Miracle medicine? Or caution, controversy, questionable methodology?

The newspaper dropped “Miracle Medicine” from the headline after we blogged about it

I know what it’s like for patients to tune in when they hear news stories about a condition they have.

I have a form of spinal arthritis known as ankylosing spondylitis (AS).  So when The Globe and Mail newspaper published a story referring to “a miracle medicine” for AS, I perked up. Hmmm, I thought.  I’m pretty plugged into health care news and I’m pretty plugged into my own situation.  So what’s up?

What was up was some unbalanced hype.

The story profiles one man who went from “bedridden to Ironman” after the use of the injectible drug Enbrel (etanercept).

“The effect was miraculous,” the story beamed.  After severe pain, job disability and depression, the man was was downhill skiing and running a five-kilometer race.

The story did cite some evidence:

“According to (a) study, published recently in the medical journal Arthritis and Rheumatism, patients on TNF-inhibitors were 70-per-cent less likely to deteriorate than those taking other medications. Those who waited 10 years or more to begin such treatment were far less likely to respond.

“Before this paper,” says (the lead researcher), “either you went undiagnosed for years, or the GP did not take it seriously, because there was no treatment except over-the-counter anti-inflammatories. Now, we know that treatment with biologics makes a difference.”

But it’s what the story didn’t tell us that you may find most intriguing, possibly even most important.

One reader left this comment online: “Story leaves out the small detail that Enbrel costs $20,000 a year and most provincial drug plans don’t cover the cost.”

That’s pretty important.

How about potential harms of the drug? Nothing in the story on those, either. The known side effects can be ugly, including:

  • Risk of infections, some serious, including tuberculosis (TB), and infections caused by viruses, fungi or bacteria that spread throughout their body. Some people have died from these infections.
  • Risk of cancer.
  • Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use ENBREL.
  • Nervous system problems. Rarely, people who use TNF blocker medicines have developed nervous system problems such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes.
  • Blood problems. Low blood counts have been seen with other TNF blocker medicines. Your body may not make enough of the blood cells that help fight infections or help stop bleeding. Symptoms include fever, bruising or bleeding very easily, or looking pale.
  • Heart failure including new heart failure or worsening of heart failure you already have. New or worse heart failure can happen in people who use TNF blocker medicines, like ENBREL.
  • Psoriasis. Some people using ENBREL developed new psoriasis or worsening of psoriasis they already had.
  • Allergic reactions. Allergic reactions can happen to people who use TNF blocker medicines.
  • Autoimmune reactions, including:
    • Lupus-like syndrome. Symptoms include a rash on your face and arms that gets worse in the sun.
    • Autoimmune hepatitis. Liver problems can happen in people who use TNF blocker medicines, including ENBREL. These problems can lead to liver failure and death.

The story didn’t independently evaluate the quality of the evidence.  It didn’t mention that this was not a randomized clinical trial, and that the researchers admit the limitations of “potential unmeasured confounders and potential biases.”

The story didn’t quote anyone without a conflict of interest – only those touting their own work. And the story didn’t mention that – in the same issue of the journal where the cited study appeared – there was an editorial that said “The controversy continues.”

Controversy?  What controversy? The headline said this was a “miracle”!

Indeed, in the published journal paper, the researchers only concluded, “Treatment with TNF? inhibitors (like Enbrel) appears to reduce radiographic progression in AS patients, especially with early initiation and with longer duration of followup.”

The editorial stated that:

  • “the results of this study should be interpreted with caution.”
  • the researchers “used a new definition of radiographic progression” and said “It is a questionable definition.”
  • “the methodologic robustness of radiographic assessment in the study by Haroon and colleagues is not ideal.”
  • “does the study …provide conclusive evidence that anti-TNF agents have a protective effect on radiographic progression in AS? No, not yet.”

So the editorialist didn’t see a miracle.  Didn’t see conclusive evidence.  Didn’t see an ideal methodology.  But saw a definition of evidence – the whole basis of the study – as questionable.

But, you see, that’s what you get when you seek independent perspectives, as the journal did in seeking an editorial comment.

The newspaper didn’t do that.  It didn’t evaluate the quality of evidence.  It’s not clear that the reporter read the journal article.  And it seems he missed the editorial as well.

So, even though my ankylosing spondylitis is still there, I’m going to pay more attention to the cautions than to the miracle proclamations. Newer is not always better.

P.S. The way things are in online news these days, it should not be surprising that Amgen, maker of Enbrel, was able to place an ad – a big one – bigger than what I’m displaying here – right next to the ad-like news story for the drug.  Caveat emptor.

Addendum on November 22:  The public editor of The Globe and Mail agrees with our criticism in her online assessment, “Careful what you call a ‘miracle.’



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