The Milwaukee Post

OxyContin follows directly from that; it just shot up." Working to understate addictive properties By 2007, three of Purdue's exec- utives had pleaded guilty to mis- branding the drug by understating its addictive properties. They were convicted of criminal misde- meanors and paid a massive fine. But the drug remained on the mar- ket. Purdue is a family-owned Connecticut company, founded by psychiatrist brothers. Sent ques- tions, including one asking about addiction risk (studies are mixed, but many experts consider the drug highly addictive for some patients), the company responded in writing: "For more than a decade, Purdue has been working with pol- icymakers and health experts to address the risks associated with prescription opioids. We believe the pharmaceutical industry has the responsibility and unique abil- ity to help evolve the analgesic market, which is why we've taken a leadership role in developing opi- oids with abuse-deterrent proper- ties." People have used opium in a cruder sense throughout history; morphine, invented to help wound- ed soldiers, was named after Morpheus, Greek god of dreams, according to History Today. German scientists working for Bayer, known for aspirin, created heroin (the word "heroisch" means "heroic" in German) from morphine in 1874, trademarking and selling it as a cough suppres- sant, according to the White House Agency for National Drug Control Policy. Doctors worldwide soon prescribed heroin. According to History Today, heroin was Bayer's first "commer- cial medicine." By 1928, though, a regulatory era began as Congress banned heroin after murders in New York. Illegal heroin spiked during the Vietnam War, as anyone who has seen the movie "American Gangster" knows. Purdue's spokesman provided research showing OxyContin is just 2.7 percent of opioid pill pre- scriptions. But OxyContin's launch sent statistics soaring, coming on the heels of a decade- old national pain movement that slowly liberalized doctors' pre- scribing habits. Official agencies and groups now embraced the pain move- ment's concept of "balance." In 2001, the federal Drug Enforcement Administration and 21 other organizations issued an unprecedented statement urging "balance" in opioid regulation — finding a way to regulate abuse without stopping legitimate use for pain. Numerous states passed Intractable Pain Acts to shield doc- tors from punishment who used controlled substances to treat patients in pain. Professional soci- eties worked against what was called "opiophobia." Studies showed regulatory bodies used outdated terms and were too restrictive, and medical boards started rewriting policies. These actions gave Purdue's marketing the legitimacy it needed to many doctors (although some researchers and associations were taking drug company grants). Then, data started to come in, showing more abuse than expect- ed. Last year, the Centers for Disease Control and Prevention found that over 60 percent of drug overdose deaths now involve phar- maceutical drugs, mostly opioids. Heroin deaths doubled in nine years, according to the CDC. Local stats Medical examiner's statistics for the last 11 years of Waukesha County overdose deaths show most of the 385 who died had ingested opioid pills. According to the med- ical examiner: ■ Drug overdose deaths rose from 15 in 2003 to a high of 59 in 2012. Last year, there were 37. About 17 percent were suicides. Almost all of the rest were acci- dents, with a few undetermined. ■ In almost 80 percent of drug overdose deaths since 2003, people had opioids in their bodies (heroin or prescription pills), often in com- bination with other prescription drugs or alcohol. In 21 percent, oxycodone was the opioid found (that's the drug in OxyContin; however, Purdue Pharma points out that oxycodone, also developed by scientists long ago, is found in many prescription opioids). ■ Heroin was found in 55 cases; the peak year was 2012, with 20 deaths. Morphine was found in 74 more cases. Sometimes, because heroin metabolizes so fast, medical examiners only detect morphine. However, sometimes people die from taking morphine. People also died after ingesting opioids like methadone and fentanyl. ■ More victims were male. The average age was 37, dropping from a high of 51 in 2004. There's a reason those poppies put Dorothy to sleep as she headed to Oz. According to the CDC, over- doses occur because the drugs depress people's breathing. Purdue's marketing efforts were critical, says Dr. Michael Miller, who runs the addiction recovery center at Rogers Memorial Hospital in Oconomowoc; now opioids were prescribed to a general pain popu- lation, a huge market — some 76 million Americans. Previously, opioids were restricted to surgical use and terminal cancer patients. Opioids that aren't heroin still are not controversial for "end-of- life" patients. But Andrew Kolodny, a leading opioid addiction expert, says that wasn't a big enough market for a "blockbuster" drug — terminal patients won't be on the drug long. Backs, knees — now those were fair game too. However, some doctors say the term "non-chronic cancer pain" is not easily defined; as anyone whose loved one has suffered from pain knows, it can be truly debili- tating; and some cancer patients are in remission and aren't "end- of-life" either. Seeking balance The question becomes where and how to find balance — how much risk can and should society tolerate to stop the pain of mil- lions? Should risk be stopped with regulation and limiting access, merely with education (put pills in a lockbox) or a mixture? The answer depends on which part of the elephant a person sees: If you're a grieving parent whose child used heroin, you might fall one way; if you're a doctor with suffering patients, another. Jackson is frustrated that years after convictions and with public health costs of OxyContin well known (including its heroin link), more hasn't changed (although in 2010, Purdue reconfigured the pills so they can't easily be crushed and snorted. The company also stopped selling a higher dosage). There is evidence the reformu- lation pushed some pill addicts to use heroin instead. James Bohn, who runs the local DEA office, says people also turned to other forms of oxycodone. "I was at their sentencing hear- ing in Virginia in 2007 and we thought, 'Oh here's a victory, final- ly, they're convicted.' We thought that would change things, but if you look at the statistics, their sales kept going up, they didn't take a setback at all," says Jackson. Many Americans want opioids for pain. Patients don't just want their pain controlled, doctors say; they want it eliminated. Their expectations have changed. "It's a great drug," insists UW- Madison pharmacology professor June Dahl of OxyContin. Dahl was one of a few researchers whose pain management advocacy helped relax doctors' attitudes toward pre- scribing opioids. "It's no different than morphine in any real sense," she says. David Cleary, who now runs the UW's Pain & Policy Group, which advocates international and national medical use of opioids for serious pain relief, provided a study showing only 3.6 percent of opioid users try heroin. However, research says 80 percent of heroin users start with opioids; Kolodny thinks there is an even bigger pre- scription pill crisis. "OxyContin is continually over- prescribed by doctors for people with many types of moderate pain who should never have been given this drug in the first place," says Jackson. "This widened use can be directly traced to the marketing campaign of Purdue Pharma." If Dahl could change one thing, it's "Purdue's marketing," she says. She was one of their speak- ers; respected researchers she knew were hired by Purdue and were "doing the asking." Now she feels "possibly used." Purdue had marketing down to a science. Drug companies identi- fied physicians with many chronic pain patients and gave a lucrative bonus system to OxyContin sales representatives who reached them, Van Zee wrote, training sales reps to say the addiction risk was 1 per- cent (Kolodny says it's about 25, but others say it ranges from below and above that and depends on the patient). Parent questions FDA Jackson believes enough atten- tion isn't given to the Food and Drug Administration, which had the power to stop the drug. The FDA's small staff size for oversee- ing promotional materials com- pounded things, said Van Zee. The FDA's response has been to weigh the risks and benefits. Last year, in response to a petition from Kolodny's group, the FDA ordered changes to extended-release pre- scription opioids' labeling to "more effectively communicate the serious risks of misuse, abuse, 6 • Milwaukee County Post • September 26, 2014 See HEROIN on Page 7 Heroin: Fishing hats and CDs: How Big Pharma marketed a new drug continued from Page 1 Submitted photos Recently seized heroin. It is often packaged in small amounts for easier distribution at cheap prices. People addicted to opi- oid painkillers frequently turn to heroin because the drugs are chemically similar.

• Cover