Staff Report
11:40 AM Thursday, April 7, 2011
DAYTON — U.S. Sen. Sherrod Brown (D-Ohio) and U.S. Rep. Mike Turner (R-Centerville) on Thursday called on Veterans Affairs Secretary Eric Shinseki to establish a task force dedicated to investigate issues surrounding misconduct at the Dayton VA Medical Center.
“We must determine how, for more than 18 years, the VA allowed patient care to erode to the point where hundreds of patients at Dayton had to be tested for Hepatitis B, Hepatitis C and HIV because they were exposed to blood borne pathogens as a result of their care,” the letter reads.
The task force, as proposed, would review all of VISN 10’s facilities, activities and services, which includes all VA facilities in Ohio and parts of Indiana and Kentucky.
“Those who enabled this to happen must be held accountable,” the letter reads. “We must also identify the source of this problem and ensure that a similar working environment has not taken root at any other VA medical facility.”
The Dayton VA Medical Center in recent months has been rocked by a scandal in its dental clinic. Between January 1992 and July 2010, VA officials said a dentist failed to change gloves and sterilize instruments between patients, potentially putting at least 535 patients at risk for hepatitis B, hepatitis C and HIV. So far, two patients have tested newly positive for hepatitis B.
Racing family raises hepatitis C awareness
Comedian and K-State graduate Susan Dale has made progress on reality TV show "Livin' 4 Racin' Time" since its pilot aired in Tulsa, Okla., last January.
The show centers on her family — whose members live in Manhattan — and their race car team, Scuderia Shadetree Racing. What makes the program unique, however, is the underlying tone of hepatitis C awareness
Racing family raises hepatitis C awareness
Comedian and K-State graduate Susan Dale has made progress on reality TV show "Livin' 4 Racin' Time" since its pilot aired in Tulsa, Okla., last January.
The show centers on her family — whose members live in Manhattan — and their race car team, Scuderia Shadetree Racing. What makes the program unique, however, is the underlying tone of hepatitis C awareness
Healthy You
UC Berkeley Wellness Letter, May 2011
Ginkgo
Ginkgo biloba is an ancient Chinese herbal medicine, now widely available in pill form, especially in many "brain booster" supplements. Ginkgo contains many chemicals--notably flavonoids and terpenoids, which together may improve blood flow, reduce blood clotting, and have anti-inflammatory, antioxidant, and neuro-protective effects.
Claims, purported benefits: Improves circulatory disorders; prevents or reduces memory problems and dementia; treats eye disease and tinnitus. Prescribed in France and Germany for years against vascular disease and "cerebral insufficiencies," which can mean anything from absentmindedness and confusion to dementia.
Evidence: Some studies have found limited benefits in people with mild to moderate Alzheimer's disease or other kinds of dementia. But most of the studies have been small, poorly designed, or otherwise flawed. And there’s no convincing evidence that ginkgo helps healthy older people with normal age-related memory problems. Ginkgo shows promise for treating circulatory disorders, such as intermittent claudication (pain in the legs due to obstructed blood flow). Other claims are unproven.
Bottom line: Many questions remain unanswered—how effective ginkgo is against one disorder or another, how long it should be used, what the proper dosage is. Commercially available ginkgo products may not contain the same preparations used in the studies—or much ginkgo at all; worse, some have been shown to be high in lead. There's no evidence that ginkgo is a "brain booster" for healthy people. And people with Alzheimer’s should not experiment with ginkgo without professional advice; drug treatments may be better. Because of its anti-clotting effects, ginkgo may increase the risk of bleeding, particularly if you take aspirin daily. Do not use ginkgo if you have a blood clotting disorder.
The Lowdown on “Low T”
Is there such a thing as male menopause? In women, menopause is characterized by a cessation of fertility and a sharp drop in certain hormone levels at midlife. In that sense, men don’t go through their own version of menopause. Instead, men generally experience a slow but steady decline in testosterone over the decades, mostly after age 50. If a man’s testosterone level drops substantially (and especially if this causes adverse effects), it’s often called andropause or late-onset hypogonadism—though there’s much controversy about how to define this and thus how common it is.
As with menopause, pharmaceutical companies and “anti-aging” clinics are eager to medicalize andropause and market remedies for it. Direct-to-consumer ads make it sound as if many, perhaps most, older men should be taking supplemental testosterone in order to regain youthful vigor and reverse any andropause-related symptoms. How much should men worry about “low T,” as the too-clever ad campaign for a prescription testosterone gel calls it?
Diagnosing a deficiency: seldom clear-cut
Testosterone is the male equivalent of estrogen—a hormone that controls many aspects of sexuality as well as secondary sexual characteristics, such as facial hair, musculature, and voice quality. No one knows exactly what role declining levels of testosterone (and other hormones) play in the aging process. Here are some points to keep in mind:
• Though researchers have come up with various sets of age-related ranges of “normal” testosterone, blood levels vary greatly from man to man, and even during the course of the day in the same man. Expert groups have different cutoff points, and no one knows what the optimal levels are.
• Estimates of how many older men have low levels for their age vary widely—from 5% to 35%—depending on how these are defined and which forms of testosterone (total, free, or bioavailable) in the blood are used.
• Low testosterone, however it’s defined, is not a problem unless it is accompanied by undesirable symptoms. That’s why some guidelines require the presence of such symptoms for a diagnosis of age-related hypogonadism (andropause) to be made. For example, last year a major study of more than 3,000 European men (age 40 to 79), in the New England Journal of Medicine (NEJM), found that just 3% of men in their sixties and 5% in their seventies had hypogonadism, defined as low testosterone plus three sexual symptoms: poor morning erections, low sexual desire, and erectile dysfunction.
• In some men, low testosterone leads to decreased sexual drive, erectile dysfunction, loss of muscle and bone, fatigue, and other problems. Thus, supplemental testosterone is sometimes prescribed for older men with these problems, though the evidence regarding its effectiveness is mixed. These problems can have a host of other causes, of course. In fact, as was seen in the NEJM study, most men who have sexual symptoms have “normal” levels of testosterone. Moreover, most men with low testosterone levels suffer few, if any, related problems.
• Low testosterone is also often associated with conditions such as diabetes, bone loss, obesity, and high blood pressure. But it’s not certain whether low testosterone is a cause or an effect of these conditions, or whether supplemental testosterone can ameliorate them. In men with osteoporosis who have markedly low testosterone levels, hormone therapy may be beneficial, but more research is needed.
• Testosterone therapy has been linked to an increased risk of prostate cancer and heart disease, along with liver damage, sleep apnea, breast growth, and prostate enlargement. As with the proposed benefits, however, the evidence concerning most of these risks is inadequate or inconsistent. There have not been any large long-term clinical trials on testosterone therapy, along the lines of the famous Women’s Health Initiative study on menopausal hormone therapy. That study upended many hopes and beliefs when it found that the hormones had few benefits and actually posed serious risks.
Who needs testosterone “replacement”?
Some genetic disorders and other conditions (such as HIV infection and liver disease), as well as certain medications, may result in a dramatic drop in testosterone in young as well as older men. Such men may benefit from prescription testosterone therapy, but only on expert medical advice. This is a serious decision, since the long-term risks are unknown.
Words to wise men: Though testosterone is essential for making males masculine, lower levels as you grow older do not mean you are less of a man. Older men in good health can remain fit and stay sexually active, and many can father children. Hormone levels are only one part of the equation. Don’t assume you need testosterone therapy if you feel your libido is dropping off. But if you’re concerned about that or have other symptoms that may be related to a reduced testosterone level, talk to your doctor.
Ask the Experts
Q: I had shingles a few years ago. What are the chances that it will recur? Should I get vaccinated against it?
A: Shingles may recur a little more often than previously thought. It used to be assumed that a first outbreak boosted the immune system’s ability to ward off another attack, and that recurrences happened primarily in people with compromised immune systems. But a recent study from the Mayo Clinic of 1,669 people with shingles (herpes zoster) found that about 6% of them experienced a recurrence during the next eight years. That’s similar to the rate that would be expected for first cases of shingles.
The study did find that immunocompromised people (those undergoing chemotherapy, for instance, or who have leukemia, lymphoma, or HIV) had a higher recurrence rate, about 15%. Women were more likely than men to have shingles initially as well as a recurrence. Advanced age did not make people more prone to a second outbreak, but people who had more severe cases were more likely to have a recurrence.
Because the study ended in 2007, none of the subjects had gotten the shingles vaccine, which was approved that year for people over 60 and reduces the risk by half. The new study suggests that people who have already had shingles may also benefit from the vaccine, though this has not been adequately studied. People with a weakened immune system should not get the vaccine, however.
Q: I’ve heard that tart cherry juice has all sorts of health benefits. But a cup has 125 calories, almost all from sugar. Is it worth drinking?
A: It’s okay in moderation, but don’t count on it to prevent or treat any medical condition.
Many health claims have been made about cherries, especially tart ones: that they can lower blood sugar, regulate sleep, restore energy, and relieve arthritis and gout, among other conditions. A few years ago the FDA warned some companies to stop making such unproven claims.
Cherries are rich in antioxidants, particularly anthocyanins—pigments that give red, blue, and purple fruits and vegetables their intense color. Lab studies show that these anthocyanins help block inflammation. Other lab studies have suggested that compounds in cherries may lower cholesterol and blood sugar, inhibit cancer cell growth, and protect brain cells. But what happens in animals and in test tubes may not happen in people. The few human studies have been small, usually used large amounts of cherries or juice (in some cases supplying 250 calories or more a day), and showed modest benefits (helping older people with insomnia sleep a little better, for instance). Even if the results are confirmed by larger studies, the calories can be a problem.
Keep in mind, too, that much of the research has been funded by the cherry industry. It may be good research, but such sources are not likely to publish negative findings. Moreover, many red/blue/purple foods—including blueberries, blackberries, raspberries, and pomegranates—are also rich in anthocyanins (and other antioxidants) and have similar potential benefits.
Read More From Ask The Experts
Study: Hospital errors could be 10 times as high as previously thought
April 8, 2011 by MassDevice staff
MASSDEVICE ON CALL — As many as a third of the people admitted to hospitals in the U.S. may fall victim to a medical error during their stay, according to a study based on data from a new hospital error tracking system.
That would make medical errors 10 times more common than previously thought, according to a report in Health Affairs.
"It's a little scary," author Dr. David Classen of the University of Utah told WebMD. "We have gotten better tools to detect medical errors which give us a better yardstick to determine if we are improving."
The increased number could be due to better reporting and tracking, rather than an increase in actual errors, but which is still to be determined...continue reading..
From Medscape Medical News
Ginkgo
Ginkgo biloba is an ancient Chinese herbal medicine, now widely available in pill form, especially in many "brain booster" supplements. Ginkgo contains many chemicals--notably flavonoids and terpenoids, which together may improve blood flow, reduce blood clotting, and have anti-inflammatory, antioxidant, and neuro-protective effects.
Claims, purported benefits: Improves circulatory disorders; prevents or reduces memory problems and dementia; treats eye disease and tinnitus. Prescribed in France and Germany for years against vascular disease and "cerebral insufficiencies," which can mean anything from absentmindedness and confusion to dementia.
Evidence: Some studies have found limited benefits in people with mild to moderate Alzheimer's disease or other kinds of dementia. But most of the studies have been small, poorly designed, or otherwise flawed. And there’s no convincing evidence that ginkgo helps healthy older people with normal age-related memory problems. Ginkgo shows promise for treating circulatory disorders, such as intermittent claudication (pain in the legs due to obstructed blood flow). Other claims are unproven.
Bottom line: Many questions remain unanswered—how effective ginkgo is against one disorder or another, how long it should be used, what the proper dosage is. Commercially available ginkgo products may not contain the same preparations used in the studies—or much ginkgo at all; worse, some have been shown to be high in lead. There's no evidence that ginkgo is a "brain booster" for healthy people. And people with Alzheimer’s should not experiment with ginkgo without professional advice; drug treatments may be better. Because of its anti-clotting effects, ginkgo may increase the risk of bleeding, particularly if you take aspirin daily. Do not use ginkgo if you have a blood clotting disorder.
The Lowdown on “Low T”
Is there such a thing as male menopause? In women, menopause is characterized by a cessation of fertility and a sharp drop in certain hormone levels at midlife. In that sense, men don’t go through their own version of menopause. Instead, men generally experience a slow but steady decline in testosterone over the decades, mostly after age 50. If a man’s testosterone level drops substantially (and especially if this causes adverse effects), it’s often called andropause or late-onset hypogonadism—though there’s much controversy about how to define this and thus how common it is.
As with menopause, pharmaceutical companies and “anti-aging” clinics are eager to medicalize andropause and market remedies for it. Direct-to-consumer ads make it sound as if many, perhaps most, older men should be taking supplemental testosterone in order to regain youthful vigor and reverse any andropause-related symptoms. How much should men worry about “low T,” as the too-clever ad campaign for a prescription testosterone gel calls it?
Diagnosing a deficiency: seldom clear-cut
Testosterone is the male equivalent of estrogen—a hormone that controls many aspects of sexuality as well as secondary sexual characteristics, such as facial hair, musculature, and voice quality. No one knows exactly what role declining levels of testosterone (and other hormones) play in the aging process. Here are some points to keep in mind:
• Though researchers have come up with various sets of age-related ranges of “normal” testosterone, blood levels vary greatly from man to man, and even during the course of the day in the same man. Expert groups have different cutoff points, and no one knows what the optimal levels are.
• Estimates of how many older men have low levels for their age vary widely—from 5% to 35%—depending on how these are defined and which forms of testosterone (total, free, or bioavailable) in the blood are used.
• Low testosterone, however it’s defined, is not a problem unless it is accompanied by undesirable symptoms. That’s why some guidelines require the presence of such symptoms for a diagnosis of age-related hypogonadism (andropause) to be made. For example, last year a major study of more than 3,000 European men (age 40 to 79), in the New England Journal of Medicine (NEJM), found that just 3% of men in their sixties and 5% in their seventies had hypogonadism, defined as low testosterone plus three sexual symptoms: poor morning erections, low sexual desire, and erectile dysfunction.
• In some men, low testosterone leads to decreased sexual drive, erectile dysfunction, loss of muscle and bone, fatigue, and other problems. Thus, supplemental testosterone is sometimes prescribed for older men with these problems, though the evidence regarding its effectiveness is mixed. These problems can have a host of other causes, of course. In fact, as was seen in the NEJM study, most men who have sexual symptoms have “normal” levels of testosterone. Moreover, most men with low testosterone levels suffer few, if any, related problems.
• Low testosterone is also often associated with conditions such as diabetes, bone loss, obesity, and high blood pressure. But it’s not certain whether low testosterone is a cause or an effect of these conditions, or whether supplemental testosterone can ameliorate them. In men with osteoporosis who have markedly low testosterone levels, hormone therapy may be beneficial, but more research is needed.
• Testosterone therapy has been linked to an increased risk of prostate cancer and heart disease, along with liver damage, sleep apnea, breast growth, and prostate enlargement. As with the proposed benefits, however, the evidence concerning most of these risks is inadequate or inconsistent. There have not been any large long-term clinical trials on testosterone therapy, along the lines of the famous Women’s Health Initiative study on menopausal hormone therapy. That study upended many hopes and beliefs when it found that the hormones had few benefits and actually posed serious risks.
Who needs testosterone “replacement”?
Some genetic disorders and other conditions (such as HIV infection and liver disease), as well as certain medications, may result in a dramatic drop in testosterone in young as well as older men. Such men may benefit from prescription testosterone therapy, but only on expert medical advice. This is a serious decision, since the long-term risks are unknown.
Words to wise men: Though testosterone is essential for making males masculine, lower levels as you grow older do not mean you are less of a man. Older men in good health can remain fit and stay sexually active, and many can father children. Hormone levels are only one part of the equation. Don’t assume you need testosterone therapy if you feel your libido is dropping off. But if you’re concerned about that or have other symptoms that may be related to a reduced testosterone level, talk to your doctor.
Ask the Experts
Q: I had shingles a few years ago. What are the chances that it will recur? Should I get vaccinated against it?
A: Shingles may recur a little more often than previously thought. It used to be assumed that a first outbreak boosted the immune system’s ability to ward off another attack, and that recurrences happened primarily in people with compromised immune systems. But a recent study from the Mayo Clinic of 1,669 people with shingles (herpes zoster) found that about 6% of them experienced a recurrence during the next eight years. That’s similar to the rate that would be expected for first cases of shingles.
The study did find that immunocompromised people (those undergoing chemotherapy, for instance, or who have leukemia, lymphoma, or HIV) had a higher recurrence rate, about 15%. Women were more likely than men to have shingles initially as well as a recurrence. Advanced age did not make people more prone to a second outbreak, but people who had more severe cases were more likely to have a recurrence.
Because the study ended in 2007, none of the subjects had gotten the shingles vaccine, which was approved that year for people over 60 and reduces the risk by half. The new study suggests that people who have already had shingles may also benefit from the vaccine, though this has not been adequately studied. People with a weakened immune system should not get the vaccine, however.
Q: I’ve heard that tart cherry juice has all sorts of health benefits. But a cup has 125 calories, almost all from sugar. Is it worth drinking?
A: It’s okay in moderation, but don’t count on it to prevent or treat any medical condition.
Many health claims have been made about cherries, especially tart ones: that they can lower blood sugar, regulate sleep, restore energy, and relieve arthritis and gout, among other conditions. A few years ago the FDA warned some companies to stop making such unproven claims.
Cherries are rich in antioxidants, particularly anthocyanins—pigments that give red, blue, and purple fruits and vegetables their intense color. Lab studies show that these anthocyanins help block inflammation. Other lab studies have suggested that compounds in cherries may lower cholesterol and blood sugar, inhibit cancer cell growth, and protect brain cells. But what happens in animals and in test tubes may not happen in people. The few human studies have been small, usually used large amounts of cherries or juice (in some cases supplying 250 calories or more a day), and showed modest benefits (helping older people with insomnia sleep a little better, for instance). Even if the results are confirmed by larger studies, the calories can be a problem.
Keep in mind, too, that much of the research has been funded by the cherry industry. It may be good research, but such sources are not likely to publish negative findings. Moreover, many red/blue/purple foods—including blueberries, blackberries, raspberries, and pomegranates—are also rich in anthocyanins (and other antioxidants) and have similar potential benefits.
Read More From Ask The Experts
Study: Hospital errors could be 10 times as high as previously thought
April 8, 2011 by MassDevice staff
MASSDEVICE ON CALL — As many as a third of the people admitted to hospitals in the U.S. may fall victim to a medical error during their stay, according to a study based on data from a new hospital error tracking system.
That would make medical errors 10 times more common than previously thought, according to a report in Health Affairs.
"It's a little scary," author Dr. David Classen of the University of Utah told WebMD. "We have gotten better tools to detect medical errors which give us a better yardstick to determine if we are improving."
The increased number could be due to better reporting and tracking, rather than an increase in actual errors, but which is still to be determined...continue reading..
From Medscape Medical News
Zosia Chustecka
April 8, 2011 — "A considerable proportion of the most common and most lethal cancers is attributable to former and current alcohol consumption," concludes a large European study published online April 8 in BMJ.
The researchers attribute about 10% of all cancers in men and about 3% of all cancers in women to previous and current alcohol consumption.
The estimates come from an analysis of data from the huge ongoing European Prospective Investigation Into Cancer (EPIC) and from representative data on alcohol consumption compiled by the World Health Organization (WHO).
The risk increases even with drinking moderate amounts.
"This research supports existing evidence that alcohol causes cancer and that the risk increases even with drinking moderate amounts," coauthor Naomi Allen, DPhil, an epidemiologist at Oxford University, United Kingdom, said in a statement.
The original data in the EPIC study were collected from 1992 to 2000, so "the results from this study reflect the impact of people's drinking habits about 10 years ago," Dr. Allen noted.
"People are drinking even more now than they were then, and this could lead to more people developing cancer because of alcohol in the future," she added.
Data From 8 Countries
The EPIC study, which is still ongoing, is one of the largest studies of diet and cancer ever conducted. It involved more than half a million people in Europe.
For this analysis of alcohol and cancer, the researchers used EPIC data from 363,988 participants from 8 European countries — France, Italy, Spain, the Netherlands, United Kingdom, Greece, Germany, and Denmark. Two of these centers (France and the Netherlands) recruited only women, so the total cohort was about two thirds female (254,870 women; 109,118 men).
Data on the incidence of cancer was obtained through record linkage with national cancer centers and from sources such as death certificates, health insurance records, and pathology reports.
Information on alcohol consumption was collected using a detailed questionnaire about the frequency and amount of drinking and the type of beverages consumed during the previous year. The researchers also computed data on alcohol exposure in the general population using data from a WHO survey.
Cancer Attributable to Alcohol
The researchers assumed a causal association between alcohol and cancer of the upper aerodigestive tract (which includes the oral cavity, pharynx, larynx, and esophagus), liver cancer, female breast cancer, and colorectal cancer (as decreed by the WHO's International Agency for Research on Cancer).
The team then calculated the proportion of these specific cancers that could be attributable to previous and current alcohol consumption. They estimated that, in 2008, alcohol was responsible for 44% of the upper aerodigestive tract cancers in men and 25% in women, 33% of liver cancer in men and 18% in women, 17% of colorectal cancer in men and 4% in women, and 5% of breast cancer in women.
A substantial portion of these cancers attributable to alcohol consumption was linked to drinking more than the currently recommended upper limit, the researchers note.
The World Cancer Research Fund and the American Institute for Cancer Research recommend a maximum of 2 drinks per day (about 28 g of alcohol) for men and 1 drink (about 12 g) for women.
The team calculated that drinking more than this was responsible for 57% to 87% of the cancers attributable to alcohol (i.e., upper aerodigestive tract, liver, colorectal, and female breast cancer) in men and from 40% to 98% in women.
"Our data show that many cancer cases could have been avoided if alcohol consumption is limited to 2 alcoholic drinks per day in men and 1 alcoholic drink per day in women, which are the recommendations of many health organizations," said lead author Madlen Schütze, PhD student and epidemiologist at the German Institute of Human Nutrition in Potsdam-Rehbrücke, Nuthetal, Germany.
"Even more cancer cases could be prevented if people reduced their alcohol intake to below recommended guidelines or stopped drinking alcohol altogether," she said in a statement.
Although a substantial portion of the cancers were attributable to high alcohol intake, the remaining cancers were attributable to drinking alcohol at or under the currently recommended levels.
Risk Increases With Every Drink
"The cancer risk increases with every drink, so even moderate amounts of alcohol — such as a small drink each day — increases the risk of these cancers," according to a press release from Cancer Research UK, which cosponsors the ongoing EPIC study, along with several European agencies.
"Many people just don't know that drinking alcohol can increase their cancer risk," said Sara Hiom, director of health information at Cancer Research UK.
"Cutting back on alcohol is one of the most important ways of lowering your cancer risk," along with not smoking and maintaining a healthy bodyweight, she said.
The researchers touch on this point in their discussion. They refer back to studies that have shown a beneficial effect of alcohol on death from cardiovascular disease, especially coronary heart disease and ischemic stroke, which have in the past led to recommendations to enjoy a drink to benefit the heart.
But they point out that "even though light to moderate alcohol consumption might decrease the risk for cardiovascular disease, and mortality, the net effect is harmful."
"Thus, alcohol consumption should not be recommended to prevent cardiovascular disease or all-cause mortality," they write.
No Sensible Limit
The researchers also emphasize that this latest study, in addition to several others, shows that "there is no sensible limit below which the risk of cancer is decreased."
This point was also made recently in an editorial in the Journal of the National Cancer Institute (2009;101:282-283), which accompanied findings from the British Million Women Study showing that even 1 drink a day significantly increased the risk for cancer (J Natl Cancer Inst. 2009;101:296-305).
There is no level of alcohol than can be considered safe.
At that time, editorialists Michael Lauer, MD, and Paul Sorlie, PhD, from the division of prevention and population sciences at the National Heart, Lung and Blood Institute in Bethesda, Maryland, wrote: "From a standpoint of cancer risk, the message of this report could not be clearer. There is no level of alcohol that can be considered safe."
BMJ. Published online April 8, 2011. Full text
Pharmaceuticals
What Wall Street Is Saying About PSI-938 and PSI-7977
Drug makers have been laboring for years to develop new treatments for hepatitis C, an infectious disease which afflicts at least four times as many people worldwide as the virus that causes AIDS.
All that effort is paying off for patients and drug makers.
It's a big field that includes giants like Merck & Co. (ticker: MRK), Gilead Sciences (GILD), Bristol-Myers Squibb (BMY) and Johnson & Johnson (JNJ).
But the biggest winners so far: Up and coming biotech companies like Vertex Pharmaceuticals (VRTX) and Pharmasset (VRUS) whose future profits hinge almost entirely on cutting-edge hepatitis C medications.
"The science has changed drastically over the last decade so that we are now on the edge of a real revolution," says Phil Nadeau, an analyst at Cowen & Co.
Hepatitis C, which is also called HCV, is a blood-borne viral infection that attacks and damages the liver. It kills 10,000 Americans annually and is a leading reason for liver transplants in the U.S., according to the Centers for Disease Control and Prevention.
Existing drugs have many undesirable side effects and often don't work against the virus, which is spread through tainted blood, infected needles and occasionally unprotected sex.
But studies show new medications work faster and cure more patients. And in the next five years, the HCV market could more than triple in size to $10 billion, according to Thomas Russo, an analyst with Robert W. Baird & Co.
Today, Vertex is at the forefront in the fight against HCV. Its antiviral telaprevir could receive Food and Drug Administration approval next month, along with a similar drug from Merck called boceprevir (see Weekday Trader, "5 Breakthrough Drugs for 2011," Feb. 2, 2011). When added to existing treatments, the drugs nearly double the number of patients who achieve a sustained viral suppression — in effect, a cure.
But analysts see bigger sales from telaprevir – Leerink Swann's Howard Liang expects sales to total $2.2 billion in 2012 -- thanks to its shorter treatment duration.
By the fourth quarter of 2011, Vertex is expected to turn profitable, making it a far less speculative play for investors than Pharmasset, whose experimental compounds and profitability remain several years down the road.
"There will certainly be winners and losers in this market," says Cowen's Nadeau, advocating that investors use a so-called basket approach to picking stocks.
Right now, Roche Holdings (RHHBY) and Merck lead the $2 billion HCV market. Both companies make therapies that combine the antiviral ribavirin and weekly injections of a long-acting interferon to boost immune systems.
Taking a page from AIDS researchers, drug companies are now focused on oral medications that stop the virus from duplicating and spreading.
Currently 35 drugs are in development or awaiting FDA approval, says Cowen's Nadeau.
For now, Wall Street is focused on Vertex.
On April 28, an FDA advisory panel will vote on whether to recommend that the agency allow telaprevir on the market.
Leerink's Liang sees Vertex earning $3.68 a share in 2012.
Up 72% over the last two years, the stock trades at 12 times those earnings estimates.
Investors, however, have been showing far more enthusiasm for Pharmasset's stock, which has doubled in value since early March to roughly $99 a share.
That's when the company released results from a small trial that showed the drug maker's two-pill combination treatment – PSI-938 and PSI-7977 -- reduced the virus to undetectable levels in 94% of patients after two weeks.
It's early stage data. But it has made Pharmasset a central player in the next wave of HCV drug development – creating an all-oral treatment regime that excludes ribavirin and long-acting interferons.
"It is the Holy Grail and Pharmasset, so far, is the front runner in this race," says Leerink's Liang.
It could be 2014 before Pharmasset launches a drug or turns a profit, says Baird's Russo. The company is expected to lose $2.48 a share during the current fiscal year slated to end in September 2011. By 2017 Pharmasset's revenue could total up to $1.5 billion, says Russo.
Of course, getting a new drug approved by the FDA is no easy task. And these drug makers' stocks could sell off sharply after even the slightest setback.
Pharmasset's experimental drugs must still weather large-scale, late-stage studies.
Vertex's share price still faces a head-to-head battle with Merck's boceprevir.
And analysts worry that a few years from now even newer drugs could emerge as market leaders.
Nevertheless, lousy treatment options and the large number of new patients who could emerge in coming years offer investors in companies making hepatitis C drugs a compelling opportunity.
And in some cases, the risk is worth the reward.
Updated: Thu Apr. 07 2011 19:35:54
A 49-year-old woman faces charges in a pharmaceutical fraud case in Winnipeg.
The Manitoba Pharmaceutical Association (MPhA) said it began investigating a female staff member regarding missing money. As officials dug deeper, they discovered documents forged in exchange for payments between 2009 and 2010, said officials.
Ronald Guse, chair of the MPhA, wouldn't say which documents were false. Guse focused instead on easing concerns.
"We are wired for public protection and when that is challenged, we want to make sure our response is quick," said Guse.
The suspect was an employee of the Manitoba Pharmaceutical Association who was let go when the allegations came to light. Two pharmacists also had their licenses revoked as a result of an investigation.
The two pharmacists who had their licenses revoked had been practicing in Manitoba without proper licensing – one had been practicing for a few days, while the other had been doing so for almost a month, said officials.
"The risk to the public was minimal," said Guse.
Five pharmacists were flagged and in the end two had their licenses and registration revoked.
The two pharmacists who had their licenses revoked are Michael Narous and Rafat Kirolos. Police said they are looking to speak with them.
A four-month-long investigation by police led to charges being laid against the 49-year-old female suspect. She has been released on a promise to appear in court.
The MPhA took four months to report the crime to police. Officials admit to hiring a private public relations firm before or just after calling officers. The MPhA said the deputy minister of health was notified. Five more months passed, however, before the issue was made public.
The deputy minister of health said the province trusted the MPhA to deal with the matter.
Tim Saunders is a pharmacist who said he hopes the profession isn't left in a negative light.
"I know what I (had) to go through to become licensed so it should be pretty hard to get past those things to get approved," said Saunders.
- with a report from CTV's Stacey Ashley
Friday, April 08, 2011
By MICHAELANGELO CONTE
JOURNAL STAFF WRITER
A Union City man pleaded guilty yesterday to participating in a scheme to traffic in stolen pharmaceutical drugs worth $8.8 million and attempting to sell the drugs, which were taken in Georgia, for $1 million in North Bergen, officials said.
Luis Andres Faife-Ruiz, 44, pleaded guilty yesterday to conspiracy to receive and sell stolen goods, and one count of the receipt and attempted sale of the stolen goods, U.S. Attorney Paul J. Fishman announced.
The truck containing Xyzal, Nasacort AQ, Benzaclin Gel and Lovenox was stolen from a truck stop in Georgia on July 9, 2009 and it was driven to Florida, the indictment says.
In October 2009, a buyer offered $1 million for the drugs and the load was driven to a rest area on the New Jersey Turnpike where the co-conspirators met before the load was driven to a location in North Bergen to be inspected by the buyer, the indictment says.
The FBI seized the stolen drugs before the sale was complete, according to statements made in court.
Faife-Ruiz faces a fine of up to $250,000 on each count, as well as a possible sentence of up to five years on one, and up to 10 years on the second. He will be sentenced on July 12.
FDA
NEW YORK (CNNMoney) -- A government shutdown will severely restrict food and drug inspections, an official with the Food and Drug Administration warned Thursday.
"We will be pretty severely limited. We're hopeful that a resolution is reached before it comes to that," the official said.
Friday, April 08, 2011 :: Staff infoZine
Sprays, Gels and Liquids, Risk of Methemoglobinemia
Washington, D.C. - infoZine - FDA notified healthcare professionals and patients that FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products both as a spray, used during medical procedures to numb the mucous membranes of the mouth and throat, and benzocaine gels and liquids sold over-the-counter and used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.
Methemoglobinemia is a rare, but serious condition in which the amount of oxygen carried through the blood stream is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience signs and symptoms such as pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, and cases occurred mainly in children aged two years or younger who were reated with benzocaine gel for teething. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use. The development of methemoglobinemia after treatment with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was reported following the administration of a single benzocaine spray.
Recommendations
Benzocaine products should not be used on children less than two years of age, except under the advice and supervision of a healthcare professional.
Adult consumers who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations in the product label. Consumers should store benzocaine products out of reach of children. FDA encourages consumers to talk to their healthcare professional about using benzocaine.
Read the two Drug Safety Communications below for other specific recommendations for Healthcare Professionals, for Consumers and Caregivers and the Data Summary which supports these recommendations.
FDA is continuing to evaluate the safety of benzocaine products and the Agency will update the public when it has additional information. FDA will take appropriate regulatory actions as warranted.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
List Of U.S. Products that contain Benzocaine:
Americaine® Hemorrhoidal [OTC]
Anbesol® Baby [OTC]
Anbesol® Cold Sore Therapy [OTC]
Anbesol® Jr. [OTC]
Anbesol® Maximum Strength [OTC]
Anbesol® [OTC]
Benzodent® [OTC]
Bi-Zets [OTC]
Boil-Ease® Pain Relieving [OTC]
Cepacol® Fizzlers™ [OTC]
Cepacol® Sore Throat Pain Relief [OTC]
Cepacol® Sore Throat Plus Coating Relief [OTC]
Chiggerex® Plus [OTC]
ChiggerTox® [OTC]
Cylex® [OTC] [DSC]
Dent's Extra Strength Toothache Gum [OTC]
Dentapaine [OTC]
Dermoplast® Antibacterial [OTC]
Dermoplast® Pain Relieving [OTC]
Detane® [OTC]
Foille® [OTC]
HDA® Toothache [OTC]
Hurricaine® [OTC]
Ivy-Rid® [OTC]
Kank-A® Soft Brush [OTC]
Lanacane® Maximum Strength [OTC]
Lanacane® [OTC]
Little Teethers® [OTC]
Medicone® Hemorrhoidal [OTC]
Mycinettes® [OTC]
Orabase® with Benzocaine [OTC]
Orajel® Baby Daytime and Nighttime [OTC]
Orajel® Baby Teething Nighttime [OTC]
Orajel® Baby Teething [OTC]
Orajel® Cold Sore [OTC]
Orajel® Denture Plus [OTC]
Orajel® Maximum Strength [OTC]
Orajel® Medicated Mouth Sore [OTC]
Orajel® Medicated Toothache [OTC]
Orajel® Mouth Sore [OTC]
Orajel® Multi-Action Cold Sore [OTC]
Orajel® PM Maximum Strength [OTC]
Orajel® Ultra Mouth Sore [OTC]
Orajel® [OTC]
Outgro® [OTC]
Red Cross™ Canker Sore [OTC]
Rid-A-Pain Dental [OTC]
Sepasoothe® [OTC]
Skeeter Stik® [OTC]
Sore Throat Relief [OTC]
Sting-Kill® [OTC]
Tanac® [OTC]
Thorets [OTC]
Trocaine® [OTC]
Zilactin® Tooth & Gum Pain [OTC]
Zilactin®-B [OTC]
After conducting two 12-week clinical trials, the FDA has finally approved the usage of Horizant or gabapentin for getting relieve from the restless legs.
Yes, now the restless legs syndrome, in which the legs of sufferer start creeping and tugging sensations, and his legs move with an irresistible urge; can now be treated with the help of a seizure drug.
People who suffers restless legs syndrome generally get the devastating urge to move their legs, especially when they lie down. During the night, the condition worsens, making the sufferers sometimes pace for long hours for getting relieved from the discomfort.
However, the reason behind such twitchiness is still unknown in most of the cases, but in some it is the genetics that could be partly blamed. Besides, diseases like diabetes and kidney failure or condition when certain medication are applied, can also lead to such illness.
But according to very few health experts, such symptoms can be named as an actual disorder or can be stated as a syndrome worthy of treatment. It is not even widely spread.
At the same time, a case has been recently mentioned in a Neurologica blog according to which a patient suffering from such symptoms and condition is facing significant problems.
Just For Fun
By LISA SANDERS, M.D.
Published: April 8, 2011
For the past nine years, this column has presented medical mysteries that doctors eventually solve. Recently, we tried something different: posting a tough-to-diagnose case on well.blogs.nytimes.com and challenging readers to try to figure out what was wrong with the patient. More than 1,300 people responded with a lively combination of questions and answers. Now, you can try to crack the case and follow the crowd-sourced medical conversation.
Symptoms
A healthy 10-year-old girl told her mother that she was losing a lot of hair when she showered. Her mother didn’t give it much thought, until one morning when she saw for herself how much hair remained on her hands after making a ponytail for her daughter. Looking at her child’s head in the sunlight later that morning, the mother thought that maybe her hair was thinning. She took her to see Dr. Kathryn Italia, their pediatrician in Exton, a suburb of Philadelphia, that afternoon... Continue Reading........
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From Podium to Practice: Clinical Impact of New Data From EASL 2011
Previous Treatment Response Categorization Better Predictor of SVR Following Telaprevir-Based Therapy Than Response to 4-Week PegIFN/RBV Lead-in Phase
REALIZE Subanalysis: IL28B Genotype Not Significantly Associated With SVR in Treatment-Experienced Patients Receiving Telaprevir-Based Triple Therapy for HCV Infection
Telaprevir-Resistant HCV Variants Present at Time of Treatment Failure Replaced by Wild-Type Virus Over Time in Majority of Patients
Boceprevir Plus PegIFN/RBV Safe and Effective in Genotype 1 HCV–Infected Patients With Advanced Fibrosis/Cirrhosis
IL28B Genotype Predicts Lead-in Response, Likelihood of Shortened Therapy in SPRINT-2 and RESPOND-2 Phase III Boceprevir Trials
Among 1 Genotype HCV–Infected Patients Not Achieving SVR With Boceprevir-Based Regimen, Resistance-Associated Variants More Common in Those With Poor Response to 4-Week PegIFN/RBV Lead-in
Addition of Alisporivir to PegIFN/RBV Yields Superior Efficacy vs PegIFN/RBV Alone in Treatment-Naive Patients With Genotype 1 HCV
SILEN-C1: High Rate of Rapid and Sustained Virologic Response With Addition of BI 201335 to Standard of Care for First-line Treatment of Genotype 1 HCV Infection
Ritonavir-Boosted Danoprevir Plus PegIFN/RBV Produces Potent Antiviral Activity in Null Responders Infected With Genotype 1b HCV but High Rate of Viral Breakthrough With Genotype 1a
ASPIRE Interim Data: TMC435 Plus PegIFN/RBV Demonstrates High Rates of Response Through Week 24 in Patients With Genotype 1 HCV Who Failed Previous PegIFN/RBV
First SVR Data With the Nucleoside Analogue Polymerase Inhibitor Mericitabine (RG7128) Combined With Peginterferon/Ribavirin in Treatment-Naive HCV G1/4 Patients: Interim Analysis From the JUMP-C Trial (coming soon)
In Previous Null Responders With Genotype 1 HCV Infection, BMS-790052 Plus BMS-650032 Produces SVR in 36% Receiving Dual Therapy, 100% Receiving Concomitant PegIFN/RBV
ZENITH Interim Results: Potent Antiviral Activity With 12 Weeks of VX-222 + Telaprevir + PegIFN/RBV Quad Therapy, but Virologic Breakthrough Common With VX-222 + Telaprevir Dual Therapy
PSI-938 and PSI-7977 Purine and Pyrimidine Nucleotide Analogues Demonstrate Favorable Safety/Tolerability and Robust 14-Day Antiviral Activity Alone and in Combination Against Genotype 1 HCV
Pegylated Interferon-Lambda (PegIFN-λ) Shows Superior Viral Response With Improved Safety and Tolerability vs PegIFN α-2a in HCV Patients (G1/2/3/4): Emerge Phase IIb Through Week 12 (coming soon)
IL28B Genotype May Predict Response to PegIFN Treatment in Patients Chronically Infected With HBeAg-Positive Hepatitis B
Biochemical and Histopathologic Outcomes Not Improved With Addition of Metformin or Losartan to Rosiglitazone vs Rosiglitazone Alone in Patients With NASH
SOCRATES: Combining Sorafenib and TACE for Treatment of Advanced Hepatocellular Carcinoma Yields Promising Efficacy Results
New At NATAP
In Memory
By WILLIAM GRIMES
In the early 1950s, Dr. Prusoff also synthesized idoxuridine, a successful treatment for infant keratitis.
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