Welcome to HCV rewind, a weekly digest of news, research and a look at today's headlines.
We begin with this awesome PSA from HCV Support, a community of people dedicated to offering anonymous online support for hepatitis C.
Together we can defeat the Silent Dragon known as Hepatitis C
If you or a loved one has been affected by hepatitis C, support is here to help with anonymous online peer support, information and comradery.
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Research
This week we had another look at PROVIDE, an ongoing trial for Merck's boceprevir. The data was presented a few months ago at the International Liver Congress/annual meeting of the European Association for the Study of the Liver (EASL). In the trial boceprevir, used in combination with peginterferon and ribavirin was studied in null responders who failed treatment with peginterferon and ribavirin alone. Results in the small trial of 47 null responders is discussed, with an emphasis on cost , in the online article published at pharmacypracticenews.com.
The interim data resulted in SVR for 19 of the 47 participants, or 40%. In early trials null responders were not part of the bocepervir trials, although vertex’s phase III REALIZE trial did test telaprevir in 75 null responders, which produced a 33% SVR rate-(25/75). As mentioned in the article, there are no direct comparisons between the two drugs, but side-effects and dosing schedules are important factors in relation to cost, adherence and outcome.
Excerpt:
“Telaprevir has a much easier dosing schedule compared with boceprevir, with a three-month duration [compared with six to eight months for boceprevir] and one less blood draw,” she said. As for side effects, she noted that the study “called out the most significant [adverse reactions]—rash for telaprevir and neutropenia for boceprevir.”
Helping patients manage those adverse reactions can have a positive effect on compliance, Dr. Nguyen stressed. That in turn can be a cost-saver—“these are expensive drugs,” she noted. “But they have the potential for curing hepatitis C. So the role you can play as a pharmacist with patients’ adherence to therapy can save their lives.”
Prior Null Responders: Defined as people who achieved a less than 2 log10 reduction in hepatitis C virus at week 12 of a prior course of therapy
Read the complete article here....
On June 20th an article written by Alyson N. Fox and Ira M. Jacobson covering both PIs was downloaded over at NATAP. The paper also discusses future quadruple regimens using Peginterferon, ribavirin plus 2 DAAs, and the possible future of interferon-free therapy.
Link: Recent Successes and Noteworthy Future Prospects in the Treatment of Chronic Hepatitis C
Hep C Treatment Failure Can Still Mean Less Liver Inflammation
July 6 2012
This encouraging finding, published ahead of print by the American Journal of Gastroenterology, is based on data from an older 1.050-patient clinical trial dubbed the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) study.. Continue reading @ AIDS Med.
In case you missed it
TMC435 and daclatasvir interferon free Phase II trial to Commence Shortly
The phase II interferon-free combination study with TMC435 and daclatasvir will evaluate treatment-naive or previous null responder patients with HCV genotype 1a and 1b - The study will include approx. 180 patients and will evaluate a combination of TMC435 and daclatasvir, with or without Ribavirin, in four different cohorts for 12 or 24 weeks of treatment.
Listed at clinicaltrials.gov:
Study of Daclatasvir and TMC435 for Subjects With Genotype 1 Chronic Hepatitis C
New On The Blog
Hepatitis Clinical Trials- US and Canada
Hepatitis Clinical Trials - International
To learn more about Hepatitis C virus clinical trials or to find out if a study is enrolling patients in your area, please click here.
IL28B Genotyping in the Management of Chronic HCV
In the July issue of AGA Perspectives, Dr. Charlton investigates the use of IL28B genotying in protease inhibitors, boceprevir and telaprevir. The IL28B gene is related to how well a person will respond to treatment. There are three variations of IL28B genotypes: CC, CT, or TT. With the CC variation responding better to treatment with pegylated-interferon and ribavirin then CT or TT. For a better understanding of the IL28B gene click here. In the article Dr. Charlton reviews using IL28B genotyping to identify patients who are likely to achieve SVR; without protease inhibitors. As for interferon-free therapy? He writes; "Whether IL28B polymorphism will remain relevant in the context of IFN-free treatment protocols is not known and seems unlikely"
Excerpt:
Genotype 1 (and possibly 4)
If the decision of whether or not to treat HCV infection is dependent upon likelihood of SVR, IL28B genotyping should be considered (view figure at http://www.gastro. org/charlton83). In patients in whom treatment is planned, IL28B genotyping can be useful in guiding duration of treatment with PEG-IFN and RBV, as the C/C genotype confers a nine-fold increase in likelihood of rapid virological response (RVR).
Among those who do not achieve RVR, patients with C/C genotype are more than five times as likely to achieve SVR. Adding boceprevir and telaprevir to PEG-IFN and RBV reduces, but does not eliminate, the association between IL28B genotype and treatment outcome. In treatment naïve patients with HCV genotype-1 infection, IL28B genotype continues to be significantly predictive of SVR.....
Genotypes 2 and 3 are also discussed, click here to view article...
Interferon-Free Treatments Are Imminent for Hep C
July 3, 2012
Composing one half or one third of the currently prescribed Hepatitis C therapy regimens, interferon is a fierce drug. Due to an inability to tolerate interferon, many people are deemed "non-responders" to Hepatitis C treatment. Luckily, there are a handful of interferon-free treatment regimens in trials that are showing great promise for previous non-responders....Continue reading....
‘My Cross to Bear,’ Gregg Allman’s Memoir
By DAVID KIRBY
Published: July 6, 2012
Reading this book is like sitting on a porch with a garrulous scalawag who gives equal time to his dumb decisions and fantastic luck. Only the rascal talking your ear off is Gregg Allman, Rock and Roll Hall of Famer and founding member of the Allman Brothers Band
With “so much energy, so much drive and so much want-to,” the penniless Allmans and their bandmates began to cut best-selling albums and fill clubs. Then came the hard times: the deaths of Duane Allman and the bassist Berry Oakley in eerily similar motorcycle accidents, the failed relationships, the hepatitis C that Gregg Allman attributes to an unsanitary tattoo needle.
Continue reading @ The New York Times
Liver Cancer
Scientists develop mouse model that could lead to new therapies for liver cancer
Richmond, Va. (July 6, 2012) – Researchers have created the first mouse model demonstrating the role of a cancer promoting gene, Astrocyte elevated gene-1 (AEG-1), in hepatocellular carcinoma, or liver cancer. The mouse model represents a critical step in understanding the molecular mechanisms of liver cancer progression and could lead to novel therapies for the disease.
Insights from the mouse model were recently published in the journal Hepatology by a team of researchers led by Devanand Sarkar, M.B.B.S., Ph.D., Harrison Scholar at Virginia Commonwealth University (VCU) Massey Cancer Center, Blick Scholar and assistant professor in the Department of Human and Molecular Genetics and member of the VCU Institute of Molecular Medicine (VIMM) at VCU School of Medicine. AEG-1 was originally cloned in the lab of the study's co-author, Paul B. Fisher, M.Ph., Ph.D., Thelma Newmeyer Corman Endowed Chair in Oncology Research and program co-leader of Cancer Molecular Genetics at Massey, professor and chair of the Department of Human and Molecular Genetics and director of VIMM.
"My colleagues and I have been researching the role of AEG-1 in cancer development for several years and have shown it is linked to a diverse array of cancers, including liver cancer," says Sarkar. "This mouse model represents a breakthrough in our ability to test and translate our laboratory findings."
The mouse model gave the researchers a deeper understanding of the role of AEG-1 in liver cancer. Sarkar and his team confirmed AEG-1 overexpression significantly accelerated the progression of liver cancer. It also caused steatosis, or fatty liver, a mechanism that promotes inflammation and cancer progression. In addition, the mouse model substantiated laboratory findings that suggested that AEG-1 plays a role in protecting liver cancer cells from chemotherapeutic drugs and alters tumor angiogenesis, or the way that new blood vessels are formed within the tumor.
The researchers plan to use the model to further explore the molecular mechanisms by which AEG-1 promotes liver cancer, including the role of AEG-1 in fat metabolism and obesity-related diseases.
"This model moves us forward in the research process by allowing us to test a variety of compounds that could inhibit AEG-1 and prevent the development and progression of liver cancer," says Sarkar. "Ultimately, we hope our efforts will lead to new therapies and save lives."
Read more @ EurekAlert
Hepatitis B
CDC Issues Updated Recommendations on Managing HBV-Infected Providers, Students
CDC guidelines for managing healthcare providers and medical students who are infected with hepatitis B (HBV) have been updated and published in MMWR.
Last updated in 1991, the new guidelines no longer recommend that patients be routinely informed of a provider's or student's HBV status. Such disclosure "might actually be counterproductive to public health," according to MMWR.
Another change: HBV DNA serum levels, rather than hepatitis B e-antigen status, should be used to monitor infectivity.
The new guidelines reaffirm the 1991 recommendation that HBV infection should not disqualify infected individuals from practicing surgery, dentistry, or medicine.
LINK(S):
MMWR article (Free)
Published in Physician's First Watch July 6, 2012
Stem Cells
RNL Bio is a South Korean stem cell company known for banking adult autologous stem cells and shipping processed, cultured, and expanded stem cells to clinics located in China, Japan, and Mexico. At least 10,000 individuals reportedly have received infusions or injections of adult autologous stem cells at clinics affiliated with RNL Bio. Numerous health researchers and journalists accuse RNL Bio of promoting stem cell tourism to countries with inadequate regulation of stem cells and unlawfully providing clinically unproven stem cell procedures to patients at several South Korean health care facilities.
Researchers use stem cells to reverse diabetes in a mouse model
By Insidermedicine
Transplanting human stem cells into diabetic mice successfully reversed the condition in research published online ahead of print in Diabetes.
View all videos @ insidermedicine.com
Artificial Blood Vessels
View all videos @ insidermedicine.com
Artificial Blood Vessels
3D-printed sugar network to help grow artificial liver
Researchers have moved a step closer to
creating a synthetic liver, after a US team created a template for blood vessels
to grow into, using sugar.
Scientists have long been experimenting with the 3D printing of cells and blood vessels, building up tissue structure layer by layer with artificial cells.
But the synthetically engineered cells often die before the tissue is formed
Scientists have long been experimenting with the 3D printing of cells and blood vessels, building up tissue structure layer by layer with artificial cells.
But the synthetically engineered cells often die before the tissue is formed
Continue reading.....
UK-Regenerative Medicine
Taking tissue regeneration beyond the state-of-the-art
03 Jul 2012 15:26:44.110
PA 195/12
The University of Nottingham has begun the search for a new class of injectable materials that will stimulate stem cells to regenerate damaged tissue in degenerative and age related disorders of the bone, muscle and heart.
The work, which is currently at the experimental stage, could lead to treatments for diseases that currently have no cure. The aim is to produce radical new treatments that will reduce the need for invasive surgery, optimise recovery and reduce the risk of undesirable scar tissue.
The research, which brings together expertise in The University of Nottingham’s Malaysia Campus (UNMC) and UK campus, is part of the Rational Bioactive Materials Design for Tissue Generation project (Biodesign). This €11m EU funded research project which involves 21 research teams from across Europe is made up of leading experts in degenerative disease and regenerative medicine.
Continue reading..........
HIV
The University of Nottingham has begun the search for a new class of injectable materials that will stimulate stem cells to regenerate damaged tissue in degenerative and age related disorders of the bone, muscle and heart.
The work, which is currently at the experimental stage, could lead to treatments for diseases that currently have no cure. The aim is to produce radical new treatments that will reduce the need for invasive surgery, optimise recovery and reduce the risk of undesirable scar tissue.
The research, which brings together expertise in The University of Nottingham’s Malaysia Campus (UNMC) and UK campus, is part of the Rational Bioactive Materials Design for Tissue Generation project (Biodesign). This €11m EU funded research project which involves 21 research teams from across Europe is made up of leading experts in degenerative disease and regenerative medicine.
Continue reading..........
HIV
FDA Approves First Rapid, Take-Home HIV Test
The OraQuick test detects the presence of HIV antibodies using a mouth swab and returns a result in 20 to 40 minutes.
A home HIV test called OraQuick has been approved by the FDA. The test can be taken at home, providing results in approximately 30 minutes. The idea behind OraQuick is to make testing accessible to those who do not have the means to see a doctor. Testing is a chief means of slowing new infections, which have held steady at about 50,000 per year...read more..
Couples Tested for HIV Together
AIDS Project Rhode Island recently began offering HIV tests for couples. The program, called Testing Together, allows couples to come in for testing together and get their HIV test results minutes later, while sitting side-by-side. At most clinics, a person who asks if his or her partner can be there when learning the test result is denied because ... (more)
Transplants
Transplants
(DALLAS) -- After the wrong patient received a kidney last week, Methodist Dallas Medical Center is now suspending its kidney and pancreas donation program.
Though the kidney was compatible with the patient, the fact that it went to the wrong person on the organ donation list, is an indication that something went wrong.
"Obviously, the process was not followed correctly and that's what we want to make sure doesn't happen again," Kathleen Beathard, a Methodist Dallas spokeswoman said, according to ABC News television affiliate WFAA in Dallas.
The person responsible for the oversight has been terminated, and the patients awaiting transplants have been made aware of the program's suspension.
Beathard noted that if patients become eligible for transplants now, the surgeries can be done at other hospitals, according to WFAA. Until then, Methodist Dallas has instituted a corrective action plan to ensure the incident doesn't happen again.
The kidney transplant program at Methodist Dallas hopefully will resume soon, Beathard said.
ABC News Radio
Four give life to 10 in death, through organ donation
India-While patients suffering from kidney ailments can survive on dialysis, there is no hope - other than transplantation - for those in advanced stages of liver diseases including cirrhosis of the liver that is an irreversible condition.
Continue reading....
Local comics joining forces to help gravely ill MacDonald
MacDonald, 57, has been a fixture on the Canadian comedy scene for more than 30 years. He was diagnosed with Hepatitis C last year -- perhaps a result of hard-drug use early in his career -- and his condition quickly deteriorated a few months ago when his liver and kidneys shut down.
Read the story at The Winnipeg Free Press
HCV Transmission - Clinical Setting
New Hampshire Hospital Faces Numerous Lawsuits For Hepatitis C Outbreak
July 6, 2012
New Hampshire’s Exeter Hospital is facing at least a dozen a lawsuits, with five new cases filed this week, after close to 60 patients had contracted hepatitis C while undergoing treatment at the hospital’s cardiac catheterization lab.
The hospital announced Monday (July 2) that 27 people so far had contracted the disease while under their care. However, close to 60 former patients have filed suit against Exeter as of the beginning of July, of which 47 have already signed on to a class-action lawsuit. Twelve others have filed individual lawsuits.
Cases of hep-C were first reported in May, and state health officials the following month said the outbreak was most likely the result of drug diversion — misuse of prescription drugs for non-medical purposes — by a hospital employee.
Drug diversion has become a major problem among health care workers, who may use narcotics prescribed for patients and then pass on diseases through contaminated syringes. State officials are still investigating whether the employee was the source of the outbreak.
Drug diversion has led to hepatitis outbreaks in at least three hospitals across the country since 2001, according to information gleaned by the US Centers for Disease Control and Prevention (CDC).
Hepatitis C causes inflammation of the liver and can lead to chronic infection. CDC data has shown that 13 healthcare-associated hep-C outbreaks occurred between 2008 and 2011. More than a hundred people were infected during those outbreaks. Two of those cases involved drug diversion: one in 2009 in Colorado and another in 2010 in Florida.
Mark Abramson, a medical malpractice attorney from Abramson Brown & Dugan of Manchester, NH, is handling a total of 10 clients involved in the recent outbreak, including 4 who were named in lawsuits filed between the end of June and Monday, July 2.
Portsmouth attorney Michael Rainboth, of the firm Coughlin, Rainboth, Murphy & Lown, also announced that he has filed suit on behalf of two clients infected by the Exeter Hospital hepatitis C outbreak.
So far, 26 patient cases and one employee case have been confirmed. The only known connection between them stems from the facility’s cardiac catheterization lab.
The NH Attorney General and the US Attorney’s Office have both said they are now investigating the hospital and the situation to determine whether a criminal act has occurred.
Many of those who filed litigation have yet to be tested positive for the virus. Some of those named in the class-action suit are awaiting test results, or have already tested negative, but are still seeking damages for being caught up in the mayhem.
Exeter said that it had contacted all patients who were treated in the cardiac catheterization lab between October 2010 and May 2012, urging them to get tested for hep-C.
“Exeter Hospital remains focused on supporting all of our patients and their families who required testing during this difficult time and has now completed the blood draws or scheduled appointments for over 1,000 of the identified patients who had an invasive procedure at the Cardiac Catheterization Unit and its dedicated recovery area between October 1, 2010 and May 25, 2012.
The hospital has also contacted all patients who were identified by the state as needing a one month follow-up test due to the recent timing in the Cardiac Catheterization Unit and its dedicated recovery area, and have begun scheduling appointments for these patients,”it said in a news release
The class-action lawsuit was filed last month in Rockingham County Superior Court by Concord attorney Peter McGrath.
McGrath told Foster’s Daily Democrat in a June 20 interview that 47 people had signed on to the lawsuit, including six who had tested positive for hep-C. He said approximately 20 more were awaiting test results.
Fosters.com was provided with copies of the lawsuits brought against Exeter. The documents show that four of the new plaintiffs represented by Abramson include an 82-year-old Exeter man, a 67-year-old man from Kingston, a 52-year-old married man from Raymond, and a 46-year-old man from Newmarket, NH.
Abramson said in an email earlier this week that all ten clients under his wing have tested positive for the disease.
Kevin Callahan, president and CEO of Exeter Health Resources made a public apology for the outbreak on June 14 and discussed, along with Dr. Richard Hollister, chief of medicine, how the facility is handling the situation, which can be viewed here.
The hospital announced Monday (July 2) that 27 people so far had contracted the disease while under their care. However, close to 60 former patients have filed suit against Exeter as of the beginning of July, of which 47 have already signed on to a class-action lawsuit. Twelve others have filed individual lawsuits.
Cases of hep-C were first reported in May, and state health officials the following month said the outbreak was most likely the result of drug diversion — misuse of prescription drugs for non-medical purposes — by a hospital employee.
Drug diversion has become a major problem among health care workers, who may use narcotics prescribed for patients and then pass on diseases through contaminated syringes. State officials are still investigating whether the employee was the source of the outbreak.
Drug diversion has led to hepatitis outbreaks in at least three hospitals across the country since 2001, according to information gleaned by the US Centers for Disease Control and Prevention (CDC).
Hepatitis C causes inflammation of the liver and can lead to chronic infection. CDC data has shown that 13 healthcare-associated hep-C outbreaks occurred between 2008 and 2011. More than a hundred people were infected during those outbreaks. Two of those cases involved drug diversion: one in 2009 in Colorado and another in 2010 in Florida.
Mark Abramson, a medical malpractice attorney from Abramson Brown & Dugan of Manchester, NH, is handling a total of 10 clients involved in the recent outbreak, including 4 who were named in lawsuits filed between the end of June and Monday, July 2.
Portsmouth attorney Michael Rainboth, of the firm Coughlin, Rainboth, Murphy & Lown, also announced that he has filed suit on behalf of two clients infected by the Exeter Hospital hepatitis C outbreak.
So far, 26 patient cases and one employee case have been confirmed. The only known connection between them stems from the facility’s cardiac catheterization lab.
The NH Attorney General and the US Attorney’s Office have both said they are now investigating the hospital and the situation to determine whether a criminal act has occurred.
Many of those who filed litigation have yet to be tested positive for the virus. Some of those named in the class-action suit are awaiting test results, or have already tested negative, but are still seeking damages for being caught up in the mayhem.
Exeter said that it had contacted all patients who were treated in the cardiac catheterization lab between October 2010 and May 2012, urging them to get tested for hep-C.
“Exeter Hospital remains focused on supporting all of our patients and their families who required testing during this difficult time and has now completed the blood draws or scheduled appointments for over 1,000 of the identified patients who had an invasive procedure at the Cardiac Catheterization Unit and its dedicated recovery area between October 1, 2010 and May 25, 2012.
The hospital has also contacted all patients who were identified by the state as needing a one month follow-up test due to the recent timing in the Cardiac Catheterization Unit and its dedicated recovery area, and have begun scheduling appointments for these patients,”it said in a news release
The class-action lawsuit was filed last month in Rockingham County Superior Court by Concord attorney Peter McGrath.
McGrath told Foster’s Daily Democrat in a June 20 interview that 47 people had signed on to the lawsuit, including six who had tested positive for hep-C. He said approximately 20 more were awaiting test results.
Fosters.com was provided with copies of the lawsuits brought against Exeter. The documents show that four of the new plaintiffs represented by Abramson include an 82-year-old Exeter man, a 67-year-old man from Kingston, a 52-year-old married man from Raymond, and a 46-year-old man from Newmarket, NH.
Abramson said in an email earlier this week that all ten clients under his wing have tested positive for the disease.
Kevin Callahan, president and CEO of Exeter Health Resources made a public apology for the outbreak on June 14 and discussed, along with Dr. Richard Hollister, chief of medicine, how the facility is handling the situation, which can be viewed here.
Source: redOrbit (http://s.tt/1h3pO)
Big Pharma
R-Pharm entered into a licensing agreement with MSD for rights to a novel investigational, hepatitis C once-daily protease inhibitor, narlaprevir.
Merck &Co and R-Pharm announce collaboration
Posted on 06 July 2012
R-Pharm entered into a licensing agreement with MSD for rights to a novel investigational, hepatitis C once-daily protease inhibitor, narlaprevir.
The agreement provides an opportunity for R-Pharm to conduct late-stage clinical trials in Russia, which is among the goals of the Russian government’s Pharma 2020 initiative.
Under the terms of the agreement, R-Pharm gains rights to develop and commercialize narlaprevir in Russia and the Commonwealth of Independent States.
R-Pharm will pay Merck,an upfront payment and undisclosed royalties on sales of narlaprevir.
Merck has retained the right to co-promote narlaprevir in these regions and
retains rights to the drug outside of Russia and the CIS countries.
Narlaprevir is a second generation NS3 serine protease inhibitor developed by Merck.
Narlaprevir is a second generation NS3 serine protease inhibitor developed by Merck.
For further deal information visit
Current Agreements (subscription
required)
Idenix: New HCV Drug Could Be A Blockbuster
Cris Frangold
Seeking Alpha
Idenix Pharmaceuticals, Inc. (IDIX) recently announced encouraging initial results from Phase IIb results for the treatment - namely, IDX184 and IDX719 - of the hepatitis C virus (HCV). Some reports about HCV say that it affects more than 170 million people globally, including over 4 million Americans. The global market for an effective treatment could reach as high as $100 billion by the year 2020...........Continue reading....
Cris Frangold
Seeking Alpha
Idenix Pharmaceuticals, Inc. (IDIX) recently announced encouraging initial results from Phase IIb results for the treatment - namely, IDX184 and IDX719 - of the hepatitis C virus (HCV). Some reports about HCV say that it affects more than 170 million people globally, including over 4 million Americans. The global market for an effective treatment could reach as high as $100 billion by the year 2020...........Continue reading....
By JEANNE WHALEN
(WSJ) The host of a sex-advice radio show received payments totally $275,000 from GlaxoSmithKline PLC to promote the antidepressant Wellbutrin in the late 1990s.
He told listeners he prescribes it and other medications to depressed patients because it "may enhance or at least not suppress sexual arousal" as much as other antidepressants do...Read the article @ WSJ
How Not to Get Big Pharma to Change Its Ways
Earlier this week the Justice Department announced a $3 billion settlement of criminal and civil charges against pharma giant GlaxoSmithKline (GSK) — the largest pharmaceutical settlement in history — for improper marketing prescription drugs in the late 1990s to the mid-2000s.
The charges are deadly serious. Among other things, Glaxo was charged with promoting to kids under 18 an antidepressant approved only for adults; pushing two other antidepressants for unapproved purposes, including remedying sexual dysfunction; and, to further boost sales of prescription drugs, showering doctors with gifts, consulting contracts, speaking fees, even tickets to sporting events...Continue reading..
Biolex Therapeutics files for $38M bankruptcy
Chris BagleyThe charges are deadly serious. Among other things, Glaxo was charged with promoting to kids under 18 an antidepressant approved only for adults; pushing two other antidepressants for unapproved purposes, including remedying sexual dysfunction; and, to further boost sales of prescription drugs, showering doctors with gifts, consulting contracts, speaking fees, even tickets to sporting events...Continue reading..
Biolex Therapeutics files for $38M bankruptcy
Biolex recently had faced an increasingly daunting task of raising money to develop its Locteron drug for hepatitis C. The company had touted the drug as likely to have milder side effects and more convenient dosing than existing hepatitis C treatments.
Biolex shrank from 70 employees at its peak to about 13 in February. CFO Dale Sander told Triangle Business Journal that month that the company was considering a sale as one of several alternatives to continue Locteron's development...Continue reading.....
Pfizer yanks breast, colon claims for Centrum vitamins
NEW YORK/WASHINGTON |
(Reuters) - Pfizer Inc, bowing to allegations of deceptive advertising lodged by a consumer watchdog group, has agreed to drop "breast health" and "colon health" claims from the labels of its widely used Centrum multivitamin supplements.
Although Pfizer said it disagreed with complaints lodged by the nonprofit Center for Science in the Public Interest (CSPI), it agreed to remove the claims from some Centrum product labels over the next six months and to withdraw them from websites and advertising within 30 days.
Watchdog groups such as CSPI have taken the lead in recent years in policing the accuracy of supplements' health claims amid widespread criticism that the U.S. Food and Drug Administration is not doing enough to help consumers navigate conflicting information. The Government Accountability Office has also said the FDA needs more power to regulate supplements.
The center sent a lengthy letter to Pfizer Chief Executive Ian Read in April alleging that separate Centrum products carried deceptive claims on their labels - that they support "energy and immunity," "heart health", "eye health," "breast health, "bone health" and "colon health."
The group threatened to sue Pfizer, which acquired the Centrum franchise through its purchase of rival U.S. drugmaker Wyeth three years ago, unless the claims were stripped from labels of the products.
Pfizer agreed to remove the claims related to breast health and colon health, and to modify language relating to heart health and energy.
"The company disagrees with CSPI's concerns, but has agreed to make these changes in order to fully resolve the issues raised by the organization," Pfizer said in a statement provided on Thursday.
A company spokesman declined to elaborate when asked about the scientific basis for the various health claims.
Labels for Centrum Ultra Women's and Centrum Silver Women's multivitamin supplements stated that those products supported "breast health." Likewise, labels for Centrum Ultra Men's and Centrum Silver Ultra Men's supplements claimed to support colon health.
"Those claims of breast and colon health implied that the supplements would prevent breast and colon cancer - disease prevention claims that supplement manufacturers can't legally make," the watchdog group said in a release.
The group said Pfizer partly based the breast and colon claims on the presence of vitamin D in the products, despite inconsistent or inconclusive evidence of vitamin D's protective role against breast and colon cancer.
Various other Centrum products will continue to claim they foster bone health and eye health, despite CSPI's earlier objections to the claims.
"A settlement is, by its nature, something where neither side gets all it wants," said Stephen Gardner, director of litigation for the center. "Once Pfizer agreed to drop the breast and colon cancer claims, we felt that that was too important to let things fall apart over eye and bone health."
Gardner said the vitamin claims might be interpreted as helping the structure of bone and eyes, a stronger argument than preventing complications.
For Centrum products claiming "heart health," labels and advertising will now note they are "not a replacement for cholesterol-lowering drugs." For products promoting "energy," language will be added to show they do not directly provide an energy boost, but instead support metabolic function, the consumer group said.
Many other companies continue to make unsubstantiated health claims for supplements, Gardner said.
"It's a tremendous problem. The supplement companies want consumers to buy their supplements instead of FDA-approved actual drugs. So they make claims of disease prevention."
(Editing by Andre Grenon)
Healthy You
.
How Much Vitamin D?
By Health Day
Vitamin D is essential to bone strength. Too little can lead to osteoporosis...or brittle bones.
The U.S. Preventive Services Task Force recently advised postmenopausal women against taking low dose calcium and vitamin D saying there was no evidence it would help prevent breaks.
Now, a new study, just published in the New England Journal of Medicine, looks at the effectiveness of high doses of Vitamin D, and whether it wards off fractures in women age 65 and over.
A group of researchers at the University of Zurich poured over 11 different Vitamin D studies, which included more than 30-thousand women.
The conclusion ...that vitamin D, in high doses, provides a "somewhat favorable" ability to prevent nonvertebral fractures in women in this age group
These findings support the most recent recommendation from the Institute of Medicine that women 65 years of age or older take a high dose- 800 International Units- of vitamin D every day.
Patients, and Their Meds, Need to Keep Cool
By Kristina Fiore, Staff Writer, MedPage Today
Temperatures above 86 degrees Fahrenheit can render some medications useless, according to Robert Glatter, MD, an emergency medicine physician at Lenox Hill Hospital in New York.
"I've noticed an increase in the number of ED visits related to mental illness in the recent heatwave," Glatter told MedPage Today, noting that most complaints have been related to anxiety or mood swings.
He said the effects could be tied to improper storage of medications in the heat, which may affect the bioavailability of the active agents in these drugs. The U.S. Pharmacopeia, a medication standards agency, states that drugs generally should be stored at room temperature -- between 68 and 77 degrees Fahrenheit -- with only brief excursions to temps as low as 59 degrees or as high as 86 degrees.
Above or below that, there's no guarantee medications will work, the agency says.
Add to decreased efficacy the common problem of dehydration on high-heat days, and that makes for packed ED departments, Glatter said.
He said patients should be sure to keep their prescriptions with them in cool places, paying particular mind to where they're stored during travel. That means keeping medications in pockets or purses when luggage gets tossed into cargo holds that might overheat, he said.
Sweat Blockers
But patients also have to be careful even when their medications are stored properly, Glatter added, since some drugs increase dehydration or interfere with the body's own cooling mechanisms.
Glatter says he's seen a "slight increase in the number of patients coming to the ED with migraine headaches who tend to get overheated," typically because the drugs they take to treat their condition prevent them from sweating.
In particular, the triptans, such as sumatriptan (Imitrex), along with other neurologic or psychiatric medications, can inhibit the body's natural cooling process by interfering with thermal control messaging between the brain and the rest of the body, according to David W. Claypool, MD, an emergency medicine physician at the Mayo Clinic in Rochester, Minn.
"Any medications that affect water intake or how our blood vessels work make patients particularly susceptible," Claypool told MedPage Today. Topping that list is blood pressure medications, especially beta-blockers like metoprolol (Toprol), which impact cooling through its effects on slowing heart rate, Glatter said.
Seizure medications and antihistamines like Claritin and Benadryl, as well as Parkinson's disease medications, also work to inhibit sweat production.
And diuretics, which sop up extra water in the body, are among the top drugs that lead to dehydration, Glatter added.
Patients on any of these medications "need to drink additional fluids and stay out of the sun as much as possible," he said.
No Relief
Not even the anticipated severe storms sweeping across the Great Plains and Midwest later this week are expected to bring any relief from the heat, according to the National Weather Service.
Forecasts are calling for excessive heat for most of the nation through the weekend, with temperatures above 90 and some topping 100 expected to bear down on much of the U.S. during that time.
That's bad news for people living in areas that have already been ravaged by severe thunderstorms that have already left millions without power.
According to several reports, 18 people were killed since last weekend when excessive heat and storms churned across most of the country.
Older patients and those without access to resources such as air conditioning are at greatest risk of heat-induced health problems, clinicians say. These patients need to be evacuated to cooling centers or other settings that will keep them cool and hydrated.
Another important message for all patients, Glatter said: "Don't just drink water when you're thirsty. At that point, you're already behind" and at risk of serious complications of dehydration.
Around The World
Unknown Disease Killing Children Across Cambodia, WHO Says
By Jason Gale - Jul 6, 2012 12:26 AM PT
Victims of a disease that’s killed dozens of children in Cambodia were from more than half the country’s provinces, a World Health Organization official said. The first 57 patients were from 14 of Cambodia’s 24 provinces, with most coming from the southeastern provinces of Kampong Cham, Kampong Speu and Prey Veng, said Joy Rivaca Caminade, a technical officer with WHO’s Regional Office for the Western Pacific in Manila. The Ministry of Health was first alerted to the cases by Kantha Bopha Children’s Hospital in the capital, Phnom Penh, Caminade said in an e-mail today.
Health officials are searching for the cause of the deaths, which may be the result of a combination of different diseases, according to Caminade. Surveillance in the Southeast Asian nation hasn’t picked up anything of this scale in recent years, she said. So far, there is no evidence of clustering of cases that could indicate that it’s spreading from person to person....Read more @ Bloomberg
For Your Viewing Pleasure
How Do Pain Relievers Work?
Published on Jun 26, 2012 by TEDEducation
Some people take aspirin or ibuprofen to treat everyday aches and pains, but how exactly do the different classes of pain relievers work? Learn about the basic physiology of how humans experience pain, and the mechanics of the medicines we've invented to block or circumvent that discomfort.
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