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Wednesday, April 10, 2019

New cures for hepatitis C — but are they affordable

When a baby is sick with fever, cough, and a wheeze, it’s natural to think that what they need is medication — like an antibiotic, or one of the medications used to treat wheezing in children with asthma (such as albuterol). But it turns out that if a condition called bronchiolitis is the culprit, the best treatment is no treatment.

Bronchiolitis is a bad cold (caused by various viruses) that settles into the lungs. When it does, it leads to fever, lots of congestion, cough, and noisy or wheezy breathing. It’s incredibly common. In fact, one in five babies under 12 months ends up at the doctor’s office for bronchiolitis — and 2% to 3% end up hospitalized. It can be quite serious, especially when it’s caused by a particular virus called respiratory syncytial virus (RSV). While here in the US it’s rarely fatal, in other countries with fewer medical resources, thousands of babies die of bronchiolitis every year.

If it can be so serious, why do the latest guidelines say that doctors shouldn’t use antibiotics, albuterol, or other treatments? Because they don’t help — and they can have side effects that aren’t good for babies.

It’s not that we can’t do anything at all to help babies with bronchiolitis. We just need to help them in different ways.

Certain babies have a higher risk of getting really sick with bronchiolitis. Those include babies who are born prematurely, babies with lung disease or heart disease, and those who have a problem with their immune systems. For those babies, we recommend that they get a monthly shot, called Synagis, during the winter (roughly September to March) to help prevent RSV. If your baby falls into one of those categories and is less than a year old, you should absolutely talk to your doctor about this treatment.

For other babies, what we recommend is that families and caregivers use non-medical ways to help them feel more comfortable and breathe easier. They include:

    lots of fluids — dehydration can make all that congestion worse
    a humidifier, to loosen the congestion
    a bulb syringe to clear out the baby’s nose (nasal saline drops, available at any pharmacy, can help you get more out of the nose)
    acetaminophen or ibuprofen for fever.

You should always check in with your doctor if you think your baby has bronchiolitis, and your doctor may want to see the baby to be sure that it’s not something else that does need treatment. You should also call your doctor if, after being diagnosed with bronchiolitis, your baby develops

    a high fever (more than 102 degrees Fahrenheit), or a new fever after being sick for a few days
    trouble breathing that doesn’t get better with the humidifier or the bulb syringe (signs of trouble breathing include rapid breathing or sucking in around the ribs)
    a pale or blue color to the skin
    sleepiness or irritability that is much worse than normal
    refusal to take fluids, or not wetting diapers every 6 hours.

It’s most likely that these won’t happen, and that your baby will be just fine. As with so much in medicine and parenthood, what babies with bronchiolitis mostly need is lots of TLC — and some patience. For many years, there has been criticism that the rates of cesarean births are too high because higher rates have not resulted in improvements in maternal or child health.

Many expectant moms feel strongly about having a natural vaginal birth, and want to do all they can to avoid a cesarean section. But for some, a C-section may seem like a good option for a range of reasons. And for others, a cesarean may be essential to protect the health — or life — of mom and baby.

In parts of the world where C-sections are not readily available, complications of vaginal birth often lead to serious consequences, including loss of life for mother and baby. In contrast, quick access to cesareans has its own problems. Over all, cesarean delivery is a very safe procedure. But it carries higher risks than vaginal delivery, including a three-fold higher rate of infection, hemorrhage, and organ damage. It also has a longer recovery period.

So how many cesareans we’re doing is a number worth paying attention to.
Finding the optimal C-section rate

As it turns out, there is a sweet spot — a certain “rate” of cesareans needed to prevent the terrible suffering and aftermath that can occur when a baby can’t move though the birth canal, or when there’s an emergency requiring immediate delivery.

Recently, a study from researchers at Harvard Medical School and the Stanford University School of Medicine found that the ideal rate of childbirth by C-section appears to be about 19% of all births. This number is higher than previous guidelines have recommended, but lower than the rate in most US hospitals — which can be as high as 70%.

How did the researchers come to this number? They looked at C-section rates from 194 countries and compared them to maternal and infant mortality rates. Their analysis suggests that babies and mothers don’t fare better when cesarean rates are above 19%. Cesarean rates below 19% were associated with more birth-related complications and poorer outcomes.

This research also suggests that some of the reasons commonly cited for high C-section rates — moms who are older or obese, or who’ve had multiple previous births, along with doctors’ fear of being sued — may be only a small part of the bigger picture. In particular, these examples don’t account for why some doctors and hospitals simply do more (or fewer) C-sections than others do.

Dr. Neel Shah is one of the co-authors of the study and an obstetrician in my department at Harvard-affiliated Beth Israel Deaconess Medical Center. Dr. Shah has uncovered some previously unrecognized factors that help explain the variation in C-section rates. For example, his research suggests that time pressures in some hospitals may lead to more C-sections, since in comparison, vaginal birth can take a great deal of time and staff resources. Providing the clinical team with access to better data and technology can help them make better decisions based on patient volume, staffing, and the overall resources needed to support safe care.
What this means for expectant parents

If you are a healthy woman and have a low-risk pregnancy, the hospital you plan to use may determine the likelihood you’ll have a C-section more than any other factor. So find out the C-section rate at the hospital where you plan to deliver your baby. Talk to your doctor about this as well. If you are early in your pregnancy, you might opt to choose your doctor based on where he or she practices.

Finally, it’s important to remember that there are times when a C-section is the only safe way to deliver a baby. When that happens, a woman may feel a sense of loss for the birth experience she had hoped to have. But doing your homework about quality of care can help assure you that your method of delivery was determined for the right reasons. Were you watching the news on CNN recently when anchor Poppy Harlow fainted during a live broadcast? She was talking about a graphic on the screen at the time when, over a period of 10 seconds or so, her speech became halting and slurred — and then there was silence. With the graphic regarding President Obama’s approval ratings still on display, the broadcast moved on to a commercial. After a CNN colleague filled in briefly, Ms. Harlow, who is pregnant, reappeared and reassured her audience that she was fine. She explained that she got a little warm, fainted briefly, and now felt fine. She finished up the show and promptly reported to her doctor. A short while later, she tweeted that she and her baby were fine.

The video of the show has been widely circulated. It’s not every day that you can watch (or hear) someone pass out on live television. But did you ever wonder just what fainting is?
Fainting is not just one thing

As the term is commonly used, fainting is a sudden and temporary loss of consciousness. The medical term is “syncope,” which comes from the Greek “synkope,” meaning “contraction” or “cutting off.” It’s an apt expression, because syncope occurs due to a sudden reduction in blood flow to the brain. Syncope is remarkably common: about one-third of people report having at least one episode of fainting during their lifetime. But while “fainting” is commonly used to describe otherwise healthy people passing out, it can be due to a number of conditions, ranging from the harmless to the life-threatening.

Some of the most common causes of fainting include:

    Vasovagal syncope. The name of the condition refers to increased activity of the vagal nerve which signals the heart to slow down and for blood vessels (“vaso-“) to open up. This combination of effects leads to a drop in blood pressure and too little blood flow to the brain. The sight of blood or emotional or physical stress are common triggers for this condition. Straining during a bowel movement or even vigorous coughing may also provoke vasovagal syncope. And so can a warm environment or a feeling of panic or claustrophobia.
    Abnormal heart rhythm. If the heart rate is markedly slow or fast, blood pressure may fall and fainting may follow. Among the many triggers for an abnormal heart rhythm are diseases of the heart itself, certain medications, or an overactive thyroid gland.
    Orthostatic hypotension. This term means a drop in blood pressure that develops when going from lying down or sitting to standing up. Dehydration, medications or drugs (including alcohol), and heavy blood loss are common underlying culprits. The condition also becomes more common with age.

There are many other causes of fainting, such as low blood sugar or seizures. But in many cases, no cause can be found.

Although about 75% of people who faint have nothing serious as the cause, it’s important to get checked out to make sure you’re in that 75%. And even when nothing serious is found, many people injure themselves if they fall when they lose consciousness. People who’ve fainted and who have occupations that involve transporting passengers or the operation of heavy machinery may be advised to restrict activities that could put themselves or others at risk if they faint again.

Pregnancy is another situation that may make fainting more likely. The blood vessels tend to dilate during pregnancy and blood pressure is normally on the low side. It doesn’t take much to lower the blood pressure enough to cause fainting.
When fainting is fashionable

In some circumstances, fainting at a specific cue — “swooning” or “falling out” — became a cultural expectation. For example, it was common for aristocratic women in Victorian England to faint during a particularly dramatic moment. Examples abound of “hysterical fainting,” where large numbers of people near one another begin to faint due to an assumption of shared disease or exposure to a toxin, or even a curse. And then there’s the game we used to play in the neighborhood to intentionally faint: we’d breathe deeply and quickly for a while and then hold our breath and bear down. It never worked for me — that’s fortunate, since it can be dangerous.
The bottom line

The circumstances of Poppy Harlow’s fainting episode – a warm environment under the studio lights, pregnancy and a stressful job – would seem more than enough to trigger an episode of fainting. But she did the right thing in getting checked out by her doctor. In fact, perhaps the only surprising thing about fainting – including Poppy Harlow’s recent on-air event – is that it doesn’t occur more often.  The public health burden of hepatitis C is enormous. This serious viral infection of the liver causes cirrhosis, liver cancer, and end-stage liver failure, often requiring liver transplantation. Over 3 million people in the United States, and 150 million worldwide, are infected with hepatitis C virus, resulting in 700,000 deaths per year.

People who are infected with hepatitis C virus often have no symptoms. The virus persists in the liver, slowly damaging liver tissue over a long period of time. For this reason, it is critical that progression of liver damage be stopped before advanced liver disease or liver cancer occurs.

But there’s some very good news: in the last few years, we have witnessed extraordinary progress in developing new drug treatments for hepatitis C.  Sofosbuvir (Sovaldi) and sofosbuvir combined with ledipasvir (Harvoni) are two well-known examples of these new drug therapies. Another new combination drug, sofosbuvir and velpatasvir, which was recently described in a report in The New England Journal of Medicine, is extremely effective against most forms of hepatitis C virus and will become the standard therapy when this combination is approved by the FDA.

But even though the new drugs can cure hepatitis C in many cases, they are not accessible to all people who need them. The new hepatitis C drugs cost between $80,000 and $150,000 per year. People with excellent insurance coverage may see low out-of-pocket costs for these drugs. But because of the expense, many insurance companies have implemented cost-shifting schemes that require high co-payments from people with less robust plans, which puts these drugs beyond reach for many people.

In the United States, hepatitis C drugs are but one example of “specialty drugs.” These are newer drugs for many chronic conditions — such as cancer and arthritis — that have been priced at levels that are unaffordable for many people who need them.

Until drugs for hepatitis C, and other specialty drugs, are priced at affordable levels, some people without sufficient financial means will be left out and unable to benefit from modern advances in drug therapy. As a society, we must find ways to make these drugs accessible to all who need them while also compensating the drug companies for their high research and development costs. This is a difficult balance, but in a society based on fairness and equity, it is one we must achieve. Because no one with hepatitis C should go without treatment.

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