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Susan Walsh / AP
Barry Cadden, president and co-owner of the New England Compounding Center, shown being sworn at a House Energy and Commerce oversight subcommittee hearing on Nov. 14, took the fifth and refused to testify.
The owner of a pharmacy at the center of an outbreak of fungal meningitis caused by contaminated pain drugs that have killed 32 people and made 461 people sick refused to testify at a packed hearing on Wednesday, and managed to avoid facing the family of his first victim.
Barry Cadden, president, co-owner and director of pharmacy for the New England Compounding Center, remained in a separate room with his lawyers while the wife of his first victim testified, then managed to avoid her in the hallway as she left the committee room. He took the fifth, invoking his constitutional rights not to testify -- even when asked whether he was the owner of the pharmacy.
Robbed of a chance to confront Cadden, members of the House Energy and Commerce oversight subcommittee instead spent hours berating the Food and Drug Administration. Despite their outrage over the growing toll from the outbreak, Republican members of the committee made it clear they are not ready to change any legislation just yet.
“We will be living with this nightmare for ages to come,” Joyce Lovelace of Albany, Ky., whose husband, Eddie, was the first person to die in the outbreak of fungal meningitis traced to the pharmacy, told the hearing.
“We now know that New England Compounding Pharmacy Inc. killed Eddie. I have lost my soul-mate and life’s partner with whom I worked side by side, day after day for more than 50 years,” said Lovelace, her voice cracking as she testified.
“It was not an easy death that we witnessed,” she added.
Lovelace said her husband, a 78-year-old judge, had been healthy and active before the spinal injections that killed him.
“I am asking this committee to find out how and why this happened and to plug the loopholes that allow these industries to escape meaningful inspection,” Lovelace said.
“I would ask that you inquire how such a product became so widely distributed. Why did so many medical providers purchase this product from unregulated or poorly regulated sources? Don’t just investigate. Instead, legislate and regulate.”
Cadden and his lawyers waited until Lovelace, who uses a wheelchair, was wheeled out of sight before they entered the committee room. He immediately made it clear he wouldn't testify. “Will you invoke your Fifth Amendment rights to all questions today?” Rep. Cliff Stearns, the Florida Republican who chairs the panel, asked Cadden. “Yes,” Cadden replied. Stearns then excused him.
Two top regulators then faced the frustrated panel for more than two hours.
If Congress doesn't strengthen legislation, another similar tragedy is inevitable, said FDA Commissioner Dr. Margaret Hamburg. "If we fail to act, this type of incident will happen again. It is a matter of when, not if," she said.
But committee members said the FDA and Massachusetts state regulators both knew as far back as 2002 that there were problems at the pharmacy, which distributed more than 17,000 doses from contaminated lots of steroids. Yet they failed to take forceful enough action, members said.
"This is a complete and utter failure on the part of your agency," Stearns told Hamburg.
Congress holds hearings on the multi-state outbreak of fungal meningitis traced to the New England Compounding Center. NBC's Erika Edwards reports.
“This one of the worst public health disasters ever caused by a contaminated drug in this country,” added Stearns, a Republican who chairs the oversight subcommittee.
“After a tragedy like this the first question we all ask is ‘Could this have been prevented?’” Stearns added. “After an examination of documents produced by the Massachusetts Board of Pharmacy and the U.S. Food and Drug Administration, the answer here appears to be, 'Yes.'”
An Energy and Commerce Committee report noted that the FDA and the Massachusetts state board of pharmacy both repeatedly visited NECC and found problems. But the strongest action that anyone took was a warning letter issued by FDA in 2006.
“You can take a regulator to a problem but you can’t make him regulate,” said Rep. Joe Barton of Texas. “It’s an absolute tragedy without any question that 32 people have died.”
Hamburg said the agency doesn’t have the authority to regulate compounding pharmacies in the way it does drug manufacturers. Legislation passed in 1997 was never enforced after the Supreme Court found part of it unconstitutional because it banned compounding pharmacies from advertising.
Compounding pharmacies are supposed to mix drugs to order based on specific prescriptions, and FDA and the Massachusetts regulators both knew that NECC was mass-producing and distributing drugs without individual prescriptions. Hamburg confirmed FDA teams found unsanitary conditions at NECC as far back as 2002.
“Throughout this time NECC has repeatedly disputed FDA’s jurisdiction over its facility,” she said. “The agency has struggled with how to chart an effective course to protect public health."
She said there are thousands more compounding pharmacies like NECC. "The industry has evolved well beyond the neighborhood pharmacy.”
Dr. Lauren Smith, who is interim commissioner of the Massachusetts Department of Public Health, said pharmacy board members who failed to act against NECC had been fired. James Coffey, director of the state’s pharmacy board, was dismissed earlier this month.
Smith also said the state had issued emergency regulations to deal with NECC and its sister pharmacy, Ameridose, which was licensed to mass-distribute medical supplies. Sterility problems were also found there, although no infections have been linked to that firm.
"As we work to raise standards in Massachusetts, we urge Congress to act to strengthen federal oversight. It is clear that the patchwork of disparate state regulations is not enough to keep the public safe,” Smith said.
California Democrat Henry Waxman urged his fellow panel members to get legislation written quickly, even though Congress is expected to do little between now and the end of the year, with the notable exception of budget negotiations. "Let's not lose sight of the wrongdoing as we go around blaming the regulators," he said. "I think we want to work during this lame duck session to pass bipartisan legislation," he added.
"We need to correct the law and we need to do it before we leave at the end of this year."
But Republicans said they were not convinced new legislation was really needed. Stearns said it was "incomprehensible" that the FDA didn't act even though it was aware that NECC was working on a scale far beyond its license in 2002.
"If they didn't exercise the authority they already had, new authority isn't going to solve the problem," said Michael Burgess, a Republican from Texas.
Waxman accused his colleagues of playing politics. "I have a feeling, Dr. Hamburg, that you are being picked on because you are a member of the Obama administration," he said.
Related stories:
Fungal meningitis victim: "It's tortuous"
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We need less regulation in business with the job creators....crickets
Exactly.
Over-regulation is an issue, yes. Regulation in general, though, is not. This is yet another example of why it's needed, along with the mortgage bust and a handful of other recent events. When you have a 100% open market you have a market that gets out of control and becomes dangerous.
And as far as regulations hurting 'job creators', I call BS. We have companies making millions, even billions of dollars laying people off because their personal income (not corporate, personal) is going down. News flash: if you're doing things properly, you may make less money, but you'll have less risk of lawsuits as well. Bad drugs, fingers in food, equipment failures, etc all cost companies money as well...
Problem is that every business or industry thinks they're over-regulated. I've heard busines owners complaining because they had to get a municipel business license.
Isn't funny to see republicans grandstanding about the need for more regulation. It's like they keep forgetting one of the idiotic talking points, that regulation is bad.
Sorry to those before me but I spent 40 years with individuals such as this and have seen horrors in the name of profit, my only surprise is that it has not occurred on this scale previously. This is a case were the FDA should have had complete control and the states should have none. It is much easier for 1 organization to maintain QC standards than 51 different groups. As a sub-note "hang the horses-ass that took the fifth"
** rwbplastic,
Please don't "hang the horses-ass that took the fifth"....
Publish his home address so we can all send him a "Strongly worded note of disapproval".
Of course we could also use the "State pharmacy board chief's " name and address also!
My first thought is, "what a rat." He looks well dressed, well fed, and..., well, smug.. Sounds like he is trying to cover his butt. I would never forgive myself if my negligence ended in someone's death, and I would want to talk about anything I could do to make what amends could be made.
If you have enough power to own a company, you had better be sure you possess the level of personal integrity it takes to be responsible for that company, especially in an area of work, like a pharmacy, that can kill people if something goes wrong. If you own a basketball court, it may not matter if your floors are sterile, but in a pharmacy, you had better be dang well sure that the place is CLEAN. Sounds like this guy was just out to make maximum bucks and was willing to put the safety of millions in jeopardy to do so. What a rat.
This guy is pleading the fifth. I don't think he'll have any problem denying responsibility. Anyone who lets his property go like that, ignoring any responsibility for cleanliness and industry regulations is a bastard, greedy business owner. Its that simple.
He apparently does not want to defend himself, his business, or his actions. So be it. Huge fine that puts him out of business, yank any professional license, and send his sorry arse to jail so he has at least 25 years to dwell on his need for greed.
I was on a number of medications that were making me more sick than my illness was, so after 5 years of misery I tried smoking pot one day and it alleviated all my symptoms and made my life wroth living again. Then last April someone smelled it coming out of my home and the next thing I knew there were 35 people, some wearing HAZMAT suits and others wearing riot gear, breaking my door down to get a a few 2' tall plants I had growing in the closet in the spare bedroom. They used the weight of the immature plants to charge me with felony possession and took my home from me, now they want to give me 3 to 5 years in prison. My health issues are back with a vengeance and I don't have insurance anymore to pay for the poison from the pharmacy.
What I am getting at is that this scum bag who killed 35 people and put hundreds in the hospital is going to get off with out losing his home or doing a day in jail, and I, who hurt no one and was only smoking so I didn't have to deal with a murderer like him, am going to jail for 3 to 5 years. THERE IS SOMETHING SERIOUSLY WRONG WITH OUR SYSTEM.
put him in jail on contempt charges till he decides to answer questions....instead he goes and it's buissness as usual.and the state knew 10yrs ago there were problems and did nothing?????? somebody got paid to look the other way....shameful
Constitutional rights don't suddenly disappear just because you've committed a crime, that's why you don't see summary executions in America.
James, I totally agree with you--the 5 th amendment was put there for a good reason, to protect the rights of all of us. That being said, I don't think that they will need this rat's testimony to convict him--the fact based concrete evidence appears to be overwhelming. I realize that this is not a trial, but a congressional hearing. It is probably the first step to a trial, though, and he will probably take the 5 th on that as well, if he doesn't abscond out of the country first.
Lisa is right. This isn't a trial, just a Congressional hearing. And most Congressional hearings are just show ... the people running them have often made up their minds, and they just want the publicity.
But as far as I know the 5th amendment doesn't apply in civil suits. I could be wrong, but I think a refusal to answer questions there can result in contempt charges.
James, you are correct. Sometimes it hurts to give others the rights they get along with the rest of us when they are so obviously in the wrong, but you have it right - in this case annoyingly right.
There's more than enough implicating him and his board members. Each of the cleanliness problems I've seen, taken individually, could be a poor manager or a rouge technician. Taken together, it points right at the top members of the company who were more concerned about the bottom line. Then there's operating beyond the company's license, which is not something any single department can do on its own. It takes a deliberate, coordinated, cross-company effort. Top managers give those orders.
He can plead the fifth til the day he dies, there's plenty of evidence against him.
@Severed .. I believe that you're right about testimony in civil suits not being covered by the 5th. However, the 5th could be taken if that testimony could result in criminal charges. That's why civil cases are usually conducted after completion of criminal investigations/trials.
This coward should rot in jail for the rest of his life for murdering the unfortunate victims callously and in cold blood. I want to erase that smirk off his face with a lawn mower.
Simply stated Cadden is a greedy Basturd! Inject him with " his own medicine" and let him wait and have the agony and fear of all these people .
@aswiftmom: Much as I agree that your idea would be satisfying, James is right in 3.1 above. (Unfortunately.)
Maybe I feel differently since I have a close friend who had those shots and is experiencing problems associated with Fungal Menengitis.
No you don't aswiftmom or you would have mentioned that first. Your a liar.
I want to know why a man who was healthy and active needed to have medicines injected into his spinal cord. I have to have spinal injections due to a birth defect that has been acting up since i got hit by a car, i dont get those injections until i cant walk and thats last resort, people take this stuff too lightly like its no big deal. I hate getting injections and avoid it if i can.
I hear a whif of "blame the victim"---------you must be a supporter of deregulation!!
Perhaps he was active BECAUSE of the injections? His medical diagnosis is none of our business.
simply put--my mom-in-law is a very active 85 year old who has to take a lot of pain medication to remain active. Her pain problem is also in her back, but is caused by osteoporosis having degenerated (and spontaneous fracture) about 5 or 6 of her vertebrae. Perhaps the man was active and otherwise healthy, but needed something to mitigate the pain so that he could remain active, thus being able to be more healthy. The big thing here isn't that he opted to get the shots, but that the compounder did not adhere to the safety and sterility that is rightly expected by both the medical community and the population at large. I can understand that if it is really painful for you to get the shots, that it would be hard for you to understand how anyone else would get the shots unless they absolutely had too. But each person's pain tolerance is different, and it may be that the spot where he got the injection was at a point that has less nerve endings than where you get the shot. My hope for you is that you will be able to get what you need without being exposed to infections like what these people have had to go through. My hubby and I have started talking to Mom about the possibility of trying things like a TENS unit, or acupuncture (acupuncture can be a point of infection too, but it is a lot easier for a client to tell if universal precautions are being practiced by the practitioner).
Put this guy in Prison without delay, And then give him a shot of his own medicine.
This guy is just your average greedy coward - look at him, not a shred of conscientiousness on his face.
Its time for the CEO and other managers of these companies to be held accountable. They should be charged with homicide or manslaughter, the companies put out of business permanently and tremendous fines levied with government confiscation all properties, financial accounts, etc of the business and those individuals involved. They should be sent to prison and not a country club one. Maybe, just maybe, it will wake up those contemplating such at their companies. The government is far to easy on the problems now.
Bear with me please as I explain how this mess unfolded. In 2002 the Supreme Court stripped most of the FDA's powers to regulate compounding pharmacies. The major problem then shifted to Congress failing to pass laws in 2003 and 2006 which would have given the FDA the power to create regulations for compounding pharmacy companies, similar to those drug manufacturing companies follow.
The compounding pharmacies then kept the FDA in court with lawsuits and entangled in state regulations trying to get compliance while jumping through hoops from their league of lawyers. While outbreaks of other contamination's occurred, including 22 prized polo horse deaths from contaminated vitamin shots, 3 deaths in 2006, more in 2007, and 33 cases of eye infections earlier this year. Perhaps finally regulations will be passed.
Lots of people don't understand the difference between manufacturing drug companies and compounding pharmacy companies. The article states that the FDA knew compounding pharmacies were mass producing their drugs instead of mixing them for individual prescriptions, that is true, how much is considered mass producing instead of individual amounts? Because these companies are making their products for specific doctors known to order those drugs on a regular basis, for their specific patients to use. They are not looking for new doctors to order those drugs for any patients.
Where as drug manufacturing companies make the drugs, then go and find the doctors to prescribe the drugs for their patients. Creating a market for the drugs to be used. So any drugs that compounding pharmacies make are generally for a specific reason, that the larger manfacturing companies normally would not provide.Because they are specilized,someone has an allergy to an ingredient which must be removed, it's too expensive, an orphan drug or for one reason or another needs to be customized for the patient.
These companies are the last remaining vestiges of what the corner drug store was like in the early days of American history. When you went to see your doctor, and he gave you a prescription. You took that down and handed it to the pharmacist, who mixed up what you needed behind the counter, then handed you the medicine afterwards.
The big drug manufacturing companies of today have replaced the corner drug store for the most part. Today there are 7,500 compounding pharmacies, a 3 billion dollars industry. But it desperately needs regulations to ensure top quality and safety are met.
There must be an accounting, responsibility must be placed for the conditions which led up to the contamination of the drugs which has caused the suffering and deaths of so many. Simply stating there were few regulations, isn't going to cut it. Heads are going to roll, and they must.When one holds themselves up as the standard of care, they had better be prepared to not just walk the walk and talk the talk.But put their money where their mouth is.This is gross negligence, and the CEO is the one accountable.
Windancersong--you explained it very well, thank you!
Arn't you glad that the 'de-regulators' lost the election-----"I am!!"
Regulations===="a method of keeping honest people honest!!!"
Repeating tired bumper sticker slogans just makes you look like an idiot. Regulations keep many people who otherwise might take shortcuts on the right side of the fence. If this company were required to undergo the same types of inspections and keep the same records required of other pharmaceutical manufacturers, I think it's reasonable to assume that those drugs would not have been released for sale.
But here's the problem: They have all those records, they underwent inspections. The FDA had concerns as far back as 2002. And with Ameridose, the sister company of NECC, owned by the same group of slime-bags, was recommended for shut down by the FDA in 2002. But the FDA deferred to the state, who cut a deal and put them on double secret probation.
The FDA doesn't release drugs for sale. The companies do, based on their own QC departments. These people were performing sterility testing and releasing lots before the results came back. And since 50 out of 50 vials were contaminated when tested by the FDA after people started dying, the company was obviously ignoring the results of those tests. They had the required record keeping, there was just no follow through. It's on the FDA to make sure companies are performing appropriate QC and adhering to the company's own stinking guidelines. The FDA has the authority to issue recalls and the authority to shut down plants.
The company is at fault, no doubt about it. A lot of this stuff is a no-brainer if you're trying to do even the remotest the right thing. But regulators are also at fault. They found a problem and took minimal corrective actions, never exercising their full authority to act for the public good. When the company won't act, it's the job of the regulatory agency to do so. When nobody acts, people die, plain and simple.
Point of correction, the NECC has had regulatory trouble since 2002 and cut a deal with the state. So it's even worse.
There's no doubt that the regulatory system failed in this case. My comment was in response to the idiotic inference in #10 that any attempt to regulate businesses are unnecessary.
He's already filed for bankruptcy, giving over his millions to his wife.
Bankruptcy judges frown on people who try to hide assets and screw their creditors. I know of a case where a doctor tried to hide millions in artwork. He was barred from filing for the rest of his life. That was about 10 years ago and he is diligently working to pay off his creditors.
I bet she is no better than him. Ms. Cadden is out there spending her millions right now without a worry in the world. Probably running up debt because I suspect financial assets might be frozen.
This case clearly illustrates why I refuse to take the 'Flu Shots' administered every year. These vaccines are also suspect and could easily put people at risk with tainted supplies. I prefer to take my chances through exercising healthy living practices and consistant exercise.
What are your feelings on smallpox? Or polio?
I agree. Natual immunity is much better than what these crack pot pharmacies put together...
You don't get a flu shot for yourself. You get it for others. I usually don't bother, but I did get it when I had a newborn.
J.matthew -
Why do you believe flu vaccines to be suspect? These are not prepared by compounding pharmacies, but by larger pharmaceutical companies (e.g. Sanofi Pasteur, Novartis). Just check out the CDC website
Not many people have natural immunity to polio, smallpox, diptheria, etc....
If I were him, I wouldn't talk either. There are going to be so many charges against him, he's going away. I don't see how he can get out of it, unless he can pay someone else off.
Or, he manages to sow enough doubt in the mind of a single juror.
I don't think there's a lot of room for doubt. There is a mountain of evidence against him. He may get a charge or two dropped if he's lucky.
You all want a complete investigation into how this happened and what steps can be taken to prevent it in the future? Fine. But it will mean giving this scumbag and his friends total immunity from criminal charges and civil lawsuits.
That is the only way you will get the information investigators and regulators need to prevent another outbreak.
So which is it? Throw this guy in prison? Or prevent a future outbreak? You can't have both.
If inside info is needed, there are plenty of smaller fish to cut a deal with. This piece of @!$%# needs to spend the rest of his life in prison.
Throw him in prison. They know how this happened; they just weren't able to do anything to stop it. It's because of how the laws were written.
@redphish: Indeed! And they probably don't even need inside information. Methods for keeping things sterile have been known for a long, long time. They just need the proper regulations and meaningful inspections to enforce them on tragic clowns like this Bozo.
Joe--it happened through unsanitary conditions. It is very well known how to keep facilities clean, and it isn't rocket science. Oh--and I just saw BinNH's, redphish and Severed's comments--and I agree!
I work in a research lab where the stuff I make never ever is injected into a human or even an animal. It's a small start-up without a lot of money or resources. I have always sterilized things longer than the NECC did. And I have even proved it with minimal resources. There is simply no excuse for what they did.
This guy should rot in prison! Agreed! Bet he's one of those people at the Republican convention screaming "WE built this...." by exploiting and endangering the public so I can get rich at the expense of the public's health and well being... Sorry my product might kill you.... I don't care as long as I get rich...
From the CDC ---
Multiple influenza vaccines are expected to be available during the upcoming influenza season, all containing the same antigenic composition, the CDC notes.
"We are anticipating, based on reports from manufacturers, that probably 166 million or so doses of vaccine will be produced this year; that compares with 157 million doses that were distributed last year," Dr. Bridges said.
SEVERED HEAD --
You can have all 166 Million Doses --- Enjoy -
I
i think cadden is a big piece of dung for hiding from that poor woman until after she was wheeled away after her testimony. he is a rich man because of that compounding pharmacy and now over 100 people have lost their lives due to his companies lack of oversight and compliance and he doesn't want to answer to anybody? PATHETIC! take some ownership, be held accountable and have the cojones to look the victims families in the eye. Possibly an apology would be a good place to start for this company, this man and the other owner. sadly pathetic behaviour by cadden and his defense team.
Ahem. WAS a rich man...
Stearns, a republican heading up the committee. What a joke the reps won't regulate they'll only look for a skapegoat, probably the victims.
As far as Cadden, a dose of his own medicine would be in order, as others have suggested.
Business men who endanger people's lives for profit... shouldn't get to hide behind the 5th amendment...
I'll be the big man here. Everybody should get to hide behind the fifth amendment. There's plenty of evidence without his testimony to lock him up for a very VERY long time.
My heart goes out to the victims of this tragedy. Very sad stuff. Having loved someone for so long in life just to have those years ripped away by some corporate POS(s) is very appalling. No regard for anybody these days. Maybe if we were all painted green they'd appreciate real people more.
What a coward, I hope he is sued personally and loses every dime he ever had. Though he probably has his money offshore like some others I could name.
I really hope that Barry Cadden is tried, convicted in a court of law and is sentenced to death.
Domestic terrorist who was allowed to practice under the Bush FDA/ Romney Admin in Mass. This guy is a sociopathic Republican.
We ALL know how this is going to turn out. The People get screwed as always. People are dead and no one will put this scum and partners into jail or convict them. They have rights you know. Yeah the rights to kill folks and not be accountable for their own actions. This is what the country has come to. There should be no loopholes for murderers and criminals. Can't people see the difference between right and wrong or does Money drive everything in this Sad World WE ALL live in?????
Typical congress...for years, they refused to expand the FDA's authority in regard to compounding pharmacies, and now you have some clown representative berating the FDA to act...where they have no authority.