Lethal medicine linked to meningitis outbreak

George Cary: By the time the hospital determined that she had suffered a stroke it was too late.

Karina Baxter: Same here.

George Cary: She died five days later.

Lilian Cary died before doctors figured out what was happening. So, while she was in the hospital, her husband George decided to do something about a nagging pain in his back. He went to the same clinic she had. And now the fungus is in him too.

Scott Pelley: What has the treatment been like?

George Cary: You're not able to function. You're not able to concentrate. You, you, the staff called us the walking zombies.

On September 26th, after patients started dying, state officials came to inspect NECC.

Scott Pelley: What happened that day?

Joe Connolly: We were told that we're being inspected, so, "Everybody stop what you're doing, start cleaning."

Scott Pelley: So you started cleaning the clean room?

Joe Connolly: Yeah.

Scott Pelley: Now, at this point, there is a federal investigation underway.

Joe Connolly: I did-- we didn't know that.

Scott Pelley: You didn't know that, but the company knew that.

Joe Connolly: I would assume, yeah.

Scott Pelley: A prosecutor investigating this case might consider that to be obstruction of justice.

Joe Connolly: I would very much agree.

Scott Pelley: The evidence was getting cleaned up.

Joe Connolly: It seemed like it.

Despite the cleanup, the FDA tested 50 left over vials of methylprednisolone and all were contaminated. They noted the intake for NECC's ventilation was 100 feet from the recycling plant.

Barry Cadden, New England Compounding's founder was subpoenaed by Congress.

[Barry Cadden: I respectfully decline to answer on the basis of my constitutional rights and privileges, including the Fifth Amendment to the United States Constitution.]

Scott Pelley: I wonder what you would say to him today.

Patient: I'd hope it'd be through bars. Whatever I said to him I hope it'd be through bars.

After this interview, Willard Mazure lost feeling in both legs. He's back in the hospital and so is George Cary. Margaret Hamburg, commissioner of the FDA now wants Congress to return authority over compounding pharmacies to her agency.

Margaret Hamburg: We need clear, strong, consistent federal standards that will be applied across the board, all 50 states. We need to be able to go in and inspect these facilities and get access to all of the information that we need.

Scott Pelley: What are the chances of this happening again?

Margaret Hamburg: I'm sad to say that if we do not put in place the comprehensive legislation that really defines roles and responsibilities, we will have other similar problems.

Barry Cadden and others are targets of a criminal investigation. Cadden declined to be interviewed. His lawyer told us that Cadden is saddened by all of this, but does not know how the drug was contaminated. NECC has gone into bankruptcy and we noticed in the court papers that Cadden and his partners withdrew $16 million from the company over the last year, some of it as people were beginning to die.

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[saasy4mom]

I feel sympathize for people that haven't not a clue what has happened to their helth and their life. It is troubling that people still don't know that they have poisoned with the corrupt drugs and are just now asking pertinent questions. If you were basically healthy, with the exception of chronic physical pain, took steroid injections and then became mysteriously systematically ill, very likely your injections were tainted with the fungus. Call a lawyer soon and tell the family members of your deceased friends to call a lawyer. You need help because it sounds as if people are hiding the truth. Get help now.

[jwmart1]

How can we find out what steroids were used; By their name.
I was on a heavy regime of steroids for roughly a week, while hospitalized. On 7th day (or night), I suffered a stroke. I personally know two others also affected. One also had a stroke and the other severe lung fungus and damage.
Any information would be most appreciated.

[ksok1]

Here is the recalled lots and the facilities using the steroid injections.
http://www.cdc.gov/hai/outbreaks/meningitis-facilities-map.html

[saasy4mom]

my address is [e-mail]

I can put you in contact with someone who will be very helpful to you!

[ArizonaBill]

Why didn't 60 Minutes interview someone from the state agency responsible for inspecting NECC? No one is questioning the state agency which failed so miserably in this case. Is 60 Minutes so incompentent they can't figure out what state agency was responsible or do they have an agenda in getting the FDA more control over the drug industry?

[Alexxxxx123]

Big Pharma has nothing to do with compounding.....Pharmacists compound. Groups such as the International Academy of Compounding Pharmacists, National Association of Community Pharmacists and the American Pharmacist Association are the groups lobbying against regulation of compounding stating that State Boards of Pharmacy are doing a good job....absolutely not true. Check out who sits on the state boards.

For the past 20 years, over and over, people have been harmed by companies that hide under this umbrella of compounding pharmacy. And the state boards issue fines......big deal. These groups even put together their own accreditation board and the guy who heads it up owned Triangle Pharmacy... the pharmacy that killed Shari Berg with a lidocaine cream that was made wrong!

People should only use compounded drugs as a very last resort AND the law should require every compounded product to be labeled...THIS IS NOT FDA APPROVED....a statement these organizations have fought being posted for years. Sadly, this is not about patients as the pharmacy groups will yell....it's about money......a lot of money.

[james6482]

Seriously Alex, get a clue. For the past 12 years, we have had say about 300 adverse events concerning compounded products. If you include the NECC debacle, call it about a thousand. Big Pharma estimates that about 2% of all prescriptions are compounds. Thats 2% of 4 billion prescriptions or about 80 million per year are compounded. . So the ratio here is about 80 adverse events per 80 million compounded rx's per year. That is an incredible safety record. Do you have any idea the estimated deaths resulting from drugs that big Pharma makes? The ratio in much much higher The vast majority of sterile compounding pharmacy's are compliant with the laws (USP ch 797). We have saved the day in various drug shortages and help patient's when the drug industry turns their back on patients because there is not enough money to be made on certain therapy's. NECC should have been shut down year's ago but instead of blaming the MASS pharmacy commission or the FDA, every is throwing ALL the rest of the sterile compounding pharmacy's under the bus. Remember, if compounding pharmacy goes away, patients WILL suffer.

[josephp5]

I want to say a word about Dr. David Kessler, the former head of the FDA. It is a rare person who forsakes a huge salary from his field (medicine) in order to serve as a low paid, under-respected bureaucrat, just because he knows that the position is far more important to the welfare of humanity. Dr. Kessler is such a person. If there were more people in government with his integrity we would be a much better country.

[eyeamnotalone]

This is another example of greed causing great harm. More FDA regs aren't necessarily the answer. There are contaminents in those drugs that are checked from prescribed drugs to OTC- recalls are common. Some intentional (the tylenol poisonings) to errors at manufacture. Flu vaccines have had issues. Now with required shots for hospital staffs so the institution doesn't lose federal dollars --well that may be yet another example of greed AND abuse of manufactured drugs in this country.

[PharmD99]

I am a compounding pharmacist and am saddened that patients are harmed by negligence. I am even more appalled by the deception and arrogance of NECC. I want to clarify some points from the story. Medications used by compounding pharmacies ARE FDA approved medications. If two medications are combined this is what the FDA considers unapproved. I also want the public to know the FDA is not the agency it used to be. Most if not all of are raw pharmaceutical ingredients are made in China or India and the FDA is supposed to inspect those facilities but they do not have the finances or man power to do so. Less than 2% of the raw drug that is imported is inspected by the FDA.
Compounding pharmacies are regulated by both FDA and state board of pharmacy regulations. We are licensed and are obligated to follow those regulations. Compounding pharmacies can not make copies of commercially available products except on a patient by patient basis. Examples being a patient may be allergic to a non active ingredient in the product, in this case we can compound that product for that individual patient. We can also supply a limited number of compounded medications for physicians to use in their office practice. The quantity supplied for office use is stated to be less than 5% of what is sent into that state. This is one of those state board of pharmacy regulations. No compounding pharmacy needs a sales force, if they have one they are manufacturing in hopes of getting orders. Pharmacist are licensed professionals and as such each year when we renew our license we are agreeing to uphold those laws and regulations. As we are painfully aware not all of us do so. NECC is but one of many large compounders that act as a manufacturer. I worked for one in Florida and left after a few months because regulations were being ignored.
For the consumer of compounded medications here is the skinny.
Doctors CAN NOT resell compounded medications to patients per state and FDA regulations. If a physician is selling you a compounded medication you are overpaying. Dealing with the pharmacy directly will save you money.
A doctor can't require you to use a particular pharmacy to obtain your compounded medication. It is your prescription and your choice.
A word about veterinary compounds. Many Vets ask that componding pharmacies copy commercially available products because they use it as an income source, you are paying more to the vet.

[glorihat]

Yay, 60 mins. Big pharm rules again. How many FDA approved drugs have caused harm/death? Shame on you.

[ClaudeSlagenhop]

Please do a piece sometime on how FDA regulation has killed hundreds of thousands of people by holding up drugs that have been approved in other countries but because of the horrible bureaucracy have not been approved in the USA.

[josephp5]

I think that piece only resides in the fantasy world of Republicans and their big Pharma contributors.

[WhoDisIz]

Where can I find a list of the states that this was shipped to?