Rising addiction rates are adding to already huge unmet needs in treating drug dependence, but big pharmaceutical companies show little interest in developing medications for common dependencies such as cannabis and methamphetamine. This volatile environment begs for trailblazers who can fill the void, but inconsistent patient behavior, lack of clear regulatory pathways, and other factors present recurring obstacles.
Meanwhile, addictions for which there are approved treatments take an ever-larger societal toll, with heroin overdose deaths soaring and alcoholism causing 88,000 deaths a year. These are some of the factors that are shaping addiction treatment and drug development today.
The opiate epidemic
It’s hard to overstate the toll opiate abuse is taking on our society. From 2002 to 2013, heroin overdose deaths in the U.S. increased by 286 percent, and the trend is only now starting to abate as the FDA and DEA push for greater public awareness. Many of the new users are people who got hooked on opiate painkillers that became much more available in the 2000s but lately have become difficult and expensive to obtain. A large new population of users turned to heroin, a more available, much cheaper — and highly addictive substitute. How much so? I’ve never known of an oxycodone addict trying heroin even once and then going back to oxycodone.
For societal impact, no mood-altering drug compares with alcohol. Twenty-nine percent of Americans suffer from some degree of alcohol use disorder. The impact on health care expenditures is staggering, and so are the social consequences: Today, one child in 10 lives with an alcoholic parent.
But where are these treatments?
Efficacy notwithstanding, there are a few medications to treat alcohol and opioid dependence but none yet that have risen to the top as the gold standard. And there are no approved drugs for addiction to stimulants such as cocaine and methamphetamine, cannabis, sedatives, and hallucinogens. With use growing fast, especially in states that have approved recreational consumption, marijuana could be America’s next big epidemic. Of special concern is the fact children recently questioned on the subject rated cannabis as a low-risk drug.
Another unaddressed need is dual diagnosis, the combination of mental illness and substance addiction. A patient diagnosed with, for example, schizophrenia and alcohol dependence is likely to be treated for schizophrenia alone. Just a relative handful of studies have attempted to really address both sides of dual diagnoses.
Many obstacles at work
So why are big pharma companies not developing drugs to beat these addictions? For one thing, often there is no clear regulatory pathway. Consider cocaine, which has defeated every attempt at finding an effective therapy. Regulators have yet to even establish an accepted treatment endpoint for cocaine dependence disorder.
Operational challenges are many, too. Patients must fully detoxify before a trial begins, a standard that can be hard to meet. Patient compliance is another issue: After all, a drug can’t be evaluated effectively if patients don’t take it as directed. There’s a very high rate of relapse among members of control groups, with one recent study experiencing four mortalities among its control population.
Patients face their own array of challenges. There’s the social stigma imposed by a society that, in large part, doesn’t understand the science of drug dependence. Asking an addict, “Why can’t you just stop using?” isn’t especially helpful. Abusers often don’t have social support structures — they have a habit of burning bridges — and can have trouble getting to medical appointments.
Another obstacle for pharma companies is concern about abuse liability. You need to understand and carefully follow the FDA guidance on the new drug’s abuse potential before starting any trial.
Yes, these are serious obstacles — but the problems we’re struggling to overcome are enormous. The industry needs trailblazers to take on development of new treatments. We understand the physiology of addictions and recognize, through too many life-shattering examples, the consequences of ineffective or nonexistent treatment. We must turn greater attention to combating this scourge.