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Thousands of Latinos were sterilized in the 20th century. Amid COVID-19 vaccine hesitancy, they remember

NADA HASSANEIN | USA TODAY | 4:14 pm EDT March 16, 2021
Source: USA Today
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Source: USA Today
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The CDC says people who are fully vaccinated may get together with other fully vaccinated individuals in small groups without masks.STAFF VIDEO, USA TODAY

Consuelo Hermosillo’s 22-year-old granddaughter didn’t want to get a COVID-19 vaccine.

The office worker at a special needs center was afraid the shot would prevent her from ever getting pregnant.

The mistrust didn’t form out of thin air.

In 1973, Hermosillo, an immigrant from Mexico, worked a small catering business at home while her husband bartended and unloaded appliances at a department store. In November of that year, the 24-year-old went to a hospital for an emergency caesarian section to give birth to her third child.

The baby would be her last.

Hermosillo was sterilized without informed consent at the Los Angeles County-University of Southern California Medical Center.

“You better sign, or your baby is going to die,” she said a nurse told her.

Her signature is scribbled on aform allowing the procedure, but she doesn’t remember signing, saying she was medicated. She didn’t know she was sterilized until a doctor’s appointment later when she asked for birth control.

A whistleblower – a residentphysician later let go by the hospital – leaked that the practice occurred on many women. Hermosillo became one of 10 Mexican and Chicana plaintiffs in the landmark Madrigal v. Quilligan federal class-action case, which grabbed headlines in the mid-1970s. The judge sided with Dr. Edward James Quilligan, and the women lost, but the case inspired legislation passed in 1979 to abolish the practice in California. 

The Los Angeles County Board of Supervisors issued an apology in 2018 for the coerced sterilizations, but the women did not receive reparation money as victims did in other states, such as Virginia and North Carolina.

“As far as justice, they never received that,” said Virginia Espino, who documented the women’s stories as co-producer of a film called “No Mas Bebés,” (“No More Babies” in Spanish).

Consuelo Hermosillo says she was sterilized at a hospital without her knowledge.
Source: USA Today
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Consuelo Hermosillo says she was sterilized at a hospital without her knowledge. CLAUDIO ROCHA

Espino, a professor at the University of California, Los Angeles, and an expert in reproductive injustice, said it’s unclear how many women were sterilized at the LAC-USC medical center. The lawyer for the women who brought the lawsuit estimated “hundreds.”

Many didn’t speak fluent English and didn’t understand forms they signed, and in some cases, they werecoerced into signing. Many had labor complications and were told lies that they or their babies would die if they didn’t sign.

Insidious sterilizations didn’t occur inside that hospital only. Throughout the 20th century, about 20,000 women and men were sterilized in California alone under state eugenics policies, according to researchers, including University of Michigan professor Alexandra Minna Stern.The policies targeted patients of state-run asylums or group homes. A disproportionate number were Hispanic.

As COVID-19 vaccine rollout continues, hesitancy among vulnerable communities, including Hispanic people, is piqued – and history is unearthed.Experts and those within the communities say the skepticism partly stems from unethical medical practices that targeted people of color. Unwanted sterilizations didn’t occur just in California among Mexican women but among Black women in the South, as well as Native American women. It’s not a pretty picture’: Why the lack of racial data around COVID-19 vaccines is ‘massive barrier’ to better distribution.

From the 1930s through the 1970s, for example, about a third of the female population in Puerto Rico was sterilized under population control policies that coerced women into postpartum sterilization after their second child’s birth, according to the University of Wisconsin’s Office of the Gender and Women’s Studies Librarian annotated bibliography on the topic. The first large-scale clinical trial for contraceptives involved Puerto Rican women: In 1956, the pills were tested on poor women in Rio Piédras, a housing project in San Juan, according to a historical review published in the Canadian Family Physician journal. The women didn’t know they were experimental.

“Women who stepped forward to describe side effects of nausea, dizziness, headaches, and blood clots were discounted as ‘unreliable historians,’” wrote Dr. Pamela Verma Liao and Dr. Janet Dollin. The clinical trials involved pills with much higher hormone levels than today’s contraceptives. Despite the substantial positive effect of the pill, its history is marked by a lack of consent, a lack of full disclosure, a lack of true informed choice, and a lack of clinically relevant research regarding risk,” the authors said. “These are the pill’s cautionary tales.”Angelina Zayas, a pastor at Grace and Peace Community Church that serves Chicago’s majority-Hispanic Belmont Cragin enclave, says many Puerto Rican women in her community are afraid to take COVID-19 vaccines, citing memories of the sterilizations and experiments.

“The biggest one is fear,” said Zayas, who is Puerto Rican. “That’s something that they remember, which affects their judgment in getting the vaccination. They’re like, ‘Well, how can I trust?’”Consuelo Hermosillo listens to a recording of her voice from a trial three decades ago.CLAUDIO ROCHAWho is ‘worthy’ of having children?History’s cautionary tales didn’t stop the injustices from happening again.

Allegations of unwanted hysterectomies performed on mostly Hispanic women at Georgia’s Irwin Detention Center surfaced last year. From 2006 to 2010, more than 100 incarcerated women in California prisons, mostly Black and Latina, underwent hysterectomies without their consent. The Center for Investigative Reporting broke the news in 2013. 

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Researchers weren’t surprised.”If certain conditions are in place, and these are conditions that often include marginalized populations in carceral spaces, with little oversight of the authorities, those types of conditions can be ripe for sterilization abuse,” said Stern, author of the book “Eugenic Nation: Faults and Frontiers of Better Breeding in Modern America.”Essential health care: For the most vulnerable Americans, these clinics are trusted, accessible and vital to vaccine rollout“We are still very much living with … eugenic ideas of worth,” she said. “‘Who is worthy of having children, and who is worthy of raising children?’ Those are very much eugenic ideas that are alive and well, and they affect policy and harm certain people.”Under these policies, from 1907 through the 1970s, about 60,000 people underwent compulsory sterilizations nationwide.

Stern is studying a dataset of 30,000 sterilization records. She found that Latina patients in California were 59% more likely to be sterilized than non-Latinas. Hispanic men were 20% more likely to be sterilized than non-Hispanic men.The disproportionate operations, Stern said, were rooted in a racist ideology that certain attributes – criminal behavior, homosexuality, poor health, welfare usage or education levels – were hereditary and could be minimized through preventing procreation.An institutional evaluation of Andrea Garcia, 19, circa 1940, recommends sterilization. BACKSTAGE LIBRARY WORKS/CALIFORNIA STATE ARCHIVES Andrea Garcia, 19, from a Mexican family, was sterilized after being admitted into Pacific Colony, a psychiatric institution, for what evaluators called “truancy” and a low IQ test score.”Mentally deficient. Sex delinquent girl. Unfit home,” reads her evaluation, an archival copy of which is included in Stern’s analyses. “Father was illiterate; mother subnormal … one brother, four sisters thot to be subnormal.”At Pacific Colony, sterilization was a precondition for release – another coercive factor, Stern noted.

Sometimes people were released back to family members, sent to be helpers in households or perform menial labor jobs.Garcia’s mother took legal action but lost the case.Often, white women at the facility could escape the process, Stern said.”What you have is a system in place that is stratified in such a way that is most likely to bring in certain people. A young white girl with truancy could get away with it. Unlike Andrea Garcia. She didn’t have that luxury, a safety net, she didn’t have anything,” Stern said, calling the policies and practices “dehumanizing.”Women of color ‘robbed’ of agency, valueEspino, the historian who co-produced the No Mas Bebés documentary, said the abuses put women in unique difficulties. Some spouses didn’t trust that their wives were unwitting and thought they wanted the operations to be promiscuous. Factory worker Dolores Madrigal, the lead plaintiff in Madrigal v. Quilligan, said her husband took his anger out on her.

The sterilizations sent negative messages to women of color “that their mothering is not valued in the same way,” Espino said, “that they’re really only valued when they’re in the service of others: taking care of other people’s children or cooking for their masters. … Women of color’s bodies typically are valued when they’re used in the service of making other people wealthy.

The women, Espino said, were “robbed of their decision-making when it comes to the kind of family they want to have.”This man survived COVID-19: His treatment odyssey shows how complicated that can be.On a recent morning in California, Hermosillo, 71, took a break from babysitting and running the kitchens in her son’s four restaurants. Sitting on her porch in Venice, she reflected on the treatment of her and women like her. “I think they were doing it to lower the value of us Mexicans,” Hermosillo said. “That’s what I think.”She is grateful for her three children but dreamed of having more. As one of her fellow plaintiffs said, “Se me acabo la cancion” –”My song is finished.

Hermosillo’s older sisters had more children. As the family grew, she’d fall quiet when relatives asked when she would have more kids. She battled feelings of shame and embarrassment.“I hated baby showers,” she said. “Something happened to me.”As a girl in Mexico, she lived between her grandmother’s house and foster homes. She learned to be a mom at a very young age. As a teenager, she immigrated to the USA with her mother and spent her days looking after her baby brother.She didn’t tell her sisters or friends what happened at the hospital, sharing her story for the first time during the trial. She translated her love of babies and motherhood to working at the Women, Infants and Children (WIC) program for seven years, teaching breastfeeding classes to new moms.She wears a diamond necklace around her neck that she and her husband bought from one of her clients to help her with rent money.The struggle stays with her.“So many years passed,” she said, “but you don’t forget.”

Reach Nada Hassanein at nhassanein@usatoday.com or on Twitter @nhassanein_.

What questionable experiences have you had with medical professionals? What protections and regulations should be enforced or in place? What type of reparations should these women receive?

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Covid-19 Vaccine Hesitancy Is Worse In E.U. Than U.S.

Mar 8, 2021,10:23am EST|8,671 views

Joshua Cohen, Contributor
HealthcareI write about prescription drug value, market access, healthcare systems, and ethics of distribution of healthcare resources.
Source: Forbes
Photos Source: Forbes

Holding up hand to stop a COVID-19 vaccination syringe from approaching, an anti vaxxer person stands in the background
Across the E.U. vaccine hesitancy is worse than it is in the U.S. GETTY
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Throughout the Covid-19 pandemic, the U.S. has been somewhat of an outlier. With merely 4% of the world’s population, the U.S. accounts for more than 20% of globally reported deaths and nearly 25% of confirmed cases. But in the vaccination race the U.S. is proving to be a formidable competitor, having administered 30% of the world’s vaccine doses; approximately 26.3 doses per 100 people. Among Western industrialized nations only the U.K. has a better vaccination rate. Of those in the U.S. in the 65 and above age group, 59% have received at least one dose, and 69% of those over 75 have gotten at least one dose.

This is not to say that there aren’t issues with the vaccine rollout in the U.S. It’s been bumpy and uneven, with some states performing well and others lagging. Inequitable distribution across socioeconomic strata continues to be problematic. Moreover, the U.S. contends with an outspoken anti-vaccine movement.

But getting shots into the arms of European Union (E.U.) residents has proven to be much trickier. The U.S. is vaccinating at a faster pace than any member of the E.U., and three times the E.U. average.

Some of this can be attributed to better supply in the U.S. By contrast, Europe has faced unexpected manufacturing delays as well as a failure to procure sufficient inventory.

Thus far, most of the focus on explaining differences in vaccination rates has been on the supply side. So, for example, last summer the U.S. and the U.K. bought tens of millions of doses of several vaccine candidates prior to their emergency use authorization. The U.S. and U.K. didn’t know which vaccines would make it through the emergency use authorization process. But, both nations wanted to be sure they secured a supply so that once their respective regulatory agencies gave the go-ahead the initial batches would be immediately available. On the other hand, the E.U. took a much more risk-averse, wait-and-see approach, which meant that when the European Medicines Agency granted emergency use authorization there was little or no supply available at launch. The U.S. and U.K. gamble paid off, while E.U. dithering did not.

Yet supply is not the only factor impacting vaccination uptake. On the demand side, most of Europe is flailing while the U.S. is succeeding on the whole.

According to a recent Pew survey, nearly 70% of the U.S. public intends to get a Covid-19 vaccine or has already been vaccinated. This represents an impressive 10% jump in vaccine receptiveness in less than three months. Furthermore, a whopping 83% of registered Democrats are inclined to get vaccinated or have already received a coronavirus vaccine. Even among registered Republicans the numbers are improving, with a solid majority (56%) now saying they’re willing to get vaccinated or have already obtained a coronavirus vaccine. Independents fall somewhere between the Democrats and Republicans in terms of their vaccine receptiveness. Notably, the difference in vaccine receptiveness between black and white Americans has diminished since November. Sixty-one percent of black Americans now say they plan to get a Covid-19 vaccine or have already received one, up dramatically from 42% in November.

The numbers in the U.S. are significantly better than the E.U. Last month, in collaboration with the European Centre for Disease Prevention and Control, the RECOVER Social Sciences team published a policy brief based on their study on public views of Covid-19 vaccination. The study covered seven European countries: France, Germany, Belgium, Italy, Spain, Sweden, and Ukraine.

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Only 36% of the surveyed Europeans strongly agree with the statement that vaccines are safe. Posed the question whether respondents would be willing to be vaccinated if the vaccine was found to be safe and effective and provided free-of-charge, only between 44% and 66% answered in the affirmative. Moreover, a separate poll in France found that only 40% of French people want the Covid-19 vaccine.

Poll after poll conducted across Europe suggest very large numbers of Europeans have serious qualms about the safety of vaccines and potential short- and long-term adverse effects. They also voice concern about the speed with which vaccines went through the clinical development process. A vocal minority perceives the vaccine as unnecessary. And many have conveyed their mistrust of global and national authorities as well as pharmaceutical companies, who some regard as solely pursuing financial interests and not those of public health.

In Europe, even approved products that don’t necessarily have supply issues have faced stiff resistance. In France and Germany, for example, the approved AstraZeneca vaccine has an image problem, which means many are reluctant to take it, including healthcare workers on the front lines. Poor, inconsistent messaging has fueled the public’s confusion over the safety and efficacy of AstraZeneca’s vaccine. President Macron’s claim last month that the vaccine was “quasi-ineffective” for the elderly didn’t help matters. He has since reversed himself and is now pleading that people get vaccinated with whatever vaccine is available to them. But the damage was already done.

Europe’s degree of Covid-19 vaccine aversion is perhaps surprising, but not if one views it in the context of fiercely anti-establishment politics on the far-left and far-right, and a particularly virulent anti-science sentiment that existed long before Covid-19 hit. To illustrate, the far-right Lega and leftist Five Star Movement in Italy have both incited fearmongering about vaccines. Likewise, far-right and far-left political leaders in France, such as Le Pen and Mélenchon, have stoked anti-vaccine attitudes.

For Europe, the rising tide of vaccine hesitancy is coming at the worst possible time. In France and Italy cases and hospitalizations are increasing again. And, the situation is dire in the Czech Republic, which this week registered a record-breaking total of nearly 8,500 patients hospitalized with Covid-19. Also, Hungary’s prime minister declared last week that the country is in the midst of the worst two weeks of the pandemic.

Strong mitigation measures will need to continue across Europe to curb the spread, preserve healthcare system capacity, and save lives. Concomitantly, revamping a flagging vaccination campaign is critical. While boosting vaccine supply is a prerogative, tackling the widespread problem of vaccine hesitancy is equally important.

Have you taken the COVID 19 Vaccine? Why? Why not?

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Joshua P Cohen
Joshua P Cohen

I’m an independent healthcare analyst with over 22 years of experience analyzing healthcare and pharmaceuticals. Specifically, I analyze the value (costs and benefits) of biologics and pharmaceuticals, patient access to prescription drugs, the regulatory framework for drug development and reimbursement, and ethics with respect to the distribution of healthcare resources. I have over 110 publications in peer-reviewed and trade journals, in addition to newspapers and periodicals. I have also presented my work at numerous trade, industry, and academic conferences. From 1999 to 2017 I was a research associate professor at the Tufts Center for the Study of Drug Development. Prior to my Tufts appointment, I was a post-doctoral fellow at the University of Pennsylvania, and I completed my PhD in economics at the University of Amsterdam. Before pursuing my PhD I was a management consultant at Accenture in The Hague, Netherlands. Currently, I work on freelance basis on a variety of research, teaching, and writing projects. 

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As U.S. Corporations Face Reckoning Over Prescription Opioids, CEOs Keep Cashing In

March 28, 20217:00 AM ET
BRIAN MANN
Source: NPR

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Steve Collis, president and chief executive officer of AmerisourceBergen Corp., testifies during a House Energy and Commerce Subcommittee hearing on May 8, 2018.Bloomberg/Getty Images

Imagine you’re part of a project that goes horribly wrong at work, causing a scandal, costing your company a ton of money, maybe even putting people at risk. Now imagine after that kind of performance your company rewards you with a raise and a bonus.

Critics say that’s happening right now with CEOs at big drug and health care companies tangled up in the opioid crisis.

“When leadership fails … the board of directors have to be willing to hold their executives accountable,” said Shawn Wooden, Connecticut’s state treasurer.

His job includes investing state pension funds and other taxpayer money in firms that include some of the nation’s biggest drug makers and health corporations.

Wooden believes executives at some of those companies made risky decisions, leading their firms deep into the opioid business.

More than 450,000 Americans have died from opioid overdoses since drug companies began making, distributing and selling large quantities of prescription painkillers.

Now many firms face a tsunami of opioid lawsuits, have filed for bankruptcy, or find themselves on the hook for billions of dollars in settlements.

But Wooden says CEOs and other top executives keep getting rewarded.

A company loses $6.6 billion, a CEO is rewarded

Wooden points to a recent shareholder fight over compensation for Steve Collis, CEO of AmerisourceBergen since 2011.Article continues after sponsor message

The health services giant agreed to pay Collis $14.3 million for his work in 2020, a 26% raise. In that same year his firm reached a tentative $6.6 billion opioid settlement with state and local governments.

Wooden said that one opioid loss “nearly wipes out a decade, a decade’s worth of the company’s profits.”

He argues when calculating Collis’s pay, the company’s board should have factored in the loss along with the “reputational harm and the societal harm” caused by AmerisourceBergen’s opioid business.

Amerisource Bergen has admitted no wrongdoing as part of its settlement talks.

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In a statement to NPR, a spokesperson for the company said Collis was compensated appropriately based on the “pay-for-performance principle that executives should be rewarded when they deliver targeted financial results.”

But the company acknowledges that when calculating Collis’s performance, its board first excluded “litigation-related expenses.” Which means the whole opioid mess, everything related to “legal or compliance costs” was wiped from the ledger.

Despite objections by Wooden and Rhode Island state treasurer Seth Magaziner, a narrow majority of the company’s shareholders voted earlier this month to approve Collis’s compensation.

Collis isn’t alone. CardinalHealth, also on the hook for an opioid settlement worth roughly $6.5 billion, gave CEO Michael Kaufman a $2.5 million bonus in 2020.

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Purdue Pharma CEO Craig Landau testifies via video to a House Oversight Committee hearing on Dec. 17, 2020. Members of the family that owns OxyContin maker Purdue Pharma have acknowledged the drug had a role in the opioid crisis but have stopped short of apologizing or admitting wrongdoing.AP

Purdue Pharma CEO sees bonus after company guilty plea

Critics in Congress say one of the most troubling cases of drug executive compensation involves Dr. Craig Landau, CEO of Purdue Pharma, maker of OxyContin.

Landau has been an executive with the firm since the late 1990s and stepped into the top job in 2017. While admitting no personal wrongdoing, he’s named in dozens of opioid lawsuits.

In 2019, Landau led Purdue into bankruptcy and then last year his company admitted committing federal crimes linked to opioid sales.

Despite that track record, Purdue Pharma’s board rewarded Landau with a bonus worth nearly $3 million, a decision approved by a federal bankruptcy judge.

In December, while appearing before a congressional oversight committee, Landau faced calls to give the money back so it could be distributed to creditors and people harmed by the opioid epidemic.

“Will you forego this $3 million bonus you’re taking out of the pockets of the people who should get that money from the bankruptcy court?” asked Rep. Raja Krishnamoorthi, D-Ill.

“I have already made — willingly made — significant monetary concessions in order to move the bankruptcy process forward,” Landau testified.

“So the answer is no,” Krishnamoorthi said. “You want those $3 million at the expense of those opioid victims. Shame on you, Dr. Landau, shame on you.”

Landau voiced regret for the harm caused by OxyContin and again said he had done nothing wrong personally.

In a statement to NPR, Purdue Pharma praised Landau’s leadership and said he was compensated appropriately.

“Despite unprecedented headwinds, Dr. Landau has led the company and delivered results for its many stakeholders,” the spokesperson said.

Shareholders hurt by opioid reckoning

Charles Elson, an expert on corporate governance and ethics at the University of Delaware, said this kind of executive compensation at companies embroiled in a public health crisis leaves a bad taste.

“No matter how thick you slice it, it’s still the same old baloney,” Elson said, noting it is common for American corporations to reward executives with hefty bonuses even when things go wrong.

According to Elson, the financial pain for losses, like these billion dollar opioid settlements, typically gets passed along instead to average Americans who own stock in these companies.

“The shareholders are not simply a group of people on Wall Street, the shareholders are in fact all of us who were damaged as well,” Elson said. “I think that’s why it’s galling to see [executives] rewarded.”

The reality of the pharmecuitical industry is that it is a big business who has been paying fines for some time. How much of these fines are written into the cost of creating a drug and bring it to market? How much are these companies willing to pay and how many lives are they willing to see loss. How much can you afford to pay: drug management, disease management or death? Which one will you pay?

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Mediator trial: French pharma giant faces verdict on weight loss drug deaths

Issued on: 29/03/2021 – 04:59
Source: France 24

File Photo: Investigators accuse Servier of knowingly concealing the risks posed by Mediator for years.
File Photo: Investigators accuse Servier of knowingly concealing the risks posed by Mediator for years. FRED TANNEAU AFP/File
Source: France 24
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A French court will on Monday rule whether pharma giant Servier deliberately ignored warnings over a diabetes and weight loss pill blamed for hundreds of deaths, in one of France’s worst health scandals.

The drug Mediator was on the market for 33 years and used by about five million people before being pulled in 2009 over fears it could cause serious heart problems — more than a decade after such concerns had first been raised.

Over 6,500 plaintiffs, including France‘s health insurance funds, are seeking one billion euros ($1.2 billion) in damages from Servier, which is charged with manslaughter, causing unintentional injury, aggravated deceit and fraud.

Investigators accuse the drugmaker of knowingly concealing the risks posed by Mediator for years, allegations it denies. The first cases of heart disease linked to the drug were flagged in 1999, a decade before the drug was withdrawn.

A total of 12 people and 11 legal entities — Servier, nine subsidiaries and France’s medicine watchdog — were tried in late 2019 and early 2020 over their alleged role in a scandal that contributed to widespread distrust in France of the pharmaceutical industry.

Ten kilos in a month 

Servier’s former second-in-command, Jean-Philippe Seta, who faces possible jail time if convicted, admitted during the trial that Servier had “made mistakes”.

Initially intended for overweight people with diabetes, Mediator was widely prescribed to healthy individuals as an appetite suppressant.

Many of the victims who testified in court about the impact of the drug on their lives were women. Exhausted and out of breath, they recounted their stories sitting down. 

“It was said that the drug was extraordinary. I lost ten kilos the first month,” said one plaintiff, Stephanie, who took the drug for three years before being diagnosed with heart disease in 2009.

About 500 people are thought to have died as a result of the drug, though experts say it may eventually cause as many as 2,100 deaths.

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Thousands of victims have already reached settlements with the company, totalling nearly 200 million euros ($236 million), according to Servier.

France’s second-biggest drug company also faces criminal fines of around 10 million euros if found guilty of orchestrating a cover-up.

Watchdog failure 

The Mediator affair was the subject of the 2016 French film “150 Milligrams”, about the work of lung specialist Irene Frachon who was instrumental in bringing the alleged wrongdoing to light.

“I hope the court will give us the tools to understand how such deceit could have gone on for so long,” Frachon, who will be in court on Monday to hear the verdict, told AFP. 

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Servier and its former executive Seta claim they did not know the drug was dangerous until 2009 when it was withdrawn. 

By then it had already been outlawed in the United States, Spain and Italy. 

France’s medicine watchdog ANSM, which was tried over its delay in halting sales of the drug, has admitted to its “share of responsibility” in the scandal.

The other defendants include several consultants, who served on public bodies while being on Servier’s payroll, and a former right-wing senator accused of modifying a report on the scandal to downplay the company’s role in the affair.

(AFP)

Around the world and including in the United States we can see how profit drives the pharmaceutical industry, which has for sometime been creating disease to sell drugs to. Do you think this trend contributes to COVID 19 hesitation? Have you taken the COVID-19 Vaccine? Why or why not?

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Disease mongering and drug marketing

Shidonna Raven Garden and Cook

Howard Wolinsky
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Source: US National Library of Medicine – National Institutes of Health
Featured Photo Source: Unsplash, National Cancer Institute

Summary

Does the pharmaceutical industry manufacture diseases as well as drugs?

Most people may not have heard of metabolic syndrome, but that is likely to change. Once known mysteriously as Syndrome X, the condition, a precursor to heart disease and type 2 diabetes, is about to be transformed into a household name by the US pharmaceutical industry and its partners in the medical profession. A society dedicated to addressing the condition has been organized, a journal has been started, and an education campaign launched. Patients are already being tested for metabolic syndrome. As the trade publication Pharmaceutical Executive said in its January 2004 issue: “A new disease is being born” (Breitstein, 2004).

…industry has found itself under fire from detractors who contend that, in the pursuit of profits, companies are in league with medical doctors and patient advocacy groups to ‘disease monger’…

The situation is reminiscent of the attitude towards cholesterol. Twenty years ago, physicians were not concerned about the effects it might have on heart disease. Today, thanks to efforts by pharmaceutical companies, high cholesterol levels are now recognized as a major health problem. In fact, IMS Health, a global healthcare information company, reports that the two best-selling drugs in 2004 were statins: Lipitor® (atorvastatin calcium) from Pfizer (New York, NY, USA)—valued at US$10.6 billion with growth of 13.9% over the previous year—and Zocor® (simvastatin) from Merck (Whitehouse Station, NJ, USA). Pharmaceutical Executive noted: “The emergence of cholesterol reduction as a market was a major event for pharma. Metabolic syndrome promises to be as big or bigger” (Breitstein, 2004).

However, critics note that not every new disease for which the pharmaceutical business provides a drug is necessarily a major public health problem, but rather a venue for drug companies to increase revenues. Pharmaceutical companies research, develop and exploit drugs to prevent, control and cure diseases and treat symptoms. Companies then market these medications to recoup their investments and reward shareholders. It would seem to serve the interests of society, but some critics characterize it as a vicious circle in which businesses invent new diseases to match their existing drugs. Increasingly, industry has found itself under fire from detractors who contend that, in the pursuit of profits, companies are in league with medical doctors and patient advocacy groups to ‘disease monger’: convince people that their usually mild ailment urgently needs drug treatment.

The late medical journalist Lynn Payer addressed the issue in the early 1990s in her book Disease-Mongers: How Doctors, Drug Companies, and Insurers Are Making You Feel Sick. She wrote: “Disease-mongering—trying to convince essentially well people that they are sick, or slightly sick people that they are very ill—is big business…. Disease mongering is the most insidious of the various forms that medical advertising, so-called medical education, and information and medical diagnosis can take.” Similarly, Arthur Caplan, Professor of Bioethics at the University of Pennsylvania, Philadelphia, USA, last December told the popular American TV programme 60 Minutes, “If you want to stir up worry in the public, and you’ve got the advertising dollars to do it, you can turn almost anything into a disease.” The focus of the 60 Minutes report was the recent emergence of a market for adult attention deficit disorder (ADD)—the traditional view was that ADD afflicted only children who would eventually outgrow it.

Critics such as Payer and Caplan maintain that the routine human condition…is increasingly being re-defined as disease…

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Critics such as Payer and Caplan maintain that the routine human condition—unhappiness, bone thinning, stomach aches and boredom—is increasingly being re-defined as disease: depression in its milder forms, osteoporosis, irritable bowel syndrome and attention deficit disorder. Likewise, risks factors, such as high cholesterol and high blood pressure, are declared diseases in their own right—hyper-cholesterolaemia and hypertension—with falling thresholds resulting in more people considered to be sick. In other cases, drugs approved for devastating illness, such as clinical depression, are indicated for milder conditions, such as shyness, which is now dubbed ‘social phobia’.

One such example is Strattera® (atomoxetine hydrochloride), developed by Eli Lilly & Co. (Indianapolis, IN, USA) and approved in November 2002 by the US Food and Drug Administration (FDA) for treating ADD in children, teens and, for the first time, adults. One Lilly advertisement shows a series of photographs of an uptight-looking model, and asks in the headline: “Distracted? Disorganized? Frustrated? Modern Life or Adult ADD?” The advertisement notes that adult ADD can go undiagnosed because “its symptoms are often mistaken for a stressful life.” The commercial suggests that readers get checked out by their physician, because Strattera®, the first approved medication for adult ADD, can help “you stay focused, so you can get things done at work and at home.”

“I certainly have watched adult attention deficit disorder start to spread out from the first grade/kindergarten crowd right up to adulthood. I am suspicious because I think that this expansion is fuelled by Lilly and Strattera®,” Caplan commented. “I don’t like the way their website [suggests that] people go pester their doctor if they have problems waiting in lines or get frustrated being put on hold on the phone.” Lilly did not respond to a request for comment.

Adult ADD has been a favourite target of the critics. But psychiatrist Peter Jensen, a mental health researcher at Columbia University (New York City, NY, USA), concedes there is a dearth of epidemiological research on adult ADD, which can be a real condition that impairs and disables people. “Pharmaceutical companies are businesses that are out there to make money and sell things. But saying that diseases are invented seems a little over the top. [Companies] certainly spread information and increase awareness, but you can’t sell it to the FDA that way,” said Jensen, who serves on the governing board of Children and Adults with Attention–Deficit/Hyperactivity Disorder (CHADD; Landover, MD, USA), a non-profit patient support group. “Illness is defined in a social context. Value systems are inherent in medicine. With adult attention deficit disorder, some people whose brains are easily distracted are [annoyed] at being labelled [and] will say that they are just high energy and creative; others will be thankful they were diagnosed, treated and had their attention span restored to almost normal.”

…it is not only companies who are to blame, but also physicians who diagnose a disorder and prescribe a drug, as well as patients who feel that they have a serious disease that needs treatment

Not surprisingly, the pharmaceutical industry does not buy the ‘disease mongering’ critique. “Our [industry’s] job is to look for cures, not to create disease. It’s up to the medical community to develop new diagnostic tools and ways to evaluate patient response,” said Alan Goldhammer, Associate Vice President for Regulatory Affairs for Pharmaceutical Research and Manufacturers of America (PhRMA), an industry trade group based in Washington, DC, USA. He maintains that drug regulators, such as the FDA, approve drug therapies on the basis of clinical trials. “One can argue you can’t do a clinical trial because if it’s not a disease, it’s unethical to treat people with a drug if you’re not going to come up with any potential benefits. There are a number of checks and balances throughout the development process that are totally external to the pharmaceutical companies.”

Critics maintain that it is not only the pharmaceutical industry that has a role in the creation of new diseases, although they certainly fuel the process. For this reason, Australian journalist Ray Moynihan, a visiting editor at the British Medical Journal and co-author of the forthcoming book Selling Disease: How Drug Companies are Turning Us All into Patients, describes the process as ‘corporate-sponsored drug creation’ because it also involves physicians and patient groups. “There are informal alliances of doctors, drug companies and increasingly patient groups that help to widen the boundaries of illness in order to widen markets for those selling treatments. Often this process is driven by the medical profession, but it’s driven with fuel provided by the drug companies,” he said. Nevertheless, drug companies have an important role in the process. “The meetings where these disorders are defined and expanded are all drug-company funded,” Moynihan said. “Drug company activity lubricates this process, but it’s often not corporate executives in the driving seat. Often it’s the so-called thought leaders at the top of the tree in their profession and in their specialties.”

Furthermore, it is not always obvious where the border should be defined between a mild symptom and a disorder that needs medical attention. “I wouldn’t draw such a clean line between manufactured and real diseases,” said Joe Dumit, Associate Professor of the Anthropology and Science-technology Studies’ Programme at the Massachusetts Institute of Technology (Cambridge, MA, USA). He has been studying the topic of disease creation as part of his work on how patients with controversial sociomedical conditions, such as chronic fatigue syndrome, Gulf War syndrome and multiple chemical sensitivity, organized themselves to obtain research funding from the US National Institutes of Health. Dumit found that when patient groups were backed by pharmaceutical companies, such as patients with ADD and post-traumatic stress disorder (PTSD), the character of the debate changed entirely. “When Zoloft [®; sertraline hydrochloride] was approved [in 1999 for PTSD], almost every article that came out about PTSD now more or less no longer questioned the existence of the disease, but instead talked about the treatment and whether [PTSD is] underdiagnosed or overmedicated,” he said. In addition to forming alliances with patient groups, drug companies also attempt to “maximize the detectable prevalence of conditions as part of the economic rationale for growing the market for the medications,” said Dumit. “Once you decide on a threshold like a cholesterol level or an amount of irritation in your bowels, and once you decide there’s a drug that could reduce that in a population, they have a strong incentive to market to that whole population.”

One such example is social anxiety disorder, better known as shyness. GlaxoSmithKline (Uxbridge, UK) had the indications for its antidepressant Paxil® (paroxetine hydrochloride) extended to treat social anxiety disorder, an extreme form of shyness marked by fear of public speaking, eating in front of others or using public bathrooms. The FDA approved this new indication in October 2003. However, “shyness is a new disease invented by Glaxo,” said Sidney Wolfe, executive director of the Public Citizen’s Health Research Group (Washington, DC, USA). “In a pathological way I’m sure that people are so shy it can be a disease. It can be a real downside for people. A lot of these people are depressed. A number of these people are shy because they have been physically or sexually abused when they were younger. Shyness is generally a symptom of something else and to gloss over finding the cause and to just throw a drug at someone is doing a disservice.” GlaxoSmithKline did not respond to a request for an interview.

In the end, it is not only companies who are to blame, but also physicians who diagnose a disorder and prescribe a drug, as well as patients who feel that they have a serious disease that needs treatment. “What you have in social anxiety disorder is senior clinicians who are often connected with [several] different drug companies promoting this almost as a horrifying psychiatric disease,” Moynihan explained. He therefore lays some blame on the medical profession if they are not forthcoming about these connections. “I just don’t think you can be credible when you’re taking money from drug companies. And often when these [experts] are communicating with the public, the public does not know of those ties,” Moynihan said. “This is the marketing of fear. This is not a healthy way to run a society. It’s putting disease at the centre of human life.”

The USA is the epicentre for both drug and drug-marketing innovation. In addition, it is the only developed country apart from New Zealand that allows direct-to-consumer advertising for medications. According to Moynihan, consumers are exposed to an average of ten drug advertisements per day on news programmes, sitcoms and soap operas, which has a major impact on their view of disease. “The drug ads are changing perceptions of human ailments and conditions and experiences,” he said. Referring to the process in which disease prevalence is maximized, Moynihan cited GlaxoSmithKline’s campaign to market Paxil in the late 1990s, when pamphlets were distributed suggesting that one in eight Americans had social anxiety disorder. “One in eight Americans! This is clearly an absurd fiction. The point of that is to try and make ordinary people feel sick,” Moynihan said.

It’s not healthy for children or adults to sit in front of a wall of drug-company promotion every day that tells healthy people they’re sick.

Although other developed countries may not have direct-to-consumer advertising, they are not immune to the influence of marketing campaigns. “This is a global phenomenon,” Moynihan said. “In other countries, you can’t advertise drugs direct to the public, but you can run and sponsor disease awareness campaigns and that’s what they see in Europe and Australia.” In fact, in the autumn of 2003, Germany’s largest weekly news magazine Der Spiegel devoted a cover story on the topic, based on German science journalist Jörg Blech’s book Die Krankheitserfinder (The inventors of disease), which analyses how the pharmaceutical industry invents new diseases to increase sales of their drugs.

Jerry Avorn, a medical professor at Harvard University and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women’s Hospital (Boston, MA, USA), is a long-time critic of the drug industry’s marketing practices. However, he is also sceptical of the social critics: “The reason we’re not still using leeches is we base our decisions about drugs on well done clinical trials of what works and what doesn’t. Nothing that comes out of the realms of anthropology or philosophy matters much if the science isn’t taken into account.” According to Avorn, there are two extremes in the discussion: those who overpromote the pill-for-every-ill philosophy and nihilists who view diseases as being invented. “The truth is somewhere in the middle,” he said.

Faced with increasing costs for healthcare services to cover drug prescriptions, politicians have also begun to investigate the issue of disease mongering. In 2004 and 2005, the British House of Commons held hearings on practices of the pharmaceutical industry, including disease mongering. In March 2005, the House of Commons Health Committee published a report, The Influence of the Pharmaceutical Industry, in which it expressed concerns about the effects of “medicalisation of our society—the pill for every problem.” The committee did not blame this trend solely on the pharmaceutical industry, but rather said the industry has encouraged it by acting as a “’disease monger’, with the aim of categorising an increasing number of individuals as ‘abnormal’ and thereby requiring (drug) treatment. This process has lead to an unhealthy over-reliance on, and an overuse of, medicines. It also diverts resources and priorities from more significant disease and health problems” (House of Commons, 2005).

To increase people’s awareness of disease mongering, Moynihan called for “a more robust conversation” on regulation. “The disease-awareness campaigns need to be seriously regulated. It’s not healthy for children or adults to sit in front of a wall of drug-company promotion every day that tells healthy people they’re sick,” he said. “I actually think quite strongly that there must be a conversation about how or if to regulate this. I think that’s extremely unlikely [in the USA] in the near future. I think the Europeans are a little more civilized about this stuff. And in fact the Europeans recently rejected loosening the rules on advertising.” As governments and public healthcare systems are increasingly confronted with the high cost of medications, no doubt the issue of medicalization and disease mongering will become even more important in future debates.Go to:

References

  • Breitstein J (2004) The making of a new disease. Pharma Exec 1 Jan, www.pharmexec.com [Google Scholar]
  • House of Commons (2005) The Influence of the Pharmaceutical Industry. Fourth Report of Session 2004–2005, HC 42-I. London, UK: The Stationery Office Limited [Google Scholar]

This interesting article from the health care industry discusses the huge push of the pharmaceutical industry to create disease and prescribe drugs motivated by profit. What medicines / drugs do you take? Why? How did you obtain the disease to require the medication?

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Scandal over COVID vaccine trial at Peruvian universities prompts outrage

NEWS  26 MARCH 2021
Researchers gave shots to politicians and family members, violating trial regulations — and damaging public trust.
Source: Nature

Luke Taylor

Martin Vizcarra speaks to the press.
Former Peruvian president Martín Vizcarra was the first prominent person identified by local media to have received a COVID-19 vaccine in violation of clinical-trial standards.Credit: Ernesto Benavides/AFP/Getty
Source: Nature
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A clinical trial of COVID-19 vaccines in Peru has sparked outrage and triggered a series of high-profile resignations at universities and in government. Politicians, researchers and some of their family members who were not enrolled as trial participants nevertheless received vaccines — breaching standard protocols. Investigations are ongoing as the country struggles to inoculate its general population with limited doses.

The scandal emerged on 10 February, when local media revealed that in October 2020, then-president Martín Vizcarra had received two doses of a vaccine developed by the Chinese state-owned pharmaceutical group Sinopharm. At the time, a phase III clinical trial was under way to test the vaccine at two universities in Peru; Vizcarra was not part of the trial.

Days later, it emerged that a group of around 470 other people — including 100 high-profile individuals such as Peru’s minister of health and Vizcarra’s wife and brother — also got a jab while the trial was in progress. The shots came from a batch of about 2,000 doses that Peruvian officials reportedly negotiated with Sinopharm to protect the medical staff running the trial.

It is not standard practice to vaccinate anyone other than trial participants while a trial is under way — including the medical staff running it, says Euzebiusz Jamrozik, a bioethicist at the Ethox Centre at the University of Oxford, UK.

The laws regulating clinical trials in Peru state that imported, experimental research products such as unapproved vaccines are to be used exclusively for research.

One of the universities running the trial — the National University of San Marcos in Lima — issued a statement condemning the vaccinations of people not enrolled as participants. “Normative and ethical principles of the current regulations and good clinical practices [a set of international medical standards] have been flagrantly violated by using the vaccine in people who are not subjects of research,” said the university’s Faculty of Medicine.

On 19 February, Peru’s National Health Institute (INS) suspended the second university involved, Cayetano Heredia University in Lima, from running new clinical trials. Cayetano has since appointed a panel of former faculty members to investigate the breaches of protocol.

Both universities’ rectors were among the group of non-participants who received shots. Cayetano’s has resigned, but San Marcos’s has not, sparking student protests.

“We share the indignation and deep pain of the [university] community and Peruvian society over the events related to the administration of the additional batch of experimental vaccines sent by Sinopharm,” said Cayetano’s new rector and vice-rector of research in a press release on 1 March.

Nine members of Peru’s Congress have been appointed to oversee an investigation into the vaccinations.

The violation of protocol, and what is seen by many as an abuse of political power by senior officials, has dented confidence in Peru’s politicians and its scientific community, says Mateo Prochazka, a Peruvian epidemiologist working in the United Kingdom. “At a time when we’re creating policies to control the transmission of the virus, we need the public to trust institutions and science, so this is a huge blow for our pandemic control,” he says.

Negotiated doses

The scandal and investigations follow a period of political instability for Peru, in which Vizcarra was impeached and removed from office over bribery charges. The country is struggling to contain the COVID-19 pandemic: it has officially reported more than 1.4 million cases of COVID-19 and 50,000 deaths. That’s the largest number of deaths by population size in Latin America, according to the COVID-19 tracker run by Johns Hopkins University in Baltimore, Maryland.

A health worker in protective gear administers a vaccine to another wearing scrubs, a mask and goggles.
A health-care worker in Peru receives a dose of the Sinopharm vaccine.Credit: Luka Gonzales/AFP/Getty
Source: Nature

The public had seen the vaccine trial, and a subsequent deal for 38 million Sinopharm vaccine doses to distribute in Peru, as a turning point in the battle against COVID-19. As in other low- and middle-income countries, Peru paved a path for itself to obtain vaccines by running the trial. It began administering 300,000 of the Sinopharm doses to health-care workers in February.

When news of Vizcarra’s vaccination came out, he said he had made the “brave decision” to volunteer for the trial. But Cayetano and the INS have since confirmed that he and the other prominent people who received vaccinations from October onwards were not among the study’s 12,000 participants — half of whom received placebos.

Nature’s requests for comment from Vizcarra went unanswered. In a press release from February, Vizcarra said it was a “great surprise” that Cayetano had not included him as a trial participant, and that he did not make his vaccination public “since it would have jeopardized the normal development” of the trial.

Trial oversight

The researcher leading the clinical trial was Germán Málaga — an internal medicine specialist at Cayetano who is a prominent figure in the medical community.

He oversaw the administration of some of the doses to politicians, including personally attending the vaccination of Vizcarra and his wife at the presidential palace after they requested it, he told a congressional committee investigating the vaccinations on 16 February. He also gave shots to members of his own family.

Cayetano has suspended Málaga from his role as principal investigator of the trial, and from all university activities.

Málaga denies that he broke protocol in administering vaccines to researchers and prominent people. He points out that the trial protocol he wrote states that the additional batch of vaccines would be “administered voluntarily to the research team and study-related personnel”.

The INS approved this protocol. It did not respond to Nature’s requests for comment.

Málaga tells Nature: “We used as criteria the protection of ‘study personnel and related personnel’ in a broad way, and in that extension we included the network of infections of the people we wanted to protect.” He admits that this included members of his family but points out that it also covered medical staff who were working on the front line and thus, in his opinion, needed protection.

According to a press statement released by the INS, Málaga and his staff also administered three doses, rather than the prescribed two, to some inidividuals outside of the trial, to see whether an additional booster shot would improve protection against the coronavirus.

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In response to Nature’s queries about administering unauthorized doses, Málaga defended his choice. He pointed out that when he administered the shots last September and December, the Sinopharm vaccine had not yet been proved efficacious, and thus trying out extra doses on individuals wouldn’t have been taking them away from the public.

“Including an additional dose is a serious, arbitrary breach of protocol” and violates the “fundamental principles of medical ethics,” says Ignacio Maglio, coordinator of science ethics for the UNESCO Bioethics Network who is based in Buenos Aires, Argentina. “It’s a clear example of malpractice in scientific study that could affect the safety of patients and puts at risk the dignity, the integrity and the safety of the research subjects.”

Failed transparency

Clarifying how and why vaccinations were administered outside the trial could help restore confidence in Peru’s science community, says Prochazka, but investigations are complicated by the fact that so many institutions are implicated.

The events in Peru aren’t the only instances in which members of the elite have jumped vaccine queues during the pandemic. In Argentina, for example, a similar list has emerged, resulting in the health minister’s resignation and a national investigation.

Arthur Caplan, head of New York University’s Division of Medical Ethics, says it makes sense to prioritize state leaders such as presidents and prime ministers for vaccines, but there has to be “a clear, principled approach to distribution” — and transparency.

“The Peruvian case seems to be at the extreme of ethical outrage,” he says. “Vaccinations have to be built on trust, not who you know.”doi: https://doi.org/10.1038/d41586-021-00576-0

Historically the health care industry is riddled across the world with unauthorized and unethical testing and experimentation. COVID-19 as we can see is no exception. When such things come to the public often an apology and reparations ensue, and many would like to tell us that such behavior is apart of the past and trust these new vaccines such as COVID-19. As we can see these things occur today amidst the COVID-19 Vaccine. Often when the unknowing participants are made aware of their involvement in medical trails or experiments, the damage has already been done and in some cases that is death. In fact some medical professionals blame the results of medical treatments on pre-existing conditions. How can this be disclosed if the person does not know they are in a trail or being experimented on.

Should people be told when they are apart of clinical trails? How can someone unaware of their own medical history properly communicate and manage their current and historical health? What disclosure and protections be in place? What happens when they fail?

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A Continued Legacy of Healing

Martin Luther King Jr. inspired a nation to change

January 15, 2020 by SSM Health
Source: SSM Health
Photo(s) / Image(s) Source: SSM Health

Dr. Martin Luther King Jr. dedicated his life to serving others through a message of peace, non-violence and what he called the Beloved Community; all of these being rooted in love.

He was a voice for the voiceless. A beacon of hope in a confused world. He became a  symbol of strength for an entire nation and beyond.

Now, more than 50 years after his death, Dr. King’s legacy continues to guide us on matters of morality, equality, human dignity and diversity.

IC_MLTI_15_141824_R07_MLK_2020_dTV_1366x768_FINAL-(1).jpgThe Civil Rights leader inspired change with his nonviolent approach to inequality and injustice. From the struggle to end apartheid in South Africa, to the effort to break up Soviet occupation in Poland, Dr. King began a movement that extended far beyond his Civil Rights work and even his own lifetime.

His work continues to energize, motivate and guide those on a mission for justice and healing in the world. Those determined to reach beyond the status quo, overcome life’s hurdles, and create lasting change for good.
And that change doesn’t happen when we are comfortable or complacent. It happens when we recognize that only we can make a difference, and in fact, must make a difference. Change happens when we recognize the opportunity to do better. Be better. Lead better.

SSM Health believes diversity makes us stronger and allows God’s presence to be revealed. We believe a diverse work community allows the gifts of all to contribute to the best outcomes. Our success lies in diversity. It’s part of our past and the key to our future.

“We are not makers of history. We are made by history.”
– Martin Luther King Jr. 

In 1933, SSM Health’s founding sisters, the Franciscan Sisters of Mary, opened the nation’s first Catholic hospital for African Americans. St. Mary’s Infirmary welcomed African American patients, but also gave African American physicians and nurses a place to be trained and to practice their professions. These sisters were following in the footsteps of their foundress, Mother Mary Odilia Berger and the first sisters who came to St. Louis from Germany in 1872 to immediately began caring for the sick and the poor in the midst of a smallpox epidemic.

The sisters did what they believed God was calling them to do. They cared for people in their homes, especially the poor who did not have money to be cared for in hospitals. They recognized the dignity of each person and brought healing to society’s most vulnerable with compassion and care. We continue to be inspired by their courage and commitment at SSM Health today.

Our founding sisters were trailblazers. They began a health care ministry that today is stronger and larger than they could ever have imagined. They were advocates for the poor and vulnerable, and their lives and ministry inspire us to carry on their legacy in the communities we serve.

 “Life’s most persistent and urgent question is, ‘What are you doing for others?”
-Martin Luther King Jr.

Martin Luther King Jr. Day is a national day of service when we are all encouraged to celebrate by committing to improve the lives of others. So we ask you, what are you doing to serve others?

Because after all, “everybody can be great … because anybody can serve. You don’t have to have a college degree to serve. You don’t have to make your subject and verb agree to serve. You only need a heart full of grace. A soul generated by love.”  – Martin Luther King Jr. 

How can service be a source of healing and greatness for you? What other leaders have offered healing to a nation and an world? How?

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The truth about opioids

Shidonna Raven Garden and Cook

Dec. 14, 2020
Source: Truth Initiative
Featured Photo Source: Unsplash, Michael Longmire

truth® public education and prevention campaign is helping young people understand the dangers of opioid misuse

The Truth About Opioids, a nearly three-year-long effort from Truth Initiative to contribute its youth prevention and education expertise to combatting America’s opioid misuse epidemic, is helping young people understand the facts about opioids, the risk of addiction and the crucial role they can play in solving the crisis within their communities. Evaluations of the campaign show shifts in young people’s knowledge and attitudes about the dangers of opioid misuse and around opioid use disease stigma, underscoring the importance of public education and prevention — alongside emergency response, treatment and recovery — in the comprehensive effort to combat the epidemic.

Young Americans are especially vulnerable to misunderstanding the risks associated with opioid misuse, addiction, and the dangerous spiral down from prescription to illicit use. An estimated 1,300 young adults misused an opioid prescription for the first time each day in 2018 and overdose deaths in the U.S. continue to climb after reaching record numbers in 2019, exacerbated by the COVID-19 pandemic. Truth Initiative began confronting this crisis in 2018 because of its record of success in tobacco prevention — the organization has prevented over 3 million youth and young adults from smoking since 2000 and helped bring the youth cigarette use rate down from 23% in 2000 to a historic low of 3.7% in 2019 — and the recognition and credibility of the truth brand, which has nearly 80% awareness among young people.

Truth Initiative developed The Truth About Opioids using its proven-successful tobacco prevention strategy — giving young people the facts and empowering them to make their own decisions — based on formative research and rigorous evaluation. Research that found a significant knowledge gap about opioids and their risks, as well as a desire among young people to be part of a solution, guided the campaign’s focus on achieving key outcomes: increasing awareness of the risk of misuse, decreasing stigma of addiction to help young people understand it can happen to them, and driving them to seek and share more information. The campaign, which featured a series of different messages, was rigorously tested both before messages were placed in market and in national and focused local markets after airing. The pre- and post-market evaluations of different components of the campaign show that it is achieving these key outcomes among its target audience:

  • Increasing opioid misuse awareness: The campaign drove a 46% increase in those who strongly agreed that opioid dependence can happen in just five days among young people who engaged with the campaign and a 27% decrease in those who strongly agreed with the statement “If I got a prescription opioid from a doctor, I would share some with my friends.” Nearly three-quarters (73.7%) of youth and young adults perceived using opioids without a prescription even once or twice as “high risk,” an increase from 66%.
  • Decreasing stigma: There was a 36% increase in those who strongly agreed that anyone can become addicted to prescription opioids and a 20.6% increase in the number of young people who said someone like them could become dependent on prescription opioids.
  • Prompting intentions to seek and share information: Young people were 600% more likely to search for the terms “opioid epidemic” and the campaign tagline, “know the truth” after seeing the campaign. There was a 20.4% increase in those who reported intending to talk to a friend or loved one about their opioid use and an 11.5% increase in those who intended to look up information about the opioid epidemic.

The campaign has also received recognitions for its creativity and effectiveness, including an Emmy award. This report details the development, evaluation, and future of the campaign.

Download the truth about opioids one-page overview

Do you know someone who is addicted to opioids or prescription drugs? How has this article helped them? How can you prevent prescription drug addiction?

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Lessons from Corporate Influence in the Opioid Epidemic: Toward a Norm of Separation

Shidonna Raven Garden and Cook

J Bioeth Inq. 2020 Jul 13 : 1–17.doi: 10.1007/s11673-020-09982-x [Epub ahead of print]PMCID: PMC7357445PMID: 32661741

Jonathan H. MarksAuthor informationArticle notesCopyright and License informationDisclaimer
This article has been cited by other articles in PMC.

Source: National Institutes of Health
Featured Photo Source: Unsplash, Piron Guillaume

Abstract

There is overwhelming evidence that the opioid crisis—which has cost hundreds of thousands of lives and trillions of dollars (and counting)—has been created or exacerbated by webs of influence woven by several pharmaceutical companies. These webs involve health professionals, patient advocacy groups, medical professional societies, research universities, teaching hospitals, public health agencies, policymakers, and legislators. Opioid companies built these webs as part of corporate strategies of influence that were designed to expand the opioid market from cancer patients to larger groups of patients with acute or chronic pain, to increase dosage as well as opioid use, to downplay the risks of addiction and abuse, and to characterize physicians’ concerns about the addiction and abuse risks as “opiophobia.” In the face of these pervasive strategies, conflict of interest policies have proven insufficient for addressing corporate influence in medical practice, medical research, and public health policy. Governments, the academy, and civil society need to develop counterstrategies to insulate themselves from corporate influence and to preserve their integrity and public trust. These strategies require a paradigm shift—from partnerships with the private sector, which are ordinarily vehicles for corporate influence, to a norm of separation.Keywords: Opioids, Corporate influence, Public-private partnerships, Conflict of interest, Institutional integrity, Public health ethics

The opioid epidemic has claimed the lives of more than 400,000 Americans in the last two decades (CDC 2019a). It has devastated families, destroyed entire communities, and drained the resources of social services. Opioid addiction and deaths impose societal costs that, in the United States alone, are now measured in the trillions of dollars (CEA 20172019), with many of these costs falling on underfunded local and state government agencies. In recent months, much evidence has emerged demonstrating the ways in which opioid companies’ strategies of influence fuelled the crisis. Companies built relationships with a variety of individuals and institutions: physicians, professional societies, patient advocacy organizations, research universities, public health agencies, and legislators. Although the impact of these strategies has been most closely observed in North America, their reach is international.

Previous analyses of corporate influence in the pharmaceutical sector make clear that the opioid companies’ strategies are not entirely novel (see, e.g., Applbaum 2009). Some of the leading case studies should have been cautionary tales because they also involved prescription medicines for the treatment of pain (see, e.g., Steinman et al. 2006; Ross et al. 2008). A number of corporate strategies were honed within the drug and medical device sector—for example, hiring “medical education and communication companies” (or MECCs) to shape the evidence required for the approval and promotion of new products and recruiting physicians as “key opinion leaders” (KOLs), a title designed to be psychologically rewarding, and paying them to deliver scripted promotional presentations to their peers (Sismondo 2018; Sah and Fugh-Berman 2013). But many strategies were developed with the advice and guidance of the kinds of entities—public relations, management consultancy, and crisis management firms—that were previously hired by tobacco companies and other industries to cast doubt on the harms caused by their products or commercial practices (see, e.g., Michaels 2008; Armstrong 2019; Michaels 2020). These strategies are both extensive and comprehensive, involving webs or networks of relationships with government, the academy, and civil society (Marks 2019a). Although relationships are widespread at institutional levels, media attention tends to focus on individuals—most commonly, excoriating doctors and researchers for failing to disclose that they have industry-related financial conflicts of interest.

The focus on “naming and shaming” individuals, even when warranted, threatens to downplay or ignore a systemic problem: institutional and societal cultures and practices that embrace partnership with industry and, wittingly or unwittingly, promote companies’ products, increase brand loyalty, burnish corporate reputations, defuse support for the regulation of companies’ products and marketing practices, and reinforce the framing of public health problems and their solutions in ways that are least threatening to the commercial interests of those companies (Marks 2019a). Nowhere is this more evident than in the origins of and responses to the opioid crisis, where collaborative efforts to address pain management—an important and historically neglected problem in medicine and public health—have profoundly exacerbated another major public health challenge, addiction (see, e.g., Meier 2018; Macy 2018; McGreal 2018).

Opioid companies’ strategies were designed to expand the prescribing of opioids from terminal cancer patients to a larger and more lucrative population: patients with non-cancer-related acute and chronic pain—despite lack of evidence of efficacy in relation to the latter. Companies promoted—some would say pushed—higher doses of opioids in order to increase profits further, while downplaying the risks of addiction and abuse. In addition, companies framed both doctors and patients as the problem. Physicians who had legitimate concerns about the addictive properties of opioids were characterized as having “opiophobia.” This term, coined by Purdue Pharma, the manufacturer of arguably the most well-known prescription opioid, OxyContin, later found its way into guidelines of the World Health Organization (WHO) (Clark and Rogers 2019). These guidelines remained in effect for the better part of a decade until they were “discontinued” by the WHO in June 2019 in the wake of revelations of corporate influence (WHO 2019). Patients who became addicted were, of course, not characterized as victims of an aggressive marketing and public relations strategy. When Richard Sackler was president of Purdue Pharma in 2001, he urged colleagues to blame and “hammer” patients, describing them contemptuously as “abusers,” “culprits,” and “reckless criminals” (Zezima and Bernstein 2019).

Most of the media attention has focused on Purdue Pharma—and on members of the Sackler family who are major shareholders.1 However, it is important to keep in mind that this company was only one of several drug companies that promoted their opioids by building webs of relationships with a variety of public health agencies, academic institutions, and public health NGOs, as well as thousands of individual health professionals. A recent trial in Oklahoma shed light on the activities of Johnson & Johnson, a family of companies that has not only sold its own opioids but also supplied the active ingredients to several other opioid companies, including Purdue Pharma (Hoffman 2019a2019b). For that reason, Johnson & Johnson had an additional incentive to engage (and did engage) in the unbranded promotion of opioids. The criminal trial of the former executives of another company, Insys, also shed light on its fraudulent marketing practices (Emanuel and Thomas 2019). We know more about the “webs of influence” woven by these companies than about the strategies of other companies that have been more successful, thus far, at keeping evidence out of the public domain—often by settling cases before they go to trial. But there is clear evidence that aggressive promotion strategies were widespread, to varying degrees, across the opioid industry (Horwitz et al. 2019). Building on other recent work (Marks 2019a2019b2019c), I will tease apart some strands of the known webs of influence of the opioid industry before reviewing the cumulative effects and exploring the ethical and policy implications.

Influencing Physicians and Health Professionals

Arthur M. Sackler died in 1987, long before Purdue Pharma’s 1996 launch and subsequent aggressive marketing of its leading opioid brand, OxyContin. But the roots of pharmaceutical marketing to physicians go back seven decades (Greene and Podolsky 2009), and Sackler was a vital rhizome (Podolsky, Hertzberg, and Greene 2019). He may not have invented the practice of medical marketing but, as the Medical Advertising Hall of Fame put it: “No single individual did more to shape the character of medical advertising than the multi-talented Dr. Arthur Sackler. His seminal contribution was bringing the full power of advertising and promotion to pharmaceutical marketing” (Podolsky 2015, 25). The extent and efficacy of opioid marketing in recent years has arguably gone far beyond Sackler’s wildest dreams or, more charitably, his worst nightmares.

Between 2014 and 2015, roughly one in seven physicians in the United States received opioid-related gifts from pharmaceutical companies (Hollander et al. 2019); another analysis of a similar period puts the figure for family physicians even higher at one in five (Hadland, Krieger, and Marshall 2017). During this time, physicians wrote more than seventy opioid prescriptions per year for every hundred Americans (CDC 2019b). Unsurprisingly, studies have found the receipt of payments from opioid companies is associated with increases in physicians’ prescribing rates (Hadland et al. 2018; Hollander et al. 2019). That is, of course, the reason drug companies engage in such practices, and similar effects have been found in relation to a variety of other prescription drugs. But disturbing recent research reveals why, in the case of opioids, the resulting increase in prescribing is especially problematic. A study of 67,507 physicians in 2,208 counties across the United States between 2013 and 2015 concluded that drug companies’ marketing of opioids to physicians was associated with not only increased opioid prescribing but also elevated mortality from overdoses (Hadland, Rivera-Aguirre, and Marshall 2019). More troubling still, court documents recently filed by the Attorney-General of Massachusetts allege that doctors who met with Purdue Pharma drug reps were ten times more likely to have prescribed opioids to patients who later died of an overdose than physicians who prescribed opioids without having met the company’s drug reps (Attorney-General of Massachusetts [A.G. Mass.] 2019; Joseph 2019a).

In February 2018, Purdue Pharma said it would stop marketing opioids to physicians (Poston 2018). But we should not derive any comfort from these kinds of voluntary commitments. First, the Massachusetts court documents make clear that the company continued its aggressive marketing strategy for at least a decade after it pleaded guilty in 2007 to misleading physicians and patients by downplaying the risks of addiction and abuse of its leading brand, OxyContin (Meier 2007). That strategy was complemented by an insidious kickback scheme: Purdue Pharma paid a technology company to generate prompts in electronic health records (EHR) software encouraging physicians to prescribe more opioids (Farzan 2020). Second, a consortium of companies known as Mundipharma, also owned by members of the Sackler family, has been making efforts to expand opioid markets internationally. While some of Mundipharma’s apparent practices in China go beyond what has been alleged in the United States, the broad strategy of downplaying the risks of addiction and abuse clearly resembles Purdue Pharma’s North American strategies (Kinetz 2019). As former U.S. Food and Drug Administration (FDA) commissioner David Kessler observed, “It’s right out of the playbook of Big Tobacco. As the United States takes steps to limit sales here, the company goes abroad” (Ryan, Girion, and Glover 2016, ¶9).

Purdue Pharma is just one of several opioid manufacturers that have been making payments to physicians (see, e.g., Hollander 2019)—and it is not the only company to have engaged in the aggressive marketing of opioids (Horwitz et al. 2019). A U.S. Senate report describes in some detail how another company, Insys, engaged in similarly aggressive practices (Homeland Security and Government Affairs Committee [HSGAC] 2018b). The report revealed that executives emphasized to their sales reps the importance of “owning” physicians and of “holding the customer [that is, the physician] accountable” when they failed to sustain or increase sales of Subsys, a fentanyl brand. The company’s new CEO informed the Senate Committee that the company had learned from past mistakes and replaced most of its sales force. But in the wake of multiple indictments, congressional investigations, civil lawsuits, and much highly critical media attention (see, e.g., Woodson 2019), this is too little too late. It remains to be seen whether the conviction of several former Insys executives for fraud—and the prospect of imprisonment for several years—will change corporate cost-benefit analyses in ways that previous fines on companies have not (Emanual and Thomas, 2019; Raymond 2019; Thomas 2020).

Influencing the Academy: Universities and Academic Medical Centres

Several academic institutions and universities received donations from opioid companies, and corporate philanthropy sometimes dove-tailed with individual philanthropy (Joseph 2019b; Associated Press 2019). Notably, both Purdue Pharma and members of the Sackler family made gifts to universities and teaching hospitals. While the history of this philanthropy predates the launch of OxyContin, the gifts intensified thereafter. In 1980, three Sackler brothers established the Sackler Graduate School of Biomedical Sciences at Tufts University (A.G. Mass. 2019). In 1999, three years after the launch of OxyContin, family members made a more targeted gift to Tufts to establish a Master’s of Science in Pain Research, Education, and Policy (A.G. Mass. 2019). In 2002, Purdue Pharma also gave $3 million to the pain centre at Massachusetts General Hospital (MGH), which was renamed the “MGH Purdue Pharma Pain Center” (AAAS 2002).

Remarkably, academic institutions continued to accept donations from and build relationships with Purdue Pharma after the company and several of its executives had pleaded guilty in 2007 to misleading doctors and patients about the addiction risks of OxyContin (Meier 2007). A recent independent review (commissioned by Tufts) found “no evidence of any meaningful attempt by Tufts to reconsider its relationship with, or distance itself from, the Sacklers or Purdue” in the wake of the guilty plea—or at any time prior to the publication in autumn 2017 of high-profile magazine articles severely criticizing Purdue and members of the Sackler family (Yurko and Remz 2019, 10; Keefe 2017).

Tufts was not the only academic institution to accept gifts from Purdue Pharma after the 2007 guilty plea. In 2010–2011, MGH received an additional $3 million gift for its pain centre. Around this time, the company also made gifts to promote opioids in programmes at a dozen institutions in Massachusetts alone. These gifts included five-figure sums to Boston University, Northeastern University, and Massachusetts College of Pharmacy (A.G. Mass. 2019). The donations made sense from the donor’s perspective—at a time when opioid companies were coming under greater scrutiny, these relationships gave Purdue Pharma opportunities not only to influence students and doctors but also to burnish the company’s reputation. But these gifts were extremely perilous to the integrity of and public trust in the recipients—as well as patient health.

Contemporaneous documents make these perils strikingly clear. In 2014, when Purdue’s medical liaison staff succeeded in getting two “unbranded curricula” approved for teaching Tufts students—described by the university as “the next generation of leaders in the field of pain”—the accounts team congratulated their colleagues for “penetrating this account” (A.G. Mass 2019, ¶285). In 2015–2016, the Tufts University School of Medicine decided not to assign as the “Common Book” for all incoming medical students, Sam Quinones’ Dreamland (2006), “in significant part” because the book criticized Purdue Pharma for its role in the opioid crisis and there was a “desire to avoid controversy” in the donor relationships with Purdue Pharma and the Sackler family (Yurko and Remz 2019, 23). The following year some students became upset after a lecture by a senior employee of Purdue Pharma with an adjunct appointment at Tufts (who had been giving occasional lectures on opioids for a decade). They complained that he was “sweeping the opioid crisis under the rug” and was “an apologist for the pharma industry” (Yurko and Remz 2019, 20).

There are also thousands of pages of emails, memoranda, and other contemporaneous documents—summarized in the complaint of the Attorney-General of Massachusetts made public in 2019—that reveal how Purdue Pharma’s relationships with academic institutions provided opportunities to influence research, curricula, speaker series, and other events. These opportunities were enhanced by the appointment of Purdue executives and employees to faculty and advisory boards, as well as by regular contact with these individuals (A.G. Mass. 2019). In addition, one recent estimate puts the total gifts from the Sackler family and its foundations to universities in the United States, the United Kingdom, and elsewhere in excess of $60 million during the last five years (AP 2019).2

In public health, corporate strategies of influence tend to involve public health NGOs, as well as academic institutions. And, perhaps unsurprisingly, the leadership of these institutions often overlaps. For example, one of the founders of the Tufts pain initiative also served as president of the American Academy of Pain Medicine (a medical professional association) and on the board of the American Chronic Pain Association (a patient advocacy organization) (Joseph 2019c). As a result, pharmaceutical companies could influence professional associations and advocacy groups without making additional financial contributions to those organizations. Nevertheless, opioid companies also targeted civil society groups, and gifts to these entities were a central component of several opioid companies’ strategies of influence.

Influencing Patient Advocacy Organizations, Professional Societies, and Other Civil Society Groups

Industry funding of patient advocacy organizations (PAOs), professional societies, and other health-related NGOs more broadly has become widespread (McCoy et al. 2017; Rose et al. 2017; Aaron and Siegel 2017). These organizations often face tight financial constraints and, not surprisingly, pharmaceutical companies are more than happy to “help out.” Although a corporate donation may be a drop in the ocean of business revenues and profits, the gift can be the main—or only—thing keeping the recipient afloat (Marks 2019a). The contributions of opioid companies to PAOs and health professional associations have been consistent with practices in the pharmaceutical sector more broadly. A U.S. Senate report revealed that five opioid manufacturers gave $9 million to fourteen patient advocacy organizations and health professional organizations over the five-year period 2012–2017 (HSGAC 2018a). Purdue and Insys were the largest donors by far, giving in excess of $4 million and $3 million respectively. While the U.S. Pain Foundation received more than any other organization—in excess of $2.9 million—several other groups were also dependent on funding from opioid companies. Notably, the Academy of Integrative Pain Management received more than $1 million and, when this funding dried up in the wake of the U.S. Senate report, the organization closed because it lacked sufficient funds to maintain operations (Anson 2019). The American Pain Society received almost $1 million from opioid companies, and it also dissolved in 2019 after facing lawsuits for its role in exacerbating the opioid crisis (McGreal 2019). It is notable that the organizations discussed in the report continued to accept opioid industry money after one of them, the American Pain Foundation, closed its doors in 2012 in the wake of an investigation revealing its dependence on opioid industry funding (Ornstein and Weber 2012).

Groups that received money from the opioid industry subsequently engaged in activities—including participation in policymaking processes—that protected and promoted the interests of their donors. As a result, some patient advocacy groups and health professional societies have been characterized as “front groups” for industry (e.g., Michaels 2020). But even when organizations are genuinely created to promote the interests of patients, they can be profoundly influenced by gifts from and relationships with corporate actors—as the ethnographic and behavioural science research on reciprocity makes clear. Reciprocity need not involve an explicit exchange (often called a quid pro quo); on the contrary, gifts can give rise to subtle reciprocity—which often manifests as a general disposition toward helping another (Marks 2019a). Companies understand and commonly exploit this to promote policies that protect their interests. A recent study concludes that corporations “strategically deploy charitable grants” to non-profit organizations so that the recipients will comment favourably in regulatory processes (Bertrand et al. 2018, 1). The authors also found that this strategy is effective at promoting regulatory discussions more closely aligned with the companies’ perspectives and commercial interests.

When the Centers for Disease Control and Prevention (the CDC) issued draft guidelines in 2016 recommending greater restraint in opioid prescribing, opposition was significantly higher among organizations that had received funding from the opioid industry (Lin et al. 2017). In addition, a number of groups that received opioid industry funding lobbied against legislation restricting opioid prescribing and produced their own guidelines downplaying the addiction risks (HSGAC 2018a). Recently released internal documents reveal that Purdue Pharma considered these kinds of guidelines to be “an effective tool for selling our products” (Ross 2019, ¶19). Influence on health-related NGOs is especially important because of the ways in which these bodies may, in turn, influence policymakers, policymaking, and the resulting policies.

A recent article in the BMJ expressed concern that the National Academies of Science, Engineering, and Medicine (NASEM)—an NGO established by federal statute with the express purpose of providing independent advice to the federal government in the United States—had received millions of dollars from several pharmaceutical companies (including opioid manufacturers), as well as gifts from members of the Sackler family (Schwab 2019). The article also expressed concern that members of NASEM panels, including one commissioned to advise policymakers on clinical practice guidelines for prescribing opioids, had received payments from opioid companies (in the form of research funding, consultancy fees, and advisory board retainers).

Representations from bodies that appear to be independent or—at the very least, that appear to be promoting the interests of patients—may be viewed with much less scepticism by public officials than representations coming directly from companies. But, once again, opioid companies left nothing to chance. Just as they made direct payments to PAOs and health professional associations to bolster indirect influence arising from relationships with leading health professionals, companies also reinforced indirect influence of public officials, legislators, and policymakers by making contributions to political campaigns and public health initiatives.

Influencing Public Health Officials, Legislators, and Policymakers

According to the Center for Public Integrity (CPI) and the Associated Press, between 2006 and 2015, opioid companies spent $880 million on lobbying and campaign contributions—dwarfing the $4 million spent by groups advocating limits on opioid prescribing, and (more surprisingly) exceeding by a factor of eight the gun lobby’s political spending (CPI 2016a2016b). The CPI found that the industry and its allies contributed to roughly 7,100 candidates for state-level offices, employing on average 1,350 lobbyists a year, covering all state capitals. Another study examined campaign contributions to members of the U.S. House and Senate committees charged with responsibility for leading the legislative branch’s response to the opioid crisis. It found that, during the two-year election cycle ending in November 2016, almost 90 per cent of the members of the House committee (forty-nine of fifty-five), and close to two-thirds of the members of the Senate committee (fifteen of twenty-three) had received money from political action committees (PACs) that were associated with firms under investigation by state and federal officials for exacerbating the opioid crisis (McCoy and Kanter 2018). Once again, while shocking, this was reasonably predictable. We should anticipate that opioid companies would try to influence legislators to the full extent that the law allows in their efforts to prevent legislators from undermining their commercial interests when responding to the opioid crisis. And we should also expect that these companies’ strategies of political influence would not be confined to lobbying and campaign contributions.

Another key element in the opioid companies’ strategies—consistent with corporate strategies in other sectors such as food and soda—is to engage in partnerships with government agencies. These are often termed “public–private partnerships” or, when academic institutions and public health NGOs participate too, “multistakeholder initiatives” (Marks 2019a). Sometimes, it is the corporate actors that initiate these relationships; at other times, the public bodies do so. In 2017, the National Institutes of Health (NIH) launched a “public–private initiative” to address the opioid crisis. More than one-third of the participants at its first two meetings in June 2017 were executives of drug companies, device manufacturers, or other industry actors (NIH 2019). They included representatives of Purdue Pharma and Johnson & Johnson—which, along with its subsidiary, Janssen Pharmaceuticals, was also a defendant in opioid litigation. Notably, when the NIH launched the partnership initiative, it made no mention of the role that its “private partners” played in creating or exacerbating the opioid crisis in the “special report” written by the directors of the NIH and the National Institute of Mental Health (NIMH) and published in the New England Journal of Medicine (Volkow and Collins 2017). On its website, the NIH director used the passive voice to avoid pointing the finger at drug companies: “The belief that people with pain would not become addicted to opioids was promoted 20 years ago in the medical community” (Collins 2017, ¶2). This statement begs the question: promoted by whom? It is not hard to see why Collins avoided that question. Self-censorship is common among the recipients of gifts and among public bodies participating in partnerships (Marks 2019a). The NIH clearly did not want to alienate the drug companies with which it wished to partner.

While the NIH considered Purdue Pharma a “partner,” the company wanted to make sure that the broader public did so too. It ran full-page advertisements in the New York Times (among others) that concluded with these words: “We want everyone engaged to know that you have a partner in Purdue Pharma. This is our fight too” (Purdue Pharma 2018, ¶5). At the same time, the company appears to have been engaged in a very different kind of battle—an internal debate about whether or not to continue disputing the claim that OxyContin can be addictive even when taken as directed. On July 19, 2018, Purdue ran another full-page “advocacy ad” in the Washington Post stating that the company was “acutely aware of the public health risks opioid analgesics can create, even when taken as prescribed” (Schulte 2018, ¶2, emphasis added). But less than a week later, when the company re-ran the advertisement, it deleted the words “even when taken as prescribed.” In addition, while the company was being described by the NIH as a “partner”—and while it was positioning itself as a partner—Purdue Pharma was also working on plans to expand the opioid market, including the market for therapies to treat opioid addiction resulting from the company’s own aggressive opioid marketing strategies (A.G. Mass. 2019).

To be clear, the efforts of the opioid industry to influence policymakers and prescribers were not limited to the United States. Investigative journalists have uncovered similar efforts to exploit international markets (Ryan, Girion, and Glover 2016; Kinetz 2019). And these efforts appear to have increased as opioid prescribing came under increasing scrutiny in the United States. Global promotion has been spearheaded by Mundipharma, a consortium of companies with offices in more than 120 countries. A recent congressional report produced by the offices of two U.S. representatives outlined the ways in which this consortium appears to have successfully influenced at least two WHO policy documents related to opioid prescribing—including 2012 guidelines that address pain management in children (Clark and Rogers 2019; WHO 20112012). In several ways, these guidelines (which were discontinued by the WHO in 2019 in the wake of the congressional report) were remarkably consistent with Purdue’s marketing strategies. For example, they embraced Purdue’s characterization of doctors’ concerns about prescribing opioids as “opiophobia.” The guidelines also stated that there is no maximum dose for opioids—even in the case of children. (Purdue Pharma and other opioid companies pushed broadly for higher doses, as they are significantly more lucrative than lower doses.) The congressional report also highlighted the role of patient advocacy organizations, professional associations, and industry-favourable articles published in their journals as avenues for indirect influence on the WHO (Clark and Rogers 2019).

Corporate Influence: Coordinated, Concurrent, and Competitive Action

Although Purdue Pharma has received considerable media attention in recent months for the aggressive marketing of opioids, it is important to keep in mind that several companies are alleged to have engaged in such practices. The picture that emerges is one of multiple corporations making gifts to and partnering with a variety of public health agencies, academic institutions, and health-related NGOs. These gifts and relationships were part of larger strategies that were intended to have, and did have, a number of interrelated effects—all of which served to increase the revenues and profits of the opioid companies. The strategies were designed to expand the base of patients who would be prescribed opioids from (often terminal) cancer patients to non-cancer patients experiencing either acute or chronic pain; to promote the acceptance of opioids as the drug of choice in such cases, despite the lack of evidence as to their efficacy (especially for chronic pain); to expedite the prescribing of opioids in place of other analgesics and pain therapies; to downplay the risks of addiction and abuse; to characterize doctors’ concerns about addiction and abuse as “opiophobia”; to promote the view that opioids are not addictive when taken as directed; and to blame patients when they became addicted.

The success of the opioid companies in these respects was the result of both independent and coordinated action. Corporations may influence policymakers through both kinds of activity, and trade associations often play a major role in coordinating action to influence policy in the pharmaceutical sector. PhRMA (Pharmaceutical Research and Manufacturers of America), the main trade association representing pharmaceutical companies in North America, has coordinated an industry response to the opioid crisis. As two New York Times journalists recently put it, “PhRMA is trying to position the industry on the right side of a health crisis that many blame it for creating” (Corkery and Thomas 2018, ¶10). The article in which that observation was made raised legitimate concerns about PhRMA providing funding to the patient advocacy organization, Addiction Policy Forum. Of course, the trade association’s support of this advocacy group is not an isolated relationship; it is part of the concerted strategy intended to influence the perceptions of policymakers, physicians, and patients (among others). Drug companies want us to see them as partners in developing solutions to the opioid crisis, rather than actors responsible for creating or exacerbating the crisis. Mirroring statements made by the NIH and the National Institute on Drug Abuse (NIDA), PhRMA issued its own press release announcing that it was “working to establish a public–private partnership” designed to “accelerate the development of innovative new treatments and therapies” (PhRMA 2017).

These are examples of what might be considered corporate coordination—collaborative efforts to influence policy and practice often mediated by a trade association. However, it is important to recognize that the independent actions of companies may also be highly influential, even when competitive. We saw above how five different opioid companies all made financial contributions to patient advocacy organizations and health professional associations related to pain management. To some extent, these activities might be regarded as concurrent—each company giving money with the intention of fostering an even more permissive attitude toward the use of opioids that would be reflected in the recipients’ representations to policymakers. But some of these activities might be considered competitive to the extent that the company making the donation intended to generate more prescriptions for its opioids by “stealing” potential patients from its competitors. Recent court filings in Massachusetts, for example, provide evidence of the competitive strategies of Purdue Pharma (see A.G. Mass. 2019). But whether concurrent or competitive, the effect of these contributions was the same: to influence the public statements and representations of civil society groups so that they too favoured the relaxation of prescribing guidelines and downplayed the addiction and abuse risks. Competitive and coordinated corporate strategies of influence may occur simultaneously as well as sequentially. As manufacturers of opioids and suppliers of active ingredients to other opioid companies (Hoffman 2019a), the Johnson & Johnson family of companies (which includes Janssen Pharmaceuticals) had an additional incentive to engage in both strategies. So, any counterstrategy intended to insulate governments, universities, and public health NGOs from corporate influence should also address both strategies.

The significance of these forms of influence becomes especially important when we consider the ethical challenges presented by public–private partnerships, which have become the dominant paradigm in public health. As I noted above, the NIH launched a “public–private initiative” in response to the opioid crisis, bringing together representatives of dozens of pharmaceutical companies. Policymakers often justify the practice of “engaging” with multiple competing corporations in a partnership initiative on the grounds that this ensures no single corporation receives preferential treatment. However, it is important to recognize the ways in which incorporating multiple powerful corporate actors from the same sector in a partnership can be ethically problematic. Bringing together multiple pharmaceutical companies can transform their concurrent actions into coordinated action—thereby magnifying the companies’ influence. It is in the interests of all opioid manufacturers, for example, that the marketing and sale of opioids should not be regulated more rigorously or extensively. It is also in the interests of all pharmaceutical companies, whether or not they are currently manufacturing or selling opioids, for public health agencies to focus on pharmaceutical responses to pain management and opioid addiction.

From Conflicts of Interest to a Norm of Separation

The traditional lens for understanding and addressing corporate influence in medicine and public health has been conflicts of interest. The definition of conflict of interest most frequently employed in this context is the one adopted by the Institute of Medicine (now the National Academy of Medicine) in the U.S.: “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest” (Lo and Field 2009, 46).3 But framing the problem of corporate influence as financial conflicts of interest tends to have two consequences. First, while conflicts of interest can be defined broadly to include institutional conflicts, attention is usually focused on individuals rather than institutions—for example, physicians who receive payments from drug companies, rather than academic medical centres or universities that might have equally problematic relationships with drug companies. Notably, a recent independent review commissioned by Tufts to explore the university’s relationships with Purdue Pharma and the Sackler family found that, while there were policies addressing individual conflicts of interest, the university did not have—and needs to establish—a comprehensive institutional conflicts of interest policy (Yurko and Remz 2019). Investigative journalism also tends to highlight individual physicians who have failed to disclose financial conflicts of interest arising from their relationships with corporate actors (e.g., Ornstein and Thomas 2018); less attention has been paid to institutional practices and cultures that might promote such behaviours. Conflicts of interest at the institutional level tend to be poorly managed, if they are managed at all, and rarely are they eliminated (Marks 2019a).

Once conflicts of interest have been recognized as a problem, the most commonly touted policy solution is disclosure of the conflict. The Physician Payments Sunshine Act (PPSA)—part of the Affordable Care Act—places the responsibility on drug and device manufacturers to disclose their payments to physicians and teaching hospitals (Richardson 2014). Section 6111 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act of 2018—entitled “Fighting the Opioid Crisis with Sunshine”—expands the scope of transactions covered by the PPSA to include payments to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anaesthetists, and certified nurse-midwives—commencing in 2022. Several scholars have also explored whether this requirement should be further extended to include payments made to patient advocacy organizations (e.g., McCoy 2018; Kanter 2018), and in October 2018, Senator McCaskill introduced a bill to this effect shortly before she lost her seat in the U.S. Senate.

Disclosure of financial conflicts of interest with corporate actors is necessary but not sufficient to address the systemic problem of corporate influence. It is the “ethical floor” as Bachynski and Goldberg (2018, 182) put it—the minimum, but far from all, that is required. Disclosure and other measures to promote transparency help reveal the extent of the problem of corporate influence. But we cannot and should not rely on such approaches to neutralize corporate influence. When policies primarily promote disclosure of conflicts instead of their elimination, there is a danger that they may exacerbate the problem of corporate influence—particularly when they lead policymakers and the relevant publics to believe (mistakenly) that problematic influence has been addressed. Several scholars have rightly expressed concern that disclosure, while necessary, might “crowd out” more effective measures to address corporate influence, including the elimination of relationships giving rise to financial conflicts of interest (e.g., Cain, Loewenstein, and Moore 2005; Loewenstein, Cain, and Sah 2012; Chambers 2017; Sah 2019; Marks 2019a; Kanter and Loewenstein 2019; Goldberg 2019; Marks 2020). This concern is especially acute in the case of the opioid crisis—fighting the crisis will require more than simply expanding the categories of recipient whose payments from opioid and other drug companies are subject to mandatory disclosure.

Given the evidence of the impact of interactions with drug reps on physicians’ opioid prescribing and on opioid-related deaths, there is a compelling case that the best way to protect patients and insulate physicians from such influence is to prohibit these interactions. Disclosure rather than elimination of these relationships places the burden of addressing this systemic problem on patients—individuals who are least equipped to tackle it and, worse still, are being harmed by it (see also Kanter and Loewenstein 2019). Notably, the vast majority of patients have not even begun to discharge that burden—they remain unaware of whether their doctors have received payments from drug companies, even though this information has been publicly available on the internet for several years (Kanter et al. 2019). But even if patients access this information—or if it is provided directly to them by their physician or the physician’s office (Rose et al. 2019)—we cannot assume they will understand why it matters. We should certainly not expect them to be familiar with the relevant social science—including scholarship exploring the limitations and potential adverse effects of disclosure (e.g., Cain, Loewenstein, and Moore 2005; Lowenstein, Sah, and Cain 2012; Sah 2019). Yet another burden on patients resulting from disclosure is what some scholars call “insinuation anxiety”—although patients may want to act on the disclosure, they may be afraid to signal distrust to their physician (Loewenstein, Cain, and Sah 2011; Sah 2016; Sah, Loewenstein, and Cain 2019). And, even if patients are willing to act, they may not have the time or resources to find another physician they trust. This is a great deal to ask of any patient, let alone one in severe pain.

Disclosure of the opioid industry’s relationships with universities, academic medical centres, and teaching hospitals, as well as individual researchers is also necessary, but not sufficient, if we are to address the influence of the opioid industry on medical research and education. We should bear in mind that many of the relationships were not a secret—for example, when Purdue Pharma gave a $3 million gift to Massachusetts General Hospital (MGH) in 2002, its centre was named the “MGH Purdue Pharma Pain Center.” Several meta-analyses have shown that industry funding of medical research tends to produce more favourable findings for the industry sponsor (see, e.g., Lundh et al. 2017; Bekelman, Li, and Gross 2003). Given that these analyses are based on studies that disclose their industry funding, it is clear that disclosure in this context does not serve to neutralize the bias.

In addition to the impact on research findings and the interpretations of those findings, industry-sponsored research influences the kinds of questions that researchers explore (and those they neglect or ignore) and the ways in which those questions are explored (Marks 2019a, 75–78). Research agenda distortion—which is not eliminated by the disclosure of the relationships that contribute to the distortion—can be both subtle and profound. In the case of the opioid crisis, it triggered an expansion of the use of opioids to non-cancer patients, and it continues to lead to an emphasis on pharmacological solutions to both pain management and addiction. I am not suggesting that pharmacological solutions have no place. But, if we are serious about solving these public health challenges, we must be prepared to explore all potential solutions, including those that may be inimical to the commercial interests of pharmaceutical companies.

It would certainly have been important for the CDC to know that many of the patient advocacy organizations and medical professional associations that were objecting to its draft guidelines (calling for more restraint on opioid prescribing) had received funding from opioid companies. This was significant information, whether or not the groups were dependent on industry funding (and some clearly were). Lack of dependence is not the same as independence.4 So the disclosure of patient advocacy groups’ and medical professional associations’ financial relationships is clearly necessary. But disclosure alone will not address the systemic problem that arises when, as is so often the case, most of the relevant public health NGOs related to a particular health problem receive funding from industry actors with a vested interest in the solution to that problem.5 Policymakers are then left with the unenviable task of having to decide whether to ignore these entities’ representations entirely or to accord them less weight—and, in either case, whether to do so across the board, or only when these groups’ representations align with the interests of powerful corporate actors operating in the same space. And, more fundamentally, policymakers lack what they really need—access to the full range of views and interests of patients that are truly independent of the views and interests of industry.

Turning now to public health agencies and legislators, once again we see that disclosure of financial relationships is necessary but not sufficient to address the problem of corporate influence. Some information on campaign contributions is already in the public domain. For example, the Federal Elections Commission in the United States maintains a database of campaign finance contributions from political action committees (PACs). (This database, available at https://www.fec.gov, is the one on which McCoy and Kanter 2018 relied to assess the industry ties of the House and Senate Committees charged with leading the response to the opioid crisis.) We do not know the full extent of campaign contributions by opioid companies because hundreds of millions of dollars in campaign contributions are made via “superPACs” that shroud the origin of the funds. Greater transparency in relation to “dark money” is clearly important, but campaign contributions and lobbying can still influence legislators even when they are disclosed—as congressional voting records make clear (see, e.g., the website of the Center for Responsive Politics, https://www.opensecrets.org). The solution, of course, would be to take corporate money—including opioid industry funds—out of politics (see, e.g., Lessig 2015). A detailed consideration of campaign finance reform is, of course, beyond the scope of this paper. But I will address another powerful vehicle for corporate influence: close relationships between public health agencies and opioid companies.

After the director of the NIH announced the “public–private initiative” to address the opioid epidemic (discussed above), he commissioned a working group to explore the ethical issues. The working group based its recommendations on concerns about “real or perceived conflicts of interest” (NIH Working Group 2018). The group stated that it was “preferable” that public funds be used from this initiative, but it only recommended a bar on industry funding where an opioid company was engaged in “litigation of concern” related to the opioid crisis. The advisory group recommended that, in other cases, money provided by industry actors should be “without conditions.” Even when companies are excluded from funding due to litigation, the working group said it would not only permit but encourage “in-kind” industry contributions to the partnership. In response to the group’s report, the director of the NIH said that he “fully embrace[d]” the recommendation that the NIH should address the crisis with government, not industry, funds (Collins 2018). He also said that any partnerships in this initiative would be “done with the utmost transparency.” These assurances, however, do not address all the ethical concerns.

First, influence can occur when there are no formal conditions (or “strings”) attached—in fact, reciprocity often makes such conditions entirely unnecessary. Second, reciprocal effects are not confined to cash payments; they may be triggered by the receipt—or mere anticipation of the receipt—of “in-kind contributions,” whether goods, services, or anything else of value (Marks 2019a). And third, transparent relationships may still be extremely influential. As I emphasized above, policymakers cannot and should not rely on transparency to eliminate corporate influence. In addition, such influence can distort policy agendas and reinforce the framing of two of our most pressing public health challenges, pain management and opioid addiction, in ways that are most likely to promote the commercial interests of the opioid industry and pharmaceutical companies more broadly (Marks 2019a, 78–81). This may explain the NIH’s emphasis on the development of new pharmaceuticals to address pain management and addiction (Collins 20172018).

It is tempting for public health officials to perceive an alignment of interests. At first glance, both the NIH and pharmaceutical companies might appear to have a shared interest in the development of effective non-addictive pain medications. But that apparent alignment warrants interrogation (Marks 2019a). Even when a corporation engages in a business activity with the express aim of promoting health, its primary objective is the generation of profits from the sale of goods or services. The primary obligation of public health agencies is to protect and promote public health. Divergence between these objectives is inevitable and, at times, acute. A drug formulated to promote health (for example, by alleviating pain) may turn out to be less effective than anticipated or to have dangerous side-effects. In such cases, public health agencies have an obligation to ensure, at the very least, that health professionals and patients are made aware of these concerns. However, the drug company will have a powerful economic incentive to exaggerate the benefits of the drug, downplay the adverse effects, and promote sales for as long as possible to protect revenues—especially when profits dwarf potential financial penalties. We have seen precisely this scenario play out in the opioid crisis, and policymakers should be at pains to avoid its repetition.

Partnering with the pharmaceutical industry to address the opioid crisis courts serious public health hazards. The threat to public trust in government, the academy, and civil society groups is now readily apparent, too (Rose 2013; Marks 2019a). But there is another important reason for public health bodies to be wary of close relationships with the pharmaceutical industry: institutional integrity. A key component of institutional integrity is consistency—in particular, consistency among what an institution does (its practices), what it says it does (its mission), and what it is obligated to do (its purpose) (Marks 20172019a). Public health agencies’ and NGOs’ relationships with the opioid industry have clearly served to undermine their public health mission and purpose—and, in turn, their integrity. The crisis is yet another painful reminder of the perils of partnership with any entity whose mission, purpose, or practices diverge fundamentally from those of one’s own institution (Marks 2019a).

What the opioid crisis has also made clear, moreover, is that looking solely at the ethical implications of a single relationship between a public health agency, university, or public health NGO on the one hand, and a private-sector entity on the other, fails to take into account the systemic problem arising from corporate strategies that involve (as they almost invariably do) webs of influence with a variety of institutions in government, the academy, and civil society. Corporations do not build individual relationships in isolation; they develop strategies to engage with all these actors. But when each of these actors considers the ethics of “engagement,” they tend only to focus on their own proposed relationship. Public health agencies, universities, and public health NGOs contemplating partnerships should be as attentive to webs of influence as the corporations that weave them.

Of course, being attentive to the webs of influence and their ethical and policy implications is resource intensive, and it cannot be a one-off enterprise either. Imagine you are the head of a public health agency. Yours may be the first public health agency to partner with corporation X. But that corporation may be using its partnership with you as a pilot or test case that it will then use to “sell” the idea of partnership to another public health agency. Your public health agency would need to continue to be attentive to the relationships that corporation X is weaving with other public health agencies, universities, and NGOs—in addition to other private-sector entities (including trade associations and consultancy firms) with whom the corporation is collaborating in order to exercise influence. And your agency would need to be attentive to these relationships throughout its own relationship with the corporation. Such constant (or, at least, periodic) vigilance would require considerable additional resources. But the full extent of the webs of relations may not be apparent until far too late—as in the case of the opioid crisis. The safer and far more advisable course of action is simply to avoid these relationships—to move from the corporate partnership paradigm to a new norm: separation, instead of collaboration.

Conclusion

For years, courts sealed documents that would have revealed the role of corporate strategies of influence in the opioid epidemic (Lesser et al. 2019). News outlets have been challenging this practice, and the courts are finally unsealing documents from earlier opioid cases (Ross 2019). There has also been a plethora of new litigation against not only opioid manufacturers but also opioid distributors—including several high-street pharmacy chains as well as commercial distributors. In addition to thousands of civil cases against opioid companies (Gluck, Hall, and Curfman 2018), a few individuals have faced criminal charges (Gonzales 2019). Several former executives of one opioid manufacturer, Insys, were convicted of fraud, and recently received prison sentences (Thomas 2020). The verdict was swiftly followed by the company’s agreement to pay $225 million to settle its own fraud charges (Thomas 2019). In Oklahoma, a judgment of $465 million was entered against the Johnson & Johnson companies for creating a “public nuisance” that resulted not only from the group’s promotion of its own brands of opioids but also from its promotion of opioids more generally and its supply of active ingredients to other opioid manufacturers (Hofman 2019a2019b). Purdue Pharma and Teva, which were also defendants in that case, settled shortly before the trial for $270 million and $85 million respectively (Silverman 2019). In order to avoid the landmark first federal trial, three commercial distributors and one manufacturer (again, Teva) also agreed in October 2019 to pay two Ohio counties $260 million (Hofman 2019c). And in February 2020, Mallinckrodt Pharmaceuticals, the largest opioid manufacturer in the United States, announced a tentative agreement to pay $1.6 billion to settle lawsuits brought by state and local governments for its role in the opioid crisis (Kaplan and Hoffman 2020).

Amid discussions of further settlements, two thousand cases wait in the wings (Hoffman 2020b). But we should not expect these cases and settlements to make good the economic losses resulting from the opioid epidemic (Hoffman 2019d2020a). Purdue Pharma and Insys have already filed for bankruptcy (Hals 2019a2019b). The judgement against Johnson & Johnson will only cover one year of one state’s abatement costs for an epidemic that will take decades to address. If efforts to reach a larger coordinated settlement are successful, they would be measured in the billions of dollars—far short of the trillions of dollars in the most recent cost estimates (Hoffman 2019c; CEA 2019). And any settlement would, of course, not bring back the hundreds of thousands of Americans who have died, nor would it restore the lives of the families and communities destroyed by the epidemic. If we are to prevent future loss of life, we need to supplement “backward-looking” strategies based on establishing legal liability with some forward-looking ones (Young 2011; Marks 2017). Such forward-looking strategies must address the webs of relationships that served as vehicles for corporate influence and severely exacerbated the current crisis.

If the opioid epidemic has taught us anything, it is that governments, intergovernmental organizations, the academy, and public health NGOs need to be pre-emptive and proactive, developing comprehensive counterstrategies to insulate themselves from corporate influence. Whatever metaphor we use to describe corporate strategies—whether we characterize them as “webs” (Freudenberg 2014; Gornall 2015; Marks 2019a) or “tentacular” (Joseph 2019c)—the implications are the same: in order for counterstrategies to be effective, they cannot address individual relationships with industry actors in isolation. The opioid epidemic makes clear that individual institutions—whether governments, universities, or public health NGOs—are unlikely to be fully aware of the networks of relationships in which they are implicated until many years later. By that time, the damage may already have been done—as was undoubtedly the case with the opioid crisis. If we are to protect and promote public health, we will need a paradigm shift.

In order to bring about such a shift, we must first recognize that medicine and public health were not always so heavily dependent on corporate funding. The influx of this funding has burgeoned in the last few decades, as corporations increasingly and understandably recognized the opportunities for the promotion of their commercial interests that this affords them. But the relationships with industry that are now the norm were once frowned upon. This may not be readily apparent to the current generation of policymakers, researchers, practitioners, and others in medicine and public health—it may seem as though things have always been this way. But we need only turn to the work of the late Arnold Relman, former editor of the New England Journal of Medicine, in the early 1980s to be reminded that this is not the case. Drawing on President Eisenhower’s warning about the “military-industrial complex,” Relman expressed concern about the “new medical-industrial complex,” and cautioned that relationships with drug and device manufacturers had become “more pervasive, complex, and problematic” (Relman 1980, 963; Relman 1984, 1182).

Despite Relman’s warnings, that trajectory has only increased during the last four decades. But it is not too late to change direction. Changing direction will require more than the withdrawal of donors’ naming rights in response to criminal convictions, public outrage, or opprobrium (Barry 2019; McNeil 2019). First, public officials, academic administrators, and the leaders of public health NGOs must recognize that corporate influence in public health is a systemic problem, and they must speak out about that problem. If it is difficult for individual public officials or academic administrators to speak out on their own, they can collaborate with others by making a joint statement—for example, an open letter to the New York Times that makes clear why corporate partnerships are problematic and why more public funding to protect and promote public health is necessary. Government agencies may also collaborate with each other, instead of collaborating with industry, to address public health problems (Marks 2019a). Notably, the opioid litigation has involved considerable collaboration among states’ attorneys-general. Working together, public health agencies can not only collaborate on addressing individual public health challenges, they can also develop strategies to wean themselves from industry funding. The same may be said for the academy and public health NGOs—including health professional associations (which have the power to influence norms and expectations for other institutions, as well as individual professionals). Although these institutions may not be able to restructure their funding strategies overnight, it is not unrealistic to expect them to develop a five- or ten-year plan.

Many proponents of corporate partnerships argue that we cannot afford to tackle the major challenges in public health without industry funding. But the opioid epidemic was fuelled by these very relationships, and it has cost us trillions of dollars. Given the human and financial toll, we simply cannot afford to carry on doing “business as usual” in public health.

What would you like to know about your physicians potential conflicts of interest regarding your care? What should the relationship be between the pharmaceutical industry and doctors with regard to paying them indirectly to prescribe drugs to their patients: like you? How can conflicts of interest among your doctors impact your health?

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Acknowledgments

The author is extremely grateful to Michele Mekel and to all the student and faculty participants in the Penn State Bioethics Colloquium for their invaluable feedback on an earlier draft. This article also benefited from the author’s discussions with several colleagues at other institutions—among them, Marc Rodwin, Sunita Sah, Genny Pham Kanter, Susannah Rose, and Lisa Cosgrove. He is also grateful to Quinn Grundy and another (anonymous) reviewer for their extremely helpful comments and suggestions. Please excuse any errors and omissions—final revisions to this piece were made during the COVID-19 pandemic.

Footnotes

1The Sackler family’s arts philanthropy has attracted much attention. I focus my analysis here on relationships with entities in health and policy spheres because they appear to have most directly contributed to the opioid crisis. But I recognize that arts philanthropy also merits ethical scrutiny that I cannot provide in the space permitted.

2Although university gifts made by Purdue Pharma and the Sackler family have attracted the most public scrutiny, the conviction of the former CEO of Insys, John Kapoor, drew attention to his gifts to the University of Buffalo’s School of Pharmacy and ultimately led to the removal of his name from the school’s building (McNeil 2019).

3For a thoughtful critique of this definition, see Rodwin 2018. Rodwin argues that the Institute of Medicine’s 2009 definition of conflicts of interest “neglects the actor’s compromised loyalty to the party or mission she is supposed to serve” (70) and that, by referring to conflicts between primary and secondary interests rather than conflicts between obligations and interests, this definition “diminishes the conflict’s significance” (70). Rodwin also expresses concern that “[e]fforts to include so-called intellectual or nonfinancial conflicts as conflicts of interest blur the concept” (75).

4Physicians are not dependent on drug companies for pens and mugs—they can afford to buy their own! But these small gifts influence them nonetheless. See, e.g., Sah and Fugh-Berman 2013; Lo and Grady 2017.

5Although widely publicized investigations revealing opioid company payments to PAOs and health professional associations led to withdrawals of funding and, in a few cases, to the recipient organizations ceasing to operate, industry funding of patient advocacy groups remains pervasive. One recent study found that 83 per cent of the 104 largest groups received funding from drug, device, or biotechnology companies (McCoy et al. 2017). We should not expect disclosure alone to lead to the widespread elimination of these relationships, especially if the pervasiveness of these relationships reinforces the (problematic) view that they are acceptable or unavoidable.

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

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Opioids Crisis & Kids

Protecting Teens from Rx Opioids: Ask, Manage, Talk

Shidonna Raven Garden and Cook
Source: Mass Gov
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What medications do your children take? Why? How do you protect them from addiction?

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