Tuesday, February 21, 2006

The fine print communicates loudly

Yesterday I was facilitating a communications workshop on message development and audience profiling to a small group of civil society organizations here in Sri Lanka. I was very happy to have the image of the vaccine billboard to use in my presentation as an example of how to use a positive message for an issue that could easily be communicated using negative language (an image of a child with a disease as opposed to the love of the mother who protects her child from a disease).

ANYWAY! Seeing the image projected on a wall I noticed the GSK logo...which I hadn't noticed when I saw the billboard on the street! I made an assumption that the billboard had been purchased by an organization like the Pediatric Association or some other non-profit interested in child heath... why would I think that?! Because in Canada that's who would deliver this message - not th ecompany making the vaccine.

The last thing I taught to the group in my workshop yesterday was about the importance of having the right messenger deliver the message. You can develop the best message possible for your target audience, but if the messenger is not credible, then the message will be lost.

Do you think GSK really cares about the health of children in Sri Lanka? Of course they'll say the do because being a "caring company" is good for business. But the bottom line is, their bottom line, not protecting a child from chicken pox or hepatitis.

If you haven't yet seen it, I highly recommend you rent or purchase The Corporation. Life - or at least my view of it - will make so much more sense once you see this film.

Sunday, February 19, 2006

Vaccine Billboard in Sri Lanka

I walked passed this sign in a non-tourist part of Colombo, Sri Lanka yesterday. Not sure how I feel about it. If it were in downtown Vancouver, my feelings would be clear, but in this country, I have no idea what the impact of hep B and chicken pox is on kids...funny though, that this ad is promoting the two newest vaccines in the arsenal.

Monday, February 13, 2006

FDA's caution, Part 2

If you didn’t read yesterday’s post, check it out before you read this post, which picks up where I left off yesterday (if you want to, of course. There’s no coercion here at Shattering Rose-Coloured Glasses).

For those readers, who, like me will not follow the instruction to read yesterday’s post, because they were asked to, here’s a link to the article I’m discussing:

The four most dangerous words in medicine: First do no harm

So let’s start at the CBC. Being a proud Canadian, and just a little left-of-centre in my political views, I turn to our national broadcaster for most of my daily news needs. And, when I want to know about good journalistic principles, the CBC is the first place to look. Here's what they say:

Information programs must reflect established journalistic principles:

The information conforms with reality and is not in any way misleading or false. This demands not only careful and thorough research but a disciplined use of language and production techniques, including visuals.

The information is truthful, not distorted to justify a conclusion. Broadcasters do not take advantage of their power to present a personal bias.

The information reports or reflects equitably the relevant facts and significant points of view; it deals fairly and ethically with persons, institutions, issues and events.

Application of these principles will achieve the optimum objectivity and balance that must characterize the CBC's information programs.

I assume that if you’re reading my blog you’re at least as smart and thoughtful as I am – likely smarter and more thoughtful. So I’m inclined to just let you apply those journalistic principles to the following first four paragraphs of the article in question and let you draw your own conclusions about the journalistic quality of the story…

But, because I get such joy in tearing apart other people’s writing, you can follow along with my analysis and contribute your own ideas to the comments.

Now, in case you’re one of those “scan-readers,” I’m going to highlight a few key words and phrases that jump out at me and lead me to conclude that this piece of journalism is not as balanced or unbaised as it would have been had the CBC run it. (Not that the CBC is perfect…)
(NEW YORK) FORTUNE - When Friday's announcement came it was hard to see it as anything but wonderful news -- the FDA had approved a vaccine called RotaTeq, made by Merck & Co., which had the potential to stop a deadly viral epidemic in its tracks.

Here was "an important new tool," said the FDA's Jesse L. Goodman, MD, that could "effectively prevent an illness that affects almost all children within the first few years of life." The plague, called rotavirus, causes severe diarrhea, vomiting, and fever in infants and toddlers that, if unchecked, quickly leads to dehydration. And in much of the developing world, that can mean imminent death.

Estimates -- which may even be low -- are that some 600,000 children succumb each year to rotavirus gastroenteritis. On the scale of human misery, then, this bug is a biggie. So what could be wrong with a medical marvel that could conceivably end its reign?

Well, nothing -- except that this very happy ending caps a tale that is otherwise quite terrifying. You see
Merck's (Research) RotaTeq (and a competing product from GlaxoSmithKline (Research) called Rotarix that is approved in a number of countries, though not yet the United States) aren't the first miracle weapons designed to fight this disease.

And now, to draw on my annoying language deconstruction tendency that caused my parents so much grief:

wonderful news” – how could the writer (who is the editor-at-large, not some green J-school grad) draw such a conclusion unless he was imposing his bias? I think he stretches the rule of accuracy and breaks the rule of integrity here. He’s reporting that a new vaccine has been approved by the FDA. Wonderful news? Sure, if you have shares in Merck & Co and the vaccine takes off.

deadly viral epidemic” – want to define this for us? Deadly to whom? The writer will tell us later, but most readers will never finish this article. The headline, lead and first few paragraphs are all most readers have patience or interest in reading. So, a majority of readers will leave this article with the impression that rotavirus is a much larger problem than it actually is. And, probably, with a misguided idea of whom the disease is most deadly for.

And how big is the epidemic? Actually, can rotavirus even legitimately be called an epidemic? Do a google define: epidemic search and read the definitions from academic institutions. My read is that rotavirus does NOT meet the definition of an epidemic.

plague” – see “epidemic.” Same thing applies. This is a clear-cut case of fear-mongering language.

if unchecked, quickly leads to dehydration” – "if unchecked" is an easy little phrase to overlook when sandwiched as it is. If unchecked, any vomiting child, regardless of the cause of the vomiting, will become dehydrated. Dehydration is not caused by, or the result of rotavirus. It’s the result of inattentive parenting. More fear-mongering.

imminent death” – fear-mongering. And this imminent death is for children in developing countries, not the babies that the readers of this article will most care about: their own American flag-waving progeny. How many American babies die from rotavirus? Well, this article goes on to say, “In the United States, where rotavirus is rarely deadly…” We can’t quantify the risk, so how can a mom make an informed decision about her child’s need for the vaccine?

Estimates – which may even be low” – or, may even be high. If the number is an estimate, that means we don’t know how many children “succumb” to rotavirus. By saying the estimate “may be low” the reporter leads readers to conclude that, if the number is not accurate, then it is low. That's innaccurate reporting.

600,000 children succumb” – lots of kids are dieing from rotavirus. Sounds very scary. And it is – if you’re a malnourished child in a developing country who has no access to clean water. But here in North America…scary? Not so much. Say it with me, “fear mongering.”

human misery” – my heart is bleeding. Now, if this article moved to the story about how the vaccine was being made available, for free, to the countries where the human misery and deaths from rotavirus are actually occurring, then that phrase would be acceptable. But that’s not close to where the writer takes us. (At US$187 for three doses, I’m guessing it will be years before the kids who really need this vaccine will ever get it).

medical marvel” – please. Nice alliteration. Not so good for objective reporting.

a very happy ending” – again with the reporter’s (or the industry’s press release’s) biased opinion.

miracle weapons” – notice the structure of these first four paragraphs. First we’re bombarded with fear-mongering language like deadly, epidemic, plague, misery, and succumb, and then – the news we are desperate to hear – we don’t have to suffer and die! A medical marvel, the miracle weapon called RotaTeq is our salvation.

Vaccines are a frigging sacred cow in society. And using language like “miracle weapon” to describe a vaccine further entrenches the belief. Bow down before the doctor with the hypodermic needle, for He is your salvation. (Now that is my side-step into loss of integrity, accuracy, fairness and objectivity. Where’s an editor when I need one?)

There’s tons more to this article to look at…it’s a brilliant case study. I’m having so much fun I want to change my day job so I can just spend my time deconstructing stories like this one.

Maybe tomorrow I’ll pick it up again. Part three. Maybe something else will catch my interest…

Sunday, February 12, 2006

FDA’s caution may be killing people

The work I do with the MediaDoctor.ca project has taught me a lot about how medical news is created and the shortcomings in the reporting of health-related stories.

Top of the list, which I really should have put-together given my day-job, is how reliant health reporters are on industry-generated press releases for their stories. Not just what the story will be about, but the focus of the story and the tone of it.

What does this mean? Well, let’s say, for instance, there’s a new vaccine (It’s Monday…vaccine news day) that will save us from ourselves. And, let’s say this is a vaccine to protect small kids from severe diarrhea. And the severe diarrhea has a medical label: rotavirus.

Ring any bells? Several years ago a vaccine to protect infants and toddlers from rotavirus was put on the market in the U.S. It was called RotaShield. Starting in 1998, over 1 million babies received the new RotaShield vaccine. And then, quick as the runs start, it was voluntarily pulled off the market. Big pharma pulling a new drug off the market less than a year after it's launched doesn’t happen too often.

Why was it pulled? Because it was killing babies. Nobody could argue the facts that this vaccine was causing a rare and deadly type of bowel obstruction called intussusception. Unfortunately, I can’t recall or find the stat of how many babies actually died as a result of RotaShield-induced intussusception. (And the article that I suggest you read uses statistical trickery to tell us that babies died, without telling us how many. If you read closely and you’ll see how.)

That’s the background story.

So take a minute or two now and navigate yourself away from my blog and read the following article from Fortune. But please come back after you read it! I’ll teach you a few of the things I’ve learned over the past nine months about how to read and analyse a health story…

Oh, and be sure to look at the title of this page in the lower bar on your computer screen. The title of the page is not the same as the headline on the webpage…it’s just a tad non-objective…just a wee, little, tad…

The four most dangerous words in medicine: First do no harm

Quite an intriguing headline. Ten points to that headline writer!

The lead, or the first text just below the headline reads:
The approval of a rotavirus vaccine is the happy end to an otherwise terrifying saga.

I could spend this whole post just on that one sentence and how non-journalistic it is. And how inappropriate for a health story it is. There are three elements to that lead:

  1. The approval of the rotavirus vaccine
  2. The happy end
  3. An otherwise terrifying saga
Back in Grade 4 – when I was nine-years old – I was taught how to deconstruct arguments into their elements to either prove them logical or prove them illogical. (I think that was when I was introduced to Socratic argument…and the same year my parents signed me up for boarding school in England.)

Back to that sentence. We can’t take issue with it’s logic. And that gives this sentence strength and leads us to assume that since it’s a logical sentence it must also be true, a statement of fact. Since we don’t know otherwise, given the sentence makes sense, most people will naturally deduce that it is true, too.

But thanks to Mr. McAdam and the logic and rhetoric training he provided me and a handful of other precocious nine-year olds, I don’t accept what I read as “truth” so easily.

I can’t argue with the first clause, that a new rotavirus vaccine has been approved. It’s a fact, that I can prove because every news media outlet has told me so. (I hope you read the sarcasm in that last sentence…).

The two elements of the second clause, “the happy end to an otherwise terrifying saga,” I must take issue with.

How on God’s green earth can the assertion be made that the approval of a new vaccine is the happy end to anything? We saw with the previous rotavirus cure that in under a year the vaccine caused children to die and had to be withdrawn.

This new vaccine has been tested on close to 70,000 children. None of the 70,000 of the test group died or suffered any serious complications, but they are almost certainly not representative of the population of children who will start to receive this vaccine once it hits the market.

Why? Because kids (and adults) who are used as guinea pigs for new drugs, are typically chosen based on very specific health criteria. In the case of a vaccine, those kids would almost certainly have been identified as healthy, overall; of not having any pre-existing medical conditions. Certainly, they would not have any previous indication of bowel problems.

And sticking with the “happy end,” below is data about the side effects of the RotaTeq vaccine. You can find this if you link from the press release that the FDA issued to announce their approval of the vaccine.

Read closely. It may not appear logical at first. Or on second reading. Or third. I certainly wouldn't want to be on the "happy end" of the bum in the diaper that got this vaccine!

6. Are there are any possible side effects associated with the use of RotaTeq™?

During the studies, rates of serious adverse events were similar in infants receiving RotaTeq™ compared to those infants who did not receive the vaccine.

The following were reported more often in infants who received RotaTeq™, when compared to those who received placebo;

  1. diarrhea (24.1% in vaccine recipients vs 21.3% in those receiving placebo),
  2. vomiting (15.2% in vaccine recipients vs 13.6% in those receiving placebo),
  3. ear infection (14.5% in vaccine recipients vs 13.0% in those receiving placebo),
  4. runny nose and sore throat (6.9% in vaccine recipients vs 5.8% in those receiving placebo),
  5. wheezing and coughing (1.1% in vaccine recipients vs 0.7% in those receiving placebo).
The most important problem here is that we have no idea what ingredients were in the placebo that was used as the control. We may assume that it was a benign saline solution. But that would be foolish and, very likely, not the case. Most vaccines, believe it or not, are tested for their safety not against a benign solution, but against an existing vaccine!

Since most vaccines cause some kind of reaction in children (diarrhea, fever, and uncontrollable crying are three pretty common ones), this new rotavirus vaccine could, in fact, be causing not just a 3% increase in diarrhea for kids who get it, compared to kids who don't - it could, depending on the control placebo, be causing 24.1% more diarrhea cases. Does that makes sense? I need someone smarter than me to post a comment to explain that better than I just did.

Okay, so this post broke the cardinal “short is better” rule-of-blogging 750 words ago. I’ll end it here and address the actual content of the story tomorrow. Come back. It'll be good!

Thursday, February 09, 2006

Two million bad kids, 19 dead ones

I opened this email news alert today and felt a wave of nausea. Light-headed. And then a little weepy.

Strongest warning suggested for ADHD drugs

2 million children are prescribed the drugs every month

WASHINGTON (AP) -- Ritalin and other stimulant drugs for attention deficit hyperactivity disorder should carry the strongest warning that they may be linked to an increased risk of death and injury, federal health advisers said Thursday.

The Food and Drug Administration advisory panel voted in favor of the "black box" warning after hearing about the deaths of 25 people, including 19 children, who had taken the drugs. The vote was 8-7, with one abstention.
Yeah, it’s the CNN.com version of reality, but that makes this even more shocking. CNN is usually pretty pro-corporate agenda in its spin.

It wasn’t the 19 deaths that made me feel ill and sad. It’s the fact that two million kids take ADHD drugs each month in the States. Two million children are being told, day-after-day with every pill they take, that their personalities are not “right” and need to be changed. What else can a child interpret from being given a drug that has the express objective of changing his behaviour, natural personality and how he interacts with the world?

Two million kids growing up to believe that their natural childhood enthusiasm for life needs to be tempered. That their excited and hyperactive energy needs to be dampened. That their boisterous behaviour is irritating to others and that those others’ needs are more important than their own need to express themselves in the most honest way they know.

I felt ill because my own son was given a label by his after-school care-givers and placed with eleven other kids who they identified as high needs kids. Kids who either were taking behaviour-modification drugs, or, as I was told in my son’s case, should be taking the drugs. (Turns out he has a wheat allergy and every day they fed him bread, muffins and crackers…eliminate the wheat, eliminate the behaviour issues).

It is certainly very sad that 19 children have died as a result of taking ADHD drugs. But in my mind, what’s even more sad is that two million children are living -- growing up to believe that they need drugs to fit into society.

Anyone want to bet that those same kids will be the highest illegal drug users as teens and young adults, the demographic most likely to get hooked on hard drugs? These kids, who from a young age understood that taking drugs made them feel different and that when they felt different, they were actually more likable… that's the saddest part of this story.

Wednesday, February 08, 2006

Of donuts and data

You know those annoying phone calls everyone gets from time to time…the phone rings, you pick it up, and there’s a second or two of silence. You know that the person on the other end is not a friend. He or she is a telemarketer, wants to sell you something or is working for a market research company.

I get a couple of these calls a week. Unlike many of my friends I neither hang up on the caller nor do I verbally abuse them.

I used to work the phones in a market research company. It was the only job I could find when I first arrived in Vancouver 14 years ago. It was miserable. I empathize with the people making minimum wage, hating what they’re doing and not caring a whit about what they’re trying to sell or the research data they’re gathering.

“Hello M’am. How are you tonight?”

First thought in my head was, “I feel like shit. I was dealing with lawyers today, trying to settle assets with an ex who doesn’t want to settle assets.” I said, “fine, thank you.”

“Do you have 9 minutes to participate in a research study?”

“Depends. What’s it about?” I refuse to participate in market research about food or cars or financial institutions.

“Important issues, M’am.”

Well, that’s clear enough. “Sure,” I said.

“What’s the most important issue facing Canadians today?’

First thought in my head was healthcare. But I didn’t want to say healthcare. Everyone says healthcare. It’s the issue we’re told is the most important by new media, day after day. I don’t believe healthcare is the most important issue, even though it was top of mind. I thought for a couple of seconds, “the privatization of public resources.”

First five minutes of the survey focused on the federal government: would I vote for the Bloc? The Conservatives? The Greens? The NDP? The Liberals?

In that order. Isn’t that odd?

And then two questions about the leadership potential and credibility of 10-12 politicians, starting with Belinda Stronach and including Ken Dryden, Bob Rae, what’s-her-name-Liberal-who-quit–when-she-lost-the-leadership-race, and a handful of folks I didn’t know enough about to judge.

From there: questions about health care. A-ha! Further proof that health care is the most important issue facing Canadians today.

“M’am, do you think that doctors make prescribing decisions based on a) ensuring the best care for their patients, b) controlling health care costs or c) their salaries?”

I hate multiple choice questions that limit my answering ability. What about option d) which pharma rep was last visiting their office with a box of Krispy Kreme donuts and tickets to the Canucks? Or option e) the drug they saw advertised on TV while watching the Seahawks get their butts kicked?

Then the same question about federal government bureaucrats and provincial governments. Then a new set:

“How important are bureaucrats in determining which prescription drugs Canadians take?”

I said, “I don’t understand the question. Is that how important are they or should they be?”

“It’s your opinion M’am.”

I still didn’t understand but answered a whole series of this same question: how important are doctors, nurses, provincial governments, pharmacists, the patient in determining which prescription drugs Canadians take?”

Then some questions about some new federal prescription drug initiative that is supposed to address the disparities between the drugs available to people who have private health care insurance and those who are on provincial plans and those who pay out of pocket.

One question asked if I believed people with private health insurance should get access to more drugs than people who are on provincial plans. What the? Of course not!

I got through the survey and was asked the demographic info: my age, household income, and then my postal code.

I wanted to lie. I thought about it. But I couldn’t remember the postal code for the fancy part of Vancouver. I live in the postal area that had the highest “no” vote in the Olympics referendum. The same postal area that voted NPD provincially when all but two seats went to the Gordon Campbell Liberals. The postal area that is arguably the most progressive in BC.

I’m certain I heard the interviewer’s computer go “ping.” My third eye visualized the screen she saw, “Delete this interview? Please select Yes or No.” She sighed. Thirteen minutes wasted. She won’t make her quota for the night. Tomorrow she’ll be given a list of numbers in a neighbourhood where only 20 percent of residents speak English fluently.

I reconsidered what I think to be the most pressing issue facing Canadians today: too many people living their lives pay-cheque to pay-cheque, hating the work they have to do, to feed themselves and their families.

Sure, I had a bad day, dealing with lawyers. But I am blessed to be in a position to even have a lawyer.

The old telemarketing firm I worked for is just around the corner from my office. Tomorrow I think I’ll pop in with a big box of Tim Horton’s donuts for the young men and women who are responsible for doing the research that provides the media with headlines like, “Canadians support privatization of healthcare.”

Sunday, February 05, 2006

If you have the science, show me. If you don't, shut up!

What a weekend! Another I’ll long remember.

A surprise fortieth birthday party, organized in Vancouver from Seattle…my sister is amazing! My friends – many of whom I’ve had in my life for twenty years, some of whom have “only” been walking along my life path for a couple of years – are the most supportive and loving gang of people ever brought into one life.

I am truly blessed.

In addition to a party with so many old friends, I also met with someone for the first time this weekend. The professor who founded the Neural Dynamics Research Lab at the Vancouver General Hospital: Dr. Chris Shaw. And our meeting, I predict, was one of those transformative events that happens so rarely in life: Prof. Shaw walked into my house this weekend (with potted flowers in honour of my birthday...is that nice or what?) and offered the missing third leg of the stool that I have been trying to make stand for nine years.

Background: Nine years ago I looked into the whole childhood vaccine issue. Being a naturally skeptical person, I was not able to provide consent to vaccinate my newborn son until I knew more about the danger of the diseases and the safety of the vaccines than what my doctor could tell me. As I’ve mentioned (perhaps too many times!), that research lead me to the position that, as parents, we do not receive enough information to make an informed decision about childhood vaccinations.

The first leg of my stool is the knowledge and experience that I have about how social marketing and communications is used to influence public beliefs and behaviour – such as accepting that every healthy infant/child needs 40 shots of 12 different diseases in his first five years of life, if he is to remain healthy.

The second leg of my stool is Alan Cassels, whom I met and started to work with six years ago. Alan is a well-known and respected health policy researcher at the University of Victoria, a journalist and author. His knowledge and expertise about how health policy is made adds critical context to the social marketing aspect of the vaccination issue.

Missing for the past six years, however, has been the science leg of the stool. Until now (or very soon from now, once his research has been peer reviewed and published), there has been no way to assert that vaccines could be causing harm to our children (and our soldiers, and our elderly populations and well, anyone who accepts the shots, really). Without the science to prove that vaccines are not as safe as government health agencies, doctors, and the public have been lead to believe they are, the marketing and policy legs simply did not stand.

The science that Dr. Chris Shaw oversaw in his research lab, undertaken by grad student Mike Petrik, proves that the adjuvant aluminum that is used in some vaccines causes neurological damage in mice. Significant damage. Statistically significant neurological damage – in mice.

Interestingly, Shaw and Petrick did not set out to study vaccines at all – they were looking for clues about the possible causes of Gulf War Syndrome. Their research lead them to look at the anthrax vaccine, which lead them to the aluminum adjuvant – an adjuvant that is used in several different vaccines, including many given to infants and children.

Petrik’s research is the first ever to be done (since one very inadequate study done in the 1940s) to even look at the impact of aluminum adjuvants in/on a brain. Despite the fact that aluminum has long been known to be a neuro-toxin. Aluminum has been added to vaccines for 80 years and this is the very first time a researcher has made the effort to see if aluminum could have any impact on neurological functions. Does this make sense?

Despite research never having been done to prove it, for a century we’ve been assured that vaccines are safe. This begs the question of how such an assertion could have been made in the first place, and then why that unproven assertion was accepted by the establishment, and finally, how an unproven assertion has not only survived for 100 years but has become so entrenched in popular belief that to challenge it is akin to blasphemy?

The answer: social marketing and public policy. Three legs of a stool that, if the stars continue to align as they have been, will make 2006 the year that Vaccine Nation is produced and published. 2006, the year I turned 40; the year that starts the slow process of replacing a belief we "know" to be true (that vaccines are safe) with the oppositional knowledge that will bring that belief to its knees.

The sacred cow may fall in my lifetime. And with it, perhaps, a medical paradigm that never should have been accepted in the first place.