Monday, November 4, 2013

More will suffer without action on compounding

It’s been exactly one year since my teenage son contracted fungal meningitis from a tainted steroid injection produced by the New England Compounding Center. We had been notified that he could become sick because he received one of the pharmacy’s suspect injections from Insight Imaging in Roanoke to treat back pain. After several weeks passed without any symptoms, we thought we were in the clear. But on Oct. 28, 2012, the relief we had been feeling quickly turned to terror.

Zac was healthy and strong up to that day. Two days earlier, he had played one of the best football games of his high school career. But by the morning of Oct. 28, he was completely incapacitated by severe pain and high fever caused by the infection. He spent weeks in the hospital and missed several months of school, including the rest of the football and basketball seasons. While he was in the hospital, the infection so inflamed his optic nerves that he could not tolerate even the smallest amount of light. His room had to be completely dark, and he had to wear a blindfold, while the nurses used flashlights to enter his room.

Even after Zac was released from the hospital, he had weekly blood draws for three months while he continued to take powerful antifungal medicine. He has undergone 11 excruciatingly painful spinal taps. And we’re still not sure if we’re out of the woods. The doctors tell us they can’t say if the infection will come back or whether my young son’s apparent cure will last.

And so our struggle continues, as do the struggles of more than 700 others across the country who suffer with the physical, emotional and financial effects of this preventable outbreak. We feel immensely fortunate that Zac survived — too many lost their lives because of this senseless negligence. Yet nothing has been done to prevent a future tragedy.

The problem stems from a lack of clarity about who is responsible for policing compounding pharmacies, like the New England center and scores of others across the country. Pharmacy practice oversight falls under state control, while the safety and effectiveness of the drug supply is subject to oversight by the U.S. Food and Drug Administration. Compounding pharmacies dabble in each of these regulatory environments. Some say the FDA had the authority to step in and prevent the problems at the New England center; others say the agency’s hands were tied. But most agree that greater clarity on this matter — and action — is needed.

The good news is that thoughtful bipartisan legislation is advancing in Congress. In late September, the U.S. House of Representatives approved the Drug Quality and Security Act with overwhelming bipartisan support. The U.S. Senate now has the opportunity to act on this legislation, which provides for the legitimate practice of compounding — on an individual basis and with valid prescriptions from a physician — while cracking down on those often unscrupulous manufacturers who are masquerading as pharmacies to avoid scrutiny of their facilities and processes.

It also establishes clear specifications about who is responsible for identifying and taking actions to stop unsafe and illegal practices. This legislation needs to become law quickly — sadly, the tainted steroid injection nightmare that families like ours endured is not an isolated event.
Several years ago, the FDA and Florida health officials determined that a Hollywood, Fla., pharmacy had not followed the proper repackaging procedures when compounding Avastin for use in the eye, causing some patients to lose all remaining vision in the eye that was treated. More recently, two separate families filed suits in U.S. District Court in Nevada charging that a heart medication, also produced by the New England pharmacy, was responsible for the deaths of two young children undergoing heart surgery. How many more must face serious injury or death before something is done?

On behalf of my son, the youngest known victim of the injectable steroid tragedy, and the many others who continue to suffer from lives torn apart, endless and painful treatments, and lost livelihoods without hope of compensation or legal recourse, I implore lawmakers to take action on this important issue. Congress, as well as the General Assembly in Virginia, must put political posturing aside and pass common-sense solutions or people will continue to suffer. Every day we delay could mean greater harm done and more lives needlessly lost.

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