By CHRISTOPHER BYRON

April 10, 2006 -- FLAWS, MURKY PAST CLOUD FARLEY-HYPED TREATMENT PLAN
SHOULD the Food and Drug Administration allow an untested and potentially lethal prescription drug potion concocted by a Spanish psychologist with a checkered past to be marketed to U.S. consumers by a one-time Alaskan trucking company run by a Wall Streeter tied to a string of failed penny-stock promotions?

Oh, and one other thing: Should it make any difference that the company in question, which goes by the name Hythiam Inc., has been filing annual fanny-covering disclaimers with the Securities and Exchange Commission from the moment of its birth as a drug company three years ago, warning investors that its entire business plan rests on an approach to prescription drug marketing that may be in violation of federal law and the FDA's own regulations?

So far as the bureaucrats of the FDA are concerned, there's apparently nothing to worry about, which is why Hythiam and its CEO, Terren Peizer, have been all over the news promoting what the company claims to be a revolutionary new treatment for alcohol and cocaine abusers.

This new treatment in fact consists of a cocktail of nutritional supplements along with at least one, and possibly two or more, prescription drugs: something known as Flumazenil and a separate drug known as Gabapentin.

Neither drug has ever been approved by the FDA for the treatment of alcohol or cocaine dependency - let alone when mixed together in combination with vitamins and whatnot.

But Hythiam is using them for exactly that purpose by exploiting a regulatory loophole known as "off-label" usage.

As the law now stands, physicians are allowed, as they always have been, to use FDA-approved drugs to treat conditions the drugs themselves were never tested or approved for in the first place.

Yet as much as they've sought the same freedom that is enjoyed by doctors, the pharmaceuticals companies are still prevented from drumming up sales for their FDA-licensed drugs by advertising and marketing them to the public for uses the regulator hasn't approved.

And they're also obviously barred from marketing drugs they didn't develop - and that are owned by rival drug makers.

But that is exactly what Hythiam is doing with its cocktails of nutritional supplements and prescription drug chasers.

The company is only now beginning clinical trials for its potions, and the results are not expected until 2008.

Yet Hythiam has already begun promoting the treatment, dubbed its "Prometa protocols." The campaign began last week with an attention-grabbing ad blitz featuring a posthumous endorsement from comedian Chris Farley, who died of a drug overdose in 1997.

THAT alone has addic tion experts railing at Hythiam's unseemly rush to market. Said Dr. Herbert D. Kleber, who heads Columbia University's Division of Substance Abuse: "Until the results of controlled studies are available and published in peer-reviewed literature, there is nothing that a physician has to go on, other than the word of the promoters that the treatment is safe."

There's certainly reason to wonder about the background and credentials claimed for the man who thought up the whole Chinese menu-type approach to the treatment of substance abuse that Hythiam is now using.

Spanish-born Juan Jose Legarda, 51, is listed in Hythiam filings as holding a Ph.D. from the University of London, but his specialty is not provided. A 1995 article in a Gibraltar newspaper said he founded the Center For Investigation and Treatment of Addictions in Seville (CITA), where he developed a drug-based treatment for heroin addiction.

A story from around the same time in a Jerusalem newspaper described Legarda as being married to the sister of a man named Waismann, who was identified as heading up another clinic under the CITA moniker in Israel. These and other stories presented CITA as promoting an exciting-sounding but untested and controversial approach to the treatment of drug addiction based on proprietary formulas of various concoctions.

An early 1996 study in the U.S. by the National Institute On Drug Abuse said the CITA procedure, which was later in use at Metropolitan Hospital on New York City's East Side - though it had not been approved by the FDA - was without medical or scientific justification and put patients at risk of serious side effects and even death.

A 1998 article in the Lancet, Britain's leading medical journal, accused Legarda of falsifying data regarding CITA cure rates, of publicity grandstanding, and of selling franchise licenses for its treatments. Later, the Lancet published a letter from Legarda saying none of the charges was true.

By that time, Legarda's operation had spread to the U.S. and he had signed a contract to run one of his treatment clinics at Metropolitan Hospital. Its secret methodology: Anesthetizing heroin addicts, then pumping them full of prescription drug cocktails.

Soon thereafter, Legarda sold the business to a group of European investors.

In 2003, an ex-junk bond salesman named Terren Peizer became involved. Peizer had escaped prosecution following the collapse of Drexel Burnham & Co. by testifying for the government against his boss, Michael Milken.

BUT the taint of having been a government snitch had limited Peizer's prospects on Wall Street, and he had wound up scouting for opportunities for himself in the small cap and micro-cap byways of the market.

In early 2003, Peizer spotted what seemed to be a promising one and lent $300,000 to the CITA operation that Legarda had previously sold and that had by now been sold yet again - first to two California businessmen who had thereafter folded it into the shell of a defunct penny-stock company in the race-horse-breeding business, renaming the company Xino Corp.

When Xino defaulted on Peizer's loan, Peizer foreclosed, thereby acquiring the rights to Legarda's secret sauce for heroin addicts. Simultaneously, Peizer signed a separate deal with Legarda directly to take over his treatments for alcohol and cocaine as well.

These two sets of assets he then folded into a failed penny-stock shell company in the trucking business, and renamed it Hythiam Inc., listing the combined value of the treatments at $2.7 million.

Since then, filings show no outlays for research and development until last year, when $2.6 million was spent on gearing up for some clinical trials. There is also an item that keeps growing larger every year: outlays lumped together in a catchall category called "Other." By last year, these non-enumerated outlays had swelled to $13.2 million.

What was the money spent on? It's impossible to know, which seems to be the whole idea, and when the question was put to the company, no response was forthcoming by deadline.

Nor did anyone at the FDA seem interested in discussing why we need marketing regulations when a company like Hythiam can promote prescription-drug potions without really knowing whether the concoctions are safe or not. What's more, no one at the FDA seemed to either notice or care. That's your tax dollars at work, folks.

cbyron@nypost.com