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Vijay Sikand

๐Ÿ‘ค Speaker
199 total appearances

Appearances Over Time

Podcast Appearances

Unexplainable
The lost Lyme vaccine

As a matter of fact, it got so busy, I had to stop my private practice completely.

Unexplainable
The lost Lyme vaccine

I love that question because being a double-blind study, I had no idea whether patients were receiving vaccine or placebo.

Unexplainable
The lost Lyme vaccine

And as you can imagine, during the course of those few years where we were blinded, I had patients out of 1,200 coming down with all kinds of things.

Unexplainable
The lost Lyme vaccine

whether it's heart attacks, strokes, things that people have in the normal course of their lives when you're adults.

Unexplainable
The lost Lyme vaccine

And I always wondered, gosh, I hope the vaccine's not causing it.

Unexplainable
The lost Lyme vaccine

But fortunately, we had what's called a data safety monitoring board, independent board, which was not blinded.

Unexplainable
The lost Lyme vaccine

So they were able to look at all these things that were happening that were sort of worrying me and other investigators and know whether there was a signal or not that the vaccine was involved.

Unexplainable
The lost Lyme vaccine

So fortunately, this data safety monitoring board never called and said, hey, stop the study, which I wondered, gosh, I hope I'm not doing this.

Unexplainable
The lost Lyme vaccine

As you can imagine, the very vast amount of data that were accumulated from all the sites around the country had to be collated, analyzed.

Unexplainable
The lost Lyme vaccine

sliced and diced by statisticians, run by data safety review boards where they're looking at adverse effects that patients had reported throughout the study to see whether they may or may not have been related to the vaccine.

Unexplainable
The lost Lyme vaccine

But patients actually became impatient in a way, no pun intended, because they wanted to know.

Unexplainable
The lost Lyme vaccine

And of course, patients, we didn't unblind the study until after it was over.

Unexplainable
The lost Lyme vaccine

So patients were wondering, did I get the real thing or not?

Unexplainable
The lost Lyme vaccine

And then, of course, it was a game.

Unexplainable
The lost Lyme vaccine

There were people who'd say, I know I got the real thing because I felt, mmm, after my arm really ached or I had this achiness the next day or I had this little temperature, so I think I got the real thing.

Unexplainable
The lost Lyme vaccine

But it'd be amazing how often they were wrong.

Unexplainable
The lost Lyme vaccine

So it prevented roughly 80% of cases of Lyme disease that would have occurred in people who were vaccinated compared to people who weren't.

Unexplainable
The lost Lyme vaccine

Being the physician on the ground there in Lyme, Connecticut, my job was to tell these folks from the FDA why we even needed a vaccine for Lyme disease.

Unexplainable
The lost Lyme vaccine

It's often difficult to diagnose Lyme.

Unexplainable
The lost Lyme vaccine

It may be difficult to treat.