Big Data: Bad science on steroids?

By Julia Belluz - Friday, February 22, 2013 at 4:02 PM - 0 Comments

Jared Zimmerman / Flickr

In case you didn’t realize, we’re living in the era of big data. From sequencing the molecules of human life to divine our futures, to capturing fodder on Twitter to predict disease outbreaks, big data’s potential is massive. It’s the new black gold, after all, and it can cure cancer, transform business and government, foretell political outcomes, even deliver TV shows we didn’t know we wanted.

Or can it? Despite these big promises, the research community isn’t sold. Some say vast data collections—often user-generated and scraped from social media platforms or administrative databases—are not as prophetic or even accurate as they’ve been made out to be. Some big data practices are downright science-ish. Here’s why:

Low signal-noise ratio

Let’s start with genome sequencing, an example of micro level big data capture. A newly published commentary in the journal Nature argued that, for most common diseases, screening people’s genomes is excessive and ineffective. That’s because, so far, genetic differences have been poor predictors of most diseases in most people. For example, with obesity or type-2 diabetes, many folks who have a genetic variant don’t get the disease or condition, while others do. If we started screening everybody, we’d have too many false positives and negatives to make such an exercise worthwhile.

The commentary’s lead author, Dr. Muin Khoury of the Centers for Disease Control and Prevention in the U.S., told Science-ish that the problem with big data genomics is that it’s hard to tell the signal from the noise. In the past, researchers working with smaller data sets would have a relatively modest number of statistically significant associations that were the result of chance. “In the genome era, when people started looking at millions of variants in a data set, they lowered their signal-noise ratio.” In other words, the bigger the data, the more opportunity to find correlations—that may or may not actually tell us something real.

Nassim Taleb, the author of Antifragile, does a good job here of explaining why bogus statistical relationships may be more common in the big data era, pointing out the parallel challenges with observational studies in health research. “In observational studies, statistical relationships are examined on the researcher’s computer. In double-blind cohort experiments, however, information is extracted in a way that mimics real life. The former produces all manner of results that tend to be spurious more than eight times out of 10.”

Hypothesis-free science-ish

Big data also goes hand-in-hand with “hypothesis-free science,” which some say departs from scientific principles. Instead of starting with a hypothesis and working out which data you would need to test it, researchers cast around for associations in data sets that are already available. Dr. Helen Wallace (PhD), director of the genetic science public interest group GeneWatch, put it this way: “If you don’t have a good scientific hypothesis about what causes a disease, you’ll probably end up measuring the wrong data in the first place.”

Screening the genome of everyone at birth, for example, seeks out the genetic basis for disease but doesn’t account for things like environmental exposures or lifestyle factors, which may actually be important predictors of sickness. She likens this to forecasting the weather by only measuring the temperature with a thermometer. “You would miss out on other key weather predictors, like barometric pressure.”

Big quality?

There are also questions about the integrity of big data. A recent article on Google Flu Trends showed that the online tracker massively overestimated the year’s flu season. For Rumi Chunara, a researcher who works on the big data infectious disease surveillance project HealthMap, it comes down to the quality of the data. “Sometimes you can find relationships, things that come up that could be happenstance, and could be confounded by something you’re not paying attention to,” she said.

The Google Flu Trends misfire may have been caused by this year’s hysteria in the media around influenza. People read the headlines about the deadly flu season and hit the Internet for information. Google Flu Trends calculated those extra searches as reflecting actual flu sufferers, when they were actually a big media feedback loop.

Similarly, HealthMap does not capture every infectious disease around the world—only the ones that are reported in the news media. This limits tracking to events that are picked up by media outlets in the 12 languages HealthMap’s algorithms are designed to detect. So, even though researchers are constantly tweaking their algorithms to limit error, infectious disease trends can be more media construct than reality.

Still, Chunara made a key point: “You have issues with every kind of data set.” That’s certainly true when it comes to official flu-tracking mechanisms. She sees big data as an adjunct to other more traditional approaches, not something that will supplant them. “We’re not going to be able to match some gold standard but we need to think about what aspects these new data sets bring,” she said. “These methods provide information our traditional methods don’t.” And they’ll do it faster.

It’ll take time for the scientific community to recalibrate its methods for the big data era. For now, just be wary of bad science on steroids.

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

If juice cleanses don’t really work, why are we hooked?

By Julia De Laurentiis Johnson - Saturday, February 9, 2013 at 7:00 AM - 0 Comments

Photograph by Liam Mogan

On day two of her three-day juice cleanse, Lindsay Grange cracked open a kale, celery and cucumber cocktail that smelled like a salad and looked like a swamp. With a sigh, she chugged it back. “I went through a period of too much prepackaged food and not enough sleep. I wanted to kick-start healthy habits and lose some weight,” says the 32-year-old, on what attracted her to a juice-only detox. She’s not alone: the start of the year finds bloggers and reporters turning their detox diaries into articles, and juice cleanses are this year’s choice. Celebrities like Blake Lively and Gwyneth Paltrow have been photographed with designer bag in one hand and juice-cleanse bottle in the other. Salma Hayek’s company, Cooler Cleanse, delivers juice regimes across America.

Companies offering juice-only diets have been popping up across Canada, too. For about $50 a day, for three to seven days, businesses like Bava Juice in Calgary and the Juice Cleanse in Vancouver drop off bottles containing fruit, nut and vegetable juices on your doorstep, with promises to rest and detoxify the digestive system. Some, like Raw Raw in Burlington, Ont., and Total Cleanse in Toronto, claim they’ve had a 20 to 40 per cent jump in clients within the past 12 months. Continue…

How did Jenny McCarthy earn a platform at a cancer fundraiser?

By Julia Belluz - Friday, February 1, 2013 at 9:55 AM - 0 Comments

Update Feb. 1, 5:15p.m.:

The Ottawa Regional Council Foundation has announced that Jenny McCarthy has been dropped from their fundraiser. 

“To be honest, we didn’t expect this kind of response,” Linda Eagen, president and chief executive of the Ottawa Regional Cancer Foundation told the Ottawa Citizen. “When we started to get that (negative) feedback where people were talking about anything but cancer, we just decided to move away from that.”

McCarthy tweeted the change of plans on her Twitter account: “So so sorry Ottawa! I had to pull out of event because of my new show taping conflict but will be back in a few months to make up for it!”

Science-ish blogger Julia Belluz wrote this column before the decision was announced: 

They say all publicity is good publicity, which can be the only way to explain why anti-vaccine campaigner Jenny McCarthy has been invited to appear at an Ottawa breast-cancer fundraiser next month.

McCarthy will be a guest fitness instructor at the Ottawa Regional Cancer Foundation’s March 2 “Bust A Move” event, which boasts Laureen Harper and an oncologist on its leadership committee. Inviting an anti-vaxxer to a health fundraiser is like getting Lance Armstrong to keynote a conference on honest sportsmanship. It’s just science-ish.

McCarthy is, after all, a pseudoscience peddler, credited with helping to bring back such vaccine-preventable diseases as measles and whooping cough. On the media rounds she has explained how vaccines gave her son Evan autism, which she cured with a special diet and supplements.  She also promotes other autism therapies, like the hyperbaric oxygen chamber.

Sadly, there is no cure for autism. The link between vaccine and autism is not controversial within the scientific community because it’s been discredited. Read all about it here. In sum: The study on which the vaccine-autism theory is based involved 12 children and no control group. It has been retracted and revealed to be a work of data manipulation. Of course, Andrew Wakefield—who authored the report and lost his medical licence for misconduct—co-wrote a book with McCarthy, titled Callous Disregard.

Here’s how event chair Bernice Rachkowski explained the committee’s choice to the Ottawa Citizen: ”She’s funny, she’s very much a people person, she’s vivacious and full of life.” Plus, Rachkowski added, “she also appeals to our target demographic because we want to engage younger women in being aware of breast cancer, how to prevent it and to be aware of all the help that is available if they, their aunt or mom are going through it.”

In response, one of Canada’s leading infectious disease experts, Dr. Noni MacDonald, told Science-ish, “Jenny McCarthy is likely all the things this woman is saying, but she also disseminates misinformation that may be harmful to children.”

Since the news of McCarthy’s Ottawa appearance, a #DropJenny hashtag has spawned on Twitter, and local skeptics have lashed out. Dr. Joe Schwarcz (PhD), director of McGill University’s office for science and society, told Science-ish, “If an anti-vaccine (promoter) is what is needed to attract young women, I’m worried.” It seems the only link McCarthy has with health research is that she likes to routinely deny it. 

Schwarcz questioned if a credible Ottawa foundation is doing public health a disservice by giving McCarthy a platform. Dr. MacDonald asked if McCarthy will be paid with funds that were raised for regional cancer services. “Who would want to donate to an organization that chooses to pay someone well known for spreading false and dangerous information?”

Science-ish also wonders what the event says about the state of public-health discourse in Canada. Why is McCarthy a go-to health promoter? She actively works against science, and the best-available research evidence contradicts her messages. It’s not clear what drives her work in health, other than the fact she makes money selling lies.

Science-ish tried but was unable to contact Jenny McCarthy, Dr. Susan Dent, medical expert on the Bust A Move board, and event chair Bernice Rachkowsk. The communications co-ordinator and CEO at the Ottawa Regional Cancer Foundation also did not reply. 

In an effort to better understand how McCarthy became the celebrity face of breast health in Ottawa, here are questions Science-ish hopes the charity will answer. Science-ish will happily update this story when they do:

1. Were you aware of McCarthy’s anti-vaccine views when you chose her for the Bust A Move event?
2. Are you concerned about the public health implications of this choice?
3. Do you see a conflict between McCarthy’s health messages and your work for health promotion?
4. Do you really think McCarthy was the best choice to speak on health?
5. How much is McCarthy being paid to appear at the event?
6. Will those fees come from money raised for breast-cancer services?

Science-ish is a joint project of Maclean’s, the Medical Post and the McMaster Health Forum. Julia Belluz is the senior 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

Are antiviral tissues worth the extra cost?

By Ryan Mallough - Monday, January 28, 2013 at 2:00 PM - 0 Comments

Flu season is a miserable time of dizzying nausea and hacking coughs for millions across North America. But for some companies, it’s also an opportune time for sales.

Kimberly-Clark, the maker of Kleenex brand tissues, has seen a net jump in its stock price in nine of the past 12 flu seasons (October-March), and is on pace to do it again this year. Its stock sits at $86.33 per share, up from $85.99 in October with peak flu season just around the corner.

Kleenex controls roughly 45 per cent of the approximately $1.5-billion tissue market, but saw its share slip last year as store brands made small gains. Recently, Kleenex has made a marketing push for what it calls its “sneeze shield” tissues, which are coated to prevent mucus from getting to the hands, and its antiviral tissues. These anti-flu tissues don’t come cheap. Sneeze shield tissues cost $3.99 for a box of 120. The antiviral tissues are $4.29 for a box of 68, or an incredible 12 times the cost of a run-of-the-mill box of Royale tissues at $0.69 for a box of 132. Continue…

Forget Weight Watchers: Twitter is a 24-7 diet support group

By Rosemary Counter - Monday, January 21, 2013 at 3:00 PM - 0 Comments

The social-media age of oversharing can come in handy when trying to shame yourself into eating better. (Photo by Reena Newman)

If you’ve been lucky enough never to find yourself at a Weight Watchers meeting, it goes something like this: a dozen dieters, mostly women, sit in a circle. In turn, but only if they want to, they share their weekly progress. “I lost 0.4 lb.,” someone might say. The rest of the room claps.

To encourage an appearance the next week, peppy leaders reiterate one staple statistic of the 50-year-old program: people who attend meetings regularly lose three times the weight as those who do not. Nonetheless, just two years after its last relaunch, Weight Watchers is revamping again (with its online 360° program) in an effort to keep up with the times.

Some dieters are already a tweet ahead. “I love a good meeting, but there wasn’t always a meeting when I needed it,” says 43-year-old Rebecca Regnier, a television reporter from Ohio. For her—and 58 per cent of Canadians who Weight Watchers says tried to lose weight in the last year—Twitter is always there. “When it’s 2 a.m. and I’m fighting a snack craving, it’s not 2 a.m. in Australia. I have friends there to talk me out of it.”

To her ever-expanding network, Regnier’s tweets include healthy humblebrags (“An apple handled some pre-lunch cravings for me today. Yay apple!”), support for her followers (“Don’t quit! Restart”), and admissions of gluttony (“I had a candy-bar-in-the-car moment”).

Despite periodic transgressions, all documented on @LaughItOff to almost 9,000 followers, Regnier lost 20 lb. How she did it—in short, choose any diet that works for you, follow experts in the field, connect with followers for support—became the ebook Your Twitter Diet, one of many that marries dieting with social-media oversharing.

Web options include Tweet What You Eat and Tweet Your Weight. GQ correspondent Drew Magary, down 60 lb., tweets his weight every morning in what he calls the “public humiliation diet.” With just the push of a button, an endless series of websites (Lose It, FitDay, SparkPeople) and apps (My Diet Coach, Thin Cam, the Eatery) can broadcast every bite into cyberspace.

Doing so isn’t always as easy as it seems. Meegan Dowe, a 33-year-old education coordinator from Halifax, who used to blog about her weight struggles anonymously, used the MyFitnessPal app to track her 90-lb. loss. “It tweets both the food I eat and the calories I burn,” she explains.

Though she hates to admit it, Dowe doesn’t think she could have lost the weight without Twitter. “It gave me a community I didn’t have; people at a similar weight as me and with the same frustrations,” she says. While people are almost always positive, sometimes they’re nasty. “I’ve heard things like, ‘You only burned 300 calories in 60 minutes? I could do it in 20.’ ”

Unlike Weight Watchers, Twitter is far from a private place. For those who thrive on aggressive competition, like GQ’s Magary, this might be “its own incentive anyway,” he wrote.

Others, not so much, says Weight Watchers’ chief scientist, Karen Miller-Kovach. “Social dieting is probably great for some and terrible for others.” The research is mixed, she says. It’s generally accepted that obesity is socially contagious, and that more and better support is associated with long-term weight loss. If social media are part of your support system, reported the Archives of Internal Medicine in December, then they can certainly help your progress. But they can’t be your only trick. “You’re not going to tweet yourself to thinness, but if you’re following a program and also tweeting about it, you may see more success,” says Miller-Kovach.

If a public weigh-in feels akin to modern torture, the Twitter diet could be detrimental. “It can reinforce shame. It can be embarrassing, humiliating and not at all helpful,” she says.

Regnier admits to feeling the shame “just a little bit.” For binge eaters like her, food sessions are often solitary and shameful, and a midnight Twitter confession forces an accountability she might otherwise not have. “But seriously,” she asks, “if you’re not willing to share with someone what you’re eating, then why are you eating it?”

What is known—and not known—about your flu medication

By Julia Belluz - Thursday, January 17, 2013 at 11:20 AM - 0 Comments

Sometimes, we selectively ignore information. We seek data that confirms our beliefs and biases, and brush off evidence that conflicts with our thinking.

Sometimes, though, it’s not OK to ignore evidence. Especially when it comes to public health. So Science-ish was astonished when the Public Health Agency of Canada announced plans to take “exceptional action” and release a supply of the influenza drug Tamiflu from the emergency national stockpile to “ensure Tamiflu remains available to those Canadians who need it.”

If Tamiflu, also known by its drug name oseltamivir, had meaty evidence behind it, the news would a boon. We’d encourage Canadians to access an effective medicine during flu season. If the drug did what the public health agency suggests— reduce the chances of getting the influenza and minimize the harms associated with the flu in vulnerable elderly folks and kids—the actions would be comforting.

But that’s not the case. The release demonstrated that the guardians of Canadian public health, and sometimes those who report on it, selectively ignore key information.

Allow Science-ish to explain.

When Tamiflu was approved for the treatment of influenza in the late-1990s it was considered an effective drug for shortening the duration of the influenza, minimizing person-to-person spread, and reducing complications such as pneumonia and even hospitalizations. This belief was based on early studies, all funded and carried out by the drug-maker Roche. The antiviral became one of the World Health Organization’s “essential medicines” and governments around the world began to stockpile it to the tune of $6.9 billion worldwide (2009 value). Continue…

Global disease: The top risk factors

By Amanda Shendruk - Saturday, December 15, 2012 at 8:43 AM - 0 Comments

The well-respected medical journal the Lancet published the world’s largest ever systematic study of global disease. The extremely extensive report contains a wealth of data, and the Lancet’s editor-in-chief  describes it as “a critical contribution to our understanding of present and future health priorities for countries and the global community.”

Within the study, there is an extensive and fascinating section on mortality risks and causes. We all know that the world will soon end so the report won’t be relevant for long, but until then, the below list ranks the top 15 global risk factors and their change in rank since 1990.

For a more detailed look at risks closer to home, the graphic below ranks the top fifteen risk factors for high-income North America.

2012: Outrageous attacks on science

By Julia Belluz - Friday, December 14, 2012 at 10:48 AM - 0 Comments

Slaven Vlasic/Getty

The year 2012 brought with it many opportunities for wielding a big, debunking stick and pointing it towards outrageous attacks on science. From the Science-ish archives, to be read with a festive beverage, here are the worst offenders from 2012:

1. DR. OZ, FAITH HEALER
Though he may have started out as one of America’s most-trusted MDs after earning a seal of approval from none other than Oprah Winfrey, the medical community has long known that Dr. Mehmet Oz can be a font of pseudoscience. This year, when he was in Toronto to give a motivational lecture about the “biology of blubber,” I had a chance to sit-down with Oz and grill him about his use of medical evidence. In particular, when asked about his promotion of raspberry ketones for weight loss—a dubious supplement—he said it was “an example of where I’m trying to give you hope.” Needless to say, he didn’t pass the evidence test. I’m pretty sure I was the only reporter in the room he didn’t hug that day.
Related link: Dr. Oz, faith healer

Continue…

Which vitamins and supplements actually work?

By Julia Belluz - Thursday, December 6, 2012 at 12:02 PM - 0 Comments

Jon Feingersh/Blend Images/Getty

There’s a tendency to divide the world of pills in two: evil pharmaceuticals and nice supplements. When we’re looking at the outrageous claims on the labels of supplements—that they’ll help us lose weight, clear-up acne, live long lives—we somehow forgot that the natural-health business is a business like any other, and that in Canada, while there are loose regulations around these products, they are not necessarily safe or effective.

Unlike pharmaceuticals—which admittedly have their own evidence problems—”natural” pills don’t undergo rigorous testing before they reach the market. So some of the claims about them are simply lies or not based in good science. As Dr. Edzard Ernst, one of the world’s foremost experts on the evidence for alternative complementary medicine, told Science-ish: “It is a myth to assume that the supplement industry behaves any differently from any other industry. It is about making money, and all too often people are less than responsible in the pursuit of this aim.”

The good news is that there is strong evidence to either back or refute some common notions about supplements. Science-ish sifted through the research to identify indications for capsules that have compelling science behind them. Here’s the Science-ish guide to supplements:

Antioxidants for preventative health
Don’t mean to be alarmist here but the evidence suggests antioxidant supplements (beta-carotene, vitamin A, vitamin C, vitamin E, and selenium) may actually kill you quicker.

Vitamin C for colds
This is a myth. As Science-ish has explained in the past, this regularly updated Cochrane review on vitamin C and the common cold shows that popping these pills every day does nothing to prevent colds and only maybe shortens their duration.

Vitamin D for a range of indications
From combating chronic pain to staving off cancer, this celebrated supplement seems to be recommended for everything. Unfortunately, the evidence for most vitamin D-related claims is weak. It doesn’t help reduce the risk of a range of cancers. There’s little evidence that these pills can alleviate chronic pain. As well, no link has been found between vitamin D and reductions in blood pressure, improved cardiovascular outcomes, and the prevention of fractures in older women. People whom vitamin D can help: those who have tested positive for a deficiency.

Evening primrose oil for a range of indications
In a word: useless. Read here about uses for menopausal symptoms, here about eczema, and here about premenstrual syndrome.

Glucosamine for osteoarthritis
According to high-quality studies, these supplements appear to help manage pain and improve physical function in people suffering with this joint disorder.

Melatonin for jet lag
Melatonin supplements are the closest thing we have to a cure for jet lag. As a 2009 systematic review pointed out, “Melatonin is remarkably effective in preventing or reducing jet lag, and occasional short-term use appears to be safe.” What’s more, melatonin may also be effective for treating a number of sleeping problems, as well as cluster headaches.

Probiotics for gut health
For some very specific indications—managing diarrhea in hospital settings or antibiotic-induced diarrhea—probiotics seem to be helpful. But despite their popularity for improving gut health, the jury is still out.

St. John’s wort for depression
The use of this stuff to manage depression is actually backed by strong evidence. A synthesis of 29 studies in over 5,000 patients from several countries found that those who took the plant extract in the trials “were superior to placebo, similarly effective as standard antidepressants, and had fewer side effects than standard antidepressants.”

Weight loss supplements
Lies, damned lies. Raspberry ketones, green coffee beans: don’t waste your money! If there was a tablet that could help with weight loss, we would not be in the midst of an obesity epidemic. In fact, Science-ish has yet to come across claims about a weight-loss supplement that are backed by good evidence. As a general rule, when a study about one of these “fat busters” suggests it’s effective, that’s probably because the experiment was poorly designed or it was done in animals or cells but not in people.

Your supplement of choice isn’t listed here?
Check out this user-friendly, science-based website for more information about a range of supplements.

Science-ish is a joint project of Maclean’s, the 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

Canada’s first class-action lawsuit involving birth defects allegedly caused by anti-depressents gets green light

By Anne Kingston - Monday, December 3, 2012 at 4:38 PM - 0 Comments

A Supreme Court of British Columbia decision has paved way for Canada’s first national class action lawsuit against the manufacturer of an antidepressant drug alleged to have caused birth defects in children born to women who took it during pregnancy.

In the ruling dated Dec. 3, 2012, Faith Gibson of Surrey, B.C. was appointed “representative plaintiff” on behalf of a class defined as “any person in Canada, born with cardiovascular defects, to women who ingested Paxil while pregnant, and the mothers of those persons.”

In December 2002, Gibson was prescribed Paxil, a selective serotonin re-uptake inhibitor (SSRI) manufactured by GlaxoSmithKline Inc. that was approved for use in Canada in 1993. She took it throughout her pregnancy; on Sept. 13, 2004, her daughter, Meah Bartram was born with a ventricular septal defect, more commonly known as a “hole in the heart.”

Lawyer David Rosenberg, of Vancouver’s Rosenberg & Rosenberg will argue that GlaxoSmithKline knew or ought to have known of the risks and failed to provide adequate and timely warning to doctors and the public. (In 2005, Health Canada sent out a warning in agreement with GlaxoSmithKline that advised infants exposed to Paxil in the first trimester had a higher risk of congenital malformations, specifically cardiovascular defects.)

Next up, says Rosenberg, is a “common issues trial” in which a judge decides for the entire class certain common issues, such as “Did Paxil increase likelihood of birth defects?” and “Did GlaxoSmithKline fail to adequately warn Health Canada of the risks.”

GlaxoSmithKline Inc. has 30 days to appeal the decision.

Read the decision here:

The 13 biggest health and science questions facing the nation

By Julia Belluz - Friday, November 30, 2012 at 10:52 AM - 0 Comments

From climate change and fracking, to the role of the federal government in health care and a national independent science advisor: What do the Federal Health Minister and health critics of our major political parties think about the biggest health and science questions facing the nation?

Science-ish gathered questions from leading Canadian scientists, health researchers and health professionals, and put them to the Federal Health Minister Leona Aglukkaq, the Federal NDP Health Critic Libby Davies* and Federal Liberal Health Critic Hedy Fry. Read their condensed replies below and unedited responses here:

Continue…

Uncut replies from the Science-ish questionnaire

By Julia Belluz - Friday, November 30, 2012 at 10:50 AM - 0 Comments

Replies from the office of the Hon. Leona Aglukkaq, Federal Minister of Health

1. In your opinion, what is the role of the federal government in health care?

Our Government has a clear and strong commitment to health care.  We actively support a publicly funded, universally accessible system that respects the principles of the Canada Health Act. Federal funding for health care has reached historic levels.  With Budget 2012, we have put the Canada Health Transfer on a sustainable long-term growth track, reaching at least $40 billion by 2020 21. This will provide provinces and territories with the certainty and flexibility they need to address current priorities and to plan for the future. We also work with our partners to support health care innovation, with annual investments of over $1 billion in research and system improvement.  And we play a direct role in promoting healthy lifestyles and regulating health and consumer products to reduce health risks. These federal actions and investments in health care are helping to keep Canada’s health care system strong so that Canadians can get the care they need, when they need it.

Continue…

The politics of CCSVI research in Canada

By Anne Kingston - Friday, November 23, 2012 at 4:51 PM - 0 Comments

On Thursday the Senate Social Affairs, Science and Technology Committee was scheduled to go clause-by-clause through Bill S-204,  a National Strategy for Chronic Cerebral Venous Insufficiency (CCSVI), before voting on it. The bill, sponsored by Liberal Senator Jane Cordy, called for accelerated pan-Canadian CCSVI clinical trials, a registry to track patients who went out of country for treatment, and assured medical aftercare in Canada. But there was no cause-by-clause reading. Instead, in a surprise move, the Conservative majority silenced debate and six-to-five voted down the bill.  No surprise there.  Amid much politicking, Bill S-204′s twin, Bill C-280, a private member’s bill proposed by Liberal MP Kirsty Duncan was quashed by six votes last February.

Of course, the chamber of “sober second thought” is supposed to exist above petty partisan concerns–and Santa really does exist. But the details of this particular Senate committee, which heard from vascular specialist Paolo  Zamboni, who pioneered the CCSVI hypothesis, makes clear just how skewed the process can be. Earlier this month, Conservative senators unanimously refused to hear testimony from Canadians with MS, which shocked Cordy. “This is a patient-based system,” she says. “Why would the government silence the voices of the Canadians the committee was supposed to be helping?” (Patient testimony was invited when Saskatchewan was deciding whether to fund CCSVI clinical trials now taking place in Albany, NY.) Instead, the committee received written submissions from MS patients, many who’d had CCSVI treatment, some of whom had been denied medical aftercare in Canada.

“Your committee also shares the concern expressed by proponents of the bill that, in the early stages, some patients were refused medical treatment after having experienced complications resulting from venoplasty performed in other countries. However, it should be noted that provincial health authorities and the colleges of medicine took quick action to ensure that no Canadians would be denied medical treatment.”

According to transcripts of the proceedings, Liberal Senator Art Eggleton was quick to object, noting committee witnesses told “numerous stories” of people who badly needed medical treatment and were not getting it: “Because they had gone overseas to get the procedure, they were not finding it very easy, if at all possible, to get follow‑up medical treatment here. Some of them ended up with some complications or just needed some follow‑up advice, but were being turned away.  In fact, we heard that one person died as a result of this. Another person we heard was told to go back to Poland rather than being treated by a medical specialist here.”  He added: “I am not aware of any evidence that came before this committee that indicated any action was taken. We certainly heard from medical professionals and professors that they thought that it was abhorrent that these MS patients who had gone through the procedure were not getting proper medical treatment.”

The concluding statement that “the best path forward should be determined by science and medicine, not by Parliament,” (which dovetails nicely with the Harper government’s increasing decentralization of health care), also met with opposition from the Liberals. Senator Larry Campbell called it  ”completely hypocritical”–and incorrect: “Parliament deals with health matters all of the time,” he said. “We deal with drugs and we deal with issues involving health, even though it is a provincial responsibility.  As far as this last paragraph is concerned, it would be nice if the government actually did rely on science for decision making, which we know is not true.” His coup de grâce: ”If this in fact is true, we should not have a Ministry of Health.”

The committee’s summary also suggest a willful blindness to the state of CCSVI research and monitoring in this country. That’s reflected in its statement that the interests of  Canadians with MS are best served by “continued efforts on the part of the Government through the Canadian Institutes of Health Research Scientific Working Group and the Public Health Agency of Canada’s Canadian Multiple Sclerosis Monitoring System.” Anyone following CCSVI will know those efforts are all show, no action. The government proposed a monitoring system to track MS patients in early 2011 to be run by the Canadian Network of MS Clinics, the MS Society of Canada and the Canadian Institute for Health Information. This summer,  a government spokesperson told Maclean’s it would be up and running in 2012. That’s a pipe dream. The  ”Canadian Multiple Sclerosis Monitoring System” on the Public Health Agency of Canada website hasn’t been updated since Mar. 23, 2011. “It’s a work in progress,” says neurologist Anthony Traboulsee, the contact person for the Canadian Network of MS Clinics in an interview today with Maclean’s. And CIHR’s Scientific Expert Working Group, criticized for not having any actual CCSVI experts on it, isn’t even going to be around: it’s about to be shut down, according to Traboulsee who sat on the panel.

In a trifecta revealing of the tight network now adjudicating Canadian CCSVI research, Traboulsee,  who’s also affiliated with the University of British Columbia Hospital MS Clinic,  is the  principal investigator overseeing Canadian phase I/phase II  clinical trials scheduled to take place in four centres in three provinces. They were slated to commence Nov. 1 but that has been pushed back,  Traboulsee says, due to procedural hurdles to overcome and additional ethic board approvals  to be be passed. (That’s not counting  the Quebec City and Winnipeg centres which have yet to pass ethical review boards, which could take months.) Traboulsee is “hopeful” patient enrollment will begin in Jan. 2013.

Kirsty Duncan, who blasted the government for refusing to hear from MS patients, is skeptical any progress is being made. “It’s all smoke and mirrors,” she told Maclean’s yesterday. It’s now more than three years since  Zamboni’s theory  made headlines, Duncan notes. And three years of resistance to a procedure covered by provincial health plans for people with venous malformation who have not  been diagnosed with MS.  ”We are no further along,” Duncan says. “We have announcements,  that is it. Meanwhile, people’s lives are at stake.”  She questions why the bill even made it to  the Senate, given the deep-rooted opposition to it.  ”Was that just for show too?” she asks. Whatever the intention, a show was definitely had. Just don’t believe the Senate committee’s own review of its performance.

Canada’s drug problems

By Julia Belluz - Tuesday, November 20, 2012 at 10:37 PM - 0 Comments

(Jeffrey Coolidge/Getty Images)

Blame it on the law. That’s what Canada’s Health Minister Leona Aglukkaq did when she announced that she could not halt the approval of the generic version of OxyContin, a routinely abused and sometimes lethal painkiller. The medical community and politicians responded with a cri de coeur of regret and disappointment. Rightly so; opioid abuse is one of Canada’s most pressing drug problems. But it’s not our only drug problem, and probably not even our deadliest.

Science-ish contacted leading researchers across the country to get their take on the minister’s announcement, and the other drug-related issues that threaten Canadian public health.

1. Opioid addiction: A health systems issue.

As Drs. Irfan Dhalla and David Juurlink point out in this Ottawa Citizen commentary, “By some estimates, prescription drug overdoses have killed 100,000 North Americans over the past 20 years,” and part of the death toll can be attributed to the misuse and abuse prescription painkillers. (Just look at the graphs in this article.) These physician-researchers have been leading voices on the need for stricter regulation of these highly addictive pharmaceuticals, and when Science-ish contacted them about the news, they both expressed disappointment. But they noted that while it’s true the law may have prohibited the feds from rejecting the application of generic OxyContin, blocking generics is only a small part of the solution.

“In her letter, (the minister) implies that the drug is being used off-label, being prescribed in a high dose,” explained Dr. Dhalla, “but the label doesn’t limit the dose, and doesn’t say that OxyContin should only be prescribed for specific pain conditions. In fact, I think most observers would say this problem has arisen in the context of OxyContin being prescribed in accordance with its label.”

There’s actually insufficient evidence for the use of opioids beyond the acute and cancer-related pain for which they were originally intended, and Dr. Dhalla has done a good job of outlining how marketing filled the evidence void and boosted prescribing of the drug. Stricter labelling—so OxyContin only be prescribed for severe pain, and for a limited period of time, in accordance with the evidence from clinical trials—would fall within federal jurisdiction.

Another way the feds could ramp up efforts to address the prescription drug problem would be through calling on the provinces for a pan-Canadian approach to systems that monitor prescribing practices.

UBC pharmaceutical policy expert Steve Morgan explained, “In B.C., every single prescription that’s dispensed goes into our PharmaNet system, which tracks prescriptions drugs used by patients, information about prescribers, and allows for active monitoring.” This real-time database even flags worrisome practices or drug interactions. But this type of IT infrastructure is not in place in every province.

“If I were (a provincial health minister),” said Morgan, “I might tell the feds: ‘You have said the solution to this problem is monitoring and local regulation of practice, so why doesn’t the federal government then help pay for PharmaNet systems across the country?” Of course, all this requires more co-ordination between the federal and provincial players on the health file, and more leadership on the part of Ottawa—another problem entirely.

2. Health Canada’s transparency problem.

“No one has any idea what’s happening behind the walls (at Health Canada),” said Dr. Juurlink, a physician and researcher at the Sunnybrook Health Sciences Centre. “There are elements of the U.S. and European (drug regulatory) processes that are unclear but no one holds a candle to Health Canada when it comes to the lack of transparency and how byzantine the whole process is.”

One of the well-documented issues is the lack of information doctors, independent researchers and patients have access to about the drugs on the market here. As it stands, the Canadian public and health professionals don’t have a true understanding of the risks and benefits associated with the drugs they are prescribing and using.

For example, drug regulatory expert Dr. Joel Lexchin explained that at the very least, a physician might want to know whether the people in a drug trial for a treatment he is considering were similar enough to his patient. As well, some other minimum details for evidence-based prescribing, such as how long the trial was run, whether the results were statistically significant, whether the drug was compared to a placebo or another drug, and how many people withdrew from the trial. In a forthcoming study, he looked at every drug decision Health Canada released between 2005 and 2012, and found that information was lacking on all of these questions.

For this reason, researchers have been calling on Health Canada to not only provide more information about drugs that hit the market, but even about drugs and their uses that are rejected. This is key because doctors sometimes prescribe “off label”—meaning they write prescriptions for drugs outside of regulated uses—and there could be evidence that suggests they shouldn’t be doing so, but they have no way of accessing that information.

3. Clinical trials gone missing?

As Science-ish has noted in recent weeks, Canada lags behind almost every developed country when it comes to mandating that all clinical trials in humans be registered. (See this open letter to the Federal Health Minister, subsequent letters from researchers, and this interview with Health Canada.) Trial registry is a way of keeping tabs of what studies are being done, so evidence doesn’t go missing and trial endpoints aren’t changed to make results look more favourable. Without this kind of oversight, Canada is contributing to the perversion of the global evidence base. The Standing Senate Committee on Social Affairs, Science and Technology recently recommended the Canadian government take immediate action to address this issue. Science-ish remains hopeful that action will be taken.

4. The failure of post-marketing surveillance.

When a drug is approved in Canada, it enters the marketplace, and said Dr. Juurlink, “This amounts to a mass experiment on the population.” That’s because the people who are enrolled in clinical trials are often different from the patients who are taking the drugs. As well, sometimes the design and duration of trials do not resemble the way drugs are used in real life. So the safety and efficacy of experiments is not always reflected in the real world, and that’s why we need what’s called post-marketing surveillance—or doing follow-up studies and tracking problems with drugs after they reach pharmacy shelves. While pharmaceutical companies in Canada are required by law to report safety information that comes to their attention, the custodians of Canadian health care—doctors and front-line health professionals—are not.

Dr. Juurlink put it this way: “Any self-respecting developed country has a system in place where health professionals have to report drug problems; there’s no reason why we should be allowed to be lackadaisical.” (Maclean’s writer Anne Kingston does a brilliant job of reporting on our embarrassing track record at post-marketing surveillance and other the troubles with the drug regulatory system.)

5. Our deadliest drug issue: Pharmacare, where art thou?

Did you know that Canada’s is the only health system in the OECD that is universal but excludes public and universal coverage for prescription drugs? And yet, we’re filling more prescriptions than ever, pharmaceuticals make up our second largest health-care cost, and we are second only to the U.S. when it comes to per capita spending on medicines.

According to UBC’s Morgan, this suggests there’s something rotten with our pharmaceutical policy. The provinces have come up with a patchwork approach to covering drugs for some citizens—mostly seniors and social assistance recipients. Employers fill in the gaps. If governments, unions and employers all negotiate drug benefits, Canadians lose out on the efficiencies and bargaining power that comes with a universal, single-payer system.

Worst of all, our so-called universal health system essentially ends for many people when they leave the hospital or the doctor’s office. There’s evidence Canadians who need drugs face financial barriers, even financial ruin, because of treatment costs. One study estimated that about 1 in 10 Canadians who receive a prescription don’t fill it because they can’t afford to.

If every other universal system in the OECD figured out a better way, we can too. “You either see prescription drugs as part of the health-care system, or you don’t,” says Morgan. He added that when Obamacare is fully implemented south of the border, “it’s likely more Americans will have prescription drug insurance than Canadians, so in a sense, we may become the worst country in the world on pharmacare.” Indeed, a pretty serious drug problem.

Science-ish is a joint project of Maclean’s, the 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

An insider’s guide to recovery for addicts and their families

By Julia McKinnell - Tuesday, November 20, 2012 at 3:40 PM - 0 Comments

Photograph by Ben Garvin

Journalist and former White House press secretary Bill Moyers recalls being “devoured by ignorance” when faced with the reality of his son’s crack and alcohol addiction.

It was 1994, and Bill’s son William, also a journalist, had gone off the rails. His terrified family stormed an Atlanta crack house, not knowing if he were dead or alive, only to find the 35-year-old, wasted, in a closet. “I hate you,” Bill Moyers told his son.

When William finally got clean and sober, he wrote a bestselling memoir, Broken. The media exposure generated endless letters from desperate addicts and family members pleading for advice on where and how to get the kind of help that saved him.

Now What: An Insider’s Guide to Addiction and Recovery is William Moyers’s latest book. “I’ll be candid with you,” he said in an interview last week from St. Paul, Minn., where he lives with his three children. “This is not a profound book in the same way that Broken was, but it’s a practical book, and it should get people to a solution. Not the solution, but a solution.”

William, 53, works for Hazelden, a rehab centre, where he always tells alcoholics it’s okay to ask for help the same way it’s okay to ask for help with a broken leg, because he believes it is a disease. To anyone who doubts that, William always responds: “Don’t take it from me. The American Medical Association defined it as a disease in the 1950s. Take it from the AMA.”

It’s an illness of isolation, and the antidote is to reach out and say, “I need help. Help me.” In the book, he recounts a conversation with a colleague at CNN. “I told him everything about myself, even the two or three secrets I’d sworn I’d never tell anyone. When I did, he leaned back in his chair and said, ‘You too, huh?’ And in that instant, I realized I wasn’t alone in the shame and regret that is so much a force of my illness.”

The Internet makes it easy for people to find support. “There are even impromptu [Alcoholics Anonymous] meetings in airports and on cruise ships,” he writes, “usually heralded over the loudspeaker or by handwritten signs using the code phrase ‘Friend of Bill W.,’ ” a reference to AA’s founding father.

William says interventions should not be harsh, histrionic dramas as seen on TV. “Many people, me included, have been plucked from the point of no return because our families didn’t give up on us and hired a trained, experienced interventionist to get involved.”

Remember that the mind of an addict “hardens into an impregnable defiance,” so an intervention might not work, but that doesn’t mean you should close the door. “Stay in touch and stay connected,” he urges. “You will need to set some terms around illegal or disruptive behaviour, but invite him to dinner, include her in family celebrations, meet him for coffee. At the end of every communication, be sure to ask, ‘Do you want help?’ Regardless of his response, always sign off with, ‘I’m here and I want to help you.’ ”

Don’t wait for the addict to hit rock bottom; start calling professionals and support groups and treatment centres, William advises. “It’s a popular misconception that a sick addict can only quit using and start to get help when he hits rock bottom. The ultimate bottom with addiction is death.”

Then it’s time for family members to take care of themselves. “I always remind families that, when their addict stops using and starts to get well, the family deserves and needs to recover.”

William’s mother, Judith, joined Al-Anon, a support group for the families of addicts, which she continues to attend. “I don’t think it does help me,” William said on the phone, “but it helps her.”

Last week, William visited his father in New York. “You know, I’m proud of you, son,” said the man who once spit out the venomous “hate” word. In the book’s foreword, Bill writes: “Our son says he dedicated his first book, Broken, to his parents because we were with him ‘every step of the way.’ Ha! He was too drunk and drugged to see how many times his father stumbled. It seemed to me that every time I put my foot down, I stumbled.”

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

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

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 Killer—The 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.

Burger, please, and a glass of Beaujolais

By Kate Lunau - Wednesday, November 14, 2012 at 8:30 AM - 0 Comments

Reena Newman

At a Hardee’s restaurant in Champaign, Ill., two food psychologists recently did some redecorating. Half the seating area was left as-is—the strong lights, bright colours and hard metal chairs typical of fast-food places—while the other half was transformed with white tablecloths, plants and paintings. “We softened the surfaces to make it quieter, put in nice lights, played some Miles Davis,” says Brian Wansink, director of Cornell University’s Food and Brand Lab, author of Mindless Eating: Why We Eat More Than We Think.

As the lunch rush arrived, customers were randomly selected to eat in the regular restaurant or on the made-over side. Wansink and collaborator Koert van Ittersum of the Georgia Institute of Technology thought people on the fine-dining side would linger at their tables and order more food. But even though those customers spent longer in the restaurant, they consumed less food. And they rated what they ate as more enjoyable.

Restaurants influence us in all sorts of ways—everything from lighting and music to words on the menu can cue us to indulge. The trouble is, for most of us, restaurants are no longer for special occasions; they’re an everyday thing. A new study in the American Journal of Preventive Medicine (AJPM) says Americans spend nearly half their food budget on, and consume about one-third of their daily calories from, food outside the home. Canadians do better; according to Statistics Canada figures published in April, households spent an average of $7,443 on food in 2010, $2,066 of that in restaurants. (In 1997, we spent an average of $5,608, $1,152 of it in restaurants.) All that eating out isn’t very healthy, as the new Symptom Profiler quality-of-life survey results show: the more respondents ate out, the more negative health symptoms they reported. Continue…

The medical lottery: treatment rates vary wildly from one city to another

By Julia Belluz - Tuesday, November 13, 2012 at 12:42 PM - 0 Comments

Ghislain & Marie David de Lossy/cultura/Corbis

Ewan Affleck, medical director of Yellowknife’s health and social services, describes it as “a huge issue that is largely unaddressed” in Canadian health care, in many ways “a hidden secret.” He’s seen it in the places he’s worked as a family doctor, from urban clinics in Montreal to hospitals and nursing stations in the Inuit villages of northern Quebec, and now in the primary-care centres of the sprawling Northwest Territories.

The secret is “unwarranted variation”: the stark and sometimes alarming regional differences in the health care patients receive, determined by things like the capacity of the local system on a given day or the preference of the doctor instead of actual need or even medical evidence. Canadians participate in a lottery every time they have a brush with the health care system; it can mean the difference between getting screened for prostate cancer or not, or whether or not you have your uterus removed. Though medicine is now supposed to be evidence-based, the simple fact of where you get care, and from whom, can influence your treatment as much as the latest science.

This arbitrariness disturbed Affleck, who has the lean frame and single-minded focus of the ultra-marathon runner that he is. “This is a national issue,” he says. “Who drives the Canadian health system? The day-to-day drivers are mostly doctors and other health professionals.” Continue…

Living to 100 is not all in your genes

By Ken MacQueen - Tuesday, November 13, 2012 at 7:00 AM - 0 Comments

Alex di Suvero/The New York Times/Redux

One of the fastest-growing segments of the Canadian population is its oldest citizens, those 100 years of age or more. Between 2006 and 2011, the number of centenarians jumped by almost 26 per cent to 5,825, a number that is expected to double in the next 10 years, and soar to near 80,000 when a healthy generation of baby boomers hits the milestone in the mid-21st century. Today’s centenarians were alive when the Titanic sank and have lived to see robots exploring Mars like photo-snapping tourists. They saw the advent of penicillin, insulin, polio vaccines, pacemakers and publicly funded health care, to name but a few advances that have contributed to longevity. Medical science is only part of the equation; researchers are finding this hardy group holds many keys to the secret of longer, healthier lives for the rest of us.

The world’s largest study of extreme old-agers is the New England Centenarian Study, which has gathered data on more than 1,600 centenarians worldwide since its start in 1995 under founding director Dr. Tom Perls, a geriatrician at the Boston Medical Center. Its website is a treasure trove of studies documenting the unique characteristics and commonalities of those living to extreme old age. Among the myths the studies shatter is that genetics alone account for advanced old age and that centenarians are the lucky few who have escaped major illness.

Centenarians tend to fall into three groups. Just 15 per cent reach 100 years with no clinical evidence of disease. “We call them escapers,” Perls writes in an overview of the studies. Another 43 per cent are “delayers,” those who don’t acquire age-related diseases until at least 80 years. Another 42 per cent are “survivors,” whose earlier bouts with cancers, heart issues or other age-related diseases have not significantly curtailed their lifespans.

The studies show centenarians are a diverse lot, varying in education, socioeconomic status, ethnicity, religion and diet. (An exception to the religion rule are the much-studied Seventh-day Adventists of Loma Linda, Calif., who have an average life expectancy of 85 years, far longer than the typical American’s. In part, researchers believe it’s because their religion forbids smoking and drinking and encourages exercise, a vegetarian diet, a sense of community and a strict adherence to a day of rest and reflection.) The research does reveal characteristics of those likely to reach 100. Many are incorporated into the site’s popular Life Expectancy Calculator (livingto100.com). Among the predictors:

• Few centenarians are obese.

• A long history of smoking is rare.

• At least half of centenarians have immediate family that lived to very old age.

• Children of centenarians tend to follow a parent’s path to a longer life and, like them, tend to be extroverts who are able to handle stress with little evidence of neurosis.

• 85 per cent of centenarians are women.

The disparity between genders is explained in part because women have lower probabilities of dying at all ages than men, who have higher rates of death by accident and misadventure in their early years.

Canadian experts in geriatric care tend to concur with the study’s conclusions. Dr. Samir Sinha, director of geriatrics at Mount Sinai Hospital in Toronto, who was appointed by the Ontario government this May to help craft a seniors care strategy, says a social network, a sense of purpose and engagement, physical exercise and preventive health care are as vital as good genetics. All of those priorities are likely to have a place in Sinha’s report, due late this year. The “poster child” for Sinha’s seniors strategy is a 102-year-old Toronto resident known as Mr. W., a witty and engaged retired architect who lives in a book-filled Toronto apartment. Sinha helped spring him from a hospital bed almost two years ago with the help of his physician, Dr. Mark Nowaczynski, clinical director of House Calls, an interdisciplinary team for frail, house-bound seniors. Though Mr. W. has multiple health issues, he’s not been back to the hospital since. Two Rubik’s cubes sit on a windowsill, testament to his sharp mental faculties. He’s the very essence of the optimistic, socially engaged centenarian.

“It’s not that centenarians have had particularly healthy lifestyles, other than not smoking, but that they have positive outlooks, are generally optimistic and don’t sweat the small stuff,” says Nowaczynski. “To witness Mr. W. expertly flirt with a beautiful young woman in the most daringly gentlemanly way is not only watching an artist at work, but a reminder that age is only time, and his zest for life is timeless.”

When Sinha finishes his seniors report later this year, he’s promised to give one of the first public copies to Mr. W. Like his fellow centenarians, he is both a link to the past and a harbinger of our future.

Richer, happier, fitter? Not for female executives.

By Anne Kingston - Monday, November 12, 2012 at 10:52 AM - 0 Comments

Ghislain & Marie David de Lossy/Getty Images

The richer you are, the healthier you are. That maxim is hammered home in studies conducted by everyone from the World Health Organization to StatsCan, which reveal that income is the greatest determinant of health. Affluence and education are routinely linked to longevity and better fitness, nutrition and quality of medical care. As a medical truism, it’s right up there with “women are healthier than men,” based on the understanding that women visit the doctor more, are more concerned with nutrition and fitness, and are less likely to engage in risk-taking behaviour.

It would follow, then, that women who earn the most should be, and feel, healthiest of all. But that arithmetic may not add up. Women who shatter the glass ceiling are encountering a new gender gap, one that can affect their health in a one-two punch. First, they get equal access to the stress-related illnesses and habits that make male CEOs prime coronary candidates. Then, throw in a second, exacerbating factor: that pernicious “work-life” balancing act that has women, far more than men, contorting themselves like Cirque du Soleil performers to meet the demands of work and home. The upshot is a new female wealth-health paradox: earning enough to afford a trainer, an acupuncturist and a nutritionist, but not having the time to go to them.

A new Australian study, in fact, reveals that female executives don’t even have time to go to the doctor. The survey of close to 400 chief financial officers released last month by research firm East & Partners found most male respondents—77 per cent—had visited their doctor in the past year; only 34.8 per cent of women had. More astounding: 43.2 per cent of female CFOs couldn’t recall the last time they had. Continue…

Thirty-seven and counting

By Kate Lunau - Saturday, October 27, 2012 at 8:00 AM - 0 Comments

Illustration by Patrick Ledger

Brigitte Adams always wanted to have kids one day: a boy and a girl. “My mom’s a first-grade teacher, and there’s a whole library of children’s books she’s saved for me,” says Adams, 40. Two years ago, she talked to her doctor. “He said, ‘Just get pregnant now,’ ” but Adams, who divorced at 34, was single. “I’d like to have a traditional family,” she says. “I wasn’t ready to have children by myself.” Last year, she froze her eggs.

Like Adams, women in their mid- to late thirties are turning to egg freezing to slow the biological clock, putting aside a stash of eggs to gain more time to have a child. Elective egg freezing is fairly new, and not all fertility clinics offer it, but it’s about to go mainstream. On Oct. 19, the American Society for Reproductive Medicine (ASRM) lifted its “experimental” label on egg freezing, citing findings that younger women are about as likely to get pregnant whether using fresh eggs in a fertility treatment, or previously frozen ones. While the ASRM doesn’t set rules for fertility clinics, merely provides guidelines, more are bound to start offering the procedure—and more patients will seek it out. Women late in their reproductive years may be disappointed: not even this cutting-edge technology can halt the female fertility decline.

The ASRM’s new recommendations say egg freezing can help certain women, like cancer patients who might suffer infertility after chemotherapy, or couples using IVF, if the man can’t give a sperm sample the day his partner’s eggs are retrieved. But it stopped short of recommending egg freezing for the purpose of delaying childbearing, especially among older women. “We don’t have good data on women who are older,” says Dr. Samantha Pfeifer, head of the ASRM Practice Committee, which wrote the new recommendations; most of the studies so far have been in women under 30. Egg freezing can be a costly procedure, and takes a physical and emotional toll; there’s concern about giving patients false hope. Yet older women like Adams are the ones “most clamouring for the technology,” Pfeifer acknowledges.

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What to expect when you’re expecting? Crazy headlines about pregnancy risks

By Julia Belluz - Thursday, October 11, 2012 at 2:56 PM - 0 Comments

Getty Images

With the global population ballooning to seven billion, Science-ish wonders whether journalists around the world are in on a conspiracy to lower birth rates by scaring would-be parents with crazy stories about pregnancy risks. Consider the headlines this week: We learned that “depression in pregnancy can slow a child’s development” and that a mother’s fish and mercury intake is linked to attention-deficit hyperactivity-disorder behaviours in her kids.

This isn’t just the result of a slow news week. Science-ish has been tracking the health stories targeted at expectant parents over the last year, and they have ranged from the silly to the farcical, and always with a dash of fear mongering.

Last September, the BBC reported that eating low-fat yogurt—not the Greek, or half-fat types—during pregnancy may induce asthma and hay fever in children. The Guardian reported on a study that linked a mother’s sleeping position to stillbirths, recommending specifically that she sleep on her left side or else risk having one. Would moms be able to sleep at all after that chilling report? Fox News wrote: “Mother’s hypertension during pregnancy may affect child’s IQ later in life” and that “Women who get pregnant while dieting increase babies’ obesity risk.” And there was no shortage of reporting on the scary chemicals in our environment that can harm wee ones, even before conception. A telling headline from Mother Nature Network: “BPA exposure linked to abnormal egg development.”

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Science-ish takes your vaccine questions

By Julia Belluz - Thursday, October 4, 2012 at 6:50 PM - 0 Comments

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Wondering whether you really need to get your flu shot? Or how effective the HPV vaccine is in boys? Whether those immunizations for rabies and yellow fever really were really necessary before your big trip overseas? Or why those childhood vaccine schedules are so darn complicated?

With the kids back at school, and flu season upon us, Science-ish invites your vaccine-related questions. Email to Julia by Wed. Oct. 10 at julia.belluz@medicalpost.rogers.com or tweet them to @JuliaOfToronto and check back within the week for answers.

Until then, here is some reading by Science-ish on vaccines:

The Taliban, polio and YOU
Fighting scary vaccine stories with scarier no-vaccine stories
The flu shot: to vaccinate or not?

And recent vaccine-related news:

Inside the Mind of Worry
Tamiflu and four other prescription drugs doctors had no idea could hurt their patients
Flu vaccine nasal spray an option for kids, teens
Will a flu shot keep you healthy?
A Duty of Health Care Workers
Vaccine development needs a booster shot

Science-ish is a joint project of Maclean’s, the 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

Do surgical checklists really save lives? Yes or no (check one)

By Julia Belluz - Thursday, October 4, 2012 at 11:59 AM - 0 Comments

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After hearing complaints about over-administration from healthcare workers, and, in particular, that the health community was binging on checklists, Science-ish knew something was awry when a poem titled Mister Tick-A-Box arrived in my e-mail inbox from an Australian surgeon-poet-friend.

Dr. Hessom Razavi turned to writing stanzas to vent his frustrations about the checklist culture he saw emerge at his eye clinic and operating theatre in Perth. He was being reduced to an automaton by the directives of “Mister Manager, a.k.a. Executive-Director-Consultant-Supervisor-Coordinator-Liaison Officer,” he scribbled. Instead of patients, he was dealing with “the boxes, the boxes, the cold creep of the b □ o □ x □ e □ s , just waiting to be ticked.”

The eye surgeon wasn’t the first to speak of checklist burnout, and “alert fatigue” over electronic health records is already a well-documented phenomenon. This led Science-ish to wonder about the evidence behind the much-lauded surgical checklist—made famous by the Harvard surgeon and New Yorker writer Dr. Atul Gawande in his book the The Checklist Manifesto. Exactly how effective is this modern medical panacea?

Science-ish rang up Dr. Marty Makary, the Johns Hopkins surgeon who helped to develop the original surgical checklist trumpeted by Dr. Gawande and ferried around the world by the World Health Organization. When asked about checklist fatigue, Dr. Makary voiced his concern that the original surgical checklist—which includes simple elements, such as confirming the patient’s identity while she is still awake; a “time-out” before skin incision, when the medical team checks in about antibiotics and possible critical events; as well as a sponge and instrument count at the end of the operation to ensure nothing is lingering within the patient—has been a victim of its own success, bloated by risk-managers and legal departments in hospitals. “Now, people have expanded them to the point where they are too burdensome, and expanded them to the point where front-line workers don’t find them helpful.” Worse still, “If they are too burdensome, people won’t use them,” he said. “Or they will just say they are using them, document they are using them, and not use them.”

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