(Bloomberg) -- Grim-faced sheriffs peered from Washington D.C.-area television screens in hundreds of ads this summer, imploring the country’s leaders to reject proposals to import cheaper prescription drugs from other countries.

Importing drugs would “put lives I’m sworn to protect at risk,” Kentucky Sheriff Keith Cain declared from beneath the brim of a white cowboy hat in one of the spots. It, like the others, warned that deadly counterfeit medicines would slip through loose foreign safeguards and overwhelm law-enforcement agencies. The ads concluded by telling viewers they were paid for by the National Sheriffs’ Association, which represents 3,000-plus U.S. sheriffs.

In reality, the ad blitz was secretly paid for by at least $900,000 in grants from the Partnership for Safe Medicines, a nonprofit that’s been funded and operated by the pharmaceutical industry’s trade association. It was a lucrative arrangement for the financially strapped sheriffs’ group, which had been rejected by six banks last year as it sought to refinance its real estate assets to pay overdue bills, according to its internal records. The organization pocketed proceeds of at least $125,000, according to internal emails obtained through more than a dozen public records requests.

The commercials are just one part of a two-year campaign that used secret payments, a widely  criticized consultant’s report and even celebrity drug cops to concoct public-safety arguments against drug importation and then use them to foster the appearance of widespread concern among law-enforcement groups.

Those arguments have been roundly discredited—if not hooted at—by various experts, who say they ignore various safety protocols in both the U.S. and Canada. Still, the effort and expense that the pharma-backed nonprofit put into funding the campaign reflects the industry’s devotion to preserving the U.S. market, where consumers often pay twice as much for prescription drugs as counterparts abroad and give pharmaceutical companies their single largest source of profit. As Congress and the White House debate proposals to limit spiraling drug prices— including unleashing the federal government’s clout to negotiate with drugmakers or tying U.S. prices to those charged in other countries—the industry’s behind-the-scenes battle against drug importation shows how formidable a force it can be.  

 

Holly Campbell, a spokeswoman for the pharmaceutical-industry’s main trade group, didn’t respond to specific questions for this story. In a written statement, she confirmed that her group, Pharmaceutical Research and Manufacturers of America, or PhRMA, gives money to the Partnership for Safe Medicines, the group that gave the sheriffs’ association the grant. PhRMA, which had a 2017 budget of $456 million, donates to the much smaller nonprofit to support the fight against drug-importation plans, Campbell said. She called such plans “far too dangerous for American patients.” A spokesman for the sheriffs’ association declined to comment.

The drug industry’s campaign is all the more remarkable when you consider that it’s aimed at defeating importation proposals that probably wouldn’t significantly alter the U.S. market, anyway. Already, about half the drugs consumed in the U.S. are made overseas, but only pharmaceutical manufacturers are allowed to import them for distribution in the U.S. Under federal law, wholesalers or pharmacies that want to import cheaper drugs may do so from only one country—Canada—and only with the approval of the federal government. So far, no approvals have been granted.

It’s by no means clear that allowing the importation of drugs from Canada would help U.S. consumers save. Economists doubt that drugmakers would send Canada—which has a population one-ninth that of the U.S.—enough supply for significant amounts to then make their way into America’s medicine cabinets.

“It’s pretty much political theater,” said Peter Bach, director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes. Nonetheless, importation proposals offer “a gateway to a larger conversation about drug pricing which the industry would rather not have,” he said.

Steering the debate toward public-safety concerns is one way to put off that conversation.

 

In 2003, Congress approved a law allowing for drug importation from Canada, as long as the federal government certifies that the imported drugs will “result in a significant reduction in cost” and there’ll be “no additional risk to the public’s health and safety.” That same year, a new nonprofit was created to keep an eye on the public’s health and safety: the Partnership for Safe Medicines.

Headquartered in a San Francisco high-rise, the nonprofit has had deep ties to PhRMA for most of its existence. From 2005 to 2017, it was run by executives who simultaneously worked for PhRMA. And in its tax filing for 2017, the smaller group listed Shannon Monsif, PhRMA’s vice president of advocacy and strategic alliances, as its “principal officer” and treasurer. (PhRMA’s Campbell called that listing a mistake. “Due to an error, Shannon’s name was mistakenly listed,” she said in a statement. “Shannon has never been an officer of the organization.”)

Four former employees and consultants who worked with PhRMA and the Partnership for Safe Medicines say the industry group largely ran the nonprofit. For example, Justin Kenderes worked for the partnership as a consultant from 2007 to 2016, and for the first several years, he says, his paychecks came directly from PhRMA. (Kenderes says importation plans are a poor solution for rising drug costs, but he believes PhRMA should be more transparent about how it’s trying to influence the debate.)

For most of its life, the PhRMA-backed nonprofit focused on raising awareness about counterfeit prescription drugs and fly-by-night online pharmacies. That changed after the 2016 election, when both candidates, Donald Trump and Hillary Clinton, expressed support for importing cheaper medicines from foreign markets as a means of cutting drug prices.

In 2017, the nonprofit’s annual budget jumped twentyfold, to $7.3 million. The group says it’s entirely funded by dues from its 49 member organizations, including PhRMA, but it doesn’t disclose how much each member pays. Its executive director, Shabbir J. Safdar, declined to comment.

It’s hard to determine exactly how much PhRMA contributed to that dramatic 2017 cash infusion—but this much is clear: Many of the nonprofit’s other member groups pay no dues at all. Fourteen of the group’s non-PhRMA members shared detailed information about their payments, all of which were either $0 or $100 in 2017. For example, the National Association of Chain Drug Stores, which had a budget of $44 million in 2017, said it paid just $100 to be a member of the Partnership for Safe Medicines that year.

The new cash arrived just as Trump took office, vowing to reel in drug prices. So far, the president has faced resistance on some initiatives from his fellow Republicans, and a nascent impeachment inquiry in the Democrat-controlled House will almost certainly chill any bipartisan approaches. That’s one reason why Canadian drug-importation proposals seem at least somewhat viable: They’re being debated—and often approved—by state lawmakers, bypassing Washington’s gridlock.

In the past year, at least 16 states proposed plans to import drugs from Canada. Governors in Colorado, Florida, Maine and Vermont have signed plans into law. The state programs must still be approved by federal regulators, which could take more than a year. On July 31, the Trump administration vowed to work with states to accomplish that aim.

Meanwhile, the Partnership for Safe Medicines has spent its expanded budget in ways that resemble Big Pharma’s traditional playbook: It relies on allies with top-notch reputations. In some cases, it has given money to groups like the sheriffs’ organization, which then put their own names on anti-importation ads. Meanwhile, public-relations firms with ties to the PhRMA-backed nonprofit have ghost-written articles about the issue, recruited law-enforcement officers to sign their names to them and then pitched them to newspapers around the country.

“In Washington, everyone wants to cloak themselves in the mantle of public interest,” said Robin Feldman, a professor at the University of California Hastings College of the Law in San Francisco and the author of a book about soaring drug prices. “The pharma industry is very, very good at doing this.”

It began with a payment to a former director of the Federal Bureau of Investigation.

In 2017, the Partnership for Safe Medicines hired former FBI Director Louis Freeh’s consulting firm to prepare a report on how drug-importation proposals would affect law enforcement’s ability to protect public health. The nonprofit paid Freeh’s firm at least $322,000 that year, records show. Freeh’s 47-page report concluded that the plans would open “a new, unregulated pipeline into the United States” and could “create opportunities for criminal organizations to profit.” It cited a handful of case studies in which online pharmacies, such as CanadaDrugs.com, sold misbranded drugs into the U.S.

But none of the state drug-importation plans that are being proposed or developed in the U.S. seek to allow imports from unregulated online pharmacies. Any pipelines the plans might open would indeed be regulated—in both Canada and the U.S.

 

“The safety arguments are, quite frankly, ridiculous,” said Michael Law, an associate professor in the school of population and public health at the University of British Columbia. “People aren't dying in the streets of Canada from unsafe medications.”

Freeh and two other executives at his consulting firm, Freeh Group International Solutions LLC, didn’t respond to a half-dozen emails and phone messages seeking comment.

Freeh’s report became a foundational text for opponents of importation, who have cited it scores of times in op-eds, testimony and television ads. Consider this sequence: Freeh released the report in June 2017. That same month, the National Sheriffs’ Association issued a resolution that criticized drug-importation proposals. It said the plans would open the U.S. drug supply to counterfeit medicines, and it provided a single citation to back that claim—the Freeh report.

The next month, internal emails show, the sheriffs’ group received a $10,000 grant from the Partnership for Safe Medicines. Also in July, the National Association of Drug Diversion Investigators (Naddi) began running a series of ads in Washington-area newspapers that showed an officer talking into a police radio. “Every day, America’s law enforcement officers fulfill their solemn oath to protect our communities and serve our citizens,” it said. “However, their job becomes much harder if Congress passes laws allowing importation of medications.” The ad cited the Freeh report.

That same year, Naddi, which trains law enforcement officers, received a $77,500 payment from the Partnership for Safe Medicines. Naddi executive director Charlie Cichon didn’t respond to numerous emails and phone messages asking about the ads and the payment.

For the sheriffs’ group, 2017 was just the beginning.

In recent years, the National Sheriffs’ Association (NSA) has struggled with its finances. In 2018, it sold $1.8 million in investments to pay off debt and overdue staff salaries, internal documents show. It turned, with increasing success, to trying to win grants from corporations and other nonprofits, such as the Partnership for Safe Medicines.

By 2019, the PhRMA-backed nonprofit had become the sheriffs’ biggest grant-provider. An internal financial document from April shows that the partnership had provided $908,926 to the sheriffs’ group in the previous six months—almost half the $1.9 million in grants that the law-enforcement group received in that period.

In a June email exchange, a leader of the sheriffs’ group told a member that the ad campaign against drug importation was an important moneymaker that would be used to pay staff salaries and operational expenses. “NSA has received a grant from the Partnership for Safe Medicines for this NSA initiative that covers ALL the ad buys and that earns NSA $125,000 over about the next 3 months,” wrote Tim Woods, the group’s deputy executive director.

Woods and Jonathan Thompson, the executive director of the sheriffs’ group, didn’t respond to emails and phone calls seeking comment; Patrick Royal, a spokesman, declined to comment.

It’s not clear how many members of the sheriffs’ organization knew it was receiving money from a group backed by the pharmaceutical industry. Keith Cain, the Kentucky sheriff from rural Daviess County who starred in one of this summer’s TV ads, says he initially wasn’t aware of the ties between the partnership and Big Pharma. “I’ve certainly become aware of it since,” he said. “Is that a concern? Sure, it’s a concern.” Nonetheless, he insists that drug imports are a bad idea and says the grant money didn’t influence the sheriffs’ group’s position.

Sheriff Justin Smith of Larimer County, Colorado, has also opposed drug imports—with an assist from the Partnership for Safe Medicines. Smith signed his name to an op-ed in The Coloradoan newspaper in March that criticized drug importation, and he signed testimony opposing a Colorado importation proposal for state lawmakers in April.

Drafts of both the op-ed and the testimony were supplied to Smith by Sven Bergmann, a consultant working with the nonprofit, internal emails show. “We tried to capture your points and they flowed nicely into the piece,” Bergmann wrote in an email to Smith. Bergmann didn’t respond to emails and phone messages seeking comment.

Reached by phone, Sheriff Smith railed against the idea of allowing people to buy drugs from Canadian websites—even though Colorado’s importation proposal would not allow that.

“These are websites that say they’re from Canada, but they can be from anywhere,” he said. When told that isn’t how the proposed system would work, he said he checked with the narcotics people in his department, who told him drug imports would be a problem. Asked if he was aware of who funds the partnership, he said he’s not sure, but he assumes that it had gotten some funding from the drug industry.

“I take nobody’s word for it,” he said. “I check everything out independently.”

Two lawmen who inspired television characters are also working with the Partnership for Safe Medicines. In April, the nonprofit ran TV ads in Florida declaring that “state senators are pushing a new government program that allows prescription drugs from China without FDA inspection.”

That wasn’t true; Florida’s legislation called for importing drugs from Canada, not China—and the drugs would still have to meet the Food and Drug Administration’s standards. Regardless, the partnership followed up the commercials with robocalls that invited people to join a conference call with former Drug Enforcement Administration agents Javier Pena and Steve Murphy. The pair’s work to help take down Colombian drug kingpin Pablo Escobar was dramatized in the hit Netflix series “Narcos.”

“They’re holding a briefing right now to warn Floridians about the dangers of a new government program your state senator is pushing in Tallahassee,” the robocall said. “It would legalize importing prescription drugs from China, which has a long history of producing counterfeit medications and has been flooding Florida communities with illegal fentanyl.”

It was “a good, old-fashioned scare campaign,” said Tom Leek, a Republican state representative from Ormond Beach, Florida, who introduced the drug-importation bill, which eventually passed this year. “Their real fear is that this could have a significant impact on the profit margins of drug companies.”

Murphy and Pena, who are marketing themselves for speaking events and are publishing a book this year about their hunt for Escobar, have also appeared at a pair of congressional briefings that the Partnership for Safe Medicines sponsored. They didn’t respond to several questions about such efforts or whether the nonprofit has compensated them.

One retired cop who was recruited into the anti-importation effort says he feels bitter about the experience.

Shortly after Tim Hampton retired as a commander from the Phoenix police department in 2017, he says he got a call from Sven Bergmann, the Partnership for Safe Medicines’ consultant. They discussed the opioid epidemic, particularly how the synthetic painkiller fentanyl has harmed countless U.S. communities. (“We saw it nonstop, it was everywhere,” Hampton recalled. “People were dropping like flies.”)

Eventually, Hampton says, Bergmann sent him a ghost-written article and asked if he’d put his name on it. The article was mostly about the fentanyl crisis, but it took some jabs at drug-importation proposals. It cited the Freeh report and suggested that nationwide drug importation “could flood the Grand Canyon State” with fentanyl. Hampton didn’t know much about drug importation, but took Bergmann’s word for it. Now, he said, he realizes that Bergmann lured him in with the fentanyl issue. “That’s where they put the hook in.”

Hampton agreed to put his name on the article, and it ran in a number of small Arizona newspapers that touted his law enforcement credentials. One headline blared: “Fentanyl is killing Arizonans, is Congress OK with that?”

Now, Hampton said, he knows that importing drugs through FDA-approved pathways won’t lead to a new scourge of fentanyl. And he thinks Bergmann was working not for public safety, but the pharmaceutical industry.

“I should have done some more homework,” Hampton said. “You can’t trust these guys in the pharma industry as far as you can throw them.”

 

 

To contact the author of this story: Ben Elgin in San Francisco at belgin@bloomberg.net

To contact the editor responsible for this story: John Voskuhl at jvoskuhl@bloomberg.net, Flynn McRoberts

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