In This Issue
A Hepatitis Drug Shows Promise 1
United Way Campaign 2010 3
Making Friends with Fatigue 3
Poor Infection Control at Many Surgery Centers 5
Many Outraged as Accused Murderer Gets Liver Transplant 6
A Hepatitis Drug Shows Promise
By Andrew Pollack
New York Times – August 4, 2010 – A new drug for hepatitis C succeeded in late-stage clinical trials and could be on its way to market, the drugs' developers announced Wednesday morning.
Merck said that its antiviral drug boceprevir, when added to existing therapy, effectively cured about two-thirds of patients with hepatitis C. That was far better than the cure rate with the existing therapy alone.
Merck is in a heated race with Vertex Pharmaceuticals to bring to market the first of a new class of hepatitis C drugs that are expected to make treatment far more effective and also possibly shorter in duration. The existing treatment — with alpha interferon and ribavirin — can take nearly a year, causes severe side effects and succeeds in eradicating the hepatitis C virus only about half the time.
"This is a compelling profile for boceprevir,'' Peter S. Kim, president of Merck Research Laboratories, said on a conference call with analysts Wednesday. He said the company would complete its application to the F.D.A. for regulatory approval by the end of this year.
The early read by Wall Street was that Vertex's drug would not be blown out of the water by boceprevir. Shares of Merck, a huge company, barely budged. Those of Vertex, whose future is heavily dependent on the success of its hepatitis C drug, were up about 5 percent.
Merck, which obtained boceprevir when it acquired Schering-Plough, announced the results of two clinical trials, which were somewhat complicated in their structure.
In a trial involving 1,097 patients who were undergoing treatment for the first time, 66 percent of those who got boceprevir plus standard therapy for 48 weeks had a so-called sustained virologic response, compared to 38 percent of those getting the standard therapy plus a placebo.
In Vertex's phase 3 trial, the corresponding rates for its drug, telaprevir, were 75 percent and 44 percent.
A sustained virologic response means there was no detectable hepatitis C virus in the patient's blood 24 weeks after the treatment ended. Many doctors say that is essentially a cure.
Merck's other trial involved about 400 patients for whom prior treatment had been unsuccessful. For those who got boceprevir in a 48-week treatment regimen, 66 percent had a sustained virologic response, triple the 21 percent for those in the control arm.
Vertex has not yet reported phase 3 results for patients who have failed prior therapy.
Both Merck trials also looked at schemes in which treatment with boceprevir could be stopped at either 28 weeks or 36 weeks if patients had no detectable virus in their blood. The cure rates for those patients were nearly as good as for the full 48-week regimen. Merck did not say, however, how many patients were able to shorten the duration of treatment.
Merck said 15 percent of the patients in the trial testing initial therapy were blacks, a group that has a higher rate of hepatitis C than the rest of the nation's population and that also does less well on the existing therapy.
In the trial, 53 percent of blacks getting the 48-week treatment with boceprevir had a sustained virologic response, compared with 23 percent for those in the control group.
The crucial safety issue for boceprevir appears to be anemia. That is already a side effect for ribarvirin, one of the two drugs now used to treat hepatitis. But the boceprevir seems to make it worse.
Merck executives said that anemia could be controlled using drugs like Procrit or Aranesp.
Both boceprevir and telaprevir inhibit the protease enzyme made by the virus. Both are taken orally three times a day. The patients in both Merck's and Vertex's trials had a strain of hepatitis C called genotype 1, which is the most common strain in the United States and Western Europe and is particularly hard to treat.
Making Friends with Fatigue
Lucinda K. Porter, RN
Many of those who live with chronic hepatitis C virus infection (HCV) are all too familiar with one of its major side effects—fatigue. In fact, fatigue is the most common HCV complaint. I refer to it as the other F word, although I have been known to use the two F words together. What is this thing we call fatigue and what can we do about it?
In this article, I am going to tell you some of what you already know. Fatigue sucks. It can feel like you are pushing your body through sludge while wearing waders and a fifty pound pack. It's relentless and it casts a shadow on everything. Well-meaning people would tell me that if I exercised, I'd have more energy. It may be true, but how was I going to exercise if I was too tired? That's like telling a double amputee that you could walk if you got up out of the chair.
There are thousands of causes of fatigue. Some common ones are: diseases, jet lag, inadequate sleep, anemia, alcohol, supplements, drugs (prescription and non-prescription), inactivity, pregnancy, boredom, excess iron, stress, too much exertion, dehydration, depression, poor nutrition, pain, thyroid abnormalities, low testosterone or other hormone issues, diabetes and, of course, HCV.
Since there are so many causes of fatigue, the dilemma is figuring out if we are experiencing HCV-related fatigue, or if there is another cause. After years of debilitating fatigue, I asked myself that very question. It took a year of detective work, but I was able to figure out that my fatigue was not solely HCV-related. Now I am like the Energizer Bunny. Perhaps Energizer Turtle is a better comparison. I am slow, but I make it to the finish line with energy to spare.
If you figure out the contributors to fatigue, you may be able to fix or reduce it. Examine the common causes of fatigue mentioned in paragraph 3, and ask yourself if they could be contributing to your symptoms. Your medical provider is an essential part of the process, and will want to rule out the notorious energy-busters, such as anemia, thyroid abnormalities, sleep problems, diabetes, depression, dehydration and allergies. A thorough and honest look at alcohol, substance use, and excessive caffeine is essential. Your medical provider will also want to look at all medications, supplements and herbs that you take.
Determining the cause of fatigue is more a process of elimination than anything else. There are some clear connections between liver disease and chronic fatigue. Anemia may accompany liver disease. Some of the medications used to treat hepatitis cause fatigue. The liver may have an iron storage problem, which can cause tiredness. Fatty liver or autoimmune diseases that lead to hepatitis may cause fatigue. Some patients with liver disease experience a disruption of sleep patterns known as sleep reversal, which causes daytime fatigue.
Fatigue and Liver Disease
Let's begin by discussing the type of fatigue that is associated with HCV. According to Mark G. Swain, MD of the University of Calgary, fatigue may be classified in two ways.
Peripheral fatigue is associated with muscle, whether overused, underused, or weak. Usually this type of fatigue is not caused by liver disease except in advanced cases, such as decompensated cirrhosis.
Central fatigue is rooted in the brain and central nervous system. This type of exhaustion may be caused by chemicals in the brain. It is quite complicated, but the theory is that various factors affect this chemical system, leaving us to feel energized or tired. For more information, read "Fatigue" by Alan Franciscus in the May 2007 HCV Advocate.
Since the liver is in the upper right-hand side of the abdomen, you may be wondering how the brain and the liver are connected. In short, our bodies are complex organisms. Just like an earthquake may lead to a tsunami, a liver problem may affect another part of the body. Our bodies are chemical plants, manufacturing and releasing hormones, neurotransmitters, and immune substances. Some of these may be related to HCV or a liver disease. Or, these reactions may be related to the neuropsychiatric features of living with a chronic disease.
Part of your fatigue assessment will be lifestyle questions. Do you exercise, and if so, what do you do, how often and for how long? What does your diet look like? Do you smoke? Is there a lot of stress in your life? Do you have any fun?
If you tell me that the only vegetables you eat are French fries and the only greens in your diet are lime jelly beans, there may be a problem. If the only exercise you get is pointing the remote, then there may be a big problem—a problem with a solution.
I don't judge people about their lifestyle. I used to smoke, drink, sit, and eat chips as if these activities were a national sport. Not only will I not judge you, I urge you to not chastise yourself. Being critical doesn't solve problems—it just makes us feel bad about ourselves. Feeling crappy about ourselves may lead us deeper into the activities that make us tired.
Be honest, but not harsh. Ask this: What could be changed, even if you have no idea of how to make this change? Don't censor or judge your answers. For instance, you may think some exercise would be helpful, but you have a broken leg. You can't find a solution without identifying the problem.
Since fatigue is a tough problem to overcome, it can be difficult to figure out where to start. I am going to share some strategies that helped to get me started. This is personal rather than scientific.
First, I stopped fighting fatigue. In fact, I learned to embrace it. I started to watch how I related to fatigue. I was treating it like a huge monster, fighting it every step of the way. This fight was using up valuable mental energy that I was already short on.
I changed my attitude. I read about a study of people with chronic fatigue. After interviewing them, it was noted that people often said to themselves and others, "I am tired." The study subjects were divided into two groups. One group was instructed not to do anything differently. The other group was instructed to substitute the phrase, "I am getting my energy back" every time they felt tired. The outcome was that the people who told themselves they were getting their energy back reported significantly reduced fatigue. I practiced this regularly.
I stopped blaming hepatitis C as the sole cause of how I felt and became open to the possibility that other factors may have been contributing to how I felt. This was pivotal because it opened the door to slowly making significant lifestyle changes, which lead to more energy.
What are these changes? I sleep better because I wear ear plugs to block out my husband's snoring. I exercise and mediate every day and eat a Mediterranean diet. I don't smoke any longer, or drink alcohol. Remember, I wasn't always like this. It was a slow process. If nothing else, drink a lot of water. Not only will you stay hydrated, you'll get some exercise running to the bathroom. However, watch the water intake before bedtime so you don't disrupt your sleep with bathroom visits.
After you have addressed all the possible factors that may cause fatigue, in the end it may still come down to hepatitis C. There is still much to be learned about this virus. Join a support group if you haven't already. There is no substitute for being in a group with others who know what it is like to have HCV. At the very least, its one place you can go where no one will be offended if you fall asleep while others are talking
Source: HCV Advocate June 2010 Newsletter
Poor Infection Control at Many Surgery Centers
Carla K. Johnson
CHICAGO – (AP) June 8, 2010 - A new federal study finds many same-day surgery centers — where patients get such things as foot operations and pain injections — have serious problems with infection control.
Failure to wash hands, wear gloves and clean blood glucose meters were among the reported breaches. Clinics reused devices meant for one person or dipped into single-dose medicine vials for multiple patients.
The findings, appearing in Wednesday's Journal of the American Medical Association, suggest lax infection practices may pervade the nation's more than 5,000 outpatient centers, experts said. "These are basic fundamentals of infection control, things like cleaning your hands, cleaning surfaces in patient care areas," said lead author Dr. Melissa Schaefer of the Centers for Disease Control and Prevention. "It's all surprising and somewhat disappointing."
The study was prompted by a hepatitis C outbreak in Las Vegas believed to be caused by unsafe injection practices at two now-closed clinics.
It's the first report from a push to more vigorously inspect U.S. outpatient centers, a growing segment of the health care system that annually performs more than 6 million procedures and collects $3 billion from Medicare. Procedures performed at such centers include exams of the esophagus, colonoscopies and plastic surgery.
In the study, state inspectors visited 68 centers in Maryland, North Carolina and Oklahoma. They used a new audit tool focusing on infection control. At each site, inspectors followed at least one patient through an entire stay. Inspections weren't announced ahead of time, but staff was notified once inspectors arrived.
The new study found 67 percent of the centers had at least one lapse in infection control and 57 percent were cited for deficiencies. The study didn't look at whether any of the lapses actually led to infections in patients.
"These people knew they were under observation, had the opportunity to be on their best behavior and yet these lapses were still identified, some of which potentially are very dangerous and have been warned against explicitly," said Dr. Philip Barie of Weill Cornell Medical College in New York. Barie was not involved in the study but wrote an accompanying editorial in the journal.
A few centers in the study hadn't been inspected in 12 years. State agencies have the main responsibility for making sure centers comply with federal standards, but states often fall behind.
In the Nevada outbreak, officials notified 63,000 patients that they might have been exposed to blood-borne diseases. Nine cases of hepatitis C were linked to the clinics; more than 100 other cases also may be related.
States now are required to use the new audit tool to inspect centers participating in Medicare. Of surveys using the tool so far, 61 percent of centers have been cited for an infection control deficiency.
The new findings will cause centers to "redouble our efforts to improve patient care," said Dr. David Shapiro of the Ambulatory Surgery Center Association, a trade group. "Any incident is one too many."
Many Outraged as Accused Murderer Gets Liver Transplant
Arthur Caplan, Ph.D. msnbc.com contributor
July 26, 2010 - Johnny Concepcion, a 42-year-old man accused of stabbing his wife to death, just received a liver transplant at New York-Presbyterian/Columbia University Medical Center in New York. Now many are wondering how an accused killer could jump to the top of a long list of those needing transplants.
Concepcion has reportedly confessed to friends and relatives that he killed his wife, Jordania Sarita. Earlier this month, police found the 36-year-old woman stabbed at least 15 times in the home she had shared with her husband and their three children for 18 years. The two had recently separated.
After the murder, Concepcion took off and became the object of a huge manhunt by the New York City police. Knowing the cops were closing in, he swallowed a container of rat poison. After someone saw him collapse in the street and called 911, he was taken by ambulance to the hospital where doctors determined his liver had failed.
They searched the donor lists, a liver donor showed up, and Concepcion, who was charged with weapons possession and murder, received a transplant. My hunch is public funds paid the bill. As soon as he was released from the hospital he was taken to jail and is due in court in the Bronx to face the murder charge on Aug. 11.
So, what was Concepcion doing on the top of the liver transplant waiting list — which on Monday numbered 16,003 — when others who have not killed anyone or destroyed their livers by swallowing rat poison are desperately seeking new organs? And what were the doctors thinking transplanting a guy who had tried to kill himself, who showed up with a posse of police and whose new liver is not likely to ever get used outside prison walls?
The current system for distributing organs makes no exceptions either for murderers or attempted suicides. If there is a matching organ then the person who is the most in need, which Concepcion most certainly was, has top priority for it.
Did the doctors have to list Concepcion? They did not. They could have said he is a lousy candidate since he tried to kill himself and he is likely headed for prison where living with a liver transplant is not going to be easy.
But doctors don't make ethical judgments about those they care for. They treat the cop who has been shot and the criminal whom the cop shot with equal care. Medicine is not the place to start deciding whose illness is deserving and whose is not. Doctors are not trained to sort out the saints from the sinners but rather to treat everyone in need — an ethic that Concepcion benefited from but one that I don't think should be changed.
So what to do? If we don't want confessed killers or convicted murderers to get transplants, then our legislators should do something about that. At the end of the day if you are furious that Johnny Concepcion is still alive to face trial you should blame politicians, not doctors.
Arthur Caplan is director of the Center for Bioethics at the University of Pennsylvania.