THE PROGNOSIS

In the more than two months since President Trump stood in the Rose Garden and made big promises about lowering drug prices, the most significant steps taken have come from an agency with no official role in how those prices are set.

Ever since Scott Gottlieb took over the Food and Drug Administration, he's viewed the agency's mission as including not only approving new drugs, but also ensuring Americans can actually get their medicine. 

So Tuesday, Gottlieb offered yet another idea for how to do that: Make more commonly prescribed drugs available over the counter. Doing so, he said in a statement, will make medicines more accessible to patients and potentially lower costs.

"While the FDA doesn’t have a direct role in the cost of medicines, we’re very mindful of the time and financial cost to patients and the health care system to fill a prescription medicine – particularly one taken repeatedly for chronic conditions," Gottlieb said.

The FDA this year has been at the forefront of the wide-ranging debate over the rising cost of drugs. It's a problem congressional Republicans and Democrats, as well as the Trump White House, agree is unsustainable and needs to be addressed. But, like so many issues requiring Washington to act, there seems to be little political will to tackle the thornier problems that would make the biggest difference. Incremental change is more likely.

In the absence of substantial change, such as allowing the government to negotiate directly with drug companies on pricing, the FDA is considering policies within its purview, including promoting competition in the marketplace. In May, the FDA published a list of brand drug companies on its website that it suspected of intentionally blocking other companies from making generics of their products. The development of generic drugs is what often drives down costs. 

Gottlieb famously (among those who follow these things) said it was time to "end the shenanigans" by drug companies that limit competition. He also wants his agency to accelerate approval of genetic drugs. 

Congress has also homed in on this specific issue. In February, The Health 202's own Paige Winfield Cunningham wrote about the wide bipartisan support for the CREATES Act, a bill that would crack down on drug companies' delay tactics to prevent generic-making companies from getting samples they need to develop their versions. One would be hard pressed to find legislation supported by conservatives like Sens. Ted Cruz of Texas and Mike Lee of Utah and liberal like Sens. Dianne Feinstein of California and Sheldon Whitehouse of Rhode Island, and yet those strange bedfellows are all co-sponsors of the bill. The Senate Judiciary Committee passed it in June. 

It shouldn't be a surprise that big drugmakers are not fans of the bill, yet on Tuesday, during an event on the state of health care hosted by The Atlantic, Eli Lilly and Company CEO Dave Ricks said his pharmaceutical company has never sought to restrict generics, and supports the CREATES Act. (Remember that Health and Human Services chief Alex Azar is a former top Eli Lilly executive):

 

Still, Trump, who campaigned for president on lowering drug costs and vowed to come down hard on drugmakers, backed away from his populist promise to use Medicare's economic power to negotiate lower prices for seniors. In an opinion piece written by the New York Times editorial board published Tuesday night, the editors argue that Trump's tough talk on drug prices is just that: talk. "In fact, if the industry is 'getting away with murder,' as Mr. Trump once claimed, it stands to reason that at this point, it’s doing it with the president’s help," they wrote. 

They noted that when Trump announced his 44-page list of ideas in May for lowering drug costs he predicted the large drug manufacturers were going to start voluntarily cutting prices. And yet, they didn't. The closest the president has come to achieving that goal was last month, when Pfizer announced more drug price hikes. Trump publicly shamed the company on Twitter and then privately spoke to executives, and they agreed to back down for six months or until the administration finalized its drug prices plan. 

But no one knows what Trump offered to get that concession. Sen. Tammy Baldwin (D-Wis.) wrote a letter to Pfizer CEO Ian Read on Monday seeking more information around the company's decision to roll back the prices. 

"Your announcement to temporarily defer this latest round of price hikes calls into question your actions to raise prices in the first place and provides no answers to consumers about whether this will help them better afford their medication now and in the long-run," she wrote. "Your apparent agreement with President Trump is exactly why we need transparency and accountability."

Swiss pharmaceutical giant Novartis also announced Tuesday it wouldn't be increasing prices for the rest of 2018, a decision that Trump could tout as a success.  CEO Vas Narasimhan said he did not have a direct conversation with the president about drug prices, but had been in contact with The Department of Health and Human Services regarding the administration's plans, according to Reuters’s John Miller.

Notably, Tuesday was also the end of the comment period on President Trump's drug prices blueprint, and now it's on the administration to weigh the thousands of opinions filed from industry and the public and then start implementing its ideas through regulations or pushing for them through legislation. 

With so many moving pieces in this debate, we reached out to Ropes & Gray health-care partner Tom Bulleit to determine whether any of the ideas will make a real difference in what Americans pay for their medications. 

Bulleit was extremely dubious. 

"Everybody says, 'we acknowledge drug prices are too high,' but there’s no political consensus on how to do anything big about it," he told me. "There’s a lot of tinkering around the edges, I don’t see any of this having any significant effect on drug prices."

And as for the actions over at the FDA, Bulleit predicts the impact will be marginal at best. 

"My cynical answer to that is they're throwing everything at the wall to see what sticks and this is another thing the administration wants to be able to say it’s doing that might have an effect though the chance it will impact a significant number of consumers is low," he said. "They want to get credit for doing something about drug prices, but I’m not sure this is any more than talk in terms of the results."

AHH, OOF and OUCH

AHH: The migrant crisis is costing HHS millions of dollars it would normally spend on public health programs and medical research.

Since the Trump administration started separating children and their parents at the border under its “zero-tolerance" policy, HHS has been responsible for caring for the kids in agency-run shelters. After Trump ended the separations, HHS has been responsible for reuniting the families. So far, this has cost the agency at least $40 million, Politico reports.

“We have a public health emergency like Ebola, Zika, hurricanes --- except this one is man-made,” Emily Holubowich, executive director of the Coalation for Health Funding, told Politico’s Dan Diamond. “We should not be taking discretionary funding away from programs that need it.”

OOF: There has been a marked increase in the number of drugs given the “breakthrough” designation by federal regulators since they began doing so in 2012. But a new study finds many of these therapies lack strong medical evidence to prove whether they’re effective.

The study published in the Journal of American Medical Association examined the FDAs approval over the last six years of so-called “breakthrough” drugs, which are expedited for serious diseases when preliminary evidence suggests they will be more effective than existing treatments, The Post’s Carolyn Y. Johnson reports.

The Yale School of Medicine study found 40 percent of the approved drugs used no randomized trials and it also found nearly half of trials for approved “breakthrough” drugs also did not include a placebo, and patients or physicians were aware of who was getting the drug and who was not, Carolyn reports. Shorter and less comprehensive trials, she notes, can also mean more uncertainty about the drug overall.

Joseph Ross, associate professor of medicine at Yale said if a trade-off is made making the “breakthrough” drugs more uncertain “we must be committed as a clinical and scientific community to ensuring that high-quality, rigorous post-market trials are conducted within a reasonable period.”

OUCH: The Republican-led states that are targeting the Affordable Care Act with lawsuits are the same states that would suffer the most without protections for individuals with preexisting conditions, Kaiser Health News’s Harriet Rowan reports.

Out of the 11 states with the highest rates of adults under 65 with preexisting conditions, there are nine that have signed onto a suit to challenge the ACA, Harriet reports, citing data from the CDC that has been analyzed by the Kaiser Family Foundation. West Virginia has the highest rate of people under 65 with preexisting conditions at 36 percent.

“Before the health law was adopted, insurance companies routinely denied coverage to millions of people with preexisting conditions who purchased insurance through the individual marketplace,” Harriet writes. “If they didn’t deny coverage outright, some health plans charged consumers exorbitant premiums, or offered policies that excluded coverage for pricey conditions.”

Harriet adds: “The KFF analysis estimated that at least 27 percent of adults under 65 — more than 50 million Americans — had at least one preexisting condition that would have jeopardized their coverage pre-ACA.”

AGENCY ALERT

— For Robert Redfield, the CDC director, his work to combat the opioid epidemic is personal.

“I almost lost one of my children from it,” Redfield said last week at a conference in New Orleans, according to the Associated Press. He said one of his children nearly died of an overdose of cocaine mixed with the potent synthetic opioid fentanyl.

Redfield expressed the difficulties of finding treatment for his son, the National Association of County and City Health Officials’s outgoing president Umair Shah told the AP.

In a statement to The Post’s Lindsey Bever and Lena H. Sun, Redfield followed up by saying it’s “important for society to embrace and support families who are fighting to win the battle of addiction – because stigma is the enemy of better health.”

— The FDA announced a voluntary recall of a valsartan, a generic blood pressure medication sold in the United States and imported from China. Three companies agreed to the recall, the New York Times’s Sheila Kaplan reports, after concerns of contamination during manufacturing by N-nitrosodimethylamine, a potential human carcinogen.

“All of the valsartan that is being recalled was made in China by the same company, Zhejiang Huahai Pharmaceutical Co. Ltd. It is distributed in the United States by three companies: Major Pharmaceuticals; Teva Pharmaceutical Industries, Ltd.; and Solco Healthcare,” Sheila reports.

Consumers can check the manufacturer name on the drug label, or contact the pharmacy where it was obtained, to figure out if its part of the recall. The agency is still investigating the possible contamination.

— FDA Commissioner Gottlieb mentioned at the Politico Pro Summit yesterday that the agency will look to suppress the labeling of nondairy almond, coconut and soy products as “milk.”

He said the FDA would release guidance soon related to its "standards of identity" policies related to the marketing of milk products, Politico’s Alexander Nieves reports. The agency would first gather public comments before moving forward on any change.

“In our standards of identity, there is a reference somewhere to a lactating animal and an almond doesn’t lactate, I will confess,” Gottlieb said during the summit. “So the question becomes about whether we’ve ben enforcing our own standards of identity. The answer is probably not.” 

Gottlieb added: "There are going to be people who make a counter-argument that almond milk should be able to call itself 'milk,' but we do have a standard of identity and I do intend to enforce that."

— Centers for Medicare and Medicaid Services Administrator Seema Verma said a federal judge’s ruling to stop work requirements for Medicaid beneficiaries in Kentucky won’t stop the agency from considering other states’ requests.

“We are very committed to this,” Verma said at the Politico summit yesterday. “We are looking at what the court said. We want to be respectful of the court’s decision while also wanting to push ahead with our policy initiatives and our goals. … We are trying to figure out a path forward.”

CMS is still considering waivers to add work requirements from Arizona, Maine, Utah and Wisconsin, per Politico’s Dan Goldberg, and has approved them for Arkansas, Indiana and New Hampshire. Michigan and Virginia are also expected to request to add work requirements to their programs.

— CMS is cutting off Medicare funding for heart transplants at the Baylor St. Luke’s Medical Center in Houston as a result of a markedly high rate of patient deaths, the Houston Chronicle’s Mike Hixenbaugh reports.

The hospital had until the end of the day yesterday to notify Medicare patients waiting for heart transplants that they should transfer to another hospital or lose the ability to bill Medicare for medical services starting in mid-August, according to a letter CMS sent the hospital.

“St. Luke’s can still appeal the ruling before an administrative law judge, but that would not stop the termination of funding next month,” Mike writes. “CMS first notified the hospital last month of the agency’s intention to terminate funding. The decision came just weeks after an investigation by the Houston Chronicle and ProPublica found that the program lost several top doctors and performed an outsized number of heart transplants resulting in deaths in recent years.”

And now, the renowned program may close all together. “Hospital leaders have not said whether they plan to shut down the program after Medicare funding ends, or if they will attempt to keep it going with depleted resources,” Mike writes. “Medicare’s action does not affect patients awaiting kidney, liver or lung transplants at St. Luke’s.”

HEALTH ON THE HILL

— Federal Reserve Chairman Jerome Powell warned Tuesday of the opioid epidemic’s effect on the nation’s economy.

"From an economic standpoint, some high percentage of prime-age people who are not in the labor force, particularly prime-age males who are not in the labor force, are taking painkillers of some kind," he said before the Senate Banking, Housing and Urban Affairs Committee.

He referred to Princeton economist Alan Krueger’s research that found 44 percent of men report taking painkillers the previous day. "It's a big number," Powell said, per CNBC’s Jeff Cox. "It's having a terrible human toll on our communities and also it matters a lot for the labor force participation rate and economic activity in our country."

MEDICAL MISSIVES

— The rate of death from liver cancer jumped 43 percent for American adults from 2000 to 2016, the Centers for Disease Control and Prevention said in a new report yesterday. The rate increased from 10.5 people per 100,000 to 15 for men and from 4.5 to 6.3 per 100,000 for women.

The death rate increased for white, black and Hispanic people, as well as for both men and women 25 and older, CNN’s Maddie Bender reports.

“More than 70% of liver cancers are caused by underlying liver disease, which has risk factors such as obesity, smoking, excess alcohol consumption, and hepatitis B and C infection,” Maddie writes, citing the American Cancer Society’s Farhad Islami, the scientific director of cancer surveillance research. Report author Jiaquan Xu said blood transfusions and organ transplants are one common cause of hepatitis C transmission, which can lead to liver cancer. Before 1992, such blood and organ donations were not screened for the disease.

The ongoing opioid crisis may also be a contributing factor, as needle sharing may lead to hepatitis C transmission, Maddie reports.

— And here are a few more good reads: 

After years of cost-cutting and closures, fewer than half of the nation’s rural counties now have a hospital that offers any obstetric care, researchers say.
The New York Times
INDUSTRY RX
Johnson & Johnson CEO Alex Gorsky called for changes in the way prescription drugs are paid for but stopped short of saying pharmaceutical companies need to lower the prices they charge.
CNBC
STATE SCAN
State-sponsored health insurance for all Marylanders such as the single-payer plan proposed by Democratic gubernatorial nominee Ben Jealous could cost $24 billion a year, forcing lawmakers to significantly raise taxes, according to a nonpartisan analysis.
Baltimore Sun
Maryland’s health care exchange has announced hearings for public comment on regulations to create a reinsurance program for the individual health insurance market.
Associated Press
REPRODUCTIVE WARS
Health & Science
FERTILITY FRONTIER | Critics decrying forced parentage say the Arizona law is an attack on personal freedom.
Ariana Eunjung Cha
BOISE, Idaho (AP) — Planned Parenthood of the Great Northwest and the Hawaiian Islands is suing the state of Idaho in federal court over new abortion reporting requirements that c
Associated Press
SECOND OPINION
PowerPost
Social Security advocates cite the negative affect of Trump’s actions on employee morale and the resulting impact on service.
Joe Davidson
DAYBOOK

Today

  • The Senate Special Committee on Aging holds a hearing on “Supporting Economic Stability and Self-Sufficiency as Americans with Disabilities and their Families Age."
  • Brookings Institution holds a event with FDA Commissioner Scott Gottlieb.
  • The FDA’s Blood Products Advisory Committee holds an open session.

Coming Up

  • The National Academies of Sciences, Engineering, and Medicine holds a workshop on the integration of health care and social services on Thursday.
  • The House Energy and Commerce Subcommittee on Health holds a hearing on “21st Century Cures Implementation: Examining Mental Health Initiatives” on Thursday.
  • The Alliance for Health Policy holds an event on “State Responses to the Evolving Individual Health Insurance Market” on Friday.
SUGAR RUSH
Here are some of Democrats' fractured arguments against Supreme Court nominee Brett Kavanaugh

Trump says he misspoke in Helsinki. Here's what he said, then and now: