Sunday, September 06, 2009

The Background Is Always In Motion

 

 

# 3703

 

 

During the ill-fated pandemic vaccination program of 1976, a rare but serious side effect of the shot caused roughly 500 cases of Guillain-Barre syndrome (GBS), and was linked to 25 deaths.

 

When the swine flu virus failed to materialize that fall, the newspapers and media had a field day with the decision to vaccinate the nation, and the claims (many unproven) of damages to vaccine recipient’s health.  

 

Had the swine flu struck in the fall of 1976, as feared, these side effects from the shot would have been viewed as regrettable, but acceptable losses.

 

We accept that a certain number of deaths will occur each year due to medications, and nobody blinks an eye.  While the loss of 25 lives in 1976 to the vaccine was tragic, consider that:

 

Aspirin and other NSAIDS are linked to thousands of deaths in the U.S. each year. (Unnecessary Prescribing of NSAIDs and the Management of NSAID-Related Gastropathy in Medical PracticeAnnals of Internal Medicine)

 


All medicines have risks.  Even over-the-counter medications. Some are known, while others are so rare, we have trouble measuring them.  It is always a balancing act - a risk-reward calculation - when deciding to take any medicine. 

 

There is no such thing as a completely benign drug.  We accept the risk because these drugs (generally) provide a tangible benefit, one that offsets the danger.

 

And the same goes for flu vaccines.  Serious side effects are exceedingly rare, but not unheard of. No one can promise you that a vaccine is going to be 100% safe.

 

While vaccines have (generally minor) risks, you also have to consider the risks of not being vaccinated

 

Unlike 1976, the novel H1N1 virus is not a theoretical problem, it is already here.  And already killing people. 

 

For an analysis of the relative risks of the virus vs. the vaccine, I’ll direct you to a blog I wrote in July called  Flu Math. In it, I show that this novel virus is at least 80 times deadlier than the much maligned flu vaccine of 1976. 

 

The problem of course isn’t just how safe this fall’s vaccine really is, it is how safe people perceive it to be.

 

Public health officials are facing an uphill battle to convince people that the vaccine is safe, particularly when they know that a certain number of vaccine recipients are going to suffer adverse health events in the days and weeks following receiving their shot.


And most of those will have absolutely nothing to do with the vaccine.

 

Every day in the United States thousands of people die, or suffer a serious health event, whether they’ve recently been vaccinated or not. 

 

In my blog Public Health’s Biggest Pandemic Challenge, I point out that 1 in 7 pregnancies end in miscarriage.  With a push to vaccinate pregnant women, thousands of expectant mothers who get the shot this fall will undoubtedly miscarry.  

 

And many will blame the vaccine, even though the overwhelming odds are that they would have lost their child anyway.  Nearly 1 million American women do every year.

 

After the 1976 debacle we worry a good deal about GBS (Guillain-Barre Syndrome), but the background rate of the disease is such that we see nearly 5,600 cases here in the United States each year.

 

If we vaccinate half the US population over the next few months, we could realistically expect nearly 3,000 of those vaccine recipients to develop GBS over the next 12 months just based on the background rate of the disease. 

 backgroundrate

 

As you can see, the background rates of these diseases are always in motion.  It is inevitable that a certain number of people who are recently vaccinated will experience a health crisis or event. 


The difficulty will be in determining if the vaccine contributed in any way to their condition.  The government has a number of programs in place to look for adverse reactions, such as VAERS and the VSD project, but these will take time. 

 

And any causal link to the vaccine won’t be known until millions of shots have been given out.   Just as it is every year with the flu vaccine.

 

Meanwhile, some members of the press will no doubt be highlighting the number of heart attacks, miscarriages, and cases of GBS that occur in those who had taken the shot.  And the public’s concerns over safety will likely increase.

 

In 1976, the pandemic vaccination program was derailed early on by bad publicity.   Since the pandemic never appeared, that actually turned out to be a good thing.

 

But today we face a situation where the virus is already here, and for a small percentage of the population, could prove deadly.  A safe and effective vaccine could end up saving a lot of lives.  


How well public health officials are going to be able to counter anti-vaccination messages, along with public complacency over what has been billed for months as a `mild’ virus, and the all-but-inevitable bad press that the vaccine will engender once it starts going into the arms of the public, remains to be seen.


Next to actually producing and rolling out a safe and effective vaccine, convincing a skeptical and risk adverse public to accept this shot is likely to be public health’s toughest challenge.