Prometa

Prometa is an ineffective treatment promoted for methamphetamine addiction, although it had also been claimed to be effective for dependence on alcohol or cocaine.[1] It was marketed as GABASYNC. The treatment, based loosely on the research of Spanish psychologist Juan Jose Legarda, involved a combination of three medications (gabapentin, flumazenil and hydroxyzine) as well as therapy. While the individual drugs had been approved by the FDA, their off-label use for addiction treatment has not.[2]. Prometa was marketed by Hythiam, Inc. which is owned by Terren Peizer, a former junk bond trader. [3] Hythiam has sought to patent the protocol and charges up to $15,000 per patient to license its use (of which half goes to the prescribing physician, and half to Hythiam).[4] Lower rates are offered to the criminal justice system, where it has been used in several drug court pilot programs.[5]

In November 2011, the results of a double-blind, placebo-controlled study (financed by Hythiam and carried out at UCLA) were published in the peer-reviewed journal Addiction. It concluded that Prometa is ineffective: "The PROMETA protocol, consisting of flumazenil, gabapentin and hydroxyzine, appears to be no more effective than placebo in reducing methamphetamine use, retaining patients in treatment or reducing methamphetamine craving." [6]

Treatment steps

For alcohol dependence, the treatment consists of flumazenil (administered intravenously), hydroxyzine, and gabapentin. The treatment is similar for stimulant dependence, with additional flumazenil administrations. The dosing regimen of the drug combination is discussed in Urschel’s recently published study. The initial intravenous administrations are followed up by orally prescribed medications and behavioral treatment.[7]

Controlled studies

Preliminary evidence that a regimen combining hydroxyzine, flumazenil and gabapentin - i.e. the active pharmacological components of Prometa - can help decrease methamphetamine cravings and use was first published in October 2007 following a relatively small, open-label trial by Dr. Harold C. Urschel. The study, funded by Hythiam, was published in the Mayo Clinic Proceedings, a peer reviewed medical journal.[7]

60 Minutes reported that Dr. Urschel's addiction clinic sold the Prometa treatment. However Urschel denied this was a conflict of interest.[1]

Dr. Urschel has also completed a double-blind, placebo controlled study of Prometa's active ingredients, where 68 patients were randomized to active and 67 patients to placebo treatment for 30 days. The study reported a decrease in both cravings and methamphetamine use following the initial treatment and throughout the 30 days treatment period.[8]

The effects of the flumazenil/gabapentin combination in the treatment of alcohol dependence are less clear. In a randomized, placebo-controlled trial alcohol-dependent subjects taking flumazenil/gabapentin had more abstinent days and time to first heavy drinking if they had high alcohol withdrawal symptoms prior to treatment, whereas the patients with low withdrawal symptoms actually did worse with active treatment.[9]

Pilot programs

A Hythiam press release in 2004 announced that a center in Covington, Louisiana, would offer the treatment that was to become known as Prometa in that court's drug program. However, the program was never implemented, and the judge there said he was uncomfortable that the evidence for it was not as strong as the company's marketing. As a result, the first Prometa pilot took place in Gary, Indiana, beginning in November 2005. According to Hythiam the trial was a success and had been adopted, but, according to the Tahoma audit, it was ended early and not adopted. [10][11] Karen Freeman-Wilson, who had been promoting the Prometa trial as the CEO of National Association of Drug Court Professionals, later joined the Board of Directors at Hythiam.[12]

Another trial in Fulton County, Georgia, ended early because it was not deemed effective; one report mentioned physician misconduct, but court officials would not comment about the issue.[13][11]

Pierce County, Washington, initiated a 40-person pilot program in 2006 through a nonprofit treatment center serving the county's drug court, and officials reported very promising results.[14] With this they were able to get $900,000 for Prometa funding in the state and county budgets for 2007, including a University of Washington study to evaluate the treatment. However, it was subsequently revealed that county executive John Ladenburg, state legislator Dennis Flannigan, and officials at the treatment center had bought Hythiam stock.[1][15] A county audit also questioned the effectiveness of the program, in part because auditors took a different approach than the treatment center in determining whether Prometa was successful.[16][17][11]

These revelations led the Pierce County Council to suspend its funding for the program in October 2007.[18] An unspent $175,000, along with $400,000 Ladenburg had requested for 2008, were instead set aside with the proviso that they could be used for "evidence-based programs that are directed towards breaking the cycle of drug addiction".[19] Ladenburg and Flannigan also had to amend their state financial disclosure forms, although Ladenburg reported he had sold his stock at a loss and insisted it did not influence his actions.[20] The news from Pierce County, along with a 60 Minutes investigation of Prometa that aired in December, battered Hythiam's stock, as it fell in value nearly two-thirds by the end of the year.[13] However, at the same time the city council in nearby Federal Way, Washington, approved a small $20,000 Prometa trial at the suggestion of a city council member whose employee, one of Prometa's successes, had been treated in Pierce County and featured in the 60 Minutes report.[21]

Also in 2007, Jerry Madden, chair of the Texas House Corrections Committee, secured $2 million of funding over two years in the state budget for Prometa treatment programs. In contrast with officials in Washington, Madden said he had no financial ties to Hythiam. In support of the budget request he cited a 20-person pilot paid for by Hythiam in Collin County, where the local judge, Charles Sandoval, reported a "spectacular" success rate (even though, when asked, stated that he hadn't kept any records). [22][23] Other courts in the state were more skeptical about the lack of clinical research supporting Prometa, however, and only four other counties requested funding. About half of the amount budgeted for the initial year was spent.[24]

Despite a ban on marketing of off-label drug use, Hythiam started a national advertising campaign in 2006, utilizing billboards, radio spots, as well as Internet ads and paid search results. [25][26] In one of the billboard ads the image of Chris Farley (who had died of a drug overdose) was used, which caused significant controversy. [27][28] Ads with other dead celebrities were planned (according to Hythiam's CEO, Terren Peizer), but it seems none were actually published. [29]

Actress Lindsay Lohan was connected to Prometa as one of her rehab efforts during 2007, when Star Magazine reported that she was being treated by Dr. Matthew Torrington, director of the Prometa Center in Santa Monica.[30] Prometa was also featured in an episode of the MTV series True Life, in which recovering methamphetamine addict "Dustin" allowed the network to film his treatment with Prometa, as well as his life before and after he quit using the drug.[31]

References
  1. "Prescription For Addiction". 60 Minutes. CBS News. December 9, 2007. Retrieved 2008-08-22.
  2. Prometa Founder's Spotty Background Explored, November 3, 2006, http://www.drugfree.org/join-together/prometa-founders-spotty-background-explored/ Archived 2015-09-23 at the Wayback Machine
  3. Prescription For Addiction, 60 Minutes' Scott Pelley Reports On A New Addiction Treatment, Dec. 07, 2007, http://www.cbsnews.com/news/prescription-for-addiction/
  4. "Prometa under fire in Washington drug court program". Alcoholism & Drug Abuse Weekly. January 21, 2008.
  5. Roan, Shari (October 9, 2006). "Addiction treatment, novel but unproved; Prometa's promoters point to anecdotal success. But critics want to see hard numbers". Los Angeles Times. p. F1.
  6. Ling, W.; Shoptaw, S.; Hillhouse, M.; Bholat, M. A. (November 2011). "Double-blind placebo-controlled evaluation of the PROMETA™ protocol for methamphetamine dependence". Addiction. 107: 361–369. doi:10.1111/j.1360-0443.2011.03619.x. PMC 4122522. PMID 22082089.
  7. Urschel 3rd, Harold C; Hanselka, Larry L; Gromov, Irin; White, Lenae; Baron, Michael. "Open-label study of a proprietary treatment program targeting type A gamma-aminobutyric acid receptor dysregulation in methamphetamine dependence". Mayo Clin Proc. PMID 17908523.
  8. Urschel, HC; Hanselka, LL; Baron, M (November 2009). "A controlled trial of flumazenil and gabapentin for initial treatment of methylamphetamine dependence". J. Psychopharmacol. (Oxford). 25: 254–62. doi:10.1177/0269881109349837. PMID 19939864.
  9. Anton, RF; Myrick, H; Baros, AM; et al. (August 2009). "Efficacy of a combination of flumazenil and gabapentin in the treatment of alcohol dependence: relationship to alcohol withdrawal symptoms". J Clin Psychopharmacol. 29: 334–42. doi:10.1097/JCP.0b013e3181aba6a4. PMID 19593171.
  10. "PROMETA Protocol Adopted by Gary, Indiana". businesswire.com.
  11. "Effectiveness of Prometa Treatment Protocol in Pierce County Drug Courts". Pierce County Performance Audit Committee.
  12. "Hythiam, Inc. Appoints Past Indiana State Attorney General and Former Head of National Drug Court Institute to Board of Directors". biospace.com.
  13. Robinson, Sean (December 23, 2007). "Data show mixed value of Prometa". The News Tribune.
  14. Clarridge, Christine (July 9, 2006). "Pilot program helps ease drug addictions". Seattle Times. Retrieved 2008-08-25.
  15. Otto, M. Alexander (October 24, 2007). "Local officials owned stock in company". The News Tribune. p. 106.
  16. "Effectiveness of Prometa Treatment Protocol in Pierce County Drug Courts". Pierce County Performance Audit Committee.
  17. Robinson, Sean (November 11, 2007). "Success or failure? Probing Prometa" (PDF). The News Tribune.
  18. Otto, M. Alexander (October 24, 2007). "Council cuts off drug program" (PDF). The News Tribune.
  19. Wickert, David (November 21, 2007). "Council rejects Prometa funding request". The News Tribune.
  20. Wickert, David (November 6, 2007). "Politicians revise stock disclosures". The News Tribune.
  21. Maynard, Steve (November 22, 2007). "In Federal Way, Prometa gets council support". The News Tribune.
  22. "Junk Bonds to Junk Science? Drug Treatment Program Questioned". prisonlegalnews.org.
  23. "The Worst Judge in Dallas County". dmagazine.com.
  24. Ramshaw, Emily (January 20, 2008). "Texas' Prometa program for treating meth addicts draws skeptics". Dallas Morning News.
  25. "Actor who died of overdose stars in addiction treatment ads". adage.com.
  26. "A warning sign on Sunset". Los Angeles Times.
  27. "Addiction treatment's effectiveness argued". The Seattle Times.
  28. "Billboard in Los Angeles". jugularnyc.com.
  29. "Chris Farley Lives on Billboard". eonline.com.
  30. "Lindsay's Shocking Drug Therapy". Star Magazine. October 24, 2007. Retrieved 2008-08-22.
  31. "I'm Going to Rehab" (video). True Life. MTV. December 6, 2007. Retrieved 2007-12-10.
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