Sunday, February 12, 2006

FDA’s caution may be killing people

The work I do with the 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!


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