The growing cluster of lawsuits argue that drugmakers set out to deceive doctors and the public by claiming their products presented little risk.

This article first appeared August 02, 2018 on Kaiser Health News.

By Fred Schulte

As Purdue Pharma faced mounting criticism over deaths linked to OxyContin, rival drugmakers saw a chance to boost sales by stepping up marketing of similarly dangerous painkillers, such as fentanyl, morphine and methadone, Purdue internal documents reveal.

Purdue’s 1996-2002 marketing plans for OxyContin, which Kaiser Health News made public this year for the first time, offer an unprecedented look at how that company spent millions of dollars to push opioids for growing legions of pain sufferers. A wave of lawsuits demanding reimbursement and accountability for the opioid crisis now ravaging communities has heightened awareness about how and when drug makers realized the potential dangers of their products.

The Purdue documents lay out how the company and its biggest competitors were jockeying for market share. Some of those drugmakers’ sales promotions downplayed or ignored the risks of taking opioids, or made false claims about their safety, federal regulators have asserted in warning letters to the companies.

Purdue first offered OxyContin as a remedy for moderate to severe cancer pain in 1996. Within three years, the company viewed the cancer market as too limited, with $261 million in potential annual sales versus $1.3 billion for a broader range of chronic pain care, the company’s marketing reports said.

“That was a pretty good recipe for a blockbuster,” said Andrew Kolodny, who directs Physicians for Responsible Opioid Prescribing, an advocacy group critical of drug industry marketing.

Purdue has become the most high-profile drugmaker linked to the surging opioid crisis. But other opioid manufacturers didn’t sit by idly as sales of OxyContin skyrocketed, topping $1 billion in 2000, despite reports of overdose deaths and addiction.

Purdue’s marketing reports indicate the company was worried about losing business to fentanyl-laced patches called Duragesic, as well as morphine pills and, to a lesser degree, methadone — which some managed-care groups and Medicaid health plans preferred because it cost much less than OxyContin. Methadone and morphine are made by a variety of drug companies.

In its 1999 marketing report, Purdue noted that Janssen Pharmaceuticals, an arm of drug giant Johnson & Johnson, was making “slow but steady” progress in promoting its Duragesic patches. The patches, which users attach to their skin, deliver a dose of fentanyl, an opioid drug about 50 to 100 times more powerful than morphine, according to the Drug Enforcement Administration.

Purdue estimated that Janssen would spend about $4 million in 1999 on medical journal advertising to persuade doctors to prescribe the patches for “early treatment of non-cancer pain and pain in the more frail elderly.” That is more than triple what Janssen spent the year before, according to the 2000 Purdue marketing report. In a statement to KHN, a Janssen spokesman said the company quit “actively marketing” Duragesic in 2008.

Purdue also spent millions on medical journal ads — and like Janssen, it drew criticism from the Food and Drug Administration for minimizing the dangers of opioids, government records show.

In 2000, the Food and Drug Administration criticized Purdue for exaggerating the benefits of using OxyContin to treat arthritis, while in 2003 the agency found that some other ads had “grossly overstated” OxyContin’s safety.

Janssen also drew the ire of the FDA. In March 2000, the agency called some claims made for Duragesic “false or misleading,” including the suggestion that the drug “has less potential for abuse than other currently available opioids.”

In September 2004, the FDA told Janssen to “immediately cease” making “false or misleading” claims, including saying that Duragesic was “less abused than other opioid drugs.” In its statement to KHN, Janssen said its marketing actions were “appropriate and responsible,” adding that it “acted quickly to investigate and successfully resolve FDA’s inquiries.”

The Purdue marketing reports are part of a cache of documents the company provided to the Florida attorney general’s office in 2002. The Florida attorney general released them to two Florida newspapers in 2003 after Purdue lost a court battle to keep them under wraps.

More than 1,500 groups, mostly cities, counties and states, are suing Purdue Pharma, Janssen and several competitors and drug distributers in federal court in Cleveland demanding reimbursement for treatment costs and other compensation. In a statement to KHN, Purdue said: “We vigorously deny these allegations and look forward to the opportunity to present our defense.”

The growing cluster of lawsuits argue that drugmakers set out to deceive doctors and the public by claiming their products presented little risk.

For its part, Purdue accused Janssen of trying to exploit public alarm over OxyContin-linked deaths to spark new sales of Duragesic.

“It has been reported that Janssen sales representatives are using improper techniques to capitalize on the negative press surrounding OxyContin Tablets and the issue of abuse and diversion,” reads the 2002 Purdue marketing plan.

In fact, opioids made by Purdue’s rivals also contributed to overdose deaths in those years and have continued to do so. In 2016, more than 42,000 people died nationwide from opioid-related causes, according to the Department of Health and Human Services.

Florida was one of the early states to see a rise in overdose deaths tied to prescription drugs. Florida medical examiner’s toxicology reports in 2002 detected oxycodone, the active ingredient in OxyContin, in hundreds of overdose fatalities. Abusers realized they could crush the pills and inject or snort the powder to get high. Many others died after mixing the pills with sedatives also prescribed by their doctors.

Florida medical examiner files also showed that abuse of fentanyl pain patches, methadone and morphine took many lives. Some abusers had figured out how to drain the Duragesic patch of its liquid fentanyl and inject it like heroin, or otherwise ingest it.

In July 2005, the FDA warned health care professionals about abuse of fentanyl patches. In December 2007, FDA cited reports of deaths and “life-threatening adverse events” when the fentanyl patch “was used to treat pain in opioid-naïve patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently and exposed the patch to a heat source.”

Purdue also kept an eye on methadone, noting in a 1999 marketing plan that “market research as well as reports from the sales force indicates that methadone use is increasing in both the management of cancer pain and non-malignant pain due to its low cost.” But as methadone won acceptance for treating pain, it also began to kill with alarming frequency.

The FDA in November 2006 warned of deaths and dangerous side effects among patients “newly starting methadone for pain control and in patients who have switched to methadone after being treated for pain with other strong narcotic pain relievers.”

Many doctors predict that the proposed payment changes would establish a financial incentive to see fewer Medicare patients.

This article first appeared July 31, 2018 on Kaiser Health News.

By Martha Bebinger, WBUR

The Trump administration announced a plan Friday that would affect about 40 percent of the payments physicians receive from Medicare. Not everybody's pleased.

The Centers for Medicare & Medicaid Services calls its proposed plan a historic effort to reduce paperwork and improve patient care. But some doctors and advocates for patients fear it could be a disaster.

The CMS plan, published in Friday's Federal Register, is now open for public comment until early September. It would combine four levels of paperwork required for reimbursement, and four levels of payments, into one form and one flat fee for each doctor's appointment (although there would still be separate filing systems for new and established patients).

In a letter previewing the plan to doctors earlier this month, CMS Administrator Seema Verma said that physicians waste too much time on mindless administrative tasks that take time away from patients.

"We believe you should be able to focus on delivering care to patients," Verma wrote, "not sitting in front of a computer screen."

Initially, that sounded pretty good to Dr. Angus Worthing, a rheumatologist in Washington, D.C. Then he tested the claim with his own analysis.

During a typical 15- to 45-minute appointment with a patient, Worthing figured, "I might spend one to two minutes less in front of the computer, documenting and typing."

Dr. Kate Goodrich, CMS' chief medical officer, noted that "saving one to two minutes per patient adds up pretty quickly over time."

But Worthing said the small savings in time is not worth the reduced payment he'd get. The CMS plan would offer a flat fee for each office visit with a patient, whether the doctor is a primary care physician or a specialist.

Rheumatologists, in general, could expect a 3 percent reduction in Medicare's reimbursement because they typically see and bill for more complicated patients, said Worthing, who chairs the government affairs committee for the American College of Rheumatology.

And he noted that his personal net income from Medicare patients would drop even more — by about 10 percent. That's because 70 percent of his costs — for rent, payroll and other expenses — are fixed or rising.

Worthing is leading efforts by rheumatologists to persuade CMS to adjust its funding formula before the plan goes into effect in January.

"The proposal is well-intentioned but it might cause a disaster," he said, if it leads to fewer medical students going into rheumatology and other specialties that require doctors to manage complex patients. And physicians might stop taking Medicare patients altogether, or avoid those with more difficult problems.

Al Norman, a 71-year-old Medicare patient, said he can see that disaster coming.

"If you're frail or if you are very healthy, you're worth the same to a doctor [under the proposed plan], and obviously that means that the people who are more disabled or frail are less desirable patients," said Norman, who worked on elder care issues in Massachusetts before retiring last year.

Many doctors predict that the proposed payment changes would establish a financial incentive to see fewer Medicare patients. Goodrich, the Medicare official, disagrees.

"That's an unintended consequence we wanted to mitigate on the front end and avoid," Goodrich said. Under the proposed system, doctors who need more time with patients could file for an "add-on" payment of $67 per appointment. That would require a small amount of additional documentation, she admitted, but would still reduce a doctor's keyboard time, according to CMS estimates.

This "add-on" payment is "intended to ensure that physicians are being appropriately compensated for seeing the most complex patients," Goodrich said.

Still, critics of the plan say there are other unintended consequences CMS may not have anticipated.

Dr. Paul Birnbaum, who has been practicing dermatology in the Boston area for 32 years, said he's worried that paying doctors a reduced fee per appointment would translate to lots of short visits.

"You would just see more people," Birnbaum said. "You'd move people through faster. And so you have somebody come back for repeat office visits. And that, over time, would be inflationary."

More frequent trips to the doctor would mean more copays for patients and higher costs for Medicare, he said.

The Trump administration is not suggesting the payment changes would save Medicare money. In her letter to doctors, Verma said some physicians would see their Medicare payments increase.

And it's not just doctors who treat elderly patients who are likely to be affected. If the Medicare payment changes take effect, private insurers might follow suit, in part because it's easier for all insurers to use common billing procedures.

Theoretically, obstetrician-gynecologists would be among the biggest winners; they treat fewer complex Medicare patients. Still, many OB-GYNs are worried about the coming changes, too.

"There will be winners and losers, and my real fear is it's not the physicians [who will lose the most]. My real fear is that it's the Medicare beneficiaries," said Dr. Barbara Levy, vice president for health policy at the American College of Obstetricians and Gynecologists.

Some Medicare advocates are urging CMS to postpone these changes and consider a trial run.

"If we're going to talk about this kind of wholesale, large-scale reconfiguration of the way reimbursement is given to doctors," said Joe Baker, president of the Medicare Rights Center, "it's probably best to do that in a demonstration project where we can closely study the ramifications."

CMS hopes to enact any changes to Medicare fee schedules on Jan. 1, 2019.

The main challenge remains convincing patients and physicians that the changes are worth doing in the first place.

PhRMA donated $6.1 million in 2016 to the American Action Network, which ran anti-ACA TV ads in 75 congressional districts.

This article first appeared July 30, 2018 on Kaiser Health News.

By Jay Hancock

In 2010, before the Affordable Care Act was passed by Congress, the pharmaceutical industry's top lobbying group was a very public supporter of the measure. It even helped fund a multimillion-dollar TV ad campaign backing passage of the law.

But last year, when Republicans mounted an aggressive effort to repeal and replace the law, the group made a point of staying outside the fray.

"We've not taken a position," said Stephen Ubl, head of the organization, the Pharmaceutical Research and Manufacturers of America, known as PhRMA, in a March 2017 interview.

That stance, however, was at odds with its financial support of another group, the American Action Network, which was heavily involved in that effort to put an end to the ACA, often referred to as Obamacare, spending an estimated $10 million on an ad campaign designed to build voter support for its elimination.

"Urge him to repeal and replace the Affordable Care Act now," one ad running in early 2017 advised viewers to tell their congressman. That and similar material (including robocalls) paid for by the American Action Network ran numerous times last year in 75 congressional districts.

PhRMA was one of AAN's biggest donors the previous year, giving it $6.1 million, federal regulatory filings show. And PhRMA had a substantial interest in the outcome of the repeal efforts. Among other actions, the GOP-backed health bill would have eliminated a federal fee paid by pharmaceutical companies, one estimated at $28 billion over a decade.

But there was no way the public could have known at the time about PhRMA's support of AAN or the identity of other deep-pocketed financiers behind the group.

Unlike groups receiving its funds, PhRMA and similar nonprofits must report the grants in their own filings to the Internal Revenue Service. But the disclosures don't occur until months or sometimes more than a year after the donation.

The conservative-leaning AAN has become one of the most prominent nonprofits for funneling "dark money" — difficult-to-trace funds behind TV ads, phone calls, grass-roots organizing and other investments used to influence politics. Such groups have thrived since the Supreme Court's Citizens United decision in 2010, which loosened rules for corporate political spending, and amid what critics say is nonexistent policing of remaining rules by the IRS.

(It's impossible to know from public records whether PhRMA donated before or after President Donald Trump's victory, which made repealing the health law a substantial possibility. In any case, most donations to dark-money groups are not earmarked for a particular program.)

Generally speaking, dark-money groups are politically active organizations, often nonprofits, that are not required to disclose identities of their donors. Under IRS regulations, donors may fund a nonprofit group such as AAN, which is allowed to engage in political activities and is not required to reveal its funding sources.

Dark-money groups are often chartered under Section 501(c)(4) of the tax law, which grants tax exemption to "social welfare organizations." For those seeking to influence politics but stay in the background, 501(c)(4) designations offer two big advantages: tax exemption and no requirement to disclose donors.

Against the backdrop of high drug prices and its heaviest political expenditures in years, the pharmaceutical industry is directing substantial resources through AAN and other such groups that hide the identity of their donors and have few if any limits on fundraising.

"PhRMA has always been very aggressive and very effective in their influence efforts," said Michael Beckel, research manager at Issue One, a nonprofit devoted to campaign-finance transparency. "That includes using these new, dark-money vehicles to influence policy and elections."

PhRMA's $6.1 million, unrestricted donation to AAN was its single-biggest grant in 2016, dwarfing its $130,000 contribution to the same group the year before. Closely associated with House Republicans — AAN has a former Republican senator and two former Republican House members on its board — the group backed the failed GOP health bill intended to replace the Affordable Care Act. It also supported the successful Tax Cuts and Jobs Act of 2017, which reduced corporate taxes by hundreds of billions of dollars over a decade.

So far in this election cycle, AAN has given more than $19 million to the Congressional Leadership Fund, a Republican super PAC with which it shares an address and staff, according to the Center for Responsive Politics. The fund recently ran ads opposing Democratic candidates in high-profile special congressional elections in Georgia and Pennsylvania.

PhRMA disputes the suggestion that it backs particular actions by the recipients of its donations. "PhRMA engages with groups and organizations that have a wide array of health care opinions and policy priorities," said its spokesman, Robert Zirkelbach. "It is inaccurate and would be inappropriate for you to attribute those grants to a specific campaign."

AAN declined several requests for comment.

Including AAN, PhRMA gave nearly $10 million in 2016 to politically active groups that don't have to disclose donors, its most recent filing with the IRS shows. By contrast, PhRMA and its political action committee, or PAC, made only about $1 million in comparatively transparent political donations in 2015 and 2016 that were disclosed to regulators and reported by the Center for Responsive Politics.

PhRMA's 2016 political activities included support for the Republican National Convention. Rather than directly support the Cleveland convention, which several companies pulled out of after it became clear that Donald Trump was going to be the presidential nominee, PhRMA routed $150,000 through limited liability companies with names like Convention Services 2016 and Friends of the House 2016.

Like 501(c)(4)s, LLCs do not have to disclose their donors. PhRMA's support was revealed in IRS filings more than a year later. (Donations by PhRMA and other groups to Friends of the House, which financed a luxury lounge for convention dignitaries, were first reported by the Center for Public Integrity last fall.)

PhRMA's surge in donations to AAN coincides with the arrival of Ubl, who took over as president and CEO in 2015 and has long-standing ties to Norm Coleman, a former U.S. senator from Minnesota who is now AAN's chairman. Ubl once ran the lobby for makers of knee implants, heart stents and other medical devices, one of whose most powerful members, Medtronic, is based in Minneapolis.

Dues paid by member drug companies rose by 50 percent after he got there. PhRMA's total revenue increased by nearly a fourth in 2016, according to IRS filings.

PhRMA's 2016 dark-money contributions included $150,000 to Americans for Prosperity, a conservative group associated with billionaires Charles and David Koch. Their group has already signaled it will be active in November's elections, running attack ads against Sen. Jon Tester, a vulnerable Montana Democrat, for not supporting ACA repeal.

PhRMA also gave $50,000 to Americans for Tax Reform, run by conservative anti-tax activist Grover Norquist.

PhRMA and other trade associations donate to such groups "to avoid attracting attention" amid the political fray, said Bruce Freed, president of the Center for Political Accountability, which seeks to shed light on corporate political spending. Nevertheless "they're achieving their goals by giving money to these folks and helping elect members that are going to be in support of them."

Mostly smaller amounts went to centrist and liberal groups. Center Forward, which claims to seek bipartisan, common ground on drug policy and other issues, got $300,000 directly from PhRMA and another $179,000 from a PhRMA-backed group called the Campaign for Medical Discovery, according to tax filings.

Zirkelbach disputed the notion that PhRMA donations to AAN and other groups were intended to achieve specific goals, saying, "We seek to work with organizations we agree with as well as those where we have disagreements on public policy issues."

Much of the work by PhRMA-linked, dark-money groups touches health policy and harmonizes with PhRMA's positions.

During debates over the tax overhaul, Center Forward worked to preserve a tax credit for researching rare-disease medicines known as orphan drugs. PhRMA took a similar stance, encouraging Congress "to maintain incentives" for rare-disease drugs.

AAN, which collected total contributions and grants of $14.6 million for fiscal 2016, launched a $2.6 million mass-mailing and ad campaign against letting Medicare lower drug prices through negotiations. PhRMA supported that stance, telling Healthline that such a measure could jeopardize seniors' access to medicine and discourage companies from developing drugs.

Americans for Tax Reform ran similar ads in local markets opposing "price controls" on prescription drugs.

PhRMA's dark-money allies push its agenda without disclosing its role, critics say.

PhRMA is "spending millions of dollars on politics every cycle, and they're splitting it up between the state and federal level," said Robert Maguire, political nonprofits investigator for the Center for Responsive Politics, which tracks political donations. "They're just not running the political ads themselves," which keeps their name off the product, he said.

A group called Caregiver Voices United, which got $720,000 from PhRMA in 2016, backed a secret effort to generate letters opposing a drug-transparency bill in Oregon. The campaign surfaced when an employee leaked phone-script documents to a lawmaker, as reported in February by The Register-Guard newspaper in Eugene.

Caregiver Voices United is "not influenced" by PhRMA or any other outside group, said John Schall, its president.

Dark-money groups received pharmaceutical industry money from individual companies as well, not just the PhRMA trade organization.

In 2016, Amgen gave $7,500 to Third Way, a center-left group that supports reimbursement for drugs and medical devices based on their results, according to the Center for Political Accountability. Johnson & Johnson gave $35,000 that year to the Republican Main Street Partnership, a 501(c)(4) that describes itself as a coalition of lawmakers committed to "conservative, pragmatic government," the CPA data show.

But CPA's research also reveals that many pharmaceutical companies don't disclose donations made to 501(c)(4) organizations, nor are they legally required to.

Corporations "could dump millions into one of these (c)(4)s and nobody would ever know where it came from," said Steven Billet, a former AT&T lobbyist who teaches PAC management at George Washington University.

About 88% of sex-trafficking survivors say that, while they were being trafficked, they had contact with a healthcare provider.

This article first appeared July 24, 2018 on Kaiser Health News.

By Michelle Andrews

The woman arrived at the emergency department at Huntington Hospital on New York's Long Island after she was hit by her boyfriend during an argument. Her situation raised concerns among the medical staff, which had recently been trained to be on the lookout for signs of sex trafficking.

An undocumented immigrant from El Salvador, she worked at a local "cantina" frequented by immigrants. Her job was to get patrons drinks and to dance with them, but many workers in those jobs are expected to offer sex, too. Her boyfriend didn't want her to work there, and that led to the fight, one doctor recalled.

As part of the intake process, the emergency staff asked the 36-year-old woman a series of questions about whether she'd ever had sex for money, or whether she had to give someone else part of what she earns, among other things. The screening questions were part of a new program at Northwell Health, a 23-hospital system in the New York metro area that includes Huntington Hospital, to train staff and provide them with tools to identify and support victims of human trafficking.

There are no hard figures for how many people are involved in human trafficking, the term used when individuals are forced to work or have sex for someone else's commercial benefit. Polaris, a Washington, D.C.-based nonprofit that advocates for these people and runs help lines for them, said calls and texts to its national hotlines have steadily ticked up in recent years, increasing the number of cases 13 percent between 2016 and 2017, to 8,759.

But health care providers frequently fail to recognize these patients' situation. According to a 2014 survey of about 100 survivors of sex trafficking, 88 percent said that while they were being trafficked they had contact with a health care provider, typically someone in an emergency department.

"When trafficking victims come through the health care system but we don't identify them, it's a big missed opportunity," said Dr. Santhosh Paulus, a family physician who is the site director of the Huntington Hospital's family medicine residency program and who started the program at Northwell.

Northwell is one of a growing number of hospitals and health care systems that are putting such programs in place. They want to alert staff to be on the lookout for trafficking, much as they watch for signs of child abuse, domestic violence and elder abuse.

Since last spring, nearly 300 staff members at Huntington Hospital and a family clinic have received training in how to spot trafficking victims and how to help them.

Training is given not only to doctors and nurses but also to registration and reception staff, social workers and security guards. Restore NYC, an organization that assists people caught up in sex trafficking, provided the initial training to key staff, and a hospital task force trains the others. During the next few years, similar efforts will be rolled out at all of Northwell's 23 hospitals, Paulus said.

Identifying victims of trafficking is not unlike identifying victims of other forms of violence, said Dr. Wendy Macias-Konstantopoulos, director of the human trafficking initiative at Massachusetts General Hospital.

One of the big red flags is when people delay coming in for medical care, such as waiting weeks to come in to get an injured ankle or sexually transmitted infection checked out, Macias-Konstantopoulos said. Or it may be a pattern of injuries that don't make sense. Sometimes people are reluctant to explain their injury, or they come in with someone who seems overbearing.

"Having a high index of suspicion is the first step," she said. "If we're not asking about it, we're just not going to see it."

Starting in October, health care providers can also use new diagnosis codes in their records that differentiate trafficking from other types of abuse. This will help track the number of victims and provide appropriate treatment.

Asking may not be enough, however. Depending on what's going on in their lives, these patients may not be willing or ready to acknowledge that they need help, said Holly Gibbs, human trafficking response program director for Dignity Health, a health care system with nearly 40 hospitals in California, Nevada and Arizona.

Gibbs knows the issue well. She was forced briefly into prostitution in Atlantic City, N.J., after meeting a man at a shopping mall as a 14-year-old and running away with him. The man persuaded Gibbs to go with him with promises of a new, glamorous life as a musician or model. At the time, Gibbs said, she thought that what happened to her was her own fault, a result of choices she made. No health care or law enforcement professional connected her to social services that could have helped her understand otherwise. She was reunited with her family by law enforcement personnel, who arrested the man. He was was later convicted.

Dignity Health has implemented a human trafficking response program in the emergency departments and labor and delivery areas of each of its hospitals. Now it's rolling out the program at clinics and physicians' offices as well.

A key priority is to help clinicians know how to talk to patients about any violence they may be facing and to connect the patients with outside sources of help.

But in the end, if these patients don't want assistance, "you respect their wishes," Gibbs said. "They may not be ready to accept help now, but you may plant seeds so they'll be able to accept it later on."