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Groups unite against curbing painkillers

Industry, doctors, patients lobby over opiate laws

Cindy Steinberg advocates for patients with pain.Handout

Not everyone cheered Massachusetts state senators this year when they tried to strike a blow against an epidemic of prescription painkiller abuse and overdose deaths.

In some quarters, it was seen as an affront.

“MA state senators’ message is clear to MA residents living with pain . . . we don’t care about you!” tweeted Cindy Steinberg, an advocate for patients who depend on prescription opiates to manage pain.

A frequent presence in Washington and on Beacon Hill, Steinberg has deep knowledge of prescription narcotic regulations and a certain personal credibility. To relieve her own severe back pain, the result of an office accident in the 1990s, she lies flat on her back during legislative hearings.

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Steinberg’s reaction to this year’s Massachusetts Senate bill captured the emotional core of lobbying campaigns against strict curbs on opiate prescribing, both nationally and in state capitals. Those campaigns are funded in part by drug makers.

Their message: Don’t punish millions of legitimate pain patients in the rush to reduce prescription opiate addiction.

The industry is working to protect its US market for oxycodone, hydrocodone, and similar drugs, which reached $8.3 billion in 2013. Its opposition to stricter access restrictions on its drugs is often echoed by a network of allies, including industry-backed patient groups such as the US Pain Foundation, where Steinberg is the national policy and advocacy director.

Locally, Steinberg has teamed with another powerful organization that also opposes some of the strictest narcotic prescribing proposals: the Massachusetts Medical Society, which represents the state’s physicians.

This sort of organized resistance from the patient and medical community frustrates elected leaders and public health officials who are trying to devise measures to curb a wave of narcotic painkiller abuse and overdoses that claimed 16,500 lives across the country in 2010.

“There’s an imbalance, an unevenness in the view of the benefits of these products versus the dangers,” said Representative Bill Keating, the Bourne Democrat who has introduced a bill in Congress to require that opiate pills be manufactured in a way that makes them difficult to crush and then snort or inject.

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“What about the pain of someone’s spouse or loved one or daughter, and they are dead? That is a pain that doesn’t go away,” Keating said.

Law enforcement leaders say prescription opiates serve as a gateway to heroin, which has been responsible for a shocking surge in deaths in New England recently. Massachusetts alone experienced 58 heroin overdose deaths in the first half of December, State Police said.

To be sure, drug companies and advocacy groups recognize the serious toll of addiction and strongly support a variety of measures to fight it. For example, they favor the expenditure of public funds for treatment programs and physician education on the warning signs of abuse. They also support greater availability of emergency drugs that can save people who have overdosed. They favor abuse-resistant pills, which are difficult for addicts to crush.

The groups also broadly support prescription drug monitoring programs that allow doctors and pharmacists to check computer networks, which can reveal whether patients are getting multiple prescriptions from different providers, a typical indication of abuse.

But there is disagreement about how often doctors should be required to log on and do searches on those computers. The state Senate and the state Department of Public Health in 2014 proposed making the checks mandatory and more frequent.

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Steinberg, however, said those measures unfairly penalize patients who are in pain by adding hurdles to access.

“That side of things has been so overlooked in this frenzy of abuse and overdoses,” Steinberg said. “Everyone has forgotten all these millions of Americans who are living with pain.”

When she is not flat on her back, Steinberg is making YouTube videos, writing letters to public officials, or e-mailing pain patients around the country. She is the public face of a local volunteer group called the Massachusetts Pain Initiative.

She also is a leader of the US Pain Foundation, a Connecticut-based nonprofit that received 87 percent of its $250,000 budget from prescription drug companies in 2012. Steinberg was paid $6,480 by the US Pain Foundation in 2012 for her role, according to tax records. She received the same amount from the group in 2013.

The US Pain Foundation, in turn, is one of a handful of industry-funded groups seeking to influence state and Washington policy makers. Most of the organizations disclose that they receive money from drug companies, but they stop short of disclosing amounts.

Steinberg said the payments she receives from the US Pain Foundation do not influence the positions she takes as a volunteer advocate speaking to lawmakers and public officials: “Am I motivated because a pharmaceutical company told me to say anything? No.”

But critics say industry-funded influence on both government and the medical community has had a profound effect on the prescription drug crisis in New England and across the United States, fueling overprescribing of addictive drugs such as OxyContin, Percocet, and Vicodin.

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Cheryl Bartlett, the state commissioner of public health until this month, said drug abuse is a serious problem. “It’s a scary combination of things that have taken us to a place that it is really overwhelming our health care system,” she said.ARAM BOGHOSIAN FOR THE BOSTON GLOBE/FILE 2014/Globe Freelance

Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, a nonprofit group, would not name specific organizations but said the debate has been heavily influenced by “front groups” that “exist to take money from industry and [that] service industry needs.”

The industry and its representatives, Kolodny added, “will support everything but reductions in prescribing.”

The prescription painkiller industry received a black eye in 2007 when Purdue Pharma, the maker of OxyContin, and three of its executives pleaded guilty to misleading regulators and physicians about the addictive qualities of the drug. The company paid a $600 million penalty.

That did not end controversy surrounding the expansive market penetration of potent pain pills. The city of Chicago this year filed a detailed civil lawsuit alleging deceptive marketing practices by Purdue Pharma, Teva Pharmaceutical Industries, and other prescription opiate manufacturers. The suit alleges that companies worked closely with a variety of nonprofit groups and allied physicians, despite the hazards of addiction, to dramatically boost painkiller prescribing in the late 1990s and early 2000s.

Teva Pharmaceutical declined to comment on the lawsuit. Purdue Pharma dismissed its effects.

“As widely documented, these lawsuits are designed to enrich trial attorneys, not improve public health,” Purdue Pharma said in a statement.

“Purdue actively discourages the misprescribing and overprescribing of our medications,” it added. In addition to partnering with patient advocacy groups, it said, it also has joined law enforcement officials and addiction experts to combat abuse.

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The wave of opiate addiction in the last decade is undeniable. As stated in the Chicago lawsuit, a key turning point came in 2000, when, with the backing of an industry-funded study group in Wisconsin, the organization that accredits US hospitals recognized pain as the “Fifth Vital Sign” that should be treated aggressively.

That change dovetails with another recent trend. Patients now are routinely asked to rate hospitals and physicians on, among other things, how well they treat pain. Under new pay-for-performance compensation systems for doctors and hospitals, those ratings are used to help calculate compensation.

The upshot is doctors’ paychecks are being affected by whether or not they prescribe pain pills, said Cheryl Bartlett, who was the Massachusetts commissioner of public health until this month.

“People are saying their child is going in for a sore throat and getting a narcotic pain prescription. People are going in for a routine dental extraction and getting a 30-day supply of a narcotic,” Bartlett said.

Specialists say some of those patients have a genetic predisposition to addiction and get hooked on the pills. Nationally, the Centers for Disease Control and Prevention estimates prescription drug abuse costs have soared to about $72 billion a year.

“It’s a scary combination of things that have taken us to a place that it is really overwhelming our health care system,” said Bartlett, whose agency proposed mandates on prescribing physicians similar to the Senate’s.

But such restrictions go against the grain for many doctors who say they know what’s best for their patients. Even doctors who battle addiction on the front lines of the epidemic don’t believe physicians should be required to frequently check medication histories of their patients.

“I don’t think you can put all of the onus on doctors. There are pill mills, but for the majority of the doctors, it’s not going to turn out they are the problem,” said Dr. Edward Bernstein, an expert on addiction who coordinates substance abuse treatment and referrals in the emergency room at Boston Medical Center. “That is what we went into medicine for, to alleviate pain and suffering.”

With her own tale of persistent pain, Steinberg, a resident of Lexington, is a dramatic spokeswoman for her side of the debate. The former technology executive suffered nerve and ligament damage in 1995 when, in her office near Harvard Square, she was struck by a toppling file cabinet. It left her with debilitating back pain; prescription opiates, non-narcotic drugs, and physical therapy helped ease the pain, but it has never gone away completely.

Her odyssey opened her eyes to another problem: Patients complaining of pain are often not believed by doctors. She started a support group in her local library. She became an activist for better access to pain drugs.

“What I learned is that this is helpful for many people, and most people with pain do not feel any high from the medication, and they do not get addicted to it,” she said. “It was like an awakening to me.”

In 2013, Steinberg was among the patient advocates who testified against the FDA’s plan to stiffen limits on hydrocodone. The changes sharply limit refills and require patients to see their doctor and personally bring their prescription to a pharmacy, rather than permitting a doctor to phone or fax it in. Such changes were long overdue, some said.

Steinberg also publicly opposed Governor Deval Patrick’s ban this year on Zohydro, a high-dose hydrocodone drug that was approved by the FDA over furious objections from addiction specialists and despite a negative recommendation from its own advisory panel. Patrick’s decision was promptly overturned by a US District Court judge.

In September, Steinberg participated in a “Chronic Pain Community Expert Roundtable” conference call sponsored by Zohydro’s manufacturer, Zogenix, describing the negative experiences of patients with pain. She said she received no compensation. The US Pain Foundation said it received about $6,000 in 2014 from Zogenix.

After the Massachusetts Senate unanimously passed its bill to crack down on opiate abuse in May, the measure went to the House, where Steinberg said she and the Massachusetts Medical Society lobbied to soften some of its provisions.

“We believed the initial drafts of the [prescription monitoring program] legislation were overly broad and would have impeded seriously ill patients from receiving adequate medications in a timely fashion,” the Medical Society said in a statement. It said it has always broadly supported the monitoring program since its inception in 1992.

Representative Elizabeth A. Malia of Jamaica Plain, chairwoman of the Joint Committee on Mental Health and Substance Abuse, was among House lawmakers who recognized those concerns. When the House bill emerged in the summer, requirements that insurance companies pay for treatment remained. The mandate that doctors regularly check their patients’ prescription histories for signs of abuse was gone.

“There was a lot of discussion about that, to not make that more difficult for people who have legitimate need to get the meds,” Malia said.

Those changes were part of the final bill that passed and was signed by Patrick.

The debate promises to continue. Governor-elect Charlie Baker, in a post-election interview with the Globe last month, said targeting prescription opiate abuse will be a major priority during the first six months of his administration. He said he was shocked that a doctor prescribed narcotic painkillers for his son after he broke his arm playing football. Baker said during his campaign that he supported a mandate that prescribers check prescription histories of their opiate patients annually.

The new governor can expect Cindy Steinberg to chime in. In fact, she already has, responding to Baker’s remarks in the Globe with a detailed post on public radio station WBUR’s website.

“What are people with pain supposed to do?” Steinberg told the Globe in an interview last week. “All they are asking is to be included in the conversation.”


Christopher Rowland can be reached at crowland@globe.com. Follow him on Twitter @GlobeRowland.