Think critically about treatment recommendations: The H1N1 example…

Patients are asking me about the H1N1 vaccine. Usually, as a “one more thing” question at the tail end of a visit.

This question churns the angst machine. The face twists in unknowing.
It doesn’t have to be so bad. Could just give the party line and say, “get the shot.” Have a nice day and we’ll see you later. Easy, right? Move on, John, you are behind already. It gets dark really early these days.
Problem is, us arrhythmia specialists are spoiled by our science. Treatments for cardiac rhythm issues have been thoroughly studied in carefully controlled, large, randomized trials against placebo. There are major New England Journal studies published that support the benefits of therapies like catheter ablation and defibrillators. Real studies with real outcomes against placebo. Science. Purity.
The difficulty with answering a simple request on the swine flu vaccine are numerous….
H1N1 gets much press, but, as a statistical danger is quite meek. In the first 300 days of 2009 it has proven 0.77% as dangerous as traffic accidents and .005% as hazardous as cardiovascular disease.
Secondly, due to the media hype, the H1N1 vaccine has been rushed to market. It is untested. How could it be tested?
Thirdly, there is little data to demonstrate efficacy. How does one know? There are no comparisons between large cohorts of vaccinated individuals against unvaccinated. For example, let’s just say the vaccine prevented 10,000 cases of swine flu and one death, but caused 10 major complications and one death. It would be a statistical wash. These comparisons have not been done.
We cardiologists are skeptical. History helps us. In the 1980’s there were medicines that effectively suppressed premature beats (PVC’s) after a heart attack. As post-heart attack PVC’s conferred a worse prognosis, it reasoned that suppression would be good? A no brainer, right? However, when compared to placebo, the drugs did suppress the extra beats, but, the group who took the drug had a much higher death rate. The drugs worked as expected, but unexpectedly, resulted in a higher death rate.
I am not saying the vaccine is dangerous, deadly or ineffective, only that there is insufficient prospective data. It is unknown. The recommendation to vaccinate comes not from scientific comparisons, but rather, from a consensus of “experts.” How do they know? Is it grey hair, PhD’s, nice white coats or “they just know?”
Compare the 8000 global deaths this year from swine flu versus 14 million from cardiac disease or 6.4 million from cancer. Where is the balance?
A larger point: when a therapy is recommended for you, ask yourself or your doctor if there if there is good science to support the treatment. “Expert” recommendations pale in comparison to real trials with real patients and hard endpoints. Think.
The H1N1 vaccine question illustrates perspective.
My answer is, “I do not know.” We will probably know in the future. Based on the above link the answer for most of my patients is: they are 5000 times more likely to die from heart disease and 100 times more likely to die in a traffic accident.
Not knowing is OK, as long as, you know that you don’t know.
JMM