Jayne O'Donnell, and Deirdre Shesgreen

USA TODAY

WASHINGTON — A new patient advocacy group launches Wednesday that distinguishes itself by focusing only on drug prices and eschewing money from the pharmaceutical industry at a time when drug makers are pouring millions into a campaign fighting efforts to regulate them.

The formation of Patients for Affordable Drugs (PFAD) comes as local officials and members of Congress are decrying the latest huge drug price hikes, this time by drugmaker Kaléo for its version of the overdose antidote naloxone.

A patient group fighting high drug prices might not seem so unusual unless you've experienced the issue professionally and personally, as PFAD founder David Mitchell has. He was diagnosed with the incurable blood cancer, multiple myeloma, six years ago and has consulted for Memorial Sloan Kettering Cancer Center's Center for Health Policy and Outcomes and the Institute for Clinical and Economic Review, which evaluates the value of drugs.

For five years, Mitchell was on Revlimid, which is the most expensive drug for Medicare patients with median annual out of pocket costs of $11,500, according to the Kaiser Family Foundation. His insurance with his former employer covered all but $3,000 of the annual cost, but he notes the average median annual income of Medicare patients is $24,150.

"Patient groups do a lot of good, important things, like patient education and patient support, but they’re not serving patients' interests by ignoring drug prices," said Mitchell.

Drug prices have become a bi-partisan hot button issue here with members of both parties sponsoring legislation. Tuesday, more than 70 Democratic House members wrote a letter to Kaléo demanding an explanation for its 600% increase in the price of its Evzio opioid overdose antidote. The request closely mirrored a letter sent earlier this month by 31 Senate Democrats.

“As members of Congress who have seen firsthand the toll the opioid epidemic has taken on our communities, we cannot sit idly by while life-saving naloxone is priced beyond reach of those that need it,” the letter stated.

Last year, lawmakers in Congress investigated several instances of skyrocketing drug prices, including over Turing Pharmaceuticals' Daraprim and Mylan's EpiPen.

Kaléo, which makes an injector device to deliver naloxone, increased the list price from $690 in 2014 to more than $4,000 today.

Sen. Claire McCaskill of Missouri, the top Democrat on the Homeland Security and Governmental Affairs Committee, signed the Senate letter to Kaléo and says she plans to use her committee role to probe drug price spikes.

“High drug prices and sudden price spikes have hurt Missouri families — some of whom are forced to choose between life-saving medicine and paying their bills,” McCaskill said in a statement.

Baltimore health commissioner Leana Wen, an emergency physician who has crusaded for increased access to naloxone, said Kaléo has donated about 20,000 doses of Evzio to the city to help save the lives of addicts. But she said that charity “is not a long -term solution.”

The generic form of naloxone has also increased, and Wen says she hasn't gotten answers about price hikes from the drug's manufacturers.

Kaléo says raising the price allowed it to offer Evzio to more people for no out-of-pocket costs. Critics say these programs shift the cost to others with commercial insurance.

Kaléo CEO Spencer Williamson said in a statement that the company has donated 200,000 naloxone auto-injectors to public health departments, first responders and non-profits and plans to donate about 100,000 more this year.

Williamson told the Detroit Free Press the listed wholesale price for distributors selling to pharmacies is $4,100 but it is "not a true net price to anyone, including the distributors or pharmacies, due to numerous discounts and rebates that are negotiated in the supply chain that make up our health care system."

Unlike with Turing or Mylan, the senators’ objectives are now supported by groups that actually represent the people most affected by the increases.

Williamson's explanation "is exactly why we need transparency in the drug pricing system," says Mitchell.

"They tell us the published price isn't the actual price," he says. "But they won't tell us the actual price, so how can we make decisions on policy and purchasing?"

Along with greater transparency, Mitchell's group wants Medicare to be able to negotiate lower costs for patients, something both Hillary Clinton and President Trump supported during the presidential campaign. It also favors setting prices based on the value drugs deliver to patients and speeding generic drug approval.



Read more:

Price of drug for overdoses jumps more than 600%

Patient groups funded by drugmakers are largely mum on high drug prices

Pharma trade group helps fund patient fight against Medicare project

Secret deals may mean consumers pay more for drugs

Mitchell's mission will be bolstered by an unlikely advocate. A coalition of about 100 patient groups plans to require by year's end more disclosure of funding by its members, including amounts — rather than ranges — of funding by company or percentages by industry sector, National Health Council CEO Marc Boutin told USA TODAY. Boutin says he expects many of the organizations will disclose both. The board of the health council, which gets about 60% of its funding from the pharmaceutical industry, will also vote soon on its first legislative proposal on health care costs, including drug prices. Like PFAD, it will push drug price transparency and faster approval of generic drugs.

"The media has been tough on patient organizations over the last year and a half," says Boutin. "But there has been an oversimplification. Having a relationship with a stakeholder doesn’t mean you always agree."

It did mean, however, that the groups didn't address drug prices, Mitchell charges

The pressure from legislators and patients comes as two industry groups have started their own advocacy campaigns. The drugmaker trade group, Pharmaceutical Research and Manufacturers of America, unveiled plans for a massive, multi-year advocacy campaign on the value of its drugs and said it will spend tens of millions of dollars a year for up to five years. A spokeswoman for PhRMA did not respond to messages seeking details of the PR blitz.

A bipartisan bill, introduced last year by Sens. John McCain, R-Ariz., and Tammy Baldwin, D-Wis., would require certain drug manufacturers to report any price increase of 10% or more, over a 12-month period, to the Department of Health and Human Services.

The Generic Pharmaceutical Association announced last week a new national effort to highlight its comparatively low drug costs and its role in keeping drug costs down. The group also changed its name to the Association for Accessible Medicines (AAM) and says wants to make sure it doesn’t get swept up in any crackdowns on Big Pharma.

AAM CEO Chip Davis said proposals such as the McCain-Baldwin bill could slam generic drug makers whose price increases are often pennies on the dollar compared to the big brand manufacturers.



"Both the president and many congressional leaders have said they believe one of the ways to constrain growing drug costs is to find ways to enhance more competition," he says, adding that presents opportunities for his industry.



Wen has been pushing for drug price transparency legislation at the state level in Maryland, and she said forcing drug companies to explain price hikes could go a long way toward curbing costs.

The new patient advocacy group could help bring more urgency and attention to the debate, she added.

"While it's one thing to hear public officials like me on the front lines talk about how this affects us," she says it’s another to hear from patients whose lives are at stake.

“Pharmaceutical companies have long influenced the prescribing practices of doctors,” Wen said. “When that practice got exposed … (drugmakers) turned to supporting patient groups under the guise that they are promoting awareness of a particular disease.”

In the last 18 months, Mitchell's wife and co-founder, Nicole, developed breast cancer and lost her 69-year-old mother to lung cancer. The family has the resources to pay for their health issues: Along with good health insurance, David is now on Medicare and they were even able to contribute $75,000 of their own money to launch PFAD. (The Laura and John Arnold Foundation contributed a grant of $500,000.)

PFAD is designed to help address soaring drug prices, which along with the uninsured and those with high out of pockets costs, affects taxpayers and even those who aren't on drugs but pay health premiums. It is seeking patients' stories and collecting email addresses in hopes of building a "community of patients to stand up for change."

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