Weird Science

Even though there's nothing wrong with him, Gary Prater swallows approximately 100 pills a day. In the past ten years, he hasn't even had a cold. And he'd like to keep it that way. He also wants to avoid contracting diseases such as cancer, hepatitis, and Lou Gehrig's. So every three to four hours, he pops about 15 pills -- a combination of dietary supplements, vitamins, and herbal extracts.

With the help of these pills, Prater expects to live to the age of 115. "Give or take five," he says without a trace of humor.

He's standing in front of bottles of "Jason Winters Intestinal Cleaner" and "Super Colon Cleanser" in a Hollywood vitamin store called the Life Extension Nutrition Center. On the colon-cleanser bottle is a crude black-and-white sketch of a large intestine.

"How old do you think I am?" Prater asks a visitor.
"Um, 40?"
"I'm 52," he boasts. "I don't look bad for 52."

A slight, soft-spoken man whose brown hair has a strand or two of silver streaking through, Prater is manager of the store, which is located in a grubby strip mall on State Road 84 in Fort Lauderdale. The store is owned by the Life Extension Foundation (LEF), a nonprofit alternative health care organization that claims it brought in $27 million in sales and donations last year and boasts an international membership of 40,000 people.

LEF's "headquarters" is a small set of offices accessed by a door in the vitamin shop. Inside, more than a dozen employees sit in cubicles and advise members and nonmembers over the phone. An advisor's job is to sell pills, dietary supplements, and "alternative" treatments LEF claims stave off just about every disease, including AIDS, hepatitis, and cancer.

While conventional health care companies putter along, waiting for approval from the United States Food and Drug Administration (FDA) for new drugs and treatments, LEF acts swiftly and effectively. This is the organization's claim. But there's more. By providing customers with dietary supplements and advice on how to acquire FDA-rejected medicines from overseas, LEF can help slow the aging process. The ultimate goal, one that should be achieved by the year 2020, is to develop technologies and medicines that will enable human beings to live forever.

"I don't like death," Prater says.
And, like his fellow LEF members, he doesn't like conventional medicine. But in effect LEF is practicing medicine -- and without a license. Its scientific director, Dr. E.K. Schandl, is a nutritionist. Yet he says he's developed a diagnostic test for cancer that a) measures cancer-causing chemical levels more accurately than any mainstream test and b) is capable of predicting the onset of cancer as far as 12 years in advance -- claims licensed oncologists say are absurd. But, using his test, Schandl makes diagnoses, then prescribes treatments.

Included in the treatments are "drugs" that have not been approved by the FDA but, because of loopholes in federal laws, may be used as alternatives. Dietary supplements top the list, and LEF admits that it advises members on how to legally obtain drugs from overseas. But this all comes at a cost: Prater, for instance, spends $4000 a year on his pills, and the typical LEF member is advised to submit to a blood-test and pill-taking regimen that costs, on average, $1500 a year.

The money, of course, goes to a nonprofit charitable organization, which claims to donate millions of dollars a year to universities and research centers for antiaging and immortality research. But LEF officials refused to share with New Times any financial data or IRS forms that, according to federal law, must be open to the public upon request. Bill Faloon, LEF's vice president and cofounder, says he would like to oblige but adds that LEF's financial situation is "too complicated to talk about."

More important, to him, is that LEF is simply doing what the FDA, which is investigating the organization, has failed to do: provide, as quickly as possible, the most comprehensive medical treatment to save and lengthen lives.

"Bullshit," retorts James Cerda, a University of Florida medical doctor and a member of the Florida Board of Medicine. "Pardon my French, but the FDA is slow. But the reason they're slow is because they don't want to kill you. That was the first thing imprinted in my mind in medical school. We have got to be conservative. Not everything has to be a breakthrough."

LEF's methods are anything but conservative. And that's fine with members, most of whom have had it with mainstream medicine.

George Baxas, an LEF member since 1990, is typical. Middle-aged and relatively healthy, he takes about 25 capsules a day of folic acid, vitamin E, and LEF's own "Life Extension Mix" -- a combination of food and vegetable extracts, minerals, and vitamins -- at a cost of roughly $150 a month.

In March he paid $95 for a blood test recommended by LEF and offered at the vitamin store. The test showed he had a high level of the amino acid homocysteine in his blood. Prater, who has no medical training, is also an LEF senior advisor. He told Baxas that high levels of homocysteine may irritate the interior linings of blood vessels and lead to a stroke or heart disease.

Baxas says he brought this information to his doctor, who didn't know anything about the amino acid. He then consulted with Prater, who suggested he take four tablets a day of Trimethylglycine (TMG), a dietary supplement derived from beets, to reduce the homocysteine level. The cost of a 180-capsule bottle of the nutrient is $20, but, because Baxas is an LEF member, he gets 25 percent off. Membership costs $75 a year, $1500 for life.

"Most doctors have no idea what this is," Baxas says, referring to the TMG. "My doctor told me it may be 25 years before we know if that's any good. That's a bunch of baloney."

To find out if the supplement worked, Baxas paid another $95 for a blood test two weeks ago to measure the homocysteine level. He is still waiting for the results.

Anyone off the street can have his or her blood tested at LEF. For the purposes of this article, a New Times reporter called to make an appointment. "You're going to want to become a member," Joann, an LEF advisor, said almost immediately after picking up the phone. "It's going to be so much cheaper for you." The offer was declined, and an appointment was made for the next day.

Blood is drawn at the vitamin store, in the back in a room the size of a broom closet. Hanging above the door is a bright red sign that reads: "FDA Museum." The "museum" is really just a display of two dozen or so panels depicting alleged FDA atrocities. One panel features the illustrated cover of a book titled Murder by Injection: The Story of the Medical Conspiracy Against Americans. On another panel is an illustration of a man in a blue suit -- an FDA bureaucrat -- throwing books on a fire. The book titles include Eating For Health and Scientific Data. A sign hanging over both panels reads: "Gestapo-Like Raids on Legitimate Companies" -- an allusion to the FDA's raid on LEF headquarters in 1987.

But neither Joann nor Melissa Garcia, a 26-year-old trained phlebotomist, comment on the museum. First they get a few questions out of the way -- name, address, age -- then ask for $55.

Made payable to the vitamin store, the fee covers a test that measures the level of more than three dozen chemicals, minerals, and sugars in the blood and indicates such problems as inflammation, hepatitis, and risk for heart disease. After the fee was paid, the visitor was handed a 14-page pamphlet entitled "Your Laboratory Test Results." On the back was the name of the Hollywood-based outfit to which the blood samples are sent for testing: American Metabolic Laboratories. The lab's owner-operator is also LEF's scientific director, Dr. E.K. Schandl. Schandl is licensed in Florida as a nutrition counselor and clinical laboratory director, but nothing on the pamphlet indicates that he's a medical doctor.

Joann insisted, however, that Schandl is an M.D. as well. Garcia then put on a pair of latex gloves and a yellow smock, pulled out a sterile needle and began to draw blood.

State law demands that either a) a physician order a blood test or b) a physician give blanket approval for the administration of blood tests at a clinic. In the latter instance, that same physician must see the results of the blood test before making a diagnosis and prescribing treatment.

The man supposedly granting blanket approval at the vitamin store is Dr. Herbert Pardell, an Aventura-based osteopath who is also LEF's medical director. Dr. Pardell did not return phone calls for this article, but, according to his nurse, Diane Manet, he does not see the test results. That job is left to Schandl.

Before the blood test concluded, Joann suggested a visitor try Dr. Schandl's "Cancer Profile." At a cost of $310 for nonmembers, the test measures the levels of six different chemicals and hormones in a single blood sample and, according to Schandl, is capable of predicting the onset of cancer up to 12 years before it occurs.

"You should hear the calls [Joann] gets about it," Garcia said, enthusiastically. "She gets all these calls about it from all over the world."

If what Schandl claims about his test is true, he's the only person in the world capable of predicting the onset of cancer. But the half-dozen oncologists and health experts New Times interviewed said they'd never heard of Schandl or his test.

The only tests that even come close to predicting cancer are genetic tests for breast and ovarian cancers, according to Dr. Charles Vogel, the medical director for Columbia/ HCA Cancer Research Network in Aventura. And even if someone carries a "cancer gene," she will not necessary contract the disease, he said.

Oncologists use other blood tests to diagnose prostate and ovarian cancer in asymptomatic patients. A high level of prostate specific antigen (PSA) indicates prostate cancer, whereas a high level of CA-125 ("CA" stands for carcinoma) indicates ovarian cancer. Abnormal levels of such chemicals, including human chorionic gonadotropin (hCG), are referred to as "tumor markers," which doctors use to monitor the treatment of cancer. But, with the exception of PSA and CA-125, most tumor markers, including hCG, show up only if a cancer is in an advanced stage, according to Vogel.

Schandl claims, however, that his cancer-profile test is so sensitive, it detects the presence of cancer much earlier than other tests. He's able to do so, he says, because he measures the levels of six -- not just one -- chemicals with each blood sample. And, aside from detecting the presence of cancer, the test provides Schandl with "early warning signs" that, 10 to 12 years from now, cancer may develop. Part of Schandl's methodology is that he looks for chemicals other doctors don't even consider. For instance, he tests for levels of PHI, an enzyme that regulates anaerobic metabolism. The higher the rate of anaerobic metabolism, the quicker a cancer spreads, Schandl claims. So if a high level of PHI exists, along with high levels of two or three other chemicals, including hCG, cancer very well may develop down the road.

"Most doctors don't even know what it is," Schandl says, referring to the enzyme.

In fact most doctors, Vogel included, think the cancer-profile test is bogus.

Cerda, the University of Florida researcher, wondered why he'd never heard of Schandl or his diagnostic tool. He called Schandl's claim that he could predict cancer "akin to crystal ball gazing."

"This is something we've been trying to do for a long, long time, and no one's been able to do it," Vogel argued. "[Schandl] says he's done this on thousands of patients, but, in terms of where he's published his data and how solid his data are, it becomes highly suspect."

Both Cerda and Vogel wondered why Schandl's test had never been published in a major, peer-reviewed scientific journal.

"I haven't had time," Schandl contends. He did, however, offer a list of fifteen research articles he's written for scientific journals, including three on the cancer profile. Two of the three were published in German journals, however, and Schandl said he couldn't find a copy of the third.

As soon as Schandl makes a diagnosis, he instructs a cancer patient to make lifestyle changes and begin taking dietary supplements and herbal ingredients, which, he says, "can reverse the malignancy process."

Typically he tells patients to take a tablet form of the hormone DHEA, which he calls an "immune enhancer." He also suggests high doses of vitamin C and the herbal supplement echinacea, which Schandl claims prevent inflammations caused by cancer. LEF also recommends cancer therapy, which costs thousands of dollars a year and includes a seven-step program consisting of monthly blood tests, 12 nutritional supplements, and hundreds of herbs and mineral pills.

Mainstream doctors warn that "all-natural" alternative therapies may sound harmless, but in some cases they're not. DHEA, for instance, can cause hormonal shifts in women with certain forms of cancer. And echinacea comes from a flower related to ragweed, to which many people are allergic.

As a licensed nutrition counselor, Schandl is legally allowed to recommend dietary supplements to his patients. He's also a state-certified lab director, which allows him to conduct blood tests. Neither of these distinctions, however, allows him to diagnose or treat physical problems, according to Florida law. That right is reserved for physicians.

Schandl himself admits he walks a fine line. His resume states, in fact, that he is an M.D. Pressed on the issue, he admits, however, that he's not licensed to practice in the United States. The degree, he says, came from a university in Sri Lanka. But he refers to his clients as "patients," and LEF literature refers to him as a "doctor" whose cancer profile serves as "an early diagnosis, made possible by biochemical testing."

At the age of 60, Schandl is a short, compact man with a neatly trimmed mustache and slicked-back, graying hair. Born and raised in Budapest, Hungary, he moved to California in 1956. In 1962, the year he began attending junior college, he received word from Budapest that his mother had died of leukemia.

Schandl says his mother's death is what inspired him to develop better diagnostic tools and treatment for cancer. He received a bachelor's degree in analytical biology from the University of California in Santa Barbara in 1965, and two years later he got his master's degree in biochemistry from San Diego State University.

Schandl was then invited to study molecular genetics at Florida State University, where he received his Ph.D. in 1970. Schandl claims that the following year he was hired as an assistant professor of biochemistry at Nova University in Davie. But the university has no record of his employment. With a tinge of sarcasm, Schandl admits that Nova's administrators have probably chosen to forget him. While at Nova, he says, he researched viruses in a university building that was also home to a kindergarten program. As a result, administrators did not renew his contract in 1974, he adds.

Schandl claims he later became the chief of clinical chemistry at the now-defunct Community Hospital of South Broward, where he began developing what would later become his cancer profile. In the mid-'70s he continued his work at the Howard Hughes Research Institute, which, he says, was a part of the University of Miami.

But the Maryland-based research group has no record of Schandl. A spokesman said the institute did once have an administrative office in Coconut Grove, but it never provided funds for research in South Florida or anyone affiliated with the University of Miami.

When told of this discrepancy, Schandl clarifies by saying that he simply rented space and materials owned by the institute.

Schandl says he perfected the cancer-profile test throughout the '80s, while working as laboratory director at several South Florida labs. In 1994 he founded American Metabolic Testing Laboratories and, around the same time, heard Faloon talking about the Life Extension Foundation on radio shows. Schandl had seen LEF advertisements in newspapers, and he started picking up copies of Life Extension magazine. Although he was impressed with some of LEF's innovations, he noticed repeated inaccuracies in interpretation in its literature.

Feeling he could lend some credibility to the organization, Schandl offered to help LEF out as an unpaid consultant. Faloon says he thought it was a great idea: Members with questions could consult someone with expertise. Schandl was soon named LEF's scientific director, and in turn LEF began promoting the cancer-profile test and throwing blood tests his way. On his end Schandl promotes LEF's treatments and supplements.

A cozy relationship, for sure. But Clara Lawhead, a licensed nutrition counselor and the president of the Florida Council Against Health Fraud, says the LEF tests and treatments play on people's fears about death and aging. Moreover, patients spend hundreds of dollars a year on blood tests, then thousands more on LEF-suggested supplements, increasing both Schandl's and LEF's bottom lines.

"Anytime you find both the practitioner who offers a diagnosis and the treatment in the same facility, the patient should be wary," she warns.

In LEF's early days, there was no bottom line. What is now an organization that brings in as much as $27 million a year began in 1973 as just a dozen strangers from South Florida interested in a a topic that had recently popped up on TV talk shows: cryonics. Cryonicists believe that if you freeze a body after death, you can preserve it until a cure comes along for whatever disease the person died of, then revive that person and bring him or her back to life with the new medicine.

Joe Cannon, a pioneer in cryonics, began getting phone calls after his talk show appearances, so he put some of those callers in touch with each other. A group formed in South Florida and held monthly meetings to discuss ways to raise money to help fund cryonics research.

"It was based on a fear of dying," Glen Tupler, one of LEF's founding members, says of the group's motivations. "You don't want life to end, and it's hard to face reality that it's going to end. So you do anything you can to extend it."

In 1976 the group invited Saul Kent, a former writer for science magazines and journals and the founder of the New York Cryonics Society, to meet with them. One of the group members was Bill Faloon, a mortician and funeral director originally from Pittsburgh, who, like Kent, was interested in turning immortality into a full-time job.

Kent asked Faloon to help form a foundation to encourage antiaging research and provide alternative health information to its members. Faloon agreed, and in 1982 the Life Extension Foundation was formed as a nonprofit, tax-exempt organization.

It wasn't long before LEF found itself in the public eye. In 1987 Kent's 83-year-old mother, Dora, lay in a vegetative state in a California nursing home. One December day he checked her out and brought her to a cryonics laboratory in Riverside, California. She died there a few days later, and cryonics researchers loaded her up with barbiturates to slow the decomposition process, according to press reports.

With Kent's approval researchers lowered his mother's body temperature to below freezing and severed her head. The head, Kent reasoned, would be stored in a Thermos-like container and eventually resuscitated and reattached to a cloned version of his mother's body. Storing just the head would also be cheaper, and Kent figured that by the time researchers developed the technology capable of resuscitating his mother they'd also be able to clone her body.

The Riverside County coroner had other ideas. He believed the researchers had killed Mrs. Kent by giving her a lethal dose of drugs before she'd actually died. An investigation, however, yielded no evidence to support the theory. No charges were filed, and Mrs. Kent's head is still stored in a cryonics facility in Scottsdale, Arizona.

While cryonics was the starting point for LEF, the group quickly branched into other areas, such as herbal- and dietary-supplement and vitamin sales. LEF's main goal, Faloon says, is to develop life-extension therapies.

Vitamin sales pay for the majority of LEF's expenses, and the money raised, Faloon says, goes to people like Dr. Roy Walford, a pathologist at UCLA who has studied the effect of calorie restriction on aging. Walford said LEF is the only vitamin company he knows of that puts money into research.

Verifying Walford's claim isn't easy. Federal law requires charitable nonprofit agencies to disclose, upon request, the past three years of completed IRS-990 forms. Each tax form lists the charity's assets, expenses, and total contributions made that year. Florida law requires that the form also be filed with the state. As soon as the form is filed, the organization is officially registered with the state Department of Agriculture and Consumer Services. Faloon, however, refused to share copies of the IRS forms. And LEF has never filed with the state.

"It's just too complicated to talk about," Faloon said of the company's financial situation.

Bernard Singer, LEF's tax attorney, said accountants are now working on the 990 form, which should be ready by September. At that time, he noted, LEF "may also file some past tax forms."

Dom LaPonzina, IRS chief of communications in Washington, D.C., said LEF is listed as a nonprofit charity, but he would not comment on the status of the 990 forms. He noted that charities sometimes receive legal filing extensions. And sometimes they don't bother to file.

"Trust me," Singer said, "there is no hanky-panky at this organization. I am dead serious on that. You just happened to call at a bad time."

This isn't the first time LEF has had problems with the federal government. On February 26, 1987, the FDA raided LEF headquarters in a search for drugs federal agents believed were being illegally imported and stored by the organization. FDA regulations allow individuals to buy small amounts of unapproved drugs from overseas for personal use. Drugs may be brought back after trips abroad or received in the mail, so long as they aren't resold or considered a health risk.

In 1987 the FDA alleged that Kent and Faloon had created fictitious health care companies in Panama and Vienna to promote and sell in the United States unapproved drugs for such diseases as AIDS, herpes, and Alzheimer's.

The two men denied the charges and said they were merely providing LEF members with information about the drugs. But in 1991 a federal grand jury indicted Faloon and Kent on more than two dozen counts of conspiracy, importing unapproved drugs, and dispensing drugs in packages labeled as dietary supplements. The case dragged on for years, with hundreds of motions filed. But by 1996 the U.S. Attorney's office admitted it was unable to build a case against LEF and dropped the charges.

While the FDA continues to investigate LEF, Brad Stone, the FDA public information director, said he could not comment on the investigation. Instead he faxed New Times a copy of a 1987 statement, saying that "it should give you some insight."

"An ongoing FDA investigation of Life Extension Products of Hollywood, Fla., has revealed that the company marketed a variety of drug products with medical claims that were allegedly false or misleading," the statement reads.

When it comes to outfits like LEF, the FDA has considerably less bite than it once did. Until 1994, federal law prohibited companies from claiming that herbal and dietary supplements offered specific health benefits. If a company made such a claim, the supplement would be considered a drug and thus be subject to FDA safety regulation.

For example, LEF sells a mineral supplement called "Bone-Up," a high-potency calcium product made by a company called Jarrow. Under the old rules, LEF's vitamin store could sell Bone-Up but could not claim that it offered any health benefit either verbally or in its literature. But in 1994 the U.S. Congress passed the Dietary Supplement Health and Education Act (DSHEA), which allows companies to make health-benefit claims. In fact, Jarrow does so on its package, stating "research shows" that Bone-Up "may reduce the risk of osteoporosis."

Vitamin-supply companies like LEF are still prohibited from using the word "cure" in their pitches. But state health regulators worry that, after seeing any health claim at all, consumers may assume that the supplement is safe, effective, and approved by the FDA. In fact, because of DSHEA, the FDA never tests dietary supplements. Nobody, in effect, is minding the vitamin store.

The state health department is trying. According to Gloria Henderson, director of the department's Medical Quality Assurance division, two options are being considered at the moment: establishing standards for alternative medicine in the state, and putting together an association of alternative practitioners for the purpose of self-regulation. The Florida Board of Medicine also plans to meet in August to discuss the dietary-supplement industry.

In the meantime DSHEA's limitations are amply demonstrated in LEF's literature, which makes health-benefit claims that are impossible for a consumer to verify. Virtually every month Life Extension magazine throws out headlines such as "Breakthrough Drug For Alzheimer's Disease," "Cancer Breakthrough," and "Herbal Breakthrough" (for prostate cancer victims). The article accompanying the last headline mentions four different prostate-cancer studies but only lists where one of them took place.

Clara Lawhead, of the health fraud council, reviewed the ten-page section on AIDS and HIV therapy in LEF's protocol book and found extensive references to published medical journals but no footnotes or citations.

"The fact that they don't source with a footnote makes this garbage, because there's no way anyone could go back and hold them accountable," she noted. "Unless you give everything a reference, it's bogus, it's phony, it's a fraud."

The folks at LEF couldn't care less what the medical establishment thinks of their operation. Faloon says foundation members enroll, for the most part, because they're tired of "official medicine" and governmental overregulation.

As proof of LEF's regard for safety, Faloon notes that unlike doctors, who fear malpractice suits, LEF has never been sued. Besides, LEF urges each member to see a physician if he or she has a serious medical problem.

Faloon maintains a tidy office at LEF headquarters. The shelves behind his desk are lined with medical books. Next to the books is a "helmet" that looks like a pillowcase with two mirrors stuck to it. The mirrors are actually opaque visors, and the foam-lined helmet is designed to withstand heat of up to 2500 degrees Fahrenheit. Faloon wears it during airplane travel so that, in the event of a crash, his head will be protected and, if found, ready for freezing.

Faloon bounds into his office wearing a jet-black business suit and a pressed white shirt. At age 43, he appears fit and energetic and introduces himself with a singsong pronunciation of his name.

"This," he says, triumphantly holding up a stack of papers, "is the cure for cancer."

Earlier in the day, Faloon downloaded the material from Med-Line, a database of medical journals and scientific reports. The "cure" to which he's referring is the combination of the drugs Angiostatin and Endostatin, which can eliminate cancer in mice by restricting the amount of blood that flows toward a tumor. The drugs, developed by Judah Folkman, a Harvard University doctor, made national headlines back in May. But since then Dr. Folkman and others have warned against pinning too many hopes on the drugs. What works for mice will not necessarily work in humans.

That's of no consequence to Faloon, who refuses to wait the 12 to 18 months it takes the FDA to test new drugs. While he can't promise that the drugs won't harm humans, he points out that quite a few cancer victims don't have much time to live anyway.

"I don't believe it's a toxic substance," he says. "At this point the animals seem to do very well with it."

To get the drug on the market quickly, Faloon has been urging LEF members to contact their congressmen and put pressure on the FDA. He also plans to meet with a group of chemists he claims may be able to replicate the two drugs. Once the bootleg versions are created, LEF will let its cancer patients know where they need to go to get them.

Is that legal?
Faloon says that if LEF is merely providing its members with information that could help them live to the age of 115, what's the problem?

But is it safe?
Again, it's too soon to say, but Faloon's not worried. The people creating the drugs are scientists with whom he has worked before.

"No one has ever died from anything they've done," he said. "I trust them.

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