[Homestead] Drugs are drugs are drugs

Tvoivozhd tvoivozd at infionline.net
Sun Sep 5 11:59:08 EDT 2004


Calling drugs herbal remedies doesn't make them less lethal.  Lack of 
regulation guarantees some of them will kill you.  When you have 
thousands of  faceless compounders cranking out marvelous "Herbal 
Remedies"" in their back bedroom , completely without any verification 
of contents, you never know what you get.  The only herbal remedies you 
can trust are those you grow in your backyard and used according to the 
Graedon book on herbals.

	

*washingtonpost.com* <http://www.washingtonpost.com/>
*Herbal Remedies Turn Deadly for Patients*
Suits Fail to Bring Tougher Rules

By Justin Gillis
Washington Post Staff Writer
Sunday, September 5, 2004; Page A01

When a medical checkup indicated trouble with his prostate gland, John 
Meyer decided to try a natural remedy. Ignoring his wife's skepticism, 
the southern Arizona man went out and bought an herbal supplement 
promoting "prostate health."

Murray Berk, a Long Island garment buyer, did the same thing when he was 
diagnosed with prostate cancer. "I thought it was great there was a 
natural product available," said his daughter, Shelley Martin.

The two men wound up taking the same herbal remedy, a substance called 
PC-SPES. Today both men are dead.

Their relatives blame the herbal supplement and the California company 
that made it. Batches of PC-SPES, it turned out, had been improperly 
mixed with pharmaceuticals, including an anti-inflammatory drug, an 
artificial estrogen considered so dangerous it was pulled from the 
market years ago, and a blood thinner that in high doses is used as rat 
poison.

The company, operating under the name BotanicLab, sold at least eight 
other herbal supplements that eventually proved to contain undisclosed 
prescription drugs. Those products are now off the market, and 
BotanicLab has closed. The company pleaded no contest to a felony charge 
for selling contaminated goods and three owners pleaded no contest to 
misdemeanor charges. Company executives declined to discuss the 
adulteration.

While BotanicLab may be history, the regulatory system that allowed the 
company to go into business with little oversight has not changed much. 
The government subjects herbal remedies to far less scrutiny than 
pharmaceuticals, a hands-off policy that has allowed the $20 billion 
supplement industry to flourish, growing to 1,000 manufacturers shipping 
29,000 products.

Polls show most Americans think the products are safe and assume the 
government is testing them to be sure. In fact, strapped regulators at 
the Food and Drug Administration said they have typically conducted only 
100 or so inspections a year, though they hope to step that up.

Congress mandated a light regulatory touch in the mid-1990s, after 
industry lobbyists stoked public concerns that the government was going 
to put new restrictions on common vitamins and natural remedies used for 
generations. Lawmakers have since begun to reassess that approach after 
the Food and Drug Administration last year moved to ban the use of the 
herbal stimulant ephedra and the bodybuilding supplement androstenedione 
in response to rising health concerns.

The BotanicLab disaster offers a detailed case study in how dangerous 
herbal remedies can be hyped on the Internet, embraced by desperate 
patients and legitimized by research institutions in ways that put lives 
at risk.

Many of the most exaggerated health claims about PC-SPES were made not 
on the bottle's label, where they would be subject to federal 
regulations, but on the Internet, where free-speech laws give people 
wide latitude to discuss the virtues and drawbacks of any issue. The 
glowing commentary apparently hit home with people reluctant to rely on 
traditional treatments, or for whom those had failed.

PC-SPES also gained popularity after some of the nation's premier cancer 
centers backed BotanicLab's flagship product and recommended it to 
patients. Top medical journals published studies touting the potential 
benefits of the remedy, studies they have yet to retract.

The adulteration was ultimately rooted out not by the major cancer 
centers endorsing PC-SPES, but by suspicious patients scraping up money 
to run their own tests.

Research on PC-SPES received critical financing from several outside 
sources, including $2.1 million in U.S. government money. Early funding 
also came from a prostate-cancer foundation created by Michael Milken, 
the convicted junk-bond financier who has become an influential voice in 
cancer politics in Washington.

Though BotanicLab shut down two years ago, new details about the 
disaster continue to emerge as a string of lawsuits in California and 
New York unfold against the company, its distributors and other parties.

Thirty-five people or their estates have come forward to claim harm, 
including men whose breasts grew so large they had to have them 
surgically removed, and others who inexplicably bled to death. Lawyers 
for the injured claim there may be hundreds of other victims in North 
America and Europe.

Whether any injuries can be linked to intentional adulteration remains 
to be seen. BotanicLab has at various times asserted that the 
adulteration of its products occurred among the Chinese suppliers of the 
raw ingredients and it should not be held responsible. Attorneys for the 
company and several defendants have also said in court that the 
purported victims are exaggerating their injuries.

This account of the BotanicLab saga is based on a review of more than 
11,000 pages of documents that have surfaced during the legal action, 
and on interviews in Washington, New York and California. Newsday and 
several major newspapers reported some aspects of the story as it 
evolved, and significant details were first reported in the Cancer 
Letter, a Washington publication. Its editor, Paul Goldberg, and 
publisher, Kirsten Boyd Goldberg, made some of their files available.

David Markham, a San Diego attorney representing some victims in the 
case, estimated that BotanicLab may have taken in as much as $50 million 
before it was shut down.

"The big question," Markham said, "is why did it take five years for law 
enforcement in the United States to figure this out?"

*Early Promise
*

The scientific brain behind BotanicLab was Sophie Chen, an immigrant 
from Taiwan who went to college in the United States and then pursued a 
conventional career in chemistry, working at several large drug 
companies. In the early 1990s, she struck out on her own, telling people 
she wanted to try to marry Western medicine with Chinese herbal remedies.

Her scientific collaborator was Xuhui "Allan" Wang, an herbalist who 
liked to tell people he was a descendant of the doctor who served the 
last emperor of China. As Chen told the tale, the pair drew on the 
ancient wisdom of Chinese herbologists to combine Asian and a few 
American herbs into proprietary mixtures to treat conditions like 
prostate cancer, arthritis and others. They won U.S. patents on at least 
two blends.

The remedies became the core products of International Medical Research 
Inc., which did business under the name BotanicLab. Chen and associates 
in California, including her brother John Chen, set up the company in 
the Los Angeles suburb of Brea. Their timing was good: American interest 
in alternative medicine was rising in the 1990s.

What's more, the products could be put on the market relatively quickly. 
The herbal supplements did not have to undergo tests in humans because 
the company was not promoting them on the label as treatments for 
specific diseases.

Instead, the labels on various remedies touted support for "healthy 
joints" or offered "immune system enhancing properties." The Chens hit 
upon their biggest success with a supplement they called PC-SPES, 
labeled for "healthy prostate function."

/Spes/ is the Latin word for hope, and the buzz on the Internet was that 
"PC" stood for prostate cancer. The product was billed as a combination 
of six Chinese herbs, one Chinese mushroom and an American herb.

PC-SPES showed early promise. Men with slow-growing prostate cancer pay 
close attention to the levels of a protein in their blood that may 
indicate whether their disease is spreading. Those who took the remedy 
reported that levels dropped sharply. True, it was quite expensive for 
an herbal remedy, as much as $500 a month, but many patients saw PC-SPES 
as worth it.

Chen told people she wanted to seek FDA approval to label the supplement 
as a prostate-cancer treatment, making it the nation's first formally 
sanctioned herbal remedy. That meant tests would be required, even 
though the product was already being sold in stores. Milken's 
prostate-cancer foundation provided Chen with two grants.

Other doctors launched small-scale studies. Then in 1998, the New 
England Journal of Medicine published a study led by Robert DiPaola, a 
researcher at the Cancer Institute of New Jersey, that suggested there 
really was something to the herbal formula. Leading institutions, 
including Johns Hopkins University, began gearing up for larger trials.

The National Center for Complementary and Alternative Medicine -- a unit 
of the National Institutes of Health, created at the behest of 
congressmen who support alternative medicine -- was looking for herbal 
remedies that might have some merit, and PC-SPES seemed like a top 
candidate. The agency began awarding grants.

BotanicLab's treatment was even featured in a 1999 book, "The Herbal 
Remedy for Prostate Cancer," by James Lewis Jr., a prostate cancer 
survivor and education professor who wrote several books about his 
personal battle and the disease. The book is still listed on 
Amazon.com's Web site, which features glowing reviews.

*A Troublesome Mix
*

To all outward appearances BotanicLab was a roaring success by the year 
2000. But behind the buff concrete walls and smoked-glass windows of the 
company's office in Brea, trouble was brewing.

The company was churning through a string of chief executives. One of 
these was a Harvard Business School graduate, Reed M. Benet, with 
special expertise in founding and expanding young natural-products 
companies. Hired in 2000, he said he was drawn by the company's sales 
growth of 40 percent a year and by the buzz he heard about BotanicLab's 
products and their promise against cancer. He said he was particularly 
impressed that the product was being tested in the laboratory of Eric 
Small, a top prostate-cancer researcher at the University of California 
at San Francisco.

Benet said he didn't entirely realize what he had taken on until he 
moved to Southern California. On one of his first days on the job, he 
said, he walked into a room where bulk herbs were stored and mixed. He 
found none of the paraphernalia of a modern company producing a consumer 
product -- no bar codes, no quality-control manual.

"It was a room full of boxes with mahogany-colored slats bound together 
with twisted wire, with Chinese letters on the boxes," Benet said in an 
interview in San Francisco, where he lives now. "Everything looked like 
it could have been carried in there by a camel 100 years ago on the 
spice road. I started realizing, 'Oh, my God -- what have I gotten 
myself into?' "

Benet said he went into the job knowing standards in producing 
nutritional products were less rigorous than those used in 
pharmaceuticals, but he still worried about the origin of the bulk 
herbs, which came from an array of Chinese suppliers. BotanicLab had 
bought a machine for its Brea site to help test product ingredients, but 
Benet said he could never get approval and funding to operate it.

Benet said that he advocated strict quality control and other measures, 
to no avail. After repeated clashes and growing doubts of his own, he 
said, he finally resigned in 2001.

Benet said he never saw anything at the company to suggest it was 
spiking its products with pharmaceuticals. But tests that the company 
itself ordered, after Benet left and the company came under pressure 
from California regulators in 2002, showed that bulk herbs coming into 
the country were free of pharmaceuticals, while packaged products 
leaving the Brea facility were adulterated with them. In addition, tests 
conducted after BotanicLab shut down have shown changes in the 
pharmaceutical ingredients over time that the people suing BotanicLab 
regard as evidence of a conscious effort to manage troublesome side 
effects.

Stephen H. Smith, a Los Angeles attorney representing multiple 
defendants, including the company, John Chen and Wang, pledged in an 
e-mail message on July 8 to answer queries about BotanicLab, but then 
failed to respond to multiple follow-up calls or to a set of written 
questions sent to him by fax and e-mail.

In two brief telephone interviews, Sophie Chen declined to discuss 
BotanicLab, the product adulteration or issues related to quality 
control in detail. But she did assert that she was not personally 
involved in mixing the company's products, saying she spent most of her 
time doing research in New York. She accepted no responsibility for the 
problems some patients now attribute to BotanicLab products. She said 
she pleaded no-contest to a criminal charge because she didn't have the 
money to fight it.

"I am just a scientist," Chen said. "I am only trying to find a cure for 
cancer."

*Serious Side Effects
*

 From the outset, doctors noticed that for an herbal remedy, PC-SPES had 
some odd properties.

Published studies showed that some of the men who took it got enlarged 
breasts, their nipples grew tender, their penises shrank, and they 
developed other problems. To some doctors, the side effects bore a 
curious similarity to the effects of another prostate cancer treatment: 
Users of PC-SPES showed signs of being on artificial estrogen therapy.

Prostate cancer arises in a male sex organ and grows under the influence 
of testosterone, the male hormone. It can therefore be suppressed, to a 
degree, by suppression of testosterone (a standard treatment today) or 
by administration of artificial forms of the female hormone, estrogen 
(an older, less popular form of treatment).

As part of his early study of PC-SPES, DiPaola, the New Jersey cancer 
doctor, tested the product for artificial estrogens. But any herbal 
mixture potentially contains thousands of chemical compounds, and 
analytical chemists said that finding an artificial drug among them can 
be difficult. DiPaola and his collaborators got results strongly 
suggesting an estrogen in the mix, but they couldn't figure out what it was.

The DiPaola group included the test results in their paper and urged 
caution in using PC-SPES, but in practice, it appears, other cancer 
doctors overlooked the lingering mystery and took the paper as a green 
light to recommend PC-SPES to their patients. DiPaola initially agreed 
to an interview about his testing of PC-SPES, but subsequently canceled 
it and declined to take questions; an aide said that administrators at 
his institution had ordered him not to talk because of the pending lawsuits.

Problems like enlarged breasts in men were strange but manageable. But 
then doctors began publishing comments in their studies about a more 
worrisome side effect: blood clotting. This, too, is a classic side 
effect of treatment with artificial estrogen, and a potentially deadly 
one. A clot in, say, a leg can break away and lodge in a vital organ, 
killing the patient.

JoAnne Meyer of Sonoita, Ariz., suspects PC-SPES caused the clot that 
killed her husband, John.

Meyer was a relatively healthy 64-year-old in 1998 when he learned he 
had an enlarged prostate gland. That's a benign condition, treatable 
with standard medical care, but John Meyer wanted to try natural 
remedies first. His wife had always scoffed at his interest in herbs, 
figuring he was wasting money, but she never imagined they would hurt him.

Though PC-SPES was mostly used by men with prostate cancer, it wasn't 
labeled that way, and Meyer apparently took the product's claims -- for 
"prostate health" -- at face value. Soon after starting the product, he 
contracted a serious leg problem that JoAnne Meyer now believes was a 
large blood clot. He was laid up for months, but felt well enough on 
Sept. 14, 1998, to try to get some yard work done while his wife was out.

"When I came back I found him dead over at the barn," Meyer said. An 
autopsy showed that blood clots had broken loose and lodged in his heart 
and lungs.

*Echoes of Another Error
*

While PC-SPES was widely touted on the Internet, a few prostate-cancer 
patients who posted regular comments there were wary. In particular, 
some of them said in public postings, the side effects of PC-SPES struck 
them as resembling the side effects of a cheap artificial estrogen 
called diethylstilbestrol, better known as DES.

DES was at the center of one of the great medical disasters of the 20th 
century. The drug was given to pregnant women in the United States for 
three decades, beginning in the 1940s, to prevent miscarriages. Not only 
was it ineffective, later studies showed, but it caused cancer in the 
daughters of mothers who took it, and it caused genital abnormalities in 
both their daughters and sons. The drug was pulled from the market in 1971.

The drug was also tested as a prostate-cancer treatment, but it produced 
so many side effects, including blood clots, that most doctors concluded 
it would do more harm than good. It was largely discarded, but interest 
in it has cropped up from time to time because of scattered research 
showing it might work at low doses.

Public suspicions that PC-SPES might be contaminated with DES prompted 
the FDA's office in California to test the product in August 2000. But 
an e-mail from an FDA chemist that has come to light in the lawsuits 
showed that the agency used a protocol capable of detecting only high 
doses of DES, and none was found.

Elizabeth Keville, director of the FDA laboratory in California that 
conducted the test, said her scientists looked for relatively high 
levels of DES based on information they received from a consumer who had 
filed a complaint with the agency. If the scientists had known to look 
for lower levels, they would have conducted the test differently, she said.

"You've got to make certain assumptions" when running a test, Keville 
said. "We certainly would not have been looking at those higher levels 
had we been told it's trace contaminants. . . . When we look back, yes, 
perhaps things could have been done differently."

The FDA's failure to find DES became marketing fodder for BotanicLab, 
which posted the results on its Web site. Then, in 2001, some men 
noticed the PC-SPES suddenly stopped working for them -- levels of the 
indicator protein started rising to worrisome levels. Moreover, a few 
men taking the drug started to turn up in hospital emergency rooms, 
bleeding profusely beneath the skin and from various orifices -- the 
very opposite of the earlier blood clots.

Communicating over the Internet, patients tried to link various medical 
problems to specific batches of PC-SPES. One of the key figures in 
assembling this jigsaw puzzle was a Connecticut woman named Susan Domizi.

Her husband, David, had taken PC-SPES with good results. But it 
inexplicably stopped working for him in 2001, and she wanted to find out 
why. With a manufacturing background, she knew to ask about product lot 
numbers and quality control.

She decided to have various batches of the remedy tested for DES 
adulteration. The Domizis were vacationing at a family home on 
Maryland's Eastern Shore when she learned the results: The effective 
lots of PC-SPES had tested positive for DES adulteration at low levels, 
and the more recent, ineffective lots had tested negative.

Domizi knew she had to go public, but she feared the reaction, since 
PC-SPES had acquired a passionate following among men with prostate cancer.

"I didn't sleep for about 24 hours," she said. "I knew that any 
accusation would be greeted by the majority of men with horror and anger."

*Added Evidence
*

She was right. Domizi posted her results, then linked up with men in 
California who paid for a second study, by Rocky Mountain Instrumental 
Laboratories, that confirmed her test. She was bombarded by e-mail, 
including death threats, from PC-SPES fans, but doctors couldn't ignore 
the accumulating evidence.

That October, a serious bleeding case came to public attention when two 
doctors working in Seattle, Mark Weinrobe and Bruce Montgomery, 
published a case report in the New England Journal of Medicine. Their 
patient, a traveling salesman, had turned up in an emergency room in 
Idaho bleeding from every orifice, and the hospital had barely saved him.

The state of California launched an investigation in January 2002 and 
eventually found DES in the same lot studied by the FDA. Meanwhile, 
Small, the University of California at San Francisco researcher who had 
been testing PC-SPES in patients, ordered separate tests in early 2002 
that confirmed DES adulteration, and he halted a human study of PC-SPES. 
Soon afterward, the state announced that it also had found another drug, 
warfarin, in certain lots of the herbal supplement.

Warfarin, also known by the brand name Coumadin, is an exceedingly 
powerful blood thinner -- so powerful, in fact, that it was first 
developed and sold as rat poison. Rats that eat it bleed to death.

The drug is used in patients prone to clotting, but cautiously. It 
interacts with many other drugs, and taking aspirin with it can kill 
some people who are particularly sensitive.

The California health department ultimately forced a recall of PC-SPES 
and another product called SPES, billed as an "immune system enhancing 
formula." The latter was found to contain undeclared alprazolam, better 
known as Xanax, a powerful tranquilizer that can cause numerous side 
effects.

In the end, the state found adulteration with some pharmaceutical agent 
in every BotanicLab product that it could test, including several 
discontinued ones, and a laboratory in Switzerland also found contamination.

*'Simply Too Sophisticated'
*

Robert Nagourney, a California cancer doctor who was originally a 
supporter of PC-SPES but grew wary as problems cropped up, conducted his 
own analytical tests, finally coming up with a definitive explanation 
for all the strange side effects the supplement had produced over the years.

His tests, on lots going back to 1996, showed the product had been 
spiked with low doses of DES and with an anti-inflammatory drug from the 
very beginning. The tests also suggested that after complaints about 
side effects began, someone repeatedly tweaked the PC-SPES formula, 
lowering the amount of DES, adding a less dangerous form of estrogen, 
and then eventually adding warfarin to the product in an attempt to 
counteract blood clotting from the estrogens.

"Obviously, some intelligent mind was orchestrating this thing," said 
Markham, one of the California lawyers suing BotanicLab and dozens of 
defendants accused of aiding the company. "This cocktail was simply too 
sophisticated."

Once the full scope of the product adulteration became known and the 
lawsuits began, BotanicLab shut down. Lawyers suing Sophie Chen have 
accused her of absconding with large sums, a charge she has denied.

Sophie Chen, John Chen, Xuhui Wang and the company itself were 
prosecuted in Orange County, Calif., accused of felonious conduct in 
selling dangerous products to the public.

But the state's case against them was circumstantial. A person close to 
the investigation, who would speak only on condition of anonymity 
because of the ongoing lawsuits, said the state had a relatively weak 
hand: no eyewitness testimony about who adulterated the products and no 
proof that BotanicLab had bought DES or other pharmaceuticals in bulk. 
At times BotanicLab has claimed that any product adulteration must have 
happened among bulk-herb suppliers in China. Moreover, this person said, 
the state got little help from the FDA and, at the time the criminal 
case was filed, had tests showing product adulteration only over a brief 
period.

In the end, the three individuals pleaded no contest to misdemeanor 
charges. All three said in court filings that they "had no preconceived 
design to injure other people."

Only the company, by then a defunct shell, pleaded no contest to a 
felony. The defendants were barred from the dietary supplement business 
in California and forced to pay nearly $500,000 in penalties.

In the telephone interview, Sophie Chen said that while she could not 
discuss details, she hoped that "truth and justice" would prevail and 
people would understand her side of the story. "In due time hopefully we 
will have more information out to the public, when my lawyer thinks it's 
time," Chen said. "I feel very badly because I would very much like to 
talk about it, but I can't."

*A Weak Regulator
*

The policies that allowed BotanicLab to operate for five years with 
little government supervision are rooted in decades of political 
struggle in Washington. The FDA has intermittently tried to tighten 
rules on dietary supplements, only to be fought to a standstill by 
industry lobbyists.

The biggest of these battles occurred in the early 1990s. After more 
than 30 deaths and numerous illnesses were attributed to a contaminated 
supplement called L-tryptophan, the FDA proposed a broad crackdown on 
supplement makers.

That effort backfired.

Prodded by industry publicity, huge numbers of Americans became 
convinced the government was about to take away their vitamins. "It was 
Armageddon as far as we were concerned," recalled Annette Dickinson, 
president of the Council for Responsible Nutrition, a Washington group 
that represents many supplement makers.

Moved by public protests, Congress passed the Dietary Supplement Health 
and Education Act of 1994. Supplement makers hailed the arrival of an 
era of "health freedom."

Drugs, the most stringently regulated category of consumer goods, must 
be proven safe and effective by their manufacturers before they can be 
put on the market. The 1994 law effectively prohibited the FDA from 
applying a similar standard to dietary supplements, even though they are 
often billed on the Internet and in store pamphlets as treatments for 
disease.

The FDA does have the power to ban some supplements if it can show "a 
significant or unreasonable risk of illness or injury." However, the 
burden of proof falls not on manufacturers to prove supplements are 
safe, but on the FDA to prove they're dangerous. Industry groups say 
that's a reasonable standard for a category of products that includes 
vitamins and minerals people have used for generations. Consumer groups 
contend that with 29,000 products on the market, the law effectively 
paralyzes the FDA.

"People cannot assume the FDA is minding the store, because it's not," 
said Marion Nestle, a nutritionist at New York University who has long 
followed the issue. "It can't. And they can't blame the FDA because 
Congress took away the ability of the FDA to do that."

The FDA's field force of inspectors, whose main job is to safeguard the 
food supply, in recent years conducted roughly 100 inspections a year to 
police the dietary supplement industry. The agency plans about 300 
inspections this year. Susan Walker, who has held the job of enforcing 
supplement rules at the FDA for the past two years, said she was 
committed to "full implementation" of the 1994 law, including stricter 
manufacturing rules. "We are moving diligently, and we want to get it 
right," she said.

Others, meanwhile, are assessing their roles. Stephen E. Straus, 
director of the National Center for Complementary and Alternative 
Medicine, a unit of the National Institutes of Health that funded 
PC-SPES research, said that in the late 1990s, scientists held the 
"somewhat naive" view that the label on an herbal product was an 
accurate description of what was in the bottle. His agency didn't 
require detailed ingredient testing of herbal products in studies it 
funded. It is revising that policy, yet finding adulterants in a complex 
herbal mixture remains difficult.

"This is a substantial analytic problem that remains a work in 
evolution," Straus said.

*Shattered Trust
*

In the civil suits claiming harm from BotanicLab products, numerous 
parties stand accused of aiding the company. Lawyers in the case have 
learned that Chen gave small amounts of company stock to collaborators 
she recruited at New York Medical College, where she held an unpaid 
adjunct faculty position, and they have asked whether that largesse 
tainted the scientists' judgment.

Several of the researchers in question have denied under oath that their 
judgment was altered, and the college itself has said it played little 
role in supervising Chen's work. She remains on the faculty there. "At 
no time has New York Medical College owned any interest in PC-SPES or 
its manufacturing or marketing entities, nor has it engaged in . . . 
distribution or marketing of the product," spokeswoman Donna E. Moriarty 
said in a written statement.

Milken's Prostate Cancer Foundation has also been sued. It has 
acknowledged awarding $150,000 in grants to Chen and another $500,000 to 
other researchers testing PC-SPES, but said these were small sums in a 
large research portfolio.

The victims' lawyers have turned up evidence that a Prostate Cancer 
Foundation executive traveled with Chen to China, that another published 
a paper with her, and that the group provided a venue for a conference 
on PC-SPES.

Leslie D. Michelson, chief executive of the foundation, said the group 
had done nothing wrong. "It's wonderful to look back with 20/20 
hindsight and say 'you should have known' " about the product 
adulteration, he said. "Nobody did know."

The lawsuits could take years. Meanwhile, some people who took the 
products said their illusions about natural remedies have been 
shattered. One cost of the PC-SPES debacle, some families said, was that 
faith in the herbs kept some people from undergoing more conventional 
medical treatment that might have saved their lives. That may be the 
case with Murray Berk, the Long Island garment buyer. By the time 
PC-SPES was pulled from the market he had been on it for years, and his 
daughter said doctors advised them that the DES in the supplement had 
rendered his cancer resistant to more conventional treatment. He died 
last year.

"Giving people prescription drugs without their knowledge is insane," 
said his daughter, Shelley Martin, who once sold herbal products but has 
grown wary of them. "I just cannot believe it. It's total fraud."

A California woman named Tatiana Palma was one of the people who took 
BotanicLab products and is now suing.

She said she thought taking natural products would be safe and might 
help with her rheumatoid arthritis. But she and her husband, Charles 
Pell, now believe the pills contained prescription drugs that worsened 
several of her medical problems and caused a blind spot in one eye.

Sitting in a Santa Monica restaurant, she recently gazed toward a sunset 
over the Pacific Ocean and said she had learned a hard lesson. "The only 
herbs I am ever going to trust again," she said, "are the ones I grow in 
my own back yard."

© 2004 The Washington Post Company






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