Did Michigan drop the ball in protecting residents from the meningitis outbreak?
11:10 PM, Feb 27, 2013
11:40 PM, Feb 27, 2013
(WXYZ) - Did Michigan fail to protect its residents from that deadly meningitis outbreak that has killed 13 people here and sickened hundreds of others? Action News has learned the state knew little about the New England Compounding Center, and that it's common state regulators don't check into companies selling drugs here.
The Heavy Toll
Michigan has been hardest hit by this outbreak with four clinics around the state receiving the tainted shots. 13 people have died, 64 people have been diagnosed with meningitis and close to a couple hundred others are now battling fungal infections at the source of their injections.
Rhonda Hall from Brighton is one of them. She received a tainted shot for back pain made by the New England Compounding Center in Massachusetts. But instead of relief, she got more pain and some 40 days in the hospital over the last few months. This 50 year old has always been an active mother of five. And as a grandma, she's treasured her days babysitting her grandchildren, but now…
"I'm lucky if I can get out of bed. My husband just said to me, I've never seen you stay home in bed, for three days and not even move."
When I went to Washington to cover the meningitis hearings, NECC owner Barry Cadden wouldn't answer my questions, or those of the Congressional panel, pleading his 5
th Amendment rights.
It was clear during those hearing that there were a number of regulatory missteps that helped contribute to this tragedy.
Our Congressman grilled both the FDA and Massachusetts Public Health Department for not taking stronger action against NECC, despite a dozen complaints about the company's practices over a decade.
What Did Michigan Know?
But what about Michigan? The pharmacy was licensed to do business here, but the state doesn't inspect out-of-state pharmacies. They depend on the home state to do that. So what did Michigan really know about NECC? Action News did some digging, and what we found was troubling.
The company was first licensed in Michigan in 2004. By that time, the pharmacy and co-owner Barry Cadden had already been under review. According to a Congressional report, in early 2002 the FDA cited the company for "sterility issues…" and "emphasized the potential for serious public health consequences if NECC's compounding practices, in particular those relating to sterile products... are not improved". In 2003 Massachusetts filed formal complaints against NECC & Mr. Cadden "based on failure to adhere to standards of practice for compounding prescriptions."
But nowhere on the initial state license application in Michigan were there questions about complaints or ongoing investigations, only if a pharmacist's license had been limited, suspended or revoked.
Michigan granted the license.
Months later, Massachusetts issued three advisory letters to the company based on different complaints and in 2006 the NECC entered into a consent agreement with the board. It called for probation if the company didn't implement some safety recommendations. They did.
That same year Michigan renewed NECC's license. What did the state know then? Based on the renewal process, nothing. All that was required for NECC's to renew their license every two years was 150 dollars. No questions asked.
Despite repeated requests, state licensing officials refused to do an on-camera interview. They did send emails, telling Action News, "if there are complaints on file with an out-of-state pharmacy, it is in this instance, the Sate of Massachusetts obligation to report any complaint/sanction to the National Practitioner's Data Bank." When we asked if the state checks the Data Bank as part of the licensing process, the answer was no.
They tell Action News that three or four years ago, inspectors began check with the home state licensing agency to check out an out-of-pharmacy when it applied for a Michigan license. But before that, there was a "severe shortage of inspectors," and that didn't always happen.
They also add "in light of the NECC case, we will add questions about disciplinary actions to the (pharmacy) renewals in June."
Since this outbreak, the National Association of Boards of Pharmacy has begun an inspection program of compounding pharmacies licensed to do business in many states, and they'll share those results with state pharmacy boards. Clearly the belief now is the more information shared the better to prevent another tragedy like this one.
Too Late For Victims
It's a small step for Rhonda and hundreds of others hurting, and living with the pain of uncertainty.
"It's horrible to think it, and to even say it, but how long will I be alive, because we don't know.