022 3036

COMPLAINT

The Federal Trade Commission, having reason to believe that Unither Pharma, Inc., a corporation, and United Therapeutics Corporation, a corporation, have violated the provisions of the Federal Trade Commission Act, and it appearing to the Commission that this proceeding is in the public interest, alleges:

1. a. Respondent Unither Pharma, Inc. ("Unither Pharma") is a Delaware corporation with its principal office or place of business at 1110 Spring St., Silver Spring, Maryland 20910. Unither Pharma is a wholly owned subsidiary of Unither Pharmaceuticals, Inc., which is wholly owned by respondent United Therapeutics Corporation. Unither Pharma markets and sells an L-arginine-based dietary supplement and a purported medical food under the HeartBar brand name. This dietary supplement purportedly treats or prevents cardiovascular disease and/or improves endurance.

b. Respondent United Therapeutics Corporation ("United Therapeutics") is a Delaware corporation with its principal office or place of business at 1110 Spring St., Silver Spring, Maryland 20910. United Therapeutics participated in the advertising claims challenged herein, including the creation and dissemination of Exhibits H through J.

2. Respondents have advertised, offered for sale, sold and distributed products to the public, including HeartBar, HeartBar Plus, and HeartBar Sport. These products are "foods" and/or "drugs" within the meaning of Sections 12 and 15 of the Federal Trade Commission Act.

3. The acts and practices of respondents alleged in this complaint have been in or affecting commerce, as "commerce" is defined in Section 4 of the Federal Trade Commission Act.

4 Respondents have disseminated or have caused to be disseminated advertisements for HeartBar and HeartBar Plus (collectively "HeartBar") and HeartBar Sport, including but not necessarily limited to the attached Exhibits A through J. Since at least 1999, advertisements and promotions have appeared on the cookepharma.com and unither.com websites, on product packaging, and/or in print media, such as Reader's Digest, Modern Maturity, Prevention, The San Francisco Chronicle, The Chicago Sun-Times, The Detroit Free Press, The Cleveland Plain Dealer, The Miami Herald, and newspaper inserts published by News America Marketing FSI, Inc. HeartBar products are sold in two forms, an edible bar and a powder, which is mixed with water. The bars have sold for approximately $2 each. According to the product labels, HeartBar and HeartBar Sport contain, among other ingredients, 3 to 6 grams of L-Arginine, soy isoflavones extract, Vitamins A, B-6, B-12, C and E, niacin, folate, iron, and calcium. The advertisements for HeartBar contain the following statements, among others:

Print Advertising:

A. Today people with heart disease are discovering that taking two HeartBars a day is bringing welcome relief from heart disease symptoms such as … leg pain - usually within the first two weeks.

One HeartBar a day thereafter may be sufficient to maintain results. …

Studies show that taking two HeartBars a day …

* * * *

Reduce[s] painful symptoms such as angina and leg pain

* * * *

(Ex. A) (Ex. A is a print advertisement for HeartBar).

B. Here's what HeartBar can do…

Improve … heart health

* * * *

Reduce painful symptoms such as … leg pain

* * * *

(Ex. B) (Ex. B is a print advertisement for HeartBar).

Internet Advertising:

C. HeartBar® Plus contains 6 grams of arginine per serving, and it has been shown in clinical trials to be effective in ... decreasing angina ... in patients with coronary artery disease. In addition, HeartBar® Plus may be of benefit to selected at-risk population of developing cardiovascular disease.

(Ex. C at 1) (Ex. C consists of webpages from the cookepharma.com website dated March 26, 2002).

D. Eating two HeartBars a day …:

• Reduces painful symptoms of heart disease such as … leg pain

* * * *

• Helps improve ability to exercise without pain, discomfort…

* * * *

Results are usually experienced within the first two weeks. After two weeks, one HeartBar® may be sufficient to maintain results.

(Ex. D at 1) (Ex. D consists of webpages from the cookepharma.com website dated August 20, 2001).

E. …Not to be mistaken for health bar look-alikes, new HeartBar® contains a scientifically proven ingredient to reduce the pain … associated with vascular disease … .

* * * *

Fifteen years of scientific research at major institutions reveal that in certain patients the dietary use of the nutritional ingredients in HeartBar®:

• Helps reverse the effects of high cholesterol, smoking, diabetes, and estrogen deficiency on the heart

* * * *

(Ex. C at 5-6) (Ex. C consists of webpages from the cookepharma.com website dated March 26, 2002).

F. How does HeartBar® Work? … The active ingredients in HeartBar® have been clinically proven, in properly selected patients, to … increase pain-free exercise performance.

(Ex. C at 7) (Ex. C consists of webpages from the cookepharma.com website dated March 26, 2002).

G. How many HeartBars should a consumer eat a day to receive all of the heart and vascular benefits?

Clinical research shows that, for best results, … significant improvement (66%) in pain free walking distance … [is] achieved by eating two bars a day.

(Ex. D at 2) (Ex. D consists of webpages from the cookepharma.com website dated August 20, 2001).

H. HeartBar Sport is a line of L-arginine dietary supplements developed from our experience with HeartBar Plus. HeartBar Sport contains 3 grams of arginine per serving, and it has been shown in clinical trials to improve endurance and energy.

(Ex. C at 3) (Ex. C consists of webpages from the cookepharma.com website dated March 26, 2002).

I. Who are HeartBar® products for?

* * * *

HeartBar® Sport, the dietary supplement, is intended for older adults or at-risk individuals who wish to maintain good cardiovascular health, as well as benefit from increased energy and endurance.

(Ex. C at 14-15) (Exhibit F consists of webpages from the cookepharma.com website dated March 26, 2002).

J. The following testimonials from doctors have appeared on the cookepharma.com website:

1. Doctor's Corner

____________________________________

John P. Cooke
Vascular Medicine
Stanford University School of Medicine
Stanford, CA

A Nutritional Approach to a Healthy Endothelium:Case

Histories

I have been studying the endothelium for the better part of two decades, first at Mayo where I was trained, then as an Assistant Professor at Harvard, and now as Associate Professor and Director of the NIH-funded Vascular Medicine Program at Stanford. …

The HeartBar® has now been tested in rigorous, double-blind, placebo-controlled trials and has been shown to improve exercise tolerance and reduce pain in patients with coronary and peripheral arterial disease. Although these clinical trials are very gratifying, what I find even more satisfying are the positive results that I have observed in my own clinic. Here are a few representative anecdotes:

* * * *

A 78 y/o male with intermittent claudication

L. M. is a vigorous 78 year old man who looks younger than his stated age. As an alpine biologist, one of his classes each year involved a month of hiking over the heights of Yosemite and King's Canyon. Now, in retirement he is still an outdoorsman, and enjoys outdoor activities with his son.
For the last few years though, he had noticed cramping in his legs after walking up a hill. The discomfort would subside if he stood still for a moment, and then he could go on. But about two years ago, the cramping became a real disability for him. He was tightening up after walking a half-mile, and he could only go that far if he walked slowly. The great outdoors was getting farther away for LM.

He came to my Vascular Medicine clinic at Stanford in the spring of 1999. I prescribed Trental 400 tid. He returned to me 6 weeks later with little improvement. At that point I stopped the Trental and introduced him to the HeartBar. LM began taking two bars daily. It wasn't long before he noticed an improvement, and over time, he continued to improve. At the time of this writing, LM is able to walk faster, without pain, and considers himself unlimited. He is even able to jog a quarter of a mile before he needs to slow down. He's back to the hills, and enjoying the outdoors again with his son.

I hope that you found these anecdotes interesting. I welcome you to send in your own anecdotes regarding your experience with this nutritional therapy.

With warmest regards,
John P. Cooke, MD Ph.D.
Associate Professor and Director
Section of Vascular Medicine
Stanford University School of Medicine

____________________________________

2. Doctor's Corner

____________________________________

Alan S. Bailer
Cardiovascular Diseases
1330 Cottman Ave.
Philadelphia, PA 19111

Patient Success Story

My 77 year old father had a triple coronary artery bypass grafting procedure in 1984. …

* * * *

I am convinced that, without the HeartBars, my father would have had to undergo another revascularization. Thank you, Cooke Pharma, for this wonderful product.

____________________________________

3. Doctor's Corner

____________________________________

Marcus S. Kryger
Box 280
Forsyth, MO 65653

PVD Patient Success Stories

• 82 Year old white female with ischemic cardiomyopathy and severe peripheral vascular disease by IMEX scan. Unable to walk 1 block due to leg pain and dyspnea. She was scheduled for femoral artery bypass, but started on HeartBar. Three months later, without surgery or other medical changes, she was walking 2 miles daily and continues to do so, without symptoms, 15 months later.

* * * *

• 86 Year old white male with CHF due to ischemic cardiomyopathy and severe leg pain on walking over 50 feet. Started on HeartBar BID, no other changes in medical regime. A month later he repaired his roof by himself without any symptoms. He felt well for 4 months then stopped HeartBar. He rapidly became more dyspneic; restarted HeartBar BID with prompt improvement and went deer hunting this past fall.

____________________________________

4. Doctor's Corner

____________________________________

Peter Gray
90 South St.
Glens Falls, NY 12801

Great Results--Reducing Angina Episodes, Claudication…

Great results regarding:

* * * *

• Reducing claudication.

I'm now using it with my father for claudication with excellent results.

____________________________________

(Ex. C at 8-13) (Ex. C consists of webpages from the cookepharma.com website dated March 26, 2002).

K. The following testimonials from HeartBar customers have appeared on the cookepharma.com website:

1. Mary R. Gompf from OH

"It was just like my Doctor said. After only 2 weeks of taking the HeartBar, I noticed a dramatic reduction in my … leg pain. …Thank you."

2. Mr. Barry Dangler from FL

"…My Cardiologist has taken me off of Imdur for my angina pain now that I'm taking the HeartBar. I feel great."

3. Ms. Betty Burke from CA

"I had severe burning pain in my left leg when I ran up hills. My AB Index, done by Stanford Research, in my left leg was only .5. I read on the Internet that a .4 Index might require amputation. After 2 weeks taking the HeartBar, the burning pain is gone! I can run with no pain. I also don't have any leg pain when playing tennis. I was seen by a vascular surgeon who proclaimed that I had excellent circulation in both legs. HeartBar has really changed my life!"

4. Mr. Sam Roska from CA

"I have atherosclerosis in both legs. After 2 angioplasties on my legs, my doctor put me on HeartBar. Further angioplasty presented a 20% risk of amputation. I had been able to walk only up to about 3 minutes before debilitating leg pain forced me to stop. After about a month on the HeartBar, I was able to walk 10 minutes with no pain! I now have much less pain than before."

5. Thomas Overbeek from MI

"I have had leg pains for about 10 years. The pain in my left leg became especially bad in the last 6 months. I could barely walk from the bedroom to the bathroom. I couldn't stand up without pain. Because of my worsening condition, I was scheduled for bypass surgery in my leg. My doctor told me my pain would remain, however. But, after 2 weeks taking the HeartBar, the pain in my leg disappeared. It was unbelievable! As scheduled, I went into see my surgeon the day before my surgery; he cancelled the surgery. I haven't felt this good in 10 years. I can walk and climb stairs with no pain now, and can stand for half an hour. …"

6. Al White from MI

"I am almost an Octogenarian (in 6 months)…. I have not had to use my Nitro-Stat pills since I started using HeartBars--not a single one. I got my Doctor's OK first to use the HeartBars."

(Ex. C at 16-18) (Exhibit F consists of webpages from the cookepharma.com website dated March 26, 2002).

Packaging:

L. Front panel:

HeartBar

Plus

6g L-Arginine per Bar

Clinically Proven Results

* * * *

Reduces angina and leg pain

(Ex. C at 2) (Ex. C consists of webpages from the cookepharma.com website dated March 26, 2002; page 2 depicts packaging for HeartBar Plus).

M. Front panel:

HeartBar

* * * *

Recommended by Doctors for Daily Use

* * * *

• Helps Reduce… Leg Pain

* * * *

Back panel:

If you have heart disease, take two HeartBars

a day to feel a difference within two weeks.

Eating two HeartBars a day helps … with the following results:

• Reduces painful symptoms of heart disease such as … leg pain

****

• Helps improve ability to exercise without pain, discomfort …

****

(Ex. E at 1-2; citation omitted) (Ex. E is a copy of the packaging for HeartBar).

N. Front Panel:

HeartBar

Sport

Dietary Supplement

3g L-Arginine per Serving

Clinically Proven Results

Improves endurance… and energy[]

(Ex. F; citation omitted) (Ex. F is a copy of the front of the packaging for HeartBar Sport from 2002).

Other Promotions:

O. Is HeartBar® Right for You?

* * * *

If you are elderly, you might want to consider that as we age, our need for arginine in the diet increases. Eaten in the right amount, arginine can help prevent a variety of age-related vascular problems, including "hardening of the arteries" and plaque formation, and prevent or reverse the symptoms associated with them. …

(Ex. G at 2) (Ex. G is an excerpt from the jewel case insert for The Heart of the Classics musical Compact Disc given to HeartBar distributors).

P. …[E]ating HeartBar® products … can improve your aerobic performance. For these reasons, even those who are not experiencing heart disease or age-related symptoms choose to make HeartBar® part of their daily regimen.

Clinical Research Confirms that HeartBar® …

* * * *

Relieves painful symptoms such as angina and leg pain.

* * * *

(Ex. G at 3) (Ex. G is an excerpt from the jewel case insert for The Heart of the Classics musical Compact Disc given to HeartBar distributors).

Q. See Results in Two Weeks!

In clinical studies, after only two weeks of eating two HeartBars® daily, patients showed significant improvement in angina scores ....^[] In patients suffering from PAD (peripheral artery disease), HeartBar® was shown to significantly improve the ability to walk pain free.^[] After the initial two weeks, one HeartBar® a day may be sufficient to maintain these results.

* * * *

70% reduction in angina pain

66% increase in ability to exercise

(Ex. G at 4; citations omitted) (Ex. G is an excerpt from the jewel case insert for The Heart of the Classics musical Compact Disc given to HeartBar distributors).

 

R. "In my experience, recommending Heart Bar has helped to stop heart disease in my patients."

Joe Predergast, M.D.

Diabetes Specialist

(Ex. H. at 2; Ex. K is an excerpt from the 2001 United Therapeutics Corporation Annual Report).

S. HeartBar

… Clinical studies conducted by Cooke Pharma have demonstrated the ability of the HeartBar to reduce painful symptoms associated with cardiovascular diseases …. Randomized, double-blinded clinical studies published in medical journals and presented at the 2000 American Heart Association meeting have shown that the HeartBar works. …

(Ex. I. at 2; Ex. I is an excerpt from the 2000 United Therapeutics Corporation Annual Report).

T. United Therapeutics Acquiring Cooke Pharma, Expanding into Angina and Coronary Artery Disease

Silver Spring, MD and Belmont, CA, December 18, 2000 -

* * * *

…Clinical studies conducted by Cooke Pharma have demonstrated convincingly the ability of the HeartBar to reduce painful symptoms of cardiovascular disease…. …

(Ex. J at 1; Ex. J is a December 18, 2000, press release from the unitedtherapeutics.com website).