Monday, August 22, 2005

Medical Studies and the Average American Kid

Full article from the Washington Post today. No commentary. Just 100% copyright infraction.

By Rick Weiss
Washington Post Staff Writer
Monday, August 22, 2005; Page A05

Pop quiz for parents:
Researchers want your 9-year-old child to give up a day of summer vacation to participate in a medical experiment. They need to find out whether a new drug, tested only in adults, is safe for children.

The drug will not benefit your already healthy child, but the researchers assure you that, in accordance with federal regulations, the risks will be no greater than the ones kids encounter in daily life. What do you say?

By that measure alone, parents may be wise to say "No," according to one of the first studies to quantify the risks kids routinely face.

As it turns out, the day-to-day risks of being a kid are considerably higher than many people appreciate, these experts assert. And therein, they conclude, lies a problem with federal rules on research involving children. By assuring that risks will be no more than "routine," they convey a false ring of security.

"Everyone's got an intuition about the risk of everyday life," said Ezekiel Emanuel, chairman of the department of clinical bioethics at the National Institutes of Health. "We thought, 'Wouldn't it be great if we could quantify it?' And once you begin to do that, you realize that everyday life is not benign."

The new analysis, led by Emanuel and NIH co-worker David Wendler, is the latest contribution to a bubbling controversy on whether federal research protections for children are adequate. That debate has grown in recent years as it has become clear that the vast majority of medications prescribed for kids have never been tested for safety or efficacy in youngsters -- a risky situation in itself, since children can respond to drugs very differently than adults.
The federal government is making a major push to have more medications tested in children, offering pharmaceutical companies valuable patent extensions, for example, on drugs that the companies test in kids. But that push has led a number of experts to scrutinize the current standards for such tests.

Of special concern are studies involving healthy children, since they offer no potential benefits to offset the risks. Federal rules allow such experiments with parental permission only if a review board deems the risks "minimal" or, in some cases, a "minor increase over minimal."

"Minimal risk," according to regulations, means that the anticipated harm or discomfort will be no greater than that "ordinarily encountered in daily life or during the performance of routine physical or psychological . . . tests."

That standard has proved squishy. Kids living in crime-ridden neighborhoods face terrible risks every day. If the regulations are interpreted by that standard, those children would be wonderful prospects for researchers wanting to conduct dangerous studies. After all, those kids regularly risk getting shot or stabbed.

To avoid that kind of exploitation, the regulations have been interpreted by the Institute of Medicine and others to mean "risks ordinarily encountered by average, healthy, normal children." But here a second problem arises: Just how big are those risks?

To answer that question, Emanuel and co-workers searched high and low for statistics on the risks of daily living. They got some from the federal Centers for Disease Control and Prevention. Others came from sports organizations. Many others came from individual researchers who had quietly spent their lives compiling statistics about obscure activities that they thought nobody would ever care about.

To get a sense of the risk inherent in a standard medical test, for example -- a standard that the regulations say should be used for comparison purposes -- the team tried to track the fates of people who had taken a glucose tolerance test, commonly given to suspected diabetics. After many dead ends, they found a doctor who had tracked injuries from 14,000 such tests but had never published his work.

Similarly, while looking for data on psychological stress in kids, they came across a study comparing the stress of being young and fat to that of being young and diagnosed with cancer.

"We said, 'Wow, he must have some data,' " Emanuel said. Sure enough, the researcher had stress-related information on 6,000 kids.

The product of all this work, published in last week's Journal of the American Medical Association, provides a comprehensive look at the risks in a typical kid's day that might include a ride in a car (the major risk of death for children), time on a playground or in a sporting event (the major cause of injury), and other routine activities such as bathing or swimming.

Their conclusion: In the course of an average day, kids routinely face risks as high as 1 in 250 of an injury requiring hospitalization or a visit to the emergency room. For young people 15 to 19, the cumulative risk of dying in an accident is as high as one in 100,000 each day.

Those risks may not sound huge, but studies have shown that research review boards routinely reject experiments whose risks are substantially lower than those. That disparity reveals a disconnect between experts' intuitive sense of acceptable risk and the actual risks that regulations allow.

Experts agree that the continued participation of children in clinical trials is very important. Without them, such lifesavers as the polio and measles vaccines might never have been approved, and doctors in the 1950s might never have learned that their use of supplemental oxygen was causing blindness in babies born prematurely.

In their article, Emanuel and colleagues propose a few alternatives -- none of which, they emphasized, reflect the views of the NIH.

One of them, the "de minimus" standard, would require that research risks not exceed the negligible risks people tolerate every day (such as when walking to work), rather than using a standard that includes such dangerous extracurricular activities as playing football.

An alternative is to use the model of charitable giving, to achieve a standard of allowable risk that falls between de minimus and the current standard. Just as people accept certain unnecessary risks because of the benefits they bring (such as the convenience of a car or the fun of sports), people also take risks to help others (such as helping build homes for the homeless). If people more consciously appreciated the societal benefits of medical volunteerism, some argue, a higher level of risk might be justified.

The terrain is an ethical minefield, experts warn. And most agree that changes in the current system must await the results of further research.

"No one's presented an alternative that a good philosophy professor couldn't tear to shreds in about 30 minutes," said Terrence F. Ackerman, chairman of ethics at the University of Tennessee College of Medicine in Memphis.

But after decades of inattention, Wendler said, at least the topic is beginning to be addressed.
"We want safe and effective medicine for kids, but we don't want them exposed to risk, so we've closed our eyes," Wendler said. "This begins a discussion of what the appropriate levels of risk are."

Business Rule #1: Don’t Kill the Client

Maybe it’s my Canadian upbringing. Perhaps its because I was born in the sixties. But I tend to hold the view that not all illegal drugs are created equal. (I know, it's very un-American of me).

For instance, if I found out my son, at 16 years old, was smoking pot, my response would likely be to ask him to consider eating it, since eating marijuana is much less detrimental to his health than inhaling it. (Now, if I caught him doing any drugs of any kind in any way before 16, my reaction would be quite different…“boot to the head!”)

I’ve smoked and eaten pot. Years ago I tried mushrooms (great story there!). And once, some moron put a hit of acid in my drink at a bar. That’s the only time I’ve ever tried what I’d consider a hard drug. I recall feeling almost exactly the same when I dropped acid as I did following surgery when some idiot nurse gave me Tylenol 3’s, even though the red armband I was wearing said quite clearly that I’m allergic to codeine.

Despite not being able to claim empathy for hard drug addicts, I am very sympathetic to those people who find themselves with drug addictions to heroin, cocaine, pain killers, and so on.

I don’t like to hear that a bad batch of some drug (legal or illegal) has caused a bunch of people to die, or even to become sick. So that’s my position on drugs.

I also have some thoughts about business. There’s this concept I recall learning while I was taking some business training that had something to do with spending 80% of your marketing and sales resources on keeping your current clients happy and 20% on finding new clients. An application of Pareto’s Law.

Right now I make a reasonable living as a self-employed writer, strategic planner and documentary filmmaker. If I wanted to make more money, I could switch professions. I could, for instance, become a drug dealer, or maybe the manager of a basement lab that makes heroin and other hard drugs. If I did make the switch, I think I’d still want to apply Pareto’s Law. It just seems to make sense that no matter what business you’re in, your current clients are your most valuable asset.

So why would any heroin-maker or dealer, with two brain cells to rub together, mix their heroin with a drug that boosts muscle growth in cattle?

Do you think it was the chemist who decided this may be a good idea? Maybe he was trying to help the typically too thin heroin addicts bulk up a little.

Or maybe, the heroin dealer is moonlighting as a cattle rancher. Maybe he accidentally mixed the two white powders, making both his heroin addict clients and his cattle sick. Gives whole new meaning to Mad Cow Disease. (Business Rule # 17: Whether it’s on file folders or on little plastic baggies, a smart business person uses labels.)

If you live in New Jersey, New York, Connecticut, South Carolina or North Carolina and you use heroin: be careful. Some boneheaded, failed business-school dealer or chemist seems to have forgotten that his business won’t thrive and survive if he injures or kills his clients.

Sunday, August 21, 2005

A pox on you, CDC!

Okay. So here’s the post I was going to write yesterday, about the blessing that is the chicken pox vaccine.

From MedPage Today, here’s the summary blurb that landed in the inboxes of all list subscribers on August 17:
Chickenpox Vaccine Cuts Cost of Varicella Care
ATLANTA-The vaccine against chickenpox, a disease that was once a staple of childhood, has dramatically cut varicella-related hospital admissions, outpatient care, and the associated costs of the disease.

(Note: to see MedPage Today articles you have to register. It’s free.)

I believe I’ve mentioned this before in another post, but some outrageous percentage of people will never read beyond that summary paragraph. As a result, it’s the most important text in the whole article. As such, it provides the hint to the conclusion we are meant to draw were we to read the whole piece. In this case, we’re meant to think: Hallelujah! Another vaccine success!

In most mainstream news articles, you’ll find that about two-thirds of the way through the story, a contradictory or questioning point-of-view is introduced. This is done to create the illusion that the reporter is fair and objective. In the case of this Teaching Brief (so-called by MedPage Today), no such effort was made.

Blah, blah, blah…stats and laudatory language for the chicken pox vaccine…blah, blah, blah…how many fewer people went to hospital due to the pox... And the final paragraph of the story reads:

Understanding the costs and benefits of vaccine programs is important when decisions are made to recommend or not to recommend new vaccines, Dr Davis said, adding, "costs are just as much a part of vaccines as their benefits."
Sadly, in the context of this article which is focused exclusively on the financial benefits of the chicken pox vaccine, we can only assume that Dr Davis was referring to the economic costs, and not the health costs of the vaccine.

This article made no mention of the number of kids who ended up in hospital due to an adverse vaccine reaction. Or the number of kids who suffered non-hospitalizing reactions that may have a long-term impact on the kids’ health.

This article made no mention of the fact that just this year the CDC was forced to acknowledge that one shot of the varicella vaccine was not providing adequate immunity, and recommended that all kids get two shots. The economic impact of government, insurance companies and parents now having to double their cost-per-kid-vaccinated was not addressed in this article (which only covered data between 1994 and 2002).

This article did not mention the fact that the chicken pox vaccine does NOT provide lifetime immunity and people who get the vaccine must get a booster shot every ten years for the rest of their lives.

This article did not mention the fact that when an adult contracts chicken pox, they fare much, much worse than children do, both in the ratio who end up in hospital and the ratio who die from the infection.

Think about those last two point together…the 37 year old who got the varicella vaccine as a kid, and has forgotten to get a booster shot for the last decade, takes his grade one daughter to school. Dad picks up the virus from some irresponsible family that has chosen to let their kid develop natural immunity to chicken pox. Dad gets really sick. Dad ends up in hospital, misses lots of days of work and maybe doesn’t recover. To hell with the economic impact: what about the emotional and long-term health impacts to that family who has just lost a young father and husband?

Let’s see the spin the CDC researchers put on the impact of the varicella vaccine in 10 or 20 more years, once the cohort of young guinea pigs who are part of this experiment have reached adulthood.

No matter how many ways you slice this one, the chicken pox vaccine is a bad idea for the majority of the population. To any kid who is otherwise healthy, the chance of having a bad case of chickenpox is very slim. (So long as you don’t overdose the kid on aspirin or Tylenol). Let the kid suffer through a few days of the pox when he’s young. Let him develop lifetime immunity.

When chickenpox made its way through my son’s daycare in 2000, every single parent was thrilled to get a couple days off, to stay home and cuddle with our spotty scratchers. Oddly, the CDC doctors would have you think that this was child abuse and an economic detriment to the country.

Saturday, August 20, 2005

Would you want your doctor to put “breaking news” into practice?

Almost every day I read at least one article at MedPage Today. Their tag-line is: putting breaking news into practice.

I was going to post about the recent MedPage Today “Teaching Brief” that lauds the great accomplishments of the chicken pox vaccine, but as I typed that tag-line, “putting breaking news into practice,” I realized that the real story is there. Not in the Teaching Briefs or News Briefs, but in the very philosophy and raison d’etre of this website. Here's what they say:

MedPage Today is the only medical news service for physicians that links consumer medical news and the professional medical analysis needed by clinicians. Through our daily coverage of breaking medical stories and topics widely reported in the consumer media, we provide clinicians with the real-time information they need to address their patients' questions and to find out how new developments might impact their clinical practice.
The problem is obvious when one simply looks at MedPage Today's top News Brief:

Jury Awards $253 Million to Plaintiff in First Vioxx Case

ANGLETON, Tex.-The jury in the first Vioxx (rofecoxib) personal-injury case ruled today that the once popular arthritis agent caused the death of a 59-year-old man. It ordered Merck, the maker of the drug, to pay his widow $253.4 million in compensation.
Breaking news (consumer medical news) about drugs is almost exclusively generated by pharmaceutical companies.

Breaking news (consumer medical news) is typically not analysis of peer-reviewed studies.

Breaking news is always full of hype and hyperbole, dramatic statistics and first-ever findings.

The role of breaking news is not to educate, but to attract readers/viewers which in turn sells advertising.

And why in god’s name would any responsible doctor be interested in “consumer medical news” as a tool to inform them about anything to do with the care and treatment of their patients?

Consumer medical news is by definition dumbed-down so the average idiot can understand it. What value to a doctor in that kind of story?

Having doctors put into practice what they learn from pharma-created consumer medical news is what leads to situations like the Vioxx lawsuit, where millions of Americans, doctors included, bought the PR-line that the drug was a safe and effective way to beat arthritis pain. Maybe it was a great way to deal with arthritis, but it wasn’t so good for the users' hearts. It only took 18 months and some 4,000 deaths to figure that out.

I want to see a list of all the doctors who subscribe to MedPage Today. If mine is on that list, I’m finding a new GP.

Wednesday, August 17, 2005

The Tyranny of Troubled Teens

The New York Times ran an article today called “A Business Built on the Troubles of Teenagers”. Mildly interesting. It’s about families that have kids who are deemed to have some sort of behavior problem that requires professional help, at a cost of anywhere from $5,000 to $10,000 a month. So, in essence, it’s about rich families with troubled kids.

The one paragraph that really caught my attention was this one:

“The teenagers who attend these programs have often been diagnosed with attention deficit disorder or other behavioral problems and are taking medications. Some have used drugs or have been sexually abused. Many have been in trouble at school or in minor trouble with the law. Others have run away from home or stolen from their parents.”
Aside from the kids who are sexually abused, which I think would be a damn good reason for a kid to have a behavior problem, the rest of this list of problems that land the kids in Troubled Teen Camp seem pretty lame to me. Have you never used drugs? Did you never get into trouble at school? Have you never had minor trouble with the law? Did you ever run away? Or steal anything from your folks?

I have a theory. It is mine. It’s based on my own experience as a teenager, some 20 years ago; my experience as the mom of a kid who some people have labeled behavioral; and my experience as the step-aunt of a 16 year-old boy who’s back in juvie lock-down this summer, for a third time in three years.

Here’s the theory:

You take a pre-teen, say 9 or 10 years old. He’s misbehaving in school, goofing around too much. Teacher tells the parents to take the kid to see a doctor. Doctor says he has ADHD and prescribes a stimulant drug. The kid takes the drug, settles down to the teacher’s liking. All is good in the world.

Or not. What does that kid believe about himself, his emotions, his personality now? He’s going to believe that there is something wrong with him. Something about him that is not right and needs to be changed through psychotropic drugs. Drugs not unlike cocaine, by the way.

At 9 or 10, the kid has become a legal drug addict who understands that drugs change the way he feels and acts. He believes that drugs that alter his mood and personality are a good thing. The drugs make him more likable to his teachers and probably, to his parents as well.

This unspoken message to a young kid, that his personality needs to be adjusted with drugs, is probably not doing a whole hell of a lot to help him build healthy self-esteem.

A few years go by. The kid’s now 14. He’s rebellious despite the doctor-approved drugs he’s taking (or selling for $10 a pill to his classmates who know that grinding up Ritalin and snorting it provides a really good high).

His parents are on his case about some stupid thing so he runs away. In fact, he probably just stays a friend’s house without telling his folks.

And/Or he really wants some new Nikes but his mom won’t cough up, so he steals $60 from her wallet and buys the shoes.

And/Or he’s out with a gang of buddies and they stupidly think it would be a good idea to break into the corner store to steal some chips and beer.

Odds are, at 14, he hates school and is getting mediocre grades. Or worse, he hates school because he’s bored to tears and so he gets lippy with his most boring teacher. (In my neighbourhood there’s a program for teens who either quit or were kicked out of regular high school. Almost half of these kids test gifted.)

Is this a bad kid who needs to go to reform school, Troubled Teen Camp? Maybe some are. But the article indicates that this is a growing industry. Like the growing industry of putting our moody teens on antidepressants and our hyper kids on stimulants drugs. Quick fix band-aids that do nothing to address the root of the behavior. And in some cases, I’d argue, behavior that simply needs to be tolerated while the kid finds his natural place and voice in the world.

Kids aren’t easy to raise. Parents who expect their kids to behave perfectly all the time, to always follow (often stupid or arbitrary) rules, and never break (often stupid or outdated) laws, should not be allowed to parent. And parents who ditch their teens when they start to exhibit rebellious streaks, or their grades start to fall, or they get caught with pot, should be the ones sent to correctional camp. Especially those parents who model the behaviors they don’t want to see in their kids…but that’s a whole other rant.

I think our expectations for kids to act more mature than their natural ability, older than their age, has gone to an extreme. We can place the blame on many shoulders, but ultimately, it’s the parents who have to decide how to handle their challenging kids. And, in my opinion, making the decision to first drug then boot camp away the undesirable behavior, is much less humane than taking the time to listen to your kid’s reasons for acting up. In my experience (as a teen, a mom and an aunt) kids can have some pretty compelling reasons for acting the way they sometimes do.

Monday, August 15, 2005

Get this guy an agent!

Just found a very entertaining blog post about many candies that mimic adult addictions: cigarettes, chewing tobacco, pot…check out You'll Only Get Sugar High From Pot.

And Rocky Road Scholar’s “Behind the Cereal Box” series, which tells us where all the old cereal mascots are now, is a riot!

Saturday, August 13, 2005

I'm not dead yet

The first week of not posting was pure hell.

The second and third weeks I didn't even consider blogging, given I was experiencing a world like I've never experienced before: in an American protectorate of all places. A tiny island in Micronesia, part of the Commonwealth of the Northern Mariana Islands. A little place called Saipan. North of Guam. Just a quick boat ride from Rota. You probably heard of Rota last week. It's where the A-bomb headed for Hiroshima was launched, 60 years ago this month.

It was an honour to work, for a short time, on Saipan, with folks working to protect the coral reefs in that region. Felt disingenuous to be ranting about bad journalism and unethical pharma practices in a place where history is so rich and I am so obviously just a (mostly) insignificant player in the circle of life. (Okay, significant to my son, but aside from him...not so much significant).

Coral reefs, baby. That's where life on this planet starts and stops. Gotta keep the coral healthy or every other ecosystem, first in the ocean and then on land, will suffer.

Despite the fact that the USA uses one of the islands in the CNMI as a target for aerial bombing practices, I think the US government is doing more good than bad for this set of islands. It was a hard pill to swallow, coming to that realization. Given that self-loathing of my half-American-blood is a key definer of who I am, I didn't know how to come to terms with liking that part of me I've always loved to loathe.

Makes me rethink all of my firmly held beliefs. Relax my stridency. Look at the world from outside my fishbowl - a fishbowl that has been focused on looking inside the American fishbowl.

Where will it all lead? Who knows. But I pray to god that it doesn't lead me to finding God...that would be just too much. Finding some good in US foreign policy AND finding God. How could a Canadian socialist atheist resolve that kind of Christian Republican identification? The only way I can think of is with some of those pharmaceutical drugs I'm usually too happy to condemn... or maybe if I licked one of the fluorescent blue fish I swam with around the reefs...

Oh dear. Encouragement, anyone?