Authors: John Temple
Cephalon promoted its berry-flavored narcotic lollipop Actiq for migraines, sickle-cell pain, and injuries, despite the fact that the FDA had approved its use only for cancer pain.
Janssen Pharmaceuticals, Inc. promoted the narcotic Ultracet for everyday chronic pain, distributing posters to doctor’s offices that showed people in active professions with the breezy tagline “Pain doesn’t fit into their schedules.”
Endo, maker of Opana, Percocet, and Percodan, distributed a patient education publication that said withdrawal symptoms and increased tolerance to narcotics are not the same as addiction. “Addicts take opioids for other reasons, such as unbearable emotional problems.”
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The overall impact of the lollipops and posters and authoritative assurances was to create the impression that prescription opioids were like any other class of drugs—a life-enhancer like the erectile dysfunction pills or acid reflux tablets advertised on TV.
The tactic of distinguishing between addiction and physical dependence was key to many of the feel-good campaigns. On their drug labels, the companies were required by the FDA to acknowledge that opioids are addictive narcotics that could kill. But the companies often left that information out of patient education materials. Brochures and websites often mentioned only the least scary side effects of the drugs, usually leading with constipation, which no doubt seemed a small price to pay for pain relief. The drug companies also highlighted drowsiness, confusion, nausea, and dizziness, among other mild complaints. And the side effects would probably go away in a couple of days, they assured.
Janssen sponsored a multimedia patient education campaign called “Let’s Talk Pain,” which warned that strict regulatory control had made doctors fearful to prescribe opioids, leaving patients to suffer in pain: “This prescribing environment is one of many barriers that may contribute to the under treatment of pain, a serious problem in the United States.”
Despite the competition, Purdue continued to be the face of the opioid gold rush because it had introduced the first blockbuster narcotic. In response to the bad press, Purdue eventually did make a number of concessions. The company put additional warnings about addiction in its information about OxyContin. It stopped making the much-sought-after 160-milligram mega-pill. It began reporting physicians it believed might be diverting drugs.
Hundreds of lawsuits were filed against Purdue, mostly personal-injury claims from small-town plaintiffs claiming they’d been hurt by the drug, and the drugmaker was committed to winning them all. No trials, few settlements. Purdue hired big-gun corporate defense law firms in Atlanta and New York and spent $3 million a month in legal bills. The company beat back almost every lawsuit, including a number of class-action cases.
When Purdue finally lost a big one in 2007, it was a criminal case, not civil. The charge was led by a US attorney named John Brownlee, whose district in Roanoke, Virginia, had been devastated by pharmaceutical painkillers. Brownlee had prosecuted street dealers and doctors and finally decided to investigate the top of the narcotics chain. The company pleaded guilty to federal criminal charges that it had lied about the drug’s risk of addiction. Three top executives paid $34.5 million in fines and the company paid $600 million, one of the largest such fines ever paid by a pharmaceutical company.
Golbom and a group of activists traveled to Virginia for the sentencing, and Golbom spoke at a rally outside the courthouse. Golbom let loose. A photographer snapped a picture of him mid-cry, his face contorted in anger, chopping a hand through the air. The anger was real, but his outbursts on the radio and at the rally were not quite genuine. His natural state was quieter, more analytical. But he was experimenting, willing to do anything to strike a chord.
Golbom didn’t want to do away with opioids. Morphine was a godsend for someone with pancreatic cancer, someone hospitalized for trauma. But over the long run, he increasingly believed, few people seemed to get better on the stuff. He didn’t even want new laws; he just wanted people to better understand what they were taking.
And to Golbom, the federal government’s approach to the opioid crisis was contradictory.
On one hand, there was plenty of concern and action. The feds had gone after Purdue, and the Centers for Disease Control and Prevention had published report after report on painkiller deaths. Lawmakers held hearings and railed about oxycodone crime and addiction in their districts. The DEA stepped up its investigations of doctors whose patients had died after receiving huge prescriptions.
On the other hand, the government was ultimately responsible for the flood of narcotics. The FDA signed off on one new opioid formulation after another—patches, lollipops, and pills, pills, pills. Many observers questioned why the FDA was so compliant with the pain industry. What escaped most people’s attention was that the pharmaceutical companies had an even more dependable ally in, ironically, the Drug Enforcement Administration.
One of the DEA’s most important and least recognized duties is to decide how much of each controlled substance can be manufactured. If the DEA decides that the amount of oxycodone being made exceeds the “medical, scientific, research, and industrial needs of the United States,” it can reduce the drug’s production, simply cut it down by denying pharmaceutical companies’ annual requests to manufacture more of the drugs.
Instead, year after year, the DEA had signed off on hikes in the manufacturing quotas of all popular prescription narcotics. Golbom dug up the numbers. And they were stunning.
In 1993, three years before OxyContin came out, the DEA allowed pharmaceutical companies to manufacture 3,520 kilograms of oxycodone.
In 2007, the DEA signed off on the production of seventy thousand kilograms of oxycodone.
Almost twenty times the amount manufactured just fourteen years earlier.
Twenty times.
Less than four tons compared to seventy-seven tons.
And it wasn’t just oxycodone. Between 1996 and 2007, the DEA had nearly quadrupled the production of hydrocodone, allowed manufacturers to produce almost ten times the amount of fentanyl, and hiked the quota of hydromorphone by four and a half times.
Despite its impact on public health, the quota-setting process was conducted in secret. Each pharmaceutical company applied to make a certain amount of a given controlled substance each year, but the DEA wouldn’t reveal how many pills each wanted to produce. That was considered to be a trade secret. Then, the companies and the DEA had negotiation meetings, the content of which was restricted from the public record. The DEA then set quotas based on “expected need.” Essentially, the only information the DEA revealed each year was the total amounts of each drug requested by the entire industry and the total amounts the DEA allowed them to produce. The DEA said it would be unfair to the pharmaceutical companies to reveal how many pills the individual companies wanted to manufacture.
Amid the uproar over painkillers and all the strategies invoked to curb abuse and overprescription, few officials or politicians seemed to consider simply reducing the supply. The idea had been brought up seriously only one time, in 2001, when the country was first becoming aware of Oxy-Contin abuse. The DEA had asked Purdue to restrict OxyContin prescribing to physicians trained in pain management, and Purdue balked. In response, during a congressional subcommittee hearing, DEA administrator Donnie R. Marshall said he was considering “rolling back those quotas to 1996 levels.” The pain industry said this would be a disaster, that prices would skyrocket and pain patients would suffer. Purdue didn’t budge, and the quota-cut idea vanished when new administrators came in.
Cutting back the quotas wasn’t a radical idea. In fact, the DEA had combated drug waves by reducing quotas before. In the 1970s, when speed pills were popular, the DEA cut the quota of amphetamines by 90 percent, and the illicit market dried up. A decade later, sedative-hypnotics like Quaa- ludes swept across the country, and the DEA cut the quota of the ingredient methaqualone by 74 percent, which effectively erased the problem.
Now, prescription narcotics were killing far more people than speed or sedatives, but the government was signing off on large increases in the supply each year. It baffled previous DEA administrators like Gene Haislip, former head of the DEA’s Office of Diversion Control. Haislip had been in charge during the methaqualone quota reduction. It hadn’t been easy to buck the pharmaceutical industry, but, as he told a reporter shortly before his death: “You’ve got to have some kind of principles.”
Golbom had come to the conclusion that a $7 billion industry had been built on marketing and bad science.
By 2008, the United States was awash in prescription narcotics, enough for every American adult to pop a 5-milligram Vicodin every four hours for nearly a month. According to the International Narcotics Control Board, the US had consumed 83 percent of the global supply of oxyco-done in 2007. And
99 percent
of the world’s hydrocodone. No one believed that the US was in that much more pain than the rest of the world.
Golbom could see how it had happened. It wasn’t the 1970s or the 1980s any more. Pharmaceuticals were the most profitable industry in the country, and the pharmaceutical lobby was by far the biggest in Washington.
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He’d never considered himself prone to conspiracy theories. But now he had his own pet belief that he couldn’t stop thinking about. He’d been an unwitting tool of the conspiracy for years, until it had infiltrated his home. When he came across an advertisement for radio time—“You, too, can be on the radio!”—he decided to take the leap. To Golbom, prescription narcotics seemed like a natural topic for a talk radio show. By now, just about everyone knew someone who had a problem with pain pills.
Golbom spent three weeks writing his first hour of radio. He wrote out every word of the early shows. His stomach churned every week when he walked into the station. To protect his job and his son, he called himself “Larry G” on air. And he never explained in any depth why he’d begun investigating controlled substances. His personal story didn’t matter. He also wouldn’t reveal his employer. He needed his pharmacy job.
Each week he interviewed different drug experts, legislators, recovering addicts. There were always fresh topics to discuss—a suspicious new pain clinic in town, a new narcotic coming out, new legislation. His network of listeners kept track of trends and reported back to him.
On the July 6, 2008, show, Golbom reported a strange new phenomenon. A pain clinic in Pinellas Park seemed to be serving customers primarily from out of state. Golbom told his listeners what his source had seen.
“One car had a Louisiana license plate. Another car had a New Jersey license plate. This individual saw cash going back and forth, and they saw the deal get done. And here’s what so frightening, folks: We are now becoming the suppliers for people around the country.”