Tagged Pharmaceuticals

House Dems Open Investigation Into Pharma’s Drug Pricing Strategies, Calling The Probe One Of The Broadest In Decades

House Oversight and Reform Committee Chairman Elijah Cummings sent letters to drugmakers requesting detailed information about their pricing practices, focusing on drugs that are the costliest to Medicare Part D as well as drugs that have had the largest increases over a five-year period. The move is just the latest in a flurry of legislation and congressional action taken on the topic of high drug prices this year.

Record On Big Pharma Hangs Over Cory Booker As He Readies For A 2020 Presidential Run

Sen. Cory Booker (D-N.J.) drew criticism when he voted against a budget amendment allowing for the importation of drugs. As he preps to enter the 2020 fray, he’s been taking steps to counter that line of attack by joining forces with Sen. Bernie Sanders (I-Vt.) on his legislation aimed at high drug prices.

Record On Big Pharma Hangs Over Cory Booker As He Readies For A 2020 Run

Sen. Cory Booker (D-N.J.) drew criticism when he voted against a budget amendment allowing for the importation of drugs. As he preps to enter the 2020 fray, he’s been taking steps to counter that line of attack by joining forces with Sen. Bernie Sanders (I-Vt.) on his legislation aimed at high drug prices.

Meth’s Resurgence Spotlights Lack Of Meds To Combat The Addiction

In 2016, news reports warned the public of an opioid epidemic gripping the nation.

But Madeline Vaughn, then a lead clinical intake coordinator at the Houston-based addiction treatment organization Council on Recovery, sensed something different was going on with the patients she checked in from the street.

Their behavior, marked by twitchy suspicion, a poor memory and the feeling that someone was following them, signaled that the people coming through the center’s doors were increasingly hooked on a different drug: methamphetamine.

“When you’re in the boots on the ground,” Vaughn said, “what you see may surprise you, because it’s not in the headlines.”

In the time since, it’s become increasingly clear that, even as the opioid epidemic continues, the toll of methamphetamine use, also known as meth or crystal meth, is on the rise, too.

The rate of overdose deaths involving the stimulant more than tripled from 2011 to 2016, the Centers for Disease Control and Prevention reported.

But unlike the opioid epidemic — for which medications exist to help combat addiction — medical providers have few such tools to help methamphetamine users survive and recover. A drug such as naloxone, which can reverse an opioid overdose, does not exist for meth. And there are no drugs approved by the Food and Drug Administration that can treat a meth addiction.

“We’re realizing that we don’t have everything we might wish we had to address these different kinds of drugs,” said Dr. Margaret Jarvis, a psychiatrist and distinguished fellow for the American Society of Addiction Medicine.

Meth revs up the human body, causing euphoria, elevated blood pressure and energy that enables users to go for days without sleeping or eating. In some cases, long-term use alters the user’s brain and causes psychotic symptoms that can take up to one year after the person has stopped using it to dissipate.

Overdosing can trigger heart attacks, strokes and seizures, which can make pinpointing the drug’s involvement difficult.

Meth users also tend to abuse other substances, which complicates first responders’ efforts to treat a patient in the event of an overdose, said Dr. David Persse, EMS physician director for Houston. With multiple drugs in a patient’s system, overdose symptoms may not neatly fit under the description for one substance.

“If we had five or six miracle drugs,” Persse said, to use immediately on the scene of the overdose, “it’s still gonna be difficult to know which one that patient needs.”

Research is underway to develop a medication that helps those with methamphetamine addiction overcome their condition. The National Institute on Drug Abuse Clinical Trials Network is testing a combination of naltrexone, a medication typically used to treat opioid and alcohol use disorders, and an antidepressant called bupropion.

And a team from the Universities of Kentucky and Arkansas created a molecule called lobeline that shows promise in blocking meth’s effects in the brain.

For now, though, existing treatments, such as the Matrix Model, a drug counseling technique, and contingency management, which offers patients incentives to stay away from drugs, are key options for what appears to be a meth resurgence, said Jarvis.

Illegal drugs never disappear from the street, she said. Their popularity waxes and wanes with demand. And as the demand for methamphetamine use increases, the gaps in treatment become more apparent.

Persse said he hasn’t seen a rise in the number of calls related to methamphetamine overdoses in his area. However, the death toll in Texas from meth now exceeds that of heroin.

Provisional death counts for 2017 showed methamphetamine claimed 813 lives in the Lone Star State. By comparison, 591 people died due to heroin.

The Drug Enforcement Administration reported that the price of meth is the lowest the agency has seen in years. It is increasingly available in the eastern region of the United States. Primary suppliers are Mexican drug cartels. And the meth on the streets is now more than 90 percent pure.

“The new methods [of making methamphetamine] have really altered the potency,” said Jane Maxwell, research professor at the University of Texas at Austin’s social work school. “So, the meth we’re looking at today is much more potent than it was 10 years ago.”

For Vaughn, who works as an outpatient therapist and treatment coordinator, these variables are a regular part of her daily challenge. So until the research arms her with something new, her go-to strategy is to use the available tools to tackle her patients’ methamphetamine addiction in layers.

She starts with writing assignments, then coping skills until they are capable of unpacking their trauma. Addiction is rarely the sole demon patients wrestle with, Vaughn said.

“Substance use is often a symptom for what’s really going on with someone,” she said.

Must-Reads Of The Week From Brianna Labuskes

Happy Friday, where we’re 20 days and so-and-so hours (depending on when you read this) into the partial federal shutdown. As of today, it’s tied as the second-longest one in U.S. history, matching the funding gap that stretched from December ’95-January ’96 under President Bill Clinton. (Side note: The history of U.S. shutdowns is a good read for us policy nerds.)

Although health care has been somewhat insulated from the standoff (because funding for the Department of Health and Human Services had already been approved), the battle is really a lesson in the power of a ripple effect. Among the health-related things that have been touched by the impasse in some way: the CVS-Aetna merger, domestic violence victims, food stampswildfire and storm disaster funding, pollution inspections, drug approvals and the Affordable Care Act lawsuit.

But a lot of focus this week was on how the shutdown is curtailing food safety inspections by the Food and Drug Administration, especially following a year that was marked by several high-profile foodborne illness outbreaks.

Politico: FDA Looks to Restart Safety Inspections for Risky Foods Amid Shutdown


This week, my pharma files in Morning Briefing were bursting at the seams, and to be honest, I don’t see that changing anytime soon. This is definitely going to be a year of drug-pricing news, especially because it’s one of the few bipartisan topics that Capitol Hill watchers say might gain traction in a divided Congress.

In recent days, that — along with the fact that drug prices are most certainly a winning election issue — was on stark display. Democratic hopefuls for 2020 are jostling at the starting line to be the one to get THE big, flashy pharma bill out, with Vermont Sen. Bernie Sanders (joined by fellow hopeful New Jersey Sen. Cory Booker and others) as the latest to announce a proposal.

Sanders’ bundle of bills includes allowing the importation of cheaper drugs from Canada, letting Medicare negotiate prices and stripping monopolies from drug companies if their prices exceed the average price in other wealthy countries.

One interesting thing to note (from Stat’s coverage) is that even potential candidates from states that have a heavy biopharma presence (like Massachusetts Sen. Elizabeth Warren and New Jersey’s Booker) are coming out swinging against the industry — a sure sign that being firmly against Big Pharma is seen as crucial to securing the Democratic nomination.

Stat: Democrats Eyeing 2020 Put an Early Spotlight on Drug Prices

The Hill: Sanders, Dems Unveil Sweeping Bills to Lower Drug Prices

The pharma action this week wasn’t limited to the Hill, because the movers and shakers in the industry were all thinking big thoughts at the annual J.P. Morgan Healthcare Conference. There, Johnson & Johnson CEO Alex Gorsky argued that drugmakers were going to have to step up their own self-policing when it comes to pricing or face “onerous” alternatives. Looking at the stories above, I’m thinking he’s not wrong.

The Wall Street Journal: Health-Care CEOs Outline Strategies at J.P. Morgan Conference

Meanwhile, health systems tired of shortages and high prices are flocking by the dozens to the fledgling nonprofit that was created by a group of hospitals to manufacture its own generic drugs.

Stat: Generic Drug Maker Formed by Hospitals Attracts a Dozen More Members

It was hard to pick just a few pharma stories this week, considering the abundance of choices, but one that you should absolutely make time to read is this insulin-rationing piece. Insulin has become the new face of public outrage against outrageous price increases, and this piece presents a good overview of how that came to be, as well as the human toll the hikes have taken. The gut-punch sentence: “Within a month of going off [his mother’s] policy, [Alec Raeshawn Smith] would be dead.”

The Washington Post: Insulin Is a Lifesaving Drug, But It Has Become Intolerably Expensive. and the Consequences Can Be Tragic.


In a largely symbolic move, House Democrats voted to intervene in the health care lawsuit — a strategy geared more toward putting Republicans on record voting against the law (and thus against popular provisions they promised in the midterms to protect) than anything else.

The Hill: Dems Hit GOP on Health Care With Additional ObamaCare Lawsuit Vote

The vote highlighted a problem the GOP faces as it eyes 2020: For the longest time, Republicans have fallen back on “repeal and replace” as their main health care message. Now, the party is going to have to come up with a “positive vision” if they want to regain ground with voters, experts say.

The Hill: GOP Seeks Health Care Reboot After 2018 Losses


States, states, states! Everyone says that’s where the health care movement will be in the next two years, which certainly held true this week.

In California, new Gov. Gavin Newsom revealed his big health care dreams that include reshaping how prescription drugs are paid for, taking steps toward a single-payer system, reinstating the individual mandate, expanding Medi-Cal coverage for immigrants in the country illegally, and creating a surgeon general position for the state.

Reuters: New California Governor Tackles Drug Prices in First Act

Sacramento Bee: Gavin Newsom CA Health Plan Includes Individual Mandate

Meanwhile, up in Washington state, Gov. Jay Inslee proposed a “public option” health care plan for residents, a move that would set the stage for a universal coverage system. (It should be noted that Inslee is a 2020 contender.)

Seattle Times: Inslee Proposes ‘Public Option’ Health-Insurance Plan for Washington

In New York, several big health care developments emerged this week. NYC Mayor Bill de Blasio plans on investing $100 million into making sure that everyone in the city — including residents in the United States illegally — is guaranteed health coverage.

The New York Times: De Blasio Unveils Health Care Plan for Undocumented and Low-Income New Yorkers

And in Albany, Gov. Andrew Cuomo, citing the looming threat to Roe v. Wade, promised to cement a woman’s right to abortion in the state’s constitution.

The Wall Street Journal: Cuomo Vows to Codify Roe V. Wade Decision Into New York Constitution


It seems these days, you can’t swing a cat without hitting someone talking about “Medicare-for-all,” but what about a Medicaid “buy-in”? Some states are considering the option as a politically palatable alternative to help people who are struggling to buy coverage on the exchanges. The plans might not offer the full range of benefits available to traditional beneficiaries, but it could be something.

Stateline: Medicaid ‘Buy-In’ Could Be a New Health Care Option for the Uninsured

Speaking of MFA: A new Politico/Harvard poll shows that 4 in 5 Democrats favor Congress enacting a taxpayer-funded national health plan. Also to note, a fair amount of Republicans (60 percent) supported the idea of letting Americans under 65 buy into Medicare.

Politico: POLITICO/Harvard Poll: Many Democrats Back a Taxpayer-Funded Health Care Plan Like Medicare For All


As of Jan. 1, hospitals have had to post their prices online — which has resulted in much grumbling from industry and experts alike who say the numbers are meaningless to consumers. Centers for Medicare & Medicaid Administrator Seema Verma acknowledged the flaws with the rules this week, but still called them an important first step toward transparency.

Modern Healthcare: Verma: Chargemaster Rule Is ‘First Step’ to Price Transparency


In the miscellaneous file for the week:

• The Chinese scientist who used CRISPR to edit the genes of human embryos had scientists up in arms over the ethical dilemma late last year. But the path of medical breakthroughs is often littered with lapses such as his. Do the ends ever justify the means in these cases? And if so, where should the line be drawn?

CNN: Unethical Experiments’ Painful Contributions to Today’s Medicine

• Juul: Public health crusader? That’s the image the e-cigarette company (under ever-increasing government scrutiny for its marketing practices directed toward youths) is going with these days. But experts are calling its new ad campaign — which touts Juul products as a way to tackle adults’ smoking habits — revisionist history.

The New York Times: Juul’s Convenient Smoke Screen

• A woman who was in a vegetative state for more than 10 years reportedly gave birth last month. The workers at the nursing facility she was in didn’t realize she was even pregnant until she went into labor, raising all kinds of questions about quality of care, abuse and the medical complications of the process.

CNN: How Does Someone in a Vegetative State Have a Baby?

• HIV prevention medication has been shown to be highly effective and, quite literally, a lifesaver to vulnerable populations. But taking it was costing some people their chance at qualifying for life insurance. Now, though, one insurer has settled a lawsuit over the denials, possibly leading the way to changes in the industry.

The New York Times: Facing Legal Action, Insurer Now Will Cover People Taking Truvada, an H.I.V.-Prevention Drug


And good news! The E. coli outbreak is officially over, so you can go back to your romaine (yay?). Have a great weekend!

Bills, Bills, Bills: Readers And Tweeters Offer Solace, Solutions And Scoldings

Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names.


2018 was a busy year for KHN, harvesting more than 1,200 medical bills submitted by readers for consideration in our “Bill of the Month” franchise, an investigative partnership with NPR. These monthly dives into patients’ cumbersome bills continue to spawn stories — as well as proposed changes to health care policy by legislators.

Sen. Bernie Sanders (I-Vt.) glommed on to the despair of an Arizona couple consumed by health care debt (“Insured But Still In Debt: 5 Jobs Pulling In $100K A Year No Match For Medical Bills,” Dec. 28).

In response to the August “Bill of the Month” feature about a schoolteacher’s $109,000 heart attack, Rep. Lloyd Doggett (D-Texas) tweeted: “When I heard Drew’s story — an Austin teacher saddled with a $100k surprise bill after surgery — I reached out to him to share my concern. We discussed my End Surprise Billing Act legislation, which would end this predatory practice.”

Sanders also shared that story on Facebook, saying: “Our health care system makes absolutely no sense. If you don’t have health insurance, you probably can’t afford to get the care you need. And if you DO have health insurance, in many cases you STILL won’t be able to afford the care you need, on top of paying a monthly premium.”

Outrageous medical bills proved something readers could relate to, as they reviewed our end-of-the-year roundup, Year One Of KHN’s ‘Bill Of The Month’: A Kaleidoscope Of Financial Challenges” (Dec. 21).

— Dr. David Johnson, Dallas


Plaudits For ‘Bill Of The Month’ Series

Thank you for publishing these stories. You are doing a public service. I work in health services research and know that the prices charged by manufacturers, hospitals and other providers are arbitrary. The more citizens are informed about this, the more power we have to change how much health care costs in this country.

— Beth Egan, Minneapolis


— Dr. Edward Hoffer, Boston


‘Bill Of The Month’: Recourse For Wounded Skier

It seems that the surgeon and the device manufacturer should have paid for Sarah Witter’s second surgery (“After Her Skiing Accident, An Uphill Battle Over Snowballing Bills,” Dec. 18). If she truly followed protocol for her rehab, they should have owned up to their mistake or to a poor manufacturing technique. Almost 10 years ago, I had an upper gastrointestinal series performed to monitor my non-Hodgkin’s lymphoma. As a result of the biopsies, I experienced significant bleeding (the doctor said that he had done this procedure several times when the patient was still on blood thinners, which I was). After I was admitted to the emergency room and received four units of blood, they repeated the procedure — and charged me for all of it. Fortunately, after threatening a lawsuit against the hospital and the doctor, they finally paid for the emergency room and operating charges.

There still may be some relief for Ms. Witter: There are companies who audit hospital bills and get paid if they find savings. When the insurance company refused to pay the hospital, they should have referred her to a company that audits hospital bills.

— Dan Kass, chief shopper of HealthCare Shopping Network, Mission, Kan.


On Twitter, readers minced no words:

— Bernie Good, Pittsburgh


— Dr. Judy Melinek, San Francisco


A Dose Of Myth-Busting

Julie Appleby’s story “Short-Term Health Plans Hold Savings for Consumers, Profits For Brokers and Insurers” (Dec. 21) perpetuates a common misunderstanding that incentives for insurance agents favor selling short-term over Affordable Care Act plans.

By comparing a monthly commission rate of 20 percent for short-term plans and a flat dollar amount for ACA policies, the article mistakenly suggests that commission earnings on short-term plans are consistently higher than those that comply with the ACA. But the premise misses the critical fact that the lifetime value of a plan — not the monthly commission rate — determines insurance agent commissions. Short-term plans are both less expensive and held by the customer for a shorter period of time than ACA plans. At eHealth, an ACA plan generates twice the revenue as each short-term policy.

Most insurance agents advocate for consumers to choose an ACA plan first, if they can afford it, because the coverage is far more comprehensive. Unfortunately, many Americans have been priced out of the ACA market and short-term policies may represent the best viable health insurance coverage at a price they can afford. Others miss the open-enrollment period and, without other options, face a year with no insurance coverage at all. The responsibility of a good insurance agent is to help all Americans gain access to the insurance policy most suitable for their individual medical and financial needs. To do anything less is not in the best interest of consumers or to the long-term success of insurance agents.

Scott Flanders, CEO of eHealth, Santa Clara, Calif.


Sad Twist On Knee Replacements

It’s true that doctors do not always tell you the reality of knee replacements upfront (“Up To A Third Of Knee Replacements Pack Pain And Regret,” Dec. 25). I had to have my right knee replaced twice. I had a metal allergy to the first implant, which I found out the hard way.

Patients should be tested for metal allergies before surgery. I am so sorry I ever had my knee replaced — it hurts worse now than it did before the surgery. I would not have my other knee replaced unless I could not walk. I was told my knee would be great until after my second surgery, when my surgeon warned me my knee would possibly always cause me pain. That would have been nice to know before my first surgery.

— Lesa Lawrence, Dallas


— Greg Mays, Nashville, Tenn.


Without knocking total knee arthroplasty, or TKA, a New Yorker wonders whether we’re moving in the right direction.

— Wendy Diller, New York City


Doing The Math On Biologics

The article “Why The U.S. Remains The World’s Most Expensive Market For ‘Biologic’ Drugs” (Dec. 20) mentioned that Cosentyx costs about $15,000 in Europe versus almost $65,000 in the United States. If it is true that someone can purchase a three-month supply for personal use in Europe — and if a three-month supply, properly handled, has a shelf life greater than three months — it seems possible for Susie to go to Italy or somewhere in Europe every three months for an estimated cost of $6,000 a year or less (with tickets purchased in advance). Adding to her travel costs the $15,000 annual cost of the drug, which conveniently can be self-injected, she could still make out far better than paying $65,000 a year in the States. Just a thought.

— Abette Jones-Bey, Blue Bell, Pa.


A tweeter offered one explanation for the pricing disparity:

— Elizabeth Henry, Olathe, Kan.


Sign-Up Season’s Unsung Heroes

Your article on navigators (“Short On Federal Funding, Obamacare Enrollment Navigators Switch Tactics,” Nov. 30) neglected to mention the group of professionals best suited to help consumers select appropriate health coverage: licensed insurance agents and brokers. Agents and brokers typically have more training and experience than navigators. They’re licensed by the states in which they work. The majority have been in business for more than 10 years.

Agents and brokers also work with their clients year-round, not just during the six-week open-enrollment period. A survey conducted by the Kaiser Family Foundation found that more than 70 percent of agents spend “most” or “a lot of” their time explaining coverage to their clients.  It’s no wonder that nearly 84 percent of adults who worked with agents and brokers when shopping for exchange coverage found them helpful — more than any other group offering assistance.

— Janet Trautwein, CEO of the National Association of Health Underwriters (NAHU), Washington, D.C.


— B. Ronnell Nolan, president and CEO of Health Agents for America, Baton Rouge, La.


Entrepreneurs Caught In The Middle

I fall into the situation described in Steven Findlay’s article “Health Insurance Costs Crushing Many People Who Don’t Get Federal Subsidies” (Dec. 14).

If you look at the typical costs for a family earning more than $100,400 a year who don’t qualify for subsidies, the cost is huge. Our current premiums for an ACA-compliant policy are about $1,400 a month with a combined $13,000 deductible for my wife and me (we are self-employed). If you have a “bad year” — say, a car accident where you are both hospitalized — your expenses jump to an estimated $29,800, or nearly 30 percent of your income. This seems to be the strategy of the health insurance companies, whereby they want health care pricing to be a fixed amount of total income. The way they get there is through lack of transparency.

After Supreme Court Chief Justice John Roberts cast the deciding vote around the constitutionality of the ACA “tax” for being uninsured, I left a great corporate job and have since started multiple companies and created jobs simply because getting health insurance through the ACA seemed certain. I am now in the position where I am wondering if I may have to stop my entrepreneurial activities and find a corporate gig again with insurance. I suspect I am not alone in this.

The continued ambiguity around this will have a stifling effect on people like us who are taking the risk to start businesses and create jobs.

— Mick Garrett, Fort Collins, Colo.


— Clayton Mowrer, Kansas City, Mo.


Band-Aid Fixes To ACA Are Like Salt To The Wound

“Ask Emily” columnist Emily Bazar offers a worthy solution that may work for a number of folks and should be explored by those whose household income is slightly above 400 percent the federal poverty level (FPL) (“Without Obamacare Penalty, Think It’ll Be Nice To Drop Your Plan? Better Think Twice,” Dec. 5). But there is a break-even point that may make this solution undoable. Since FPL is a national measure, with just two states receiving an exception (Alaska and Hawaii) to the income ceiling, for anyone who resides in a state with a high cost of living, such adjustments to take-home pay can adversely impact their ability to afford other necessities of life.

Cost of living can vary widely by state or ZIP code, yet the income ceiling for ACA subsidies is set at the national level. Insurance premiums may also vary among counties and even ZIP codes within a state. Some call this market-based pricing or pricing based on an area’s ability to pay (higher average incomes equate to higher premium prices). Still others call it price-gouging. Yet again, the income ceiling is set at the national level.

I welcome any and all ideas that would allow more folks to obtain health insurance (which, by the way, does not guarantee health care coverage). Changes need to be made to the law to level the playing field for consumers. Until all consumers have access to coverage at the same price, with the same level of subsidy be it government or employer, then we truly are putting band-aids on a heart attack. Until your age, marital status, place where you live and size of your employer no longer hinder your ability to afford health insurance coverage, there will continue to be those left out and at risk.

Unfortunately, our elected representatives at both the state and national level have little stomach to face and fix the glitches and inequities in the ACA. Their only remedy, which comes in the form of a tax on the uninsured, has taken the ACA from a solution meant to bring health insurance to all Americans to a policy that relies on those who can’t afford health insurance and are excluded from the benefits of the ACA to fund it. Now that’s ironic.

— Susan Frangione, Rockville, Md.


— Rob Levine, Minneapolis


What’s Really Hurting ACA Enrollment

I can tell you the real reason many Americans gave up on enrolling in an Obamacare plan this year (“Need Health Insurance? The Deadline Is Dec. 15,” Dec. 10).

I had a fairly good health insurance plan under the Affordable Care Act in 2014-15. In 2015, my income changed, and I was eligible for Medicaid under Illinois’ expansion of that federal-state program. However, in July 2018, Medicaid determined that I no longer qualified. I went online to the ACA marketplace to try to find an ACA plan I could afford. To my surprise, the plans available in 2014 were no longer available. The two dozen plans available in my area are not ideal. Some provide low coverage. Some are from carriers that almost all of my doctor groups do not accept. Even some “gold”-level plans have extremely high copays. Though my premium in 2018 did not increase much, it was offset by high hospital copays and burdensome deductible and coinsurance obligations. Prescription copays were percentage-based, not a dollar amount, which made it more expensive to pay for prescriptions.

This is all hurting many Americans in my income bracket. The drop in enrollment in ACA plans is because no one can afford most of these low-level coverage plans in the ACA marketplace. And almost all the ACA plans have limited access to providers, especially specialists, making getting medical treatment nearby difficult. The ACA has been changed and tweaked so that many Americans no longer can afford to buy any of the plans without going into debt if a serious illness arises.

— Lena Conway, Naperville, Ill.

Emergency Medical Responders Confront Racial Bias

A recent study out of Oregon suggests emergency medical responders — EMTs and paramedics — may be treating minority patients differently from the way they treat white patients.

Specifically, the scientists found that black patients in their study were 40 percent less likely to get pain medication than their white peers.

Jamie Kennel, head of emergency medical services programs at Oregon Health and Science University and the Oregon Institute of Technology, led the research, which was presented in December at the Institute for Healthcare Improvement Scientific Symposium in Orlando, Fla.

The researchers received a grant to produce the internal report for the Oregon Emergency Medical Services department and the Oregon Office of Rural Health.

Outright discrimination by paramedics is rare, the researchers say, and illegal; in these cases, unconscious bias may be at work.

A few years ago, Leslie Gregory was one of a very few black female emergency medical technicians working in Lenawee County, Mich. She said the study’s findings ring true based on her experience.

She remembered one particular call — the patient was down and in pain. As the EMTs arrived at the scene, Gregory could see the patient was black. And that’s when one of her colleagues groaned.

“I think it was something like: ‘Oh, my God. Here we go again,’” Gregory said. She worried — then, as now — that because the patient was black, her colleague assumed he was acting out to get pain medication.

“I am absolutely sure this was unconscious,” added Gregory, who now lives and works in Portland, Ore., where she founded a nonprofit to spread awareness about racial disparities in health care. “At the time, I remember, it increased my stress as we rode up on this person. Because I thought, ‘Now am I going to have to fight my colleague for more pain medication, should that arise?’”

Leslie Gregory, a Portland physician assistant, asks, “How can a person of color not disrespect a system that is constantly studying and talking about these disparities, but does nothing to fix it?” She wants the CDC to declare the effects of racism a national health crisis.(Kristian Foden-Vencil/Oregon Public Broadcasting)

Unconscious bias can be subtle — but, as this new report shows, it may be one of the factors behind race-linked health disparities seen across the U.S.

The study looked at 104,000 medical charts of ambulance patients from 2015 to 2017. It found that minority patients were less likely to receive morphine and other pain medication compared with white patients — regardless of socioeconomic factors, such as health insurance status.

During a shift change at American Medical Response headquarters in Portland,  EMTs and paramedics discussed the issue with a reporter as they got their rigs ready for the next shift.

Jennifer Sanders, who has been a paramedic for 30 years, was adamant that her work is not affected by race.

“I’ve never treated anybody different — regardless,” said Sanders.

Most of the emergency responders interviewed, including Jason Dahlke, said race doesn’t affect the treatment they give. But Dahlke also said he and some of his co-workers are thinking deeply about unconscious bias.

“Historically it’s the way this country has been,” Dahlke said. “In the beginning, we had slavery and Jim Crow and redlining — and all of that stuff you can get lost in on a large, macro scale. Yeah. It’s there.”

Paramedic Jason Dahlke says he can see how unconscious bias could slip into an emergency responder’s decisions and taint health care. He’s worked hard to be aware of it, in hopes of preventing those disparities in care.(Kristian Foden-Vencil/Oregon Public Broadcasting)

Asked where he thinks unconscious bias could slip in, Dahlke talked about a patient he just treated.

The man was black and around 60 years old. Dahlke is white and in his 30s. The patient has diabetes and called 911 from home, complaining of extreme pain in his hands and feet.

When Dahlke arrived at the patient’s house, he followed standard procedure and gave the patient a blood glucose test. The results showed that the man’s blood sugar level was low.

“So it’s my decision to treat this blood sugar first. Make sure that number comes up,” Dahlke said.

He gave the patient glucose — but no pain medicine.

Dahlke said he did not address the man’s pain in this case because by the time he had stabilized the patient they had arrived at the hospital — where it was the responsibility of the emergency department staff to take over.

“When people are acutely sick or injured, pain medication is important,” Dahlke said. “But it’s not the first thing we’re going to worry about. We’re going to worry about life threats. You’re not necessarily going to die from pain, and we’re going to do what satisfies the need in the moment to get you into the ambulance and to the hospital and to a higher level of care.”

Dahlke said he is not sure whether, if the patient had been white, he would have administered pain medicine, though he doesn’t think so.

“Is it something that I think about when I come across a patient that does not look like me? I don’t know that it changes my treatment,” he said

Asked whether treatment disparities might sometimes be a result of white people being more likely to ask for more medications, Dahlke smiled.

“I wonder that — if, in this study, if we’re talking about people of color being denied or not given narcotic medicines as much as white people, then maybe we’re overtreating white people with narcotic medicines.”

Research has found African-Americans more likely to be deeply distrustful of the medical community, and that might play a role in diminished care, too. Such distrust is understandable and goes back generations, said Gregory.

“How can a person of color not disrespect a system that is constantly studying and talking about these disparities, but does nothing to fix it?” she asked.

Gregory wrote an open letter to the Centers for Disease Control and Prevention in 2015, asking it to declare racism a threat to public health.

Past declarations of crisis — such as those focusing attention on problems such as smoking or HIV — have had significant results, Gregory noted.

But the CDC told Gregory, in its emailed response, that while it supports government policies to combat racial discrimination and acknowledges the role of racism in health disparities, “racism and racial discrimination in health is a societal issue as well as a public health one, and one that requires a broad-based societal strategy to effectively dismantle racism and its negative impacts in the U.S.”

Kennel said false stereotypes about race-based differences in physiology that date to slavery also play a role in health care disparities. For example, despite a lack of any supporting science, some medical professionals still think the blood of African-Americans coagulates faster, Kennel said, citing a recent study of medical students at the University of Virginia.

Another question in the survey asked the students whether they thought African-Americans have fewer pain receptors than whites. “An uncomfortably large percentage of medical students said, ‘Yes, that’s true,’” said Kennel.

On top of that, he said, EMTs and paramedics often work in time-pressured situations, where they are limited to ambiguous clinical information and scarce resources. “In these situations, providers are much more likely to default to making decisions [based] on stereotypes,” he said.

Disparities in health care are well-documented. Whites tend to get better care and experience better outcomes, whether they’re in a doctor’s office or the ER. But before Kennel’s study, nobody knew whether the same was true in the back of an ambulance.

And they nearly didn’t get to know, because the research required ambulance companies to release highly sensitive data.

“We were prepared to maybe not look that great,” said Robert McDonald, the operations manager at American Medical Response in Portland. AMR is one of the nation’s largest ambulance organizations, and it shared its data from more than 100,000 charts with Kennel.

Some people chalk up the disparities he found to differences in demography and health insurance status, but Kennel said he controlled for those variables.

So now that AMR knows about disparities in its care, what can the company do?

“My feeling is we’re probably going to put some education and training out to our folks in the field,” McDonald said.

In addition, he said, AMR is going to hire more people of color.

“We want to see more ethnicities represented in EMS — which has historically been a white, male-dominated workforce,” McDonald said.

AMR’s policies must change, too, he added. The company has purchased software that will enable patients to read medical permission forms in any of 17 different languages. And the firm is planning an outreach effort to communities of color to explain the role of EMS workers.

This story is part of a partnership that includes Oregon Public BroadcastingNPR and Kaiser Health News.

Johnson & Johnson CEO Warns That Pharma Should Police Itself Over Drug Prices As Other Options Could Be ‘Onerous’

“If we don’t do this as an industry, I think there will be other alternatives that will be more onerous for us,” Johnson & Johnson CEO Alex Gorsky said at the J.P. Morgan Healthcare Conference in California. Drug pricing was just one of the many topics that were being hotly discussed at the annual event that draws the movers-and-shakers in the industry.

Flurry Of Movement On Capitol Hill On Drug Pricing May Signal Possible Rough Waters Ahead For Pharma

Sen. Chuck Grassley (R-Iowa) was one of a handful of lawmakers who have introduced legislation to curb high drug costs in the first few weeks of Congress being back in session. The topic is seen as one of only a few bipartisan issues that may get addressed by a divided Congress this year. In other pharmaceutical news, government officials are worried that drugmakers are using scare tactics to keep competition out of the marketplace.

Extreme Temperatures May Pose Risks To Some Mail-Order Meds

Take a look at your prescription bottles. Most say “Store at room temperature” or “Keep refrigerated.”

But what happens when drugs are delivered by mail? Were those instructions followed as the medicine wended its way from the pharmacy to your doorstep?

Those questions haunt Loretta Boesing, who lives in Park Hills, a small town in the hills of eastern Missouri, where the weather varies dramatically from season to season.

“It’s crazy,” Boesing said. “We sometimes experience temperatures like they would feel in Arizona. Sometimes we experience temperatures like they would feel up north.”

In 2012, when son Wesley was 2 years old, he got so sick from the flu that he needed a liver transplant.

The transplant surgery went well, but just a few months later, lab tests showed Wesley’s body appeared to be rejecting the organ.

Boesing felt both devastated and guilty.

“I feel the extra duty of not just protecting his life, but the life that lives on inside him,” she said.

Wesley didn’t lose his new liver, but during his weeks in the hospital, Boesing’s mind raced, thinking about what might have gone wrong.

She remembered that when his anti-rejection medications were last delivered to their house, the box had been left outside by the garage, where it sat for hours.

Temperatures that day were well over 100 degrees, well beyond the safe temperature range listed on the drug’s guidelines.

At the time, she hadn’t worried about it.

“Even though I see plainly on the bottle that it says, ‘Store at room temperature,’” Boesing said, “I still thought, ‘Ah, someone’s making sure it’s safe.’”

But after Wesley’s setback, Boesing swore off mail-order pharmacy altogether, and this year she started a Facebook group for patients who share her concerns about how extreme temperatures during shipping could affect the prescription drugs that many people receive by mail.

As of 2016, prescriptions fulfilled by mail accounted for nearly a quarter of total U.S. spending on prescriptions (before rebates and discounts), according to a report from IQVIA’s Institute for Human Data Science.

Health insurers typically contract with companies known as pharmacy benefit managers to handle the complex process of getting medicine to patients. PBMs negotiate with drugmakers on prices and rebates, help insurers decide which drugs to cover and handle mail-order shipping.

Mail order is a money saver for PBMs, and, in turn, they’ve touted the potential advantages for patients — such as 90-day refills for the cost of a 30-day copay, and the added convenience, especially for rural or housebound patients.

But Boesing wants insurers and their PBMs to reconsider these incentives and their practices in light of temperature concerns. She says they must ensure that their patients have easy access to retail pharmacies — unless the mail-order services can prove that drugs are getting to patients at the right temperatures.

The three biggest PBMs are Express Scripts, CVS Caremark and OptumRX. They insist they’ve got mail-order drug shipment down to a science.

Inside an enormous OptumRX warehouse in a Kansas City suburb, lines of orange prescription bottles fly along conveyor belts, while pharmacists scan bar codes and technicians refill bins of pills.

Lead pharmacist Alysia Heller explains that this shipping behemoth, which sends out as many as 100,000 prescriptions a day, includes a system to account for weather.

“If there’s an extreme heat situation where a product is going into 100-plus-degree weather, the system will tell the technician to add an extra ice pack,” Heller said, “because we’ve monitored the ZIP code and the weather in that area.”

But at OptumRX and across the industry, that level of temperature-controlled shipping is usually reserved only for a relatively small number of drugs — such as certain types of insulin, or hepatitis C drugs that have specific refrigeration requirements.

Standard, room-temperature medications (like most drugs for blood pressure or cholesterol, which make up the vast majority of prescriptions shipped) are typically sent in bubble mailers without any temperature monitors.

Stephen Eckel, a pharmacy professor at the University of North Carolina at Chapel Hill, said those practices can lead to some drugs being damaged.

“A lot of people enjoy the convenience of mail order, but there are some risks they’ve got to understand,” said Eckel. He said it’s possible that drugs in liquid form, such as the one Wesley was taking, could potentially be damaged by exposure to extreme heat or cold.

He predicts it’s just a matter of time before mail-order pharmacies will expand their use of temperature controls and add individual temperature monitors to all packages, so customers can see whether their medications got too hot or too cold in transit.

But Adam Fein, a consultant on pharmaceutical economics and drug distribution, called the temperature concerns overblown. He pointed out that many states already require insurance companies and/or PBMs to offer access to retail pharmacies if customers prefer.

“We have literally billions and billions of prescriptions that have been dispensed by mail over many years without evidence of widespread harm,” Fein said.

The Pharmaceutical Care Management Association is a national trade industry group for PBMs. In response to questions about temperature concerns and the safety of mail-order drugs, the association wrote in a statement: “Mail-service pharmacies adhere to all Food and Drug Administration rules, ship those prescription medications that may be adversely affected by extreme heat in refrigerated packaging, and notify patients to make sure those packages have been delivered properly.”

Some room-temperature drugs are approved to spend up to 24 hours in temperatures from as low as the upper 50s to as high as 104 degrees. But scientists just don’t know how a number of medications respond to more extreme temperatures — such as they might experience on a freezing porch or in the back of a sweltering truck.

A few studies suggest that some inhalers or antibiotics can lose potency over time.

Many industry experts think mail-order pharmacy is on the cusp of a boom driven by the development of new specialty drugs, especially biologics. Many of those often come with a hefty price tag and are generally not handled by retail pharmacies. These specialty drugs, many of which are injected, can be more vulnerable to temperature swings.

Competition in the mail-order drug industry is heating up, with Amazon’s acquisition last summer of online pharmacy PillPack, and the announcement in December that Walgreens would work with FedEx to offer next-day medication delivery.

Fein said more temperature controls and monitoring would do little more than drive up costs in an industry that’s been successful in large part because of its low operating costs.

But after collecting more than 76,000 signatures for an online petition on the issue, Loretta Boesing said she’s convinced a larger health problem is being shrugged off.

In Missouri, the Board of Pharmacy has decided to review its mail-order prescription policies and invited Boesing to testify.

Her son still needs prescriptions, but Boesing has stopped using Walgreens’ Specialty Pharmacy, which was shipping the drugs. She obtained a waiver that lets her fill Wesley’s prescriptions at a specialized pharmacy affiliated with a children’s hospital in St. Louis. She makes the two-hour round-trip drive every month to pick up the medicine.

After connecting with patients all over the country, she said, her advocacy is no longer just about keeping Wesley safe.

“I don’t want my son to have to receive special treatment,” Boesing said. “I want everyone to have access to safe medications.”

This story is part of a partnership that includes KCUR, NPR and Kaiser Health News.


KHN’s coverage of these topics is supported by
Laura and John Arnold Foundation
and
Heising-Simons Foundation

Medical Marketing In The U.S. Has Boomed Over Past Two Decades–With Meager Oversight To Keep It In Check

A new analysis of marketing data from the FDA, Medicare, other federal and state agencies, private companies and medical research finds a 69 percent increase, to $29.9 billion, over a recent 20-year period. “Marketing drives more treatments, more testing” that patients don’t always need, said Dr. Steven Woloshin, a Dartmouth College health policy expert.

As Pharma Returns To Status Quo On Drug Prices, Trump Meets With Top Advisers To Discuss Frustrations

“The president’s been really clear — prices of drugs need to be coming down, not going up,” said HHS Secretary Alex Azar, who was reportedly a part of the meeting. Meanwhile, Democrats on Capitol Hill are looking to score some early wins with small drug pricing legislation.

Health Care Industry Spends $30B A Year Pushing Its Wares, From Drugs To Stem Cell Treatment

Hoping to earn its share of the $3.5 trillion health care market, the medical industry is pouring more money than ever into advertising its products — from high-priced prescriptions to do-it-yourself genetic tests and unapproved stem cell treatments.

Spending on health care marketing doubled from 1997 to 2016, soaring to at least $30 billion a year, according to a study published Tuesday in JAMA.

“Marketing drives more testing. It drives more treatments. It’s a big part of why health care is so expensive, because it’s the fancy, high-tech stuff things that get marketed,” said Steven Woloshin, co-director of the Center for Medicine and Media at The Dartmouth Institute for Health Policy and Clinical Practice. His study captured only a portion of the many ways that drug companies, hospitals and labs promote themselves.

Advertising doesn’t just persuade people to pick one brand over another, said Woloshin. Sophisticated campaigns make people worry about diseases they don’t have and ask for drugs or exams they don’t need.

Consumer advocates say that taxpayers pay the real price, as seductive ads persuade doctors and patients alike to order pricey tests and brand-name pills.

“Whenever pharma or a hospital spends money on advertising, we the patients pay for it — through higher prices for drugs and hospital services,” said Shannon Brownlee, senior vice president of the Lown Institute, a Brookline, Mass., nonprofit that advocates for affordable care. “Marketing is built into the cost of care.”

High costs ultimately affect everyone, because they prompt insurance plans to raise premiums, said Diana Zuckerman, president of the National Center for Health Research, a nonprofit that provides medical information to consumers. And taxpayers foot the bill for publicly funded insurance programs, such as Medicare.

“These ads can be amazingly persuasive, and they can exploit desperate patients and family members,” said Zuckerman, who was not involved in the new study.

Drug companies spend the bulk of their money trying to influence doctors, showering them with free food, drinks and speaking fees, as well as paying for them to travel to conferences, according to the study.

Dr. Lisa Schwartz and Dr. Steven Woloshin(Courtesy of the Dartmouth Institute for Health Policy & Clinical Practice)

Yet marketers also increasingly target consumers, said Woloshin, who wrote the study with his wife and longtime research partner, Dartmouth’s Dr. Lisa Schwartz, who died of cancer in November.

The biggest increase in medical marketing over the past 20 years was in “direct-to-consumer” advertising, including the TV commercials that exhort viewers to “ask your doctor” about a particular drug. Spending on such ads jumped from $2.1 billion in 1997 to nearly $10 billion in 2016, according to the study.

A spokeswoman for the pharmaceutical industry group, PhRMA, said that its ads provide “scientifically accurate information to patients.” These ads “increase awareness of the benefits and risks of new medicines and encourage appropriate use of medicines,” said Holly Campbell, of PhRMA.

The makers of genetic tests — including those that allow people to learn their ancestry or disease risk —also bombard the public with advertising. The number of ads for genetic testing grew from 14,100 in 1997 to 255,300 in 2016, at a cost that year of $82.6 million, according to the study. AncestryDNA spends more than any other company of its kind, devoting $38 million to marketing in 2016 alone.

Some companies are touting stem cell treatments that haven’t been approved by federal regulators. The Food and Drug Administration has approved stem cell therapy for only a few specific uses — such as bone marrow transplants for people with leukemia. But hundreds of clinics claim to use these cells taken from umbilical cord blood to treat disease. Many patients have no idea that these stem cell therapies are unapproved, said Angie Botto-van Bemden, director of osteoarthritis programs at the Arthritis Foundation.

Stem cell clinics have boosted their marketing from $900,000 in 2012 to $11.3 million in 2016, according to the study.

In recent months, the FDA has issued warnings to clinics marketing unapproved stem cell therapies. Twelve patients have been hospitalized for serious infections after receiving stem cell injections, according to the Centers for Disease Control and Prevention.

Medical advertising today goes beyond TV and radio commercials. Some online campaigns encourage patients to diagnose themselves, Woloshin said.

The website for Restasis, which treats dry eyes, prompts patients to take a quiz to learn if they need the prescription eye drops, said Woloshin, who co-wrote a February study with Schwartz on the drug’s marketing strategy. The Restasis website also allows patients to “find an eye doctor near you.”

Many of the doctors included in the Restasis directory have taken gifts from its manufacturer, Allergan, Woloshin said. The doctor directory includes seven of the top 10 physicians paid by the company, his study says.

In a statement, Allergan spokeswoman Amy Rose said the company uses direct-to-consumer advertising “to support responsible disease awareness efforts.” The ads “do not displace the patient-physician relationship, but enhance them, helping to create well-informed and empowered consumer and patient communities.”

Drug sites don’t just lead patients to doctors. They also provide scripts for suggested conversations. For example, the website for Viagra, which treats erectile dysfunction, provides specific questions for patients to ask.

The website for Addyi, often called the “female Viagra,” goes even further. Patients who answer a number of medical questions online are offered a 10- to 15-minute phone consultation about the drug for $49. Patients who don’t immediately book an appointment receive an email reminder a few minutes later.

“This is more evidence,” Brownlee said, “that drug companies are not run by dummies.”

Will I Always Face The Threat Of A Peanut-Laden Kiss Of Death?

Whenever I see a report touting possible new peanut allergy treatments, I devour it. I can’t help it. It’s an occupational hazard for any health journalist whose reporting specialty and medical history intertwine.

I write about the business of health care, focusing on how consumers interact with the system — what we pay, what we get and why American care costs so much. But in this particular instance, I have another kind of authority: 26 years of life-threatening allergies to nuts and peanuts.

So last month, when California-based Aimmune Therapeutics sparked optimistic headlines after releasing clinical trial results that its allergy product, AR101, would reduce the risks linked to an accidental exposure to peanuts, I received the usual wave of questions from friends, co-workers and my parents: Would you try it? Could this help?

Aimmune is just one company eyeing the prize. Childhood peanut allergy diagnoses increased more than 20 percent in the United States from 2010 to 2017. The global market for relief is worth as much as $2 billion. The French drugmaker DBV Technologies is also working to commercialize a peanut allergy patch. Other companies, including industry giant Sanofi, are following their lead.

If any one of them succeeds, it could change my life.

My friends call nuts “Shefali poison.” My allergies first surfaced when, as a 15-month-old, I picked Thai noodles off an aunt’s plate and developed hives on my face, and then a few months later when I tasted my mom’s kaju barfi – an Indian dessert with cashews – and ended up in the hospital. Nobody in my family had ever heard of peanut allergies.

I’ve carried epinephrine since I was 7 years old. My friends are trained to inject it in my leg, the standard procedure for an emergency allergen exposure. though I luckily haven’t had to take a shot of it since I was 4. (Another child in my Montessori class had a peanut butter sandwich for lunch.)

My mom also recalls another incident when she had to pick me up early from day care because the class was making peanut butter bird feeders. And I spent too many years of pre-adolescence eating lunch at the designated “peanut-free table.” Now, I can only dream of flying to visit my parents for Christmas without worrying about whether my seatmate’s snacks might induce anaphylaxis. And yes, kissing someone who has just eaten peanut butter would put my life in danger.

But are these pills and patches a true breakthrough for people like me?

I approached the question as I would any other assignment. I read the research, called immunologists, and spoke with economists and drug pricing experts about whether these treatments offer meaningful benefit.

One of the first things I heard: “We are still in the infancy of these treatments,” said Dr. Corinne Keet, a pediatric allergist at Johns Hopkins University.

Shefali Luthra (second from right), pictured in the seventh grade with her school math team, carried epinephrine in a fanny pack as a child, in case she had an allergic reaction. (The fanny pack, thankfully, has since been replaced with a purse.)(Courtesy of the Luthra family)

Medically, there’s a lot we don’t know about the risks, how much these drugs could help and how long any effects would last.

“None of these treatments have been shown to prevent fatal reaction,” Keet emphasized.

The idea behind them is to desensitize people. Aimmune’s “peanut pill” is modeled on the oral therapies some specialists use to wean allergic kids back on to nuts. This approach has gained popularity in recent years, especially for children with multiple allergies, or when it’s a substance particularly hard to avoid.

A colleague’s young daughter, who was born with multiple allergies, used that very treatment, as did a younger cousin of mine who, for the first several years of her life, was allergic to — not joking — almost everything but fruits and vegetables. In my case, this therapy came into vogue after I was too old to have a good chance of it weakening my sensitivities.

How it works: Kids ingest tiny, escalating doses of peanut protein. They then stay on peanut protein — Aimmune recommends the pill, though other doctors I spoke to suggested a little bit of peanut — as a maintenance drug.

But it’s unclear how much the new therapies would improve upon that ad hoc oral immunotherapy allergists are already offering. Instead of drugs, they use store-bought peanut protein, usually de-fatted peanut flour available online for as little as $1 a pound. This method isn’t approved by the Food and Drug Administration, and often isn’t covered by insurance — though doctors’ visits can be billed as “food challenges” or other visits that are typically covered.

In contrast, Aimmune’s product is expected to cost between $5,000 and $10,000 for the first six months of use, and $300 to $400 per month after. Analysts predict DBV’s will cost more than $6,000 for a year’s supply, though the company says it has not yet determined a price. DBV, Aimmune’s chief rival, has come up with a wearable skin patch that would transmit tiny, desensitizing protein doses. It declined to estimate a price, but it does not view oral immunotherapy as a competitor, said Joseph Becker, a company spokesman.

“There’s excitement, there’s caution and a lot of unanswered questions,” warned Dr. Erwin Gelfand, a pediatrics and immunology professor at the University of Colorado.

According to Aimmune’s results, published in the prestigious New England Journal of Medicine, two-thirds of allergic children could ingest 600 milligrams of peanut without harm after going through treatment.

To be clear, even with Aimmune’s help, someone like me still couldn’t safely eat PB&J. But it would desensitize me enough that I could taste a friend’s wine even if he recently ate pad thai.

Still, the treatment comes with caveats.

While 496 children started the trial, only 372 completed it. Of the 20 percent who backed out, half did so because of adverse events. About 14 percent of kids getting treatment still had to take epinephrine, and one experienced anaphylaxis, a severe reaction that can involve rashes, vomiting, a tightening throat and difficulty breathing. (For an allergic kid, even the possibility is maybe one of the most terrifying things you can imagine.)

Children who completed the regimen still had to take small doses of peanut protein daily, either the Aimmune drug or a controlled peanut serving. Statistically significant benefits were clear only in patients through age 17, though Dr. Daniel Adelman, the company’s chief medical officer, said Aimmune plans to do a follow-up trial for adults.

And the results don’t indicate who is likely to benefit, or how long improvements would last. That’s impossible to know, Adelman said, though he suggested accidental peanut exposure is scary enough — and pure avoidance ineffective enough — that the treatment is still worth it.

But all this means that anyone who has gone through Aimmune’s regimen would still want to carry epinephrine, and try to avoid peanuts.

“Not everybody responds well,” Gelfand said. When you factor in those details, the results are “not all that impressive,” he argued.

Dr. Tina Sindher, a pediatric allergist at Stanford University, pointed out that the Aimmune pill is a repackaged, clinically tested version of that homegrown oral therapy many allergists have already been using. DBV’s peanut patch, Viaskin, to a lesser extent, is the same — more convenient, perhaps, and more regulated, but still a variation on the existing medical approach.

“This concept has been around for a long time,” she said.

What’s new is the addition of labor, standardization and federal oversight — which companies then say demonstrates increased value.

It highlights a pattern I’ve noticed from my reporting: Drugmakers develop medication that refines a low-tech remedy, run a clinical trial to secure FDA approval, and then sell it at a higher price. For pharma, it’s a logical way to profit. But it puts patients in a bind.

“The hard outcome is we have these new products and they’re just about as good or slightly better than what we have,” said Nicholson Price, an assistant professor at the University of Michigan Law School, who studies drug pricing. “And they’re a lot more expensive.” He noted: “That’s when the choices get hard, and we’re not good at making hard choices.”

Also skeptical? The closest authority I know: my mother, who raised me with peanut allergies when they were more or less unheard of, and is now doing it all over again for my 10-year-old brother. (My other brother, my twin, was allergy-free until about a year ago.)

“It’s not worth it,” my mom told me. Her concern? Getting any of us to maintain a peanut dose — without knowing how long that reduced sensitivity would last — could induce what she called “a false sense of security.”

This thinking isn’t out of line, Sindher suggested. The way these studies are touted, she said, often “gloss over the fact that there’s a lot we don’t know.”

So for now, I’ll have to maintain my distance from the newsroom stash of Reese’s Pieces. My epinephrine and I aren’t parting ways anytime soon.


KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.

Drugmakers ‘Not Being Fair To The Consumer,’ Trump Accuses As Pharma Goes Back To Status Quo On Raising Prices

President Donald Trump’s tweet came in contrast to a statement from HHS Secretary Alex Azar that praised Trump’s leadership as the reason the pharma industry had announced “smaller and fewer drug price increases.” Meanwhile, the movers and shakers in the industry are headed to the J.P. Morgan Healthcare Conference this week.

Drugmakers ‘Not Being Fair To The Consumer,’ Trump Accuses As Pharma Goes Back To Status Quo On Raising Prices

President Donald Trump’s tweet came in contrast to a statement from HHS Secretary Alex Azar that praised Trump’s leadership as the reason the pharma industry had announced “smaller and fewer drug price increases.” Meanwhile, the movers and shakers in the industry are headed to the J.P. Morgan Healthcare Conference this week.

Must-Reads Of The Week From Brianna Labuskes

Happy New Year! Welcome to 2019 and the 116th Congress! I hope everyone had a wonderful and restful break, because now the fun (or something in that neighborhood) starts again.

Democrats are raring to go now that the new class has been sworn in and Nancy Pelosi has retaken the House gavel. They’re setting the stage to put Republicans in the political hot seat with a vote to formally intervene in the Affordable Care Act lawsuit currently moving through the courts.

I’m pretty sure everyone at this point realizes that vowing to protect preexisting conditions was (and will be) a winning issue on the campaign trail. The Democrats’ move will (and, let’s be honest, is designed to) put the GOP in the awkward position of voting against those popular provisions.

The Washington Post: The New Congress: Pelosi Retakes House Gavel As Shutdown Continues

The Washington Post: House Democrats Vote to Defend ACA in Court — and Jam Republicans

Then on the states’ side of things, the attorneys general leading the defense of the health law have filed an appeal against the federal judge’s ruling (from December, I know it feels ages ago) that the ACA can’t stand without the individual mandate penalty. The filing was, obviously, completely expected, but it does continue to move the case down a long legal path likely to end at the Supreme Court.

The Wall Street Journal: Democratic-Led States Appeal Ruling Invalidating Affordable Care Act


Stories about excessive human waste piling up in national parks are grabbing headlines, but when it comes to the shutdown the issues go much deeper than that for Native Americans. Because of treaties, tribes receive a significant amount of the funding they need to provide basic services (like running health clinics) from the federal government. So, the shutdown cuts deeper for them than in other places in the country.

“The federal government owes us this: We prepaid with millions of acres of land. We don’t have the right to take back that land, so we expect the federal government to fulfill its treaty and trust responsibility,” said Aaron Payment, the chairman of the Sault Ste. Marie Tribe, in The New York Times’ coverage.

The New York Times: Shutdown Leaves Food, Medicine and Pay in Doubt in Indian Country

P.S. If you’re confused about the shutdown and what health programs are affected, 1) you’re not alone, and 2) read KHN’s roundup, which, without bias, is the most comprehensive health-related breakdown I’ve seen. Cliff notes, though: Most big-ticket items (like Medicaid and Medicare) were already funded by Congress earlier in the year and are insulated from the standoff’s dramatics.

Kaiser Health News: How The Government Shutdown Affects Health Programs


Bristol-Myers Squibb kicked off the year with a huge $74 billion deal with Celgene. The experts at Stat break down exactly what the acquisition means for the industry. A big takeaway is that one of the sector’s largest companies will essentially cease to exist. The deal could also spark more megamergers and further consolidation of the biotech landscape — which, as you can imagine, will not be good for drug prices.

Stat: 9 Big Takeaways From the $74 Billion Bristol-Celgene Deal

Next week, movers and shakers in the biotech industry will be flocking to San Francisco for the annual J.P. Morgan Healthcare Conference. It’s the place to see and be seen, but some attendees want to be anywhere but there. Why? The location.

Stat: Will San Francisco’s Issues Push People Away From J.P. Morgan?


Adding work requirements to Medicaid has proven to be the honey it takes to make expanding coverage more palatable to Republican states. But, in Arkansas — the testing ground for what exactly those rules look like in practice — thousands of residents are getting kicked off the Medicaid rolls. A picture of confusion, flawed technology and basic human error is emerging as advocates try to figure out what is going wrong.

Politico: Conservative Health Care Experiment Leads to Thousands Losing Coverage


If you managed to tune out a bit from the news over the holidays, here are some developments you should know about:

A second migrant child died in U.S. custody, prompting President Donald Trump to attempt to shift blame to the Democrats. The administration has been under ever-increasing scrutiny for the quality of care the young migrant children are receiving.

The New York Times: Trump Blames Democrats Over Deaths of Migrant Children in U.S. Custody

Hospitals were handed a major victory when a judge blocked cuts to the 340B drug program, which requires pharmaceutical manufacturers to sell drugs at discounts to hospitals serving large proportions of low-income and vulnerable people, such as children or cancer patients. The judge said the administration overstepped its authority in its push to try to lower drug prices.

Stat: Judge Blocks Trump Administration Cuts to 340B Hospital Payments

A damning investigation into the nation’s major hospital watchdog found that more than 100 psychiatric hospitals have remained fully accredited by the commission despite serious safety lapses, some of which were connected to the death, abuse or sexual assault of patients.

The Wall Street Journal: Psychiatric Hospitals With Safety Violations Still Get Accreditation


And in my miscellaneous file: 

• The old and powerful veteran advocacy groups — aka the “Big Six” — have been major players on Capitol Hill for years. But their power is diminishing as leaner, more efficient and more tailored groups chip away at the establishment and reflect the priorities of a new generation of veterans.

The New York Times: Their Influence Diminishing, Veterans Groups Compete With Each Other and Struggle With the V.A.

• The prominent Memorial Sloan Kettering Cancer Center has not been having a good fall. That’s in part due to the fabulous reporting done by The New York Times and ProPublica, which revealed conflicts of interest among the organization’s leaders. If you haven’t kept up with the story, this offers a great overview on how this ethical morass is playing out not only there but across the country as well.

The New York Times: Memorial Sloan Kettering’s Season of Turmoil

• Does medication-assisted treatment for opioid addiction simply replace one drug with another? Or is it necessary to stop a relentless and sweeping epidemic that has claimed far too many victims? That’s the raging debate as experts try to get their arms around the crisis.

The New York Times: In Rehab, ‘Two Warring Factions’: Abstinence Vs. Medication

• An outbreak of cancer in children is pitting families deep in Trump Country against the president’s agenda to roll back health and environmental restrictions.

The New York Times: A Trump County Confronts the Administration Amid a Rash of Child Cancers

• Between salmonella in turkeys and E. coli in romaine lettuce, the country was beset with foodborne illness outbreaks last year. But one of the biggest recalls is one you probably haven’t even heard about.

New Food Economy: The Listeria Scare That Hit Whole Foods, Trader Joe’s, and Walmart Led to 100 Million Pounds of Recalled Product — And No One Noticed


Apparently, New Year’s resolutions won’t bring you joy (whether you achieve them or not), but if one of yours is to switch up your diet, check out the newly released rankings from U.S. News & World Report.

Pharma Companies Trying To Please Both Trump And Wall Street Stuck Between A Rock And A Hard Place

President Donald Trump had promised to lower drug costs, but pharmaceutical companies — after six months of a self-imposed hiatus on price hikes — are mostly drifting back toward the status quo. In other pharmaceutical news, expensive hepatitis C drugs aren’t being covered for Medicaid patients in Puerto Rico.

Bristol-Meyers Announces $74B Merger With Celgene In Deal Primed To Have Sweeping Implications For Drug Industry

In the first major pharmaceutical deal of 2019, Bristol-Myers Squibb says it will buy Celgene, a maker of cancer-fighting drugs, in a merger valued at $74 billion. According to Stat, Bristol-Myers has been under pressure to set a new course since August 2016, when a big study of its cancer immunotherapy, Opdivo, failed to show a benefit in previously untreated patients with non-small cell lung cancer. Analysts look at what the deal means to the industry at large.

When Medicine Makes Patients Sicker

ANN ARBOR, Mich. — Despite the jackhammer-like rhythm of a mechanical ventilator, Alicia Moreno had dozed off in a chair by her 1-year-old’s hospital bed, when a doctor woke her with some bad news: The common stool softener her son, Anderson, was given months earlier had been contaminated with the bacterium Burkholderia cepacia.

Suddenly, Anderson’s rocky course made medical sense. B. cepacia was the same unusual bacterium mysteriously found in the boy’s respiratory tract, temporarily taking him off the list for a heart transplant. The same bacterium resurfaced after his transplant and combined with a flu-like illness to infect his lungs. He’s been on a ventilator ever since.

The tainted over-the-counter medicine, docusate sodium, routinely prescribed to nearly every hospitalized patient to avert constipation, caused Anderson to suffer “serious and dangerous life-threatening injuries,” a lawsuit filed by his family alleges. The drug was eventually recalled, but only after a Texas hospital staff noticed an uptick in B. cepacia infections, prompting a six-month investigation that led back to the tainted drug and its Florida manufacturing plant.

“Something that was supposed to help him hurt him,” Alicia Moreno said.

Since the start of 2013, pharmaceutical companies based in the U.S. or abroad have recalled about 8,000 medicines, comprising billions of tablets, bottles and vials that have entered the U.S. drug supply and made their way to patients’ medicine cabinets, hospital supply closets and IV drips, a Kaiser Health News investigation shows. The recalls represent a fraction of the medicines shipped each year. But the flawed products contained everything from dangerous bacteria or tiny glass particles to mold — or too much or too little of the drug’s active ingredient.

Over the same period, 65 drug-making facilities recalled nearly 300 products within 12 months of passing a Food and Drug Administration inspection — as was the case with the stool softener, according to a KHN analysis of recall notices and inspection records kept by the FDA.

Those recalls included more than 39,000 bottles of the HIV drug Atripla laced with “red silicone rubber particulates,” nearly 37,000 generic Abilify tablets that were “superpotent,” and nearly 12,000 boxes of generic Aleve (naproxen) that were actually ibuprofen, according to the recall data KHN examined.

The medicine alleged to have sickened Anderson Moreno seriously infected at least 63 other people in 12 states, according to reports by the FDA and Centers for Disease Control and Prevention. The drug was made at a PharmaTech plant in Broward County, Fla. That same plant passed an FDA inspection even while it was making bacteria-laced products, according to a KHN review of the inspection records.

PharmaTech did not respond to KHN’s requests for comment. A lawyer for the drugmaker filed a motion to dismiss the lawsuit in April, but it was not granted. In follow-up court records, PharmaTech has denied claims against it.

Like other FDA commissioners before him, Scott Gottlieb has called his agency’s drug oversight program the “gold standard” for safety and effectiveness.

But veteran industry consultant John Avellanet, who has trained FDA inspectors, questions how effective the FDA’s drug plant inspections actually are. “It’s so easy” for FDA inspectors to miss things because they’re working with confusing regulatory terms and standards that are often decades out of date, Avellanet said.

Just how often people are sickened or die from tainted drugs is next to impossible to determine. No government agency tracks cases unless they’re linked to a major outbreak among hospital patients. And sudden, seemingly random illnesses in disparate places are notoriously hard to link to a tainted drug. That’s in part because drugmakers don’t have to divulge which products are made in which manufacturing plants, since that is regarded as proprietary information.

The result: Even someone who buys drugs for a major hospital can’t track down where a potentially dangerous product came from, said Erin Fox, who purchases medicines for University of Utah Health hospitals.

“Patient safety should come first,” she said, adding that the KHN analysis indicates “our drug quality is probably not what we think it is,” and calling it a “scary” reality. “Something does need to change if this is happening this many times and we’re having patients receiving contaminated products.”

The FDA declined to be interviewed for this story, but responded to written questions.

“While the FDA would prefer that no drug be distributed that later is recalled, we do not think that a recall indicates a failure of FDA inspection and surveillance programs,” FDA spokesman Jeremy Kahn said in an email. He said inspectors “may not uncover all issues or practices that may eventually result in a problem leading to a recall” and that “not all recalls are the result of poor manufacturing practice.”

The PharmaTech Story

“Lucky fin, lucky fin, lucky fin,” Alicia Moreno, 30, cheered as she untangled her now 3-year-old son’s stroke-weakened arm from a sweater and his portable ventilator in the back seat of the car for yet another four-hour drive to see doctors in Ann Arbor, Mich. In the Disney movie “Finding Nemo,” Nemo’s father calls the young fry’s smaller fin his “lucky fin.”

While her husband drives, Alicia pulls out a clear plastic case of syringes and watches the clock on the dashboard. Anderson needs about two dozen different medicines every 24 hours, and Alicia administers them via a port in his belly at designated times.

Alicia Moreno spends the day with her son, Anderson.(Heidi de Marco/KHN)

It wasn’t always like this. Anderson appeared healthy until his 6-month checkup in May 2016, his mother said. Partway through the exam, the Morenos rushed their baby to a nearby hospital and learned he was in heart failure and would need a transplant to survive. That’s where he received the tainted stool softener, his lawyers allege. The hospital where Anderson eventually received his transplant confirmed via email that Anderson tested positive for the same strain of B. cepacia involved in the outbreak traced back to PharmaTech’s contaminated drug.

In July, according to the family, Anderson started to have difficulty breathing and his temperature spiked to 106 degrees, which landed him in the ICU, where doctors and nurses packed him with ice and rushed to find the cause. Their tests turned up positive for B. cepacia, a bacterium found in untreated water that doesn’t typically make healthy people sick. Anderson’s status on the transplant list was put on hold, and his heart condition worsened. He was placed on a machine that transferred blood outside his body, oxygenated it and pumped it back in.

Anderson finally got a heart transplant in November 2016, but four days after doctors closed his chest, his fever was back and his lungs kept getting worse, requiring more complicated machinery. Tests came back positive for a flu-like virus and B. cepacia, according to the hospital.

“Where did he get it?” his parents pleaded. At the time, no one knew.

Anderson Moreno uses a portable ventilator because of his impaired lung capacity.(Heidi de Marco/KHN)

The Moreno family makes the four-hour drive home from C.S. Mott Children’s Hospital in Ann Arbor, Mich., where doctors checked Anderson’s lungs, kidneys and other systems in back-to-back appointments.(Sydney Lupkin/KHN)

How Tainted Drugs Slip Through the Cracks

The FDA is supposed to inspect all factories, foreign and domestic, that produce drugs for the U.S. market. But a KHN review of thousands of FDA documents — inspection records, recalls, warning letters and lawsuits — offers insight into the ways poorly manufactured or contaminated drugs reach consumers: Inspectors miss serious hazards. Drugmakers fail to meet standards even after the FDA has taken enforcement action. Hundreds of plants haven’t been inspected for years, if ever.

Last July, for example, the FDA announced the first of many voluntary recalls of the blood pressure medicine valsartan because some tablets contain a cancer-causing impurity called N-nitrosodimethylamine (NDMA). They would later find a similar carcinogen, N-nitrosodiethylamine (NDEA), in valsartan pills. Over the prior two years, investigators had detected worrisome problems in two overseas factories involved in the manufacturing of the drug.

In 2017, FDA investigators found rust, chipping paint and deteriorating equipment at a plant run by Zhejiang Huahai Pharmaceutical Co. in Zhejiang, China. Plant staffers weren’t properly testing and investigating “anomalies” in their drugs, dismissing problematic test results, the FDA said at that time. Inspectors also found “black metallic particles” and other problems in some unidentified drugs.

The FDA inspected the plant in July 2018 after complaints about NDMA from a facility further down the drug supply chain. The FDA put the facility on import alert in late September and issued a warning letter in November detailing deficiencies, including “Failure of your quality unit to ensure that quality-related complaints are investigated and resolved.”

At a facility of Hetero Labs in India, in 2016, FDA inspectors found colored and white residue in components, some of the factory’s tablets were twice as thick as others, and employees were shredding documents in the middle of the night. The FDA issued a warning letter to the company as a result of the inspection.

Plants making drugs for U.S. consumers are supposed to be inspected every few years, according to a risk-based system. However, in the past decade more than 2,500 facilities, both foreign and domestic, have gone more than five years without an FDA drug-quality inspection, a KHN analysis found. The FDA has no drug-quality inspection records over the past decade for more than 1,200 domestic plants and nearly 400 foreign plants, excluding those that make animal drug products, according to the analysis. Gottlieb said in December that he hopes to clear the backlog of uninspected drug facilities by the end of September 2019.

At best, the inspections are a snapshot in time, and involve looking at processes rather than evaluating the drugs themselves, said drug-quality specialist Dinesh Thakur, who has worked for drugmakers. The inspections might take place while the facility is making only one of a dozen or so drugs that it usually manufactures.

“The implicit assumption … is that if the [manufacturing] processes are sound, the product will be of good quality,” said Thakur, who raised the alarm about quality-control problems at generics drugmaker Ranbaxy, resulting in a 2013 guilty plea and a $500 million settlement. “Your data tells us this is not true.”

Many inspections, he said, are “stage-managed,” so that factories pass on the appointed day, but “once the inspectors leave, it’s a completely different story.”

David Gortler, a former FDA medical officer, said most drug plant inspections involve looking over paper records and trusting that they’re real, instead of randomly testing medicines.

“Anybody can write down anything on a piece of paper,” said Gortler, who is now a consultant at FormerFDA.com. He added that FDA inspectors aren’t reprimanded — or even told — if they’ve passed a plant that issued a recall shortly thereafter.

A sign on the Morenos’ front door asks visitors not to enter if they have recently been sick.(Heidi de Marco/KHN)

A tray of syringes sits on the kitchen countertop. Anderson needs about two dozen different medicines every 24 hours, says his mother, Alicia.(Heidi de Marco/KHN)

Alicia administers Anderson’s medicines via a port in his belly at designated times.(Heidi de Marco/KHN)

A Lucky Break Solves A Mystery

The contaminated stool softener alleged to have sickened Anderson Moreno was one of many drugs recalled by plants shortly after they passed an FDA inspection. The bacteria was detected only after an outbreak of disease — and after a good deal of medical sleuthing.

More than 1,000 miles away from Anderson’s ICU bed in Michigan, staff at Texas Children’s Hospital’s pediatric ICU in Houston had diagnosed three cases of B. cepacia in one week in February 2016, according to a 2017 medical journal article published in Infection Control and Hospital Epidemiology. It was odd because there had been no cases the previous year.

Hospital staff members embarked on a months-long investigation and by July had identified 24 victims, whose median age was under 2 years old. Patients had the same strain of the bacteria in their blood, their respiratory tracts, their urine or their stool, according to the article.

Samples matched the bacteria found in liquid docusate, the stool softener, the researchers wrote.

The hospital alerted the CDC and other public health officials of its findings. The CDC would eventually identify 63 confirmed and 45 suspected serious B. cepacia infections in 12 states tied to the contaminated drug.

A 36-day FDA inspection of PharmaTech in Davie, Fla., that ended Aug. 9, 2016, revealed that the bacteria was in water used to clean equipment and make liquid products. FDA inspectors concluded that the bacterium made it into the facility’s drugs starting in 2015 and was still present in the water.

Anderson was treated with the stool softener in May 2016. His parents filed suit in September 2017 in PharmaTech’s home of Broward Country, Fla., against the drugmaker and others in the drug supply chain, alleging the drug was contaminated and caused him grievous damage. PharmaTech, which did not return KHN’s requests for comment, unsuccessfully filed a motion to dismiss and has denied all charges in a subsequent filing.

A 9-month-old girl in Pittsburgh who had received the stool softener died on May 4, 2016, according to a lawsuit her family filed in July 2017 in the U.S. District Court for the Western District of Pennsylvania. Her mother learned about the drug recall by chance and asked the hospital whether her deceased daughter received the tainted drug, her lawyer told KHN. The family filed charges against PharmaTech and others in the drug supply chain in a wrongful death lawsuit. The court rejected PharmaTech’s motions to dismiss and strike, and the drugmaker denied liability in a subsequent filing. In November 2017, a lawyer representing PharmaTech in that wrongful death case told the Orlando (Fla.) Sun Sentinel that it will defend itself against the allegations and couldn’t comment further “because of the ongoing nature of litigation.”

According to federal records, FDA inspectors had a chance to catch the contamination during their March 2016 inspection, but the PharmaTech plant passed with no citations. PharmaTech CEO Ray Figueroa saluted the inspection results in a press release, calling it “a testimony to PharmaTech’s commitment to world-class quality.”

How Things Can Go Wrong

The FDA has issued thousands of enforcement actions against drug plants over the years, citing safety violations, issuing warning letters and blocking imports from certain foreign plants. In rare cases, the FDA can also seize drug products and has done so 23 times in the past decade. The last drug seizure was more than two years ago, according to FDA records.

In an emailed statement, FDA chief Gottlieb said the FDA is “taking new steps” to identify problems before they occur and it is “not shy” to use its powers to mitigate risks.

But the system can be stymied or gamed and the FDA’s enforcement abilities are limited. For instance, it doesn’t have the power to issue a mandatory recall, and manufacturing citations don’t come with fines.

Many cases come to light only when a whistleblower sounds an alarm.



Thakur, the Ranbaxy whistleblower, said officials in other countries sometimes tip off plants about “surprise” FDA inspections. And FDA inspectors often have to rely on translators hired by the drug companies, said Avellanet, who has been a drug facility inspection consultant for more than 20 years.

At Nippon Fine Chemical in Japan, employees stood “shoulder-to-shoulder” to keep an FDA official out in December 2015, according to an enforcement letter sent to the plant and published online.

Less than a year later, Vikshara Trading & Investments Ltd. in India allegedly faked a worker strike to block the entrance to the plant, according to an FDA enforcement document that described the manufacturer’s “false statements.” When inspectors were eventually allowed in, the lights were kept off.

“Our investigator had to perform parts of the walkthrough in the dark, using a flashlight,” the FDA warning letter reads, adding that an unidentified powder was “scattered” and “caked on the floor” in production areas and detected on finished drug products.

Two former employees have filed a whistleblower suit against Gilead Sciences, alleging it lied to the FDA about using a drug-manufacturing facility in South Korea, when it was actually using an unregistered facility in China. According to the civil complaint filed in September 2014 in U.S. District Court for the Northern District of California, the ingredient produced at Synthetics China and used in HIV drugs Truvada and Atripla contained “glass-like shards,” “black rubber-like particles,” “plastic-like particles,” “small stone or pebble-like particles” and “metal shards.”

The whistleblowers alleged Gilead’s Alberta, Canada, plant was tasked with sieving contaminants and helping to conceal where the ingredient was made.

They said one batch of the ingredient was contaminated with arsenic, chromium and nickel. Another had a dangerous bacterium called Bacillus cereus, according to the whistleblowers’ suit. Still, Gilead released the product and didn’t initiate a recall, the whistleblowers alleged.

Years after the whistleblowers stopped working for Gilead, the drugmaker issued two voluntary recalls of HIV drugs in 2014, about seven months apart. Both recalls cited contamination with red silicone rubber particulates.

Gilead declined to comment. Gilead has fought the lawsuit, alleging that since the government knew of the allegations and did not penalize it by denying drug approvals or payments, the suit could not move forward. In 2015, a federal judge dismissed the case, but a panel from the 9th District Court of Appeals reversed that decision in 2017. Now the Supreme Court may hear it; in April 2018, it invited the solicitor general to file a brief, “expressing the views of the United States.” The Justice Department filed a brief in November, saying pursuing the lawsuit is “not in the public interest.”

Since the FDA has little power to force a drugmaker to fix problems or issue recalls, FDA inspectors often flag the same violations again and again. A KHN analysis found that over the past decade 70 drug plants — most of them domestic — were penalized for the same violation at least four times. And more than a third of those plants has issued a recall at some point.

Altaire Pharmaceuticals in New York was cited five times by FDA inspectors for inadequate “procedures for sterile drug products.” In 2013, it recalled 363,746 bottles of generic eye drops sold at CVS, Target and Walmart over sterility concerns — namely mold — because the preservative in the product “may not be effective” through the expiration date. Overall, Altaire was told to correct 15 violations at least twice.

KHN attempted to contact Altaire Pharmaceuticals, but the company did not reply.

Kept In The Dark

About a year after the initial PharmaTech recall in 2016, the FDA announced another recall for the same drugs and the same bacterium: B. cepacia. When Erin Fox saw the second recall, she thought it was a mistake. The alert said to avoid drugs made by PharmaTech under several labels “and possibly [products from] other companies.” What other companies? Fox wondered. How could they not know which ones?

Doctors at the hospital asked Fox to remove all PharmaTech-made products from the shelves, but because of lax labeling laws, she said, she couldn’t be sure which those were. Drug labels need to include only the manufacturer, the packer or the distributor — not all three — so the doctors suggested she call PharmaTech and ask what else it manufactures and for whom.

“Of course,” Fox said, “they wouldn’t tell us.”

Methodology

To analyze the inspections and recalls of plants that manufacture drugs, KHN started with two Food and Drug Administration databases of drug recalls: one at OpenFDA, and one on the FDA’s recall data dashboard. The first provided details about drugs, dates and quantities recalled, and the second provided a recalling plant ID, called an FEI. We used them both to create a more complete recall database.

The FEIs served as a bridge between the recalls data and two inspection data tables. Both tables contained inspection dates and purposes, but one listed inspection grades and the other contained a list of citations. Combining inspection and recall databases allowed us to find the most recent inspection at each plant that preceded a recall, and to determine its grade. It also allowed us to count repeat citations and determine whether plants that received them ever initiated a recall.

To determine whether plants had not been inspected in the past decade, we compared our inspections data to the Drug Establishments Current Registration Site database, which contains all registered operating plants. We excluded plants that made products for animals and those that didn’t explicitly “manufacture” drugs, according to the database. The FDA has said there may be a delay in adding inspections to its database after they are completed.

Our data is current as of early October 2018. We included only inspections categorized as “drug quality assurance” inspections throughout the analysis.


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.