Back in March, the organization has kicked-off a multi-million dollar campaign against the pharmaceutical industry. Since then they’ve stormed lawmakers’ offices, ramped up their ad campaigns, and even rented planes to fly over beaches. “I can’t really think of another time when there’s been this strong a message in opposition to an entire industry,” said John Rother, the group’s former head of policy.
Medical records have become a hot target for hackers looking for troves of data. ProPublica launched an investigation into just how easy the servers are to breach. Meanwhile, a San Diego couple is being charge with stealing trade secrets allegedly to use the information to market their biotech company.
In the 15 years since she lost her son to a single OxyContin pill, Barbara Van Rooyan has had but one up-close look at the people representing the company that made it.
It was in a small courthouse in Abingdon, Va., where Van Rooyan and other relatives of OxyContin victims gathered for a sentencing hearing in 2007. Three executives of Purdue Pharma had pleaded guilty to federal charges related to their misbranding and marketing of the powerful opioid. The company had pleaded guilty as well.
Van Rooyan and the others in her group spoke during the sentencing, giving voice to their grief and their pain. They wanted the executives sent to jail for knowingly expanding an opioid crisis fast engulfing the country.
Instead, Purdue paid fines totaling $634 million. The executives served no time. The company was allowed to continue aggressively marketing its product, and the following year, sales of OxyContin reached $2 billion.
From 1999 to 2017, more than 700,000 people in the U.S. died of drug overdoses, according to the Centers for Disease Control and Prevention. In 2017, nearly 68% of the more than 70,000 recorded overdose deaths involved opioids.
“I never really thought a whole lot about evil before this all happened,” Van Rooyan said recently, seated on a couch in the living room of her Irvine, Calif., home. “But to see this kind of malevolence or disregard for human life — I don’t know what else to call it but evil.”
The outcome in that Virginia courthouse was a far cry from last week’s news of a tentative mass settlement of many of the 2,000-plus lawsuits against the company, which could total upward of $12 billion and result in Purdue’s dissolution.
The potential settlement amount would include $3 billion from the Sackler family, owners of Purdue, whose fortune is estimated at $13 billion. The family has amassed that money over the past two decades, largely by selling OxyContin, an opioid painkiller.
Van Rooyan’s Purdue experience is a story of deception, sadness and frustration — yet when she tells it now, she emits a surprising spark of energy. That’s because Van Rooyan, part of the unlikely group of citizens who repeatedly took flailing swings at Purdue Pharma, is watching the giant fall.
Van Rooyan, who has studied the cases against Purdue closely, sees the paradox in the proffered settlement: Much of the payout would be financed by profits from the continued sale of OxyContin, under a new company that would be formed following a Chapter 11 bankruptcy.
But in some regard, she said, Purdue Pharma’s complicity in the opioid crisis has finally emerged into the general public’s view. “The world really knows now. They get it,” she said. “The lid is off, and all this stuff is bubbling out.”
That wasn’t the case on the night of July 4, 2004, when Van Rooyan and her husband, Kirk, got the call that changed their world. Barbara, then a professor of counseling at Folsom Lake College near Sacramento, was told that her son, Patrick Stewart, lay in a San Diego hospital, in a medically induced coma from which he was unlikely to emerge.
Patrick, a graduate of Oak Ridge High School in El Dorado Hills, Calif., and San Diego State University, died at age 24. His friends told Barbara they had attended an Independence Day party at which someone offered her son an OxyContin pill, telling him it “was kind of like a muscle relaxant and it was FDA approved, so it was safe,” she said. Patrick, who had also consumed a couple of beers, was opioid intolerant and suffered respiratory failure in his sleep.
“At the time,” Van Rooyan said, “all I knew about Oxy was that Rush Limbaugh had been addicted to it.”
She was about to learn a lot more.
Van Rooyan channeled her grief through intense research into Oxy’s vast potential for damage despite the company’s sales pitches to the contrary. A slow-release pain treatment with a heavy dose of the narcotic oxycodone, it could be easily crushed or dissolved for a more intense and addictive high. Rampant abuse already had begun to be reported, particularly in the Appalachian area, author Beth Macy wrote in her national bestseller “Dopesick.”
Later in 2004, Van Rooyan found Ed Bisch, a Philadelphia man who had begun a website to expose Oxy abuse in the wake of his teenage son’s death. The following year, Van Rooyan and her husband, a plastic surgeon, petitioned the Food and Drug Administration to require that OxyContin be made more abuse-resistant, and that its use be strictly limited to severe pain.
“This was an exhausting process, which she and Kirk did as a labor of love to try to save others,” Bisch recalled.
Van Rooyan became the California arm of a grassroots movement known as RAPP — Relatives Against Purdue Pharma. The group, originally just four in number, protested at physician meetings funded by pharmaceutical companies and testified before Congress. Van Rooyan enlisted the help of U.S. Sen. Dianne Feinstein (D-Calif.), who wrote the FDA on her behalf and later sent Van Rooyan a letter of commendation.
But most members of Congress did not reply to Van Rooyan’s letters, she said. The FDA said its review needed more time — which turned out to be eight years. By then, Purdue already had reformulated OxyContin to make it more abuse resistant and to renew its patent, but the FDA declined to restrict its use to managing severe pain.
Van Rooyan pressed on, but for a long while, the opioid crisis felt to her like a topic hiding in plain sight. And fighting Purdue while still grieving the loss of son Patrick was taking a toll.
“Her determination was tireless,” Bisch said, “but eventually the frustration burned us out.”
And then came the turn.
A rash of high-profile opioid overdoses and deaths, from actor Heath Ledger to Tom Petty to Prince, put the topic squarely in the public eye — and 15 years after the death of Van Rooyan’s son, Purdue Pharma and other drugmakers were suddenly on the run.
Van Rooyan tracks every development related to Purdue, including a lawsuit in New York that alleges members of the Sackler family have been offloading their fortunes into private or offshore accounts to shield them from a settlement.
But she’s not out for vengeance. Her goals have changed.
“Do I want the records to be public? Do I want these people to have their business shut down? Yes, I do,” she said. “But more than vindictiveness, I want that money of theirs to go to treatment and rehab. If that happens, something good can come out of it.”
If she has a regret, it is that the case in Virginia ended in 2007 with no more than a fine. “If that result had been different — if people had gone to jail — it could have changed the trajectory of this,” she said.
But momentum finally appears to be gathering, and Van Rooyan finds herself identified as one of the trailblazers of the anti-OxyContin movement. She spends little time dwelling on that. Instead, she quotes her younger son, Andrew, who told her, “We didn’t want any of this — this is just the hand we were dealt. We need to play the cards the best we can.”
“She’s just a really strong person,” said Kirk Van Rooyan, who has been with Barbara throughout the ordeal, though he is not Patrick’s biological father. “There have been times when I’d think to myself, ‘How would I be doing if I were in her shoes?’ And the answer usually is, ‘Not as well as she’s doing.’”
Van Rooyan, a longtime artist, now spends much of her time volunteering with veterans in Orange County, Calif., helping them get back into the workforce and using art therapy to help them express themselves.
The art is special to Van Rooyan, she said, because it is part of what saved her in the aftermath of her son’s death.
“Patrick was the one who suggested I take my first class,” she said. After a few delays, she finally enrolled. It was about a month before that Fourth of July in 2004.
While peanut allergies are the leading cause of death from food-induced allergic reactions in the country, a lack of approved preventive treatments has left families desperate for some kind of hope. The drug’s goal is not to cure the allergy, but to reduce the risk that an accidental exposure to small amounts of peanut.
The chemical, NDMA, has also been linked to dozens of recalls of prescription blood pressure drugs in the past year. No recalls have been started for the heartburn drug, but the FDA is recommending that people talk to their doctors and switch to different medications.
The bootleg medications were smuggled across the border and sold to mostly Latino immigrants in public spaces throughout Los Angeles — at swap meets, parks, beauty salons and makeshift stands outside mom-and-pop grocery stores.
The drugs were cheap, and the customers — mostly from Mexico and Central America — did not need prescriptions to buy them. Some of the products featured brand names and colorful packaging that immigrants knew well from their home countries — including Ciprofloxacina, a potent antibiotic, and Dolo Nervi Doce — translated as “Pain Nerve 12” — an injectable B-complex vitamin taken for fatigue.
Many were sheer counterfeits. Others, though legal south of the border, were not approved for sale in the United States. Some had expired. Still others would have been legal if sold by people licensed to do so — but none of the sellers held pharmacist licenses or any other medical credential.
L.A. County authorities seized the drugs last month in an operation that led to the arrest of eight people. Their haul included 100,000 foreign-made pills, compounds and injectable medicines they said could have caused serious harm or even death to consumers.
Immigrants, not just from Hispanic countries but from all over the world — and some non-immigrants too — are purchasing a wide array of illegal medications in black markets that are common not only in Southern California but in states such as Arizona, Maryland, Texas, Virginia and Washington, according to law enforcement officials and others familiar with the trade.
“We’re seeing this in all communities across the country that don’t have access to health care services,” said Adolph Falcon, executive vice president of the Washington, D.C.-based National Alliance for Hispanic Health, which provides information and health-related assistance to Hispanic communities nationwide. “These products prey on the desperation of people who can’t afford to see a doctor or go to a legitimate pharmacy.”
The current political climate in the U.S. is also pushing some immigrants to the black market, doctors and researchers say.
“Many patients are afraid they’ll be deported if they come into our clinics, so they buy from the street, said Dr. Anjali Mahoney, the Orange County, Calif., regional medical director for AltaMed Health Services, a large chain of federally funded community clinics whose patients are primarily Latino.
“People are paying for something that doesn’t work and could even harm them, when they could have just as easily come to a clinic and get safe care with a doctor,” Mahoney said.
She added that every one of AltaMed’s 23 clinics in Southern California has reported problems with off-the-street medications. One Latina woman was hospitalized after taking an opiate advertised as blood pressure medicine, she noted.
These dubious products targeted by law enforcement are different from the legitimate prescription pharmaceuticals imported for personal use every year by millions of U.S. residents who cross the border into Canada and Mexico or use licensed online pharmacies abroad to buy their medications at a fraction of the price they would pay in this country.
Although those imports are also technically illegal, guidelines from the Food and Drug Administration allow federal agents to take a hands-off approach.
That’s not the case with wares peddled on the streets by often unscrupulous operators.
“Counterfeit medicines may contain the wrong ingredients, contain too little, too much or no active ingredient at all — or contain other, potentially life-threatening hidden ingredients,” said Jeremy Kahn, an FDA spokesman.
Drug companies and pharmacies also have an interest in disrupting the distribution of such medications. The nationwide value of this pharmaceutical black market is difficult to gauge, but it may displace billions of dollars’ worth of legally approved medicine, said Roger Bate, an economist at the American Enterprise Institute and author of the book “Phake: The Deadly World of Falsified and Substandard Medicines.”
Between October 2017 and July 2018, FDA officials confiscated nearly 22,000 packages containing illegal pharmaceuticals from international mail facilities, Kahn said. He said authorities routinely impound various opioids as well as dietary supplements laced with erectile dysfunction drugs and other dubious products. They come from India, China and across Europe — “just about everywhere,” Kahn said.
The medications seized by the FDA are just the tip of the iceberg. The agency estimates it is able inspect fewer than 0.2% of the packages sent via international mail that are believed to contain drugs. And many illicit products arrive not through the mail but in suitcases, cars, trucks or cargo ships, authorities say.
The purveyors of these “dodgy medicines” are “myriad and global,” including Chinese and Indian manufacturers, Russian mobsters, Mexican gangs and domestic U.S. groups, said Bate. “There are charlatans and odious actors who don’t mind if their product kills children, adults or breadwinners of entire families.”
Nationwide, many local police departments lack the resources or mandate to investigate sales of illicit pharmaceuticals; otherwise, the number of arrests would probably be much higher, public and industry officials say.
“Not enough attention is paid to this issue,” said Jon Roth, CEO of the California Pharmacists Association. “It’s probably largely operating in the dark shadows of every community. If we put the resources there, we’d see how wide it is.”
L.A. County is one jurisdiction paying attention. In 1999, it formed the Health Authority Law Enforcement Task Force (HALT), after two Latino infants died from taking illegal medications. HALT is the group that made the August arrests.
So far this year, it has arrested 34 people in 54 cases, 48 of them involving illegal pharmaceuticals sold to immigrants, said Erick Aguilar, one of the investigators.
Illegal pharmaceuticals are being sold to immigrants in “every rural swap meet you can find,” and the sellers are becoming more sophisticated, Aguilar said. “They’re better at hiding it,” and “they’re more careful who they sell to.”
In February 2019, three men – two in Southern California and one from Salem, Ore. – pleaded guilty to the illegal importation and sale of $11 million worth of pharmaceutical-grade erectile dysfunction drugs falsely marketed across the U.S. as herbal remedies for men. One of the perpetrators imported from China powdered tadalafil, the active ingredient in Cialis, and used it to make 5.5 million pills with up to 14 times the level contained in Cialis, according to the FDA.
In 2017 and 2018, the Phoenix police department’s organized-crime commercial unit raided 30 pharmacies in Latino neighborhoods, confiscating “millions of dosages of illegal medicines, some of them outdated by 15 years,” said Detective Sgt. David Lake, who led the unit.
But not all the sellers were members of organized crime. Lake recalled one woman who genuinely believed she was doing something positive for her community by distributing black-market birth control pills.
“She said local girls were having too many babies, and she wanted to help them, but the babies kept being born,” Lake recalled. “When I told her the drugs were counterfeit, she cried for a half-hour straight.”
Drugmakers prefer to have their products go through the FDA approval process. “At the end of the day, [companies] control their products. It’s their property. You can pass a law saying people can try things, but unless you obligate companies to give something, there’s no right to gain access,” said Arthur Caplan, who heads the division of medical ethics at the NYU School of Medicine.
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The annual report from the Census Bureau, released this week, found that 27.5 million Americans were without health insurance last year, an increase of nearly 2 million from 2017. The 0.5 percentage point increase in the uninsured rate — to 8.5% — was the first in a decade and came as unemployment and other economic indicators have been good.
Meanwhile, the Trump administration signaled that it is moving to ban flavored vaping liquid used in e-cigarettes. Companies making the products have been accused of marketing to underage users with flavors like mango and bubble gum.
And Congress is back from its summer break, with legislation to address rising prescription drug prices and surprise medical bills still on the agenda.
This week’s panelists are Julie Rovner of Kaiser Health News, Joanne Kenen of Politico, Tami Luhby of CNN and Rebecca Adams of CQ Roll Call.
Among the takeaways from this week’s podcast:
- The Census Bureau’s report this week defied usual economic models. Normally, the more people employed, the more people insured.
- Health advocates blame a variety of actions by the Trump administration for the lower rate of insured Americans. Those include policies intended to deter people from staying on or signing up for Medicaid; the elimination of the tax penalty for not having coverage; and the announcement that immigrants’ use of public benefits such as Medicaid could affect their ability to get a green card allowing them to live and work in the U.S.
- The biggest surprise in the Census Bureau report was the increase in children without insurance. Coverage for kids has generally been a bipartisan goal on Capitol Hill. It’s not clear what caused that drop. It could just be a result of differences in how the survey was conducted, or it may be another sign of immigrants worried about whether using public insurance could lead to their deportation.
- The administration’s announcement that it is moving forward on a ban of flavored vaping products comes as worries grow among parents and public health officials about an epidemic of lung problems around the country. Among those worried parents is first lady Melania Trump.
- House Speaker Nancy Pelosi appears to be inching closer to releasing her plan to curb high drug prices. It’s not clear yet whether President Donald Trump will sign on to her effort. But Sen. Chuck Grassley (R-Iowa) is seeking support for his more modest plan instead, arguing to his Republican colleagues that if they don’t stand with him, they may be forced to accept Pelosi’s legislation if she manages to make a deal with the president.
- Opponents of some of the legislation to curb surprise medical bills appear to have made progress over Congress’ August recess with a major advertising campaign saying the measures would hurt local hospitals and doctors. Advocates say the legislation is not dead, but the strong momentum it had is waning.
Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read, too:
Julie Rovner: Vox.com’s “This life-threatening pregnancy complication is the next frontier in the abortion debate,” by Anna North
Joanne Kenen: The New York Times’ “Nursing Homes Are a Breeding Ground for a Fatal Fungus,” by Matt Richtel and Andrew Jacobs
Rebecca Adams: Kaiser Health News’ “‘UVA Has Ruined Us’: Health System Sues Thousands Of Patients, Seizing Paychecks And Claiming Homes,” by Jay Hancock and Elizabeth Lucas
Tami Luhby: The New York Times’ “Bernie Sanders Went to Canada, and a Dream of ‘Medicare for All’ Flourished,” by Sydney Ember
To hear all our podcasts, click here.
Members of Congress raked in almost $4 million from pharmaceutical manufacturers and their trade groups in the first six months of 2019. Two members — Sen. Chris Coons (D-Del.) and Sen. Thom Tillis (R-N.C.) — each received over $100,000. Rep. Greg Walden (R-Ore.) is $5,000 shy of qualifying for the “million-dollar club,” a group of current members who’ve received $1 million or more since 2007.
The pharmaceutical industry has a long history of seeking to influence legislation by donating to the committees controlled by powerful members of Congress. As they return from recess and drug-pricing legislation comes into focus, find out how much your state’s representatives and senators took from the industry by examining KHN’s exclusive “Pharma Cash to Congress” feature.
Since some people die with plenty of amyloid plaques and tangles and never develop dementia, research is expanding to explore the complex disease and how to care for patients. Other public health news is on sperm banks, HPV vaccines, CBD oils, longevity, neurology and more.
While a national effort is under way to lower opioid doses, many chronic pain patients feel unfairly treated and researchers say there’s been little research done on how to taper. Other news on the opioid epidemic covers pain education for doctors and helping the workforce in rural areas.
Drugmakers have come under intense fire following news of more deaths of patients rationing their insulin. Novo Nordisk is the latest company to try to address the high costs of their drug. The company will start a new cash discount program that will allow many American patients to buy a month’s supply for $99 starting next year.
Whether Congress will act this year to address the affordability of prescription drugs — a high priority among voters — remains uncertain. But states aren’t waiting.
So far this year, 33 states have enacted a record 51 laws to address drug prices, affordability and access. That tops the previous record of 45 laws enacted in 28 states set just last year, according to the National Academy for State Health Policy, a nonprofit advocacy group that develops model legislation and promotes such laws.
Among the new measures are those that authorize importing prescription drugs, screen for excessive price increases by drug companies and establish oversight boards to set the prices states will pay for drugs.
“Legislative activity in this area is escalating,” said Trish Riley, NASHP’s executive director. “This year, some states moved to launch programs that directly impact what they and consumers pay for high-cost drugs.”
And more laws could be coming before year’s end. Of the handful of states still in legislative session — including California, Massachusetts, Michigan, New Jersey, Ohio and Pennsylvania — debate continues on dozens of prescription drug bills. In New Jersey alone, some 20 proposed laws are under consideration.
“Both Democrat and Republican leaders have shown a willingness to pursue strong measures that help consumers but also protect state taxpayer dollars,” said Hemi Tewarson, director of the National Governors Association’s health programs.
Riley, Tewarson and others note, however, that states can go only so far in addressing rising drug prices, and that federal legislation would be necessary to have a major impact on the way the marketplace works.
Federal lawmakers are keeping a close eye on the state initiatives, Tewarson said, to gauge where legislative compromise may lie — even as Congress debates more than a dozen bills that target drug costs. Political divisiveness, a packed congressional schedule and a looming election year could stall momentum at the federal level.
The pharmaceutical industry has opposed most — though not all — state bills, said Priscilla VanderVeer, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, the industry’s main trade group.
“We agree that what consumers now pay for drugs out-of-pocket is a serious problem,” said VanderVeer. “Many states have passed bills that look good on paper but that we don’t believe will save consumers money.”
Limiting Gag Rules For Pharmacists
At least 16 states have enacted 20 laws governing the behavior of pharmacy benefit managers. The so-called PBMs serve as middlemen among drugmakers, insurance companies and pharmacies, largely with pharmaceutical industry support.
Those laws add to the 28 passed in 2018. Most of the new laws ban “gag clauses” that some PBMs impose on pharmacists. The clauses, written into pharmacy contracts, stop pharmacists from discussing with customers whether a drug’s cash price would be lower than its out-of-pocket cost under insurance.
With widespread public outrage over gag clauses pushing states to act, federal lawmakers got the message. In October, Congress passed a federal law banning such clauses in PBM-pharmacy contracts nationwide and under the Medicare Part D prescription drug benefit. The Senate passed it 98-2.
Even so, many of this year’s PBM laws contain additional gag clause limitations that go beyond the 2018 federal law.
Importing Cheaper Drugs
Four states — Colorado, Florida, Maine and Vermont — this year have enacted measures to establish programs to import cheaper prescription drugs from Canada and, in Florida’s case, potentially other countries. Six other states are considering such legislation.
Medicines in Canada and other countries are less expensive because those nations negotiate directly with drugmakers to set prices.
“This is an area where states once feared to tread,” said Jane Horvath, a consultant who has advised Maryland and Oregon, among other states, on prescription drug policy. “Now both Republicans and Democrats view it as a way to infuse more price competition into the marketplace.”
Hurdles remain, however. A 2003 law allows states to import cheaper drugs from Canada but only if the federal Health and Human Services Department approves a state’s plan and certifies its safety. Between 2004 and 2009, the federal government halted nascent drug import efforts in five states.
Even so, momentum for importation has built in recent years in states and Congress as drug prices have continued to rise. And the Trump administration this summer threw its support behind the idea.
Florida Gov. Ron DeSantis, a Republican and close ally of President Donald Trump’s, signed his state’s measure into law on June 11, claiming he did so after Trump personally promised him the White House would back the initiative.
On July 31, HHS announced an “action plan” to “lay the foundation for safe importation of certain prescription drugs.” The plan includes a process to authorize state initiatives. It also requires formal regulatory review, including establishing Food and Drug Administration safety criteria. That process could take up to two years.
Two big problems remain: In the weeks since the announcement, the Canadian government has opposed any plan that would rely solely on Canada as a source of imported drugs. The pharmaceutical industry also opposes the plan.
Creating Drug Affordability Boards
Maryland and Maine enacted laws this year that establish state agencies to review the costs of drugs and take action against those whose price increases exceed a certain threshold.
New Jersey and Massachusetts are debating similar legislation this year.
Maryland’s law establishes a five-member board to review the list prices and costs of drugs purchased by the state and Maryland’s county and local governments. The board will probe drugs that increase in price by $3,000 or more per year and new medicines that enter the market costing $30,000 or more per year or over the course of treatment.
If approved by future legislation, upper payment limits on drugs with excessive price increases or annual costs would take effect in January 2022.
“My constituents have signaled loud and clear that bringing drug prices down is one of their top priorities,” said state Sen. Katherine Klausmeier, a Democrat representing Baltimore, who sponsored the legislation.
Maine’s law also establishes a five-member board. Beginning in 2021, the board will set annual spending targets for drugs purchased by the state and local governments.
Increasing Price Transparency
This year, four states — Colorado, Oregon, Texas and Washington — became the latest to enact laws requiring drug companies to provide information to states and consumers on the list prices of drugs and planned price increases.
The majority of states now have such transparency laws, and most post the data on public websites. The details vary, but all states with such laws seek to identify drugs with price increases above 10% or more a year, and drugs with price increases above set dollar values.
Oregon’s new law, for example, requires manufacturers to notify the state 60 days in advance of any planned increase of 10% or more in the price of brand-name drugs, and any 25% or greater increase in the price of generic drugs.
“That 60-days’ notice was very important to us,” said Rep. Andrea Salinas, chair of the Oregon House’s health committee, who represents Lake Oswego. “It gives doctors and patients advance notice and a chance to adjust and consider what to do.”
The expensive new therapies can be life-changing, but working out how to pay for them has become a pain point for the health industry. “Employers are saying, ‘I just can’t afford it,’” said CVS Health Chief Medical Officer Troy Brennan. In other pharmaceutical news: drugmakers’ try to gain traction for next-generation sequencing but the going is slow; and Pfizer gets fast-track approval for a rare lung caner drug.
A new study finds that the plan–which would cap out-of-pocket spending for Medicare beneficiaries at $3,100–would help those who rack up astronomical bills while not significantly hurting those who have moderate ones.