” Cronenberg’s pictures but dislikes the drug sponsorship—and the message: It makes me mad,” Gomes says.  It gives the impression that MS patients need drug treatment to reclaim their lives, which is so wrong.”

    Cronenberg knows the exhibit isn’t photo-journalism:  “I would never say this is a general statement about MS,” she says. “To look at it, you wouldn’t even think this is about MS. I wanted it to be uplifting.” She knows the subjects influenced content: “I was so lucky because women I was working with had happy endings to their stories; if someone had appeared in a wheelchair, I would have made her story different to make sure it was properly presented.”

    Of course, a company selling a MS drug won’t want to be associated with imagery referencing the harrowing truths of the condition. (For a more candid portrayal, see these self-portraits by Patricia Lay-Dorsey.)

    The exhibit shows how social networking is reframing the way we see illness and disease—and how drugs may be stealthily marketed. It’s also another reminder of how women remain the primary target of Big Pharma marketing, as discussed in the important book Push to Prescribe. While MS is too complicated a condition to summon the pretty, sanitized “pinkwashing” that now surrounds breast-cancer, the move to frame it as a “women’s” disease portends similar campaigns.

    The drug company-doctor network the exhibit reveals is also concerning. That neurologists are providing patients for a Pharma-sponsored “awareness” campaign that doesn’t add one whit of “awareness” should raise red flags—and a passel of questions.

    CNW Group/Novartis Pharmaceuticals Canada Inc.

     

  • Off-label drugs are off the charts in Canada

    By Kate Lunau - Tuesday, May 29, 2012 at 9:44 AM - 0 Comments

    One in 10 pills swallowed is for unapproved use, with little science to back it. No one is keeping track.

    Photograph by Andrew Tolson

    When Rachel Lavallee’s son Sam was born five years ago, she was determined to breastfeed, despite a low milk supply. She spoke to her doctor about domperidone—a drug prescribed to treat stomach ailments, that has been used for at least 30 years to help women boost milk production. “It just about doubled my milk supply,” says Lavallee, 32, a nurse in Halifax. When son Alex was born last August, she took it again. “For baby number two, it was the same,” she says.

    This March, Health Canada issued an advisory, stating the risk of abnormal heart rhythms or sudden death may be higher in patients taking higher doses of domperidone, or in those over age 60, based on two new studies. A letter from the Canadian Lactation Consultant Association noted the average age of patients in the studies was 72 and 79, respectively. “When I looked at the [studies] it was based on, it has nothing to do with new mothers,” says Joan Fisher, a lactation consultant in Ottawa. Lavallee, who takes three tablets four times a day, is unfazed. “Based on my age, health, and my reasons for taking it, I feel the benefits outweigh the risks.” After discussing it with her family doctor, she continues to take the drug. Countless other women are doing the same.

    When doctors prescribe domperidone to increase milk production, it’s an off-label use, meaning it hasn’t been approved by Health Canada. It’s not the only drug used this way. Quinine, an anti-malaria medication, has long been prescribed to treat nighttime leg cramps; antipsychotic drugs are frequently given to dampen some symptoms of dementia. At Apex Compounding Pharmacy in Toronto, pharmacist-owner Ara Papazian has raspberry-flavoured lollipops laced with ketamine, a powerful anaesthetic prescribed to those who suffer from chronic pain. “We make Viagra in a lozenge. As opposed to the guy taking a pill one hour before the act, he can pop this under his tongue and he’s good to go within 15 minutes.” Papazian sometimes recommends an anti-cancer drug, tamoxifen, in an ointment to help heal scars.

    Continue…

  • Health care cuts

    By Aaron Wherry - Tuesday, April 10, 2012 at 10:44 AM - 0 Comments

    About 840 jobs might be cut at Health Canada, while the National Aboriginal Health Organization’s funding has been eliminated.

    “We got a call last Wednesday and they told us that our funding of $4.4 million was cut, that what they were doing was protecting the monies that go to regions, to First Nations and Inuit – direct services was being protected and that funding for indirect services like ours was being cut,” said Simon Brascoupé, NAHO’s chief executive officer.

    The not-for-profit organization will close June 30. It has been running for 12 years. NAHO’s mandate was to work to advance the health of First Nations, Métis and Inuit people in Canada. It had separate branches to address the health needs of each group.

  • Assisted Human Reproduction Canada: the budget cut everyone missed

    By Anne Kingston - Monday, April 2, 2012 at 6:17 PM - 0 Comments

    The agency was largely useless but its shuttering curtails federal oversight of fertility treatments

    .ahrc-pac.gc.ca

    Of all the cuts made in last Thursday’s budget, the axing of Assisted Human Reproduction Canada was one of the least contentious—even though it leaves the country without official federal oversight of assisted reproduction and fertility treatments, an arena rife with health, legal and ethical imbroglios. Only last month, the RCMP launched its first investigation into potential breaches of this country’s murky fertility law, leading to a shutdown of an Ontario fertility-treatment consultant.

    Those who work in the field weren’t surprised by the AHRC’s demise: founded in 2006, the agency has been barren for years. Its original mandate was to enforce the Assisted Human Reproduction Act, legislation stemming from a 1989 Crown Commission that took 18 years of bickering to become operational. The act cut a wide swath: from prohibiting human cloning and transplantation of non-human and human life—the theme of Sarah Polley’s 2009 sci-fi flick Slice–to regulating the terms of third-party human reproduction by banning outright payment for surrogacy, donor eggs and sperm.

    As it turned out, that swath was too wide. In December 2010 a Supreme Court decision stemming from a Charter challenge launched by Quebec declared sections of the act unconstitutional (though it didn’t touch the sections which prohibit the payment of a surrogate mother or donor eggs or sperm), thereby denuding the AHRC of much of its authority.

    Continue…

  • What your wine label won’t tell you

    By Pamela Cuthbert - Wednesday, September 28, 2011 at 12:00 PM - 6 Comments

    Some worry an Ottawa-approved GM yeast for wine will destroy its ‘naturalness’

    What your wine label won’t tell you

    Photography by Colin O'Connor

    They are airborne, free for the taking—and lately, highly contentious. Wild yeasts, a traditional ingredient in making wine and leavened bread, were arguably the first micro-organisms to be domesticated, some 6,000 years ago. Now, they’ve got people locking horns. The bread and wine worlds are clashing over who goes native with the naturally occurring stuff and who opts for using common cultivated varieties. “Basically it’s sort of a culture war, like in the United States,” says Geoff Heinricks, Keint-he Winery and Vineyard’s winemaker, based in Ontario’s Prince Edward County: “Both sides can be ridiculously bombastic.”

    Wild or ambient yeasts inhabit wineries and vineyards, often carried by insects such as fruit flies, and introduce complexities of flavour and texture in the early stages of fermentation. They die when the wine reaches a low-alcohol level of about five per cent (wine is typically 12 to 14 per cent), then give way to the species Saccharomyces cerevisiae—it occurs naturally and is also the commercially produced variety—that finishes the process.

    The alternative, inoculating crushed grapes with commercially produced yeast, promises results of speed, expedition and predictability, or standardization. This practice took off with the demand for New World mainstream wines in the 1970s and is still the mainstay in these markets, although there’s an increasing fringe interest among major producers in making small-batch wines that are labelled “wild-yeast” vintages and generally come with a higher price tag. “Like a marketing thing, splashing it on the label,” says Heinricks.

    Continue…

  • A pinch of reality about salt

    By Alexandra Shimo - Thursday, September 15, 2011 at 11:15 AM - 8 Comments

    Health Canada’s war on salt has detractors who say low-sodium diets can be hazardous to your health

    A pinch of reality

    iStockPhoto

    The Canadian government is in an all-out war on salt. According to Health Canada, about half of us are consuming more than double the recommended daily dose, and it plans to rectify that by altering the food supply. The problem, say critics, is that the response could do more harm than good. There’s no question high-salt diets can affect blood pressure, but several studies suggest this outcome, generally speaking, is dwarfed by other health benefits. In fact, the government’s position, critics charge, is based on out-of-date data, and ignores the most recent studies. Worse, Ottawa’s salt offensive could cause serious health concerns, including heart disease, low birth rates, kidney disease, or an early death. “[Canada’s] limits are not based on science,” explains Michael Alderman, a physician and epidemiologist at New York’s Albert Einstein College of Medicine and editor of the American Journal of Hypertension. “Folks that eat the least amount of salt have the worst outcomes. They die.”

    The average Canadian consumes 3,400 mg—about 1½ teaspoons—of sodium every day. Health Canada advises an adult dosage of 1,500 mg a day, and a maximum of 2,300 mg. These are based on the “significant body of evidence linking high sodium intake to elevated blood pressure, which is the leading preventable risk factor for death worldwide,” reads the Health Canada website. “High blood pressure is the major cause of cardiovascular disease and a risk factor for stroke and kidney disease.” To achieve these targets, Health Canada is trying to raise consumer awareness on the dangers of salt, fund research, and change the food supply by lowering the amount of salt in everything from breads to cheeses and soups to sausages. If all goes according to plan, the average Canadian will be down to 2,300 mg of sodium a day by 2016.

    The targets, says professor Mary L’Abbé, chair of the department of nutritional sciences at the University of Toronto, are based on a number of studies, including one from the Cochrane Collaboration from 2006 that conclusively linked salt to high blood pressure. L’Abbé is the former chair of the Sodium Working Group, which, before it disbanded last December, set Ottawa’s sodium-reduction strategy. “Reducing sodium by 1,700 mg per day would result in an average drop in blood pressure of two millimetres of mercury,” she explains (millimetres of mercury, or mmHg, is the measure used to describe the force of the blood against arteries. Optimal blood pressure is below 120/80 mmHg). Although 1,700 mg is still above the recommended daily level, even modest changes can affect the incidence of stroke and heart disease. “Obviously, the higher your initial sodium intake, the greater your benefit,” says L’Abbé. “But even with a 1,100-mg reduction, you still get blood pressure reductions.”

    Continue…

  • ‘I think the controversy has created a good teaching moment’

    By Aaron Wherry - Thursday, July 28, 2011 at 3:17 PM - 29 Comments

    Elizabeth May explains, at length, her feelings about electromagnetic radiation.

    When I was first attacked and lambasted for expressing concern about various forms of pollution and human health, I was young and the attackers were brutal.  I was worried about things like Agent Orange.  Health Canada wasn’t.  I was concerned about lead in gas, but it was hard to get the government to act.  I worked to get certain pesticides banned, but they were “safe” right up to the day they were banned … There is no scientific consensus on EMF and health. But, it is equally not possible to make the claims many of Twitter have made today that Wi-Fi and cell phones are all proven “safe.”

    Jonathan Kay notes that one of Ms. May’s wifi-related tweets yesterday was sent from her BlackBerry. Relatedly, Mike Moffatt takes the Green Party to task for its position on smart meters.

  • In the air tonight

    By Aaron Wherry - Wednesday, July 27, 2011 at 4:56 PM - 33 Comments

    This afternoon, Elizabeth May took to Twitter to fret about the harmfulness of wifi. Some degree of mockery ensued. As to the central issue, Kate Heartfield posts a Citizen editorial from a year ago.

    The World Health Organization says there is no convincing scientific evidence that wireless networks cause any damage to human health. Yes, wireless devices emit electromagnetic radiation, as do other electronic devices we use in our homes and offices: computers, televisions, even baby monitors. The exposure to radiation from a mobile phone, which is generally much closer to the person using it than a wireless access point, is much higher than that from a wireless network.

    It’s certainly true that exposure to wifi networks has increased over the past few years, and that it might take time for any ill effects to show up in the research. So it makes sense for health agencies to keep monitoring the research and be prepared to change their minds, as is true for all science. The evidence from the research to date, though, is clear and reassuring. There is certainly no reason to start getting rid of wifi in schools and other places where children spend a lot of time.

    The WHO fact sheet on wireless networks is here. More recently, Health Canada posted the following video. Continue…

  • Will those genetically modified soy beans make you sick?

    By Julia Belluz - Monday, July 11, 2011 at 2:56 PM - 52 Comments

    Photo by Karen Eliot/Flickr

    The Statement: “To date, Health Canada has not identified health risks associated with GM foods that have been approved for sale in Canada.” (Stephane Shank, Health Canada spokesperson, 07/05/2011)

    Codex Alimentarius Commission—a group of the world’s food safety regulatory agencies—reached consensus last week on new guidelines that will make it easier for food makers to label products with genetically-modified ingredients. The new guidelines are voluntary, though, so don’t expect advertisements about GMOs on the box of your favourite breakfast cereal anytime soon. And part of the reason Canada has not moved to mandatory labeling of GM foods is because, as Stephane Shank put it, “To date, Health Canada has not identified health risks associated with GM foods.”

    So, is GM food really safe?

    We called Dr. Sylvain Charlebois, a researcher in food distribution and safety at the University of Guelph, to find out. He told Science-ish, “There is no scientific evidence out there that would suggest GM seeds or foods that contain GMOs have health risks to consumers.” Dr. Charlebois did add this note of caution: the key phrase in Shank’s statement was ‘to date.’ “GMOs have only been accessible or readily available to consumers since 1994, so that’s 17 years ago. That’s not a whole lot of time for us to fully appreciate the risks around GMOs.”

    Discourse around genetically modified organisms—defined by the WHO as “organisms in which the genetic material (DNA) has been altered in a way that does not occur naturally”—has been a political and scientific battlefield. As a 2009 Nature news feature pointed out, “No one gets into research on genetically modified (GM) crops looking for a quiet life. Those who develop such crops face the wrath of anti-biotech activists who vandalize field trials and send hate mail… [Those] who suggest that biotech crops might have harmful environmental effects are learning to expect attacks of a different kind. These strikes are launched from within the scientific community and can sometimes be emotional and personal…”

    There’s also the knee-jerk reaction by the public—often reflected in the media—that these food items are borderline ghoulish, unnatural, and therefore potentially harmful to human health. Just think about the coverage of the transgenic “Frankenfish” salmon. The fish was developed decades ago by AquaBounty Technologies to grow faster than naturally occurring salmon, and has been waiting for a final seal of approval from the Food and Drug Administration for years. (Just last week, House lawmakers in the U.S. voted to bar the regulatory body from okaying the Franken-salmon for mass consumption, though the bill still needs to pass through the Senate.)

    Despite the political battles and the public’s wariness about these foods, Dr. Douglas Powell, a professor in food safety at Kansas State University who sat on the Canadian Biotechnology Advisory Committee (CBAC) in the early 2000s, was even less cautious than Charlebois when talking about the potential of GMOs to harm to humans. “(The CBAC) reviewed everything that was out there and there was nothing to show GMOs present a risk to health.” In fact, Dr. Powell has since moved away from researching the subject because, he says, “I got tired of talking about hypothetical risks.”

    Science-ish is a joint project of Maclean’sThe Medical Post and the McMaster Health Forum. Julia Belluz is the associate editor at The Medical Post. Got a tip? Seen something that’s Science-ish? Message her at julia.belluz@medicalpost.rogers.com or on Twitter @juliaoftoronto

  • Should you be using a salt substitute?

    By Cathy Gulli - Friday, January 7, 2011 at 9:00 AM - 9 Comments

    Ironically, some no-salt salts might be a bad idea, health-wise

    Should you be using a salt substitute?

    The dangers of consuming too much salt has become an international health issue, with governments setting new intake targets | Photograph by Jessica Darmanin, Illustration by Taylor Shute

    The question seemed simple enough: “What does the test kitchen think about salt substitutes?” Diane Boeri of Worcester, Mass., had sent a letter to Cook’s Illustrated, the Boston-based magazine that employs chefs and scientists to develop foolproof recipes and compare products. Her request, which was published in the latest issue’s “Notes from Readers” section, was for help making sense of the ever-growing variety of salt alternatives occupying supermarket shelves.

    In reality, it’s a loaded question. Fanatics insist there is no substitute for salt—that the taste and texture and the way it changes food can’t be replicated. Health nuts argue that using no salt or an imitation substance is the best choice—and swear that quitting cold turkey isn’t so bad.

    Continue…

  • Women lash out—way, way out

    By Joanne Latimer - Tuesday, December 21, 2010 at 12:00 PM - 1 Comment

    For women who’d rather be caught without pants on than forget their mascara, there’s a new ‘miracle’ fix

    Women lash out—way, way out

    Carlo Allegri/Reuters

    Casting aside the sober insert outlining possible side effects—something about itching, and irreversible darkening of the iris—I open a bottle of Latisse, an eyelash-growing drug just approved by Health Canada. According to its manufacturer, Allergan (yes, the Botox people), results can be seen in eight weeks; by week 16, lashes should be fuller, longer, darker. The cost: about $150 a month, and the patience to keep up with a regimen of nightly applications.

    Vanity wins over fear and skepticism, and I dab some on my sparse lash line. No funny smell. No burning. No blindness. Is this the beginning of the end for mascara?

    Cosmetic companies don’t seem too worried. “Latisse is a drug that transforms and we don’t make that claim,” says Stéphanie Binette, Canadian marketing director for L’Oréal-owned Maybelline New York, which is prepping for the 40th anniversary rebranding of Great Lash mascara, a tube of which is sold somewhere on the planet every 1.7 seconds. “Mascara is used to achieve different looks and effects. One doesn’t replace the other.”

    Continue…

  • Not exactly an accurate reflection

    By John Geddes - Friday, December 3, 2010 at 9:40 AM - 134 Comments

    Critics slam the Tories’ new anti-drug campaign

    Not exactly an accurate reflection

    Government video of DrugsNot4Me.ca

    There’s no denying the federal government’s new anti-drug TV ad tells a disturbing story. A freshly scrubbed adolescent in her well-appointed bedroom looks like she might be about to relax with a couple of Justin Bieber tunes. Instead, an eerie soundtrack starts up. “One, two, kicked out of school,” sings a hollow, girlish voice straight out of a horror-movie trailer. “Three, four, snort some more.” Soon she’s trashing the room, then randomly snipping off some of her own hair, and finally scratching at the angry needle marks on her forearm. “Five, six, need my fix.” It’s a relief when the spooky carousel music stops and a calming adult narrator advises kids to check out Health Canada’s DrugsNot4Me website.

    The ad, which is called “Mirror,” was launched on Nov. 17 by Health Minister Leona Aglukkaq. Her department is spending $1.06 million to make the spot so ubiquitous on teen-oriented TV that two-thirds of 13- to 15-year-olds are expected to see it by next March. The Conservatives also hope it carries a message for their mothers and fathers. “To Canadian parents,” Aglukkaq said, “we’re on your side, and you have our support in helping your kids say no to drugs.” Few would argue with that goal, of course, but researchers and front-line doctors who work with teen addicts are critical of key elements of the strategy.

    Continue…

From Macleans