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The FDA's Panacea

    It is strange that we do not speak about Hitlers in the plural, as we speak about Quislings. The small Hitlers are around us every day, tormenting us with their promises, rejoicing in our weaknesses, demanding our trust, our lives, while remaining totally indifferent to everything except their thirst for power.

—Robert Payne, The Life and Death of Adolf Hitler

Answering a knock at the door of his Lake Charles, Louisiana, home about 8:30 a.m. on September 17, 2003, the man found three U.S. marshals with semiautomatic weapons who wanted to know if he was Greg Caton. When he said yes, they asked him to step out of the house and handcuffed his hands behind his back, claiming they had a warrant to search his home.

“Search for what?” he asked.

“First of all, we need to know where the battery acid is,” one marshal replied.

Battery acid?” Caton exclaimed. “I don’t have any battery acid in my home.”

The marshals entered the house, taking him along, and sat him down, handcuffed, while they searched. Other marshals assisted, until, Caton estimates, eight of them were going through his home. He asked no fewer than four times to call his attorney, but they refused to allow it. When he asked why, since he’d been arrested, their reply was, “You’re not arrested — you’re a detainee.” 

“This, to me, was the most amazing thing of all,” Caton says, “as if somehow that wording changes what is in fact happening. When I brought that up to my defense attorney, he said, ‘They’re not supposed to do that.’ I said, ‘Well, can’t we do something about it?’ He said, ‘No, because it’s your word against theirs — they can do whatever they want.’ ”

* * *

Greg Caton was a victim of “Operation Cure.All,” an initiative begun in 2001 by the U.S. Food and Drug Administration and the Federal Trade Commission. A press release on the FTC’s web site says, “FTC, FDA and other law enforcement agencies move to stop Internet scams for supplements and other products that purport to cure cancer, HIV/AIDS and countless other life-threatening diseases.” Unfortunately, the FDA has used this as an excuse to shut down businesses and arrest people whose products, though not recognized by conventional medicine, actually work — and are inexpensive and have few, if any, side effects.

At the time of the raid, Greg Caton, an herbalist and inventor, was founder and president of three companies. One, Lumen Foods, made soyfood products. Another, Preservx, made a food preservative Caton invented and patented that can be used in much smaller quantities than other preservatives. The third, Alpha Omega Labs, sold what the FDA and conventional medicine call “unproven” remedies for cancer and other health problems.

Many of these remedies Caton and his wife, Cathryn, a naturopathic doctor, had developed, some based on old formulas registered with the U.S. Patent Office. His web site, www.altcancer.com, contains extensive information and advice on dealing with cancer and other illnesses. The site says, “our primary focus is on ‘plant medicines’ that are proven to meet three criteria: (1) They must work, (2) They must be safe, and (3) They must be sufficiently inexpensive so that the average worker can afford the product(s) without distress.” He offered a money-back guarantee on everything he sold.

Alpha Omega’s first product and one of its most popular, Cansema Salve, contains chaparral, a traditional remedy for cancer, along with zinc chloride and other ingredients to facilitate its action. Starting with that one product, Caton built up his line to 350 or so items, some of which he had traveled the world to find. He had about a hundred thousand customers worldwide and grossed about a million dollars a year.

One product he carried was called hydronium, or H3O, a weak solution of “scalar energized” sulfuric acid used for a variety of topical applications, such as skin funguses, bites and burns, sore throat, and disinfectant. Caton is refreshingly candid on his web site, and in the case of H3O, this may have gotten him into trouble. In an extensive discussion, he says, “This is a solution you can easily swallow (more comfortably if diluted to a pH of 2.0, granted) at acidic levels, which, if we were talking about any other acid in the 0.0 to 0.5 pH range, would have potentially severe health consequences.”

Caton’s web site has testimonials about H3O — as it does about many of his products. He sold thousands of bottles to customers all over the world and hadn’t received a single complaint. Until, that is, a woman in Indiana used Alpha Omega’s Cansema Salve and H3O and a product from another company for what appeared to be a cancer on her nose and suffered damage. She filed a lawsuit against both companies, but an affidavit filed eight months after the raid doesn’t mention Alpha Omega or its products.

Alpha Omega’s records indicate that a year and a half after the incident with her nose, she attempted to return the H3O and another product, H3x, unopened. Alpha Omega declined, because the product was more than three months old, but the question arises how she could have suffered harm from the H3O if she never opened it. She also bought two more jars of Cansema Salve more than a year after the incident with her nose and returned them unopened for a refund two months later. Caton’s attorney points out, in a document filed with the court, that of the two companies involved, Alpha Omega “is the only insured party.”

Around the same time, a surgeon in Texas used H3O as a disinfectant to rinse out the site of a partial hysterectomy he performed. The patient developed “various complications,” according to the lawsuit she filed, which she blamed on the H3O “as well as the care and treatment” by the surgeon, the hospital, and the holding company that owned the hospital. In an August 2002 letter, a year before the raid on Alpha Omega, the Texas State Board of Medical Examiners cleared the doctor of wrongdoing after an investigation, saying “the evidence does not indicate a violation of the Texas Medical Practice Act.” 

These were the only lawsuits filed against Alpha Omega during its decade in business. From the FDA’s point of view, however, Caton was cynically selling battery acid and other dangerous products to unsuspecting customers, and he had to be stopped.

Caton says that the manufacturer’s safety data sheet (MSDS) and skin sensitivity test for H3O show that on human tissue, the product has the same corrosivity or causticity as water. Although neither document says this in so many words, the erythema/edema (skin redness/swelling) test, done on six rabbits by a testing laboratory in New Jersey, does show no discernible effect in two cases and a “very slight” or “barely perceptible” effect in four cases after twenty-four hours.

After seventy-two hours, no effect is discernible in any of them. The report says that the product “is not considered a primary skin irritant according to 29 CFR, Section 1910.1200. App A (1), 2001.” H3O was sold as a concentrate and was used in this form for the tests. Used as directed, it would be diluted approximately one hundred twenty-eight times (one ounce to a gallon of water).

The MSDS presumably intends to convey the same message but doesn’t do it quite so clearly. It says the product is “Non corrosive per 49 CFR 173.136,” that no labels are required, and that it “Contains no hazardous ingredients according to these citations.” Under “Effects of chronic over exposure,” it says “None” for eyes, skin, and inhalation and that ingestion is “Not a likely source of exposure. Dilute with milk or water.”

On the other hand, the sheet also says, “May be harmful if swallowed” and “Keep out of eyes and off skin.” It says users should wear safety glasses or goggles and impermeable gloves and that “A well ventilated work environment is recommended.” This appears to be boilerplate language that would be reasonable for any chemical one worked with on a regular basis, as opposed to something used occasionally for therapeutic purposes. Again, this applies to the concentrated version.

* * *

At the same time the FDA was searching Caton’s home, other marshals were searching his business premises and several properties he owned in Lake Charles, much to the consternation of his employees and tenants. The government brought in trucks to Alpha Omega and confiscated large quantities of raw materials and finished products, which they subsequently destroyed — essentially finding him guilty before his case was even heard. The centerpiece of the operation was a special truck for transporting hazardous materials, with “Sulfuric Acid” signs on the sides, which they used to haul away the H3O.

Cathryn Caton had been at the gym that morning for a workout, along with the Catons’ seven-year-old son, and arrived home just as Caton was being arrested. A neighbor who saw what was happening came out and took charge of their son, so Cathryn could respond to the situation inside.

The Lake Charles police chief, a former FBI agent, had also arrived, Caton says in a letter, and “told me to my face that he could ‘rip up the floors and tear out the walls’ if ‘we don’t get what we’re looking for.’ I will never forget this as long as I live. I was sitting at the West facing end of my dining room table with handcuffs on behind my back when he told me. I was really, really concerned that they were going to destroy our home.”

As it turned out, Caton was not only a detainee but an arrestee, and he was sent to the parish jail. “Jail” conjures up the image of a couple of cells in a police station or behind the sheriff’s office in an Old West frontier town, but in fact, Lafayette Parish Correctional Center is a prison, where Caton was held for two months without being charged and for another six after that, without bail, on the premise that he was a flight risk.

The government threatened to arrest Cathryn Caton and to file Racketeer Influenced and Corrupt Organization (RICO) charges against her, Greg, and their employees, on the basis, Caton says, “that AO labs was huge conspiracy to hurt the public with dangerous drugs.” They also threatened to arrest his employees as unindicted co-conspirators. (In fact, two of his Lumen Foods employees were subsequently arrested on drug charges. Caton doesn’t know if these were justified or not.)

The prospect of both Catons in prison carried the implicit threat of foster care for their seven-year-old son. Because of this, the Catons signed papers appointing Cathryn’s brother, in Texas, guardian for their son. They then sent their son to live with him for the entire fall school semester.

Caton was a flight risk because, the FDA contended, he had three passports and a pilot’s license and had flown as recently as the previous month (August 2003). They also claimed two guns he had in his home were for the purpose of harming federal agents. They made these claims in court, under oath, Caton says.

However, he didn’t have three passports — he had two, one of which had expired and was punched “VOID.” He didn’t have a pilot’s license — he had taken flying lessons, and the last time he had flown, according to the pilot’s log, was in August 2001, not 2003. The two guns were in his wife’s name, and they were purchased, he says, before Y2K, as a precaution. Nevertheless, when all the charges were added up, he potentially faced a long stretch in prison.

“They used perjurious statements to even raid my house to begin with,” Caton says. “They told a judge I was telling people to drink battery acid, and I’ve got the Department of Justice report to show that.” FDA agent John Armand was insistent about this in a meeting, Caton says, recounting their conversation.

“Yes, it’s battery acid. You know it’s battery acid. It’s sulfuric acid—it must be battery acid.”

“Would you like to see the MSDS sheet?” Caton asked.

“No, we don’t need to see that.”

“Would you like to see the skin sensitivity tests that were done in New Jersey, showing that this is completely noncaustic, noncorrosive?”

“You know that’s not what it is.”

Ultimately, the government offered Caton a plea bargain: one count of mail fraud, one count of introducing an unapproved new drug into interstate commerce, and forfeiture of all his commercial property.

The mail fraud charge was for selling the H3O. Despite the absurdity of the government’s claim that he was selling battery acid, why did they insist he plead to it? Caton has an answer for that. “It’s like the story of the guy who gets caught lying, and he looks you in the face, and he says to you, ‘That’s my story, and I’m sticking to it.’ ” This obtuse, maddening attitude of a bureaucrat caught in an error or an outright lie ultimately came to be something of a grim joke for the Catons, illustrating the groundlessness of the government’s case.

Caton recounts that the FDA contacted the manufacturer of the H3O, asking how to dispose of the battery acid. The owner of the company told them it wasn’t battery acid and asked how they got that idea — a question they didn’t answer. The owner subsequently received a call from the hazmat disposal company the FDA had retained, asking how to dispose of it. His reply was that the easiest way was probably to drink it.

The charge of introducing a new drug into interstate commerce was for shipping a bottle of Cansema Tonic III to Plantation, Florida. The recipient wasn’t specified, but the FDA happens to have a field office there.

The government’s pièce de résistance was its demand that Caton forfeit all his commercial property, plus $950,000. The rationale was that funds from Alpha Omega had been commingled with those of his other two companies and had “tainted” them. The FDA arrived at the amount from an analysis of his financial records, which they’d also seized — it was ostensibly what he’d defrauded customers out of. His assets were worth only about half what they demanded, so they agreed to settle — for everything he had.

Caton owned three buildings. He’d already had to sell a building in which he had $500,000 in equity, as well as the Preservx company (now called Global Preservatives) and its associated patent, for “pennies on the dollar” to pay his legal bills. Of the remaining three buildings, one was where Alpha Omega and Lumen Foods were located. Another was a storefront building. The third was a house, worth about $45,000, that he’d intended to sell to one of his assistants. Altogether, the buildings were worth about $400,000, although he owed about $180,000 on the mortgages. The FDA was going to let him keep his home and the processing equipment for Lumen Foods.

Caton wasn’t sure whether the government would sell the buildings or let him continue to lease from them. He estimated that if they sold, they might end up with $150,000 — not much for all the paper shuffling involved. However, it had emerged earlier that the FDA believed Caton had large sums of money stashed in offshore accounts. In fact, Caton has reliable information that the night before the raid, fourteen federal and local agents had a party at a local casino, celebrating what they thought would be a large haul the next day — which, he says, their departments would have shared in.

As it turned out, there were no offshore accounts. Caton is not a rich man, although he probably could have become one from his cancer remedies alone. He had fulfilled the three criteria he and his wife had established when they founded the company: his products worked, they were safe, and he charged reasonable prices. His customers’ many testimonials confirmed this. Ironically, his generosity had cost him dearly, because he’d had to scramble just to cover his legal expenses. On the other hand, of course, if he’d had more money, the FDA would have just taken it.

The belief that he had large offshore bank accounts may actually have been one of the factors motivating the FDA’s raid. Caton, who has become something of an unwilling expert on the subject (his eight months in jail gave him a lot of time to read), points out a quotation in a book by William Blum, Rogue State: A Guide to the World’s Only Superpower:

“The DEA, other federal and state agencies and police are seizing houses, boats, cars, airplanes, real estate, furnishings, bank accounts and other assets belonging to people suspected of involvement in drug trafficking, or belonging to their spouses, often without a conviction and whether or not the assets seized were tied to the alleged crime. ... The government agencies are selling these assets and using the proceeds for anything from patrol cars to parties. The expected value of forfeitures is at times a determining factor in the question of who to raid. Police are routinely planting drugs and falsifying police reports to establish probable cause for cash seizures. ... As of early 1999, there was $2.7 billion in the federal government’s ‘Asset Forfeiture Fund’ alone.” (p. 270–1)

Caton also points to a letter in the the April 15, 2004, Wall Street Journal that quotes former judge John Yoder, first head of the Justice Department's Asset Forfeiture Office in the Reagan administration:

“When I set up the Asset Forfeiture Office, I thought I could use my position to help protect citizens’ rights, and tried to insure that the U.S. Department of Justice went after big time drug dealers and big time criminals, rather than minor offenders and innocent property owners. Today, overzealous government agents and prosecutors will not think twice about seizing a yacht or a car if they find two marijuana cigarettes in it, regardless of where they came from. I am now ashamed of, and scared of the monster I helped to create.”

* * *

Reading through the thirty-eight pages of the eight-part plea agreement, one cannot but be struck by the monstrous fabrications, profound cynicism, and complete imperviousness to reason they display. The agreement claims Caton knowingly created “a scheme and artifice to defraud purchasers” and that “to facilitate the scheme and the artifice to defraud, the defendant purchased buildings at the two locations described.” So he didn’t just own the buildings — he purchased them deliberately to defraud people.

It’s hard to decide which is worse—that the government actually believes this or that they knew it was ridiculous and went ahead with it anyway. One thinks of Bob Dylan: “How many times can a man turn his head and pretend that he just doesn’t see?” Can one seriously believe, looking at the depth of information on Caton’s web site, the extent of the knowledge it reflects, the variety of products, the hundreds of testimonials, that he’s out to defraud people—unless one were already predisposed to view any alternative treatment as a fraud?

The potential prison time for the plea bargain was five years for the mail fraud and three years for introducing an unapproved new drug, but the government told him that realistically, he was looking at 41–47 months, less time served. Also, his cooperation with the FBI gave the judge considerable downward discretion. 

Cathryn Caton had sent out an appeal to Alpha Omega customers, asking for letters — testimonials, character references, requests for leniency — to present to the judge. She received a barrage of emails that, when printed out, yielded a two-inch-thick stack of letters.

The judge was already quite sympathetic. At the hearing where Caton entered his plea — after eight months in the parish jail — the judge pointed at him and said to the prosecutor, “Why is this man still in jail?” (Caton had previously appeared before two other judges.) The judge then released him on bond. As Caton put it, “This judge does not like prosecutorial misconduct, and this thing has got misconduct written all over it.”

Not content with destroying Caton’s livelihood and holding him in prison, the FDA proceeded to assail his reputation by giving the Associated Press a story that ran in Lake Charles and Lafayette papers. It gave the FDA’s version, quoting government officials and the attorney for the woman who had named Caton in her complaint but omitted him from her affidavit. The articles made him look only slightly less reprehensible than an axe murderer. Neither Caton nor his lawyer was contacted for their side.

At the sentencing hearing, the judge rejected the prosecution’s contention that Caton had intended to cause harm with his products and sentenced him to the minimum possible under the sentencing guidelines: 33 months, which he'll do in a minimum-security prison. With time served and good behavior he’ll do 20, of which the last six may be in a halfway house.

In all, Greg Caton estimates, the FDA took $250,000 worth of materials and $400,000 worth of buildings. This doesn’t include what he lost in the distress sale of Preservx and the one building he sold, his legal fees — which amounted to $50,000 for the criminal charges alone — or the ongoing revenue from Preservx and Alpha Omega.

After Caton was arrested, his wife had T-shirts made up. The front says, “I survived an FDA raid on September 17, 2003.” The back is like a rock band’s tour schedule, but instead of concert dates, it says “Other FDA survivors,” then “In remembrance of Dr. Royal Rife, Harry Hoxsey and all others that have contributed to alternative healing methods and for the freedom of choice.” This is followed by the names of eight victims of FDA raids, the last being Greg Caton’s. At the bottom is a picture of Uncle Sam pointing outward, with the caption “Coming soon to a city near you.”

“One of the sacred principles of American life is that private property is respected,” Caton says. “I don’t even want citizenship in a country that’s capable of doing this. I’m a manufacturer. I have equipment, I have inventory — raw goods, finished goods, goods in process, goods already prepared to ship that are on the bay door waiting to go out. You can’t run a business if the principle of private property isn’t respected.

“If you’re an herbalist and you do what we do for a living, and you have extensive knowledge and you’re very good at what you do, if at any given time they can just come in and take your property, real property, take equipment, take inventory, take goods — just take it all, like they did in my case — you can’t operate in that kind of an environment.

“We’ve reached a point in our journey on the road to becoming a police state where federal agents can get up on the stand, they can raise their hand, they’re under oath, they can lie in the most egregious ways, and I guess judges aren’t going to do anything about it. I brought this up to two different defense attorneys, and it was like, blasé — looking at me as if, ‘Are you naïve? So what? They lied — so what? Do you never get out of the house? Don’t you know what’s going on?’ That was the real mindblower in this whole situation: there’s nothing special about me or my case. This goes on all the time.”

While Greg Caton was in jail, FDA agent John Armand told one of Caton’s lawyers that he’d been getting calls from all over the world, from people who had used Alpha Omega’s products, protesting what had happened. Cathryn Caton had been getting calls too, from customers crying, saying nothing else worked and that it was a matter of life and death. She referred them to the FDA.

* * *

Although asset forfeiture may have been on the FDA’s mind when they went after Caton, they’ve been raiding proponents of alternative remedies for decades — since long before asset forfeiture was an option or the term “alternative remedies” even existed. The FDA, in fact, has a long and distinguished history of ruthlessly exterminating anything that competes with conventional treatment, particularly for cancer.

It’s been observed that the FDA is heavily influenced by the medical and pharmaceutical industries. Its favoritism had become so flagrant that, as James Carter, M.D., points out in Racketeering in Medicine, “In June, 1990, Marvin Seife, the former head of the FDA’s generic drug division, was the fifth FDA official to be indicted by a federal grand jury on charges of perjury. ... Four of Seife’s former employees at FDA have already been convicted on corruption and racketeering charges. Five industry executives, three companies and one consultant have been convicted of similar charges.” (p. 165)

Conflicts of interest are still rampant, as a September 25, 2000, article in USA Today points out: “More than half of the experts hired to advise the government on the safety and effectiveness of medicine have financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions.”

And as Shannon Brownlee reports in the April 2004 Washingtonian, “More than 60 percent of clinical studies — those involving human subjects — are now funded not by the federal government, but by the pharmaceutical and biotech industries. That means that the studies published in scientific journals like Nature and The New England Journal of Medicine ... are increasingly likely to be designed, controlled, and sometimes even ghost-written by marketing departments, rather than academic scientists.” 

Considering the FDA’s enforcement efforts, or lack thereof, toward pharmaceutical manufacturers, its insistence on a mail fraud charge for Caton’s H3O seems more than a little hypocritical, A study in the April 15, 1998, Journal of the American Medical Association (JAMA) reports that 76,000–137,000 people die each year from adverse drug reactions.

Despite this, according to the February 2003 Consumer Reports, the number of warning letters the FDA sends to drug manufacturers “about false or misleading drug ads has dropped precipitously, from more than 100 per year in the late 1990s to just 24 as of November 2002.” A drug company’s misleading ad campaign may have run its course before the FDA gets around to sending a warning letter, if it does at all.

The listing of warning letters on the FDA’s web site shows that the downward trend has continued to the present. (The Consumer Reports article also details a number of other questionable practices by the industry.) Even drugs with proven harmful or fatal effects are merely taken off the market. The manufacturer is not raided, its assets are not seized, and its officers do not do time.

Like the pharmaceutical industry, the medical establishment is not blameless in attempting to suppress alternative remedies. In 1976, in what came to be known as the Wilk case, several Chicago-area chiropractors sued the American Medical Association (AMA), which they claimed had conspired to destroy their profession. The case went on for fifteen years, in the course of which nearly a million pages of documents, many from the AMA’s files, were disclosed.

As author John Robbins put it, “It was revealed quite clearly that, for many years, the AMA had deliberately and systematically conspired to destroy not only chiropractic, but midwifery, homeopathy, naturopathy, and herbalism. The whole collection of what we call wholistic and alternative medicine had been the AMA’s target for destruction.” The case ultimately went to the U.S. Supreme Court, and the chiropractors won.

The medical and pharmaceutical industries’ interest in disparaging alternative treatment is understandable. Several studies published in medical journals point out that the number of visits per year to alternative practitioners now exceeds visits to conventional physicians, with most people paying out of their own pockets. This has been going on since at least 1990 and is due to more people “seeking alternative therapies, rather than increased visits per patient,” according to a 1998 study in JAMA. Clearly, all these people can’t be dupes of scam artists.

* * *

Considering that half of American men and a third of American women will come down with cancer, the question must be asked: whom is the FDA “protecting”? The agency has effectively become the enforcement branch of the medical and pharmaceutical industries, which want to preserve the status quo. The pharmaceutical industry can’t make any money on natural remedies, and the doctors don’t want to lose the vast amounts of funding poured into cancer research.

It’s been said that those with serious illnesses are vulnerable to fraud, and some may be — although they’re equally vulnerable to a doctor’s pitch for conventional treatment that doesn’t work. But unlike in decades past, virtually everyone now has access to a wide variety of health information on the Internet — and they’re using it.

A survey in 2000 by the Pew Internet & American Life Project shows that “fifty-two million American adults, or 55% of those with Internet access, have used the Web to get health or medical information.” Of these, 91% “have looked for material related to a physical illness.” And “for the 21 million health seekers who say they were swayed by what they read online the last time they sought health information ... 70% said the Web information influenced their decision about how to treat an illness or condition.”

People are looking elsewhere because they’re realizing that the Western approach is expensive, debilitating, and often ineffective — that it treats the symptoms rather than the cause. We’re in the middle of a changing paradigm — changing from the concept of attacking disease to one of eliminating it by restoring balance.

Surely we, as adults, have the right to choose the type of healthcare treatment available to us without the government unilaterally eliminating our options. Isn’t it time for the FDA to heed what the patient at one alternative cancer clinic said to them during a raid? “We’re all adults here, making free-will choices. Why don’t you get out of here and leave us alone?”

Aside from restricting our healthcare choices, what justifies the FDA’s gestapo/KGB tactics in smashing, intimidating, demoralizing, and bankrupting its targets, even before a trial to determine their guilt or innocence? What justifies seizing their assets, impounding their computers and business records, confiscating their personal papers and effects, destroying their products and ingredients, and holding them in prison for extended periods?

Very few people can do what Caton and others like him have done. It takes tremendous initiative to come up with a product that works, make it available commercially, and assume the risks of being put out of business and perhaps imprisoned by the FDA.

Perhaps most important, Caton resisted the temptation to get rich on other people’s suffering, which can’t be said of the pharmaceutical industry. He could have made much more money and put enough away to cover his eventual ruinous legal expenses — but he didn’t. Shouldn’t we be encouraging and rewarding people like this rather than persecuting them and destroying their lives?

Update (2008): Greg Caton served his time, then moved with his family to South America, where he reopened Alpha Omega Laboratories.