FDA overlooked danger of painkillers

Now that the opioid crisis has reached epidemic-level proportions, many of us are asking who’s to blame. The list of answers is long: those who overprescribed, foreign importers of fentanyl and other deadly opioid additives, Mexican drug cartels, individual consumers, unscrupulous drug distributors, certain pharmaceutical companies, and on the list goes. Yet one actor has largely avoided public ire as opioid addiction blossomed into our generation’s most troubling public health emergency: the U.S. Food and Drug Administration.

First, a bit of background: Anyone who’s ever worked in the biotechnology or pharmaceutical industries understands the critical importance of the FDA. No matter how much brilliance and dedication goes into the development of a new therapy, no drugmaker can sell that therapy until the FDA confirms that the proposed therapy is both safe and effective. Typically, drugmakers demonstrate safety and efficacy during an expensive, three-phase clinical trial process that often lasts nearly a decade.

Partially because of the high costs of those clinical trials, and partially because of the larger dynamics of the American health-care market, the development costs of new pharmaceuticals are extremely high. By some estimates, the cost of developing a new drug reaches as high as $2 billion. Yet the benefits of owning a popular drug are astronomical: Last year, the highest-selling drug in the United States netted more than $10 billion in revenues. This creates a conundrum for drug developers: how to maximize blockbuster new therapies without paying the sky-high costs of drug development.

In practice, this has created a remarkable incentive for big drug companies to repackage already tested and marketed therapies. And there are a variety of strategies pharmaceutical companies employ: They can seek extended patent protection for their blockbuster drugs, apply old drugs to new disease indications, or develop new formulations or delivery mechanisms. This latter strategy led directly to the nation’s most famous prescription opioid: OxyContin.

OxyContin, or “Oxy” as it’s often known, was sold by Purdue Pharmaceutical and promised “smooth and sustained pain control all day and night.” Though Purdue had developed a technique to delay the full release of the drug’s payload, its claims about all-day relief were bogus — so bogus, in fact, that Purdue was fined about $600 million in 2006 and is now a defendant in lawsuits across the country. Indeed, Ohio Attorney General Mike DeWine recently initiated one such lawsuit against Purdue and other pharmaceutical companies. In the suit, DeWine correctly argues that drugmakers misled doctors and their patients about the potential for opioid abuse.

Purdue certainly acted unethically, and might have even acted illegally, but our legal system places one significant barrier between companies like Purdue and the American consumer: the FDA.

With Oxy, evidence of its potential problems arose almost immediately. A single dose, for instance, promised to relieve pain for 12 hours. But about half of the enrollees in OxyContin’s first clinical trial required additional medication before their 12 hours elapsed, according to one report. And despite the potential for addiction that any narcotic opioid possesses, Purdue never tested the drug as a six- or eight-hour pain reliever before selling it. The FDA never required that testing. OxyContin became one of the most successful pharmaceutical products in the country, other prescription opioids followed it onto the market, and America’s consumption of opioid pain medications skyrocketed.

OxyContin’s story is hardly unique. In 2006, the FDA approved Opana, one of the most heavily abused prescription opioids, despite the fact that Opana was very similar to a drug that had been removed from the market in 1979. The reason for its removal? That it led to addiction and abuse.

Sometimes, the FDA’s fundamental mistake appears to be its failure to treat addiction with the seriousness that it treats other potential health problems. Typically, drugmakers must show that their drugs won’t provoke the human immune system, won’t damage kidneys, livers, and other internal organs, and can be manufactured safely. Yet addiction doesn’t receive the scrutiny it deserves.

Thankfully, there are early signs that the FDA is finally looking at this issue seriously. The FDA’s new commissioner, Dr. Scott Gottlieb, has spoken at length about the addiction crisis, and just this year the agency announced that it was removing Opana from the market.

Many experts argue that the FDA needs significant reform, that in its caution it delays truly revolutionary therapies — like lifesaving cancer treatments and non-addictive pain drugs. These are important debates, but even in its current form the FDA could have prevented a lot of harm.

For better or worse, the FDA is the primary gatekeeper separating dangerous drugs from the American public. It feel asleep at the wheel, and states like Ohio are facing the consequences.