The twice-a-day medicine was a breakthrough because it supplanted an existing drug with debilitating side effects that had to be taken every six hours around the clock 鈥� a missed dose could permanently damage a child’s kidneys.

But the families’ elation dimmed when Raptor Pharmaceutical, which acquired the marketing rights and financed clinical trials for Procysbi, priced the drug: more than $300,000 a year for some patients.

“When I heard the number, I was like, holy 鈥� that’s incredible!” said Kevin Partington, the father of twins with cystinosis. “The first thought was, how do we pay for it and get this approved through insurance?”

Manufacturers selling precious, lifesaving medicines and patients share an uneasy alliance. They need each other but have clashing priorities, especially when it comes to drugs treating rare diseases such as cystinosis.

Cystinosis families say they are deeply grateful for Procysbi. The medicine would not be on the market without Raptor 鈥� which performed clinical trials 鈥� and Horizon Pharma, which acquired the rights two years ago, they acknowledge.

But they also feel they’ve been used. What began as a desperate search for life-extending medicine, cystinosis parents say, has become a story of corporations profiteering off their children.

What’s more, they say, even as they have tried to keep the companies at arm’s length, Horizon and Raptor have breached sensitive boundaries around their tightknit community to increase sales.

“I feel like it’s all about the bottom line,” said Denice Flerchinger, who has a daughter with cystinosis and helped raised some of the first research funds for the drug. “I don’t think any of us thought they could do this and get away with it.”

Procysbi is an “orphan drug,” under FDA rules, giving its makers an extended monopoly and the opportunity for big profits because it treats a disease affecting only about 500 Americans.

Its price has risen five times in the past five years, first by Raptor and later through its current owner, Horizon. For some patients, it now costs more than $1 million annually.

Procysbi’s high cost is needed to finance research for a range of medicines, said Matt Flesch, a spokesman for Horizon, which bought Raptor in late 2016 and has raised the drug’s list price 21 percent since then, according to data from Connecture, an information-technology firm. “If rare diseases don’t have a higher price, then companies aren’t going to bring new medicines forward,” he said.

After rebates and discounts, Horizon’s average annual revenue per patient is about $486,000, Flesch said. No patient needing Procysbi lacks it, due to a Horizon program that covers deductibles and copays or the entire cost if insurance is lacking, he added.

Cystinosis is an inherited disease that keeps children from processing a protein component called cystine, slowly weakening organs and tissues. Without treatment, patients can go blind and develop end-stage renal disease by their 10th birthday.

Treatment can be brutal. Before Procysbi, the only medicine prolonging life 鈥� typically into a patient’s 20s, when a kidney transplant is often needed 鈥� tasted like sulfur, induced vomiting, made an embarrassing odor and had to be taken every six hours. Even one missed 3 a.m. dose meant rising cystine levels for a baby or toddler and the possibility of permanent organ damage.

In 2003, Nancy Stack’s daughter Natalie made a wish on a napkin in purple crayon on her 12th birthday: “To make my disease go away forever.”

Years ago, “you were handed a pamphlet, 鈥榃hen Your Child Has a Terminal Illness,’ dot, dot, dot,” Stack said. “It never sat well with us. But when our own daughter at 12 understood that if there was no cure it meant she was doing to die, then we realized, wow, this is a big life event for us.”

Through friends, relatives and her husband’s contacts in real estate, the Stacks raised money for research and founded a nonprofit now called the Cystinosis Research Foundation. At the same time, they began building a network of families who were coping with a frightful illness.

“It was so encouraging to see this community doing all these amazing things,” said Nicole Manz, who learned about CRF in a hospital room where doctors diagnosed her son with cystinosis. “It was really empowering for our family.”

CRF’s ultimate goal was a cure, but one early, promising idea was to make the existing treatment easier to take. Scientists at the University of California-San Diego, a longtime center of cystinosis research, theorized that a time-release coating on the medicine could reduce side effects and the need for frequent doses.

With multiple CRF grants totaling $1.6 million funding early investigation, researchers found their hypothesis was correct. Now the foundation needed a corporate partner to finance more trials required for FDA approval.

Raptor, a company with about a dozen employees and no revenue, had acquired the rights to what would become Procysbi in 2007 and agreed to finance clinical trials to get it to market.

Raptor executives were quick to acknowledge how much they relied on the foundation and UC-San Diego, not only for the preliminary research but also for the patients’ contact information, which would save millions in marketing costs.

“We’re kind of coming in at the eleventh hour” in developing Procysbi, Raptor’s then-CEO, Christopher Starr, told the San Francisco Business Times in 2012, shortly before the drug’s launch.

Raptor’s research-and-development expense leading to Procysbi’s launch in June 2013 came to about $80 million, financial statements show. Most of that went toward getting Procysbi approved for cystinosis, although some was spent on investigating other drugs or diseases.

As Procysbi moved closer to approval, families knew it would be expensive. That’s not unusual for a rare-disease drug with a small market. Cystagon, the older, non-coated version of the medicine, cost about $9,000 a year at the time.

But nothing prepared those families for what happened. The $300,000 launch price was so high that Raptor CEO Starr objected, said Dr. Patrice Rioux, who was the company’s chief medical officer and also opposed the pricing.

Starr “was a scientist who wanted to provide the drug at a relatively good price,” Rioux said in an interview. “The board was not of this opinion” and overruled him, he said.

Starr did not respond to requests for an interview. In 2014, a year after Procysbi’s approval, the company announced his resignation as CEO, although he stayed on Raptor’s board. Rioux said he resigned at the same time.

“At the time of Procysbi’s approval, there was full agreement about its price within management,” Julie Anne Smith, who replaced Starr as CEO, said in an email. “I am proud to have been part of the Raptor team who worked with the cystinosis community” to get the drug approved, she said.

Stack wrote an angry note shortly after learning about the price.

“I feel awful about all this and personally accountable,” she said in an email to Raptor executives. “It is so disheartening 鈥� the community will suffer from the high cost of Procysbi.”

The drug quickly brought in far more money than Raptor spent developing it, a result of its acceptance by patients and insurers, plus the steep price increases.

Procysbi’s list price is 48 percent higher than it was in 2013. The drug has generated revenue totaling about $500 million through June 2018 for both Raptor and Horizon, financial statements show. At the time of the Horizon buyout, Raptor revenue of $1.5 billion from 2019 through 2026.

That cash stream prompted Horizon to buy Raptor for $800 million in 2016, enriching Starr, who still held shares and options worth $8.7 million, and Smith, his replacement CEO, who got $7.5 million in merger-related payments, according to an analysis of regulatory filings by Andy Restaino, CEO of Technical Compensation Advisors, an executive pay consultancy.

UC-San Diego, which licensed the rights to market Procysbi, has collected $20.9 million in royalties from Horizon and Raptor through 2017, according to data obtained under public information laws. The university “does not play a role in setting the market price for any drug,” UCSD said via a spokesman. Royalties help finance new research, it said.

Meanwhile the nonprofit organization started by families to develop the medicine, which held no business rights, got nothing.

“Those early grants were just [a] letter form and a handshake with the doctors,” Stack said. “We really didn’t understand how complex the system is, and how universities typically own all the 鈥� rights. We didn’t see dollar signs in our children.”

Procysbi proceeds have financed new research including continuing cystinosis studies as well as potential drugs for thyroid eye disease, rheumatological illness and other ailments, said Horizon spokesman Flesch. Last year, Horizon spent $225 million on research and development, according to financial statements.

“We’re really transforming ourselves into a research-focused company, and a primary focus there is orphan diseases,” Flesch said.

About three-fourths of U.S. cystinosis patients now take Procysbi, but Horizon continues to work aggressively to .

The company’s strategy for growth relies on building tight relationships with patients and advocacy groups, a typical marketing approach for companies selling orphan drugs, said Annabel Samimy, who follows pharma stocks for Stifel Financial.

But for some, the personal touch is intrusive. CRF had to ban Raptor reps from emotional family meetings that broached topics such as bed-wetting, Stack said. Tearful Raptor employees once joined patients in making posters about cystinosis hopes and fears, which seemed inappropriate, she said.

Horizon pays for travel and lodging to where intense discussions among patients and families can feel like therapy. The company makes audio recordings of the sessions to use in market research, which some patients find deceptive, said Shannon Keizer, a cystinosis patient in her 20s.

The company also hosts where families speak to physicians and one of eight Horizon “ambassadors” 鈥� patients and their family members who receive a $500 honorarium for each event

“Instead of wining and dining and paying out stipends, they need to lower the price of the drug,” said Flerchinger. “It’s our money they’re spending.”

Horizon’s Facebook page, branded as “Cystinosis United,” resembles the private Facebook groups where cystinosis families console and encourage one another, with pictures of smiling patients and slick, touching videos. The company added its logo to the banner photo after parents complained, according to a company email.

In conversations with Horizon, Stack refers to this hands-on approach as “overreach.” But she said she lies awake at night worried that her outspoken criticism could cut off access to her daughter’s life-sustaining drug. Horizon could stop manufacturing it.

“I think that’s the risk of doing all this. Speaking out so forcefully about the drug price,” Stack said. “What if they say this is really a pain so we’re just going to drop this drug? I would never forgive myself, because we discovered” it.

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The New York Republican sat on Innate’s board and had invested millions in the company. His son owned Innate shares. So did numerous friends as well as Tom Price, a fellow congressman who became secretary of Health and Human Services in 2017.

“I talk about it all the time,” Collins once said of Innate to CNN.

He talked one time too many, according to federal prosecutors who on Wednesday charged him and two others with violating insider trading laws.

Collins leaked sensitive information about a failed clinical trial last year that quickly reached seven people who were able to dump Innate shares before the bad news got out, according to filed Wednesday in U.S. District Court for the Southern District of New York.

“Congressman Collins had a legal obligation to keep that information secret until made available to the public,” said Geoffrey Berman, U.S. attorney for the district. “Instead, he decided to commit a crime. He placed his family and friends above the public good.”

Collins, who pleaded not guilty, will “mount a vigorous defense to clear his good name,” his lawyers said in a prepared statement, noting that he didn’t sell any of his own Innate shares.

The indictment may be the first time a sitting member of Congress has been prosecuted for allegedly tipping inside stock information to others, ethics experts said.

“I’m not familiar with another instance,” said Donna Nagy, an Indiana University law professor and congressional ethics authority.

House Speaker Paul Ryan removed Collins from the powerful Energy and Commerce Committee on Wednesday and called for a new investigation by the House Ethics Committee. Last year, the at evidence that Collins had previously “shared material, nonpublic information” on Innate.

Innate’s stock plunged to nearly zero in June 2017 after the company disclosed that its leading drug, intended to treat multiple sclerosis, had failed a key clinical test.

The news erased millions of dollars in wealth for Collins and many in his hometown of Buffalo and elsewhere whom he had recruited as investors. Innate shareholders included Buffalo business people, doctors, lobbyists and donors to his campaigns, Kaiser Health News .

A Politico Collins bragging on the phone in early 2017 “about how many “millionaires I’ve made in Buffalo” apropos of Innate stock.

Collins had recommended Innate stock to Price while the former HHS secretary was still a congressman from Georgia. The two participated in an in 2016 that awarded them Innate shares at a discount to the market price.

Unlike others, Price avoided the collapse in Innate stock because conflict-of-interest rules forced him to sell when he took over the reins at HHS in early 2017.

Sen. Ron Wyden, an Oregon Democrat who last year questioned the propriety of Collins’ and Price’s Innate investments, said the indictment shows “insiders getting special deals while working Americans are left in the dust.”

There was no indication in Wednesday’s indictment that Price, who resigned a few months later after Politico revealed he was taking private, chartered flights at taxpayer cost, was privy to inside information.

But seven people close to Collins were tipped off, prosecutors said, using the information to sell before the company announced the disappointing drug results. A few minutes after hearing from Innate’s CEO via email that the trial was a “clinical failure,” Collins called his son, Cameron, with the news, according to the indictment.

Cameron Collins quickly told four people, including his girlfriend and his girlfriend’s father, who told two others, filed Wednesday by the Securities and Exchange Commission. Shareholders receiving inside information and selling Innate shares were able to avoid total losses of $768,600, prosecutors said.

Innate shares plunged from 55 cents to a nickel after the company announced the clinical failure.

The government charged Chris Collins, his son and his son’s girlfriend’s father with 13 counts of securities fraud, wire fraud and false statements relating to the alleged scheme. Cameron Collins and Stephen Zarsky, the girlfriend’s father, also pleaded not guilty on Wednesday.

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Even as these patient groups grow in number and political influence, their funding and their relationships to drugmakers are little understood. Unlike payments to doctors and lobbying expenses, companies do not have to report payments to the groups.

The database, called “Pre$cription for Power,” shows that donations to patient advocacy groups tallied for 2015 鈥� the most recent full year in which documents required by the Internal Revenue Service were available 鈥� dwarfed the total amount the companies spent on federal lobbying. The 14 companies that contributed $116 million to patient advocacy groups reported only about $63 million in that same year.

Though their primary missions are to focus attention on the needs of patients with a particular disease 鈥� such as arthritis, heart disease or various cancers 鈥� some groups effectively supplement the work lobbyists perform, providing patients to testify on Capitol Hill and organizing letter-writing and social media campaigns that are beneficial to pharmaceutical companies.

Six drugmakers, the data show, contributed a million dollars or more to individual groups that represent patients who rely on their drugs. The database identifies over 1,200 patient groups. Of those, 594 accepted money from the drugmakers in the database.

The financial ties are troubling if they cause even one patient group to act in a way that’s “not fully representing the interest of its constituents,” said Matthew McCoy, a medical ethics professor at the University of Pennsylvania who co-authored a 2017 study about patient advocacy groups’ influence and transparency.

Notably, such groups have been silent or slow to complain about high or escalating prices, a prime concern of patients.

“When so many patient organizations are being influenced in this way, it can shift our whole approach to health policy, taking away from the interests of patients and towards the interests of industry,” McCoy said. “That’s not just a problem for the patients and caregivers that particular patient organizations serve; that’s a problem for everyone.”

Bristol-Myers Squibb provides a stark example of how patient groups are valued. In 2015, it spent more than $20.5 million on patient groups, compared with on federal lobbying and less than on major trade associations, according to public records and company disclosures. The company said its decisions regarding lobbying and contributions to patient groups are “unrelated.”

“Bristol-Myers Squibb is focused on supporting a health care environment that rewards innovation and ensures access to medicines for patients,” said spokeswoman Laura Hortas. “The company supports patient organizations with this shared objective.”

The first-of-its-kind database, compiled by Kaiser Health News, tallies the money from Big Pharma to patient groups. KHN examined the 20 pharmaceutical firms included in the S&P 500, 14 of which were transparent 鈥� in varying degrees 鈥� about giving money to patient groups.聽Pre$cription for Power is based on information contained in charitable giving reports from company websites and federal 990 regulatory filings.

It spotlights donations pharma companies made to patient groups large and small. The recipients include well-known disease groups, like the American Diabetes Association, with revenues of hundreds of millions of dollars; high-profile foundations like Susan G. Komen, a patient group focused on breast cancer; and smaller, lesser-known groups, like the Caring Ambassadors Program, which focuses on lung cancer and hepatitis C.

The data show that 15 patient groups 鈥� with annual revenues as large as $3.6 million 鈥� relied on the pharmaceutical companies for at least 20 percent of their revenue, and some relied on them for more than half of their revenue. The database explores only a slice of the pharmaceutical industry’s giving overall and will be expanded with more companies and groups over time.

“It’s clear that more transparency in this space is vitally important,” said Sen. Claire McCaskill (D-Mo.), who has been investigating the links between patient advocates and opioid manufacturers and is considering legislation to track funding. “This database is one step forward in that effort, but we also need Congress to act.”

What Drives The Money Flow

The financial ties between drugmakers and the organizations that represent those who use or prescribe their blockbuster medicines have been of growing concern as drug prices escalate. The Senate investigated conflicts of interest in the run-up to the passage of the 2010 Physician Payments Sunshine Act 鈥� a law that required payments to physicians from makers of drugs and devices to be registered on a public website 鈥� but patient groups were not addressed in the bill.

Some of the patient groups with ties to trade groups echo industry talking points in media campaigns and letters to federal agencies, and do little else. And patients, supported by pharma, are dispatched to state capitals and Washington to support research funding. Some groups send patients updates on the newest drugs and industry products.

“It’s through groups like this that patients often learn about illnesses and treatments,” said Rick Claypool, a research director for Public Citizen, a consumer advocacy group that says it pharmaceutical funding.

For the patient group Caring Ambassadors Program, industry funds are needed to make up for a lack of public funding, said the group’s executive director, Lorren Sandt. According to IRS filings and published company reports, in 2015 the group received $413,000, the bulk of which came from one company, AbbVie, which makes a hepatitis C treatment and has been testing a new lung cancer drug, Rova-T, not yet approved. She said the money had no influence on the Caring Ambassadors Program’s priorities.

“There aren’t a lot of large pockets of funding outside of the pharmaceutical money,” Sandt said. “We take it where we can find it.”

Other patient groups such as The National Women’s Health Network, based in Washington, D.C., make sacrifices to avoid pharmaceutical funding. That includes operating with a small staff in a “modest” office building with few windows and outdated computers, according to executive director Cindy Pearson. “You can see the effect of our approach to funding as soon as you walk [in] the door.”

Pearson said it’s hard for patient groups not to be influenced by the funder, even if they proclaim independence. Patient groups “build relationships with their funders and feel in sync and have sympathy” for them. “It’s human nature. It’s not evil or weak, but it’s wrong.”

Charity As Marketing

Patients newly diagnosed with a disease often turn to patient advocacy groups for advice, but the money flow to such groups may distort patients’ knowledge and public debate over treatment options, said Dr. Adriane Fugh-Berman, the director of PharmedOut, a Georgetown University Medical Center program that is critical of some pharmaceutical marketing practices.

“[The money flow limits] their advocacy agenda to competing branded products when the best therapy might be generics, over-the-counter drugs or diet and exercise,” she said.

AbbVie 鈥� whose specialty drug Humira made up of the company’s net revenue in 2017 and is used to treat patients with autoimmune diseases, including Crohn’s disease and certain kinds of arthritis 鈥� gave $2.7 million to the Crohn’s & Colitis Foundation and $1.6 million to the Arthritis Foundation, according to the company’s public disclosures included in the database. The list price for a month’s supply of Humira, a biologic drug, is $4,872, according to Express Scripts, a pharmacy benefits manager.

Even though Humira will face competition from near-copycat drugs called biosimilars, it is expected to remain the highest-grossing drug in the United States through 2022, according to drug industry analysts at .

The Arthritis and Crohn’s foundations have been largely silent on the cost of Humira and vocal on safety concerns about biosimilars. The Arthritis Foundation has championed state laws that could add extra steps for consumers to receive biosimilars at the pharmacy counter, potentially keeping more patients on the brand-name drug. Experts say those laws could help protect Humira’s market share from generic competitors.

A coalition of patient groups, Patients for Biologics Safety & Access, opposes the automatic substitution of a cheaper biosimilar when doctors prescribe a biologic. In 2015, members of that coalition, including the Crohn’s & Colitis Foundation, the Arthritis Foundation and the Lupus Foundation of America, accepted about $9.1 million from pharmaceutical companies in the database, according to public disclosures. They include AbbVie and Johnson & Johnson, makers of blockbuster biologics.

The Arthritis Foundation did not deny receiving the money but said the foundation represents patients, not sponsors. It is “optimistic” about biosimilars’ ability to help patients and save them money, said Anna Hyde, vice president of advocacy and access. “The Foundation supports the Food and Drug Administration’s scientific standards in evaluating the safety and efficacy of biosimilars, and we support policies that encourage innovation and foster a competitive marketplace.”

(Story continues below.)

The Crohn’s & Colitis Foundation maintains “more than an arm’s-length distance” from its donors in the pharmaceutical industry, who have no say over the foundation’s strategic objectives, said president and CEO Michael Osso.

He added that the foundation’s position on biosimilars is “evolving.”

Lupus Foundation CEO Sandra Raymond said she could not explain how her group, also based in Washington, was involved in the coalition. She confirmed the Lupus Foundation received $444,000 from Pfizer in 2015 but said the money was not linked to any relationship with Patients for Biologics Safety & Access.

“I never went to a meeting,” Raymond said. “A former employee signed us up for a whole host of coalitions. I think we put our name on something or someone did.”

She said the Lupus Foundation was no longer a member of the coalition. Days after Kaiser Health News reached out to the coalition, its website was updated, excluding the Lupus Foundation.

For its part, AbbVie 鈥� which overall donated $24.7 million to patient groups in 2015, according to the new database 鈥� stipulates that its grants to nonprofits are “non-promotional” and provide no direct benefit to its business, according to a company statement. The company gives to patient groups because they serve as an “important, unbiased and independent resource for patients and caregivers.”

Insulin And Influence

The American Diabetes Association said in an email to KHN that it received $18.3 million in pharmaceutical funding in 2017, accounting for 12.3 percent of its revenue; that was down from $26.7 million in 2015. The money flowed in as insulin makers continued to hike prices in those years 鈥� up to four times per product 鈥� leading to hardships for patients.

The only “Big Three” insulin maker in the database, Eli Lilly, gave $2.9 million to the American Diabetes Association in 2015, according to disclosures from the company and its foundation. Sanofi and Novo Nordisk are the other two major insulin makers, but neither was in the S&P 500 and therefore not included in the database. Over the past 20 years, Eli Lilly has repeatedly raised prices on its bestselling insulins, Humalog and Humulin, even though the medicines have been around for decades. The drugmaker faced protests 鈥� by people demanding to know the cost of manufacturing a vial of insulin 鈥� at its Indianapolis headquarters last fall.

The ADA launched a campaign decrying “skyrocketing” insulin in late 2016 but did not call out any drugmaker in its literature. When legislators in Nevada passed a bill last year requiring insulin makers to disclose their profits to the public, the ADA did not take a public stance.

The American Diabetes Association said it doesn’t confront individual companies because it is seeking action from “all entities in the supply chain” 鈥� manufacturers, wholesalers, pharmacy benefit managers and insurers.

“As a public health organization, the ADA’s commitment and focus is on the needs of the more than 30 million people with diabetes,” said Dr. William Cefalu, its chief scientific and medical officer. “The ADA requires support from a diverse set of partners to achieve this objective.”

Eli Lilly said it contributes money to the American Diabetes Association because the two share a “common goal” of helping diabetes patients.

“We provide funding for a wide variety of educational programs and opportunities at ADA, and they design and implement those programs in ways that are aligned with their goals,” Eli Lilly said in a statement. “We’re proud to support the ADA on important work that helps millions of people living with diabetes.”

Most patient groups say that funders have little or no influence in shaping their programs and policies, but their agreements are private.

They Weren’t Always Backed By Pharma

Into the ’80s and early ’90s, patient lobbying was generally limited and self-funded with only one or two affluent patients from an organization traveling to Washington on a given day, said Diana Zuckerman, president of the nonprofit National Center for Health Research.

But the power of patient-lobbyists became apparent after a successful campaign by AIDS patients led to government action and a national push to find drugs to treat the then-terminal disease. Zuckerman said she will never forget when two women visited her office and asked how breast cancer patients could be as effective as the AIDS patients.

“At the time, there were no breast cancer patients advocating for money or anything else. It’s hard to believe,” she said. “I still remember that conversation, because it was really a turning point.”

Soon after, breast cancer patients started visiting the Hill more frequently. Patients with other diseases followed. Over time, patients’ voices became a potent force, often with industry support.

Even some wealthy, high-profile organizations take industry money: For example, $459,000 of Susan G. Komen’s $118 million in 2015 revenue came from drugmakers in the database, according to public disclosures. Asked about the pharma money, the foundation said it has institutional processes in place to ensure that “no corporate partner 鈥� pharma or otherwise 鈥� decides our mission priorities,” including a scientific advisory board 鈥� free of sponsor influence 鈥� that reviews its research program.

Today, patient advocacy groups flush with more industry dollars fly patients in for testimony and training about how to lobby for their drugs.

Some years ago, as the groups increased in number, Zuckerman said, she started getting email invitations from advocacy groups to attend so-called lobbying days explicitly sponsored by the pharmaceutical industry. The hosts often promised training and usually some kind of keynote speaker at a luncheon in Washington 鈥� plus a potential scholarship to cover travel. Now, lobbying days involving dozens of patients from a single group are part of the landscape.

Dan Boston, president of lobbying firm Health Policy Source, said, “It would be naive to think these people on a Tuesday afternoon just happen to turn up in XYZ places,” adding that the money isn’t necessarily a bad thing. Money tends to flow toward citizen groups that already have the same priorities as their funders, he said.

Marching Into The Future

Patient groups have been successful at campaigning for drug approvals, at times sparking controversy.

When scientists within the FDA advised against the approval of Exondys 51, a drug to treat Duchenne muscular dystrophy, parents of children with the rare genetic disorder and patients rallied to lobby for it in Washington. They were seen as pivotal to the FDA’s 2016 decision to grant approval for the drug, made by Sarepta Therapeutics. The decision was controversial in part because the FDA noted that clinical benefits of the drug 鈥� aimed at a subset of people with Duchenne muscular dystrophy 鈥� were not yet established.

Sarepta Therapeutics, which is not featured in the database, has taken measures to support its patient base. In March, it announced an annual scholarship program 鈥� 10 grants of up to $10,000 each for students with Duchenne muscular dystrophy to attend university or trade schools. Sarepta Therapeutics is also among the funders of Parent Project Muscular Dystrophy, a patient advocacy group at the forefront of the push for Exondys 51’s approval.

The Pre$cription for Power database will grow to include new disclosures. Not all drugmakers are willing to disclose their company giving. Eleven of the 20 companies examined 鈥� Allergan, Baxter International, Biogen, Celgene, Endo International, Gilead Sciences, Mallinckrodt, Mylan, Perrigo Co., Regeneron Pharmaceuticals and Vertex Pharmaceuticals 鈥� declined to disclose their company giving or did not respond to repeated calls.

Paul Thacker, a former investigator for Sen. Chuck Grassley (R-Iowa) who helped draft the Physician Payments Sunshine Act in 2010, said there is reason to question the flow of money to patient advocacy groups. The pharmaceutical industry has fostered relationships in every link of the drug supply chain, including payments to researchers, doctors and professional societies.

“There’s so much money out there, and they’ve created all of these allies, so nobody is clamoring for change,” Thacker said.

Since the Physician Payments Sunshine Act began requiring the industry to report its payments to physicians, the industry is more reluctant to co-opt them, so “pharma has to find other megaphones,” PharmedOut’s Fugh-Berman said.

And in times of public outrage over high drug prices and soaring insurance costs, patients are particularly sympathetic messengers, she said.

“Sick consumers make for good press,” Fugh-Berman said. “They make for good testimony before Congress. They can be very powerful spokespeople for pharmaceutical companies.”

To learn how Kaiser Health News created the Pre$cription for Power聽database, read the full methodology, here.

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The short, technical paragraph calls for the Internal Revenue Service to allow patients with high-deductible health plans to receive care for chronic diseases, including drugs, before meeting their deductibles.

This allowance, known as a “safe harbor,” could be welcome news for patients with chronic conditions like diabetes or asthma stuck with skimpy plans. For example, a diabetes patient could fill her prescription for insulin with just a copay, even if she hadn’t spent enough on medical bills for her insurance coverage to kick in. But in the long term, experts say, extending a safe harbor to chronic care would encourage more employers to adopt these skimpy plans, while shielding the pharmaceutical industry from pressure to lower drug costs.

“It’s hard to view this as anything but a substantial win for pharma,” said Kim Monk, a partner and pharmaceutical expert at Capital Alpha Partners, which tracks laws and regulations for financial institutions.

High-deductible health plans have surged in the past five years.聽The U.S. Centers for Disease Control and Prevention estimates almost of patients ages 18-64 must pay $1,300 before receiving insurance coverage, and families must pay at least $2,600.聽And when faced with high drug prices, more of these patients skip filling prescriptions. Of the millions of insured Americans who struggle to pay their medical bills, skip filling a prescription due to cost according to a 2016 Kaiser Family Foundation poll. (Kaiser Health News is an editorially independent program of the foundation.)

These high-deductible health plans are likely to grow if the GOP health plan becomes law, the Congressional Budget Office.

But should the White House call on the IRS to offer a safe harbor for chronic disease medications, patients may visit the pharmacy more often despite the high deductibles.

“Yes, this provision could alleviate some of the pharmaceutical industry’s concerns about the increased cost-sharing patients with high-deductible plans could expect under the Republican health care bills,” said Rachel Sachs, an associate professor of law at Washington University in St. Louis who studies the pharmaceutical industry. “As the draft order notes, if high-deductible plan enrollees with chronic conditions can lower out-of-pocket costs for some of their medications, they will be more likely to adhere to their treatment regimens.”

The language of the draft executive order could signal a significant expansion of drug coverage for the growing population with high-deductible plans, according to Stacie Dusetzina, assistant professor of pharmacy and public health at the University of North Carolina-Chapel Hill. Under the Affordable Care Act, preventive drugs were covered before the deductible was met, but the provision was “quite narrowly defined and did not include medications that are used to prevent the progression of disease,” Dusetzina said. “Instead, it was more about preventing the disease altogether. In that way, the executive order could have a big impact on patient access to drugs.”

But unlike coverage under Medicaid or under a plan with a higher actuarial value, the IRS would determine what care and medications are covered. It’s not yet clear whether the safe harbor would extend to essential HIV drugs, insulin or expensive drugs that treat rare diseases.

“You’re asking the IRS to define something the IRS has never had to define before,” said Monk.

The draft executive order explains that the expanded coverage is “for the purpose of helping patients adhere to clinical regimes and thereby reducing the cost of care.” For instance, a patient who can afford an inhaler is less likely to be admitted to the hospital for wheezing. But whether this compliance reduces the cost of care in the long term depends on treatment costs and drug costs,聽Sachs said.

The safe harbor for chronic care has been championed by the Smarter Health Care Coalition, a partnership linking industry heavyweights including America’s Health Insurance Plans (AHIP), the insurers’ lobbying group; the U.S. Chamber of Commerce; Novo Nordisk; and Pfizer.

The safe harbor will make high-deductible health plans more attractive to employers, according to Tracy Watts, a senior partner at benefits firm Mercer, which could prompt insurers to supply them. “Such a change would go a long way toward encouraging more employers to offer [high-deductible] plans and would boost enrollment,” Watts wrote in a blog post.

The White House has not issued an official executive order on drug prices yet. The draft order, first obtained by The , has been overshadowed by the political drama over the health bill on the Hill.

Major trade groups have largely avoided shedding political capital on the congressional health care fight 鈥� among the most conspicuously absent: PhRMA, the Biotechnology Innovation Organization and the Association for Accessible Medicines, the generic-medicines lobby.

Pharmaceutical companies would see a $2.7 billion annual tax break, but that money would be eclipsed by losses in revenue from Medicaid and Medicare, as well as the drop in demand for health care from the millions of newly uninsured, Moody’s .

PhRMA won’t yet say whether it supports the chronic-care safe harbor. “We can’t speak to what the administration will do on this issue and don’t think it would be appropriate to speculate,” said Holly Campbell, deputy vice president of public affairs at PhRMA.

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Senior administrative officials met Friday to discuss an executive order on the cost of pharmaceuticals, a roundtable informed by聽Trump’s “Drug Pricing and Innovation Working Group.” Kaiser Health News examined documents that shed light on the workings of this working group.

The documents reveal behind-the-scenes discussions influenced by the pharmaceutical industry. Joe Grogan, associate director of health programs for the Office of Management and Budget (OMB), has led the group. Until March, Grogan served as a lobbyist for Gilead Sciences, the pharmaceutical company that priced its hepatitis C drugs at $1,000 per pill.

To solve the crisis of high drug prices, the group discussed strengthening the monopoly rights of pharmaceuticals overseas, ending discounts for low-income hospitals and accelerating drug approvals by the Food and Drug Administration. The White House declined to comment on the working group.

The group initially met May 4 in the Eisenhower Executive Office Building and has since met every two weeks. 聽In addition to OMB, the working group includes officials from the White House National Economic Council, Domestic Policy Council, Health and Human Services, the FDA, the Federal Trade Commission, the Department of Commerce, the Office of the U.S. Trade Representative and the Department of Justice.

According to the documents 鈥� the latest of which is dated June 1鈥� the working group focused on the following “principles” and “talking points”:

1. Extending the patent life of drugs in foreign markets to “provide for protection and enforcement of intellectual property rights.” This will ensure “that American consumers do not unfairly subsidize research and development for people throughout the globe.”

Extending monopoly protections for drugs overseas has been one of the pharmaceutical industry’s top priorities since the Trans-Pacific Partnership was defeated last year.

That policy would push up global drug prices, Médecins Sans Frontières.

1. Promoting competition in the U.S. drug market 鈥� both by “modernizing our regulatory and reimbursement systems” and limiting “barrier to entry, including the cost of research and development,” according to the documents.

The working group also discussed two broad policy ideas that have been championed by the pharmaceutical industry, according to sources familiar with the process:

1. Value-based pricing, when pharmaceutical companies keep the list prices of drugs unchanged but offer rebates if patients don’t improve. It’s unclear who would audit the effectiveness of the drugs, what criteria they would use to evaluate them and who would receive the rebates. Grogan invited Robert Shapiro 鈥� an adviser for Gilead and former secretary of Commerce under President Bill Clinton 鈥� to on value-based pricing on May 18. Shapiro is the chairman and co-founder of Sonecon LLC, a Washington, D.C., firm that consulted with Gilead, Amgen and PhRMA, according to his curriculum vitae.

1. Grogan and Shapiro also discussed issuing 10-year U.S. Treasury bonds to drug manufacturers to pay for expensive, hepatitis C drugs like Sovaldi and Harvoni under Medicare and Medicaid, to avoid rationing drugs to the sickest patients. The 2015 Senate investigation, for example, found that though Medicaid spent more than $1 billion on Sovaldi, just 2.4 percent of Medicaid patients with hepatitis C were treated.

After the working group’s first meeting on May 4, Grogan distributed detailed policy recommendations on expediting generic drug approvals, creating a new tax credit “of up to 50 percent” for investments in generic drug manufacturing, distribution and research and development. The documents also propose scaling back the 340B program, which requires drug manufacturers to provide some medicines at a discount to hospitals that treat low-income patients.

Most of these policies would not ease patient costs, and at least one would increase prices, say experts who reviewed the documents at the request of Kaiser Health News.

“This six-page document contains the kind of solutions to the cost-of-drugs problem that you would get if you gathered together all the executives of pharma and asked them 鈥榃hat sort of token gestures can we do?’ ” said Vinay Prasad, a professor of medicine at Oregon Health and Sciences University who studies the costs of cancer drugs.

The pharma-friendly recommendations appear to clash with聽 indicating that OMB Director Mick Mulvaney was considering requiring drugmakers to pay rebates to Medicare patients, a measure the pharmaceutical lobby fiercely opposes.

Brand-name drug prices 鈥� which account for 72 percent of drug spending 鈥� go untouched in the handouts, said Fiona Scott Morton, a Yale economics professor and former attorney with the Justice Department’s antitrust division.

“The changes to generic markets to promote competition look helpful, but there need to be some more ideas to create more competition for branded drugs or consumers aren’t really going to notice this,” Scott Morton said.

Some of the text in the document is cribbed directly from policy papers published by the pharmaceutical industry’s powerful lobby 鈥� Pharmaceutical Research and Manufacturers Association (PhRMA).

Under the subtitle, “Encourage Use of 21st Century Tools for Drug Evaluation, Review and Approval,” one handout proposes the FDA use less rigorous clinical trial standards to speed drug approvals.

The handout cites a PhRMA paper from March 2016 that includes an identical subtitle, “Encourage Use of 21st Century Tools for Drug Evaluation, Review and Approval,” and recommends the FDA implement less rigorous clinical trial standards.

These recommendations would not lower drug prices, experts say.

Such measures “would be like a firefighter spraying gasoline on your burning garage,” Prasad said.

Another section 鈥� which recommends giving the FDA more discretion to evaluate generic copies of complex drugs 鈥� closely resembles a written by two lobbyists in the pharmaceutical division of Foley & Lardner, whose clients include generic drugmakers.

The handouts further recommend allowing drugmakers to supply data and off-label information to insurers and pharmacy benefit managers during the clinical trial period, before they secure FDA approval.

That’s a “terrible idea,” said Jerry Avorn, a professor at Harvard Medical School and the chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. “That’s why we have the whole approval process, to determine what’s actually true,” he said.

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For many, the essence of gathering at conferences is the sharing of scientific information, a peek at interesting research in progress.

The policy, unusual for scientific conferences, is the most public manifestation yet of the tension between the drug and medical device companies that help sponsor the ADA’s flagship programs on one side and researchers and patients on the other.

The New England Journal of Medicine doesn’t consider this a problem. Some researchers on Twitter pointed to NEJM guidelines that state “online posting of an audio or video recording of an oral presentation at a medical meeting, with selected slides from the presentation, is not considered prior publication,” according to .

Each year, academic and industry researchers present cutting-edge and sometimes unpublished data at the ADA’s Scientific Sessions. Many of these researchers accept research grants or consulting contracts from insulin makers and other pharmaceutical companies, according to on the conference’s website. The nonprofit’s website shows it accepted corporate sponsorships of up to $135,000 to advertise at the conference in a , including promotional handouts at hotel check-ins, ads in the meeting guide and marketing materials in the goody bag distributed to participating physicians. The conference’s was sponsored by Sanofi, one of the “big three” insulin makers.

But the $500-$900 preclude many physicians, researchers and patients from attending.

Conference attendees who live-tweeted photos of presentation slides were quickly rebuked by the ADA. The nonprofit’s social media team tweeted at attendees to delete their photos. The comprehensive policy even applied to sessions about open innovation, an irony not lost on patients and researchers keeping up online with the conference, which concluded Tuesday.

The first rule of open invitation: You don't talk about open innovation. @shivani_go

鈥� Matthew Dalby (@MatthewJDalby)

“I am not familiar enough with the ADA to have an informed opinion on their no photo-taking policy as a general matter. In this particular case, the application of the no-photos policy to a to 鈥� and increasing ability to 鈥� design treatments for themselves did seem like a funny juxtaposition,” said the researcher, Eric von Hippel, the T. Wilson Professor in Management at MIT.

Still, some rogue attendees tweeted photos anyway, only to find that representatives of the American Diabetes Association were enforcing the policy in person, too.

Excuse the poor focus 鈥� taking photos at has turned into a covert activity. Executive summary: the lockstep slides look damning.

鈥� Thom Scher (@thomscher)

Defending the unpopular policy, Linda Cann, ADA’s senior vice president of professional services and education, cited legal concerns in a to .

“All research slides and posters are the legal property of each of the research authors and their study team, not the Association,” Cann said. “Reversing this policy could unwittingly dismantle the long-standing discourse and engagement of medical and research meetings around the world.

“After this year’s meeting, we will re-evaluate the policy and our legal obligations to the researchers who present at Scientific Sessions.”

Cann did not explain which legal obligations concerned the ADA. Independent academics are not typically litigious when it comes to intellectual property. Pharmaceutical and medical device companies might worry about breaking Food and Drug Administration rules prohibiting marketing a product before regulatory approval.

Some in the diabetic online community have speculated that a snafu at last year’s sessions contributed to this year’s zealous enforcement. In 2016, sensitive data about a new Novo Nordisk drug, Victoza, was shared with conference attendees an hour before its official release to the markets, and the data was immediately shared on Twitter, according to a Bloomberg . Novo’s stock dipped by 5.6 percent the following day.

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Many of the 1.25 million Americans who live with Type 1 diabetes cheered the legislative effort in Nevada as an important first step in their fight against skyrocketing costs of a drug on which their lives depend. The cost of insulin medications has steadily risen over the past decade .

Prominent patient advocacy groups, like the American Diabetes Association, have maintained stony silence while diabetes patients championed the bill and lobbied the legislature during this debate 鈥� a silence that patients and experts say stems from financial ties.

“Normally all of the patient advocacy groups rally around causes and piggyback on each other in a productive way 鈥� that’s what advocacy groups are good at 鈥� but that hasn’t been the case here,” said Thom Scher, chief operating officer of Beyond Type 1, which does not accept donations from the pharmaceutical industry. Beyond Type 1 has not issued a formal opinion on the Nevada bill.

In 2016, two of the “big three” insulin producers 鈥� Eli Lilly and Sanofi 鈥� contributed at least $4.7 million to such national patient advocacy groups as the American Diabetes Association, Diabetes Patient Advocacy Coalition (DPAC), JDRF International and the Diabetes Hands Foundation, according to company disclosures. The third major insulin manufacturer, Novo Nordisk, does not disclose its charitable contributions.

The advocacy groups have taken no position on the Nevada legislation. Generally speaking, their advocacy focuses on pressuring insurers to pay the price of insulin, not protesting price rises.

Local diabetes groups, hardly free from conflicts with the pharmaceutical industry, have also stayed on the sidelines.

The Nevada Diabetes Association for Children and Adults officially issued a neutral opinion.

“The Nevada Diabetes Association supports regulations on medications. The problem with SB 265 is that it is not just regulating medication but the industry,” said Executive Director Sarah Gleich.

The nonprofit does not list its financial supporters on its website or most recent 990 tax form.

“We disclose what we have received, and the IRS does not require that we publicly publish from whom,” Gleich said. “No one is giving out their invitation list to the party.”

Gleich said the Nevada Diabetes Association receives table sponsorships and supplies for camp programs from the pharmaceutical industry but “nothing that would make a dent on the budget.” Auditing non-monetary donations in order to meet the bill’s transparency requirement would be burdensome, Gleich said.

Membership dues accounted for only about $6,000 of the group’s $320,000 in revenue , according to its latest tax form.

The American Diabetes Association 鈥� which operates a 鈥� accepted at least $3.9 million from Eli Lilly and Sanofi last year.

“The American Diabetes Association believes that no individual in need of lifesaving medications such as insulin should ever go without due to prohibitive costs,” Michelle Kirkwood, its director of strategic communications and media relations, said in a statement. She would not say whether the nonprofit supports the bill.

Former American Diabetes Association president Larry Hausner wrote an opposing the legislation. “Caring for people with diabetes involves more than what they pay for insulin or another medication,” Hausner wrote. “As a lifelong patient advocate, I know Nevadans expect more out of their elected officials.” Hausner, now the president of a consulting and public affairs firm, serves on the board of directors of Research!America, a nonprofit promoting increased federal funding for public health research, alongside Sanofi’s president of global research & development, Elias Zerhouni.

The Diabetes Hands Foundation expressed neutrality on the bill. “This state priority in Nevada is a good step towards a larger conversation about the costs of chronic care conditions like diabetes,” said the foundation’s director of advocacy, Mandy Jones. “But it’s hard to know the particular outcome of this particular bill in the U.S. market.”

JDRF International would not comment. DPAC deferred questions to the National Diabetes Volunteer Leadership Council.

Against the backdrop of silence from these patient advocacy groups, a community of diabetes patients on Twitter elevated the bill’s profile around the hashtag #insulin4all, created by T1International, a group in the United Kingdom that does not accept pharmaceutical donations.

“People feel frustrated. At the federal level, we’re not being seen because there’s so much going on politically,” said Erin Gilmer, a聽Colorado advocate with Type 1 diabetes. “It might have to be a state-by-state movement.”

Sen. Yvanna Cancela, who sponsored the bill, said she believed requiring diabetes advocacy groups to reveal their sources of funding was key to understanding their positions and bringing prices down. “I believe there should be transparency across the health care system,” Cancela said.

Gov. Brian Sandoval Monday night that , according to a Nevada Independent reporter. If the governor takes no action, the transparency rules become law. The bill, SB539, incorporates provisions of an earlier bill approved by the legislature but vetoed by Sandoval. Sponsors stripped a controversial provision that would have required insulin manufacturers to warn patients 90 days before raising prices, which stoked concerns about drug stockpiling, the Associated Press .

The Nevada bill “is definitely a step in the right direction,” said Elizabeth Rowley, founder and director of T1International. “Almost anything requiring more transparency is incredibly important right now, especially at a time when almost all diabetes patient advocacy groups take funding from drug and device companies.”

Laura Marston, an advocate in Washington, D.C., with Type 1 diabetes, said that there is plenty of grass-roots support for legislation on insulin prices but that advocacy organizations are not listening to the right people.

“There should be more focus on the one thing we need to survive. 鈥� Without insulin, I die a horrendous death in 12 to 24 hours,” Marston said. “No grass-roots support? There’s desperation.”

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The story cited unnamed sources who told the newspaper that the office began sending letters to investors seeking information about a month ago. Legally, they are not required to provide it or submit to interviews.

The ethics office investigators interviewed several investors from the Buffalo, N.Y., area on Monday and Tuesday, according to the story. Collins, a Republican who is a prominent ally of President Donald Trump’s, represents a district in the Buffalo area.

The newspaper said the probe focuses on investments in Innate Immunotherapeutics, a company whose stock Collins first bought in 2005. Others with ties to Collins 鈥� some of them campaign donors 鈥� later became investors, too. They included executives at Buffalo-area companies and institutions, such as a physician at Roswell Park Cancer Institute in Buffalo.

Collins’ spokesman said in a statement that his boss had done nothing wrong.

“Despite the continued partisan attacks insinuating otherwise, Congressman Collins has followed all ethical guidelines related to his personal finances during his time in the House and will continue to do so,” Collins aide Michael Kracker said.

The company fell into a political controversy late last year when former congressman聽Tom Price 鈥� now the secretary of Health and Human Services 鈥� was identified as an investor. News reports about Collins’ and Price’s holdings in Innate raised questions about whether they benefited from legislation that could help Innate.

Price said at his confirmation hearing this year that he bought Innate stock after Collins told him about the company. He later sold the stock as he had promised, Price recently, and tripled his investment.

Public Citizen, a government watchdog group, asked the ethics office to open an investigation into Collins’ activities in February, citing a Kaiser Health News about the congressman. The office has received at least four complaints about Collins’ involvement with Innate, The Buffalo News reported.

Sources told the newspaper that they were unsure whether聽the ethics probe would lead to further action. Most investigations do not, the Office of Congressional Ethics has said.

If it finds wrongdoing, the office can refer allegations to the House Committee on Ethics for potential disciplinary action.

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A PhRMA , Scott LaGanga, for 10 years led the Partnership for Safe Medicines, a聽 that has recently emerged as a leading voice against Senate bills that would allow drug importation from Canada. LaGanga was responsible for PhRMA alliances with patient advocacy groups and served until recently as the nonprofit’s principal officer, according to the partnership’s tax forms.

In February, LaGanga moved to a senior role at PhRMA and stepped down as executive director of the Partnership for Safe Medicines 鈥� just as the group’s campaign to stop import legislation was revving up.

Both PhRMA and the partnership have gone to great lengths to show that drugmakers are not driving what they describe as a “grass-roots” effort to fight imports 鈥� including an expensive advertising blitz and an event last week that featured high-profile former FBI officers and a former Food and Drug Administration commissioner.

The U.S. drug industry has strongly opposed efforts to open the borders to drug imports, but PhRMA is not mentioned in the partnership’s recent advertising blitz. The nonprofit said its grass-roots effort is supported by 170 members, including professional organizations and trade groups.

The nonprofit describes PhRMA as a dues-paying member with no larger role in shaping the group’s activities. Partnership spokeswoman Clare Krusing would not say how much each member contributes. PhRMA spokeswoman Allyson Funk declined to say whether PhRMA funds the partnership.

“PhRMA engages with stakeholders across the health care system to hear their perspectives and priorities,” Funk said. “We work with many organizations with which we have both agreements and disagreements on public policy issues, and believe engagement and dialogue are critical.”

LaGanga is listed as the nonprofit’s executive director on each of the partnership’s annual tax filings since 2007, the earliest year for which they are .

LaGanga wrote a about the partnership’s origins. Published in the Journal of Commercial Biotechnology, it described “public-private partnerships in addressing counterfeit medicines.” His PhRMA job was not disclosed.

From 2010 to 2014, the organization hosted a conference called the Partnership for Safe Medicines Interchange. At a 2013 event , LaGanga thanks pharmaceutical companies for sponsoring the event, most of them PhRMA members.

The partnership recently launched its ambitious ad campaign 鈥� including television commercials, promoted search results on Google and a full-page print ad in The Washington Post and The Hill. The group’s shows recent commercials targeted to viewers in 13 states.

“We don’t disclose specific ad figures, but the campaign is in the high six figures,” Safdar said.

The campaign warns against the alleged dangers of legalizing Canadian drug imports. The commercials ask voters to urge their senators to “oppose dangerous drug importation legislation.”

The newspaper ad reads, “Keep the nation’s prescription drug supply safe. Urge the Senate to reject drug importation measures.” Its splash headline declares that “170 healthcare advocacy groups oppose drug importation,” touting a . It lists 160, and PhRMA’s name is not included.

“Having a big membership allows the coalition to present what looks like a unified show of grass-roots support 鈥� but it does raise questions about which members of the coalition are really driving and funding the group’s policymaking,” said Matthew McCoy, a postdoctoral fellow at the University of Pennsylvania who studies patient advocacy groups.

The list of “grass-roots groups” includes at least 64 trade organizations representing the biomedical industry, professional associations representing pharmacists, a private research company and two insurance companies.

One group that signed the letter, the “Citrus Council, National Kidney Foundation of Florida Inc,” represents a single volunteer, according to an email from the group. A spokesman for the National Kidney of Foundation of Florida said the volunteer’s views contradict the position of the umbrella group, and said the foundation supports “any sort of drug importation that allows our patients to have access to drugs at the best price.”

Two of the hepatitis advocacy groups listed 鈥� the National Association of Hepatitis Task Forces and the California Hepatitis C Task Force 鈥� are run by the same person: Bill Remak. Remak said the groups receive small amounts of PhRMA funding.

“I don’t enjoy having to take this extreme position of saying we shouldn’t import at all, but until we have some oversight regime, some way of protecting consumers, it’s a really tough call,” he said in an interview.

“Current drug importation proposals do not appear to have equal safety and chain-of-custody accountability laid out adequately for patient safety concerns,” said William Arnold, president of the Community Access National Network, an advocacy and support group for people living with HIV/AIDS or hepatitis in Washington, D.C. His group聽did not accept money from PhRMA from 2013 to 2015.

Last week, the partnership hosted a panel at the National Press Club featuring former FBI director Louis Freeh and former FDA commissioner Dr. Andrew von Eschenbach. The discussion focused on the health and legal dangers of online pharmacies.

“You can talk about lowering prices, but if a drug comes with a high probability of toxicity and death, that comes at a high cost to the patient,” von Eschenbach said. “That’s what’s at issue with drug importation.”

Each聽speaker argued that the bill co-sponsored by Sen. Bernie Sanders (I-Vt.) would be harmful to patients. That legislation would provide a mechanism for Canadian drug manufacturers to sell to U.S. consumers and pharmacies. Sanders introduced the bill in February. Around the same time, the partnership sent emails to member organizations seeking help to stop such a measure.

In the House, Rep. Elijah Cummings (D-Md.) introduced a similar bill to Sanders’, along with 23 other聽Democrats. In January, Sens. John McCain (R-Ariz.) and Amy Klobuchar (D-Minn.) also to allow drug imports from Canada.

Speakers at the partnership event claimed importation would lead to a flood of counterfeit medicines laced with arsenic, fentanyl and lead paint.

“These drugs are manufactured in jungles, in tin drums, in basements 鈥� those are the sort of sanitary conditions we’re talking about here,” said George Karavetsos, a former director of the FDA’s Office of Criminal Investigations.

Josh Miller-Lewis, Sanders’ deputy director of communications, refuted those arguments in an interview. He said Canadian drugmakers can apply for licenses, and all drugs would have to come from FDA-inspected plants.

Both von Eschenbach and Karavetsos have ties to the pharmaceutical industry: Von Eschenbach left the FDA in 2009 to join Greenleaf Health, which counsels pharmaceutical clients, before starting his own consulting company; and Karavetsos at DLA Piper, a Washington, D.C., law firm.

This isn’t Sanders’ first attempt to legalize importation. But Politico reported in October that by another $100 million a year, suggesting to many industry watchers that drugmakers are gearing up for a ferocious fight.

“I think it’s safe to say pharmaceutical corporations are prepared to spend some fraction of their multibillion-dollar profits to fight drug importation and any other policy that might end the plague of overpriced medicine,” said Rick Claypool, research director for Public Citizen, a watchdog group critical of the drug industry.

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In a Wednesday, seven senators 鈥� six聽Democrats plus Vermont independent Bernie Sanders 鈥� called on Sessions to assure them that any investigation of Price 鈥� or others connected to the Trump administration 鈥� would be “allowed to continue unimpeded.” Three Democratic senators sent a different a day earlier, asking Sessions to “provide greater clarity” about why Manhattan’s former U.S. attorney, Preet Bharara, was fired and whether any investigation of Price was a factor in Bharara’s removal.

ProPublica, a nonprofit news organization, reported that Price was being by the U.S. attorney’s office for his stock trades, though it did not specify which trades Bharara was investigating before his dismissal. The website attributed its report to an unnamed person familiar with the U.S. attorney’s office, and neither the Justice Department nor other news media organizations have confirmed its existence.

If an investigation had begun, it would be hard to derail. But investigations of federal officials are always sensitive cases, said Donald Langevoort, a securities law professor at Georgetown University.

“The higher up the food chain you go, the more prominent the person is, the more confident you better be that you have the evidence you can present to a jury,” he said.聽“But I think any attempt to quash an investigation would backfire considerably.”

Price, a prominent Republican congressman until he joined President Donald Trump’s Cabinet this year, was questioned extensively at his confirmation hearings about he made in health care, pharmaceutical and medical device companies while serving on the House of Representatives’ health subcommittee.

The activity raised conflict-of-interest concerns for some members of Congress because Price’s trades overlapped with his sponsorship of bills, advocacy or votes on issues related to those companies or their industries.

The Democrats聽 called attention to Price’s investment in a small Australian biotech firm, Innate Immunotherapeutics, which Price testified he learned about from another congressman, Rep. Chris Collins聽(R-N.Y.), Innate’s largest .

Price bought most of his shares at discounted prices in two private stock placements in 2016 offered to a small number of sophisticated investors 鈥� many with personal or professional ties to Collins.

Congressional Democrats slammed Price at his hearings for buying shares at advantageous prices not available to all investors. Some questioned whether Price had violated insider trading laws or the Stop Trading on Congressional Knowledge (STOCK) Act, which bans members of Congress from trading on stocks using information they received in carrying out their official duties.

“Despite the many unanswered questions that remained, Republicans rushed Price’s nomination through the Senate without waiting for answers,” seven senators said in Wednesday’s letter.

When he was confirmed Feb. 10, Price agreed to divest his stock holdings within 90 days of 聽taking his post. An HHS spokesperson said Price has completed those divestitures but declined to provide further information.

Sen. Elizabeth Warren (D-Mass.) was the only senator who signed both letters to Sessions.

Other names on Wednesday’s letter were Patty Murray (D-Wash.), Ron Wyden (D-Ore.), Bernie Sanders (I-Vt.), Al Franken (D-Minn.), Tammy Baldwin (D-Wis.) and Maggie Hassan (D-N.H.).

Tuesday’s letter was also signed by Richard Blumenthal聽(D-Conn.) and Jeff Merkley (D-Ore.).

Sessions’ office confirmed it had received Tuesday’s letter from the senators but declined to comment on either one. The U.S. Attorney’s Office in Manhattan also had no comment.

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