Who fueled opioid boom?


Written by Mark Curnutte | The Cincinnati Enquirer

Drug companies, medical groups might be responsible for dual health crisis

Thirty years ago, the use of opioids was so restricted that Dr. Rebecca Bechhold could not prescribe them to manage the pain of terminal cancer patients.

“It’s a godsend” for the terminally ill, said Bechhold, 25-year medical director at Hospice of Cincinnati, who first prescribed an opioid, MS Contin, in the late 1980s.

So how did the United States change in a generation from a society that sharply restricted the drugs to prescribing them routinely for everything from dental work and migraines to backaches and fibromyalgia?

Pharmaceutical companies linked to medical organizations that advocated better ways to treat pain worked hard — and spent heavily — to pave the way for prescription painkillers’ broader use, critics say.

Sales of prescription opioids increased 93 percent nationally from 2001 to 2012, up from $4.4 billion to $8.5 billion, according to IMS Health, a health care technology and information company. That fueled a dramatic spike in opioid overdose deaths — for example, a 483 percent increase in Ohio from 2000 through 2011, according to state records.

As problems emerged, documented by federal watchdogs as early as 2003, regulators reacted slowly, allowing opioid abuse to mushroom and build demand for heroin, which Mexican suppliers were bringing to the United States in record amounts.

U.S. Senate investigators are examining whether drugmakers and several organizations — including the nation’s largest health system accreditation group, the Joint Commission — colluded to downplay the addictive powers of prescription painkillers and exaggerate their benefits.

Late in October, the U.S. Food and Drug Administration recommended that hydrocodone, the most-prescribed opioid, be classified as a Schedule II controlled substance, making it harder to get legally.

Also in October, the Ohio Governor’s Cabinet Opiate Action Team released new guidelines for opioid prescribers. Though lacking the force of law, they call for lower dosages to be prescribed for shorter times with greater physician oversight.

“We need to retrain doctors — No. 1 — not to overuse opioids,” said Orman Hall, chairman of the panel.
Pill makers' ties to education pose risk

Rewind just 18 years. The release by Purdue Pharma in 1995 of OxyContin, a synthetic opioid designed to provide daylong pain relief through timed release of oxycodone, led opioids to explode into wider use as treatment for chronic pain.

Then in 2001, the Joint Commission — which accredits and certifies more than 20,000 health care organizations and programs nationally and has been criticized for its close ties to Purdue — issued guidelines calling for more aggressive measures to treat pain.

In 2003 — eight years after the release of OxyContin — a government report pointed to collusion involving Purdue and the Joint Commission that ultimately helped Purdue make OxyContin widely available through primary care physicians.

The Government Accountability Office, the investigative arm of Congress, reported that, in 2001 and 2002, Purdue paid for a series of programs across the country to instruct hospital doctors and staff how to comply with the Joint Commission’s 2001 pain guidelines.

Purdue, one of two drug companies to provide money to pay for the Joint Commission’s pain management education programs, was the only company allowed to distribute educational videos and a book about pain management, which were available to buy on the Joint Commission’s website.

From 1996 to 2002, Purdue paid for 20,000 pain-related education programs through which doctors earned required continuing education credits, according to the GAO.

OxyContin sales for privately held Purdue jumped from $44 million in 1996 to $1.54 billion in 2002.

The Joint Commission agreed to respond only in writing to Cincinnati Enquirer questions about its 2001 guidelines and its relationship with Purdue, which is one subject of a Senate Finance Committee probe.

It said that “the inadequate treatment of pain was recognized in the 1990s as a growing public health issue. The compelling science led the Joint Commission to rewrite its accreditation standards in 2001. It is important to note, the decision on treatment is left to the provider who is evaluating the patient.”

Regarding its relationship with Purdue, the commission wrote only this: “Corporate sponsorship policy in place at the time strictly prohibited the involvement of Purdue (or any funder) from serving on funded project committees, panels, work groups or from attending these meetings. Funders were also prohibited from involvement in the design, implementation and conduct of the research and standards development process.”

From 1998 through 2001, Purdue distributed coupons for free trials of OxyContin; 34,000 of the coupons were redeemed, according to the GAO. Those coupons were part of what the GAO described as Purdue’s “extensive campaign to market and promote OxyContin using an expanded sales force to encourage physicians, including primary care specialists, to prescribe OxyContin not only for cancer pain but also as an initial opioid treatment for moderate-to-severe non-cancer pain.”

Purdue said it acted responsibly when it learned of problems of OxyContin abuse.

“For our part, when Purdue became aware in 2000 that the abuse of our product was becoming a problem in some communities, we took a number of steps to help address the issue,” said James Heins, a company spokesman. “Additionally, we spent more than 10 years working to reformulate OxyContin to make it more difficult to manipulate for the purposes of misuse and abuse.”

But in 2007, Purdue pleaded guilty to a federal count of misbranding the drug and paid $600 million in fines and other penalties. Three Purdue executives, including its president and top lawyer, pleaded guilty as individuals and agreed to pay $34.5 million.

Purdue, which made $3.1 billion off OxyContin in 2010, still offers OxyContin sales incentives. The Enquirer obtained a Purdue email to a local doctor this year touting a discount program for the drug: “Eligible patients can save up to $90 on each prescription with the Savings Card, after paying the first $25.”