Bills would limit opioid prescriptions, invest in treatment options 

In an effort to tackle the opioid addiction epidemic, state legislators, Attorney General Bob Ferguson, and Democratic Governor Jay Inslee are rolling out legislation to limit opioid prescriptions and invest in drug treatment infrastructure.

On Jan. 12, the House Committee on Healthcare and Wellness heard public testimony on two bills that would limit the quantity of opioid pain medications that doctors and other providers can prescribe patients who are obtaining opioids for the first time—patients over the age of 21 could receive no more than a seven-day supply while those under 21 could obtain only a three-day dosage—and require that prescribers of opioids enroll in a state program to gather data and monitor opioid distribution to prevent over-prescribing. One bill would also require that providers notify patients obtaining more than a three-day supply of opioids of the risk of addiction.

While supported by the family members of those who have suffered from opioid addiction and law enforcement and public health officials, the bills were opposed by some worried about access to their pain medication as well as lobbyists for the medical community who were concerned about the burden it would put on doctors.

Both bills were requested by Ferguson, who argues that the limitations are necessary to prevent patients from getting addicted and keep excess pills out of medicine cabinets and in the hands of non-patients, and to make sure that all providers of opioids participate in the state’s Prescription Monitoring Program, which tracks patient prescription histories.

“The overprescribing of opioids has contributed to this problem which has swept across our state,” said Ferguson. “Despite the attention that this issue has received, over-prescribing is still happening.”

Only 35 percent of opioid providers in Washington currently participate in the voluntary Prescription Monitoring Program, according to Chris Baumgartner, drug systems director at the state Department of Health.

Gov. Inslee is moving on opioids as well: He’s requested a bill that prioritizes medication-assisted treatment—such as buprenorphine—for people suffering from opioid-use disorder, places medication treatment services at contact points such as prisons and syringe exchanges, and a first-in-the-nation Medicaid waiver to allow incarcerated individuals suffering from addiction to receive treatment. His supplemental budget also calls for investing roughly $15 million in medication-assisted treatment—including setting up drug treatment services at contact points such as jails.

Additionally, Inslee wants another $4 million for “prevention,” such as youth prevention efforts in rural communities. Specifically, the governor wants to increase the number of individuals in treatment by 20 percent each year over the next two years, a benchmark he called an “aggressive goal.”

“Two Washingtonians a day succumb to and lose life as a result of opioid addiction. And that is unacceptable,” Inslee said. “The state needs to step up.”

Starting in the early 2000s, reported deaths from prescription opioids rose dramatically before peaking in 2008, while deaths from heroin skyrocketed starting in 2010, according to state Department of Health data. Deaths from fentanyl—a prescription opioid pain medication that is significantly more powerful than heroin—have increased since 2015 as well. In 2016 alone, 694 people died from opioid overdoses, 446 of which were from prescription drugs. The governor and attorney general have emphasized over-prescribing of opiates by providers as being a major driver of opioid addiction in the state.

According to a report compiled by the Attorney General’s Office, Washington dentists prescribed the most opioids—roughly 13,000 pills for 13-19 year-olds during a six-month period in 2015—followed by emergency medicine providers. The report also indicated that Washington counties that experienced high prescription rates generally saw overlapping high rates of opioid overdoses in recent years.

However, the proposals aren’t without opposition. While the governor’s bill was relatively well received during a Senate public hearing earlier this week, the attorney general’s bills to limit opioid prescriptions and force providers to participate in the state’s monitoring program garnered significant pushback from the medical community and individuals suffering from chronic pain.

“Prescriber fear is at an all time high in our state,” said Cyndi Hoenhous, a member of Washington Patients in Intractable Pain, at a House hearing on Jan. 12.  “When it comes to opioid policy right now, providers don’t care about patients like me. Those in pain are now a liability.”

Katie Kolan, with the Washington State Medical Association, criticized the prescription monitoring mandate as redundant. The Health Department already has a stakeholder group discussing how to bring more providers into the monitoring program and general rules for prescribing opioids, she said. “While well-intentioned, this measure is duplicative and disruptive to efforts done by the state currently to implement the rule making and would preempt the department’s rule-making authority,” she said.

Another Washington State Medical Association representative and former state senator, Nathan Schlicher, said that poor integration of the monitoring program with the electronic health records system is burdensome for medical staff. “It’s bureaucracy as its finest,” he said, going on to call the program “poorly designed” and “poorly integrated.”

“If we do mandates like this it does take time away from patients,” Schlicher added.

Notably absent from the committee hearings on Ferguson’s restrictions on opioid prescriptions were pharmaceutical interests. However, PhRMA, a national association representing pharmaceutical companies including Purdue Pharma—the company that aggressively marketed oxycontin to the medical community and downplayed its addictive qualities in the 1990s and early 2000s, according to reporting by The New Yorker—supports the legislation and won’t be lobbying against either bill.

“We recently announced our support for policies that limit the supply of opioids to no more than seven days for patients with acute pain, a significant step for our industry … We also support strengthening and improving the state-run electronic databases that track prescribing of controlled substances,” a PHrMA spokesperson said.

Attorney General Ferguson is currently suing Purdue Pharma for deceptive marketing practices. (see additional article below)

People testifying in support of the attorney general’s bills had passionate responses to the concerns of patients in chronic pain and the medical community.

“It’s ridiculous. Honestly, this is the worst man-made epidemic in modern medical history and we’re talking about how much time it takes,” said Gary Franklin, the Department of Labor and Industries Medical Director. “These drugs are potentially deadly.”

“I know that these bills aren’t going to end this crisis but they can stem the flow of diversion if medicine cabinets aren’t full of leftover pills,” said Brenda Zane, whose 19-year-old son recently overdosed on fentanyl and survived. “I’ve heard a lot about inconvenience and burdens … how about $150,000 in medical costs? Those are burdens that I’m carrying. And my son lived … So we’re the lucky ones.”

– Josh Kelety, WNPA Olympia News Bureau

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Attorney Gen. Ferguson: New details unsealed in lawsuit against one of nation’s largest opioid manufacturers

Attorney General Bob Ferguson filed an unredacted complaint against Oxycontin maker Purdue Pharma, which reveals previously sealed details from the company’s internal documents. The newly released details describe the company’s interactions with several Washington state medical providers sanctioned for inappropriate prescribing of opioids. It also reveals an internal Purdue study that called into question information that the company used to deceive doctors into believing that opioids are effective for treating long-term chronic pain.

Ferguson filed his lawsuit against Purdue in September of 2017, accusing one of the nation’s largest opioid manufacturers of fueling the opioid epidemic in Washington state, embarking on a massive deceptive marketing campaign, and convincing doctors and the public that their drugs are effective for treating chronic pain and have a low risk of addiction, contrary to overwhelming evidence.Portions of Ferguson’s original lawsuit were sealed because Purdue contended the information about marketing and opioid safety was a trade secret. Ferguson filed a motion to unseal this information, which King County Superior Court Judge Catherine Moore recently granted.

“These newly unsealed details further illustrate the mechanics of Purdue’s massive deception,” Ferguson said. “Purdue ignored warning signs and their own studies while targeting high-prescribing doctors in Washington state. It’s time they are held accountable for the devastation this epidemic has caused.”

Some of the newly unsealed information is described below. The full complaint, with previously redacted portions highlighted, can be found here: http://agportal-s3bucket.s3.amazonaws.com/uploadedfiles/Another/News/Press_Releases/Compl_Highlighted.pdf.

Details revealed of Purdue’s marketing to high prescribers

A 2007 court order resulting from a consent judgment with Washington and 25 other states prohibited the company from making misleading statements regarding abuse, addiction or dependence in its marketing materials for OxyContin. Purdue also promised to create an Abuse and Diversion Detection Program to detect and take appropriate steps upon detecting “atypical” prescribing patterns.

Unsealed information in the complaint illustrates how Purdue’s sales staff collected data to aggressively market its drugs to the highest prescribers in the state, and failed to report questionable activity to authorities despite the 2007 court order.

Washington state medical boards sanctioned some of these prescribers for failing to follow rules related to opioid prescriptions and putting patients at risk. The lawsuit alleges that, in several cases, Purdue salespeople ignored red flags and continued to target these providers with sales pitches.

Some of the specific interactions that have been unsealed include:

– In late 2008, a Purdue sales representative filed a report with the company detailing allegations that the patients of Dr. Delbert Whetstone of Everett “are ‘all 20 year old thugs with diamonds in their ears and $350.00 tennis shoes who always pay cash.’” The company checked his prescription patterns and found that, in the six months previous to the report, Dr. Whetstone had written more than 1,000 OxyContin prescriptions worth nearly half a million dollars. Purdue did not report Dr. Whetstone to the DEA until 2011. Dr. Whetstone pled guilty to distribution of a controlled substance, among other charges, in 2012.

– Between 2007 and 2016, Dr. Donald Dillinger of Everett wrote nearly 10,000 prescriptions of OxyContin, 26 times more than the average Everett prescriber. Purdue increased its sales contacts with Dr. Dillinger beginning in 2007, nearly tripling contacts by 2011 when his OxyContin prescribing peaked. Purdue also recruited Dr. Dillinger to convince his peers to prescribe more opioids. Dr. Dillinger was disciplined by the state Medical Quality Assurance Commission in 2017 after “clear and convincing evidence” of improper treatment of patients with opioids.

– A sales representative reported that Dr. Frank Li, the owner and operator of Seattle Pain Centers, stated in 2010 that OxyContin “is very effective and works well but is misused and abused” and “he feels if he writes [too many prescriptions] people will start looking at his practice.” Seattle Pain Center’s opioid prescriptions were extraordinarily high. Between 2007 and 2016, Dr. Li alone wrote nearly 3,000 OxyContin prescriptions. Purdue did not report Dr. Li to authorities, and between 2010 and July 2016, when the state Medical Quality Assurance Commission suspended Dr. Li’s license, at least 60 Seattle Pain Center patients died, many of opioid-related causes.

– In addition to targeting high-volume doctors, Purdue identified nurse practitioners and physician assistants as “a high value target, particularly due to impact on primary care” and shifted its marketing strategy to emphasize these prescribers. From 2014 to 2015, Purdue tracked the 18 percent increase in prescribing by nurse practitioners and physician assistants. Purdue responded with increased marketing and attention on this group of prescribers.

False claims of the safety, effectiveness of long-term use

As shown in the original September complaint, Purdue aggressively promoted its opioids for chronic pain from conditions like headaches and low back pain, despite a lack of clinical evidence that they are effective and safe for long-term use. Contrary to Purdue’s marketing over more than two decades, the Centers for Disease Control & Prevention (CDC) noted in its 2016 guidelines that “there is no good evidence that opioids improve pain or function with long-term use.”

Purdue also falsely claims that opioids improve long-term function, have a low addiction risk that can be managed or prevented, and that increased doses of opioids do not pose significant additional risks to patients.

Unsealed information in the complaint includes a 2014 internal Purdue study, which noted that “more evidence of long-term effectiveness and safety is needed.” The study also noted that chronic pain management guidelines recommending the long-term use of opioids “are based on relatively weak or indirect evidence.”

Washington’s epidemic and Purdue’s sales force

Prescriptions and sales of opioids in Washington skyrocketed more than 500 percent between 1997 and 2011. In 2011, at the peak of overall sales in Washington, more than 112 million daily doses of all prescription opioids were dispensed in the state — enough for a 16-day supply for every woman, man and child in Washington. More than 18.2 million daily doses of oxycodone were distributed in Washington in 2015.

Newly unsealed information reveals that between 2009 and 2010, Purdue nearly doubled its sales force in Washington state. Between 2007 and 2016, Purdue sales representatives documented more than 210,000 visits to Washington prescribers. Nearly 34,000 of those visits were in 2011 alone.

Relief

Ferguson’s lawsuit seeks civil penalties, injunctive relief, and damages. Ferguson also asks the court to order Purdue to give up the profits it made in Washington as a result of its illegal conduct, believed to be in the millions.

The surrendered profits will be used to remediate the effects of Purdue’s misrepresentations of opioids, possibly funding treatment, education and more.

Assistant Attorneys General Tad Robinson O’Neill, Kate Barach, and Peter Helmberger are leading the case for Washington.

Ferguson’s work on the opioid epidemic

In June of 2017, the Attorney General’s Office hosted a summit on Washington’s opioid epidemic in partnership with the Washington State Patrol and the Washington Association of Prosecuting Attorneys.

A report developed by the organizations after the summit included a range of recommendations, three of which became the subject of Attorney General Request legislation for the upcoming 2018 legislative session. Ferguson has proposed bills to limit first-time prescriptions of opioids, and to require that doctors check the state’s Prescription Monitoring Program database for evidence of misuse or dangerous prescribing patterns before prescribing opioids. Ferguson is also proposing a third bill to give the Attorney General’s Office Medicaid Fraud Control Unit authority to issue search warrants and make arrests in Medicaid fraud cases, including those involving opioid misuse.

                        – Office of the Attorney General