Gabasync

Last updated

Gabasync 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 PROMETA. 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] Gabasync was marketed by Hythiam, Inc. which is owned by Terren Peizer, a former junk bond salesman who has since been indicted for securities fraud relative to another company. [3] [4] 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). [5] Lower rates are offered to the criminal justice system, where it has been used in several drug court pilot programs. [6]

Contents

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 Gabasync 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." [7]

History

In 2004 Terren Peizer, a former junk bond salesman, founded Hythiam Inc., a tiny pharmaceutical company, from which in 2006 when he was majority shareholder he received $1.3 million in compensation. [8] [9] [10] The firm bought the rights to an ineffective addiction treatment, and marketed it. [11] Despite the fact that no placebo-controlled or double-blind study or peer-reviewed publication of its "Prometa" (the marketing name for Gabasync) approach had been undertaken, and although no FDA approval had been obtained, Hythiam advertised the "innovative, medically based treatment" (which could cost $15,000 per patient) and franchised doctors to use Prometa, in exchange for a per-patient fee. [12] [9] Barrons , in a November 2005 article entitled "Curb Your Cravings For This Stock", wrote "If the venture works out for patients and the investing public, it'll be a rare success for Peizer, who's promoted a series of disappointing small-cap medical or technology stocks ... since his days at Drexel". [9] Peizer said: "Hythiam is my biggest triumph. If it's the only thing I did, then my life would have been a tremendous success." [13]

Journalist Scott Pelley said to Peizer in 2007: "Depending and who you talk to, you're either a revolutionary or a snake oil salesman." [12] 60 Minutes , NBC News , and The Dallas Morning News criticized Peizer after the company bypassed clinical studies and government approval when bringing to market Prometa; the addiction drug proved to be completely ineffective. [14] [15] [1] [16] Journalist Adam Feuerstein opined: "most of what Peizer says is dubious-sounding hype". [17] In June 2008, Hythiam had generated a net loss each year for 5 straight years, and while its stock had traded at $61.26 a share in 2007, it traded at $0.18 per share three years later. [18] [19] According to independent investment research firm Morningstar: "Over the long haul, this company has posted some of its industry's worst returns on assets." [18]

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. [20]

Controlled studies

Preliminary evidence that a regimen combining hydroxyzine, flumazenil and gabapentin - i.e. the active pharmacological components of Gabasync - 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. [20]

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

Dr. Urschel has also completed a double-blind, placebo controlled study of Gabasync'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. [21]

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. [22]

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 Gabasync 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 Gabasync 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. [23] [24] Karen Freeman-Wilson, who had been promoting the Gabasync trial as the CEO of National Association of Drug Court Professionals, later joined the Board of Directors at Hythiam. [25]

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. [26] [24]

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. [27] With this they were able to get $900,000 for Gabasync 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] [28] 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 Gabasync was successful. [24] [29]

These revelations led the Pierce County Council to suspend its funding for the program in October 2007. [30] 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". [31] 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. [32] The news from Pierce County, along with a 60 Minutes investigation of Gabasync that aired in December, battered Hythiam's stock, as it fell in value nearly two-thirds by the end of the year. [26] However, at the same time the city council in nearby Federal Way, Washington, approved a small $20,000 Gabasync trial at the suggestion of a city council member whose employee, one of Gabasync's successes, had been treated in Pierce County and featured in the 60 Minutes report. [33]

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 Gabasync 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). [34] [35] Other courts in the state were more skeptical about the lack of clinical research supporting Gabasync, however, and only four other counties requested funding. About half of the amount budgeted for the initial year was spent. [16]

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. [36] [37] In one of the billboard ads the image of Chris Farley (who had died of a drug overdose) was used, which caused significant controversy. [38] [39] Ads with other dead celebrities were planned (according to Hythiam's CEO, Terren Peizer, who has since been indicted for securities fraud relative to another company), but it seems none were actually published. [40] [3]

Actress Lindsay Lohan was connected to Gabasync as one of her rehab efforts during 2007, when Star Magazine reported that she was being treated by Dr. Matthew Torrington, director of the Gabasync Center in Santa Monica. [41] Gabasync 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 Gabasync, as well as his life before and after he quit using the drug. [42]

Related Research Articles

Drug rehabilitation is the process of medical or psychotherapeutic treatment for dependency on psychoactive substances such as alcohol, prescription drugs, and street drugs such as cannabis, cocaine, heroin or amphetamines. The general intent is to enable the patient to confront substance dependence, if present, and stop substance misuse to avoid the psychological, legal, financial, social, and physical consequences that can be caused.

<span class="mw-page-title-main">Gabapentin</span> Anticonvulsant medication for seizures and pain

Gabapentin, sold under the brand name Neurontin among others, is an anticonvulsant medication primarily used to treat partial seizures and neuropathic pain. It is commonly used medication for the treatment of neuropathic pain caused by diabetic neuropathy, postherpetic neuralgia, and central pain. It is moderately effective: about 30–40% of those given gabapentin for diabetic neuropathy or postherpetic neuralgia have a meaningful benefit.

<span class="mw-page-title-main">Opioid use disorder</span> Medical condition

Opioid use disorder (OUD) is a substance use disorder characterized by cravings for opioids, continued use despite physical and/or psychological deterioration, increased tolerance with use, and withdrawal symptoms after discontinuing opioids. Opioid withdrawal symptoms include nausea, muscle aches, diarrhea, trouble sleeping, agitation, and a low mood. Addiction and dependence are important components of OUD.

<span class="mw-page-title-main">Flumazenil</span> Chemical compound

Flumazenil is a selective GABAA receptor antagonist administered via injection, otic insertion, or intranasally. Therapeutically, it acts as both an antagonist and antidote to benzodiazepines, through competitive inhibition.

<span class="mw-page-title-main">Naltrexone</span> Medication

Naltrexone, sold under the brand names Revia and Vivitrol among others, is a medication primarily used to manage alcohol use or opioid use disorder by reducing cravings and feelings of euphoria associated with substance use disorder. It has also been found effective in the treatment of other addictions and may be used for them off-label. An opioid-dependent person should not receive naltrexone before detoxification. It is taken by mouth or by injection into a muscle. Effects begin within 30 minutes,though a decreased desire for opioids may take a few weeks to occur.

Substance dependence, also known as drug dependence, is a biopsychological situation whereby an individual's functionality is dependent on the necessitated re-consumption of a psychoactive substance because of an adaptive state that has developed within the individual from psychoactive substance consumption that results in the experience of withdrawal and that necessitates the re-consumption of the drug. A drug addiction, a distinct concept from substance dependence, is defined as compulsive, out-of-control drug use, despite negative consequences. An addictive drug is a drug which is both rewarding and reinforcing. ΔFosB, a gene transcription factor, is now known to be a critical component and common factor in the development of virtually all forms of behavioral and drug addictions, but not dependence.

NicVAX is an experimental conjugate vaccine intended to reduce or eliminate physical dependence to nicotine. According to the U.S. National Institute of Drug Abuse, NicVAX can potentially be used to inoculate against nicotine addiction. This proprietary vaccine is being developed by Nabi Biopharmaceuticals of Rockville, MD. with the support from the U.S. National Institute on Drug Abuse. NicVAX consists of the hapten 3'-aminomethylnicotine which has been conjugated (attached) to Pseudomonas aeruginosa exotoxin A.

<span class="mw-page-title-main">Benzodiazepine withdrawal syndrome</span> Signs and symptoms due to benzodiazepines discontinuation in physically dependent persons

Benzodiazepine withdrawal syndrome, often abbreviated to benzo withdrawal or BZD withdrawal, is the cluster of signs and symptoms that may emerge when a person who has been taking benzodiazepines as prescribed develops a physical dependence on them and then reduces the dose or stops taking them without a safe taper schedule.

Cocaine dependence is a neurological disorder that is characterized by withdrawal symptoms upon cessation from cocaine use. It also often coincides with cocaine addiction which is a biopsychosocial disorder characterized by persistent use of cocaine and/or crack despite substantial harm and adverse consequences. The Diagnostic and Statistical Manual of Mental Disorders, classifies problematic cocaine use as a "Stimulant use disorder". The International Classification of Diseases, includes "Cocaine dependence" as a classification (diagnosis) under "Disorders due to use of cocaine".

Post-acute withdrawal syndrome (PAWS) is a hypothesized set of persistent impairments that occur after withdrawal from alcohol, opiates, benzodiazepines, antidepressants, and other substances. Infants born to mothers who used substances of dependence during pregnancy may also experience a post-acute withdrawal syndrome. While post-acute withdrawal syndrome has been reported by those in the recovery community, there have been few scientific studies supporting its existence outside of protracted benzodiazepine withdrawal. Because of this, the disorder is not recognized by the Diagnostic and Statistical Manual of Mental Disorders or major medical associations.

Drug detoxification is variously the intervention in a case of physical dependence to a drug; the process and experience of a withdrawal syndrome; and any of various treatments for acute drug overdose.

<span class="mw-page-title-main">Alcohol withdrawal syndrome</span> Symptoms that can occur following a reduction in alcohol use after a period of excessive use

Alcohol withdrawal syndrome (AWS) is a set of symptoms that can occur following a reduction in alcohol use after a period of excessive use. Symptoms typically include anxiety, shakiness, sweating, vomiting, fast heart rate, and a mild fever. More severe symptoms may include seizures, and delirium tremens (DTs) which can be fatal in untreated patients. Symptoms typically begin around six hours following the last drink, are worst at 24 to 72 hours, and improve by seven days.

<span class="mw-page-title-main">Polysubstance dependence</span> Medical condition

Polysubstance dependence refers to a type of substance use disorder in which an individual uses at least three different classes of substances indiscriminately and does not have a favorite substance that qualifies for dependence on its own. Although any combination of three substances can be used, studies have shown that alcohol is commonly used with another substance. This is supported by one study on polysubstance use that separated participants who used multiple substances into groups based on their preferred substance. The results of a longitudinal study on substance use led the researchers to observe that excessively using or relying on one substance increased the probability of excessively using or relying on another substance.

Olivier Ameisen was a French-American cardiologist who wrote a best-selling book about curing alcoholism using the drug baclofen.

<span class="mw-page-title-main">Benzodiazepine dependence</span> Medical condition

Benzodiazepine dependence defines a situation in which one has developed one or more of either tolerance, withdrawal symptoms, drug seeking behaviors, such as continued use despite harmful effects, and maladaptive pattern of substance use, according to the DSM-IV. In the case of benzodiazepine dependence, however, the continued use seems to be associated with the avoidance of unpleasant withdrawal reaction rather than from the pleasurable effects of the drug. Benzodiazepine dependence develops with long-term use, even at low therapeutic doses, without the described dependence behavior.

<span class="mw-page-title-main">Amphetamine dependence</span> Medical condition

Amphetamine dependence refers to a state of psychological dependence on a drug in the amphetamine class. Stimulants such as amphetamines and cocaine do not cause physical dependence.

<span class="mw-page-title-main">Cannabis use disorder</span> Continued use of cannabis despite clinically significant impairment

Cannabis use disorder (CUD), also known as cannabis addiction or marijuana addiction, is defined in the fifth revision of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and ICD-10 as the continued use of cannabis despite clinically significant impairment.

<span class="mw-page-title-main">Psychoactive drug</span> Chemical substance that alters nervous system function

A psychoactive drug, psychopharmaceutical, psychoactive agent or psychotropic drug is a chemical substance that changes functions of the nervous system, and results in alterations in perception, mood, consciousness, cognition, or behavior.

<span class="mw-page-title-main">Charles P. O'Brien</span> American research scientist, medical educator (born 1939)

Charles P. O'Brien is a research scientist, medical educator and a leading expert in the science and treatment of addiction. He is board certified in neurology, psychiatry and addiction psychiatry. He is currently the Kenneth E. Appel Professor of Psychiatry, and vice chair of psychiatry, in the Perelman School of Medicine at the University of Pennsylvania.

Terren Scott Peizer is an American businessperson. He was the CEO and chairman of Ontrak Inc., a publicly traded healthcare company, but resigned in March 2023 after US authorities charged him with insider trading and securities fraud. He formerly worked as a junk bond salesman at Drexel Burnham Lambert, and ultimately testified against his former boss Mike Milken in Milken's securities fraud prosecution, in exchange for immunity from both criminal prosecution and SEC sanctions. He also held executive positions in small-cap technology, debt collection, bicycle tire, shoe importing, and biotech companies.

References

  1. 1 2 3 4 "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. 1 2 "UNITED STATES V. TERREN S. PEIZER". www.justice.gov. March 1, 2023.
  4. ↑ Prescription For Addiction, 60 Minutes' Scott Pelley Reports On A New Addiction Treatment, Dec. 7, 2007, http://www.cbsnews.com/news/prescription-for-addiction/
  5. ↑ "Prometa under fire in Washington drug court program". Alcoholism & Drug Abuse Weekly. 20 (3). January 21, 2008. doi:10.1002/adaw.20121.
  6. ↑ 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.
  7. ↑ 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 (2): 361–369. doi:10.1111/j.1360-0443.2011.03619.x. PMC   4122522 . PMID   22082089.
  8. ↑ "Hythiam EVP Lamacchia in long string of company layoffs". Treatment Magazine. November 21, 2019.
  9. 1 2 3 Alpert, Bill (November 7, 2005). "Curb Your Cravings For This Stock". The Wall Street Journal.
  10. ↑ Bartholomew, Dana (7 December 2018). "Catasys Thrives on Data Dives". Los Angeles Business Journal. Retrieved 12 August 2020.
  11. ↑ Alpert, Bill. "Curb Your Cravings For This Stock". Barrons. Retrieved 2020-11-26.
  12. 1 2 "Prescription For Addiction". CBS News. December 7, 2007.
  13. ↑ Polien Light, Nina (May 8, 2008). "An entrepreneur with heart". Cleveland Jewish News. Retrieved February 6, 2022.
  14. ↑ Kari Huus (February 5, 2007). "Unproven meth, cocaine 'remedy' hits market". NBC News.
  15. ↑ Humphreys, Keith (January 24, 2012). "The Rise and Fall of a "Miracle Cure" for Drug Addiction". Washington Monthly.
  16. 1 2 Ramshaw, Emily (January 20, 2008). "Texas' Prometa program for treating meth addicts draws skeptics". Dallas Morning News. Archived from the original on 2010-10-27.
  17. ↑ Adam Feuerstein (November 13, 2007). "Biotech Notebook: Hythiam, Shire, Genentech; Talk is proving cheap at Hythiam," TheStreet.
  18. 1 2 "Junk Bonds to Junk Science? Drug Treatment Program Questioned". Prison Legal News. June 15, 2008.
  19. ↑ "Hythiam stock price".
  20. 1 2 Urschel 3rd, Harold C; Hanselka, Larry L; Gromov, Irin; White, Lenae; Baron, Michael (2007). "Open-label study of a proprietary treatment program targeting type A gamma-aminobutyric acid receptor dysregulation in methamphetamine dependence". Mayo Clin. Proc. 82 (10): 1170–8. doi:10.4065/82.10.1170. PMID   17908523.
  21. ↑ 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 (2): 254–62. doi:10.1177/0269881109349837. PMID   19939864. S2CID   34039260.
  22. ↑ 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 (4): 334–42. doi:10.1097/JCP.0b013e3181aba6a4. PMID   19593171. S2CID   27738868.
  23. ↑ "PROMETA Protocol Adopted by Gary, Indiana". businesswire.com.
  24. 1 2 3 "Effectiveness of Prometa Treatment Protocol in Pierce County Drug Courts". Pierce County Performance Audit Committee.
  25. ↑ "Hythiam, Inc. Appoints Past Indiana State Attorney General and Former Head of National Drug Court Institute to Board of Directors". biospace.com.
  26. 1 2 Robinson, Sean (December 23, 2007). "Data show mixed value of Prometa". The News Tribune.
  27. ↑ Clarridge, Christine (July 9, 2006). "Pilot program helps ease drug addictions". Seattle Times. Retrieved 2008-08-25.
  28. ↑ Otto, M. Alexander (October 24, 2007). "Local officials owned stock in company". The News Tribune. p. 106.
  29. ↑ Robinson, Sean (November 11, 2007). "Success or failure? Probing Prometa" (PDF). The News Tribune.
  30. ↑ Otto, M. Alexander (October 24, 2007). "Council cuts off drug program" (PDF). The News Tribune.
  31. ↑ Wickert, David (November 21, 2007). "Council rejects Prometa funding request". The News Tribune.
  32. ↑ Wickert, David (November 6, 2007). "Politicians revise stock disclosures". The News Tribune.
  33. ↑ Maynard, Steve (November 22, 2007). "In Federal Way, Prometa gets council support". The News Tribune.
  34. ↑ "Junk Bonds to Junk Science? Drug Treatment Program Questioned". prisonlegalnews.org.
  35. ↑ "The Worst Judge in Dallas County". dmagazine.com.
  36. ↑ "Actor who died of overdose stars in addiction treatment ads". adage.com.
  37. ↑ "A warning sign on Sunset". Los Angeles Times.
  38. ↑ "Addiction treatment's effectiveness argued". The Seattle Times.
  39. ↑ "Billboard in Los Angeles". jugularnyc.com.
  40. ↑ "Chris Farley Lives on Billboard". eonline.com.
  41. ↑ "Lindsay's Shocking Drug Therapy". Star Magazine. October 24, 2007. Retrieved 2008-08-22.
  42. ↑ "I'm Going to Rehab" (video). True Life. MTV. December 6, 2007. Retrieved 2007-12-10.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.