Farley's Ghost Stumps for Untested Drug Treatment Protocol

By Ellen Komp, 4/7/06

Chris Farley is featured in a campaign to advertise Prometa, an untested protocol to treat drug addiction that is being pushed by profit-mongering ex-government officials to consumers, health care programs and drug courts.

Remember Chris Farley's depiction of the motivational speaker who LIVED IN A VAN DOWN BY THE RIVER in the Saturday Night Live skit that had David Spade and Christina Applegate playing teens caught with pot whose parents brought in Farley to cure them? "You want to be a writer? Well, I hear you're using your paper to ROLL REEFERS," Farley bellowed in a memorable performance that had the rest of the cast just trying to keep a straight face. The kids swear off pot only to get rid of the guy, who is locked out of the house by their parents.

Farley is back in an anti-drug role, on a huge billboard on Sunset Boulevard in Los Angeles, posthumously advertising a drug treatment protocol called Prometa from Hythiam, Inc. Farley died from a drug overdose eight years ago at the age of 33. The campaign, directed at consumers with addictions to alcohol, cocaine or methamphetamines, will include outdoor billboards, signage in Burbank airport, radio advertising, online marketing, a new campaign website and an aggressive public relations campaign. Hythiam paid Farley's estate $25,000 for the right to use the image and is reportedly negotiating with other dead celebrities' families.

But would Farley have endorsed Prometa if he knew that it is nearly untested, despite other aggressive campaigns by Hythiam get its product placed with health care providers and drug courts across the country? The Prometa protocol uses a combination of drugs not approved by the FDA for use in addiction treatment, combined with nutritional supplements and "psychosocial therapy." Hythiam holds no patent on the drugs; instead, it has applied for patents on its methodology but will not seek FDA approval for the treatment.

Sanjay Sabnani, Senior Vice President of Strategic Development for Hythiam in Los Angeles, said the company would not release the names of the drugs used in the protocol because it would be "irresponsible" of the company to, in effect, advertise an off-label use of a drug. He said the drugs worked on the alpha-4 subunits of GABA receptors in the brain, the ones on which benzodiazepines like Valium work, which seem to get stuck in the "on" position during conditions like PMS and drug withdrawal, causing anxiety and agitation. An upcoming report of a Texas study using imaging technology to verify the action on receptors will soon be published, he said.

A search of the US patent applications online reveals Hythiam has applied for patents for protocols using selective chloride channel modulators, such as flumazenil, a Roche product used to counter the effects of benzodiazepines. Sabnani would not confirm that this was one of the drugs used.

Flumazenil can cause fear and panic attacks in patients with a history of panic attacks, according to Roche literature, which says deaths and severe adverse reactions including heart attacks have occurred in clinical settings. It should be used with caution in patients with alcohol and other drug dependencies, Roche says, because that population often has addictions to benzodiazepines too. Hythiam was founded in 2003 by Terren Peizer. According to the Los Angeles Times, Peizer is a former junk bond trader who has been involved with several medical firms since he was granted immunity for his testimony against Michael Milken. The rest of the Hythiam board is largely from the financial sector and includes Dr. Andrea Grubb Barthwell, the former Deputy Director for Demand Reduction of the White House Office of National Drug Control Policy (ONDCP). Barthwell joins other former drug warriors in cashing in on the drug treatment and drug testing industries.

Last week, Dr. Raymond Johnson of Ft. Meyers, FL reported preliminary findings in a clinical study of 52 patients who were treated with Prometa for alcohol and stimulant dependence in a special session of the Florida Society of Addiction Medicine's (FSAM) Annual Conference on Addictions. Johnson reported a 92% success rate in his patients, most of whom had failed in other treatment programs. To measure Prometa's success, patients were asked to self-report their use of substances, and if use was suspected, a counselor would verify abstinence by asking the patient to voluntarily supply a urine sample.

Dr. Barthwell gave the keynote address at the conference, and Dr. David E. Smith, Hythiam's Senior Vice President of Medical Affairs, also presented there. Hythiam's shares on NASDAQ jumped by some 20% to just under $9 a share when the news of the study was announced. HYTM is currently trading at $8.56, down $0.48 or 5.31% from the previous close, on 40 million shares, after an article appeared saying the Prometa protocol employed an anesthetic used for opiate detoxification. Hythiam denied the charge.

Last July, Hythiam named Michael E. Green its Director of Business Development, overseeing eight site managers. Green came from Reckitt Benckiser Pharmaceutical, where he was a clinical liaison during the 2003 launch of SUBOXONE® and SUBUTEX®, treatments for opiate dependence made from Buprenorphine and naloxone, drugs which substitute for opiods and block their receptors.

Meanwhile, it's market first, test later in the Hythiam world. On March 14, the company announced that PROMETA protocols have successfully passed review by the New Technology Committee of CompCare (Tampa, Florida), and are now approved for reimbursement. The press release stated, "Nearly all of CompCare's approximately 800,000 behavioral health managed lives have some level of insurance benefit to treat substance dependency."

On March 8^th Hythiam announced the Pierce County Alliance in the State of Washington will conduct a pilot program to determine Prometa's effectiveness as a medical treatment for methamphetamine and cocaine dependency, and its effect on reducing recidivism among drug court offenders. Funding for this 50-person pilot will be provided through federal, state, and county sources. Last July, Arlandis Rush, formerly with the National Association of Drug Court Professionals (NADCP), was named Vice President of Government Programs at Hythiam.

In January, Hythiam awarded the Gay and Lesbian Medical Association (GLMA) an unrestricted educational grant of approximately $320,000. to examine methamphetamine use in the gay community and treatment options, and to make recommendations about how health care providers can get meth-addicted patients into treatment.

On its recent program "The Meth Epidemic," PBS's Frontline interviewed Gene Haislip, formerly #3 man at the DEA, who brought Quaalude use under control by negotiating with foreign producers of the raw ingredients used to make the drug. Haislip wanted to do the same thing with ephedrine, meth's main ingredient, until higher ups in the Reagan administration made it clear he needed to acquiesce to Big Pharma's demands. Since ephedrine is also used in cold medications, the pharmaceutical industry resisted regulation and Congress still hasn't caught up with illegal labs.

There are now an estimated 1.5 million people hooked on meth in the US, and in some parts of the country, 60-80% of prisoners are meth addicts. Now the same government that assured the epidemic would happen is lined up to profit from it, by practically forcing people into using an untested and possibly dangerous treatment. Prometa may be a good option, but let's let the FDA test it before the investors line up to cash in on other people's tragedies.

Ellen Komp manages the website www.veryimportantpotheads.com

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