The growing use of heroin and the abuse of prescription painkillers in Kentucky also mean that the state "is being ravaged by the diseases that follow in their wake: hepatitis and HIV. These dangers also reach far beyond addicts and their families, threatening a wide swath of the population," Laura Ungar reports for The Courier-Journal.
Kentucky has one-fourth of the 220 U.S. counties that the U.S. Centers for Disease Control and Prevention had judged to be at high risk for outbreaks of HIV and hepatitis C among intravenous drug users, Ungar notes in the second installment of a three-part series on heroin in Kentucky and adjoining states.
"Acute hepatitis B rose 114 percent in Kentucky, Tennessee and West Virginia from 2009 to 2013, even as incidence remained stable nationally, according to one study," she reports. "According to another study, the rate of new hepatitis C cases among people 30 and younger more than tripled from 2006 to 2012 in Kentucky, Tennessee, Virginia and West Virginia. More recently, cases of acute hepatitis B and C in Kentucky reached 281 last year, up from 120 in 2003."
Dr. Nora Volkow, director of the National Institute on Drug Abuse, told Ungar that hepatitis C has become the top cause of death from reportable infectious diseases in the U.S., and an HIV outbreak in Austin and Scott County, Indiana, �was a wake-up call� for the country. Ungar notes, "Addicts may also be spreading both diseases without knowing it. Up to three in four people with hepatitis C, and one in eight with HIV, don�t know they have it, experts say."
Dr. William Cooke, an Austin physician "who treats dozens of patients with HIV and hepatitis, said many communities are ill-equipped to handle the threat," Ungar writes. "All over the region and nation, he said, there�s too little substance abuse treatment, too little emphasis on the poverty that often accompanies addiction and too little compassion."
Kentucky has authorized needle exchanges where addicts can get clean syringes to avoid the threat of infection from contaminated needles. "Officials say needle exchanges are an important part of a comprehensive strategy to control disease," Ungar notes. "But critics argue these programs enable drug use, and many area residents reject the idea of using public money to fund them. So the prospect of more syringe exchanges in the region remains uncertain."
Ungar gives the basics of how the diseases spread: "HIV, which can be transmitted through semen and other bodily fluids in addition to blood, is mainly spread by having unprotected vaginal or anal sex with someone who has HIV, or sharing used needles, which can harbor live viruses for up to 42 days. But it also can be transmitted to health care workers by needle sticks, or from mother to child during pregnancy, birth or breastfeeding, especially if the mom isn't taking medicine.
"Hepatitis B and C, which are caused by separate viruses, are easier to catch than HIV because there are higher levels of virus in the blood. Hepatitis B is more often contracted through sex or accidental needle sticks than hepatitis C, but both types are commonly spread by sharing tainted needles."
"Accidental overdoses aren't the only deadly risk from using powerful prescription painkillers," The Associated Pressreports. "The drugs may also contribute to heart-related deaths and other fatalities, new research suggests."
A study of of more than 45,000 Medicaid patients in Tennessee from 1999 to 2012 found that "those using opioid painkillers had a 64 percent higher risk of dying within six months of starting treatment compared to patients taking other prescription pain medicine," AP reports. "Unintentional overdoses accounted for about 18 percent of the deaths among opioid users, versus 8 percent of the other patients."
"As bad as people think the problem of opioid use is, it's probably worse," said Vanderbilt University professor Wayne Ray, the lead author of the study report. "They should be a last resort and particular care should be exercised for patients who are at cardiovascular risk."
The report in the Journal of the American Medical Association noted that opioids can slow breathing and worsen the disrupted breathing associated with sleep apnea, which could lead to irregular heartbeats, heart attacks or sudden death.
The patients in the study "were prescribed drugs for chronic pain not caused by cancer but from other ailments including persistent backaches and arthritis," AP reports. "Half received long-acting opioids including controlled-release oxycodone, methadone and fentanyl skin patches. . . . There were 185 deaths among opioid users, versus 87 among other patients. The researchers calculated that for every 145 patients on an opioid drug, there was one excess death versus deaths among those on other painkillers. The two groups were similar in age, medical conditions, risks for heart problems and other characteristics that could have contributed to the outcomes."
The number of drug-overdose fatalities in Kentucky rose almost 15 percent in 2015, driven by a 247 percent jump in deaths involving fentanyl, a highly potent opioid that some traffickers are mixing with heroin, the Kentucky Office of Drug Control Policy said Tuesday.
The office counted 1,248 fatal overdoses in Kentucky last year, up 14.7 percent from the 1,088 reported in 2014. Fentanyl was a factor in more than a third: 420, up from 121.
"Heroin was detected in 28 percent of cases, consistent with the previous year," the Justice and Public Safety Cabinet said in a press release. "However, as a total, heroin-related deaths increased in 2015, largely because the drug is being laced with fentanyl."
�The introduction of illicit fentanyl into the heroin trade is producing devastating results,� Van Ingram, director of the office, said in the release. �Whether it�s manufactured to resemble heroin or a prescription pill, the cartels have made an already dangerous situation worse.�
Gov. Matt Bevin said, �I am heartbroken for the Commonwealth. More than three families a day are shattered by this epidemic of untimely death. This is unacceptable and will be vigorously addressed with every resource at our disposal.�
The report by Ingram's office listed the eight counties with the most fatal overdoses per person from 2012 to 2015. All were in Eastern Kentucky or Northern Kentucky. Here are the counties, with the number of deaths per 10,000 people: Leslie, 6.86; Bell, 6.12; Gallatin, 5.26; Knott, 4.87; Wolfe, 4.83; Floyd, 4.76; Campbell, 4.72 per 100,000 and Kenton, 4.63 per 10,000.
Counties with big percentage increases in fatal overdoses from 2014 to 2015 included Bell, from 11 to 20; Boyd, from 13 to 24; Butler, from none to eight; Harlan, from six to 10; Kenton, from 71 to 112; and Rowan, from five to 12.
Counties with large decreases included Bullitt, from 22 to 11; Grant, 13 to 6; Russell, from 13 to 7; Laurel, 18 to 10; Leslie, from nine to five; McCracken, 20 to 10; and Marshall, from 12 to fewer than five. The report does not list specific numbers for a county in years when the county had fewer than five fatal overdoses.
The figures above are based on where the death occurred. Based on the residence of the overdose victim, some counties ranked higher; for example, Powell County had 5.84 overdose deaths per 10,000 people, and Russell County had 4.95. This map shows rates based on the county where the overdose victims resided; note that it shows the death rate per 100,000 people, not 10,000 (a figure closer to the population of most counties). Click on the image for a larger version.
Kentucky is the only truly Appalachian state to have put a brake on fatal drug overdoses, report Rich Lord and Adam Smeltz of the Pittsburgh Post-Gazette as part of a series in the about the deadly epidemic of prescription painkillers in the region.
A chart with the series' story about Kentucky shows that fatal drug overdoses were less numerous in the state in 2013 than in 2012, when the General Assembly cracked down on "pill mills," and that while fatal overdoses rose in 2014, they were still not as numerous as in 2012. Official numbers for 2015 are expected soon, and may rise because of the spread of heroin.
The series also credited a crackdown by the Kentucky Board of Medical Licensure, which "took disciplinary action for prescribing irregularities against 135 of the state�s roughly 10,600 doctors" from 2011 to 2015. "The board also moved against 33 doctors during that time for abusing narcotics themselves."
"Getting tough on doctors works," Lord wrote in the series' main story. The state story reported, "Kentucky�s per-capita opioid consumption -- though still seventh in the nation -- dropped by a steepest-in-Appalachia 12.5 percent from 2012 to 2014, according to IMS Health Inc.," Lord and Smeltz report. "Kentucky is the only state, among the seven studied by the Pittsburgh Post-Gazette, in which fatal overdoses have plateaued. Elsewhere, they have climbed relentlessly."
The story quotes Kerry B. Harvey, U.S. attorney for the eastern half of Kentucky: �In much of Eastern Kentucky, the workforce is engaged in difficult, manual labor,� like mining, farming and logging, �so people would injure themselves and be prescribed these very potent narcotics, because the medical profession changed the way it looked at prescribing these kinds of narcotics for pain.� The drugs dulled the �sense of hopelessness� people had about the area�s economy, �and so for whatever reason, this sort of culture of addiction took hold.�
"Harvey said that as physicians have gone to jail, and others have faced board discipline, the painkiller business model has adapted. . . . Now the doctors take insurance, and bill the insurer or the government not just for the office visit, but for the MRI, urine screen and back brace they use to justify the addictive narcotic." Harvey said, �So instead of a cash business, in many cases now the taxpayers or the insurance companies pay. The result is the same. We end up with our communities flooded with these very potent prescription narcotics.�
CORBIN, Ky. � After a day of learning and talking about opioid prevention, treatment and mobilization, people at a forum in Corbin agreed on three things: Access to substance abuse and mental health services remains a huge barrier in southeastern Kentucky; more community education is needed; and drug-prevention programs should form coalitions to better use their limited resources.
Substance abuse affects almost every family in Kentucky, and four Kentuckians die every day from a drug overdose. That was part of the opening message from Dr. Allen Brenzel, medical director of the state Department for Behavioral Health, Development and Intellectual Disabilities. "This is, in my opinion, one of the most pressing health-care issues facing our commonwealth today," Brenzel said. "If 1,000 people a year were dying from measles in the state of Kentucky, think about the public response that we would have. ... We would be on red-alert, we would have a complete, public-health, massive intervention to solve that problem."
Van Ingram, executive director at the Governor's Office of Drug Control Policy, said that next year's drug overdose report, which will be released in a few weeks, will show the problem is getting worse.
About 125 people, most of them health-care providers, attended the "Cumberland River Forum on Opioid Use Disorders: A Time for Community Action" May 17 at the Corbin Technology Center. It was sponsored by The Kentucky Cabinet for Health and Family Services, the Hazelden Betty Ford Foundation, and Cumberland River Behavioral Health. Similar forums were held in Lexington May 16 and Louisville May 13.
John Tilley
John Tilley, secretary of the Kentucky Cabinet for Justice and Public Safety, said he hoped the forum would "light a fire under this community" to talk to their neighbors and friends, community leaders and legislators about the value of treatment over incarceration for substance abuse and mental health issues.
Tilley, who chaired the House Judiciary Committee when he was a state representative from Hopkinsville, acknowledged that some abusers should be in prison, but said society must distinguish between "who we are mad at and who we are afraid of. ... I promise you the way to get out of this mess is not to over-criminalize addiction and mental illness."
Tilley said "The solution is right before our eyes," using for treatment some of the billions of dollars now used to incarcerate drug users.
Tim Feeley, deputy secretary for the CHFS and a former legislator from Oldham County, agreed: "We are not going to incarcerate our way out of this." He said the state needs more treatment programs and said the cabinet was fully committed to addressing the state's addiction problems to the best of its abilities.
William Hacker
Kentucky has moved away from treating mental health and substance abuse issues criminally, said Dr. William Hacker, chair of Shaping Our Appalachian Region's Health and Wellness Advisory Committee and former state health commissioner. He said other successful anti-drug efforts include grassroots advocacy groups, the online prescription-drug tracking program, needle-exchange programs, a move toward medication assisted treatments for opioid addiction, and the SMARTS initiative, which provides addiction care for pregnant and parenting women for up to two years.
Hacker also mentioned Operation UNITE, a Kentucky non-profit created by U.S. Rep. Hal Rogers that leads education, treatment and law enforcement initiatives in 32 counties in Southern and Eastern Kentucky. UNITE has held a national drug abuse conferences for the past five years, with this year's summit in Atlanta including President Barack Obama. The acronym stands for Unlawful Narcotics Investigations, Treatment and Education.
A former pediatrician in Corbin, Hacker also noted that SOAR recently held a Substance Abuse Roundtable to discuss research and emerging opportunities associated with substance abuse and intravenous drug use in Appalachian Kentucky. He said SOAR works to create a network across the region to share best practices and money opportunities and to create community level empowerment.
"Substance abuse is not a failure of moral character, it is a disease," Hacker said. "Don't give up. Never give up."
At the end of the meeting, the attendees broke into groups that represented schools, community leaders, health-care professionals, parents and the faith community to discuss what actions they could take to address opioid abuse in their communities.
Most groups reported that lack of access to substance abuse and mental health treatment is a barrier in their communities. And while it was noted that some communities offer more services than others, several groups said they did not have enough counselors to support medication-assisted therapies or enough doctors willing to prescribe it. Lack of transportation was also mentioned as a barrier toward getting treatment in several groups.
Also, most groups said community members often aren't aware of the resources, so more community education is needed. They listed schools, churches and county Extension offices as possible sources of education, and noted that a community resource website would be helpful. They also said parents would benefit from a class to learn how to talk to their children about drugs.
The groups agreed that all sectors of the community were needed to combat substance abuse and suggested that drug prevention programs in each community should form coalitions to better use resources and information.
Oxycontin tablets (Los Angeles Times photo by Liz Baylen)
Why have so many people become addicted to the painkiller OxyContin? We know about the overselling of the drug by its manufacturer, Purdue Pharma, which cost the company $635 million in 2007 to settle an investigation by the Department of Justice. Now the Los Angeles Times reports on another big reason, which the settlement didn't address: In many people, OxyContin doesn't last as long as advertised, and "Patients can experience excruciating symptoms of withdrawal, including an intense craving for the drug," Harriet Ryan, Lisa Girion and Scott Glover report.
Purdue Pharma "launched OxyContin two decades ago with a bold marketing claim: One dose relieves pain for 12 hours, more than twice as long as generic medications," the writers report. "On the strength of that promise, OxyContin became America�s bestselling painkiller, and Purdue reaped $31 billion in revenue."
However, the Times reports, "Even before OxyContin went on the market, clinical trials showed many patients weren�t getting 12 hours of relief," as the company claimed. "Since the drug�s debut in 1996, the company has been confronted with additional evidence, including complaints from doctors, reports from its own sales reps and independent research. The company has held fast to the claim of 12-hour relief, in part to protect its revenue. OxyContin�s market dominance and its high price � up to hundreds of dollars per bottle � hinge on its 12-hour duration. Without that, it offers little advantage over less expensive painkillers."
In the late 1990s, when doctors began telling patients to take OxyContin at shorter intervals, "Purdue executives mobilized hundreds of sales reps to [refocus' physicians on 12-hour dosing. Anything shorter 'needs to be nipped in the bud. NOW!!' one manager wrote to her staff," the Times reports. "Purdue tells doctors to prescribe stronger doses, not more frequent ones, when patients complain that OxyContin doesn�t last 12 hours. That approach creates risks of its own. Research shows that the more potent the dose of an opioid such as OxyContin, the greater the possibility of overdose and death. More than half of long-term OxyContin users are on doses that public-health officials consider dangerously high, according to an analysis of nationwide prescription data conducted for The Times."
More than 7 million Americans have abused OxyContin in the last 20 years, according to the National Survey on Drug Use and Health, and a disproportionate number have been in Appalachia and Eastern Kentucky, where the drug has been called "hillbilly heroin." OxyContin "is widely blamed for setting off the nation�s prescription opioid epidemic, which has claimed more than 190,000 lives from overdoses involving OxyContin and other painkillers since 1999," the Times reports.
Purdue Pharma issued statement calling the Times story �long on anecdotes and short on facts� and said it was based on a �long-discredited theory.� Times spokeswoman Hillary Manning replied, �Our editors see nothing in Purdue�s statement that casts doubt on our reporting or our findings.� For details, click here.
With nearly one of three opioid prescriptions being abused, employers are not only subsidizing the cost of these drugs, they are also paying for the fallout that results from the abuse, according to a new study.
"The personal impact that opioid painkiller abuse takes on individuals, their friends, and family is absolutely tragic,� Kristin Torres Mowat, senior vice president of health plan and strategic data operations for Castlight Health, the health-information firm that led the study, said in a news release. �This crisis is also having a significant impact on the nation�s employers, both in the form of direct and indirect costs. From higher spending on healthcare, to lost productivity, to the dangers associated with employees abusing medications in the workplace: these are aspects of the crisis that are too often overlooked in the current discussion.�
The study, titled "The Opioid Crisis in America's Workforce," looked at anonymous claims data from nearly a million employer-based health insurance claims between 2011 and 2015, defining abuse as those who received more than a 90-day supply of opioid prescriptions and received prescriptions from four or more providers. It excluded claims that had cancer, palliative care or convalescence care diagnoses.
Graph from "The Opioid Crisis in America's Workforce" report
The study found that 22 of the top 25 cities that abuse opioids are in the rural South. Henderson was the only Kentucky town on this list, as part of the Evansville, Ind., metropolitan area, which had a 7.8 percent opioid abuse rate.
Kentucky ranks fourth in the nation for painkiller prescriptions, at about 130 prescriptions for every 100 people, Christine Vestal reports for Stateline. So why aren't more Kentucky towns on the list? "Anywhere with a ZIP code is included," Castlight spokeswoman Cynthia Cowen said in an email. "However, in less populated regions, showing the abuse rates may inadvertently lead to patient identification."
The Castlight study also found that on average, 4.5 percent of Americans who get narcotic painkiller prescriptions are abusers, and account for nearly one-third (32 percent) of total opioid prescriptions and 40 percent of opioid prescription spending.
And the cost to employers is huge, estimated at $10 billion annually for absenteeism and poor work productivity, says the report. In 2015, the study found that employers spent nearly twice as much ($19,450) in medical expenses on opioid abusers annually than on non-abusers ($10,853), a difference of $8,597.
The study offered some additional insights, including: baby boomers are nearly four times more likely to abuse opioids than Millennials; poorer people are twice as likely to abuse opioids as rich ones; states with medical marijuana laws have a lower opioid abuse rate than those that don't; patients with a behavioral health diagnosis of any kind are three times more likely to abuse opioids than those without one; and opioid abusers have twice as many pain-related conditions as non-abusers.
The federal Centers for Disease Control and Prevention has called this issue a public-health crisis and has asked doctors to change the way they prescribe opioids, by only prescribing them for three to seven days at the lowest possible effective dose.
According to the CDC, nearly 2 million Americans are abusing prescription opioids, resulting in 16,000 deaths per year. In 2014, the latest data available, 1,087 Kentuckians died of overdoses, according to the Kentucky Office of Drug Control Policy.
The report suggests that employers have a role to play in addressing this through the use of data and analytics to determine prescribing trends that can then help them better understand what their employers needs are as they relate to opioid use and abuse, and then to guide them to appropriate benefit programs to prevent or treat their addictions.
Nine years ago, three top executives of Purdue Pharma pleaded guilty to criminal charges of "misbranding" Oxycontin. The case appeared to be a landmark. In previous years, top executives of large health care corporations rarely faced legal consequences when their companies misbehaved. Yet in the Purdue Pharma/ Oxycontin case, things were not what they seemed. Maybe that is why this case never did yield a new era of accountability for top corporate health care leaders.
Background - the Oxycontin Guilty Pleas
In 2007, we posted about the executives' guilty pleas. Relying on the New York Times coverage, we noted that the Department of Justice charged that the company used aggressive, deceptive marketing, including claims that Oxycontin had little potential for addiction, even though they then knew otherwise. Unlike many other settlements, the executives and the company admitted their dishonesty, although they were not apparently charged with fraud.
In a statement, the company said: 'Nearly six years and longer ago, some employees made, or told other employees to make, certain statements about OxyContin to some health care professionals that were inconsistent with the F.D.A.-approved prescribing information for OxyContin and the express warnings it contained about risks associated with the medicine. The statements also violated written company policies requiring adherence to the prescribing information.'
'We accept responsibility for those past misstatements and regret that they were made,' the statement said.
While no executives went to jail, the three who pleaded guilty,
Michael Friedman, the company�s president, who agreed to pay $19 million in fines; Howard R. Udell, its top lawyer, who agreed to pay $8 million; and Dr. Paul D. Goldenheim, its former medical director, who agreed to pay $7.5 million.
appeared to be the top leaders of the company. So, at the time I concluded,
At least in the Purdue Pharma/ Oxycontin case top company leaders were prosecuted, pleaded guilty, and will personally have to pay substantial financial penalties. Maybe this will convince the leaders of health care organizations that deceptive marketing practices may not be in their long term interests. Up to now, it may have been too easy to be swayed by the enormous profits deceptive marketing can bring, and regard fines paid by the company as just a cost of doing business.
No Lasting Effects
I was much too optimistic. Alas, we have since documented numerous legal settlements, and other cases of at least alleged bribery, kickbacks, or fraud, in which the top organizational leaders who authorized or directed the questionable conduct never suffered any consequences for their actions. That is, they demonstrated impunity.
Meanwhile, Purdue Pharma has been in the news since 2007, and not in a good way. In particular, we noted that the company seemed to keep up manipulative, if not deceptive marketing efforts on behalf of its narcotic product. In 2010, Canadian medical students protested that their "education" about narcotics and pain management was influenced by Purdue marketing (look here). In 2012, we noted that a leading "key opinion leader" who had a key role promoting the liberalized, if not reckless use of narcotics to treat all sorts of chronic pain, and had financial relationships with numerous narcotic pharmaceutical manufacturers, including Purdue Phrama, later admitted that it was all "misinformation." Yet this aggressive promotion of narcotics was likely a major factor in the ongoing narcotic epidemic which has killed thousands in the US. And in January, 2016 we described how opposition to new CDC guidelines that suggested much more conservative use of narcotics seemed to be funded, if not orchestrated by narcotic pharmaceutical manufacturers, notably including Purdue Pharma. Finally, there have been many other stories about Purdue Pharma about which we failed to post.
One would think, however, that a company that admitted to a crime, and whose three top executives lost their jobs and also pleaded guilty to crimes, would at least change its ways, even if these guilty pleas and admissions did not inspire more attempts to hold top corporate health care leaders accountable.
An Assumption about Unaccountable Hired Mangers
But it turns out that some obvious assumptions that I and probably many other people made about the Purdue Pharma cases of 2007 were wrong. I implicitly assumed when I wrote my 2007 post that the three Purdue Pharma executives who pleaded guilty were the top leaders of the company.
Furthermore, as we have discussed elsewhere, the top executives of large, for-profit publicly held corporations, like most pharmaceutical companies, have become largely unaccountable. They may seem to exist in a bubble, in which they are hailed as visionaries, and paid exceedingly well no matter how their organizations perform. (Look here). However, many top hired corporate managers have mainly become "value extractors."
These executives are nominally accountable to their corporate boards of directors, which are supposed to represent the owners of the companies. However, most large pharmaceutical companies have numerous stockholders, who have no easy avenue to organize. Many of their stockholders, in turn, are mutual funds, retirement funds, etc whose shares in turn are owned by thousands more. These numerous, dispersed "owners" have little influence on corporate boards, who often functionally are dominated by cronies of the top management.
So when the three top Purdue executives pleaded guilty, at least it looked like in this case the unaccountable hired executives had been made accountable, if not to their boards of directors, at least to the courts.
But Who Owned Purdue?
But what you see is not always what you get. There was a hint buried in the NY Times article,
Between 1995 and 2001, OxyContin brought in $2.8 billion in revenue for Purdue Pharma, a closely held company based in Stamford, Conn. At one point, the drug accounted for 90 percent of the company�s sales.
As part of the plea agreement, Purdue Frederick, a holding company for Purdue Pharma that is also closely held, pleaded guilty to a felony charge of misbranding OxyContin.
The article did not further discuss the meaning and implications of the twice used phrase, "closely held." I confess I missed it entirely. However, it seems to have meant that rather than being a public corporation with numerous, dispersed stockholders, the owners of Purdue Pharma and its parent were a smaller group, perhaps a group who should have been accountable for the actions of their executives. However, the NY Times did not further describe this group. Neither did reports in other outlets, such as the Wall Street Journal, CBS, or Time. Nor did a variety of other news stories that mentioned Purdue Pharma through 2010.
The Oxycontin Billionaires
There were a fewother clues available in 2007, but would have not been easily found at that time. After the case's resolution was disclosed, an article appeared in the Corporate Crime Reporter (but was presumably only available at that time by subscription.)
Purdue is a privately held, very secretive company based in Stamford, Connecticut.
It�s controlled by the Arthur Sackler family. Arthur Sackler is the guy who, before he delivered OxyContin, brought to you the marketing for Librium and Valium. Walk on the mall in Washington and you walk by the Freer Gallery of Art and Arthur Sackler Gallery.
Art brought to you by Oxy.
New York Times correspondent Barry Meier is probably the most plugged in journalist on the topic. A couple of years ago, he wrote a book detailing the problem titled Pain Killer: A 'Wonder' Drug�s Trail of Addiction and Death (Rodale Books, 2004.)
So apparently Purdue Pharma and Purdue Frederick were privately held, the Sackler family held a controlling interest, and the Sackler family were rich enough to have their name attached to an art museum.
The relationship between the Sackler family and Purdue got no other attention I could find until 2010. In March of that year, another member of the family, Dr Mortimer D Sackler died, and his NY Times obituary led off with evidence of his wealth, and philanthropy,
Mortimer D. Sackler, a psychiatrist who was a co-owner of the pharmaceutical company Purdue Pharma, makers of the controversial painkiller OxyContin, and whose lavish gifts to the Guggenheim Museum, the Metropolitan Museum of Art and Columbia University made him one of New York City�s most prominent benefactors, died March 24 in Gstaad, Switzerland. He was 93 and had homes in London, Gstaad and Antibes, France.
The obituary also provided evidence of a direct relationship among the Sacklers, Purdue, and the development of Oxycontin.
The Sackler brothers were all doctors, and all businessmen as well. In 1952, while the three were working at the Creedmoor state psychiatric hospital, Arthur financed the purchase of a small drug manufacturer based in Greenwich Village, the Purdue Frederick Company, which Mortimer and Raymond Sackler ran as co-chairmen and which later became Purdue Pharma, now based in Stamford, Conn.
Then,
by the mid-1990s Purdue Pharma was still a small drug company. But with a new product, OxyContin, a powerful, long-acting, narcotic painkiller, the company hoped to join the ranks of industry giants. Indeed, by 2001 sales of the drug had reached nearly $3 billion and accounted for 80 percent of Purdue Pharma�s revenue.
The lavish scale of Sackler's generosity was indicated in The Sunday Times's "Rich List" for 2008, which noted that while he and his family owned a �500 million stake in the pharmaceutical business, Purdue Pharma, huge charitable contributions had cut their wealth to �300 million. Yet few knew much about the Sacklers apart from their association with the cultural institutions that bear their name.
However, I could find no echos of this story beyond these obituaries, and certainly none that prominently made their way into the health care world. In late 2011, about ten percent of a long piece by Fortune on Purdue made the Sackler's ownership and wealth clear, but did not discuss the implications.
The story only began to echo a little in 2014. That year, the prospect of a trial of a civil lawsuit against Purdue filed in the state of Kentucky, one of the most hard hit by the narcotic epidemic, promised to shake things up. A long Bloomberg story on the lawsuit was the first to suggest that the very wealthy Sackler family might bear some responsibility for how Purdue marketed Oxycontin, and the results on patients' and the public's health.
Kentucky lawyers plan another first for Purdue: They want to elicit testimony from the company�s board, which is dominated by members of the Sackler family, the wealthy philanthropists who own the company and have until now remained largely untouched by the controversy tied to the blockbuster drug that netted their business billions of dollars.
It underlined the tightness of the ties between the Sackler's and Purdue. The family does not merely own a controlling interest, but dominates the company's governance.
Purdue today is owned through holding companies and family trusts for the benefit of Mortimer and Raymond Sackler�s families, according to Raul Damas, a company spokesman. In all, nine members of the Sackler family are Purdue directors. In January, Raymond Sackler announced the appointment of Chief Executive Officer Mark Timney. None of the Sacklers has been named in the Kentucky suit.
Raymond, who remains on the board, and his children have been the most involved in the family business. His son, Richard, a physician, worked at Purdue for three decades before being named president in 1999. Now retired, he remains a director. A grandson, David Sackler, sits on the board and runs a family investment fund, Summer Road LLC, in New York. Raymond�s other son, Jonathan, is a director, too.
By the way, the Bloomberg article also detailed another point (which had been mentioned in the obituaries and the CNN article). One member of the Sackler family was behind the aggressive, deceptive marketing campaign that sparked so many sales of Oxycontin. In fact, this Sackler brother could be viewed as the father of modern aggressive, deceptive pharmaceutical/ biotechnology/ device corporate marketing.
Raymond and Mortimer ran the company together. Arthur, the oldest, appears to have been primarily an investor and adviser.
Considered the father of modern pharmaceutical marketing, Arthur Sackler created the first medical-journal advertising insert to promote a drug and pushed for hiring sales reps long before they became as common in physicians� waiting rooms as out-of-date magazines. Purdue used many of Arthur Sackler�s tactics when it introduced OxyContin, a time-released dose of the opioid oxycodone, in 1995.
CNN had gone into a bit more detail on Arthur Sackler's previous work:
Arthur, joined a small advertising agency that specialized in marketing pharmaceuticals. (He also funded his brothers� purchase of Purdue, according to a 2003 book by New York Times reporter Barry Meier called Pain Killer: A Wonder Drug�s Trail of Addiction and Death.) Arthur was so successful that in 1997 he was one of the first people named to the Medical Advertising Hall of Fame, whose website credits him with helping 'shape pharmaceutical promotion as we know it today.' As early as the 1950s he was experimenting with TV marketing, and according to the entry, Arthur�s scientific knowledge and ability to expand the uses for Valium helped turn it into the first $100 million drug ever. Arthur�s philosophy was to sell drugs by lavishing doctors with fancy junkets, expensive dinners, and lucrative speaking fees, an approach so effective that the entire industry adopted it.
So at least this article credits Dr Arthur Sackler, of Purdue Pharma, with being one of the creators of the web of conflicts of interest that has ensnared many medical professionals in the last decades. Who knew?
Just to ice this cake, in later 2015, it became apparent that the Sacklers did not merely become wealthy from Purdue profits and Oxycontin sales. They became fabulously wealthy. Forbes listed the Sackler family that year as one of the 20 richest US families, estimating their combined wealth as $14 billion.
The Sackler family, which owns Stamford, Conn.-based Purdue Pharma, flew under the radar when Forbes launched its initial list of wealthiest families in July 2014, but this year they crack the top-20, edging out storied families like the Busches, Mellons and Rockefellers.
How did the Sacklers build the 16th-largest fortune in the country? The short answer: making the most popular and controversial opioid of the 21st century � OxyContin.
Purdue, 100% owned by the Sacklers, has generated estimated sales of more than $35 billion since releasing its time-released, supposedly addiction-proof version of the painkiller oxycodone back in 1995.Its annual revenues are about $3 billion, still mostly from OxyContin. The Sacklers also own separate drug companies that sell to Asia, Latin America, Canada and Europe, together generating similar total sales as Purdue�s operation in the United States.
Forbes estimates that the combined value of the drug operations, as well as accumulated dividends over the years, puts the Sackler family�s net worth at a conservative $14 billion.
Perhaps if the Kentucky lawsuit had gone to trial, these echos would have gotten even louder.
However, in December, 2015, Purdue settled the suit for $24 million, admitting no liability, and keeping the Sackler name out of the limited press coverage (although see this in STAT by Ed Silverman.)
I, for one, only found out about the Sackler / Purdue linkage when STAT published a followup in March, 2015. It turns out that in the run up to the Kentucky trial, a member of the Sackler family was actually deposed. This may have been the only direct discussion of the Oxycontin case by a member of the family.
The settlement required the attorney general to 'completely destroy' or return to Purdue all documents it received from the company or from any other party through a subpoena. The attorney general was given 60 days from the Dec. 18 agreement to comply. The agreement also prohibits the attorney general from sharing the documents with any other entity investigating or litigating against Purdue.
The attorney general�s office destroyed millions of pages of documents within the 60-day period, according to spokesman Terry Sebastian.
While the attorney general destroyed the records in its possession, copies of some of those records remain under seal in the Pike County courthouse, including the Sackler deposition.
The STAT article noted that millions of pages of records from other Oxycontin litigation were destroyed or returned to the company as stipulated by previous settlements. This time,
STAT is making a motion to intervene in the settled Kentucky lawsuit. The motion was sent to the Pike Circuit Court Monday via overnight courier.
The motion argues that STAT and the public have a constitutional right to the records that trumps Purdue�s interest in keeping them secret. The motion also states there is a substantial public interest in the case, citing the epidemic of drug addiction and related crime stemming from the abuse of OxyContin in Kentucky and other states. STAT is requesting the court make the documents available immediately.
We will see how this attempt to shine a little light on the long running Oxycontin story goes. I am not optimistic, since this long-running case has vividly shown how those who have the biggest vested interests in keeping our commercialized, overutilizing, over-marketed health care system going can use money and influence to keep it all so anechoic.
Summary
So now we see, dimly, reasons why the penalties handed out to "top" Purdue Pharma executives for the deceptive "misbranding" of a dangerous narcotic failed to end the impunity of top health care leaders. Those supposed "top men" were not really the top.
Just like in "Raiders of the Lost Ark,"
They were hired managers with fancy titles who worked for a secretive family which owned Purdue Pharma, which was apparently directly involved in the engineering of the aggressive, deceptive, "misbranding" sales campaign which sold so much Oxycontin, which became fabulously wealthy from the ownership of the company, and which managed to conceal their relationship to the company from nearly all prying eyes. So far, the family seems to either have befuddled or intimidated law enforcement sufficiently to prevent any direct consequences from befalling them.
This case vividly demonstrates, first, how those who have personally gained the most from our current dysfunctional health care system have often brilliantly covered up what they were doing (part of what we have called the anechoic effect). As long as we do not know where the money goes, and how it is made, we do not know what needs to be done to make things better. True health care reform requires bright sunlight to be shown on how the health care sausage is made, who makes it, and how they profit from it. As long as we the people let ourselves stay in the dark, we will continue to endure our woefully overpriced, inaccessible, mediocre quality, and all too often frankly corrupt health care system.
A piece this long and heavy deserves a musical interlude. Here is a live performance by the Dramatics of "What You See Is What You Get," (if only that were the case here).
Doctors who prescribe highly addictive painkillers for chronic pain should stop and be much more careful to thwart "an epidemic of prescription opioid overdoses" that is "doctor-driven," the federal Centers for Disease Control and Prevention said Tuesday, March 15.
"This epidemic is devastating American lives, families, and communities," the CDC said. "The amount of opioids prescribed and sold in the U.S. quadrupled since 1999, but the overall amount of pain reported by Americans hasn�t changed."
Kentucky ranks very high in use of opioids and overdoses from them, and Louisville reported a big increase in overdoses this month, Insider Louisvillereports.
The agency said doctors should limit the length of opioid prescriptions to three to seven days, use "the lowest possible effective dosage," monitor patients closely, and clearly tell them the risks of addiction.
It said most long-term use of opioids should be limited to cancer, palliative and end-of-life treatment, and that most chronic pain could be treated with non-prescription medications, physical therapy, exercise and/or cognitive behavioral therapy.
The guidelines are not binding on doctors, but Dr. Thomas Frieden, the CDC director, "said state agencies, private insurers and other groups might look to the recommendations in setting their own rules," the Los Angeles Timesreported.
However, Modern Healthcare reported that the guidelines are unlikely to change physicians' practices. "One current hurdle to curbing the number of prescriptions is that it's much easier for a busy clinician to prescribe a 30-day supply of oxycodone or Percocet to treat a patient's chronic pain than it is to convince him or her to do physical therapy," Steven Ross Johnson writes. "The time constraints affecting physicians' practice has never been more acutely felt than in this era of health-care reform that emphasizes quality and value-based payment."
Money could be a key in making the guidelines effective. Sabrina Tavernise of The New York Timeswrites, "Some observers said doctors, fearing lawsuits, would reflexively follow them, and insurance companies could begin to us them to determine reimbursement." The federal Centers for Medicare and Medicaid Services could also play a role.
Johnson notes that physicians are trained to "reserve opioids for severe forms of pain . . . but in the 1990s, some specialists argued that doctors were under-treating common forms of pain that could benefit from opioids, such as backaches and joint pain. The message was amplified by multi-million-dollar promotional campaigns for new, long-acting drugs like OxyContin, which was promoted as less addictive." Purdue Pharma, maker of OxyContin, agreed to pay $600 million in penalties to settle federal charges that it over-promoted the drug to doctors, prompting the epidemic, especially in Central Appalachia.
"When reports of painkiller abuse surfaced, many in the medical field blamed recreational abusers. In recent years, however, the focus has shifted to the role of doctors," Harriet Ryan and Soumya Karlamangla report for the Times, noting that a 2012 analysis "of 3,733 fatalities found that drugs prescribed by physicians to patients caused or contributed to nearly half the deaths."
Doctors, insurers, drug companies and government agencies "all share some of the blame, and they all must be part of a solution that will probably cost everyone money," Caitlin Owens writes for Morning Consult, which also notes prescribers' complaints and CDC's responses.
As I have written before as a physician who saw too many dire results of intravenous drug abuse, I was amazed how narcotics were pushed as the treatment of choice for chronic pain in the 1990s, with the result that the US was once again engulfed in an epidemic of narcotic abuse and its effects. In mid-December, 2015, as reported in the Washington Post,
The nation continues to suffer through a widespread epidemic to prescription opioids and their illegal cousin, heroin. The CDC estimated that 20 percent of patients who complain about acute or chronic pain that is not from cancer are prescribed opioids. Health-care providers wrote 259 million prescriptions for the medications in 2012, 'enough for every adult in the United States to have a bottle of pills,' the CDC wrote.
Last week, the National Center for Health Statistics reported that the number of overdose deaths from legal opioid drugs surged by 16.3 percent in 2014, to 18,893, while overdose fatalities from heroin climbed by 28 percent, to 10,574. Authorities have said that previous efforts to restrict prescription drug abuse have forced some people with addictions to the medications onto heroin, which is cheaper and widely available.
This rising tide of death and morbidity seems to have been fueled by reckless, sometimes deceptive, sometimes illegal marketing by the pharmaceutical companies that produced narcotics other than heroin.
Background - Legal Drug Pushing
As I wrote in 2013,
the realization began to dawn that patients, doctors and society were being victimized by a new type of pusher man, this time dressed in a suit and working for an 'ethical' drug company. In the earlier days of Health Care Renewal, we first posted (in 2006) about allegations of deceptive and unethical promotion of fentanyl by Cephalon that lead to its overuse by patients beyond those with cancer who were its ostensible target population. Then in 2007 came the spectacular case of guilty pleas by a subsidiary of Purdue Pharma and several of its executives for 'misbranding' Oxycontin, that is, promoting it far beyond any medically legitimate use in severe chronic pain. Following that various investigations, well chronicled in the Milwaukee Journal Sentinel, showed how pharmaceutical companies employed deceptive marketing techniques, subverting medical education and research, and creating conflicted key opinion leaders and institutionally conflicted disease advocacy groups, to push more 'legal' narcotics For example, see the Journal Sentinel reports the subversion of : medical schools and their faculty; .medical societies, disease advocacy groups, and foundations; and guideline writing panels. In 2012, we posted about how a drug company paid key opinion leader admitted to second thoughts about his role promoting narcotics.
As I described in that 2012 post, the new narcotic pushers relied on only the most sketchy evidence about the safety of prescription narcotics. In the 1990s, they taught that the rate of addiction caused by prescribing legal narcotics was only 1%, but this was based on a tiny flawed case series of a mere 38 patients. In 1996, a consensus statement from the American Academy of Pain Medicine and the American Pain Society, entitled "The Use of Opioids for the Treatment of Chronic Pain," included the following statements,
Pain is often managed inadequately, despite the ready availability of safe and effective treatments.
Studies indicate that the de novo development of addiction when opioids are used for the relief of pain is low.
Yet one of the primary proponents of profligate use of narcotics to treat chronic pain later admitted he
erred by overstating the drugs' benefits and glossing over risks. 'Did I teach about pain management, specifically about opioid therapy, in a way that reflects misinformation? Well, against the standards of 2012, I guess I did,' Dr. Portenoy said in an interview with The Wall Street Journal. 'We didn't know then what we know now.'
Also,
'I gave innumerable lectures in the late 1980s and '90s about addiction that weren't true,' Dr. Portenoy said in a 2010 videotaped interview with a fellow doctor. The Journal reviewed the conversation, much of which is previously unpublished.
In it, Dr. Portenoy said it was 'quite scary' to think how the growth in opioid prescribing driven by people like him had contributed to soaring rates of addiction and overdose deaths. 'Clearly, if I had an inkling of what I know now then, I wouldn't have spoken in the way that I spoke. It was clearly the wrong thing to do,' Dr. Portenoy said in the recording.
The CDC Attempts to Moderate the Use of Opioids for Chronic Pain
So to me it seems quite reasonable the US Center for Disease Control and Prevention (CDC), being cognizant of the rising toll of narcotic addiction, would attempt to do something about it. As reported by the Washington Post,
The government on Monday urged primary-care physicians who prescribe opioids for pain relief to rein in their use of the drugs, proposing new guidelines that call for a more conservative approach than the one that has led to a crippling epidemic of addiction to the powerful narcotics.
Just a few days after a new report showed a surge of drug-related overdoses in 2014, the Centers for Disease Control and Prevention suggested in draft recommendations that physicians tackle chronic pain with other methods, such as physical therapy and non-opioid analgesics, before turning to the powerful medications. If opioids, such as OxyContin and Percocet, are necessary, the agency recommended short-acting versions over extended release formulations, the lowest possible dose and short-term prescriptions.
It also suggested that doctors ask patients to take urine tests before prescribing opioids and additional urine tests at least once a year if they continue on the drugs, to ensure that they aren't secretly taking other opioids or illegal drugs.
'What we want to just make sure is that doctors understand that starting a patient on an opiate is a momentous decision,' said CDC director Tom Frieden. 'The risks are addiction and death, and the benefits are unproven.'
Based on the events since they 1990s, the lack of clear data from well performed randomized controlled trials of the effectiveness of opioids in chronic pain, and their obvious, known risks, that seems like common sense to me.
The Strong but Obscure Opposition to the CDC Guidelines
However,others disagreed. The guidelines attracted immediate opposition, for reasons that were not immediately obvious. Four days after the Post article, the Associated Press reported that the guidelines were in big trouble,
A bold federal effort to curb prescribing of painkillers may be faltering amid stiff resistance from drugmakers, industry-funded groups and, now, even other public health officials.
Also,
Critics complained the CDC guidelines went too far and had mostly been written behind closed doors. One group threatened to sue. Then earlier this month, officials from the FDA and other health agencies at a meeting of pain experts bashed the guidelines as 'shortsighted,' relying on 'low-quality evidence.' They said they planned to file a formal complaint.
The CDC a week later abandoned its January target date, instead opening the guidelines to public comment for 30 days and additional changes.
Anti-addiction activists worry the delay could scuttle the guidelines entirely.
This, however, did not make much sense. I repeat, the evidence that narcotics are effective for chronic pain other than that due to terminal cancer is very weak. The evidence that opioids have multiple side effects, some fatal, and can cause addiction, which has more side effects, and bad societal consequences, is strong. So the evidence that narcotics have benefits that are worth their harms, both to individuals and society, in this setting is essentially non-existent. So why did these guidelines go too far? Why invoke low quality evidence, when the evidence that is low quality is about the benefits of the drugs? Who should be sued? Furthermore, why did the CDC cave in so readily to these critics?
The AP noted,
But industry-funded groups like the U.S. Pain Foundation and the American Academy of Pain Management warn that the CDC guidelines could block patient access to medications if adopted by state health systems, insurers and hospitals.
Of course they could reduce access. The whole point of the guidelines is to reduce access. But who would want more access to medicines that do more harm than good?
Then there was the issue of just who it was who opposed the guidelines. Much of the opposition seemed to come from rather obscure organizations with authoritative names. Some of the opposition was chronicled by equally obscure, apparently journalistic organizations. (From now on, I will highlight these mysterious organizations by using bold, italic text in this color.) For example, according to the Washington Post,
Many of the patient and physician groups opposing the CDC guidelines are part of a larger coalition called the Pain Care Forum, which meets monthly in Washington to strategize on pain issues. Officials from the White House, the FDA, NIH and other agencies have met with the group over the years, according to documents obtained by The Associated Press under the Freedom of Information Act.
The Pain Care Forumpresents itself as a leaderless collective that does not take formal positions. But most members receive funding from drugmakers, including OxyContin-maker Purdue, whose chief lobbyist helped found the group and remains at its center.
The mission of the Pain Care Forum, its organizational nature (informal group, membership society, non-profit advocacy group, etc), its leadership, and its sources of funding were not entirely obvious from this article. But certainly the drift of the article was that the organization maybe represents pharmaceutical manufacturers, particularly the previously discredited Purdue Pharma (see above) more than others. So why not take what it says with many grains of salt.
But who threatened to sue? Which FDA officials chimed in, and why, given that the FDA does not have a mission that includes writing guidelines? That was not clear from the AP story.
My attempts to gain further clarity produced more mystification. A Medscape article also claimed that the opposition to the CDC guidelines included Dr James Madara, the Executive Vice-President and CEO of the American Medical Association, and "some members of the Interagency Pain Research Coordinating Committee [who] criticized the process, according to the Pain News Network." It was not clear whether Dr Madara's viewpoint had broad support in the AMA, which members of the Interagency Pain Research Coordinating Committee opposed the CDC guidelines, and whether this opposition was personal, or reflected the considered viewpoint of the committee. Furthermore, that committee's purview does not obviously include clinical guideline development or public health, so why it was commenting on this issue was also unclear.
The Pain News Network story which apparently was the source used by the Medscape in turn referred to a Politico story, but one which is only available to subscribers. The Pain News Network also credited a survey by "the Pain News Network and the Power of Pain Foundation."
The Medscape article said nothing more about the Pain News Network.which is not exactly a household word in health care journalism. The Pain News Network story did not give more detail about the Power of Pain Foundation, whose mission, nature, leadership, funding etc was not obvious.
The Pain News Network story also quoted the Washington Legal Foundation's chief counsel.
The overly secretive manner in which CDC has been developing the Guideline serves the interests of neither the healthcare community nor consumers.
Similarly, the Washington Post article also credited the Washington Legal Foundation's opposition to the CDC guidelines,
The Washington Legal Foundation, a public interest law firm dedicated to protecting the free enterprise system, accused the CDC of trying to formulate them secretly by failing to make public the work of its original advisory committee, the Core Expert Group. The CDC disputes that accusation, but issued the recommendations in draft form Monday and will have them reviewed by another advisory panel after receiving more comment over the next 30 days, Frieden said.
Yet, neither the Pain News Network nor the Post explained why a group supporting "free enterprise" was so concerned about this issue, or what expertise it might have in this area. It is ironic that a group that proclaims opposition to secrecy seems less than transparent about its involvement in this issue.
Finally, the nature of the Pain News Network, which claims to be a "non-profit, independent news source," is also obscure. It appears to be one of those non-profits that has no physical address per its web page of contact information, does not disclose its sources of funding, and if it files US Internal Revenue Service 990 forms, I cannot find them.
The most detailed article I could find about the substance of the complaints about the CDC guidelines was in another obscure source, the Legal News Line. The article mostly described the concerns of
Peter Pitts, a former associate commissioner of external affairs at the U.S. Food and Drug Administration and now president and co-founder of theCenter for Medicine in the Public Interest, can be counted among those critical of how the panel was put together.
Pitts' main issue was that a member of the group that developed the CDC guidelines was biased. He said,
'So you have to have as open of a mind as possible.'
And that�s exactly where the CDC went wrong, Pitts said, pointing to Jane Ballantyne. Ballantyne served as a member of the CDC�s �Core Expert Group,� which played a key role in developing the agency�s opioid guidelines.
Ballantyne, a retired professor of anesthesiology and pain medicine at the University of Washington, is a member of the International Association for the Study of Pain, or IASP, and last year was named president of the Physicians for Responsible Opioid Prescribing, or PROP.
PROP�s mission, according to its website, is to 'reduce opioid-related morbidity and mortality by promoting cautious and responsible prescribing practices.'
'Not only does she have strong opinions, but extra strong opinions -- almost on the lunatic fringe -- on pain medicine issues,' Pitts said.
'For the CDC to say, we�re going to put someone who comes to the discussion with such preconceived notions on such a committee, you have to ask yourself, why? And then why was it hidden from the public?'
The Legal New Line's example of supposed journalism did not apparently ask Pitts what was "lunatic" about wanting to promote cautious and responsible prescribing of opioids. That seems to me like common clinical sense, the opposite of insanity.
Also, Pitts complained that beyond this alleged bias, Dr Ballantyne had a conflict of interest,
Pitts noted Ballantyne�s connection to law firm Cohen Milstein Sellers & Toll PLLC -- a plaintiffs law firm that is known for its class action lawsuits and has been hired by a number of state attorneys general in recent years, including some of those to whom it donated.
Ballantyne reportedly disclosed her services as a paid consultant for Cohen Milstein to the CDC. The firm currently is helping to represent the City of Chicago in a lawsuit filed against a group of pharmaceutical companies over the marketing of opioid painkillers.
Note that in the first paragraph above, the writer apparently meant that the law firm donated to the campaigns of the attorney generals.
More importantly, why the apparent conflict of interest affecting a single member of a large group - the core expert group of which Dr Ballantyne sat included 17 people - was so important was not apparent from Mr Pitts' argument. Mr Pitts did not explain how any sort of advisory group that included experts in the field could avoid people who already had strong opinions about that field. The Legal News Line article did not discuss Mr Pitts' own background, or provide any information about the Center for Medicine in the Public Interest, which he leads.
I could not find reporting in major news outlets or medical/ health care scholarly publications about the opposition to the CDC guidelines beyond the stories in the Washington Post, AP, and Medscape, and a brief report in Modern Healthcare. I did find numerous articles on yet another little known website called the National Pain Report, (e.g. see this one).
So to summarize so far, the opposition to the new CDC opioid guidelines was apparently strong enough to delay, if not derail them. Yet who was in the opposition, their funding, and their interests remains obscure. The arguments of the opposition remain unclear. Even some of the purported journalists reporting on the opposition remain mysterious. There seems to be a tremendous amount of fog surrounding the opposition to more conservative prescribing of narcotics for non-cancerous chronic pain.
It was striking that much of the opposition seemed to come from rather mysterious organizations, the Pain Care Forum, Power of Pain Foundation, Washington Legal Foundation, and Center for Medicine in the Public Interest. However, the reporting on these organizations was minimal. Furthermore, some of the news sources reporting on the opposition to the CDC guidelines also were rather mysterious, such as the Pain News Network, National Pain Report, and Legal News Line.
One recent media article, and some of our previous blogging, though suggest that the opposition organizations all have ties to the pharmaceutical industry, and in several cases, directly to one of the major producers of legal opioids. On December 23, 2015, Lee Fang wrote in the Intercept by way of an introduction,
The pharmaceutical companies that manufacture and market OxyContin, Vicodin, and other highly addictive opioid painkillers � drugs that have fueled the epidemic of overdoses and heroin addiction � are funding nonprofit groups fighting furiously against efforts to reform how these drugs are prescribed.
In particular,
An investigation by The Intercept has found that the pharmaceutical companies that dominate the $9 billion a year opioid painkiller market have funded organizations attacking reform of the prescribing guidelines:
The Washington Legal Foundation, a nonprofit that litigates to defend 'free-market principles,' threatened the CDC with legal action if the agency moved forward with the proposed opioid guidelines. The WLG claimed the CDC�s advisory panel for the guidelines lacked 'fair ideological balance,' because it included a doctor who is part of an advocacy effort against opioid addiction. The WLF does not disclose donor information, but has filed friend-of-the-court briefs on behalf of Purdue Pharma, the makers of OxyContin. In a recent article with Pain News Network, a spokesperson for Purdue Pharma conceded: 'We�re long-standing supporters of WLF, in addition to several other business and legal organizations. We�ve provided them with unrestricted grants.'
The Pain Care Forum organized opposition to the CDC prescribing guidelines, mobilizing regular meetings among stakeholders opposed to the idea, according to an investigation by AP reporter Matthew Perrone. A recently re-filed complaint by the City of Chicago found that Burt Rosen, the chief in-house lobbyist for Purdue Pharma, controls the Pain Care Forum. A former drug company employee allegedly told investigators that Rosen tells the Pain Care Forum 'what to do and how we do it.' The Pain Care Forum is funded through contributions by Purdue Pharma, as well as major opioid manufacturers Cephalon, Endo, and Janssen, a subsidiary of Johnson & Johnson.
The Power of Pain Foundation, a groupfunded by Purdue Pharma, asked supporters to contact the CDC in opposition to the guidelines, claiming that 'taking away pain medication and making providers afraid to prescribe due to your guidelines is only going to make more abusers, increase suicides, and tear apart the lives of millions.'
Fang also noted that the Legal News Line, the source of the story documenting Peter Pitts' problems with the CDC guidelines, also is tied to the pharmaceutical industry:
The U.S. Chamber of Commerce, a corporate lobbying group that represents opioid manufacturers, including Johnson & Johnson, issued a press release masquerading as a news story [published by the Legal News Line] criticizing the CDC guidelines. (The U.S. Chamber operates a public relations effort dressed up as a bona fide media outlet called Legal Newsline, which it uses to disseminate stories that support the political priorities of its member companies.)
In addition, on Health Care Renewal we have previously discussed the Center for Medicine in the Public Interest. Back in 2008, we noted that when writing for the New York Times, Mr Pitts had to disclose that the Center for Medicine in the Public Interest receives pharmaceutical industry funding, including from Pfizer and the PhRMA. At that time, Mr Pitts' day job was Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvege and Lee had many big pharmaceutical accounts Since then, he moved on to become director for global healthcare at Porter Novelli, also a public relations/ communications company with many health care corporate clients, including pharmaceutical companies, and now appears to be a consultant in the life sciences area for YourEncore. I cannot find any updated information on current Center for Medicine in the Public Interestfunding, but there is no reason to think that it is not still funded by the pharmaceutical industry.
Mr Pitts' published objections to the CDC guidelines had to do with the supposed bias and conflicts of interests of a single member of the guideline expert panel, and the alleged lack of transparency of the guideline project. Yet Mr Pitts was not very transparent about his own background, and his and his organizations' financial interests. For Mr Pitts to condemn the guideline panel member's conflict while hiding his own conflict amounts to a garish example of the logical fallacy of special pleading. Similarly, the Washington Legal Foundation's objections to the alleged biases of the guideline panel, given that foundation is apparently funded by Purdue Pharma, is another garish example of the same logical fallacy.
On the other hand, the Pain News Network and the National Pain Report remain obscure. The former claims to be a non-profit organization, but I cannot find its federal 990 filing, identify its board of trustees, or even determine its physical address. It does claim an affiliation with the Power of Pain Foundation. The National Pain Report at least has a physical address, which it shares with the equally obscure American News Report. Other details, like its ownership, remain obscure. The failure of supposedly journalistic organizations to publicly reveal basic information about their nature and operations does raise suspicions that they are not really so journalistic.
Summary
In summary, the organizations most widely mentioned as opposing the new CDC guidelines that recommend more conservative use of opioids for chronic pain seem to be heavily involved with the pharmaceutical companies that make such opioids. Thus, the opposition to the guidelines seems to be arising from a stealth public relations campaign leading to stealth health policy advocacy. Furthermore, at least so far, the objections to the guidelines do not seem clearly based on logic and good evidence from clinical research, again suggesting they are more about financial interests than improving patient outcomes and reducing risks.
Overuse and misuse of opioids, which may lead to all the individual and social consequences of opioid addiction, are clearly major, worsening medical and public health issues. We need earnest effort to address these problems, which should be informed by a logical, evidence-based discussion of the clinical and social realities. Such a discussion is only hindered by the growing fog of objections launched by mysterious organizations funded by the companies who have made the most money selling narcotics. So we also need some societal response to the growing domination of the public debate by marketing and public relations, often based on emotional manipulation, logical fallacies, and outright deception.
We cannot address our worsening health care dysfunction when public discussion and policy making blunders about in the fog of stealth health policy advocacy, stealth lobbying, and stealth marketing. If the leaders of big health care corporations really believe they are making good products and providing good services that add value and improve patients' and the public's health, they ought to be able to rely on honest and open communications. If they cannot disavow stealth public relations and stealth marketing, we ought to disavow the companies that practice them.
Not So Cheerful Musical Interlude
Unfortunately, given the topic of this post, here is Lou Reed singing Heroin
ADDENDUM (4 January, 2016) - This post was republished on the Naked Capitalism blog, sadly without Lou Reed. See the interesting comments appended to that version.
Also, this post was republished in its entirety on OpEdNews.
Mother Samantha Adams and her newborn Leopoldo Bautista,
10 days old, spend quality time inside the Louisville Norton Healthcare child care center for children experiencing drug
withdrawal. (Photo by Alton Strupp, The Courier-Journal)
Increasing drug abuse drove up hospitalizations of drug-dependent newborns in Kentucky by 48 percent last year, to 1,409 from 955 in 2013. "The latest numbers represent a 50-fold increase from only 28 hospitalizations in 2000," reports Laura Ungar of The Courier-Journal.
"The seemingly never-ending increase every year is so frustrating to see," Van Ingram, executive director of the state Office of Drug Control Policy, told Ungar. "It's a horrible thing to spend the first days of your life in agony."
"These infants are born into suffering," Ungar writes. "They cry piercingly and often. They suffer vomiting, diarrhea, feeding difficulties, low-grade fevers, seizures � and even respiratory distress if they're born prematurely."
Drug-dependent newborns are becoming more common nationwide, Ungar notes, but "Vanderbilt University researchers publishing in the Journal of Perinatology [a subspecialty of obstetrics concerned with the care of the fetus and complicated, high-risk pregnancies] say rates are highest in a region encompassing Tennessee, Mississippi, Alabama and Kentucky."
While the increase is blamed mostly on illegal drug use, the Vanderbilt study found that 28 percent of pregnant Medicaid recipients in Tennessee filled at least one painkiller prescription, Ungar writes: "Legitimate use not only raises the risk of having a drug-dependent baby, it can sometimes lead to abuse and addiction."
While Medicaid now pays for behavioral-health and substance-abuse treatment, "Drug treatment for pregnant women is sorely lacking," Ungar reports. In Kentucky, only 71 of the 286 treatment facilities listed by the U.S. Substance Abuse and Mental Health Services Administration treat pregnant women.
"Acute hepatitis B rose 114 percent in Kentucky, Tennessee and West Virginia from 2009 to 2013, even as incidence remained stable nationally, according to one study," she reports. "According to another study, the rate of new hepatitis C cases among people 30 and younger more than tripled from 2006 to 2012 in Kentucky, Tennessee, Virginia and West Virginia. More recently, cases of acute hepatitis B and C in Kentucky reached 281 last year, up from 120 in 2003."
