II. MY FINDINGS ABOUT YOUR DRUGS:

A. Your Drugs Do Not Work

Based on the facts discussed above, I suspected that many of the PLS patients who had taken your drugs would eventually realize that your drugs do not work--that their PLS had progressed in spite of the fact that they were using your drugs. But it would probably take quite a while for this to become obvious, since PLS can progress very slowly.

Some of these patients would discontinue taking your drugs. They would do so in spite of your warnings that shortly after discontinuing your drugs, patients would deteriorate down to the level that they would have been had they never tried your drugs in the first place. ( Enclosure 12, letter to William Figueroa, M.D.; and Letter to the Editor of the PLS Newsletter, December, 1994, by Helmut F. Prahl.)

In 1998, I tested my theory by calling several PLS patients who started taking your drugs a few years before that. Three of the five patients that I called had praised your drugs in letters to the editor that were published in the PLS Newsletter. Certainly, if your drugs really work, at least these three should still praise your drugs.

Of those five PLS patients, four of them (80%) told me that they no longer took your drugs. They all felt that your drugs had not helped them--although it took quite a while to realize this. None of them noticed any negative effects from discontinuing your drugs.

According to the March, 1994 issue of the PLS Newsletter, "there are twelve PLS-people currently taking C-3036 and eight who started and did not continue." That's 40% who had decided that C-3036 did not work. There was no follow-up information on the twelve people who still took your drug in 1994. Are they still taking your drug currently?

Joe Alberstadt, the past publisher of Synapse, polled his subscribers about their lives with PLS. One of his questions inquired about medications and supplements taken to relive the symptoms of PLS.

Seven (7) of the Synapse subscribers reported having taken your C-3036. Five (5) of them (71%) have quit.

Your drugs do not work. Your claim that they are "essentially 100% efficacious" (enclosure 1: letter, page 1.) appears to be completely wrong. Do you exclude from your statistics everyone who took your drugs and discovered that they did not work?

Is it your position that the people who had quit taking your drugs were mistaken in their belief that their PLS had progressed while they were taking your drugs?  Is this your position even for the people who had written glowing testimonials about your drug to the PLS Newsletter, but ultimately realized your drugs to be worthless?

Two of the patients who praised your drugs in the PLS Newsletter stated that you had asked them to write the letters. Would a legitimate research scientist do this--or a salesman?

One patient told you that she had informed her neurologist and primary care doctor about you and your drug. You became irate. You told her that you were cutting off her drug supply. Only after she promised to never tell another physician did you relent and agree to continue to supply her with your drug.

Why were you trying to hide from the medical profession?

You stated that if the effect of a drug

This effect certainly doesn't hit me in the face. Your "cushioning material" doesn't work and should not even be on the black-market.

B. What Is The Difference Between C-3036 and C-3236?

Bottles of C-3036 list four active ingredients--"triacontanol, dotriacontanol, tetratriacontanol, and hexatriacontanol". ( Enclosure 10: copies of photos of a bottle of "C-3036".)

You told me back in 1997 that the name "C-3036" is a shorthand expression for the mixture of two substances--C-30 and C-36. These substances are ultra-long chain alcohols. The numbers indicate the number of carbon atoms in each substance. Thus C-30 has 30 carbon atoms and C-36 has 36.

A list of the substances from C-24 through C-36 follows:

C-24 Tetracosanol,

C-26 Hexacosanol,

C-28 Octacosanol,

C-30 Triacontanol,

C-32 Dotriacontanol,

C-34 Tetratriacontanol, and

C-36 Hexatriacontanol.

(See the U.S. Patent & Trademark Office, Patent Full Text and Image Database, available at http://164.195.100.11/netahtml/search-bool.html(search for "5,952,393" in the field "patent number" for "all years". Then see the section entitled "Detailed description of the Invention".)

"C-3036" should be a mixture of triacontanol (C-30) and hexatriacontanol (C-36). But your bottle of "C-3036" also lists "dotriacontanol" (C-32) and "tetratriacontanol" (C-34) as ingredients. Your "C-3036" should more accurately be called "C-30323436". Of course, it could also be called C-3236 without changing its composition.

C. Your "Octacosanol" is Mass-marketed For Various Alleged Purposes

I found that some of your drug's ingredients are contained in several nutritional supplements that are available over the counter in drug stores, health food stores, and supermarkets. I know that you are well aware of this.

You licensed Twinlabs Corporation to market your octacosanol as a dietary supplement, according to the Life Extension Foundation. (See http://www.lef.org/newshop/items/item00104.html.)

Your "Octacosanol" contains "Octacosanol 8000 mcg, Triacontanol 11900mcg, Hexacosanol 533 mcg, (and) Tetracosanol 3080 mcg." (See http://www.twinlab.com/productinfo.htmland search "Sports Nutrition" for "Octacosanol".) (April, 2001 UPDATE: The previous link has changed. Go to http://www.twinlab.com. Click "product information" on the top of the page. Then enter "octacosanol" in the second search window, and click "submit query".)

Global Nutrition charges $7.99 for 60 of your Twinlabs "Octacosanol" capsules, plus $5.00 for shipping and handling per order. ( http://www.global-nutrition.com/b/twinlab.htm)

In the nutritional supplement trade, formulations like your "Octacosanol" are called "policosanol", since they contain a mixture of many ultra-long chain alcohols. (See http://www.moocalcium.com/oocta.htm#general and http://www.gvisourcing.com/pharmaceuticals/ppg/specs.html.) (April, 2001 UPDATE: The previous link has changed. Go to http://www.gvisourcing.com. Once it completely loads, click "pharmaceuticals". Then click "PPG".)

Octacosanol/policosanol comes from the waxy outer covering of numerous plants. Commercially, wheat, spinach, sugar cane, alfalfa and other plants, as well as beeswax can be used to obtain octacosanol. Manufacturers process these materials by adding a solvent to extract the policosanol. (For information on other inexpensive sources of policosanol, as well as how it is manufactured, see Garuda International, Inc. at http://www.moocalcium.com/oocta.htm#general; Kampoyaki Nutriceulicals (which makes a policosanol powder obtained from wheat germ and wheat germ oil), at http://www.kampoyaki.com/general//nutrice/o000010.html; GVI Sourcing, (the source of a Cuban policosanol product, called PPG-5,or Ateromixol), at http://www.gvisourcing.com/pharmaceuticals/ppg/specs.html (April, 2001 UPDATE: The previous link has changed. Go to http://www.gvisourcing.com. Once it completely loads, click "pharmaceuticals". Then click "PPG".); Nutri-Mart, (lists four companies that market five products containing policosanol.), at http://www.nutrimart.com/exe-bin/queries/product.idc?Description=octacosanol .);Vitamins.com at ( http://www.vitamins.com/store/products/0/2810.html); Nutrilabs International, at http://www.csos.com/nutrilabs.);and Doctor's Nutrition at http://www.doctorsnutrition.com/cosanall.htm.)

D. Do Your Drugs Actually Cure Everything That You Have Claimed?

I am very suspicious about a drug that its seller claims can treat many different diseases. You claimed that it could be used for "ALS, multiple sclerosis, neuropathies, Parkinson's disease, cerebral palsy, stroke, etc."--six (6) different neurological diseases (excluding "etc")--each one with no cure currently known to medical science. ( Enclosure 2: Who's Who in Technology, 1982; Who's Who in Technology Today, 1984; Who's Who in Technology, 1989.)

If your claims were true, wouldn't your drug be one of the truly big wonder drugs of the late twentieth century?

Curiously, your list of diseases cured by your drugs (in your biographical sketches) omits PLS. For someone who claims to have toiled for thirty-three (33) years doing PLS research, this is most interesting.

E.    Does "Octacosanol"/Policosanol Cure Everything Claimed By Its Proponents?

There are many health claims being made about "Octacosanol"/policosanol. According to the American Council on Collaborative Medicine, it "has been effective in treating many cases of...muscular dystrophy, post stroke...and some paralytic conditions caused as a result of traumatic damage to motor nerves." It also increases muscle strength, endurance, vigor, reaction and recovery times. (See http://www.hsv.tis.net/dymedias/a/accm/PROCOSAN.HTM.) (April, 2001 UPDATE: This web site no longer exists.)

A group of Cuban researchers with two United States patents for policosanol, claim that it can lower cholesterol, prevent complications of hardening of the arteries, prevent certain ulcers and (amazingly) improve male sexual activity. (See http://164.195.100.11/netahtml/search-bool.htmland search for 5,663,156 and 5,856,316 in the field "Patent number"  for "all years".)

And the American Council on Collaborative Medicine also claims that it increases fertility and sperm production. (See http://www.hsv.tis.net/dymedias/a/accm/PROCOSAN.HTM.) (April, 2001 UPDATE: This web site no longer exists.)

But there's still more! Assuming that this stuff could create an army of super-potent, vigorous men, women will enjoy a "more comfortable pregnancy with less risk of toxemia and spontaneous abortion", according to the American Council on Collaborative Medicine. (See http://www.hsv.tis.net/dymedias/a/accm/PROCOSAN.HTM.) (April, 2001 UPDATE: This web site no longer exists.)

Ladies--haven't met one of these supermen? No problem! According to the Blue Ridge Mindbody Institute, it also helps women with premenstrual syndrome, and later with menopause. ( Enclosure 15: Web page from the Blue Ridge Mindbody Institute, located at http://www.ne-mindbody.com/pmssuppl.html--enclosed here because their server is frequently down.)

This stuff should be selling faster than Viagra--a true blockbuster drug if ever there was one! You should be a billionaire if all of this is true!

And, of course, it must all be true. Otherwise no one would make such marketing claims--right?

Wrong! The U.S. Federal Trade Commission (FTC) has brought charges against three companies alleging that they were falsely advertising Octacosanol.  All of the cases were settled prior to trial.

On April 27, 1995, the FTC announced that Nature's Beauty, Inc. agreed to pay $250,000 to settle charges that it made false statements that (among other things) scientific research showed that Octacosanol improved reaction time, reduced cholesterol levels, and strengthened muscles. (See http://www.ftc.gov/opa/predawn/F86/viobin.htm.)

Previously, on October 9, 1986, the Federal Trade Commission charged that Viobin Corporation and its parent company, A.H. Robbins Co., Inc., made false and unsubstantiated claims about their wheat germ oil product and its active ingredient, Octacosanol. Under a proposed settlement, Viobin and Robbins were prohibited from claiming that wheat germ oil products containing Octacosanol "help improve endurance, stamina, vigor, or any aspect of athletic fitness, or that octacosanol is in any way related to body reaction time, oxygen uptake, oxygen debt, or athletic performance. (See http://www.ftc.gov/opa/1995/9504/natbount.htm.)

As an aside, I discovered that triacontanol (C-30) was shown to be useful in treating sewage sludge. (See http://164.195.100.11/netahtml/search-bool.htmland search for 4,246,100 in the field "Patent number" for "all years".)

F.    Your Claim That You Worked With Dr. Forbes Norris on a PLS Study was a Lie

You mentioned in your letter to me (enclosure 1, page 2) that in 1983 you worked with Dr. Forbes Norris of the Pacific Medical Center in a PLS study.

Dr. Norris, a world-renowned motor neuron disease researcher and physician passed away in 1993. His passing makes it impossible to ask him about your supposed work together. But Delores Holten Norris worked very closely with her husband, Forbes Norris, on all of his research, including research in which he was collaborating with others outside of the Pacific Medical Center. I talked to Mrs. Norris.

She stated that her husband never worked with anyone with the name of Helmut Prahl. She further indicated that your claim, that "the etiology of PLS...is quite well understood", (enclosure 1: letter, page 1.) is false.

G. Your Drug Was Tested In A Real Medical Study For ALS--It Failed

I believe that I have found your connection to Dr. Forbes Norris. Although there was a connection, it did not involve PLS, and you did not work with him.

In the mid-1980's someone was marketing a product called "Octacosanol" to ALS patients claiming that it could cure ALS. (Was this you?) Some ALS patients were claiming that Octacosanol was stopping their ALS.

The ALS Association heard about the claims being made about Octacosanol and contacted Dr. Forbes Norris about what they'd heard. He conducted a double blind, placebo controlled trial of Octacosanol in ALS patients. (Enclosures 13 and 14: Norris, Denys, and Fallat, Trial of Octacosanol in amyotrophic lateral sclerosis, Neurology, Sept. 1986, 36: 1263-1264, (Hereafter called "Norris 1".); and Norris and Denys, Nutritional Supplements in Amyotrophic Lateral Sclerosis", Adv Exp Med Biol. 1987; 209:183-9.) (Hereafter called "Norris 2".)

You supplied the Octacosanol to Dr. Norris. That was your only connection to him. ( Enclosure 13, Norris 1 at 1264, and enclosure 14, Norris 2 at 188.)

Dr. Norris concluded that your "Octacosanol" had no effect on ALS. Sadly, all of the ALS patients in his study continued to deteriorate.  This occurred both for patients who were given your "Octacosanol" and for those who received the placebo.

In spite of their continuing neurological deterioration, three (3) of the eleven (11) patients who received your Octacosanol felt that it helped them. But so did three of the patients receiving the useless placebo.

Why can't you do a similar study for PLS? Dr. Norris' study was neither large nor expensive. Further, he obtained his own funding for the study.  If your PLS drugs really work, prove it.

In spite of Dr. Norris's study, three (3) years after it was published you still listed your "drug" in Who's Who in Technology, 1989 (Enclosure 2) as a therapy for ALS. How could you do this when the scientific evidence showed it to be useless?

Even worse, in fact much worse, the PLS Newsletter recently stated that you provided your "drug" to an ALS patient from the early 1980's until his death this year--fourteen (14) years after Dr. Norris proved it to be useless. (PLS Newsletter, Spring, 2000.)

How could you do this? How could you take his money for so long knowing that your "drug" would do nothing to slow his ALS? And how can you still claim (through Frank Levy) that C-3036 is the "workhorse in the treatment of...ALS"? (PLS Newsletter, Spring, 2000.)

You pass yourself off as a man of science. Yet the only scientific study done on your drug shows that it is useless for ALS. Your words of praise for your ALS drug are those of a huckster, not those of a man of science.

H. Your "Octacosanol" is also Useless for Multiple Sclerosis

Someone (I'm not positive who it was) marketed Octacosanol as a cure for multiple sclerosis in the 1980's. It has been determined to be "ineffective" in treating multiple sclerosis. (Call the National Multiple Sclerosis Society at (212) 986-3240. See also Therapeutic Claims in Multiple Sclerosis, 4^th Edition, 1996.)

I. Your "Octacosanol" is also Useless for Parkinson's Disease

In the mid-1980's, someone (I'm not sure who) was marketing Octacosanol as a cure for Parkinson's Disease. The marketing campaign was short-lived.  Octacosanol "was not found to be useful for treating Parkinson's Disease symptoms." (Parkinson's Disease Foundation, Inc., (212) 923-4700.)

J. You Have No Basis To Believe That Your Drug Could Treat PLS

When real medical scientists try a new drug to fight a disease, they have a medical basis for doing so. Enough basic research has been done to develop a theory of the cause of the disease. A drug has then been developed. The drug has been tested on animals.

When human trials for neurological treatments begin, patients are examined. A complete neurological work-up, including neurological testing, blood tests, spinal fluid analysis, EMG test, MRI scans and family history, is conducted. Past medical records are reviewed. This is all done both to verify the diagnosis, and to take baseline recordings of each patient's condition prior to treatment.

Double blind, placebo controlled trials are then begun.

Contrast the scientific approach with yours.

You never did any work to determine the cause of PLS. (No one else has either.)

In the absence of any understanding about the cause of PLS, you tried a cheap, now-discredited, nutritional supplement (Octacosanol) on one ALS patient. When he told you that it worked, you marketed it to others.

When a scientific study proved that your "Octacosanol" was useless against ALS, you ignored its findings. As the market for Octacosanol nonetheless dried up among ALS patients (and MS and Parkinson's disease patients), you started marketing it to PLS patients.

No need for real scientific research to develop a theory of the cause of PLS--or even to determine if it is a separate disease entity from ALS. No need for animal studies. No need for double blind, placebo controlled human trials--even on a small scale. No need to see your patients' medical records, including their MRI's, EMG's, spinal fluid analyses, neurological examination results, and blood tests.

No need to ever see your patients in person to perform a neurological work-up, including neurological testing, blood tests, spinal fluid analysis, EMG test, MRI scans and family history.

You verify their diagnoses, and take "baseline recordings" of their condition over the phone.

You don't need a lab to conduct your "research". You just need a desk and a phone to field prospective sales calls. And you've admitted that you do nothing in your real lab other than make batches of your compound every two to three (2 - 3) years.

You started a marketing campaign for your drugs through the PLS Newsletter .You concocted a story claiming that since 1967 you've been "conducting an advanced research program in motor neurone diseases, and specifically PLS" in your "4000+ square foot research laboratory dedicated to this research". (Enclosure 1: letter, page 1.) As an added touch, you claim to have developed "essentially 100% efficacious drugs" to stop its progression. (Enclosure 1: letter, page 1.)

You must admit, PLS patients are perfect for your scheme. Traditional medicine offers us nothing, so we are desperate. Our disease progresses slowly making it very difficult to detect its progression over short periods of time. During that time, you have convinced many of us that your drug has stopped the progression.

You plant the idea that anyone who stops taking your drug will quickly deteriorate down to the level that they would have been had they never taken your drug. (Enclosure 12, Letter to William Figueroa, M.D.; and Letter to the Editor of the PLS Newsletter, December, 1994, by Helmut F. Prahl.)

This makes it psychologically very difficult to stop taking your drugs based on mere doubt. Nonetheless, four out of the five PLS patients that I contacted who took your drug had the courage of their convictions to stop taking it--with no negative effects.

To market your drug, you cleverly ask your believers to write letters to the editor of the PLS Newsletter praising your drug. You avoid making the statements yourself. Curiously, when your believers turn into doubters, you do not encourage them to write to the PLS Newsletter so that other patients can obtain the whole truth about your drugs.

K. How Could You Possibly Know That A Deficiency Of Your Drug Causes PLS?

You claim that PLS is caused by a deficiency of the substances in your pills. (Enclosure1: letter, page 1.) If this is true, you must have tested PLS patients and noticed the deficiency. Was their blood tested? Or were there concerns about the blood-brain barrier so that cerebrospinal fluid was tested instead? Where were the results published?

Why don't you simply test each new PLS patient that requests your help to determine the type and amount of the deficiency? Then, instead of varying dosage levels and drug type as you learn more subjective information from your patients over the telephone, you could determine the exact type and amount of the drug that each patient needed when they began treatment. This assumes that you actually believe in your own statements.

Do you have research that shows that C-30 (a plant fertilizer and sewage sludge treatment additive) and C-36 is found in and needed by the human body? Is there research showing that it is deficient in PLS patients?  Did you also test patients with ALS, multiple sclerosis, neuropathies, Parkinson's disease, cerebral palsy, stroke, etc. (Enclosure2: Who's Who in Technology, 1982; Who's Who in Technology Today, 1984; Who's Who in Technology, 1989.) before claiming your drugs as therapies for those diseases? Do you actually expect anyone to really believe this?

Many drugs, like insulin, have to be injected into the bloodstream to get them there. This avoids putting them through the digestive system.  But your drugs are swallowed.

Have you checked to ensure that your drugs do not simply pass through the digestive system to the "outside world"? Is there research showing that the digestive system does not metabolize your drugs into something else before they enter the bloodstream? Further, how do you know that if your drugs get into the bloodstream they will pass through the liver and kidneys, and then cross the blood-brain barrier and actually go to the brain and spinal cord?

We both know that there is no research showing any of this. Your work in your lab is limited to making batches of your drug every two to three (2 - 3) years.  (Jim Mueller, Town of Middleton, (608) 833-5887; and Jim Musser, Assessor, Town of Middleton, (608) 827-1050.) You have done no scientific research in your lab about any aspect of any neuromuscular disease. But you don't need scientific research. You've got desperate patients who you can con with your stories.

L. Your Claim That C-3236 Was "immediately...extremely effective" Is Nonsense

You mentioned (enclosure1: letter, page 1) that in the early summer of 1997, you designed C-3236 (dotriacontanol and hexatriacontanol) and synthesized a laboratory sample. You added that "(t)his was provided to one PLS type-1 patient, who immediately reported that it was extremely effective."

How can this be? PLS is a slowly progressive disease. You told me on the phone that your drug does not reverse the damage done by PLS, but that it stops its progression, and that it would take quite a while to notice any effect.

How can a drug that stops a slowly progressive disease, but does not reverse its effects, be "immediately...extremely effective"?

M. The Plant Growth Regulator Connection

One of the substances listed as an ingredient in both C-3036 and your "Octacosanol" is triacontanol (C-30). As you know, triacontanol is a plant growth regulator. (See the U.S. Department of Agriculture's National Agriculture Library at http://www.nal.usda.gov/ag98/index/agricola-a.html and search for "triacontanol".)

Triacontanol stimulates plant growth, and is contained in several plant fertilizers. (See http://www.bradfieldind.com; and http://www.nitrosol.com/intro2.html--click "What is nitrosol".)

Based on your membership in the Plant Growth Regulator Society of America, and your lack of membership in any organization associated with the fields of molecular neurobiology or neuromuscular disease, you seem to be more interested in triacontanol as a plant fertilizer than as a drug.

It appears that with no medical or scientific basis, you decided that an inexpensive chemical that could stimulate plant growth could be marketed as a growth stimulant for human nerve cells. (I use dried rat and chicken excrement to fertilize my lawn. I hope this doesn't give you any new ideas about an even cheaper "human neuronal growth stimulant".) You developed a pill that contained triacontanol, and other similar chemicals such as octacosanol.

Why you think that a component of fertilizer, that is also useful in treating sewage sludge, will stop PLS is beyond me. Certainly as a chemist interested in fibers and polymers you have no rational basis to make such a claim. Your experience as a real estate broker/developer and chemistry lab, institute and tax-exempt foundation executive also provide you with no rational basis for such a claim.

N. (April 20, 2001 UPDATE: The conclusion previously in this section was incorrect. The entire section has therefore been deleted.)

O. It Is Not Illegal For You To Accept Checks Or Money Orders

You claim that you must accept cash only for your drugs because you "are prevented, by law, from accepting checks, money orders, or other instruments of that type." (Enclosure16, "Our Policy on Checks".)

This is not true. Checks and money orders are perfectly legal tender in this country.

You were born on October 16, 1933, making you sixty-seven (67) years old. You undoubtedly collect Social Security benefits. Have you always refused your Social Security checks?

Did you refuse to accept payment by check for the land that you sold in Bokeelia, Florida, back on February 2, 2000?

The only problem with checks is that after they are cashed/ deposited, they can be traced. The back of a check would identify your bank account. It would also show whether the money went into a corporate account or your personal account.

Further, if you do not claim the money you make by selling your PLS drugs on your income tax returns, checks would leave a "paper trail" that could help prove that your income is higher than the amount you claim. (I have no evidence one way or the other that indicates whether you report all of your PLS drug money to the IRS. I am simply aware of others who run cash businesses, some of whom deliberately underreport their income.)

P. Your Methods Of Testing Whether Your Drugs Work Are Not Valid

You now claim that your drugs' effectiveness can be evaluated by timing how long it takes to walk a fixed distance every day.

John Fink, M.D., a neuromuscular disease researcher at the University of Michigan Medical Center is studying the cause of Familial Spastic Paraparesis--a disease somewhat similar to PLS. He has written that for slowly progressive neuromuscular diseases it is practically impossible to use measures of physical ability to determine whether a drug was effective in reducing or stopping the rate of progression of the disease.

"Measures of physical abilities (muscle strength, tone, ability to walk, for example) are also variable and dependent on many factors such as physical therapy, cardiovascular conditioning, and anti-spasticity medications. These variables would make it difficult to assess objectively whether potential treatments were beneficial (or produced adverse effects)." (FSP/HSP Discussion Group, May 6, 1999.)

Of course, you are not a neurologist, and have no idea of the neurological tests that might be done to test the effectiveness of a real PLS cure.

Q. You Did Not Discover PLS "Type 2"

In 1996, Frank Levy, Ph.D. reported that you had discovered PLS Type2--a version of PLS that affects speech and swallowing. (PLS Newsletter, Winter, 1996.) Up until that time, "(i)t was thought that the only variety of PLS was the kind your editor had, the kind we now call Type1." (The editor of the PLS Newsletter has PLS that affects only his legs.) (See "Age at First Symptoms", PLS Newsletter, Winter, 1998-1999.) You made your "discovery" after you and your laboratory had supposedly been "conducting an advanced research program in motor neurone diseases and specifically PLS" for twenty-nine (29) years (since 1967). (Enclosure1: letter, page 1.)

That PLS can affect speech and swallowing was first published in the medical literature nineteen (19) years before you "discovered" it. In fact, it has been published at least eight (8) times before your "discovery".  A list of articles mentioning speech and swallowing difficulties as symptoms of PLS follows:

        1.      Fisher CM: Pure Spastic Paralysis of corticospinal origin. Canadian Journal of Neurological Science, 1977; v. 4, pp. 251-258,

2.      Beal MF, Richardson EP: Primary lateral sclerosis: A case report. Archives of Neurology 1981, v. 38, pp. 630-633,

3.      Gastaut JL, Michel B, Figarella-Branger D, Somma-Mauvais H.: Chronic progressive spinobulbar spasticity. A rare form of primary lateral sclerosis. Archives of Neurology 1988, v. 45, pp. 509-513,

4.      Younger, D.S., Chou, S., Hays, A., Lange, D.J., Emerson, R., Brin, M., Thompson, H., and Rowland, L.: Primary Lateral Sclerosis: A Clinical Diagnosis Reemerges, Archives of Neurology 1988, v. 45, pp. 1304-1307,

        5.      Pringle, C.E., Hudson, A.J., and Ebers, G.C.: Primary Lateral Sclerosis: The Clinical and laboratory Definition of a Discrete Syndrome, Canadian Journal of Neurological Science 1990, v. 17, p. 225,

6.      Pringle, C.E., Hudson, A.J., Munoz, D.G., Kiernan, J.A., Brown, W.F., and Ebers, G.C.: Primary Lateral Sclerosis: Clinical features, Neuropathology and Diagnostic Criteria, Brain 1992, v. 115, pp. 495-520,

7.      Gascon, G.G., Chavis, P., Yaghmour, A., Stigsby, B., Shums, A., Ozand, P., and Siddique, T.: Familial Childhood Primary Lateral Sclerosis with Associated Gaze Paresis, Neuropediatrics 1995, v. 26, pp. 313-319, and

8.      Casselli, R.J., Smith, B.E., Osborne, D.: Primary Lateral Sclerosis: A Neuropsychological Study, Neurology 1995, v. 45, pp. 2005-2009.

I cannot understand why a chemist/real estate developer who claims to have been researching the cause and cure of PLS since 1967, never read even basic medical journal articles about PLS--articles so easy to find that even I could find them.

Why were you so completely unaware of PLS's effects on speech and swallowing for so long? And why are you claiming credit for discovering what real neuromuscular disease researchers have now known for over two decades?

R. There Is No Such Thing As PLS "Types 1 & 2"

There is no mention in the medical literature about PLS "types 1 and2".  Dr. Robert Brown, a world-renowned neuromuscular disease researcher at Harvard University Medical School, confirmed that the terms "type 1and 2" are not used by the scientific or medical community in describing PLS.

I have noticed in the PLS Newsletter, that over the years you seem to come out with new formulations of your drugs. PLS patients who notice no effects of one drug are given new dosage levels.  If, after more time elapses, no effect is noticed, you can claim that they have a newly discovered form of PLS, and need a new drug.

Don't you come out with new drugs as a clever tactic to postpone the day that your patients lose faith in you, and stop buying your drugs?

S. You Spent $ 3 Million To Develop Your Drugs, But Can't Spend A Nickel More To Test Them

You stated (enclosure1: letter, page 1) that you "constructed a 4000+ square foot lab dedicated to (motor neuron disease) research".  It occurs to me that a 4000+ square foot laboratory is a large lab. In fact, it is larger than most two (2) story houses.

With all of the space in your laboratory, you must have had other scientists working there. Perhaps you also collaborated with others (other than Dr. Forbes Norris) doing research on neuromuscular diseases. Who were these people? Where did you publish your results? If your results were not published, why did you not want the entire medical community to share in your discoveries? Wouldn't this help the very people that you currently claim that you help?

Where was this lab? It certainly was not on Struck Road/Watts Road in Middleton, Wisconsin. The lab that you built there was for the Dynatron Research Corp.--the contract research lab that did work on "polyolefin modified starch" and on a gasket forming process. (Enclosure5 at page 772. See also your patents above at enclosure 3.)

April 30, 2001 UPDATE: Dr. Prahl now claims that the lab is at the Struck Road/Watts Road property.

You stated (enclosure1: letter, page 1) that you "funded this program in six figures annually, in terms of today's dollars". Was this out of your own pocket, or did you obtain financing from outside investors?  If outside investors were backing you, why didn't they invest heavily once you had developed "essentially 100% efficacious drugs"? (Enclosure1, page 1.)

If you actually spent a hundred thousand dollars ($100,000) a year ("in terms of today's dollars") of your own money for almost thirty (30) years financing your PLS lab, why did you stop spending money once you had discovered the cure? Certainly if you can come up with $3,000,000 to discover the cause and cure of PLS, you can come up with some more money to prove that you have found the cure.

Alternatively, if you no longer can come up with the money, but really believe what you say, you could approach a neuromuscular disease research scientist, tell him/her of your miracle discoveries, and ask him/her to obtain a grant and test your drugs. (Just like Dr. Norris did when "Octacosanol" was "the cure" for ALS.) Why not?  What are you afraid of?

T. Many Venture Capital Firms Invest In Companies That Have Developed Promising New Drugs

I have a friend who works in a venture capital firm. The firm funds the research necessary to obtain FDA approval for new drugs. They do this by purchasing shares of small companies proposing new drugs. If the company obtains FDA approval for its new drug, the venture capital firm shares in its growth.

Only one out of every ten drug companies that my friend's employer invests in ultimately obtains FDA approval for a new drug. Nonetheless, the profits on the winners more than makes up for their loses. They fund research for drugs that cure diseases with large patient populations and very small patient populations. In either case, they make money--if the drug works.

Prior to investing in a new drug, the firm that my friend works for thoroughly checks out the company proposing the new drug and its proposed new drug. They do not invest in companies or drugs that they believe are frauds or hoaxes.

There are many venture capital firms like the one that my friend works in that invest in promising new drugs. Many are listed in the Pratt Guide to Venture Capital Sources that is available in the reference section of most libraries.

You are a businessman in addition to being a chemist and a real estate broker/developer. If you really believe that you discovered the cure for PLS, why haven't you tried to get venture capital funding like everyone else developing new drugs?

You certainly know how to sell your ideas to other companies whom then manufacture and market the product. You granted a license to Twinlabs Corp. to manufacture and sell your Octacosanol. (See http://www.lef.org/newshop/items/item00104.html.)

You also sold the rights to two (2) of your patents:

        1.      You sold the gasket forming process patent to Fel-Pro Incorporated of Skokie, Illinois, and

        2.      You sold the dyeable polypropylene-stearic acid fiber blend patent to Monsanto Co.

(Enclosure 3: Chemical Abstracts 64:P 11373f; and the U.S. Patent and Trademark Office, Patent Full Text and Image Database, available at http://164.195.100.11/netahtml/search-bool.html.)

If your drugs are everything that you say they are, you would have found a firm willing to invest the money to bring your drugs to market. At a minimum, you would have made hundreds of thousands of dollars in royalties, while another company did the actual work in producing and distributing the drugs.

Why have you decided to forgo the large amounts of money that you could earn if your drugs were FDA approved?

U. The FDA Is Not The Problem

You stated that the real problem is the FDA...that they require " irrespective of any orphan drug law, that a new drug be studied in double blind, placebo controlled trials involving about 2000 patients. That's about four times the total number of known PLS patients in the whole world!" (Emphasis yours.) (Enclosure1: letter, page 2.)

I called the FDA and found otherwise. Where a disease is rare, commonsense and the FDA require a smaller study size.

In fact, section 528 of the Federal Food, Drug, and Cosmetic Act states that an orphan drug's developer can design protocols to clinically investigate a drug, in light of the fact that the drug is for a rare disease.  (See http://www.fda.gov/orphan/about/odreg.htm.)

But I did not stop my research on this issue with the FDA.

I also called the Pharmaceutical Research and Manufacturers of America. (PhRMA) (1100 Fifteenth Street, Washington, D.C. 20005; 202-835-3400; http://www.phrma.org.) Burt Spilker, Ph.D., their Senior Vice President for Scientific and Regulatory Affairs, told me that there is no FDA rule requiring 2000 patients in an FDA required drug study.

"The FDA is totally, totally reasonable", said Dr. Spilker. "Many, many drugs have been approved with less than 100 patients total" in the study.

Dr. Spilker noted that "if there is a rare disease, then very few patients need to be in clinical trials." "I had many drugs approved with less than 100 patients when I was the head of a company", he added.

Adagen is an example of an FDA approved drug that was developed for an extremely rare condition. Adagen is an antibiotic that was approved to cure severe combined immunodeficiency in infants. There are less than 40 patients per year in this country with this disease. Adagen was tested on less than 20 patients before the FDA approved it.  It was developed by Enzon Corp., from Piscataway, New Jersey.

Approximately two hundred (200) other drugs have been approved to treat rare diseases through FDA's orphan drug program. (See http://www.rarediseases.org/new/health_environment.htm.)

If Adagen can receive FDA approval with 20 patients in its clinical trial, and 200 other drugs can be FDA approved for rare diseases, then your drugs can be tested and approved too--if they are legitimate.

I think that you'll have a real problem showing that your drugs are legitimate. You created a false story about your background. A corporation that does not appear to exist is named on the label of your pill bottles as their distributor. You have published nothing about your supposed work, and applied for no patents to protect your alleged discoveries. And your claim that your drug is "100% efficacious" is wrong.

Further, your statements about the FDA drug approval process and the orphan drug law are false. You have either read the FDA rules and deliberately lied about them, or you have no idea what you're talking about, and just made up a story. Either way, your lack of honesty does not inspire confidence.

The problem is not the FDA. The real problem is that your drugs do not work, you know it, and you must make up false stories to sell them to desperate patients.

V. You Don't Seem to Understand All of the Federal Orphan Drug Act

You state that "the orphan drug laws are primarily designed to shield a producer of an orphan drug from competition for seven years." You fail to add the other incentives to develop orphan drugs for rare diseases that are contained in the law. These incentives are significant.

First, Section 5 of the Act authorized the issuance of federal grants to help develop drugs for rare diseases. (See http://www.fda.gov/orphan/ABOUT/oda.htm.) Congress appropriated $12.5 million to the FDA's Office for Orphan Product Development in the fiscal 2001 budget for such grants. (See http://www.rarediseases.org/odu/june_00.htm.)

Further, there is a 50% tax credit for clinical research and testing expenses for the development of orphan drugs to treat rare diseases. (See http://www.fda.gov/orphan/ABOUT/taxcred.htm.)

It appalls me that you appear to be unaware of this information. Anyone looking for even basic information about the orphan drug law would learn this. Do you really not know the basics of the orphan drug law, or have you simply decided to ignore part of it in your sales pitch?

W. Your Claim That The Cause Of PLS Is "Well Understood" Is Absurd

You claimed that as a result of your work "the etiology of PLS, and several other motor neurone diseases, is quite well understood now."(Enclosure1: letter, page 1) The three world-renowned neuromuscular disease researchers that I have spoken to disagree. They are Dr. Robert Brown of Harvard University Medical School, Dr. Teepu Siddique of Northwestern University Medical School, and Dr. Stanley Appel of Baylor University. (I did not speak to Dr. Siddique directly. I spoke to him through his colleague, and wife, Nailah Siddique, RN, MSN.) These scientists are currently trying to determine the cause and the cure of neuromuscular diseases.

Do you really believe that the federal government and various private foundations would spend millions of dollars every year for neuromuscular disease research if, as you say, "the etiology of PLS and several other motor neurone diseases, is quite well understood now", (enclosure1, page 1) and if your drugs really cured "ALS, multiple sclerosis, neuropathies, Parkinson's disease, cerebral palsy, stroke etc." (Enclosure2: Who's Who in Technology, 1982; Who's Who in Technology Today, 1984; Who's Who in Technology, 1989.)   Oh, you forgot PLS.

You were a chemist, a chemistry lab executive, a real estate broker and developer. Do you really expect me to believe that without any advanced or even basic education or experience in neuromuscular diseases, you discovered "the etiology of PLS, and several other motor neurone diseases" (enclosure1, page 1) in your limited spare time? And further, that you did in your limited spare time what teams of others, properly educated and trained for the task, have not yet been able to do working more than full time?

If you actually believe what you say, please contact President Bill Clinton immediately. Tell him that you have information that is medically unproven and not published in any medical journal, that could help him slash millions of dollars in unnecessary neuromuscular research from the National Institute of Neurological Disorders and Stroke's $903 million budget (FY 1999). (See http://www.ninds.nih.gov/neuro2000/NINDS_Today.htm.)

Also, please tell Mr. Jerry Lewis, since the Muscular Dystrophy Association spends millions of dollars every year funding research on diseases you claim to have already cured. (See http://www.mdausa.org/disease/index.html for the list of 40 neuromuscular diseases that the MDA is combating with research funds.)

I'm sure that there are other disease foundations--such as the ALS Association, Multiple Sclerosis Society, Parkinson's Disease Foundation, Cerebral Palsy Association and others--that would love to know that they can also stop their research--you have all of the answers.

IV. MY PERSONAL CONCLUSIONS:

If you really believe that your drugs can stop the progression of PLS, wouldn't you be honest about who you are and what you have done?

Would you:

-falsely claim to be a molecular neurobiologist;

-falsely claim to have been researching PLS since 1967, in "a 4,000+square foot research laboratory dedicated to this research";

-hide your true past as a chemist interested in fibers and plant growth regulators, a real estate broker/developer, and a businessman;

-claim that your "drugs" are 100% effective when you know of at least seventeen (17) PLS pals who stopped taking them after they determined that your drugs did not stop the progression of their PLS;

-falsely claim that your "drug" can treat a whole host of neurological conditions when patients groups for these diseases say that your Octacosanol does not work;

-accept cash only and falsely claim that you "are prevented by law, from accepting checks, money orders, or other instruments of that type";

-make up phony stories about the FDA drug approval process;

-make up additional phony stories about having worked with Dr. Forbes Norris doing PLS research;

-fail to publish your work in reputable medical journals, when you have published your real work in chemistry journals;

-join the Fiber Society and the Plant Growth Regulator Society of America, but fail to join any organization concerned with neurological diseases or medicine; (Are you really more interested in triacontanol as a plant fertilizer than as a medicine?)

-fail to protect your alleged work with a patent, as you have done with your real chemical inventions;

-operate "underground"?

As should be painfully obvious by now, I have formed the opinion, based on my investigation, that your claims are false. Further, I believe that you are well aware that your claims are false.

I believe that you are selling false hope--an oxymoron. Knowing that we are desperate for a cure, makes it easy to sell us your "snake oil".  I believe that you are taking advantage of our desperation for your own financial gain.

You licensed Twinlabs Corp. to market your octacosanol/policosanol--a cheap, now discredited, nutritional supplement. Numerous, ridiculous claims have been about octacosanol/policosanol. You sold it as a cure for ALS. When it was proven to be useless against ALS and the market for it had dried up among ALS patients, you simply moved to a new disease--PLS. And now you claim it as a cure for both ALS and PLS.

To gain credibility, you made up phony stories about your background as a molecular neurobiologist and about how you've been studying PLS for decades in your 4000+ square foot laboratory "dedicated to this research". You also made up stories about why your drug can't be FDA approved, and why you must market it "underground".

You know that it will take most PLS patients a long time to notice that their PLS has progressed while on your drug. During this time, you pick their pockets.

When a patient finally complains that their PLS has progressed, you alter their dosage. More time passes. More money flows.

Still more progression--change to a newer one of your PLS drugs. The money continues to flow. And so it goes.

Although I believe that you know nothing about the true cause and cure of PLS (no one else does either), I believe that you are a genius at understanding the emotional turmoil that we go through. And you have shown an exquisite ability to mine that turmoil for dollars.

In short, I believe that your actions are despicable.

How dare you Helmut Prahl! How dare you treat us as a bunch of ripe wallets--ready for your plucking!

And how dare you try to stop efforts to begin real PLS research!

I hope that by exposing your rotten scheme, I will help to put an end to it.
 
 

cc. Frank Levy, Ph.D., Editor, PLS Newsletter

Jennifer Thomson, Webmaster, PLS Awareness Website

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