New On The Blog
The Risk - Contracting Hepatitis C In A Nonhospital Setting
Telaprevir Effective in Hard-to-Treat Cirrhotic HCV
HCV Infection May Predict Coronary Artery Disease
New @ Spoonful Of Medicine
A broad look at medical research news. Brought to you by Nature Medicine.
New HCV drugs trigger race for more tolerable therapies
By Sarah C P Williams
The approval this year of the first direct-acting antiviral drugs for the hepatitis C virus has ushered in a new era of treatment. Since the mid-May launch of Incivek (telaprevir) and Victrelis (boceprevir) — both of which disrupt viral replication by inhibiting HCV's protease protein — physicians have rapidly been prescribing the pills to many of the estimated 180 million people worldwide who are infected with HCV. This is reflected in October earnings reports showing that sales of Incivek reached nearly $420 million in the third quarter of this year alone, which puts it on pace to become the fastest blockbuster in the history of the pharmaceutical industry.
But Incivek, from Vertex Pharmaceuticals of Cambridge, Massachusetts, and Victrelis, from Merck of Whitehouse Station, New Jersey, currently have a catch. Each medicine must be taken with a broad-acting antiviral pill called ribavirin as well as with regular injections of pegylated interferon. Historically, viral clearance occurs in around half of all people who take interferon together with ribavirin, but another 20% can be cured of their HCV when doctors throw one of the new polymerase inhibitors into the mix. Interferon stimulates the immune system but comes with side effects ranging from flu-like fatigue to severe depression to cardiac arrhythmias. Up to a third of people on the protein ultimately stop the therapy early because of adverse reactions.
Against this backdrop, there was much fanfare over the 1 November announcement by the Princeton, New Jersey–based company Pharmasset that it would initiate the world's first phase 3 clinical study involving an all-oral, interferon-free protocol before the end of the year. The 500-person trial will compare a three-month regimen of the company's experimental polymerase inhibitor, PSI-7977, together with ribavirin against a six-month course of interferon plus ribavirin. PSI-7977 works by becoming incorporated into RNA chains being made by HCV, stopping the virus from replicating.
“There's been real concern that we might never be able to get away from interferon entirely, but now we're starting to get an inkling that that might not be the case,” says Gary Davis, director of the general and transplant hepatology unit at the Baylor University Medical Center in Dallas.
(Click here to continue reading.)
HCV Handout
Triple Therapy for HCV with Incivek, Pegasys and ribavirin is a major advance.
About 70% of previously untreated genotype one patients succeed with triple therapy. In addition, triple therapy permits the majority of patients to succeed with 24 instead of 48 weeks of treatment. 30-40% of nonresponders to Pegasys plus ribavirin are successful with triple therapy. Incivek is an inhibitor of HCV protease enzyme. The virus needs this enzyme to reproduce. Incivek reduces the viral level by 99.9% in less than one week. Incivek must be given with Pegasys and ribavirin or the virus quickly develops resistance.
Incivek is taken with fatty food such as cheese, peanut butter or meat every eight hours for the first 12 weeks of treatment. Pegasys is injected every week for at least 24 weeks. Ribavirin is taken with food twice daily every day for at least 24 weeks. Blood tests are checked before starting treatment, after 2 weeks and 4 weeks of treatment. Blood tests are then performed every 4 weeks while on treatment. Patients who test undetectable for HCV-RNA after 4 and 12 weeks of treatment have an excellent chance of cure of HCV with 24 weeks of triple therapy.
Incivek interacts with many other medications. Some medicines cannot be used at all and others must be dose adjusted.
Atorvastin (Brand name: Lipitor) cannot be combined with Incivek. Simvastin (Brand name: Zocor) cannot be used with Incivek. Lovastatin (Brand name: Mevacor) cannot be used either. All statin drugs are likely to be dangerous when combined with Incivek.
Ergot derivatives such as dihydroergoamine, ergonovine, ergotamine and methylergonovine cannot be taken with Incivek.
Rifampin must be avoided as well as Pimozide (Brand name: Orap).
Incivek potentiates sildenafil (Brand name: Viagra or Revatio). It will increase the risk of side effects of similar medications such as Levitra or Cialis.
Sedatives like alprazolam (Brand name Xanax) are increased by Incivek causing respiratory depression and increased sedation.
Alfuzosin (Brand name: UroXatral) cannot be used with Incivek. Cisapride (Brand name: Propulsid) must not be used with Incivek.
St. John’s wort must be avoided if you are taking Incivek.
Incivek interacts with many other drugs including methadone, hormonal birth control products, BP medicines like amlodipine (Brand name: Novasc). There are extensive interactions with medications used for HIV.
Depo Provera, oral birth control pills and NuvaRing do not work correctly with Incivek and pregnancy can occur. Patients on Incivek must use barrier methods of birth control like condoms and copper IUDs.
It is essential to take all of the medications on time, especially the telaprevir and Pegasys. If doses are skipped the treatment will fail. Set your alarm for 7AM, 3PM and 11PM and carry the alarm with you so you do not forget to take your medicine. If you skip doses your chance of success will fall significantly.
Flu like symptoms are common with Pegasys. Fever, chills, and body aches start four hours after the injection and last for 24-48 hours. Irritability, insomnia, loss of appetite and depression may occur. Bacterial infections are harder to treat in patients taking Pegasys. If you are coughing up yellow or green material or have other signs of infection you must start antibiotics immediately. Autoimmune diseases such as thyroid disease can be triggered or worsened by Pegasys.
Ribavirin causes birth defects. Females must avoid pregnancy during treatment and for 6 months after completion of treatment. Males must avoid getting a woman pregnant during treatment and for 6 months after completion of treatment.
Incivek causes anemia and rash in some patients. The rash can usually be treated with antihistamines like Benadryl, Claritin or Atarax. Creams like 1% hydrocortisone cream may help and some patients will have to stop Incivek if the rash is severe.
Patients who permanently eradicate their HCV with triple therapy will reduce their risk of liver failure, liver cancer and premature death from liver disease.
Source
Medication Guides;
Telaprevir/Incivek Prescribing Information
Medication Guide
VICTRELIS™- Boceprevir: Prescribing Information and Medication Guide
December 6, 2011 (San Francisco, California) — The recently approved and highly effective hepatitis C virus (HCV) protease inhibitor telaprevir was shown not to be cost effective for the treatment of patients with HCV genotype 1 and the (CC) interleukin (IL)-28B polymorphism, a genetic variant that predicts a favorable response to treatment with the standard dual regimen of pegylated interferon (peginterferon) and ribavirin.
This cost analysis was reported here at The Liver Meeting 2011: American Association for the Study of Liver Diseases (AASLD) 62nd Annual Meeting.
"IL-28B is the strongest pretreatment predictor of sustained virologic response in genotype 1 patients," said study presenter Ziad Gellad, MD, MPH, from the Department of Medicine–Gastroenterology, Duke University Medical Center, Durham, North Carolina. "In genotype 1 patients with the favorable (CC) IL-28B polymorphism, dual therapy with peginterferon and ribavirin is effective in the majority of patients."
That said, telaprevir in combination with peginterferon plus ribavirin has demonstrated significantly increased sustained viral response rates, compared with peginterferon plus ribavirin alone in phase 3 studies of treatment-naive and treatment-experienced genotype 1 patients with HCV.
Dr. Gellad asked: Is the addition of telaprevir cost effective in the subpopulation of patients with IL-28B (CC)? The answer, he said, is no.
"One of the potential benefits of tailoring therapy is decreasing cost," Dr. Gellad said. The current wholesale cost of the 2-drug regimen is $18,336 at 24 weeks and $36,672 at 48 weeks; for the 3-drug regimen, the cost is $67,536 at 12 weeks and $85,872 at 36 weeks.
Because the addition of telaprevir more than doubles the cost of treatment, Dr. Gellad designed a cost-effectiveness model to determine whether the added expense is really worth it for a patient with the favorable genotype 1 (CC) IL-28B profile.
The model is based on a number of assumptions: that societal perspective is limited, that no patients would have a coinfection with other viruses that accelerate liver-related death or prevent treatment, "and importantly, that nonresponders or relapsers after dual therapy are retreated with a 48-week course of telaprevir."
The researchers developed a decision model that evaluated 3 treatment strategies:
- peginterferon plus ribavirin for 48 weeks, with a 12-week stopping rule for nonresponse; patients who did not respond or who relapsed would be treated with telaprevir
- a response-guided treatment approach with peginterferon plus ribavirin, in which those who achieved a rapid viral response (undetectable at week 4) would receive 24 weeks of dual therapy alone, and those with still-detectable viral loads at week 4 were treated for 48 weeks; nonresponsive or relapsed patients received telaprevir.
- 12 weeks of telaprevir in combination with 24 or 48 weeks of peginterferon plus ribavirin based on the extended rapid virologic response.
Treatment outcomes generated by the model were based on outcomes data derived from the IDEAL, REALIZE, and ADVANCE clinical trials.
A theoretical cohort of patients with 10,000 iterations was performed. The end point assumed 1 of 2 health states: sustained virologic response (cure) or fibrosis progression. Dr. Gellad's team assessed the cost of each. "As patients progressed through the model, they accumulated costs, which were expressed in [quality-adjusted life-years]," Dr. Gellad explained.
"The key point is that the efficacy of all 3 strategies is similar, but when you consider point estimates, telaprevir is dominated by the interferon/ribavirin strategies, and this preference is driven by the cost of therapy," Dr. Gellad told Medscape Medical News.
Costs generated by the model were $46,785 for peginterferon plus ribavirin given as response-guided therapy, $54,931 for peginterferon plus ribavirin (not response-guided), and $68,788 for telaprevir plus peginterferon plus ribavirin.
"We then investigated the impact of the cost of telaprevir on the probability of cost effectiveness, and assumed a weekly cost of $3321 [the current cost of the drug].... If the cost dropped below $1433, a triplet with telaprevir became the preferred strategy," he reported.
Dr. Gellad concluded that in treatment-naïve patients with HCV genotype 1 and the (CC) IL-28B polymorphism, initial therapy with a telaprevir-based regimen is unlikely to be cost effective under current cost and efficacy conditions.
Comparison Shopping
"What this group from Duke did is very important because, with resources dwindling, we need to figure out whether a particular treatment is more cost effective than another," said AASLD president T. Jake Liang, MD, tenured senior investigator and chief of the Liver Diseases Branch at the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland. "This is somewhat related to so-called personalized medicine because it uses a genetic marker to identify patients who will respond well to a certain treatment."
Major genetic studies conducted over the past several years have indicated that (CC) IL-28B is a genetic marker highly associated with treatment response to interferon-based therapy. "This is a great marker — probably the best genetic marker we have so far — to gauge how a person will respond to treatment," Dr. Liang said.
The analysis by Dr. Gellad's team "suggests that this could be a way to save some money for patients with the favorable IL-28B genotype," he noted. Certainly, there is excitement about the recent availability of direct-acting antivirals, such as telaprevir, which greatly enhance treatment response, "but then again, maybe not one size fits all. In the spirit of personalized medicine, this may be one way we can reduce costs and, at the same time, retain the same success rate treating patients with HCV."
Dr. Gellad reports consulting for Merck & Co and receiving grants or research support from Merck & Co and PENTAX Medical. Dr. Liang has disclosed no relevant financial relationships.
The Liver Meeting 2011: American Association for the Study of Liver Diseases (AASLD) 62nd Annual Meeting. Abstract 118. Presented November 7, 2011.
Neil Canavan is a freelancer for Medscape.
Biotron brings hope for Hepatitis C sufferers
WHAT do Pamela Anderson, Chopper Read, Jim Nabors and Natalie Cole have in common? The answer is a Hep C infection.
So all of them will be interested in the results of Biotron's latest clinical trial.
Performed in Thailand, the phase 2a trial of its drug BIT225 with conventional treatment showed that 87 per cent of those who used the drug had undetectable levels of the virus in their blood after three months.
That is a significant advance on conventional anti-viral treatment alone and holds out hopes that a new combination treatment could one day completely rid the body of a Hep C infection.
Chief executive Biotron CEO Dr Michelle Miller said the results were "extremely encouraging" and were particularly good for patients with the most common genotype 1 variation of the disease, which is the most difficult to treat.....
Kauai, HI USA
December 4, 2011 - December 8, 2011
The focus of HEP DART 2011 is to assemble clinicians, researchers and basic scientists together to advance our knowledge of the ongoing drug development processes in the treatment of hepatitis B and hepatitis C and other viruses affecting the liver, including co-infections with HIV. HEP DART 2011 will uniquely blend the areas of biology, chemistry, pharmacology and clinical research to provide the scientific community with an increased understanding of the current and future challenges in therapeutics for hepatitis infection
HepDART Coverage @ NATAP
Fatty Liver
With Nonalcoholic Fatty Liver Disease Livers Are In Overdrive
When our livers become loaded with fat, it isn't because they are slacking. A new study of human patients in the December Cell Metabolism shows that fatty livers actually burn more fat, not less. All that "hard work" may be at the root of the organ damage that comes with nonalcoholic fatty liver disease (NAFLD), a condition associated with insulin resistance that affects about one in three in the U.S. population.
The findings represent a paradigm shift in the connection between metabolism and fatty liver disease, as it was previously thought that fatty livers burned less fat.
"Our overwhelming goal is to try to understand what happens in those with fatty liver," says Jeffrey Browning of the University of Texas Southwestern Medical Center. "By understanding what leads to the onset and progression of the disease, we hope we can come up with therapies that actually work."
Most studies of people with insulin resistance have focused on the more accessible skeletal muscle. Those studies show that the mitochondria that power skeletal muscle cells work at a slower pace in the context of metabolic syndrome, including insulin resistance and fatty liver. Browning and his colleague Shawn Burgess weren't so sure that muscle could tell you much about what might be happening in other organs, including the liver.
"Unless skeletal muscle is working, it doesn't have much of an energy requirement," Browning explained. "The liver is always working." The liver breaks down fat and makes glucose and ketone bodies that fuel the rest of our bodies, including our hearts and our brains.
In the new study, the researchers used a special method that allowed them to trace metabolic inputs and outputs in the human liver in people with low and high levels of triglyceride fats in their livers. Those studies show that people with fatty livers are breaking down lipids 50 percent faster and producing glucose 30 percent faster in comparison to those with healthy livers.
That increased demand on the liver suggests a link between fatty liver, oxidative stress, and liver damage. Browning says that means therapies including antioxidants like vitamin E might help protect the liver.
The researchers now hope to explore how metabolism shifts over the course of the disease. One day the tracer technique they have developed might even help to identify those patients at the greatest risk of progressing to the point of liver transplantation.
"A third of the population has fatty liver, and it is difficult to look at them and tell anything without a liver biopsy," Browning says. The trouble is all those biopsies would simply overwhelm the health care system.
Perhaps most important, the findings show that researchers need to rethink what insulin resistance means for the functioning of mitochondria throughout the body. "Skeletal muscle is very different from the liver," he says.
Lipid-Modifying Enzyme: New Target For Pan-Viral Therapeutics
Three different disease-causing viruses -- poliovirus, coxsackievirus, and hepatitis C -- rely on their unwilling host for the membrane platforms enriched in a specific lipid, phosphatidylinositol 4 phosphate (PI4P) on which they can replicate, Rutgers University researchers said on Dec. 7, at the American Society for Cell Biology annual meeting in Denver.
The viruses carry proteins that enable them to gain access to the P14P lipid for replication. The proteins snare one of the host's own lipid-modifying enzymes, a Type III PI4-kinase (PI4-kinase), reported Nihal Altan-Bonnet, Ph.D., of Rutgers University....
Hepatitis B
The Increasing Burden of Imported Chronic Hepatitis B — United States, 1974–2008
Discussion Only
Click Here For Full Text
Our data suggest that over the past 35 years in the United States chronic HBV infection has become a disease affecting immigrants disproportionately. This trend is the result of a substantial decline in new HBV infections acquired in the United States in the past 20 years compared to a lack of decline in the number of imported cases, such that well over 90% of new cases of chronic hepatitis B in the United States are now attributable to importation. Certain populations of immigrants, such as those from the Western Pacific and Sub-Saharan African regions, are likely at the highest risk of HBV infection prior to immigration. The national strategy for elimination of domestic transmission of HBV through immunization must take into account the burden of disease among foreign-born Americans.
This U.S. hepatitis B immunization strategy, first recommended by the Advisory Committee on Immunization Practices (ACIP) in 1991, calls for routine vaccination of infants against HBV infection beginning at birth, catch-up vaccination for older children and adolescents who have not completed the series, screening of all pregnant women to reduce transmission to the newborn, and vaccination of at-risk adults, including international travelers to regions of high or intermediate prevalence [14]. Such measures have led to a substantial decline in new U.S.-acquired cases, but cannot prevent infections acquired prior to immigration.
However, early diagnosis of chronic HBV infection can benefit immigrants and their families. Since 2008, CDC has recommended serologic screening of persons born in countries with either high or intermediate HBsAg seroprevalence [4], but immigrants are likely inconsistently screened [15]–[16]. Recent studies have demonstrated the cost-effectiveness of screening migrant populations for chronic HBV infection, both in the U.S. and in other countries [17]–[18], due to the potential for intervention in the disease process at an earlier stage [19]–[20]. Household members of persons with chronic HBV infection should be offered screening, and if susceptible, vaccination.
Voluntary screening in the United States after immigration would involve significant education and outreach efforts, in order to ensure that a large proportion of at-risk immigrants are tested. All immigrant applicants to the United States undergo a federally required medical exam as part of the application process; however, its purpose is to identify inadmissible conditions, such as active tuberculosis. Chronic HBV infection is not a condition that would preclude immigration, and therefore is not screened for at that time. The required exam may still provide an opportunity for education of applicants from intermediate and high risk countries about the disease and the importance of testing after arrival in the United States.
Such education could occur in conjunction with vaccination. Immigrants are required to receive ACIP-recommended vaccines during the exam; therefore, immigrating children receive hepatitis B vaccine [20]. However, there is no ACIP recommendation for HBV screening prior to vaccination; this may impart a false sense of immunity among vaccinated, HBV- infected individuals and discourage families from seeking screening for their child after immigration. Further, although hepatitis B vaccine is ACIP-recommended for certain groups of at-risk adults, there is no specific recommendation for vaccination of adult immigrants from intermediate or high-endemicity countries. Vaccine stakeholders should consider the current application of hepatitis B vaccine guidelines in immigrating populations, and determine whether more specific recommendations for vaccination of immigrants and others from intermediate or high-risk countries are warranted, including discussion of whether hepatitis B screening should be recommended for such individuals prior to vaccination.
Global Hepatitis B (HB) vaccine programs are another critical disease control measure that will eventually reduce chronic hepatitis B importation into the United States, a country of immigrants [21]. HB vaccine is highly effective in preventing infection [22], and as of 2008, the primary 3-dose series for infants and children has been introduced in 180 (92%) countries worldwide [23]. However, vaccine coverage is not optimal in many of these countries. For example, only a third of the countries with a high prevalence of chronic HBV infection have implemented the birth dose of HB vaccine [23]. While global immunization programs are dramatically reducing HBV infection rates in younger age groups, there would be a slower decline in the rates of chronic hepatitis B among U.S. immigrants, whose median age is currently 30–34 years [10], emphasizing the importance of screening programs targeting immigrant groups.
Our data should be interpreted with some caution. The prevalence estimates used are assumed constant for 1974–2008, while in reality, country-specific prevalence data may be changing. In addition, the data used are from a variety of sources and, in the case of countries with limited epidemiologic data, represent expert consensus rather than actual serologic prevalence. Another limitation is that country prevalence estimates may not be fully representative of the U.S. immigrant population, since immigrants may be derived from certain ethnic groups or regions which may have different HBV prevalence rates than the national average, and we did not estimate the contribution from certain groups for whom reliable population data do not exist, such as students on temporary visas or undocumented immigrants, although the estimated change in imported cases due to the 1989–1993 spike in Pan-American immigrants from low HBsAg-prevalence countries when amnesty was granted to undocumented immigrants [24]—still substantially dwarfed by cases imported from the Western Pacific region (Figure 2)—may provide an estimate of the effect from such groups. Nonetheless, even a cautious interpretation of these estimates would suggest that there is a disproportionate burden of disease in new Americans. Future studies could determine the actual, rather than estimated, HBV seroprevalence among new immigrants to the United States and assess the implementation and impact of CDC screening recommendations in reducing related morbidity and mortality among immigrants.
In conclusion, chronic hepatitis B is an important global public health concern, which in the United States disproportionately and increasingly affects the immigrant population. Because global and national immunization programs would not assist many already-infected current immigrants, earlier identification of infection is needed to prompt the initiation of appropriate disease control measures. Early screening would enable earlier referral for monitoring and therapy in the United States, and promote patient awareness and education. Such measures could reduce morbidity and mortality, as well as transmission of a common but potentially fatal infection, among new Americans.
HIV
Hepatitis C doesn't affect cognitive function of women, but some evidence HIV does
Infection with hepatitis C does not affect the cognitive performance of women with or at risk of HIV, according to data from the Women’s Interagency HIV Study (WIHS) published in the online edition of the Journal of Acquired Immune Deficiency Syndromes.
“We were unable to show a significant association between the presence of HCV [hepatitis C virus]…and performance on our cognitive battery nor that there is an interaction between HIV and HCV in their effect on cognitive function,” write the authors.
However, their was some evidence that infection with HIV had an impact on cognition.
A number of earlier studies have suggested that hepatitis C-infected individuals have an increased risk of neurocognitive impairments. Moreover, replicating virus has been found in the brains of patients with the infection. It has also been suggested that co-infection with HIV and hepatitis C could have a worse impact on cognitive function than either virus alone.
Women have been unrepresented in research exploring the impact of hepatitis C on cognition. Therefore, investigators from the WIHS designed a study involving 1338. Just under a fifth (18%) had detectable hepatitis C virus and 67% were infected with HIV.
“To our knowledge this cohort for our study is over twice as large as any previously reported study of the effects of HCV and HIV on cognition,” note the investigators.
The patients were divided into six groups:
-
Negative for both HIV and hepatitis C RNA (392 individuals).
-
HIV-negative/hepatitis C RNA-positive (42 individuals).
-
HIV-positive/hepatitis C RNA-negative (480 individuals).
-
AIDS/hepatitis C RNA-negative (241 individuals).
-
AIDS/hepatitis C RNA-positive (88 individuals)
The patients had a battery of four tests to assess their cognitive function. The results were controlled for age, ethnicity, depression, liver disease status and current or past drug and alcohol abuse, all of which have been shown to affect cognitive function.
There were significant differences between the patients according to their hepatitis C and/or HIV-infection status.
Individuals infected with hepatitis C were a significant nine years older than women who did not have hepatitis C (p < 0.001). Rates of injecting drug use were also significantly higher among the women with hepatitis C (85% vs. 12%), and hepatitis C-infected women were also significantly more likely to report recent use of cocaine (p < 0.001).
As expected, liver function was significantly poorer in those infected with hepatitis C, and the women with an AIDS diagnosis had lower CD4 cell counts than other individuals (p = 0.001).
After controlling for potential confounders, the investigators failed to find any association between hepatitis C viraemia and cognitive performance.
In their first set of analysis, they established a significant connection between poorer liver function and poorer cognitive function (p less then 0.001). However, this relationship disappeared after controlling for factors such as age, ethnicity, depression and general mental health.
Nevertheless, infection with HIV was associated with impaired speed of information processing and perceptual motor ability (p less then 0.001).
The investigators do not regard their findings as definitive: “The question of whether HCV has a direct effect on cognition will require future studies with a complete neuropsychological batter, a large control group and a large group of HCV-mono-infected subjects.” They also believe that such studies would need “a cohort that includes both men and women.”
Crystal H et al. Effects of hepatitis C and HIV on cognition in women: data from the Women’s Interagency HIV Study. J Acquir Immune Defic Syndr, online edition, doi: 10.1097/QAI.0b013e318240566b, 2011 (click here for the free abstract).
Four-in-one HIV pill may be exception among combination drugs
Posted: 2011-12-07 10:50
By Hannah Waters
The 1960s cartoon The Jetsons envisioned a future where single pills provided the same nutrition, taste and satiation as food that required chewing. That time-saving tablet remains a pipe dream, but the drugmaker Gilead is trying to deliver a similarly inspired pill for HIV medicines. On 27 October, the California company submitted an application to the US Food and Drug Administration (FDA) for its four-in-one HIV pill, which, if approved, would contain more medicines than any pill currently on the US market. The so-called 'Quad' pill promises the same virus-controlling ability as the four drugs separately but should be easier to use for people with the infection.
The idea of combining multiple medicines is seen by some as an easy shortcut to reinvigorating old products. Drugmakers can often simply repackage what's already on the market, and, because the individual components have already been approved, the hassle of large clinical trials is off the table. The FDA generally requires only simple bioequivalence tests to ensure that drug dosing is consistent with the individual medicines, and, at most, a small human trial to prove similar efficacy.
(Click here to continue reading.)
Big Pharma
Pharmaceutical spam
Medical disinformation on the internet
Spam advertising of pharmaceutical products is leading patients to seek out information about prescription drugs online, according to a report to be published in the International Journal Business and Systems Research. If those drugs are not available to the internet user through their physician there is a risk that they may obtain such products via illicit means.
The direct advertising of pharmaceutical products to patients is outlawed in several countries, but spam marketing is all-pervasive and wholly ignores national and international laws. It exists because a sale to even a tiny percentage of the hundreds of millions of people targeted every single day with product offers nets the spammers a profit. Now, Sanjoy Ghose and Vikas Lachhwani of the University of Wisconsin-Milwaukee, have investigated how exposure to spam offering prescription pharmaceuticals motivates individuals to seek additional information on the internet.
Prescription drugs improve health and extend life for many millions of people and it is perhaps natural that patients will seek information about their medication from a variety of sources other than their medical practitioner despite the fact that it is only such a practitioner who can legally prescribe that medication. However, the relationship between patient and pharmaceutical company has changed significantly over the last few decades, and most recently with the advent of the commercial internet and the World Wide Web.
"Over the last few decades, there has been a marked change in the way firms view the patient–drug interface," the team reports. "Patients are now more like 'consumers' and prescription drugs 'consumer products. Marketers now communicate directly with consumers through advertisements where it is legal to do so." There has been much debate over DTCA, direct-to-consumer advertising, but little ongoing discussion of the effect of internet-based communication on consumers. Specifically, there have been very few empirical analyses on the determinants of information seeking over the internet for prescription drugs, the team asserts. They point out that most of the earlier research has focused on consumers' responses in terms of interaction with physicians, and requests for specific drugs after exposure to advertising.
The team's study reveals that exposure to prescription drug spam motivates patients to seek further information over the internet. The reason for this could be the skepticism associated with advertising in general and especially for the case of unregulated spam-based advertising. However, the finding is a double-edged sword as the information seeking might also be associated with attempting to procure prescription medication from sources other than a medical practitioner. The data they report should help move the debate in this area forward and allow policy makers to better determine the impact of medical marketing on patients.
"Online information seeking for prescription drugs" in Int. J. Business and Systems Research, 2011, 6, 1-17
Four years ago, the US began requiring researchers to register studies of prescription drugs and report results on ClinicalTrials.gov, the federal database. But a new study found that, while the mandate increased the number of trials that were registered, 39 percent were actually registered late and results for only 12 percent of completed trials were reported within one year, as required.
Another interesting finding: clinical trials that were funded by the pharmaceutical industry were more than three times as likely to report results than trials that were funded by the National Institutes of Health.......
"Our country's pharmaceutical companies are experiencing various problems such as the lack of an integrated credit system, inadequate supervision and a weak technical foundation. Medicinal safety is in a high-risk stage," according to a statement released on Wednesday after a State Council executive meeting presided over by Premier Wen Jiabao.
The 2011-2015 plan set the general goal of "sharply" increasing the safety level and people's satisfaction with drugs by ensuring that all pharmaceutical products meet the standards of a newly revised regulation on medical product quality management by the end of 2015, the statement said.
Healthy You
Tart Cherry Juice Drinkers Gain Sleep Advantage
New Research Suggests RED Hot Super Fruit May Be a Natural Sleep Aid
Newswise — LANSING, Mich., December 8, 2011 – Americans seeking a better night’s sleep may need to look no further than tart cherry juice, according to a new study in the European Journal of Nutrition. 1 An international team of researchers found that when adults had two daily glasses of tart cherry juice, they slept 39 minutes longer, on average, and had up to 6 percent increase in overall sleep efficiency (significantly less non-sleep time in bed), compared to when they drank a non-cherry, fruit cocktail.
In a study conducted at Northumbria University, twenty healthy adults drank two servings of tart cherry juice concentrate (30mL of 100% pure Montmorency juice concentrate per serving, diluted in a half pint of water; provided by CherryActive, Sunbury, UK) or a non-cherry fruit drink for seven consecutive days at a time – one serving when they woke up, and another before bed. The researchers tracked participant’s sleep habits, and after drinking the cherry juice, they found significant improvements in sleep behaviors, most notably longer sleep time, less daytime napping and increased overall sleep efficiency (the ratio of time spent in bed to time spent sleeping) compared to when they drank the non-cherry juice drink.
The researchers attribute the sleep benefits to the melatonin content of the red Super Fruit – a powerful antioxidant critical for sleep-wake cycle regulation. Each serving of the tart cherry juice concentrate was estimated to contain the equivalent of 90 – 100 tart cherries, providing a significant level of melatonin in the juice and ultimately in the bodies of the participants.
Previous research has supported the benefits of tart cherries as a sleep aid – a potentially wide-reaching benefit since nearly one-third of all Americans suffer from sleep disturbances affecting their health and wellbeing, according to the Centers for Disease Control and Prevention. 2,3 Currently, Americans spend more than $84 million on over-the-counter sleep aids each year, leaving many searching for cost-effective ways to help manage their conditions. 4 While more research is necessary before medical professionals turn to cherries as a sole treatment for sleep disorders, the scientists conclude that tart cherry juice concentrate could be a viable “adjunct intervention for disturbed sleep across a number of scenarios.”
Go RED Instead
Tart cherries in juice, dried and frozen form are packed with other powerful antioxidant compounds, including anthocyanins – the compounds responsible for cherries’ bright red color. In addition to a growing body of evidence supporting the benefits of tart cherry juice as a sleep aid, research indicates that tart cherries may help reduce inflammation related to arthritis, heart disease and exercise-related muscle pain.
To learn more about choosing cherries in your diet year-round and for easy-to-follow recipes, visit choosecherries.com.
The Cherry Marketing Institute (CMI) is an organization funded by North American tart cherry growers and processors. CMI’s mission is to increase the demand for tart cherries through promotion, market expansion, product development and research. For more information on the science supporting the unique health benefits of cherries and for cherry recipes and menu ideas, visit www.choosecherries.com.
Sources:
1. Howatson G, Bell PG, Tallent J, Middleton B, McHugh MP, Ellis J. Effect of tart cherry juice (Prunus cerasus) on melatonin levels and enhanced sleep quality. Eur J Nutr. 2011 Oct 30 [Epub ahead of print].
2. Pigeon WR, Carr M, Gorman C, Perlis ML. Effects of tart cherry juice beverage on the sleep of older adults with insomnia: a pilot study. Journal of Medicinal Food. 2010;13:579-583.
3. Centers for Disease Control and Prevention. “Unhealthy sleep-related behaviors – 12 states, 2009.” Morbidity and Mortality Weekly Report. March 4, 2011 / 60(08);233-238. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6008a2.htm
4. Hossain JL, Shapiro CM. The prevalence, cost implications, and management of sleep disorders: an overview. Sleep and Breathing. 2002;6:85-102.
Depressed? Crossed wires in the brain
Major depressive disorder (MDD) is a severely debilitating illness characterized by sadness and an inability to cope. Not only does it affect a person's ability to concentrate and make decisions, it also alters their ability to experience pleasurable emotion, and instead prolongs negative thoughts and feelings. New research published in BioMed Central's open access journal Biology of Mood & Anxiety Disorders used functional magnetic resonance imaging (fMRI) to show aberrant connectivity in depressed brains.
Researchers from Stanford University compared the fMRI scans of women who were resting (but still awake). Half of the women were diagnosed with depression at the time of the scan and the other group consisted of women who did not currently have, nor had ever had, severe depression.
fMRI measures changes in blood flow and by overlaying images of depressed and unaffected brains, a number of differences came to light. The images showed that the depressed had decreased connectivity between several key regions of the brain responsible for emotional behaviour, learning, memory and decision making.
Daniella Furman explained, "In addition to decreased connectivity between emotion processing regions of the brain, we found that depression was linked to an increase in connectivity between the dorsal caudate and an area of the prefrontal cortex. Deep within the brain, the caudate is thought to be involved in learning, motivation, and emotion while the prefrontal cortex at the front of the head is involved in maintaining goals and likely regulating emotional behaviour. Together, these regions may act to filter out irrelevant thoughts or actions."
She continued, "Greater connectivity between the dorsal caudate and prefrontal cortex might reflect the inability of the depressed to update their working memory and, as a result, sustains negative thoughts. In fact we found evidence for a parallel increase in tendency to ruminate on bad thoughts."
Media Contact
Guy Melzack
PR Manager, BioMed Central
Tel: 44-20-3192-2363
Mob: 44-7786-704-029
Email: guy.melzack@biomedcentral.com
For Your Reading Pleasure-Grand Rounds, Selena and PloS One
Grand Rounds is a weekly summary of the best health blog posts on the Internet. Each week a different blogger takes turns hosting Grand Rounds, and summarizing the best submissions for the week.
Hosted this week by blogborygmi
Grand Rounds has traditionally been motivated by traffic – hosts wanted their efforts rewarded with new visitors. Submitters wanted people to follow their links.
Now, however, I think the motivations are a little more muddled. Do people want followers? Likes? Retweets? Customers? Klout?
Well, what I want to do today is simply this: serve up some links to compelling healthcare writing from around the blogosphere.
That’s my vision, for this week at least. Next week, the carnival moves on, and you can check out the next interpretation of Grand Rounds at GlassHospital.com.
A few links:
The odds of having a history of each of the adverse cardiovascular events ranged from 2.21 to 4.18 times higher for patients receiving usual care at ERs compared to private doctors’ offices.
About 11% of participants who received their usual care in ERs had self-reported histories of diagnosed myocardial infarction, compared to 3% to 4% of participants at each of the other sites of care.
Sabehgi said he was vomiting and had diarrhea, and that the nurse on duty only offered him a suppository, which he refused to take. After 18 hours someone had the good sense to call for an ambulance to take Sabehgi to a hospital. He was taken into surgery for repair of a lacerated spleen…
This case proves that — used judiciously — the data stored in EHR systems can be more than just a paper-saving technology; they can save lives. It gives CIOs tasked with implementing EHRs and building data warehouses a human face to attach to all the seemingly soulless bits and bytes.
Great Book Review From Selena
Book Review:
Free from Hepatitis C
by Lucinda Porter, RN
Read The Complete Review Here
I finished reading her book over the weekend and I highly recommend it to people living with Hepatitis C and their caregivers. Ms. Porter's book reads like a warm and caring pep talk.
Individual happiness is a fundamental societal metric. Normally measured through self-report, happiness has often been indirectly characterized and overshadowed by more readily quantifiable economic indicators such as gross domestic product. Here, we examine expressions made on the online, global microblog and social networking service Twitter, uncovering and explaining temporal variations in happiness and information levels over timescales ranging from hours to years. Our data set comprises over 46 billion words contained in nearly 4.6 billion expressions posted over a 33 month span by over 63 million unique users. In measuring happiness, we construct a tunable, real-time, remote-sensing, and non-invasive, text-based hedonometer. In building our metric, made available with this paper, we conducted a survey to obtain happiness evaluations of over 10,000 individual words, representing a tenfold size improvement over similar existing word sets. Rather than being ad hoc, our word list is chosen solely by frequency of usage, and we show how a highly robust and tunable metric can be constructed and defended.
Check It Out Here
The PLoS Blogs Network
Diverse perspectives on science and medicine
EveryONE
Genomeboy
Gobbledygook
MIT SciWrite
Neuroanthropology
NeuroTribes
Obesity Panacea
PLoS Podcast
Speakeasy Science
Speaking of Medicine
Take as Directed
The Gleaming Retort
The Guest Blog
The Language of Bad Physics
The Official PLoS Blog
The Panic Virus
The Student Blog
This May Hurt a Bit
Tooth and Claw
Wonderland
Work In Progress
Sorry, for some reason blogger will not link to these blogs, please click here instead.
No comments:
Post a Comment