Sydney Lupkin

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb, MD, called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid (lenalidomide), which accounted for 63% of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Ameet Sarpatwari, JD, PhD, of Harvard Medical School in Boston. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5% to 26.3% for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60% more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni (ledipasvir and sofosbuvir), which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40% per unit in just 4 years, the Medicare data show, and cost $75,200/beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Dr. Gottlieb said in a statement.

The Department of Health & Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Dr. Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Dr. Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition, and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst (pomalidomide) are believed to have similar risks,” Mr. Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer (bosentan). In 2016, that drug cost Medicare $90,700/patient and more than $304 million overall. Meanwhile, spending per unit jumped 52% from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactics. “With billions of dollars at stake, a database alone will not stop this behavior,” Sen. Leahy said.

Cosponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Dr. Sarpatwari said. “Why are they not stepping into this arena and saying that?”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News (hyperlink to khn.org) is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb, MD, called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid (lenalidomide), which accounted for 63% of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Ameet Sarpatwari, JD, PhD, of Harvard Medical School in Boston. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5% to 26.3% for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60% more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni (ledipasvir and sofosbuvir), which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40% per unit in just 4 years, the Medicare data show, and cost $75,200/beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Dr. Gottlieb said in a statement.

The Department of Health & Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Dr. Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Dr. Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition, and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst (pomalidomide) are believed to have similar risks,” Mr. Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer (bosentan). In 2016, that drug cost Medicare $90,700/patient and more than $304 million overall. Meanwhile, spending per unit jumped 52% from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactics. “With billions of dollars at stake, a database alone will not stop this behavior,” Sen. Leahy said.

Cosponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Dr. Sarpatwari said. “Why are they not stepping into this arena and saying that?”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News (hyperlink to khn.org) is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb, MD, called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid (lenalidomide), which accounted for 63% of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Ameet Sarpatwari, JD, PhD, of Harvard Medical School in Boston. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5% to 26.3% for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60% more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni (ledipasvir and sofosbuvir), which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40% per unit in just 4 years, the Medicare data show, and cost $75,200/beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Dr. Gottlieb said in a statement.

The Department of Health & Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Dr. Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Dr. Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition, and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst (pomalidomide) are believed to have similar risks,” Mr. Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer (bosentan). In 2016, that drug cost Medicare $90,700/patient and more than $304 million overall. Meanwhile, spending per unit jumped 52% from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactics. “With billions of dollars at stake, a database alone will not stop this behavior,” Sen. Leahy said.

Cosponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Dr. Sarpatwari said. “Why are they not stepping into this arena and saying that?”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News (hyperlink to khn.org) is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations.

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 – the most recent full year in which documents required by the Internal Revenue Service were available – 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 lobbying activities that same year.

Though their primary missions are to focus attention on the needs of patients with a particular disease – such as arthritis, heart disease or various cancers – 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 more than 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, Philadelphia, who coauthored 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,” Mr. 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 $2.9 million on federal lobbying and less than $1 million 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 – in varying degrees – about giving money to patient groups. 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 – with annual revenues as large as $3.6 million – relied on the pharmaceutical companies for at least 20% 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 – a law that required payments to physicians from makers of drugs and devices to be registered on a public website – 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 does not accept 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, 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 in Washington 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 – whose specialty drug Humira made up 65% 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 – 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 EvaluatePharma.

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.”

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 – which overall donated $24.7 million to patient groups in 2015, according to the new database – 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% 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 – up to four times per product – 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 best-selling insulins, Humalog and Humulin, even though the medicines have been around for decades. The drugmaker faced protests – by people demanding to know the cost of manufacturing a vial of insulin – 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” – 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, PhD, 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. Dr. 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 – pharma or otherwise – decides our mission priorities,” including a scientific advisory board – free of sponsor influence – 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, Dr. 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 – 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 – aimed at a subset of people with Duchenne muscular dystrophy – 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 – 10 grants of up to $10,000 each for students with Duchenne muscular dystrophy to attend university or trade schools. Sarepta 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 – Allergan, Baxter International, Biogen, Celgene, Endo International, Gilead Sciences, Mallinckrodt, Mylan, Perrigo Co., Regeneron Pharmaceuticals, and Vertex Pharmaceuticals – 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,” Mr. 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 Dr. 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,” Dr. Fugh-Berman said. “They make for good testimony before Congress. They can be very powerful spokespeople for pharmaceutical companies.”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations.

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 – the most recent full year in which documents required by the Internal Revenue Service were available – 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 lobbying activities that same year.

Though their primary missions are to focus attention on the needs of patients with a particular disease – such as arthritis, heart disease or various cancers – 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 more than 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, Philadelphia, who coauthored 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,” Mr. 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 $2.9 million on federal lobbying and less than $1 million 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 – in varying degrees – about giving money to patient groups. 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 – with annual revenues as large as $3.6 million – relied on the pharmaceutical companies for at least 20% 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 – a law that required payments to physicians from makers of drugs and devices to be registered on a public website – 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 does not accept 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, 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 in Washington 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 – whose specialty drug Humira made up 65% 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 – 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 EvaluatePharma.

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.”

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 – which overall donated $24.7 million to patient groups in 2015, according to the new database – 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% 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 – up to four times per product – 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 best-selling insulins, Humalog and Humulin, even though the medicines have been around for decades. The drugmaker faced protests – by people demanding to know the cost of manufacturing a vial of insulin – 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” – 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, PhD, 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. Dr. 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 – pharma or otherwise – decides our mission priorities,” including a scientific advisory board – free of sponsor influence – 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, Dr. 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 – 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 – aimed at a subset of people with Duchenne muscular dystrophy – 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 – 10 grants of up to $10,000 each for students with Duchenne muscular dystrophy to attend university or trade schools. Sarepta 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 – Allergan, Baxter International, Biogen, Celgene, Endo International, Gilead Sciences, Mallinckrodt, Mylan, Perrigo Co., Regeneron Pharmaceuticals, and Vertex Pharmaceuticals – 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,” Mr. 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 Dr. 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,” Dr. Fugh-Berman said. “They make for good testimony before Congress. They can be very powerful spokespeople for pharmaceutical companies.”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations.

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 – the most recent full year in which documents required by the Internal Revenue Service were available – 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 lobbying activities that same year.

Though their primary missions are to focus attention on the needs of patients with a particular disease – such as arthritis, heart disease or various cancers – 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 more than 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, Philadelphia, who coauthored 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,” Mr. 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 $2.9 million on federal lobbying and less than $1 million 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 – in varying degrees – about giving money to patient groups. 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 – with annual revenues as large as $3.6 million – relied on the pharmaceutical companies for at least 20% 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 – a law that required payments to physicians from makers of drugs and devices to be registered on a public website – 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 does not accept 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, 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 in Washington 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 – whose specialty drug Humira made up 65% 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 – 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 EvaluatePharma.

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.”

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 – which overall donated $24.7 million to patient groups in 2015, according to the new database – 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% 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 – up to four times per product – 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 best-selling insulins, Humalog and Humulin, even though the medicines have been around for decades. The drugmaker faced protests – by people demanding to know the cost of manufacturing a vial of insulin – 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” – 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, PhD, 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. Dr. 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 – pharma or otherwise – decides our mission priorities,” including a scientific advisory board – free of sponsor influence – 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, Dr. 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 – 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 – aimed at a subset of people with Duchenne muscular dystrophy – 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 – 10 grants of up to $10,000 each for students with Duchenne muscular dystrophy to attend university or trade schools. Sarepta 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 – Allergan, Baxter International, Biogen, Celgene, Endo International, Gilead Sciences, Mallinckrodt, Mylan, Perrigo Co., Regeneron Pharmaceuticals, and Vertex Pharmaceuticals – 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,” Mr. 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 Dr. 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,” Dr. Fugh-Berman said. “They make for good testimony before Congress. They can be very powerful spokespeople for pharmaceutical companies.”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Skyrocketing price tags for new drugs to treat rare diseases have stoked outrage nationwide. But hundreds of old, commonly used drugs cost the Medicaid program billions of extra dollars in 2016 vs. 2015, a Kaiser Health News data analysis shows. Eighty of the drugs – some generic and some still carrying brand names – proved more than 2 decades old.

Rising costs for 313 brand-name drugs lifted Medicaid’s spending by as much as $3.2 billion in 2016, the analysis shows. Nine of these brand-name drugs have been on the market since before 1970. In addition, the data reveal that Medicaid outlays for 67 generics and other nonbranded drugs cost taxpayers an extra $258 million last year.

Even after a medicine has gone generic, the branded version often remains on the market. Medicaid recipients might choose to purchase it because they’re brand loyalists or because state laws prevent pharmacists from automatically substituting generics. Drugs driving Medicaid spending increases ranged from common asthma medicines like Ventolin to over-the-counter painkillers such as the generic form of Aleve to generic antidepressants and heartburn medicines.

Among the stark examples:

• Ventolin, originally approved in 1981, treats and prevents spasms that constrict patients’ airways and make it difficult to breathe. When a gram of it went from $2.58 to $2.90 on average, Medicaid paid out an extra $54.5 million for the drug.
• Naproxen sodium, a painkiller originally approved in 1994 as brand-name Aleve, went from costing Medicaid an average of $0.72 to $1.70 a pill, an increase of 136%. Overall, the change cost the program an extra $10 million in 2016.
• Generic metformin hydrochloride, an oral type 2 diabetes drug that’s been around since the 1990s, went from an average 10 cents to 13 cents a pill from 2015 to 2016. Those extra 3 pennies per pill cost Medicaid a combined $8.3 million in 2016. And cost increases for the extended-release, authorized generic version cost the program another $6.5 million.

“People always thought, ‘They’re generics. They’re cheap,’ ” said Matt Salo, who runs the National Association of Medicaid Directors. But with drug prices going up “across the board,” generics are far from immune.

Historically, generics tend to drive costs lower over time, and Medicaid’s overall spending on generics dropped $1.6 billion last year because many generics did get cheaper. But the per-unit cost of dozens of generics doubled or even tripled from 2015 to 2016. Manufacturers of branded drugs tend to lower prices once several comparable generics enter a market.

Medicaid tracks drug sales by “units” and a unit can be a milliliter or a gram, or refer to a tablet, vial, or kit.

Old drugs that became far more expensive included those used to treat ear infections, psychosis, cancer, and other ailments:

• Fluphenazine hydrochloride, an antipsychotic drug approved in 1988 to treat schizophrenia, cost Medicaid an extra $8.5 million in 2016. Medicaid spent an average $1.39 per unit in 2016, an increase of 347% versus the year before.
• Depo-Provera was first approved in 1960 as a cancer drug and is often used now as birth control. It cost Medicaid an extra $4.5 million after its cost more than doubled to $37 per unit in 2016.
• Potassium phosphates – on the market since the 1980s and used for renal failure patients, preemies, and patients undergoing chemotherapy – cost Medicaid an extra $1.8 million in 2016. Its average cost to Medicaid jumped 290%, to $6.70 per unit.

A shortage of potassium phosphates began in 2015 after manufacturer American Regent closed its facility to address quality concerns, according to Erin Fox, PharmD, who directs the Drug Information Center at the University of Utah, Salt Lake City, and tracks shortages for the American Society of Health-System Pharmacists.

When generics enter a market, competition can drive prices lower initially. But, when prices sink, some companies inevitably stop making their drugs.

“One manufacturer is left standing … [so] guess who now has a monopoly?” Mr. Salo said. “Guess who can bring prices as far up as they want?”

According to a Food and Drug Administration analysis, drug prices decline to about half of their original price with two generic competitors on the market and to about a third of the original price with five generics available. But, if there’s only one generic, a drug’s price drops just 6 percentage points.

The increases paid by Medicaid ultimately fall on taxpayers, who pay for the drugs taken by its 68.9 million beneficiaries. And those costs eat “into states’ ability to pay for other stuff that matters to [every] resident,” said economist Rena Conti, PhD, a professor at the University of Chicago who coauthored a National Bureau of Economics paper about generic price hikes in July. The manufacturers’ list prices for the drugs named here also rose in 2016, according to Truven Health Analytics, which means customers outside Medicaid also paid more.

Ms. Conti said that about 30% of generic drugs had price increases of 100% or more the past 5 years.

Medicaid spending per unit doesn’t include rebates, which drug manufacturers return to states after they pay for the drugs upfront. Such rebates are extremely complicated, but generally start at the federally required 23.1% for brand-name drugs, plus supplemental rebates that vary by state, Mr. Salo said. Final rebate amounts are considered proprietary, he noted. “All rebates are completely opaque” … it’s “black-box stuff.”

Dr. Fox said drug prices also could jump when a pharmaceutical product changes ownership, gets new packaging, or just hasn’t had a price increase in a long time.

Recently named FDA Commissioner Scott Gottlieb, MD, has made increasing generic competition a core mission. Plans include publishing lists of off-patent drugs made by one manufacturer and preventing brand-name drugmakers from using anticompetitive tactics to stave off competition.

Doctors, pharmacists, and patients don’t always receive warning when a price hike is about to occur, Dr. Fox said.

“Sometimes, we will get notices. Other times, it’s like a bad surprise,” she said, adding that the amount of wiggle room for alternatives depends on the drug and the patient.

Following some price hikes, doctors can use fewer units of a drug or switch it out entirely, she said.

Ofloxacin otic, long used to treat swimmer’s ear, became so expensive when generic manufacturers exited the market that doctors started using eye drops in patients’ ears, Dr. Fox said.

When old drugs get more expensive, hospitals try to eliminate waste by making smaller infusion bags and keeping really expensive drugs in the pharmacy instead of stocked in readily available shelves and drawers. But that’s not always possible.

“These drugs do have a place in daily therapy. Sometimes they’re life-sustaining and sometimes they’re lifesaving,” said Michael O’Neal, a pharmacist at Vanderbilt University Medical Center, Nashville, Tenn. “In this case, you just need to take it on the chin, and you hope one day for competition.”



KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Skyrocketing price tags for new drugs to treat rare diseases have stoked outrage nationwide. But hundreds of old, commonly used drugs cost the Medicaid program billions of extra dollars in 2016 vs. 2015, a Kaiser Health News data analysis shows. Eighty of the drugs – some generic and some still carrying brand names – proved more than 2 decades old.

Rising costs for 313 brand-name drugs lifted Medicaid’s spending by as much as $3.2 billion in 2016, the analysis shows. Nine of these brand-name drugs have been on the market since before 1970. In addition, the data reveal that Medicaid outlays for 67 generics and other nonbranded drugs cost taxpayers an extra $258 million last year.

Even after a medicine has gone generic, the branded version often remains on the market. Medicaid recipients might choose to purchase it because they’re brand loyalists or because state laws prevent pharmacists from automatically substituting generics. Drugs driving Medicaid spending increases ranged from common asthma medicines like Ventolin to over-the-counter painkillers such as the generic form of Aleve to generic antidepressants and heartburn medicines.

Among the stark examples:

• Ventolin, originally approved in 1981, treats and prevents spasms that constrict patients’ airways and make it difficult to breathe. When a gram of it went from $2.58 to $2.90 on average, Medicaid paid out an extra $54.5 million for the drug.
• Naproxen sodium, a painkiller originally approved in 1994 as brand-name Aleve, went from costing Medicaid an average of $0.72 to $1.70 a pill, an increase of 136%. Overall, the change cost the program an extra $10 million in 2016.
• Generic metformin hydrochloride, an oral type 2 diabetes drug that’s been around since the 1990s, went from an average 10 cents to 13 cents a pill from 2015 to 2016. Those extra 3 pennies per pill cost Medicaid a combined $8.3 million in 2016. And cost increases for the extended-release, authorized generic version cost the program another $6.5 million.

“People always thought, ‘They’re generics. They’re cheap,’ ” said Matt Salo, who runs the National Association of Medicaid Directors. But with drug prices going up “across the board,” generics are far from immune.

Historically, generics tend to drive costs lower over time, and Medicaid’s overall spending on generics dropped $1.6 billion last year because many generics did get cheaper. But the per-unit cost of dozens of generics doubled or even tripled from 2015 to 2016. Manufacturers of branded drugs tend to lower prices once several comparable generics enter a market.

Medicaid tracks drug sales by “units” and a unit can be a milliliter or a gram, or refer to a tablet, vial, or kit.

Old drugs that became far more expensive included those used to treat ear infections, psychosis, cancer, and other ailments:

• Fluphenazine hydrochloride, an antipsychotic drug approved in 1988 to treat schizophrenia, cost Medicaid an extra $8.5 million in 2016. Medicaid spent an average $1.39 per unit in 2016, an increase of 347% versus the year before.
• Depo-Provera was first approved in 1960 as a cancer drug and is often used now as birth control. It cost Medicaid an extra $4.5 million after its cost more than doubled to $37 per unit in 2016.
• Potassium phosphates – on the market since the 1980s and used for renal failure patients, preemies, and patients undergoing chemotherapy – cost Medicaid an extra $1.8 million in 2016. Its average cost to Medicaid jumped 290%, to $6.70 per unit.

A shortage of potassium phosphates began in 2015 after manufacturer American Regent closed its facility to address quality concerns, according to Erin Fox, PharmD, who directs the Drug Information Center at the University of Utah, Salt Lake City, and tracks shortages for the American Society of Health-System Pharmacists.

When generics enter a market, competition can drive prices lower initially. But, when prices sink, some companies inevitably stop making their drugs.

“One manufacturer is left standing … [so] guess who now has a monopoly?” Mr. Salo said. “Guess who can bring prices as far up as they want?”

According to a Food and Drug Administration analysis, drug prices decline to about half of their original price with two generic competitors on the market and to about a third of the original price with five generics available. But, if there’s only one generic, a drug’s price drops just 6 percentage points.

The increases paid by Medicaid ultimately fall on taxpayers, who pay for the drugs taken by its 68.9 million beneficiaries. And those costs eat “into states’ ability to pay for other stuff that matters to [every] resident,” said economist Rena Conti, PhD, a professor at the University of Chicago who coauthored a National Bureau of Economics paper about generic price hikes in July. The manufacturers’ list prices for the drugs named here also rose in 2016, according to Truven Health Analytics, which means customers outside Medicaid also paid more.

Ms. Conti said that about 30% of generic drugs had price increases of 100% or more the past 5 years.

Medicaid spending per unit doesn’t include rebates, which drug manufacturers return to states after they pay for the drugs upfront. Such rebates are extremely complicated, but generally start at the federally required 23.1% for brand-name drugs, plus supplemental rebates that vary by state, Mr. Salo said. Final rebate amounts are considered proprietary, he noted. “All rebates are completely opaque” … it’s “black-box stuff.”

Dr. Fox said drug prices also could jump when a pharmaceutical product changes ownership, gets new packaging, or just hasn’t had a price increase in a long time.

Recently named FDA Commissioner Scott Gottlieb, MD, has made increasing generic competition a core mission. Plans include publishing lists of off-patent drugs made by one manufacturer and preventing brand-name drugmakers from using anticompetitive tactics to stave off competition.

Doctors, pharmacists, and patients don’t always receive warning when a price hike is about to occur, Dr. Fox said.

“Sometimes, we will get notices. Other times, it’s like a bad surprise,” she said, adding that the amount of wiggle room for alternatives depends on the drug and the patient.

Following some price hikes, doctors can use fewer units of a drug or switch it out entirely, she said.

Ofloxacin otic, long used to treat swimmer’s ear, became so expensive when generic manufacturers exited the market that doctors started using eye drops in patients’ ears, Dr. Fox said.

When old drugs get more expensive, hospitals try to eliminate waste by making smaller infusion bags and keeping really expensive drugs in the pharmacy instead of stocked in readily available shelves and drawers. But that’s not always possible.

“These drugs do have a place in daily therapy. Sometimes they’re life-sustaining and sometimes they’re lifesaving,” said Michael O’Neal, a pharmacist at Vanderbilt University Medical Center, Nashville, Tenn. “In this case, you just need to take it on the chin, and you hope one day for competition.”



KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Skyrocketing price tags for new drugs to treat rare diseases have stoked outrage nationwide. But hundreds of old, commonly used drugs cost the Medicaid program billions of extra dollars in 2016 vs. 2015, a Kaiser Health News data analysis shows. Eighty of the drugs – some generic and some still carrying brand names – proved more than 2 decades old.

Rising costs for 313 brand-name drugs lifted Medicaid’s spending by as much as $3.2 billion in 2016, the analysis shows. Nine of these brand-name drugs have been on the market since before 1970. In addition, the data reveal that Medicaid outlays for 67 generics and other nonbranded drugs cost taxpayers an extra $258 million last year.

Even after a medicine has gone generic, the branded version often remains on the market. Medicaid recipients might choose to purchase it because they’re brand loyalists or because state laws prevent pharmacists from automatically substituting generics. Drugs driving Medicaid spending increases ranged from common asthma medicines like Ventolin to over-the-counter painkillers such as the generic form of Aleve to generic antidepressants and heartburn medicines.

Among the stark examples:

• Ventolin, originally approved in 1981, treats and prevents spasms that constrict patients’ airways and make it difficult to breathe. When a gram of it went from $2.58 to $2.90 on average, Medicaid paid out an extra $54.5 million for the drug.
• Naproxen sodium, a painkiller originally approved in 1994 as brand-name Aleve, went from costing Medicaid an average of $0.72 to $1.70 a pill, an increase of 136%. Overall, the change cost the program an extra $10 million in 2016.
• Generic metformin hydrochloride, an oral type 2 diabetes drug that’s been around since the 1990s, went from an average 10 cents to 13 cents a pill from 2015 to 2016. Those extra 3 pennies per pill cost Medicaid a combined $8.3 million in 2016. And cost increases for the extended-release, authorized generic version cost the program another $6.5 million.

“People always thought, ‘They’re generics. They’re cheap,’ ” said Matt Salo, who runs the National Association of Medicaid Directors. But with drug prices going up “across the board,” generics are far from immune.

Historically, generics tend to drive costs lower over time, and Medicaid’s overall spending on generics dropped $1.6 billion last year because many generics did get cheaper. But the per-unit cost of dozens of generics doubled or even tripled from 2015 to 2016. Manufacturers of branded drugs tend to lower prices once several comparable generics enter a market.

Medicaid tracks drug sales by “units” and a unit can be a milliliter or a gram, or refer to a tablet, vial, or kit.

Old drugs that became far more expensive included those used to treat ear infections, psychosis, cancer, and other ailments:

• Fluphenazine hydrochloride, an antipsychotic drug approved in 1988 to treat schizophrenia, cost Medicaid an extra $8.5 million in 2016. Medicaid spent an average $1.39 per unit in 2016, an increase of 347% versus the year before.
• Depo-Provera was first approved in 1960 as a cancer drug and is often used now as birth control. It cost Medicaid an extra $4.5 million after its cost more than doubled to $37 per unit in 2016.
• Potassium phosphates – on the market since the 1980s and used for renal failure patients, preemies, and patients undergoing chemotherapy – cost Medicaid an extra $1.8 million in 2016. Its average cost to Medicaid jumped 290%, to $6.70 per unit.

A shortage of potassium phosphates began in 2015 after manufacturer American Regent closed its facility to address quality concerns, according to Erin Fox, PharmD, who directs the Drug Information Center at the University of Utah, Salt Lake City, and tracks shortages for the American Society of Health-System Pharmacists.

When generics enter a market, competition can drive prices lower initially. But, when prices sink, some companies inevitably stop making their drugs.

“One manufacturer is left standing … [so] guess who now has a monopoly?” Mr. Salo said. “Guess who can bring prices as far up as they want?”

According to a Food and Drug Administration analysis, drug prices decline to about half of their original price with two generic competitors on the market and to about a third of the original price with five generics available. But, if there’s only one generic, a drug’s price drops just 6 percentage points.

The increases paid by Medicaid ultimately fall on taxpayers, who pay for the drugs taken by its 68.9 million beneficiaries. And those costs eat “into states’ ability to pay for other stuff that matters to [every] resident,” said economist Rena Conti, PhD, a professor at the University of Chicago who coauthored a National Bureau of Economics paper about generic price hikes in July. The manufacturers’ list prices for the drugs named here also rose in 2016, according to Truven Health Analytics, which means customers outside Medicaid also paid more.

Ms. Conti said that about 30% of generic drugs had price increases of 100% or more the past 5 years.

Medicaid spending per unit doesn’t include rebates, which drug manufacturers return to states after they pay for the drugs upfront. Such rebates are extremely complicated, but generally start at the federally required 23.1% for brand-name drugs, plus supplemental rebates that vary by state, Mr. Salo said. Final rebate amounts are considered proprietary, he noted. “All rebates are completely opaque” … it’s “black-box stuff.”

Dr. Fox said drug prices also could jump when a pharmaceutical product changes ownership, gets new packaging, or just hasn’t had a price increase in a long time.

Recently named FDA Commissioner Scott Gottlieb, MD, has made increasing generic competition a core mission. Plans include publishing lists of off-patent drugs made by one manufacturer and preventing brand-name drugmakers from using anticompetitive tactics to stave off competition.

Doctors, pharmacists, and patients don’t always receive warning when a price hike is about to occur, Dr. Fox said.

“Sometimes, we will get notices. Other times, it’s like a bad surprise,” she said, adding that the amount of wiggle room for alternatives depends on the drug and the patient.

Following some price hikes, doctors can use fewer units of a drug or switch it out entirely, she said.

Ofloxacin otic, long used to treat swimmer’s ear, became so expensive when generic manufacturers exited the market that doctors started using eye drops in patients’ ears, Dr. Fox said.

When old drugs get more expensive, hospitals try to eliminate waste by making smaller infusion bags and keeping really expensive drugs in the pharmacy instead of stocked in readily available shelves and drawers. But that’s not always possible.

“These drugs do have a place in daily therapy. Sometimes they’re life-sustaining and sometimes they’re lifesaving,” said Michael O’Neal, a pharmacist at Vanderbilt University Medical Center, Nashville, Tenn. “In this case, you just need to take it on the chin, and you hope one day for competition.”



KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Eight pharmaceutical companies more than doubled their lobbying spending in the first three months of 2017, when the Affordable Care Act was on the chopping block and high drug prices were clearly in the crosshairs of Congress and President Donald Trump.

Congressional records show that those eight, including Celgene and Mylan, kicked in an extra $4.42 million versus that quarter last year. Industry giant Teva Pharmaceutical Industries spent $2.67 million, up 115% from a year ago as several companies embroiled in controversies raised their outlays significantly.

“It’s certainly a rare event” when lobbying dollars double, noted Timothy LaPira, PhD, an associate professor of political science at James Madison University. “These spikes are usually timed when Congress in particular is going to be really hammering home on a particular issue. Right now, that’s health care and taxes.”

Trump has come down hard on drugmakers, stating in a press conference before his inauguration that the industry is “getting away with murder.” He has promised to lower drug prices and increase competition with faster approvals and fewer regulations. Sen. Bernie Sanders (I-Vt.), Sen. John McCain (R-Ariz.), and Rep. Elijah E. Cummings (D-Md.) have introduced bills to allow lower-cost drug imports from Canada or other countries.

Lobbyists weren’t expecting much by way of big policy changes during the comparatively sleepy end of the Obama administration this time last year, but, with a surprise Trump administration and a Republican-controlled House and Senate, trade groups and companies are probably “going all in,” Dr. LaPira said.

Thirty-eight major drugmakers and trade groups spent a total of $50.9 million, up $10.1 million from the first quarter of last year, according to a Kaiser Health News analysis. They deployed 600 lobbyists in all.

PhRMA, the drug industry’s largest trade group, spent $7.98 million during the quarter – more than in any single quarter in almost a decade, congressional records show, topping even its quarterly lobbying ahead of the Affordable Care Act’s passage in 2010.

In their congressional disclosures, companies listed Medicare price negotiation, the American Health Care Act, drug importation, and the orphan drug program as issues they were lobbying for or against. They do not have to disclose on which side of an issue they lobbied.

When Medicare prices are on the table, it should come as no surprise that pharmaceutical companies are interested in influencing congress.

“It’s quite literally hitting their bottom line,” LaPira said.

Drugmakers, under fire, more than doubled their lobbying dollars. Mylan spent $1.45 million during the quarter, up from $610,000 last year. The company’s CEO faced a congressional hearing in the fall when it raised the price of EpiPen to over $600.

Marathon Pharmaceuticals spent $230,000, which was $120,000 more than last year. Marathon was criticized in February after setting the price of Emflaza, a steroid to treat Duchenne muscular dystrophy, at $89,000 a year. That angered advocates, Congress, and patients who had been importing the same drug for as little as $1,000 a year. Marathon has since sold the drug to another company, and the price may come down.

Teva and Shire also more than doubled their spending. Teva was accused, as part of an alleged generic price-fixing scheme in December, and the Federal Trade Commission sued Shire because one of its recently acquired companies allegedly filed “sham” petitions with the Food and Drug Administration to stave off generics.

Companies that make drugs for rare diseases also more than doubled lobbying dollars as congressional leaders and the Government Accountability Office work to determine whether the Orphan Drug Act is being abused. Those firms include BioMarin, Celgene, and Vertex Pharmaceuticals. Celgene, which makes a rare cancer drug, more than tripled its first quarter lobbying to more than $1 million.

Despite efforts to make good on campaign promises to repeal the Affordable Care Act, House Republicans canceled a floor vote on the American Health Care Act in March after multiple studies estimated that millions of people would lose coverage if it passed, and neither Democrats nor ultraconservatives lined up in opposition to the bill’s provisions. Drug prices weren’t a key part of the package.
 

KHN’s coverage of prescription drug development, costs, and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Eight pharmaceutical companies more than doubled their lobbying spending in the first three months of 2017, when the Affordable Care Act was on the chopping block and high drug prices were clearly in the crosshairs of Congress and President Donald Trump.

Congressional records show that those eight, including Celgene and Mylan, kicked in an extra $4.42 million versus that quarter last year. Industry giant Teva Pharmaceutical Industries spent $2.67 million, up 115% from a year ago as several companies embroiled in controversies raised their outlays significantly.

“It’s certainly a rare event” when lobbying dollars double, noted Timothy LaPira, PhD, an associate professor of political science at James Madison University. “These spikes are usually timed when Congress in particular is going to be really hammering home on a particular issue. Right now, that’s health care and taxes.”

Trump has come down hard on drugmakers, stating in a press conference before his inauguration that the industry is “getting away with murder.” He has promised to lower drug prices and increase competition with faster approvals and fewer regulations. Sen. Bernie Sanders (I-Vt.), Sen. John McCain (R-Ariz.), and Rep. Elijah E. Cummings (D-Md.) have introduced bills to allow lower-cost drug imports from Canada or other countries.

Lobbyists weren’t expecting much by way of big policy changes during the comparatively sleepy end of the Obama administration this time last year, but, with a surprise Trump administration and a Republican-controlled House and Senate, trade groups and companies are probably “going all in,” Dr. LaPira said.

Thirty-eight major drugmakers and trade groups spent a total of $50.9 million, up $10.1 million from the first quarter of last year, according to a Kaiser Health News analysis. They deployed 600 lobbyists in all.

PhRMA, the drug industry’s largest trade group, spent $7.98 million during the quarter – more than in any single quarter in almost a decade, congressional records show, topping even its quarterly lobbying ahead of the Affordable Care Act’s passage in 2010.

In their congressional disclosures, companies listed Medicare price negotiation, the American Health Care Act, drug importation, and the orphan drug program as issues they were lobbying for or against. They do not have to disclose on which side of an issue they lobbied.

When Medicare prices are on the table, it should come as no surprise that pharmaceutical companies are interested in influencing congress.

“It’s quite literally hitting their bottom line,” LaPira said.

Drugmakers, under fire, more than doubled their lobbying dollars. Mylan spent $1.45 million during the quarter, up from $610,000 last year. The company’s CEO faced a congressional hearing in the fall when it raised the price of EpiPen to over $600.

Marathon Pharmaceuticals spent $230,000, which was $120,000 more than last year. Marathon was criticized in February after setting the price of Emflaza, a steroid to treat Duchenne muscular dystrophy, at $89,000 a year. That angered advocates, Congress, and patients who had been importing the same drug for as little as $1,000 a year. Marathon has since sold the drug to another company, and the price may come down.

Teva and Shire also more than doubled their spending. Teva was accused, as part of an alleged generic price-fixing scheme in December, and the Federal Trade Commission sued Shire because one of its recently acquired companies allegedly filed “sham” petitions with the Food and Drug Administration to stave off generics.

Companies that make drugs for rare diseases also more than doubled lobbying dollars as congressional leaders and the Government Accountability Office work to determine whether the Orphan Drug Act is being abused. Those firms include BioMarin, Celgene, and Vertex Pharmaceuticals. Celgene, which makes a rare cancer drug, more than tripled its first quarter lobbying to more than $1 million.

Despite efforts to make good on campaign promises to repeal the Affordable Care Act, House Republicans canceled a floor vote on the American Health Care Act in March after multiple studies estimated that millions of people would lose coverage if it passed, and neither Democrats nor ultraconservatives lined up in opposition to the bill’s provisions. Drug prices weren’t a key part of the package.
 

KHN’s coverage of prescription drug development, costs, and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Eight pharmaceutical companies more than doubled their lobbying spending in the first three months of 2017, when the Affordable Care Act was on the chopping block and high drug prices were clearly in the crosshairs of Congress and President Donald Trump.

Congressional records show that those eight, including Celgene and Mylan, kicked in an extra $4.42 million versus that quarter last year. Industry giant Teva Pharmaceutical Industries spent $2.67 million, up 115% from a year ago as several companies embroiled in controversies raised their outlays significantly.

“It’s certainly a rare event” when lobbying dollars double, noted Timothy LaPira, PhD, an associate professor of political science at James Madison University. “These spikes are usually timed when Congress in particular is going to be really hammering home on a particular issue. Right now, that’s health care and taxes.”

Trump has come down hard on drugmakers, stating in a press conference before his inauguration that the industry is “getting away with murder.” He has promised to lower drug prices and increase competition with faster approvals and fewer regulations. Sen. Bernie Sanders (I-Vt.), Sen. John McCain (R-Ariz.), and Rep. Elijah E. Cummings (D-Md.) have introduced bills to allow lower-cost drug imports from Canada or other countries.

Lobbyists weren’t expecting much by way of big policy changes during the comparatively sleepy end of the Obama administration this time last year, but, with a surprise Trump administration and a Republican-controlled House and Senate, trade groups and companies are probably “going all in,” Dr. LaPira said.

Thirty-eight major drugmakers and trade groups spent a total of $50.9 million, up $10.1 million from the first quarter of last year, according to a Kaiser Health News analysis. They deployed 600 lobbyists in all.

PhRMA, the drug industry’s largest trade group, spent $7.98 million during the quarter – more than in any single quarter in almost a decade, congressional records show, topping even its quarterly lobbying ahead of the Affordable Care Act’s passage in 2010.

In their congressional disclosures, companies listed Medicare price negotiation, the American Health Care Act, drug importation, and the orphan drug program as issues they were lobbying for or against. They do not have to disclose on which side of an issue they lobbied.

When Medicare prices are on the table, it should come as no surprise that pharmaceutical companies are interested in influencing congress.

“It’s quite literally hitting their bottom line,” LaPira said.

Drugmakers, under fire, more than doubled their lobbying dollars. Mylan spent $1.45 million during the quarter, up from $610,000 last year. The company’s CEO faced a congressional hearing in the fall when it raised the price of EpiPen to over $600.

Marathon Pharmaceuticals spent $230,000, which was $120,000 more than last year. Marathon was criticized in February after setting the price of Emflaza, a steroid to treat Duchenne muscular dystrophy, at $89,000 a year. That angered advocates, Congress, and patients who had been importing the same drug for as little as $1,000 a year. Marathon has since sold the drug to another company, and the price may come down.

Teva and Shire also more than doubled their spending. Teva was accused, as part of an alleged generic price-fixing scheme in December, and the Federal Trade Commission sued Shire because one of its recently acquired companies allegedly filed “sham” petitions with the Food and Drug Administration to stave off generics.

Companies that make drugs for rare diseases also more than doubled lobbying dollars as congressional leaders and the Government Accountability Office work to determine whether the Orphan Drug Act is being abused. Those firms include BioMarin, Celgene, and Vertex Pharmaceuticals. Celgene, which makes a rare cancer drug, more than tripled its first quarter lobbying to more than $1 million.

Despite efforts to make good on campaign promises to repeal the Affordable Care Act, House Republicans canceled a floor vote on the American Health Care Act in March after multiple studies estimated that millions of people would lose coverage if it passed, and neither Democrats nor ultraconservatives lined up in opposition to the bill’s provisions. Drug prices weren’t a key part of the package.
 

KHN’s coverage of prescription drug development, costs, and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

President Donald Trump’s pick to lead the Food and Drug Administration has deep ties to the pharmaceutical industry as a consultant, investor, and board member. Scott Gottlieb, MD, 44, also has worn many hats in a career that included two previous stints at the FDA, practicing as a physician, and writer/editor roles at prestigious medical journals.

“It seems like the main question is, ‘Which Gottlieb are we going to get?’” said Dr. Robert Califf, who stepped down from his position as the commissioner of the Food and Drug Administration in January.

Here’s a look at Dr. Gottlieb’s career, by the numbers:

188 companies

New Enterprise Associates, the venture capital firm in which Dr. Gottlieb is a partner, is currently or has been invested in 188 health care companies.

8 boards of directors

Dr. Gottlieb serves or has served on eight boards of directors, according to his LinkedIn profile. The firms include pharmaceutical companies Gradalis and Tolero Pharmaceuticals, which are developing cancer treatments, among other things; and Glytec, which offers glycemic management tools for patients with diabetes.

8 drug and device companies

Eight pharmaceutical companies disclosed payments to Dr. Gottlieb in 2015, according to the open payments database: Vertex Pharmaceuticals, GlaxoSmithKline, Daiichi, Valeant, Pfizer, Millennium, SI-BONE, and E.R. Squibb & Sons. Payments included travel to Philadelphia, San Francisco, and London.

9 recusals

In a memo, Dr. Gottlieb wrote that he had a consulting relationship with nine health care companies before his stint as the FDA’s deputy commissioner for medical and scientific affairs during the George W. Bush administration. Those ties disqualified him from dealing with matters concerning those companies for at least a year. The firms included Eli Lilly, Roche, and Sanofi-Aventis.

The recusals generated some headlines during the avian flu scare because Dr. Gottlieb had to recuse himself from some of the planning efforts around vaccines.

7 years

Starting in 1997, Dr. Gottlieb spent 7 years as a staff writer for BMJ, one of the top medical journals in the world. And he was an editor at the Pulse section of JAMA, the Journal of the American Medical Association, from 1996 to 2001.

Dr. Gottlieb also spent the past 7 years as an adviser to drug maker GlaxoSmithKline’s product investment board, according to his LinkedIn page.

33 years old

Dr. Gottlieb was 33 when he got the No. 2 job at the FDA in 2005. He had done a short stint at the agency a few years earlier but was considered a controversial pick because of his ties to Wall Street. He stayed until 2007.

“He has done a lot of thinking about how FDA should be managed – his operational sophistication is going to be a great asset,” said former FDA attorney Coleen Klasmeier, who worked with Dr. Gottlieb and coauthored articles with him. “He also has very strong relationships among career FDA personnel and will be able to hit the ground running on a range of important initiatives.”

18 times before Congress

Dr. Gottlieb testified before Congress as an expert witness 18 times. He has spoken about drug prices, revamping the FDA approval process and the vaccine supply.

“Most people watching at the FDA would breathe a sigh of relief,” Joshua Sharfstein, MD, who served as the FDA’s principal deputy commissioner until 2011, said of Dr. Gottlieb’s impending nomination. He added that Dr. Gottlieb is “not someone who has expressed antagonism to the core principles of the agency.”

36,000 Twitter followers

More than 36,000 people follow Dr. Gottlieb on Twitter, although he follows only 845 people, as of Tuesday. He has tweeted at least 10,400 times, lately about different strains of the flu.

72 percent

Almost three-fourths of the 53 drug companies surveyed by Mizuho said they’d prefer Dr. Gottlieb to head the FDA.

$414,000

Pharmaceutical companies paid Dr. Gottlieb nearly $414,000 from 2013 through 2015, according to federal open payments data, for speeches, consulting, travel, and meals.

That included $65,780 from a pharmaceutical company to promote a controversial cystic fibrosis drug called Kalydeco (ivacaftor). Only one other doctor received more money toward promoting the drug.

The drug’s price tag was controversial because the nonprofit Cystic Fibrosis Foundation kicked in $150 million toward finding a cure for the fatal disease and got a rich $3.3 billion payday for selling its rights to royalties for the drug. Vertex Pharmaceuticals priced Kalydeco at more than $300,000 a year.

Nearly $30,000

Dr. Gottlieb has contributed nearly $30,000 toward Republican political campaigns and joint fundraising committees from 2005 to 2014. He has donated toward the presidential runs of Mitt Romney and Sen. John McCain. He also donated more than once to Speaker Paul Ryan.

Dr. Gottlieb contributed the most money toward Sen. Ben Sasse (R-Neb.), spending $2,600 in the primary and $2,600 again in the general election in 2013. Sen. Sasse was a vocal anti-Trump supporter, penning an open letter in February 2016 about how he could not support Trump, who was “dividing” the nation, in his view.

“But have you noticed how Mr. Trump uses the word ‘Reign’ – like he thinks he’s running for King?” Sen. Sasse asked in the post.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

President Donald Trump’s pick to lead the Food and Drug Administration has deep ties to the pharmaceutical industry as a consultant, investor, and board member. Scott Gottlieb, MD, 44, also has worn many hats in a career that included two previous stints at the FDA, practicing as a physician, and writer/editor roles at prestigious medical journals.

“It seems like the main question is, ‘Which Gottlieb are we going to get?’” said Dr. Robert Califf, who stepped down from his position as the commissioner of the Food and Drug Administration in January.

Here’s a look at Dr. Gottlieb’s career, by the numbers:

188 companies

New Enterprise Associates, the venture capital firm in which Dr. Gottlieb is a partner, is currently or has been invested in 188 health care companies.

8 boards of directors

Dr. Gottlieb serves or has served on eight boards of directors, according to his LinkedIn profile. The firms include pharmaceutical companies Gradalis and Tolero Pharmaceuticals, which are developing cancer treatments, among other things; and Glytec, which offers glycemic management tools for patients with diabetes.

8 drug and device companies

Eight pharmaceutical companies disclosed payments to Dr. Gottlieb in 2015, according to the open payments database: Vertex Pharmaceuticals, GlaxoSmithKline, Daiichi, Valeant, Pfizer, Millennium, SI-BONE, and E.R. Squibb & Sons. Payments included travel to Philadelphia, San Francisco, and London.

9 recusals

In a memo, Dr. Gottlieb wrote that he had a consulting relationship with nine health care companies before his stint as the FDA’s deputy commissioner for medical and scientific affairs during the George W. Bush administration. Those ties disqualified him from dealing with matters concerning those companies for at least a year. The firms included Eli Lilly, Roche, and Sanofi-Aventis.

The recusals generated some headlines during the avian flu scare because Dr. Gottlieb had to recuse himself from some of the planning efforts around vaccines.

7 years

Starting in 1997, Dr. Gottlieb spent 7 years as a staff writer for BMJ, one of the top medical journals in the world. And he was an editor at the Pulse section of JAMA, the Journal of the American Medical Association, from 1996 to 2001.

Dr. Gottlieb also spent the past 7 years as an adviser to drug maker GlaxoSmithKline’s product investment board, according to his LinkedIn page.

33 years old

Dr. Gottlieb was 33 when he got the No. 2 job at the FDA in 2005. He had done a short stint at the agency a few years earlier but was considered a controversial pick because of his ties to Wall Street. He stayed until 2007.

“He has done a lot of thinking about how FDA should be managed – his operational sophistication is going to be a great asset,” said former FDA attorney Coleen Klasmeier, who worked with Dr. Gottlieb and coauthored articles with him. “He also has very strong relationships among career FDA personnel and will be able to hit the ground running on a range of important initiatives.”

18 times before Congress

Dr. Gottlieb testified before Congress as an expert witness 18 times. He has spoken about drug prices, revamping the FDA approval process and the vaccine supply.

“Most people watching at the FDA would breathe a sigh of relief,” Joshua Sharfstein, MD, who served as the FDA’s principal deputy commissioner until 2011, said of Dr. Gottlieb’s impending nomination. He added that Dr. Gottlieb is “not someone who has expressed antagonism to the core principles of the agency.”

36,000 Twitter followers

More than 36,000 people follow Dr. Gottlieb on Twitter, although he follows only 845 people, as of Tuesday. He has tweeted at least 10,400 times, lately about different strains of the flu.

72 percent

Almost three-fourths of the 53 drug companies surveyed by Mizuho said they’d prefer Dr. Gottlieb to head the FDA.

$414,000

Pharmaceutical companies paid Dr. Gottlieb nearly $414,000 from 2013 through 2015, according to federal open payments data, for speeches, consulting, travel, and meals.

That included $65,780 from a pharmaceutical company to promote a controversial cystic fibrosis drug called Kalydeco (ivacaftor). Only one other doctor received more money toward promoting the drug.

The drug’s price tag was controversial because the nonprofit Cystic Fibrosis Foundation kicked in $150 million toward finding a cure for the fatal disease and got a rich $3.3 billion payday for selling its rights to royalties for the drug. Vertex Pharmaceuticals priced Kalydeco at more than $300,000 a year.

Nearly $30,000

Dr. Gottlieb has contributed nearly $30,000 toward Republican political campaigns and joint fundraising committees from 2005 to 2014. He has donated toward the presidential runs of Mitt Romney and Sen. John McCain. He also donated more than once to Speaker Paul Ryan.

Dr. Gottlieb contributed the most money toward Sen. Ben Sasse (R-Neb.), spending $2,600 in the primary and $2,600 again in the general election in 2013. Sen. Sasse was a vocal anti-Trump supporter, penning an open letter in February 2016 about how he could not support Trump, who was “dividing” the nation, in his view.

“But have you noticed how Mr. Trump uses the word ‘Reign’ – like he thinks he’s running for King?” Sen. Sasse asked in the post.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

President Donald Trump’s pick to lead the Food and Drug Administration has deep ties to the pharmaceutical industry as a consultant, investor, and board member. Scott Gottlieb, MD, 44, also has worn many hats in a career that included two previous stints at the FDA, practicing as a physician, and writer/editor roles at prestigious medical journals.

“It seems like the main question is, ‘Which Gottlieb are we going to get?’” said Dr. Robert Califf, who stepped down from his position as the commissioner of the Food and Drug Administration in January.

Here’s a look at Dr. Gottlieb’s career, by the numbers:

188 companies

New Enterprise Associates, the venture capital firm in which Dr. Gottlieb is a partner, is currently or has been invested in 188 health care companies.

8 boards of directors

Dr. Gottlieb serves or has served on eight boards of directors, according to his LinkedIn profile. The firms include pharmaceutical companies Gradalis and Tolero Pharmaceuticals, which are developing cancer treatments, among other things; and Glytec, which offers glycemic management tools for patients with diabetes.

8 drug and device companies

Eight pharmaceutical companies disclosed payments to Dr. Gottlieb in 2015, according to the open payments database: Vertex Pharmaceuticals, GlaxoSmithKline, Daiichi, Valeant, Pfizer, Millennium, SI-BONE, and E.R. Squibb & Sons. Payments included travel to Philadelphia, San Francisco, and London.

9 recusals

In a memo, Dr. Gottlieb wrote that he had a consulting relationship with nine health care companies before his stint as the FDA’s deputy commissioner for medical and scientific affairs during the George W. Bush administration. Those ties disqualified him from dealing with matters concerning those companies for at least a year. The firms included Eli Lilly, Roche, and Sanofi-Aventis.

The recusals generated some headlines during the avian flu scare because Dr. Gottlieb had to recuse himself from some of the planning efforts around vaccines.

7 years

Starting in 1997, Dr. Gottlieb spent 7 years as a staff writer for BMJ, one of the top medical journals in the world. And he was an editor at the Pulse section of JAMA, the Journal of the American Medical Association, from 1996 to 2001.

Dr. Gottlieb also spent the past 7 years as an adviser to drug maker GlaxoSmithKline’s product investment board, according to his LinkedIn page.

33 years old

Dr. Gottlieb was 33 when he got the No. 2 job at the FDA in 2005. He had done a short stint at the agency a few years earlier but was considered a controversial pick because of his ties to Wall Street. He stayed until 2007.

“He has done a lot of thinking about how FDA should be managed – his operational sophistication is going to be a great asset,” said former FDA attorney Coleen Klasmeier, who worked with Dr. Gottlieb and coauthored articles with him. “He also has very strong relationships among career FDA personnel and will be able to hit the ground running on a range of important initiatives.”

18 times before Congress

Dr. Gottlieb testified before Congress as an expert witness 18 times. He has spoken about drug prices, revamping the FDA approval process and the vaccine supply.

“Most people watching at the FDA would breathe a sigh of relief,” Joshua Sharfstein, MD, who served as the FDA’s principal deputy commissioner until 2011, said of Dr. Gottlieb’s impending nomination. He added that Dr. Gottlieb is “not someone who has expressed antagonism to the core principles of the agency.”

36,000 Twitter followers

More than 36,000 people follow Dr. Gottlieb on Twitter, although he follows only 845 people, as of Tuesday. He has tweeted at least 10,400 times, lately about different strains of the flu.

72 percent

Almost three-fourths of the 53 drug companies surveyed by Mizuho said they’d prefer Dr. Gottlieb to head the FDA.

$414,000

Pharmaceutical companies paid Dr. Gottlieb nearly $414,000 from 2013 through 2015, according to federal open payments data, for speeches, consulting, travel, and meals.

That included $65,780 from a pharmaceutical company to promote a controversial cystic fibrosis drug called Kalydeco (ivacaftor). Only one other doctor received more money toward promoting the drug.

The drug’s price tag was controversial because the nonprofit Cystic Fibrosis Foundation kicked in $150 million toward finding a cure for the fatal disease and got a rich $3.3 billion payday for selling its rights to royalties for the drug. Vertex Pharmaceuticals priced Kalydeco at more than $300,000 a year.

Nearly $30,000

Dr. Gottlieb has contributed nearly $30,000 toward Republican political campaigns and joint fundraising committees from 2005 to 2014. He has donated toward the presidential runs of Mitt Romney and Sen. John McCain. He also donated more than once to Speaker Paul Ryan.

Dr. Gottlieb contributed the most money toward Sen. Ben Sasse (R-Neb.), spending $2,600 in the primary and $2,600 again in the general election in 2013. Sen. Sasse was a vocal anti-Trump supporter, penning an open letter in February 2016 about how he could not support Trump, who was “dividing” the nation, in his view.

“But have you noticed how Mr. Trump uses the word ‘Reign’ – like he thinks he’s running for King?” Sen. Sasse asked in the post.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.