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This article by Barbara Fox was published in U.S. 1 Newspaper on
October 20, 1999. All rights reserved.
Can Grandma’s Remedy Be Profitable Medicine?
Eat right to stay well was what our grandmothers told
us, and now the
healthcare industry is giving credence to this advice. Nutriceutical
supplements — natural compounds that can have a significant impact on
the prevention and treatment of numerous health conditions — are no
longer being sold only by the health food hawkers. Supplements
containing herbs, vitamins, and minerals are being recommended by some
traditional physicians, and the National Institutes of Health is
encouraging research on such alternative therapies. Just this summer,
Unilever gave $1.25 million to the Cancer Institute of New Jersey so
that an eminent researcher can study how diet and nutrition might
prevent chronic disease.
That the supplement market has tripled in three years, growing from
$1.3 billion in 1997 to $3.9 billion last year, can be traced
to the Dietary Supplement Act of 1994. It liberated supplements from
Food and Drug Administration supervision unless, as happened with the
once-popular ephedra, an adverse effect has been found. Yet
traditional healthcare professionals still believe that supplements
need to be evaluated as carefully as regulated drugs, and they find
themselves in an uncomfortable position of knowing very little about
the supplements that their patients would like to take.
A dozen important producers of supplements are located in New Jersey.
One North Brunswick-based firm, NutRx Natural Therapies, aims to
capitalize on the
physicians’ need to find out about the supplements and also to exert
control over what their patients ingest. NutRx allows a consumer to
place an order only when the consumer’s doctor has been appropriately
informed. By leveraging its cunningly named web page,
http://www.yourdoctorknows.com, NutRx hopes to market to
consumers with the advice and consent of their physicians.
This four-year-old company has moved from New Brunswick to a 10,000
square foot facility on Perrine Road in North Brunswick. Aiming for $4
million in sales in 2000, NutRx plans to recruit, hire, and train up
to 20 sales representatives for the four-state area by the end of this
year. NutRx is also looking for new investors who will help the
company get to the next stage and — perhaps — for a buyout by a big
pharmaceutical company anxious for a quick entry into the burgeoning
"We market nutritional products based on clinical studies
exclusively through physicians," says Christian LeFer, the
30-year-old founder. "This is nutritional, integrated medicine
various therapeutic approaches to get the best results." He offers
nutriceutical supplements that he says have been
clinically proven to be effective for arthritis, atherosclerosis, high
benign prostate hypertrophy. His most popular product, and also the
newest, is for osteoporosis.
To differentiate between nutriceuticals and supplements: the term
"nutriceuticals" includes natural compounds or dietary supplements now
being used clinically to treat patients with diseases. A supplement,
an addition to one’s food intake to improve general health, can be
considered a neutriceutical when some clinical research has shown it
can improve health in a particular area, for instance, that vitamin E
improves cardiovascular health.
The price for most NutRx products is about $1 per day, which is
supposed to be less expensive than buying all the separate
ingredients. NutRx products are not available in drugstores or health
food stores; they can be ordered by the patient only if the patient’s
physician or health care provider has had a 30-minute education
session with a NutRx nutritionist, or the equivalent.
"No other nutriceutical out there is detailing physicians (educating
physicians) on research and correct dosages," says Joseph
DiBartolomeo, director of scientific affairs at NutRx (which uses the
German umlaut mark over the U). "NutRx wants to be in the physicians’
when they decide to move to natural therapy, we will be the company
they want to work with. We document the clinical studies and
double blind studies, and then they can prescribe these supplements to
Involving healthcare professionals in the distribution channel
prevents a consumer from purchasing supplements without knowing their
exact ingredients or what dosage is necessary for the particular
problem, says DiBartolomeo: "There is no way for the consumer to know
the correct dose."
Some of the well-known brands have such a tiny dose of the needed
ingredient that the consumer isn’t helped at all, agrees Charles
Simone, founder of Simone Cancer and Immunology Center on Franklin
Corner Road and author of "Cancer and Nutrition," published in 1995.
Nutriceutical companies can let doses go awry in other ways, such as
using the wrong ingredients or poor quality ingredients. One
researcher analyzed different brands claiming to contain the same
amount of ginseng and found the amount of active ingredient in each
pill varied by a factor of 10, and some contained none at all.
But DiBartolomeo claims to scrupulously follow the formulas that he
says have been proven effective by research. "We use established
sources and manufacturers that are well recognized in the field, so we
know we have quality control built in from raw ingredients to
manufacture," says DiBartolomeo. For instance, the new osteoporosis
product, IpriMax, is made by Garden State Nutritionals in North
Jersey. Other supplements are made at Vitaquest International, which
LeFer terms "the premier manufacturing facility in the country."
A leading ingredient supplier, Muhammed Majeed of Sabinsa (which has a
Piscataway headquarters and a laboratory on Deer Park Drive,)
testifies that NutRx "is a very quality conscious company."
Orders are shipped overnight, followed by educational newsletters to
the patient and consultations with the practitioner about the
patient’s response. "NutRx does their homework and puts out
vitamins that may be a little more expensive but are worth the price,"
says Joel Fuhrman, a Hillsborough-based physician who sits on the
Whether or not NutRx is using the right formulas and the right
ingredients really doesn’t matter to those who oppose using
supplements at all. The crux of the problem is the claim that
supplements are effective but are not "drugs." Yet most doctors
believe that anything that affects the body is indeed a drug, and an
unregulated, unknown drug at that.
But as a result of the 1994 act instigated by Senator Orrin G. Hatch,
the supplement companies are required to submit only limited safety
and efficacy data to the FDA. "If the claim is not on the label, we do
not have the authority to take any action," says a spokesperson from
the FDA’s Center for Food Safety and Applied Nutrition. "If it is a
new dietary ingredient they have to let us know 75 days in advance."
"We really don’t know what supplements and herbals will do in high
doses in the long term," says Sandra Byer-Lubin, a registered
dietitian and nutritionist with a practice in West Windsor and Kendall
Park. She cites the example of beta carotene. "Everyone was taking it
in high doses to prevent cancer, and then it was shown that it
increased the risk for lung cancer."
"People in the healthcare field are skeptical about how little is
known about the interaction between herbs and drugs," says Bonnie
Arkus, founder of the Women’s Heart Foundation, founded seven years
ago to improve the survival and quality of life for women with heart
disease. Anesthesiologists, she says, have advised against taking any
herbals for two to three weeks before scheduled surgery, because such
herbals as St. John’s Wort and ginseng intensify the effect of
anesthesia. Also she warns against women taking herbals while they are
pregnant or breast feeding.
"We can learn a lot from herbal therapies," says Robert S. DiPaola, a
medical oncologist at the Cancer Institute of New Jersey and the
clinical director of the Institute’s Gallo Prostate Center. "And they
can have good effects. But it is only a logical argument that if these
herbs have drug-like effects, they can also have side effects."
DiPaola thinks that most physicians will not have time to sort out the
clinical studies offered by NutRx because they are so accustomed to
depending on the rigors of the FDA clinical trial process. To compare
FDA-regulated studies and any other kind of studies is like comparing
apples and oranges, he says.
Even the marketing cannot be regulated. "Unfortunately the public is
often deceived by efforts at marketing," says DiPaola. "There is no
requirement by those who market to reveal what they might not want to
reveal." Labels do have to say that the substance was not evaluated by
the FDA and are not allowed to refer to the disease directly. A
compound designed to affect prostate cancer, for instance, can refer
only to "prostate health."
To illustrate his deep concern over how supplements may be misused,
DiPaola cites his own research on the effect of a PC-SPES, an herbal
dietary supplement purported to help prostate cancer. In a paper
published in the New England Journal of Medicine DiPaola reported that
PC-SPES was estrogenic and reduced blood testosterone, which caused
male impotence and breast tenderness. "The safety of nutritional
supplements with substantial estrogenic activity needs to be
evaluated," says DiPaola.
An editorial in the same issue of the New England Journal of Medicine
bemoaned the fact that some men taking PC-SPES were also getting
estrogen doses from their physicians, thus effectively doubling that
dose. "Anyone can walk into a health food store and unwittingly buy
PC-SPES with unknown amounts of estrogenic activity, plaintain laced
with digitalis, or Indian herbs contaminated with heavy metals. The
FDA can intervene only after the fact, when it is shown that a product
"It is time for the scientific community to stop giving alternative
medicine a free ride," says the editorial. "There cannot be two kinds
of medicine — conventional and alternative. There is only medicine
that has been adequately tested and medicine that has not, medicine
that works and medicine that may or may not work. Alternative
treatment should be subjected to scientific testing no less rigorous
than that required for conventional treatments."
The editorial writers acknowledge that the Office of Alternative
in the National Institutes of Health funded more than 28 studies, but
complain that as of 1998, only nine final reports resulted in
published papers. Five were in relatively unknown journals and the
other four relied on anecdotal accounts, not controlled clinical
At a national meeting held last June, the protagonists — doctors,
pharmacists, government regulators, researchers, and manufacturers —
could only agree to disagree on how to ensure that supplements are
safe and effective.
"I tell patients there is nothing really established except for the
basic things such as calcium and vitamins C and E," says nutritionist
"More and more supplements are being used by traditional doctors, and
the weight of evidence based on clinical trials is accumulating,"
counters DiBartolomeo. "Vitamin E is a good example. It is hard for a
cardiologist not to recommend small amounts of vitamin E, but 10 years
ago it was unheard of." The time will come, he promises when a
compound called CoQ10 will enjoy a similar status. It seems that
taking a "statin" or cholesterol-lowering drug blocks production of
CoQ10, a compound naturally occurring in the body that strengthens the
Many cardiologists are not familiar with this CoQ10, but if one of
their patients contacts NutRx about buying it NutRx will contact the
doctor. If the doctor agrees, NutRx will send a representative to
present the clinical studies so the doctor can make his or her own
decision. Voluminous numbers of these studies are also available on
the website. "It puts the doctor back in charge," says DiBartolomeo.
"We combine CoQ10 in the proper dose, minimum 30 milligrams, with
Vitamin C, natural E, and grape extract, which is an antioxidant."
Dietary antioxidants are another good example of how a natural
compound first used in alternative medicine can make its way into
integrative or complementary medicine and then to traditional methods.
Antioxidants found in such foods as tea and tomatoes are said to guard
against harmful effects of "free radicals" found in high fat diets
rich in hydrogenated or partially hydrogenated oils. David A. August,
acting chief of surgical oncology at the Cancer Institute of New
Jersey, is studying antioxidants to see whether there is a link to
preventing disease. Preliminary research indicates that drinking two
or three cups of green tea might help suppress chemicals in the body
that may play a role in promoting colorectal cancer.
Take a look at the list of NutRx products:
but also to prevent bone loss, especially important for women who,
perhaps due to their dietary habits — frequent low calorie diets and
high protein diets — have been deficient in bone minerals for years.
In addition to its main ingredient, a plant estrogen named
ipriflavone that works to stimulate bone density, IpriMax contains
calcium (the building block for bone mass), and vitamin D (which helps
to absorb the calcium), plus several other bone minerals. Results from
double blind clinical trials were released in July. Says DiBartolomeo:
"We are the only ones that have the ipriflavone together with calcium
and vitamin D, in the dosages studied."
Eating five fruits and vegetables a day in your 40s doesn’t resolve
the multiple issues of deficiency over the years, say DiBartolomeo.
You need more than five a day to get the antioxidants to prevent
cancer, and these supplements are supposed to make up for the misspent
normalize bowel function or lose weight, but who don’t eat enough
fruits and vegetables.
Arthritis Foundation recommended glucosamin sulfate, thus supporting
the use of complementary therapies, says DiBartolomeo. "This is the
type of thing we expect to see happening in the coming year."
extract (SPB), pygeum, pumpkin seed concentrate, and isoflavones –in
Prosterol help to relieve the symptoms related to an enlarged prostate
(benign prostate hypertrophy or BPH). BPH causes urinary problems but
does not necessarily lead to prostate cancer. Prosterol also has
lycopene, and diets high in lycopene have been linked with low
incidence of prostate cancer but the combination of ingredients in
Prosterol were primarily developed only for relieving BPH symptoms.
shown in clinical studies, with human studies, to lower cholesterol:
red yeast rice extract, niacin in the form of hexaniacinate, and a
natural form of vitamin E, tocotrienol. "No other products combines
all three," says DiBartolomeo. He recommends this for those with
border-level elevated lipids who are not taking prescription drugs.
other antioxidants. If you have been diagnosed for — or are at risk
for — heart disease, this is what you should take, says DiBartolomeo.
LeFer’s interest in neutriceuticals developed from a relative’s
experience with curing heart disease. His father, a native of Brittany
in France, was an entrepreneur in the exotic car business, and his
American-born mother worked for various French companies, including
Peugeot. For five years after high school LeFer did sales and
marketing in such areas as automobiles and home goods, then earned an
associate’s degree and graduated from Rutgers in 1997 with a major in
history and political science.
While at Rutgers LeFer started doing research on going into his own
business and noticed that the interest in nutrition and fitness was
blossoming, that vitamin stores were popping up everywhere, and that
scientists were starting to do studies on supplements for body
What clinched his decision to go into neutriceuticals was his uncle’s
dramatic recovery from severe cardiovascular illness. "Ten years after
my uncle’s first quadruple bypass, he was diagnosed with severe
blockage in the same four arteries, and was given a year to live,"
says LeFer. The uncle was put on an aggressive six-month regimen of
low fat food and neutriceuticals: CoQ10, ginko, grape seed extract,
and some minimal exercise. "After six months his doctors found that
most or all of the indicators of his condition had reversed. That was
seven years ago."
LeFer was 25, and he began attending industry events, forging
relationships with researchers, and physicians. He credits Brian
Beck of the New Brunswick Economic Development Authority with
providing some entrepreneurial advice. He started the company with
leftover money from a student loan and a credit card, first in a home
office, then in shared space at 120 Jersey Avenue. He is single and is
very involved at Princeton Alliance Church, where he co-chairs a Bible
"There is no disconnect between religion and business for me," says
LeFer. "My enthusiasm and care for others is reflected in my church
efforts and my business. I believe we are genuinely helping others."
DiBartolomeo, who joined the firm last year, based his career in
food-related industries on his mother’s tutelage; she was diagnosed
with a heart condition in her late 20s and adopted a very healthy diet
of natural fruits and vegetables. "She taught us that what you eat has
an effect on how you feel," says DiBartolomeo. That fit right in with
the Nathan Pritikin diet in the late ’70s and the discovery by Dean
Ornish that diet and lifestyle changes could indeed reverse heart
An alumnus of Rutgers University, Class of 1973, DiBartolomeo has a
master’s in science from Rutgers and a PhD in health education,
specializing in nutrition, from the University of Maryland.
He was a nutritional expert for various health systems, including
Temple Hospital, and was vice president for scientific affairs of
While at Nutri/System he went through what amounts to a "trial by
fire," a controversy over the compound ephedra. This incident
illustrates the vulnerability of any company that puts anything —
supplements, neutriceuticals, or drugs — on the market.
Nutri/System’s appetite reducing product was called Herbal PhenFen, a
name intended to sound similar to the then wildly popular drug duo,
phentermine and fenfluramine. (Phen-Fen, as it was popularly known,
was an untested combination that, because it may have adversely
affected heart valves, is now the cause of class action lawsuits
against the companies that marketed it, including American Home
Products with its Redux brand.)
But the sound-alike NutriSystem product, developed for those who were
not clinically obese, contained neither phentermine or fenfluramine.
What it did contain was two herbal compounds, ephedra and St. John’s
Wort. Ephedra has been linked by the FDA to at least several deaths
and is now being regulated in 14 states, says Arkus.
In an article about Herbal Phen-Fen DiBartolomeo was quoted as saying
the diet center didn’t know exactly how the herbs work together, just
that they do. "We believe from using the products in our centers that
there is a synergistic action with St. John’s Wort and ephedra, when
you put them together, that works to suppress appetite."
Traditionalists might point to the danger of selling a combination
without knowing how it works. But DiBartolomeo notes that drugs —
which are "hundreds of times more concentrated than natural compounds"
— are also commonly used in combinations that have not been subjected
to clinical research. "Doctors put patients on combinations of high
blood pressure drugs for years and years, yet the combinations have
been studied," he says. "The FDA ought to be working on the more
serious issues of combinations of drugs rather than on the natural
elements used in food."
Anyway, says DiBartolomeo, a number of companies are currently
marketing similar products that combine St John’s Wort with some kind
of stimulant, like ephedrin, to control the appetite. (It should be
noted that no NutRx product contains ephedrin, and that this company
has no plans to even do research on an appetite reduction product.)
Nutriceuticals can’t effect change, author Simone
insists, unless lifestyle changes — in nutrition, stress, exercise,
etc. — are made as well. "Don’t think you can
take a pill and get away with murder," he cautions.
DiPaola, the researcher who raised concerns about men’s use of
PC-SPES, cautions against comparing the studies cited by alternative
medicine practitioners with the stringent clinical trials required by
the FDA. "We can learn a lot from herbal therapies," he says. "They
can have good effects, but because they contain chemicals that act as
drugs they can also have side effects. As physicians and researchers
we should study them so we can make more use of them."
If physicians know what side effects to look for they can play an
active role. "Seek out what patients are on and keep them safe," says
DiPaola. "Educate patients, because patients will often be doing this
anyway. Be proactive."
"A good physician or scientist can help sort out what are the good and
bad studies. In general the public may not be able to tell the
difference," says DiPaola.
That is exactly the position NutRx holds with its business model and
its website yourdoctorknows.com: Physicians should have the final say.
Monmouth Junction 08502. Christian LeFer, CEO. 609-750-9200; fax,
609-750-9202. Home page: http://www.yourdoctorknows.com.
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