Editor?s Note: The post originally appeared on The Fix, a Pacific Standard partner site.
In a better world, alcoholics and addicts could control their addictions medically via a one-a-day pill or, better yet, a monthly shot. With no side effects, this magic bullet would remove the craving and compulsion to get high. Of course, the need to escape??self-medicate??the pain of living in your own skin would remain, but antidepressants, 12-step, and other groups and therapy, if not sobriety itself, could go a long way to controlling that, too.
This hypothetical, er, cocktail of interventions?known as a ?functional cure??would make the disease of addiction manageable. The rate of recovery would jump from 20 percent, at best, to 90 percent.
It turns out that a pale version of this sci-fi medicine does exist. Called Vivitrol and made by Boston-based biotech Alkermes, it has been on the market for alcoholism since 2006 and for opiate addiction since 2010. It is not, however, a new drug. It is a new injectable formulation of an old drug called naltrexone, a once-a-day pill prescribed since the mid-?90s for addiction. The newsiest thing about Vivitrol may be its price tag. While naltrexone, a generic, has an insurance copay averaging $11 a month, Vivitrol costs?deep breath!?about $1,100 a month. A growing number of health insurers are covering all or part of the bill. But still?.
Vivitrol is no magic bullet. But like other drugs for alcoholism or heroin?starting with antabuse in the ?50s and methadone in the ?70s?the medical community has welcomed it as an additional tool in a skimpy arsenal. It is widely viewed as a significant advance over naltrexone because it appears to solve that one-a-day pill?s glaring drawback: the problem of compliance. Addicts had difficulty staying on it. Surrounded by environmental cues and hindered by bad habits, many people ?forgot? to pop it. By contrast, Vivitrol, a monthly injectable (the needle is stuck in a shoulder muscle), requires only a monthly doctor visit.
Some people in recovery swear by it. Wanda, a former opiate addict in her 40s, has been taking Vivitrol for 23 months. ?My life is all for the better,? she says. ?It?s expensive, but if you can find the money for the drugs, why can?t you find the money for the shot??
Others, not so much. William, a former alcoholic in his 50s, took naltrexone on and off over a period of years on his journey to sobriety. ?It was hard to tell if naltrexone helped with cravings,? he says. ?But any benefit was nowhere near big enough to be worth the price of Vivitrol.?
Neither Vivitrol nor naltrexone is a household word for addicts. Many doctors, when faced with a patient with a drinking problem, don?t think to offer it as a treatment option. Likewise, this addiction medication often gets short shrift in rehabs and 12-step programs. But being a patient means advocating for yourself, so if you want to, you may have to demand to give this shot a shot.
The question is, weighing the costs and benefits, should you? Is it really effective? And if so, will it work for you?
The FDA does not always get it right. In addition, the agency is often inclined to lower the bar for drug approvals when it comes to addiction, a serious disease with few treatments.
Like all brain diseases, addiction is maddeningly complex and remains a black box for neuroscience. But Vivitrol/naltrexone works in a straightforward way: It blocks the brain?s opiate receptors, stopping opiate triggers like alcohol, heroin, and painkillers such as Oxycontin. ?Vivitrol curbs your enthusiasm for the drugs,? says Timothy Fong, MD, director of the UCLA Addiction Clinic. ?It diminishes your urges and cravings.? It also blunts the pleasurable effects of intoxication.
Targeting opiate receptors is a daunting task, though, against substances as potent as alcohol and heroin, which set in motion a cascade of chemical reactions in the brain. There is evidence that Vivitrol works better against opiates than alcohol, however. The part of the opiate receptor targeted by Vivitrol is the same one that opiates attach to, allowing for a fairly complete blocking effect; against alcohol, which targets both that part and an additional one, Vivitrol is less powerful. ?Alcohol is a promiscuous substance,? says Erin Zerbo, MD, associate program director of the Addiction Psychiatry Fellowship at the NYU School of Medicine. ?It affects many receptors in the brain.?
The FDA looked favorably, if a bit peculiarly, on Vivitrol. Seven years ago, monthly Vivitrol injection won approval for alcohol dependence based in part on a six-month clinical trial: The 401 people on Vivitrol who completed the trial showed a 17 percent to 25 percent greater decrease in drinking days (no booze at all) and heavy drinking days (less booze) than those on placebo. But only 38 were abstinent. The rest decreased their alcohol consumption.
If fewer than 10 percent of those who got benefit from Vivitrol achieved abstinence, but 90 percent were able to moderate their drinking, the drug would appear to be most successful at?and best prescribed for?promoting controlled drinking, not abstinence. Yet the FDA slapped a label on Vivitrol saying that it is intended for patients who ?are able to abstain from alcohol in an outpatient setting.?
?How did the FDA come to that conclusion?? Helen Pettinati, MD, a researcher in addiction at the University of Pennsylvania?one of the trial?s principal investigators?said to Boston Magazine. ?Everybody thought they would be labeling around this ? major reduction in heavy drinking. People were surprised.?
In its analysis, the agency also concluded that Vivitrol works in one in five people.
The FDA was even more enthusiastic about Vivitrol for opioid dependence, generally viewed as a more intractable disease than alcoholism. In a clinical trial of 250 Russian addicts (most also had hepatitis C, some had HIV, and all were in desperate need of treatment), 90 percent of those on Vivitrol were abstinent for 19 weeks, compared to 36 percent of those on placebo. In addition to improving compliance, the drug had not only an anti-craving effect but what the FDA called an anti-relapse effect: People who ?slipped? were better able to climb back on the wagon before falling into a bona-fide relapse.
The agency took note that Vivitrol has few downsides: There?s no risk of abuse, addiction, or overdose, meaning it has no street value. It does, however, have a few potential albeit rare side effects. Especially flagged is its liver toxicity?no surprise, since that organ is often compromised in opiate addicts with hepatitis C. (However, after getting reports of 51 deaths associated with Vivitrol between 2006 and 2010?an estimated 45,000 patients had by then received the drug?the FDA added black-box warnings to the label.)
The FDA also noted its unsuitability ?for people who are philosophically opposed to agonist therapy (methadone or Suboxone) or patients whose employment prohibits agonist treatment, such as health care professionals, transportation workers, public safety officials, and military personnel.?
Nora Volkow, MD, director of the National Institute on Drug Abuse (NIDA), lauded the approval: ?Vivitrol obviates the daily need for patients to motivate themselves to stick to a treatment regimen?a formidable task, especially in the face of multiple triggers of craving and relapse?. NIDA is continuing to support research on Vivitrol?s effectiveness.?
But the FDA does not always get it right. In addition, the agency is often inclined to lower the bar for drug approvals when it comes to addiction, a serious disease with few treatments.
Oral naltrexone, having been around much longer than Vivitrol, has a track record that may raise some doubts. In 2010, the Cochrane Collaboration, the gold standard in independent reviews of drug studies, scrutinized all 50 available studies of naltrexone for alcoholism. Its conclusion? The drug did indeed help more patients reduce the amount and frequency of drinking than those who were on a placebo?at least for three months, which was the length of most of the studies. But Cochrane calculated that only one in nine people got these benefits.
Naltrexone?s effectiveness against opiates is another matter. In Cochrane?s 2011 review of all 13 available studies, naltrexone was no better than placebo. It did not help more patients stop or reduce their drug use; it did not keep more people in the trial and taking the pill. Nor was it superior to either Suboxone or the benzodiazepines (like Klonopin). The sole success naltrexone chalked up was in reducing by half the number of opiate users who got busted and locked up.
As for Vivitrol, Cochrane noted that there are not enough studies to do a fair review, but that ?the available studies indicate [it] might have comparable effects ? to those of oral naltrexone.?
Study results, whether positive or negative, strive for objectivity. But they cannot tell you how a drug works in the real world. The real world, however, tends to offer subjective anecdotes that often come down to ?she said, he said.? Consider these:
Wanda was addicted to pain pills, and in and out of rehabs, starting at age 12. Now in her 40s, she has been taking Vivitrol for two years and vouches for its dramatic effects. ?This is the first time in my life that I?ve been clean for this long,? she says. ?The Vivitrol shot is way better than naltrexone. I used to hide the pill in my gum, and then go use.? She used to be on methadone, but kept using because the cravings remained. Vivitrol has cut the cravings. Wanda admits that the shot is pricey but considers it money well spent?an investment in her health.
The prevailing treatment philosophy is that no single approach is best for everyone. Tailoring the treatment to the individual is the standard of care, even if doing so can involve trial and error.
The shot that is awesome for Wanda was merely ?meh? for William, a former alcoholic in his 50s. ?My problem was binge drinking on the weekends,? he says. ?Naltrexone blunted the pleasure I got from booze, but I just kept downing one beer after another anyway.? He took naltrexone on and off for a number of years in his journey to sobriety. His drinking did not get worse on naltrexone, and he had no side effects, so he kept giving it another try. As for Vivitrol, it was unaffordable. ?My doctor said there was no reason for anyone to jump to Vivitrol unless the problem was compliance,? he says. ?They are the same drug. If naltrexone doesn?t work, why try Vivitrol??
Some addiction specialists are gung-ho about Vivitrol and see a higher success rate than one in nine. ?Only about 40 percent of people respond to Vivitrol,? says UCLA?s Timothy Fong, ?but rates can be as high as 80 percent and as low as 20 percent.?
Robert Woolhandler, MD, an addiction physician in Pittsburgh, is fervent about Vivitrol?s compliance advantage. Over his career, he estimates that he has given some 3,000 Vivitrol shots. ?There is a big difference between Vivitrol and naltrexone?people just don?t take the pills every day,? he says. ?With the shot, it?s a different game.?
His one caveat is that the medication may work too well. Because Vivitrol eliminates cravings, patients can be lulled into the belief that their sobriety is more solid than it really is. They may not follow through with the rest of their recovery program, which should include psychosocial supports, such as the 12 Steps or counseling.
No drug works for everyone, and a 50 percent efficacy rate is about average for psychiatric medications. The trick is identifying who will benefit, and why.
?We?ve known for some time that naltrexone affects different people in different ways,? says James Garbutt, MD, medical director of the Alcohol & Substance Abuse Program at UNC-Chapel Hill. ?And we?re still trying to figure that out.?
Given the high cost of Vivitrol, a diagnostic test for sensitivity to, or likely success of, naltrexone would be immensely cost-effective. But given the immense complexity of addiction, such a test is only a remote possibility.
The limited research confirms what is already known about recovery odds. More severe forms of the disease, dual diagnoses with mental illness, and other psychosocial or health problems all decrease recovery rates. Predictably, high motivation and effective adjunctive therapy boost your chances.
But in the 2006 COMBINE study, which looked at 1,383 abstinent people from 2001 to 2004, only those people who combine naltrexone with medical management (basic alcoholism education) did better than those on placebo; naltrexone-takers who were also in alcoholic counseling (12 Steps and/or cognitive-behavioral therapy) did worst of all. Go figure.
Other clues are suggestive but scattered.
For certain addicts, opiate receptor blockers like Vivitrol are a problem, not a solution, says NYU?s Erin Zerbo. These people have an ?endogenous opioid deficiency??their brains don?t produce the normal supply of natural opiates. Only methadone or Suboxone may correct this chemical deficit by substituting a slow but steady opiate release.
Genetic testing of individuals in the COMBINE study showed that those who have a particular variant on the gene that regulates opiate receptors have a high success rate with naltrexone. But they are a minority of the population. Those who lack that variant did no better on naltrexone than on placebo. In any case, gene testing is too expensive to serve as a diagnostic tool.
So, to Vivitrol or not to Vivitrol? The best and maybe the only answer is a tautology: Take it if it will work for you.
The prevailing treatment philosophy is that no single approach is best for everyone. Tailoring the treatment to the individual is the standard of care, even if doing so can involve trial and error. ?I like to have a lot of treatment options,? says UCLA?s Timothy Fong. ?I don?t have just one philosophy.?
That may also be the optimal approach for anyone who is serious about getting and staying sober. Under certain conditions, Vivitrol may well be worth a shot: If you can afford it (check your health insurance formulary); if you have severe cravings and frequent slips (check your track record); if you have problems with compliance (check out generic naltrexone otherwise); and if you can make it to monthly injection appointments (check your fear of needles).
Addiction treatment is a long way from a ?functional cure? that would control the disease for the vast majority of people over a long period of time. A more realistic goal is for researchers to better identify the processes of addiction in the brain and, by using them as targets, develop more and better drugs.
?What we hope to do is to actually have a menu of treatments that clinicians could choose from,? Raye Litten, associate director of the National Institute on Alcohol Abuse and Alcoholism, told The New York Times last year. ?If one drug doesn?t work, patients try another one and so forth, and hopefully they?ll find one that is effective.?
Vivitrol and naltrexone are two of the the best choices on that very short list right now. But it pays to be mindful that no drug will work unless you also work, every day, at your recovery.
In part two of this investigation, The Fix examines the medical, moral, and monetary decisions made by the pharma company Alkermes in order to bring Vivitrol to market.
Raphael Rosen did much of the research, reporting, and fact checking for this investigation. Rosen is a Brooklyn-based science communications professional, social media strategist, and independent museum consultant. He has written for the Wall Street Journal, The Fix, the World Science Festival, Discover magazine, and others.
Source: http://www.psmag.com/health/vivitrol-help-control-addictions-57261/
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With India’s annual GDP growth of about 5 to 6 percent per year, a new wave of affluent consumers is coming. While there have been e-commerce successes like Flipkart, a handful of local startups are targeting the upper-end of the market. Squarekey is a startup that brings high-end fashion brands to India for the same prices as ones that a consumer would pay in the West. “Retail is stagnating the Western world,” said founder Avantika Daing. “The growth story is now in markets in India. We’re really addressing a big unmet consumer need. Our core base will include about 300 million users by 2015. Those are the potential users — the aspirational class that spans from the middle class to the upper-middle class.” The site offers clothes from about 65 brands including Nanette Lepore, Nicole Miller, BCBG Max Azria and Ben Sherman. While the site only opened last fall and Daing declined to share volume numbers, she did say that sales were growing by 30 percent month-over-month. Their average price point is around $175. India has strict regulations about allowing in “multi-brand” stores, or ones that offer multiple clothing brands. At the same time, individual clothing brands may not be at the point where they’re willing take the financial risk of entering the Indian market. “A Bloomingdale’s or a Barney’s cannot enter india with the current regulatory environment,” she said. “Single brands are permitted in India. There are some foreign direct investment nuances around minority and majority shareholders, but you do need a local partner.” She said brands give Squarekey access to their current season inventory, and they take care of everything from fulfillment to the last-mile delivery. They can drop ship to the first-tier cities in India within a few days for most of their goods, but other pieces that are flown in from the U.S. may take 10 business days. Over the last few years, a slightly older generation of e=commerce companies has figured out the logistical hurdles of delivering goods to consumers in the major cities. Plus, credit card penetration is improving. “Things like credit card usage are issues of yesterday,” Daing said. “The marketplace has evolved and an ecosystem of small and large e-commerce players have helped make barriers disappear.” She adds that Squarekey doesn’t take on inventory risk by buying merchandise upfront. “For the first six months, we did take inventory risk just to prove
Viewers will get a sneak peek into the daily operations of Betsy?s clothing line and meet some of the people that support and encourage her career. The ever-energetic Betsey took a minute to reveal some things that you and I may not know about her.
