Charles Simone

Muhammed Majeed ofSabinsa

Joel Fuhrman

Sandra Byer-Lubin

Bonnie Arkus

Robert S. DiPaola MD

David A. August MD

NutRx Products

Christian LeFer

Joseph DiBartolomeo

Corrections or additions?

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

supplement market.

"We market nutritional products based on clinical studies

exclusively through physicians," says Christian LeFer, the

30-year-old founder. "This is nutritional, integrated medicine

that combines

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

cholesterol, and

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’

offices so

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

their patients."

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."

Top Of Page
Charles Simone

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."

Top Of Page
Muhammed Majeed ofSabinsa

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."

Top Of Page
Joel Fuhrman

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

NutRx board.

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."

Top Of Page
Sandra Byer-Lubin

"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."

Top Of Page
Bonnie Arkus

"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.

Top Of Page
Robert S. DiPaola MD

"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

is harmful."

"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

Medicine

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

trials.

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

Byer-Lubin.

"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

heart muscle.

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."

Top Of Page
David A. August MD

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.

Top Of Page
NutRx Products

Take a look at the list of NutRx products:

IpriMax, the newest, is said to not only build up the bone

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."

NutRx Elite, a multi-nutrient complex with antioxidants.

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

years.

IsoFiber is for those who need the right types of fiber to

normalize bowel function or lose weight, but who don’t eat enough

fruits and vegetables.

Arthriguard for arthritis and joint pain. This month the

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."

Prosterol. The natural compounds — saw palmetto berry

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.

Lipichol contains the clinical dose of three ingredients

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.

CardioVasc with CoQ10 with natural vitamin E and a host of

other antioxidants. If you have been diagnosed for — or are at risk

for — heart disease, this is what you should take, says DiBartolomeo.

Top Of Page
Christian LeFer

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

builders.

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

study.

"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."

Top Of Page
Joseph DiBartolomeo

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

disease.

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

Nutri/System.

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

never

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.

NutRx Natural Therapies, 11 Perrine Road,

Monmouth Junction 08502. Christian LeFer, CEO. 609-750-9200; fax,

609-750-9202. Home page: http://www.yourdoctorknows.com.


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