Sunday, Dec. 9, 2007 | 2:22 a.m.
A Las Vegas drug court is considering a prescription drug-based treatment for methamphetamine addiction that drug counselors and addicts say works, even though it is backed by little science and has been tried and abandoned elsewhere.
The treatment, marketed by Hythiam Inc. under the name Prometa, is touted as a breakthrough in quickly reducing or even eliminating the disorientation and cravings addicts suffer. At its core is a regimen of prescription drugs not approved by the Food and Drug Administration for addiction treatment. Such "off-label" use is legal, although it is not legal to market it. Hythiam said it is not marketing the drugs themselves, only the way they are administered as part of a larger treatment.
Off-label use is sometimes followed by official recognition, the most famous example being the use of aspirin to reduce the risk of heart attacks and strokes.
Prometa uses three drugs approved for a range of conditions unrelated to addiction, including motion sickness and seizures. Studies to date suggest the drugs can also do for methamphetamine addicts what Hythiam claims they do - but those studies were paid for by Hythiam and tracked small numbers of addicts over short periods.
Addiction researchers, among them UCLA drug abuse expert Richard Rawson, say Prometa is blending science and marketing, with marketing coming out on top.
"It's not how the health care industry has traditionally developed treatments," Rawson said. "This one has been, 'Put it out to the public, and then we'll do some tests.' "
Addiction treatment medications in general have a history of looking promising in early trials. But so far few have withstood larger , independent and more rigorous studies, said Valerie Gruber, director of the Stimulant Treatment Outpatient Program at San Francisco General Hospital and a professor at University of California, San Francisco.
Early reports on addiction drugs often feature stories about addicts instantly cured and able to lead normal lives, she said, only for later and larger studies to show that the medication has no effect. With Prometa, it's too early to get patients' hopes up, Gruber said.
"Why can't (Hythiam) wait a couple of years until these trials are done?" she asked.
The Las Vegas Municipal Court, headed by Judge Cedric Kerns, is conducting a free 20-patient trial of Prometa. The court, responsible for treating drug addicts to keep them out of jail, will evaluate the results in February and then decide whether to pay for future patients.
"We're just giving it a shot and seeing if it works," Kerns said. "If we don't want it, we just tell them no thanks."
Before Kerns and the court decided to try out Prometa, they traveled to Pierce County, Wash., in late September to look at the Prometa program there, affiliated with a drug court and administered through a nonprofit clinic.
The Prometa program in Pierce County, however, has since collapsed in scandal. County auditors released a report last month that found the nonprofit clinic was skewing its results in a way that made Prometa appear wildly effective, often by not counting the people who dropped out of the program or were sent to prison.
Auditors also concluded that when the numbers were corrected, Prometa appeared only slightly more effective than traditional treatments, such as counseling.
The county council quickly cut off money for the program. Not long after, the Tacoma News Tribune reported that several public officials and the head of the clinic owned stock in Hythiam. Las Vegas' Judge Kerns told the Sun that he does not own stock in Hythiam and would consider it a conflict of interest to do so.
Kerns also said he was aware that Pierce County had canceled its program, but added that Las Vegas intended to continue with its trial.
One recent study of the treatment was conducted by Dr. Harold Urschel III of Dallas and funded by Hythiam. Urschel sells the Prometa treatment at his clinic.
In an interview with the Sun, Urschel said he is not affiliated with Hythiam because that could appear to be a conflict of interest. When asked later why his name appeared on a list of Prometa franchisees, Urschel said he sold Prometa before the study and he sells it now that the study has been completed. But he said he did not sell it while he was conducting the study.
Urschel's study was in some ways more stringent than previous evaluations. It included, as no previous study had, a control group of patients who received a placebo as well as an experimental group that received the drug . Like most of the earlier studies, it ran for only 30 days and with a limited number of patients.
According to Hythiam and Urschel, of the 134 patients who started the 30-day study, 88 completed it - 44 in each group. Compared with the placebo group, the Prometa group reported a statistically significant reduction in their cravings. There was also a reduction in self-reported methamphetamine use, but it was not statistically significant. The 46 addicts who dropped out of treatment were not included when the statistics were calculated.
What troubles critics is that these results were not announced at a scientific conference or in a medical journal, but on Nov. 1, just ahead of Hythiam's quarterly earnings report. (During a Hythiam conference call, Urschel said some patients were so happy with the treatment they wanted to buy stock in the company.)
"Again, publicity before results, this time before the peer review process," Gruber wrote in an e-mail to the Sun.
Hythiam officials, however, questioned why they should wait for studies to be completed when the drugs involved are individually safe for human use and are administered by doctors who seem to like Prometa's results.
"If the criticism is that we're making this available before all the double-blind placebo-controlled studies are done, then the flip side to that is that doctors who are using it believe that it's helping their patients," said Richard Anderson, Hythiam's senior executive vice president. "Is the flip side to that to say to us, 'Well, gee, you shouldn't let anyone use it; you should hold it to yourself and withhold it from people until that's done'?"
An independent double-blind study of Prometa, conducted by Dr. Walter Ling of UCLA, is under way. The results may be ready in early 2008. Rawson said the study would be the first serious scientific review of Prometa.
If it does work, "the question becomes: Is it worth $15,000?" Rawson said.
Private citizens typically pay clinics that provide Prometa $ 12,000 to $15,000 per month. Las Vegas expects to pay $5,000 if it contracts for further treatment. That is more than the cost of one 30-day outpatient program at the Betty Ford Center, and enough to pay for inpatient and outpatient treatment over a longer term in less upscale rehab clinics. (For comparison, a 30-day jail stay - which provides no counseling or medical care but does keep an addict away from methamphetamine for a month - costs taxpayers roughly $3,000.)
The Prometa regimen includes counseling and nutritional advice similar to conventional therapies. Hythiam didn't develop the treatment but purchased the rights to it from a clinic in Spain and is patenting it.
The drugs used in the treatment are flumazenil, approved as an aid in regaining consciousness after anesthesia; hydroxyzine, an antihistamine to control itching, motion sickness, anxiety and the symptoms of alcohol withdrawal; and gabapentin, prescribed to control seizures.
All three are available under low-cost generic labels and, in the dosages used in Prometa, cost about $150 combined for a month's treatment, based on the 2007 prescription budget for the clinic in Pierce County, Wash.
Hythiam said because the drugs are individually safe, the company needn't prove they are safe in combination. UCLA's Rawson said drugs that are safe individually can interact with one another dangerously, and they need to be evaluated together. "In the standard protocol, you can't just say it's safe and start marketing it," he said. "You have to prove it."
Moreover, Rawson said, Hythiam's proposed explanation for why the combination works - that the drugs repair a neuroreceptor damaged by methamphetamine, cocaine and alcohol - is all the more reason for caution. If it is true that Prometa is altering brain chemistry, it needs to be studied carefully, he said.
"It's a pretty big bit of tinkering to do without knowing it's safe," Rawson said.
The pitch for Prometa comes as many doctors and researchers are trying to change public perception of drug addiction from that of moral weakness to that of physical affliction. As that view shifts, the idea of a pharmacological magic bullet for addiction becomes increasingly attractive.
Unfortunately, few bullets have hit their mark. "Our culture is so oriented to medications that there's a lot of hope when there are these claims," Gruber said. "That can be exploitive when it costs 15 grand."
Hythiam attracted a great deal of attention last year with a billboard ad campaign in Los Angeles. The billboards featured a picture of comedian Chris Farley, who died of a drug overdose, and the phrases "It wasn't all his fault" and "Addiction is physical. The treatment is medical."
The billboards and other ads Hythiam has run across the country are meant to start discussions about addiction and not to overtly promote Prometa, said Sanjay Sabnani, Hythiam's executive vice president for strategic development.
"I think the rumors of us spending money on marketing have been greatly exaggerated," Sabnani said.
The Farley billboards also featured the word "Prometa" and a Web address, overcomeaddiction.com, a site that links to addiction resources. And all but one of the sites linked to are about Prometa, produced by Hythiam or offer contact information for Prometa franchisees.
Prometa's Web site is another target of critics. The site features images of lab-coated figures, which Rawson said is borrowing the trappings of science without undergoing its rigors. And only a small block of light blue text at the bottom of the site reveals that the treatment isn't FDA-approved.
"If you're not reading carefully you could get the impression that this is the latest thing that science has brought to the treatment of addiction," Rawson said. "And that's unfortunate because it's not true."
Hythiam has been selling Prometa to people undergoing court-monitored rehab and marketing the treatment to courts.
Kerns said he and other members of the Las Vegas HOPE court (the acronym stands for Habitual Offender Prevention and Education), which includes police officers and drug counselors, decided to give Prometa a shot after Hythiam offered the free 20-patient trial.
Kerns said if the court concludes that the program is a success (15 of the patients seem to be doing well), the company and the court will discuss fees. Kerns said Hythiam has mentioned the $5,000-per-patient fee.
Currently, the court has 48 defendants with varying addictions, which means the total cost could be "some serious money," Kerns said. But it would be cheaper than a 300-day stint in jail.
Kerns said Prometa would not be the only treatment offered by the court. "My program is not a 30-day program," Kerns said. "My program is a two-year program.
"It's a hard battle to fight, this meth problem, and any tool we can use, we'll use," Kerns said.
He said he is aware that people working with addicts sometimes think the addicts are recovering more than they are because they want to see them get better. He hopes that doesn't happen with Prometa.
"It could basically have the same placebo effect on us because we hope it works," Kerns said. "But I'm getting results from them that I haven't gotten before."
Skeptics such as Valerie Gruber caution, though, that hope is a dangerous substitute for evidence.
"If something seems too good to be true, it might just be so."
archive
