Texas' Prometa program for treating meth addicts draws skeptics

Yes! More Prometa coverage on LifeLube, this post via the Jan 20 Dallas Morning News.

Our favorite quotes from the story -

"I don't think anybody should be spending any amount of money on something that hasn't been clinically researched to be safe and effective," said Dallas Criminal District Judge John Creuzot, who was approached about the pilot program but refused to participate. He said the company marketing the treatment is "in the business of making money, and they did a great sales job on some well-intended legislators in Texas."

And we like this section too...

Kathryn Cunningham, director of the University of Texas Medical Branch's Center for Addiction Research, said it's true that some medical treatments can alter brain chemistry to curb drug cravings. The problem, she said, is that there's little proof Prometa is one of them.

"There's been a lot of marketing hype before the evidence exists. This is not something I'd personally want to spend my taxpayer money on," said Dr. Cunningham.

"I know a lot of scientists in this area, and we're all singing the same tune," she said. "This is misguided."

Read the full story here.

Read more LifeLube postings on Prometa here.

Snake Oil for Meth Addiction - Only $15,000

LifeLube's Jim Pickett was invited back to Bilerico (after his Future of Anal Sex post was something of a hit) to do a guest post on the controversial drug treatment protocol called Prometa.

Prometa is a controversial and unproven treatment protocol for alcohol, cocaine and methamphetamine addiction that is being heavily marketed by the Hythiam company. Since gay men are disproportionately dealing with crystal meth problems, we are in Hythiam’s unscrupulous sites.

So what’s the skinny on Prometa?

Basically this drug protocol uses three already FDA approved drugs for an off-label use. Off-label use is the practice of prescribing drugs for a purpose outside the scope of the drug's approved label. The drugs used in Prometa have yet to be proven safe and effective for treatment of crystal meth addiction. That’s a big deal. It means that data from randomized, double-blind, placebo-controlled studies have yet to be published. A trial is currently underway at UCLA and we might see some results in the next quarter.

Read the rest.

Setbacks plague (supposed) drug addiction remedy

[LifeLube continues to bring you the latest skinny on the controversial and unproven drug treatment called Prometa. As Prometa supposedly cures crystal meth addiction, we all need to be informed, and wary, of ANY treatment that sounds too good to be true.]


Prometa pilot program loses funding
amid questions over effectiveness

By Kari Huus Reporter
MSNBC
updated 4:49 a.m. CT, Fri., Jan. 11, 2008

A trial of a controversial drug cocktail designed to treat meth and cocaine addiction has been halted after an audit found that the treatment’s success rate had been “greatly exaggerated.”

The action was a major blow to Hythiam Inc., which licenses the “Prometa protocol” to private doctors and stands to benefit financially if it can gain access to public funding of drug treatment across the country. Coupled with subsequent media reports that public officials who championed the pilot program owned stock in Hythiam, the news sent the company’s shares plummeting from more than $8 a share in October to about $2.75 this week.

Read the rest.

Read more LifeLube blog coverage of the controversial and unproven Prometa protocol here.

For even more background on Prometa, check out the info page on Crystal Breaks here.

Be a smart consumer of substance abuse treatment!

And learn more about the controversial Prometa drug treatment protocol.

Click here for these great resources.

Bottom line - don't be a sucker!

Data show mixed value of Prometa

[Read more LifeLube posts on Prometa.]

SEAN ROBINSON; The News Tribune (Tacoma)

Published: December 23rd, 2007 01:00 AM

The record of success is uneven. The stock price is sinking in a morass of government scrutiny and media skepticism. The hype machine is running on fumes.

It's been a rocky two months for Prometa, the anti- addiction treatment regimen hailed by some as a life-changer, scoffed at by others who doubt its reputed virtues.

The slide started Oct. 24, when Pierce County auditors released a report debunking Prometa's claimed effectiveness in the local drug court.

Members of the Pierce County Council later voted to cut county funding for the program, though it's still backed by state funding.

In the aftermath, Hythiam Inc., Prometa's parent company in Santa Monica, Calif., endured tough local and national media coverage, capped by a Dec. 7 report on the "60 Minutes" television news program.

Hythiam stock is sucking air in the fallout. It's lost almost two-thirds of its value in eight weeks. On Oct. 23, it was trading for $8.56 a share. Friday, it struggled to stay above $3.

For Terren Peizer, Hythiam's chairman and CEO (right), who owns about 13.7 million shares of company stock, that represents a loss of more than $75 million.

NO COMMENT FROM HYTHIAM

The first quarter of 2008 could be Prometa's make-or-break moment.
Results from several studies of the treatment are due to arrive, including a preliminary evaluation by the University of Washington, which is studying Pierce County's Prometa program.

The News Tribune took a closer look at Prometa's performance in drug courts around the country, seeking records of results and assessments from court leaders. Hythiam officials were also consulted, but they declined to answer questions.

"I don't think we are going to be able to comment at this time,"
spokeswoman Rachel Carr said in an e-mail Tuesday.

Read the rest of this story.

Read more LifeLube posts on Prometa.


BONUS - Check out LifeLuber Jim Pickett spouting off about Prometa on The Morning Show with Mike and Juliet here, and afterwards in the Green Room here.

Marketing hype or a miracle cure?

[note to LifeLube readers... as you know, we have been sharing coverage of the controversial, expensive, and evidence-free Prometa treatment protocol for crystal methamphetamine addiction because the company has been targetting gay men in its aggressive marketing. the Chicago Tribune story below is the first of its kind from a major news outlet, and we couldn't be more delighted. Tonight, 60 Minutes is also doing a story on Prometa - we will be on our couch ready to go for that one and expect a nice, critical piece. see previous post for more on that... we want more effective treatments for meth addiction as much as anyone - but ones that are PROVEN, thank you very much, before we plunk down 15 grand.]

Costly treatment for drug addiction
spurs heated debate

By Deborah L. Shelton
Tribune staff reporter
December 9, 2007

A costly drug cocktail touted as the first pharmacological treatment for cocaine and methamphetamine addiction is at the center of a raging national debate.

The treatment, called Prometa, is not approved by the Food and Drug Administration as an addiction therapy, nor has it undergone extensive scientific testing. But officials at Los Angeles-based Hythiam Inc., the company that sells the treatment protocol, say it can work miracles for people struggling to break their addiction.

David Smart turned to Prometa when he hit rock bottom eight months ago. Smart had lost everything -- his wife, his family, his job and his home. By his own estimate, he had failed at least two dozen times to overcome his meth addiction.

"I had tried everything and nothing worked for me," said Smart, 41, of suburban Tacoma, Wash. "But Prometa has."

Mario Acosta Jr. also tried Prometa but relapsed within days of completing treatment.

"They told me it would work for everything," said Acosta, 44, a longshoreman in San Pedro, Calif., who was battling alcoholism and heroin addiction.

He took out a $5,000 loan to help pay for it. "What a waste of money that was," he said.

As many as 3,000 people have tried Prometa, up from about 1,000 a year ago, a Hythiam spokesman said. Prometa was first offered in 2003 as the HANDS Protocols.

More than 70 physicians nationwide have been licensed by the company to treat patients. Hythiam promotes Prometa as a 30-day outpatient treatment for addiction to alcohol, cocaine, heroin and meth, also known as crystal meth.

Doctor: 'Marketing scheme'

But some treatment professionals say the company rushed to treat patients with Prometa before it had undergone greater scrutiny.

"I don't think Prometa is a drug treatment for addiction; I think it's a marketing scheme," said Dr. Alex Stalcup, a California-based expert on methamphetamine addiction.

Some addiction experts said the treatment is reminiscent of controversial methods promoted in the past.

"There is an attempt to create hype before there is actual evidence, make a buck and move on," said Chicago addiction specialist Dr. David Ostrow, who attended a meeting here organized by Hythiam last month. "These kinds of treatments have come and gone like garden weeds in the field of addiction."

Hythiam officials said the company's attention-grabbing marketing shouldn't be confused with its treatment."People are dying [from drug abuse], and this [treatment] seems to be making a dramatic difference," said Dr. Matthew Torrington, medical director of the Prometa Center in Santa Monica, Calif., one of four such treatment centers.

Jim Pickett, chairman of the Chicago Crystal Meth Task Force, says Hythiam is pushing an untested treatment on people when they are at their lowest point. His outrage grew after he saw a full-page ad for Prometa in Gay Chicago Magazine.

"They are preying on vulnerable people," Pickett said. "People in the throes of crystal meth addiction -- and their families -- are extremely vulnerable, and they are taking advantage of it."

Natalie Bauer, a spokeswoman for Illinois Atty. Gen. Lisa Madigan, said the office has seen a rising number of questionable claims of successful treatments for meth addiction.

"Atty. Gen. Madigan shares the concern expressed by treatment professionals and Chicago Crystal Meth Task Force members that Hythiam has undertaken an aggressive marketing campaign on behalf of Prometa without first showing that Prometa is an effective treatment for addiction to methamphetamine or other substances," Bauer said.

Read the rest here.

Read more LifeLube posts on Prometa here.

"Prescription For Addiction" on 60 minutes this Sunday

[not to miss!]

(CBS) An increasingly popular drug protocol that addicts and some doctors say has been effective in curbing drug and alcohol cravings is an unverified treatment that a former junk bond salesman is marketing through a loophole in federal drug regulations, several prominent addiction doctors say.

One of them, Dr. John Mendelson, who specializes in addiction medication, tells 60 Minutes correspondent Scott Pelley that the treatment, called Prometa, has little science to back its claims in a report to be broadcast this Sunday, Dec. 9, at 7 p.m. ET/PT.

Prometa is touted as new treatment for methamphetamine, cocaine and alcohol addiction. It is a combination of three drugs already approved by the FDA. Mendelson says none has been proven effective individually against addiction. Could there be something special about taking them in combination? "So far, the evidence would suggest no," says Mendelson, who tests addiction treatments for the National Institute on Drug Abuse.

Read the rest.

More on Prometa from Washington State

LifeLube has been following the Prometa saga from Pierce County, WA and admittedly dropped the ball on this story due to running off to Buenos Aires. Below is the latest news on the matter from the end of November - and news we approve, btw - on what happened with Pierce County's funding for the controversial, unproven and VERY EXPENSIVE drug treatment for crystal meth and alcohol addiction called Prometa. We have been following Prometa as the parent company - Hythiam - has been targetting the gay community with marketing around this protocol. Buyer beware.

Drug project funds killed

Exec can’t get Prometa votes

DAVID WICKERT; The News Tribune

Published: November 22nd, 2007 01:00 AM

Pierce County Executive John Ladenburg’s last-ditch effort to save funding for the Prometa drug treatment program did not sway the County Council.

Instead of setting aside $400,000 for Prometa in the 2008 budget, the council designated the money for “decreasing the Pierce County jail population or evidence-based programs that are directed towards breaking the cycle of drug addiction.”

The council also set aside the $175,000 in unspent 2007 Prometa funding for the same purpose, bringing the total to $575,000.

The council took no action on Ladenburg’s proposal to spend the money on Prometa.

Council Chairman Terry Lee, R-Gig Harbor, said Prometa could qualify for the funds “if it becomes a program based on evidence-based results.”

Councilman Shawn Bunney, R-Lake Tapps, said the council will ask its Performance Audit Committee to devise performance measures that will be applied to programs such as Prometa, with the ultimate goal of reducing the jail population.

“We need to do a much better job of measuring and holding people accountable for outcomes,” Bunney said.

The council last month suspended 2007 funding for Prometa – used to treat addicts in county drug court – after a performance auditors’ report found little evidence that the program is effective.

On Tuesday, Ladenburg made a last effort to revive Prometa funding by offering budget language addressing several council concerns.

The executive’s plan would have prohibited managers and board members of the nonprofit Pierce County Alliance – which administers Prometa for the county – from owning stock in Hythiam Inc., the company that licenses the drug and counseling treatment. The plan also would have removed language from the alliance’s contract with Hythiam that required it to market Prometa.

Read more about Prometa on LifeLube.

More Prometa Drama from Tacoma

[If you have been paying attention and not just frequenting LifeLube for the darling boys we feature, you most certainly know we have spent a fare amount of time sharing media coverage from Washington state and Chciago on the controversial drug treatment protocol by the name of Prometa. The company that is marketing Hythiam, is actively targeting gay men who are addicted to crystal for this very expensive ($15g) and UNPROVEN scheme. We want to make sure that you - and other significants in your life - are informed consumers of drug treatment. If it sounds to good to be true, perhaps it is. At the end of this post there is a link to all of our other Prometa postings, fyi.]

Ladenburg OKs Prometa suspension

DAVID WICKERT; The News Tribune - Tacoma, Washington

Published: November 16th, 2007 01:00 AM

Pierce County Executive John Ladenburg approved a measure Thursday that suspends current funding for the controversial Prometa drug-treatment program.

But the executive still hopes to reach a compromise with the County Council that would salvage $400,000 in funding for Prometa in the county's 2008 budget.

Ladenburg is proposing a compromise that would address key council concerns, including stock ownership by people who oversee the treatment and additional evidence of its effectiveness.

"I am firmly committed to pursuing full funding for the program as contained in my 2008 proposed budget," Ladenburg wrote in a letter to council Chairman Terry Lee, R-Gig Harbor. "The issues which caused the council to freeze the funding for the remainder of 2007 are not insurmountable."

In April the council agreed to spend $400,000 to use Prometa in county drug court. The treatment program uses generic drugs and counseling to reduce cravings in addicts.

Supporters say Prometa has made a dramatic difference in the lives of addicts. But a county performance auditor's report last month suggested claims of Prometa's effectiveness had been exaggerated and found proof of its effectiveness is lacking.

Council members also became concerned when several Prometa supporters admitted they owned stock in Hythiam Inc., the company that licenses the treatment program.

Among those who bought stock were Ladenburg, state Rep. Dennis Flannigan, D-Tacoma, and employees of Pierce County Alliance, the nonprofit that administers Prometa for the county.

On Oct. 23 the council voted 4-3 to suspend 2007 funding for Prometa in light of questions about its effectiveness. Ladenburg threatened to veto that decision.

Instead, on Thursday he signed the measure, which included supplemental funding for other county programs.

"I didn't want to jeopardize the funding for the other parts of this budget ordinance," Ladenburg said in an interview.

And as the council hurries to finish the 2008 budget, Ladenburg said he didn't see the point in taking up the council's time with a vote on whether to override his veto.

"Obviously they have concerns," Ladenburg said. He said he hopes to address those concerns by proposing a compromise that would persuade some council members to change their minds about 2008 Prometa funding.

The council will finalize a budget Tuesday, and Ladenburg said his staff will work this weekend on a Prometa funding measure he hopes can gain the approval of a council majority.

Among the issues the compromise would address:

* Hythiam stock ownership by employees of Pierce County Alliance.

* Language in the nonprofit's contract with Hythiam that requires the agency to market Prometa.

* Continuing demonstrations of Prometa's "superior effectiveness."

Ladenburg said he could provide no details. And he said there's no guarantee a compromise can be reached.

It will be difficult to convince some council members.

Councilman Shawn Bunney, R-Lake Tapps, said it makes more sense for the county to invest the $400,000 sought for Prometa in proven drug-treatment programs.

"We simply do not have the dollars to waste on something as unproven as (Prometa)," Bunney said.

Lee, the council chairman, may be the swing vote. He's supported Prometa funding in the past.

Lee said he's not opposed to providing funding for Prometa in 2008 if supporters can demonstrate that it's effective. But he needs more evidence.

Lee said the council might support more funding for drug programs generally - not Prometa specifically.

If Prometa supporters can prove its effectiveness, the treatment program could get funding, Lee said.

"I think that any appropriation for Prometa or any other drug program would be conditioned on evidence-based results," he said.

Read other LifeLube posts on Prometa here.

Pierce County Council unlikely to fund Prometa in 2008

County drug project dying

Pierce council unlikely to fund Prometa in 2008

DAVID WICKERT; The News Tribune (Tacoma, WA)

Published: November 15th, 2007 01:00 AM

The Pierce County Council seems poised to end all funding for the controversial Prometa drug-treatment program in the wake of a public hearing on the program Wednesday.

Two former Prometa supporters on the council – Council Chairman Terry Lee, R-Gig Harbor, and Councilman Roger Bush, R-Graham – said they heard nothing at the hearing to persuade them to restore 2007 funding for the program or to include additional funding in the county’s 2008 budget.

“I didn’t hear anything that was earth-shattering,” Lee said after the hearing.

County Executive John Ladenburg will announce today whether he’ll veto an Oct. 23 council decision to suspend 2007 funding for the program. But with 2008 funding now in doubt, a veto could be a short-lived victory for supporters who say Prometa has dramatically changed the lives of drug addicts.

Earlier this year the council voted 5-2 to spend $400,000 to use Prometa in county drug court. The program – administered by the nonprofit Pierce County Alliance – uses three generic drugs and counseling to reduce cravings in addicts.

Supporters say Prometa has been life-changing for many who have undergone the treatment.

“Prior to getting Prometa, I couldn’t speak complete sentences,” said Melony Wild of Tacoma. She told the council she’s been an addict for 23 years, but has been drug-free for four months because of Prometa.

“I know it’s a miracle,” Wild said.

David Smart of Federal Way told the council he tried various treatments before turning to Prometa. He said he’s been clean for seven months.

“I just know I’m not going to do dope again,” Smart said.

But such personal testimony was countered by a skeptical report from Matt Temmel, the county’s performance audit coordinator.

In a report issued last month, Temmel’s office found little evidence Prometa is effective. And an updated report released Wednesday raised additional questions about the claims of success that have been used to woo investors for Hythiam Inc., the California-based company that licenses the treatment program.

The revised report found 57 percent of people in a 2006 Pierce County Prometa study remained drug-free after 14 months. That’s far below the 86 percent success rate touted by Pierce County Alliance and Hythiam.

The report said supporters have made Prometa look more effective in part by excluding certain participants who were not successfully treated. It also questioned supporters’ definition of “drug free” and cited other problems with interpreting data.

The report concluded scientific proof of Prometa’s effectiveness is unlikely to be available soon.

Councilman Shawn Bunney, R-Lake Tapps, focused on marketing and financial ties between Hythiam and the Pierce County Alliance when questioning the nonprofit’s representatives.

Under Bunney’s questioning, the alliance’s chief financial officer, John Neiswender, acknowledged Hythiam had written two of the nonprofit’s news releases, though he said the nonprofit reviewed them.

And he admitted one news release’s claim that clients were drug-free for 14 months was misleading.

But Tom Leander, president of the nonprofit’s board, defended the Prometa treatment and maintained county auditors aren’t qualified to judge its effectiveness. He said he’s seen the impact of the treatment on clients and can’t wait for scientific proof.

“You don’t wait 10 years to save lives and treat people,” Leander said. “You take advantage when you have that advantage.”

A majority of council members appears unconvinced. Bunney and Councilman Dick Muri, R-Steilacoom, are longtime Prometa skeptics. Now some former supporters on the council have changed their minds.

“I never heard any rebuttal for the specific statements of the auditors,” Bush said after the hearing. “All we heard were general statements, ‘We don’t like (the report), We’re against it.’”

Councilwoman Barbara Gelman, D-Tacoma, who has supported funding for Prometa, now says she’s undecided.

“They haven’t made a real good case,” she said of the treatment’s supporters.

The nonprofit is still receiving county funds to administer Prometa while Ladenburg decides whether to veto the council’s suspension of 2007 funding. The county executive has requested an additional $400,000 for 2008.

Lee said the 2008 funding is in doubt. The council will finalize next year’s budget by Tuesday.

Read more LifeLube postings on Prometa here.

Lotta Hot Air from Hythiam on Prometa

Via The Street

Is there a CEO in health care who talks more but says less than Hythiam (HYTM - Cramer's Take - Stockpickr - Rating) head honcho Terren Peizer?

[Peizer is pictured above left ringing the NASDAQ bell last year]

I think not, especially after listening to two recent Hythiam conference calls -- one to discuss results from a clinical trial involving its controversial Prometa drug-treatment program, the other focused on third-quarter financial results.

Both calls were marathon affairs in which Peizer, if paid by the spoken word, would have earned himself a place on the Forbes 400 list. Sadly, most of what Peizer says is dubious-sounding hype, although happily, investors seem to see through it all. The result: Hythiam's stock price is in free fall.

Hythiam shares have dropped 50% to $3.65 since announcing "positive" results from the Prometa study on Nov. 1, followed by "record" third-quarter results one week later.

It didn't take much more than a cursory read of the press release announcing the trial results to see that Hythiam was playing a fast and loose with its analysis, counting only those patients who completed treatment, excluding those who dropped out.

Maybe Hythiam didn't think investors and analysts would notice this data fudge, but when they did, Peizer and his team became mighty defensive. The low point of the conference call came when the study's lead investigator -- someone who's supposed to be an independent and objective arbiter of Prometa -- began recounting personal stories of meth addicts in the trial buying Hythiam stock because they were convinced that the treatment had turned their lives around.

Read the rest.

Read more LifeLube posts on the Prometa controversy here.