The US opioid epidemic seems to many to have come out of nowhere, and there’s been much finger-pointing in recent years about how this state of affairs came to be. Some have argued that inadequate mental healthcare is to blame. Others have postulated that doctors were naively over prescribing them as a way to quickly treat pain and please their patients. But, according to a recently published draft report, at least some of the blame should be attributed to the way pharmaceutical companies have manipulated patent extensions over the past decade.
In the 1970s and 80s, doctors were looking for better ways to control pain, and many believed opioids a good, non-addictive option. In the 1990s, drug manufacturers began aggressively marketing the painkillers to doctors and patients. Soon, patients (or their loved ones who stole their pills) were developing tolerances for low doses, and graduated to abusing the drugs by crushing them and either snorting or liquefying and injecting the powders, or turning to heroin, often fatally. By the time the science caught up in the early 2000s, it was too late: Thousands of people were addicted to opioids. Opioids have killed over 560,000 people in the US since 2000. Last month, president Donald Trump declared the crisis a public health emergency.
Pharmaceutical companies profited from this demand, and the exclusive rights they had to make these compounds. This allowed them to pump even more money into marketing, which inevitably led to doctors prescribing more of them.
From the moment a drug company patents a compound, it has 20 years of exclusive manufacturing and selling rights on it. In theory, a company’s monopoly on a drug dissolves after its patents expire and generics flood the market. But drug companies usually file for patents in the discovery stages as a way of staking their territory in the field. The approval process for drugs from the US Food and Drug Administration involves lengthy clinical trials, which usually take around 12 years—meaning that manufacturers typically only get to actually sell their drugs exclusively for about eight years before generics come onto the market. So they often seek ways to extend this exclusive period.
Perhaps the most common way is to change a drug ever so slightly. For example, a company can file a new patent if it makes a version of a drug with a slightly different dosage, or with a different way it’s released in the body over time.
“Our patent system doesn’t require something to be better, just different,” says Robin Feldman, the director of the Institute for Innovation Law at the University of California Hastings College of Law. “Rather than creating new medicines, pharmaceutical companies are largely recycling and repurposing [drugs].” The manufacturer can then hold off generic competition for a few more years. Competitors (or anyone else) could theoretically make the case in court that these compounds aren’t actually different, but the legal battle would likely be too costly and time consuming to be worth it.
Feldman, together with Connie Wang, a law student at Stanford University, meticulously went through a decade’s worth of versions of the US Food and Drug Administration’s “Orange Book” and US Patent and Trademark Office website listings to investigate the relationship between patent filings, exclusivity extensions, and drug approvals. They found that of the 100 best-selling drugs from 2005 to 2015, about 80% (paywall) had a patent extension filed on them at least once. About 50% of these drugs had multiple extensions.
That, Feldman argues, can create a dangerous cycle. “The immense monopoly profits allow drug companies like Purdue to aggressively market their drugs to doctors,” explains Feldman. “Physicians preferentially prescribe these particular drugs. Where drugs are addictive and problematic, that’s dangerous.”
Purdue Pharma is the company behind one of the most popular prescription opioids. OxyContin first came on the market in 1996 and has since brought in billions of dollars of revenue. Purdue’s patent for OxyContin was originally supposed to expire in 2013. But by making minor tweaks to the drug’s chemical structure to create a slow-release pill the company markets as “abuse-proof,” Purdue has been able to file new patents for OxyContin 13 times with the US Patent and Trademark Office over the past decade, thereby extending its exclusive selling rights on the drug through 2030.
Purdue did not respond directly to Feldman’s analysis when forwarded a copy by Quartz, instead providing a statement noting, “One potentially important step towards the goal of creating safer opioid analgesics has been the development of opioids that are formulated to deter abuse. FDA considers the development of these products a high public health priority. Purdue reformulated OxyContin with abuse-deterrent properties recognized by FDA, and the Patent and Trademark Office granted Purdue patents for inventions that went into the development of those properties.”
The most prominent example is a patent Purdue filed in 2003 for “abuse-proof” OxyContin. It was made of materials that are harder to crush, and forms a gel that is more viscous and harder to inject. In theory, it would make for a safer alternative to regular OxyContin. However, the same patent claims that “intravenous administration of such a gel would most probably result in obstruction of blood vessels, associated with serious embolism or even death of the abuser.” In all likelihood, people crushing these pills to get high would still seriously harm, if not kill, themselves.
Technically, the abuse-proof pills worked: When researchers from Washington University in St. Louis informally surveyed more than 2,500 people taking opioids to see if this pill really was more abuse-proof than before, they found that the number of people who admitted to using it to get high dropped from about 35% to about 13% two years later. However, two thirds of respondents said they had switched to other opioids instead—often heroin, which is less expensive and easy to use.
It’s not Purdue’s fault doctors kept prescribing (and overprescribing) these pills in an attempt to alleviate pain, nor that the loved ones of patients often took instead to get high. It’s also not the company’s fault there weren’t better resources for those who found themselves addicted—drugs like buprenorphine, methadone and naltrexone can help ease addiction, but as recently as 2016, they still weren’t being given to patients in two-thirds of US addiction clinics.
That said, Purdue spent many years and huge sums of money convincing doctors that OxyContin was non addictive. In fact, the company has paid over $600 million (paywall) in fines to federal and state agencies, as well as individual patients, to settle claims that it falsely marketed OxyContin as safe from abuse. Three of the company’s executives pled guilty to “misbranding,” which is a criminal violation.
The company is still profiting off “abuse-deterrent” OxyContin. Though there are currently “authorized generics” of OxyContin available, these are made by manufacturers with licenses to use Purdue’s formula. In other words, Purdue makes money off them. And there are currently no approved abuse-deterrent generics in the US. In September of this year, FDA commissioner Scott Gottlieb said that soon the agency plans to issue guidelines to assist companies who are trying to file applications for these types of generics. No word on when that document will be published, however.