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Archive for the ‘Johnson & Johnson’ Category

Trade Secrets Documentary by Bill Moyers

 

 

Trade Secrets – Transcripts

TRADE SECRETS: A MOYERS REPORT
PROGRAM TRANSCRIPT

TEASE:

NARRATION: They are everywhere in our daily lives – often where we least expect them.

DR. PHILIP LANDRIGAN, CHAIRMAN, PREVENTIVE MEDICINE, MT. SINAI SCHOOL OF MEDICINE: We are conducting a vast toxicologic experiment, and we are using our children as the experimental animals.

NARRATION: Not a single child today is born free of synthetic chemicals.

AL MEYERHOFF, FORMER ATTORNEY FOR THE NATURAL RESOURCES DEFENSE COUNCIL: With chemicals, it’s shoot first and ask questions later.

NARRATION: We think we are protected but, in fact, chemicals are presumed safe – innocent – until proven guilty.

SANDY BUCHANAN, EXECUTIVE DIRECTOR, OHIO CITIZEN ACTION: Years of documents have shown that they knew they were hurting people, much like the tobacco industry.

PROFESSOR GERALD MARKOWITZ Ph.D, JOHN JAY COLLEGE: Historians don’t like to use broad political terms like “cover-up,” but there’s really no other term that you can use for this.

NARRATION: In this special investigation, we will reveal the secrets that a powerful industry has kept hidden for almost fifty years.

TRADE SECRETS: A Moyers Report

PROLOGUE:

NARRATION: There is a three-hundred mile stretch along the coast where Texas and Louisiana meet that boasts the largest collection of petrochemical refineries and factories in the world.

Many who live and work here call it “Cancer Alley.”

RAY REYNOLDS: Many, many nights we were walking through vapor clouds and you could see it. You know how a hot road looks down a long straight? Well, that’s exactly what it looks like – wavy. We would complain about it, and they would pacify us by saying, there’s no long term problem. You might have an immediate reaction like nausea, but that’s only normal. Don’t worry about it.

NARRATION: In the living room of his house a few miles from the chemical plant where he worked for 16 years, Ray Reynolds waits out the last days of his life. He is 43 years old. Toxic neuropathy – poisoning – has spread from his nerve cells to his brain.

MOYERS: What’s the prognosis? How long do they give you?

REYNOLDS: They don’t. There’s too many variables, and there’s too much unknown about it.

NARRATION: Dan Ross had no doubt about what made him sick. Neither does his wife of 25 years, Elaine.

ELAINE ROSS: Went to a dance one night, and he walked in the door, and I had never seen him before, didn’t know what his name was or anything, and he started shooting pool with a bunch of his friends, and the friend that I was with, I told him, I said, “That’s who I’ll spend the rest of my life with.”

MOYERS: Love at first sight?

ROSS: Uh huh.

MOYERS: Did he think that?

ROSS: No.

MOYERS: You had to, had to…

ROSS: I had to persuade him. When we got married, he was still in the Air Force, so he spent eighteen months overseas. When he got back, he had an eighteen-month-old daughter. And so probably the main thing was, he was worried about making a living for everybody, for us.

NARRATION: The plant where Dan Ross made that living produces the raw vinyl chloride that is basic to the manufacture of PVC plastic.

ROSS: Danny worked for them 23 years – and every single day that he worked, he was exposed. Not one day was he not exposed.

As the years went by, you could see it on his face. He started to get this hollow look under his eyes, and he always smelled. I could always smell the chemicals on him. I could even smell it on his breath after a while. But even up until he was diagnosed the first time, he said, “They’ll take care of me. They’re my friends.”

NARRATION: In 1989, Dan Ross was told he had a rare form of brain cancer.

ROSS: He and I never believed in suing anybody. You just don’t sue people. And I was looking for answers. Since I couldn’t find a cure, I wanted to know what caused it.

NARRATION: Looking for an answer, she found something that raised more questions instead.

ROSS: I was just going through some of his papers, and I found this exposure record. It tells you what the amount was that he was exposed to in any given day.

MOYERS: Somebody’s written on here, “Exceeds short-term exposure.” What does that mean?

ROSS: That it was over the acceptable limit that the government allows. So this exceeded what he should have been exposed to that day.

NARRATION: There was also a hand-written instruction.

MOYERS: And then there’s writing that says?

ROSS: “Do not include on wire to Houston.”

MOYERS: Don’t send this to the headquarters?

ROSS: Right.

ROSS: My question was: Why wasn’t it included – why was it held up from going to Houston?

MOYERS: What did you take that to mean?

ROSS: Somebody’s trying to cover something up. Why?

NARRATION: Her discovery led Dan and Elaine Ross to sue.

ROSS: And I promised him that they would never, ever forget who he was, ever.

DOCUMENT WAREHOUSE

NARRATION: And this is the result of that vow.

MOYERS: How long did it take you to gather all this?

WILLIAM BAGGETT, JR, ATTORNEY: Ten years.

NARRATION: Over those ten years, attorney William Baggett, Jr. waged a legal battle for the Rosses that included charges of conspiracy against companies producing vinyl chloride. Dan’s employers – and most of the companies – have now settled. But the long legal discovery led deeper and deeper into the inner chambers of the chemical industry and its Washington trade association. More than a million pages of documents were eventually unearthed.

In these rooms is the legacy of Dan Ross.

We asked to examine the documents buried in these boxes – and discovered a shocking story.

It is a story we were never supposed to know – secrets that go back to the beginning of the chemical revolution.

NARRATION: It was love at first sight. In the decade after World War II, Americans opened their arms to the wonders of chemistry.

Synthetic chemicals were invented to give manufacturers new materials – like plastic.

Pesticides like DDT were advertised as miracle chemicals that would eradicate crop pests – and mosquitoes.

The industry boomed.

Since then, tens of thousands of new chemicals have been created, turned into consumer products or released into the environment. We use them to raise and deliver our food. We clean our carpets and our clothes with them. Plastics carry everything from spring water to cooking oil. They’re in our shower curtains and in our blood bags. They are the material of choice in our children’s toys.

But there are risks that come with the benefits of the chemical revolution.

MT. SINAI SCHOOL OF MEDICINE

MOYERS: In this arm?

NURSE: Preferably, if that’s where your vain is good at.

NARRATION: Specialists in public health at the Mt. Sinai School of Medicine in New York – led by Dr. Michael McCally – are trying to assess how many synthetic chemicals are in our bodies. For the purpose of this broadcast, I volunteered take part in their study. A much larger project is underway at the US Centers for Disease Control.

MOYERS: And you’re looking for chemicals?

DR. MICHAEL McCALLY, VICE-CHAIRMAN, PREVENTIVE MEDICINE, MT. SINAI SCHOOL OF MEDICINE: Not the body’s normal chemicals. We’re looking for industrial chemicals, things that weren’t around 100 years ago, that your grandfather didn’t have in his blood or fat. We’re looking for those chemicals that have been put into the environment, and through environmental exposures – things we eat, things we breathe, water we drink – are now incorporated in our bodies that just weren’t there.

MOYERS: You really think you will find chemicals in my body?

McCALLY: Oh yes…no question. No question.

DOCUMENTS

NARRATION: These secret documents reveal that the risks were known from the beginning. The chemical industry knew much more about its miracle products than it was telling. And one of the most toxic was vinyl chloride – the chemical Dan Ross was working with.

PROFESSOR GERALD MARKOWITZ Ph.D., JOHN JAY COLLEGE: One of the indications they knew they should have been telling the work force and public about this is that they mark all these documents “secret,” “confidential.” They tell each other in these documents – “Keep this within the company, do not tell anybody else about this problem.” So they know this is dynamite.

NARRATION: Gerald Markowitz and David Rosner are historians of public health in New York. They were retained by two law firms to study the Ross archive.

DAVID ROSNER, Ph.D., COLUMBIA UNIVERSITY: They certainly never expected historians to be able to look into the inner workings of their trade association and their vinyl chloride committee meetings and the planning for their attempts to cover up and to basically obscure their role in these workers’ deaths.

NARRATION: The hidden history begins with a document from May, 1959.

To: Director, Department of Industrial Hygiene, The BF Goodrich Company.

“We have been investigating vinyl chloride a bit. … We feel quite confident that 500 parts per million is going to produce rather appreciable injury when inhaled 7 hours a day, five days a week for an extended period.”

NARRATION: It is early correspondence among industry medical officers who were studying the effects of working with vinyl chloride. At the time, workers were regularly exposed to at least 500 parts per million.

November 24, 1959. Inter-company Correspondence, Union Carbide.

“An off-the record phone call from V.K. Rowe gives me incomplete data on their current repeated inhalation study. …Vinyl chloride monomer is more toxic than has been believed.”

NARRATION: BF Goodrich was one of the vinyl chloride producers in on the industry’s private conversations.

BERNARD SKAGGS: I started there in June–it was June the 3rd, 1955.

MOYERS: ’55.

SKAGGS: Uh-huh.

MOYERS: When you began, did you think the work might be dangerous?

SKAGGS: No. They told us it wasn’t. The only thing we had to watch about the vinyl chloride was not getting enough of it pass out.

NARRATION: Fresh out of the Army, Bernard Skaggs went to work at the BF Goodrich plant in Louisville, Kentucky.

There, vinyl chloride gas was turned into a dough-like mixture that was then dried and processed into the raw material for PVC plastic. Bernie Skaggs’ job was to climb into the giant vats that spun and mixed the vinyl chloride – and chip off what was left behind. Workers called it “kettle crud.”

SKAGGS: There was vinyl chloride everywhere. The valve, overhead valves had charging valves over there where the vinyl chloride was pumped into the reactors. All of those leaked and dripped. Most of them dripped on the floor all the time. They said it had to be – I think it was – 1,500 parts per million before you could smell it. Not only could you smell it, you could see it. It would – it would get into a vapor, and through the sunlight it waved, waves, and you see it. It was all the time that way.

My hands began to get sore, and they began to swell some. My fingers got so sore on the ends, I couldn’t button a shirt, couldn’t dial a phone. And I had thick skin like it was burned all over the back of my hand, back of my fingers, all the way up under my arm, almost to my armpit. And after enough time, I got thick places on my face right under my eyes…

MOYERS: Did you think it might be related to your job?

SKAGGS: At the start, no.

NARRATION: BF Goodrich would discover the truth.

From: The BF Goodrich Company To: Union Carbide, Imperial Chemical Industries, and The Monsanto Company.

“Gentlemen: There is no question but that skin lesions, absorption of bone of the terminal joints of the hands, and circulatory changes can occur in workers associated with the polymerization of PVC.”

NARRATION: In other words, they knew vinyl chloride could cause the bones in the hands of their workers to dissolve.

“Of course, the confidentiality of this data is exceedingly important.”

MOYERS: What does this memo tell you? This particular memo?

ROSNER: Oh, it tells me the industry never expected that they would be held accountable to the public about what was happening to the work force. They never even expected their workers to learn of the problems that they were facing and the causes of it.

NARRATION: Bernie Skaggs’ hands were eventually X-rayed.

SKAGGS: I was really shocked.

MOYERS: What did you see?

SKAGGS: Well, on the hands, my fingers were all–you know, showed up–the bones showed up white in the x-ray.

MOYERS: In a normal x-ray.

SKAGGS: Yeah, normal x-ray, yeah. And mine were okay till they got out to this first joint out there. Then from there out, most of it was black. Some of them had a little half moon around the end, and then just a little bit beyond the joint. And I said, “What is that? You’ve really surprised me.” He said, “That–the bone is being destroyed.”

MOYERS: The black showed that there was no bone there.

SKAGGS: Yeah, right. The bone was disappearing, just gone.

MOYERS: Dissolving?

SKAGGS: Yeah.

RICHARD LEMEN Ph.D., FORMER DEPUTY DIRECTOR, NIOSH: It was the slowness of action on the industry’s part that was the most striking issue in reviewing these documents.

NARRATION: Dr. Richard Lemen was deputy director of the National Institute for Occupational Safety and Health until he retired five years ago. The Baggett law firm hired him to analyze the secret documents.

LEMEN: The basic tenet of public health is to prevent, once you have found something, immediately stop exposure.

MOYERS: So they should have told the workers right then.

LEMEN: They absolutely should have told the workers. Even if it was only a suspicion, they should have told the workers what they knew and what they could do to prevent their exposure to what they thought was causing the disease.

NARRATION: That is not what happened. BF Goodrich did not tell the workers, even though its own medical consultants were reporting the truth.

October 6, 1966

“The clinical manifestations are such as to suggest the possibility of a disabling disease as a later development.”

NARRATION: What the company’s advisers feared was that the dissolving hand bones could be a warning of something even more serious.

“May be a systemic disease as opposed to a purely localized disease (fingers). …They (Goodrich) are worried about possible long term effect on body tissue especially if it proves to be systemic.”

MOYERS: “…proves to be systemic.” What’s that saying? Interpret that for a layman.

LEMEN: What that’s saying is that this disease may be much beyond just the fingertips, that it could have effects on other organs in the body or other parts of the body.

MARKOWITZ: If all the doctor is looking for is concerns about tops of the fingers and has not been told in the medical literature that this might be a systemic disease, that this information is kept within the chemical industry, then that worker is going to be misdiagnosed. The worker’s condition is going to get worse, and there is no telling what the effects are going to be for that worker.

MOYERS: He could die not knowing what had killed him.

MARKOWITZ: Absolutely.

NARRATION: Goodrich executives did tell other companies what was happening. But they hoped…

“They hope all will use discretion in making the problem public. …They particularly want to avoid exposes like Silent Spring and Unsafe at Any Speed.”

MARKOWITZ: They understand the implications of what is before them and they are faced with a situation that could explode at any minute, and they are…

MOYERS: Politically.

MARKOWITZ: Politically, culturally, economically – this could affect their whole industry if people feel that this plastic could represent a real hazard to the work force, and if it could present a hazard to the work force, people are going to wonder, consumers are going to wonder what is the impact that it could have for me.

WASHINGTON, D.C.

NARRATION: On April 30, 1969 – ten years after Bernie Skaggs first complained to the company doctor about the pain in his hands – members of the industry’s trade association met at their Washington offices. On the agenda was a report from a group of medical researchers they had hired.

Confidential. Recommendations.

“The association between reactor cleaning and the occurrence of acroosteolysis is sufficiently clear cut. The severity of exposure of reactor cleaner to vinyl chloride should be kept at a minimum…”

NARRATION: The advisers recommended that exposure to vinyl chloride be reduced by ninety per cent – from 500 parts per million to 50 parts per million. But the Occupational Health Committee rejected the recommendation.

“A motion to accept the report as submitted was defeated by a vote of 7 to 3.”

NARRATION: Instead, they changed the report.

“Eliminate the last sentence ‘Sufficient ventilation should be provided to reduce the vinyl chloride concentration below 50 parts per million.'”

MOYERS: What’s stunning to me is that at this meeting were, representing the companies, many people with MDs behind their name, MD the chairman, MD the vice chairman, MD, MD, MD. And they were among those voting against the researchers who had said we’ve got a problem here.

LEMEN: I think that that reflects who the medical doctor’s patient really was. Was their patient the workers in the plant – or were they representing their employer? This is a fundamental problem that we’ve had in public health for a long time – and that is, who is more important? Is it the chemical being produced or is it the human being producing the chemical?

NARRATION: For ten years, the bones in his fingers were disappearing. In that time, the industry never told him what it knew. Bernie Skaggs was kept in the dark – until a few months ago, when we handed him one of the secret documents.

MOYERS: There it is, in black and white. Do you want to read it?

SKAGGS: “There is no question but that skin lesions, absorption of bone of the terminal joints of the hands and circulatory changes can occur in workers associated with polymerization of PVC.”

MOYERS: That was describing the condition you had.

SKAGGS: Right, right.

MOYERS: At the same time they were –

SKAGGS: They were resisting anything –

MOYERS: They didn’t say they knew anything –

SKAGGS: And that bothers me, you know. Well, to think that they’d be this dishonest with me. After all of these years – and I put 37-1/2 years in that place – and that they could be dishonest enough not to even ever admit to me that what they did and what they had was what caused my problem.

MOYERS: Then there’s another. Let me read this. The consultants said “This may be a systemic disease, as opposed to a purely localized disease.”

SKAGGS : This is the first I’ve heard of this. I didn’t know that. The company did a good job of I guess I’d call it brain washing. They actually told us, and they told us this, that this vinyl chloride won’t hurt you.

MOYERS: What do you think when you look at all these documents?

SKAGGS: Makes me more bitter than I was.

NARRATION: By the early 1970s, Dustin Hoffman had been famously advised in the movie, “The Graduate,” that “plastics” was the future. But the vinyl chloride industry was hearing something else.

A scientist at an Italian plant, Dr. P.L. Viola, had exposed laboratory rats to vinyl chloride – and discovered cancer. As he steadily lowered the exposure levels in his tests, the cancer persisted. The discovery cast a pall over the promising future of plastic.

NARRATION: On November 16, 1971, the men from twenty vinyl chloride-producing companies gathered at the Hotel Washington to discuss the bad news.

“Publishing of Dr. Viola’s work in the US could lead to serious problems with regard to the vinyl chloride monomer industry.”

MOYERS: How would you characterize the industry discussion?

ROSNER: Close to panic. There is a whole new ball game out there about who is going to regulate industry, how much influence industry will have over these agencies, and the discovery of cancer, of course, is, you know, potentially not only a public relations disaster, but a regulatory disaster for this industry.

NARRATION: At the meeting, one of the European industry’s own scientists presented an even more disturbing report.

“Doctor LeFevre theorizes that vinyl chloride is absorbed in body fats and carried to the brain.”

NARRATION: Despite the startling prospect that vinyl chloride could affect the brain, the companies took no action – and told no one.

“The present political climate in the US is such that a campaign by Mr. R. Nader and others could force an industrial upheaval via new laws or strict interpretation of pollution and occupational health laws.”

NARRATION: A year later, another Italian researcher, Dr. Cesare Maltoni, found evidence of a rare liver cancer – angiosarcoma. In studies sponsored by the European industry, cancer appeared in rats exposed to levels of vinyl chloride common on factory floors in the US. The panicked industry came running.

MARKOWITZ: Two or three American representatives of the chemical industry go over to Bologna and the Europeans tell them that there are cancers now not only at the very high levels, at thousands of parts per million, but down to 250 parts per million. And yet they are determined to keep this secret. And they go so far as to even sign a secrecy agreement between the Europeans and the Americans so that each of their researchers will be secret from everybody outside the industry.

MOYERS: They get together, the American representatives and the European representatives, and they say this is top secret, we are not going to make it public…

MARKOWITZ: Exactly. They…

MOYERS: …to anybody? To the workers?

MARKOWITZ: To the workers.

MOYERS: To the doctors?

MARKOWITZ: To the doctors. No one is going to get this information except the companies who have signed the secrecy agreement.

NARRATION: Conoco, BF Goodrich, Dow, Shell, Ethyl, Union Carbide – some of the founding fathers of the chemical revolution – were among those who signed the secrecy agreement, even as they were admitting to themselves the bad news.

February 13, 1973. Union Carbide. Internal Correspondence. Confidential.

“Dow Chemical Company reviewed the work on the European study. They report the results on rats are probably undeniable.”

Ethyl Corporation. Inter-Office. Subject: Vinyl Chloride.

“All agreed the results certainly indicate a positive carcinogenic effect above or at 250 parts per million.”

NARRATION: The companies knew. Working with vinyl chloride – even at low levels of exposure – could cause cancer.

WASHINGTON, DC

NARRATION: By 1973, the federal government was trying to catch up with the chemical revolution.

A new agency – the National Institute for Occupational Safety and Health – NIOSH – published an official request seeking all health and safety information regarding vinyl chloride.

Two months later, a staff member of the industry’s trade association sent a letter to member companies urging that they tell NIOSH about Dr. Maltoni’s findings.

March 26, 1973

“There is the aspect of moral obligation not to withhold from the Government significant information having occupational and environmental relevance… ”

MCA BUILDING

May 21, 1973. Manufacturing Chemists Association. Minutes of meeting.

NARRATION: But meeting in their conference room in Washington, they discussed keeping secret what they knew of the dangers posed by vinyl chloride.

“We should not volunteer reference to the European project, but in response to direct inquiry, we could not deny awareness of the project and knowledge concerning certain preliminary results.”

MARKOWITZ: It is an extraordinary situation where they know they should be telling the Government about this problem. They know that they are wrong not to tell them. And then they admit that their engaging in this kind of activity can be legitimately seen as evidence of an illegal conspiracy.

May 31, 1973. Union Carbide. Internal Correspondence. Confidential.

NARRATION: A Union Carbide executive reported to corporate headquarters that if the March letter admitting knowledge of Maltoni’s work ever became public, it could…

“could be construed as evidence of an illegal conspiracy by industry…if the information were not made public or at least made available to the government.”

ROSNER: You kind of avoid as a historian the idea that there are conspiracies or that there are people planning the world in a certain way. You just try to avoid that because it’s–it seems too–too unreal and too frightening in its implications. Yet, when you look at these documents, you say yes, there are people who understood what was going on, people who thought about the crisis that was engulfing them or about to engulf them and tried in every which way to get out of that crisis and actually to, in some sense, to suppress an issue.

MOYERS: Do you think all of this added up to, to use your word, a conspiracy?

ROSNER: In a moral sense, I think it was a conspiracy.

NARRATION: We have learned from the secret archive that when the industry met with NIOSH, it did not mention Maltoni or angiosarcoma.

Union Carbide. Internal Correspondence. Confidential.

“The presentation was extremely well received and …the chances of precipitous action by NIOSH on vinyl chloride were materially lessened. NIOSH did not appear to want to alienate a cooperative industry.”

MARKOWITZ: Historians don’t like to use broad political terms like “cover-up,” but there is really no other term you can use for this because the industry had the information. They knew the significance of the information they had, and they refused to tell the Government because they were afraid the Government would take action to protect the work force.

MOYERS: And yet, during this time, Dan Ross and others like him, working in vinyl chloride plants, were being told there was nothing to worry about, that there is no danger.

MARKOWITZ: That’s correct. The industry kept assuring the work force that there was not anything that they need to be concerned about and that they were going to protect the work force.

MOYERS: But they didn’t.

MARKOWITZ: No, they certainly did not.

LAKE CHARLES, LOUISIANA

NARRATION: The companies involved were among those producing more than five billion pounds of vinyl chloride every year – and they were expanding. In 1967, one of them – Conoco – was finishing construction of a new complex in Lake Charles, Louisiana. Dan Ross moved his family into a small house less than a quarter of a mile from the new plant’s back door.

ELAINE ROSS: He went to work there, he started as a pumper loader. And he moved up fast in the first year that he was there.

MOYERS: He was eager for hard work or…

ROSS: Or he was smart, he was smart, and a hard worker.

NARRATION: Another early hire at Conoco was Everett Hoffpauir – who took the job shortly after he returned from serving in Vietnam.

EVERETT HOFFPAUIR: We were in the start-up phase, and early operation phase, and they were getting all the bugs out of it, and we had a lotta releases, and we had a lotta problems. Prevailing attitude with management at the time was “Let’s get it back online; downtime is killing us.” So as long as it wasn’t gonna blow sumpin’ up, go on in there and do what you gotta do.

MOYERS: You were breathing it?

HOFFPAUIR: We were breathing it, get higher than a Georgia pine sucking on it, you know. It’s very intoxicating. It’s a lot like propane or any other light end, it’s aromatic and, like I say, it did give you a buzz if you stayed in it long enough.

Their attitude was, if you don’t wanna do the job, there’s four waitin’ at the gate waiting to take your job. Do it – or else.

Vietnam was winding down, had a lot of people that weren’t working or if they were, were working for a lot less money. And plant jobs were very attractive. So if you didn’t want to do the work, just say so – somebody’s waitin’ to take your place.

MOYERS: So you’d worry more about your job than about your health?

HOFFPAUIR: Well, sure you were. I had a wife and three kids at home that I had to feed, you know. Yeah. But nobody told you it was a real health hazard, so you didn’t worry about it.

NARRATION: But the companies were worried.

December 14, 1971. Ad hoc planning group for Vinyl Chloride Research.

NARRATION: To counter the damaging information from the European animal studies, the industry commissioned a confidential study of its own workers that it planned to use in its defense.

“The need to be able to assure the employees of the industry that management was concerned for, and diligent in seeking the information necessary to protect their health. The need to develop data useful in defense of the industry against invalid claims for injury for alleged occupational or community exposure.”

MARKOWITZ: They are telling the scientists this is what we want. They are giving them the money to do the research, and the scientists know that in the end, they have got to come up with something that is approximate to what their funders are interested in.

MOYERS: In other words, they were saying to the epidemiologists, the researchers, the scientists, here is the end we want. Produce the science to get us there.

ROSNER: That’s right.

MARKOWITZ: When research is conducted in that way where you are trying to protect the industry, rather than give the industry the information it needs to protect the work force and the public, the process of science is absolutely corrupted.

LEMEN: Good science is to design a study that will determine whether or not there is an effect from the exposure to the chemical. And you should design that study with the greatest amount of power, the greatest amount of ability to detect whether or not there is an effect. Therefore, you should study those workers that are most directly exposed and eliminate workers that don’t have exposure. That was not done.

MOYERS: Go to the pool of affected workers, not the pool of workers who might be on the margin of the process.

LEMEN: Absolutely. They didn’t do that. They included workers in their study that were probably not ever exposed to vinyl chloride.

MOYERS: So if you bring in secretaries and managers or people out driving trucks, you’re diluting the impact of your study.

LEMEN: Absolutely. Absolutely. And you can’t get a true result when you do something like that.

NARRATION: The researchers were restricted to studying employment records and death certificates. They did not interview the workers themselves.

MARKOWITZ: They were in, from their perspective, a terrible bind. They wanted the information to know if the workers had suffered any injury as a result of exposure to vinyl chloride, but they didn’t want to tell the workers that they might have been exposed to vinyl chloride and that there was a danger in that exposure. So they didn’t want to even alert the workers in any form through these surveys that they might have had a problem that they should investigate themselves, that they should consult with their doctors about, that they should be worried about.

NARRATION: The confidential documents reveal other efforts that affected the outcome.

October 15, 1973. Vinyl Chloride Epidemiological Study. Progress Report.

“Several companies have indicated that they do not wish their terminated employees to be contacted directly.”

LEMEN: If you have workers that have left employment, they may have left because they were sick. They may have left because they had had some reason to leave. And excluding them from the study gives you a very biased result.

NARRATION: The companies also worried that if researchers contacted the families of workers who had died, someone might get suspicious.

“This becomes even more complicated when one seeks information from relatives of past employees who have subsequently died. …In other words, we need the information, but at what risk.”

ROSNER: I think this is how we, as historians, are looking at it. If you could keep that knowledge secret, keep the causes secret, keep the information secret for long enough, workers will die of other things, they’ll vanish from the work force, they’ll go on to other places, they’ll retire and die of diseases that may or may not be directly linked to the experience in the workplace.

MOYERS: How are lay people like me, citizens, supposed to decide what is good and what is bad science?

LEMEN: That’s hard. It’s real hard. Science is easy to manipulate.

NARRATION: In the end, the industry got a report that said what it wanted.

Lake Charles, Louisiana. PPG/Vista.

“Study after study has confirmed there is no evidence that vinyl affects human health – not for workers in the industry, not for people living near vinyl-related manufacturing facilities, not for those who use the hundreds of vinyl consumer and industrial products.”

NARRATION: So workers like Dan Ross were not told why they were getting sick.

ROSS: He came home from work one day, and he was taking off his boots and socks, and I looked at his feet. The whole top of ’em were burned. Now, he had on safety boots, steel-toed, and the whole top of his feet were red where the chemicals had gone through his boots, through his socks, under his feet, and burned them, both feet.

MOYERS: You knew that chemicals had caused it?

ROSS: Oh, yeah. There was no doubt in his mind, because he had been standing in something. I don’t remember what it was. I said, “My God, what was it that goes through leather, steel-toed boots and your socks to do that?” You know, I said, “Don’t get in it again, whatever it was. Don’t get in it again.”

HOFFPAUIR: I got chlorine gas and I went to the hospital, but, you know, it, it was just part a the – it wasn’t an everyday thing that you got chlorine. It was a everyday thing you got vinyl and EDC. Chlorine’s a bad, “bad news doctor” there. It’ll hurt ya. But you weren’t aware. You knew that instantly. You weren’t aware that this insidious little monster was creeping up on you, vinyl chloride was creeping up on you and eating your brain away. And that’s what it all tended out to prove out that it was doing. Just eating your brain up. Who was to know? No one told us. No one made us aware of it.

MOYERS: We can’t live in a risk-free society, can we?

HOFFPAUIR: No, we can’t live in a risk-free society. But we can live in an honest society.

NARRATION: The chemical industry was not being honest with its workers. And it was not being honest with the public.

In beauty parlors across America, hairdressers and their customers were using new aerosol sprays. No one told them they were inhaling toxic gas at exposure levels much higher than on the factory floor.

ROSNER: Vinyl chloride is a gas, and it is used as a propellant in hairsprays, in deodorants at that time, in a whole slew of pesticides and other cans that are propelling chemicals out into the environment. So, if it turns out that this relatively low threshold limit is poisoning workers, what is the potential danger if it ends up poisoning consumers?

NARRATION: Once again, buried in the documents, is the truth the industry kept hidden.

March 24, 1969. BF Goodrich Chemical Company Subject: Some new information.

“Calculations have been made to show the concentration of propellant in a typical small hair dresser’s room. …All of this suggests that beauty operators may be exposed to concentrations of vinyl chloride monomer equal to or greater than the level in our polys.”

NARRATION: The threat of lawsuits gave the industry second thoughts about marketing aerosols.

Union Carbide. Internal Correspondence. Confidential.

“If vinyl chloride proves to be hazardous to health, a producing company’s liability to its employees is limited by various Workmen’s Compensation laws. A company selling vinyl chloride…”

MOYERS: “A company selling vinyl chloride as an aerosol propellant, however, has essentially unlimited liability to the entire U.S. population.” What does that mean?

ROSNER: The problem that they’re identifying is the giant elephant in the corner. It’s the issue of what happens when worker’s comp isn’t there to shield them from suits in court, what happens if people who are not covered by worker’s comp suddenly get exposed to vinyl chloride and begin to sue them for damages to their health.

MOYERS: Unlimited liability.

ROSNER: Unlimited liability. Millions and millions of women, of workers, of people exposed to monomer in all sorts of forms. This is catastrophic. This is potentially catastrophic.

Interoffice Memo. Ethyl Corporation.

“Dow … is questioning the aspect of making sales of vinyl chloride monomer when the known end use is as an aerosol propellant since market is small but potential liability is great.”

ROSNER: They consciously note that this is a very small portion of the vinyl chloride market. So why expose themselves to liability if this minor part of the industry can be excised and the huge liability that goes with it excised?

Allied Chemical Corporation. Memorandum. Subject: Vinyl Chloride Monomer.

“Concerning use of vinyl chloride monomer as aerosol propellant, serious consideration should be given to withdrawal from this market.”

MARKOWITZ: Here you have the industry saying we are going to give up this part of the industry, the aerosol part of the industry, because the liability is so great. But they are not going to inform the work force. They are not going to do anything about protecting the work force because the liability is limited for them. And so it’s a very cynical way of deciding on how you are going to deal with this dangerous product.

They have put people in danger. They have exposed a variety of people to a dangerous product, and, yet, they are not willing to say this is something we did, we didn’t know it, we, you know, had no way of knowing it, whatever excuses they wanted to make up, but they don’t even do that.

NARRATION: Some companies would give up the aerosol business – but quietly. No public warning was issued. Now, 30 years later, those hairdressers and their customers are unaware of the risks to which they were exposed. And it is impossible to know how many women may have been sick or died – without knowing why.

LOUISVILLE, KENTUCKY

NARRATION: 1974. B.F. Goodrich announced that four workers at its Louisville, Kentucky, vinyl chloride plant had died from angiosarcoma – the rare liver cancer uncovered by Dr. Maltoni. A link to their jobs could not be denied.

But neither workers nor the public knew that the companies had kept from them the clear connection between the chemical and the cancer.

WORKER # 1: My test came back bad and I’m only 26 years old, couple of young kids, really scares you.

NARRATION: When news of the four deaths broke, two hundred seventy employees were tested. Blood abnormalities showed up in fifty-five of them.

WORKER # 2: Fifty per cent of the guys I worked with in the late fifties aren’t around now, and that’s a twenty year period. And I’ve been here twenty and a half years.

WORKER #3: It just kindly upsets me and my wife, naturally, and my mother. It’s – I know it’s a problem. It’s, it’s, it’s just – what do you do?

NARRATION: The company provided no answers. But experts like Dr. Irving Selikoff, the country’s leading specialist in occupational disease, rushed to Louisville.

WORKER #4: Have they found anything besides cancer that vinyl chloride might cause? Or have you all looked for anything besides cancer?

DR. IRVING SELIKOFF: The liver can be affected even besides cancer. Scarring can occur in the liver. Fibrosis. The blood vessels can break, the veins can break, and you can get a fatal hemorrhage, even.

WORKER #5: Once you have found that a man has this cancer caused from vinyl chloride, will you be able to cure it?

SELIKOFF: The answer is, no. At this moment, we do not know how to cure angiosarcoma.

BERNARD SKAGGS: My opinion is, if the liver thing had not come to the forefront, I don’t think they would have ever admitted anything.

MOYERS: If those guys hadn’t died.

SKAGGS: If they hadn’t died. I’m thinking about those people that I knew that died needlessly. I’m the fortunate one. I’ve lived through it. I’ve survived it. Some of them were cut off in their youth. I mean, they were young people.

NARRATION: Nine months later – over the objections of industry – the government ordered workplace exposure to vinyl chloride reduced to one part per million.

NARRATION: The aftershocks of the chemical revolution resounded throughout the 1970s. New words began to enter our vocabulary.

In Missouri, oil contaminated with dioxin had been sprayed on the dirt streets of a small working class town. When flood waters spread the poison everywhere, the entire population was evacuated.

In upstate New York, where homes had been built on a long-abandoned chemical dump, children were being born with birth defects. Love Canal was declared a disaster area.

Scientists looking for PCBs found them everywhere – in the mud of lakes and rivers, in birds and fish, and so up into the food chain. They showed up in cow’s milk in Indiana and mother’s milk in New York.

These modern poisons were not only widespread – but long-lasting.

BENZENE

NARRATION: Then came the benzene scare. Although it was known to be toxic, its use in gasoline helped fuel the American economy. But as evidence mounted connecting benzene to leukemia, the Occupational Safety and Health Administration – OSHA – ordered that workplace exposure be lowered to one part per million – a regulation the industry, then producing 11 billion pounds a year, would challenge.

DR. PHILIP LANDRIGAN, CHAIRMAN, PREVENTIVE MEDICINE, MT. SINAI SCHOOL OF MEDICINE: It’s almost inevitable that when a chemical becomes part of the political process that its regulation is going to be delayed. A chemical that has no commercial value is easy to regulate.

NARRATION: To counter the proposed regulation with its own science, the industry created and funded a $500,000 “Benzene Program Panel.”

PETER INFANTE, Ph.D., DIRECTOR OF STANDARDS REVIEW, OSHA: The science at the time was that a) benzene caused leukemia. I think there was no question about that.

MOYERS: There was no doubt in your mind that workers were at risk who were using benzene in those plants?

INFANTE: There was no doubt at all in most scientists that I spoke with. I think the only ones that had a contrary view were some scientists that represented the industry.

NARRATION: Again, the documents reveal that, just as with vinyl chloride, the industry’s own medical officers had known of benzene’s toxicity for a very long time.

MOYERS: Here’s an internal memo from 1958, 43 years ago, from Esso Oil’s medical research division. This came out of their own medical center. Quote: “Most authorities agree the only level which can be considered absolutely safe for prolonged exposure is zero.” What does that say to you?

INFANTE: There’s certainly information that the medical department has, and that information, you know, is not being conveyed to the workers, and that information is not being used to modify behavior by the company.

NARRATION: Instead of changing its behavior, the petrochemical industry turned to the courts to stop the regulation. The companies argued that reducing exposure to benzene would be too costly.

October 11, 1977

“We assert that there is no evidence that leukemia has resulted from exposure to benzene at the current concentration limits. The new and lower limitation on exposure would represent an intolerable misallocation of economic resources.”

NARRATION: The Fifth Circuit Court of Appeals in New Orleans – in America’s petrochemical heartland – ruled that the government had not proved the danger to humans to be great enough to justify the cost to industry. The victory propelled an offensive directed by the now re-named Chemical Manufacturers Association.

September, 1979. A Summary of Progress. Presented to the Board of Directors.

“Gentlemen, this is a campaign that has the dimension and detail of a war. This is war – not a battle. The dollars expended on offense are token compared to future costs.

“The rewards are the court decisions we have won, the regulations that have been modified, made more cost effective or just dropped. The future holds more of the same.”

DBCP

NARRATION: The companies had their battle plan in place when trouble erupted over a little-known pesticide – produced by Dow, Occidental and Shell – called DBCP.

WORKER #1: I worked in the DBCP unit itself manufacturing the chemical. And now after telling me that I shouldn’t worry about anything out there because it can’t hurt me, now to find out that I’m sterile from it, their answer was, don’t worry about that because you can always adopt children.

NARRATION: Talking among themselves, workers had figured out that many of them could not have children. Company officials claimed there was no pattern – and no evidence, even though newly-ordered tests proved disturbing.

WORKER #2: They ran a series of four sperm counts on us over a period of, I guess, two or three months. All my sperm counts came up zero. And I’d never been told in the whole time I’d been working out at Shell that this might happen to me.

NARRATION: What the industry also didn’t tell was that its own scientists had known of the dangers for decades.

Dow Chemical Company Biochemical Research Laboratory. July 23, 1958

“Testicular atrophy may result from prolonged repeated exposure. A tentative hygiene standard of 1 part per million is suggested.”

NARRATION: Dow had treated the report as “internal and confidential,” did not reduce exposure to DBCP – and did not tell the truth.

V.K. ROWE, Dow Chemical Company: It is our regular policy wherever to totally inform people about what the material is that they’re working with and what its potential is. So I can’t say precisely what was said in one situation. It’s generally throughout the company that we try our best to inform people about what are the hazards, how to avoid them and what to do if they have an accident – or what.

WORKER #2: The thing that bothers me, I think, more than anything is the fact that the chemical industry had no interest whatsoever in protecting us through telling us the dangers of what we were working with.

NARRATION: The companies were neither protecting their workers – nor their neighbors. An engineer at Occidental had alerted his plant manager.

April 29, 1975. Inter-office memo.

“We are slowly contaminating all wells in our area and two of our own wells are contaminated to the point of being toxic to animals or humans. THIS IS A TIME BOMB THAT WE MUST DE-FUSE.”

AL MEYERHOFF, FORMER ATTORNEY FOR THE NATURAL RESOURCES DEFENSE COUNCIL: DBCP was a reproductive toxicant, a very powerful carcinogen. It was found in drinking water wells throughout the country. It stayed on the market because to ban it, you first had to have an administrative process within a Government agency that was under great political pressure from power people on Capitol Hill. If you put enough hurdles up even the best-intentioned Government regulator is hamstrung.

NARRATION: The companies kept DBCP on the market for eight more years. And it would take a decade for the best-intentioned regulators to finally reduce the exposure level to benzene. By then, the evidence was so overwhelming the industry did not challenge the regulation. For some, it came too late.

LANDRIGAN: We knew how many chemical workers there were, how many rubber workers, how many petroleum workers, how many workers in other industries that were exposed to benzene, and on the basis of knowing how many were exposed and knowing the levels at which they were exposed, we were able to calculate how many unnecessary deaths from leukemia resulted from exposures during that 10-year delay.

MOYERS: How many?

LANDRIGAN: And the number was 492 unnecessary deaths from leukemia. Deaths that almost certainly would have been prevented if the standard had been reduced to 1 part per million back in the 1970’s.

MOYERS: What are the lessons that you would have us draw from this case of delay?

LANDRIGAN: Well, I think the most fundamental lesson is that we have to presume chemicals are guilty until they are proven innocent. What’s needed is an unpolluted political structure that is empowered to set regulations that protect the public health.

NARRATION: That’s not the political structure the industry wanted.

September 8, 1980. Report to the Board.

“The cold fact is that the Congress today has more influence over the agencies than the White House does.

“For even our best friends in Congress, there’s a limit to how long they’ll support us if the public’s against us.”

WITNESS IN HEARING: The industry’s gotten away with murder. That’s why they don’t move forward. Because it’s cost them some money and some effort, and if they’re not pushed, they won’t move.

“We need real muscle, the kind none of your lobbyists are likely to have as individuals. One growing source of political strength outside Washington is the Political Action Committees. PAC contributions improve access to Members.”

NARRATION: Through almost two hundred quickly-formed political action committees, the industry would contribute over six million dollars to the 1980 election campaign.

“When the time comes to play hardball, we’ll try to make good use of the political muscle you’ve been helping us develop.”

REAGAN INAUGURATION

NARRATION: Ronald Reagan was petrochemical’s favorite Presidential candidate. And four of the top five Senate recipients of the industry’s largesse were Republican challengers who defeated incumbents.

The industry was ready to play hardball.

September 28, 1981. Government Relations Committee. Pebble Beach.

“The Committee believes that the new climate in Washington is more reasoned and responsive. …The election of the Reagan Administration appears to have produced changes which bode well for our industry.”

NARRATION: The Reagan team asked business for a wish-list of actions that could be completed within the first 100 days. In less than a third that time, the new President signed an executive order that transformed the battle over the safety of chemicals.

CHANGES FOR THE BETTER

“President Reagan directed EPA to delay proposing or finalizing regulations until it could be determined that they were cost-effective and necessary.”

NARRATION: A prime target was the one law intended to give the Environmental Protection Agency broad authority to regulate toxic chemicals – the Toxic Substances Control Act – TSCA.

JACQUELINE WARREN, FORMER ATTORNEY FOR THE NATURAL RESOURCES DEFENSE COUNCIL: The whole theory of TSCA was that we’re not going to keep waiting until we can count the bodies in the street. We’re going to do some preliminary steps early on, catch the problems in the laboratory, get rid of them, identify the really bad actors, take some steps to reduce exposures, to find substitutes for these. That was the theory. It just in practice has never worked.

NARRATION: Case in point: A class of chemicals known as phthalates. In 1980, the National Cancer Institute had determined that one phthalate – DEHP – caused cancer in animals. By the time the Reagan Administration came to town, the Chemical Manufacturers Association was already spending hundreds of thousands of dollars on efforts to thwart any regulation.

“We must arm ourselves with cost calculations for alternate environmental control strategies; and we must feed that information to EPA as early as possible.”

NARRATION: Industry representatives and attorneys met three times with the number two man at the EPA. No environmental or consumer organizations were invited – or informed. Jacqueline Warren was one of those closed out.

WARREN: And we weren’t really there to say, “We represent another point of view on this that you should hear before you decide to go along with what the industry might be proposing”, since their interest is much narrower. They’re interested in their bottom line, their stockholders, their product, and they’re not as interested at all in what the potential health or safety or environmental effect of exposure to this might be. In fact, they’d rather keep that quiet if they can.

NARRATION: Although phthalates are widely used in common products from shower curtains to children’s toys, the EPA announced it would take no action to either ban or limit the uses.

MEYERHOFF: We refer to it as the Toxic Substances Conversation Act.

MOYERS: Because?

MEYERHOFF: They built in obstacle after obstacle and process after process where it is virtually impossible to get a known high-risk chemical off the market. There have been very few chemicals that have been actually banned because of their health risks. That’s because chemicals get far more due process than people do.

MOYERS: Chemicals have more rights than people?

MEYERHOFF: Far more rights than people.

NARRATION: The public protested that the Environmental Protection Agency had become a captive agency. What the public protested, the industry celebrated.

January 11, 1982. CMA Board of Directors. Grand Ballroom, Arizona Biltmore.

“Just ten days ago, TSCA celebrated its fifth birthday. The first five years of TSCA have seen numerous rules proposed by the Agency. To date, we have seen none of these types of rules finalized.”

WARREN: In terms of what we thought TSCA was going to mean, we haven’t made a big dent in getting tested the very large number of chemicals that are all over the environment and to which people are exposed to all the time, for which there are some data already available to suggest that they may be harmful. We’re still having to wait until the actual harm appears, and then try to do something about it.

MOYERS: Who’s in charge of the process now? LEMEN: The industry.

MOYERS: Regulating itself?

RICHARD LEMEN Ph.D., FORMER DEPUTY DIRECTOR, NIOSH: They’re in charge of doing that. The government is supposed to, but the industry has so much control through the lobbying efforts that they actually indeed do control it themselves.

NARRATION: To this day – almost 25 years after the Toxic Substances Control Act was enacted – only five types of chemicals, out of thousands, have been banned under the law.

INSTITUTE, WEST VIRGINIA

NARRATION: August 11, 1985. The accidental release of a toxic cloud from a Union Carbide plant in Institute, West Virginia sends 134 people to the hospital. It is only eight months after an explosion at a Union Carbide plant in Bhopal, India had killed some 2000 people – and injured 200,000 more.

REPORTER: When they told you it was a leak, what was the first thing that went through your mind?

MAN: India. Because you’re so helpless.

WOMAN: They didn’t know where it came from, they didn’t know what it was till two days later after it happened. You fumble and stumble and cause our lives to be turned upside down over things you misplaced – over 500 gallons of this mixture. Now I can see misplacing one or two gallons of gasoline around your house…

ROBERT KENNEDY, PRESIDENT, UNION CARBIDE: If we don’t make those chemicals, someone will. Someone will make those chemicals, and you know, you can wish the problems on somebody else. I had a dog once who overly aggressive and he bit a mailman once. And he missed a mailman about three times. And I was very upset about it. And I asked a vet finally if she thought that I could find a good home for that dog. And she said, Mr. Kennedy, don’t give your problem to somebody else. And I think I learned something by that. I don’t think we want to quit.

MAN IN AUDIENCE: When will you listen? I don’t want to hear your dog stories. We’re talking about people. And their lives and their homes and their families. You can have my job if you want it. Because by god, I can get another job. I can’t get another life.

NARRATION: Accidents were but one symptom of our co-existence with industrial chemicals.

In the late 1980’s, people began to agitate for the right to know more about the chemicals that they – and their children – were being exposed to.

WOMAN: I don’t think we should be afraid any more about talking about controls on the chemical industry. These are private companies -Carbide, DuPont, FMC, all of them – whose day to day decisions in those corporate board rooms are affecting our lives, our children’s lives, and the future generations.

MAN: What about cleaning up the industry? Stop the leaks, for Christ’ sake. Don’t kill me. Let’s do something.

NARRATION: In California, they did do something. In 1986, citizens themselves rounded up enough signatures to put the Safe Drinking Water and Toxic Enforcement Act – Proposition 65 – on the California ballot.

MEYERHOFF: With Prop 65, if you are a manufacturer of a chemical and you’re exposing my family to a health hazard in a consumer product, in the workplace, in the air and the water, you have to warn me, and that makes a big difference because the public then doesn’t buy the product and it shifts the burden to the company.

MOYERS: You were really turning the system of regulation upside-down.

MEYERHOFF: Yes. It turned the entire system on its head, and that’s why the chemical industry and agriculture and others in California fought the law so hard.

NARRATION: Once again, we have learned from the secret documents how industry planned to fight.

June 4, 1986 California Toxics Initiative.

“A campaign fund of $5 million dollars has been targeted, with a broad coalition of industry and agricultural interests having been formed to finance and manage the campaign.”

MOYERS: “A total of $150,000 is needed by June 25th for fund-raising, research, and advertising, an additional $650,000 payable during July, August, or September.”

MEYERHOFF: Well, I always knew there were resources against us. I actually was unaware of the amount. That actually surprises me that there was quite that high level of dollars, and that was a lot of money then, to oppose Prop 65.

NARRATION: But the industry had been caught short; its money came too late. On election day, California’s right-to-know proposition passed – overwhelmingly.

MEYERHOFF: What the voters were saying is that we don’t trust the Government to protect us any longer from chemicals that cause cancer or birth defects or other harm, give us the information, tell us when we are at risk, we’ll protect ourselves. That was the basic message. And if you fail to do that, then you, a chemical company or grower or others, can be fined up to $5,000 per day, per person that isn’t warned. Prop 65 put the fear of God in the chemical companies, and it had never been there before.

NARRATION: Afraid of aroused public opinion, the companies vowed never to be caught short again.

June 3, 1987 Board of Directors Meeting. Chemical Manufacturers Association. State Toxics Initiatives

“Development of a funding plan which would include an industry-wide ‘pledge’…”

MOYERS: …”pledge” of resources company-by-company, pre-authorization to commit the funds to individual state campaigns.” Does that surprise you?

SANDY BUCHANAN, EXECUTIVE DIRECTOR, OHIO CITIZEN ACTION: Well, it helps me understand why they were able to marshal their forces so quickly in Ohio and from so far across the country, the idea that they were ready for it and committed.

MOYERS: But you didn’t know about this?

BUCHANAN: No. I didn’t know about that until just now.

NARRATION: Sandy Buchanan heads Ohio Citizen Action, the group which took the lead in getting a right-to-know initiative on the Ohio ballot in 1992.

MOYERS: Though you didn’t know it at the time, I assume you were up against a lot of that money?

BUCHANAN: We were up against about at least 4.8 million of it.

MOYERS: 4.8 million.

BUCHANAN: That was the final spending on the actual ballot campaign.

MOYERS: By the industry.

BUCHANAN: By the industry in Ohio. They definitely spent more money than that, though, because at every stage of the process through the legislature and others, they brought us to court and they tried to challenge the legality of our petitions.

MOYERS: So the industry spent 4-point–

BUCHANAN: 4.8 million dollars on the ballot.

MOYERS: And how much did you spend in trying to pass it?

BUCHANAN: Oh, about 150,000.

MOYERS: I would say you were outspent.

BUCHANAN: About 50 to 1 or so, yeah.

NARRATION: For the companies, the dollars spent to defeat the initiative were insurance against the greater loss of being held accountable.

BUCHANAN: If they can’t be held liable, if the tools that citizens or workers can use to try to defend themselves are taken away, then you can protect the bottom line of a corporation.

MOYERS: It would cost them money if people knew.

BUCHANAN: It would absolutely cost them money.

NARRATION: No state right-to-know initiative has passed since 1986. And two years ago, industry persuaded Congress to roll back a major right-to know provision in the Clean Air Act.

TEST RESULTS

NARRATION: Today, an average of twenty new chemicals enter the marketplace every week. We don’t know much about them – and we don’t know what they might be doing to us.

Back at the Mt. Sinai School of Medicine, Dr. Michael McCally was ready to tell me if residues of the chemical revolution had been found in my blood.

MOYERS: So what’s the news?

DR. MICHAEL McCALLY, VICE-CHAIRMAN, PREVENTIVE MEDICINE, MT. SINAI SCHOOL OF MEDICINE: We tested for 150 different industrial chemicals, and you have 84 of those 150.

MOYERS: Wow. Eighty-four.

McCALLY: Eighty-four.

MOYERS: If you had tested me sixty years ago when I was six years old, would you have found those chemicals?

McCALLY: No. No. With one exception.

MOYERS: What’s that?

McCALLY: Lead.

MOYERS: Lead.

McCALLY: Lead. Lead’s been around — we’ve been — we’ve been poisoning ourselves with lead since, you know, practically the cave ages.

MOYERS: So 83 of these 84 chemicals you found in my blood are there because of the chemical revolution –

McCALLY: Yes.

MOYERS: — over the last sixty years.

McCALLY: That’s correct. That’s correct. And we didn’t know this until we looked, but suddenly we find out that the industry has put a bunch of chemicals in our body that, you know, are not good for us, and we didn’t have any say in that. That just happened.

MOYERS: What kind of chemicals?

McCALLY: In the PCB case, you have 31 different PCBs of this whole family of similar chemicals. They are all over the place. And it’s probably a function of where you lived. You lived in some locale where PCBs were in the environment, and you got them into you through the air you breathed. Some of them get down in groundwater. Some of them get coated on food. You didn’t get them sort of in one afternoon because you ate a poisoned apple.

MOYERS: And dioxins?

McCALLY: And dioxins, of all that we measured, you had 13, 13 different dioxins.

MOYERS: You tested for some pesticides.

McCALLY: Yes. The organophosphates — malathion is one we may have heard of because we’re spraying it here in New York because of mosquitoes.

MOYERS: I used to spray malathion on my house in Long — on my yard in Long Island.

McCALLY: We also measured organochlorine pesticides. The best known is DDT. DDT hasn’t been produced in this country for several decades.

MOYERS: Yes. So where would I have gotten that?

McCALLY: Did you ever, you know, watch them spray the trees when you were a little kid?

MOYERS: Young man.

McCALLY: A young man? Yes. Okay.

MOYERS: And I lived around places that had used it.

McCALLY: Well, that’s enough, because again, like PCBs, these are very persistent chemicals. They don’t — the body doesn’t metabolize them, doesn’t break them down into little pieces and get rid of them.

MOYERS: How do the results of my test compare with others around the country?

McCALLY: I wish we had more data. I wish I could give you a clear answer to that. The burdens that you carry are probably biologically less important than if you were, you know, a 21-year-old woman who was in her ninth week of pregnancy. And then the fact that you were circulating some DDT might really be important.

MOYERS: Have these chemicals been tested in terms of what happens when they are combined?

McCALLY: No. No. That is a complexity that we haven’t even looked at.

MOYERS: Have they been tested on vulnerable populations like children?

McCALLY: No. We are just beginning to do that science.

MOYERS: Is it fair to say from all of this that we are, as human beings, being unwittingly exposed to hundreds of toxic chemicals which have been tested enough just to know that they’re toxic, but not tested enough to know the risks?

McCALLY: That’s a fine summary of the current state of affairs. We know enough now to know that it doesn’t make a lot of sense to make chemicals that are carcinogenic and add them to our bodies and then argue about how much we are adding. It just isn’t a good idea. Particularly when there are perfectly acceptable alternatives, and if the industry chose, it could change our exposures dramatically by its own actions.

NARRATION: Three years ago – on the eve of Earth Day – the Chemical Manufacturers Association promised that its member companies would begin to voluntarily test one hundred chemicals a year at an estimated cost of 26 million dollars.

FRED WEBBER, PRESIDENT, CHEMICAL MANUFACTURERS ASSOCIATION: Our vision is that we will be highly valued by society for our leadership, for the benefits of our products and for the responsible and ethical way in which we conduct our business. It’s as simple as that.

NARRATION: Today, we are still waiting for the results of even one of those tests.

During those three years, the industry poured more than 33 million dollars into the election campaigns of friendly politicians.

NARRATION: As the secret documents reveal, the promise to test – voluntarily – was part of a strategy hatched almost a decade ago.

September 15, 1992:

“A general CMA policy on voluntary development of health, safety and environmental information will…potentially avert restrictive regulatory actions and legislative initiatives.”

MEYERHOFF: The idea of a chemical company voluntarily testing its product is not unlike efforts to voluntarily regulate their products. It is an attempt to pre-empt effective government. It is an attempt to try to stop the government from doing its job by doing half-baked measures and then claiming that we’re protecting the public.

DR. PHILIP LANDRIGAN, CHAIRMAN, PREVENTIVE MEDICINE, MT. SINAI SCHOOL OF MEDICINE: There are 80,000 different man-made chemicals that have been registered with the EPA for possible use in commerce. Of those 80,000, there are about 15,000 that are actually produced each year in major quantities, and of those 15,000, only about 43 percent have ever been properly tested to see whether or not they can cause injury to humans.

NARRATION: The industry’s own documents confirm just how little we know.

Meeting of the CMA Board of Directors. Pebble Beach. Report of Health Effects Committee.

“The chemical industry has contended that while a few substances pose a real risk to human health when sufficient exposure occurs, the vast majority of chemicals do not pose any substantial threat to health. However, the problem is, very little data exists to broadly respond to the public’s perception and the charges of our opponents.”

NARRATION: That is worth repeating. “The problem is, very little data exists.”

In other words, the industry itself acknowledged it could not prove the majority of chemicals safe.

LAKE CHARLES, LOUISIANA

NARRATION: Lake Charles, Louisiana. In the spring of 1989, the family of Dan Ross gathered to celebrate their daughter’s graduation from college.

ELAINE ROSS: He was always the kind of man that wore denim. Denim shirts, denim pants. In fact, he got downright indignant if we tried to make him dress up. We thought that was what was wrong with him. He’d complained about having a headache that day, and Robin told him – that’s our daughter. She said, Daddy, you’re not wearing that to my graduation. You’re wearing a suit. We assumed that the look on his face was that he was mad at all of us and was gonna let us remember it forever, you know. And we laughed at him and teased him about it. But afterward, the headache didn’t go away.

NARRATION: Several days later, a CAT scan revealed brain cancer. In the last words he was able to speak, Dan Ross told his wife, “Mama, they killed me.”

ROSS: You start watching him die one piece at a time, you know. It’s like, okay, he’s blind today, but he can still hear, he can still swallow if I put something in his mouth. But he lost the use of one of his arms, and then next day it would be the other arm, the next day it would be one leg. And then he couldn’t hear anymore. The hardest part was when he couldn’t speak anymore.

NARRATION: On October 9, 1990, twenty-three years to the day after he started working at Conoco, Dan Ross died. He was 46 years old.

ROSS: They hurt somebody that meant more to me than my whole life. I would have gladly taken his place to die. Gladly.

NARRATION: Half a century into the chemical revolution, there is a lot we don’t know about the tens of thousands of chemicals all around us.

What we do know is that breast cancer has risen steadily over the last four decades. Forty thousand women will die of it in this year alone.

We do know brain cancer among children is up by 26 per cent. We know testicular cancer among older teenage boys has almost doubled, that infertility among young adults is up, and so are learning disabilities in children.

We don’t know why.

But by the industry’s own admission, very little data exists to prove chemicals safe.

So, we are flying blind. Except the laboratory mice in this vast chemical experiment are the children.

They have no idea what’s happening to them. And neither do we.

PANEL DISCUSSION

MOYERS: Now we want to discuss some of the public policy issues raised by what we’ve seen.

With me are Terry Yosie, Vice-President of the American Chemistry Council; Ted Voorhees, partner in the law firm of Covington & Burling – he represents the Chemical Trade Association in the Ross case; Ken Cook, President of the Environmental Working group — as a matter of disclosure, the foundation I serve made a small grant to Mr. Cook’s organization a few years ago, but I didn’t meet him until three weeks ago — and Dr. Phil Landrigan, a pediatrician and chairman of preventative medicine at Mount Sinai School of Medicine.

Mr. Yosie, thank you very much for coming.

TERRY YOSIE: Thank you.

MOYERS: Given what we’ve just seen, how can the public rely on what the chemical industry says about the safety of synthetic chemicals?

YOSIE: Thank you, Mr. Moyers. If I were a member of the viewing audience tonight, I would be very troubled and anguished if I thought that the information presented during the proceeding 90 minutes represented a complete and accurate account of the story. It does not. For nearly two years, this program has been in preparation. At no time during that two year period have representatives of this program contacted our industry, asked us for information, or provided an opportunity for us to appear on the 90-minute segment.

We believe that it is a sad day in American journalism when two sides of the story can’t be told, when accuracy and balance are not featured in the broadcast. It’s our intention in the limited about of time that we have available this evening to correct some of the errors that we found in the broadcast, but also to present a more complete picture of who this industry does and what it represents and the benefit it delivers for the American people.

How can– turning to your question Mr. Moyers– how can the American people be reassured that the products developed are safe for the intended uses? We test our products and we report that information to the government. There are 9,000 chemical products on the marketplace today. They have been researched, they have been tested, and that information has been disclosed. We do not do this information alone. We work with some of the finest universities in the United States: people at Harvard, the University of California system, the University of Massachusetts– independent researchers with world-class reputations.

We have a major partnership with one of this nation’s leading environmental groups, Environmental Defense, and through that partnership we are disclosing information on those test results no matter what they show. So I believe this commitment to openness and transparency, to working together to identify information needs and to disclose this to the public is to pass the greater confidence in the products we make.

MOYERS: Mr. Cook, do you want to talk about that?

KEN COOK: Well, it’s interesting that you raised the question of testing. As I was struck by so many images in this program, one of the images was that of the x-rays of these vinyl workers who you had in your industry, medical doctors examining without telling them why they were examining them. Their fingers dissolving and this new program you’re describing, the symbol of it is two hands holding a globe. I don’t think I will ever be able to look at the logo for your program without thinking of those vinyl workers and their dissolving finger bones.

As for testing, one of the things that was striking about Bill’s results as I was thinking about it, was just how little is known about the products of your industry showing up in people. Do you, for all your testing you’re saying is being done, do you have any idea how many of the products of your industry, all your companies– it’s a good bit more than 9000– do you know how many show up in people? Have you even tested for that?

YOSIE: Let us respond to some of the issues you’re raising.

MOYERS: You don’t want to answer?

COOK: So you’re testing?

YOSIE: I want to respond to the issues that…

MOYERS: Before you do…

YOSIE: I think the viewers deserve our correction of some statements.

MOYERS: Well we’ll turn to it in just one minute, but how thoroughly are these chemicals tested before they come on to the market?

YOSIE: They are tested using the best scientific methods available, and they are tested not only for their potential hazard, but when we test a product, when we submit that information to the government, we are using standards set by our government, but also international standards. We are applying the best laboratory practices that have been defined by the scientific community.

We don’t do this work in isolation, and when we develop a product, we have margins of safety so that whatever potential effects there may be, we develop those products so that they ensure safety many times below where there could ever be an effect. Subsequent legislation has ratified that approach that we have taken for many years.

COOK: But this is legislation that you have opposed. I mean, your own documents show– whether it’s the clean air act, the clean water act, the safe drinking water act– straight on through, you can read the documents now for the first time that you have never made public before, and it’s quite clear that every time there’s an attempt to tighten regulation on your industry to protect citizens, communities from air pollution, water pollution, your own documents show how you have opposed that.

MOYERS: Let me bring Mr. Voorhees in on this.

TED VOORHEES: Thank you, and let me say that I have met Mrs. Ross, and I have a tremendous amount of sympathy for her situation having lost her husband to brain cancer. At a human level I have sympathy, but no amount of sympathy can justify putting on a program that presents an incomplete, slanted, and essentially misleading characterization of what happened with vinyl chloride.

And to take Ken’s example of the hands, as the first of a couple of examples let me give, the show tells the viewer that this hand problem appeared in the mid 1960’s, and that it was treated as confidential and secret by the industry. What the show doesn’t state is that as soon as that problem was found by B.F. Goodrich company, the doctor who found that problem in 1967, published his findings in the Journal of the American Medical Association, which is probably one of the most widely read professional articles read by doctors, and in that article on the hand problem, Dr. Creech included the very same x-ray images which you showed on your program as if they had been hidden and kept secret from people.

MOYERS: Did that document say that it was linked to the exposure of vinyl chloride?

VOORHEES: It absolutely did, that was the whole subject of the article.

MOYERS: Why didn’t the company tell Bernie Skaggs?

VOORHEES: Bernie Skaggs’ doctor knew about that because he read it in the Journal of the American Medical Association.

MOYERS: But why didn’t the company tell him?

VOORHEES: The company was telling his doctor — the person who would know and who would be able to react to something like that is a professional who would be able to see the relationship.

MOYERS: I believe the documents show that the company did not tell his doctor.

VOORHEES: Well, they published the study of the hand problem in the Journal of the American Medical Association in 1967.

MOYERS: So was the doctor expected to just come across that in random reading? Why didn’t the company tell Bernie Skaggs directly? He worked for the company, Mr. Voorhees. Why didn’t they tell him?

VOORHEES: The Journal of the American Medical Association, JAMA, is not random reading. It’s probably the most widely read professional journal…

MOYERS: Sir, you’re not answering the question. Why didn’t the company tell its employees?

VOORHEES: I don’t know that they didn’t tell Bernie Skaggs.

MOYERS: The documents suggest they didn’t.

VOORHEES: The B.F. Goodrich company had a doctor at the plant. He was the author of this article in JAMA and he would have, as workers came into see him, he would have explained to them what their problem was and I would expect that would happen.

MOYERS: Was Bernie Skaggs lying to me when he said the company didn’t tell him?

VOORHEES: I am certainly not going to accuse him of lying, but what I’m saying is that the doctor at his plant published his findings immediately in the Journal of the American Medical Association and my point is, the program has suggested to your viewer that this was an issue that was kept in secret. Far from keeping it in secret, it was published in the most widely read journal, and the x-rays that were supposedly kept secret were a part of that journal article.

YOSIE: 40 years ago is a very long time. 40 years ago there wasn’t an Environmental Protection Agency. 40 years ago there wasn’t a clean air act. I don’t believe the viewers of this program are interested so much in what happened 40 years ago. I believe they are vitally interested in their own personal health and wellbeing today. They want to know that if the products that we develop and market are safe for their intended uses. They want to know if the products that they’re using in their homes are going to benefit them. and I believe the answer is…

MOYERS: Those are the questions that I sent you a month ago and said, “let’s talk about these policy issues.”

YOSIE: Those are the questions I absolutely want to address.

MOYERS: What about that?

LANDRIGAN: I think that’s really the central question, Bill, Terry.

Today there are many thousands of chemicals on the market. There are a number of chemicals that are registered with the EPA for commercial use is not 9,000; it’s over 80,000. There’s about 3,800 which are called “high production volume chemicals.” A couple of years ago, the Environmental Defense Fund, the same organization with which the chemical manufacturers are partnered, did an analysis of those high production volume chemicals to see what fraction has been tested. Now, to be sure, when the EDF were seeking information on how many were tested, they had to go to the open literature. They obviously didn’t have access to company documents.

In the open literature they found that only 43%, less than half of these chemicals had ever been tested for toxicity to humans. When they looked more deeply, when they asked more sophisticated questions, for example, what fraction of these chemicals has been tested for their effects on children’s health?

What fraction have been tested for the effects on the developing brain, the developing immune system, the developing reproductive organs, the endocrine system of babies? You’re down very close to single digits. Around 8% or 10% of chemicals on the market have ever been tested for these effects.

So I think that it has to be said here today that the toxic substances control act is a well-intentioned piece of legislation, but in its execution, it has mostly been a failure. It is just not doing an adequate job of protecting the American public.

YOSIE: There are not 75,000 products on the market today. There are 9,000.

LANDRIGAN: No, there are not 75,000 chemicals on the market, but there are that many chemicals registered with the EPA for commercial use. And of the 38,000 high production volume chemicals, fewer than half, less than half have been tested for their toxicity.

YOSIE: Mr. Moyers, you’ve had your own body tested and this was shown to the viewers. What was not shown to the viewers, that the products that we make probably saved your life. From what I read in the newspapers, you had a very serious heart operation at about 1994. You had a blockage in an artery leading to your heart. When your doctors discovered this problem and advised you and provided the professional counseling and expertise that made it possible for you to recover to the robust man that you are today, they were using our products. They diagnosed…

MOYERS: Are you sorry about that now? I mean, don’t you wish…?

(laughs)

YOSIE: I am delighted that you’re here. You look very healthy. They diagnosed your problem using technologies that we helped develop. When they operated on you, they used surgical instruments that we helped develop. To ensure that you did not contract a subsequent infection post operation, you were given medicines.

In addition, you were probably given medication afterwards to ensure your continuing return to health. I believe that your state of well-being today was directly dependent on the benefits that our industry provided to you and to every American.

MOYERS: I don’t challenge that, and I didn’t challenge that in our reporting. I do not challenge that.

YOSIE: You do not challenge that but you didn’t report it either.

MOYERS: You just said it. I told you a month ago we wanted you to come on and say what you wanted to say and you just did. But here is the issue that I think that Dr. Landrigan is raising, that my own body burden test is raising, Dr. McCally said to me, I said to him, “Should I be worried?”

He said, “At your age, 66, I don’t think so. But if you were a 21-year-old pregnant woman, it might be a different story.” And he said, “We do not know what this combination of chemicals, what effect it’s having on our health.” This is a new phenomenon. He said, “Your grandfather would not have had this.” This is a new phenomenon. And what I think I was asking in the broadcast, and what I hear Dr. Landrigan asking is, how do we find out what this combination of chemicals is doing in our body? Particularly to children. Are children the most vulnerable?

LANDRIGAN: Children…

YOSIE: Dr. McCally erred in what he told you. He said that 60 years ago the only compound that you would have in your body was lead. 60 years ago, American cities looked like an industrial wasteland. They looked like what Russia or China or Eastern Europe looks like today. 60 years ago, there were no pollution controls on industry or any other major products. 60 years ago, the area that I come from, Western Pennsylvania, people had to wear two shirts to go to work. One to wear outside, one to wear inside.

MOYERS: “Better living through chemistry.” I acknowledge that. We all acknowledge that.

COOK: I think as an environmentalist, I’ll defend your industry. But the thing that surprises me…

YOSIE: Thank you, I’ll take that compliment.

COOK: Let’s go back to the vinyl story. Again, for the first time now it are read tens of thousands of pages of documents that you never made public. If they so strongly defend your position, you never made them public. Now that they are public, one of the striking things about me is how you’re hiding your light under a bushel basket when it comes to inventiveness. Those documents clearly show again and again and again that your industry worried that if vinyl chloride standards were tightened, it would be the end of the industry. Companies would go bankrupt. They say this. They could not continue to operate.

None of them did go bankrupt when it went from 500 parts per million down to one. They all did fine. In fact, they made money. And I think what I respond to you when you make that point is, yes, there are many ways which chemicals make a difference in our lives. But there are also ways in which we can find safer alternatives. And in most cases, the fastest was to those alternatives is to put pressure on the industry beyond what you feel now to move you in that direction. You don’t go rapidly on your own, and that’s been shown time and again.

YOSIE: Three months ago…

VOORHEES: Can I respond to that?

MOYERS: Sure.

VOORHEES: Since he referred to the vinyl chloride story in the litigation, and I would say it would be fair for the viewer to think that the program was about concealment and secrecy. And what the viewer was not shown was that in each of the episodes that you portrayed in the program where you would show a document that says confidential or secret, what you failed to do was to show that shortly after that document was prepared, a study was published. For example, I’ll just give you few examples.

The Viola study in 1970, the first Italian researcher who found some signs of carcinogenity in laboratory animal experiments, and you showed a document that said this could potential be problematic and should be confidential. What you didn’t say is that Viola’s study on that subject was published in 1970, the next year after the confidential document. So the point is, that when we research was being done on these very subjects, research on… initially on laboratory animals, that the research was published and there was not one reference in that whole program to the published articles that followed each of these incidents that are referred to in the program. To me that’s a very misleading presentation.

YOSIE: Three months ago…

MOYERS: Let me just answer Mr. Voorhees. For one thing, it was because that Dr. Viola was going to publish his findings that the chemical association meeting took place to discuss what to do about it. And I was really astonished, Mr. Voorhees, in the materials you sent us before the broadcast which we examined thoroughly. You were very selective in what you gave us. You did not include in there the documents that show how the industry did not want to talk about it, Dr. Maltoni’s research, and made plans not to disclose that to NIOSH, even though NIOSH, the government agency, had asked for those… that information to be volunteered, and your industry did not do that. The documents make it clear that they did not talk about Dr. Maltoni’s argument. But that’s the past.

I would love to come back to this issue. Look, the people out there watching this thing, you know, we know our lives are better because of chemistry. But we also know that pediatricians and physicians like Dr. Landrigan are saying, we don’t know what this new combination is doing to us. So what is the question? What are the issues?

LANDRIGAN: I that’s the… excuse me, Terry. I think the issue, Bill, is that this is not something of the past. Many of the chemicals, for example, that were tested last week in that CDC report that was released to the nation on the 21st of March, are chemicals that reside…

MOYERS: That was the center for disease control, right?

LANDRIGAN: The center for disease control in Atlanta, that’s right.

Many of the chemicals which they tested, for example the pesticide products, are relatively short-lived chemicals. Those are chemicals, when they get into the body of a child, only stay there for a matter of weeks or at most a month or two, and then they’re gone.

So the chemicals that were measured by CDC in Americans are chemicals where the exposures are taking place today. And in response to your question, it’s absolutely true that children are the most vulnerable among us to those chemicals, and kids are vulnerable for two reasons. First of all, they take more chemicals into their body. They breathe more air. They drink more water. They eat more food pound for pound. So they take more chemicals into their body that are present in the air, on their food, in their water. And of course, kids play on the floor. They drop a lollipop on the rug. If there’s pesticide on that rug, they pick up the lollipop, they put the lollipop into their mouths and the pesticide gets in.

Then on top of that, besides being more heavily exposed, kids are biologically more vulnerable. I mean, anybody who has seen a little child– I’ve got a grandson who is just a bit over a year old– anybody who’s got a little child knows how precious and how vulnerable they are. Their brains are growing and developing. If a chemical like lead, like a pesticide, like PCB’s, like organic mercury gets into the brain of a baby during those early months of development, the consequences can be life-long.

YOSIE: Three months ago, the Department of Health and Human Services… Please, Bill, please, be fair.

LANDRIGAN: What really troubles me here is we don’t know… we simply do not know the long-term consequences of exposures in early life. As a pediatrician, as a parent, as a grandparent…

MOYERS: But what’s the public’s policy you’d like to see come out of this, and I would like to hear Terry Yosie say why the industry wouldn’t support that public policy?

LANDRIGAN: I think we need four things, four things only.

Number one, we need thorough independent testing of chemicals, including testing that looks at pediatric effects.

YOSIE: That’s underway.

LANDRIGAN: Number two, and it needs to be independent of the industry.

YOSIE: Colleagues… Mr. Cook’s colleagues in the environmental community are working directly with us. We just participated in a process with environmental groups and others to test compounds for their impact on children.

LANDRIGAN: Well, that’s… it just leaves…

YOSIE: There is an agreement in place to do just that.

LANDRIGAN: I’m glad. I noticed in the show itself that of promises were made, the results haven’t yet appeared. But the second thing that needs to be done is that we need to continue the nationwide testing of chemicals in the bloodstream of Americans that CDC has started. CDC, I understand…

YOSIE: We support that objective.

LANDRIGAN: And that’s good, that’s good.

YOSIE: We think the CDC report, which by the way, used technology that we helped develop. Those analytical methods that were used in your body and used on the recent CDC report are an outgrowth of our commitment to science to improve better analytical detection techniques. And so we support CDC’s continued efforts to learn more about the health status of the American people.

LANDRIGAN: Excellent. Number three, I think we need to work together. And this might actually be an area where the chemical industry and the environmental community and the academic community can work together. This is to support a national right-to-know initiative. For this nation, we ought to have the national equivalent of the Proposition 65 law that they have in California. Everybody in this country ought to be able to get good, accurate, unbiased information on every product they buy in the stores.

And fourthly, on the final need that I think we have to have in this country, is we need to have a more efficient, more effective process than we do today to get toxic chemicals off the market and to replace them with safer chemicals.

That’s what America’s kids need.

YOSIE: Two comments: One is, Mr. Landrigan, Dr. Landrigan, does raise the issue of what is the health status of children. Three months ago the Department of Health and Human Services, which includes the Center for Disease Control, issued a report. Let me read you a sentence in the very first paragraph of that report: “We’ve made life better for our children.” The Department of Health and Human Services, like the CDC, looks at the broad spectrum of issues that could potentially effect children’s health. And there is some very good news to report.

There are record child immunization rates. There’s a decline in youth drug use and smoking. There is a decline in teenaged mothers giving birth. There’s a decline in infant mortality. But even beyond children, cancer rates are down.

LANDRIGAN: Cancer death rates are down, cancer incidence rates are up, Terry.

YOSIE: But that’s an artifact of better reporting.

LANDRIGAN: No, it’s not.

YOSIE: Life expectancy rates in this country. We are living better and healthier, not only but because of the products we make but because people are being more sensible in terms of how they live and how they behave.

LANDRIGAN: The facts don’t support… some of what you’re saying is true, but it’s very selective.

YOSIE: I’m quoting to the CDC, Phil.

LANDRIGAN: You’re quoting part of a 30-page CDC report. Cancer death rates are down, but the number of new cases of cancer in children is up. I don’t know why they’re up, but since 1972, which is when we began to keep national records in this country, we have experienced a 42%… 41% increase in the incidents of brain cancer, the number of cases of brain cancer per thousand children. That is not a reporting artifact. We weren’t missing 40% of brain cancers 30 years ago when I started my pediatric career. We just weren’t. In young men 15-30, there has been a 68% increase in the incidents of testicular cancer.

Now, you’re quite right, American children today live longer. They live longer because we have conquered most of the infectious diseases in this country. But the rates of asthma have doubled.

YOSIE: What are the principal health risks that children today. To some extent they do come from environmental factors, but domestic violence…

LANDRIGAN: Oh, the principal cause of hospitalization of American children is…

YOSIE: …lack of access to healthcare, a number of other factors…

MOYERS: Are those not involuntary, but chemicals in our food and chemicals in our toys are not something that people ask for, they just happen, as you said I think, or McCally said in the interview, suddenly we’ve got all these chemicals in our body.

VOORHEES: These are products that have been very carefully scrutinized by the scientific community, by government agencies, and as a result…

YOSIE: Let me make one point if I may, one point, if I may.

LANDRIGAN: Why is there…

YOSIE: Phil made the point that we need to take the compounds off the market. That has been tried in many countries and disaster has resulted. The nation of Peru stopped chlorinating its water supply. Chlorine is one of our major products. What happened after that event? A cholera epidemic broke out and over 10,000 people in Peru and Latin America lost their life.

LANDRIGAN: And in this country we took tetraethyl lead out of gasoline American’s blood levels have declined 99%.

YOSIE: And proponents of removing chlorine are saying that ought to be done in this country. There are ten to 25 million people perishing because of a lack of a drinking water supply.

LANDRIGAN: In this country, over the vigorous objection of the Ethyl Corporation, we removed tetraethyl lead from gasoline. The average blood lead level in American children has declined by 90%, and the average IQ of American babies has increased by three points.

YOSIE: You and I were on the same side of that debate when I served as the official of the environmental protection agency.

LANDRIGAN: When you were at EPA.

YOSIE: When I was at EPA.

COOK: Yeah, but the companies you represent…

YOSIE: You and I were on the same side of that debate, and we still are.

MOYERS: What was that, Ken?

COOK: The companies you represent weren’t, and that’s the point. If you look at these documents which we now have– and let me just put in a plug, ewg.org, you can read 40,000 pages of them going back to 1945 now.

YOSIE: And we will correct those in abouttradesecrets.org.

MOYERS: What’s your web site?

YOSIE: Everybody’s got a web site. Ours is abouttradesecrets– that’s one word– abouttradesecrets.org.

MOYERS: And yours is…

LANDRIGAN: Childenvironment.org.

MOYERS: Covington & Burling?

VOORHEES: Well, we have a law firm web site, but I’m not sure people…

MOYERS: (laughs) Ours is pbs.org.

It’s only fair that you get a chance to answer this question, because as I’ve said to you, investigative journalism is not a collaboration between the journalist and the subject, and I did lay out there, Sherry Jones and I laid out, the record of the industry and opposing right to no initiative.

Why has, in every case that I can find, why has your industry opposed citizens effort to use the right to know initiative and every right to know efforts?

YOSIE: I think you have your facts wrong.

MOYERS: Tennessee, Hawaii, California, Ohio, Illinois, Massachusetts.

YOSIE: We supported the amendment, the Superfund statute, in 1986, creating the Toxic Release Inventory. We supported in 1990, the amendment of the Clean Air Act so that information would be made available to communities about chemicals that were being used in their neighborhoods. We supported, with Environmental Defense, the complete and total disclosure of any testing results going on with our current agreement with them. We had been a strong supporter of right to know, and here’s why.

We have had over the last dozen years, a program that has instituted over 300 community advisory panels wherever this industry is located in this country. We have learned a great deal from listening to communities where we play a major part. One of the greatest testimonials that you hear about this industry is from people who live near it, because they have seen the very direct health and environmental progress and the emissions reductions that result from our industry. When they have a question about plant safety or noise levels or environmental emissions, they have direct access to the plant manager. They have access to go inside the plant gates and see what’s going on.

COOK: I’ve talked to an awful lot of people…

YOSIE: That is why we have 60% decline in emissions over the last decade, the best of any American industry.

COOK: Well, you almost make it sound as if you volunteered to do that, and you did not.

YOSIE: We supported those measures.

COOK: Listen, what you selectively may have supported, everyone can now read what decisions you made and how you made them to take a stand on clean air and clean water and drinking water, and it’s… I respectfully disagree, it is not as you describe it. No, what these communities are often left with is just asking a plant manager, “Can you tell us?” No authority, no power under law to actually compel that information to come forward. And to get back to the testing point, I just want to, because there would be some confusion…

MOYERS: We have about 45 seconds.

COOK: There will be some confusion out there. If these chemicals are so well tested, then how come you had to come forward with a program just two years ago to voluntarily test the most widely used ones if they were tested? Some of them have been used for decades.

YOSIE: Because we’re a responsible industry. Because we’re always seeking answers to question. We’re a science-based…

COOK: About 40 years late.

YOSIE: We’re a science-based industry, and by nature we are asking these questions. There are a million men and women who work in this industry who apply chemistry to make a variety of products and services. I’m very proud to represent them here tonight, and as we close this broadcast, I want to thank them for the contribution they’ve made to society. They’ve made America a better, healthier and safer society. And to the viewing audience, I want to say that we are committed to continuing to improve our environmental health and safety performance. I think you all know that what happened 40 years ago is no reflection of the kind of industry that we represent today.

MOYERS: We’re going to let you have the last word.

YOSIE: Thank you.

MOYERS: Thank you very much, Terry Yosie, thank you, Mr. Voorhees, thank you Dr. Landrigan, thank you Ken Cook.

I’m Bill Moyers. Thanks for watching. Good night.

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House Oversight and Government Reform Committee Investigation into Johnson and Johnson’s Recall of Children’s Tylenol and Other Children’s Medicines

Statement of
Joshua M. Sharfstein, M.D.
Principal Deputy Commissioner
U.S. Food and Drug Administration
Department of Health and Human Services

Before the
Committee on Oversight and Government Reform
U.S. House of Repersentatives

May 27, 2010
Introduction
Mr. Chairman and Members of the Committee, I am Joshua M. Sharfstein, M.D., Principal Deputy Commissioner, U.S. Food and Drug Administration (FDA or the Agency), which is an Agency of the Department of Health and Human Services. Thank you for the opportunity to discuss the Agency’s regulation of drug manufacturing, our oversight of McNeil Consumer Healthcare, LLC (McNeil), and lessons learned from the ongoing investigation into quality concerns at McNeil.

FDA Oversight of Drug Manufacturing
Under the Federal Food, Drug, and Cosmetic Act, FDA is charged with, among other things, ensuring that drugs marketed in the United States are safe and effective, and are manufactured in accordance with current Good Manufacturing Practice (cGMP).

The cGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations are intended to ensure purity, potency, and quality of drug products, and to prevent unsafe products from reaching consumers.

Under the cGMP regulations, each manufacturer sets specifications for its own products for such factors as potency, stability and purity, and puts in place a quality system that ensures those specifications are met. Critical to the cGMP process is that a company must meet its own standards.

A violation of cGMP does not necessarily mean that a product is hazardous to the public. It does indicate, however, a breakdown in a manufacturer’s quality system and is an indication that a company needs to take effective steps to fix the problem promptly.

FDA inspects facilities to ensure compliance with cGMP standards. These inspections occur on average for domestic facilities every two to three years. We increase the frequency of inspections for facilities when warranted by past problems or by products that are difficult to manufacture or are especially high risk.

When on site, FDA inspectors identify gaps in manufacturing standards and discuss with companies how they can fix them. Firms may choose to recall products when there are cGMP violations, especially when those violations have a significant impact on product quality or safety.

For drugs, patterns of non-compliance or non-compliance that put the public’s health at risk leads to appropriate enforcement action by the Agency, including warning letters, seizures, injunctions and criminal prosecution.

Oversight of McNeil Consumer Healthcare, LLC (McNeil)
McNeil makes a variety of over-the-counter (OTC) products for the U.S. market from four manufacturing facilities in the United States and Canada. Over the last several years, FDA has had growing concerns about the quality of the company’s manufacturing process. These concerns have led to a number of unsatisfactory inspections and consumer recalls. FDA has inspected the company’s facilities with an increased frequency, and in February 2010, the Agency took the extraordinary step of convening a meeting with the management of the parent company, Johnson & Johnson, to express concern about a pattern of non-compliance.

Prior to 2009. Before 2009, FDA investigators identified several problems with cGMP compliance at facilities run by McNeil. These problems included laboratory controls, equipment cleaning processes, and a failure to investigate identified problems. The company generally fixed the specific problems, and the Agency inspected the firm regularly.

Spring/Summer 2009. At its Fort Washington facility, McNeil makes a wide variety of OTC products, including a large number of OTC liquid products for children.

In May and June 2009, FDA identified several cGMP violations, including McNeil’s failure to meet its own standard for quality in one of the ingredients in OTC liquids.

McNeil’s standard for this ingredient, known as microcrystalline cellulose, required that there be no gram negative bacteria. McNeil purchased the cellulose in partial lots that had not tested positive for this objectionable bacteria. The vendor tested other partial lots from the same large master lot and found a certain gram negative bacteria called B. cepacia. According to cGMP standards, McNeil should not have used any partial lots from this master lot.

In reviewing the situation, FDA scientists concluded that the risk to the public was remote. All of the drums used tested negative for the bacteria B. cepacia, all of the final product tested negative, and FDA agreed with the company’s assessment that this bacteria would be very unlikely to grow in the final product.

Yet, because the company had not kept to its standard, it represented a cGMP violation, and the company initiated a recall of almost eight million bottles of finished product in August 2009.

Fall 2009. At its Las Piedras, Puerto Rico, facility, McNeil makes a large number of OTC pills for the U.S. market.

In the fall of last year, FDA became aware that McNeil had received reports of products from this facility having a musty odor. Yet, McNeil had not fully investigated these reports for about a year and did not notify FDA despite the requirement that such reports be referred to the Agency within three days.

FDA inspectors urged McNeil to conduct a complete investigation, which eventually identified the source of the odor to be a chemical, called 2,4,6-Tribromoanisole or TBA, which was in the air because of a pesticide used on the wood of the pallets used to store empty medication bottles. McNeil initiated a series of recalls as the scope of the problem became clear.

The risk posed to the public by this problem included potential temporary, non-serious gastrointestinal reactions – including nausea, stomach pain, vomiting, or diarrhea. Very little is known about the chemical TBA, but in the small quantities transferred to the products, it is not thought to pose a serious risk for long-term health problems.

On January 15, 2010, FDA issued a warning letter to McNeil expressing serious concerns about the company’s control over the quality of its drugs and the company’s failure to aggressively investigate and correct quality problems. This letter identified significant violations of the cGMP regulations. FDA noted that neither upper management at Johnson & Johnson nor at McNeil assured timely investigation and resolution of the issues.

January and February 2010. In early 2010, FDA conducted focused inspections of McNeil at both the Las Piedras and Fort Washington facilities to follow up on a reported problem. The report identified a 6-year-old child who died. Prior to his death, the child had been given several products manufactured by McNeil at these facilities. FDA tested the products the child had taken for potential contamination, and all results were negative. Based on the results of the testing and the results of the inspection, FDA did not find evidence to link the products to the child’s death.

February 2010. On February 19, 2010, senior compliance staff from FDA’s Center for Drug Evaluation and Research and from FDA’s field organization met with senior officials from McNeil and its parent company, Johnson & Johnson. Attendees included the President of McNeil, the Company Group Chairman for OTC at Johnson & Johnson, as well as a number of Quality Assurance executives from both companies.

This was an extraordinary meeting. FDA requested that senior officials from Johnson & Johnson attend the meeting so they would be on notice regarding FDA’s rising concerns about whether McNeil’s corporate culture supported a robust quality system to ensure the purity, potency and safety of its products. FDA also raised concerns about Johnson & Johnson’s oversight of McNeil due to recent multiple recalls of McNeil products and recent warning letters FDA had issued to both McNeil and its parent company, Johnson & Johnson. Based on the Fort Washington and Las Piedras inspections in 2009 as well as the firm’s recent compliance history, FDA expressed its significant concern that there was a pattern of conduct including failure to report material information to FDA in a timely manner, miscalculating and/or misstating risks and benefits of their products, and reactive vs. proactive approaches to product quality problems. FDA told the company’s leadership that significant, immediate steps were needed to address issues of compliance and quality, especially in investigating product quality issues so that the company could take preventive action to avoid problems.

The Agency learned that McNeil was taking several major steps to address these issues, including implementing management reporting structure changes, hiring new managers, and engaging a third party manufacturing consultant. FDA indicated that it would continue to monitor closely and consider further action, and that it was concerned about whether the company’s corporate culture was appropriately focused on product quality issues.

April 2010. In April, FDA inspectors returned to McNeil’s Fort Washington facility. This inspection was scheduled sooner than usual due to McNeil’s recent history of compliance problems, including numerous recalls and cGMP deficiencies discovered in the June 2009 Fort Washington inspection, which had a significant impact on the scheduling of the April 2010 inspection.

Days before the inspectors arrived, McNeil shut down manufacturing because of manufacturing issues, including particulates found in a number of liquid medications. These particulates included acetaminophen, cellulose, nickel, and chromium. FDA inspectors identified a range of cGMP violations. These included the company failing to meet its own specifications for bacteria and particulates and, for one Tylenol product, the possibility of higher than expected concentrations of Tylenol per dropper.

In reviewing the situation, FDA scientists concluded that the risk posed to the public by these problems was remote. FDA did not find evidence that McNeil used raw materials that its tests found to be positive for bacterial contamination and all lots of finished product were tested by McNeil and found negative for bacterial contamination. The particulates would be expected to pass through the gastrointestinal tract. While there was a potential for higher concentrations of Tylenol per dropper, none of the final products released for sale tested with high levels. In addition, the increase in potency would not be expected to cause adverse effects.

Although the public health risk from these quality problems is low, these problems should never have occurred, and the cGMP failures at the facility that caused them were unacceptable. Following cGMP requirements assures that products are consistent in their safety and effectiveness and failure to follow those procedures undermines consumer confidence. On April 30, 2010, McNeil announced a voluntary recall of over 136 million bottles of liquid infants’ and children’s products.

Next Steps in FDA Oversight of McNeil

Based on the pattern of concerns found at McNeil’s facilities, FDA is working with the company to address its systemic quality issues. The Agency is closely monitoring the implementation of a corrective action plan developed by McNeil that includes significant enhancements to its quality system, organizational changes, and senior management oversight.

FDA will continue to investigate issues related to the Fort Washington facility including oversight related to renewal of manufacturing operations at that facility, to evaluate the facility’s suppliers, and evaluate the compliance of all other McNeil facilities. FDA will also take steps to help ensure that when the facility begins manufacturing again it will be able to produce safe products. FDA is also considering additional enforcement actions against the company for its pattern of non-compliance which may include seizure, injunction or criminal penalties.

Adverse Event Evaluation
It is understandable that many Americans, hearing about these large recalls, would wonder whether or not their children were put at risk. In assessing this question, FDA considers two basic sources of information – first, our assessment of the manufacturing problems themselves, and second, adverse event reports to the Agency.

As I discussed earlier, FDA analyzed the various manufacturing problems. Based on the circumstances in each case, our experts believe the risk for any child in the United States was remote.

FDA has also looked at adverse events reported to the Agency. FDA receives these reports and often requests and reviews medical records, coroner’s reports, and other supplementary data sources.

When we have adequate information about a case, the Agency reviews these reports to determine what role, if any, the medication played in the development of an adverse event. We can find that the medication likely had no role in the adverse event, that the medication’s activity as a drug could have caused a serious side effect, or that a quality problem may have contributed to the outcome.

All drugs have side effects, and some of the McNeil reports may reflect the side effects of OTC medications. Other reports appear unrelated to the medications.

So far, FDA has no cases with evidence that a product quality issue contributed to a significant adverse health outcome. We are continuing to receive information about certain cases and we will update the public and the Committee should our assessment change.

Lessons Learned
Every investigation presents an opportunity for FDA to improve our effectiveness in protecting the public health. One lesson to be drawn from the McNeil story is that it is important for the Agency to even more fully consider the corporate structure when investigating and enforcing the law. FDA will be developing new procedures to use what we learn at one facility in guiding our inspections of other facilities run by the same company.

FDA is also using these events as part of an ongoing review of our recall process. FDA has already made significant changes to its approach to recalls when there are urgent, life-threatening product quality concerns. For example, in recent months, FDA has moved aggressively to support several urgent food recalls. FDA is now looking at our process for clear expectations and standards with respect to other types of recalls, such as those undertaken by McNeil.

We will continue to work with Congress to secure additional authorities that could assist us in assuring product quality and acting more quickly when product quality issues occur.
FDA will also be considering enforcement actions in this case as part of the Agency’s ongoing changes in enforcement. FDA Commissioner Dr. Margaret Hamburg has called for FDA’s enforcement to be “vigilant, strategic, quick, and visible.” A range of activities are underway at the Agency to bring this vision to reality, including strengthening our criminal enforcement of FDA’s laws.

As we continue these efforts, as well as our other regulatory work, we will focus on entire companies and their systems in addition to focusing on specific violations, individuals, and sites, much as we are doing in the McNeil situation.

Conclusion
Thank you for the opportunity to explain FDA’s oversight of drug manufacturing and our engagement with McNeil. I look forward to your questions.

“Gentle on little tummies.. When it comes to reducing fever or relieving pain in infants, INFANTS’ TYLENOL® has been the brand recommended most by pediatricians for the last 20 years. INFANTS’ TYLENOL® works differently than other pain and fever medicines. It also won’t upset little stomachs…. anhydrous citric acid, butylparaben, D&C red no. 33, FD&C Blue no.1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, SUCRALOSE, xanthan gum.”

The Search For Sweet by Burkhard Bilger for The New Yorker – May 22, 2006

“The substance in the flask seemed to have all the makings of an excellent insecticide. It was a fine crystaline powder and its molecules were full of chlorine atoms, like DDT. ..by taking an eye-dropper full of sulfuryl chloride – a highly toxic chemical – and adding it to a sugar solution, one drop at a time. In the violent reaction that followed, a wholly new compound was born: 1′, 4,6,6′-tetrachloro-1′,4,6,6′-tetra-deoxygalactosucrose. “It isn’t of any use as an insecticide,” Hough told me recently, “That was tested.” But it has proven useful as a food. In its pure form, it is known as sucralose. When mixed with fillers and sold in bright yellow sachets, it’s known as Splenda, the best-selling artificial sweetener in America.”

Sucralose was declared safe by the Food and Drug Administration in 1998, but most of the taste researchers I talked to won’t eat it. “I look at that structure and I have an irrational fear of it,” one of them said.”

http://archives.newyorker.com/?i=2006-05-22#folio=040

J Toxicol Environ Health A. 2008;71(21):1415-29. doi: 10.1080/15287390802328630.
Splenda alters gut microflora and increases intestinal p-glycoprotein and cytochrome p-450 in male rats.
Abou-Donia MB1, El-Masry EM, Abdel-Rahman AA, McLendon RE, Schiffman SS.
Author information

Abstract
Splenda is comprised of the high-potency artificial sweetener sucralose (1.1%) and the fillers maltodextrin and glucose. Splenda was administered by oral gavage at 100, 300, 500, or 1000 mg/kg to male Sprague-Dawley rats for 12-wk, during which fecal samples were collected weekly for bacterial analysis and measurement of fecal pH. After 12-wk, half of the animals from each treatment group were sacrificed to determine the intestinal expression of the membrane efflux transporter P-glycoprotein (P-gp) and the cytochrome P-450 (CYP) metabolism system by Western blot. The remaining animals were allowed to recover for an additional 12-wk, and further assessments of fecal microflora, fecal pH, and expression of P-gp and CYP were determined. At the end of the 12-wk treatment period, the numbers of total anaerobes, bifidobacteria, lactobacilli, Bacteroides, clostridia, and total aerobic bacteria were significantly decreased; however, there was no significant treatment effect on enterobacteria. Splenda also increased fecal pH and enhanced the expression of P-gp by 2.43-fold, CYP3A4 by 2.51-fold, and CYP2D1 by 3.49-fold. Following the 12-wk recovery period, only the total anaerobes and bifidobacteria remained significantly depressed, whereas pH values, P-gp, and CYP3A4 and CYP2D1 remained elevated. These changes occurred at Splenda dosages that contained sucralose at 1.1-11 mg/kg (the US FDA Acceptable Daily Intake for sucralose is 5 mg/kg). Evidence indicates that a 12-wk administration of Splenda exerted numerous adverse effects, including (1) reduction in beneficial fecal microflora, (2) increased fecal pH, and (3) enhanced expression levels of P-gp, CYP3A4, and CYP2D1, which are known to limit the bioavailability of orally administered drugs.

Splenda: The Artificial Sweetener that Explodes Internally
By: Shane Ellison, MS for The People’s Chemist

“Splenda contains the drug sucralose. This chemical is 600 times sweeter than sugar. To make sucralose, chlorine is used. Chlorine has a split personality. It can be harmless or it can be life threatening.
In combo with sodium, chlorine forms a harmless “ionic bond” to yield table salt. Sucralose makers often highlight this worthless fact to defend its’ safety. Apparently, they missed the second day of Chemistry 101 – the day they teach “covalent” bonds.
When used with carbon, the chlorine atom in sucralose forms a “covalent” bond. The end result is the historically deadly “organochlorine” or simply: a Really-Nasty Form of Chlorine (RNFOC).
Unlike ionic bonds, covalently bound chlorine atoms are a big no-no for the human body. They yield insecticides, pesticides, and herbicides – not something you want in the lunch box of your precious child. It’s therefore no surprise that the originators of sucralose, chemists Hough and Phadnis, were attempting to design new insecticides when they discovered it! It wasn’t until the young Phadnis accidentally tasted his new “insecticide” that he learned it was sweet. And because sugars are more profitable than insecticides, the whole insecticide idea got canned and a new sweetener called Splenda got packaged.
To hide its dirty origin, Splenda pushers assert that sucralose is “made from sugar so it tastes like sugar.” Sucralose is as close to sugar as Windex is to ocean water.”

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I have stumbled upon one factor that has been overlooked in Autism research and infant and children’s health. Pediatricians often recommend giving infants and children Tylenol and Mortin (for infants over 6 months) for pain management prior or just after they’ve received a vaccine. What public and health care professionals do not know is that there is an excipient in the infant and children Tylenol and some of the Motrin formulations that contains a chlorocarbon (or organochloride) utilized as the sweetening agent.


To access Children’s Tylenol ingredient list click here.

Sucralose or what is commonly known as Splenda is the organochloride or chlorocarbon utilized in the suspension fluids. The invention of sucralose or Splenda was documented in the New Yorker article, “The Search For Sweet,” by Burkhard Bilger – May 22, 2006.

The substance in the flask seemed to have all the makings of an excellent insecticide. It was a fine crystaline powder and its molecules were full of chlorine atoms, like DDT. ..by taking an eye-dropper full of sulfuryl chloride – a highly toxic chemical – and adding it to a sugar solution, one drop at a time. In the violent reaction that followed, a wholly new compound was born: 1′, 4,6,6′-tetrachloro-1′,4,6,6′-tetra-deoxygalactosucrose. “It isn’t of any use as an insecticide,” Hough told me recently, “That was tested.” But it has proven useful as a food. In its pure form, it is known as sucralose. When mixed with fillers and sold in bright yellow sachets, it’s known as Splenda, the best-selling artificial sweetener in America.”

Sucralose was declared safe by the Food and Drug Administration in 1998, but most of the taste researchers I talked to won’t eat it. “I look at that structure and I have an irrational fear of it,” one of them said.

To access this article view on the link below. The New Yorker does charge a small fee to access this archived issue.


The Search For Sweet by Burkhard Bilger for The New Yorker – May 22, 2006


THE LETHAL SCIENCE OF SPLENDA, A POISONOUS CHLOROCARBON by James Bowen, M.D.

James Bowen explains the impacts of Splenda (sucralose).

“Splenda/sucralose is simply chlorinated sugar; a chlorocarbon. Common chlorocarbons include carbon tetrachloride, trichlorethelene and methylene chloride, all deadly. Chlorine is nature’s Doberman attack dog, a highly excitable, ferocious atomic element employed as a biocide in bleach, disinfectants, insecticide, WWI poison gas and hydrochloric acid.

“Sucralose is a molecule of sugar chemically manipulated to surrender three hydroxyl groups (hydrogen + oxygen) and replace them with three chlorine atoms. Natural sugar is a hydrocarbon built around 12 carbon atoms. When turned into Splenda it becomes a chlorocarbon, in the family of Chlorodane, Lindane and DDT.

“It is logical to ask why table salt, which also contains chlorine, is safe while Splenda/sucralose is toxic? Because salt isn’t a chlorocarbon. When molecular chemistry binds sodium to chlorine to make salt carbon isn’t included. Sucralose and salt are as different as oil and water.

“Unlike sodium chloride, chlorocarbons are never nutritionally compatible with our metabolic processes and are wholly incompatible with normal human metabolic functioning. When chlorine is chemically reacted into carbon-structured organic compounds to make chlorocarbons, the carbon and chlorine atoms bind to each other by mutually sharing electrons in their outer shells. This arrangement adversely affects human metabolism because our mitochondrial and cellular enzyme systems are designed to completely utilize organic molecules containing carbon, hydrogen, oxygen, nitrogen, and other compatible nutritional elements.

“By this process chlorocarbons such as sucralose deliver chlorine directly into our cells through normal metabolization. This makes them effective insecticides and preservatives. Preservatives must kill anything alive to prevent bacterial decomposition.”

Dr. Bowen believes ingested chlorocarbon damage continues with the formation of other toxins: “Any chlorocarbons not directly excreted from the body intact can cause immense damage to the processes of human metabolism and, eventually, our internal organs. The liver is a detoxification organ which deals with ingested poisons. Chlorocarbons damage the hepatocytes, the liver’s metabolic cells, and destroy them.

In test animals Splenda produced swollen livers, as do all chlorocarbon poisons, and also calcified the kidneys of test animals in toxicity studies. The brain and nervous system are highly subject to metabolic toxicities and solvency damages by these chemicals. Their high solvency attacks the human nervous system and many other body systems including genetics and the immune function. Thus, chlorocarbon poisoning can cause cancer, birth defects, and immune system destruction. These are well known effects of Dioxin and PCBs which are known deadly chlorocarbons.”

Dr. Bowen continues: “Just like aspartame, which achieved marketplace approval by the Food and Drug Administration when animal studies clearly demonstrated its toxicity, sucralose also failed in clinical trials with animals. Aspartame created brain tumors in rats. Sucralose has been found to shrink thymus glands (the biological seat of immunity) and produce liver inflammation in rats and mice.

“In the coming months we can expect to see a river of media hype expounding the virtues of Splenda/sucralose. We should not be fooled again into accepting the safety of a toxic chemical on the blessing of the FDA and saturation advertising. In terms of potential long-term human toxicity we should regard sucralose with its chemical cousin DDT, the insecticide now outlawed because of its horrendous long term toxicities at even minute trace levels in human, avian, and mammalian tissues.

Researchers have known for a long time that chlorinated compounds impact liver functionality. Rachel Carson discussed chlorinated compounds in Silent Spring. She also discusses Methoxychlor, another organochlorine once used as an insecticide, and it’s toxicity when combined with other chlorinated compounds like DDT.

One of the most significant facts about the chlorinated hydrocarbon insecticides is their effect on the liver. Of all the organs in the body the liver is most extraordinary. In its versatility and in the indispensable nature of its functions it has no equal. It presides over so many vital activities that even the slightest damage is fraught with serious consequences. Not only does it provide bile for the digestion of fats, but because of its location and the special circulatory pathways that converge upon it the liver receives blood directly from the digestive tract and is deeply involved in the metabolism of all the principal foodstuffs. It stores sugar in the form of glycogen and releases it as glucose in carefully measured quantities to keep the blood sugar at a normal level. It builds body proteins, including some essential elements of blood plasma concerned with blood-clotting. It maintains cholesterol at its proper level in the blood plasma, and inactivates the male and female hormones when they reach excessive levels. It is a storehouse of many vitamins, some of which in turn contribute to its own proper functioning.

Without a normally functioning liver the body would be disarmed–defenseless against the great variety of poisons that continually invade it. Some of these are normal by-products of metabolism, which the liver swiftly and efficiently makes harmless by withdrawing their nitrogen. But poisons that have no normal place in the body may also be detoxified. The “harmless” insecticides malathion and methoxychlor are less poisonous than their relatives only because a liver enzyme deals with them, altering their molecules in such a way that their capacity for harm is lessened. In similar ways the liver deals with the majority of the toxic materials to which we are exposed.

Our line of defense against invading poisons or poisons from within is now weakened and crumbling. A liver damaged by pesticides in not only incapable of protecting us from poisons, the whole range of its activities may be interfered with. Not only are the consequences far-reaching, but because of their variety and the fact that they may not immediately appear they may not be attributed to their true cause…..

The effect of a chemical of supposedly innocuous nature can be drastically changed by the action of another; one of the best examples is a close relative of DDT called methoxychlor (Actually, methoxychlor may not be as free from dangerous qualities as it is generally said to be, for recent work on experimental animals shows a direct action on the uterus and a blocking effect on some of the powerful pituitary hormones–reminding us again that these are chemicals with enormous biological effect. Other work shows that methoxychlor has a potential ability to damage the kidneys.) Because it is not stored to any great extent when given alone, we are told that methoxychlor is a safe chemical. But this is not necessarily true. If the liver has been damaged by another agent, methoxychlor is stored in the body at 100 times its normal rate, and will then imitate the effects of DDT with long-lasting effects on the nervous system. Yet the liver damage that brings this about might be so slight as to pass unnoticed. It might have been the result of any number of commonplace situations–using another insecticide, using a cleaning fluid containing carbon tetrachloride, or taking one of the so-called tranquilizing drugs, a number (but not all) of which are chlorinated hydrocarbons and possess power to damage the liver.

This raises very serious questions. Infant and children’s pharmaceutical excipients, inactives, or inerts (Take your pick on the term) need serious review. The Johnson & Johnson McNeil Fort Washington Facility is now closed. The FDA inspection review showed chronic failures in quality and consistency of the oral suspension formulations. This is the same facility where they make sucralose and utilized it in their infant and children’s Tylenol and Motrin formulations. Johnson & Johnson’s McNeil failed to understand the potential implications of utilizing a chlorocarbon (or organochloride) as a sweetener in infant and children’s pharmaceuticals. Parents give their infants and children Tylenol and Motrin products to help relieve their pain and suffering not knowing that something in that product may have serious long term health consequences. Has Splenda or sucralose ever been tested for its synergistic properties? Could sucralose impair liver functionality and cause other poisons or toxins to be absorbed at an accelerated rate? Those are the questions that need immediate answers.

The FDA inspection report is deeply disturbing in light of this information.

Observation 3
Control procedures fail to include adequacy of mixing to assure uniformity and homogeneity.

Control procedures used did not validate the manufacturing processes that caused variability in the characteristics of the drug product. For examples, the agitation speeds and time to reach [Blacked out] in the hold tank during processing of the [blacked out] super potent batches that failed APAP (end of run) assays, [blacked out] released batches, and the demonstration batch. The firm did not demonstrate the adequacy of mixing to assure uniformity and homogeneity for Infant’s Dye-Free Tylenol Suspension Drops, Formula [blacked out] using a [blacked out] batch in a [blacked out] hold tank. Agitation and tank levels with [blacked out] the amount of liquid) in a [blacked out] hold tank were evaluated with one demonstration bulk batch, lot ]blacked out] packaged as lot [blacked out] The [blacked out] batches into [blacked out] hold tanks used [blacked out] and the agitator was shut off at [blacked out] using the weight of [blacked out] for the [blacked out] batch in a [blacked out] hold tank. With the [blacked out] super potent batches, APAP concentrated at the end run when the agitator was shut off at [blacked out] in the tank).

To review the complete inspection report click on the link below to review the PDF.


Food & Drug Administration Facility Inspection Results for McNeil Consumer Healthcare, Division of McNeil-PPC, Inc.

The inspection results are also available here at this site.
https://renchemista.wordpress.com/2010/07/13/fda-facility-inspection-results-for-mcneil-ppc-fort-washington-pa-4192010-4302010-childrens-tylenol-motrin-recalls/

J Toxicol Environ Health A. 2008;71(21):1415-29. doi: 10.1080/15287390802328630.
Splenda alters gut microflora and increases intestinal p-glycoprotein and cytochrome p-450 in male rats.
Abou-Donia MB1, El-Masry EM, Abdel-Rahman AA, McLendon RE, Schiffman SS.
Author information

Abstract
Splenda is comprised of the high-potency artificial sweetener sucralose (1.1%) and the fillers maltodextrin and glucose. Splenda was administered by oral gavage at 100, 300, 500, or 1000 mg/kg to male Sprague-Dawley rats for 12-wk, during which fecal samples were collected weekly for bacterial analysis and measurement of fecal pH. After 12-wk, half of the animals from each treatment group were sacrificed to determine the intestinal expression of the membrane efflux transporter P-glycoprotein (P-gp) and the cytochrome P-450 (CYP) metabolism system by Western blot. The remaining animals were allowed to recover for an additional 12-wk, and further assessments of fecal microflora, fecal pH, and expression of P-gp and CYP were determined. At the end of the 12-wk treatment period, the numbers of total anaerobes, bifidobacteria, lactobacilli, Bacteroides, clostridia, and total aerobic bacteria were significantly decreased; however, there was no significant treatment effect on enterobacteria. Splenda also increased fecal pH and enhanced the expression of P-gp by 2.43-fold, CYP3A4 by 2.51-fold, and CYP2D1 by 3.49-fold. Following the 12-wk recovery period, only the total anaerobes and bifidobacteria remained significantly depressed, whereas pH values, P-gp, and CYP3A4 and CYP2D1 remained elevated. These changes occurred at Splenda dosages that contained sucralose at 1.1-11 mg/kg (the US FDA Acceptable Daily Intake for sucralose is 5 mg/kg). Evidence indicates that a 12-wk administration of Splenda exerted numerous adverse effects, including (1) reduction in beneficial fecal microflora, (2) increased fecal pH, and (3) enhanced expression levels of P-gp, CYP3A4, and CYP2D1, which are known to limit the bioavailability of orally administered drugs.

http://www.ncbi.nlm.nih.gov/pubmed/18800291

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Oversight & Government Reform Committee Investigation regarding Recalls.


Food & Drug Administration Facility Inspection Results for McNeil Consumer Healthcare, Division of McNeil-PPC, Inc.

US Customhouse, Rm 900 2nd & Chestnut St
Philadelphia, PA 19106
(215) 597 – 4390 Fax: (215) 597 – 0875
Industry Information: http://www.fda.gov/oc/industry

To: Hakan Erdemir, Vice President of Operations

Firm name – McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.
Address – 7050 Camp Hill Road
Fort Washington, PA 19034
FEI Number – 2510184

Dates of Inspection 4/19/2010 – 4/30/2010

This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions please contact FDA at the phone number and address above.

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

QUALITY SYSTEM

OBSERVATION 1

The responsibilities and procedures applicable to the quality control unit are not fully followed.

Specifically,

a. The Quality Control Unit (QA) authorities most responsible for overseeing daily operations at the Fort Washington facility did not ensure that the responsibilities of the Analytical, Microbiological, Compliance, and Quality Assurance departments were enforced for rejection and withholding from approved any raw material component that contained “known” contamination of gram negative organisms. Raw material [blacked out], lots [blacked out] had known contamination with gram negative organisms and were approved for use to manufacture several finished lots of Children’s and Infant’s Tylenol drug products, which remain within expiration date(s) on the market. Responsible firm officials did not adhere to GMP regulations per [blacked out] for [blacked out] in that no Quality Notification was implemented regarding the rejection of contaminated lots of [blacked out]

b. QA and Compliance Department overall responsibilities per the firm’s [blacked out] is deficient as follows: It does not maintain adequate laboratory facilities for the testing and approval (or rejection) of components and drug products; it neglects review and approval validation protocols regarding changes in product processes and equipment to determine when revalidation is or should be warranted; it is default in investigations, tracking, trending and maintenance of consumer complaint follow-up; and it lacks trending of products, components (i.e. water), and complaints to demonstrate a broad perspective to assure plant conformance with CGMPs.

OBSERVATION 2

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to posses.

Specifically,

Lack of process validation for the manufacture of Infant’s Dye-Free Tylenol Suspension Drops, Cherry, Formula [blacked out] 80mg/0.8 mL. The compounding and transfer of the [blacked out] batch size suspension to the [blacked out] hold tank in not in a “state of control.” The firm did not effectively evaluate the change in the manufacturing process (agitation and tank level time to shut off of agitator) when the batch size was increased from [blacked out] into a [blacked out] hold tank and/or when the hold tank size used for a [blacked out] batch was decreased from a [blacked out] to a [blacked out] hold tank.

OBSERVATION 3

Control procedures fail to include adequacy of mixing to assure uniformity and homogeneity.

OBSERVATION 4

Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

Specifically,

Control procedures used did not validate the manufacturing processes that caused variability in the characteristics of the drug product. For examples, the agitation speeds and time to reach [Blacked out] in the hold tank during processing of the [blacked out] super potent batches that failed APAP (end of run) assays, [blacked out] released batches, and the demonstration batch. The firm did not demonstrate the adequacy of mixing to assure uniformity and homogeneity for Infant’s Dye-Free Tylenol Suspension Drops, Formula [blacked out] using a [blacked out] batch in a [blacked out] hold tank. Agitation and tank levels with [blacked out] the amount of liquid) in a [blacked out] hold tank were evaluated with one demonstration bulk batch, lot ]blacked out] packaged as lot [blacked out] The [blacked out] batches into [blacked out] hold tanks used [blacked out] and the agitator was shut off at [blacked out] using the weight of [blacked out] for the [blacked out] batch in a [blacked out] hold tank. With the [blacked out] super potent batches, APAP concentrated at the end run when the agitator was shut off at [blacked out] in the tank).

Critical process parameters established during the original process validation for a [blacked out] batch in a [blacked out] hold tank for agitation speed used [blacked out] and for a [blacked out] batch in a [blacked out] hold tank used [blacked out] Original validation for the [blacked out] batch in a [blacked out] tank used weights from [blacked out]o weights of [blacked out] whereas the [blacked out] batch in a [blacked out] hold tank used weights from [blacked out] to [blacked out]

OBSERVATION 5

Written production and process control procedures are not followed in the execution of production and process control functions.

Specifically,

a. [Blacked out] requires a CAPA (Corrective Action Prevention Action) to be initiated when systemic GMP issues or significant trends have been identified associated with nonconformance events, consumer complaints, manufacturing events and significant trends. The procedure defines a CAPA as a process for ensuring that identified corrective and preventive actions are verified for effectiveness. No CAPA was initiated for the following batches from May 2009 – April 2010 where foreign material, particulate matter and/or contamination were observed:

-[Blacked out]
-[Blacked out]
-[Blacked out]
-[Blacked out]
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-[Blacked out]
-[Blacked out]
-[Blacked out]
-[Blacked out]
-[Blacked out]
-[Blacked out]
-[Blacked out]
-[Blacked out]
-[Blacked out]
-[Blacked out]
-[Blacked out]
-[Blacked out]
-[Blacked out]
-[Blacked out]
-[Blacked out]
-[Blacked out]
-[Blacked out]
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-[Blacked out]
-[Blacked out]
-[Blacked out]

b. No CAPA was initiated for 46 consumer complaints regarding foreign materials, black or dark specks from June 2009 to April 2010.

c. [Blacked out] section [blacked out] requires a [blacked out] metrics review of all new CAPAs, closed CAPAs, CAPAs open for more than [blacked out], and CAPAs exceeding the due date for review. No [blacked out] Metrics for CAPAs was completed.

d. No CAPA was completed for QN[blacked out] for OOS on [blacked out]

OBSERVATION 6

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

Specifically,

1. A thorough investigation or any additional analytical testing was not conducted for Infants Dye-Free Tylenol Suspension Drops, Cherry, 80 mg/0.8mL, Formula [blacked out] for the following:

a. [blacked out] lots that were super potent and confirmed to fail release specification of [blacked out] Acetaminophen (APAP) assay. For example(s) on End of Run Sample lot#s [blacked out] and [blacked out] [blacked out] is the [blacked out] batch manufactured of the [blacked out] batch campaign following manufacture of the demonstration batch, [blacked out] is the [blacked out] batch of the campaign, and [blacked out] is the [blacked out] batch manufactured. Quality Notification/Investigations [blacked out] rejected these [blacked out] batches based on release testing of end of run samples that failed assay.

b. The firm’s investigations did not extend to the [blacked out] other batches and the demonstration batch of the same drug product associated with the manufacturing change. These [blacked out] batches and demonstration batch passed release specs for APAP assay and were distributed to the market. For examples: lots [blacked out]

c. As of 04/23/10, no trending was completed to include the [blacked out] batches of the total [blacked out] batch campaign manufactured including: [blacked out]

2. The firm’s investigation into recalls for various Tylenol products containing [blacked out] did not include review of all lots of [blacked out] received from the contract manufacturer between the lot used in the manufacture of recalled products (i.e,[blacked out] to the first full lot of [blacked out] received from one entire vendor lot (i.e.,[blacked out] McNeil lot [blacked out] For examples: Vendor lots [blacked out………………. long black out ] Review of these [blacked out] vendor lots found that [blacked out] contained drums contaminated with gram negative organisms. Vendor lot [blacked out] was received on 12/04/08 as receiving lot [blacked out] and on 12/23/08 as receiving lot [blacked out] lots [blacked out] and [blacked out] were used to manufacture the following Tylenol Infant and Children’s products which were marketed/distributed and remain within expiration dating as follows:

a. Lot [blacked out] was manufactured into the following bulk/finished products lots:
– [blacked out] for Tylenol Infant’s Drops, 80mg/0.8mL, expiration date 11/10.
– [blacked out] for Children’s Tylenol Oral Suspension, expiration date 11/10.
– [blacked out] for Children’s Tylenol Oral Suspension, expiration date 11/10.
– [blacked out] for Children’s Tylenol Oral Suspension, expiration date 11/10.
– [blacked out] for Children’s Tylenol Plus Cold, expiration date 11/10
– [blacked out] for Children’s Tylenol Plus Multi-Symptom Cold, expiration date 11/10
– [blacked out] for Children’s Tylenol Plus Cold, expiration date 11/10
– [blacked out] for Children’s Tylenol Plus Multi-symptom Cold, expiration date 12/10
– [blacked out] for Children’s Tylenol Oral Suspension, expiration date 11/10
– [blacked out] for Children’s Tylenol Plus Multi-Symptom Cold, expiration date 11/10
– [blacked out] for Children’s Tylenol Oral Suspension, expiration date 12/10
– [blacked out] for Children’s Tylenol Plus Multi-Symptom Cold, expiration date 11/10
– [blacked out] for Children’s Tylenol Plus Cold & Cough, expiration date 12/10
– [blacked out] for Infant’s Tylenol Drops, expiration date 12/10
– [blacked out] for Children’s Tylenol Oral Suspension, expiration date 12/10
– [blacked out] for Infant’s Tylenol Drops, expiration date 12/10
– [blacked out] for Infant’s Tylenol Drops, expiration date 12/10
– [blacked out] for Children’s Tylenol Oral Suspension, expiration date 11/10

b. Lot [blacked out]
– [blacked out] for Children’s Tylenol Plus Cold & Cough, expiration date 12/10
– [blacked out] for Children’s Tylenol Oral Suspension, expiration date 12/10
– [blacked out] for Children’s Tylenol Oral Suspension, expiration date 12/10
– [blacked out] for Children’s Tylenol Plus Cold & Cough, expiration date 12/10
– [blacked out] for Children’s Tylenol Oral Suspension, expiration date 12/10
– [blacked out] for Children’s Tylenol Oral Suspension, expiration date 12/10
– [blacked out] for Children’s Tylenol Oral Suspension, expiration date 12/10
– [blacked out] for Tylenol Infant’s Drops, expiration date 12/10.
– [blacked out] for Children’s Tylenol Plus Cold & Cough, expiration date 12/10

OBSERVATION 7

GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

Specifically,

employees are not given training in current good manufacturing practices and written procedures required by current good manufacturing practice regulations as follows:

a. As of 04/23/10, [blacked out] Compliance Specialist, and [blacked out] Granulation Operator, did not attend new employee cGMP classroom training which is conducted [blacked out] [blacked out] version [blacked out] effective 3/29/10, [blacked out] requires initial cGMP training before department training.
– [blacked out] started working for the firm as a contract employee on 02/24/10, and started departmental training on 02/25/10.
– [blacked out] was temporarily transferred from the company’s Lancaster, PA plant from 02/01/10 to 04/18/10, and started departmental training on 02/01/10. According to [blacked out] version [blacked out] transfer employees must receive the same initial training as new employees.

b. As of 04/23/10, there was no documented training in [blacked out] for [blacked out] of [blacked out] granulation SOPs required to be reviewed by [blacked out] Granulation Operator, during his transfer from 02/01/10 to 04/18/10. The firm uses [blacked out] learning management system to electronically document training activities.

c. As of 04/20/10, [blacked out] Change Parts Coordinator, did not receive training on [blacked out] effective 04/02/10. [blacked out] is responsible for cleaning and maintaining tooling in the Compression tool room.

PRODUCTION SYSTEMS

OBSERVATION 8

Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.

Specifically,

No review of the batch production and packaging records was conducted for “lack of effect” regarding Infant’s Dye-Free Tylenol Suspension Drops, Cherry Lot [blacked out]

Quality Assurance evaluation of complaints documented in Quality Notifications (QNs) [blacked out] determined that no quality issues were warranted and hence, no manufacturing or packaging investigation was conducted. QN [blacked out] regarding the recall of Microcrystalline Cellulose and Carboxymethycellulose Sodium NF McNeil, lot# [blacked out] was associated with this finished product lot [blacked out] Approximately [blacked out] QN reports regarding lot [blacked out] were forwarded from the Corporate Benefits Risk Management group to this manufacturing site for investigation from August to November 2009.

OBSERVATION 9

Each container of component dispensed to manufacturing is not examined by a second person to assure that the weight or measure is correct as stated in the batch records.

Specifically,

Infant’s Tylenol Suspension Drops, Cherry, batch [blacked out]

Acetaminophen (APAP) Assay results for beginning, middle and end samples were OOS and sub potent as follows (release spec is [blacked out]
[blacked out] Beg = [blacked out]
[blacked out] Mid = [blacked out]
[blacked out] End = [blacked out]

Retest (i.e., re-measure) results were also OOS and confirmed the original OOS results.

Manufacturing batch records indicate that [blacked out] of the active APAP was weighed as required by the formulation. The batch record also states that the correct amount was weighted as [blacked out] drums at [blacked out] each) and [blacked out]drum of APAP at [blacked out]. The batch record indicates that the correct amount of APAP was weighted by operator 1 and verified by operator 2. Investigation states the likely cause of sub-potency is caused by not charging in the correct amount of APAP. A mix up occurred and a partial drum weighing less than the required amount was used instead of the correct drum. Operator 1 and Operator 2 weights checks did not prevent the use of the wrong amount of APAP.

LABELING & PACKAGING SYSTEMS.

OBSERVATION 10

Strict control is not exercised over labeling issued for use in drug product labeling operations.

Specifically,

on 04/20/10, labeling was observed to be stored throughout the warehouse accessible to all warehouse operators and personnel that have access to the raw material/component storage warehouse. Labeling was not stored in a locked cage with limited access. For examples:

a. [blacked out] immediate container labels for Concentrated Motrin Infants’ Drops, Oral Suspension, 50 mg ibuprofen per 1.25 mL, 1 fl.oz., Original Berry Flavor, part [blacked out] label lot [blacked out] were stored in warehouse location [blacked out]

b. [blacked out] immediate container labels for Children’s Tylenol Plus Multi-Symptom Cold, Oral Suspension, 160 mg acetaminophen per 5 mL, 4 fl. oz., Grape, part [blacked out] label lot [blacked out] were stored in warehouse location [blacked out]

c. Several others.

LABORATORY OPERATIONS

OBSERVATION 11

There is no written testing program designed to assess the stability characteristics of drug products.

Specifically,

a. Lack of stability data to support the [blacked out] expiration date assigned to lots produced following the manufacturing change for Infants Dye-Free Suspension Drops, Cherry, 80 mg/0.8 mL, Formula[blacked out] using a [blacked out] batch size in a [blacked out] hold tank. For examples, [blacked out] released/marketed batches: [blacked out] (demonstration batch), [blacked out …..long black out]

b. Stability samples collected off of the packaging line for lots [blacked out] were pulled from the beginning of the packaging run only. Per [blacked out] for [blacked out] all stability samples are pulled from the beginning of the packaging run. Stability samples are not representative samples from the beginning, middle, and end of the fill run specifically for the three batches with super potent end sample fills. For example, [blacked out]

OBSERVATION 12

Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.

Specifically,

Scientific justification does not identify the reason(s) why the firm does not test TSA, a non-selective general microbial growth medium, lot [blacked out]uring growth promotion tests for microorganisms to include for example, molds, yeasts, and other potential known environmental contaminants found in the manufacturing facility and/or raw materials. This media was used for testing raw materials and finished products for microbial limits testing from 03/01/09 to 08/03/09. [blacked out] was isolated from raw material lot [blacked out] (vendor lot [blacked out] however, TSA was challenged with [blacked out] and [blacked out] only. [blacked out] was isolated from raw material lot #s [blacked out] (vendor lot [blacked out]

OBSERVATION 13

Adequate lab facilities for testing and approval or rejection of components and drug products are not available to the quality control unit.

Specifically,

1. Lack of investigation, review and follow-up of [blacked out] as follows:

a. Calibration on 03/09/10 per Test Report No[blacked out] demonstrates that certification of the [blacked out] was outside the [blacked out] tolerance criteria and the leak test for the [blacked out] filter failed the specification of penetration [blacked out] of the upstream concentration in two areas on the [blacked out] filter at [blacked out] in addition to leakage at the frame.

b. Test report No. [blacked out]demonstrates airflow into the [blacked out] back room where microbiological testing of finished products and raw materials is conducted in Hoods [blacked out] in relation to the general microbiological room outside of the [blacked out] airflow is not positive to the general microbiological room (i.e., Walk-In Chambers, refrigerator and freezer room).

c. The aerosol challenge installation leak test and air velocity results per Test Report No. [blacked out] was not evaluated by the microbiological laboratory until requested during the current inspection. This report is typically sent from the contract service to the maintenance department and filed with no evaluation or follow-up by the microbiological laboratory personnel concerning failing results.

d. No procedures regarding the allowable percentage of leakage across the [blacked out]ilter and no specifications concerning the width and height areas for total allowable repairs.

2. Lack of investigation, review and follow-up of [blacked out] as follows:

a. Calibration on 03/09/10 per Test Report No. [blacked out] demonstrates that certification of the [blacked out] velocity was outside the [blacked out] tolerance criteria and the leak test for the [blacked out] filter failed the specification of penetration [blacked out] of the upstream concentration in two areas on the [blacked out] filter at [blacked out] in addition to leakage at the frame.

b. Calibration on 09/16/09 per Test Report No. [blacked out]demonstrates that certification of the [blacked out] air velocity was outside the [blacked out]olerance criteria.

c. The aerosol challenge installation leak test and air velocity results per Test Report No. [blacked out] was not evaluated by the microbiological laboratory. This report is typically sent from the contract service to the maintenance department and filed with no evaluation or follow-up on failing results.

d. No procedure regarding the allowable percentage of leakage across the [blacked out] filter and no specifications concerning the width and height areas for total allowable repairs.

3. On 04/19/10, during the walk through of the Microbiological Laboratory, the following deviations were observed:

a. No cleaning/use log for the [blacked out] used for raw material weighing.

b. Thick dust covering the grill inside the [blacked out] filtered cabinet.

c. No identification of the temperature probes in [blacked out]

d. Duct Tape wrapping the copper piping insulation inside the [blacked out] where the firm stores water samples and refrigerated media.

e. Incubator [blacked out] had a large amount of visible grey and brown dust/debri observed on the bottom of the chamber under the shelves where media filled containers and media hold time studies were located.

f. There was a large exposed hole (gap) in the ceiling above incubator [blacked out] and next to the air vent in the ceiling.

g. No inventory of [blacked out] containing [blacked out] organisms.

h. Various microbiological rooms containing laboratory equipment “not in-use” that contained dust/debri. “Out of Service” equipment cluttered laboratory areas. For examples, equipment “out of service” dates are as follows”
– water sample refrigerator [blacked out] (dated 07/2007);
– pH meter (09/30/09);
– Shaker incubator (12/16/08);
– Culture incubator (May 2007); Etc.

4. On 04/22/10, the following deviations were observed during microbiological testing of Children’s Zyrtec Sugar Free Syrup, lot [blacked out] formula [blacked out] in the [blacked out] Back Testing Room in Hood [blacked out]

a. Hood [blacked out] had about a 6 inch silicon plug located on the right side upper [blacked out] filter.

b. The left side of the [blacked out] had a very large spider-like crack on the left side of the hood plexiglass where the gas vacuum hose was located. This vacuum hose is not used.

c. The microbiologist was observed to pour media into the negative control (i.e., small bottle) placed in front of the larger 250 mL bottle, which blocked/disrupted the [blacked out] air flow.

d. The microbiologist was observed to open media (i.e. [blacked out]) close to outside of the hood rather than inside the hood with [blacked out] filtered horizontal airflow.

e. The microbiologist was observed to spray hands and items in the hood with [blacked out] Disinfectant Scented Spray directed into the [blacked out] filter.

f. The microbiologist was observed to spray the outside wrapped items placed in the hood, which were opened outside of the hood rather than inside the hood. For example, pipettes used to transfer product with [blacked out] to the plates.

g. Grills in front of the entire face of the [blacked out] filters in Hood #s [blacked out] were plastic with one inch diameter squares and not easily sanitized/cleaned. Hood [blacked out] grill was dirty with grime in each square and missed pieces of plastic in several locations on the plastic grill.

OBSERVATION 14

Laboratory records do not include complete records of the periodic calibration of laboratory instruments, gauges, and recording devices.

Specifically,

Laboratory refrigerators (i.e., [blacked out] were not calibrated adequately in that they were not calibrated to the probes inside the units or to a national standard until 04/22/10.

OBSERVATION 15

Written specifications for laboratory controls do not include a description of the sampling procedures used.

SOP deficiencies:

a. [blacked out] for [blacked out] does not include the dilution to use under Section [blacked out] for Results/Levels. The number of colonies observed is not to exceed more than [blacked out] merely references section [blacked out] for [blacked out] regarding microbiological swabbing.

b. [blacked out] does not identify the microbiological swab used for swabbing equipment after cleaning for Bioburden samples. The micro swab used is [blacked out] Applicators (Cotton), Catalog[blacked out] This SOP identifies the [blacked out] which is used for analytical cleaning procedures (e.g. [blacked out —–long black out]

MATERIAL SYSTEM

OBSERVATION 16

Samples taken of in-process materials for determination of conformance to specifications are not representative.

Specifically,

Raw material (tail gait) samples pulled by the manufacturer at the request of the firm for [blacked out] is not a statistically significant (i.e.,[blacked out]= the number of containers) representative sample of the total [blacked out] per pallet). The sample includes only [blacked out] bag from each of [blacked out] pallets or [blacked out] samples.

OBSERVATION 17

Each lot of components was not appropriately identified as to its status in terms of being quarantined, approved or rejected.

Specifically,

Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of released components and labeling. 211.42 (c) (3)

a. On 4/20/10, drug components and labeling in unrestricted status were observed stored in the open incoming inspection area in the warehouse, along with materials in quarantined and blocked status. Materials were stored in two lanes of pallets on the floor, and included:
– [blacked out] immediate container labels for Children’s Non-Drowsy Reactine, Cetirizine Hydrochloride Syrup, 5mg/5mL, 118 mL, Dye Free Grape, part [blacked out] label lot [blacked out] unrestricted in [blacked out]
– [blacked out] of Artificial Bubblegum Flavor, part [blacked out] component lot [blacked out] quarantined in [blacked out] but lacking a status sticker.
– [blacked out] of Corn Starch NF, part [blacked out], component lot [blacked out], blocked in [blacked out] bearing a status sticker, leaking powder from one bag

The status of the materials could not be determined via visual examination, with the exception of the Corn Starch NF.

b. On 04/20/10, [blacked out] cartons for Concentrated Tylenol Infants’ Drops, 80 mg acetaminophen per .8 mL, 1 fl. oz., Dye Free Cherry, part [blacked out] label lot [blacked out], were observed stored in cardboard boxes on a pallet in the incoming inspection area. “Bad cartons” had been handwritten in black ink on the card board boxes. The cartons were in unrestricted status in SAP.

c. Stock Room [blacked out] Restricted Storage Room located in the microbiological laboratory had excess media in boxes and special projects stored in the room with no designated areas of storage for approved, quarantine, or rejected status. The room was cluttered with boxes of media, special projects that had bins with various containers of chemicals, special projects with boxed finished OTC products, boxes of computer items, out of service equipment, etc. Until 04/23/10, the firm had no inventory of the room contents.

OBSERVATION 18

Components are not microscopically examined when appropriate.

Specifically,

There are no monthly trend reports written for the microbial water test results per [blacked out] for [blacked out] since on or before 05/01/09. Pages 18 and 19 of 25 reads in part: “9.0 DOCUMENTATION 9.1 The monthly/weekly samples are automatically logged into the computerized data system [blacked out] ***9.2 Results are documented in the assigned laboratory logbook and are entered into the computerized data system [blacked out] ***9.3 A monthly report of microbial water testing results shall be performed and documented. 9.3.1 The monthly trending of the purified and potable water systems is done *** throughout the facility. ***9.3.2 The report will consist of the current month and at least the summarized data from the previous month. 9.3.3 The following must be part of the full report: *** Sanitization dates of the system *** Quantity of samples *** Quantity of samples within limits *** Action/Alert levels *** Investigations *** 9.3.4 The report will be initiated by a Team Leader or designee and will be signed by the Microbiology Manager *** The Team Leader will have the responsibility of collecting and compiling the information from [blacked out] or the testing logbooks and verify its accuracy. The Microbiological Manager will review the report for completion and determination of any abnormal trends of the water system. ***9.3.5 The report will be completed within sixty days from the end of the month. ***”. No [blacked out] data was entered from 02/09/10 to 04/24/10. No trend reports of microbial water testing results was conducted and documented since on or after 05/01/09.

FACILITIES & EQUIPMENT

OBSERVATION 19

Records are not kept for the maintenance and inspection of equipment.

Specifically,

a. On 04/20/10, hoses on the [blacked out] were said to not be dedicated to products processed on these two fluid bed dryers by an operator and team leader. Cleaning validation of the equipment did not evaluate cleaning of the 2.5 foot hose on [blacked out]ecause the cleaning validation followed [blacked out] Cleaning of equipment lacks documentation that [blacked out] was followed and/or a statement that the 2.5 foot hose was removed and replaced after the campaign was completed for each drug product processed in the [blacked out] For example, cleaning on 04/17/10 by operator [blacked out] and verified by operator TE. In addition, the person verifying that cleaning was performed [blacked out] on 04/17/10 was a temporary person from a different McNeil site and lacked training on [blacked out]

b. Seals on the [blacked out] were observed to be in disrepair and not maintained with several cracks.

c. Inlet air insulation was wrapped with peeling masking-like tape.

d. No documentation on cleaning and maintenance of the Microbiological Laboratory [blacked out]ondenser filter and gasket as required. On 04/19/10, the [blacked out] was observed to contain a large amount of visible grey and brown material on the filter behind the grill. Review of the manufactures’ maintenance manual indicates to clean the condenser at least every [blacked out] or more often if the laboratory area is dust prone. The filter should be removed, fan checks performed, filters replaced, and condenser vacuumed.

OBSERVATION 20

The persons double-checking the cleaning and maintenance are not dating and signing or initialing the equipment cleaning and use log.

Specifically,

No second signature verifying that maintenance was completed. The second signature in the system is a sign off that the maintenance was entered into the system and not verification of the adequacy of maintenance conducted. For examples, Maintenance [blacked out]ated 12/11/09; Maintenance [blacked out]417/10; etc.

Anita R Michael, Investigator
Matthew R. Noonan, Investigator
Sharon K. Thoma, Investigator
Hala L. Selby, Investigator

Date Issued – 04/30/2010

Click on the link below to view the original report.

Food & Drug Administration Facility Inspection Results for McNeil Consumer Healthcare, Division of McNeil-PPC, Inc.

McNeil facility inspection report

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