Tagged Hepatitis

State Prisons Fail To Offer Cure To 144,000 Inmates With Deadly Hepatitis C

State prisons across the U.S. are failing to treat at least 144,000 inmates who have hepatitis C, a curable but potentially fatal liver disease, according to a recent survey and subsequent interviews of state corrections departments.

Many of the 49 states that responded to questions about inmates with hepatitis C cited high drug prices as the reason for denying treatment. The drugs can cost up to $90,000 for a course of treatment.

Nationwide, roughly 97 percent of inmates with hepatitis C are not getting the cure, according to the survey conducted for a master’s project at the Toni Stabile Center for Investigative Journalism at Columbia University’s Graduate School of Journalism.

Advocates say this ignores a 1976 Supreme Court ruling that determined an inmate’s medical care is a constitutional right.

“It doesn’t make sense to wait now that we have the effective cure available,” said Dr. Raymond Chung, director of Hepatology and the Liver Center at Massachusetts General Hospital. Chung was a former co-chair of the American Association for the Study of Liver Diseases and the Infectious Diseases of America’s HCV guidance panel, which recommends everyone with chronic hepatitis C have access to the cure.

Corrections departments in all 50 states and the District of Columbia were asked how many inmates have hepatitis C, how many are treated, what drugs are used for treatment, and what policies exist concerning inmates with the virus. Almost all of the states responded with some or all of the information requested. South Carolina and D.C. denied the requests.

With more than 1.3 million inmates, state prisons house the largest group of incarcerated people in the country — people with a higher risk of passing the bloodborne virus by sharing needles, razors or toothbrushes. The infection rate is much higher among the incarcerated than the general population, partly because nearly one-sixth of state prisoners are serving for drug offenses.

The vast undertreatment comes at a time when the infection rate for hepatitis C, or HCV, has been increasing in part due to the opioid epidemic.

Some prisons ignore their own guidelines for standards of care. In Florida, at least 181 inmates who met the criteria for treatment did not get the cure, according to records kept by the Florida Department of Corrections. The department has a 13-page policy that says prisoners are eligible for HCV therapy when the disease reaches Stage 2, which is when the liver shows mild to moderate fibrosis, or tissue scarring.

“The Department is committed to ensuring all inmates in our custody are provided medically necessary treatment that is in line with national standards and our constitutional responsibilities,” Ashley Cook, press secretary of the Florida prison system, said in an email.

Since late 2013, new hepatitis C drugs with a success rate of more than 95 percent have become available. But they come with sticker prices of $40,000 to $90,000 for the daily tablet regimen of eight to 12 weeks. These drugs replaced previous therapies that cost around $70,000 for 48 weeks of treatment with a much lower cure rate.

The Minnesota Department of Corrections treated 58 inmates from 2014 to 2016. Dr. David Paulson, medical director of the Minnesota state prison system, said his department cannot afford to do more.

“We have to operate within our means and treat the [prisoners] that are the most advanced first,” he said in an interview. “When prices go down, we will treat more people.”

In California, state officials have allocated $106 million in next year’s budget to treat inmates with hepatitis C.

Gilead, one of the companies that make the drugs, which include its popular brands Sovaldi and Harvoni, says patient access is among its top priorities.

“Gilead provides public and private payers substantial discounts and is committed to working with individual state departments of corrections to help ensure patients receive the treatments they need,” Mark Snyder, public affairs director, wrote in an email.

In 2016, Gilead said in a statement to the BMJ medical research journal that it would “stand behind the pricing” of its antiviral drugs because it would pay off in the long run, compared to “the long-term costs associated with managing chronic HCV.”

Another drugmaker, AbbVie, said the company’s latest HCV drug, Mavyret, is significantly cheaper than all the drugs that came before it could expand access.

“We continue to work with payers, plan benefit managers and providers to ensure patients have access to the appropriate HCV therapy,” said Raquel Powers, AbbVie’s public affairs director.

The HCV drugs in 2016 cost more than $50,000 per treatment course per inmate with some discount, according to Brandon Sis, senior pharmacist for corrections at the Minnesota Multistate Contracting Alliance for Pharmacy, which negotiates drug discounts for various agencies nationwide, including 15 departments of corrections. Sis said that the discounted price of the HCV drugs available to state prisons has since been cut by about half, to about $25,000 per treatment course at the end of 2017.

“This is a treatable condition. No one should die from HCV,” said Michael Ninburg, president of the World Hepatitis Alliance and executive director of Hepatitis Education Project, an advocacy group for people affected by the disease.

Barry Michaelson, a former Minnesota inmate, and Terry Riggleman, a current prisoner in Virginia, were among the untreated despite making several requests for the cure.

Over the course of their sentences, both felt their health deteriorating and were increasingly exhausted. Michaelson said he had frequent headaches and had white lesions and hard bumps on his skin. Riggleman said he felt constant pain in his abdomen and joints. Those symptoms are common as the disease progresses.

“We’re sick, and they’re doing nothing about it,” Michaelson said.

In Minnesota, where Michaelson was incarcerated, only 22 inmates had received the treatment during the first 10 months of 2017, the survey found.

“If we treat everybody with hepatitis C, it would exceed the entire total pharmaceutical budget for everything else and there would not be enough budget left to treat patients with other diseases,” Paulson said. “We need to do what brings the greatest benefit for the greatest number of people.”

According to Paulson, 15 percent of inmates, or around 1,500, in Minnesota state prisons were HCV-infected in 2017. If the department were to treat every inmate, it would have cost more than $75 million, far exceeding its $27 million budget for all health care.

“We need to look at the entire picture. The goal, my goal at least, is to offer treatment based on the risk of the adverse effects of hepatitis C,” said Paulson, who wrote a book on hepatitis C in 2000. “Ideally, we would treat everybody if it’s $50 a pop.”

The constitutional argument over treatment revolves around the Eighth Amendment prohibition of “cruel and unusual punishments.” Inmates have nowhere else to turn for health care. States restrict or prohibit any private or outside medical care.

“I’m in a position where I can’t help myself,” Riggleman said in an interview at the Augusta Correctional Center in Virginia.

“The cost isn’t an argument,” said Michaelson. “Once you’ve incarcerated people, you have to take care of them.”

Michaelson and Riggleman separately filed class-action civil rights suits against their states’ prison systems for not treating inmates with hepatitis C. Michaelson’s suit, assisted by outside counsel, was the country’s first suit of its kind and Riggleman’s was one of the most recent.

“The law is clear that we have the right to medical care,” Michaelson said. “So they have to treat us. No excuses.”

The litigation over this issue is ongoing in Minnesota and Virginia and in at least seven other states, including Alabama, California, Colorado, Florida, Missouri, South Carolina and Tennessee.

Approximately 640,000 inmates are released nationwide each year, and that means there could potentially be more than 75,000 HCV-infected people entering the general population annually. Those who didn’t get tested, or treated, while incarcerated would increase the risk of new infections.

“It’s very unfortunate that any person that could potentially be cured is not being treated,” Chung said in an interview. “It’s even more regrettable that we can’t treat persons who are at high risk of transmitting the virus to others.”

“From a public health standpoint, this is a disaster,” Paulson said. “If the court rules that the department has to treat everyone, that money has to come from the state legislature. That would be the money that would have been spent on roads, bridges, schools and child protection services.”

Michaelson was released from his Minnesota prison in March 2017, without getting any treatment for hepatitis C, almost seven years since his diagnosis. While locked up, he’d lost 20 pounds, so his old clothes hung loose from his body. He left the prison with two cardboard boxes full of papers from his legal research. Since he was no longer incarcerated, his name was removed from the lawsuit. A trial is expected to start in September.

Riggleman, who was diagnosed 14 years ago and will not be released for another 10 years, still awaits treatment.

“I don’t have a life sentence. I got people that I care about and I want to fix things. I want to live. I wasn’t sentenced to death. Don’t let me die in here.”

Thanthong-Knight reported this story as part of his master’s project for the Toni Stabile Center for Investigative Journalism at Columbia University Graduate School of Journalism.

Methodology

The figures in this story came from a survey sent to the departments of corrections in 50 states and the District of Columbia, between October 2017 and March 2018. Some states responded to the survey without FOIA or Open Records requests, and others required a formal request.

The survey asked for: (1) the state prison policy on testing and treating HCV, (2) the HCV drugs in their formulary, (3) the number of inmates with HCV, or the prevalence rate of HCV in the state prisons, and (4) the number of inmates with HCV who were treated in the previous year, or the most recent data available. For states that required records requests, a question about the amount of budget spent on treating inmates with HCV was added to the survey.

All of the states and D.C. responded to the survey in some form. As of publication, 45 states had given complete answers for both the numbers of inmates diagnosed and treated. Arkansas, Hawaii and Missouri responded only to either the prevalence rate or the number of inmates treated. South Carolina and D.C. denied the FOIA requests.

The overall numbers are estimates, and some states provided only estimates. Additionally, not every state prison performed testing during intake or does routine testing. For example, Georgia tested only 4 percent of its inmates but reported that 727 inmates have HCV, meaning that almost 1 in 3 of the people who were tested had the virus.

The policies on testing and treating varies greatly by state; some are more restrictive than others in terms of treatment eligibility, giving access to those in advanced stages of disease. Alaska, Georgia, Maine and South Dakota did not have clear written rules for testing or treating HCV. Mississippi had a policy that dated to 2005, almost a decade before the current drugs were introduced.

The current HCV medications come in at least eight brands. Not every prison system had these treatments in their formularies; physicians prescribing non-formulary HCV drugs need approval from the department of corrections. At least nine states did not include any of the HCV drugs in their prescription lists.


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

Think Like a Doctor: The Tired Gardener Solved!

On Thursday, we challenged Well readers to solve the case of a previously healthy 67-year-old gardener who abandoned his garden one summer, alarming his wife and adult children. For weeks this vibrant and energetic man had been the last one out of bed — something his family had never seen before. And his days were interrupted each afternoon with a fever that left him shaking and pale. More than 300 readers suggested diagnoses for this classic presentation of an unusual disease, and a couple dozen of you nailed it.

The correct diagnosis is…

Babesiosis

The first person to identify this unusual infection was Dr. Paige Szymanowski, a resident in her second year of training in internal medicine at the Beth Israel Deaconess Medical Center in Boston. She said she recognized the pattern of a fever with a low blood count, low platelet count and evidence of liver injury. Dr. Szymanowski hasn’t made up her mind what kind of doctor she’s going to be, but she is thinking of subspecializing in infectious diseases. I think she shows real promise in this area. Well done!

The Diagnosis

Babesiosis is caused by the parasite Babesia microti, a protozoa. It is usually transmitted by Ixodes scapularis, better known as the deer tick, the same small arthropod that transmits Lyme disease. Sometimes the two diseases occur together, passed on in the same bite. The disease can also be spread through blood transfusions from an infected donor.

Babesiosis is rare and occurs primarily in the Northeast and Upper Midwest — Minnesota and Wisconsin — regions of the United States. In healthy people it often causes no symptoms. However, those who are over 65 or who have some type of immune suppression – because of a chronic disease or medication – or those who don’t have a spleen are more likely to develop symptoms and can become quite ill or even die from this infection.

Easy to Miss

Babesiosis is difficult to diagnose, and the diagnosis is often overlooked, even in areas where infection is most common. Patients with babesiosis have few, if any, localizing signs to suggest the disease. Fever — which can be constant or, as was the case with this patient, intermittent — is common. So are shaking, chills, fatigue, loss of appetite, abdominal pain and headache. These symptoms, however, are seen in many infections. And indeed, our patient had all of these symptoms, but it took many weeks for him to get a diagnosis.

The diagnosis is confirmed when the ring form of the protozoa is seen on a blood smear, or when the Babesia DNA is detected in the blood. Doxycycline, which is used to treat other tick-borne diseases, is ineffective against this organism. An antimalarial medication (atovaquone) plus an antibiotic (azithromycin) are first-line treatments against this infection. Improvement is usually seen within 48 hours of starting the drugs.

Although the infection will often resolve without treatment, all who are diagnosed with the disease should be treated since, in rare cases, the bug will persist and become symptomatic if a patient later develops some immune system problem or has his spleen removed.

How the Diagnosis Was Made

Dr. Neil Gupta was leading the daytime on-call team at Saint Raphael’s hospital in New Haven, Conn., where the patient’s daughter had taken him. Dr. Gupta heard about this patient when the night team handed off the patients they had admitted on their shift and met him that morning. Seeing how well the patient looked, and hearing that he’d been given the usually benign diagnosis of hepatitis A, he turned his attention to patients who seemed sicker and more in need of thought and care. Until the patient spiked his usual afternoon fever.

One of the ways the doctor’s mind works is to put together pictures of what a disease looks like in a patient. We put these so-called illness scripts together based on our knowledge of the disease plus the patients we have seen who have had it.

When Dr. Gupta heard that the patient had spiked a temperature, he went back to see how he was doing. The patient was pleasant but didn’t say much. Perhaps there was a language barrier — he spoke with a thick Italian accent. Or perhaps he was one of those patients who just don’t focus on what ails them.

Hearing From the Patient’s Family

The patient’s wife and daughter, however, had been much more attuned to the changes in his health and behavior, and what they reported didn’t really sound like hepatitis. Was this the right diagnosis, Dr. Gupta wondered?

He sat down with the family in the nursing lounge and let them tell the whole story as they recalled it. The man had actually been sick for several weeks. He’d had a fever every day. And he was tired. Normally he never sat down, was never idle. These days it seemed he never left the house anymore. Never went into the garden. He just sat on the sofa. For hours.

Sometimes he had pain in his upper abdomen, but never any nausea; he had never vomited. But he did have a cough. This was not the man they knew, the women told him.

Reviewing the Symptoms

Dr. Gupta returned to the patient and examined him, this time quite carefully, looking for the signs common in hep A. The man’s skin was dark but not yellow; and his eyes, while appearing tired, showed no hint of yellow either. His liver was not enlarged or tender. He didn’t look to Dr. Gupta like a patient who had hepatitis A.

The patient did have tests that were positive for hepatitis A, however. Could these tests be wrong? Dr. Gupta suspected that was the case. O.K., if not hepatitis A, what did he have?

The young internist made a list of the key components of the case: He had recurring fevers every afternoon. He had a cough and some upper abdominal pain. Not very specific — except for the repeating fevers.

The labs were a little more helpful. His liver showed signs of very mild injury — again, not consistent with hepatitis A, which usually causes significant liver insult.

However, he did have a mild anemia that had gotten worse over the past three days. He’d had his blood count drawn two days earlier, when he went to the emergency room at Yale–New Haven Hospital. That showed a very mild anemia – slightly fewer red blood cells than normal. The evening before, the patient’s red blood cell count had dropped further. And today, even further. So his red blood cells were being destroyed somehow. To Dr. Gupta, that seemed to be a second important clue. In addition, his platelets were quite low.

Many Possiblities

So, the patient had cyclic fevers, a worsening anemia and a mild liver injury. That suggested a very different set of diseases.

The patient was a gardener and had been treated for Lyme disease. Could he have a different tick-borne illness?

Certainly a number of illnesses could present this way. The cyclic fevers were suggestive of malaria — rare in this country, but still worth thinking about.

Could this be mononucleosis? Or even H.I.V.? Those diseases can affect red blood cells and the liver. And they can last weeks or months. If those tests were negative, he would need to start looking for autoimmune diseases or cancers.

Finally, he would need to review the blood smear with the pathologist. Several of these diseases can provide clues when you look at the blood itself.

An Answer in the Blood

A call came to Dr. Gupta late the next day. The pathologist had tested the patient’s blood for the presence of the Babesia gene, and found it. The patient had babesiosis.

Dr. Gupta went down to look at the blood smear with the pathologist. There, in the middle of a sea of normal looking red blood cells, was a tiny pear-shaped object. It was one of the protozoa.

Dr. Gupta was excited. He pulled up a picture of the tick that spreads the disease and the tiny bug that causes it to show to the family. This was what was making the patient so very sick.

How the Patient Fared

The patient was started on the two medications to treat babesiosis the same day. Twenty-four hours later he spent his first day completely fever-free —the first in several weeks.

After a couple more days, the patient was up and walking around, asking to go home. He went home the following day, with instructions to take his two medications twice a day for a total of 10 days.

That was last summer. This summer, the patient is back in his garden. He is a little more careful to avoid getting tick bites. He wears his long pants tucked into his socks and his wife looks him over every night — just to be sure.

Think Like a Doctor: The Tired Gardener

The Challenge: Can you figure out what is wrong with a lively 67-year-old gardener who develops a daily fever and shaking chills along with chest pain and a dry cough?

Every month, the Diagnosis column of The New York Times Magazine asks Well readers to solve a real-life diagnostic mystery. Below you will find the details of a case involving a retired maker of surgical supplies who starts having daily fevers along with chills, chest pain and a dry cough.

I’ll give you the same information the doctor was given before he made this diagnosis. Will you be able to figure out what’s wrong?

As usual, the first reader to submit the correct diagnosis gets a signed copy of my book, “Every Patient Tells a Story,” and the pleasure of puzzling out a tough but fascinating case.

The Patient’s Story

“NoNo says he doesn’t feel good,” the 9-year-old girl said of her grandfather, handing her mother the thermometer. The woman dried her hands on her apron and took the device. She squinted at the little electronic numbers. Just under 102 degrees.

Her father had been sick for weeks. Feverish, weak, not eating. It was late summer and the tomatoes and eggplants in the garden were ripe, but he hadn’t even walked through his garden for days, so she knew he wasn’t feeling well. But this was the first time he’d admitted that something more serious might be going on.

It was about time. She’d taken her 67-year-old father to several doctors over the past two months. They’d looked him over and given him antibiotics, but it hadn’t helped.

“Tell NoNo that if he’s feeling sick he’s got to go to the hospital,” she told the little girl. She darted back to her grandfather’s room then quickly returned. “He says he’s ready to go.”

The woman wasn’t sure exactly when her father had started to get sick, but six or seven weeks earlier she had noticed that he was no longer the first one out of bed. Instead of being up and out before 7 a.m., he wouldn’t get up until late morning. And he started to have strange shaking chills each afternoon and evening, followed by a fever — regular as clockwork.

He looked sweaty and pale. She asked him what was wrong, but he said he was fine. Or sometimes he’d say he felt a little tired. After an hour or two the fever would pass and he’d just look tired, but the next day, or sometimes the day after, the fever would be back.

The First Diagnosis

The woman first took her father to his regular doctor. Knowing how much he loved to work in his garden, the doctor figured he probably had Lyme disease. It was summertime, and Lyme was common in the area of Connecticut where they lived. Plus, he practically took root in the half-acre garden back behind the house where he lived with his wife and their children and grandchildren.

This was the first summer the woman could remember where her father wasn’t out in his garden every single day. This year it seemed that whole weeks would go by when he did nothing but look out the window at his beautiful handiwork.

Her father took antibiotics for the presumed Lyme. It didn’t help.

A Second Diagnosis

When the patient went for a follow-up visit, he told his doctor that his stomach was bothering him a bit. So he was referred to a gastroenterologist. That doctor diagnosed Helicobacter pylori – a bacterium tough enough to survive the acid environment of the stomach that can cause pain and ulcers.

He took two weeks of treatment for that — three medications to kill the bug, and one to neutralize the acid they thrive in. That didn’t stop the daily fevers, either.

Recently the man’s wife noticed that he’d developed a dry cough. Was this a pneumonia? His doctor gave him yet another antibiotic. And he was still taking that pill when he agreed to go to the emergency room.

Pneumonia?

So three generations — wife, daughter and granddaughter — got in the car with the man they loved and drove to the hospital where the daughter worked.

The emergency room was quiet when they arrived, and after explaining that the patient had been having fevers for weeks, the patient and his entourage were taken into the back so he could be seen right away.

He did have a fever but otherwise looked pretty healthy. The doctors there seemed to focus on the cough and fever. They figured he had a pneumonia that wasn’t responding to the antibiotics he was taking. And when a chest X-ray failed to show any sign of pneumonia at all, the doctors sent him home.

You can see the note from that first visit to the Emergency Department here.

First ER Visit

If Not Pneumonia, Then What?

The next day, the man felt no better. His daughter was distressed. Her father was sick. Antibiotics weren’t working. And he was getting worse.

She called his primary care doctor again. He was also worried, he told her. But he didn’t know what to suggest.

What if she tried a different emergency room?, she suggested. They had gone to Yale-New Haven Hospital initially because that’s where she worked, but what if they went to the smaller branch of the hospital, St. Raphael’s Hospital, less than a mile away. They had different doctors there, and the hospital had a different feel — local and friendly rather than big and academic. Maybe they would find a doctor there who could help them figure out what was going wrong. It was unorthodox, the doctor told her, to shop around emergency rooms. And it wasn’t clear what another E.R. visit might do. But he was also worried about the patient, and it was certainly worth a try.

Another E.R. Visit

So early that evening they all got back into the car and drove to the St. Raphael campus. The E.R. was bustling when the family came in. Once again he had a fever – 101.6 degrees. His family explained how sick he’d been, how tired. And yet when the doctor examined him, he seemed well enough. He couldn’t find anything abnormal beyond the fever.

The labs told a slightly different story. His red blood cell count was low. So were his platelets – a type of blood cell that helps blood to clot. What was particularly strange was that these two findings had been checked the day before at the other E.R. and had been fine. And there was some evidence that he had some liver damage.

And when tested for viral hepatitis — a common causes of abnormal liver tests — he tested positive for hepatitis A and possibly hepatitis B as well.

He was admitted to St. Raphael’s Hospital because of his worsening anemia and viral hepatitis.

You can see the note from this second emergency room visit, and the admission note from the night team here.

The Second ER Note

Admission Note

Fitting the Pattern

The next morning, Dr. Neil Gupta saw the patient. Hearing the patient’s story, and the diagnosis of hepatitis A infection, was a little puzzling. Patients with hepatitis usually have mild flu-like symptoms, with a loss of appetite, nausea and vomiting, plus fatigue, low-grade fever and a generalized sense of being unwell. Certainly this patient didn’t feel well, but he had no nausea, no vomiting. And his fever came in spikes. The pattern didn’t really match.

Dr. Gupta sat down with the patient’s family and reviewed all the symptoms and the timeline. Then he reviewed all the labs. He sent off a bunch of tests.

You can see Dr. Gupta’s note here.

The Doctor’s Note

Solving the Mystery

Dr. Gupta was finally able to figure out what was wrong with this man. Can you?

The first person to figure out what is really going on with this 67-year-old gardener gets a copy of my book and that lovely sense of satisfaction that comes from making a tough diagnosis.

Rules and Regulations: Post your questions and diagnosis in the comments section below. The winner will be contacted. Reader comments may also appear in a coming issue of The New York Times Magazine.