The following script is from "Lethal Medicine" which aired on March 10, 2013, and was rebroadcast on Aug. 11, 2013. Scott Pelley is the correspondent. Michael Radutzky, Oriana Zill de Granados and Michael Rey, producers.
Last fall, 17,000 vials of a steroid were shipped to clinics and hospitals in 23 states. The drug had to be sterile because patients would have it injected into their joints or into their spines to relieve chronic pain. What happened next is the worst pharmaceutical disaster in decades.
The steroid was contaminated with fungus. More than 50 people have died, and around 700 are being treated for persistent fungal infections. The tragedy has exposed a failure in drug safety. And, in a moment, you will hear the commissioner of the FDA acknowledge that she can no longer guarantee the safety of many high risk drugs.
The steroid was produced by New England Compounding Center and in the six months since the first deaths, no one at New England Compounding had ever revealed what happened. But they did when we first aired this story last March. As for the victims, this has been an unrelenting horror after just one injection of lethal medicine.
Julie Otto: I've been in the hospital seven times, total of 75 days. I've missed Thanksgiving and Christmas and my son's birthday.
Julie Otto is one of 13 injured patients who met us at St. Joseph Mercy Hospital outside Detroit.
Willard Mazure: I'm on 60 milligrams of morphine a day with no cure in sight. There is no cure in sight for me.
Willard Mazure's morphine is to kill the pain from the fungal infection. We asked the patients to sit down in the first two rows and many of them brought family to the auditorium. Michigan is a hotspot for the toxic steroid, one of 23 states that received the drug from Massachusetts. St. Joseph Mercy has treated 189 patients -- all of whom endure brutal anti-fungal drugs.
Willard Mazure: The medicine is just unbearable. You know, they talk about cancer treatments, and I'm sure they're unbearable too. But this is some unbearable stuff.
This is the fungus. It is a sample that has been grown from the spinal fluid of a patient. The fungus is a form of mold that attacks bone and nerves. The patients who had it injected in the spine have an infection called meningitis which can also reach the brain.
Scott Pelley: Have the doctors told any of you that the fungus is gone and you never have to worry about it again?
Voices: No. Absolutely not. No.
The steroid, methylprednisolone acetate, made by New England Compounding Center, known as NECC, came from this industrial park near Boston which houses the pharmacy and an outfit that recycles construction debris -- both owned by the family of Barry Cadden, a pharmacist, and president of NECC.
Cadden's New England Compounding Center was what's known as a compounding pharmacy. By law, compounding pharmacies are not allowed to manufacture pharmaceuticals for the mass market. That would require the oversight of the FDA. Instead, states license compounding pharmacies to make drugs for individuals. For example, a doctor might order a liquid form of a medication for a patient who can't swallow a pill. Compounding pharmacies are bound by one rule: they must have a prescription for each individual patient.
But NECC was shipping tens of thousands of vials from its lab called Clean Room One. Investigators shot video inside NECC. This is the first time the public has seen it. And this is the first interview with a technician from Clean Room One.
Joe Connolly: The underlying factor is that the company got greedy and overextended and we got sloppy, and something happened.
Joe Connolly started in Clean Room One in 2009. He remembers, in 2011, a salesman came by with a boast and a warning.
Joe Connolly: He was walking through and says, "Oh, I got-- I got a bunch of stuff coming for you guys. You guys are gonna be busy. You're gonna-- I'm gonna keep you guys movin'." And that just meant compound it, process it, get it out the door.
Connolly says, over months, the lab was overwhelmed with orders. Output of drugs that he made increased by a factor of 1,000.
continue to read here
Last fall, 17,000 vials of a steroid were shipped to clinics and hospitals in 23 states. The drug had to be sterile because patients would have it injected into their joints or into their spines to relieve chronic pain. What happened next is the worst pharmaceutical disaster in decades.
The steroid was contaminated with fungus. More than 50 people have died, and around 700 are being treated for persistent fungal infections. The tragedy has exposed a failure in drug safety. And, in a moment, you will hear the commissioner of the FDA acknowledge that she can no longer guarantee the safety of many high risk drugs.
The steroid was produced by New England Compounding Center and in the six months since the first deaths, no one at New England Compounding had ever revealed what happened. But they did when we first aired this story last March. As for the victims, this has been an unrelenting horror after just one injection of lethal medicine.
Julie Otto: I've been in the hospital seven times, total of 75 days. I've missed Thanksgiving and Christmas and my son's birthday.
Julie Otto is one of 13 injured patients who met us at St. Joseph Mercy Hospital outside Detroit.
Willard Mazure: I'm on 60 milligrams of morphine a day with no cure in sight. There is no cure in sight for me.
Willard Mazure's morphine is to kill the pain from the fungal infection. We asked the patients to sit down in the first two rows and many of them brought family to the auditorium. Michigan is a hotspot for the toxic steroid, one of 23 states that received the drug from Massachusetts. St. Joseph Mercy has treated 189 patients -- all of whom endure brutal anti-fungal drugs.
Willard Mazure: The medicine is just unbearable. You know, they talk about cancer treatments, and I'm sure they're unbearable too. But this is some unbearable stuff.
This is the fungus. It is a sample that has been grown from the spinal fluid of a patient. The fungus is a form of mold that attacks bone and nerves. The patients who had it injected in the spine have an infection called meningitis which can also reach the brain.
Scott Pelley: Have the doctors told any of you that the fungus is gone and you never have to worry about it again?
Voices: No. Absolutely not. No.
The steroid, methylprednisolone acetate, made by New England Compounding Center, known as NECC, came from this industrial park near Boston which houses the pharmacy and an outfit that recycles construction debris -- both owned by the family of Barry Cadden, a pharmacist, and president of NECC.
Cadden's New England Compounding Center was what's known as a compounding pharmacy. By law, compounding pharmacies are not allowed to manufacture pharmaceuticals for the mass market. That would require the oversight of the FDA. Instead, states license compounding pharmacies to make drugs for individuals. For example, a doctor might order a liquid form of a medication for a patient who can't swallow a pill. Compounding pharmacies are bound by one rule: they must have a prescription for each individual patient.
But NECC was shipping tens of thousands of vials from its lab called Clean Room One. Investigators shot video inside NECC. This is the first time the public has seen it. And this is the first interview with a technician from Clean Room One.
Joe Connolly: The underlying factor is that the company got greedy and overextended and we got sloppy, and something happened.
Joe Connolly started in Clean Room One in 2009. He remembers, in 2011, a salesman came by with a boast and a warning.
Joe Connolly: He was walking through and says, "Oh, I got-- I got a bunch of stuff coming for you guys. You guys are gonna be busy. You're gonna-- I'm gonna keep you guys movin'." And that just meant compound it, process it, get it out the door.
Connolly says, over months, the lab was overwhelmed with orders. Output of drugs that he made increased by a factor of 1,000.
continue to read here