TOPICS > Health

In One Family’s Tragic Meningitis Story, Support for More Policing of Pharmacies

November 14, 2012 at 12:00 AM EST
Diana Reed, a 56-year-old Tennessee woman who was caretaker for her husband Wayne, died suddenly of fungal meningitis after receiving tainted steroids for neck pain. Cases like Reed's have put regulatory oversight on compounding pharmacies into question, with the FDA saying it needs more authority to help keep consumers safe.
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GWEN IFILL: Finally tonight: the toll of the meningitis outbreak; 32 people have died so far, and more than 400 others have become ill; 14,000 people may have been exposed to the drugs injected to ease back pain.

The state of Tennessee was especially hard-hit, with 13 deaths.

NewsHour health correspondent Betty Ann Bowser has a look at the personal impact there and the bigger questions surrounding this story.

BETTY ANN BOWSER: Diana and Wayne Reed did everything together. They ate meals together, vacationed together, danced together, and of course, raised their two sons, Erik and Kevin, together.

So, 27 years ago, when Wayne was diagnosed with amyotrophic lateral sclerosis, known as ALS, or Lou Gehrig’s disease, they fought that together, too. Diana was Wayne’s primary caregiver, so it came as a complete shock when the 56-year-old died suddenly on Oct. 3 from fungal meningitis.

It was an even bigger shock when Wayne and her friends were told Diana had been injected with a contaminated steroid medication made at a compounding pharmacy in Massachusetts. Wayne has the same rare slow growing form of ALS as physicist Stephen Hawking, so he has trouble speaking. But his mind remains sharp and has not been affected.

WAYNE REED: I can’t take care of myself without a little help.

BETTY ANN BOWSER: So, it’s one thing to have someone to take care of you; it’s something else when that person is your best friend and you just really miss them? And that’s the hard part?

WAYNE REED: Yes. Right.

BETTY ANN BOWSER: Pat Ward was Diana Reed’s best friend.

PAT WARD, friend of Diana Reed: You can’t really think of one of them without the other. She was just such a vibrant person who lit up the room. There’s just a great big hole missing.

BETTY ANN BOWSER: In the months before her untimely death, Diana had been having severe neck pain. She had recently lost her job and was trying to use her health insurance while she still had coverage.

Hoping to relieve the pain, Diana arranged to get a series of three epidural steroid injections here at an outpatient clinic at St. ThomasHospital in Nashville. But less than 24 hours after the last injection on September 18, she got a headache that wouldn’t go away.

PAT WARD: She was in a lot of pain.

BETTY ANN BOWSER: And it was just nothing would give her any relief?

WAYNE REED: No.

PAT WARD: No, they would give her pain medicine and it would dull it, but the pain never totally went away.

BETTY ANN BOWSER: So you went to the E.R.?

PAT WARD: Right.

BETTY ANN BOWSER: Over the next few days in the hospital, Diana got progressively worse.

PAT WARD: She was slurring her words and having trouble getting things out that she wanted to say.

WAYNE REED: Having a hard time between reality and dream world.

PAT WARD: Yes. She told me she had a dream about me. And she asked me if it really — if that really happened.

BETTY ANN BOWSER: Diana slipped into a coma. When an MRI showed she had extensive permanent brain damage and couldn’t recover, Wayne had Diana taken off life support. She died two days later.

Since Diana’s death, hundreds of volunteers from their church have taken over Wayne’s 24-hour-a-day care. Someone comes over several times a day to give Sherman, the family dog, a good walk.

Volunteers like Marlene Butler make sure all of Wayne’s meals are covered. And Mandy Stickel, the daughter of Wayne’s college roommate, comes every day to help with lunch and phone calls.

WOMAN: He’s interested in getting his newspaper dropped off at his back door.

BETTY ANN BOWSER: Wayne Reed and Pat Ward say Diana would want them to move on now with their lives, but it’s hard.

WAYNE REED: I still think she will walk through that door. We were together 40 years.

PAT WARD: She lit up a room. When she walked in, you knew she was there. When she left the room, you knew she was gone. She was funny. She had a great sense of humor. She had a great sense of style.

And yet she knew, because of the things that she had gone through in this life, certainly with Wayne’s illness and other things that she had gone through, she also knew about pain.

WAYNE REED: I’m not angry. I have never been angry. I’m sad.

BETTY ANN BOWSER: What is the thing you miss the most?

WAYNE REED: Her smile.

BETTY ANN BOWSER: The first case of fungal meningitis was identified here in a microbiology lab at the VanderbiltUniversityMedicalCenter in September after a previously healthy man in his 50s became ill and died.

The cause was traced to tainted steroid medication that was made at the New EnglandCompoundingCenter in Framingham, Massachusetts. It’s the same place that made the drugs Diana Reed was given. The pharmacy has since been shut down and its products recalled; 1,100 miles away in Nashville, where hundreds of vials of the tainted steroid medication had been shipped, public health officials knew they had a crisis in their own backyard.

DR. DAVID REAGAN, Tennessee Department of Health: One thousand and nine people potentially received a tainted medication.

BETTY ANN BOWSER: Have you tracked every one of them down?

DAVID REAGAN: We tracked every one of them down.

BETTY ANN BOWSER: Dr. David Reagan is the chief medical officer for the Tennessee Department of Health.

DAVID REAGAN: We went door to door if we had to go door to door, and we worked with — this was complicated because the patients may have received their injections here, but they were getting symptoms in at least eight other states. And three of them began to get symptoms while they were outside the continental United States.

We had to use a lot of creative ways to find people. It was — certainly, we looked at everything we could, including Facebook, to try to get to folks.

BETTY ANN BOWSER: The Health Department quickly mobilized their operations center to reach out to all the patients they thought might have been exposed, but it was still a race against time.

People who were being diagnosed late in the game were the ones who were dying.

DAVID REAGAN: The earlier you treat, the easier it is to treat. Getting medication into the central nervous system is tricky. Not every medication gets in there. And so you have really got to be very careful about what you give and that you’re giving it in appropriate quantities.

BETTY ANN BOWSER: Much of the attention now is also turning to the big question of why the pharmacy wasn’t more closely regulated.

Compounding pharmacies mix ingredients to make specialized drugs that are not available and sold on the general pharmaceutical market. The federal Food and Drug Administration inspected the New EnglandCompoundingCenter after the outbreak. It found many other vials like these that were contaminated with a black fungus.

DR. WILLIAM SCHAFFNER, VanderbiltUniversity: I actually said to myself, this is ghastly.

BETTY ANN BOWSER: Dr. William Schaffner Chairs the Department of Preventive Medicine at Vanderbilt. He read the recent FDA report.

WILLIAM SCHAFFNER: There seemed to be just a general level of slovenliness in the institution. It was dirty. It wasn’t not meticulously cared for. An institution that prepares sterile medication has got to be clean. It’s got to be cleaner than hen’s teeth, as they say. And this institution simply wasn’t.

BETTY ANN BOWSER: Today, on Capitol Hill, members of the House Energy and Commerce Committee had their first chance to question the FDA. Lawmakers wanted to know how the FDA knew there were problems at the pharmacy as early as 2002, but took no action. The agency later issued a warning letter in 2006, but no tougher action was taken then.

REP. CLIFF STEARNS, R-Fla.: After a tragedy like this, the first question we all ask, could this have been prevented? After an examination of documents produced by the Massachusetts Board of Pharmacy and the U.S. Food and Drug Administration, the answer appears to be yes.

BETTY ANN BOWSER: Some experts contend the FDA already has the authority to regulate large compounding pharmacies.

But in her first public remarks today, FDA Commissioner Dr. Peggy Hamburg said her agency needs more power. Dr. Hamburg proposed a two-tier system where smaller and more traditional pharmacies would be regulated by the states. Larger pharmacies of all kinds would be overseen by the FDA.

MARGARET HAMBURG, Food and Drug Administration: The fact that we have unclear, limited and contested authorities and ambiguities in the law, and a crazy quilt of legal authority, has required us to be very reactive responding to those serious public health threats and selective.

And, of course, every effort is resource-intensive.

BETTY ANN BOWSER: Barry Cadden, the president of the New EnglandCompoundingCenter, refused to answer questions.

BARRY CADDEN, President, New EnglandCompoundingCenter: Mr. Chairman, on advice of counsel, I respectfully decline to answer on the basis of my constitutional rights and privileges, including the Fifth Amendment.

BETTY ANN BOWSER: Mark Binkley, a pharmacist at the Health and Wellness Compounding Pharmacy in Nashville, believes giving states more power to regulate is the answer. His company has been inspected by the FDA in the past, but it’s not involved in the current controversy.

MARK BINKLEY, Health and Wellness Compounding Pharmacy: We need a higher level of inspection. We need well-funded, well-trained state-level inspectors that can come in and be sure we’re doing what we say we’re doing.

BETTY ANN BOWSER: The questions are sure to keep coming. Tomorrow, the FDA chief will face another hearing in the Senate.

JUDY WOODRUFF: You can track the cases of fungal meningitis on our Web site using our interactive map. Also there, read the CDC’s top 10 things you need to know about meningitis. And if you still have questions, join our live chat with the CDC tomorrow. The details are on our Health page.