The new FDA chief's plan to stop the drug overdose epidemic has a huge flaw
REUTERS/Gary CameronFood and Drug Administration Commissioner nominee Doctor Robert Califf (C) arrives to testify during his nomination hearing before the Senate Health, Education, Labor and Pensions Committee on Capitol Hill in Washington, November 17, 2015.The new commissioner of the Food and Drug Administration, Dr. Robert Califf, told a panel of FDA advisers last week that he will do "everything possible under our authority" to help the federal government curb an epidemic of drug overdoses.
A January CDC report revealed the number of drug overdose deaths reached a new high in 2014, totaling 47,055 people. Opioids, a type of powerful painkiller that requires a prescription, were involved in 60% of those deaths.
In his address, Califf cited a number of strategies to reduce overdoses, including stronger warning labels, safer disposal to reduce diversion of drugs, and encouraging the development of opioids specifically designed to discourage abuse, such as pills that can't be crushed and snorted.
These drugs, often called "abuse-deterrents" are not new: The FDA has approved five of them since 2010; another 30 are currently in development, according to the Associated Press.
Abuse-deterrent formulations aim to prevent users from manipulating pills and abusing them. Abusers often crush them up for snorting or dissolve them so they can be injected. To prevent this, some drugmakers are experimenting with special coatings or polymers that prevent them from being crushed, or combining chemicals that attempt to cancel or reduce the effect of the drug if it were used improperly. Others have also tried adding what are called prodrugs to some formulas, which prevent the drug's activation until it enters the stomach.
But there's one big problem with this strategy, which also happened to be the main focus of Califf's address: The evidence is anything but conclusive that abuse-deterrent drugs actually deter abuse.
One study from researchers at Washington University in St. Louis surveyed people at 150 drug treatment facilities in 48 states on the primary drug they abused in the past month. The study found that the introduction in 2010 of an abuse-deterrent version of the powerful prescription painkiller Oxycontin initially correlated with a steep decline in its abuse. However, this effect leveled off in the following years. At the end of the study, more than 25% of those surveyed reported using Oxycontin in the past month, leading the researchers to conclude that abuse-deterrent formulations have "clear limits" to their effectiveness.
AP Photo/Toby Talbot, FileThis file photo, shows OxyContin pills arranged for a photo at a pharmacy in Montpelier, Vt.
While these studies reveal a murky picture of abuse-deterrents at best, there is one thing that's clear from talking to pain specialists: Many abusers have no trouble getting past the roadblocks put up by abuse-deterrent formulations.
As Dr. Houman Danesh, the director of Integrative Pain Management at Mount Sinai Hospital, put it, "Where there's a will, there's a way."
"Pharmaceutical companies keep coming out with new formulations that they say are deterrents, but overall everything that has been tried has been somehow abused," Danesh told Business Insider.
Any cursory search on Google, web forums, and Reddit will reveal methods to break abuse-deterrent formulations.
The larger problem is that abuse-deterrent formulations aren't addressing the biggest part of prescription opioid abuse.
Dr. Ted Cicero, a professor of psychiatry and the leader of the Washington University study, puts it this way:
"Overall if a person is intent on using [opioids] intranasally or injecting, they will figure out a way to do it. … [O]n the other hand, the way that most people abuse these drugs is by swallowing them. We are not touching that part of the problem. Most people don't inject opiates. They take them orally … There really is no way at the current time to develop a formulation that wouldn't be abusable by the oral route."
Dr. Neel Mehta, the medical director of pain management at Weill Cornell Medical College, likened abuse deterrent formulations to a "burglar alarm."
"If you have it, it's unlikely someone is going to try to get into your home, but if they really want to, they will."
Not everyone agrees, however.
David Haddox, Vice President of Health Policy at Purdue Pharma, acknowledged that Purdue's current abuse-deterrent drugs, which include Oxycontin, Targiniq, and Hysingla, could be abused with enough effort, but said that the evidence doesn't show that such drugs are actually being abused in large numbers. The real issue, according to Haddox, is that only around 2% of opioids currently prescribed are classified as abuse-deterrent, meaning it is still far too easy for addicts and abusers to switch to another, often cheaper drug.
"If you like snorting oxycodone, it's a lot easier to use something like a generic oxycodone tablet rather than spending the time and the effort to work around a product designed to deter snorting," Haddox told Business Insider.
2012 National Survey on Drug Use And HealthStill, there are reasons to be skeptical of abuse-deterrent formulations, and the problem doesn't appear to be just that people are using cheaper drugs like heroin instead of prescription painkillers like Oxycontin. Between 40% and 70% of people who abuse prescription pain relievers get them from friends or family members with legitimate prescriptions.
"I am not convinced that we can engineer our way out of this epidemic, and I would caution against over-relying on abuse-deterrent formulations to do so," said Dr. Caleb Alexander of Johns Hopkins University, according to the Associated Press.
The FDA has acknowledged the limitations of abuse-deterrent formulations in the past. In October, Dr. Janet Woodcock, the agency's director of the Center for Drug Evaluation and Research, testified that it's impossible to make "an impregnable fortress" out of pain pills.
One of the biggest problems is that it's hard to define when an abuse-deterrent pill is effective. The FDA only laid out final guidelines on abuse-deterrent drugs last April. Studies on the effect of abuse-deterrent drugs other than Oxycontin have yet to be released.
In 2012, Endo, a pharmaceutical company specializing in pain medications, reformulated its prescription pain pill Opana to have abuse-deterrent properties. The new formulation turned the pill into a gel that supposedly made it hard to snort or inject when crushed. In 2013, the FDA found Opana was still easy to inject or snort despite the new formulation.
The FDA was right. The abuse-deterrent formulation of the drug was likely tied to an HIV outbreak in Indiana last June that resulted in 165 cases of the disease. The CDC interviewed 112 of the people who contracted HIV, finding 96% of them had injected Opana using shared needles.
The abuse-deterrent capabilities of other pain pills approved by the FDA have been similarly panned, as with Purdue Pharma's Targiniq drug.
Haddox, the Purdue Vice President, said that, though Purdue's abuse-deterrent formulations do not mitigate abuse from ingestion, it is meaningful to try to deter abuse by snorting and injection, which he called the more dangerous methods of abuse.
"The technology is like a seatbelt right now. We're at the combined lap belt and shoulder belt stage," said Haddox. "When I was a kid we had no seat belts. Then we got lap belts. Then we got shoulder belts. Now, we have anti-lock brakes and reinforced cabins. Technology gets better and better."
According to Haddox, the "holy grail" for the pharmaceutical industry is an opioid that delivers relief for patients while preventing abuse by ingestion. Another concept is a pain reliever that doesn't activate the "reward circuits" in the brain (i.e. what gives opioids their "high"). As of right now, those concepts are still fantasy. However, Haddox cautioned against writing off abuse-deterrent drugs just as they are taking off.
"[Abuse deterrent drugs are] a whole new area of pharmaceutical science and development and research. I think it is safe to say that we are much better off having this technology than not," Haddox said.
Part of the problem, however, is a widespread misunderstanding of where the technology is at right now. Though the FDA admits that abuse-deterrent drugs should "meaningfully deter abuse" even if they can't "fully prevent" it, the distinction is getting lost on many doctors.
A national survey of doctors in 2014 by Johns Hopkins University found a third of doctors think prescription drug abuse occurs by means other than swallowing pills. Almost half of those surveyed thought abuse-deterrent pills were inherently less addictive. Both of those assertions are completely false.
Given all that, it becomes easy to understand how dangerous it is when the FDA touts pharmaceutical companies' new abuse-deterrent formulations as the main solution to the opioid abuse crisis. Though these drugs ostensibly make it harder to inject or snort, they are still abusable.