Archive for the ‘Pharmaceutical Excipients’ Category

“Instead of deliberately favoring democratic industrialists, we have spent most of our billions in backing predatory institutions which, based on their history and present activities, will probably align themselves against us in the showdown between East and West—and this policy alone could easily  make the difference between defeat and victory for democracy. Would that we had such desperate faith in democratic institutions that we could afford the gamble of similar billions for their survival! For every dollar we have spent in Europe to strengthen democracy and arm it against conquest, we have thrown several dollars within reach of the enemy.

In the Far East, as well as Europe, the United States has backed other totalitarian-minded groups as a “bulwark” against communism. By the end of World War II, the peoples of China, Korea, Indo-China, and the Philippines had suffered for years under the “New Order for Asia” sponsored by the Japanese equivalent of Farben, the Zaibatsu cartels. These cartels by force of arms won a stranglehold on the economies of these countries. Instead of rebuilding the Far East generally as fast as we could, we have peddled the fear that Russia would rob and plunder the people, while at the same time we backed the very forces which had already robbed and plundered them. The Zaibatsu cartels are as strong as ever. In Indo-China, we have backed the collaborators of the “Japanese New Order.” In South Korea, faced with a variety of truly democratic choices, we backed Syngman Rhee and the few landowners and cotton millers who cast their lot with the “New Order” gang.

The Voice of America must sound weak to those forced by the United States to choose between Communism and reliving the dark era of World War II. Their will to resist Communism is weakened—to put it mildly—by our facing them with this black alternative.

Can we expect millions of former vassals in Asia to rally around their erstwhile totalitarian oppressors? Can we rally Europe solely around the fear of Soviet enslavement while we deliberately sustain the forces which twice in recent history have enslaved that continent?

On the answer to these questions depends on our survival.” – Page 363

“To the inmates of Camp I, the word “Buna” (which included “Leuna”) was more frightful than “Auschwitz” — the Farben site more terrifying than any place except a large wooded area three kilometers east of Camp I. During the first weeks of construction the workers at Camp I were routed out of bed every morning, stood roll call, ate a poor breakfast, and were marched by the SS five kilometers to the plant. Until this day of testimony, Ambros had insisted several times that disciplinary actions on the site were the responsibility of the SS. Now for some strange reason, he admitted: “I do know for sure that already in 1941 one began to fence off squares, blocks, and in these squares no SS had any further business. That was the preliminary stage for having the entire plant fenced in.” The workers had confirmed this. Once inside the plant enclosure, they found that the Farben overseers outnumbered the SS by 10 to 1…. “We struggled to carry cables, collapsing under the strain; the work was too heavy even for a nourished man.” “Once the inmates were assigned to Farben Meister, they became his slaves.” The prisoners of war, who were given easier jobs, remembered better and longer than most. “The inmates were forced to carry one-hundred C-weight bags of cement. It took four men to lift one bag and put it on the back of one man. When inmates couldn’t go along quickly enough to satisfy the Farben Meister, the Meister beat them with sticks and iron bars and punched them with his fists and kicked them. I have often seen them beaten to death with iron bars.” “When inmates first arrived at the I.G. Farben factory,” one of Ambrus’ underlings had testified, “They looked reasonably well. In two or three months, they were hardly recognizable as the same people; the worst thing was the lack of food… I am not a scientist, Mr. Counselor, I would not pose as an expert on calories or grams or liters. I can merely say what I saw…. And my Czech physician friend was an expert. The Czech physician said: “The prisoners were condemned to burn up their own body weight by working.” Before construction was finished, nine out of ten punishments were meted out by the Farben plant employees. The SS at Camp I became concerned with the depletion of the labor supply. The most ironical occurrences were the repeated complaints of an SS man to his superior that a Farben foreman was beating the prisoners too often — it happened at the plant as it happened at the mine. “I did not observe anything of that kind,” Ambros said – Portions from pages 178 – 181

The buna factory they wanted to build would have a capacity larger than any of the others. They would need a million tons of hard coal, and Oswiecem was on the southern border of the Silisian coal fields. The plant needed as much power as the city of Berlin, and here at Oswiecem three rivers united—the Sola, the Przemsze, and the Little Vistula. East of the town was another river which could furnish extra power and would take off the waste from plant.

A buna factory needed a lot of water, even in winter. They planned to cut a canal to connect the Vistula to the Oder a few miles away. Oswiecem was on a level plain, and all the waters of all the rivers around could be harnessed without flooding. Oswiecem fell on a line between Krakow and Vienna, and the old short stretches of railways could be joined to ship the buna back to the Reich. Said Ter Meer: “There were really so many of our industrial prerequisites that one has to admit that this location, Auschwitz, was ideal industrially.”

Ter Meer and Ambros looked over the people. “Nature had endowed this place, “Ambros said. “There were men and women [in the whole territory] working partly in industry and also doing part-time farming work. Sociologically, the most ideal condition is to find workers who also have a small plot of ground. This meant everything a chemist could dream of.”

The impressions gleaned by the two doctors were almost Biblical. They were rapt in contemplation of a business which would offer a pastoral craft to the rural inhabitants. Early in the morning, the farmer would get up and milk his cows, then stroll off—lunchbox in hand—to the plant. He would work there in the afternoon while his wife and daughter toiled in the vineyard. Everything about the picture was charming—except that there were not 15,000 such farmers near-by.

But Ter Meer didn’t believe that Ambros, in inviting him there, had mentioned a concentration camp. ”I do not recall that he at the time discussed that some of the labor would be drawn from the near-by concentration camp, but I will say that Ambros, who in his reports was very exact, probably mentioned it, though I am not positive.”

Ambros was very exact.  A few weeks later, he reported twice to a group of buna colleagues at Ludwigshafen that plans were being made to build a second concentration camp at Auschwitz: “The inhabitants of the town of Auschwitz itself are 2000 Germans, 4000 Jews, 7000 Poles. The availability of inmates of the camp would be advantageous.”

Three thousand people were in Camp I. Then the second camp swelled the prison population to 14,000—Dr. Ter Meer was never to share his lunch with them. During the first two years of construction, reports came to his office of daily trainloads of “workers” coming to Auschwitz. Then Camp III and Camp IV were built, both nearer the buna factory than the other two camps. Then at last, in 1943, Ter Meer made a third visit to Auschwitz. Returning to Frankfurt, he had himself transferred to Italy, where he became plenipotentiary for the Italian chemical industries. Ambros’ appeals followed him: “More workers are needed.” “Herr Doctor Ambros is asking for assistance at Auschwitz.”….

Q. We have heard from four other witnesses that there was supposed to have been a large chimney in this camp, too. Do you have any recollection of it?

A. I have no recollection of it.

pages 155 – 156

Ambros bowed as he took oath, exhibiting his sketch in all directions. He waved his counsel aside for the moment. He explained: “This tree of many branches I choose to call the Ethylene Tree to symbolize the Good and Evil in nature.”
Ethylene oxide, he went on, was the trunk which bore many branches “green with peaceful uses” and a few that were rotten with potential destruction. He pointed to lines he had drawn to cut off the rotten branches. Green branches had been his sole interest: soap for dirty soldiers, paint and cleaning agents for vehicles. “I still do not understand why I am here. The collapse promised everything but that I would be arrested.”
At Gerdorf, after those senseless investigations, the Americans had been kind enough to lend him a jeep and driver, to take him back home. Surely, if he had deserved arrest, the French at Ludwigshafen would have picked him up. He’d lived in Ludwigshafen since the mid-1920’s; people there thought he was just born for the place. If Heidelberg was the seat of chemical knowledge, Ludwigshafen was nature’s laboratory; and Ambros was the sort of man who liked earth running through his fingers. At Ludwigshafen, more productive than any other single Farben installation, were planted the synthetic seeds of every Farben product. Ludwigshafen put out the elementary compounds that became hormones and vitamins under Hoerlein at Elberfeld. At Ludwigshafen, the organic roots under careful cultivation grew their first ersatz offshoots. His “mother” was Ludwigshafen, said Ambros; but he owed a good deal, too, to his real father, a professor of agricultural chemistry, who had taken him into the laboratory before he could toddle. It was understandable that, at first sight of Oswiecem, he noted it was “predominantly agricultural terrain.”
When Bosch and Krauch hired Ambros, they got a young man with brains as well as feet in the soil. Bosch, recognizing a young excitable genius, turned him loose to study natural dyes and rosins and yeast breeding and sugar fermentation. Soon the Ethylene Tree was bearing synthetic twigs based on his studies.  – page 170

“Sure, we must have a theory. It’s just like what the first caveman said when he caught his neighbor dragging his wife away: ‘Would you please wait a minute while I get hold of a lawyer?’ When a hungry man steals a chicken, that’s larceny if the statute says it’s larceny. But stealing whole territories is not larceny — that’s foreign policy.”

The car almost went off the road as I listened to him expound. “Murder is a crime in every country in the world, but it’s no crime in the world-at-large because the Second Circuit Court of Appeals never said so. Ask Senator Taft. He never took the trouble to call it murder before anyway, so now he says: ‘How can you call it murder after the war is over? The charges are very badly drafted, Joe. We should have charged excusable larceny and justified, premeditated killing. That’s the kind of theory they’ll be happy with.”
“That’s hardly fair,” I said. “If judges felt that way, they wouldn’t be sitting on this trial.”
If only a “theory” were as simple as he had put it! The bitter edge of his tone suggested the simple injustices that “civilized countries,” one by one, had tried to remedy, but against which the world-at-large had done almost nothing. Yes, there was a lot of truth in Minskoff that couldn’t be squeezed into a usable idea for next Monday morning — or could it?….

“A surprise is coming up,” Minskoff said. “Get ready for a sharp right.”

Around the turn, behind a high barbed-wire fence, deep-green grass leveled out for more than a mile ahead. Set back a good distance from the road was a group of buildings covering an area of about three city blocks. Midway between the road and the building was a large sign: “Prager Verein.”
“We should have stopped in Pilsen,” Minskoff said. “In Pilsen, they still call this place ‘Farben.’ When Farben took over here, they impressed about 1100 people from Pilsen. Six hundred of them ended up at Auschwitz. Of course we’re in Bohemia now, but this is the parent factory of the first two chemical outfits Farben grabbed in Sudetenland—isn’t that right?”
I agreed. This is not being a part of his job, he must have learned the fact somewhere around here.
“Farben got to Czechoslovakia before Hitler did, didn’t they?”
I nodded as the car slowed down. Stopping, we got out and went up the main gate. The guard listened to our explanation, smiled, and asked rhetorically, “Americans?” and let us through. I thought of Paul Haefliger again, and of how Farben was always months ahead of the Nazis. Somehow that should mean more than it did. The Farben doings in Czechoslovakia were linked to the Farben doings in Austria the previous year by purpose and method, but from the legal standpoint they seemed to stack up as separate ventures. According to the Munich Pact the territories of Bohemia and Moravia were supposed to remain Czech. Therefore, technically Prager Verein was still “free” when Farben took over its two subsidiaries, in the Sudetenland. Regarding the taking over of the subsidiaries, I recalled a couple of sentences from the Farben report: “One 1st October began the marching in of the German troops. On 3rd October, Falkenau factory was occupied.” But Farben had been “negotiating” in Sudetenland a long time before that….

We might have been stopping at any one of three or four factories on Route 25 between Newark and Camden, New Jersey — except for that institution of evil. Farben had been months ahead of Hitlerin organization financial power and in the conquest of productive installations. The Munich Pact had been signed in September 1938. But even before Munich — and several months before the Nazi troops had marched here in Bohemia — Farben had been negotiating to try and take over this parent company. Also before Munich, another firm had arrived in Prague to compete with Farben. Von Schnitzler had sold a piece of Prager Verein to this competitor before he even had any part of it to sell. (Farben was to get this piece back after gaining a majority control.)
In Von Schnitzler’s own words, seldom had a “great international agreement been concluded so quickly.” At a conference in November 1938, in Berlin, to which the Prager Verein managers were “invited,” Schmitz and Ilgner had come to form an impressive audience to Von Schnitzler’s demands.
The pressure had culminated in a December meeting, Von Schnitzler presiding. The occupation of Prague was still four months away. Von Schnitzler used the Sudetenland occupation as the persuader. He told Prager Verein representatives that he knew they were trying to “sabotage” the deal and that he was going to report to the German government that Prager Verein’s resistance was menacing social peace in the Sudeten area. Unrest could be expected at any moment, he said, and Prager Verein would be responsible. Actually, there were not many Jews in Prager Verein, and Hitler had no plans at all for taking it over.
Missoff chuckled over Von Schnitzler’s commercial generalship. Farben had not only swallowed the lignite mines and dyestuffs of Prager Verein, but all intermediate plants, stocks, good will, patents, and trademarks. Altogether it was no small feat to do in a couple of months the paperwork that turned the fourth largest business on the Continent into a Farben subsidiary. Minskoff was chuckling even after we hit the road again. He quoted Cardozo’s dictum: “Every man has a little larceny in his heart.”

– Portions taken from pages 104 – 106







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Trade Secrets Documentary by Bill Moyers



Trade Secrets – Transcripts



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


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?


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.


NARRATION: And this is the result of that vow.

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


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.


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.


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?


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.


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.


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… ”


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.


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.


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.


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.”


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.”


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.


“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.


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.


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.


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 –


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.


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.


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…?


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?


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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The Lake Effect by Nancy Nichols

By the time the PCB problem was isolated in January 1976, the Illinois Environmental Protection Agency believed that Outboard Marine was delivering approximately nine to ten tons of PCBs to the harbor each day. The PCB content of the sludge at the bottom of the harbor ranged from 240,000 to 500,000 parts per million depending on when and where the sample was taken. That means that either one in two or one in four grains of sand or silt at the bottom of the harbor was not actually sand or silt, but was a PCB instead. page 43

Waukegan would take its turn on the national stage two years later, in 1984,when a U.S. Environmental Protection official, Rita Lavelle, was accused of secretly meeting with lakefront polluters in an effort to strike a cleanup deal that heavily favored industry… In the aftermath of the scandal, the full extent of Waukegan’s chemical contamination was revealed… Eventually, three separate Superfund sites, named after the 1980 federal legislation that allocated funds to clean them up, were designated in Waukegan. Two of the sites are adjacent to the lake… In addition, more than a dozen other sites form what federal and state regulators call an expanded study area, which stretches along the lakefront from one end of town to the other. These smaller sites contain the waste products from a tannery, a steel company, a paint factory, a pharmaceutical company, and a scrap yard. Together these sites contain not just PCBs, but an alphabet soup of pollutants. “Just about every chemical we know to be dangerous to human health is in one of those sites,” Says Margaret Quinn, a professor at the University of Massachusetts, Lowell, who specializes in human exposure assessment. In addition to PCBs, these chemicals include benzene and other volatile organic compounds, arsenic. lead, asbestos, polycyclic aromatic hydrocarbons (PAHs), dioxins, vinyl chloride, and ammonia. Various chemicals among these have been associated with reproductive diseases, learning and attention deficits in children, birth defects, immune system deficiencies, and some forms of cancer.

Was there a relationship between my sister’s cancer and the toxins of our childhood? My sister certainly thought so. And many other people have suspected, often correctly, that elements in their environment have had an effect on their health. Yet because of the long time it takes for a cancer to develop and because of relative mobility of our lives today, it can be challenging to establish a casual link between a disease and its origin.

pages 5 -6

“Ovaries are approximately three centimeters long by one and one-half centimeters wide by one centimeter thick,” writes Ethel Sloan in, “The Biology of Women.”… Whichever edition you consult will tell you that the ovary is about the size of an almond and that it produces the female hormone estrogen. During the monthly menstrual cycle, each ovary forces an egg through a wall of tissue and afterward repairs that rupture in a process called ovulation. “The ovary is no beauty,” writes Natalie Angier in “Woman: An Intimate Geography, “It is scarred and pitted, for each cycle of ovulation leaves behind a blemish where an egg follicle has been emptied of its contents. The older the woman, the more scarred her ovaries will be. It is this continual bursting and repairing–part and parcel of the ovarian life cycle–that makes the ovary vulnerable to cancer.

Scientists have long theorized that as cells multiply each month to repair the breach in the ovarian wall, more opportunities are created for mistakes in the DNA copying process, which in turn increases the chances of a malignant mutation. More ovulations, in other words, mean more chances for mistakes.

Risk factors for the disease therefore include never giving your ovaries a break by being pregnant or having a child. The other risk factor is having a close relative with the disease. That would be my sister, of course, and that would bring our story back home….

Doctors at this hospital and elsewhere have long speculated that there were significant environmental factors associated with ovarian cancer. The vagina provides a runway to the ovaries not simply for sperm but for many other substances as well. Significantly, women who have their tubes tied experience a lower rate of ovarian cancer than those who do not. Some have theorized that this may be because the pathways to the ovaries has been blocked, keeping outside agents at bay.

For example, some researchers have found a link between talcum powder and ovarian cancer–though several other studies have produced conflicting results. Some early forms of talcum may have contained asbestos and thus given researchers their positive findings. Indeed, at least one retrospective study found a much higher disease rate among women who used talc prior to 1960 than those who used is after–giving at least some credence to the idea that the use of asbestos-laden talc increases a woman’s risk of ovarian cancer.

My sister speculated that asbestos had contributed to her illness. A group of naturally occurring fibrous materials that are fire-resistant, asbestos has been thought to cause adverse health effects since the first century. Yet, as writer Paul Brodeur tells us in his book on asbestos, Outrageous Misconduct, its role in causing the disease asbestosis, a noncancerous condition in which the lungs scar so badly that they won’t expand and contract properly, was not well established in medical literature until the 1970s.

In the years before my sister died, when I was an editor for the Harvard Business Review, I worked on a piece written by Bill Sells, the man who had run the Johns-Manville plants in Waukegan in the early 1970s–a time when deaths from asbestosis and other asbestos-related diseases were beginning to occur in the workforce at an alarming rate. After noting that his job included the unenviable task of visiting his sick and dying employees at the local hospital, he offered this description of his first visit to the factory: “The plant lay at the back of a sprawling complex built in the 1920s. Its view of Lake Michigan was obscured by a landfill several stories high. A road wound through this mountain of asbestos-laden scrap, and as I drove through it for the first time I stopped to watch a bulldozer crush a 36-inch sewer pipe. A cloud of dust swirled around my car.” Inside the plant, he said, he found “asbestos-laden dust coating almost every visible surface.”

An EPA official charged with overseeing the cleanup of the Johns-Manville plant, Brad Bradley, has a similar recollection. Standing at the edge of the 350-acre Superfund site that overlooks Lake Michigan, Bradley recalled his first visit there in 1982. He remembers asking an asbestos expert where he thought they would find the fibers. “I think they are everywhere,” said the expert. Indeed, virtually anywhere on the site that Bradley scuffed the ground with his boot, he found the telltale fibers.

People are more likely to connect the fiber with asbestosis than with ovarian cancer. However, a thirty-year study of nearly two thousand women who worked with asbestos while manufacturing gas masks during World War II showed these women to be seven times more likely to die from ovarian cancer than a control group. My sister’s medical history seems to tell a different story, though, and the link between asbestos and ovarian cancer in general does not appear to be a strong one. The ovarian cancer specialist I saw at the clinic was quick to point out that my sister’s record indicated that her cancer was preceded by endometriosis.

The phrase “painful periods” does not begin to describe the torture that my mother and sister endured during menstruation. White and sweating, doubled over with pain, they retreated to the bed or the couch until the pain and the bleeding passed. When I recounted my mother’s experience, the ovarian cancer specialist suggests that my mother also likely suffered from endometriosis.

Endometriosis is a once rare disease that is now common. When the disease was first named and discovered in 1921 by a New York physician, there were only twenty reports of the illness in the medical literature. Today, the National Institutes of Health estimates that roughly 5.5 million women suffer from the disease in the United States, and as many as 89 million women may have it worldwide. An exact number is hard to come by, since the disease can only properly be diagnosed during surgery. Still, about one-third of women of childbearing age suffer some symptoms–including pelvic pain and infertility–and in the United States at least, the average age of onset has been declining…

Endometriosis is a complex condition, and no one is certain what causes it. Some scientists believe it is an immune system disorder. Others believe that women with endometriosis lack the ability to shed cells that have migrated and are growing where they should not be. Other scientists have focused on a genetic component of the disease since it can run in families. A woman with a sister or mother with endometriosis, for example, is three to seven times more likely to get the disease.

The mechanisms of endometriosis are not that different from those that create cancer: they involve cell proliferation, the migration of cells, and a change in their cellular nature. Endometriosis grows unchecked and invades surrounding tissues, and the body’s immune system fails to rid itself of the misplaced lesions. In the same way, the body fails to rid itself of cancerous lesions.

It is often but not always the case that the kind of cancer my sister suffered from, ovarian clear-cell adenocarcinoma, is preceded by endometriosis, and many believe that there is a relationship between the two diseases. Some scientists believe that endometriosis–in certain cases–is a kind of precancerous condition, and others believe that the two diseases spring forth in unison. Other experts theorize that the endometrial cells themselves drive the proliferation of cancer once it has started by producing their own estrogen. Each lesion is capable of increasing the local production of estrogen, so that once the disease takes hold it is capable of feeding itself.

In my sister’s case, cancerous growths arose within her endometrial lesions. Whatever the exact mechanism of disease development, women with the type of ovarian cancer that my sister suffered from have higher rates of endometriosis that the general female population. In one study, about 70 percent of the women with clear-cell ovarian cancer also had endometriosis.

Scientists have long suspected that chemicals of the type found in Waukegan–dioxins, PCBs, and polycyclic aromatic hydrocarbons (PAHs)–play a role in human endometriosis.

pages 75 – 81

Carson died in 1964, but her work and her life serve as a warning to everyone who struggles with cancer. “As we pour millions into research and invest all our hopes in vast programs to find cures for established cases of cancer,” she wrote, “we are neglecting the golden opportunity to prevent, even while we seek to cure.”

Carson’s favorite quote, from Abraham Lincoln, can be found snuggled into her almost daily letters to Freeman, where she explains what keeps her going through her treatments and on to finish her groundbreaking book. It reads: “To sin by silence when they should protest, makes cowards of men.”

page 122

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The following review by the American Academy of Pediatrics is critical to understanding the risks taken when our children are prescribed medications. If your child falls into the percentage of children that have adverse reactions to prescription medication excipients, it could cost your child’s life or cause significant unnecessary suffering. The following review examines 187 studies of adverse reactions to pharmaceutical excipients (An “excipient” or “inert” is considered an “inactive” ingredient in pharmaceutical formulations). These ingredients are no longer just water or table sugar. In some children, these ingredients cause death. Despite the repeated lobbying by the American Academy of Pediatrics to make mandatory labeling of all “inactive” or “excipents” in children’s pharmaceuticals, the FDA has sided with the pharmaceutical industry. The labeling of excipients continues to remain voluntary. It begs to ask the question, “If all ingredients are not labeled due to “trade secret” laws then how can they FDA ensure its safety?” The following report fully illustrates the negative impacts on our children’s health due to this reckless policy. I have pasted the document but you may also access it through the link.

PEDIATRICS Vol. 99 No. 2 February 1997, pp. 268-278

“Inactive” Ingredients in Pharmaceutical Products: Update (Subject Review)

Committee on Drugs


Because of an increasing number of reports of adverse reactions associated with pharmaceutical excipients, in 1985 the Committee on Drugs issued a position statement1 recommending that the Food and Drug Administration mandate labeling of over-the-counter and prescription formulations to include a qualitative list of inactive ingredients. However, labeling of inactive ingredients remains voluntary. Adverse reactions continue to be reported, although some are no longer considered clinically significant, and other new reactions have emerged. The original statement, therefore, has been updated and its information expanded.

Full Report


Pharmaceutical products often contain agents that have a variety of purposes, including improvement of the appearance, bioavailability, stability, and palatability of the product. Excipients (substances added to confer a suitable consistency or form to a drug, such as the vehicle, preservatives, or stabilizers) frequently make up the majority of the mass or volume of oral and parenteral drug products. These pharmaceutical adjuvants are usually considered to be inert and do not add to or affect the intended action of the therapeutically active ingredients.

Some 773 chemical agents have been approved by the Food and Drug Administration (FDA) for use as inactive ingredients in drug products.2 Inasmuch as these compounds are classified as “inactive,” no regulatory statutes require listing on product labeling. Pharmacopeial guidelines, enforceable under the Food, Drug, and Cosmetic Act, do require labeling of inactive ingredients for topical, ophthalmic, and parenteral preparations; orally administered products are currently exempt. Because of pressure from professional and consumer organizations asking the FDA to require complete disclosure of all ingredients, voluntary labeling was adopted by the two major pharmaceutical industry trade associations. These voluntary guidelines contain an exemption for “trade secret” components and do not require complete disclosure of all fragrance and flavoring ingredients.

Current problems encountered with “inactive” ingredients include benzalkonium chloride-induced bronchospasm from antiasthmatic drugs, aspartame-induced headache and seizures, saccharin-induced cross-sensitivity reactions in children with sulfonamide allergy, benzyl alcohol toxicity in neonates receiving high-dose continuous infusion with preserved medications, dye-related cross-reactions in children with aspirin intolerance, lactose-induced diarrhea, and propylene glycol-induced hyperosmolality and lactic acidosis. Although many other excipients have been implicated in causing adverse reactions, these are the most significant in the pediatric population.

It is readily appreciated that some percentage of asthmatic children will develop a “paradoxical” bronchospasm after they inhale their medication. Because many of these reactions were attributed to sulfite, which had been highly publicized as a causative agent, it was often first suspected. During the past 10 years, however, the active ingredient in sulfite-containing preparations, the nonselective 2-agonists isoproterenol, isoetharine, and metaproterenol, have been replaced as drugs of choice by more selective agents, primarily albuterol, that do not contain sulfites. Paradoxical reactions continue to be reported, in some cases resulting in product reformulation because of excessive adverse reactions. Inactive ingredients that have been implicated in causing these reactions include benzalkonium chloride, oleic acid, chlorofluorocarbons, soya lecithin, and sorbitan trioleate.


Sulfiting agents are widely used as antioxidants. Six sulfite compounds (sulfur dioxide, sodium sulfite, sodium bisulfite, potassium bisulfite, sodium metabisulfite, and potassium metabisulfite) have been categorized as “Generally Recognized as Safe” for use in foods and drugs. This status was revoked for raw fruits and vegetables (excluding potatoes) in 1986 after the FDA received reports of more than 250 cases of adverse reactions, including six deaths associated with the ingestion of sulfites in foods.3,4 Although primary exposure in children is through foods, serious reactions have also occurred after oral, inhalational, parenteral, and ophthalmic administration of sulfite-containing drugs.

Signs and symptoms most frequently reported include wheezing, dyspnea, and chest tightness in patients with known reactive airway disease.5-9 Nonimmunologic anaphylactoid reactions have also occurred.7,8,10,11 Reactions to sulfites rarely occur in patients without reactive airway disease.12 Metabisulfite hypersensitivity was demonstrated in 19 (66%) of 29 children with a history of chronic moderately severe asthma.13 The incidence of sulfite sensitivity increases with age in severely asthmatic children (31% of children up to 10 years of age and 71% of older children).14

The presence of sulfites in antiasthmatic medications has been a concern, but many of these medications have been reformulated or replaced in clinical practice by more -selective agents, which do not contain sulfites. Metered-dose aerosol bronchodilators do not contain sulfites. Nonsulfite-containing products used to treat asthma are presented in Table 1. Parenteral drugs, such as corticosteroids, aminoglycosides, and epinephrine, may contain sulfites (Table 2) but rarely produce reactions because of the small amounts present. Patients who react to oral challenges with small amounts (5 to 10 mg) are at risk for similar reactions from these parenteral agents.15 Local dermal reactions accompanied by eosinophilia have been reported after continuous infusion with dobutamine.16 Sulfite-preserved amino acids contained in most mixtures of total parenteral nutrition are a less commonly appreciated source. Nevertheless, life-threatening situations requiring the administration of epinephrine should be treated with sulfite-preserved epinephrine if no preservative-free product is available, even in very sensitive patients. The diagnosis of sulfite sensitivity is made by history and through challenge testing.7 Avoidance of foods containing sulfites through careful reading of packaged food labels and inquiry at restaurants as to the use of agents that contain sulfites may prevent reactions. A commercial sulfite-detection strip was found to be unreliable, especially when used on acidic foods or foods removed from their original containers.17 Drug manufacturers must disclose the presence of sulfites in product labeling.

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Some Medications Used by Asthmatics That Do Not Contain Sulfites

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Some Sulfite-containing Medications Used by Asthmatics

Benzalkonium Chloride

Benzalkonium chloride is a commonly used bactericidal preservative in albuterol and metaproterenol nebulizer solutions in the United States and in beclomethasone and ipratropium bromide nebulizer solutions in other countries. Inhalation of pure benzalkonium chloride causes reproducible, dose-related, cumulative bronchoconstriction, with a rapid onset and prolonged duration compared with sulfites. It is frequently accompanied by a cough and burning sensation and, occasionally, by facial flushing and pruritus. Bronchoconstriction is inhibited by concurrent treatment or pretreatment with 2-agonists and cromolyn sodium and partially by histamine1 antagonists.18-20 The mechanism appears to be non-IgE-mediated release of mast cell mediators, with atopic patients being more susceptible.21

Because the reaction is dose-related and cumulative and may be masked by the active agent in many patients, few clear-cut cases of paradoxical bronchoconstriction have been attributed to benzalkonium, primarily in patients using more than one agent containing this excipient or in those receiving frequent dosing.22-26 Unit-dose vials deliver five times as much benzalkonium as the same dose given from a multiple-dose vial, which resulted in one case of bronchoconstriction.26 Other potential sources of benzalkonium in children with asthma and concurrent sinusitis include nasal saline, nasal corticosteroid, and nasal decongestant solutions.

In several studies of adult asthmatics, the lowest dose of pure benzalkonium chloride that produced a 20% decrease in forced expiratory volume in 1 second ranged from 124 to 159 µg. Albuterol (from a multidose vial) contains 50 µg per 0.5 mL of solution18,19; thus, a single dose is unlikely to cause a reaction. Even in patients without overt deterioration after the use of benzalkonium-preserved antiasthmatic agents, some evidence exists that benzalkonium-free solutions may have improved efficacy.21,27 Thus, although the presence of benzalkonium probably has a minimal effect in most patients using single, infrequent doses of a preserved bronchodilator, development of a unit-dose, nonpreserved preparation may significantly benefit the severely ill, hospitalized patient in whom disease-related deterioration in pulmonary function may be difficult to distinguish from preservative toxicity.

Metered-dose Inhalers (MDIs)

Paradoxical bronchoconstriction has been reported in up to 6.9% of asthmatic patients after inhalation of pure MDI vehicle.28 When combined with an active ingredient, this incidence decreases to approximately 1.5% to 4%.29 Most studies of MDI-related bronchoconstriction have been confounded by the lack of testing of individual vehicle components, inherent irritability of some active ingredients (corticosteroids), or concurrent use of potent active ingredients (bronchodilators). Inactive ingredients that have been implicated in the deterioration of pulmonary function attributable to hypersensitivity or irritant effects include chlorofluorocarbons,30-33 sorbitan trioleate,30,34 oleic acid,28,35 and soya lecithin (H. G. Wilms, written communication, October 27, 1989).28,36 One metaproterenol product, reformulated to contain soya lecithin, was withdrawn from the market after 1 month because of escalating reports of coughing, gagging, and asthma exacerbation (H. G. Wilms, written communication, October 27, 1989).


Aspartame, a dipeptide of aspartic acid and a methyl ester of phenylalanine, is approved for use in pharmaceutical products and is being used increasingly in chewable tablet and sugar-free formulations. Labels for both prescription and nonprescription products must include the phenylalanine content. The major consideration in the use of aspartame in children is in patients with autosomal recessive phenylketonuria. Although heterozygotes do not appear to have clinically significant increases in phenylalanine after ingestion of even large amounts (equivalent to 24 12-oz cans of diet beverages), homozygotes with strict dietary restrictions should avoid aspartame. Children without dietary restrictions could safely ingest 10 mg/kg/d.37-40 Dietary consumption of aspartame is typically less than 5 mg/kg/d41; young children, however, could ingest considerably more. For example, a 2-year-old child weighing 12 kg consumes 17 mg/kg from drinking one 12-oz can of diet soda and one serving of a sweetened product (eg, cereal, pudding, gelatin, or frozen dessert).42

Headache is the most common adverse effect attributed to aspartame but is seldom confirmed by single-dose double-blind challenge. Up to 11% of patients with chronic migraine headaches reported headaches triggered by aspartame43; however, a double-blind challenge with three doses of 10 mg/kg given every 2 hours triggered no more headaches than did placebos in patients with vascular headaches believed to be exacerbated by aspartame.44 A small, double-blind 4-week trial showed an increase in frequency of headaches after ingestion of 1200 mg/d, indicating that a longer challenge period may be necessary.45

In anecdotal reports, aspartame has been linked to various neuropsychiatric disorders, including panic attacks, mood changes, visual hallucinations, manic episodes, and isolated dizziness.46-49 A small, double-blind crossover study of patients with major depression revealed a higher incidence of reactions in these patients compared with nondepressed volunteers after administration of 30 mg/kg for 7 days; symptoms included headache, nervousness, dizziness, memory impairment, nausea, temper outbursts, and depression.50 None of these conditions has been rigorously proven to be caused by aspartame, but carefully conducted double-blind challenges may be indicated in patients with histories that suggest aspartame as a cause. Patients with underlying mitral valve prolapse or affective disorders may be at increased risk for neuropsychiatric effects51; several studies have shown that individuals without psychiatric or seizure disorders do not demonstrate these effects.50,52

Seizures have been reported via passive surveillance data collected by the FDA and in a few case reports.47,48,53 A recent analysis of FDA reports showed 41 cases of rechallenge with a temporal relationship to aspartame consumption. Most seizures occurred in patients who had an acceptable dietary intake, except for a 16-year-old who ingested up to 57 mg/kg of aspartame.54 Aspartame is generally considered safe for children with epilepsy. One study found increased spike-wave discharges in children with untreated absence seizures after a high dose of aspartame and suggested that children with poorly controlled absence seizures avoid aspartame.55

Several studies have shown no relationship between aspartame and aggressive or hyperactive behaviors or cognitive function in children; thus, children with attention deficit disorder, with or without hyperactivity,56,57 do not need to avoid this sweetener.

Isolated confirmed hypersensitivity reactions resulting from ingestion of aspartame have been reported, including two patients who developed subcutaneous nodules or granulomas resembling erythema nodosum.58,59 Other reported reactions include orofacial granulomatosis, erythema, pruritus, urticaria, and angioedema.60-62 A meticulous workup with double-blind challenge usually fails to confirm the purported reaction; hypersensitivity reactions appear to be rare.63,64 These reactions may be related to breakdown products formed during the storage of liquid products, such as diketopiperazine derivatives, especially after exposures to higher temperatures.62 If so, rechallenge with fresh encapsulated powder could produce a false-negative reaction.


Many oral drugs, including both solid and liquid dosage forms, contain saccharin as a sweetening agent. Saccharin is not included in drug labeling. The most frequent use of saccharin is in foods and beverages, accounting for 70% of the total consumption. A British survey found that conventional soft drinks were the predominant source of saccharin in children aged 2 to 9 years, replaced by diet soft drinks in adolescents. The median intake of saccharin was 0.2 to 0.9 mg/kg/d in the general population and 0.6 to 2.3 mg/kg/d in diabetics.65 Foods containing saccharin must carry a label stating that the “use of this product may be hazardous to your health . . . contains saccharin which has been determined to cause cancer in laboratory animals.”

Saccharin may be present in drugs in substantial amounts. Ingestion of the recommended daily dosage of chewable aspirin or acetaminophen tablets in a school-age child would provide approximately the same amount of saccharin contained in one can of a diet soft drink. This amount, relative to the body weight of a child younger than 9 or 10 years, ingested for prolonged periods would be considered as “heavy use,” as defined in a major large-scale FDA/National Cancer Institute epidemiologic study.66 In this study, heavy use of artificial sweeteners was associated with a significantly increased risk for the development of bladder cancer. An independent review of this study concluded that there was no association.67 An investigation of saccharin performed by the American Medical Association in 1985 concluded that bladder changes were species-specific, were confined to the second generation of male rats, and occurred in association with large doses (equivalent to several hundred cans of diet soft drink per day). The no-effect level was equivalent to 500 mg/kg/d.68,69 Saccharin is not genotoxic; the presumed mechanism of toxicity is the binding of saccharin to urinary proteins (not normally found in humans), creating a nidus for the formation of silicate crystals, which are cytotoxic to bladder epithelium.70

Saccharin is an O-toluene sulfonamide derivative and causes similar dermatologic reactions. Cross-sensitivity with sulfonamides has been demonstrated; therefore, children with “sulfa” allergy should also avoid saccharin. Hypersensitivity can usually be confirmed by a radioallergosorbent test for saccharin.71 In a series of 42 patients with adverse effects resulting from consumption of saccharin in pharmaceutical agents, pruritus and urticaria were the most common reactions, followed by eczema, photosensitivity, and prurigo.72 Other reactions include wheezing, nausea, diarrhea, tongue blisters, tachycardia, fixed eruptions, headache, diuresis, and sensory neuropathy.73-77

Ingestion of saccharin-adulterated milk formula by infants was associated with irritability, hypertonia, insomnia, opisthotonos, and strabismus, which resolved within 36 hours after ingestion. Two anecdotal reports of an accidental overdose in an adult and a child discussed reactions of generalized edema, oliguria, and persistent albuminuria.75 Because of the paucity of data on the toxicity of saccharin in children, the American Medical Association has recommended limiting the intake of saccharin in young children and pregnant women.68

Benzyl alcohol is commonly used as a preservative in many injectable drugs and solutions. A number of neonatal deaths and severe respiratory and metabolic complications in low-birth-weight premature infants have been associated with use of this agent in bacteriostatic saline intravascular flush and endotracheal tube lavage solutions.78-80 In a controlled study, intraventricular hemorrhage, metabolic acidosis, and increased mortality were positively correlated with substantial benzoic acid and benzyl alcohol levels in neonates.81 The incidence of premature infant mortality, kernicterus, and intraventricular hemorrhage decreased markedly after discontinuation of preserved flush solutions.82-84 In surviving infants, exposure to benzyl alcohol was also found to be associated with morbidity, including cerebral palsy and developmental delay.83

Most therapeutic agents, other than large-volume fluids, contain amounts of benzyl alcohol smaller than those associated with neonatal death. The effects of lower amounts, however, have not been adequately studied (Table 3). Toxicity has been described in one infant weighing 3350 g who received 32 to 105 mg/kg/d.80 Continuous infusions of high doses of some medications containing benzyl alcohol, such as doxapram, may reach the range of benzyl alcohol dosage associated with toxicity in this case report. Premature infants receiving low doses in medications were found to have peak benzoic acid levels 10 times higher than those in term infants but without evidence of toxicity.85 Two studies noting the striking decrease in kernicterus after removal of benzyl alcohol did not reveal a dose-response relationship and could not exclude the possibility that other advances in therapy were responsible.84,86

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Parenteral Medications That Contain Benzyl Alcohol

The US Pharmacopeia requires labeling of bacteriostatic water and saline for injection with the phrase, “Not for use in newborns.” The FDA declined similar labeling for multidose parenteral medications, because serious toxic effects from benzyl alcohol had virtually disappeared.87 The toxic effects in newborns relate primarily to the use of preservative-containing flush solutions, which clearly are to be avoided in newborns. At low doses, such as those present when medications preserved with benzyl alcohol are administered, benzyl alcohol is safe for newborns.

Bacteriostatic saline solution containing benzyl alcohol was associated with severe bronchitis and hemoptysis when used to dilute albuterol for nebulization in an adult man.88 Nonpreserved saline solution should be used in children to dilute nebulized bronchodilators.

Benzyl alcohol may also rarely cause hypersensitivity reactions. Contact dermatitis,89 as well as more generalized allergic symptoms including nausea, fatigue, fever, maculopapular rash, or angioedema, may occur after parenteral administration of products containing benzyl alcohol as a preservative.90-92

Numerous dyes are used in pharmaceutical manufacturing. These dyes give products a distinctive, identifiable appearance, and they impart a uniform and attractive color to products that might otherwise be drab and unappealing or exhibit color variation among batches.

Several groups of dyes have been associated with serious adverse effects. The azo dye tartrazine (FD&C Yellow No. 5) is known to be potentially dangerous in aspirin-intolerant individuals. Approximately 2% to 20% of asthmatics are sensitive to aspirin. The incidence of cross-reaction to tartrazine was previously believed to be as high as 10%,93,94 but more recent carefully blinded studies have shown the incidence to be less than 2.4%.95-98 Unlike aspirin, tartrazine does not alter prostaglandin synthesis and does not, therefore, exert anti-inflammatory actions. Nonetheless, reactions to tartrazine are similar to those produced by aspirin, occur in patients both with and without a history of aspirin intolerance, and include acute bronchospasm, nonimmunologic urticaria, eosinophilia, and angioedema.94,99-107 Rarely, nonimmunologic anaphylactoid reactions occur.108,109 The most likely mechanism for these reactions is dose-related histamine release from mast cells.110,111 Patients with recurrent allergic vascular purpura may experience exacerbations after exposure to azo dyes, such as tartrazine, sunset yellow, and new coccine.112-114 Because of both the seriousness of these reactions and the widespread use of tartrazine in foods and over-the-counter and prescription drugs, since 1980 the FDA has required that all products containing tartrazine be labeled so that these substances can be avoided.115

Patients with the classic aspirin triad reaction (asthma, urticaria, and rhinitis) or anaphylactoid reactions may also develop similar reactions from dyes other than tartrazine, including amaranth,116-118 erythrosine,118,119 indigo carmine (FD&C Blue No. 2),103 ponceau,106,116,118 new coccine,113,117 sunset yellow,103,106,108,113,117,118 Brilliant Blue (FD&C Blue No. 1),106,118 methyl blue,120 quinolone yellow,121 and FD&C Red No. 40.122

Gastrointestinal intolerance, with abdominal pain, vomiting, and indigestion, has been associated with sunset yellow; in one case, eosinophilia and hives were also present.123,124 Other dermatologic reactions, including photosensitivity, erythroderma, and desquamation,125 have been attributed to erythrosine, an iodine-containing dye. By mandate, erythrosine has been removed from topical products and is being voluntarily removed from many oral drug products because of concerns about carcinogenicity.

Contact dermatitis has been associated with neutral red,126,127 D&C Yellow No. 11,128,129 indigo carmine (FD&C Blue No. 2),130 quinoline yellow,129 and gentian violet (CI Basic Violet No. 3).131,132

Dyes and other food additives have also been suggested as a cause or aggravating factor in some cases of hyperactivity in children116; carefully controlled trials133-136 and current opinion137-139 generally refute a possible association.

Because carefully controlled double-blind challenges often fail to confirm suspected reactions in children with atopic eczema,140 a controlled challenge is recommended before dyes are eliminated from the diet. Hypersensitive individuals should avoid dyes; liquid medications and nutritional supplements that do not contain dyes are listed in Table 4. These listings were originally compiled from voluntary responses to personal communications received from 56 US drug manufacturers and updated with a repeat mailing in December 1992. Until complete ingredient labeling is mandated, these lists will provide a tool to prevent reactions through avoidance in sensitive children using liquid dosage forms. Because inactive ingredients may change without changes in labeling, information in these tables should be verified.

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Examples of Dye-free Orally Administered Liquid Medications

Lactose (milk sugar) is widely used as a filler or diluent in tablets and capsules and to give bulk to powders. Lactase deficiency, occurring either as a rare congenital disorder or more commonly as an acquired lack of intestinal brush border disaccharidase, may lead to diarrhea, abdominal cramping, bloating, and flatulence after ingestion of milk products or lactose. These effects are produced either by lactic acid formed in the intestine by bacteria from undigested lactose or by a high intestinal osmotic load caused by unabsorbed carbohydrate with production of carbon dioxide and hydrogen gas by bacterial fermentation.141 Lactose intolerance in infants and young children may be associated with severe, prolonged diarrhea complicated by bacterial proliferation in the small bowel, dehydration, and metabolic acidosis.142 Lactose may be detrimental to the galactose-intolerant infant.

Late-onset lactase deficiency (adult hypolactasia) is a common disorder. Approximately 90% of adult American blacks and 60% to 80% of Mexican-Americans, Native Americans, Asians, and most Middle Eastern and Mediterranean populations have abnormal findings on lactose tolerance tests.143-148 Approximately 10% of the white population with Scandinavian or European ancestry is affected.148 Lactase deficiency may develop sporadically in otherwise tolerant individuals while they are suffering from an intestinal disease, such as tropical sprue or acute gastroenteritis.149

Sensitivity to lactose varies widely in severity, although some individuals (adults and children) may experience diarrhea, gaseousness, or cramping after ingestion of as little as 3 g or less of lactose.150,151 Such symptoms can occur in sensitive individuals after ingestion of drugs containing lactose.152-154 Two adult asthmatics who developed bronchospasm from lactose-containing medications had positive double-blind challenges with 300 and 500 mg of lactose.155,156

Propylene glycol is commonly used as a drug solubilizer in topical, oral, and injectable medications.

Absorption of the agent from creams applied to burns157,158 and injection of multivitamin products or enoximone (a phosphodiesterase inhibitor) in infants has resulted in serum hyperosmolality,159,160 which was associated with cardiorespiratory arrest in one case.160 Neonates have a longer propylene glycol half-life (16.9 hours) compared with adults (5 hours).158,159 Although the use of a multivitamin containing propylene glycol correlated strongly with serum osmolality in very low-birth-weight premature infants,161 propylene glycol from phenobarbital injection contributed an insignificant amount to the osmolar gap in another study.162 The higher amount of propylene glycol contained in an intravenous multivitamin product delivering 3 g/d was associated with a higher incidence of seizures in these infants compared with those receiving lower doses from an alternative product delivering 300 mg/d.163 Hyperosmolality related to topical propylene glycol occurred in 9 of 262 hospitalized burn patients.164

Because propylene glycol is metabolized to lactic acid, lactic acidosis may occur.165 Hemolysis, central nervous system depression, hyperosmolality, and lactic acidosis have been reported after intravenous administration.165-168 Hyperlactemia is associated with high propylene glycol levels, usually in patients with renal insufficiency, and is generally of minor clinical importance.169 Rapid infusion of concentrated propylene glycol-containing drugs has also been associated with respiratory depression, arrhythmias, hypotension, and seizures.170 Inadvertent administration of a highly concentrated solution can occur during manual push infusions; a piggyback infusion is preferred.171 Seizures and respiratory depression have also occurred in children who have ingested oral liquid medications containing propylene glycol.172,173

Several cases of localized contact dermatitis from the application of propylene glycol as a vehicle to skin or mucous membranes have been reported.174-180 In a series of 487 patients with eczematous contact dermatitis, 4.5% were found to be sensitive to propylene glycol.181 Oral or parenteral administration may exacerbate dermatitis in sensitized patients.182,183 The high concentration of propylene glycol contained in certain drug products, such as phenytoin, diazepam, digoxin, and etomidate, may induce thrombophlebitis when administered intravenously.184,185 In one study, 22% of patients experienced venous reactions to etomidate in propylene glycol, with no reactions to etomidate lipid emulsion.186


In a previous review of inactive ingredients, the American Academy of Pediatrics recommended mandatory labeling of inactive ingredients for all prescription and over-the-counter products. Since voluntary labeling was adopted, the legislative push for mandatory labeling has been abandoned, other than for nutritional supplements. A recently published survey of labeling on 102 chewable and liquid pediatric preparations found that only 90% labeled sweeteners, 80% labeled dyes and coloring agents, and 65% labeled preservatives. Although 90% of the preparations labeled flavorings, few provided the specific ingredient, in accordance with the voluntary guidelines.187 Therefore, the voluntary system is clearly inadequate. Again, the American Academy of Pediatrics recommends mandatory labeling for all prescription and over-the-counter drugs.

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