Monday, November 4, 2013

Wayne Peal: A year into outbreak, who's looking out for patients?

There are dozens of fungal meningitis patients in Livingston County, hundreds more all across the nation, and over the past year, my colleagues and I have interviewed a fair number of them.
Their comments have more or less included the same question: Who is looking out for us?

I’d second that.

One year into the biggest outbreak of its kind in U.S. history who, indeed, is looking out for us?
If you can tell me with any certainty that you’ve never been prescribed medicine created at a compounding pharmacy, that’s great. But it’s not something I can say.

All these patients wanted to do was to get a little relief from their pain. So, unquestioningly, they took steroid shots that turned out to be contaminated. Not only didn’t it ease their pain, it made it worse — physically, mentally and financially.

We’ve heard from people who can no longer work, who can no longer even walk up stairs.
One year later, some 751 infections have been reported in 20 states, resulting in 64 deaths. Nineteen of those who died were from Michigan.

There’s been periodic flurries of media interest, medical reports and congressional hearings.
Today, the situation stands pretty much as it was one year ago.

Compounding pharmacies, like the one linked to the outbreak, still are mostly exempt from federal Food and Drug Administration oversight.

The philosophy is as follows: Compounding pharmacies, which blend drugs into new types of medicine, are primarily single-batch producers, too small to merit interest from the FDA.
Maybe that was once the case. But, as we now know, the New England Compounding Center produced thousands of batches of its steroid compound.

In recent weeks, a South Lyon-based compounding pharmacy, citing “an abundance of caution,” issued a voluntary recall of 98 medications — some for humans, some for pets — after traces of contamination were discovered in a product sent to a Michigan hospital.

That case isn’t equivalent with that of the NECC, or the fungal meningitis outbreak.

But it shows we’re still at risk.

That must end.

Congress must act, now, to give the FDA new authority over compounding pharmacies, at least those that produce multiple batches of medicine and ship it across state lines. It’s authority the FDA sought long before the outbreak occurred.

Just last week, the FDA assumed greater regulatory powers — over pet food.

In fairness, even the largest compounding pharmacies do far more good than harm. They are a necessary part of our nation’s health-care system.

But, when they err, the problems can be catastrophic.

If you don’t believe it, just talk to the people we’ve talked to.

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