Dateline
August 22, 1995
BITTER PILL
Announcer: From Studio 3B in New York, here is Jane Pauley.
JANE PAULEY: Good evening. They were just trying to live healthier lives, so, instead of taking prescription and over-the-counter drugs, they tried one of those natural alternatives you find in the health food store--a product you may have tried yourself. What they got, they say, was a nightmare in a bottle.
And as Jon Scott reports, there was nothing natural about what happened next.
Ms. SOOTIE YORK: (Voiceover) It feels like lava inside my bones.
JON SCOTT reporting: (Voiceover) Sootie York's body is at war with itself.
(Mr. York wheeling Sootie in wheelchair down the street)
Ms. YORK: My arms and legs are in a state of severe atrophy.
SCOTT: (Voiceover) Her white blood cells, which normally attack invading parasites, now devour her own tissue.
(The Yorks going down the street)
Mr. BOB MARTELL: My body was breaking out in rashes.
SCOTT: (Voiceover) Bob Martell understands the excruciating pain.
(Mr. Martell taking his blood pressure)
Mr. MARTELL: My skin had a crawling feeling, like there was a bug walking across my skin.
SCOTT: (Voiceover) He suffers every day from the same disease.
(IV drip)
Mr. MARTELL: I've had burning pain, stabbing pain, shooting pains. I've hurt so bad, I can remember standing in a doorway and just pushing my shoulder into the wall, just to distract myself from the pain, tears running down my face, just wondering how I was going to make it through the next hour.
Ms. YORK: I took L-tryptophan for three months, in 1989, when the epidemic occurred...
SCOTT: (Voiceover) Bob, Sootie, and the other members of this support group have a rare but debilitating disease called EMS--eosinophilia myalgia syndrome.
The Centers for Disease Control estimates that more than 5,000 Americans got sick from taking certain brands of a health supplement called L-tryptophan, once sold over the counter in drug and health food stores.
(Support group meeting; bottles of L-tryptophan; druggist)
SCOTT: You thought you were taking this nutritional supplement that essentially came from some food product.
Ms. YORK: Right, and that is not what I was taking at all. This was something made in--genetically made in a laboratory.
SCOTT: (Voiceover) In fact, L-tryptophan is an amino acid naturally found in foods like turkey and milk. Packaged in pills and powders, it exploded on the US market during the 1980s. It was billed as a natural wonder product that could treat everything from insomnia and depression to anxiety and premenstrual syndrome. But what Sootie York and thousands of other Americans did not know was that something was very wrong with the L-tryptophan they were taking.
(L-tryptophan bottles; newspaper clippings; support group members)
Mr. DON SILVA: I think about her every day, and it hurts. And I think it will always hurt.
SCOTT: (Voiceover) Don Silva's wife, Audre, began taking L-tryptophan in the summer of 1989 to help her sleep. Then in September of that year, Audre became very sick. Her daughter Jill:
(Photos of Audre with members of her family)
JILL: From the first onset of sickness, it took about two to three months and she was totally incapacitated.
SCOTT: (Voiceover) By November of 1989, Audre was one of a growing number of victims of a mysterious disease showing up all over the country.
(Silva talking to woman in hospital bed)
Unidentified Doctor: I want you to try to lift your hand up for me again, OK?
SCOTT: (Voiceover) Doctors were perplexed. They didn't know how to treat this illness...
(Doctor examining patient)
Doctor: Can you try on the side now?
SCOTT: (Voiceover)...or how to counsel its victims. They only knew that virtually every one afflicted had taken L-tryptophan manufactured by a huge Japanese petrochemical company called Showa Denko. Showa Denko is not known as a pharmaceutical company. Most of its business comes from oil refining and chemical manufacturing. In fact, L-tryptophan was one of the few food products it ever made.
Not only do many victims of Showa Denko's L-tryptophan suffer from a long list of ailments...
(L-tryptophan victim; Showa Denko building; IV drip; Martell and nurse)
Unidentified Nurse: What about the pain?
Mr. MARTELL: Yeah.
SCOTT: (Voiceover) Some of them have also lost their jobs and financial security.
Ms. YORK: (Voiceover) We're broke. We've gone through all of our savings accounts...
(Martell; York working with physical therapist in pool)
Ms. YORK: ...all of our CDs, the--all of the children's college funds. All of these to pay the bills that the major medical has not paid.
SCOTT: (Voiceover) The terrible irony is that people like Sootie York and Bob Martell only tried L-tryptophan to avoid taking prescription drugs. Now they must endure countless medical treatments, up to 20 different medications every day, which they say aren't helping very much.
(Martell taking medicine; medicine bottles; York and Scott with plate full of pills)
Mr. MARTELL: I personally have not met anybody that has gotten better from this disease.
SCOTT: (Voiceover) And some EMS victims have died. Audre Silva's family says she took no more than 15 pills, was soon bedridden and died on Christmas morning, 1990.
(Photo of Silvas dancing; Don Silva talking to Audre in hospital bed; Don Silva in front of Audre's grave)
SCOTT: If she had never taken L-tryptophan, would your mother be alive today?
JILL: Yes.
Mr. SILVA: Absolutely.
SCOTT: No question in your mind.
Mr. SILVA: Yeah. I don't see any question. She did all the right things.
SCOTT: Not everyone who took L-tryptophan got sick. Some victims showed only mild symptoms of EMS, and others seemed to improve over time. Still, the Centers for Disease Control confirms that at least 36 Americans died from taking L-tryptophan, and no one has found a cure.
But DATELINE has uncovered a series of internal Showa Denko documents which reveal the company knew something was wrong with its L-tryptophan long before it was shipped to the United States.
Is this a case in which a company knowingly marketed a bad product in the US?
Dr. LESLIE SWEIGERT: I would--I would have to say yes.
SCOTT: (Voiceover) Dr. Leslie Sweigert investigated the EMS outbreak for the Centers for Disease Control. Now she often testifies as an expert witness on behalf of EMS victims.
(CDC buildings; Sweigert walking down the street)
Dr. SWEIGERT: They knew that they were making decisions that could potentially cause their product to be dangerous.
SCOTT: (Voiceover) The problems began in the 1980s when Showa Denko made a decision to sell L-tryptophan as a health food.
(Showa Denko building; bottles of L-tryptophan)
Dr. SWEIGERT: They investigated the health food industry in the United States, saw that there was potential there to skirt regulations of drugs by marketing it as a health food, but promoting it for drug uses.
SCOTT: (Voiceover) This document shows that Showa Denko figured it would take seven years and $4 million to get L-tryptophan on the market as a drug, but only six to seven months and $300,000 to market it as a health food.
TEXT:
7 years to develop L-Trp as a pharmaceutical product
The development time is 6 - 7 months
(Showa Denko documents)
SCOTT: (Voiceover) In the US, health foods don't need the approval of the Food and Drug Administration. They don't need to be proven safe or as effective as drugs. And documents show that when Showa Denko held a meeting to discuss marketing L-tryptophan as a drug, even company insiders doubted that when put to the test their product could pass. Quote, "It is difficult to demonstrate the superiority of this drug, and it cannot be concluded that this drug causes fewer side effects. It is better to regard it as a food additive."
(FDA building; Showa Denko building; documents)
Dr. SWEIGERT: It didn't really matter to them if it didn't cause fewer side effects and maybe even caused more side effects. They chose to continue marketing it to the American public for the economic benefit of exploiting that industry.
SCOTT: (Voiceover) By April of 1988, business was booming. Americans were buying L-trypytophan in record numbers. A Showa Denko document called the sales a `divine wind.' But in the summer of 1988, Showa Denko got a very troubling letter from a Germany company saying it had found an impurity in Showa Denko's L-tryptophan.
(L-tryptophan bottles; document; German laboratory)
SCOTT: This document is something that Showa Denko produced after the Germans alerted them to the impurity in the product. What does that say about their research into the impurity?
Dr. SWEIGERT: The key comment in here is that Showa Denko admits that they can't determine a lack of toxicity for the impurity because they can't figure out what the impurity is.
TEXT: toxicity of impurity still remains unclear
SCOTT: (Voiceover) That document was dated November 8th, 1988, a full year before the EMS outbreak in America. So they were putting a product out on the market knowing that it had an impurity, but they didn't even know what the impurity was?
(Document; York sleeping and daughter covering her with a blanket)
Dr. SWEIGERT: Right. I--I want to stress it's not an impurity. They know that it's got several impurities.
SCOTT: Impurities in a natural health food. It's easier to understand how that could happen when you learn that Showa Denko was using a highly scientific method to manufacture a product that was not pure and far from natural.
Dr. SWEIGERT: They were taking a bacteria that happened to produce a lot of tryptophan and fermenting it. And then, to top it off, genetic engineering was also being used on that bacteria to make it better and better at making the tryptophan.
SCOTT: (Voiceover) What happened next was critical. According to medical reports, some important changes took place. Beginning in December of 1988,
Showa Denko introduced a new genetically modified strain of bacteria to boost production of its L-tryptophan. Then, incredibly, in 1989, some batches of L-tryptophan were run through only half the amount of carbon filtration normally used to purify the product. And some L-tryptophan, processed from October of '88 to June, 1988, bypassed an important filtration step altogether.
Showa Denko would not tell us why, but Dr. Sweigert has a theory.
(L-tryptophan tablets; Showa Denko building)
Dr. SWEIGERT: Every time the product has to pass through a purification step, you not only lose impurities, you lose some of the product that you want to sell. So that makes your process less productive and less profitable.
SCOTT: Bottom line, this shows in November of '88 that they knew ways to make their product more pure.
Dr. SWEIGERT: Correct.
SCOTT: Did they do that?
Dr. SWEIGERT: Well, actually, they did exactly the opposite.
SCOTT: (Voiceover) And remember the German company that found that impurity in the Showa Denko L-tryptophan? Well, Showa Denko answered by issuing this report saying it had modified its refining process for the removal of the impurity. A Showa Denko executive wrote this memo stating, "This requires notification to authorities in every country." The response--it should be kept confidential.
(German company; parking lot; documents)
SCOTT: Do you call that a cover-up?
Dr. SWEIGERT: They--they certainly are not being forthcoming.
SCOTT: (Voiceover) Once again, all of this took place before the altered Showa Denko L-tryptophan arrived on the American market, before the spring and summer of 1989 when Bob Martell, Sootie York, and Audre Silva bought it.
JILL: (Voiceover) She thought it would help her to sleep, and it killed her.
SCOTT: (Voiceover) By November, the EMS outbreak was raging, and L-tryptophan was pulled from the market.
(Bottles of L-tryptophan; Silva and daughter with Audre in hospital; druggist pulling bottles off of shelf)
SCOTT: Several independent medical reports have concluded that the EMS epidemic was caused by contaminated L-tryptophan, although research still don't know precisely which contaminant was responsible.
We wanted to ask Showa Denko about this, but the company declined our request for an interview. Instead, it sent us this position paper. It reads, "The cause of EMS remains unknown. Showa Denko had every reason to believe its product was safe. L-tryptophan manufactured by Showa Denko met all the purity standards of the United States, and had been subjected to extensive testing in animals."
But American doctors who have studied the disease, and one who even toured the factory where Showa Denko produced its L-tryptophan, confirmed the company never tested its product on people after it made so many changes.
Dr. SWEIGERT: They marketed their product worldwide, knowing that it had impurities in it. And essentially used the entire population that was buying L-tryptophan as a test population.
Unidentified Researcher: Right there. So these three peaks said Showa Denko....
SCOTT: (Voiceover) In the years following the EMS outbreak, Showa Denko has supported research in the disease at the Mayo Clinic and continues to settle lawsuits filed by thousands of Americans who got sick after taking L-tryptophan. But that's little comfort to those that believe the epidemic never should have happened at all.
(Mayo Clinic; EMS sufferers; Audre Silva)
JILL: And I can also remember a moment when my mother looked at me and wanted to know why and who the heck would have done anything like that to human beings knowingly?
Mr. MARTELL: They knew something was wrong with this product. There should have been a recall. There should have been some warning before this all happened.
SCOTT: (Voiceover) Five years after the EMS outbreak, no government agency tests the hundreds, if not thousands of health foods on the market. And FDA officials say it has gotten somewhat more difficult to protect Americans from potentially dangerous supplements. Under a law passed last year, the FDA now has to prove a health food is unsafe before it can be taken off store shelves.
(Bottle-filled shelves in health food store; HHS building)
Dr. SWEIGERT: I think people believe if it makes it to the shelf and they can buy it, that, for some reason it's--it's been inspected and dangers have been ruled out. And that is not the case.
SCOTT: Could this happen again?
Dr. SWEIGERT: Oh, absolutely. I'm afraid it--I'm afraid it will happen again.
PAULEY: L-tryptophan is still banned from sale in the US, although there is an effort by some to have that ban lifted. Both Sootie York and the family of Audre Silva have settled their lawsuits against Showa Denko. Bob Martell continues to fight his, and tells DATELINE his health has gotten worse since we did our interview.